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 .
Application and Claims Status
Claims 21-22 were pending. In the amendment as filed on March 4, 2026, applicants have amended claims 21-22; cancelled no claims; and added no new claims. Therefore, claims 21-22 are currently pending.
Specification - Abstract
The objection to the abstract is withdrawn based on the amendments.
Claim Rejections – 35 USC § 112(a)
The rejection of claims 21-22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as not enabling for prevention, is withdrawn based on the amendments.
Double Patenting
The nonstatutory double patenting rejection over U.S. Patent No. 9,428,502 B2 is being withdrawn for the following reason: Reference claim 4 and its parent claim 1 are not actually drawn to compounds of instant claims 21 and 22. Reference claim 1 recites the proviso that:
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135
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, then:
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.
Therefore, the method of reference claim 4 does not read on any of the instant claims.
Response to Arguments – 35 USC § 103
Applicant's arguments filed March 4, 2026 have been fully considered but they are not found persuasive.
Applicant first argues: the claims are not obvious under 35 USC § 103 because the Office has failed to show that the compound would have been chosen, or in other words, that the compound recited in instant claims 21-22 would have been chosen as the “lead compound” from U.S. Patent No. 8,871,790 B2 (hereinafter, the “’790 Patent”) for further development for the treatment of acne (see Applicant Remarks, Pages 5-7). Examiner respectfully disagrees for the following reason:
The instantly claimed compound is Compound 152 of ’790 Patent. Reference Table 1, column 603-604, provides data for this compound as having 55 nM potency (FASN IC50 (µM) = 0.055) against FASN, or Fatty Acid Synthase, which is also the targeted enzyme for inhibition in the instant application. Of the compounds synthesized in the ’790 Patent, Compound 152 is among the more potent compounds against FASN. Therefore, a more potent compound (among the collection of compounds synthesized) is indeed obvious to try as a potential lead compound. Examiner is in no way suggesting it would have been picked first, but it would have been ‘obvious to try,’ owing to its higher potency.
Thus, for the reasons stated above, it would have been obvious to at least try instantly claimed compound, and choose it for further development. Per MPEP 2145(X)(B): “An "obvious to try" rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.” One skilled in the art would have been choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success: In the instant case, picking each and any one of the disclosed compounds from the ‘790 Patent would be equally obvious to try because the prior art teaches that these are all alternatives to inhibit the FAS enzyme, and there is indeed, a finite number of compounds in the ‘790 Patent. If that weren’t enough, which it is, the ’790 Patent further discloses the potency of all of these compounds, of which the instantly claimed compound is among the more potent, thus providing even stronger rationale for an “obvious to try” argument.
On Page 6 of the Remarks, Applicant argues, “the ‘mere fact’ that the compound exists and is claimed is not sufficient evidence that it would have been chosen for further development, especially for alleviating the symptoms of acne” (emphasis added). Per MPEP 2145(IV): “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).” The ‘790 Patent alone does not suggest choosing instantly claimed compound for alleviating the symptoms of acne, but rather “the test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA].” In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).
Applicant rounds out this argument, on Page 6 of the Remarks, with “the rejection appears to rely on impermissible hindsight reconstruction”. In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The motivation does not rely solely on knowledge gleaned only from the Applicant’s disclosure, and thus, the argument is not considered persuasive.
Applicant next argues: the U.S. Patent No. 8,614,238 (hereinafter, the “’238 Patent”) would not have led one of skill in the art to have a reasonable expectation of success for treating acne, primarily because Applicant claims that the lead compound in the ‘238 Patent had significant adverse effects on the skin, and thus teaches away from a treatment of acne (see Applicant Remarks, Pages 8-10). Again, Examiner respectfully disagrees for the following reasons:
First, the ‘238 Patent teaches an entirely different structure and scaffold than instantly claimed compound—they share no similar structural features. Therefore, one cannot predict if the adverse effects from one molecule will exhibit the same adverse effects in an entirely dissimilar molecule. There could be a long list of reasons for this: perhaps the molecule in the ‘238 Patent is able to bind and inhibit off-target enzymes, thus leading to adverse skin events; perhaps the ‘238 Patent lead molecule gets metabolized by CYP450 enzymes because it contains metabolic hotspots, thus leading to adverse skin events. The list can go on.
