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New USPTO “Pre-Docketing Notice” Pilot Program Could Streamline Examination

Holly Kane — Mon, 01 Jun 2026 23:13:44 +0000

The USPTO announced a new pilot program that could streamline examination, improve examination efficiency, and help the USPTO use its examination resources more efficiently. The “Pre-Docketing Notice” pilot program also offers significant benefits to patent applicants, providing a timely opportunity to trim portfolios to save costs or align portfolios with current commercial objectives, which may have shifted in the ~~months~~ years since the patent application was filed.

The “Pre-Docketing Notice” Pilot Program

The USPTO’s current indicate the average time from an application’s filing date to the date of its first Office Action is about 22 months, but this pre-examination waiting period varies widely depending on the technology and examiner workloads. Although the USPTO recently restored its “first action estimator” functionality in Patent Center, an applicant has to proactively look up the estimated time to examination for each application, and I’ve seen estimates as long as 22 months. The “Pre-Docketing Notice” pilot program will give more timely notice to applicants that examination is going to commence soon, providing actionable information applicants can use to streamline the examination process to their benefit.

According to the , under this pilot program the USPTO will send what it calls “an informational ‘Pre-Docketing Notice’” in pending nonprovisional utility patent applications about three months before the application is expected to be docketed to an examiner for substantive examination. Applicants can leverage this warning that the long preexamination clock is about to run out in several ways, depending on the circumstances of the application at issue.

If the application is no longer of interest, the applicant can expressly abandon the application and possibly obtain a refund of certain fees if the conditions in 37 CFR 1.138(d) are satisfied. This makes this option much more attractive to applicants than the abandonment option under the PIER pilot program that does not support a refund.

The applicant can review the claims and, if warranted, file a preliminary amendment to make any desired changes, such as to conform the claims to those being pursued in other jurisdictions, revise the claim language in view of current examination guidance, or present claims to specific embodiments currently of most interest (e.g., if priorities have changed since the application was filed).
The applicant can review corresponding ex-U.S. cases, and if favorable patentability determinations have been received for desired claims, consider filing a request for examination under the program.

The applicant can confirm that an Information Disclosure Statement has been filed and that no additional information needs to be cited.
The applicant can confirm that the named inventorship is correct and confirm that executed inventor declarations have been filed.

The applicant can confirm that the applicant and assignee information is correct and confirm that an Assignment has been recorded.
The applicant can plan and budget for prosecution costs in the coming months.

Another difference from the PIER pilot program is that no response to the Pre-Docketing notice is required. According to the USPTO, “applications will proceed to examination in the normal course if no action is taken.”

Get Ready for the Snap

It may be off-season for a football analogy, but I think of the “Pre-Docketing Notice” as a warning that the play clock is winding down and the Examiner is about to snap the ball based on the current record. This is the applicant’s chance to make sure the right players are on the field and get their formation set, call an audible to put better claims into play — or walk off the field to pursue express abandonment and a refund.

The USPTO will evaluate “how providing applicants with advanced notification … impacts an applicant’s decision making, application inventory, and quality and efficiency of examination.” I’m interested to see how many applicants will take advantage of this opportunity to ensure they are starting the examination process in a strong position on the field.

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Flexibility Versus Indefiniteness: What It’s All About

Holly Kane — Wed, 06 May 2026 17:31:04 +0000

In , the Federal Circuit recognized the permissibility of using “about” to “avoid a strict numerical boundary” for a claimed parameter, but held the claims at issue invalid as indefinite under 35 U.S.C. § 112(b). The court’s analysis highlights that the flexibility of “about” comes with a risk of invalidity, especially when the scope of the claimed range cannot be ascertained from the specification and prosecution history with reasonable certainty.

The “About” Clauses At Issue

The patent at issue was U.S. Patent No. 10,912,321, directed to “Methods of using peracetic acid to treat poultry in a chill tank during processing.” The court considered claim 1, which recites in part (emphasis added):

1. A method of treating at least a portion of a poultry carcass with peracetic acid, said method comprising the steps of:

…

after the step of providing the peracetic acid-containing water, determining the pH of the peracetic acid-containing water, and altering the pH of the peracetic acid-containing water to a pH of about 7.6 to about 10 by adding an alkaline source;

…

after the step of placing at least the portion of the poultry carcass into the peracetic acid-containing water, determining the pH of the peracetic acid-containing water in the reservoir with at least the portion of the poultry carcass therein, and altering the pH of the peracetic acid-containing water to a pH of about 7.6 to about 10 by adding an alkaline source; and

….

The district court had found the “about” clauses to be indefinite. On appeal, the Federal Circuit agreed.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Lourie and joined by Judge Prost and District Judge Burroughs (sitting by designation).

The Federal Circuit applied the legal standard of definiteness set forth in the Supreme Court’s 2014 decision in Nautilus, Inc. v. Biosig Instruments, Inc.:

A claim is invalid for indefiniteness if its language, when read in light of the specification and the prosecution history, fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention.

Stepping through the intrinsic record (the claims, the specification, and the prosecution history), the Federal Circuit noted the following:

The claims did not provide any guidance on the scope of “about”.
Some of the examples reported in the specification indicated that “about” could mean ± 0.3 of a target pH, while others might support a broader scope, such as ± 0.35 or ± 0.5.
The prosecution history did not inform the scope of “about,” especially where some arguments did not even use the term “about” when discussing the claimed pH range. The Federal Circuit found that the Applicant’s arguments “treated the term inconsistently, suggesting that it was material to some claims and immaterial to others.”
The pH clause was amended to avoid prior art “which was as close as a pH of 7.0”

Summarizing its determination of invalidity, the opinion concludes:

When the specification recites pHs of 6–10, and the prior art pH of 7.0 required the claims to be amended, the definiteness requirement of § 112 necessitates much more clarity than using the vague term “about.” The prior art is almost “about” a pH of 7.6.

That last sentence strikes me as a finding of fact that begs for supporting expert testimony, even though Judge Lourie himself has a Ph.D. in chemistry.

What Was It All About?

The term “about” is used frequently in pharmaceutical patents where a degree of approximation often reflects reality more than strict numerical boundaries would, so I dug into the record to see what it really was all about. A few things struck me:

The specification did not contain a general “definition” or explanation of “about.”
The lower end of the recited pH range was pulled from specific examples, and was not expressly disclosed in the detailed description with an “about” modifier.
The recited pH value was not the sole basis for distinguishing the prior art reference cited for disclosing a pH of 7.
There were no parallel claims without the “about” modifier.

