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 Amendment
This Office Action is responsive to the amendment filed on 22 December 2025. As directed by the amendment: Claims 6, 8, and 13 have been amended, Claims 12 and 14 have been cancelled, and no claims have been added. Claims 1-5 were previously withdrawn due to a Restriction Requirement.
Thus, Claims 6-11 and 13 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“stimulus controller module” in Claims 6, 7, 8, 10
“training processing module” in Claim 6 and 12-13
“communication module” in Claims 6 and 8
“switch control module” and “pulse control module” in Claim 10
These modules will be interpreted as described in the instant application’s Specification/Drawings, which includes the circuitry components which perform these functions (e.g. Paragraph 0039, 0045, 0068, 0071, 0086, 0090, 0094, 0095).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.before the effective filing date of the claimed invention.
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.
Claims 6, 7, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (US Publication No. 2017/0021171, previously cited) in view of Goldwasser et al. (US Publication No. 2014/0148872, previously cited).
Regarding Claim 6, Perez et al. discloses a system comprising: a non-invasive nerve stimulator for peripheral nerves (Abstract, Paragraph 0014, 0023, 0023, 0400, 0412), including ulnar or median nerves (target nerves in the ulnar/median nerve region of the wrist/arm where neural dermatomes C8 and T1 meet, Paragraph 0398, 0577, 0579), to be fitted proximate a left or right arm, wrist, or hand of a user (wearable wrist/hand devices of Figs. 21A-B, 22-A-C, 23, 24, 26), to stimulate the ulnar or median nerves using at least one stimulus (target nerves in the ulnar/median nerve region of the wrist/arm where neural dermatomes C8 and T1 meet, Paragraph 0398, 0577, 0579),
the nerve stimulator comprising: a stimulus generator (116, Fig. 1A, Paragraph 0030, 0036, 0094, 0401, 0650) to generate at least one stimulus; an applicator (110, 118, Fig. 1A) to apply the generated stimulus to the arm, wrist, or hand of the user (wearable wrist/hand devices with nerve stimulator 2118 of Figs. 21A-B, 22-A-C, 23, 24, 26), the applicator comprising at least one stimulus interface (electrodes 118, Fig. 1A, stimulator 2118, Figs. 21A-B, 22-A-C, 23, 24, 26) to apply the at least one stimulus to the user's skin, proximate to an anterior or ventral side of the user's arm, wrist, or hand (wearable wrist/hand devices with nerve stimulator 2118 of Figs. 21A-B, 22-A-C, 23, 24, 26);
at least one user biometric measuring sensor (135, Fig. 1A, Paragraph 0404-0406, Table 1, Table 2) embodied in or proximate the applicator to monitor and determine physiological parameters associated with the user, including any one or more of the following: heart rate (HR), heart rate variability (HRV), temperature, SpO2 (blood oxygen level), GSR (galvanic skin response), and activity (heart rate, beat-to-beat variability, skin/core temp, oxygen consumption/saturation, GSR, accelerometer, Paragraph 0404-0406, Table 1, Table 2),
a controller (120, 112, 105, Fig. 1 A, Paragraph 0392, 0400-0401, 0590, 0780-0781) to control an operation of the stimulus generator and the applicator, the controller including a stimulus controller module configured to control an applied stimulation in accordance with a stimulation profile (Abstract, Paragraph 0107-0108, 0392, 0400-0401, 0590, 0780-0781), the stimulation profile defining the applied stimulus in terms of duration, frequency, intensity, amplitude or width (pulse width, the pulse amplitude, the pulse frequency, the pulse shape, the duty cycle, the session duration, and the session frequency, Paragraph 0108, 0087-0091, 0599),
wherein the stimulus controller module is configured to apply the stimulation profile based on the physiological parameters received from the at least one user biometric measuring sensor (Paragraph 0020, 0023, 0238, 0373, 0401, 0410, 0497, 0599), so as to define a closed loop feedback arrangement (real-time feedback, Paragraph 0020, 0023, 0373, 0401, 0410, 0497, 0599), wherein the stimulus controller module is configured to compare the received physiological parameters to a predetermined level or profile (predetermined parameters for comparison, Paragraph 0408-0410, 0497 0629, 0637, 0639, 0689), and either select an alternative stimulation profile or adjusts the existing stimulation profile being used (Paragraph 0020, 0023, 0373, 0401, 0410, 0497, 0599, 0645);
