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
Claims 6-9 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species/embodiment, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/20/26.
Applicant's election with traverse of the election of species in the reply filed on 7/20/26 is acknowledged. The traversal is on the ground(s) that the examiner has not provided a reason such as a serious examination burden across multiple classifications. This is not found persuasive because a serious search burden is not a requirement for applications filed under national stage/371. The serious search burde The argument that the same search will find similar art and the examination burden will be the same is not persuasive for the same reasons above as this case is a national stage application. In addition, the applicant has not stated on the record that the two embodiments are obvious variants, and finding one embodiment in the prior art will necessarily result in rejecting the other embodiment as an obvious variant. The argument that the lack of unity of invention is not sufficient to maintain the election of species/restriction is not persuasive as this is what is required and was provided in the examiner’s election of species/restriction to maintain the lack of unity of invention, and since it was provided, it is a proper election of species/restriction.
The requirement is still deemed proper and is therefore made FINAL.
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 1-5, 10-12, and 14-18 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, line 6, “its” is vague as it is unclear what element “its” is referring to. It is suggested to specifically point out the element that “its” applies to. In line 9, “itself” is vague as it is unclear what element this is referring to. In lines 9-10, “being connected to an electrical connection…connected to an electrode on an electrical pulse generator” is vague, inferentially including the electrical connection, electrode, and pulse generator. It is unclear if the applicant means to positively recite/claim the electrical connection, electrode, and pulse generator, or if the applicant means these elements as an intended/functional use recitation. As the claim is positively reciting a connection to these elements, the examiner has interpreted the claim as containing these elements and the claim should be amended accordingly, such as putting in line 4, “an electrical pulse generator having an electrode and an electrical connection” and then adding in lines 9-10, “the” before those elements. In line 12, “the introducer sheath” lacks antecedent basis and it is unclear what element this is referring to. In line 14, “it” and “its” is vague. In the last paragraph, “the other electrode” lacks antecedent basis.
In claim 2, line 3, “the one” is vague as it is unclear what element this is.
In claim 3, “its” is vague.
In claim 5, “typically of external diameters of between 1.6-20 mm” is vague and it is unclear if the claim or prior art requires this diameter or not since “typically” is used. If the prior art does not have this diameter, it would still meet the claims as typically does not require 100% usage.
In claim 10, “the axis of the wire” is vague as it is unclear which axis is being discussed (longitudinal axis of the rectilinear wire? Or a perpendicular axis to the longitudinal axis? Etc.).
Claims 11 and 12 are vague and conflict with claim 10. Claim 10 states the elongate element is a “rectilinear” wire, or a straight wire, but claims 11 and 12 have loops or rings, which conflicts with the straight wire.
In claim 14, the claim is vague and seems to conflict with claim 1. Claim 1 has the elongate element being 3 elements—a conductive distal portion, an insulative central portion, and an electrically conductive proximal portion that allows connection to the pulse generator to deliver stimulation to the distal portion. Now claim 14 describes it as being 2 elements—a guide wire and a nitinol section that comes apart. It is unclear which of the 3 elements of claim 1, correspond to the 2 elements of claim 14. In addition, how is there still stimulation or connection to the external pulse generator when the guidewire is being withdrawn? In lines 3 and 4, “its” is vague. It is unclear what elements are being set forth in claim 14 and the claim could not be further examined in view of the prior art.
Claim 17 is vague as it is unclear what the claim is further adding to claim 1. Claim 1 is to a kit, while claim 17 is to a kit “for transvascular renal nerve stimulation”. Is there another element/limitation added in claim 17 that is additional to claim 1? What is that element/limitation? In addition, “furthermore a renal denervation kit” is vague as it is unclear what additional element/limitation this adds.
Similarly, claim 18 is vague as it is unclear what elements/limitations the “kit for stimulation of the carotid body” and “furthermore a kit for delivery of a stent or a balloon…” add.
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.
Claims 1-5, 10, 17 and 18 are rejected under 35 U.S.C. 102a1 as being anticipated by Faurie (2019/0224011). Faurie discloses the claimed limitations as follows:
--an introducer or guide catheter (e.g. figure 1, abstract, para. 105, 118, 172, etc.)
--a sleeve fitted around the introducer made of electrically conductive material (e.g. figures 5, 6, paras. 163-168, 105, 118, etc.) connected to an electrode of an electrical pulse generator (e.g. figure 5, paras. 57-58, etc.)
--an elongate stimulation element to be inserted into the introducer (e.g. guidewire, bipolar guidewire, figures 9-10, paras. 184-186, 57, 105, 118, etc.) having an electrically conductive portion atraumatic to the blood vessel, electrical insulating central portion, and an electrically conductive proximal portion for connection to the other electrode of the pulse generator (e.g. figure 9, element 6d, paras. 184-186, etc.; in the alternative for the guidewire having an electrically insulating central portion, see the 103 rejection below).
The system of Faurie is capable of meeting the functional/intended use limitation of being for transvascular stimulation of part of an autonomic nervous system of the body since it is the same/similar size as the applicants, contains the same components of a sleeve, introducer, electrical pulse generator, and catheter/guide wire, and contains implantable/insertable elements that can be introduced into a blood vessel of a human and stimulates body structures at the distal end of the guide wire.
For claim: 2, sleeve being the anode, other one being the cathode (e.g. paras. 52-58, etc.); 3, one piece conductive material (e.g. paras. 165-168, etc.); 4, electrically conductive coating (e.g. paras. 165-168, etc.); 5, diameter between 1.6-20 mm (e.g. para. 62, etc.); 10, being a rectilinear wire with contact shape extending radially along the axis of the wire (e.g. figure 9, etc., in the alternative, see the 103 rejection below); 17 and 18, no additional elements appear to be set forth for these claims, except for how the system is used in an intended/functional use recitation. Faurie is similarly able to be used for renal nerve stimulation or carotid body stimulation for the reasons given above for transvascular stimulation.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
In the alternative, claims 1-5, 10, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Faurie. Faurie discloses the claimed limitations as discussed above in the 102 rejection. In the alternative for the centrally insulative part on the guide wire, it would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed, to have modified the system and method as taught by Faurie, with an electrically insulative central portion on the guide wire, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of allowing the physician to grasp the guidewire without being shocked and/or provide an insulative central portion between the distal tip electrode and the patient’s body to ensure that stimulation only occurs at the target location of the distal tip and nowhere else in the body.
Claims 10-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Faurie in view of Ku et al (2016/0113713). Ku discloses the claimed invention and introduction of an electrode in the body, but does not disclose the contact shape which extends radially along the axis of the wire being at least one distal loop or distal ring (e.g. claims 10-12), or the distal portion of the elongate element having a radiopaque marker (e.g. claim 16). Ku discloses that the distal end of the stimulation wire is a distal loop or distal ring (e.g. figure 4B, open loop, having ring/loop electrodes 24/124, etc.) to provide an atraumatic distal section that can stimulate the tissue no matter how the lead is oriented, and using a radiopaque marker on the distal end (e.g. para. 120, etc.) so to allow the physician to know where the lead is located in the body. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed, to have modified the system and method as taught by Faurie, with the contact shape which extends radially along the axis of the wire being at least one distal loop or distal ring and the distal portion of the elongate element having a radiopaque marker, as taught by Ku, since it would provide the predictable results of providing an atraumatic distal section that can stimulate tissue no matter how the lead is oriented, and allowing the physician to know where the lead is located in the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 9/19/26
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