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 . 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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/06/2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 11/06/2025 (“Amendment”). Claims 1-3 and 15-25 are currently under consideration. Claims 4-13 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 103
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.
Claims 1-3 and 15-25 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2018/0214050 (“Purves”) in view of US Patent Application Publication 2016/0345859 (“Weda”), US Patent Application Publication 2016/0242674 (“Ahmad”), and US Patent Application Publication 2006/0173580 (“Desrochers”).
Regarding claim 1, Purves teaches [a]n apparatus for collecting a breath sample (Title), comprising: a breath input interface configured to receive exhaled breath (Fig. 1, gas inlet 4, which may be a mouthpiece as described in ¶ 0033); a container connected to the breath input interface … for storing at least some of the exhaled breath (Fig. 1, collection component 20a - see ¶ 0040); at least one metering device for measuring at least one characteristic (Fig. 1, gas volume measurement device 6), the at least one metering device being positioned along an exhaust conduit of a first conduit system (Fig. 1, along exhaust portion 10), the exhaust conduit branching from a breath intake conduit of the first conduit system, the breath intake conduit extending from the breath input interface (Fig. 1, branching from a conduit positioned after inlet 4), 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 (¶¶s 0034 and 0055, where gas volume measurement device 6 is a flowmeter that measures flow rate) … and at least one controller (¶ 0050, automatic control via microprocessor 200) configured to control … a flow of the at least some of the breath from the container to at least one sorbent tube (Fig. 1, sampling devices 30 being sorbent tubes - see ¶ 0045) connected to the container asynchronous of when the breath is received (¶ 0030, collecting gas in 20a and then delivering it to 20b) … .
Purves does not appear to explicitly teach the container including an at least partially flexible collapsible receptacle, or a two-way pump connected to the breath intake conduit and the container to draw the at least some of the exhaled breath into the container from the breath input interface via the breath intake conduit, and from the container. Purves further does not appear to explicitly teach the controller configured to control the two-way pump to draw the at least some of the exhaled breath into the at least partially flexible collapsible receptacle at a rate based on the flow rate measured by the flow meter when the at least some of the exhaled breath is being captured in the at least partially flexible collapsible receptacle (although Purves does describe the gas volume measurement device 6 being used to trigger actuation of piston 24 to begin retracting and collecting a breath sample, and then precisely controlling it to move the sample to a sampling device 30: ¶¶s 0055-0058. I.e., this is the same functionality claimed, except using a piston and motor rather than an air bag and pump).
Weda teaches using an air bag together with a sorbent tube to collect a breath sample. After the patient breaths into the air bag, the contents are pushed or pulled through the sorbent tube with a pump (¶ 0017).
Ahmad teaches using a reversible pump to both push and pull a breath sample (¶ 0369).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the collection component 20a of Purves with an air bag and pump, as in Weda, as the simple substitution of one know collection component for another with predictable results (Weda: ¶ 0017, the bag usable for collecting a breath sample and then delivering it to a sorbent tube). It would have been obvious to use the pump to perform the control already contemplated by Purves, for the purpose of precisely controlling the gas coming in and out of the air bag and to avoid the creation of negative pressure (Purves: ¶ 0055, obtaining precise control and a positive flow rate throughout sampling). It would have been obvious to further configure the pump of the combination as a reversible or two-way pump, as in Ahmad, enabling the pump to flow air into the air bag based on control of the pump and inlet valve as well as to push the air out to the sorbent tubes, for the purpose of more precisely and efficiently controlling the breath sample (Ahmad: ¶ 0369, compact, fewer valves, etc.; ¶ 0368, decoupling the force of exhalation from the pressure required to fill the container, thus increasing a range of applications), achieving the control already contemplated by Purves with a two-way pump and an air bag instead of a motor and piston.
Purves-Weda-Ahmad does not appear to explicitly teach the controller configured to control the two-way pump to control the flow at one of at least two breath flow rates at which the at least one controller can control the two-way pump to draw the at least some of the exhaled breath from the container.
