Detailed Notice
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-21 and 23-28 are currently pending.
Claims 22 was canceled.
Claims 1-21 and 23-28 are amended.
Claims 1-21 and 23-28 are rejected.
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 25-27 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. The specification does not disclose "a particular course of treatment comprising a glycogen storage disease medication is used for the individual to treat a glycogen storage disease condition of the individual", " the particular course of treatment includes a late-onset disease medication, and wherein using the glycogen storage disease medication for the individual treats a late-onset Pompe disease condition of the individual", and "wherein the intervention action comprises: modifying a glycogen storage disease treatment scheduled for the individual and applied to the individual to treat a late-onset Pompe disease condition of the individual, and order and scheduling diagnostics". The closest paragraph in the specification to disclose this limitations are [0043]: "indexing or mapping variables in records, or mapping disparate health systems' ontologies, such as determining that a particular medication frequency of a first record system is the same as another record system", and [0075]: "For the computation of probability or severity of a lysosomal storage disorder: the demographics, laboratory tests, diagnoses, medications, and physical exam records of 3,605 patients having received enzyme-proven diagnosis of late-onset Pompe disease... The retrieval encompassed more than 500 laboratory tests, 23 vital signs and flowsheet observation types, and more than 900 medication types as input variables for classification and predictive analysis", which does not disclose "a particular treatment comprising a glycogen storage disease medication is used for the individual to treat a glycogen storage disease condition of the individual", "wherein the particular course of treatment includes a late-onset disease medication, and wherein using the glycogen storage disease medication for the individual treats a late-onset Pompe disease condition of the individual", and "wherein the intervention action comprises: modifying a glycogen storage disease treatment scheduled for and applied to the individual to treat a late-onset Pompe disease condition of the individual, and order and scheduling diagnostics".
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-21 and 23-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
In the instant case, claims 1-6, 21, and 23-28 are directed toward a method (i.e. a process) and claims 7-12 are directed toward a non-transitory media (i.e., manufacture), and claims 13-20 are directed toward a system (i.e. machine). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A—Prong 1:
Independent claims 1, 7, and 13 recites steps that, under their broadest reasonable interpretations, cover performance of the limitations of a certain method of organizing human activity but for the recitation of generic computer components.
Claim 1 recites: “A method, comprising: determining via one or more hardware processors (OOMHPs) a multi-variable (MV) biomarker based on a set of physiological variables associated with an individual, wherein the set of physiological variables is received via the OOMHPs as input data at a medical records computer system associated with an electronic memory; determining, at the OOMHPs, a probability of a clinically significant glycogen storage (CSGS) disease for the individual based on the MV biomarker and based further on a machine-learning electronic model, wherein:(a) the machine-learning electronic model is trained based on (i) data associated with MV biomarker instances comprising a plurality of: myalgia, comorbidity, creatine kinase, red blood cell size distribution width, aminotransferases, alanine aminotransferase to aspartate aminotransferase ratio, erythrocyte microcytosis, anion gap, or hypothyroidism and (ii) one or more decision elements associated with the MV biomarker instances, and(b) applying the machine-learning electronic model to data associated with the MV biomarker generates information indicating the probability of the CSGS disease; electronically writing, via the OOMHPs, electronic encoded data to the electronic memory at the medical records computer system, wherein the electronic encoded data indicates the probability of the CSGS disease; and automatically initiating via the OOMHPs an intervention action, wherein automatically initiating via the OOMHPs the intervention action comprises transmitting to an electronic device associated with the medical records computer system information identifying the probability of the CSGS disease”.
The limitations of determining… a multi-variable (MV) biomarker based on a set of physiological variables associated with an individual, wherein the set of physiological variables is received… as input data; determining, a probability of a clinically significant glycogen storage (CSGS) disease for the individual based on the MV biomarker…, wherein:(a) the machine-learning electronic model is trained based on (i) data associated with MV biomarker instances comprising a plurality of: myalgia, comorbidity, creatine kinase, red blood cell size distribution width, aminotransferases, alanine aminotransferase to aspartate aminotransferase ratio, erythrocyte microcytosis, anion gap, or hypothyroidism… and (b)… generates information indicating the probability of the CSGS disease; electronically writing, electronic encoded data…, wherein the electronic encoded data indicates the probability of the CSGS disease; and automatically initiating… an intervention action, wherein automatically initiating…, the intervention action comprises transmitting… information identifying the probability of the CSGS disease, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of determining, receive, train, generates, writing, indicates, initiating, and transmitting, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Further, the abstract idea of claims 7 and 13 are identical as the abstract idea of claim 1. This limitation, given the broadest reasonable interpretation, also falls under the abstract idea of a certain method of organizing human activity because it recites managing personal behavior or relationships or interactions between people.
Dependent claims 2-6, 8-12, 14-21, and 23-28 include other limitations, as well as specific step of data to be processed, received, and applied, but these only serve to further limit the abstract idea and do not add and additional elements, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 7, and 13. However, recitation of an abstract idea is not the end of the 35 U.S.C. 101 analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A—Prong 2:
Claims 1-21 and 23-28 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
Amount to mere instructions to apply an exception—for example, the recitation of “processor”, “machine-learning model”, “medical records computer system”, “decision elements”, “one or more hardware processors (OOMHPs)”, “electronic memory”, and “non-transitory media”, which amount to merely invoking a computer as a tool to perform the abstract idea, e.g. see FIG. 1A, FIG. 1B, and [0013]-[0017], of the present specification, and see further MPEP 2106.05(f);
Generally linking the abstract idea to a particular technological environment or field of use, for example, “via one or more hardware processors (OOMHPs)”, “via the OOMHPs”, “at a medical records computer system associated with an electronic memory”, “at the OOMHPs”, “on a machine-learning electronic model”, “(ii) one or more decision elements associated with the MV biomarker instances”, “(b) applying the machine-learning electronic model to data associated with the MV biomarker”, and “to the electronic memory at the medical records computer system”, which amounts to limiting the abstract idea to the field of technology/the environment of computers, see MPEP 2106.05(h); and/or
Merely acquiring information for further analysis by the system and the particular manner of acquisition is not described or shown to be important, for example, “received via the OOMHPs as input data at a medical records computer system associated with an electronic memory”, which amounts to insignificant extra-solution activity in the form of mere data gathering because it merely functions tangentially to the main idea of the invention and serves only to bring in the data necessary for the inventions main analysis, see MPEP 2106.05(g).
