Tag Archives: reasonable expectation of success

Pending En Banc Petitions at the Federal Circuit

by Dennis Crouch

The Federal Circuit recently decided the en banc design patent case of LKQ v. GM, but the court has not issued an en banc decision in a utility patent case since 2018.  There are currently four interesting petitions pending before the court.

Brumfield – Consistency and Proving International Damages: The Federal Circuit panel affirmed the district court’s grant of summary judgment that the asserted claims of the two asserted patents are invalid under 35 U.S.C. § 101. Brumfield v. IBG LLC, No. 2022-1630 (Fed. Cir. Mar. 27, 2024).  Although the Federal Circuit had previously held that the claimed invention was “technological,” the court here concluded that it was not bound by that prior non-precedential decision. In the petition for rehearing, Brumfield argues the improperly disregarded the Federal Circuit’s prior finding that the patents claim technological improvements.  The contention here is that “the interest of consistency would be ‘ill served'” by allowing different panels to make contradictory findings about the same patent claims.” See, Burke, Inc. v. Bruno Indep. Living Aids, Inc., 183 F.3d 1334 (Fed. Cir. 1999). Id.

The panel also affirmed the district court’s exclusion of Brumfield’s damages expert’s testimony on obtaining foreign damages based on IBG’s domestic making of the accused product. The panel held that although the Supreme Court’s WesternGeco  decision permits awarding damages based on foreign conduct in cases involving domestic infringement, the expert had failed to establish the required causal relationship between the domestic infringement and the foreign conduct. In the rehearing petition, Brumfield argues the improperly decided this fact-intensive causation issue sua sponte, depriving Brumfield of the opportunity to present evidence on an issue that IBG never disputed below or on appeal. [Note: I was involved in litigating patents from this patent family when owned by the predecessor-in-interest. I am no longer involved the litigation. DC]

Edwards Lifesciences – Expanded 271(e)(1) Safe Harbor: In Edwards Lifesciences Corp. v. Meril Life Sciences Pvt., a split Federal Circuit panel affirmed the district court’s summary judgment that Meril’s importation of its transcatheter heart valve fell within the safe harbor provision of 35 U.S.C. § 271(e)(1) and thus, did not infringe Edwards’ patent. No. 2022-1877 (Fed. Cir. Mar. 25, 2024). The majority held that the safe harbor applied because Meril’s importation was “reasonably related to submitting information to the FDA,” even though there was evidence of other commercial uses. The dissent argued that the majority perpetuated the court’s failure to give meaning to the word “solely” in the statute, which cabins the safe harbor to uses solely related to the federal regulatory process. Section 271(e)(1) states that it “shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

Edwards has now petitioned for en banc rehearing, arguing that the panel decision vastly expands § 271(e)(1)’s safe harbor by reading the term “solely” out of the statute, in contravention of the provision’s plain text, history, and purpose. According to Edwards, any non-regulatory use is disqualifying under the correct reading of “solely.” Edwards contends the panel was bound by circuit precedent incorrectly holding that once a defendant identifies any use reasonably related to FDA approval, the safe harbor applies regardless of other non-regulatory uses. (citing AbTox, Inc. v. Exitron Corp., 122 F.3d 1019 (Fed. Cir. 1997)).

Edwards argues this precedent flouts the statutory text and history showing Congress struck a “careful balance” in § 271(e)(1) to allow infringement only for the singular purpose of seeking regulatory approval. By judicially rewriting this compromise to protect non-regulatory and commercial conduct, Edwards claims the Federal Circuit has distorted the market for patented products, undermined the patent bargain, and created a powerful statutory immunity ripe for abuse.

Salix Pharms – Improper Appellate Obviousness Fact Finding: The Federal Circuit recently affirmed the district court’s judgment that several claims of Salix’s patents covering methods of treating irritable bowel syndrome with diarrhea (IBS-D) using rifaximin were invalid as obvious. Salix Pharms., Ltd. v. Norwich Pharms. Inc., 2022-2153 (Fed. Cir. Apr. 11, 2024). Salix has petitioned for rehearing en banc, arguing that the panel majority improperly found facts in the first instance rather than reviewing and analyzing the district court’s fact-finding as required by precedent. See Icicle Seafoods, Inc. v. Worthington, 475 U.S. 709 (1986); Atl. Thermoplastics Co. v. Faytex Corp., 5 F.3d 1477 (Fed. Cir. 1993).

The petition contends that after correctly determining the district court erred in its obviousness analysis by misapplying the prior-art range precedent, the CAFC panel majority should have reversed or remanded for further fact-finding by the district court. Instead, Salix argues, the majority improperly made its own findings on key disputed factual issues never resolved by the district court, such as whether skilled artisans would have viewed small intestinal bacterial overgrowth (SIBO) as a cause of IBS-D or as a separate disorder. The majority relied on prior art references and made factual findings that the district court never made to conclude there was a reasonable expectation of success in using the claimed rifaximin dosage to treat IBS-D.

Additionally, Salix asserts the panel majority applied the wrong standard in determining that the district court’s erroneous reliance on a non-prior art reference (the “RFIB 2001 Press Release”) was harmless error. Rather than considering whether that reference induced the district court to make findings it otherwise would not have made, the majority simply concluded other evidence “established” the relevant fact. But as Judge Cunningham noted in dissent in the original panel decision, the district court heavily relied on the press release to discount evidence of skepticism in the art. The press release factored significantly into the court’s analysis.

