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 .
Status of Claims
The amendment filed 2/2/26 is acknowledged. Claims 1-4,6-15 and 23-26 are pending. Claims 5 and 16-22 are canceled. Claims 23-26 are new. Claims 1, 6, 7, 9, 12 are amended.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 23 recites the same limitations as Claim 1 and thus fails to limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1, 2, 4, 5, 7-11, 15, 23, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards et al. (US 2008/0038207 A1 – cited by Applicant), hereinafter Edwards in view of Hojer (US 2020/0221973 A1 – cited by Applicant).
Regarding Claim 1, Edwards teaches: A device for characterizing particles of exhaled air (figure 1), the device comprising:
an inlet line directed towards an external environment, the inlet line comprising a filter for filtering particles (figure 1; element 14; paragraph 0059), the inlet line being fluidly connected to a breathing line (figure 1; element 13) that comprises an interface through which air is breathable (figure 1; element 12; paragraph 0057); and
a measurement line (figure 1; element 19) that is fluidly connected to the breathing line and that is fluidly connected to a particle measurement device (figure 1; element 20; paragraph 0064) to determine a parameter corresponding to the particles of the exhaled air (paragraph 0027) but fails to mention wherein the measurement line or the particle measurement device comprise a heater configured to keep the temperature at a preset value.
Hojer teaches wherein the measurement line or the particle measurement device comprise a heater configured to keep the temperature at a preset value (0034-0035). It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention on Edwards to include wherein the measurement line and/or the particle measurement device comprise a heater configured to keep the temperature at a preset value in order to avoid evaporation or condensation.
Regarding Claim 2, Edwards in view of Hojer teaches: The device according to claim 1, wherein the breathing line is arranged substantially parallel to the inlet line or arranged coaxially to the inlet line (Edwards - figure 1, which shows a “y” shape can be considered to be “substantially” parallel under the broadest reasonable interpretation).
Regarding Claim 4, Edwards in view of Hojer teaches: The device according to claim 1, wherein the particle measurement device comprises an air flow generator configured to create an air flow with a preset flow rate, and wherein a flow rate is in a range from 0.1 I/min to 101 I/min, from 0.1 I/min to 20 I/min, or in the range from 1 I/min to 10 I/min (Edwards - paragraph 0048; 0064).
Regarding Claim 7, Edwards in view of Hojer teaches: The device according to claim 1, wherein the measurement line or the particle measurement device comprise at least one check valve (Edwards - element 16).
Regarding Claim 8, Edwards in view of Hojer teaches: The device according to claim 1, but fails to mention wherein a diameter of the measurement line is smaller than a diameter of the inlet line or a diameter of the breathing line.
It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention on Edwards in view of Hojer to include wherein a diameter of the measurement line is smaller than a diameter of the inlet line and/or a diameter of the breathing line as it has been held that changes in size and shape, where the changes in dimensions would not perform differently than the prior art device, requires only routine skill in the art (See MPEP 2144.04).
Regarding Claim 9, Edwards in view of Hojer teach: The device according to claim 1, wherein the particle measurement device determines at least one of the following parameters of the particles of the exhaled air: particle number, particle concentration, particle diameter, particle mass, particle size distribution, particle mass distribution, particle mass concentration, or particle number concentration (Edwards - paragraph 0025; 0064).
Regarding Claim 10, Edwards in view of Hojer teaches: The device according to claim 9, wherein the particle measurement device determines a particle concentration in a range from 0 to 107 particles per liter air, in a range from 0.01 to 107 particles per liter air, in a range from 0.01 to 5*106 particles per liter air, or in a range from 0.01 to 106 particles per liter air (Edwards - figures 9A-11B).
Regarding Claim 11, Edwards in view of Hojer teaches: The device according to claim 9, wherein the particle measurement device determines particle diameters in a range from 0.1 µm to 5 µm, in a range from 0.1 µm to 1 µm, in a range from 0.2 µm to 5 µm, in a range from 0.3 µm to 5 µm, or in a range from 0.5 µm to 5 µm (Edwards - paragraph 0124).
Regarding Claim 15, Edwards in view of Hojer teaches: The device according to claim 1, wherein the particle measurement device comprises between 1 and 256 channels, between 4 and 256 channels, or at least 4 to 256 spectral channels which are adapted to detect light (Edwards - paragraph 0064).
Regarding Claim 23, Edwards in view of Hojer teach: The device according to claim 1, wherein the measurement line or the particle measurement device comprise a heater configured to keep the temperature at a preset value (Hojer – paragraph 0034-0035).
Regarding Claim 25, Edwards in view of Hojer teach: The device according to claim 1, but fail to mention wherein a diameter of the measurement I ne is smaller than a diameter of the inlet line and a diameter of the breathing line.
It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention on Edwards in view of Hojer to include wherein a diameter of the measurement line is smaller than a diameter of the inlet line and/or a diameter of the breathing line as it has been held that changes in size and shape, where the changes in dimensions would not perform differently than the prior art device, requires only routine skill in the art (See MPEP 2144.04).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Hojer in view of Heanue et al. (US 2020/0245899 A1), hereinafter Heanue.
