Tag Archives: obviousness

In my view, Obviousness is the most fundamental of patent law doctrines, and certainly much of the work of patent attorneys is to convince patent examiners that the claims are not obvious.

Making a Proper Determination of Obviousness

Patent,

by Dennis Crouch

Earlier this week, the USPTO published updated examination guidelines regarding obviousness determinations under 35 U.S.C. §103. While these new guidelines are not legally binding, they offer important insight into how the Office plans to apply an even more flexible approach to obviousness — something Director Vidal sees as mandated by the Supreme Court’s 2007 decision in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). (2500 words).

Read the Guidance Here.

Overall the guidance here suggests that the office is looking to make non-obviousness a larger hurdle via increased flexibility.  Still, the guidelines spend some time on the requirements of a prima facie case; the necessity of both evidence and reasoning to support any obviousness rejection; and consideration of all evidence before the examiner.  Obviousness is already the most common rejection – with the vast majority of applications being initially rejected as obvious.  It will be interesting to see whether the rates go up even further following this new guidance. 

This post breaks down the guidelines and walks through some potential strategies for patent applicants. 

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Obviousness: Is a Reasonable Expectation of Success Sufficient

Patent,

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?

VandaCertPetition.

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).

Parties:

  • 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)

 

The US Constitution as an Interpretive Tool for Obviousness Law

Patent

by Dennis Crouch

LKQ’s brief for today’s en banc rehearing begins with the following interesting statement: “As with utility patents, the U.S. Constitution and the Patent Act prohibit design patents on ordinary innovations.” It is the Constitutional question that is most interesting and calls forth the concurring opinion by Justice Douglass in the Great A&P Case.

The attempts through the years to get a broader, looser conception of patents than the Constitution contemplates have been persistent. The Patent Office, like most administrative agencies, has looked with favor on the opportunity which the exercise of discretion affords to expand its own jurisdiction. And so it has placed a host of gadgets under the armour of patents—gadgets that obviously have had no place in the constitutional scheme of advancing scientific knowledge. . . . The fact that a patent as flimsy and as spurious as this one has to be brought all the way to this Court to be declared invalid dramatically illustrates how far our patent system frequently departs from the constitutional standards which are supposed to govern.

Great A&P Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 156 (1950). Although case applied pre-1952 law, the reminder here is poignant. Justice Douglas goes on:

It is worth emphasis that every patent case involving validity presents a question which requires reference to a standard written into the Constitution. . . .  The Congress does not have free reign, for example, to decide that patents should be easily or freely given. . . . Every patent is the grant of a privilege of exacting tolls from the public. The Framers plainly did not want those monopolies freely granted. The invention, to justify a patent, had to serve the ends of science—to push back the frontiers of chemistry, physics, and the like; to make a distinctive contribution to scientific knowledge. That is why through the years the opinions of the Court commonly have taken ‘inventive genius’ as the test. It is not enough that an article is new and useful. The Constitution never sanctioned the patenting of gadgets. Patents serve a higher end—the advancement of science.

The standard of patentability is a constitutional standard; and the question of validity of a patent is a question of law.

Id.   Later, in Deere, the Supreme Court suggests found that the newly written Section 103 was properly seen as statutory codification of the court’s standard “which exists in the law and has existed for more than 100 years, but only by reason of decisions of the courts.”  And, that standard is derived from the Court’s understanding of the U.S. Constitution’s requirement that the patent laws be designed to “promote the Progress of Science and useful Arts.”

The Congress in the exercise of the patent power may not overreach the restraints imposed by the stated constitutional purpose. Nor may it enlarge the patent monopoly without regard to the innovation, advancement or social benefit gained thereby. Moreover, Congress may not authorize the issuance of patents whose effects are to remove existent knowledge from the public domain, or to restrict free access to materials already available. Innovation, advancement, and things which add to the sum of useful knowledge are inherent requisites in a patent system which by constitutional command must ‘promote the Progress of * * * useful Arts.’ This is the standard expressed in the Constitution and it may not be ignored. And it is in this light that patent validity requires reference to a standard written into the Constitution.

Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 5–6 (1966).

Bringing this back to design patents and the LKQ case, the patent challenger here does not deeply engage with the constitutional question, but rather appears to use it as a constant interpretative reminder. GM’s brief does not mention the Constitution or its requirement to “promote the Progress.”  Likewise, none of the Federal Circuit’s obviousness decisions from the past year discussed the doctrine in light of the Constitutional requirement.

 

Vanda Seeks Supreme Court Review on Lower Standard for Obviousness

Patent,

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

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

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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…)

Patent Law Exam 2023: Are you Smarter than a Law Student?

Patent

by Dennis Crouch

The following is my patent law exam from this past semester. As in years past, the exam was worth less than half of the final grade because the students did other substantial work during the semester, including a major moot court competition.   Students were permitted access to their book/notes/internet, but were barred communications with another human during the exam.

This year’s exam is very loosely based upon an interesting patent that I found associated with the Tow Whee product created by Eric Landis.  See US11167164, US11731470, and US11724148.  But, the events described are entirely my creation.

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Federal Circuit Continues to Apply Strict Obviousness-Type Double Patenting Analysis

Patent

by Dennis Crouch

This post gets into some weeds about obviousness type double patenting stemming from the Federal Circuit’s new decision in Institut Pasteur.  Although non-precedential, the decision signals that the doctrine remains strong (and strict). The decision cements that for OTDP analysis, any comparison of unexpected results or long-felt need must be made to the applicant’s own earlier patent claims, not the closest “prior art.”  The court also endorsed reliance on inherency to satisfy claim limitations not found in earlier claims.

I’ll note here en banc petition briefing continues in the OTDP/PTA case of In re: Cellect, LLC.  Cellect’s petition has been supported by 10 amicus briefs. The PTO responsive brief is due December 14, 2023.

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The Federal Circuit recently affirmed a PTAB rejecting claims in a patent application filed by Institut Pasteur on the ground of obviousness-type double patenting. In re: Institut Pasteur, No. 2022-1896 (Fed. Cir. Dec. 13, 2023) (non-precedential). This case provides additional insight into the doctrine of obviousness-type double patenting and the ongoing high bar set by the Federal Circuit for overcoming such rejections.  Opinion by Judge Clevenger, joined by Judges Taranto and Stoll.

Obviousness-type double patenting is a judge-made doctrine designed to prevent applicants from extending patent rights first obtaining an earlier-expiring patent and then obtaining a later-expiring patent with claims that are obvious variants of those in the earlier patent. The policy goal is to prevent unjustified timewise extension of exclusive patent rights.  The doctrine was particularly relevant for patent applications filed prior to 1995 because patent term was calculated at 17 years after patent issuance. Today, patent term starts ticking as soon as the patent application — making it much more difficult to stagger patent rights in order to evergreen protection. (Note that one way to differentiate patent timing is through PTA — and that is being challenged in the Cellect case discussed above.) In addition, the doctrine is designed to protect potential defendants from unfairly facing multiple infringement lawsuits.

The Gap in 102 for Self-Harming Prior Art: Everyone knows that you cannot obtain a patent that merely claims an obvious variant of the prior art. 35 U.S.C. 103. Section 102 of the Patent Act defines prior art, and includes an important exception that is incredibly relevant to the OTDP situation. In particular, we know that the first-inventor-to-file provision found in 102(a)(2) spells out, as the name suggests, that a prior-filed patent application (once it becomes public) will serve as prior art against a later filed patent application. The important exception for OTDP purposes is that Congress limited the first-to-file provision of 102(a)(2) to applies only in cases where the two competing patent applications name different inventors and are owned by different entities. In other words, Congress carved out an exception such that your own earlier-filed patent application does not qualify as prior art that could invalidate your later-filed application under 102(a)(2), even after the earlier application publishes.  Although this analysis uses post-AIA statute, the limited protection for applicants against self-harming prior art also existed in the pre-AIA statute.

