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
Response to Amendment
The amendment filed 5/04/2026 has been entered. Newly amended Claims 1-8 and 11-15 are pending in the application. Claims 6-7 and 11-14 remain withdrawn, and Claims 1-5, 8, and 15 are examined on the merits herein.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Applicant argues Claims 5 and 15 are rewritten as suggested by examiner and are now allowable. This argument is not persuasive because the cited claims are not rewritten in the latest claim amendments. Examiner wrongly indicated Claims 5 and 15 as objected to; however, the rejection correctly described the first compound of Claim 5 and the compositions of Claim 15 as obvious. The grounds of rejection are not changed and the rejection is reissued hereinbelow. The status of the claims is corrected.
Applicant argues it would not be obvious to modify the Chin compound as suggested by Chin: (1) a PHOSITA would not have selected the identified compound out of 282 total compounds as a lead compound for obviousness analysis and (2) the specific substitution at Y is improbable because several other variable positions exist at R1, R2, R3, and R4 with a large number of alternative groups, failing to provide motivation or reasonable expectation of success. Applicant’s arguments are fully considered but not persuasive for the following reasons:
Regarding the first argument, applicant conflates the definition of ‘lead compound’ from the perspective of a pharmaceutical chemist with its legal definition. The Federal Circuit in Eisai makes it clear that from the perspective of the law of obviousness, any known compound might possibly serve as a lead compound: "Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound." Eisai, 533 F.3d at 1357, 87 USPQ2d at 1455. There must be some reason for starting with that particular lead compound other than the mere fact that the "lead compound" exists. (See MPEP 2143 I B Example 9.) The reason for having selected said compound for modification was provided by examiner on Pages 4-5 of the nonfinal action mailed 2/05/2026; “Chin teaches the following compound
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as an inhibitor of oxidative stress” Therefore, the compound of Chin referenced herein is indeed a lead compound as defined in the MPEP due to its use as an oxidative stress inhibitor in the prior art. Note too that a compound does not have to be the “most preferred” or “most potent” compound to be obvious. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (a conclusion of obviousness does not require “something in the prior art as a whole to suggest that the combination is the most desirable combination available”). See also In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971) (Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments.). See In re Lamberti, 545 F.2d 747, 750 (CCPA 1976) (explaining that “all disclosures of the prior art, including unpreferred embodiments, must be considered”); cf. In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012) (noting that “just because better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes”), In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (stating that “finding that the prior art as a whole suggests the desirability of a particular combination need not be supported by a finding that the prior art suggests that the combination claimed by the patent applicant is the preferred, or most desirable, combination”), Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1008 (Fed. Cir. 2009). See also Merck & Co., Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)) (“[I]n a section 103 inquiry, ‘the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered.’”). See also In re Mills, 470 F.2d 649,651 (CCPA 1972) ("All the disclosures in a reference must be evaluated, including nonpreferred embodiments, and a reference is not limited to the disclosure of specific working examples.").
Applicant states Chin does not disclose “guiding teaching with cancer treatment”. This statement is incorrect. Chin teaches “Activation of transcription factors implicated in cancer (e.g., NF-kappa B and STAT3) has been reported in PAH (e.g., Paulin et al., 2012; Hosokawa, 2013)” (Page 5). Pulmonary arterial hypertension (PAH) is described by applicant as a “disease indication” in Chin by applicant on Page 7 of the Remarks filed 5/04/2026. However, the examined claims are drawn to compounds rather than methods of treating a specific disease.
Regarding the second argument, examiner starts with the lead Chin compound and forms a single modification in view of what Chin permits as an acceptably substituted alkenyl group. The seven alternative embodiments described in the list of “examples of alkenyl groups” on Page 104 do not require further substitution or variation in the described R1-R4 groups. Therefore, the substitution is not nearly as improbable as applicant submits. The ability to modify the compound according to Chin is taught therein and expected to yield an inhibitor of oxidative stress. The motivation to form an inhibitor of oxidative stress and the means of doing so is taught in Chin.
It is noted for applicant’s benefit that no substituted phenyl-alkenyl group is taught in the list of seven alternative embodiments. Only unsubstituted phenyl is taught.
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.
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 8, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chin (WO2015027206, cited in 5/24/2025 IDS).
Chin teaches the following compound
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as an inhibitor of oxidative stress (Page 58; Page 54, Lines 16-22). The Chin compound differs from the following compound
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,
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of Claim 5 encompassed within formula 1, in that the Chin compound lacks a phenyl substituent on the acrylamide moiety. The definitions of examined formula I apply to the above compound in that R1, R2, and R3 are H. Chin teaches the acrylamide, NHC(O)Re wherein Re is alkenyl, containing the vinyl -CH=CH2 can instead be a 3-phenyl acrylamide (Page 53, Lines 7-9; Page 104, Lines 18-24). Chin teaches CH=CH-C6H-5 in a list of seven total acceptable alkenyl embodiments. Chin teaches compositions comprising the compound in compositions with various adjuvants (Page 10, Lines 13-25).
One of skill in the art seeking to form an oxidative stress inhibitor, in light of Chin teaching 3-phenyl acrylamide as an alternative embodiment to the vinyl of the Chin compound above, would find it obvious to make the substitution and form the following compound of instant Claim 5:
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. The same artisan would expect the successful formation of the oxidative stress inhibitor because Chin explicitly teaches the substitution of the vinyl and suggests that such examples of alternative embodiments are nonlimiting. Chin implies a great degree of variability in the acrylamide moiety is tolerated when forming such an inhibitor.
Conclusion
No claim is allowable.
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 extension fee 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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