Design Patent Obviousness
The landscape of design patent law has recently evolved with the introduction of a new standard for determining obviousness. For decades, the Rosen-Durling test was used to assess obviousness of design patents. The test’s rigid standard resulted in few design patents being invalidated as obvious. In its first en banc decision since 2018, the Federal Circuit overruled the long-established obviousness test in the case of LKQ Corporation v. GM Global Technology Operations LLC.
The Rosen-Durling test had been the standard for evaluating the obviousness of design patents since the 1990s. It involved a two-step process. First, a single primary reference, often referred to as the “Rosen reference,” must be identified, possessing design characteristics that are “basically the same” as the claimed design. If no Rosen reference is found, the assessment ends here. If the first step is satisfied, the second step requires the use of additional references to supplement the primary Rosen reference. These additional references must be “so related” to the primary Rosen reference that applying certain ornamental features from one to the other would be obvious. This rigid framework often made it difficult to invalidate design patents, as challengers had to find a primary reference that was nearly identical to the patented design. The LKQ case represents a significant shift in how obviousness in design patents is evaluated, moving away from the stringent Rosen-Durling test.
General Motors (GM) is well-known for manufacturing automobiles, many of which are protected by intellectual property (IP) rights, including design patents for various components like fenders, bumpers, and headlights. For many years, GM did not produce most of its replacement body parts; instead, it contracted with LKQ to manufacture those parts. Eventually, GM decided to start producing its own replacement body parts, terminating its agreement with LKQ.
Despite the termination of the agreement, LKQ continued to manufacture aftermarket parts for GM—specifically the parts covered by GM’s design patents. In response, GM sent a cease-and-desist letter to LKQ, asserting that LKQ was infringing on approximately 250 different design patents held by GM. In turn, LKQ filed multiple Inter Partes Review (IPR) and Post Grant Review (PGR) petitions concerning various design patents, including an IPR against U.S. Design Patent No. D979,625, which claims the ornamental design for a vehicle front fender.
The Patent Trial and Appeal Board (PTAB) determined that the ’625 Patent was valid when evaluated against prior art on both anticipation and obviousness grounds. Specifically, the PTAB found that LKQ failed to meet step one of the Rosen-Durling test because the primary reference was not “basically the same” as the claimed design. LKQ then appealed to the Federal Circuit.
The panel of the Federal Circuit affirmed the PTAB’s decision, prompting LKQ to request a hearing en banc, which was granted. On appeal, LKQ argued that the Rosen-Durling test was inconsistent with the Supreme Court’s decision in KSR, which advocated for a more expansive and flexible approach to assessing obviousness in utility patents. The en banc Federal Circuit agreed with LKQ, ruling that the Rosen-Durling test was unduly rigid. The court held that the non-obviousness requirement under Section 103 applies equally to both design and utility patents and adopted the Graham factors used for evaluating obviousness in utility patents when assessing design-patent obviousness.
There are four Graham factors to consider when assessing obviousness. The first Graham factor involves determining the scope and content of the prior art. For design patents, this entails identifying a primary reference, which is the piece of prior art that most closely resembles the claimed design. The key requirement for a primary reference is that it must be at least analogous art. The Federal Circuit clarified that “analogous art for a design patent includes art from the same field of endeavor as the article of manufacture of the claimed design.” LKQ Corp. v. GM Glob. Tech. Operations LLC, 102 F.4th 1280, 1297 (Fed. Cir. 2024). This guidance aligns with the current practice in examining utility patents, where only references that are at least analogous to the claimed invention are considered valid for evaluating obviousness. According to the Federal Circuit, the requirement for identifying a primary reference is intended to protect against hindsight bias, ensuring that designs that are less visually similar do not overly influence the determination of obviousness. “Analogous art” includes previous designs from the same field—such as automobile fenders in the LKQ case—or other designs outside the field that would fall within the knowledge of a hypothetical ordinary designer familiar with the type of object being designed. For instance, a nursing pad and necklace adhesive brassier may be analogous art to a flexible garment insert, whereas a teardrop-shaped vase and engagement ring likely would not be.
When evaluating the differences between the prior art designs and the design claim in question, we must follow Graham factor 2. This evaluation does not require a threshold “similarity” criterion. Instead, it involves comparing the overall visual appearance of the claimed design with that of prior art designs from the perspective of an ordinary designer familiar with the type of product in question. The Federal Circuit emphasizes that both the claimed design and the prior art should be assessed based on their overall visual appearances, rather than on the specific similarities or differences of individual elements.
The third Graham factor examines the level of ordinary skill in the relevant field. The Federal Circuit determined that the correct perspective for evaluating whether a design is obvious is that of “a designer of ordinary skill who designs articles of the type involved.” The primary and secondary references do not need to be “so related” that features in one would directly suggest the application of those features in the other. However, both must be considered analogous art to the patented design. Additionally, the motivation to combine these references does not have to come explicitly from the references themselves. It is required that there be some record-supported reason—free from hindsight—that an ordinary designer in that field would have modified the primary reference using features from the secondary reference(s) to achieve an overall appearance similar to the claimed design.
The court confirmed that secondary factors related to nonobviousness (specifically Graham factor 4) should be taken into account for design patents. These factors include commercial success, industry recognition, and acts of copying. However, it was left to future courts to decide whether long-standing unmet needs and the failures of others are relevant in the context of design patents.
So, what does this all mean? The overruling of the Rosen-Durling test is expected to significantly impact the prosecution and enforcement of design patents. The new standard will simplify the process for determining design patent obviousness, likely making it more challenging to secure and protect these patents. Now, the focus will be on whether prior art is considered analogous, which opens up a broader range of references for evaluation.
This new approach encourages a more nuanced, fact-based analysis, allowing for greater consideration of common sense and the knowledge of an ordinary designer. GM raised concerns that overruling the Rosen-Durling test may lead to confusion and inconsistency. The Federal Circuit acknowledged these concerns but noted that there is a substantial body of precedent to guide the Patent Office and courts when assessing obviousness.
