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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/24/2025 has been entered.
DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Final office action filed on 6/24/2025 is acknowledged.
3. Claim 1 is pending in this application.
4. Claim 1 is under examination.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 102(a)(1)
5. 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.
6. (Revised due to Applicant’s amendment to the claim) Claim 1 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al (KR 19990047798 A, machine translation used, pages 1-15, cited and enclosed in the previous office actions).
The instant claim 1 is drawn to a method of preventing skin wrinkle in a subject, wherein the method comprises applying to skin of the subject a tetrapeptide consisting of amino acid sequence GQVS (SEQ ID NO: 1), thereby inhibiting elastase and/or increasing collagen production; wherein the tetrapeptide is prepared by a method comprising: obtaining a ginseng fruit extract; fermenting the ginseng fruit extract to obtain a fermented ginseng fruit extract; constructing a peptide library comprising a 2-(4 -nitrophenyl)sulfonylethoxycarbonyl-amino acid; and synthesizing the tetrapeptide of SEQ ID NO: 1 by combining the peptide library with the fermented ginseng fruit extract.
Park et al, throughout the patent, teach a cosmetic composition for skin external application comprising at least one synthetic peptide selected from the group consisting of SY2003, SY2004, SY2005, SY2011 and SY2013; and treatment of skin with such cosmetic composition, including an anti-skin aging method comprising applying such cosmetic composition to the skin of an experimental animal model, for example, Abstract; claims 1 and 2; page 4, Section “Effects of the Invention”; and page 13, testing example 4. Park et al further teach SY2004 consists of the amino acid sequence GQVS (identical to the tetrapeptide of instant SEQ ID NO: 1), for example, page 16-4 of the original KR 19990047798 A. Therefore, in view of the teachings of Park et al as a whole, one of ordinary skilled in the art would immediately envision a method of anti-skin aging in a subject, wherein the method comprises applying to the skin of the subject a cosmetic composition comprising SY2004 (identical to the tetrapeptide of instant SEQ ID NO: 1). In the instant case, the instant claimed method is a method of preventing skin wrinkle in a subject. Since the method immediately envisioned from the teachings of Park et al as a whole above is one applying the same peptide to the skin of a subject, the method immediately envisioned from the teachings of Park et al as a whole above inherently results in preventing skin wrinkle in the subject.
Furthermore, with regards to the limitation “thereby inhibiting elastase and/or increasing collagen production”, this is a result-oriented limitation. In the instant case, the method immediately envisioned from the teachings of Park et al as a whole above comprises the same active method step, i.e., the same subject, the same compound and the same route of administration, therefore, administering the same compound to the same subject via the same route of administration would lead to the same effect, i.e., inhibiting elastase and/or increasing collagen production. Therefore, the method immediately envisioned from the teachings of Park et al as a whole above inhibits elastase and/or increases collagen production. And, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
In addition, with regards to the limitation “wherein the tetrapeptide is prepared by a method comprising: obtaining a ginseng fruit extract; fermenting the ginseng fruit extract to obtain a fermented ginseng fruit extract; constructing a peptide library comprising a 2-(4-nitrophenyl)sulfonylethoxycarbonyl-amino acid; and synthesizing the tetrapeptide of SEQ ID NO: 1 by combining the peptide library with the fermented ginseng fruit extract”, this is a product by process limitation for obtaining the tetrapeptide of instant SEQ ID NO: 1. The MPEP states the following: "[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..." (see MPEP § 2113 I). And in the instant case, the peptide SY2004 in Park et al is identical to the tetrapeptide of instant SEQ ID NO: 1.
And, the MPEP states the following: A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (see MPEP § 2131.02).
Since the reference teaches all the limitations of instant claim 1; the reference anticipates instant claim 1.
Response to Applicant's Arguments
7. Applicant maintains the arguments that Park et al do not disclose that the method therein prevents skin wrinkling or that it achieves the inhibition of elastase and/or an increase in collagen production. Applicant further argues that the tetrapeptide recited in instant claim 1 may be structurally distinct from the tetrapeptide SY2004 in Park et al.
8. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments that Park et al do not disclose that the method therein prevents skin wrinkling or that it achieves the inhibition of elastase and/or an increase in collagen production:
First, as stated in both the previous office action and Section 6 above, the Examiner would like to point out that the instant claimed method is a method of preventing skin wrinkle in a subject. Therefore, in the instant case, since the method immediately envisioned from the teachings of Park et al as a whole is one applying the same peptide to the skin of a subject, the method immediately envisioned from the teachings of Park et al as a whole inherently results in preventing skin wrinkle in the subject.
Second, with regards to the limitation “thereby inhibiting elastase and/or increasing collagen production”, as stated in Section 6 above, this is a result-oriented limitation. In the instant case, the method immediately envisioned from the teachings of Park et al as a whole comprises the same active method step, i.e., the same subject, the same compound and the same route of administration, therefore, administering the same compound to the same subject via the same route of administration would lead to the same effect, i.e., inhibiting elastase and/or increasing collagen production. Therefore, the method immediately envisioned from the teachings of Park et al as a whole inhibits elastase and/or increases collagen production. Since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise. And, in the instant case, Applicant fails to provide any data and/or evidence to prove otherwise.
