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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/EP2018/080557 filed 11/08/2018, which claims the benefit of the priority of European Patent Application No. 17201049.8 filed 11/10/2017.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1, 3, 5, 10, 12, 16-23, 26-27, 30-32, 35, 37-43, 47- 56, and 59 are pending. Claims 2, 4, 6-9, 11, 13-15, 24-25, 28-29, 33-34, 36, 44-46, 57-58 are canceled. Claims 1 is amended. Claims 16-23, 26-27, 30-32, 35, 37-43, 47-54, 56, and 59 are withdrawn. Claims 1, 3, 5, 10, 12, and 55 are being examined on the merits in this office action.
Claim Rejections - 35 USC § 103 - Maintained
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.
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.
Claim(s) 1, 3, 5, 10, 12, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Kiyoichi et al. (JPH04300897A – hereinafter “Kiyoichi”) as evidenced by Wigham et al. (Soft Matter, 2025, 21, 2461), in view of Akiho et al. (JP2008169171A – hereinafter “Akiho”), Altman et al. (US20110020409A1 – hereinafter “Altman”), and Liebmann et al. (US20100278882A1 – hereinafter “Liebmann”) – All references attached in previous office action.
Kiyoichi teaches a composition that comprises silk fibroin, alcohol and water, wherein the alcohol is methanol, ethanol, or isopropyl alcohol [0006], wherein the mixing ratio of methanol and water or ethanol and water is from {50:50} to 98: 2 and that silk fibroin is in a concentration up to 20% (Page 1). Examiner notes that as evidenced by Wigham et al., silk fibroin is a silk protein that self assembles (See abstract). Wigham teaches silk fibroin has a molecular weight of about 100 kDa (Page 2468). Kiyoichi teaches that the composition obtained was transparent composition [0008], which reads on clear.
Similarly, Akiho teaches an aqueous cosmetic composition comprising from 5% silk fibroin, a lower aliphatic alcohol and water (Abstract; Page 2,), wherein the alcohol is preferably methyl alcohol, ethyl alcohol, or propyl alcohol, wherein the alcohol / water mixing ratio is preferably greater than 1 but is particularly preferably 5/5 to 10/0 (Page 2, 6th paragraph). Examiner notes that the range of alcohol and water ration encompasses the instant concentration of 60-90% alcohol and 5-39% water.
Furthermore, Altman teaches a silk fibroin hydrogel that comprises silk fibroin at a concentration of 1-10% (Abstract; claim 2), and that the composition further comprises 10% water and 90% ethanol [0013, 0029, 0085-0086]. Altman teaches that the formulation exhibits a dynamic viscosity [0124] and further that dynamic viscosity is also known as complex viscosity [0125] and further that the viscosity is about 10 Pas or about 20 Pas or about 30 Pas [0128]. Altman teaches that the hydrogel exhibited optical properties such as transparency [0111-0013, 0203], which reads on clear. Altman further teaches silk hydrogel formulations for cosmetic use [0155,0176]. Altman further teaches that the silk hydrogel formulation was successful in improving the condition of the skin in an individual in need thereof [0156].
Kiyoichi does not teach that the composition is a fragrance or oil fragrance.
Liebmann teaches a cosmetic composition for skin cosmetic, nail cosmetic, hair cosmetic, dermatological, or hygiene, that the composition can be in form of a gel, and that the composition comprises perfume oils [0119-0122]. Liebmann teaches that the composition comprises a silk protein microbead, specifically a C16 silk protein [0019-0021], and that the composition further comprises alcohol such as ethanol and water [0083, 0325]. Liebmann teaches that the composition remained clear [0220, 0270, 0272, 0290, 0292, 0298]. Liebmann teaches that the silk protein has the polypeptide sequence shown in SEQ ID NO: 1 and includes functional equivalents, functional derivatives and salts of this sequence [0021-0022], and the sequence comprises the instant sequence of SEQ ID NO: 1.
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 teachings of Kiyoichi and include fragrance oil or perfume oil in the composition since both reference teach similar composition with silk protein, alcohol and water and for use as a cosmetic composition. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in including perfume or fragrance oil in the composition since Liebmann teaches that such compositions that comprises silk protein, alcohol and water can also include fragrance oils and for use as a cosmetic composition.
