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 .
This is a continuation of applicant's earlier Application No. 17/241523. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 16/804878 and 17/241523, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The prior applications do not provide adequate support or enablement for delivering reversible electroporation “having a frequency of 5 to 15 hertz”, in combination with the other steps or elements in the claim(s). The original disclosure and prior application discussed using a different range of “about” 5-15 Hz (e.g. page 8, lines 9-13, para. 30 in publication, etc.) and it being used to increase the blood pressure.
In addition, the prior application discussed delivering “stimulation” of about 5-15 Hz, but did not discuss a particular frequency being used for electroporation and its inhibitory pulses. The disclosure specifically noted the difference of the inhibitory pulses of electroporation versus the stimulation pulses (e.g. page 13, lines 7-12; para. 50, etc.).
Similarly, a pulse width of 1-3 milliseconds was not described as being used with reversible electroporation.
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application:
The prior applications did not provide adequate support for delivering reversible electroporation “having a frequency of 5 to 15 hertz”, in combination with the other steps or elements in the claim(s). The original disclosure and prior application discussed using a different range of “about” 5-15 Hz (e.g. page 8, lines 9-13, para. 30 in publication, etc.) and it being used to increase the blood pressure.
In addition, the prior application discussed delivering “stimulation” of about 5-15 Hz, but did not discuss a particular frequency being used for electroporation and its inhibitory pulses. The disclosure specifically noted the difference of using the inhibitory pulses of electroporation versus the stimulation pulses (e.g. page 13, lines 7-12; para. 50, etc.).
Similarly, a pulse width of 1-3 milliseconds was not described as being used with reversible electroporation.
This application repeats a substantial portion of prior Application Nos. 16/804878 and 17/241523, and adds disclosure not presented in the prior applications. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The subject matter which was not described in the specification is delivering reversible electroporation “having a frequency of 5 to 15 hertz”, in combination with the other steps or elements in the claim(s). The disclosure discussed using a different range of “about” 5-15 Hz (e.g. page 8, lines 9-13, para. 30 in publication, etc.) and the stimulation being used to increase the blood pressure. In addition, the disclosure discusses delivering “stimulation” of about 5-15 Hz, but does not discuss a particular frequency being used for electroporation/inhibitory pulses. The disclosure specifically noted the difference of the inhibitory pulses of electroporation versus the stimulation pulses (e.g. page 13, lines 7-12; para. 50, etc.). The limitations of claim 4 depended on claim 2, where claim 2 discussed the use of decreasing a blood pressure of the patient with stimulation of 5-15 Hz. This specifically goes against the current disclosure of delivering stimulation to “increase” the blood pressure with a frequency of 5-15 Hz (e.g. pages 8-9; paras. 30, 34, etc.). Similarly, a pulse width of 1-3 milliseconds was not described as being used with reversible electroporation.
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 1-5 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Vase et al (2014/0067003) in view of Deem et al (2007/0021803).
Vase discloses the claimed system and method as follows:
--using an implanted lead with multiple electrodes (e.g. element 10, etc.) for modulation of the stellate ganglion (e.g. para. 87, claims 2 and 10, etc.; therefore proximal the heart; to inhibit/block the neural activity, paras. 11, 35, 103, etc.) to control hypertension/blood pressure while sensing the blood pressure in a closed loop fashion to continually control the stimulation (e.g. abstract, paras. 32, 70, 91, 155, 156, etc.; co-located with the electrode device; to lower blood pressure in paras. 142, 155, etc.).
--Vase also discloses that the stimulation is initially tested and the blood pressure is sensed to determine if the device is in the correct position, and if not in the correct position, the lead/electrodes are moved to have an electrode properly placed near the target tissue (e.g. paras. 31-32, 94-99, 159, etc.). Vase also discloses that the system uses multiple different types of therapies to lower the blood pressure and that the stimulation is reversible, so as to not ablate/damage the target area (e.g. paras. 23, 24, 26, etc.), but does specifically state that the electrical stimulation is reversible electroporation and uses a frequency of 5-15 Hz.
Vase does specifically note that the frequency of the stimulation is to be changed, such as ramping it up while monitoring blood pressure and heart rate, until the proper frequency is found as different patients and physiological structures require different stimulation frequencies (e.g. paras. 32, 98, 110-111, etc.). Deem teaches that it is known to use reversible electroporation for modulation of the neural structures of the body, such as the stellate ganglion, in order to provide a reversible electrical therapy that is easy to use for selective disruption/modulation of conduction pathways in the body. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Vase, with reversible electroporation for modulation of the neural structures of the body, such as the stellate ganglion, as taught by Deem, and with a frequency such as 5-15 Hz, since it would provide the predictable results of a reversible electrical therapy that is easy to use for selective disruption/modulation of conduction pathways in the body, without destroying/damaging the neural tissue. And in regards to the 5-15 Hz frequency, Vase provides a clear suggestion that the frequency can be modified to determine the best frequency, such as 5-15 Hz, so as to provide proper therapy without hurting the patient. The determination of the most appropriate frequency, such as 5-15 Hz by routine experimentation would, therefore, be prima facie obvious to one having ordinary skill in the medical art.
