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 .
DETAILED ACTION
The present office action represents the first action on the merits.
Claims 1-20 are pending.
Priority
This application claims priority to WIPO Application PCT/US2023/024301 dated 02 June 2026 which claims priority to U.S. Provisional Patent Application No. 63/348,315 dated 02 June 2022.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/348,315, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, there does not appear to be written description support got the following limitation (Claim 1 being representative): classify the newly received glucose measurement trace by either evaluating the trace by a predefined feature-based classifier or by searching by comparing a newly received glucose measurement trace to the at least one classification using a similarity metric and classifying the newly received glucose measurement trace with the representation based on a matched similarity metric in response to the comparing.
The ’315 application does not appear to describe matching glucose measurement traces from a patient to those in a database by (1) a predefined feature-based classifier or (2) classifying a new trace using a similarity metric. There is no discussion of comparing a trace to stored traces to see if they match. Nor is there discussion of a feature-based classifier or similarity metric. The Examiner notes that the Applicant incorporates by reference no less than 12 pages of documents at the end of the ‘315 Specification. Should support for the noted features be present in any one of these documents, the Examiner requests that the Applicant point to the specific location/document where support is provided. The earliest priority date where support for these features appears to be present is the filing date for PCT/US2023/024301 dated 02 June 2023.
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 02 December 2024 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Claim Objections
Claim 4 is objected to because it requires an “and” after “individuals diagnosed with the specified physiological disorder;…” in order to distinguish the limitations. Appropriate correction/clarification 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.
Claims 1 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a system and method for efficient physiological diagnosis of a specified physiological disorder, which are within a statutory.
Step 2A1
The limitations of (Claim 1 being representative) store glucose measurement data and a representation for at least one classification of the glucose measurement data, wherein: the glucose measurement data is associated with at least one controlled glycemic-response consumption activity; and the representation is an indication that a glucose measurement trace from the glucose measurement data is associated with a specified physiological disorder or is indicative of the specified physiological disorder; receive a new glucose measurement possibly associated with controlled glycemic-response consumption activity; classify the newly received glucose measurement trace by either evaluating the trace by a predefined feature-based classifier or by searching by comparing a newly received glucose measurement trace to the at least one classification using a similarity metric and classifying the newly received glucose measurement trace with the representation based on a matched similarity metric in response to the comparing; and ascribe a clinical recommendation or assessment based on the representation of the classified newly received glucose measurement trace, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to perform efficient physiological diagnosis of a specified physiological disorder (see Spec. Para. 0004 describing the claimed functionality as a human activity) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “store… receive… classify… and ascribe” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a system implemented by a processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the Claim 1 recites the additional elements of a processor, memory, and data store (i.e., a computer) that implements the identified abstract idea. Claim 17 does not recite any additional elements and is purely directed to an abstract idea. The computer is not described by the applicant and is recited at a high-level of generality (i.e., a generic computer performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
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 computer to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Claims 2-16 and 18-20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 18 merely describe(s) the recommendation/assessment, which further defines the abstract idea.
Claim(s) 3, 19 merely describe(s) the glycemic-response consumption activity, which further defines the abstract idea.
Claim(s) 4, 20 merely describe(s) the data in the data store, which further defines the abstract idea.
Claim(s) 5 merely describe(s) the type of disorder and an antibody, which further defines the abstract idea.
Claim(s) 6 merely describe(s) the representation and the similarity metric, which further defines the abstract idea.
Claim(s) 7 merely describe(s) the source of the glucose measurement(s), which further defines the abstract idea.
Claim(s) 7 also includes the additional elements of “a glucose measurement device” which each generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim(s) 8 merely describe(s) the measured data, which further defines the abstract idea.
Claim(s) 9 merely describe(s) the glucose trace, which further defines the abstract idea.
Claim(s) 10 merely describe(s) either storing, transmitting or monitoring data, which further defines the abstract idea.
Claim(s) 10 also includes the additional elements of “one or more of a predictive modeling system, a decision support system, an insulin delivery system, an insulin monitoring system, or an automated control system” which each generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim(s) 11, 12, 13 merely describe(s) how the classification occurs, which further defines the abstract idea.
Claim(s) 11 also states that the classification may occur via an “LR” techniques, which is included as part of the abstract idea because it represents a function that humans perform. Alternately or in addition, LR represents a mathematical concept, which is a form od abstract idea. The different types of abstraction are considered together for subject matter eligibility analysis purposes.