Luv N’ Care – Scope of Unclean Hands Defense: The Federal Circuit affirmed the district court’s application of the unclean hands doctrine to bar Eazy-PZ’s patent and trade dress claims against Luv N’ Care due to Eazy-PZ’s litigation misconduct. Luv N’ Care, Ltd. v. Laurain, 2022-1905 (Fed. Cir. Apr. 12, 2024). In its petition for rehearing, Eazy-PZ argues that the panel majority departed from Supreme Court and Federal Circuit precedent requiring that unclean hands be based on misconduct having an “immediate and necessary relation to the equity that he seeks.” Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240 (1933); see also Gilead Scis., Inc. v. Merck & Co., 888 F.3d 1231 (Fed. Cir. 2018).

The district court concluded that the patentee Eazy-PZ had engaged in litigation misconduct—all of which was associated with the asserted utility patent. However, the resulting unclean hands penalty was to dismiss the entire case, including the design patent and trade dress claims. The petition argues this was an improper extension without analyzing how the alleged misconduct related to or provided Eazy-PZ an unfair advantage regarding those claims. The petition asserts that withholding information relevant to utility claim construction could not have advantaged the design and trade dress claims. Eazy-PZ argues this expansive application of unclean hands, untethered to the specific relief sought, vitiates the Supreme Court’s “immediate and necessary” relation requirement.

Regarding the ‘903 utility patent itself, Eazy-PZ argues the panel affirmed based on factual findings the district court never made about how any false or evasive testimony impacted Luv N’ Care, violating the rule that appellate courts cannot make factual findings in the first instance.

Decoding Patent Ownership beginning with Core Principles

by Dennis Crouch

In a recent decision, the Federal Circuit vacated a district court’s grant of summary judgment that an inventor, Dr. Mark Core, had automatically assigned a patent associated with his PhD thesis to his then-employer and education funder TRW.  Core Optical Techs., LLC v. Nokia Corp., Nos. 23-1001 (Fed. Cir. May 21, 2024). The key issue was whether Dr. Core developed the patented invention “entirely on [his] own time” under his employment agreement. The majority opinion written by Judge Taranto and joined by Judge Dyk held the contract language was ambiguous on this point and remanded for further factual development to determine the parties’ intent.  Judge Mayer dissented.

Although not discussed in the court’s decision, the appellant brief includes a suggestion that the Federal Circuit should “narrow or overrule” the automatic assignment law seen in FilmTec Corp. v. Allied Signal, Inc., 939 F.2d 1568 (Fed. Cir. 1991), and its progeny (more…)

Supreme Court Declines to Hear Vanda’s Patent Obviousness Appeal

by Dennis Crouch

The Supreme Court has denied Vanda Pharmaceuticals’ petition for certiorari, leaving in place a Federal Circuit decision that invalidated Vanda’s patents on methods of using the sleep disorder drug Hetlioz (tasimelteon) as obvious.

Vanda had argued in its cert petition that (more…)

The Use of Mandated Public Disclosures of Clinical Trials as Prior Art Against Study Sponsors

By Chris Holman

Salix Pharms., Ltd. v. Norwich Pharms. Inc., 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024)

Human clinical trials play an essential role in the discovery, development, and regulatory approval of innovative drugs, and federal law mandates the public disclosure of these trials. Pharmaceutical innovators are voicing concern that these disclosures are increasingly being used as prior art to invalidate patents arising out of, or otherwise relating to, these trials, in a manner that threatens to disincentivize investment in pharmaceutical innovation. A recent Federal Circuit decision, Salix Pharms., Ltd. v. Norwich Pharms. Inc., illustrates the concern.  In Salix, a divided panel upheld a district court decision to invalidate pharmaceutical method of treatment claims for obviousness based on a clinical study protocol published on the ClinicalTrials.gov. website. The case garnered amicus curiae briefs filed by several innovative pharmaceutical companies in support of the patent owner, Salix Pharmaceuticals. (more…)

De Forest Radio v. GE: A Landmark Supreme Court Decision on the Invention Requirement

By Dennis Crouch

In 1931, the United States Supreme Court decided a landmark case on the patentability of inventions, De Forest Radio Co. v. General Electric Co., 283 U.S. 664 (1931), amended, 284 U.S. 571 (1931). The case involved a patent infringement suit over an improved vacuum tube used in radio communications. While the case predated the codification of the nonobviousness requirement in 35 U.S.C. § 103 as part of the Patent Act of 1952, it nonetheless applied a similar requirement for “invention.”

I wanted to review the case because it is one relied upon in the recent Vanda v. Teva petition, with the patentee arguing that the court’s standard from 1931 has been relaxed by the Federal Circuit’s “reasonable expectation of success” standard. The decision also provides an interesting case study in the way that the court seems to blend considerations of obviousness and (more…)

Munsingwear Mootness in Sumitomo Pharma v. Vidal

by Dennis Crouch

Although non-precedential, the Federal Circuit’s new decision in Sumitomo Pharma v. Vidal offers the important conclusion that a patentee has no standing to appeal an invalidity holding once the patent expires, absent some showing of likely infringement during the prior six years.  Sumitomo Pharma Co. v. Vidal, No. 22-2276 (Fed. Cir. April 5, 2024).  The case is not so bad for the patentee because (more…)

Dow Chemical’s 1945 ‘Perfectly Plain’ Test for Obviousness

by Dennis Crouch

The pending obviousness petition in Vanda v. Teva has prompted me to look back on some of the key Supreme Court cases cited in the briefs. Last week, I wrote about Atlantic Works v. Brady, 107 U.S. 192 (1883) in a blog post titled The Quest for a Meaningful Threshold of InventionToday, I’m looking at Dow Chemical Co. v. Halliburton Oil Well Cementing Co., 324 U.S. 320 (1945), an obviousness case decided just a few years before a rewriting of the 1952 Patent Act.  At the time, the doctrine was identified as “want of invention,” but the court’s analysis is familiar to anyone practicing patent law today.


