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 I, Claims 1-19, in the reply filed on 28 May 2026 is acknowledged. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/group, there being no allowable generic or linking claim.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 1-19 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, without significantly more.
Step 1
The claimed inventions in claims 1-19 are directed to statutory subject matter as the claim(s) recite(s) a method of presenting the impedance status of electrodes.
Step 2A, Prong One
Claim 1 recites the following steps or instructions for “selecting one of the at least one type of electrode-based sensor”, “providing…the location for each of the plurality of electrodes”, “receiving impedance data…”, “displaying…an applicable impedance status”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III). For example, the limitations concern data acquisition, data interpretation, and data visualization directed to mental processes of performing concepts in a human mind or by a human using a pen and paper. For example, these limitations are nothing more than a medical professional selecting which electrodes to provide information on, visually representing, by hand on a piece of paper, the position of the electrodes based on the stored or live data, receiving impedance data, and providing an impedance status for each electrode on that same visual presentation on a paper. The limitation of “storing electrode data…” is considered a presolution data gathering step.
Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claim 1 recites additional elements of a “patient monitoring system” and “display”.
Step 2A, Prong Two
The above-identified abstract idea in each of independent Claim 1 (and respective dependent claims 2-19) is not integrated into a practical application under MPEP 2106.04(d) 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 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 elements of: “patient monitoring system” and “display” are generically recited computer elements in independent Claim 1 (and respective dependent claims 2-19) which do 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 1 (and respective dependent claims 2-19) 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) using rules (e.g., computer instructions) executed by a computer (e.g. “patient monitoring system” and “display” 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 Claim 1 (and respective dependent claims 2-19) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claim 1 (and respective dependent claims 2-19) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claim 1 does 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 elements of: “patient monitoring system” and “display” as recited in independent Claim 1 (and respective dependent claims 2-19).
The above-identified additional elements are 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.
Per Applicant’s specification:
A “patient monitoring system” and “display” is described in the disclosure as a component that is generic and conventionally used and known in the art (¶¶ 34-36 – published app).
Additionally, the claimed term terms are 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 “patient monitoring system” and “display”. 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 Claim 1 (and respective dependent claims 2-19) is 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 1 (and respective dependent claims 2-19) 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 1 (and respective dependent claims 2-19) 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 § 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 1-19 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 pre-AIA the applicant regards as the invention. Claim 1 recites the language, “storing electrode data…comprising… a location of each of each of the plurality of electrodes on a representation of at least a portion of a human body…”. It is unclear and confusing as to what the representation is, and how that representation is acquired or determined. In addition…the additional data of “a plurality of impedance statuses…” is unclear as to whether these are predetermined, premeasured, acquired, calculated, etc. Further clarification is required.
Claims 2-19 are rejected under the same rationale as being dependent upon claim 1 and its limitations.
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 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 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sunderland et al. (US 2014/0243643; hereinafter “Sunderland”).
Regarding claim 1, Sunderland teaches a method comprising: (a) storing electrode data associated with each of at least one type of electrode-based sensor, each of the at least one type of electrode-based sensor having a plurality of electrodes (e.g. ¶¶ 28), the electrode data comprising (1) a label for each of each of the plurality of electrodes (e.g. Fig. 15 – #494-514), (2) a location of each of each of the plurality of electrodes on a representation of at least a portion of a human body or an electrode-retaining device (e.g. Fig. 15, #492), and (3) a plurality of impedance statuses comprising a low impedance status and a high impedance status (e.g. Fig. 15, 520/524), the electrode data being accessible by a patient monitoring system having a display (e.g. ¶¶ 28, 61-65, etc.); (b) selecting one of the at least one type of electrode-based sensor (e.g. ¶¶ 37); (c) for the at least one type of electrode-based sensor detected in step (b), providing on the display a graphical representation of the location for each of the plurality of electrodes stored in step (a) (e.g. Fig. 15, #492); (d) receiving impedance data for each of the plurality of electrodes of the at least one type of electrode-based sensor detected in step (b) (e.g. ¶¶ 61-65, 159-163, etc.); and (e) displaying on the display the label and an applicable impedance status for each of the plurality of electrodes as a function of the plurality of impedance statuses stored in step (a) and the impedance data received in step (d) (e.g. Fig. 15; ¶¶ 82, 100, 143, etc.).