Regarding the Federal Circuit analysis, I was most struck by the court’s consideration of the precision with which the protocols of the examples were carried out. I appreciate that could inform how someone skilled in the art would have understood the recited pH values, but I wonder why the court decided that examples reflecting different magnitudes of variation from the target pH made “about” indefinite, rather than indicating flexibility up to the largest variation permitted.

Overall, this decision underscores that any flexibility in claim scope may carry a risk of invalidity for indefiniteness, even if precision in the parameter at issue is not critical to operability or patentability.

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USPTO to Take a Piercing Look at National Stage Applications

Holly Kane — Thu, 09 Apr 2026 21:11:42 +0000

The USPTO has announced a new pilot program applicable only to U.S. national stage applications that will require applicants to confirm they want to proceed before their applications are assigned to an examiner. Unlike other pilot programs, the USPTO (not the applicant) will decide which applications are subject to this requirement. The USPTO is hopeful the pilot program will reduce the inventory of applications to be examined and thereby improve examination efficiency for other applications. However, applicants may be concerned that it will delay examination of national stage applications, increase prosecution costs, and short-change patent term adjustment awards.

The PCT Informed Examination Request (PIER) Pilot Program

The new “PCT Informed Examination Request (PIER)” pilot program will implement a request for examination-like process in selected U.S. national stage applications (filed under 35 U.S.C. § 371), requiring applicants to “indicate, based on review of international phase work products present in the application file, whether the applicant opts to proceed with the national phase of examination, delay the national phase of examination for 12 months under the program, or expressly abandon the national stage application.” According to the , the USPTO will issue a Request for Information under 37 C.F.R. § 1.105. Applicants must use (new) form PTO/SB/478 to reply within an extendable, two month period.

Applicants who elect to proceed with examination are invited (but not required) to “place the application in better condition for examination by filing a preliminary amendment.”

Applicants who elect to abandon their applications are reminded that a proper reply electing abandonment must be signed by an authorized individual (e.g., having power of attorney in the application) or by the applicant (if not a juristic entity). On the other hand, the Notice warns that failure to timely file a properly signed reply will result in abandonment, so it appears that even an improperly signed reply electing abandonment will result in the application being abandoned.

No Impact on Search and Examination Fees

Applicants who opt to abandon applications under the PIER pilot program will not be entitled to a refund of search and examination fees. According to the Notice, this is because the Requirement for Information issued under the program is an action under 35 U.S.C. § 132.

The PIERcing Impact on Patent Term Adjustment

The PIER pilot program will have two key impacts on patent term adjustment (PTA):

First, the USPTO has decreed that a Request for Information issued under the program is “an Office action under 35 U.S.C. § 132,” which means it will stop the 14-month PTA clock running against the USPTO from the national stage commencement date. Typically, this clock is stopped by a paper issued by the examiner (such as an Office action with a restriction requirement, Office action on the merits, or Notice of Allowance), but applications pulled into this pilot program will not be assigned to an examiner until after a reply is filed. Although the USPTO should award PTA under 35 U.S.C. § 154(b)(1)(ii) if it takes more than four months to issue the next Office action after the reply is filed, applications will lose out on PTA that otherwise would have been awarded for the entire delay until an Office action issued by an examiner.

Second, if the applicant elects to delay examination for 12 months under the program, the USPTO will treat the 12 month period as a period of “applicant delay” under the PTA rules, with the delay period beginning on the date of receipt of the reply requesting to delay examination and ending one year later.

PIERcing Questions About PIER

I have a few questions about the PIER pilot program that are not answered by the Notice.

How will the USPTO select applications to include in the program?
How many applications will be selected?
Why is the USPTO targeting national stage applications in this program? Are national stage applications abandoned after the first Office action on the merits more frequently than other new applications?
Is it permissible for the USPTO to treat a Request for Information under the program an Office action under 35 U.S.C. § 132?
35 U.S.C. § 132 states (emphasis added):
Whenever, on examination, any claim for a patent is rejected, or any objection or requirement made, the Director shall notify the applicant thereof, stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application; and if after receiving such notice, the applicant persists in his claim for a patent, with or without amendment, the application shall be reexamined. ….
What incentives do applicants have to elect abandonment?

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Ex Parte PTAB Decisions Rein In Obviousness-Type Double Patenting Rejections

Holly Kane — Thu, 08 Jan 2026 17:44:00 +0000

The doctrine of obviousness-type double patenting (“OTDP”) is one of the most complicated aspects of U.S. patent law. Recent Federal Circuit decisions have addressed specific OTDP issues, but tension between competing objectives of this judge-made doctrine leave many open questions. Current USPTO leadership has not proposed new rules that would change how the Examining Corps applies the doctrine, but ex parte decisions by the USPTO Patent Trial and Appeal Board (PTAB) seem to reflect a willingness to hold examiners to the current state of the law.

OTDP Rejections Require a Reasoned Analysis

In Ex parte Mobile Tech, Inc., Appeal 2022-001034 (Reexamination Control 90/014,363) (decided Feb. 11, 2022), the PTAB reversed four OTDP rejections where the Examiner had not provided “an explanation … … to substantiate the Examiner’s conclusion” that the claims on appeal were obvious in view of the cited claims. The Office Action provided a claim chart aligning claim limitations, but did not address textual differences between the pending claims and the cited claims.

In reversing the rejections, the PTAB explained:

[W]here, as here, the Examiner’s rejection fails to (1) articulate any analysis apart from merely quoting the language of the relied-upon claims; (2) acknowledge the differences in that language; and (3) explain why those differences would have been obvious to ordinarily skilled artisans, the Examiner has not established non-statutory double patenting on this record. The rejection is, therefore, erroneous for that reason alone.

Later-Filed, Later-Expiring Patents Are Not Proper OTDP References

In Ex parte Baurin, Appeal 2024-002920, (Application No. 17/135,529) (decided Nov. 11, 2024) (reh’g denied Dec. 18, 2025), the PTAB reversed five OTDP rejections that cited later-filed, later-expiring patents as OTDP references and reversed a provisional OTDP rejection over a later-filed pending application with a later patent term filing date, finding that the later-expiring patents/application were not proper OTDP references.

