At CAFC, Nintendo wins 101 judgment on the pleadings

This was an "Alice" case:


In March 2015, Nintendo filed a motion for judgment
on the pleadings, asserting that the claims were ineligible
under 35 U.S.C. § 101. Section 101 provides that
“[w]hoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or
any new and useful improvement thereof, may obtain a
patent therefor . . . .” There is an exception to that general
principle: subject matter directed to laws of nature,
natural phenomena, or abstract ideas is not patenteligible.
Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347,
2354 (2014). The Supreme Court has established a two-
step test to determine whether patent claims are directed
to ineligible subject matter. In the first step, “we determine
whether the claims at issue are directed to one of
those patent-ineligible concepts.” Id. at 2355. If the
answer in step one is yes, “we then ask, ‘[w]hat else is
there in the claims before us?’” Id. (quoting Mayo Collaborative
Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289,
1297 (2012)). In other words, step two asks whether the
patent claims an “‘inventive concept’ sufficient to ‘transform’
the claimed abstract idea into a patent-eligible
application.” Id. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298).




Here


Under the first step of Alice, we decide whether the
claims are directed to ineligible subject matter, such as an
abstract idea. McRO, 837 F.3d at 1312; Internet Patents
Corp. v. Active Network, Inc., 790 F.3d 1343, 1346 (Fed.
Cir. 2015). The inquiry often is whether the claims are
directed to “a specific means or method” for improving
technology or whether they are simply directed to an
abstract end-result. McRO, 837 F.3d at 1314. If the
claims are not directed to an abstract idea, the inquiry
ends. Thales Visionix Inc. v. United States, 850 F.3d
1343, 1349 (Fed. Cir. 2017).

(...)

We find that claim 1 is directed to the abstract idea of
encoding and decoding image data. It claims a method
whereby a user displays images on a first display, assigns
image codes to the images through an interface using a
mathematical formula, and then reproduces the image
based on the codes. See J.A. 35 (col. 1 ll. 23–40). This
method reflects standard encoding and decoding, an
abstract concept long utilized to transmit information. Cf.
Intellectual Ventures I LLC v. Capital One Fin. Corp., 850
F.3d 1332, 1340–41 (Fed. Cir. 2017) (organizing, displaying,
and manipulating data encoded for human- and
machine-readability is directed to an abstract concept).
Morse code, ordering food at a fast food restaurant via a
numbering system, and Paul Revere’s “one if by land, two
if by sea” signaling system all exemplify encoding at one
end and decoding at the other end. Even the ’303 patent
describes “a common technique for synthesizing single
images of faces involv[ing] horizontally dividing the image
of a face into bands for different features,” such that
“[p]aper strips containing exemplary features [can] then
be combined to form a composite drawing of a face.” J.A.
27 (col. 1 ll. 37–43).

RecogniCorp invokes Diamond v. Diehr, 450 U.S. 175
(1981), to support its argument that claiming the use of a
mathematical formula does not necessarily render a
patent ineligible. RecogniCorp is correct. In Diehr, the
Supreme Court held that despite a method claim’s recitation
of a mathematical formula, “a physical and chemical
process for molding precision synthetic rubber products
falls within the § 101 categories of possibly patentable
subject matter.” Id. at 184. In confirming patentability,
the Supreme Court focused not on the presence of a
claims as a whole. Id. at 192 (“[A] claim containing a
mathematical formula” satisfies § 101 when it “implements
or applies that formula in a structure or process
which, when considered as a whole, is performing a function
which the patent laws were designed to protect.”).
Here, the relevant inquiry does not turn one way or the
other just on claim 1’s use of multiplication. See J.A. 35
(’303 Reexamination Certificate, col. 1 ll. 34–38). Rather,
the focus is on the claim as a whole. Diehr is distinguishable
because, outside of the math, claim 1 of the ’303
patent is not directed to otherwise eligible subject matter.
Adding one abstract idea (math) to another abstract idea
(encoding and decoding) does not render the claim nonabstract.
RecogniCorp argues that, as in Enfish, “the district
court mischaracterized the invention using an improperly
high level of abstraction that ignored the particular
encoding process recited by the claims.” Appellant’s Op.
Br. 11. In Enfish, we warned that “describing the claims
at such a high level of abstraction and untethered from
the language of the claims all but ensures that the exceptions
to § 101 swallow the rule.” 822 F.3d at 1337. But
the district court did not make that mistake regarding the
’303 patent. The claims of the ’303 patent are clearly
directed to encoding and decoding image data. Unlike
Enfish, claim 1 does not claim a software method that
improves the functioning of a computer. See id. It claims
a “process that qualifies as an ‘abstract idea’ for which
computers are invoked merely as a tool.” Id. at 1336.


Step 2:


We proceed to the second step of Alice because the
’303 patent claims are directed to an abstract idea.

(...)

RecogniCorp argues that the claims of the ’303 patent
contain an inventive concept sufficient to render them
patent-eligible. Specifically, it contends that the combination
of claim elements, i.e., the “particular encoding
process using the specific algorithm disclosed” in the
patent “transforms” the abstract idea into a patentable
invention. RecogniCorp also points out the “facial feature
element codes” and “pictorial entity symbols” disclosed in
the ’303 patent claims. We find that these claim elements
do not transform the nature of the ’303 patent claims into
a patent-eligible application. McRO, 837 F.3d at 1312.


In DDR Holdings, LLC v. Hotels.com, L.P., we found
that the patent claims satisfied Alice step two because
“the claimed solution amounts to an inventive concept for
resolving [a] particular Internet-centric problem.” 773
F.3d 1245, 1259 (Fed. Cir. 2014). Claim 1 of the ’303
patent contains no similar inventive concept. Nothing
“transforms” the abstract idea of encoding and decoding
into patent-eligible subject matter. Alice, 134 S. Ct. at
2357. Nor does the presence of a mathematical formula
dictate otherwise. Claims that are directed to a nonabstract
idea are not rendered abstract simply because
they use a mathematical formula. Diehr, 450 U.S. at 187.
But the converse is also true: A claim directed to an
abstract idea does not automatically become eligible
merely by adding a mathematical formula. See, e.g.,
Clarilogic, Inc. v. FormFree Holdings Corp., __ F. App’x
__, 2017 WL 992528, at *3 (Fed. Cir. Mar. 15, 2017). As
we explained above, claim 1 is directed to the abstract
idea of encoding and decoding. The addition of a mathematical
equation that simply changes the data into other
forms of data cannot save it.


In BASCOM Global Internet Services, Inc. v. AT&T
Mobility LLC, the patent owner “alleged that an inventive
concept can be found in the ordered combination of claim
limitations that transform the abstract idea of filtering
content into a particular, practical application of that
abstract idea.” 827 F.3d 1341, 1352 (Fed. Cir. 2016). We
found the allegation sufficient to survive a motion to
dismiss, where all facts had to be construed in the patent
owner’s favor. Id. Here, RecogniCorp has not alleged a
particularized application of encoding and decoding image
data. Indeed, claim 1 does not even require a computer;
the invention can be practiced verbally or with a telephone.
J.A. 28 (col. 4 ll. 59–63); J.A. 32 (col. 11 ll. 53–59).
Independent claim 36 claims the use of a computer, but it
does exactly what we have warned it may not: tell a user
to take an abstract idea and apply it with a computer.

Versata Dev. Grp., Inc. v. SAP Am., Inc., 793 F.3d 1306,
1332 (Fed. Cir. 2015).
In sum, the claims of the ’303 patent lack an inventive
concept that transforms the claimed subject matter from
an abstract idea into a patent-eligible application. Alice,
134 S. Ct. at 2357.

CAFC denies Nichia an injunction; patentee licensing weighs against a finding of irreparable harm

The CAFC affirmed Judge Gilstrap of ED Texas in the Nichia case,
so no injunction for Nichia but infringement still stands:


Nichia Corporation sued Everlight Electronics Co.,
LTD., Everlight Americas, INC., and Zenaro Lighting,
Inc. (collectively, “Everlight”) for infringement of three of
its patents. Following a bench trial, the district court
found Everlight infringed all three patents and had not
proved them invalid. The court denied, however, Nichia’s
request for a permanent injunction against Everlight.
Nichia appeals the district court’s refusal to enter an
injunction against Everlight. Everlight cross-appeals the
court’s judgment that it infringes Nichia’s patents and
that it failed to prove the patents invalid. We affirm.


Of Everlight's cross-appeal of the infringement finding:


We review the court’s findings of fact for clear error
and its legal conclusions de novo. Allergan, Inc. v. Apotex
Inc., 754 F.3d 952, 961 (Fed. Cir. 2014).
(...)
Because we agree with the court’s construction, and
because Everlight does not challenge the court’s finding of
infringement under that construction, we affirm the
court’s finding that the accused products meet this limitation.



As to Everlight's invalidity challenge:



The court found that a person of ordinary skill would
not have considered Glenn or Sanyo to modify Hitachi
because “the different considerations in the design and
manufacture of electronic and optoelectronic [e.g., LED]
devices result in substantial differences in the manufacturing
processes and materials used in the different
technologies,” and “a change in the design or manufacture
of an LED or other optoelectronic device requires the
consideration of factors—including factors such as light
emission, and the effects of heat and emitted radiation on
different resins and other materials—that are not relevant
to the design and manufacture of electronic semiconductor
devices.” Id. at *21.


Also



But the court found that a person of ordinary skill in
the art would have had no motivation to modify Nitta in
light of Waitl. We agree. The court found that the references
disclose different structures, resolve dissimilar
problems, and propose dissimilar solutions. Id. at *51–53.
The court’s conclusion derives further support from its
earlier finding that artisans in this field face myriad
design challenges because small design changes may
cause unpredictable results and because design considerations
often pull in multiple directions. Id. at *4. We
determine that the court’s finding on motivation to combine
is not clearly erroneous. We thus affirm the district
court’s conclusion that Everlight failed to prove the ’870
patent invalid as obvious.


