In CareDx v. Natera, an intriguing amicus brief was recently filed by the Honorable Paul Michel (Ret.) and Professor John Duffy in support of the patentee petitioners Stanford and CareDx. The brief advocates for the clarification of patent-eligibility law, and criticizes the Federal Circuit’s handling of the case. The filing of the brief has seemingly prompted the Supreme Court to request a response from the accused infringers, after they initially waived their right to do so. This move reflects some significance of the arguments presented in the brief. [Read the Brief]
According to Michel and Duffy, the Federal Circuit’s decision in the case overlooked the text of the Patent Act and conflicts with Supreme Court precedent such as Diehr and Cochran v. Deener. They argue that the decision fails to recognize the difference between patent eligibility (under § 101) and patentability (under §§ 102, 103, and 112). They further criticize the decision for an unduly simplified description of the invention that leaves out important details and for improper emphasis on “conventionality.” The concept of “conventionality” is more appropriately associated with issues of novelty and nonobviousness, as regulated by §§ 102 and 103 respectively, rather than being a key criterion for patent eligibility under § 101.
The brief spends some amount of time focusing on landmark patent cases such as Diehr and Cochrane v. Deener (while rejecting Flook) to illustrate how a process can be patent eligible despite encompassing conventional elements. And, throughout this argues that the Federal Circuit misunderstood the definition of “process,” which under 35 U.S.C. § 100(b) is defined to include “a new use of a known process.” The brief contends that this definition permits patents on new applications or improvements of known technologies, and that such improvements should be presumed to be patent eligible. But, the Federal Circuit’s eligibility criteria of “conventionality” prohibits this interpretation even though not rooted in the Patent Act’s text or the Supreme Court’s precedent.
As with other recent eligibility briefs, this one also underscores a need to address confusion and uncertainty surrounding patent eligibility, particularly in relation to biomedical and diagnostic patents.
Now that we’re almost to June, the petition is unlikely to be decided before the recess and instead will be held-over until the fall 2023 before we get a decision on whether the court will grant certiorari.
The most recent enablement case invoked by the Supreme Court in Amgen is Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245 (1928). The Court also referenced several other historically significant enablement cases, including Wood v. Underhill, 5 How. 1 (1846); The Incandescent Lamp Patent, 159 U. S. 465 (1895); and Minerals Separation, Ltd. v. Hyde, 242 U. S. 261 (1916). The Court went to lengths to present O’Reilly v. Morse, 15 How. 62 (1854), as an enablement decision, even though in both Alice and Mayo, the court had labeled O’Reilly as an eligibility decision. The approach of Amgen echoes that of the Supreme Court’s 2010 Bilski decision, which advised a simple adherence to established precedents. The only non-Supreme Court decision that Amgen cites is Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813). Notably, Whittemore was adjudicated by Supreme Court Justice Joseph Story while on circuit duty.
In looking at the leading Supreme Court precedent case of Holland Furniture, it is telling that the Federal Circuit has invoked this case only twice – in both instances, for discussions regarding means-plus-function claim interpretation, not enablement. Nevertheless, Holland Furniture remains a crucial decision that precludes (a) genus claims built upon on the disclosure of a single species, as well as (b) genus claims that encompass inoperable species. The case involved a patent covering starch-based glue. The Supreme Court explained “an inventor may not describe a particular starch glue which will perform the function of animal glue and then claim all starch glues which have those functions, or even all starch glues made with three parts of water and alkali, since starch glues may be made with three parts of water and alkali that do not have those properties.” Id. The Federal Circuit’s failure to rely upon Holland Furniture likely stems from the fact that the case served as the foundation for Walker v. Halliburton that was later rejected by the 1952 Patent Act.
Elephants in the Room: The Federal Circuit has adjudicated numerous biotech enablement cases, providing nuanced analysis, none of which was cited or dissected by the Supreme Court. Perhaps the simply have a tit-for-tat since the Federal Circuit so rarely cites the Supreme Court in enablement cases. The appellate court’s Amgen decision, for instance, cited many Federal Circuit opinions, but nothing from the Supreme Court. In many ways, the two courts are simply talking past one another without disagreeing.
A critical case absent from the Supreme Court’s Amgen analysis is In re Wands, 858 F.2d 731 (Fed. Cir. 1988). In Wands, the Federal Circuit introduced a set of factual considerations to assess whether a claim is sufficiently enabled or would necessitate undue experimentation – a key factor is the amount of experimentation required. In Amgen, these elements were handed to the jury for adjudication as mandated by the 7th Amendment. The jury in Amgen sided with the patentee, deeming the claims enabled. However, this pro-patentee verdict was overturned by the district court on JMOL, a decision subsequently affirmed by both the Federal Circuit and the Supreme Court. In its deliberation, the Supreme Court seems to reassess the Wands factors de novo without acknowledging the jury’s verdict. Intriguingly, the Supreme Court’s opinion finds substantial experimentation necessary, but does not even acknowledge the existence of a jury verdict, simply stating that “both the district court and Federal Circuit sided with Sanofi.” This omission marks a significant oversight by the Court.
