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 .
Response to Amendment
The Amendment filed 11/18/2025 in which claims 1, 3, 10, 15, 17, 25 were amended, new claims 41-46 were added, and claims 5, 26, 28-29, 31-33 were canceled, has been entered. Claims 24, 25, 34, 36, 37 were previously withdrawn.
Claims 1-3, 10, 15, 17, 38, 39, 41-46 are under examination on the merits.
Drawings
(Previous objection, withdrawn) Applicant’s amendments to the Drawings submitted on 11/18/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 08/18/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 11/18/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 08/18/2025.
Nucleotide and/or Amino Acid Sequence Disclosures
(Previous objection, withdrawn) Applicant’s amendments to the Specification concerning nucleotide and/or amino acid sequence disclosures submitted on 11/18/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 08/18/2025.
Claim Objections
(Previous objections, maintained as to claim 2, withdrawn as to claims 5, 10 and 15). Applicant’s amendments to claims 10, 15 have overcome previous objections to those claims. The previous objections to claim 5 is moot in view of Applicant’s cancelation of that claim.
Claim 2 remains objected to because the claim language lacks consistency in relation to claim 1, which claim 2 depends on. As previously explained, the recitation of “from each strain or subtype of influenza”, should read “from the first and the second influenza strains or subtypes”.
(New objection, necessitated by the amendment to claim 17 and the addition of claim 45) Claims 17, 45 are objected to because of the following informalities:
On claim 17 the recitation of “SEQ ID NO: 598-995” should read “SEQ ID NOs: 598-995”.
Claim 45 is objected to for reciting two periods at the end of the sentence. See MPEP 608.01 (m).
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(Previous rejection, withdrawn as to claims 3 and 17) Claims 3 and 17 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.
See claims 3 and 17 as submitted on 11/18/2025.
Applicant’s amendments to claims 3 and 17 have overcome previous objections to those claims.
(New rejection, necessitated by amendment as to claims 1-3, 10, 15, 17, 38, 39, 41-46) Claims 1-3, 10, 15, 17, 38, 39, 41-46 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.
See claims 1-3, 10, 15, 17, 38, 39, 41-46 as submitted on 11/18/2025.
Amended claim 1 recites “wherein said plurality of probes comprises a peptide probe from said first and said second influenza strain or subtype, wherein said peptide probe comprises at least 10 amino acids and at most 60 amino acids”. It is unclear which (first of second) “peptide probe” comprises at least 10 amino acids and at most 60 amino acids, or alternatively if Applicant intended to mean both, first and second, peptide probes comprise at least 10 amino acids and at most 60 amino acids. Therefore, the claim is indefinite. The dependent claims do not provide additional clarity. Therefore, they are also indefinite. For purposes of compact prosecution and applying prior art, claim 1 was interpreted herein as referring to either the first of second, or both peptide probes comprising at least 10 amino acids and at most 60 amino acids.
Claim 10 is rejected as indefinite because it depends on a canceled claim, claim 5. For purposes of compact prosecution and applying prior art, claim 10 was interpreted herein as dependent on claim 1.
Claim 17 recites “wherein said array is a human array and said plurality of probes is selected from SEQ ID NOs: 1-1390 or said array is a non-human array and said plurality of probes is selected from SEQ ID NO: 598-995.” This recitation is unclear because the indicated human and non-human SEQ ID NOs overlap while the claim differentiates between human and non-human probes. Further, it is noted that it is not clear if all of the SEQ ID NOs (1-1390) comprise peptides from Applicant’s elected species H1N1 and H3N2 because the neither the Specification nor the sequence listing as filed on 08/08/2022 indicate the parental strain or subtype of each peptide. For the purposes of compact prosecution and applying prior art, claim 17 was interpreted herein consistent with Applicant’s elected species as referring to H1N1 and H3N2 peptides for a human array, or H7N9 and H5N1 peptides for a non-human array.
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.
