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 04/29/2026 in which claims 1, 4-6 were amended, and claims 2-3 was canceled, has been entered. Claims 7-16 were previously withdrawn.
Claims 1, 4-6 are under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 04/29/2026 after the Nonfinal Office Action mailed on 12/29/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 04/29/2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 12/29/2025.
Claim Objections
(Previous objections, withdrawn as to claims 2-6). Applicant’s amendments to the instant claims have overcome previous objections to claims 2-6.
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(Previous rejection, withdrawn as to claims 1-6) Claims 1-6 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to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 as submitted on 04/29/2026.
The previous rejections of claims 2-3, are moot in view of Applicant’s cancelation of these claims.
Applicant’s amendment to the instant claims has overcome the previous rejections to claims 1, 4-6.
(New rejection, necessitated by amendment as to claims 1, 4-6) Claims 1, 4-6 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.
Amended claim 1 recites “collecting the washing liquid containing an adherent mucosal fluid discharged to an entrance of the nose”. This recitation is unclear because it appears to be grammatically incorrect. For instance, it is not clear if the indicated recitation is meant to be understood as “collecting the washing liquid containing an adherent mucosal fluid previously sprayed to an entrance of the nose” or “collecting the washing liquid containing an adherent mucosal fluid which was sprayed to an entrance of the nose” or a different meaning. Further, it is not clear if the term “discharged” refers to a previous step comprising spraying or not. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claim 1 was herein interpreted as referring to collecting the washing liquid containing an adherent mucosal fluid previously sprayed to an entrance of the nose.
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.
(Previous rejections, withdrawn as to claims 2-3, maintained and modified as necessitated by amendment as to claims 1, 4-6) Claims 1, 4-6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Levitz et al. (prior art of record).
See claims 1, 4-6 as submitted on 04/29/2026.
The previous rejections of claims 2-3 are moot in view of Applicant’s cancelation of these claims.
Regarding amended claim 1, it is noted that the limitations previously recited by canceled claims 2, 3, have been incorporated into claim 1. However, these limitations are already taught by Levitz et al., as previously noted. Specifically, Levitz teach a nasal-spray sampling method for detecting an infectious pathogen comprising the following steps:
applying a washing liquid to the nasal cavity of a subject suspected of an infectious disease to wash the mucosal surface of the nasal cavity (Abstract, ¶¶ [0009]-[0015])
collecting the nasal washings containing the mucosal washings of the nasal cavity (Abstract, ¶¶ [0009]-[0015])
collecting the specimen comprising nasal washings after administering 500 microliters of nasal from the nasal cavity (¶¶ [0886], [0874]) which lies between the claimed range
applying the washing liquid into the nostril by spraying (¶ [0066])
detecting the infectious pathogen, for example an influenza virus, in the sample (¶ [0096])
Regarding claim 4-6, as previously noted, Levitz et al. further teach detection of an influenza virus infection (¶ [0096]), wherein testing the specimen sample for the presence of the virus includes performing an immunological assay, for example a lateral flow assay and/or a gene amplification assay, for example a molecular test that utilizes polymerase chain reaction (PCR) (¶ [0090]).
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive.
Applicant contends on pages 8 and 9 of the Remarks submitted on 04/29/2026:
“Levitz does not teach or suggest a step of spraying 300 µl to 500 µl of a washing liquid to the nasal cavity of a subject suspected of an infectious disease to wash the mucosal surface of the nasal cavity… Levitz also does not teach or suggest washing liquid containing an adherent mucosal fluid discharged to an entrance of the nose."
In response:
The instant rejection is in view of instant claim language. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The disclosure of Levitz et al. teaches and suggests the exact limitations as indicated above, including a step of spraying, the precise volume of 500 µl of a washing liquid (Levitz et al. ¶¶ [0066], [0886]) and collecting the specimen comprising nasal washings from the nasal cavity (¶ [0874], [0886]). In this regard, Levitz states at ¶ [0886]: “Following nasal saline spraying and swabbing, swabs were found to contain between approximately 76-131 microliters of fluid from a single nostril (Table 2), after administering about 500 microliters of nasal wash into the nostril. Utilizing relatively smaller swab tips for respiratory specimen collection may be beneficial because of the limited volumes of lysing buffer included in commercial immunoassay kits (Table 3), which must be sufficient for the extraction of viral antigens from virions, intact infected cells, or infected cell debris which have been collected by the swab.” (emphasis added).
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 extension fee 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 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-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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