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 .
The Applicants’ Amendment to the Claims filed on November 24, 2025 is entered.
The Applicants’ Amendment to the Specification filed on November 24, 2025 is entered.
Claims 2-3 are cancelled.
Claims 1 and 4 are pending and under examination.
Priority
This US 17/781,669 filed on 06/01/2022 is a 371 of PCT/KR2021/000925 filed on 01/22/2021 which claims foreign priority benefit of KOREA, REPUBLIC OF 10-2020-0008336 filed on 01/22/2020. The Filing Receipt of September 30, 2022 is controlling.
Election/Restrictions
Applicant’s election without traverse of the species of SEQ ID NO: 2 in the reply filed on May 27, 2025is as previously acknowledged. Please note that instant SEQ ID NO: 1 fully encompasses instant SEQ ID NO:2 and that claim 2 (reciting SEQ ID NO:2) is presently cancelled.
Response to Amendment
All objections and rejections made in the previous office action and not repeated in this office action are WITHDRAWN in view of the Applicants’ Amendment to the Claims and Specification filed on November 24, 2025. The prior art rejections as anticipated by each of Murphy et al and Alexander et al are overcome based on the amendment which recites consisting of instant SEQ ID NO: 1.
Rejections to presently cancelled claims 2-3 are rendered moot.
Specification - new
The use of the term Tween 80 ([0068]), which is a trade name or mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include proper symbols indicating use in commerce such as TM, SM, , or ® following the terms.
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.
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.
Claims 1 and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This is a new grounds necessitated by amendment.
Claim 1 is presently amended to delete “treating inflammatory disease” in place of “reducing an inflammatory caused in a macrophage”. It is unclear what is intended by the phrase “a method for reducing an inflammatory caused in a macrophage”, to a subject in need thereof. Claim 4, depends from claim 1 and has been amended to recite “the inflammatory disease” to “the inflammatory”. Claim 4 further recites that the inflammatory is caused by atopy, psoriasis, arthritis, dermatitis, allergy, osteoarthritis, rhinitis, otitis media, sore throat, tonsillitis, periodontitis, gingivitis, inflammatory eye disease, cystitis, nephritis, rheumatoid arthritis, spondylitis, inflammatory bowel disease, hepatitis, sepsis, alcoholic liver disease, non-alcoholic fatty liver, epilepsy, or disc degeneration. The scope of claims 1 and 4 is unclear because it appears the intention would be treating an inflammatory disease caused by overexpression of Toll-like receptors (TLRs) in a macrophage. For purpose of examination, claims 1 and 4 are construed to intend treating/reducing LPS-induced inflammation or LPS-induced inflammatory disease in a subject in need thereof wherein the inflammation is caused by overexpression of genes associated with NO, PEG2, pro-inflammatory cytokines, chemokines, or TLR/NF-kB signal transduction in macrophages.
Claim Rejections - 35 USC § 102 – updated for amendment
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nikapitiya et al (Marine drugs 2020 Vol 18, published January 15, 2020; of record). Not that this publication has one inventor in common and may be eligible for a 102(b)(1) exception.
Nikapitiya et al teach administering the antimicrobial peptide octominin to zebra fish. Note that the intended use in the preamble is not generally afforded patentable weight for purpose of applying prior art. Note that the antimicrobial peptide octominin is a 23 amino acid peptide which is identical to instant SEQ ID NO: 1. (See Abstract).
Response to Argument
The Applicants’ response filed on 11/24/2025 to the rejections under 35 USC § 102 have been fully considered but are unpersuasive. (See page 7 of “Remarks”). The applicants argue:
Reconsideration and withdrawal of such §102 rejections is requested.
The invention as now claimed is directed to a new use of the recited peptide, in a method for reducing an inflammatory caused in a macrophage, comprising administering a pharmaceutical composition containing, as an active ingredient, a peptide consisting of the amino acid sequence of SEQ ID NO: 1.
None of Murphy et al., Alexander et al., and Nikapitiya et al. discloses a method of reducing an inflammatory caused in a macrophage.
However, this argument is unpersuasive because the intended use provided in a preamble generally is not afforded patentable weight for purpose of applying prior art.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-9 of copending US Application No. 18/786,152 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are essentially the same as or anticipate the instant claims.
Regarding instant claims 1 and 4, copending claim 6 recites a method for preventing or treating a fish viral disease, the method comprising administering to a fish a peptide having an amino acid sequence of reference SEQ ID NO: 1. Note that reference SEQ ID NO: 1 is identical to instant SEQ ID NO: 1.
Query Match 100.0%; Score 128; Length 23;
Best Local Similarity 100.0%;
Matches 23; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GWLIRGAIHAGKAIHGLIHRRRH 23
Db 1 GWLIRGAIHAGKAIHGLIHRRRH 23
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 10-12 of copending US Application No. 18/298,798 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims.
Regarding instant claims 1 and 4, copending claims 7, and 10-12 recite methods of preventing or treating a disease caused by infection with Acinetobacter baumannii or Candida albicans in an individual comprising treating the individual with an antibacterial peptide consisting of amino acid sequence of reference SEQ ID NO: 1. Note that reference SEQ ID NO: 1 is identical to instant SEQ ID NO: 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Argument
The Applicants’ response filed on 11/24/2025 to the provisional Double patenting rejections have been fully considered but are unpersuasive. (See page 8 of “Remarks”). The applicants argue: that “as now amended, there is a clear subject matter separation of the present claimed invention from the methods specified in the claims of copending Applications 18/786,152 and 18/290,798, and such subject matter separation warrants withdrawal of the nonstatutory double patenting rejection”.
However, this argument is unpersuasive because the intended use provided in a preamble generally is not afforded patentable weight for purpose of applying prior art.
Conclusion
No claim is allowed.
Regarding the NSDP search, the inventor Ilson Hwang is also known as Ilson Whang.
Related art: Sanjeewa et al (Biomolecules 2020 Vol 10, published March 27, 2020).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/ Primary Examiner, Art Unit 1658