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 § 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.
Step 1
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-10 are directed to a process, and, claims 13-20 are directed towards a method; thus, each of the pending claims are directed to a statutory category of invention.
Step 2A Prong One
Claim 1, representative of the claimed invention, recites the receive at least a cardiovascular sample relating to a user; receive a plurality of physical activities; generate at least a cardiovascular parameter as a function of the at least a cardiovascular sample; determine a cardiovascular profile as a function of the at least a cardiovascular parameter and at least a cardiovascular deficiency, wherein: the at least a cardiovascular deficiency is compared to a cardiovascular threshold; the cardiovascular profile includes a numerical cardiovascular health score correlated to the at least a cardiovascular parameter; and the cardiovascular profile comprises an atherosclerosis indicator correlated to the at least a cardiovascular parameter, wherein the atherosclerosis indicator includes a location in a user’s body wherein a vein or artery is accumulating plaque buildup; identify a plurality of nutritional elements as a function of the cardiovascular profile, wherein identifying the plurality of nutritional elements comprises classifying the cardiovascular profile to a cardiovascular disease category using a classifier machine-learning model; determine a nourishment score as a function of a nutritional element machine-learning model and the cardiovascular profile, wherein the nutritional element machine- learning model is trained using training data correlating the identified plurality of nutritional elements to an effect a nutritional element of the plurality of nutritional elements has on the cardiovascular profile: generate a lifestyle program as a function of the cardiovascular profile, wherein generating the lifestyle program comprises: correlating at least a physical activity from the plurality of physical activities to the at least a cardiovascular parameter; and assigning the at least a physical activity to the user as a function of the correlation.
The limitations above, as drafted, recite a process that, under its broadest reasonable interpretation, encompass mental processes and also certain methods of organizing human activity. The claimed steps recite several steps that include observations, evaluations, judgments and opinions, and “can be performed in the human mind, or by a human using a pen and paper” which have been considered by the courts to be a mental process. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). The claimed steps also are directed towards managing personal behavior (e.g., assessing a patient and making recommendations).
Apart from the use of generic technology (discussed further below), each of the limitations recited above describes activities that would encompass actions performed in collecting information regarding a patient and providing activity recommendations.
Based on the broadest reasonable interpretation in light of the specification, these activities describe concepts relating to managing personal behavior and mental processes in that the activities relate to collecting information regarding a patient and providing activity recommendations. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, commercial interactions, or fundamental economic practices, then it falls within the “Method of Organizing Human Activity” grouping of abstract ideas. The recited steps also are considered to be a mental process as methods that can be performed mentally, or which are the equivalent of human mental work. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application. In particular, claims 1 and 13 recites the additional elements of a computer device and machine learning models. The computer device are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of receiving information, performing calculations, and providing/transmitting information) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Likewise, the machine learning model is implemented as a tool to perform an abstract idea. The claim is directed to an abstract idea.
This judicial exception is not integrated into a practical application because the generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a processor to perform the steps of “receive at least a cardiovascular sample relating to a user; receive a plurality of physical activities; generate at least a cardiovascular parameter as a function of the at least a cardiovascular sample; determine a cardiovascular profile as a function of the at least a cardiovascular parameter and at least a cardiovascular deficiency, wherein: the at least a cardiovascular deficiency is compared to a cardiovascular threshold; the cardiovascular profile includes a numerical cardiovascular health score correlated to the at least a cardiovascular parameter; and the cardiovascular profile comprises an atherosclerosis indicator correlated to the at least a cardiovascular parameter, wherein the atherosclerosis indicator includes a location in a user’s body wherein a vein or artery is accumulating plaque buildup; identify a plurality of nutritional elements as a function of the cardiovascular profile, wherein identifying the plurality of nutritional elements comprises classifying the cardiovascular profile to a cardiovascular disease category using a classifier machine-learning model; determine a nourishment score as a function of a nutritional element machine-learning model and the cardiovascular profile, wherein the nutritional element machine- learning model is trained using training data correlating the identified plurality of nutritional elements to an effect a nutritional element of the plurality of nutritional elements has on the cardiovascular profile: generate a lifestyle program as a function of the cardiovascular profile, wherein generating the lifestyle program comprises: correlating at least a physical activity from the plurality of physical activities to the at least a cardiovascular parameter; and assigning the at least a physical activity to the user as a function of the correlation” amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Similarly, use of a computer performing a machine learning model is a tool to perform the abstract idea. See MPEP 2106.05(f): “[u]se of 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 integrate a judicial exception into a practical application or provide significantly more.” An example where the courts have found the additional elements to be mere instruction to apply an exception, because they do no more than merely invoke computers or machinery as a tool to perform an existing process includes a commonplace business method or mathematical algorithm being applied on a general purpose computer, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223 (MPEP 2106.05(f)(2)). The use of a machine learning model emulates what the medical or pharmacy practitioner does in reading patient results and making health recommendstions. Thus, even considering the additional elements in combination, the claims do not include elements that are significantly more than the judicial exception.
