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 .
Information Disclosure Statement
It is noted that the Information Disclosure Statement (IDS) submissions (see attachments) are extremely long, citing over 300 references for consideration. The Examiner has considered the references submitted as part of the Information Disclosure Statements, but has found the majority have no relevance to patentability. Applicants are encouraged to provide a concise explanation of the information if Applicants are aware of document(s) or a section of a document that is highly relevant to patentability. See MPEP 609.04(a)(III) and MPEP 2004.13:
Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the references have been considered in a cumulative manner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "2028" (in [0077] - [0078] (“computing circuit 2028”)) and "2048" (rest of the specification and Fig. 2) have both been used to designate “computing circuit”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because it includes a purported merit/speculative application of the invention including “For example, such an embodiment can determine the blood-oxygen level of the subject with little or no skin-tone bias”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure. A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 and Claim 18 are objected to because of the following informalities: regarding the term “redirected by the body portion”, it is suggested to revise the term to be “redirected by the exposed body portion” for consistency and readability in the claims. Appropriate correction is required.
Claim 15 and Claim 32 are objected to because of the following informalities: regarding the term “redirected by the skin”, it is suggested to revise the term to be “redirected by the exposed skin” for consistency and readability in the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4 – 5, 13 – 15, 32, and 35 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 2 (line 1) recites the limitation "the arterial-blood-saturation level SaO2". There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited arterial-blood-saturation level. For the purposes of examination, the term “the arterial-blood-saturation level SaO2” is deemed to claim “an arterial-blood-saturation level SaO2”.
Claim 4 (line 1), Claim 5 (line 1) each recite the limitation " wherein the computer circuit ". There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited computer circuit. It is unclear if this is intended to be the same or different than the previously-recited computing circuit. For the purposes of examination, the term “wherein the computer circuit” is deemed to claim “wherein the computing circuit”.
Claim 5 (lines 2 – 3) recites the term “determine the blood-oxygen level of the subject by selecting a blood-oxygen level from a look-up table in response to a respective characteristic of each of the signals.” As recited, it is unclear if the blood-oxygen level that is selected from the look-up table is the final determined blood-oxygen level of the subject, or if the blood-oxygen level from the look-up table is an intermediary reference value, from which the determined blood-oxygen level of the subject is separately determined. It is unclear if the blood-oxygen level from a look-up table is intended to be the same or different than the previously-recited blood-oxygen level. For the purposes of examination, the term “determine the blood-oxygen level of the subject by selecting a blood-oxygen level from a look-up table in response to a respective characteristic of each of the signals” is deemed to claim “determine the blood-oxygen level of the subject by selecting the blood-oxygen level from a look-up table correlating to a respective characteristic of each of the signals.”
Claim 13 (line 2) and Claim 14 (line 2) each recite the limitation "an indication of the skin color of the subject". There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited skin color. For the purposes of examination, the term “an indication of the skin color of the subject” is deemed to claim “an indication of a skin color of the subject”.
Claim 15 (line 4) recites the term “a spectrometer configured”. It is unclear if this is intended to be the same or different than the previously-recited spectrometer in Claim 1, from which this claim depends. For the purposes of examination, the term “a spectrometer configured” is deemed to claim “the spectrometer configured”.
Claim 15 (line 7) and Claim 32 (line 5) each recite the term “the received portion of the at least one other wavelength into at least one signal”. It is unclear if this is intended to be the same or different than the previously-recited at least one signal in Claim 1, from which this claim depends. For the purposes of examination, the term “the received portion of the at least one other wavelength into at least one signal” is deemed to claim “the received portion of the at least one other wavelength into at least one other signal”.
Claim 15 (line 8) recites the term “a computing circuit configured”. It is unclear if this is intended to be the same or different than the previously-recited computing circuit in Claim 1, from which this claim depends. For the purposes of examination, the term “a computing circuit configured” is deemed to claim “the computing circuit configured”.
Claim 15 (line 9) and Claim 32 (line 6) recites the term “a melanin level in the skin”. It is unclear if this is intended to be the same or different than the previously-recited exposed skin, or if this is an overall skin metric. For the purposes of examination, the term “a melanin level in the skin” is deemed to claim “a melanin level in the exposed skin of the subject”.
Claim 15 (line 9) Claim 32 (line 6) each recite the term “in response to the at least one signal”. It is unclear if this at least one signal is intended to be the same or different than the at least one signal in Claim 1 (or Claim 18) or the at least one signal in Claim 15 (or Claim 32). For the purposes of examination, and based on the interpretation above, the term “in response to the at least one signal” is deemed to claim “in response to the at least one other signal.”
Claim 35 (line 1 and 2) recites the term “irradiating an exposed body portion of a subject”. It is unclear if these are intended to be the same or different body portion and subject as previously-recited. For the purposes of examination, the term ”irradiating an exposed body portion of a subject” is deemed to claim “irradiating the exposed body portion of the subject”.
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 – 18, 21, 23 – 24, and 32 - 35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claims recites an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 18, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 18, 21, 23 – 24, and 32 - 35 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 18, 21, 23 – 24, and 32 - 35 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 18, 21, 23 – 24, and 32 - 35 recites an abstract idea.
Specifically, Independent Claims 1 and 18 recite (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim
An apparatus, comprising:
at least one electromagnetic-energy source that is configured to emit more than two wavelengths toward an exposed body portion of a subject;
a spectrometer configured
to receive a portion of the more than two wavelengths redirected by the body portion, and
to convert the received portion into signals each representing a respective group of at least one of the more than two wavelengths; and
a computing circuit configured to determine a blood-oxygen level of the subject in response to the signals.
Claim 18
A method, comprising:
irradiating an exposed body portion of a subject with more than two wavelengths of electromagnetic energy simultaneously;
receiving a portion of the more than two wavelengths redirected by the body portion;
converting the received portion into signals each representing a respective group of at least one of the more than two wavelengths; and
determining a blood-oxygen level of the subject in response to the signals.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1 and 18, these limitations include:
Observation and judgment to convert the received portion into signals each representing a respective group of at least one of the more than two wavelengths
Observation and judgment of a blood-oxygen level of the subject in response to the signals.
Similarly, the Dependent Claims include the following abstract limitations, in addition to the aforementioned limitations in Independent Claims 1 and 18 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
execute a machine-learning model
Observation and judgment to execute a machine-learning model
determine the blood-oxygen level of the subject in response to a respective characteristic of each of the signals.
Observation and judgment of the blood-oxygen level of the subject in response to a respective characteristic of each of the signals.
determine the blood-oxygen level of the subject by selecting a blood-oxygen level from a look-up table in response to a respective characteristic of each of the signals.
