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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`wwwusptogov
`
`
`
`
`
`14/004,542
`
`09/11/2013
`
`Hideshi Miki
`
`2013—1124A
`
`7986
`
`52349
`7590
`01”“2016
`WENDEROTH,LND&pONACK LL12. —
`1030 15th Street, NW.
`ABRAHAM, ANNIE G
`Suite 400 East
`
`Washington, DC 20005- 1503
`
`ART UNIT
`3735
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`01/11/2016
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`ddalecki @wenderoth.c0m
`e0a@ wenderoth.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 14/004,542 MIKI ET AL.
`
`
`AIA (First Inventor to File)
`Art Unit
`Examiner
`Office Action Summary
`
`
`StatusNo ANNIE ABRAHAM 3735
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136( a).
`after SIX () MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1 .704(b).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`1)IZI Responsive to communication(s) filed on 09/11/2013.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|ZI This action is non-final.
`2a)|:l This action is FINAL.
`3)|:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`; the restriction requirement and election have been incorporated into this action.
`
`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`
`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)IZI Claim(s) 8-_16 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6)|:I Claim(s)
`7)|Z| CIaim(s)_8-16is/are rejected.
`
`8)|:I Claim(s)_ is/are objected to.
`* If any)claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`
`
`()
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`are subject to restriction and/or election requirement.
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`participating intellectual property office for the corresponding application. For more information, please see
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`:/'I’\WIIW.LIsnto. ovI’ atentS/init events/
`iindex.‘s orsend an inquiry to PPI-iieedback{®usgtc.00v.
`
`hit
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 09/11/2013 is/are: a)IXI accepted or b)|:l objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`
`12)IXI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)IZl All
`
`b)|:l Some” c)I:l None of the:
`
`1.IXI Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`3.|:| Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`3) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) E InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20151208
`
`

`

`Application/Control Number: 14/004,542
`
`Page 2
`
`Art Unit: 3735
`
`DETAILED ACTION
`
`Notice of Pre-AIA or AIA Status
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`Specification
`
`1.
`
`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.
`
`2.
`
`Claim 1
`
`is objected to because of the following informalities:
`
`Claim Objections
`
`0 Claim 1 recites the limitation “out of the first period and a second period that
`
`follows the first period” which should be replaced with “where a second period
`
`follows the first period” in order to convey the correct meaning.
`
`Appropriate correction is required.
`
`Claim Rejections - 35 USC § 1 12
`
`3.
`
`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.
`
`

`

`Application/Control Number: 14/004,542
`
`Page 3
`
`Art Unit: 3735
`
`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.
`
`4.
`
`Claims 8, 11-16 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.
`
`. Claim 8 recites the limitation "NO removal unit” in line 6, and it is unclear what
`
`the acronym ‘NO’ is referring to. Therefore the scope of the claim is indefinite.
`
`For examination purposes it is assumed that NO refers to nitrogen oxide.
`
`. Claims 11-13 are rejected as they are rejected as they are dependent on claim 8.
`
`0 Claim 14 recites the limitation “the specific wavelength includes a first
`
`wavelength and a second wavelength”. It is unclear whether the specific
`
`wavelength is determined based on the first wavelength and the second
`
`wavelength or is a combination of first and second wavelengths. Therefore the
`
`scope of the claim is indefinite.
`
`0 Claim 15 recites the limitation “the period” in line 3, and there is insufficient
`
`antecedent basis of this limitation.
`
`

`

`Application/Control Number: 14/004,542
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`Page 4
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`Art Unit: 3735
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`Claim 15 recites the limitation “controls so that the external air” in line 5. It is
`
`unclear whether the control is on the flow of the air or on deciding which period
`
`the flow is directed to or on the switching component that closes and opens the
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`flow path in the first and second period. Therefore the scope of the claim is
`
`indefinite.
`
`Claim 16 recites the limitation “the period” in line 13, and there is insufficient
`
`antecedent basis of this limitation.
`
`Claim 16 recites the limitation “the external air-use NO removal component" in
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`line 12, and has insufficient antecedent basis. For examination purposes claim
`
`16 is assumed to be dependent on claimf 5.
`
`Claim Rejections - 35 USC § 103
`
`5.
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for
`
`all obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described
`as set forth in section 102 of this title, if the differences between the subject matter sought to
`be patented and the prior art are such that the subject matter as a whole would have been
`obvious at the time the invention was made to a person having ordinary skill in the art to which
`said subject matter pertains. Patentability shall not be negatived by the manner in which the
`invention was made.
`
`6.
`
`Claims 8-12 are rejected under pre-AIA 35 U.S.C.103 (a) as being unpatentable
`
`over ltagaki et al. (WO2010061536 A1) in view of Kishkovich et al. (US 6207460 Bf).
`
`