Obviousness and Pharmaceutical Method of Treatment Claims

by Dennis Crouch

In April 2024, the Federal Circuit issued a significant decision vacating a district court’s judgment that Janssen Pharmaceuticals’ dosing regimen patent claims were nonobvious. Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258 (Fed. Cir. Apr. 1, 2024). The case involved Janson’s U.S. Patent No. 9,439,906, which claims methods of treating schizophrenia by administering specific doses of the long-acting injectable antipsychotic paliperidone palmitate.

Teva filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Janssen’s Invega Sustenna product, which embodies the claimed methods. In the ensuing Hatch-Waxman litigation, Teva stipulated to infringement but challenged the patent on obviousness and indefiniteness grounds. Following a bench trial Judge Cecchi (D.N.J.) rejected Teva’s invalidity defenses, and Teva appealed.

On appeal, Judge Prost authored a unanimous opinion affirming the district court’s indefiniteness determination but vacating and remanding on obviousness.  Overall, this is a bad case for pharmaceutical formulary patents.

This post focuses on the court’s obviousness holding and its potential implications for pharmaceutical method of treatment claims more broadly. I make three key claims. . .


Today’s Obviousness Key: Motivation to Combine

by Dennis Crouch

The Federal Circuit’s recent decision in Virtek Vision International ULC v. Assembly Guidance Systems, Inc. focuses on the motivation to combine aspect of the obviousness analysis. The court’s ruling emphasizes that the mere existence of prior art elements is not sufficient to render a claimed invention obvious; rather, there must be a clear reason or rationale for a person of ordinary skill in the art to combine those elements in the claimed manner.  In the case, the IPR petitioner failed to articulate that reasoning and thus the PTAB’s obviousness finding was improper.


The Obviousness Hurdle

by Dennis Crouch

The U.S. Supreme Court is weighing whether to grant certiorari in Vanda Pharmaceuticals v. Teva Pharmaceuticals. I have been closely watching this obviousness case that could have significant implications beyond the pharmaceutical industry.  The following essay provides an overview of the key legal issues at stake and introduces Teva’s recent briefing.

The case centers on the proper legal standard for determining when an invention is “obvious” and therefore unpatentable under 35 U.S.C. § 103.  In particular, Vanda argues that the Federal Circuit has unduly raised the non-obviousness hurdle — barring patents based upon a “mere reasonable expectation of success” or that certain experiments would have been obvious to try, even though the result was not known.


More on Reasonable Expectation of Success from the Federal Circuit

by Dennis Crouch

In Sisvel v. TCT Mobile and Honeywell, the Federal Circuit has affirmed the PTAB’s IPR findings that the claims are obvious.  The non-precedential decision provides further insight into the Federal Circuit’s reasonable expectation of success test.

Sisvel’s U.S. Patent 8,971,279 covers a method of sending Semi-Persistent Scheduling (SPS) deactivation signals that essentially “piggyback” on existing messages. SPS is a technique used in LTE networks to more efficiently allocate radio resources to user equipment (UE) for periodic transmissions, such as Voice over IP (VoIP). In SPS, the base station pre-allocates resources to the UE for a set period of time, reducing the need for frequent scheduling requests and grants. SPS deactivation signals are messages sent by the base station to the UE to indicate that the pre-allocated resources are being released and are no longer available for the UE’s periodic transmissions. These signals are necessary to free up the resources when they are no longer needed, allowing them to be reassigned to other UEs or used for other purposes.

In the context of Sisvel’s ‘279 patent, the invention was directed to a specific method of sending SPS deactivation signals by filling a preexisting binary field (the resource indication value or “RIV”) with all “1”s. This 111111111 technique was intended to provide a more efficient way of signaling SPS deactivation while still ensuring that the deactivation message would not be mistaken for a valid resource allocation message.  In the patented system, the string of ones would always be processed as an invalid value and never mistaken for a valid resource allocation message, providing stability to the network, regardless of size.

TCT Mobile and others petitioned for IPR, asserting that the challenged claims were obvious based on various combinations of prior art, including Samsung and Dahlman. The PTAB found the claims unpatentable as obvious, and Sisvel appealed. (more…)

Pfizer v. Sanofi: Applying the Results-Effective Variable Doctrine in Obviousness Analysis

by Dennis Crouch

The Federal Circuit has affirmed the PTAB’s finding that Pfizer’s pneumococcal vaccine patent is obvious, but has vacated and remanded the Board’s denial of Pfizer’s motion to amend certain claims. Pfizer Inc. v. Sanofi Pasteur Inc., No. 19-1871 (Fed. Cir. Mar. 5, 2024); U.S. Patent No. 9,492,559. Pfizer v. Sanofi Opinion.


