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 § 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 1-4, 6-9, 11-20, 22-25 and 27 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Opie et al. (US 2018/0303595, hereinafter “Opie”).
In regards to claim 1, Opie discloses an endovascular medical device (pars. 0010-0012) comprising:
an elongated body configured to be introduced in a cranial blood vessel of a patient (pars. 0089, 0097); and
an expandable element on the elongated body (par. 0092, “elongated body” elements 62 and 224, “expandable element” element 108),
wherein the expandable element includes a plurality of loops, each respective loop of the plurality of loops having a respective connection point on the elongated body where the respective loop is connected to the elongated body (loops of element 108 containing electrodes 131; Figs. 51A and 51B; see annotated Fig. 51B below) wherein each loop includes one or more electrodes (elements 131; par. 0099, 0106), and
wherein the expandable element is configured to expand radially outwards from a relatively low-profile delivery configuration to a deployed configuration to position the one or more electrodes to deliver electrical stimulation to tissue of a brain of a patient or sense a patient parameter from a location within the cranial blood vessel (e.g., Figs. 25, 26, 51A and 51B; pars. 0195-0198).
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In regards to claim 2, each loop defines a flower petal shape, and wherein the plurality of loops is distributed around an outer perimeter of the elongated body (e.g., Fig. 51B; each of the loops containing an electrode are “flower petal shape” and are along an outer perimeter; Fig. 51A).
In regards to claim 3, at least two electrodes of at least one loop of the plurality of loops are independently activatable (par. 0271; “[t]he electrodes 131 can be independent from one another”).
In regards to claim 4, at least two electrodes of at least one loop of the plurality of loops are shorted together (par. 0115; “[t]he electrodes 131 can be one or more exposed sections on the insulated lead wire 141”; par. 0113, “there may be one or more electrodes 131 per wire strand 141”; any number of electrodes can be defined by the path taken on the lattice to define a “loop”).
In regards to claim 6, the expandable element includes a plurality of expandable elements, each expandable element including one or more electrodes (e.g., Figs. 51A and 51B; each of the loops containing an electrode being each of a plurality of expandable elements).
In regards to claim 7, each expandable element of the plurality of expandable elements includes a respective plurality of loops, wherein for each expandable element, each respective loop of the respective plurality of loops extends radially outward from a common longitudinal location along the elongated body, and wherein each expandable element of the plurality of expandable elements is longitudinally separated from adjacent expandable elements along a longitudinal axis of the elongated body (e.g., Fig. 51B; for the purposes of this claim, “each expandable element” is a “column” of loops of 108; note also that all elements extend radially outward from element 62).
In regards to claim 8, at least two electrodes of at least one expandable element of the plurality of expandable elements are independently activatable (par. 0271).
In regards to claim 9, at least two electrodes of at least one expandable element of the plurality of expandable elements are shorted together (par. 0115; “[t]he electrodes 131 can be one or more exposed sections on the insulated lead wire 141”; par. 0113, “there may be one or more electrodes 131 per wire strand 141”).
In regards to claim 11, the expandable element includes a shape memory material (pars. 0115, 0192, 0224).
In regards to claim 12, the expandable element includes an electrically conductive material radially inwards of an electrically insulative material, wherein the at least a portion of the electrically insulative material is removed to expose the electrically conductive material (par. 0115; “[t]he electrodes 131 can be one or more exposed sections on the insulated lead wire 141”).
In regards to claim 13, the exposed electrically conductive material defines at least one electrode of the one or more electrodes (par. 0115; “[t]he electrodes 131 can be one or more exposed sections on the insulated lead wire 141”).
In regards to claim 14, the device further comprises an electrode material connected to the expandable element and in electrical contact with the exposed electrically conductive material (Figs. 9 and 13a; pars. 0110, 0115, 0119).
In regards to claim 15, the electrode material includes one or more of a coil or a band (Fig. 9; par. 0110).
In regards to claim 16, the electrode material comprises at least one of platinum, tungsten, or gold (par. 0115).
In regards to claim 17, the device further comprises processing circuitry configured to selectively operate the one or more electrodes in a chronic mode or a trial mode, wherein to operate the one or more electrodes in the trial mode, the processing circuitry is configured to operate the one or more electrodes for a trial period to determine an efficacy of electrical stimulation or sensing (pars. 0090-0095, 0300, element 12; control unit operates the electrodes “in periods of higher-risk (including when the patient is unwell, or having to make modifications to their treatment regimen) the physician is able to assess neural signal in real time” and can also be operated in a chronic mode where the physician does not access the neural signals in real time).
