Friday, February 16, 2018

Snap-on wins claim construction argument at CAFC but still loses appeal

Snap-on challenged patents via IPR, lost, appealed, and then lost at the CAFC:

Snap-on Incorporated (Snap-on) appeals from the final
written decisions of the Patent Trial and Appeal
Board (Board) in the above-captioned inter partes review
proceedings (IPRs) that found certain claims of three of
Appellees’ patents to be nonobvious over prior art combinations
argued by Snap-on.

Of interest, Snap-on won on claim construction but lost
via the "substantial evidence" standard:

Snap-on also argues that the Board erred in “entirely
read[ing] out” the term “average” in its construction.
Snap-on Open. Br. 33. We agree. As a general matter, we
construe a claim term to take on its plain and ordinary
meaning to one of skill in the art when read in the context
of the specification and prosecution history. Wasica Fin.
GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1282 (Fed.
Cir. 2017). Appellees’ own cited expert testimony states:
One of ordinary skill in the art in relation to the
patents in suit would have understood that the
term “average discharge current greater than or
equal to approximately 20 amps” as used in the
patents in suit referred primarily to the capability
of providing an average discharge current of approximately
20 amps, and that it included the operational
range of currents for battery packs for
hand held power tools.

J.A. 12336–37 (emphasis added). Thus, Appellees’ own
expert included the word “average” in his stated interpretation
of the 20-Amp Limitation.

Appellees nevertheless argue that omission of the
word “average” from the Board’s construction is supported
by evidence in the record showing that batteries were
commonly tested using “[c]onstant current discharge
tests” that held current constant while measuring voltage.
Resp. Br. 42 (citing J.A. 3898–99). While this may be
true, there is no indication in the specification4 that this
sort of testing should limit the plain and ordinary meaning
of “average,” which would include situations when
current rises above and dips below the 20-amp target so
long as the average discharge current over the entire
rated capacity is 20 amps or greater.
The specification references the 20-Amp Limitation in
only one place:
In some constructions, the battery pack 30 can
power various power tools (including a driver drill
300 and circular saw 305) having high discharge
current rates. For example, the battery pack 30
can supply an average discharge current that is
equal to or greater than approximately 20 A, and
can have an ampere-hour capacity of approximately
3.0 A-h.
J.A. 267, ’290 patent col. 10 ll. 20–26. Snap-on argues,
and Appellees do not dispute, that a battery pack discharges
current in bursts when used with a circular saw,
such that the current would swing above and below 20
amps. The fact that the phrase “average discharge current”
is only used in the portion of the specification describing
an “example” of embodiments that undisputedly
discharge current at levels that swing above and below 20
amps shows that the word “average” should take on its
ordinary meaning, especially given the Board’s obligation
to use the broadest reasonable construction in IPRs.
Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142
For the foregoing reasons, we hold that the correct
claim construction of the 20-Amp Limitation is: “the
battery cells, when configured together in a battery pack,
are capable of producing, on average, reasonably close to
20 amps of discharge current or greater over the course of
delivering their entire rated capacity.” Although the
Board erred in omitting the word “average” from its
construction, the Board’s fact findings regarding obviousness
are still supported by substantial evidence and the
Board’s legal determinations of obviousness are correct
under the proper claim construction.5 The harmless error
rule applies to appeals from the Board. See, e.g., In re
Watts, 354 F.3d 1362, 1369 (Fed. Cir. 2004). Re

Wednesday, February 14, 2018

Dealing with choices in disease treatment

Back in law school, I wrote a column for the University of Chicago Phoenix on the "Let's Make a Deal" problem of accepting Monty Hall's offer to switch doors. The correct answer is to switch doors, and you will win 2/3 of the time.

In the October 1998 issue of Intellectual Property Today, I reviewed the matter:


Of my columns for my law school newspaper, the most discussed was the presentation of the "Let's Make a Deal" problem. On seeing it, most people get it wrong, although on discussion, most people get it right. Some never do. On August 6, I was explaining it to a former colleague of mine as we rode the PATH to the World Trade Center. He got it wrong. More interestingly, a stranger who was listening to us, who claimed to be a Ph.D. in statistics from Harvard, intervened to argue for the wrong position. At that point, I thought it worthwhile to resurrect the material.


The set-up of the problem arises from a game show, begun in the 1960's and hosted by Monty Hall, entitled "Let's Make a Deal." There were three doors, behind only one of which was a valuable prize. After some preliminaries, a contestant would choose one door from among the three. The selected door remained closed. At this point, Monty would sometimes open one of the two unchosen doors, behind which was no prize. Monty would then offer the contestant the opportunity to switch choice from the initially-chosen door to the remaining unopened door. The question is simply: should the contestant switch?
Most people see the situation as one of equal probability. There are two unopened doors, and behind one of them is the prize. In fact, by switching choice, one wins two times out of three. The key point is that there are three states of the system, not two.
To work through the situation, let's assume the contestant picks door number 1. One-third of the time, the prize will be behind door number 1, and the contestant will win if does not change and he will lose if he changes. Two thirds of the time, the prize will not be behind door number 1 (one third of the time behind door number 2; one third of the time behind door number 3). The contestant will lose if he does not change and he will win if changes. One could stop here.
However, the difficulty arises when one confronts the opening of the door without a prize. There are two doors left, and one prize, ergo a seeming probability of one-half. But, because Monty cannot open the initially-selected door of the contestant, he cannot change the probability as to that door. It will remain at one third. Some people do not find this correct.
Instead of the "three door" problem, visualize a lottery with one million tickets, only one of which is a winner. You buy one ticket and put it in your pocket. Monty, who knows which ticket is a winner, tears up 999,998 losing tickets and offers to trade you his ticket for yours. There are only two tickets left and one is a winner. Do you think the probability is 50/50?
There are many messages from this problem. I'll consider two.


