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 .
Response to Election/Restriction
Applicant amended the pending claims as follows:
Claims 1-3, 12 and 23 have been canceled. Claims 4, 6, 8, 10-11, 14-16, 18-21 have been amended. New claims 25-26 have been added. Claims 4-11, 13-22 and 24-26 are pending in the application.
Applicant’s election with traverse of claims 8 and 18 in the reply filed on 01/30/2026 is acknowledged. The traversal is on the ground(s) that there is no serious burden for the Examiner to conduct search and examination of all species in the current application.
This is not found persuasive because one claim recites limitations disclosed for a first species but not for others, while other claims recite limitations disclosed only for each other species. For instance, Species 3 requires natural language processing, which is not required in Species 5: dispensing arrangements; and Species 2 requires generating and executing smart contracts, which is not required in Species 5. Thus, the species are mutually exclusive and have acquired a separate status in the art as shown by their different classification. The different classification requires a separate field of search for each invention. Therefore, it would be a serious burden for the Examiner to prosecute both inventions at the same time.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Claims 4-7, 9-11, 13-17, 19-22 and 24-25 are withdrawn from consideration.
Further, new claim 26 includes limitations of non-elected Species 3, and, therefore, have been withdrawn by the Examiner from the consideration.
Claims 4, 8, 14 and 18 have been examined in this application. This communication is the first action on the merits.
Information Disclosure Statement
The information disclosure statement filed 01/30/2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609.01(B)(2)(3), because the copies of each cited foreign patent document and non-patent literature publication, and a concise explanation of the relevance and a written English translation of a non-English language document, or portion thereof, are not provided. Therefore, foreign patent documents and non-patent literature has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claims 4 and 14 are objected to because the claims use excessive alternative language.
For example, claim 4 recites (emphasis added):
4. A computer-implemented method for analyzing healthcare data, comprising:
obtaining healthcare and economic data about a subject comprising one or more of: an output of a diagnostic or therapeutic device used to diagnose or treat the subject, a result or outcome of a medical procedure completed on or by the subject, a prescription, a medication, a medical item, an insurance, and a payment;
using the healthcare data to:
(1) calculate a statistical probability that an immediate or future adverse change in a health or an economic condition of the subject or a population that includes the subject will require a current or a future medical treatment involving at least a portion of the medication, the medical item, or a healthcare order or plan immediately or during a future time period; and
(2) input the healthcare data to a machine learning model that classifies a current or a future health or economic risk for the subject that requires a current or a future medical treatment involving the at least a portion of the medication, the medical item, or the healthcare order or plan, wherein the healthcare order or plan is received from a healthcare provider or from an output of an artificial intelligence model;
storing a digital asset or a digital twin, wherein:
the digital asset comprises the subject's healthcare data, the calculated future adverse change in health or economic condition or the machine learning classification of the current or future health or economic risk, information about the future medical treatment, and information about the medication, the medical item, or the healthcare order or plan;
the digital twin comprises a virtual representation of the medical procedure completed on or by the subject or the diagnostic or therapeutic device used to diagnose or treat the subject;
the storing comprises using one or more of a distributed ledger, a blockchain, or a database; and the digital asset or the digital twin is owned by the subject or is assigned to another party.
Examiner notes that the search and examination of claim using such alternative language often consume a disproportionate amount of Office resources as compared to other types of claims, because determining the patentability of these claims often requires a separate examination of each of the alternatives within the claims. The Office expects that requiring applicants who choose to draft claims that read on multiple species using alternative language to maintain a certain degree of relatedness among the alternatives will enable the Office to do a more thorough and more reliable examination of such claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4, 8, 14 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. See MPEP § 2161.01. Specifically, for software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP § § 2161.01, 2163.02, and 2181 (IV). It is not enough that one skilled in the art could write a program to achieve the claimed function, because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See MPEP § 2161.01 (citing Vasudevan Software, Inc. V. MicroStrategy, Inc., 782 F.3d 671, 681-683 (Fed. Cir. 2015)).
