Thursday, January 29, 2015

Celgard, LG, Apple and lithium-ion batteries; Rule 1.7(a)

Related to a post at PatentlyO titled Federal Circuit Grants Motion to Disqualify Jones Day on Appeal, note discussion of previous action in the case from

Korea Times:
--

Celgard was one of LG partners by supplying base film used in separators - one of key technologies used in batteries since 2005.
But LG Chem terminated the contract with Celgard in July of last year in line with LG Chem's move to diversify its materials-sourcing channels.
"For materials suppliers such as Celgard, partnership with major battery manufacturers is crucial. I think Celgard's ultimate purpose of the legal fight reflects its underlying hope to resume its business tie-up with LG," said an executive at LG Chem's  one supplier in Korea.


-- 

Celgard's action against LG relates to United States Patent No. 6,432,586.

The post on PatentlyO related to an issue with Jones Day representing both Celgard and Apple  ; from the case

--
Apple Inc. states that the Jones Day law firm’s representation
of Celgard LLC in this infringement suit
against their lithium battery supplier, LG Chem., Ltd.,
has made it more difficult for Jones Day to effectively
represent Apple in unrelated ongoing legal matters.


(...)

The complaint named only LG Chem and its affiliate companies,
not its customers [that is, Apple was not named].


(...)

After Jones Day rejected Apple’s repeated requests to
withdraw, Apple moved for leave to intervene in this
matter for purposes of seeking to disqualify Jones Day.
Apple asserts that the preliminary injunction covers the
custom batteries LG Chem provides for Apple’s products
and that Jones Day currently represents Apple in several
ongoing unrelated commercial litigation matters.

--

 The CAFC noted

--
We addressed similar circumstances involving the
same conflict rule, albeit from a different jurisdiction, in
Freedom Wireless, Inc. v. Boston Commc’ns Group, Inc.,
Nos. 2006-1020 et al., 2006 WL 8071423 (Fed. Cir. Mar.
20, 2006). There, we agreed that counsel for plaintiff
should be disqualified from seeking to enjoin a wireless
service technology provider based on the firm’s ongoing
relationship with a customer of the provider because any
“[a]dvocacy by counsel for [plaintiff in support of] . . . the
injunction will adversely affect [customer]’s interest in

being free of the bar of the injunction.” Id. at *2. This
court added:
Here, counsel has asserted a position that an
injunction obtained on behalf of one client .
. . should limit the activity of another client .
. . . In this situation, a clear and direct conflict
of interest has arisen.
Id. at *3.


(...)
As evidenced by Jones Day’s attempts to
limit the nature of the representation, Jones Day and
Celgard clearly knew the potential for conflict here yet
elected to continue with the representation.


--

OriginOil to work with Idaho National Laboratory?

From renewableenergymagazine:

--

Disinfection capabilities provided in the form of OriginOil’s Electro Water Separation technology (EWS) may help to create giant open-air ponds for large-scale algal biofuels production.
EWS is a high speed, chemical-free process that has been developed by the company to clean up large quantities of water. OriginOil and INL have submitted a proposal, in response to a Funding Opportunity Announcement (FOA), entitled “Targeted Algal Biofuels and Bioproducts” (TABB) which seeks alternative approaches to solving two of the key problems facing the commercialisation of algal biofuels – high cost of production and low yield.
 “The proposed work scope complements current Department-funded work at INL, which focuses on the development of productive, stable polycultures” said Deborah T Newby, Ph.D., INL Senior Staff Scientist and Algal Biofuels Lead. “Specifically, this proposed research will facilitate testing to advance the understanding of using algae in developing sustainable fuels.”

--

Revolving door between Google and the White House?

From a letter by Ken Blackwell:

--

Interestingly, the number one corporate cheerleader for patent reform has been Google. Let’s not forget how close the Obama administration is to Google. There has practically been a revolving door between the company and the White House. If you hate crony capitalism, then you should be worried about the administration and Congress acting so aggressively to overhaul the patent system to advance the financial interests of Google and others.
Strong patent protections are one of the key economic concepts that distinguishes us from nations like China, where Intellectual Property theft is rampant. Why would we support legislation that emulates their model? We should be protecting our inventors from theft and ensuring American innovation is on the cutting edge, not undermining property rights and surrendering our one key advantage to the Chinese.
A number of leading conservative organizations and legal scholars have expressed grave concerns about the consequences of this legislation. It makes no sense for conservatives to support legislation that stifles innovation, weakens property rights, surrenders our advantage to China and rewards Obama’s leading corporate supporters.

--

Wednesday, January 28, 2015

On the value of using things




A Supreme Court justice quoted Napolean to the effect that the tools belong to the one who uses them.  On a related note, a picture on the wall of an elementary school:


--


--Nearby: 


Is the "inter partes review" of the AIA constitutional?

In a post titled A Constitutional Challenge to Inter Partes Review   , PatentlyO
talks about a brief by Ned Heller asking the CAFC to find the inter partes review component of the AIA unconstitutional for violation of the Seventh Amendment right to a jury trial.  IPBiz recalls the constitutional challenge to the copyright law mounted in Eldred v. Ashcroft.  CJ Rehnquist noted the grant to Congress was general and Congress was "free to run with it in many respects." 

If one looks on the internet for a discussion of 7th Amendment rights, one may find something like

--

Application of the 7th Amendment

When does the 7th amendment apply? There are four criteria for you to be able to have a trial heard by a jury under the 7th amendment.
  1. First, your claim must be a civil claim as opposed to a criminal claim. This essentially means you are seeking money to compensate your loss from the person you are suing.
  2. Second, the claim must be based on federal law and be in a federal court. The 7th amendment, believe it or not, does not apply in state courts. Some states, however, have adopted the right to a jury in civil cases.
  3. Third, the lawsuit must be more than $20. Interestingly, $20 was a decent amount of money when the Framers wrote the Constitution. Nonetheless, despite the depreciated value of $20, it is still the threshold used to decide if a trial by jury is allowed.
  4. Finally, the lawsuit has to be a claim for which the English common law of 1791 would have allowed a jury trial. If the English common law of 1791 would not let your claim go to trial, then it cannot go to trial by jury under the Constitution.

--link:  http://education-portal.com/academy/lesson/the-7th-amendment-definition-summary-court-cases.html

From the Markman case, we know that the 7th Amendment applies to patent infringement case; from Wikipedia:  The 7th Amendment guarantees the right to a jury trial in patent infringement cases. The 7th Amendment preserves the right to jury trial as it existed in 1791. There is no dispute that infringement cases today must be tried by a jury as their predecessors were in 1791.

But, is there an English common law counterpart to "inter partes review" which existed in 1791 and which allowed trial by jury?  

Judge Pauline Newman wrote in Patlex v. Mossinghoff, 758 F.2d 594 (Fed. Cir. 1985):

--
In contrast with the private rights at issue in Northern Pipeline, the grant of a valid patent is primarily a public concern. Validity often is brought into question in disputes between private parties, but the threshold question usually is whether the PTO, under the authority assigned to it by Congress, properly granted the patent. At issue is a right that can only be conferred by the government. See Crowell v. Benson, 285 U.S. at 50, 52 S.Ct. at 292. Thus we find no constitutional infirmity, under the analysis suggested by Northern Pipeline, in patent reexamination by the PTO. 

The holding of McCormick Harvesting may also be distinguished, in view of Congressional intent to provide a separate procedure for reexamination while preserving the reissue practice. The purpose of reissuance of patents is to enable correction of errors made by the inventor, at the initiative of the inventor. The reexamination statute's purpose is to correct errors made by the government, to remedy defective governmental (not private) action, and if need be to remove patents that should never have been granted. We do not read McCormick Harvesting as forbidding Congress to authorize reexamination to correct governmental mistakes, even against the will of the patent owner. A defectively examined and therefore erroneously granted patent must yield to the reasonable Congressional purpose of facilitating the correction of governmental mistakes. This Congressional purpose is presumptively correct, and we find that it carries no insult to the Seventh Amendment and Article III.

