DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Receipt and consideration of Applicant’s amended claim set and Applicant’s arguments/remarks submitted on November 19, 2025 are acknowledged.
All rejections/objections not explicitly maintained in the instant office action have been withdrawn per Applicant’s claim amendments and/or persuasive arguments. Applicant’s claim amendments have necessitated new grounds of rejections set forth below.
Status of the Claims
Claims 52-56, 58, 60, 61, and 63-69 are pending and under consideration in this action. Claims 1-51, 57, 59, 62, 70, and 71 are cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 19, 2025 has been entered.
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.
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 52-56, 58, 60, 61, and 63-67 are rejected under 35 U.S.C. 103 as being unpatentable over Altman et al. (Altman) (WO 2016/176633 A1; of record) and Philippon et al. (Philippon) (US 2016/0303017 A1; published Oct. 20, 2016).
Altman discloses a silk moisturizer comprising silk protein fragment compositions. The silk moisturizer can be used to address fine lines and wrinkles of the skin (para.0005). In an embodiment, Altman discloses a moisturizing composition including a silk solution, hyaluronic acid, an oil or butter, and a pH adjusting agent (para.0006). The compositions may be in the form of various personal care products, such as lotions, emulsions, lip balm, or sunscreen (para.00201).
With regards to Claims 52-54 and 58 the silk solution may include about 1% to about 10% (w/v) of pure silk fibroin-based protein fragments that are substantially devoid of sericin. The pure silk fibroin-based protein fragments have an average weight molecular weight ranging from about 6 kDa to about 16 kDa. In some embodiments, the pure silk fibroin-based protein fragments have a polydispersity of between about 1.5 and about 3.0 (para.0006-0007, 00139). In an embodiment, the silk solution has between about 10 ppm and about 300 ppm of lithium bromide residuals and between about 10 ppm and about 100 ppm of sodium carbonate residuals (para.0008).
The composition further comprises surfactants (para.00178).
In an embodiment, the composition comprises one or molecules, such as emulsifiers (para.0008).
In an embodiment, the compositions are stable water-in-oil (w/o) emulsions comprising water, oil, and silk protein fragment solutions. In an embodiment, the compositions are stable oil-in-water (o/w) emulsions comprising water, oil, and silk protein fragment solutions. The compositions are stable emulsions which do not undergo phase separation upon storage (para.00200).
With regards to Claim 55, Altman further discloses that the silk solution composition may include from about 0.1 wt.% to about 20 wt.% pure silk fibroin-based protein fragments (para.0008). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
With regards to Claim 56, the pure silk-fibroin-based protein fragments may be stable in the solution for at least 30 days. The term “stable” refers to the absence of spontaneous or gradual gelation, with no visible change in the color or turbidity of the solution (para.0008).
With regards to Claims 60 and 61, in an embodiment, Altman discloses a moisturizing composition including a silk solution, hyaluronic acid, an oil or butter, and a pH adjusting agent (para.0006; 00509).
With regards to Claim 63, Altman further discloses the inclusion of one or more emollients. Among the suitable emollients include fatty alcohols having 10 to 20 carbon atoms, such as cetyl alcohol (C16 fatty alcohol) (para.00154).
With regards to Claims 64 and 65, the moisturizing composition comprises an oil or butter, such as jojoba oil, rosehip oil, coconut oil, lemongrass oil, shea butter, glycerin, or a combination of two or more thereof (para.00168).
With regards to the Claims 66 and 67, the claims each depend from claim 52 which recite emulsifiable components for inclusion in the alternative. Claims 66 and 67 as currently written do not positively recite that the lipid is included but rather, merely recite specific lipids that may be included. Thus, claims 66 and 67 are interpreted as the composition further comprising an emulsifiable component wherein the emulsifiable component comprises one or more of an oil, a fat, a wax, a lipid, and combinations thereof, but if a lipid is included, then the lipid must be those specific recited in claim 66 or claim 67. As Altman’s composition includes an oil, fat, or wax as discussed above, Altman also reads on claims 66 and 67.
Altman does not appear to explicitly disclose a carrier comprising one or more components from those recited in claim 52. Philippon is relied upon for this disclosure. The teachings of Philippon are set forth herein below.
