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 .
Notice to Applicant
This communication is in response to the amendment filed 03/05/2026. Claims 31, 50, 51 have been amended. Claims 31-51 are presented for examination.
Subject Matter Free of Prior Art
Claim(s) 31-51 are allowable over prior art because the prior art of record fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims, in particular: “generating, according to the selected at least one reasoning rule set, at least one hypothesis regarding a correlation among the target objects with respect to an outcome wherein the correlation among the target objects adjusts the concept mapping based on a validity score associated with the at least one hypothesis,” “wherein the at least one hypothesis and the weighted selection of pointers relate to a positive or a negative outcome of a treatment protocol applied to the patient; and recommend or alter an action with respect to the treatment protocol based on the at least one hypothesis, a support status of the at least one hypothesis, and the weighted selection of pointers.” Because the prior art does not teach or disclose the above features in the specific manner and combinations recited in independent claims 31, 50-51, claims 31, 50-51 are hereby deemed to be allowable over prior art. Originally numbered dependent claims 32-49 incorporate the allowable features of originally numbered independent claim 31, through dependency.
However, the claims are still rejected under 101.
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 31-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-43, 46-51 of copending Application No. 17/964,015 (reference application) in view of U.S. Patent App. Pub. No. US 2008/0147584 A1 (hereinafter referred to as "Buss") and U.S. Patent App. Pub. No. US 2008/0052116 A1 (hereinafter referred to as "Iliff"). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward a computer-based patient data analysis engine, comprising: at least one computer-readable memory storing software reasoning instructions; a data interface coupled with at least one sensor associated with a patient; at least one processor coupled with the data interface and the at least one computer- readable memory, and upon execution of the software reasoning instructions performs the following steps: acquiring environmental data associated with the patient and at least partially including sensor data from the at least one sensor acquired via the data interface in accordance with instructions to record in real-time or near real-time changes in one or more characteristics of a body of the patient; recognizing aspects from the environmental data as target objects; selecting, from the at least one computer-readable memory, at least one reasoning rule set as a function of the recognized target objects based on a concept mapping of the recognized target objects to one or more types of reasoning, wherein the concept mapping comprises traversing algorithmic structures or extrapolation paths to the one or more types of reasoning according to attributes of the recognized target objects; generating, according to the selected at least one reasoning rule set, at least one hypothesis regarding a correlation among the target objects with respect to an outcome; and causing an output device to present in real-time or near real-time the at least one hypothesis and at least some environmental data associated with the recognized target objects as relating to the outcome wherein the at least one hypothesis relate to a positive or a negative outcome of a treatment protocol applied to the patient and recommend or alter an action with respect to the treatment protocol.
The aforementioned claims of copending Application No. 17/964,015 do not explicitly recite “wherein the concept mapping comprises traversing algorithmic structures or extrapolation paths selected using pointers to the one or more types of reasoning, wherein selection of the pointers is weighted according to attributes of the recognized target objects” of claim 31 from the present application (App. No. 18/220,754). However, the noted features not present are obvious in view of U.S. Patent App. Pub. No. US 2008/0147584 A1 (hereinafter referred to as "Buss") (Buss: ¶ 0029; ¶ 0034). It would have been prima facie obvious to combine the features of the claims of copending Application No. 17/964,015 with wherein the concept mapping comprises traversing algorithmic structures or extrapolation paths selected using pointers to the one or more types of reasoning, wherein selection of the pointers is weighted according to attributes of the recognized target objects of Buss, with the motivation of “multiple rule representations can be used simultaneously to produce a result” (Buss: ¶ 0029).
The aforementioned claims of copending Application No. 17/964,015 do not explicitly recite “wherein…the weighted selection of pointers relate to a positive or a negative outcome of a treatment protocol applied to the patient and recommend or alter an action with respect to the treatment protocol” of claim 31 from the present application (App. No. 18/220,754). However, the noted features not present are obvious in view of U.S. Patent App. Pub. No. US 2008/0052116 A1 (hereinafter referred to as "Iliff") (Iliff: ¶ 0130; ¶ 0179; ¶ 0199). It would have been prima facie obvious to combine the features of the claims of copending Application No. 17/964,015 with wherein the selection of pointers relate to a positive or a negative outcome of a treatment protocol applied to the patient and recommend or alter an action with respect to the treatment protocol of Iliff, with the motivation of “the latest, best, tested, updated medical services” (Iliff: ¶ 0328).
