All posts by Dennis Crouch

About Dennis Crouch

Law Professor at the University of Missouri School of Law.

Shaping the Future of Patent Law: The Amgen v. Sanofi Decision and Bite-Sized Monopolies

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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. 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.

Assessing Judicial Fitness: Judge Newman’s Alleged Cognitive Decline

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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. 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.”

Streamlining the Qualification Process: Key Changes to the USPTO Patent Practitioner Registration

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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.

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.

A New Horizon: Design Patent Practitioner Bar Proposed by USPTO

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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.

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.

Links:

Certiorari Denied in Eligibility Cases

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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. 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.

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The court also denied certiorari in the skinny-label FDA-Patent case of Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC.

Judicial Disability and the “Great Dissenter”

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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. 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.

Judge Newman vs. Chief Judge Moore

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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.

Read it here: NewmanVMooreComplaint

 

Comments on USPTO Proposed Fee Changes

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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.

Read it here: ltr.20230510.FeeShifting

Can States Legislate in the AI Rights Space?

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by Dennis Crouch

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?

Add your vote and remarks here.

Attorney Fees on Undecided Inequitable Conduct Issues

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by Dennis Crouch

United Cannabis Corp (UCANN) vs. Pure Hemp Collective, — F.4th — (Fed. Cir. 2023)

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.

(more…)

An API for the Human Mind

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by Dennis Crouch

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.

Enjoy!

Generative AI and Copyright

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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?

Comment on LinkedIn: https://www.linkedin.com/posts/patentlyo_ai-publishing-art-activity-7059984906633842688-eGgf

 

The Supreme Court and Patent Protection for Medical Diagnostics: A Closer Look at CareDx and Stanford U v. Eurofins

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by Dennis Crouch

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:

  1. Providing a plasma sample from the recipient;
  2. extracting cell-free DNA from the sample;
  3. performing “selective amplification” of target DNA sequences, wherein that amplification “amplifies a plurality of genomic regions comprising at least 1,000 [SNPs]” using PCR;
  4. performing “high throughput sequencing” comprising a “sequencing-by-synthesis reaction” with an error rate of less than 1.5%;
  5. providing sequences comprising “at least 1,000 [SNPs]”; and
  6. 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.

Supreme Court Holds Over Two Patent Cases, Considers Two More on Patent Eligibility

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by Dennis Crouch

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.

The held-over cases include: (more…)

Professional Liability risks of filing in DOCX

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Carl Oppedahl has been focused on the USPTO’s electronic filing and docketing system for several decades. Most recently, he has been calling out the USPTO for “pants-on-fire lies” about the workability of the DOCX standard.  The PTO plans to institute a $400 surcharge for those who fail to use DOCX starting at the end of June 2023.

Oppedahl is presenting two webinars on the topic, focusing on professional liability risks associated with the new process and some tips for reducing the risks:

Professional Liability Risks of Filing in DOCX – for users of Microsoft Word.  Wednesday, May 10, 2023, 10 AM to 11:30 AM Mountain Time.  Executive summary from 10 AM to 10:40 AM, details from 10:40 AM to 11:30 AM.  For more information, or to register, click here.

Professional Liability Risks of Filing in DOCX – for users of non-Microsoft word processors.  Friday, May 12, 2023, 10AM to 11:30 AM Mountain Time.   Executive summary from 10 AM to 10:40 AM, details from 10:40 AM to 11:30 AM.   For more information, or to register, click here.

Establishing Guidelines for Patent Damages: The Garretson v. Clark Case of 1884

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by Dennis Crouch

Calculating damages for patent infringement can be a complex task, particularly when the invention is an improvement to an existing machine or product.  The Supreme Court’s 1884 decision in Garretson v. Clark, 111 U.S. 120, helped establish a rule requiring apportionment in cases involving improvement patents.

The plaintiff, Garretson held two patents covering improved mop heads and sued the defendants for infringement.  The lower court sided with the patentee — finding the claims valid and infringed and also issued an injunction to halt ongoing infringement.  However, the court balked at awarding the requested back-damages for past infringement.

The patentee had offered a simple lost-profit damage calculation.  In particular the court was presented with evidence showing how much profit the patentee made from the sale of each mop, and the patentee asked the court to force the defendant to pay that amount for each of infringing mop.  The circuit court judge Samuel Blatchford appointed NY patent attorney George J. Sicard to conduct an accounting.  Sicard came back with a recommendation of $0 in damages, and Blatchford agreed.