Claim 4 recites the phrase "the digital twin comprises a virtual representation of the medical procedure completed on or by the subject or the diagnostic or therapeutic device used to diagnose or treat the subject”. However, the specification lacks sufficient support in the disclosure for what computer components and/or rules/algorithms (e.g., the necessary steps and/or flowcharts) that perform the claimed functions in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. While the specification uses a “the digital twin” phrase, there is no disclosure as to what the “digital twin” is and how said software operate to achieve the end result of a digital representation subject as recited in the claim. As such claim 4 is rejected under 12(a) for failing to comply with the written description requirement. Same rationale is applied to the remaining claims.
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.
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.
Claims 4, 8, 14 and 18 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.
A preamble of the independent method claim 4 indicates, that the method is directed to analyzing healthcare data; however, the body of the claim recites the limitations of “analyzing …economic data”, considering “economic condition” or “economic risk”, which is confusing. It is unclear how the economic data or economic risk represent healthcare data of a subject. Further, the claim recites: “(1) calculate a statistical probability that an immediate or future adverse change in a health or an economic condition of the subject or a population that includes the subject will require a current or a future medical treatment…”, “(2) input the healthcare data to a machine learning model that classifies a current or a future health or economic risk for the subject that requires a current or a future medical treatment involving the at least a portion of the medication, the medical item, or the healthcare order or plan, wherein the healthcare order or plan is received from a healthcare provider or from an output of an artificial intelligence model.” Neither the claim nor the Specification explain how calculating economic risk reflects healthcare data of the subject. Thus, the scope of the claim is unclear. Same rationale is applied to remaining 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 4, 8, 14 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
In determining whether a claim falls within an excluded category, the Examiner is guided by the Court’s two-part framework, described in Mayo and Alice. Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)); Bilski v. Kappos, 561 U.S. 593, 611 (2010); 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019); the October 2019 Update of the 2019 Revised Guidance (Oct. 17, 2019); 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (July 17, 2024), and the USPTO’s Paten Subject Matter Eligibility Memorandums of August 4, 2025 and December 5, 2025.
Step 1
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability (i.e., laws of nature, natural phenomena, and abstract ideas). Alice Corp. v. CLS Bank Int'l, 573 U. S. ____ (2014).
Claim 4 is directed to a statutory category, because a series of steps for analyzing healthcare data satisfies the requirements of a process (a series of acts).
The broadest reasonable interpretation of claim 14 encompasses a computer system (e.g., hardware such as a processor and memory) that implements the recited functions. If assuming that the system comprises a device or set of devices, then the system is directed to a machine, which is a statutory category of invention.
(Step 1: Yes).
Next, the claim is analyzed to determine whether it is directed to a judicial exception.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more of analyzing healthcare data. The claim recites:
4. A computer-implemented method for analyzing healthcare data, comprising:
obtaining healthcare and economic data about a subject comprising one or more of: an output of a diagnostic or therapeutic device used to diagnose or treat the subject, a result or outcome of a medical procedure completed on or by the subject, a prescription, a medication, a medical item, an insurance, and a payment;
using the healthcare data to:
(1) calculate a statistical probability that an immediate or future adverse change in a health or an economic condition of the subject or a population that includes the subject will require a current or a future medical treatment involving at least a portion of the medication, the medical item, or a healthcare order or plan immediately or during a future time period; and
(2) input the healthcare data to a machine learning model that classifies a current or a future health or economic risk for the subject that requires a current or a future medical treatment involving the at least a portion of the medication, the medical item, or the healthcare order or plan, wherein the healthcare order or plan is received from a healthcare provider or from an output of an artificial intelligence model;
storing a digital asset or a digital twin, wherein:
the digital asset comprises the subject's healthcare data, the calculated future adverse change in health or economic condition or the machine learning classification of the current or future health or economic risk, information about the future medical treatment, and information about the medication, the medical item, or the healthcare order or plan;
the digital twin comprises a virtual representation of the medical procedure completed on or by the subject or the diagnostic or therapeutic device used to diagnose or treat the subject;
the storing comprises using one or more of a distributed ledger, a blockchain, or a database; and the digital asset or the digital twin is owned by the subject or is assigned to another party.
