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 arguments with respect to claim(s) 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Terminal Disclaimer
The terminal disclaimer filed on 02/04/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 17778234 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claims 22, 24, and 27 objected to because of the following informalities:
Regarding claim 22, the limitation of “…needs to be 50% or more” renders the claim unclear. Specifically, it is unclear if this is a preference or if the claim requires a stretchability of 50% or more. For examination purposes the claim is interpreted as requiring a stretchability of 50% or more. Examiner suggests amending the claim to recite “…has a stretchability of the element [[that needs to be]] of 50% or more”.
Regarding claim 24, the limitation of “…needs to be 100 degrees or more” renders the claim unclear. Specifically, it is unclear if this is a preference or if the claim requires an angle of the arc to be 100 degrees or more. For examination purposes the claim is interpreted as requiring the angle of the arc to be 100 degrees or more. Examiner suggests amending the claim to recite “…formed in an angle of the arc that is [[needs to be]] 100 degrees or more”.
Regarding claim 27, the limitation of “…at least one of a flexible material and structure” renders the claim unclear. Specifically, it is unclear whether the claim requires at least one of a flexible material and any structure or if the claim requires at least one of a flexible material and a flexible structure. For examination purposes the limitation is interpreted as requiring at least one of a flexible material and a flexible structure. Examiner suggests amending the claims to recite “…at least one of a flexible material and a flexible structure”.
Appropriate correction is respectfully requested.
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 21-40 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 21 recites the limitation "the surface of a cerebral cortex" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the claim to recite “…in contact with a [[the]] surface of a cerebral cortex…”. Dependent claims inherit the same deficiencies.
Claim 21 recites the limitation "the brain" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the claim to recite “…generated in a [[the]] brain or…”. Dependent claims inherit the same deficiencies.
Claim 21 recites the limitation "the electrode layer" in line 8. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the claim to recite “…other than an [[the]] electrode layer…”. Dependent claims inherit the same deficiencies.
Claim 38 recites the limitation "the flow of the fluid" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the claim to recite “…is unfolded by a [[the]] flow of a [[the]] fluid and an elastic restoring force…”.
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(s) 21, 27, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Negi et al (US 2015/0305643) hereinafter Negi in view of Pepin et al (US 2018/0333571) hereinafter Pepin.
Regarding claim 21, Negi discloses an element ([0030] neural interface 105) comprising:
a contact part (electrode grid 110) configured to be in contact with the surface of a cerebral cortex to measure a signal generated in the brain or transmit an external stimulus to the brain [0030];
a transmitting/receiving part (signal processing unit 120) positioned between a skull and a skin [0033], and
a connection part (cable 130) configured to connect the contact part and the transmitting/receiving part [0034].
Negi fails to disclose wherein the contact part has one or more structures other than the electrode layer that have a serpentine structure. However, Pepin discloses a contact part (electrode assembly 200) having one or more structures other than the electrode layer that have a serpentine structure ([0048] one or more expandable portions 215 may include a polymer material 225 formed in the shape of a structure (e.g., a serpentine)). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Negi with the contact part having one or more structures other than the electrode layer that have a serpentine structure as taught by Pepin. Such a modification would provide the predictable results of allowing for the contact part to be expanded, contracted, opened, or closed, in order to position the contact part and to allow it to move with tissue of a patient’s body (Pepin, [0048]).
Regarding claim 27, Negi discloses wherein at least one of the contact part, the transmitting/receiving part and the connection part is formed in at least one of a flexible material and structure ([0034] the cable 130 can be a thin, highly flexible, biocompatible micro-ribbon cable).
Regarding claim 38, the modified Negi does not teach wherein the contact part has a surface configured such that, when a pressure is applied to a syringe containing the element so as to inject the element into the brain, the surface is unfolded by the flow of the fluid and elastic restoring force of the element. The Examiner submits that these limitations amount to an intended use of the claimed contact part of the element. Intended use language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114(II): "[A]pparatus claims cover what a device is, not what a device does.' Hewlett-Packard Co. .Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus' if the prior art apparatus teaches all the structural limitations of the claim").