If you understand the problem, you will switch doors and you will win 2/3 of the time. The elimination of the one door gave added knowledge. The probabilities were not 50/50.
Did you ever wonder why appellate panels have more than one member? Assuming a district judge and an appellate judge have the same probability of "getting it right", and that the probability is greater than 50%, a panel will give the right answer more frequently than the single judge.
To take a simple case, let us assume that a given judge has a probability of getting the right answer (2/3) of the time, and that this probability is independent of the analysis of the other judges. Consider a three judge panel which requires at least a 2-1 vote for a decision. The joint probability of getting it right is 20/27 (=74.1%), which comprises the 3-0 vote (8/27=(2/3)<3>) and three 2-1 votes (each of joint probability 4/27). This is 11.1% higher than the probability the single judge will get it right ((74.1-66.7)/66.7).

An interesting twist on this involves the choice to employ a drug.

Imagine that you have a certain disease that is not life threatening but greatly diminishes quality of life. There is a treatment that will be effective in removing symptoms 2/3 of the time, but ineffective 1/3 of the time. Good idea to try it.

HOWEVER, there is an additional factor. In the 1/3 of the time the treatment does not work, you develop an additional problem.

If the problem were death, likely this would be a bad idea. But suppose the problem is the development of another disease (similar to the first), so that 1/3 of the time you don't solve the initial problem AND you develop a new problem, making your situation "twice" as bad as when you started. What do you do?

See also

"Let's Make a Deal" problem

Monday, February 12, 2018

Appellant Kenneth Hodges prevails at CAFC

The appellant Hodges got some traction at the CAFC:

Appellant Kenneth Andrew Hodges appeals from examination
of U.S. Patent Application No. 12/906,222
(“’222 application”), in which the Patent Trial and Appeal
Board (“Board”) affirmed the examiner’s rejection of all
claims as anticipated and/or obvious. See Ex Parte Kenneth
Andrew Hodges, No. 2014-009710, 2016 WL 6441834
(P.T.A.B. Oct. 28, 2016). For the following reasons, we
reverse the Board’s anticipation determinations, vacate
its obviousness determinations, and remand for further

There was an "inherent" argument in the Examiner's
anticipation rejection:

Thus, as the Board noted, the propriety of the examiner’s
rejection turns on whether Rasmussen’s unlabeled
valve containing the inlet seat is “define[d]” by Rasmussen’s
valve body—i.e., whether it “can properly be consid-
ered to be a part of Rasmussen’s drain valve body.”
Hodges, 2016 WL 6441834, at *2. The Board found that it
could. In particular, the Board found that Rasmussen’s
unlabeled valve is “connected to, and therefore allow[s] or
prevent[s] flow into, inlet port 17A,” and that the seat of
the unlabeled valve would therefore “be ‘an internal part’
of and contained within the ‘outer casing’ of drain valve
10.” Id. That finding is unsupported by substantial


The Board neither supported its assertion of
similarity, however, nor explained how the positioning of
the unlabeled valve in Rasmussen’s Figure 7 would enable
a skilled artisan to “practice the invention without
undue experimentation.” Spansion, 629 F.3d at 1356
(internal quotation marks omitted). And, even if Rasmussen’s
unlabeled valve is ostensibly “similar to” the ’222
application’s second member 16 in some respects, it is
different in the only respect that is relevant to the claims
at issue—i.e., it is not an internal part of or contained
within the valve body. We therefore conclude that substantial
evidence does not support the Board’s anticipation

Of note:

The Patent Office shoulders the burden during initial
examination of establishing that the examined claims are
anticipated. See 35 U.S.C. § 102 (“A person shall be
entitled to a patent unless[] . . . .”); cf. In re Oetiker, 977
F.2d 1443, 1445 (Fed. Cir. 1992) (“If examination at the
initial stage does not produce a prima facie case of unpatentability,
then without more the applicant is entitled
to grant of the patent.”). Because the Board failed to meet
that burden here, and because the only permissible finding
that can be drawn from Rasmussen is that it does not
disclose the claim limitation at issue, we reverse the
Board’s anticipation determination with respect to Rasmussen
as to appealed claims 1–3 and 5–8.

Footnote 7:

The dissent asserts that we may reverse the
Board’s patentability determinations in only two circumstances—i.e.,
when the Board (1) “committed legal error
and no further factual findings are required,” or (2) “made
erroneous factual findings and only one permissible
factual finding exists.” Dissent at 2–3 (internal quotation
marks omitted). Whether or not the dissent is correct
that these are the only two circumstances in which reversal
is permitted, its conclusion that this case does not fit
within the second circumstance is incorrect. As described
above, the Board’s finding that the inlet seat within
Rasmussen’s unlabeled valve is contained in Rasmussen’s
housing is plainly contrary to the only permissible factual
finding that can be drawn from Rasmussen itself. This
case therefore fits squarely within the second circumstance
identified by the dissent.


We therefore reverse the Board’s anticipation determination
based on Frantz as to appealed claims 1–2 and
21. See Smith, 871 F.3d at 1382–84 (reversing the
Board’s anticipation finding predicated on an unreasonably
broad claim construction); In re Skvorecz, 580 F.3d
1262, 1267–68 (Fed. Cir. 2009) (reversing the Board’s
rejection of reissue claims predicated on an incorrect
construction, and noting that “[a]nticipation cannot be
found, as a matter of law, if any claimed element or
limitation is not present in the reference”).

Of obviousness:

The Board concluded in a single paragraph that the
claims would have been obvious over Rasmussen in view
of Frantz because the unlabeled valve depicted in Rasmussen’s
Figure 7 could be made part of Rasmussen’s
drain valve body such that the seat of the unlabeled valve
would be “‘an internal part’ of and contained within the
‘outer casing’ of drain valve 10.” Hodges, 2016 WL
6441834, at *5. But the Board did not explain how Rasmussen’s
drain valve assembly could be so modified. In
another paragraph, the Board agreed with the examiner
that it also “would have been obvious to a skilled artisan
to include Rasmussen’s sensor in Frantz’s valve body for
the purposes of generating a control signal that purges a
high condensate level from Frantz’ [sic] [main] chamber.”
Id. (internal quotation marks omitted). But the Board did
not explain how such a sensor would be downstream of
the inlet seat and generate a signal reflective of a pressure
downstream of said inlet seat, as required by the
claims. Instead, the Board merely determined that the
claims would have been obvious over Frantz in view of
Rasmussen “[f]or the same reasons as presented above.”
Id. The Board made no findings, moreover, regarding the
obviousness factors laid out in Graham v. John Deere Co.
of Kan. City, 383 U.S. 1 (1966).
Our review of the Board’s decision “is rooted not just
in the law of obviousness but in basic principles of administrative
law.” Personal Web Techs., LLC v. Apple, Inc.,
848 F.3d 987, 992 (Fed. Cir. 2017). The Board must
therefore “explicate its factual conclusions, enabling us to
verify readily whether those conclusions are indeed supported
by ‘substantial evidence’ contained within the
record.” Gartside, 203 F.3d at 1314; see also Power Integrations,
Inc. v. Lee, 797 F.3d 1318, 1326–27 (Fed. Cir.
2015) (holding that the Board’s reasoning must be set out
“in sufficient detail to permit meaningful appellate review”).
The Board did not do so here. Unlike the Board’s
anticipation determinations, which contravene the only
permissible findings that can be drawn from the prior art
under the proper constructions of the relevant claim
terms, the Board’s obviousness determinations involve
“potentially lawful but insufficiently or inappropriately
explained” factual findings, In re Van Os, 844 F.3d 1359,
1362 (Fed. Cir. 2017)

When faced with similarly deficient factual findings,
“we have consistently vacated and remanded for further
proceedings.” Id. (collecting cases); Icon Health & Fitness,
Inc. v. Strava, Inc., 849 F.3d 1034, 1046 (Fed. Cir. 2017)
(“Although the [Board] made a factual finding, this finding
did not have an adequate basis in the record, and the
[Board] did not adequately explain its reasoning. Thus,
we vacate and remand for additional [Board] findings and
explanation.”); Personal Web Techs., 848 F.3d at 994
(vacating and remanding “for the Board to reconsider the
merits of the obviousness challenge, within proper procedural
constraints”); see also Fla. Power & Light Co. v.
Lorion, 470 U.S. 729, 744 (1985) (explaining that, when
an agency’s fact-findings and explanation are deficient,
“the proper course, except in rare circumstances, is to
remand to the agency for additional investigation or
We therefore vacate the Board’s obviousness rejections
with respect to appealed claims 1–3, 5–8, and 21,
and remand for further factual findings and explanation
on this score.

"But nothing can ever truly be deleted on the Internet"

A post titled Boston police sent Black History Month tribute to Red Auerbach and people were not happy contains the text

But nothing can ever truly be deleted on the Internet.

IPBiz is not so sure. Vai Sikahema's polemic "Rutgers is Wrong" seems to be gone. LBE's paper at SSI-11 [Intersection of Science and Law] is gone [ Not Found
The requested URL /~ssi11/SSI-11Papers/P3.pdf was not found on this server. ]

The initial link to the famous 1997 "I am Alan Hale" letter [ The requested URL /~somos/hale.html was not found on this server. ] is gone, although one can still find the letter:

although one wonders how many people pay attention to it in 2018.

Sunday, February 11, 2018

Remyelination and MS

From Stem Cells and Cloning: Advances and Applications » Volume 11

A review on stem cell therapy for multiple sclerosis: special focus on human embryonic stem cells

Published 12 February 2018 Volume 2018:11 Pages 1—11

From within the abstract:

Recent research has shown that cellular therapies hold a potential for CNS repair and may be able to provide protection from inflammatory damage caused after injury. Human embryonic stem cell (hESC) transplantation is one of the promising cell therapies; hESCs play an important role in remyelination and help in preventing demylenation of the axons. In this study, an overview of the current knowledge about the unique properties of hESC and their comparison with other cell therapies has been presented for the treatment of patients with MS.

Note US published application 20180010098

Elsewhere, Gold Nanocrystals May Remyelinate Lesions in Multiple Sclerosis

Recall IPBiz post:
Gold nanoparticles and Curley paper

US 20120190386 and "survey eggs"

From published US patent application 20120190386 :

[0003] At present, when performing a boundary survey for a particular property, survey instruments are utilized to locate the corners of a property owner's lot. The surveyors often mark these corners by driving wooden stakes in the ground.

[0004] When the work is done that necessitated the boundary survey, the wooden stakes are (often) removed.

[0005] Unfortunately for the property owner, if additional work needs to be done, say a few years later, the owner must incur the cost of performing another boundary survey all over again (with potentially varying results).


[0006] The present Invention is conceived as a response to the above-described disadvantages of the conventional art. The present Invention relates to wireless, location-establishing devices (hereafter "Survey Eggs"), that are wireless Global Positioning Satellite (GPS) devices that enable surveyors to permanently locate the boundary points of property lines. Survey Eggs address problems such as having a property owner's boundary surveyed over and over, for thousands of dollars each time the owner, say, renovates their property.

Plagiarizing principal and Shakespeare?

The bottom line for a penalty for plagiarizing a graduation speech: a fine and compulsory attendance at a creative writing course:

The state this month ordered former principal Mark Stenner to pay a $750 fine and take a college-level course on creative writing after he admitted lifting large parts of someone else’s graduation speech.


Elsewhere, some allegations about Shakespeare; see Shakespeare stole from George North? How lucky for George North

On Thursday, literary clickbait broke in the New York Times that Shakespeare, a good poet, had been caught red-handed in some plagiaristic adventuring. (In London, this was gossip hot enough to hit the tabloids.) Using software designed to nab kids who crib from SparkNotes, Dennis McCarthy, a self-taught Shakespearean, found that the language and ideas from an obscure 1576 manuscript pervade some of Shakespeare's most famous plays, including the "Now is the winter of our discontent" soliloquy, from "Richard III."

CBS Sunday Morning on 11 Feb 2018 does crash dummy inventor Sam Alderson

In its almanac feature on February 11, Sunday Morning profiled Samuel W. Alderson, who died February 11, 2005 at age 90.

Alderson's father owned a sheet metal shop, which vocation would play a role in Alderson's development. Alderson studied for a Ph.D. under Oppenheimer and Lawrence at UC/Berkeley, but did not obtain his degree. After a stint at IBM involving a prosthetic arm, Alderson founded his own company in 1952, to create dummies to test the safety of airplane ejection seats. By 1968, he had created the VIP, a dummy for automobile accidents. Alderson later created medical phantoms, designed to measure radiation exposure.