What we have here is a gap in the scope of prior art within the statute associated with the patentee’s own pre-filing activities. Courts have acknowledged that these filings by patent applicants are not prior art under the statute, but recognize policy concerns that justify limiting applicants’ rights anyway. Specifically, courts want to prevent applicants from unjustly extending patent protection with repetitive filings on obvious variants of their own inventions. Additionally, courts are concerned that separated patents (especially if ownership is separated) could put defendants at risk of facing multiple lawsuits asserting what is essentially the same invention.

The judge made solution then is to act in equity to bar an applicant from obtaining or enforcing to patents that are obvious variants to one another unless the patent applicant has filed what is known as a terminal disclaimer that disclaims any potential extra patent term in the later-issuing patent and that also promises to keep the two patents under the same ownership.  Applicants who fail to file such a disclaimer can find their applications refused by the PTO or found unenforceable by the courts.

Ordinarily, obviousness analysis compares a claim against prior disclosures.  OTDP is different.  In OTDP, the policy concern is focused on obtaining two patents whose claims are too close to one another.  Thus, the OTDP analysis compares the two sets of claims and asks whether one set is an obvious variant of the other.

In Institut Pasteur, the patent applicant filed a patent application in 2015 directed to methods of treating pain by administering opiorphin. The examiner rejected the pending claims as obvious over the claims of a different Pasteur patent directed to similar methods of pain treatment using the same peptides, and that had been filed the year before, in 2014.

Before the Board, Pasteur argued that OTDP should not apply — arguing that its 2015 applicant claimed claimed methods that were significantly different from those in the 2014 patent. In particular, the 2015 applicant required administration of the peptides for seven days without inducing drug dependence or tolerance, whereas the 2014 patent did not specify any particular duration of treatment or recite the lack of dependence/tolerance.  The PTAB rejected that distinction and instead affirmed the examiner’s rejection, finding that the 2014 patent embraced treatment of chronic pain, so it would have been obvious to administer the therapy for over seven days. The Board also found that avoiding dependence/tolerance would be an inherent result of carrying out the methods of Pasteur’s earlier 2014 patent.

On appeal, the Federal Circuit affirmed the Board’s decision strictly applying obviousness-type double patenting. The court reiterated that when unexpected results are used to rebut a prima facie case of obviousness, those results must be shown to be unexpected compared to the closest prior art (here, Pasteur’s 2014 patent).  In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Pasteur failed to make that comparison. The court also endorsed the Board’s use of inherency to fill in the missing claim limitation of dependence/tolerance as part of the obviousness analysis.  The trick here that the court played, is that this “closest prior art” precedent comes from ordinary obviousness cases, not OTDP cases.  See Baxter.   And, as you recall, Pasteur’s 2014 patent is not prior art. Here, the court made the leap that it should effectively be treated as prior art for all aspects of the OTDP obviousness analysis, including both evidence of unexpected results and secondary considerations of nonobviousness.

Regarding secondary considerations, the Federal Circuit affirmed the Board’s dismissal of Pasteur’s long-felt need evidence. Pasteur had argued there was a long-felt need for pain medication that avoids issues of drug tolerance and dependence. However, the court endorsed the Board’s finding that any such need was already satisfied by Pasteur’s 2014 patent claims. In other words, in obviousness-type double patenting, where reference claims satisfy a long-felt need, that need does not constitute objective evidence for a later patent’s claims of non-obviousness over the reference claims.

During oral arguments, Salvatore Arrigo argued on behalf of Institut Pasteur before the panel of Judges Taranto, Clevenger, and Stoll.  Arrigo emphasized that unexpected results are an “integral part” of determining obviousness under Graham v. John Deere. He argued that the unexpected lack of tolerance and dependence when administering the claimed peptide for 7 days should be considered in the prima facie obviousness analysis, before reaching a conclusion on obviousness:

You have to look at the unexpected results first to figure out if it’s obvious. If you don’t, it’s always an expected results are always going to be inherent 100 percent of the time because you’ve already reached obviousness before considering. It’s part of the obvious analysis to get there.

The judges questioned whether the proper comparison should be to morphine or to the closest prior art, the claims of the ‘871 patent. Mr. Arrigo maintained morphine was the appropriate comparison “because the prior art is just this giant genus and no one within that genus ever did anything that would have shown this unexpected result.”  In its decision, however, the Federal Circuit rejected this analysis — holding that for OTDP analysis, any unexpected results must be in comparison to the company’s other patent being analyzed.

Brushed Aside? Dafni Tries to Keep its PTAB Win against Ontel

Patent

by Dennis Crouch

Ontel Products Corp. v. Guy A. Shaked Investments Ltd., No. 22-1938 (Fed. Cir.)

This pending case raises key issues of (1) mootness in the IPR/Court interplay and (2) the role of secondary indicia in obviousness determinations.

Gary Shaked (Dafni) holds several patents on hair straightening brushes, and the business took off as a video of the time-saving tool went viral. Dafni sued Ontel and others for patent infringement based upon several utility and design patents.  Dafni responded with an IPR of one of the patents. U.S. Patent No. 9,877,562.  Although the IPR was instituted, the patentee eventually won a judgment confirming that the claims were not proven invalid.  The PTAB’s non-obviousness decision was largely based upon a indirect indicia of non-obviousness, including evidence of industry praise and industry adoption.

Meanwhile, back in the district court, the patentee wanted to move forward with the litigation and offered to dismiss the ‘562 patent from the litigation (with prejudice) in order to lift the stay.  The defendant agreed and the parties jointly filed a stipulated dismissal of that claim.

Of course, the IPR was not automatically dismissed just because the litigation over the patent was dismissed. When the patentee eventually won the IPR, petitioner appealed.

In the appeal, there are two main questions:

  1. Whether the appeal should be dismissed as moot and the IPR vacated under Munsingwear because of a lack of ongoing actual controversy between the parties regarding the patent.
  2. On the merits, were the indirect indicia of non-obviousness properly considered.

The petitioner here is not going to be sued on the patent for any of its current activities. But, petitioner still argued that the PTAB decision could be used by the district court to help prove the secondary considerations of non-obviousness with regard to the other asserted patents.

On the standing/mootness questions, the court really has three options:

  1. Find that it has proper standing and that the case is not moot — then move forward with the appeal.
  2. Find that the case is moot and vacate the PTAB decisions upholding the patent under cases such as United States v. Munsingwear, Inc., 340 U.S. 36, 39–41 (1950).
  3. Find that the case is moot and/or lacks standing, but refuse to vacate the PTAB decision based upon the “voluntary cessation doctrine” discussed in ABS Global, Inc. v. Cytonome/ST, LLC, 984 F.3d 1017 (Fed. Cir. 2021).

The voluntary cessation doctrine – indicates that a party who wins a judgment below  but who might lose on appeal cannot keep that judgment in place by taking affirmative steps to moot the appeal.  Rather, in Munsingwear, the Supreme Court indicated that the appropriate appellate action in that situation where appellant is constitutionally prohibited from appealing under Article III is to also vacate the lower court judgment.  During oral arguments before Judges Taranto, Chen and Cunningham, the parties debated whether the patentee had unilaterally created the mootness by dismissing its infringement assertion.  The petitioner (accused infringer) argued it was effectively unilateral, and that the joint-stipulation of dismissal was a mere formality.  The patentee argued that the accused infringer had a hand in the dismissal and so cannot now use that act to collaterally attack a PTAB decision that it does not like.  I believe that the patentee here has the better argument, the defendant was clearly a participant in the dismissal of the claims as part of a negotiated process and so it cannot be seen as unilateral.  We’ll have to wait to see what the Federal Circuit says.

