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.
Claim 6 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 terms “regular” and “irregular” in claim 6 are relative terms which renders the claim indefinite. The terms “regular” and “irregular” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what would be considered “regular” in the sense of a pattern or “irregular”. Does this pertain to even spacing amongst electrodes or is this stating that some sort of pattern is repeated or not repeated? For the purposes of examination, the Examiner will interpret these terms and relating to even spacing and uneven spacing.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2, 4-9, 14, 15, 17-21 and 24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by King et al. (2009/0281596).
In regard to Claims 2, 4, 15 and 17, King discloses a method of implanting a stimulator 14 having a first and second lead 152, 154 coupled thereto (par. [0055, 0136]; Fig. 9A-B. The leads are placed on different sides of a target tissue (e.g. a peripheral nerve target) and a stimulus is delivered from one lead to the other so that the stimulus traverses and stimulates the target peripheral nerve (par. [0005-0009; 0063-0064, 0074, 0133; Fig. 9A-B).
In regard to Claims 5, 6 and 18, King discloses each lead has a plurality of electrodes 156a-d; 158a-d (par. [0136]). King further discloses the electrodes are regularly spaced and thus would form a regular pattern (Fig. 9B, 10B, 12C)
With regard to Claims 7 and 19, King discloses the electrodes can be selected to deliver a desired electric field shape, pattern, strength etc. (par. [0068, 0120, 0133]; Fig. 6-8).
In regard to Claims 8, 9, 20 and 21, King discloses that stimulation waveforms are generated having adjustable parameters (such as frequency, amplitude, etc.) that can achieve the desired stimulation vectors (par. [0009, 0077-0078, 0081, 0097, 0100, 0120]).
Regarding Claims 14 and 24, King discloses the leads can be a bifurcated lead with an end that can fit into a single port (par. [0059]).
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 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (2009/0281596).
Regarding Claims 3 and 16, King discloses providing a separation distance between first and second leads but fails to disclose the exact distance of separation. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a separation distance of 10-50 cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 10 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (2009/0281596), herein King ‘596, in view of King et al. (2009/0281594), herein King ‘594.
Regarding Claims 10 and 22, King ‘596 discloses applying peripheral nerve stimulation to alleviate pain in a patient but fails to disclose adjusting stimulation parameters based on sensed physiological sensors. However, King ‘594 discloses using sensing modules to detect physiological parameters and adjusting stimulation based on those parameters (Abstract; par. [0042-0047]) for the purpose of providing quick and effective adjustments to stimulation to adjust pain perception without the need of a physician. Therefore 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 device in the King ‘596 reference to include sensing physiological signals and controlling stimulation based on the sensed signals, as taught and suggested by King ‘594, for the purpose of providing quick and effective adjustments to stimulation to adjust pain perception without the need of a physician.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over King et al. (2009/0281596) in view of Mickle et al. (2009/0105782).
Regarding Claim 11, King discloses all of the claimed invention except for a wireless power source for wirelessly powering the implantable device during stimulation. However, in the same field of endeavor of implantable nerve stimulation devices, Mickle discloses providing power wirelessly to the implantable device for the purpose of reducing implant size due to bulky batteries (Abstract; par. [0004]). Therefore 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 device in the King reference to include wirelessly powering the implant, as taught and suggested by Mickle, for the purpose of reducing implant size due to bulky batteries.
Claims 12 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (2009/0281596) in view of Venook et al. (2014/0135614).
In regard to Claims 12 and 23, King discloses all of the claimed invention except for using MRI compatible leads. However, in the same field of endeavor of implantable electrical nerve stimulation devices, Venook discloses incorporating dummy coils into an implantable lead for the purpose of reducing and/or distributing current induced by MRI fields during an MRI procedure thus protecting the patient from overheating of the electrical components (Abstract; par. [0001-0005]). Therefore 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 device in the King reference to include dummy coils in the leads, as taught and suggested by Venook, for the purpose of of reducing and/or distributing current induced by MRI fields during an MRI procedure thus protecting the patient from overheating of the electrical components.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over King et al. (2009/0281596) in view of Sage et al. (2012/0232625).
Regarding Claim 13, King a housing that is positioned proximal the first and second leads but fails to explicitly mention whether the housing is sealed. However, Sage discloses, as is well-known and well-established in the art of implantable stimulators, that the housing is hermetically sealed for the purpose of preventing bodily fluids from ingress into the housing where the electrical circuitry is located (par. [0036]). Therefore 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 device in the King reference to include sealing the housing, as taught and suggested by Sage, for the purpose of preventing bodily fluids from ingress into the housing where the electrical circuitry is located.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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, Unsu Jung can be reached at 571-272-8506. 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.
/ALLEN PORTER/Primary Examiner, Art Unit 3796
Prosecution Insights