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.
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 § 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.
Claims 4 and 5 are 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 pre-AIA the applicant regards as the invention.
Regarding claim 4, it is unclear because it depends from itself. This is circular. For purposes of examination, it will be interpreted as depending from claim 3.
Claim 5 is rejected because it depends on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6, 7, and 10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US Patent Application Publication 2019/0099109 (“Ahmad”).
Regarding claim 1, Ahmad discloses [a] mouthpiece comprising: a body (Fig. 4, the housing); a body conduit through the body of the mouthpiece (Fig. 4, the conduit within the housing), the body conduit comprising a breath inlet (Fig. 4, at input opening 22), and a sample air flow outlet (Fig. 4, at skirt 20 - ¶ 0045); a desiccant within the body conduit (Fig. 4, desiccant filter 30); and a check valve within the body conduit (Fig. 4, one-way valve 28), wherein the mouthpiece is operable to receive air flow from a breath of a user at the breath inlet and pass at least a sample of the air flow out the sample air flow outlet (¶¶s 0044, 0045), and wherein the check valve is operable to prevent backflow of the air flow to the user (¶ 0045).
Regarding claim 2, Ahmad discloses all the features with respect to claim 1, as outlined above. Ahmad further discloses wherein the desiccant is operable to remove liquid from the air flow, such that the desiccant reduces the humidity of the air flow sample as compared to the air flow from the breath (¶ 0045).
Regarding claims 3 and 4, Ahmad discloses all the features with respect to claim 1, as outlined above. Ahmad further discloses a filter within the body conduit, wherein the filter is operable to remove particles from the air flow before the air flow sample reaches the sample air flow outlet (Fig. 4, particle filter 26).
Regarding claims 6 and 7, Ahmad discloses all the features with respect to claim 1, as outlined above. Ahmad further discloses wherein the sample air flow outlet is configured to be coupled to a cassette inlet of a cassette comprising a biosensor including a plurality of graphene-based sensors and the biosensor is operable to detect at least one volatile organic compound (VOC) through the plurality of graphene-based sensors (since the sample air flow outlet of the mouthpiece is configured to be coupled to a VOC sensor device inlet as described in ¶¶s 0048, 0049, etc.), wherein the check valve is operable to prevent backflow of the air flow to the user from either or both the body conduit of the mouthpiece and a cassette conduit of the cassette (Fig. 4, one-way valve 28, ¶ 0045)(note that the cassette and biosensor limitations do not actually limit the claimed mouthpiece).
Regarding claim 10, Ahmad discloses all the features with respect to claim 1, as outlined above. Ahmad further discloses wherein the mouthpiece is disposable (¶ 0044, detachable).
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.
Claim 5 is are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0099109 (“Ahmad”) in view of US Patent Application Publication 2020/0305850 (“El-Fahmawi”).
Regarding claim 5, Ahmad teaches all the features with respect to claim 4, as outlined above. Ahmad does not appear to explicitly teach wherein the filter is a size selective filter.
El-Fahmawi teaches a filter associated with a mouthpiece being interchangeable to select for debris type and size (¶ 0041).
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 filter of Ahmad size selectable as in El-Fahmawi (i.e., filtering a particular particle size), for the purpose of being able to target specific types and sizes of debris (El-Fahmawi: ¶ 0041).
Claims 6 and 7 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0099109 (“Ahmad”) in view of US Patent Application Publication 2019/0299055 (“Poulsen”).
Regarding claims 6 and 7, Ahmad teaches all the features with respect to claim 1, as outlined above. If Ahmad does not explicitly teach wherein the sample air flow outlet is configured to be coupled to a cassette inlet of a cassette comprising a biosensor including a plurality of graphene-based sensors and the biosensor is operable to detect at least one volatile organic compound (VOC) through the plurality of graphene-based sensors (although the mouthpiece is coupled to a VOC sensor device as described in ¶¶s 0048, 0049, etc.), it does teach wherein the check valve is operable to prevent backflow of the air flow to the user from either or both the body conduit of the mouthpiece and a cassette conduit of the cassette (Fig. 4, one-way valve 28, ¶ 0045)(note that the cassette and biosensor limitations do not actually limit the claimed mouthpiece).
Poulsen teaches a mouthpiece outlet being removably connectable to a cassette inlet to allow for cleaning of the mouthpiece (¶¶s 0028, 0104).
