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 .
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 3-7, 9 and 15-17 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 3 recites “the GK Ratio being chosen from: GK Ratio 1 = GL/KL, GK Ratio 2 = GV/KV, GK Mixed Ratio 1 = GL/KV, and GK Mixed Ratio 2 = GV/KL”. It is unclear whether the GK ratio is a combination of all four ratios or just one of the four listed. For the purposes of examination, it will be interpreted that only one is chosen.
Claim 4 recites “LG Ratio 1 = GL/LL, LG Ratio 2 = GV/LV, LG Mixed Ratio 1 = GL/LV, and LG Mixed Ratio 2 = GV/LL”. It is unclear whether the LG ratio is a combination of all four ratios or just one of the four listed. For the purposes of examination, it will be interpreted that only one is chosen.
Claim 5 recites “LK Ratio 1 = LL/KL, LK Ratio 2 = LV/KV, LK Mixed Ratio 1 = LL/KV, and LK Mixed Ratio 2 = LV/KL”. It is unclear whether the LK ratio is a combination of all four ratios or just one of the four listed. For the purposes of examination, it will be interpreted that only one is chosen.
Claim 6 recites “Global Metric K1 = A*KV + B*KL, Global Metric K2 = (A*KV)/(B*KL), Global Metric K3 = (A*KL)/(B*KV), and Global Metric K4 = {(A*KL)/(KROC)}*Ketone Ratio”. It is unclear whether the Global Metric ratio is a combination of all four ratios or just one of the four listed. For the purposes of examination, it will be interpreted that only one is chosen.
Claim 7 recites “Global Metric L1 = A*LV + B*LL, Global Metric L2 = (A*LV)/(B*LL), Global Metric L3 = (A*LL)/(B*LV), and Global Metric L4 = {(A*LL)/(LROC)}*Lactate Ratio”. It is unclear whether the Global Metric ratio is a combination of all four ratios or just one of the four listed. For the purposes of examination, it will be interpreted that only one is chosen.
Claim 9 recites “Global Mixed Metric 1 =A*GV+B*KV +C*GL + D*PPP, Global Mixed Metric 2 = A*GV+B*KV +C*KL + D*PPP, Global Mixed Metric 3 = A*GL/KL, Global Mixed Metric 4 = A*GV/KV, Global Mixed Metric 5 = A*GROC/KROC, and Global Mixed Metric 6 = A*GL/KL + B*GV/KV + C*GROC”. It is unclear whether the Global Metric ratio is a combination of all six ratios or just one of the six listed. For the purposes of examination, it will be interpreted that only one is chosen.
Claim 15 recites “the GK Ratio being chosen from: GK Ratio 1 = GL/KL, GK Ratio 2 = GV/KV, GK Mixed Ratio 1 = GL/KV, and GK Mixed Ratio 2 = GV/KL”. It is unclear whether the GK ratio is a combination of all four ratios or just one of the four listed. For the purposes of examination, it will be interpreted that only one is chosen.
Claim 16 recites “LG Ratio 1 = GL/LL, LG Ratio 2 = GV/LV, LG Mixed Ratio 1 = GL/LV, and LG Mixed Ratio 2 = GV/LL”. It is unclear whether the LG ratio is a combination of all four ratios or just one of the four listed. For the purposes of examination, it will be interpreted that only one is chosen.
Claim 17 recites “LK Ratio 1 = LL/KL, LK Ratio 2 = LV/KV, LK Mixed Ratio 1 = LL/KV, and LK Mixed Ratio 2 = LV/KL”. It is unclear whether the LK ratio is a combination of all four ratios or just one of the four listed. For the purposes of examination, it will be interpreted that only one is chosen.
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 an abstract idea without significantly more.
Claims 1-20 are all within at least one of the four categories.
The independent claim 1 recites recite:
calculating, by the processor, a global metric that is based on i) the glucose data and the ketone data, ii) the glucose data and the lactate data, iii) the ketone data and the lactate data; or iv) the glucose data, the ketone data and the lactate data;
determining, by the processor, an individualized metric by correlating the food intake information and the physical activity information to the global metric; and
recommending, by the processor, a behavior modification based on the individualized metric
The independent claim 13 recites recite:
calculating, by the processor, a global metric, the global metric being an indicator ratio comprising at least two of the glucose data, the ketone data, and the lactate data;
determining, by the processor, an individualized metric by correlating the food intake information and the physical activity information to the global metric; and
recommending, by the processor, a behavior modification based on the individualized metric.
