DETAILED ACTION
This action is pursuant to the claims filed on 09/10/2024. Claims 1-12 are pending. A first action on the merits of claims 1-12 is as follows.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3 and 12 are objected to because of the following informalities:
Claim 3 should read “are configured to be in contact with the upper and lower parts of the nerve, respectively” to maximize clarity and avoid reciting a human organism.
Claim 12 should be dependent from claim 7 as it recites antecedent basis to the method claim yet erroneously refers to the apparatus of claim 1. This error is understood as a simple typo by the Examiner.
Appropriate correction is required.
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.
Claims 7-12 are 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 7 recites the limitation "second coating the shape memory polymer". It is unclear if “second coating” is to be interpreted a second coating of the shape memory polymer such that there are two distinct SMP layers or if the SMP has a “second coating”. For examination purposes, this limitation will be interpreted as a second coating of the SMP on top of the electrode material with the second SMP being etched. Claims 8-12 inherit this deficiency.
Claim 11 recites the limitation “the adhesion material”. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (Lee, Sanghoon, et. al., “Toward Bioelectronic Medicine—Neuromodulation of Small Peripheral Nerves Using Flexible Neural Clip”, Advanced Science, 2017).
Regarding claim 1, Lee teaches A neural interface, comprising: an electrode section for neural stimulation and neural signal recording (Fig 2 active electrodes); a first region defined by a first hole (Fig 2c, first region interpreted by entire distal end of interface at least partly defined by circular holes); and a second region defined by a second hole disposed within the first region (Fig 2c, second region interpreted as region defined by clip-cavity with two active electrodes therein; second region being confined within the first region), wherein the electrode section comprises a first electrode section and a second electrode section (Fig 2c peripheral of neural interface interpreted as first electrode section; clip cavity region at the “second region” as claimed is interpreted as the second electrode section), either the first electrode section or the second electrode section being disposed within the second region (Fig 2c, the second electrode section is disposed within the second region).
Regarding claim 2, Lee further teaches wherein, the first electrode section is disposed at an edge of the neural interface (Fig 2c, electrodes at top or bottom of 2c is interpreted as first electrode at an edge of the neural interface), and the second electrode section is disposed within the second region (Fig 2c, active electrode within clip-cavity and clip-strip region is interpreted as second electrode within second region).
Regarding claim 3, Lee further teaches wherein the first electrode section and the second electrode section are in contact with the upper and lower parts of the nerve, respectively (Fig 2biii and 2c, first electrode section with peripheral electrodes are in contact with the upper part of the nerve; the second electrode section (i.e., clip-strip) is in contact with lower part of the nerve).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Ma (U.S. PGPub No. 2016/0007874).
Regarding claim 4, in view of the combination of claim 1 above. Lee further teaches wherein the electrode section comprises a substrate (Pg 8 section 5; polyimide layer is base substrate layer of device); and a conductive layer disposed on the adhesion layer (Pg 8, Section 5; “A layer of 20 nm chrome (Cr) was deposited to improve the adhesion of the next conduction layer by sputtering. After a 250 nm gold layer was deposited, the conductive metal layer was patterned by a lift-off process in acetone”; gold layer defines conductive contacts of electrodes with adhesion Cr layer underneath).
Lee fails to teach wherein the electrode section comprises: a shape memory polymer (SMP) layer disposed between the substrate and adhesion layer.
In related prior art, Ma teaches a similar neural interface device comprising a shape memory polymer base layer and overlayer ([0035] and Fig 1). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lee in view of Ma to incorporate a shape memory polymer layer between the substrate and adhesion layer to arrive at claim 4. Doing so would advantageously enable the device to undergo a planar to non-planar transformation in response to a change in temperature to enable the device to be flexible when implanted ([0035]).
Regarding claim 5, in view of the combination of claim 1 above. Lee further teaches wiring electrically connected to the electrode section (see wiring of Fig 2), wherein the wiring comprises: a substrate (Pg 8 section 5; polyimide layer is base substrate layer of device); an adhesion layer; a conductive layer disposed on the adhesion layer (Pg 8, Section 5; “A layer of 20 nm chrome (Cr) was deposited to improve the adhesion of the next conduction layer by sputtering. After a 250 nm gold layer was deposited, the conductive metal layer was patterned by a lift-off process in acetone”; gold layer defines conductive pads of wiring with adhesion Cr layer underneath); and a second layer disposed on the conductive layer (Pg 8 Section 5; second polyimide layer is disposed onto the conductive layer).