In addition or in the alternative, for the 5-15 Hz, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the frequency to be 5-15 Hz, because Applicant has not disclosed that the specific frequency of 5-15 Hz provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the determination of the proper frequency through testing as taught by Vase, because it allows the specific frequency for the particular patient to be determined, since different patients have different physiology. Therefore, it would have been an obvious matter of design choice to modify Vase to obtain the invention as specified in the claim(s).
In regards to claim 3, note that claim 2 uses “or” and that claim 3 does not specifically state that the pulse width is being chosen from claim 2. For claim 2, the examiner is using the output voltage or frequency of Vase, or Vase in view of Deem, as meeting the claimed limitations and therefore the pulse width of claim 3 does not need to be found.
Claims 1-5 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Vase et al (2014/0067003) in view of Deem et al (2007/0021803) and Darvish et al (7171263). Vase discloses the claimed system and method as follows:
--using an implanted lead with multiple electrodes (e.g. element 10, etc.) for modulation of the stellate ganglion (e.g. para. 87, claims 2 and 10, etc.; therefore proximal the heart; to inhibit/block the neural activity, paras. 11, 35, 103, etc.) to control hypertension/blood pressure while sensing the blood pressure in a closed loop fashion to continually control the stimulation (e.g. abstract, paras. 32, 70, 91, 155, 156, etc.; co-located with the electrode device; to lower blood pressure in paras. 142, 155, etc.).
--Vase also discloses that the stimulation is initially tested and the blood pressure is sensed to determine if the device is in the correct position, and if not in the correct position, the lead/electrodes are moved to have an electrode properly placed near the target tissue (e.g. paras. 31-32, 94-99, 159, etc.). Vase also discloses that the system uses multiple different types of therapies to lower the blood pressure and that the stimulation is reversible, so as to not ablate/damage the target area (e.g. paras. 23, 24, 26, etc.), but does specifically state that the electrical stimulation is reversible electroporation and that the frequency to use is 5-15 Hz. Vase does specifically note that the frequency of the stimulation is to be changed, such as ramping it up while monitoring blood pressure and heart rate, until the proper frequency is found as different patients and physiological structures require different stimulation frequencies (e.g. paras. 32, 98, 110-111, etc.).
Deem teaches that it is known to use reversible electroporation for modulation of the neural structures of the body, such as the stellate ganglion, in order to provide a reversible electrical therapy that is easy to use for selective disruption/modulation of conduction pathways in the body. Darvish teaches with sufficient specificity a frequency of 10 Hz to use for reversible electroporation (e.g. col. 1, lines 20-27, col. 9, lines 50-51, etc.). It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Vase, with reversible electroporation for modulation of the neural structures of the body, such as the stellate ganglion, as taught by Deem, and the use of a frequency of 10 Hz as taught by Darvish, since it would provide the predictable results of a reversible electrical therapy that is easy to use for selective disruption/modulation of conduction pathways in the body, without destroying/damaging the neural tissue, and applying the therapy at a proper frequency to provide effective electroporation.
In regards to claim 3, note that claim 2 uses “or” and that claim 3 does not specifically state that the pulse width is being chosen from claim 2. For claim 2, the examiner is using the output voltage or frequency of Vase, or Vase in view of Deem and Darvish, as meeting the claimed limitations and therefore the pulse width of claim 3 does not need to be found.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Vase in view of Deem, or Vase in view of Deem and Darvish. Vase discloses that the device can be anchored proximal the target area (e.g. para. 160, etc.) but Vase in view of Deem, or Vase in view of Deem and Darvish, do not disclose screwing or clamping the device or using a barb or hook to secure the device. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified they system and method as taught by Vase in view of Deem, or Vase in view of Deem and Darvish, with screwing or clamping the device or using a barb or hook to secure the device, as is well known and common knowledge in the art (mpep 2144), since it would provide the predictable results of firmly holding the device at the target location so the device does not become dislodged during movement/physical activity of the patient.
Conclusion
This is a continuation of applicant's earlier Application No. 17/241523. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 2/16/26