Tag Archives: motivation to combine

Obviousness Law: A Reasonable Expectation of Success

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In re Stepan Co. (Fed. Cir. 2017)

In a split decision, the Federal Circuit has vacated the PTAB ruling that Stepan’s claims are not patentable.  The claims here are directed to the use of ultra-high concentrate glyphosate and a particular surfactant to ensure “better adherence to leaves, thereby enhancing penetration.”  Although the PTAB (Board) found motivation to combine elements of the prior art to form the claimed system, the Board did not fully support that PHOSITA would have a ‘reasonable expectation’ that the combination would be a success.

Success

The decision here thus goes to the core of obviousness law:

The majority: An obviousness determination requires finding both “that a skilled artisan would have been motivated to combine the teachings of the prior art . . . and that the skilled artisan would have had a reasonable expectation of success in doing so.” quoting Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016). . . . Absent some additional reasoning, the Board’s finding that a skilled artisan would have arrived at the claimed invention through routine optimization is insufficient to support a conclusion of obviousness. (Majority opinion by Judge Moore and joined by Judge O’Malley).

The Dissent (Judge Lourie): Where, as here, there is a single prior art reference, there does not need to be a finding of reasonable expectation of success for those skilled in a particular art to make conventional modifications to the prior art and look for improvements in some parameter. See In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017).

Majority’s Response in FN.1: The dissent suggests the PTO need not establish a reasonable expectation of success where there is a single prior art reference. We do not agree. Whether a rejection is based on combining disclosures from multiple references, combining multiple embodiments from a single reference, or selecting from large lists of elements in a single reference, there must be a motivation to make the combination and a reasonable expectation that such a combination would be successful, otherwise a skilled artisan would not arrive at the claimed combination.

To be clear here, the PTAB did appear to find a reasonable expectation of success. [PTAB Decision] The holding here though is that such a broad conclusory finding must also be supported by specific factual findings targeted to the patent at hand.  An important element of this decision is that the majority particularly held that the lack of factual findings supporting the PTO’s conclusion meant that the agency had not even established a prima facie case of obviousness.

Image result for stepan company

When is an the inherent, but unexpected result obvious?

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Millennium Pharma v. Sandoz (Federal Circuit 2017)

As part of a brand-generic pharma battle, the district court invalidated a set of Millennium’s patent claims covering its Velcade drug used to treat multiple myeloma.[1]  The district court held that the claims (covering the chemical compound active ingredient) were obvious as the inherent result of an obvious process.

In particular, the claims cover a freeze dried (“lyophilized”) version of the compound “D-mannitol N-(2- pyrazine) carbonyl-L-phenylalanine-L-leucine boronate.”  The active portion of the compound is the boronate (bortezomib), which was known to work but was unstable. Researchers tried and failed to create liquid formations and so turned to freeze-drying.  To achieve that end, mannitol was added to the compound in a way formed a chemical bond with the boronate – leading to dramatic improvement in stability.  When a patient ingests the new drug (a “prodrug”), the body breaks-down the compound and allows the active ingredient to work.

The boronate portion was known in the prior art for its medical use and the mannitol portion was a known bulking agent.  The process of freeze-drying was also known.  However:

No reference taught or suggested reacting bortezomib with mannitol, and no reference hinted that … an esterification reaction might occur during lyophilization. No reference taught or suggested that the product of such lyophilization would be a new chemical compound that would solve the problems that had inhibited development of bortezomib in oncology.

In its decision, the district court recognized that the resulting compound was likely unexpected, but focused on the process of getting to that result – holding that the claimed compound was simply the “natural result” inherent to the lyophilized process and that it would have been obvious to try the process on boronate + mannitol.   On appeal, the Federal Circuit has reversed.

The easy part of the decision for the district court focused-in on the motivation to combine boronate and mannitol.  The district court found that an Adams Patent “pointed directly to mannitol” for the combination.  However, according to the Federal Circuit, “the Adams Patent’s fail[s] to mention mannitol.”

In my view, this easy-part is sufficient for the patentee to win, and my preference would be for the court to delete the rest of its muddled opinion – and instead rest its case on the lack of the motivation to combine.  The remainder of the decision is somewhat difficult to follow because it jumps back and forth dancing around but never answering the basic question: If the combination would have been obvious to try, would its natural result also be considered obvious?  At times, the court appears to agree that obviousness would follow, while other sections of the opinion suggest the compound would not have been obvious since its actual structure was so unexpected.

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A patent claim is obvious when, “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.”[2]  Here the appellate panel focused the question to: “whether a person of ordinary skill, seeking to remedy the known instability and insolubility and to produce an efficacious formulation of bortezomib, would obviously produce the D-mannitol ester of bortezomib, a previously unknown compound.”

On the topic of inherency in particular, the court seems to have simply strung together several loosely related sentences.  Take the following pair as an example:

Sandoz argues that although lyophilization in the presence of mannitol produced an unexpected result, the result was “inevitable” and thus “inherent,” and thus not “inventive.” However, invention is not a matter of what the inventor intended when the experiment was performed; obviousness is measured objectively in light of the prior art, as viewed by a person of ordinary skill in the field of the invention . . .

In the end, the reversal makes sense, but the law created is somewhat of a mess.

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[1] Millennium Pharm., Inc. v. Sandoz Inc., No. 12-1011, 2015 WL 4966438 (D. Del. Aug. 20, 2015); U.S. Patent No. 6,713,446.

[2] 35 U.S.C. 103.

Court-Agency Allocations of Power and the Limits of Cuozzo

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Guest post by Saurabh Vishnubhakat, Associate Professor at the Texas A&M University School of Law and the Texas A&M College of Engineering.  Although Prof. Vishnubhakat was an advisor at the USPTO until June, 2015, his arguments here should not be imputed to the USPTO or to any other organization.

Prof. Vishnubhakat was counsel of record for the amicus brief by patent and administrative law professors in this case.

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Yesterday’s argument in Wi-Fi One, LLC v. Broadcom Corp. suggested that the en banc Federal Circuit are grappling with at least three important issues as they consider the reviewability of PTO decisions to institute inter partes review that arguably violate the one-year bar of 35 U.S.C. § 315(b):

  • How does the IPR statute allocate power between the PTAB and the district courts to reevaluate patent validity?
  • How does the Supreme Court’s opinion last Term in Cuozzo Speed Techs., LLC v. Lee allocate power between the USPTO Director and the Federal Circuit to oversee the PTAB?
  • How might this case resolve (or aggravate) rule-of-law concerns that the Federal Circuit has recently expressed, especially as to separation of powers under the Chenery doctrine?

The Federal Circuit’s panel decision in Achates Reference Publ’g, Inc. v. Apple Inc. held that PTAB decisions to institute IPR are unreviewable even where the § 315(b) time bar may have been violated.  The en banc question here is whether to overrule Achates.

The USPTO’s interest in the case was clear from the large group of agency employees in attendance, including members of the PTAB and the Solicitor’s Office as well as Director Michelle Lee herself.  The USPTO also formally intervened in the case and designated Mark Freeman from the DOJ Civil Division’s Appellate Staff to argue.

The PTAB-District Court Balance of Power

Historically, of course, the power to invalidate patents in the first instance resided in the district courts.  An opening exchange with Chief Judge Prost laid the groundwork that although the AIA sought efficient patent validity review outside the courts, it also constrained the administrative alternatives in a variety of ways.  The USPTO would later elaborate this point as well, that challenges that would have gone to court would now go to the agency, but this reallocation of power would not be total.  District-court defendants and their privies would have to act within a year, or never at all.  Judicial review can police this balance of power—but not without disruption of its own, and so the dispute over appealability.

The Main Cuozzo Exception: Relatedness to Institution

From early in Wi-Fi’s argument, several members of the court starting with Judge Dyk explored whether the § 315(b) time bar is distinguishable from the § 312(a)(3) particularity requirement that was found nonappealable in Cuozzo.  A well-known passage in Cuozzo orients the holding toward institutions that are made “under this section [§ 314]” or that are “closely tied” to institution-related statutes.  Meanwhile, several types of “shenanigans” may still merit review, such as constitutional defects, interpretations of less closely related provisions, or decisions whose scope and impact reach well beyond institution.  As a result, arguments to limit Cuozzo and afford review have often focused on these exceptions, especially on framing the statute as “less closely related” to institution “under this section [§ 314].”  Judges Chen and Stoll also followed up at several points with Broadcom and the USPTO about the “under this section” limitation.

Reconciling Cuozzo’s Majority and Dissent

Judge Chen also took an interesting further approach to how closely related a statute must be for Cuozzo to apply.  He noted that the dissent in Cuozzo complained specifically that the majority’s approach swept broadly and harmfully.  The Cuozzo dissent argued that the majority’s position would foreclose review even of issues such as the § 315(b) time bar because timeliness is “no less . . . closely tied” to institution.  The majority disclaimed various other horribles but was silent about the alleged relatedness of the one-year bar to institution.  Was this colloquy from Cuozzo a signal of consensus that the time bar is, indeed, the type of PTAB decision that is immune from review?

One sensible answer is that the Cuozzo dissent’s argument about the one-year bar should be seen as hortatory, intended first to build a majority and later, when the case was lost, to cabin the impact of the majority’s reasoning.  In other words, the dissent did not merely read the majority’s logic broadly but read it broadly as a reason to reject that logic.  To accept part of the Cuozzo dissent’s premise now while continuing to reject the dissent’s urged conclusion may itself be problematic cherry-picking, especially if any supposed agreement by the Cuozzo majority were to be inferred from its silence on the matter.  Indeed, Wi-Fi answered Judge Chen along just these lines by discussing what the Cuozzo dissent was trying to accomplish—limiting nonappealability to a prohibition of interlocutory review—not merely what the dissent said.

