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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/4/2025 has been entered.
Status of the Claims
Claims 1, 6-9, 12-15, and 24-25 are pending. Claims 6-9, 12-14, and 24-25 are withdrawn. Claims 1 and 15 are rejected.
Response to Amendments/Arguments
Applicant’s amendments and arguments, filed 11/4/2025, with respect to the rejection(s) of claim(s) 1 and 15 under 112(a) and 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below with a new matter 112(a) rejection and a new 35 USC 102 rejection. Because all previous rejections were overcome by amendments, Applicant’s 11/4/2025 arguments will not be addressed.
Claim Objections
Claim 1 is objected to because of the following informalities: The structure in claim 1 has both a “(I)” and a “(III)” next to it. Applicant should clarify with one or the other roman numeral. Appropriate correction is required.
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.
Claim 1 is 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.
Amended claim 1 has added the following restrictions to the end of the claim:
“R1 is hydrogen and R6 is a hydrogen, an alkyl, or an ethanol; or
R1 is methyl and R6 is a hydrogen, an ethyl, or an ethanol.”
The original disclosure does not support this embodiment/combination. Additionally, the current (withdrawn) claims are drawn to embodiments that do not obey by these rules. See Compound 88 in claim 14:
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, wherein R1 is methyl and R6 is butyl. “A claim that omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement”. See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d at 1503; In re Sus, 306 F.2d 494, 504, 134 USPQ 301, 309 (CCPA 1962). See MPEP 2163.05(IA). Therefore, this is a new matter rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holland et al. (Journal of Labelled Compounds and Radiopharmaceuticals-XXVII, No. 6, 1989).
Regarding instant claim 1, Holland discloses the following compound (norethindrone):
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, which is embraced by a compound of instant formula (III):
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wherein X = =O; R1 = H; R6 = H; R2 = H; R5=H (see top of p. 630). Regarding instant claim 15, Holland additionally discloses this compound labelled with deuterium and tritium “which utilizes water as the source of the label” (see “Summary”), wherein water is a pharmaceutically acceptable excipient. A skilled artisan would at once envisage a composition with the compound supra and water.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626