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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/06/26 has been entered.
Response to Arguments
Applicant’s arguments, filed 02/26/26, with respect to the rejection(s) of claim(s) under 35 USC 112 have been fully considered and are persuasive in light of the amendment to claim 1, “a flow mass controller.”
With respect to the applicant’s arguments regarding the rejection of claims under 35 USC 103, the arguments are not persuasive with respect to whether Al-Taisan serves as prior art. The annexes to the 1.132 submitted from Professor Peder Norberg and Mrs. Alyson Bird should be separately submitted under 1.132, not annexes to the inventor’s own affidavit. Even considering the information provided therein, the burden of proof has not been met that the reference was not publicly available since a description of who the document was available to has not been provided. The documents simply say it was available only to “staff only” however there is no explanation of who “staff” includes (the entire university staff, only the department) and how many people that would include. Additionally, it needs to be shown that those who did have access were aware of the confidentiality expectation.
Furthermore, and more concerning is that it appears that the reference also is evidence that the current application’s subject matter is not actually applicant’s own invention but rather the work of another. For this reason, a new rejection appears below under 35 USC 101. The common understanding of a Ph.D thesis is that it represents the candidate’s own contribution to the field. It is unclear that if work in the thesis is the work of Al-Taisan, the applicants had knowledge of that work prior to their own publishing of the same information, and the work described by Al-Taisan is the core inventive concept of the current application why is Al-Taisan not listed as an inventor on the application.
The prior art rejection is below as updated with respect to the claim amendments to more fully demonstrate the completeness of the Al-Taisan reference in overlapping subject matter.
Claim Rejections - 35 USC § 101 and 35 USC § 115
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
35 U.S.C. 115(a) reads as follows (in part):
An application for patent that is filed under section 111(a) or commences the national stage under section 371 shall include, or be amended to include, the name of the inventor for any invention claimed in the application.
The present application sets forth the incorrect inventorship because there is sufficient reason to believe that a not insignificant portion of the current application was originally invented by another. The cited reference by Al-Taisan et al. “Cavity-Enhanced Laser-Induced Fluorescence for Real-time Breath Acetone Monitoring” was known to the applicants, written by a student with the inventors being the thesis advisors prior to filing the application and discloses a significant percentage if not all of the inventive concept. It is generally understood that a thesis is a student’s own contribution to the field. If this is incorrect, applicants are invited to provide evidence otherwise.
Claims 1-4, 6-16, and 21-23 are rejected under 35 U.S.C. 101 and 35 U.S.C. 115 for failing to set forth the correct inventorship for the reasons stated above.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 3, 4, 6, 7, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Paldus et al. U.S. Publication 2005/0134836 in view of Al-Taisan et al. “Cavity-Enhanced Laser-Induced Fluorescence for Real-time Breath Acetone Monitoring.”
With respect to claim 1, Paldus discloses a cavity enhanced detector comprising:
A light source with an emission spectrum that overlaps with an absorption of the analyte, a pair of reflective mirrors located on an optical axis to form an optical cavity, the cavity having a sample inlet and a sample outlet (Figure 6, light source = laser source)
A fluorescence detector located at a location not on the cavity axis and arranged to provide a first signal in response to fluorescence within the cavity (Figure 6, detector = photodetector 6.6)
A photon detector located axially external to the cavity and arranged to provide a second signal (Figure 6, extinction photodetector 6.5)
Wherein the apparatus including the light source, the cavity and the axial photon detector comprises a cavity-enhanced absorption spectrometer (Figure 6, P.0021)
Wherein the apparatus including the fluorescence detector is configured to comprise a cavity-enhanced laser induced fluorescence spectrophotometer (Figure 6, P.0040)
Means for supplying an analyte free gas sample or an analyte containing gas sample to the cavity through the inlet (Figure 6, inherent that sample comes from somewhere)
A processor adapted to receive a first signal from the fluorescence detector and a second signal from the axial photon detector, and further adapted to provide a measurement of the analyte concentration in the sample (P.0021, P.0043)
Wherein a flow body is located between the sample inlet and the sample outlet, the flow body comprising a chamber extending along a direction of sample flow between the sample inlet and the sample outlet, the flow body further comprising a light source inlet and a light source outlet arranged to provide a path for a light source through the chamber, the path extending transversely of the direction of sample flow (Figure 6, flow body = flow cell 5, inlet = sample flow label arrow, outlet = opposite side arrow, light source inlet and outlet = walls 5, light path = 1)
The flow body further comprising an aperture communicating with the fluorescence photon detector in a direction transverse to the path of the light source (Figure 6, aperture = wall 5 which allows light to pass through to fluorescence detector 6.6)
However, Paldus fails to disclose the light source inlet and light source outlet are openings and the optical path does not pass through a wall of the flow body. Additionally, Paldus fails to disclose the chamber increases in a dimension at a minimum value at the sample inlet to a maximum value in the vicinity of the light path and decreasing to a value smaller than the maximum at the sample outlet.