Obviousness: Is a Reasonable Expectation of Success Sufficient

by Dennis Crouch

In Vanda v. Teva, the Federal Circuit confirmed the obviousness of Vanda’s claims covering use of tasimelteon (Hetlioz) to treat circadian rhythm disorders (Non-24-Hour Sleep-Wake Disorder).  Teva and Apotex, filed Abbreviated New Drug Applications (ANDAs) with the FDA seeking to market generic versions of the $100m+ drug.  Vanda sued, but lost on obviousness grounds — with the court holding that the claimed combination was obvious because it was directed to a set of known elements and a person of ordinary skill would have a “reasonable expectation of success” in reaching the resulting invention.  The rulings here included a conclusion that – even if the particular limitations were not obvious, it would have been obvious for a skilled artisan to try them out.

Vanda argues that the law of obviousness requires more than simply a reasonable expectation of success. Rather, in their petition to the Supreme Court, the patentee argues that the resulting invention must have been “predictable” or an “plainly indicated by the prior art.”

The question presented is: Whether obviousness requires a showing of “predictable” results, as this Court held in KSR, or a mere “reasonable expectation of success,” as the Federal Circuit has held both before and after KSR?


A new amicus brief strongly supports the petition with an interesting historical review of obviousness doctrine from the past 150 years.  The brief, filed by The National Association of Patent Practitioners and Professor Christopher Turoski (current NAPP president) brief argues that the Federal Circuit’s “reasonable expectation of success” standard for assessing obviousness departs from longstanding Supreme Court precedent on obviousness that was subsequently codified in 35 U.S.C. § 103.  NAPP Amicus Brief.

Under Pre-1952 “Invention” Standard

The brief traces the obviousness requirement back to Hotchkiss v. Greenwood, 52 U.S. (11 How.) 248 (1850), where the Court held that simply substituting one known material for another in an otherwise unchanged device was obvious and lacked “that degree of skill and ingenuity which constitute essential elements of every invention.” In the 100 years of “invention” cases following Hotchkiss, the Court consistently held that an invention “must be the result of invention, and not the mere exercise of the skill of the calling or an advance plainly indicated by the prior art.” Altoona Publix Theatres, Inc. v. Am. Tri-Ergon Corp., 294 U.S. 477 (1935). The key question was whether the advance would “occur to any mechanic skilled in the art” or was “plainly foreshadowed by the prior art.” Loom Co. v. Higgins, 105 U.S. 580, 591 (1881); Textile Machine Works v. Louis Hirsch Textile Machines, Inc., 302 U.S. 490, 498 (1938).  None of the Supreme Court cases, either pre- or post-1952, rely upon reasonable expectation of success as a determinative factor in assessing the obviousness of an invention.

In Altoona Publix Theatres, the patentee sought to enforce its patent covering covering the use of a flywheel to sound recording and reproduction equipment in order to make the film movement more uniform. The Supreme Court held the patent claims invalid for lack of invention. The Court explained that a flywheel was a very old and common mechanism for improving uniformity of motion in machinery. Its addition here merely involved “the skill of the calling” rather than the inventive faculty, as the flywheel’s use was plainly indicated by prior art showing flywheels applied in other sound recording devices. The Court relied on longstanding precedent that an improvement is not patentable unless it required invention, not just ordinary skill, and was not “plainly indicated” in the prior art.

An improvement to an apparatus or method, to be patentable, must be the result of invention, and not the mere exercise of the skill of the calling or an advance plainly indicated by the prior art. . . . The inclusion of a flywheel in any form of mechanism to secure uniformity of its motion has so long been standard procedure in the field of mechanics and machine design that the use of it in the manner claimed by the present patent involved no more than the skill of the calling. . . . [The prior art] plainly  foreshadowed the use made of the flywheel in the present patent, if they did not anticipate it. The patentees brought together old elements, in a mechanism involving no new principle, to produce an old result, greater uniformity of motion. However skilfully this was done, and even though there was produced a machine of greater precision and a higher degree of motion-constancy, and hence one more useful in the art, it was still the product of skill, not of invention.

Altoona Publix Theatres, Inc. v. Am. Tri-Ergon Corp., 294 U.S. 477 (1935).  In Altoona, the court thus concluded that the added flywheel failed this “invention” test, so the patent claims were held invalid.  The standard in Altoona of “plainly indicated” in the prior art is foreshadowed in the Supreme Court’s prior cases such as Slawson v. Grand Street, P.P. & F.R. Co., 107 U.S. 649 (1883) (cannot patent “an idea which would naturally and spontaneously occur to any skilled mechanic or operator in the ordinary progress of manufactures”); see also Altantio Works v. Brady, 107 U.S. 192 (1883).

Similar “plainly indicated” language comes from the Supreme Court’s decision in Textile Machine Works v. Louis Hirsch Textile Machines, Inc., 302 U.S. 490 (1938). The invention at issue in the case was an attachment for flat knitting machines to allow reinforcing and split-seam designs to be added to the knitted fabric. The Court held the patent claims invalid as obvious and embodying no more than “the skill of the calling.”

The Court explained that “[t]he addition of a new and useful element to an old combination may be patentable; but the addition must be the result of invention rather than the mere exercise of the skill of the calling, and not one plainly indicated by the prior art.” Id.

One confusing element of this history is that the Supreme Court also began to talk of invention in terms of the “flash of creative genius” or other similar language. See Cuno Engineering Corp. v. Automatic Devices Corp., 314 U.S. 84 (1941). According to Cuno Engineering, to be patentable, a device “must reveal the flash of creative genius, not merely the skill of the calling.” Id.

Section 103 Codifies Prior Precedent

Prior to 1952, the patent act did not include a statutory obviousness standard. Rather, both the statute and the US constitution simply required an “invention.”