This is a provisional nonstatutory double patenting rejection.
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 31-51 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. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 31 is drawn to a system which is within the four statutory categories (i.e., machine). Claim 50 is drawn to a system which is within the four statutory categories (i.e., machine). Claim 51 is drawn to a computer program product embedded in a non-transitory computer readable medium which is within the four statutory categories (i.e., manufacture).
Independent claim 31 (which is representative of independent claims 50-51) recites… acquire…environmental data associated with the patient and at least partially including sensor data… wherein the sensor data records real-time or near real-time changes in a body of the patient; recognize aspects from the environmental data as target objects including real- time changes in the patient's body recorded by the at least one remote biometric sensor; select…at least one reasoning rule set as a function of the recognized target objects based on a concept mapping of the recognized target objects to one or more types of reasoning, wherein the concept mapping comprises traversing algorithmic structures or extrapolation paths selected using pointers to the one or more types of reasoning, wherein selection of the pointers is weighted according to attributes of the recognized target objects including the real-time recorded changes in the patient's body; generate, according to the selected at least one reasoning rule set, at least one hypothesis regarding a correlation among the target objects with respect to an outcome; upon the weighted selection of the pointers meeting one or more criteria in the validation plan…the sensor data is acquired…to determine whether the at least one hypothesis is supported or not supported; …present in real-time or near real-time the at least one hypothesis and at least some environmental data associated with the recognized target objects as relating to the outcome wherein the at least one hypothesis and the selection of pointers relate to a positive or a negative outcome of a treatment protocol applied to the patient; and recommend or alter an action with respect to the treatment protocol based on the at least one hypothesis and the selection of pointers.
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. That is, other than reciting a “processor” (claims 31, 50), the claim encompasses rules or instructions followed to collect and analyze a patient’s environmental data and output a recommendation to improve the patient’s conditions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 31 recites additional elements (i.e., a computer-based remote patient data monitoring engine; at least one computer-readable memory storing rules engine software instructions; a data interface; at least one remote biometric sensor; wherein the sensor data records real-time or near real-time changes in one or more characteristics of a body of the patient; at least one processor; a network; capturing sensor data from one or more biometric sensors associated with one or more other patients; an output device). Claim 50 recites additional elements (i.e., A computer-readable memory (CRM) storing rules engine software instructions; at least one processor; a network; at least one remote biometric sensor; wherein the sensor data records real-time or near real-time changes in one or more characteristics of a body of the patient; a data interface; capturing sensor data from one or more biometric sensors associated with one or more other patients; an output device). Claim 51 recites additional elements (i.e., a network; at least one remote biometric sensor; wherein the sensor data records real-time or near real-time changes in one or more characteristics of a body of the patient; a data interface; at least one computer-readable memory; capturing sensor data from one or more biometric sensors associated with one or more other patients; an output device). Looking to the specifications, a computer engine having at least one computer-readable memory storing instructions, a data interface, at least one processor, output device on a network is described at a high level of generality (¶ 0017; ¶ 0021; ¶ 0031; ¶ 0036; ¶ 0049), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, “at least one remote biometric sensor… wherein the sensor data records real-time or near real-time changes in one or more characteristics of a body of the patient” and “capturing sensor data from one or more biometric sensors associated with one or more other patients” is described at a high level of generality, such that biometric sensors are invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., measuring and providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a computer engine having at least one computer-readable memory storing instructions, a data interface, at least one processor, output device on a network) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, “at least one remote biometric sensor… wherein the sensor data records real-time or near real-time changes in one or more characteristics of a body of the patient” is described at a high level of generality, such that it is invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., measuring and providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 32-49 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 33-41, 44-49 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claim 32 further recites the additional elements of “a virtual machine,” which the specification seems to describe at a high level of generality as an example of “cloud-based services” (¶ 0049). Per broadest reasonable interpretation in light of the specification, it amounts to no more than mere instructions to apply the exception using generic computer components. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claims 42-43 further recites the additional elements of “a knowledge base storing object information for known target objects,” which is described at a high level of generality, such that it only invokes the knowledge base merely as a tool in its ordinary capacity to perform an existing process (i.e., storing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Certain Methods of Organizing Human Activity,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Response to Arguments
Applicant's arguments filed 03/05/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 03/05/2026.