--

Within Crowell, one finds the text:

--

As the claims which are subject to the provisions of the Act are governed by the maritime law as established by the Congress and are within the admiralty jurisdiction, the objection raised by the respondent's pleading as to the right to a trial by jury under the Seventh Amendment is unavailing ( Waring v. Clarke, 5 How. 441, 459, 460 (1847))
--

As a footnote, Mr. Reverdy Johnson represented the appellants (Waring et al.) in Waring v. Clarke.  [Johnson defended Sandford of the Dred Scott case; as a US Senator, he was a pall bearer for Abraham Lincoln.]

From the earlier post on IPBiz Bilski: which elements from Eldred will return?
  
:
--

Further to the IPBiz post titled
On horse-training methods and Bilski oral argument
, one recalls the exchange between Chief Justice Rehnquist and Professor Lessig in Eldred v. Ashcroft:

MR. LESSIG: Well, if it flies in the face of what the Framers had in mind, then the question is, is there a way of interpreting their words that gives effect to what they had in mind, and the answer is yes.

CHIEF JUSTICE REHNQUIST: Well, you know, certainly what is happening in the country today in the way of congressional -- under the Commerce Clause is totally different than what the Framers had in mind, but we've never felt that that was the criterion. What the Framers thought of, there weren't steamboats, there weren't railroads.

MR. LESSIG: That's right.

CHIEF JUSTICE REHNQUIST: We've said there was a general grant, and that Congress was free to run with it in many respects.


Another interesting exchange:

MR. LESSIG: That's right. That's the important hurdle, and we'd like to jump that first, but the other ones, Justice, you're right, in 1831 and in 1909 Congress extended terms in a way that is inconsistent with the strongest form of the test that we have advanced. Those extensions, however, were never challenged in any court and certainly not considered by this Court.

CHIEF JUSTICE REHNQUIST: Well, doesn't that itself mean something, Mr. Lessig? The fact that they were never challenged, perhaps most people, and perhaps everybody felt there was no basis for challenging them.

MR. LESSIG: Well, Mr. Chief Justice, it's absolutely true that this case is here because of a fundamentally important changed circumstance that makes the Framers' limitations on the Copyright Clause much more significant. This is the first time I can remember where this Court has been pointed to changed circumstances as a reason to reaffirm the Framers' values, because for most of this period, Mr. Chief Justice, the only people who were regulated by copyright law under the Copyright Act would have been [*4] commercial publishers, primarily, and now for the first time the scope of this exclusive right has expanded because of the changed technology of the Internet to reach an extraordinarily broad range of creativity that never would have been imagined before.

Now, it's not the case that the earlier extensions were not questioned on constitutional grounds. In fact, Melville Nimmer, in the consideration of the 1976 act, suggested they were plainly under --

CHIEF JUSTICE REHNQUIST: Well, I'm talking about court challenges, not academic challenges.


IPBiz notes the existence of Lawrence Lessig's article, "How I Lost the Big One," [ Legal Aff., Mar./Apr. 2004] concerning the outcome of Eldred v. Ashcroft, which includes the text:

--

"Clear error" review under Rule 52; thinking back to KSR

With the discussion about "clear error" review of extrinsic evidence in fact-finding underlying claim construction, one recalls an aspect of KSR v. Teleflex.
From the 2009 IPBiz post KSR v. Teleflex: story-telling is nice, but...   

--
IPBiz agrees that there was a lot going on in KSR that most people do not discuss. First, it was a non-precedential case of the CAFC, not the sort of thing that the Supreme Court typically reviews. Second, the substantive issue of obviousness was not even at issue in the case; the CAFC did not hold that the claims were, or were not, obvious. Third, there was a lot of discussion of expert testimony, with the CAFC believing more in patent applicant's expert and the Supreme Court going more with the other side's expert. The facts were pretty clear. Story telling was the issue.

Separately, first formed opinions are tough to break. The Supreme Court went into KSR with some strong beliefs (eg gobbleygook) that may, or may not, have existed by the end of the case. Along this line, compare Justice Scalia's discussion of text in the Hatch-Waxman Act in Merck v. Integra to Justice Scalia's earlier opinion.

--

Separately, from a comment by Mr. Lynch at PatentlylO

--
 Adding some number of cents to Lawrence Ebert’s very early comments on the Teva case, I would like to carry forward Mr. Ebert’s observation that the district court opinion did not call out the “finding of fact” that SCOTUS said was entitled to the “clearly erroneous” protections of Rule 52(a)(6).
The Supremes focused on the provisions of Rule 52(a)(6) which establishes that findings of fact by the District Court must not be set aside unless clearly erroneous. True enough, but what is the character of the findings that obtain this “clear error” insulation on appeal? Rule 52(a)(1) says that these are findings that the District Court must make specially “in an action tried on the facts without a jury.” So findings of fact entitled to the clear error insulation of Rule 52(a)(6) are findings made after a case has been “tried.” In the Teva case, it seems the expert testimony that the district court credited was adduced at a non-jury trial, not in any Markman proceeding.
District court judges are seemingly not fond of the entire Markman procedure (at least in part because of the perception that the Federal Circuit’s de novo review rule denigrated the difficult and time consuming efforts that the lower court was required to expend). As partial result, Markman claim construction procedures have not been uniform, and have often been involved a pretrial proceeding involving submission of briefs (with declarations) and argument. Such procedures hardly qualify a “trial” needed to support any fact findings essential to claim construction that are not based on intrinsic evidence.
Messrs. Rich and Williams noted that the Teva decision “encourages parties to submit extrinsic evidence.” But can such evidence to support claim construction can be submitted in a proceeding other than a trial now that such factual underpinnings must march to the cadence of Rule 52. In jury cases, this suggests a preliminary non-jury trial to resolve such contested facts, or alternatively a series of sessions during trial outside the presence of the jury. (Let us pass the issue of whether the factual determination of “the underpinnings of claim construction” ventures into the province of the jury. For the moment, we shall assume that such factual determinations are exclusively for the judge, like factual determinations made, for example, in assessing the admissibility of evidence. This is another fertile area for litigators to plow.) In non-jury cases, judges would be hard-pressed to yield to the demand for two trials, so the claim construction might not be established in advance of the liability trial.
This could yield procedural environment where the claim construction exercise is increasingly not undertaken until trial, and the parties do not have a firm understanding of the district court’s view of what the claim means until deep into the trial or as late as delivery of the jury charge. Some judges have adopted this latter practice.
My personal belief has always been “evidence trumps experts,” and opportunistic counsel will look for extrinsic evidence beyond precooked expert opinions to affect claim construction. So I wonder if the Teva lawyers ever inquired how Sandoz scientists manifested an understanding of “molecular weight” in their everyday work involving compounds like Copaxone or looked for other extrinsic evidence as to what was the accepted mode of calculating molecular weight of that material. These observations support a conclusion that a trial within a trial could be increasingly brewing in future Markman procedures.
I agree with Prof. Ghosh’s comment that the Teva decision will “open the floodgates for experimentation by advocates and judges.” My take is that advocates will be seeking advantage and judges striving to uncomplicate an already taxing Markman process. In the interim, the Federal Circuit, which does not always demonstrate a masterly command of the rules and consequences of evidence, is going to be feel a bit strait-jacketed in its review of Markman rulings
--

