DETAILED ACTION
This action is pursuant to the claims filed on July 24, 2024. Claims 1-11 are pending. A first action on the merits of claims 1-11 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.
Claim 6-10 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 6 recites “the metal lead electrodes”. However, there is insufficient antecedent basis for said limitation. For the purposes of examination and applying prior art, the examiner will apply art based that the metal lead electrodes are metal lead interconnects as encapsulating electrodes would render the device inoperable for its intended purpose for contacting a site for stimulation/recording.
Accordingly, claims 7-10 are rejected by being dependent on claim 6.
Appropriate 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 1-3, and 11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Finneran et al. (hereinafter ‘Finneran’, U.S. PGPub. No. 2004/0054273, cited in IDS).
In regard to independent claim 1 and claim 3, Finneran discloses a microelectrode grid (electrode array 280 in Fig. 43, [0103]) for continuous interoperative neuromonitoring ([0106]: the array 280 is configured for EMG diagnostics):
a flexible substrate (substrate 282 in Fig. 43 with a portion of the flexible array being shown throughout Figs.44- 47);
a plurality of low impedance electrochemical interface material (hydrogel 308 shown in Figs. 44-45) on conducting metal pads (Fig. 43 labels the electrodes 284 while Figs. 44-45 labels the electrodes 304) on the substrate ([0107] & [0118]: a self-supporting adhesive 308 such as hydrogel is stenciled over each printed electrode to provide additional electrical conductivity between the surface of the patient and the printed electrodes), the metal pads being interconnectable to stimulation/acquisition electronics through the metal lead interconnects forming stimulation and recording channels and eventually to bonding pads (each of the electrodes 284 as best shown in Fig. 43 is connected to a corresponding electrical traces 286 and down to a connection point 299 which allows for the traces to be connected to an external electrical connector for EMG diagnostics ([0123]), the interconnects being insulated with dielectric ([0109]: the traces are insulated by printing additional layers of a non-conductive ink 312 over the traces; note that the claim does not specify a particular material and that an insulative ink polymerized and configured to contact a wearer’s skin is a biocompatible polymer material, thus meeting claim 3); and
a flap within the substrate (in an exemplary portion of the array as shown in Fig. 47, perforations 324 along the electrode 322 of the electrode array moves the electrode 322 away from the substrate portion 330 that is part of the substrate 282 in Fig. 430, [0114]-[0115]), the flap being movable away from the remainder of the substrate while at least some of the metal pads on the remainder of the substrate can remain in contact with an organ when the flap is moved away from the remainder of the substrate (the flap comprising the stem portion 323 and electrode supporting portion 325 in Fig. 47 is movable from the rest of the substrate portion 330).
In regards to claim 2, Finneran further discloses wherein the remainder of the substrate comprises surrounding microelectrode recording channels outside the flap (the rest of the electrodes disposed along the susbtrate 282 other than the electrode disposed on the portion 330 as shown in Fig. 47), the surrounding microelectronic channels being capable of continuously monitoring during surgery (this limitation is intended use and the array is capable of being used for monitoring EMG during a surgical procedure).
In regards to claim 5, Finneran further discloses wherein the flap comprises a hinge and the metal lead interconnects for the at least some of the metal pads are routed through the hinge (the hinge is the portion where the stem 323 and the substrate 330 intersect as shown in Fig. 47 and the trace 326 is routed through the hinge or fold).
In regards to claim 11, the examiner notes that the limitation is directed to intended use and that the flap as shown in Fig. 47 and its resulting perforation on the substrate is capable of providing a surgical access site depending upon the size of a surgical tool that is used by a surgeon.
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 4 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Finneran as applied to claim 1 above, and further in view of Laude et al. (hereinafter ‘Laude’, U.S. PGPub. No. 2008/0085376, cited in IDS).
In regards to claim 4, and 6-10, Finneran discloses the invention substantially as claimed in claim 1 and discussed above.
However, Finneran does not disclose wherein the substrate and dielectric are unitary flexible polymer that encapsulates the metal lead electrodes, wherein the unitary flexible polymer defines a sensing portion including the conducting metal pads, the flap and portions of the metal lead interconnects, a neck portion that extends away from the sensing portion, and a circuit connection portion that includes the bonding pads, wherein the sensing portion comprises through-holes for intimate contact with an organ during surgery.
Laude teaches an electrode array (a flexible circuit electrode array in Fig. 9) comprising a unitary flexible polymer (silicone containing polymer 3 as shown in Fig. 8), wherein the unitary flexible polymer encapsulates metal traces (traces 5 in Fig. 8, specifically as shown in Fig. 34A, [0011], [00097]). Laude further discloses providing a through-hole (hole 6 in Fig. 34B) along the flexible polymer to expose the trace (5) and providing a conducting metal pad (metallization 7 in Fig. 34C) to form a sensing portion (see Fig. 34B, [0152]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the substrate and dielectric of Finneran to provide a unitary flexible polymer such that the unitary flexible polymer encapsulates the metal lead electrodes as taught by Laude and thereby define all the claimed features of the substrate using a single polymeric material and to fully protect, cover and insulate the interconnects ([0070]).
In regards to claim 7, in view of the combination in claim 6, Finneran/Laude combination meets the limitation since the substrate (330 in Fig. 47) including the flap (including portions 325 and 323) would all be formed from the unitary flexible polymer of Laude. In addition, the metal lead interconnects and a circuit connection portion that includes the bonding pads of the flap portion would all be embedded in the flexible polymer of Laude.
In regards to claim 9, Finneran/Laude combination further discloses wherein the neck portion (the width of stem 323 in Fig. 47) is narrower than both the sensing portion (the width of the section 325 in Fig. 47) and the circuit connection portion (the trace of the stem 323 extends to the connection point 299, and the point 299 (shown in Fig. 43) is greater in width than the stem section 323).
In regards to claim 10, Finneran/Laude combination further discloses wherein the neck portion has a length to extend the circuit connection portion away from a surgical site (the stem 323 in Fig. 47 can be configured to move away from the substrate 330, and depending upon the surgical site relative to the substrate 330, the stem 323 is capable of moving away from the surgical site), and permit a surgeon to operate without impedance from electronics connected to the circuit connection portion (the surgeon is capable of operating on a surgical site without impedance from electronics, external EMG diagnostics, when the electronics is off, [0123]).
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 6/3/2026
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