While there is undoubtedly less certainty in the near future, the Federal Circuit stated that “[w]hether a prior art design is analogous to the claimed design for an article of manufacturer is a fact question to be addressed on a ‘case-by-case basis.’” LKQ Corp., 102 F.4th at 1297-98. Future cases will help clarify how parties, examiners, and courts should apply the Graham factors and the analogous art requirement to design patents.
How the Lashify Decision Could Expand IP Enforcement Strategies at the ITC to Protect U.S. Domestic Industry
A recent decision by the U.S. Court of Appeals for the Federal Circuit expands which intellectual property (IP) owners can seek relief before the U.S. International Trade Commission (ITC) to block the import of infringing products into the U.S.
Complainants asserting infringement or misappropriation of IP rights (patents, trademarks, copyrights, trade secrets, and mask works) under Section 337 of the Tariff Act of 1930 at the ITC must show that “an industry in the United States . . . exists or is in the process of being established.” This is referred to as the “domestic industry requirement” and has been interpreted by the ITC as requiring satisfaction of both an “economic prong” and a “technical prong.” The “economic prong” requires that the complainant, or a complainant’s licensee, has made in the United States significant investments in plant and equipment, significant investments in labor or capital, or substantial investments in engineering, research and development, or licensing. The “technical prong” requires that such investments must further be directed to articles that practice a valid claim of the asserted patent.
Until now, the ITC has relied on a relatively narrow interpretation of the statute in determining whether certain activities are sufficient to satisfy the economic prong of the domestic industry requirement. Specifically, the ITC excluded certain types of expenditures and activities, such as marketing and distribution, when evaluating domestic industry in the absence of domestic manufacturing.
In Lashify, Inc. v. US International Trade Commission, the Federal Circuit clarifies that Section 337 complainants now may rely on investments or expenses in sales, marketing, warehousing, quality control, or distribution activities to establish a domestic industry, even when the complainant’s articles are manufactured outside the United States. Thus, the precedential opinion by Judge Richard Taranto greatly expands the types of investments, expenses, and activities that a complainant may use to satisfy the economic prong of the domestic industry requirement.
For context, Lashify sells salon-style artificial eyelashes for users to apply at home. Although the products are made overseas, Lashify is a U.S.-based company with extensive domestic operations. The company leases several U.S. facilities and employs more than 100 American workers. Lashify had asked the ITC to investigate alleged patent infringement by competitors that import similar artificial eyelash products into the U.S. However, the ITC determined that Lashify failed to meet the domestic industry requirement under Section 337 because investments and expenses related to sales, marketing, warehousing, quality control, or distribution activities were excluded by the ITC.
The Federal Circuit’s recent March 5 decision vacated the ITC’s ruling and determined that the ITC improperly excluded Lashify’s expenditures on sales, marketing, warehousing, quality control, and distribution. Judge Taranto explained that the plain language of the Omnibus Trade and Competitiveness Act of 1988, which amended the Tariff Act of 1930, shows that the “economic prong” of the domestic industry requirement is satisfied by:
(A) significant investment in plant and equipment;(B) significant employment of labor or capital; or(C) substantial investment in its exploitation, including engineering, research and development, or licensing.
Judge Taranto emphasized that Section 337’s use of the word “or” means that satisfaction of any of these three requirements by a complainant is enough to satisfy the requirement. The decision further clarified that “significant employment of labor or capital” referred to in Section 337(a)(3)(B) covers significant use of “labor” and “capital” without “any limitation” on the type of activities that may constitute such labor or capital. In particular, the statute does not exclude sales, marketing, warehousing, quality control, or distribution activities, nor does it require that such activities be related directly to U.S.-based manufacturing. The evidence showed that Lashify met these requirements.
Additionally, throughout the Lashify opinion, the Federal Circuit cited with approval its previous decision, handed down just last month, in Wuhan Healthgen Biotechnology Corp. v. International Trade Commission. In Wuhan, the Court held that a patent holder’s relatively small investment within the U.S. satisfied the domestic industry prong when all of its research investment occurred within the U.S. and that research investment represented a significant portion of the company’s overall costs, including foreign manufacturing costs. The Court clarified that “[s]mall market segments can still be significant and substantial enough to satisfy the domestic industry requirement” and that “[a] finding of domestic industry cannot hinge on a threshold dollar value or require a rigid formula; rather the analysis requires a holistic review of all relevant considerations that is very context dependent.”
Together, the Lashify and Wuhan decisions open the doors of the ITC to an expanded array of companies that may manufacture products outside the United States but have sales, marketing, distribution, research and development, and perhaps other key non-manufacturing operations in the U.S. These decisions may also potentially expand the patent and other IP enforcement options of foreign companies that satisfy the domestic industry requirement through significant investments in marketing, warehousing, quality control, and distribution in the United States.
The Lashify and Wuhan decisions provide in-house counsel at such companies an additional tool that may be used to protect their IP assets from infringement or misappropriation. Conversely, moving forward U.S. importers may have increased exposure to IP infringement and misappropriation claims before the ITC as well as elevated risk for ITC exclusion orders, as additional IP-holders may now more easily meet the requirements to file ITC complaints. Those existing IP owners having current domestic industries, as well as those looking to invest in US domestic industries to reduce the risk of tariffs or to have enhanced access to US markets, now have expanded ITC enforcement tools to protect their IP assets.
UK-Based Graffiti Artists Sue Vivienne Westwood in California for Misuse of Their Tags
“In a culture where association with philistines is a death knell,” UK-based graffiti and street artists Cole Smith, Reece Deardon and Harry Matthews have brought a lawsuit against Vivienne Westwood and retailers of the brand for the fashion house’s allegedly unauthorized use of their tags “to lend credibility and an air of urban cool” to its apparel. See Smith v. Vivienne Westwood, Inc., Case No. 2:25-cv-01221 (C.D. Cal. Filed 02/12/25). The artists, known professionally as DISA, SNOK and RENNEE, respectively, argue that their tags are, like their name or signature, “deeply personal and determinative of their identity.” In turn, they claim that Vivienne Westwood’s use of their tags falsely represents their endorsement of the fashion house to the consumer and causes “the world to think that they are corporate sellouts, willing to trade their artistic independence, legacy and credibility for a quick buck.”
