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 filed 2/6/26 have been fully considered but they are not persuasive.
The amendments relate to: a) the lead wire being connected through two channels of the top of the electrode, b) the top of the electrode extending from one side of the substrate, and c) the base of the electrode extending from an opposite side of the substrate. The first part (a), is taught by Clark, as was also noted in the parent application. The second part (b), is already taught by Copp-Howland, as the eyelet electrode partially extends from the top side of substrate 36. The third part (c), is taught by Parent, which teaches securing a gel pad with an electrode that includes a top above the gel pad and a base below the gel pad. Thus, the amendments are taught by the prior art, as further discussed below.
Applicant’s arguments in relation to Zekrich and Claim 14 are moot, as Zekrich is not part of the instant rejections and Claim 14 was canceled, while the amendments to Claim 1 change the scope from all previously presented claims. Nevertheless, it is noted that attempts to discredit KSR motivational statements, as directed to “general motivation”, lack legal and evidentiary basis. MPEP 2144.I: “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); see also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner must present convincing line of reasoning supporting rejection); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning).”
The legal precedent set by KSR is further explained in MPEP 2143, where it is stated that:
“Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list.”
There is no legal basis on record that would support arguments that rationales A through E of KSR are “general” and thus insufficient.
It is further noted that new Claim 21 presents a shift in invention, and is withdrawn as directed to a shift in invention from the constructively elected invention of prosecuted claim 1, as further discussed below.
Election/Restrictions
Under Rule 145 and 142(b), newly submitted claim 21 is directed to an invention that is independent or distinct from the invention originally/previously claimed for the following reasons:
Amended Claim 21 is directed to an invention (II) that is independent or distinct from the invention (I) previously examined (previously presented Claim 1). The inventions as claimed have a materially different design, mode of operation, function, or effect since certain limitations in one of the groups find no counterpart in the other group(s) and vice versa. Invention II does not require the limitations of, inter alia, the pledget substrate having a first surface that is hydrophilic, as found in invention I. In addition, Invention I does not require the limitations of, inter alia, the electrode having a base extending from a first side of the pledget substrate and a top opposite the base extending from a second side of the pledget substrate, the first side being opposite the second side and the top defining first and second channels, the lead wire disposed in the first channel, extending out of the top, and then extending into the second channel, as found in invention II.
The Office does not permit a shift in invention during prosecution, see Rule 145, MPEP 819, 821.03. Since applicant has received an action on the merits for the previously presented invention, this invention has been constructively elected by original presentation for prosecution on the merits.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 21 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Claims 1, 6, 8, 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0282188 by Copp-Howland (cited previously), in view of GB 2131297 A to Clark and US 4441501 to Parent.
Regarding Claim 1, Copp-Howland discloses an electrode assembly capable of intraoperative use (e.g. Fig. 3: the electrode would be capable of use in an intraoperative field, and Copp-Howland meets all the structures recited in the body of the claim, thus it must meet any intended uses or results, including the nominal language of the preamble, else the claims are incomplete for failing to recite aspects essential to the invention) comprising:
a substrate capable of use as a pledget having a first surface that is hydrophilic (e.g. Fig. 3, title, par. 26: conductive hydrogel polymer layer 36 is hydrophilic and hydrogels can absorb liquids; par. 53: wound treatment electrode for accelerated healing of skin wounds, also capable of drug delivery);
a first electrode supported by and extending through the pledget substrate, the first electrode having a base and a top opposite the base extending from a second side of the pledget substrate (e.g. Fig. 3, par. 50: conductive eyelet 35 with a top extending from the top side of backing 32, ie. any or all portions of 34/35 that lie above hydrophilic layer 36, the base being the portion on 35 that extends below layer 32 and extends within layer 36); and
a lead wire assembly interconnected to the first electrode (e.g. par. 49-50, 53: electrical and mechanical connection to external monitoring EEG/ECG/TENS to the snap connector 34).
Copp-Howland does not disclose the top defining first and second channel, wherein the lead wire assembly is received in the first channel, extends out of the top, and then into the second channel.