`

`Application/Control Number: 14/004,542
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`Page 5
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`Art Unit: 3735
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`7.
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`Regarding claim 8, Itagaki discloses a nitrogen oxide concentration measurement
`
`device (paragraph 0018), comprising: a detecting element containing a metal complex
`
`of porphyrin or a derivative thereof (paragraph 0032 discloses a sensing element
`
`containing porphyrin with cobalt as a central metal);
`
`a mouthpiece for taking in exhaled air (0048 discloses a gas inlet which is considered
`
`as the mouth piece because the exhaled air is introduced through the gas inlet.
`
`Paragraph 0003-0006 teaches a system for analysis of N0 gas in exhaled air);
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`a chamber for housing the detecting element (paragraph 0048 discloses a
`
`measurement cell in which the sensing element is set);
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`a gas flow path that communicates with the mouthpiece and the chamber(paragraph
`
`0048 discloses that the gas is introduced from the gas inlet to the measurement cell
`
`which implies that there is a gas flow path between the two);
`
`a light source that shines light on the detecting element (paragraph 0032 discloses that
`
`the sensing element is irradiated with light);
`
`a voltage value output component that outputs, a voltage value indicating the amount of
`
`light having a specific wavelength out of all the light emitted from the detecting element
`
`(paragraph 0038 discloses the light from the sensing element is detected as the output
`
`voltage. Paragraph 0057 discloses specific wavelength of the light that is emitted from
`
`the sensing element which is porphyrin with cobalt; paragraphs 0085-0086 teaches
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`obtaining voltage indicating the light from sensing element);
`
`

`

`Application/Control Number: 14/004,542
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`Page 6
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`Art Unit: 3735
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`and controller that acquires the concentration of NO contained in the exhaled air on the
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`basis of the voltage value outputted from the voltage value output component
`
`(paragraph 0038 discloses that the concentration of nitrogen oxide is determined using
`
`the output voltages corresponding to the light from the sensing element when the
`
`measurement gas is brought into contact with sensing element and when the
`
`measurement gas is not brought into contact with sensing element. Paragraph 0050
`
`discloses a light detecting section 17 which is considered as the controller)
`
`ltagaki is silent regarding a NO removal unit that is disposed within the gas flow path,
`
`and that subjects exhaled air flowing through the gas flow path from the mouthpiece
`
`toward the chamber to a NO removal treatment in a first period, out of the first period
`
`and a second period that follows the first period, and regarding the usage of the voltage
`
`value outputted from the voltage value output component in the first period as a
`
`reference voltage towards the voltage output in the second period in the determination
`
`of nitrogen oxide concentration.
`
`However, Kishkovich teaches a scrubber system (120 in Figure 8A) which removes
`
`NO from the gas that is directed from the mouthpiece to the detector (Column 8, lines
`
`50-54 teaches that the scrubbing involves removal of nitrogen compounds, and nitrogen
`
`oxide is a compound of nitrogen. This gas produces reference samples.). In Figure 8A,
`
`the gas flow through the scrubbing system (A) is the first period and the gas flow
`
`through the path without the scrubbing system (B) is the second period. Kishkovich
`
`does not teach that the device is used for analysis of ‘exhaled air’ but the teachings
`
`

`

`Application/Control Number: 14/004,542
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`Page 7
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`Art Unit: 3735
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`above meets the claim limitations in terms of structure, and the use for exhaled air is
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`just an intended use.
`
`Therefore, it would have been obvious to one of ordinary skill in the art, at the time the
`
`invention was made, to modify ltagaki by introducing a scrubbing system to produce a
`
`reference gas as taught by Kishkovich, to produce a reference output voltage from the
`
`gas as taught ltagaki.
`
`ltagaki uses the output voltages corresponding to the light from the sensing element
`
`when the measurement gas is brought into contact with sensing element and when the
`
`measurement gas is not brought into contact with sensing element (paragraph 0038).
`
`The output voltage corresponding to the light from the sensing element when the
`
`measurement gas is not brought into contact with sensing element can be considered
`
`as a reference voltage. Introducing a scrubber to produce reference voltage is mere
`
`substitution of one method for another which yields predictable results.
`
`Also, ltagaki discloses determining calibration curve with known gas concentrations in
`
`paragraphs 0093-0096. Kishkovich discloses establishing a calibration curve, but states
`
`that the instrument is sensitive to loss of calibration, and the curve must be shifted
`
`relative to the true zero reading as it varies over time. The zero calibration is typically
`
`performed on the order of once a month to assure fidelity of the zero reading, or more
`
`preferably, the system performs two calibrations each cycle, where the inclusion of the
`
`scrubbers allows provision of zero air for such calibration (Column 6, lines 33-63 of
`
`Kishkovich). The combination of Kishkovich with ltagaki would have additionally or
`
`alternatively been obvious to one of ordinary skill in the art at the time of invention in
`
`