While the Supreme Court’s decision in Amgen v. Sanofi seems to generally affirm the current approach of the Federal Circuit to enablement, it lacks any depth of engagement with the nuanced analysis often conducted by the Federal Circuit. In particular, the absence of reference to In re Wands and its eight-factor test, is a surprising omission. Even more disconcerting is the Court’s disregard for the jury’s verdict in the original Amgen trial, reflecting a potential underappreciation of the complexities of patent law and the factual determinations involved. It remains to be seen how this lack of engagement with Federal Circuit precedent may influence future patent law decisions. Most likely, the Federal Circuit will continue its historic approach implicitly suggested by Prof Holman and continue to ignore the Supreme Court precedent on point.
The case involving Medtronic and Teleflex centered on five patents related to a coaxial guide catheter used in interventional cardiology procedures. These patents, US Patents 8,048,032, RE45,380, RE45,776, RE45,760, and RE47,379, cover inventions devised to offer an “enhanced backup support” in contrast to using a guide catheter individually.
In an attempt to invalidate these patents, Medtronic launched a succession of Inter Partes Review (IPR) petitions. Despite the initial approval of the petitions, the Board eventually ruled in favor of Teleflex, the patent holder. The pivotal question on appeal was whether U.S. Patent 7,736,355 (“Itou”) could be regarded as prior art.
In a split decision, the Federal Circuit confirmed the Board’s decision, establishing that the first-to-invent law from before the America Invents Act (AIA) allowed Teleflex to antedate the prior art by demonstrating prior invention. The case underlines a situation where the transition to the AIA has resulted in the loss of certain rights for patent holders. Under the AIA’s provisions, Itou would have been considered prior art, therefore preventing Teleflex’s patenting. The also case stands out as Itou was clearly the first inventor, but this evidence was not taken into account due both to arcane pre-AIA rules and due to the IPR process focusing only on the published patent documents.
Teleflex’s patents claim a priority filing date of May 3, 2006, based on a purported conception date in early 2005. Itou’s priority application was filed in Japan in September 2004, and a year later, the US application was filed on September 23, 2005. Despite Itou pioneering the invention in Japan and filing the Japanese patent application prior to Teleflex’s invention, Teleflex arguably demonstrated an invention date that preceded Itou’s US filing date, which was critical for the court’s decision.
A crucial regulation in this context is pre-AIA 102(e), which introduces a form of ‘secret prior art’ for patent applications that are unpublished as of the patentee’s invention date. Under this regulation, a third party’s US or PCT patent application becomes prior art once published. However, the quirk of 102(e) as compared to pre-AIA 102(a) lies in the fact that these applications are treated as prior art from their filing date, not their publication date. An important subtlety is that a foreign patent filings, like Itou’s Japanese application, do not qualify as prior art under 102(e). In re Hilmer, 149 USPQ 480 (CCPA 1966).
Proving Prior Invention: The concept of ‘invention date’ is crucial in pre-AIA patent cases, and typically, this date is assumed to be the filing date of the patent application. The patentee can then furnish evidence to establish an earlier date of invention, which usually involves a sworn declaration from the inventor, corroborated by additional evidence. Perfect Surgical Techs., Inc. v. Olympus Am., Inc., 841 F.3d 1004 (Fed. Cir. 2016).
Both the Patent Trial and Appeal Board (PTAB) and the majority judges (Judge Lourie and Chief Judge Moore) concurred that Teleflex had provided adequate evidence to substantiate an earlier invention date. Judge Dyk, however, wrote in dissent.
It’s important to understand that the process of invention involves two steps – conception and reduction to practice. The majority and dissent agreed that Teleflex had provided evidence sufficient to proven both conception and the creation of a prototype before the critical date. However, reduction to practice also necessitates evidence demonstrating the suitability of the invention for its intended purpose. For complex inventions like the one in this case, the courts can require testing to establish this suitability prong. Steinberg v. Seitz, 517 F.2d 1359 (C.C.P.A. 1975). While the majority deemed the evidence of testing adequate, the dissent argued it was insufficient — with the debate focusing on the extent of corroboration required.
The majority observed, “[B]oth inventors Howard Root and Gregg Sutton testified regarding testing performed on a prototype of the claimed invention. These tests, although more qualitative than quantitative, were sufficient to confirm that the prototype would work for its intended purpose — providing increased backup support as compared with a guide catheter alone.” The judges concurred with the Board’s view that the tests did not require a direct comparison or a quantitative analysis to prove improvement in function. They also noted expert testimony suggesting “qualitative testing would have been sufficient.”
However, Judge Dyk, dissenting, questioned the lack of corroborative evidence supporting the prior testing. He cited to Cooper v. Goldfarb, 154 F.3d 1321 (Fed. Cir. 1998), to assert that “[i]n order to establish an actual reduction to practice, an inventor’s testimony must be corroborated by independent evidence.” Judge Dyk particularly concluded that every “inventive fact” should be corroborated with evidence beyond the inventors’ testimonies.
The corroborating evidence in this case included a sales presentation and two non-inventors’ testimonies. However, Judge Dyk believed that this evidence did not provide any information regarding proof of operation for the intended purpose. Specifically, there was “no specific description of what tests were performed or the results of the tests … [or] when the tests were performed and whether they were performed before the critical date.” Dissent.
The majority responded that not every detail of reduction-to-practice needs to be independently corroborated, advocating for a rule of reason. Despite agreeing with this general principle, Judge Dyk insisted that the lack of corroboratory evidence regarding testing for the intended use couldn’t be overlooked.