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019. See footnotes 14 and 15.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018) (performing a resampled statistical analysis to generate a resampled distribution).
The claimed steps of calculating, determining and recommending can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
With respect to the pending claims, for example, an experienced physician can perform the claimed step of calculating a global metric by mentally calculating a ratio using collected data. The experienced physician can then determine an individualized metric by mentally looking at food intake information and physical activity information based on calculated global metric and further mentally note a recommendation of a behavior medication based on the individual metric. Thus, the claims can be readily interpreted as being a mere application of a mental process on a computer.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. For example, dependent claims 2-12 and 14-20 recite steps (e.g. calculating; and determining) that can be performed in the mind. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
This judicial exception (abstract idea) in claims 1-20 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for calculating, determining and recommending merely invoke a computer as a tool.
The data-gathering step (receiving) does not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for receiving, calculating, determining and recommending.
The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide information about collected data.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for receiving, calculating, determining and recommending. The claims do not apply the obtained data to a particular machine. Rather, the data is merely output in an post-solution step.
The additional elements are identified as follows: a processor; a metabolic sensor; and a continuous metabolic monitoring device.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant' s Background in the specification;
Applicant' s specification (para [0073]-[0076]) which discloses that the processor comprise generic computer components that are configured to perform the generic computer functions (e.g. receiving, calculating, determining and recommending) that are well-understood, routine, and conventional activities previously known to the pertinent industry;
the non-patent literature cited by applicant in IDS filed February 23, 2023; and
the non-patent literature cited herewith:
Vu, Tri, et al. "Wearable food intake monitoring technologies: A comprehensive review." Computers 6.1 (2017): 4.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 8, 10-14 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayter (US 20170128007 A1; cited by applicant).
With respect to claim 1, Hayter discloses a method (see paragraph 0079 and Fig. 3A, method #300) comprising:
receiving (see paragraph 0082, receiving analyte data; and see paragraph 0081, analyte data is monitored at step 304), by a processor (see paragraph 0079, method may be performed by a processor), data associated with an individual from a metabolic sensor (see paragraph 0040-0041, analyte sensor #104), the data comprising at least two of glucose data, ketone data and lactate data (see paragraph 0030, analyte can be glucose of a user; and see paragraph 0205, analytes that may be monitored also includes glucose, ketone and lactate which can be monitored at the same or different times);
receiving, by the processor, food intake information and physical activity information associated with the individual (see paragraph 0082, logging of meal information by the user; and see Fig. 3A #302 and #312; and see paragraph 0169, information about user’s activity level is collected);
calculating, by the processor, a global metric that is based on i) the glucose data and the ketone data, ii) the glucose data and the lactate data, iii) the ketone data and the lactate data; or iv) the glucose data, the ketone data and the lactate data (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times; and see Fig. 3A #314 and #316);
determining, by the processor, an individualized metric by correlating the food intake information and the physical activity information to the global metric (see paragraph 0137, the meal event detector outputs information about the glycemic response to the meal that is used to characterize the magnitude of the response and the difference in the glucose values can provide a delta glucose measure of the glycemic response; and see paragraph 0136, analyte data corresponding to the meal event; and see paragraph 0169, information about user’s activity level is collected; and see Fig. 3A #318); and
recommending, by the processor, a behavior modification based on the individualized metric (see paragraph 0149, a medication or treatment output can be issued; and see Fig. 3A #320).
