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.
Response to Amendment
This Office Action is responsive to the amendment filed 12/01/2025 (“Amendment”). Claims 1-10 are currently under consideration. The Office acknowledges the amendments to claims 1, 2, and 5-9. Claims 11-20 remain withdrawn.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under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.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 Objections
Claim 1 is objected to because of the following informalities: the recitation of “first pretreatment” should instead read –first pre-treatment—for consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, it is unclear whether the polar VOC sensor array is part of the sensor array already described in claim 1, or is a different array.
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, 6, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US 2011/0023581 (“Chou”) in view of US 5,824,918 (“Zuk”) and Kim, Yong Shin, et al. "Gas sensor measurement system capable of sampling volatile organic compounds (VOCs) in wide concentration range." Sensors and Actuators B: Chemical 122.1 (2007): 211-218 (“Kim”).
Regarding claim 1, Chou teaches a disease diagnosis device comprising: a pump configured to pump exhaled respiratory gas (Fig. 1A, pump 112); a first pre-treatment portion connected to the pump and configured to remove moisture and odor-causing volatile compounds in the exhaled respiratory gas (Fig. 1A, at filter/valve 104, ¶¶s 0115-0120, dry filter assembly 1502 for filtering microbacteria, viruses, etc., and moisture removal module 1504 for filtering water vapor. Although it is not explicit that this is removing odor-causing volatile compounds, the removal of e.g. microbacteria suggests the removal of odor-causing volatile compounds); and a volatile organic compound (VOC) detection portion including a sensor array and connected between the first pre-treatment portion and the pump to detect VOCs present in the exhaled respiratory gas (Fig. 1A, detector array 110, ¶¶s 0003, 0045, 0097, etc.); …; and a control portion connected to the VOC detection portion[, and other elements of the assembly] (Fig. 1, control 126)…, wherein the first pre-treatment portion comprises: a first chamber (e.g. Fig. 16, the housing of module 1504, ¶ 0116); a moisture filter disposed in the first chamber to remove the moisture in the exhaled respiratory gas (¶ 0116, filtering water vapor using e.g. a salt compound); and an odor filter disposed between the moisture filter and the VOC detection portion to remove the odor-causing volatile compounds in the exhaled respiratory gas (Fig. 16, dry filter assembly 1502 including dry filter 1510, ¶¶s 0116, 0117), … .
Chou does not appear to explicitly teach a second pre-treatment portion disposed between the first pretreatment portion and the VOC detection portion and configured to adjust moisture of the exhaled respiratory gas, the control portion being configured to control the moisture of the exhaled respiratory gas in the second pre-treatment portion to a reference moisture, wherein the second pre-treatment portion is provided between the first chamber and the VOC detection portion and comprises a water bubbler configured to vaporize deionized (DI water).
Zuk teaches a water bubbler having a DI water bath 54, a hygrometer 22 (located after the water bubbler as shown in Fig. 2) to detect humidity, and a carrier gas supplier to supply carrier gas to the DI water bath to create DI water vapor by flowing the gas through the water (Fig. 2, col. 4, lines 4-41, col. 5, lines 50-59).
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 utilize a DI water bubbler as part of a humidity control system in Chou as in Zuk, located after the initial filter/valve 104 of Chou, for the purpose of controlling relative humidity of the sample, thereby achieving desirable conditions for testing/sensing (Zuk: Abstract).
Chou-Zuk does not appear to explicitly teach a third pre-treatment portion disposed between the second pre-treatment portion and the VOC detection portion and configured to adjust non-polar volatile organic compounds contained in the exhaled respiratory gas, the control portion being configured to control concentration of the nonpolar volatile organic compounds in the exhaled respiratory gas in the third pre-treatment portion to a reference concentration, wherein the third pre-treatment portion is provided between the water bubbler and the VOC detection portion and comprises a benzene bubbler configured to vaporize a benzene solution.
Kim teaches a benzene bubbler configured to evaporate a benzene solution (page 212, §§s 2.1 and 2.2, a vapor-generating bubbler based on e.g. benzene); and a non-polar volatile organic compound gas sensor to detect a benzene gas in the volatile organic compounds (Fig. 2; pages 212-213, § 2.3 Detection chamber and data acquisition). The concentration of benzene in the sample is controlled to a reference concentration (§ 2 describes controlling the output flow rate of the bubbler based on a predetermined vapor pickup efficiency and a determined carrier flow rate, that can then be used to determine an analyte concentration according to dilution flows).
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 a benzene bubbler and non-polar VOC detector as a third-pretreatment portion in the combination, as in Kim, and to use them to control the concentration of nonpolar VOCs in the sample, for the purpose of effectively sensing non-polar VOCs as well, including based on analyte dilution prior to sensing (Kim: Abstract, §§s 2.2. and 2.3, etc.; Chou: ¶ 0064). It would have been obvious to locate the benzene bubbler and detector between the water bubbler and the VOC detection portion, as a location that is obvious to try in the system (since there are only a few components that are to be arranged in series, with a reasonable expectation of success in detecting both polar and non-polar VOCs), and for the purpose of analyte dilution prior to sensing (Kim: § 2.2).
Regarding claim 6, Chou-Zuk-Kim teaches all the features with respect to claim 1, as outlined above. Chou-Zuk-Kim further teaches wherein the second pre-treatment portion further comprises a hygrometer disposed between the water bubbler and the VOC detection portion to detect moisture of the exhaled respiratory gas (Zuk teaches a hygrometer 22 located after the water bubbler as shown in Fig. 2, to detect humidity. It would have been obvious to incorporate the hygrometer as part of the humidity control system contemplated).
