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 .
Formal Matters
Applicant's response, filed 03 September 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 21-42 are currently pending and have been examined.
Claims 1-5, 8-14 and 17-20 have been canceled.
Claims 21-42 have been rejected.
Priority
The instant application claims the benefit of priority under 35 U.S.C 119(e) or under 35 U.S.C. § 120, 121, or 365(c). Accordingly, the effective filing date for the instant application is 19 July 2021 claiming benefit to Provisional Application 63/223429.
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 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) 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):
(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 limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) 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) 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) because the claim limitation 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 a claim limitation is:
blood glucose measurement unit in claims 21, 33, and 38. The specification fails to disclose any structure for the blood glucose measurement unit.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f), it is 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 limitation interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitation(s) to avoid it being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f).
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 21-42 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 21-42 are drawn to a method, manufacture, or system which are statutory categories of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 1 recites a method. Independent claim 33 recites one or more non-transitory computer-readable storage media. Independent claim 38 recites a system.
These independent claims recite the following steps best characterized as a method of organizing human activity under MPEP § 2106.04(a)(2)(II) citing the abstract idea grouping for methods of organizing human activity in general:
receiving… a plurality of measurement values of a blood glucose level of a patient measured by a blood glucose measurement unit
receiving… a dose plan prescribed for the patient, the dose plan comprising: (i) a plurality of dose adjustment rules for adjusting a dose of a first type of insulin, (ii) a dose maintenance rule for maintaining a dose of a second type of insulin, the second type of insulin being a different insulin from the first type of insulin, the dose maintenance rule specifying a maintenance dose value of the second type of insulin, and (iii) a hypoglycemic condition, wherein the dose plan requires the dose of the first type of insulin to be adjusted while the dose of the second type of insulin is maintained
determining (i) a next dose value of the first type of insulin by adjusting a prior dose value of the first type of insulin in accordance with the plurality of dose adjustment rules and the plurality of measurement values, and (ii) a next dose value of the second type of insulin by setting the next dose value of the second type of insulin to the maintenance dose value specified by the dose maintenance rule;
causing the next dose value of the first type of insulin and the next dose value of the second type of insulin to be displayed;
determining, based on the plurality of measurement values, that the hypoglycemic condition has occurred; and
in response to determining that the hypoglycemic condition has occurred, withholding determination of further next dose values of the first type of insulin, such that no further next dose value of the first type of insulin is caused to be displayed, until a modification to at least one of the plurality of dose adjustment rules is received
Under the broadest reasonable interpretation of the limitations, these steps amount to methods of organizing human activity which includes functions relating to interpersonal and intrapersonal activities, such as managing relationships or transactions between people, social activities, and human behavior (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people similar to iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982) – also note MPEP § 2106.04(a)(2)(II) stating certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping).
Dependent claim 22 recites, in part, wherein the first type of insulin is basal insulin and the second type of insulin is bolus insulin.
Dependent claim 23 recites, in part, wherein the first type of insulin is bolus insulin and the second type of insulin is basal insulin.
Dependent claim 24 recites, in part, wherein the plurality of measurement values of the blood glucose level comprises a plurality of fasting blood glucose values.
Dependent claim 25 recites, in part, wherein the plurality of measurement values of the blood glucose level comprises a plurality of postprandial blood glucose values.
Dependent claim 26 recites, in part, determining whether a hypoglycemic event has occurred based on the plurality of measurement values; and in response to determining that the hypoglycemic event has occurred, causing a prompt to contact a health care provider to be displayed on the first computing device.
Dependent claim 27 recites, in part, wherein determining whether the hypoglycemic event has occurred comprises determining whether at least one of the plurality of measurement values is below a hypoglycemic blood glucose threshold.
Dependent claim 28 recites, in part, further comprising, in response to determining that the hypoglycemic condition has occurred, withholding determination of further next dose values of the second type of insulin, such that no further next dose value of the second type of insulin is caused to be displayed.