further wherein the nerve stimulator (Paragraph 0524, 0526, 0528, 0530) is in communication with the training processing module via a communication module (communication between stimulation programming and health monitoring app/system, Paragraph 0023, 0145, 0159, 0213, 0234, 0373, 0410, 0471, 0473, 0475), to facilitate communication and data transfer, which in turn is in communication with the training computer (training/weight loss program/diary widget, e.g. on a smartphone/companion device, Paragraph 0472, 0527-0529, 0532, 0794; Health Management Application, Paragraph 0524-0526),
and a training computer running an interactive computer cognitive training application (training/weight loss program/diary widget, e.g. on a smartphone/companion device, Paragraph 0472, 0527-0529, 0532, 0794; Health Management Application, Paragraph 0524-0526) configured for user interaction (inputting and interacting with training program, Paragraph 0472, 0527-0529, 0532, 0534, 0794; see input screens of Figs. 8-16), the training computer comprising a training processing module which is arranged to be in communication with the nerve stimulator (stimulation based on input parameters and specific training program, Paragraph 0528) to co-ordinate the stimulation of the median or ulnar nerves (Paragraph 0398, 0577, 0579) with cognitive training activities or learning elements (exercise/compliance prompts, food intake modification, encouraging behavior changes, etc. Paragraph 0508, 0530, 0532, 0536, 0547, 0547, 0686; “enables instilling weight management habits in the patients”, Paragraph 0523) that the user must engage with or at predetermined times during cognitive training (push notification/alerts, Paragraph 0514, 0523; real-time integration of all data/activities, Paragraph 0020, 0514, 0495, 0497; patient input at pre-defined times, Paragraph 0036-0039, 0673, 0699, 0702),
wherein the training processing module monitors the user's cognitive performance during the cognitive training (monitoring and inputs in real-time, Paragraph 0472, 0524-0529, 0532, 0534, 0794), and instructs a pulse control module to select an electrical stimulation pulse profile or select another electrical stimulation pulse profile, if one is already being used (selecting stimulation protocol depending on input/monitoring, Paragraph 0020, 0023-0024, 0243, 0370, 0386, 0481, 0483).
However, Perez et al. does not explicitly disclose wherein the interactive computer cognitive training application comprises a language or educational application, which the user must engage with or at predetermined times, during the cognitive training activities or learning elements, wherein the training processing module is further arranged to monitor the user's cognitive performance during the cognitive training activities or learning elements, with the controller further being arranged to select a stimulation pulse profile or select another stimulation profile, as part of the closed loop feedback arrangement.
Goldwasser et al. teaches a system comprising: a non-invasive nerve stimulator (Abstract, Paragraph 0019, 0028; Claim 1), including an interactive computer cognitive training application (cognitive training enhancement application, Paragraph 0019-0027, 0198, 0230) which comprises a language or educational application (language or other learning applications, Paragraph 0019, 0021, 0027, 0162, 0198, 0230; programs on a smartphone/table, Paragraph 0138, 0200), which the user engages with or at predetermined times during the cognitive training activities or learning elements (assigned tasks/assessments, Paragraph 0027, 0138, 0163, 0230),
wherein the training wherein the training processing module is further arranged to monitor the user's cognitive performance duinng the cognitive training activities or
learning elements (real-time feedback based on sensors/input, Paragraph 0175, 0179-0184, 0211-0212, 0215, 0229-0231), with the controller further being arranged to
select a stimulation pulse profile or select another stimulation profile (stimulation protocol, Paragraph 0030, 0205, 0208, 0210, 2016; Claim 2), as part of the closed loop feedback arrangement (real-time feedback based on sensors/input, Paragraph 0175, 0179-0184, 0211-0212, 0215, 0229-0231).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include specifically a language or educational application, and closed-loop feedback selection of a stimulation pulse profile, as taught by Goldwasser et al. in the system disclosed by Perez et al., in order to provide explicitly tailored educational/cognitive training to the specific user for learning enhancement purposes, based on real-time feedback based on sensors/input, as also taught by Goldwasser et al. (Paragraph 0175, 0179-0184, 0211-0212, 0215, 0229-0231).
