DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
The preliminary amendment to the claims filed 30 October 2024 has been entered. Claim(s) 1-9 has/have been canceled. New claim(s) 10-39 has/have been added and is/are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation ("BRI") using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The BRI of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked.
As explained in MPEP § 2181(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
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) 13, 16-17, 20, 25, 28, 30-31, 33 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 13, claim 25 and claims dependent thereon, the limitation "determining, based at least in part on at least one or more of the first data and/or the second data, that there is an increased risk of hypoglycemia" of claim 13 and the comparable limitation of claim 25 is indefinite. "Increased risk" is a relative term. It is unclear on what basis (i.e., relative to what) a determination that risk is "increased" is based.
Regarding claims 16-17, claims 30-31 and claims dependent thereon, the limitations "at least one or more of the first data and/ or the second data includes a representation of a behavioral pattern" and "at least one or more of the first data and/ or the second data includes a representation of a metabolic state" of claims 16-17, and the comparable limitations of claims 30-31 are indefinite.
Applicant discloses, "The one or more observer modules may include a short term observer module. The short term observer module may contain information relating to: metabolic state; meal excursion; and/or metabolic state and meal excursion. The short term observer module observes X times per hour, where X is 0<X<7200. It should be appreciated that the frequency may be greater or less as desired or required. The short term observer module may be configured to output one of the following: a vector of estimates of key metabolic states of an individual; a single, processed glucose sample at a specific time, or a history of glucose samples up to a specific time, or a statistic computed from glucose samples up to a specific time; or both the vector of estimates of key metabolic states and the sample or history of processed glucose samples. The vector of estimates may include plasma glucose and plasma insulin. The one or more observer modules may include a long term observer module. The long term observer module may contain information relating to behavioral profiles. The behavioral profiles may be daily behavioral profiles, but may vary as desired or required. The long term observer module may assess behavioral profiles X times per month, where X is 0<X<60. It should be appreciated that the frequency may be greater or less as desired or required. The long term observer module may be configured to output one or more of the following types of information: a daily profile of an individual's meal behavior as a function of the time of day; a daily profile of the individual's exercise behavior as a function of the time of day; and a daily profile of the individual's utilization of insulin as a function of the time of day" (¶¶ [0315]-[0316] as published). Applicant does not appear to disclose any one profile output by the long-term observer module is assessed using glucose samples over different/longer period of time than any other profile output by the long-term observer module.
In view of the above, to the best of the examiner's understanding, "the first data…based on an observation of glucose samples over a first period of time" and "the second data…based on an observation of glucose samples over a second period of time longer than the first period of time" refer to the data output by a short-term observer(s) and output by a long-term observer(s), respectfully. In view of this understanding, Applicant appears to disclose the first data represents a metabolic state of the patient including at least one of "a vector of estimates of key metabolic states of an individual; a single, processed glucose sample at a specific time, or a history of glucose samples up to a specific time, or a statistic computed from glucose samples up to a specific time; or both the vector of estimates of key metabolic states and the sample or history of processed glucose samples;" and the second data represents a behavioral pattern of the patient including at least one of "a daily profile of an individual's meal behavior as a function of the time of day; a daily profile of the individual's exercise behavior as a function of the time of day; and a daily profile of the individual's utilization of insulin as a function of the time of day." Accordingly, it is unclear what "representation of a behavioral pattern of the patient" may be included in the "first data" (as required/encompassed by claims 16 and 30) and what "representation of a metabolic state of the patient" may be included in the "second data" (as required/encompassed by claims 17 and 31).
Regarding claim 20, claim 33 and claims dependent thereon, the limitation "assessing the profile at least monthly" of claim 20, and the comparable limitation of claim 33 are indefinite. It is unclear what is required by "assessing" the profile descriptive of the patient's statistical insulin utilization, particularly as there is no indication in the claim that the profile is produced by the method or system as claimed. Rather, the pending claims appear to only require the profile to be "received" as the first data and/or second data. Does "assessing the profile" indicate that the method/system as claimed is generating/estimating said profile at least monthly, or is some different "assessment" of an externally-generated profile that is received by the method/system being performed monthly? If the latter, it is further unclear what said assessment requires and how, if at all, said assessment factors into determining an insulin infusion.