Judge Dyk, in his dissent, noted the lack of internal documents from Teleflex corroborating any testing during the crucial period in 2005. “Common sense, and Teleflex’s own testimony [showing record keeping in this area], suggest that these documents would exist if testing had occurred.” Dissent. He argued requiring such documents did not created an unreasonable standard for inventors seeking to enforce a patent claim. Judge Dyk’s dissent concludes that “I think that Itou has been shown to be prior art to the patents at issue and therefore could support a determination of anticipation or obviousness.”
However, the majority, led by Judge Lourie, disagreed with the dissent and upheld the PTAB’s decision in favor of Teleflex.
The attorneys for the appellants (Medtronic) were led by Tasha Bahal from Wilmer Cutler. Representing Teleflex were attorneys from Carlson Caspers, led by Derek Vandenburg.
The Devil’s Dictionary of Patent Law and Beyond by Martin Abramson fills a long-standing humor gap in patent law. It contains diabolical definitions, hilarious cartoons, and amusing anecdotes on patent law and the general law environment in which it exists. Where there’s satire, clarity follows, and as in the original Devil’s Dictionary by Ambrose Bierce, the droll definitions in the present book have the “ring of truth.” The author has more than 40 years of IP experience and a deep knowledge of its history, so along with the patent law are showcased the little known gems of patent lore.
Also a great gift for those fortunate enough to have a patent attorney in your life.
In OneSubsea IP v. FMC Tech (Fed. Cir. 2023), the court has affirmed a district court denial of attorney fees for the successful defendant. A key holding in the case is that denial of summary judgment serves as a big flashing sign that the case is not exceptional.
OSS sued FMC back in 2015 for infringing claims found in ten different patents all relating to subsea processing of hydrocarbons (oil and gas). This includes: adding chemicals, separating water and sand from the hydrocarbons; increasing pressure; etc. The patents required a “flow diverter assembly” to “divert fluids” to and from a processing area. The parties argued about the word “divert.” In the context of the invention, the district court concluded that it required two different potential flowpaths, and that fluid flow must be forced to follow one instead of the other. And simply changing directions is not a diversion.
The two-flowpath requirement was a problem for the patentee. FMC’s accused structure just had one flowpath that passed through the processor as shown in the figure below.
The Proceedings: The district court issued its claim construction back in 2016, but rather than quickly granting summary judgment of non-infringement, it stayed the case pending outcome of parallel inter partes reviews challenging the patents’ validity. Those IPRs resulted in many of the claims being found invalid as obvious, with that determination affirmed by the Federal Circuit without opinion. In 2019, the district court lifted the stay and the case moved toward trial. The district court again refused to grant summary judgment of non-infringement. According to the transcripts, FMC’s counsel presented 3,200 pages of documents illustrating the differences between the patented claims and the accused products. Judge Bennett (S.D.Tex.) thought that depth of factual record was a bit too much for a summary judgment. “And you really think I’m going to be able to grant summary judgment on that?” Judge Bennett asked. Eventually, Judge Bennett excluded OSS’s expert testimony for misapplying its prior claim construction and granted the summary judgment of non-infringement. OSS did not appeal the dismissal.
Attorney Fees: After winning on the merits, FMC moved for attorney fees and non-taxable costs. The district court denied those costs, finding the case to be not exceptional. On appeal, the Federal Circuit affirmed, finding no abuse of discretion.
Section 35 U.S.C. § 285 permits a district court to award reasonable attorney fees to the prevailing party; with the caveat that it may only do so “in exceptional cases.” Under the 2014 decisions of Octane Fitness and Highmark, the Section 285 analysis is a flexible one with the district court having substantial discretion in its determination of whether a particular case is “exceptional” and whether fee shifting is appropriate. In this case, the court noted a “totality of the circumstances” approach should be taken on a “case-by-case” basis. The district court can consider whether the case is an outlier from others in terms of the “substantive strength of a party’s litigating position . . . or the unreasonable manner in which the case was litigated.” Octane Fitness.
Because district courts are given discretion in making these determinations, the decisions are given deference on appeal and only overturned based upon either: (1) clear error of judgment, (2) clear error in factual finding, or (3) a material error of law. (Note here, the error of law is reviewed de novo).
Deference and Successor Judges: Here, Judge Bennett stepped into the lawsuit at the very end of the case, replacing Judge Atlas who moved to senior status. On appeal, FMC argued that no deference should be given to Judge Bennett’s decision because he had not “lived with the case.” In Highmark, the Supreme Court grounded its decision to give deference to district court decisions upon the fact that district courts are much more into the weeds of the litigation and thus better positioned to judge exceptionally bad behavior. Because Judge Bennett decided the case on written record without even a hearing, FMC suggested that his decision should not be given deference. On appeal though the Federal Circuit rejected that analysis based upon caselaw from the other circuits consistently holding that deference is also given to successor judges discretionary decisions. “The successor judge receives the same deferential review on appeal as the original judge would have received.” Slip Op. Further, “FMC had ample notice that a successor judge would decide its § 285 motion and did not object.”
Exceptional Case: In looking at the exceptional case question, the appellate court concluded that FMC’s failure to achieve an early summary judgment was its own fault. Basically, the original motion for summary judgment was deemed “unpersuasive.” The appellate court then explained the importance of summary judgment denial:
When a district court, fully aware of the competing contentions of the parties, declines to end the case on summary judgment and allows a plaintiff’s case to proceed, the district court may have effectively determined that the position of the party opposing summary judgment is not objectively baseless, making it nearly impossible for the plaintiff’s case (on the issue that was the subject of the summary judgment motion) to “stand out” as lacking substance at that time.
