DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to a response filed 20 April 2026, on an application filed 20 March 2024, that is a continuation-in-part of an application filed on 18 July 2022 and issued as U.S. Patent 11,942,215.
Claims 1, 10, 20 and 21 have been amended.
Claims 1-21 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 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,942,215. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are effectively contained within the patented claims, as shown herein:
Present Claims U.S. Patent No. 11,942,215
1, 10, 20 1, 11, 21
2, 11 2, 12
3, 12 3, 13
4, 14 4, 15
5, 15 5, 16
6, 16 6, 17
7, 17 7, 18
8, 18 8, 19
9, 19 9, 20
21 10
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1, 10 and 20 recites the limitation the input elements in the first generate limitation. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation will be interpreted to read .
To the extent that other claims rely on claims that are rejected under 35 USC 112 and fail to correct the deficiencies of the claims they rely on, those other claims are rejected for the same reasons as the claims they rely on. Appropriate correction is required.
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 1-21 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.
Step 1
Claims 1-21 are within the four statutory categories. Claims 1-9 and 21 are drawn to an intelligent secure networked system for identifying and correcting a defect in a health care service, which is within the four statutory categories (i.e. machine). Claims 10-19 are drawn to a method for identifying and correcting a defect in a healthcare service, which is within the four statutory categories (i.e. process). Claim 20 is drawn to a non-transitory computer-readable storage medium having embodied thereon instructions, which is within the four statutory categories (i.e. manufacture).
Prong 1 of Step 2A
Claim 1 recites: An intelligent secure networked system for identifying and correcting a defect in a health care service, the system comprising:
a computer processor for processing data;
a storage medium communicatively coupled to the computer processor, the storage medium storing data;
a secure intelligent network communicatively coupled to the computer processor and the storage medium, the secure intelligent network having a deep neural network trained by an evidence engine with evidentiary support including one or more of medical journals, health studies, clinical guidelines, or standards bodies, the deep neural network configured to:
receive a set of data comprising physician-directed health care service data for a previous stress test as coded and unstructured narrative text, and further comprising health care service data as a health care service is being delivered;
adjust for one or more factors having a presence or lacking in claims data, the one or more factors including: undocumented comorbidities, hedging in diagnostic uncertainty, strength of clinical support, ulterior motives and defensive medicine, the presence for each factor of the one or more factors equating to incremental statistical variability that is calculated to a sum, added to a statistical range of better practice, and results in an adjusted range of better practice;
receive a set of metrics associated with appropriateness of a stress test;
apply a weight, bias and threshold, the weight, the bias and the threshold directing an analysis by the deep neural network on the physician-directed health care service data for a stress test;
generate a first output comprising an appropriateness measure for the stress test and a range of better practice, the range of better practice comprising limits of the appropriateness measure, where an appropriateness measures score exceeds an upper limit in a case of overuse of a service that results from operation of the deep neural network on the input elements, or is below a lower limit in a case of underuse of the service;
generate a second output that comprises a rate of inappropriateness of the stress test, the inappropriateness having a numerator representing a number of stress tests with nuclear imaging that occurred within 30 days of an evaluation and management visit to a cardiologist and having a denominator representing stress testing that occurred within 30 days of an evaluation and management visit to a cardiologist, excluding cases with inpatients, outpatients with symptoms of acute coronary syndrome or patients who had a cardiac-related emergency department visit within a thirty-day period;
apply a dynamic feedback communicatively coupling appropriateness measure, the range of better practice, and the rate of inappropriateness of the stress test for the specific health care service for continuous learning of the deep neural network;
updating the set of metrics according to the dynamic feedback as received by the deep neural network;
generate an appropriateness measures score for cardiovascular stress testing; and
generate a cumulative appropriateness practice score to reflect a physician's performance across multiple measures or practice areas.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract ideas of “mathematical concepts” and/or the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case the steps directed to generating an appropriateness score of a physician’s use of cardiovascular stress testing based on historical data), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for claims 10 and 20 are identical as the abstract idea for claims 1, because the only difference between claims 1, 10 and 20 is that claim 1 recites a system method, whereas claim 10 recites a method and claim 20 recites a non-transitory computer-readable media.
Dependent claims 2-8, 11-19 and 21 include other limitations, for example claims 2-13, 12-19 and 21 further indicates what data is used and where data comes from, and claims 8, 9, 18 and 19 indicates data outputs, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 2-8, 11-19 and 21 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2-8, 11-19 and 21 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 10 and 20.
Prong 2 of Step 2A
Claims 1-21 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the deep neural network and the structural components of the computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs 37 and 109 of the present Specification, see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language limiting the data to medical treatment data, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 2-8, 11-19 and 21 include other limitations, but these limitations also amount to no more than mere generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2-8, 11-19 and 21), and/or do not include any additional elements beyond those already recited in independent claims 1, 10 and 20, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1-21 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, neural network and the structural components of the computer), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs 37 and 109 of the Specification discloses that the additional elements (i.e. the structural components of the computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data ) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); 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); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); 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.");
iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log); and
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Dependent claims 2-8, 11-19 and 21 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 10 and 20, and/or the additional elements recited in the aforementioned dependent claims similarly amount to mere generally link the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2-8, 11-19 and 21), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-21 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant’s arguments filed 20 April 2026 concerning the rejection of all claims under 35 U.S.C. 112 have been fully considered and they are persuasive in view of the amendments to the claims. However, new rejections of the claims under 35 U.S.C. 112 have been issued in view of the amendments to the claims.
Applicant’s arguments filed 20 April 2026 concerning the rejection of all claims under 35 U.S.C. 103(a) have been fully considered and they are persuasive in view of the amendments to the claims. Accordingly, the prior art rejection of the claims has been removed.
Applicant’s arguments filed 20 April 2026 concerning the rejection of all claims under 35 U.S.C. 103(a) have been fully considered but they are not persuasive. The prior art of record fails to disclose the current claims.
With regard to the rejection of the claims under 35 USC 101, Applicant argues on pages 10-21 that:
A. “Step 2A, Prong One: Claim 1 as amended is not directed to a judicial exception for a mathematical formula, mental process, or certain methods for organizing human activity” because the claims generate outputs rather than applying outputs.
B. “Step 2A, Prong Two: The claims are specifically tied to a practical solution to a problem unique clinical decision support, and do not merely recite a judicial exception with generic computer components” because “Claim 1 as amended demonstrates a practical application by providing continuous learning of a machine using decision outcomes and historical data, automatically generating an output for better decisions by identifying and correcting a defect in a health care service as it is being delivered” similar to Example 40 of the PEG.
The Office respectfully disagrees. Please see the updated statutory rejection of the claims, issued above, wherein the claims are shown to be directed to an abstract idea without significantly more.
Regarding A., the Office notes that the claims are not shown as being directed to a mental process. They are directed to a mathematical formula and certain methods of organizing human activity as they recite a mathematical formula and a series of rules or instructions to follow. The recited examples are clearly not similar to the claims at issue and are not persuasive.
Regarding B.,
MPEP 2106. 04(a)(2)(11) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Office submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to generate an appropriateness score of a physician’s use of cardiovascular stress testing based on historical data. Furthermore, the Office submits that healthcare itself is inherently represents the organization of human activity. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a series of rules or instructions that a person or persons would follow to steps directed to generating an appropriateness score of a physician’s use of cardiovascular stress testing based on historical data, the claimed invention is directed to an abstract idea. The recitation of the deep neural network is merely additional matter that does not amount to significantly more.
Accoridngly, the rejection is upheld.
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 of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
10 June 2026
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