In general though, I hope that the court reaches the merits because I am working a paper involving objective indicia of non-obviousness and would like another decision to study.

A key issue on appeal is whether the patent owner properly established a nexus between the evidence of industry praise and industry acceptance for its DAFNI hair straightening brush and the claimed features of the ‘562 patent.

As the Federal Circuit has made clear, “Evidence of objective indicia of nonobviousness must have a nexus to the claims, i.e., there must be a legally and factually sufficient connection between the evidence and the patented invention.” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373–74 (Fed. Cir. 2019).  Lack of proven nexus has been repeatedly used to deny the relevance of key objective evidence that would otherwise tend to show nonobviousness.

Ontel argues that Dafni failed to meet the Fox Factory test. Specifically, Ontel contends that:

  • None of the industry praise evidence shows that the praise directly resulted from the unique characteristics of the invention as identified by the Board, such as the elongate heating elements, insulating spacers, and peripheral spacers.
  • Much of the evidence relates to unclaimed features or features found in other Dafni patents, which rebuts a finding of nexus.

In addition to lack of nexus, a patentee’s arguments for secondary considerations are often denied if the evidence provided is not significant enough or compelling. This has two levels of impact. First, a tribunal may make a factual finding that the evidence is insufficient to establish, for instance, industry praise or industry acceptance.  Second, the tribunal may also use the low level of evidence when answering the ultimate legal question of obviousness — finding that the secondary considerations are insufficient to outweigh the direct evidence presented.

Here, the patent challenger argued that Dafni’s evidence of industry praise and acceptance was not significant or compelling enough to support the Board’s finding. Specifically, Ontel contended that the evidence relied upon by Dafni and the Board was “neither significant nor compelling” because (1) it consisted merely of a handful of internet articles by individual users rather than industry praise; (2) Dafni made no showing that any of the articles constituted industry praise; and (3) much of the evidence suffered from numerous weaknesses like being promotional in nature or failing to technically analyze the product.  Thus, Ontel argued the evidence was inadequate to establish the “significant industry praise and acceptance” found by the Board both as a factual matter and when weighing it against the strong showing of prima facie obviousness in the ultimate legal obviousness analysis.

In response, Dafni argues that substantial evidence supported the Board’s finding that a nexus existed to the claimed invention based on:
  • Crediting of Dafni’s expert testimony linking the claimed features to the capabilities for which the DAFNI brush was praised, such as the ability to quickly and effectively straighten hair.
  • Establishing that a nexus can rely on a unique combination of known individual elements.
  • Ontel failing to rebut Dafni’s prima facie showing of nexus with evidence that the praise related to unclaimed or prior art features.

Oral arguments got stuck on the standing/mootness issues and so the parties did not further advance their arguments on the merits of the obviousness case. The Federal Circuit will thus have to weigh the arguments as briefed if it permits the case to move forward.

Supreme Court on Patent Law: November 2023

Patent,

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…)

The Complex Fact/Law Divide in Obviousness Analysis

Patent,

by Dennis Crouch

The intersection between factual inquiries and legal conclusions in patent law is a complex and ever-evolving area, this is especially true in obviousness doctrine. A recent Federal Circuit decision highlights the tricky analysis required in assessing obviousness and damages in patent cases. In Cyntec Co. v. Chilisin Electronics Corp., the appellate court examined whether the lower court’s directed verdict (JMOL) of nonobviousness improperly removed factual questions from the jury.  This case provides an important reminder of the care required in delineating the fact finding and legal determinations in patent trials.  As is common, I think both the District Court and the Federal Circuit got it wrong.

Note, the court’s decision includes an interesting analysis of damages, finding that the plaintiff’s damages expert should have been excluded. It also includes a useful claim construction decision on when to give a term its plain and ordinary meaning.

A molded choke is a device used in electronic devices to filter undesirable signals.  The device contains a coiled conducting wire encapsulated in a molded mixture of magnetic powder. The powder is heated to a sufficiently high temperature to allow it all to bond together.  The patentee, Cyntec, had experienced some difficulties in creating the devices — with the high heat causing various problems such as melting the conducting wire or its insulative layer.  The solution that they hit upon was using a mixture of magnetic powders with different hardness and particle sizes.  This permitted a lowering of the required molding temperature and thus avoided wire damage during molding.  See U.S. Patent Nos. 8,922,312 and 9,481,037.

Competitor Chilisin began selling its own molded chokes and Cyntec sued for infringement.  At trial, Chilisin presented invalidity arguments that the claims were obvious based on two prior art references – Shafer and Nakamura. However, the district court granted JMOL of nonobviousness in favor of Cyntec before the case went to the jury (i.e., directed verdict). The jury subsequently found infringement and awarded full lost profits damages based on Cyntec’s expert calculations.

Although obviousness is ultimately a question of law, it depends upon upon substantial factual finding.  The particular threshold of where factual findings end and legal conclusions begin is quite tricky in this area.  In KSR, the Supreme Court appeared quick to determine as a matter of law that it PHOSITA would have been motivated to combine the references in a way rendering the claims obvious.  In subsequent cases, however, the Federal Circuit took pains to tease out motivation to combine from the ultimate conclusion of obviousness.

“Before KSR, we had also consistently treated the question of motivation to combine prior art references as a question of fact… KSR did not change this rule ….” Wyers v. Master Lock Co., 616 F.3d 1231, 1238–39 (Fed. Cir. 2010) (as quoted in Apple Inc. v. Samsung Elecs. Co., Ltd., 839 F.3d 1034, 1051 (Fed. Cir. 2016) (en banc)).

But, the fact/law divide is a bit more complicated in Cyntec because it involves a Judgment as a Matter of Law (JMOL).  We typically have two distinct types of legal questions at the JMOL stage:

  1. Regular questions of law, such as the meaning of a statute or the ultimate conclusion of a patent claim’s obviousness; and
  2. Lopsided questions of fact, where the evidence so favors one-side that no reasonable jury could find otherwise.

At JMOL, the district court is empowered to make these two types of legal conclusions, but cannot otherwise invade the jury’s factfinding role.

Adding to the difficulty is the reality that determination of the Graham factors rarely lead directly to the obviousness/nonobvious determination.  In Graham, the Supreme Court indicated that courts should work through the following for step fact-finding process and then rely upon the results to make the ultimate legal conclusion of obviousness.

These factual questions include: “(1) the scope and content of the prior art, (2) differences between the prior art and the claims at issue, (3) the level of ordinary skill in the pertinent art, and (4) [if presented,] the presence of objective indicia of nonobviousness such as commercial success, long felt but unsolved needs, failure of others, and unexpected results.”

Cyntec Co. v. Chilisin Electronics Corp., No. 22-1873 (Fed. Cir. Oct. 16, 2023) (quoting Elbit Sys. of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1357 (Fed. Cir. 2018)).   The point here is that even after the fact-finder has made all the factual findings, there is still quite a bit of work for a the law-decider to do.  That said, quite a bit of the work is occupied by the motivation-to-combine factual finding.

Here, the patentee presented prior art and testimony regarding a motivation to combine. The district court found the evidence insufficient and awarded JMOL for the patentee.  On appeal, the Federal Circuit vacated that decision and instead concluded that “Chilisin presented the jury with evidence that would have allowed it to reasonably find the asserted claims obvious in view of Shafer and Nakamura. . . . Taken together and drawing all reasonable inferences in Chilisin’s favor, this evidence is enough for a reasonable jury to have found that the asserted claims would have been obvious.”

I have an important nitpick with the appellate court’s decision that goes back to the complexity of the law-fact divide in obviousness analysis.  The court skipped an important step by simply concluding that a reasonable jury could have found the claims obvious. Recall that obviousness is a question of law, and at JMOL we are only concerned taking disputed facts away from the jury.  The appellate court should have instead explained something like the following: “that the defendant presented evidence sufficient to put the factual question of motivation-to-combine into dispute in a way that, if taken as true, would lead to a legal conclusion of obviousness.”