Step 2B
Limitations that the courts have found to qualify as “significantly more” when recited in a claim with a judicial exception include:
i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).
Claims 1 and 13 are not similar to any of these limitations.
Limitations that the courts have found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
i. Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
iii. Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
iv. Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
Claims 1 and 13 recite additional elements that are regarded as “apply it” as seen in the Step 2A Prong 2 discussion above. The claims do not set forth a solution to a problem rooted in technology (e.g., technical solution), as collecting patient health data to identify deficiencies and recommendations to correct or remedy said deficiencies predate the use of computers or machine learning models.
Looking at the limitations of claims 1 and 13 as an ordered combination 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, effects a transformation of subject matter to a different state or thing, applies the use of a particular machine, integrate the abstract idea into a practical application or provide any meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Therefore, claims 1 and 13 are not patent eligible.
The dependent claims further describe the abstract idea and do not recite a practical application or significantly more than the judicial exception. None of dependent claims 2-12 or 14-20 recite any further additional elements. Dependent claims 2-12 and 14-20 further narrow the scope of the abstract idea in claims 1 and 13 by providing additional information or considerations used in the analysis.
Thus, claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
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.
Claim(s) 1-3, 6, 7, 11-13, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2020/0058404 to Nazem et al. in view of U.S. Patent 11,183,080 to Wolf et al.
As to claims 1 and 11, Nazem discloses a system for generating cardiovascular health programs, the system comprising:
a computing device, the computing device configured to:
receive at least a cardiovascular sample relating to a user (Nazem [0007]);
receive a plurality of physical activities (Nazem paragraph [0010]-[0011]);
generate at least a cardiovascular parameter as a function of the at least a cardiovascular sample (Nazem [0013]);
determine a cardiovascular profile as a function of the at least a cardiovascular parameter and at least a cardiovascular deficiency, wherein:
the at least a cardiovascular deficiency is compared to a cardiovascular threshold (Nazem [0013]);
the cardiovascular profile includes a numerical cardiovascular health score correlated to the at least a cardiovascular parameter (Nazem [0013]); and
the cardiovascular profile comprises an atherosclerosis indicator correlated to the at least a cardiovascular parameter, wherein the atherosclerosis indicator includes a location in a user’s body wherein a vein or artery is accumulating plaque buildup (Nazem [0071]-[0073]);
generate a lifestyle program as a function of the cardiovascular profile, wherein generating the lifestyle program comprises:
correlating at least a physical activity from the plurality of physical activities to the at least a cardiovascular parameter (Nazem [0109]); and
assigning the at least a physical activity to the user as a function of the correlation (Nazem [0109]).
However, Nazem does not explicitly teach identifying, by the computing device, a plurality of nutritional elements as a function of the cardiovascular profile, wherein identifying the plurality of nutritional elements comprises classifying the cardiovascular profile to a cardiovascular disease category using a classifier machine-learning model; determining, by the computing device, a nourishment score as a function of a nutritional element machine-learning model and the cardiovascular profile, wherein the nutritional element machine-learning model is trained using training data correlating the identified plurality of nutritional elements to an effect a nutritional element of the plurality of nutritional elements has on the cardiovascular profile. Wolf discloses identifying, by the computing device, a plurality of nutritional elements as a function of the cardiovascular profile, wherein identifying the plurality of nutritional elements comprises classifying the cardiovascular profile to a cardiovascular disease category using a classifier machine-learning model; determining, by the computing device, a nourishment score as a function of a nutritional element machine-learning model and the cardiovascular profile, wherein the nutritional element machine-learning model is trained using training data correlating the identified plurality of nutritional elements to an effect a nutritional element of the plurality of nutritional elements has on the cardiovascular profile (Wolf abstract and column 3 lines 5-52).