Dependent claim 29 recites, in part, wherein the dose plan further specifies a titration interval and a minimum number of measurement values, and wherein the method further comprises withholding determination of the next dose value of the first type of insulin until a number of the plurality of measurement values received during the titration interval satisfies the minimum number.
Dependent claim 30 recites, in part, wherein the plurality of dose adjustment rules specify that, where two or more of the plurality of measurement values received within a titration interval are below a hypoglycemic blood glucose threshold, the next dose value of the first type of insulin is determined from a lowest one of the two or more of the plurality of measurement values and not from a cumulative combination of the two or more measurement values.
Dependent claim 31 recites, in part, wherein the hypoglycemic condition is satisfied by (a) a measurement value in the plurality of measurement values generated after a bedtime measurement and before a fasting blood glucose measurement being below a hypoglycemic blood glucose threshold, or (b) two or more of the plurality of measurement values generated within a titration interval being below the hypoglycemic blood glucose threshold.
Dependent claim 32 recites, in part, wherein the plurality of dose adjustment rules define three or more contiguous ranges of the blood glucose level, and wherein adjusting the prior dose value of the first type of insulin comprises: where a measurement value in the plurality of measurement values is within a first of the three or more contiguous ranges, adjusting the prior dose value by a predetermined amount of insulin; where the measurement value is within a second of the three or more contiguous ranges, adjusting the prior dose value by a predetermined percentage of the prior dose value; and where the measurement value is within a third of the three or more contiguous ranges, making no adjustment to the prior dose value.
Dependent claim 34 recites, in part, wherein the operations further comprise, in response to determining that the hypoglycemic condition has occurred, withholding determination of further next dose values of the second type of insulin, such that no further next dose value of the second type of insulin is caused to be displayed.
Dependent claim 35 recites, in part, wherein the dose plan further specifies a titration interval and a minimum number of measurement values, and wherein the operations further comprise withholding determination of the next dose value of the first type of insulin until a number of the plurality of measurement values received during the titration interval satisfies the minimum number.
Dependent claim 36 recites, in part, wherein the plurality of dose adjustment rules specify that, where two or more of the plurality of measurement values received within a titration interval are below a hypoglycemic blood glucose threshold, the next dose value of the first type of insulin is determined from a lowest one of the two or more of the plurality of measurement values and not from a cumulative combination of the two or more measurement values.
Dependent claim 37 recites, in part, wherein the plurality of dose adjustment rules define three or more contiguous ranges of the blood glucose level, and wherein adjusting the prior dose value of the first type of insulin comprises: where a measurement value in the plurality of measurement values is within a first of the three or more contiguous ranges, adjusting the prior dose value by a predetermined amount of insulin; where the measurement value is within a second of the three or more contiguous ranges, adjusting the prior dose value by a predetermined percentage of the prior dose value; and where the measurement value is within a third of the three or more contiguous ranges, making no adjustment to the prior dose value.
Dependent claim 39 recites, in part, update the data [] in response to receiving a modification to at least one of the plurality of dose adjustment rules; and refrain from resuming determination of next dose values of the first type of insulin until the modification to at least one of the plurality of dose adjustment rules is received.
Dependent claim 40 recites, in part, in response to determining that the hypoglycemic condition has occurred, withhold determination of further next dose values of the second type of insulin, such that no further next dose value of the second type of insulin is caused to be displayed.
Dependent claim 41 recites, in part, wherein the dose plan further specifies a titration interval and a minimum number of measurement values, and withhold determination of the next dose value of the first type of insulin until a number of the plurality of measurement values generated during the titration interval satisfies the minimum number.
Dependent claim 42 recites, in part, wherein the plurality of dose adjustment rules define three or more contiguous ranges of the blood glucose level, and adjust the prior dose value by: where a measurement value in the plurality of measurement values is within a first of the three or more contiguous ranges, adjusting the prior dose value by a predetermined amount of insulin; where the measurement value is within a second of the three or more contiguous ranges, adjusting the prior dose value by a predetermined percentage of the prior dose value; and where the measurement value is within a third of the three or more contiguous ranges, making no adjustment to the prior dose value.