The limitations of obtaining data; calculating a probability of a medical treatment;
using AI/ML for classifying a health risk; and storing data, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind, which may be practically performed in the human mind using observation, evaluation, judgment, and opinion (MPEP 2106.04(a)(2), subsection III), and/or certain methods of organizing human activity, such as commercial or legal interactions and/or following rules or instructions, but for the recitation of generic computer components. (Note: Examiner’s language (e.g. “obtaining data”; “calculating a probability of a medical treatment”; etc.) is an abbreviated reference to the detailed claim steps and is not an oversimplification of the claim language; the Examiner employing such shortcuts (that refer to more specific steps) when attempting to explain the rejection). That is, other than reciting “by a processor,” nothing in the claim element precludes the step from practically being performed in the mind, and/or performed as organized human activity. Aside from the general technological environment (addressed below), it covers purely mental concepts and/or certain methods of organizing human activity processes, and the mere nominal recitation of a generic network appliance (e.g. an interface for inputting or outputting data, or generic network-based storage devices and displays) does not take the claim limitation out of the mental processes and/or certain methods of organizing human activity grouping.
Specifically, the utilizing statistical tools to process data and to output the estimated values - said functions could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., mental comparison regarding a sample or test subject to a control or target data in Ambry, Myriad CAFC, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) (Grams)). In Grams, the recited functions require obtaining data or patient information (from sensors), and analyze that data to ascertain the existence and identity of an abnormality or estimated responses, and possible causes thereof. And the step of utilizing blockchain protocols to verify and record data represents a well-known proof-of-work algorithm to record a public history of transactions, which is similar to the algorithm for converting binary-coded decimal numerals into pure binary form in Benson (Gottschalk v. Benson, 409 U.S. 63, 65, 93 S.Ct. 253, 254, 34 L.Ed.2d 273 (1972). While said functions are performed by a computer, they are in essence a mathematical algorithm, in that they represent "[a] procedure for solving a given type of mathematical problem." Gottschalk v. Benson, 409 U.S. 63, 65, 93 S.Ct. 253, 254, 34 L.Ed.2d 273 (1972). Moreover, the Federal Circuit has held, “without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.” Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Here, the claimed subject matter is directed to the abstract idea of manipulating existing information (e.g., “healthcare and economic data about a subject”) to generate additional information (e.g., “the calculated future adverse change in health or economic condition”). See id. Further, “analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, [are] essentially mental processes within the abstract-idea category.” Elec. Power, 830 F.3d at 1354; see also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir. 2016). “[T]he fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.” Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).
As per the use of artificial intelligence and/or machine learning techniques (AI/ML), said recitation does not make the claim patent eligible, because said tools are utilized merely for data gathering and comparing, and are not utilized in express manipulation and control of functional aspects and/or hardware components/equipment of real-world processes and systems using output of AI models (e.g., manufacturing processes and equipment, medical treatments, communications processes and systems, logistics systems and hardware, interactive smart phone apps, etc.).
It is similar to other abstract ideas held to be non-statutory by the courts. See, also, Recentive Analytics, Inc. v. Fox Corp. (Fed. Cir. 2025), wherein the court noted that "iterative training," a claimed feature, was inherent to all machine learning models and thus did not confer eligibility. Additionally, applying machine learning to the calculated future adverse change in health or economic condition, an activity predating computers, did not transform the abstract idea into a patent-eligible invention.
