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.
Claim Objections
Claim 31 is objected to because of the following informalities:
-Claim 31: In line 2: “each channel” should read “each channel of the group of channels”
-Claim 31: In line 5: “of” should read “of”
Appropriate correction is required.
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:
-‘an input device for obtaining electrical potential data’ in claim 38
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 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 21-39 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.
Claim 21 recites ‘an immediately preceding pulse’ after reciting ‘a sequence of pulses’ making it unclear what pulse is being referred to if the immediately preceding pulse is relative to the first pulse of the ‘sequence of pulses’ given there are no other pulses. For examination purposes it will be interpreted as if the preceding pulses are part of the sequence of pulses.
Claim 21 recites the limitation "the delivery" in Line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the same" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the delivery" in Line 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the same" in Line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the delivery" in Line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation "the delivery" in Line 7-8. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 limitation “input device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. No structure is provided in the figures or disclosure concerning what the input device is. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 38 recites the limitation "the at least one data processor" in Lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending to recite ‘the at least one processor’.
Claim 38 recites ‘tissue’ after reciting ‘the patient’s tissue’ making it unclear if ‘tissue’ is meant to refer to ‘the patient’s tissue’ or not. For examination purposes they will be treated as ‘the patient’s tissue’.
Claim 38 recites ‘an immediately preceding pulse’ after reciting ‘a sequence of pulses’ making it unclear what pulse is being referred to if the immediately preceding pulse is relative to the first pulse of the ‘sequence of pulses’ given there are no other pulses. For examination purposes it will be interpreted as if the preceding pulses are part of the sequence of pulses.
Claim 38 recites the limitation "the delivery" in Line 18. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 21 and 23-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farquhar (US 2008/0167574) in view of Zanella (US 2006/0052845) and Kothe et al. (US 2016/0113587).
Regarding claim 21, Farquhar teaches a method for determining a stimulation threshold current level to avoid tetany associated with one or more muscles (Abstract), the method comprising:
causing, by a stimulation system comprising one or more data processors (Figure 10; element 42; control unit), stimulation, via one or more electrodes (Figure 10; element 54; stimulation electrodes), of tissue of a patient as a sequence of pulses delivered at a current level and a frequency (Paragraph 0070 and Figure 3; the figure shows that MEP is performed with a stimulation current level and multiple pulses over a segment of time is a frequency of pulses), the causing including increasing the current level of each pulse in the sequence of pulses from an immediately preceding pulse by a first current increment (Paragraph 0050 and Figures 7A-7C; the stimulation current is doubled with each successive stimulation, which includes a first current level increase, until a significant EMG response is finally evoked);
determining, by the stimulation system, that a first evocation pulse from the sequence of pulses evokes a first muscular response (Paragraph 0050 an EMG response is evoked), the first evocation pulse reaching predetermined criteria, the first evocation pulse having a first evocation current level (Paragraph 0007 the significant EMG response threshold is predetermined),
causing, by the stimulation system, stimulation, via the one or more electrodes, of the tissue with a second evocation pulse from the sequence of pulses to evoke a second muscular response (Paragraph 0070 and Figure 3; the figure shows that MEP is performed with a stimulation current level and multiple pulses over a segment of time is a frequency of pulses), the causing comprising:
maintaining the current level of one or more pulses in the sequence of pulses at the current level of the first evocation pulse or increasing the current level of one or more pulses in the sequence of pulses from the immediately preceding pulse by a second current increment (Paragraph 0050 and Figure 7B; after the first response is found the range between pulses where it exists is repeatedly bracketed and bisected and the current level is increased by an increment until the threshold is found);
determining, by the stimulation system, that the second evocation pulse from the sequence of pulses evokes the second muscular response (Paragraph 0050 it is determined whether the stimulation threshold is reached in each bracket by a significant EMG response); and
storing, by the stimulation system, based at least in part on the determination that the first evocation pulse evokes the first muscular response and the determination that the second evocation pulse evokes the second muscular response, the first evocation current level as the stimulation threshold current level (Paragraph 0062 the stimulation level is saved in order to be displayed to the user).
