DETAILED ACTION
1. Receipt is acknowledged of Applicant’s amendments and remarks filed 10/21/2025.
INFORMATION DISCLOSURE STATEMENT
2. No New Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
NEW REJECTIONS
Claim Rejections- 35 USC § 103
4. 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.
Claims 1-13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Shinhiko (WO 2009113426) and further in view of Subbiah et al. (US 20170258917), Benjamin et al. (US 20110136210), Newell et al. (US 20140013989) and Faucher (US 20110070372).
Shinhiko (WO 2009113426) disclose a composition of application to skin comprising lipofullerene and an activator comprising a physiologically acceptable carrier. The reference does not disclose the activator promotes transdermal intracellular uptake of lipofullerene, however polyvinylpyrrolidone is taught and polyvinylpyrrolidone is known in the art to solubilize and enhance dermal uptake of active ingredients. Thus, PVP is considered the “activator” (see Examples 3 and 7). It is dissolved in water (Example 7). While a “composition for use in promoting hair growth and/or inhibiting hair loss” is not disclosed, it is noted that the intended use of the composition is given little patentable weight. It must be noted that the recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.Cir. 1997) MPEP § 2111.02. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. Shinhiko disclose reacting fullerene with a lipid (squalene) and the fullerene is preferably C60. Shinhiko disclose topical application for cosmetics and dispersed in water or an aqueous solvent such as a mixture of alcohol (e.g., organic solvent) and water (see page 3, para 19).
Shinhiko does not disclose the lipid is a fatty acid comprising the structural formula C8H16O2. of Subbiah et al. (US 20170258917) (hereinafter Subbiah et al.) disclose improving the solubility of therapeutic agents including mixing lipid with a lipofullerene (abstract).The lipid is a fatty acid which may comprise medium and short chain fatty acids (e.g., caprylic acid) (para 0026). Caprylic acid has formula C8H16O2. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one lipid squalene, for another (e.g., caprylic acid). Both Shinhiko and Subbiah et al. disclose improving the solubility of therapeutic agents with lipids and lipofullerene.
Subbiah et al. disclose administering pharmaceutical compositions that comprising therapeutic agent, fullerene and lipid (para 0007 and 0081-0082 and 0102).
Shinhiko does not disclose the lipofullerene comprises a structural formula [C60]x[C8H14O2]y wherein x is greater or equal to 1 and y is greater than or equal to 1.
Subbiah et al. disclose formula C8H16O2. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention through routine experimentation to include the unsaturated form of caprylic acid such that the lipofullerene formula would be [C60]x[C8H14O2]y wherein x is greater or equal to 1 and y is greater than or equal to 1. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
Shinhiko disclose wrinkle compositions that include alcohol and water but does not disclose MSM and/or DMSO.
Benjamin et al. (US 20110136210) (hereinafter Benjamin et al.) disclose use of methylsulfonylmethane (MSM) to modulate antimicrobial activity such as inhibit the activity of microorganisms (abstract). Benjamin et al. disclose that MSM is added to cosmetic products susceptible to microbial contamination which include skin repair products (e.g., wrinkles) (paras 0102-104). Benjamin et al. disclose that for topical administration, compounds can be mixed with a liquid delivery agent for administration locally. The agents used therapeutically (such as DMSO, MSM and/or other therapeutic compounds described) are readily soluble or suspendable in water, and as such this would be useful for delivery since water does not cause adverse biological tissue effects. This allows sufficiently high doses to be administered locally or systemically without secondary toxicity from the delivery vehicle (para 0138). Benjamin et al. disclose that the addition of MSM unexpectedly reduces the unpleasant odor normally experienced with DMSO and that DMSO and MSM formulations produce no perceptible odor after use (para 0169). Cosmetic products include skin repair products that include for wrinkles (see para 0102). With regards to the limitation that the activator is separately applied from the lipofullerene, the composition to a subject, this is regarded as intended use of the composition and given little patentable weight to a composition.
Claim 1 has been amended to recite lipofullerene as the first compound and the second one includes activator which is separated from the first compound of the lipofullerene. Newell et al. (US 20140013989) disclose that activator compositions are stored separately until activation (abstract). The composition would activate once it makes contact with the activator (para 0016). Therefore it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to store the lipofullerene separately from its activator until its activation at which point there would be contact of the two ingredients. The purpose of keeping separately is to prevent premature reaction with the activator which is a concept readily recognized in the prior art as taught by Faucher (US 2011007032) (para 0035).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include DMSO and MSM in the antiwrinkle formulations of Shinhiko. One would have been motivated to add to cosmetic products such as antiwrinkle formulations in order to inhibit the activity of microorganisms and DMSO/MSM are useful for delivery in water since there would be no secondary toxicity from the delivery vehicle. Furthermore, MSM in combination with DMSO reduces the odor of DMSO after use. One would have a reasonable expectation of success in combining Shinhiko and Benjamin et al. because both are directed to topical application and antiwrinkle cosmetic products.
DOUBLE PATENTING
5. 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 1-13, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 10293054 in view of Shinhiko (WO 2009113426) and further in view of Benjamin et al. (US 20110136210).
Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to lipofullerene compositions reacted with lipid. The differences are that the ‘054 patent discloses formular C18H34O2 (oleic acid fatty acid) C8H14O2 whereas the instant claims recite medium chain fatty acid and formula C8H14O2. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention through routine experimentation to include the unsaturated form of caprylic acid such that the lipofullerene formula would be [C60]x[C8H14O2]y wherein x is greater or equal to 1 and y is greater than or equal to 1.
Shinhiko disclose wrinkle compositions that include alcohol and water but does not disclose MSM and/or DMSO.
Benjamin et al. (US 20110136210) (hereinafter Benjamin et al.) disclose use of methylsulfonylmethane (MSM) to modulate antimicrobial activity such as inhibit the activity of microorganisms (abstract). Benjamin et al. disclose that MSM is added to cosmetic products susceptible to microbial contamination which include skin repair products (e.g., wrinkles) (paras 0102-104). Benjamin et al. disclose that for topical administration, compounds can be mixed with a liquid delivery agent for administration locally. The agents used therapeutically (such as DMSO, MSM and/or other therapeutic compounds described) are readily soluble or suspendable in water, and as such this would be useful for delivery since water does not cause adverse biological tissue effects. This allows sufficiently high doses to be administered locally or systemically without secondary toxicity from the delivery vehicle (para 0138). Benjamin et al. disclose that the addition of MSM unexpectedly reduces the unpleasant odor normally experienced with DMSO and that DMSO and MSM formulations produce no perceptible odor after use (para 0169).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include DMSP and MSM in the antiwrinkle formulations of Shinhiko. One would have been motivated to add to cosmetic products such as antiwrinkle formulations in order to inhibit the activity of microorganisms and DMSO/MSM are useful for delivery in water since there would be no secondary toxicity from the delivery vehicle. Furthermore, MSM in combination with DMSO reduces the odor of DMSO after use. One would have a reasonable expectation of success in combining Shinhiko and Benjamin et al. because both are directed to topical application and antiwrinkle cosmetic products.
RESPONSE TO ARGUMENTS
6. Applicant’s arguments with respect to the claim amendment of having a first compound and second compound separated from the first compound where the first includes lipofullerene and the second includes an activator have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The concept of keeping an activator separated was well known in the art and one would do so in order to avoid premature reaction with the activator.
CONCLUSION
7. 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.
CORRESPONDENCE
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANAH AL-AWADI/Primary Examiner, Art Unit 1615