Further, the claim is analogous to claims in Content Extraction & Transmission LLC v. Wells Fargo Bank, National Ass’n, Nos. 13-1588,-1589, 14-1112, -1687 (Fed. Cir. Dec. 23, 2014), which were generally directed to “the abstract idea of 1) collecting data, 2) recognizing certain data within the collected data set, and 3) storing that recognized data in a memory.” Slip op. at 7. The Court explained that ”[t]he concept of data collection, recognition, and storage is undisputedly well-known,” and noted that “humans have always performed these functions.” Id. The Court then rejected CET’s argument that the claims were patent eligible because they required hardware to perform functions that humans cannot, such as processing and recognizing the stream of bits output by the scanner. Comparing the asserted claims to “the computer-implemented claims in Alice,” the Court concluded that the claims were “drawn to the basic concept of data recognition and storage,” even though they recited a scanner.
It is similar to other abstract ideas held to be non-statutory by the courts. See, also, Mayo Collaborative Svcs. v. Prometheus Labs. 566 U.S. __, 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012), - Optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders; Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363 (Fed. Cir. 2015)—tailoring sales information presented to a user based on, e.g., user data and time data; TLI Communications LLC v. AV Automotive LLC 823 F.3d 607, 118 U.S.P.Q.2d 1744 (Fed. Cir. 2016) - recording, transmitting and administering digital images; DataTreasury Corp. v. Fidelity National Information Services 669 Fed. Appx. 572 (Fed. Cir. 2016) - remote image capture with centralized processing and storage; RecogniCorp LLC v. Nintendo Co. 855 F.3d 1322, 122 U.S.P.Q.2d 1377 (Fed Cir. 2017) - encoding and decoding image data; Intellectual Ventures I LLC v. Erie Indemnity Co. 850 F.3d 1315, 121 U.S.P.Q.2d 1928 (Fed Cir. 2017) - mobile interface for accessing remotely stored documents, and retrieving data from a database using an index of XML tags and metafiles.
As per receiving, storing and outputting data limitations, it has been held that “As many cases make clear, even if a process of collecting and analyzing information is ‘limited to particular content’ or a particular ‘source,’ that limitation does not make the collection and analysis other than abstract.” SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1168 (Fed. Cir. 2018) (citation omitted); see also In re Jobin, 811 F. App’x 633, 637 (Fed. Cir. 2020) (claims to collecting, organizing, grouping, and storing data using techniques such as conducting a survey or crowdsourcing recited a method of organizing human activity, which is a hallmark of abstract ideas).
All these cases describe the significant aspects of the claimed invention, albeit at another level of abstraction. See Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240-41 (Fed. Cir. 2016) ("An abstract idea can generally be described at different levels of abstraction. As the Board has done, the claimed abstract idea could be described as generating menus on a computer, or generating a second menu from a first menu and sending the second menu to another location. It could be described in other ways, including, as indicated in the specification, taking orders from restaurant customers on a computer.").
Therefore, if a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” and/or “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. (Step 2A – Prong 1: Yes).
Step 2A – Prong 2
In Prong Two, the Examiner determines whether claim 4, as a whole, recites additional elements that integrate the judicial exception into a practical application of the exception, i.e., whether the additional elements 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 no more than a drafting effort designed to monopolize the judicial exception. See Guidance, 84 Fed. Reg. at 54-55. If the additional elements do not integrate the judicial exception into a practical application, then the claim is directed to the judicial exception. See id., 84 Fed. Reg. at 54. “An additional element [that] reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field” is indicative of integrating a judicial exception into a practical application. See Guidance, 84 Fed. Reg. at 55.
The Examiner determined that this judicial exception is not integrated into a practical application, because there are no meaningful limitations that transform the exception into a patent eligible application. In particular, the claim recites additional elements – using a processor to perform the steps of obtaining data; calculating a probability of a medical treatment; using AI/ML for classifying a health risk; and storing data. However, the processor in each step is recited (or implied) at a high level of generality, i.e., as a generic processor performing a generic computer functions of processing data, including receiving, storing, comparing, and outputting data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. See MPEP 2106.05(f). The processor that performs the recited steps merely automates these steps which can be done mentally or manually. Thus, while the additional elements have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." The claim only manipulates abstract data elements into another form, and does not set forth improvements to another technological field or the functioning of the computer itself and, instead, uses computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above.
