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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation "the first insulation layer". There is insufficient antecedent basis for this limitation in the claim since the claims on which is depends do not mention a first insulation layer. Examiner assumes it is meant to say “the first additional insulation layer” and treats it as so, correction is required.
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)(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 1-2 & 4-12 are rejected under 35 U.S.C 102(a)(2) as being anticipated by Shah et al. (US 20220175320) herein referred to as Shah.
Regarding claim 1, Shah discloses A neural probe (Figure 1) comprising a plurality of electrode parts to be inserted into a human body (Figure 1, 165); wherein the plurality of electrode parts each comprise a flexible substrate (Paragraph [0054]; wherein electrodes parts are disposed on a flexible substrate; Figure 6E, 610), electrodes disposed on one surface of the flexible substrate (Figure 6E, 625), and an insulation layer covering the one surface of the flexible substrate (Figure 6E, 605; Paragraph [0086]; wherein first polymer layer 605 may be comprised of dielectric material (i.e., an insulator)); and wherein the plurality of electrode parts are stacked (Figure 6E).
Regarding claim 2, Shah discloses the neural probe of claim 1, wherein a spacer layer is disposed on a side opposite to an end to be inserted into the human body between the plurality of electrode parts (Figure 6E, 620).
Regarding claim 4, Shah discloses the neural probe of claim 1, wherein the insulation layer comprises a first insulation layer (Figure 6E, 620), and a second insulation layer having higher flexibility than the first insulation layer (Figure 6E, 605; Paragraph [0091] & [0085]; wherein second insulation layer 605 can consist of silicon and the first insulation layer 620 can consist of glass wherein silicon has a higher flexibility than glass).
Regarding claim 5, Shah discloses the neural probe of claim 4, wherein part of the insulation layer covering the flexible substrate is the second insulation layer (Figure 6E, 605)
Regarding claim 6, Shah discloses the neural probe of claim 5, further comprising a connection part connected to the electrode parts (Figure 6E, 635) and provided with a terminal that is electrically connected to electrodes (Figure 6E, 630); wherein an insulation layer covering the connection part and an insulation layer covering a portion of the electrode part connected to the connection part are the first insulation layer (Figure 6E, 620).
Regarding claim 7, Shah discloses the neural probe of claim 6, wherein a drive circuit connected to the electrodes is mounted at a location corresponding to the first insulation layer (Figure 6E, 615; Paragraph [0064]; wherein the electronics module is able to apply a signal or electrical current to conductive traces of the lead assembly in which are connected to the electrodes)
Regarding claim 8, Shah discloses the neural probe of claim 7, further comprising a wiring connecting the electrodes and the drive circuit and formed on the substrate (Figure 6E, 615; Paragraph [0064]; wherein the electronics module is able to apply a signal or electrical current to conductive traces of the lead assembly in which are connected to the electrodes); wherein the wiring connects at least some of the electrodes in parallel to the drive circuit (Figure 6E, 615; Paragraph [0064]; wherein the electronics module is able to apply a signal or electrical current to conductive traces of the lead assembly in which are connected to the electrodes)
Regarding claim 9, Shah discloses the neural probe of claim 1, wherein the electrode part and the connection part comprise an additional insulation layer covering the substrate on an opposite surface of the substrate (Figure 6E, 620)
Regarding claim 10, Shah discloses the neural probe of claim 9, wherein the additional insulation layer comprises a first additional insulation layer (Figure 6E, 620, Paragraph [0057]; wherein insulative layer can comprises of one or more layers), and a second additional insulation layer having higher flexibility than the first additional insulation layer (Paragraph [0057]; wherein insulative layer can comprises of one or more layers; Paragraph [0091] & [0085]; wherein second insulation layer can consist of silicon and the first insulation layer can consist of glass wherein silicon has a higher flexibility than glass).
Regarding claim 11, Shah discloses the neural probe of claim 10, wherein an additional insulation layer covering the connection part and an additional insulation layer covering a portion of the electrode part connected to the connection part are the first additional insulation layer (Figure 6E, 620).
Regarding claim 12, Shah discloses the neural probe of claim 11, wherein a drive circuit connected to the electrodes is mounted at a location corresponding to the first insulation layer (Figure 6E, 615; Paragraph [0064]; wherein the electronics module is able to apply a signal or electrical current to conductive traces of the lead assembly in which are connected to the electrodes).
Claims 18-21 is rejected under 35 U.S.C 102(a)(1) as being anticipated by Masmanidis et al. (US 20130167360) herein referred to as Masmanidis.
Regarding claim 18, Masmanidis discloses A neural probe (Figure 3) comprising an electrode part to be inserted into a human body (Figure 4), wherein: the electrode part comprises: a flexible substrate (Figure 4, 101); electrodes disposed on one surface of the flexible substrate (Figure 4, 202A & 202B); and an insulation layer covering the flexible substrate on the one surface (Figure 4, 204A); and the electrodes comprise a first electrode disposed on one surface of the substrate and a second electrode disposed on an opposite surface thereof (Figure 4, 202A & 202B).
Regarding claim 19, Masmanidis discloses the neural probe of claim 18, wherein the first electrode disposed on the one surface of the substrate and the second electrode disposed on the opposite surface thereof are disposed at locations corresponding to each other (Figure 4, 202A & 202B; wherein they are directly placed directly on top of each other).
Regarding claim 20, Masmanidis discloses the neural probe of claim 19, further comprising a via or through hole formed through the substrate to connect the first and second electrodes (Figure 4, 401).
Regarding claim 21, Masmanidis discloses the neural probe of claims 18 , further comprising a protective film covering at least one surface of the electrode part (Figure 4, 204B).
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 3 is rejected under 35 U.S.C 103 as being unpatentable over Shah in view of Chamanzar et al. (US 20220043028) herein referred to as Chamanzar.
Regarding Claim 3, Shah discloses the neural probe of claim 1 wherein a spacer layer is disposed between the plurality of electrode parts (Figure 6E, 620), at least the spacer layer comprises a first spacer portion made of bio-insoluble adhesive (See annotated Figure 6E below; Paragraph [0091]; wherein 620 can be made of epoxy mixtures) a second spacer portion (See annotated Figure 6E below) and the first and second spacer portions are disposed in the spacer layer with the second spacer portion disposed on an end side to be inserted into the human body (Figure 6E; wherein second spacer potion is on the side with the electrodes in which are inserted into the body). However, Shah does not explicitly disclose a second spacer portion made of a bio-soluble adhesive.
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Chamanzar discloses a neural probe (Figure 1) comprising a spacer portion made of bio-soluble adhesive (Paragraph [0017]; wherein polymer layer is made of PEG which is a bioresorbable adhesive; Paragraph [0025]; wherein PEG covers the entire electrode structure therefore acts as a spacer layer in between the electrodes). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the second spacer layer taught by Shah to be bio soluble adhesive. The motivation being to be able to retracted the probe post-implantation after the PEG dissolves inside the brain, releasing the flexible probe (Chamanzar, Paragraph [0017]).
Claims 15-17 are rejected under 35 U.S.C 103 as being unpatentable over Shah in view of Masmanidis.
Regarding Claim 15, Shah discloses the neural probe of claim 1, wherein the electrodes comprise a first electrode and a second electrode (Figure 6E, 625). However, Shah does not explicitly disclose the second electrode disposed on an opposite surface thereof.
Masmanidis discloses a neural probe (Figure 3) the second electrode disposed on an opposite surface of the first electrode (Figure 4, 202A & 202B). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the locations of the electrodes taught by Shah to be on opposite surfaces of the substrate as taught by Masmanidis. The motivation being to provide electrical localization of neuronal signals (for better isolation of multiple units) and mechanical robustness of the shafts (more fault-tolerant due to the absence of through-holes, which may weaken the structure) (Masmanidis, Paragraph [0040]).
Regarding claim 16, Shah in view of Masmanidis disclose the neural probe of claim 15. Masmanidis also discloses wherein the first electrode disposed on the one surface of the substrate and the second electrode disposed on the opposite surface thereof are disposed at locations corresponding to each other (Figure 4, 202A & 202B; wherein they are directly placed directly on top of each other). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the locations of the electrodes taught by Shah to be on opposite surfaces of the substrate as taught by Masmanidis. The motivation being strong signal attenuation between the front and back side (Masmanidis, Paragraph [0070])
Regarding claim 17, Shah in view of Masmanidis disclose the neural probe of claim 16. Masmanidis also discloses further comprising a via or through hole formed through the substrate to connect the first and second electrodes (Figure 4, 401). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate taught by Shah to include through holes as taught by Masmanidis. The motivation being it is important for achieving precise back side feature alignment (Masmanidis, Paragraph [0013]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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