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 . Claims 1-19 are currently pending with claim 19 being withdrawn (see below).
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-18, drawn to the electrode and array, classified in A61B5/266.
II. Claim 19, drawn to the method of making the electrode array, classified in H01B13/00.
The inventions are independent or distinct, each from the other because:
Inventions of Group I and Group II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the apparatus of claim 1 can be made by a materially different process such as simply crimping or adhering the lead wire into the lead connector in lieu of melting it.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art in view of their different classification;
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
During a telephone conversation with Mark Stephenson on 09/02/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-18. Affirmation of this election must be made by applicant in replying to this Office action. Claim 19 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 13, 18 are objected to because of the following informalities: both include that the electrodes are “MR conditional”, where the abbreviation for “MR” needs to be spelled out the first time it’s used in the claims to avoid ambiguity or confusion. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 17 recites that the lead wire connector is 30-50 cm however the Applicant mentions that the lead wire is 30-50cm (0020]), not the connector.
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.
Claims 1-2, 4, 6, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishiwaki et al. US Publication 2018/0028089 (hereinafter Nishiwaki).
Regarding claim 1, Nishiwaki discloses a medical electrode (Figure 3), comprising: an electrode body (Figures 3, 8) including: a skin side and an outer side opposite the skin side (Figures 3, 8 where the outer side is near 2, 8 in the Figures and the opposing side near 7 is the skin contacting side, see also Figure 11); a dome comprising a central cavity and having a height (Figures 3, 5-8 at dome 3 with the central cavity including a gel 7), the central cavity comprising a central cavity area (Figures 3, 5, 8 near 7) and at least one protrusion extending only within the central cavity (elements 4in Figure 8); and a rim surrounding the central cavity (5) and having a thickness smaller than the height (5 as per Figures 3, 5, 8), the rim having a skin contact area (the tip of 5 is fully capable of contacting skin); and a lead wire connector extending outwardly from the body (8), wherein each of the central cavity area and the skin contact area of the rim are electrically conductive and are located on the skin side (the elements 3-5 can all be made of conductive material Ag/AgCl or carbon resin, see [0042]-[0043]).
Regarding claim 2, Nishiwaki discloses that the at least one protrusion comprises a rib (elements 4) arranged within +/- 10 degrees of a radial direction relatively to a central axis through the central cavity (Figure 8 which shows little to no angular change from the central axis direction).
Regarding claim 4, Nishiwaki discloses that the ribs are evenly distributed within
the central area (Figures 2, 4, 9 which shows that they are evenly distributed in each design).
Regarding claim 6, Nishiwaki discloses that the dome has the shape of a truncated cone with rounded edges (Figure 7A).
Regarding claim 11, Nishiwaki discloses that the body comprises a polymer-based core material with a conductive surface coating of Ag/AgCl (electrode body, which includes the protrusions includes PET coated with Ag/AgCl as per [0061]).
Regarding claim 12, Nishiwaki discloses that the cavity is prefilled with a conductive gel (7).
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.
The factual inquiries 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 non-obviousness.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Nishiwaki.
Regarding claim 3, Nishiwaki discloses that the at least one protrusion comprises ribs (Figures 3, 5, 8 which shows six ribs at element 4), each of the ribs arranged within +/- 10 degrees of a radial direction relatively to a central axis through the central cavity (Figure 8 which shows little to no angular change from the central axis direction). Nishiwaki discloses 6 ribs and does not disclose between 3-5. The Applicant, however, includes no criticality as to the number required, but also mentions that it could be higher such as 10 or a larger range of 2-8 ([0058]). Therefore, it would have been obvious to the skilled artisan before the effective filing date to optimize the number of ribs of Nishiwaki as a matter of design choice.
Regarding claim 5, Nishiwaki discloses that each of the ribs comprises a rib area (elements 4, Figures 3, 5, 8), but is silent on the total electrode area. Given the lack of criticality for the claimed range, and that Nishiwaki is in the exact same field of endeavor (gel providing EEG electrodes for scalp contact), it would have been obvious to the skilled artisan before the effective filing date to include an electrode area to the range of 95 to 130 mm² as a matter of routine optimization. See MPEP 2144.04-IIA, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Nishiwaki in view of Wandler US Publication 2015/0327788 (hereinafter Wandler).
Regarding claims 7-8, Nishiwaki details the lead connector above, but is silent on any of the claimed structural detail. Wandler teaches an electrode connector that includes a depression (the depression being the channel shown in Figures 3-4) and at least one wall adjacent to the depression (any of the walls around 14, 16; in the alternate the depression can also include the change in angle at 19), where the depression is sectioned by a step providing a shallow conducting portion and a deep connection portion (Figures 3-4 which shows the two portions 14, 16, where the two are different sizes and protrude at different dimensions which is being considered stepped, there is also a visible change between eh two at 12 in Figure 3), the deep connection portion being outward of the shallow conducting portion (Figures 3-4 which shows the two portions 14, 16). It would have been obvious to the skilled artisan before the effective filing date to utilize the connector type as taught by Wandler with the device of Nishiwaki as predictable results would have ensued (utilizing a known wire connection type in lieu of another known connection type).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nishiwaki in view of Lang et al. US Publication 2013/0141093 (hereinafter Lang).
Regarding claim 9, Nishiwaki discloses that the skin contact area of the rim
comprises an outer periphery (5), but is silent on the cutouts. Lang teaches an MR
imaging electrode that further comprises cut-outs extending inwardly from the outer periphery of the rim (claim 5). It would have been obvious to the skilled artisan before the effective filing date to utilize the cutouts as taught by Lang with the device of Nishiwaki in order to aid in reducing eddy currents ([0024] of Lang).