As to the denial of Nichia's request for an injunction:


We review a district court’s grant or denial of a permanent
injunction for an abuse of discretion. Robert
Bosch LLC v. Pylon Mfg. Corp., 659 F.3d 1142, 1149 (Fed.
Cir. 2011). “We may find an abuse of discretion on a
showing that the court made a clear error of judgment in
weighing relevant factors or exercised its discretion based
upon an error of law or clearly erroneous factual findings.”
Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363,
1379 (Fed. Cir. 2008) (internal quotation marks omitted).
A permanent injunction is an equitable remedy.
Weinberger v. Romero-Barcelo, 456 U.S. 305, 311 (1982).
“It ‘is not a remedy which issues as of course,’ or ‘to restrain
an act the injurious consequences of which are
merely trifling.’” Id. (citation omitted) (quoting Harrisonville
v. W.S. Dickey Clay Mfg. Co., 289 U.S. 334, 337–38
(1933) and Consol. Canal Co. v. Mesa Canal Co., 177 U.S.
296, 302 (1900)).

(...)

But an injunction in patent law must be justified like
any other: “the moving party must satisfy the court that
relief is needed.” United States v. W. T. Grant Co.,
345 U.S. 629, 633 (1953). The movant must prove that it
meets all four equitable factors. i4i Ltd. P’ship v. Microsoft
Corp., 598 F.3d 831, 861 (Fed. Cir. 2010). And it
must do so on the merits of its particular case. eBay,
547 U.S. at 391.




There was an issue that Everlight was not truly a competitor of
Nichia, and thus there was no "harm" forthcoming if there were no injunction:


We disagree, not because we question the facts as
Nichia presents them, but because the court heard these
arguments as the original finder of fact and concluded to
the contrary, carefully weighing both parties’ evidence.
The court found that Nichia is an LED chip manufacturer
as well as a packager, “while Everlight is solely an LED
packager.” Nichia, 2016 WL 310142, at *53. The court
also found that the two companies generally sell to different
parties: “Everlight generally sells to distributors
rather than directly to customers, as Nichia does.” Id.
Moreover, despite the parties’ stipulation that they competed
in the same market, J.A. 2112, ¶ 148, the court
found that Nichia failed to prove that this competition
was meaningful, Nichia, 2016 WL 310142, at *65. The
court explained that Everlight’s competition accounted for
“the proverbial ‘drop in the bucket,’” when compared to
Nichia’s total sales. Id. Nichia identified 516 sales opportunities,
with Everlight as a competitor in only 3. Id. In
light of these findings, the court noted that there was “a
very small area of possible competition,” but it concluded
that there was an “absence of actual competition.” Id

The court closed its market-competition analysis by
observing that the “justification for an injunction is remote
indeed.” Id.



Of interest, the CAFC did disagree with ED Texas on a point
about licensing:


Nichia further contests the court’s findings with respect
to Nichia’s licensing activities. Nichia argues that
the court wrongly found that its licensing activities precluded
a finding of irreparable harm. Nichia argues that
the court’s decision is contrary to settled law, as it applies
a categorical rule that licenses preclude irreparable harm.
To the extent the court adopted a categorical rule, we
agree with Nichia; such a rule would run afoul of our
precedent. We have explained, for example, that “[a]
plaintiff’s past willingness to license its patent is not
sufficient per se to establish lack of irreparable harm if a
new infringer were licensed.” Acumed LLC v. Stryker
Corp., 551 F.3d 1323, 1328 (Fed. Cir. 2008) (citing eBay,
547 U.S. at 393).
But to the extent that the court found that Nichia’s
prior licenses weighed against a finding of irreparable
harm, we countenance that approach. While evidence of
licensing activities cannot establish a lack of irreparable
harm per se, that evidence can carry weight in the irreparable-harm
inquiry. We have previously explained that
“[t]he fact of the grant of previous licenses, the identity of
the past licensees, the experience in the market since the
licenses were granted, and the identity of the new infringer
all may affect the district court’s discretionary decision
concerning whether a reasonable royalty from an infringer
constitutes damages adequate to compensate for the
infringement.” Id.




Of confusion about the "four factors" of eBay(ie, must all four factors be shown?)

**note the 2006 article by L. Ebert, which includes the text about the Weinberger case relied upon by the eBay court:


The Weinberger case does not enumerate a four factor test for consideration in granting a permanent injunction. In fact, the Weinberger case was not strictly about the grant of a permanent injunction because the ultimate merits were to be resolved in the permit application. The decision in eBay v. MercExchange about the presence of a four factor test for permanent injunctions may have unintended consequences. In ZEN INVESTMENTS, 2006 U.S. Dist. LEXIS 37171 (decided June 2, 2006), the court noted: "The Third Circuit has been unsettled n5 on whether a plaintiff must prove irreparable harm to receive a permanent injunction, as opposed to a preliminary injunction which always requires a showing of irreparable harm." The eBay decision squarely brings back "irreparable harm" into the permanent injunction calculus without giving much guidance on how to evaluate irreparable harm. The immediate impact will be more uncertainty.

Ironically, the cite to a non-existent four factor test by the eBay court resonates with certain questionable citation practices in the Weinberger case. For example, the appropriateness of citations of the Weinberger court to other cases which appear on page 312 has been questioned by legal academics. Thus, Douglas Laycock wrote of Weinberger in the Harvard Law Review in 1990 (103 Harv. L. Rev. 687):

The Court said it "has repeatedly held that the basis for injunctive relief in the federal courts has always been irreparable injury and the inadequacy of legal remedies." It then cited Rondeau v. Mosinee Paper Corp., a mootness case; Sampson v. Murray, a case about preliminary relief and deference to administrative agencies; Beacon Theatres, Inc. v. Westover, a jury trial case; and Hecht Co. v. Bowles,
a case that does not even mention the irreparable injury rule. Weinberger itself is about undue hardship and deference to the military. Each of these cases is cited in a different section of this Article; they have almost nothing in common except the phrase "irreparable injury." Hecht does not even have that; Hecht denied an injunction on the ground that it would be futile. The Court miscited it in Weinberger. Perhaps the law clerk assumed that any case that denied an injunction and mentioned discretion must have been an irreparable injury case.

Thus, the cases cited in the Weinberger decision, which was utilized to justify eBay v. MercExchange, don't really justify the proposition about "repeatedly held that the basis for injunctive relief is ...." Further, there is no four-facter list enumerated in the Weinberger case. Arguably, Weinberger v. Romero-Barcelo, 456 U.S. 305, 311 (1982) taught that an injunction will not "'restrain an act the injurious consequences of which are merely trifling'" (quoting Consolidated Canal Co. v. Mesa Canal Co., 177 U.S. 296, 302 (1900)), an issue quite distinct from that faced in eBay v. MercExchange.

Although the unanimous decision in eBay is characterized as a narrow decision reiterating previous law, it has the possibility of creating more uncertainty in the area of the application of the concept of "irreparable injury" to the calculus for permanent injunctions.

Other aspects of the eBay case were discussed in Los Angeles Times Gets Facts Wrong in Discussion about Supreme Court case, eBay v. MercExchange

Considering that the Thomas opinion cites the still valid 1908 Continental Paper case against the reasoning of the district court eBay opinion, the analysis of the four factors made by the Court of Appeals for the Federal Circuit in this case might still be valid, and a permanent injunction might still issue. So, ironically, for all the smoke, MercExchange may still get its permanent injunction and we may almost obtain "business as usual" in the use of permanent injunctions in patent law, even as greater uncertainty is injected into other areas.




link: http://EzineArticles.com/228415

**note the 2005 post on IPBiz


Which is the first post-eBay district court injunction case?

Mural of Michelle Obama by Chris Devins in Chicago draws plagiarism charge from Gelila Mesfin

There seems to be a mural in Chicago that was based on something from Pinterest, with the mural done without crediting the original source.

The quotation below (from cw33) suggests that credit, rather than money, may be the primary driver in this dispute.

From :


Devins says he wasn't aware of the art student's work until someone mentioned it to him. Devins also says he was inspired when he saw a picture on Pinterest -- a picture that just so happened to be that of Mesfin's work.

Coincidence or not, Mesfin responded to the mural on Instagram:

"How can you just steal someone's artwork... Someone's hard work and claim it like it's yours. It’s one thing to share or even profit from someone's work but to claim it as yours is just wrong!"



link: http://cw33.com/2017/04/27/plagiarism-or-coincidence-artists-fight-over-chicago-mural-of-michelle-obama/

Madison Place during the Civil War

The left stair section of the current Court of Claims building is "where" the entrance to the home of Secretary of State Seward was located in 1865. On April 14, 1865, Louis Powell, aka Lewis Payne, attempted to assassinate Seward, and severely disfigured Seward's face. The house, previously known as the “Club-House,” was the vicinity wherein Dan Sickles (later the commanding general of III Corps at Gettysburg) murdered his wife’s lover, Philip Barton Key, and was acquitted by use of the first successful use of the temporary insanity defense, with the defense done by Edwin Stanton, later Secretary of War. Stanton was the lead lawyer in a reaper patent case, the one time Abraham Lincoln got close to a patent litigation.

On-line paraphrasing software and "word salads"

In the short blip about "plagiarism" by then-Judge Gorsuch, one issue was that the
Judge cited fundamental references, rather than later references which cited
the fundamental references.

A more recent post on the problem of on-line paraphrasing tools briefly touched
on the issue of citing the older works:


Some other clues [that work was paraphrased]: A paper includes unusual strings of works — “word salads” — where the phrases don’t make sense; or a reliance on only older references, without anything related to more current thinking.

…it may be perfectly acceptable and expected to have some old references in some papers referring to seminal works, or when updating concepts or historical retrospectives. However if there is a reliance on older publications without any reference to current thinking or research (particularly where the references are not highly cited/regarded) it may be worth doing a little more digging.

To illustrate, we put the above quote into one of the many paraphrasing tools we found online. Here’s how it would read:

it might be splendidly worthy and anticipated that would have some old references in a few papers alluding to original works, or when refreshing ideas or authentic reviews. Nonetheless if there is a dependence on more seasoned distributions with no reference to momentum thinking or research (especially where the references are not exceedingly refered to/respected) it might be worth doing somewhat more burrowing.



link:
Retraction Watch
Tracking retractions as a window into the scientific process
A troubling new way to evade plagiarism detection software. (And how to tell if it’s been used.)

See also IPBiz post
http://ipbiz.blogspot.com/2017/04/the-charge-of-plagiarism-against.html

Duke University v. Biomarin. Duke saves two claims on appeal.