According to allegations in this and a long string of similar lawsuits by street artists against fashion brands like Moschino, Roberto Cavalli, Guess?, North Face and Puma, the use of graffiti artists’ tags on apparel purportedly generates “huge revenues” for brands based on their supposed affiliation with the artists. Those familiar with the legacy of Vivienne Westwood’s eponymous founder as a punk icon (far from a philistine) might agree that her brand illustrates the profitability of incorporating urban counterculture into retail fashion.
Yet, the extent to which DISA, SNOK and RENNEE may recover their alleged damages as UK-based artists before the US District Court for the Central District of California remains an open question. While these artists may pursue their copyright infringement claims under the Berne Convention without having registered their tags in the United States Copyright Office, they probably are not entitled to recover either statutory damages or attorneys’ fees without US registrations. Additionally, although they may have a viable claim that their tags are copyright management information subject to the Digital Millenium Copyright Act (17 U.S.C. § 1202) — as other courts in the Central District ruled in the cases against Moschino and Roberto Cavalli — their claims under California’s right of publicity statute (Cal. Civ. Code § 3344) may be somewhat less certain. There is a dearth of precedent for extending the protections of California’s right of publicity statute to out-of-state residents, even if the court, as in the case against Moschino, finds that a graffiti artist’s tag is a name in a literal sense.
Therefore, this case has the potential to better define the legal landscape faced by foreign street artists pursuing copyright infringement in the United States and right of publicity claims in California. Still, the lawsuit is at its infancy and, similar to the cases against other retailers, may settle before being fully litigated on its merits. We will continue to monitor this case and provide updates as it develops.
DC Circuit Affirms Decision That Copyright Statute Requires Some Amount of Human Authorship, Leaves More Difficult Questions for Another Day
Does copyright law require that a human create a work? Yesterday the D.C. Circuit in Thaler v. Perlmutter held that it does and that a machine (such as a computer operating a generative AI program) cannot be designated as the author of the work. However, the D.C. Circuit refrained from saying more for now, leaving other questions about the use of AI when creating works for another day.
Dr. Stephen Thaler, a computer scientist who works with artificial intelligence, submitted a copyright application in 2019 for the image below, which he titled “A Recent Entrance to Paradise.” On the application, Thaler identified himself as the claimant, while designating a generative AI platform that he created and called the “Creativity Machine” as the author. For explanation of how the copyright was transferred from the machine as author to himself as claimant, Thaler stated his “ownership of the machine” caused the transfer. He would later argue that some form of work-for-hire transferred ownership to himself.
The Copyright Office denied registration, holding that copyright law requires a human author. Thaler appealed the decision to the District Court for the District of Columbia, which affirmed. As part of his case before the district court, Thaler raised, for the first time, the argument that he was in fact the author based on his creation of the Creativity Machine. However, because he had claimed on the record that the machine was the author throughout the proceedings before the Copyright Office, the district court held that he had waived this argument. Thaler then appealed to the D.C. Circuit Court of Appeals.
The D.C. Circuit’s decision yesterday affirmed both the Copyright Office’s and the district court’s decisions refusing Thaler’s copyright application for registration. On the key issue of copyright authorship, the court held that the text and structure of the Copyright Act requires a human author. Section 201 of the Copyright Act states that ownership “vests initially in the author or authors” of a work. While “author” is undefined, the court looked to at least seven other provisions throughout the Copyright Act that required various acts or states of mind of the author. These included reliance on the author’s life, references to the author’s widow or widower and children, the act of signature required for copyright transfer, and the intent needed to create a joint work of authorship. However, the court deemed none of these requirements applicable to a machine “author.” The court also relied on the Copyright Office’s long-standing policy of refusing registration to nonhuman authors and other appellate court decisions by the Seventh and Ninth circuits that refused claims of copyright authorship inhering in nature, “otherworldly entities,” or animals. Finally, the court held that Thaler’s work-for-hire claim failed at least because the machine had not signed any document designating the work as being made for hire, and that he had waived any claim of personal authorship because he had failed to raise it before the Copyright Office. Therefore, the D.C. Circuit affirmed the denial of registration of the work with the Creativity Machine designated as the author.
While this case is the first to address the question of copyright authorship in the context of generative artificial intelligence, its holding is not unexpected. As briefly referenced above, other appellate courts have addressed the question of nonhuman authorship in other scenarios and come to the same conclusion. Therefore, while Thaler is important for extending the same holding to the context of AI creations, the requirement of human authorship is neither new nor unusual. As the Ninth Circuit held in Naruto v. Slater (a case involving the famous “monkey selfie” photograph), there is a strong presumption in the law that statutes are written with humans as the subjects of rights, not animals or machines. The numerous textual references to the lives, acts, and intentions of authors in the Copyright Act made it easy for the D.C. Circuit not to overturn that presumption here. The D.C. Circuit also held that it did not need to address whether the U.S. Constitution requires a human author under the current case. That issue is left for a future litigant to contend with.
Moreover, Thaler presented his case for machine authorship in the most extreme form possible — a claim that the author was solely the “Creativity Machine,” with no human input at all. As the court references late in the decision, there have now been at least four copyright applications denied registration in whole or in part by the Copyright Office because the author used AI in creating or editing a work, but also relied on human input and human claims of authorship. The D.C. Circuit wisely decided to let that issue await a future ruling. Yet, as a result of that caution, litigants should recognize the limitations of the Thaler decision.
Finally, both Thaler and the other cases coming through the Copyright Office only concern AI creation of visual works of art. They do not concern other fields of creative works, such as written works or music. While the main holding of Thaler — that copyright protection cannot be granted where a machine is the sole creator — will certainly apply in these other fields, the permissible contours of AI-human interaction and their effect on authorship in these other categories of works are even more unclear given the lack of disputes arising to date.