The Other Cuozzo Exception: Scope and Impact

Apart from “less closely related” statutes, the argument also started at times to explore Cuozzo’s “scope and impact” exception, particularly where the PTAB might act outside its statutory authority and thereby lose immunity from review.  It was the USPTO to whom Judge Chen suggested that the one-year bar of § 315(b) may well have been a Congressional allocation of power between the agency and the district courts to resolve patent validity disputes.  This view of the time bar would make it a statutory limit on the agency’s authority, a violation of which would render the PTAB susceptible to appellate review despite Cuozzo.

The scope and impact of § 315(b) are also stark when seen through the lens of court-agency substitution.  Arti Rai, Jay Kesan, and I have reported in recent research that a substantial share of petitioners (about 30%) seek PTAB review before being sued in district court on the patent in question.  This and related findings indicate that, in addition to ordinary court-agency competition over who resolves the validity of a patent in an ongoing infringement lawsuit, the PTAB also competes with the courts over who should resolve preemptive strikes against patents.  As the law professors’ amicus brief argued in this case, the one-year bar of § 315(b) sets an important boundary line in this competition and—as Judge Chen suggests—preserves an inter-branch allocation of power.  Thus, its scope and impact reach well outside the walls of the agency and into the federal courts, empirically as well as analytically.

The USPTO Director-Federal Circuit Balance of Power

One of the most significant aspects of this case, and why it was an apt choice for en banc review, is that the Federal Circuit is shaping its own ability to shape future cases.  Much like the balance of power between the PTAB and the district courts to evaluate patent validity in the first instance, also at stake is the power to correct errors and bring uniformity to the decision-making of the PTAB.  This latter power, too, was reallocated away from the Federal Circuit by the AIA’s nonappealability provisions.

The Source(s) of Uniformity

One might suppose, as Wi-Fi began to argue, that the absence of judicial oversight would leave individual PTAB panels to generate consensus in a common law fashion, and that consensus is unlikely to emerge because of the PTAB’s sometime disregard for its own prior analogous precedents and for prior court judgments regarding the validity of the same patent.  (Even a Federal Circuit panel endorsed the latter as recently as a month ago in Novartis AG v. Noven Pharms. Inc.)

Judge Wallach, however, strongly rejected Wi-Fi’s view that nonreviewability might leave uniformity and oversight to individual panels of the PTAB.  Instead, he noted, the Director of the USPTO can impose uniformity by assigning additional judges to particular panels to resolve contentious issues in a certain way.  To this, one might add that the Director can also generate uniformity directly through the ordinary chain of administrative command as an ex officio member of the PTAB and through the process for designating PTAB opinions as precedential, representative, or informative.  Judge Wallach raised the issue with Broadcom as well, asking whether “stacking the panel” to reach certain outcomes would qualify as judicially reviewable shenanigans.

This alternate view of uniformity is significant for its implicit but direct potential not only for displacing the Federal Circuit but also for making patent validity decisions more responsive to political constituencies.

The APA Presumption of Reviewability

The counterargument to this potential injection of politics into patent adjudication came in the closing minutes of the hearing.  For all the discussion about Cuozzo and its enumerated exceptions, Wi-Fi argued that the Cuozzo holding did not make nonreviewability the new baseline in administrative reviews of patent validity.  Rather, Cuozzo was one instance where the Administrative Procedure Act’s ever-present presumption favoring judicial review was rebutted clearly and convincingly enough as to institution decisions.  To construe the nonappealability statute as to timeliness under § 315(b) or any other issue would require a fresh analysis of statutory text, purpose, legislative history, etc.

Judge Moore engaged this argument, suggesting that Cuozzo need not be limited entirely to its facts with nonappealability decided from scratch each time.  She suggested, for example, that Cuozzo could be seen as precluding a range of appeals from institution and institution-related decisions, but that the opinion’s limitations apply here and thus dispel the indications that were clear and convincing in the Cuozzo case itself.

Notably, Judge Moore was also one of several, including Judges Newman and Reyna, to ask whether PTAB actions that are plainly invalid or ultra vires would enjoy immunity from review.  This concern, too, is of a piece with the balance of power between the Federal Circuit as judicial overseer and the Director of the USPTO as political overseer because it highlights a necessary choice between correcting agency errors and tolerating them in the name of Congressionally intended agency autonomy.

Making the PTAB Better Explain Itself

Finally, the en banc court referred at various points to the need for greater transparency in the PTAB’s own decision-making.  This is a concern that Federal Circuit panel decisions increasingly voice in PTAB appeals.  An early colloquy with Chief Judge Prost explored whether the PTAB might be shielded from review of certain issues in final written decisions simply by omitting discussion of those issues from its final written decisions, in light of the APA’s general requirement that an agency articulate its “findings and conclusions, and the reasons or basis therefor.”  Similarly, in the discussion over political panel-selection by the USPTO Director, Judge Wallach suggested that rule-of-law values such as predictability, uniformity, and transparency of judgments and the neutrality of decision-making may be threatened.

These concerns are also consistent with recent decisions finding fault with the PTAB’s failure to explain its reasoning with enough detail even to enable meaningful review.  For example, citing the Chenery doctrine, the In re NuVasive, Inc. panel decision last December reversed a finding of obviousness not because it was necessarily wrong, but because the reasoning that the PTAB had articulated could not support the decision, while the separation of powers forbade the Federal Circuit to supply its own rationale.  Similarly, in the Shaw Indus. Group., Inc. v. Automated Creel Sys., Inc. panel decision early last year, Judge Reyna wrote separately to chastise the USPTO for its opaque practice of making partial institutions while denying certain grounds or prior art as “redundant.”

Conclusion

The opportunity to clarify these allocations and reallocations of power is likely to be a welcome aspect of en banc consideration.  The power in question may be to adjudicate (as between the PTAB and the district courts), to oversee (as between the USPTO Director and the Federal Circuit), or simply to force a clearer account of the PTAB’s own reasoning.  All of these powers have seen significant revision under the AIA, reflecting the more general ascendancy of administrative adjudication in patent law.  In seeking the right balance for each of these powers, the Federal Circuit appears to be taking seriously the warning that “no legislation pursues its purposes at all costs” and that if the goals of the AIA are important, so also are the particular means that Congress enacted to achieve those goals.

Case Information

  • Oral Argument Recording
  • En Banc Panel: Prost, Newman, Lourie, Bryson, Dyk, Moore, O’Malley, Reyna, Wallach, Taranto, Chen, Hughes, Stoll
  • Arguing for Appellant Wi-Fi One, LLC: Douglas A. Cawley (McKool Smith)
  • Arguing for Appellee Broadcom Corporation: Dominic E. Massa (WilmerHale)
  • Arguing for Intervenor Michelle K. Lee, Director of the USPTO: Mark R. Freeman (DOJ Civil Division, Appellate Staff)

Generics Successful at Invalidating Novartis Gilenya Patent

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by Dennis Crouch

Novartis v. Torrent Pharma, Apotex, and Mylan (Fed. Cir. 2017)

At the conclusion of its Inter Partes Review (IPR) Trial, the Patent Trial & Appeal Board (PTAB) found all claims of Novartis U.S. Patent No. 8,324,283 invalid as obvious.  The PTAB had allowed Novartis to include substitute claims as well, but found those also unpatentable as obvious.  On appeal here, the Federal Circuit affirms.

The ‘283 patent covers a solid combination of a sphingosine-1 phosphate (S1P) receptor agonist (fingolimod) and a sugar alcohol (mannitol). The drug – sold under the trade name Gilenya – is used to treat multiple sclerosis.  This is the first oral disease modifying MS drug approved by the FDA and is a big drug with billions in sales each year.

The particular ingredients were already known in the art, and the active ingredient – fingolimod – was already known as useful for treating autoimmune diseases such as MS.  However, none of the references brought-together the entire combination in a “solid pharmaceutical composition” as required by the claims.  However, the Board found that the combination of references would have led an ordinary skilled artisan to the invention claimed here.

On appeal, the Federal Circuit reviews the Board’s factual findings for substantial evidence – a liberal and forgiving standard that only requires “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”  Conclusions of law, however, are reviewed de novo on appeal.  In patent law, the ultimate question of obviousness is deemed a question of law.  However, that ultimate conclusion must be based upon a set of predicate factual conclusions as outlined in Graham v. John Deere.

Perhaps of most relevance for many obviousness cases – the existence of a motivation-to-combine references is deemed a question of fact and thus deference is given to the PTO’s conclusion.  Here, the court noted that the board considered the negative properties of using mannitol (teaching-away), but was not convinced, and sufficient evidence supported the Board’s decision.  The patentee also focused on the fact that the Board’s written decision did not expressly consider all of the patentee’s teaching-away arguments.  On appeal, the Federal Circuit rejected that argument – holding that “there is no requirement that the Board expressly discuss each and every negative and positive piece of evidence lurking in the record to evaluate a cursory argument.” On this point, the court recognized the tension with Medichem‘s holding that the disadvantages of a reference must be considered, but held that Medichem does not create a bright-line rule requiring express discussion of all disadvantages.  Rather, the Board is “not require[d] . . . to address every argument raised by a party or explain every possible reason supporting its conclusion.” Synopsys, Inc. v. Mentor Graphics Corp., 814 F.3d 1309, 1322 (Fed. Cir. 2016).

