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 12/22/2025 (“Amendment”), which was after-final but has been entered. Claims 18, 19, 21, 23-33, and 35 are currently under consideration. The Office acknowledges the amendments to claims 18 and 32. Claims 20 and 34 remain withdrawn.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under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Because Applicant’s arguments are persuasive over the Haveri reference, this action is made NON-FINAL.
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 18, 19, 24-26, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 6,190,327 (“Isaacson”) in view of US Patent 5,261,415 (“Dussault”) and US Patent 5,625,189 (“McCaul”).
Regarding claim 18, Isaacson teaches [a] capnometer (col. 3, lines 29-39, claim 4) for detecting a concentration of a component in a gas provided by a patient (Abstract, col. 1, lines 14-35 and 59-62), said capnometer comprising: an air flow region configured to pass said gas to and/or from a lung of said patient (as shown in the Figs., e.g. the inside of adapter tube 16 in Fig. 4 - also see col. 3, lines 5-18); a mid-IR … emitter configured to provide IR light at a wavelength in a range 3-5 μm (col. 3, lines 54-67, emitter 34 and filter 36 providing light at a wavelength of 4.26 micrometers); a mid-IR … detector to detect said IR light (col. 3, lines 54-67, detector 38); a reflector to reflect said IR light emitted by said emitter (col. 3, lines 54-67, reflective surface 30 of reflector 28); a removable breath tube (Fig. 2, adapter tube 16 being removable as shown in Figs. 8-10), wherein said breath tube defines a channel between said emitter or detector and said reflector for said air flow region (Fig. 4, the channel being the space within the adapter 16 as shown); and an optical layer between said emitter and said reflector and/or between said detector and said reflector (Figs. 3 and 4, because the window 24 (an optical layer) is curved as a positive meniscus, it helps focus the emitted light onto the reflector), wherein … said emitter, said detector, and said reflector are arranged such that said IR light emitted by said emitter passes through said air flow region via said reflector to said detector (Fig. 4), and wherein said breath tube comprises a mid-IR transmissive portion, said mid-IR transmissive portion being aligned with said emitter and said detector to allow mid-IR light to pass therethrough into and out of said breath tube (col. 3, lines 40-53, optical windows 22 and 24 provided in tube 16 – also see Figs. 3 and 4, and col. 2, lines 18-20), and wherein said air flow region includes a reduction in its cross-sectional area where said IR light passes through said air flow region, the reduction sufficient to accelerate the gas through the area where said IR light passes through said air flow region (col. 4, lines 30-38, the inner diameter at end 44 being the same as the outer diameter at end 42 - also see Figs 1-3, etc. Further, col. 1, lines 36-50 incorporate by reference US Patent 5,445,160 (“Culver”), which teaches in Fig. 1 and col. 2, lines 50-62 that the broader end of the breath tube is patient facing, while the narrower end leads to a breathing device. Thus, an exhalation gas sample flows from the broader end to the narrower end. When this understanding is applied to Isaacson, it is clear that the sample is provided at end 44, and thus accelerated in the region of the IR sensor).
Isaacson does not appear to explicitly teach the emitter and detector being semiconductor emitters and detectors.
Dussault teaches semiconductor emitters and detectors used in a capnometer with the wavelength range claimed (Abstract, col. 3, lines 47-60).
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 the emitters and detectors of Dussault in Isaacson as the simple substitution of one known element for another, with predictable results (replacing the e.g. filament lamp of Isaacson with the semiconductor emitter of Dussault, each providing the same wavelength and therefore enabling the system to operate in the same way to provide the predictable result of CO2 absorption detection (Dussault: Abstract)), and for the purpose of simplifying manufacture of the components (semiconductor dies being easily replicated).
Isaacson-Dussault does not appear to explicitly teach wherein said emitter is parallel with the optical layer, and wherein said detector is parallel with the optical layer.
McCaul teaches, in a gas sensor assembly, arranging an emitter and detector parallel with an optical layer, while enabling the same functionality as in Isaacson by using a curved rather than straight reflector (Fig. 28, col. 23, lines 3-12).