China’s National Development and Reform Commission: High-Value Invention Patents per 10,000 People Reached 14
On March 11, 2025, the National People’s Congress approved the China’s National Development and Reform Commission report on the 2024 implementation of China’s economical and social development and draft plan for 2025. Of note, the number of high-value invention patents per 10,000 people reach 14, exceeding the 2025 goal of 12 high-value patents per 10,000 people in China’s National Intellectual Property Administration’s (CNIPA) 14th five-year plan.
Closing of the third session of the 14th National People’s Congress.
Per China’s National Intellectual Property Administration (CNIPA), a high-value patent includes:
A patent in the strategic emerging industries;
A patent with overseas patent family member(s);
A patent maintained for more than 10 years after grant;
A patent that realizes a higher amount of pledge financing (secured debt); or
A patent that wins State Science and Technology Awards or the China Patent Awards.
Intellectual property-related excerpts from the report follow:
Guidelines on improving the market access system were issued, and evaluations of market entry efficiency were conducted across the board. An initiative was launched to build up the system for protecting intellectual property rights (IPR), the initiative to promote the practical application of patents was fully implemented, and reform was advanced to integrate prosecutorial powers over civil, administrative, and criminal cases involving IPR.
We accelerated efforts to improve the foundational system for all-around innovation and sped up the translation of technological advances into higher productivity. Per capita labor productivity reached 174,000 yuan, a 4.9% increase in real terms. Spending on research and development (R&D) hit 3.6 trillion yuan, an increase of 8% in real terms. Investment in basic research accounted for 6.91% of the country’s total R&D spending, and the number of high-value invention patents per 10,000 people reached 14.
The mechanisms for inter-regional cooperation saw steady improvements. Practical results were achieved in promoting industrial connectivity and cooperation, improved environmental protection through joint efforts, sharing of public services, and the flow of officials and high-caliber personnel across regions. Trans-regional collaboration was enhanced in terms of testing and inspection, intellectual property rights, and oversight. Tax-related issues can now be dealt with across regions at a faster pace, with more than 530,000 trans-regional cases being handled by tax payment service centers across the country.
We will establish a sound system for the comprehensive management of intellectual property rights and effective mechanisms for responding to overseas IP disputes and facilitate improvements to the system enabling IP courts to handle cross-regional cases. We will take the initiative to align with high-standard international economic and trade rules, harmonizing domestic policies and regulations with relevant international rules. We will improve customs clearance procedures and facilitate the building of the Single Window System for international trade.
The full report is available here (Chinese) and here (English).
Court Rules AI Cannot Be Copyrighted: Landmark Ruling on Human Authorship
Court Rules AI Cannot Be Copyrighted: Landmark Ruling on Human Authorship. In a pivotal decision, the U.S. Court of Appeals for the D.C. Circuit ruled that copyright protection requires human authorship, rejecting the idea that AI-generated works can be copyrighted. This decision represents a significant setback for efforts to grant intellectual property rights to creations […]
China Remains Top Source of Patent Cooperation Treaty (PCT) Applications in 2024
According to data released by the World Intellectual Property Organization (WIPO) on March 17, 2025, China remained the top source of PCT applications in 2024. Reversing a slight decrease in Chinese-originated PCT filings in 2023, China’s PCT filings increased to 70,160 applications up almost 1% on 2023. The United States follows China with 54,087 applications in 2024 – the third consecutive decline.
International patent applications by origin.
Huawei Technologies was the top PCT filer in 2024, with 6,600 published applications, followed by Samsung Electronics (Republic of Korea, 4,640 applications), Qualcomm (US, 3,848), LG Electronics (Republic of Korea, 2,083) and Contemporary Amperex Technology (China, 1,993). Other top Chinese filers include BOE Technology Group Co., Ltd., ranked sixth with 1,959 applications and Beijing Xiaomi Mobile Software Co., Ltd., ranked eighth with 1,889 applications.
Top PCT applicants
China’s education institutions also placed highly. Top Chinese universities include Tsinghua University, ranked third among educational institutions with 188 applications and Zhejiang University ranked fourth among educational institutions with 175 applications.
Top PCT applicants by educational institution
The full data set is available here.
Federal Circuit Touches on Appellate Standing and Prior Art Determinations in the Context of Post-Grant Review Proceedings
In CQV Co. Ltd. v. Merck Patent GmbH, the Federal Circuit addressed (1) the interaction of indemnification agreements with Article III standing for appeals of post-grant review decisions of the Patent Trial and Appeal Board; and (2) whether all evidence must be addressed by the Board when qualifying prior art.
Background
Merck Patent GmbH (“Merck”) owns U.S. Patent No. 10,647,861 (the “’861 Patent”), which is directed to the composition of an additive flaking for paints, industrial and automotive coatings, printing inks, cosmetics, and effect pigments. Merck sold pearlescent pigments utilizing the invention of the ’861 Patent under the trademark Xirallic.
CQV Co. Ltd. (“CQV”) sells a competing pearlescent pigment under the trademark Adamas. Merck sent communications to CQV customers alleging that CQV’s Adamas products potentially infringed Merck’s ’861 Patent. CQV petitioned the Board for post-grant review of the ’861 Patent in February 2021.
Before the Board, the parties disputed several issues. One of these issues was the prior art status of an early batch of Xirallic named “Sample C.” In its August 2022 final written decision, the Board held that CQV had not provided adequate evidentiary support to show that Sample C constituted prior art.
CQV appealed the decision to the Federal Circuit, arguing that the Board did not consider relevant evidence. Merck challenged CQV’s Article III appellate standing.
Issues
Did CQV have adequate Article III standing to appeal the Board’s final written decision to the Federal Circuit?
Did the Board err in finding that CQV failed to show, by a preponderance of the evidence, that Sample C constituted prior art against Merck’s ’861 Patent?
Reasoning and Outcome
(1) CQV did have adequate Article III standing to appeal the Board’s final written decision to the Federal Circuit.
