Utah, West Virginia, and Wyoming Enact Laws Defining Male and Female
Utah, West Virginia, and Wyoming recently passed laws aligning with recent executive orders issued by President Donald Trump defining sex as binary and immutable.
Quick Hits
Utah, West Virginia, and Wyoming lawmakers recently enacted state laws recognizing only two genders, male and female.
The state legislators acted after President Donald Trump issued an executive order establishing that the federal government’s new policy is to recognize only two sexes, male and female, despite contravening federal law.
The three states restrict transgender and nonbinary individuals from using public school bathrooms and locker rooms that align with their gender identity.
Utah, West Virginia, and Wyoming joined Iowa and other states in passing state laws redefining gender as binary (e.g., male and female only) and immutable, thus attempting to reject governing Supreme Court of the United States case law recognizing gender identity as a protected characteristic under Title VII of the Civil Rights Act of 1964.
The Supreme Court ruled in Bostock v. Clayton County, Georgia that the firing of an employee because of the employee’s sexual orientation or gender identity constituted unlawful sex discrimination under Title VII. Various courts have since applied Bostock to prohibit discrimination on the basis of gender identity by protecting rights to use bathrooms corresponding to gender identity and to use pronouns reflecting one’s gender identity. Despite the fact Bostock remains good law, on January 20, 2025, President Trump signed an executive order to define sex as binary and immutable. The laws in Utah, West Virginia, and Wyoming track the executive order.
Utah Law
On January 30, 2025, Utah Governor Spencer Cox signed a law requiring transgender and nonbinary people to use bathrooms, locker rooms, and showers that correspond with their sex assigned at birth. The new law applies only to government buildings and public schools, but took effect immediately.
The new law defines female as “an individual whose biological reproductive system is of the general type that functions in a way that could produce ova.” It defines male as “an individual whose biological reproductive system is of the general type that functions to fertilize the ova of a female.”
As of September 1, 2024, Utah’s legal code defines sex as being “male or female, at birth, according to distinct reproductive roles as manifested by sex and reproductive organ anatomy; chromosomal makeup; and endogenous hormone profiles.”
West Virginia Law
On March 18, 2025, West Virginia Governor Patrick Morrisey signed into law a bill establishing only two sexes, male and female, under state law. It defines female as “an individual who naturally has, had, will have through the course of normal development, or would have but for a developmental anomaly, genetic anomaly, or accident, the reproductive system that at some point produces, transports, and utilizes ova for fertilization.” It defines male as “an individual who naturally has, had, will have through the course of normal development, or would have but for a developmental anomaly, genetic anomaly, or accident, the reproductive system that at some point produces, transports, and utilizes sperm for fertilization.” This law will take effect on June 16, 2025.
The law also states there must be a reasonable accommodation, such as a single-occupancy restroom or changing area, for people who are not willing or able to use the facility assigned to their biological sex.
Wyoming Law
On March 5, 2025, the Wyoming legislature passed a bill that defines sex as being male or female at birth. It defines female as “a person who has, had, will have or would have had, but for a congenital anomaly or intentional or unintentional disruption, the reproductive system that at some point produces, transports and utilizes eggs for fertilization.” It defines male as “a person who has, had, will have or would have had, but for a congenital anomaly or intentional or unintentional disruption, the reproductive system that at some point produces, transports and utilizes sperm for fertilization.”
This bill became law on March 14, 2025, without the governor’s signature. It took effect immediately.
On March 3, 2025, Governor Mark Gordon signed a different bill into law that requires public school students to use bathrooms and locker rooms that align with their sex assigned at birth.
That law took effect immediately.
Next Steps
Amid the changes in federal guidance and state law, Bostock remains good law and prohibits harassment and discrimination based on sexual orientation and gender identity. Further, the U.S. Equal Employment Opportunity Commission’s (EEOC) sex harassment guidelines voted on by the EEOC and issued in April 2024 remains active guidance. The EEOC’s acting chair, Andrea Lucas, has stated she wants to rescind all or part of the earlier guidance related to gender identity, in particular bathroom and pronoun usage, once a quorum exists as the EEOC.
Employers in public schools and government buildings in Utah, West Virginia, and Wyoming may wish to review their policies and practices to ensure employees have safe access to single-sex facilities, as required under the Occupational Health and Safety Act’s general duty clause, and carefully evaluate compliance with all applicable, federal, state, and local laws regarding access to bathrooms, locker rooms, dorms, and showers. The restrictions passed in the states do not apply to private employers in private buildings.
Federal Circuit: Machine Learning Patents Ineligible in Recentive Analytics, Inc. v. Fox Corp.
Go-To Guide:
The Federal Circuit ruled, in a case of first impression, that the machine learning patents at issue were ineligible under 35 U.S.C. § 101.
In its precedential decision, the court held that claims that merely apply “established methods of machine learning” to “new data environments” are ineligible for protection.
The court emphasized that iterative training and dynamic adjustments are inherent to the nature of machine learning and do not constitute an inventive concept.
The decision underscores the importance of disclosing specific implementations or improvements to machine learning processes in patent applications.
In a precedential decision addressing the intersection of machine learning and patent law, the Federal Circuit affirmed the district court’s dismissal of Recentive Analytics, Inc.’s patent infringement claims against Fox Corp. and its affiliates. The court held that Recentive’s patents merely applied generic machine learning techniques to the fields of event scheduling and network map creation, and thus were directed to abstract ideas that lacked an inventive concept sufficient to satisfy the requirements of 35 U.S.C. § 101. This decision underscores the challenges of securing patent protection for new applications of established machine learning techniques in various fields.
In a succinct statement of the Federal Circuit’s decision, Judge Dyk, writing for the panel that included Judge Prost and Chief District Judge Goldberg (sitting by designation), stated “[t]his case presents a question of first impression: whether claims that do no more than apply established methods of machine learning to a new data environment are patent eligible. We hold that they are not.”