However, Clark teaches an analogous electrode which includes a top having first and second channels (lines 18-21, Fig. 4: electrode 10 with top protruding boss 11 having channels 14 and 15), wherein the lead wire assembly is received in the first channel, extends out of the top and then into the second channel (as clearly shown in Fig. 2, a part of the wire is held in channel 14, and another part of the wire extends out of the boss 11 and into channel 15; Also see lines 73-87). Clark further teaches that this configuration prevents early failure and would allow an unskilled person to easily replace the wiring (lines 22-31, 95-97). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a dual channel wire holding arrangement in the top of the electrode in a device according to the teachings of Copp-Howland, as taught by Clark, as: a) this would predictably connect the lead wire to the electrode, and b) Clark teaches that this option would prevent early failure of the electrode device and would allow an unskilled person to easily replace the wiring (lines 22-31, 95-97).
Copp-Howland does not disclose the base of the first electrode extending from a second side of the pledget substrate.
However, Parent teaches an analogous electrode which extends throughout both a supportive layer and a gel pad, its top extending above these layers and its base extending below these layers (e.g. abstract: “eyelet of a snap fastener conductor extends both through an adhesively coated supporting sheet and a gel pad”, 3:59—4:11, Fig. 1: base flange 30 extends below gel pad 22 and top 32/24 extends above the gel pad 22 and support layer 18). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a base flange that extends from the bottom side of the substrate of an electrode according to the teachings of Copp-Howland, as taught by Parent, as this would only amount to an equivalent mechanism to predictably secure the eyelet electrode to the substrate, and do so as to ensure that the hydrophilic substrate does not fall off from the rest of the electrode, as suggested by Parent (2:10-18).
Regarding claim 6, Copp-Howland as modified in Claim 1 teaches the electrode assembly of claim 1, wherein a material is a porous material (e.g. par. 26: hydrogels are porous).
Regarding claim 8, Copp-Howland as modified in Claim 1 teaches the electrode assembly of claim 1, wherein the pledget substrate includes a coating (e.g. Fig. 3, par. 45: coating 38 which is silicone coated PET).
Regarding claim 10, Copp-Howland as modified in Claim 1 teaches the electrode assembly of claim 1, further comprising a connector configured to be connected to a nerve monitoring system (e.g. par. 49-50, 53: electrical and mechanical connection to external monitoring EEG/ECG/TENS to the snap connector 34).
Regarding claim 18, Copp-Howland as modified in Claim 1 teaches the electrode assembly of claim 1, wherein the first electrode an axle interconnecting the top and base (e.g. Fig. 3: axle 35 connects a top 32/33/34 with a base 36/38).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Copp-Howland/Clark/Parent, as applied to Claim 1, and further in view of US 4653501 to Cartmell and US 3750094 to Zenkich (cited previously).
Regarding Claim 2, Copp-Howland as modified in Claim 1 teaches the electrode assembly of claim 1, yet does not explicitly disclose that the lead wire assembly includes at an insulating jacket positioned around a wire core, the first electrode further including an insulating cup interconnecting the first electrode and the insulating jacket. As a matter of interpretation, note that “interconnecting” does not require direct contact. However, it is well known in the art to include insulation jackets in electrode lead wires, and one such example is taught by Cartmell (e.g. 5:13-16). Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an insulating jacket in a device according to the teachings of Copp-Howland, as taught by Cartmell, in order to predictably transmit electrode signals between the electrode and the external monitor without the losses, interference, damage and safety issues associated with naked wires. Furthermore, Zenkich teaches an analogous electrode which uses a cup with an insulator to removably connect the lead wire to the electrode (Fig. 3,5, 3:25-30: connector 16 includes plastic plug 60, removably connects the top 36 of the electrode with the lead wire 18, and can be read as a cup, ie. a small open container). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an electrode cup connector with an insulator to removably connect the electrode stud with the lead wire in a device according to the teachings of Copp-Howland, as taught by Zenkich, in order to predictably connect the electrode with the lead wire, and as Zenkich teaches (1:27-35), this would provide the benefit of “an electrode assembly that may be readily releasably detached without detracting from the good electrical conductivity of the assembly or significantly increasing the complexity of the electrode-connector combination” and that “also permits the electrode portions themselves to be inexpensively made so that they may be disposed of after a single use”.
