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 .
Response to Arguments
Applicant’s arguments with respect to the previous rejection(s) of the claims have been fully considered and are non-persuasive.
With respect to the rejection under 101, applicant contends that the pulse received includes noise and stimulation artifacts and further the noise detection represents a technological process that cannot be performed mentally and must be processed by digital electronic circuitry. The examiner respectfully disagrees and notes that noise removal can be performed by hand using mathematical concepts relative to signal filtering. In addition, the pulse is required to be “indicative” of timing, so the pulse signal could be a basic signal that comprises a minimal number of data points, and filtering out the transitory noise based on threshold values can be done by hand by one of ordinary skill in the art. Applicant links the noise removal to electromagnetic energy; however, the claims do not require that the transitory noise is from this energy, and even if it did, it does not preclude the removal being done by hand as data outliers induced by the noise would be removable using know mathematical concepts and methods. Lastly, with regard to the technological benefits, the examiner notes that the benefits the applicant references in the specification are not required or specified in the functional claim language. Accordingly, the rejection is maintained below.
With respect to the rejection under 112, applicant clarifies that the electrical stimulation system is external to the claimed denoising system; however, the claim still then improperly limits the denoising system by functionally limiting the electrical stimulation system with the language “comprising a neurostimulator”. It is not possible to limit the denoising system by functionally limiting an element which is not a part of the denoising system. Although applicant proposes that this is not done to incorporate the neurostimulator as a claimed element, it is recited in the body of the claim, and in functional language directly tied into the synchronization pulse, which would suggest otherwise. Accordingly, the rejection is maintained below.
With respect to the 102 rejection, applicant contends that the cited sections of Brockway indicate retrospective analysis in which timing information is already known. The examiner notes that this does not preclude the signals in this section from reading on the claim language. The claim language requires receipt of a synchronization pulse “indicative of timing” – this is not limited to a timing pulse or a pulse that is post-hoc vs real-time as the applicant further asserts – rather this can be any pre/post signal which simply provides an indication of timing. There is no need to demonstrate a difference because the claim simply does not require real-time system-to-system communication as the applicant relies upon in the arguments. Similarly, the removal of transitory noise if performed after they have been captured and stored does not preclude the prior art from reading on the claim language. The claim does not require real-time noise removal triggered by receipt of synchronization pulses as the applicant relies upon. Accordingly, the rejection is maintained.
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.
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Claims 18-33 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 invention in claim 18 is directed to a system for removing transitory noise from a signal.
Step 2A, Prong One
Claim 18 recites the following steps or instructions to ”receive a synchronization pulse…”, “remove said transitory noise..”, and “interpolate across a gap..to create a digitized biopotential…”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or mathematical concept in MPEP 2106.04(a)(2)(I).
For example, the limitations concern data collection (receive step), data analysis and recording the results of data analysis which could be done mentally or by hand with pen and paper (remove said transitory noise and interpolate across a gap steps), 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 and removing the transitory noise in the biopotential signal and interpolating the biopotential to create a digital signal. The limitation of “interpolate across a gap…” is directed to mathematical concepts commonly known and used.
Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claim 18 recites additional elements of “one or more processors”, “a non-transitory computer readable medium”, and “a neurostimulator”.
Step 2A, Prong Two
The above-identified abstract idea in independent Claim 18, and its dependent claims, is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claim 18), 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: “one or more processors” and “a non-transitory computer readable medium” are generically recited computer elements in independent Claim 18 (and the dependent claims) 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 18 (and the dependent claims) 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. “one or more processors” and “a non-transitory computer readable medium” 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 18 (and the dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claim 18 (and the dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claim 18 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: “one or more processors” and “a non-transitory computer readable medium”. 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.
These claims also require: “a neurostimulator”. Per Applicant’s specification: “a neurostimulator” is described in the disclosure as a component that is generic and conventionally used and known in the art as one of many different types of electrical stimulation devices [¶¶ 13, 21 – published app].
Additionally, the claimed terms: “one or more processors” and “a non-transitory computer readable medium” 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 “one or more processors” and “a non-transitory computer readable medium”. 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 18 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 system of Claim 18 (and the dependent claims) 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 18 (and the dependent claims) 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.
