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 .
Receipt is acknowledged for amendment and remarks filed 02/25/2026.
Claims 1, 4-6 and 9 are amended.
Claims 10-14 are canceled.
New claims 16-25 are added.
Claims 1-6, 9, 15-25 are pending.
Priority
This application is a 371 of PCT/KR2022/008353 filed 06/14/2022 and which claims benefit of KOREA application 10-2021-0077563 filed 06/15/2021.
Response to Arguments
On page 6 of 10 and the first full three paragraphs of the remarks, applicant argues that the amendment to claim 1 and the fact that claims 4-6 were not included in the rejection under 35 USC 102, the rejection under 35 USC 102 is overcome; that the cited art does not teach using a single enzyme system and that there is no guidance or direction that would a person of ordinary skill in the art to modify the prior art to arrive at the claimed invention; that there is no teaching or guidance in the applied art that would have let the ordinary skilled artisan to select the specific combination of features set forth in the claimed invention with reasonable expectation of success and that absent impermissible hindsight, the cited reference would not have led a skilled artisan to the claimed invention, citing In re Dow Chem. Co., 837 F.2d 469, 473 (Fed. Cir. 1988), Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 381 F.3d 1371 (Fed. Cir. 2004).
Response: The examiner disagrees with respect to claim 9 because claim 9 is a product by process claim. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Claim 9 is a cosmetic composition comprising low-molecular weight silk sericin. The composition is prepared by the method of claim 1, which is the method of making the sericin composition by the method of claim 1. Claims 4-6 were rejected and with regards to alcalase or esperase, KWON SOO HAN teaches alcalase enzyme, which is a subtilisin as described in the last office action. The rejection did not rely on impermissible hindsight but the rejection was based on what is known in the art. The decisions in In re Dow Chem. Co., 837 F.2d 469, 473 (Fed. Cir. 1988), Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 381 F.3d 1371 (Fed. Cir. 2004) support the rejections made in the office action of 11/25/2025.
On page 7 of 10, starting from the 4th full paragraph, applicant argues that the instant specification shows advantages of using single enzyme system, rather than a mixture of enzymes referring to Example 1, FIGS. 3A and 3B which show that single enzyme had slightly higher activity than two-enzyme mixtures because as stated by the specification, this showing “may be due to substrate competition between the two enzymes, resulting in reduced activity compared to the single enzyme and that overall, the enzymes with optimal activity were alcalase and esperase, which showed the highest activity in the pH range of 7 to 9.” Applicant’s argument continues to page 9 of 10 pointing to Example 2, FIGS, 4A and 4B, Example 3, FIGS. 5A and 5B, Example 4, FIGS 6A and 6B, Example 5, Table 2, Example 6, Table 3, all showing single enzyme system of alcalase and esperase show slightly higher activity that two enzyme mixtures. The argument is that the prior art does not suggest the improved results using single enzyme system.
Response: The claims presented for examination and examined for the office action mailed 11/25/2025 do not recite alcalase and esperase. Further, applicant appears to be arguing for teachings in applicant’s specification and not what is claimed. While claims are interpreted in light of the specification, limitations from the specification cannot be transported into the claims. Applicant’s arguments appear to be intending to import limitations from the specifications into the claims (MPEP § 2111.01). The prior art teaches alcalase which is the same enzyme applicant is describing and hence single enzyme.
Regarding applicant’s statement that the claimed invention must be considered as a whole, the examiner notes that the claimed invention was considered as whole as limited by the claims. The prior art is considered for all that the prior art teaches (W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983)).
Specification
Objection to the Specification
The use of the terms alcalase and esperase, which are trade names or a marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
New Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 5, and 16-17 contain the trademark/trade names ALCALASE and ESPERASE in line 2 of claim 4, and in line 1 of claims 16 and 17. Claim 5 is included in the rejection because claim 5 is dependent on claim 4 and includes the Trademark names. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe serine endopeptidase that are primarily subtilisin A and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 9 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over KWON SOO HAN et al. (KR20170105955A Eng Trans).
Claim 9 is a composition comprising low molecular weight silk sericin having molecular weight of less than 1 kDa and the composition is produced by the process in claim 1. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
“[E]ven 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case the prior art teaches the claimed composition.
KWON SOO HAN et al. (KR20170105955A) teaches cosmetic composition comprising low molecular weight silk sericin of 1 kDa or less (see the whole document with emphasis on paragraphs [0001], [0004], [0005], [0008]-[0013], [0015], [0026], [0039], [0049]-[0051], [0053]).
Claim Rejections - 35 USC § 103
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.
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) 9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over KWON SOO HAN et al. (KR20170105955A) as applied to claim 9 as evidenced by TANIHARA JP 2004066177 A, Eng Trans PE2E) and JP 5603857 B2 (Eng Trans PE2E), in combination with DIAZ GOMEZ et al (US 20180344605 A1)
Claim 9 has been described above as being anticipated by KWON SOO HAN as evidenced by JP 5603857 B2 and TANIHARA.
Claim 15 depends on claim 9.
The composition of KWON SOO HAN is a cosmetic composition. The composition of KWON SOO HAN does not contain any of the essential oils claimed in claim 15. However, cosmetic compositions containing sericin and essential oils such as jasmine, ylang-ylang, bergamot, lemon, orange, sandalwood, rosewood, thyme and myrrh are known in the art and accords fragrance to the cosmetic compositions (see paragraphs [0001], [0013], [0035], [0226]).
Therefore, before the effective date of the invention the artisan would include essential oil fragrance to the composition of KWON SOO HAN that would predictably produce fragranced cosmetic composition.
Therefore, KWON SOO HAN as evidenced by JP 5603857 B2 and TANIHARA in combination with DIAZ GOMEZ renders claim 15 prima facie obvious.
Allowable Subject Matter
The closest prior art, KWON SOO HAN et al. (KR20170105955A) discloses method of producing low-molecular weight sericin of 1 kDa or less (paragraph [0039], Fig. 3)) by refining silk yarn to extract sericin and mixing the sericin with an enzyme composition --- KWON SOO HAN extracts sericin from golden silkworm (paragraphs [0009]), the sericin is refined at temperatures of 80 to 120 oC for 1 to 3 hours, the extracted sericin is mixed with enzyme and hydrolyzed at 60 oC for 36 hours (paragraph [0012]) and one of the method of separating sericin is by soap refining and alkaline salt refining (paragraph [0022]. 80 to 120 oC for the refining process overlaps the claimed range of 90 to 150 oC, and 1 to 3 hours overlaps the claimed time range of 10 to 120 minutes (2 hrs) and the disclosed time range allows for 60 (1 hr) to 120 minutes (2 hrs) and the disclosed time of 1-3 hrs allow for 60 (1 hr) to 120 minutes (2 hr) .
KWON SOO HAN does not use the term “scouring.” However, scouring silk includes removal of serin from the silk or cocoon and the use of proteolytic enzyme that cleaves the sericin (see Item 7 of JP 5603857 B2 using the translation for PE2E) and is also removing sericin wrapping silk fibroin fiber with alkaline aqueous solution (see paragraph [0016] of TANIHARA JP 2004066177 A). Therefore, the process used in KWON SOO HAN is also scouring.
However, KWON SOO HAN uses combination of enzymes to effect the production of low molecular weight sericin of less than 1 kDa. KWON SOO HAN adds alcalase enzyme, flavorzyme enzyme and protamex enzyme to the sericin solution for hydrolyzing the sericin (paragraphs [0012], [0029]). Instant claim 1 uses one enzyme system.
Therefore, claims 1-3, 6, and 18-25 are allowable over the closest art.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613