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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 01/23/2026 has been entered.
Information Disclosure Statement
The IDS filed 01/23/2026 has been considered.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-9, 11-15, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shafer (US 2005/0075702).
Regarding claim 1, Shafer discloses a device or system comprising at least one electrode (Fig. 7E, lead 16 with electrodes 21-24), the at least one electrode configured to being placed on or around a pancreas-related sympathetic nerve of a subject located adjacent to a gastroduodenal artery or branch thereof, wherein the pancreas related sympathetic nerve supplies a lymphatic system of the pancreas (para. 56), and a signal generator for generating a signal to be applied to the pancreas-related sympathetic nerve via the at least one electrode (Fig. 6A, pulse generator 101; para. 67).
Shafer does not explicitly disclose that the signal reversibly modulates the neural activity of the pancreas-related sympathetic nerve to produce a change in a physiological parameter in the subject, wherein the change in the physiological parameter is at least two or more of the group consisting of: an increase in catecholamine levels in the pancreas, an increase in GABA levels in the pancreas, and an increase in the number of pancreatic beta cells in the pancreas.
Examiner submits that the above limitations amount to intended use of the claimed device because they are directed to effects of the claimed device structure. As such, the device requires the structure capable of delivering the stimulation in a manner as recited by the intended use. As shown above, Shafer discloses the required structure of a device comprising an electrode capable of being placed around sympathetic nerve as well as a signal generator. Furthermore, Applicant discloses that the generated signal requires a frequency of between 10-100Hz, a pulse width of 0.01 to 2 ms and an amplitude of .01 to 10mA (para. 88 of corresponding publication US 2023/0030204). Shafer para. 85 discloses a frequency about 1 Hz to about 120 Hz; the pulse width of 10 to 600 microseconds (0.01-0.6ms); and an amplitude of 1 to 20mA. In view of Shafer’s disclosure of equivalent device structure and stimulation parameters, Examiner submits that Shafer would be capable of delivering the stimulation in a manner that produces the claimed effects above (see also MPEP 2112.01(I)). Seeing also that Shafer is applied to the sympathetic nerve near the pancreas (e.g. para. 56) and applies the same stimulation signal, it would result in carrying out the same process as claimed resulting in the same effects (see also MPEP 2112.02).
Regarding claim 4, Shafer discloses the signal stimulates the neural activity of the pancreas-related sympathetic nerve (para. 56).
Regarding claim 5, Shafer discloses the signal generator is a voltage or current source configured to generate an electrical signal to be applied to the pancreas-related sympathetic nerve via the at least one electrode (para. 67; para. 85 discloses various voltage and current values which may be applied).
Regarding claim 6, Shafer discloses the at least one electrode is in the form of an electrode array (Fig. 7E, electrodes 21-24 form an array; see also Fig. 7B, electrodes 21-24).
Regarding claim 7, Shafer does not explicitly disclose the signal selectively stimulates the neural activity of nerve fibers supplying the lymphatic system of the pancreas. Examiner submits that the above limitations amount to intended use of the claimed device because they are directed to effects of the claimed device structure. Seeing that Shafer discloses the equivalent structure and stimulation parameters as evidenced in the rejection of claim 1 above, Examiner submits that Shafer would be capable of delivering the stimulation in a manner that produces the claimed effects above.
Regarding claim 8, Shafer discloses the electrical signal has a frequency between 0.1 Hz and 100 Hz (para. 85).
Regarding claim 9, Shafer discloses the electrical signal has a current between 0.01 mA and 10 mA (para. 85).
Regarding claim 11, Shafer discloses a detector for detecting one or more signals indicative of one or more physiological parameters; determining from the one or more signals one or more physiological parameters; determining the one or more physiological parameters indicative of worsening of the physiological parameter; and causing the signal to be applied to the pancreas-related sympathetic nerve via the at least one electrode (para. 9, last 3 sentences; para. 107; para. 109).
Regarding claim 12, Shafer discloses the signal generator is configured to apply the electric signal for a finite period of time (para. 109 discloses enabling/disabling therapy delivery circuit based on sensed signals).
Regarding claim 13, Shafer discloses a method of reversibly modulating neural activity in a pancreas-related sympathetic nerve, wherein the pancreas-related sympathetic nerve supplies a lymphatic system of the pancreas and is located adjacent to a gastroduodenal artery or branch thereof, comprising: (i) implanting in a subject a device or system of claim 1; (ii) positioning the electrode in contact with the pancreas-related sympathetic nerve; and (iii) activating the device or system (para. 56).