`

`Application/Control Number: 14/004,542
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`Page 8
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`Art Unit: 3735
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`order to allow the zero calibration to be performed more readily in the system of ltagaki,
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`thereby improving the accuracy of the system.
`
`8.
`
`Regarding claim 9, ltagaki as modified, as applied to claim 1 above, discloses a
`
`first flow path that houses the scrubber (In Figure 8A, the gas flow through the
`
`scrubbing system (A) is the first flow path which is the first period), second flow path (In
`
`Figure 8A, the gas flow through the path without the scrubbing system (B) is considered
`
`the second flow path which is the second period).
`
`While ltagaki alone does not disclose that the second flow path is linked to both ends
`
`of the first flow path, and a first flow path switching component that is disposed at the
`
`branch point of the first flow path and the second flow path, and the first flow path
`
`switching component closes the second flow path in the first period, and closes the first
`
`flow path in the second period, the combination with Kishkovich to allow for zero
`
`calibration gas to be provided to the sensor would necessarily incorporate the flow
`
`paths of Kishkovich as well. Kishkovich teaches that the second flow path is linked to
`
`both ends of the first flow path (Figure 8A), and multi-way valve (123 in Figure 8A,
`
`which is considered as a switching component) disposed at the branch point of the first
`
`flow path and the second flow path that directs the flow of gas to the two paths. It is
`
`recognized that Kishkovich is not explicit about how multi-way valve 123 works, but
`
`it is
`
`implied that the valve closes one path when the other is open since it is at the branch
`
`point of two paths, and it is meant to direct flow into the paths (Column 9, lines 19-22).
`
`In the case where Kishkovich does not necessarily require the closure of one path, the
`
`

`

`Application/Control Number: 14/004,542
`
`Page 9
`
`Art Unit: 3735
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`examiner recognizes that Kishkovich discloses that one sample is distributed between
`
`the two flow paths by multi-way valve 123, which leaves only two possibilities: (1) a first
`
`part of the sample is transmitted through one pathway, requiring that the other pathway
`
`be closed and then the other part of the sample is transmitted through the other
`
`pathway, requiring that the one pathway be closed; or (2) the sample parts are
`
`transmitted through the pathways simultaneously. As the transmission of samples
`
`through the pathway must occur in one of these two ways and that there are only a finite
`
`number of possibilities, one of ordinary skill in the art would have reasonably found
`
`option (1) enumerated above to have been obvious to try with a reasonable expectation
`
`of success and predictable results. Additionally, or alternatively, the use of option (1)
`
`would have been obvious as a matter of design choice.
`
`In order for calibration to occur
`
`and sensing to occur, valve 122 would have to allow only one sample through the line to
`
`the detector 126 at a time (see fig. 8a). Since valve 122 connects only one of pathway
`
`A and B with pathway 116 at a time, it does not appear that the decision to allow the
`
`samples to transmit from valve 123 to paths A and B simultaneously or one at a time
`
`would substantially effect the function of the device to allow for zero calibration. The
`
`applicant has not disclosed that the alternation in closing pathways provides a specific
`
`advantage over the prior art, is used for a particular purpose, or solves a stated
`
`problem. One of ordinary skill in the art, furthermore, would have expected the system
`
`to perform equally well with allowing simultaneous transmission of samples through the
`
`two pathways for the reasons set forth above. Accordingly the use of the alternation of
`
`

