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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Claims 2, 5, 6, 9, 10, 14-16, 21, 22 and 24-31 are pending in the application.
This action is in response to applicants' amendment dated August 26, 2025. Claims 2, 9, 14, 16, 21, 22 and 25-28 have been amended, claims 17 and 23 have been canceled and claims 29-31 are newly added.
Response to Amendment
Applicant's arguments filed August 26, 2025 have been fully considered with the following effect:
With regards to the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 1) in the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants’ remarks concerning claims 14-17 and 21-28 were such that the claims are directed to methods of activating a Ɣδ T-cell immune response, the methods respectively comprising administering to a subject an effective amount of a compound as defined in claim 2 and a pharmaceutical composition comprising the compound of claim 2 as defined in claim 10. The applicants also stated that the scope of the amended claims (activating Ɣδ T-cells) is fully enabled by Applicant’s specification as filed. Applicant’s specification provides ample evidence that the claimed compounds, and pharmaceutical compositions comprising the compounds, are potent activators of a Ɣδ T-cell response. However, claims are read in light of the specification. The Patent and Trademark Office determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction “in light of the specification as it would be interpreted by one of ordinary skill in the art” In re Am. Acad. Of Sci. Tech. Ctr. 367 F.3d 1359, 1364[70 USPQ2d 1827, 1830] (Fed. Cir. 2004). The applicant’s specification indicates that “it would be desirable to provide compounds that combine excellent stability with potent activation of VƔ9/Vδ2 T-cells for use in treating infections, proliferative diseases such as cancer and/or osteoporosis.
Recent journal article Cieslak et al., herein provided indicates that while Gamma-delta (Ɣδ) T cells have shown great promise in pre-clinical and clinical studies, however, their role in cancer remains complex due to their ability to exert both beneficial and detrimental effects on tumor progression. Cieslak discusses the increase in ovarian cancer through the secretion of IL-17A producing Ɣδ T-cells as well as colorectal cancer, squamous cell carcinoma, HPV-associated uterine cervical squamous cell carcinoma, gallbladder cancer, hepatocellular carcinomas, mammary cancers, etc. Cieslak also indicates that possible pro-tumor functions of Ɣδ T cells may not solely rely on IL-17 production. Additional potential mediators include PD-L1, galectin 1, and galectin 9 which suppress effector T cells when interacting with PD-1 and glycosylated receptors, respectively. The information presented in the specification, coupled with the knowledge of those skilled in the art, fails to provide sufficient direction and guidance as to methods of identify compounds that activate a Ɣδ T-cell immune response without undue experimentation. 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 where the method is for activating a Ɣδ T-cell immune response. However, as indicated in the last office action the scope of claims 14, 15, 21, 24, 25 and 27 includes any and all diseases, which may be associated with Ɣδ T-cell immune response. The claims include any and all diseases associated with the Ɣδ T-cell immune response that are neither supported nor contemplated as well as diseases and disorders not even known at this time. It is difficult to treat many of the disorders claimed herein.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a).
Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
Claims 14, 15, 21, 24, 25 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention, for reasons of record and stated above.
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, labeled paragraph 4a) in the last office action, which is hereby withdrawn.
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 102(a)(1), anticipation rejection, labeled paragraph 3) in the last office action, which is hereby withdrawn.
In view of the amendment dated August 26, 2025, the following new grounds of rejection apply:
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 2, 5, 6, 10, 14-16, 21, 22, 24-28 and 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amendment to claim 2 where the definition of R7 is amended to include the following moiety C6-14 group which is not described in the specification with respect to the compounds of Formula (IV). Additionally, the definition of R7 in new claim 31 is not described in the specification.
Applicant is required to cancel the new matter in the reply to this Office action.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 5, 6, 10, 14-16, 21, 22, 24-28, 30 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. The following reasons apply:
Claim 2 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the definition of R7 which is “a C6-14 group”.
Claim 30 recites the limitation "benzyl group" in the definition of R7. There is insufficient antecedent basis for this limitation in the claim. A benzyl group is not an aryl group. An AI definition when googled is as follows:
No, a benzyl group is not the same as an aryl group; an aryl group is any functional group derived from an aromatic ring by removing a hydrogen atom, whereas a benzyl group is specifically a phenyl group (C₆H₅) attached to a methylene (CH₂) group. The key difference is that the attachment in a benzyl group is to the methylene carbon, not directly to the aromatic ring itself.
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https://www.masterorganicchemistry.com/2018/06/13/reactions-on-the-benzylic-carbon-bromination-and-oxidation/#three
Claim 31 recites the limitation "unsubstituted benzyl group" in the definition of R7. There is insufficient antecedent basis for this limitation in the claim.
Claim Objections
Claims 9 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624