DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because greyscale images are permitted under 37 CFR 1.84(b)(1) if they are the only practical medium to illustrate the claimed invention and must be of sufficient quality that all details are reproducible.
FIGS. 2, 3, 5, 7, 8, 9, 10, 11, 12, 13 and 14 should be line drawings. The current greyscale images may not be easily reproducible and the depicted images themselves would be understood absent the greyscale.
FIG. 15 may qualify for a color drawing petition under 37 CFR 1.85(a)(2), as color appears necessary to convey the quantitative chromophore concentration information depicted.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The Examiner notes that FIG. 15 may qualify for a color drawing petition under
Specification
The disclosure is objected to because of the following informalities:
Abstract calls the first end of the second optical fibers 12a and should instead be 11b. This same error repeats in the description of FIG. 16.
The specification refers to cancelled claims, including Claims 31-37, for example in para. [0102]. All references to the claims in the specification should be removed.
Appropriate correction is required.
Claim Objections
The claims are objected to because of the following informalities:
Claim 2: “of a corresponding a number of” should read “of a corresponding number of” and “of separate light receiving regions on (40) the” should read “of separate light receiving regions (40) on the”.
Claim 8: “control unit (3)” should instead read “control unit (6)”;
Claim 10: “analyzing unit (4)” should instead read “analyzing unit (5)”;
Claim 17: “first optical fiber (12)” should instead read “first optical fiber (11)”;
Claim 31, line 8 reads “first optical fibers (12)” and should instead read “first optical fibers (11)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-8, 10, 12-21 and 31 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the respective first optical fiber". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the indefinite limitation has been deemed to claim simply “the first optical fiber”.
Regarding Claims 3, 13 and 15, the phrase "particularly" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For purposes of examination the indefinite limitation has been deemed to claim that the limitations following the phrase are part of the claimed invention.
Regarding Claim 3, the limitations “and/or” cascade four times in a row, creating uncertain scope in the claims - it is unclear what is included and excluded in the claim. For purposes of examination the indefinite limitation has been deemed to claim only one of the “and/or” limitations are required.
Regarding Claim 3, the limitations “a distance” (recited twice) render the claim indefinite because it is unclear if these are the same or different distances. For purposes of examination the indefinite limitation has been deemed to claim different distances.
Regarding Claims 3 and 8, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For purposes of examination the indefinite limitation has been deemed to claim that the limitations following the phrase are part of the claimed invention.
Regarding Claim 21, the limitation “a further plurality of first optical fibers (11)” renders the claimed indefinite, as the same reference (11) is used for the originally claimed plurality from Claim 1 and also the “further” plurality. It is unclear if these fibers are the same or different fibers. For purposes of examination the indefinite limitation has been deemed to claim different fibers.
Claim 21 recites the limitation "each light emitting region". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the claim has been treated as depending from Claim 2 to provide proper antecedent basis.
Claim 31 recites the limitation "the control unit (6)". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the indefinite limitation has been deemed to claim “a control unit (6)”.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
Claim 1 and respective dependent claims are allowable over the prior art of record. The closest prior art of record includes Photonic textiles for pulse oximetry to Rothmaier et al. (hereinafter, Rothmaier) and Light Emitting Fabric Technologies for Photodynamic Therapy to Mordon et al. (hereinafter, Mordon).
Regarding Claim 1, Rothmaier discloses a medical device for determining an oxygen saturation in a tissue of a subject (Abstract, “…we demonstrate the design and performance of a textile based pulse oximeter…”, comprising inter alia:
a sensor comprising a flexible textile comprising a plurality of first optical fibers and a plurality of second optical fibers, wherein the first optical and second optical fibers each comprise a first end and a second end (The first optical fibers are a first grouping of 4 POFs delivering 690 nm light plus the a second grouping 4 POFs delivering 830 nm light, and the second optical fibers are the 16 detector POFs – each of the 24 fibers has a proximal end glued into an F-SMA connector (e.g., the “first end”) and a distal end bent 90 degrees toward the tissue (e.g., the “second” end) (2.3 Embroidered specimens “The light emitter consisted of 4 POF delivering light of 690 nm wavelength and 4 POF delivering 830 nm. The light detector consisted of 16 POF... POF length, from connector to the point of irradiation or light emission, was 30 cm each… fibers were glued with standard epoxy glue into F-SMA connectors and polished.”),