With respect to claim 2, all limitations of claim 1 apply in which Hayter further discloses
the glucose data comprises a glucose variability (GV) (see paragraph 0136, glycemic impact is determined quantitatively in terms of glucose level), a glucose load (GL) (see paragraph 0136, glycemic impact is determined quantitatively in terms of the median and mean glucose level; the instant applicant states in paragraph 0038 that the glucose load is the mean glucose level), and a post-prandial peak (PPP) (see paragraph 0136, glycemic impact is determined quantitatively in terms of a maximum peak of glucose; and see paragraph 0137, meal glucose peaks);
the ketone data comprises a ketone load (KL) and a ketone variability (KV) (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times; and see Fig. 3A #314 and #316; and see paragraph 0136, glycemic impact is determined quantitatively in terms of the median and mean glucose level; the instant applicant states in paragraph 0038 that the glucose load is the mean glucose level; and see paragraph 0136, glycemic impact is determined quantitatively in terms of a maximum peak of glucose; and see paragraph 0137, meal glucose peaks); and
the lactate data comprises a lactate load (LL) and lactate variability (LV) (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times; and see Fig. 3A #314 and #316; and see paragraph 0136, glycemic impact is determined quantitatively in terms of the median and mean glucose level; the instant applicant states in paragraph 0038 that the glucose load is the mean glucose level; and see paragraph 0136, glycemic impact is determined quantitatively in terms of a maximum peak of glucose; and see paragraph 0137, meal glucose peaks).
With respect to claim 8, all limitations of claim 2 apply in which Hayter further discloses wherein the global metric further comprises a ketone rate of change (ROC) or a lactate ROC (see paragraph 0074 and 0084, rate of change of analyte is determined and the rate of change of glucose is utilized by meal event detector; and see paragraph 0205, the analyte may be glucose, ketone or lactate monitored at the same or different times), wherein the ketone ROC or the lactate ROC is used in the determining of the individualized metric (see paragraph 0084, the rate of change of glucose is utilized by meal event detector; see paragraph 0137, the meal event detector outputs information about the glycemic response to the meal that is used to characterize the magnitude of the response and the difference in the glucose values can provide a delta glucose measure of the glycemic response; and see paragraph 0136, analyte data corresponding to the meal event; and see paragraph 0169, information about user’s activity level is collected; and see Fig. 3A #318).
With respect to claim 10, all limitations of claim 1 apply in which Hayter further discloses
the calculating comprises calculating a plurality of global metrics (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively; and see Fig. 3A #314 and #316); and
the determining comprises which global metric of the plurality of global metrics to correlate the food intake information and the physical activity information to (see paragraph 0137, the meal event detector outputs information about the glycemic response to the meal that is used to characterize the magnitude of the response and the difference in the glucose values can provide a delta glucose measure of the glycemic response; and see paragraph 0136, analyte data corresponding to the meal event; and see paragraph 0169, meal monitor application can be used with software that monitors information about user’s activity level; and see Fig. 3A #318; and see paragraph 0163, user can compare features of different meals and metrics).
With respect to claim 11, all limitations of claim 1 apply in which Hayter further discloses wherein the data is metabolic data is provided by a continuous metabolic monitoring device (see paragraph 0031, continuous analyte monitoring system and device).
With respect to claim 12, all limitations of claim 1 apply in which Hayter further discloses wherein the behavior modification comprises a food parameter or an exercise parameter (see paragraph 0149, a medication or treatment output can be issued; and see Fig. 3A #320; and see paragraph 0078, meal based treatment; and see paragraph 0199, recommendation as to how a meal can be adjusted such as meal contents, meal times, elimination of snacks, and adjustments to medications).
With respect to claim 13, Hayter discloses a method (see paragraph 0079 and Fig. 3A, method #300) comprising:
receiving (see paragraph 0082, receiving analyte data; and see paragraph 0081, analyte data is monitored at step 304), by a processor (see paragraph 0079, method may be performed by a processor), data associated with an individual from a metabolic sensor (see paragraph 0040-0041, analyte sensor #104), the data comprising at least two of glucose data, ketone data and lactate data (see paragraph 0030, analyte can be glucose of a user; and see paragraph 0205, analytes that may be monitored also includes glucose, ketone and lactate which can be monitored at the same or different times);
receiving, by the processor, food intake information and physical activity information associated with the individual (see paragraph 0082, logging of meal information by the user; and see Fig. 3A #302 and #312; and see paragraph 0169, information about user’s activity level is collected);
calculating, by the processor, a global metric, the global metric being an indicator ratio comprising at least two of the glucose data, the ketone data, and the lactate data (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times; and see Fig. 3A #314 and #316);
determining, by the processor, an individualized metric by correlating the food intake information and the physical activity information to the global metric (see paragraph 0137, the meal event detector outputs information about the glycemic response to the meal that is used to characterize the magnitude of the response and the difference in the glucose values can provide a delta glucose measure of the glycemic response; and see paragraph 0136, analyte data corresponding to the meal event; and see paragraph 0169, information about user’s activity level is collected; and see Fig. 3A #318); and
recommending, by the processor, a behavior modification based on the individualized metric (see paragraph 0149, a medication or treatment output can be issued; and see Fig. 3A #320).
