DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/10/2026 has been entered.
Claims 8, 10-13, 26-27, 29, and 31-34 remain pending and under prosecution.
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 8, 10-13, 26-27, 29, and 31-34 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 regard to Claim 8, the recitation of “location…of maxima” in the real time comparison step is indefinite because it is unclear exactly what is meant by location. The identification of a maxima in a waveform may constitute “a location” however it is unclear if this is what is intended in the interpretation of the claim. Additionally, the specification provides no mention of the term “location of maxima” so no details can be found in the disclosure.
In regard to Claim 8, the recitation of “one or more processors configured to initiate a real time comparison of amplitude data, polarity, location and number of maxima of the evoked response” and “wherein the test evoked response is similar to the therapeutic response based on a number and a polarity of maxima being similar or identical” seem to contradict each other because both are referring to the comparison step of the evoked response to the prior evoked response elicited by a therapeutically efficacious electrical signal. The first limitation states the comparison includes “amplitude data, polarity, location and number of maxima of the evoked response” but the latter limitation states the comparison is based on “number and a polarity of maxima being similar or identical.” This contradiction renders the claim indefinite because it is unclear if the comparison and thus identification of similar or identical is based on “amplitude data, polarity, location and number of maxima” or only “number and a polarity of maxima” or some other combination. Clarification is requested. In the rejection below, for Claim 8, the claim is interpreted as using number and a polarity of maxima along with amplitude for the comparison.
In regard to Claim 10, the recitation of “the number and the polarity of minima” appears to lack proper antecedent basis. Clarification is requested.
In regard to Claim 29, a similar contradiction exists as explained above for claim 8 except the limitation is “one or more processors configured to initiate a real time comparison of amplitude data” and “wherein the test evoked response is similar to the therapeutic response based on a number and a polarity of maxima being similar.” As explained above, the contradiction makes it unclear if the comparison should be on amplitude or a number and a polarity of maxima, or all three. In the rejection below, for Claim 29, the claim is interpreted as using number and a polarity of maxima along with amplitude for the comparison. Clarification is requested.
Claims 11-13, 26-27, and 31-34 are rejected by virtue of dependence on Claims 8 and 29, respectively.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 8, 13, 26-27, 29, and 34 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Osorio (US Pub No. 20120046711) in view of Gielen et al (US Pub No. 20020188330), and Harris et al (US Pub No. 20080021341) or Osorio (US Pub No. 20110160795), Gerber et al (US Pub No. 2011/0040546), and Osorio (US 20070244407).
Regarding Claims 8 and 29, Osorio (‘711) discloses at least one electrical pulse generator 275, best seen in Figure 2 (0074);
at least one electrode 282 configured to deliver a first electrical pulse and elicit an evoked response from a neural structure such as a brain, best seen in Figure 2 (0074);
at least one sensor/evoked response device 212 configured to sense form the neural structure, a brain evoked response elicited by a delivery of the first electrical signal to a neural structure, best seen in Figure 2 (0055, 0067-0068) – it is noted the sensor is configured to sense from the brain in real time with delivery of the first electrical signal; and
a medical device, comprising:
one or more processors 215, 276, 285 configured to automatically adjust (Figure 11-2, steps 1150 and 1357) at least one parameter such as selected from an inter-pulse interval, a current magnitude, a pulse width, a pulse shape, and a pulse polarity (0075) when the brain evoked response is not considered a therapeutically efficacious brain evoked response (0096, 0098, 0116-0117, 0145-0146);
the one or more processors 266 configured to determine an efficacy index of the evoked response, wherein the efficacy index provides a normalized indication of a reduction of a seizure intensity, a seizure duration, and a seizure spread resulting from the test evoked response (0081-0082, 0084 – normalized, 0085, 0087, 0091 – duration, spread, 0094 – intensity, 0095, 017, 0138-0146); and
a memory configured to store at least one of the parameter of an adjusted first electrical signal, best seen in Figure 2 (0063, 0107-0108, 0114).
However, Osorio (‘711) does not expressly disclose automatically adjusting a pulse charge balancing of the first delivered electrical signal when the brain evoked response is not considered a therapeutically efficacious brain evoked response.