Denial of fees affirmed.
US Patent Nos. 6,637,514, 7,111,687, 8,066,076, 8,122,948, 8,272,435, 8,281,864, 8,540,018, 8,573,306, 8,746,332, and 8,776,893.
As a member and supporter of the National Association of Patent Practitioners (NAPP), I am looking forward to the NAPP Annual Meeting and Conference scheduled for July 19-21 in Alexandria, Virginia at the USPTO Headquarters. I invite all those invested in protecting intellectual property rights to attend, especially folks who are deep in the day-to-day business of protecting patent rights. We have a remarkable line-up of speakers this year, including the USPTO Director, Kathi Vidal.
Delving deeper into the conference agenda, we kick off on July 19th with an optional tour of Old Town Alexandria, followed by expert-led discussions on a broad range of topics from the current USPTO Pilot Programs to how to protect your practice from cyber-attacks. Thursday, July 20th, will offer another full day of sessions covering everything from responding to prior art rejections, to cultivating diversity in patent law, and best practices for PTAB appeals. My patent law update is Thursday morning. Finally, on Friday, July 21st, we’ll wrap up with in-depth sessions on nonce words and means plus function, invention in the corporate environment, and patent term adjustment calculation, among other nerdy patent topics.
I particularly encourage law students to attend and take advantage of the steeply discounted rate for students and academics. It’s worth noting that attendance is free for the Judiciary and Federal Government employees such as PTAB Judges and Patent Examiners. Organizers have made arrangements for discounted accommodation at the Embassy Suites Alexandria Old Town for those who book early.
If you have not been part of NAPP, this is a wonderful opportunity to join a great organization for patent practitioners, network with industry professionals, and gain practical insights into the world of patent law. I hope to see you there!
For more information and registration, click here.
In a unanimous opinion delivered by Justice Gorsuch, the Supreme Court has affirmed the Federal Circuit’s decision invalidating Amgen’s functionally claimed genus of monoclonal antibodies. The Court held that Amgen’s patent claims were invalid due to a lack of enablement, as they failed to provide adequate guidance for making and using the claimed antibodies.
The case in question is Amgen Inc. v. Sanofi, 22-157, — U.S. — (2023) (21-757_k5g1).
Amgen’s patents cover monoclonal antibodies created by Amgen researchers which aid in reducing blood levels of low-density lipoprotein (LDL), also known as “bad cholesterol.” These antibodies inhibit the operation of a naturally occurring protein known as PCSK9, which degrades LDL receptors and contributes to high cholesterol levels. Amgen’s original patent covered antibodies having particular amino acid sequences, but later its competitor Sanofi patented another antibody with a different sequence from those disclosed and began competing. Amgen was then able to obtain the broader patents at issue here that are not tied to any particular antibody structure or amino acid sequence. Rather, the claims cover an “entire genus” of antibodies capable of binding to specific amino acid residues on PCSK9 and consequently inhibit PCSK9 activity. Amgen subsequently sued Sanofi for infringement, prompting a defense from Sanofi challenging whether these broader claims were sufficiently enabled.
The Patent Act requires that patent applicant describes the invention in explicit terms to enable any person skilled in the art to make and use the invention. 35 U.S.C. 112. Sanofi characterized the methods Amgen provided for generating additional antibodies as merely a trial-and-error process, claiming that Amgen’s patents failed the enablement requirement as they sought exclusive use over potentially millions more antibodies than the company had taught how to produce. Although a jury sided with the patentee Amgen, the district court and the Federal Circuit agreed with Sanofi’s contention, ruling that Amgen did not meet the enablement requirement as a matter of law.
The enablement requirement is a crucial aspect of the patent “bargain”: an inventor is granted limited protection from competition in exchange for publicly disclosing their new technology. The Supreme Court, in its decision, referenced previous cases such as Morse, Incandescent Lamp, and Holland Furniture, as establishing the requirement that if a patent claims an entire class or genus of processes, machines, or compositions of matter, the specification must enable a person skilled in the field to make and use the entire class. In simpler terms, it follows the elementary school principle: If you bring cookies to share, bring enough for everyone.
If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims.
The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405 (1908) (“[T]he claims measure the invention.”).
Amgen v. Sanofi.
In this case, Amgen sought exclusivity for the entire class of functional antibodies, not just the 26 antibodies expressly disclosed. Although Amgen also provided a “roadmap” for discovering more antibodies, the court found that those approaches were insufficient “research assignments” rather than a clear process for creating the additional antibodies. The Supreme Court ruled that these disclosures did not fulfill the enablement requirement as per the Patent Act, as they simply described Amgen’s trial-and-error method without providing sufficient information for skilled scientists to make the entire class of claimed antibodies.
The Supreme Court did agree with Amgen that functional/genus claims should not be held to a stricter standard of enablement. In other words, there is “one statutory enablement standard.” Nonetheless, the general principle remains that broader claims necessitate more enablement, and all claims must be enabled to their “full scope.”