The distinction here is important, the Federal Circuit’s rule here makes it harder to award summary judgment of non-infringement because it places an additional layer of reasonableness on the ultimate legal conclusion of obviousness. But that is a question of law, and with questions of law we don’t account for reasonable fact finders but instead ask only whether the question was decided rightly or wrongly. This distinction is why legal determinations are reviewed de novo on appeal and factual findings are given deference. This analysis also reveals the dirty secret that, although the law does not permit reasonable deference into legal questions, reasonable minds regularly do disagree upon the conclusion of obviousness even after making all the underlying factual findings.

On remand, the district court must ensure that the jury is tasked only with resolving the factual disputes, while reserving the ultimate legal question for itself. Carefully delineating the fact finding and legal conclusions will be critical to applying the proper review on any subsequent appeal.

= = =

Regarding damages, the Federal Circuit found the district court abused its discretion in admitting Cyntec’s expert testimony on alleged lost profits. Cyntec’s expert used total revenue from customer SEC filings to estimate what percentage of products containing the accused chokes were imported into the U.S. However, the appellate court found his methodology “speculative” because the filings included revenue from products that did not contain accused chokes, without distinguishing between them. Citing precedent like Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 711 F.3d 1348 (Fed. Cir. 2013), the Federal Circuit held the expert “assumed that (1) the sales revenue reported in the customers’ Form 10-K reflected sales of products with molded chokes; and (2) each third-party product shipped into the United States contained an infringing choke.” This “speculative” testimony should have been excluded under Daubert. The appellate panel thus vacated the lost profits award.  On remand, the damages calculation will need to be reevaluated without the flawed expert testimony, likely with a new trial focusing on obviousness and damages.

 

Secondary Considerations Get Short Shrift in Airbed Patent Fight

Patent

by Dennis Crouch

Team Worldwide Corp v. Intex Recreation Corp. (Fed. Cir 2023)

I was disappointed to see the Federal Circuit’s no-opinion affirmance in this case — affirming the PTAB finding that Team Worldwide’s inflatable airbed invention was unpatentable as obvious.  US9211018. The case peaked my interest because I have been working on a short article focusing on what the courts term “secondary considerations” of obviousness, and the patentee raised substantial evidence of commercial success.   Ultimately the PTAB sided with the patent challenger and and that determination was affirmed on appeal in a R.36 no-opinion judgment.

TWC’s patent claims an “inflatable product,” such as an air mattress, that has a built-in electric pump.  In particular, the electric pump is built into and recessed within the exterior wall of the mattress with just one side of the pump body exposed through the exterior wall. The rest of the pump body is hidden inside the inflatable body and permanently held in place within the exterior wall of the inflatable body. The recessed design keeps the pump partially hidden and out of the way when not in use.

The key prior art references in the case are

  • U.S. Patent No. 6,018,960 (1996) (“Parienti”), which discloses an air mattress having an externally-attached solar powered pump.
  • U.S. Patent No. 2,493,067 (1945) (“Goldsmith”), which discloses ordinary inner-spring mattress having an attached fan used for temperature control (not inflation).  One embodiment includes “housing arranged within … said mattress and carrying a blower and temperature changing means therein.

This product has been a huge seller via brands such as Intex, Bestway, Boyd, Airtek, Air Cloud, Air Comfort, AirBedz, Altimair, Pittman, and TexSport.  The patentee has sued a number of folks for infringement, and they fought back with this Inter partes review proceeding.

The PTAB initially sided with the patentee, concluding that the claims had not been proven obvious. However, on appeal, the Federal Circuit vacated and remanded.

The Board misapplied the obviousness standard, and misapprehended Intex’s argument, when it fixated on whether the prior art literally disclosed Intex’s theory of modifying Parienti only slightly by taking the pump attached to the outside of the mattress and recessing it partially within the mattress. Intex’s argument regarding its proposed modification showed that Parienti was already close to the challenged claims, and only a slight change was needed to satisfy the broadest reasonable interpretation of “wholly or partially” recessing a pump. This showing, together with Intex’s showing that numerous references since the late 1800s illustrated prior artisans’ intuitive desire to recess pumps to save space, satisfied Intex’s burden [under KSR]. The Board erred in concluding to the contrary.

Intex (Fed. Cir. 2021).  Thus, in its 2021 decision the Federal Circuit concluded that Intex had satisfied its burden of proving the invention obvious. The only problem though was that the PTAB/CAFed had not yet considered secondary indicia of non-obviousness offered by the patentee.  Thus, remand was needed for the PTAB to address issues it previously declined to reach. Specifically, the PTAB had not addressed Team Worldwide’s evidence on objective indicia of non-obviousness.

On remand, the PTAB flipped its decision, finding the claims obvious despite substantial sales and other secondary considerations.  In its most recent appeal, Team Worldwide argued that the PTAB erred in its assessment of the objective evidence of nonobviousness. Specifically, Team Worldwide argued that the PTAB did not properly weigh the evidence presented regarding commercial success, failure of others, and industry praise.

Regarding commercial success, the PTAB found that Team Worldwide was entitled to only “some, but not considerable, weight in favor of non-obviousness” for the evidence of sales of infringing products, citing the impact of non-patented features on customer demand.  However, Team Worldwide argued that the PTAB ignored evidence that the majority of sales were of products admitted or shown to infringe, which constitutes overwhelming commercial success under Federal Circuit precedent. See Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1376 (Fed. Cir. 2011).

For failure of others, the PTAB concluded that Team Worldwide’s evidence was entitled to only “some weight.” But Team Worldwide argued that the PTAB improperly minimized competitors’ failed attempts to design around the claims, contrary to Federal Circuit precedent finding failure of others entitled to considerable weight. See WBIP, LLC v. Kohler Co., 829 F.3d 1317 (Fed. Cir. 2016).

Regarding industry praise, the PTAB found Team Worldwide’s evidence was entitled to some, but not considerable weight. However, Team Worldwide contended that the PTAB ignored relevant testimony praising the invention, which should be afforded considerable weight under Federal Circuit law. See Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034 (Fed. Cir. 2016) (en banc).

In sum, Team Worldwide argued that the PTAB did not properly weigh the objective evidence of nonobviousness as required under controlling Federal Circuit precedent and that this evidence outweighed the PTAB’s finding of obviousness.

Unfortunately, on appeal the Federal Circuit did not take the time to work through these issues but rather simply issued its R.36 Affirmance without opinion.

In addition to the general role of objective indicia, the appeal asked an important question about burdens of proof: “Did the Board err by inappropriately applying a standard of proof that required TWW to prove the validity of its claims in light of secondary considerations when the burden of proof statutorily remains with Petitioner to prove invalidity including in light of secondary considerations?”

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

Patent,

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.

“Bald Girls Do Lunch” Unable to Sway the Federal Circuit in Case Involving Deuterated Drug for Alopecia Areata

Patent

By Chris Holman

Sun Pharmaceutical v. Incyte, 2023 WL 5370639, Not Reported in Fed. Rptr. (Fed. Cir. Aug. 22, 2023)

Bald Girls Do Lunch (“BDGL”) is a nonprofit organization dedicated to improving the quality of life for females living with alopecia areata (“AA”).  AA has been described as “an autoimmune skin disease resulting in partial to complete hair loss on all hair-bearing areas of the body, including, for example, on the face, resulting in loss of eyebrows and eyelashes.” According to BDGL, “AA is not a simple cosmetic problem—it is a chronic, often devastating condition that has substantial and wideranging implications, affecting patient’s physical, mental, and emotional health.  Indeed, in severe cases, AA can lead to chronic depression.”

