DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The claims are objected to because the numbering of claims are improper, multiple claims are numbered 4 and 5. For purposes of examination, examiner will be examining the claims as renumbered 1-10.
Due to the renumbering, claim 10 reads, “the system according to claim 7,…”, but should read, “the system according to claim 9…”.
Claims 3 and 4 are also objected to for the recitation of “any of claims 1” in line 1 as these recitations are grammatically incorrect.
Appropriate correction is required.
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 35 U.S.C. 112 (pre-AIA ), 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.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the dose request" in line 9. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, examiner interprets “the dose request” as “a dose request”.
Claims 2-10 are rejected due to being dependent on claim 1.
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 1-10 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.
Each of Claims 1-10 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-10 recites at least one step or instruction for receiving data such as acoustic data, image data to determine an air leak and provide an indicator to indicate the location of the air leak which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-10 recites an abstract idea.
Specifically, Claim 1 recites:
A system to control glycemia in a patient, the system comprising:
a controller (additional element) configured to:
receive glucose data at intervals (extra solution activity);
determine a glucose target (abstract idea);
execute a model-predictive controller algorithm to predict physiological glucose values and to solve an objective function for an optimal insulin trajectory, the objective function comprising a sum of weighted differences between the predicted physiological glucose and the glucose target (abstract idea); and
determine the dose request from the optimal insulin trajectory and transmit the dose request (abstract idea).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent claims 2-10 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in independent Claim 1 (and its respective dependent claims, 2-10) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claim 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of:
A controller
are generically recited computer elements in independent claim 1 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (a computing device, control system including one or more processors, and a computer claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 1 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent claim 1 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of claims 1-10 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of:
A controller, as recited in independent claim 1 and its dependent claims.
The above-identified additional elements are generically claimed structural/computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the controller includes control logic operative to integrate the data, execute the algorithm, and control the pump, can include at least one processor (e.g., microprocessor), it executes software and/or firmware stored in memory of the controller . The software/firmware code contains instructions that, when executed by the processor, cause the controller to perform the functions of the control algorithm (Para [0022] and [0026]).
Accordingly, in light of Applicant’s specification, the claimed controller is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the controller. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that 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) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activities previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in claims 1-10 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus of claims 1-10 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of claims 1-10 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent claim 1 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, claims 1-10 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the claims 1-10 amounts to significantly more than the abstract idea itself.
Accordingly, claims 1-10 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
It is recommended to further add limitation similar to claim 2 such as “an insulin delivery device delivering insulin to the patient, in response to the determined dose request” which provides a closed-loop to the calculations; therefore, integrating it into practical application.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-4 and 8 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by
Damiano et al. (US Pub No. 20110106049 A1, herein, Damiano).
Regarding claim 1, Damiano discloses a system to control glycemia in a patient, the system comprising:
a controller (18 – Fig.1) configured to:
receive glucose data at intervals (“continually sample a glucose level of the subject” – Para [0012]);
determine a glucose target (“setpoint signal r(t+k)” – Para [0013], “target blood glucose level” – Para [0012]);
execute a model-predictive controller algorithm to predict physiological glucose values and to solve an objective function for an optimal insulin trajectory (Fig.4, “generates a predicted future glucose level signal y(t+k|t)” – para [0013]), the objective function comprising a sum of weighted differences between the predicted physiological glucose and the glucose target (“a weighted integration of a difference between the predicted glucose level signal and the setpoint signal over a time horizon” – Fig.4); and
determine the dose request (“a dose control signal u(t)” – Para [0013]) from the optimal insulin trajectory and transmit the dose request (“the objective function optimizer computes future error signals which are used to synthesize the dose control in an optimizing fashion based on a model predictive control (MPC) algorithm” – [0014], Para [0033]).
Regarding claim 2, Damiano discloses the system as set forth above, further comprising: an insulin delivery device (14 – Fig.1) for delivering insulin to the patient, in response to the determined dose request (“An amount of insulin or glucagon corresponding to the input signal u(t) is physically administered to the subject via the delivery device” – Para [0014]).
Regarding claim 3, Damiano discloses the system as set forth above, further comprising: a glucose measurement device (16 – Fig.1) in communication with the controller (Fig.1, “controller controls operation of the delivery device as a function of a glucose level signal from the glucose sensor” – Para [0012]) and for measuring the glucose data, including a glucose concentration, in the patient (“continually sample a glucose level of the subject” – Para [0012]).
Regarding claim 4, Damiano discloses the system as set forth above, wherein weighting of the weighted differences comprises applying a weighting function to the differences between the predicted physiological glucose and the glucose target (“a weighted integration of a difference between the predicted glucose level signal and the setpoint signal over a time horizon” – Fig.4).
Regarding claim 8, Damiano discloses the system as set forth above, wherein the glucose target is a function of at least one of: a prescribed target glucose level, exercise, or time after meal (“user-provided parameter is a "setpoint" which, as described below, establishes a target blood glucose level” – Para [0012]).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Damiano in view of Diebold et al. (US Pub No. 20160287184 A1, herein, Diebold).
Regarding claim 6, Damiano discloses the system as set forth above, wherein the objective function and weighting of the weighted differences are based on the weight of the patient, however, Damiano does not expressly disclose wherein the objective function and weighting of the weighted differences are based on one or more of: time since meal, meal size, or exercise level.
Diebold teaches an objective function and weighting of the weighted differences are based on one or more of: time since meal, meal size, or exercise level (“The prediction model may include additional predicted inputs such as anticipated meals, insulin, exercise, or other anticipated future inputs” – Para [0153]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the objective function and weighting of the weighted differences disclosed by Diebold to be based on exercise as taught by Diebold since Diebold teaches that when determining a prediction of the glucose level of a person using a prediction algorithm, it is well known that using meals and exercise is a factor, therefore it would be well known for the objective function and weighting of the weighted differences to be dependent on these factors.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Damiano in view of Morales (US Pub No. 20140276555 A1).
Regarding claim 9, Damiano discloses the system as set forth above, however, Damiano does not expressly disclose wherein the objective function further comprises a sum of basal deviations from a basal insulin profile.
Morales teaches a system wherein the objective function further comprises a sum of basal deviations from a basal insulin profile (“compute a deviation of the candidate insulin delivery amounts from respective selected basal delivery amounts - [0076], “form a weighted sum of respective values representing the predicted excursion and the computed deviation using respective selected weights, such that the output of the cost function includes the weighted sum.” – Para [0077]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the objective function disclosed by Damiano to comprise a sum of basal deviations from a basal insulin profile as taught by Morales since Morales teaches it is well known to have the objective function comprise a sum of basal deviations from a basal insulin profiles in a model predictive controller which is adapted to determine the insulin delivery amount (Morales, Para [0056]).
Allowable Subject Matter
Claims 5, 7, and 10 would be allowable if rewritten in independent form and to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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