DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on August 6, 2026 were received and fully considered. Claims 71-74, 81-83, 87, and 88 were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Claim Rejections - 35 USC § 102(A)(1 & 2)
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 (i.e., changing from AIA to pre-AIA ) 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.
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 71, 73, 77, 84-86, 88, and 89 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Kofoed et al. (US Patent No. 5789660) (hereinafter “Kofoed”).
With respect to claim 71, Kofoed teaches a measuring device for analyzing a respiratory gas flow (abstract “integrated airway adapter capable of monitoring CO2 concentration… and monitoring respiratory flow with differential pressure flowmeters”), wherein the measuring device comprises at least one measuring unit (Figs. 1 and 4 shows CO2 monitoring portion 28 and flow monitoring device 30); and a cuvette (adaptor 20 in Fig. 1) releasably connected to the measuring unit and adapted and configured for a respiratory gas to flow through it (cuvette 20 is releasably connected to the breathing circuit and gas flows through flow passage 34; see Fig. 1), and wherein the measuring unit comprises at least two sensor units, a first sensor unit of the at least two sensor units being configured to determine a respiratory gas flow and a second sensor unit of the at least two sensor units being configured to determine a CO2 concentration in a respiratory gas (flow monitoring device 30 and IR CO2 transducer 22 are separate functional sensing components used with the same airway adapter; Fig. 1), and the cuvette comprises at least two sensor connectors, a first sensor connector of the at least two sensor connectors being configured for attaching the first sensor unit to the cuvette and a second sensor connector of the at least two sensor connectors being configured for attaching the second sensor unit to the cuvette (the two pressure ports/male stems 70/72 provide the connection point, via tubing, for attaching the differential pressure flow transducer to the airway adapter, which equates to the first sensor connector; the U-shaped seat/casing element 36 with its associated windows 40/42, which provides the detachable snap-fit mounting point for the CO2 sensor equates to the second sensor connector).
With respect to claim 73, Kofoed teaches wherein the second sensor unit configured to determine the CO2 concentration in the respiratory gas comprises at least one radiation source, at least one detector unit, at least one mirror, at least two lenses and at least one prism (Abstract; Fig. 1).
With respect to claim 77, Kofoed teaches wherein the radiation source is an infrared radiation source (abstract).
With respect to claim 84, Kofoed teaches wherein the cuvette comprises a coupling for a gas-conveying connection to a patient interface (Fig. 1).
With respect to claim 85, Kofoed teaches wherein the cuvette and the measuring unit are releasably connected to one another by at least one connecting element of the measuring unit and at least one connecting element of the cuvette (Fig. 1).
With respect to claim 86, Kofoed teaches wherein the at least two sensor units of the measuring unit are arranged together in a housing (Fig. 1).
With respect to claim 88, Kofoed teaches wherein the third sensor unit comprises at least one sensor head (Fig. 1).
With respect to claim 89, Kofoed teaches wherein the third sensor unit comprises at least one sensor head (Fig. 1).
Claims 71, 72, and 84-88 are rejected under 35 U.S.C. 102(A)(2) as being anticipated by Schranz et al. (US PG Pub. No. 2023/0233781 A1) (hereinafter “Schranz”).
Schranz was applied in the previous office action.
With respect to claim 71, Schranz teaches a measuring device for analyzing a respiratory gas flow (abstract “evaluation device for processing sensor signals… representing… gas flowing in the ventilation conducting assembly”), wherein the measuring device comprises at least one measuring unit (Fig. 1 shows sensor assemblies 54, 55, and 48; see also par.0088) and a cuvette releasably connected to the measuring unit and adapted and configured for a respiratory gas to flow through it (Fig. 1 shows measuring cuvette 52 is detachably coupled with sensors 54, 55, and 48; see also par.0094), and wherein the measuring unit comprises at least two sensor units (par.0088 “sensor assemblies 54, 55, and also 48”; see also Fig. 1), a first sensor unit of the at least two sensor units being configured to determine a respiratory gas flow and a second sensor unit of the at least two sensor units being configured to determine a CO2 concentration in a respiratory gas (par.0094 “flow sensor 48… CO.sub.2 sensor assembly 54”), and the cuvette comprises at least two sensor connectors, a first sensor connector of the at least two sensor connectors being configured for attaching the first sensor unit to the cuvette and a second sensor connector of the at least two sensor connectors being configured for attaching the second sensor unit to the cuvette (cuvette 52 has multiple ports/connectors for attaching to flow sensor 48 and CO2 sensor 54; see Fig. 1).
With respect to claim 72, Schranz teaches wherein the cuvette comprises at least three sensor connectors, at third sensor connector of the at least three sensor connectors being configured for attaching a third sensor unit for determining a respiratory gas pressure (Fig. 1; par.0093+ “differential pressure flow sensor”).