wherein the sensor further comprises a first light generating unit (2.3 Embroidered specimens “POF length, from connector to the point of irradiation or light emission…”) (2.6 Pulse waves “Specimens G and H, respectively, were connected straight to the OxiplexTS…”) configured to generate and couple light of a first wavelength (The first optical fibers are a first grouping of 4 POFs delivering 690 nm light plus the a second grouping 4 POFs delivering 830 nm light) into a first grouping the first ends of the first optical fibers (2.3 Embroidered specimens “POF length, from connector to the point of irradiation or light emission…”) (2.6 Pulse waves “Specimens G and H, respectively, were connected straight to the OxiplexTS…”) and to generate and couple light of a second wavelength (The first optical fibers are a first grouping of 4 POFs delivering 690 nm light plus the a second grouping 4 POFs delivering 830 nm light) into a second grouping of the first ends of the first optical fibers (2.3 Embroidered specimens “POF length, from connector to the point of irradiation or light emission…”) (2.6 Pulse waves “Specimens G and H, respectively, were connected straight to the OxiplexTS…”), the first wavelength being different from the second wavelength (e.g., 690 nm versus 830 nm) wherein the respective first optical fiber is configured to emit light via a light emitting section of the respective first optical fiber to irradiate tissue of the subject, the light emitting section being arranged between the first end and the second end of the respective first optical fiber (Schiffli specimen H discloses that each first optical fiber is configured to emit light via a light emitting section being a hook having a radius between 0.25 and 1 mm formed by the fiber crossing to the opposite side of the textile substrate and back with the light emitting section arranged along the fiber’s length between the first end (F-SMA connector) and the second end) (2.1 Textile techniques “Schiffli technique (which allows retention stitches on both sides of a substrate) guides the POF on one side of a PET weave to the place of interest, crosses to the opposite side and back, which will lead to random loops due to POF twisting (Fig. 1, right scheme).”) (2.3 Embroidered specimens “H was manufactured using the Schiffli technique (Fig. 3, lower left and lower right side; the resulting loops had randomly distributed radii between 0.25 and 1 mm; approximately 3 fibers with the corresponding loops were irradiated at the same time in the following experiments…”), and wherein the respective second optical fiber (2.3 Embroidered specimens “The light detector consisted of 16 POF... POF length, from connector to the point of irradiation or light emission, was 30 cm each… fibers were glued with standard epoxy glue into F-SMA connectors and polished.”) comprises a light receiving section configured to receive light coming from the tissue, the light receiving section being arranged between the first end and the second end of the respective second optical fiber (2.1 Textile techniques “Schiffli technique (Each second optical fiber runs from its first end (F-SMA connector at the OxiplexTS photomultiplier) to a mid-fiber Schiffli loop. The light receiving section 22, which receives light from the tissue via bend-coupling, and the fiber continues to its second end, placing the receiving section between the two ends.) (which allows retention stitches on both sides of a substrate) guides the POF on one side of a PET weave to the place of interest, crosses to the opposite side and back, which will lead to random loops due to POF twisting (Fig. 1, right scheme).”),
wherein the sensor further comprises a first light detector unit operatively connected to the second optical fibers and configured to detect light received by the light receiving section of the respective second optical fiber (The OxiplexTS photomultiplier tube is the first light detector unit, connected via F-SMA connectors to the first ends of the 16 second optical fibers, detecting the light received at the mid-fiber Schiffli loops.) (FIG. 5 caption “The OxiplexTS near infrared spectrophotometer includes laser diodes of 690 and 830 nm wavelength and a photomultiplier tube detector.”,
an analyzing unit configured to determine an oxygen saturation value of the tissue using intensities of light detected by the first light detector unit (2.7 Arterial oxygen saturation, see SpO2 equations at top of pg. 12982) (2.6 Pulse waves “Data has been exported as ASCII to Excel 2003 (Microsoft, USA) and Origin 8.0 (OriginLab, USA) for further processing.”).
Rothmaier discloses the claimed invention as set forth and cited above except for expressly disclosing wherein the sensor further comprises a first light generating unit configured to generate and couple light of a first wavelength into the first ends of the first optical fibers and to generate and couple light of a second wavelength into the second ends of the first optical fibers, the first wavelength being different from the second wavelength, because Rothmaier only discloses where there is a first grouping of fibers that receive 690 nm light at their respective first ends and a second grouping 4 POFs delivering 830 nm light at their respective first ends (i.e., separate fibers for differing wavelengths).
Mordon teaches a light emitting fabric technologies for photodynamic therapy (see Title), with wearable fibers with light propagation (see all or Techniques, Principle) (Leakage of light due to marco-bending “The side‐emission is obtained by inducing macrobending of POF. This macrobending is due to specific architecture weaving of textile structures.”), where there are multiple fibers with first and second ends, where there are two light sources, one at each of the first and second ends of the multiple fibers (Techniques, Principle “Use of two light sources, one at each end of the SEOF…”) (Embroidery-based light emitting fabric “Both ends of the optical fiber were coupled to the light source.”).
However, Mordon, nor any other prior art of record teaches where the light sources at the first and second ends of the multiple fibers each have first and second (e.g., different) wavelengths. One having an ordinary skill in the art at the time the invention was filed would have not found it obvious to couple two light sources generating of two different wavelengths to first and second ends of the optical fibers - the counter propagating approach as set forth in Claim 1 appears as a novel arrangement over the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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