Congress created Section 103 obviousness standard in the 1952 Patent Act that we all rely upon today.  But, in its key and still leading analysis of the statute, the Supreme Court explained that the new law was “intended merely as a codification of judicial precedents embracing the Hotchkiss condition.” Graham v. John Deere Co., 383 U.S. 1, 17 (1966). Assessing obviousness under § 103 thus follows the Hotchkiss line of cases by determining whether the advance was “plainly evident from the prior art” such that one skilled in the art “would immediately see” that it was obvious based on the existing disclosures.

Of course, one change with the addition of Section 103 is the final sentence of the provision stating that the “manner in which the invention was made” will not negate patentability. The legislative history and Graham are both clear that this provision was intended “to abolish the test [Congress] believed [the Supreme Court] announced in the controversial phrase ‘flash of creative genius,’ used in Cuno.”  What is left then is a focus on whether the invention would be within the mere skill of the calling and plainly evident from the prior art. In its most recent analysis of KSR, the court did not use the plainly evident standard, but rather focused on situations where the elements of an invention were all known and the combination was nothing more than “predictable use of prior art elements.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Throughout this time the Supreme Court has never used a “reasonable expectation of success” test.

Departure from Binding Precedent

According to the petition and the amicus brief, the Federal Circuit’s “reasonable expectation of success” test sets a lower bar, finding obviousness wherever a skilled artisan might reasonably expect to achieve the result, even if it was not plainly foreshadowed in the prior art.  This includes situations where it might be obvious to pursue a research question — but where the answer to the question is unknown or unpredictable.

The first court reference that I have found for “reasonable expectation of success” standard appears to have originated in the case of Cmmw. Engr. Co. of Ohio v. Watson, 293 F.2d 157 (D.C. Cir. 1961).The Patent Office Board had originally stated that “Appellant has merely applied an old process to another analogous material with at least reasonable expectation of success. It is well settled that this does not constitute invention.”  The District Judge affirmed this holding in a Section 145 action, as did the D.C. Circuit Court on appeal. Cmmw. Engr. Co. of Ohio v. Watson, 188 F. Supp. 544 (D.D.C 1960), aff’d, 293 F.2d 157 (D.C. Cir. 1961).

I did also find a 1925 decision by the Commissioner of Patents office affirming a rejection. Ex parte McElroy, 337 Off. Gaz. Pat. Office 475 (1925).  In the case, the patent applicant argued that the cited reference was not sufficient to render the invention unpatentable — arguing “a reference must do more than suggest a possibility, that it must also postulate a reasonable expectation of success.”  The Assistant Commissioner rejected this argument, stating that Richter “carefully sets out the process of the present application and indicates its success.” The decision appears to agree with the  reasonable expectation of success standard, but concluded that the reference provided at least that level of teaching. But, it is not clear to me when this standard became sufficiently “settled” as recited in the 1960-61 Commonwealth Engineering decisions.  It was not until 1995 that reasonable-expectation-of-success was added to the MPEP, but by that time there had already been a number of Federal Circuit decisions on point.

In any event, I hope the Supreme Court will take up this case and push it forward — hopefully further developing obviousness doctrine.  Respondents in the case Teva and Apotex had waived their right to respond, but the Supreme Court expressed some interest in the case by requesting a response in a February 15 order (due March 18, 2024).


  • Vanda Pharmaceuticals Inc., Petitioner, represented by Paul Hughes (McDermott Will & Emery)
  • Apotex Inc. and Apotex Corp., Respondent, represented by Aaron Lukas (Cozen O’Connor)
  • Teva Pharmaceuticals USA, Inc., Respondent,  represented by J.C. Rozendaal (Sterne Kessler)

Amici Curiae

  • American Council of the Blind, Blinded Veterans Association, and PRISMS, Amicus Curiae, represented by Mark Davies (Orrick)
  • Professor Christopher M. Turoski and The National Association of Patent Practitioners, Amicus Curiae, represented by Ryan Morris (Workman Nydegger)
  • Salix Pharmaceuticals, Inc. and Ocular Therapeutix, Inc., Amicus Curiae, represented by Justin Hasford (Finnegan)


Livestream of LKQ v. GM

The Federal Circuit is hearing oral arguments today in the design patent case of  LKQ Corporation v. GM Global Technology Operations LLC 21-2348.  Judge Stoll’s opinion in the case sides with the patentee GM on the issue of obviousness — affirming a PTAB decision in favor of the patentee.  LKQ’s appellate team led by Prof. Mark Lemley argues that Federal Circuit’s obviousness standard (known here as the Rosen-Durling test) makes it too difficult to actual reject or cancel design patent claims.  Lemley argues for a much more flexible and common sense approach as required by KSR.  The USPTO’s amicus agrees Federal Circuit law should be expanded, but not as far as suggested by LKQ.  GM argues for the status quo.

According to the listing, the en banc panel today consist of Chief Judge Moore,  and Circuit Court Judges Lourie, Dyk, Prost, Reyna, Taranto, Chen, Hughes, Stoll, and Stark.  Not listed is Judges Cunningham and Newman.  