Regarding claim 10, Nishiwaki is silent on the cutouts. Lang teaches said cutouts (above), but discloses a higher number and include a larger radial depth. Lang recognizes the competing effects governing how many interruptions to use and how far they extend: eddy current is reduced in proportion to the square of the surface area of each portion defined between the slits, while the slits are kept narrow and remove little of the total area so as to avoid reducing current transfer to the skin. Lang gives general values of 8-12 slots at 1-2 mm width with 10-15 mm spacing, and states that the number, width and spacing can be varied.
Cut-out count and radial depth are therefore result-effective variables, recognized as trading artifact suppression against conductive contact area. Three to five cut-outs of 0.5–1.5 mm radial depth on a 10 mm electrode is the ordinary consequence of applying Lang's design rule to an electrode an order of magnitude smaller than the patches Lang exemplifies. Applicant's specification confirms the scaling is expected: it states that eddy-current and artifact risk increases with diameter and that the benefit of the cut-outs is more pronounced for larger electrodes, and it defines depth as a proportion, 5-15% of the outer diameter of the peripheral skin contact area, rather than an independently significant dimension. Applicant's stated upper bound (of 5) does not establish criticality. The specification only states that more than five cut-outs is generally not recommended because the active area is considered to be reduced too much, and provision of further cut-outs complicates molding. That is a recognition that the variable affects the result, the predicate for optimization under In re Antonie, coupled with a manufacturing-convenience rationale. No comparative data is presented, no discontinuity at either endpoint is identified, and the specification elsewhere states a single cut-out could in some cases be enough. Absent evidence of criticality commensurate with the claimed scope, the range is prima facie obvious.
Claims 13-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nishiwaki in view of Iversen et al. US Patent 8,682,409 (hereinafter Iversen).
Regarding claim 13, Nishiwaki discloses that the bottom portion, barb members and annular wall may be formed of conductive carbon resin with the electrode metal omitted entirely, the bottom portion and connection member being integrated and themselves functioning as the electrode ([0042]-[0045]; Figure 5), and that the barb members may be polyethylene terephthalate coated with silver or silver/silver chloride powder ([0061]), but is silent on the entire electrode (lead connector included) being MR conditional.
Iversen teaches MR conditional surface electrodes for long-term EEG sensing, constructed of non-magnetic materials (column 3 lines 8-29 as well as claims 2, 5). Therefore, it would have been obvious to the skilled artisan before the effective filing date to construct Nishiwaki's metal-free conductive-polymer electrode of the non-magnetic materials taught by Iversen, in order to allow the overall device to be MR compatible (a desirable quality for long-term monitoring devices, which includes the added bonus of not having to spend time repositioning the electrodes on/off the patient as detailed by Iversen)
Regarding claim 14, Nishiwaki discloses a plurality of the medical electrodes (the electrodes of claim 1, see above) placed at positions ([0038], [0068]-[0070]; Figures 11-12); each lead wire connector being electrically conductive, the connection member 8 being configured by a conductive material such as carbon ([0063]) and integrated with the conductive bottom portion ([0045]); and a lead wire having a first end at the connection member and a second end connected to the recording apparatus, a cord being connected to the connection member at one end and to the electrocardiograph at the other ([0038], [0070]), but is silent on the insulating cladding.
Iversen teaches an insulated flexible lead wire structure extending from each of a plurality of electrode body structures and terminating in a plug for connection to an EEG assembly (claims 1, 5, see also columns 3-4), and teaches that the lead wire is bonded to the surface electrode disc or cone using conductive epoxy, welding, crimping, soldering, insert molded in place, or other known means (column 3 lines 51-63). It would have been obvious to the skilled artisan before the effective filing date to provide Nishiwaki's plurality of headband-mounted electrodes with Iversen's pre-attached insulated lead wires terminating in a common connector, in order to obtain Iversen's stated benefit of disconnecting and reconnecting an entire electrode set quickly and accurately.
Regarding claim 15, Nishiwaki is silent on the lead wire material choice. Iversen teaches that the signal-carrying wire is constructed of a non-magnetic material (claims 4, 7). It would have been obvious to the skilled artisan before the effective filing date to utilize the conductive non-magnetic conductor for the lead wires as aught by Iverson with the array of Nishiwaki in order to avoid the displacement forces, heating and image artifacts associated with magnetic materials in the imaging environment.
Regarding claim 16, Nishiwaki discloses the lead wire connector as a connection member configured by a conductive material, for example carbon ([0063]), integrated with a bottom portion formed of conductive carbon resin, in a configuration in which the electrode metal is absent altogether ([0042], [0045]; Figure 5), but is silent on the lead wire connector materials. Iversen teaches that all of the electrode structures contain no magnetic metal (claims 2, 4, 7, 11, and 13 as well as column 3 lines19-23, 59-63 and column 4 lines 16-18). It would have been obvious to the skilled artisan before the effective filing date to utilize the material choices for the electrode device as taught by Iverson with the device of Nishiwaki's in order to make the device MR safe given the long-term use as is known in the art and detailed across Iverson’s disclosure.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nishiwaki in view of Iversen, as applied to claim 14, and in further view of Ives et al. US Publication 2010/0059274 (hereinafter Ives).
Regarding claim 17, Nishiwaki is silent on the lead wire (based on the 112 above, it’s the wire not the connector at the claimed length). Ives teaches an EEG monitoring device that is MR conditional that includes a lead wire with a length in the interval of 30 to 50 cm ([0066]). It would have been obvious to the skilled artisan before the effective filing date to utilize the length of lead wire as taught by Ives with the device of Nishiwaki and Iversen in order to allow the user greater degrees of movement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/ Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/ Supervisory Patent Examiner, Art Unit 3794
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