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 .
Response to Amendment
The amendment filed on November 11, 2025 was considered by the examiner. Claims 1-2, 4-6, 11-16, and 18-25 are pending in the application.
Claim Objections
Claim 19 is objected to because of the following informalities:
in claim 19, line 12: “population” should be inserted before “slope”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
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.
Claims 1-2, 4-6, 11-16, and 18-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards abstract ideas without significantly more.
Claim 1 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “determine a difference in voltage value for a light emitting diode based on a first voltage at the light emitting diode at a first current and a second voltage at the light emitting diode at a second current, wherein the difference in voltage value is dependent on a temperature at the light emitting diode” (see specification ¶[0098]) is being interpreted as mathematical calculations/evaluations. The recitation “determine an operating temperature for the light emitting diode based at least in part on the difference in voltage value and a population slope factor” (see specification ¶[0100] and ¶[0102]-[0103]) is being interpreted as mathematical calculations/evaluations. The recitation “compensate for a shift in wavelength due to the operating temperature, comprising adjusting an estimated wavelength of the light emitting diode based on the operating temperature or adjusting a calibration of the light emitting diode based on the operating temperature” (see specification ¶[0101]-[0107]) is being interpreted as mathematical calculations/evaluations. The recitation “determine an oxygen saturation level based on the intensity signal and the adjusted estimated wavelength or the adjusted calibration” (see specification ¶[0064]-[0065]) is being interpreted as mathematical calculations/evaluations and/or judgements (i.e., comparisons and/or judgements to compare/identify the values in the table). The recitations are computer-implemented, as indicated in the specification (see ¶[0045], ¶[0077], ¶[0079], and ¶[0194]-[0199]), and the claim lines 1-2 and 8.
Claim 19 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “determining a difference in voltage value for the light emitting diode based on a first voltage at the light emitting diode for the first current and a second voltage at the light emitting diode for the second current” (see specification ¶[0098]) is being interpreted as mathematical calculations/evaluations. The recitation “determining an operating temperature for the light emitting diode based at least in part on the difference in voltage value and the slope factor” (see specification ¶[0100] and ¶[0102]-[0103]) is being interpreted as mathematical calculations/evaluations. The recitation “compensate for a shift in wavelength due to the operating temperature, comprising adjusting an estimated wavelength of the light emitting diode based on the operating temperature or adjusting a calibration of the light emitting diode based on the operating temperature” (see specification ¶[0101]-[0107]) is being interpreted as mathematical calculations/evaluations. The recitation “determining an oxygen saturation level based on the intensity signal and the adjusted estimated wavelength or the adjusted calibration” (see specification ¶[0064]-[0065]) is being interpreted as mathematical calculations/evaluations and/or judgements (i.e., comparisons and/or judgements to compare/identify the values in the table). The recitations are computer-implemented, as indicated in the specification (see ¶[0045], ¶[0077], ¶[0079], and ¶[0194]-[0199]), and the claim line 9.
Claim 20 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “determine a difference in voltage value for the light emitting diode based on a first voltage at the light emitting diode for a first current and a second voltage at the light emitting diode for a second current” (see specification ¶[0098]) is being interpreted as mathematical calculations/evaluations. The recitation “determine an operating temperature for the light emitting diode based at least in part on the difference in voltage value and a population slope factor” (see specification ¶[0100] and ¶[0102]-[0103]) is being interpreted as mathematical calculations/evaluations. The recitation “compensate for a shift in wavelength due to the operating temperature, comprising adjusting an estimated wavelength of the light emitting diode based on the operating temperature or adjusting a calibration of the light emitting diode based on the operating temperature” (see specification ¶[0101]-[0107]) is being interpreted as mathematical calculations/evaluations. The recitation “determine an oxygen saturation level based on the intensity signal and the adjusted estimated wavelength or the adjusted calibration” (see specification ¶[0064]-[0065]) is being interpreted as mathematical calculations/evaluations and/or judgements (i.e., comparisons and/or judgements to compare/identify the values in the table). The recitations are computer-implemented, as indicated in the specification (see ¶[0045], ¶[0077], ¶[0079], and ¶[0194]-[0199]), and the claim lines 3 and 8-9.
Step 1: This part of eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claims 1 and 20 recite a device/system, which are directed towards a machine/manufacture (a statutory category of invention). Claim 19 recites a method, which is directed towards a process (a statutory category of invention). Step 1: YES.
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(a)(2)(III). The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgements, and opinions. As discussed in the claim interpretation section, the limitations include, under the BRI, multiple evaluations and judgement. Accordingly, the limitations as seen in claims 1, 19, and 20 recite judicial exceptions (abstract ideas that fall within the mental process grouping). No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Furthermore, as explained in MPEP 2106.04(a)(2)(I). The courts consider mathematical calculations, when the claim is given its BRI in light of the specification, as falling within the “mathematical concept” grouping of abstract ideas. A claim does not have to recite “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using a mathematical method, or “performing” a mathematical operation, may also be considered a mathematical calculation when the BRI of the claim in light of the specification encompasses a mathematical calculation. As discussed in the claim interpretation section, the limitations include, under the BRI, mathematical calculations/evaluations. Accordingly, the limitations as seen in claims 1, 19, and 20 recite judicial exceptions (abstract ideas that fall within the mathematical calculations grouping of mathematical concepts).