As the party appealing a final written decision by the Board, CQV had the burden of showing that it suffered an injury in fact sufficient to confer Article III standing. Gen. Elec. Co. v. United Techs. Corp., 928 F.3d 1349, 1353 (Fed. Cir. 2019). To establish injury in fact, it is generally sufficient to show that the appellant “has engaged in, is engaging in or will likely engage in activity that would give rise to a possible infringement suit.” Grit Energy Sols., LLC v. Oren Techs., LLC, 957 F.3d 1309, 1319 (Fed. Cir. 2020).
CQV filed declarations alleging that CQV had entered into an indemnification agreement with at least one customer as a result of Merck’s communications. According to the Federal Circuit, although Merck’s communications did not identify any specific CQV product as infringing Merck’s ’861 Patent, standing does not require such a specific assertion of infringement by a patentee.
Because at least one customer purchased CQV’s Adamas product in the US, Merck communicated with that customer, and CQV formed an indemnity agreement with that customer, CQV had established Article III standing to appeal the Board’s final written decision.
(2) The Board erred in finding that CQV failed to show, by a preponderance of the evidence, that Sample C constituted prior art against Merck’s ’861 Patent.
In a post-grant review, the petitioner bears the burden to show that an asserted reference qualifies as prior art by a preponderance of the evidence. To meet this burden CQV presented several pieces of evidence relating to the prior art status of Sample C. The Board’s decision did not address two items of testimonial evidence: testimony that Xirallic could generally be purchased by customers after it was released by quality control, and testimony that the quality control for the Adamas products required two to three weeks. The Board held that the other pieces of evidence, taken together and unrebutted, failed to establish that Sample C was probably available to the public before the April 30, 2012 critical date.
“The Board is obligated to articulate a satisfactory explanation for its action, including a rational connection between the facts found and the choice made.” Alacritech, Inc v. Intel Corp., 966 F.3d 1367, 1372 (Fed. Cir. 2020). “Failure to explicitly discuss every issue or every piece of evidence does not alone establish that the tribunal did not consider it,” Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017). The Federal Circuit characterized the testimony omitted by the Board as “highly material and unrebutted evidence” that Sample C was available to the public before the critical date.
Because the Board discarded this testimony evidence without explanation, the Federal Circuit could not reasonably discern whether the Board followed a proper path in determining that CQV failed to show that Sample C constituted prior art. The Federal Circuit vacated the Board’s decision and remanded with instructions for the Board to explain its reasoning with respect to all the evidence presented.
Make Protecting Your UK and EU Product Packaging and Labels Your New Year’s IP Resolution. Part 2: Combatting Dupes and Copycats in the United Kingdom
Everybody knows that trade marks are necessary to protect a brand’s logo and name, and a lot of people know that registered designs are a powerful tool in stopping counterfeit goods, but did you know these rights can also be used to help protect against unwanted “dupes” (also known as “copycat” or “lookalike” products)? Dupes/copycats deliberately mimic a successful product, and they imitate the look and feel to unfairly benefit from the goodwill attached to the product through the “halo effect,” i.e., the impression that if it looks like the original, it must be as good.
Dupes in the United Kingdom
However, there have been some useful cases over the last few years, including a very beneficial UK Court of Appeal case handed down in January this year, and each contains helpful guidance for brands looking to use registered designs and trade marks to protect against dupes and lookalikes:
There is ever a lament from brands that there are not enough legal tools in the United Kingdom to prevent copycats from using a hero product’s unique look, feel or effect to maximise their own sales. We can see this through a long line of caselaw where a passing off claim (an English law tort where a trader misrepresents its goods or services as being those of another) has failed to meet the high threshold of “misrepresentation,” i.e., consumers must actually be deceived and believe the goods to be those of the claimant.
In January 2025, Thatchers won its appeal against the decision in January 2024, and it successfully established that supermarket Aldi infringed its trade marks by selling a copycat cider with similar labelling to Thatchers’ cloudy lemon cider packaging (see our articles here and here).
Thatcher’s Trade MarkNote: The UK Court of Appeal found the judge had erred by not considering the three-dimensional use of the Thatchers’ mark as printed on the packaging and can.
Aldi’s Product
Key points to note:
The UK Court of Appeal found that the Aldi cider “rode on the coat-tails” of Thatchers’ cider, that Aldi purposefully intended to remind consumers of Thatchers’ trade mark, and that it was “entirely possible” to convey that a drink is lemon-flavoured without such a close resemblance; therefore, the similarity “cannot be coincidental.”
Aldi benefited by achieving significant sales with no promotional spending as a result of the “transfer of image,” which created an “unfair advantage.”
The Thatchers’ mark was found to have reputation despite a relatively short period of sales.
In March 2024, Lidl succeeded in upholding the decision that Tesco had infringed its trade marks (see our article here). Although this case it not a “dupe” or copycat case per se, it shows the power of clever trade mark registration strategies, as well as the importance of having trade mark registrations for key elements of branding.
Lidl’s Trade Marks
Tesco’s Sign
Key points to note:
The court found that a substantial number of customers would be misled into thinking that Tesco’s clubcard scheme and prices were a price-match to Lidl for equivalent goods.
In February 2024, the UK Court of Appeal upheld the decision that Aldi had infringed Marks & Spencer’s (M&S’s) registered designs, as their gin bottles did not create a different overall impression on the informed user (see our articles here and here).
M&S’s Design
Aldi’s Product
Key points to note:
The similarities between the designs were found to be “striking.”
A wide design freedom was found, which further highlighted the similarity between the products.
In 2021, William Grant & Sons, maker of Hendrick’s Gin, succeeded in its claim in Scotland for interim relief against the sale of Lidl’s Hampstead Gin. The claim was successful because they were able to show reputation in the Hendrick’s Gin trade mark and that the Hampstead product took unfair advantage of, or was damaging to, the distinctive character or the repute of the Hendrick’s Gin trade mark.
Key points to note:
The claim failed on passing off and a pure infringement claim.
Similarity was found in the dark, apothecary-style bottle, as well as the diamond label shape.
The claim was ultimately successful because of the reputation in the Hendrick’s Gin bottle, so there was no need to demonstrate customer confusion.
