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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/16/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 07/16/2026. Claims 1, 3-7, 9, and 10 are currently under consideration. The Office acknowledges the amendment to claim 1.
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under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Priority
This application appears to disclose and claim only subject matter disclosed in prior application no. 15/917,225, filed 03/09/2018, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a continuation or division (as opposed to a continuation-in-part, as described in the Application Data Sheet of 01/28/2021. Also see ¶ 0001 of the specification as filed, which describes the application as a continuation). If not, the Office requests Applicant to highlight the newly added subject matter. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq.
Information Disclosure Statement
Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
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 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2016/0174875 (“Forster”) in view of US Patent 5,573,005 (“Ueda”), US Patent Application Publication 2013/0303929 (“Martino”), and non-patent publication Sakata, Derek J., et al. "Flow-through versus sidestream capnometry for detection of end tidal carbon dioxide in the sedated patient." Journal of clinical monitoring and computing 23 (2009): 115-122 (“Sakata”).
Regarding claim 1, Forster teaches [a]n apparatus for collecting a gas sample (Title), the apparatus comprising: a gas inlet for receiving the gas sample (Fig. 1, mouthpiece 11); a gas collection line extending from the gas inlet towards at least one thermal desorption tube for capturing volatile organic compounds from the gas sample (Fig. 1, the portions including cylinder 27, piston 28, and adsorption tube 24 are used for gas sampling, so the gas collection line is the tubing running from the mouthpiece to these components - also see ¶¶s 0003, 0004); and an exhaust line extending from the gas collection line (Fig. 1, elements 17-19 being one exhaust line and the tubing leading to pump 34 being another exhaust line, both extending from the gas collection line), the exhaust line having an outlet portion with unidirectional flow away from the gas collection line (Fig. 1, via valve 18 towards outlet 19. Also note that pump 34 is another outlet with unidirectional flow away from the gas collection line, since ¶¶s 0042, 0046, etc. describe the pump as sucking air through the system), … .
Forster does not appear to explicitly teach the outlet portion having a flowmeter positioned on the outlet portion of the exhaust line for measuring a flow rate of the gas sample (although Forster does teach a flow meter in the same vicinity - flow sensor 15).
Ueda teaches an exhaust portion extending, via an exhaust line, from a gas collection line, the exhaust portion having a flowmeter positioned thereon (Fig. 1, flow sensor 20 located on the exhaust line defined by expiration outlet 16 and switching valve 18).
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 rearrange the flowmeter of Forster by putting it onto e.g. the first outlet portion, as in Ueda, as an obvious rearrangement of parts that would accomplish the same result (Ueda: col. 5, lines 31-54, enabling control of at least valve 18 to collect end-tidal air in the syringe 12 while discarding the rest - this is similar to what is described in ¶ 0027 of Forster). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Forster-Ueda does not appear to explicitly teach a capnometer fully positioned on the outlet portion of the exhaust line, and spaced from the gas collection line, for measuring and monitoring at least one physical characteristic of the gas sample for distinguishing between a gas sample that includes alveolar breath and a gas sample that includes non-alveolar breath, such that the gas sample that includes non-alveolar breath is directable out of the exhaust line for venting from the apparatus, and the gas sample that includes alveolar breath is directable to the gas collection line.
Martino teaches a capnometer positioned on an exhaust line extending from a gas collection line, and also teaches the exhaust line having a unidirectional outlet portion (Fig. 1, carbon dioxide detector 44 is positioned on the exhaust line defined by discharge valve 64, the valve 64 being unidirectional because it is for “discharge”). Martino teaches that its capnometer can control which part of an exhalation is sampled/stored, including leading and trailing portions (¶¶s 0033, 0035, 0017, etc.).
Sakata teaches that sidestream capnometry (compare to Applicant’s description of “side-sampling” in ¶ 0035 of the specification as filed) is as effective as flow-through capnometry under most circumstances (Abstract), with sidestream capnometry taking the breath sample to a separate location for measurement (Fig. 2).
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 incorporate the carbon dioxide detector of Martino onto the first outlet portion of Forster, for the purpose of being able to distinguish between different parts of the breath sample to thereby collect alveolar gas rather than dead space gas, as already contemplated (Forster: ¶ 0027), in a more precise manner than simply relying on volume measurements (Martino: ¶¶s 0025, 0026, allowing specificity based on waveform shape). This includes distinguishing between alveolar and non-alveolar portions to collect e.g. the alveolar portion (Martino: ¶¶s 0033, 0035, 0017, etc.). It would have been obvious to incorporate the carbon dioxide detector of Martino in a sidestream arrangement, as in Sakata, as the simple substitution of one known arrangement for another with predictable results (Sakata: Abstract, similar efficacy; Introduction, enabling use of a more durable and easy-to-use capnometer).
Regarding claim 3, Forster-Ueda-Martino-Sakata teaches all the features with respect to claim 1, as outlined above. Forster-Ueda-Martino-Sakata further teaches wherein the outlet portion includes at least one venting gas outlet for venting some or all of the gas sample from the apparatus (Forster: ¶¶s 0037, 0044, gas outlet 19 via second valve 18 - Fig. 1).
Regarding claim 4, Forster-Ueda-Martino-Sakata teaches all the features with respect to claim 1, as outlined above. Forster-Ueda-Martino-Sakata further teaches wherein the outlet portion further includes a pump and at least one pump gas outlet, and wherein the pump is controllably activated to draw ambient air through the exhaust line and out at least one second gas outlet to flush the exhaust line (Forster: Fig. 1, pump 34 having a pump gas outlet as well as an associated second gas outlet (e.g. in the housing of the device), ¶ 0042).