Alternatively or additionally, these steps describe the concept of using implicit mathematical formulas (i.e., calculations for the difference in voltage, temperature, and oxygen saturation level) to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts (Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
In particular, claim 1 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
for measuring oxygen saturation, including:
determine a difference in voltage value for a light emitting diode based on a first voltage at the light emitting diode at a first current and a second voltage at the light emitting diode at a second current, wherein the difference in voltage value is dependent on a temperature at the light emitting diode;
determine an operating temperature for the light emitting diode based at least in part on the difference in voltage value and a population slope factor, the population slope factor defined by characterization of a population of light emitting diodes at a plurality of test temperatures;
compensate for a shift in wavelength due to the operating temperature, comprising adjusting an estimated wavelength of the light emitting diode based on the operating temperature or adjusting a calibration of the light emitting diode based on the operating temperature;
determine an oxygen saturation level based on the intensity signal and the adjusted estimated wavelength or the adjusted calibration; and
output an indication of the oxygen saturation level.
Furthermore, claim 19 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
a method for measuring oxygen saturation, the method comprising:
determining a difference in voltage value for the light emitting diode based on a first voltage at the light emitting diode for the first current and a second voltage at the light emitting diode for the second current;
retrieving a population slope factor, the population slope factor defined by characterization of a population of light emitting diodes at a plurality of test temperatures;
determining an operating temperature for the light emitting diode based at least in part on the difference in voltage value and the slope factor;
compensate for a shift in wavelength due to the operating temperature, comprising adjusting an estimated wavelength of the light emitting diode based on the operating temperature or adjusting a calibration of the light emitting diode based on the operating temperature;
determining an oxygen saturation level based on the intensity signal and the adjusted estimated wavelength or the adjusted calibration; and
outputting an indication of the oxygen saturation level.
In addition, claim 20 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
for measuring oxygen saturation, comprising:
determine a difference in voltage value for the light emitting diode based on a first voltage at the light emitting diode for a first current and a second voltage at the light emitting diode for a second current;
determine an operating temperature for the light emitting diode based at least in part on the difference in voltage value and a population slope factor, the population slope factor defined by characterization of a population of light emitting diodes at a plurality of test temperatures;
compensate for a shift in wavelength of the light emitting diode due to the operating temperature, comprising adjusting an estimated wavelength of the light emitting diode or adjusting a calibration of the light emitting diode based on the operating temperature;
receive an intensity signal based on attenuation of the emitted photonic signal;
determine an oxygen saturation level based on the intensity signal and the adjusted estimated wavelength or the adjusted calibration; and
output an indication of the oxygen saturation level.
Step 2A Prong One: YES.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the judicial exceptions into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exceptions, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exceptions into a practical application. The claims recite additional elements related to a generic computer (i.e., the processing circuitry, the memory, and the generic computing components of the sensor and the oximetry sensor/device). The devices/method are merely instructions to implement an abstract idea on a generic computer or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Therefore, the generic computer does not integrate the abstract ideas into a practical application.
The claims recite additional elements relating to a light emitting diode and detector. The light emitting diode and the detector do not qualify as integration into a practical application because these limitations are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a high level of generality – see MPEP 2106.04(d) and MPEP 2106.05(g) using a generic component (i.e., the light emitting diode and the detector are claimed generically). In addition, Turcott (US Patent 7,909,768 – cited in prior action) teaches the use of a conventional PPG sensor comprising a light source and light detector for receiving the transmitted light (see abstract, col. 1 ln. 36 – col. 2 ln. 35, col. 6 ln. 42-58, and col. 17 ln. 45 – col. 18 ln. 3), in which the light source may comprise commercial LEDs (light emitting diodes), such as emitting red and/or infrared (see col. 5 ln. 50 – col. 6 ln. 6; Figs. 3A-3B), and the light detector may comprise a commercial photodiode PD (see col. 6 ln. 16-41; Fig. 4). Therefore, the light emitting diode and the detector do not integrate the abstract ideas into a practical application.
Step 2A Prong Two: NO.
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with Step 2A Prong Two, the claims recite additional elements directed towards a generic computer. The devices/method (claims 1, 19, and 20) utilizing a generic computer do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
The claims recite additional elements relating to a light emitting diode and detector. The light emitting diode and the detector do not qualify as significantly more because this is simply appending well-understood, routine, conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception. For example, Turcott (US Patent 7,909,768 – cited in prior action) teaches the use of a conventional PPG sensor comprising a light source and light detector for receiving the transmitted light (see abstract, col. 1 ln. 36 – col. 2 ln. 35, col. 6 ln. 42-58, and col. 17 ln. 45 – col. 18 ln. 3), in which the light source may comprise commercial LEDs (light emitting diodes), such as emitting red and/or infrared (see col. 5 ln. 50 – col. 6 ln. 6; Figs. 3A-3B), and the light detector may comprise a commercial photodiode PD (see col. 6 ln. 16-41; Fig. 4). Therefore, the light emitting diode and the detector do not amount to significantly more.
Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no
indication that the combination of elements improves the functioning of a computer, for
example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is
no indication that the combination of elements includes a particular solution to a computer-based
problem or a particular way to achieve a desired computer-based outcome. Rather, the collective
functions of the claimed invention merely provide conventional computer implementation, i.e.,
the computer is simply a tool to perform the process. Step 2B: NO.
Claims 1, 19, and 20 are not eligible.
Claims 2, 4-6, 11-16, 18, and 21-23 depend from claim 1; claim 24 depends from claim 19; and claim 25 depends from claim 20, and merely further define the abstract ideas of claims 1, 19, and 20, respectively. The claims recite no additional element that integrates the judicial exceptions into a practical application. The device/method are merely instructions to implement an abstract idea on a generic computer or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). The claims recite no additional element that adds an inventive concept to the claim and/or amounts to significantly more than the recited exception. The method/devices utilizing a generic computer do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claim 13 recites an additional element of a second light emitting diode. The second light emitting diode does not qualify as integration into a practical application because this limitation is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a high level of generality – see MPEP 2106.04(d) and MPEP 2106.05(g) using a generic component (i.e., the light emitting diode is claimed generically). The second light emitting diode does not qualify as significantly more because this is simply appending well-understood, routine, conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception. For example, Turcott (US Patent 7,909,768 – cited in prior action) teaches the use of a conventional PPG sensor comprising a light source and light detector for receiving the transmitted light (see abstract, col. 1 ln. 36 – col. 2 ln. 35, col. 6 ln. 42-58, and col. 17 ln. 45 – col. 18 ln. 3), in which the light source may comprise commercial LEDs (light emitting diodes), such as emitting red and/or infrared (see col. 5 ln. 50 – col. 6 ln. 6; Figs. 3A-3B), and the light detector may comprise a commercial photodiode PD (see col. 6 ln. 16-41; Fig. 4). Therefore, the second light emitting diode does not integrate the abstract ideas into a practical application or qualify as significantly more.
Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-6, 11-16, 19-20, 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7, 9-11, 14, 22, and 24 of copending Application No. 18/046,029 (reference application – cited by Applicant) in view of Meehan et al. (US Patent Application Publication 2014/0275890 – cited by Applicant), hereinafter Meehan.
This is a provisional nonstatutory double patenting rejection.
Regarding Claims 1-2, 4-6, 11-16, 19-20, 22-25, copending claims 1-2, 4-5, 7, 9-11, 14, 22, and 24 correspond to and teach every element of the present application claims except that the slope factor is a population slope factor. Note that the update calibration corresponds to the updating patient threshold, or alternatively, is taught by Meehan below.
Meehan teaches various methods and systems for obtaining calibration coefficients for pulse oximeter sensors (see abstract), in which calibration of the LED may involve measuring a current (operating) forward voltage of the LED (see ¶[0025]), or based off of stored calibration curves from one or more LEDs (see ¶[0026]-[0027]), in which the system may recalibrate/fine-tune the LEDs via current operating parameters (see ¶[0027] and ¶[0030]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the calibration curve/coefficient modality involving multiple LEDs that is finetuned/recalibrated with operational values as taught in Meehan with the slope in the copending claims 1-2, 4-5, 7, 9-11, 14, 22, and 24, such that multiple LEDs are utilized in the initial calibration that is later finetuned/recalibrated with the operational temperatures because (1) it is the application of a known technique to a known device/method ready for improvement to yield predictable results; and/or (2) the multiple LEDs utilized would provide a better/broader approximation of the LEDs reaction to temperature than the usage of a singular LED; and/or (3) the finetune/recalibration modality would not require as many measurements/computation at the time of use compared to only calibrating at the time of use; and/or (4) finetuning/recalibrating at the time of use would account for environmental differences between the approximated “factory” calibration compared to the usage calibration (see Meehan ¶[0025]); and/or (5) finetuning/recalibrating periodically as appropriate when changes occur would improve the accuracy of the measurements (see Meehan ¶[0030]). Here, the finetuning/recalibration of the modified Mah corresponds to the compensation of the present claim, specifically the “adjusting a calibration of the light emitting diode based on the operating temperature”.
Claims 18 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7, 9-11, 14, 22, and 24 of copending Application No. 18/046,029 (reference application – cited by Applicant) in view of Meehan as applied to claim 1 above, and in view of Harper (WIPO Publication WO 2011/026053 – cited in prior action), hereinafter Harper.
This is a provisional nonstatutory double patenting rejection.
