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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 21, 24, 26-28, 36-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erb (US Patent No 20140142410).
Regarding claim 21, Erb teaches an intraoperative electrode assembly (electrode assembly 100, [0031]), comprising: a pledget substrate (see substrate body 102, [0031]) including first and second bodies coupled to one another at a joining region (see from the fig 1 in which the top side of the electrode assembly is considered the analogous first body and the bottom side is considered the analogous second body, in which the substrate body portion 102 found in between is equated to the joining region), the pledget substrate having a first side configured for placement on tissue (see from fig 1, the bottom view of the electrode assembly 100 configured for placement on the skin, [0032]); a plurality of electrodes positioned on the pledget substrate (electrodes 104 and 106 configured on the substrate 102, [0031]), each of the first and second bodies supporting at least one electrode of the plurality of electrodes (see in which the first body supports electrode 104 and the second body supports electrode 106, see fig 1); and a lead wire assembly electrically coupled to the plurality of electrodes (see lead wires 110, [0031]), wherein the joining region is configured to be separable to allow the first and second bodies to be independently positioned on the tissue (see from the fig 9, in which the electrode assemblies are separable into multiple electrode sets that may be configured to be placed independently on the body, [0053]).
Regarding claim 24, Erb teaches the electrode assembly according to claim 21, wherein each of the first and second bodies is generally circular or oblong in shape (see from the fig 2, in which the assemblies have rounded edges and are oblong in shape).
Regarding claim 26, Erb teaches the electrode assembly according to claim 21, wherein the pledget substrate is formed from a blend of rayon and polyethylene terephthalate (see in which the substrate may be formed of a variety of polymers including polyethylene combinations, [0034]).
Regarding claim 27, Erb teaches the electrode assembly according to claim 21, wherein at least one electrode of the plurality of electrodes is an evoked potential monitoring electrode (see in which the assembly contains stimulating electrodes for use in evoked potential monitoring in electrophysiological procedures, [0030]).
Regarding claim 28, Erb teaches the electrode assembly according to claim 21, wherein the pledget substrate is configured to affix to tissue under wet conditions via surface tension or bioadhesion (see from Erb, in which a wet gel or wet condition adhesive may be used to adhere the assembly to the skin, [0034]).
Regarding claim 36, Erb teaches an electrode assembly for interfacing with tissue during an intraoperative procedure (electrode assembly 100, [0031]), comprising: a pledget substrate (see substrate body 102, [0031]) including a plurality of separable bodies (see from the fig 1 in which the top side of the electrode assembly is considered the analogous first body and the bottom side is considered the analogous second body, in which the substrate body portion 102 found in between is equated to the joining region, see also from fig 9 in which the assembly may be separable); and a plurality of electrodes supported by the pledget substrate , wherein each of the separable bodies supports at least one electrode of the plurality of electrodes (see in which the first body supports electrode 104 and the second body supports electrode 106, see fig 1) and is configured for contact with tissue to enable at least one of stimulation of the tissue during the intraoperative procedure or recording of bioelectric signals generated by the tissue in response to stimulation during the intraoperative procedure (see in which the assembly contains stimulating electrodes for use in evoked potential monitoring in electrophysiological procedures, [0030]).
Regarding claim 37, Erb teaches the electrode assembly according to claim 36, wherein the pledget substrate is configured to be applied directly to a surface of thyroid cartilage of a patient (see from [0016], in which the electrode placements are made in order to maintain nerve contact, and furthermore some example placements for the electrode assemblies may be in the head or neck area and therefore the electrode assemblies 100 are capable of being placed in the thyroid of a patient).
Regarding claim 38, Erb teaches the electrode assembly according to claim 36, wherein the pledget substrate includes microhooks or microneedles for securing the pledget substrate to the tissue (see the small hooking feature 109 found on the substrate member 102 in Erb fig 3).
Regarding claim 39, Erb teaches the electrode assembly according to claim 36, wherein the pledget substrate includes a joining region configured to be separable to allow the plurality of separable bodies to be independently positioned on the tissue (see from the fig 1 in which the top side of the electrode assembly is considered the analogous first body and the bottom side is considered the analogous second body, in which the substrate body portion 102 found in between is equated to the joining region, see also from fig 9 in which the assembly may be separable).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 22-23, 29-33, 35, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erb (US Patent No 20140142410) in view of McIntire (US Patent No 20100075549).
Regarding claim 22, Erb teaches the electrode assembly according to claim 21.
Erb does not teach wherein the joining region includes perforations to assist in separation of the first and second bodies.
However, the analogous electrode lead assembly disclosed by McIntire does teach the joining region includes perforations to assist in separation of the first and second bodies (see from McIntire fig 1, in which the electrode bodies 20 are joined together by a base joining region 25 and includes a separable interface 27 in-between which may take the form of a perforated edge, [0019]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode assembly with different body regions taught by Erb, to contain separable interfaces containing perforated sections in between the electrode bodies as taught by McIntire, as it is a known structure in the art to allow for easy separation and allow for more conformability of the electrode body and placement as taught by McIntire, [0019].
Regarding claim 23, the combination teaches the electrode assembly according to claim 21, wherein the joining region has a reduced thickness relative to the first and second bodies to assist in separation of the first and second bodies (see from McIntire fig 1, in which the electrode bodies 20 are joined together by a base joining region 25 of relatively lower thickness and includes a separable interface 27 in-between which may take the form of a perforated edge, [0019]).