Additionally, one of ordinary skill in the art would have had a reasonable expectation of successfully combining the cited prior art teachings of Kiyoichi, Akiho, Altman and Liebmann , because the cited references hail from the same field of endeavor, i.e. aqueous cosmetic compositions that comprise silk, alcohol and water. The disclosure renders obvious claim 1.
Regarding claim 2, Kiyoichi teaches a composition that comprises silk fibroin, alcohol and water, wherein the alcohol is methanol, ethanol, or isopropyl alcohol [0006], wherein the mixing ratio of methanol and water or ethanol and water is from {50:50} to 98: 2 and that silk fibroin is in a concentration up to 20% (Page 1). Examiner notes that the concentrations of Kiyoichi encompass the instant concentrations of claim 2 rendering obvious the claim.
Regarding claim 5, Kiyoichi teaches a composition that comprises silk fibroin, alcohol and water, wherein the alcohol is methanol, ethanol, or isopropyl alcohol [0006], wherein the mixing ratio of methanol and water or ethanol and water is from {50:50} to 98: 2 and that silk fibroin is in a concentration up to 20% (Page 1). Examiner notes that as evidenced by Wigham et al., silk fibroin is a silk protein that self assembles (See abstract). Wigham teaches silk fibroin has a molecular weight of about 100 kDa (Page 2468). Further, Akiho teaches molecular weight of about 10,000 to 30,000 (Page 1, 6th paragraph), which reads on 10-30 Kda.
Regarding claim 10, Altman teaches that the silk protein may be recombinant [0056]. It would have been obvious to modify Kiyoichi and use a recombinant silk protein as taught by Altman.
Regarding claim 12, Liebmann teaches that the silk protein has the polypeptide sequence shown in SEQ ID NO: 1 and includes functional equivalents, functional derivatives and salts of this sequence [0021-0022], and the sequence comprises the instant sequence of SEQ ID NO: 1. It would have been obvious to use the silk protein sequence of Liebmann to prepare the cosmetic composition that comprises silk, alcohol and water since Liebmann teaches that the composition contributed to the moisturization and conditioning of the skin and to an improvement in the feel of the skin [0154].
Regarding claim 55, the Examiner notes that the cited references render obvious a composition comprising the protein, alcohol and water at the recited dosages. Examiner notes that claim 55 is a product-by-process type claim. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113. Claim 55 is drawn to the aqueous formulation, pharmaceutical and cosmetic formulation of claim 1, and that the formulation is formed by combining the aqueous solutions comprising the structural protein and the aqueous solution comprising the alcohol simultaneously, and wherein the aqueous solutions are mixed for no more than 10 seconds. The formulation is not affected by these limitations, which merely reflect one version of a process that could be used to make the product. The product or formulation could be made in other ways; thus, the limitations do not add patentable weight to the claims. If the product in these claims is the same as or obvious from a product of the prior art, the claim is unpatentable. The formulation comprising silk protein, alcohol, and water and in the recited amounts is clearly disclosed by Kiyoichi, Akiho, Altman and Liebmann. Kiyoichi teaches a composition that comprises silk fibroin, alcohol and water, wherein the alcohol is methanol, ethanol, or isopropyl alcohol [0006], wherein the mixing ratio of methanol and water or ethanol and water is from {50:50} to 98: 2 and that silk fibroin is in a concentration up to 20% (Page 1). Kiyoichi teaches that the composition obtained was transparent composition [0008], which reads on clear. Further, Akiho, Altman and Liebmann teach a similar composition. Thus, claim 55 is rejected as unpatentable over the cited references.
Response to Arguments
Applicant's arguments filed 08/12/2026 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that the prior art should be dismissed because the references do not teach cosmetic composition and that the claims are drawn to a cosmetic composition (Page 1-2 of Applicant arguments).
Applicant argues that Kiyoichi and Akiho does not disclose or suggest that the composition is relevant to a 'cosmetic composition' nor does Kiyoichi disclose each of the limitations (a) - (e) (Page 3-5 of Applicant arguments).