Novartis also raised an APA challenge – arguing that the Board did not provide the required notice and an opportunity since the Board included a new reference (Sakai) in its final decision.  Sakai was raised in the IPR petition, but institution was denied for the particular grounds raising Sakai.  On appeal, the Federal Circuit sided with the PTAB holding that – although institution decision rejected Sakai as anticipatory or the primary obviousness reference – the Board did not exclude Sakai from consideration since it is clearly a relevant reference.  “The Board’s discussion of Sakai in the Final Written Decision was not inconsistent with its review of Sakai in the Institution Decision.”  With this explanation, the court was able to justify the PTAB approach and find that the agency did not “change theories in midstream without giving respondents reasonable notice of the change.”   and ‘the opportunity to present argument under the new theory.” Rodale Press, Inc. v. FTC, 407 F.2d 1252, 1256–57 (D.C. Cir. 1968).

What next: I’ll note here that the ‘283 patent is only one of four patents listed in the Orange Book covering Gilenya, one of which is also currently being challenged at the PTAB.

 

LA BioMed’s Patent Case against Cialis Revived by Federal Circuit

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by Dennis Crouch

LA BioMed v. Eli Lilly (Fed. Cir. 2017) [appeal decision ipr2014-00752] [appeal decision ipr2014-00693]

In a new pair of decisions, the Federal Circuit has again rejected the PTAB’s obviousness findings as inadequate and remanded for further proceedings.  As she has done in the past, Judge Newman agreed with the merits dissented from the remand – arguing that the challenger should not be so freely given what amounts to a new trial.

Lilly filed several separate IPR petitions against LA BioMed’s U.S. Patent No. 8,133,903 which covers a method of treating penile fibrosis which often leads to erectile dysfunction.  The IPR petitions were prompted by LA BioMed’s 2013 lawsuit alleging that Lilly’s popular Cialis drug led to infringement.  The basic idea here is that repeated treatments with Cialis has a long-term positive impact on the fibrosis.

In the two initiated IPR’s, the PTAB determined (1) the asserted prior art reference did not anticipate the challenged ‘903 claims (14-693 IPR); and (2) the asserted prior art references did render the challenged claims invalid as obvious (14-752 IPR).

Here, the claims are directed to a dosing regimine of a known drug treating an issue that it was already known to treat.  The particular claims require “a continuous long term regimen . . . at a dosage up to 1.5 mg/kg/day for not less than 45 days” for treating “an individual with … penile tunical fibrosis …”

On anticipation, the court drew a fine-line with its closest case being AstraZeneca LP v. Apotex, Inc. where the Federal Circuit affirmed that method claims for “once-daily dosing would likely survive an anticipation challenge by a prior advertisement that disclosed twice-daily dosing.”  Here, the prior art suggested “chronic administration” of the drug while the patent particularly requires 45 days of dosage.  A close reading of the prior art led the court to limit “chronic” to “daily administration for at least three days” and less than three-weeks (since the prior art’s study only lasted for three weeks).  Affirmed as Not Anticipated.

On obviousness, the PTAB found the claims obvious.  On appeal, however, the Federal Circuit rejected the PTAB’s claim construction of the requirement of treating “an individual with … penile tunical fibrosis.” In particular, the PTAB allowed-in prior art treating erectile dysfunction even if penile fibrosis had not been formally diagnosed.  On appeal, the Federal Circuit held the PTAB’s approach “reads that limitation out of the claim” since ED may have other causes (such as psychological).  Based upon this linguistic argument, the court made the leap that – therefore “it is unreasonable to use the symptom of erectile dysfunction as a proxy for penile fibrosis.”  In the eyes of the court, this distinction eliminated the motivation-to-combine the references since they did not directly address the penile fibrosis issue.

As mentioned above, the majority ordered a remand to the PTAB to make new findings on the motivation to combine.  Judge Newman dissented from that approach – arguing that the PTAB/Lilly had their chance and that the judgment should be final on appeal.

Provisional Priority:  A final note on the case involves LAB’s claim for priority to its early-filed provisional patent application.  As you might expect, the court ruled that it was not entitled to such priority because the provisional did not expressly disclose the claim limitation of 1.5 mg/kg/day.

 

 

Federal Circuit to PTO: EXPLAIN WITH PARTICULARITY AND EVIDENCE

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PersonalWeb Tech v. Apple (Fed. Cir. 2017) [personalweb]

Following an administrative trial, the PTAB found the challenged claims of PersonalWeb’s Patent No. 7,802,310 obvious based upon a combination of two prior art references.  On appeal, however, the Federal Circuit has vacated the judgment – holding that the Board’s factual findings  were not supported by substantial evidence. In particular, the Federal Circuit could not find substantial evidence for the conclusions (1) that the prior art taught each element of the challenged claims or (2) that PHOSITA would have been motivated to combine the references to form the invention as claimed.

Substantial Evidence: For me, the substantial evidence rule is a misnomer because it suggests that a decision is based upon a substantial amount of evidence (and thus seems like a reasonable approach).  I would rename it as the “scintilla rule” because, under the rule, factual conclusions made by the PTAB are affirmed on appeal so long as supported by “more than a mere scintilla” of evidence.  I previously wrote:

[T]o be clear, the appellate court will affirm a factual determination even when that determination is likely wrong so long as some amount of evidence supports the determination. We have all heard the adage that ‘reasonable minds can differ.’ I think of the substantial evidence rule as a relaxed version that ‘somewhat reasonable minds can differ.‘ Or, in other words, the PTO’s factual determinations will be affirmed if somewhat reasonable.

Although the PTAB burden is not great, the Board must fully explain its conclusions and their bases.  (This is a major difference when compared with the ‘black box’ of a jury trial).  As part of its explanation, the Board must also specifically contend with evidence that “detracts from an agency’s decision.”  The court explained in its 2002 Lee decision:

For judicial review to be meaningfully achieved within these strictures, the agency tribunal must present a full and reasoned explanation of its decision. The agency tribunal must set forth its findings and the grounds thereof, as supported by the agency record, and explain its application of the law to the found facts.

In re Lee, 277 F.3d 1338, 1343 (Fed. Cir. 2002).  That is, the Board, “must articulate ‘logical and rational’ reasons for its decision.” (quoting Synopsys).

Here, the court explained that the rational in an obviousness case includes

  1. Particularly identifying where each element of each claim is taught by the prior art references.  Here, the Board failed to explain the particular location within Woodhill that taught the claim limitation of comparing a name with a “plurality of values.” (yes, that’s right.)
  2. Explaining the motivation to combine.

Explaining motivation to combine is a big deal because it comes up in almost every patent case before the PTO. Here, the Board simply wrote that:

“a person of ordinary skill in the art reading Woodhill and Stefik would have understood that the combination of Woodhill and Stefik would have allowed for the selective access features of Stefik to be used with Woodhill’s content-dependent identifiers feature.”

On appeal, the Court found that justification inadequate.

Indeed, the Board nowhere clearly explained, or cited evidence showing, how the combination of the two references was supposed to work. At least in this case, such a clear, evidence-supported account of the contemplated workings of the combination is a prerequisite to
adequately explaining and supporting a conclusion that a relevant skilled artisan would have been motivated to make the combination and reasonably expect success in doing so. . . .

A brief explanation may do all that is needed if, for example, the technology is simple and familiar and the prior art is clear in its language and easily understood. See Ariosa, 805 F.3d at 1365–66. On the other hand, complexity or obscurity of the technology or prior-art descriptions may well make more detailed explanations necessary. Here, the Board’s explanation is wanting. Apple’s attempts in this court to explicate both the Board’s explanation and the underlying evidence do not persuade us otherwise.

On remand, the Board will give it another go – and we’ll see whether the exercise of actually explaining its reasoning causes the Board to change its mind as well.

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My explanation of the case skipped over details of the patent at issue.  Claim 1 is shown below and basically includes three steps: (a) sending a “content based name” for a data-item from one computer to another; (b) check to see if the name is on a list; and (c) grant or deny access to the data-item depending upon the result of (b).

1. A computer-implemented method … comprising the steps:

(a) at a first computer, obtaining a content-based name for a particular data item from a second computer …, the content-based name being based at least in part on a function of at least some of the data which comprise the contents of the particular data item, wherein the function comprises a message digest function or a hash function, and wherein two identical data items will have the same content-based name; and

(b) … a processor at said first computer ascertaining whether or not the content-based name for the particular data item corresponds to an entry in a database comprising a plurality of identifiers; and

(c) based at least in part on said ascertaining in (b), determining whether or not access to the particular data item is authorized.

The patentee claims that Apple’s iTunes and iCloud services infringe.

First Rehearing Request Challenging No-Opinion Judgments

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by Dennis Crouch

LSI v. FLIR (Fed. Cir. 2017) (request for rehearing) [16-1299-leak-surveys-v-flir_combined-rehg]

In its newly filed petition for rehearing, Leak Surveys has asked the Federal Circuit to withdraw its Judgment Without Opinion. Leak’s Counsel (Donald Puckett) argues:

It is hard to imagine an appeal more unsuitable for affirmance without opinion under Fed. Cir. R. 36 than this one.

