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 .
Status of Claims
This action is in response to the response filed 9/10/2025.
Claims 5-6, 17-18 were canceled 9/10/2025.
Claims 1 and 13 were amended 9/10/2025.
Claims 1-4, 7-16 and 19-24 are currently pending are currently pending and have been examined.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 7-16 and 19-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No.12040096. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions have significantly similar claim limitations of the independent claims that recite: obtaining training data for a plurality of patients of a patient population, the training data comprising, for each corresponding patient of the patient population, one or more ADM dose-combinations administered by the corresponding patient, associated with the one or more ADM dose-combinations administered by the corresponding patient, and training patient-state information, processing the training data obtained for each of the plurality of patients of the patient population to train a predictive model capable of predicting ADM dose-combinations for the treated patient; for each patient of the patient population, identifying, using the trained predictive model, an optimum ADM dose-combination that yields an outcome attribute associated with bringing and maintain a corresponding glucose level of the patient closest to a glucose target center of the glucose target range; receiving patient-state information for the treated patient; determine a recommended ADM dose-combination for the treated patient based on one or more of the identified optimum ADM dose-combinations associated with patients of the patient population having training patient-state information similar to the patient-state information for the treated patient; and transmitting the recommended ADM dose-combination for the treated patient. The dependent claims are identical.
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 1-4, 7-16 and 19-24 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.
Claims 1-4, 7-16 and 19-24 are drawn to a method and a system which are statutory categories of invention (Step 1: YES).
Independent claims 1 and 13 recite perform operations for determining treatment doses of anti-diabetes medications (ADMs) for a treated patient, the operations comprising: obtaining training data for a plurality of patients of a patient population in communication, the training data comprising, for each corresponding patient of the patient population: one or more ADM dose-combinations administered by the corresponding patient; a glycated hemoglobin measurement associated with the one or more ADM dose- combinations administered by the corresponding patient; and training patient-state information; processing the training data obtained for each of the plurality of patients of the patient population capable of predicting ADM dose- combinations for the treated patient; for each patient of the patient population, identifying, an optimum ADM dose-combination that yields the outcome attribute associated with bringing and maintaining a glucose level of the corresponding patient of the patient population closest to a glucose target center of the glucose target range; receiving patient-state information for the treated patient; receiving a glycated hemoglobin measurement for the treated patient; determining a recommended ADM dose-combination for the treated patient based on the glycated hemoglobin measurement for the treated patient and one or more of the identified optimum ADM dose-combinations associated with patients of the patient population having training patient-state information similar to the patient-state information for the treated patient; and transmitting the recommended ADM dose-combination for the treated patient associated with the treated patient, display the recommended ADM dose-combination for the treated patient.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity of patients in a patient population and a user, as reflected in the specification, which states that “the training program 300a may build the decision tree for a patient population based on the patient-state information 208a, BG history data 208b, and the SubQ information 208c for each patient of the patient population. Accordingly, the decision tree may be retrieved from the non-transitory memory 24, 114, 124 for use by the patient treatment program 300b to allow the user 40 (e.g., physician or medical professional) to prescribe a personalized patient treatment therapy for a patient 10.” (see: specification paragraph 86). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address “For commencing the training program 300a or the patient treatment program 300b, the process prompts a user 40 to input patient information 208a-c at block 208. The user 40 may input the patient information 208a-c, for example, via the user device 110 or via the health care provider medical record system 140 located at a clinic 42 (or a doctor's office). The user 40 may input new patient information 208a-c as shown in FIG. 2B. The process 200 may retrieve the patient information 208a-c from the nontransitory memory 144 of the clinic's electronic medical system 140 or the non-transitory memory 114 of the patient device 110 ( e.g., where the patient information 208a-c was previously entered and stored).” (see: specification paragraph 69). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “train a predictive model, trained predictive model”, “computer”, “data processing hardware”, “memory hardware”, “portable device”, “system”, “dosing controller” are recited at a high level of generality (e.g., that the training and displaying is performed using generic computer components with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
The claims do 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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1A-1C and
Paragraph 140, where “Implementations of the subject matter and the functional operations described in this specification can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Moreover, subject matter described in this specification can be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a computer readable medium for execution by, or to control the operation of, data processing apparatus. The computer readable medium can be a machine-readable storage device, a machine-readable storage substrate, a memory device, a composition of matter effecting a machine-readable propagated signal, or a combination of one or more of them. The terms "data processing apparatus”, "computing device” and "computing processor" encompass all apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, or multiple processors or computers” °
Paragraph 136, where “Referring to FIG. 5, a method 500 of determining a treatment dose of insulin for a treated patient 10 includes obtaining 502 training data 310 for a plurality of patients of a patient population at data processing hardware 112, 132, 142, 192 from memory hardware 24, 114, 134, 144, 194 in communication with the data processing hardware1 12, 132, 142, 192”
Paragraph 63, where “The dosing controller 160 is in communication with the glucometer 124, insulin administration device 123a, 123b and includes a computing device 112, 132, 142 and non-transitory memory 114, 134, 144 in communication with the computing device 112, 132, 142. The dosing controller 160 executes the process 200. The dosing controller 160 stores patient related information retrieved from the glucometer 124 to determine an insulin dose rate IRR based on the received blood glucose measurement BG. The dosing controller 160 may store blood glucose BG history data 208b associated with the patient IO that includes treatment doses and outcome attributes associated with each treatment dose administered by the patient.”
