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 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 1-20 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.
Claim 1 recites the limitation "any one of the plurality of electrodes" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "each of the plurality of electrodes" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "each of the plurality of electrodes" in line 5. There is insufficient antecedent basis for this limitation in the claim.
NOTE: Claims 1, 15 and 18 do not positively recite the “plurality of electrodes”. Examiner recommends amending the claims to positively recite the plurality of electrodes to overcome the 35 U.S.C. 112 rejection.
Additionally, claims 2 and 19 recite “therapeutic window corresponds to a difference between a maximum tolerable threshold for the electrical stimulation and a perception threshold for the electrical stimulation to cause a patient to perceive delivery of the electrical stimulation”. However, claims 1 and 18 recite “the therapeutic window corresponding to a difference between a first stimulation threshold for electrical stimulation to cause a first physiological effect and a second stimulation threshold for the electrical stimulation to cause a second physiological effect”.
As such, it is unclear how the therapeutic window is determined. By the “difference between a first stimulation threshold for electrical stimulation to cause a first physiological effect and a second stimulation threshold for the electrical stimulation to cause a second physiological effect” (as indicated in independent claims 1 and 18) or by “difference between a maximum tolerable threshold for the electrical stimulation and a perception threshold for the electrical stimulation to cause a patient to perceive delivery of the electrical stimulation” (claims 2 and 19). If the “maximum tolerable threshold” is equivalent to the “first stimulation threshold” and “the perception threshold” is equivalent to the “second stimulation threshold”, the examiner recommends indicating as such to overcome the 35 U.S.C. 112 rejection for claim 2 and 19.
For example, claims 2-3 in the parent application 17/481,127 as provided below:
2. The method of claim 1, wherein the second stimulation threshold is a maximum tolerable threshold for the applied stimulation.
3. The method of claim 1, wherein the first stimulation threshold is a perception threshold for the applied stimulation to cause a patient to perceive delivery of the applied stimulation.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,138,453. Although the claims at issue are not identical, they are not patentably distinct from each other because US 12,138,453 has been found to anticipate each and every element of the present invention, for instance both provide:
18/908,610 (claim 1)
US 12,138,453 (claim 19)
A system for use with a plurality of electrodes in proximity to a nerve root, the system comprising:
A system, comprising: at least one lead including a plurality of electrodes, wherein the at least one lead is configured to be positioned to place the plurality of electrodes in proximity to a nerve root;
a stimulation waveform generator configured to deliver neurostimulation through any one of the plurality of electrodes;
a stimulation waveform generator configured to deliver neurostimulation through any one of the plurality of electrodes;
and a controller configured to:
and a controller programmed to implement a process
determine a therapeutic window for each of the plurality of electrodes,
determining a therapeutic window for each of the plurality of electrodes,
the therapeutic window corresponding to a difference between a first stimulation threshold for electrical stimulation to cause a first physiological effect and a second stimulation threshold for the electrical stimulation to cause a second physiological effect;
wherein for each of the plurality of electrodes determining the therapeutic window includes: applying stimulation using the stimulation waveform generator; determining a first stimulation threshold for the applied stimulation to cause a first physiological effect; determining a second stimulation threshold for the applied stimulation to cause a second physiological effect;
determine a smallest one of the determined therapeutic windows;
and determining a difference between the first stimulation threshold and the second stimulation threshold, wherein the difference is the therapeutic window;
determine one or more of the plurality of electrodes corresponding to the smallest one of the determined therapeutic windows;
determining at least one electrode with a minimum value for the therapeutic window;
and suggest at least one of the plurality of electrodes for use to stimulate the nerve root based on the determined one or more of the plurality of electrodes corresponding to the smallest one of the determined therapeutic windows.
and suggesting the at least one electrode to be used to stimulate the nerve root based on the determined at least one electrode with the minimum value.
As set forth above, the present invention is not viewed to be patentably distinct from US 12,138,453 B2.
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 and 7-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hershey et al. (US Patent Publication 20160082268 A1).
