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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-13) in the reply filed on 3/24/2026 is acknowledged. The traversal is on the grounds that Raje fails to teach the windings over a core. This is not found persuasive because the technical feature that is not special a helical wire structure comprising one or more strands wound about a hollow core. The core is not part of the claimed invention and the technical feature is just a helical wire structure comprising one or more strands wound about a hollow region which is interpreted as a core. Raje teaches the helical conductor winding (e.g. 2602 Fig. 12) enclosing a hollow core which is the hollow spacing in the helical coil.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/24/2026.
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.
Claims 1-13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, “a hollow core” is inferentially included and not positively recited while claim 4 further recites limitations regarding how the hollow core is being utilized. Therefore, it is unclear as to whether the hollow core is actually part of the claimed invention or not.
The claim as recited is directed to a device that comprises a flexible helical wire structure comprising wire rope comprising a plurality of strands of biocompatible conductive wire. As recited “said helical wire structure … and being configured for loading into a dispenser capable of creating an insertion channel to the tissue target, and at least a portion of said helical wire structure being capable of self-forming a bunching anchor wider than said insertion channel when injected while said dispenser is substantially stationary, so that said bunching anchor is capable of self-anchoring said the injectable electrode in place” is intended use. The claim is directed to a device and not a method and so it is unclear as to what structural elements are being claimed as part of the claimed invention.
In claim 1, it is unclear as to what is meant by “substantially stationary”. While applicant’s originally filed specifications do provide a special definition for “substantially linear” in terms of the helical wire structure as being either straight, somewhat wavy or gently meandering, but not a sharp bend, corner or a bunching. (e.g. [0094]), the term substantial in this context renders the claim unclear since the originally filed specifications do not provide any special definition for the term “substantially” or any standard for ascertaining the requisite degree. Therefore, it is unclear as to what is meant by said dispenser is substantially stationary.
Claims 2 and 3 are recited as intended use claims and therefore it is unclear as to what structural limitations are being claimed.
In claim 4, the “guide wire” is inferentially included and it is unclear of the guidewire is part of the claimed invention or not.
Claim 5 recites a “conventional” lead wire. it is unclear as to what is meant by “conventional”.
Claim 1 states that the wire rope comprises a plurality of strands and 13 states that the wire rope comprises a single strand. This recitation makes claim 1 and 13 unclear.
The dependent claims inherit the deficiencies.
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.
Claims 1-4 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kuzma et al (U.S. Patent Application Publication Number: US 2003/0114905 A1, hereinafter “Kuzma”) in view of Franz et al (U.S. Patent Application Publication Number: US 2007/0282411 A1, hereinafter “Franz”).
Regarding claim 1 (as best understood), Kuzma teaches an injectable electrode, comprising:
a helical wire structure (e.g. [0029], Fig.2B shows a removable flexible lead 12 comprising at least two helically wound conductors) configured for full and chronic implantation on or near a tissue target in a body for conduction of energy to or from said tissue target (e.g. [0002]: implantable microminiature sensor or microsensor), said helical wire structure comprising:
at least one wire rope comprising a plurality of strands of biocompatible and conductive wire (e.g. Fig.2B shows a lead 12 with at least two helically wound conductors), said helical wire structure enclosing a hollow core within an inner diameter and having a longitudinal axis (the helical winding forms a hollow core with an inner diameter formed by the inner diameter of the winding and an outer diameter formed by the winding and a proximal and distal end), an outer diameter and two ends,
said helical wire structure having flexibility for self-bending (e.g. Fig.1 shows that the flexible lead 12 is capable of bending) in any direction up to 180 degrees on said longitudinal axis, and being configured for loading into a dispenser (e.g. 14 Fig.2: hypodermic needle) capable of creating an insertion channel to the tissue target, and
at least a portion of said helical wire structure (e.g. Fig.2 shows a portion of the wire structure 12 comprising a bunched anchor at the distal end) being capable of self-forming a bunching anchor (e.g. 17b Fig.1B [0035]: bunched anchor) wider than said insertion channel when injected while said dispenser is substantially stationary, so that said bunching anchor is capable of self-anchoring said the injectable electrode in place.
As discussed above, the core is not being positively recited. However, if the core is part of the claimed invention, Kuzma does not specifically teach a hollow core as claimed. Franz teaches a lead (e.g. 200 Fig.2) comprising conductors (e.g. 201 Fig.2) and a hollow core permitting a stiffening stylette to be inserted through the core (e.g. 202 Fig.2, [0035]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Kuzma to include a hollow core as taught by Franz in order to provide the predictable results of allowing for easier insertion during implantation.
Regarding claims 2 and 3, since Kuzma in view of Franz teaches the structural elements of the claimed invention as discussed above, they teach that said helical wire structure is further configured to be formed into a substantially linear portion when exiting from said dispenser when said dispenser is moving and said injectable electrode is further configured for minimally invasive removal so that, when said helical wire structure is pulled from a middle portion or near one of said the two ends, said longitudinal axis lengthens by reducing said inner diameter and said outer diameter as claimed.
Regarding claim 4, since Kuzma in view of Franz teaches the structural elements of the claimed invention as discussed above and they teach a hollow core permitting a stiffening stylette to be inserted through core as discussed above and therefore they said hollow core is at least partially filled by a guide wire prior to and during injection and said guide wire is configured to be withdrawn during or after implantation by a clinician as claimed.
Regarding claim 10, Kuzma in view of Franz teaches the claimed invention as discussed above and Kuzma further teaches at least one mechanical stabilizer or an insulator (Note: the lead body of the electrode lead 12 is insulated and is considered as a mechanical stabilizer or an insulator affixed to the helical wound conductors, the connector 11 can also be considered as a mechanical stabilizer affixed to a portion of the helical wire structure since the claim as recited do not recite any structure for the “mechanical stabilizer”) is affixed to a portion of the helical wire structure.