The PTAB cited the Federal Circuit decision in Allergan USA, Inc. v. MSN Labs. Private LTD., 111 F.4th 1358 (Fed. Cir. 2024), for the principal that the purpose of OTDP doctrine “‘is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter.’” The PTAB also considered the Federal Circuit decisions in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), and Abbvie v. Mathilda & Terrence Kennedy Institute, 764 F. 3d 1366 (Fed. Cir. 2014), and noted that in both cases the cited claims had an earlier filing date and earlier expiration date than the claims at issue. In contrast, the rejections on appeal relied on patents granted from later-filed applications with later expiration dates. Because they did not fit the Allergan paradigm, the rejections were reversed.

In a rare turn of events, the examiner filed a Request for Rehearing, arguing:

(1) the Board’s decision misapprehends the holding of Allergan;

(2) the Board’s decision is not consistent with USPTO guidance set forth in MPEP §§ 804 and 804.02; and

(3) the Board’s conclusion that the risk of separate ownership is “immaterial” … is not supported by case law or USPTO guidance.

A reconstituted PTAB panel denied the request for rehearing in a 2-1 decision, with the new panel member dissenting. As to point (1), the majority stood by its application of Allergan and rejected the Examiner’s attempts to limit it to its facts. As to point (2), the majority disagreed in some respects and emphasized that the MPEP “cannot create new law or ignore the law.” As to point (3), the majority found that the risk of separate ownership does not justify an OTDP rejection based on an improper reference patent.

Precedential Decisions Would Provide Clear Guidance

While these decisions are not precedential, I understand the PTAB Bar Association has asked Director Squires to designate both as precedential. Doing so would provide clear guidance to applicants and examiners, and promote consistency in examination of applications under this complex doctrine. In the meantime, Applicants faced with improper OTDP rejections can point to these decisions as informative, and consider appealing maintained rejections to the PTAB.

Attorneys at �鶹��ý have extensive experience counseling clients on OTDP issues in their own and competitor patent portfolios. Contact the author or your �鶹��ý attorney for more information.

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Seeking Grace: Pursuing Method of Treatment Claims in View of Clinical Trial Related Disclosures

Cara Mosley — Tue, 02 Dec 2025 19:23:09 +0000

This article was originally published in the AIPLA Chemical Practice Chronicles Fall 2025 newsletter and is republished here with permission.

I. Background

Method of treatment patents based on Phase II and Phase III clinical trial protocols are routinely pursued to extend patent exclusivity and strategically build a patent portfolio for a drug asset. The claims of these “later-generation” method of treatment patents recite salient features of the Phase II or Phase III clinical trial protocol including patient populations, dosage amounts, dosing regimens, and efficacy outcome measurements. This is done for good reason, as the salient features of the study protocol often appear on the drug label, sometimes as part of explicit active steps.

For a new chemical entity (NCE), a later-generation method of treatment patent provides additional patent term, sometimes years beyond the patent term of the earlier-generation patents, i.e., foundational patents providing composition of matter and/or broad method of treatment exclusivity.

For repurposed drugs or novel dosing protocols, method of treatment patents based on Phase II or Phase III clinical trial study protocols may provide the only meaningful source of patent exclusivity, e.g., if the compound is known and the composition of matter patent has expired or is soon to expire.

Conventional wisdom dictates filing a patent application based on a Phase II or Phase III clinical trial protocol prior to a public disclosure of the study to avoid creation of prior art that can preclude patentability of the method of treatment claims, particularly outside the U.S.^[1] Given the strategic importance of later-generation method of treatment patents, care should be taken to understand the timing of any public disclosures relating to the clinical trial and to plan patent application filings accordingly.

One such clinical trial related public disclosure is the posting of the innovator’s clinical trial protocol to ClinicalTrials.gov (“CTG”) as a so-called “study record.”^[2] Posting of the study record is part of the U.S.’s well-intentioned effort to conduct human clinical trials with transparency to, inter alia, build public trust in clinical research and help patients find trials for which they might be eligible to participate. Innovators are to submit clinical trial study protocols to FDA no later than 21 days after the first patient is enrolled in the trial^[3], and the study record will be posted not later than 30 days after submission^[4]^[5]. Given these deadlines, it is typically not possible to predict the exact day a study record becomes public on CTG. Such an “un-docketable” deadline, unlike the firm date of an expected journal article publication or public symposium, has – perhaps unsurprisingly – led to a fact pattern where a study record is posted to CTG before a corresponding method of treatment patent application is filed.

II. Use of the § 102(b)(1)(A) exception

Clinical trials themselves are not considered a prior public use under 35 U.S.C. § 102(a)(1).^[6] CTG study records and other clinical trial related disclosures, however, are considered printed publications and/or “otherwise available to the public” under §§ 102(a)(1) if made before the effective filing date of the patent application. Such clinical trial related disclosures can therefore be used to reject a later-filed patent application’s method of treatment claims as anticipated under 35 U.S.C. § 102(a)(1) and/or obvious under 35 U.S.C. § 103.

In the event a CTG study record or related disclosure becomes publicly available prior to filing a corresponding U.S. method of treatment patent application, the grace period exception under § 102(b)(1)(A) may be invoked to disqualify the disclosure under § 102(a)(1) – provided the disclosure is made one year or less before the effective filing date of the application. Procedurally, should an Examiner make a rejection under 35 U.S.C. §§ 102(a)(1) and/or 103 based on a CTG study record or related disclosure, Applicant can invoke the grace period by submitting a declaration under 37 CFR § 1.130 (“Rule 130”) establishing that the disclosure was made by the inventor or joint inventors and requesting removal of the CTG study record or related disclosure as prior art.