In Duke University v. Biomarin (2016-1106), one has a pharma company bringing an
IPR against a university, and the university appealing an unfavorable result to the CAFC.

Duke was able to save two claims:


Duke University (“Duke”) appeals from the decision of
the U.S. Patent and Trademark Office (“PTO”) Patent
Trial and Appeal Board (“Board”) in an inter partes review
(“IPR”) holding claims 1–9, 11, 12, 15, and 18–21 of U.S.
Patent 7,056,712 (the “’712 patent”) unpatentable. See
BioMarin Pharm. Inc. v. Duke Univ., No. IPR2013-00535,
2015 WL 1009196 (P.T.A.B. Feb. 23, 2015) (“Board Decision”),
aff’d on reh’g, 2015 WL 4467381 (P.T.A.B. July 14,
2015) (“Rehearing Decision”). Because the Board erred in
holding claims 9 and 19 unpatentable, but did not otherwise
err, we affirm in part, reverse in part, vacate in part,
and remand.



Of claim 9:


We begin with Duke’s argument relating to the proper
construction of the term “precursor” in claim 9. In an
IPR, a patent claim is given “its broadest reasonable
construction in light of the specification of the patent in
which it appears.” Cuozzo Speed Techs., LLC v. Lee, 136
S. Ct. 2131, 2142 (2016) (quoting 37 C.F.R. § 42.100(b)).
“[W]e review the Board’s ultimate claim constructions de
novo and its underlying factual determinations involving
extrinsic evidence for substantial evidence.” Microsoft
Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1297 (Fed. Cir.
2015) (citing Teva Pharm. USA Inc. v. Sandoz, Inc., 135 S.
Ct. 831, 841–42 (2015)). Here, because the intrinsic
record alone determines the proper construction of “precursor,”
we review the Board’s construction de novo. See
Shire Dev., LLC v. Watson Pharm., Inc., 787 F.3d 1359,
1364, 1368 (Fed. Cir. 2015) (citing Teva, 135 S. Ct. at
840–42).

(...)

However, our agreement with BioMarin as to what
the Board held is not the same as agreeing with the
Board’s holding. On this point, we disagree with the
Board’s construction and agree with Duke that the proper
construction of “precursor” in claim 9 is “exclusively a
precursor of recombinant hGAA that has been produced
in CHO cell cultures.” Claim 9 requires that “the [hGAA]
is a precursor” and refers to claim 1 for the antecedent
basis of “the [hGAA].” ’712 patent col. 13 ll. 9–12 (emphases
added). That sentence structure makes clear that the
“is a precursor” phrase limits the form of hGAA to a
precursor form. The claim language and structure thus
support the conclusion that “the [hGAA]” in claim 9 is
exclusively a precursor of hGAA.

(...)

Applying the correct construction, we agree with Duke
that van Bree does not disclose a “precursor.” The Board
did not find that van Bree discloses administering exclusively
a precursor of rhGAA produced in CHO cell cultures.
See Board Decision, 2015 WL 1009196, at *12.
And BioMarin does not argue on appeal that van Bree’s
disclosure teaches the “precursor” limitation of claim 9
under the correct construction. Thus, we reverse the
Board’s finding that claim 9 was anticipated.


Of claim 19:


Duke argues that the Board’s claim 19 obviousness
determination is legally deficient and the underlying factfinding
is not supported by substantial evidence because
it rests on cursory and conclusory expert testimony.
(...)
We agree with Duke that the Board erred in concluding
that claim 19 was unpatentable as obvious. Substantial
evidence does not support the Board’s finding that
“the prophylactic administration of an immunosuppressant
would have been a predictable variation of the use of
immunosuppressant disclosed in Brady.” Id. at *8. It is
undisputed that the Board correctly found that “Brady
does not disclose administering immunosuppressant prior
to any and all administration of hGAA, as required by
claim 19.” Rehearing Decision, 2015 WL 4467381, at *4.
The expert testimony relied on by the Board to bridge the
gap between the disclosure in Brady and claim 19 falls
short of what would have rendered the subject matter of
claim 9 obvious.
(...)
Thus, the
evidence of record does not establish the conditions precedent
(a high incidence of patients with high antibody
titers to the enzyme) to the prophylactic administration of
immunosuppressants according to the expert’s testimony.
Such conclusory expert testimony cannot support an
obviousness conclusion. See In re Magnum Oil Tools, 829
F.3d at 1380 (“To satisfy its burden of proving obviousness,
a petitioner cannot employ mere conclusory statements.
The petitioner must instead articulate specific
reasoning, based on evidence of record, to support the
legal conclusion of obviousness.”). The evidence thus fails
to render claim 19 obvious.



Of the presumption of nexus



Notably, Duke’s objections to the Board’s treatment
of its evidence of objective indicia of non-obviousness—
including its failure to apply a presumption of nexus—
appear well taken.


Some legal points:


Expert testimony was not necessary to support the
Board’s anticipation determination. Here, the disclosures
of van Bree alone were sufficiently clear and on point to
constitute substantial evidence to support the Board’s
anticipation findings. Thus, the Board “could permissibly
‘rely on its own reading of [van Bree]—supported by the
Petition’s observations about it’—to find that the [limitations]
were disclosed.” In re NuVasive, Inc., 841 F.3d 966,
973 (Fed. Cir. 2016) (quoting Belden Inc. v. Berk-Tek LLC,
805 F.3d 1064, 1074 (Fed. Cir. 2015)).

Duke also argues that the Board “acted outside its
statutory authority in instituting an IPR and in its Final
Decision by adopting anticipation theories that BioMarin
never raised.” Appellant’s Br. 46. We reject this argument
on its merits insofar as it challenges the Board’s
final decision.




Footnote 1 of the Duke case:


We note that Duke has not raised an enablement
challenge to van Bree and that, in any event, proof of
efficacy or an actual reduction to practice using CHO cell
cultures is not required for a reference to be an anticipation
of the challenged method of treatment claims. In re
Gleave, 560 F.3d at 1334; Rasmusson v. SmithKline
Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005)
(explaining “proof of efficacy is not required in order for a
reference to be enabled for purposes of anticipation”).

New study suggests role of protein Rab32 in multiple sclerosis

Of new work by Professor Paul Eggleton and colleagues in multiple sclerosis, Science Daily reported on 24 April 2017:


The joint Exeter-Alberta research team was the first to combine clinical and laboratory experiments to explain how mitochondria becomes defective in people with MS. Using human brain tissue samples , they found that a protein called Rab32 is present in large quantities in the brains of people with MS, but is virtually absent in healthy brain cells.

Where Rab32 is present, the team discovered that a part of the cell that stores calcium (endoplasmic reticulum or ER) gets too close to the mitochondria. The resulting miscommunication with the calcium supply triggers the mitochondria to misbehave, ultimately causing toxicity for brain cells people with MS.



From MedicalNewsToday:


In their new investigation, the researchers study a protein called Rab32, which is known to be involved in certain mitochondrial processes.

They found that levels of Rab32 are much higher in the brains of people with MS and hardly detectable in brains of people without the disease.

They also discovered that the presence of Rab32 coincides with disruption to a communication system that causes mitochondria to malfunction, causing toxic effects in the brain cells of people with MS.



link: http://www.medicalnewstoday.com/articles/317077.php


The journal citation:

Yohannes Haile, Xiaodan Deng, Carolina Ortiz-Sandoval, Nasser Tahbaz, Aleksandra Janowicz, Jian-Qiang Lu, Bradley J. Kerr, Nicholas J. Gutowski, Janet E. Holley, Paul Eggleton, Fabrizio Giuliani, Thomas Simmen. Rab32 connects ER stress to mitochondrial defects in multiple sclerosis. Journal of Neuroinflammation, 2017; 14 (1) DOI: 10.1186/s12974-016-0788-z


Note also the 2012 paper:

Expression profiling of Rab GTPases reveals the involvement of Rab20 and Rab32 in acute brain inflammation in mice
Neuroscience Letters 527(2):110-4 · August 2012

Kanzius and "burning water": ten years later and no energy breakthrough

Certain "inventions" garner much publicity, such as the work of John Kanzius on treating cancer and "burning salt water", which made its way to "60 Minutes" in 2008 after much discussion in 2007. BUT "where we are now" is not exactly the place envisioned by "60 Minutes." A brief review of some events since 2007 is given and the key patent application, after many years of prosecution, was allowed to go abandoned in 2014.

Almost 10 years ago, in late 2007, Popular Science discussed the "burning water" claim of John Kanzius:


Last winter, inventor John Kanzius was already attempting one seemingly impossible feat-building a machine to cure cancer with radio waves-when his device inadvertently succeeded in another: He made saltwater catch fire. TV footage of his bizarre discovery (check out the video below) has been burning up the blogosphere ever since, drawing crackpots and Ph.D.s alike into a raging debate. Can water burn? And if so, what good can come of it?

Some people gush over the invention's potential for desalinization or cheap energy. Briny seawater, after all, sloshes over most of the planet's surface, and harnessing its heat energy could power all sorts of things. Skeptics say Kanzius's radio generator is sucking up far more energy than it's creating, making it a carnival trick at best.



link: Turning Water into Fuel

There were many issues with the "60 Minutes" piece, which were raised at the time, but largely ignored.
For example
Stahl's "60 Minutes" piece on Kanzius: patents and conflict matters?



One relevant patent application of Kanzius is US 20090294300, titled
Rf systems and methods for processing salt water with abstract:


Systems and methods for processing salt water and/or solutions containing salt water with RF energy. Exemplary systems and methods may use RF energy to combust salt water, to produce hydrogen from salt water or solutions containing salt water, to volatilize a secondary fuel present in solutions containing salt water, to produce and combust hydrogen obtained from salt water or solutions containing salt water, to volatilize and combust secondary fuel sources present in solutions containing salt water, to desalinate seawater, and/or to carry out the electrolysis of water are presented. An exemplary system may comprise a reservoir for containing a salt water solution or salt water mixture; a reaction chamber having an inlet; a feed line operatively connecting the reservoir to the inlet of the reaction chamber; an RF transmitter having an RF generator in circuit communication with a transmission head, the RF generator capable of generating an RF signal absorbable by the salt water solution or the salt water mixture having a frequency for transmission via the transmission head; and an RF receiver; wherein the reaction chamber is positioned such that some of the salt water solution or salt water mixture is positioned between the RF transmission head and the RF receiver.