Livestream below: (more…)

Vanda Seeks Supreme Court Review on Lower Standard for Obviousness

Vanda Pharmaceuticals recently filed a petition for writ of certiorari, asking the Supreme Court to review a May 2023 decision by the Federal Circuit that invalidated claims from four Vanda patents covering methods of treating Non-24-Hour Sleep-Wake Disorder (“Non-24”) using the drug tasimelteon (Hetlioz). Vanda Pharmaceuticals Inc., v. Teva Pharmaceuticals USA, Inc., 23-768 (Supreme Court).  The district court held that all the asserted claims were invalid as obvious, and the Court of Appeals for the Federal Circuit affirmed this decision. Vanda.cert.petition


Federal Circuit Upholds PTAB’s Obviousness Finding and Joinder Decision in CyWee v. ZTE Smartphone Patent Case

The Federal Circuit recently affirmed a ruling by the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) filed by ZTE and joined by LG, finding claims of CyWee Group’s U.S. Patent No. 8,441,438 unpatentable as obvious. CyWee Group v. ZTE, No. 21-1855 (Fed. Cir. Jan. 18, 2024). The ’438 patent claims 3D motion-tracking technology for handheld devices like smartphones. The appeal included both IPR procedural issues and substantive patent law issues.  In siding with the PTAB, the Federal Circuit rejected CyWee’s argument that the Board should not have allowed LG to oppose CyWee’s motion to amend its claims. The court also affirmed the Board’s finding that the proposed amended claims would have been obvious over the prior art. (more…)

Fed Cir affirms PTAB decision Invalidating 1996 Patent on Mobile Base Stations

by Dennis Crouch

In a non-precedential decision, the Federal Circuit has affirmed a set of PTAB decisions canceling the claims of four patents owned by Carucel Investments L.P. (“Carucel”) — finding them invalid as obvious under 35 U.S.C. § 103. See Carucel Invs. L.P. v. Vidal, Nos. 2021-1731 (Fed. Cir. Dec. 26, 2023). The affected Carucel patents include U.S. Patent Nos. 7,221,904; 7,848,701; 7,979,023; and 8,718,543, with priority back to a 1996 application filing. All four patents relate to mobile communication systems involving base stations that can be mounted on moving vehicles. Carucel v. Vidal Opinion.

The original focus of the invention involved a closed-loop rail system running alongside a highway and that carried mobile base stations moving in the direction of the flow of traffic. That focus of the invention was quickly scrapped – likely as impractical.  But, the disclosure was seen as sufficient to also cover movable base stations with no rail limitation — allowing mobile base stations that might be on the cars and other vehicles themselves.

Multiple petitioners, including Mercedes-Benz, Volkswagen, and Unified Patents filed petitions seeking inter partes review (“IPR”).  Relying on KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007), the Patent Trial and Appeal Board (“PTAB”) instituted review and ultimately issued final written decisions concluding that the petitioners had proven by a preponderance of evidence that all challenged claims were unpatentable as obvious.

On appeal, Carucel disputed the PTAB’s claim constructions, obviousness determinations, and post-institution procedures under the Administrative Procedure Act (“APA”).  The Federal Circuit rejected Carucel’s arguments on all fronts.

Claim Construction: During inter partes review proceedings, the patentee is typically seeking a narrow construction of various terms in order to distinguish itself from the prior art. This has to be a careful argument — if the patentee goes too narrow then the accused infringers can also escape liability.

Here, the patent specification suggests that the mobile base stations are connected directly via cellular-network.  However, the claims themselves only use the terms “mobile device” and “mobile unit.” The court explained that neither the claim language nor the specifications justified restricting the scope to only cellular networks or requiring the mobile devices to directly register or communicate with the network.  In its analysis the court concluded first that the words “mobile device” refers to the capability of movement of a physical object and does not suggest the narrow construction requested.

On the obviousness determination, the Federal Circuit made the factual determination that a person of ordinary skill in the art would have been motivated to combine the teachings of the prior art with a reasonable expectation of success.  That determination quickly led to the legal conclusion that the claims were obvious.  On appeal, the Federal Circuit gives deference to PTAB fact finding under the substantial evidence standard. And here, the court found more than iota to support the conclusions — especially after deferring to the PTAB’s credibility findings favoring petitioner’s expert testimony.  At oral arguments, Brian Bear (Spencer Fane) argued that the Board had simply adopted the opposing expert testimony ipse dixit without providing critical analysis and, in particularly without explaining how the prior art combination overcame the “massive barrier” of incorporating the TDMA systems in some references alongside the CDMA systems in other references.   As with the PTAB decision, the Federal circuit decision does not provide a direct response or analysis regarding the TDMA/CDMA incompatibility issue.

Finally, the Federal circuit rejected Carucel’s argument that the PTAB’s denials of requests for Director Review violated the APA.  The denial orders themselves were unsigned, but still sufficiently identified the Commissioner Hirshfeld as the presiding officer.   In addition, the Director Review does not need to separately explain reasons for denial.  Although this is an agency action, the PTAB written decisions are “reviewable final decisions of the agency” despite intervening director denial.

Brian Bear of Spencer Fane argued the case for the patentee with Debra McComas of Haynes & Boone for appellees.  Michael Tyler from the PTO’s solicitor’s office also defended the opinions.  Judge Stark authored the unanimous opinion that was joined by Judges Dyk and Schall.

