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 filed December 10, 2025 have been fully considered but they are not persuasive.
The Applicant argues that pending claims 67-83 because “the integrate the purported abstract idea into a practical application” (page 10 of Remarks). However, this is not a persuasive argument for the reasons previously made of record. As such, the claims remain rejected under 35 U.S.C. 101 as previously made of record and detailed below.
Additionally, Applicant argues “nowhere does Gozani teach or suggest a processor configured to receive at least one modified stimulation parameter based on the determined dosage” (page 12 of Remarks). However, the examiner respectfully disagrees.
Claim 67 recites “a processor configured to” “receive at least one modified stimulation parameter based on the determined dosage”. Gozani et al. discloses in Figure 5 and paragraphs 70-71, “Pulses of fixed or randomly-varying frequencies are applied throughout the duration of the therapy session 482. The intensity of the stimulation (i.e., the amplitude 493 of the current delivered by TENS stimulator 105) is adjusted in response to user input and for habituation compensation, as will hereinafter be discussed in further detail. In order to deliver consistently comfortable and effective pain relief to a user throughout both the day and the night, it may not be appropriate to deliver a fixed TENS stimulation level, since the effect of circadian or other time-varying rhythms can mitigate the effectiveness of TENS stimulation. Parameters impacting TENS stimulation effectiveness include, but are not limited to, stimulation pulse amplitude 493 and pulse width 494, pulse frequency 495, and therapy session duration 482. By way of example but not limitation, higher amplitude and longer pulses (i.e., larger pulse charges) increase the stimulation delivered to the user (i.e., increase the stimulation “dose”), whereas shorter therapy sessions decrease the stimulation delivered to the user (i.e., decrease the stimulation “dose”). Clinical studies suggest that pulse charge (i.e., pulse amplitude and pulse width) and therapy session duration have the greatest impact on the therapeutic stimulation delivered to the user (i.e., the therapeutic stimulation “dose”)”. As such, Gozani et al. does in fact disclose a processor configured to receive at least one modified stimulation parameter based on the determined dosage of the applied electrical stimulation.
Therefore, for the reasons stated above and previously made of record, the claims remain rejected as detailed below.
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.
Claim 68 is 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 68 recites the limitation "the nerve" in line 2. There is insufficient antecedent basis for this limitation in the 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 67-83 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 67-83 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 Each of claims 67-83 recites at least one step or instruction for training a neural network to generate one or more models of the brain, which is grouped as a Mental Process under the 2019 PEG under the 2019 PEG. Mental Processes are a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “signal generator”; “processor” and “memory”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “signal generator”; “processor” and “memory” language in the context of this claim generating parameters for electrical signals. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Further, dependent claims 68-83 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 each of independent Claim 67 and the respective dependent Claims 68-83 do not integrate into a practical application under 2019 PEG because the additional elements (signal generator, processor, memory, and an electrode), 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: signal generator, processor and memory are generically recited computer elements 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 67 (and the 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) using rules (e.g., computer instructions) executed by a computer (e.g., signal generator, processor and memory 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. 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 67 (and the dependent claims) are not integrated into a practical application under the 2019 PEG. Accordingly, Claims 67-83 are each directed to an abstract idea under 2019 PEG. Step 2B None of Claims 67-83 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: signal generator, processor and memory. 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, 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.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processing device, controller and interface. 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 activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications). The recitation of the above-identified additional limitations in Claims 67-83 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 system and method of Claims 67-83 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 67-83 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 67(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. 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 67-83 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 67-83 amounts to significantly more than the abstract idea itself. Accordingly, they 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.
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.
Claims 67-77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gozani et al. (US 20180177996 A1).
As to claim 67, Gozani et al. discloses an electrical stimulation system (Abstract) comprising: an electrode ([0058]) configured to be coupled to a patient ([0048-0049]); a signal generator (stimulation unit, depicted as 172 in Figure 7; [0048-0053, 0073]) operably coupled to the electrode and configured to generate a set of pulses for transcutaneous electrical stimulation of the patient ([0048-0053]); and a processor (control unit, depicted as 171 in Figure 7; [0048-0053, 0073]) and a memory ([0075, 0077]) coupled to the signal generator, the processor configured to: receive one or more stimulation parameters ([0011, 0087-0088]); apply the electrical stimulation having the received one or more stimulation parameters to a nerve of a patient using the electrode ([0067, 0073]; claims 37 and 45-48 on pages 11-12); determine a dosage of the electrical stimulation applied to the nerve ([0011, 0071, 0087-0088]; claim 37 on pages 11-12); and receive at least one modified stimulation parameter based on the determined dosage ([0011, 0071, 0087-0088]; claim 48 on page 12).