As such, claim 18-33 when analyzed as a whole, do not appear to be patent eligible for the reasons set forth above.
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 18-33 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. In claim 18, the phrase “receive a synchronization pulse from an electrical stimulation system…” inferentially includes and functionally recites an electrical stimulation system; however, this element has not been positively set forth or recited in the system and it is unclear whether it is a required and necessary component of the system or not. In addition, claim 18 recites, “wherein the electrical stimulation system comprises a neurostimulator”. As noted above, an electrical stimulation system has not been set forth and cannot be further limited. In order to overcome the rejection, the claim must first recite an electrical stimulation system prior to functionally limiting the element.
Claims 19-33 are rejected under the same rationale as being dependent upon claim 18 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 18-33 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Brockway et al. (US 2016/0022164; hereinafter “Brockway”).
Regarding claim 18, Brockway discloses a denoising system for removing a transitory noise from a digitized biopotential of a living being, said transitory noise generated synchronous with electrical stimulation of a portion of a body of the living being, said system comprising one or more processors configured to, upon execution of instructions stored on a non-transitory computer-readable medium (e.g. Abstract): receive a synchronization pulse signal from an electrical stimulation system indicative of timing of the electrical stimulation (e.g. ¶¶ 129, 154-155), wherein the electrical stimulation system comprises a neurostimulator (e.g. ¶¶ 108); remove said transitory noise from the digitized biopotential based upon receipt of the received synchronization pulse (e.g. ¶¶ 86-88); and interpolate across a gap created in the digitized biopotential to create a digitized biopotential free of transitory noise (e.g. ¶¶ 183-191).
Regarding claim 19, Brockway discloses the digitized biopotential is an ECG waveform (e.g. ¶¶ 158).
Regarding claim 20, Brockway discloses the denoising system comprises one or more switches configured to open and close based on the receipt of the synchronization pulse (e.g. ¶¶ 154-155).
Regarding claim 21, Brockway discloses the one or more processors are further configured to remove values in memory locations corresponding to portions of the digitized biopotential having the transitory noise in order to remove the transitory noise from the digitized biopotential (e.g. ¶¶ 208, 214).
Regarding claim 22, Brockway discloses the one or more processors are configured to replace the removed values with modified values to reconstruct the digitized biopotential as a denoised biopotential in order to interpolate across the gap in the digitized biopotential (e.g. ¶¶ 134).
Regarding claim 23, Brockway discloses the one or more processors are configured to interpolate across the gap created in the digitized biopotential by applying a linear interpolation (e.g. ¶¶ 186).
Regarding claim 24, Brockway discloses the one or more processors are configured to interpolate across the gap created in the digitized biopotential by applying a curvilinear interpolation (e.g. ¶¶ 183-189).
Regarding claim 25, Brockway discloses the one or more processors are configured to interpolate across the gap created in the digitized biopotential by applying a cubic spline interpolation (e.g. ¶¶ 189).
Regarding claim 26, Brockway discloses the one or more processors are further configured to filter out 50 Hz or 60 Hz line frequency components for a time period prior to removing said transitory noise to ensure the first value and the last value are not affected by the 50 Hz line frequency components (e.g. ¶¶ 137, 153, etc.).
Regarding claim 27, Brockway discloses the one or more processors are further configured to refine the digitized bipotential using at least one of a linear phase filter or a digital finite impulse response filter to create a denoised ECG signal (e.g. ¶¶ 61).
Regarding claim 28, Brockway discloses the one or more processors are further configured to: convert the digitized biopotential into an analog signal to facilitate output on a display; and output the digitized biopotential for presentation on the display (e.g. ¶¶ 53).
Regarding claim 29, Brockway discloses a patient monitor comprising the display; and the neurostimulator (e.g. ¶¶ 53).
Regarding claim 30, Brockway discloses the one or more processors are further configured to refine the digitized biopotential using a linear phase filter (e.g. ¶¶ 137).
Regarding claim 31, Brockway discloses the linear phase filter comprises a low pass filter (e.g. ¶¶ 24).
Regarding claim 32, Brockway discloses the linear phase filter comprises a notch filter (e.g. ¶¶ 137).
Regarding claim 33, Brockway discloses the linear phase filter comprises a band pass filter (e.g. ¶¶ 10).
Conclusion
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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