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 .
Election/Restrictions
Applicant's election with traverse of Group I claims 1-5 and 12-17 in the reply filed on 07/17/2026 is acknowledged.
The traversal is on the ground(s) that Applicants submits a verified English translation of Japanese Priority Application No. 2022-009397 filed January 25, 2022 and that Applicant has confirmed that the presently pending claims have written description support in the Japanese priority document and that as a result, the claims of the present application are entitled to an effective filing date of at least January 25, 2022.
Applicants state that in contrast, the Matsui reference relied upon in the Restriction Requirement was published on October 10, 2022, which is later than the effective filing date of the present application. Therefore, Matsui should not constitute prior art against the present claims and should not support the determination that the claimed inventions are independent or distinct.
Applicants argument has been carefully considered but is not found persuasive because the groups of inventions listed in the restriction requirement still do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of a reagent for detecting an antibody that binds to a H. suis whole cell, in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell and an anti-Ig antibody, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Flahou et al. Vaccine 27 (2009) 1416-1421.
Flahou et al disclose a reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from the subject, the reagent comprising at least the H. suis whole cell i.e. H. suis whole bacterial cell proteins and a goat anti-mouse IgG.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-11 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/17/2026.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed and a translation of the certified copy was submitted 07/17/2026.
Information Disclosure Statement
The information disclosure statements filed 07/25/2024, 09/27/2024, 04/09/2025 and 12/10/2025 have been considered and initialed copies are enclosed.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See page 3 paragraph 8.
Claim Objections
Claim 5 and 15-17 are objected to because of the following informalities: Please include the full meaning of ELISA in the first occurrence in the claims. Appropriate correction is required.
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.
Claim(s) 1-3, 5, 12 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flahou et al. Vaccine 27 (2009) 1416-1421.
Claim 1: Flahou et al disclose a reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from the subject, the reagent comprising at least the H. suis whole cell i.e. H. suis whole bacterial cell proteins and goat anti-mouse IgG.
Claim 2: “for detecting an antibody that binds to a H. suis whole cell, in a specimen derived from a subject wherein the subject is a mammal” is drawn to the intended use of the reagent.
A recitation of 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.
Flahou et al discloses the reagent as set forth above comprising the H. suis whole cell i.e. H. suis whole bacterial cell proteins and goat anti-mouse IgG and is capable of performing the intended use and the reagent of Flahou meets the claim.
Claim 3: Claim 3 is drawn to the intended use. Flahou et al discloses the reagent as set forth above comprising the H. suis whole cell i.e. H. suis whole bacterial cell proteins and goat anti-mouse IgG and is capable of performing the intended use and the reagent of Flahou meets the claim.
Claim 5: The reagent according to claim 1 wherein the reagent is a reagent for ELISA or immunochromatography is an intended use limitation. Flahou et al discloses the reagent as set forth above comprising the H. suis whole cell i.e. H. suis whole bacterial cell proteins and goat anti-mouse IgG and is capable of performing the intended use and the reagent of Flahou meets the claim.
Claim 12: The reagent, according to claim 2, wherein the specimen is derived from blood is drawn to an intended use. Flahou et al discloses the reagent as set forth above comprising the H. suis whole cell i.e. H. suis whole bacterial cell proteins and goat anti-mouse IgG and is capable of performing the intended use and the reagent of Flahou meets the claim.
Claim 15: The reagent according to claim 2, wherein the reagent is a reagent for ELISA or immunochromatography is drawn to an intended use. Flahou et al discloses the reagent as set forth above comprising the H. suis whole cell i.e. H. suis whole bacterial cell proteins and goat anti-mouse IgG and is capable of performing the intended use and the reagent of Flahou meets the claim.
Claim 16: The reagent according to claim 3, wherein the reagent is a reagent for ELISA or immunochromatography is drawn to an intended use. Flahou et al discloses the reagent as set forth above comprising the H. suis whole cell i.e. H. suis whole bacterial cell proteins and goat anti-mouse IgG and is capable of performing the intended use and the reagent of Flahou meets the claim.
Claim(s) 1-3, 5, 12 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Emiko et al. Isolation and characterization of Helicobacter suis from human stomach. Proc Natl Acad Sci U S A. 2021 Mar 30;118(13) cited in IDS.
Claim 1: Emiko et al disclose a reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and donkey anti-mouse IgG. See supplementary material page 3 under “ELISA for measuring H. suis-specific IgG in mice serum”.
Claim 2: “for detecting an antibody that binds to a H. suis whole cell, in a specimen derived from a subject wherein the subject is a mammal” is drawn to the intended use of the reagent.
A recitation of 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.
Emiko et al disclose a reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and donkey anti-mouse IgG and thus is capable of performing the intended use and the reagent of Emiko meets the claim.
Claim 3: Claim 3 is drawn to the intended use. Emiko et al discloses the reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and donkey anti-mouse IgG and thus is capable of performing the intended use and the reagent of Emiko meets the claim.
Claim 5: The reagent according to claim 1 wherein the reagent is a reagent for ELISA or immunochromatography is an intended use limitation. Emiko et al discloses the reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and donkey anti-mouse IgG and thus is capable of performing the intended use and the reagent of Emiko meets the claim.
Claim 12: The reagent, according to claim 2, wherein the specimen is derived from blood is drawn to an intended use. Emiko et al discloses the reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and donkey anti-mouse IgG and thus is capable of performing the intended use and the reagent of Emiko meets the claim.
