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 .
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 10-15 and 18 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.
The subject matter which was not described in the specification is constructing a feature vector that includes a frequency domain representation of the heart rate signal and classifying that feature vector using machine learning to quantify a change in hydration, in combination with the other steps in the claims. While the applicant/inventors had a general idea of performing this activity, they did not possess the details of how the idea is carried out using a frequency domain representation and the specifics of exactly how the feature vector includes a frequency domain representation of heart rate signals and what exactly is done with the frequency domain feature vector to determine hydration.
In addition, the subject matter which was not described in the specification is classifying the feature vector into a class selected from a group consisting of hydrated, dehydrated by one percent and dehydrated by two percent, in combination with the other steps in the claims. While the applicant/inventors had a general idea of performing this activity, they did not possess the details of how the idea is carried out and the specifics of exactly how they determine if a patient is dehydrated by 1% and 2%.
In both of the above instances, the disclosure briefly mentions the claimed functions/limitations (repeats what is listed in the claims), but goes no further in describing how the claimed functions are used to quantify a change in hydration.
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 10-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the mental concept of receiving heart rate data, extracting features of the data to construct a feature vector, determining posture change and quantifying a change in hydration based on the posture change. This judicial exception is not integrated into a practical application because the combination of additional elements fails to integrate the judicial exception into a practical application. The claim is directed to an abstract idea with additional generic computer elements (e.g. a signal processor, etc.) that do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The data gathering step of using a heart rate sensor does not add a meaningful limitation as it is insignificant extra-solution activity. In addition, the heart rate sensor is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product to a particular technological environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, the additional elements (e.g. signal processor, heart rate sensor, etc.) do not add significantly more to the exception. The processor only calculates data while the heart rate sensor is directed to a data gathering step and these are well-understood, routine, conventional computer functions as recognized by the court decisions in MPEP 2106.05..
The claims are directed to an abstract idea and/or the end result of the system/method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer performing a calculation. The claims are directed to an abstract idea, i.e. implementing the idea of receiving heart rate data, extracting features of the data to construct a feature vector, determining posture change and quantifying a change in hydration based on the posture change, such as may be done by a mental process, critical thinking, and/or paper and pencil, or done by a mathematical equation, with additional generic computer elements, or additional structure (e.g. signal processor, heart rate sensor etc.) recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. The data gathering step of using a heart rate sensor does not add a meaningful limitation as it is insignificant extra-solution activity. In addition, the heart rate sensor is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product to a particular technological environment. These additional elements are well‐understood, routine and conventional limitations (see cited document(s)) that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims (e.g. claims 10 and 16 having a signal processor and heart rate sensor) is a method having a processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The data gathering step of using a heart rate sensor does not add a meaningful limitation as it is insignificant extra-solution activity. In addition, the heart rate sensor is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product to a particular technological environment. The claims also do not impose any limits on how the computations are accomplished, and thus it can be performed in any way known to those of ordinary skill in the art.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The processor and sensor are recited so generically (no details whatsoever are provided other than that they are a sensor and processor) that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification.
The limitations of the claims are carried out by the processor and the sensor, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/hydration status. The data gathering step of using a heart rate sensor does not add a meaningful limitation as it is insignificant extra-solution activity. In addition, the heart rate sensor is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product to a particular technological environment. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity. Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes (e.g., the mental computation of receiving heart rate data, extracting features of the data to construct a feature vector, determining posture change and quantifying a change in hydration based on the posture change, etc.), using the computer components as a tool. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 10-12 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Russell (9220444) in view of Selvaraj (10582862) . Russell discloses using a heart rate sensor to measure a heart rate of the subject before and after a posture change (e.g. figure 4, abstract, col. 2, line 67, etc.) and a 3 axis accelerometer to detect a change in posture of the patient (e.g. figures 1 and 4, col. 3, line 1), where a signal processor receives the heart rate and posture signals (e.g. col. 3, lines 7-14, etc.) from the sensor and accelerometer to extract features, construct a feature vector that has elements/features of the heart rate signal and change in posture (e.g. col. 3, line 15 to col. 4, line 9, etc.) to detect a change in hydration in response to detecting a change in posture of the subject and the feature vector (e.g. col. 3, line 8 to col. 5, line 18, etc.). As to claims 12 and 17, as Russell uses a 3 axis accelerometer bioharness around the torso (e.g. figure 3, etc.), he will measure inclination of the torso in relation to an upright position. Russell does disclose a computer algorithm to perform the classifying/use of the feature vector to determine hydration but does not specifically state that the hydration is quantified by classifying the feature vector “using machine learning” and the extracted features include a frequency domain representation of the heart rate signal. Selvaraj teaches it is known to measure heart rate to determine hydration where the system and method uses machine learning on the inputted data to extract feature vectors (e.g. col. 7, lines 3-14, lines 29-39, etc.) and the use of the frequency domain as an extracted feature for the feature vector (e.g. col. 8, lines 23-31, etc.) to allow the algorithm to learn from data and improve its performance without explicit programming, and to use the frequency domain to reveal aspects in the data that may not be apparent in the time domain and/or easily allow removal of noise. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Russell, with the system and method using machine learning on the inputted data to extract feature vectors and the use of the frequency domain as an extracted feature for the feature vector, as taught by Salvaraj, to provide the predictable results of allowing the algorithm to learn from data and improve its performance without explicit programming, and of using the frequency domain to reveal aspects in the data that may not be apparent in the time domain and/or easily allow removal of noise.
