DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to an application filed 18 September 2023, which is a national stage entry of an application with an international filing date of 21 March 2022, which claims domestic priority to a provisional application filed 19 March 2021.
Claims 1-20 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 September 2023 and 19 February 2025 have been considered by the Office to the extent indicated.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings contain lines of insufficient weight, text of insufficient size and/or shading that make the drawings illegible, see Figs. 1-6 and 8-11. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 5 recites the limitation representative of the a a feature’s association with hypoglycemia. It is unclear how to interpret this limitation.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-20 are within the four statutory categories. Claims 1-16 are drawn to a system for predicting hypoglycemia risk, which is within the four statutory categories (i.e. machine). Claims 17-18 are drawn to a method for predicting hypoglycemia risk, which is within the four statutory categories (i.e. process). Claims 19-20 are drawn to a computer readable medium having instructions stored thereon that when executed by a processor causes the processor to predict hypoglycemia risk, which is within the four statutory categories (i.e. manufacture).
Prong 1 of Step 2A
Claim 1 recites: A system for predicting hypoglycemia risk, the system comprising:
a processor including instructions to cause the processor to:
receive a first set of patient data;
apply data processing to identify features of the first set of patient data that are associated with hypoglycemia;
apply multivariable modeling to the features to generate a multivariable model that outputs a risk score associated with future hypoglycemia where the multivariable model captures a pathophysiological signature of impending hypoglycemia;
receive a second set of patient data, apply data processing to identify features of the second set of patient data, and apply the multivariable model to generate a risk score for the second set of patient data;
analyze the risk score of the second set of patient data to determine an appropriate clinical decision support; and
output a result for access by a device;
wherein at least one or more of the first set of patient data and/or the second set of patient data are representative of a physiological measurement from at least one or more of a cardiorespiratory monitoring (CRM) data source, an electronic medical record (EMR) vital sign data source, and/or a biochemical laboratory (LAB) data source.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract ideas of a mental process and/or a certain method of organizing human activity because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions – in this case, the steps of processing data using models to generate a risk score and appropriate clinical decision support) or using a pen and paper, but for the recitation of generic computer components (i.e. the structural components of the computer), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for claims 17 and 19 are identical as the abstract idea for claims 1, because the only difference between claims 1, 17 and 19 is that claim 1 recites a system method, whereas claim 17 recites a method and claim 19 recites a computer-readable medium.
Dependent claims 2-16, 18 and 20 include other limitations, for example claims 2-5, 12-16, 18 and 20 further describe previously recited data or modeling and claims 6-11 recite signal or notification generation, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 2-16, 18 and 20 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2-16, 18 and 20 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 17 and 19.
Prong 2 of Step 2A
Claims 1, 17 and 19 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the structural components of the computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraph 139 of the present Specification, see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language limiting the data to healthcare related data, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 2-16, 18 and 20 include other limitations, but these limitations also amount to no more than mere instructions to apply the exception (e.g. the various devices, systems and data store disclosed in claims 6, 9 and 12) and/or do not include any additional elements beyond those already recited in independent claims 1, 17 and 19, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1, 17 and 19 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the dispensing device and the one or more processors), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Paragraph 139 of the Specification discloses that the additional elements (i.e. the structural components of the computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log); and
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Dependent claims 2-16, 18 and 20 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, 8, and 15, and/or the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. the various devices, systems and data store disclosed in claims 6, 9 and 12), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
As per claims 19-20, the broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent (see [0147] as filed; CRM description is open ended, i.e., “can”). A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation “non-transitory” to the claim. See 1351 OG 212 (February 23, 2010).
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 and 12-20 are rejected under 35 U.S.C. 103 as being obvious over Wexler et al. (U.S. PG-Pub 2020/0375549 A1), hereinafter Wexler, further in view of Fossat et al. (U.S. PG-Pub 2024/0013915 A1), hereinafter Fossat.