The petition makes two primary arguments:

  1. If the Federal Circuit’s judgment is based upon new or alternative grounds not stated by the PTAB, then it must write an opinion.  Although the reason for a judgment without opinion are not directly discernible, the petitioner here suggests that it was likely based upon theories first espoused by the court and respondent at oral arguments — sufficient to form a prima facie conclusion that the judgment relied upon new or alternate grounds.
  2. LSI urges the en banc Court to grant rehearing to decide whether this Court can ever affirm a PTAB IPR decision without opinion. See 35 U.S.C. § 141 (in USPTO appeal, Federal Circuit “shall issue to the Director its mandate and opinion . . .”) (emphasis added). See also Crouch, Wrongly Affirmed Without Opinion, Univ. of Missou. L. Stud. Research Paper No. 2017-02, Forthcoming 52 Wake Forest Law Review ___ (2017) (http://ssrn.com/abstract=2909007).

In offering the first weaker option, LSI gives the court an option in case it “may hesitate to open a floodgate of rehearing requests.”  Of course, there are only about a dozen R.36 decisions that are still within the court’s 30-day deadline for requesting rehearing.  (The Supreme Court has a 90-day deadline).  The stronger approach that I argue for: “LSI presents this argument here to preserve it for further appeal to the U.S.
Supreme Court if necessary.”  [Amicus support due within two weeks]

The underlying appeal center on the validity of Leak’s U.S. Patent No. 8,193,496 and 8,426,813 that cover gas-leak detection equipment and methods using a passive-IR camera and bandpass filter.  The primary issues were claim construction (“leak” and “normal operating conditions”) and motivation to combine in the ultimate obviousness conclusion.   The original brief began as follows:

The IPR proceedings below resulted in the creation of a dense factual record involving 24 declarations and 14 depositions. Almost all witnesses were scientists (many with Ph.D. degrees) having personal knowledge of the petroleum industry’s extensive efforts (and failures) to develop a commercially viable imaging system for detecting hydrocarbon gas leaks in the field. Most of these same witnesses also offered first-hand testimony of [the inventor] David Furry’s own efforts to solve the same technical problem. Several witnesses -top scientists from the largest petroleum companies – described the day in 2004 when Furry showed up at the industry’s “Scan Off” to demonstrate his “Hawk” camera against the industry’s then-best optical leak detection systems. These scientists, having dedicated years of work and countless resources to creating a commercially viable optical leak detection system, testified that they were completely surprised and astonished by the Hawk’s unexpected results. It was immediately apparent that Furry had solved an important technical problem that the petroleum industry had been unable to solve.

leaksurveysmeritsbrief

us08193496-20120605-d00001

 

PTAB initiation of PGR Does not Negate Preliminary Injunction

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tinnuspatentby Dennis Crouch

Tinnus Enterprises v. Telebrands (Fed. Cir. 2017) [tinnustelebrands]

In an opinion by Judge Stoll, the Federal Circuit has affirmed an E.D.Texas preliminary injunction barring the accused infringer from selling its “Balloon Bonanza” product “or any colorable imitation thereof.”

I previously wrote about the case that involves Telebrands’ patented balloon-filling-toy. U.S. Patent No. 9,051,066.  The case is one of the first lawsuits involving a post-AIA patent.

Preliminary Injunctive Relief: Even before eBay, courts applied a four-factor test to determine whether to award a preliminary injunction to stop ongoing infringement pending a final judgment in the case. (eBay changed the rule for permanent injunctive relief.).

A decision to grant or deny a preliminary injunction is within the sound discretion of the district court, based upon its assessment of four factors: (1) the likelihood of the patentee’s success on the merits; (2) irreparable harm if the injunction is not granted; (3) the balance of hardships between the parties; and (4) the public interest.

The factors are slightly different than those considered for permanent relief in eBay.  Most importantly, at the pre-trial stage, the patentee has not established that it will actually win the case and be eligible for any remedy at all. Thus, the Preliminary Injunction factors include consideration of who is likely to win.  The Prelminary Injunction factors also eliminate the eBay factor that “remedies available at law are inadequate to compensate for the injury” by rolling that factor into the irreparable harm consideration.  A fifth element that is not usually stated in the test is that the patentee must also be willing and able to post a bond to the court that will compensate the enjoined party if it turns out that the injunction was improper. Rule 65(c) requires a bond “in an amount that the court considers proper to pay the costs and damages sustained by any party found to have been wrongfully enjoined or restrained.” Fed. R. Civ. P. 65(c). Two important aspects on appeal: (1) A district court’s PI order (either grant or denial) is immediately appealable even though it is a non-final interloctutory order. 28 U.S. Code § 1292. (2) Because district courts are given discretion in awarding preliminary injunctive relief, those judgments are given deference on appeal.

PTAB Interplay: As with so many US patent lawsuits, the case involves a parallel AIA-trial. Since the patent at issue here is a post-AIA patent, the challenger was able to file for post-grant-review (PGR).

The timeline is relevant:

  • Patentee files the lawsuit and requests a preliminary injunction.
  • District court awards PI – after considering but rejecting invalidity challenges by defendant.
  • Defendant files PGR petition – making the same invalidity arguments (indefinite and obvious).
  • USPTO initiates PGR – finding claims likely invalid as obvious and indefinite.
  • Defendant appeals court PI.

As noted above, a key factor for awarding preliminary relief is the likelihood that the patentee will ultimately win the case on the merits.  Although a patent is presumed valid, a challenger can overcome this hurdle by showing that the patent is “vulnerable” to a specific validity challenge.  The court has also termed this as finding a “substantial question concerning the validity of the patent.”  A seemingly reasonable approach here would be to say – “If the PTO concludes that claims are likely invalid, then those claims are probably vulnerable to being found invalid.”  Here, the court does not follow that approach and – in fact – does not even mention the PTAB initiation decision in its discussion of the aforementioned vulnerability.  (The court does state that the PTAB has taken action, but does not appear to draw any conclusions for this case from that parallel proceeding).  Implicit holding here is that the PTAB initiation of a PGR Does not negate a preliminary injunction.

Rather, the appellate panel walked through the district court decision and found that (1) someone of skill in the art would likely understand the term “substantially filled” and thus it is not indefinite; and (2) the district court did not err in holding that prior art associated with filling an endoscopic balloon was not analogous or pertinent to the problem of filling toy water balloons.

Preliminary Injunction Affirmed.

= = = =

Motivated to Consider vs Motivated to Combine: The Federal Circuit is still working through how to deal with the analogous arts test post KSR.  Here, the court ultimately found there was no ‘motivation to combine’ the prior art since one of the references was not ‘analogous art.’  In at least pre-KSR tradition, these were separate inquiries within the obviousness process outlined in Graham v. John Deere.  The analogous arts test has long been thought of as part of the initial factual Graham inquiry – identify the scope and content of the prior art.  Under the doctrine as explained in Clay, the court limits the scope of prior art only to references that a worker may have been motivated to consider.  These are generally thought of as references in the same field of endeavor or addressing similar problems as those faced by the inventor.  Of course, just because two prior art references are within the same field does not mean that the worker would have been motivated to combine the elements of references in the way claimed by the inventor.  Thus, traditionally, the motivation to consider a reference is a unique and different inquiry than that of the motivation to combine the elements of multiple references.  Here, the court appears to mix them together in a way that adds to confusion in the inquiry rather than offering clarity.

Now, maybe it makes sense to throw-out the old Graham v. John Deere structured approach, but that should be an explicit process rather than a set of (perhaps-unintentional) undermining decisions.

What it takes to Prove a Motivation to Combine

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by Dennis Crouch

In re NuVasive (Fed. Cir. 2016)

In an important obviousness decision, the Federal Circuit has reversed the PTAB IPR decision – holding that the PTAB failed to sufficiently explain its ruling that a person having ordinary skill in the art (PHOSITA) would have been motivated to combine the prior art teachings to create the patented invention.  Although expressing its intent to follow KSR, the court here comes closer to trodding upon that (oft maligned) precedent.

The case involves an Inter Partes Review (IPR) challenge of NuVasive’s spinal fusion implant patent (U.S. Patent No. 8,361,156).  The claims require that the implants include, inter alia, radiopaque markers on the medial plane. The PTAB found the claims invalid as obvious based upon a collection of prior art references related to spinal fusion.

Doctrine of Obviousness: A claim is invalid if the differences between the prior art and the claim (considered “as a whole”) would have been obvious to PHOSITA considering the issue at the time the invention was made.  35 U.S.C. § 103.

Motivation to Combine: In many US obviousness cases, each of the claim limitations are found in some form within the body of prior art imputed to PHOSITA and the obviousness question becomes whether it would have been obvious to combine those references to form the claimed invention. In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that the motivation to combine references need not be found expressly in the prior art itself but may be explained by the fact finder using common sense.  Still, the KSR Court wrote that it “can be important to identify a reason that would have prompted [PHOSITA] to combine the elements in the way the claimed new invention does.”  Extending that decion, the Federal Circuit ruled that the PTAB must (1) “articulate a reason why a PHOSITA would combine the prior art references”; (2) have an adequate evidentiary basis for that finding; and (3) provide a “satisfactory explanation” for the motivation finding that includes an express and “rational” connection with the evidence presented.  See, In re Lee (conclusory statements are insufficient); Cutsforth v. MotivePower (must positively explain motivation – not just reject arguments against motivation); and Arendi v. Apple (PTAB “cannot rely solely on common knowledge or common sense to support its findings” of motivation).

Here, the basic question is whether it would have been obvious to combine prior art teaching the spinal fusion implant with references showing the use and importance of radiopaque markers in implants.  However, according to the appellate panel, “the PTAB failed to explain the reason why a PHOSITA would have been motivated to modify [the prior art], to place radiopaque markers ‘proximate to said medial plane'” as required by the challenged claims.