Regarding claim 28 and claims dependent thereon, the scope of "in combination with" is indefinite. It is unclear if the system of claim 23 "in combination with an insulin injector" is meant to limit the system to including the insulin injector as recited, or to indicate, e.g., an intended or suitable use of the system.
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) 16-17, 30-31 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 claims 16-17, claims 30-31 and claims dependent thereon, as noted with respect to rejections under 35 U.S.C. 112(b) above, the limitations of claims 16-17 and 30-31 indefinite. It is unclear to what "representation of a behavioral pattern of the patient" and "representation of a metabolic state of the patient" refer based on the different time periods of observations associated with first and second data as required by the respective independent claims. Additionally, Applicant fails to sufficiently disclose an algorithm commensurate in scope with these limitations. Particularly, Applicant does not disclose any "representation of a behavioral pattern of the patient," or algorithm for calculating such a representation, that is based on a shorter period of glucose sample observations than the claimed second data related to the glycemic state of the user. Similarly, Applicant does not disclose any "representation of a metabolic state of the patient," or algorithm for calculating such a representation, that is based on a longer period of glucose sample observations than the claimed first data related to the glycemic state of the user. Further, the limitations of claims 16-17 and 30-31 appear to encompasses each of the first data and second data including the same "representation," just calculated based on glucose sample observations over different lengths of time. No such arrangement/algorithm is sufficiently disclosed in the application as filed. Rather, as noted above with respect to rejections under 35 U.S.C. 112(b), Applicant discloses each of the short-term and long-term observer modules, each output different "representations." Specifically, the short-term observer module is disclosed as outputting a representation of metabolic state based on an observation of, inter alia, glucose samples during a shorter time period; and the long-term observer module is disclosed as outputting a representation of a behavioral pattern(s) based on observation of, inter alia, glucose samples during a longer period of time. Therefore, the full scope of claims 16-17 and 30-31 is not adequately disclosed.
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) 10-13, 16-25 and 27-38 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claims 10-13, 16-25 and 27-38 recite the steps of determining an insulin infusion based on the first data, the second data, the glucose input, and the first insulin delivery command; determining an allowed insulin infusion, for example, based on a safety evaluation of the determined insulin infusion by determining a risk of at least one of hypoglycemia or hyper-glycemia, or an increased risk of hypoglycemia, based on the first data and/or the second data; and assessing a profile of the first and/or second data monthly. These limitations, as drafted, are a process that, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting the steps are performed by control system, or processor thereof, nothing in the claim elements preclude the step from practically being performed in the mind. For example, but for the control system/processor language, the above-noted claim limitations encompass a user mentally or manually judging his/her current metabolic state based on current and/or historical glucose measurements and administered insulin; and considering his/her typical pattern of behaviors (e.g., times of meals, content of meals, exercise habits, etc.) to estimate how much insulin to administer while taking into account if he/she is at risk (or increased risk) of hypoglycemia (e.g., near or trending low) in making said judgement. This is comparable to the decision process in conventional self-monitoring and/or diabetes management performed regularly by diabetic individuals (see, e.g., Magni '187, pg. 3, line 28 - pg. 4, line 14). Additionally, the step of assessing a profile of the first and/or second data monthly presumably encompasses assessing whether his/her behavior(s), such as statistical insulin utilization, have changed from one month to the next. If claim limitations, under their BRI, cover performance of the limitation in the mind but for the recitation of generic computer components, then they fall within the "mental processes" grouping of abstract ideas. Accordingly, claims 10-13, 16-25 and 27-38 recite an abstract idea.