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 straight/parallel emitter, detector, and optical layer arrangement in the combination, with a curved reflector, as in McCaul, instead of vice versa as in Isaacson, as a simple substitution of parts with the predictable result of guiding the emission to the detector (McCaul: Fig. 28), since the two are known alternatives (Isaacson and McCaul), and since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art when the choice of shape has no significant impact on the operation of the invention. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). It would have been obvious to use the configuration to enable multiple radiation passes, for the purpose of being able to determine the concentration of a gas having weak absorption lines (McCaul: Abstract).
Regarding claim 19, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul further teaches wherein said detection of said concentration of said component in said gas comprises detecting a temporal variation of said concentration (inherent in Isaacson - also see Dussault: Fig. 5B, capnogram).
Regarding claim 24, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul further teaches a reflector mounting for supporting said reflector (Isaacson: Fig. 4, the structure supporting reflective surface 30).
Regarding claim 25, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul further teaches a memory to store a level data output (Isaacson: col. 4, lines 52-57).
Regarding claim 26, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul further teaches wherein said component is CO2 (Isaacson: Title).
Regarding claim 35, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul further teaches wherein the reflector is mounted outside the removable breath tube (Dussault: Figs. 1, 1A, 2A, and 6 show insert 22 (which has windows 28 and 30 for letting light pass through) as forming essentially a removable breath tube, and housing 26 as surrounding the insert 22, the housing 26 having the emitter and detector on one side and the reflector (mirror 158) on an opposite side (Fig. 6), all external the insert/breath tube. 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 arrange the reflector of the combination outside of the breath tube, as in Dussualt, for the purpose of making removal/disposal of the breath tube easier (unlike Figs. 4 and 5 of Isaacson, where the reflector is positioned into the wall of the breath tube), for increasing signal to noise ratio as described with respect to Fig. 6 in Dussault, and since such a modification would be an obvious rearrangement of parts. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)).
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson-Dussault-McCaul in view of US Patent 5,650,624 (“Wong”).
Regarding claim 21, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul further teaches wherein the optical layer … is disposed on top of the emitter and the detector for improving a collection efficiency of said IR light emitted by said emitter onto said detector (Isaacson: Figs. 3 and 4, because the window 24 (an optical layer) is curved as a positive meniscus, it helps focus the emitted light onto the reflector (note the optical layer can be considered on top in at least one orientation of the device) - also see Dussault: Fig. 3, lens 76, and McCaul: Fig. 28), but does not appear to explicitly teach wherein the optical layer comprises silicon.
Wong teaches that a suitable material for windows in the particular context is silicon (col. 11, lines 11-22.
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 silicon for the window/optical layer of the combination, 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 23, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul does not appear to explicitly teach wherein said emitter is configured to provide said IR light at two or more different wavelengths in the range 3-5 μm, and wherein said detector is configured to detect said two or more different wavelengths for a signal processor (although see Isaacson: claim 8, implying that radiation is emitted at two different wavelengths (compare to claim 7)).
Wong teaches providing IR light at two or more wavelengths in the range claimed (col. 8, lines 51-57; col. 6, lines 60-61; claim 8).
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 emission and detection at multiple wavelengths in the 3-5 μm range into the combination, for the purpose of monitoring the concentration of a plurality of gases (Wong: Abstract), thereby more comprehensively evaluating the patient.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson-Dussault-McCaul in view of US Patent Application Publication 2013/0271751 (“Macgegor”).
Regarding claims 27 and 28, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul does not appear to explicitly teach wherein said emitter comprises a III-V mid-IR semiconductor emitter, wherein said detector comprises a III-V mid-IR semiconductor detector.
Macgegor teaches using III-V semiconductor materials for both the emitter and the detector of a CO2 sensor (¶¶s 0038, 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 use III-V semiconductor materials for the emitter and detector of the combination, as taught by Macgegor, 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).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Isaacson-Dussault-McCaul in view of US Patent Application Publication 2012/0019767 (“Cadet”).
Regarding claim 29, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul does not appear to explicitly teach wherein said reflector comprises a reflective metal film coated with an organic layer (although Isaacson: col. 2, lines 12-17 teach coating the surface of the reflector with an anti-fog coating, and col. 3, lines 50-53 teach that the reflector is coated with a highly reflective aluminum coating).
Cadet teaches that anti-fog coatings commonly use organic materials (¶¶s 0006, 0018, 0025-0028, 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 anti-fog coating of the combination out of organic materials, as in Cadet, 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).