Each of these steps of the preceding dependent claims only serve to further limit or specify the features of independent claims accordingly, and hence are nonetheless directed towards fundamentally the same mental process abstract idea grouping as the independent claim and utilize the additional elements analyzed below in the expected manner.
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
Independent claim 21 recites a data processing system, a first wireless link, a first computing device, a second wireless link, a second computing device. Independent claim 33 recites one or more non-transitory computer-readable storage media coupled to one or more processors, first wireless link, a first computing device, a second wireless link, and a second computing device. Independent claim 38 recites a display device, a data storage for storing the data utilized via the abstract idea, and one or more processors. Claims 21 and 33 recite establishing, at a data processing system, a first wireless communication link to a first computing device and a second wireless communication link to a second computing device. The computer and corresponding hardware are recited as a tool to apply data to an algorithm and report the results (MPEP § 2106.05(f)(2) see case involving a commonplace business method or mathematical algorithm being applied on a general purpose computer within the “Other examples.. i.”) amounting to instruction to implement the abstract idea using a general purpose computer. Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S. Ct. 2347, 1357 (2014).
Independent claim 38 recites a blood glucose measurement unit configured to generate a plurality of measurement values of a blood glucose level of a patient. The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
Claims 21 and 33 recite receiving, at the data processing system from the first computing device via the first wireless communication link, a plurality of measurement values of a blood glucose level. Claims 21 and 33 recites receiving, at the data processing system from the second computing device via the second wireless communication link, a dose plan. The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer.
Independent claim 21 recites a data processing system, a first wireless link, a first computing device, a second wireless link, a second computing device. Independent claim 33 recites one or more non-transitory computer-readable storage media coupled to one or more processors, first wireless link, a first computing device, a second wireless link, and a second computing device. Independent claim 38 recites a display device, a data storage for storing the data utilized via the abstract idea, and one or more processors. Claims 21 and 33 recite establishing, at a data processing system, a first wireless communication link to a first computing device and a second wireless communication link to a second computing device.
Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the storage mediums to store data, the computer and data processing devices to apply the algorithm, and the display device to display selected results of the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”).
Each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements do not have sufficient structure in the specification to be considered a not well-understood, routine, and conventional use of generic computer components. Note that the specification can support the conventionality of generic computer components if “the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a)” (MPEP § 2106.07(a)(III)(A) integrating the evidentiary requirements in making a § 101 rejection as established in Berkheimer in III. Impact on Examination Procedure, A. Formulating Rejections, 1. on p. 3).
Independent claim 38 recites a blood glucose measurement unit configured to generate a plurality of measurement values of a blood glucose level of a patient. The courts have decided that determining the level of a biomarker in blood by any means as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II)).
Claims 21 and 33 recite receiving, at the data processing system from the first computing device via the first wireless communication link, a plurality of measurement values of a blood glucose level. Claims 21 and 33 recites receiving, at the data processing system from the second computing device via the second wireless communication link, a dose plan. The courts have decided that receiving or transmitting data over a network as well-understood, routine, conventional activity when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II) other types of activities example i. receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network).
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
Claims 21-42 are therefore rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Claim Rejections – 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a)-(b):
(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.
(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.
Claims 21-42 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims 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 had possession of the claimed invention. The specification fails to disclose any structure for the blood glucose measurement unit and is therefore without a description of elements to perform the function (see MPEP § 2181(II)(A) and (IV)).
Claims 22-32, 34-37, and 39-42 depend on claims 21, 33, and 28 and do not remedy the written description requirement issues of the independent claims. As dependent claims inherit the deficiencies of the claims they depend on, they are also rejected.