Lee fails to teach a first SMP layer disposed on the substrate and under the adhesion layer; and wherein the second layer disposed on the conductive layer is a second SMP layer.
In related prior art, Ma teaches a similar neural interface device comprising a shape memory polymer base layer and overlayer ([0035] and Fig 1). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lee in view of Ma to incorporate a shape memory polymer layer between the substrate and adhesion layer and a second SMP overlayer disposed over the conductive layer to arrive at claim 5. Doing so would advantageously enable the device to undergo a planar to non-planar transformation in response to a change in temperature to enable the device to be flexible when implanted ([0035]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Ma, and in further view of Modi (U.S. PGPub No. 2018/0124926).
Regarding claim 6, in view of the combinations of claims 4 or 5 above.
Lee/Ma fail to teach wherein the shape memory polymer is synthesized by polymerizing 1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (TATATO), trimethylolpropanetris(3-mercaptopropionate) (TMTMP), and tricyclodecanedimethanoldiacrylate (TCMDA).
In related prior art, Modi teaches a similar device comprising a similar shape memory polymer synthesized by polymerizing1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (TATATO), trimethylolpropanetris(3-mercaptopropionate) (TMTMP), and tricyclodecanedimethanoldiacrylate (TCMDA) ([0037] shape memory polymer formed from TATATO, TMTMP, and TCMDA). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee in view of Ma and Modi to incorporate the SMP synthesized as claimed to arrive at the device of claim 6. Doing so would advantageously enable the device to undergo a planar to non-planar transformation in response to a change in temperature to enable the device to be flexible when implanted ([0035]). Furthermore, providing the SMP formed from TATATO, TMTMP, and TCMDA would be obvious to one of ordinary skill in the art as the use of these materials to form a SMP is well-known in the art to yield predictable results therein.
Claim(s) 7, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Ma, and in further view of Santini (U.S. PGPub No. 2003/0049865).
Regarding claim 7, Lee teaches A method for fabricating a neural interface, the method comprising the steps of: forming a photoresist on the shape memory polymer; masking the photoresist; sputtering an electrode material (electrode material is deposited); patterning the electrode material through a photolithography process (Pg 8 section 5, conductive metal layer is patterned by acetone lift-off process); second coating (Pg 8 section 5; second polyimide layer disposed over conductive metal layer); and patterning the second polyimide layer (Pg 8 section 5; second polyimide layer is patterned to expose the sensing contacts and connection pads).
Lee fails to teach synthesizing a shape memory polymer; first coating a substrate with the shape memory polymer; the electrode material being sputtered; the second coating being the shape memory polymer; and etching the shape memory polymer instead of patterning.
In related prior art, Ma teaches synthesizing a shape memory polymer ([0035] and Fig 1); the second coating being the shape memory polymer ([0035] SMP overlayer 108). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and second polyimide layer of Lee in view of Ma to incorporate a first shape memory polymer layer on the substrate and a second SMP overlayer in place of the second polyimide layer. Providing the first SMP layer would advantageously enable the device to undergo a planar to non-planar transformation in response to a change in temperature to enable the device to be flexible when implanted ([0035]). Furthermore, substituting the second polyimide layer of Lee in view of the second SMP overlayer of Ma would similarly advantageously enable the device to undergo a planar to non-planar transformation in response to a change in temperature to enable the device to be flexible when implanted ([0035]).
Lee/Ma fail to explicitly teach the electrode material being sputtered and etching the shape memory polymer instead of patterning.
In related prior art, Santini teaches a similar method wherein a material can be deposited by one of many methods “such as chemical vapor deposition (CVD), electron or ion beam evaporation, sputtering, or spin coating” ([0071]) and a “dielectric material can be etched by plasma, ion beam, or chemical etching techniques” ([0071]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the electrode material and second polyimide material of Lee in view of Ma and Santini to incorporate the step of sputtering the electrode material and etching the dielectric material as a second SMP to arrive at claim 7. Doing so would be obvious to one of ordinary skill in the art as the use of a sputtering technique for depositing material is well-known in the art as a simple selection of one of many known depositing techniques to yield the predictable result of providing a material to a surface of a microfabricated device ([0071]). Furthermore, the use of an etching technique is similarly well-known in the art as a simple selection of one of many known depositing techniques to yield the predictable result of providing a material to a surface of a microfabricated device ([0071]).
