DETAILED ACTION
This action is pursuant to the claims filed on February 20, 2025. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
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 . 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 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.
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 1-15 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “a ROSE probe comprising… one or more shanks… and wherein the one or more shanks are positioned in rows and separated by a space having a pitch.” However, the claim can broadly include a single shank and a single shank cannot reasonably be considered to provide a space having a pitch, as required in the claim since a space necessarily requires the presence of at least two distinct shanks.
Accordingly, claims 2-15 is rejected by virtue of its dependency on claim 1.
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 1-3, 10-11, 14-16 and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Kim et al. (hereinafter ‘Kim’ U.S. PGPub. No. 2017/0020403).
In regards to claim 1, Kim discloses a rolling-of-soft-electronics (ROSE) probe (nerve probe array 1 in Fig. 1) comprising:
a planar component (connector 10 made of a flexible material, [0051]) comprising one or more shanks (a plurality of probes 20, [0050]); and
one or more electrodes (a plurality of electrodes 213, [0052]) disposed on the one or more shanks (electrodes 213 disposed along the probes 20 as shown best in Fig. 2);
wherein the one or more shanks are positioned in rows and separated by a space having a pitch (Fig. 7 illustrates exemplary planar configuration of the array 1 in which the probes 20 are arranged in rows and separated by a space, each having a distal tapering tip inherently comprising pitches or slopes to form the tapering tip).
In regards to claim 2, Kim further discloses the planar component further comprises at least one substrate layer and at least one encapsulation layer ([0050]: the connector 10 is made of a flexible material such as a polymer which read on the at least one substrate layer and coated with a flexible material such as polyimide, parylene, silicon, epoxy or the like which reads on the at least one encapsulation layer).
In regards to claim 3, Kim further discloses wherein the planar component is rolled such that the one or more shanks are circularly arranged in three-dimensions ([0070]: FIG. 3 shows an example in which the nerve probe array 1 according to this embodiment is connected to the nerve N. FIG. 3 shows that the nerve N is cut in a direction perpendicular to a length direction thereof in which the array 1 is arranged is rolled in a circular manner to surround the nerve).
In regards to claim 10, Kim further discloses wherein from 1 to 256 electrodes are disposed on each of the one or more shafts (at least four electrodes 213 are disposed along the probe in Fig. 2).
In regards to claim 11, Kim further discloses a spacer layer disposed on a base of the planar component and configured to act as a spacer between the rows ([0050]: the connector 10 is made of a flexible material such as a polymer which reads on the base of the planar component and coated with a flexible material such as polyimide, parylene, silicon, epoxy or the like which reads on the spacer layer; the examiner notes that each of the shanks and its corresponding electrical interconnects form a plurality of rows as shown in exemplary Fig. 7 and disposed in between the probes 20 are the planar component or connector 10 which includes the coating flexible material).
In regards to claim 14, Kim further discloses a connector pad matrix which comprises interconnects of the one or more electrodes (Fig. 2 illustrates a cable 214 is electrically connected to each of the electrode 213 and the cable 214 extends along the connector 10 to be electrically connected to a signal processor, [0053]).
In regards to claim 15, Kim discloses a method of using the ROSE probe of claim 1 as a neural probe ([0050]: the probes 20 are configured to be disposed in a nerve).
In regards to claim 16, Kim discloses a rolling-of-soft-electronics (ROSE) method comprising:
providing a planar component comprising one or more shanks and one or more electrode disposed on the one or more shanks ([0008]: as an example of the subminiature nerve electrode structure, a cuff electrode composed of a body having a broad area and made of a flexible material and an electrode embedded in the body is used; [0033]: the plurality of probes may be made of a flexible material or coated with a flexible material at a surface thereof.; [0051]:even when the body 210 of the probe 20 is made of a flexible material, the body 210 may have sufficient rigidity so that the probe 20 may be inserted into the nerve N; these parts of the reference discloses that the flexible material forms the probes 20 and supports the electrodes 213 along the probes as shown in exemplary Fig. 2);
fixing a micro-mandrel to the edge of the planar component ([0094] The jig 2 has a cylindrical body 3, and the body 3 has a thin slit 4 into which the connector 10 and the probe 20 may be inserted. The slit 4 is spirally formed along the length direction of the body 3 and is perfectly opened so that the outer circumference of the nerve N is exposed through the slit 4; note that the jig 2 is a micro-mandrel in which the edge of the array 1 is connected to for fixing the array 1 as intended along the nerve N as shown in exemplary Fig. 6B);
rolling the planar component so that the one or more shanks are circularly arranged in three-dimensions to generate a ROSE probe ([0094]: Fig. 6B shows that the array 1 is rolled in a manner along the jig 2to provide a three-dimensional arrangement along the nerve N).
In regards to claim 20, Kim further discloses wherein from 1 to 256 electrodes are disposed on each of the one or more shafts (at least four electrodes 213 disposed along the probe in Fig. 2).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 9, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kim.
In regards to claims 9 & 19, Kim further discloses the invention substantially as claimed claim 1 and discussed above except for the ROSE probe comprising from 10-1,000 shanks.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the number of shanks on the ROSE probe (currently 8 probes as shown in exemplary Figs. 1-3) to be more than 10 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. One would have done so to gather nerve information from a larger area of the nerve.
In regards to claim 12, Kim further discloses substantially all the limitations as set forth in claim Kim further discloses the invention substantially as claimed claim 11/1 and discussed above except for the spacer layer material being a polydimethylsiloxane (PDMS) layer.
