DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 October 2025 has been entered.
Status of Claims
Claim(s) 61-62, 70-71 and 78 is/are currently amended. Claim(s) 1-60, 67-68 and 76-77 has/have been canceled. Claim(s) 61-66, 69-75 and 78 is/are pending.
Rejections Withdrawn
Rejections under U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) and/or double patenting rejections not reproduced has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 61, 70 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 61, claim 70 and claims dependent thereon, the limitation(s) "determine if the merged single rate-of-change based episode has a first intermediate extreme point before the first start point and a second intermediate extreme point after the second end point; redefine the merged single rate-of-change based episode as extending between the first intermediate extreme point and the second intermediate extreme point if the single rate-of-change based episode is determined to include the first and second intermediate extreme points" of claim 61 and the comparable limitations of claim 70 are indefinite. Block 645 and the corresponding description thereof (e.g., ¶ [0092]) indicates the minimum and maximum (e.g., highest value and lowest value) of the merged episode are determined by scanning from the first point to the last point. One of ordinary skill in the art would readily appreciate a minimum or maximum occurring within the episode (and therefore not at the beginning or end of the episode, as an "intermediate" extreme value (i.e., between the start and end points). If such a value(s) is identified, block 645 indicates the episode is "redefined" by setting the intermediate extreme value(s) as the start or end point of the episode. However, the above-noted limitations of claims 61 and 70 require analyzing the single, merged episode for "intermediate extreme" points outside of the defined episode (i.e., before the first start point and after the second end point). Therefore, it is unclear to what the point(s) are "intermediate."
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 61, 70 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 61, claim 70 and claims dependent thereon, Applicant discloses, after episodes are merged/combined into a single, merged episode as claimed (Fig. 6, block 655), the merged episode can be scanned from the its first point to its last point to determine if a minimum and/or maximum exists between the first and last points (Fig. 6, block 645). Applicant does not disclose scanning for "intermediate extreme" points before the first or starting point of the single, merged episode or after the second or ending point of the single, merged episode. At best, Figure 6 (and the corresponding description thereof) appears to indicate scanning before a "first value" and/or after a "next value" may occur during defining of potential episodes (e.g., at block 640). Accordingly, the limitation(s) "determine if the merged single rate-of-change based episode has a first intermediate extreme point before the first start point and a second intermediate extreme point after the second end point; redefine the merged single rate-of-change based episode as extending between the first intermediate extreme point and the second intermediate extreme point if the single rate-of-change based episode is determined to include the first and second intermediate extreme points" of claim 61 and the comparable limitations of claim 70 lack support in the application as filed and are therefore directed to and/or encompass new matter.
The limitation "display, in real-time, the merged single rate-of-change based episode or the redefined merged single rate-of-change based episode" of claim 61 and the comparable limitation of claim 70 further lack support in the application as filed. Applicant discloses the system may comprise a display device on which a user interface (GUI) may be displayed (e.g., ¶ [0033]). The generated user-interface(s) "provide the user with the necessary tool to modify or create a treatment program for the patient" (e.g., ¶ [0034]). Applicant fails to disclose displaying any determined rate-of-change based episodes. Additionally, there is no indication in the application as filed that analyte measurement data to identify rate-of-change episodes is even analyzed in real-time, let alone displayed in real-time. Applicant appears to be relying on US 2004/0186365 ("Jin"), incorporated by reference in the present application, for support of the above-noted limitation (Remarks, pg. 6). However, Jin, at best discloses displaying glucose levels substantially in real time (e.g., ¶ [0009]). Jin does not disclose any episodes within received analyte measurement data are identified and then displayed in real-time as required by the present claims. Accordingly, the above-noted limitations are similarly directed to and/or encompass new matter.
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.
Claim(s) 61-66, 69-75 and 78 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 61-66, 69-75 and 78 recite the steps of identifying potential rate-of-change episodes extending between a start point and an end point and having a rate of change in analyte value over time above a threshold rate of change for a duration threshold; determining if the time between episodes is less than a time/distance threshold; merging episodes that are sufficiently close together in time; redefining merged episodes if a minimum and/or maximum value occurs before the start point of the merged episode and/or occurs after the end point of the merged episode; and comparing the redefined episode to the rate of change and duration thresholds.
These limitations, as drafted, are a process that, under their BRI, covers performance of the limitations in the mind but for the recitation of generic computer components. That is nothing in the claim elements preclude the steps from practically being performed in the mind. For example, identifying potential episodes can be mentally and/or manually performed by a user upon visual inspection of an analyte data (e.g., graph, trace, etc.), i.e., judging the start and end point of periods of rapidly changing analyte levels. Merging episodes encompasses the user deciding that adjacent periods/episodes should be combined if they are sufficiently close in time, i.e., within a threshold amount of time. Redefining a merged episode encompasses the user again mentally re-evaluating the episode to ensure the correct start and end points are assigned as the start and end points. Lastly, comparing the redefined episode encompasses the user mentally assessing whether the redefined episode still meets his/her rate-of-change episode criteria, such as a minimum rate of change and duration. If claim limitations, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer components (where present), then they fall within the "mental processes" grouping of abstract ideas. Accordingly, claims 61-78 recite an abstract idea.
This judicial exception is not integrated into a practical application. The claims recite the additional elements of establishing a communication link with a generic analyte monitoring device, such as a partially-implanted continuous glucose monitor; receiving analyte measurement data via the communication link, displaying identified episodes in real-time and storing the identified episodes in memory, limiting the type of analyte data to glucose or ketone body data, and, in the system claims, a generic input for said receiving and a generic computer component (processor(s)) configured to perform the steps of the abstract idea.