However, Farquhar is silent on the stimulating comprising maintaining or decreasing the frequency of the delivery of each pulse in the sequence of pulses. Zanella teaches a method of electro-stimulation with experimental results that have shown that the sudden decrease in the pulse frequency applied to the muscle allows the muscle to relax (Paragraph 0050). Zanella further teaches that to reinforce the positive effects of the decrease in frequency, it is possible to repeat a sequence several times, in which case the frequency discontinuity occurs a greater number of times (Paragraph 0050 and Figure 1). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Farquhar to include decreasing the frequency of each pulse in a sequence of pulses as taught by Zanella as a combination of known prior art elements in the same field of muscular electrostimulation to yield the predictable result of allowing the muscle to relax (Paragraph 0050 of Zanella).
Farquhar is silent on the classifying of the evoked response. Kothe teaches the first muscular response comprising a first evoked response that is processed by the stimulation system to classify the first evoked response (Paragraph 0029; ‘For example, the binary classification criterion can include a data-dependent or empirically estimated parameter or parameters, in which the parameter or parameters provide a soft or hard threshold to classify the signal components.’);
the second muscular response comprising a second evoked response that is processed by the stimulation system to compare the first evoked response to the second evoked response (Paragraph 0029; multiple components being compared and classified together);
It would have been obvious to one of ordinary skill in the art to have modified Farquhar with Kothe to better distinguish between artifacts and non-artifact components (Paragraph 0029 of Kothe).
Regarding claim 23, Farquahar teaches wherein the second current increment (Paragraph 0050 and Figure 7B; bisecting the range of 12-16mA results in an increment of 2mA) is the same as the first current increment (Paragraph 0050 and Figure 7B; the current is first incremented from 2-4 mA during the doubling stage which is an increment of 2mA)
Regarding claim 24, Farquahar teaches wherein the determining that the first evocation pulse from the sequence of pulses evokes the first muscular response further comprises: storing the first evocation current level of the first evocation pulse (Paragraph 0062 the stimulation level is saved in order to be displayed to the user).
Regarding claim 25, Farquahar teaches wherein the determining that the first evocation pulse evokes the first muscular response includes receiving, by the stimulation system, a first signal representing the first muscular response (Paragraphs 0044-0047 the Vpp of the EMG response during the first stimulation phase with its associated current level Ithresh) and the determining that the second evocation pulse evokes the second muscular response includes receiving, by the stimulation system, a second signal representing the second muscular response (Paragraphs 0044-0047 the Vpp of the EMG response during the bracketing and bisecting phase and its associated current level Ithresh).
Regarding claim 26, Farquahar teaches further comprising:
comparing, by the stimulation system, the first signal to the second signal (Paragraphs 0044-0047 the signals are compared to each other based on Ithresh);
determining, by the stimulation system, that the first signal can be repeatably obtained-based on the comparison between the first signal and the second signal (Paragraph 0050 and Figure 7C; when the threshold is 8.5 the first signal is repeated in that it evokes a response when the first bisecting current is applied at 12mA); and
displaying, by the stimulation system, the first evocation current level of the first evocation pulse (Paragraph 0062 stimulation levels are displayed).
Regarding claim 27, Farquahar teaches wherein the first signal and the second signal are compared as a group of signals that includes a third signal representing a third muscular response evoked in response to a third evocation pulse (Paragraph 0050 and Figure 7B; the response in the example of the figure is evoked three times to identify the threshold).
