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 .
DETAILED ACTION
Response to Amendment
As a result of the amendments to the claim, the 112(b) rejection over Claims 1-9 have been withdrawn.
All rejections not repeated in this Office Action have been withdrawn.
Claims 1-7, and 9-12 are currently pending in this Office Action. Claims 10-12 have been withdrawn due to being drawn to the non-elected invention.
Claim Objections
Claims 10-12 objected to because of the following informalities: the claim status should be indicated as “Withdrawn” due to the election of Group I, Claims 1-9 as submitted in the remarks filed 3/11/2025. Appropriate correction is required.
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.
Claim(s) 1, 2, 4, 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (KR 20190054544 A- see machine translations- previously cited) in view of Vepari et al. (Silk as a Biomaterial- previously cited).
Regarding Claims 1, 2, 7, Choi discloses a meat substitute composition (meat, sausage, See page 4, fourth paragraph) comprising:
a food product (the silk protein may be added to the food composition (page 4, fourth paragraph);
a fibroin (silkworm derived fibroin, see abstract, meets the limitations of Claim 7), which is construed to satisfy (1) or (2) (Claim 7 recites that the polypeptide is fibroin), and wherein the polypeptide is in the form of a fiber. That is, the term “silk” means a fiber produced by insect (page 3, third paragraph); therefore, the term “silk fibroin” is construed to be fibroin in the form of fiber. Alternatively, While Choi does not specifically recite the particular amino acid residues, Choi discloses that the silkworm fiber is derived from Bombyx mori (Page 2, third paragraph of the translations), where Vepari discloses that silk fiber from silkworm (Bombyx mori) is primarily glycine (43%), alanine (30%), and serine (12%), (see page 2, section 2.1 B.mori silk fibroin structure) thereby meeting the limitations of (1) and (2) (As required by Claim 2). Vepari notes that silks from silkworms represent a unique family of structural proteins that are biocompatible, degradable, and mechanically superior, offer a wide range of properties, are amenable to aqueous or organic solvent processing, and chemically modifiable (see page 2, third paragraph).
Therefore, since Choi both Choi and Vepari are directed to silk fibroin derived from silk worm, and specifically Bombyx mori, it would have been obvious to one of ordinary skill in the art to use conventional fibroin materials taught by Vepari for the purpose of using structural proteins that are biocompatible, degradable, and for its wide range of properties.
Regarding Claim 4, Vepari further teaches wherein the polypeptide has a plurality of repeating sequence units and the repeating sequence units each have 42-44 amino acid residues (“the less crystalline forming regions of the fibroin heavy chain, also known as linkers, are between 42–44 amino acid residues in length”, see Section 2.1 B.mori silk fibroin structure, page 2).
Regarding Claim 6, Vepari further teaches wherein the polypeptide is a structural protein (“provides structural roles”, see page 1, second paragraph after 1.Introduction). Also see Applicant’s paragraph 30 which identifies fibroin as an example of a structural protein.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 1, further in view of Immuno-Biological Laboratories Co., hereon referred to as ‘IBL’ (NPL Reference- Protein Production Business using Transgenic Silkworms).
Regarding Claim 3, Choi is silent to wherein the polypeptide is a recombinant polypeptide. IBL is provided to teach a process of developing a transgenic silkworm technology that enables the production of large amounts of recombinant proteins in silkworm cocoons (see first paragraph). This allows the production of a large amount of a targeted protein, thereby lowering the cost of the synthesized silk proteins (section 1, page 1). Note that IBL is directed to fibroin in particular (Section 2, page 2). Therefore, since Choi is directed to a composition using fibroin material from silkworm cocoons, it would have been obvious to one of ordinary skill in the art to use a recombinant fibroin that is more readily available due to large scale production.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 1, with evidence by Simmons et al. (NPL Reference- Chemoenzymatic modification of silk fibroin with poly(2,6-dimethyl-1,5-phenylene ether) using horseradish peroxidase).
Regarding Claim 5, Choi is silent to wherein the polypeptide contains an (A)n motif. “(A)n motif” is hereon defined as an amino acid sequence mainly containing alanine residues (paragraph 28 of Applicant’s specification). Simmons is directed to silk fibroin also obtained from silk cocoons of Bombyx mori (see page 4 in ‘Materials’ section). Simmons also discloses that the silk fibroin comprises a motif that “consist mainly of glycine and alanine” (see page 2, second paragraph after ‘Introduction’). Therefore, Simmons provides evidence that the silk Fibroin of Choi comprises an (A)n motif.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 1, further in view of Fujii et al. (WO 2019230907 A1- see translations).
Regarding Claim 9, Choi is silent to further comprising a vegetable protein. Fujii is relied on to teach a food composition (see page 29, sixth paragraph) used for improving bone metabolism (page 29, third paragraph). Like Choi, the food composition of Fujii is an osteogenesis promoter which improves bone formation based on the action of promoting osteoblast differentiation (Compare page 29, fifth paragraph of Fujii to Choi’s Abstract). Fujii’s composition further comprises quasi-drug or pharmaceuticals such as proteins (Page 29, seventh paragraph). Proteins can be selected from the list similar to the obesity inhibitor (First embodiment, page 9), which includes soy protein (Page 9, seventh paragraph).
Therefore, since both Fujii and Choi are directed to bone differentiation promoters, it would have been obvious to one of ordinary skill in the art to further comprise vegetable protein such as soy protein for the purpose of imparting a source of protein for nutritional purposes.
Response to Arguments
Applicant’s arguments in the response filed 26 June 2025 has been considered, but is found not persuasive over the prior art.
Applicant argues on the basis that Choi does not use fiber but instead uses fibroin in the form of a cocoa powder that is soluble in water (page 6 of the remarks). However, the argument is not persuasive because Choi’s use of powder is only discussed in the example and Choi does not indicate that the powdered form is required. Furthermore, Choi indicates that the term “silk” means a fiber produced by insect, preferably from Bombyx mori (page 3, third paragraph). Therefore, Choi’s disclosure of incorporating “silk protein” in food compositions (page 4, fourth paragraph) is not seen to limit fibroin to a powdered form. In any case, Vepari was relied on to teach fibroin in the form of fiber. For these reasons, the prior art has been maintained.
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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/T.H.N/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792