Al-Taisan discloses a CELIF and flow cell body comprising:
A light source with an emission spectrum that overlaps with an absorption fo the analyte, a pair of reflective mirrors located on an optical axis to form an optical cavity, the cavity having a sample inlet and a sample outlet (Figure 2.2, emission spectrum = 266 nm, absorption = 250-300 nm, page 17, description 2.2, “stable optical cavity formed by two concave mirrors”, Figure 3.1)
A fluorescence detector located at a location not on the cavity axis and arranged to provide a first signal in response to fluorescence within the cavity (Figure 2.4, Figure 3.1, LIF PMT)
A photon detector located axially external to the cavity and arranged to provide a second signal (Figure 3.1, CRD PMT)
The apparatus comprises a cavity-enhanced absorption spectrometer (abstract, page 17 description a cavity enhanced spectroscopy with photometer = cavity enhanced absorption spectrometer)
The apparatus including the fluorescence detector is configured to comprise a CELIF spectrophotometer (Figure 3.1 description)
A flow mass controller for supplying an analyte free gas sample or an analyte containing gas sample to the cavity through the inlet (Figure 4.1, bottom of page 57)
A processor adapted to receive a first signal from the fluorescence detector and a second signal from the axial photon detector and further adapted to provide a measurement of the analyte concentration in the sample (Page 54, processor = data acquisition)
A flow body located between the sample inlet and sample outlet, the flow body comprising a chamber extending along a direction of sample flow between the sample inlet and sample outlet, the flow body further comprising a light source inlet and light source outlet arranged to provide a path for a light source through the chamber, the path extending transversely of the direction of the sample flow, wherein the path does not pass through a wall of the flow body (Figure 4.1, sample inlet = gas inlet, sample outlet = gas outlet, light source inlet = blue laser beam arrow, page 56 paragraph 4.1)
The flow body further comprising an aperture communicating with the fluorescence photon detector in a direction transverse to the path of the light source (Figure 4.1, aperture inherent to allow fluorescence to pass through to detector)
The chamber has a dimension perpendicular to the direction of sample flow, wherein the dimension increases from a minimum value at the sample inlet to a maximum value in the vicinity of the light source path and decreasing to a value smaller than the maximum value at the sample outlet (Figure 4.1, page 56 paragraph 4.1)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the windowless illumination and detection as in Al-Taisan for the illumination and detection of Paldus since particles adhere to windows and interfere with light passage to the sample (Col.1, l 30-35). Windowless illumination and detection is well known in spectroscopy for superior sensitivity, the very pursuit that Paldus is after. (P.0012)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the flow cell structure of Al-Taisan since it is taught that a very small size cavity is required to match the breath sample and allow quick measurements to match a breath length but the center area must gradually increase so the cavity matches the sight of view of the optics. Jeannotte U.S. Patent #9,989,459 teaches that gentle tapering is essential for optimizing transition velocity between areas (Col.8, l 31-34) and to prevent flow reversal and energy loss (Col.8, l 20-26) as well as how using low volume conduits allow a high thermal efficiency (Col.7, l 49-56) giving benefit to minimizing the input and outputs, while maintaining a large enough sample volume in the central section for measurement.