Regarding claim 2, Sunderland discloses displaying an electrode failure alert if any of the applicable impedance status displayed for any of the in step (e) comprises an impedance status other than the low impedance status (e.g. ¶¶ 145).
Regarding claim 3, Sunderland discloses displaying patient physiologic data gathered the at least one type of electrode- based sensor selected in step (b) in a physiologic data window in the display (e.g. ¶¶ 28 – “displaying the electrical signals on a display”).
Regarding claim 4, Sunderland discloses displaying in the physiologic data window patient physiologic data gathered by at least one sensor other than the at least one type of electrode-based sensor selected in step (b) (e.g. ¶¶ 28, 31, 61-65, etc.).
Regarding claim 5, Sunderland discloses the label and an applicable impedance status for each of the plurality of electrodes displayed pursuant to step (e) is displayed in the form of a table (e.g. ¶¶ 61-65, 159-163, etc.).
Regarding claim 6, Sunderland discloses the table is positioned adjacent to the graphical representation of step (c) (e.g. ¶¶ 61-65).
Regarding claim 7, Sunderland discloses associating an icon with each of plurality of impedance statuses (e.g. Fig. 15, #520/522/524).
Regarding claim 8, Sunderland discloses displaying the icon associated with the applicable impedance status for each of the plurality of electrodes determined in step (d) superimposed on the location of the electrode displayed in the graphical representation of step (c) (e.g. Fig. 15, #492).
Regarding claim 9, Sunderland discloses displaying the label and location of the electrode displayed in the graphical representation of step (c) without an impedance status (e.g. ¶¶ 172 – where the examiner notes it would show up as poor if there is no impedance status).
Regarding claim 10, Sunderland discloses the graphical representation displayed in step (c) comprises the representation of the at least a portion of a human body or the electrode- retaining device stored in step (a) (e.g. Fig. 15, #492).
Regarding claim 11, Sunderland discloses the graphical representation displayed in step (c) comprises the representation of the at least a portion of a human body (e.g. Fig. 2, #132).
Regarding claim 12, Sunderland discloses the graphical representation displayed in step (c) comprises a chest view and a full body view (e.g. Fig. 2, #132).
Regarding claim 13, Sunderland discloses the graphical representation displayed in step (c) is user selectable (e.g. ¶¶ 132, 137, etc.).
Regarding claim 14, Sunderland discloses the plurality of impedance statuses further comprises a medium impedance status (e.g. Fig. 15 – where the examiner considers FAIR #522 to be the medium impedance status).
Regarding claim 15, Sunderland discloses selecting one of the at least one type of electrode-based sensor based on user input to the display (e.g. ¶¶ 37, 81, 92, etc.).
Regarding claim 16, Sunderland discloses selecting one of the at least one type of electrode-based sensor by detecting a connection between the selected one of the at least one type of electrode-based sensor and a sensor interface of the patient monitoring system (e.g. ¶¶ 37, 81, 92, etc.).
Regarding claim 17, Sunderland discloses the patient monitoring system is capable of performing steps (c) and (e) for each of the at least one type of electrode-based sensor (e.g. ¶¶ 26, 84, etc.).
Regarding claim 18, Sunderland discloses the at least one type of electrode-based sensor comprises an ECG sensor and a BISx sensor (e.g. ¶¶ 26, 84, etc.).
Regarding claim 19, Sunderland discloses the at least one type of electrode-based sensor further comprises an EEG sensor and a NMT sensor (e.g. ¶¶ 26, 84, etc.).
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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