Regarding claim 5, Forster-Ueda-Martino-Sakata teaches all the features with respect to claim 1, as outlined above. Forster-Ueda-Martino-Sakata further teaches wherein the apparatus further comprises at least one auxiliary gas inlet port positioned to allow an inflow of ambient air into the apparatus when there is a negative pressure therein (Martino: an auxiliary gas inlet port for allowing the patient to inhale filtered air (e.g. filtering substances that are not VOCs) before providing an exhaled breath sample (Fig. 1, room air traveling through filter 18 and valve 42 to reach the patient - ¶ 0024). When the patient inhales to draw the air in, this creates the negative pressure. 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 incorporate an auxiliary port like that of Martino into the combination, for the purpose of filtering out non-VOC substances from the air sample, thereby enabling collection of better breath samples (Martino: Abstract, ¶ 0024)).
Regarding claim 6, Forster-Ueda-Martino-Sakata teaches all the features with respect to claim 1, as outlined above. Forster-Ueda-Martino-Sakata further teaches at least a first gas collection portion positioned on a first branch of the gas collection line (Forster: Fig. 1, the first branch containing the cylinder 27 and piston 28), the first gas collection portion including a gas collection chamber for receiving a portion of the gas sample (Forster: Fig. 1, respiratory gas temporary storage volume 43), the gas collection chamber having a reciprocating piston therein (Forster: Fig. 1, piston 28), the reciprocating piston connected to a drive mechanism for actuating the reciprocating piston within the gas collection chamber (Ueda teaches a piston similar to that of Forster being operated via a driving mechanism including a motor 22 (Fig. 1). It would have been obvious to incorporate a motor to drive the piston of Forster, as in Ueda, because such a modification would only be the automating of a manual activity. See MPEP 2144.04 (III) and Ueda (col. 5, lines 45-54)) between a compressed position and a decompressed position to draw the portion of the gas sample into the gas collection chamber and to expel at least some of the portion of the gas sample in the gas collection chamber (Forster: ¶¶s 0045, 0046).
Regarding claim 7, Forster-Ueda-Martino-Sakata teaches all the features with respect to claim 6, as outlined above. Forster-Ueda-Martino-Sakata further teaches wherein the drive mechanism comprises a motor (Ueda: Fig. 1, motor 22).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Forster-Ueda-Martino-Sakata in view of US Patent Application Publication 2003/0109794 (“Phillips”).
Regarding claim 9, Forster-Ueda-Martino-Sakata teaches all the features with respect to claim 1, as outlined above. Forster-Ueda-Martino-Sakata does not appear to explicitly teach wherein the at least one thermal desorption tube is configured to enable at least nitrogen, oxygen, water, and carbon dioxide from the at least one gas sample to pass through (although ¶ 0049 of Forster does describe its tube 24 adsorbing hydrocarbons and reducing the adsorption of water).
Phillips teaches a device who purpose is to concentrate volatile organic compounds in alveolar breath while allowing nitrogen, oxygen, and carbon dioxide to escape unhindered (¶ 0013). It also teaches that its sorbent trap can use e.g. Tenax (¶ 0027 - this is the same material contemplated by ¶ 0045 of Applicant’s specification).
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 make the thermal desorption tube of the combination like that of Phillips, for the purpose of concentrating volatile organic compounds in alveolar breath while allowing nitrogen, oxygen, water, and carbon dioxide to escape unhindered (Phillips: ¶ 0013; Forster: ¶ 0049).
Regarding claim 10, Forster-Ueda-Martino-Sakata teaches all the features with respect to claim 1, as outlined above. Forster-Ueda-Martino-Sakata does not appear to explicitly teach an ambient air component connected to the gas collection line and having a first ambient air intake to collect and sample ambient air from the environment.
Phillips teaches a gas collection and sampling portion comprising an ambient air component having a first ambient air intake to collect and sample ambient air from the environment (Fig. 1, air going into valve selector 60, for collecting an ambient air sample - ¶¶s 0025, 0027).
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 incorporate ambient air sampling into the combination, via e.g. another inlet and adsorption tube (as in Phillips), for the purpose of enabling comparison of breath VOCs with a baseline (Phillips: ¶ 0029).
Response to Arguments
Applicant’s arguments filed 07/16/2026 have been fully considered, but they are not persuasive.
In Forster, the throttle is part of the flow sensor itself - flow is calculated based on the pressure difference through the throttle (¶ 0036). Thus, moving the sensor contemplates moving the throttle as well. And, it should be noted that this sensor can simply be replaced with the one of Ueda. Forster’s function would still be achieved, since Ueda shows that sample separation can be achieved with a flow meter along an exhaust line. Applicant should not ignore the teachings of Ueda, presented here and argued in the previous response on 03/19/2026.
Further, fully positioning a capnometer on an outlet portion of an exhaust line, i.e., side-stream, is known in the art. The combination above teaches it. Applicant may also refer to e.g. US Patent Application Publication 2017/0325716 (“Coleman”), which teaches the location of both a flow sensor and capnometer side-stream (Fig. 2, sensors 260 and 240 - note this disclosure was available before Applicant’s own disclosure of the side-stream aspect on 03/09/2018). Regarding distinguishing between alveolar and non-alveolar breath, it is true that Martino teaches the ability to discard the trailing portion of a sample. But it also teaches the ability to discard the leading portion of the sample. I.e., when using a capnometer, it is possible to select any portion along the capnograph for sampling. Forster and Ueda also describe collecting an end-tidal portion (Forster: ¶ 0027; Ueda: Abstract, col. 5, lines 31-54).
Applicant has generally not distinguished their claim from side-stream capnometry.
All claims remain rejected in light of the prior art.
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
