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
Applicant’s election without traverse of Group I and the detection of antibodies to HP0547/CagA, HP 1125/PalA, HP0596/Tipa, HP1177/Omp27, HP0103/TlpB, HP0709, HP0900/HypB, HP0371/FabE, HP0243/NapA, HP0153/RecA, and HP0385 in the reply filed on 9-10-2025 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 Claims 4-6 and 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Information Disclosure Statement
The Information Disclosure Statement filed on 4-15-2025 has been considered. An initialed copy is attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 1-3 and 7-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 17/761,653 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to methods of detecting antibodies to H. pylori antigens generally and HP0371/FabE and HP0243/NapA specifically. It should be noted that while the overlap in antibodies being detected is not complete, the detection of antibodies to known H. pylori antigens is deemed an obvious variation of the recited methods.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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.
Claims 1 is 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”. Said terms constitute laboratory designations and convey no particular structure (i.e. sequence). As written, it is impossible to determine the metes and bounds of the claimed invention.
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.
Claims 1-3 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Labaer et al. (WO 2021/062041 – IDS filed on 4-15-2025).
Labaer et al. disclose methods of detecting IgG and IgA antibodies to H. pylori proteins in a biological sample (see abstract and paragraph [0002]). Labaer et al. further disclose that said proteins can be HP0547/CagA (see paragraph [0005], HP 1125/PalA (see Table 2), HP0596/Tipa (see Table 2), HP1177/Omp27 (see Table 4), HP0371/FabE (see paragraph [00005], Table 2 and Table 5), HP0243/NapA (see paragraph [0005] and Table 2), HP0153/RecA (see Table 2), and HP0385 (see Table 2); that said antibodies are detected using a rapid ELISA which utilize immobilized antigens and labeled secondary antibodies (see paragraph [0040]); that said proteins are immobilized on a solid support (see claim 20 for example); and that the biological sample is blood (see paragraph [0038]. Consequently, Labaer et al. anticipates all the limitations of the rejected claims.
Claim Rejections - 35 USC § 103
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 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.
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.
Claims 1-3 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Labaer et al. (WO 2021/062041 – IDS filed on 4-15-2025).
Labaer et al. disclose methods of detecting IgG and IgA antibodies to H. pylori proteins in a biological sample (see abstract and paragraph [0002]). Labaer et al. further disclose that said proteins can be HP0547/CagA (see paragraph [0005], HP 1125/PalA (see Table 2), HP0596/Tipa (see Table 2), HP1177/Omp27 (see Table 4), HP0371/FabE (see paragraph [00005], Table 2 and Table 5), HP0243/NapA (see paragraph [0005] and Table 2), HP0153/RecA (see Table 2), and HP0385 (see Table 2); that said antibodies are detected using a rapid ELISA which utilize immobilized antigens and labeled secondary antibodies (see paragraph [0040]); that said proteins are immobilized on a solid support (see claim 20 for example); and that the biological sample is blood (see paragraph [0038]..
Labaer et al. differs from the rejected claims in that they don’t disclose screening their biological samples for antibodies to HP01038/TlpB, HP0709 or HP0900/HypB. The KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Labaer et al. disclose the screening of biological samples for antibodies to a multitude of H. pylori proteins and the various H. pylori antigens/proteins (including HP01038/TlpB, HP0709 or HP0900/HypB) are well established in the art, the screening for antibodies against HP01038/TlpB, HP0709 or HP0900/HypB utilizing the methods of Labaer et al. is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 January 15, 2026