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 .
Response to Amendment
The preliminary amendment filed January 6, 2025 has been entered. Claims 1-15 are canceled. Claims 16-22 are new and currently pending for examination.
Specification
The disclosure is objected to because of the following informalities: paragraph [0001] should be updated to reflect the U.S. Patent numbers of the parent applications.
Appropriate correction is required.
Claim Objections
Claim 16 is objected to because of the following informalities: lines 9-10 recite, “applying a charge density per phase applied to the one or more nerves by the electrical signal is between 5 µC to 1100 µC per cm2 per phase” which does not appear to be grammatically correct. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,161,869. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely the computer-implemented method corresponding to the patented system claims, and broader in scope than the patented claims.
Application claim 16 is directed to a computer-implemented method for treating a medical condition involving stimulating neural activity of one or more nerves adjacent to a splenic arterial loop. While patented claim 1 is directed to a system for stimulating the neural activity of a splenic arterial nerve…at a site where the splenic artery is not in direct contact with the pancreas, applicant’s own specification admits, “This new way involves applying electrical signals to splenic arterial nerves at sites where the splenic artery is not in direct contact with the pancreas. For example, the splenic artery, which runs along the surface of the pancreas, is generally in direct contact with the pancreas, but separates at certain positions from the surface of the pancreas in loop-like structures (herein referred to as splenic arterial loops). The splenic arterial loops are therefore particularly advantageous sites for applying electrical signal to modulate the neural activity of the splenic arterial nerves.” ([0011]). Therefore the application claim 16’s recitation of “splenic arterial loop” is equivalent to the patented claim 1’s recitation of “at a site where the splenic artery is not in direct contact with the pancreas.
Application claim 16 further recites controlling at least one electrode… to apply an electrical signal… wherein the electrical signal has a waveform that comprises one or more pulse trains. Patented claim 4 recites the electrical signal of patented claim 1 comprises a pulse train. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that an electrical signal would be delivered as a waveform comprising one or more pulse trains as it is a known neural electrical signal shape, the results of such a modification being reasonably predictable. Application claim 16 also recites limitations of applying a charge density per phase applied to the one or more nerves by the electrical signal is between 5 µC to 1100 µC per cm2 per phase, wherein the electrical signal produces an improvement in a physiological parameter in a subject consisting of a specific group which is recited by patented claim 1.
Application claims 17-18 generally corresponds to patented claims 2 and 3, respectively.
Claims 19, 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of U.S. Patent No. 12,161,869 in view of O’Connor et al. (US 2012/0277828).
Regarding claim 19 requires the step of sending a set of control instructions that are performed by software in a machine readable form from a tangible storage medium. O’Connor et al. teaches it is known in the art for a programmer 122 to send a set of control instructions for performing by software in a machine readable form to a tangible storage medium ([0061]). 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 patented claim 1 with the teachings of O’Connor et al. as it is a known method of sending a set of control instructions for performing by software in a machine readable form to a tangible storage medium, the results of such a modification being reasonably predictable.
Regarding claims 21-22, O’Connor et al. teaches a remote computer 122 for providing a set of control instructions that were located on the remote computer ([0061]). 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 patented claim 1 with the teachings of O’Connor et al. as it is a known method of providing a remote computer and providing a set of control instructions that are located on the remote computer, the results of such a modification being reasonably predictable.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of U.S. Patent No. 12,161,869 in view of O’Connor et al. (US 2012/0277828) and Melodia et al. (US 2018/0027077).
Regarding claim 20, Melodia et al. teaches parallel processors are known processors for carrying out tasks in a neurostimulation system ([0176]). 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 patented claim 1 with the teachings of Melodia et al. as parallel processors are a known processing type, the results of such a modification being reasonably predictable.
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,738,196. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely the computer-implemented method corresponding to the patented system claims, and broader in scope than the patented claims.
Application claim 16 is directed to a computer-implemented method for treating a medical condition involving stimulating neural activity of one or more nerves adjacent to a splenic arterial loop. While patented claim 1 is directed to a system for stimulating the neural activity of a splenic arterial nerve…at a site where the splenic artery is not in direct contact with the pancreas, applicant’s own specification admits, “This new way involves applying electrical signals to splenic arterial nerves at sites where the splenic artery is not in direct contact with the pancreas. For example, the splenic artery, which runs along the surface of the pancreas, is generally in direct contact with the pancreas, but separates at certain positions from the surface of the pancreas in loop-like structures (herein referred to as splenic arterial loops). The splenic arterial loops are therefore particularly advantageous sites for applying electrical signal to modulate the neural activity of the splenic arterial nerves.” ([0011]). Therefore the application claim 16’s recitation of “splenic arterial loop” is equivalent to the patented claim 1’s recitation of “at a site where the splenic artery is not in direct contact with the pancreas.
Application claim 16 further recites controlling at least one electrode… to apply an electrical signal… wherein the electrical signal has a waveform that comprises one or more pulse trains. Patented claim 4 recites the electrical signal of patented claim 1 comprises a pulse train. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that an electrical signal would be delivered as a waveform comprising one or more pulse trains as it is a known neural electrical signal shape, the results of such a modification being reasonably predictable. Application claim 16 also recites limitations of applying a charge density per phase applied to the one or more nerves by the electrical signal is between 5 µC to 1100 µC per cm2 per phase, wherein the electrical signal produces an improvement in a physiological parameter in a subject consisting of a specific group which is recited by patented claim 1.