It is noted that Osorio (‘711) explicitly disclose the therapy signal, which corresponds to the first delivered electrical signal, may be modified to take into account charge balance considerations (0037, 0119, 0123, 0125). Osorio (‘711) also explicitly states “based upon the efficacy indication(s), the therapy may be terminated, modified or continued” (0037). It is also noted that applicant has not expressed any importance toward the use of automatically adjusting a pulse charge balancing of the first delivered electrical signal when the brain evoked response is not considered a therapeutically efficacious brain evoked response as solving a particular problem, conferring a specific advantage, or providing a desired result other than being one of many characteristics of the first electrical signal that may be modified during the process, since Osorio (‘711) already discloses modifying various pulse parameters of the first delivered electrical signal when the brain evoked response is not considered a therapeutically efficacious brain evoked response such as an inter-pulse interval, a current magnitude, a pulse width, a pulse shape, and a pulse polarity (0075, 0126, 0145).
Gielen et al teach that it is well-known in the art to automatically adjust a pulse charge balancing of a delivered electrical signal during therapy over each waveform cycle or period, especially chronic therapy, to prevent tissue damage to the patient as a result of charge imbalances (0044). Gielen et al also disclose automatic adjustment of other parameters such as amplitude, current magnitude, inter-pulse interval, and pulse shape (0042-0044).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Osorio (‘711) such that there is automatically adjusting of a pulse charge balancing of the first delivered electrical signal when the brain evoked response is not considered a therapeutically efficacious brain evoked response as already suggested by Osorio (‘711) to effectively configure the next, second electrical signal to provide optimal therapy to the patient by modifying a known and disclosed characteristic of the electrical signal as already disclosed by Osorio (‘711) that also avoids tissue damage, as taught by Gielen et al.
However, Osorio (‘711) does not expressly disclose the one or more processors configured to compare the brain evoked response elicited by the first delivered electrical signal to a brain evoked response elicited by a prior delivered electrical signal known to be therapeutically efficacious; the one or more processors configured to determine whether the brain evoked response elicited by the first electrical signal is sufficiently similar to the therapeutically efficacious brain evoked response, where sufficiently similar is achieved by reaching a threshold value; in response to the brain evoked response being insufficiently similar to the therapeutically efficacious brain evoked response, adjusting at least one parameter of the electrical signal.
It is noted that Osorio (‘711) disclose that therapeutically efficacious is determined by reaching/matching a threshold value of efficacy threshold and not therapeutically efficacious is determined by not reaching/not matching said threshold value (0141).
Harris et al teach that it is well-known in the art to provide an analogous device comprising comparing (last step of Figure 13) brain response signals, i.e. EEG, for a seizure therapy to brain response signals (EGG) from a prior delivered therapy known to be therapeutically efficacious, i.e. comparing second follow up data to other follow up data determined to be therapeutically efficacious, as an objective manner of comparing the efficaciousness of the therapy (0171). The comparison thus allows the standard of therapeutically efficacious to be defined by the therapy itself versus being defined only by the desired outcome.
Osorio (‘795) teach that it is well-known in the art to provide an analogous device comprising comparing (0053, 0148-0149) the brain evoked response elicited by the first delivered electrical signal (abst) to a brain evoked response elicited by a prior delivered electrical signal known to be therapeutically efficacious (defined in the therapy response map 0053, 0148-0149), steps 235-240 in Figure 39 (0186, 0190); in response to the brain evoked response being insufficiently similar to the therapeutically efficacious brain evoked response, the therapy is determined to be not efficacious and may be adjusted (abst, 0047, 0187). Thus, Osorio (‘795) teach the advantage of comparing the brain evoked response signal from one therapy to another enables another objective manner of tracking the efficaciousness of the therapy by comparing the instant therapy to another therapy already defined as therapeutically efficacious in a library, instead of just being compared to the desired symptom outcome for the patient. This also enables various efficacious therapies to be selected and saved for future use.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the invention of Osorio (‘711) such that the one or more processors configured to compare the brain evoked response elicited by the first delivered electrical signal to a brain evoked response elicited by a prior delivered electrical signal known to be therapeutically efficacious, as taught by Harris et al or Osorio (‘795), to provide an equally as effectively manner to track the efficaciousness of the therapy by the first electrical signal by comparing the therapy to a known efficacious therapy, such that when combined with Osorio (‘711), the one or more processors are configured to determine whether the brain evoked response elicited by the first electrical signal is sufficiently similar to the therapeutically efficacious brain evoked response, where sufficiently similar is achieved by reaching a threshold value, as already taught by Osorio (‘711); in response to the brain evoked response being insufficiently similar to the therapeutically efficacious brain evoked response, by not reaching/matching the threshold value as taught by (‘711), adjusting at least one parameter of the electrical signal, also already taught by (‘711), wherein the result of being able to define the instant therapy as efficacious when compared to a prior defined efficacious therapy enables the instant therapy to be saved and designated as therapeutic for future use.
