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 .
Status of the Claims
Claims 1-14, 20, and 22-25 are pending and examined herein.
Claims 15-19 and 21 are canceled.
Priority
As detailed on the 11 June 2024 filing receipt, the application claims priority as early as 05 May 2021 to provisional application 63/184,560. At this point in examination, all claims have been interpreted as being accorded this priority date as the effective filing date.
Information Disclosure Statement
Information disclosure statement (IDS) was filed on 12 March 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the references are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: homeostasis is misspelled as “homestasis” (pg 11, paragraph [45]) and suitable is misspelled as “suitbale” (pg. 58, paragraph [302]).
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because the claim recites an A1 metric for males and females, where being below the metric is a weak phenotype for males and a poor phenotype for females. The condition is assumed to connote the same type of condition for males and females but has inconsistent terminology.
Claims 8 and 10 are objected to because of the following informality: the list element demarcations including periods. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). MPEP 608(m) pertains. Amendment to replace with hyphens or parentheticals around the letters would overcome this objection.
Claim 20 is objected to because of the following informality: the “generate” step ends in a period rather than a semicolon. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-14, 20, and 22-25 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.
Claim 1 recites generating a model and classifying the subject. However, the relationship between the elements is unclear as the elements lack a conjunction such as “and” joining the elements clarifying that both are required. Dependent claims 2-14 are rejected on similar grounds.
Claim 13 is also rejected because the list elements are not joined by “and” or “or”, making it unclear which list elements are required. Dependent claim 14 is rejected on similar grounds.
Claim 20 is also rejected because the list elements are not joined by “and” or “or”, making it unclear which list elements are required. Dependent claims 22-25 are rejected on similar grounds.
Claim 22 is also rejected because the list elements are not joined by “and” or “or”, making it unclear which list elements are required. Dependent claims 23-25 are rejected on similar grounds.
Claim 25 contains the trademark/trade name FreeStyleTM Libre. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a glucose measurement device and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 24 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 24 depends on claim 23, but claim 24 appears to recite the same limitations as claim 23, and thus fails to further limit its parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-14, 20, and 22-25 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). The claims as a whole, considering all claim elements individually and in combination, are directed to a judicial exception at Step 2A, Prong 2, and the additional elements of the claims, considered individually and in combination, do not provide significantly more at Step 2B than the abstract idea of classifying a subject into a glucose homeostasis phenotype.
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of
nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The claims are directed to a method (claims 1-14) and a computer system (claims 20 and 22-25), each of which falls within one of the categories of statutory subject matter. [Step 1: Yes]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Claim 1 recites generating a homeostasis model with a number of numerical parameters, interpreted as a written presentation of a mathematical concept.
Claims 1 and 20 recite classifying a subject, which a mental step of data evaluation, based on the model.
Claims 2-3 recite classifying steps specifically based on A1, which are mental steps of data evaluation.
Claim 4-5 recite classifying steps specifically based on A2/λ, which are mental steps of data evaluation.
Claims 6-7 recite additional information about the subject, where information about the subject is data per se and thus abstract.
Claims 8 and 10 recite classification into subphenotypes based on sex and parameters, where classification is a mental step of data evaluation.
Claims 9 and 11 recite selecting an individual, where making a selection is a mental step.
Claim 12 recites at least monitoring a subject, where monitoring reads on collecting additional data based on the abstract steps discussed above.
Claims 13, 20, and 22 recite selecting curve intervals, where making a selection is a step practically performed by the human mind.
Claims 13, 20, and 22 recite determining a representative curve, which is interpreted as making a selection and thus also a mental process.
Claims 13, 20, and 22 recite determining a proportional coefficient, an integral coefficient, a time scale, and steady depletion coefficient based on the curves, which are descriptions of mathematical processes.
Claims 13, 20, and 22 recite generating a model based on the parameters, where generating a model based on mathematical values is a mathematical concept.
Claims 14 and 23-24 recite determining a metric based on the parameters, where determining a metric is a mathematical concept.
Thus, the claims recite abstract ideas and thus must be examined further to determine whether elements in addition to the abstract ideas integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). [Step 2A Prong One: Yes]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Because the claims recite judicial exceptions, direction under Step 2A Prong Two provides that the claims must be examined further to determine whether they recite elements in addition to the abstract ideas which integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d)(III)).
