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 amendment and arguments filed 12/02/2025, with respect to the rejection of the claims under 35 USC 102 and 103 relying on Vetter have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mercanzini et al. (2016/0287863).
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 1-6, 8, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mercanzini et al. (2016/0287863).
Regarding Claims 1, 6, 8 and 11, Mercanzini discloses an electrode array comprising a cylindrical insulating body 200 having an electrically insulating material and having a diameter that is at least 400 microns and a length greater than the diameter (Mercanzini discloses the dimensions can vary based on the desired anatomical target, see par. [0084], but that the elongated body 200 carrying the microelectrodes can have a length of 8mm and a diameter of 1.25mm, par. [0139]). Mercanzini further discloses a first plurality of microelectrodes disposed along the length and spaced apart in a range of 200-600 microns, each microelectrode being electrically independent from one another (Mercanzini discloses various embodiments of electrode arrays at the end of probe 200. The Example of Fig. 13B, D discloses a first plurality (row) of microelectrodes 249 each spaced apart and electrically independent from one another, i.e. they are individually addressable, see Claim 6 and par. [0111]. Mercanzini discloses that the spacing of electrode sin each embodiment is preferably 500 microns since such spacing is “particularly efficient in stimulating neural tissue”). Mercanzini additionally discloses a second plurality of microelectrodes disposed along the length opposite the first plurality, wherein each electrode of the second plurality is electrically independent of every other microelectrode of the second plurality (Again, in the embodiment of Fig. 13B, D, Mercanzini discloses a second row of electrodes 249 spaced on the opposite side of probe 200, again each being individually addressable thus making them electrically independent from thew other electrodes). Lastly, Mercanzini discloses the electrically insulating material is radially positioned between the first and second microelectrode (the electrodes are formed on a substrate that is made of an insulative material. Fig. 13B , D show the substrate radially positioned between and around each electrode 249 of the respective arrays, e.g. the dark gray portions in the figures, see par. [0088, 0130]). The Examiner notes the languages “configured such that the insulating body provides directional isolation…” is an intended use recitation that fails to further limit the structure of the claims. The Examiner is interpreting the radial positioning of the insulating material as providing this function. If there is some other configuration that provides this function, the Examiner suggests amending the claim to include such structure.
In regard to Claim 2, Mercanzini discloses an embodiment in Fig. 13 B, D that has four rows of electrodes, each spaced around the diameter of probe 200, wherein each adjacent row is approximately orthogonal to one another. In Fig. 13B, when wrapped around the probe, the two visible rows are the claimed first and third pluralities, with the second plurality not visible on the back of the probe. When unwrapped, Fig. 13D shows the rows where the top row would be the first plurality, the second row would be the third plurality and the third row would be the second plurality of microelectrodes. Alternatively, Fig. 15A-H show other examples of electrode configurations and their relative orientations to one another in 90 degree increments.
With regard to Claim 3, Mercanzini discloses in the same embodiment of Fig. 13 B, D a fourth row not visible in Fig. 13B but shown as the fourth row in Fig. 13D that is opposite the third row of microelectrodes.
Regarding Claims 4 and 5, Mercanzini discloses fifth, sixth, seventh and eighth rows of electrodes 248 spaced between the first through fourth rows of electrodes, each row being orthogonal to the adjacent row, much like tht of the first through fourth plurality of electrodes (Fig. 13 B, D).
In regard to Claim 9, Mercanzini discloses that generally, a microelectrode diameter of 500 microns is preferred (par. [0079]) but could be as small as 150 micorns in the example of Fig. 13B.
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 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mercanzini et al. (2016/0287863).
Regarding Claim 7, Mercanzini discloses the dimensions can vary based on the desired anatomical target (see par. [0084]); that a typical diameter for such devices has been around 600 microns (par. [0007); and that other embodiments envisioned could have diameters as large as 1.27mm (par. [0091]) but does not disclose the exact diameter of 800 microns for the insulating body. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to limit the diameter to approximately 800 microns, 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.
Furthermore, it would have been an obvious matter of design choice to limit the diameter to approximately 800 microns, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding Claim 12, Mercanzini discloses the size and shape of the probe can be adjusted based on its intended neurological application (par. [0084]) but does not disclose an insulating body having a polygonal cross-section. It would have been an obvious matter of design choice to make the cross-section of the insulating body of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mercanzini et al. (2016/0287863) in view of Boling (6,597,953). Mercanzini discloses the dimensions can vary based on the desired anatomical target (see par. [0084]); that a typical diameter for such devices has been around 600 microns (par. [0007); and that other embodiments envisioned could have diameters as large as 1.27mm (par. [0091]) but does not disclose the exact diameter of 800 microns for the insulating body. However, Boling, in the same field of endeavor of deep brain stimulation leads, discloses lead diameters ranging from 0.5mm to 1.5mm for the purpose of promoting ease of handling (col. 5, lines 42-50) such as by making the leads easier to position shallow or relatively deep in the brain (col. 4, lines 39-42). 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 Mercanzini reference to include making the lead diameter anywhere in the range of 0.5mm to 1.5mm, as taught and suggested by Boling, for the purpose of making the leads easier to position shallow or relatively deep in the brain. Regarding the value of approximately 800 microns, it would have been obvious to one having ordinary skill in the art at the time the invention was made to limit the modified lead of Mercanzini and Boling to approximately 800 microns, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mercanzini et al. (2016/0287863) in view of McCreery et al. (8,831,739). Mercanzini discloses the size and shape of the probe can be adjusted based on its intended neurological application (par. [0084]) but does not disclose an insulating body having a polygonal cross-section. However, in the same field of endeavor of implantable brain leads, McCreery discloses incorporating a reinforced polygonal shaped cross-section (see Fig. 7) for the lead for the purpose of adding greater resistance to bending as needed during tissue insertion (col. 3, lines 65-66). 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 Mercanzini reference to include a polygonal cross-section, as taught and suggested by McCreery, for the purpose of adding greater resistance to bending as needed during tissue insertion.
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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/ALLEN PORTER/Primary Examiner, Art Unit 3796