`

`Application/Control Number: 14/004,542
`
`Page 10
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`Art Unit: 3735
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`closing pathways, as claimed, is deemed to be a design consideration that fails to
`
`patentably distinguish over the prior art.
`
`9.
`
`Regarding claim 10, Itagaki as modified, as applied to claim 9 above, does not
`
`disclose a second flow path switching component that is disposed at the merge point of
`
`the first flow path and the second flow path, and the second flow path switching
`
`component closes the second flow path in the first period, and closes the first flow path
`
`in the second period.
`
`However, Kishkovich teaches a valve (122 in Figure 8A, which is considered as a
`
`switching component) disposed at the merge point of the first flow path and the second
`
`flow path. The valve is a multi-way valve and both the flow paths directs the gas to the
`
`valve (column 9, lines 12-15 teaches that gas from each flow path is directed separately
`
`via multi-way valve to the detector), and it is implied that the valve closes one path
`
`when the other open because the gas from two flow paths are directed separately
`
`through the valve.
`
`Therefore, it would have been obvious to one of ordinary skill in the art, at the time the
`
`invention was made, to further modify Itagaki by introducing a valve at the merge point
`
`of the first flow path and the second flow path as a design consideration that fails to
`
`patentably distinguish over the prior art as in claim 9 rejection above.
`
`

`

`Application/Control Number: 14/004,542
`
`Page 11
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`Art Unit: 3735
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`10.
`
`Claims 11 and 12 are rejected under pre-AlA 35 U.S.C.103 (a) as being
`
`unpatentable over Itagaki et al. (W02010061536 A1) in view of Kishkovich et al. (US
`
`6207460 B1), in View of Cinbis et al. (US 20080208020 A1 ).
`
`11.
`
`Regarding claim 11, Itagaki as modified, as applied to claim 8 above, does not
`
`disclose the NO removal treatment in a third period that follows the second period, the
`
`voltage value output component outputs a voltage value indicating the amount of light
`
`having a specific wavelength out of all the light emitted from the detecting element, in
`
`the third period following the first and second periods, and the controller acquires first,
`
`second, and third voltage values outputted from the voltage value output component in
`
`the first, second, and third periods, and acquires the concentration of NO contained in
`
`the exhaled air according to a fourth voltage value produced by correcting the second
`
`voltage value on the basis of the first and third voltage values.
`
`However, Cinbis teaches a device that corrects the light measurement using light
`
`measurement prior to and subsequent to the generated light measurement (paragraph
`
`0080). In Itagaki, the voltage in the first period is followed by the voltage in the second
`
`period and there is a repetition of initialization (first period) and measurement which is
`
`second period (paragraph 0181 of Itagaki). So, during repetition there is a period that
`
`follows the second period which is initialization (similar to first period) which can be
`
`considered as the third period. Since Itagaki derives voltage from light, it would be
`
`obvious to modify Itagaki by correcting the voltage value in the second period
`
`(measurement voltage) by using the voltage values in the first and third periods
`
`(reference voltages) similar to the manner Cinbis does in the case of light
`
`

`

`Application/Control Number: 14/004,542
`
`Page 12
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`Art Unit: 3735
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`measurements in order to improve the quality of data by correction (paragraph 0066 of
`
`Cinbis). The corrected voltage obtained can be considered as the fourth voltage which
`
`represents the concentration of NO contained in the exhaled air as taught by claim
`
`rejection 8 above.
`
`12.
`
`Regarding claim 12, ltagaki as modified, as applied to claim 11 above,
`
`discloses first voltage value the voltage value outputted from the voltage value output
`
`component at the end of the first period (As in claim rejection 8, paragraph 0038 of
`
`ltagaki discloses the light from the sensing element is detected as the output voltage; In
`
`Figure 8A of Kishkovich, the gas flow through the scrubbing system (A) is the first
`
`period). The voltage value of the third period (as in claim rejection 11) is the third
`
`voltage outputted at the light detecting section 17 of ltagaki which is considered as the
`
`controller.
`
`13.
`
`Claim 13 is rejected under pre-AlA 35 U.S.C.103(a) as being unpatentable over
`
`ltagaki et al. (WO2010061536 A1) in view of Kishkovich et al. (US 6207460 B1), and
`
`further in view of Cinbis et al. (US 20080208020 A1, and further in view of Sheehan et
`
`al. (us 5357971 A).
`
`14.
`
`Regarding claim 13, ltagaki as modified, as applied to claim 11 above, does not
`
`disclose first voltage value as the average of a plurality of voltage values outputted from
`
`the voltage value output component during the first period, and the third voltage value
`
`