Claim(s) 14 merely describe(s) the stored data, which further defines the abstract idea.
Claim(s) 15 merely describe(s) receiving data, which further defines the abstract idea.
Claim(s) 16 merely describe(s) generating and communicating data, which further defines the abstract idea.
Claim(s) 16 also includes the additional elements of “a c-peptide measurement device” which generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim Rejections - 35 USC § 112
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 3, 5, 11-13 and 19 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 pre-AIA the applicant regards as the invention.
Claims 3 and 19 recites “wherein: the controlled glycemic-response consumption activity includes consumption of an energy drink in lieu of a meal.” The claim is indefinite because it is unclear what “meal” the claim is referring to. No meal was recited to previously exist. Further, an energy drink may be considered a meal given the broadest reasonable interpretation of the phrase. Thus, it is unclear how the claim can substitute a meal in lieu of a meal. Finally, it is unclear whether the claim requires substitute of the (presumably defined) meal for another meal that “includes” an energy drink. The Examiner suggests reciting: wherein the controlled glycemic-response consumption activity is consumption of an energy drink. The claim has been interpreted as such.
Claim 5 recites “the autoantibody.” There is insufficient antecedent basis for this limitation in the claim. Perhaps Claims 5 and 6 were meant to be claimed in the reverse order?
Claim 11 recites “wherein: the classification of the glucose measurement data contained in the physical data store is based on one or more classifier models….” The claim is indefinite because it is unclear what the claim is further limiting; this feature lacks antecedent basis. No classification of glucose measurement data contained in the physical data store ever occurred in Claim 1. The “classify” step of Claim 1 is not in reference to data in the data store. For the purposes of examination, the Examiner assumes the “one or more classifier models” is in reference to the “feature-based classifier” of Claim 1.
By virtue of their dependence from Claim 11, this basis of rejection also applies to dependent Claims 12 and 13.
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.
Claim(s) 1, 2, 4-14, 17, 18, and 20 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Bikhchandani et al. (hereinafter “Bik;” U.S. Patent No. 11,166,670).
REGARDING CLAIM 1
Bik teaches the claimed database management system for efficient physiological diagnosis of a specified physiological disorder, the system comprising:
a physical data store containing […data…]; and [Col. 17, Lns. 42-44, Col. 26, Lns. 23-25 teaches a database (a physical data store) storing data. Alternately or in addition, Col. 31, Lns. 20-58 teaches memory (a physical data store) storing data.]
a processor and computer memory configured with instructions stored thereon that when executed will cause the processor to: [Fig. 16, Col. 6, Lns. 5-16, Col. 7, Lns. 30-43 teaches a personal computer having a processor and memory that implements a diabetes management platform.]
receive a new glucose measurement possibly associated with controlled glycemic-response consumption activity; and [Col. 6, Lns. 42-53 Col. 8, Lns. 40-42 teaches that physiological data from a user is collected from a CGM which transmits the data continually to the platform. The data may indicate a meal has been consumed (a “controlled glycemic-response consumption activity”). The received data is “traced” data, see Fig. 4, 8, 9.]
classify the newly received glucose measurement trace by either [Col. 6, Lns. 42-50 teaches that the physiological data is correlated to a blood glucose level excursion associated with a meal. Col. 9, Lns. 26-28 teaches that the excursion(s) is/are detected. The Examiner interprets a “trace” to be a collection of received data points.]
evaluating the trace by a predefined feature-based classifier or [Col. 9, Lns. 60-63 teaches that the excursion is detected by determining whether the data (i.e., traced data) matches a pattern defined in a classification model (a predefined feature-based classifier). See also, Col. 12, Lns. 37-51.]
by searching the physical data store by comparing a newly received glucose measurement trace to the at least one classification using a similarity metric and classifying the newly received glucose measurement trace with the representation based on a matched similarity metric in response to the comparing; and
ascribe a clinical recommendation or assessment based on the representation of the classified newly received glucose measurement trace. [Col. 6, Lns. 50-58, Col 12, Ln. 52—Col. 13, Ln 7 teaches that a recommendation determined and provided (ascribed) based on the result of analyzing the new physiological data indicating a meal.]