Regarding Claim 18, the modified copending claims 1-2, 4-5, 7, 9-11, 14, 22, and 24 correspond to and teach every element of the present application claim 18, except that to initiate a timer in response to the determination of the operating temperature for the light emitting diode; and in response to determining that the timer has elapsed, determine the updated operating temperature.
Harper teaches systems/methods of an analyte monitoring device having a user interface for displaying values and alerts (see abstract), in which the time between calibrations of the analyte sensor is monitored, and once a predetermined time has elapsed, outputting an alarm/alert to inform the user it is time to recalibrate (see ¶[0108]-[0109]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to time monitoring recalibration of Berman with the calibration and further/recalibration of the copending claims 1-2, 4-5, 7, 9-11, 14, 22, and 24 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) periodically recalibrating would keep the results (i.e., the temperature and ultimately the oxygen saturation) accurate over time.
Regarding Claim 21, the modified copending claims 1-2, 4-5, 7, 9-11, 14, 22, and 24 correspond to and teach every element of the present application claim 21, except that the circuitry is further configured to pause determining the oxygen saturation level while updating a measurement of the operating temperature of the light emitting diode.
Harper teaches systems/methods of an analyte monitoring device having a user interface for displaying values and alerts (see abstract), in which the time between calibrations of the analyte sensor is monitored, and once a predetermined time has elapsed, outputting an alarm/alert to inform the user it is time to recalibrate (see ¶[0108]-[0109]), and that measurement/reporting of analyte results is stopped (i.e., paused) until calibration has settled/finished (see ¶[0250]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to time monitoring recalibration of Berman with the temperature adjusted calibration of the modified copending claims 1-2, 4-5, 7, 9-11, 14, 22, and 24 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) periodically recalibrating would keep the results (i.e., the temperature and ultimately the oxygen saturation) accurate over time; and/or (3) it would not measure/display inaccurate results (see Harper ¶[0250]) which may confuse a patient or cause incorrect diagnosis/assistance via a medical professional.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 13-16, 19-20, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Mah et al. (US Patent Application Publication 2007/0197885 – cited in prior action), hereinafter Mah, and in view of Huiku (US Patent Application 2005/0250998 – cited in prior action), hereinafter Huiku, and in view of Meehan et al. (US Patent Application Publication 2014/0275890 – cited by Applicant), hereinafter Meehan.
Regarding Claims 1, 19, and 20, Mah teaches a device for non-invasively measuring one or more analytes in a living subject utilizing multiple light sources at different wavelengths (see abstract and Fig. 1). Mah teaches a system/method for measuring an analyte (see abstract and Fig. 1), the system comprising:
a sensor device comprising a light emitting diode (¶[0030]-[0032] the light sources 4, which may be implemented as LEDs), a detector (¶[0024]-[0025] the detector 10 that produces an electrical signal proportional to the intensity of the received light; Fig. 1), and a memory (¶[0022] and ¶[0024] the computing device may be an embedded microprocessor, which runs software for controlling the lighting elements, which would necessarily have memory); and
an oximetry device comprising circuitry (¶[0030]-[0031] and ¶[0038]-[0041] the computing device 503 which may be implemented as a computer) configured to:
determine a difference in voltage value for the light emitting diode based on a first voltage at the light emitting diode at a first current and a second voltage at the light emitting diode at a second current (¶[0082]-[0098] the difference in the voltage drop ΔV between the two applied/drive currents at the light source);
determine an operating temperature for the light emitting diode based at least in part on the difference in voltage value and a slope factor stored in memory of the system (¶[0082]-[0099] the difference in the voltage drop ΔV between the two applied currents at the light source is utilized in the temperature determination, which then may be utilized during a calibration process to approximate a linear relationship, in which solving for the constants would yield an equation with a slope, because it is a linear relationship, which then is utilized for maintaining constant output intensity by monitoring temperature);
emit a photonic signal from the light emitting diode (¶[0024]-[0025] and ¶[0030]-[0032] the light sources 4 for outputting a light beam; Fig. 1);
receive, at a detector of the device, an intensity signal based on attenuation of the emitted photonic signal (¶[0024]-[0025] the detector 10 that produces an electrical signal proportional to the intensity of the received light; Fig. 1);
output an indication of the analyte (¶[0029] the computer 1 calculates and displays the concentration of the substance in question; Fig. 1).
Mah teaches that analytes may be determined for blood levels, such as urea or CO2 and other substances (see ¶[0138]), but does not specifically teach the determination of oxygen saturation.
Huiku teaches the calibration of a pulse oximeter in which the pulse oximeter has light sources and photo detector (see abstract; Figs. 1 and 16), in which the light sources may be LEDs (see ¶[0016]-[0018]), and the arrangement is capable to detect oxygen saturation after calibration is performed (see abstract, ¶[0186]-[0201], and ¶[0228]-[0229]; Figs. 8-12).