Regarding Claim 3, Copp-Howland as modified in Claim 2, teaches the electrode assembly of claim 2, wherein the insulating cup is configured to rotate about the pledget substrate (Zenkich, 3:55-57).
Claims 4-5, 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Copp-Howland/Clark/Parent, as applied to Claim 1, and further in view of US 20030088239 by Takaki (cited previously).
Regarding Claims 4-5, Copp-Howland discloses that the pledget substrate includes a PET blend (par. 45), but does not explicitly disclose a rayon and PET blend or an explicitly lint free material (the specification notes that rayon/PET is considered a lint free material). However, Takaki teaches an analogous electrode device that absorbs skin liquids, and further includes a polyester and cellulose fabric fibers (aka PET and rayon) in the electrode pad substrate (par. 162; Fig. 2: layer 16 is rayon/PET). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate rayon and PET fibers in an electrode according to the teachings of Copp-Howland, as taught by Takaki, as this would only amount to a selection among known electrode materials for skin electrodes, the material is breathable, absorbent and can be used to incorporate conductive means, and the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art (In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding Claims 9 and 13, Copp-Howland as modified in Claim 1 teaches the electrode assembly of claim 1, and further teaches that the first side of the pledget substrate includes a hydrophilic first coating, which includes water, and a binder (e.g. Fig. 3, title, par. 26: conductive hydrogel polymer layer 36 is hydrophilic; par. 35: crosslinking agents) yet does not explicitly disclose that the second side of the pledget substrate includes a hydrophobic coating, or that some of the coatings of the substrate includes a surfactant. However, Takaki teaches an analogous electrode device that absorbs skin liquids, and further includes a hydrophobic upper layer (e.g. abstract, par. 23-24; par. 109, 127-138 are dedicated to surfactants used in both layers). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a hydrophobic layer in an electrode according to the teachings of Copp-Howland, as taught by Takaki, in order to protect the metal portions of the device from corrosion, to remove oily insulating molecules from the hydrogel, and as Takaki suggests in order to enhance the mechanical stability of the substrate (par. 23-24). It would also have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add a surfactant to the hydrogel in a device according to the teachings of Copp-Howland, as taught by Takaki, in order to stabilize and control the size of each layer (Takaki, par. 51, 64) and to prevent body fluids from changing the properties of the electrode assembly (par. 128). Furthermore, the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art (In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Claims 7, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Copp-Howland/Clark/Parent, as applied to Claim 1, and further in view of US 4490005 by Hovey (cited previously).
Regarding Claims 7, 15 and 16, Copp-Howland as modified in Claim 1 teaches the electrode assembly of claim 1, yet does not explicitly disclose wherein the first electrode is supported by and positioned within the pledget substrate with at least one spacer that allows for the pledget substrate to rotate about the first electrode, the first electrode is supported by and positioned within the pledget substrate with at least one spacer, wherein each spacer includes a retaining structure. However, Hovey teaches an analogous electrode assembly, wherein the male electrode is rotatably supported within the electrode substrate using a spacer and retainer (1:62-65;2:37-42; Fig. 1-2: electrode 14 rotates within retainer and spacer 16, which includes retaining and spacing elements 22/23/26/28/42, and is within the electrode assembly). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing of the claimed invention to incorporate a male electrode rotatably supported in a receptacle of the electrode assembly that includes retainer and spacer elements in a device according to the teachings of Copp-Howland, as taught by Hovey, as this would only amount to an equivalent mechanism of predictably connecting the electrode to the lead, it would permit movement of the patient and/or the relevant equipment without damage to the skin or disconnection of the electrode, and as Hovey suggests the modification would minimize any abrasive effects on the conductive portions of the electrode (1:62-65).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Copp-Howland/Clark/Parent, as applied to Claim 1, and further in view of US 20060258973 by Volt (cited previously).