Bik may not teach that the physical data store contains
glucose measurement data and a representation for at least one classification of the glucose measurement data, wherein:
the glucose measurement data is associated with at least one controlled glycemic-response consumption activity; and
the representation is an indication that a glucose measurement trace from the glucose measurement data is associated with a specified physiological disorder or is indicative of the specified physiological disorder
However, the limitation claims information/labels that constitute nonfunctional descriptive information that is/are not functionally involved in the recited system. The function described by the system would be performed the same regardless of whether the claimed information/labels was substituted with nothing. Because the Bik teaches a database storing data having data labels, substituting the information/labels of the claimed invention for the information/labels of the prior art would be an obvious substitution of one known element for another, producing predictable results. Therefore, would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have substituted the information/labels applied to the stored data of the prior art with any other information/labels because the results would have been predictable. MPEP 2112.01, Section III (see also In re Ngai, Ex Parte Breslow). The Examiner notes that the optional feature that utilized particularly-recited types of data (“classify the newly received glucose measurement trace by either…or by searching the physical data store…”) was not selected, the data in the physical data store is not required by the claim and the data that is stored is thus non-functional with respect to the claim.
REGARDING CLAIM 2
Bik teaches the claimed database management system of Claim 1. Bik further teaches
the clinical recommendation or assessment includes a treatment related to initiating, modifying, or forgoing administration of synthetic insulin based on the representation. [Col. 6, Lns. 50-58, Col 12, Ln. 52—Col. 13, Ln 7 teaches that the recommendation determined and provided (ascribed) is to refrain from eating a meal (interpreted as a treatment), which is related to forgoing an insulin dose because an insulin dose would not be needed to account for the meal.]
REGARDING CLAIM 4
Bik teaches the claimed database management system of Claim 1. Bik may not explicitly teach
[…]; the newly received glucose measurement trace is from:
an individual that has low risk of the specified physiological disorder and not diagnosed with the specified physiological disorder;
an individual that has high risk of the specified physiological disorder and not diagnosed with the specified physiological disorder; or
an individual diagnosed with the specified physiological disorder. [Col. 5, Lns. 41-45 teaches that the user for whom the physiological data is collected has diabetes.]
Bik may not teach that the physical data store contains
the physical data store contains glucose measurement data from one or more of:
individuals that have low risk of the specified physiological disorder and not diagnosed with the specified physiological disorder;
individuals that have high risk of the specified physiological disorder and not diagnosed with the specified physiological disorder; or
individuals diagnosed with the specified physiological disorder;
However, the limitation claims information/labels that constitute nonfunctional descriptive information that is/are not functionally involved in the recited system. The function described by the system would be performed the same regardless of whether the claimed information/labels was substituted with nothing. Because the Bik teaches a database storing data having data labels, substituting the information/labels of the claimed invention for the information/labels of the prior art would be an obvious substitution of one known element for another, producing predictable results. Therefore, would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have substituted the information/labels applied to the stored data of the prior art with any other information/labels because the results would have been predictable. MPEP 2112.01, Section III (see also In re Ngai, Ex Parte Breslow). As with Claim 1, the Examiner notes that the optional feature that utilized particularly-recited types of data (“classify the newly received glucose measurement trace by either…or by searching the physical data store…”) was not selected, the data in the physical data store is not required by the claim and the data that is stored is thus non-functional with respect to the claim.
REGARDING CLAIM 5
Bik teaches the claimed database management system of Claim 1. Bik further teaches
the specified physiological disorder is diabetes; and [Col. 5, Lns. 41-45 teaches that the user for whom the physiological data is collected has diabetes.]
Bik may not explicitly teach
the autoantibody is an islet antibody.
However, the limitation claims information/labels that constitute nonfunctional descriptive information that is/are not functionally involved in the recited system. The function described by the system would be performed the same regardless of whether the claimed information/labels was substituted with nothing. Because the Bik teaches a database storing data having data labels, substituting the information/labels of the claimed invention for the information/labels of the prior art would be an obvious substitution of one known element for another, producing predictable results. Therefore, would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have substituted the information/labels applied to the stored data of the prior art with any other information/labels because the results would have been predictable. MPEP 2112.01, Section III (see also In re Ngai, Ex Parte Breslow). As with Claim 1, the Examiner notes that the optional feature that utilized particularly-recited types of data (“classify the newly received glucose measurement trace by either…or by searching the physical data store…”) was not selected, the data in the physical data store is not required by the claim and the data that is stored is thus non-functional with respect to the claim.
REGARDING CLAIM 6
Bik teaches the claimed database management system of Claim 1. Bik further teaches
the similarity metric is a score that is a probability that the newly received glucose measurement trace is classified as autoantibody positive or autoantibody negative. [The Examiner notes that the similarity metric feature is optional in Claim 1 and the Examiner did not take that option. As such, this non-selected, optional feature is not addressed.]
