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 Preliminary Amendment
This Office Action is responsive to the preliminary amendment filed on 19 July 2024. As directed by the amendment: Claim 10 has been amended, no claims have been cancelled, and Claims 11-18 have been added. Thus, Claims 1-18 are presently pending in this application.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites “wherein at least two microelectrodes of the at least one microelectrode have different length”. This appears to be a typographical error, and should be amended to “wherein at least two microelectrodes of the at least one microelectrode have different lengths”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 5 and 6 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claim 5, the claim recites, “wherein the at least one microelectrode is implanted into an optic nerve”. These limitations are directed to an optic nerve, which encompasses a human organism, since no actual structure of the microelectrode/neural interface system is claimed (i.e., only a location/implantation is recited). Therefore, Claim 5 is ineligible under 35 U.S.C. 101. It is recommended by the Examiner that this limitation be amended to “wherein the at least one microelectrode is configured to be implanted into an optic nerve”. Claim 6 is rejected for depending on Claim 5.
Regarding Claim 6, the claim recites, “the at least one microprobe is fixed within an eye socket”. These limitations are directed to an eye socket, which encompasses a human organism, since no actual structure of the microelectrode/neural interface system is claimed (i.e., only a location/implantation is recited). Therefore, Claim 6 is ineligible under 35 U.S.C. 101. It is recommended by the Examiner that this limitation be amended to “the at least one microprobe is configured to be fixed within an eye socket”.
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.
Claims 1-3 and 5-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gefen et al. (US Publication No. 2011/0172736).
Regarding Claim 1, Gefen et al. discloses a neural interface system (Abstract, Paragraph 0002-0003, 0021, 0193-0196; see system 20, Fig. 1), comprising:
at least one microprobe (sections of apparatus 60 including electrode sections 90, Figs. 1-6; Paragraph 0196, 0198, 0209; including multiple implanted devices, Paragraph 0236),
wherein the at least one microprobe comprises a liner (substrate/attachment elements 62, 1020, 1030, 80, Figs. 4A-B, 5; Paragraph 0223-0225) and at least one microelectrode (electrodes 64 of array 90, Figs. 1-2A/B; electrodes 61, 1064, Figs. 4-5; Paragraph 0209, 0212, 0222-0224);
the liner is of an arc-shaped structure (substrate/attachment elements are curved, “For some applications, apparatus 60, including substrate 62, is flexible and can be adjusted to match the natural curvature of the retina during implantation. Apparatus 60 may be adjusted to match the retina of a subject by standard fitting and/or can be tailor made according to OCT imaging of the retina. Once adjusted to match the natural curvature of the retina, apparatus 60 is typically glued and/or stitched in place.” Paragraph 0235, 0059-0060; “the tips of the electrodes together define a convex curved surface having a radius of curvature that is 6-15 mm”, Paragraph 0061);
and the at least one microelectrode (electrodes 64 of array 90, Figs. 1-2A/B; electrodes 61, 1064, Figs. 4-5; Paragraph 0209, 0212, 0222-0224) is located on an outer side of the liner (substrate/attachment elements 62, 1020, 1030, 80, Figs. 1, 4A-B, 5; Paragraph 0212, 0223-0225).
Regarding Claim 2, Gefen et al. discloses a neural interface system further comprising an in vitro device (CMOS chip 1040, silicon wafer 1030, internal layer 1060, which communicates with external devices, Figs. 1, 4-5; Paragraph 0198, 0223-0226), wherein the in vitro device comprises an acquisition unit and a processing unit (acquisition and processing functions/elements including photosensing elements and driving circuitry which communicates with external devices, Paragraph 0020-0021, 0198-0199, 0212, 0224, 0226).
Regarding Claim 3, Gefen et al. discloses a neural interface system further wherein the acquisition unit is configured to acquire an image and the processing unit is configured to convert the image into a stimulus signal for reproducing a vision (“The driving circuitry drives electrodes 64 to apply currents to the retina, in response to sensing by the photosensor layer, in order to stimulate the retina 6. Accordingly, system 20 for restoring vision in a subject does not comprise an extraocular camera, and apparatus 60 does not receive image data from outside the eye, but rather utilizes the intact optics and processing mechanisms of the eye 4”, Paragraph 0199; “Layer 1060 typically comprises additional elements of an intraocular retinal prosthesis, e.g., an energy receiving layer, a photosensor layer and driving circuitry that is powered by the energy receiving layer. The driving circuitry typically drives current into the retinal tissue from the rough tips 1070 of electrodes 1064, in response to sensing by the photosensor layer, in order to stimulate the retinal tissue.”, Paragraph 0224; “The driving circuitry is powered by the energy receiving layer, which typically receives energy from an external device comprising an external power source 24 (e.g., a laser coupled to the frame of a pair of eyeglasses 25, and/or an RF energy source, and/or a magnetic energy source). For some applications a partially-transparent (e.g., half-silvered) mirror 23 is coupled to eyeglasses 25, providing ophthalmoscope functionality to the external device.”, Paragraph 0198).