There is a lengthy file history for US 20090294300 ( 12/398,646. Earliest provisional 60/865,530 11-13-2006 ), with a non-final rejection on 6 January 2014, and an abandonment of the case on 15 August 2014. There were rejections for indefiniteness and for obviousness. [In passing, as one irony compared to The Medicines/Angiomax case, the examiner cites to In re Van Geuns, for the proposition that limitations from the specification are not read into claims, which is exactly what did happen in The Medicines case.)

Also, as to the patent realm, note the 2008 IPBiz post
Some Kanzius patent applications , concerning US 20070250139.

Of prior art, note the IPBiz post "Burning water, before Kanzius," which includes discussion of United States Patent 4,265,721
Hackmyer May 5, 1981.



From the 2008 IPBiz post
Kanzius, and burning water, again , about a question put to Kanzius:


Q What is happening with research at Pennsylvania State University about using the device to "burn" saltwater? There has been debate on the subject that it takes more energy to heat the saltwater than the chemical reaction releases.

A Everyone says it's all about "energy in, energy out" but (Rustum Roy, a Penn State professor who is leading saltwater-to-energy research on the device) said it costs $1.35 to make a gallon of ethanol and nobody complains about that and the fact it has more carbon releases in it than gasoline. Everyone says this is green. This is the way to go. (Roy) said, "Wouldn't you rather have something that gives off pure drinking water as a by-product and may be nearly as efficient as ethanol?"

If you got the idea that Kanzius didn't answer the question, you are right. It would take more energy (which, in the US, comes mostly from fossil fuels) to make the electricity to make the hydrogen than one gets out of the hydrogen. That's a net negative.



Also


Mass confusion on burning water?

CAFC reverses D. Oregon in Skedco case

From the decision:



Skedco, Inc. (“Skedco”) is the exclusive licensee of U.S.
Patent No. 8,342,852 (“the ’852 patent”). The ’852 patent
is directed to a system for simulating trauma with lifelike
mannequins. The system is used in the training of medical
personnel. ’852 patent, 1:19–24, 3:29–41. Skedco sued
Strategic Operations, Inc. (“StOps”) in the United States
District Court for the District of Oregon for infringement
of claims 18, 19, and 20 of the patent. On December 8,
2015, the district court granted summary judgment of
noninfringement, both literal and under the doctrine of
equivalents, and entered judgment dismissing Skedco’s
complaint. See Skedco, Inc. v. Strategic Operations, Inc.,
154 F. Supp. 3d 1099 (D. Or. 2015). Skedco now appeals
from that judgment. We vacate and remand.


The issues:


On appeal, Skedco focuses on the district court’s construction
of the two claim limitations discussed above. As
far as the first limitation is concerned, Skedco urges that
the district court erred when it required the valve and
pump in the BPS to be physically separate. As to the
second limitation, Skedco disagrees with the district
court’s construction of “connected to” as “joined, united or
linked to.” In Skedco’s view, “connected to” should be
construed to mean “interacts directly or indirectly with.”
In the alternative, Skedco contends that the district court
erred when it required “direct,” “independent,” physical,”
and “separately controlling” connections between the
controller and the pump and valve structures in the BPS.
For these reasons, Skedco argues, the district court erred
in granting summary judgment of no literal infringement
by StOps’s BPS.



Skedco quickly won on the first point:


The district court construed “at least one valve in fluid
communication with said pump” to require the pump
and valve to be physically separate structures. Skedco,
154 F. Supp. 3d at 1111–12. We hold that this was error.
(...)
In this case, nothing in the claims requires the pump
and valve to be physically separated. The claimed valve
need only be “in fluid communication with” the claimed
pump. ’852 patent, 14:9. Nothing prevents a pump from
being “in fluid communication with” an internal valve.
See Powell v. Home Depot U.S.A., Inc., 663 F.3d 1221,
1232 (Fed. Cir. 2011) (declining to construe “in fluid
communication” as requiring separate structures). In
fact, the claims expressly contemplate this possibility.
See Philips, 415 F.3d at 1314. Independent claim 1
recites a “pump in fluid communication with [a] reservoir”
wherein “said pump is in a cavity of said reservoir.” ’852
patent, 11:46–47 (emphasis added).


Of interest from the CAFC:


StOps maintains the separateness of the pump and
valve by pointing to various figures of the ’852 patent and
concluding that they “would be rendered nonsensical” if
the valve were integral to the pump. Appellee Response
Br. 20–21. This approach gets our precedent backwards.
“[I]t is the claims, not the written description, which
define the scope of the patent right.” Laitram Corp v.
NEC Corp., 163 F.3d 1342, 1347 (Fed. Cir. 1998). Patents
do not need to include drawings of particular embodiments
in order to claim them. See CCS Fitness, Inc. v.
Brunswick Corp., 288 F.3d 1359, 1367 (Fed. Cir. 2002).
For this reason, a claim is not limited to inventions looking
like those in the drawings. MBO Labs., Inc. v. Becton,
Dickinson & Co., 474 F.3d 1323, 1333 (Fed. Cir. 2007).
This guidance is especially apt here because the patent
refers to the drawings to which StOps points as “exemplary
embodiment[s].” ’852 patent, 2:42–3:15.


And, as to claim 18:


We hold that it was
error for the district court to have included some of these
additional limitations into claim 18.



Bottom Line:


In sum, we hold that the district court erred in its
construction of the limitation “at least one valve in fluid
connection with said pump” and the limitation “a controller
connected to said pump and said at least one valve.”
We therefore vacate the district court’s grant of summary
judgment of no literal infringement of claims 18, 19, and
20 and remand the case to the court to conduct analysis
based upon the claim constructions articulated in this
opinion. In so doing, we express no views on the issue of
literal infringement.

PTAB partially reversed in AUTOLIV case

As to PTAB error:


Further, Ms. Balavich agreed with Autoliv’s interpretation
of Paragraph 71, and no evidence suggests an
alternative reading of the passage. Because Tajima’s
fixed vents do not “provide consistent venting” that is “not
restricted by an occupant’s position,” the Board erred in
finding that Tajima discloses the claimed “fixed vents”
limitation.

(...)

We disagree, however, with the Board’s conclusion
that Tajima discloses the claimed diffuser. Tajima’s
diffuser redirects “the gas flow to the left and right sides
of the airbag.” J.A. 35. The side vents, however, are
“separated from the vicinity of [the diffuser] in order to
prevent the destruction thereof after the complete expansion
of the airbag. . . .” J.A. 670 at [0071]. This suggests
that Tajima’s diffuser does not direct gas to rapidly exit
the side vents, as required by the ’653 patent. Rather,
Tajima focuses on redistributing gas to ensure smooth
deployment of the airbag. J.A. 667 at [0035]; J.A. 669 at
[0070]. Thus, the record does not contain substantial
evidence showing that Tajima’s diffuser redirects gas to
rapidly exit the side vents, or that a person of ordinary
skill in the art would have altered Tajima’s diffuser to
obtain this claimed result. Therefore, the Board erred in
finding the “diffuser” limitation obvious.

PTAB IPR decision in Synopsys v. ATopTech reversed by CAFC

The decision of PTAB was reversed in the Synopsys case; Synopsys wins :



The present appeal arises from an inter partes review
(“IPR”) involving ATopTech, Inc. (“ATopTech”) and Synopsys,
Inc. (“Synopsys”). ATopTech petitioned for IPR of
independent claims 1 and 32 of Synopsys’ U.S. Patent No.
6,567,967 (the “’967 patent”). The Patent Trial and Appeal
Board (the “Board”) instituted IPR and held that
claim 1 would have been obvious in light of the combination
of Carol A. Fields, Creating Hierarchy in HDL-Based
High Density FGPA [sic] Design, Euro-DAC ’95, 594–99
(Sep. 18–22, 1995) (“Fields”) and Hsiao-Pin Su, et al.,
Performance-Driven Soft-Macro Clustering and Placement
by Preserving HDL Design Hierarchy, Proceedings, 1998
International Symposium on Physical Design: ISPD-98,
12–17 (April 8, 1998) (“Su”).1 The Board also found that
Su anticipated claim 32. Synopsys appeals to our court.
Because the Board’s decision is not supported by substantial
evidence, we reverse.


As to the Su reference:


The cited disclosures from Su do not provide substantial
evidence to support the Board’s determination that Su
teaches or suggests elimination of a level of hierarchy
above the atomic blocks.



An inconsistency between PTAB and the appellee ATopTech was noted:



Every reference in Su to improved
performance attributes that improved performance
to its placement of soft blocks. We fail to see how a disclosure
which repeatedly touts the value of optimizing the
placement of soft blocks expressly discloses the claimed
“optimal placement” of hard blocks.

ATopTech argues that because Su teaches a “performance-driven”
method, the commercial floorplanner used
to place hard blocks must place those blocks in their
optimal location. This argument is inconsistent with the
Board’s findings. The Board found that although Su
expressly anticipated claim 32, it did not inherently
anticipate the claim. J.A. 27 n.2. This distinction is fatal
to ATopTech’s argument. A reference inherently anticipates
a limitation only when it “must necessarily include
the unstated limitation.” King Pharm., Inc. v. Eon Labs,
Inc., 616 F.3d 1267, 1274 (Fed. Cir. 2010) (emphasis in
original).

Was the CRISPR interference outcome foreseeable?

A comment about the CRISPR patent interference battle appeared on Patent Docs on 20 April 2017:




The decisive lack of "Reasonable Expectation of Success" finding whereby inventive skill would have been required to transition the disclosed Doudna CRISPR technology platform from prokaryotes (e.g. bacteria) to eukaryotes (e.g. mammalian cells) seems doubtful when considering the course of the scientific literature that parallels the numerous patent filings.

The technical aspects of Doudna's CRISPR discoveries are embodied in a Science article (Jinek et al) e-published on June 28, 2012.

The BROAD/MIT group filed their "eukaryotic" CRISPR application on December 12, 2012. The counterpart scientific paper was published on January 3, 2013 (Cong et al).

To my knowledge, Science requires a peer review process prior to publication, usually requiring 1-2 months.

