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 .
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 12-21, in the reply filed on 9 March 2026 is acknowledged. Claims 1-11 and 22-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/group, there being no allowable generic or linking claim.
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 12-21 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are determined to be directed to a judicial exception, specifically an abstract idea and/or mathematical concept, without significantly more.
Step 1
The claimed inventions in claims 12-21 are directed to statutory subject matter as the claim(s) recite(s) a method of quantifying, managing, and maintaining performance of an implantable medical device (IMD).
Step 2A, Prong One
Claim 12 recites the following steps or instructions for “receiving…code path information…”, “processing…the code path information…”, “calculating…at least one power consumption metric”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or mathematical concept in MPEP 2106.04(a)(2)(I).
The limitations concern data collection, data analysis and metric calculations which is directed to mental processes of performing concepts in a human mind or by a human using a pen and paper and mathematical concepts. For example, these limitations are nothing more than a medical professional receiving data, organizing that data, and then calculating power consumption metrics based on that data, using mathematical concepts.
Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claim 12 recites additional steps of “generating…instructions to reset…” and “transmitting…the instructions…” and additional element of “at least one processor”.
Step 2A, Prong Two
The above-identified abstract idea in independent Claim 12 (and dependent claims 13-21) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claim 12), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and appear to be extra solution activity where data to be analyzed by the abstract idea is acquired or obtained.
More specifically, the additional steps of: “generating…instructions to reset…” and “transmitting…the instructions…” recite instructions to “apply” the abstract idea of performing activities not related to quantifying, managing, or maintaining the IMD or administration of treatment or therapy to a patient, at any level of detail.
The additional element of “at least one processor” is a generically recited computer elements which does not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) 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 according to MPEP 2106.04(d)(2) and 2106.05(e). 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 in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claim 12 (and dependent claims 13-21) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and using mathematical concepts) using rules (e.g., computer instructions) executed by a computer (e.g. “the at least one processor” as 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 according to MPEP 2106.05(f). 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 according to MPEP 2106.05(a). 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 12 (and dependent claims 13-21) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claim 12 (and dependent claims 13-21) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claim 12 (and dependent claims 13-21) do not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons:
These claims require the additional steps of: “generating…instructions to reset…” and “transmitting…the instructions…” simply recite repetitive calculations (generating) and receiving or transmitting data over a network (transmitting) which are computer functions that are recognized by the courts as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)).
The additional element of “at least one processor” is considered to fall under generically claimed 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, MPEP 2106.05(d)(II) along with 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.
Additionally, the claimed term “at least one processor” 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. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for “the at least one processor”. 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 MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claim 12 (and dependent claims 13-21) 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 MPEP 2106.05(f) along with 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. See MPEP 2106.05(a) along with 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, per MPEP 2106.05(a), 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 method of Claim 12 (and dependent claims 13-21) are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing 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 according to MPEP 2106.04(d)(2) and 2106.05(e).
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 12 (and dependent claims 13-21) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). 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 according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements 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 according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, 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 according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
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.
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 12-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crook et al. (US 2021/0098124; hereinafter “Crook”).
Regarding claim 12, Crook teaches a method for quantifying, managing, and maintaining performance of an implantable medical device (IMD) providing a medical therapy to a patient, the method comprising: receiving, by at least one processor, code path information from the IMD, wherein the code path information comprises one or more identifiers corresponding to a code path executed by at least one firmware module of a plurality of firmware modules of the IMD to control one or more corresponding hardware components for respective IMD functions, and wherein multiple identified code paths traversing respective firmware code instructions are identified for each of the plurality of firmware modules (e.g. ¶¶ 43 – “wirelessly communicating with a separate device, such as a local external device, an implanted device”; ¶¶ 88 – “The energy management module 636 implements the operations described herein in connection with managing energy usage. The dispatcher (described in connection with FIGS. 2 and 3) may be implemented by the energy management module 636 and/or other firmware or hardware.”); processing, by the at least one processor, the code path information to generate respective code path metrics and calculating, by the at least one processor, at least one power consumption metric using one or more respective calculated code path metrics (e.g. ¶¶ 46-48, 57, etc.); generating, by the at least one processor, instructions to reset at least one of the plurality of firmware modules upon determining that the power consumption metric indicates improper IMD operations (e.g. ¶¶ 58 – “the dispatcher 206 may be implemented, as part of the energy management module 14 (FIG. 1), in hardware, firmware or by a processor executing programmable instructions.”); and transmitting, by the at least one processor, the instructions to the IMD via a wireless communication link (e.g. ¶¶ 46 – “The energy management module 14 balances transmission usage and other ED actions that require increased current draw to avoid problematic temporary battery voltage dips”).
Regarding claim 13, Crook discloses the at least one processor is further configured to calculate the at least one power consumption metrics based on weights associated with one or more code paths of the multiple identified code paths, and wherein the weights represent an impact of the one or more code paths on power consumption (e.g. ¶¶ X).
Regarding claim 14, Crook discloses the one or more processors are configured to aggregate information corresponding to one or more executed code paths of the multiple identified code paths, and wherein the at least one power consumption metric is calculated based at least in part on the aggregating (e.g. ¶¶ 31).
Regarding claim 15, Crook discloses the at least one power consumption metric is calculated based on based on an observed code path behavior (e.g. ¶¶ 31).
Regarding claim 16, Crook discloses the at least one power consumption metric comprises a difference between an expected or baseline code path and the observed code path behavior (e.g. ¶¶ 7 – “The charge bank may supply the supplemental power when the energy consumption estimate exceeds the primary source limit. The device operational circuitry may be further configured to implement first or second charge operations based on a type of the ED action. The charge bank may comprise multiple capacitors, from which a subset of the multiple capacitors may be activated based on an amount of the supplemental energy associated with the type of the ED action. The energy consumption estimate may estimate the power demand associated with performing the communicating operation contemporaneous in time with at least one of the monitoring or treating operations. The device operational circuitry may further comprise a dispatcher configured to at least one of skip, delay or modify the at least one of monitoring or treating operation when the energy consumption estimate exceeds a primary source limit of the battery.”).
Regarding claim 17, Crook discloses the expected or baseline code path is determined using a trained artificial intelligence model (e.g. ¶¶ 31, 51, etc.).
Regarding claim 18, Crook discloses the one or more processors are configured to generate a graduated response based on the calculated at least one power metric, wherein the graduated response comprises a plurality of responses, and wherein the reset of the at least one of the plurality of firmware modules comprises one response of the plurality of responses (e.g. ¶¶ 31, 46, etc.).
Regarding claim 19, Crook discloses the plurality of responses comprise a series of escalating responses, and wherein the series of escalating responses include a first response having a lower impact on resources of the IMD relative to a subsequent response in the series of escalating responses (e.g. ¶¶ 52).
Regarding claim 20, Crook discloses the medical therapy comprises a therapy configured to treat a cardiac process of the patient (e.g. ¶¶ 35).
Regarding claim 21, Crook discloses the code path information is received from the IMD with timing information, with sensor data captured by sensors of the IMD, or both, and wherein the one or more processors are configured to modify the medical therapy of the patient based at least in part on the timing information, the sensor data, or both (e.g. ¶¶ 92).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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