Regarding claim 28, Farquahar teaches further comprising:
comparing, by the stimulation system, the first signal to the second signal (Paragraphs 0044-0047 the signals are compared to each other based on Ithresh);
determining, by the stimulation system, that the first signal is not repeatably obtained based on the comparison between the first signal and the second signal (Paragraph 0050 and Figure 7B; when the threshold is 12.5mA the first signal is not repeated in that it does not response when the first bisecting current is applied at 12mA);
causing, by the stimulation system, stimulation of the tissue with a third evocation pulse from the sequence of pulses to evoke a third muscular response (Paragraph 0050 the bracketing continues to narrow down the size of brackets to identify the threshold level), the causing comprising:
increasing, by the stimulation system, the current level of each pulse in the sequence of pulses from the immediately preceding pulse or maintaining the current level of each pulse in the sequence of pulses from the immediately preceding pulse (Paragraph 0050 and Figure 7B; after the first response is found the range between pulses where it exists is repeatedly bracketed and bisected and the current level is increased by an increment until the threshold is found); and
However, Farquhar is silent on the stimulating comprising the stimulating comprising increasing, by the stimulation system, the frequency of the delivery of each pulse in the sequence of pulses. Zanella teaches a method of electro-stimulation that modulates the stimulus frequency, width, and intensity in order to elicit a desired biochemical effect on the cells (Paragraph 0047). In this method, Zanella gradually increases the frequency of the applied signal until a desired point and then drops the frequency thereafter to relax the muscle (Paragraph 0048). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Farquhar to include increasing the frequency of the applied signal as taught by Zanella as a combination of known prior art elements in the same field of muscular electrical stimulation to yield the predictable result of eliciting a desired biochemical response (Paragraph 0048 of Zanella).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farquhar (US 2008/0167574) in view of Zanella (US 2006/0052845) and Kothe et al. (US 2016/0113587) and in further view of Chakravarthy et al. (US 2011/0295142).
Regarding claim 22, Farquhar is silent on further comprising determining, by the stimulation system, that the first evocation pulse and the second evocation pulse are not due to artifact noise present within a first signal representing the first muscular response and artifact noise present within a second signal representing the second muscular response.
Chakravarthy teaches a method of identifying physiological artifacts from physiological signals, including EMG signals (Paragraph 0015), further comprising determining, by the stimulation system, that the first evocation pulse and the second evocation pulse are not due to artifact noise present within a first signal representing the first muscular response and artifact noise present within a second signal representing the second muscular response (Figure 4 step 46). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Farquhar in view of Zanella to include determining whether the evocation pulses are due to artifact noise as taught by Chakravarthy as a combination of known prior art elements in the same field of EMG signal processing to yield the predictable result of evaluating the accuracy of an EMG signal (Paragraph 0015; of Charkravarthy).
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farquhar (US 2008/0167574) in view of Kothe et al. (US 2016/011358 Zanella (US 2006/0052845) 7) and in further view of Rea (US 2012/0150063).
Regarding claim 29, Farquhar is silent on the filtering technique/mathematical transform. Rea teaches wherein the processing of the first evoked response comprises preprocessing the first evoked response using one or more filtering techniques or mathematical transforms (Paragraph 0076; filtering through comparison to baseline signal). It would have been obvious to one of ordinary skill in the art to have modified Farquhar with Rea because it helps to filter out noise from the desired signal (Paragraph 0076 of Rea).
Regarding claim 30, Farquhar is silent on the filtering technique/mathematical transform. Rea teaches wherein the processing of the second evoked response comprises preprocessing the first evoked response using one or more filtering techniques or mathematical transforms (Paragraph 0076; filtering through comparison to baseline signal). It would have been obvious to one of ordinary skill in the art to have modified Farquhar with Rea because it helps to filter out noise from the desired signal (Paragraph 0076 of Rea).
Claim(s) 31 and 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farquhar (US 2008/0167574) in view of Kothe et al. (US 2016/0113587).