Further, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, - their collective functions merely provide conventional computer implementation. None of the additional elements "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
The recited steps do not control or improve operation of a machine (MPEP 2106.05(a)), do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)), and do not apply the judicial exception with, or by use a particular machine (MPEP 2106.05(b)), but, instead, require receiving, storing, comparing and outputting data.
Regarding the use of AI/ML techniques, said steps are nothing more than an attempt to recycle preexisting AI/ML technologies to apply for a particular computing application. There are no improvements in said AI/ML techniques, such as advances in the field of computer science itself, or designing a new neural network, and there is no controlling of a technological process using the outcome of said AI/ML operations.
Thus, the use of a trained machine learning model does not integrate the abstract idea of limitation into a practical application, because, under its broadest reasonable interpretation when read in light of the specification, the “estimating a duration and a probability” encompasses mental processes practically performed in the human mind by observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. Similar to Recentive Analytics, claim 4 recites conventional machine learning models without specific improvements to the technology itself. The court noted that "iterative training," a claimed feature, was inherent to all machine learning models and thus did not confer eligibility. Claim 4 does not articulate "how" a technological improvement is achieved.
As per receiving, storing and/or outputting data limitations, these recitations amount to mere data gathering and/or outputting, is insignificant post-solution or extra-solution component and represents nominal recitation of technology. Insignificant "post-solution” or “extra-solution" activity means activity that is not central to the purpose of the method invented by the applicant. However, “(c) Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility”. See Bilski, 138 S. Ct. at 3230 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, ___ (1978)). Thus, claim drafting strategies that attempt to circumvent the basic exceptions to § 101 using, for example, highly stylized language, hollow field-of-use limitations, or the recitation of token post-solution activity should not be credited. See Bilski, 130 S. Ct. at 3230.
Therefore, claim 4 as a whole, outputs only data structure, - everything remains in the form of a code stored in the computer memory. Accordingly, even in combination, these 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. Therefore, the claim is directed to an abstract idea. (Step 2A – Prong 2: No).
Step 2B
If a claim has been determined to be directed to a judicial exception under revised Step 2A, examiners should then evaluate the additional elements individually and in combination under Step 2B to determine whether the provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself).
The Examiner determined that the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the steps of obtaining data; calculating a probability of a medical treatment; using AI/ML for classifying a health risk; and storing data amount to no more than mere instructions to apply the exception using a generic computer component. The claim is now re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field.
The method would require a processor and memory in order to perform basic computer functions of receiving information, storing the information in a database, retrieving information from the database, comparing data, and outputting said information. These components are not explicitly recited and therefore must be construed at the highest level of generality. Based on the Specification, the invention utilizes conventional sensors, communication networks and generic processors, which can be found in mobile devices or desktop computers, conventional memory and display devices, and the functions performed by said generic computer elements are basic functions of a computer - performing a mathematical operation, receiving, storing, comparing and outputting data - have recognized by the courts as routine and conventional activity. Specifically, regarding the recited functions, MPEP 2106.05(d)(II) defines said functions as routine and conventional, or as insignificant extra-solution activity:
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.”); collecting and comparing known information in Classen 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
iii. Electronic recordkeeping, Alice Corp., 134 S. Ct. at 2359, 110 USPQ2d at 1984 (creating and maintaining “shadow accounts”); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log);
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;
v. Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
vi. A web browser’s back and forward button functionality, Internet Patent Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015).
