DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment filed 2/27/26. 1-4, 9 ,11-12,16-22, 24, 26 and 28 have been canceled. Claims 29-48 are new and pending.
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 29-48 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.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 38-46 are drawn to a system; claims 29-37 are drawn to a method; claims 47-48 are directed to an article of manufacture (CRM with instructions for performing a method).
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
The United States Patent and Trademark Office (USPTO) has prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The 2019 Revised Patent Subject Matter Eligibility Guidance revises the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas) under Step 2A of the USPTO’s Subject Matter Eligibility Guidance in two ways. First, the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Second, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? If so, is the judicial exception integrated into a practical application of the judicial exception? A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will 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 judicial exception.
In the instant case, claims 29-48 recite(s) a method, product and system for certain methods of organizing human activities, which is subject matter that falls within the enumerated groupings of abstract ideas described in the 2019 Revised Patent Subject Matter Eligibility Guidance. Certain methods of organizing human activities includes fundamental economic practices, like insurance; commercial interactions (i.e. legal obligations, marketing or sales activities or behaviors, and business relations). Organizing human activity also encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) The recited method and system are drawn to evaluating and ranking clinical trials for treatment options. (i.e. managing personal behavior or relationships or interactions)
In particular, the claims recite a method, product and system (Claims 29, 38, and 47) to:
automatically establishing… a subject profile defining the subject according to a plurality of features, wherein establishing a subject profile comprises an automated process by the clinical decision support system to identify and extract clinical data about the subject from the clinical database;
automatically identifying… a set of clinical trials that are relevant to the subject, wherein each clinical trial in the set of relevant clinical trials corresponds to at least one therapy and comprises a plurality of inclusion criteria that are satisfied by features of the plurality of features of the subject profile;
automatically assigning…a weighting score to each of the plurality of therapies corresponding to the identified set of clinical trials, wherein each weighting score is based on at least: (i) a satisfaction score indicating a degree of satisfaction of the inclusion criteria by the plurality of features of the subject profile; (ii) an outcome score indicating an extent to which the clinical trial achieved a clinical benefit; and (iii) a supplemental effect score comprising a measure of one or more known negative side effects associated with the clinical trial, wherein the measure of a known negative side effect comprises one or more of a frequency and severity of the negative side effect;
automatically ranking… the therapies corresponding to the set of clinical trials;
receiving…an adaptation of one or more of the plurality of inclusion criteria for the plurality of clinical trials, wherein the adaptation comprises relaxing an inclusion criterion that excludes the subject from eligibility for at least one of the plurality of clinical trials by modifying the inclusion criterion such that the subject is treated as satisfying the inclusion criterion when the subject fails to meet the inclusion criterion by less than a threshold amount;
automatically re-identifying … based on the received adaptation, a revised set of clinical trials that are relevant to the subject, wherein each clinical trial in the set of relevant clinical trials corresponds to at least one therapy and comprises a plurality of inclusion criteria that are satisfied by features of the plurality of features of the subject profile, and wherein the revised set of clinical trials comprises, due to relaxation of the inclusion criterion, one or more clinical trials that were not previously identified;
automatically assigning… a weighting score to at least the one or more clinical trials that were not previously identified;
automatically ranking, based on the assigned weighting scores, the therapies found within the revised set of clinical trials, wherein the ranking includes one or more therapies from the one or more clinical trials that were not previously identified
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106, subsection III, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Examples of insignificant extra-solution activity include mere data gathering, selecting a particular data source or type of data to be manipulated, and insignificant application.
In the instant case the additional step(s) of: automatically outputting the ranking of the therapies for the subject via a user interface of the clinical decision support system…; automatically outputting the ranking of the therapies for the subject…, wherein the output ranking further comprises, for each ranked therapy, at least one expected benefit of the therapy and at least one potential risk associated with the therapy (2nd time) as recited in claims 29, 38, and 47 amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)
Exemplary claims 29, 38 and 47 also recite additional limitation(s), including: “a processor,“ “a clinical database,” “a clinical trials database comprising information about a plurality of clinical trials each comprising a plurality of inclusion criteria, a corresponding therapy, and outcome data,” and “a user interface.”
Moreover, the generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “The system 100 may comprise a computing device, such as desktop, laptop or tablet computer, a smartphone, a server, a network of computing devices, or any other apparatus or system having suitable processing functionality.” (see PG-pub- par. 32). ” The specification further explains: he processor 102, 604 can comprise one or more processors, processing units, multi-core processors or modules that are configured or programmed to control apparatus and/or the system 100 in the manner described herein. In particular implementations, the processor 102, 604 can comprise a plurality of software and/or hardware modules that are each configured to perform, or are for performing, individual or multiple steps of the method described herein. (par. 68)
Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of the additional (generic) components.
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
Claims 30-37 are dependent from Claim 29, include(s) all the limitations of clam 29. However, the additional limitations of the claims 30-37 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or the additional steps amount to insignificant extra solution activities. Therefore, claim(s) 30-37 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 39-46 are dependent from Claim 38, include(s) all the limitations of claim 38. However, the additional limitations of the claims 39-46 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or the additional steps amount to insignificant extra solution activities. Therefore, claim(s) 39-46 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim 48 is dependent from Claim 47, include(s) all the limitations of clam 47. However, the additional limitations of the claim 47 fails to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or the additional steps amount to insignificant extra solution activities. Therefore, claim(s) 48 is also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Allowable Subject Matter
The prior art rejection has been withdrawn for claims 29-48.