Regarding claim 31, Farquahar teaches a method for determining a stimulation threshold current level in a group of channels of a neuromonitoring device, wherein each channel is associated with one or more muscles (Abstract), the method comprising:
causing, by a stimulation system comprising one or more data processors (Figure 10 element 42; control unit), stimulation, via one or more electrodes (Figure 10 element 54; stimulation electrodes), of tissue within a predetermined range of current levels as a sequence of pulses delivered at a frequency by delivering stimulation signals (Paragraph 0070 and Figure 3; the figure shows that MEP is performed with a stimulation current level and multiple pulses over a segment of time is a frequency of pulses), the sequence of pulses including:
a first pulse delivered at a first current level within the predetermined range of current levels (Paragraph 0050 and Figures 7A-7C; any of the pulses during the initial doubling phase that do note evoke a response is a first pulse within a predetermined range); and
a second pulse delivered at a second current level within the predetermined range of current levels (Paragraph 0050 and Figures 7A-7C; the final pulse during the doubling phase where a response is evoked), the first pulse being delivered immediately preceding the second pulse (Paragraph 0050 and Figures 7A-7C; there is a first pulse immediately preceding the final pulse), and the second current level being higher than the first current level (Paragraph 0050 the current level is doubled resulting in a higher current level);
determining that the second pulse evokes a first muscular response (Paragraph 0050 an EMG response is evoked),
causing, by the stimulation system, stimulation, via the one or more electrodes, the tissue with a third pulse from the sequence of pulses to evoke a second muscular response (Paragraph 0050 and Figures 7A-7C; the bracketing phase includes a third pulse), the third pulse being delivered at a third current level that is the same as or higher than the second current level (Paragraph 0050 and Figures 7A-7C; the current level during bracketing will be higher than the initial pulse current level for the bracket);
determining that the third pulse evokes the second muscular response (Paragraph 0050 and Figures 7A-7C; the stimulation is continued and repeatedly triggers the threshold for response until the current level range containing the threshold is sufficiently narrowed); and
storing, by the stimulation system, based at least in part on the determination that the second pulse evokes the first muscular response and the determination that the third pulse evokes the second muscular response, the second current level as the stimulation threshold current level (Paragraph 0062 the stimulation level is saved in order to be displayed to the user).
Farquhar is silent on the classifying of the evoked response. Kothe teaches the first muscular response comprising a first evoked response that is processed by the stimulation system to classify the first evoked response (Paragraph 0029; ‘For example, the binary classification criterion can include a data-dependent or empirically estimated parameter or parameters, in which the parameter or parameters provide a soft or hard threshold to classify the signal components.’).
It would have been obvious to one of ordinary skill in the art to have modified Farquhar with Kothe to better distinguish between artifacts and non-artifact components (Paragraph 0029 of Kothe).
Regarding claim 34, Farquhar teaches wherein the determining that the second pulse evokes the first muscular response includes receiving, by the stimulation system, a first signal representing the first muscular response (Paragraphs 0044- 0047 the Vpp of the EMG response during the first stimulation phase with its associated current level Ithresh) and the determining that the third pulse evokes the second muscular response includes receiving by the stimulation system, a second signal representing the second muscular response (Paragraphs 0044- 0047 the Vpp of the EMG response during the bracketing and bisecting phase and its associated current level Ithresh).
Regarding claim 35, Farquhar teaches further comprising:
comparing, by the stimulation system, the first signal with the second signal (Paragraphs 0044-0047 the signals are compared to each other based on Ithresh);
determining, by the stimulation system, that the first signal can be repeatably obtained-based on the comparison between the first signal and the second signal (Paragraph 0050 and Figure 7C; when the threshold is 8.5 the first signal is repeated in that it evokes a response when the first bisecting current is applied at 12mA); and
displaying, by the stimulation system, the second current level of the second pulse (Paragraph 0062 stimulation levels are displayed).
Regarding claim 36, Farquhar teaches wherein the first signal and the second signal are compared as a group of signals that includes a third signal representing a third muscular response evoked in response to a third evocation pulse (Paragraph 0050 and Figure 7B; the response in the example of the figure is evoked three times to identify the threshold).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farquhar (US 2008/0167574) in view of Kothe et al. (US 2016/0113587) and in further view of Chakravarthy et al. (US 2011/0295142).
Regarding claim 32, Farquhar is silent on further comprising determining, by the stimulation system, that the first pulse and the second pulse are not due to artifact noise present within a first signal representing the first muscular response and artifact noise present within a second signal representing the second muscular response.