Claims 21-42 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim limitations "blood glucose measurement unit (Claims 21, 33, and 38)" invoke 35 U.S.C. 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function (see MPEP § 2181(III)(A)). The specification fails to have any specific hardware for performing the claimed steps. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b). Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f);
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one
of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 22-32, 34-37, and 39-42 depend on claims 21, 33, and 28 and do not remedy the indefiniteness issues of the independent claims. As dependent claims inherit the deficiencies of the claims they depend on, they are also rejected.
Response to Arguments
Applicant's arguments filed with respect to 35 USC § 101 have been fully considered but they are not persuasive.
Step 2A – Judicial Exception Analysis, Prong 1:
Applicant first asserts that the claims do not recite a method of organizing human activity as the claim does not recite a person as an actor and fails to identify interpersonal activity. Examiner is not persuaded. There is no test in the MPEP § 2106.04(a)(2)(II) that requires a claim to positively recite actors. The claims are directed towards collecting blood glucose data from obviously a human patient and determining a next dosage OR withhold a determination until a provider intervenes. Analyzing the data on a general purpose computer/s does not disqualify a claim from reciting an abstract idea generally or a method of organizing human activity specifically. While the generic computers and network connections is treated as additional elements under Step 2A Prong 2 and Step 2B, the limitations performed by said computers may still be considered abstract.
Applicant’s assertion that the instant claims are analogous to Ex parte Block is not persuasive. Ex parte Block is directed towards a closed loop artificial pancreas wherein the insulin is delivered automatically via an insulin pump (see the allowed claimed filed 12/16/2020). The Board Decision did not fail to recognize the recitation of an abstract idea as purported by Applicant, but instead found the claims analogous to Diamond v Diehr wherein while an abstraction was claimed, the claim as a whole was directed towards a meaningful limitation beyond generally linking. Applicant’s assertion that the Board’s failure to address the abstract idea grouping directly as an indication that no abstract idea grouping could be identified is not supported – see p. 7 of the Decision, the Board makes clear that the application of the treatment step is not abstract/a method of organizing human activity, not Applicant’s overstatement that the determination of said treatment alone is ALSO not a method of organizing human activity. Therefore, Examiner is unpersuaded as the instant claims recite no such treatment step.
Applicant’s assertion that the instant claims are analogous to Ex Parte Desjardins. As no machine learning or improvement to machine learning is present in the instant claims, Examiner is unpersuaded of the relevance of the decision.
Step 2A – Judicial Exception Analysis, Prong 2:
Applicant asserts that the withholding and resumption limitations are additional elements. Examiner is not persuaded. While the transmission of data generally between two devices is considered an additional element (even insofar as it is performed on via a generic computer), the algorithmic logic behind the performance or the data included in said transmission itself is considered abstract.
Applicant asserts that the stopping of an algorithm in response to a triggering event is a meaningful limitation beyond generally linking similar to that of Diamond v Diehr. Examiner is unpersuaded. Ceasing a computational operation until further information is provided is not analogous to the physical rubber stamping process of Diehr. No such mechanical structure is present in the instant claims. The instant claims are directed towards applying an abstract idea in a generic computing environment.
Applicant’s assertion that the instant claims are similar to DDR Holdings is also not persuasive. DDR Holdings is directed towards a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage. Here, the stopping and starting of an insulin recommendation algorithm until a practitioner reviews the data and sending a transmission over a generic computer network is not an unconventional technical solution to a technical problem. The problem in the instant specification is instead directed towards the abstract idea of glucose management generally. There is no support in the instant application that the newly amended “withholding a recommendation step” solves any particular problem (it is merely recited generally as an option in the specification on p. 18 lines 7-10 and 20-22) much less a known technical problem over the prior art.