Regarding Claim 7, Perez et al. discloses the system further wherein the stimulus controller module is configured to continue to monitor the physiological parameters (135, Fig. 1A, Paragraph 0238, 0404-0406, Table 1, Table 2), and once the predetermined level or profile of the physiological parameters is achieved (Paragraph 0020, 0023, 0373, 0401, 0410, 0497, 0599, 0645), yet another stimulation profile may be selected and applied to maintain the predetermined level or profile of the physiological parameters or the stimulation may be stopped (Paragraph 0020, 0023, 0373, 0401, 0410, 0497, 0599, 0645).
Regarding Claim 8, Perez et al. discloses the system further wherein the stimulator includes a communication module (114, Fig. 1A) to facilitate communication and data transfer between the nerve stimulator and an external or remote device (105, Fig. 1A), including a mobile device of the user or a remote server, (Paragraph 0145, 0159, 0234, 0373, 0410, 0471, 0473, 0475) wherein:
the data transferred from the stimulator includes information regarding the stimulus being applied, including duration, frequency, and strength (Paragraph 0234, 0373, 0410, 0471, 0473, 0475, Claim 115) or the physiological parameters determined by the at least one user biometric measuring sensor (Paragraph 0234, 0238, 0373, 0410, 0471, 0473, 0475);
and the data transferred to the stimulator from the external or remote device includes information regarding a variation to the stimulus to be applied (Paragraph 0234, 0238, 0373, 0410, 0471, 0473, 0475), to implement an amended or adjusted stimulation profile (Paragraph 0020, 0023, 0234, 0238, 0373, 0410, 0471, 0473, 0475), which the controller can then implement, via the stimulus controller module (Abstract, Paragraph 0107-0108, 0392, 0400-0401, 0590, 0780-0781), in conjunction with the generator (116, Fig. 1A) and applicator (110, 118, Fig. 1A).
Regarding Claim 13, Perez et al. discloses the system further wherein the training processing module continues to monitor the user's cognitive performance (long term monitoring, with specific examples of 1-3 months, Paragraph 0370, 0422, 0434, 0502, 0507-0509, 0529), and once a required cognitive performance level has been achieved (maintaining health/weight loss with specific stimulation protocol, Paragraph 0014, 0243, 0370, 0386, 0481, 0483), another electrical stimulation pulse profile is selected and applied to maintain the user's performance (maintaining health/weight loss with specific stimulation protocol, Paragraph 0014, 0243, 0370, 0386, 0481, 0483).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (US Publication No. 2017/0021171, previously cited) in view of Goldwasser et al. (US Publication No. 2014/0148872, previously cited), further in view of DiLorenzo (US Publication No. 2006/0116736, previously cited)
Regarding Claim 9, Perez et al. discloses the system further wherein the stimulator comprises at least one or more of a plurality of stimulators (electrodes 118, Fig. 1A, 2118/2200aid, Figs. 22A-D, Paragraph 0581), which are fitted so as to stimulate the user's left arm or wrist or hand, the user's right arm or wrist or hand, or the user's left and right arm or wrist or hand (user's left/right arm, wrist, or hand with wearable wrist/hand devices with nerve stimulator 2118 of Figs. 21A-B, 22-A-D, 23, 24, 26), wherein the at least one stimulus includes electricity (Abstract, Paragraph 0014), light (LEDs, Paragraph 0402), sound (beeper/audio indicator, Paragraph 0402), vibration (vibrator, Paragraph 0402) , or any combination of these stimuli, with the stimulus being MEl 34175173v.1National Stage of PCT/IB2017/053198Docket No.: 127677-00102Preliminary Amendmentapplied either as a continuous waveform, including square (Paragraph 0428), or as a series of pulses (Paragraph 0030, 0088, 0393, 0423).
Perez al. further discloses a nerve stimulator wherein the at least one stimulus includes electricity (Abstract, Paragraph 0014), light including an LED (LEDs, Paragraph 0402), sound including a sound generator (beeper/audio generator, Paragraph 0402), or vibration including a vibration generator (vibrator, Paragraph 0402). However, Perez et al. and Goldwasser et al. in combination does not specifically disclose wherein light stimulus, sound stimulus, vibration stimulus, or pressure stimulus is configured to stimulate the nerves.
DiLorenzo teaches a peripheral nerve stimulator which includes noninvasive light stimulus, sound stimulus, pressure stimulus, or vibration stimulus is configured to stimulate the peripheral nerves (Paragraph 0024, 0095, 0096, 0145-0146). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure light stimulus, sound stimulus, vibration stimulus, or pressure stimulus to stimulate nerves, as taught by DiLorenzo, in the nerve stimulator for peripheral nerves disclosed by Perez et al. and Goldwasser et al. in combination, in order minimize power consumption, to provide a less intensive/painful stimulus to the nerves, and/or to reduce manufacturing costs for the nerve stimulation components.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (US Publication No. 2017/0021171, previously cited) in view of Goldwasser et al. (US Publication No. 2014/0148872, previously cited), further in view of Dilorenzo (US Publication No. 2006/0116736, previously cited), further in view of Glukhovsky et al. (US Publication No. 2010/0198298, previously cited)
Regarding Claim 10, Perez et al. discloses the system further wherein for an electrical stimulus, the stimulus generator (116, Fig. 1A, Paragraph 0030, 0036, 0094, 0401, 0650) is configured to generate the electrical stimulus for application, wherein the electrical stimulus comprises a series of electrical pulses (Paragraph 0030, 0088, 0393, 0423), with the stimulus controller module (Abstract, Paragraph 0107-0108, 0392, 0400-0401, 0590, 0780-0781) including a pulse control module (Paragraph 0030, 0088, 0393, 0423) to control the electrical stimulus in accordance with the stimulation profile, and wherein the stimulus interface (electrodes 118, Fig. 1A, stimulator 2118, Figs. 21A-B, 22-A-C, 23, 24, 26) includes at least one switching arrangement (Paragraph 0402, 0631) to control the operation of the stimulus interface, further wherein a battery and related battery charger (Paragraph 0391, 0401, 0440, 0443, 0455) are connected to each switching arrangement (Paragraph 0402, 0631, 0402, 0631) associated with each stimulus interface (electrodes 118, Fig. 1A, stimulator 2118, Figs. 21A-B, 22-A-C, 23, 24, 26), wherein the stimulus interface includes at least one electrode pair (318, 318’, Fig. 3A, 328, 328’, Fig. 3B, electrodes 118, Fig. 1A) to send current through the user's tissue in order to stimulate the nerves (Paragraph 0428-0429, 0014, 0023, 0023, 0400, 0412), and with the electrode pairs being arranged into a predetermined configuration (305, 310, Figs. 3A-3B, 420, Fig. 4C) to allow targeted stimulation of specific areas of the nervous system (Paragraph 0428-0429, 0014, 0023, 0023, 0400, 0412), with the electrode pair running parallel to each other (318, 318’, Fig. 3A, 328, 328’, Fig. 3B. Paragraph 0428-0429) for targeting ulnar or median nerves in the arm (target nerves in the ulnar/median nerve region of the wrist/arm where neural dermatomes C8 and T1 meet, Paragraph 0398, 0577, 0579), which run alongside the length of the forearm (Paragraph 0398, 0577, 0579).