Chakravarthy teaches a method of identifying physiological artifacts from physiological signals, including EMG signals (Paragraph 0015), further comprising determining, by the stimulation system, that the first pulse and the second pulse are not due to artifact noise present within a first signal representing the first muscular response and artifact noise present within a second signal representing the second muscular response (Figure 4 step 46). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Farquhar to include determining whether the evocation pulses are due to artifact noise as taught by Chakravarthy as a combination of known prior art elements in the same field of EMG signal processing to yield the predictable result of evaluating the accuracy of an EMG signal (Paragraph 0015 of Chakravarthy).
Claim(s) 33 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farquhar (US 2008/0167574) in view of Kothe et al. (US 2016/0113587) and in further view of Zanella (US 2006/0052845).
Regarding claim 33, Farquahar teaches wherein the stimulating further comprises:
increasing, by the stimulation system, the current level of the third pulse by an amount that is greater than a difference between the first current level and the second current level (Paragraph 0050 and Figure 7B; after the first response is found the range between pulses where it exists is repeatedly bracketed and bisected and the current level is increased by an increment until the threshold is found).
Farquhar is silent on decreasing or maintaining, by the stimulation system, the frequency of the delivery of each pulse in the sequence of pulses; and
Zanella teaches a method of electro-stimulation with experimental results that have shown that the sudden decrease in the pulse frequency applied to the muscle allows the muscle to relax (Paragraph 0050). Zanella further teaches that to reinforce the positive effects of the decrease in frequency, it is possible to repeat a sequence several times, in which case the frequency discontinuity occurs a greater number of times (Paragraph 0050 and Figure 1). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Farquhar to include decreasing the frequency of each pulse in a sequence of pulses as taught by Zanella as a combination of known prior art elements in the same field of muscular electrostimulation to yield the predictable result of allowing the muscle to relax (Paragraph 0050 of Zanella).
Regarding claim 37, Farquhar teaches further comprising:
comparing, by the stimulation system, the first signal with the second signal (Paragraphs 0044-0047 the signals are compared to each other based on Ithresh);
determining, by the stimulation system, that the first signal is not repeatably obtained based on the comparison between the first signal and the second signal (Paragraph 0050 and fig 7B; when the threshold is 12.5mA the first signal is not repeated in that it does not response when the first bisecting current is applied at 12mA);
causing, by the stimulation system, stimulation of the tissue with a fourth pulse from the sequence of pulses to evoke a third muscular response (Paragraph 0050 the bracketing continues to narrow down the size of brackets to identify the threshold level), the causing comprising:
increasing, by the stimulation system, the current level of each pulse in the sequence of pulses from the immediately preceding pulse or maintaining the current level of each pulse in the sequence of pulses from the immediately preceding pulse (Paragraph 0050 and Figure 7B; after the first response is found the range between pulses where it exists is repeatedly bracketed and bisected and the current level is increased by an increment until the threshold is found).
Farquhar is silent on increasing or maintaining, by the stimulation system, the frequency of the delivery of each pulse in the sequence of pulses;
Zanella teaches a method of electro-stimulation that modulates the stimulus frequency, width, and intensity in order to elicit a desired biochemical effect on the cells (Paragraph 0047). In this method, Zanella gradually increases the frequency of the applied signal until a desired point and then drops the frequency thereafter to relax the muscle (Paragraph 0048). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Farquhar to include increasing the frequency of the applied signal as taught by Zanella as a combination of known prior art elements in the same field of muscular electrical stimulation to yield the predictable result of eliciting a desired biochemical response (Paragraph 0048 of Zanella).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farquhar (US 2008/0167574) in view of Zanella (US 2006/0052845).