Consequently, the incredibly quick turnaround from Jinek to Cong, where Zhang managed to develop and execute extensive lab protocols that produced new, verifiable results in just a matter of weeks suggests that Doudna's findings indeed provided Zhang with a RES that the eukaryotic system would be amenable in supporting Doudna's CRISPR platform, as Doudna suggests in the Jinek article.

This, especially since Zhang merely applied known technologies (NLS sequences, used since the 1980s) in order to guide the CRISPR system into the eukaryotic cell compartments.

Accordingly, it is apparent that the PTAB might have erred in their findings by being dismissive of the science itself.



Link: http://www.patentdocs.org/2017/04/university-of-californiaberkeley-appeals-adverse-crispr-decision-by-ptab.html

More than two years earlier, in a post in March 2015, IPBiz noted that the USPTO had passed the patent application of Zhang et al. to allowance over Jinek, which made the outcome of the interference foreseeable [i.e., Zhang work NOT obvious over that of Jinek and Doudna):


** US 8,945,839 issued on February 3, 2015. A "Track I" request had been made on 18 April 2014. A final rejection was issued on 18 Nov. 2014, with claims 1-28 rejected as anticipated over Jinek, WO'772 (later identified as Doudna). There was an issue of whether or not the priority documents to WO 2013/176772 supported the later disclosure. In this, there was an issue that the patent applicant had presented only arguments of counsel, with the examiner citing to In re Huang, 100 F.3d 136, 139 (CAFC 1996 ) and In re De Blauwe, 736 F.2d 699, 705 (CAFC 1984 ). Applicant brought up arguments made to the EPO about a Jinek journal publication, which were not of interest to the USPTO.
In a response filed 1 Dec. 2014, applicant was especially harsh to the Doudna application: "Doudna is nothing more than a mere 'second comer' and had no CRISPR-Cas invention prior to Feng Zhang."


See


CRISPR is high profile in science, patents; competitor labeled a mere second comer

Also, in an evaluation of patentability of Zhang's claims, the full scope of disclosure of the Jinek/Doudna reference was considered, but in an interference one compares only the claims. It was unlikely that the PTO would have altered its position of Doudna v. Zhang in the later (interference) proceeding. Whether this was the correct scientific outcome can be debated.

UPDATE on 28 April 2017:

For completeness, the 2012 Jinek paper was discussed in the interference proceedings related to US 8,945,839. At page 14 of the interference decision, PTAB notes that Jinek said in 2013 that it was not known whether such bacterial system would function in eukaryotic cells. Page 15 includes similar expressions of doubt made by Doudna after Jinek 2012. Page 17 illustrates a strategic error by the UC lawyers, who argued that Jinek and Doudna were not workers of ordinary skill, which PTAB turned on its head in observing that if extraordinary workers manifested doubt, there would be LESS expectation of success for those of ORDINARY skill. The immediacy of later success (argued by Korben) is discussed on page 23, and analysis is made in the next 23 pages. Not clear that PTAB was being dismissive of the science.

As to the 2012 Jinek work, recall also the Zhang work was already patented over Jinek. See for example the 2015 post on IPBiz:
CRISPR is high profile in science, patents; competitor labeled a mere second comer


AND

As to the text -- that CRISPR basically uses the same process for viruses and eukaryotic cells, --, CRISPR-Cas systems protect prokaryotes FROM viruses. The legal determination of "no interference-in-fact" stemmed from the conclusion that Zhang's claims were patentable over Doudna's because one of ordinary skill did not have a reasonable expectation of success in going from Doudna's prokaryotes to Zhang's eukaryotes. Supporting facts arose from statements made by Jinek and Doudna expressing doubt about the transition. As to the future of UC's patent claims, there may be some issues as to enablement of the full scope of the claims, especially in light of BOTH the issuance of the Zhang patent AND the interference result.

Mixed result in IPR v. ZTE

Of interest in the ZTE case:


Our
review under the APA is subject to a harmless-error rule
by virtue of the directive of 5 U.S.C. § 706 that “due
account shall be taken of the rule of prejudicial error.”
See Shinseki v. Sanders, 556 U.S. 396, 406, 409 (2009)
(explaining that § 706 requires the party challenging an
agency decision on appeal to demonstrate the harmfulness
of the asserted error). Here, we need not decide
whether ZTE’s position on reply was a shift or a clarification
because IPRL has not shown that it suffered harm
from the process it challenges.



As to claim 8:



The Board then seemed to hold that claim 8 would
have been obvious because “Jawanda explicitly states that
the wireless data connections could be provided by a code
division multiple access (CDMA) network.” Id. at *18
(quoting Pet’r’s Reply 13) (internal quotation marks
omitted). The logic of the Board’s analysis is wanting.
As noted, the Board found earlier that Jawanda did
not disclose “maintain[ing] a communication session” at
all: the Board relied wholly on the GPRS standard for
that limitation. Moreover, the Board cited no prior-art
reference that discloses that CDMA networks at the time
of the invention could “maintain a communication session”
according to the claims. Accordingly, the Board
must have held that it would have been obvious to combine
the PDP Context feature of the GPRS standard that
enables the subscriber unit to “maintain a communication
session” with a CDMA network. We do not see the support
for that inference.

(...)

While that testimony may
establish that, at some point, there was a reason to combine
the PDP Context feature with CDMA protocols, it
does not provide that reason or show why the references
cited or the knowledge of one of skill in the art at the time
of the invention would motivate a skilled artisan to alter
the standards with a reasonable expectation of success.
Nor does Dr. Stark’s testimony establish that, at the time
of the invention, the CDMA standard already included the
“maintain a communication session” limitation.

Paice loses appeal at CAFC of IPR decision in Ford case involving hybrid vehicles

Paice loses the appeal to the CAFC of IPR2014-
00570.


See
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1411.Opinion.4-19-2017.1.PDF

CAFC in Fairchild v. Power Integrations: Put simply, “[i]f a defendant brought an invalidity challenge in a district court litigation and was unsuccessful, it is not permitted to bring the same challenge in an inter partes reexamination.”

The outcome was "Fairchild wins":


Fairchild (Taiwan) Corporation moves the court to
remand this case to the Patent Trial and Appeal Board
with instructions to vacate certain aspects of its final
decision in the underlying inter partes reexamination and
issue a reexamination certificate. Power Integrations,
Inc. opposes the motion. We agree with Fairchild and
grant the motion.



The issue related to concurrent proceedings before PTAB and the court system:


In June 2012, Power Integrations requested inter
partes reexamination of claims 1, 2, 5–7, 11, 12, 15, 17–19,
22, 32, 34, and 52–66 of the ’972 patent. The examiner
rejected all of the claims in the reexamination, including
claims 6, 7, 18, and 19, finding those claims unpatentable
under § 103(a) in view of TEA1401T and Balakrishnan.
In December 2015, the Board issued a decision affirming
the examiner’s rejection of the claims. After the Board
denied Fairchild’s request for rehearing, Fairchild appealed
to this court in October 2016. Fairchild brought
this motion to vacate and remand following the issuance
of this court’s mandate in Power Integrations.



From text within Fairchild:


Put simply, “[i]f a defendant
brought an invalidity challenge in a district court litigation
and was unsuccessful, it is not permitted to bring the
same challenge in an inter partes reexamination.” Function
Media, L.L.C. v. Kappos, 508 F. App’x 953, 955–56
(Fed. Cir. 2013) (holding that there was no basis for
continuing an appeal in light of § 317(b)).


We have held that this restriction applies when “all
appeals have terminated.” Bettcher Indus., Inc. v. Bunzl
USA, Inc., 661 F.3d 629, 646 (Fed. Cir. 2011). That is
precisely the situation here. The district court entered
judgment against Power Integrations, holding that it
failed to prove claims 6, 7, 18, and 19 were obvious over
Majid and Balakrishnan. This court affirmed the holding,
and the time to petition for a writ of certiorari has passed.
Moreover, Power Integrations does not dispute that these
obviousness grounds could have been raised in the civil
action in which it failed to meet its burden.
While it is true that in Power Integrations this court
vacated and remanded for additional proceedings, we
cannot agree with Power Integrations that this renders
the decision not “final” for [35 USC] § 317(b) purposes. Critically,
those proceedings are unrelated to the ’972 patent. By its
terms, § 317(b) is concerned with a final decision “that the
party has not sustained its burden of proving the invalidity
of any patent claim.”

Hypotheticals on the upcoming CRISPR patent wars

The discussion at Patent Docs relating to the reverse doctrine of equivalents pertained to the CRISPR dispute between UC/Berkeley and the Broad. How would a party, practicing CRISPR on eukaryotes, defend against a (hypothetical) patent infringement assertion by UC/Berkeley of a (hypothetical) US patent claim?

An issue would be enablement of a Berkeley claim as to eukaryotes.

Recall the text of Judge Linn in Ariad ( with whom RADER, Circuit Judge, joins, dissenting-in-part and concurring-in-part. ):


The fear that even original claims might "claim[] the invention by what it does rather than what it is," Lilly's Br. 35, is unfounded because all claims must satisfy enablement and other requirements for patentability. The majority agrees that "many original claims will satisfy the written description requirement," but expresses concern that applicants may use "functional language to define the boundaries of a claimed genus," without disclosing "species sufficient to support a claim." Maj. Op. at 19. I agree that such claims should be invalid--but enablement polices those claims effectively. Any claim that uses purely functional language, or covers a broad genus without sufficient supporting examples, will not be enabled. E.g., In re Vaeck, 947 F.2d 488, 495-96 (Fed. Cir. 1991) (affirming enablement rejection of genus claims).

Lilly and several amici caution that the written description doctrine protects the public by requiring patentees to provide specific notice of the scope of their inventions. See, e.g., Br. of Amicus Medtronic, Inc. 11-12. This concern is also misplaced. Generally, under 35 U.S.C. § 122(b), patent applications [**105] publish eighteen months "from the earliest filing date for which a benefit is sought." Therefore, the public receives notice of original claims within a specified time. See Br. of Amicus Monsanto Co. 8 ("Regardless of its breadth, the language of an original claim puts skilled artisans on notice that the inventor is claiming such subject matter as the inventor's own invention."). Even if the application does not publish before the patent issues, the original claims remain part of the public prosecution history and notify the public of the invention's scope.