(Previous rejection, withdrawn as to claims 1-3, 5, 10, 17, 38, 39) Claims 1-3, 5, 10, 17, 38, 39 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khan et al. (prior art of record).
See claims 1-3, 5, 10, 17, 38, 39 as submitted on 11/18/2025.
The previous rejection of claim 5 is moot in view of Applicant’s cancelation of that claim.
Applicant’s amendments have overcome previous rejections to claims 1-3, 10, 17, 38, 39.
(New rejection, necessitated by amendment as to claims 1-3, 17, 38, 39, 41-46) Claims 1-3, 17, 38, 39, 41-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Price et al. “Characterization of influenza vaccine immunogenicity using influenza antigen microarrays.” PLoS One. 2013;8(5):e64555. Published 05/19/2013. Cited in Applicant’s IDS submitted on 04/20/2023.
See claims 1-3, 17, 38, 39, 41-46 as submitted on 11/18/2025.
Regarding claim 1, Price et al. disclose an influenza protein and peptide microarray to allow detection of specific antibody against diverse influenza virus strains targeted to linear and conformational HA epitopes (Abstract). Price et al. further disclose such influenza protein and peptide microarray comprises peptide probes immobilized on specific locations on the microarray, wherein the peptide probes are from a first and a second influenza strain or subtype (for example, H1N1 (A/Brisbane/59/2007), H3N2 (A/Brisbane/10/2007) and the peptide probes are 19 amino acid residues long (Fig. 1; pages 1, 4). Price et al. further disclose the influenza protein and peptide microarray further comprises a recombinant protein from a first and from a second influenza strain or subtype (Figs. 1, 3; pages 1, 4).
Regarding claim 2, Price et al. further disclose the influenza protein and peptide microarray of claim 1, wherein a plurality of probes comprises at least two probes from each strain or subtype of influenza (Figs 1, 2, pages 1, 4).
Regarding claim 3, as explained above, Price et al. further disclose the influenza microarray of claim 1, wherein a first influenza strain or subtype is H1N1 influenza and a second influenza strain or subtype is H3N2 (Fig. 1; pages 1, 4).
Regarding claim 17, as explained above, Price et al. disclose the influenza microarray of claim 1, wherein the array is a human array and a first influenza strain or subtype is H1N1 influenza and a second influenza strain or subtype is H3N2 (Fig. 1; pages 1, 4).
Regarding claim 38, Price et al. further disclose the influenza microarray of claim 1 as a platform or kit comprising labeled secondary antibodies for detection (page 2).
Regarding claim 39, Price et al. disclose the influenza microarray of claim 1 as a system comprising labeled secondary antibodies for detection and a detector or imager to visualize and quantify antibody binding (pages 2-4).
Regarding claims 41-43 and 46, Price et al. disclose the influenza microarray of claim 1 comprising probes from for example, H1N1 influenza and H3N2 influenza strains from 2008 and 2009 (page 4), wherein the probes (peptide and recombinant protein) are from the HA protein which is a surface protein (Abstract).
Regarding claims 44 and 45, as explained above, Price et al. disclose peptide probes that are 19 amino acid residues long (Fig. 1; pages 1, 4).
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.
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.
(Previous rejection, withdrawn as to claim 15). Claim 15 was rejected under 35 U.S.C. 103 as being unpatentable over Khan et al., in view of Meegan et al. (prior art of record).
See claim 15 as submitted on 11/18/2025.
Applicant’s amendments have overcome the previous rejection to claim 15.
(New rejection, necessitated by amendment as to claim 10) Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Price et al., as applied to claims 1-3, 17, 38, 39, 41-46 above, in view of Khan et al. (prior art of record).
See claim 10 as submitted on 11/18/2025.
Regarding claim 10, as explained above, Price et al. teach the influenza microarray of claim 1. Price et al. do not teach wherein the plurality of probes comprises a peptide probe from a neuraminidase (NA) protein from a first and a second influence strain or subtype.