Recentive Analytics, Inc. is the owner of four patents: U.S. Patent Nos. 10,911,811 (‘811 patent), 10,958,957 (‘957 patent), 11,386,367 (‘367 patent), and 11,537,960 (‘960 patent). These patents fall into two categories: the “Machine Learning Training” patents (the ‘367 and ‘960 patents) and the “Network Map” patents (the ‘811 and ‘957 patents). The Machine Learning Training patents claim methods for dynamically generating optimized schedules for live events using machine learning models, while the Network Map patents claim methods for creating optimized network maps for television broadcasters using similar techniques.
Recentive sued Fox Corp., Fox Broadcasting Company, LLC, and Fox Sports Productions, LLC (collectively, Fox) for infringement of these patents. Fox moved to dismiss the complaint, arguing that the patents were directed to ineligible subject matter under § 101. The district court granted the motion, finding that the patents were directed to abstract ideas and lacked an inventive concept. Recentive appealed to the Federal Circuit.
The Machine Learning Training patents focus on optimizing event schedules using machine learning models. Claim 1 of the ‘367 patent is representative and describes a method involving:
1.
Collecting Data: Receiving event parameters (e.g., venue availability, ticket prices) and target features (e.g., event attendance, revenue).
2.
Training the Model: Iteratively training a machine learning model to identify relationships between the event parameters and target features using historical data.
3.
Generating Output: Producing an optimized schedule for future events based on user-specific inputs.
4.
Updating the Schedule: Dynamically adjusting the schedule in response to real-time changes in data.
The specification emphasizes that the machine learning model can employ “any suitable machine learning technique,” such as neural networks, decision trees, or support vector machines. It also highlights the use of generic computing equipment to implement the claimed methods.
The Network Map patents address creating network maps for broadcasters, which determine the programming displayed on television stations in various geographic markets. Claim 1 of the ‘811 patent is representative and describes a method involving:
1.
Collecting Data: Receiving broadcasting schedules for live events.
2.
Analyzing Data: Generating a network map that optimizes television ratings across multiple events using machine learning techniques.
3.
Updating the Map: Dynamically adjusting the network map in real time based on changes to schedules or criteria.
4.
Using the Map: Determining program broadcasts based on the optimized network map.
Like the Machine Learning Training patents, the Network Map patents discuss the use of generic machine learning techniques and computing equipment.
The lower court applied the two-step framework established in Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), to assess patent eligibility. At step one, the court found that the claims were directed to abstract ideas—producing event schedules and network maps using known mathematical techniques. At step two, the court concluded that the claims lacked an inventive concept, as they merely applied generic machine learning techniques and relied on conventional computing devices. The court also denied Recentive’s request for leave to amend, finding that any amendment would be futile.
The Federal Circuit affirmed the district court’s decision, holding that Recentive’s patents were ineligible under § 101. The court’s analysis focused on both steps of the Alice framework.
At step one, the Federal Circuit examined whether the claims were directed to patent-ineligible abstract ideas. The court emphasized that the focus of the claimed advance over the prior art was the application of generic machine learning techniques to the fields of event scheduling and network map creation. It noted that Recentive had repeatedly conceded that its patents did not claim improvements to machine learning itself but merely applied existing machine learning methods to new environments.
The court observed that the Machine Learning Training patents relied on conventional machine learning techniques, such as neural networks and decision trees, and generic computing equipment. Similarly, the Network Map patents employed generic machine learning methods to optimize television ratings. The court concluded that the claims were directed to abstract ideas because they did not disclose any technological improvement or specific implementation of machine learning.
The Federal Circuit rejected Recentive’s argument that its patents were eligible because they applied machine learning to a new field of use. Citing precedent, the court reiterated that “[a]n abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment.” The court also noted that applying existing technology to a novel database or data environment does not create patent eligibility.
At step two, the Federal Circuit considered whether the claims contained an “inventive concept” sufficient to transform the abstract idea into a patent-eligible application. Recentive argued that its patents introduced an inventive concept by using machine learning to dynamically generate optimized maps and schedules based on real-time data. The court rejected this argument, finding that the claimed methods merely described the abstract idea itself. The court emphasized that iterative training and dynamic adjustments are inherent to the nature of machine learning and do not constitute an inventive concept. It noted that the patents did not disclose any specific method for improving machine learning algorithms or achieving technological advancements. Instead, the claims relied on generic machine learning techniques and computing devices, which are insufficient to satisfy step two of the Alice inquiry.
The Federal Circuit also rejected Recentive’s argument that its patents were eligible because they performed tasks previously undertaken by humans with greater speed and efficiency. The court explained that increased speed and efficiency resulting from the use of computers do not render claims patent eligible unless they involve improved computer techniques.
Takeaways
The Federal Circuit’s decision highlights the court’s thinking on patent eligibility limits as applied to machine learning-based inventions. The court has now clarified that applying generic machine learning techniques to new data environments does not create patent eligibility unless the claims disclose specific technological improvements or inventive concepts. This holding is consistent with the Federal Circuit’s broader § 101 jurisprudence, which has repeatedly emphasized that abstract ideas do not become patent eligible simply by limiting them to a particular field of use or implementing them on generic computing devices. The decision also underscores the importance of disclosing specific implementations or improvements to machine learning processes in patent applications.
At its conclusion, the decision recognizes that “[m]achine learning is a burgeoning and increasingly important field and may lead to patent-eligible improvements in technology” and provides some hope that its decision will be cabined to specific facts by stating “[t]oday, we hold only that patents that do no more than claim the application of generic machine learning to new data environments, without disclosing improvements to the machine learning models to be applied, are patent ineligible under § 101.” It will remain to be seen how lower courts, and the U.S. Patent Office, apply this new decision.
For practitioners, the Recentive decision highlights the need to carefully draft claims that go beyond the mere application of existing machine learning techniques. Patent applicants should focus on demonstrating how their inventions improve machine learning models or achieve technological advancements. Without such disclosures, machine learning-based patents may face significant hurdles under § 101. As machine learning continues to play an increasingly important role in technological innovation, this decision serves as a reminder of the challenges of securing patent protection in this evolving field.