While submission of the Rule 130 declaration seems straightforward, a recent PTAB example, Murray & Poole Enterprises Ltd. v. Institut de Cardiologie de Montreal^[7] is illustrative of potential traps. Institut de Cardiologie de Montreal (ICM) attempted to remove “Bouabdallaoui” as prior art by invoking the grace period exception under § 102(b)(1)(A). Bouabdallaoui was published within the one-year grace period and expanded on the results of the “COLCOT” CTG study record. Bouabdallaoui listed seven authors, the second of whom, Dr. Tardif, was the sole inventor on ICM’s patent. The board articulated that invocation of the grace period hinged on whether the declaration of Dr. Tardif provided sufficient information to conclude that Bouabdallaoui was not “by another.”^[8] Dr. Tardif’s declaration explained the working relationship with only one co-author (Bouabdallaoui), as inter alia, acknowledgement of Bouabdallaoui’s assistance in conducting the clinical trial and to provide a first author publication. Dr. Tardif’s declaration also described the scope of the COLCOT multi-center clinical trial and ICM’s status as the sponsor, supported by agreements between some of the centers and the sponsor. The board pointed out that only a subset of center-sponsor agreements was provided and, among the agreements provided, none listed Dr. Tardif as the principal investigator.^[9] Ultimately, in its decision of institution, the board found that Dr. Tardif’s declaration was insufficient to disqualify Bouabdallaoui as prior art.^[10]

As Murray demonstrates, all differences between the authors of the clinical trial related disclosure and inventors on the patent application should be thoroughly explained. Declarations from any superfluous authors, i.e., non-inventors, disclaiming their contribution to the subject matter relied on in making the prior art rejection may help establish that the clinical trial related disclosure is not “by another.” CTG study records, unlike typical publications, list only the sponsor of a clinical trial, not specific individuals responsible for designing the study. Nonetheless, the inventor(s) can attest to the CTG study record as their own work in a declaration. Supporting documentation clearly tying the inventor(s) to the CTG study record, e.g., by naming the inventor(s) as the principal investigator(s), can also be provided.

III. International grace period provisions and filing strategies

In addition to the U.S., several foreign jurisdictions also provide a grace period. While not exhaustive, Table 1 summarizes grace period availability in commonly filed foreign jurisdictions, application filing timing, and whether proactive steps should be taken to make use of the grace period. Practitioners should work closely with local counsel to understand nuanced national requirements and timing to properly rely on each country’s available grace period.

Table 1

Country	Grace Period Available	Time to file application (from disclosure)	Type of first application that should be filed	Can the first application serve as priority document…^†	Notes
AU	Yes	12 months	AU Standard Application or PCT	Yes (for PCT)	No proactive steps required.
BR	Yes	12 months	U.S. Provisional, BR, or PCT	Yes	No proactive steps required.
CA	Yes	12 months	CA or PCT	No	No proactive steps required.
CN	No	—	—		CTG disclosure does not qualify for the grace period.
EP	No	—	—		CTG disclosure does not qualify for the grace period.
JP	Yes	12 months	JP or PCT	No	Within 30 days of filing the JP national application or JP national phase entry, a certificate must be filed describing several features of the public disclosure.
KR	Yes	12 months	KR or PCT	Yes, but only if priority filing is (a) a PCT application designating only KR or (b) a direct KR application	Evidentiary documents must be submitted proving the applicant/inventor’s disclosure and showing (i) the date and type of the disclosure, (ii) the disclosing party, and (iii) the content of the disclosure.
MX	Yes	12 months	U.S. Provisional, MX, or PCT	Yes	The date of the public disclosure must be included on a form when filing the MX national application or MX national phase entry of the PCT.
PH	Yes	12 months	U.S. Provisional, PH, or PCT	Yes	No proactive steps required.
SG	Yes	12 months	PCT	No	No proactive steps required.
TW	Yes	12 months	TW	No	No proactive steps required.
U.S.	Yes	12 months	U.S. Provisional or PCT	Yes	No proactive steps required.

† for a PCT or other application filed after the grace period that benefits from the grace period?

Like the U.S., Australia, Brazil, Canada, Japan, Mexico, the Philippines, South Korea, Singapore, and Taiwan all provide grace periods for CTG study records and related disclosures within 12 months of a first patent application’s filing date. They differ, however, with respect to whether the first patent application can serve as a priority document to a later-filed application, e.g., a PCT application, where the national stage application of the PCT application will also be eligible to benefit from the grace period. Certain jurisdictions, e.g., China and Europe, effectively do not have grace periods applicable to CTG study records or related disclosures.

In view of these distinctions, one can envisage complex potential filing strategies depending on international filing priorities.

Scenario 1 is a “typical” filing strategy where a U.S. provisional application is the first-filed application in the family. This filing strategy can be followed to pursue patent coverage in countries where a U.S. provisional application filed within 12 months of the CTG study record or related disclosure can serve as a priority document to a PCT application filed 12 months after the U.S. provisional application, and the national phase applications of the PCT application are eligible to benefit from the grace period based on the U.S. provisional application’s filing date. Representative countries in which this filing strategy can be utilized include the U.S., Brazil, Mexico, and the Philippines.

Filing Scenario 1

Scenario 1 can also be followed in countries that actually or effectively lack grace periods (e.g., China and Europe). To overcome the absolute novelty bar in China, possible aspects of the planned commercial methods that are not disclosed in the clinical trial related disclosure can be included in the U.S. provisional and/or PCT application. In Europe, CTG study records or announcements regarding ongoing trials not considered to be novelty destroying, although they can be used in an inventive step analysis.^[11] For guidance on the implications of clinical trials as prior art in Europe, we direct the reader to the Spring 2024 AIPLA Chemical Practice Committee’s informative article on this very topic.^[12]

Scenario 2 can be followed in countries where a PCT or non-PCT country national application must be filed within one year of the public disclosure for the national application to be eligible to benefit from a grace period. Representative countries in which this strategy can be utilized include Australia, Canada, Japan, Korea, Singapore, and Taiwan.

Filing Scenario 2

Scenario 1 provides two potential advantages compared to (a) a more conservative filing strategy where the U.S. provisional application is filed prior to the CTG study record posting and (b) Scenario 2: (1) maximum time for generating clinical trial results which, if available, can be included in the PCT application, and (2) the potential for maximum patent term.

Scenario 2 does not offer the benefit of an extended duration between CTG study record posting and national or PCT application filing. As such, results of the clinical trial are generally less likely to be available by the time a PCT application or non-PCT country national application is filed. However, many of the above-mentioned countries permit post-filing data during prosecution by which clinical trial results can be presented.^[13]

Scenario 3 combines Scenario 1 and Scenario 2 into a unified filing strategy. First, a U.S. provisional application (following Scenario 1), a first PCT application (PCT1) (following Scenario 2), and non-PCT country national application(s) (following Scenario 2) are filed on the same day and within one year of the CTG study record posting. Prior to filing any applications outside the U.S., a foreign filing license should be considered and, if necessary, obtained. PCT1 can be nationalized in the jurisdictions with stricter grace period requirements outlined above for Scenario 2.