Regarding claim 29, Erb teaches an electrode assembly (electrode assembly 100, [0031]), comprising: a pledget substrate (see substrate body 102, [0031]) including a first body and a second body joined at a separable region (see from the fig 1 in which the top side of the electrode assembly is considered the analogous first body and the bottom side is considered the analogous second body, in which the substrate body portion 102 found in between is equated to the joining region, see also from fig 9 in which the assembly may be separable); a first electrode supported on the first body; a second electrode supported on the second body (see in which the first body supports electrode 104 and the second body supports electrode 106, see fig 1); and a respective lead wire connected to each of the first and second electrodes (see lead wires 110, [0031]).
Erb does not teach wherein the joining region includes perforations to assist in separation of the first and second bodies.
However, the analogous electrode lead assembly disclosed by McIntire does teach the joining region includes perforations to assist in separation of the first and second bodies (see from McIntire fig 1, in which the electrode bodies 20 are joined together by a base joining region 25 and includes a separable interface 27 in-between which may take the form of a perforated edge, [0019]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode assembly with different body regions taught by Erb, to contain separable interfaces containing perforated sections in between the electrode bodies as taught by McIntire, as it is a known structure in the art to allow for easy separation and allow for more conformability of the electrode body and placement as taught by McIntire, [0019].
Regarding claim 30, Erb teaches the electrode assembly according to claim 29, wherein the first and second electrodes are positioned such that, when separated, each of the first and second bodies of the pledget substrate maintains nerve contact during laryngeal monitoring (see from [0016], in which the electrode placements are made in order to maintain nerve contact, and furthermore some example placements for the electrode assemblies may be in the head or neck area and therefore the electrode assemblies 100 are capable of being placed in the larynx).
Regarding claims 31 and 32, the combination of Erb and McIntire does not explicitly teach wherein the pledget substrate includes coloring to indicate a tissue-contacting side of the pledget substrate and a second color to indicate the secondary side.
However, the prior art of Erb does disclose that the electrode assembly may have a large label 204 disposed of on the entire second surface of the electrode assembly, in which the label is there to provide instructions as well as to indicate that the opposite side is the primary skin contacting side, [0032]. Therefore, as Erb does disclose a label which covers and indicates the presence of the secondary side and the primary contact side, it would have been obvious for one skilled in the art to take that teaching of Erb and color-coat the primary and secondary sides with the provided label as to indicate with side is the skin-contact side. Therefore, containing enough disclosure to teach the limitation as presently claimed.
Regarding claim 33, Erb teaches the electrode assembly according to claim 29, wherein the pledget substrate includes apertures for receiving sutures or staples (see in which the substrate 102 may have an opening which is capable of receiving sutures or staples, [0039]).
Regarding claim 35, Erb teaches the electrode assembly according to claim 29, wherein at least one of the first or second electrodes is an evoked potential monitoring electrode (see in which the assembly contains stimulating electrodes for use in evoked potential monitoring in electrophysiological procedures, [0030]).
Regarding claim 40, the combination teaches the electrode assembly according to claim 39, wherein the joining region includes one of perforations or a reduced thickness relative to the plurality of separable bodies (see from McIntire fig 1, in which the electrode bodies 20 are joined together by a base joining region 25 of relatively lower thickness and includes a separable interface 27 in-between which may take the form of a perforated edge, [0019]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erb (US Patent No 20140142410) in view of Takaki (US Patent No 20030088239).
Regarding claim 25, Erb teaches the electrode assembly according to claim 2.
Erb does not teach wherein the pledget substrate is hydrophilic on the first side and hydrophobic on the second side opposite to the first side.
However, the analogous conductive and adhesive electrode assembly structure taught by Takaki does disclose the pledget substrate is hydrophilic on the first side and hydrophobic on a second side opposite to the first side (see in which there is a multi-layer electrode structure which contain multiple phases including a first formed hydrophilic phase on the first side followed by a hydrophobic adhesive polymer formed on a secondary side of the structure, [0052]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode assembly configuration taught by Erb to contain the hydrophilic and hydrophobic sides to the electrode structure as taught by Takaki, as it is a known method in the art to increase signal conductance on an electrode body, as taught by Takaki, [0052].
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erb (US Patent No 20140142410) in view of McIntire (US Patent No 20100075549) further in view of Takaki (US Patent No 20030088239).
Regarding claim 34, the combination of Erb and McIntire teaches the electrode assembly according to claim 29.
Erb and McIntire do not teach wherein the pledget substrate is hydrophilic on the first side and hydrophobic on a second side opposite to the first side.
However, the analogous conductive and adhesive electrode assembly structure taught by Takaki does disclose the pledget substrate is hydrophilic on the first side and hydrophobic on a second side opposite to the first side (see in which there is a multi-layer electrode structure which contain multiple phases including a first formed hydrophilic phase on the first side followed by a hydrophobic adhesive polymer formed on a secondary side of the structure, [0052]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode assembly configuration taught by Erb and McIntire to contain the hydrophilic and hydrophobic sides to the electrode structure as taught by Takaki, as it is a known method in the art to increase signal conductance on an electrode body, as taught by Takaki, [0052].
Conclusion
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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