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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 07/14/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 1 and 9-15 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/24/2025, 07/22/2025 and 09/05/2025 is being considered by the examiner.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US20160354334) and Tamarkin et al. (US20070280891).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Huang et al. teaches methods for (a) inhibiting, reducing, slowing, or preventing, the aging of a subject, (b) for treating, inhibiting, reducing, or preventing an age-related disease in the Subject (abstract). In some embodiments, the present invention is directed to a method for inhibiting, reducing, slowing, or preventing, the aging of a subject which comprises administering to the Subject one or more compounds that bind the beta subunit of the catalytic core of an ATP synthase, e.g., ATP5B, in the subject. In some embodiments, the present invention is directed to a method for inhibiting, reducing, slowing, or preventing, the aging of a subject which comprises administering to the Subject one or more compounds that inhibit or reduces the activity of an ATP synthase in the Subject. In some embodiments, the present invention is directed to a method for treating, inhibiting, reducing, or preventing an age-related disease in a Subject which comprises administering to the Subject one or more compounds that bind the beta subunit of the catalytic core of an ATP synthase, e.g., ATP5B, in the subject and/or inhibits or reduces the activity of the ATP synthase in the subject (page 1, [0007]). Huang et al. teaches oligomycin (an inhibitor of ATP synthase) (page 6, [0083]) in working examples (page 2, [0020]; page 12, [0117]; page 14, [0136, 0139-0140]). As used herein, “age-related diseases’ refers to alopecia, age-related hair loss, skin dry and wrinkles, hair loss/ thinning/graying, etc. (page 3-4, 0049-0050]). In one embodiment, the composition is formulated as topical formulation (page 5, [0068]).
Tamarkin et al. teaches stable oleaginous cosmetic or therapeutic foam compositions containing certain active agents, having unique therapeutic properties and methods of treatment using such compositions (abstract). The active agents include rapamycin (page 10, [0153]; page 11, [0185]). The composition are useful for treating skin disorders, such as aging skin, wrinkles (page 13, [0214]). The composition can be used to treat dermatological disorder such as alopecia, including male pattern baldness, alopecia greata, alopecia universalis and alopecia totalis; Pigmentation Disorders including Hypopigmentation such as Vitiligo, Albinism and Postinflammatory hypopigmentation and Hyperpigmentation such as Melasma (chloasma), Drug-induced hyperpigmentation, postinflammatory hyperpigmentation (page 17, [0291-293]). In one or more embodiments, the invention provides a method of treatment of a disorder of the skin, mucosal membrane, ear channel, vaginal, rectal and penile urethra disorders, comprising topical application of the foam composition of the present invention, whereby one or more active agents, in a therapeutically effective concentration to the afflicted area (page 17, [0300]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Huang et al. is that Huang et al. do not expressly teach rapamycin. This deficiency in Huang et al. is cured by the teachings of Tamarkin et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to Huang et al., as suggested by Tamarkin et al., and produce the instant invention.
Huang et al. teaches a method of treating or reducing aged related disease such as hair loss or skin winkles by administering a topical composition comprising oligomycin (an inhibitor of ATP synthase) to hair or skin.
Tamarkin et al. teaches a method by topical application of a composition comprising rapamycin to treat alopecia (stimulating hair growth and inhibit hair loss), aging akin and wrinkles, and Pigmentation Disorders including Hypopigmentation that results in treating pigmentation loss by reducing pigmentation loss and stimulating pigmentation product inherently.
One of ordinary skill in the art would have been motivated to treat hair loss or aging skin such as wrinkles by administering a topical composition comprising a combination of oligomycin and rapamycin because both a composition comprising oligomycin and a composition comprising rapamycin are useful for treating hair loss and aging skin such as wrinkles as suggested by Huang et al. and Tamarkin et al. MPEP 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it is obvious for one of ordinary skill in the art to treat hair loss or aging skin such as wrinkles by administering a topical composition comprising a combination of oligomycin and rapamycin and produce instant claimed invention with reasonable expectation of success.
Regarding claim 10, since applicants elected tropical formulation (a single grouping of patentably indistinct species) encompassing gel or cream as common topical formulation, thus, it is obvious to have gel or cream.
Regarding claims 11-13, the treating of skin by a composition comprising combination of oligomycin and rapamycin results in stimulating, treating or reducing pigmentation loss.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin et al. (US20070280891) and Orlow et al. (US20040265252).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Tamarkin et al. teaching has already bene discussed in the above 103 rejection and is incorporated herein by reference.
Orlow et al. teaches a method for increasing pigmentation in a subject comprising administering to a subject an effective amount of oligomycin that stimulates pigmentation (claims 6 and 10). Orlow et al. further teaches topical formulation such as gel, cream, and lotion (page 23, [0151]). Orlow et al. teaches topical formulation treating hair for stimulating hair color and visual appearance of hair or skin (page 21, [0130]; page 22, [0143]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Tamarkin et al. is that Tamarkin et al. do not expressly teach oligomycin. This deficiency in Tamarkin et al. is cured by the teachings of Orlow et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tamarkin et al., as suggested by Orlow et al., and produce the instant invention.
Tamarkin et al. teaches a method by topical application of a composition comprising rapamycin to treat alopecia (stimulating hair growth and inhibit hair loss), aging akin and wrinkles, and Pigmentation Disorders including Hypopigmentation that results in treating pigmentation loss by reducing pigmentation loss and stimulating pigmentation product inherently.
Orlow et al. teaches a method for increasing pigmentation in a subject comprising administering to a subject an effective amount of oligomycin that stimulates pigmentation and treating hair for stimulating hair color and visual appearance of hair or skin
One of ordinary skill in the art would have been motivated to treat pigmentation by administering a topical composition comprising a combination of oligomycin and rapamycin because both a composition comprising oligomycin and a composition comprising rapamycin are useful for treating pigmentation as suggested by Orlow et al. and Tamarkin et al. MPEP 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it is obvious for one of ordinary skill in the art to treat pigmentation by administering a topical composition comprising a combination of oligomycin and rapamycin and produce instant claimed invention with reasonable expectation of success.
Regarding claim 10, since applicants elected tropical formulation (a single grouping of patentably indistinct species) encompassing gel or cream as common topical formulation, thus, it is obvious to have gel or cream.
Regarding claim 14-15, since a composition comprising rapamycin treats alopecia (stimulating hair growth and inhibit hair loss), a composition comprising rapamycin and oligomycin after being applied on hair results in treating alopecia (stimulating hair growth and inhibit hair loss).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that there is no teaching of amended claim.
In response to this argument: this is no persuasive. The modified 103 rejections teach each limitation of amended claimed invention, and the 103 rejections are still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 9-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-12, 17, 19-20 of copending Application No. 17935693 in view of Huang et al. (US20160354334) and Tamarkin et al. (US20070280891). The reference application teaches a method for treating aged related disease by administering inhibitor of ATP synthase, in view of Huang et al. teaching aged related disease including hair loss and oligomycin as inhibitor of ATP synthase and Tamarkin et al. teaching rapamycin for treating hair loss, it is obvious to apply a composition comprising oligomycin and rapamycin produce applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowable.
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 JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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