Regarding claim 38, Farquhar teaches stimulation system for detecting and identifying a stimulation threshold to avoid tetany of a patient's muscles (Abstract), wherein the system comprises:
an input device for obtaining electrical potential data from the patient's physiological system after application of stimulation to the patient's tissue (Paragraph 0060 and Figure 10 element 48; EMG harness);
at least one processor (Paragraph 0061 and Figure 10 element 42; the control unit contains essential processing capabilities); and at least one memory storing instructions (Paragraph 0061 the base of the control unit stores software) which, when executed by the at least one data processor, result in operations comprising:
causing, by the stimulation system (Figure 10 element 42; control unit), stimulation, via one or more electrodes (Figure 10 element 54; stimulation electrodes), of tissue with a sequence of pulses delivered at a current level and a frequency (Paragraph 0070 and Figure 3; the figure shows that MEP is performed with a stimulation current level and multiple pulses over a segment of time is a frequency of pulses), the causing including increasing the current level of each pulse in the sequence of pulses from an immediately preceding pulse (Paragraph 0050 and Figures 7A-7C; the stimulation current is doubled with each successive stimulation, which includes a first current level increase, until a significant EMG response is finally evoked);
determining, by the stimulation system, that a first evocation pulse from the sequence of pulses evokes a first muscular response, the first evocation pulse having a first evocation current level (Paragraph 0050 an EMG response is evoked);
continuing to cause, by the stimulation system, stimulation of the tissue with a second evocation pulse from the sequence of pulses to evoke a second muscular response (Paragraph 0070 and Figure 3; the figure shows that MEP is performed with a stimulation current level and multiple pulses over a segment of time is a frequency of pulses), the causing comprising:
determining, by the stimulation system, that the second evocation pulse from the sequence of pulses evokes the second muscular response (Paragraph 0050 it is determined whether the stimulation threshold is reached in each bracket by a significant EMG response); and
storing, by the stimulation system, based at least in part on the determination that the first evocation pulse evokes the first muscular response and the determination that the second evocation pulse evokes the second muscular response, the first evocation current level as the stimulation threshold current level (Paragraph 0062 the stimulation level is saved in order to be displayed to the user).
However, Farquhar is silent on the stimulating comprising maintaining or decreasing the frequency of the delivery of each pulse in the sequence of pulses; and maintaining or increasing the current level of each pulse in the sequence of pulses from the immediately preceding pulse by a second current increment. Zanella teaches a method of electro-stimulation with experimental results that have shown that the sudden decrease in the pulse frequency applied to the muscle allows the muscle to relax (Paragraph 0050). Zanella further teaches that to reinforce the positive effects of the decrease in frequency, it is possible to repeat a sequence several times, in which case the frequency discontinuity occurs a greater number of times (Paragraph 0050 and Figure 1). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the operations of Farquhar to include decreasing the frequency of each pulse in a sequence of pulses as taught by Zanella as a combination of known prior art elements in the same field of muscular electrostimulation to yield the predictable result of allowing the muscle to relax (Paragraph 0050 of Zanella).
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farquhar (US 2008/0167574) in view of Zanella (US 2006/0052845) and in further view of Chakravarthy et al. (US 2011/0295142).
Regarding claim 39, Farquhar is silent on wherein the operations further comprise determining, by the stimulation system, that the first evocation pulse and the second evocation pulse are not due to artifact noise present within a first signal representing the first muscular response and artifact noise present within a second signal representing the second muscular response.