Claim 15: The reagent according to claim 2, wherein the reagent is a reagent for ELISA or immunochromatography is drawn to an intended use. Emiko et al discloses the reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and donkey anti-mouse IgG and thus is capable of performing the intended use and the reagent of Emiko meets the claim.
Claim 16: The reagent according to claim 3, wherein the reagent is a reagent for ELISA or immunochromatography is drawn to an intended use. Emiko et al discloses the reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and donkey anti-mouse IgG and thus is capable of performing the intended use and the reagent of Emiko meets the claim.
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.
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.
Claim(s) 1, 2, 3, 4, 13-14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naito et al. Clinical Journal of Gastroenterology (2021) 14: 478-483 in view of Emiko et al. Isolation and characterization of Helicobacter suis from human stomach. Proc Natl Acad Sci U S A. 2021 Mar 30;118(13) cited in IDS an Kikei et al.
JP2006284567A cited in IDS.
Naito et al disclose a subject diagnosed as having a Helicobacter pylori and Helicobacter suis superinfection. See title and under introduction.
Naito et al disclose serum H. pylori IgG antibodies were positive in said subject. See page 479 column 1.
Naito et al disclose H. suis was also detected in said subject by PCR. See p. 479 column 1.
Naito also discloses that diagnosis of non-H. pylori helicobacters (NHPH p. 478 column 1 first paragraph) may involve methods used to diagnose H. pylori infections including urinary antibody tests (see p. 482 column 1 first sentence).
Naito et al does not disclose a reagent comprising at least a H. suis whole cell and an anti-Ig antibody and that the reagent further comprises a H. pylori cell component or an antibody against the H. pylori cell component.
Claim 1: Emiko et al disclose a reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and an donkey anti-mouse IgG. See supplementary material page 3 under “ELISA for measuring H. suis-specific IgG in mice serum”.
Claim 2: “for detecting an antibody that binds to a H. suis whole cell, in a specimen derived from a subject wherein the subject is a mammal” is drawn to the intended use of the reagent.
A recitation of 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.
Emiko et al disclose a reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and a donkey anti-mouse IgG and thus is capable of performing the intended use and the reagent of Emiko meets the claim.
Claim 3: Claim 3 is drawn to the intended use. Emiko et al discloses the reagent for detection of an antibody that binds to H. suis whole cell in a specimen derived from a subject, the reagent comprising at least the H. suis whole cell lysate and donkey anti-mouse IgG and thus is capable of performing the intended use and the reagent of Emiko meets the claim.
Kikei disclose a reagent comprising an H. pylori cell component wherein the H. pylori cell component is H. pylori specific antigen and a secondary antibody against the H. pylori specific antigen. Kikei disclose the H. pylori specific antigen (H. pylori cell component) can be whole cells of H. pylori, urease and/or flagellar protein, vacuolated toxin (VacA) and toxin-associated protein (CagA).
Reference is made to the whole of Kikei (translated) including the portions cited below.
Kikei teaches in the abstract: “The presence of the infection by the pylori bacterium and whether the pylori bacterium is the toxic stock or not are diagnosed by measuring a human antibody to a helicobacter pylori specific antigen contained in saliva or urine.”
Kikei teaches: “In the Helicobacter pylori infection diagnostic kit, the Helicobacter pylori specific antigen comprises (1) urease and / or flagellar protein, (2) vacuolated toxin (VacA), toxin-associated protein (CagA) and neutrophil activity. Any one selected from activated protein (NapA)”.
Kikei teaches: Preferred examples of the antigen for detecting H. pylori include whole cells of H. pylori, urease, catalase, flagellar protein, etc.
Kikei teaches : “In addition, as the secondary antibody against the labeled Helicobacter pylori specific antigen or the labeled human antibody, those labeled with colored latex or gold colloid are preferably used from the viewpoint of stability and operability”
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of Naito et al drawn to detecting both H. pylori and H. suis in a subject by combining reagents i.e. the H. suis whole cell and anti-IgG antibody for detecting antibody to H. suis as taught by Emiko et al and reagents for detecting H. pylori i.e. H. pylori cell component and antibody against the H. pylori cell component as taught by Kikei, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Naito et al is drawn to diagnosing H. pylori and H. suis infection in a subject having both infections and disclose detecting serum IgG to H. pylori and thus the H. pylori cell component and antibody against the H. pylori cell component disclosed by Kikei can be used to detect the serum IgG and since Naito et al disclose that urinary antibody test can be used to detect NHPH infections such as H. suis, the H. suis antibody in the subject can be detected with the reagent of Emiko comprising at least the H. suis whole cell and an anti-IgG antibody.
Thus, the combination of Naito, Emiko and Kikei results in reagents for detection H. pylori and H. suis antibodies in the subject of Naito, wherein the reagents comprise at least the H. suis whole cell and an anti-IgG antibody and H. pylori cell component and antibody against the H. pylori cell component.
Regarding claims 4, 13 and 14: the recitation of “for detecting also an antibody that binds to H. pylori or an antigen of an H. pylori cell component, in the specimen derived from the subject is drawn to the intended use of the reagent.
The reagents of the combination of Naito, Emiko and Kikei for detecting H. suis and H. pylori antibodies are capable of performing the intended use and so said reagent meets the claims.
Regarding claim 17: the recitation of wherein the reagent is a reagent for ELISA or immunochromatography is an intended use of the reagent.
The reagents of the combination of Naito, Emiko and Kikei for detecting H. suis and H. pylori antibodies are capable of performing the intended use and so said reagent meets the claims.
Status of Claims
Claims 1-5 and 12-17 are rejected. Claims 6-11 and 18-20 are withdrawn.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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