As per claims 1, 5, 17 and 19, Wexler discloses the method of claim 1, detailed above. Wexler also discloses a computer readable medium having instructions stored thereon that when executed by a processor causes the processor to predict hypoglycemia risk, and a method and a system for predicting hypoglycemia risk, the system (Wexler, see Figs. 1, 4 and 7.) comprising:
a processor including instructions to cause the processor (Wexler, see Figs. 1, 4 and 7.) to:
receive a first set of patient data (Wexler discloses reception of data of first, second and third data of patients, see Fig, 4 #s 402a, 402b and 402c and paragraphs 88-89.);
apply data processing to identify features of the first set of patient data that are associated with hypoglycemia (Using initial patient and population models, Wexler identifies features #426 associated with hypoglycemia, see paragraphs 67-70, 72 and 81-84.);
apply multivariable modeling to the features to generate a multivariable model that outputs a risk score associated with future hypoglycemia where the multivariable model captures a pathophysiological signature of impending hypoglycemia (Identified features are used to generate a model enabled to output risk future hypoglycemia, the aggregate model #430, see Wexler, paragraphs 81-86.);
receive a second set of patient data, apply data processing …, and apply the multivariable model to generate a risk score for the second set of patient data (Wexler receives an additional data set, herein dataset #402d so as to process the dataset using the identified features to generate a corresponding risk score #434, see paragraphs 90-91. The Office notes that a predicted likelihood of a hypoglycemia event would comprise a risk score.);
analyze the risk score of the second set of patient data to determine an appropriate clinical decision support (System provides a notification to the patient device pursuant to the predicted risk score, see paragraphs 47, 74, 112, 133 and 123.); and
output a result for access by a device (System provides a notification to the patient device pursuant to the predicted risk score, see paragraphs 47, 74, 112, 133 and 123.);
wherein at least one or more of the first set of patient data and/or the second set of patient data are representative of a physiological measurement from at least one or more of a cardiorespiratory monitoring (CRM) data source, an electronic medical record (EMR) vital sign data source, and/or a biochemical laboratory (LAB) data source (Wexler, receives data from a variety of sources, see paragraphs 20-23, 30, 32 and 36-47.).
5. the processor is configure to analyze at least one or more of the features of the first set of patient data and/or the features of the second set of patient data to identify data representative of the a a feature's association with hypoglycemia (Using initial patient and population models, Wexler identifies features #426 associated with hypoglycemia, see paragraphs 67-70, 72 and 81-84.).
Wexler fails to explicitly disclose:
1,17,19. to identify features of the second set of patient data; and
5. feature importance measures.
Fossat teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
1,17,19. to identify features of the second set of patient data (Fossat discloses identifying features from a plurality of datasets, see paragraphs 10-14.); and
5. feature importance measures (Fossat discloses the determination of feature importance measures, see paragraphs 14 and 33 and Fig. 34.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the biomonitoring and blood glucose forecasting method of Wexler to include identifying features of the second set of patient data and determining feature importance measures, as taught by Fossat, in order to provide a biomonitoring and blood glucose forecasting method that can use additional methods to identify a user’s risk of hypoglycemia (Fossat, Abstract).
Both Wexler and Fossat are directed to the electronic processing of patient healthcare data and specifically to the display of monitored patient data. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
As per claims 2-7 and 12-16, Wexler/Fossat discloses claims 1, 17 and 19, discussed above. Wexler also discloses:
2. at least one or more of the first set of patient data and/or the second set of patient data includes a biochemical measurement (Wexler, paragraph 34.);
3. the physiological measurement includes waveform data related to heart rate and/or respiratory rate (Wexler includes heart rate data, see paragraphs 20 and 37. The Office notes that it is old and well known to use waveform data related to heart or respiratory data.);
4,17,20.the multivariable modeling includes at least one or more of: logistic regression, random forest, xgboost, support vector machines, nearest neighbor, artificial neural networks, and/or long short-term memory (LSTM) (Wexler, paragraph 49.);
6. the processor in combination with at least one or more of a glycemic state monitoring device, a glucose management system, and/or an insulin recommendation system, wherein: the processor is configured to generate a signal to inform the glycemic state monitoring device, the glucose management system, and/or the insulin recommendation system about hypoglycemia risk based on the analysis of the risk score (Predicted risk is provided to user device running an app that can be interpreted as a glycemic state monitoring device, the glucose management system, and/or the insulin recommendation system, see paragraphs 47, 74, 112, 133 and 123 and Figs. 6A-6I.);
