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 November 6, 2025 were received and fully considered. No claims were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 6, 2025 has been entered.
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.
Claims 1, 3, 5, 6, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Purves (US PG Pub. No. 2018/0214050 A1), Giron et al. (US PG Pub. No. 2005/0177056 A1) (hereinafter “Giron”), and Jaffe et al. (US PG Pub. No. 2008/0041172 A1) (hereinafter “Jaffe”).
Purves, Giron, and Jaffe were applied in the previous office action.
With respect to claims 1 and 6, Purves teaches an apparatus and method for collecting a breath sample (title, abstract), comprising: a breath input interface configured to receive exhaled breath (par.0033 “gas inlet 4 (e.g. gas intake component, or mouthpiece)”; see Fig. 1); a first conduit system connected to the breath input interface (collection portion 20 in Fig. 1), the first conduit system including a breath intake conduit extending between the breath input interface and a receptacle configured to capture at least some of the exhaled breath (gas collection line Lc depicted in Fig. 1); at least one metering device for measuring at least one characteristic (flowmeter 6 in Fig. 1; see par.0034-35), the at least one metering device being positioned along an exhaust conduit of the first conduit system that branches from the breath intake conduit (flowmeter 6 is positioned along exhaust line Le as depicted in Fig. 1), the at least one metering device including a flow meter configured to measure a flow rate of the exhaled breath along the exhaust conduit of the first conduit system (flowmeter 6 measures flow rate of the exhaled breath along Le; see Fig. 1; par.0055 “device 6 continues to measure a positive flow rate through the exhaust portion 10”).
However, Purves does not teach at least partially flexible collapsible receptacle, a pump positioned along the breath intake conduit, and a controller configured to control the pump to draw exhaled breath into the at least partially flexible collapsible receptacle at a rate that is proportional to the flow rate measured by the flow meter when breath is being captured in the at least partially flexible collapsible receptacle.
Giron teaches at least a partially flexible collapsible receptacle (par.0077 “collection containers are preferably in the form of gas-tight bags, which are initially flat at the beginning of the test, and each of which is sequentially filled by the inflow of the breath sample directed to that container”), a pump positioned along the breath intake conduit (pump 16 is positioned along the collection line, see Fig. 1), and a controller (controller 14 in Fig. 1) configured to control the pump to draw exhaled breath into the at least partially flexible collapsible receptacle when breath is being captured in the at least partially flexible collapsible receptacle (controller 16 controls pump 16 in order to collect exhaled breath into sample containers 24; see Fig. 1; par.0071).
Jaffe teaches control the pump to draw exhaled breath into the receptacle at a rate that is proportional to the flow rate measured by the flow meter when breath is being captured in the receptacle (par.0087 “In obtaining readings of the characteristics of one or more components of a patient's exhaled breath over a period of time, it is desirous that the flow of gas through gas sampling circuit 102 is maintained at a constant rate. Therefore, during any of the operations of process 500, flow measurement device 109 may be utilized to measure the flow of gas through gas sampling circuit and convey information regarding the flow of gas through gas sampling circuit 102 to control center 117. This information may be utilized to adjust pump 113 to maintain a constant flow of gas through gas sampling circuit 102 under different load conditions”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Purves to utilize partially flexible collapsible receptacle as doing so would be a simple substitution (using collection airbags in place of rigid containers) that has been set forth in the art, as evidence by Giron (par.0077). Furthermore, PHOSITA would have had predictable success when the invention was filed modifying Purves to incorporate a pump positioned along the breath intake conduit in order to guide exhaled breath into downstream sample containers, as evidence by Giron (Fig.1; par.0071). Additionally, it would have been obvious to PHOSITA to modify Purves and Giron when the invention was filed to incorporate the step of control the pump to draw exhaled breath into the receptacle at a rate that is proportional to the flow rate measured by the flow meter when breath is being captured in the receptacle as it is desirous that the flow of gas through the gas sampling circuit it maintained at a constant rate under different load conditions, as evidence by Jaffe (par.0050, 0087). Lastly, PHOSITA would have had predictable success when the invention was field to combine Purves, Giron, and Jaffe since all teachings relate to the same narrow field of endeavor, i.e. collecting exhaled breath for analysis purposes.
With respect to claims 3 and 8, Purves teaches the at least one metering device includes a capnometer positioned along the exhaust conduit of the first conduit system to measure a carbon dioxide level in the exhaled breath (capnometer 8 is positioned along exhaust line Le; see Fig. 1; par.0034).
With respect to claims 5 and 10, Purves teaches an exhaust pump positioned along the exhaust conduit of the first conduit system to flow air through the exhaust conduit (exhaust pump 7 positioned along exhaust line Le; see Fig. 1; par.0037).
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Purves, Giron, and Jaffe, as applied to claims 1 and 6 above, in further view of Cranley et al. (US PG Pub. No. 2002/0007249 A1) (hereinafter “Cranley”).
Cranley was applied in the previous office action.
With respect to claims 4 and 9, Purves, Giron, and Jaffe teach an apparatus and method for collecting a breath sample, as established above.
However, Purves, Giron, and Jaffe do not teach the limitations recited in claims 4 and 9.
Cranley teaches the at least one metering device includes a hygrometer positioned along the exhaust conduit of the first conduit system to measure a humidity level in the exhaust conduit (par.0025).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Purves, Giron, and Jaffe to utilize a hygrometer in order to determine more information from obtained exhaled breath sample, as evidence by Cranley (par.0025).
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but they were not persuasive. Applicant continues to argue that Jaffe, the maintained secondary reference, does not teach and/or suggest “control the pump to draw exhaled breath into the at least partially flexible collapsible receptacle at a rate that is proportional to the flow rate measured by the flow meter when breath is being captured in the at least partially flexible collapsible receptable” (emphasis added). As was similarly argued in the previous remarks, applicant takes issue with Jaffe’s [0087] and now also contends that Jaffe discloses drawing exhaled breath at a rate that is inversely related to the rate of the flow of gas (see pg. 6 of the remarks filed on 11/6/2025). While Examiner does not necessarily agree, it is noted that a purported inverse relationship between values would still nonetheless equate to a proportional relationship between said values, when considering broadest reasonable interpretation. For instance, A = 1/B suggests that A and B are still proportional to each other. Moreover, nothing from the claims, as currently constructed, requires a direct relationship between the pump rate and the breath flow rate.
For at least these reasons, the obviousness rejections are maintained.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791