DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The claims are objected for having incorrect numbering. Namely, the claim et jumps from Clam 28 to Claim 30. There is not a claim 29. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the two sets of signals supplied at two separate periods of time wherein the second set of signals have one or more frequencies, pulse widths and amplitudes less that corresponding features of the first set of signals at the first predetermined period of time and the ramping down of one or both sets of signals according to the claim language must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Fig.9 is currently believed to be the closets figure to the claimed invention but only shows one signal.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-36 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.
Regarding Claim 1, Applicant claims “generating first electrical stimulation signals” and “generating second electrical stimulation signals”. Applicant then claims “as one or more of the frequencies, pulse widths, and amplitudes of the electrical stimulation signals provided to the patient…”. It is unclear if “the stimulation signals” are referring to the first stimulation signals, the second stimulation signals or both the first and second stimulation signals.
Additionally, Claim 1 includes the step of “continue to be successively reduced”. However, there is not a previous mention of successively reducing any stimulation signal so it is unclear what this step is a continuation of. It is further unclear what signal (the first, second or both) is being reduced and when the initial reduction is supposed to take place so that the step of continuing to reduce the signal can occur as claimed. For the purposes of examination, the Claims will be interpreted as a set of stimulation signals that can start at a high value and be ramped down over time (see Fig. 9 for an example of a single signal that can be successively reduced). Appropriate clarification and/or correction is respectfully requested.
Regarding Claim 5, Applicant provides 4 mutually exclusive options that cannot all be true at the same time and links them with the term “and” and not “:or”. It is unclear if Applicant is intending one signal to have one set of value and the other to have another set of values; if only one set of values has to apply to only one signal; or if Applicant is attempting to claim four signals having four distinct sets of values.
Claim 6 recites the limitation "the chronic electrical stimulation signals" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 does not include any positively recited method steps. Instead, the claim simply, states the patient can use an app not that the patient actually sues an app. If Applicant intends to require the usage of an app, the Examiner suggests amending the claim to recite “inputting one or more feelings of satiety, fullness, vomiting and nausea through an app” or some variant thereof. As currently recited, the Examiner notes any human is certainly capable of putting information into an app. The metes and bounds of the claim are currently unclear.
Claim 30 recites the limitation "the tunnel, the first space, the second space or the submucosal layer". There is insufficient antecedent basis for these terms in the claim. Claim 30 also uses the term “the stimulator” which lacks antecedent support in the claims.
Claim 35 sets forth “the method further comprises one or ore GPOEM steps, techniques or methods.” Applicant has not firs set forth the full name of the acronym GPOEM. It is also unclear what steps this would include and how said steps would integrate with the already claimed method. The metes and bounds are unclear. Applicant is essentially setting forth the use of a process “without any active, positive steps delimiting how this use is actually practiced” (see MPEP §2173.05(q)).
Claims 2-5, 7-18, 20-29 and 31-36 are rejected due to their dependence on indefinite Claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 9, 10 and 19-28 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (2019/0099601).
Regarding Claims 1, 10, 20 and 25, Torgerson discloses treating gastrointestinal disorders such as obesity, pelvic/ abdominal pain, etc. (par. [0002, 0029]) by implanting an IPG 102 in a patient and delivering electrical stimulation through at least one lead 16A, B having one or more electrodes 116, 118 (Fig. 1, 2), wherein the stimulation has frequencies upwards of 1 Hz, such as 50-500 Hz (par. [0067]); pulse widths that can range from 60 microseconds to upwards of 2000 microseconds (par. [0079, 0080]); amplitudes that can includes 5 mA; 10 mA (par. [0043]; 2 mA (par. [0091]), etc.. Torgerson further discloses that an initial set of parameters can be applied (Applicant’s first electrical stimulation signals) and then discloses the amplitude can be gradually decreased, see Fig. 3C (any of the subsequent stimuli delivered corresponding to the adjusted parameters can be Applicant’s second electrical stimulation signals). Torgerson does not disclose the exact parameters ranges of frequencies between 2-120 Hz; pulse widths of 100 microseconds to 10 milliseconds; or amplitudes between 0.1mA and 20 mA. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed inventio to use values in these ranges, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
In regard to Claim 2, Torgerson discloses making multiple adjustments of amplitude over time. The first adjustment would result in a second signal at a second time; the third adjustment would be a third signal at a third time, etc. (see Fig. 3C; par. [0095])).