This judicial exception is not integrated into a practical application. The claims recite the additional element of using a generic computer component (e.g., control system or processor thereof), or a generic personal device having said generic computer component, to perform the above-noted steps; generic steps in which the data necessary for performing the abstract idea is received by the generic computer component/device; a generic step in which the result of performing the abstract idea is output, or transmitted; and an indication that the system is usable with an insulin injector operable to inject insulin. The computer component/device is recited at a high-level of generality (i.e., as a generic processor or personal device performing a generic computer function of analyzing received information). The inclusion of the generic computer component and the generic receiving and transmitting steps do no more than merely invoke a computer component/device as a tool, such that the additional elements recited in the claim, either alone or in combination, amount to no more than mere instructions to apply the exception using a generic computer component. Further, the limitations of claim 28 only appear to require that the claimed system is/may be used with an insulin injector capable of injecting insulin based on the determined allowed insulin. There is no indication that the system in any way communicates with and/or controls the insulin injector to deliver the allowed insulin. Rather, the claim appears to encompass a manual insulin injector that a user may use to determine the allowed insulin amount. In view of the above, the limitations of claim 28 appear, at best, to generally link the use of a judicial exception to a field of use, with no indication that any treatment is actually being delivered by any component of the system. Accordingly, the additional elements of the claims 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 10-13, 16-25 and 27-38 are directed to an abstract idea.
The 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 element of using a generic computer component to perform the abstract idea amounts to no more than mere instructions to apply the exception using a generic computer component. Additionally, the courts have recognized generically receiving and transmitting data over a network, as is recited in/encompassed by the additional elements of the pending claims, as insignificant extra-solution activity and/or a well‐understood, routine, and conventional computer function (see MPEP 2106.05(d)(II)). Lastly, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself (see MPEP 2106.05(h)). Mere instructions to apply an exception using a generic computer component; adding insignificant extra-solution activity to the judicial exception; generally linking the use of the judicial exception to a particular technological environment or field of use; and/or simply appending well-understood, routine, conventional activities previously known to the industry and specified at a high level of generality to the judicial exception cannot provide an inventive concept (MPEP 2106.05(I)(A)). Therefore claims 10-13, 16-25 and 27-38 are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 10-11, 14-23, 26-37 and 39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2009/059187 A1 (Magni '187) in view of US 2010/0145262 A1 (Bengtsson).
Regarding claims 10-11, 22-23 and 36-37, Magni '187 discloses and/or suggests a system for diabetes control, the system comprising:
at least one processor and at least one non-transitory computer-readable medium or memory having control/computer program logic stored thereon that is executable by the at least one processor (e.g., pg. 7, lines 4-12; Figs. 1-4, 8-10, etc.) to perform a method of (or operations for) adaptive diabetes control, the method/operations comprising, by the diabetes control system:
receiving a glucose input reflective of glucose sample processing by a continuous glucose monitor (CGM) sensor (pg. 2, lines 16-23, previous glucose samples; pg. 17, lines 16-23, the filtered value of the glucose concentration obtained from the CGM, Gmed (k); etc.);
receiving a first insulin delivery command, the first insulin delivery command representing a most recent command to an insulin injector of the patient relative to a time of the glucose input (pg. 2, lines 16-23, previous values of the external insulin infusion; pg. 17, lines 16-23, nominal insulin rate, unom (k); etc.);
receiving first data related to a glycemic state of a user, wherein the first data is based on an observation of glucose samples over a first period of time (pg. 17, line 23 - pg. 18, line 2, state vector x(k); claim 15, state vector; etc.);
receiving second data related to the glycemic state of the user based on an observation of data over a second period of time longer than the first period of time (pg. 17, line 23 - pg. 18, line 2, vector of future glucose disturbances inferred from patient behavioral data collected during a screening visit; claim 15, future glucose disturbances; etc.);
determining an insulin infusion based at least in part on the first data, the second data, the glucose input, and the first insulin delivery command (pg. 17, line 23 - pg. 18, line 2, given the state vector and future glucose disturbances, a nominal insulin rate, unom (k), is computed; claim 15; etc.); and
determining an allowed insulin infusion based at least in part on a safety evaluation of the determined insulin infusion (pg. 18, line 13, safety limits are applied to modify unom (k)).
Magni '187 does not expressly disclose the second data is based at least in part on an observation of glucose samples over a second period of time longer than the first period of time. Specifically, Magni '187 discloses the second data is inferred from "patient behavioral data β" obtained during a screening visit (pg. 17), but does not expressly disclose what said behavioral data is/includes.