With respect to claim 2, 3, 4, 6, 7, 8, 10, Paldus in view of Al-Taisan discloses all of the limitations as applied to claim 1 above. In addition, Paldus discloses:
2- The light source is a laser and the light path is a laser beam (Figure 6, light source = laser)
3- the laser is a sub-nanosecond pulsed Nd:YAG laser (P.0042)
4- The flow body contains one or more flow channels (Figure 6, flow body 5 contains flow channel 6, Figure 7)
6- the dimensions of the chamber increase smoothly (Figure 7 and 8)
7-the direction of sample flow, the laser beam path, and the fluorescence detector aperture are perpendicular or orthogonal and intersect at a single point (Figure 3, Figure 8)
8- the surface of the chamber may have a smooth profile configured to minimize turbulent flow of the sample gas (Figure 6, flat sides)
10- wherein the chamber may comprise three sections: a first section adjacent the flow inlet, an optional second section, central section; and a third section adjacent to the sample outlet (Figure 6, first section = area near label 6, central section = area of intersection of photodetectors, third section = area near outlet arrow)
With respect to claim 9, 11-16, Paldus and Al-Taisan discloses all of the limitations as applied to claim 1 above. However, Paldus fails to disclose the chamber increases in a dimension at a minimum value at the sample inlet to a maximum value in the vicinity of the light path and decreasing to a value smaller than the maximum at the sample outlet.
Al-Taisan discloses a CELIF system comprising:
9-The width of a cross section of the chamber taken parallel to the sample flow increases gradually from the inlet to a maximum value in the vicinity of the laser beam path (Figure 4.1, page 56 paragraph 4.1)
10-The chamber may comprise three sections, a first section adjacent to the sample inlet, a second central section, and a third section adjacent to the sample outlet (Figure 4.1, inlet, outlet, center, page 56 paragraph 4.1)
11-The first section has a circular cross section and the circular cross section of the first section increases in size in the direction of the sample flow (Figure 4.1)
12-The second section has a circular cross section, remaining constant size in the direction of sample flow (Figure 4.1)
13-The third section has a circular cross section and the circular cross section decreases in size in the direction of sample flow (Figure 4.1)
14-The first section is configured as an expanding cone starting from the narrowest point adjacent the inlet and expanding to a widest point in the direction of the sample flow (Figure 4.1, page 56 paragraph 4.1)
15- The second section is configured as a cylinder (Figure 4.1, page 56 paragraph 4.1)
16- The third section is configured as a narrowing cone going from a widest point adjacent to the second section and decreasing in width to a narrowest point of the cone adjacent to the sample outlet (Figure 4.1, page 56 paragraph 4.1)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the flow cell structure of Al-Taisan since it is taught that a very small size cavity is required to match the breath sample and allow quick measurements to match a breath length but the center area must gradually increase so the cavity matches the sight of view of the optics. Jeannotte U.S. Patent #9,989,459 teaches that gentle tapering is essential for optimizing transition velocity between areas (Col.8, l 31-34) and to prevent flow reversal and energy loss (Col.8, l 20-26) as well as how using low volume conduits allow a high thermal efficiency (Col.7, l 49-56) giving benefit to minimizing the input and outputs, while maintaining a large enough sample volume in the central section for measurement.
With respect to claims 21-23, Paldus in view of Al-Taisan discloses all of the limitations as applied to claim 1 above. However, Paldus fails to disclose using the device to measure acetone in a patient’s breath.
Al-Taisan discloses a CELIF for monitoring acetone in breath comprising:
A cavity enhanced laser induced fluorescence spectrometer (abstract, Figure 4.1)
Measuring acetone in exhaled breath using a flow cell and CELIF (abstract)
The apparatus further comprises a breath collector connected to the inlet of the apparatus (page 7, first full paragraph “On-line sampling is achieved when the exhaled breath is directly transferred into the inlet”, Page 10, last paragraph “via a disposable mouthpiece”)
The breath collector comprise a breathing tube (page 10, last paragraph “via a disposable mouthpiece”)
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the device of Paldus to the field of breath acetone measurements as in Al-Taisan since the large number and low concentrations of trace compounds in exhaled breath require a highly sensitive and highly selective instrument. Applying the device of Paldus to the field of Al-Taisan provides an increased utility for the invention.
Additionally, using a breath collector of some sort, especially a breathing tube, as in Al-Taisan, allows the breath to be directly collected repeatably and reliably into the inlet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA CAROLE BRYANT whose telephone number is (571)272-9787. The examiner can normally be reached M-F, 12-4 pm.
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/REBECCA C BRYANT/ Primary Examiner, Art Unit 2877
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