In the remarks, Applicant argues in substance that:
Regarding the 101 rejections,
“The amended limitations of claim 31 are clearly directed to a particular solution to the problem of patients needing prompt validated diagnosis and treatment of medical conditions, and the need to interpret biometric sensor data capturing for patients to rapidly diagnose and treat the patient's medical conditions. The technical operations set forth in claim 31 as currently amended generate and provide the hypotheses relating to patient health status, potential diagnoses, and/or potential patient outcomes. The generated hypotheses are formulated in real-time or near real-time to data recording and acquisition, and are based on acquiring environmental data associated with a patient and at least partially including real-time biometric sensor data from the at least one sensor acquired via a data interface… See July 2024 Subject Matter Eligibility Examples, Example 49. The limitations of Applicant's claim 31 imposes meaningful limits on a concept; namely, performing real-time automated diagnosis and alteration of treatment protocols for patients more accurately based on analysis of real-time medical data captured by biometric sensors of the patient… the claims are directed to identify a medical condition of the patient and recommend and/or alter treatment protocols and/or surgeries to improve health outcomes… Claim 31 as amended specifically recites that particular medical treatment (e.g., treatment protocol) is administered, where the particular medical treatment is recommended, changed or altered based on a hypothesis and an associated validity score generated from a reasoning rule set and a concept mapping based on the analysis of environmental data (e.g., real-time biometric data measuring changes in the patient's body). The claimed invention generates based on a real-time analysis of biometric data, a specific treatment for a medical condition such that the claim as a whole integrates the judicial exception into a practical application”; and
“Applicant's claim limitations as set forth above are not well-understood, routine, or conventional in the field… The limitations of claim 31 are recited with a high degree of specificity and integrate the claims into the practical application. On page 7 of the Office Action, for example, the Examiner erroneously alleges that the use of a general-purpose computer and a biometric sensor amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea. Contrary to the Examiner's assertions, the technical inventive aspects of the Applicant's invention involve the specific computational analysis of medical data set forth in the limitations of Applicant's claim 31 as currently amended… according to the USPTO's Berkheimer Memorandum, an additional element (or combination of elements) should not be deemed conventional unless the Examiner supports a rejection… Claim 31 includes elements that represent an inventive concept, as evidenced by the Examiner's own finding that the claims are deemed free of prior art. Claim 31 as set forth above contains detailed limitations that furthermore automatically improves the automated patient data analysis engine that it implements.”