Regarding claim 8, Chou-Zuk-Kim teaches all the features with respect to claim 6, as outlined above. Chou-Zuk-Kim further teaches wherein the third pre-treatment portion comprises a non-polar VOC gas sensor disposed between the benzene bubbler and the VOC detection portion to detect the non-polar VOCs of the VOCs (Kim teaches a non-polar volatile organic compound gas sensor to detect a benzene gas in the volatile organic compounds (Fig. 2; pages 212-213, § 2.3 Detection chamber and data acquisition. It would have been obvious to incorporate a non-polar VOC detector as in Kim, for the purpose of effectively sensing and controlling the concentration of non-polar VOCs (Kim: Abstract, §§s 2.2. and 2.3, etc.; Chou: ¶ 0064).
Regarding claim 10, Chou-Zuk-Kim teaches all the features with respect to claim 1, as outlined above. Chou-Zuk-Kim further teaches wherein the VOC detection portion comprises a polar VOC sensor array (Chou: ¶¶s 0062, 0064, toluene, nonanal, etc., and any other VOC desired to be detected).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Chou-Zuk-Kim in view of US 2011/0203585 (“Cozean”).
Regarding claims 2 and 3, Chou-Zuk-Kim teaches all the features with respect to claim 1, as outlined above. Chou-Zuk-Kim does not appear to explicitly teach wherein the odor filter comprises metal powder, wherein the metal power comprises copper oxide or platinum.
Cozean teaches a bad breath filter comprising an adsorber that includes copper oxide (¶ 0013). The copper oxide is a powder (¶¶s 0081, 0082, 0084, small loosely packed particles – also see ¶ 0134).
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 copper oxide powder filter in the combination, as the simple substitution of one filtering arrangement for another with predictable results (Cozean: ¶ 0013, filtering undesired odors).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Chou-Zuk-Kim in view of US 4,478,619 (“Arends”).
Regarding claim 4, Chou-Zuk-Kim teaches all the features with respect to claim 1, as outlined above. Chou-Zuk-Kim does not appear to explicitly teach wherein the moisture filter comprises cotton.
Arends teaches using cotton to filter moisture (Abstract, col. 1, lines 43-46, etc.).
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 cotton in the moisture filter of the combination, as the simple substitution of one filtering arrangement for another with predictable results (Arends: Abstract, col. 1, lines 43-46, filtering moisture).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chou-Zuk-Kim in view of US 5,645,072 (“Thrall”).
Regarding claim 5, Chou-Zuk-Kim teaches all the features with respect to claim 1, as outlined above. Chou-Zuk-Kim does not appear to explicitly teach wherein the first pre-treatment portion comprises a first heater disposed in the first chamber and surrounding the moisture filter and the odor breath filter (although Chou: claims 40, 44, and 47 do describe using a heater to heat the moisture filter, thereby purging it).
Thrall teaches a heating block surrounding a gas tube, used to purge the tube (col. 4, lines 17-19, 27-43).
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 heater of Chou surround the filters, as in Thrall, for the purpose of providing uniform heating while not obstructing flow, to effectively purge adsorbed elements (Thrall: col. 4, lines 17-19, 27-43).
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chou-Zuk-Kim in view of US 2009/0275852 (“Oki”).
Regarding claim 7, Chou-Zuk-Kim teaches all the features with respect to claim 6, as outlined above. Chou-Zuk-Kim further teaches wherein the water bubbler comprises: a water bath configured to store the DI water (Zuk: Fig. 2, DI water supply 54), but does not appear to explicitly teach a first nitrogen supplier connected to the water bath and configured to generate vapor of the DI water by supplying a nitrogen gas into the DI water (although Zuk does teach using a compressed air gas source).
Oki teaches using nitrogen gas to generate an exhaled breath model gas by bubbling (¶ 0138).
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 generate the vapor of the combination using nitrogen gas, as in Oki, as the simple substitution of one gas for another with predictable results (Oki: ¶ 0138, generating vapor), and since it has been held to be within the ordinary skill of one in the art to select, as a matter of obvious design choice, a known material on the basis of its suitability for the intended use. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 9, Chou-Zuk-Kim teaches all the features with respect to claim 8, as outlined above. Chou-Zuk-Kim further teaches wherein the benzene bubbler comprises: a benzene bath configured to store the benzene solution (Kim: Figs. 1(b) and 2 – also see § 2.1, vaporizing liquid VOCs), but does not appear to explicitly teach a second nitrogen supplier connected to the benzene bath and configured to generate the benzene gas by supplying a nitrogen gas into the benzene solution.
Oki teaches using nitrogen gas to generate an exhaled breath model gas by bubbling (¶ 0138).
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 generate the gas/vapor of the combination using nitrogen gas, as in Oki, as the simple substitution of one gas for another with predictable results (Oki: ¶ 0138, generating vapor), and since it has been held to be within the ordinary skill of one in the art to select, as a matter of obvious design choice, a known material on the basis of its suitability for the intended use. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Response to Arguments
Applicant’s arguments filed 12/01/2025 have been fully considered.
It is true that Chou does not teach all features of the claims, but the rejections are based on a combination. Applicant has not addressed the teachings of Zuk and Kim that were previously cited with respect to claims 6 and 8.
Further, the Office disagrees that Chou teaches only a single pretreatment module. Fig. 1 shows use of a filter and valve assembly 104 as well as a pre-concentrator 106. Chou also describes filtering particles and moisture, which can occur in different stages. Thus, it contemplates more than one stage of sample treatment.
Regarding Zuk and Kim, the Office does not see where the devices are described as passive devices. Actually, Zuk performs active and precise humidity control based on varying conditions, and Kim actively controls different variables to achieve a desired result. Thus, all claims remain rejected in light of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791