Philippon discloses a composition comprising, in a physiologically acceptable aqueous medium, at least one monosaccharide or a polysaccharide containing up to 6 sugar units, a polyol, and a betaine, said composition being free of potassium sorbate. Philippon is also directed to a cosmetic process for treating keratin materials by applying such a composition (abstract; para.0001-0002).
The aim of the invention is to provide a composition comprising water which has good stability, especially good microbiological stability, which is very well tolerated, with an aesthetic appearance (such as the color) and which remains pleasant to the consumer (para.0006). Philippon discloses that such a composition may be obtained by combining the aforementioned components. The composition was found to have good stability, especially after storage for several weeks at a temperature above 40oC, in particular good microbiological stability, with an aesthetic appearance, whose color remains pleasant to the consumer, while at the same time being very well tolerated (para.0007).
With regards to Claim 52, Philippon discloses that the composition comprises sucrose, 1,3-propane-diol, and cocoyl betaine (reading on cocobetaine) (para.0025). The composition was found to show good microbiological stability over time, have an aesthetic appearance, including an aesthetic color, and are stable after several weeks at 40oC. The combination of sucrose, 1,3-propanediol, and cocoyl betaine was shown to have very broad antimicrobial spectrum due to its antibacterial and antifungal activity (para.0122).
The composition may be in the form of a lotion, or in the form of an aqueous base of a two-phase formulation (para.0062). The composition may be a care composition, especially a care product for keratin materials, such as the skin, a care base for the skin, a face or scalp lotion, a lipcare composition (lip balm), or an antisun composition (para.0063).
With regards to Claim 52, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date to combine the teachings of Altman and Philippon and include Philippon’s composition (which comprises cocobetaine) into Altman’s moisturizer composition. One of ordinary skill in the art would have been motivated to do so in order to impart the advantage of providing good storage stability and good microbiological stability (both antibacterial and antifungal activity) into Altman’s aqueous compositions. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as both Altman and Philippon are directed to skin care compositions, e.g., lotion, and components suitable for such compositions, and Altman is directed to aqueous compositions (e.g., oil-in-water and water-in-oil emulsions), and Philippon discloses that their compositions are intended to provide the aforementioned advantageous properties for aqueous compositions, including those in the form of an aqueous base of a two-phase formulation.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claims 68 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Altman et al. (Altman) (WO 2016/176633 A1; of record) and Philippon et al. (Philippon) (US 2016/0303017 A1; published Oct. 20, 2016) as applied to claims 52-56, 58, 60, 61, and 63-67 further in view of Minga et al. (Minga) (US 2005/0232876 A1; of record).
The teachings of Altman and Philippon and the motivation for their disclosure as they apply to claims 52-56, 58, 60, 61, and 63-67 are set forth above and incorporated herein. As discussed above, Altman and Philippon both disclose that their compositions may be in the form of a lip balm or sunscreen (Altman para.00201; Philippon para.0063).
The combined teachings of Altman and Philippon does not appear to explicitly disclose the inclusion of a density matching agent or weighting agent as recited in the instant claim 68. Minga is relied upon for this disclosure. The teachings of Minga are set forth herein below.
Minga discloses skin care compositions comprising an admixture of sucrose acetate isobutyrate (SAIB) and certain diol and glycerol carboxylate esters. The compositions are useful as cosmetic, protective, and therapeutic dermatological compositions. The composition exhibit smoothness and water resistance when applied on the skin (abstract).
With regards to Claim 68, Minga discloses that they have discovered that the viscosity and tackiness problems that limit the utility of SAIB in skin care compositions can be overcome by blending certain glycerol triesters with SAIB. Such blends have been found to be useful in liquid skin care compositions wherein the blends exhibit smoothness when applied to human skin and excellent resistance to removal with water (para.0007).
These SAIB blends have a smooth-feel, spread and glide easily, and have a glossy appearance when applied to the skin. The blends can be easily incorporated into cosmetic formulations. As a component of a cosmetic composition, the SAIB/ester additive blends provide water resistance and transfer resistance to cosmetic skin care products and color cosmetics. In the case of skin and lip care products, the SAIB/ester additive blends can provide a protective barrier (para.0008). The SAIB component can function as a skin protectant in products such as skin moisturizers (para.0012).
