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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-9 and 19-20 in the reply filed on June 1, 2026 is acknowledged.
Status of Claims
Claims 1-20 are pending.
Claims 10-18 are non-elected.
This communication is in response to the communication filed June 1, 2026.
Claim Rejections - 35 USC § 112(b)
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.
Claims 2-3 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The term “approximately” in claims 2 and 3 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 1-9 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite systems and methods for generating a treatment plan, which are statutory categories of inventions.
Specifically, the independent claims, taking claim 1 as exemplary, recite: determining an activity behavior score for the current user, based on receiving self-monitoring activity inputs and automatically monitoring activity performance…; determining a carbohydrate behavior score of the current user, based on self-monitoring carbohydrate inputs and carbohydrate performance; determining a medicine behavior score of the current user, based on the current user's consumption of medicine in accordance with a medicine schedule; identifying a user cluster for the user, from a plurality of clusters, the plurality of clusters determined based on: receiving initial user activity behavior scores, carbohydrate behavior scores, and medicine behavior scores for a plurality of initial users; and generating the plurality of user clusters…to the initial user activity behavior scores, carbohydrate behavior score, and medicine behavior scores for the plurality of initial users; determining a current user metabolic metric trend for the user based on the identified user cluster; and generating a treatment plan for the current user to improve a metabolic metric outcome based on the current user metabolic metric trend. The dependent claims recite limitations directed towards medication scores, behavior scores, performing calculations, weighting various types of data, determining scores, and using user inputs.
The claim limitations are interpreted as being grouped within the “certain methods of organizing human activity” grouping of abstract ideas, because the claims involve a series of steps for collecting user information and data, analyzing it by making various calculations and determinations, and outputting the results of the collection and analysis as a treatment plan. See MPEP 2106.04. The claims are interpreted to recite concepts relating to tracking or organizing metabolic information. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. Integration into a practical application requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. Here, the additional elements of the claims include motion sensor, electronic device, clustering algorithm, memory, and processor.
The claims merely use the additional elements as tools to perform abstract ideas and generally link the use of a judicial exception to a particular technological environment. The use of the additional elements as tools to implement the abstract idea and generally to link the use of the abstract idea to a particular technological environment does not render the claim patent eligible, because it requires no more than a computer performing functions that correspond to acts required to carry out the abstract idea. Specifically, the memory may be any or all types of tangible memory and function to store data and instructions (specification par. 138). The processor may be any kind of processor functioning to analyze and process data (par. 137-138). The clustering algorithm may be any type of algorithm or machine learning function to perform k-means clustering and segmentation (par. 51). The motion sensor may be part of the electronic device such as a glucose monitor functioning to collect and output data (par. 59).
The additional elements do not show an improvement to the functioning of a computer or to any other technology, rather the additional elements perform general computing functions and do not indicate how the particular combination improves any technology or provides a technical solution to a technical problem. See Apple v. Ameranth, 842 F.3d 1229, 1240 (Fed. Cir. 2016). The additional elements do not use the exception to affect a particular treatment or prophylaxis for a disease, do not apply the exception using particular machines, and do not effect a transformation or reduction of a particular article to a different state or thing, rather the computer elements are generally stated as to their structure and function and are only used to generate treatment plans instead of directly providing specific treatment or prophylaxis. Therefore, the additional elements do not impose any meaningful limits on practicing the abstract idea and the additional limitations are not indicative of materializing into a practical application. Accordingly, the claim is directed to an abstract idea.
Generic computer elements recited as performing generic computer functions that are well-understood, routine, or conventional activities amount to no more than implementing the abstract idea with a computerized system (Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network and performing repetitive calculations); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."); See MPEP 2106.05(d) and July 2015 Update: Section IV). Here, the claim limitations directed to determining scores, trends, weighting, and calculations are similar to performing repetitive calculations; and the claim limitations directed to receiving monitoring activity, user activity, and other information or data are similar to receiving and sending information over a network.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the steps of the claims amount to no more than using computer related devices to automate or implement the abstract idea of generating a treatment plan.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing. Therefore, the claims are not patent eligible.
In conclusion, the claims are directed to the abstract idea of generating a treatment plan. The claims do not provide an inventive concept, because the claims do not recite additional elements or a combination of elements that amount to significantly more than the judicial exception of the claims. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and the collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an order combination, the claims are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Allowable Subject Matter
The prior art recites generating a treatment plan for the current user to improve a metabolic metric outcome based on the current user metabolic metric trend. The closest prior art references of Kiani et al., Derrick et al., Mok, and Schentag et al. teach next generation designer liver organoids, diabetes informed by social determinants of health, combining medication adherence and diagnostic lab scores to determine intervention, and providing personalized pharmaceutical compositions and dosages, but do not specifically teach or suggest the following limitations recited in Claims 1-9 and 19-20: receiving initial user activity behavior scores, carbohydrate behavior scores, and medicine behavior scores for a plurality of initial users; and generating the plurality of user clusters by applying a clustering algorithm to the initial user activity behavior scores, carbohydrate behavior score, and medicine behavior scores for the plurality of initial users; determining a current user metabolic metric trend for the user based on the identified user cluster.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY M. PATEL whose telephone number is (571)272-6793 and email is jay.patel2@uspto.gov. The examiner can normally be reached on Monday-Friday 8AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H. Choi can be reached on (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAY M. PATEL/Primary Examiner, Art Unit 3686
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