DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 17-18 and 23-41 are pending
Claims 17-18 and 23-41 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/31/2024 and 07/14/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of PCT Application No. PCT/CN2022/089735 filed on 04/28/2022, PCT Application No. PCT/CN2021/115754 filed on 08/31/2021, and PCT Application No. PCT/CN2021/091613 filed on 04/30/2021.
Election/Restrictions
Applicant’s election without traverse of Compound 188 and Alzheimer’s Disease in the reply filed on 05/11/2026 is acknowledged. Since compounds of formula I appear free of the prior art, the species elections are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 17-18 and 23-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the inhibition of CD38 by administering Compounds 1-195, does not reasonably provide enablement for the treatment of any disease mediated by CD38 comprising administering any compound of formula I. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, "Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue', not 'experimentation'" (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations" (Wands, 8 USPQ2d 1404). Among these factors are: (i) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of treating any disease or disorder using a compound of formula I. The breadth of the claims thus covers that the compounds are capable of therapy of potentially any and every known condition or disease associated with CD38. For example, the breadth of the claims covers a variety of cancers, including glioblastoma and lung cancer. Such a wide range of conditions and diseases have completely different etiologies.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the art as shown by Danziger et al that many aspects and modalities are involved in the pharmaceutical art, which as a result makes that art highly unpredictable. Pharmacological activity in general is a very unpredictable area. Note that in cases, involving physiological activity such as the instant case, "the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved". Se In re Fisher, 427 F.2d 833,166 USPQ 18, 24 (CCPA 1970).
The article while directed to automated drug design, specifically addresses the issue of steric hindrance which essentially means that the shape, design, including the kinds and amount of substituents greatly affect the ability and efficacy of a drug to bind to the desired receptor and function appropriately. Thus, the use of the three recited compounds, which contain different amino groups as substituents, would be unpredictable in treating any and every known condition or disease.
Within the scope of cancers, which does not cover the full breadth of the claimed invention, Simone (Introduction: Oncology) teaches that for all cancers, "each specific type has unique biologic and clinical features that must be appreciated for proper diagnosis, treatment and study” (pg. 1004). Furthermore, different types of cancers affect different organs and have different methods of growth and harm to the body. Thus, it is beyond the skill of oncologists today to get an agent to be effective against a wide range of cancers.
(5) The relative skill of those in the art:
Those of relative skill in the art are those with a level of skill of the authors of the references cites to support the examiner’s position (MD’s or those with advanced degrees and the requisite experience in medicine).
(6) The amount of direction or guidance presented and (7) the presence of absence of working examples:
The specification provides working examples only for the inhibition of CD38 for Compounds 1-195. Thus, the specification has only provided working examples for in vitro activity for Compounds 1-195, but not for the treatment of any disease or disorder associated with CD38, particularly other cancers by administering any compound of formula I.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Danziger and Simone above, and the high unpredictability in the art as evidenced therein, and the lack of guidance provided by the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Conclusion
Claims 17-18 and 23-41 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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