DETAILED ACTION
A final Office action was mailed 18 February 2026 (“Office Action”).
Applicant’s reply to the Office Action was received 11 May 2026 (“Reply”).
An Advisory Action was mailed 24 June 2026.
Applicant’s Request for Continued Examination (RCE) was received 25 June 2026.
Status of the Claims
The listing of claims filed with the Reply has been entered via RCE and examined.
Claims 29–40 are pending. Claims 1–28 are canceled.
Claims 29 and 32–34 are amended.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Objections to the Specification
The title of the invention is objected to because it refers to the purported merits of the invention (“Novel”).
Appropriate correction is required.
For guidelines for the preparation of patent titles, see MPEP § 606 (Explaining: The word novel should not be included in the title of the invention).
Claim Interpretation
Claims 29 and 34 recite “isomer.”
The specification states: “The term ‘isomers’ refers to stereoisomers (or spatial isomers), i.e., diastereoisomers and enantiomers.” (p.7). “Compounds of the present invention may contain one or more chiral centres (asymmetric carbon atoms), therefore they may exist in enantiomeric and/or diastereoisomeric forms.” (p.62). “All possible optical isomers, alone or in a mixture with each other, fall within the scope of the present invention.” (Id.).
Based on the clear definition and other context in the specification, Examiner interprets “isomer” to mean diastereoisomers and enantiomers. The scope of “isomer” does not include positional or regio-isomers of a compound of formula (I).
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 32 and 38–40 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.” (Id.). “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011).
What is required to meet the written description requirement “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). In Ariad, the Federal Circuit explained what is required to meet the written description requirement:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 1359.
(Ariad, at 1351).
The written description of a genus, such as a chemical genus, “requires a precise structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit commented on that case in the Ariad decision:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
(Ariad, at 1350).
The factors outlined in the above Federal Circuit cases are analyzed in turn below with respect to the claimed invention.
(A) The nature and scope of the claimed invention in view of the specification: relates generally to the pharmaceutical art; and more specifically to a combination comprising a compound of Formula (I) and another drug selected from different classes of drugs and certain, specific drugs: “proteasome inhibitors; immunochemical inhibitors; steroids; bromodomain inhibitors; epigenetic drugs; cisplatin; taxol; proteasome inhibitors; kinase inhibitors; and CTLA4, PD1 or PDL1 checkpoint inhibitors.” (Amended claim 32).
With respect to a combination, the specification includes a paragraph reciting the different classes of drugs and the specific drugs listed recited in claim 32; and another paragraph discussing the diseases that may be treated using the combination. (Spec., p.62).
The specification does not provide any examples of the claimed combination. There are no examples illustrating a method of preparing a combination (e.g., a composition comprising a combination or guidance for preparing two separate medicaments for administration). There are no examples illustrating a method of administering the claimed combination to a subject, or any guidance for administering the combination (e.g., a schedule for sequential or concurrent use).
(B) The extent and content of the prior art: The compounds of Formula (I) appear to be free of the prior art. Accordingly, Applicant’s disclosure is critical to show possession.
(C) The maturity of the science or technology: While drug combinations have been used for many years to treat certain diseases like cancer, the claims are specifically directed to a combination comprising a compound of Formula (I), which have never been used to treat a disease in a subject. In view of the lack of examples and guidance in the specification for the claimed combination, the development appears to be in an infant stage.
(D) The predictability of the aspect at issue: the pharmaceutical art is generally recognized as unpredictable. In re Fisher, 427 F.2d 833, 839 (CCPA 1970). The art requires, for example, each potential drug candidate to be assessed for physiological activity. (Id.). Applications in unpredictable arts require more specific disclosures to satisfy the statutory requirement. In this case, there is no evidence suggesting the claimed invention is more predictable than the pharmaceutical art is generally.
The question of written description
After considering the above factors and evidence discussed therein, Examiner finds the specification does not adequately describe a representative number of species for the claimed genus; i.e., a combination comprising a compound of Formula (I) and another drug. There are no “species” of the combination disclosed, and guidance for making and/or using the combination is lacking. The art is unpredictable and there is no evidence that any combination has been prepared and tested for the disclosed uses to treat diseases. Accordingly, the specification does not reasonably convey to one of ordinary skill in the art that Applicant had possession of the claimed subject matter as of the filing date.
Examiner recommends canceling the claims.
Conclusion
Claims 29–31 and 33–37 are allowed.
Claims 32 and 38–40 are rejected.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to submit an Automated Interview Request: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