Regarding Claim 3, Torgerson discloses the stimulation has frequencies upwards of 1 Hz, such as 50-500 Hz (par. [0067]) and pulse widths that can range from 60 microseconds to upwards of 2000 microseconds (par. [0079, 0080]). Torgerson does not disclose the exact parameters ranges of frequencies between 10-11Hz and pulse widths of 200 microseconds to 500 microseconds. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed inventio to use values in these ranges, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
In regard to Claim 9, Torgerson discloses incorporating an accelerometer or patient posture sensor in the device (par. [0046]).
Regarding Claim 19, Torgerson discloses an external device 104 that a patient can interact with (Fig. 1; par. [0034]).
With regard to Claims 21, 23 and 24, Torgerson discloses electrical stimulation electronics 202 and a power source 220 within a housing 102 (Fig. 1, 2).
In regard to Claim 22, Torgerson discloses telemetry circuit 208 that allows communication with programmer 104 (Fig. 1, 2).
Regarding Claims 26-28, Torgerson discloses multiple electrodes that can have adjustable polarities thus allowing for unipolar, bipolar and multipolar configurations (par. [0026, 0028]).
Claims 1-5, 11 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dobak (US Patent 7,937,145).
Regarding Claims 1 and 11, Dobak discloses treating gastrointestinal disorders such as those causing pain such as ulcers, esophageal reflux, gastroparesis, irritable bowel, etc. (col. 16, lines 29-49) by implanting a pulse generator that can deliver electrical stimuli having a frequency of 0.5 Hz to 300 Hz; pulse widths from 10 microseconds to 1000 microseconds; and current amplitudes of 0.1mA to 20 mA (col. 40, lines 38-55). Dobak further discloses employing a dynamic ramping technique in which a current intensity starts at a high value and then is gradually reduced down to a lower value (Fig. 18). The first time period for first stimulation could be day 1, 2 or 3 from Fig. 18. The second time period for second stimulation could be any day after the initial day in which stimulation intensity is decreased. Dobak does not disclose the exact parameters ranges of frequencies between 2-120 Hz; pulse widths of 100 microseconds to 10 milliseconds; or amplitudes between 0.1mA and 20 mA. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed inventio to use values in these ranges, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
In regard to Claim 2, Dobak discloses making multiple adjustments of amplitude over time. The first adjustment would result in a second signal at a second time; the third adjustment would be a third signal at a third time, etc. (see Fig. 18).
Regarding Claim 3, Dobak discloses a pulse generator that can deliver electrical stimuli having a frequency of 0.5 Hz to 300 Hz; pulse widths from 10 microseconds to 1000 microseconds; and current amplitudes of 0.1mA to 20 mA (col. 40, lines 38-55). Dobak does not disclose the exact parameters ranges of frequencies between 10-11Hz and pulse widths of 200 microseconds to 500 microseconds. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use values in these ranges, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
With regard to Claims 4 and 5, Dobak discloses varying the duty cycle from 1% to 100% (col. 36, lines 45-46) and notes values for on and off times can range from 15 seconds in some examples to upwards of a minute (these are just exemplary and cover only a small range of the percentages disclosed (col. 36, lines 54-62).) Dobak does not disclose the exact ranges of 0.1 seconds to 10 seconds on and 1 second to 20 seconds off. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use values of 0.1 seconds to 10 seconds on and 1 second to 20 seconds off, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding Claim 13, the Examiner notes the language “configured to mimic” does not set forth any particular stimulation parameters and instead appears to claim a result of the stimulation parameters of Claim 1. The Examiner contends the parameters as disclosed in Claim 1 (and disclosed by modified Dobak) provide this result. If this is not the case, the Examiner suggests amending the claim to include parameters or features of stimulation that provide this capability.
This also applies to claims 14 and 15 and therefore claims 14 and 15 are likewise rejected with respect to modified Dobak.
In regard to Claim 16, Dobak discloses the stimulation can be applied at meal times (col. 20, lines 50-51).
Regarding Claim 17, Dobak discloses stimulation can occur at meal times ((col. 20, lines 50-51)) and that each day the amplitude can be adjusted down (Fig. 18); therefore the adjustment would also occur at a meal time.