Bengtsson discloses/suggests determining second data related to the glycemic state of a user based on an observation of glucose samples over a relatively long period of time (e.g., ¶ [0014] days, weeks, etc.) (Abstract, calculating an estimated event forecast based on logged historical data such as drug delivered and corresponding physiological parameters such as blood glucose level; ¶ [0014]; etc.). Accordingly, Bengtsson discloses/suggests second data related to the glycemic state of the user, such as representation of a behavioral pattern of the user (e.g., future disturbances, events, etc.), may be determined based an observation of glucose samples over the second period.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method/operations of Magni '187 with the second data being based on an observation of glucose samples over a second period of time longer than the first period of time (e.g., being inferred from logged historical data including blood glucose level) as taught/suggested by Bengtsson in order to facilitate inferring/forecasting future glucose disturbances (e.g., meals, exercise, etc.) to compute optimal insulin injection to safely regulate glucose concentration (Magni '187, pg. 2, lines 17-23; Bengtsson, Abstract; etc.).
Regarding claims 14-15, 26-27 and 39, Magni '187 as modified discloses and/or suggests the system comprises an interface for one or more of wired and/or wireless communication (Figs. 1-4), and the method/operations further comprise(s) transmitting an insulin injector command signal via the interface through at least one or more of a wired communication channel and/or a wireless communications channel; and delivering the allowed insulin injection (e.g., Figs. 1-4, controller 12 communicates with insulin pump 14 through a wired/wireless connection, leading insulin pump 14 to deliver insulin 22 to the body; pg. 18, pump command; etc.).
Regarding claims 16 and 30, Magni '187 as modified discloses and/or suggests the second data includes a representation of a behavioral pattern of the patient (e.g., Magni '187, pg. 17, lines 28-30, vector of future glucose disturbances is inferred from past patient behavioral data; Bengtsson, ¶ [0014]; etc.).
Regarding claims 17 and 31, Magni '187 as modified discloses and/or suggests the first data includes a representation of a metabolic state of the patient (pg. 17, line 23 - pg. 18, line 2, state vector x(k); claim 15, state vector; etc.).
Regarding claims 18 and 32, Magni '187 as modified discloses and/or suggests the first data includes first observational data related to a metabolic state for a time that is within, spans, or overlaps with the first period of time (e.g., pg. 17, lines 16-25, the state vector and/or observed data related to the metabolic state thereof, e.g., glucose concentration, differential glucose, etc.); and the second data includes second observational data related to a behavioral pattern for a time that is within, spans, or overlaps with the second period of time (e.g., Magni '187, pg. 17, lines 28-30, vector of future glucose disturbances is inferred from past patient behavioral data; Bengtsson, ¶ [0014]; etc.).
Regarding claims 19-20 and 33-34, Magni '187 as modified discloses and/or suggests at least one of the first data or the second data includes a profile descriptive of the patient's statistical insulin utilization (pg. 17, lines 1-25, state vector is based on/includes basal insulin, ub (k), i.e., the patient's time-varying basal insulin rate).
Alternatively/Additionally, particularly with respect to claims 20 and 34, Bengtsson discloses and/or suggests determining second data related to the glycemic state of a user based on an observation of glucose samples over a relatively long period of time, said data including a profile descriptive of the patient's statistical insulin utilization (¶ [0137] average use of insulin from historical data, e.g., the last 'z' days), and discloses/suggests said profile can be updated at least monthly (¶ [0105] assessing changes in average insulin profile, e.g., over the last 'z' days; ¶ [0135] adaptive learning ensures algorithm settings are adjusted if user changes his/her habits; etc.). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method and/or operations of Magni '187 with the second data including a profile descriptive of the patient's statistical insulin utilization that is assessed at least monthly as taught and/or suggested by Bengtsson in order to ensure algorithm settings are adjusted if user changes his/her habits (Bengtsson, ¶ [0135]); enable providing additional safety filters/limits (Bengtsson, ¶ [0104]); etc.