Observation and judgment of the blood-oxygen level of the subject by selecting a blood-oxygen level from a look-up table in response to a respective characteristic of each of the signals.
determine the blood-oxygen level of the subject in response to a skin color of the subject.
Observation and judgment of the blood-oxygen level of the subject in response to a skin color of the subject.
adjust the determined blood-oxygen level of the subject in response to a skin color of the subject.
Observation and judgment to adjust the determined blood-oxygen level of the subject in response to a skin color of the subject.
select, in response to a skin color of the subject, a machine-learning model from multiple machine-learning models
Observation and judgment to select, in response to a skin color of the subject, a machine-learning model from multiple machine-learning models
determine the blood-oxygen level of the subject in response to the selected machine-learning model.
Observation and judgment of the blood-oxygen level of the subject in response to the selected machine-learning model.
select, in response to a skin color of the subject, a look-up table from multiple look-up tables;
Observation and judgment to select, in response to a skin color of the subject, a look-up table from multiple look-up tables;
determine the blood-oxygen level of the subject in response to the selected look-up table.
Observation and judgment of the blood-oxygen level of the subject in response to the selected look-up table.
adjust the determined blood-oxygen level of the subject in response to the selected look-up table.
Observation and judgment to adjust the determined blood-oxygen level of the subject in response to the selected look-up table.
receive an indication of the skin color of the subject
Observation and judgment of an indication of the skin color of the subject
determine the blood-oxygen level of the subject in response to the indication of the skin color of the subject.
Observation and judgment of the blood-oxygen level of the subject in response to the indication of the skin color of the subject.
adjust the determined blood-oxygen level of the subject in response to the indication of the skin color of the subject.
Observation and judgment to adjust the determined blood-oxygen level of the subject in response to the indication of the skin color of the subject.
convert the received portion of the at least one other wavelength into at least one signal
Observation and judgment to convert the received portion of the at least one other wavelength into at least one signal
determine a melanin level in the skin in response to the at least one signal,
Observation and judgment of a melanin level in the skin in response to the at least one signal,
determine the blood-oxygen level of the subject in response to the determined melanin level.
Observation and judgment of the blood-oxygen level of the subject in response to the determined melanin level.
determine the blood-oxygen level of the subject by mathematically combining blood-oxygen levels calculated by the selected machine-learning models.
Observation and judgment of the blood-oxygen level of the subject by mathematically combining blood-oxygen levels calculated by the selected machine-learning models.
determine the blood-oxygen level of the subject by taking a weighted average of blood-oxygen levels calculated by the selected machine-learning models.
Observation and judgment of the blood-oxygen level of the subject by evaluating a weighted average of blood-oxygen levels calculated by the selected machine-learning models.
determining the blood-oxygen level of the subject includes determining the blood-oxygen level of the subject in response to a melanin level in skin of the subject.
Observation and judgment of the blood-oxygen level of the subject includes Observation and judgment of the blood-oxygen level of the subject in response to a melanin level in skin of the subject.
adjusting the determined blood- oxygen level of the subject in response to a melanin level in skin of the subject.
Observation and judgment to adjust the determined blood- oxygen level of the subject in response to a melanin level in skin of the subject.
all of which are grouped as mental processes or mathematical algorithms under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1 and 18 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 1 – 18), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source”
“spectrometer”
“computing circuit”/”computer circuit”
“look-up table”/”multiple look-up tables”
“machine-learning model”/”multiple machine-learning models”
Additional elements recited include “at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source”, “spectrometer”, “computing circuit”/”computer circuit”, “look-up table”/”multiple look-up tables”, “machine-learning model”/”multiple machine-learning models” in Independent Claims 1 and 18 (and their respective Dependent Claims). These components are recited at a high level of generality, i.e., as a computing circuit performing a generic function of processing data (the determining); These generic hardware component limitations “at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source”, “spectrometer”, “computing circuit”/”computer circuit”, “look-up table”/”multiple look-up tables”, “machine-learning model”/”multiple machine-learning models” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Claims 1 – 18, 21, 23 – 24, and 32 - 35 includes pre-solution activity limitations, such as:
at least one electromagnetic-energy source that is configured to emit more than two wavelengths toward an exposed body portion of a subject;
a spectrometer configured to receive a portion of the more than two wavelengths redirected by the body portion
wherein the blood-oxygen level is an estimate of the arterial-blood-saturation level SaO2 of the subject.
wherein the blood-oxygen level is an SpO2 of the subject.
at least one other electromagnetic-signal source that is configured to emit at least one other wavelength toward exposed skin of the subject;
a spectrometer configured to receive a portion of the at least one other wavelength redirected by the skin,
irradiating an exposed body portion of a subject with more than two wavelengths of electromagnetic energy simultaneously;
receiving a portion of the more than two wavelengths redirected by the body portion;
irradiating exposed skin of the subject with at least one other wavelength of electromagnetic energy;
receiving a portion of the at least one other wavelength redirected by the skin;
irradiating an exposed body portion of a subject includes irradiating an exposed body portion of a subject with more than eight wavelengths of electromagnetic energy simultaneously.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source”, “spectrometer”, “computing circuit”/”computer circuit”, “look-up table”/”multiple look-up tables”, “machine-learning model”/”multiple machine-learning models” as recited in Independent Claims 1 and 18 (and their respective Dependent Claims) are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 1 and 18 (and their dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 1 and 18 (and their dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1 and 18 (and their dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 18, 21, 23 – 24, and 32 - 35 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source”, “spectrometer”, “computing circuit”/”computer circuit”, “look-up table”/”multiple look-up tables”, “machine-learning model”/”multiple machine-learning models” as recited in Independent Claim 1 (and their dependent claims).
The additional elements of the “at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source”, “spectrometer”, “computing circuit”/”computer circuit”, “look-up table”/”multiple look-up tables”, “machine-learning model”/”multiple machine-learning models” in Independent Claims 1 and 18 (and their dependent claims), as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source” is described generically at [0336] as a “broadband-spectrum (e.g., white) LED.” The “at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source” is shown as LEDs 6000-6012 in Figs. 2 and 6.
Per Applicant’s specification, the “spectrometer” is described generically at [0085] as “ The spectrometer 2026 can be an off-the-shelf spectrometer and is configured to separate the tissue-redirected electromagnetic energy collected by the one or more collector optical fibers of the probe 2002 into ranges of wavelengths…” The “spectrometer” is shown as generic box element “Spectrometer 2026” in Fig. 2.
