DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of US Application no. 17/107,101, now US Patent no. 11,890,472, filed 30 November 2020, which is a continuation of US Application no. 16/167,958, now abandoned, filed 23 October 2018, which is a continuation of US Application no. 15/688,546, now US Patent no. 10,105,541, filed 28 August 2017, which is a continuation of US Application no. 15/231,555, now US Patent no. 9,744,360, filed 8 August 2016, which is a continuation of US Application no. 14/726,359, now US Patent no. 9,409,021, filed 29 May 2015, which is a division of US Application no. 12/607,009, now US Patent no. 9,056,197, filed 27 October 2009, which claims the benefit of priority of US Provisional Application no. 61/,108,836, filed 27 October 2008.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-4 and 7 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Kim et al. (US Publication no. 7,337,005 – disclosed by Applicant).
In regard to claims 1-3 and 7, Kim et al. discloses a method for stimulating a portion of the dorsal root ganglion using an implantable electrode system. The electrode is advanced epidurally (col 13 lines 6-21, col 32 lines 26-29) to the dorsal root ganglion, and supplies selective electrical stimulation to treat pain (col 7 line 56 - col 8 line 8, and col 8 lines 28-44). The stimulation is described as being selective since the stimulation only modulates the dorsal root ganglion without stimulation of the surrounding neural tissue and leaving the nearby motor nerves unstimulated (col 7 lines 60-67 and col 8 lines 28-44).
In regard to claim 4, the stimulation of Kim et al. can stimulate specific dermatomes to treat a specific area of pain (col 6 lines 61-65, col 7 lines 2-7, col 9 lines 45-47, col 11 lines 9-26).
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 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 negated by the manner in which the invention was made.
Claims 5 and 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kim et al. (US Publication no. 7,337,005 – disclosed by Applicant) in view of Rutekci et al. (US Patent no. 5,330,515 – disclosed by Applicant).
In regard to claims 5 and 6, Kim et al. is considered to substantially describe the invention as claimed, including selective electrical stimulation of the dorsal root ganglion to treat pain wherein the stimulation only modulates the dorsal root ganglion and leaves the nearby motor nerves unstimulated (col 8 lines 28-44). Kim et al. does not teach that the current amplitude of the stimulation is less than 4 mA, or preferably less than 1 mA. Kim et al. does make suggestion that 1 mA with a 1 mm² surface area electrode may be used to create effective current density to stimulate the target tissue (col 7 lines 9-25). This disclosure is considered suggestive that Kim et al. contemplated stimulating the tissue utilizing 1 mA current amplitude. However, it is not clear from the reference if Kim et al. suggests that 1 mA is actually applied. Rutecki et al. describes a method for treating pain using electro neurostimulation, wherein the stimulation enhances dorsal root activity (col 7 lines 19-22). Rutecki et al. teach that stimulation parameters for selection generally depend on the needs of the individual, suggesting that routine experimentation within a general range is required in order to determine the optimal effective stimulation parameters (col 12 lines 23-27). Rutecki et al. provides a table that teaches the general range, and the typical range of result effective parameters (col 12 lines 30-40). The table teaches that the typical range for current amplitude that treats pain is within the range of 0.5-3.0 mA, which is considered to satisfy the requirements of claims 5 and 6. Rutecki et al. is relied on to teach general working ranges effective for enhancing dorsal root activity and treating pain that one of ordinary skill in the art would find obvious to try. Further, discovering the optimum range or optimal value of a result effective variable has been to be obvious to those of ordinary skill in the art since it only involves routine skill and experimentation for discovery. In re Boesche, 617 F.2d, 272 205 USPQ 215 (CCPA 198C) and In re Aller, 105 USPQ 233.
Further, discovering the optimum range or optimal value of a result effective variable has been to be obvious to those of ordinary skill in the art since it only involves routine skill and experimentation for discovery. In re Boesche, 617 F.2d, 272 205 USPQ 215 (CCPA 198C) and In re Aller, 105 USPQ 233.
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 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,890,472. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘472 reference anticipates the present invention since it recites each and every limitation of the claimed invention. For instance, claim 1 in view of claim 2 of the ‘472 patent recites the features of a method of treating a patient, wherein the condition is associated with a dorsal root ganglion that is not substantially associated with other portions of the dorsal root ganglion comprising: positioning a lead in proximity to a dorsal root ganglion, and providing a stimulating signal that stimulates the dorsal root ganglion in a manner that affects the condition while not substantially stimulating other portions (claim 2 of the ‘472 recites that the stimulation alleviates pain without causing a perceptible motor response which is considered to anticipate the claimed limitation for not substantially stimulation the other portions of the dorsal root ganglion; additionally claim 2 of the ‘472 anticipates present claim 3). The recitation of elements in the ‘472 reference described above is considered to create an overlap of features, such that the inventions are not considered mutually exclusive nor patentably distinct.