Of patents, see for example, US 2580987 titled " Electrically operated artificial arm for above-the-elbow amputees " and US 3010223 titled "Human equivalent dummy," filed September 2, 1959. [See also "Timeline of United States inventions (1946–91) " at ipfs.]

On September 13, 1899: Henry Bliss becomes the first pedestrian known to be killed by an automobile in North America. Less than ten years later, on September 17, 1908, Thomas Selfridge was the first aircraft fatality. [The world's first road traffic death involving a motor vehicle is alleged to have occurred on August 31, 1869. Irish scientist Mary Ward died when she fell out of her cousins' steam car and was run over by it. ]


The cover story on February 11 was The growing acceptance of autism in the workplace

Moment of Nature: Culebra (Puerto Rico)

**Separately, over at NBC:

The network responded on Saturday by having anchor Carolyn Manno read a statement:

“During our coverage of the Parade of Nations on Friday we said it was notable that Japanese Prime Minister Shinzo Abe made the trip to Korea for the Olympics, “representing Japan, a country which occupied Korea from 1910 to 1945 but every Korean will tell you that Japan is a cultural, technological and economic example that has been so important to their own transformation.” We understand the Korean people were insulted by these comments and we apologize.”

**Separately, Major Garrett did a good job on "Face the Nation" on 11 Feb 2018

See Transcript: OMB Director Mick Mulvaney on "Face the Nation," Feb. 11, 2018

Saturday, February 10, 2018

Jurisdiction at CAFC via Walker Process denied in XITRONIX CORP. v. KLA-TENCOR CORP.

The CAFC noted:

There is nothing unique to patent law about allegations
of false statements. Indeed, in responding to the
court’s order to show cause, the parties both cited portions
of the complaint that focus on fraud and misrepresentation,
not patent law. See, e.g., Xitronix Supp. Br. (Sept.
26, 2017) at 4–5 (“KLA-Tencor affirmatively (and repeatedly)
misrepresented the patentability of the claims it
sought, including making false representations about
what was taught by the relevant prior art.”); KLA Supp.
Br. (Sept. 26, 2017) at 8–9 (“KLA’s prosecution and procurement
of the [’]260 patent was undertaken in bad faith
in order to monopolize the . . . market.”). We acknowledge
that a determination of the alleged misrepresentations to
the PTO will almost certainly require some application of
patent law.


The underlying patent issue in this case, while important
to the parties and necessary for resolution of the
claims, does not present a substantial issue of patent law.
See id. at 263–64. There is no dispute over the validity of
the claims—patent law is only relevant to determine if
KLA intentionally made misrepresentations. Patent
claims will not be invalidated or revived based on the
result of this case. Because Federal Circuit law applies to
substantive questions involving our exclusive jurisdiction,
the fact that at least some Walker Process claims may be
appealed to the regional circuits will not undermine our
uniform body of patent law. See Golan v. Pingel Enter.,
Inc., 310 F.3d 1360, 1368 (Fed. Cir. 2002) (“Federal Circuit
law applies to causes of action within the exclusive
jurisdiction of the Federal Circuit.”); Mars Inc. v. Kabushiki-Kaisha
Nippon Conlux, 24 F.3d 1368, 1371 (Fed.
Cir. 1994) (Deference to regional circuit law “is inappropriate
when an issue involves substantive questions
coming exclusively within our jurisdiction, the disposition
of which would have a direct bearing on the outcome.”
(internal citations and quotation marks omitted)).


Both Nobelpharma and Cipro were decided before the
Supreme Court decided Gunn. To the extent our prior
precedent could be interpreted contrary to Gunn, the
Supreme Court rendered that interpretation invalid.
While the parties argue Gunn is inapplicable because it
concerns district court jurisdiction over state claims, the
indistinguishable statutory language of §§ 1295 and 1338
requires our careful consideration of Gunn in interpreting
our jurisdictional statute. “[W]e have no more authority
to read § 1295(a)(1) as granting the Federal Circuit jurisdiction
over an appeal where the well-pleaded complaint
does not depend on patent law, than to read § 1338(a) as
granting a district court jurisdiction over such a complaint.”
Christianson, 486 U.S. at 814 (citing Pratt v.
Paris Gas Light & Coke Co., 168 U.S. 255, 259 (1897)); see
also id. at 808–09 (noting “linguistic consistency” with the
statute for a district court’s federal question jurisdiction
demands a similar application for the Federal Circuit’s
“arising under” jurisdiction).

Mixed outcome at CAFC in Polaris Indistries v. Arctic Cat

The outcome of Polaris v. Arctic:

For the foregoing reasons, we affirm the Board’s determination
in the 1427 Decision that claims 1–16, 20–33,
and 35 of the ’405 patent are unpatentable as obvious.
We vacate the Board’s obviousness determination as to
claims 17–19, 34, and 36–38 and remand for further
proceedings. We affirm the Board’s determination in the
1428 Decision that Arctic Cat failed to meet its burden of
demonstrating that the claims of the ’405 patent are

Of an assertion of "conclusory"

Relying on these principles, we considered how the
Board should treat undisputed evidence from a patentee
that its product is the invention disclosed in the challenged
claims in PPC Broadband, writing:
When the patentee has presented undisputed evidence
that its product is the invention disclosed in
the challenged claims, it is error for the Board to
find to the contrary without further explanation.
There was no such explanation here. The Board
in its opinions did not explain why the SignalTight
connectors fail to embody the claimed features,
or what claimed features in particular are
missing from the SignalTight connectors.
Here, the Board “decline[d] to accord . . . substantive
weight” to the patentee’s undisputed evidence that its
product is the invention disclosed in certain claims because
it characterized the patentee’s evidence as “conclusory.”
1427 Decision, 2016 WL 498434, at *16. On these
facts, we conclude that the Board erred in failing to credit
Polaris’s undisputed evidence that its RZR vehicles embody
and are coextensive with claims 34 and 36–38 of the
’405 patent.