Regarding claim 11, since Kuzma in view of Franz teaches the structural elements of the claimed invention as discussed above and they teach a hollow core permitting a stiffening stylette to be inserted through core as discussed above and therefore they said hollow core is configured for passage of a substance during injection.
Regarding claim 12, Kuzma in view of Franz teaches the structural elements of the claimed invention as discussed above and Kuzma further teaches that unlike the first electrode anchor 17a which encircles the electrode head 16, the wires of second electrode anchor 17b are bunched together and fold back over the end of the electrode lead as a group (e.g. [0035]) and therefore they teach that said bunching anchor has an irregular shape.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kuzma et al (U.S. Patent Application Publication Number: US 2003/0114905 A1, hereinafter “Kuzma”) in view of Franz et al (U.S. Patent Application Publication Number: US 2007/0282411 A1, hereinafter “Franz”) and further in view of Min (U.S. Patent Application Publication Number: US 2010/00114275 A1, hereinafter “Min”) OR Sommer (U.S. Patent Application Publication Number: US 2007/0250143 A1, hereinafter “Sommer”).
Regarding claim 6, Kuzma in view of Franz teaches the claimed invention as discussed above except for wherein a portion of the plurality of strands have a different diameter or are composed of a different conductive material.
Min teaches a lead comprising multiple strands (i.e. filars) made of different conductive materials (e.g. [0036]). Sommer also teaches a lead comprising multiple strands (i.e. filars) made of different conductive materials ([0019], [0044]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the strands in the teachings of Kuzma in view of Franz to be made of different conductive materials as taught by the teachings of Min OR Sommer in order to provide the predictable results of having a improved system that can be used for different purposes.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kuzma et al (U.S. Patent Application Publication Number: US 2003/0114905 A1, hereinafter “Kuzma”) in view of Franz et al (U.S. Patent Application Publication Number: US 2007/0282411 A1, hereinafter “Franz”) and further in view of Min (U.S. Patent Application Publication Number: US 2010/00114275 A1, hereinafter “Min”).
Regarding claim 7, Kuzma in view of Franz and Min teaches the claimed invention as discussed above except for wherein the different diameter or the different conductive material are concentrated in different portions of the helical wire structure having different bending capabilities.
Min further teaches that the filars may have increasing/decreasing helical coil pitch (e.g. [0036] Figs 2,6,7) and therefore they teach that the different conductive material is concentrated in different portions of the helical wire structure having different bending capabilities. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the coil pitch of the conductive strands in the teachings of Kuzma in view of Franz and Min as taught by Min in order to provide the predictable results of improving MRI safety.
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kuzma et al (U.S. Patent Application Publication Number: US 2003/0114905 A1, hereinafter “Kuzma”) in view of Franz et al (U.S. Patent Application Publication Number: US 2007/0282411 A1, hereinafter “Franz”) and further in view of Bottomley et al (U.S. Patent Application Publication Number: US 2008/02431218 A1, hereinafter “Bottomley”).
Regarding claim 8, Kuzma in view of Franz teaches the claimed invention as discussed above except for said biocompatible and conductive wire is selected from the group consisting of gold, silver, platinum, stainless steel, titanium, titanium-nickel, iridium, platinum-iridium, tungsten, platinum-tungsten, and other metal alloys including MP35N.
In a similar field of endeavor, Bottomley teaches an implantable helical wire structure comprising a wire rope comprising of a plurality of strands of biocompatible conductive wires (e.g. [0114], Fig. 22C, 22F) wherein said biocompatible and conductive wire is selected from the group consisting of gold, silver, platinum, stainless steel, titanium, titanium-nickel, iridium, platinum-iridium, tungsten, platinum-tungsten, and other metal alloys including MP35N (e.g. [0218]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Kuzma in view of Franz to have the conductors comprises of the claimed materials as taught by Bottomley in order to provide the predictable results of improving MRI compatibility.
Regarding claim 13, Kuzma in view of Franz teaches the claimed invention as discussed above except for the at least one wire rope comprises a single strand of continuous length which has been folded and then twisted.
Bottomley teaches that it is well known to configured a wire rope comprising a single strand that ius which has been folded and then twisted (e.g. Fig.21, [0059], [0201]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify wire rope in the teachings of Kuzma in view of Franz to be a single strand of continuous length which has been folded and then twisted as taught by Bottomley in order to provide the predictable results of improving MRI compatibility.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kuzma et al (U.S. Patent Application Publication Number: US 2003/0114905 A1, hereinafter “Kuzma”) in view of Franz et al (U.S. Patent Application Publication Number: US 2007/0282411 A1, hereinafter “Franz”) and further in view of Foster et al (U.S. Patent Application Publication Number: US 2012/0053662 A1, hereinafter “Foster”).
Regarding claim 9, Kuzma in view of Franz teaches the claimed invention as discussed above except for the at least one wire rope further comprises strands of nonconductive material.
In a similar field of endeavor, Foster teaches a wire rope that comprises a plurality of strands of conductive coils as well as polymer coils formed coaxially with the helically coiled conductor coils (e.g. Abstract, [0012], [0002]: one or more polymer filars or threads that are coiled around one or more conductive coils. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify wire rope in the teachings of Kuzma in view of Franz to include strands of non-conductive polymer as taught by Foster in order to provide the predictable results of improving torque compatibility and MRI compatibility.
While no prior art rejection has been made for claim 5, it is not indicated as allowable since it is unclear as to what is being claimed.
Conclusion
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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