The issue here is that the patent covered an improvement to a mop, but the patentee was seeking damages for the entire profits associated with the mop — not just the value of the improvement.  In his opinion, Blatchford wrote:

The patentee must in every case give evidence tending to separate or apportion the defendant’s profits and the patentee’s damages between the patented feature and the unpatented features, and such evidence must be reliable and tangible, and not conjectural or speculative; or he must show, by equally reliable and satisfactory evidence, that the profits and damages are to be calculated on the whole machine, for the reason that the entire value of the whole machine, as a marketable article, is properly and legally attributable to the patented feature.

Garretson v. Clark, 10 F. Cas. 40, 44 (C.C.N.D.N.Y. 1878).  The plaintiff has the burden of proving damages, but its theory of damages utterly failed. And, no other damages evidence was presented. The effective result was no damages.

At the time of the decision, Blatchfort was a circuit court judge. In 1882, he was nominated by President Chester Arthur to the U.S. Supreme Court.  Because of the long backlog at the time, Blatchfort reached the court before the case was heard (even though it was directly appealed).  The Supreme Court finally got around to hearing the appeal in 1886 and affirmed in an opinion by Justice Field.

The high court quoted Blatfort’s decision as I have done above and  also remarked that for improvement patents, “the patentee must show in what particulars his improvement has added to the usefulness of the machine or contrivance. He must separate its results distinctly from those of the other parts, so that the benefits derived from it may be distinctly seen and appreciated.” Garretson v. Clark, 111 U.S. 120 (1884).

The decision helped establish a clear rule for patentees to follow when claiming damages for improvements in existing machines or contrivances. It emphasized the presentation reliable and tangible evidence to apportion profits and damages between patented and unpatented features or evidence to demonstrate that the entire value of the product is attributable to the patented feature.

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An interesting aside from this case is that the defendant – Charles B. Clark – is also co-inventor of one of the two asserted patents.  Clark had transferred his rights to a third party, and Garretson bought them up.  The case involves sales of 100,000+ mops.

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Note here that this case was brought in equity rather than at law and so that raises a major difference between current cases, and we had different statutory language under the 1870 Act.  A lot of our 1800s patent cases have quirks that leave them not susceptible to direct application to today’s cases.  Still, I be but they still provide some amount of foundational guidance and gives a chance to observe the evolution of the legal principles we know today.

Importance of Due Diligence for Patent Practitioners and the US/China Economic War

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by Dennis Crouch

37 C.F.R. § 11.18(b) imposes crucial responsibilities on patent applicants, attorneys, and agents. Documents submitted to the USPTO implicitly certify that:

  1. Statements made are true or are are believed to be true (based upon information and belief) and do not include any attempt to conceal a material fact; and
  2. That a reasonable inquiry was conducted to confirm that: (i) statements have no improper purposes, (ii) legal contentions are supported by existing law or valid arguments for change, (iii) allegations and factual contentions have or are likely to have evidentiary support, and (iv) denials of factual contentions are based on evidence or a reasonable lack of information or belief.

Recent USPTO disciplinary cases underscore the seriousness of these obligations. Examples include filing a micro entity status request without proper investigation and submitting an information disclosure statement (IDS) by a non-practitioner without practitioner review. Rubber stamping is not permitted.

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Functional Claims: Morse, Halliburton & Amgen

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by Dennis Crouch

In the patent context, functional limitations describe inventions in terms of their function or intended use, rather than their specific structure or components. Such claims have been subject to much debate and litigation throughout the history of the US patent system. Notable Supreme Court cases like O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1854) and Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946) significantly impacted patent practice and the balance between functional and structural claim drafting.

The pending Supreme Court case of Amgen Inc. v. Sanofi, No. 21-757 (2023) is another example, with the potential to further shift the landscape regarding functional claim limitations. The title of my essay on the case following oral arguments, “Bye Bye Functional Claims,” hints at my outlook. Although the patentee focused on other issues in its briefing, the Justices repeatedly questioned the permissibility of broad functional claim limitations.