Friday, February 09, 2018

Merck loses to Amneal at CAFC in mometasone furoate monohydrate [Nasonex] case

This case, arising on appeal of a decision by Judge Robinson in D. Delaware, is strongly related to a case arising in D. New Jersey, and also appealed to the CAFC [2012 U.S. Dist. LEXIS 83414; Merck Sharp & Dohme Corp. v. Apotex Inc., 517 F. App’x 939 (Fed. Cir. 2013). ]

There is a lot to discuss.

For starters, there was an appeal of a discovery ruling.

This included the text

Following two discovery hearings on the issue, the
district court became aware of Amneal’s discovery violation
and acknowledged that ideally Amneal should have
produced samples of the Day 4 and A Batches. The
district court determined, however, that it did not have
enough information at the time to determine whether the
Day 4 and A Batch samples were materially different
from the Day 1 Batch samples. The district court concluded
that it was “not persuaded sitting right here that
mixing [] makes a substantive difference, and if it doesn’t,
then it doesn’t matter that Amneal didn’t give [Merck] a
sample of both [the Day 4 and A Batches] . . . [and] only
gave [Merck the Day 1 Batch].” J.A. 128 at 27:7–12. The
district court did not compel Amneal to produce the
additional samples. Nor did the court postpone trial.
Instead, the district court gave Merck the opportunity to
prove at trial that the Day 4 and A Batch samples were
substantively different than the Day 1 Batch samples and
warned Amneal that it was at risk of incurring costs if
Merck prevailed on the issue.


We start our analysis with the district court’s discovery
ruling. We review the district court’s denial of additional
discovery under regional circuit law. Digeo, Inc. v.
Audible, Inc., 505 F.3d 1362, 1370 (Fed. Cir. 2007). The
Third Circuit will not disturb a denial of additional discovery
absent an abuse of discretion and “a showing of
actual and substantial prejudice.” Anderson v. Wachovia
Mortg. Corp., 621 F.3d 261, 281 (3d Cir. 2010).

The district court’s standing discovery order required
Amneal to “immediately make available to Merck samples
of any further representative commercial batches sent to
the FDA.” J.A. 82 (emphasis added). Amneal, however,
did not produce samples of its Day 4 Batch that it submitted
to the FDA, in violation of the discovery order.

The earlier case in D.N.J. has some interesting text about
Dr. Matzger, who testified in the Amneal case:

Dr. Threlfall found Dr. Matzger's testimony troubling in four ways. Dr. Threlfall stated:

I think he went wrong at four levels: I don't think he applied proper scientific judgment to his testing; I think that the design of his experiments was wrong; the actual performance of experiments leads a lot to be desired; and I think that he analyzed the data incorrectly.
(T. 909, 15-19).
Dr. Threlfall opined that Dr. Matzger had "the mindset of an advocate rather than of a scientist. And in particular, Dr. Matzger [*13] went on the hunt for traces of material, without really applying scientific judgment, . . . ." (T. 910, 10-14). Although Dr. Matzger found that conversion begins to occur as soon as the Apotex ANDA Product is manufactured, Dr. Threlfall's calculation was far different. According to Dr. Threlfall, the "Apotex formulation would be stable against conversion to the monohydrate for around 800 years." (T. 922, 21-24).

Dr. Threlfall was very critical of the shaking or vortexing procedure of Dr. Matzger. Dr. Matzger indicates that the shaking was "gentle." Dr. Threlfall disagreed, he honed in on vortexing.

A. Vortexing is an even more energetic process. I mean it's like creating a mini tornado within the tube. And you can imagine that sort of — smashes all things to pieces, it grinds the nuclei together, it causes them to break and nascent surfaces to form, and nascent surfaces are much more susceptible to change than the intact one would be, because they lost their coatings basically for a moment, and therefore they can change when they wouldn't have otherwise been subjected to change.
(T. 925, 18 through T. 926, 1). Likewise, Threlfall was critical of the washing. He opined that Dr. Matzger [*14] "washed out some of the essential components," (T. 926, 8-10), and that the removal of Avicel by shaking and washing was deleting its "protective coating." (T. 926, 20). Threlfall likened the removal of Avicel to an explorer sent to the Arctic, and then his clothes are "pinched, and you leave him in his underwear." (T. 926, 19-23). Evidently, Threlfall believes that when Dr. Matzger washed and shaked the Apotex product, he was undermining the stability of the compound. (T. 926, 23-24).
In commenting on Dr. Matzger's procedures, Threlfall stated "I would describe this as making scrambled eggs and then claiming you still had the eggs with the shells in the carton." (T. 927, 17-19).

Also of interest are the following statements in the DNJ opinion:

XRPD is the standard method for looking at solid materials and polymorphs. (T. 228, 17-23). 7 XRPD looks at arrangement and characteristic spacings of molecules by measuring the intensity of refracted X-rays at different angles. (T. 230, 10-20). According to Dr. Matzger, XRPD is relatively sensitive and excellent at being able to differentiate between different forms of the same compounds. (T. 228, 17-23). Dr. Cockcroft found that Dr. Matzger did not find peaks due to the lack of intensity; and at best, he found "bumps." (T. 781, 13).


Dr. Cockcroft, 8 an expert for Apotex, noted that x-ray diffraction is covered by a very simple equation "developed by Nobel prize winner William Brack in 1913." The Brack formula relates "to the two-theta values in a diffraction powder" in terms of intensity. (T. 780, 13-21). Based on this formula, the XRPD testing device (diffractometer) was created, and it depicts material on a graph based on the intensity of its peaks. In Dr. Matzger's testing, he used an automatic diffractometer on which he set the scan through the two-theta angles. Once he filled a cell with the prepared sample, the diffractometer then automatically records any peaks based on the intensity on [*19] a graph. (T. 262, 21-25). A peak is produced by a clear signal or intensity. That is, the diffractometer "measures an intensity at each angle . . . so [there] is an intensity versus two-theta peak." (T. 261, 3-6). Often the prepared sample may have some different materials commingled in it during XRPD testing, and the peak may be surrounded by noise (non-peak sound). The signal to noise factor was critical in this case for several reasons.