Per Applicant’s specification, the “computing circuit”/”computer circuit” is described generically at [0086] with “…the computing circuit 2048…can include a respective one or more of a microprocessor, microcontroller, and a field-programmable gate array (FPGA), or the computing circuit and controller can be disposed on a same set of one or more of a microprocessor, microcontroller, and an FPGA…computing circuit 2048 can be configured to execute an algorithm…” The “computing circuit”/”computer circuit” is shown as generic box element “Computing Circuit 2048” in Fig. 2.
Per Applicant’s specification, the “look-up table”/”multiple look-up tables” is described generically at [0301] as “the conventional pulse oximeter uses the value of the ratio (1) as an address for a look-up table (LUT) onboard the pulse oximeter…” The ““look-up table”/”multiple look-up tables” are not shown in a figure.
Per Applicant’s specification, the “machine-learning model”/”multiple machine-learning models” is described generically in alternative with other algorithmic options at [0155] with “Examples of suitable mathematical algorithms include learning algorithms (e.g., machine-learning and statistical-learning algorithms) such as locally weighted regression (LWR) models (see, for example, col. 9, lines 25 – 32 of U.S. Patent 10,463,286), support vector machines, decision-tree methods (e.g., random forest, XGBoost), neural networks (NN) (e.g., feed forward, convolutional (CNN), recurrent, generative adversarial), and recommender systems.”
Accordingly, in light of Applicant’s specification, the claimed terms “at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source”, “spectrometer”, “computing circuit”/”computer circuit”, “look-up table”/”multiple look-up tables”, “machine-learning model”/”multiple machine-learning models” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for “at least one electromagnetic-energy source”/”at least one other electromagnetic-signal source”, “spectrometer”, “computing circuit”/”computer circuit”, “look-up table”/”multiple look-up tables”, “machine-learning model”/”multiple machine-learning models.” This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Independent Claims 1 and 18 (and their dependent claims) amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and apparatus of Claims 1 – 18, 21, 23 – 24, and 32 - 35 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 18, 21, 23 – 24, and 32 - 35 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claims 1 and 18 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 – 18, 21, 23 – 24, and 32 - 35 apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 – 18, 21, 23 – 24, and 32 - 35 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 18, 21, 23 – 24, and 32 - 35 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 6 – 8, 11 – 14, 16, 18, 21, 23, 24, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arakaki et. al., (US 2022/0333986 A1).
Regarding Claims 1 and 18, Arakaki discloses
For Claim 1: An apparatus ([Abstract]), comprising: at least one electromagnetic-energy source that is configured to emit more than two wavelengths toward an exposed body portion of a subject ([0143] “the tissue (e.g., skeletal-muscle tissue) illuminated by the generated electromagnetic energy per step 5016.”; [0151] “the control circuit 2028…activate the LEDs corresponding to all groups of illuminator optical fibers simultaneously…”; Fig. 6, “LED 6000”; [0066] “electromagnetic-energy generator 2022…generate a spectrum of wavelengths of electromagnetic energy…an LED configured to emit white light… the wavelength(s) of the emitted blue light and the wavelength(s) of the phosphoresced yellow light…)(Examiner notes that that more than one wavelength of blue light and more than one wavelength of yellow light, per the (s), would be more than two wavelengths emitted (at least 4).);
a spectrometer ([0064] " spectrometer 2026…”) configured
For Claim 18: A method ([Abstract]; [0003]), comprising:
irradiating an exposed body portion of a subject with more than two wavelengths of electromagnetic energy simultaneously ([0143] “the tissue (e.g., skeletal-muscle tissue) illuminated by the
generated electromagnetic energy per step 5016.”; [0151] “the control circuit 2028…activate the LEDs corresponding to all groups of illuminator optical fibers simultaneously…”; Fig. 6, “LED 6000”; [0066] “electromagnetic-energy generator 2022…generate a spectrum of wavelengths of electromagnetic energy…an LED configured to emit white light… the wavelength(s) of the emitted blue light and the wavelength(s) of the phosphoresced yellow light…)(Examiner notes that that more than one wavelength of blue light and more than one wavelength of yellow light, per the (s), would be more than two wavelengths emitted (at least 4).);
For both Claims 1 and 18, Arakaki discloses:
to receive a portion of the more than two wavelengths redirected by the body portion ([0072] “ spectrometer 2026 can be an off-the-shelf spectrometer and is configured to separate the tissue-redirected electromagnetic energy collected by the one or more collector optical fibers of the probe 2002 into ranges of wavelengths…“), and
to convert the received portion into signals each representing a respective group of at least one of the more than two wavelengths ([0072] “…separate the tissue-redirected electromagnetic energy collected by the one or more collector optical fibers of the probe 2002 into ranges of wavelengths and to generate, for each wavelength range, at least one signal having…a characteristic of the wavelengths in the range.”); and
a computing circuit ([0072] “ control circuit 2028 for processing…”) configured to determine a blood-oxygen level of the subject in response to the signals ([0072]; [0073] “computing circuit 2048…determine, in response to the one or more signals from the spectrometer 2026, a cell-oxygen-saturation level of one or more cells in tissue of a subject…”)
Regarding Claim 4, Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 4, Arakaki discloses wherein the computer circuit is configured to execute a machine-learning model that determines the blood-oxygen level of the subject in response to a respective characteristic of each of the signals ([0073] “computing circuit 2048 can be configured to execute an algorithm, such as a machine-learning algorithm, to determine, in response to the one or more signals from the spectrometer 2026, a cell-oxygen-saturation level of one or more cells in tissue of a subject illuminated by the probe head 2010.”).
Regarding Claim 6, Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 6, Arakaki discloses wherein the computing circuit is configured to determine the blood-oxygen level of the subject in response to a skin color of the subject ([0151] “because melanin can impede diffusion of electromagnetic energy in tissue (particularly through the skin), the control circuit 2028 can be configured to control the electromagnetic- energy generator 2022 so that the intensity of the generated electromagnetic energy increases as the darkness of a subject's skin increases and decreases as the darkness of a subject's skin decreases…”; [0073] “computing circuit 2048…execute an algorithm, such as a machine-learning algorithm…determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject….”)(Examiner notes that the lighting is controlled based on the darkness of the subject’s skin, which overall broadly results in a determination of the blood-oxygen level of the subject in response to the change in lighting conditions based on the skin color of the subject.).