China’s Supreme People’s Court Releases “Status of Judicial Protection of Intellectual Property Rights in Chinese Courts (2024)” – Criminal IP Enforcement Up 24% in 2024
On April 21, 2025, China’s Supreme People’s Court released the “Status of Judicial Protection of Intellectual Property Rights in Chinese Courts (2024)” (中国法院知识产权司法保护状况(2024年)) providing a wealth of data regarding Chinese IP litigation in 2024. Criminal IP enforcement continues to grow in China with Chinese courts receiving 9,120 first-instance criminal cases involving infringement on IP and concluding 9,003 such cases, marking increases of 24.34% and 29.22% compared to 2023, respectively. Overall, Chinese courts received 529,370 IP cases and concluded 543,911 cases, representing a decrease of 2.67% and an increase of 0.001% respectively over 2023.
First Instance Civil IP Cases Received – 2024 vs. 2023
First Instance Criminal IP Cases Received – 2024 vs. 2023
Other statistics released include:
Punitive damages were applied in 460 cases involving seriously malicious infringement, marking a year-on-year(YoY) increase of 44.2%.
Newly received patent cases totaled 44,255, down 1.02% compared to the previous year;
trademark cases numbered 124,918, down 4.95% from the previous year;
copyright cases amounted to 247,149, down 1.8% compared to 2023;
technology contract cases reached 8,320, up 28.16% YoY;
competition-related cases totaled 10,567, up 3.29% YoY; and
other types of civil IP disputes amounted to 14,714, down 16.53% YoY.
Chinese courts accepted 20,849 administrative IP cases of the first instance and 27,745 were concluded, showing increases of 1.29% and 24.19% from 2023, respectively.
newly received patent cases totaled 1,679, down 15.63% YoY;
trademark cases numbered 19,130, up 3.08% YoY;
copyright cases stood at 9, decreasing by 2 cases compared to 2023; and
other types of cases totaled 31, up 29.17% YoY.
Chinese courts received 9,120 first-instance criminal cases involving infringement on IP and concluded 9,003 such cases, marking increases of 24.34% and 29.22% compared to 2023, respectively.
1 criminal case related to patent counterfeiting was newly received, and 2 such cases were concluded;
8,079 were criminal cases involving registered trademark infringement, and 8,017 such cases were concluded, representing YoY increases of 21.78% and 26.11%;
938 were criminal cases involving copyright infringement, with 913 such cases concluded, reflecting YoY increases of 49.6% and 68.14% respectively;
102 other criminal cases were newly filed, while 77 such cases were concluded in the same year, up 39.73% and 7.58% YoY, respectively.
The full text in Chinese and English is available here: 中国法院知识产权司法保护状况（2024).
Supreme Court’s E.M.D. Sales v. Carrera Decision: A Victory for Employers Navigating FLSA Exemptions
A January 15, 2025, U.S. Supreme Court opinion brought welcome news for employers defending claims of worker exempt status misclassification under the Fair Labor Standards Act (FLSA). In the case at issue, E.M.D. Sales, Inc. v. Carrera, the court clarified the applicable standard of proof, ruling that employers need only demonstrate by a “preponderance of the evidence,” the standard used in most civil cases, that an employee qualifies for an FLSA exemption, rather than the higher more stringent “clear and convincing evidence” standard previously applied by the Fourth Circuit Court of Appeals.
Background of the Case
E.M.D. Sales (“E.M.D.”), a food distributor in the Washington, D.C. area, employed sales representatives who managed inventory and took orders at grocery stores. These employees sued the company, alleging violations of the FLSA’s overtime provisions. E.M.D. contended that the sales representatives were exempt from overtime pay as “outside salesmen” under the FLSA. The district court ruled in favor of the employees, finding that E.M.D. failed to prove the exemption by clear and convincing evidence. On appeal, the Fourth Circuit upheld this decision, prompting the company to seek review from the Supreme Court.
Supreme Court’s Ruling
Justice Kavanaugh, writing for the court, emphasized that the less-exacting “preponderance of the evidence” standard (which would only have required E.M.D. to prove that it was more likely than not that the exemption applied) is the default in civil litigation, absent specific statutory or constitutional mandates for a higher burden of proof. The court identified three narrow exceptions where a heightened standard might apply:
Statutory Directive: When Congress explicitly requires a higher standard.
Constitutional Mandate: In certain First Amendment and Due Process cases.
Extraordinary Government Action: Such as denaturalization or expatriation.
Since none of these exceptions applied to the FLSA exemptions, the court concluded that the preponderance standard governs such disputes.
Impact on Employers
This decision marks a pivotal shift in the legal landscape for employers, particularly those operating in the Fourth Circuit, which includes Maryland, Virginia, West Virginia, North Carolina, and South Carolina. Previously, employers in this jurisdiction faced the challenging task of proving FLSA exemptions by clear and convincing evidence — a higher bar than the preponderance standard. With the Supreme Court’s ruling, employers now have a more consistent and manageable standard to meet across all federal circuits.
Employers relying on the FLSA’s “white-collar” exemptions, such as professional, executive, administrative, and outside sales roles, can now classify employees under these exemptions, knowing that the evidentiary threshold makes these classifications more defensible. This clarity can lead to reduced litigation risks and potential cost savings in defending against wage and hour claims.
Considerations for Employers
While the Supreme Court’s decision provides a more favorable framework for employers, it does not grant carte blanche to misclassify employees. Employers must still ensure that job duties and compensation align with the specific criteria outlined in the FLSA for each exemption. Misclassification can lead to significant legal and financial repercussions.
We continue to see a substantial amount of FLSA litigation, so employers should take care to ensure they are properly applying FLSA exemptions to their workforce. This includes reviewing job descriptions, compensation structures, and actual job duties to ensure compliance with FLSA requirements. Proactively consulting with legal counsel allows employers to ensure employees are properly classified as well as ensure that employers have sufficient documentation and evidence to support such classifications should litigation arise.
New Jersey Supreme Court Confirms: Commissions Are Wages Under the New Jersey Wage Payment Law
In a decision with significant implications for employers and employees alike, the New Jersey Supreme Court on March 17, 2025, clarified that commissions constitute wages under the New Jersey Wage Payment Law (“NJWPL”).
In Musker v. Suuchi, Inc. et al., the Court reversed the rulings of both the trial court and the Appellate Division, holding that commissions paid for an employee’s labor or services “always constitute a wage under the WPL.”