Regarding Claim 5, Gefen et al. discloses a neural interface system further wherein the at least one microelectrode is implanted into an optic nerve (Paragraph 0003, 0021, 0195, 0205).
Regarding Claim 6, Gefen et al. discloses a neural interface system further comprising a fixation member (attachment of penetrating electrodes into eye structures, including glue/stitching, Paragraph 0218, 0226, 0232-0233, 0234-0235), and the at least one microprobe is fixed within an eye socket (see eye 4, Fig. 1; Paragraph 0218, 0226, 0232-0233, 0235) by the fixation member.
Regarding Claims 7-9, Gefen et al. discloses a neural interface system further wherein at least two microelectrodes of the at least one microelectrode have different lengths (electrodes 1064, 61, 62 vary in length, see Figs. 4A-B, 5, 6, 7; see Fig. 6 in part reproduced below; Paragraph 0073, 0076-0077, 0222, 0231-0232), wherein a length of a microelectrode located in a middle region is greater than a length of a microelectrode located in two edge regions (electrodes 1064, 61, 62 vary in length, with some middle electrodes longer than some edge electrodes, see Fig. 6 in part reproduced below, see also Fig. 7; Paragraph 0230-0233) or wherein a length of a microelectrode located in a middle region is smaller than a length of a microelectrode located in two edge regions (electrodes 1064, 61, 62 vary in length, with some middle electrodes shorter than some edge electrodes, see Fig. 6 in part reproduced below, see also Fig. 7; Paragraph 0230-0233).
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Regarding Claims 10-18, Gefen et al. discloses a neural interface system further wherein multiple microprobes (sections of apparatus 60 including electrode sections 90, Figs. 1-6; Paragraph 0196, 0198, 0209; including multiple implanted devices, Paragraph 0236) are provided, and a microprobe array formed by the multiple microprobes is in a shape of cambered surface (see curved/cambered surface of Figs. 4B, 6, 7; “electrodes 1064 typically vary in length, and as indicated by FIGS. 4A-B and 5, for some applications, tips 1070 of electrodes 1064 together define a convex curved surface having a radius of curvature that is 6-15 mm”, Paragraph 0229; “electrodes of varying heights and, optionally, shapes enable proper attachment of the apparatus to the curved structure of the retina”, Paragraph 0235).
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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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gefen et al. (US Publication No. 2011/0172736) in view of Rizzo et al. (US Publication No. 2003/0158588).
Regarding Claim 4, Gefen et al. discloses a neural interface system further wherein the in vitro device and microprobe further comprises wireless and RF elements to send/receive signals to between implanted elements and external devices (Paragraph 0198, 0236).
However, Gefen et al. does not explicitly disclose first and second wireless coils configured to send and receive wireless signals. Rizzo et al. teaches a neural interface system (Paragraph 0005-0007, 0027, 0035) comprising an in vitro device comprising a first wireless coil (primary coil 34 in external device 38, Figs. 2A-2B; Paragraph 0028-0030, 0037, 0047-0050), and at least one microprobe comprising electrodes (26, 28, 56, 58, Figs. 2, 3, 5) and a second wireless coil (secondary coil 32, Figs. 2A-2B; Paragraph 0028-0030, 0037, 0047-0050), and the first wireless coil is configured to send a stimulus signal and the second wireless coil is configured to receive a stimulus signal (sending/receiving data and energy, Paragraph 0019, 0028-0029, 0037, 0047-0050).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include first and second wireless coils configured to send and receive wireless signals, as taught by Rizzo et al., in the neural interface system disclosed by Gefen et al., in order to allow for the circuitry elements to be small, thereby minimizing the anatomical disruption of the delicate interior of the eye while maximizing the safe delivery of the energy/data needed to drive a large number of stimulating elements, as also taught by Rizzo et al. (Paragraph 0017, 0019, 0033).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796