The outcome of the Amgen v. Sanofi case, while significant, may not come as a surprise to those familiar with the evolution of patent law. In recent years, there has been a growing emphasis on promoting innovation and competition by limiting the scope of patent monopolies. This approach recognizes that patents should strike a balance between incentivizing inventors to disclose their inventions and ensuring that the public can freely build upon existing knowledge. Rather than granting broad and far-reaching patent rights, the trend has been towards encouraging more focused and narrowly tailored claims. This shift reflects a recognition that patents are more palatable when they offer bite-sized protection rather than providing a singular and overpowering monopoly. The ruling in the Amgen v. Sanofi case aligns with this approach, reinforcing the notion that patents should enable the creation and use of the claimed inventions while still allowing for competition and further advancements in the field.
This week, the Federal Circuit disclosed further documents from a special committee established to evaluate the potential removal of Judge Pauline Newman from active duty due to a suspected mental or physical disability that could affect her judicial capabilities. The order, dated May 16, 2023, gives a more comprehensive discussion on concerns about Judge Newman’s performance, including signs of memory issues or confusion and diminished productivity. The document also outlines an investigation involving requested medical assessments and records, which Judge Newman has declined to provide.
The committee, formed on March 24, 2023, and comprising of Chief Judge Moore, Judge Prost, and Judge Taranto, is tasked to scrutinize the complaint, deliver their findings, and propose recommendations. Successive orders on April 7, April 17, and May 3, 2023, commanded Judge Newman to undertake a neurological evaluation and neuropsychological testing, backed unanimously by the council members based on noticeable changes in her mental sharpness. Judge Newman opposed the mandated examinations, arguing that she should have the right to choose the medical professionals conducting them and that these examinations should have boundaries.
The May 16 order reiterates the need for these examinations in light of substantial evidence suggesting a possible disability that might inhibit Judge Newman’s judicial functions. The document then elaborates on the concerns expressed by court employees about Judge Newman’s competence. Reports from employees from various departments, including the Clerk’s Office, IT, HR, and Judge Newman’s chambers, highlight issues like memory lapses, confusion, paranoia, and inability to execute simple tasks. Notably, it details frequent accusations from Judge Newman about her email and computer being hacked, and her phones being bugged, as well as difficulty with everyday tasks such as logging into the court system, misplacing court documents, and forgetting information. The Judge has also shown confusion regarding court rules and struggled with mandatory security awareness training. These issues suggest significant cognitive impairment, according to the order, warranting a medical examination.
The document further mentions that “two out of five members of Judge Newman’s staff have recently resigned and have requested to have no further contact with Judge Newman.” It adds that “Judge Newman threatened to have a staff member arrested and removed from the building,” and another staff member “asserts her Fifth Amendment right to remain silent to avoid self-incrimination when asked about her role and responsibilities in the chambers, based on her lawyer’s advice.”
In the US, registered patent practitioners are required to have a science or engineering background. Over the past few years, the US Patent and Trademark Office (USPTO) has been refining the qualification process. Nearly all incoming patent attorneys qualify by either (A) possessing a specific degree (such as mechanical engineering) or (B) accumulating a sufficient number of university science or engineering credits. These two methods are referred to as Category A and Category B in the General Requirements Bulletin for Admission to the Examination for Registration to Practice in Patent Cases (GRB).
The USPTO previously simplified the path for potential registrants by including typical Category B degrees under Category A. The Office clarified that “incorporating these Category B degrees into Category A will enhance operational efficiency and expedite the application process for prospective patent practitioners.” Additionally, the Office began accepting advanced degrees under Category A.
Recently, the Office has taken several more steps:
1. Instituting a three-year review process to consider adding more qualifying degrees.
2. Abolishing the rule that computer science degrees can only qualify for Category A if they are from a program accredited by the Computer Science Accreditation Commission of the Computing Sciences Accreditation Board, or by the Computing Accreditation Commission of ABET.
These minor amendments will alleviate the pressure on patent applicants and reduce the workload of the Office of Enrollment and Discipline (OED).
The updated rules also clarify the conditions for non-US citizens seeking to register as patent attorneys. According to the regulations, non-citizens living outside the US are ineligible to register as US practitioners, with the exception of Canadians under 37 CFR 11.6(c). However, a non-citizen residing in the US can gain “limited recognition to practice” before the USPTO in patent matters, provided they can demonstrate that such activities are consistent with their immigration status. The USPTO will assess (1) the applicant’s permission to reside in the United States, and (2) the applicant’s authorization to work or receive training in the United States.
These revised regulations are effective immediately.
The United States Patent and Trademark Office has proposed a rule to create a separate design patent practitioner bar. The USPTO is publishing this proposal in the Federal Register on May 16, 2023 (link below to the prepub).
As it stands today, there is a single patent bar that applies to those practicing in patent matters before the USPTO, covering utility, plant, and design patents. And, even though design patents cover ornamentally, the current rules require that the design patent practitioner be an engineer or scientist.
The proposed rule aims to establish an additional separate bar for those who only specialize in design patents, ensuring that they have the necessary qualifications, while opening the door to non-engineers. The proposal appears to not affect those already registered to practice. Existing patent practitioners will continue to practice as before, and new applicants who meet the current criteria, including passing the existing registration exam, will also be permitted to practice in all patent matters, including design patent matters.
In Fall 2022, the USPTO asked for comments on proposals in this direction and received mostly positive comments. Stakeholders acknowledged that the move would encourage broader participation in the patent system.
