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 .
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1-4, 10-13, and 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schuttler et al (US Publication 2019/0060641).
Referring to Claim 1, Schuttler et al teaches an implantable neuromodulation device for receiving a nerve, the device comprising: a chamber having a cross-sectional chamber inner dimension (e.g. Figure 2, Element 50); at least one electrode disposed in the chamber (e.g. Figure 2, Element 60); a non-linear channel having a proximal end and a distal end, the proximal end being open to outside of the device and the distal end terminating at the chamber (e.g. Figure 2, channel between 30 and 83), the non-linear channel fluidly connecting an interior of the chamber with an exterior of the neuromodulation device such that the chamber is fluidly connected to the exterior of the neuromodulation device (e.g. Figure 2, channel between 30 and 83), the non-linear channel having a cross-sectional channel inner dimension at the distal end, wherein the cross-sectional channel inner dimension at the distal end is less than the cross-sectional chamber inner dimension (e.g. Figure 2), the non-linear channel being defined by first and second opposing walls (e.g. Figure 2, elements 30 and 40), the non-linear channel having a centerline positioned equidistant between the first and second opposing walls and extending from the proximal end to the distal end, the centerline changing direction from the proximal end to the distal end (e.g. Figure 2).
Referring to Claims 2 and 11, Schuttler et al teaches the claimed implantable neuromodulation device of claim 1, wherein the cross-sectional channel inner dimension is between 50 to 5000 micrometers (e.g. Figures 1 and 2 and Paragraph [0010] discloses the cuff is suitable for thinner nerves (e.g. smaller than 1000 micrometers)).
Referring to Claims 3 and 12, Schuttler et al teaches the claimed implantable neuromodulation device, wherein the non-linear channel is shaped to require that passing a nerve through the non-linear channel from the proximal end to the chamber requires changing direction (e.g. Figure 2).
Referring to Claims 4 and 13, Schuttler et al teaches the claimed implantable neuromodulation device, wherein the at least one electrode is configured to at least one of record or apply electrical impulses (e.g. Figure 2, Element 60 and Paragraphs [0003] and [0071]).
Referring to Claim 10, Schuttler et al teaches an implantable neuromodulation device for receiving a nerve, the device comprising: a chamber having a cross-sectional chamber inner dimension (e.g. Figure 2, Element 50); at least one electrode disposed in the chamber (e.g. Figure 2, Element 60); a non-linear channel having a proximal end and a distal end, the proximal end being open to outside of the device and the distal end terminating at the chamber (e.g. Figure 2, channel between 30 and 83), the non-linear channel fluidly connecting an interior of the chamber with an exterior of the neuromodulation device such that the chamber is fluidly connected to the exterior of the neuromodulation device (e.g. Figure 2, channel between 30 and 83), the non-linear channel having a cross-sectional channel inner dimension at the distal end, wherein the cross-sectional channel inner dimension at the distal end is less than the cross-sectional chamber inner dimension (e.g. Figure 2), the non-linear channel being defined by first and second opposing walls (e.g. Figure 2, elements 30 and 40), the non-linear channel having a centerline positioned equidistant between each of the first and second opposing walls and extending from the proximal end to the distal end, the non-linear channel comprising one or more turns, curves, or bends (e.g. Figure 2).
Referring to Claim 21, Schuttler et al teaches the implantable neuromodulation device of claim 10, wherein the non-linear channel comprises an “L” shape (e.g. Figure 2).
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.
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.
Claim(s) 5-9, and 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuttler et al (US Publication 2019/0060641) in view of Wei et al (US Publication 2012/0197356).
Referring to Claims 5-9, 14-16 and 18-19, Schuttler et al teaches an implantable neuromodulation device for receiving a nerve (e.g. Figure 2); and discloses the inner side of the nerve cuff are provided with electrical contacts which allow for electrically influencing the natural nerve activity (e.g. Paragraph [0003]). However Schuttler et al does not disclose a stimulation generator configured to provide an electrical pulse to the at least one electrode; wherein the at least one electrode is configured to apply an electrical stimulation having an amplitude between 9.5 microAmps to 20 milliAmps; wherein the at least one electrode is configured to apply an electrical stimulation having a voltage of between 0.1-10 V; wherein the at least one electrode is configured to apply an electrical stimulation having a pulse with a duration between 20-500 microseconds; wherein the at least one electrode is configured to apply an electrical stimulation at a frequency between 0.5 to 50 KHz, wherein the electrical stimulation is received from the stimulation generator.
Wei et al teaches that it is known to use nerve cuffs electrode (e.g. Paragraph [0033]) connected to a stimulation generator (e.g. Paragraph [0030]) for applying a sustained electrical stimulation comprising a frequency of approximately 1-50 kHz and as set forth in Paragraphs [0059] and [0079], an amplitude between about 9.5 microAmps-20 milliAmps and a voltage between about 0.1-10 V as set forth in Paragraph [0084], and a duration of between about 100-500 microseconds as set forth in Paragraph [0085] to provide sufficient electrical stimulation to treat urinary incontinence (Paragraph [0022]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Schuttler et al, with a stimulation generator configured to provide an electrical pulse to the at least one electrode which applies a sustained electrical stimulation comprising a frequency of approximately 1-50 kHz and, an amplitude between about 9.5 microAmps-20 milliAmps and a voltage between about 0.1-10 V, and a duration of between about 100-500 microseconds as taught by Wei et al, since such a modification would provide the predictable results of sufficient electrical stimulation to treat urinary incontinence.
Referring to Claim 17, Schuttler et al in view of Wei et al teaches the implantable neuromodulation device of claim 14, except wherein the at least one electrode is configured to apply an electrical stimulation having at least one of a square, monopolar, cathodic, or bipolar balanced shape, wherein the electrical stimulation is received from the stimulation generator. Wei et al teaches that it is known to use applying cathodic electrical as set forth in Paragraph [0077] to provide sufficient electrical stimulation to treat urinary incontinence. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Schuttler et al, with applying cathodic electrical as taught by Wei et al, since such a modification would provide the predictable results of sufficient electrical stimulation to treat urinary incontinence.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuttler et al (US Publication 2019/0060641).
Referring to Claim 20, Schuttler et al teaches the implantable neuromodulation device of claim 10, except wherein the non-linear channel comprises an “S” shape. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Schuttler et al with the non-linear channel comprises an “S” shape, because Applicant has not disclosed that non-linear channel comprises an “S” shape provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with shape of the non-linear channel as taught by Schuttler et al, because it provides retaining the nerve in the cuff and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Schuttler et al.
Therefore, it would have been an obvious matter of design choice to modify Schuttler et al to obtain the invention as specified in the claim(s).
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 1-19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6-9 and 12-17 of U.S. Patent No. 12,226,627. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Coates et al (US Publication 2024/0024668) discloses a nerve cuff with “L” and “S” shaped channels.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM 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, David 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.
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.
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights