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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 3/4/26, amended claim(s) 1-2 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
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: “operative element,” in claim 1, which corresponds to an “electrode” (see para [0046] of Applicant’s specification as originally filed); “a stimulation detection device configured to detect electrical stimulation to a target nerve,” in claim 8, which corresponds to “a return electrode, EMG sensor, a cuff, an endotracheal tube or a camera” (see para [0010] of Applicant’s specification as originally filed); “an indicator configured to confirm delivery of a predefined stimulation pattern to tissue,” in claim 10, which corresponds to “one or more light sources, such as a light emitting diode (LED)” (see para [0071] of Applicant’s specification as originally filed); “a pulse counter configure to count a number of pulses applied,” in claim 11, which corresponds to “an evoked potential sensor” (see para [0087] of Applicant’s specification as originally filed), which also is a term that invokes 35 U.S.C. 112(f) and corresponds to “an accelerometer” or “an electrode” (see para [0087] of Applicant’s specification as originally filed); and “an evoked potential sensor configured to determine generation of an evoked potential from a nerve being stimulated,” in claim 13, which corresponds to “an accelerometer” or “an electrode” (see para [0087] of Applicant’s specification as originally filed).
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For claim 1, the claim language “wherein the burst stimulation comprises a burst pattern optimized to produce specific types of evoked contractions to aid in detectability of nerve function” does not appear to be described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See MPEP 2163.03(V). Here, the claim recites the function of producing specific types of evoked contractions to aid in detectability of nerve function, but the specification fails to sufficiently identify what parameters, attributes, and/or characteristics of the burst stimulation that produce this function/result. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Dependent claim(s) 2-14 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-14 is/are rejected under 35 U.S.C. 112(a).
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(s) 1-14 is/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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
For claim 1, the claim language “the first group time” (line 10) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 1, the claim language “the second group time” (lines 10-11) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
Dependent claim(s) 2-14 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-14 is/are rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim(s) 1, 7-9, and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2016/0158550 to Hou et al. (hereinafter “Hou”)
For claim 1, Hou discloses an electrical stimulation device (Abstract) comprising:
a housing (see where reference numeral “150” points to in Fig. 1);
an operative element (110, which includes 121a-d) (Fig. 1) (para [0037]) extending from the housing (as can be seen in Fig. 1);
a control circuitry (151-158) (Fig. 1) (para [0036]) in communication with the operative element (as can be seen in Fig. 1) (para [0037]), wherein the control circuit comprises a memory (158) (Fig. 1) (para [0036]) comprising instructions (para [036]) that when executed generate pulses of stimulus electrical stimulation that comprises 1) at least first and second groups (first portion of 606 that includes two pulses and second portion of 606 that includes two pulses) (Fig. 6) (para [0085]), each group having a respective group time defined as the time between a first pulse and a last pulse of that group (see Fig. 6) (para [0085]), and ii) a burst stimulation having a burst time defined as the time between the first pulse of the first group and the first pulse of the second group (width of 606 that extends from the first pulse of the first portion of 606 to the first pulse of the second portion of 606 relied upon above), wherein the burst time is greater than each of the first group time and the second group time (see Fig. 6) and wherein the burst stimulation comprises a burst pattern optimized to produce specific types of evoked contractions to aid in detectability of nerve function (para [0063] and [0087]).
For claim 7, Hou further discloses a user interface (168), wherein the control circuit modifies a pattern of the burst stimulation based on input from the user interface (para [0049]-[0050]).
For claim 8, Hou further discloses a stimulation detection device configured to detect electrical stimulation to a target nerve (para [0038] and [0058]).
For claim 9, Hou further discloses wherein the stimulation detection device comprises at least one of a return electrode, EMG sensor, a cuff, an endotracheal tube or a camera (para [0038 and [0058]).
For claim 13, Hou further discloses an evoked potential sensor configured to determine generation of an evoked potential from a nerve being stimulated (para [0038] and [0058]).
For claim 14, Hou further discloses wherein the evoked potential sensor comprises an accelerometer or an electrode (para [0038] and [0058]).
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.
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.
Claim(s) 2-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou.
For claim 2, Hou does not expressly disclose wherein the burst stimulation comprises a frequency and amplitude to induce repeated slow-twitch contractions.