After discrediting the PTAB decision, the court also looked at the evidence presented by the challenger Medtronic.  Medtronic’s expert had explained that the motivation for adding the additional markers would be to provide surgens with “additional information” and that it would have been common sense to add the additional markers.

Medtronic’s arguments amount to nothing more than conclusory statements that a PHOSITA would have been motivated to combine the prior art references to obtain additional information.  According to the court, these “arguments amount to nothing more than conclusory statements” and thus should not be credited.  One key reference did explain that the medial markers were beneficial during the alignment process.  However, the Federal Circuit rejected that reference because it was published after the patent-in-question’s priority date and not cited in the prior art references.  Because they came after the priority date, the court found that the motivation “could not have been obtained . . . at the time of the invention.”

Is it Obvious to Combine Five References?

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by Dennis Crouch

On his (great) blog, Bill Vobach considers whether it is time to revisit In re Gorman, 933 F.2d 982 (Fed. Cir. 1991).   Gorman involved an obviousness rejection based upon a combination of thirteen references. The Federal Circuit rejected Gorman’s argument that the combination of a large number of references to support a rejection for obviousness “of itself weighs against a holding of obviousness.” See also, In re Troiel, 274 F.2d 94 (CCPA 1960) (rejecting appellant’s argument that combining a large number of references to show obviousness was “farfetched and illogical”).  The USPTO has regularized this holding within its Manual of Patent Examination Practice (MPEP) Section 707.07(f) (“reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention”).  Of course, when Gorman was decided, the court also required some express motivation in order to combine references — that requirement was eliminated ten years ago by the Supreme Court in KSR v. Teleflex (2007).

I cannot recall any obviousness decision coming out of a district court that combines four or more references.  Neither Judges nor Juries will stand for that level of complexity.  The PTAB judges are so well trained in the complexity of technology and patent law that they are open to these poly-reference arguments in the AIA trial context.

Vobach, who reviews almost all of the Federal Circuit oral argument audio clips, reports that various judges have commented recently on the large number of references being relied upon in obviousness rejections.  Judge Moore most pointedly noting that “four or greater . . . that’s a lot of references!”

Two approaches for moving forward on the issue: (1) preserve the appeal and request en banc hearing; (2) argue that Gorman was reset by KSR.  An unlikely third approach might push Congress to move toward an European approach that begins the analysis with the closest single prior art reference and builds from there.

 

Obviousness does not Require Prior Art to Fit Together Exactly

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ClassCo v. Apple (Fed. Cir. 2016)

In response to being sued for patent infringement, Apple filed for inter partes reexamination of ClassCo’s Patent No. 6,970,695. That litigation (originally filed in 2011) has been stayed pending the resolution here.  Although the patent had survived a prior reexamination, this time the Examiner rejected the majority of the patent claims as obvious; the PTAB affirmed those rejections; and the Federal Circuit has now re-affirmed.

The patent relates to a “caller announcement” system that uses a phone’s speaker (rather than screen or separate speaker) to announce caller identity information.  The system includes a “memory storage” that stores identify information being announced.

The examiner identified the prior art as U.S. Patent No. 4,894,861 (Fujioka) that teaches all of the claimed elements (of representative claim 2) except for use of the phone’s regular audio speaker (rather than a separate speaker) to announce a caller’s identity (claimed as the “audio transducer”).  A second prior art reference was then identified as U.S. Patent No. 5,199,064 (Gulick) that taught the use of the audio transducer for providing a variety of call related alerts.

On appeal, ClassCo argued that the combination of Fujioka and Gulick was unreasonable because it would involve changing the function of the known elements.  The Federal Circuit disagreed writing that:

KSR does not require that a combination only unite old elements without changing their respective functions. . . . Instead, KSR teaches that ‘[a] person of ordinary skill is also a person of ordinary creativity, not an automaton.’ And it explains that the ordinary artisan recognizes ‘that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.

Slip opinion at 8 (quoting KSR).  The court goes on to explain that a combination of known elements can be obvious even the elements don’t fit perfectly together like puzzle pieces.  Rather, the approach is “flexible” in its pursuit of determining whether the combination would have been “predictable” – i.e., obvious.

Although KSR rejected a strict application of a motivation-to-combine, the court consistently required at least an explanation of that motivation.  Here, the court found that “substantial evidence” supports the PTO conclusions since some of the benefits were suggested by both prior art references.

Secondary Indicia: During reexamination, ClassCo had also presented evidence of industry praise for its products covered by the patent.  That evidence was disregarded by the PTO as, inter alia, not commiserate commensurate with the scope of the claims. 🙂 In particular, the Board noted that the industry praised particular embodiments but did not praise other potential embodiments. On appeal, the Federal Circuit rejected those conclusions.  The court found that some of the evidence praised ClassCo features that were not available in the prior art and that were “within the scope” of the representative claims.

[T]he Board found the evidence not commensurate in scope with these claims on the ground that they are too broad, encompassing other embodiments. But “we do not require a patentee to produce objective evidence of nonobviousness for every potential embodiment of the claim.” Rambus. Rather, “we have consistently held that a patent applicant ‘need not sell every conceivable embodiment of the claims in order to rely upon evidence of [objective indicia of nonobviousness].’” In re Glatt Air Techniques, 630 F.3d 1026 (Fed. Cir. 2011) (quoting In re DBC, 545 F.3d 1373 (Fed. Cir. 2008)).

Although the Board erred in its approach to objective indica, that was harmless error since the prior art evidence was strong. “We nonetheless agree that the value this evidence possesses in establishing nonobviousness is not strong in comparison to the findings and evidence regarding the prior art under the first three Graham factors.”  Obviousness affirmed.

Although a different product, the following ClassCo video review is a fun throw-back:

DuPont v. MacDermid Printing: The importance of a Patentee’s Pre-Filing Statements

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by Dennis Crouch

A skilled patent attorney working with a qualified searcher could cobble together a colorable obviousness argument against the vast majority of issued patent claims.  Part of the difficulty for patentees stem from the the billions of prior art references available via increasingly effective search tools. Even when an invention results from a ‘flash of genius,’ patent law typically back-fills extensive knowledge for the obviousness analysis – even when that knowledge was not actually available at the time of the invention.  The larger difficulty though is likely the large number of hard-to-pin-down facts such as the motivations, common sense, and level of creativity of a person having ordinary skill in the art.

The “expansive and flexible” approach to nonobviousness is frustrating to many, but it is seen as a feature of the system fully supported by the Supreme Court.  In KSR, the court wrote:

Throughout this Court’s engagement with the question of obviousness, our cases have set forth an expansive and flexible approach. . . . Rigid preventive rules that deny fact finders recourse to common sense… are neither necessary under our case law nor consistent with it.

KSR v. Teleflex (2007) [04-1350].  Conventional wisdom post-1980 has been that the factual inquiry makes summary judgment of obviousness difficult for a patent challenger.  Rather, obviousness goes to the jury.  Since KSR, that attitude has shifted somewhat.  (The even newer model is that obviousness goes to the PTO in an IPR proceeding – save that for a different essay).

= = = = =

Summary Judgment of Obviousness: In DuPont v. MacDermid Printing (Fed. Cir. 2016) [15-1777], the NJ district court granted summary judgment of obviousness against the patentee DuPont – holding that the asserted claims of DuPont’s U.S. Patent 6,773,859 invalid under 35 U.S.C. 103.   The ‘859 patent relates to the manufacture of  a flexo plate for digital printing — a plate used to print digital images on flexible materials.   The claimed advance involves heating-up the plate to remove unpolymerized material (rather than using a harsh solvent).

The obviousness case combines two prior art references: “Martens [a 3M patent] teaches a process for developing an analog plate using heat” and “Fan [DuPont patent] teaches developing a digital plate using solvents.”   The inventor (Roxy Fan) is also the first named inventor of DuPont’s ‘859 patent being challenged in this case. The Fan prior-art patent, however, was filed a decade prior.  Reviewing these two references, the court found that the ‘859 patent uses “the same technology and processes pertaining to digital imaging” previously disclosed by Fan and the same thermal development process disclosed in Martens.  In finding a motivation-to-combine these references, the district court walked through several factors.

  • Limited set of potential combinations: The prior art only had two imaging styles (digital and analog) and four development techniques (thermal, etc.) – this makes the ‘859 combination more likely obvious to try.
  • Benefits of Moving to Digital: The prior art taught benefits of switching to digital (thus suggesting the substitution), including an article published by DuPont
  • Market Incentive: DuPont marketing material suggest a “strong incentive” to combine the thermal process with digital plates.

The district court also rejected DuPont’s evidence of commercial success, longfelt need, and industry praise – finding them insufficient to overcome the “strong showing of obviousness.”

On appeal of this summary judgment finding, DuPont focused on the standard-of-review – noting that the district court had failed to “draw reasonable inferences” in its favor.  In the process, DuPont pointed to a long list of factual disputes between the parties where it would be reasonable to draw different conclusions from the evidences.

The Federal Circuit affirmed – finding that the strong undisputed evidence of prior art and motivation to combine fully supported the summary judgment finding.

[T]he record contains strong evidence that a skilled artisan would have had a reason to combine two known technologies and would have had a reasonable expectation of success in doing so. Indeed, DuPont itself promoted the digital and thermal technologies as technological breakthroughs in prior art publications. Thus, in view of the record as a whole, even drawing all justifiable inferences in favor of DuPont, the objective evidence is insufficient to preclude summary judgment on the ultimate legal conclusion of obviousness.