Filing Scenario 3

A second PCT application (PCT2) claiming priority to the U.S. provisional application can then be filed on the 12-month Convention date for the U.S. provisional application that includes the results of the clinical trial, if available. PCT2 can be nationalized in the jurisdictions with more relaxed grace period requirements as outlined above for Scenario 1.

This bespoke approach maximizes the potential benefits of grace periods, where available, while accounting for inclusion of clinical trial results data (either in PCT2 or as post-filing data during national stage application prosecution). The result is improved chances of obtaining method of treatment coverage and longer patent term.

IV. Conclusion

CTG posting of a Phase II or Phase III study record or a related public disclosure does not inevitably preclude patentability of method of treatment claims in a later-filed patent application based on the clinical trial protocol. A surprising number of jurisdictions provide grace periods by which a CTG study record or related disclosure can be removed as prior art if a patent application is filed within one year of the disclosure. However, the type of patent application that must be filed within one year varies by jurisdiction, thereby leading to complex filing strategies. In the U.S., to exclude CTG study records using the § 102(b)(1)(A) exception, practitioners should carefully draft Rule 130 declarations that unambiguously tie the inventor(s) of the patent application to the sponsor and principal investigator(s) of the clinical trial. Similarly, Rule 130 declarations to exclude clinical trial related disclosures using the § 102(b)(1)(A) exception should unambiguously explain any and all differences between the author(s) of the disclosure and the inventor(s) of the claimed subject matter.

[1] Most ex-US jurisdictions do not permit “method of treatment” claims per se, although such claims can be reformulated in accordance with local practice, e.g., as Swiss-type claims and/or purpose-limited compounds for use-type claims.

[2] 42 U.S.C. § 282(j)(2)(A)

[3] 42 U.S.C. § 282(j)(2)(C)

[4] 42 U.S.C. § 282(j)(2)(D)

[5] Changes to the clinical trial, including changes to the protocol, are also posted to CTG by the same mechanism such that multiple study records are typically available on CTG for a given clinical trial.

[6] See, e.g., Sanofi v. Glenmark Pharms, Inc., USA, 204 F. Supp. 3d 665 (D. Del. 2016), aff’d sub nom., Sanofi v. Watson Lab’ys Inc., 875 F.3d 636 (Fed. Cir. 2017) (A patent on a method of using dronedarone in treating patients was not ready for patenting before the critical date and thus not a public use); In Re Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008) (A Phase III clinical trial was not a public use because the invention had not been reduced to practice and therefore was not ready for patenting).

[7] IPR2023-01064, Paper 9 (P.T.A.B., Jan. 16, 2024).

[8] Id., page 54.

[9] Id., page 55.

[10] Id., page 56.

[11] T 158/96, T 715/03, T 1859/08 and T 2506/12

[12] Dr. Holger Tostmann, Newsletter of the AIPLA Chemical Practice Committee, Spring 2024, Volume 12, Issue I, p. 24.

[13] In Canada, utility is established by demonstration or “sound prediction” at the time the application is filed.

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Act Fast For (Nearly) Free Expedited Examination

Courtenay Brinckerhoff — Fri, 24 Oct 2025 20:02:39 +0000

The USPTO announced a new pilot program designed to help it efficiently reduce the backlog of unexamined patent applications. The “Streamlined Claim Set Pilot Program” has an attractive incentive for participation—the promise of expedited examination for a low petition fee if other requirements are met. The pilot program will run for 12 months or until “at least approximately 200 applications” have been accepted into each Technology Center that examines utility applications, whichever occurs first. Interested applicants may want to act fast because this pilot program could be popular.

Streamlined Claim Set Pilot Program Requirements

Savvy stakeholders will guess from its name that the pilot program requires a “streamlined” claim set. That is the one requirement you can amend your application to meet. The others must already be met as of the October 27, 2025, publication date of the

The application have an actual filing date before October 27, 2025
The application must be an original, noncontinuing, utility application filed under 35 U.S.C. § 111(a)—continuations, divisionals, CIPs, and national stage applications need not apply
The application must not yet be docketed to an examiner
The application must contain—or be amended to contain—only one independent claim, up to ten total claims, no multiply dependent claims, and the dependent claims must conform to a specific format outlined in the Federal Register Notice
Any non-publication request must be rescinded
No inventor or joint inventor is named on more than three other applications for which participation in the pilot program has been sought

Applicants wanting to participate must file a “petition to make special” (using a new USPTO form) and pay the petition fee of 37 C.F.R. § 1.17(h), which is only $150 for a Large Entity. The petition must be filed before any action by an examiner (e.g., Office Action on the merits or Restriction Requirement). Indeed, “the USPTO will … generally dismiss a petition under the pilot program if the application has already been docketed to a particular examiner.”

Examination of Streamlined Pilot Program Applications

As explained in the Federal Register Notice, applications accepted into the Streamlined Claim Set Pilot Program will be accorded “special” (expedited) status only until the first Office Action is issued. However, the program’s “streamlined claim set” requirements remain in effect throughout the examination process.

The Federal Register Notice explains that this pilot program is “designed to allow the USPTO to evaluate how having a limited number of claims under examination affects pendency and examination quality.” The Notice does not explain how “examination quality” will be assessed, but states that it will “provide avenues for participants to provide feedback on their experience with the pilot program.”

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Will You Help The USPTO Test AI-Generated Prior Art Searching?

Courtenay Brinckerhoff — Thu, 09 Oct 2025 16:22:11 +0000

One of the goals of the new Director of the United States Patent and Trademark Office (USPTO) is to improve patent examination efficiency by leveraging Artificial Intelligence (AI) tools. The Automated Search Pilot Program announced in a published October 8, 2025, asks patent applicants to volunteer their applications to help the USPTO assess the impact and feasibility of using AI tools to generate initial prior art search results. Participation does require a fee, but applicants may be willing to participate in order to help the USPTO assess the potential value of AI-generated search results and determine if they might improve examination efficiency and quality.