According to Dr. Cockcroft, the history of the three peaks standard is derived from the work of Mr. Hanawalt. Evidently, in the 1940's, Hanawalt was researching numerous minerals which required him to perform XRPD tests on many minerals. Since there were so many samples, Hanawalt devised a database of XRPD patterns so he could identify each one. In developing a card system to identify each sample, he listed the three most intense peaks of the material on a separate card. This format became known as the Hanawalt Search Index. (T. 788, 4-12). Due to this practice, most scientists still use three peaks to identify a pattern. (T. 788, 4-12).

Lastly, the use of the Brack Formula recognizes [*22] that if a peak occurs at a specific level (say 7.8 degrees) and another peak occurs at a factor of 2 (say 15.6), the second peak is a duplication of the first; and hence it is not considered a unique peak (T. 780, 19-25). Hence, duplication must be considered in analyzing XRPD results.

All four samples were subject to XRPD analysis and recorded on a graph (PTX-451). In each of the samples, Dr. Matzger found "evidence of conversion" with peaks at 7.8 and 11.6 as recorded on figure 2 of the patent. (T. 272, 19-25). 9 On sample 012245, Dr. Matzger found that XRPD showed three peaks "consistent with conversion," namely 7.8, 15.6 and 11.6. (T. 277, 13-19). With regard to the 15.6 peak, it is a factor of 2 of the 7.8 peak. Dr. Matzger noted it "illustrates . . . the problems you can have with overlap because there is a shoulder here that is associated with the 15.6 degree peak as opposed to a "distinct peak as it did in the previous pattern." (T. 278, 11-18) (PTX-480). Despite the fact that it is a shoulder and not a peak, he opined that "its all consistent with conversion." (T. 278, 20). In sample 012245, Dr. Matzger fails to consider the limitation within Brack's formula (see above). Dr. [*23] Cockcroft had indicated that a peak at 7.8 and a peak at 15.6 were duplicative based on the application of the Brack formula. Hence, in sample 012245, there are not three peaks as Dr. Matzger finds, but only two in accordance with the Brack formula. Dr. Matzger never refuted the Brack formula, as such, the limitations within the Brack formula are credible.

For accuracy, the Nobel Prize in Physics 1915 was awarded jointly to Sir William Henry Bragg and William Lawrence Bragg "for their services in the analysis of crystal structure by means of X-rays" The experiment is x-ray diffraction, not refraction.

The Hanawalt method relates to identifying an unknown sample via powder x-ray diffraction. In the 1930's, Hanawalt decided to use the d-values of the three strongest strongest lines in the
diffraction pattern of the unknown (d1, d2, d3) along with their respective respective intensities intensities (I1,I2, I3) to search the powder diffraction diffraction file (PDF) database. There is no database search involved in the Nasonex matter.

Tuesday, February 06, 2018

Elbit loses appeal at CAFC

The outcome

Appellant Elbit Systems of America, LLC (“Elbit”)
sought inter partes review of various claims of Appellee
Thales Visionix, Inc.’s (“Thales”) U.S. Patent No.
6,474,159 (“the ’159 patent”). The U.S. Patent and
Trademark Office’s Patent Trial and Appeal Board
(“PTAB”) issued a final written decision, see Elbit Sys. of
Am., LLC v. Thales Visionix, Inc., No. IPR2015-01095
(P.T.A.B. Oct. 14, 2016) (J.A. 1–25), finding that, inter
alia, Elbit failed to demonstrate by a preponderance of the
evidence that claims 3–5, 13, 24–28, 31, and 34 (“the
Asserted Claims”) of the ’159 patent would have been
obvious over U.S. Patent No. 4,722,601 (“McFarlane”) in
combination with two other prior art references, see
J.A. 2, 4−5.

Elbit appeals. We have jurisdiction pursuant to 28
U.S.C. § 1295(a)(4)(A) (2012). We affirm.

The CAFC noted:

Substantial evidence supports the PTAB’s conclusion
of nonobviousness. It is undisputed that the method of
calculating the “relative angular rate signal” taught in the
’159 patent “is not explicitly disclosed” in the prior art
because the prior art and the Asserted Claims employ
different steps to calculate the orientation or position of a
moving object relative to a moving reference frame.

Of experts:

Elbit’s expert attempts to undermine this testimony
by arguing that the two- and three-step methods are
“mathematically equivalent” and that “there is no practical
difference” between them. J.A. 2034. However, the
PTAB determined that Elbit’s expert’s testimony was
“unsupported” and entitled to “little weight” because he
did not address or account for the recited relative angular
rate signal limitation “anywhere in his opinion.” J.A. 17–
18. “The PTAB [i]s entitled to weigh the credibility of the
witnesses,” Trs. of Columbia Univ. v. Illumina, Inc., 620
F. App’x 916, 922 (Fed. Cir. 2015); see Inwood Labs., Inc.
v. Ives Labs., Inc., 456 U.S. 844, 856 (1982) (“Determining
the weight and credibility of the evidence is the special
province of the trier of fact.”), and, thus, we decline to
disturb these credibility determinations here

Of waiver:

Elbit conceded that it failed to argue that substantial
evidence does not support the PTAB’s decision to credit
Thales’s explanation of the nonobviousness of the twostep
method, see Oral Arg. at 27:30–32 (acknowledging
that they “did not make . . . a legal argument” that the
PTAB’s decision is unsupported by substantial evidence),
which constitutes waiver, see Nan Ya Plastics Corp. v.
United States, 810 F.3d 1333, 1347 (Fed. Cir. 2016) (holding
that failure to present arguments under the operative
legal framework “typically warrants a finding of waiver”)

Calculus appears in footnote 5:

Pursuant to this principle, “as a matter of calculus,
the sum of integrals is equal to the integral of sums.”
J.A. 2144. According to Elbit, this principle dictates that
the same result will be reached whether data is “first
integrated, then subtracted” or “first subtracted, then
integrated,” such that “the order in which these steps are
performed does not matter.” Appellant’s Br. 3. As applied
to the ’159 patent, Elbit contends that the sum of
integrals principle renders the ’159 patent “no more than
a predictable variation of the prior art” and, thus, unpatentable.
Id. at 5 (citation omitted).