`

`Application/Control Number: 14/004,542
`
`Page 13
`
`Art Unit: 3735
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`as the average of a plurality of voltage values outputted from the voltage value output
`
`component during the third period.
`
`However, Sheehan teaches determining average voltage from the plurality of voltages
`
`(Column 18, lines 30-40 teaches determining average from 5 voltage samples).
`
`Therefore, it would have been obvious to further modify ltagaki by determining the
`
`average voltages during the first period and the third period, as taught by Sheehan, in
`
`order to reduce noise in the voltages (Column 18, lines 30-33).
`
`15.
`
`Regarding claim 14, ltagaki as modified, as applied to claim 11 above,
`
`discloses that the wavelength includes a first wavelength and a second wavelength that
`
`is different from the first wavelength (paragraph 0057 discloses two wavelengths, 414
`
`nm when the NO is not exposed to the sensing element and 435 nm when the NO is
`
`exposed to the sensing element) , and the voltage value output component outputs a
`
`voltage value indicating the difference between the amount of light having the first
`
`wavelength and the amount of light having the second wavelength (paragraph 0180
`
`discloses a differential output of the voltage which is the difference between the output
`
`voltages V2 and V1) .
`
`16.
`
`Claims 8, 15 and 16 are rejected under pre-AIA 35 U.S.C.103 (a) as being
`
`unpatentable over Abraham-Fuchs et al. (US 20040133116 A1) in view of ltagaki et al.
`
`(WO2010061536 A1), and further in view of Kishkovich et al. (US 6207460 B1).
`
`