Program Goals

According to the Notice, the goal of the Automated Search Pilot Program is “to evaluate the impact of sharing the results of an automated search” with applicants prior to examination, as well as to assess the scalability of generating automated search results. The USPTO contemplates that providing “automated search results” to an applicant early in the examination process “will provide the applicant with an earlier communication regarding potential prior art issues in their application,” and offer an opportunity to “place the application in better condition for examination” before it is reviewed by the examiner. The USPTO also expects the automated search to “provide[] a new pathway to identify relevant prior art for patent examiners to improve examination quality and efficiency.”

Participating In The Pilot Program

The Automated Search Pilot Program will begin October 20, 2025, and will only be open to brand new utility patent applications:

Only original, noncontinuing, nonprovisional utility applications filed under 35 U.S.C. 111(a) on or after October 20, 2025, and on or before April 20, 2026, are eligible to participate in the pilot program.

Thus, the following applications will not be included: international applications that have entered the national stage under 35 U.S.C. 371; plant applications; design applications; and reissue applications.

In addition, continuing (i.e., continuation, divisional, or continuation-in-part) applications will not be included.

To participate in the program, applicants must file a petition using a new form (Form PTO/SB/470, titled “CERTIFICATION AND PETITION UNDER 37 CFR 1.182 TO PARTICIPATE IN THE AUTOMATED SEARCH PILOT PROGRAM” and pay the petition fee set forth in 37 CFR 1.17(f) (currently $450 for a large entity or $180 for a small entity).

As explained in the Notice, the petition must be filed with the application papers (at the time the application is filed), but will not be decided until the application has completed pre-examination processing. Due to the short timeframe of the program, applicants will not be given an opportunity to correct any defects that led to denial of a petition to participate.

The Federal Notice sets forth additional participation requirements that and should be consulted before any petition is filed.

The Automated Search

As explained in the Notice, “[t]he automated search will be conducted using an internal Artificial Intelligence (AI) tool” that uses the CPC classification of the application, specification, claims, and abstract as contextual information. The Notice explains further:

The AI tool will use the contextual information to find similar information in publicly available documents located in a number of databases available to the USPTO, including U.S. Patents, U.S. Pre-Grant Publications (PG-Pubs), and Foreign Image and Text (FIT). The FIT database includes publications from a number of foreign patent authorities. The AI tool will rank the returned documents from most to least relevant.

The Notice provides the following additional information on the AI tool and confidentiality:

The AI models supporting the automated search are trained using publicly available patent data, including text of patents and published applications, patent classifications, document citations, and human-rated similarity. The training data excludes applicant, inventor, and assignee information because this information may introduce potential biases in the model. The USPTO has implemented measures for the AI tool to ensure data security and maintain patent application confidentiality as required by 35 U.S.C. 122(a). See New Artificial Intelligence Functionality in PE2E Search, 1504 OG 359 (November 15, 2022).

The Automated Search Results Notice (ASRN)

According to the Notice, the results of the automated search will be the generation of an ASRN that will be sent to the applicant and placed in the application file. Importantly, applicants are not required to respond to the ASRN, but may elect to do so as outlined below. The ASRN will list up to 10 documents returned by the AI tool, “listed in descending order of relevance as determined by the AI tool.” According to the Notice, “[c]opies of the documents cited in the ASRN will not be placed in the file”— applicants will have to obtain copies themselves.

Putting The ASRN To Use

As noted above, applicants are not required to respond to the ASRN, but the USPTO hopes they will do so (when appropriate), such as by:

filing a preliminary amendment
filing a petition for express abandonment under 37 CFR 1.138(d) and requesting a refund of the search fee and any excess claims fees
filing a request for deferral of examination under 37 CFR 1.103(d)

Any of these actions must be pursued promptly, before the examiner commences examination—no specific time period to take action is guaranteed.

According to the Notice, examiners will consider the ASRN documents as they would their own search results, and will not be required to list ASRN documents on Form PTO-892 unless relied upon in a prior art rejection.

While applicants are not required to cite the ASRN documents in an Information Disclosure Statement (why would they be???), the ASRN documents only will be listed on the face of the patent if formally made of record by the examiner on a Form PTO-892 or cited by the applicant in an Information Disclosure Statement. (Yes, the USPTO has found a way to increase the already-high IDS burden!)

Evaluating The Pilot Program

As noted above, the primary goal of the pilot program is “to evaluate the impact of sharing the results of an automated search prior to examination of a patent application.” According to the Notice, the USPTO will specifically evaluate the scalability of generating and mailing the ASRN and the usefulness of the ASRN to applicants. In that regard, “the USPTO anticipates providing an avenue for participants to provide feedback regarding the pilot program.”

Promoting Applicant Participation

The success of the Automated Search Pilot Program will depend on applicant participation. It is too bad participation requires a fee, but applicants may be willing to test it out in order to receive prior art search results earlier in the process, and help the USPTO take this step towards implementing AI-assisted prior art searching.

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Federal Circuit Skeptical of Prosecution Laches

Courtenay Brinckerhoff — Thu, 04 Sep 2025 17:20:39 +0000

In , the Federal Circuit soundly disposed of arguments that the patent-in-suit was unenforceable due to laches based on an “unreasonable delay” in patent prosecution. Does the court’s reasoning foreclose the prosecution laches defense for any later-claimed invention disclosed in a published parent application? Is there merit to Judge Alsop’s concerns that unlimited continuation practice can inhibit competition and disrupt the careful balance struck between promoting and protecting innovation?

The District Court Decision

Judge Alsup’s Order on prosecution laches did not mince words:

The essence of this order is that the patents issued after an unreasonable, inexcusable, and prejudicial delay of over thirteen years by the patent holder, Sonos, Inc. Sonos filed the provisional application from which the patents in suit claim priority in 2006, but it did not file the applications for these patents and present the asserted claims for examination until 2019. By the time these patents issued in 2019 and 2020, the industry had already marched on and put the claimed invention into practice.

To the extent the Order accepted that “Sonos diligently prosecuted [the parent] applications,” it still questioned why Sonos had not filed “parallel applications with new claims covering the invention” in the meantime. The Order found that Google was prejudiced by the delay, because “Google began investing in the accused products by at least 2015, when it released its first products that practiced the invention.” As stated in the Order, “There is no question that Google worked on, invested in, and used the claimed technology during the period of Sonos’s delay.”