With respect to claim 84, Schranz teaches wherein the cuvette comprises a coupling for a gas-conveying connection to a patient interface (Fig. 1 shows cuvette 52 is coupled to various components, including control device 14).
With respect to claim 85, Schranz teaches wherein the cuvette and the measuring unit are releasably connected to one another by at least one connecting element of the measuring unit and at least one connecting element of the cuvette (par.0094 “coupled detachably with the measuring cuvette”; see also Fig. 1).
With respect to claim 86, Schranz teaches wherein the at least two sensor units of the measuring unit are arranged together in a housing (Fig. 1).
With respect to claim 87, Schranz teaches wherein the third sensor unit for determining the respiratory gas pressure determines the respiratory gas pressure via a difference from atmospheric pressure (par.0093).
With respect to claim 88, Schranz teaches wherein the third sensor unit comprises at least one sensor head (Fig. 1).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 73-77, 79-81, 84, and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Schranz in view of Wilke et al. (US Patent No. 6039697) (hereinafter “Wilke”).
Wilke was applied in the previous office action.
With respect to claim 73, Schranz teaches wherein the second sensor unit configured to determine the CO2 concentration in the respiratory gas comprises at least one radiation source, at least one detector unit (par.0094 “infrared gas sensor… CO.sub.2 sensor assembly”; par.0096 “infrared light through the measuring cuvette”).
However, Schranz does not teach at least one mirror, at least two lenses and at least one prism.
Wilke teaches an infrared respiratory gas analyzer (title) that can at least one mirror, at least two lenses and at least one prism (see col. 7 lines 56-62).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Schranz to incorporate at least one mirror, at least two lenses and at least one prism., in order to control or direct the infrared light, as evidence by Wilke (see col. 7 lines 56-62). Furthermore, PHOSITA would have had predictable success combining Schranz and Wilke as both teachings relate to the same narrow field of endeavor, i.e. utilizing infrared to analyze respiratory gas.
With respect to claim 74, Wilke teaches wherein the second sensor unit configured to determine the CO2 concentration in the respiratory gas comprises at least two prisms, at least one of the at least two lenses being arranged on each prism (see col. 7 lines 56-62). Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Schranz to incorporate at least two prisms and at least two lenses, in the matter recited, in order to control or direct the infrared light, as evidence by Wilke (see col. 7 lines 56-62). Furthermore, PHOSITA would have had predictable success combining Schranz and Wilke as both teachings relate to the same narrow field of endeavor, i.e. utilizing infrared to analyze respiratory gas.
With respect to claim 75, Schranz and Wilke do not teach wherein the at least one mirror is a concave mirror which is coated for high reflection of radiation in a wavelength range of from 3500 nm to 4600 nm. However, further modification to incorporate this feature would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art (Note: Schranz and Wilke teach infrared radiation, which inherently uses a wavelength range), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 76, Schranz and Wilke do not explicitly teach wherein the at least one detector unit comprises at least two detector faces, at least one of the two detector faces being configured for detecting wavelengths in a wavelength range from 3950 nm to 4550 nm, and at least one of the at least two detector faces being configured for detecting wavelengths in a wavelength range from 3600 nm to 4200 nm, and/or at least one of the at least two detector faces being configured as measuring detector and at least one of the at least two detector faces being configured as comparison detector, the at least two detector faces having the same size and the detector face configured for detecting wavelengths in a wavelength range from 3950 nm to 4550 nm being configured as a measuring detector. However, further modification to incorporate this feature would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art (Note: Schranz and Wilke teach infrared radiation, which inherently uses a wavelength range), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 77, Schranz teaches wherein the radiation source is an infrared radiation source (par.0096).
With respect to claim 79, Schranz in view of Wilke render obvious wherein the cuvette is arranged between one of the at least two lenses and the at least one prism (see Wilke, col. 7 lines 56-62). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Schranz to the at least two lenses and the at least one prism, in the matter recited, in order to control or direct the infrared light, as evidence by Wilke (see col. 7 lines 56-62). Furthermore, PHOSITA would have had predictable success combining Schranz and Wilke as both teachings relate to the same narrow field of endeavor, i.e. utilizing infrared to analyze respiratory gas.