However, Perez et al., Goldwasser et al., and DiLorenzo in combination do not specifically disclose wherein the stimulus generator includes a high voltage generator and a current limiter to generate the electrical stimulus for application via a switching matrix connected to a switching arrangement, or wherein the stimulus controller module including a switch control module to control switching of the electrical stimulus, via the switching matrix. Glukhovsky et al. teaches an external nerve stimulator system configured to be attached to a subject’s skin (Abstract, Paragraph 0001, 007, 0009, 0075, 0121) comprising a stimulus generator (Abstract, Paragraph 0009, 0075, 0121) including a high voltage generator and a current limiter (high voltage generators, Paragraph 0118, constant current generator, Paragraph 0118, current steering, Paragraph 0153, 0164, current limiter, Claims 4, 21) to generate the electrical stimulus for application via a switching matrix connected to a switching arrangement (Paragraph 0134, 0144, 0160-0161, Claims 12, 36, 23), and wherein the stimulus controller module includes a switch control module (52, 62, Fig. 6, Paragraph 0134, 0144, 0146) (Paragraph 0134, 0144, 0160-0161, Claims 12, 36, 23) to control switching of the electrical stimulus, via the switching matrix (Paragraph 0134, 0144, 0160-0161, Claims 12, 36, 23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the stimulus generator to include a high voltage generator and a current limiter to generate the electrical stimulus for application via a switching matrix connected to a switching arrangement, and to configure the stimulus controller module to include a switch control module to control switching of the electrical stimulus, via the switching matrix, as taught by Glukhovsky et al., in the nerve stimulator for peripheral nerves disclosed by Perez et al., DiLorenzo, and Goldwasser et al. in combination, in order to precisely control the stimulation level and the voltage/current being applied to specific electrodes selected by the stimulus generator and the stimulus controller module, for more accurate nerve targeting.
Furthermore, Perez et al., Goldwasser et al., and DiLorenzo in combination do not specifically disclose wherein at least one electrode pair has a dual function to enable the electrode pair to provide and receive electrical current. However, Glukhovsky et al. teaches an external nerve stimulator system configured to be attached to a subject’s skin (Abstract, Paragraph 0001, 007, 0009, 0075, 0121) comprising a stimulus generator (Abstract, Paragraph 0009, 0075, 0121) wherein at least one electrode pair has a dual function to enable the electrode pair to provide and receive electrical current (anode/cathode configurations, Paragraph 0009-0010, 0017, 0034, 0058). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the electrode pair to have a dual function to enable the electrode pair to provide and receive electrical current, as taught by Glukhovsky et al., in the nerve stimulator for peripheral nerves disclosed by Perez et al., DiLorenzo, and Goldwasser et al. in combination, in order to provide anode/cathode electrodes to provide directed current to specific target areas, while avoiding inadvertent stimulation to other tissue areas.
Regarding Claim 11, Perez et al. further discloses a nerve stimulator wherein the stimulation comprises series of electrical pulses (Paragraph 0030, 0088, 0393, 0423), wherein each stimulation pulse comprises a pulse of a single frequency (Paragraph 0088-0091, 0208), wherein the pulse stimulation profile is in the frequency range of between 1 Hz to 10,000 Hz (Paragraph 0208) or as a specific example, 25-75 Hz (Paragraph 0233), an intensity of between 100 uA to 100 mA (Paragraph 0088-0091, 0208), and a pulse width of between 10 uS to 100 mS (Paragraph 0088-0091).
However, none of Perez et al., Goldwasser et al., DiLorenzo, nor Glukhovsky et al. specifically discloses wherein the pulse stimulation profile is particularly in the frequency range of 0.1 Hz to 1000 Hz, has an intensity of between 100 uA to 10 mA and a pulse width of between 1 uS to 100 mS. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use these specific stimulation profile ranges, in order to optimize modulation of the target nerves to tailor a specific treatment to a patient depending on severity, type of desired effect, or pain tolerance, since 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. It is noted that the limitations in the claim after the “or” clause in Line 5 of Claim 11 are not required, since the first half of the claim is obvious as described above.
Response to Arguments
This Office Action is responsive to the amendments filed with the Response/Amendment filed on 22 December 2025.
The Applicant’s amendments to Claim 8 overcomes the previous 35 USC 112b/pre-AIA second paragraph rejections as made in the previous Non-Final Rejection Office Action mailed 26 June 2025.
