Category: Patent

by Dennis Crouch

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.

Continue reading Connect & Collaborate: Unpacking the NAPP 2023 Annual Meeting & Conference at Patently-O.

by Dennis Crouch

“The more one claims, the more one must enable.”

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.

Continue reading Shaping the Future of Patent Law: The Amgen v. Sanofi Decision and Bite-Sized Monopolies at Patently-O.

by Dennis Crouch

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.

Continue reading Assessing Judicial Fitness: Judge Newman’s Alleged Cognitive Decline at Patently-O.

by Dennis Crouch

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.

Continue reading Streamlining the Qualification Process: Key Changes to the USPTO Patent Practitioner Registration at Patently-O.

by Dennis Crouch

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.

Continue reading Streamlining the Qualification Process: Key Changes to the USPTO Patent Practitioner Registration at Patently-O.

by Dennis Crouch

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.

Continue reading A New Horizon: Design Patent Practitioner Bar Proposed by USPTO at Patently-O.

by Dennis Crouch

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.

Continue reading A New Horizon: Design Patent Practitioner Bar Proposed by USPTO at Patently-O.

by Dennis Crouch

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.

Continue reading Certiorari Denied in Eligibility Cases at Patently-O.

Guest Post by Paul 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.

Continue reading Judicial Disability and the “Great Dissenter” at Patently-O.

By Chris Holman

Sanofi-Aventis Deutschland GMBH v. Mylan Pharms Inc., 2023 WL 3311549, — F.4th — (Fed. Cir. May 9, 2023).

The “analogous arts” test is used in patent law to determine whether a particular reference is relevant for the purposes of an obviousness analysis. Under this two prong test, a reference is relevant if it is from the same field of endeavor as the invention at issue, or if it is reasonably pertinent to the problem the invention is trying to solve.  In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)

In its 2007 KSR v. Teleflex decision, the Supreme Court ruled that the obviousness analysis should be more flexible and not confined to rigid rules or tests. Rather, KSR emphasized an “expansive and flexible approach” to obviousness.  While KSR did not directly address the analogous arts test, it could be interpreted as calling for a more flexible approach allowing courts and the PTO more leeway to consider prior art from a broader range of sources as being “analogous” or “reasonably pertinent,” which in principle should make it easier for challengers to invalidate patents.

Continue reading Petitioner’s Failure to Argue that Prior Art was Analogous to Challenged Patent Results in Reversal of IPR Decision at Patently-O.