In terms of the timing, it is noted that the combination of Osorio (‘711) with Harris et al or Osorio (‘795) make obvious to one of ordinary skill in the art to perform the comparison in “real time” for benefits such as faster treatment of the patient because once the efficacy of the first delivered electrical signal is determined by the comparison in real time, it would enable the electrical signal to be adjusted to properly provide therapy to the patient during a time of need, i.e. during a seizure.
Osorio (‘711) already disclose that the method can be performed in “real time” or “offline” as would be advantageous (0041, 0045). Harris et al is also concerned with sampling and analysis of the patient’s EEG signals in response to the analogous implanted device in real time (0082-0084, 0120, 0132 – real time analysis). Osorio (‘795) also discloses the consideration of “real time” or “offline” as desired (0003, 0042, 0048, 0095, 0138).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention was made to have the comparison of Harris et al or Osorio (‘795) performed in real time (and not just offline) with the invention of Osorio (‘711) to effectively provide benefits such as faster treatment of the patient because once the efficacy of the first delivered electrical signal is determined by the comparison in real time, it would enable the electrical signal to be adjusted as quickly to properly provide therapy to the patient during a time of need, i.e. during a seizure.
However, Osorio (‘711) does not expressly disclose the real time comparison (as taught in the manner above) further includes comparing amplitude data and a number and a polarity of maxima.
As previously noted, Osorio (‘711) already discloses modifying various pulse parameters of the first delivered electrical signal when the brain evoked response is not considered a therapeutically efficacious brain evoked response such as an inter-pulse interval, a current magnitude, a pulse width, a pulse shape, and a pulse polarity (0075, 0126, 0145).
Osorio (‘711) also states that “an efficacious effect may be determined from a change in at least one of an amplitude variance” (0086).
Gerber et al teach that comparing amplitude data enables determination of efficacy of a therapy relative to a known efficacious therapy – “a change in a therapy field may adversely affect the efficacy of therapy delivered to the patient. For example, if at least one field characteristic of a present therapy field differs from a respective field characteristic of a therapy field known to result in efficacious therapy to the patient (e.g., a "baseline" therapy field), the present therapy field may provide less than a desirable level of therapeutic efficacy. The field characteristic may include… an amplitude of the voltage or current at a certain spatial point within stimulation volume, a charge density, or the like” (0006). It is clear that “a change” can only be determined through the act of comparison.
Osorio (‘407) teach that it is well-known in the art that an analogous evoked response elicited by an electrical pulse is assessed by polarity and number of maxima – “number of peaks, polarity” (claim 5).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Osorio (‘711), which already discloses the use of “real time” (0041, 0045) and as modified in the manner above to include real time comparison includes comparing amplitude data as taught by Gerber et al, and also to use a number and a polarity of maxima, as suggested by Osorio (‘407) to effectively determine the efficacy of the first electrical signal by comparison of its brain evoked response to the therapeutically efficacious brain evoked response, in the manner made obvious above, by using the metric of amplitude as well as a number and a polarity of maxima as a concrete efficacy indicator. It is noted that for Claim 8, the teaching of a maxima is considered to be a location on a waveform, as broadly as has been claimed. Also see 112 rejections above.
Regarding Claim 13 and 34, Osorio (‘711) further teaches the neural structure is a vagus nerve (0060), a trigeminal nerve, a hypoglossal nerve, a glossopharyngeal nerve, or a brain structure.
Claim 26: Osorio (‘711) discloses the efficacy index comprises assessment of adverse effects of the test evoked response (0092, 0094, 0100, 0101, 0105, 0144).
