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 § 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 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent (see MPEP 2106). A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation "non-transitory" to the claim.
Claims 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding Step 1, claims 1-20 are all within at least one of the four categories.
Regarding Step 2A (prong 1), the independent claims (1,17, and 20) recites:
generate a pattern based on a rate of change associated with the one or more current
measurements received from the sensor and the one or more past measurements stored in the memory circuit; determine a first alignment with a first user target based on the generated pattern, wherein the first user target relates to one or more of a mental state or physical state of the user.
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 m., 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 generating and determining 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.
The idea of generating a pattern based on analyte measurements and determining alignment of data could be performed by simply looking at the acquired data values.
Regarding Step 2A (prong 2):
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 storing and uploading merely invoke a computer as a tool.
The data-gathering step (receiving) and the data-output step (outputting) do 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 and outputting,
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 a medical measurement.
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 receiving, generating, determining, and outputting. The claims do not apply the obtained response measurement to a particular machine. Rather, the data is merely output in a post-solution step.
Regarding Step 2B:
The additional elements are identified as follows: sensors and a processor. 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 Information in the Specification
Applicant's specification (Pg. 49, Paragraph 0194) which discloses that the processor and memory comprise generic computer components that are configured to perform the generic computer functions (receiving and outputting) that are well-understood, routine, and conventional activities previously known to the pertinent industry; and
the non-patent literature cited herewith ("Feasibility of an implanted, closed-loop, blood-glucose control device" by Fletcher, 2001), which discloses the "glucose sensor to complete the artificial pancreas, investigators have prepared control algorithms with which to operate the required feedback loop. The systems do not require much computing power relative to that presently available. A 1993 study used an Intel processor at 5 MHz, compared with the 200-MHz processors now carried by most electronics stores." (Pg. 15);
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)(II) 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.
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.
Claims 2, 5, 10, and 11 are steps that are additional data output that is well understood, routine and conventional (WURC) through receiving patient data.
Claims 3-4, 6-7, 12-14, 16, and 19 ate steps that are additional data output that is WURC through outputting a recommendation/result.
Claims 8 and 18 are steps that are also abstract through refining a pattern based on additional measurements is a mental process that can be performed by simply looking at the analyte data.
Claim 9 is steps that are also abstract through using a correlating measurement with a mental state is a mental process that can be performed by simply looking at the analyte data and mental state data.
Claim 15 is steps that are also abstract through predicting a future patient state is a mental process that can be performed by looking at analyte data
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.
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.
Claim(s) 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Ahmad (US 20170332951 A1, cited by applicant) in view of Cole (US 20180256103-Cited by the Applicant).
Ahmad teaches a system/computer-implemented method/non- transitory computer readable medium (Paragraph 0313) comprising: a sensor configured to generate one or more current levels of an analyte for a user, wherein the one or more current levels of the analyte are correlated to a current level of ketones of the user (Paragraph 0277: "FIG. 33 depicts a system wherein the ketone sensor 212 is coupled to a mobile device 230. The mobile device prompts the user to perform a glucose reading on the glucose sensor 3300. The processor on the mobile device 230 is configured to compare the ketone levels with the glucose levels");
a memory circuit storing one or more past measurements of one or more past levels of the analyte for the user, wherein the one or more past levels of the analyte are correlated to one or more past levels of ketones of the user (Paragraph 0172: "actual ketone measurement results can be compared to identify or evaluate changes (e.g., over time)", Paragraph 0230: "data identifying one or more trigger points and associated ketone states may be stored in memory of an electronic device or in the remote system", and Paragraph 0281); and a processor in data communication with the sensor and the memory circuit (Paragraph 0281: "a connected mobile device receiving information from the sensor 212"), the processor configured to: receive, from the sensor, the one or more current measurements (Paragraph 0232:"The processing of the ketone measurement results and the ketone state may comprise comparing the acetone or ketone measurement results against the ketone state. For example, the values of the acetone or ketone measurement results may be compared with the pattern identified by the ketone state to see if the values match or closely match the pattern (e.g., within a threshold value). If there is a match or a substantially close match (e.g., a match within a threshold value or percentage), the measurement device or the electronic device may determine that the trigger point occurred"); generate a pattern based on a rate of change (Paragraph 0251: percent change in values is rate of change associated with the one or more current measurements received from the sensor and the one or more past measurements stored in the memory circuit (Paragraph 0232 and Paragraph 0251-0252: use of patterns and how they can be updated); determine a first alignment with a first user target based on the generated pattern, wherein the first user target relates to one or more of a mental state or physical state of the user (Paragraph 0235: "Once the system has logged a threshold number of occurrences (e.g., 3, 4 or 5) of a given trigger point (e.g., "eat chocolate") together with associated ketone measurements, the system may use an appropriate correlation algorithm to determine whether a statistically significant correlation exists. This analysis may, for example, reveal that the participant's acetone level drops by 15% to 25% when the trigger point occurs" and Paragraph 0237); and output a first result to the user, based on the determined first alignment (Paragraph 0236-0238: results outputted to user to allow confirmation, change, or option to ignore).
Ahmad fails to explicitly teach a sensor configured to generate, on at least a defined interval and without user intervention, one or more current measurements associated with one or more current analyte levels of an analyte for a user.
