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 Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1, 3-7, 9-10, 12-15, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rondoni et al. (Pub. No.: US 2020/0230412 A1); hereinafter referred to as “Rondoni”.
Regarding claim 1, Rondoni discloses a system (e.g. see figure 19A element 1100) for stimulating a nerve (e.g. see [0046]), comprising: an implantable pulse generator (e.g. see figure 19A element 1110) configured to generate a current; and an electrode device (e.g. see figure 19A element 1104, figure 1 element 100) in communication (e.g. see figure 19A element 1102) with the implantable pulse generator and configured to surround the nerve (e.g. see [0046], [0053]), the electrode device comprising: a housing (e.g. see figure 1 element 101, [0051]) comprising an inner surface, a first edge (e.g. see figure 1 element 135, [0051]), and a second edge (e.g. see figure 1 element 151, [0051]) opposite the first edge; at least one electrode (e.g. see figure 1 elements 103A, 103B, 103C, [0053]-[0054]) disposed on the inner surface and configured to apply the current to the nerve; and at least one closure (e.g. see figure 1 elements 134 and 150, [0051]) configured to further apply the current to the nerve (e.g. see figure 1 elements 113A, 113B, 113C, [0053]-[0054]. Note: The closure 134/150 is applying electrodes 113A, 113B, 113C to the nerve and thus is “configured to further apply the current to the nerve”) and to couple the first edge to the second edge to form a seal (e.g. see [0051], “re-closable lumen”).
Regarding claims 3 and 12, Rondoni discloses the housing is cylindrical (e.g. see figure (e.g. see figures 4, 5B, 6A).
Regarding claims 4 and 13, Rondoni discloses the at least one electrode extends around an inner perimeter of the housing from the first edge to the second edge such that the at least one electrode extends around an entirety of the inner perimeter when the seal is formed (e.g. see figure 8A, [0151], “circumferential orientation”. Note: In this orientation, the electrodes will extend around the perimeter as they are common to each other per [0151]).
Regarding claims 5 and 14, Rondoni discloses the at least one electrode comprises a plurality of electrodes each spaced apart along a center axis of the housing (e.g. see figure 1 elements 103A, 103B, 103C, 113A, 113B, 113C, [0053]-[0054]).
Regarding claims 6 and 15, Rondoni discloses the at least one closure comprises a plurality of closures, each closure positioned adjacent to a corresponding electrode (e.g. see figure 4 element 200. Note: The distal, middle, and proximal portions may be interpreted as different “closures”).
Regarding claim 7, Rondoni discloses each closure (e.g. see figure 1 elements 134 and 150, [0051]) comprises a first closure component (e.g. see figure 1 element 135, [0051]) and a second closure component (e.g. see figure 1 element 151, [0051]), the first closure component positioned on the first edge and the second closure component positioned on the second edge, wherein the first closure component and the second closure component are configured to lock together (e.g. see [0051], “re-closable lumen”).
Regarding claims 9 and 17, Randoni discloses the at least one closure comprises a first closure component (e.g. see figure 1 element 135, [0051]) and a second closure component (e.g. see figure 1 element 151, [0051]), and wherein the at least one electrode (e.g. see figure 1 elements 103A, 103B, 103C, 113A, 113B, 113C, [0053]-[0054]), the first closure component, and the second closure component are formed as a single component (e.g. see figure 1).
Regarding claim 10, see the rejection for claims 1 and 7 above.
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.
Claim(s) 2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni in view of Durand et al. (Pub. No. US 2008/0046055 A1); hereinafter referred to as “Durand”.
Regarding claims 2 and 11, Rondoni discloses the claimed invention but is silent as to the closure comprises at least one a snap closure or hook and loop fabric. Durand teaches that it is known to use such a modification as set forth in [0043]-[0044] to provide additional/alternative nerve cuff closure options. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use other closure types as taught by Durand in the system of Rondoni, since said modification would provide the predictable results of additional/alternative nerve cuff closure options.
Claim(s) 8 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni in view of Nieves (Pub. No. US 2019/0174891 A1).
Regarding claims 8 and 16, Rondoni discloses the claimed invention but is silent as to the at least one closure comprises a first kiss lock with a first end attached to the first edge and a second end opposite the first end, and a second kiss lock with a first end attached to the second edge and a second end opposite the first end, wherein the second end of the first kiss lock and the second end of the second kiss lock each comprise a shape that engage with one another to form the seal. Nieves teaches that it is known to use such a modification as set forth in figures 1-5 elements 14 and 15, [0014] to allow the user to easily and conveniently open and close the present invention (e.g. see [0014]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a kiss lock as taught by Nieves in the system of Rondoni, since said modification would provide the predictable results of allowing the user to easily and conveniently open and close the present invention.
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni in view of Baru et al. (Pub. No.: US 2015/0374296 A1); hereinafter referred to as “Baru”.
Regarding claim 18, Rondoni discloses a processor (e.g. see figure 20 element 1703, [0202]); and a memory (e.g. see figure 20 element 1704, [0202]) storing data for processing by the processor but is silent as to beginning a treatment by causing the at least one electrode to apply the current to the nerve when the first edge and the second edge form the seal; and receive a first impedance measurement associated with applying the current to the nerve when first edge and the second edge form the seal and a second impedance measurement associated with applying the current to the nerve when the first edge and the second edge are unsealed; and end the treatment when the first impedance measurement and the second impedance measurement are within an order of magnitude of one another. Baru teaches it is known to use such a modification as set forth in [0055] (“Sub-threshold pulses can also be delivered through the ring contacts 102 for impedance measurement to assess potential nerve 103 damage, connective tissue growth, or closing structure 104 failure) to provide an assessment of the closing structure status (e.g. see [0055]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use impedance measurement to assess closing structure as taught by Baru in the system of Rondoni, since said modification would provide the predictable results of an assessment of the closing structure status.
Regarding claim 20, Rondoni discloses each closure (e.g. see figure 1 elements 134 and 150, [0051]) comprises a first closure component (e.g. see figure 1 element 135, [0051]) and a second closure component (e.g. see figure 1 element 151, [0051]), the first closure component positioned on the first edge and the second closure component positioned on the second edge, wherein the first closure component and the second closure component are configured to lock together (e.g. see [0051], “re-closable lumen”).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni and Baru as applied to claim 18 above in view of Durand.
Regarding claim 19, Rondoni and Baru disclose the claimed invention but are silent as to the closure comprises at least one a snap closure or hook and loop fabric. Durand teaches that it is known to use such a modification as set forth in [0043]-[0044] to provide additional/alternative nerve cuff closure options. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use other closure types as taught by Durand in the system of Rondoni and Baru, since said modification would provide the predictable results of additional/alternative nerve cuff closure options.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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