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 .
Status of Claims
The amendments and arguments filed 24 June 2025 are acknowledged and have been fully considered. Claims 23-36 and 43-51 currently pending. Claims 23-24, 26-29, 31, 33, and 35 are amended; claims 1-22 and 37-42 are cancelled; claims 24-25, 29-36, and 43-48 are withdrawn; claims 49-51 are new.
Claims 23, 26-28, and 49-51 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular, the rejection of claims under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendment to the claims. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
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 23, 26-28, and 49-51 are rejected under 35 U.S.C. 103 as being unpatentable over Foldvari et al. (US 2013/0224283; of record) in view of Foldvari (Journal of Biomedical Nanotechnology, 2010, Vol. 6, 1-15 cited on Applicant’s IDS filed 26 November 2024), hereinafter Foldvari 2010, as evidenced by Lipoid (“Soybean Phospholipids & Formulations”; of record), Lesielle (“Albumin”), and Hutapea et al. (Journal of Science: Advanced Materials and Devices, 2023, Vol. 8, 100549).
Claim 23 is drawn to a composition for producing a cosmetic effect comprising:
an active ingredient comprising a molecular weight of about 20 kD to about 500 kD (more specifically about 50 kD to about 250 kD (Claims 49-50)) entrapped in an oil-in-water emulsion;
vesicle forming lipids encapsulating portions of the oil-in-water emulsion; and
a sterol (more specifically cholesterol (Claim 28, Applicant’s elected species)), wherein a ratio of the percentage of the sterol to the vesicle forming lipids in the composition is about 1:4.
Foldvari et al. teach biphasic vesicle compositions (Abstract) including Formulation Q25 C (Table 1 on Pgs. 4-5), comprising:
interferon alpha-2b drug substance;
100 mg/g Phospholipon 90H; and
20 mg/g cholesterol.
Foldvari et al. further teach the interferon alpha-2b being included in an oil-in-water emulsion phase that is then encapsulated in the mixture of Phospholipon 90H and cholesterol (Pars. [0049-0052]).
As evidenced by Lipoid, Phospholipid comprises soybean phospholipids.
As such, Foldvari et al. teach a composition comprising an active ingredient entrapped in an oil-in-water emulsion; vesicle forming lipids comprising phospholipids encapsulating portions of the oil-in-water emulsion; and cholesterol.
The composition of Foldvari et al. differs from the instantly claimed composition in the following ways:
the composition of Foldvari et al. does not comprise an active ingredient having a molecular weight of about 50 kD to about 250 kD;
the composition of Foldvari et al. does not comprise a 1:4 ratio of cholesterol to vesicle forming lipids; and
Foldvari et al. are silent as to the production of a cosmetic effect.
Yet, as to 1: Foldvari 2010 teaches biphasic vesicles as a topical delivery system (Abstract) of many different active ingredients, including albumin having a molecular weight of 60 kD (Table I on pg. 6, Pg. 11 left column first paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Foldvari et al. to encapsulate albumin. It would have been obvious to substitute one active ingredient suitable for topical delivery via biphasic vesicles for another, with a reasonable expectation of success.
As to 2: Foldvari et al. further teach the vesicles forming lipids in an amount of 60-200 mg/g and cholesterol in an amount of 2-40 mg/g (Table 1), corresponding to a cholesterol: phospholipid ratio of between 1:100 to 2:3 as calculated by examiner, overlapping with the instantly claimed range. Additionally, Foldvari et al. teach that cholesterol is added to strengthen the bilayers (Par. [0028]), indicating that the amount of cholesterol present in the bilayer directly impacts the structure and stability of the bilayers.
And, as discussed by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454)): “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the concentration of cholesterol is clearly a result-effective variables, determining the structure and stability of the bilayers. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal concentration of cholesterol in order to best achieve the desired results.
And, as to 3: The recitation of “for producing a cosmetic effect” is a statement of intended use of the composition and, as such does not impose any further limitations on the composition (see MPEP 2111.02).
Nevertheless, as taught by Foldvari 2010, biphasic vesicles encapsulating albumin are capable of penetrating into the skin (Pg. 11 left column first paragraph). And as evidenced by Lesielle, albumin “makes skin appear smoother, deals with the fine lines and wrinkles, and also improves skin tone” (Pg. 1).
Therefore, the biphasic vesicle composition encapsulating albumin taught by Foldvari et al. and Foldvari 2010 is capable of being used to produce a cosmetic effect.
Based on all of the foregoing, claims 23, 28, and 49-50 are rejected as prima facie obvious.
Claim 26 is drawn to the composition of claim 23, wherein the vesicle forming lipids are present in an amount of greater than 10%.
