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 Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on December 11, 2025. Claim(s) 1, 2, 4-6, 8, 10-14, 16-20, and 23-27 are pending. Claim(s) 20 and 23-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a compound of Formula I and pharmaceutical compositions thereof and election of species of:
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, without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim(s) 1, 2, 4-6, 8, 10-14, 16-19 are examined herein insofar as they read on the elected invention and species. The elected species was found free of the art, therefore the search was expanded to a genus encompassing Formula I in its entirety.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 4-6, 8, 10-14, 16-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 7-12, and 15-18 of U.S. Patent No. 11,083,699. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to compounds of formula I. The patented claims teach compounds, compositions and methods of administering a compound of formula as set forth in patented claim 1. Patented compound:
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is specifically taught (claims 7 and 15). Said compound is embraced within the scope of the instant claims.
Thus, the claims are unpatentable over the patented claims.
Claims 1, 2, 4-6, 8, 10-14, 16-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6, 9-17, 20, and 21 of U.S. Patent No. 11,026,904. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to compounds of formula I. The patented claims teach compounds, compositions and methods of administering a compound of formula as set forth in patented claim
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Patented compounds:
are specifically taught (claims 9 and 20). While said compounds are embraced within the scope of the instant claims, when T is absent, the compounds are not taught to have a molar ratio of (R, R) to (S, S) configuration greater than 1:1 as required by the instant claims. The expectation with regard to enantiomers is that activities as they pertain to living systems are expected to be different. In re Adamson, 275 F.2d 952, 125 PS.P.Q. 233 (C.C.P.A. 1960). The fundamentals of optical activity and stereoisomerism are well known to persons having ordinary skill in the art. A person having ordinary skill in the art would have known how to resolve the racemic mixture and would have been motivated to do so with the reasonable expectation of achieving enantiomers having substantially different pharmacological activity. It appears as though applicant has determined experimentally what a person of ordinary skill in the art would have expected, namely, that the racemic mixture of the prior art may be separate (+) and (-) enantiomers possessing substantial different pharmacological activity. This is an expected result. It is well established that expected beneficial results are evidence of obviousness of a claimed invention just as unexpected beneficial results are evidence of unobviousness. In re Skoll, 523 F. 2d 1392, 187 U.S.P.Q. 481 (C.C.P.A. 1975); In re Skoner, 517 F. 2d 947, 186 U.S.P.Q. 80 (C.C.P.A. 1975); In re Gershon, 372 F. 2d 535, 152 U.S.P.Q. 602 (C.C.P.A. 1967). Thus, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
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.
Claims 1, 2, 6, 14, 16, and 19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Seeberger (WO 2015004041).
Seeberger teaches compound A49 and pharmaceutical formulations thereof (page 115-116):
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.
The instant compound meets the limitations of claims 1, 2, 6, 14, 16, and 19.
Based on the foregoing reasons, the instant claims are deemed anticipated over the cited art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4, 5, 8, 10-13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Seeberger (WO 2015004041) as applied to claims 1, 2, 6, 14, 16, and 19 in the 102(a)(1) rejection above.
Seeberger is discussed above.
Compound A49 is embraced by Formula I of the instant claims wherein T is C1 alkylene, not T is absent nor is it taught to have a molar ratio of (R, R) to (S, S) configuration greater than 1:1 as required by the instant claims.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at compounds embraced by Formula I of the instant claims based on the teachings of Seeberger. Absent secondary considerations, compounds that differ only by the presence of an extra methyl group are homologues which are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. The homologue is expected to be preparable by the same method and to have the same properties. This expectation is then deemed the motivation for preparing homologues. Homologues are obvious even in the absence of a specific teaching to methylate, In re Wood 199 USPQ 137; In re Hoke 195 USPQ 148; In re Lohr 137 USPQ 548; In re Magerlein 202 USPQ 473; In re Wiechert 152 USPQ 249; Ex parte Henkel 130 USPQ 474; In re Fauque 121 USPQ 425; In re Druey 138 USPQ 39. In all of these cases, the close structural similarity of two compounds differing by only one (or two) methyl groups sufficed; no specific teaching to methylate was present or required. None of these cases has been overruled and indeed the examiner is unaware of any post Lohr case in which motivation is required to put a methyl group on an old compound.
Moreover, the expectation with regard to enantiomers is that activities as they pertain to living systems are expected to be different. In re Adamson, 275 F.2d 952, 125 PS.P.Q. 233 (C.C.P.A. 1960). The fundamentals of optical activity and stereoisomerism are well known to persons having ordinary skill in the art. A person having ordinary skill in the art would have known how to resolve the racemic mixture and would have been motivated to do so with the reasonable expectation of achieving enantiomers having substantially different pharmacological activity. It appears as though applicant has determined experimentally what a person of ordinary skill in the art would have expected, namely, that the racemic mixture of the prior art may be separate (+) and (-) enantiomers possessing substantial different pharmacological activity. This is an expected result. It is well established that expected beneficial results are evidence of obviousness of a claimed invention just as unexpected beneficial results are evidence of unobviousness. In re Skoll, 523 F. 2d 1392, 187 U.S.P.Q. 481 (C.C.P.A. 1975); In re Skoner, 517 F. 2d 947, 186 U.S.P.Q. 80 (C.C.P.A. 1975); In re Gershon, 372 F. 2d 535, 152 U.S.P.Q. 602 (C.C.P.A. 1967). Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1, 2, 4-6, 8, 10-14, 16-19 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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