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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 12th, 2025 has been entered. Claims 1-4, 7-21, and 23-29 remain pending in the application.
Response to Arguments
Applicant's arguments filed September 12th, 2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
At page 10, Applicant argues that the limitation of “causing the pulse oximeter to exclude pulse oximetry measurements that are taken when the material disposed within the pulse oximeter is identified to be other than tissue” provides an improvement and is not directed to a mathematical relationship or a mental process. Examiner respectfully disagrees. “It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility.” MPEP 2106 II. In light of Applicant’s specification, the claim encompasses photodetector values with as few as two photodetector values or a ratio of two photodetector values. See, for example, [0082-0084]. “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.” MPEP 2106.04(a)(2) III. The claimed steps can be performed using two photodetector values or a ratio of photodetector values in the human mind or by using a pen and paper. Furthermore, the improvement cannot be found in the abstract idea itself. “[I]t is important to keep in mind that an improvement in the abstract idea itself ... is not an improvement in technology.” MPEP 2106.05(a) Il. The claims recite steps for an analysis of data. The claims do not integrate the analysis into a practical application. Rather, the alleged improvement lies solely within the processing steps performed by the non-volatile logic. “Merely adding generic computer components to perform the steps is not sufficient. Thus, the claim must include more than mere instructions to perform the steps on a generic component or machinery to qualify as an improvement to an existing technology." Id. The claimed system invokes a computer as a tool to perform a mathematical concept and/or mental process. The light source, first photodetector, second photodetector, non-volatile logic, and substrate having an analog front-end perform the same with or without the claimed abstract idea. Therefore, it is unclear how the abstract idea can improve the standard functions of the additional elements. Additionally, it seems as if Applicant is arguing more than what is actually being claimed. The claims do not have any limitations drawn to saving battery power.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre- AJA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The limitations are interpreted as follows:
a. Claim 20: means for storing a plurality of characteristic signals - non-volatile memory in paragraphs [0017, 0092-0093] of the published specification
b. Claim 20: means for transmitting light- light emitting diode 260; a green light emitting diode in paragraphs [0044, 0047-0048] of the published specification
c. Claim 20: first means for detecting scattered light- photodetector 250, 230 are photodiodes or phototransistors in paragraphs [0044, 0047-0048] of the published specification
d. Claim 20: second means for detecting second scattered light — photodetector 250, 230 are photodiodes or phototransistors in paragraphs [0045, 0048-0049] of the published specification
e. Claim 20: means for calculating a ratio- program instructions executable by a computer, processor, computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays, rack-mounted computer, desktop computer, laptop computer, a laptop computer, a personal digital assistant, a smartphone, a mobile phone, an iPad in paragraphs [0092-0093, 0098-0099]] of the published specification
f. Claim 20: means for excluding undesirable materials - program instructions executable by a computer, processor, computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays, rack-mounted computer, desktop computer, laptop computer, a laptop computer, a personal digital assistant, a smartphone, a mobile phone, an iPad in paragraphs [0092-0093, 0098-0099]] of the published specification
g. Claim 20: means for identifying a characteristic signal- program instructions executable by a computer, processor, computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays, rack-mounted computer, desktop computer, laptop computer, a laptop computer, a personal digital assistant, a smartphone, a mobile phone, an iPad in paragraphs [0092-0093, 0098-0099]] of the published specification
h. Claim 20: means for identifying a material- program instructions executable by a computer, processor, computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays, rack-mounted computer, desktop computer, laptop computer, a laptop computer, a personal digital assistant, a smartphone, a mobile phone, an iPad in paragraphs [0092-0093, 0098-0099]] of the published specification
i. Claim 20: means for interfacing analog circuitry to digital circuitry - sensitive analog amplifiers, operational amplifiers, filters, and application-specific integrated circuits as needed to interface with sensors in paragraphs [0062, 0069-0070].
j. Claim 21: means for looking up values - program instructions executable by a computer, processor, computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays, rack-mounted computer, desktop computer, laptop computer, a laptop computer, a personal digital assistant, a smartphone, a mobile phone, an iPad in paragraphs [0092-0093, 0098-0099]] of the published specification.
