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 .
DETAILED ACTION
Response to Amendment
The present Office Action is in response to the Request for Continued Examination dated 02/17/2026.
In the amendment dated 02/17/2026, the following occurred: Claim 1, 3, 12, 23, 38 has been amended. Claim 2, 5-11, 13-14, 16-17, 19, 22, 28, 31-32, 34, 36-37 and 39-40 were canceled.
Claims 1, 3, 4, 12, 15, 18, 20, 21, 23-27, 29-30, 33, 35, 38 and 41-44 are currently pending.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 3, 4, 12, 15, 18, 20, 21, 23-27, 29-30, 33, 35, 38 and 41-44 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, 23 and 38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method and a system for generating diagnosis.
Regarding claims 1, 23 and 38, the limitation of (claim 1 being representative) receiving inputs including (i) data indicative of a plurality of therapeutically active biologics and associated route of administration for each therapeutically active biologic, wherein the plurality of therapeutically active biologics belong to the set of therapeutically active biologics; (ii) initial concentration data indicative of one or more concentration levels of a previously administered therapeutically active biologic belonging to the set of therapeutically active biologics in one or more samples obtained from the individual, (iii) physiological data indicative of one or more measurements of at least one physiological parameter of the individual, and (iv) a target exposure level of the therapeutically active biologic expected to achieve the treatment objective in the individual; determining, based on the received inputs, parameters for a computational model that generates a prediction of a concentration time profile resulting from administration of any therapeutically active biologic belonging to the set of therapeutically active biologics to the individual, wherein the computational model is selected from among a plurality of computational model stored and further wherein the computational model is representative of a plurality of responses received from a plurality of patients and each response is indicative of a patient’s response to at least one of the therapeutically active biologics in the set of therapeutically active biologics, and wherein the computational model is not specific to any particular therapeutically active biologic and the computational model is configured to provide a dosage that is applicable to any therapeutically active biologic in the set of therapeutically active biologics; applying the determined parameters to the computational model and receiving from the computational model dosage of the therapeutically active biologics, wherein the dosage indicates (i) at least one dose amount of any therapeutically active biologic in the set of therapeutically active biologics and (ii) a recommended schedule for administering the at least one dose amount to the individual, the recommended schedule including a recommended time for administering a next dose to the individual, such that a predicted concentration time profile of any therapeutically active biologic in the set of therapeutically active biologics in the individual in response to the dosage is at or above the target exposure level of the therapeutically active biologic at the recommended time; administering the dosage to the individual and obtaining from the individual, after administration of the dosage, additional data comprising at least one of additional concentration data and additional physiological data; in response to the additional data indicating a decline in health of the individual, updating the inputs to (i) exclude at least a portion of the initial concentration data and (ii) include the additional physiological data in the inputs; updating, based on the updated inputs, the parameters for applying to the computational model; determining, using the computational model and the updated parameters, an updated dosage; and administering the updated dosage to the individual and regarding claim 23 and 38- the limitation of generating updated concentration data including the initial concentration data and the additional concentration data; dividing the updated concentration data into a subset and a remaining portion; updating the inputs, based on the updated concentration data indicating a material change in the initial concentration level of the drug in the individual, to (i) include the additional physiological data in the inputs, (ii) include the subset of the updated concentration data in the inputs, and (iii) exclude the remaining portion of the updated concentration data from the inputs as drafted, is a process that, under the broadest reasonable interpretation, covers a method organizing human but for the recitation of generic computer components. That is other than reciting a processor and a database, the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, but for the processor and database, the claims encompass a system and method for modifying adaptive dosing regimens in the manner described in the identified abstract idea, supra. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer (see October 2019 Update: Subject Matter Eligibility at Pg. 5). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claims 1, 23 and 38 recite the additional elements of a processor and a database. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computer components for enabling access to medical information or for performing generic computer functions. See Specification at para. [0104], [0163] and [0164]) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because it does not impose any
The claim further recites the additional element of an administrating dosage and updated dosage to an individual. This additional element is recited at a high level of generality (i.e., as a general means of transmitting data) and amounts to extra-solution activity. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
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, the additional elements of the processor and the database to perform the noted steps 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 (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of an administrating a dosage and updated dosage to an individual was considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. As indicated in the Background section of Applicant’s Specification, administering a drug to a patient is a well-understood, routine, conventional activity. See also, the cited reference(s), infra. Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well-understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 3, 4, 12, 15, 18, 20, 21, 24-27, 29-30, 33, 35 and 41-43 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 3 further merely describe(s) updating the inputs in response to the additional concentration data. Claim(s) 3 further merely describe(s) the updated the inputs. Claim(s) 12 further merely describe(s) receiving historical data indicative of a response of the individual to at least one previously administered therapeutically active biologic. Claim(s) 15 further merely describe(s) the set of therapeutically active biologics. Claim(s) 16 further merely describe(s) the therapeutically active biologic. Claim(s) 20 further merely describe(s) the inputs. Claim(s) 21 further merely describe(s) the additional data. Claim(s) 24 further merely describe(s) the subset of the updated concentration data. Claim(s) 25 further merely describe(s) dividing the updated concentration data into a subset and a remaining portion. Claim(s) 26 further merely describe(s) the subset of the updated concentration data. Claim(s) 27 and 29 further merely describe(s) the subset. Claim(s) 30 further merely describe(s) when the additional concentration data is an anomaly, the remaining portion consists of the additional concentration data, and when the additional concentration data is not an anomaly, the subset consists of up to three most recent data points in the updated concentration data. Claim(s) 33 further merely describe(s) the therapeutically active biologic. Claim(s) 35 further merely describe(s) the inputs, dose amount and the route of administration. Claim(s) 41 further merely describe(s) the set of therapeutically active biologics. Claim(s) 42 and 43 further merely describe(s) the therapeutically active biologic. Claims 3, 4, 12, 15, 18, 20, 21, 24-27, 29-30, 33, 35 and 41-43 further define the abstract idea, encompass certain methods of organizing human activity and are rejected for the same reason presented above with respect to claims 1, 23 and 38.
