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 . 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.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 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 broadest reasonable interpretation 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, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “insulin delivery device” in claims 21, 29, 35, and 38-40 and “control device” in claims 35 and 38.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 25, 37, and 40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 25, 37, and 40, there is no support for “acceleration of the rate of change.” The disclosure contemplates acceleration (i.e., a second derivative) of the glucose value. Use of a third derivative is not contemplated.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 31 and 34 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, they depend on a condition which need not occur. Therefore, they are not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 21-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 21-34 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 21 recites (“sets forth” or “describes”) the abstract idea of a mental process and a mathematical concept, substantially as follows:
obtaining glucose concentration data measured in a bodily fluid of a host over a period of time, analyzing the glucose concentration data to determine a measure of glycemic urgency, wherein the measure of glycemic urgency is determined based at least in part on assessing a variability of the glucose concentration data, and comparing the measure of glycemic urgency to one or more thresholds of glycemic risk.
The obtaining, analyzing, and comparing steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. A person is able to obtain data by e.g. visually observing it, and they are able to analyze it and compare it to a threshold by reasoning through it. There is nothing to suggest an undue level of complexity in the steps. Therefore, a person would be able to perform them mentally or with pen and paper.
The steps also involve the mathematical concepts of data input, data processing, and comparison with thresholds. These steps correspond to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claim 21 does not include additional elements that integrate the mental process or mathematical concept into a practical application. Therefore, the claims are “directed to” the mental process and mathematical concept. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. a processor).
As a whole, the additional elements merely serve to generically implement the abstract idea on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and nothing needs to be done with the result of the comparison. This is at least because the “modifying” and “outputting” steps are conditional on the urgency exceeding a threshold, which condition need not actually occur. Therefore, in this method claim, the steps are not limiting.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 21 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. the type of data obtained (claims 22 and 23), types of variability that are part of the analyzing (claims 24-27), further details of the analyzing (claims 28 and 29), details regarding the thresholds (claims 30, 32, and 33), etc.).
Modifying insulin delivery as in claims 31-33 is not actually limiting, as already explained above. Generating an alert or alarm, as in claim 34, is also based on the condition that need not occur.
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21, 22, 24, 30-32, and 34-39 rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent Application Publication 2015/0273147 (“Duke”).
Regarding claim 21, Duke discloses [a] method for assessing and responding to glycemic risk, (Abstract), the method comprising: obtaining glucose concentration data measured in a bodily fluid of a host over a period of time (¶ 0035, glucose levels in interstitial fluid – also see the x-axis of Fig. 1); analyzing, by a processor (Fig. 2, computing device 66, which includes processor(s) 72 as shown in Fig. 3 – also see ¶ 0038), the glucose concentration data to determine a measure of glycemic urgency (Fig. 3, hazard analysis logic 80 – also see Fig. 10, steps 152-158, etc.), wherein the measure of glycemic urgency is determined based at least in part on assessing a variability of the glucose concentration data (¶ 0067, the glucose state from which risk is calculated is based on e.g. rate of change of glucose level); comparing, by the processor, the measure of glycemic urgency to one or more thresholds of glycemic risk (Figs. 6-9, ¶¶s 0067 and 0068, e.g. a positive or negative value); responsive to determining that the measure of glycemic urgency exceeds at least one threshold of glycemic risk of the one or more thresholds of glycemic risk (note that because this condition precedent need not actually occur, what follows is not limiting in a method claim. Nonetheless, for purposes of facilitating compact prosecution, the elements have been found), modifying insulin delivery by generating one or more modified insulin delivery commands (Fig. 10, step 162, adjusting the basal rate – also see e.g. ¶¶s 0069, 0080, etc., basal shutoff); and outputting the one or more modified insulin delivery commands for use by an insulin delivery device (Fig. 10, block 168).
Regarding claim 22, Duke discloses all the features with respect to claim 21, as outlined above. Duke further discloses wherein the glucose concentration data comprises continuous glucose sensing data measured by a continuous glucose sensor (Figs. 2 and 3, continuous glucose monitoring (CGM) system 50 includes a glucose sensor 56 – also see ¶ 0035).
Regarding claim 24, Duke discloses all the features with respect to claim 21, as outlined above. Duke further discloses wherein the variability of the glucose concentration data comprises a rate of change of the glucose concentration data (¶ 0067, the glucose state from which risk is calculated is based on e.g. rate of change of glucose level).