Doomed by Its Own Prior Statements: The obviousness case against DuPont here is interesting because (1) one of the core prior art references was a DuPont reference and (2) DuPont’s own statements regarding its prior inventions led to the motivation-to-combine finding.  DuPont’s private case study will likely walk through and consider whether it should have taken a different pathway regarding the public disclosures.

Caveat: Although the patentee’s pre-filing disclosures are important – it is also important to remember that the question of obviousness is an objective analysis focusing on the hypothetical mind of a person having ordinary skill in the art.  What this means is that the patentee’s disclosures are should not be treated as “party admissions” and given special treatment in the obviousness analysis.  Rather, the disclosures are simply added to the body of knowledge available to the artisan.  Here, the Federal Circuit came dangerously close to crossing the line into giving information actually available to and created by DuPont special weight in the obviousness analysis.

 

Obviousness of the New Mixture

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Apotex v. Wyeth[1] is a relatively simple and straightforward nonobviousness decision in the pharma space (albeit non-precedential).  The Wyeth patent at issue here claims the compound that includes tigecycline mixed together with an acid as well as lactose.[2]  Although not claimed, the specification indicates that the mixture is beneficial because it helps tigecycline avoid degradation.  At the time of the invention (2005) tigecycline was a known tetracycline known to act as a broad spectrum antibiotic that degrades rapidly at a neutral PH.

The key prior art in the obviousness case was a Chinese patent publication that discloses minocycline mixed with both lactose and an acid in order to avoid degradation.[3]  Minocycline is a closely related tetracycline that is both structurally similar and operates by similar action.  (Tigecycline is a derivative of minocycline).

In both the Inter Partes Review proceedings and the appeal, the courts found insufficient motivation to combine the cited references by substituting the tigecycline into the minocycline compound.  Importantly here, the courts made this determination as a factual finding that “a skilled artisan would [not] have had a reason to combine the references.”[4]

Apotex (the challenger) argued that the similarity between the two forms of tetracycline and the fact that tigecycline was “known to work where other antibiotics have failed” both pushed toward a finding of a motivation to combine.  The courts however rejected this argument – finding that the structural similarities did not create “a potential motivating factor for a skilled artisan to substitute tigecycline for minocycline.”

[W]hile tigecycline is closely related to minocycline structurally and in terms of benefit, the Board did not err in concluding that there was insufficient basis in the record to show that it would have been obvious to a skilled artisan to substitute tigecycline in the prior art minocycline composition.

Although not mentioned by the courts, I would think it would also be important motivation to consider that – at the time of the invention here – tigecycline was not just some random minocycline derivative – rather tigecycline was being considered as an important last-resort MRSA treatment and under consideration for fast-track FDA approval.

= = = = =

A first thought that comes to my head in this case is whether the outcome here stems from the fact that this is a pharmaceutical case rather than one focusing on electronics or mechanical engineering.  Perhaps not, the court does explain here the lack of assurances (pre-invention) that the claimed mixture would substantially reduce degredation.  That factual-setup can be distinguished from a case like KSR where a good engineer could give pre-assurances that they could get the combination to work.

= = = = =

One aspect of the decision involves underlying distinctions between the ultimate question of obviousness (an issue of law) and the factual underpinnings (such as  motivation to combine references).  Here, of course, once the facts were determined, the question of law was instantly answered.

= = = = =

Notes:

[1] Apotex Inc. v. Wyeth LLC, App. No. 15-1871 (Fed. Cir. August 16, 2016).

[2] U.S. Patent No. 7,879,828, claim 1 taken as typical.

[3] Chinese Patent Pub. No. 139055A.

[4] See In re Hyon, 679 F.3d 1363 (Fed. Cir. 2012).

The Limited Role of Common Sense in the Obviousness Analysis

Patent,

by Dennis Crouch

Decisions by the Patent Trial & Appeal Board are rarely overturned on appeal.  I expect that result is largely due to the fact that the Patent Office has staffed the Board with highly trained and skilled patent law experts.  The other important factor though, is the standard of review.  Factual findings made by the Board are reviewed for “substantial evidence” — meaning that the findings need not be “correct” but rather rather merely supported by “more than a mere scintilla of evidence.”  Thus, patentees are hard-pressed to get a reversal based upon erroneous factual conclusions.  (For a counter-example, see In re Warsaw Ortho (Fed. Cir. 2016).

In the new decision captioned Arendi S.A.R.L. v. Apple Inc., Appeal No. 15-2073 (Fed. Cir. 2016) [ArendiApple], the court has reversed the Board – finding an erroneous application of the law.  This approach to an appeal tends to work better – because issues of law decided by the PTAB are ordinarily reviewed de novo on appeal (except where the agency’s interpretation is given deference).

The holding:

Because the Board misapplied our law on the permissible use of common sense in an obviousness analysis, we reverse.

The software patent at issue involves a identifying a key in a document (such as a person’s name) and then searching a separate data-source for further information on that key. U.S. Patent No. 7,917,843 (claiming 1998 priority).

Single Reference Plus Common Sense: In its obviousness decision, the Board identified a single prior art reference (Pandit) that teaches the recognition of text classes (such as phone numbers) and then providing additional suggestions based upon that recognition (such as dial, add to contacts, etc.).  However, Pandit did not expressly teach a search of the separate data-source.  In concluding that the invention was obvious, the Board found that it would have been “reasonable . . . common sense” that Pandit would search through the contact list for the phone number before actually adding a new contact number. The board wrote:

[I]t would have been obvious to the ordinary artisan to utilize a computerized search for duplicate telephone entries when entering a telephone number in an electronic address book database as taught by Pandit.

In making its determination, the Board held that common sense must be applied throughout the obviousness analysis, and not only when combining references that disclose all the required limitations.

On appeal, the Federal Circuit rejected the Board’s analysis – holding that Common Sense must be confined to its “proper place in the obviousness inquiry.” (I expect that this line from the opinion is one that will likely upset members of the Supreme Court because it is ridiculous.).

Caveats to Common Sense: In confining the use of common sense, the Federal Circuit identified three “caveats” to its use:

  1. “First, common sense is typically invoked to provide a known motivation to combine, not to supply a missing claim limitation.”
  2. Second, when common sense is used to supply a missing claim limitation, it should only apply where the missing limitations is “unusually simple and the technology particularly straightforward.”
  3. “Third . . . common sense . . . cannot be used as a wholesale substitute for reasoned analysis and evidentiary support, especially when dealing with a limitation missing from the prior art references specified.”

Although not listed specifically as a caveat, the court also discussed a fourth – that statements of common sense or general knowledge cannot overcome “important” claim limitations without supporting evidence.

Question of Substantial Evidence: Stepping back from these broad statements of law, the court partially reforms its opinion to the proper question –  “whether there was substantial evidence supporting the Board’s finding that common sense would lead one to search for the telephone number in Pandit.”  In the appeal, the Federal Circuit found that no evidence had been presented regarding the common sense conclusion but rather only attorney argument. “Specifically, Appellees have failed to show why it would be common sense for the ‘Add to address book’ function to operate by first ‘search[ing] for entries with the same telephone number.'”

To be clear – I am 100% on board here – that an obviousness finding must be supported by evidence.  Unfortunately, that is not what the Supreme Court appeared to rule in KSR v. Teleflex — where it suggested that “analysis” can do the trick.

= = = = =

Arendi has infringement cases pending in Delaware against Blackberry, Motorola, Google, Apple, Sony, Nokia, HTC, Yahoo!, Samsung, and LG.  Arendi is a Luxembourg patent owner created by the ‘843’s Norwegian inventor Atle Hedløy.

USPTO’s Six New Patent Quality Studies

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1) Evaluation of the deviation of 35 U.S.C. §101 rejections from official guidance, correctness of rejections and completeness of the analysis. This study will evaluate whether examiners are properly making subject matter eligibility rejections under 35 U.S.C. §101 and clearly communicating their reasoning.

2) Review of consistency of the application of 35 U.S.C. §101 across art units/technology centers. This study will take a look at applications with related technologies located in different art units or technology centers and determine whether similar claims are being treated dissimilarly under 35 U.S.C. §101.

3) The practice of compact prosecution when 35 U.S.C. §101 rejections are made.  This study will determine whether all appropriate rejections are being made in a first Office action when a subject matter eligibility issue is also identified.

4) Correctness and clarity of motivation statements in 35 U.S.C. §103 rejections. This study will evaluate whether reasons for combining references set forth in rejections under 35 U.S.C. §103 are being set forth clearly and with correct motivation to combine statements.

5) Enforcement of 35 U.S.C. §112(a) written description in continuing applications. This study will evaluate claims in continuing applications to determine if they contain subject matter unsupported by an original parent application and whether examiners are appropriately enforcing the requirements of 35 U.S.C. §112(a) written description.

6) Consistent treatment of claims after the May 2014 35 U.S.C. §112(f) training. This study will determine whether claims invoking 35 U.S.C. §112(f) are being properly interpreted and treated.

http://www.uspto.gov/blog/director/entry/topics_announced_for_case_studies

 

Shining a Light on Obviousness

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In re Cree (Fed. Cir. 2016)[1]

In a straightforward decision, the Federal Circuit has affirmed the PTAB’s decision that Cree’s claimed down-shifted LED invention would have been obvious in light of a combination of three prior art patents.[2]  The basic problem with LED lighting is that it is easy and cheap (these days) to get blue light, but harder to produce light across the spectrum – especially reds.  Cree’s patented approach used a blue LED that is wrapped in a “down-converting luminophoric medium.”  The basic idea is that the blue light energy is absorbed by the medium and then released as white light.  These Fluorescent and phosphorescent materials were already known and commercially available.