The government submitted an amicus brief in which it asserted that the written description doctrine is "necessary to permit USPTO to perform its basic examination function" and claimed that the Patent Office applies § 112, paragraph 1 to over "400,000 patent applications each year." Br. of Amicus United States 19-20. However, at oral argument the government could not cite the number of applications that the PTO annually rejects on written description grounds and cannot reject on another basis. See Oral Arg. at 22:42-24:50. [*1372] The government also agreed that "enablement is available to address a large number of these problems." Id. at [**106] 28:01-32. Indeed, a study released after argument that reviewed over 2800 appeals to the Board of Patent Appeals and Interferences ("BPAI") during 2009 found that only 4.3% of those cases decided written description issues, and that none of those outcomes would change if the PTO could continue to issue new matter rejections under 35 U.S.C. § 132. Dennis D. Crouch, An Empirical Study of the Role of the Written Description Requirement in Patent Prosecution 2 (Univ. of Mo. Sch. of Law Legal Studies Research Paper No. 2010-06, 2010), available at http://ssrn.com/abstract=1554949. The study concludes that, "in the context of patent applications appealed to the BPAI, the impact of the separate written description requirement is negligible apart from its role in policing the addition of new matter." Id. at 3. While this research only addressed a small sample of applications and did not consider written description rejections that applicants overcome or do not appeal, these results and the government's lack of empirical evidence undermine the government's hypothesis that our patent examination system would grind to a halt if written description no longer applies to originally filed claims. [**107] The Patent Office survived well enough before 1997, when it was understood that written description was a basis for rejecting broadening amendments to claims or specifications, not [***1188] original claims. See Rasmussen, 650 F.2d at 1214.

The court granted the petition for rehearing in this case to address whether § 112, paragraph 1 contains a written description requirement separate from an enablement requirement and, if so, the scope and purpose of such a requirement. In affirming such requirement, the majority leaves unanswered once again the critical question first presented to the panel of whether the asserted claims of the '516 patent meet the enablement requirement. In my view, the question before the en banc court should have been answered in the negative and the appeal returned to the panel for resolution of the enablement question and Lilly's remaining invalidity and noninfringement defenses. I concur, however, in the majority's reinstatement of the panel's affirmance of no inequitable conduct. For these reasons, I respectfully dissent from Part I of the majority opinion, concur in the ruling of no inequitable conduct, and take no position on the merits of Ariad's compliance with 35 U.S.C. § 112, [**108] paragraph 1.




Recall also Johns Hopkins v. Cellpro, 152 F.3d 1342


CellPro argues that the claims of the '204 patent, which both parties agree are drawn to the genus of antibodies which bind to the claimed antigen, are not enabled as required by 35 U.S.C. § 112, P 1, and that the district court erred in granting summary judgment to the contrary. CellPro contends that the patent discloses only the method of producing the anti-My-10 antibody and is therefore insufficient to enable one of ordinary skill in the art to make and use the broader genus of claimed antibodies. See, e.g., Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365, 42 U.S.P.Q.2D (BNA) 1001, 1004 (Fed. Cir. 1997) HN13Go to this Headnote in the case.("To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.") (citation and quotation omitted). In support, CellPro points to evidence that it believes conclusively shows that one of ordinary skill following the techniques disclosed in the patent could produce other antibodies only after undue experimentation, and contends that this evidence should have precluded summary judgment.

(...)

When ruling on Hopkins' motion for summary judgment of enablement, the district court was obliged to have viewed the evidence in the light most favorable to the nonmoving party, in this case CellPro, and to have resolved any evidentiary doubts in CellPro's favor. See C.R. Bard, Inc. v. Advanced Cardiovascular Sys., Inc., 911 F.2d 670, 672, 15 U.S.P.Q.2D (BNA) 1540, 1542 (Fed. Cir. 1990). Moreover, the court must have "viewed the evidence presented through the prism of the substantive evidentiary burden" that would inhere at trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 254, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986). This burden rested upon CellPro, who had to prove by clear and convincing evidence facts establishing a lack of enablement. See Morton Int'l Co. v. Cardinal Chem. Co., 5 F.3d 1464, 1469, 28 U.S.P.Q.2D (BNA) 1190, 1194 (Fed. Cir. 1993); 35 U.S.C. § 282 (1994). However, CellPro's evidence must have done more than simply raise some doubt regarding enablement: HN15Go to this Headnote in the case."If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted." Anderson, 477 U.S. at 249-50 (citations omitted). Instead, CellPro's evidence must have shown that a material factual dispute existed, i.e., [**49] a dispute upon which a reasonable jury could have resolved enablement in CellPro's favor after a review of the entire record. See Sweats Fashions, Inc. v. Pannill Knitting Co., 833 F.2d 1560, 1562, 4 U.S.P.Q.2D (BNA) 1793, 1795 (Fed. Cir. 1987).

Our review of the entire record leads to the conclusion that CellPro failed to raise a genuine issue of material fact concerning enablement, [p. 1360] and therefore that the district court did not err in granting summary judgment.

(...)

CellPro can carry its burden only by showing that all of the disclosed alternative modes are insufficient to enable the claims, because "the enablement requirement is met if the description enables any mode of making and using the invention." Engel Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 1533, 20 U.S.P.Q.2D (BNA) 1300, 1304 (Fed. Cir. 1991). CellPro's silence concerning enablement by use of the KG-1/KG-1a cell lines makes its argument on this point specious.



And recall discussion of Chester v. Miller in Target v Williams Advanced Materials, 2007 U.S. Dist. LEXIS 98344 : See Chester v. Miller, 906 F.2d 1574, 1577 (Fed. Cir. 1990) (discussing possibility that broader claim for a genus might not be enabled by a parent patent's disclosure of a species for purposes of filing date, yet the parent's species claim could still anticipate the later genus claim).

UPDATE on April 22, from a comment on Patent Docs on April 20:

The decisive lack of "Reasonable Expectation of Success" finding whereby inventive skill would have been required to transition the disclosed Doudna CRISPR technology platform from prokaryotes (e.g. bacteria) to eukaryotes (e.g. mammalian cells) seems doubtful when considering the course of the scientific literature that parallels the numerous patent filings.

The technical aspects of Doudna's CRISPR discoveries are embodied in a Science article (Jinek et al) e-published on June 28, 2012.

The BROAD/MIT group filed their "eukaryotic" CRISPR application on December 12, 2012. The counterpart scientific paper was published on January 3, 2013 (Cong et al).

To my knowledge, Science requires a peer review process prior to publication, usually requiring 1-2 months.

Consequently, the incredibly quick turnaround from Jinek to Cong, where Zhang managed to develop and execute extensive lab protocols that produced new, verifiable results in just a matter of weeks suggests that Doudna's findings indeed provided Zhang with a RES that the eukaryotic system would be amenable in supporting Doudna's CRISPR platform, as Doudna suggests in the Jinek article.

This, especially since Zhang merely applied known technologies (NLS sequences, used since the 1980s) in order to guide the CRISPR system into the eukaryotic cell compartments.

Accordingly, it is apparent that the PTAB might have erred in their findings by being dismissive of the science itself.

More on The Medicines Company v. Mylan, 2017 U.S. App. LEXIS 5947. Reverse doctrine of equivalents?

The case The Medicines Company v. Mylan, 2017 U.S. App. LEXIS 5947, is unusual in several respects. Although a counterclaim of invalidity had been lodged, the question of invalidity was not reached, even though there were significant questions of indefiniteness and functional claiming.

For example claim 1 of the '727 patent had a "wherein" clause, which amounted to claiming a result, without utilizing means for language:


1. Pharmaceutical batches of a drug product comprising bivalirudin . . . wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6% as measured by HPLC.



Of functional, result-defined claiming, the CAFC wrote:


Although functional limitations in patent claims are not per se objectionable even when the means-plus-function format is not invoked,6 they cannot be "so broad that [they] cause[] the claim to have a potential scope of protection beyond that which is justified by the specification disclosure." In re Swinehart, 439 F.2d 210, 213, 58 C.C.P.A. 1027 (C.C.P.A. 1971). Here, Medicines' construction would [*23] expand the scope of "efficient mixing" to cover any way of mixing that achieves a compounding solution having an Asp9 level of less than 0.6 percent. The patentee's construction of "efficient mixing" thus attempts to claim all solutions to the identified "impurities" problem, without describing the entire range of solutions to that problem. Medicines' construction is therefore not permissible. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352-53 (Fed. Cir. 2010) (en banc) ("Such claims merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any [solution] later actually invented and determined to fall within the claim's functional boundaries—leaving it to [others] to complete an unfinished invention."); see also Bayer Crop Science AG v. Dow AgroSciences LLC, 728 F.3d 1324, 1330-31 (Fed. Cir. 2013). Rather, efficient mixing must be defined in terms of the particular process or processes identified in the specification.



Footnote 6 is not about case law on functional claiming without means plus function language, but RATHER:


There is no contention here that the claims are means-plus-function claims governed by 35 U.S.C. § 112(f) (formerly 35 U.S.C. § 112 ¶ 6).



** A law review by KEVIN EMERSON COLLINS in 90 Wash. U. L. Rev. 1399 (2013) suggests that the discussion of the CAFC on functional claiming might not be completely accurate:



In the first half of the twentieth century, the Supreme Court made explicit its objection to functional claims. The Court invalidated a series of patent claims on the grounds that the claims were overbroad because they only recited the functional properties of technology that an inventor had produced and thus were not limited to an inventor's actual invention. n109 As [*1428] a mid-twentieth-century patent treatise noted: "It is possible that a claim for all means of arriving at a desired result would be broad enough to cover later discovered means wholly independent of the first means for arriving at the same final result. In that case, the inventor would be over-protected." n110 In this passage, "means" is code for a technology with particular structural properties, and "a desired result" is a functional property.