Furthermore, the Applicant argues that the claim limitations in Claims 6-8, 10, and 12-14 should not be interpreted under 35 USC 112(f) since, “Applicant respectfully submits that each of the aforementioned claim limitations fails at least prong (C) (i.e., "the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function") of the three-prong test outlined in MPEP § 2181, subsection I.” and that “These limitations sufficiently modify and integrate the claimed "stimulus controller module", "training processing module" and "communication module" elements into the system of claim 6.” (Pages 10-12 of Remarks).
However, the Examiner disagrees with these arguments. Although the limitations do not use the word “means,” however, these limitations are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. The claims do not recite any additional structure that perform the recited function, and the claims do not recite any structural modifiers. Although the Applicant notes that the claims recite “configured to” language, however, these are not structural limitations to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Therefore, these modules will be interpreted as described in the instant application’s Specification/Drawings, which includes the circuitry components which perform these functions (e.g. Paragraph 0039, 0045, 0068, 0071, 0086, 0090, 0094, 0095). Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If the Applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, the Applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Furthermore, the Applicant's arguments filed in the Remarks filed 22 December 2025 with respect to the previous 35 U.S.C. 103 rejections of Claims 6-11 and 13-14 have been fully considered.
The Applicant specifically argues (Pages 12-15 of Remarks) that none of the previously cited Perez et al., Goldwasser, DiLorenzo nor Glukhovsky et al. discloses the newly added limitations of independent Claim 6, particularly “wherein the training processing module is further arranged to monitor the user's cognitive performance during the cognitive training activities or learning elements, and instructs a pulse control module with the controller further being arranged to select a stimulation pulse profile or select another stimulation profile”.
The Applicant specifically argues (Page 13 of Remarks):
Moreover, Perez in view of Goldwasser fails to disclose the recited relationship between the training processing module and the pulse control module as part of a closed-loop feedback arrangement that is operative based on physiological and cognitive performance….Thus, Applicant respectfully submits that Perez in view of Goldwater fails to teach the specific, hierarchical control structure recited in amended claim 6. The alleged combination merely teaches a general approach for making adjustments using a controller. In contrast, amended claim 6 recites a specific and non-obvious architecture requiring, in part, a cognitive training application to actively instruct a pulse control module to select a particular stimulation profile. These limitations of Applicant's invention are not a mere aggregation of features. Indeed, amended claim 6 recites a specific, integrated system in which a cognitive training application selects a particular stimulation profile according to other related limitations of amened claim 6.
However, the Examiner disagrees with these arguments. Perez et al. explicitly discloses wherein the training processing module monitors the user's cognitive performance during the cognitive training (monitoring and inputs in real-time, Paragraph 0472, 0524-0529, 0532, 0534, 0794), and instructs the pulse control module to select an electrical stimulation pulse profile or select another electrical stimulation pulse profile, if one is already being used (selecting stimulation protocol depending on input/monitoring, Paragraph 0020, 0023-0024, 0243, 0370, 0386, 0481, 0483). Furthermore, Goldwasser et al. teaches a system comprising: a non-invasive nerve stimulator (Abstract, Paragraph 0019, 0028; Claim 1), including an interactive computer cognitive training application (cognitive training enhancement application, Paragraph 0019-0027, 0198, 0230) which comprises a language or educational application (language or other learning applications, Paragraph 0019, 0021, 0027, 0162, 0198, 0230; programs on a smartphone/table, Paragraph 0138, 0200), which the user engages with or at predetermined times during the cognitive training activities or learning elements (assigned tasks/assessments, Paragraph 0027, 0138, 0163, 0230), wherein the training wherein the training processing module is arranged
monitor the user's cognitive performance duinng the cognitive training activities or
learning elements (real-time feedback based on sensors/input, Paragraph 0175, 0179-0184, 0211-0212, 0215, 0229-0231), with the controller further being arranged to
select a stimulation pulse profile or select another stimulation profile (stimulation protocol, Paragraph 0030, 0205, 0208, 0210, 2016; Claim 2), as part of the closed loop feedback arrangement (real-time feedback based on sensors/input, Paragraph 0175, 0179-0184, 0211-0212, 0215, 0229-0231).