`

`Application/Control Number: 14/004,542
`
`Page 14
`
`Art Unit: 3735
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`17.
`
`Regarding claim 8, Abraham-Fuchs discloses a device for the determination of
`
`nitrogen oxide in exhaled air using sensors (abstract), a mouthpiece for taking in
`
`exhaled air (paragraph 0054 and Figure 9 teaches a mouth piece; paragraph 0065
`
`teaches a gas inlet for respiratory air);
`
`a chamber for housing a detecting element (Figure 10 and paragraph 0065 teaches a
`
`gas sensor unit that houses gas sensors that determine N02 content. The gas sensors
`
`are considered as the detecting element for N02, and gas sensor unit is considered as
`
`the chamber); a gas flow path that communicates with the mouthpiece and the chamber
`
`(paragraph 0065 teaches that the respiratory gas is blown into the gas sensor which
`
`implies that there is a gas flow path between the mouthpiece and the chamber that
`
`houses the gas sensors);
`
`Abraham-Fuchs is silent regarding a detecting element containing a metal complex of
`
`porphyrin or a derivative thereof;
`
`a light source that shines light on the detecting element;
`
`a voltage value output component that outputs, a voltage value indicating the amount of
`
`light having a specific wavelength out of all the light emitted from the detecting element;
`
`and controller that acquires the concentration of NO contained in the exhaled air on the
`
`basis of the voltage value outputted from the voltage value output component;
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`a NO removal unit that is disposed within the gas flow path, and that subjects exhaled
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`air flowing through the gas flow path from the mouthpiece toward the chamber to a NO
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`removal treatment in a first period, out of the first period and a second period that
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`follows the first period, and regarding the usage of the voltage value outputted from the
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`voltage value output component in the first period as a reference voltage towards the
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`voltage output in the second period in the determination of nitrogen oxide concentration.
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`However, ltagaki teaches a detecting element containing a metal complex of porphyrin
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`or a derivative thereof (paragraph 0032 discloses a sensing element containing
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`porphyrin with cobalt as a central metal);
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`a light source that shines light on the detecting element (paragraph 0032 discloses that
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`the sensing element is irradiated with light);
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`a voltage value output component that outputs, a voltage value indicating the amount of
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`light having a specific wavelength out of all the light emitted from the detecting element
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`(paragraph 0038 discloses the light from the sensing element is detected as the output
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`voltage. Paragraph 0057 discloses specific wavelength of the light that is emitted from
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`the sensing element which is porphyrin with cobalt; paragraphs 0085-0086 teaches
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`obtaining voltage indicating the light from sensing element);
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`and controller that acquires the concentration of NO contained in the exhaled air on the
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`basis of the voltage value outputted from the voltage value output component
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`(paragraph 0038 discloses that the concentration of nitrogen oxide is determined using
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`the output voltages corresponding to the light from the sensing element when the
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`measurement gas is brought into contact with sensing element and when the
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`measurement gas is not brought into contact with sensing element. Paragraph 0050
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`discloses a light detecting section 17 which is considered as the controller).
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`Also, Kishkovich teaches a scrubber system (120 in Figure 8A) which removes NO
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`from the gas that is directed from the mouthpiece to the detector (Column 8, lines 50-54
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`teaches that the scrubbing involves removal of nitrogen compounds, and nitrogen oxide
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`is a compound of nitrogen. This gas produces reference samples.). In Figure 8A, the
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`gas flow through the scrubbing system (A) is the first period and the gas flow through
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`the path without the scrubbing system (B) is the second period. Kishkovich does not
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`teach that the device is used for analysis of ‘exhaled air’ but the teachings above meets
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`the claim limitations in terms of structure, and the use for exhaled air is just an intended
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`use.
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`Therefore, it would have been obvious to one of ordinary skill in the art, at the time the
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`invention was made, to replace the NO-NO2 converter and N02 sensor (Figure 3 in
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`Abraham-Fuchs) of Abraham-Fuchs with the metal complex sensor of ltagaki for NO
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`sensing since it is mere substitution of one NO sensor for another to yield predictable
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`results. Also it would be obvious to further modify Abraham-Fuchs by introducing a
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`scrubber system which removes NO, as taught by Kishkovich, in order allow the zero
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`calibration to be performed more readily in the system of Abraham-Fuchs modified by
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`ltagaki, thereby improving the accuracy of the system (Kishkovich discloses establishing
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`a calibration curve, but states that the instrument is sensitive to loss of calibration, and
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`the curve must be shifted relative to the true zero reading as it varies over time. The
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`zero calibration is typically performed on the order of once a month to assure fidelity of
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`the zero reading, or more preferably, the system performs two calibrations each cycle,
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`where the inclusion of the scrubbers allows provision of zero air for such calibration
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`(Column 6, lines 33-63 of Kishkovich)).
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`18.
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`Regarding claim 15, Abraham-Fuchs as modified, as applied to claim 8 above,
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`discloses an external air-use NO removal component that subjects the external air to a
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`NO removal treatment in the period in which external air is inhaled prior to the first
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`period, and the control so that the external air undergoes the NO removal treatment by
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`the external air-use NO removal component in the period in which the external air is
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`inhaled (paragraph 0055 teaches a NO scrubber that removes NO from the inhaled gas
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`and also teaches a one way valve that makes inhalation only possible through the NO
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`scrubber. The one way valve acts as a control so that the external air undergoes NO
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`treatment in the inhalation period).
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`Abraham-Fuchs as modified, as applied to claim 8 above, does not disclose that
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`controlling the NO removal treatment is performed by the NO removal component in the
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`first period out of the period in which air is exhaled, and that exhaled air that has not
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`undergone the NO removal treatment by the NO removal component is sent to the
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`chamber in the second period out of the period in which air is exhaled.
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`However, Kishkovich teaches a control system that controls the valves that direct the
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`flow of gas towards a channel with NO removal treatment and towards a channel
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`without NO removal treatment (Column 3, lines 53-55 teaches a control system that can
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`be programmed to transfer the gas between the primary channel and scrubbing
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`channel. Column 15, lines 38-41 teaches control system controlling the valve 122 at
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`merge point in Figure 8 A, and Column 15, lines 58-60 teaches control system
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`controlling the valve 140 at branch point in Figure 9. As in claim 8 rejection above, NO
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`removal is done during the first period which includes the scrubbing system and NO
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`removal is not done during the second period which does not include the scrubbing
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`system. The control system by controlling the valves in turn controls that the NO
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`removal is done in the first period and the NO removal is not done in the second
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`period). Kishkovich does not teach that the device is used for analysis of ‘exhaled air’
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`but the teachings above meets the claim limitations in terms of structure, and the use for
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`exhaled air is just an intended use.
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`It would be also obvious to further modify Abraham-Fuchs by introducing a control
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`system that control the valves so that gas undergoes NO removal treatment in the first
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`period and not in the second period, as taught by Kishkovich, in order to keep the flow
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`paths in two periods separate because the output of first period is used as reference
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`toward the measurement of NO concentration.
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`19.
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`Regarding claim 16, Abraham-Fuchs as modified, as applied to claim 8 above,
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`discloses that the gas flow path comprises a first flow path that is formed between the
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`mouthpiece and the chamber (In Figure 8A of Kishkovich, the gas flow through the
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`scrubbing system (A) is the first flow path which is the first period) and houses the NO
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`removal component (120 in Figure 8A of Kishkovich),