Additional elements that are not abstract ideas include a processor (claims 13 and 20), receiving measurements from a glucose measurement device (claims 13 and 22), memory coupled to a glucose measurement device (claim 20), and a glucose measuring device (claim 25).
The claims comprising computer components of a processor and memory do not describe any specific computational steps by which the computer performs or carries out the abstract idea, nor do they provide any details of how specific structures of the computer are used to implement these functions. The claims state nothing more than that a generic computer performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
Receiving data in the form of glucose measurements is a data gathering step to perform the abstract mathematical and mental steps. Data gathering is considered insignificant extra-solution activity and thus does not integrate the abstract ideas into a practical application (MPEP 2106.05(g)). Similarly, the glucose measurement device is for data collecting and thus related to insignificant extra solution activity.
Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are directed to that abstract idea. Claims that are directed to abstract ideas must be examined further to determine whether the additional elements besides the abstract idea render the claims significantly more than the abstract idea. Claims that are directed to abstract ideas and that raise a concern of preemption of those abstract ideas must be examined to determine what elements, if any, they recite besides the abstract idea, and whether these additional elements constitute inventive concepts that are sufficient to render the claims significantly more than the abstract idea (MPEP 2106.05). [Step 2A Prong Two: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
Additional elements that are not abstract ideas include a processor (claims 13 and 20), receiving measurements from a glucose measurement device (claims 13 and 22), memory coupled to a glucose measurement device (claim 20), and a glucose measuring device (claim 25).
The claims recite a computer, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions, which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
The courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), 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), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93 (storing and retrieving information in memory), as discussed in MPEP 2106.05(d)(II)(i)).
Nath (IFAC 51(1): 289-294, 2018; newly cited) teaches in a review of physiological models and control of type 1 diabetes the use of a continuous glucose monitor as part of an artificial pancreas system to monitor blood sugar and infuse insulin based on a control algorithm (pg. 289, Section 1).
Therefore, the recited additional elements, alone or in combination, do not appear to provide an inventive concept. [Step 2B: No]
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole,
are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not
constitute significantly more than the abstract idea, so the claims are rejected under 35 USC § 101 as
being directed to non-statutory subject matter.
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 20, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over van Veen (arXiv 1912.13184, 9 pgs., 2019; previously cited on the 12 March 2024 IDS form).
Claim 1 recites generating a glucose homeostasis model for the subject based on a plurality of
glucose measurements for the subject, wherein the glucose homeostasis model comprises a proportional coefficient A1 for response of a controller u(t) to an error e(t), an integral coefficient A2 for response of the controller u(t) to past values of error e(t), an inverse memory time scale λ for decay of an integral term, a steady depletion coefficient A3 for a basic metabolic rate, and a feedback coefficient A4 for an
approximate mass action rate.
Van Veen teaches the parameters A1, A2, λ, and A3 in a glucose homeostasis model (pg. 4, Table I) and A4, disclosed as a feedback coefficient for an approximate mass action rate, as a “feedback term takes the form of mass action” (pg. 3, last paragraph) as well as controller response to an error coefficients u(t) and e(t) in Figure 3.
Claim 1 recites classifying the subject into the glucose homeostasis phenotype based on one or
more of A1, A2, λ, A3 and A4.
Van Veen teaches speculation regarding using indicators from the model to diagnose a pathological state such as prediabetes (pg. 7, second paragraph), where prediabetes is interpreted as a homeostasis phenotype.
Claim 2 recites classifying the subject based on a value for A1.
Van Veen teaches a proportional-integral control, coupled to a rudimentary model of blood glucose kinetics, can effectively describe homeostatic control (pg. 3, Section III), where a decision is at least partially based on A1 (Fig 3).
Claim 20 recites a memory, the memory comprising a plurality of glucose measurements for
the patient, the plurality of glucose measurements for the patient comprising a time-series collected from the patient using a glucose measurement device.
Claim 20 recites a processor in communication with the memory, the processor configured to: select one or more curve intervals in the plurality of glucose measurements, the one or more curve intervals corresponding to one or more local maxima of the plurality of glucose measurements; determine a representative curve based on the one or more curve intervals; - determine a proportional coefficient A1 for response of a controller u(t) to an error e(t), an integral coefficient A2 for response of the controller
u(t) to past values of error e(t), an inverse memory time scale λ for decay of an integral term, a steady depletion coefficient A3 for a basic metabolic rate, and a feedback coefficient A4 for an approximate mass action rate; - generate the glucose homeostasis model, the glucose homeostasis model comprising the proportional coefficient A1, the integral coefficient A2, the inverse memory time scale λ, the steady depletion coefficient A3, and the feedback coefficient A4; classify the subject into the glucose homeostasis phenotype based on one or more of based on one or more of A1, A2, λ, A3 and A4.