Therefore, the Examiner maintains that Perez et al. and Goldwasser et al. explicitly disclose these limitations in combination.
In response to the Applicant's arguments that the references fail to show certain features of the invention (Pages 12-13 of Remarks), it is noted that the features upon which applicant relies (i.e., narrow definitions of “cognitive training”, “physiological parameters”, and “language or educational application”) are not recited in the rejected Claim 6. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). These terms are given their broadest reasonable interpretation as explained above, and the Examiner maintains that Perez et al. and Goldwasser et al. explicitly disclose these limitations in combination.
In response to the Applicant’s argument (Pages 13-14 of Remarks) that there is no teaching, suggestion, or motivation to combine the Perez et al. and Goldwasser et al. references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner maintains that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include specifically a language or educational application, and closed-loop feedback selection of a stimulation pulse profile, as taught by Goldwasser et al. in the system disclosed by Perez et al., in order to provide explicitly tailored educational/cognitive training to the specific user for learning enhancement purposes, based on real-time feedback based on sensors/input, as also taught by Goldwasser et al. (Paragraph 0175, 0179-0184, 0211-0212, 0215, 0229-0231), since both Perez et al. and Goldwasser et al. disclose cognitive training systems as described in detail above.
In response to the Applicant's argument (Page 14 of Remarks) that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). It is noted that the Applicant specifically argues (Page 14 of Remarks:
Notwithstanding the above arguments, Applicant further submits that the Office Action's combination of four different prior art references represents an impermissible hindsight reconstruction of the claimed invention. …That is, one of ordinary skill in the art would have no reasonable motivation to combine the physiological monitoring of Perez, the cognitive training feedback of Goldwasser, the alternative stimuli of DiLorenzo, and the specific electrical hardware of Glukhovsky. Should the outstanding rejections under 35 U.S.C. § 103 be maintained (which Applicant disagrees with), Applicant respectfully requests that a subsequent Office Action provide further justification for why a skilled artisan would have been motivated to undertake such a complex integration, and for why that complex integration would necessarily arrive at the specific, hierarchical control architecture recited in amended claim 6.
However, it is noted that independent Claim 6 is only rejected under two references, Perez et al. in view Goldwasser et al., as described in detail above, not four prior art references as the Applicant argues.
With respect to the Applicant’s arguments with respect to Claim 11 (Page 15 of Remarks), the Examiner notes that Perez et al. does disclose a nerve stimulator wherein the stimulation comprises series of electrical pulses (Paragraph 0030, 0088, 0393, 0423), wherein each stimulation pulse comprises a pulse of a single frequency (Paragraph 0088-0091, 0208), wherein the pulse stimulation profile is in the frequency range of between 1 Hz to 10,000 Hz (Paragraph 0208) or as a specific example, 25-75 Hz (Paragraph 0233), an intensity of between 100 uA to 100 mA (Paragraph 0088-0091, 0208), and a pulse width of between 10 uS to 100 mS (Paragraph 0088-0091).
However, the Examiner agrees that none of Perez et al., Goldwasser et al., DiLorenzo, nor Glukhovsky et al. specifically discloses wherein the pulse stimulation profile is particularly in the frequency range of 0.1 Hz to 1000 Hz, has an intensity of between 100 uA to 10 mA and a pulse width of between 1 uS to 100 mS. However, the Examiner maintains that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use these specific stimulation profile ranges, in order to optimize modulation of the target nerves to tailor a specific treatment to a patient depending on severity, type of desired effect, or pain tolerance, since it has been held that where the general conditions of a claim are disclosed in the prior art (as described in detail above), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. It is further noted that the limitations in the claim after the “or” clause in Line 5 of Claim 11 are not required, since the first half of the claim is obvious as described above.
No additional specific arguments were presently specifically with respect to the previous 35 USC 103 rejections of dependent Claims 2-10 and 13, nor specifically with respect to the previously cited DiLorenzo or Glukhovsky et al. references. Therefore, Claims 1-11 and 13 are rejected as described in detail above.
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.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796