Accordingly it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the oxygen saturation determination of Huiku as the analyte determination of Mah because (1) it is the application of a known technique to a known device/method ready for improvement to yield predictable results; (2) oxygen saturation is an important metric that tells the health of the subject for a medical professional; and/or (3) Mah contemplates calculating other analytes (see Mah ¶[0138]) and Huiku teaches one such alternative analyte (oxygen saturation).
Mah teaches about the calibration of the temperature recording at the light source (see generally ¶[0080]-[0099]); however, the modified Mah does not specifically teach to compensate for a shift in wavelength due to the operating temperature, comprising adjusting an estimated wavelength of the light emitting diode based on the operating temperature or adjusting a calibration of the light emitting diode based on the operating temperature, or that the slope is a population slope.
Meehan teaches various methods and systems for obtaining calibration coefficients for pulse oximeter sensors (see abstract), in which calibration of the LED may involve measuring a current (operating) forward voltage of the LED (see ¶[0025]), or based off of stored calibration curves from one or more LEDs (see ¶[0026]-[0027]), in which the system may recalibrate/fine-tune the LEDs via current operating parameters (see ¶[0027] and ¶[0030]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the calibration curve/coefficient modality involving multiple LEDs that is finetuned/recalibrated with operational values as taught in Meehan with the slope in the modified Mah, such that multiple LEDs are utilized in the initial calibration that is later finetuned/recalibrated with the operational temperatures because (1) it is the application of a known technique to a known device/method ready for improvement to yield predictable results; and/or (2) the multiple LEDs utilized would provide a better/broader approximation of the LEDs reaction to temperature than the usage of a singular LED; and/or (3) the finetune/recalibration modality would not require as many measurements/computation at the time of use compared to only calibrating at the time of use; and/or (4) finetuning/recalibrating at the time of use would account for environmental differences between the approximated “factory” calibration compared to the usage calibration (see Meehan ¶[0025]); and/or (5) finetuning/recalibrating periodically as appropriate when changes occur would improve the accuracy of the measurements (see Meehan ¶[0030]). Here, the finetuning/recalibration of the modified Mah corresponds to the compensation of the present claim, specifically the “adjusting a calibration of the light emitting diode based on the operating temperature”.
Regarding Claim 4, Mah in view of Huiku and Meehan teaches the device of claim 1 as stated above. Mah further teaches to the circuitry is configured to determine the temperature for the light emitting diode based at least in part on the difference in voltage value, the population slope factor, and based further on a calibration temperature of the light emitting measured diode during a calibration process for the light emitting diode (¶[0082]-[0099] during the construction of the linear function, the temperatures used in the calibration regions for the function, the temperatures in the calibration region is the calibration temperature).
Regarding Claim 5, Mah in view of Huiku and Meehan teaches the device of claim 1 as stated above. Mah further teaches the circuitry is configured to determine the operating temperature for the light emitting diode based at least in part on the difference in voltage value, the population slope factor, and based further on a calibration difference in voltage value for the light emitting diode measured during a calibration process (¶[0082]-[0099] ¶[0082]-[0099] during the construction of the linear function, the different currents input used for the calibration would necessarily have a voltage, these during the calibration process would be considered the calibration different in voltage value).
Regarding Claim 13, Mah in view of Huiku and Meehan teaches the device of claim 1 as stated above. Mah further teaches to determine a second difference in voltage value for a second light emitting diode; and determine a second operating temperature for the second light emitting diode based on the second difference in voltage value, wherein the determination that the device is valid is further based on the second temperature for the second light emitting diode (see ¶[0080]-[0099], the temperature determination is described for a single light source, but is indicated as being performed on each light source, ¶[0030]-[0032] there are multiple light sources; Figs. 1-3A).
Regarding Claim 14, Mah in view of Huiku and Meehan teaches the device of claim 1 as stated above. The modified Mah teaches determine a second difference in voltage value for the light emitting diode between a third voltage at the light emitting diode at a third current and the first voltage; determine a difference in temperature value based on the second difference in voltage value; and determine an updated operating temperature for the light emitting diode based on the difference in temperature value (see Meehan ¶[0027] and ¶[0030], the system may recalibrate/fine-tune the LEDs via current operating parameters).
Alternatively and/or additionally, Huiku further teaches that the adjustment to the oxygen saturation measurement, including the temperature adjustment, but are updated several times during the in-vivo measurement process (see ¶[0228]-[0229]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the updating modality of Huiku with the temperature and oxygen saturation measurement of the modified Mah because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) updating the calibration and providing an updated oxygen saturation would increase the accuracy of the results, to further accommodate any changes in current/voltage.
Regarding Claim 15, Mah in view of Huiku and Meehan teaches the device of claim 14 as stated above. The modified Mah further teaches compensate for a second shift in wavelength due to the updated operating temperature; determine an updated oxygen saturation level based on the compensation for the second shift in wavelength; and output an indication of the updated oxygen saturation level (see Huiku ¶[0228]-[0229] the calibration and the oxygen saturation are updated several times during the in-vivo measurement process; see Mah ¶[0029] the computer 1 calculates and displays the concentration of the substance in question. Fig. 1; see Meehan ¶[0027] and ¶[0030], the system may recalibrate/fine-tune the LEDs via current operating parameters). Updating the calibration and updating the oxygen saturation based on the updated calibration is taught by the update/refinement of the modified Mah.
