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
Claims 1-22 are pending.
This communication is in response to the communication filed August 5, 2026.
Claim Rejections - 35 USC § 112
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 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 10 recites the limitation "for the selected variation" for which there is insufficient antecedent basis in the claim.
The dependent claims are rejected for their dependency on indefinite claims.
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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite inventions directed to determining trial parameters for a physical experiment for generating instructions for the physical experiment, which are statutory categories of inventions.
Specifically, the independent claims, taking claim 1 as exemplary, recite determining one or more trial parameters for a physical experiment to validate a candidate treatment recommendation, the one or more trial parameters comprising: a duration of the experiment and a number of patients to be enrolled in the physical experiment; for each of one or more variations of the physical experiment, determining, prior to conducting the physical experiment, an effectiveness of the variation in validating the candidate treatment recommendation, the effectiveness describing a likelihood that the physical experiment will provide observable insight regarding an effect of the candidate treatment recommendation on a metabolic state; for the selected variation of the physical experiment satisfying a threshold effectiveness within a threshold trial duration, determining, prior to conducting the physical experiment, one or more metabolic features shared among a cohort of patients sensitive to the candidate treatment recommendation, the sensitivity of a patient representing a likelihood that adjustments to the one or more intervention parameters will affect the metabolic state of the patient; and generating instructions for a medical professional to perform the selected variation of the physical experiment by adjusting the one or more trial parameters according to the selected variation and enrolling patients sharing at least one of the one or more metabolic features.
The claim limitations are interpreted as being grouped within the “certain methods of organizing human activity” grouping of abstract ideas. The limitations are directed to making various determinations for clinical trial parameters to match patients to an experiment and to provide instructions the experiment, which is interpreted as managing human interactions. See MPEP 2106.04. The claims are interpreted to recite concepts relating to tracking or organizing clinical information. Accordingly, the claims recite an abstract idea.
The dependent claim limitations are directed towards describing trial parameters, identifying candidate treatment recommendations, generating shortlist of candidate treatment recommendations, generating variations of the physical experiment, identifying target outcomes, identifying a cohort of patients sensitive to intervention parameters, and using various metabolic features. The dependent claims recite the abstract ideas of the independent claims. The claims are interpreted to recite concepts relating to tracking or organizing clinical information. The claims recite additional elements that are not interpreted as part of the abstract idea, and are addressed below.
The additional elements of the claims include non-transitory computer-readable medium and processors. 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.
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 non-transitory computer-readable medium and the processors may be part of a computer and perform the functions of storing and processing data (specification p. 13-14, 97-98). Moreover, any of the limitations described may be performed or implemented with one or more hardware or software modules, alone or in combination with other devices. In one embodiment, a software module is implemented with a computer program product including a computer-readable non-transitory medium containing computer program code, which can be executed by a computer processor for performing any or all of the steps, operations, or processes described.
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 instructions instead of directly performing a 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 are similar to using a computer to perform repetitive calculations for validations, determining effectiveness, satisfying a threshold, ranking metabolic features, determining a power calculation, determining metabolic features associated with binary values, and determining metabolic features associated with a range of values.
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, the additional elements of using a non-transitory computer readable medium and processors to perform the steps of determining trial parameters, determining an effectiveness of a variation in the physical experiment, determining metabolic features among a cohort of patients, and generating instructions to perform a variation of the physical experiment amount to no more than using computer related devices to automate or implement the abstract idea for determining trial parameters for a physical experiment for generating instructions for the physical experiment.
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 for determining trial parameters for a physical experiment for generating instructions for the physical experiment. 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.
Response to Arguments and Amendments
Applicant’s arguments and amendments filed on 8/5/2026 have been fully considered and are addressed below.
Applicant’s arguments have been fully considered but are not persuasive.
Applicant argues that the amended claims are not directed towards claims that mange human interactions and are instead directed to forward-looking probability computations across patient specific metabolic models (Remarks p. 11). Examiner respectfully disagrees.
The Alice framework requires consideration of whether the claim is “directed to one of those patent-ineligible concepts.” Alice, 573 U.S. at 217. If so, then one must examine “the elements of [the] claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Alice, 573 U.S. at 217 (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 78, 79 (2012)). That is, we examine the claim for an “inventive concept,” “an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself” Alice, 573 U.S. at 217-18 (alteration in original) (quoting Mayo, 566 U.S. at 72-73). The previous Office Action provided the framework of the Alice test and laid out explanations and answers to step 1, 2A prong 1, 2A prong 2, and 2B.