Bik may not explicitly teach
the representation is an estimate that the glucose measurement trace is classified as autoantibody positive or autoantibody negative; and
However, the limitation claims information/labels that constitute nonfunctional descriptive information that is/are not functionally involved in the recited system. The function described by the system would be performed the same regardless of whether the claimed information/labels was substituted with nothing. Because the Bik teaches a database storing data having data labels, substituting the information/labels of the claimed invention for the information/labels of the prior art would be an obvious substitution of one known element for another, producing predictable results. Therefore, would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have substituted the information/labels applied to the stored data of the prior art with any other information/labels because the results would have been predictable. MPEP 2112.01, Section III (see also In re Ngai, Ex Parte Breslow). As with Claim 1, the Examiner notes that the optional feature that utilized particularly-recited types of data (“classify the newly received glucose measurement trace by either…or by searching the physical data store…”) was not selected, the data in the physical data store is not required by the claim and the data that is stored is thus non-functional with respect to the claim.
REGARDING CLAIM 7
Bik teaches the claimed database management system of Claim 1. Bik further teaches
in combination with a glucose measurement device, [Col. 2. Lns. 42-60, Col. 8, Lns. 40-47 teaches a blood glucose monitoring device in the form of a CGM.] wherein:
the glucose measurement device is configured to generate the glucose measurement for the newly received glucose measurement trace; and [Col. 8, Lns. 40-47 teaches that the CGM provides continuous measurements. “[F]or the newly received glucose measurement trace” is an intended use and is not required for occur.]
the glucose measurement device is in communication with the processor the newly received glucose measurement trace [Fig. 2, items 202 and 222. Col. 8, Lns. 40-47 teach that the CGM communicates with the diabetes management platform computer and thus processor.] or in communication with a data store that is in communication with the processor.
REGARDING CLAIM 8
Bik teaches the claimed database management system of Claim 1. Bik further teaches
the glucose measurements of the newly received glucose measurement trace is continuous glucose measurement data. [Col. 2. Lns. 42-60, Col. 8, Lns. 40-47 teaches a blood glucose monitoring device in the form of a CGM. Col. 8, Lns. 40-47 teaches that the CGM provides continuous measurements.]
Bik may not explicitly teach
the glucose measurement data contained in the physical data store is continuous glucose measurement data; and
However, the limitation claims information/labels that constitute nonfunctional descriptive information that is/are not functionally involved in the recited system. The function described by the system would be performed the same regardless of whether the claimed information/labels was substituted with nothing. Because the Bik teaches a database storing data having data labels, substituting the information/labels of the claimed invention for the information/labels of the prior art would be an obvious substitution of one known element for another, producing predictable results. Therefore, would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have substituted the information/labels applied to the stored data of the prior art with any other information/labels because the results would have been predictable. MPEP 2112.01, Section III (see also In re Ngai, Ex Parte Breslow). As with Claim 1, the Examiner notes that the optional feature that utilized particularly-recited types of data (“classify the newly received glucose measurement trace by either…or by searching the physical data store…”) was not selected, the data in the physical data store is not required by the claim and the data that is stored is thus non-functional with respect to the claim.
REGARDING CLAIM 9
Bik teaches the claimed database management system of Claim 1. Bik further teaches
the newly received glucose measurement trace is a compilation of glucose measurements taken for seven days. [Col. 4, Lns. 20-27 teaches that excursions are identified over extended durations such as weeks or months (which necessarily includes 7 days) thus such data is collected. Col. 16, Lns. 29-38, Col. 17, Lns. 42-50 teaches collecting values over a week.]
Bik may not explicitly teach
the glucose measurement trace of the glucose measurement data contained in the physical data store is a compilation of glucose measurements taken for seven days; and
However, the limitation claims information/labels that constitute nonfunctional descriptive information that is/are not functionally involved in the recited system. The function described by the system would be performed the same regardless of whether the claimed information/labels was substituted with nothing. Because the Bik teaches a database storing data having data labels, substituting the information/labels of the claimed invention for the information/labels of the prior art would be an obvious substitution of one known element for another, producing predictable results. Therefore, would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have substituted the information/labels applied to the stored data of the prior art with any other information/labels because the results would have been predictable. MPEP 2112.01, Section III (see also In re Ngai, Ex Parte Breslow). As with Claim 1, the Examiner notes that the optional feature that utilized particularly-recited types of data (“classify the newly received glucose measurement trace by either…or by searching the physical data store…”) was not selected, the data in the physical data store is not required by the claim and the data that is stored is thus non-functional with respect to the claim.
