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 without traverse of Group I, claims 1-6 drawn to a method for detecting, in the reply filed on 12/08/2025 is acknowledged.
Claims 7-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 1-6 are under examination on the merits.
Priority
Applicant’s claim for foreign priority of prior-filed Japanese application No. 2020-122106 filed on 07/16/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 01/12/2023, 12/05/2023, 01/30/2024, 03/04/2024, 03/26/2024, 07/15/2024, 08/22/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
It is noted that no Drawings were filed with instant application.
Specification
The use of the term “Tween 20” on page 8, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that “Tween 20” is merely an example and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
Claim Objections
Claims 2-6 are objected to because of the following informalities:
On claims 2-6, the recitation of “Claim,” bears a typographical error, where “Claim” should read “claim”. Appropriate correction is required.
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 1-6 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.
Claim 1 recites “using, as a sample, the collected washing liquid.” Such recitation fails to indicate any active, positive steps describing how the using is actually practiced. Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, claim 1 is indefinite. 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 a step of collecting a sample comprising washing liquid containing the mucosal fluid adhered to the mucosal surface of the nasal cavity.
Claim 1 recited “the mucosal fluid”. There is insufficient antecedent basis for this recitation in the claim because there is no prior mention of this term in the claim. 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 mucosal washings adhered to the mucosal surface of the nasal cavity.
Claim 2 recited “the amount”. There is insufficient antecedent basis for this recitation in the claim because there is no prior mention of this term in the claims. For purposes of compact prosecution and applying prior art, claim 2 was herein interpreted as referring to an amount.
Claims 5 and 6 recite “The method according to Claim 1, which is a method of…” These recitations are unclear because claim 1 refers to a method for detecting. It is unclear if Applicant meant to add subsequent steps of immunological detection and/or gene amplification to the method of claim 1 or not. For purposes of compact prosecution and applying prior art, claims 5 and 6 was herein interpreted consistent with the Specification (pages 7-11) as referring to the method of claim 1 further comprising a step of immunological detection in claim 5 and a step of gene amplification in claim 6.
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US PG Pub 2023/0061094 A1 to Levitz et al. effectively filed on 05/06/2020. See PTO-892: Notice of References Cited.
See claims 1-6 as submitted on 01/12/2023.
Regarding claim 1, Levitz et al. teach a nasal-spray sampling method for detecting an infectious disease infection 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])
Regarding claim 2, Levitz et al. teach collecting the specimen comprising nasal washings after administering 500 microliters of nasal wash into the nostril (¶ [0886]) which lies within the claimed range.
Regarding claim 3, Levitz et al. teach applying a washing liquid into the nostril by spraying (¶ [0066]).
Regarding claim 4-6, 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]).
Conclusion
No claims are allowed.
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-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J Visone can be reached at (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672