With regards to Claim 69, the liquid skin care compositions typically comprise about 2-95 wt.% of the preblended SAIB/ester additives (para.0012). The weight ratio of SAIB:ester is in the range of about 80:20 to 70:30 (Minga claim 3).
The liquid skin care compositions may comprise an oil-in-water emulsion (para.0007).
The composition may be in the form a sunscreen, moisturizing cream, or lip product (para.0020, 0024, 0026).
With regards to Claim 68, as discussed above, Altman discloses that their moisturizing composition may be in the form of, for example lip balm or sunscreen. In light of the advantages that Minga’s SAIB blends provide for cosmetic and skin care products, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of Altman and Philippon with the teachings of Minga and include Minga’s SAIB blends in an amount disclosed by Minga (2-95 wt.% of the composition) into the cosmetic compositions (e.g., sunscreen or lip balm) of the combined teachings of Altman and Philippon. One of ordinary skill in the art would have been motivated to do so in order to impart the advantageous properties provided by Minga’s SAIB blends, e.g., providing a protective barrier, functioning as a skin protectant, providing water resistance and transfer resistance, and providing a smooth-feel, spread and glide easily, and have a glossy appearance when applied to the skin. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Altman and Philippon disclose their composition in the form of cosmetic formulations, and Minga discloses that their SAIB blends are suitable for inclusion into cosmetics in amounts ranging from 2-95 wt.% of the composition.
With regards to Claim 69 regarding the amount of the SAIB in the composition, as discussed above, Minga discloses that the SAIB blend (SAIB/ester additive) may be included in an amount ranging from 2-95 wt.% and the weight ratio of SAIB:ester is in the range of about 80:20 to 70:30. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Response to Arguments
Applicant's arguments filed November 19, 2025 have been fully considered. In light of Applicant’s claims amendments, new rejections citing new combinations of references are set forth above to address the claims as amended.
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 52-56, 58, 60, 61, and 63-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over (i) claims 1-34 of U.S. Patent No. 11,878,070 B2 (USPN 070) and (ii) claims 1-20 of U.S. Patent No. 12,447,122 B2 (USPN 122) in view of Minga et al. (Minga) (US 2005/0232876 A1; of record) and Philippon et al. (Philippon) (US 2016/0303017 A1; published Oct. 20, 2016).
Although the claims at issue are not identical, they are not patentably distinct from each other because all cited sets of claims claim substantially similar silk personal care compositions as recited in the instant claim 52.
The primary differences between the instant claims and the claims of USPN 070/USPN 122 are: (i) USPN 070/USPN 122 does not appear to explicitly claim the inclusion a carrier comprising one or more components from those recited in claim 52; or (ii) USPN 070/USPN 122 does not appear to explicitly claim the inclusion of a density matching agent or weighting agent as recited in the instant claim 68. These differences are prima facie obvious modifications in light of Minga and Philippon, whose teachings are set forth above and incorporated herein.
With regards to difference (i), USPN 070/USPN 122 claim topically applied moisturizing composition, which are in the form of an emulsion. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date to combine the claims of USPN 070/USPN 122 with the teachings of Philippon and include Philippon’s composition (which comprises cocobetaine) into USPN 070/USPN 122’s claimed moisturizing composition, which includes water. One of ordinary skill in the art would have been motivated to do so in order to impart the advantage of providing good storage stability and good microbiological stability (both antibacterial and antifungal activity) into USPN 070/USPN 122’s aqueous compositions. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as both USPN 070/USPN 122’s claimed composition and Philippon’s disclosure are directed to skin care compositions, e.g., lotion, and components suitable for such compositions, and USPN 070/USPN 122’s claims are directed to aqueous compositions, and Philippon discloses that their compositions are intended to provide the aforementioned advantageous properties for aqueous compositions, including those in the form of an aqueous base of a two-phase formulation.