In drawing its conclusion, the court focused on the NJWPL’s definition of “wages,” which is defined as “direct monetary compensation for labor or services rendered by an employee, where the amount is determined on a time, task, piece, or commission basis.” N.J.S.A. 34:11-4.1(c) (emphasis added).
Case Background
Rosalyn Musker, the plaintiff in the case, was a sales employee at Suuchi, Inc., a technology-driven fashion supply chain platform. Her compensation included an $80,000 base salary and sales commissions under Suuchi’s Sales Commission Plan. Traditionally, she sold software subscriptions to apparel companies.
However, as the COVID-19 pandemic hit in 2020, Suuchi pivoted its business model and began selling personal protective equipment (PPE)—and Musker was tasked with selling it. While the company did not formally update the commission plan to reflect this new line of business, it did send an email outlining sales terms for PPE transactions.
Musker delivered results. Yet, when it came time for commission payments, she alleged that the company failed to fully compensate her. She filed a lawsuit under the NJWPL, asserting that her unpaid PPE commissions constituted “wages” that were wrongfully withheld.
Suuchi disagreed, characterizing the commissions as “supplementary incentives”—a term that the NJWPL explicitly excludes from the definition of wages.
The Lower Courts’ Takes
At both the trial and appellate levels, the courts sided with Suuchi. The judges found that because Musker already received a base salary, the PPE commissions were not essential compensation for her services, but rather “extras”—in other words, not protected wages.
But the New Jersey Supreme Court saw it differently—and laid down a clear and employee-friendly interpretation of the law
The New Jersey Supreme Court’s Decision
The NJWPL defines “wages” as “direct monetary compensation for labor or services rendered by an employee, where the amount is determined on a time, task, piece, or commission basis.” (N.J.S.A. 34:11-4.1(c)). The law excludes “supplementary incentives and bonuses” that are calculated independently of regular wages.
The Supreme Court found this statutory language to be “clear and unambiguous.” To reinforce its interpretation, the Court turned to dictionary definitions—focusing on the terms “labor,” “services,” and “commission.” It found that “commission” payments are indeed direct compensation for the labor or services an employee performs—making them squarely within the NJWPL’s definition of wages.
In contrast, “supplementary incentives” are payments meant to motivate employees beyond their required duties. And that’s the critical distinction: commissions like Musker’s were tied to services she was obligated to perform as part of her sales role. Selling PPE became part of her job, even if it was a new product offering. Thus, the Court concluded that Musker’s commissions were wages, not optional incentives.
Takeaways
If an employee earns a commission for work required as part of their job, it is a wage—and must be paid accordingly. For companies operating in fast-moving industries—where roles, duties, and compensation structures shift quickly—this ruling is a timely reminder to reassess how compensation is structured and documented. Informal changes to compensation plans, like the email Suuchi sent regarding PPE commissions, do not absolve employers of their legal obligations.
The consequences for non-compliance with the NJWPL are steep. Employers who fail to pay wages—including commissions—may face not only the amount owed but also liquidated damages (up to 200% of the unpaid wages) and attorneys’ fees.
Jessica Hajdukiewicz, a Law Clerk – Pending Admission (not admitted to the practice of law) in the firm’s New York office, contributed to the preparation of this post.
Jepson Claims No Substitute for Written Description in Patents
Federal Circuit Holds That the Preamble of Jepson-Style Claims Must Be Supported by an Adequate Written Description
U.S. patent claims have a preamble, and, in most cases, the preamble is not limiting.[1] Jepson-style patent claims, however, do typically have a limiting preamble.[2] In Jepson-style claims, the preamble can be used to describe the “conventional or known” elements or steps, followed by a transition phrase such as “wherein the improvement comprises” and then an identification of the elements that “the applicant considers as the new or improved portion.”[3] In other words, the preamble can first recite the prior art and then claim an improvement over the prior art.[4]
In In re Xencor, Inc. (“Xencor”), the Federal Circuit recently held that the preamble in a Jepson-style patent claim must be supported by an adequate written description even though there is an implied admission that most, if not all, of the preamble is known, prior art.[5] Xencor is important because it precludes the use of Jepson-style claims to expand the scope of the written description contained in the patent specification by simply including additional information in the preamble and, thereby, implicitly asserting that the new information is well-known in the art. This is particularly significant for the so-called unpredictable arts, such as the life sciences and chemistry, where the written description requirements are often more stringent.[6]
In Xencor, the Federal Circuit considered whether the preamble of a Jepson-style claim must also meet the written description requirement for patents.[7] Under 35 U.S.C. § 112(a), the specification of a patent must “contain a written description of the invention.”[8] To satisfy the written description requirement of § 112(a), “the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.”[9]
On March 13, 2025, in Xencor, the Federal Circuit rejected the patent applicant’s argument that because the “invention” in a Jepson claim is the improvement, only the improvement, and not the prior art in the preamble, needed sufficient written description.[10] Rather, the Federal Circuit held that the preamble in a Jepson claim requires an adequate written description.[11] In other words, “the applicant must establish that what is claimed to be well-known in the prior art is, in fact, well-known in the prior art.”[12]
In reaching this conclusion, the Federal Circuit explained that when the Jepson format is used, the preamble defines the claimed invention and limits the scope of the claims.[13] Although a Jepson claim is directed to the improvement made to the prior art, the Federal Circuit further explained that “the claim is a singular thing and cannot be separated; its totality is what must have written description support, which necessarily includes support sufficient to lead an ordinary artisan to understand that the inventor did, indeed, possess what the patent contends was in the prior art.”[14] According to the Federal Circuit, “[a] patentee cannot be permitted to use a Jepson claim to avoid the requirement that she be in possession of the claimed invention simply by asserting something is well-known in the art.”[15]
The Federal Circuit further explained that “[t]he amount and content of the disclosure that is necessary to supply an adequate written description will vary depending on factors including the level of knowledge of the person of ordinary skill in the art, the unpredictability of the art, and the newness of the technology.”[16] As with all written description inquiries, the finder of fact conducting a written description inquiry for a Jepson claim may consider not only the disclosures in the patent itself, but also evidence outside the patent in order to understand what a person of ordinary skill in the art would have known.[17]
The patent application at issue in Xencor was related to modifying antibodies with certain amino acid substitutions in order to provide for longer staying power in the body and reduce the need for more frequent treatment.[18] The application included a Jepson-style claim for an improvement of “a method of treating a patient by administering an anti-C5 antibody with an Fc domain.”[19] However, an appellate review panel (“ARP”) and administrative review board (“Board”) both determined that the limitation in the Jepson preamble, the anti-C5 antibodies, was not well-known in the art and the specification did not otherwise contain an adequate written description to support it.[20] As noted by the ARP, “[t]the Specification does not describe what patients with what diseases or conditions can be successfully treated with an anti-C5 antibody. Nor is there a single working example describing treatment of patients with a disease or condition with an anti-C5 antibody possessing the claimed Fc modifications.”[21] Ultimately, the Federal Circuit affirmed the ARP’s and the Board’s rejection of the Jepson claim as unpatentable for lack of written description.[22]
Even before Xencor, Jepson-style claims were infrequently used in U.S. patent applications. Following Xencor, the Jepson format may still prove beneficial in a few specific, limited circumstances. For example, a Jepson-style claim can be used to distinguish one claimed invention from another, particularly when seeking to overcome, or prevent, a double patenting rejection for a similar invention. Likewise, use of the Jepson format is common in some foreign countries, so U.S. applications that originate outside the United States sometimes include Jepson claims.