Regarding Claim 7, Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 7, Arakaki discloses wherein the computing circuit is configured to adjust the determined blood-oxygen level of the subject in response to a skin color of the subject ([0151] “because melanin can impede diffusion of electromagnetic energy in tissue (particularly through the skin), the control circuit 2028 can be configured to control the electromagnetic- energy generator 2022 so that the intensity of the generated electromagnetic energy increases as the darkness of a subject's skin increases and decreases as the darkness of a subject's skin decreases…”; [0073] “computing circuit 2048…execute an algorithm, such as a machine-learning algorithm…determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject….”)(Examiner notes that the lighting is controlled and adjusted based on the darkness of the subject’s skin, which overall broadly results in an adjustment of the blood-oxygen level of the subject in response to the change in lighting conditions based on the skin color of the subject relative to what the determination would be without adjusting the lighting for skin tone).
Regarding Claim 8, Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 8, Arakaki discloses wherein the computing circuit ([0073] “computing circuit 2048 can be configured to execute an algorithm…”) is configured:
to select, in response to a skin color of the subject, a machine-learning model from multiple machine-learning models ([0234] “…train multiple algorithm models…For example, there can be a respective model for each skin tone as defined by Fitzpatrick skin type…”, “…user can select the best model for a particular subject…”); and
to determine the blood-oxygen level of the subject in response to the selected machine-learning model ([0234] “…user can select the best model for a particular subject…”; [0073] “computing circuit 2048 can be configured to execute an algorithm, such as a machine-learning algorithm, to determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject…”).
Regarding Claim 11, Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 11, Arakaki discloses wherein the computing circuit ([0073] “computing circuit 2048 can be configured to execute an algorithm…”) is configured:
to determine a skin color of the subject ([0151] “…the darkness of a subject's skin…”; [0202] “training data…skin color (hereinafter “skin tone”…Fitzpatrick scale…”; 0234] “…train multiple algorithm models…For example, there can be a respective model for each skin tone as defined by Fitzpatrick skin type…”, “…user can select the best model for a particular subject…”); and
to determine the blood-oxygen level of the subject in response to the determined skin color of the subject ([0151] “because melanin can impede diffusion of electromagnetic energy in tissue (particularly through the skin), the control circuit 2028 can be configured to control the electromagnetic- energy generator 2022 so that the intensity of the generated electromagnetic energy increases as the darkness of a subject's skin increases and decreases as the darkness of a subject's skin decreases…”; ([0234] “…user can select the best model for a particular subject…”; [0073] “computing circuit 2048 can be configured to execute an algorithm, such as a machine-learning algorithm, to determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject…”)( Examiner notes that the lighting is controlled and adjusted based on the darkness of the subject’s skin (a broad indication of the skin color of the subject), which overall broadly results in determination of the blood-oxygen level of the subject in response to the change in lighting conditions based on the skin color of the subject relative to what the determination would be without adjusting the lighting for skin tone).
Regarding Claim 12, Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 12, Arakaki discloses wherein the computing circuit ([0073] “computing circuit 2048 can be configured to execute an algorithm…”) is configured:
to determine a skin color of the subject ([0151] “…the darkness of a subject's skin…”; [0202] “training data…skin color (hereinafter “skin tone”…Fitzpatrick scale…”; 0234] “…train multiple algorithm models…For example, there can be a respective model for each skin tone as defined by Fitzpatrick skin type…”, “…user can select the best model for a particular subject…”); and
to adjust the determined blood-oxygen level of the subject in response to the determined skin color of the subject ([0151] “because melanin can impede diffusion of electromagnetic energy in tissue (particularly through the skin)…control circuit 2028…control the electromagnetic- energy generator 2022…intensity of the generated electromagnetic energy increases as the darkness of a subject's skin increases and decreases as the darkness of a subject's skin decreases…”; ([0234] “…user can select the best model for a particular subject…”; [0073] “computing circuit 2048 can be configured to execute an algorithm, such as a machine-learning algorithm, to determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject…”)( Examiner notes that the lighting is controlled and adjusted based on the darkness of the subject’s skin (a broad indication of the skin color of the subject), which overall broadly results in adjusting of the blood-oxygen level of the subject in response to the change in lighting conditions based on the skin color of the subject relative to what the determination would be without adjusting the lighting for skin tone).
Regarding Claim 13, Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 13, Arakaki discloses wherein the computing circuit ([0073] “computing circuit 2048 can be configured to execute an algorithm…”) is configured:
to receive an indication of the skin color of the subject ([0151] “…the darkness of a subject's skin…”; [0202] “training data…skin color (hereinafter “skin tone”…Fitzpatrick scale…”; 0234] “…train multiple algorithm models…For example, there can be a respective model for each skin tone as defined by Fitzpatrick skin type…”, “…user can select the best model for a particular subject…”); and
to determine the blood-oxygen level of the subject in response to the indication of the skin color of the subject ([0151] “because melanin can impede diffusion of electromagnetic energy in tissue (particularly through the skin)…control circuit 2028…control the electromagnetic- energy generator 2022…intensity of the generated electromagnetic energy increases as the darkness of a subject's skin increases and decreases as the darkness of a subject's skin decreases…”; ([0234] “…user can select the best model for a particular subject…”; [0073] “computing circuit 2048 can be configured to execute an algorithm, such as a machine-learning algorithm, to determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject…”)(Examiner notes that the lighting is controlled and adjusted based on the darkness of the subject’s skin (a broad indication of the skin color of the subject), which overall broadly results in determination of the blood-oxygen level of the subject in response to the change in lighting conditions based on the skin color of the subject relative to what the determination would be without adjusting the lighting for skin tone).
Regarding Claim 14, Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 14, Arakaki discloses wherein the computing circuit ([0073] “computing circuit 2048 can be configured to execute an algorithm…”) is configured:
to receive an indication of the skin color of the subject ([0151] “…the darkness of a subject's skin…”; [0202] “training data…skin color (hereinafter “skin tone”…Fitzpatrick scale…”; 0234] “…train multiple algorithm models…For example, there can be a respective model for each skin tone as defined by Fitzpatrick skin type…”, “…user can select the best model for a particular subject…”); and
to adjust the determined blood-oxygen level of the subject in response to the indication of the skin color of the subject ([0151] “because melanin can impede diffusion of electromagnetic energy in tissue (particularly through the skin)…control circuit 2028…control the electromagnetic- energy generator 2022…intensity of the generated electromagnetic energy increases as the darkness of a subject's skin increases and decreases as the darkness of a subject's skin decreases…”; ([0234] “…user can select the best model for a particular subject…”; [0073] “computing circuit 2048 can be configured to execute an algorithm, such as a machine-learning algorithm, to determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject…”)(Examiner notes that the lighting is controlled and adjusted based on the darkness of the subject’s skin (a broad indication of the skin color of the subject), which overall broadly results in adjusting of the blood-oxygen level of the subject in response to the change in lighting conditions based on the skin color of the subject relative to what the determination would be without adjusting the lighting for skin tone).