Second, it’s a truth universally known that the dose makes the poison in drug discovery. Even an FDA-approved pharmaceutical composition in a high enough dose can kill a patient, but this has not stopped the flow of FDA-approved drugs. The Applicant cites Col 18, line 5-9 of the ‘238 Patent (Col 18, lines 5-9), as evidence of teaching away the administration of an FASN inhibitor because of adverse skin events. However, the line immediately preceding this states: “Beginning with day 4 of treatment, at the highest dose effects on skin and coat of the animals could be detected” (‘238 Patent, col 18, line 3-5). The ‘238 Patent discloses that it is being administered to rats at the highest dose. One of ordinary skill in the art would recognize that there are dose-escalation studies across any therapeutic treatment in order to find a drug’s proper therapeutic index, and this does not mean it is the dose of drug that will be administered thusly. It appears that the data cited against the Examiner is being cherry-picked in order re-enforce the Applicant’s position that the references “teach away” from the presently claimed subject matter.
Regardless of the Examiner’s above points, MPEP 2145(X)(D)(1) explicitly states:
The Nature of the Teaching Is Highly Relevant
A prior art reference that "teaches away" from the claimed invention is a significant factor to be considered in determining obviousness. However, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (Claims were directed to an epoxy resin based printed circuit material. A prior art reference disclosed a polyester-imide resin based printed circuit material, and taught that although epoxy resin based materials have acceptable stability and some degree of flexibility, they are inferior to polyester-imide resin based materials. The court held the claims would have been obvious over the prior art because the reference taught epoxy resin based material was useful for the inventor’s purpose, applicant did not distinguish the claimed epoxy from the prior art epoxy, and applicant asserted no discovery beyond what was known to the art.).
Furthermore, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.") (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)); and Schwendimann v. Neenah, Inc., 82 F.4th 1371, 1381, 2023 USPQ2d 1173 (Fed. Cir. 2023) ("Although Oez [the prior art] used a white pigment with a cross-linking polymer, it does not discourage a skilled artisan from using the white pigment without a cross-linking polymer or lead the skilled artisan in a direction divergent from the path taken in the Appealed Patents. Thus, Oez's disclosure is substantial evidence that supports the Board's finding that Oez does not teach away from the proposed combination."). (emphasis added)
Applicant argues: “there is no statement of such compounds [FASN inhibitors] will actually be useful for treating such conditions, such as alleviating symptoms of acne” (see Applicant Remarks, Page 9). To this point, the Examiner would like to reinforce the teachings of the D’Arcangelis disclosure, which was not addressed in any substantive way in Applicant’s Remarks. D’Arcangelis discloses a cosmetic composition for reducing sebum production, comprising a sebum production reducing effective amount of a FAS inhibitor. D’Arcangelis teaches the discovery that “the inhibition of the activity of FAS results in a decrease in sebum production in sebocytes” (page 1, para 0023) and that “excessive sebum production is cosmetically undesirable and has been associated with the skin condition acne” (page 1, para 0004). Thus, D’Arcangelis teaches that an FAS inhibitor results in decreased sebum production, which is associated with acne. Thus, there is a statement that FASN inhibitors would be useful for treating acne.
Therefore, the Examiner is not convinced that the combined references teach away from the presently claimed subject matter, and thus, the arguments are not found persuasive.
Altogether, the scope of the claims 21-22 are deemed obvious and the 35 USC § 103 rejection is maintained.
Response to Arguments – Double Patenting Rejections
Applicant's arguments filed March 4, 2026 have been fully considered but they are not found persuasive.
As explained in the “Double Patenting” section of this Office Action, the nonstatutory double patenting rejection over U.S. Patent No. 9,428,502 B2 is withdrawn.
The Examiner set forth obviousness-type double patenting rejections which are akin to a 35 USC § 103 rejection. The same secondary references (‘238 Patent and D’Arcangelis) are used in the double patenting rejections as in the 103 rejections. Examiner maintains his position that the disclosures of these references teach that a FASN inhibitor can be used to treat acne, as explained previously (see Response to Arguments – 35 USC § 103). Furthermore, the method of treating acne of instant claims 21-22 overlap in claimed matter with at least claim 20 and the disclosed utility in the reference disclosure of the issued U.S. patent. Thus, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is obvious over the reference claims and a nonstatutory double patenting rejection is proper.
Altogether, the nonstatutory double patenting rejection over U.S. Patent No. 8,871,790 B2 is maintained.
Conclusion
Claims 21-22 are rejected.
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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/L.A.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624