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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/25/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 02/25/2025. Claims 1, 3-7, 9, and 10 are currently under consideration. The Office acknowledges the amendment to claim 6.
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under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.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.
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”).
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). 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 02/25/2026 have been fully considered, but they are not persuasive.
In Forster, the Office agrees that the flow meter is to enable discarding of the first portion of a breath sample. But, this function would be achieved even if the flow sensor was moved to the first outlet portion. I.e., the flow meter need not measure flow through a throttle, as in Forster, since Ueda shows that sample separation can be achieved simply with a flow meter at the outlet. Based on the teachings of Ueda, it is evident that a throttle is not needed to achieve the function of flow gating. Forster would thus continue to be satisfactory for its intended purpose. In any case, the throttle could also be moved to the outlet portion. The point is that there is some means of measuring flow at the outlet portion, to control which portion of a sample gets discarded. The art contemplates this.
The Office disagrees that Forster is not concerned with monitoring flow rate in relation to its outlet portion. The whole reason to use the flow meter and throttle is to discard certain portions of the breath sample. Forster’s arrangement is simply one way to achieve this function. Ueda teaches another way to achieve this function, which is by moving the flow meter to the outlet portion. Further, it should be noted that Forster need not contemplate all the possible modifications that could be made to it. The motivation for modification can come from a secondary reference, such as Ueda.
Regarding Martino, it is unclear why Applicant thinks it does not teach what is was cited for. The Office has not stated, for example, that the capnometer is spaced from the gas collection line. It is simply on the exhaust line (as shown in Fig. 1). Sakata teaches spacing the capnometer via a sidestream arrangement. Applicant takes one sentence from Sakata and uses it to try to discredit sidestream capnometry. But the Office has already cited various portions of Sakata which describe the usefulness of sidestream capnometry. And the Office reiterates - Sakata does not assert that sidestream capnometry is not favorable to flow-through capnometry. The two types of capnometry are simply used in different situations. The results and conclusions sections of the Abstract of Sakata explains that Bland and Altman plots show essentially equal performance between the two capnometers in volunteers, and that the two capnometers also perform equally well during bench testing and in non-intubated, sedated patients. There is no criticism/discouragement/disparagement of sidestream capnometry.
Applicant argues that Martino has no need for spacing the capnometer, but as already noted above, the motivation for combination can come from another reference.
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