“[w]e will not find
legal error based upon an isolated statement stripped
from its context.” Waymo LLC v. Uber Techs., Inc., 870
F.3d 1350, 1361 (Fed. Cir. 2017) (internal quotation
marks and citation omitted). As for whether a PHOSITA
“would understand that the sum of integrals principle
applies to all equations, including navigation equations,”
Appellant’s Br. 37 (capitalization omitted); see id. at 37–
41, Elbit fails to present any evidence supporting this
contention beyond attorney argument, see id. at 37–41,
and “[a]ttorney argument is not evidence” and cannot
rebut other admitted evidence, Icon Health & Fitness, Inc.
v. Strava, Inc., 849 F.3d 1034, 1043 (Fed. Cir. 2017). In
contrast, Thales’s expert testified that a PHOSITA could
have determined that it would be “mathematically inappropriate
or invalid” to apply the principle to the navigation
equations disclosed in the ’159 patent. J.A. 2143. In
sum, substantial evidence supports the PTAB’s determination
that the Asserted Claims would not have been
obvious to a PHOSITA.

Monday, February 05, 2018

MedImmune prevails over Abbvie at CAFC in a Humira case

In a case related to Humica, the CAFC affirmed ED Va:

AbbVie, Inc., and AbbVie Biotechnology Ltd.
(“AbbVie”) filed suit in the Eastern District of Virginia
against MedImmune Limited (“MedImmune”), seeking a
declaratory judgment that U.S. Patent No. 6,248,516 (“the
’516 patent”) is invalid. The district court determined
that it lacked jurisdiction under the Declaratory Judgment
Act, 28 U.S.C. §§ 2201–02, and alternatively that it
would not exercise jurisdiction if it existed, and it granted
MedImmune’s motion to dismiss. We affirm.

Appellant Abbvie won on one point:

The district court erred in holding that it lacked declaratory-judgment
jurisdiction on the basis that there is
no controversy as to infringement of the ’516 patent. (...)

If properly presented, such a contractual dispute
could confer declaratory-judgment jurisdiction. The
Supreme Court has held repeatedly that contractual
disputes can be the subject of a declaratory action. E.g.,
MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 125
(2007) (“All we need determine is whether petitioner has
alleged a contractual dispute.”); Freeport-McMoRan, Inc.
v. K N Energy, Inc., 498 U.S. 426, 426–29 (1991) (per
curiam) (finding federal diversity jurisdiction in declaratory
action concerning breach of contract); Skelly Oil Co.
v. Phillips Petroleum Co., 339 U.S. 667, 674 (1950) (same);
Aetna Life Ins. of Hartford, Conn. v. Haworth, 300 U.S.
227, 242 (1937) (“The dispute relates to legal rights and
obligations arising from the contracts of insurance.”). And
it has held that declaratory-judgment jurisdiction extends
to contractual disputes that turn on issues of patent
infringement and invalidity. MedImmune, 549 U.S. at


AbbVie’s problem is that it did not seek a declaration
of its contractual obligations. Rather, AbbVie’s complaint
only sought a declaration of invalidity with respect to the
’516 patent. And as MedImmune argues and the district
court held, such a declaration would not actually resolve
the parties’ contractual dispute


We concluded that “simply eliminating
one barrier [to resolving the dispute] is sufficient
for declaratory jurisdiction, so long as litigation is also
pending that could eliminate the other barriers.” Id.;
accord Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc.,
527 F.3d 1278, 1288, 1293 (Fed. Cir. 2008).
Here, AbbVie has no other pending litigation that
would conclusively resolve its contractual dispute with
MedImmune. Without taking at least that step, in either
the American or British courts, it cannot establish declaratory-judgment
jurisdiction over the question of invalidity.
Accordingly, the judgment of the district court
dismissing the action without prejudice is affirmed.

Saturday, February 03, 2018

Turnitin's product: Authorship Investigation

The Telegraph talks about "contract cheating," related to students paying third parties to perform
course work, which amounts to a form of plagiarism:

Amid growing concern over “contract cheating”, Turnitin, the largest provider of monitoring software to British universities, will launch a new programme designed to catch out students who pay for professionally written essays.

The new software, named Authorship Investigation, will monitor and learn the writing styles of individual students and flag up content which shows considerable divergence from their previous work.


Friday, February 02, 2018

The CAFC addresses "incorporation by reference" in Paice v. Ford Motor

In 2017-1406 , the CAFC addressed appeal issues related to
final written decisions in six inter
partes review (“IPR”) proceedings, in which the Patent
Trial and Appeal Board (“PTAB”) held certain challenged
claims of U.S. Patent Nos. 7,237,634 (“’634 patent”) and
8,214,097 (“’097 patent”) unpatentable.1

The result in Paice v. Ford Motor:

In particular, we vacate the Board’s obviousness determinations
as they relate to the ’634 patent’s “electrical” claims
and remand for the Board to determine whether those
claims find written description support in the priority
applications and the references incorporated therein. We
affirm the Board’s obviousness determinations as to all
other claims.

Of the written description matter:

For claims to be entitled
to a priority date of an earlier-filed application, the application
must provide adequate written description support
for the later-claimed limitations. Id.; see also Progressive
Cas. Ins. Co. v. Liberty Mut. Ins. Co., 625 F. App’x 552,
558 (Fed. Cir. 2015). Here, Paice asserts that the ’817
application incorporates by reference Severinsky, which
itself provides the requisite written description support.5
The Board rejected that argument, concluding that the
’817 application does not incorporate Severinsky, and that
the electrical claim limitations lack written description
support in the ’817 application standing alone. The
threshold question on appeal, therefore, is whether the
Board’s incorporation ruling is in error. We conclude that
it is.