However, Hou does teach that each therapy “may include one or more sets of stimulation parameters of the pulse including pulse amplitude, pulse width, pulse frequency or inter-pulse period, pulse repetition parameter (e.g., number of times for a given pulse to be repeated for respective stimset during execution of program), biphasic pulses, monophasic pulses, etc” (para [0050], that these parameters may be updated in a feedback loop to effectuate a specific result “that inhibit spontaneous action potentials along the slow conduction fibers to no more than a select amount of activity” (see para [0063]), and that such modification may be “based upon inputs from a patient or clinician” (see para [0073]).
It would also have been obvious to a skilled artisan to optimize Hou wherein the burst stimulation comprises a frequency and amplitude to induce repeated slow-twitch contractions given that Hou recognizes that stimulation, frequency, and amplitude are result-effective variables that are capable of optimization to achieve a given result for a patient of inhibiting spontaneous action potentials (see para [0063] of Hou). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). A skilled artisan would have been motivated to make such a modification for the obvious advantage of preventing overexcitation of a nerve, which can suppress issues like epilepsy.
For claim 3, Hou does not expressly disclose wherein the frequency is 1.6 Hz and a stimulus electrical frequency is 16 Hz.
However, Hou does teach that each therapy “may include one or more sets of stimulation parameters of the pulse including pulse amplitude, pulse width, pulse frequency or inter-pulse period, pulse repetition parameter (e.g., number of times for a given pulse to be repeated for respective stimset during execution of program), biphasic pulses, monophasic pulses, etc” (para [0050], that these parameters may be updated in a feedback loop to effectuate a specific result “that inhibit spontaneous action potentials along the slow conduction fibers to no more than a select amount of activity” (see para [0063]), and that such modification may be “based upon inputs from a patient or clinician” (see para [0073]).
It would also have been obvious to a skilled artisan to optimize Hou wherein the frequency is 1.6 Hz and a stimulus electrical frequency is 16 Hz given that Hou recognizes that stimulation, frequency, and amplitude are result-effective variables that are capable of optimization to achieve a given result for a patient of inhibiting spontaneous action potentials (see para [0063] of Hou). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). A skilled artisan would have been motivated to make such a modification for the obvious advantage of preventing overexcitation of a nerve, which can suppress issues like epilepsy.
For claim 4, Hou does not expressly disclose wherein the frequency is 2.7 Hz and a stimulus electrical frequency is 16 Hz.
However, Hou does teach that each therapy “may include one or more sets of stimulation parameters of the pulse including pulse amplitude, pulse width, pulse frequency or inter-pulse period, pulse repetition parameter (e.g., number of times for a given pulse to be repeated for respective stimset during execution of program), biphasic pulses, monophasic pulses, etc” (para [0050], that these parameters may be updated in a feedback loop to effectuate a specific result “that inhibit spontaneous action potentials along the slow conduction fibers to no more than a select amount of activity” (see para [0063]), and that such modification may be “based upon inputs from a patient or clinician” (see para [0073]).
It would also have been obvious to a skilled artisan to optimize Hou wherein the frequency is 2.7 Hz and a stimulus electrical frequency is 16 Hz given that Hou recognizes that stimulation, frequency, and amplitude are result-effective variables that are capable of optimization to achieve a given result for a patient of inhibiting spontaneous action potentials (see para [0063] of Hou). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). A skilled artisan would have been motivated to make such a modification for the obvious advantage of preventing overexcitation of a nerve, which can suppress issues like epilepsy.
For claim 5, Hou does not expressly disclose wherein the frequency is 3.2 Hz and a stimulus electrical frequency is 32 Hz.
However, Hou does teach that each therapy “may include one or more sets of stimulation parameters of the pulse including pulse amplitude, pulse width, pulse frequency or inter-pulse period, pulse repetition parameter (e.g., number of times for a given pulse to be repeated for respective stimset during execution of program), biphasic pulses, monophasic pulses, etc” (para [0050], that these parameters may be updated in a feedback loop to effectuate a specific result “that inhibit spontaneous action potentials along the slow conduction fibers to no more than a select amount of activity” (see para [0063]), and that such modification may be “based upon inputs from a patient or clinician” (see para [0073]).
