The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Invention I, and Species B and (i) in the reply filed on March 23, 2026 and April 29, 2026 is acknowledged. The following claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions and/or species:
Claims 11-17 are withdrawn as being part of non-elected Invention II;
Claims 3-4 are withdrawn as being part of non-elected Species A;
Claim 5 is withdrawn as being part of non-elected Species C;
Claims 18-20 are withdrawn as being part of non-elected Species (ii).
Currently, there is no allowable generic or linking claim.
Based on the above, claims 1-2 and 6-10 are pending.
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 1-2 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mar et al. (US Patent No. 5,439,485) in view of De Kock et al. (US Patent Pub. No. 2017/0319864).
Mar discloses a flexible defibrillation electrode with an improved construction (see Title). Specifically, Mar teaches a shocking electrode (i.e., for defibrillation as indicated in the title) of a lead for an implantable medical device (IMD) (i.e., Mar teaches “an implantable defibrillator lead comprises a flexible core onto which is wound helically wound coils to form an electrode” – see Abstract)) the shocking electrode comprising:
A coiled conductor (see electrode 20 in Figure 1, provided with further detail as coils 24 in Figure 2) that … is configured to deliver high-voltage shocks for defibrillation therapy (see Abstract, which defines this as being an implantable defibrillator lead having an electrode), wherein the coiled conductor includes an electrically conductive element that is helically wrapped (see column 3, lines 63-66; “FIG. 2 shows a detail view of the distal connection of the lead 18 of FIG. 1. Electrode 20 is shown to be constructed of many (six) electrode coils 24 helically wound around a flexible tubular supporting core 22”) …, wherein the electrically conductive element is… (ii) a micro-coil that includes a coiled strand (see Figure 10, illustrating the device of Mar within the heart of a patient; see Figures 1-2 illustrating closer views of the same device, from which it is evident that the coils 24 are micro-sized and include coiled strands) … .
However, it is noted that Mar is deficient with respect to “a coiled conductor that has an oblong cross-sectional shape” and “wherein the coiled conductor includes an electrically conducive element that is helically wrapped and defines the oblong cross-sectional shape”.
De Kock teaches “A subcutaneous implantable cardioverter-defibrillator (S-ICD) comprising shocking electrodes” (see Abstract). As taught, “The shocking coil electrode 308 may have a generally flattened cross-sectional configuration… For example, referring to FIGS. 3B and 3C which illustrate an end view and a perspective view, respectively, of the illustrative coil electrode 308, the coil electrode 308 may have a cross-sectional shape that generally takes the form of an oval. The cross-sectional shape may have two curved ends and two parallel sides connecting the curved ends” (see paragraph 45). “The coil electrode 308 may have a larger surface area and/or shadow than a typical shocking coil electrode. It is contemplated that increasing the surface area and/or shadow of the shocking electrode 308 may allow the defibrillation threshold to be lowered” (see paragraph 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a flattened shape for a shocking/defibrillating electrode, as taught by De Kock, and to provide this shape in the system and methods of Mar, because “Some electrodes have a width or surface area that is larger than typical shocking electrodes. The increased surface area or shadow may reduce the defibrillation threshold” (see paragraph 4 of De Kock).
Regarding claim 2, it can be seen in Figure 2 of Mar that the coils 24 have micro-turns and macro-turns. That is, each coil is helically wound around the core 22 (i.e., macro-turns) and each coil itself has a plurality of small spirals making up the coil. By the combination with De Kock, it would be obvious to have an overall shape that has a generally flattened cross-sectional configuration for the core.
Regarding claim 6, it is re-iterated that the device of Mar comprises a core 22, which is equivalent to the claimed base structure, along with elastomeric material 28. Additionally, by the combination with De Kock, it would be obvious that this has an overall shape that has a generally flattened cross-sectional configuration.
Regarding claim 7, it can be seen in Figure 2 and Figure 4b that the coils is embedded within the elastomeric material 28 that creates the outer surface of the base structure.
Regarding claim 8, it can be seen in Figure 4b that the coils 24 are embedded within the elastomeric material 28 such that they reside within grooves that allow the coils 24 to be partially embedded and partially exposed.
Regarding claim 9, it is noted that Mar teaches that “This structure has elastomeric material 28, which also may be … insulative, partially encapsulating the electrode coils” (see column 4, lines 1-2).
Regarding claim 10, it is re-iterated that Mar teaches via Figure 4b that the coils 24 are embedded within the elastomeric material 28 such that they reside within grooves that allow the coils 24 to be partially embedded and partially exposed. Mar teaches that “One method of achieving this structure is to completely encapsulate the wrapped electrode coils, then abrade away the surface to partially expose the coils” (see column 4, lines 4-7), which clearly teaches to overmold the entire core 22 and coils 24, then removing some of the overmolded elastomeric material 28 away to expose a portion of the coils. Additionally, it is re-iterated that by the combination with De Kock, it would be obvious that this overall structure has an overall shape that has a generally flattened cross-sectional configuration.
Conclusion
Additional prior art is made of record as being considered pertinent to applicant's disclosure, but not relied upon in the rejections above, and can be found on the accompanying PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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