Regarding training and/or re-training a neural model, and obtaining data via repetitive operation of the neural model, said steps are nothing more than an attempt to recycle preexisting AI/ML technologies to apply for a health risk classifying application. There are no improvements in said AI/ML techniques, such as advances in the field of computer science itself, or designing a new neural network, and there is no controlling of a technological process using the outcome of said AI/ML operations. Claim 4 neither specifies a specific technical purpose for which the method is used, nor the claim defines a specific technical implementation of the method, nor the claimed method is particularly adapted for that implementation in that its design is motivated by technical considerations of the internal functioning of the computer. Said AI/ML algorithms and computations are done inside of a computer, and do not have a real-world impact and are not tied to the functionality of the computer. Further, there is no evidence that the invention lies in the training phase or execution phase or both; said AI/ML recitation represents merely conventionally applying an existing model to an existing data from publicly accessible databases, with the result being not technological, but purely entrepreneurial. Similar to Recentive Analytics, Inc. v. Fox Corp. (Fed. Cir. 2025), the machine learning technology as recited in claim 4 and described in the Specification is conventional, and the processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output.
Thus, the background of the current application does not provide any indication that the processor is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here).
Also, the claim does not involve a non-conventional and non-generic arrangement of known, conventional pieces, as asserted, by receiving information (e.g. a healthcare plan) from an external source of data. The receiving of data from an external source over a network, such as via the Internet, can fairly be characterized as insignificant extra-solution activity that does not receive patentable weight. See Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008) (en banc), aff’d sub nom Bilski v. Kappos, 561 U.S. 593 (2010) (characterizing data gathering steps as insignificant extra-solution activity). Similar to Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014): “And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis.” Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular asserted inventive technology for performing those functions. They are therefore directed to an abstract idea. As such, the additional elements, considered individually and in combination with the other claim elements, do not make the claim as a whole significantly more than the abstract idea itself.
Accordingly, a conclusion that the recited steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Furthermore, similar to Electric Power Group v Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016) (Power Group), claim’ invocation of computers, networks, and displays does not transform the claimed subject matter into patent-eligible applications. Claim 4 does not require any nonconventional computer, network, or display components, or even a “non-conventional and non-generic arrangement of known, conventional pieces,” but merely call for performance of the claimed information collection, analysis, and display functions on a set of generic computer components and display devices. Nothing in the claim, understood in light of the specification, requires anything other than off-the-shelf, conventional computer, network, and display technology for gathering, sending, and presenting the desired information. Analogous to Power Group, claim 4 does not even require a new source or type of information, or new techniques for analyzing it. As a result, the claim does not require an arguably inventive set of components or methods, such as measurement devices or techniques that would generate new data. The claim does not invoke any assertedly inventive programming. Merely requiring the selection and manipulation of information - to provide a “humanly comprehensible” amount of information useful for users - by itself does not transform the otherwise-abstract processes of information collection and analysis into patent eligible subject matter. Merely obtaining and selecting information, by content or source, for collection, analysis, and display does nothing significant to differentiate a process from ordinary mental processes, whose implicit exclusion from § 101 undergirds the information-based category of abstract ideas. Therefore, the recited steps represent implementing the abstract idea on a generic computer, or “reciting a commonplace business method aimed at processing business information despite being applied on a general purpose computer” Versata, p. 53; Ultramerical, pp. 11-12.
Furthermore, the recited functions do not improve the functioning of computers itself, including of the processor(s) or the network elements. There are no physical improvements in the claim, like a faster processor or more efficient memory, and there is no operational improvement, like mathematical computation that improve the functioning of the computer. Applicant did not invent a new type of computer; Applicant like everyone else programs their computer to perform functions. The Supreme Court in Alice indicated that an abstract claim might be statutory if it improved another technology or the computer processing itself. Using a (programmed) computer to implement a common business practice does neither. The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, storing, comparing and transmitting data—see the Specification as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. “However, it is not apparent how appellant’s programmed digital computer can produce any synergistic result. Instead, the computer will simply do the job it is instructed to do. Where is there any surprising or unexpected result? The unlikelihood of any such result is merely one more reason why patents should not be granted in situations where the only novelty is in the programming of general purpose digital computers”. See Sakraida v. Ag. Pro, Inc., 425 U.S. 273 [ 96 S.Ct. 1532, 47 L.Ed.2d 784], 189 USPQ 449 (1976) and A P Tea Co. V. Supermarket Corp., 340 U.S. 147 [ 71 S.Ct. 127, 95 L.Ed. 162], 87 USPQ 303 (1950).