In Holland Furniture Co. v. Perkins Glue Co., n111 an inventor developed a starch-based glue that was useful for wood veneering because, among its properties, it had the low water content that previously had only been attainable in glue made from animal substances. n112 The inventor obtained a functional claim to any starch-based glue "having substantially the properties of animal glue." n113 Claim scope was thus delineated "not in terms of [the invention's] own physical characteristics or chemical properties ... but wholly in terms of the manner of use of the product." n114 The Su-preme Court invalidated the claim because it employed only functional limitations. "A claim so broad, if allowed, would operate to enable the inventor who has discovered that a defined type of starch answers the required purpose to exclude others from all other types of starch" with different chemical compositions. n115

In General Electric Co. v. Wabash Appliance Corp., n116 an inventor obtained a functional claim that encompassed tungsten filaments "made up mainly of a number of comparatively large grains of such size and contour as to prevent substantial sagging and offsetting during a normal or commercially useful life for ... a lamp or other device." n117 The Supreme Court held the claim "invalid on its face" because of its functional language. n118 "The claim ... falls within the condemnation of the doctrine that a patentee may not broaden his product claims by describing the [*1429] product in terms of function" and "vividly illustrates the vice of a description in terms of function" in a claim. n119
Similarly, in Halliburton Oil Well Cementing Co. v. Walker, an inventor made an improvement in a device that records the echoes of sound waves sent into an oil well in order to measure well depth. n120 The inventor limited the scope of his claim with reference to a "means ... for tuning [an echo-recording device] to the frequency of echoes ... to clearly distinguish the echoes ... from ... each other." n121 The Court invalidated the claim, noting that the claim de-scribed the invention "in terms of what it will do rather than in terms of its own physical characteristics" and opining that the claim illustrated the "overhanging threat of the functional claim." n122

The Supreme Court cases barring purely functional claims because of overbreadth remain good law today, but Congress has softened their impact. Describing the full scope of an invention without using functional limitations is sometimes difficult, and invalidating any claim with a functional limitation might leave inventors without effective patent protection. Therefore, Congress responded to Halliburton by enacting what is now section 112(f) as part of the 1952 Patent Act:
[p. 1430]

An element in a claim ... may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. n123





** As to Cardinal Chemical, the latitude for not entertaining invalidity questions is narrow, and not consistent with the facts of Mylan, wherein invalidity was the bigger issue.


In Liebel Flarsheim, the district court [2002 U.S. Dist. LEXIS 8891, later reversed in 358 F.3d 898 ] wrote of Cardinal Chemical:


Having found non-infringement in favor of Medrad, L-F argues that the Court should dismiss Medrad's invalidity and unenforceability counterclaims as moot. (Doc. No. 276, p.9). Medrad, on the other hand, argues that this Court does not have the authority to dismiss its invalidity and unenforceability counterclaims as moot because, according to Medrad, the United States Supreme Court has held that a finding of non-infringement does not moot an invalidity counterclaim. See Cardinal Chemical Co. v. Morton Int'l., Inc., 508 U.S. 83, 124 L. Ed. 2d 1, 113 S. Ct. 1967 (1993). (Doc. No. 274).
In Cardinal Chemical, the Supreme Court rejected the Federal Circuit's practice of routinely vacating declaratory judgments of invalidity as moot when it affirmed a district court's determination of non-infringement. 508 U.S. at 102-03. The Court concluded that an appellate court's affirmation of a district court's non-infringement ruling did not affect the appellate court's power to review the invalidity issue. 508 U.S. at 98. Furthermore, the Court observed that there were strong public policy and practical reasons for addressing the issue of invalidity regardless of the outcome of the question of infringement. 508 U.S. at 102-01. Thus, the Court ruled that HN1Go to this Headnote in the case.the Federal Circuit should not automatically vacate a district court's ruling of invalidity as moot based solely on a finding of non-infringement. 508 U.S. at 103-04.
While Cardinal Chemical is instructive, it is not dispositive of the issue currently before this Court -- whether a district court has the discretion to dismiss an invalidity counterclaim as moot in light of a finding of non-infringement. The Cardinal Chemical court specifically limited its holding to "the jurisdiction of an intermediate appellate court -- not the jurisdiction of either a trial court or [the Supreme] Court"). 508 U.S. at 95. Furthermore, while indicating a preference for resolving validity questions, the Cardinal Chemical court did not establish a per se rule that an invalidity counterclaim could never be mooted by a finding of non-infringement. Rather, the Court held that declaring an invalidity counterclaim moot based solely on a finding of non-infringement was an abuse of discretion on the part of an appellate court:
In rejecting the Federal Circuit's practice we acknowledge that factors in an unusual case might justify that court's refusal to reach the merits of a validity determination -- a determination which it might therefore be appropriate to vacate. A finding of non-infringement alone, however, does not justify such a result. Nor does anything else in the record of this case. The two patents at issue here have been the subject of three separate lawsuits, and both parties have urged the Federal Circuit to resolve their ongoing dispute over the issue of validity; it would be an abuse of discretion not to decide that question in this case.
508 U.S. at 102-03 (emphasis added). Thus, the Court left open the possibility that even an appellate court could refuse to reach to merits of an invalidity [*8] question if other factors, in addition to a finding of non-infringement, weighed in favor of finding the invalidity question moot. 3

Footnote 3

3 Confusion over the ultimate holding of Cardinal Chemical stems, in part, from the following statement that appears in the case: "[the invalidity counterclaim] did not become moot when [the appellate] court affirmed the finding of non-infringement". Cardinal Chemical, 508 U.S. 98, 124 L. Ed. 2d 1, 113 S. Ct. 1967. This statement's meaning, however, is only apparent when read in the context of the entire opinion. The statement appears in the section of the opinion in which the Court concludes that a controversy continues to exist for the purpose of establishing jurisdiction until a court is made aware of a change in circumstances that eliminates the controversy. Id. Because no such change of circumstances had occurred in Cardinal Chemical, the Court concluded that the appellate court had the power (i.e., jurisdiction) to review the invalidity issue. Id. The statement's inclusion in a discussion of jurisdiction indicates that the Court was referring to jurisdictional mootness. See Morton Int'l, Inc. v. Cardinal Chemical Co., 967 F.2d 1571, 1574 (Fed. Cir. 1992)(Nies, C.J. dissenting)("'Mootness' is jurisdictional when the dispute between the parties, or at least an issue in the case, no longer exists. That is, the issue no longer presents an actual case or controversy. If an issue is moot in this sense, a court has no discretion but must dismiss for lack of jurisdiction. (citations omitted)").

The ultimate holding of the Cardinal Chemical case was that in the case.dismissing an invalidity counterclaim as moot based a finding of non-infringement alone and in the absence of any other factors justifying the refusal to reach the merits of a validity determination was an abuse of discretion, implying that if appropriate factors exist, an invalidity counterclaim may be moot. Cardinal Chemical, 508 U.S. at 102-03. This type of mootness is referred to as prudential mootness. See Morton, 967 F.2d at 1574. ("An issue is also said to be 'mooted' when a court, having decided one dispositive issue, chooses not to address another equally dispositive issue. In this sense, mootness means only that a decision on another issue would have no practical significance. This type of mootness results from prudential, not jurisdictional, considerations." (citations omitted)).

End Footnote 3 here

The issue of whether a district court, versus an appellate court, may dismiss an invalidity counterclaim as moot following a finding of non-infringement was addressed in Phonometrics, Inc. v. Northern Telecom Inc., 133 F.3d 1459 (Fed. Cir. 1998). In that case, the plaintiff patent owner brought an action against various manufacturers and sellers of telephone equipment alleging infringement of its patent. Id. at 1461-63. The defendants counterclaimed seeking a declaratory judgment for non-infringement, invalidity, and unenforceability of the patent. Id. The district court ruled in favor of the defendants on the issue of non-infringement and dismissed their invalidity and unenforceability counterclaims as moot. The plaintiff appealed both the finding of non-infringement and the dismissal of the defendants' counterclaims, arguing it had a "general interest in a judicial determination of its patent's validity." Id. at 1468.
With respect to the dismissal of the counterclaim for invalidity, the appellate court concluded that it was within a district court's discretion to dismiss the counterclaims as moot where it makes a finding of [*10] non-infringement:
We have previously held that a district court has discretion to dismiss a counterclaim alleging that a patent is invalid as moot where it finds no infringement. See Nestier Corp. v. Menasha Corp.-Lewisystems Div., 739 F.2d 1576, 1580-81, 222 USPQ 747, 751 (Fed. Cir. 1984)("There was no reversible error or abuse of discretion . . . in the District Court's withholding of judgment on the issues related to the . . . patent's validity -- despite the jury's having found the patent not invalid -- in light of the jury's finding of non-infringement."); see also Leesona Corp. v. United States, 208 Ct.Cl. 871, 530 F.2d 896, 906 n. 9, 185 USPQ 156, 163 n. 9 (adopted as opinion of Court of Claims at 208 Ct.Cl. 871, 530 F.2d 896, 192 USPQ 672 (1976))("While the better practice is to treat both the validity and infringement issues . . . it is not always necessary to do so. Where, as here, noninfringement is clear and invalidity is not plainly evident it is appropriate to treat only the infringement issue." (citations omitted)).
Id. The court concluded that the Cardinal Chemical case was distinguishable because [*11] it involved the authority of an intermediate appellate court rather than a district court:

The Supreme Court's decision in Cardinal Chemical Co. v. Morton International, 508 U.S. 83, 113 S. Ct. 1967, 124 L. Ed. 2d 1, 26 USPQ2d 1721 (1993), does not preclude this discretionary action by the district court. Cardinal Chemical simply prohibits us, as an intermediate appellate court, from vacating a judgment of invalidity when we conclude that a patent has not been infringed, and therefore has no bearing on the district court's actions in this case.
Id. 4




Footnote 1 of The Medicines Company v. Mylan, 2017 U.S. App. LEXIS 5947, includes the text:



Under Cardinal Chemical Co. v. Morton Int'l, Inc., 508 U.S. 83, 99, 113 S. Ct. 1967, 124 L. Ed. 2d 1 (1993), a finding of noninfringement cannot moot a counterclaim of invalidity, but we retain the discretion to limit the grounds upon which appeals are decided. Here, because Mylan has agreed that a judgment of noninfringement with respect to both patents in suit "would be tantamount to the relief sought on the merits" and that we need not reach the invalidity issues, we decline to reach the merits of Mylan's invalidity contentions. See Old Town Canoe Co. v. Confluence Holdings Corp., 448 F.3d 1309, 1318 n.2 (Fed. Cir. 2006).