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Patent Law Primer: A Newsletter Series on Key Patent Law Topics

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I am happy to announce the launch of my newsletter series, “Patent Law Primer: A Short Introduction to Key Issues in Patent Law,” currently distributed through LinkedIn. This series is designed for a broader audience, making it accessible for anyone interested in the subject, not just patent attorneys.

Each essay delves into legal and practical aspects of various patent law topics while weaving in stories of notable court cases and patent disputes, in an attempt to provide readers with more memorable context.

I have already published the first three essays in the series:

  1. When to File a Patent Application
  2. A Primer on Obviousness
  3. Patent Claim Construction

Over the next year or so, I plan to explore an extensive list of about 50 topics. I welcome your thoughts and suggestions on this project, as well as any specific areas of interest you’d like me to cover in future essays.  Your input will help make this newsletter series a useful and engaging resource.

— Dennis

Guidance on Patenting Inventions with AI Contributions

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The following are my remarks given on April 25, 2023 to the USPTO as part of their AI listening session:

by Dennis Crouch

Members of the USPTO, and fellow participants of this AI Listening Session, thank you for inviting me here today and for taking time to consider these important issues.  I want to also thank the prior speakers who have done a great job laying out many of the issues.  I am also happy to work with any of you to help figure this out and reach a workable system that truly encourages innovation.

My name is Dennis Crouch, and I am a law professor at Mizzou and author of Patently-O. It is my privilege to discuss the role of generative AI in the realm of intellectual property and the need for clear guidance from the USPTO.

As artificial intelligence progresses at an unprecedented pace, numerous cases have emerged where generative AI has played a crucial role in conceiving an invention. In certain instances, if the AI were human, it would be rightfully recognized as at least a joint inventor. This raises the question of whether it is appropriate to designate the human, who contributed to only a part of the invention and collaborated with the AI, as the sole inventor. This is particularly concerning in cases where the AI introduced concepts that the human had not conceived or even considered. Generative AI differs from traditional tools in that its responses are unpredictable and it produces results akin to those of a human inventor.

I would like to draw attention to a striking similarity between generative AI and biological models, particularly in the context of the pending Supreme Court case of Amgen v. Sanofi. In this case, researchers patented a genus of monoclonal antibodies, but the antibodies’ amino acid sequences were not designed by humans. Instead, a genetically modified humanized mouse generated the antibodies in response to a specific antigen. This scenario closely mirrors the role of generative AI in the invention process.

The parallel between the genetically modified humanized mouse and generative AI becomes apparent when we examine the prompt given to the mouse in the form of a PCSK9 injection and the subsequent response: antibodies collected from the mouse’s spleen. This analogy can be applied to generative AI, with a human providing the initial input or prompt, and the AI system generating an inventive output.

One key issue is the uncertainty patent attorneys face regarding the proper course of action. Innovators are seeking to protect their valuable inventions, but the lack of clear guidance creates potential ethical dilemmas for patent attorneys. I recently published an article on Patently-O titled “AI Inventor and the Ethics Trap for US Patent Attorneys,” highlighting this concern.

I believe the USPTO should promptly offer guidance, stating that patent applications may appropriately list the human contributor to the conception as the sole inventor, even in situations where an AI or other tool provided key elements of the discovery.

The US Copyright Office has taken steps to deny registration of AI-created works. It is essential for the USPTO to avoid the current pitfalls of the US Copyright Office in addressing AI-related issues.  Ideally, US intellectual property policymakers would consider all aspects of IP—patent, trade secret, and copyright in our situation here—as a unified whole. This might present an opportunity to contemplate the establishment of a US Intellectual Property Office that merges the PTO and Copyright Office, while also providing some authority to regulate trade secrecy.

As several speakers have noted, generative AI is expected to reduce the cost of inventing, which is a tremendous benefit. As Profs Levine and Feldman explained, AI has different incentives than human inventors and lacks the fundamental humanity that our inventorship laws respect.  Still, a valuable technological improvement by an AI (such as a new medical treatment) is something that we want to encourage.

For inventions without direct human contribution, it is timely to consider a special rights category for computer-generated inventions. This unique exclusivity could feature a reduced term and additional requirements to ensure clarity and patentability, such as pre-screening, limited claims, definitions, and the incorporation of born-digital aspects of the documentation.

In conclusion, it is imperative for the USPTO to provide guidance on how to handle generative AI’s role in the invention process – distinguishing between situations where a human inventor exists and those with in no or insufficient human originality.