Cole teaches a sensor configured to generate, on at least a defined interval and without user intervention, one or more current measurements associated with one or more current analyte levels of an analyte for a user (Paragraph 0026: "Continuous Analyte Monitoring" systems (e.g., "Continuous Glucose Monitoring" systems), for example, can transmit data from a sensor control device to a reader device continuously or repeatedly with or without prompting, e.g., automatically according to a schedule"). It would be obvious to one of ordinary skill in the art before the effective filing date of the
claimed invention to modify the sensor of Ahmad to incorporate the sensor configured to operate on a defined interval without user intervention taught by Cole, because it ensures that analyte value would automatically be provided on a predetermined schedule (Paragraph 0026 of Cole). Ahmad teaches wherein the one or more current levels comprise one or more of a glucose level, a lactate level, or a ketone level (Paragraph 0276-0278). Ahmad teaches wherein the first result comprises a recommendation of an action (Paragraph 0268-0269 and 0280: therapy modification and other actions can be recommended). Ahmad teaches wherein the recommendation of the action comprises one or more of a recommendation to refrain from eating one or more foods, a recommendation to eat one or more foods, a recommendation to partake in one or more activities, or a recommendation to refrain from one or more activities (Paragraph 0268-0269 and 0280). Ahmad teaches wherein the processor is configured to output the first result in a user interface indicating one or more of a current ketone state of the user or a predicted future ketone state of the user (Paragraph 0232: "The processing of the ketone measurement results and the ketone state may comprise comparing the acetone or ketone measurement results against the ketone state. For example, the values of the acetone or ketone measurement results may be compared with the pattern identified by the ketone state to see if the values match or closely match the pattern (e.g., within a threshold value). If there is a match or a substantially close match (e.g., a match within a threshold value or percentage), the measurement device or the electronic device may determine that the trigger point occurred"). Ahmad teaches wherein the processor is configured to output the first result in a user interface indicating one or more of a current weight of the user or a predicted future weight of the user (Paragraph 0175 and Paragraph 0291: weight loss program is an option). Ahmad teaches wherein the processor is configured to output the first result in a user interface indicating one or more of a current mental state of the user or a predicted future mental state of the user (Paragraph 0263-0264 and Paragraph 0220: stress is an output). Ahmad teaches wherein the processor is further configured to: refine the pattern based on the one or more current measurements (Paragraph 0252: "the pattern recognition time period is an indefinite period of time because the App may continue to determine new patterns or update existing, recognized patterns as breath acetone measurements are taken"); receive one or more additional measurements of one or more additional levels of the analyte for the user (Paragraph 0251-0253: constantly updating patterns with new measurements for new results); and determine a second alignment with the first user target based on the refined pattern (Paragraph 0251-0253: constantly updating patterns with new measurements for new results). Ahmad teaches wherein the one or more past measurements are correlated with one or more past mental states, wherein the first user target relates to the mental state, and wherein the first result comprises a predicted mental state of the user (Paragraph 0263-0264, Paragraph 0220, and Paragraph 0212: stress is an output). Ahmad teaches wherein the processor is further configured to: receive an indication of a physical activity associated with the user (Paragraph 0286-0287: various physical activity measurements taken); and generate the pattern further based on the indication of the physical activity (Paragraph 0284-0287). Ahmad teaches wherein the first user target relates to a ketone level (Paragraph 0273-0277). Ahmad teaches wherein the first result indicates whether or not the first user target is predicted to be met at a future time (Paragraph 0279-0280). Ahmad teaches wherein, to generate the pattern, the processor is configured to: determine the rate of change, based on the one or more current measurements and the one or more past measurements; generate a trend line for the user, based on the determined rate of change (Paragraph 0251: "As another example, the pattern may be determined based on a comparison of the change in values of breath acetone levels each time the user-specific trigger point occurs (if the user-specific trigger point occurs multiple times). If the change in values before and after the occurrence of a trigger point is a decrease of 10% (e.g., the first time the trigger point occurs), 12% (e.g., the second time the trigger point occurs), and 14% (e.g., the third time the trigger point occurs), for example, a combination of these values may be taken to determine the pattern (e.g., a mean of the percent changes could be taken such that the trigger point is identified in subsequent breath acetone measurements when a breath acetone level drops 12%, a range of the percent changes could be taken such that the trigger point is identified in subsequent breath acetone measurements when a breath acetone level drops between 10%-14%, etc.)"); and estimate a future state of the user, based on the trend line (Paragraph 0251-0253 and Paragraph 0263-0264). Ahmad teaches wherein the processor is further configured to: identify a plurality of user targets associated with the user, wherein the plurality of user targets comprise user-specified targets with respect to (i) weight loss (Paragraph 0174-0175), (ii) mental health (Paragraph 0263-0264, Paragraph 0220, and Paragraph 0212: stress is an output), (iii) glucose level (Paragraph 0276-0284), (iv) insulin sensitivity (Paragraph 0271-0272), and (v) glucose sensitivity (Paragraph 0276- 0284). Ahmad teaches wherein, to determine the first alignment with the first user target, the processor is configured to: determine whether a current state of the user aligns with the first user target; and determine whether a predicted future state of the user aligns with the first user target (Paragraph 0266-0269: uses pattern and trigger points to determine if a treatment needs to be changed based on alarm thresholds).
Regarding claim 16, Ahmad teaches wherein the processor is further configured to: in response to determining that the predicted future state of the user does not align with the first user target, generate a first recommendation, wherein the first recommendation includes an action that will increase a probability that the predicted future state will align with the first user target, and wherein the first result comprises the first recommendation (Paragraph 0266-0269: uses pattern and trigger points to determine if a treatment needs to be changed based on alarm thresholds, and give recommendation for changing treatment).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-40 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,048,533. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader than those of the Patent. As, such, any invention meeting the limitations of the claims of the Patent would necessarily meet those of the instant application as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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