Supreme Court on Patent Law: November 2023

by Dennis Crouch

The Supreme Court is set to consider several significant patent law petitions addressing a range of issues from the application of obviousness standards, challenges to PTAB procedures, interpretation of joinder time limits IPR, to the proper scope patent eligibility doctrine. Here’s a brief overview of each case, followed by more details:

  1. MacNeil v. Yita (No. 23-494): This case examines the Federal Circuit’s reversal of a PTAB obviousness decision.  Petitioner argues that the appellate court substituted its own findings in the reversal rather than vacating and remanding.  This could be an important case for revitalizing the importance of secondary indicia of non-obviousness.
  2. Intel v. Vidal (No 23-135): This case challenges the “Fintiv rule” that restricts the initiation of inter partes review in cases where parallel district court litigation is pending.  The PTO is changing its approach, but Intel argues that the Agency isn’t going far enough.
  3. VirnetX v. Mangrove Partners Master Fund (No. 23-315): This case questions the Federal Circuit’s interpretation of time limits for joining IPR partes. Apple joined the petition long after it would have been barred from filing its own.  Although I sympathize with the petition, I believe the Federal Circuit got the statutory interpretation correct.
  4. Realtime Data v. Fortinet (No. 23-491): Here, Realtime Data challenges what it sees as lower court improper expansion of eligibility doctrine.  It asks the court to reiterate that eligibility is generally quite broad, subject to some quite narrow judge-made exceptions.
  5. Tehrani v. Hamilton Technologies (No. 23-575): This case involves a dispute over the PTAB’s obviousness finding and the Federal Circuit’s affirmation, particularly focusing on the qualifications of an expert witness, the proper interpretation of claim terms, etc.  There is some really interesting parts of the petition and case, but the petition largely re-argues the evidence — typically a losing approach at the Supreme Court.
  6. Vanda v. Teva (No. 23-___): I expect Vanda to challenge the Federal Circuit’s decision on the obviousness of its patents covering methods of using a particular drug. Vanda will argue that the court was too quick to jump to its obviousness conclusion.  If cert is granted, this would be a very important case.
  7. Traxcell Techs. v. AT&T (No. 23-574): This case examines whether attorney fees can be awarded based on pursuing litigation deemed “baseless” after a magistrate judge’s non-infringement recommendation but before the district judge finalizes that recommendation.

More detail on each case below: (more…)

A Point of View vs The Point of View: Federal Circuit’s Subtle Claim Construction

by Dennis Crouch

The Federal Circuit recently vacated and remanded a pair of Patent Trial and Appeal Board (PTAB) decisions that had upheld patent claims owned by Corephotonics. Apple Inc. v. Corephotonics, Ltd., No. 2022-1350 (Fed. Cir. Sept. 11, 2023). The appellate court held the PTAB erroneously construed a disputed claim term by failing to appreciate the significance of “a” versus “the” in the claims. It also found the PTAB violated the Administrative Procedure Act (APA) by resting its obviousness determination on arguments and evidence not squarely raised by the parties.

The Dispute Over Dual-Lens “Portrait Mode”

The patent at issue, U.S. Patent No. 10,225,479 (‘479 patent), relates to using dual-aperture camera systems in smartphones to create aesthetically pleasing “portrait photos.” Specifically, the patent discloses combining images from a wide-angle “Wide” lens and a telephoto “Tele” lens to produce a fused image showing a sharp subject in front of a blurred background.  Portrait mode is incredibly popular on Apple and Android phones and so the industry is eager to invalidate the patent held by Tel Aviv based Corephotonics.

Apple filed two petitions for inter partes review (IPR) challenging claims of the ‘479 patent as obvious based primarily on a prior art reference known as Parulski, which discloses a dual-lens digital camera but does not specify how image fusion occurs.  U.S. Patent No. 7,859,588.

Claim Construction – The Significance of “A” vs. “The”

In the first proceeding (IPR2020-00905), the parties disputed the proper construction of the claim term “fused image with a point of view (POV) of the Wide camera.” Apple argued this term required maintaining either the Wide image’s perspective or position point of view in the fused image, while Corephotonics contended it mandated both Wide perspective and position. Patentees often argue for narrow constructions during IPR proceedings in order to avoid the prior art. Here, the patentee’s narrow construction won the day and the PTAB found Apple failed to show the claims were obvious under this narrower construction.

Examining claim construction de novo, the Federal Circuit concluded that the PTAB had erroneously construed the term too narrowly based upon use of the indefinite article “a POV” as well as intrinsic evidence from the patent specification.

The court first looked at the claim language in context, noting the claims recite “a point of view” rather than “the point of view” of the Wide camera, suggesting the fused image need only maintain one type of Wide point of view. While the specification discloses that “point of view” includes both perspective and position, the claims’ use of “a” rather than “the” was critical:

A reasonable reading of [the specification] is that Wide perspective and Wide position are two different types of Wide point of view. The claim term requires only that the fused image maintain ‘a point of view of the Wide camera,’ i.e., only one of the disclosed types of Wide point of view.

Slip Op.  The court also explained that limiting the claims to require both Wide perspective and position would improperly exclude disclosed embodiments where the fused image has a “mixed” point of view, like Wide perspective but Tele position.

Taken together and in context, however, the intrinsic evidence supports that the claim term requiring a fused image maintaining ‘a point of view of the Wide camera’ requires only that the fused image maintain Wide perspective point of view or Wide position point of view, but does not require both.

With this broader construction, the Federal Circuit vacated the PTAB’s first decision and remanded for further analysis of whether the prior art disclosed the disputed limitation under the clarified standard.