Paragraph 137, where “The method 500 includes transmitting 510 the next recommended treatment dose to a portable device 110, 123, 124 associated with the treated patient. The portable device 110, 123, 124 may display the next recommended treatment dose.
Paragraph 66, “To accomplish this, it retrieves a set of new training data 308 from the BG history data 208b and processes it to learn an up-to-date predictive model capable of predicting glycemic variables for a wide number of patient-profiles. From the training data 308, the training program 300a uses patient-state information 208a, BG history data 208b, and/or SubQ information 208c to tabulate counts and calculate probabilities, averages, regression functions, and/or other statistical data that may be saved (in the non-transitory memory 114, 134, 144). After the training run is complete, the probabilities and other statistical data are available for use by the treatment program 300b to predict an optimum treatment dose for the patient 10 that will yield a favorable outcome attribute.”
Paragraph 78, “The training program processes the new training data at block 310 to obtain counts and calculate probabilities in the manner of tree-training based on the patient's patient-state information 208a, BG history data 208b, and/or SubQ information 208c. The training program 300a may obtain the new training data at block 310 chronologically one dose adjustment (e.g., bolus or basal) at a time. The BG history data 208b may include a calculation of an insulin dose administered to the patient 10 and the outcome data associated with the insulin dose, obtained at a time when the next scheduled blood glucose measurement BGnext shows the result of the administered insulin dose.”
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with route, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claims 1-4, 7-12, 14-16 and 19-24 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Response to Arguments
The arguments filed 9/10/2025 have been fully considered.
A double patenting rejection remains as there is no terminal disclaimer.
Regarding the arguments pertaining to the 101 rejection, these arguments are not persuasive. Applicant argues that the claimed invention is directed to a specific, technological method for determining personalized anti-diabetes medication dosages by processing specific long-term biological markers and cannot be performed in the mind. However, the claimed invention is directed towards the abstract idea of Certain Methods of Organizing Human Activity as the claimed invention is directed towards a physician prescribing medical treatment towards a patient (paragraph 69). The claimed invention is dissimilar to Enfish as it does not provide a technological improvement to solve a technical problem.
Applicant further argues that the claimed invention is providing a specific technical solution a technical problem by managing long-term, non-insulin diabetes treatment outcomes. This is inherently part of the abstract idea of organizing human activity. The claimed invention is directed towards the outcomes of patients being treated by a physician using the invention and is not a technological solution to a technical problem, but a medical provider solution to a patient problem (i.e., organizing human activity). Dosing recommendations and managing treatment doses for a patient are part of the medical field of interactions between a provider and a patient. The “medical field” is not necessarily a “technical field”, nor is a treatment effected. Classen is an example of adding a meaningful limitation to the claims that create a practical application, however Classen integrated the results of the analysis into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application” (Classen Immunotherapies Inc. v. Biogen IDEC).
Applicant further argues that the claimed invention includes complex statistical analysis across a large dataset to train a predictive model is directed to a specific technological improvement. However, the specification recites that the predictive model is a generic machine learning model run on a generic computing device and does not provide a specific technological improvement (paragraphs 66, 78, 140). Using specific data does not provide a technological improvement to a technical problem.
The functions argued are representative of the abstract idea. The claims here are not directed to a specific improvement to computer functionality that amount to a practical application. Rather, they are directed to the use of conventional or generic technology in a well-known environment, without any claim that the invention reflects an inventive solution to a technical problem presented by combining the two. In the present case, the claims fail to recite any elements that individually or as an ordered combination transform the identified abstract idea(s) in the rejection into a patent-eligible application of that idea.
Further, not every claim that recites concrete, tangible components escapes the reach of the abstract-idea inquiry. (See, e.g., Alice, 134). It is well-settled that mere recitation of concrete, tangible components that are generic is insufficient to confer patent eligibility to an otherwise abstract idea. In order to amount to an inventive concept, the components must involve more than performance of “’well-understood, routine, conventional activities’ previously known to the industry.” (Alice, 134 S. Ct. at 2359 (quoting Mayo, 132 S.Ct. at 1294)). The originally filed specification was investigated and found to support this conclusion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gopal (WO 2-12/108940 A1) teaches using statistical processes to determine diabetic dosaging for patients.
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.
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/K.A.S./ Examiner, Art Unit 3686
/JASON B DUNHAM/ Supervisory Patent Examiner, Art Unit 3686