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 .
Response to Arguments
Applicant’s arguments with respect to all pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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Claims 1 – 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 - 25 of U.S. Patent No. U.S. 11,209,417 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they seek to encompass the same invention (i.e., a flow control assembly comprising a proximal receiving channel, a main receiving channel defining tortuous flow path, a dispersion channel configured to divert a portion of the fluid sample to the main receiving channel and a majority of the sample to the one or more secondary channels for venting from the assembly and one or more sampling chambers as claimed).
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.
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.
Claim(s) 1 – 6, 10, 11, 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0358019 A1 to Johnson (hereinafter “Johnson”) in view of U.S. Patent Application Publication No. 2015/0164373 A1 to Davis et al. (hereinafter “Davis”).
Regarding Claim 1, Johnson teaches a flow control assembly (see abstract, see arrangement at Fig. 5), comprising:
a proximal receiving channel sized to receive a fluid sample (see inlet 32, Fig. 5, see paragraph [0053] describing “inlet 32 adapted to receive an inflow I of breath exhaled by a patient”);
a dispersion channel fluidly connected to the proximal receiving channel (see paragraph [0053] which states “The inlet comprises a fluid conduit which transports the exhaled breath I towards a bifurcation 39 adapted to separate a first portion I' of the exhaled breath to be analyzed, from a second portion I'' of the exhaled breath I, which is to be discarded”, thus the bifurcation 39 serving as the dispersion channel as claimed);
a main receiving channel (see buffer chamber 31, Fig. 5, paragraph [0053]), wherein the dispersion channel is configured to divert a portion of the fluid sample (see bifurcation 39 which diverts the fluid with a first portion and second portion as seen at Fig. 5) to the main receiving channel (31) and a majority of the fluid sample to one or more secondary channels for venting from the assembly (see paragraph [0053] describing “The bifurcation 39 divides the fluid conduit 39 into a first fluid conduit 34a and a second fluid conduit 34b. The second fluid conduit 34b guides the second portion I'' of the exhaled breath to be discarded”, see also paragraph [0061] describing adjustment member 70 comprising apertures 71, 72 that are used to lead a fluid flow into the first flow channel 34a and the second flow channel 34b, note that the sizes of the apertures are different hence providing a portion of fluid through the main receiving channel 31 via aperture 72 while providing majority of the fluid sample to secondary channel for discharge through 34b via larger aperture 71, hence reading on the invention as claimed); and
one or more sampling chambers (see sensor 63, Fig. 1, see paragraph [0060]) fluidly connected to the main receiving channel (31) via one or more openings (see arrangement at Fig. 5, note that it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to recognize an opening or port that allows communication of the sensor 63 with the fluid conduit 36, since the fluid conduit 36 is arranged with the sensor element 63 for fluid communication).
Even though Johnson teaches a sensor 63 connected to the main receiving channel 36 as described above, Johnson does not explicitly teach wherein the one or more sampling chambers are located along a common plane such that each of the one or more openings extend away from the common plane and into the main receiving channel.
Davis, in the field of exhaled breath analysis devices for monitoring lung functions, teaches wherein the one or more sampling chambers are located along a common plane (see at least “Chemical Sensors” arranged on common plane at “SENSOR CIRCUIT BOARD 508” in Fig. 5A) such that each of the one or more openings extend away from the common plane and into the main receiving channel (see arrangement at Figs. 1 – 5, illustrating a portable device 100, Fig. 1 or 500, Fig. 5A, having one or more sampling chambers such as the chemical sensors illustrated at Fig. 5A, and/or sensors 304-1 – 304-5, Figs. 3 – 4 which are located along a common plane as illustrated at Figs. 3 – 5 and having one or more openings (i.e., openings of each sensor that allows communication with the exhaled breath) that extends away from the common plane and into the main receiving channel i.e., the flow chamber 302, 402 and/or 504, Figs. 3, 4, 5A respectively, see also paragraphs [0042], [0049] – [0052], [0064] – [0067] and corresponding paragraphs).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use one or more sampling chambers arranged along a common plane of Davis in to Johnson, in order to provide additional chemical sensors which may be selected for their combination of high sensitivity, high selectivity, miniature size and short response time. See also additional advantages at paragraphs [0041], [0055] – [0056], [0076] of Davis).
Johnson in view of Davis as modified above further teaches wherein the main receiving channel (31 of Johnson) and/or 104, 204, 302, 502, 504, Figs. 1 – 5 of Davis) defines a tortuous flow path which forces the fluid sample into a circuitous loop around the one or more sampling chambers (see arrangement at Fig. 5 and paragraph [0053] of Johnson which states “The conduits making up the buffer chamber 31 creates an S-shaped lumen 30 in which the collected breath is buffered” and arrangement at Fig. 5 illustrating the S-shaped flow path, and/or see bent path as well as orifice plate at Fig. 4 and paragraph [0058] of Davis, see also modification of the sampling chambers above, hence reading on the invention as claimed).
Regarding Claim 2, Johnson in view of Davis as modified above teaches a housing sized to contain the flow control apparatus within (see portable device 100 comprising the physical measuring device 102, Fig. 1 as well as arrangement of the portable device 500 with housing structure that contains the flow chamber and sensors at Fig. 5 of Davis).