Regarding Claims 16 and 33, Arakaki discloses as described above, The apparatus of claim 1 and The method of claim 18, respectively. For the remainder of Claims 16 and 33, Arakaki discloses wherein the computing circuit ([0073] “computing circuit 2048 can be configured to execute an algorithm…”) is configured:
to select, in response to a skin color of the subject, machine-learning models ([0234] “…train multiple algorithm models…For example, there can be a respective model for each skin tone as defined by Fitzpatrick skin type…”, “…user can select the best model for a particular subject…”); and
to determine the blood-oxygen level of the subject by mathematically combining blood-oxygen levels calculated by the selected machine-learning models (Fig. 5, Step 5020 “Determines the patient’s…cell oxygenation level…”; [0143] “the determined level of cell-oxygenation may be, effectively, an average, or other mathematical combination, of the respective cell-oxygen-saturation levels of the cells that form the tissue….”; [0140] “…at a step 5020…”; [0142] “…computing circuit 2048 processes the values…applying these values as inputs to a mathematical algorithm that the computing circuit executes…suitable mathematical algorithms include learning algorithms (e.g., machine-learning…”; [0151] “the control circuit 2028 can repeat the steps 5016, 5018, 5020, and 5022 multiple times…”)
Regarding Claim 21, Arakaki discloses as described above, The method of claim 18. For the remainder of Claim 21, Arakaki discloses wherein determining the blood-oxygen level of the subject includes determining the blood-oxygen level in response to a machine-learning model (Fig. 5, Step 5020 “Determines the patient’s…cell oxygenation level”; [0140] “…at a step 5020…”; [0142] “…computing circuit 2048 processes the values…applying these values as inputs to a mathematical algorithm that the computing circuit executes…suitable mathematical algorithms include learning algorithms (e.g., machine-learning…”)
Regarding Claim 23, Arakaki discloses as described above, The method of claim 18. For the remainder of Claim 23, Arakaki discloses wherein determining the blood-oxygen level of the subject includes determining the blood-oxygen level of the subject in response to a melanin level in skin of the subject ([0151] “because melanin can impede diffusion of electromagnetic energy in tissue (particularly through the skin)…control circuit 2028…control the electromagnetic- energy generator 2022…intensity of the generated electromagnetic energy increases as the darkness of a subject's skin increases and decreases as the darkness of a subject's skin decreases…”; ([0234] “…user can select the best model for a particular subject…”; [0073] “computing circuit 2048 can be configured to execute an algorithm, such as a machine-learning algorithm, to determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject…”)(Examiner notes that the melanin level is relative increased when the skin is darker, and the lighting is controlled and adjusted based on the darkness of the subject’s skin (a broad indication of a qualitative melanin level in the skin of the subject), which overall broadly results in determination of the blood-oxygen level of the subject in response to the change in lighting conditions based on the melanin level of the subject relative to what the determination would be without adjusting the lighting for skin tone).
Regarding Claim 24, Arakaki discloses as described above, The method of claim 18. For the remainder of Claim 24, Arakaki discloses further comprising adjusting the determined blood- oxygen level of the subject in response to a melanin level in skin of the subject ([0151] “because melanin can impede diffusion of electromagnetic energy in tissue (particularly through the skin)…control circuit 2028…control the electromagnetic- energy generator 2022…intensity of the generated electromagnetic energy increases as the darkness of a subject's skin increases and decreases as the darkness of a subject's skin decreases…”; ([0234] “…user can select the best model for a particular subject…”; [0073] “computing circuit 2048 can be configured to execute an algorithm, such as a machine-learning algorithm, to determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject…”)(Examiner notes that the melanin level is relative increased when the skin is darker, and the lighting is controlled and adjusted based on the darkness of the subject’s skin (a broad indication of a qualitative melanin level in the skin of the subject), which overall broadly results in adjustment of the blood-oxygen level of the subject in response to the change in lighting conditions based on the melanin level of the subject relative to what the determination would be without adjusting the lighting for skin tone).
Claims 1 – 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Putcha et. al., (US 2026/0026718).
Regarding Claim 1, Putcha discloses An apparatus, comprising:
at least one electromagnetic-energy source that is configured to emit more than two wavelengths toward an exposed body portion of a subject ([0087] “There are six LEDs, two for each wavelength (red,
IR, and UV-A)… three photodiodes, one for each wavelength.”; Fig. 7, “LEDs”)(Examiner notes that the electromagnetic-energy source can broadly be collectively all of the LEDs together.);
a spectrometer ([0080] “Because our device uses reflectance spectrometry…”; [0104] “we made use of the Ocean XR2 Spectrometer to measure the transmission of red and infrared light through samples of melanated tissue”) configured
to receive a portion of the more than two wavelengths redirected by the body portion ([0080] “our device uses reflectance spectrometry…the amount of light reflected from the tissue…”; [0088] “light is shown through the glass vial, and a spectrometer absorbs light from the other side.”; Fig. 7, “Photodiodes”)(Examiner notes that blood in the glass vial is human tissue and is broadly a body portion from a human specimen.), and
to convert the received portion into signals each representing a respective group of at least one of the more than two wavelengths (Fig 10, “1000, Detect, using first sensor, first measurement indicative of melanin concentration in a portion of skin of a subject” and “1002, Detect, using second sensor, second measurement indicative of light absorbed by melanin and arterial blood of subject”; “first and second measurements”)(Examiner notes that the signals are grouped according to melanin concentration determination use or arterial blood oxygenation determination use.); and
a computing circuit configured to determine a blood-oxygen level of the subject in response to the signals (Fig. 9; [0090] “blood oxygen saturation percentage measurement generator 910…produces a blood oxygen saturation percentage measurement that is adjusted based on the melanin concentration measured by melanin concentration sensor 906.”; Fig. 10, “1004, Generate, based on first and second measurements, third measurement…percentage of oxygen saturation of arterial blood of subject”)
Regarding Claim 2, Putcha discloses as described above, The apparatus of claim 1. For the remainder of Claim 2, Putcha discloses wherein the blood-oxygen level is an estimate of the arterial-blood-saturation level SaO2 of the subject (Fig. 9; [0090] “blood oxygen saturation percentage measurement generator 910…produces a blood oxygen saturation percentage measurement that is adjusted based on the melanin concentration measured by melanin concentration sensor 906.”; [0045] “SpO2 estimation vs melanin concentration (mg/mL)…”; Fig. 12)(Examiner notes that Applicant describes in the specification at [0013] that “Said another way, SpO2 is a noninvasive estimate of the arterial blood saturation SaO2 of a patient/subject.”, such that measuring SpO2 is an estimate of the arterial-blood-saturation level SaO2 of the subject.)