In this case, Examiner submits that since modified Negi appears to teach all of the required structural limitations (i.e., contact part has a surface, see Negi Fig. 1A, contact part 110 has upper and lower surfaces) and no further structure appears to be set forth for achieving the intended use of claim 38, modified Negi would be capable of performing the intended use of claim 38.
Moreover, Pepin discloses an electrode assembly being able to be expanded, contracted, opened, and closed [0048]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Negi with the contact part having a surface configured such that, when a pressure is applied to a syringe containing the element so as to inject the element into the brain, the surface is unfolded by the flow of the fluid and elastic restoring force of the element as taught by Pepin. Such a modification would provide the predictable results of allowing the contact part to be positioned correctly (Pepin, [0048]).
Regarding claim 39, Negi discloses a brain signal measurement and stimulation structure comprising: the element according to claim 21 (Figs. 1A-1B; [0030-0033]); and
an integrated circuit (computer circuitry) connected to the transmitting/receiving part to transmit and receive a signal [0033].
Claim(s) 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643) in view of Pepin (US 2018/0333571) and further in view of Rogers et al (WO 2020/092786) hereinafter Rogers.
Regarding claim 22, the modified Negi discloses the system of claim 21 as discussed above, but fails to disclose wherein the serpentine structure has a stretchability of the element that needs to be 50% or more. However, Rogers discloses a serpentine structure having a stretchability of an element that needs to be 50% or more (Pg. 46-47, ln. 31-2). It would have been obvious before the effective filing date of the claimed invention to further modify the system as taught by Negi with a serpentine structure having a stretchability of an element that needs to be 50% or more as taught by Rogers. Such a modification would provide the predictable results of providing high stretchability and compliance with physiological deformations (Rogers, Pg. 46, ln. 26-27).
Regarding claim 23, the modified Negi discloses the system of claim 22 as discussed above, but fails to disclose wherein the serpentine structure has a pattern that is formed in a cycle, wherein the cycle consists of a start point, an end point and an intermediate point, wherein the intermediate point is between the start point and the end point, wherein the pattern between the start point and the intermediate point or between the intermediate point and the end point is formed in an arc shape.
However, Pepin discloses wherein the serpentine structure has a pattern that is formed in a cycle (Fig. 2B),
wherein the cycle consists of a start point, an end point and an intermediate point (see annotated Fig. 2C where a solid arrow points to an intermediate point and the start and end points are encircled),
wherein the intermediate point is between the start point and the end point (see annotated Fig. 2C which shows the dashed arrow pointing to an intermediate point between the encircled start and end points),
wherein the pattern between the start point and the intermediate point or between the intermediate point and the end point is formed in an arc shape (see annotated Fig. 2C where a solid arrow points to an arc shape between the start point and the intermediate point).
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Annotated Fig. 2C: The start/end points are encircled, the solid arrow points to an intermediate part, and the dashed arrow points to an arc shape.
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Negi with the serpentine structure having a pattern that is formed in a cycle, wherein the cycle consists of a start point, an end point and an intermediate point, wherein the intermediate point is between the start point and the end point, wherein the pattern between the start point and the intermediate point or between the intermediate point and the end point is formed in an arc shape as taught by Pepin. Such a modification would provide the predictable results of allowing for the contact part to be expanded, contracted, opened, or closed, in order to position the contact part and to allow it to move with tissue of a patient’s body (Pepin, [0048]).
Regarding claim 24, the modified Negi discloses the system of claim 23 as discussed above, but fails to disclose wherein the serpentine structure is formed in an angle of the arc that needs to be 100 degree or more. However, Pepin discloses wherein the serpentine structure is formed in an angle of the arc that needs to be 100 degree or more (See annotated Fig. 2C above which shows a dashed arrow pointing to the arc which forms an angle of 100 degrees or more). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Negi with the serpentine structure is formed in an angle of the arc that needs to be 100 degree or more as taught by Pepin. Such a modification would provide the predictable results of allowing for the contact part to be expanded, contracted, opened, or closed, in order to position the contact part and to allow it to move with tissue of a patient’s body (Pepin, [0048]).