Tuesday, January 27, 2015

US Patent 8,940,520 to Pond Biofuels


--
United States Patent8,940,520
Martin ,   et al.January 27, 2015
--

First claim

--
1. A process of growing a phototrophic biomass in a reaction zone, wherein the reaction zone includes an operative reaction mixture, wherein the operative reaction mixture includes the phototrophic biomass disposed in an aqueous medium, comprising: producing gaseous exhaust material with a gaseous exhaust material producing process that is disposed upstream of the reaction zone, wherein the gaseous exhaust material includes carbon dioxide; discharging the gaseous exhaust material from the gaseous exhaust material producing process; providing a sensor upstream of the reaction zone; sensing upstream of the reaction zone, a characteristic of the discharged gaseous exhaust material with the sensor, for establishing a first molar rate of supply of carbon dioxide within the discharged gaseous exhaust material; supplying the discharged gaseous exhaust material to the reaction zone such that the carbon dioxide in the gaseous exhaust material is received by the phototrophic biomass so as to provide a carbon dioxide-enriched phototrophic biomass in the aqueous medium; exposing the carbon dioxide-enriched phototrophic biomass disposed in the aqueous medium to photosynthetically active light radiation so as to effect photosynthesis; and modulating at least one input to the reaction zone when a second molar rate of supply of carbon dioxide is established based on sensing the characteristic of the gaseous exhaust material with the sensor, wherein the second molar rate of supply of carbon dioxide is different from the first molar rate of supply of carbon dioxide, and wherein the modulating of at least one input includes at least one of: (a) effecting or eliminating supply of, or modulating the intensity of, the photosynthetically active light radiation to which at least a fraction of the carbon dioxide-enriched phototrophic biomass is exposed; and (b) effecting, modulating, or eliminating the molar rate of supply, or commencing supply, of a nutrient supply to the reaction zone. 
--

CAFC affirms PTAB in Plas-Pak


From Plas-Pak as to obviousness:

--

Where “a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield pre- dictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). However, combinations that change the “basic principles under which the [prior art] was designed to operate,” In re Ratti, 270 F.2d 810, 813 (CCPA 1959), or that render the prior art “inoperable for its intended purpose,” In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984), may fail to support a conclusion of obviousness. 

--

And as to specifics:

--


” Such a change in a reference’s “principle of operation” is unlikely to motivate a person of ordinary skill to pursue a combination with that reference. In re Mouttet, 686 F.3d 1322; In re Ratti, 270 F.2d 810. Accord- ingly, the Board did not err in concluding that claims 1– 15 would not have been obvious over Fukuta in view of Morris.
--

As to "intended purpose"

--


We agree with Sulzer that the Board’s definition of Jacobsen’s “intended purpose” and the Board’s finding that adding Hunter’s spray nozzle would render Jacobsen “inoperable for its intended purpose” are supported by substantial evidence. 
--

The conclusion:

--
 We have considered the remaining arguments and
find them unpersuasive. Because the Board did not err in
finding that the prior art combinations would either alter
Fukuta’s “principle of operation” or render Jacobsen
“inoperable for its intended purpose,” we affirm the
Board’s decision to decline to make the proposed obviousness
rejections of claims 1–15 of the ’384 patent.

--

Teva, Sandoz each act after Supreme Court decision


The ScotusBlog discusses current timing issues in Teva v. Sandoz:

--
Specifically, Sandoz and three other generics on Friday asked the Court not to wait the usual twenty-five days to put its new decision into effect, saying that each day is important with the last remaining Teva patent on Copaxone due to expire next September 1.   Any delay, those firms said in their application, may mean that the case loses any remaining significance on the question of when the generics could enter the market with their version of Copaxone.
For its part, Teva told the Court in its response Monday that it has already asked a federal trial judge in New York City to put back into effect a formal court order that bars the generic firms from putting their substitute on the market until after the remaining Teva patent has expired.  Teva argued that the Justices should not issue their implementing order until after the New York judge has a chance to act on the plea to restore the marketing injunction order.  If the case returns swiftly to the U.S. Court of Appeals for the Federal Circuit, the New York judge would lose jurisdiction to put that order back into effect, Teva contended.  The generics, the company added, will not be harmed, because they still have not obtained government clearance to sell their generic versions.

--

One interesting aspect of the review requested by the Supreme Court is that Teva's argument about Mp was both during prosecution (intrinsic) and in litigation (extrinsic).  Which standard applies to the  level of deference?

*also, from an article in the National Law Review

--

So the Fed. Cir. could at once give “deference” to the technical definition arrived at by the district court, while finding that the claim construction was erroneous. To use Justice Thomas’ framework, since Google lost, it needs to be able to argue on appeal that the Fed. Cir. did not give proper deference to the extrinsic technical definition applied by the district court. But the Fed. Cir. reminded us that the intrinsic evidence often trumps the extrinsic evidence. (“However extrinsic evidence may be less reliable than intrinsic evidence.”) While the “point” of the holding in Teva is to reduce the “zone of uncertainty” involved in claim construction, the Fed. Cir. will always be free to access the specification and the prosecution history of the patent in suit, and to review whether or not the district court’s legal analysis of the intrinsic evidence was facially deficient, no matter what facts were “found”. In Vederi, the outcome turned on the definition — or lack thereof — of a single word. I don’t think that the Fed. Cir. will find it overly difficult to sidestep the necessarily extrinsic “evidentiary underpinnings” of claim construction.
--

EPO does infomercial in New Scientist

From an article by Dai George in New Scientist:
--


The interview was produced by New Scientist in conjunction with the European Patent Office, which paid for it to be produced.
Innovation often starts with a "light bulb moment". But after that it's up to a team of sharp-eyed patent examiners to figure out whether a new invention deserves to be protected with a patent. Dai George asks patent examinerLaura Smith-Hewitt what it's like to work at the European Patent Office (EPO).
--

Monday, January 26, 2015

Gevo v. Butamax back to CAFC

The  Supreme Court has sent the Gevo/Butamax case back to the CAFC in view of Teva v. Sandoz:

--

The other two cases on which the high court acted were Gevo Inc v. Butamax Advanced Fuels LLC and Lighting Ballast Control LLC v. Universal Lighting Technologies Inc, U.S. Supreme Court, Nos 13-1286 and 13-1536.
--

Fro Reuters

University of Maryland does patent law

From. CBSBaltimore via AP:

--
BALTIMORE (AP) — The University of Maryland Francis King Carey School of Law has expanded its new master of science in law program to include specializations in patent law and cybersecurity, bringing the number of options to five.
The master’s degree program, set to launch this fall, is designed to give non-lawyer professionals a deeper understanding of the way law and policy impact their day-to-day work.


--

Sunday, January 25, 2015

Patent litigation down

A statement in The Hill suggests patent litigation is significantly down:


Other Senate Democrats, however, are echoing warnings from biotechnology, research and other companies that the patent landscape has fundamentally changed, following recent Supreme Court decisions and past legislative changes just now taking effect. In a letter organized by the Innovation Alliance last week, a group of 240 businesses noted patent litigation has dropped 40 percent from 2013 to 2014. 
"I agree we need to find a way of working together to clamp down on abuses. But I would urge a little caution as we consider any changes,"  said Sen. Chris Coons (D-Del.), another member of the Judiciary Committee.

60 Minutes on January 25, 2015

Scott Pelley interviews the Republican Congressiinal leaders.  Boehner hit on Obama-care.  Not looking good for free community college or increased minimum wage.  Boehner points out highway trust fund issues.  Boehner is very concerned about the Iranians.  Enhanced sanctions if deal not reached.  Bibi Netanyahu invite as a brush-back pitch to Obama?   Use of force against ISIS?  Whose boots on the ground against Isis?  Obama will veto the immigration bill?   Obama's job approval is 44% but Congress's is 15%.  Pelley asks:  can you bring the Tea Party in line?
McConnell alluded to the debates between Jefferson and Adams?

Bill Whittaker on "the Cleveland Division".  Chief Calvin Williams.   He assumed command in February.   Tamir Rice.  DoJ :  us against them mentality.  Robert J. Clark:  policeman shot.
Murder rate higher in zCleveland than in Chicago.   How Cleveland police deal with the mentally ill.
450 officers out of 900 are trained for such.  

CBS Sunday Morning on January 25, 2015

The show began with a violin playing.  Charles Osgood introduced the stories.
The cover story is by Tracy Smith on speaking out on sexual assault.  Second, Dean Reynolds on string theory z(violins).  Third,a Serenade Alschul on the barefoot contessa.   Fourth, Lee Cowan on Penn and Teller.  Mark Phillips on Stonehenge.   Anthony Mason.  Faith Salie.  Steve Hartman.
Headlines.  ISIS beheads Japanese journalist.  Holly Williams.  Obama in India.   Fighting in eastern Ukraine.  Ernie Banks dead.  Joe a Franklin dead.  Bill Belichek press conference on deflated footballs.  Weather.  Colder in northeast.