On August 22, the Federal Circuit issued a nonprecedential opinion in the case of Sun Pharmaceutical v. Incyte affirming an IPR decision that struck down as obvious all the claims in a patent directed towards a promising new treatment option for AA.  The patent is directed towards certain deuterated derivatives of ruxolitinib.  Ruxolitinib is a JAK1/JAK2 inhibitor “currently approved for the treatment of patients with intermediate or high-risk myelofibrosis.”  Deuteration involves replacing one or more hydrogen atoms of a drug with deuterium, an isotope of hydrogen, to slow the CYP-mediated metabolism of a drug or to reduce the formation of undesirable metabolites, which can result in improved safety, tolerability, or efficacy.  The claims encompass an octo-deuterated ruxolitinib analog identified as “CTP-543,” a potential treatment for AA that has been granted “Fast Track” and “Breakthrough Therapy” designations, which means that FDA will expedite its review as a new drug.

BDGL filed an amicus curiae brief in support of the patent owner, Sun Pharmaceutical, which focuses on one specific aspect of the Patent Trial and Appeal Board’s decision, i.e., the Board’s evaluation of one of the objective indicia of nonobviousness, “long-felt but unsolved need.” The Board found that while CTP-543 has the “potential” and “likelihood” of satisfying the need for an effective treatment for AA, as of now it has not actually satisfied the need for an FDA-approved treatment for AA, because it has yet to receive FDA marketing approval.

In its brief, BDGL argues that in 2012, at the time of the patent’s effective filing date, there was a long-felt, unmet need for a new treatment option for AA. No FDA-approved AA treatment existed, and off-label treatments were ineffective or not tolerable long-term, or both, and many caused unwanted side effects, ranging from unpleasant or undesirable to potentially serious. BDGL argues in its brief that the proper time for assessing the presence of a long-felt, unmet need is at the time of patent filing, and that the determination of whether that need has been satisfied should be based on the treatment as claimed in the as-filed patent application, not upon a marketed product embodying the patented invention. The organization points to the FDA’s decision to grant CTP-543 expedited review status as evidence of the long-felt, unmet need for treatment for AA patients, as well as positive results in completed Phase 3 clinical trials.

BDGL’s brief concludes by warning that the Board’s approach “threatens to upend the well-established obviousness analysis – solely with respect to patents on technology that requires premarket regulatory approval such as pharmaceutical patents – and threatens to impede the development of innovative pharmaceutical treatment necessary to care for patients, particularly for patients suffering from conditions for which no treatment otherwise exists.”

A unanimous panel of the Federal Circuit was not persuaded, however, upholding the Board’s determination with respect to objective indicia as well as its ultimate conclusion that all of the claims were obvious. The Federal Circuit explained:

Assuming, without deciding, that the need for an effective and safe alopecia areata treatment existed, the Board had substantial evidence for its finding that CTP-543 had not actually satisfied this long-felt need, but only had the “potential” and “likelihood” to do so. While we agree with Sun (and amicus Bald Girls Do Lunch) that FDA approval is not a prerequisite to showing that a long-felt need has been met, and FDA’s designation of CTP-543 for “Breakthrough Therapy” and “Fast-Track” approval are probative of nonobviousness, here Sun expressly framed its objective indicia argument as “CTP-543 satisfies the long-felt need for an FDA-approved, evidence-based alopecia areata treatment,” (emphasis added), and the Board reasonably found that CTP-543 had not met this need because it lacked FDA approval.  Thus, substantial evidence supports the Board’s conclusion that Sun did not prove that CTP-543 has satisfied this long-felt need.

Note the emphasis that the Federal Circuit places on Sun Pharmaceutical’s decision to frame the issue on appeal as whether CTP-543 had satisfied the need for an “FDA-approved” AA treatment, seeming to suggest that the outcome might have been different if Sun Pharmaceutical had simply argued that the drug had satisfied the need for a new treatment option for AA, without any explicit mention of FDA approval.  In a footnote, the court specifically notes that “evidence provided by the amicus, Bald Girls Do Lunch, but not otherwise in the record cannot be considered on appeal.”

Sun Pharmaceutical v. Incyte raises the question of whether deuterated analogs of prior art compounds will generally be found obvious. I suspect that the answer is no, and as is the case with claims directed towards enantiomers, the determination will be fact-dependent and made on a case-by-case basis. In this particular case, the Board found that the prior art references of record (which included a marketing publication issued by Concert Pharmaceuticals, the original owner of the patent) disclosed (1) that ruxolitinib is a promising drug candidate; (2) that deuteration of compounds provides the potential for improved safety, better tolerability, and enhanced efficacy; and (3) the specific locations of certain metabolic “hotspots” on ruxolitinib, which are the sites on a compound were oxidative metabolism occurs during in vivo metabolism. These “hotspots” correspond to the locations where the compounds claimed in the patent are deuterated.

I can imagine scenarios in which a deuterated analog of a prior art compound might be deemed nonobvious. For example, if the prior art did not provide sufficient motivation to deuterate the particular compound at issue, or did not identify specific metabolic “hotspots” as likely locations for deuteration. Or in some cases a court might find that there was not a reasonable likelihood of success in creating or using a particular deuterated compound.

Fortunately, this was a nonprecedential decision. Given the length of time that generally elapses between the filing and issuance of a patent and FDA approval of the corresponding patented compound, a determination of obviousness will often occur prior to FDA marketing approval. Would the outcome in this case have been different if FDA had approved CTP-543 during the intervening time between the Board decision and the Federal Circuit’s decision? If the FDA does eventually approve CTP-543, will Sun Pharmaceuticals have any avenue to revisit the issue in the courts or the PTO?

 

PTAB Captains Take Notice: Carefully Weigh Secondary Considerations

Patent

By Dennis Crouch

The nexus requirement serves as a threshold that must be met before secondary indicia will be even considered as relevant to the obviousness inquiry.  In its recent Volva Penta decision, the Federal Circuit found that the PTAB had  (1) created too high of a burden to prove nexus and (2) been unduly dismissive of the patentee’s evidence of commercial success and copying.  The case reinforces the notion that patentees should attempt to include some claims that are largely coexistive with its product line, especially in today’s world of likely copying. The case also serves as a reminder that product copying still caries significant weight in the obviousness analysis. Volvo Penta of the Americas, LLC v. Brunswick Corp., 22-1765, — F.4th — (Fed. Cir. August 24, 2022).

For several years, Volvo Penta has been selling a boat engine drive where the propellers are forward facing and thus tucked under the boat. The setup, known as a tractor-type stern drive, pulls the boat forward rather than traditional rear-facing propellers that push.  The drive has been a commercial success, especially for boats with nearby swimmers because the forward facing propellers offer potential safety advantage.

In 2020, Brunswick launched a competing product under its Mercury brand and, on the same day as its product launch also filed an IPR petition challenging Volvo’s US Patent 9,630,692.  The PTAB granted the petition and ultimately sided with the petitioner by holding that the claims would have been obvious based upon a combination of the prior art references.   On appeal, however, the Federal Circuit has vacated and remanded–ordering the PTAB to take a fresh look at the secondary indicia of nonobviousness such as commercial success and copying.

Obviousness analysis primarily focuses on comparing the claimed invention against the prior art and using that consideration to guess whether the gap would have been obvious to fill at the time of the invention.  But, the

Obviousness analysis primarily focuses on comparing the claimed invention against the prior art and using that consideration to guess whether the gap would have been obvious to fill at the time of the invention. But, the analysis should not end there. Secondary indicia of nonobviousness, also referred to as objective evidence, provide real-world, albeit indirect insights into the obviousness determination. Evidence of commercial success, long-felt but unsolved need, failure of others, industry praise, and copying can indicate that an invention was not obvious to those skilled in the art at the time, even if it appears so in hindsight. While secondary considerations do not control the obviousness conclusion, they must be considered as part of the totality of the evidence when presented by the patentee.  At times, the objective evidence is considered the most probative and cogent evidence of nonobviousness.