Applicant further argues that Altman is technically divergent field from cosmetic compositions as is now claimed because it teaches an injectable dermal filler (Page 5-6 of Applicant arguments).
Applicant argues that that the disclosures of Liebmann are inadequate to render the currently claimed invention as being obvious, whether Liebmann is considered singly or jointly and does not teach all the limitations of the claimed invention and that the reference appears to address a different technical problem than that relevant to the presently claimed invention, namely of providing a method for coupling of "effector molecule(s)" to the protein of his silk protein microbeads (Page 7-8 of Applicant arguments).
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that Applicant arguments that the cited references do not teach cosmetic composition is unpersuasive. Examiner notes that all the cited references teach a composition that comprises silk, alcohol and water and the references teach the cited concentrations. Additionally, Akiho, Altman and Liebmann teach that the composition is or can be used as a cosmetic composition. Applicant arguments that the cited references do not teach cosmetic composition are unpersuasive.
Further, Applicant argument that the references do not teach the limitations (a) - (e) is unpersuasive because the primary reference Kiyoichi teaches a composition that comprises silk fibroin, alcohol and water, wherein the mixing ratio of methanol and water or ethanol and water is from {50:50} to 98: 2 and that silk fibroin is in a concentration up to 20%. The silk fibroin of Kiyoichi is known in the art to have a MW of about 100 kDa. Kiyoichi teaches that the composition obtained was transparent composition [0008], which reads on clear. Akiho teaches an aqueous cosmetic composition comprising from 5% silk fibroin, a lower aliphatic alcohol and water (Abstract; Page 2), wherein the alcohol is preferably methyl alcohol, ethyl alcohol, or propyl alcohol, wherein the alcohol / water mixing ratio is preferably greater than 1, but is particularly preferably 5/5 to 10/0. Altman teaches a silk fibroin hydrogel that comprises silk fibroin at a concentration of 1-10% (Abstract; claim 2), and that the composition further comprises 10% water and 90% ethanol, and further that the viscosity is about 10 Pas or about 20 Pas or about 30 Pas. Altman teaches that the hydrogel exhibited optical properties such as transparency. Liebmann teaches a cosmetic composition for skin cosmetic, nail cosmetic, hair cosmetic, dermatological, or hygiene, that the composition can be in form of a gel, and that the composition comprises perfume oils [0119-0122]. Liebmann teaches that the composition comprises a silk protein microbead, specifically a C16 silk protein [0019-0021], and that the composition further comprises alcohol such as ethanol and water. Examiner notes that the cited references teach all the limitations of the claimed invention. Additionally, in response to this argument, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is acknowledged that primary reference Kiyoichi does not teach the addition of fragrance or perfume oils in a composition that comprises silk, alcohol and water. However, Liebmann teaches a composition that comprises silk, alcohol and water and teaches that the composition can comprise fragrance oils. Examiner notes that the instant claims only require that the composition comprise silk, alcohol and water in the recited concentrations, that the composition comprise fragrance oil, has the recited viscosity and has a clear appearance. All the limitations of independent claim 1 are taught by the cited references. Examiner notes that one of ordinary skill in the art has a choice of having the composition for topical administration as taught by Kiyoichi, Akiho and Liebmann, or as an injectable as taught by Altman. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Thus, the Examiner maintains that when the teachings of the references are combined, the claimed invention is rendered obvious.
With regards to Applicant argument that the Wigham reference is unavailable prior art, Examiner notes that the reference was used as an evidentiary reference to state what is known in the art with regards to the silk fibroin, the protein is known to self-assemble. In certain circumstances, references cited to show a universal fact need not be available as prior art before applicant’s filing date. In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a material or a scientific truism…However, it is impermissible to use a later factual reference showing the state of the art existing after the effective filing date of the application to determine whether the application is enabled or described as required under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Koller, 613 F.2d 819, 823 n. 5, 204 USPQ 702, 706 n.5 (CCPA 1980). See MPEP 2124. The arguments are unpersuasive.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