The steps of establishing a communication link with a generic analyte monitoring device, such as a CGM having a sensor at least partially implanted and receiving analyte measurement data via the communication link amount to mere data gathering necessary to perform the abstract idea, and is comparable to concepts identified by the courts as insignificant extra-solution activity (see MPEP 2106.05(g), performing clinical tests on individuals to obtain input for an equation, determining the level of a biomarker in blood, etc.). The steps of displaying identified episodes in real-time and storing identified episodes in memory amount to an insignificant application and/or necessary outputting of the results of performing the abstract idea, and is comparable to concepts identified by the courts as insignificant extra-solution activity (see MPEP 2106.05(g), printing or downloading generated menus, etc.). Limiting the abstract idea to glucose and/or ketone body data is comparable to limitations described by the courts as merely indicating a field of use or technological environment in which to apply a judicial exception (see MPEP 2106.05(h), example vi). The processor and input are recited at a high-level of generality (i.e., as a generic input for receiving data and a processor performing a generic computer function of comparing the received data to various thresholds), such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, claims 61-66, 69-75 and 78 are directed to an abstract idea.
The pending claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using an input and processor to perform receiving the analyte data and remaining steps of the abstract amounts to no more than mere instructions to apply the exception using a generic computer component. Additionally, the steps of establishing a communication link, receiving data over said link, and storing data analysis results are comparable to concepts recognized by the courts as well‐understood, routine, and conventional computer functions when they are claimed in a merely generic manner (e.g., at a high level of generality) (see, MPEP 2106.05(d)(II), receiving or transmitting data over a network, storing and retrieving information in memory, etc.). Further, there is sufficient evidence that receiving analyte measurement data of a sensor representing analyte measurement data collected continuously over a time period wherein the sensor is partially implanted and displaying the results of analyses of said data in real-time is well-understood, routine and/or conventional in the field. For example, Olczuk et al. ("A history of continuous glucose monitors (CGMs) in self-monitoring of diabetes mellitus") discloses CGMs having subcutaneous sensors and the ability to report real-time glucose values and trends were commercially available before the effective filing date of the present application (see pg. 184, wherein at least one CGM system from Medtronic, Dexcom, etc. were released/commercially available in 1999, 2006, etc.). Even when considered in combination, the limitations of the pending claims merely require the use of software to tailor analyte (e.g., glucose or ketone body) information to a user and provide it to said user and store it using a generic computer, similar to concepts identified by the courts as mere instructions to apply an exception. See MPEP 2106.05(f) (e.g., "Requiring the use of software to tailor information and provide it to the user on a generic computer"). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept; simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception; adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with an abstract idea so that the information can be analyzed by an abstract mental process; and/or generally linking the use of the judicial exception to a particular technological environment or field of use cannot provide an inventive concept. See MPEP 2106.05(A). Therefore, claims 61-66, 69-75 and 78 are not patent eligible.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant contends the steps of the pending claims cannot be practically performed in the mind (Remarks, pgs. 9-10).
The examiner first notes that several of the steps identified by Applicant as being incapable of being practically performed in the mind are not alleged to be mental processes. For example, though Applicant contends receiving analyte measurement data from a sensor that is partially implanted is not accessible or interpretable by a human without computational assistance (pg. 10), the step of receiving the analyte measurement data is not identified as a limitation reciting a mental process or abstract idea. Rather, as noted in the rejection above, the receiving step is identified as an additional element of the claim. However, the examiner respectfully disagrees that none of the steps of the claim can practically be performed in the mind. A user is able to observe collected analyte measurement data and observe "episodes" therein (e.g., significant rates of change within the data). This is supported by the cited prior art. For example, the previously-cited publication to Breton (US 2011/0264378 A1) discloses visual inspection of CGM data, i.e., a glucose trace, can be employed to see whether consecutive discrete events can be combined into single event, thereby suggesting that not only can a user identify the events from the trace, but also mentally/manually determine if said events should be combined into a single, merged event.
Applicant further submits the pending claims are integrated into a practical application because the claimed invention "improves the field of analyte monitoring and episode detection."
The examiner respectfully disagrees. Neither Applicant's remarks nor the specification as filed identifies how "rate-of-change analysis" "enhance[es] the accuracy and granularity of episode detection;" how "merging temporally adjacent episodes based on defined thresholds" "reduc[es] false positives/negatives," or how "refining episode boundaries using intermediate extreme points" "improv[es] downstream clinical decision-making." As noted in MPEP 2106.05(a), "If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification." Further, Applicant's alleged improvements appear to relate to the manner in which the episodes are identified and/or defined. These are the steps of the recited abstract idea. The judicial exception alone cannot provide the improvement. See MPEP 2106.05(a).
Lastly, Applicant contends the pending claims recite additional elements that amount to significantly more than the judicial exception (Remarks, pgs. 11-12).
The examiner respectfully disagrees. The only of the bullet points listed by Applicant (pg. 11) that are an "additional element" of the claims and not part of the judicial exception itself is the "storage of structured episode data in memory for further use." Storing the data for any/all future uses is a necessary data outputting (i.e., any "further use" of the analyte episode data requires this outputting) and is therefore insignificant extra-solution activity (MPEP 2106.05(g)). Furthermore, storing information in memory has been recognized by the courts as a well-understood, routine and/or conventional computer function (MPEP 2106.05(d)). As discussed in the rejection of record above, the limitations of the pending claims merely require the use of software to tailor analyte (e.g., glucose or ketone body) episode information to a user and store it using a generic computer, similar to concepts identified by the courts as mere instructions to apply an exception (see MPEP 2106.05(f), e.g., "Requiring the use of software to tailor information and provide it to the user on a generic computer"). In view of the above, the rejections under 35 U.S.C. 101 have been maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791