Regarding Claim 16, Mah in view of Huiku and Meehan teaches the device of claim 14 as stated above. Mah further teaches to determine the difference in temperature value, the circuitry is configured to multiply the second difference in voltage value with a factor indicating a change in temperature over a change in voltage for the light emitting diode (¶[0082]-[0099] the difference in the voltage drop ΔV between the two applied currents at the light source is utilized in the temperature determination, which then may be utilized during a calibration process to approximate a linear relationship, in which solving for the constants would yield an equation with a slope, because it is a linear relationship, which then is utilized for maintaining constant output intensity by monitoring temperature, the slope would be utilized to update the intensity/temperature as different currents are input).
Regarding Claim 22, Mah in view of Huiku and Meehan teaches the device of claim 1 as stated above. The modified Mah further teaches the population slope factor comprises a value defined outside of a manufacturing environment (see Meehan ¶[0027] and ¶[0030], the system may recalibrate/fine-tune the LEDs via current operating parameters). As the system is finetuned/recalibrated at time of use, the population slope factor includes a value defined outside of a manufacturing environment.
Regarding Claim 23, Mah in view of Huiku and Meehan teaches the device of claim 1 as stated above. Mah further teaches the circuitry is further configured to determine a temperature trend for the light emitting diode (¶[0099] and ¶[0103] the temperature is continuously/intermittently monitored, which corresponds to the temperature over time, which is a trend).
Regarding Claim 24, Mah in view of Huiku and Meehan teaches the method of claim 19 as stated above. Mah further teaches to track changes in the operating temperature over time. (¶[0099] and ¶[0103] the temperature is continuously/intermittently monitored, which corresponds to tracking changes to the temperature over time, as any changes would be able to be identified).
Regarding Claim 25, Mah in view of Huiku and Meehan teaches the system of claim 20 as stated above. Mah further teaches the circuitry is further configured to determine a temperature trend for the light emitting diode (¶[0099] and ¶[0103] the temperature is continuously/intermittently monitored, which corresponds to the temperature over time, which is a trend).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mah in view of Huiku and Meehan as applied to claim 1 above, and in view of Pauritsch et al. (US Patent Application Publication 2013/0336360 – cited in prior action), hereinafter Pauritsch.
Regarding Claim 12, Mah in view of Huiku teaches the device of claim 14 as stated above. Mah teaches to monitor temperature and keep the intensity constant in order to get analyte measurements (see ¶[0099]), but does not specifically teach to determine whether the device is valid based on the operating temperature, and wherein the determination of the oxygen saturation level is in response to the determination that the device is valid.
Pauritsch teaches an electronic circuit to monitor a temperature of a light emitting diode by monitoring a difference between a first and second voltage caused by a first and second current at the light emitting diode (see abstract and ¶[0031]-[0033]; Fig. 1), in which if the difference of the voltages ΔV is greater than a threshold Vfmax, then the LED is determined to be too hot, and the current is reduced and/or the LED is powered down in order to reduce the temperature of the LED.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the threshold too hot determination and power off of Pauritsch with the temperature and oxygen saturation measurement of the modified Mah because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) powering off the LEDs for a time would allow the LEDs temperature to reduce to an appropriate level for oxygen saturation measurement. Here, as the LEDs would be powered down if the temperature is too hot (i.e., the LED is not valid), the intensity determination would only occur if the LED data is valid, because otherwise the LED would be powered off.
Claims 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mah in view of Huiku and Meehan as applied to claim 14 above, and in view of Harper (WIPO Publication WO 2011/026053 – cited in prior action), hereinafter Harper.
Regarding Claim 18, Mah in view of Huiku and Meehan teaches the device of claim 14 as stated above. The modified Mah is silent regarding to initiate a timer in response to the determination of the operating temperature for the light emitting diode; and in response to determining that the timer has elapsed, determine the updated operating temperature.
Harper teaches systems/methods of an analyte monitoring device having a user interface for displaying values and alerts (see abstract), in which the time between calibrations of the analyte sensor is monitored, and once a predetermined time has elapsed, outputting an alarm/alert to inform the user it is time to recalibrate (see ¶[0108]-[0109]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to time monitoring recalibration of Berman with the temperature adjusted calibration of the modified Mah because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) periodically recalibrating would keep the results (i.e., the temperature and ultimately the oxygen saturation) accurate over time.
Regarding Claim 21, Mah in view of Huiku and Meehan teaches the device of claim 1 as stated above. The modified Mah is silent regarding that the circuitry is further configured to pause determining the oxygen saturation level while updating a measurement of the operating temperature of the light emitting diode.