Key Learning for Brands
Designs
For new products, register a design wherever possible, as it is easier to succeed in a claim for infringement, and there is also no initial validity review of designs by the UKIntellectual Property Office.
There is no need to prove confusion or reputation for design infringement claims; a claimant only needs to show the same overall impression on the informed user. This can mean less legal spend on obtaining “confusion” and “reputation” evidence.
You can file a registered design in the United Kingdom (and the European Union, if relevant) with a deferred publication date if the release is not immediate to protect the design as soon as possible.
Designs can protect the product’s appearance in whole or in part for unique stylistic elements, such as lines, contours, colours, shapes, texture and materials (e.g., sole patterns on footwear).
Trade Marks
When developing a product or considering protection for a product already on the market, think about what trade marks could be filed to protect the look/feel of the label or product. In particular, consider the following:
The shapes and colours of the product and label.
Filing simplistic versions of the packaging or labelling design, e.g., filing a label without the brand name if certain elements are unique enough.
Filing monochrome versions of the marks, as well as colour marks if the pattern/imagery is distinctive.
Any stylistic positioning elements that could be filed as position marks (although careful drafting is necessary to make sure the trade mark is sufficiently clear to be enforceable (see Thom Browne v Adidas)).
If the overall shape of the product could be a 3D mark.
If it is a product with reputation, think carefully about what makes the product unique and how it stands out in the market.
A word of caution on trade marks: you must have an intention to use or already use the trade marks in some way and cannot only file the trade marks as a legal weapon.
We have not touched on copyright here, but if design and trade mark claims are not available, a claim under copyright could be another avenue to explore.
Part 1 of this series on protecting unique packaging designs in the European Union can be found here.
Delaying Examination of Continuing Applications Could Sabotage USPTO Goals
Rumor has it that one of many behind-the-scenes changes being implemented at the USPTO relates to how (or when) continuing applications are taken up for examination. Typically, an examiner may give priority to a continuing application based on its U.S. priority date. That could change, with placement in the examination queue being based on the actual filing date of the continuing application itself. This effort to move continuing applications to the back of the line may be spurred by a narrative that continuation applications are a burden on the USPTO and hindrance to competition, but its implementation could sabotage important USPTO’s goals.
Loss of Examination Efficiency
One reason an examiner may choose to give priority to a continuing application is an expectation that it will be relatively easy to examine. The examiner is already familiar with the technology and the prior art, and so can immediately focus on evaluating patentability of the claims. Moving continuing applications to the end of the examination queue would lose these efficiencies. The current average time to examination is over 20 months and climbing. With a two year gap between examination of a parent application and its child, it is likely the examiner will have to spend more time getting reoriented to the subject matter of the application and its place in the state of the art.
Loss of Maintenance Fee Revenue
A more concrete impact of de-prioritizing examination of continuing applications is the consequent loss of maintenance fee revenue. The current USPTO fee schedule includes a new surcharge for continuing applications filed “late” in their 20-year term that is designed to “partially offset foregone maintenance fee revenue.” The USPTO justified the new fee by explaining that maintenance fee payments are essential to the USPTO’s fiscal health, “account for about half of all patent fee collections,” and “subsidize the cost of filing, search, and examination activities.” So, why would it implement internal changes that will leave more maintenance fees on the table?
Maintenance fees are due 3.5, 7.5 and 11.5 years after a patent grants, but a patent’s potential term is measured from its earliest non-provisional U.S. priority date. This means a patent granted more than 8 years after its priority date may expire before one or more maintenance fees must be paid (as illustrated in the USPTO’s figure below). But this also means the USPTO has incentive to expedite the examination and grant of continuing applications.
This figure assumes a continuing application will be granted 30 months from its actual filing date, but also illustrates how delays in grant can cause one or more maintenance fee deadlines to fall off the chart and not be paid.
Take a continuing application filed just after 6 years from the start of its 20-year term (between Child C and Child D in the figure) and subject to a new surcharge of $2700. If this application is granted after 30 months (2.5 years), its 20-year term will expire just as the third maintenance fee would be due (M3 in the figure), so that fee will not be paid. On the other hand, if the patent is granted within 1.5 years, it is at least possible the patent owner would want to maintain it for another year—and probable if it is protecting an approved pharmaceutical product. At current maintenance fee rates, that means the USPTO is potentially losing $8,280 per application by not striving to expedite examination and grant of continuing applications subject to the $2700 surcharge.
A continuing application filed just after 9 years from the start of its 20-year term (between Child D and Child E in the figure) and subject to a new surcharge of $4000 is never going to pay the last maintenance fee, but the sooner the patent is granted, the more likely the patent owner will want to pay the second maintenance fee (M2 in the figure), which currently is $4040. If it takes 30 months to grant, the second maintenance fee will be due one year before expiration of the 20-year term, but if it takes only 18 months to grant, there will be two years left when the second maintenance fee falls due. That means by expediting examination and grant of continuing applications subject to the $4000 surcharge the USPTO could double the incentive to pay the $4000 maintenance fee.
Data-Driven Decision Making
In this era of data-driven decision making, the USPTO should be able to mine its examination metrics to confirm that prompt examination of continuing applications supports an efficient examination process, and it should be even more straight-forward to mine maintenance fee payment metrics to estimate the additional maintenance fee revenue that could be generated by prioritizing examination and grant of continuing applications. When crunching the numbers, the USPTO should take into account that patent owners willing to pay the new surcharges already place a high value on these applications, and so may be more likely to pay maintenance fees that fall due toward the end of the patent’s 20-year term.
If the data indicate that putting continuing applications at the back of the line undermines USPTO examination goals and exacerbates loss of maintenance fee revenue, the USPTO should revoke its decision to de-prioritize examination of continuing applications. In the meantime, stakeholders should be aware of the USPTO’s negative view of continuing applications, and look for opportunities to rebut the narrative that continuing applications are less deserving of the USPTO’s examination resources than so-called “new” applications.
