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 .
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.
Election/Restrictions
Applicant’s election without traverse of Invention I corresponding to claims 1-15 in the reply filed on November 4, 2025 is acknowledged.
Applicant has misstated that Invention I corresponds to claims 1-20, Invention I as noted in the Restriction Requirement corresponds to claims 1-15, Invention II corresponds to claims 16-20. The restriction requirement still stands as there is a search burden and as noted in the Restriction Requirement the product as claimed can be used in a materially different process of using that product such as to calibrate monitors.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 4, 2025.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1: “a spectrophotometer, in the housing” should read “a spectrophotometer disposed in the housing”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
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.
Claims 1-15 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 illumination" in Line 8. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “an operating wavelength range”, and the claim also recites “a wavelength between 2080 nm and 2400 nm” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, and 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tran et al. (US 2021/0212606).
Regarding claim 1, Tran teaches a system (Abstract), comprising:
a housing, sized and dimensioned to be disposed about the body of a patient (Paragraph 0101; “a non-invasive sensor from a wearable device, a mobile phone or watch can act as a spectrometer”; Figure 6B; Paragraphs 0170-0171); and
a spectrophotometer, in the housing (Paragraph 0101; “a mobile phone or watch can act as a spectrometer”),
the spectrophotometer being configured to illuminate the skin of the patient with probe light and to perform measurements of return light (Paragraph 0101; “The light may be transmitted through the ear lobe or may be caused to impinge on the skin surface of the tissue (such as a patient's wrist) at an angle where it is absorbed by tissue material near the surface and reflected as diffuse radiation.”),
the return light being light returning, to a photodetector of the spectrophotometer, from the skin of the patient, as a result of the illumination by the probe light (Paragraph 0101; “The light may be transmitted through the ear lobe or may be caused to impinge on the skin surface of the tissue (such as a patient's wrist) at an angle where it is absorbed by tissue material near the surface and reflected as diffuse radiation.”),
the spectrophotometer having an operating wavelength range including a wavelength between 2080 nm and 2400 nm (Paragraph 0101; “In the embodiment utilizing diffuse reflectance, a near infrared bandwidth in the range of 1800 to 3400 nm is preferred.”).
Regarding claim 2, Tran teaches wherein the spectrophotometer is configured to measure urea nitrogen (Paragraph 0099 and Claim 21).
Regarding claim 4, Tran teaches further comprising a radio in the housing, wherein the system is configured to transmit data, via the radio, the data being based on the measurements (Paragraph 0173).
Regarding claim 11, Tran teaches wherein the measurements are suitable for estimating a concentration of a biomarker in tissue or fluid of the patient (Paragraph 0099).
Regarding claim 12, Tran teaches wherein the biomarker is selected from the group consisting of water, glucose, hemoglobin, creatinine, urea, lactate, ethanol, and albumin (Paragraph 0099).
Regarding claim 13, Tran teaches further comprising a band configured to secure the housing against the skin of the patient (Paragraphs 0075 and 0171).
Regarding claim 14, Tran teaches wherein the band is configured to secure the housing against the skin of the wrist of the patient (Paragraphs 0075 and 0171).
Regarding claim 15, Tran teaches further comprising an adhesive patch configured to secure the housing against the skin of the patient (Paragraphs 0075 and 0317).
Claim Rejections - 35 USC § 103
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (US 2021/0212606) in view of Filipovic et al. (US 2016/0106370).
Regarding claim 3, Tran is silent on the volume of the housing. Filipovic teaches wherein the housing has a volume of less than 100 cubic centimeters (Paragraph 0056). It would have been obvious to one of ordinary skill in the art to have modified Tran with Filipovic since Filipovic teaches the sizing as being conventional (Paragraph 0056 of Filipovic) and since the courts have held the following: In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP § 2144.04-IV-A.
Claim(s) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (US 2021/0212606) in view of Gerber et al. (US Patent No. 9700661).
Regarding claim 5, Tran is silent on transmitting data to a dialysis system. Gerber teaches wherein the transmitting of the data comprises transmitting the data to a dialysis system (Column 8, Lines 2-10 and Column 8, Line 25-Column 9, Line 4; Claims 8-9). It would have been obvious to one of ordinary skill in the art to have modified Tran with Gerber because it allows for quicker treatment and/or adjustment of treatment as needed (Column 8, Line 25-Column 9, Line 4 of Gerber).
Regarding claim 6, Tran is silent on transmitting data to a dialysis system. Gerber teaches wherein the transmitting of the data to the dialysis system comprises transmitting the data to the dialysis system wirelessly (Column 8, Lines 2-10 and Column 8, Line 25-Column 9, Line 4; Claims 8-9). It would have been obvious to one of ordinary skill in the art to have modified Tran with Gerber because it allows for quicker treatment and/or adjustment of treatment as needed (Column 8, Line 25-Column 9, Line 4 of Gerber).
Regarding claim 7, Tran is silent on transmitting data to a dialysis system. Gerber teaches wherein the transmitting of the data to the dialysis system comprises transmitting the data during a dialysis session, the data being based on measurements performed during the dialysis session (Column 8, Lines 2-10 and Column 8, Line 25-Column 9, Line 4; Claims 8-9). It would have been obvious to one of ordinary skill in the art to have modified Tran with Gerber because it allows for quicker treatment and/or adjustment of treatment as needed (Column 8, Line 25-Column 9, Line 4 of Gerber).
Regarding claim 8, Tran is silent on transmitting data to a dialysis system. Gerber teaches wherein the transmitting of the data to the dialysis system comprises transmitting the data during a dialysis session, the data being based on measurements performed before the dialysis session (Column 8, Lines 2-10 and Column 8, Line 25-Column 9, Line 4; Claims 8-9). It would have been obvious to one of ordinary skill in the art to have modified Tran with Gerber because it allows for quicker treatment and/or adjustment of treatment as needed (Column 8, Line 25-Column 9, Line 4 of Gerber).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (US 2021/0212606) in view of Rice et al. (US 2021/0022623).
Regarding claim 9, Tran is silent on the PPG and SPG. Rice teach further comprising a photoplethysmography (PPG) sensor and a speckle plethysmography (SPG) sensor (Paragraph 0060). It would have been obvious to one of ordinary skill in the art to have modified Tran with Rice because it allows for non-invasive quantitative measurement and/or qualitive characterization of physiological parameters of a patient (Paragraph 0008 of Rice).
Regarding claim 10, Tran and Rice teaches wherein the measurements are suitable for estimating a quantity selected from the group consisting of heart rate, blood pressure, blood flow, heart rate variability, hemoglobin, blood oxygen saturation, and respiratory rate (Paragraph 0008 of Tran; Paragraph 0060 of Rice). It would have been obvious to one of ordinary skill in the art to have modified Tran with Rice because it allows for non-invasive quantitative measurement and/or qualitive characterization of physiological parameters of a patient (Paragraph 0008 of Rice).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Wieringa et al. (US 2021/0138132), White et al. (US 2021/0177283), Gardner et al. (US 2023/0039055).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JASON SIMS can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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