Claims 29, 38 and 47 recite: receiving, via the user interface of the clinical decision support system, an adaptation of one or more of the plurality of inclusion criteria for the plurality of clinical trials, wherein the adaptation comprises relaxing an inclusion criterion that excludes the subject from eligibility for at least one of the plurality of clinical trials by modifying the inclusion criterion such that the subject is treated as satisfying the inclusion criterion when the subject fails to meet the inclusion criterion by less than a threshold amount; and automatically re-identifying, by the clinical decision support system based on the received adaptation, a revised set of clinical trials that are relevant to the subject….
The Petak does not expressly disclose: receiving, via the user interface of the clinical decision support system, an adaptation of one or more of the plurality of inclusion criteria for the plurality of clinical trials, wherein the adaptation comprises relaxing an inclusion criterion that excludes the subject from eligibility for at least one of the plurality of clinical trials by modifying the inclusion criterion such that the subject is treated as satisfying the inclusion criterion when the subject fails to meet the inclusion criterion by less than a threshold amount; and automatically re-identifying… a revised set of clinical trials that are relevant to the subject.
A newly found reference, Hill et al (US 20150073830 A1), discloses adjusting/relaxing inclusion criteria so that previously excluded individuals may be included. (par. 57-60) However, prior art of record does not suggest fairly suggest further modification to the combination to include the teachings of the Hill reference.
Response to Arguments
Applicant's arguments filed 7/1/26 have been fully considered but they are not persuasive.
(A) Applicant argues the claim rejections under 35 USC 112(b).
In response, the claim rejections 36 and 45 have been withdrawn in light of the claim amendments filed on 7/1/26. Applicant’s arguments are moot.
(B) Applicant argues the claim rejections under 35 USC 101, and asserts that the claims are not drawn to “certain methods of organizing human activity…”
In response, the examiner disagrees. As understood by the Examiner, the claimed invention outlines a process by which a patient/subject (or treating physician) can evaluate possible (experimental) treatment options offered by one or more clinical trial studies and rank the options to determine the best fit. Alternatively, claimed invention also defines the process by which a principal investigator evaluates possible subjects against clinical trial criteria, rank treatment options, and determines the best fit or match.
In either case, the claimed invention is drawn to an individual using the claimed process to evaluate/rank a set of options to determine how to best proceed. As such, the claims are properly characterized as organizing human activity which encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.)
Moreover, the applicant’s arguments regarding the claim rejections under 35 USC 101 are unpersuasive, and the matter has been decided in the PTAB decision mailed on 12/31/2025. The additional claim limitations are noted and have been addressed in the current claim rejections. However, insofar as the additional claim limitations recite an iteration of the previously claimed steps recited in claims 1-4, 9, 11-12, 16-22, 24, 26, and 28, the claims are not deemed patent eligible for the reasons set forth in the Examiner’s Answer mailed on 1/23/2025, and in the PTAB decision affirming these rejections, mailed on 12/31/25.
(C) Applicant argues that the claimed invention integrates any abstract idea into a practical application.
In response, the examiner disagrees. The recited judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
(D) Applicant argues that the invention solves a problem in the art and provides an improvement to a technical field and to the functioning of a computer.
In response, the examiner disagrees. Consideration of improvements is relevant to the integration analysis regardless of the technology of the claimed invention. That is, the consideration applies equally whether it is a computer-implemented invention, an invention in the life sciences, or any other technology. See, e.g., Rapid Litigation Management Ltd. v. CellzDirect, Inc., in which the court noted that a claimed process for preserving hepatocytes could be eligible as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural.(See 827 F.3d 1042, 1048 (Fed. Cir. 2016)) Notably, the court did not distinguish between the types of technology when determining that the invention improved technology.
It is important to keep in mind that an improvement in the judicial exception itself (e.g., a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG LLC, the court determined that the claim simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. (921 F.3d 1084, 1093-94 (Fed. Cir. 2019).
Applicant’s argued improvement is to matching subjects to suitable clinical trials, i.e. the abstract idea. As explained on page 14 of the current response: “"it may be difficult for a clinician to remain aware of the various therapeutic options available and suitable for their subjects," and that there is a need for a system enabling a clinician to make a more informed decision about suitable therapies.”
Moreover, in accordance with MPEP 2106.05 (a), if it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.
For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).
An important consideration in determining whether a claim is directed to an improvement in technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other Step 2B considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)). Thus, evaluation of those other considerations may assist examiners in making a determination of whether a claim satisfies the improvement consideration.
Once again, the applicant’s specification fails to provide a technical explanation for the technical improvement. There is no discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.
Conclusion
THIS ACTION IS MADE FINAL. 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 Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached on M-F, 10-6:30.
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, Shahid Merchant can be reached on 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RACHEL L. PORTER
Primary Examiner
Art Unit 3684
/Rachel L. Porter/Primary Examiner, Art Unit 3626
Prosecution Insights