The proposal would still have a ‘technical’ requirement, typically a degree in one of the following: industrial design, product design, architecture, applied arts, graphic design, fine/studio arts, or art teacher education. The degree requirements here align with the current hiring practices of the USPTO for design patent examiners. In addition to the degree requirements, applicants would have to meet the other requirements to register for the bar, including taking and passing the current registration examination and passing a moral character evaluation.
The USPTO will accept comments on the proposed rulemaking through August 14, 2023 via the regulations.gov portal.
In spite of robust amicus backing, including from the US Solicitor General, the Supreme Court has declined to review two pending patent-eligibility petitions: Interactive Wearables v. Polar and Tropp v. Travel Sentry. These cases contended that the Alice/Mayo framework produced (1) instability and unpredictability in the law; (2) facilitated non-evidence based judgments by district courts; and (3) prohibited patenting of subject matter that has traditionally been eligible for patents.
In my perspective, these cases wouldn’t have led to pro-patentee opinions from the Supreme Court as the inventions involved were not firmly rooted in technology. Rather, the court would likely have regarded the appellate cases as correctly denying eligibility.
The case of utmost importance still awaiting judgment, in my opinion, is CareDx Inc. v. Natera, Inc. CareDx is centered around the eligibility of an important diagnostic method for early detection of transplant organ failure. In this instance, the patent holder (Stanford University) solved a significant, longstanding problem that others had been unable to resolve. However, the lower courts determined that the patent claims were improperly directed towards a law of nature. Another petition pending before the Court is the eligibility appeal in Avery Dennison Corp. v. ADASA Inc. In the Avery Dennison case, the patent for RFID unique-ID encoding was deemed eligible and therefore valid on debatable grounds. The patent challenger has petitioned the Supreme Court, arguing that the lower courts are unduly narrowing their eligibility assessment.
A further petition, Killian v. Vidal, was reportedly filed in April but has yet to appear on the Supreme Court docket. Killian’s patent application proposes a computerized algorithm for detecting “overlooked eligibility for social security disability insurance.” The petition contends that the uncertainty created by the courts, along with the non-statutory eligibility exceptions, amount to violations of the Administrative Procedure Act (APA) and Due Process. Furthermore, the petition asserts that these judge-made exceptions “overstep the constitutional authority of the courts.” This petition has a minimal likelihood of being granted.
= = = =
The court also denied certiorari in the skinny-label FDA-Patent case of Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC.
Guest Post byPaul R. Gugliuzza, Professor of Law, Temple University Beasley School of Law
The judicial disability proceedings instituted against Federal Circuit Judge Pauline Newman have now spilled into litigation. As Dennis reported yesterday, Judge Newman filed a complaint in D.C. federal district court seeking, among other things, to enjoin and terminate the proceedings.
Judge Newman’s complaint contains previously unreported details about the events giving rise to the disability proceedings against her. For instance, the complaint discloses an allegation, which was previously redacted from an order written by Chief Judge Moore in the disability proceedings, that, in the summer of 2021, Judge Newman had a heart attack and underwent coronary stent surgery.
Judge Newman’s complaint responds to that allegation by stating that “[d]uring the period (June 2021 through September 2021) when Chief Judge Moore claims that Judge Newman suffered a heart attack, Judge Newman sat on ten panels and issued at least eight (including majority, concurring, and dissenting) opinions.” Chief Judge Moore’s order, for its part, noted that Judge Newman wrote many fewer majority opinions than her colleagues over the past few years.
This dispute over Judge Newman’s ability to perform her judicial duties is an unfortunate tarnish on Judge Newman’s reputation and on the image of the Federal Circuit. And, because many of the relevant events occurred behind closed doors, we might never know for sure what’s been happening.
Is Judge Newman slowing down at age 95? Quite possibly. But is she “unable to discharge all the duties of office”—the standard set by law for instituting disability proceedings?
For some insight into Judge Newman’s workload as compared to her colleagues, I used Jason Rantanen’s Compendium of Federal Circuit decisions to collect and analyze data on the number of opinions written by individual Federal Circuit judges from June 2021 (the time of Judge Newman’s alleged heart attack) through the end of 2022. Those numbers tell a complicated story.
First off, Judge Newman’s assertion in her complaint that she wrote eight opinions from June 2021 through September 2021 is pretty much accurate. Over that time period, Judge Newman wrote one majority opinion (in a veterans case) and six dissenting opinions (either partial or full). In the eighth and final case that I was able to find, Judge Newman concurred in the result but didn’t write an opinion.
How does Judge Newman’s rate of opinion writing compare to her colleagues? The table below reports the number of opinions (precedential or not) written by each Federal Circuit judge who was in active service for the entire time period of June 1, 2021 through December 31, 2022—ten judges in total.
Opinions by Federal Circuit Judges (June 1, 2021 through December 31, 2022)
As the table makes clear, Judge Newman is an outlier, having written only nine majority opinions over that 19-month period. The judge with the next lowest number of majority opinions, Judge Chen, wrote three times as many as Judge Newman. In a group of ten active court of appeals judges, we would expect that, on average, each judge would write roughly 10% of the majority opinions. Yet Judge Newman wrote barely 2% (9 of 387).