The Federal Circuit decision affirming the Board is a demonstration of flexibility of the contemporary obviousness doctrine.  With each of Cree’s attempts to poke holes in the Board’s decision, the Federal Circuit offers an annealing response that make Cree’s arguments seem weak.

Particular holdings:

  1. The PTAB did not err by adopting the patent examiner’s findings rather than writing its own. “There is no force to that argument. It is commonplace in administrative law for a reviewing body within an agency to adopt a fact-finding body’s findings.”
  2. The PTAB’s statements of items “known” in the art did not require a single prior art reference disclosing that knowing. “In context, it is clear that the Board was not using the word ‘known’ to mean ‘disclosed in a single reference.’ Instead, the Board’s statement that down-conversion was a known approach for creating white light from an LED is best understood to mean that persons of skill in the art were aware that down-conversion could be used to make white light out of blue light, regardless of the source of the light.”
  3. A rational, non-hindsight reason for combining the references comes from the references themselves since the later reference offered a brighter LED that could be combined with the earlier to produce higher quality light. “The availability of the high-powered Nakamura LED thus provided the motivation to combine Stevenson’s use of LEDs to create primary colors with Pinnow’s use of a short-wavelength light source to create white light. . . . [Cree’s] accompanying ‘impermissible hindsight’ is essentially a repackaging of the argument that there was insufficient evidence of a motivation to combine the references.”
  4. Cree’s secondary considerations were insufficient to outweigh strong evidence of obviousness. “[S]elfserving statements from researchers about their own work do not have [much] reliability.” Regarding licensing, “Cree … provided press releases evidencing that it … entered into licensing transactions, but [did] not shown that the licenses were based on the merits of the ’175 patent.”  Further, commercial success of a product only operates as a secondary consideration of nonobviousness if coupled with a nexus between that success and the claimed features of the patent.

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[1] This case is on appeal from the Patent Trial & Appeal Board’s ruling in ex parte reexamination No. 90/010,940.

[2] The referenced prior art includes U.S. Patent No. 3,691,482 (“Pinnow”), U.S. Patent No. 3,819,974 (“Stevenson”), and U.S. Patent No. 5,578,839 (“Nakamura”).

IPR Appeal: Federal Circuit Tells PTAB to Reject More Claims

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Belden v. Berk-Tek (Fed. Cir. 2015) on appeal from IPR2013-00057 (Patent Trial & Appeal Board) .

In an inter partes review appeal, the Federal Circuit has sided with the patent challenger – finding that the PTAB had erred by upholding the patentability of two of Belden’s claims.  This case is important largely for its result. The case is also one to be studied for some attempt to tease out the Federal Circuit’s purported legal analysis.

In the IPR of U.S. Patent No. 6,074,503, the PTAB cancelled claims 1-4 as obvious over a combination of prior art references but upheld claims 5-6.  In this process, the Federal Circuit must give substantial deference to PTAB factual findings (such as the factual underpinnings of the obviousness analysis) but reviews questions of law (such as the ultimate determination of obviousness) de novo on appeal.  Thus, all other things being equal, it is a much less daunting process to base your appeal on an issue of law rather than upon a factual dispute.

In reversing the PTAB’s decision upholding claims 5-6, the Federal Circuit wrote that the Board’s “contrary finding rests on legal errors.”  However, the analysis in the analysis that followed, the court appeared to point out a series of incorrect factual conclusions and perhaps suggests that ‘motivation to combine’ should truly be considered a question of law rather than of fact.

There is no meaningful dispute here, and the Board did not deny, that the two pieces of prior art in combination teach or suggest the methods of claims 5 and 6. The dispute concerns motivation to combine. The Petition and the Institution Decision reveal the two related ways in which that issue was presented and considered: whether a skilled artisan would substitute the twisted pairs of CA ’046 into the method of JP ’910; alternatively, whether a skilled artisan making the cable of CA ’046 would look to the JP ’910 method to make it. The brief discussion in the Petition suggests both views of the matter. …

As the Board found, it is “undisputed that CA ’046 discloses ‘a helically twisted cable.’” There is no dispute that the twisted pairs in CA ’046 need to fit into the notches of (i.e., be aligned with) the separator, as shown in the two figures from CA ’046 reproduced above, for the resulting cable to be made. And the Board correctly recognized in its discussion of claims 1 and 2 that JP ’910 clearly teaches the importance of aligning conductors with a separator (core), and suggests doing so with a die to prevent twisting of the separator, before they are all bunched together for twisting in a stranding device. That evidence points clearly toward a motivation of a skilled artisan to arrive at the methods of claims 5 and 6 based on JP ’910 and CA ’046, as the Board reasoned in its preliminary determination in the Institution Decision.

None of the Board’s reasons for concluding otherwise in its Final Written Decision withstands scrutiny through the lens of governing law. The Board’s first reason was that JP ’910 shows only conductors that are not individually insulated, so that “one of ordinary skill…would not have been motivated … simply to substitute twisted pairs of insulated conductors for the bare metal conductors.” But JP ’910 plainly discloses the need to align the conducting wires with the core and how to do so, as the Board recognized in its analysis of claims 1 and 4. The alignment problem and solution do not depend on whether the wires are insulated. The Board’s disregard of the insulation-independent alignment teaching of JP ’910 violates the principle that “[a] reference must be considered for everything it teaches by way of technology and is not limited to the particular invention it is describing and attempting to protect.” EWP Corp. v. Reliance Universal Inc., 755 F.2d 898, 907 (Fed. Cir. 1985) (emphases in original); see In re Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012). . . .

The Board, returning to its focus on insulation of individual conductors, further reasoned: “Berk-Tek also has not explained why a person of ordinary skill in the art would have had sufficient reason to use the final jacketing/extrusion step of JP ’910, which serves to insulate electrically the bare-metal conductors of JP ’910, to manufacture a cable comprising twisted pairs of individually insulated conductors that do not require additional electrical insulation.” The Board found no answer to Belden’s statement that the final jacketing step, if the conductors themselves were insulated, would be “‘redundant.’ ” But that logic misconstrues the claim language and overlooks on-point evidence. . . .

In short, the record is one-sided on the proper question of whether JP ’910 taught a solution to the problem of aligning cable components that a skilled artisan would have been motivated to use in making CA ’046’s cables. The Board erred in determining that Berk-Tek had not proven the obviousness of the methods of claims 5 and 6 of the ’503 patent by a preponderance of the evidence.

Read the decision here: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1575.Opinion.11-3-2015.1.PDF.

 

No Motivation to Make a Worse Product – Therefore Patentable?

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by Dennis Crouch

Spectrum Pharma and the University of Strathclyde v. Sandoz Inc. (Fed. Cir. 2015)

In this case the Federal Circuit shoots down two fairly silly arguments, but not without first giving them full credence and consideration.  Although the patentee lost here, the Federal Circuit appears to agree with the patentee that its less-pure compound could have been patentable over a purer version identified in the prior art even though the added impurities provided no benefit, functionality, or synergy — PHOSITA simply would not have been motivated to make the less-pure version.

Background: The ANDA lawsuit here centers around Strathclyde’s patent (licensed to Spectrum) covering the the drug Fusilev aka l-leucovorin and Sandoz’s related generic drug application.  The drug leucovorin was found to be effective at treating iron deficiency that can occur with 5-FU cancer treatment. Later, researchers discovered that it was actually one isomer of leucovorin (6S) that was effective and the other isomer (6R) was just along for the ride. The patentee here substantially purified the 6S isomer and attempted to patent it as part of a therapeutic composition.  Claim 1 requires “a mixture of (6S) and (6R) diastereoisomers and consists of at least 92% by weight of the (6S) diastereoisomer, the balance of said compound consisting of the (6R) diastereoisomer.”  It turns out that years earlier a researcher had manufactured a pure form of the 6S isomers and the 50/50 mixture of 6S/6R isomers was known as well. By the time of the invention in question here it was also known that the 6S isomer was the effective one. Later studies proved that the substantially pure form was clinically no better than the 50/50 mixture having the same effective amount of  the 6S isomer.

Obviousness:

A patent claim is invalid as obvious if an alleged infringer proves that the differences between the claims and the prior art are such that “the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art.” 35 U.S.C. § 103(a) (2006) (pre-AIA). Obviousness is ultimately a conclusion of law premised on underlying findings of fact, including the scope and content of the prior art, the differences between the claimed invention and the prior art, and the level of ordinary skill in the pertinent art. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007); Graham v. John Deere Co., 383 U.S. 1 (1966). “The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact.” Alza Corp. v. Mylan Labs., 464 F.3d 1286 (Fed. Cir. 2006). In addition to common knowledge or teachings in the prior art itself, a “design need or market pressure or other motivation” may provide a suggestion or motivation to combine prior art elements in the manner claimed. Rolls Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010);

Here, the patented mixture could be made by simply mixing the known pure 6S isomer with the 50/50 mixture so as to reach the claimed 92% ratio.  The patentee argued that there would have been no motivation to combine these references — going from a pure substance to a less-pure substance. The Federal Circuit sees merit in that argument:

[I]f the pure material is known, no reason has been shown why one would want to have an impure material. Although one may not be motivated to obtain an impure material and, in effect, it therefore can be argued to have been nonobvious—which is Spectrum’s position here, that the 92–95% pure material was nonobvious over the known pure material.