In recent years, the courts and patent office have been restricting the use of objective evidence of nonobviousness by applying a tight nexus requirement.  Before the evidence is given any consideration, the patentee must show a nexus between the invention as claimed and the objective evidence of nonobviousness.  This nexus requirement is designed to ensure, for instance, that commercial success is due to qualities of the invention being patented rather than some other advance or perhaps simply marketing.  Nexus can be established via a presumption when the evidence is tied to a product that embodies and is coextensive with the claims. Brown & Williamson Tobacco Corp. v. Philip Morris, Inc., 229 F.3d 1120 (Fed. Cir. 2000). Even without a presumption, nexus can be shown by tying the evidence to the “unique characteristics of the claimed invention.” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366 (Fed. Cir. 2019). The patent owner bears the burden of establishing nexus. WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339 (Fed. Cir. 1999). Nexus is not limited to only novel features, but considers the invention as a whole. Chemours Co. FC, LLC v. Daikin Indus., Ltd., 4 F.4th 1370 (Fed. Cir. 2021).

Here, the PTAB found that Volvo Penta was not entitled to a presumption of nexus between the claims and the objective evidence. It held that even though the Forward Drive and Bravo Four S embodied the claims, Volvo Penta did not provide sufficient arguments regarding coextensiveness. The PTAB also found that Volvo Penta did not otherwise demonstrate nexus by identifying the unique characteristics or merits of the claimed invention tied to the objective evidence presented.

On appeal, the Federal Circuit vacated.  The court noted that Volvo Penta expressly argued the commercial success of the Forward Drive was tied to the “steerable tractor-type drive” recited in the claims. Volvo Penta cited internal Brunswick documents discussing the need to match the capabilities of the Forward Drive in developing the Bravo Four S. This demonstrated a nexus between the Pulling-type stern drive in the claims and the objective evidence.  While Volvo Penta’s arguments on coextensiveness may have been fairly minimal, the court found them sufficient to show nexus by tying the evidence to the specific claimed feature of a tractor-type stern drive. The undisputed evidence showed boat manufacturers strongly desired this feature in Volvo Penta’s product. Thus, the Federal Circuit found Volvo Penta established the required nexus between the claims and objective evidence.

The Federal Circuit also determined the PTAB’s analysis and weighing of the objective evidence was deficient in several ways.

First, the court found the PTAB’s assignment of “some weight” or “very little weight” to the various secondary considerations was overly vague. This was problematic even if the individual weights were supported, because the PTAB provided no insight into its summation finding that collectively the evidence only “weighed somewhat” in favor of nonobviousness. As the court noted, it is unclear whether “some weight” has the same meaning across different factors.

Second, for certain factors like copying, the PTAB’s assignment of weight contradicted its own factual findings. The PTAB found evidence showing Brunswick copied the Forward Drive in developing its competing Bravo Four S product. However, despite noting that copying is usually considered “strong evidence” of nonobviousness, the PTAB only gave copying “some weight.” This  seeming inconsistency was not explained by the PTAB in its final written decision.

Third, the PTAB dismissed or overlooked aspects of the evidence related to long-felt need, praising comments, and commercial success, and the appellate panel found that those potential gaps might have altered the weight designation.  On these points, the court cited cases focusing on the PTAB’s duty to explain and support its factual and legal conclusions. See, e.g., Pers. Web Techs., LLC v. Apple, Inc., 848 F.3d 987 (Fed. Cir. 2017) (remanding in view of the Board’s failure to “sufficiently explain and support [its] conclusions”); In re Nuvasive, Inc., 842 F.3d 1376 (Fed. Cir. 2016)(same).

The Federal Circuit’s decision in Volvo Penta provides important guidance for patent applicants and owners seeking to overcome obviousness challenges. It reemphasizes potentially important role that objective evidence plays in the obviousness determination, and shows that the nexus requirement should not be applied overly restrictively. While patentees must establish nexus, a limited amount of support tying the objective evidence to the claimed invention as a whole can be sufficient.  The court also makes clear that the PTAB must fully and fairly consider all relevant objective evidence, avoid ambiguous weighing, and sufficiently explain any dismissal or discounting of probative evidence. Vague labels like “some weight” are unhelpful. Findings that contradict the evidence, like affording copying only minimal weight, will draw enhanced scrutiny.

Size Matters: Element-by-Element Analysis in Obviousness

Patent,

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

Three issues: Law/Fact Distinction in Obviousness; Envisaging the Invention; and Newman in Dissent

Patent

by Dennis Crouch

Incept LLC v. Palette Life Sciences, Inc., No. 21-2063 (Fed. Cir. Aug. 16, 2023) (Majority by Judges Schall and Taranto; Dissent-in-part by Judge Newman)

The most interesting line in the case for appellate attorneys (and legal scholars) is probably the court’s law/fact distinction in the context of obviousness analysis.  The majority wrote: “We see no reversible error … whether viewed as a factual one about the level of [commercial] success or a legal one about the weight of any such success in the overall obviousness analysis.”  The law/fact divide is important because of the evidentiary requirements in the first instance and the standard for review on appeal. Here, the court makes clear that the weight given to any objective indicia of non-obviousness is a question of law rather than a question of fact.  The result then is that its analysis can generally be based upon reason rather than evidence, and that issue is one that will be heard de novo on appeal.

The second issue of importance is as another data point in the forest-trees  anticipation analysis in situations where the prior art discloses thousands of potential embodiments.  The court has repeatedly held that such a reference is only anticipatory if a person of skill would have immediately envisaged the invention now being claimed.  In this case, the court took a relatively broad view of what constitutes anticipation — focusing on the level of specificity in the claims and guideposts such as the purpose of various elements in the claim.  In the end, the patentee lost and the claims were found invalid.

Finally, the case includes another dissent from Judge Newman.

= = =

Incept’s patents cover a method for treating cancer that involves injecting a biodegradable filler gel prior to radiation treatment in order to increase space between the the tissue being treated and the closest body organs.  Afterwards, the gel biodegrades and so does not need to be removed. U.S. Patent Nos. 8,257,723 and 7,744,913.  Palette Life Sciences initiated IPR proceedings and the PTAB eventually found the challenged claims unpatentable as anticipated/obvious.  On appeal, the Federal Circuit has affirmed with Judge Newman offering a partial dissent. The dependent claims include various forms of the filler, such as thixotropic polymer, collagen, a polysaccharide, or hyaluronic acid.

Wallace discloses millions of possible compositions, and the patentee argued that the Board engaged in improper retrospective construction of the invention by picking and choosing various elements from the disclosure.  The idea then is that one skilled in the art could not have “at once envisaged” the various species claimed by Incept.  On appeal, the majority sided with the Board, holding that “Wallace expressly describes compositions that have the claimed characteristics of, and are used for the same displacement purpose as, the compositions referred to in the ’723 patent claims challenged as anticipated.”

Incept cannot use the fact that Wallace describes multiple compositions to evade an anticipation finding where Wallace provides “as complete detail as is contained in the patent claim,” such that a skilled artisan would have understood that Wallace’s compositions had the same generic properties as those in the ’723 patent claims.

In her opinion, Judge Newman took the majority to task for ignoring limitations in narrower dependent claims.

The majority appears to hold that, when the broader claim is anticipated, the dependent claims are automatically anticipated. That is not the law. Each claim must be considered as a whole, including all its limitations. . . . A generic prior disclosure does not anticipate all of its embodiments, including novel specific embodiments, whether or not the facts are such that the generic disclosure may render the embodiment obvious.

The problem with Judge Newman’s arguments here is that the patentee only barely argued the dependent claims, and the majority recognizes this at least to most of the dependent claims – noting that Incept had failed to provide specific arguments directed to those claims.