Regarding Claim 11-12, Copp-Howland as modified in Claim 1 teaches the electrode assembly of claim 1, yet does not explicitly teach that the pledget substrate includes an array of micro needles. However, Volt teaches an analogous electrode assembly including hydrogel layers, which comprises microneedle electrodes (par. 34, 41, 51, 58; Fig. 3: microneedles 10). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an array of microneedles in a device according to the teachings of Copp-Howland, as taught by Volt, in order to bypass the stratum corneum and its effects in the delivery and receipt of electrical signals, and/or this could be used to deliver drugs to the skin as is suggested by Volt (e.g. par. 58).
Claims 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Copp-Howland/Clark/Parent, as applied to Claim 1, and further in view of US 4327737 by Szpur (cited previously).
Regarding Claims 17 and 19-20, Copp-Howland as modified in Claim 1 teaches the electrode assembly of Claim 1, yet does not explicitly disclose, wherein the pledget substrate includes a plurality of perforations, further comprising a second electrode, wherein the pledget substrate includes first and second bodies in contact with each other, wherein the first electrode is positioned within the first body and the second electrode is positioned within the second body; further wherein the first and second bodies are configured to be separable. However, it is well known in the art to mass produce electrodes in long strips that are separable by perforations, and one such example is taught by Szpur (3:40-67 and Fig. 4: electrode strip that is separable via perforations 55). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to produce electrodes according to the teachings of Copp-Howland in the form of long strips separable via perforations, as taught by Szpur, in order to significantly simplify the manufacturing of electrodes in high volume (3: 57-60).
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a non-statutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13, and 15-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,672,487 in view of US 4441501 to Parent.
Regarding Claim 1, Claim 1 of 11,672,487 discloses an intraoperative electrode assembly (Claim 1: An intraoperative electrode assembly) comprising:
a pledget substrate having a first surface that is hydrophilic (Claim 1: a pledget substrate having a first surface that is hydrophilic);
a first electrode supported by and extending through the pledget substrate, the first electrode having a top defining first and second channels (Claim 1: a first electrode supported by and positioned within the pledget substrate; Claim 1: the first electrode including a top having first and second channels); and
a lead wire assembly interconnected to the first electrode, wherein the lead wire assembly is received in the first channel, extends out of the top, and then into the second channel (Claim 1: a lead wire assembly interconnected to the first electrode; Claim 1: wherein the lead wire assembly is received in the first channel, extends out of the top and then into the second channel).
Claim 1 of said issued patent does not disclose the electrode having a base extending from a first side of the pledget substrate, the top opposite the base extending from a second side of the pledget substrate, the first side being opposite the second side.
However, Parent teaches an analogous electrode which extends throughout both a supportive layer and a gel pad, its top extending above these layers and its base extending below these layers (e.g. abstract: “eyelet of a snap fastener conductor extends both through an adhesively coated supporting sheet and a gel pad”, 3:59—4:11, Fig. 1: base flange 30 extends below gel pad 22 and top 32/24 extends above the gel pad 22 and support layer 18). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a base flange that extends from the bottom side of the substrate of an electrode and a top extending from the opposite side of the substrate according to the teachings of Claim 1 of said issued patent, as taught by Parent, as this would only amount to an equivalent mechanism to predictably secure the eyelet electrode to the substrate and the lead wire, and do so as to ensure that the hydrophilic substrate does not fall off from the rest of the electrode, as suggested by Parent (2:10-18).
Regarding Claim 2, Claim 2 of 11,672,487 as modified in Claim 1 (Claim 2 depends on Claim 1), discloses the electrode assembly of claim 1, wherein the lead wire assembly includes at an insulating jacket positioned around a wire core; the first electrode further including an insulating cup interconnecting the first electrode and the insulating jacket (Claim 2: wherein the lead wire assembly includes an insulating jacket positioned around a wire core; the first electrode further including an insulating cup interconnecting the first electrode and the insulating jacket).
