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 .
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. The “stimulation means” is being interpreted under 112(f) as set forth in the disclosure as an electrode or a coil and their equivalents.
Claim Objections
Claim 9 is objected to because of the following informalities: “the extension of the neurostimulation device” should read --an extension of the neurostimulation device--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 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.
In regards to claims 1 and 13, the phrase “can be limited” is vague. It is unclear whether the conditioning sequency actually does provide the claimed effect(s) or whether the effects are optional (i.e., does “can be” mean that the conditioning sequence actually does affect onset/offset/overshoot response or does this refer to some other scope?). The examiner is interpreting the claim as requiring that the effects “are limited,” but clarification is respectfully requested.
In regards to claim 4, line 3, “can comprise” is vague because it is unclear whether the claim requires the variable parameter or not (i.e., similar to above, does “can comprise” mean it actually comprises this parameter, or some other scope?).
In regards to claim 8, it is unclear whether the stimulation means is adaptable by modification of the design “and” the configuration of a stimulation array, or modification of the design “or” the configuration of a stimulation array.
The remaining claims are rejected by virtue of their dependency.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 and 11-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Waataja et al. (US 2022/0193414, hereinafter “Waataja”).
In regards to claims 1 and 13, Waataja discloses a system for peripheral nerve stimulation (e.g., pars. 0166, 0223), in particular for shaping of the field potentials and/or electric fields and/or second spatial derivatives of the electrical potential parallel and/or non-parallel to the nervous structure (Fig. 1B), comprising
at least one neurostimulation device (e.g., Fig. 1B, element 106, “electrical lead assemblies”) with at least one stimulation means (Fig. 1B, element 212, “electrodes”), and
a control unit (element 104, “neuroregulator”),
wherein the control unit is configured to provide a nerve stimulus to a nervous structure via the neurostimulation device (par. 0165),
wherein the control unit is further configured to provide and apply a conditioning sequence with a least one pulse in advance and/or subsequent to the application of the nerve stimulus via the at least one stimulation means of the neurostimulation device to the nervous structure (Figs. 21 and 32 and pars. 0349, 0486, “eliminate an onset response”; the ramp phase before the steady state of pulses),
wherein the conditioning sequence comprises a frequency ramp and is configured such that an onset response and/or an offset response and/or a neural response overshoot by the neural structure can be limited and deviates from the nerve stimulus with respect to being applied with different inter pulse intervals (Fig. 21, “time between pulses decreasing,” par. 0349, “eliminate an onset response”).
In regards to claim 2, the control unit is configured to provide the conditioning sequence further comprising at least one of the following:
- at least one pre-pulse including a pre-pulse sequence comprising a combination of multiple pre-pulses having same time delays or different time delays than the nerve stimulus;
- the frequency ramp in combination with an amplitude ramp;
- the frequency ramp in combination with the pre-pulse sequence (e.g., Fig. 21 a sequence of pulse width ramp up in combination with frequency ramp, par. 0485);
- at least one pre-pulse sequence in combination with an amplitude ramp;
- a combination with the at least one pre-pulse.
In regards to claim 3, the conditioning sequence is configured to shape the field potentials and/or electric fields and/or second spatial derivatives of the electrical potential parallel and/or non-parallel to the nervous structure (Fig. 1B),
wherein the shaping by the conditioning sequence is individualized for different spatial areas along the extension of the nervous structure (par. 0168) and/or
wherein the shaping by the conditioning sequence is provided on a time dependent basis, in a first spatial direction in a first step and in a second spatial direction in a second step.
In regards to claim 4, the conditioning sequence can comprise at least one variable parameter, to form a ramp function, including the frequency ramp function and an amplitude ramp function (par. 0032, “a ramp up of current/voltage amplitude, or a ramp up of frequency, or a ramp up of pulse widths, or combination thereof at or near initiation of applying the stimulation signal”), wherein pulses of the frequency ramp function are the same amplitude as the nerve stimulus and a frequency of the amplitude ramp function is the same as the nerve stimulus (e.g., Figs. 31 and 32, pars. 0486-0488).
In regards to claim 5, the conditioning sequence, includes a frequency and amplitude ramp function Figs. 31 and 32, pars. 0032, 0486-0488), is configured to deviate from the nerve stimulus with respect to being applied with
- a sinusoidal, monophasic or biphasic waveform,
- different pulse width(s) (Fig. 21, par. 0032),
- different amplitude(s) (Fig. 31, pars. 0486-0488), and/or
- different inter pulse interval(s) (Fig. 32, pars. 0486-0488).
In regards to claim 6, the nerve stimulus sequence is
- a high frequency alternating current being provided to the nervous structure in order to achieve high frequency block of the nervous structure (par. 0035) or
- a low frequency stimulus being provided to the nervous structure (par. 0035).
In regards to claim 7, the neurostimulation device comprises the at least one stimulation means being configurable such that the nerve stimulus provided via the at least one stimulation means is adaptable along the nervous structure (par. 0166, “the first electrodes 212, 212a may be individually placed”).
In regards to claim 8, the at least one stimulation means is adaptable by modification of the design, in particular of the shape, of the neurostimulation device, the configuration of a stimulation array (par. 0166, “the first electrodes 212, 212a may be individually placed”).
In regards to claim 9, the control unit is configured to provide individual stimulation signals to each of a plurality of the stimulation means such that the nerve stimulus as provided to the nervous structure via the plurality of stimulation means can be shaped along the extension of the neurostimulation device (par. 0168, “The neuroregulator 104 is configured to independently and separately deliver a first therapy electrical signal through electrodes 212 and 212′, and deliver a second therapy electrical signal through electrodes 212a and 212a′. The first and second therapy signals can independently be a high frequency signal, a high frequency low duty cycle signal, or a low frequency stimulation signal, or other signals according to the present disclosure”).
In regards to claim 11, the neurostimulation device is an implantable pulse generator or a transcutaneous stimulator device (par. 0051).
In regards to claim 12, a plurality of stimulation means form a stimulation array (Fig. 1B), and wherein the nerve stimulus comprises a nerve stimulus sequence comprising multiple subsequent nerve stimulus pulses (e.g., Figs 20-33; stimulus signal comprising many pulses).
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.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Waataja in view of Block et al. (US 2021/0023374, hereinafter “Block”).
Waataja discloses the essential features of the claimed invention, including a control unit capable of current steering by controlling individual electrodes (par. 0259, “the percutaneous lead 104a is configured with or more than two electrodes to operate in a multipolar operation. The multiple electrodes may be used for electrode positional tuning and/or current steering”), but does not expressly disclose that the control unit is configured to steer the current by applying weighing factors on the stimulation signal. However, Block in the same field of endeavor of neural stimulation teaches providing current steering by applying weighing factors on the stimulation signal (par. 0036, “[t]o better manage determination or adjustments of the amplitude or other stimulation parameters for steering the stimulation or for determining efficacious parameters, information can be obtained from one or more of a variety of sources to produce electrode weights that can be used to modify the determination or adjustments to the amplitude or other stimulation parameters”) to provide the predictable results of effectively tailoring stimulation to a subject (par. 0036). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Waataja by providing current steering by applying weighing factors on the stimulation signal to provide the predictable results of effectively tailoring stimulation to a subject.
Response to Arguments
Applicant’s arguments with respect to the prior art rejections of claim 1-13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In regards to the claim interpretation under 112(f), adding additional function to the means-plus-function limitation does not appear to avoid the previous interpretation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fang et al. (US 2009/0204173) is another example of a stimulator utilizing a frequency ramp.
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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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