Van Veen teaches determination of a representative curve based on intervals (Fig. 1) and the parameters A1, A2, λ, and A3 in a glucose homeostasis model (pg. 4, Table I) and A4, disclosed as a feedback coefficient for an approximate mass action rate, as a “feedback term takes the form of mass action” (pg. 3, last paragraph) as well as controller response to an error coefficients u(t) and e(t) in Figure 3.
Claim 22 recites the processor is configured to generate the glucose homeostasis model for the subject by receiving a plurality of glucose measurements in a time series from the patient and performing the steps of claim 20.
Van Veen teaches the limitations of claim 20 as well as application to a time series of data from an individual (Fig. 2 caption).
Claims 23-24 recite the processor is further configured to determine a glucose homeostasis metric based on one or more of the group of the proportional coefficient A1, the integral coefficient A2, the steady depletion coefficient A3, the feedback coefficient A4, and the inverse memory time scale term λ, wherein the glucose homeostasis metric is A1 or A2/λ.
Van Veen teaches determination of a representative curve based on intervals (Fig. 1) and the parameters A1, A2, λ, and A3 in a glucose homeostasis model (pg. 4, Table I) and A4, disclosed as a feedback coefficient for an approximate mass action rate, as a “feedback term takes the form of mass action” (pg. 3, last paragraph) as well as controller response to an error coefficients u(t) and e(t) in Figure 3. Van Veen teaches using A1 as a metric for determining response (pg. 5, fourth paragraph).
Claim 25 recites the plurality of glucose measurements are received from a glucose measurement device and optionally wherein the glucose measurement device is a FreestyleTM Libre.
Van Veen teaches use of the glucose monitor FreeStyle Libre (pg. 2, fourth paragraph).
Van Veen teaches the model recited in the instant claims for modeling glucose homeostasis. Van Veen teaches speculation regarding using indicators from the model to diagnose a pathological state such as prediabetes but not actually doing so because the participants were not diagnosed with a condition (pg. 7, second paragraph). However, van Veen also points to existing metrics for diagnosing glucose uptake, like HbA1C, to diagnose healthy patients from those with diabetes or prediabetes (pg. 2, third paragraph). Therefore, use of participants with a known condition to validate the speculation about van Veen’s modeling by classifying the individuals into pathological categories also taught by van Veen would be prima facie obvious (MPEP 2143 B).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over van Veen as applied to claims 1-2, 20, and 22-25 above and further in view if Varlamov (Frontiers in Endocrinology 5(241): 1-7, 2015; newly cited).
Claim 3 recites the subject is a male subject and a subject with a value of A1 less than 0.25 is classified as having a weak instantaneous glucose response phenotype or wherein the subject is a female subject and a subject with a value A1 less than 0.30 is classified as having a poor instantaneous glucose
response phenotype.
Van Veen teaches a decision is at least partially based on A1 (Fig 3) but does not note sex-based differences in homeostatic variables.
Varlamov teaches sex-specific differences in glucose metabolism (pg. 2, col. 2, second paragraph).
It would be prima facie obvious to combine the work of van Veen and Varlamov because van Veen teaches the model required but does not teach sex-based differences in glucose homeostasis. Varlamov teaches sex-specific differences in glucose metabolism, with estrogen, muscle fiber density, and fat being likely rationales for differences (pg. 2, col. 2, second paragraph). Furthermore, while the exact parameters for what is considered poor or weak are not taught, routine optimization of the model parameters as results-effective variables for male and female subjects may, in view of Varlamov, result in different values for the parameters based on sex.
Claims Free of the Prior Art
Claims 4-14 are considered free of the prior art. The closest prior art, van Veen, teaches the parameters required by the claims but does not teach classifying a subject based on A2/λ or the classification of 0.6 as indicative of weak inertial glucose response. Therefore, these claims and all claims dependent on them are not considered taught or fairly suggested by the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert J Kallal whose telephone number is (571)272-6252. The examiner can normally be reached Monday through Friday 8 AM - 4 PM EST.
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/Robert J. Kallal/Examiner, Art Unit 1685
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