Regarding claim 14, Shafer discloses the method is for treating type 1 diabetes (T1D) (para. 44).
Regarding claim 15, Shafer discloses administering GABA, a GABA analogue, or a GABA-enhancing agent to the subject (para. 98).
Regarding claim 17, Shafer discloses a method of controlling a device or system comprising at least one electrode, suitable for placement on or around a pancreas-related sympathetic nerve of a subject, wherein the pancreas related sympathetic nerve supplies a lymphatic system of the pancreas, and a signal generator for generating a signal to be applied to the pancreas-related sympathetic nerve via the at least one electrode such that the signal reversibly modulates the neural activity of the pancreas-related sympathetic nerve to produce a change in a physiological parameter in the subject, the method comprising the steps of: implanting the electrode within the subject at a location on or around the pancreas related sympathetic nerve of the subject at a location adjacent to a gastroduodenal artery or branch thereof, sending control instructions to the device or system, and applying the signal to the pancreas-related sympathetic nerve in response to the control instructions, wherein the change in the physiological parameter is an increase in catecholamine levels in the pancreas, an increase in GABA levels in the pancreas, and an increase in the number of pancreatic beta cells in the pancreas (see rejection of claim 1 above).
Regarding claim 18, Shafer discloses a method of controlling a device or system comprising at least one electrode, suitable for placement on or around a pancreas-related sympathetic nerve of a subject, wherein the pancreas related sympathetic nerve supplies a lymphatic system of the pancreas, and a signal generator for generating a signal to be applied to the pancreas-related sympathetic nerve via the at least one electrode such that the signal reversibly modulates the neural activity of the pancreas- related sympathetic nerve to produce a change in a physiological parameter in the subject, the method comprising the steps of: implanting the electrode within the subject at a location on or around the pancreas related sympathetic nerve of the subject at a location adjacent to a gastroduodenal artery or branch thereof, sending control instructions to the device or system, and applying the signal to the pancreas-related sympathetic nerve in response to the control instructions, wherein the change in the physiological parameter is at least two of the group consisting of: an increase in catecholamine levels in the pancreas, an increase in GABA levels in the pancreas, and an increase in the number of pancreatic beta cells in the pancreas (see rejection of claim 1 above).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shafer in view of Ben-Ezra et al. (US 2014/0046407) (hereinafter Ben-Ezra).
Regarding claim 10, Shafer does not disclose the electrical signal is a charge-balanced DC signal comprising a cathodic pulse and an anodic pulse.
Ben-Ezra, however, teaches nerve stimulation techniques (Abstract) wherein in some embodiments of the present invention, the efferent and afferent anode sets each comprise exactly one electrode, which are directly electrically coupled to each other. The cathodic current is applied with an amplitude sufficient to induce action potentials in large- and medium-diameter fibers (e.g., A- and B-fibers), but insufficient to induce action potentials in small-diameter fibers (e.g., C-fibers). Simultaneously, an anodal current is applied in order to inhibit action potentials induced by the cathodic current in the large-diameter fibers (e.g., A-fibers), but not in the small- and medium-diameter fibers (e.g., B- and C-fibers). This combination of cathodic and anodal current generally results in the stimulation of medium-diameter fibers (e.g., B-fibers) only (para. 490).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Shafer such that the electrical signal is a charge-balanced DC signal comprising a cathodic pulse and an anodic pulse. Making this modification would be useful for stimulation of medium-diameter fibers (e.g., B-fibers) only, as taught by Ben-Ezra.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shafer in view of Yun et al. (US 2018/0125419) (hereinafter Yun).
Regarding claim 16, Shafer does not disclose the GABA-enhancing agent is selected from the group consisting of benzodiazepines; barbituates; baclofen; acamprosate; pregabalin; gabapentin; tiagabine; lamotrigine; topiramate; neuroactive steroids; nabiximols; and combinations thereof.
Yun, however, teaches administering a GABA-enhancing agent to the subject (para. 30-31 discloses use of phenobarbital, a known barbiturate) as a known enhancement pharmaceutical to a subject treatment (para. 27-28), for the purpose of enhancing or diminishing symptoms of a disease condition (para. 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Shafer such that the GABA-enhancing agent is a barbiturate such as phenobarbital. Making this modification would be useful for diminishing symptoms of a disease condition, as taught by Yun.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anant A Gupta whose telephone number is (571)272-8088. The examiner can normally be reached Mon-Fri 9 am - 5 pm ET.
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, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.A.G./Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796