Tracy Smith did the cover story on victims of sexual assault.  Grace Brown.  18-24 most likely targets.  "It's on us." campaign.  Put up systems that allow justice to occur.  Sarah Gilcreest.  Enforcement under Title IX.  Valerie Simmons.  Andrew Miltonberg.

Almanac.  Jan. 25, 2890.  Nellie Bly goes round the world, starting in NJ.  NY World.  Takes 72 days.
1956 movie wth David Niven.

Friday, January 23, 2015

Cyanobacteria in space

From press zoom:

--
MELiSSA (Micro-Ecological Life Support System Alternative) is investigating ways of producing food, water and oxygen on long manned space missions with limited supplies. The goal is to support the human exploration of the Solar System, as well as meeting pressing challenges on Earth. 


--

What does the CAFC do to establish clear error? Or is clear error review needed here?


As  to the Supreme Court directions in Teva v. Sandoz, the CAFC must review the factual underpinnings of the district court decision for clear error..  Or does it?


PatentDocs (Kevin Noonan) described some of the issues in the Supreme Court requirements for review:


--

Now, in its Teva decision the Court has decided that appellate review of claim construction is limited by Federal Rule of Civil Procedure 52(a)(6), wherein Federal Circuit review of "subsidiary" facts "underpinning" claim construction must be reviewed with deference to the district court and overturned only where there is clear error in the court's decisions:
In cases where those subsidiary facts are in dispute, courts will need to make subsidiary factual findings about that ex­trinsic evidence.  These are the "evidentiary underpin­nings" of claim construction that we discussed inMarkman, and this subsidiary factfinding must be reviewed for clear error on appeal.
This will arise when "the district court will need to look beyond the patent's intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the rele­vant art during the relevant time period."  See, e.g., Seymour v. Osborne, 11 Wall. 516, 546 (1871).
Such deference is not absolute, however:  the opinion states that where the district court's construction is limited to the intrinsic evidence, i.e., the "plain meaning" of the claim language, the specification and ("when in evidence") the history of prosecution in the Patent and Trademark Office, then the appellate court's review can be plenary and give no deference to the district court's construction.  It is only when there is "extrinsic" evidence (which, up until now has been disfavored; Philips v. AWH) must the Federal Circuit tread lightly on what was decided below and adhere to the deferential standard of clear error.


--

An issue is that Teva made the same argument about Mp to the examiner during prosecution (intrinsic) AND to the court via expert witness Dr. Grant (extrinsic).  Does the fact that the same argument made in prosecution was made a second time elevate the standard of review from plenary to clear error?  The argument by Teva is false because Mp is a mode and is not a species of "average molecular weight."  The invocation of Mp does not offer written description support for the claim element "average molecular weight."

Of the former argument during prosecution:


During prosecution of the '539 patent, the Examiner rejected [] pending claims as indefinite, stating that "the term 'average molecular weight' . . . is indefinite since its method of measurement is not specified, i.e. [Mn], [Mw] . . . etc." J.A. 3245. Teva stated in its response that "[o]ne of ordinary skill in the art, upon reviewing the specification, would understand that 'average molecular weight' refers to the molecular weight at the peak of the molecular weight distribution curve shown in Figure 1," i.e., Mp. J.A. 3258. The claims were allowed. During prosecution of the '847 patent, the Examiner made an analogous rejection over the same claim term, stating that "the term 'average' molecular weight . . . is meaningless as a limitation without specifying its basis, e.g., [Mw], [Mn], etc." J.A. 3220. Teva overcame the rejection by responding that "[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight," i.e., Mw. J.A. 3229. The only basis upon which the Examiner could have agreed that the'539 patent claims were not indefinite was that "molecular weight" means Mp. In contrast, the only basis for the Examiner's withdrawal of the indefiniteness rejection of the '847 patent claims  [] was that the same term means Mw. Teva's two definitions cannot be reconciled.



The argument as to the '847 was later acknowledged to be false.

Of the '539 argument, the CAfC noted that Mp was not an "average molecular weight."

Is this observation sufficient to establish that Dr. Grant's assertion, as an expert witness credited by the district court,  is clearly erroneous?  If not so, what fact-finding must the CAFC engage to establish the error of Dr. Grant?

Thursday, January 22, 2015

"No patent practitioner can ever know"?

Kevin Noonan at PatentDocs has an interesting post on Teva v. Sandoz which includes the text:



The moral:  no patent practitioner can ever know what terms must be expressly defined, and the only alternative is to accept a "zone of uncertainty" regarding the scope or validity of patent claims or to burden every specification withevery definition of every term that could possibly be relevant in future.  In short, both an impractical and impossible standard to hold either patents or patent practitioners to satisfy.



The facts of Teva v. Sandoz do not illustrate this point.   The critical parameter in the Teva invention WAS the molecular weight range.  It was foreseeable that claims to a particular molecular weight range would be of commercial significance.  It was equally foreseeable that establishing related claim elements to define the range would be important.

Yet, Teva had claims speaking of average molecular weight without defining how average molecular weight is measured.  The deficiency became apparent in prosecution.  Teva reached for a straw by invoking peak average molecular weight (Mp), which is a mode, not an average.  Mp is not a species of the genus "average molecular weight."

*****
link:  http://www.patentdocs.org/2015/01/whats-next-some-consequences-of-the-teva-v-sandoz-decision.html
*****
The term "average molecular weight" was first used during the prosecution of the '539 patent. Teva stated it sought claims to "[a] copolymer-1 composition comprising a mixture of polypeptides composed of glutamic acid, lysine, alanine and tyrosine, wherein the mixture has an average molecular weight of about 4 to about 9 kilodaltons." (Crystal Decl. Ex. 13 at TEV000304783 (Teva v. Mylan claim construction).) The patent examiner rejected the claims directed to "average molecular weight" as indefinite on the basis that the PTO could not determine what average was being claimed:

Are the findings of fact in Teva v. Sandoz clearly erroneous?


The  so-called "peak average molecular weight" mentioned in Teva v. Sandoz is more accurately termed the mode of the distribution.  It is not an average.  This is a major issue of fact in the case.
[As  LBE said at PatentlyO:  As to an issue identified by the CAFC, the claim talks about an “average” molecular weight, but Mp is a mode, not an average. Mp is not a species within the genus of average molecular weights. This is a clearly erroneous finding of fact. Just because the examiner was fooled does not remedy the error.]

What exactly are the findings of fact which the CAFC needs to review?  The Supreme Court dissent might suggest there aren't any.


As to the recently-decided Supreme Court case in Teva v. Sandoz, 2015 U.S. LEXIS 628, one recalls the last words of the dissent:

Although it relied on expert testimony to understand the science underlying petitioners’ claims, the District Court made no “findings of fact” as that term is used in Rule 52(a)(6)

One might question whether crediting opinions of expert establishes "findings of fact"; assuming that opinions may be deemed facts, one readily sees that the opinions/facts in the Teva case. are false and thus are clearly erroneous.  It is foreseeable that the CAFC will find the underlying facts relied upon by SDNY to be clearly erroneous.  
Given that the majority opinion in 2015 US Lexis 628 seems to suggest that a district court's reliance on expert opinions is subject to clear error review, one expects a consequence of the majority decision will be more expense directed to expert opinions and expert opinions to challenge expert opinions.    This becomes an interesting avenue to transmogrify "purchased opinions" into something which can be treated as facts.
A separate consequence will be re-evaluation of a party stipulating to infringement to seek review at the CAFC (eg, Gevo v Butamax).  