Applicant then asserts that the instant claims amount to a particular machine. Examiner is unpersuaded. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions). Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223-24, 110 USPQ2d 1976, 1983-84 (2014). See In re Alappat, 33 F.3d 1526, 1545, 31 USPQ2d 1545, 1558 (Fed. Cir. 1994); In re Bilski, 545 F.3d 943, 88 USPQ2d 1385 (Fed. Cir. 2008)(see MPEP § 2106.05(b)(I) for more information). The inclusion of a generic “measurement unit” merely for collecting data or a “communication link” (see analysis above as this is a generic computer component) does not meaningfully change the analysis. Under the factors for consideration, the machine (I) is particular of the elements and can be specifically identified (here a “measurement unit” could be any possible device that can performed any measurement), (II) integrates the recited judicial exception into a practical application (here the use sensor readings are mere data gathering), and (III) poses meaningful limits on the claim (here the abstract idea has no affect on the performance of the “measurement unit”).
Next, Applicant asserts that the withholding and resuming functions is an improvement to technology. Examiner is wholly unpersuaded. Again, the stopping and starting of an insulin recommendation algorithm until a practitioner reviews the data and sending a transmission over a generic computer network is not an unconventional technical solution to a technical problem. The problem in the instant specification is instead directed towards the abstract idea of glucose management generally. There is no support in the instant application that the newly amended “withholding a recommendation step” solves any particular problem (it is merely recited generally as an option in the specification on p. 18 lines 7-10 and 20-22) much less a known technical problem over the prior art. The passage Applicant relies on to support the improvement further demonstrates the improvement is directed towards the abstract idea of “allowing [health care providers] to prescribe a more complex dose plan… and to easily modify the prescribed dose plan as necessary”. An improvement to the abstract idea health care provider monitor and control of insulin dosage plans does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”).
Examiner further notes , the use of a conditional statement to terminate (or restart) a computer program process when a decision is made (while abstract in nature) is nonetheless not an unconventional solution - this position is supported by Control! Statements, Rochester Institute of Technology (Jan 31, 2001) teaching on exiting an algorithm if a condition is met. Algorithm entrance and exit conditions are fundamental concepts of procedural logic, algorithms, and structured programming.
Step 2B – Additional Elements that Amount to Significantly More:
Applicant asserts that Examiner failed to address the combination of additional elements – specifically the disabling and re-enabling of a function performed on the computer. Firstly, Examiner notes these limitations were not addressed as they were not included in the previous action. Furthermore, the steps are not analyzed in the current rejection as the stopping and starting of an algorithm is not an additional element, it is a conventional computer algorithm design that is abstract in nature. The consideration under Step 2B is if the additional elements, alone or in combination, are well-understood, routine and conventional in the field – the novelty of the abstract idea is not considered relevant under the Step 2B analysis. Here, the additional elements, alone or in combination, amount to instruction to implement the abstract idea using a general purpose computer. Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S. Ct. 2347, 1357 (2014).
Applicant then states that “MPEP § 2106.05(d) and the Berkheimer guidance, an absence of structural detail in the specification is a reason the conventionality of a generic component need not be separately evidenced; it is not itself evidence that a claimed arrangement of those components was conventional. The two propositions are distinct, and the second is the one the rejection requires.” Examiner is not persuaded that there is any support in any part of the instant disclosure that there is an unconventional arrangement of generic computer parts that would require additional evidence of conventionality.
Applicant’s arguments with respect to 35 USC § 103 have been considered and are persuasive regarding the newly added limitations. Therefore, the rejection has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Dobbles et al. (US 2014/0052095 A1) configured to stop insulin delivery and/or sound an alarm, if the host's glucose falls below the target range and/or within a dangerous range (e.g., hypoglycemic, such as less than 70 mg/dl).teaching on stopping insulin delivery and sounding an alarm, if the host's glucose falls below the target range or is within a dangerous range (e.g., hypoglycemic) in the Detailed Description in ¶ 0293
O’Connor et al. (US 2023/0181824 A1) teaching on stopping the delivery of insulin when a hypoglycemic event is detected in the Detailed Description in ¶ 0047
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JORDAN LYNN JACKSON whose telephone number is (571)272-5389. The examiner can normally be reached Monday-Friday 8:30AM-4:30PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arleen M Vazquez can be reached at 571-272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JORDAN L JACKSON/Primary Examiner, Art Unit 2857