However, Khan et al. teach an influenza antigen microarray constructed by printing purified hemagglutinin (HA) and neuraminidase (NA) antigens, both of which are surface proteins, onto a nitrocellulose-coated membrane using a microarray printer such that the multiple protein probes are immobilized at discrete locations on the microarray for the benefit of identifying antigen-specific antibody responses (pages 1, 3, 8; Figs. 1, 2, 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated teachings of Khan et al. about incorporating neuraminidase peptides into the microarray taught by Price et al. for the benefit of characterizing host responses and identifying antigen-specific antibody responses as taught by Khan et al.
One of ordinary skill in the art would have had reasonable expectation of success in incorporating neuraminidase peptides into the microarray taught by Price et al. given that the methods of detecting antibody responses against influenza surface proteins using an array are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
(New rejection, necessitated by amendment as to claim 15) Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Price et al., as applied to claims 1-3, 17, 38, 39, 41-46 above, in view of Meegan et al. (prior art of record).
See claim 15 as submitted on 11/18/2025.
Regarding claim 15, as explained above, Price et al. teach the influenza microarray of claim 1. Price et al. do not teach wherein microarray probes further comprise a lysate from a cell infected by each of said influenza strains or subtypes.
However, Meegan et al. teach an array for detection of antibodies from multiple pathogens including influenza virus (Abstract, ¶¶ [0005], [0026]). Meegan et al. further teach the use of lysates from cells infected with pathogens such as different strains of influenza virus as targets for binding in the array to characterize host responses and identify a host’s antibody response “fingerprint” (¶¶ [0023]-[0027]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated teachings of Meehan et al. about incorporating lysates from cells infected cells as target into the microarray taught by Price et al. for the benefit of characterizing host responses and identifying a host’s antibody response “fingerprint” as taught by Meegan et al.
One of ordinary skill in the art would have had reasonable expectation of success in incorporating lysates from cells infected cells as target into the microarray taught by Price et al. given that the methods of detecting antibody responses against influenza virus in an array are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
Applicant contends on page 13 of the Remarks submitted on 01/18/2025:
“Khan does not teach short peptide probes. Khan states "For this study, purified influenza antigens containing His10 tags were obtained from commercial vendor (see Table of Materials) and collaborators. These antigens include 251 total HA antigens, with 63 globular head domains (HA1) and 186 full-length proteins (HAO), including 96 monomeric HAO proteins and 90 trimerized HAO proteins containing fused trimerization ("foldon") domain.”
In response:
In view of the amendments submitted on 11/18/2025, a new rejection is submitted in the present Office Action. As such, Applicant’s arguments, while fully considered, are moot in view of the current grounds of rejection set forth above.
Applicant contends on page 14 of the Remarks submitted on 01/18/2025:
“Claim 15 was found novel as it recited viral lysates. Meegan is brought as teaching viral lysates. However, Meegan does not teach short viral peptides of 10-60 amino acids. Table 1 of Meegan provides the only influenza probes used and these are all either full viruses or recombinant proteins. No peptides of shorter than 60 amino acids are listed. Indeed, the shortest protein listed is over 300 amino acids long. As such, a combination of Khan and Meegan does not render instant claim 1 obvious.”
In response:
Applicant's arguments against the references individually are not persuasive because one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As explained above and previously, Meegan et al. were cited for teaching viral lysates not short peptides; and Price et al. were cited for teaching short peptides. Thus, in view of the instant claim language, it is herein submitted that one of ordinary skill in the art would have been motivated and had a reasonable expectation of success in arriving at the claimed invention in view of Price et al. in view of Meegan et al. It is further noted that the prior art already teaches generating short peptides by overlapping, for example 10 amino acids along the span of a desired target antigen (See for example, Price et al. [page 4]). Accordingly, short peptides comprising overlapping sequences generated with a known antigen (such as an NA protein) as a template are considered to be obvious in view of the teachings of Price et al.
Conclusion
No claims are 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 MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672