Claims 13, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Russell in view of Selvaraj (i.e. “modified Russell”). Modified Russell discloses the claimed invention except for the extracted feature comprises applying a Fourier transform or wavelet transform to the heart rate signal and classifying the feature vector using random decisions trees. It would have been obvious to one having ordinary skill in the art at the time the invention was made (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by modified Russell, with the extracted feature comprises applying a Fourier transform or wavelet transform to the heart rate signal and classifying the feature vector using random decisions trees, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of using a convention frequency transform to convert the signal into the frequency domain to reveal aspects in the data that may not be apparent in the time domain and/or easily allow removal of noise, and using random decision trees since it combines the outputs of multiple decision trees to reach a single result where it is used since it is versatile, easy to use, and handles complex data efficiently.
Claims 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Russell in view of Selvaraj (i.e. “modified Russell”). Modified Russell discloses the claimed invention and classifying as hydrated or dehydrated with different percentages for notification, such as 3% and 5%, and states that the different people can choose different percentages to be notified so the system can be customized by each individual person (e.g. col. 4, lines 5-37,etc.). This provides a clear suggestion that percentages of the notification of the dehydration can be modified to be customized to each individual. The determination of the most appropriate percentage, such as 1% and 2% by routine experimentation would, therefore, be prima facie obvious to one having ordinary skill in the medical art. In addition, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Response to Arguments
Applicant's arguments filed 8/12/25 have been fully considered but they are not persuasive.
--112(a)
The argument that the application describes how to construct a feature vector that includes a frequency domain representation, and that the application describes how the machine learning model is trained is not persuasive and amounts to a general allegation of patentability by repeating claim language.
The written description mentions using a frequency domain representation in the heart rate signal, but goes no further in describing how the feature vector using the frequency domain representation is processed to quantify hydration by classifying the frequency domain feature vector. No equations or further guidance is given. While the applicant/inventors had a general idea of performing this activity, they did not possess the details of how the idea is carried out using a frequency domain representation and the specifics of exactly how the feature vector includes a frequency domain representation of heart rate signals and what exactly is done with the frequency domain feature vector to determine hydration.
According to MPEP 2161.01, “[W]hen examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may "express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008) (internal citation omitted). It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)”.
Similarly, the written description briefly mentions classifying the feature vector into a class selected from a group consisting of hydrated, dehydrated by one percent and dehydrated by two percent. However the applicant/inventors only had a general idea of performing this activity, and they did not possess the details of how the idea is carried out and the specifics of exactly how they determine if a patient is dehydrated by 1% and 2%.
The applicant argues that the machine learning model is trained to perform these functions, but only repeats the claim language. As set forth in MPEP 2161.01, “original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed”.
The applicant argues that “named inventors published multiple publication describing and demonstrating how to implement the claimed invention”. It is noted that none of those publications were provided and are not part of the written description. It is also noted the applicants duty to disclose information that is material to the patentability of the invention. It is unclear why these publications have not been submitted. See 37 CFR 1.56.
--101
The argument that measuring heart rate with a sensor is not insignificant extra-solution activity is not persuasive. The sensor is only used to gather data for the abstract idea/mental concept/mathematical concept. Similar limitations are set forth in “Appendix 1 to the October 2019 Update: Subject Matter Eligibility”, example 45, in claim 1 to injection molding having a limitation to “(a) repeatedly obtain measurements of the temperature of a mold”. The claim was found to be ineligible and limitation (a) when “so evaluated, this additional element represents mere data gathering (obtaining the temperature values) that is necessary for use of the recited judicial exception (the temperature values are used in limitation (b)’s mathematical concept) and is recited at a high level of generality. Limitation (a) in the claim is thus insignificant extra-solution activity”.
When discussing actions to prevent a disease (i.e. “prophylaxis”), MPEP 2106.04(d)(2) discusses that the “prophylaxis limitation must impose meaningful limits on the judicial exception, and cannot be extra-solution activity or a field-of-use. For example, consider a claim that recites (a) administering rabies and feline leukemia vaccines to a first group of domestic cats in accordance with different vaccination schedules, and (b) analyzing information about the vaccination schedules and whether the cats later developed chronic immune-mediated disorders to determine a lowest-risk vaccination schedule. Step (b) falls within the mental process grouping of abstract ideas enumerated in MPEP 2106.04(a). While step (a) administers vaccines to the cats, this administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited exception. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application”. Similarly, the current claims use of a heart rate sensor is performed in order to gather data for the mental analysis step(s).
The argument that the claimed elements are integrated into a practical application by improving technology, or improves another technology, is not persuasive. The technology recited of a computer implemented method using a heart rate sensor and signal processor is well-understood and conventional as seen by the prior art of Russell, or Russell in view of Selvaraj. The improvement suggested by the applicant is just in how the data is processed using the frequency domain representation feature. It is important to note, the judicial exception alone cannot provide the improvement (MPEP 2106.05(a)).
--103
The argument that the examiner concedes that “Russell does not teach or suggest classifying feature vectors to determine hydration” is not persuasive as the examiner did not state this. The examiner stated that Russell “does” disclose a computer algorithm to perform the classifying/use of the feature vector to determine hydration but “does not specifically state that the hydration is quantified by classifying the feature vector “using machine learning””. In other words, Russell discloses everything except the simple use of machine learning in the computer algorithm. Selvaraj is one example of many showing the well-known use of machine learning in medical devices to analyze data and find patterns in the data to automate tasks such as patient diagnoses.
The argument that Selvaraj is concerned with monitoring basal heart rate when the patient is inactive and therefore teaches away from using measurements when the subject is changing posture is not persuasive. Selvaraj was not used as a teaching for monitoring heart rate, but used as a teaching to show the well-known use of machine learning to analyze data. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In addition, Russell also takes heart rate measurements when the patient is stationary in a particular posture (e.g. col. 3, line 40 to line 64, etc.) and therefore does not teach away.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/George R Evanisko/Primary Examiner, Art Unit 3792 11/20/25