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643) in view of Pepin (US 2018/0333571) and Rogers (WO 2020/092786) and further in view of Lu et al (WO 2018/231444) hereinafter Lu.
Regarding claim 25, the modified Negi discloses the system of claim 24 as discussed above, but fails to disclose wherein the serpentine structure has a ratio of a width of the pattern to a radius of the arc, wherein the ratio needs to be 0.3 or less. However, Lu discloses wherein the serpentine structure (Fig. 1) has a ratio of a width of the pattern to a radius of the arc, wherein the ratio is between 0.4 and 0.8 [0020]. Examiner submits that the claimed 0.3 or less range is so close to the taught 0.4 ratio value that a prima facia case of obviousness exists. One of ordinary skill in the art would expect a serpentine structure with a ratio of 0.3 or less to have the same properties as a serpentine structure with a ratio of 0.4 as taught by Lu '444 (see MPEP 2144.05(I): "Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of 'having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium' as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. 'The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.' See also Warner-Jenkinson Co., Inc. V. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)).
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643) in view of Pepin (US 2018/0333571) and further in view of Yarmush et al (US 2013/0245416) hereinafter Yarmush.
Regarding claim 26, the modified Negi discloses the system of claim 21 as discussed above, but fails to disclose wherein the element has a porosity of 25 to 60%. However, Yarmush discloses wherein an element (electrode tip) has a porosity between approximately 26% and approximately 38%. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Negi with the element having a porosity of 25 to 60% as taught by Yarmush. Such a modification would provide the predictable results of reducing the impedance (Yarmush, [0041]).
Claim(s) 28 and 33-37 are rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643) in view of Pepin (US 2018/0333571) and further in view of Lu et al. (Lu, Y., Lyu, H., Richardson, A. G., Lucas, T. H., & Kuzum, D. (2016b). Flexible neural electrode array based-on porous graphene for cortical Microstimulation and sensing. Scientific Reports, 6(1)) hereinafter Lu NPL.
Regarding claim 28, the modified Negi discloses the system of claim 1 as discussed above, but fails to disclose the element further comprising a lower-layer support substrate; a graphene electrode layer and a wiring layer formed on the lower-layer support substrate; and an insulation layer formed on the graphene electrode layer and the wiring layer.
However, Lu NPL discloses a flexible neural electrode array based on graphene for cortical microstimulation and sensing (Title) wherein a flexible electrode comprises a lower-layer support substrate, a graphene electrode layer (Fig. 1a-b depicts laser pyrolysis on polyimide substrate to form graphene electrodes; see pg. 2, "Results and Discussion") and a wiring layer formed on the lower-layer support substrate (Fig. 1b depicts addition of Au metal interconnects, see pg. 2 "Results and Discussion"), and an insulation layer formed on the graphene electrode layer and the wiring layer (Fig. 1c depicts addition of etched SU-8 insulation layer to graphene electrodes and wiring, SU-8 layer being etched such that each graphene electrode is exposed; see also pg. 2 "Results and Discussion").
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Negi with the element further comprising a lower-layer support substrate; a graphene electrode layer and a wiring layer formed on the lower-layer support substrate; and, an insulation layer formed on the graphene electrode layer and the wiring layer as taught by Lu NPL. Such a modification would provide the predictable results of the porous graphene electrodes showing superior impedance and charge injection characteristics as well as avoiding physical delamination or degradation (Lu NPL, Abstract).