REGARDING CLAIM 10
Bik teaches the claimed database management system of Claim 1. Bik further teaches
wherein instructions cause the processor to one or more of:
store the classification of the newly received glucose measurement trace in a data store that is in communication with one or more of
a predictive modeling system, [Fig. 9, Col. 21, Lns. 3-11, Col. 24, Lns. 14-17 teaches annotation of an unlogged meal event (i.e., a meal that was classified; a new event) and that annotations are stored in a database. The database is in communication with the processor.]
a decision support system,
an insulin delivery system,
an insulin monitoring system, or
an automated control system configured to use the classification or representation as input;
transmit the classification of the newly received glucose measurement trace to one or more of
a predictive modeling system,
a decision support system,
an insulin delivery system,
an insulin monitoring system, or
an automated control system configured to use the classification or representation as input; or
monitor, analyze, or influence a concentration of glucose levels in a fluid using the classification of the newly received glucose measurement trace. [Col. 6, Lns. 50-58, Col 12, Ln. 52—Col. 13, Ln 7 teaches that the classification of a meal causes a recommendation to be presented which influences the future glucose levels in the blood because the use doesn’t eat the meal.]
REGARDING CLAIM 11
Bik teaches the claimed database management system of Claim 1. Bik further teaches
wherein: the classification of the glucose measurement data contained in the physical data store is based on one or more classifier models including
a linear discriminant analysis (LDA) technique,
a linear support vector machine (SVM) technique,
a logistic regression (LR) technique, or
a K-nearest neighbors (KNN) technique; and
the one or more classifier models generates or extracts one or more glucose measurement metric from the glucose measurement data, the one or more glucose measurement metric including:
a mean glucose (MG) value;
a percent of time in range glucose value;
a coefficient of variation (CV) glucose value;
a standard deviation (SD) glucose value;
a glucose range;
a low blood glucose index (LBGI) for hypoglycemia;
a high blood glucose index (HBGI) for hypoerglycemia;
an average daily risk range (ADRR) for hypo- and hyperglycemia; and/or
an overnight incremental area under the curve (IAUC) value. [The Examiner notes that the classification using a similarity metric feature is optional in Claim 1 and the Examiner did not take that option. As such, this non-selected, optional feature is not addressed.]
REGARDING CLAIM 12
Bik teaches the claimed database management system of Claims 1 and 11. Bik further teaches
the percent of time in range glucose value is based on glucose measurements falling within one or more time ranges. [The Examiner notes that the classification using a similarity metric feature is optional in Claim 1 and the Examiner did not take that option. As such, this non-selected, optional feature is not addressed.]
REGARDING CLAIM 13
Bik teaches the claimed database management system of Claims 1, 11, and 12. Bik further teaches
wherein: the one or more time ranges includes:
percentage of time glucose measurements are >180 mg/dl (T180);
percentage of time glucose measurements are >160 mg/dl (T160);
percentage of time glucose measurements are >140 mg/dl (T140); and
percentage of time glucose measurements are <70 mg/dl (T70); and
percentage of time glucose measurements are <54 mg/dl (T54). [The Examiner notes that the classification using a similarity metric feature is optional in Claim 1 and the Examiner did not take that option. As such, this non-selected, optional feature is not addressed.]
REGARDING CLAIM 14
Bik teaches the claimed database management system of Claim 1. Bik further teaches
the physical data store includes […data…]. [Col. 17, Lns. 42-44, Col. 26, Lns. 23-25 teaches a database (a physical data store) storing data. Alternately or in addition, Col. 31, Lns. 20-58 teaches memory (a physical data store) storing data.]
[…] wherein the classification is further based on the c-peptide data. [The Examiner notes that the classification using a similarity metric feature is optional in Claim 1 and the Examiner did not take that option. As such, this non-selected, optional feature is not addressed.]
Bik may not explicitly teach
c-peptide data associated with the controlled glycemic-response consumption activity, wherein the classification is further based on the c-peptide data.