7. the processor is configured to generate the signal that includes a notification communication recommending, based on the analysis of the risk score, at least one or more of: risk of hypoglycemia, change in risk of hypoglycemia, check patient glucose level, modification of insulin dosage, modification of basal insulin, modification of basal insulin rate, modification of insulin infusion rate, and/or modification of patient nutritional administration (System provides a notification to the patient pursuant to the predicted risk score, see paragraphs 47, 74, 112, 133 and 123.);
12. the processor in combination with a data store, wherein: the data store is configured to contain plural multivariable models (Database 106 is used to store the various types of data used by the system, which would include the models, see paragraph 43.);
13. the processor is configured to select the multivariable model for implementation from the plural multivariable models based on at least one or more of: a type of first set patient data and/or a type of second set patient data (Model is selected based on features extracted from data, see paragraph 82.);
14. the processor is configured to switch from a first multivariable model to a second multivariable model for implementation based on at least one or more of: a type of first set patient data and/or a type of second set patient data (Model is selected based on features extracted from data, see paragraph 82.);
15. the plural multivariable models include at least one or more of: a CRM data model; an EMR vital sign data model; a LAB data model; a CRM / EMR vital sign data model; a CRM / LAB data model; an EMR vital sign / LAB data model; and/or a CRM / EMR vial sign / LAB data model (Models are generated using data from a variety of sources, including an EMR vital data, see paragraphs 20-23, 30, 32 and 36-47.);
16. the processor is configured to update the multivariable model based at least one or more of: a type of first set patient data and/or a type of second set patient data (Models are updated based on new/additional information or other parameters that could be considered a data type, see paragraphs 47 and 87.).
Claims 8-11 are rejected under 35 U.S.C. 103 as being obvious over Wexler/Fossat further in view of Patek et al. (U.S. PG-Pub 2020/0046268 A1), hereinafter Patek.
As per claims 8-11, Wexler/Fossat discloses claims 1 and 7, discussed above. Wexler also discloses:
8. the processor is configured to generate the notification communication recommending … a glucose clamp, wherein blood glucose is maintained within a range so as to bound blood glucose to an upper level and/or a lower level (System provides recommendation to patient device to display information in order to keep glucose within an acceptable range, see paragraphs 18, 47, 61, 74, 112, 116, 133 and 123.);
9. wherein the processor is configured to generate a signal to inform the … device about hypoglycemia risk based on the analysis of the risk score (System provides a notification to the patient device pursuant to the predicted risk score, see paragraphs 47, 74, 112, 133 and 123.);
10. the processor is configured to generate the signal that includes a command signal requiring, based on the analysis of risk, at least one or more of: risk of hypoglycemia, change in risk of hypoglycemia, check patient glucose level, modification of insulin dosage, modification of basal insulin, modification of basal insulin rate, modification of insulin infusion rate, and/or modification of patient nutritional administration (System provides a notification to the patient pursuant to the predicted risk score, see paragraphs 47, 74, 112, 133 and 123, which is displayed on the user device, e.g. the device is required to display the risk.); and
11. providing instructions pursuant to a glucose clamp, wherein blood glucose is maintained within a range so as to bound blood glucose to an upper level and/or a lower level (System provides recommendation to patient device to display information in order to keep glucose within an acceptable range, see paragraphs 18, 47, 61, 74, 112, 116, 133 and 123.).
Wexler/Fossat fails to explicitly disclose an insulin delivery device and generating a signal instructing a change of an insulin infusion rate.
Patek teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide an insulin delivery device and generating a signal instructing a change of an insulin infusion rate, in order to control a user’s risk of hypoglycemia (Patek, Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the biomonitoring and blood glucose forecasting method of Wexler/Fossat to include an insulin delivery device and generating a signal instructing a change of an insulin infusion rate, as taught by Patek, in order to provide a biomonitoring and blood glucose forecasting method that can control a user’s risk of hypoglycemia (Patek, Abstract).
Both Wexler and Patek are directed to the electronic processing of patient healthcare data and specifically to the display of monitored patient data. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Conclusion
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
31 October 2025