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 .
DETAILED ACTION
Status of 17/800,029
Claims 1-7 and 9-11 are currently pending.
Priority
Instant application 17/800,029, filed 8/16/2022, claims priority as follows:
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The Examiner appreciates the submission of the certified, translated foreign priority documents on 10/21/2025. The documents support the instant claims, and thus claims 1-7 and 9-11 are granted the effective filing date of 4/7/2020.
Information Disclosure Statement
All references from the IDS submitted on 8/16/2022 have been considered unless marked with a strikethrough.
Response to Arguments/Amendments
The amendment entered 10/21/2025 has been entered. Applicant has amended claims 1-3 and 5. No claims have been deleted and no claims have been added.
In the Non-Final dated 7/22/2025, claims 1 and 2 were rejected under 35 U.S.C. 112(b). In response, Applicant has amended claims 1 and 2 to overcome and withdraw these rejections.
Claims 1-3 and 5 were rejected under 35 U.S.C. 112(a) in the Non-Final dated 7/22/2025. Upon amendment to the claims to omit the limitations, “prodrugs” and “a prodrug”, the rejection has been overcome. Thus, the rejection has been withdrawn.
In the Non-Final dated 7/22/2025, claims 1-3 and 5 were rejected under 35 U.S.C. 102(a)(1). In response, Applicant has submitted the certified, translated foreign priority documents and amended claims 1-3 and 5 to overcome the rejections. Therefore, the rejections have been overcome.
However, Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office Action.
Election/Restriction
Applicant’s election of Group I, claims 1-5, drawn to compounds of Formula I, without traverse, in the reply filed 6/11/2025 is acknowledged. Applicant’s election of the compound of the following formula:
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in the reply filed 6/11/2025, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
In the Non-Final dated 7/22/2025, the elected species was searched and prior art was identified. During the same search, an additional rejection was identified when the scope was expanded to include additional limitations of variable Y. These 102 rejections were overcome by submission of the translated, foreign priority documents and the amendments of claims 1, 3, and 5. Subsequent examination in this Office Action is based on compounds of instant formula I, where R1 is C1 alkyl, R2 is C1 alkyl, R3 is H, R4 is OH, , ---- is a double bond, X is a halogen, Y is a CH3, and W is H. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claim 1 reads on the expanded species. Claims 2-7, and 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites, “the dotted line between positions of C-1 and C-2 indicates that it may be a double bond in addition to a single bond”. However, instant formula I does not recite the position of C-1 and C-2, thus making C-1 and C-2 undefined variables. Accordingly, the claim is indefinite and unclear because the boundaries and scope for these variables are not known. The rejection can be overcome by amending the claim to recite, “the dotted line indicates that it may be a double bond in addition to a single bond”. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Chemical Abstracts [Online] 1971, Brooks, Charles J. W. and Lawson, A. M. “Studies of fluorinated corticosteroids based on gas chromatography-mass spectrometry” Horm. Steroids, Proc. Int. Congr., 3rd (1971), Meeting Date 1970, 238-47., retrieved from STN 12 Feb 2026, herein after “Brooks”. The expanded species is drawn to compounds of instant formula I, where R1 is C1 alkyl, R2 is C1 alkyl, R3 is H, R4 is OH, , ---- is a double bond, X is a halogen, Y is a CH3, and W is H.
The reference Brooks discloses the following compound:
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Which anticipates instant formula I:
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When R1 is C1 alkyl, R2 is C1 alkyl, R3 is H, R4 is OH, , ---- is a double bond, X is a halogen, Y is a CH3, and W is H. Thus, Brooks anticipates instant claim 1.
Issue of Note
Applicant has amended the independent claim 1 to recite, “where Y is selected from -CH3 or halogen”, to overcome the prior art rejection. However, Applicant has not amended claims 2 or 3 to omit the limitation of where Y is H, thus generating a lack of antecedent basis 112(b) rejection if claims 2 and 3 are rejoined.
Conclusion
Claim 1 is rejected. Claims 2-7 and 9-11 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621