DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/24/2026 has been entered.
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-9, 11-15, 17-19, 26 are pending.
This action is Non-Final.
Specification
The amendments filed 2/24/2026 are not entered as the amendments filed 10/14/2025 correct all objections raised. This is consistent with the interview discussions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 11-15, 17-19, 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitations “a handle for holding the device, wherein the sample container and sampler are housed within the handle” is rejected for containing new matter in view of the requirements of claim 1 including:
“a sampler, comprising:
a distal portion configured to protrude into a flow of breath from the mask or mouthpiece,
a sampler opening in the distal portion for obtaining a breath sample; and
a sample container in communication with the sampler for receiving the breath sample from the sampler;”
The issue is with regards to which elements have support for being housed within the handle as is being set forth in the claim. Under a broadest reasonable interpretation, each element falls into the scope of being housed within the handle. This would include the sampler, which includes the distal portion and the sampler opening, and the sample container. However, in review of the disclosure as filed, it is clear that the sample container is supported for being housed within the handle (“The handle 120 houses the sample container 113, which receives a breath sample from the flow of breath into the mask 101”), but there is no explicit recitation that the sampler is housed within the handle at any point in the assembling, taking samples, or disassembled form of the sample container. The closest passage is original claim 10 where such components are “housed by” the handle, but this is a broader form of structural arrangements between such components and the handle where housed by does not require housed within. Furthermore in review of the drawings, at no point are the distal portion and sampler opening within the handle, including Figures
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Figure 1
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Figure 5
For these reasons the claims as amended contain new matter and one of skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed. One option has been discussed with applicant to include the arrangement related to the mask or mouthpiece to overcome this rejection. Another option that time did not allow for would be to claim a handle for holding the device, wherein the sample container is housed within the handle and the sampler is housed by the handle.
The dependent claims are rejected for depending on a rejected claim.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims and specification filed 2/24/2026.
Applicant’s arguments regarding the specification objections have been fully considered, however, after further review appear to be unnecessary as the amendments filed 10/14/2025 correct paragraph 111 as filed and added a paragraph prior to 111. As such, these amendments do address the issues previously raised. As such, the objection is withdrawn, and the amendments filed to the specification on 2/24/2026 are not entered because they are unnecessary.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered and are persuasive due to the amendments to the claims to include the components within the handle as set forth in the claims; the rejections are withdrawn.
Conclusion
No prior art rejections have been applied, but the claims are not in condition for allowance due to the rejections under 35 U.S.C. 112(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791