Additionally, dependent claims 2-6, 8-12, 14-21, and 23-28 include other limitations, but as stated above, the limitations recited by these claims do not include any additional elements beyond those already recited in independent claims 1, 7, and 13, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B:
The claims do not include additional elements (i.e., “processor”, “machine-learning model”, “medical records computer system”, “decision elements”, “one or more hardware processors (OOMHPs)”, “electronic memory”, and “non-transitory media”) that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the elements other than the abstract idea), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, which even when reevaluated under the considerations of Step 2B of the analysis, do not amount to “significantly more” than the abstract idea.
Dependent claims 2-6, 8-12, 14-21, and 23-28 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 7, and 13, and hence do not amount to “significantly more” than the abstract idea.
Additionally, the additional elements (i.e., “received via the OOMHPs as input data at a medical records computer system associated with an electronic memory”), add extra solution activity, which comprises limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in a particular field as demonstrated by:
Relevant court decisions (See MPEP 2106.05(d)(II)):
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)).
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-21 and 23-28 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 01/15/2026 have been fully considered but they are not persuasive. Regarding the 35 U.S.C. 101 Rejection, Applicant argues the claims do not recite an abstract idea of a certain method of organizing human activity because the claims do not recite human action/activity. Examiner respectfully disagrees. The claims do not have to recite a human action directly, but an action that human is capable of performing via pen and paper, other persons, or with a computer tool(s) (See MPEP 2106.04(a)(2)II: “Finally, the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings”). A person is capable via pen and paper, other persons, or with a computer tool(s) of determining a multi-variable biomarker, determining a probability of a clinically significant glycogen storage disease, writing encoded data which indicates the probability of the clinically significant glycogen storage disease, and initiating an intervening action (see MPEP 2106.04(a)(2) C. Managing Personal Behavior or Relationships or Interactions Between People: “Other examples of managing personal behavior recited in a claim include: iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)”).
Applicant further argues the claims recite an improvement to a technical field like in CardioNet v. InfoBionic (hereinafter CardioNet). Applicant also argues the claims are eligible under MPEP 2106.05(a) and MPEP 2106.06(b). Applicant also argues the claims improve the technological field of computerized reduction of patient risks to disorders, computer reduction of under diagnoses of medical records, machine learning electronic models for predicting clinical condition risk levels, reducing computing and communication inefficiencies, and reducing processing errors. Examiner respectfully disagrees. CardioNet was eligible because the invention improved how cardia data is processed by using beat-to-beat variability analysis overtime to detect atrial fibrillation. Thus, it addresses the technical problem in cardiac telemetry by more accurately detecting arrythmias. The current application is not eligible because the type of data analysis is very high level and common for machine learning model, therefore using a conventional medical practice on generic computer tools. The amended claims do not improve the technology as needed in MPEP 2106.05(a) because, although the methodology of data collection, analysis, or type of data may be improved, this is not an improvement to the technology and the functionality of the technology itself. Additionally, the Applicant has not identified any claims or limitations that “reduc[e] computing and communication inefficiencies, and reduc[e] processing errors”. It is unclear how the limitations reduce computing or communication inefficiencies or reduce processing errors. Furthermore, the technical problems the Applicant presents are to the abstract idea. The abstract idea cannot integrate itself into a practical application. Lastly, under MPEP 2106.06(b) the claims must be unconventional and have a specific implementation that is not routine, or the technical arrangement adds something meaningful. However, the claims do not reflect something unconventional in predicting glycogen storage disease and, as shown above, merely use computer tools (the additional elements) to perform (link/apply) the abstract idea.
Applicant further argues the claims are directed to a data-structure building (DSB) machine, generating a model, and using output of the model, which integrates any alleged abstract idea into a practical application. Examiner respectfully disagrees. The DSB machine and model are all recited at a high level of generality that amount to generic computer tools that are being applied/linked with the abstract idea. Therefore, the additional elements do not integrate the abstract idea into a practical application
Applicant further argues the additional elements amount to significantly more. Examiner respectfully disagrees. The additional elements (“processor”, “machine-learning model”, “medical records computer system”, “decision elements”, “one or more hardware processors (OOMHPs)”, “electronic memory”, and “non-transitory media”), are recited at a high level of generality and merely link/apply the abstract idea to the additional elements, which does not amount to significantly more. Therefore, the 35 U.S.C. 101 Rejection is maintained.
Regarding the 35 U.S.C. 112(a) Rejection, Applicant argues the amendments to claims 25-27 overcome the rejection. Examiner respectfully disagrees. Claims 25-27 still recite a particular treatment comprising glycogen storage disease medication is used for the individual to treat a glycogen storage disease condition, the particular course treatment includes a late-onset Pompe disease medication, and modifying a glycogen storage disease treatment scheduled for the individual, which is not disclosed in the specification and is new matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL SOJIN STONE whose telephone number is (571)272-8798. The examiner can normally be reached Monday-Friday 7 AM - 7 PM (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.S.S./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
Prosecution Insights