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, filed 10/30/2025, with respect to the rejection(s) of claim(s) under 35 USC 112 have been fully considered and are partially persuasive. The applicant argues that “means for supplying…” limitation is defined in the specification as flow mass controller on page 20, lines 30-32 in the specification. However, the examiner points out that for a means plus function limitation, the structure disclosed in the written description is the corresponding structure only if the written description clearly links or associates that structure to the function recited in the means plus function claim limitation. The “means for supplying” limitation is not clearly linked or tied to the flow mass controller. The flow mass controller does seem to perform the function described in the claim, there is no indication that that is the structure being claimed. Therefore, the two rejections under 35 USC 112 remain.
The amendments to claims 9 and 10 are successful in overcoming the 112 rejections, which have now been withdrawn.
With respect to the rejection of claims under 35 USC 102, the amendments to the claims are successful in overcoming the rejection. However, a new rejection is made under 35 USC 103 Paldus in view of Berry as described below.
Finally, 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 supplied documents describing the Al-Taisan reference need to be officially entered on the record via affidavits according to MPEP Section 716. Even considering the information provided therein, the burden of proof has not been met that the reference was not publicly available. Furthermore, 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.
Claim Rejections - 35 USC § 112
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 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no structure in the specification drawn to the “means for supplying” a sample.
Claim 1 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “means for supplying” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The balance of claims are likewise rejected for failing to correct the deficiencies in the claim upon which they depend.
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 Berry et al. U.S. Patent #7,435,963.
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 s ample 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.
Berry et al. discloses a flow cell comprising:
A light source (Col.2, l 39-43)
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 (Col.2, l 39-43, Figure 1, Col.5, l 53-57)
Means for supplying a gas sample to the cavity through the inlet (Col.2, l 1-4, means = pump)
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 opening and a light source outlet opening arranged to provide a path for a light source through the chamber, the path extending transversely of the direction of sample flow, wherein the path does not pass through a wall of the flow body (Col. 1, l 46-52, Col.5, l 43-49, Col.2, l 59-62)
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 Berry for the illumination and detection of Paldus since as taught by Berry, 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)
With respect to claim 2, 3, 4, 6, 7, 8, 10, Paldus in view of Berry 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 claims 3, 7,
Claim(s) 5, 9, 11-16 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Paldus et al. U.S. Publication 2005/0134836 and Berry et al. U.S. Patent #7,435,963 and further in view of Al-Taisan et al. “Cavity-Enhanced Laser-Induced Fluorescence for Real-time Breath Acetone Monitoring”.
With respect to claim 5 and 9, 11-16, Paldus and Berry 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 and flow cell body comprising:
1-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 (Figure 4.1, sample inlet = gas inlet, sample outlet = gas outlet, light source inlet = blue laser beam arrow, page 56 paragraph 4.1)
5-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)
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 Berry 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
THIS ACTION IS MADE FINAL. 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 REBECCA CAROLE BRYANT whose telephone number is (571)272-9787. The examiner can normally be reached M-F, 12-4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached at 5712723995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA C BRYANT/ Primary Examiner, Art Unit 2877
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