While the Federal Circuit suggested the patentee could have defined “point of view” to require both perspective and position by using “the” in the claims, this may have been improper due to lack of antecedent basis. Generally, a new limitation should be introduced using an indefinite article like “a” rather than a definite article like “the.” The existence of this rule of patent claim drafting raises the question of how much interpretive weight should be given to a patentee appropriately following the rule. Here, the use of “a point of view” in the claims adhered to the common rule of using “a” to introduce a new limitation. The Federal Circuit relied heavily on this choice of article in reaching its broader construction. But because patentees are expected to follow this drafting rule, it is debatable whether such weight should be placed on the patentee’s decision to use “a” in accordance with standard practice rather than “the.” This highlights some tension between claim drafting best practices and reliance on subtle differences in claim language during claim construction.  Of course, the patentee could have simply drafted claims that clearly stated the structure being claimed.  Here, the Board noted that the disclosure was “not a model of clarity,” something that should weigh against the patentee.

Sua Sponte Findings Without Adequate Explanation or Opportunity to Respond

In the second proceeding (IPR2020-00906), Apple asserted specific claims reciting detailed camera parameters would be obvious based on combining Parulski with the Ogata reference. U.S. Patent No. 5,546,236. But the PTAB rested its determination that Apple had not proven obviousness almost entirely on typographical errors in the declaration of Apple’s expert, Dr. Sasián, which were barely mentioned by the parties.

Apple appealed both PTAB decisions to the Federal Circuit.

The appellate panel held that resting a determination of nonobviousness primarily on typographical errors in Apple’s expert declaration, without prior notice to the parties, violated the APA. The court explained that while the PTAB can reject unreliable expert testimony, it must provide a reasoned explanation supported by evidence and base its decision on issues the parties had notice and chance to address. Those factors were not present here:

Corephotonics did not rely on [the expert’s] error in any of its arguments on the merits. And it did not contend that this error demonstrated that there would have been no reasonable expectation of success or that it alone was a sufficient basis to find all of Dr. Sasián’s analysis unreliable.

Slip Op. Further, while the PTAB identified additional errors, these inconsistencies were never raised by the parties and appeared to lack evidentiary support.  The PTAB’s “explanations must be supported by substantial evidence, and its decisions must be reached only after the parties have been provided fair notice and an opportunity to be heard.”  Because the PTAB focused on peripheral issues not squarely presented by the parties, it failed to resolve the core obviousness disputes actually raised.

On remand, the PTAB will have the chance to try again — and, more particularly, Apple will get another bite at the Corephotonics patent.

Size Matters: Element-by-Element Analysis in Obviousness

by Dennis Crouch

In re Universal Electronics, Inc., No. 2022-1716 (Fed. Cir. Aug. 15, 2023) (non-precedential)

This was a consolidated appeal from two Patent Trial and Appeal Board (PTAB) decisions affirming the rejection of claims from Universal Electronics, Inc.’s (UEI) U.S. Patent Application Nos. 12/645,037 and 16/279,095 as obvious under 35 U.S.C. § 103.  On appeal, the Federal Circuit has affirmed.

The typical approach to obviousness determination is for the examiner to mentally divide the claimed invention into a number of individual elements, and then search for the individual elements within the prior art.  If the examiner finds all of the limitations, then the only key question that remains is whether the combination would have been obvious. Under KSR, that outcome does not necessarily require further evidence, but typically focuses on questions of whether PHOSITA would have been motivated to combine the references to create the invention, and have a reasonable expectation of success of that endeavor.  On the other hand, based upon my experience, examiners are much more uncomfortable finding claims obvious where particular elements are not found in the prior art. This difference is reflected in KSR and other older cases where the Supreme Court has been most critical of patents merely claiming a combination of known elements.

As a prosecution strategy, patentees have some control over the “size” of each element through their organization of claim language.  Here though, the patentee attempted to do this via argument, but ultimately failed. Lets look at the rejection and the arguments here:

The claims at issue relate to a system and method for providing improved user input functionality on a controlling device, such as a universal remote control. Representative claim 1 of the ‘037 application recites determining and then using a particular “touch location” on a touch sensitive surface to retrieve command data from a library stored in the controlling device’s memory. The Examiner rejected the claims as obvious over two prior published patent applications, Fisher and Dresti. Fisher discloses determining a touch location and using it to control an appliance. Dresti discloses retrieving command data from a library in the remote control’s memory.

The patentee argued that a key component of the invention was not found in the prior art. In particular, UEI argued that neither reference individually taught the limitation of a “controlling device that uses a determined touch location to retrieve command data from a library of command data stored in a memory of the controlling device.”  Admittedly, each individual bit of this limitation was found in one of the prior art references, but the patentee argued that this feature should be treated as an entire limitation.

On appeal, the Federal Circuit found the argument unpersuasive, concluding that the rejection properly relied upon a combination of prior art to teach all of the claim limitations.  As the patentee here attempted, attorneys can argue against dividing the claims into smaller pieces. However, it is an uphill battle once the examiner and PTAB have defined the elements narrowly and found them in separate references.

The takeaway may be that attorneys should advocate for the broader, unified view of the invention during early prosecution to avoid being boxed into a narrow element-by-element approach. Carefully crafted claims and thorough responses emphasizing the integrated advance can help shape the analysis in the desired direction. But as this case shows, it can be difficult to overcome once piecemeal elements are embedded in the record.

Unfortunately, the non-precedential opinion does not provide any detail analysis for when a tribunal be satisfied with micro vs macro elements. But, I can imagine that we’ll look to the claim language, specification disclosure, and PHOSITA knowledge.

This is the same issue that arises during infringement analysis with application of the doctrine of equivalents.

Thus, the PTAB’s conclusions that the claims would have been obvious over the cited references.

Judges: Circuit Judges Reyna, Taranto, and Stoll