The vesicle forming lipids in composition Q25 C of Foldvari et al. are present in an amount equal to 10% by weight. However, Foldvari et al. further teach in Table 1 the vesicle forming lipids (Phospholipon 90H) being present in an amount of 60-200 mg/g, corresponding to a range of 6% to 20% by weight, overlapping with the instantly claimed range.
As such, claim 26 is rejected as prima facie obvious.
Claim 27 is drawn to the composition of claim 23, wherein the vesicle forming lipids comprise phospholipids, glycolipids, lecithins, ceramides, lysolecithin, lysophosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, sphingomyelin, cardiolipin, phosphatidic acid, cerebroside, or any combination thereof.
Foldvari et al. further teach the liposome-forming component comprising phospholipids, glycolipids, lecithins, ceramides, lysolecithin, lysophosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, sphingomyelin, cardiolipin, phosphatidic acid, cerebroside, or combinations thereof (Par. [0026]).
As such, claim 27 is rejected as prima facie obvious.
Claim 51 is drawn to the composition of claim 23, wherein the active ingredient is water-soluble.
Foldvari et al. and Foldvari 2010 are silent as to the solubility of albumin. However, as evidenced by Hutapea et al., albumin is a water-soluble protein (Abstract).
As such, claim 51 is rejected as prima facie obvious.
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 23 and 49-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40, 42, and 44 of copending Application No. 18/473,071 in view of Foldvari 2010.
Claim 40 of Application ‘071 recites a composition for delivering an active ingredient to a lip of a subject, comprising (a) an active ingredient entrapped in an oil-in-water emulsion; (b) vesicle forming lipids encapsulating portions of the oil-in-water emulsion; and (c) a short chain polyol stabilizing the vesicle forming lipids. Claims 42 and 44 of Application ‘071 recite the composition of claim 40 further comprising a sterol, wherein the ratio of the sterol to the vesicle forming lipids is about 1:4.
Application ‘071 does not recite the active ingredient having a molecular weight of about 25 kD to about 500 kD. However, Foldvari 2010 teaches similar biphasic vesicle compositions for topical delivery of active ingredients (Title), including albumin having a weight of 60 kD. It would have been prima facie obvious to a person having ordinary skill in the art to substitute albumin for the active ingredient in the composition of Application ‘071, as both active ingredients are taught to be suitable for delivery by biphasic vesicle systems.
As such, Claims 40, 42, and 44 of Application ‘071 in view of Foldvari 2010 overlap with instant claims 23 and 49-51.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 24 June 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 6 of the remarks that there is no teaching in Foldvari et al. to modify the composition for the purpose of producing a cosmetic effect.
This argument is not persuasive. The recitation of “for producing a cosmetic effect” in claim 23 is merely a recitation of intended use and does not further limit the claim (See MPEP 2111.02). Further, as discussed in MPEP 2144(IV), The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). As such, it is not necessary that Foldvari et al. provide a motivation to modify the produce a cosmetic effect.
Applicant argues on pg. 6 of the remarks that Foldvari et al. does not teach the particular ratio of 1:4 for sterol to vesicle forming lipids, suggesting that the ranges taught by Foldvari et al. are so broad as to not invite optimization by one of skill in the art, citing MPEP 2144.05(III)(D).
This argument is not persuasive. As discussed in MPEP 2144.05(II)(A), Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.).
Foldvari et al. teach that cholesterol is added to strengthen the bilayers (Par. [0028]), indicating that the amount of cholesterol present in the bilayer directly impacts the structure and stability of the bilayers. As such, optimization of the amount of cholesterol in the composition within the range taught by Foldvari et al. is well within the skill and normal desire of one of ordinary skill in the art in order to obtain the optimal bilayer. Optimization of the concentration of cholesterol in the composition would necessarily result in the optimization of the ratio of sterol to vesicle forming lipids.
Further, as discussed in MPEP 2144.05(III)(D), One factor that may weigh against maintaining an obviousness rejection based on optimization of a variable disclosed in a range in the prior art is where an applicant establishes that the prior art disclosure of the variable is within a range that is so broad in light of the dissimilar characteristics of the members of the range as to not invite optimization by one of skill in the art (emphasis added). As Applicant has not established that members of the ranges taught by Foldvari et al. have dissimilar characteristics, the ranges are not considered so broad as to not invite optimization.
Applicant argues on pg. 7 of the remarks that Foldvari et al. do not teach the active ingredient having a molecular weight of about 20 kD to about 500 kD.
This argument is moot in view of the new grounds of rejection set forth above necessitated by Applicant's amendment.
Conclusion
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.
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611