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 .
Election/Restrictions
Applicant elected, without traverse, Group I (Claims 1-15), drawn to a peptide, for examination. In addition, Applicant elected the following species for examination: Elected Peptide Species: (ii) SGSWLRDVWDWICTVLTDFKTWLQSKL (SEQ ID NO: 2), as recited in Claim 5. Elected Viral Infection Species: Dengue, as recited in Claim 20. The claim readable on the elected species is Claims 1 and 5-15.
Claims 1-15 are hereby examined on the merits. Claims 16, 17, 19, 20 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16th June 2026.
Priority
This application filed 10/13/2023 is a National Stage entry of PCT/SG2022/050213 , International Filing Date: 04/13/2022, claims foreign priority to 10202103747S, filed 04/13/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/30/2023 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
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.
(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.
Claim(s) 1-15 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Nam-Joon Cho et al., hereinafter Cho (Nam-Joon Cho et al., WO2016209173A1; EFD 2016-06-24; reference provided in the IDS).
The applied reference has a common Applicant and Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Cho teaches SEQ ID NO: 2 in the instant application. As noted below, Qy is SEQ ID NO: 2 and Db is SEQ ID NO: 10 in Cho, which presents 100 % sequence identity.
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Regarding the claim limitation ‘wherein:….L- or D-amino acid’, Cho teaches that the anti-infective peptides may comprise D amino acids, L amino acids or a combination thereof (see Abstract). Cho teaches the following structure: NH2-PEG12-Amide-PEG12-peptide, wherein the peptide is amidated at the C-terminus (see [0094] last two lines (i.e. (C)).
Regarding claim 2, as noted in the rejection for claim 1, Cho teaches anti-infective peptides comprising D amino acids, L amino acids or a combination thereof (see Abstract).
Regarding claims 3, 4 and 5, the rejection in claims 1 and 2 have been noted above.
Regarding claim 6, Cho teaches that anti-infective peptides may comprise L amino acids (see Abstract).
Regarding claim 7, Cho teaches that anti-infective peptides may comprise D amino acids (see Abstract).
Regarding claim 8, Cho teaches that anti-infective peptides may comprise D amino acids, L amino acids or a combination thereof (see Abstract).
Regarding claim 9, Cho teaches the following structure: NH2-PEG12-Amide-PEG12-peptide, wherein the peptide is amidated at the C-terminus (see [0094] last two lines) (i.e. (AI)).
Regarding claim 10, Cho teaches the following structure: NH2-PEG12-Amide-PEG12-peptide (see [0094] last two lines. Cho teaches that the hydrophilic polymer may be linked to the peptide at the C-terminus, N-terminus or at both the C-terminus and N-terminus (see [0097], last few lines) (i.e. (aa)). Cho teaches that pegylated peptides comprises one, two or more PEG polymers in the molecular weight range of 500 to 5000 daltons (i.e. (ab)). In certain embodiments, the PEG polymers are branched. In other embodiments, the PEG polymers are non-branched (see [0028]) (i.e. (ac)).
Regarding claim 11, Cho teaches a composition comprising an effective amount of anti-infective peptide and a pharmaceutically acceptable carrier or vehicle, wherein a pharmaceutically acceptable carrier or vehicle can comprise an excipient, diluent, or a mixture thereof (see [5.4] COMPOSITIONS [00125], last few lines).
Regarding claim 12, Cho teaches excipients (see [5.4] COMPOSITIONS [00125], last few lines).
Regarding claim 13, Cho teaches, intravenous, intraperitoneal, subcutaneous, topical, oral, nasal, and other administration routes ([0011] last three lines).
Regarding claim 14, Cho teaches vial containing a lyophilized composition (see [0031] first two lines).
Regarding claim 15, Cho teaches that anti-infective peptides may be formulated for administration in human or veterinary medicine (see [00126] last two lines).
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 16, 28, 29 of U.S. Patent No. US8728793B2 in view of Nam-Joon Cho et al., hereinafter Cho (Nam-Joon Cho et al., WO2016209173A1; EFD 2016-06-24; reference provided in the IDS).
The teachings in Cho have been set forth above.
Regarding claim 1, reference patent ‘793 teaches AH peptide. Embodiments of the specification disclose AH peptide of SEQ ID NO: 32 (see Col 12, line 51) that is 100 % identical to SEQ ID NO: 2 in the instant application. See claims 1, 16, 28 and 29. Reference patent teaches that AH peptides comprise D-amino acids (Col 16, line 9).
Reference patent ‘793 does not teach (B), (C) or (D).