Claim 27: Osorio (‘711) discloses the adjustment device is configured to adjust at least one parameter selected from the inter-pulse interval, the current magnitude, the pulse width, the pulse shape, the pulse polarity, and the pulse charge balancing of the delivered electrical signal, in response to the test evoked response causing an adverse effect (0092, 0094, 0096, 0098, 0100, 0101, 0105, 0116-0117, 0145-0146).
Claims 10-12, 31-32, and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Osorio (‘711) in view of Gielen et al and Harris et al or Osorio (‘795), Gerber et al (US 2011/0040546), and Osorio (‘407), further in view of Osorio (US 2012/0071774).
In regard to Claims 10 and 31, Osorio (‘711) in view of Gielen et al and Harris et al or Osorio (‘795), Gerber et al, and Osorio (‘407) teaches all of the elements of the current invention as stated above for claim 8 except specific criteria for the test evoked response being similar to the therapeutic response.
Gerber teaches that a test evoked response is similar to a therapeutic response if one or more of their latency, amplitude (paragraph 0006) or duration do not differ by more than 10% (paragraph 0096).
It would have been obvious at the time of the invention to one of ordinary skill in the art to modify the invention of Osorio (‘711) in view of Gielen et al and Harris et al or Osorio (‘795), Gerber et al, and Osorio (‘407) to incorporate the 10% amplitude similarity threshold taught by Gerber because such a comparison between evoked signal amplitudes is an effective means for quantifying how similar two evoked potential signals are and for determining if stimulation parameters should be modified, as demonstrated by Gerber.
Osorio (‘2012) teaches that a test evoked response is similar to a therapeutic response if the number and polarity of phases and the number and polarity of minima are the same (paragraph 0042). It is noted that Osorio (‘711) also teach modifying the therapy to be efficacious includes number and polarity of phases – “number of phases in a pulse, number of phases in a pulse burst, polarity of pulse phase” (0075, 0145).
It would have been obvious at the time of the invention to one of ordinary skill in the art to modify the invention of Osorio (‘711) in view of Gielen et al and Harris et al or Osorio (‘795), Gerber, and Osorio (‘407) to further incorporate the shape similarity analysis taught by Osorio (‘2012) because the comparison of the shapes of two signals, including number of phases, and minima, is known in the art to be an effective method of determining signal similarity, as demonstrated by Osorio (‘2012) as well as Osorio (‘711).
Regarding claims 11, 12, and 32-33, Osorio (‘711) in view of Gielen et al and Harris et al or Osorio (‘795), Gerber et al, and Osorio (‘407) teaches all of the elements of the current invention as stated above for claim 8 except an autocorrelation function.
Regarding claim 11 and 32, Osorio ('2012) teaches one or more processors that implements an autocorrelation function between a test evoked response and a therapeutic evoked response (paragraph 0084).
Regarding claim 12 and 33, Osorio ('2012) further teaches the test evoked response and the therapeutic evoked response are similar if the value of said autocorrelation function is at least 0.9 (paragraph 0084).
It would have been obvious at the time of the invention to one of ordinary skill in the art to modify the invention of Osorio (‘711) in view of Gielen et al and Harris et al or Osorio (‘795), Gerber et al, and Osorio (‘407) to incorporate the autocorrelation function taught by Osorio ('2012) because such a function is an effective means for measuring the similarity between two evoked potential signal shapes, thus providing a useful quantification of signal similarity.
Response to Arguments
Applicant’s arguments with respect to claim(s) above 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.
Applicant contends that Gerber et al do not teach comparison of amplitude data and a test brain evoked response and wherein the test evoked response is similar to the therapeutic response based on a number and polarity of maxima being similar/identical (Remarks pg. 14). It is noted that Osorio (‘407) is set forth to teach the number and polarity of maxima as obvious features of the evoked response, and the combination above would thus teach the comparison of amplitude data and number and polarity of maxima with a test brain evoked response to be similar/identical to assess the efficacy of the test brain evoked response, when Osorio (‘711) is combined with Harris et al or Osorio (‘795) in the manner above as previously set forth. Also see the new 112 rejections above.
Conclusion
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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