5-Year Prison Term for Counterfeiting Burberry in China
On March 13, 2025, the Shanghai Procuratorate Third Branch announced that the Shanghai Third Intermediate People’s Court upheld a 5-year prison term and 2 million RMB fine for the crime of counterfeiting registered trademarks belonging to Burberry. In 2021, the defendant, Gong XX, resumed operating an online store “XXX Overseas Shopping” and started selling counterfeit Burberry brand clothing. The cost of making a single piece of clothing involved in the case ranged from 500 to 700 RMB, but the selling price could reach 3,500 RMB per piece. From 2021 to 2023, Gong sold the clothing involved in the case in his own online store and WeChat Moments, with sales reaching more than 4 million RMB.
Counterfeit clothing involved.
In February 2023, the Jing’an Temple Police Station received a report from the public that they spent thousands of RMB to buy a brand-name windbreaker from the “XXX Overseas Shopping” online store, but found that it was a fake. Based on the evidence, the public security organs quickly launched an investigation and arrested the suspect Gong. Afterwards, the Jing’an District Procuratorate indicted Gong at the Jing’an District Court in accordance with the law on the grounds that Gong committed the crime of counterfeiting registered trademarks. In November, the court made a first-instance judgment, sentencing Gong to five years in prison for the crime of counterfeiting registered trademarks and a fine of RMB 2 million. Gong appealed to the Shanghai Third Intermediate People’s Court. In February 2024, the court ruled on the second instance of the counterfeit registered trademark case handled by the Third Branch, dismissing Gong’s appeal and upholding the original judgment.
On February 23, 2024, the Shanghai No. 3 Intermediate People’s Court held a second-instance trial of the case, and the prosecutor in charge of the Third Branch attended the court.
During the trial, Gong argued that his “Knight” graphic was different from the mark registered by Burberry. However, the prosecutor pointed out that identical trademarks include not only “completely identical” but also “basically indistinguishable.” The Burberry trademark has been widely used and promoted for a long time, and has a high market visibility and strong distinctiveness. Comparing Gong’s counterfeit logo with the registered trademark of the right holder, there is basically no difference in the overall shape and arrangement of elements, with only slight differences in individual lines, which makes it impossible for ordinary consumers to distinguish them in appearance, thus misleading the public. Therefore, the “Knight” graphic trademark used by Gong can be identified as “a trademark identical to the registered trademark”.
During the trial, Gong also argued that the “BURBERRY BLACK LABEL” text trademark has not been used in China for several years, and the series of clothing is only sold in a certain country and has been discontinued. Based on this, he believed that reference should be made to the relevant provisions in the civil field where infringers of trademarks “not used for three consecutive years without justifiable reasons” may not be liable for compensation, and thus his counterfeiting behavior should not be considered a crime in the criminal field.
The prosecuting attorney pointed out that China’s criminal law currently does not have special provisions for the above situation. According to the certification letter issued by Burberry and the series of trademark registrations, “BURBERRY BLACK LABEL” is a legally registered trademark in China and is within the validity period, approved for use on clothing products, and should be protected by law. At the same time, the products of the involved text trademark still circulate in the secondary market in China, and the “BURBERRY BLACK LABEL” text trademark still plays the core function of identifying the brand.
In addition, “BURBERRY” itself is also a registered trademark of Burberry. The arrangement of the “BURBERRY BLACK LABEL” word trademark is: “BURBERRY” and “BLACK LABEL” are arranged in separate lines, and the “BURBERRY” word is enlarged, bolded and highlighted. “BLACK LABEL” itself only means “black label”, which is a common industry term for distinguishing product categories and is not a distinctive element of the trademark. According to regulations, if only the common name of the product, model number and other elements lacking distinctive features are added to the registered trademark, and it does not affect the distinctive features of the registered trademark, it can be determined as “a trademark identical to its registered trademark.”
The original announcement is available here (Chinese only).
Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112
Synopsis:
In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera, Inc. (Natera) against its competitor CareDx, Inc. (CareDx).1 In January 2024, a jury found that two of CareDx’s cell-free DNA (cfDNA) blood tests (AlluSure and AlloSeq) infringed two of Natera’s patents and awarded Natera damages of approximately $96 million.2 CareDx filed a motion for judgment as a matter of law, asking Chief Judge Connolly to find the asserted patents invalid for lack of written description under 35 U.S.C. § 112. On February 24, 2025, Judge Connolly granted CareDx’s motion and found the asserted claims of Natera’s patents invalid for lack of written description.3
1. Patent Dispute Between CareDx and Natera: Background and Claims
CareDx sells AlloSure and AlloSeq—blood tests that are used to assess whether a transplanted kidney is being rejected by the recipient’s body. Specifically, AlloSure and AlloSeq are used to detect cfDNA, which “is fragmented DNA in the bloodstream that originates from cells undergoing cell injury and death.”4 When a transplanted kidney is being rejected, “donor-derived cell-free DNA (dd-cfDNA) increases in the blood” of the transplant recipient.5 AlloSure and AlloSeq allow for the detection of dd-cfDNA in a transplant recipient’s blood.
Natera asserted two patents, U.S. Patent Nos. 10,655,180 (the ’180 patent) and 11,111,544 (the ’544 patent) (collectively, the “asserted patents”), related to methods for preparing, amplifying and detecting cfDNA.6 Relying on the insight that dd-cfDNA will be present in different fractions depending on whether the transplanted kidney is being accepted or rejected by the recipient, Natera’s patent claims were directed to extracting and amplifying cfDNA from a patient at given locations on the genome:
A method for preparing a preparation of amplified DNA derived from a biological sample of a second individual useful for determining genetic data for DNA from a first individual in the biological sample, the method comprising:
Extracting cell-free DNA from the biological sample;
Preparing a preparation of amplified DNA by amplifying a plurality of target loci on the cell-free DNA extracted from the biological sample to generate amplified DNA;
Analyzing the preparation of amplified DNA by sequencing the amplified DNA using sequencing-by-synthesis to obtain genetic data of the plurality of target loci, and determining the most likely genetic data for DNA from the first individual based on allele frequencies in the genetic data at the plurality of target loci.