It would have been obvious to utilize machine learning to generate nutritional recommendations for a cardiovascular profile as in Wolf in the system of Nazem to improve the accuracy of nutritional advice.
As to claims 2 and 12, see the discussion of claim 1, additionally, Nazem discloses the system wherein generating the lifestyle program comprises receiving a user choice regarding an activity (Nazem [0053]).
As to claims 3 and 13, see the discussion of claim 1, additionally, Nazem discloses the system wherein computing device is further configured to generate the lifestyle program using a lifestyle program classifier (Nazem [0053]).
As to claims 6 and 16, see the discussion of claim 1, additionally, Nazem discloses the system wherein the computing device is further configured to calculate the numerical cardiovascular health score, wherein calculating the numerical cardiovascular health score comprises:
assigning a first numerical score to the at least a cardiovascular parameter as a function of the cardiovascular threshold (Nazem [0094]-[0098]);
assigning a second numerical score to at least a physical activity associated with the at least a cardiovascular parameter (Nazem [0094]-[0098]); and
calculating the numerical cardiovascular score as a function of the second numerical score and the first numerical score (Nazem [0094]-[0098]).
As to claim 7 and 17, see the discussion of claim 6, additionally, Nazem discloses the system wherein the computing device is further configured to minimize the numerical cardiovascular score as a function of the at least a physical activity from the plurality of physical activities (Nazem [0094]-[0098]).
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.
Claim(s) 4, 5, 8-10, 14, 15, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2020/0058404 to Nazem et al. in view of U.S. Patent 11,183,080 to Wolf et al. in view of U.S. Patent Application Publication 2021/0241139 to Jain et al.
As to claims 4 and 14, see the discussion of claim 3, however, Nazem does not explicitly teach the system wherein the computing device is further to train a classification machine learning model using a lifestyle training set. Jain discloses wherein the computing device is further to train a classification machine learning model using a lifestyle training set (Jain [0353]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the invention by applicant to train a model using lifestyle data as in Jain in the system of Nazem to gain insights using known risk factors to improve the therapeutic value of assigned activities.
As to claims 5 and 15, see the discussion of claim 4, additionally, Jain discloses the system wherein the lifestyle training set comprises previous iterations classification machine learning model (Jain [0353] and [0338]).
As to claims 8 and 18, see the discussion of claim 1, however, Nazem does not explicitly teach the system wherein generating the lifestyle program comprises generating an activity adherence score. Jain discloses wherein generating the lifestyle program comprises generating an activity adherence score (Jain [0272]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the invention by applicant to monitor adherence as in Jain in the system of Nazem to improve patient outcomes by ensuring proper treatment of their conditions.
As to claims 9 and 19, see the discussion of claim 1, however, Nazem does not explicitly teach the system wherein the computing device is further configured to modify the activity adherence score. Jain discloses wherein the computing device is further configured to modify the activity adherence score (Jain [0272], [0277]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the invention by applicant to monitor adherence as in Jain in the system of Nazem to improve patient outcomes by ensuring proper treatment of their conditions.
As to claim 10 and 20, see the discussion of claim 1, however, Nazem does not explicitly teach the system wherein the computing device is further configured to modify the lifestyle program as a function of the activity adherence score. Jain discloses wherein the computing device is further configured to modify the lifestyle program as a function of the activity adherence score (Jain [0272]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the invention by applicant to monitor adherence as in Jain in the system of Nazem to improve patient outcomes by ensuring proper treatment of their conditions.
Response to Arguments
Applicant's arguments filed 7/30/2025 have been fully considered but they are not persuasive. With respect to the 101 rejection, Applicant argues that the amended portion cannot be performed in the human mind. The question of step 2A prong one determines whether the claim contains an abstract idea. This newly added limitation is considered an additional element. With respect to prong 2, applicant argues that the claimed feature of using a classifier machine learning model solves a technical problem in cardiovascular health management or an improvement over traditional methods of manually assessing nutrition recommendations and cardiovascular health outcomes. The claims do not recite a s solution to a technical problem in computers such as separating speech signals or security in computer networks. Rather the claims are directed to automating a mental process of providing nutrition recommendations. The recitation of a machine learning algorithm is merely used as a tool to perform the function.
With respect to the 102 rejection, Applicant’s arguments are moot in view of new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eliza Lam whose telephone number is (571)270-7052. The examiner can normally be reached Monday-Friday 8-4:30PST.
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/ELIZA A LAM/Primary Examiner, Art Unit 3681