It is respectfully submitted that Examiner has considered Applicant’s arguments and does not find them persuasive. Examiner has attempted to address all of the arguments presented by Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
In response to Applicant’s argument that (a) regarding the 101 rejections,
“The amended limitations of claim 31 are clearly directed to a particular solution to the problem of patients needing prompt validated diagnosis and treatment of medical conditions, and the need to interpret biometric sensor data capturing for patients to rapidly diagnose and treat the patient's medical conditions. The technical operations set forth in claim 31 as currently amended generate and provide the hypotheses relating to patient health status, potential diagnoses, and/or potential patient outcomes. The generated hypotheses are formulated in real-time or near real-time to data recording and acquisition, and are based on acquiring environmental data associated with a patient and at least partially including real-time biometric sensor data from the at least one sensor acquired via a data interface… See July 2024 Subject Matter Eligibility Examples, Example 49. The limitations of Applicant's claim 31 imposes meaningful limits on a concept; namely, performing real-time automated diagnosis and alteration of treatment protocols for patients more accurately based on analysis of real-time medical data captured by biometric sensors of the patient… the claims are directed to identify a medical condition of the patient and recommend and/or alter treatment protocols and/or surgeries to improve health outcomes… Claim 31 as amended specifically recites that particular medical treatment (e.g., treatment protocol) is administered, where the particular medical treatment is recommended, changed or altered based on a hypothesis and an associated validity score generated from a reasoning rule set and a concept mapping based on the analysis of environmental data (e.g., real-time biometric data measuring changes in the patient's body). The claimed invention generates based on a real-time analysis of biometric data, a specific treatment for a medical condition such that the claim as a whole integrates the judicial exception into a practical application”:
It is respectfully submitted that Applicant argues “a particular solution to the problem of patients needing prompt validated diagnosis and treatment of medical conditions, and the need to interpret biometric sensor data capturing for patients to rapidly diagnose and treat the patient's medical conditions. The technical operations set forth in claim 31 as currently amended generate and provide the hypotheses relating to patient health status, potential diagnoses, and/or potential patient outcomes. The generated hypotheses are formulated in real-time or near real-time to data recording and acquisition, and are based on acquiring environmental data associated with a patient and at least partially including real-time biometric sensor data from the at least one sensor acquired via a data interface.” However, the claim limitations which to which Applicant refer as “generate and provide the hypotheses relating to patient health status, potential diagnoses, and/or potential patient outcomes. The generated hypotheses are formulated in real-time or near real-time to data recording and acquisition, and are based on acquiring environmental data associated with a patient and at least partially including real-time biometric sensor data” are interpreted as part of the rules or instructions followed to collect and analyze a patient’s environmental data and output a recommendation to improve the patient’s conditions, which is the abstract idea, but for the recitation of generic computer components. The “sensor” is interpreted as an additional element, which is described at a high level of generality, such that it is invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., measuring and providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. The “data interface” is described at a high level of generality, such that it amounts to no more than mere instructions to apply the exception using generic computer components. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Even if the claimed invention provided “a particular solution to the problem,” any alleged improvement is at best, an improvement to the abstract idea. However, an improved abstract idea is still an unpatentable abstract idea.
Applicant argues “See July 2024 Subject Matter Eligibility Examples, Example 49” and “particular medical treatment (e.g., treatment protocol) is administered, where the particular medical treatment is recommended, changed or altered based on a hypothesis and an associated validity score generated from a reasoning rule set and a concept mapping based on the analysis of environmental data (e.g., real-time biometric data measuring changes in the patient's body). The claimed invention generates based on a real-time analysis of biometric data, a specific treatment for a medical condition such that the claim as a whole integrates the judicial exception into a practical application.” However, the claim limitations of the present invention are different from the claim limitations of those found eligible in Example 49. Even if the claim limitations of the present invention are similar to that of the claims found eligible (and they are not similar), the claimed inventions are fundamentally different in scope and should be interpreted based on the asserted fact patterns; other fact patterns may have different eligibility outcomes, as is the case with the claims of the present invention. Unlike the claims found eligible in Example 49, the claims of the present invention do not actively recite the treatment of a patient, let alone a “particular treatment.” Furthermore, it is noted that the features upon which applicant relies (i.e., “particular medical treatment (e.g., treatment protocol) is administered”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Regardless, the claim limitations to which Applicant seems to refer (i.e., “recommending changes to or altering the behavior of the treatment protocol based on the at least one hypothesis, the support status of the at least one hypothesis, and the validity score”) are interpreted as part of the rules or instructions followed to collect and analyze a patient’s environmental data and output a recommendation to improve the patient’s conditions, which is the abstract idea, and not additional elements to be interpreted in Step 2A, Prong Two.