Subject Matter Free of Prior Art
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within claims 1, 23 and 38. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: each of the following conditions, using the corresponding method: a method for treatment of an individual known to have an indication via administration of a dosage of a therapeutically active biologic in order to achieve a treatment objective in the individual, the therapeutically active biologic belonging to a set of therapeutically active biologics that are (a) known to treat the indication and (b) are expected to exhibit similar pharmacokinetic (PK) behavior, similar pharmacodynamic (PD) behavior, or both, wherein the indication includes a general inflammatory disease, an inflammatory bowel disease (IBD), an ulcerative colitis, Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, asthma, or multiple sclerosis, the method comprising: receiving, using a processor coupled to a database, inputs including: (i) data indicative of a plurality of therapeutically active biologics and associated route of administration for each therapeutically active biologic, wherein the plurality of therapeutically active biologics belong to the set of therapeutically active biologics; (ii) initial concentration data indicative of one or more concentration levels of a previously administered therapeutically active biologic belonging to the set of therapeutically active biologics in one or more samples obtained from the individual; (iii) physiological data indicative of one or more measurements of at least one physiological parameter of the individual; and (iv) a target exposure level of the therapeutically active biologic expected to achieve the treatment objective in the individual; determining, using a processor and based on the received inputs, parameters for a computational model that generates a prediction of a concentration time profile resulting from administration of any therapeutically active biologic belonging to the set of therapeutically active biologics to the individual, wherein the computational model is selected from among a plurality of computational models stored in the database, and further wherein the computational model is representative of a plurality of responses received from a plurality of patients and each response is indicative of a patient's response to at least one of the therapeutically active biologics in the set of therapeutically active biologics, and wherein the computational model is not specific to any particular therapeutically active biologic and the computational model is configured to provide a dosage that is applicable to any therapeutically active biologic in the set of therapeutically active biologics; applying, using the processor, the determined parameters to the computational model and receiving from the computational model a dosage of the therapeutically active biologic, wherein the dosage indicates (i) at least one dose amount of any therapeutically active biologic in the set of therapeutically active biologics and (ii) a recommended schedule for administering the at least one dose amount to the individual, the recommended schedule including a recommended time for administering a next dose to the individual, such that a predicted concentration time profile of any therapeutically active biologic in the set of therapeutically active biologics in the individual in response to the dosage is at or above the target exposure level of the therapeutically active biologic at the recommended time; administering the dosage to the individual and obtaining from the individual, after administration of the dosage, additional data comprising at least one of additional concentration data and additional physiological data; in response to the additional data indicating a decline in health of the individual, updating the inputs to the processor to (i) exclude at least a portion of the initial concentration data and (ii) include the additional physiological data in the inputs; generating, using the processor, updated concentration data including the initial concentration data and the additional concentration data; dividing, using the processor, the updated concentration data into a subset and a remaining portion; updating the inputs, using the processor and based on the updated concentration data indicating a material change in the initial concentration level of the drug in the individual, to (i) include the additional physiological data in the inputs, (ii) include the subset of the updated concentration data in the inputs, and (iii) exclude the remaining portion of the updated concentration data from the inputs; updating, using the processor and based on the updated inputs, the parameters for applying to the computational model; and determining, using the processor and the computational model and the updated parameters, an updated dosage; and administering the updated dosage to the individual.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1, 3, 4, 12, 15, 18, 20, 21, 23-27, 29-30, 33, 35, 38 and 41-44, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
… Therefore, amended claim 1 is directed to a method for treatment of an individual who suffers from a particular disease or medical condition, which "affirmatively recite[s] an action that effects a particular treatment.. .for the [recited] disease[] or medical condition[]." See MPEP 2106.04(d)(2). The claim language recites actual administration of "a dosage of a therapeutically active biologic," using actual (additional) data from samples (e.g., blood samples) obtained from the patient following the first administration step, and actual administration of a second, updated dosage to the patient. Accordingly, when properly considered in view of the above framework, under Step 1 and Step 2A, the subject matter eligibility of amended claim 1 is straightforward - the amended claim is directed to a patent eligible method of treatment as plainly indicated on its face. Amended claim 1 is not directed to a law of nature, a natural phenomenon, or an abstract idea, and even if wrongly characterized as such, it integrates any such exception into a practical application.