Chakravarthy teaches a method of identifying physiological artifacts from physiological signals, including EMG signals (Paragraph 0015), comprise determining, by the stimulation system, that the first evocation pulse and the second evocation pulse are not due to artifact noise present within a first signal representing the first muscular response and artifact noise present within a second signal representing the second muscular response (Figure 4 step 46). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Farquhar in view of Zanella to include determining whether the evocation pulses are due to artifact noise as taught by Chakravarthy as a combination of known prior art elements in the same field of EMG signal processing to yield the predictable result of evaluating the accuracy of an EMG signal (Paragraph 0015 of Chakravarthy).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 21-39 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11701047. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application 18/352,975
Conflicting US Patent No. 11701047
21. (New) A method for determining a stimulation threshold current level to avoid tetany associated with one or more muscles, the method comprising:
causing, by a stimulation system comprising one or more data processors, stimulation, via one or more electrodes, of tissue of a patient as a sequence of pulses delivered at a current level and a frequency, the causing including increasing the current level of each pulse in the sequence of pulses from an immediately preceding pulse by a first current increment;
determining, by the stimulation system, that a first evocation pulse from the sequence of pulses evokes a first muscular response, the first evocation pulse reaching predetermined criteria, the first evocation pulse having a first evocation current level, the first muscular response comprising a first evoked response that is processed by the stimulation system to classify the first evoked response;
causing, by the stimulation system, stimulation, via the one or more electrodes, of the tissue with a second evocation pulse from the sequence of pulses to evoke a second muscular response, the causing comprising: maintaining or decreasing the frequency of the delivery of each pulse in the sequence of pulses; and maintaining the current level of one or more pulses in the sequence of pulses at the current level of the first evocation pulse or increasing the current level of one or more pulses in the sequence of pulses from the immediately preceding pulse by a second current increment;
determining, by the stimulation system, that the second evocation pulse from the sequence of pulses evokes the second muscular response, the second muscular response comprising a second evoked response that is processed by the stimulation system to compare the first evoked response to the second evoked response; and
storing, by the stimulation system, based at least in part on the determination that the first evocation pulse evokes the first muscular response and the determination that the second evocation pulse evokes the second muscular response, the first evocation current level as the stimulation threshold current level.
1. A method for determining a stimulation threshold current level to avoid tetany associated with one or more muscles, the method comprising:
causing, by a stimulation system comprising one or more data processors, stimulation, via one or more electrodes, of tissue of a patient as a sequence of pulses delivered at a current level and a frequency, the causing including increasing the current level of each pulse in the sequence of pulses from an immediately preceding pulse by a first current increment;
determining, by the stimulation system, that a first evocation pulse from the sequence of pulses evokes a first muscular response, the first evocation pulse reaching predetermined criteria, the first evocation pulse having a first evocation current level, the first muscular response comprising a first evoked response that is processed by the stimulation system to classify the first evoked response;
causing, by the stimulation system, stimulation, via the one or more electrodes, the tissue with a second evocation pulse from the sequence of pulses to evoke a second muscular response, the causing comprising: decreasing the frequency of the delivery of each pulse in the sequence of pulses; and increasing the current level of one or more pulses in the sequence of pulses from the immediately preceding pulse by a second current increment;
determining, by the stimulation system, that the second evocation pulse from the sequence of pulses evokes the second muscular response, the second muscular response comprising a second evoked response that is processed by the stimulation system to compare the first evoked response to the second evoked response;
wherein the second evocation pulse has a second evocation current level that is greater than the first evocation current level; and
storing, by the stimulation system, based at least in part on the determination that the first evocation pulse evokes the first muscular response and the determination that the second evocation pulse evokes the second muscular response, the first evocation current level as the stimulation threshold current level.
31. (New) A method for determining a stimulation threshold current level in a group of channels of a neuromonitoring device, wherein each channel is associated with one or more muscles, the method comprising:
causing, by a stimulation system comprising one or more data processors, stimulation, via one or more electrodes, of tissue within a predetermined range of current levels as a sequence of pulses delivered at a frequency by delivering stimulation signals, the sequence of pulses including:
a first pulse delivered at a first current level within the predetermined range of current levels; and
a second pulse delivered at a second current level within the predetermined range of current levels, the first pulse being delivered immediately preceding the second pulse, and the second current level being higher than the first current level;
determining that the second pulse evokes a first muscular response, the first muscular response comprising a first evoked response that is processed by the stimulation system to classify the first evoked response;
causing, by the stimulation system, stimulation, via the one or more electrodes, the tissue with a third pulse from the sequence of pulses to evoke a second muscular response, the third pulse being delivered at a third current level that is the same as or higher than the second current level;
determining that the third pulse evokes the second muscular response; and
storing, by the stimulation system, based at least in part on the determination that the second pulse evokes the first muscular response and the determination that the third pulse evokes the second muscular response, the second current level as the stimulation threshold current level.
