DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on March 20, 2026 were received and fully considered. Claim 1 was amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Walton et al. (US PG Pub. No. 2012/0186999 A1) (hereinafter “Walton”) in view of Rigas (US PG Pub. No. 2022/0039690 A1).
Rigas was applied in the previous office action.
With respect to claim 1, Walton teaches a method for detecting Helicobacter pylori using an electrochemical test strip (Abstract; par.51-55; Fig. 1; see also claim 30), wherein the electrochemical test strip comprises:
a strip body, having a detection area for contact with a gas sample (Fig. 1 shows active areas of underlying electrodes remain exposed when in use; see also par.0071);
a working electrode, disposed on the strip body and having a first part located in the detection area (working electrode 3 in Fig. 1; par.0070+);
a reference electrode, disposed on the strip body and having a second part located in the detection area (reference electrode 5 in Fig. 1; par.0070+);
a solid water absorption layer, disposed in the detection area
a battery (par.0041 “reader… to process electrical signals” implies that the reader would need a power source, battery, etc.);
a controller, electrically connected to the working electrode, the reference electrode and the battery (par.0041 “connected to a reader which is configured to process electrical signals from the electrode assembly”);
a casing covering the strip body (par.0072 “suitable covering layer”); and
a blowpipe, disposed on the casing and having a flow channel for the gas sample to flow to the detection area (par.0040 “conduit may comprise a suitable mouthpiece into which the patient may exhale”);
the method for detecting Helicobacter pylori comprises the following steps:
filling the detection area with a second gas sample by making the subject blow on the blowpipe of the electrochemical test strip, and detecting the first gas sample with the electrochemical test strip to obtain a background
feeding the subject with urea (par.0053 “patient swallowing a capsule containing urea”);
filling the detection area with a second gas sample by making the subject blow on the blowpipe of the same or another said electrochemical test strip (par.0053 “post-urea measurements is used to determine the extent of the H. pylori infection”), and detecting the second gas sample with the electrochemical test strip to obtain a desired
comparing the background pH data and the desired pH data to determine whether the subject’s stomach has Helicobacter pylori (par.0053, 0055).
However, Walton does not explicitly disclose utilizing a pH sensing layer in the manner recited.
Rigas teaches a pH sensing layer disposed in a detection area of a breath analyzer device (par.0105+ “increased pH sensitivity is desirable for ammonia detection because when ammonia converts the polyaniline to an emeraldine base, it causes an even larger increase in resistivity and corresponding decrease in conductivity”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Walton to further incorporate a pH sensing layer disposed in the detection area in order to increase pH sensitivity for ammonia detection thereby allowing for easier detection of ammonia, and thus increase the sensitivity of the polyaniline to ammonia, as evidence by Rigas (par.0105+). Furthermore, PHOSITA would have been motivated to combine Walton and Rigas since both teachings relate to the same narrow field of endeavor of determining presence of H. Pylori in exhaled breath.
With respect to claim 2, Rigas teaches wherein the urea is carbon-12 urea (par.0040). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Walton such that the urea is carbon-12 urea in order to detect the presence of H. pylori via another known urea compound, as evidence by Rigas (par.0040).
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been considered, but are moot in view of the combination of references that were necessitated by amendment. Please see prior art section above for more detail, updated citations (new Walton reference), and updated obviousness rationale.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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