DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Applicant’s amendments and arguments filed September 8, 2025 with regards to the prior art are persuasive. After further review of the claims the following 112a and 101 rejections are being applied.
Response to Amendment
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-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
-In claim 1: ‘means for delivering the emitted light’ interpreted to have the structure of an optical probe with collection fibers as in claims 8-10 and equivalents thereof.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-‘sensing member’ in claims 20 and 45 interpreted to have the structure as disclosed in claims 21 and 46 and equivalents thereof.
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.
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.
Claims 1-23, 26-48, 51-62 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. Regarding claims 1, 28, and 53: here, the claim recites machine learning, deeper learning, or artificial intelligence (AI) approaches, but the specification never discloses the necessary steps and/or flowcharts of how any of these occurs. The terms “machine learning, deeper learning, or artificial intelligence (AI) approaches are treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. For example, how many and what types of layers are there? How is the data propagated? What logics are programmed to help the algorithms make a decision? Is the training supervised or unsupervised? What are the weightings? Are other training concepts used? It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
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 1-23, 26-48, 51-62 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding Step 1, claims 1-23, 26-48, 51-62 are all within at least one of the four categories (claims 28-48 and 51-52 being methods and claims 1-23, 26-27, and 53-62 being apparatuses).
Regarding Step 2, the independent claim 1 recites:
process the plurality of Raman spectra so as to identify spectral features from the plurality of Raman spectra,
assess the systemic hydration from the spectral features, and
analyze changes associated with hydration level using,
wherein the analyzing the changes utilizes generalized linear models (GLM) that incorporates results from the plurality of Raman spectra and participant factors including body mass index (BMI), age and temperature, wherein the GLM is governed by a linear equation: Y=pX + E, wherein Y is a vector containing a dependent variable of the plurality of Raman spectra, Xis a matrix containing independent variables of BMI, age and temperature, p is a vector containing weight coefficients of the independent variables, and E is a residual error in the GLM, wherein the weight coefficients are chosen using a linear least squares regression such that E is minimized.
Independent claim 28 recites:
identifying spectral features from the plurality of Raman spectra;
determining the systemic hydration from the spectral features; and
analyzing changes associated with hydration level using multivariate statistical, machine learning, deep learning or artificial intelligence (AI) approaches, wherein the analyzing the changes is performed with generalized linear models (GLM) that incorporates results from the plurality of Raman spectra and participant factors including body mass index (BMI), age and temperature, wherein the GLM is governed by a linear equation: Y = pX + E, wherein Y is a vector containing a dependent variable of the plurality of Raman spectra, X is a matrix containing independent variables of BMI, age and temperature, p is a vector containing weight coefficients of the independent variables, and E is a residual error in the GLM, wherein the weight coefficients are chosen using a linear least squares regression such that E is minimized
independent claim 53 recites:
process the signals
to determine the systemic hydration of the subject in real time, and
analyze changes associated with hydration level using multivariate statistical, machine learning, deep learning or artificial intelligence (AI) approaches,
wherein the analyzing the changes utilizes generalized linear models (GLM) that incorporates results from the plurality of Raman spectra and participant factors including body mass index (BMI), age and temperature, wherein the GLM is governed by a linear equation: Y =pX+ E, wherein Y is a vector containing a dependent variable of the plurality of Raman spectra, X is a matrix containing independent variables of BMI, age and temperature, p is a vector containing weight coefficients of the independent variables, and E is a residual error in the GLM, wherein the weight coefficients are chosen using a linear least squares regression such that E is minimized.
The above claim limitations are tied to the abstract idea of mental processes in that they are concepts that can be performed in the human mind and towards mathematical concepts in that they are mathematical relationships, formulas, equations, and/or calculations. This group encompasses concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
The claimed steps of process, assess, analyze, identifying, determining, analyzing, determine 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.
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.
Examples of ineligible claims that recite mathematical relationships include:
“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 m., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018) (performing a resampled statistical analysis to generate a resampled distribution).
Regarding Step 2A (prong 2):
This judicial exceptions (abstract ideas) in claims 1-23, 26-48, 51-62 are 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 process, assess, analyze, identifying, determining, analyzing, determine merely invoke a computer as a tool.
•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 process, assess, analyze, identifying, determining, analyzing, determine.
•The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide a medical measurement.
•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 process, assess, analyze, identifying, determining, analyzing, determine. The light source, detector and associated structures are merely used for extra-solutionary data gathering necessary to perform the abstract idea.
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.
Regarding Step 2B:
The additional elements are identified as follows: ‘a light source configured to operably emit light’ in claim 1, ‘means for delivering light to a target site to excite’ in claim 1, ‘collecting Raman scattering light’ in claim 1, ‘a detector…for obtaining a plurality of Raman spectra’ in claim 1, ‘a controller’ in claim 1, ‘multivariate statistical, machine learning, deep learning or artificial intelligence (AI) approaches’ in claim 1, ‘a dual wavelength laser module’ in claim 2, ‘an optical probe’ in claims 8-19, ‘a spectrograph’ in claim 20, ‘a sensing member’ in claims 20-21, ‘exciting a target site’ in claim 28, ‘collecting Raman scattering light’ in claim 28, ‘obtaining a plurality of Raman spectra’ in claim 28, ‘multivariate statistical, machine learning, deep learning or artificial intelligence (AI) approaches’ in claim 28, ‘an optical probe’ in claim 33-44, ‘a detector’ in claim 45, ‘a spectrograph’ in claim 45, ‘a sensing member’ in claims 45-46, ‘a light source configured to emit light’ in claim 53, ‘a filter’ in claim 53, 58, ‘a detector…to detect signals’ in claim 53 and 57, 59, ‘a controller…to operate’ in claim 53, ‘multivariate statistical, machine learning, deep learning or artificial intelligence (AI) approaches’ in claim 53, ‘dichroic mirrors’ in claim 55, ‘an alert’ in claim 56, ‘wearable and portable’ in claim 62.
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
The prior art provided by the Applicant in the IDS and by the Examiner in PTO-892 which disclose each of the elements as being known and conventional in the art elements;
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)(ll) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The light source, detector, filter, and associated structures (whether further limited in dependent claims) are only used for data gathering. 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 integrate a judicial exception into a practical application or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). See MPEP 2106.05(b).
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry or 3) further recite additional elements at a high level of generality which are conventional in the art.
Claims 2-21, 29-47, 54-62 recites additional elements at a high level of generality which are conventional in the art used for data gathering
Claims 22-23, 26-27, 48, 51-52 are steps that are also abstract as a mental process through additional data gathering or analysis
Claim 56 is extra-solutionary data output
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.
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791