The Order concluded:

It is wrong that our patent system was used in this way. With its constitutional underpinnings, this system is intended to promote and protect innovation. Here, by contrast, it was used to punish an innovator and to enrich a pretender by delay and sleight of hand. It has taken a full trial to learn this sad fact, but, at long last, a measure of justice is done.

In sum, under, under the doctrine of prosecution laches, the patents in suit are UNENFORCEABLE. ….

The Federal Court Opinion

The Federal Circuit opinion was authored by Judge Lourie and joined by Judge Prost and Judge Bumb, Chief Judge, United States District Court for the District of New Jersey, sitting by designation.

The Federal Circuit explained that the doctrine of laches “may render a patent unenforceable when it has issued only after an unreasonable and unexplained delay in prosecution that constitutes an egregious misuse of the statutory patent system under the totality of the circumstances.” The defense of laches requires proof on two points:

that the delay in prosecution was “unreasonable and inexcusable under the totality of circumstances” and
that the defendant “suffered prejudice attributable to that delay.”

The opinion focused on the second point, and found it lacking:

[N]o reasonable factfinder could conclude that the specification—which was published in 2013, before any of Google’s asserted investments—does not reasonably disclose over-lapping zone scenes. Google cannot be prejudiced by incorporating into its products a feature that was publicly disclosed in a patent application prior to its investment.

In support of its ruling, the Federal Circuit cited cases the district court had attempted to distinguish:

“[I]t is not improper for an applicant to broaden his claims during prosecution in order to encompass a competitor’s products, as long as the disclosure supports the broadened claims.” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 909 (Fed. Cir. 2004)

“[A]lthough subject matter disclosed but not claimed is generally dedicated to the public, there is an exception for subject matter “claimed in a continuation or other application.” Eli Lilly & Co. v. Hospira, Inc., 933 F.3d 1320, 1334 (Fed. Cir. 2019)

The Federal Circuit concluded that Google had “present[ed] no evidence that it suffered prejudice attributable to Sonos’s delay in claiming, but not disclosing, overlapping zone scenes,” and, therefore, that the district court’s finding of unenforceability was an abuse of discretion.

Is Prosecution Laches Still A Viable Defense

Patent stakeholders who found the harsh language of Judge Alsop’s Order chilling may be relieved by the Federal Circuit decision. I found it interesting that the court did not delve into the course of prosecution, but instead rested its decision on lack of prejudice. Given the court’s ruling, could a defendant ever establish prosecution laches? Does the court’s rationale disrupt the balance of the patent system in favor of applicants who can afford to maintain continuation applications pending?

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Patent Fees Reimagined: Evaluating the Trump Administration’s Value-Driven Fee Structure and Its Impact on Innovators

bklemm@foley.com — Thu, 31 Jul 2025 17:53:10 +0000

Introduction: A Radical Shift in IP Policy

The the Trump administration wants to charge patent holders 1% to 5% of their patent’s value to maintain the patent after grant. If implemented, this would mark a dramatic departure from the traditional flat-fee model. Framed as a revenue-raising measure, the plan would drastically reshape the U.S. innovation landscape.

Potential Impacts on Innovators

Small innovators would be disproportionately affected by the newly proposed fees. Smaller entities often rely on the patent system to protect their inventions but lack the financial resources to absorb significant cost increases. As a result of these fee changes, many smaller companies may opt to use other avenues to protect their innovations, such trade secrets, or may forego investing in IP protection altogether.

Depending on how the value of patents is assessed, larger tech firms, while more capable of absorbing the costs, could respond by filing fewer but more strategically valuable patent applications. This could reduce the prevalence of ‘defensive’ filings and low-value patents, potentially streamlining the system.

Specifically in the biotech and pharmaceuticals spaces, patent protection is critical due to high risks and long timelines associated with product development. The proposed fees could significantly raise the already substantial costs of bringing new products to market. Small biotech firms may find it difficult to protect or license their breakthroughs, potentially leading to reduced investment at early development stages. Medical device manufacturers face similar pressures, where the cost-benefit balance of patenting may shift unfavorably.

The proposal could also result in industry consolidation, more strategic partnerships, or a shift toward trade secrets—developments that may hinder open innovation and collaboration. The net effect could be a leaner patent landscape focused on higher-quality applications and a reduction in “patent thickets,” but potentially at the cost of accessibility and innovation diversity.

How Companies Might Adapt

If the proposal moves forward, companies may explore various strategies to mitigate the impact of the new fees. One likely response is increased reliance on trade secrets, especially for software and process innovations that are easier to keep confidential.

Firms may also shift their patenting focus to international jurisdictions with more predictable or affordable IP regimes. Open innovation models, such as defensive publishing or open-source licensing, could gain popularity as a way to prevent competitors from patenting similar inventions.

Patent pooling and consortia may become more common, allowing companies to share the costs of filing and maintaining patents. Additionally, provisional filings could be used more strategically to delay full applications and manage financial risk.

Broader Implications

The proposed fee structure raises broader concerns about equity and U.S. competitiveness. Higher fees could exacerbate the divide between well-funded incumbents and new entrants, encouraging market concentration and likely reducing diversity in innovation.

The new fees would almost certainly reduce the overall number of filings. There is a strong argument that reduced filings would result in higher-quality patents. While fewer filings might improve patent quality, the cost barrier could prevent disruptive but underfunded ideas from reaching the market. Fewer patents would also raise the stakes of patent disputes.

On the global stage, the U.S. could lose its competitive edge if innovators relocate R&D to countries with more accessible IP protections. Moreover, tying fees to patent value introduces significant uncertainty, as valuation is inherently subjective and prone to dispute.

Of course, the implications of the impact of the proposed fee structure depends greatly on how the valuation is calculated and how it is applied to the patents. Does each individual patent get charged a percentage of revenue of a patented method, system, or product even though the system or product may be protected by dozens or hundreds of patents? Or does the percentage fee get distributed over all the patents attributable to the patented method, system, or product? There could be a scenario in which it is actually better for companies to get more patents to reduce the fees if the percentage is applied across an entire patent portfolio. For example, if a bicycle company makes $1M from sales of an innovative bicycle and there are 1,000 patents on the bicycle and the fee is 1% of revenue distributed over the total number of patents, the fees per patent are $10 and $10,000 for the portfolio of 1,000 patents. Given this example reduces the revenue to the government, it is unlikely to be applied in this manner; however, implementation details for the proposal are missing and whatever the details become, patent owners will find ways to reduce what they are to pay.