Looking at concurring and dissenting opinions complicates things though. From June 2021 through the end of 2022, Judge Newman wrote 23 of those separate opinions. (And she concurred or dissented without opinion in four additional cases.) The two judges with the next most separate opinions, Judges Reyna and Dyk, wrote roughly half as many (13 and 11, respectively).
Overall, then, Judge Newman wrote 32 opinions from the time of her supposed heart attack through the end of 2022. That’s on the low side for an active Federal Circuit judge, but it’s worth noting that Judge Chen actually wrote fewer total opinions (30) over that same period.
Is a judge who writes, on average, more than one dissent or concurrence a month “unable” to discharge her duties? Arguably not. But, then again, there are underlying questions about Judge Newman’s physical and mental health that we can’t possibly know the answers to at this point.
And nothing is helped by the often-salacious framing of these disability proceedings as, essentially, a personal dispute between a famously headstrong—and female—Chief Judge quarreling with another female judge who, regardless of recent events, is indisputably a titan of the patent bar.
Rather, Judge Moore is acting in her official capacity as chief judge of a federal court of appeals and is proceeding in accordance with the framework set by statute and by the rules governing judicial disability proceedings. Judge Newman, for her part, is contesting both the process and merits of those proceedings, as she has every right to do. It’s not a judicial “cat fight.” It’s a legal dispute among judges—including other judges on the Federal Circuit—who genuinely disagree about what’s best for the court and the litigants who appear before it.
Turning back to the opinion numbers, the nub the conflict might be Judge Newman’s propensity to dissent. Each one of her 23 separate opinions reported on the table above dissented, at least in part. Because a dissenting judge, by definition, can’t write the majority opinion, a judge who dissents a lot creates a lot more work for her colleagues. And judges are, in the end, just people. A judge who does less work on majority opinions and who regularly refuses to compromise is unlikely to win many friends. Nor is a judge who constantly dissents likely to respond well to colleagues who suggest she take senior status or retire. Even if none of the Federal Circuit’s judges say so, frustration with Judge Newman as the court’s “great dissenter” is probably at least part of the reason for this sad saga.
I have often written about situations where Judge Pauline Newman’s position is opposed to those taken by other judges on the Federal Circuit. But today we go a step further, by actually filing a lawsuit: Newman v. Moore. The defendant is Chief Judge Kimberly Moore along with Judge Sharon Prost, Judge Richard Taranto, and the Judicial Council of the Federal Circuit.
The lawsuit stems from the move by the Chief along with other members of the court to forcibly remove Judge Newman from office pursuant to the Judicial Conduct and Disability Act of 1980. Of course, the Constitution indicates that impeachment is the process for removing a Federal Judge, not some internal process, even if authorized by Congress.
The lawsuit asks for the Act to be held unconstitutional; any ongoing proceedings held unconstitutional; declare any secrecy order on Judge Newman to be a violation of her rights; etc. The complaint also reveals some previously unreported allegations.
The USPTO has proposed a major set of patent fee revisions. One purpose of the new fees is to raise revenue. It is also clear that the proposal is designed to shift patent applicant behavior along certain fronts. You can read more at the following links. Note, that the PPAC will be holding a public hearing Thursday, May 18, 2023, from 1-3 p.m. ET.
I submitted a brief comment arguing that before any fee shifting occurs, it is essential to conduct an economic analysis to forecast the impact on USPTO revenue and on innovator behavior. In the commentary, I outline four general categories of fees, including (1) fees designed to raise money for the USPTO, (2) fees that create a costly screen, (3) fees that shift behavior without substantially shifting rights or raising overall costs, and (4) fees that discourage certain behaviors that result in a loss of rights for users. Each of these categories has potential major impacts, but categories 2 and 4 raise special concerns.
In the commentary, I identify eight specific proposed fee changes that require special attention by the USPTO chief economist or other economic experts. These include new and increased fees for AIA Trial filings, new large costs for terminal disclaimers, and substantial increases in fees for additional claims, among others.
In Bonito Boats, Inc. v. Thunder Craft Boats, Inc., the Supreme Court addressed the issue of state laws that provide additional patent-like rights. The Court held that a Florida law prohibiting the use of a direct molding process to duplicate unpatented boat hulls was preempted by federal patent law. The Court reasoned that the Florida law conflicted with the “carefully crafted” goals of the federal patent system.
The USPTO and Courts have made clear that AI-created inventions are outside of the scope of US patent law. I think the answer is probably quite clear, but do folks think that the Bonito Boats approach would also preempt the states from from creating an exclusive-right award for AI-generated innovations?
The UCANN vs. Pure Hemp patent case has come to a close with the Federal Circuit affirming the district court’s decision to deny attorney fees to Pure Hemp. The original infringement lawsuit was filed in 2018, with UCANN suing Pure Hemp for infringing US Patent No. 9,730,911, covering various high concentration cannabis and CBD extract formulations. During the litigation, UCANN filed for bankruptcy, causing the case to be stayed, and eventually, the parties stipulated to a dismissal of the infringement claims with prejudice. However, the stipulated dismissal did not include any discussion of attorney fees — leading to the current appeal.
Following the dismissal, Pure Hemp moved for attorney fees and sanctions, arguing that UCANN’s counsel committed inequitable conduct during patent prosecution and that UCANN’s litigation counsel had a conflict of interest. The district court sided with UCANN and denied attorney fees, stating (1) that Pure Hemp was not the prevailing party and (2) that Pure Hemp did not prove that the case was exceptional. The Federal Circuit has now affirmed the decision, finding that the district court did not abuse its discretion in finding the case unexceptional. Although district court the district court erred in not finding Pure Hemp to be the prevailing party, the error was harmless.