Problems with the facts of the SDNY decision:

From Wikipedia:

The mode is the value that appears most often in a set of data. The mode of a discrete probability distribution is the value x at which its probability mass function takes its maximum value. In other words, it is the value that is most likely to be sampled. The mode of a continuous probability distribution is the value x at which its probability density functionhas its maximum value, so, informally speaking, the mode is at the peak.

(...)

The mode is not necessarily unique, since the probability mass function or probability density function may take the same maximum value at several points x1x2, etc. The most extreme case occurs in uniform distributions, where all values occur equally frequently.




Thus, when SDNY interpreted "average molecular weight" to be the mode of the molecular weight distribution, it represented an average by something which is not an average:



The Court construed "average molecular weight" to mean "peak molecular weight detected using an appropriately calibrated suitable gel filtration column." (CCO at 40 and n.10; Sept. Tr. (Grant) 211:5-15; PTX 986 at 25.)


If there were a "finding of fact" that an "average molecular weight" was the mode of the molecular weight distribution, it would be false and thus clearly erroneous.

Because the mode of a distribution is not necessarily unique, such a finding of fact would also be ambiguous.

As to the text



Second, although SEC can provide Mp, this disclosure is insufficient, Mylan argues, in view of the fact that it can also provide Mw and Mn. (Ryu Decl. ¶ 41.) This argument fails because, as explained above, Mp is the only type of AMW that can be provided directly by SEC without "further data manipulation and calculation." (Grant  [] Decl. ¶ 70 (Teva v. Mylan claim construction).) Since the patents-in-suit do not disclose any additional calculations, the Court credits Dr. Grant's representation that a person of ordinary skill in the art would understand that AMW means Mp. (See id.)


First, because Mp (which is the mode of the molecular weight distribution) is not an average, the finding that it is an AMW (average molecular weight) is wrong and clearly erroneous.  Second, true measures of average molecular weight, such as Mn or Mw, could be calculated from SEC curves by methods known to one of ordinary skill at the time of filing.  That the mode can be observed directly (although not necessarily unambiguously ) does not negate that true measures of average molecular weight could be calculated at the time of filing from the data in the specification.  A finding of fact that one of ordinary skill would understand that AMW means Mp is false and thus clearly erroneous.

Posner quoted in article on "Deflate-gate"

From the post

Does Deflategate mean cheaters prosper in NFL?

 




One recalls Judge Richard Posner's observation that we seem to view plagiarism committed by successful authors as "a chump's crime, less likely to reflect a serious larcenous intent than a loose screw." He adds: "The more successful the writer, the more nutty-seeming the plagiarism."

National Journal discusses Michelle Lee before the Senate Judiciary Committee

From the post

Obama Nominee Stays Mum on Fighting Patent Trolls




In her second appearance in as many months before the Senate Judiciary Committee on Wednesday, Lee told lawmakers there "should be additional improvements to our patent system through legislation." But when pressed by Republican Sen. Orrin Hatch and others to discuss specifics, such as controversial fee-shifting provisions, Lee demurred, urging the senators to take a prudent course that incorporated the "changing patent landscape," which, she explained, includes several recent Supreme Court decisions and changes in the pace of infringement claims being filed.
On Thursday, Lee reiterated her view that legislative reform is necessary as part of broader, holistic efforts across government to deal with abusive troll activity, which some studies have claimed cost the economy tens of billions of dollars annually. Speaking at an event at the Brookings Institution, Lee was asked several times about congressional reform but continued to elide specifics.



US 20150024450 on alcoholic fermentation to produce ethanol

From within US 20150024450 to Mascoma:


Ethanologenic organisms, such as Zymomonas mobilis, Zymobacter palmae, Acetobacter pasteurianus, or Sarcina ventriculi, and some yeasts (e.g., Saccharomyces cerevisiae), are capable of a second type of anaerobic fermentation, commonly referred to as alcoholic fermentation, in which pyruvate is metabolized to acetaldehyde and CO.sub.2 by pyruvate decarboxylase (PDC). Acetaldehyde is then reduced to ethanol by ADH regenerating NAD.sup.+. Alcoholic fermentation results in the metabolism of one molecule of glucose to two molecules of ethanol and two molecules of CO.sub.2. If the conversion of pyruvate to undesired organic acids could be avoided, as detailed above, then such a genetically modified microorganism would have an increased ability to produce ethanol as a fermentation product.


Some background on issues in the recently decided Supreme Court case, Teva V. Sandoz, 2015 U.S. LEXIS 628


As to the recently-decided Supreme Court case in Teva v. Sandoz, 2015 U.S. LEXIS 628, one observes the last words of the dissent:



Although it relied on expert testimony to understand the science underlying petitioners’ claims, the District Court made no “findings of fact” as that term is used in Rule 52(a)(6). Thus, the Court of Appeals properly reviewed the District Court’s conclusions of law de novo. I respectfully dissent.

 


Rule 52(a)(1) states in part --the court must find the facts specially  --AND 52(a)(6) states - Findings of fact, whether based on oral or other evidence, must not be set aside unless clearly erroneous --

An interesting aspect is that there seem to be no explicit findings of fact specially found. 

As to the now-vacated Federal Circuit decision, one notes that Judge Moore wrote the underlying CAFC decision, 723 F.3d 1363 (CAFC 2013).

The portion of the CAFC decision investigated by the Supreme Court is relatively short:

---;

Appellants argue that the term "molecular weight" renders all of the asserted claims indefinite because it can refer to different measures, including Mp, Mw, and Mn. They contend that the scope of the claims varies significantly depending on the measure and that a skilled artisan cannot ascertain the boundaries of the claims. Appellants argue that Teva inconsistently defined "molecular weight" as Mw and Mp during prosecution of two of the familial patents, reinforcing the ambiguity. Further, Appellants contend that the specification does not resolve which molecular weight measure is intended.
Appellants also contend that their indefiniteness arguments apply equally to Group I and Group II claims. They argue that even Group II claims, which refer to a molecular weight range,  [] "necessarily refer to a copolymer-1 percentage above or below a certain average molecular weight." Sandoz Reply Br. 17. Appellants contend that, because all of the claims recite "molecular weight," they must be indefinite.
Teva counters that the prosecution history clarifies that "molecular weight" should be construed as Mp. It contends that its response to an indefiniteness rejection of the '539 patent claims unequivocally stated that a person of skill in the art reading the specification would understand that the term "molecular weight" refers to Mp. Teva argues that the district court correctly determined that its response during prosecution of the '847 patent, where it stated that "[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight," was not contradictory. J.A. 3229. It contends that a skilled artisan would discount this statement because it does not explicitly define "molecular weight" as Mw and because it contains an evident scientific error—any molecular weight measurement, not just Mw, may be expressed in kilodalton units.
Teva also contends that the specification resolves any ambiguity in the meaning of "molecular  [] weight." Teva contends that the specification's reference to the Size Exclusion Chromatography (SEC) method indicates that "molecular weight" means Mp because determining Mn and Mw requires further calculations from SEC data that the specification does not describe. It further argues that Figure 1 confirms this conclusion because only Mp can be obtained directly from the molecular weight plot in that figure.
Finally, Teva contends that Group II claims refer to exact molecular weight values and are therefore not ambiguous. It argues that Group II claims recite percentages of molecules in a copolymer-1 sample that fall within a specified molecular weight range, not average values.
 [p. 1369]  We agree with Appellants that Group I claims are indefinite and agree with Teva that Group II claims are not. It is undisputed that Group I claims contain an ambiguity because their plain language does not indicate which average molecular weight measure is intended. Teva's attempt to resolve this ambiguity hinges in part on the prosecution history. But two of its prosecution statements directly contradict each other and render the ambiguity insoluble.
During prosecution of the '539 patent, the Examiner rejected  [] pending claims as indefinite, stating that "the term 'average molecular weight' . . . is indefinite since its method of measurement is not specified, i.e. [Mn], [Mw] . . . etc." J.A. 3245. Teva stated in its response that "[o]ne of ordinary skill in the art, upon reviewing the specification, would understand that 'average molecular weight' refers to the molecular weight at the peak of the molecular weight distribution curve shown in Figure 1," i.e., Mp. J.A. 3258. The claims were allowed. During prosecution of the '847 patent, the Examiner made an analogous rejection over the same claim term, stating that "the term 'average' molecular weight . . . is meaningless as a limitation without specifying its basis, e.g., [Mw], [Mn], etc." J.A. 3220. Teva overcame the rejection by responding that "[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight," i.e., Mw. J.A. 3229. The only basis upon which the Examiner could have agreed that the '539 patent claims were not indefinite was that "molecular weight" means Mp. In contrast, the only basis for the Examiner's withdrawal of the indefiniteness rejection of the '847 patent claims  [] was that the same term means Mw. Teva's two definitions cannot be reconciled.
The specification does not resolve the ambiguity. Teva's expert, Dr. Gregory Grant, testified that after examining the curve depicted in Figure 1 and the accompanying legend, a skilled artisan would know that the claim terms "molecular weight" and "average molecular weight" denote Mp. Dr. Grant also testified that Example 1's discussion of gel filtration, which refers to the SEC method for measuring molecular weight, tells a skilled artisan that "molecular weight" refers to Mp. See '808 patent, col. 3 ll. 6-8. He explained that only Mp, which is simply the highest point of a molecular weight curve, can be read directly from a plot of SEC data.
On de novo review of the district court's indefiniteness holding, we conclude that Dr. Grant's testimony does not save Group I claims from indefiniteness. As Dr. Grant himself opined, SEC does not exclusively provide Mp—both Mn and Mw can also be obtained from the data generated by the SEC method after some calculations. J.A. 1005. His testimony is consistent with that of one of Appellants' experts, who opined that SEC "can give at least peak average, number average,  [] and weight average 'molecular weights.'" J.A. 1229. Furthermore, as illustrated in the figure below, the peaks of the curves in Figure 1 do not correspond to the values denoted as "average molecular weight" in the figure's legend (Appellants' additions in color). In fact, the 7.7 kDa value is closer to the Mw than to the Mp of the corresponding batch, which makes it difficult to conclude that Mp is the intended measure. J.A. 5285. Thus, we hold that Group I claims are indefinite.