Jepson-style claims, however, have several disadvantages. In contrast to the general rule, the preamble of a Jepson claim is not only limiting, but Xencor now also requires an adequate written description to support it.[23] In addition, use of the Jepson format is often taken as an implied admission that the previous invention described in the preamble is prior art.[24] While the implied admission can be rebutted, this typically occurs only when the Jepson format was used to avoid a double patenting rejection in a co-pending application.[25]
These potential disadvantages, including the new written description requirement for the preamble, should be considered by a practitioner when deciding whether to draft a claim using the Jepson format. The Xencor decision makes it clear that including a limitation in the preamble of a Jepson-style claim does not automatically mean that it is well-known in the art. Instead, patent practitioners should ensure that there is adequate support to satisfy the written description requirement for the preamble of a Jepson-style claim, either in the patent itself or through extrinsic evidence that conclusively establishes the knowledge of a person of ordinary skill in the art.
Footnotes
[1]E.g., Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354, 1358-59 (Fed. Cir. 2010) (quoting Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002)). Nonetheless, a preamble may limit a claim “if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 2839 F.3d 801, 808 (Fed. Cir. 2001) (quoting Piney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)).
[2] E.g., Catalina Mktg. Int’l, Inc., 289 F.3d at 808 (“Jepson claiming generally indicates intent to use the preamble to define the claimed invention, thereby limiting claim scope”).
[3] Artic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1330 (Fed. Cir. 2019) (quoting 37 C.F.R. § 1.75(e)). This practice was approved in Ex parte Jepson, 243 Off. Gaz. Pat. Office 525, 528 (1917) (“When an applicant presents a claim, as in this case, which does particularly point out his exact invention, there is certainly nothing in the law to interdict his doing it by including the old parts of the structure in a preamble and set apart from the structure which constitutes the real invention.”). The practice has since been codified in 37 C.F.R. § 1.75(e):
When the nature of the case admits, as in the case of an improvement, any independent claim should contain in the following order, (1) a preamble comprising a general description of all the elements or steps of the claimed combination which are conventional or know, (2) a phrase such as “wherein the improvement comprises,” and (3) those elements, steps and/or relationships which constitute that portion of the claimed combination which the applicant considers as the new or improved portion.
[4] Dow Chemical Co. v. Sumitomo Chemical Co., Ltd., 257 F.3d 1364, 1368 (Fed. Cir. 2001).
[5] In re Xencor, Inc., 130 F.4th 1350, 1361 (Fed. Cir. 2025).
[6] E.g., Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1341 (Fed. Cir. 2021).
[7] In re Xencor, Inc., 130 F.4th at 1360-63.
[8] 35 U.S.C. § 112(a).
[9] E.g., Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010); United Therapeutics Corp. v. Liquidia Techs., Inc., 74 F.4th 1360, 1370 (Fed. Cir. 2023).
[10] In re Xencor, Inc., 130 F.4th at 1360-61.
[11] Id. at 1361.
[12] Id. at 1362.
[13] Id. at 1361 (“The invention is not only the claimed improvement, but the claimed improvement as applied to the prior art, so the the inventor must provide written description sufficient to show possession of the claimed improvement to what was known in the prior art.”) (emphasis in original).
[14] Id.
[15] Id. at 1362.
[16] Id.
[17] Id.
[18] Id. at 1354.
[19] Id. at 1354-55.
[20] Id. at 1362.
[21] Id. at 1356.
[22] Id. at 1362-63.
[23] Id. at 1361.
[24] In re Fout, 675 F.2d 297, 301 (C.C.P.A. 1982) (“We hold that appellants’ admission that they had actual knowledge of the prior Pagliaro invention described in the preamble constitutes an admission that it is prior art to them.”); see also Application of Ehrreich, 590 F.2d 902, 909-10 (C.C.P.A. 1979) (“We agree that the preamble elements in a Jepson-type claim are impliedly admitted to be old in the art, but it is only an implied admission.”) (citations omitted).
[25] See Ehrreich, 590 F.2d at 909-10.
Summer Concert (Seizure) Season
The summer concert season is almost here. As the weather warms, artists and fans alike are gearing up for highly anticipated tours, like the Oasis reunion, as well as annual festivals, such as Lollapalooza in Chicago, IL, both of which sold out in under an hour. Undoubtedly, John Doe, bootleg merchandiser, is gearing up too, ready to sell counterfeit summer tour t-shirts outside venues. A recent case out of the Central District of California suggests that if artists want to crack down on John Doe’s sales this summer, it may be wise to wait until the tour is underway and the knock-off sales have begun.