In the Mylan case, the CAFC discussed INVALIDITY issues, and even cited a CAFC decision in Cardinal Chemical:


A claim is indefinite if its legal scope is not clear enough that a person of ordinary skill in the art could determine whether a particular composition infringes or not."); Morton Int'l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993) ("[C]laims. . . [must be] sufficiently precise to permit a [*16] potential competitor to determine whether or not he is infringing.").



But the Mylan case is manifestly about infringement/not validity.

The Mylan decision talks about the written description of the '727 patent:



We conclude that one of ordinary skill in the art would rely on Example 5 to ascertain the metes and bounds of "efficiently mixing." As the only embodiment of efficient mixing, Example 5 is "highly indicative of the scope of the claims." Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1355 (Fed. Cir. 1998).8 Example 5, however, is not merely the only disclosed embodiment of efficient mixing—it is the only description of efficient mixing in the patents in suit that casts light on what efficient mixing is and that enables one of ordinary skill in the art to achieve the objects of the claimed invention. Although the specification provides that Example 5 is "non-limiting," e.g., '727 patent, col. 16 l. 6, no other part of the patents' written description sufficiently teaches the affirmative steps that constitute efficient mixing. In this circumstance, we think it entirely appropriate to limit the term "efficiently mixing" to the sole portion of the specification that adequately discloses "efficient mixing" to the public. See Alloc, Inc. v. ITC, 342 F.3d 1361, 1370 (Fed. Cir. 2003); SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1344-45 (Fed. Cir. 2001).



The cited Alloc case had noted:


this court recognizes that in the case.it must interpret the claims in light of the specification, Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff'd 517 U.S. 370, 134 L. Ed. 2d 577, 116 S. Ct. 1384 (1996), yet avoid impermissibly importing limitations from the specification. Comark Communications v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998). That balance turns on how the specification characterizes the claimed invention. Sunrace Roots Enter. Co., LTD v. SRAM Corp., 336 F.3d 1298, 1305 (Fed. Cir. 2003). In this respect, this court looks to whether the specification refers to a limitation only as a part of less than all possible embodiments or whether the specification read as a whole suggests that the very character of the invention requires the limitation be a part of every embodiment. For example, it is impermissible to read the one and only disclosed embodiment into a claim without other indicia that the patentee so intended to limit the invention. [**20] Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002). On the other hand, where the specification makes clear at various points that the claimed invention is narrower than the claim language might imply, it is entirely permissible and proper to limit the claims. SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1345 (Fed. Cir. 2001).





After a lengthy discussion of what "efficient mixing" is limited to, the CAFC quickly disposes of infringement issues:


The net effect of our claim construction is that to infringe either the '727 patent or the '343 patent, infringing batches must be compounded using a process that employs the efficient mixing conditions of Example 5. See Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1291-95 (Fed. Cir. 2009) (en banc). Under this claim construction, Mylan's ANDA does not infringe the asserted claims since is undisputed that, for example, Mylan does not use multiple mixing devices as required by Example 5.


One wonders if what happened in the Mylan case, as referenced to the Alloc case, is simply the "reverse doctrine of equivalents" masquerading under a different name. Without invoking the narrowed claim construction, one says simply that Mylan obtained the Asp9-bivalirudin level in a different way than taught by the patentee.

Separately, lurking in the background, is the problem that it might seem the CAFC limited the '727 claim to preserve its validity as to a written description/enablement attack. BUT the court will not re-write claims in order to preserve their validity. See Pfizer, Inc. v. Ranbaxy Laboratories Ltd., 457 F.3d 1284, 1292 (Fed. Cir. 2006).
"Preserving validity" does not permit the Court to re-write the claims in a manner inconsistent with the intrinsic record in order to preserve validity of the claims. McCarty v. Lehigh Valley R.R. Co., 160 U.S. 110, 116, 40 L. Ed. 358, 16 S. Ct. 240, 1895 Dec. Comm'r Pat. 721 (1895); Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357 (Fed. Cir. 1999) ("We must construe the claims based on the patentee's version of the claim as he himself drafted it."); Quantum Corp. v. Rodime, PLC, 65 F.3d 1577, 1584 (Fed. Cir. 1995) ("Although we construe claims, if possible, so as to sustain their validity, it is well settled that no matter how great the temptations of fairness or policy making, courts do not redraft claims."); Becton Dickinson & Co. v. C.R. Bard Inc., 922 F.2d 792, 799 n.6 (Fed. Cir. 1990) ("Nothing in any precedent permits judicial redrafting of claims. At most there are admonitions to construe words in claims narrowly, if possible, so as to sustain their validity.")

On the record, it might seem patentee intended a broad scope for "efficient mixing." And, validity was not at issue in the Mylan case, as decided.


**In passing, see also
http://www.patenthawk.com/blog/2005/11/clonetech_gets_clobbered.html

**And from blawgsearch, on 18 April 2017:

A significant April 16 in the American Civil War

On the night of April 16, 1863, Union gunboats ran past the Confederate defenses at Vicksburg. The citizens of
Vicksburg had been told Grant was retreating to Memphis, but a big dance event that night was interrupted by
Confederate cannon fire, which disabled no gunboat.

Was Medicines v. Mylan, in effect, a reverse doctrine of equivalents case?

In a post related to UC/Berkeley's appeal to the CAFC of an unfavorable PTAB decision (no interference in fact in CRISPR dispute with the Broad), the Patent Docs blog had comments concerning a hypothetical future invocation of a reverse doctrine of equivalents defense to a charge of infringement of hypothetical claims of a hypothetical future UC Berkeley patent:


ScottE:

Kevin-Do you think the UC patent claims, if granted, will be susceptible to a reverse doctrine of equivalents argument if and when they are applied to eukaryotic cells? Does lack of a reasonable expectation that this process would work in eukaryotic cells warrant the application of this doctrine to limit the effective scope of UC's claims?

Kevin Noonan:

ScottE: I was just discussing the reverse doctrine the other day, and here is a quote from Roche v. Apotex (Fed. Cir. 2008):

"The reverse doctrine of equivalents is rarely applied, and this court has never affirmed a finding of non-infringement under the reverse doctrine of equivalents."

I think it more likely that an accused infringer, armed with a license from the Broad, would argue that Berkley's patents would be invalid under Sec. 112 if construed to encompass mammalian cells, because it would have been undue experimentation to apply the technology due to the unpredictability of the art, lack of examples in UC's specification, and undue breadth of the claims.

But r-DOE is a creative argument so it may be in an accused infringer's arsenal.

Thanks for the comment.





IPBiz has discussed the reverse doctrine of equivalents (e.g.,
SRI v Matsushita: reverse doctrine of equivalents )

One wonders if the net result of Medicines Company v. Mylan was simply an application of the reverse doctrine of equivalents, by another name?

For example, from footnote 10:






While we also disagree with the district court’s
construction of “efficient mixing” as “not using inefficient
mixing conditions such as described in Example 4,” the
district court correctly concluded that Mylan did not
infringe the ’343 patent under this construction because
Mylan’s compounding process was “more inefficient” than
Example 4. Medicines, 2013 WL 6633085, at *9.



Mylan got the same (functional) result in a different ("more inefficient") way,
and did not infringe. Is this not what Justice Jackson was describing in Graver Tank:


[W]here a device is so far changed in principle from a patented article that it performs the same or a similar function in a substantially different way, but nevertheless falls within the literal words of the claim, the doctrine of equivalents may be used to restrict the claim and defeat the patentee's action for infringement.



See April 6 IPBiz post


CAFC in Medicines v. Mylan. Claim term limited to the sole portion of the specification that adequately discloses term

See also


UC/Berkeley to appeal adverse PTAB decision in CRISPR case

Core Wireless loses appeal against Apple at CAFC

From the beginning of the decision:



This appeal arises from a patent infringement action
brought in the United States District Court for the Eastern
District of Texas. The plaintiff, Core Wireless Licensing
S.a.r.l., is the owner of U.S. Patent No. 6,978,143 (“the
’143 patent”). Claim 17 of the patent, the only claim at
issue in this appeal, recites a mobile station, such as a
mobile telephone, that is connected to a cellular system or
network. The claim is directed to means for sending
packet data from the mobile station to the network using
a selected channel.

Following trial, the jury found that the defendant,
Apple Inc., did not infringe any of the asserted claims.
The district court denied Core Wireless’s motion for
judgment as a matter of law, and Core Wireless took this
appeal. We affirm.


There was an issue with the "what the magistrate said":



The problem with Core Wireless’s argument is that
the premise is incorrect: The magistrate judge did not
clearly reject Apple’s position and adopt Core Wireless’s
position. Core Wireless bases its argument on the magistrate
judge’s failure to include certain language, proposed
by Apple, in the description of the corresponding structure
for performing the “means for comparing” limitation. As
Core Wireless points out, the magistrate judge did not
include Apple’s suggested language that control unit 803
“provide[s] the comparison result to a channel selection
function within the mobile station” and Apple’s reference
to step 660 of Figure 6 in the patent. Those exclusions,
Core Wireless contends, indicate that the magistrate
judge rejected Apple’s position on the construction of that
limitation.
We disagree. The magistrate judge did not state at
the hearing or include in his order any explanation for
omitting Apple’s proposed text from the claim construction.




This is a "means plus function" case:



Claim 17 is a means-plus-function claim and thus is
controlled by 35 U.S.C. § 112, ¶6 (now codified as section
112(f) under the America Invents Act, which does not
apply to this case). As such, claim 17 covers any device
that performs the function recited in the claim with
structure described in the specification or its equivalents.
Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931,
934 (Fed. Cir. 1987) (en banc).


Notice that extrinsic evidence arose:



Similarly, in a contemporaneous presentation made to
the European Telecommunications Standards Institute,
the inventor described his proposal as one in which the
mobile station “itself should be able to make decision
whether to send data packets on [the common channel] or
whether to request a [dedicated channel]. Otherwise
there will be unnecessary signalling [sic] . . . before [the
mobile station] can send a data packet on the [common]
channel.” Although Core Wireless argues that the proposal
represents only a “subset” of the invention disclosed
in the ’143 patent, the proposal—like the patent—is clear
that the invention requires the mobile station to make the
selection decision in order to solve the prior art problem.
The language of that proposal provides further support for
the district court’s ruling in the JMOL opinion that claim
17 of the ’143 patent requires that the mobile station
must have the capability to make channel selection decisions.