11. A method for determining a stimulation threshold current level in a group of channels of a neuromonitoring device, wherein each channel is associated with one or more muscles, the method comprising:
causing, by a stimulation system comprising one or more data processors, stimulation, via one or more electrodes, of tissue within a predetermined range of current levels as a sequence of pulses delivered at a frequency by delivering stimulation signals, the sequence of pulses including:
a first pulse delivered at a first current level within the predetermined range of current levels; and
a second pulse delivered at a second current level within the predetermined range of current levels, the first pulse being delivered immediately preceding the second pulse, and the second current level being higher than the first current level;
determining that the second pulse evokes a first muscular response, the first muscular response comprising a first evoked response that is processed by the stimulation system to classify the first evoked response;
causing, by the stimulation system, stimulation, via the one or more electrodes, the tissue with a third pulse from the sequence of pulses to evoke a second muscular response, the third pulse being delivered at a third current level that is higher than the second current level;
determining that the third pulse evokes the second muscular response; and
storing, by the stimulation system, based at least in part on the determination that the second pulse evokes the first muscular response and the determination that the third pulse evokes the second muscular response, the second current level as the stimulation threshold current level.
38. (New) A stimulation system for detecting and identifying a stimulation threshold to avoid tetany of a patient's muscles, wherein the system comprises:
an input device for obtaining electrical potential data from the patient's physiological system after application of stimulation to the patient's tissue; at least one processor; and at least one memory storing instructions which, when executed by the at least one data processor, result in operations comprising:
causing, by the stimulation system, stimulation, via one or more electrodes, of tissue with a sequence of pulses delivered at a current level and a frequency, the causing including increasing the current level of each pulse in the sequence of pulses from an immediately preceding pulse;
determining, by the stimulation system, that a first evocation pulse from the sequence of pulses evokes a first muscular response, the first evocation pulse having a first evocation current level;
continuing to cause, by the stimulation system, stimulation of the tissue with a second evocation pulse from the sequence of pulses to evoke a second muscular response, the causing comprising:
maintaining or decreasing the frequency of the delivery of each pulse in the sequence of pulses; and
maintaining or increasing the current level of each pulse in the sequence of pulses from the immediately preceding pulse by a second current increment;
determining, by the stimulation system, that the second evocation pulse from the sequence of pulses evokes the second muscular response; and
storing, by the stimulation system, based at least in part on the determination that the first evocation pulse evokes the first muscular response and the determination that the second evocation pulse evokes the second muscular response, the first evocation current level as the stimulation threshold current level.
18. A stimulation system for detecting and identifying a stimulation threshold to avoid tetany of a patient's muscles, wherein the system comprises:
an input device for obtaining electrical potential data from the patient's physiological system after application of stimulation to the patient's tissue; at least one processor; and at least one memory storing instructions which, when executed by the at least one data processor, result in operations comprising:
causing, by the stimulation system, stimulation, via one or more electrodes, of tissue with a sequence of pulses delivered at a current level and a frequency, the causing including increasing the current level of each pulse in the sequence of pulses from an immediately preceding pulse;
determining, by the stimulation system, that a first evocation pulse from the sequence of pulses evokes a first muscular response, the first evocation pulse having a first evocation current level;
continuing to cause, by the stimulation system, stimulation of the tissue with a second evocation pulse from the sequence of pulses to evoke a second muscular response, the causing comprising:
decreasing the frequency of the delivery of each pulse in the sequence of pulses; and
increasing the current level of each pulse in the sequence of pulses from the immediately preceding pulse by a second current increment;
determining, by the stimulation system, that the second evocation pulse from the sequence of pulses evokes the second muscular response;
wherein the second evocation pulse has a second evocation current level that is greater than the first evocation current level; and
storing, by the stimulation system, based at least in part on the determination that the first evocation pulse evokes the first muscular response and the determination that the second evocation pulse evokes the second muscular response, the first evocation current level as the stimulation threshold current level.
The difference between the rejected claims of the instant application and patented claims of the patent lies in the fact that the patented claims are more specific. Thus, the invention of patented claims is in effect a “species” of the “generic” invention of rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since rejected claims are anticipated by patented claims, it is not patentably distinct from patented claims.
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791