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 consider the sensor device of Ahmad a cassette, with an inlet coupled to the outlet of the mouthpiece, as already contemplated (Ahmad: ¶ 0048), since Poulsen teaches that the sensor unit which houses all the electronic parts can be considered a cassette. It would have been obvious to make the sample outlet of the mouthpiece coupleable to a cassette inlet, as in Poulsen, for the purpose of being able to easily disconnect and clean the mouthpiece (Poulsen: ¶ 0028).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0099109 (“Ahmad”) in view of US Patent Application Publication 2009/0187113 (“Friedman”).
Regarding claim 8, Ahmad teaches all the features with respect to claim 1, as outlined above. Ahmad does not appear to explicitly teach wherein the check valve is an umbrella check valve.
Friedman teaches using an umbrella check valve in a breath collection device (¶ 0061).
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 an umbrella check valve for the valve of Ahmad, as in Friedman, as a simple substitution with predictable results (preventing backflow), and for the purpose of obtaining a tight seal (Friedman: ¶ 0061).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0099109 (“Ahmad”) in view of US Patent Application Publication 2004/0260194 (“Bayer”).
Regarding claim 9, Ahmad teaches all the features with respect to claim 1, as outlined above. Ahmad does not appear to explicitly teach a mouthguard operable to prevent the user from overshooting the mouthpiece.
Bayer teaches a mouthpiece having a mouthguard to prevent the user from overshooting the mouthpiece (Figs. 6-8, stop 84, ¶ 0039).
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 mouthguard into the mouthpiece of Ahmad, as in Bayer, for the purpose of limiting the amount of mouthpiece that may be inserted into the mouth (Bayer: ¶ 0039).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0099109 (“Ahmad”) in view of US Patent Application Publication 2010/0242960 (“Zangerle”).
Regarding claim 11, Ahmad teaches all the features with respect to claim 1, as outlined above. Ahmad does not appear to explicitly teach wherein the body comprises a first housing and a second housing, and wherein the first housing snap fits to the second housing to form the body.
Zangerle teaches making a mouthpiece body of two halves (¶ 0121). In a separate section, Zangerle teaches connecting two housing halves via a snap fit connection (¶¶s 0016, 0019, 0020, 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 make the mouthpiece of two halves in Ahmad as in Zangerle, and to connect the mouthpiece halves via a snap fit connection, as in Zangerle, for the purpose of allowing the components to be joined and released for cleaning (Zangerle: ¶ 0178), the snap fit mechanism known for being releasable (Zangerle: ¶ 0019).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0099109 (“Ahmad”) in view of US Patent Application Publication 2004/0260194 (“Bayer”) and US Patent Application Publication 2014/0358019 (“Johnson”).
Regarding claim 12, Ahmad teaches all the features with respect to claim 1, as outlined above. Ahmad does not appear to explicitly teach wherein the body conduit further comprises an exhaust.
Bayer teaches a mouthpiece having an exhaust for discharging discarded breath (Figs. 7 and 8, discard breath port 110, ¶ 0041).
Johnson teaches discarding an undesirable portion of the breath sample (¶ 0051, air from the dead space – also see Fig. 2, ¶¶s 0051, 0052, 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 incorporate an exhaust into the mouthpiece of Ahmad as in Bayer, for the purpose of exhausting dead space gas to analyze only a relevant portion of the exhalation (Johnson: ¶¶s 0049, 0051, etc.).
Regarding claim 13, Ahmad-Bayer-Johnson teaches all the features with respect to claim 12, as outlined above. Ahmad-Bayer-Johnson further teaches wherein 80% to 95% of the air flow from the breath entering the breath inlet exits through the exhaust and any remaining air flow is the air flow sample (Johnson: ¶ 0051, e.g. 10% of the exhaled breath is analyzed. The particular amount to analyze and/or discard is a known results-effective variable because it can be changed as desired to obtain the relevant portion of the exhalation (Johnson: ¶¶s 0051, 0052, etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exhaust e.g. 80% to 95% of the air flow in the combination as in Johnson, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,460,466 (“the reference patent”) in view of Bayer, Zangerle, Friedman, Johnson, Poulsen, Ahmad, and/or El-Fahmawi. The reference patent teaches all features except for those made up by Bayer, Zangerle, Friedman, Johnson, Poulsen, Ahmad, and/or El-Fahmawi as outlined above.
Conclusion
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