Elements in the claims were explained as involving a series of steps for determining trial parameters for a physical experiment for generating instructions for the physical experiment with a citation to the MPEP 2106.04. Also, the additional elements are not considered when initially determining if the claim is directed to an abstract idea. If the claim is directed to an abstract idea, as noted above, then a determination is made whether the claim has an inventive concept. When analyzing claims to determine if they recite an abstract idea, any portion of the claims reciting any semblance of a mental process or a method of organizing human activity may be used to say that the claims recite an abstract idea.
Applicant’s assertion of the claims being directed to forward-looking probability computations across patient specific metabolic models invoke a recitation of abstract ideas. A combinations of mathematical concepts for probability computations may be used as part of a mental processes that are forward-looking to manage relationships or interactions between doctors and patients. Moreover, the claim limitations are similar to other automated methods that fall within the certain methods of organizing human activity category of abstract ideas. See, e.g., In re Meyer, 688 F.2d 789, 795 (CCPA 1982) (determining that an “invention . . . concerned with replacing, in part, the thinking processes of a neurologist with a computer” is directed to an abstract idea); MPEP § 2106.04(a)(2)(II)(C) (explaining that the claims in Meyer are examples of claims directed to managing human behavior); see also In re Salwan, 681 F. App’x 938, 941 (Fed. Cir. 2017) (determining that a claimed method for transferring patient health information “describes little more than the automation of a ‘method of organizing human activity’ with respect to medical information”); DietGoal Innovations LLC v. Bravo Media LLC, 33 F. Supp. 3d 271, 283 (S.D.N.Y. 2014), affd, 599 F. App’x 956 (Fed. Cir. 2015) (computerized meal planning).
Applicant argues that the claims integrate the recited abstract idea into a practical application, because they recite enabling validation of candidate treatment in a fraction of the time and cost of conventional trials, which is an improvement (p. 11). Examiner respectfully disagrees.
The patent-eligible claims in McRO incorporated specific, limited rules that improved a technological process. See 837 F.3d at 1313-16. In contrast, the claims recite a series of broadly worded, result-oriented functions without meaningfully limiting how the claimed method performs those functions. Moreover, the claims do not improve technology or a technological process. At best, the claims recite an improved method of creating variations of parameters for clinical trials, which is a method of organizing human activity. See Trading Techs. Int’l, Inc. v. IBGLLC, 921 F.3d 1084, 1093 (Fed. Cir. 2019) (“The claims of the ’999 patent do not improve the functioning of the computer, make it operate more efficiently, or solve any technological problem. Instead, they recite a purportedly new arrangement of generic information that assists traders in processing information more quickly.”); Trading Techs. Int’l, Inc. v. IBG LLC, 921 F.3d 1378, 1384 (Fed. Cir. 2019) (“The claims are focused on providing information to traders in a way that helps them process information more quickly, not on improving computers or technology.” (citation omitted)).
The Federal Circuit has indicated that a claim must include more than conventional implementation on generic components or machinery to qualify as an improvement to an existing technology. See, e.g., Affinity Labs of Tex. v. DirecTV, LLC, 838 F.3d 1253, 1264-65, 120 USPQ2d 1201, 1208-09 (Fed. Cir. 2016); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 612-13, 118 USPQ2d 1744, 1747-48 (Fed. Cir. 2016). Here, the invention utilized computers perform the functions of storing and processing data, as stated in pages 13-14, 97-98 of the specification. The claims are therefore not directed to an improvement in computer functionality.
Applicant argues that the previous office action does not provide factual support for supporting that the ordered combination of steps is not well-understood, routine, or conventional (p. 12). Examiner respectfully disagrees.
The USPTO memorandum published in light of Berkheimer v. HP stated on pages 3-4 that examiners may rely on a number of considerations as relevant to the evaluation of whether the claimed additional elements amount to an inventive concept. The list of considerations given in the MPEP 2106.05 for step 2B is not intended to be exclusive or limiting. Additional elements can often be analyzed based on more than one type of consideration and the type of consideration is of no import to the eligibility analysis. However, if examiners state that the additional elements are well-understood, routine, and conventional then, they must cite to an applicant’s specification, court decisions, publications demonstrating the well-understood, routine, conventional nature of elements, or can take official notice. The previous Office Action did not state that the additional elements were well-understood, routine, and conventional citations, and instead stated that the additional elements alone or in combination do not improve the functioning of a computer or any other technology, do not improve another technology or technical field, and does not effect a transformation or reduction of a particular article to a different state or thing.
Examiner respectfully submits that the burden of establishing that the claimed subject matter falls under a judicial exception to patent eligibility has been met, along with a showing of how the additional elements are not significantly more than the judicial exception, therefore the claims remain rejected under 101.
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 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.
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, 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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