Desrochers teaches controlling a pump’s air flow rate via a variable speed pump control to achieve a desired flow rate for different devices including a radon detector, grab sampler, and particle detector (i.e., the flow rate is based on the load; Fig. 1A and ¶ 0051, also contemplating controlling flow rate individually).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a variable speed two-way pump in the combination and to control it to achieve different breath flow rates as in Desrochers, for the purpose of being able to tailor the air flow rate to the particular device attached in the system (Desrochers: ¶¶s 0050, 0051; e.g. based on brand of sorbent tube, whether an ambient sample is being captured, etc. ).
Regarding claim 2, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 1, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein the at least partially flexible collapsible receptacle has a cavity in which the at least some of the breath is stored, a volume of the cavity being controllable (Weda: ¶ 0017, the bag has a cavity for holding the breath sample, and its volume may be controlled by pumping the breath out).
Regarding claim 3, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 2, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein the volume of the cavity is controllable by the at least one controller via the two-way pump (Purves: ¶ 0050, the microprocessor controlling the pump, which is now the pump of Weda and Ahmad as modified by Desrochers).
Regarding claim 15, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 1, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein a second conduit system connects the two-way pump to the at least one sorbent tube (Purves: Fig. 1, the lines/tubing shown between gas collection component 20a and sampling component 20b).
Regarding claim 16, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 15, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein the at least one sorbent tube is at least two sorbent tubes (Purves: Fig. 1, multiple sampling devices 30), and wherein the two-way pump controlled by the at least one controller impels the at least some of the breath from the container through a subset of the at least two sorbent tubes (Weda: ¶ 0017, the pump arranged for pushing the air through the sorbent tube - also see Purves: ¶ 0057, passing the gas through one or more of the sorbent tubes).
Regarding claim 17, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 16, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches at least two tube inlet valves, each of the at least two tube inlet valves being positioned between the container and a corresponding one of the at least two sorbent tubes (Purves: Fig. 1, valves 35).
Regarding claim 18, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 17, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein the at least one controller is configured to control each of the at least two tube inlet valves to select the subset of the at least two sorbent tubes through which the at least some of the breath is flowed (Purves: Fig. 1, valves 35, ¶¶s 0046, 0057, etc.).
Regarding claim 19, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 16, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein the two-way pump is positioned between a valve and the container, and the at least one controller is configured to control the two-way pump to draw the at least some of the exhaled breath into the container (it would have been obvious to use the two-way pump of the combination to draw breath into the container (as well as to push it out to the sorbent tubes), by implementing two-way functionality between e.g. the valve 2 of Purves and the air bag/container (replacing e.g. the piston 24 of Purves), for the purpose of more precisely and efficiently controlling the breath sample (Ahmad: ¶ 0369, compact, fewer valves, etc.; ¶ 0368, decoupling the force of exhalation from the pressure required to fill the container, thus increasing a range of applications), the location being suitable for making the device more compact as described in ¶ 0369 of Ahmad).
Regarding claim 20, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 16, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein the subset is a first subset, and wherein the apparatus further comprises an inlet valve (Purves: Fig. 1, valve 42) positioned along the second conduit system between an inlet and the container (Purves: Fig. 1, between the ambient air entrance to component 20c and component 20a), and wherein the at least one controller is configured to close the inlet valve and control the two-way pump to flow air from the container through a second subset of the at least two sorbent tubes (Purves: ¶ 0054, valve 42 being closed unless it is desired to collect an ambient air sample - see ¶¶s 0049 and 0060 (i.e., the breath sample and ambient air are not pumped at the same time). Flowing air through the second subset is inherent in the use of separate valves 35 for each sorbent tube, and based on the collection of an ambient air sample).