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson-Dussault-McCaul in view of US Patent 8,471,208 (“Tang”).
Regarding claims 30 and 31, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul does not appear to explicitly teach wherein said emitter comprises a plurality of emitters, and wherein each of said plurality of emitters emits light centred at a different, respective wavelength, wherein said detector comprises a plurality of detectors, and wherein each of said plurality of detectors detects light at a different, respective range of wavelengths.
Tang teaches using two emitters that generate two infrared beams at different frequencies, together with two detectors that detect the infrared beams (Fig. 3, col. 1, lines 45-57).
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 multiple emitters and detectors in the combination, as in Tang, since such a modification would have involved a mere duplication of parts (a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)), and for the purpose of determining whether the gas under test is the gas being tested for (Tang: col. 1, lines 58-63).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Isaacson-Dussault-McCaul in view of US Patent Application Publication 2007/0173731 (“Meka”).
Regarding claim 32, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul does not appear to explicitly teach a diversion device for blocking one of a first and a second air-flow path in the capnometer at a time, said diversion device comprising a diverting valve which is controlled by inhalation/exhalation of said gas by said patient, wherein said first air-flow path connects an inhaling/exhaling portion of the capnometer at which said patient inhales/exhales air and an intake portion of said capnometer through which air enters said capnometer, and wherein said second air-flow path connects said inhaling/exhaling portion and an exit portion of said capnometer at which air exits said capnometer.
Meka teaches a valve system that blocks one of a first and second air-flow path at a time (Figs. 1C, 1D, 3-way breath capture valve), wherein the first air-flow path connects an inhaling/exhaling portion with an intake portion (Fig. 1D, the connection/flow path shown), wherein the second air-flow path connects the inhaling/exhaling portion with an exit portion (Fig. 1C, the connection/flow path shown). The valve system is controlled by a user’s inhalation/exhalation (¶ 0064 - also see Figs. 1C and 1D, Fig. 8 and related description, e.g. ¶ 0066).
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 such a valve system in the combination, for the purpose of enabling the user to breath in and out at the same location, thereby making the device easier to use, and for allowing the exhaled gas to be further analyzed (Meka: ¶¶s 0003, 0005, 0066, 0068).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Isaacson-Dussault-McCaul in view of US Patent Application Publication 2015/0034084 (“Av-Gay”).
Regarding claim 33, Isaacson-Dussault-McCaul teaches all the features with respect to claim 18, as outlined above. Isaacson-Dussault-McCaul does not appear to explicitly teach [a]n inhaler comprising: the capnometer, wherein said capnometer is configured to monitor a CO2 level in air inhaled through or exhaled through said inhaler.
Av-Gay teaches the combination of an inhaler and a capnometer (¶¶s 0024, 0033, 0036, 0093, 0131, 0304, 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 the capnometer in an inhaler as claimed, for the purpose of enabling an alarm/warning when needed, thereby increasing patient safety (Av-Gay: ¶ 0131).
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 18, 19, 21, 23-33, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 11,986,284 (“the ‘284 patent”) in view of Isaacson, Dussault, McCaul, Wong, Macgegor, Cadet, Tang, Meka, and/or Av-Gay. All features are taught by claim 1 of the ‘284 patent except for those made up by Isaacson, Dussault, McCaul, Wong, Macgegor, Cadet, Tang, Meka, and/or Av-Gay as outlined above.
Claims 18, 19, 21, 23-33, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 12,138,036 (“the ‘036 patent”) in view of Isaacson, Dussault, McCaul, Wong, Macgegor, Cadet, Tang, Meka, and/or Av-Gay. All features are taught by claim 1 of the ‘036 patent except for those made up by Isaacson, Dussault, McCaul, Wong, Macgegor, Cadet, Tang, Meka, and/or Av-Gay as outlined above.
Response to Arguments
Applicant’s arguments filed 12/22/2025 have been fully considered. They are persuasive with respect to the Haveri reference. Therefore, a new grounds of rejection is made based on Isaacson itself (incorporating teachings of Culver), and all claims remain rejected in light of the prior art.
The double patenting rejections are not reduced to prior art rejections because the base teachings are provided by the reference claims.
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791