Application claims 17-18 generally corresponds to patented claims 2 and 3, respectively.
Claims 19, 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of U.S. Patent No. 11,738,196 in view of O’Connor et al. (US 2012/0277828).
Regarding claim 19 requires the step of sending a set of control instructions that are performed by software in a machine readable form from a tangible storage medium. O’Connor et al. teaches it is known in the art for a programmer 122 to send a set of control instructions for performing by software in a machine readable form to a tangible storage medium ([0061]). 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 patented claim 1 with the teachings of O’Connor et al. as it is a known method of sending a set of control instructions for performing by software in a machine readable form to a tangible storage medium, the results of such a modification being reasonably predictable.
Regarding claims 21-22, O’Connor et al. teaches a remote computer 122 for providing a set of control instructions that were located on the remote computer ([0061]). 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 patented claim 1 with the teachings of O’Connor et al. as it is a known method of providing a remote computer and providing a set of control instructions that are located on the remote computer, the results of such a modification being reasonably predictable.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of U.S. Patent No. 11,738,196 in view of O’Connor et al. (US 2012/0277828) and Melodia et al. (US 2018/0027077).
Regarding claim 20, Melodia et al. teaches parallel processors are known processors for carrying out tasks in a neurostimulation system ([0176]). 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 patented claim 1 with the teachings of Melodia et al. as parallel processors are a known processing type, the results of such a modification being reasonably predictable.
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,446,496. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely the computer-implemented method corresponding to the patented system claims, and broader in scope than the patented claims.
Application claim 16 is directed to a computer-implemented method for treating a medical condition involving stimulating neural activity of one or more nerves adjacent to a splenic arterial loop. While patented claim 1 is directed to a system for stimulating the neural activity of a splenic arterial nerve…at a site where the splenic artery is not in direct contact with the pancreas, applicant’s own specification admits, “This new way involves applying electrical signals to splenic arterial nerves at sites where the splenic artery is not in direct contact with the pancreas. For example, the splenic artery, which runs along the surface of the pancreas, is generally in direct contact with the pancreas, but separates at certain positions from the surface of the pancreas in loop-like structures (herein referred to as splenic arterial loops). The splenic arterial loops are therefore particularly advantageous sites for applying electrical signal to modulate the neural activity of the splenic arterial nerves.” ([0011]). Therefore the application claim 16’s recitation of “splenic arterial loop” is equivalent to the patented claim 1’s recitation of “at a site where the splenic artery is not in direct contact with the pancreas.
Application claim 16 further recites controlling at least one electrode… to apply an electrical signal… wherein the electrical signal has a waveform that comprises one or more pulse trains. Patented claim 4 recites the electrical signal of patented claim 1 comprises a pulse train. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that an electrical signal would be delivered as a waveform comprising one or more pulse trains as it is a known neural electrical signal shape, the results of such a modification being reasonably predictable. Application claim 16 also recites limitations of applying a charge density per phase applied to the one or more nerves by the electrical signal is between 5 µC to 1100 µC per cm2 per phase which comprises overlapping ranges with the patented claim. Application claim 16 recites wherein the electrical signal produces an improvement in a physiological parameter in a subject consisting of a specific group which is recited by patented claim 1.
Application claims 17-18 generally corresponds to patented claims 2 and 3, respectively.
Claims 19, 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of U.S. Patent No. 11,446,496 in view of O’Connor et al. (US 2012/0277828).
Regarding claim 19 requires the step of sending a set of control instructions that are performed by software in a machine readable form from a tangible storage medium. O’Connor et al. teaches it is known in the art for a programmer 122 to send a set of control instructions for performing by software in a machine readable form to a tangible storage medium ([0061]). 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 patented claim 1 with the teachings of O’Connor et al. as it is a known method of sending a set of control instructions for performing by software in a machine readable form to a tangible storage medium, the results of such a modification being reasonably predictable.
Regarding claims 21-22, O’Connor et al. teaches a remote computer 122 for providing a set of control instructions that were located on the remote computer ([0061]). 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 patented claim 1 with the teachings of O’Connor et al. as it is a known method of providing a remote computer and providing a set of control instructions that are located on the remote computer, the results of such a modification being reasonably predictable.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of U.S. Patent No. 11,446,496 in view of O’Connor et al. (US 2012/0277828) and Melodia et al. (US 2018/0027077).
Regarding claim 20, Melodia et al. teaches parallel processors are known processors for carrying out tasks in a neurostimulation system ([0176]). 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 patented claim 1 with the teachings of Melodia et al. as parallel processors are a known processing type, the results of such a modification being reasonably predictable.
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.
Claim 19 is 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. The wording of this claim is indefinite because, based on the phrasing “on a tangible storage medium”, it is unclear if the limitation requires sending the set of control instructions that are performed by software in a machine readable form to a tangible storage medium, or from a tangible storage medium. Paragraph [0026] of the published application states “a step of sending control instructions to the system” and paragraph [0227] states, “The methods described herein may be performed by software in machine readable form on a tangible storage medium” but neither cited portions of the specification link together, “sending a set of control instructions… on a tangible storage medium”. For purposes of examination, this claim will be interpreted as, “sending a set of control instructions… to a tangible storage medium”.
Conclusion
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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