Regarding claim 30, Duke discloses all the features with respect to claim 21, as outlined above. Duke further discloses wherein the one or more thresholds of glycemic risk comprise: a physiological condition indicative of hypoglycemic risk, and/or a physiological condition indicative of hyperglycemic risk (Figs. 6-9, ¶¶s 0067 and 0068, e.g. a positive or negative value).
Regarding claim 31, Duke discloses all the features with respect to claim 21, as outlined above. Duke further discloses wherein modifying insulin delivery comprises reducing, suspending, or increasing insulin delivery (Fig. 10, step 162, adjusting the basal rate – also see ¶¶s 0069, 0080, etc., basal shutoff).
Regarding claim 32, Duke discloses all the features with respect to claim 21, as outlined above. Duke further discloses wherein: the at least one threshold of glycemic risk comprises a physiological condition indicative of hypoglycemic risk (Figs. 6-9, ¶¶s 0067 and 0068, e.g. a negative value); and modifying insulin delivery comprises reducing and/or suspending insulin delivery responsive to the measure of glycemic urgency exceeding the at least one threshold of glycemic risk comprising the physiological condition indicative of hypoglycemic risk (Fig. 10, step 162, adjusting the basal rate – also see ¶¶s 0069, 0080, etc., basal shutoff).
Regarding claim 34, Duke discloses all the features with respect to claim 21, as outlined above. Duke further discloses wherein the method further comprises generating an alert or an alarm responsive to determining that the measure of glycemic urgency exceeds the at least one threshold of glycemic risk (¶¶s 0041, 0050, 0080, 0082, etc., various types of alerts responsive to risk/urgency evaluations. In e.g. ¶ 0080, the generated notification/alert is based on the current hypoglycemic risk being greater than the hypoglycemic risk of a reference state).
Regarding claim 35, Duke discloses [a] system for assessing and responding to glycemic risk (Abstract), the system comprising: a control device (Fig. 2, computing device 66) configured to: obtain glucose concentration data over a period of time (¶ 0035, glucose levels in interstitial fluid – also see the x-axis of Fig. 1); analyze the glucose concentration data to determine a measure of glycemic urgency (Fig. 3, hazard analysis logic 80 – also see Fig. 10, steps 152-158, etc.), wherein the measure of glycemic urgency is determined based at least in part on assessing a variability of the glucose concentration data (¶ 0067, the glucose state from which risk is calculated is based on e.g. rate of change of glucose level); compare the measure of glycemic urgency to one or more thresholds of glycemic risk, wherein the one or more thresholds of glycemic risk comprise: physiological conditions indicative of hypoglycemic risk; and/or physiological conditions indicative of hyperglycemic risk (Figs. 6-9, ¶¶s 0067 and 0068, e.g. a positive or negative value); respond to a determination that the measure of glycemic urgency exceeds at least one threshold of the one or more thresholds of glycemic risk by modifying insulin delivery (Fig. 10, step 162, adjusting the basal rate); generate one or more modified insulin delivery commands based on the modified insulin delivery (e.g. ¶¶s 0069, 0080, etc., basal shutoff); and transmit the generated one or more modified insulin delivery commands to an insulin delivery device (Fig. 10, block 168).
Regarding claim 36, Duke discloses all the features with respect to claim 35, as outlined above. Duke further discloses wherein the period of time is less than one day (Figs. 5 and 13, e.g. a few hours).
Regarding claim 37, Duke discloses all the features with respect to claim 35, as outlined above. Duke further discloses wherein the variability of the glucose concentration data comprises: a rate of change of the glucose concentration data (¶ 0067, the glucose state from which risk is calculated is based on e.g. rate of change of glucose level); an acceleration of the rate of change of the glucose concentration data; a measure of deviation from one or more normal glucose patterns of a host; and/or a measure of one or more excursions from an expected glucose concentration of the host or a baseline glucose concentration of the host.
Regarding claim 38, Duke discloses all the features with respect to claim 35, as outlined above. Duke further discloses wherein the control device is configured to modify insulin delivery by: generating at least one insulin delivery command instructing the insulin delivery device to reduce or suspend insulin delivery when glycemic urgency exceeds the at least one threshold of the one or more thresholds of glycemic risk comprising physiological conditions indicative of hypoglycemic risk (¶¶s 0069, 0080, etc., basal shutoff); and/or generating at least one insulin delivery command instructing the insulin delivery device to increase insulin delivery when glycemic urgency exceeds the at least one threshold of the one or more thresholds of glycemic risk comprising physiological conditions indicative of hyperglycemic risk.