Incorporation by reference provides “a method for integrating
material from various documents into a host
document[] . . . by citing such material in a manner that
makes clear that the material is effectively part of the
host document as if it were explicitly contained therein.”
Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d
1272, 1282 (Fed. Cir. 2000). “To incorporate material by
reference, the host document must identify with detailed
particularity what specific material it incorporates and
clearly indicate where that material is found in the various
documents.” Id. Whether and to what extent material
has been incorporated by reference is a question of law
that we review de novo. Harari v. Lee, 656 F.3d 1331,
1334 (Fed. Cir. 2011). “[T]he standard of one reasonably
skilled in the art should be used to determine whether the
host document describes the material to be incorporated
by reference with sufficient particularity.” Advanced
Display, 212 F.3d at 1283.

The ’817 application expressly incorporates Severinsky
in the following passage:
This application discloses a number of improvements
over and enhancements to the hybrid
vehicles disclosed in the inventor’s U.S. Pat. No.
5,343,970 (the “’970 patent”) [Severinsky], which is
incorporated herein by this reference. Where differences
are not mentioned, it is to be understood
that the specifics of the vehicle design shown in
the ’970 patent are applicable to the vehicles
shown herein as well.
J.A. 11,174 (emphasis added) (also appearing in the
issued ’634 patent at col. 10, ll. 40–47)

The issue:

The Board reached a contrary conclusion, however, by
relying on the subsequent sentence in the passage, which
states: “Where differences are not mentioned, it is to be
understood that the specifics of the vehicle design shown
in the ’970 patent are applicable to the vehicles shown
herein as well.” According to the Board, this sentence
limits incorporation to only those disclosures in Severinsky
that are not different from disclosures in the ’817
application. Because the Board found differences between
Severinsky’s disclosures related to the electrical limitations
and the ’817 application’s corresponding disclosures,
the Board determined that Severinsky’s disclosures are
not incorporated into the ’817 application. The Board’s
conclusion is incorrect.

How the CAFC reasoned that PTAB's interpretation was incorrect:

This statement provides an expedient way for
the applicant to describe the invention vis-à-vis Severinsky
without describing every feature of Severinsky that is
subsumed within the invention.
The sentence has no bearing, however, on the extent
of incorporation. It refers only to the applicability of
certain features of Severinsky’s invention to the ’817
application’s purportedly new and improved hybrid vehicle,
rather than to which textual portions of the Severinsky
document are incorporated in the ’817 application.
The applicability of a document’s disclosed features and
the incorporation of the document itself are distinct
concepts, and one does not imply the other. See Modine
Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1553
(Fed. Cir. 1996) (“[I]ncorporation by reference does not
convert the invention of the incorporated patent into the
invention of the host patent.”); see also Fifth Generation
Comput. Corp. v. Int’l Bus. Machs. Corp., 416 F. App’x 74,
80 (Fed. Cir. 2011) (agreeing that certain prior art references
were incorporated into the host patent but disagreeing
“that every concept of the prior inventions is
necessarily imported into every claim of the later patent”);
S. Clay Prods., Inc. v. United Catalysts, Inc., 43 F. App’x
379, 383–84 (Fed. Cir. 2002) (finding incorporation notwithstanding
the host patent’s criticism of the incorporated
patent’s invention).

In addition to a general criticism of PTAB's interpretation of
incorporation by reference, the CAFC noted:

Even if the second sentence in the ’817 application’s
incorporation clause could be read as a narrow incorporation,
our holding in Harari v. Lee would foreclose the
Board’s conclusion. The patent application at issue in
Harari contained two incorporation clauses. In the first
clause, the application stated that “[t]he disclosures” of
two prior art applications “are hereby incorporate[d] by
reference.” Harari, 656 F.3d at 1335. In the second
clause, the application stated that only the “[r]elevant
portions” of the disclosures are incorporated. Id. We held
that the “broad and unequivocal language” of the first
clause “incorporates the entire disclosures of the two
applications,” and that the second clause’s narrower
language did not diminish the scope of incorporation.

Of Ford's argument on Harari, the CAFC noted

At oral argument before this court, Ford sought to distinguish
Harari on grounds that, in that case, there were
two incorporation clauses separated by several paragraphs
of text, in contrast to this case, where the two
sentences in dispute appear in a single incorporation
clause. Oral Arg. at 26:45–27:12, Paice LLC v. Ford
Motor Co. (No. 2017-1387), http://oralarguments.cafc. According
to Ford, the “juxtaposition of the two sentences back-toback”
in the ’817 application would inform a skilled artisan
that differences are not incorporated therein. Id. at
Ford’s purported distinction of Harari on the basis
that the incorporation clauses at issue were separated by
text is not persuasive. We said nothing in Harari about
the proximity of the incorporation clauses, predicating our
holding instead on the “broad and unequivocal language”
of the first incorporation clause, and notwithstanding that
the incorporation “occurred during a discussion of” particular
teachings. And, while we agree with Ford that
Harari commands that incorporation clauses be read in
context, we disagree that the sentences at issue here limit
the scope of incorporation when so read. The ’817 application’s
incorporation passage provides no nexus between
the “differences” referenced in the second sentence and
the incorporation referenced in the first sentence, in
contrast to cases in which we have found incorporation to
be limited.


Ford also asserted for the first time at oral argument
that our decisions in Callaway Golf Co. v. Acushnet Co.,
576 F.3d 1331 (Fed. Cir. 2009), and Husky Injection
Molding Systems Ltd. v. Athena Automation Ltd., 838
F.3d 1236 (Fed. Cir. 2016), support the Board’s ruling.
But, in both cases, we found that the incorporation clauses
at issue did in fact incorporate the relevant passages of
the prior art into the host documents. And, in any event,
those cases are inapposite

Of the remand

The written description inquiry is a highly factintensive
one that “requires fact findings this court is not
permitted to make.” Bilstad v. Wakalopulos, 386 F.3d
1116, 1126 (Fed. Cir. 2004); Union Oil Co. of Cal. v. Atl.
Richfield Co., 208 F.3d 989, 1000 (Fed. Cir. 2000) (noting
that “written description questions are intensely factual,
and should be dealt with on a case-by-case basis, without
the application of wooden rules”). We therefore remand
for the Board to determine in the first instance whether
the ’817 application, with Severinsky incorporated therein,
supplies the requisite written description support for
the ’634 patent’s electrical claims. In other words, the
Board must consider Severinsky for that purpose on