Regarding Claim 3, Edwards in view of Hojer teaches: The device according to claim 1, but fails to mention wherein the interface is fluidly sealable to block air flow through the interface.
Heanue teaches a breathing apparatus (abstract) wherein a valve is used to block airflow through the interface (claim 5). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Edwards in view of Hojer to include wherein the interface is fluidly sealable to block air flow through the interface to avoid inadvertently allowing fluids to pass through the interface when a patient is not breathing into it.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Hojer in view of Shetty et al. (US 2017/0270260 A1), hereinafter Shetty.
Regarding Claim 6, Edwards in view of Hojer teaches: The device according to claim 1 but fails to mention wherein the measurement line or an inner wall of the measurement line and/or the particle measurement device comprise at least one antistatic and/or electrically conductive component.
Shetty teaches a measurement device (figure 2) wherein the measurement line or an inner wall of the measurement line and/or the particle measurement device comprise at least one antistatic and/or electrically conductive component (paragraph 0095). It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention on Edwards in view of Hojer to include wherein the measurement line or an inner wall of the measurement line and/or the particle measurement device comprise at least one antistatic and/or electrically conductive component to minimize the deposition of aerosolized droplets on the inner surface of the body.
Claim(s) 12, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Hojer in view of Call et al. (US 2004/0232052 A1), hereinafter Call.
Regarding Claim 12, Edwards in view of Hojer teaches: The device according to claim 1, wherein the particle measurement device is an optical particle measurement device which comprises at least one light source (paragraph 0064), but fails to explicitly mention wherein the light source is adapted to emit polychromatic light and/or light with at least one wavelength in a range from 380 nm to 490 nm.
Call teaches the use of multi-wavelength light sources for use with a particle measurement device (paragraph 0309). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Edwards in view of Hojer to include wherein the light source is adapted to emit polychromatic light and/or light with at least one wavelength in a range from 380 nm to 490 nm as the use of different wavelengths allows for detection of particles of different sizes.
Regarding Claim 26, Edwards in view of Hojer teach: The device according to claim 1, wherein the particle measurement device is an optical particle measurement device which comprises at least one light source (Edwards paragraph 0064), but fails to explicitly mention wherein the light source is adapted to emit polychromatic light and light with at least one wavelength in a range from 380 nm to 490 nm.
Call teaches the use of multi-wavelength light sources for use with a particle measurement device (paragraph 0045, 0309). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Edwards in view of Hojer to include wherein the light source is adapted to emit polychromatic light and light with at least one wavelength in a range from 380 nm to 490 nm as the use of different wavelengths allows for detection of particles of different sizes.
Claim(s) 13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Hojer in view of Call further in view of Weib et al. (US 2014/0092386 A1), hereinafter Weib.
Regarding Claim 13, Edwards in view of Hojer in view of Call teach: The device according to claim 12, but fail to mention wherein the particle measurement device comprises an aerosol spectrometer, wherein particles of exhaled air are arranged inside a measuring cell of the aerosol spectrometer to illuminate the particles by a light beam, wherein scattering light of the particles is received by a sensor and scattering light signals of the particles are registered by intensity spectroscopically such that a size distribution of the scattering light signals is determined to represent a particle size distribution.
Weib teaches the use of an aerosol spectrometer for particle detection (paragraph 0003, 0005). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Edwards in view of Hojer in view of Call to include wherein the particle measurement device comprises an aerosol spectrometer, wherein particles of exhaled air are arranged inside a measuring cell of the aerosol spectrometer to illuminate the particles by a light beam, wherein scattering light of the particles is received by a sensor and scattering light signals of the particles are registered by intensity spectroscopically such that a size distribution of the scattering light signals is determined to represent a particle size distribution (as the substitution of one detector for another would have yielded predictable results to one of ordinary skill.
Regarding Claim 14, Edwards in view of Hojer in view of Call in view of Weib teach: The device according to claim 13. Weib further teaches: wherein a direction of movement of the particles inside the measuring cell, a direction of the light beam inside the measuring cell and a direction of the scattering light are arranged substantially perpendicular to one another, respectively (figure 1).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Hojer in view of Chen et al. (KR 20230159894 A), hereinafter Chen.
Regarding Claim 24 Edwards in view of Hojer teach: the device according to claim 1, wherein the measurement line comprise at least one check valve (Edwards element 16). Edwards does not mention the particle measurement device having a check valve.
Chen teaches a particle measurement device (element 1000) comprising a check valve (element 1012). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention wherein the particle measurement device also has a check valve as the substitution of one particle measuring device for another would have yielded predictable results to one of ordinary skill.
Response to Amendments and Arguments
Regarding 112 Rejections, Applicant’s amendments have been fully considered. The previous rejections are withdrawn.
Regarding Prior Art rejections, Applicant argues that Edwards and Hojer are improperly combined. Applicant argues that Hojer relies on a fundamentally different measurement principle and further argues that the heater in Hojer is not applied to a measurement line.
Examiner disagrees and notes that Hojer clearly teaches thermostatting device components and thus meets the claimed limitations. Hojer is only referenced to teach thermostatting the device. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
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 JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at 571-272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791