Regarding Claim 3, Putcha discloses as described above, The apparatus of claim 1. For the remainder of Claim 3, Putcha discloses wherein the blood-oxygen level is an SpO2 of the subject (Fig. 9; [0090] “blood oxygen saturation percentage measurement generator 910…produces a blood oxygen saturation percentage measurement that is adjusted based on the melanin concentration measured by melanin concentration sensor 906.”; [0045] “SpO2 estimation vs melanin concentration (mg/mL)…”; Fig. 12).
Claims 18 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bechtel et. al., (US 2017/0303861 A1).
Regarding Claim 18, Bechtel discloses A method ([Abstract]; [0008]; Fig. 4), comprising:
irradiating an exposed body portion of a subject with more than two wavelengths of electromagnetic energy simultaneously ([0096] “four different wavelengths that may be generated and emitted by each source structure…”; [0065] “…source structures 120a – 120b”; Figure 2; Fig. 4 “Emitted light enters the tissue from one or more sources…”);;
receiving a portion of the more than two wavelengths redirected by the body portion ([0182] “number of the detector structures receives the light subsequent to transmission through or reflectance from the first tissue….”);
converting the received portion into signals each representing a respective group of at least one of the more than two wavelengths ([01823] – [0184] “The oximeter probe there after determines a melanin compensation component (e.g., an angle correction (such as θ1, θ2, φ1, φ2, Δθ, Δφ, or any combination of these)”); and
determining a blood-oxygen level of the subject in response to the signals (Fig. 4; [0185] “The oximeter probe uses the melanin compensation component to obtain a melanin-corrected oxygen saturation value for the first tissue.”; [0060] “Oximeter probe 101 includes display 115, a processor 116…”; [0087] “…processor uses the baseline measurement for melanin content for the healthy contralateral tissues tissue to adjust the oxygen saturation values of the target tissue”; [0186] “…determining, by a processor of the oximeter probe…oxygen saturation…”).
Regarding Claim 32, Bechtel discloses as described above, The method of claim 18. For the remainder of Claim 32, Bechtel discloses further comprising:
irradiating exposed skin of the subject with at least one other wavelength of electromagnetic energy ([0096] “four different wavelengths that may be generated and emitted by each source structure…”; [0065] “…source structures 120a – 120b”; Figure 2)(Examiner notes that if three of the “four different wavelengths” are the more than two wavelengths of Claim 18, then the fourth of the “four different wavelengths” is broadly the at least one other wavelength of electromagnetic energy.);
receiving a portion of the at least one other wavelength redirected by the skin ([0182] “number of the detector structures receives the light subsequent to transmission through or reflectance from the first tissue….”); and
converting the received portion of the at least one other wavelength into at least one signal ([01823] – [0184] “The oximeter probe there after determines a melanin compensation component (e.g., an angle correction (such as θ1, θ2, φ1, φ2, Δθ, Δφ, or any combination of these)”);
determining a melanin level in the skin in response to the at least one signal ([0081] “the oximeter probe determines the value for the melanin content.”); and
wherein determining the blood-oxygen level of the subject includes determining the blood-oxygen level in response to the determined melanin level (Fig 4; [0185] “The oximeter probe uses the melanin compensation component to obtain a melanin-corrected oxygen saturation value for the first tissue.”; [0082] - [0086] “the processor generates oxygen saturation values for target tissue using the oximetry measurements….uses the baseline measurement for melanin content…to adjust the oxygen saturation values of the target tissue…”)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bechtel et. al., (US 2017/0303861 A1) in view of Arakaki et. al., (US 2022/0333986 A1).
Regarding Claim 1, Bechtel discloses An apparatus ([Abstract]), comprising:
at least one electromagnetic-energy source that is configured to emit more than two wavelengths toward an exposed body portion of a subject ([0096] “four different wavelengths that may be generated and emitted by each source structure…”; [0065] “…source structures 120a – 120b”; Figure 2);
to receive a portion of the more than two wavelengths redirected by the body portion ([0182] “number of the detector structures receives the light subsequent to transmission through or reflectance from the first tissue….”), and
to convert the received portion into signals each representing a respective group of at least one of the more than two wavelengths ([01823] – [0184] “The oximeter probe there after determines a melanin compensation component (e.g., an angle correction (such as θ1, θ2, φ1, φ2, Δθ, Δφ, or any combination of these)”); and
a computing circuit configured to determine a blood-oxygen level of the subject in response to the signals (Fig. 4; [0185] “The oximeter probe uses the melanin compensation component to obtain a melanin-corrected oxygen saturation value for the first tissue.”; [0060] “Oximeter probe 101 includes display 115, a processor 116…”; [0087] “…processor uses the baseline measurement for melanin content for the healthy contralateral tissues tissue to adjust the oxygen saturation values of the target tissue”; [0186] “…determining, by a processor of the oximeter probe…oxygen saturation…”).
Bechtel does not specifically disclose a spectrometer. Bechtel broadly discloses that[0053] “The detectors can be photodetectors, photoresistors, or other types of detectors”.
Arakaki teaches a system for determining and monitoring a level of oxygenation in tissue of a body, including spectrometer that “can include a photo detector”, such as a probe with “spectrometer 2026”. ([Abstract]; [0080] Fig. 4, [0060]). Specifically for Claim 1, Arakaki teaches a spectrometer (Fig. 4, [0064] “spectrometer 2026”; [0107] “ provide collected electromagnetic energy to the spectrometer 2026…where each of one or more of a second set of the collector cores is configured to provide…light reflected from the body part to a detection circuit (e.g., photodetector) onboard the base 2004”)
Bechtel is open to combine with a spectrometer type of detector with [Bechtel: 0053] with “Each detector structure includes one or more detectors…The detectors can be photodetectors, photoresistors, or other types of detectors.” Arakaki provides a motivation to combine at [0103] with “ the spectrometer 2026 spatially separates the wavelengths of the redirected electromagnetic energy into ranges…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using a spectrometer with a photodetector would be useful to separate the wavelengths of light from the skin as a viable option to enhance the quality of results for the photodetector relative to the skin.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the probe with a photodetector “or other type of detectors” disclosed by Bechtel with the spectrometer for the detector taught by Arakaki, creating a single oxygen saturation measurement apparatus to measure oxygen saturation using reflected light from the skin and a spectrometer for separating wavelengths.
