DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Notice to Applicant
2. This communication is in response to the communication filed 11/16/2024. Claims 9-19 are cancelled. Claims 3-8 are currently amended. Claims 1-8 are currently pending.
Claim Rejections - 35 USC § 103
3. 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.
3.1. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
3.2. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
3.3. Claims 1-3 and 5-8 are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Deem et al. (US 2005/0288730).
CLAIM 1
Deem teaches a catheter adapted to be used in a method for locating or identifying a functional nerve innervating the wall of a blood vessel in a subject (Deem: abstract; ¶¶ [0038] “catheter”, [0049] “the system can determine the location of renal nerves and/or whether denervation has occurred”, [0135]-[0139]; FIG. 4), comprising:
a shaft (Deem: abstract; ¶¶ [0083]; FIG. 4);
wherein the proximal end of said shaft is configured to be connected to an energy source (Deem: abstract; ¶¶ [0083] “catheter 210 having a proximal section 211a, a distal section 211b, and a plurality of distal electrodes 212 at the distal section 211b, The proximal section 211a generally has an electrical connector to couple the catheter 210 to a pulse generator, and the distal section 211b in this embodiment has a helical configuration”; FIG. 4); and
the distal end (catheter tip) of said shaft is in the form of a single helix, double helix or multiple prongs having one or more electrodes (Deem: abstract; ¶¶ [0083]-[0085], [0088]-[0091]; FIGS. 4-5, 9).
CLAIM 2
Deem teaches the catheter of claim 1, wherein the one or more electrodes are configured to emit energy sufficient to stimulate or ablate a nerve on said vessel (Deem: abstract; ¶¶ [0049] “system can be configured to also deliver stimulation waveforms and monitor physiological parameters known to respond to stimulation of the renal nerves”; Claims 33, 36, 38, 55).
CLAIM 3
Deem teaches the catheter of claim 1, wherein the electrodes may be activated independently of one another (Deem: abstract; ¶¶ [0086]).
CLAIM 5
Deem teaches the catheter of claim 1, wherein the coil of said helix or said prongs are substantially round or flat in shape, and the electrodes are spaced along the length of said coil or prongs, wherein said electrodes are embedded in said coil or prongs, or lie on the surface of said coil or prongs (Deem: abstract; ¶¶ [0081], [0088], [0108]; FIGS. 4-9).
CLAIM 6
Deem teaches the catheter of claim 1, wherein the electrodes are evenly spaced along the length of said coil at 90° or 120° from each other (Deem: abstract; ¶¶ [0081], [0088], [0108]; FIGS. 4-9).
CLAIM 7
Deem teaches the catheter of claim 1, wherein the catheter tip is configured to hold a balloon inflatable to fill the space within the coil of said helix or prongs (Deem: abstract; ¶¶ [0089] “balloon catheter”; FIG. 6).
CLAIM 8
Deem teaches the catheter of claim 1, wherein said prongs are rejoined at the distal end (Deem: abstract; ¶¶ [0095]-[0101]; FIGS. 8-9).
3.4. Claim 4 is rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Deem et al. (US 2005/0288730), in view of Chambers (US 2007/0049899).
CLAIM 4
Deem does not appear to explicitly teach the catheter of claim 1, wherein the entire catheter is between 1 and 2 m in length, wherein the catheter tip is between 2 and 8 cm in length, and between 0.5 mm and 10 mm in diameter.
Chambers, however, teaches wherein the entire catheter is between 1 and 2 m in length, wherein the catheter tip is between 2 and 8 cm in length, and between 0.5 mm and 10 mm in diameter (Chambers: abstract; ¶¶ [0024]-[0033]; FIGS. 1-5F).
It would have been obvious to one of ordinary skill in the art, at the time of applicant’s invention, to include the catheter, as taught by Chambers, with the methods and apparatus for renal neuromodulation, as taught by Deem, with the motivation of facilitating catheterization of blood vessels (Chambers: ¶¶ [0001]-[0007]).
Conclusion
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681
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