Regarding Claim 3, Claim 3 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 2 (Claim 3 depends on Claim 2), wherein the insulating cup is configured to rotate about the pledget substrate (Claim 3: the insulating cup is configured to rotate about the pledget substrate).
Regarding Claim 4, Claim 4 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 4 depends on Claim 1), wherein the pledget substrate is a rayon/polyethylene terephthalate blend (Claim 4: the pledget substrate is a rayon and polyethylene terephthalate blend).
Regarding Claim 5, Claim 5 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 5 depends on Claim 1), wherein the material is further a lint free material (Claim 5: a material of the pledget substrate is a lint free material).
Regarding Claim 6, Claim 6 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 6 depends in Claim 1), wherein the material is further a porous material (Claim 7: the material is further a porous material).
Regarding Claim 7, Claim 7 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 7 depends on Claim 1), wherein the first electrode is supported by and positioned within the pledget substrate with at least one spacer that allows for the pledget substrate to rotate about the first electrode (Claim 7: the first electrode is supported by and positioned within the pledget substrate with at least one spacer that allows for the pledget substrate to rotate about the first electrode).
Regarding Claim 8, Claim 8 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 8 depends on Claim 1), wherein the pledget substrate includes a coating (Claim 8: the pledget substrate includes a coating).
Regarding Claim 9, Claim 9 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 8 (Claim 9 depends on Claim 8), wherein the coating includes a binder, water and surfactant (Claim 9: wherein the coating includes a binder, water and surfactant).
Regarding Claim 10, Claim 10 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 10 depends on Claim 1), further comprising a connector configured to be connected to a nerve monitoring system (Claim 10: a connector configured to be connected to a nerve monitoring system).
Regarding Claim 11, Claim 11 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 10 depends on Claim 1), wherein the pledget substrate includes one or more of mirco hooks or micro needles (Claim 11: the pledget substrate includes one or more of mirco hooks or micro needles).
Regarding Claim 12, Claim 12 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 11 (Claim 12 depends on Claim 11), wherein the pledget substrate includes an array of micro needles (Claim 12: the pledget substrate includes an array of micro needles).
Regarding Claim 13, Claim 13 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 13 depends on Claim 1), wherein a first side of the pledget substrate includes a hydrophilic first coating and a second side of the pledget substrate includes a hydrophobic coating (Claim 13: a first side of the pledget substrate includes a hydrophilic first coating and a second side of the pledget substrate includes a hydrophobic coating).
Regarding Claim 15, Claim 14 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 14 depends on Claim 1), wherein the first electrode is supported by and positioned within the pledget substrate with at least one spacer (Claim 14: the first electrode is supported by and positioned within the pledget substrate with at least one spacer).
Regarding Claim 16, Claim 15 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 15 (Claim 15 depends on Claim 14), wherein each spacer includes a retaining structure (Claim 15: each spacer includes a retaining structure).
Regarding Claim 17, Claim 16 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 16 depends on Claim 1), wherein the pledget substrate includes a plurality of perforations (Claim 16: the pledget substrate includes a plurality of perforations).
Regarding Claim 18, Claim 17 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 17 depends on Claim 1), wherein the first electrode includes a top, a base and an axle interconnecting the top and base (Claim 17: the first electrode includes a top, a base and an axle interconnecting the top and base).
Regarding Claim 19, Claim 18 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 1 (Claim 18 depends on Claim 1), further comprising a second electrode (Claim 18: a second electrode).
Regarding Claim 20, Claim 19 of 11,672,487 as modified in Claim 1 discloses the electrode assembly of claim 19 (Claim 19 depends on Claim 18), wherein the pledget substrate includes first and second bodies in contact with each other, wherein the first electrode is positioned within the first body and the second electrode is positioned within the second body; further wherein the first and second bodies are configured to be separable (Claim 19: the pledget substrate includes first and second bodies in contact with each other, wherein the first electrode is positioned within the first body and the second electrode is positioned within the second body; further wherein the first and second bodies are configured to be separable).
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 MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571)272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
MANOLIS PAHAKIS /M.P./
Examiner
Art Unit 3792