Regarding claim 9, in view of the combination of claim 7 above, Lee further teaches a step of spin-coating various materials (Pg 8 section 5, various materials are spin-coated on to the device; including the polyimide substrate, the layer of AZ 9260, and the second polyimide overlayer). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Lee in view of Ma and Santini to incorporate the SMP via spin-coating. Providing the SMP via spin-coating would be obvious to one of ordinary skill in the art as the technique of spin-coating would simply require choosing from one of a finite number of identified, predictable deposition techniques for yield the predictable result of providing a material to a surface of a microfabricated device (Pg 8 section 5 of Lee disclosing well-known use of spin-coating technique).
Regarding claim 11, in view of the combination of claim 7 above, Lee further teaches wherein in the sputtering step, the adhesion material and the conductive material are formed by sputtering (Pg 8 section 5; “A layer of 20 nm chrome (Cr) was deposited to improve the adhesion of the next conduction layer by sputtering”). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Lee in view of Ma and Santini to incorporate the conductive material via sputtering. Providing the conductive material via sputtering would be obvious to one of ordinary skill in the art as the technique of sputtering would simply require choosing from one of a finite number of identified, predictable deposition techniques for yield the predictable result of providing a material to a surface of a microfabricated device (Pg 8 section 5 of Lee disclosing well-known use of sputtering technique).
Claim(s) 8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Ma, Santini, and in further view of Modi.
Regarding claim 8, in view of the combinations of claim 7 above.
Lee/Ma/Santini fail to teach wherein the step of synthesizing a shape memory polymer is carried out by polymerizing 1,3,5-triallyl-1,3,5-triazine- 2,4,6(1H,3H,5H)-trione (TATATO), trimethylolpropanetris(3-mercaptopropionate) (TMTMP), and tricyclodecanedimethanoldiacrylate (TCMDA).
In related prior art, Modi teaches a similar device comprising a similar shape memory polymer synthesized by polymerizing1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (TATATO), trimethylolpropanetris(3-mercaptopropionate) (TMTMP), and tricyclodecanedimethanoldiacrylate (TCMDA) ([0037] shape memory polymer formed from TATATO, TMTMP, and TCMDA). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee in view of Ma, Santini, and Modi to incorporate the SMP synthesized as claimed to arrive at the method of claim 8. Doing so would advantageously enable the device to undergo a planar to non-planar transformation in response to a change in temperature to enable the device to be flexible when implanted ([0035]). Furthermore, providing the SMP formed from TATATO, TMTMP, and TCMDA would be obvious to one of ordinary skill in the art as the use of these materials to form a SMP is well-known in the art to yield predictable results therein.
Regarding claim 12, in view of the combination of claim 7 above, Lee/Ma/Santini fail to teach wherein the etching step comprises reactive ion etching using oxygen plasma.
In related prior art, Modi teaches wherein the etching step comprises reactive ion etching using oxygen plasma ([0011] [0075]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Lee in view of Ma, Santini, and Modi to incorporate the step of reactive ion etching using oxygen plasma to arrive at claim 12. Doing so would be obvious to one of ordinary skill in the art as the use of reactive ion etching with oxygen plasma is well-known in the art as a form of etching to yield predictable results therein ([0011] [0075]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Ma, Santini, and in further view of Peng (U.S. PGPub No. 2002/0136963).
Regarding claim 10, in view of the combination of claim 7 above, the Lee/Ma/Santini references fail to teach wherein in the masking step, the photoresist is patterned using a chrome hard mask and a mask aligner.
In related prior art, Peng teaches a similar method wherein in the masking step, the photoresist is patterned using a chrome hard mask and a mask aligner ([0031] chrome hard mask layer with self-aligned shifting material in etch process). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Lee in view of Ma, Santini, and Peng to incorporate the patterning of the photoresist via a chrome hard mask and mask aligner to arrive at the method of claim 10. Providing the masking step via patterning using a chrome hard mask and mask aligner would be obvious to one of ordinary skill in the art as the technique of using a chrome hard mask and mask aligner in a masking step would simply require choosing from one of a finite number of identified, predictable deposition techniques for yield the predictable result of providing a material to a surface of a microfabricated device ([0031] of Peng disclosing well-known use of chrome hard mask and mask aligner).
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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