With regards to difference (ii), USPN 070/USPN 122 claims topically applied moisturizing compositions. In light of the advantages that Minga’s SAIB blends provide for cosmetic and skin care products, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the claims of USPN 070/USPN 122 and teachings of Philippon with the teachings of Minga and include Minga’s SAIB blends in an amount disclosed by Minga (2-95 wt.% of the composition) into the composition of the combined USPN 070/USPN 122 claims and teachings of Bellas. One of ordinary skill in the art would have been motivated to do so in order to impart the advantageous properties provided by Minga’s SAIB blends, e.g., providing a protective barrier, functioning as a skin protectant, providing water resistance and transfer resistance, and providing a smooth-feel, spread and glide easily, and have a glossy appearance when applied to the skin. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as USPN 070/USPN 122 claims their composition in the form of topical formulations, and Minga discloses that their SAIB blends are suitable for inclusion into cosmetics in amounts ranging from 2-95 wt.% of the composition.
Further regarding the amount of the SAIB in the composition, as discussed above, Minga discloses that the SAIB blend (SAIB/ester additive) may be included in an amount ranging from 2-95 wt.% and the weight ratio of SAIB:ester is in the range of about 80:20 to 70:30. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Claims 52-56, 58, 60, 61, and 63-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over (i) claims 1, 2, 7, 8, 14-25, 48-51 of copending Application No. 17/604,192 (Copending 192) further in view of Minga et al. (Minga) (US 2005/0232876 A1; of record) and Philippon et al. (Philippon) (US 2016/0303017 A1; published Oct. 20, 2016).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the cited sets of claims claim substantially similar silk personal care compositions as recited in the instant claim 52.
The primary differences between the instant claims and the claims of Copending 192 are: (i) Copending 192 does not appear to explicitly claim the inclusion a carrier comprising one or more components from those recited in claim 52; and (ii) Copending 192/Copending 431 does not appear to explicitly claim the inclusion of a density matching agent or weighting agent as recited in the instant claim 68. These differences are prima facie obvious modifications in light of Minga and Philippon, whose teachings are set forth above and incorporated herein.
With regards to difference (i), Copending 192 claims topically applied emulsion compositions. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date to combine the claims of Copending 192 with the teachings of Philippon and include Philippon’s composition (which comprises cocobetaine) into Copending 192’s claimed composition, which includes water. One of ordinary skill in the art would have been motivated to do so in order to impart the advantage of providing good storage stability and good microbiological stability (both antibacterial and antifungal activity) into Copending 192’s aqueous compositions. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as both Copending 192’s claimed composition and Philippon’s disclosure are directed to care compositions, e.g., lotion, and components suitable for such compositions, and Copending 192’s claims are directed to aqueous compositions, and Philippon discloses that their compositions are intended to provide the aforementioned advantageous properties for aqueous compositions, including those in the form of an aqueous base of a two-phase formulation.
With regards to difference (ii), Copending 192 claims topically applied compositions. In light of the advantages that Minga’s SAIB blends provide for cosmetic, skin, and hair care products (Minga claim 9), one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the claims of Copending 192/Copending 431 and teachings of Philippon with the teachings of Minga and include Minga’s SAIB blends in an amount disclosed by Minga (2-95 wt.% of the composition) into compositions of the combined claims of Copending 192/Copending 431 and teachings of Philippon. One of ordinary skill in the art would have been motivated to do so in order to impart the advantageous properties provided by Minga’s SAIB blends, e.g., providing a protective barrier, functioning as a skin protectant, providing water resistance and transfer resistance, and providing a smooth-feel, spread and glide easily, and have a glossy appearance when applied to the skin. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Copending 192/Copending 431 claims their composition in the form of topical formulations, and Minga discloses that their SAIB blends are suitable for inclusion into cosmetics in amounts ranging from 2-95 wt.% of the composition.
Further regarding the amount of the SAIB in the composition, as discussed above, Minga discloses that the SAIB blend (SAIB/ester additive) may be included in an amount ranging from 2-95 wt.% and the weight ratio of SAIB:ester is in the range of about 80:20 to 70:30. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed November 19, 2025 have been fully considered. Applicant requests the double patenting rejections of the pending claims be held in abeyance until such claims are found allowable. Thus, the double patent rejections set forth above and maintained at this time.
Conclusion
Claims 52-56, 58, 60, 61, and 63-69 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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/MONICA A SHIN/Primary Examiner, Art Unit 1616