However, the limitation claims information/labels that constitute nonfunctional descriptive information that is/are not functionally involved in the recited system. The function described by the system would be performed the same regardless of whether the claimed information/labels was substituted with nothing. Because the Bik teaches a database storing data having data labels, substituting the information/labels of the claimed invention for the information/labels of the prior art would be an obvious substitution of one known element for another, producing predictable results. Therefore, would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have substituted the information/labels applied to the stored data of the prior art with any other information/labels because the results would have been predictable. MPEP 2112.01, Section III (see also In re Ngai, Ex Parte Breslow). As with Claim 1, the Examiner notes that the optional feature that utilized particularly-recited types of data (“classify the newly received glucose measurement trace by either…or by searching the physical data store…”) was not selected, the data in the physical data store is not required by the claim and the data that is stored is thus non-functional with respect to the claim.
REGARDING CLAIM(S) 17
Claim(s) 17 is/are analogous to Claim(s) 1, thus Claim(s) 17 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
REGARDING CLAIM(S) 18 AND 20
Claim(s) 18 and 20 is/are analogous to Claim(s) 2 and 4, respectively, thus Claim(s) 18 and 20 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 2 and 4.
Claim(s) 3 and 19 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Bikhchandani et al. (hereinafter “Bik;” U.S. Patent No. 11,166,670) in view of Vleugels et al. (U.S. Pre-Grant Patent Publication No. 2020/0289373).
REGARDING CLAIM 3
Bik teaches the claimed database management system of Claim 1. As best understood by the Examiner, Bik may not explicitly teach
wherein: the controlled glycemic-response consumption activity includes consumption of an energy drink in lieu of a meal.
Vleugels at Para. 0104 teaches that it was known in the art of diabetes management, at the time of filing, to monitor food intake / meal information for a person being treated for diabetes has eaten where a meal may be an energy drink
wherein: the controlled glycemic-response consumption activity includes consumption of an energy drink in lieu of a meal. [Para. 0104 teaches that a meal consumed while monitoring a patient’s diabetes may be an energy drink.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the glycemic health state determination taking into account meals of Bik to monitor what type of meal a person being treated for diabetes has eaten where a meal may be an energy drink as taught by Vleugels, with the motivation of improving eating event detection (see Vleugels at Para. 0007).
The Examiner also notes that the meal being an energy drink likely represents non-functional descriptive information; however, Vleugels has been cited for completeness.
REGARDING CLAIM(S) 19
Claim(s) 19 is/are analogous to Claim(s) 3, thus Claim(s) 19 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 3.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Bikhchandani et al. (hereinafter “Bik;” U.S. Patent No. 11,166,670) in view of Johnson et al. (U.S. Pre-Grant Patent Publication No. 2023/0263434).
REGARDING CLAIM 15
Bik teaches the claimed database management system of Claims 1 and 14. Bik may not explicitly teach
wherein: the instructions cause the processor to receive c-peptide measurements to generate newly received c-peptide data.
Johnson at 0078, 0080, 0113 teaches that it was known in the art of diabetes management, at the time of filing, to collect patient physiological data in the form of c-peptide data
wherein: the instructions cause the processor to receive c-peptide measurements to generate newly received c-peptide data. [Johnson at Para. 0080 teaches than an analyte sensor transmits analyte data to a display device (the computer having a processor of Bik). Johnson at Para. 0078, 0113 teaches that one of the analytes monitored is c-peptide.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the glycemic health state determination taking into account meals of Bik to collect patient physiological data in the form of c-peptide data as taught by Johnson, with the motivation of improving the detections od diabetes-related issues (see Johnson at Para. 0055).
REGARDING CLAIM 16
Bik/Johnson teaches the claimed database management system of Claims 1, 14, and 15. Bik/Johnson further teaches
in combination with a c-peptide measurement device, [Johnson at Para. 0080, 0113 teaches than an analyte sensor that measures c-peptide.]
wherein: the c-peptide measurement device is configured to generate the newly received c-peptide data; [Johnson at Para. 0056, 0080 teaches that the analyte sensor collects data continuously, thus it is configured to generate new data.]
the c-peptide device measurement device is in communication with the processor or in communication with a data store that is in communication with the processor. [Johnson at Para. 0080 teaches than an analyte sensor transmits analyte data to a display device (the computer having a processor of Bik).]
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Berg et al. (U.S. Pre-Grant Patent Publication No. 2025/0035558) which discloses a system for individualizing analyte value ranges using a mobile device.
Liu et al. (U.S. Pre-Grant Patent Publication No. 2021/0290113) which discloses an automated coaching system for measured glucose states to generate and optimum pathway to reach an ideal state.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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