On March 24, 2025, rock band AC/DC filed a complaint and ex parte application for a temporary restraining order (“TRO”), seeking nationwide relief against anticipated but yet-to-be-identified Doe defendants. See Leidseplein Presse, B.V. v. Various John Does, Jane Does, and XYZ Companies, No. 2:25-cv-02585 (C.D. Cal. Filed 03/24/2025). The band sought to seize counterfeit merchandise at the opening date of its upcoming tour and to restrain bootleggers from engaging in further sales across the country. However, on April 4, the federal district court in Los Angeles denied AC/DC’s TRO application on the basis that any injury to plaintiff was hypothetical at this point as the complaint and TRO application did not identify particular individuals or repeat offenders, even though the identities of bootleggers are almost never known, and difficult to ascertain.
To counteract the proclivity of bootlegging, touring artists and promoters employ a creative combination of Federal Rule of Civil Procedure 65 and the Trademark Counterfeiting Act of 1984 to seize and restrain ongoing sales of counterfeit merchandise. This mechanism combines five unusual, often disfavored, litigation tactics: 1) emergency proceedings; 2) ex parte seizure orders; 3) seizure without deprivation hearings; 4) Doe defendants; and 5) nationwide restraining orders. Courts are often uncomfortable with the mechanism, consistently expressing due process concerns, even when granting such orders.
Touring artists and promoters see this strategy as one of the only ways to effectively stem the flood of illegal, bootleg merchandise by sellers who are not easily identifiable and who may not be susceptible to normal service of process and litigation practices. However, with increasing judicial skepticism of the practice, artists are put in a precarious position, especially when faced with lost revenue in the early legs of tours, before hard evidence of actual damages can be shown to a court.
The court declined to issue the TRO AC/DC requested because, in its view, while likely plausible, the potential abuse was not enough to persuade the court to grant the application as it read the complaint as making conclusory allegations based on past experience; i.e., that bootleggers would present themselves at the opening date of the tour. The court expressed concerns about granting nationwide seizure and restraining orders, echoing the due process concerns of other courts around the country.
By contrast, jam band Phish adopted a different strategy with a similar goal, making a motion in the District Court of Massachusetts in summer 2024. See Phish, Inc. v. Various John Does, Jane Does, and ABC Companies, No. 1:24-cv-11749 (D. Mass. Filed 07/08/2024). Phish succeeded in obtaining both a seizure order and a restraining order for the remainder of its tour, stretching from New York to Colorado. Phish made its motion after the tour had begun, once bootleggers were present and the injury was concrete and ongoing. Further, Phish specifically identified the remaining tour dates and cities in which it sought a restraining order, limiting the often-sweeping nature of the nationwide restraining order requests, and apparently alleviating courts’ common discomfort with the perceived lack of due process.
For artists and promoters embarking on summer tours who want to shut down merchandisers of counterfeit concert memorabilia, specificity and certainty are key, even if the offenders are unidentified John Does. The recent court decisions suggest that knowing an injury might occur—even if almost certain—may not be enough to persuade some courts of the need for immediate, temporary relief. Artists and promoters should be specific in the scope of their request, limiting the restraining order to the remaining dates and cities on the tour schedule. By working with courts’ sympathies for mark owners, while simultaneously alleviating courts’ common procedural and due process concerns, artists may be able to rid themselves of bootleggers this summer, and fans can be sure to be offered only the genuine article.
New Seventh Circuit Decision Signals Greater Flexibility for Healthcare Marketing Services
On April 14, 2025, the United States Court of Appeals for the Seventh Circuit issued a decision in a case involving the federal Anti-Kickback Statute (“AKS”) and marketing services that the court framed as an appeal “test[ing] some of the outer boundaries of the [AKS]….”
In United States vs. Mark Sorensen, the Court of Appeals overturned the judgment of conviction against Mark Sorensen from the United States District Court for the Northern District of Illinois. In the district court case, Sorensen, the owner of SyMed Inc., a durable medical equipment (“DME”) distributor, was found guilty of one count of conspiracy and three counts of offering and paying kickbacks in return for the referral of Medicare beneficiaries to his DME company, which the United States claimed resulted in SyMed’s fraudulently billing $87 million and receiving $23.6 million in payments from Medicare. The district court judge denied Sorensen’s post-trial motions for acquittal and for a new trial, finding that the evidence regarding willfulness allowed the jury to find beyond a reasonable doubt that Sorensen “knew from the beginning of the agreement in 2015 that the percentage fee structure and purchase of the [doctors’] orders violated the law.” He was sentenced to 42 months in prison and ordered to forfeit $1.8 million.
The charges against Sorensen stemmed from SyMed’s arrangements with several advertising and marketing companies, a DME manufacturer, and a billing company. Under the business model for which Sorensen was convicted, the marketing companies published advertisements for orthopedic braces, to which interested patients could respond using an electronic form providing their names, addresses, and doctors’ contact information. This information was forwarded to call centers where sales agents from the marketing companies would contact the patients to discuss ordering braces and generating prescription forms. After collecting additional information, and with consent from patients to proceed, the sales agents faxed the prefilled, but unsigned, prescription forms to patients’ physicians. The prescription forms contained SyMed’s name and corporate logo and listed the devices to be ordered. SyMed paid the DME manufacturer 79 percent of the payments it received from Medicare or another payor, and kept 21 percent, from which it paid the billing company for its services. The DME manufacturer paid the marketing companies out of its 79 percent share based on the number of leads each company generated. The government argued that the payments to these marketing companies constituted illegal kickbacks under the AKS because they were intended to induce the referral of Medicare beneficiaries.
According to the Seventh Circuit, a critical fact leading to its reversal of Sorensen’s conviction was that the physicians who received these unsigned prescription forms got to decide whether to sign and return the forms to SyMed and the billing company for review—or to ignore them. According to the court’s decision, physicians declined 80 percent of the orders from one of the marketing companies and “regularly ignored forms sent by” the other marketing company.