Regarding 1, the Examiner respectfully disagrees. Claim 1 does not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or a medical condition (see the Vanda memo). Claim 1 uses generic computer components and applies any suitable computational model to perform the abstract idea of: receiving inputs including (i) data indicative of a plurality of therapeutically active biologics and associated route of administration for each therapeutically active biologic, wherein the plurality of therapeutically active biologics belong to the set of therapeutically active biologics; (ii) initial concentration data indicative of one or more concentration levels of a previously administered therapeutically active biologic belonging to the set of therapeutically active biologics in one or more samples obtained from the individual, (iii) physiological data indicative of one or more measurements of at least one physiological parameter of the individual, and (iv) a target exposure level of the therapeutically active biologic expected to achieve the treatment objective in the individual; determining, based on the received inputs, parameters for a computational model that generates a prediction of a concentration time profile resulting from administration of any therapeutically active biologic belonging to the set of therapeutically active biologics to the individual, wherein the computational model is selected from among a plurality of computational model stored and further wherein the computational model is representative of a plurality of responses received from a plurality of patients and each response is indicative of a patient’s response to at least one of the therapeutically active biologics in the set of therapeutically active biologics, and wherein the computational model is not specific to any particular therapeutically active biologic and the computational model is configured to provide a dosage that is applicable to any therapeutically active biologic in the set of therapeutically active biologics; applying the determined parameters to the computational model and receiving from the computational model dosage of the therapeutically active biologics, wherein the dosage indicates (i) at least one dose amount of any therapeutically active biologic in the set of therapeutically active biologics and (ii) a recommended schedule for administering the at least one dose amount to the individual, the recommended schedule including a recommended time for administering a next dose to the individual, such that a predicted concentration time profile of any therapeutically active biologic in the set of therapeutically active biologics in the individual in response to the dosage is at or above the target exposure level of the therapeutically active biologic at the recommended time; in response to the additional data indicating a decline in health of the individual, updating the inputs to (i) exclude at least a portion of the initial concentration data and (ii) include the additional physiological data in the inputs; updating, based on the updated inputs, the parameters for applying to the computational model; determining, using the computational model and the updated parameters, an updated dosage. There is no treatment in the claim and the claim lacks specificity. According to Applicant, “the recited claims relate to a clinical tool that improves dosing regimens fundamentally by tailoring the regimen to the individual patient's characteristics, based on whether a patient is responding to treatment, has a sudden decline in health, and/or is early in treatment.
Moreover, in amended claim 1, the administration and sample collection steps impose meaningful limits on the claimed method of treatment because they utilize the obtained information to develop an "updated dosage" for administering to the patient in order to achieve a treatment objective in the patient. The administration and additional data collection steps are directly and significantly related to steps (e), (f), and (g) of the claim and work together with these steps to provide a particular treatment to the recited indications. Together, these steps amount to significantly more than an abstract idea and/or a mere extra-solution activity… To the extent that the Office continues to incorrectly assert that amended claim 1 is abstract, this claim integrates any alleged abstractness into a practical application and a specific process that contributes to the treatment of the individual. Here, amended claim 1 recites treating an individual known an indication including "a general inflammatory disease, an inflammatory bowel disease (IBD), an ulcerative colitis, Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, asthma, or multiple sclerosis" using particular treatment steps that involve a first administration step (step (d)), a data collection step (step (d)), and a second administration step (step (h)). Therefore, the elements of amended claim 1 integrate any alleged abstractness into a practical application in a manner akin to those previously found patentable eligible by the Federal Circuit. See, e.g., Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011). Accordingly, amended claim 1 as a whole, including the arrangement and configuration of its limitations, is unmistakably patent eligible.
Regarding 2, the Examiner respectfully disagrees. Administering dosage/updated dosage was analyzed as an additional element and was determined to be insignificant extra-solution data gathering. This does not integrate the abstract idea into a practical application nor provide significantly more. As indicated in the Background section of Applicant’s Specification, administering a drug to a patient is a well-understood, routine, conventional activity. Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Conclusion
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Groen (US 2008/0008991) discloses system and method for optimizing drug therapy for the treatment of disease. Mould (US 2016/0300037) discloses systems and methods for patient-specific dosing. Rodger (US 2007/0099926) discloses combination therapy for treating chronic inflammatory disease. Bratzler (US 2003/0087848) discloses immunostimulatory nucleic acids for the treatment of asthma and allergy. Lancaster (US 2007/0099820) discloses polymer-drug conjugates. Robinson (US 2014/0275164) discloses desethylhydroxychloroquine for the treatment of disease associated with inflammation. Mayer (US 2004/0193446) discloses system and method for managing a patient treatment program including a prescribed drug regimen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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, Robert Morgan can be reached on 571-272-6773. 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 the 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/docs 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.
/L.T.K./Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683