Further, there are no improvements in said AI/ML techniques, such as advances in the field of computer science itself, or designing a new neural network, and there is no controlling of a technological process using the outcome of said techniques. Said AI/ML algorithms and computations are done inside of a computer, and do not have a real-world impact and are not tied to the functionality of the computer. Further, there is no evidence that the invention lies in the training phase or execution phase or both. However, machine learning subject matter becomes patent-eligible only when it achieves a technical purpose and, at minimum, offers a technical effect that does more than performing the solution more quickly or efficiently. The general application of machine learning techniques to solve a problem predictably is not eligible for patentability.
Furthermore, there is no transformation recited in the claim as understood in view of 35 USC 101. The recited steps merely represent abstract ideas which cannot meet the transformation test because they are not physical objects or substances. Bilski, 545 F.3d at 963. Said steps are nothing more than mere manipulation or reorganization of data, which does not satisfy the transformation prong. It is further noted that the underlying idea of the recited steps could be performed via pen and paper or in a person's mind. Moreover, “We agree with the district court that the claimed process manipulates data to organize it in a logical way such that additional fraud tests may be performed. The mere manipulation or reorganization of data, however, does not satisfy the transformation prong.” and “Abele made clear that the basic character of a process claim drawn to an abstract idea is not changed by claiming only its performance by computers, or by claiming the process embodied in program instructions on a computer readable medium. Thus, merely claiming a software implementation of a purely mental process that could otherwise be performed without the use of a computer does not satisfy the machine prong of the machine-or-transformation test”. CyberSource, 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, because, when considered separately and in combination, the claim elements do not add significantly more to the exception. Considered separately and as an ordered combination, the claim elements do not provide an improvement to another technology or technical field; do not provide an improvement to the functioning of the computer itself; do not apply the judicial exception by use of a particular machine; do not effect a transformation or reduce a particular article to a different state or thing; and do not add a specific limitation other than what is well-understood, routine and conventional in the operation of a generic computer. None of the hardware recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). As per “A computer-implemented method”, “input … data to a machine learning model”, “storing a digital asset” recitations, these limitations do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment, that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). Limiting the claims to the particular technological environment is, without more, insufficient to transform the claim into patent-eligible applications of the abstract idea at their core.
Accordingly, claim 4 is not directed to significantly more than the exception itself, and is not eligible subject matter under § 101. (Step 2B: No).
Further, although the Examiner takes the steps recited in the independent claim as exemplary, the Examiner points out that limitations recited in dependent claim 8 further narrow the abstract idea but do not make the claims any less abstract. Dependent claim 8 merely adds further details of the abstract steps recited in claim 4 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. These claims "add nothing of practical significance to the underlying idea," and thus do not transform the claimed abstract idea into patentable subject matter. Ultramercial, 772 F.3d at 716. Therefore, dependent claim 8 is also directed to non-statutory subject matter.
Because Applicant’s apparatus claims 14 and 18 add nothing of substance to the underlying abstract idea, they too are patent ineligi-ble under §101.
Preliminary Note
During patent examination, the pending claims must be interpreted as broadly as their terms reasonably allow. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 320,322 (Fed. Cir. 1999). In determining the patentability of claims, the PTO gives claim language its broadest reasonable interpretation" consistent with the specification and claims. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). See MPEP § 904.1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4, 8, 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Vishnubhatla et al. (US 2010/0324936 A1) (IDS of 01/30/2026) in view of Zimmerman et al. (US 2019/0005200 A1).