Regarding Claim 5, Bechtel in view of Arakaki discloses The apparatus of claim 1. For the remainder of Claim 5, Bechtel discloses wherein the computer circuit ([0127] “processor 116…”) is configured to determine the blood-oxygen level of the subject by selecting a blood-oxygen level from a look-up table in response to a respective characteristic of each of the signals ([0127] “ a look-up table of oxygen saturation values is generated for finding the best fit of the absorption coefficients μa to the oxygen saturation…look-up table…generated by assuming a range of likely…melanin…unit vector is compared to the look-up table to find the best fit…gives the oxygen saturation”.)
Regarding Claim 15, Bechtel in view of Arakaki discloses The apparatus of claim 1 and a spectrometer (See citations above). For the remainder of Claim 15, Bechtel discloses The apparatus of claim 1, further comprising:
at least one other electromagnetic-signal source that is configured to emit at least one other wavelength toward exposed skin of the subject ([0096] “four different wavelengths that may be generated and emitted by each source structure…”; [0065] “…source structures 120a – 120b”; Figure 2)(Examiner notes that if three of the “four different wavelengths” are the more than two wavelengths of Claim 18, then the fourth of the “four different wavelengths” is broadly the at least one other wavelength of electromagnetic energy.);
to receive a portion of the at least one other wavelength redirected by the skin ([0182] “number of the detector structures receives the light subsequent to transmission through or reflectance from the first tissue….”), and
to convert the received portion of the at least one other wavelength into at least one signal ([01823] – [0184] “The oximeter probe there after determines a melanin compensation component (e.g., an angle correction (such as θ1, θ2, φ1, φ2, Δθ, Δφ, or any combination of these)”); and
a computing circuit ([0127] “processor 116…”) configured
to determine a melanin level in the skin in response to the at least one signal ([0081] “the oximeter probe determines the value for the melanin content.”), and
to determine the blood-oxygen level of the subject in response to the determined melanin level (Fig 4; [0185] “The oximeter probe uses the melanin compensation component to obtain a melanin-corrected oxygen saturation value for the first tissue.”; [0082] - [0086] “the processor generates oxygen saturation values for target tissue using the oximetry measurements….uses the baseline measurement for melanin content…to adjust the oxygen saturation values of the target tissue…”).
The combination of the spectrometer as used in Claim 15 is the same as that described in more detail above in Claim 1. Looking to the 112(b) interpretation above, it is interpreted to be the same spectrometer as recited in claim 1. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the probe with a photodetector “or other type of detectors” disclosed by Bechtel with the spectrometer for the detector taught by Arakaki, creating a single oxygen saturation measurement apparatus to measure oxygen saturation using reflected light from the skin and a spectrometer for separating wavelengths.
Claims 9 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bechtel in view of Arakaki, further in view of Mannheimer et. al., (US 20140343375 A1).
Regarding Claim 9, Bechtel in view of Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 9, Bechtel discloses wherein the computing circuit ([0127] “processor 116…”) is configured:
to select, in response to a skin color of the subject, a look-up table ([0127] “a look-up table of oxygen saturation values is generated for finding the best fit of the absorption coefficients…to the oxygen saturation. The look-up table may be generated by assuming a range of likely total hemoglobin, melanin, and oxygen saturation values and calculating μa for each of these scenarios.”)
and to determine the blood-oxygen level of the subject in response to the selected look-up table ([0127] “Then the unit vector is compared to the look-up table to find the best fit, which gives the oxygen
saturation.”).
Bechtel does not specifically disclose from multiple look-up tables. Bechtel does generate the look-up table from “assuming a range of likely total hemoglobin, melanin, and oxygen saturation values”, and there are broadly theoretically multiple look-up tables that could be generated from range assumptions.
Mannheimer teaches to select, in response to a skin color of the subject, a look-up table from multiple look-up tables ([0062] “…look-up tables 314 and 316…look-up table 314 to determine appropriate wavelength dependent coefficients for the oxygen calculation…”; [0085] “Pigment adjustment feature”, “a sensitivity index, indicating how large an adjustment in readings should be made as a function of skin color.”);
Bechtel and Mannheimer both disclose and teach look-up tables for determining wavelength-dependent coefficients for oxygen saturation calculations, Bechtel performing it with a single generated look-up table (Bechtel: 0127]) and Mannheimer with a set of two look-up tables (Mannheimer: 0062]) Mannheimer provides a motivation to combine at [0062] with “One value is provided to a look-up table 314 to determine appropriate wavelength dependent coefficients for the oxygen calculation. The other value(s) are then provided to another look up table(s) 316 which provides input (e.g., coefficients) to other calculations performed by controller 318. These additional calculations may enhance the performance and/or safety of the system.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using multiple look-up tables that can be chosen for a particular purposes would be useful for calculating an oxygen saturation, as well as using the results to increase the performance of the system.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Bechtel’s disclosed generated look-up table of absorption coefficients from melanin values to calculate oxygen saturation with the concept of using multiple look-up tables for oxygen saturation calculation taught by Mannheimer, creating a single oxygen saturation measurement apparatus that can determine oxygen saturation from a particular look-up table and increase performance of the system.
Regarding Claim 10, Bechtel in view of Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claim 10, Bechtel discloses wherein the computing circuit ([0127] “processor 116…”) is configured:
to select, in response to a skin color of the subject, a look-up table ([0127] “a look-up table of oxygen saturation values is generated for finding the best fit of the absorption coefficients…to the oxygen saturation. The look-up table may be generated by assuming a range of likely total hemoglobin, melanin, and oxygen saturation values and calculating μa for each of these scenarios.”)
to adjust the determined blood-oxygen level of the subject in response to the selected look-up table ([0127] “Then the unit vector is compared to the look-up table to find the best fit, which gives the oxygen saturation.”; Fig. 4: “adjusts a determined oxygen saturation value using the value the melanin content…”)
Bechtel does not specifically disclose from multiple look-up tables. Bechtel does generate the look-up table from “assuming a range of likely total hemoglobin, melanin, and oxygen saturation values”, and there are broadly theoretically multiple look-up tables that could be generated from range assumptions.
Mannheimer teaches to select, in response to a skin color of the subject, a look-up table from multiple look-up tables ([0062] “…look-up tables 314 and 316…look-up table 314 to determine appropriate wavelength dependent coefficients for the oxygen calculation…”; [0085] “Pigment adjustment feature”, “a sensitivity index, indicating how large an adjustment in readings should be made as a function of skin color.”);
The motivation to combine Bechtel with Mannheimer in Claim 10 is the same as that described in more detail above for Claim 9. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Bechtel’s disclosed generated look-up table of absorption coefficients from melanin values to calculate oxygen saturation with the concept of using multiple look-up tables for oxygen saturation calculation taught by Mannheimer, creating a single oxygen saturation measurement apparatus that can determine oxygen saturation from a particular look-up table and increase performance of the system.