However, Kim discloses that the spacer layer material can be polyimide, parylene, silicon, epoxy or the like ([0050]: coated material is interpreted to be the spacer layer material). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use PDMS as the coating or spacer layer material since the equivalence of polyimide, parylene, silicon, epoxy and PDMS for their use in the flexible medical device art and the selection of any one of these known equivalents to coat or insulated flexible printed circuit board in the medical area would be within the level of ordinary skill in the art.
Claims 4, 6, 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of Masmanidis et al. (hereinafter ‘Masmanidis’, U.S. PGPub. No. 2009/0177144).
In regards to claims 4, 8 and 13, Kim discloses the invention substantially as claimed in claim 1 and discussed above except the planar component has a thickness from 1-100 um and the one or more shanks has a thickness from 2-100 um, and the spacer layer has a thickness of 100-1,000 um.
Masmanidis teaches generally a micro-electro-mechanical systems specifically to neural device ([0011]). Masmanidis teaches forming the neural device from a planar substrate similar to Kim has a thickness of 50 um and explains that normally, substrate thickness is less than about 150 um, 100 um, 50 um or 25 um. In addition, Kim explains that the substrate material may be semiconductor (e.g., gallium arsenide or silicon carbide) or non-semiconductor (e.g., glass, organic polymer, such as parylene, diamond, plastic, ceramic) substrates ([0023] & [0035]). Given that Kim is silent as to the thickness of the planar substrate, the one or more shanks, and/or the spacer layer, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to form the ROSE probe from a planar substrate having a thickness that is generally less than about 100 um and the spacer layer (e.g. coating layer) to be 100 um, 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. In addition, the use of a flexible material having the claimed thickness to be used as a substrate and/or and for coating/encapsulating/insulating is known in the art and a predictable result of insulating the conductive components (e.g. interconnects and electrodes) along the array and providing sufficient mechanical strength for its intended purpose of being insertable into a neural tissue would ensue.
In regards to claim 6, Kim discloses the invention substantially as claimed in claim 1 and discussed above. However, Kim is silent as to the one or more shanks having a width from 10-1,000 um.
Masmanidis teaches generally a micro-electro-mechanical systems specifically to neural device ([0011]). Masmanidis teaches forming the neural device comprising a plurality of shanks, where each of the shanks has a width of about 100 um (see Fig. 3B). Given that Kim is silent as to the width of the shanks, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide the shanks with the claimed width, 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. Optimization of the width based upon the number of electrodes and interconnects/traces to provide a desired spatial resolution for recording/stimulation involves routine skilled in the art.
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 or 16 above, and further in view of Hegde et al. (hereinafter ‘Hegde’, U.S. PGPub. No. 2011/0295100).
In regards to claim 5 & 18, Kim discloses the invention substantially as claimed in claim 1 or 16 and discussed above.
However, Kim is silent as to the one or more shanks comprising a tapered profile with a tip angle of 20 degrees.
Hegde generally discloses a plurality of microneedles extending from a substrate (microneedles 28 extending from a substrate 22 in Fig. 2A). Hedge specifically discloses that the needle tip may be tapered and may be sharp like a "needle point" and having the needle taper angle of about 45 deg or between 2 deg to 60 deg. Furthermore, the needle can any shape i.e. round, rectangular, trapezoidal, triangular, or any regular or irregular shape ([0071]). Given that Kim is silent as to the tapered profile having the claimed angle, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention before the effective filing date of the invention to modify the tapered profile of the shank having the claimed angle as modifying the shape and taper angle between 2 deg to 60 deg for penetrating into a tissue is known in the art.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of Pepin et al. (hereinafter ‘Pepin’, U.S. PGPub. No. 2018/0272126).
In regards to claim 7, Kim discloses the invention substantially as claimed in claim 1 and discussed above.
However, Kim is silent as to wherein each of the one or more shanks has a length from 0.5-0 mm.
Pepin teaches an electrode cuff similar to Kim comprising a plurality of shanks configured to be inserted into an epineurium of a nerve where the length of the shank can have a length greater than 16 um ([0045]). Given that Kim is silent as to the length of the shanks, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide the shanks with the claimed length, 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. Optimization of the length based upon the nerve size so that the shank is configured to penetrate into the epineurium of a large nerve for recording/stimulation involves routine skilled in the art.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 or 16 above, and further in view of Liu et al. (hereinafter ‘Liu’, U.S. PGPub. No. CN 111053535).
In regards to claim 17, Kim discloses the invention substantially as claimed in claim 16 and discussed above. However, Kim does not disclose that the planar component comprises an adhesive portion configured to be secured around the ROSE probe.
Liu teaches a method of forming a neural probe comprising a flexible substrate and disposing an adhesive layer and a conductive layer in which the adhesive layer is set on the flexible substrate to adhere the conductive layer onto the flexible substrate (claim 7: the mentioned a kind of biological implant for flexible stretchable neural probe, wherein, the metal wire layer comprises an adhesion layer and a conductive layer, the upper surface of the adhesive layer is set on the first flexible polymer layer, the conducting layer is set on the upper surface of the adhesive layer). Given that Kim is silent as to how the conductive interconnects and electrodes are attached to the planar substrate, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide an adhesive layer as taught by Liu so that the interconnects and electrodes of Kim can be attached to the planar component and the shanks. The examiner notes that the limitation ‘secured around the ROSE probe’ is broadly claimed at that the adhesive layer is configured to be secured around the planar component and the shanks where the interconnects and electrodes are positioned.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 7/30/2026
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