With respect to claim 80, Schranz and Wilke do not explicitly teach wherein a total transmission of optics consisting of mirror, radiation source, lenses and prisms of the second sensor unit as well as the cuvette is more than 50 %. However, further modification to incorporate this feature would have been prima facie obvious to PHOSITA when the invention was filed 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 involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 81, Schranz and Wilke do not explicitly teach wherein at least one prism, the lenses and the cuvette are made of a plastic, the plastic exhibiting a transmission of infrared rays at a material thickness of 2 mm of more than 85 %. However, further modification to incorporate this feature would have been prima facie obvious to PHOSITA when the invention was filed 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 involves only routine skill in the art. In re Aller, 105 USPQ 233. Moreover, utilizing plastic, as the material for cuvette, prisms, lenses, etc. would have been obvious to PHOSITA as a design choice. See also below for example teaching, which sets forth that it is known to utilize plastics as material for cuvette (Raemer).
With respect to claim 84, Schranz and Wilke suggest wherein a surface of one of the prisms together with a surface of a second prism forms a tapering gap, the cuvette having an outer cross-section which fits the tapering gap in the area of a sensor connector for attaching the sensor unit for detecting the concentration of C02 (Schranz’s Fig. 1 depicts that cuvette 52, modified by Wilke, would be tapered for attaching to sensors 54, 55, and 48)
With respect to claim 89, Schranz and Wilke do not teach wherein the measuring device, consisting of the measuring unit and the cuvette, has an overall weight of less than 120 g. However, further modification to incorporate this feature would have been prima facie obvious to PHOSITA when the invention was filed 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 involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Schranz and Wilke, as applied to claim 73 above, in further view of Sinclair et al. (US PG Pub. No. 2014/0153864 A1) (hereinafter “Sinclair”).
Sinclair was applied in the previous office action.
With respect to claim 78, Schranz and Wilke teach a measuring device for analyzing a respiratory gas flow. Wilke also teaches utilizing a prism (see rejection of claim 73).
However, Wilke does not explicitly teach an inverting prism.
Sinclair teaches an inverting prism (par.0073 “roof prism”; Note: instant application discloses inverting prism, preferably as a roof prism, see par.18).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Wilke to utilize an inverting/roof prism as a roof prism is relatively easy to manufacture and creates an axicon effect extending the depth of field, as evidence by Sinclair (par.0073).
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Schranz and Wilke, as applied to claim 73 above, in further view of Raemer (US Patent No. 4648396).
Raemer was applied in the previous office action.
With respect to claim 82, Schranz and Wilke teach a measuring device for analyzing a respiratory gas flow.
However, Schranz and Wilke do not teach the limitations further recited in claim 82.
Raemer teaches wherein the plastic consists of more than 90 % by weight of a polysulfone, a polyethersulfone, a polymethylmethacrylate, a polycarbonate, a polytetrafluoroethylene, a poly(arylenesulfone), a polyimide, a polyamide and/or a mixture of at least one of the listed polymers and optionally a further polymer (col. 5 line 68 – col. 6 line 3).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Schranz’s cuvette 52 to be made of plastic, such as polycarbonate, in order to allow for transparency with respect to infrared radiation, as evidence by Raemer (col. 5 line 68 – col. 6 line 3). Although Raemer does not explicitly teach more than 90% weight of polycarbonate, further modification to utilize more than 90% of the recited material(s) would be obvious as a mere design choice.
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 112B rejections raised in the previous office action were persuasive in view of amendment. Therefore, these rejections are withdrawn.
Applicant's arguments filed with respect to the anticipation rejections raised in the previous office action have been fully considered, but they are not persuasive. Applicant first argues that Schranz is not a valid prior art reference under 35 USC 102(a)(1), as set forth in the previous office action. However, these arguments are moot in view of amendment, of which Examiner now applies Schranz under 35 USC 102(a)(2). Applicant also argues that Schranz does not disclose a cuvette having a sensor connector for attaching the flow sensor unit. Specifically, applicant contends that Schranz’s “flow sensor 48 is a separate component located upstream of the measuring cuvette 52, immediately adjacent the Y-connector 34… communicates pressure to the control device through a separate line arrangement 50 and is not attached to the cuvette 52… no connector for attaching a flow sensor to the cuvette” (Remarks, pg. 9). Examiner respectfully disagrees for the following reasons. First, and as can be seen from Schranz’s Fig. 1, the right side of flow sensor 48 touches/connects to cuvette 52; and both of these units are part of the same overall system. Moreover, the claims do not require that the flow sensor be fluidly connected to the cuvette. Absence of further structural specificity as to the connection between flow sensor and cuvette, Examiner maintains that Schranz’s assembly reads on the claimed invention when considering broadest reasonably interpretation of “a second sensor connector… configured for attaching the second sensor unit to the cuvette”. For purposes of compact prosecution, Examiner also provides an additional anticipation rejection (35 USC 102A1 via Kofoed) that also adopts applicant’s more narrowed reading of the claim, i.e. a flow sensor that is fluidly connected to cuvette. Please see prior art section above for more detail, updated citations, etc.
Conclusion
No claim is allowed.
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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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