Harper teaches systems/methods of an analyte monitoring device having a user interface for displaying values and alerts (see abstract), in which the time between calibrations of the analyte sensor is monitored, and once a predetermined time has elapsed, outputting an alarm/alert to inform the user it is time to recalibrate (see ¶[0108]-[0109]), and that measurement/reporting of analyte results is stopped (i.e., paused) until calibration has settled/finished (see ¶[0250]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to time monitoring recalibration of Berman with the temperature adjusted calibration of the modified Mah because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) periodically recalibrating would keep the results (i.e., the temperature and ultimately the oxygen saturation) accurate over time; and/or (3) it would not measure/display inaccurate results (see Harper ¶[0250]) which may confuse a patient or cause incorrect diagnosis/assistance via a medical professional.
Response to Arguments
Applicant’s arguments, claim objections
Applicant’s arguments, see pg. 9, filed November 11, 2025, with respect to the objections of claims 9, 14, 16, and 18 have been fully considered and are persuasive. Therefore, the objections have been withdrawn. However, upon further consideration, a new objection is made that was necessitated by Applicant’s amendment filed on November 11, 2025.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 9, filed November 11, 2025, with respect to the rejections of claims 1-19 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 101
Applicant’s arguments, see pg. 10-11, filed November 11, 2025, with respect to the rejections of claims 1-20 under 35 U.S.C. § 101 have been fully considered and are NOT persuasive. The Applicant first argues that, with regard to Step 2A, prong 1, the claim when taken as a whole is not directed towards a mathematical concept. The examiner respectfully disagrees. Under Step 2A, prong one, “Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim” (emphasis added). See MPEP 2106.04(II)(A)(1). The claim is not taken as a whole in Step 2A, prong 1; rather, the claim is evaluated to determine if a judicial exception (i.e., an abstract idea) is set forth or described in the claim. As recited above and discussed in the claim interpretation section, the claimed limitations include, under the BRI, mathematical calculations/evaluations. Therefore, Applicant’s arguments are not persuasive.
Next, the Applicant argues that the claim includes photonic signals and operating temperatures which rely on mathematical concepts; however, the claim as a whole is not directed to a mathematical concept and is eligible under Prong One. The examiner respectfully disagrees. The examiner maintains that the claims recite limitations that, when taken under the BRI in light of the specification as it would be interpreted by one of ordinary skill in the art, include mathematical calculations/evaluations. For example, the recitation “determine a difference in voltage value for a light emitting diode based on a first voltage at the light emitting diode at a first current and a second voltage at the light emitting diode at a second current, wherein the difference in voltage value is dependent on a temperature at the light emitting diode” (see specification ¶[0098]) is being interpreted as mathematical calculations/evaluations. The recitation “determine an operating temperature for the light emitting diode based at least in part on the difference in voltage value and a population slope factor” (see specification ¶[0100] and ¶[0102]-[0103]) is being interpreted as mathematical calculations/evaluations. The recitation “compensate for a shift in wavelength due to the operating temperature, comprising adjusting an estimated wavelength of the light emitting diode based on the operating temperature or adjusting a calibration of the light emitting diode based on the operating temperature” (see specification ¶[0101]-[0107]) is being interpreted as mathematical calculations/evaluations. The recitation “determine an oxygen saturation level based on the intensity signal and the adjusted estimated wavelength or the adjusted calibration” (see specification ¶[0064]-[0065]) is being interpreted as mathematical calculations/evaluations and/or judgements (i.e., comparisons and/or judgements to compare/identify the values in the table). Therefore, Applicant’s arguments are not persuasive.
Furthermore, while Applicant has not addressed this element of the rejection, the examiner maintains that the claims recite mental processes, i.e., the claimed limitations include, under the BRI, multiple evaluations and judgement. Therefore, even if the claimed elements were to be considered to be merely relying on mathematical concepts, the claims would still be rejected under 35 U.S.C. § 101 because the claims recite mental processes.
Next, the Applicant argues that under Step 2A, prong two, when considered as a whole, the claims provide a particular solution, that presents advantages in a specific technological field. The examiner respectfully disagrees. The Applicant has not specified any advantages/improvements of the claimed devices/method; however, based on the specification of the present application, the improvements lie in the temperature determination and oxygen saturation determination (see present application specification ¶[0037], ¶[0039], ¶[0099], ¶[0134], and ¶[0145]). Therefore, the improvement is directed towards the abstract ideas themselves (i.e., the improvement in the determination of the temperature and the oxygen saturation).