With respect to claim 14, all limitations of claim 13 apply in which Hayter further discloses
the glucose data comprises a glucose variability (GV) (see paragraph 0136, glycemic impact is determined quantitatively in terms of glucose level), a glucose load (GL) (see paragraph 0136, glycemic impact is determined quantitatively in terms of the median and mean glucose level; the instant applicant states in paragraph 0038 that the glucose load is the mean glucose level), and a post-prandial peak (PPP) (see paragraph 0136, glycemic impact is determined quantitatively in terms of a maximum peak of glucose; and see paragraph 0137, meal glucose peaks);
the ketone data comprises a ketone load (KL) and a ketone variability (KV) (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times; and see Fig. 3A #314 and #316; and see paragraph 0136, glycemic impact is determined quantitatively in terms of the median and mean glucose level; the instant applicant states in paragraph 0038 that the glucose load is the mean glucose level; and see paragraph 0136, glycemic impact is determined quantitatively in terms of a maximum peak of glucose; and see paragraph 0137, meal glucose peaks); and
the lactate data comprises a lactate load (LL) and lactate variability (LV) (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times; and see Fig. 3A #314 and #316; and see paragraph 0136, glycemic impact is determined quantitatively in terms of the median and mean glucose level; the instant applicant states in paragraph 0038 that the glucose load is the mean glucose level; and see paragraph 0136, glycemic impact is determined quantitatively in terms of a maximum peak of glucose; and see paragraph 0137, meal glucose peaks).
With respect to claim 18, all limitations of claim 13 apply in which Hayter further discloses
the calculating comprises calculating a plurality of global metrics (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively; and see Fig. 3A #314 and #316); and
the determining comprises which global metric of the plurality of global metrics to correlate the food intake information and the physical activity information to (see paragraph 0137, the meal event detector outputs information about the glycemic response to the meal that is used to characterize the magnitude of the response and the difference in the glucose values can provide a delta glucose measure of the glycemic response; and see paragraph 0136, analyte data corresponding to the meal event; and see paragraph 0169, meal monitor application can be used with software that monitors information about user’s activity level; and see Fig. 3A #318; and see paragraph 0163, user can compare features of different meals and metrics).
With respect to claim 19, all limitations of claim 13 apply in which Hayter further discloses wherein the data is metabolic data is provided by a continuous metabolic monitoring device (see paragraph 0031, continuous analyte monitoring system and device).
With respect to claim 20, all limitations of claim 13 apply in which Hayter further discloses wherein the behavior modification comprises a food parameter or an exercise parameter (see paragraph 0149, a medication or treatment output can be issued; and see Fig. 3A #320; and see paragraph 0078, meal based treatment; and see paragraph 0199, recommendation as to how a meal can be adjusted such as meal contents, meal times, elimination of snacks, and adjustments to medications).
Claim Rejections - 35 USC § 103
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 3-5 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter in view of Simpson (US 20160328991 A1; cited by applicant)
With respect to claim 3, all limitations of claim 2 apply in which Hayter further discloses wherein the global metric comprises a GK Ratio of the glucose data and the ketone data (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times).
Hayter does not specifically disclose the GK Ratio being chosen from: GK Ratio 1 = GL/KL, GK ratio 2 = GV/KV, GK Mixed Ratio 1 = GL/KV, and GK Mixed Ratio 2 = GV/KL.
Simpson teaches a ratio of glucose and ketone (see paragraph 0426).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayter with the teachings of Simpson because it would have resulted in the predictable result of providing an output of a numerical value relating to analytes being measured to a more significant output that is to give a user a level of insight to actionable outputs informing a user of specific steps to take utilizing a ratio of analyte values (Simpson: [0426]).