The appellate court reversed the district court’s decision for insufficient evidence, noting that “[t]he other individuals and businesses Sorensen paid were advertisers and a manufacturer. They were neither physicians in a position to refer their patients nor other decisionmakers in positions to ‘leverage fluid, informal power and influence’ over healthcare decisions.” The Seventh Circuit characterized the marketing companies’ communications to physicians as “proposals for care, not as referrals”, noting that to the extent they could be considered “recommendations” to physicians, “they were frequently overruled.” The appellate court further stated, “[t]he key point is that, on this record, physicians always had ultimate control over their patients’ healthcare choices and applied independent judgment in exercising that control.” Consequently, the appellate court concluded that “Sorensen’s payments thus were not made for “referring” patients within the meaning of the statute.” Interestingly, the court focused more on the percentage payments to the DME manufacturer and less on the “per lead” payments to the marketing companies. This was likely due to the low use or conversion of orders for orthopedic braces by physicians using these prefilled forms by the marketing companies which, to the court, demonstrated that the physicians retained and exercised control over whether an orthopedic brace would be ordered for their patients.
In considering whether the 80 percent declination rate experienced by the one marketing company was dispositive, the Seventh Circuit declined to adopt a bright-line rule. Instead, the appellate court noted in a footnote to its decision that “[o]ur focus is on whether a payee exerts informal but substantial influence so that a physician’s choice of care becomes a formality rather than an exercise of independent medical judgment.”
The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) has previously considered pay per lead arrangements with advertising companies in advisory opinion (“AO”) 08-19. In AO 08-19, the HHS-OIG allowed a pay per lead arrangement involving chiropractors under the limited circumstances presented in that AO: the advertising company was not a health care provider, the advertising did not target only Federal health care program beneficiaries, fees paid by the chiropractors would not depend on whether the lead became an actual patient, and the advertisers would not steer patients to a particular chiropractor. The OIG’s analysis in AO 08-19 also relied on the fact that the advertising company did not collect any health care information, such as payor information, medical history, or diagnosis information about prospective patients using the advertiser’s platform.
The Seventh Circuit’s decision signals that payments to marketing firms for services like advertising and lead generation are less likely to be considered illegal kickbacks, provided that (1) the marketing firms do not exert direct influence over prescribing physicians, and (2) physicians retain genuine autonomy in their medical decisions, in which one factor that may be considered is the conversion rate of a marketing lead to a physician order. While the Seventh Circuit did not provide an explicit definition of the term “referrals” for purposes of the AKS, the court’s emphasis on the independent decision-making of the physicians suggests a potential limit on what actions by a third party can be considered to trigger the AKS’s prohibition against payments for referrals. This could create a clearer path forward for legitimate marketing activities while still prohibiting direct inducements to healthcare providers for specific referrals. We will monitor how other Circuits treat similar issues and report back on our findings.
Federal Court Finds False Claims Act Penalty Unconstitutionally Excessive
On February 26, 2025, the U.S. District Court for the Northern District of Texas issued a significant False Claims Act (FCA) ruling in United States of America ex rel. Cheryl Taylor v. Healthcare Associates of Texas, LLC, finding that the application of the FCA’s mandatory per-claim penalty violated the Eighth Amendment. The Court upheld the jury verdict finding the defendants liable under the FCA, but substantially reduced the $448 million in penalties imposed, citing the Eighth Amendment’s Excessive Fines Clause.
The relator-whistleblower alleged that the defendants employed fraudulent Medicare billing practices in violation of Medicare billing rules. After a two-week trial, the jury found that Healthcare Associates of Texas (HCAT) submitted 21,844 false or fraudulent claims and collected $2,753,641.86 in overpayments.
In assessing potential damages under the FCA, the overpayment amount—roughly $2.75 million in this case—is merely the starting point. The statute allows private whistleblowers or the Government to seek up to three times that amount and to impose penalties between $13,946 and $27,894 for every single false claim. As a practical matter, the Department of Justice often settles FCA cases by applying a multiplier between 1.25 and 2 times the amount of actual damages, while seeking per-claim penalties is far less common.
Relator sought treble damages as well as the maximum statutory penalties. Although the amount of the overpayment was less than $2.75 million, the jury imposed per-claim penalties and awarded Relator $448,817,000—more than 100 times the amount the Government actually reimbursed Defendants for the allegedly fraudulent claims.
HCAT argued that such an award would violate the Excessive Fines Clause, which prohibits “grossly disproportional” fines relative to the offense. The Court agreed, noting that the ratio of statutory to actual damages was over 100 to 1 and that the conduct at issue was based on rules violations as opposed to more egregious conduct like billing for fictitious services. Thus, based on constitutional concerns under the Excessive Fines Clause, the Court reduced the statutory damages to three times the actual damages, setting total liability at $16,521,851.16.
While the FCA mandates per-claim penalties, which often result in extraordinary damage calculations, courts increasingly ask whether they are constitutional and may reduce excessive fines when they result in disproportionate liability. Given these concerns, those facing disproportionally large FCA penalties may consider raising Eighth Amendment arguments early in the litigation, particularly when statutory fines vastly exceed actual damages.
This ruling highlights critical considerations for health care providers and their legal counsel navigating FCA enforcement actions.
Federal Circuit Vacates Summary Judgement: Limitations from Specifications Should Not Have Been Imported Into the Claims
The Federal Circuit vacated and remanded the district court’s summary judgement of noninfringement, finding that the lower court had improperly construed the claim term “pull cord.” The district court had erroneously limited the term to a directly pulled cord that lacks a handle. The Federal Circuit determined that these restrictions were unsupported by the intrinsic evidence and directed the district court to apply the correct claim construction in accordance with the Federal Circuit’s guidance and redetermine infringement using the correct claim construction.
Case Background
IQRIS Technologies LLC sued Point Blank Enterprises, Inc. and National Molding, Inc. in the Southern District of Florida, alleging infringement of U.S. Patent Nos. 7,814,567 and 8,256,020. These two patents share a common specification and are both directed to quick release systems on tactical vests, designed to allow soldiers and first responders to quickly remove their vests in emergency situations. According to the patent specifications, removal and reassembling of prior art tactical vests are time-consuming, and the asserted patents overcome these problems by providing a protective garment with “a reduction in operating parts, faster release, and quicker reassembly than the systems currently in use.”
The accused products – Point Blank’s tactical vests equipped with National Molding’s “Quad Release” and “Evil Twin” quick-release systems – use Bowden cables, which consist of a wire inside a sheath, to activate the trigger, which in turn disengage the vest by releasing the buckles.