 

 

The Federal Circuit ultimately rejected that argument “despite its superficial appeal” by looking at the patent from the starting point of a 50/50 mixture – and finding that there would have been a motivation to improve its purity.  The court also noted that the new mixture offered no “unexpected advantages over the prior art pure material, the less-than-pure material, and any others of similar concentration.”  In essence, this case is can be seen as very much parallel to KSR – where a combination of two known elements, with each element being used as expected, is unlikely to be patentable absent some unexpected results or synergy.

Objective Post-Invention Evidence Showing Obviousness: Of interest, the Federal Circuit approved of two additional bits of evidence that occurred post-invention that helped prove obviousness. The first was evidence that several other researchers were able to obtain the 92% isomer concentration shortly after the patentee obtained its results — that appears have provided some evidence of obviousness.  Secondly, the court relied upon post-invention studies showing no benefit of the pure drug to negate any synergy  argument.

Infringement by Importation: A second set of claims included a limitation that the composition was provided in “a quantity at least sufficient to provide multiple doses of said mixture of (6S) and (6R) diastereoisomers in an amount of 2000 mg per dose.”  Although Sandoz was planning to sell drug in single-use vials of ~200 mg per dose, the patentee argued that Sandoz did plan to import the drug in larger shipments and, at that importation would be infringing.  The Federal Circuit rejected that argument – finding that the ANDA infringement inquiry under 271(e)(2) “focuses on a comparison of the asserted patent claims against the ANDA product that is likely to be sold following FDA approval.” Thus, the fact that Sandoz plans bulk-imports does not create liability.

On this front, it seems that the Federal Circuit may have left open the possibility that Sandoz imports may still infringe under 271(a) once the generic maker begins imports.

Doctrine of Equivalents: The patentee had argued for infringement under the DOE even though it had narrowed the very amount element during prosecution.  Its argument was that the amendment should not count as narrowing because other claims in the patent were still broader.  That argument fell on deaf ears:

[B]y claim amendments and distinguishing statements on the prior art during prosecution, Spectrum is now estopped from invoking the doctrine of equivalents to prove infringement. When submitting an amendment with the application claims that eventually issued as claims 5–9, the applicants asserted that the newly added claims “include specific limitations as to quantities of materials,” and distinguished the prior art by pointing to the “quantities of these specific mixtures specified in the claims.” Those claims were also added following an office action rejecting the previous original claims as obvious in view of Rees. The applicants again explicitly highlighted the significance of the dosage limitation during an appeal to the Board, their brief stating that the claims “require a minimum of four grams,” the “quantity limitations set forth in the claims” which “define an aspect of the invention that is of great practical significance.” The applicants unequivocally argued that Rees, which allegedly only produced experimental quantities, “do[es] not teach, suggest, or otherwise render obvious the claimed compositions in the quantity specified” in the application claims that became claims 5–9. Those statements are clear and unmistakable expressions of the applicants’ intent to surrender coverage of quantities of the compound in lower doses.

Thus, Sandoz wins here on all fronts.

 

Obviousness: Despite KSR, Still Tough to Win in Court

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Ivera Medical v. Hospira (Fed. Cir. 2015)

On summary judgment, the district court found Ivera’s asserted patent claims invalid as obvious under 35 U.S.C. § 103. On appeal, the Federal Circuit has reversed – finding that Ivera’s submitted expert testimony raised genuine issues of material fact.

Ivera’s patents are directed to a more reliable mechanism for disinfecting connectors (such as an IV port).  The idea is basically a screw-on cap full of disinfectant.  

The patented cap at issue here is an improvement on the original idea found in several prior art references. In particular, Ivera added a vent in the cap “to allow evaporation of the cleaning agent from the inner cavity and to inhibit a buildup of pressure in the cap when the cleaning material is compressed by the site of the medical implement.”

Although the primary prior art reference (Hoang) did not disclose the vent limitations, the district court found – as a matter of law on summary judgment – that a person of skill in the art would have recognized the need for a vent to relieve pressure.  I suspect that the district court was swayed by the fact that the patent is also under final-rejection in an inter partes reexamination based upon the same prior art reference.  On appeal, the Federal Circuit found that the facts were not so clear.

Law of Obviousness:

“A party seeking to invalidate a patent on obviousness grounds must demonstrate by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327 (Fed. Cir. 2014). Determining whether one of ordinary skill in the art would have been motivated to combine the teachings of different references is a flexible inquiry, and the motivation is not required to be found in any particular prior art reference. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).

Here, the evidence before the district court included declarations from Huang (the inventor of the prior art) and others explaining how the Ivera idea was a significant invention because it broke with the conventional wisdom of having a fluid tight seal.  The appellate court saw these submissions as sufficient to raise a genuine dispute of fact that cannot be resolved on summary judgment.

The panel also noted in passing that the examiner during the inter partes review had refused to consider the same declarations because they were filed late in the process — leading to the implication that – if filed earlier – the declarations might have changed the examiner’s viewpoint. The examiner’s reexamination decisions have been appealed to the PTAB and are awaiting judgment.

This case again highlights the power of expert evidence to explain the invention within the context of the prior art.

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I should also note Ivera has a separate infringement case going against Hospira for another cap patent. In that case, the PTAB instituted an IPR (brought by another defendant) that case was settled before final judgment.  In a recent determination, the district court ruled on motion-in-limine to exclude evidence of the PTAB’s decision to institute the inter partes review – finding that it has “little probative value” and “would be confusing to the jury and prejudicial.” [OrderInLimine]

 

 

Hughes on Obviousness: The Problem Motivates the Solution

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by Dennis Crouch

Dome Patent v. Michelle Lee in her capacity as Director of the USPTO (Fed. Cir. 2015)

Patent No 4,306,042 issued in 1981 and expired in 1998, but is still being litigated.  The patent covers a method of making oxygen-permeable material used for contact lenses. Back in December 1997, the patent owner (Dome) sued a set of defendants for infringement.  That lawsuit has been stayed since 1999 pending resolution of an ex parte reexamination requested by one of the defendants. In a 2006 final ruling, the USPTO confirmed patentability of claims 2-4, but cancelled claim 1 as obvious.  Dome then filed a civil action in DC challenging the PTO ruling. That case – filed in 2007 – concluded in July 2014 with the district court’s de novo determination that claim 1 was obvious over a combination of three prior art patents.  On appeal here, the Federal Circuit has affirmed that ruling – finding that “district court did not commit reversible error in its determination that the claimed subject matter would have been obvious to a person of ordinary skill during the relevant time period.”  Judge Hughes penned the opinion that was joined by the two other panel members, Judges Reyna and Schall.

In typical close cases, each of the major elements of a claimed invention are found in a collection of prior art — leaving the question of whether the combination as claimed would have been obvious to a person of ordinary skill in the art.   An important intermediary factual question is whether there is any evidence showing why a skilled artisan might or might not be inclined to combine the references.   In the Supreme Court’s KSR decision, the Supreme Court indicated that the motivation question involves an ‘expansive and flexible’ analysis and can consider the common sense of the skilled artisan.  Citing KSR, Judge Hughes writes:

If all elements of a claim are found in the prior art, as is the case here, the factfinder must further consider the factual questions of whether a person of ordinary skill in the art would be motivated to combine those references, and whether in making that combination, a person of ordinary skill would have had a reasonable expectation of success.

Evidence of a motivation to combine prior art references may flow from “the nature of the problem to be solved.”  Here, the district court found that the motivation came from the prior art evidence indicating a search for high oxygen permeability in contact-lens materials. That finding was then affirmed on appeal: “This understanding would have motivated a person of ordinary skill to combine the Tris monomer disclosed in Gaylord with the Tris-type cross-linking agent disclosed in Tanaka to increase the oxygen permeability of a contact lens.”  There was also some amount of teaching away (the non-Tris prior art outlined the problems of using Tris), but the appellate court affirmed the obviousness finding.

It was important for the appeal here that the ‘motivation’ found by the district court was seen as an issue of fact — a subset of some unnamed Graham factor — rather than a question of law.  Thus, although the appellate court may have disagreed with some aspects of the original decision, the district court’s findings were not “clearly erroneous.”

 

Review of Civil Action: As I mentioned above, the case began as a reexamination and, after losing, the patentee filed a civil action in district court who reviewed the case de novo.  Under i4i, a court patent may only invalidate a patent after being presented with clear and convincing evidence proving that result. See also 35 U.S.C. 282(a) (“In General. – A patent shall be presumed valid.”).  On the other hand, the USPTO operating in reexamination mode only requires a preponderance of the evidence to render the claims null and void.  These competing standards came to a head in the civil action challenging the reexamination finding.  On appeal here, the Federal Circuit affirmed that in this situation only a preponderance is necessary. 

“‘[A reexamination] is in essence a suit to set aside the final decision of the board.’ Fregeau v. Mossinghoff, 776 F.2d 1034 (Fed. Cir. 1985).

[I]f the Patent Office decides after an ex parte reexamination that a preponderance of the evidence establishes the claimed subject matter is not patentable, § 145 authorizes the district court to review whether that final decision is correct. The § 145 action in such a case does not concern the different question of whether, as part of a defense to an infringement action, clear and convincing evidence establishes that an issued and asserted patent should be held invalid.

Somewhat oddly, the court ruled that Section 282 does not apply here because that section only relates to defenses in patent infringement litigation. “The § 145 action before the district court did not involve a defense to a charge of infringement of an issued patent. Section 282 therefore does not apply in this instance.