Claim 20: means for causing the pulse oximeter to exclude pulse oximetry measurements - program instructions executable by a computer, processor, computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays, rack-mounted computer, desktop computer, laptop computer, a laptop computer, a personal digital assistant, a smartphone, a mobile phone, an iPad in paragraphs [0092-0093, 0098-0099]] of the published specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Specification
The amendment filed September 12th, 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “exclude measurements of undesired materials from oximetry measurements by a pulse oximeter”. The specification as originally filed at the time of the effective filing date discloses, in para. [0004-0006, 0035-0041], a pulse oximeter and that SpO2 is calculated/output but does not relate the photodetector values for material identification/discrimination to the SpO2calculation. The specification as originally filed at the time of the effective filing date additionally discloses, in para. [0082-0084], material identification from characteristic signals and excluding undesired materials but does not relate the material identification or exclusion of undesired materials to the calculation or SpO2 or calculation of oximetry measurements. Furthermore, the term “oximetry measurements” is not explicitly recited in specification as originally filed at the time of the effective filing date.
The specification is suggested to recite “exclude undesirable materials”, “excluding signals of undesired materials”, or “excluding photodetector measurements of undesired materials”.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-4, 7-21, and 23-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 (claims 2-4, 7-8, 23-29 by virtue of dependency), 9 (claims 10-19 by virtue of dependency), & 20 claim 21 by virtue of dependency) recites “cause/causing the pulse oximeter to exclude pulse oximetry measurements that are taken when the material disposed within the pulse oximeter is identified to be other than tissue”. The specification as originally filed at the time of the effective filing date does disclose in para. [0083-0084] excluding undesirable materials/excluding signals from the photodetectors of undesired materials. However, the specification as originally filed at the time of the effective filing date fails to adequately disclose excluding pulse oximetry measurements which would occur after processing of the photodetector signals to obtain pulse oximetry measurements.
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 1-4, 7-21, and 23-29 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 lines 25-26, claim 9 lines 26-27, & claim 20 lines 20-21 (claims 2-4, 7-8, 10-19, 21, 23-29 by virtue of dependency) recite the limitation “cause the pulse oximeter to exclude pulse oximetry pulse oximetry measurements”. It is unclear if the pulse oximetry measurements are supposed to refer to the first and second signals of the photodetectors or if the pulse oximetry measurements are referring to a measurement different from the first and second signals of the photodetectors. Furthermore, if the pulse oximetry measurements are referring to a measurement different from the signals, it is unclear how pulse oximetry measurements can be excluded when they have not previously been obtained/calculated.
Claim 1 line 26, claim 9 lines 26-27, & claim 20 lines 20-21 (claims 2-4, 7-8, 10-19, 21, 23-29 by virtue of dependency) recites “the material … is identified to be other than tissue”. It is unclear if the material identified to be other than tissue is supposed to refer to the undesirable materials to be excluded or another material in addition to the undesirable materials to be excluded. The limitation is suggested to recite “the material … is identified to be the undesirable materials”.
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 1-4, 7-21, and 23-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-4, 7-21, and 23-29 are all within at least one of the four categories.
Independent claims 1, 9, and 20 recites:
receive a first signal from the first photodetector, the first signal indicative of the scattered light;
receive a second signal from the second photodetector, the second signal indicative of the second scattered light;
calculate a ratio of the first signal and the second signal by dividing one of the first signal or the second signal by another one of the first signal or the second signal;
exclude signals of undesirable materials using only the ratio, while using at least one of the first signal and the second signal as a tie-breaker when a ratio value is common to at least two different materials;
identify, based on the first signal, the second signal, and the ratio, a characteristic signal from the plurality of characteristic signals;
identify, based on the characteristic signal, the material; and
cause the pulse oximeter to exclude pulse oximetry measurements that are taken when the material disposed within the pulse oximeter is identified to be other than tissue.