Regarding claim 33, the modified Negi discloses the system of claim 28 as discussed above, but fails to disclose wherein the insulation layer is etched such that at least part of the graphene electrode layer is exposed, and at least part of the graphene electrode layer and at least part of the wiring layer are adjacently connected. However, Lu NPL discloses wherein the insulation layer is etched such that at least part of the graphene electrode layer is exposed (Fig. 1c depicts addition of etched SU-8 insulation layer to graphene electrodes and wiring, SU-8 layer being etched such that each graphene electrode is exposed; see also pg. 2 "Results and Discussion"), and
at least part of the graphene electrode layer and at least part of the wiring layer are adjacently connected (Fig. 1b depicts interconnection of wiring and graphene electrodes).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Negi with the insulation layer is etched such that at least part of the graphene electrode layer is exposed, and at least part of the graphene electrode layer and at least part of the wiring layer are adjacently connected as taught by Lu NPL. Such a modification would provide the predictable results of the porous graphene electrodes showing superior impedance and charge injection characteristics as well as avoiding physical delamination or degradation (Lu NPL, Abstract).
Regarding claim 34, the modified Negi discloses the system of claim 28 as discussed above, but fails to disclose wherein the lower-layer support substrate is formed of one selected from the group consisting of polyethylene terephthalate (PET), polyimide (PI), polystyrene (PS), polycarbonate (PC), polyethersulfone (PES), polymethylmethacrylate (PMMA) cyclo-olefin polymers (COP), polydimethylsiloxane (PDMS), polyvinylpyrrolidone (PVP), polyethylene naphthalate (PEN), polyvinyl chloride (PVC), and a mixture thereof. However, Lu NPL discloses wherein the lower-layer support substrate is formed of polyimide (PI) (Lu NPL, pg. 2, under “Results and Discussion”). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Negi with the lower-layer support substrate being formed of polyimide (PI) as taught by Lu NPL. Such a modification would provide the predictable results of the element exhibiting drastically low impedance, high charge injection capacity and flexibility making them ideal for cortical recording and microstimulation (Lu NPL, pg. 2, Abstract).
Regarding claim 35, the modified Negi discloses the system of claim 28 as discussed above, but fails to disclose wherein the graphene electrode layer comprises one to four layers, and has a diameter of 30 to 150 µm. However, Lu NPL discloses wherein the graphene electrode layer comprises one to four layers (Fig. 1 shows the graphene electrode layer comprising between one and four layers) and has a diameter of 250 µm (Pg. 2, under “Results and Discussion”).
It would have been obvious before the effective filing date to modify the system as taught by Negi with the graphene electrode layer comprising one to four layers as taught by Lu NPL. Such a modification would provide the predictable results of the porous graphene electrode showing superior impedance and charge injection characteristics as well as avoiding physical delamination or degradation (Lu NPL, Abstract). Moreover, Examiner submits that the claimed 30 to 150 microns range is so close to the taught 250 microns that a prima facia case of obviousness exists. One of ordinary skill in the art would expect a graphene layer with a 250-micron diameter to have the same properties as a graphene layer with 30-to-150-micron diameter (MPEP 2144.05(I): "Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of 'having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium' as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. 'The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.' See also Warner-Jenkinson Co., Inc. V. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)).
Regarding claim 36, the modified Negi discloses the system of claim 28 as discussed above, but fails to disclose wherein the wiring layer is formed of one selected from the group consisting of gold (Au), silver (Ag), copper (Cu), nickel (Ni), and iron (Fe), and has a thickness of 30 to 60 nm. However, Lu NPL discloses wherein the wiring layer is formed of gold (Au) (Pg. 2, under “Results and Discussion”), and has a thickness of 100nm (Pg. 2, under “Results and Discussion”). It would have been obvious before the effective filing date to modify the system as taught by Negi with the wiring layer being formed of gold as taught by Lu NPL. Such a modification would provide the predictable results of a low impedance connection and efficient electron transfer. Moreover, Examiner submits that the claimed thickness of 30 to 60 nm is so close to the taught 100nm that a prima facia case of obviousness exists. One of ordinary skill in the art would expect a wire with a thickness of 100nm to have the same properties as a wire with a thickness of 30 to 60nm (MPEP 2144.05(I): "Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of 'having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium' as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. 'The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.' See also Warner-Jenkinson Co., Inc. V. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)).