Other claims were found obvious by the PTAB and the majority again affirmed that holding. The patentee had provided evidence of commercial success — showing that most prostate cancer treatments in the US used an injectable  known as “SpaceOar” exclusively licensed from the patentee.  The Board refused to give any weight to the commercial success because the sales numbers provided included free and replacement versions, without accounting for those numbers.   In addition, the Board found the patentee’s expert testimony not credible and not supported by evidence.

Judge Newman’s dissent noted that “It is undisputed that the Incept product
experienced regular increases in annual commercial sales, and at the time of trial Incept had obtained 55% of the market for comparable products. Palette’s only criticism of Incept’s commercial information was that Incept also gave free samples. The majority now holds that Incept’s commercial sales cannot be considered as a measure of commercial success because some product was provided free of charge.”

= = =

Independent claim 1 of the ’723 patent recites:

1. A method of delivering a therapeutic dose of radiation to a patient comprising

introducing a biocompatible, biodegradable filler between an organ and a nearby tissue to increase a distance between the organ and the tissue, and

treating the tissue with the therapeutic dose of radiation so that the presence of the filler causes the organ to receive less of the dose of radiation compared to the amount of the dose of radiation the organ would receive in the absence of the filler,

wherein the filler is introduced as an injectable material and is a gel in the patient, and

wherein the filler is removable by biodegradation in the patient.

 

Shamoon v. Resideo: Obviousness affirmed

Patent

by Dennis Crouch

Shamoon v. Resideo Technologies, Inc., No. 2021-1813 (Fed. Cir. Aug. 8, 2023) (opinion by Judge Newman; joined by Judges Reyna, and Cunningham) (non-precedential)

Charles Shamoon is the inventor and owner of U.S. Patent No. 8,064,935. The patent relates to a remote access system that allows users to monitor and control “environmental devices” like alarm and HVAC systems in their home using a base control unit and a remote unit.  Resideo challenged the patent in a pair of IPR petitions, and the PTAB eventually found the challenged  claims unpatentable as obvious over a combination of two/three prior art references.

On appeal, the Federal Circuit affirmed and rejected Shamoon’s three challenges.

The claims require a microcontroller, and Shamoon argued that the term should be construed as requiring a particular type of microcontroller that included certain memory elements. That narrowed definition might have helped Shamoon avoid the prior art.  But, the Federal Circuit upheld the PTAB’s broad claim construction of “microcontroller” — finding that it was broadly used both in the claims and the specification.

Some of the claims required a confirmation message be sent once an instruction had been executed, and Shamoon argued that the prior art failed to teach a confirmation message related to an environmental device command.  On appeal though, the court found that it was proper to combine the teaching of a confirmation message from a reference not related to environmental devices.  “Because Oinonen and Whitley disclose the environmental devices and  commands, it does not avail Mr. Shamoon to complain that Menard does not.” Slip Opinion.  Shamoon’s argument here

Finally, Shamoon argued that applying AIA proceedings to his pre-AIA patent was impermissible taking by the United States without just compensation, in violation of the Fifth Amendment.  The court quickly rejected this argument based upon its prior precedent in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019) (“retroactive application of IPR proceedings to pre-AIA patents is not an unconstitutional taking under the Fifth Amendment.”).

Federal Circuit’s Sleepy Obviousness Decision and Vanda’s En Banc Rehearing Petition

Patent,

by Dennis Crouch

Documents: FedCir Vanda Decision; Vanda EnBanc Brief

The Federal Circuit recently sided with the accused infringers Teva and Apotex, affirming the invalidation claims from four Vanda patents covering methods of using tasimelteon to treat circadian rhythm disorders. However, the patent owner has petitioned the court for en banc rehearing, arguing the panel improperly disregarded evidence of nonobviousness.  Responsive briefing from the generics are due on August 1.

This case provides an interesting look at the application of the obviousness standard to pharmaceutical treatment methods.

Background: Vanda Pharmaceuticals owns patents covering use of the drug tasimelteon to treat Non-24-Hour Sleep-Wake Disorder (Non-24), a condition caused by lack of synchronization between a person’s circadian rhythm and the 24-hour day. Tasimelteon is sold under the brand name Hetlioz and has over $100m in annual sales. Several generic drug makers, including Teva and Apotex, filed Abbreviated New Drug Applications (ANDAs) with the FDA seeking to market generic versions of tasimelteon and with allegations. Vanda sued, alleging infringement of four patents that were listed in the Orange Book. RE46604 (Claim 3); US10149829 (Claim 14); US9730910 (Claim 4); US10376487 (Claim 5). The district court found all asserted claims obvious based on prior art teachings about tasimelteon and related drugs. Vanda appealed.

In a May 2023 decision, the Federal Circuit affirmed the invalidity ruling. The panel found no error in the district court’s determination that the prior art would have provided a reasonable expectation of success for the claimed inventions.

Key Aspects of the Federal Circuit’s Obviousness Analysis

The inventions here involved fairly narrow differences, and the Federal Circuit concluded that a PHOSITA would have seen a reasonable expectation of success:

  • Administering without food: There was a motivation to try and a reasonable expectation of success here since FDA guidance recommended food studies, and there are just two potential options (with or without food).  There result here is close to a per-se obviousness ruling.
  • 20 mg dose to “entrain patients”: The prior art disclosed 20 mg dose and suggested entrainment.  Still obvious even though the prior study results (Rajaratnam) were not statistically significant.  In a different patent application, Vanda had characterized Rajaratnam as showing that an oral dose of 20 mg was effective.  The court also noted that an ongoing clinical trial at the time was testing 20 mg — further contributed to the expectation of success.
  • Avoiding Co-administration with CYP enzyme inhibitors: A similar drug (ramelton) had shown problems with co-administration with these CYP enzyme inhibitors, creating a reasonable expectation that tasimelteon would also show similar results. On this point, the testimony was that PHOSITA would not have “ruled out an interaction.”

The key with all of these is reliance on KSR‘s flexible approach and expanded use of the reasonable expectation of success standard.  Although Vanda argued objective indicia, it was given very little consideration by the appellate panel.

Vanda’s Petition for Rehearing En Banc

Vanda’s en banc brief asks three questions:

  1. With or Without Food: Whether method-of-treatment patents directed to the effect of food on a particular drug are per se obvious because of FDA Guidance acknowledging that food may affect the bioavailability of drugs and should be studied.
  2. Clinical Trial as Evidence of Reasonable Expectation of Success: Whether a disclosure showing existence of an ongoing clinical trial is evidence of a reasonable expectation of success as to the result of the trial.  See OSI Pharms v. Apotex (Fed. Cir. 2019) (clinical trial provides only hope, not expectation of success).
  3. Results from Similar Drug: Whether a drug-drug interaction patent is obvious when a POSA could not “rule out” the interaction because another compound in the same general category has shown such an interaction.

The petition urges the full Federal Circuit court to take the case en banc to maintain uniformity of obviousness precedents. I’m sure that companies in the life sciences sector will be closely watching this case as it continues to unfold.

Stay on Target: Proper Obviousness Analysis Requires Focus on Claimed Invention

Patent, ,

by Dennis Crouch

If you break it down far enough, every invention is simply a combination of known materials or steps. In that frame, the obviousness inquiry fundamentally becomes a question of whether the combination of known elements was within the toolkit of an ordinary artisan. This is a flexible analysis (KSR) with the PTO and courts typically looking for a “motivation to combine” the prior art teachings that would have a “reasonable expectation of success.”

The Federal Circuit’s recent decision in Axonics, Inc. v. Medtronic, Inc., No. 2022-1451 (Fed. Cir. July 10, 2023) zeroes in on the motivation-to-combine analysis. In Axonics, the court ruled that the obviousness analysis must focus on the motivation to combine references to reach the claimed invention, not motivation to combine for some other purpose described in the prior art. The basic outcome is that it will prevent overly narrow framing of the motivation inquiry by the PTAB.

