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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
BRI of “an amino acid sequence of SEQ ID NO: 1” includes full-length SEQ ID NO: 1 and fragments thereof because of the indefinite article “an”.
BRI of the transitional phrase “having” is open in view of paragraphs [0021]-[0025] of the specification (MPEP § 2111.03(IV)).
Therefore, the active agent in the instant claims may consist or comprise full-length SEQ ID NO: 1 or any fragment thereof.
If Applicant wishes to limit the scope of the active agent to a peptide consisting of or comprising full-length SEQ ID NO: 1, the claim should be amended to “the amino acid sequence of SEQ ID NO: 1”.
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.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chung et al. (U.S. Patent No. 10,344,061, published 9 July 2019; hereafter “Chung”).
Chung teaches a pharmaceutical composition for preventing and/or treating hypomelanosis, the pharmaceutical composition containing, as an active ingredient, a peptide consisting of the amino acid sequence of SEQ ID NO: 2 (col 4, lns 42-47). SEQ ID NO: 2 taught by Chung is identical to instant SEQ ID NO: 1.
Regarding the claimed use of treating or preventing inflammatory lung disease in claim 1 and the further functional effects in dependent claims 2-8, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art peptide is structurally identical to the instantly claimed peptide. The peptide is an active ingredient in the prior art composition, suitable for pharmaceutical use. Therefore, the prior art composition and peptide must be capable of performing the instantly claimed functions.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jin Sook Suh et al. (NPL 2, IDS 7/16/2025; hereafter “Suh”).
Suh teaches a pharmaceutical composition effective in an inflammatory lung disease model comprising the peptide hBD3-3 as an active agent (p. 5427, col 2). The peptide hBD3-3 comprises the amino acid sequence RR (Figure 1), which is a fragment of instant SEQ ID NO: 1. Therefore, claim 1 is anticipated by Suh.
Regarding the functional effects in dependent claims 2-8, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art peptide is structurally identical to the instantly claimed peptide, which includes peptide comprising fragments of instant SEQ ID NO: 1. The peptide is an active ingredient in the prior art composition, suitable for pharmaceutical use and is shown to be effective in a model for inflammatory lung disease. Therefore, the prior art composition and peptide must be capable of performing the instantly claimed functions.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chung et al. (WO 2022/015069, published 20 January 2022; English language equivalent is US2024/0051993 A1; hereafter “Chung”).
Chung teaches a peptide KYLLVHRPYYRR (SEQ ID NO: 3) ([0035]), which is identical to instant SEQ ID NO: 1. Chung teaches a pharmaceutical composition for preventing or treating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, comprising the peptide ([0045]).
Regarding the claimed use of treating or preventing inflammatory lung disease in claim 1 and the further functional effects in dependent claims 2-8, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art peptide is structurally identical to the instantly claimed peptide. The peptide is an active ingredient in the prior art composition, suitable for pharmaceutical use. Therefore, the prior art composition and peptide must be capable of performing the instantly claimed functions.
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.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. (U.S. Patent No. 10,344,061, published 9 July 2019; hereafter “Chung”) in view of Um et al. (CN 107206047 A, hereafter “Um”).
Determining the scope and contents of the prior art.
Chung teaches a composition for preventing and/or treating hair loss and promoting hair growth, the composition containing, as an active ingredient, a peptide consisting of the amino acid sequence of SEQ ID NO: 2 (col 4, lns 1-47). SEQ ID NO: 2 taught by Chung is identical to instant SEQ ID NO: 1.
Ascertaining the differences between the prior art and the claims at issue.
Chung does not teach a functional food comprising the peptide consisting of instant SEQ ID NO: 1 as an active ingredient.
Resolving the level of ordinary skill in the pertinent art.
Um teaches a functional food for preventing and/or treating hair loss and promoting hair growth, the composition containing, as an active ingredient, a peptide (p. 5).
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The specification does not present any evidence that a functional food comprising instant SEQ ID NO: 1 has unexpected properties.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the peptide of instant SEQ ID NO: 1 taught by Chung for the active agent peptide in the functional food taught by Um. It would have been obvious to substitute one active peptide agent for another because both are taught in the prior art to be suitable for the same use, promoting hair growth and preventing hair loss. The rationale for obviousness is simple substitution of one known element for another to obtain predictable results (MPEP § 2143.01(B)). The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art.
Although the resulting functional food would be intended for preventing and/or treating hair loss and promoting hair growth, it would possess the ability of treating lung inflammation and pulmonary fibrosis because the active agent, the peptide of SEQ ID NO: 1, is identical to the claimed active agent.
Therefore, claims 9-10 are obvious over the cited art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 8:30 am - 5 pm.
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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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CHRISTINA M MARCHETTI BRADLEY
Primary Examiner
Art Unit 1654
/CHRISTINA M MARCHETTI BRADLEY/Primary Examiner, Art Unit 1654
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