Regarding claim 39, Duke discloses all the features with respect to claim 35, as outlined above. Duke further discloses wherein the control device is one of a mobile device, a remote server, or an electronic circuit of the insulin delivery device (Fig. 2, computing device 66 is a mobile device and/or server – see ¶ 0038).
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.
Claims 29 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2015/0273147 (“Duke”).
Regarding claim 29, Duke teaches all the features with respect to claim 21, as outlined above. Duke further teaches wherein the measure of glycemic urgency is determined based on at least the glucose concentration data, the variability of the glucose concentration data (¶ 0067, based on the glucose measurement and its rate of change (variability)), and at least one indication of delivered insulin (Fig. 10, step 151 – the risk is based on state relative to a basal rate), but is not explicit that this indication is received from the insulin delivery device. However, Duke teaches that its insulin pump 84 communicates with the management device 66, including for providing current basal rate data (¶¶s 0036, 0037, 0040, 0066, 0074 (handling manual overrides), etc.). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to receive this data from the insulin delivery device, for the purpose of having current/actual data (¶¶s 0066, 0074, etc.).
Regarding claim 33, Duke teaches all the features with respect to claim 21, as outlined above. Duke further teaches wherein: the at least one threshold of glycemic risk comprises a physiological condition indicative of hyperglycemic risk (Figs. 6-9, ¶¶s 0067 and 0068, e.g. a positive value); and modifying insulin delivery comprises increasing insulin delivery responsive to the measure of glycemic urgency exceeding the at least one threshold of glycemic risk comprising the physiological condition indicative of hyperglycemic risk (¶ 0067, adjusting basal rate based on hyperglycemic risk – also see Fig. 10, blocks 176 and 166, which do not contemplate only decreasing the basal rate. Although increasing insulin delivery is not explicitly mentioned, the basal rate adjustment is meant to address hyperglycemic risk too, not just hypoglycemic risk. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to increase insulin delivery via the contemplated basal rate adjustment, for the purpose of addressing hyperglycemic risk).
Claims 23, 25-28, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2015/0273147 (“Duke”) in view of US Patent Application Publication 2012/0296311 (“Brauker”).
Regarding claim 23, Duke teaches all the features with respect to claim 21, as outlined above. Duke does not appear to explicitly teach wherein the period of time is at least one day.
Brauker teaches that even short term continuous glucose sensors monitor for 1-7 days, while others can monitor longer than a week, month, or year (¶ 0102).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor for at least one day in Duke, as in Brauker, for the purpose of increasing user convenience (Brauker: ¶ 0102, less frequent replacement).
Regarding claim 25, Duke teaches all the features with respect to claim 21, as outlined above. Duke does not appear to explicitly teach wherein the variability of the glucose concentration data comprises an acceleration of a rate of change of the glucose concentration data.
Brauker teaches using acceleration of glucose concentration to more particularly determine medicament administration (¶ 0114), and to more fully evaluate risk (¶ 0170).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use acceleration of glucose concentration to determine urgency in Duke as in Brauker, for the purpose of being able to respond to more situations of potential risk (Brauker: ¶ 0170).
Regarding claim 26, Duke teaches all the features with respect to claim 21, as outlined above. Duke does not appear to explicitly teach wherein the variability of the glucose concentration data comprises a measure of deviation from one or more normal glucose patterns of the host (although it does talk about using the patient’s historical data for bolus adjustment).
Brauker teaches using patterns associated with a patient’s glucose trends (learned over time) to detect impending risk of e.g. hypoglycemic events (¶¶s 0120, 0151, 0170, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use deviation from normal glucose patterns to determine urgency in Duke as in Brauker, for the purpose of tailoring the monitoring to the individual to help maintain a controlled range of glucose values (Brauker: ¶¶s 0120, 0151, 0170, etc.).
Regarding claim 27, Duke teaches all the features with respect to claim 21, as outlined above. Duke does not appear to explicitly teach wherein the variability of the glucose concentration data comprises a measure of one or more excursions from an expected glucose concentration of the host or a baseline glucose concentration of the host (although it does talk about using the patient’s historical data for bolus adjustment).
Brauker teaches using patterns associated with a patient’s glucose trends (learned over time, and establishing an expected or baseline concentration) to detect impending risk of e.g. hypoglycemic events (¶¶s 0120, 0151, 0170, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use excursions from expected or baseline values to determine urgency in Duke as in Brauker, for the purpose of tailoring the monitoring to the individual to help maintain a controlled range of glucose values (Brauker: ¶¶s 0120, 0151, 0170, etc.).