It would also have been obvious to a skilled artisan to optimize Hou wherein the frequency is 3.2 Hz and a stimulus electrical frequency is 32 Hz given that Hou recognizes that stimulation, frequency, and amplitude are result-effective variables that are capable of optimization to achieve a given result for a patient of inhibiting spontaneous action potentials (see para [0063] of Hou). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). A skilled artisan would have been motivated to make such a modification for the obvious advantage of preventing overexcitation of a nerve, which can suppress issues like epilepsy.
For claim 6, Hou does not expressly disclose wherein the frequency is 4 Hz and a stimulus electrical frequency is 32 Hz.
However, Hou does teach that each therapy “may include one or more sets of stimulation parameters of the pulse including pulse amplitude, pulse width, pulse frequency or inter-pulse period, pulse repetition parameter (e.g., number of times for a given pulse to be repeated for respective stimset during execution of program), biphasic pulses, monophasic pulses, etc” (para [0050], that these parameters may be updated in a feedback loop to effectuate a specific result “that inhibit spontaneous action potentials along the slow conduction fibers to no more than a select amount of activity” (see para [0063]), and that such modification may be “based upon inputs from a patient or clinician” (see para [0073]).
It would also have been obvious to a skilled artisan to optimize Hou wherein the frequency is 4 Hz and a stimulus electrical frequency is 32 Hz given that Hou recognizes that stimulation, frequency, and amplitude are result-effective variables that are capable of optimization to achieve a given result for a patient of inhibiting spontaneous action potentials (see para [0063] of Hou). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). A skilled artisan would have been motivated to make such a modification for the obvious advantage of preventing overexcitation of a nerve, which can suppress issues like epilepsy.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou in view of U.S. Patent Application Publication No. 2011/0060243 to Hausman et al. (hereinafter “Hausman”).
For claim 10, Hou does not expressly disclose an indicator configured to confirm delivery of a predefined stimulation pattern to tissue.
However, Hausman teaches an indicator configured to confirm delivery of a predefined stimulation pattern to tissue (para [0068]).
It would have been obvious to a skilled artisan to modify Hou to include an indicator configured to confirm delivery of a predefined stimulation pattern to tissue, in view of the teachings of Hausman, for the obvious advantage of allowing “the surgeon to confirm that the stimulating tip … is in place, the instrument is turned ON, and that stimulus current is flowing” (see para [0068] of Hausman).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou in view of U.S. Patent No. 3,810,457 to Bottcher et al. (hereinafter “Bottcher”).
For claim 11, Hou appears to further discloses a pulse counter configure to count a number of pulses applied (Examiner’s Note: construed in view of the 112(f) invocation above) (para [0038] and [0058]).
However, in the event a skilled artisan would not understand as such, Bottcher teaches a pulse counter configure to count a number of pulses applied (col. 7, lines 10-21).
It would have been obvious to a skilled artisan to modify Hou to include a pulse counter configure to count a number of pulses applied, in view of the teachings of Bottcher, for the obvious advantage of helping to keep track of the number of pulses that have been delivered to the patient.
For claim 12, Hou appears to further discloses wherein the pulse counter is configured to turn off power when a predetermined number of pulses are detected by the pulse counter (Examiner’s Note: construed in view of the 112(f) invocation above) (para [0038] and [0058]).
However, in the event a skilled artisan would not understand as such, Bottcher teaches wherein the pulse counter is configured to turn off power when a predetermined number of pulses are detected by the pulse counter (i.e., via switch 29, col. 10, lines 10-21) (also see col. 4, lines 20-34).
It would have been obvious to a skilled artisan to modify Hou wherein the pulse counter is configured to turn off power when a predetermined number of pulses are detected by the pulse counter, in view of the teachings of Bottcher, for the obvious advantage of stopping stimulation after enough stimulation pulses have been given to the patient.
Response to Arguments
Applicant’s arguments filed 3/4/26 have been fully considered.
With respect to the claim objections, Applicant’s amendments and arguments are persuasive and this the objections are withdrawn.
With respect to the 112 rejections, Applicant’s amendments and arguments are persuasive and those rejections are withdrawn. However, new grounds of rejection are necessitated based on Applicant’s amendments.
With respect to the 102 rejection(s), Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 3/4/26.
Conclusion
THIS ACTION IS MADE FINAL. 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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791