An improved mental process is still a mental process even if such a mental process results in more accurate results.1,2 Also, having the claims focus on determining the temperature and oxygen saturation is not itself limiting the claims to improving the technology because cases that involve practical, technological improvements extend beyond simply improving the accuracy of a prediction.3 See, e.g., McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299, 1315 (Fed. Cir. 2016) (“The claimed process uses a combined order of specific rules that renders information into a specific format that is then used and applied to create desired results: a sequence of synchronized, animated characters.”); Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1304 (Fed. Cir. 2018) (finding patent eligible a claim drawn to a behavior-based virus scan that protects against viruses that have been “cosmetically modified to avoid detection by code-matching virus scans”); Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1330, 1333 (Fed. Cir. 2016) (discussing patent eligible claims directed to “an innovative logical model for a computer database” that included a self-referential table allowing for greater flexibility in configuring databases, faster searching, and more effective storage); CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358, 1368 (Fed. Cir. 2020) (explaining that the claims at issue focus on a specific means for improving cardiac monitoring technology; they are not “directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery” (quoting McRO, 837 F.3d at 1314)). Therefore, Applicant’s arguments are not persuasive.
Next, the Applicant argues that the amended claims amount to significantly more than a mathematical formular, providing a technological improvement in medical device monitoring. The examiner respectfully disagrees. As explained above, the improvement does not lie in medical device monitoring; rather, based on the specification of the present application, the improvements lie in the temperature determination and oxygen saturation determination (see present application specification ¶[0037], ¶[0039], ¶[0099], ¶[0134], and ¶[0145]). Therefore, the improvement is directed towards the abstract ideas themselves (i.e., the improvement in the determination of the temperature and the oxygen saturation).
An improved mental process is still a mental process even if such a mental process results in more accurate results.4,5 Also, having the claims focus on determining the temperature and oxygen saturation is not itself limiting the claims to improving the technology because cases that involve practical, technological improvements extend beyond simply improving the accuracy of a prediction.6 See, e.g., McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299, 1315 (Fed. Cir. 2016) (“The claimed process uses a combined order of specific rules that renders information into a specific format that is then used and applied to create desired results: a sequence of synchronized, animated characters.”); Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1304 (Fed. Cir. 2018) (finding patent eligible a claim drawn to a behavior-based virus scan that protects against viruses that have been “cosmetically modified to avoid detection by code-matching virus scans”); Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1330, 1333 (Fed. Cir. 2016) (discussing patent eligible claims directed to “an innovative logical model for a computer database” that included a self-referential table allowing for greater flexibility in configuring databases, faster searching, and more effective storage); CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358, 1368 (Fed. Cir. 2020) (explaining that the claims at issue focus on a specific means for improving cardiac monitoring technology; they are not “directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery” (quoting McRO, 837 F.3d at 1314)). Therefore, Applicant’s arguments are not persuasive.
Next, the Applicant argues that ineligibility has not been established by a preponderance of the evidence here. The examiner respectfully disagrees. The Applicant has not explained why a preponderance of the evidence has not been established. The examiner maintains that the 35 U.S.C. § 101 rejection as recited above clears sets forth why the claims are rejected under 35 U.S.C. § 101 based on a preponderance of the evidence. Therefore, Applicant’s arguments are not persuasive. The examiner maintains the rejections to the claims under 35 U.S.C. § 101.
Applicant’s arguments, double patenting
Applicant’s arguments, see pg. 11-12, filed November 11, 2025, with respect to the rejections of claims 1-20 on the grounds of non-statutory double patenting have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Meehan et al. (US Patent Application Publication 2014/0275890 – cited by Applicant).
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 12-13, filed November 11, 2025, with respect to the rejections of claims 1-20 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Meehan et al. (US Patent Application Publication 2014/0275890 – cited by Applicant).
Allowable Subject Matter
Claims 2, 6, and 11 do not have prior art applied for the reasons of record as stated in the Non-Final Office Action mailed on August 11, 2025, but the claims are not in condition for allowance due to the rejections of the claims under 35 U.S.C. § 101.
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 JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER M. 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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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
1 “[T]he improvement in computational accuracy alleged here does not qualify as an improvement to a technological
process; rather, it is merely an enhancement to the abstract mathematical calculation of haplotype phase itself...The
different use of a mathematical calculation, even one that yields different or better results, does not render patent
eligible subject matter.” In re Board of Trustees of Leland Stanford Junior University, 991 F.3d 1245 (Fed. Cir.
2021).
2 “[A] claim for a new abstract idea is still an abstract idea.” Synopsys, Inc. v. Mentor Graphics Corp, 839 F.3d 1138
(Fec. Cir. 2016).
3 See In re Board of Trustees of Leland Stanford Junior University, 991 F.3d 1245 (Fed. Cir. 2021).
4 “[T]he improvement in computational accuracy alleged here does not qualify as an improvement to a technological
process; rather, it is merely an enhancement to the abstract mathematical calculation of haplotype phase itself...The
different use of a mathematical calculation, even one that yields different or better results, does not render patent
eligible subject matter.” In re Board of Trustees of Leland Stanford Junior University, 991 F.3d 1245 (Fed. Cir.
2021).
5 “[A] claim for a new abstract idea is still an abstract idea.” Synopsys, Inc. v. Mentor Graphics Corp, 839 F.3d 1138
(Fec. Cir. 2016).
6 See In re Board of Trustees of Leland Stanford Junior University, 991 F.3d 1245 (Fed. Cir. 2021).