Applicant argues “The limitations of Applicant's claim 31 imposes meaningful limits on a concept; namely, performing real-time automated diagnosis and alteration of treatment protocols for patients more accurately based on analysis of real-time medical data captured by biometric sensors of the patient… the claims are directed to identify a medical condition of the patient and recommend and/or alter treatment protocols and/or surgeries to improve health outcomes.” However, the claim limitations which to which Applicant refer as “performing real-time automated diagnosis and alteration of treatment protocols for patients more accurately based on analysis of real-time medical data… identify a medical condition of the patient and recommend and/or alter treatment protocols and/or surgeries to improve health outcomes” are interpreted as part of the rules or instructions followed to collect and analyze a patient’s environmental data and output a recommendation to improve the patient’s conditions, which is the abstract idea, but for the recitation of generic computer components. The “sensor” is interpreted as an additional element, which is described at a high level of generality, such that it is invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., measuring and providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually.
Examiner cannot find any problem caused by the technological environment to which the claims are confined, which per broadest reasonable interpretation of the claim in light of the specification, is a well-known, general purpose computer. The computing system did not cause the argued problem and thus it is not a technical problem caused by the technological environment to which the claims are confined. While the specification need not explicitly set forth the improvement, the disclosure does not provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing any technical improvement or any physical improvement to the computer. See MPEP § 2106.04(d)(1) and 2106.05(a).
Thus, the claims are directed to an abstract idea and the claim as a whole does not integrate the recited judicial exception into a practical application.
“Applicant's claim limitations as set forth above are not well-understood, routine, or conventional in the field… The limitations of claim 31 are recited with a high degree of specificity and integrate the claims into the practical application. On page 7 of the Office Action, for example, the Examiner erroneously alleges that the use of a general-purpose computer and a biometric sensor amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea. Contrary to the Examiner's assertions, the technical inventive aspects of the Applicant's invention involve the specific computational analysis of medical data set forth in the limitations of Applicant's claim 31 as currently amended… according to the USPTO's Berkheimer Memorandum, an additional element (or combination of elements) should not be deemed conventional unless the Examiner supports a rejection… Claim 31 includes elements that represent an inventive concept, as evidenced by the Examiner's own finding that the claims are deemed free of prior art. Claim 31 as set forth above contains detailed limitations that furthermore automatically improves the automated patient data analysis engine that it implements”:
Applicant argues “The Applicant's claim limitations as set forth above are not well-understood, routine, or conventional in the field.” However, per MPEP § 2106.05(I)(A), evaluating whether a claim limitation is “well-understood, routine, conventional activity” is not a standalone test for determining eligibility, but only one consideration “For Evaluating Whether Additional Elements Amount To An Inventive Concept.”
Applicant argues “the Examiner erroneously alleges that the use of a general-purpose computer and a biometric sensor amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea. Contrary to the Examiner's assertions, the technical inventive aspects of the Applicant's invention involve the specific computational analysis of medical data set forth in the limitations of Applicant's claim 31 as currently amended.” However, Applicant fails to specify how “the use of a general-purpose computer and a biometric sensor amounts to…more than mere instructions to apply the exception using generic computer components.” Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually.
Applicant argues “according to the USPTO's Berkheimer Memorandum, an additional element (or combination of elements) should not be deemed conventional unless the Examiner supports a rejection.” However, Examiner did not assert any of the claim limitations were well-understood, routine, conventional activity in Office Action dated 12/05/2025 or above, and thus, no evidence per Berkheimer is required.
Applicant argues “Claim 31 includes elements that represent an inventive concept, as evidenced by the Examiner's own finding that the claims are deemed free of prior art.” However, per MPEP § 2106.05(I): “the search for an inventive concept should not be confused with a novelty or non-obviousness determination…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 § 101 categories of possibly patentable subject matter…a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty…Because [novelty and obviousness] are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101.”
Applicant argues “Claim 31 as set forth above contains detailed limitations that furthermore automatically improves the automated patient data analysis engine that it implements.” However, the courts have indicated that “Mere automation of manual processes” may not be sufficient to show an improvement in computer functionality. See: MPEP § 2106.05(a)(I).
Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Thus, Examiner maintains the 101 rejections of claims 31-51, which have been updated to address Applicant’s remarks and to comply with the 2019 Revised Patent Subject Matter Eligibility Guidance and the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence in the above Office Action.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571)272-8317. The examiner can normally be reached on M-Th 8-5 PM.
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/EMILY HUYNH/Primary Examiner, Art Unit 3683
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