<-->

The Supreme Court decision makes reference to 810 F. Supp. 2d 578.  
 
-->from  810 F. Supp. 2d 578 (SDNY 2011) -->

Outside the context of copolymer-1 mixtures, there is virtually no dispute that "molecular weight" means the sum of the atomic weights of the atoms making up a molecule. 6 (See Sandoz Opening Claim Construction Br. at 9 (conceding that Teva's proposed construction "may be  [] an acceptable definition for 'molecular weight' when referring to a small molecule, such as water, in which every molecule has the same molecular weight"); see also Grant Decl. ¶¶ 24, 54 (Teva v. Sandoz claim construction).) Because complex non-uniform mixtures, such as copolymer-1, often include molecules of varying weights, however, the molecular weight of such mixtures cannot be characterized by the molecular weight of any single species. (Id. ¶ 36.) "The most precise way of describing the molecular weight of such" mixtures, according to Dr. Grant, "is a complete molecular weight distribution." (Id.) For practical purposes, "the molecular weight of a polymer is often expressed in a single, average molecular weight" ("AMW"). (Id.)

The parties agree that for mixtures such as copolymer-1, several different types of AMW can be determined, including number average molecular weight ("Mn"), weight average molecular weight ("Mw"), z average molecular weight ("Mz"), viscosity average molecular weight ("Mv"), and peak average molecular weight ("Mp"). 7 (See Ryu Decl. ¶¶ 23, 41 (Teva v. Mylan claim construction); see also Grant Decl. ¶¶ 38-39 (Teva v. Sandoz claim construction).)


The "'claims themselves'" are silent as to the meaning of AMW. Accordingly, the Court looks to "'the specification, the prosecution history, and extrinsic evidence.'" Id. at 1314 (citations omitted). In Phillips, the Federal Circuit explained that the specification is usually "'dispositive; it is the single best guide to the meaning of a disputed term.'" Id. at 1315 (citation omitted). "The close kinship between the written description and the claims is enforced by the statutory requirement that the specification describe the claimed invention in 'full, clear, concise, and exact  [*588]  terms.'" Id. at 1316 (quoting 35 U.S.C. § 112, para. 1).
Here, the specification expressly describes use of a method called size exclusion chromatography ("SEC"), in which a sample is passed  [] through a gel-filled column. ('808 patent at 3:3-8.) SEC, which "was well understood at the time the patent applications were filed in 1994[,]" according to Dr. Grant, is typically "performed by passing a solution of a polymer down a column packed with a porous gel." (Grant Decl. ¶ 40 (Teva v. Sandoz claim construction).) The gel contains pores of varying sizes into which some, but not all, of the copolymer molecules may fit. (Id.) When a polymer sample is run through the size exclusion column, Dr. Grant explains, the larger molecules that cannot fit in all of the pores go ground them and come out of the column earlier. (Id.) Smaller molecules, by contrast, diffuse more easily into the pores, thus taking a longer route through the gel and coming out later. (Id.) As a sample comes out of the column, the polypeptides are measured by ultraviolet ("UV") light absorption. (Id. ¶ 41.) The amount of UV light absorbed is proportional to the amount of polypeptide present. (Id. n.12.) SEC generates a chromatogram "by plotting UV absorbance versus elution volume or retention time. The peak on the chromatogram corresponds to a fraction that contains the largest amount of polymer, the molecular  [**32] weight of which is the peak or 'peak average' molecular weight." (Id. ¶ 41.) Thus, Teva (and Dr. Grant) conclude, Mp can be read from the chromatogram generated by SEC without any "further calculation" and would be understood by a person of ordinary skill in the art to be the presumed meaning of AMW in the context of the patents-in-suit. (Id. ¶ 61.)
Dr. Grant adds that while "[p]eak molecular weight can be obtained directly from the chromatogram and the calibration curve, . . . further data manipulation and calculation is needed to calculate either the weight average molecular weight or the number average molecular weight." (Id.) Because "[t]he specification does not describe the calculation of the average molecular weight," a person of ordinary skill in the art would have understood, according to Dr. Grant, that the AMW "referred to is a peak molecular weight." (Id.)
The Court credits and accepts all of Dr. Grant's opinions regarding SEC. See Phillips, 415 F.3d at 1318 ("expert testimony can be useful . . . to provide background on the technology at issue . . . [and] to ensure that the court's understanding of the technical aspects of the patent is consistent with that of a person of  [] skill in the art") (citations omitted).