Claims 1-4 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,105,541. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘541 reference anticipates the present invention since it recites each and every limitation of the claimed invention. For instance, claim 1 in view of claim 5 of the ‘541 patent recites the features of a method of treating a patient, wherein the condition is associated with a dorsal root ganglion that is not substantially associated with other portions of the dorsal root ganglion comprising: positioning a lead in proximity to a dorsal root ganglion, and providing a stimulating signal that stimulates the dorsal root ganglion in a manner that affects the condition while not substantially stimulating other portions (claim 5 of the ‘541 recites that he stimulation alleviates pain without causing a perceptible motor response which is considered to anticipate the claimed limitation for not substantially stimulation the other portions of the dorsal root ganglion). Additionally, elements of claim 1 of the ‘541 anticipate present claim 2 for treating pain and anticipate present claim 7 for epidural delivery. Claims 2-4 of the ‘541 anticipate claim 4 of the present invention for targeting dermatomes. The recitation of elements in the ‘541 reference described above is considered to create an overlap of features, such that the inventions are not considered mutually exclusive nor patentably distinct.
Claims 1-7 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,744,360. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘360 reference anticipates the present invention since it recites each and every limitation of the claimed invention. For instance, claim 1 of the ‘360 reference recites the features of a method of treating a patient, wherein the condition is associated with a dorsal root ganglion that is not substantially associated with other portions of the dorsal root ganglion comprising: positioning a lead in proximity to a dorsal root ganglion, and providing a stimulating signal that stimulates the dorsal root ganglion in a manner that affects the condition while not substantially stimulating other portions. Further, claims 2, 3, 4, and 5 of the '360 recite the features respectively of claims 2, 3, 4, and 7 of the present invention. The recitation of elements in the ‘360 reference described above is considered to create an overlap of features, such that the inventions are not considered mutually exclusive nor patentably distinct.
Claims 1-7 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,409,021. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘021 reference anticipates the present invention since it recites each and every limitation of the claimed invention. For instance, claim 1 of the ‘021 reference recites the features of a method of treating a patient, wherein the condition is associated with a dorsal root ganglion that is not substantially associated with other portions of the dorsal root ganglion comprising: positioning a lead in proximity to a dorsal root ganglion, and providing a stimulating signal that stimulates the dorsal root ganglion in a manner that affects the condition while not substantially stimulating other portions. Further, claims 2, 3, 4, and 5 of the '021 recite the features respectively of claims 2, 3, 4, and 7 of the present invention. The limitations of claims 5 and 6 of the present invention are considered obviated by claim 1 of the '021 reference, such that claim 1 of the '021 teaches stimulation amplitudes under 4 mA and 1 mA. The recitation of elements in the ‘021 reference described above is considered to create an overlap of features, such that the inventions are not considered mutually exclusive nor patentably distinct.
Claims 1, 2, 5, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-20 of U.S. Patent No. 9,056,197. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘197 reference anticipates the present invention since it recites each and every limitation of the claimed invention. For instance, claim 15 of the ‘197 patent recites the features of a method of treating a patient, wherein the condition is associated with a dorsal root ganglion that is not substantially associated with other portions of the dorsal root ganglion comprising (e.g., a ventral root): positioning a lead in proximity to a dorsal root ganglion, and providing a stimulating signal that stimulates the dorsal root ganglion in a manner that affects the condition while not substantially stimulating other portions (claim 15 of the ‘197 recites providing a stimulation magnitude to stimulate the target dorsal root ganglion without stimulating a ventral root associated with the dorsal root which considered to anticipate the claimed limitation for not substantially stimulation the other portions of the dorsal root ganglion). Additionally, elements of claim 15 of the ‘197 anticipate present claim 2 for treating pain and anticipate present claim 7 for epidural delivery. Claims 16 and 17 of the ‘197 anticipate claims 5 and 6 of the present invention for applying stimulation amplitudes below 4 mA and below 1 mA . The recitation of elements in the ‘197 reference described above is considered to create an overlap of features, such that the inventions are not considered mutually exclusive nor patentably distinct.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 18 February 2026