Regarding Claim 3, Johnson in view of Davis as modified above teaches wherein the main receiving channel is sized to receive about 20% of the fluid sample (see paragraph [0051] of Johnson describing “the separated portion 24, 23 for analysis could be as much as 90%, 80% 60% 40% or 20% or as little as 1%, 2%, 4% or 10% of the total of exhaled breath”, see also paragraph [0061] of Johnson, hence reading the invention as claimed).
Regarding Claim 4, Johnson in view of Davis as modified above teaches wherein the main receiving channel is sized to receive less than 50% of the fluid sample (see paragraph [0051] of Johnson describing “the separated portion 24, 23 for analysis could be as much as 90%, 80% 60% 40% or 20% or as little as 1%, 2%, 4% or 10% of the total of exhaled breath”, see also paragraph [0061] of Johnson, hence reading the invention as claimed).
Regarding Claim 5, Johnson in view of Davis as modified above teaches further comprising one or more sensors in fluid communication respectively with the one or more sampling chambers (see modification above, see sensor 63, Fig. 5 of Johnson and/or see arrangement of the one or more sensors at Fig. 5A of Davis, hence reading on the invention as claimed).
Regarding Claim 6, Johnson in view of Davis as modified above teaches wherein the one or more sensors comprises one or more CO sensors (see paragraph [0016] of Johnson and/or see paragraph [0055] of Davis).
Regarding Claim 10, Johnson in view of Davis as modified above teaches wherein the one or more secondary channels extend from the dispersion channel at an angle (see for instance arrangement at Fig. 5 of Johnson illustrating the buffer region 31 being at an angle from the dispersion channel 39, hence reading on the invention as claimed).
Regarding Claim 11, Johnson in view of Davis as modified above teaches wherein the main receiving channel comprises a plurality of barriers or baffles which define the tortuous flow path from the dispersion channel to the one or more sampling chambers (see buffer chamber 31, Fig. 5, paragraph [0053] of Johnson).
Regarding Claim 13, Johnson in view of Davis as modified above teaches further comprising a pump in fluid communication with the fluid sample (see pump 61, Fig. 5 and paragraph [0060] of Johnson).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Davis and further in view of U.S. Patent Application Publication No. 2001/0049477 A1 to Stone (hereinafter “Stone”).
Regarding Claim 7, Johnson in view of Davis as modified above teaches comprises one or more CO sensors (see paragraph [0016] of Johnson and/or see paragraph [0055] of Davis). Johnson in view of Davis does not explicitly teach the device further comprising at least one H2 sensor.
Stone, in the field of measurement of carbon monoxide, teaches at least one H2 sensor (see paragraph [0034], Fig. 2).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate H2 sensor of Stone into Johnson in view of Davis in order to provide a reliable sensor for assessment of carbon monoxide production rate that substantially reduces the errors associated with the H2 excretion (see paragraph [0019]).
Claims 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Davis and further in view of U.S. Patent Application Publication No. 2017/0265778 A1 to Reichlyn et al. (hereinafter “Reichlyn”).
Regarding Claim 8, Johnson in view of Davis as modified above teaches the claimed invention except for one or more seals for sealing between the one or more sampling chambers and the one or more sensors.
Reichlyn, in the field of barometric pressure sensor spirometers, teaches one or more seals (see paragraph [0074] describing channel 54 receiving seal 22, Figs. 6 – 8, 31, 32) for sealing between the one or more sampling chambers (see paragraph [0089] describing airflow pathway 44 of flow chamber 14) and the one or more sensors (sensor 12, Fig. 6, see paragraph [0055]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the seal of Reichlyn into Johnson in view of Davis in order to efficiently seal off the sensor thus improving accuracy of the system.
Regarding Claim 9, Johnson in view of Davis in view of Reichlyn as modified above teaches wherein the one or more sampling chambers further define an annular tapered surface configured to urge the one or more seals into contact against a surface of the one or more sensors (see paragraphs [0010] of Reichlyn describing tapered structures, see also paragraph [0074], Figs. 6 – 8, 31, 32 of Reichlyn showing the arrangement and note that the seal is pressure seal 22 (i.e., urged)).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Davis and further in view of U.S. Patent Application Publication No. 2003/0208133 A1 to Mault (hereinafter “Mault”).
Regarding Claim 12, Johnson in view of Davis as modified above teaches the claimed invention except for wherein the flow control assembly further comprises a water permeable membrane.
Mault, in the field of respiratory analyzer devices, teaches wherein the flow control assembly further comprises a water permeable membrane (see paragraph [0021] describing use of silica which may be used for the detection of ketone using the hand held respiratory analyzer as well as selectively permeable membranes for removing selected components while concentrating volatile organics such as ketones for further detection, see also paragraph [0025] describing fluorescent film which adsorbs ketones, and paragraph [0036] describing inserting a test strip which may be moistened with water for selective absorption of organic components of the breath, hence reading on the invention as claimed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the selective permeable membranes or silica or film of Mault in to Johnson in view of Davis, in order to improve selectivity of the detected component, hence improving overall accuracy of the system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form accompanying this office action comprising the following relevant arts:
Kilpadi et al. (U.S. 2020/0197580 A1) teaches a sampling assessment system comprising sampling chambers within a housing 140 the sampling chambers comprising sampling elements 145-147 as seen for instance at Figs. 1 - 3.
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 MARRIT EYASSU whose telephone number is (571)270-1403. The examiner can normally be reached M - F: 9:00AM - 6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Laura E. Martin can be reached at (571) 272-2160. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARRIT EYASSU/Primary Examiner, Art Unit 2855
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