Medtronic has two patents that cover medical leads for nerve stimulation. Importantly for the case, although the claims appear broad enough to cover trigeminal nerve stimulation, they are not limited to that type of stimulation. Axonics IPR challenged the claims as obvious based upon two key prior art references: Young and Gerber. The Young patent relates to a lead for stimulating the trigeminal nerve, while the Gerber patent relates to a lead with a plurality of electrodes. Together, the two references taught all of the limitations found in the Medtronic claims. However, the PTAB concluded that an artisan would not have been motivated to combine the references. The PTAB started with Young’s focus on the trigeminal nerve stimulator, and found that the proposed addition of Gerber would fail to work for trigeminal nerve stimulation based on the anatomy of that area.

On appeal, the Federal Circuit found that the PTAB improperly limited the Young-Gerber combination analysis to what would work in the trigeminal-nerve area, which is a requirement of the Medtronic patents’ claims. The proper inquiry should have been whether the relevant artisan would be motivated to make the combination to arrive at the claims’ actual limitations, which are not limited to the trigeminal-nerve context. The Federal Circuit also found that the PTAB erred in its definition of “the relevant art” as limited to medical leads for sacral-nerve stimulation, as the Medtronic patent claims make no reference to sacral anatomy or sacral neuromodulation, and they cannot be properly construed as so limited.

This holding indicates that the PTAB cannot improperly narrow its view of the relevant art based on specification details not reflected in the claims. Rather, the relevant art must align with the scope of the claimed invention. The decision also underscores that the motivation analysis must focus on combining prior art to reach the claimed invention, not suitability for a specific context described in one reference.

I’ll note here that Judge Taranto justifies the decision with a statement about how the patent is not directed to sacral nerfes:

No claim of the two patents either mentions or is limited to sacral nerves. The same is true of the titles of the two patents.

I’ll note here that the rest of the patent is ripe with a focus on sacral nerves.  As an example, the  following comes from the background section:

This invention relates generally to a method and apparatus that allows for stimulation of body tissue, particularly sacral nerves. More specifically, this invention relates to an implantable medical electrical lead having at least one stimulation electrode adapted to be implanted near the sacral nerves for stimulation of a bundle of sacral nerve fibers and a fixation mechanism for providing chronic stability of the stimulation electrode and lead. Moreover, this invention relates to the method of implantation and anchoring of the medical electrical lead electrodes in operative relation to a selected sacral nerve to allow for stimulation.

Id.

On remand, the Board will need to take a fresh look at the Young-Gerber combination. But, it isn’t clear that the result will be obviousness since we still need to know whether someone of skill in the art would have some reason to believe they could to take the trigeminal nerve stimulator disclosed in Young; and combine it with plurality of electrodes disclosed in Gerber to make a non-trigeminal version covered by the claims.

= = =

What is the invention? Traditionally, an invention requires reduction to practice; an actual embodiment.  And, although we have long permitted patent filings as an alternative, the law sees that as merely a constructive stand-in for the real thing.  At the same time, we have all heard the patent law maxim that an invention is defined be the scope of the claims. And, in 2011 the patent laws were finally amended to reflect that paper-focused framework by focusing attention on “the claimed invention” rather than just “the invention.”   The amended law now requires an analysis of the “the differences between the claimed invention and the prior art” and whether “the claimed invention as a whole would have been obvious.”   This was a subtle change, but one that fundamentally shifted focus from the historic framework of an invention that required reduction to practice toward the paper version that defines the invention in terms of what is claimed.

The difficulty for Medtronic in this case is that they took the original invention that focused on sacral nerves and decided to expand out the scope beyond that reach. (The company holds other patents in the family that do focus on sacral nerve stimulation).

Reevaluating Design Patent Obviousness

Patent,

by Dennis Crouch

Design patents continue to rise in importance, but the underlying law full of eccentricities.  The crux of the issue lies in the manner patent law decisions are typically written. Most of precedential patent decisions are penned with a strong focus on utility patent doctrine, yet, surprisingly, the same patent doctrines of novelty, obviousness, definiteness, enablement, and written description are also applicable in the realm of design patents.

The Federal Circuit has decided to reevaluate this dichotomous situation specifically in relation to the question of obviousness. The case under scrutiny is LKQ Corp. v. GM Global Tech, 21-2348 (Fed. Cir. 2023). The court has set forth six key questions for the parties to consider:

A. Does KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), overrule or abrogate In re Rosen, 673 F.2d 388 (CCPA 1982), and Durling v. Spectrum Furniture Co., Inc., 101 F.3d 100 (Fed. Cir. 1996)?

B. Assuming that KSR neither overrules nor abrogates Rosen and Durling, does KSR nonetheless apply to design patents and suggest the court should eliminate or modify the Rosen-Durling test? In particular, please address whether KSR’s statements faulting “a rigid rule that limits the obviousness in-quiry,” 550 U.S. at 419, and adopting “an ex-pansive and flexible approach,” id. at 415, should cause us to eliminate or modify: (a) Durling’s requirement that “[b]efore one can begin to combine prior art designs . . . one must find a single reference, ‘a something in existence, the design characteristics of which are basically the same as the claimed design,’” 101 F.3dat 103 (quoting Rosen, 673 F.2d at 391); and/or (b) Durling’s require-ment that secondary references “may only be used to modify the primary reference if they are ‘so related to the primary reference that the appearance of certain ornamental fea-tures in one would suggest the application of those features to the other,’” id. at 103 (quot-ing In re Borden, 90 F.3d 1570, 1575 (Fed. Cir. 1996)) (internal alterations omitted).

C. If the court were to eliminate or modify the Rosen-Durling test, what should the test be for evaluating design patent obviousness challenges?

D. Has any precedent from this court already taken steps to clarify the Rosen-Durling test? If so, please identify whether those cases resolve any relevant issues.

E. Given the length of time in which the Rosen-Durling test has been applied, would eliminat-ing or modifying the design patent obviousness test cause uncertainty in an otherwise settled area of law?

F. To the extent not addressed in the responses to the questions above, what differences, if any, between design patents and utility patents are relevant to the obviousness inquiry, and what role should these differences play in the test for obviousness of design patents?

En Banc Order.

The case itself involves design patents covering GM parts, such as front fenders.  See D797,625.  The existence of the design patent means that repair parts must come from authorized manufacturers and channels.  For years, auto insurance companies and others have argued that this improperly raises costs.

The original appellate decision was non-precedential and supported the PTAB IPR decision that the patent challenger failed to demonstrate obviousness. The court relied on the tests delineated in Rosen & Durling, putting a spotlight on a primary reference that ought to be “basically the same” as the claimed design. Notably, this is a substantially different approach than the one employed in utility patent obviousness doctrine.

The original panel was composed of Judges Lourie, Clevenger, and Stark. Though the panel released a per curium opinion, separate opinions were also issued by Judges Lourie and Stark. Judge Lourie expressed his conclusion that it is totally acceptable for the design patent obviousness test to be different from that in utility patents. “Obviousness of an ornamental design thus requires different considerations from those of a utility invention.”  Judge Stark disagreed with the majority opinion on a procedural grounds (forfeiture of certain arguments).

Barry Irwin teamed up with Profs Mark Lemley and Mark McKenna for the en banc petition. Joseph Herriges and John Dragseth from Fish & Richardson represent GM.

The court specifically invited the US Gov’t to file an amicus brief and also welcomed additional briefs of amicus curiae — noting that they “may be filed without consent and leave of the court.”  If you support LKQ (making it easier to invalidate design patents), amicus briefs will be due in late August.  If you support GM, briefs will be due in late September.