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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/14/2025 has been entered.
Claims 8, 10-13, 26-27, 29, and 31-34 remain pending and under prosecution.
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), and Gerber et al (US Pub No. 2011/0040546).
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 signal, best seen in Figure 2 (0074);
at least one sensor 212 configured to sense, via an evoked response device with one or more evoked response device processors 215, 265, 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. It is noted that Osorio (‘711) 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.
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 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 a concrete efficacy indicator.
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), and Gerber et al (US 2011/0040546), 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) and Gerber et al 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) and Gerber et al 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, the number and polarity of minima, and the number and polarity of maxima are the same (paragraph 0042).
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) and Gerber to further incorporate the shape similarity analysis taught by Osorio because the comparison of the shapes of two signals, including number of phases, maxima, and minima, is known in the art to be an effective method of determining signal similarity, as demonstrated by Osorio (‘2012).
Regarding claims 11, 12, and 32-33, Osorio (‘711) in view of Gielen et al and Harris et al or Osorio (‘795) and Gerber et al 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) and Gerber et al 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 filed have been fully considered but they are not persuasive. However, applicant merely contends that “the claims require initiat[ing] a real time comparison of amplitude data and a test brain evoked response which is not disclosed, taught, or suggested by the references” (Remarks pg. 14).
Gerber et al, which was previously used to reject dependent claims above and not addressed, was previously set forth to teach the real time comparison (as taught in the manner above) further includes comparing amplitude data.
Applicant has not addressed why the teachings of Gerber et al combined with the combination of references above would not result in the real time comparison of amplitude data and a test brain evoked response as claimed. It is submitted that the invention as claimed implies real time for the various steps, and thus a real time comparison of amplitude data (among other criteria such as that listed in Claim 10) with a test brain evoked response is made obvious from Osorio (‘711) in view of Harris et al or Osorio (‘795), as previously presented.
It is also unclear what difference if any exists between the amendment to the claimed dated 9/5/2025 and the limitation presented on 6/9/2025, which merely moves the real time comparison includes comparing amplitude data limitation earlier in the claim. No difference is interpreted from said amendment and therefore, the rejection is maintained.
It is noted that applicant’s specification and original claims never explicitly state “real time comparison.” The use of “real time” language was suggested by the office and agreed upon as generally encompassed by the disclosure in the Nonfinal dated 3/9/2022, and then amended into the claims filed 6/27/2022 by applicant. Thus, it is noted that the use of “real time comparison” does not distinguish from the art as made obvious in the manner above.
The previous 112 rejection is withdrawn in light of applicant’s amendment.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791