With respect to claim 4, all limitations of claim 2 apply in which Hayter further discloses wherein the global metric comprises an LG Ratio of the lactate data and the glucose data (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times).
Hayter does not specifically disclose the LG Ratio being chosen from: LG Ratio 1 = GL/LL, LG Ratio 2 = GV/LV, LG Mixed Ratio 1 = GL/LV, and LG Mixed Ratio 2 = GV/LL.
Simpson teaches a ratio of lactate and glucose (see paragraph 0426).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayter with the teachings of Simpson because it would have resulted in the predictable result of providing an output of a numerical value relating to analytes being measured to a more significant output that is to give a user a level of insight to actionable outputs informing a user of specific steps to take utilizing a ratio of analyte values (Simpson: [0426]).
With respect to claim 5, all limitations of claim 2 apply in which Hayter further discloses wherein the global metric comprises an LK Ratio of the lactate data and the ketone data (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times).
Hayter does not specifically disclose the LK Ratio being chosen from: LK Ratio 1 = LL/KL, LK Ratio 2 = LV/KV, LK Mixed Ratio 1 = LL/KV, and LK Mixed Ratio 2 = LV/KL.
Simpson teaches a ratio of lactate and ketone (see paragraph 0426).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayter with the teachings of Simpson because it would have resulted in the predictable result of providing an output of a numerical value relating to analytes being measured to a more significant output that is to give a user a level of insight to actionable outputs informing a user of specific steps to take utilizing a ratio of analyte values (Simpson: [0426]).
With respect to claim 15, all limitations of claim 14 apply in which Hayter further discloses wherein the indicator ratio is a GK Ratio of the glucose data and the ketone data (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times).
Hayter does not specifically disclose the GK Ratio being chosen from: GK Ratio 1 = GL/KL, GK ratio 2 = GV/KV, GK Mixed Ratio 1 = GL/KV, and GK Mixed Ratio 2 = GV/KL.
Simpson teaches a ratio of glucose and ketone (see paragraph 0426).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayter with the teachings of Simpson because it would have resulted in the predictable result of providing an output of a numerical value relating to analytes being measured to a more significant output that is to give a user a level of insight to actionable outputs informing a user of specific steps to take utilizing a ratio of analyte values (Simpson: [0426]).
With respect to claim 16, all limitations of claim 14 apply in which Hayter further discloses wherein the indicator ratio is a LG Ratio of the lactate data and the glucose data (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times).
Hayter does not specifically disclose the LG Ratio being chosen from: LG Ratio 1 = GL/LL, LG Ratio 2 = GV/LV, LG Mixed Ratio 1 = GL/LV, and LG Mixed Ratio 2 = GV/LL.
Simpson teaches a ratio of lactate and glucose (see paragraph 0426).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayter with the teachings of Simpson because it would have resulted in the predictable result of providing an output of a numerical value relating to analytes being measured to a more significant output that is to give a user a level of insight to actionable outputs informing a user of specific steps to take utilizing a ratio of analyte values (Simpson: [0426]).
With respect to claim 17, all limitations of claim 14 apply in which Hayter further discloses wherein the indicator ratio is an LK Ratio of the lactate data and the ketone data (see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times).
Hayter does not specifically disclose the LK Ratio being chosen from: LK Ratio 1 = LL/KL, LK Ratio 2 = LV/KV, LK Mixed Ratio 1 = LL/KV, and LK Mixed Ratio 2 = LV/KL.
Simpson teaches a ratio of lactate and ketone (see paragraph 0426).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayter with the teachings of Simpson because it would have resulted in the predictable result of providing an output of a numerical value relating to analytes being measured to a more significant output that is to give a user a level of insight to actionable outputs informing a user of specific steps to take utilizing a ratio of analyte values (Simpson: [0426]).
Claims 6-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter in view of Ward (US 20080125636 A1; cited by applicant).