Cho teaches that the peptide is amidated at the C-terminus (see [0094] last two lines (i.e. (C)).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of the reference patent ‘793 to generate an amidated C-terminus of the peptide. One motivated to do so, would have a reasonable expectation of success, as both references teach anti-infective peptide, with 100 % sequence identity to the instantly claimed sequence. Thus, one would have recognized that applying the teaching of the reference patent ‘793 with the teaching in Cho would have yielded predictable results and improved the composition, as Cho specifically teaches that pegylation of an anti-infective peptide increases the half-life of the peptide in vivo [0098]. See MPEP §2143.
Regarding claim 2, in addition to the obviousness rationale noted above, reference patent ‘793 teaches that AH peptides comprise D-amino acids (Col 16, line 9).
Regarding claims 3, 4 and 5, the rejection in claims 1 and 2 have been noted above.
Regarding claim 6, reference patent ‘793 does not specifically teach L-amino acids.
Cho teaches that anti-infective peptides may comprise L amino acids (see Abstract).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of the reference patent ‘793 to L-amino acids. Thus, one would have recognized that applying the teaching of the reference patent ‘793 with the teaching in Cho would have yielded predictable results and improved the composition, as Cho specifically teaches that especially the L-isomer of the anti-infective peptide, displays good cytotoxicity in tested cells [00291]. See MPEP §2143.
Regarding claim 7, reference patent ‘793 teaches that AH peptides comprise D-amino acids (Col 16, line 9).
Regarding claim 8, , reference patent ‘793 teaches that AH peptides comprise D-amino acids (Col 16, line 9). Cho teaches that anti-infective peptides may comprise D amino acids, L amino acids or a combination thereof (see Abstract).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the composition of the reference patent ‘793, to include D and L amino acids as specifically suggested in Cho. Thus, one would have recognized that applying the teaching of the reference patent ‘793 with the teaching in Cho would have yielded predictable results and improved the composition, as Cho specifically teaches L-isomer and D-isomer anti-infective peptides (see Abstract). See MPEP §2143.
Regarding claim 9, reference patent ‘793 does not teach amino or carboxy functional groups at N- and C- termini. Cho teaches the following structure: NH2-PEG12-Amide-PEG12-peptide, wherein the peptide is amidated at the C-terminus (see [0094] last two lines) (i.e. (AI)).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the composition of the reference patent ‘793, to include amino functional group at both termini as suggested in Cho. Thus, one would have recognized that applying the teaching of the reference patent ‘793 with the teaching in Cho would have yielded predictable results as pegylation of an anti-infective peptide increases the half-life of the peptide in vivo [0098]. See MPEP §2143.
Regarding claim 10, the obviousness rationale has been set forth above. Reference patent discloses AH peptide PEGylation to increase serum half-life (Col 17, 4th paragraph, line 14).
Reference patent does not teach PEGylation at the N or C terminus, or branched/unbranched PEG polymers or PEG polymers in the range of 500-5000 Da.
Cho teaches the following structure: NH2-PEG12-Amide-PEG12-peptide (see [0094] last two lines. Cho teaches that the hydrophilic polymer may be linked to the peptide at the C-terminus, N-terminus or at both the C-terminus and N-terminus (see [0097], last few lines) (i.e. (aa)). Cho teaches that pegylated peptides comprises one, two or more PEG polymers in the molecular weight range of 500 to 5000 daltons (i.e. (ab)). In certain embodiments, the PEG polymers are branched. In other embodiments, the PEG polymers are non-branched (see [0028]) (i.e. (ac)).
Regarding claim 11, reference patent ‘793 teaches AH peptide. Embodiments of the specification disclose excipient (Col 24, line 3), carrier (Col 26, line 61).
Regarding claim 12, reference patent ‘793 teaches excipients in the claimed AH peptide (Col 24, line 3).
Regarding claim 13, Cho teaches, intravenous, intraperitoneal, subcutaneous, topical, oral, nasal, and other administration routes ([0011] last three lines).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to administer the composition of the reference patent ‘793, using administration routes as suggested in Cho. Thus, one would have recognized that applying the teaching of the reference patent ‘793 with the teaching in Cho would have yielded predictable results as Cho specifically teaches administration of the peptide [0011]. See MPEP §2143.
Regarding claim 14, Cho teaches vial containing a lyophilized composition (see [0031] first two lines).
Regarding claim 15, Cho teaches that anti-infective peptides may be formulated for administration in human or veterinary medicine (see [00126] last two lines).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the composition of the reference patent ‘793, and formulate for use in medicine as suggested in Cho. Thus, one would have recognized that applying the teaching of the reference patent ‘793 with the teaching in Cho would have yielded a use in medicine (see [00126] last two lines). See MPEP §2143.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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