Regarding claims 21 and 35, Magni '187 as modified discloses and/or suggests determining an insulin infusion includes computing the insulin infusion via at least a model predictive control (MPC) technique (throughout document, e.g., pg. 17, line 31 - pg. 18, line 10).
Regarding claim 28, Magni '187 as modified discloses and/or suggests the system, in combination with an insulin injector, wherein the insulin injector is operable to inject insulin based at least in part on the allowed insulin injection (e.g., Figs. 1-4, controller 12 communicates with insulin pump 14 through a wired/wireless connection, leading insulin pump 14 to deliver insulin 22 to the body; pg. 18, pump command; etc.).
Regarding claim 29, Magni '187 as modified discloses and/or suggests the system further comprises an interface for cellular communication (e.g., pg. 9, lines 28-30, communications may be implemented using a cellular phone link, an RF link, an infrared link, and other wireless communications channels).
Claim 12-13, 24-25 and 38 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Magni '187 in view of Bengtsson as applied to claim(s) 11, 23 and 37 above, and further in view of US 6,923,763 B1 (Kovatchev '763).
Regarding claims 12-13, 24-25 and 38, Magni '187 as modified discloses/suggests the limitations of claims 11, 23 and 37, as discussed above, but does not disclose determining the allowed insulin infusion includes: determining a risk of, or "increased" risk of, hypoglycemia based at least in part on at least one of the first data and the second data; and modifying, such as reducing, the insulin infusion based on the determined risk/determination of increased risk, the allowed insulin infusion including the modified insulin infusion.
Kovatchev '763 discloses and/or suggests a method comprising determining a risk, or increased risk, of hypoglycemia based on metabolic state data (e.g., blood glucose, insulin records) (Abstract, estimating BG in the near feature to estimate risk of the onset of hypoglycemia; col. 7, line 53 - col. 8, line 57); and modifying, e.g., reducing, an allowed insulin infusion based on/in response to the determined risk/increased risk (col. 5, lines 11-15; col. 5, lines 47-58; etc.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method/operations of Magni '187 with determining the allowed insulin infusion including determining a risk of, or "increased" risk of, hypoglycemia based at least in part on at least one of the first data or the second data; and modifying, such as reducing, insulin infusion based on the determined risk/determination of increased risk, the allowed insulin infusion including the modified insulin infusion as taught/suggested by Kovatchev '763 in order to provide an additional safety filter or limit for reducing complications of abnormal, e.g., hypoglycemic, glucose levels (Magni '187, pg. 18, line 13; Kovatchev '763, col. 4, lines 20-35; etc.).
Double Patenting
The nonstatutory double patenting ("NSDP") 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 NSDP 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 NSDP rejection 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 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 (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.
Claim (s) 10-39 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 10-18, 20-30 and 33-38 of copending Application No. 18/390,081 (reference application); or the reference application in view of Bengtsson.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim(s) 10-18, 20-30 and 33-38 of the reference application anticipate and/or encompass each limitation of claims 10-19, 21-33 and 35-39 of the present application.
Claims 18 and 30 of the reference application further recite/encompass each limitation of claims 20 and 34 of the present application, except for assessing the profile descriptive of statistical insulin utilization at least monthly. However, as discussed with respect to the prior art rejections above, Bengtsson discloses and/or suggests determining second data related to the glycemic state of a user based on an observation of glucose samples over a relatively long period of time, said data including a profile descriptive of the patient's statistical insulin utilization (¶ [0137] average use of insulin from historical data, e.g., the last 'z' days), and discloses/suggests said profile can be updated at least monthly (¶ [0105] assessing changes in average insulin profile, e.g., over the last 'z' days; ¶ [0135] adaptive learning ensures algorithm settings are adjusted if user changes his/her habits; etc.). It would have been obvious to modify claims 18 and 30 of the reference application with assessing the profile at least monthly as taught/suggested by Bengtsson in order to ensure algorithm settings are adjusted if user changes his/her habits (Bengtsson, ¶ [0135]); to enable providing additional safety filters/limits (Bengtsson, ¶ [0104]); etc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/Meredith Weare/Primary Examiner, Art Unit 3791
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