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 .
Amendment after Non-final office action filed on March 23, 2026 is acknowledged.
Claims 1-12 and 15-20 have been cancelled.
New claims 21-23 have been added.
Claims 13-14 and 21-23 are pending in this application.
Applicant elected with traverse of Group 1 (claims 1-11, 13-14 and 17-20) and elected without traverse of phosphorylation as the species of modification, micelle as the species of nanostructure, SEQ ID NO: 15 as the species of an antimicrobial peptide or peptide derivative, solvent which may be sterilized isotonic aqueous solution as the species of pharmaceutically acceptable carrier, basal polymer as species of additional agent, and sterilized isotonic aqueous solution as the species of solvent in the reply filed on November 12, 2025. The traversal was not found persuasive, and the restriction was deemed to be proper and made FINAL in the previous office action. Claims 22-23 are withdrawn from consideration, pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. A search was conducted on the elected species, SEQ ID NO: 15, and prior art was found. Claim 21 is withdrawn from further consideration as being drawn to nonelected species. Claims 13-14 are examined on the merits in this office action.
This application contains new claims 22-23 drawn to inventions nonelected in the response filed on 11/12/2025. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Withdrawn Objection and Rejections
Objection to the abstract is hereby withdrawn in view of Applicant’s amendment to the abstract.
Rejections of claims 1-11, 13-14 and 17-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are hereby withdrawn in view of Applicant’s amendment to the claims.
Rejections of claims 2-4, 9 and 17-18 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, are hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claims 1-8, 10-11, 13-14 and 17-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (Written Description), is hereby withdrawn in view of Applicant’s amendment to the claims.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained and Revised Rejection
35 U.S.C. 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) 13-14 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Srivastava et al (Journal of Biomolecular Structure and Dynamics, 2020, 1-20, cited in the previous office action). This rejection is maintained and revised in view of Applicant’s amendment to the claims.
Srivastava et al teach the peptide of instant SEQ ID NO: 15 (RAMPNMLRIMASLVLARKH) (see p. 10, S.No. 39), meeting the limitation of instant claim 13. Srivastava et al teach Ag-patches comprising CTL epitope cluster (see table 2), meeting the limitation of instant claims 13-14. With respect to the limitation in the preamble of claim 13, “Composition having antimicrobial activity..”, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the preamble does not affect the active components. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation. Additionally, in regards to the recitation “an antimicrobial peptide having an amino acid sequence…”, since Srivastava et al teach the same peptide sequence as instant SEQ ID NO: 15 in a vaccine composition, the peptide of Srivastava et al would inherently have the same function and activity as instant SEQ ID NO: 15. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).”
Since the reference teaches ALL of the active components of instant claims, the reference anticipates instant claims 13-14.
Response to Applicant’s Arguments
Applicant argues that “Applicant has amended claim 13 to define a composition having antimicrobial activity and comprising an antimicrobial peptide defined by a list of specific amino acid sequences…Srivastava et al neither disclose nor suggest any antimicrobial activity, antimicrobial peptides, compositions for antimicrobial use, or any technical teaching related to the inhibition of bacteria.” Applicant further argues that “…the present claims are directed to compositions having antimicrobial activity. The presently claimed antimicrobial compositions act directly on bacterial cell walls/membranes to kill or inhibit bacteria, rather than functioning as epitopes to stimulate the body’s immune system.”
Applicant’s arguments have been fully considered but are not found persuasive. Instant claims are drawn to product invention, i.e., a composition comprising peptide(s). Therefore, since Srivastava et al teach a composition comprising the same peptide sequence as instant SEQ ID NO: 15, the Srivastava reference would have the same antimicrobial activity as instant composition comprising the same peptide. The MPEP 2112.01 II states that “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical structure, the properties applicant discloses and/or claims are necessarily present. Id”. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., claimed antimicrobial compositions act directly on bacterial cell walls/membranes to kill or inhibit bacteria) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The rejection is deemed to be proper and is maintained herein.
Improper Markush
(Revised in view of Applicant’s amendment to the claims)
Claim 13 is rejected on the judicially created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F. 2d 716, 721-22 (CCPA 1980) and Ex parte Hazumi, 3 USPQ 2d 1059, 1060 (BPAI 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The compounds claimed do not share a common structural feature and a common use. For example, SEQ ID NO: 1 has the sequence HAVGNIMHIASAVLVRH; SEQ ID NO: 2 has the sequence HKAVGQIMHIASAVLVRH; SEQ ID NO: 3 has the sequence HRAMPNMLKIMASLVLAKR; SEQ ID NO: 10 has the sequence HKRAMPSIVKMIATLVLARKH; SEQ ID NO: 15 has the sequence RAMPNMLRIMASLVLARKH; SEQ ID NO: 30 has the sequence KAMPNIVRIMASLVLARHK. The sequences have different amino acid contents.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR 41.31 (a)(1) (emphasis provided).
Response to Applicant’s Arguments
Applicant argues that “These 15 amino acid sequences share substantial structural features and a common utility, fully satisfying the requirements for a proper Markush grouping. Specifically, all 15 sequences are linear peptides without cyclization. Each sequence contains cationic residues (R/K/H) with positively charged sites distributed at ten N-terminal, middle, and C-terminus.” Applicant argues that “…the hydrophobic residue ratio for all 15 sequences falls within 35% to 45%, enabling all sequences to form amphipathic helices, a core functional structure of antimicrobial peptides, thereby demonstrating significant structural homology.”
Applicant’s arguments have been fully considered but art not found persuasive. As indicated in the rejection above, the peptide sequence do not share a common core sequence. It is unclear to the Examiner the point of Applicant’s arguments in regards to the number of hydrophobic residues/hydrophobic ratio/ and “within 35%-45%”. The peptide sequences recited in the claims do not share a common core sequence, therefore, the claim recites an improper Markush grouping. The rejection is deemed to be proper and is maintained herein.
New Objection
Claim 13 is objected to for the following: Claim 13 is missing the article “A” in the preamble of the claim. Applicant is required to correct this error.
CONCLUSION
No claim is allowed.
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 JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO 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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/JULIE HA/Primary Examiner, Art Unit 1654
4/23/2026
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