Example 1 in the specification describes a method for measuring the AMW of a sample of copolymer-1 using SEC. ('808 patent at 3:3-8.) Teva argues, and the Court agrees, that a person of ordinary skill in the art would understand that Figure 1 in the specification relates to Example 1. Figure 1 depicts three molecular weight distributions curves. ('808 patent at Fig. 1.) Two have an AMW of 7.7 kilodaltons ("kDa"). (Id.) The other has an AMW of 12.0 kDa. (Id.) The specification states that Figure 1 "displays the molecular weight distribution of three batches of copolymer-1, showing the proportion of species with molecular weight above 40 KDa." (Id. at 1:57-59.) Dr. Grant explains that a person of ordinary skill in the art would understand that Figure 1 does not represent raw data off of a size exclusion column, but, rather, would understand that the SEC apparatus and its UV detector would generate a chromatogram, which would have to be converted into the graph shown in Figure 1 in the patent. (Grant Decl. ¶¶ 41, 62 (Teva v. Sandoz claim construction).)
 [*589]  Finding that the samples described in Example 1 correspond to the data described in Figure 1, a  [**34] person of ordinary skill in the art would understand, according to Dr. Grant, that the listed AMWs fall approximately at the peaks of the curves. (Id. ¶ 62.) A person of ordinary skill in the art would also understand, Dr. Grant explains, "that the process of transferring the data from the chromatogram would likely cause the peak on each curve to shift slightly." (Id.) Thus, a person of ordinary skill in the art would understand that any discrepancy between the peak values read from the chromatogram (7.7 kDa and 12.0 kDa) and the peak of Figure 1 is merely a byproduct of the process by which the data from the chromatogram would have been used to generate Figure 1. (Id.) The Court credits all of Dr. Grant's explanation regarding Example 1 and Figure 1. See Phillips, 415 F.3d at 1318.
In addition to the specification, the prosecution history also indicates AMW refers to Mp in the context of the patents-in-suit. The prosecution history, which, along with the specification, is referred to as "'intrinsic evidence,' consists of the complete record of the proceedings before the [Patent and Trademark Office ("PTO")] and includes the prior art cited during the examination of the patent." Id. at 1317  [] (citation omitted). The prosecution history, like the specification, "provides evidence of how the PTO and the inventor understood the patent." Id. (citation omitted). Since "the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation," however, "it often lacks the clarity of the specification and thus is less useful for claim construction purposes." Id. (citations omitted). Here, the prosecution history is just as useful as the specification.
The term "average molecular weight" was first used during the prosecution of the '539 patent. Teva stated it sought claims to "[a] copolymer-1 composition comprising a mixture of polypeptides composed of glutamic acid, lysine, alanine and tyrosine, wherein the mixture has an average molecular weight of about 4 to about 9 kilodaltons." (Crystal Decl. Ex. 13 at TEV000304783 (Teva v. Mylan claim construction).) The patent examiner rejected the claims directed to "average molecular weight" as indefinite on the basis that the PTO could not determine what average was being claimed:
Where a claimed value varies with its method of measurement and several alternative methods  [] of measurement are available, the claimed value is indefinite without knowing which method of measurement was used. Honeywell Intl., Inc. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Accordingly, the term "average molecular weight" . . . is indefinite since its method of measurement is not specified, i.e., number average molecular weight, weight average molecular weight, average molecular weight as determined by light scattering, etc.
(Crystal Decl. Ex. 12 at TEV000304691 (Teva v. Mylan claim construction).)

In response to the rejection, Teva pointed to the specification to explain that a person of ordinary skill in the art would understand AMW to mean "peak average molecular weight":
According to the examiner, the term "average molecular weight" is indefinite. Applicants respectfully disagree. One of ordinary skill in the art, upon reviewing the specification, would understand that "average molecular weight" refers to the molecular weight at the peak of the molecular weight distribution curve shown in Figure 1, which is "% of the total mass" versus "molecular weight." As shown in Figure 1, the "average molecular  []  weight" is 7.7 kDa for the separated copolymer-1 ("Batch  [] A") described in Example 1, and 12.0 kDa for the unseparated copolymer-1."
(Crystal Decl. Ex. 13 at TEV000304803 (Teva v. Mylan claim construction).) The patent examiner accepted Teva's explanation and issued a Notice of Allowability, specifically noting Teva's "remarks and amendments." (Crystal Decl. Ex. 14 (Teva v. Mylan claim construction).)

In situations like this, where a patent examiner has specifically raised an indefiniteness objection and the issue has been resolved to the patent examiner's satisfaction, "[t]here is a 'heavy presumption against [a party] arguing that the patents and claims do not comply with 35 U.S.C. § 112." See Mas-Hamilton Grp. v. LaGard, Inc., 21 F. Supp. 2d 700, 717 (E.D. Ky. 1997) (citations omitted).


(...)


Second, although SEC can provide Mp, this disclosure is insufficient, Mylan argues, in view of the fact that it can also provide Mw and Mn. (Ryu Decl. ¶ 41.) This argument fails because, as explained above, Mp is the only type of AMW that can be provided directly by SEC without "further data manipulation and calculation." (Grant  [] Decl. ¶ 70 (Teva v. Mylan claim construction).) Since the patents-in-suit do not disclose any additional calculations, the Court credits Dr. Grant's representation that a person of ordinary skill in the art would understand that AMW means Mp. (See id.)
Lastly, Mylan concedes that Mp may be derived from Figure 1, but argues that Figure 1 does not show peaks of either 7.7 kDa or 12.0 kDa. (Ryu Decl. ¶ 42.) This argument fails because, as Dr. Grant explained, a person of ordinary skill in the art would understand, based on Example 1's reference to SEC, that Figure 1 was created by transforming data from a chromatogram to the curves depicted in Figure 1. (Grant Decl. ¶¶ 44-53 (Teva v. Mylan claim construction); see also Grant Decl. ¶ 62 (Teva v. Sandoz claim construction).) A person skilled in the art would understand, according to Dr. Grant, "that the process of transferring the data from the chromatogram would likely cause the peak on each curve to shift slightly." (Grant Decl. ¶ 62 (Teva v. Sandoz claim construction); see also Grant Supp. Decl. ¶ 7 (Teva v. Mylan claim construction).) As a  [*591]  result, the fact that the peaks in Figure 1 do not match the listed AMWs precisely would not dissuade  [**40] a person of ordinary skill in the art from concluding that AMW refers to Mp in the context of the patents-in-suit.
Sandoz, for its part, devotes substantial energy to discrediting Dr. Grant and his explanation regarding how one of ordinary skill in the art would understand Figure 1. Sandoz relies almost exclusively, however, on unsubstantiated attorney-argument. The Court finds that Sandoz's unsubstantiated attorney-argument is insufficient to cast doubt on Dr. Grant's opinions, which, as explained above, the Court credits and accepts. See Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1068 (Fed. Cir. 2005) (HN12Go to this Headnote in the case."Unsubstantiated attorney argument regarding the meaning of technical evidence is no substitute for competent, substantiated expert testimony.")

**The 2011 case includes the text 
--SUBSEQUENT HISTORY: Findings of fact/conclusions of law at Teva Pharms. United States v. Sandoz, Inc., 876 F. Supp. 2d 295, 2012 U.S. Dist. LEXIS 91022 (S.D.N.Y., 2012)
Affirmed in part and reversed in part by Teva Pharms. USA, Inc. v. Sandoz, Inc., 2013 U.S. App. LEXIS 15208 (Fed. Cir., July 26, 2013)
  -- 


It is not clear that 876 F. Supp. 2d 295 sets out distinct findings of fact and conclusions of law, as required by FRCP 52. 

--->from 876 F. Supp. 2d 295 (SDNY 2012), June 29, 2012, Filed-->


As to molecular weight:

--

i. Average Molecular Weight Limitations
Claim 1 of the '808 patent, claim 1 of the '589 patent, claims 1 and 6 of the '847 patent and claims 1, 8, 9, 10, 12, 23, 30, and 31 of the '539 patent are directed to copolymer-1 having an "average molecular weight" falling within a particular numeric range. (PTX 1; PTX 2; PTX 7; PTX 8.) For example, claim 1 of the '539 patent provides:
A copolymer-1 composition   comprising a mixture of polypeptides composed of glutamic acid, lysine, alanine and tyrosine, wherein the mixture has an average molecular weight of about 4 to about 9 kilodaltons, wherein the mixture of polypeptides is non-uniform with respect to molecular weight and sequence, and wherein the composition is suitable for treating multiple sclerosis.
(PTX 8 at 5:18-24 (emphasis added).)
The asserted claims containing "average molecular weight" limitations require copolymer-1 having an average molecular weight of "about 5 to 9 kilodaltons" (claim 1 of the '808 patent and claim 1 of the '589 patent), "about 4 to about 9 kilodaltons" (claims 1 and 6 of the '847 patent and claims 1, 8, 9, 12, 23, 30, and 31 of the '539 patent), and "6.25 to 8.4 kilodaltons" (claim 10 of the '539 patent). (PTX 1; PTX 2; PTX 7; PTX 8.)