In regards to claim 18, Opie discloses an endovascular medical device (pars. 0089, 0097) comprising:
an elongated body comprising an expandable element (par. 0092, “elongated body” elements 62 and 224, “expandable element” element 108), the expandable element comprising a plurality of loops, each respective loop of the plurality of loops having a respective connection point on the elongated body where the respective loop is connected to the elongated body (loops of element 108 containing electrodes; Figs. 51A and 51B; see annotated Fig. 51B above); and
one or more electrodes on the expandable element (elements 131; par. 0099, 0106),
wherein each loop of the plurality of loops extends radially outward from a common longitudinal location on the elongated body (e.g., loops 1 and 4 or loops 2 and 3), and
wherein the expandable element is configured to expand radially outwards from a relatively low-profile delivery configuration to a deployed configuration to position the one or more electrodes to deliver electrical stimulation to tissue of a brain of a patient or sense a patient parameter from a location within a cranial blood vessel of the patient (pars. 0195-0198, 0089, 0097).
In regards to claim 19, at least two electrodes of at least one expandable element of the plurality of expandable elements are independently activatable (par. 0271).
In regards to claim 20, at least two electrodes of at least one loop of the plurality of loops are shorted together (par. 0115; “[t]he electrodes 131 can be one or more exposed sections on the insulated lead wire 141”; par. 0113, “there may be one or more electrodes 131 per wire strand 141”; any number of electrodes can be defined by the path taken on the lattice to define a “loop”).
In regards to claim 22, the expandable element includes a plurality of expandable elements distributed along a longitudinal axis of the elongated body (Fig. 51B).
In regards to claim 23, Opie discloses an endovascular medical device (pars. 0089, 0097) comprising:
an elongated body comprising a plurality of expandable elements (par. 0092, “elongated body” elements 62 and 224, “expandable elements” 108), each expandable element comprising a loop, each respective loop of the plurality of loops having a respective connection point on the elongated body where the respective loop is connected to the elongated body (loops/cells of element 108 containing electrodes; e.g., Figs. 51A and 51B, see annotated Fig. 51B above); and
a plurality of electrodes,
wherein at least one electrode of the plurality of electrodes is positioned on a respective expandable element of the plurality of expandable elements (Figs. 51A and 51B),
wherein the plurality of expandable elements is longitudinally separated from each other along a longitudinal axis of the elongated body (see annotated Fig. 51B above; loops 1 and 4 are longitudinally separated from loops 2 and 3), and
wherein the expandable element is configured to expand radially outwards from a relatively low-profile delivery configuration to a deployed configuration to position the one or more electrodes to deliver electrical stimulation to tissue of a brain of a patient or sense a patient parameter from a location within a cranial blood vessel of the patient (e.g., pars. 0195-0198, 0089, 0097).
In regards to claim 24, at least two electrodes of the plurality of electrodes are positioned on an expandable element of the plurality of expandable elements, the at least two electrodes being independently activatable (par. 0271).
In regards to claim 25, at least two electrodes of the plurality of electrodes are positioned on an expandable element of the plurality of expandable elements, the at least two electrodes being shorted together (par. 0115; “[t]he electrodes 131 can be one or more exposed sections on the insulated lead wire 141”; par. 0113, “there may be one or more electrodes 131 per wire strand 141”; Figs. 29 and 30).
In regards to claim 27, each expandable element of the plurality of expandable elements includes a respective plurality of loops, wherein for each expandable element, each respective loop of the respective plurality of loops extends radially outward from a common longitudinal location along the elongated body (e.g., Fig. 51B; for the purposes of this claim, “each expandable element” is a “column” of loops of 108; note also that all elements extend radially outward from element 62; see also Figs. 29 and 30).
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 5, 10, 21 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Opie in view of Hoffer (US 2010/0036451, hereinafter “Hoffer”). Opie discloses the essential features of the claimed invention, including each loop/expandible element having a plurality of electrodes (because “loops” can be arbitrarily defined along the different struts of Opie’s lattice structure, and see interpretation of “expandable element” above), but does not expressly disclose that electrodes of the loops/expandable elements that face in the same direction are shorted together. However, Hoffer in the same field of endeavor of intravascular electrical stimulation teaches providing an expandable element having electrodes to a blood vessel wherein electrodes of the element that face in the same direction are shorted together (par. 0143, “a row of smaller electrodes that are electrically connected together”) to provide the predictable results of more effectively reaching the neural target based on the relative orientation of the target to the blood vessel orientation (par. 0143). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Opie by providing the expandable element wherein electrodes of the element that face in the same direction are shorted together to provide the predictable results of more effectively reaching the neural target based on the relative orientation of the target to the blood vessel orientation.
Response to Arguments
Applicant’s arguments with respect to claims 1-27 have been considered but are moot in part and not persuasive in part. The claims above are rejected in view of a different embodiment/interpretation of Opie, as set forth above. This rejection is based on the embodiment of, e.g., Fig. 51B wherein the “elongated body” includes reinforced section 62. Under this interpretation, loops of struts 108 each have a respective connection point on the elongated body (including element 62). The previous rejection under section 112 is withdrawn.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/ Primary Examiner, Art Unit 3792
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