Regarding claim 37, the modified Negi discloses the system of claim 28 as discussed above, but fails to disclose wherein the insulation layer is formed of one selected from the group consisting of optical clean resin (OCR), optical clean adhesive (OCA), SU-8, and a mixture thereof. However, Lu NPL discloses wherein the insulation layer is formed of SU-8 (Fig. 1c caption; Pg. 2, under “Results and Discussion”). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Negi with the insulation layer being formed of SU-8 as taught by Lu NPL. Such a modification would provide the predictable results of allowing a precise patterning of the insulation layer (Lu NPL, Pg. 2, under “Results and Discussion”).
Claim(s) 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643) in view of Pepin (US 2018/0333571) and Lu NPL (Lu, Y., Lyu, H., Richardson, A. G., Lucas, T. H., & Kuzum, D. (2016b). Flexible neural electrode array based-on porous graphene for cortical Microstimulation and sensing. Scientific Reports, 6(1)) and further in view of Byun et al (KR 2012-0077585) hereinafter Byun.
Regarding claim 29, the modified Negi discloses the system of claim 28 as discussed above, but fails to disclose wherein a surface of the insulation layer undergoes hydrophilic surface treatment. However, Byun discloses wherein a surface of an insulation layer undergoes hydrophilic surface treatment (Pg. 4, last para.). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Negi with a surface of the insulation layer undergoing hydrophilic surface treatment as taught by Byun. Such a modification would provide the predictable results of providing firm contact with another component of the electrode (Byun, Pg. 4, last para.).
Regarding claim 30, the Examiner submits that this is a product-by-process claim which claims a specific process of making a surface of the insulation layer hydrophilic. As per MPEP 2113(I): ""[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.' In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v.F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009).
In this case, the teachings of Byun provide the hydrophilic surface as described in the rejection of claim 29 above. The prior art thus meets the required structure and even though made by a different process, claim 30 is nevertheless read upon by the modified Negi as applied to claim 29.
Claim(s) 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643) in view of Pepin (US 2018/0333571) and Lu NPL (Lu, Y., Lyu, H., Richardson, A. G., Lucas, T. H., & Kuzum, D. (2016b). Flexible neural electrode array based-on porous graphene for cortical Microstimulation and sensing. Scientific Reports, 6(1)) and further in view of Scheuermann (US 2010/0125319).
Regarding claim 31, the modified Negi discloses the system of claim 28 as discussed above, but fails to disclose wherein a partial surface of the lower-layer support substrate undergoes hydrophobic surface treatment. Scheuermann, however, teaches a cell-repelling electrode (Abstract) wherein one or more electrodes includes a structured surface configured to exhibit hydrophobic qualities. The hydrophobic qualities advantageously inhibit tissue in growth and/or attachment to the electrode surface [0024]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Negi with a partial surface of the lower-layer support substrate undergoing hydrophobic surface treatment as taught by Scheuermann. Such a modification would provide the predictable results of inhibiting tissue in growth and/or attachment to the electrode surface (Scheuermann, [0024]).
Regarding claim 32, Examiner submits that this is a product-by-process claim which claims a specific process of making a surface of the support substrate hydrophobic. As per MPEP 2113(I): ""[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v.F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009).
In this case, modified Negi along with the teachings of Scheuermann provides the hydrophobic surface as described in the rejection of claim 31 above. The prior art thus meets the required structure and even though made by a different process, claim 32 is nevertheless read upon by modified Negi as applied to claim 31.
Claim(s) 40 is rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643) in view of Pepin (US 2018/0333571) and further in view of Khayrullaev et al (US 2018/0317875) hereinafter Khayrullaev.
Regarding claim 40, Negi teaches an integrated circuit comprising a recording device and a stimulation device [0049], but fails to disclose wherein the integrated circuit comprises a wireless power supply device and a communication device. Khayrullaev, however, teaches a system for telemetrically monitoring a subject (Abstract) wherein a printed circuit board (PCB) includes a transceiver and wireless power charge unit [0034]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Negi with an integrated circuit comprising a wireless power supply device and a communication device as taught by Khayrullaev. Such a modification would provide the predictable results of facilitating remote monitoring as well as wireless charging in order to promote patient mobility.
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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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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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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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