Regarding claim 28, Duke teaches all the features with respect to claim 21, as outlined above. Duke further teaches wherein the measure of glycemic urgency is determined based on at least the glucose concentration data, the variability of the glucose concentration data (¶ 0067, based on the glucose measurement and its rate of change (variability)), but is not explicit that the urgency is based on at least one user input (although this is suggested by use of history data entered via user input as described in ¶¶s 0052 and 0053, or by user input related to allowed rise value (Fig. 8, ¶¶s 0059-0061)).
Brauker teaches using patterns associated with a patient’s glucose trends (learned over time) to project glucose trends (based on user input) and detect impending risk of e.g. hypoglycemic events (¶¶s 0120, 0151, 0170, etc. – also see ¶¶s 0169, 0171, etc., validating a recommended therapy based on user input, or otherwise incorporating user input data).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine urgency further based on user input data, for the purpose of tailoring the monitoring to the individual to help maintain a controlled range of glucose values (Brauker: ¶¶s 0120, 0151, 0170, etc.), and for having a parameter useful for validating decisions (Brauker: ¶¶s 0169, 0171, etc.).
Regarding claim 40, Duke teaches [a]n integrated system for assessing and responding to glycemic risk (Abstract), the system comprising: a continuous glucose sensor configured to generate glucose concentration data (Figs. 2 and 3, continuous glucose monitoring (CGM) system 50 includes a glucose sensor 56 – also see ¶ 0035), wherein the glucose concentration data indicates glucose concentrations measured in a bodily fluid of a host … (¶ 0035, glucose levels in interstitial fluid – also see the x-axis of Fig. 1); an insulin delivery device configured to deliver insulin according to one or more generated insulin delivery commands (Fig. 2, therapy delivery device/insulin pump 84); and a control device operably connected to the continuous glucose sensor and the insulin delivery device (Fig. 2, computing device 66), the control device comprising: at least one processor (Fig. 3, processor(s) 72); and at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the control device (Fig. 3, memory 76 – also see ¶¶s 0038, 0039, and 0094) to: receive the glucose concentration data from the continuous glucose sensor (¶ 0035 – also see the x-axis of Fig. 1); analyze the glucose concentration data to determine a measure of glycemic urgency (Fig. 3, hazard analysis logic 80 – also see Fig. 10, steps 152-158, etc.), wherein the measure of glycemic urgency is determined based at least in part on an assessment of variability of the glucose concentration data, the variability of the glucose concentration data comprising: a rate of change of the glucose concentration data (¶ 0067, the glucose state from which risk is calculated is based on e.g. rate of change of glucose level); an acceleration of the rate of change of the glucose concentration data; a measure of deviation from one or more normal glucose patterns of the host; and/or a measure of one or more excursions from an expected glucose concentration of the host or a baseline glucose concentration of the host; compare the measure of glycemic urgency to one or more thresholds of glycemic risk, wherein the one or more thresholds of glycemic risk comprise: physiological conditions indicative of hypoglycemic risk; and/or physiological conditions indicative of hyperglycemic risk (Figs. 6-9, ¶¶s 0067 and 0068, e.g. a positive or negative value); respond to a determination that the measure of glycemic urgency exceeds at least one threshold of the one or more thresholds of glycemic risk by modifying insulin delivery (Fig. 10, step 162, adjusting the basal rate), wherein modifying insulin delivery comprises: generating one or more insulin delivery commands to reduce or suspend insulin delivery when the at least one threshold of glycemic risk comprises physiological conditions indicative of hypoglycemic risk (¶¶s 0069, 0080, etc., basal shutoff); and/or generating one or more insulin delivery commands to increase insulin delivery when the at least one threshold of glycemic risk comprises physiological conditions indicative of hyperglycemic risk (¶ 0067, adjusting basal rate based on hyperglycemic risk – also see Fig. 10, blocks 176 and 166, which do not contemplate only decreasing the basal rate); and transmit the generated one or more insulin delivery commands to the insulin delivery device (Fig. 10, block 168).
Duke does not appear to explicitly teach the glucose data corresponding to measurements over a period of at least one day.
Brauker teaches that even short term continuous glucose sensors monitor for 1-7 days, while others can monitor longer than a week, month, or year (¶ 0102).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor for at least one day in Duke, as in Brauker, for the purpose of increasing user convenience (Brauker: ¶ 0102, less frequent replacement).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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