In response to Applicant’s arguments that the tetrapeptide recited in instant claim 1 may be structurally distinct from the tetrapeptide SY2004 in Park et al:
First, the Examiner understands that Park et al do not teach the tetrapeptide SY2004 is prepared by the method recited in instant claim 1. However, in the instant case, as stated in Section 6 above, with regards to the limitation “wherein the tetrapeptide is prepared by a method comprising: obtaining a ginseng fruit extract; fermenting the ginseng fruit extract to obtain a fermented ginseng fruit extract; constructing a peptide library comprising a 2-(4-nitrophenyl)sulfonylethoxycarbonyl-amino acid; and synthesizing the tetrapeptide of SEQ ID NO: 1 by combining the peptide library with the fermented ginseng fruit extract”, this is a product by process limitation for obtaining the tetrapeptide of instant SEQ ID NO: 1. The MPEP states the following: "[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..." (see MPEP § 2113 I). And in the instant case, the peptide SY2004 in Park et al is identical to the tetrapeptide of instant SEQ ID NO: 1. Other than statements/arguments, Applicant fails to provide any data and/or evidence to indicate the peptide SY2004 in Park et al is not identical to the tetrapeptide of instant SEQ ID NO: 1.
Second, with regards to the references cited by Applicant, the Examiner would like to point out that both references cited by Applicant are related to incorporate non-natural amino acids into a peptide, wherein such non-natural amino acids alter the structure of the peptide. The fact pattern in these references is different from instant claimed tetrapeptide. As stated in both Section 6 and the paragraph above, the peptide SY2004 in Park et al is identical to the tetrapeptide of instant SEQ ID NO: 1, and both consist of the same amino acid sequence GQVS. Therefore, it is unclear to the Examiner why and/or how the same tetrapeptide consisting of the same amino acid sequence GQVS can have different structures and/or different properties/functionalities. Further clarification is required.
Taken all these together, the rejection is deemed proper and is hereby maintained.
New Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Written Description
9. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
10. Applicant is required to cancel the new matter in the reply to this Office Action.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
The MPEP states that “The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (“If n-propylamine had been used in making the compound instead of n-butylamine, the compound of claim 13 would have resulted. Appellants submit to us, as they did to the board, an imaginary specific example patterned on specific example 6 by which the above butyl compound is made so that we can see what a simple change would have resulted in a specific supporting disclosure being present in the present specification. The trouble is that there is no such disclosure, easy though it is to imagine it.”) (emphasis in original). In Ex parte Ohshiro, 14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989), the Board affirmed the rejection under 35 U.S.C. 112, first paragraph, of claims to an internal combustion engine which recited “at least one of said piston and said cylinder (head) having a recessed channel.” The Board held that the application which disclosed a cylinder head with a recessed channel and a piston without a recessed channel did not specifically disclose the “species” of a channeled piston.” (see MPEP § 2163).
In the instant case, claim 1 recites the limitation “wherein the tetrapeptide is prepared by a method comprising: obtaining a ginseng fruit extract; fermenting the ginseng fruit extract to obtain a fermented ginseng fruit extract; constructing a peptide library comprising a 2-(4-nitrophenyl)sulfonylethoxycarbonyl-amino acid; and synthesizing the tetrapeptide of SEQ ID NO: 1 by combining the peptide library with the fermented ginseng fruit extract”.
With regards to the recited “wherein the tetrapeptide is prepared by a method comprising: obtaining a ginseng fruit extract; fermenting the ginseng fruit extract to obtain a fermented ginseng fruit extract; constructing a peptide library comprising a 2-(4 -nitrophenyl)sulfonylethoxycarbonyl-amino acid; and synthesizing the tetrapeptide of SEQ ID NO: 1 by combining the peptide library with the fermented ginseng fruit extract”, the recitation has never been explicitly disclosed and/or discussed in the instant specification. The detailed explanations are as followings:
Lack of Ipsis Verbis Support
The specification is void of any literal support for the limitation “wherein the tetrapeptide is prepared by a method comprising: obtaining a ginseng fruit extract; fermenting the ginseng fruit extract to obtain a fermented ginseng fruit extract; constructing a peptide library comprising a 2-(4-nitrophenyl)sulfonylethoxycarbonyl-amino acid; and synthesizing the tetrapeptide of SEQ ID NO: 1 by combining the peptide library with the fermented ginseng fruit extract” recited in instant claim 1. Therefore, the instant specification fails to provide literal support to such limitation recited in instant claim 1.
Lack of Implicit or Inherent Support
“While there is not in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” See MPEP § 2163. Thus support can be furnished implicitly or inherently for a specifically claimed limitation. In the instant case, the instant specification discloses the peptide is synthesized by utilizing 2-(4-nitrophenyl)sulfonylethoxycarbonyl-amino acid (Nsc-amino acid) as an intermediate, for example, page 6, paragraph [0019]; and page 14, paragraph [0055] of instant specification. The instant specification also discloses how to obtain the peptide from the fermented ginseng fruit extract on pages 13-15 of instant specification. However, the instant specification fails to provide any suggestion for “synthesizing the tetrapeptide of SEQ ID NO: 1 by combining the peptide library with the fermented ginseng fruit extract”. Therefore, it is determined that the instant specification fails to provide any implicit or inherent support to the limitation “synthesizing the tetrapeptide of SEQ ID NO: 1 by combining the peptide library with the fermented ginseng fruit extract” recited in instant claim 1.
Taken all these together, the instant specification fails to provide support to the limitation “wherein the tetrapeptide is prepared by a method comprising: obtaining a ginseng fruit extract; fermenting the ginseng fruit extract to obtain a fermented ginseng fruit extract; constructing a peptide library comprising a 2-(4-nitrophenyl)sulfonylethoxycarbonyl-amino acid; and synthesizing the tetrapeptide of SEQ ID NO: 1 by combining the peptide library with the fermented ginseng fruit extract” recited in instant claim 1.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658