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 .
Acknowledgement of Receipt
Applicant’s Response, filed 8/5/2026, in reply to the Office Action mailed 5/6/2026, is acknowledged and has been entered. Claims 1, 13, 14, 17 and 20 have been amended. Claims 1-7, 9-11, 13-14, 17, 20 and 22-27 are pending, of which claims 3-7, 13-14, 17, 20 and 23-27 are withdrawn as being directed to non-elected species or invention. Regarding claims 13 and 14 it is noted that Applicant elected, in the Response filed 2/2/2026, the generic fluorescent moiety as species. Claims 1, 2, 9-11 and 22 are examined herein on the merits as being directed to an elected invention.
Response to Arguments
Applicant’s arguments have been fully considered. Any rejection not reiterated herein has been withdrawn as being overcome by claim amendment. New grounds of rejection are set forth, in view of claim amendment. The Examiner’s response to Applicant’s arguments is incorporated below
Claim Rejections - 35 USC § 102
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)(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.
The following reference was found during search for the elected species as part of a batch search, it should not be interpreted that a comprehensive search was performed for all non-elected species. The reference is provided in the interest of compact prosecution.
Claim(s) 1, 9-11 and 22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ruiz et al. (US 2021/0364491).
Ruiz discloses a biorecognition element for rapid detection of microbial biocontamination, the biorecognition element comprising: SEQ. ID No. 2 through SEQ. ID No. 24, SEQ. ID No. 26 through SEQ. ID No. 44, SEQ. ID No. 46 through SEQ. ID No. 57, SEQ. ID No. 59 through SEQ. ID No. 196 or SEQ. ID No. 198 through SEQ. ID No. 332; and further comprising: a C-terminal, three-glycine plus cysteine linker configured to cross-link to an amine-functionalized quantum dot (claims 1-3). See also claims 4-5 further comprising: an amine-functionalized quantum dot cross-linked to the cysteine linker; and a reporter molecule conjugated to the amine-functionalized quantum dot; and wherein the reporter molecule is a fluorescent molecule, a chemiluminescent molecule, a colorimetric molecule, or a signal transducing nanomaterial.
SEQ. ID No. 27 corresponds to AITSRNA, see Table 2 and page 16, which is consistent with SEQ. ID No. 26 of the instant claims.
Regarding claim 22, a 0.1 mL of 1.5 μM Peptide BRE-QD solution in PBS at room temperature for 15 to 30 min may be used to label microbes (paragraph 0038).
With regard to the limitation wherein the peptide is a nerve-targeting peptide conjugate, is it is noted that the recitation of the intended use of the conjugate does not distinguish over Ruiz because 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. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 9-11 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bremel et al. (WO 2011/119484).
Bremel teaches identification of the sequences of peptides which have a high probability of being B-cell and/or MHC binding sites comprising T-cell epitopes on the surface of a variety of microorganisms or cells, or MHC binding sites comprising T cell epitopes internal to microorganisms or cells (page 4).
See SEQ ID NO 3207537, https://seqdata.uspto.gov/seqdetail?docId=US20130330335A1&publicationNo=20130330335&seqId=3207537.
Instantly claimed sequence SEQ ID NO:1 has 100 % identity (100 % similarity) over 7 positions in a common overlap (range (q:s): 1-7:12-18) with subject GS_PROT_ALERT:WO2011119484.3207537 (Irtacrarslsalplsass; length: 19).
The polypeptides and antibodies of the invention may be used in a number of assay formats, including, but not limited to, radio-immunoassays, ELISAs (enzyme linked immunosorbant assay), "sandwich" immunoassays, immunoradiometric assays, immunofluorescence assays, and immunoelectrophoresis assays.
In some embodiments, the polypeptides and antibodies are conjugated to a hapten or signal generating molecule. Suitable haptens include, but are not limited to, biotin, 2,4-Dintropheyl, Fluorescein derivatives (FITC, TAMRA, Texas Red, etc.) and Digoxygenin. Suitable signal generating molecules include, but are not limited to, fluorescent molecules, etc. (page 91-92).
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a peptide as taught by Bremel which is conjugated to a fluorescent molecule. One would have been motivated to do so, with a reasonable expectation of success, because Bremel teaches that the polypeptides can be conjugated to a fluorescent molecule for use in diagnostic assays, such as immunofluorescent assays.
With regard to the limitation of the amended claims wherein a nerve targeting peptide conjugate consists essentially of a peptide of a length from 7 residues to 15 residues, it is noted that see MPEP 2111.03 with regard to consisting essentially of langugage, For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 ("PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention."). See also AK Steel Corp. v. Sollac, 344 F.3d 1234, 1240-41, 68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003).
Dependent claim 11 recites a peptide linker, accordingly additional amino acids are encompassed by the instant claims. Further, linking at C terminus is taught by Bremel (paragraph 0350).
Regarding claim 22, pharmaceutical compositions are taught, see pages 82 and 91.
With regard to the limitation wherein the peptide is a nerve-targeting peptide conjugate, is it is noted that the recitation of the intended use of the conjugate does not distinguish over Ruiz because 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. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
Conclusion
No claims are allowed at this time.
The following references are made of record as being relevant to the invention: US 2018/0153975; US 2021/0104294 and US 2018/0141998.
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 LEAH H SCHLIENTZ whose telephone number is (571)272-9928. The examiner can normally be reached Monday-Friday, 8:30am - 12:30pm EST.
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/LHS/
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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