During the litigation, the parties disputed the meaning of the team “pull cord” in the asserted claims. IQRIS argued the term should be construed as “a component which, when put into tension, can result in activating the releasable fastener,” while the defendants proposed construing the term as “a cord on the exterior of the ballistic garment grasped by a user that is capable of disengaging the releasable fastener or releasable hook when a user pulls on the pull cord.” The parties also disputed the location of the pull cord, but the district court did not address this issue, and instead construed the term to mean “cord that can be directly pulled by a user to disengage a releasable fastener or releasable hook.” The district court further decided that the patents “disparage” prior art systems that include “a handle that is attached to the cables[.]” Therefore, when analyzing infringement under the doctrine of equivalents, the district court interpreted “pull cord” to exclude pull cords that include a handle. Based on its construction of “pull cord”, the district court granted summary judgement of noninfringement, holding the accused products lacked a claimed “pull cord.”
Issues
The primary issue on appeal was whether the district court had erred in construing “pull cord” to (1) require a user to pull on the pull cord directly; and (2) exclude cords that include a handle.
Holding and Reasoning
1. Directly pulled
The Federal Circuit held that the district court erred in its construction of “pull cord” by imposing requirements that neither the claim language nor the specification supported. The court found that nothing in the claim explicitly required the pull cord to be directly pulled by a user. The claims merely suggest a “pull cord” is a cord that actuates a releasable hook when pulled, without specifying who or what pulls the cord, or whether the pulling is direct or indirect.
While the preferred embodiment depicted a pull cord that is directly pulled, Federal Circuit precedent instructed that limitations from specifications should not be imported into claims when the claims do not expressly require them.
2. Excluding a handle
The court also rejected the district court’s construction that a pull cord cannot include a handle. The patent figures depict a circular ball at the end of the pull cord, which suggests that the inventors contemplated cords with handles. Further, while the patent specification criticizes prior-art cutaway vests for requiring a time-consuming reassembly process, it does not disparage the use of handles. The district court had incorrectly inferred that the pull cord should exclude handles because the specification did not clearly disavow such claim scope where the pull cord includes handles.
Because the district court’s summary judgement was based on an erroneous claim construction, the Federal Circuit vacated the ruling. The court declined to decide whether the accused products infringe under the correct construction, and remanded for future proceedings.
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LEAD LESSON: Court Gives Final Approval to $6.5MM PillPack TCPA Settlement And Its All About Lead Buying
One of the biggest TCPA class certification rulings in recent years was the order certifying the suit against PillPack a few years back.
Another TCPA Certification Disaster: Business Practice in Danger After TCPA Case Certified Against PillPack in Suit Involving Oral Consent to Transfer Calls
The case involved the common practice of a lead generator getting consent to call a consumer and then pitching a third-party’s product– in this case, PillPack’s. However PillPack’s name was not on the form, just the lead generators.
The original certification order was just brutal and massive but then Fluent came forward and assisted with a decertification effort. Still enough risk existed that PillPack went forward with the classwide resolution and agreed to pay $6.5MM.
FLUENT TO THE RESCUE!: Popular Lead Supplier Bails Out Seller With Critical Consent Data Sufficient to Decertify Class
Well in Williams v. PillPack, 2025 WL 1149710 (W.D. Wash April 18, 2025) the court approved the settlement and awarded $2.1MM to class counsel. Each class claimant will receive between $212.00 and $350.00.
$6.5MM is an expensive lesson for lead buyers. And one others in the space are still learning. Lead generators cannot just place calls and transfer to lead buyers unless the buyer is also on the form! It doesn’t matter that the call was placed by the lead generator and the generator was on the form– if the lead buyer isn’t there is significant risk.
Weekly Bankruptcy Alert April 21, 2025 (For the Week Ending April 20, 2025)
Covering reported business bankruptcy filings in Massachusetts, Maine, New Hampshire, and Rhode Island, and Chapter 11 bankruptcy filings in New York and Delaware listing assets of more than $1 million.
Chapter 11
Debtor Name
BusinessType1
BankruptcyCourt
Assets
Liabilities
FilingDate
Francis Trust LLC(New Harbor, ME)
Lessors of Real Estate
Bangor(ME)
$1,000,001to$10 Million
$1,000,001to$10 Million
4/15/25
Creativemass Holdings, Inc.(Melbourne, VIC)
Not Disclosed
Wilmington(DE)
$1,000,001to$10 Million
$1,000,001to$10 Million
4/14/25
Viridos, Inc.(La Jolla, CA)
Electric Power Generation, Transmission and Distribution
Wilmington(DE)
$10,000,001to$50 Million
$1,000,000to$10 Million
4/14/25
Controladora Dolphin, S.A. de C.V.(Cancun, Mexico)
Amusement Parks and Arcades
Wilmington(DE)
$100,000,001to$500 Million
$100,000,001to$500 Million
4/16/25
Arch Therapeutics, Inc.(Framingham, MA)
Medical and Diagnostic Laboratories
Worcester(MA)
$1,000,001to$10 Million
$10,000,001to$50 Million
4/18/25
Arch Biosurgery, Inc.(Framingham, MA)
Medical and Diagnostic Laboratories
Worcester(MA)
$100,001to$500,000
$0to$50,000
4/18/25
Molecular Templates, Inc.(Foxboro, MA)
Pharmaceutical and Medicine Manufacturing
Wilmington(DE)
$1,000,001to$10 Million
$10,000,001to$50 Million
4/20/25
Molecular Templates Opco, Inc.(Foxboro, MA)
Pharmaceutical and Medicine Manufacturing
Wilmington(DE)
$1,000,001to$10 Million
$10,000,001to$50 Million
4/20/25
Chapter 7
Debtor Name
BusinessType1
BankruptcyCourt
Assets
Liabilities
FilingDate
HS Exteriors LLC(Sutton, NH)
Not Disclosed
Concord(NH)
$0to$50,000
$50,001to$100,000
4/14/25
1Business Type information is taken from Bankruptcy Court filings, which may include incorrect categorization by the debtor or others.