As to claim 68, Gozani et al. discloses determining the dosage comprises calculating an electric charge delivered to the nerve of the patient ([0070-0071]).
As to claim 69, Gozani et al. discloses receiving the one or more stimulation parameters comprises selecting one of a first treatment program having a first set of stimulation parameters and configured to preemptively treat a disorder and a second treatment program having a second set of stimulation parameters and configured to acutely treat the disorder ([0003, 0008-0009, 0070-0071, 0087-0089]; claims 37, 48-49 and 53 on pages 11-12; Figure 5).
As to claim 70, Gozani et al. discloses the processor is configured to receive an increase in a first treatment program session frequency based on the determined dosage and a reduction in a second treatment program session frequency ([0009, 0011, 0070-0071, 0087-0089, 0094]; Figure 5).
As to claim 71, Gozani et al. discloses the processor is configured to receive an increase in the dosage of the first treatment program ([0009, 0011, 0070-0071, 0087-0089, 0094]; Figure 5).
As to claim 72, Gozani et al. discloses the processor is configured to receive a reduction in the dosage of the first treatment program over a predetermined time period after modifying the at least one stimulation parameter ([0009, 0011, 0070-0071, 0087-0089, 0094]; Figure 5; claims 37, 45-49 and 53 on pages 11-12).
As to claim 73, Gozani et al. disclose the processor is configured to receive at least one modified stimulation parameter during one of the first treatment session and the second treatment session ([0009, 0011, 0070-0071, 0087-0089, 0094]; Figure 5; claims 37, 45-49 and 53 on pages 11-12).
As to claim 74, Gozani et al. discloses the processor is configured to generate a third treatment program having a third set of stimulation parameters based on the received at least one modified stimulation parameters during one of the first treatment session and the second treatment session ([0009, 0011, 0070-0071, 0087-0089, 0094]; Figure 5).
As to claim 75, Gozani et al. discloses the processor is configured to receive a selection of the third treatment program ([0009, 0011, 0070-0071, 0087-0089, 0094]; Figure 5).
As to claim 76, Gozani et al. discloses the processor is configured to generate a graphical user interface comprising the determined dosage ([0049-0050, 0054]; Figure 2).
As to claim 77, Gozani et al. discloses the electrical stimulation comprise one or more of a frequency, a current, a pulse width, a pulse amplitude, a dead time, a pulse duration, a session time, a session duration, a maximum current amplitude in a session, and a session frequency ([0070-0071]; Figure 5; claims 24, 34, 48 and 55 on pages 11-12).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 78-83 are rejected under 35 U.S.C. 103 as being unpatentable over Gozani et al. (US 20180177996 A1).
Gozani et al. discloses the invention substantially as claimed but does not explicitly disclose the electrical stimulation parameters being: a frequency of between about 10 Hz and about 300 Hz, a current of between about 1 mA and about 35 mA, a pulse width between about 240 μs and about 260 μs, a pulse amplitude of up to about 17 mA, a dead time of between about 1 μs and about 10 μs, and/or a duration of between about 150 microseconds and about 450 microseconds with a maximum increase in current of up to about 20 mA at a rate of less than or equal to about 40 microamperes per second and with a step up in current not exceeding about 50 microamperes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stimulation parameters of the electrical stimulation signal frequency, current, pulse width, pulse amplitude, dead time and duration of Gozani et al. to be: a frequency of between about 10 Hz and about 300 Hz, a current of between about 1 mA and about 35 mA, a pulse width between about 240 μs and about 260 μs, a pulse amplitude of up to about 17 mA, a dead time of between about 1 μs and about 10 μs, and/or a duration of between about 150 microseconds and about 450 microseconds with a maximum increase in current of up to about 20 mA at a rate of less than or equal to about 40 microamperes per second and with a step up in current not exceeding about 50 microamperes in order to provide the predictable results of optimizing treatment to meet specific patient therapeutic needs and requirements. Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E 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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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796