Potential Legal Challenges to the Proposal

The proposed fee changes are likely to face significant legal challenges. Under 35 U.S.C. § 41, Congress, not the executive branch, has the authority to set patent fees. Historically, courts have deferred to the USPTO on fee-setting when changes are modest and tied to cost recovery. However, a sweeping, revenue-driven increase could be struck down or stayed unless Congress explicitly authorizes it. Any attempt to implement such a change unilaterally would certainly be contested in court, with challengers likely arguing that a drastic fee hike oversteps executive authority.

Additionally, the Administrative Procedure Act (APA) requires that regulatory changes undergo a notice-and-comment rulemaking process. Failure to comply with this process could result in successful legal challenges. There may also be constitutional concerns. If the fees are prohibitive, small businesses could argue that the fees violate Due Process or Equal Protection clauses, although such claims may be difficult to win.

In sum, the Trump Administration proposal is fraught with questions and uncertainty. Congress and the courts should work to ensure that whatever the proposal is, it is thoroughly vetted and implemented by the correct branch of government.

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Jepson Claim Format Does Not Avoid Written Description Scrutiny

bklemm@foley.com — Mon, 07 Apr 2025 17:50:43 +0000

Current written description jurisprudence can make it difficult to obtain broad antibody patents, leading practitioners to explore alternative claiming strategies in an effort to bypass the limited scope afforded under the structure-function paradigm. Xencor pursued a so-called Jepson claim and argued that the portion of the claim reciting an antibody did not have to satisfy the written description requirement of 35 U.S.C. § 112. However, both the USPTO and blocked this attempt to make an end-run around the statute. Xencor also pursued a means-plus-function claim, but because it was invalidated on a different basis it remains to be seen how the court will treat means-plus-function antibody clauses.

What Is A Jepson Claim?

Jepson claims have a specific format provided for and defined in 37 CFR § 1.75(e):

Where 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 known,

(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.

As this language highlights, a Jepson claim has a specific format: (i) a preamble that identifies conventional/known features of the claimed subject matter; (ii) a specific transitional phrase, and (iii) a recitation of the “new or improved” aspects of the claimed subject matter.

Xencor’s Jepson Claim

As summarized in the Federal Circuit decision, the Xencor patent application at issue related to modified antibodies with certain amino acid substitutions that prolong half-life in vivo and “reduce[] the need for more frequent treatment.” The Jepson claim at issue recited specific mutations made in an “anti-C5 antibody”:

8. In a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising

said Fc domain comprising amino acid substitutions M428L/N434S as compared to a human Fc polypeptide,

wherein numbering is according to the EU index of Kabat,

wherein said anti-C5 antibody with said amino acid substitutions has increased in vivo half-life as compared to said antibody without said substitutions.

Does a Jepson Preamble Require Written Description Support?

The written description question surrounding Xencor’s Jepson claim focused on whether the written description requirement even applied to the “anti-C5 antibody” recited in the preamble. In particular, Xencor argued that “because the ‘invention’ in a Jepson claim is the improvement, it needed only to have written description for that improvement—here, everything other than the preamble.” Not surprisingly, the USPTO’s position was that “Jepson claim preambles are part of the invention and, therefore, require written description.”

The Federal Circuit opinion was written by District Judge Schroeder of the United States District Court for the Eastern District of Texas (sitting by designation) and joined by Judges Hughes and Stark. The Federal Circuit agreed with the USPTO that “a Jepson claim preamble requires written description.” After citing case law supporting this interpretation, the opinion explained:

The invention [of a Jepson claim] is not only the claimed improvement, but the claimed improvement as applied to the prior art, so the inventor must provide written description sufficient to show possession of the claimed improvement to what was known in the prior art.

While a Jepson claim is directed to the improvement it makes to the prior art, 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.

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.

The Federal Circuit also agreed with the USPTO determination that the written description requirement was not satisfied:

The specification only disclosed one anti-C5 antibody, 5G1.1, which the [USPTO] found was insufficient given the “various specificities and epitopes” of the genus. [Additionally,] Xencor had not demonstrated that anti-C5 antibodies were well-known and did not require further support in the specification.

According to the opinion, Xencor’s appeal did not challenge these determinations on the merits, choosing instead to rest on its legal arguments.

What About Means-Plus-Function Claiming?

Another alternative claim format is means-plus-function claiming, which is provided for and defined in 35 USC § 112(f).

An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

Xencor’s application included a claim that recited the antibody using means-plus-function language:

9. A method of treating a patient by administering an anti-C5 antibody comprising:

a) means for binding human C5 protein; and

b) an Fc domain comprising amino acid substitutions M428L/N434S as compared to a human Fc polypeptide,

wherein numbering is according to the EU index of Kabat,

wherein said anti-C5 antibody with said amino acid substitutions has increased in vivo half-life as compared to said antibody without said substitutions.

As explained in MPEP § 2181, during examination a means-plus-function clause is interpreted as reciting “the structure, material or act described in the specification as performing the entire claimed function and equivalents to the disclosed structure, material or act.” The structure described in Xencor’s specification as performing the claimed function of “binding human C5 protein” was the 5G1.1 monoclonal antibody.

The USPTO had invalidated this claim for lack of written description for the “method of treating” clause of the preamble, but it is not clear the means-plus-function clause would have fared any better. MPEP § 2181 cites the en banc Federal Circuit decision in Ariad Pharmaceuticals Inc. v. Eli & Lilly Co. for the proposition that when claims “use functional language to define the boundaries of a claimed genus” the specification must show that “the applicant [inventor] has invented species sufficient to support a claim to the functionally-defined genus.” While Xencor may have wanted the Federal Circuit to specifically decide whether and how Ariad applies to means-plus-function clauses, the court instead affirmed the USPTO’s finding that the specification did not demonstrate possession of “a method of treating a patient with 5G1.1 and its equivalents.”

Is This “Too Clever” Claim Drafting?

Judges have criticized “clever claim drafting” to avoid statutory requirements (or current interpretations thereof), but when patentability can turn on precise word choices, practitioners should not be blamed for trying different approaches. As the Honorable Judge Rich stated, “the name of the game is the claims.” When the rules of the game make it difficult to secure broad protection for antibody-related inventions, clever claim drafting may be a winning strategy.

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