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 .
Claim Status
Claims 1-5 and 7 are pending.
Claims 1, 5, and 7 are currently amended.
Claim 6 is cancelled.
Claims 1-5 and 7 have been examined.
Claims 1-5 and 7 are rejected.
Priority
Priority to 371 PCT/CN2021/085266 filed on 04/02/2021, which claims priority to Chinese patent application 202010959998.3 filed on 09/14/2020 is acknowledged.
Withdrawn Objection to the Specification
The objection to the specification from the previous Office Action is withdrawn in view of the amendments the specification.
Withdrawn Claim Rejections - 35 USC § 112
Response to Applicant’s Arguements
The rejection of claim 5 for containing a trademark/trade name is withdrawn in view of the amendment to the claim.
Withdrawn and Maintained Claim Rejections - 35 USC § 103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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
This rejection is modified and reiterated from the previous Office Action in view of the amendments to the claims.
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dalton et al. (International Application Published Under the PCT WO 03/074473 A2, Published 09/12/2003) in view of Zhu et al. (International Application Published Under the PCT WO 2015/109666 A1, Published 07/30/2015).
Dalton et al. teach a method of treating dry condition in a subject suffering from dry eyes comprising the step of administering to said subject the selective androgen receptor modulator compound
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in an amount to treat dry eyes in the subject (prior art claims 43 and 59). The selective androgen receptor modulator compound can be selected from
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, wherein T can be selected from OH and NHCOCH3 and R3 is selected from NO2 and COOH (prior art claim 1). The pharmaceutical preparation can be in the form of oily solutions (salve) and comprise an oily vehicle such as petroleum (VASELINE) and mineral oil (paragraphs 000174 and 000175). The selective androgen receptor modulators are useful in treatment of a variety of hormone-related conditions, for example conditions associated with androgen decline in aging male (paragraph 00062).
Dalton et al. lacks a preferred embodiment wherein the aromatic propionamide compound contains an ester group. Dalton et al. however makes such a compound obvious.
Dalton et al. lacks a teaching wherein the compound is one of those in instant claims 6 and 7.
Zhu et al. teach compounds that regulate an androgen receptor (abstract). A preferred compound is
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(page 11, lines 7-10).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to modify the compound of Dalton et al. to contain an ester group and have a reasonable expectation of success. One would have been motivated to do since Dalton et al. teach ester groups can be substituents as an alternative to OH and NO2 in the compound. For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to use the compound of Zhu et al. in the method of Dalton et al. and have a reasonable expectation of success. One would have been motivated to do so since Dalton et al. and Zhu et al. teach such compounds are functional alternatives. Therefore, the instant claims are rendered obvious by the teachings of the prior art.
Response to Applicant’s Arguments
The rejection of claims Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dalton et al. (International Application Published Under the PCT WO 03/074473 A2, Published 09/12/2003) is withdrawn in view of the amendments to the claims.
The rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Dalton et al. (International Application Published Under the PCT WO 03/074473 A2, Published 09/12/2003) in view of Zhu et al. (International Application Published Under the PCT WO 2015/109666 A1, Published 07/30/2015) is moot since the claim is cancelled.
With regard to the rejection of claims 1-5 and 7 under 35 U.S.C. 103 as being unpatentable over Dalton et al. (International Application Published Under the PCT WO 03/074473 A2, Published 09/12/2003) in view of Zhu et al. (International Application Published Under the PCT WO 2015/109666 A1, Published 07/30/2015):
Applicant argues that Dalton et al. does not teach the instantly claimed compound. Applicant’s argument has been fully considered but found not to be persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that Zhu et al. does not teach using the instantly claimed compound for the treatment of dry eyes. Applicant’s argument has been fully considered but found not to be persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that there would be no motivation to combine the teachings of Dalton et al. and Zhu et al. since the compounds of Dalton et al. and Zhu et al. are “very different”. Applicant’s argument has been fully considered but found not to be persuasive. Firstly, the compounds are not very different from each other. The basic backbone of the two compounds are very similar. Furthermore, the compounds of both Dalton et al. and Zhu et al. have similar functionality. They are both androgen receptor modulators.
Applicant finally argues that since Zhu et al. does not disclose the use of the instantly claimed compound for the purpose of treating dry eyes one of ordinary skill in the art would not have had an expectation of predictability in achieving therapeutic effect. Applicant’s argument has been fully considered but found not to be persuasive. The Applicant focuses their arguments on what Zhu et al. teaches. However, if one looked to Dalton et al., it is Dalton et al. that teach using androgen receptor modulators for the purpose of treating dry eyes. It would therefore be expected that treating dry eyes with the use of other androgen receptor modulators, especially ones that share a similar molecular structure, would also be successful. Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). Here, it is reasonable given the teachings of Dalton et al. that one would expect other androgen receptor modulators, particularly those with similar structures, to also be capable of treating dry eyes.
For the foregoing reasons the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614