Regarding claim 21, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 20, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein the at least one controller is configured to open the inlet valve and control the two-way pump to flow air through the inlet and into a cavity of the at least partially flexible collapsible receptacle (Purves: ¶ 0048. It would have been obvious to use the two-way pump of the combination to draw both breath and ambient air into the container, including from an ambient source such as the ambient air component 20c of Purves (as described in ¶ 0048, e.g. for the purpose of obtaining a control sample), by implementing two-way functionality between e.g. the valve 2 of Purves and the air bag/container (replacing e.g. the piston 24 of Purves), for the purpose of more precisely and efficiently controlling the breath sample (Ahmad: ¶ 0369, compact, fewer valves, etc.; ¶ 0368, decoupling the force of exhalation from the pressure required to fill the container, thus increasing a range of applications), the location being suitable for making the device more compact as described in ¶ 0369 of Ahmad).
Regarding claim 22, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 20, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein a tube inlet valve is positioned between the container and each of the at least two sorbent tubes (Purves: Fig. 1, valves 35).
Regarding claim 23, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 22, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein the at least one controller is configured to control each of the at least two tube inlet valves to select the first subset of the at least two sorbent tubes through which the at least some of the breath is flowed (Purves: inherent in the use of separate valves 35 for each sorbent tube - also see ¶ 0057, passing the gas through one or more of the sorbent tubes).
Regarding claim 24, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 3, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches a valve along the breath intake conduit intermediate the breath input interface and the two-way pump (Purves: Fig. 1, valve 2).
Regarding claim 25, Purves-Weda-Ahmad-Desrochers teaches all the features with respect to claim 24, as outlined above. Purves-Weda-Ahmad-Desrochers further teaches wherein the at least one sorbent tube is at least two sorbent tubes (Purves: Fig. 1, multiple sampling devices 30), and wherein the at least one controller is configured to control the valve to close and control the volume of the container via the two-way pump to impel the at least some of the breath through a subset of the at least two sorbent tubes upon capturing a target volume of the breath in the container (Purves: ¶ 0057, closing valve 2 once a sufficient volume of gas is collected within chamber 22, and then passing the gas through one or more of the sorbent tubes).
Response to Arguments
Applicant’s arguments filed 11/06/2025 have been fully considered.
In response to the arguments regarding the rejections under 35 USC 103, they are not persuasive. Applicant argues e.g. regarding size and portability of the device. These arguments are not necessarily tied to the claims since the claims do not require any particular size or degree of portability. And, the specification itself does not support the idea that using a collapsible bag would result in a smaller and more portable device. Indeed, most of the specification focuses on an arrangement that uses a piston, not the collapsible bag. It is not evident that the device of Purves (the primary reference) is quite heavy and large, and not suitable for transport to the locations of patients. Purves does not mention these things.
Regarding Applicant’s other points, it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). For example, Applicant must consider the teachings of Purves and Ahmad in addition to those of Weda. Taking Weda on its own is inappropriate. Further, a specific teaching is taken from Weda, and not the entire reference. Applicant has not argued that that specific teaching (cited above) is not found in Weda. The same applies to the other references. They include specific teachings that were cited by the Office. In combination, these teachings make the claimed device obvious. For example, it is immaterial that “transportation of the plurality of bags [of Weda would be] onerous.” Besides this language not being tied to the claims, Weda is simply used to teach use of an air bag together with a sorbent tube to collect a breath sample, and that after the patient breaths into the bag, the contents are pushed or pulled through the sorbent tube with a pump. I.e., it teaches that for which it was cited. Other relevant teachings are found in the other references. One of ordinary skill would not have “only considered transporting a breath sample via a bag to the device of Purves in place of a patient providing the breath sample online.” This ignores the teaching of Weda of using a pump to flow a sample from a bag to a sorbent tube. Weda was not used to teach control of flow rate – Desrochers was. And in this context, the reversible pump of Ahmad cannot be ignored.
Applicant then argues against Ahmad, but in a way that ignores the teachings of e.g. Purves and the other references. And, the fact remains that Ahmad teaches what it was cited for (using a reversible pump to both push and pull a breath sample).
Regarding the concept of drawing a breath sample into a container and then out to a sorbent tube, this is found in Purves. I.e., the concept of “temporarily caching” a breath sample is known. And the means by which this is done would have been obvious as noted above. Thus, all claims remain rejected in light of the prior art.
Conclusion
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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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791