Claims 4 and 14. Vishnubhatla et al. (Vishnubhatla) discloses a computer-implemented method for analyzing healthcare data, comprising:
obtaining healthcare and economic data about a subject comprising one or more of: an output of a diagnostic or therapeutic device used to diagnose or treat the subject, a result or outcome of a medical procedure completed on or by the subject, a prescription, a medication, a medical item, an insurance, and a payment; [0015] – [0017]; [0056]; [0080]; [0081]; [0120]; [0293]
using the healthcare data to:
(1) calculate a statistical probability that an immediate or future adverse change in a health or an economic condition of the subject or a population that includes the subject will require a current or a future medical treatment involving at least a portion of the medication, the medical item, or a healthcare order or plan immediately or during a future time period; [0122] – [0125]; [0126] – [0129]; [0294], and
(2) input the healthcare data to a machine learning model that classifies a current or a future health or economic risk for the subject that requires a current or a future medical treatment involving the at least a portion of the medication, the medical item, or the healthcare order or plan, wherein the healthcare order or plan is received from a healthcare provider or from an output of an artificial intelligence model; [0122] – [0129]; [0153] – [0156]; [0330]
storing a digital asset or a digital twin, [0110] – [0116], wherein:
the digital asset comprises the subject's healthcare data, the calculated future adverse change in health or economic condition or the machine learning classification of the current or future health or economic risk, information about the future medical treatment, and information about the medication, the medical item, or the healthcare order or plan; [0126] – [0129]; [0140]; [0153] – [0156]; [0212]; [0234]
the digital asset comprises records of the medical procedure completed on or by the subject or the diagnostic or therapeutic device used to diagnose or treat the subject;
the storing comprises using one or more of a distributed ledger, a blockchain, or a database; and the digital asset or the digital twin is owned by the subject or is assigned to another party. [0099]; [0187]; [0201]; [0203]; [0221]; [0340]; [0341]; [0393]
Alternatively, language as to “the digital asset or the digital twin is owned by the subject or is assigned to another party” does not require a method step to be performed, and cannot affect the recited method steps. Therefore, said language is given no patentable weight. MPEP 2111.04 states: “Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation.”
While Vishnubhatla discloses that said electronic records are configured to automatically display patient pictures, medication pictures and additional information that may aid verification and prescription safety [0234], Vishnubhatla does not specifically teach a digital twin comprising a virtual representation of the medical procedure completed on or by the subject or the diagnostic or therapeutic device used to diagnose or treat the subject, which is disclosed in Zimmerman et al. (Zimmerman) Abstract; [0031] – [0033]; [0035] - [0042]; [0044] – [0045]; [0064]; [0080]. The Examiner notes that the effective date of the recited “digital twin” limitations is the filing date of the current application, 11/17/2022.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vishnubhatla to include the recited limitations, as disclosed in Zimmerman, because it would advantageously allow to use the patient digital twin to help drive a continuous loop of patient care, as specifically stated in Zimmerman. [0055]
Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vishnubhatla to include the recited limitations, as disclosed in Zimmerman, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Claims 8 and 18. The method according to claim 4, further comprising using an artificial intelligence or machine learning technique to perform a diagnostic or a therapeutic analysis of the subject and directing the subject to implement a current or a new health-related action, ordered by a licensed healthcare provider, in a supervised or unsupervised setting, synchronously in real time or asynchronously supervised during a proximate or future time. Vishnubhatla, [0055]; [0056]; [0119]; [0120]; [0126] – [0129]; [0138]; [0140]; [0153] – [0156]; [0212]; [0234]; Zimmerman, [0033]; [0036]; [0043]; [0053]; [0054]; [0062]; [0064]; [0068]; [0070]; [0079]; [0083]; [0160]. Same rationale as applied to claims 4 and 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Igor Borissov whose telephone number is 571-272-6801. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Kambiz Abdi can be reached on 571-272-6702. 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 http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/IGOR N BORISSOV/Primary Examiner, Art Unit 3685 2/19/2026
Prosecution Insights