With respect to claim 6, all limitations of claim 2 apply in which Hayter further discloses the global metric comprises a ketone global metric chosen from: Global Metric K1 = A*KV + B*KL (see paragraph 0136, the glycemic impact is determined quantitatively in terms of the glucose level, mean glucose level, a maximum peak of glucose after meals and any combination thereof which means that they can be added together; and see paragraph 0138, the sum of glucose values can be calculated and each metric can be used to rank and/or sort the glycemic response to meal; and see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times; and see Fig. 3A #314 and #316; and see paragraph 0136, glycemic impact is determined quantitatively in terms of the median and mean glucose level; the instant applicant states in paragraph 0038 that the glucose load is the mean glucose level; and see paragraph 0136, glycemic impact is determined quantitatively in terms of a maximum peak of glucose; and see paragraph 0137, meal glucose peaks), Global Metric K2 = (A*KV)/(B*KL), Global Metric K3 = (A*KL)/(B*KV), and Global Metric K4 = {(A*KL)/(KROC)}*Ketone Ratio; wherein the KROC is a ketone rate of change, the Ketone Ratio is a running ketone value divided by an average daily ketone level, and A and B are weighting factors.
Hayter does not disclose wherein A and B are weighting factors.
Ward teaches weighting factors (see paragraph 0024, metrics to evaluate an individual’s glucose level control may be weighted differently as desired).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayter with the weighting factors taught by Ward because it would have resulted in the predictable result of weighting recent glucose values more heavily than a more distant glucose value (Ward: see paragraph 0046) when determining a metric.
With respect to claim 7, all limitations of claim 2 apply in which Hayter further discloses the global metric comprises a lactate global metric chosen from: Global Metric L1 = A*LV + B*LL (see paragraph 0136, the glycemic impact is determined quantitatively in terms of the glucose level, mean glucose level, a maximum peak of glucose after meals and any combination thereof which means that they can be added together; and see paragraph 0138, the sum of glucose values can be calculated and each metric can be used to rank and/or sort the glycemic response to meal; and see paragraph 0136, the glycemic implant of the meal event is determined quantitatively and further does with reference to analyte data where [0205] teaches the analyte may be glucose, ketone or lactate monitored at the same or different times; and see Fig. 3A #314 and #316; and see paragraph 0136, glycemic impact is determined quantitatively in terms of the median and mean glucose level; the instant applicant states in paragraph 0038 that the glucose load is the mean glucose level; and see paragraph 0136, glycemic impact is determined quantitatively in terms of a maximum peak of glucose; and see paragraph 0137, meal glucose peaks), Global Metric L2 = (A*LV)/(B*LL), Global Metric L3 = (A*LL)/(B*LV), and Global Metric L4 = {(A*LL)/(LROC)}*Lactate Ratio; wherein the LROC is a lactate rate of change, the Lactate Ratio is a running lactate value divided by an average daily lactate level, and A and B are weighting factors.
Hayter does not disclose wherein A and B are weighting factors.
Ward teaches weighting factors (see paragraph 0024, metrics to evaluate an individual’s glucose level control may be weighted differently as desired).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayter with the weighting factors taught by Ward because it would have resulted in the predictable result of weighting recent glucose values more heavily than a more distant glucose value (Ward: see paragraph 0046) when determining a metric.
With respect to claim 9, all limitations of claim 8 apply in which Hayter further discloses wherein the global metric comprises a global mixed metric chosen from: Global Mixed Metric 1 =A*GV+B*KV +C*GL + D*PPP (see paragraph 0136, the glycemic impact is determined quantitatively in terms of the glucose level, mean glucose level, a maximum peak of glucose after meals and any combination thereof which means that they can be added together; and see paragraph 0138, the sum of glucose values can be calculated and each metric can be used to rank and/or sort the glycemic response to meals; and see 0205, the analyte may be glucose, ketone or lactate monitored at the same or different times), Global Mixed Metric 2 = A*GV+B*KV +C*KL + D*PPP, Global Mixed Metric 3 = A*GL/KL, Global Mixed Metric 4 = A*GV/KV, Global Mixed Metric 5 = A*GROC/KROC, and Global Mixed Metric 6 = A*GL/KL + B*GV/KV + C*GROC; wherein A, B and C are weighting factors.
Hayter does not disclose wherein A and B are weighting factors.
Ward teaches weighting factors (see paragraph 0024, metrics to evaluate an individual’s glucose level control may be weighted differently as desired).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hayter with the weighting factors taught by Ward because it would have resulted in the predictable result of weighting recent glucose values more heavily than a more distant glucose value (Ward: see paragraph 0046) when determining a metric.
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791