Claims 17 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Arakaki et. al., (US 2022/0333986 A1) in view of Watson et. al., (US 2010/0016690 A1).
Regarding Claims 17 and 34, Arakaki discloses as described above, The apparatus of claim 1. For the remainder of Claims 17 and 34, Arakaki discloses
wherein the computing circuit ([0073] “computing circuit 2048 can be configured to execute an algorithm…”) is configured:
to select, in response to a skin color of the subject, machine-learning models ([0234] “…train multiple algorithm models…For example, there can be a respective model for each skin tone as defined by Fitzpatrick skin type…”; “…user can select the best model for a particular subject…”); and
to determine the blood-oxygen level of the subject taking an average of blood-oxygen levels calculated by the selected machine-learning models (Fig. 5, [0234] “…user can select the best model for a particular subject…”; [0073] “computing circuit 2048 can be configured to execute an algorithm, such as a machine-learning algorithm, to determine…a cell-oxygen-saturation level of one or more cells in tissue of a subject…”; [0151] “the control circuit 2028 can repeat the steps 5016, 5018, 5020, and 5022 multiple times…can generate the displayed
value of cell-oxygen-saturation level as the average, or other mathematical combination, of the values of the cell-oxygen saturation levels determined over update windows”).
Arakaki does not specifically disclose a weighted average of blood-oxygen levels calculated by the selected machine-learning models.
Watson teaches techniques to determine oxygen saturation results from spectral PPG signals, including finding multiple oxygen saturation measurements and performing a weighted average of results for an “optimal oxygen saturation” [Abstract; 0081]. Specifically for claims 17 and 34, Watson teaches to determine the blood-oxygen level of the subject by taking a weighted average of blood-oxygen levels calculated by the multiple methods ([0081] “SpO2 processor 508 may calculate one oxygen saturation from the coefficients received from wavelet processor 504…separately calculate another oxygen saturation from the coefficients received from spectral processor 506…optimal oxygen saturation may be combined by using an average or a weighted average of the two oxygen saturation calculations.“)
Arakaki and Watson both disclose and teach making multiple determinations of oxygen saturation and averaging them for a final value: Arakaki with [Arakaki: 0151] “value of cell-oxygen-saturation level as the average, or other mathematical combination, of the values of the cell-oxygen saturation levels determined over update windows” and Watson with the “average or a weighted average” of two oxygen saturation calculations. Watson provides a motivation to combine at [Watson: 0081] with “The two oxygen saturation calculations may then be combined to generate an optimal oxygen saturation. The optimal oxygen saturation may be combined by using an average or a weighted average of the two oxygen saturation calculations.“ A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that calculating an oxygen saturation multiple ways, such as by using different inputs or different algorithms, then taking a weighted average would be useful for obtaining a more accurate oxygen saturation result.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “average, or other mathematical combination, of the values of the cell-oxygen saturation levels” for display as the calculated oxygen saturation value disclosed in Arakaki with the specific weighted average mathematical combination of oxygen saturation values taught by Watson, creating a single oxygen saturation measurement apparatus that provides a more accurate oxygen saturation result by using a weight average of multiple oxygen saturation results.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Arakaki in view of Choi et. al., (US 2021/0059585 A1).
Regarding Claim 35, Arakaki discloses as described above, The method of claim 18. For the remainder of Claim 35, Arakaki discloses wherein irradiating an exposed body portion of a subject includes irradiating an exposed body portion of a subject with more than three wavelengths of electromagnetic energy simultaneously ([0143] “the tissue (e.g., skeletal-muscle tissue) illuminated by the generated electromagnetic energy per step 5016.”; [0151] “the control circuit 2028…activate the LEDs corresponding to all groups of illuminator optical fibers simultaneously…”; Fig. 6, “LED 6000”; [0066] “electromagnetic-energy generator 2022…generate a spectrum of wavelengths of electromagnetic energy…an LED configured to emit white light… the wavelength(s) of the emitted blue light and the wavelength(s) of the phosphoresced yellow light…)(Examiner notes that that more than one wavelength of blue light and more than one wavelength of yellow light, per the (s), would be more than two wavelengths emitted (at least 4).);
Arakaki does not specifically disclose more than eight wavelengths of electromagnetic energy simultaneously. Arakaki does broadly disclose that the generator could include a “broadband source”, but does not specify that it is specifically providing more than eight wavelengths.
Choi teaches a multi-wavelength biological sensing device that uses a broadband light source and detects PPG signals at 15 wavelengths to increase the accuracy of the result for subjects with different skin colors ([Abstract], [0010]; [0045] Fig. 1C). Specifically for Claim 35, Choi teaches irradiating an exposed body portion of a subject with more than eight wavelengths of electromagnetic energy simultaneously (Fig. 1C; [0045] “to provide a large number of PPG signals at different wavelengths, only one broad spectrum light-emitting diode (LED) or a few LEDs covering broad spectrum are required….”; [0048] “…made a chip-scale integrated MW-PPG sensing device to synchronously detect MW-PPG signals at 15 wavelengths, including: 505 nm, 510 nm, 515 nm, 520 nm, 525 nm, 620 nm, 625 nm, 630 nm, 635 nm, 640 nm, 930 nm, 935 nm, 940 nm, 945 nm, and 950 nm.”).
Choi provides a motivation to combine at [0010] “it has been noted that PPG sensing light sources at different wavelengths are recommended for the subjects with different skin colors. In applying multi-wavelength photoplethysmography (MW-PPG) sensing technology, the most suitable wavelength can be chosen to pick the PPG signals of best quality. This can effectively improve the accuracy of heart rate sensing by 15%.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using a broad-spectrum light that can provide at least 15 detected wavelengths would be useful for picking the best-quality signals for the PPG measurement relative to different skin colors for enhanced measurement accuracy.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Arakaki’s disclosed multiple wavelength light source to illuminate skin for wavelength measurement of oxygen concentration with Choi specific broad spectrum light that provides at least 15 detected wavelengths for PPG sensing, creating a single oxygen saturation measurement apparatus that can use multi-wavelength light source to choose the best quality signal to improve the accuracy of the sensor for a variety of persons with varying skin colors.
Conclusion
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/JUSTIN XU/
Primary Examiner, Art Unit 3791
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