--

1) Average Molecular Weight Limitations
The Court construed "average molecular weight" to mean "peak molecular weight detected using an appropriately calibrated suitable gel filtration column." (CCO at 40 and n.10; Sept. Tr. (Grant) 211:5-15; PTX 986 at 25.) Mylan's method for determining the peak molecular weight values of its product involves using an appropriately  [] calibrated suitable gel filtration column. (Sept. Tr. (Grant) 250:23-254:22; PTX 318 at MYL0000111-12; PTX 330 at MYL0000765-66.)
 [p. 348]  Based on Dr. Grant's testimony, which the Court credits, and the peak molecular weight data in Mylan's ANDA, Mylan's proposed product meets the molecular weight limitations of claim 1 of the '808 patent and claim 1 of the '589 patent, which require a copolymer-1 having an average molecular weight of "about 5 to 9 kilodaltons;" claims 1 and 6 of the '847 patent and claims 1, 8, 9, 12, 23, 30, and 31 of the '539 patent, which require a copolymer-1 having an average molecular weight of "about 4 to about 9 kilodaltons;" and claim 10 of the '539 patent, which requires a copolymer-1 with an average molecular weight of "6.25 to 8.4 kilodaltons." (Sept. Tr. (Grant) 259:24-260:22; PTX 986 at 24, 45.)



--

Why molecular weight was important:

--
Finally, the Teva and Weizmann scientists discovered that toxicity—the cause of the side effects Dr. Bornstein observed during his clinical trial—was related to the molecular weight of the product. (July Tr. (Pinchasi) 27:25-28:25.) The higher the average molecular weight of a copolymer-1 batch, the higher the probability that the batch would be toxic. (July Tr. (Pinchasi) 27:25-28:25; July Tr. (Arnon) 332:8-333:6; DTX 3567 (Konfino Dep. Tr. Vol. 1) at 62:24-63:9.) In particular, they discovered that there was a narrow molecular weight range between 5,000 and 9,000  [**50] daltons in which there is a high probability that a copolymer-1 batch will be both active and non-toxic. (July Tr. (Arnon) 333:7-17; July Tr. (Pinchasi) 34:6-35:5.)

<--end 2012="" br="" case="" nbsp="">

From FRCP 52(a):


In an action tried on the facts without a jury or with an advisory jury, the court must find the facts specially and state its conclusions of law separately. The findings and conclusions may be stated on the record after the close of the evidence or may appear in an opinion or a memorandum of decision filed by the court.




As to Rule 52, note:


Unt v. Aerospace Corp., 765 F.2d 1440, 1444 (9th Cir. 1985) (holding that factual findings made by a judge after a bench trial "must be explicit enough to give the appellate court a clear understanding of the basis  of the trial court's decision, and to enable it to determine the ground on which the trial court reached its decision"


from 458 F.3d 955 (CA9 2005)

***from page 717 of  21 F. Supp. 2d 700 :

--

Plaintiff insists that this information  [*717]  is critical to practicing the '656 patent lock. Consequently, the alleged inventors were [**30]  well aware of this critical and necessary requirement and a better way of practicing the alleged invention, but concealed and failed to disclose it.
55. The testimony heard at trial compels the conclusion that one of ordinary skill in the art would appreciate that the solenoid must contain some magnetic material in order to work properly. Likewise, the lack of detailed tolerancing or solenoid energization timing information in the '656 patent would not prevent one of ordinary skill in the art from practicing the '656 patent. Therefore, the Court finds that Plaintiff has failed to establish by clear and convincing evidence that the '656 patent is invalid for failing to meet the best mode requirement.
G. ENABLEMENT
56. Mas-Hamilton asserts that the '656 patent is invalid for failing to meet the enablement requirement. The specification of a patent must contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. 35 U.S.C. § 112. In order to be considered []  enabling, a patent must give persons of ordinary skill in the relevant art enough information to practice the invention disclosed in the specification without undue experimentation. In re Alton, 76 F.3d 1168, 1172, n. 5 (Fed. Cir. 1996). A patent is invalid if a person skilled in the pertinent art, using the knowledge available to that person, and the disclosure in the patent document, could not make and use the invention without undue experimentation. Northern Telecom, Inc. v. Datapoint, Inc., 908 F.2d 931, 941 (Fed. Cir. 1990). The purpose of this requirement is to insure that the inventor provides sufficient information about the claimed invention. Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565, 1571 (Fed. Cir. 1991). It is not sufficient that a person following the disclosure might obtain the results set forth in the claims; it must invariably happen. Gubelmann v. Gang, 56 C.C.P.A. 1013, 408 F.2d 758, 766 (C.C.P.A. 1969).

57. Plaintiff argued at trial that the '656 patent provides insufficient information concerning solenoid timing, construction of the solenoid housing, and relative tolerancing of the solenoid housing and lever in order []  to enable a person of ordinary skill in the art to build a working lock mechanism.
58. Having heard the testimony at trial, the Court finds that the information contained in the '656 patent would allow one of ordinary skill in the art to practice the '656 patent. Thus, Plaintiff has failed to establish by clear and convincing evidence that the '656 patent is invalid for failing to meet the enablement requirement.
H. INDEFINITENESS
59. Mas-Hamilton asserts that the claims at issue are invalid because they are indefinite as written or as asserted by LaGard. Patent claims must particularly point out and distinctly claim the subject matter which the patentee regards as his invention. 35 U.S.C. § 112. A claim is invalid for failing to meet this requirement if those in the relevant art would not understand what is being claimed in the patent. Amgen, Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1217 (Fed. Cir. 1991). Thus, the requirement is that the language of the claims must make it clear what subject matter they encompass. PPG Industries, Inc. v. Guardian Industries Corp., 75 F.3d 1558, 1562 (Fed. Cir. 1996). The statute sets forth a requirement [**33]  for precision and definiteness of claim language. Id.

60. The Patent Office understood the terms used in the '656 patent claims. There is a "heavy presumption against [Mas-Hamilton] in arguing that the patents and claims do not comply with 35 U.S.C. § 112 where the Examiner reviewed the adequacy of the descriptions and found the patent descriptions to be definite and allowed the patents thereafter." Water Tech. Corp. v. Calco Ltd., 658 F. Supp. 961, 972 (N.D.Ill.1986), aff'd in part, rev'd in part, 850 F.2d 660 (Fed.Cir.), cert. denied, 488 U.S. 968 (1988).

 [*718]  61. Based on the evidence and testimony presented at trial, the Court finds that the '656 patent claims make clear what subject matter is covered and encompassed in the patent. Plaintiff has therefore failed to establish by clear and convincing evidence that the '656 patent is invalid on grounds of indefiniteness.
I. ANTICIPATION/OBVIOUSNESS
62. HN20Go to this Headnote in the case.A patent may be found invalid based upon various types of prior art. 35 U.S.C. § 102. A patent may also be invalid if the differences between the subject matter patented and the prior art are such that the subject matter as a whole would have [**34]  been obvious at the time the invention was made to a person having ordinary skill in the art. 35 U.S.C. § 103.
63. Plaintiff argues that according to LaGard, the primary difference between the alleged invention in the '656 patent and the prior art was the concept of positively moving the lever into contact with the cam wheel only after the proper combination was entered. Plaintiff contends that LaGard admitted that it has in its possession "voluminous" prior art documents showing this concept. However, Plaintiff claims that LaGard failed to produce those documents, in violation of this Court's order. Thus, Plaintiff invites the Court to draw an adverse inference that those documents, if produced, would invalidate the asserted claims of the '656 patent either as an anticipation or as obvious.
64. Having heard the testimony and arguments at trial, the Court finds that there is no evidence that the '656 patent is invalid due to prior art. Further, the Court will draw no adverse inference from LaGard's production of documents, or lack thereof, during discovery. Accordingly, the Court finds that Plaintiff failed to establish by clear and convincing evidence that the '656 patent [**35]  is invalid due to anticipation or obviousness.
CONCLUSION ON VALIDITY
65. Based on the evidence produced at trial, and for the reasons expressed above, the Court finds that Plaintiff has failed to establish by clear and convincing evidence that the '656 patent is invalid for any reason. Thus, Plaintiff has failed to rebut the presumption that a patent issued by the Patent Office is valid. Accordingly, the Court finds that the '656 patent is valid.
IV. PATENT INFRINGEMENT


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