Asserted claim 14 of the ’180 patent recites a similar method, directed to identifying SNPs (Single Nucleotide Polymorphisms), as a way of assessing the relative amount of DNA in each sample:
A method for measuring an amount of DNA in a biological sample, the method comprising:
Performing a targeted PCR amplification for more than 100 SNP loci on one or more chromosomes expected to be disomic in a single reaction mixture using more than 100 PCR primer pairs, wherein the reaction mixture comprises cell-free DNA extracted from a biological sample of a subject comprising DNA of mixed origin, wherein the DNA of mixed origin comprises DNA from the subject and DNA from a genetically distinct individual, wherein neither the subject nor the genetically distinct individual is a fetus, wherein the DNA of mixed origin comprises DNA from a transplant, and wherein the amplified SNP loci comprise SNP loci on at least chromosome 1, 2, or 3;
Measuring a quantity of each allele at a plurality of amplified SNP loci that comprise an allele present in the genetically distinct individual but not the subject, wherein the quantity of each allele at a plurality of amplified SNP loci are measured by high-throughput sequencing;
Measuring an amount of the DNA from the genetically distinct individual in the biological sample using the quantity of each allele at the SNP loci and an expected quantity of each allele at the SNP loci for different DNA fractions,
Wherein the method is performed without prior knowledge of genotypes of the genetically distinct individual.
At trial, CareDx argued, among other things, that the asserted claims were invalid for lack of written description under 35 U.S.C. § 112. The jury disagreed and found that the asserted patents were not invalid.
CareDx filed a motion for judgment as a matter of law under FRCP 50(b), arguing that no reasonable jury could find that the specifications of the asserted patents satisfy the written description requirement in view of the evidence presented at trial.
2. Judge Connolly’s Opinion
Beginning with the ’544 patent, Judge Connolly explained that claim 21 recites “a method by which (1) cell-free DNA is extracted from a biological sample of one individual (i.e., the ‘second individual’); (2) target loci on the extracted cell-free DNA is ‘amplified’ and ‘sequenc[ed by] synthesis to obtain genetic data’; and (3) ‘the most likely genetic data’ for DNA from another individual (i.e., the ‘first individual’) in the obtained genetic data is ‘determin[ed]’ from that data ‘based on allele frequencies.’”7 Thus, to satisfy the written description requirement, the specification must show that the inventors possessed the full scope of this claim, including the individual claim elements and all three claim elements “as an integrated whole.”8
Judge Connolly first focused on whether the specification “adequately describes the combination of the claimed steps as an integrated whole.”9 CareDx’s expert, Dr. Brian Van Ness, testified that the specification does not describe all three of the claimed steps being performed in combination. Dr. Van Ness’s testimony was largely unrebutted—Natera cited only two passages from the specification, admitted that the specification lacked working examples, and otherwise relied on the testimony of its expert, Dr. John Quackenbush.
Judge Connolly found Dr. Quackenbush’s testimony “conclusory” and “‘far too general’” to support the jury’s decision.10 Specifically, Dr. Quackenbush “never pointed to any text in the patent’s written description that would lead an artisan of ordinary skill to know that the inventor had invented a combination of those different pieces.”11 And Judge Connolly explained that the Federal Circuit has held that “pointing to an ‘amalgam of disclosures’ from which an artisan could have created the claimed invention does not satisfy” the written description requirement.12
Judge Connolly also explained that after CareDx introduced evidence that supports its written description position, it was Natera’s burden to produce evidence to rebut that position. But Natera did not produce any evidence beyond Dr. Quackenbush’s conclusory testimony. Because there was “no substantial evidence to support the jury’s finding of adequate written description,” Judge Connolly held that “judgment of invalidity of the asserted claims of the ’544 patent as a matter of law is warranted.”13
Likewise, Judge Connolly held that “[t]he ’180 patent’s written description… is inadequate as a matter of law for the same reason the ’544 patent’s written description is inadequate—i.e., Natera did not adduce at trial substantial evidence that the patent’s text shows that the inventor possessed the combination of the elements of the claimed methods.”14
3. Conclusion and Takeaways
In the competitive and litigious field of molecular genomics, where new applications (e.g., new computational approaches) for the underlying technology of high-throughput screening are being developed and patented, Judge Connolly’s decision suggests that placing all elements into a specification in piecing them together later may be insufficient. Instead, Judge Connolly’s decision underscores the importance of tying the individual components of an invention together in a patent specification, and that providing working examples of the inventions may be critical.
For patent litigators, Judge Connolly’s decision highlights several important points to be mindful of at trial. Judge Connolly held, consistent with Federal Circuit precedent, that if a patent broadly claims several components of an invention, the specification must disclose those elements “as an integrated whole” to satisfy the written description requirement. Pointing to disparate portions of the specification will not suffice if nothing is tying those elements together.
Judge Connolly’s opinion also underscores the importance of lawyers minding their burdens and ensuring that they have supported their arguments (including their expert’s testimony) with reliable evidence. This is especially true, and can be easy to overlook, where burdens shift from one party to the other, as was the case here.
Finally, this case shows that even after an adverse jury decision, it is still possible to prevail—but understanding how to proceed, and what issues to focus on, are critical. Here, CareDx chose to focus on a select number of issues in its motion rather than attempting to relitigate the full spectrum of issues the jury considered. In doing so, CareDx successfully invalidated the patents and avoided the $96 million in damages for which it was otherwise liable.
[1] Natera, Inc. v. CareDx, Inc., No. 20-38-CFC-CJB (D. Del.).
[2] Id., D.I. 460.
[3] Id., D.I. 558.
[4] https://labproducts.caredx.com/products/alloseq-cfdna
[5] Id.
[6] Natera asserted three claims of the ’544 patent (claims 21, 26, and 27) and two claims of the ’180 patent (claims 14 and 15) against CareDx.
[7] D.I. 558 at 8-9.
[8] Id. at 9.
[9] Id. at 10.
[10] Id. at 11 (quoting Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1336-37 (Fed. Cir. 2021)).
[11] Id.
[12] Id. (quoting Flash-Control, 2021 WL 2944592, at *3).
[13] Id. at 13.
[14] Id. at 14.