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 .
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 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.
DETAILED ACTION
Claims 1, 2, 4, 5, 9, 10, 13, 15-17, 20-22, 25, 26, and 28-32 are pending, claims 3, 6-8, 11, 12, 14, 18, 19, 23, 24, 27, and 33 are canceled in this application. This application is a national stage entry of PCT/US2022/079160, filled on 11/02/2022. This application claims priority to provisional application 63/274,837, filed on 11/02/2021 and to provisional application 63/302,793, filed on 01/25/2022.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, 9, 10, 13, 15-17, 20-22, 25, 26, and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wray et al. (WO 2021/011431 A1).
Wray et al. meet all of the limitations of claims 1, 2, 4, 5, 9, 10, 13, 15-17, 20-22, 25, 26, and 29-31.
Wray et al. disclose recombinant silk proteins being disclosed in US 2018/0111970 and U.S 2018/0057548 (paragraph 95) which is the same as the instant specification in paragraph 90. Thus, the recombinant silk proteins taught by Wray et al. would include the recombinant silk proteins having the claimed SEQ ID No. 1.
Wray et al. disclose a spider silk cosmetic or skincare (the instant claim 1) product comprising an extrudate (claims 37 and 49) comprising a
a recombinant silk protein in powder form (the instant claim 4), serum (the instant claim 26) (paragraph 156) and glycerol as a plasticizer (a humectant, the claimed active in the instant claim 1) (claims 37, 43, 48, and 49), and
exemplified a composition comprising 5% by weight of recombinant silk protein (the claimed loading level in the instant claims 2, 13, and 17, and thus, with Wray et al. not disclosing inclusion of silicone, as a silicone replacement in the instant claim 1, providing the effect of in the instant claim 2, and viscosity effect in comparison to silicone in the instant claim 15) in example 15;
wherein said extrudate is suspended in an aqueous solvent (the instant claims 5, 9, 16, and 29-31) in a gel (the instant claim 10) (claims 37 and 49);
wherein the length of the recombinant silk protein is >150 amino acids (the instant claim 20) (paragraph 111);
wherein said recombinant silk protein forms beta-sheet structures (physical crosslinking, the instant claim 22) (paragraph 116) has increased crystallinity as compared to the recombinant silk protein in powder form (the instant claim 21) (claim 48).
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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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, 2, 4, 5, 9, 10, 13, 15-17, 20-22, 25, 26, and 29-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wray et al. (WO 2021/011431 A1) in view of Widmaier et al. (US 2016/0222174 A1).
The reference of Wray et al. is described in detail above and that discussion is hereby incorporated by reference. It is recognized that the teachings of Wray et al. were deemed to anticipate the claims in the preceding ground of rejection. The instant ground of rejection applies an alternative interpretation of the Wray et al., which alternative interpretation is in expectation of an argument that applicant could make regarding whether the recombinant silk proteins disclosed by Wray et al. include the claimed SEQ ID No. 1 in the instant claim 25, i.e. that the disclosure of Wray et al. is not explicit enough to support an anticipation determination with regard to the recombinant silk proteins disclosed by Wray et al. including the claimed SEQ ID No. 1 in the instant claim 25. The Examiner does not agree with such a view, but nonetheless, this alternative ground of rejection is set forth to provide an alternative rationale as to the recombinant silk proteins disclosed by Wray et al., even if they do not anticipate the claimed invention, nonetheless provide ample disclosure, suggestion and motivation for one of ordinary skill in the art to have arrived at the claimed invention:
Widmaier et al. teach recombinant silk protein having the claimed SEQ ID No. 1 in the instant claim 25 is known as recombinant silk protein having the claimed SEQ ID No. 1 (paragraph 40 and the submitted sequence, attached as OA.Appendix).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Wray et al. and Widmaier et al. to specify the recombinant silk protein in the composition taught by Wray et al. having the claimed SEQ ID No. 1. Recombinant silk protein having the claimed SEQ ID No. 1 in the instant claim 25 was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Claims 1, 2, 4, 5, 9, 10, 13, 15-17, 20-22, 25, 26, and 28-32 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wray et al. (WO 2021/011431 A1) in view of Katz (US 2005/0232957 A1).
The teachings of Wray et al. are discussed above and applied in the same manner. Wray et al. teach the composition comprising phenoxyethanol (paragraph 218).
Wray et al. do not specify the composition comprising sodium benzoate in the instant claim 28 and dye in the instant claim 32.
This deficiency is cured by Katz who teaches a topical skin moisturization composition (abstract) comprising coloring agents such as a dye (paragraph 58) and preservatives including phenoxyethanol and sodium benzoate (paragraph 61 and 63).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Wray et al. and Katz to add a dye to in the composition taught by Wray et al. and replace phenoxyethanol in the composition taught by Wray et al. with sodium benzoate. A topical skin moisturization composition comprising a dye and preservatives including phenoxyethanol and sodium benzoate was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for adding a dye to in the composition taught by Wray et al. and replacing phenoxyethanol in the composition taught by Wray et al. with sodium benzoate flows from incorporating a dye in a topical skin moisturization composition and both phenoxyethanol and sodium benzoate being suitable preservatives in a topical skin moisturization composition having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose.
Claims 1, 2, 4, 5, 9, 10, 13, 15-17, 20-22, 25, 26, and 28-32 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wray et al. (WO 2021/011431 A1) in view of Widmaier et al. (US 2016/0222174 A1) and Yoneda et al. (US 2008/0311234 A1).
The teachings of Wray et al. and Widmaier et al. are discussed above and applied in the same manner.
Wray et al. do not specify the composition comprising sodium benzoate in the instant claim 28 and dye in the instant claim 32
This deficiency is cured by Yoneda et al. whose teachings and the rationale discussed above and applied in the same manner.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 2, 4, 5, 9, 10, 13, 15-17, 20-22, 25, 26, and 28-32 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 2 of copending Application No. 19/060, 145 in view of Widmaier et al. (US 2016/0222174 A1). Although the patent and instant claims are not identical, they are not patentably distinct from each other in view Widmaier et al. whose teachings and the rationale discussed above and applied in the same manner.
Although the patent and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same composition.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
Prosecution Insights