As to claims 1, 15 and 18, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses a system for use with a plurality of electrodes (Figure 7; [0067]) in proximity to a nerve root ([0008, 0026-0028, 0074, 0083]; Figures 12 and 19; Claims 1 and 5), the system comprising: a stimulation waveform generator (pulse generator, depicted as 726 in Figure 7; [0067-0069]) configured to deliver neurostimulation through any one of the plurality of electrodes ([0069]); and a controller (microcontroller; [0067]) configured to: determine a therapeutic window for each of the plurality of electrodes (Figure 19), the therapeutic window corresponding to a difference between a first stimulation threshold for electrical stimulation to cause a first physiological effect (Figure 19; Claims 1-5; [0077, 0084, 0086, 0088, 0099-0104]) and a second stimulation threshold for the electrical stimulation to cause a second physiological effect (Figure 19; Claims 1-5; [0077, 0086, 0088, 0099-0104]); determine a smallest one of the determined therapeutic windows (Figure 19; Claims 1-5; [0086, 0088, 0099-0104]); determine one or more of the plurality of electrodes corresponding to the smallest one of the determined therapeutic windows ([0069, 0080, 0084, 0090-0091]; "The IPG may be operated in a mode to deliver electrical modulation energy that is therapeutically effective and causes the patient to perceive delivery of the energy (e.g. therapeutically effective to relieve pain with perceived paresthesia), and may be operated in a sub-perception mode to deliver electrical modulation energy that is therapeutically effective and does not cause the patient to perceive delivery of the energy (e.g. therapeutically effective to relieve pain without perceived paresthesia)." [0068]; "sub-perception" is considered the minimum value); and suggest at least one of the plurality of electrodes for use to stimulate the nerve root based on the determined one or more of the plurality of electrodes corresponding to the smallest one of the determined therapeutic windows (Figure 19).
As to claims 2 and 19, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses the therapeutic window corresponds to a difference between a maximum tolerable threshold for the electrical stimulation and a perception threshold (Figure 19; Claims 1-5; [0086, 0088, 0099-0104]) for the electrical stimulation to cause a patient to perceive delivery of the electrical stimulation ([0079]).
As to claims 3 and 20, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses at least one of the first physiologic effect or the second physiologic effect is detected using at least one sensor configured to sense at least one physiological response ([0007]).
As to claim 4, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses the sensor includes a nerve activity sensor ([0086]).
As to claim 7, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses the at least one sensor is configured to sense an evoked response, the controller being configured to estimate a perception threshold using a relationship between the perception threshold and the evoked response ([0079, 0086]).
As to claim 8, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses the electrical stimulation includes cathodic monopolar stimulation ([0067-0068, 0072]).
As to claim 9, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses the electrical stimulation includes anodic monopolar stimulation ([0067-0068, 0072]).
As to claim 10, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses the first stimulation threshold and the second stimulation threshold correspond to different amplitudes for the electrical stimulation ([0067-0069, 0077, 0083]).
As to claims 11 and 16, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses the first stimulation threshold and the second stimulation threshold correspond to at least one of different frequencies, different pulse widths, or different time varying patterns for the electrical stimulation ([0083]; Figure 19).
As to claims 12 and 17, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses at least one of the plurality of electrodes is medial to the determined at least one of the plurality of electrodes corresponding to the smallest one of the determined therapeutic windows ([0072, 0075-0077; Figure 10]).
As to claim 13, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses programming a neurostimulator to deliver stimulation to the suggested at least one electrode ([0004]).
As to claim 14, as best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses the electrical stimulation is cathodic stimulation ([0054, 0067-0068]); and the difference being between a comfort threshold ([0068]; "The IPG may be operated in a mode to deliver electrical modulation energy that is therapeutically effective and causes the patient to perceive delivery of the energy (e.g. therapeutically effective to relieve pain with perceived paresthesia), and may be operated in a sub-perception mode to deliver electrical modulation energy that is therapeutically effective and does not cause the patient to perceive delivery of the energy (e.g. therapeutically effective to relieve pain without perceived paresthesia)": The sub-perception threshold is considered the "comfort threshold".) corresponding to a first amplitude for the cathodic stimulation and a perception threshold ([0079]) corresponding to a second amplitude for the cathodic stimulation ([0054, 0068-0069, 0077]; Figures 18-19).
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.
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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hershey et al. (US Patent Publication 20160082268 A1).
As best understood in light of the rejections under 35 U.S.C. 112 above, Hershey et al. discloses the invention substantially as claimed with a sensor for sensing physiological parameters but does not explicitly disclose a muscle activity sensor such as an accelerometer or an electromyogram sensor. Accelerometer and electromyogram sensors are extremely well known in the medical device art for monitoring patient physical activity as well as periods of rest. As such, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the types of sensors employed by Hershey et al. to include muscle activity sensors, such as an accelerometer or an electromyogram sensor, in order to provide the predictable result of providing comprehensive patient data in order to best optimize the patient treatment to meet specific patient therapeutic needs and requirements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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