The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 5-5-2026 is acknowledged. Claims 1-20 are pending. Claims 4-6 and 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-3 and 7-10 are currently under examination.
Claim Rejections Withdrawn
The provisional rejection of claims 1-3 and 7-10 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 17/761,653 (reference application) is withdrawn in light of the amendment thereto.
The rejection of claims 1-3 and 7-10 under 35 U.S.C. 102(a)(1) as being anticipated by Labaer et al. (WO 2021/062041 – IDS filed on 4-15-2025) is withdrawn in light of the amendment thereto.
The rejection of claims 1-3 and 7-10 under 35 U.S.C. 103 as being unpatentable over Labaer et al. (WO 2021/062041 – IDS filed on 4-15-2025) is withdrawn in light of the amendment thereto.
Claim Rejections Maintained
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.
Claims 1-3 and 7-10 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.
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite rendered vague and indefinite by the use of the terms “HP0547/CagA”, “HP 1125/PalA”, “HP0596/Tipa”, “HP1177/Omp27”, “HP0103/TlpB”, “HP0709”, “HP0900/HypB”, “HP0371/FabE”, “HP0243/NapA”, “HP0153/RecA”, and “HP0385” is maintained for reasons of record.
Applicant argues:
1. Each HP#### locus tag corresponds to a defined gene and a known amino-acid sequence.
2. Claims 1-3 are amended to recite the GenBank accession numbers for each of the claimed antigens.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Point 1, it is well established in the art that various proteins vary from strain to stain of H. pylori. Consequently, a given HP#### designation conveys no particular structure.
With regard to Point 2, the recitation of GenBank Accession numbers does not convey a specific structure as the sequences associated with a given accession number can change over time.
As outlined previously, said terms constitute laboratory designations and convey no particular structure (i.e. sequence). Moreover, the recitation of GenBank Accession numbers does not convey a specific structure as the sequences associated with a given accession number can change over time. As written, it is impossible to determine the metes and bounds of the claimed invention.
New Grounds of Rejection
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.
Claims 1-3 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (Journal of Gastroenterology, Vol. 58, pages 11-124 – IDS filed on 4-15-2025).
Song et al. disclose methods of detecting IgG and IgA antibodies to H. pylori proteins in a biological sample (see abstract and page 114). Song et al. further disclose that said proteins can be HP0709, HP0103/TlpB, HP0900/HypB, HP0547/CagA, HP 1125/PalA, HP0596/Tipα, HP1177/Omp27, HP0371/FabE, HP0243/NapA, HP0153/RecA, and HP0385 (see Table 2); that said antibodies are detected using ELISA which utilize immobilized antigens on a solid support and labeled secondary antibodies (see page 115); and that the biological sample is serum (see page 114). Consequently, Song et al. anticipates all the limitations of the rejected claims.
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.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 July 9, 2026
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