In regard to Claim 18, Dobak discloses programming the IPG with a programmer and that the stimulation occurs based on its programming (i.e. timers within the device). The programming can also be considered a form of physician control since they prescribe the therapy. Additionally, Dobak discloses it can be patient controlled (col. 48, line 65- col. 49, line 12).
Claims 1, 6-8, 11, 12, 20 and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Starkebaum et al. (2011/0071589).
Regarding Claims 1 and 20, Starkebaum discloses implanting a gastrointestinal stimulator to treat obesity by creating feelings of satiety (Abstract; par. [0006]). Starkebaum discloses an IPG 12 with leads 18, 20 and electrodes 24, 26 (Fig. 1) that applies signals having frequencies ranging from 0.5 Hz to 40 Hz (par. [0011, 0124]); pulse widths ranging from 0.5 milliseconds to 20 milliseconds; and amplitudes from 1 to 25 milliamps (par. [0124]). Starkebaum further discloses applying multiple signals, wherein a first signal in a first time has a greater amplitude than a second signal in a second time (see PW7, PW8 in Fig. 6B). Starkebaum does not disclose the exact parameters ranges of frequencies between 2-120 Hz; pulse widths of 100 microseconds to 10 milliseconds; or amplitudes between 0.1mA and 20 mA. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed inventio to use values in these ranges, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
In regard to Claims 6-8, Starkebaum discloses not providing stimulation and therefore reducing amplitude, frequency, pulse width of a stimulation signal, during a sleeping state of a user (the daily off period was selected to coincide with sleep, see par. [0196]).
Regarding Claims 11 and 12, Starkebaum discloses treating delayed gastric emptying (par. [0048]).
regarding Claim 31, Starkebaum discloses a bipolar pair of electrodes which makes one electrode a return electrode (par. [0075]).
In regard to Claim 32, Starkebaum discloses implanting the stimulator endoscopically in a submucosal layer (par. [0075]).
regarding Claims 33 and 34, Starkebaum discloses anchoring the device with fixation members such as tines (barbs) helical structures, etc. (par. [0079]).
Claims 1, 20, 25, 30, 32, 33, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Bitton et al. (2008/0065168) in view of Starkebaum et al. (2011/0071589).
Regarding Claims 1, 20, 25, 30, 32, 33, 35 and 36, Bitton discloses an ingestible, temporary stimulator 30 that is configured to be set within an ingestible capsule 34 that can be guided with an endoscope and secured with a tine (hook) (Fig. 1A-C, 4A; par. [0179-0180, 0204]). The device is configured to treat obesity such as by increasing feelings of satiety (par. [0002, 0039]) by applying electrical signals to electrodes 38, the electrical signals having frequencies ranging from 40-120 Hz and amplitudes ranging from 1 to 20 mA (par. [0197]). Bitton discloses coupling elements (leads) 37, 40 are configured to dissolve after a time so that the stimulator can safely pass through the digestive tract after use (par. [0139, 0183]). Bitton is silent regarding pulse width ranges and is silent regarding the exact parameters ranges of frequencies between 2-120 Hz; pulse widths of 100 microseconds to 10 milliseconds; or amplitudes between 0.1mA and 20 mA. In the same field of endeavor of treating obesity by controlling feelings of satiety, Starkebaum discloses applying signals having frequencies ranging from 0.5 Hz to 40 Hz (par. [0011, 0124]); pulse widths ranging from 0.5 milliseconds to 20 milliseconds; and amplitudes from 1 to 25 milliamps (par. [0124]). Starkebaum further discloses applying multiple signals, wherein a first signal in a first time has a greater amplitude than a second signal in a second time (see PW7, PW8 in Fig. 6B). This provides the benefit of treating the disorder while also maintaining charge balance and thus avoiding corrosion of the electrodes due to electro chemical reactions on the surface of the electrodes (par. [0050]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Bitton reference to include a pulse width in the range of 0.5 msec to 20 msec and to reduce a pulse amplitude form one signal to the next, as taught and suggested by Starkebaum, for the purpose of treating the disorder while also maintaining charge balance and thus avoiding corrosion of the electrodes due to electro chemical reactions on the surface of the electrodes. Bitton and Starkebaum do not disclose the exact parameters ranges of frequencies between 2-120 Hz; pulse widths of 100 microseconds to 10 milliseconds; or amplitudes between 0.1mA and 20 mA. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed inventio to use values in these ranges, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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