The pace of technological advancement never ceases to amaze me, and it seems like even science fiction is struggling to keep up with reality. In recent months, we’ve witnessed some truly remarkable breakthroughs in the field of artificial intelligence (AI), and this latest development is right up there.
Researchers have used GPT-style machine learning architecture to decode human thoughts by analyzing their functional MRI (fMRI) brain scans. That’s right – we’re talking mind reading. The AI was initially trained trained by exposing participants to 16 hours of narrative stories while recording their brain activity. And, once trained, the AI was able to accurately describe the content of their thoughts. Of some interest, the AI was better at identifying concepts and meaning rather than the actual words at issue.
While this technology has the potential to revolutionize communication for individuals with disabilities or neurological conditions, it also raises some privacy concerns that could involve both reading thoughts and writing them.
I imagine that all this wouldn’t require a fMRI technology and instead could rely upon much smaller safe-for-home equipment such as Functional near-infrared spectroscopy (fNIRS) devices shown in the image above or made by Artinis.
A key for me here is that this is potentially moving toward an API for the human mind and body. For those outside the software world, an API (Application Programming Interface) is a set of protocols, tools, and standards that allow different computer applications to communicate with each other. APIs provide a standardized way for software components to interact. An API for the human mind and body would create an interface that allows software systems to access and interact with the brain or and other body parts. Over the past several years, folks have been making huge advances with brain/body connection, and I’m excited about where we are headed in this expanded mind approach.
A few days ago I wrote an essay about the ongoing economic war between the leaders of the US and those of China, with a focus on the impact US attorneys representing Chinese clients. For the article, I used an AI tool to create some art for my publication. The image above shows the resulting four images. I chose the bottom right and had the AI enhance the image for publication by pushing a single button. I then did a cut and paste before publishing.
Although I didn’t contribute any of the expression seen in the work, after these actions and then publishing it, I actually feel some gut level of ownership. And, that I might be upset if someone else used _my_ image without permission.
My questions for you:
Do I deserve to “own” this image?
Should I be able to claim authorship?
Should I disclose my AI creation methodology when I use the image in published works?
The recently filed petition for certiorari in CareDx and Stanford University v. Eurofins Viracor, Inc. (Supreme Court 2023) offers an opportunity to examine the patent eligibility doctrine in the context of an important health diagnostics innovation. The inventions at issue relate to early detection of organ transplant failure, which obviously hold significant potential to save lives and reduce reliance on invasive exploratory surgical procedures. The detection method involves identifying DNA fragments from the transplant within the bloodstream, a challenge that had stumped scientists for over a decade. Although various scientists had proposed mechanisms for using this information, the evidence shows more than a decade of failed ideas, and at least one article reported that the process is “difficult and impractical.” The breakthrough came when Stanford researchers successfully applied high-throughput multiplex sequencing (“shotgun sequencing”) to detect single nucleotide polymorphisms (SNPs) unique to donor organs. Of potential importance, the Stanford researchers did not create these new sequencing techniques, but they were the first to take advantage of them in this particular context and, as the claim language below shows, the scientists focuses on creating thresholds as part of a method that particularly work in this situation.
Three patents are central to this case: U.S. Patent Nos. 8,703,652, 9,845,497, and 10,329,607. Claim 1 of the ‘607 patent exemplifies the claimed method, which includes the following steps:
Providing a plasma sample from the recipient;
extracting cell-free DNA from the sample;
performing “selective amplification” of target DNA sequences, wherein that amplification “amplifies a plurality of genomic regions comprising at least 1,000 [SNPs]” using PCR;
performing “high throughput sequencing” comprising a “sequencing-by-synthesis reaction” with an error rate of less than 1.5%;
providing sequences comprising “at least 1,000 [SNPs]”; and
quantifying the proportion of donor-derived DNA, using distinguishing biomarkers drawn from those at least 1,000 SNPs, and wherein the donor’s cell-free DNA comprises at least 0.03% of the total in the sample.
The Infringement Lawsuit: The Delaware District Court initially denied defendants’ motions to dismiss and for summary judgment of ineligibility. However, Chief Judge Connolly later reconsidered the summary judgment motion and ultimately ruled that the claims were ineligible under the two-step analysis set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). The Federal Circuit affirmed this decision.
The petition to the Supreme Court raises the following simple question: Is a new and useful method for measuring a natural phenomenon, which improves upon prior methods for measuring the same phenomenon, eligible for patent protection under Section 101? The petition emphasizes the importance of this case compared to Tropp and Interactive Wearables, and it underscores the need for the Supreme Court to review its application of eligibility exceptions to medical diagnostics.
This case has potentially significant implications for US patent law doctrine as well as potential impact on investment in medical diagnostics. We’ll be following the case closely and talking more about its potential effects.
On May 1, the U.S. Supreme Court revealed its decisions from the April 28 conference. Among the three patent cases considered, the court denied certiorari for the pro se case of Wakefield v. Blackboard, while holding over the other two for reconsideration at a later conference. This development increases the likelihood of these two cases being heard by the court, although a grant of certiorari has not yet been announced.
by Dennis Crouch