The above claim limitations (calculat[ing], identify[ing], exclud[ing]) constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of calculat[ing] recite a mathematical concept (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “calculate a ratio” in independent claims 1, 9, and 20 recites a mathematical relationship to determine a characteristic ratio of a material.
Referring to para. [0084] of the specification, a ratio of PD2/PD1 for each material is calculated and gives rise to a characteristic signal for each material that can be used to exclude undesired materials.
The claimed steps of calculat[ing], identify[ing], exclud[ing] can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for identifying a material that includes calculat[ing], identify[ing], exclud[ing].
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data gathering/output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Claims 2-4, 7-8, 11-12, and 23 are directed to light emitting diodes, opaque barriers, photodetectors, and analog front-ends for data-gathering that are well-understood, routine, conventional, and previously known to the pertinent industry.
Claims 10, 13-14, 15-19, and 24-28 are directed to more abstract ideas and further limitations on abstract ideas is already recited.
Claim 29 is directed to additional data gathering/output that is well-understood, routine and previously known to the industry.
This judicial exception (abstract idea) in Claims 1-4, 7-21, and 23-29 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for calculat[ing], identify[ing], exclud[ing], merely invoke a computer as a tool.
The data-gathering step (storing, emitting, receiving) and the data-output step do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for calculat[ing], identify[ing], exclud[ing].
The claims do not apply the abstract idea to affect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to identify a material.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for calculat[ing], identify[ing], exclud[ing]. The claims do not apply the obtained calculation to a particular machine. Rather, the data is merely output in a post-solution step.
The additional elements are identified as follows: pulse oximeter; light source/light emitting diode; memory; photodetector; non-volatile logic; analog front-end; substrate;
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g., para. [0092-0095]) which discloses the memory and processor comprises generic computer components that are configured to perform the generic computer functions (e.g., calculat[ing], identify[ing], exclud[ing]) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Applicant’s Background in the specification;
The non-patent literature of record in the application:
Texas Instruments, “Miniaturized Pulse Oximeter Reference Design”, TIDA-00311 datasheet, June 2014;
Analog Devices, “ADI Typical Module in Patient Monitor Pulse Oximeter Solution”, November 2011, www.analog.com/media/cn/technical-documentation/apm-pdf/adi-spo2_solutions_en.pdf;
Analog Devices, “20 μA Maximum, Rail-to-Rail I/O, Zero Input Crossover Distortion Amplifiers”, AD8505/AD8506/AD8508 datasheet, 2007;
Osram Opto Semiconductors, "SFH 7050 - Photoplethysmography Sensor", SFH 7050 datasheet, June 2014
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e., the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations 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 or improves any other technology. Their collective functions merely provide conventional computer implementation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Camacho (US 20020169379 A1) directed to a probe operative in the mid- or near-IR region of the EM for in situ sensing of the absorption of infrared energy or reflected infrared energy for distinguishing between two materials that have different infrared spectra and discloses comparing at least one of peak height, peak area, frequency and chemometric parameters or comparing at least one of the ratio for at least one of peak heights, peak area, frequencies and chemometrics for one or both materials (para. [0069-0070]).
Stover (US 6122047 A) directed to methods and apparatus for identifying the material of a particle occurring on the surface of a substrate discloses in col. 4 line 49- col. 5 line 13 & col. 9 lines 20-41 that correlations based on the back/forward ratio can sometimes converge for two or more materials and a second material-discriminating parameter is calculated as a ratio of the magnitude of the back-scatter signal to the magnitude of the center-scatter signal. The particle material is determined based on both the correlation of particle material with the magnitudes of the back-scatter signal and the back/forward ratio and a second correlation of particle material with the magnitudes of the back-scatter signal and the back/center ratio.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/CHARLES A MARMOR II/ Supervisory Patent Examiner, Art Unit 3791
/A.E.H./Examiner, Art Unit 3791