DETAILED ACTION
Claims 6, 8, 9, 12, 13, 15-18 are withdrawn from consideration. A complete action on the merits of pending claims 1-5, 7, 10, 11, 14, 19 and 20 appears below.
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 .
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 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.
Election/Restrictions
Claims 6, 8, 9, 12, 13, 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/6/25.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7, 10, 14, 19, and 20 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Onik US 6379348.
Regarding claims 1, 19, and 20, Onik teaches an elongated medical needle assembly (Fig. 3 col 10 lines 9-15 it can have a sharp point), including: an elongated electrically-conductive flexible tube assembly having a distal portion (Fig. 3 exposed RF shaft 30 and distal 20, everything has some flexibility claim 11 is rejected with another reference because of the specificity) defining an elongated lumen extending longitudinally along an entire length of the elongated electrically-conductive flexible tube assembly toward the distal portion configured to be maneuvered (Fig. 3 50), at least in part, within the patient and toward the biological feature; and a first electrically-insulated layer covering, at least in part, an outer surface of the elongated electrically-conductive flexible tube assembly (Fig. 3 proximal 20); and a second electrically-insulated layer covering, at least in part, the distal portion of the elongated electrically-conductive flexible tube assembly (Fig. 3 distal 20).
Regarding claim 2, Onik teaches further comprising an electrically-exposed outer surface being located proximate to the distal portion, and also located between the first electrically-insulated layer and second electrically-insulated layer (Fig. 3 segment 40).
Regarding claim 3, Onik teaches wherein the electrically-exposed outer surface being configured to selectively emit energy toward the biological feature of the patient in response to selective movement of the energy along the elongated electrically-conductive flexible tube assembly toward the electrically-exposed outer surface (col 6 lines 4-6).
Regarding claim 7, Onik teaches wherein the elongated electrically-conductive flexible tube assembly includes two tubes having, respectively, a larger diameter proximal shaft section and a smaller diameter distal shaft section, with the electrically-exposed outer surface positioned on a distal shaft section (Fig. 3 proximal sheath 20 vs shaft 30).
Regarding claim 10, Onik teaches wherein: the elongated electrically-conductive flexible tube assembly includes: a proximal tube (Fig. 3 proximal sheath 20); and a distal tube; and the electrically-exposed outer surface is located on the distal tube and is spaced apart from the proximal tube (Fig. 3 shaft 30).
Regarding claim 14, Onik teaches wherein: the elongated electrically-conductive flexible tube assembly includes: a proximal tube (Fig. 3 proximal sheath 20); and a distal tube (Fig. 3 30); and the proximal tube and the distal tube are adhered together (Fig. 3 and col 5 lines 50-65).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 nonobviousness.
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Onik in view of Brown US 20020120263.
Regarding claims 4 and 5, Onik teaches the elongated electrically-conductive flexible tube assembly includes: a proximal tube; and a distal tube (Fig. 3 insulating layers 20 are sheaths).
Onik does not explicitly teach the electrically-exposed outer surface includes a surface roughness that is greater than the surface roughness of a reminder of the proximal tube and a distal tube; and the electrically-exposed outer surface includes a surface roughness that is greater than the surface roughness of a reminder of the distal tube.
Brown, in an analogous device, teaches where the conductive tissue engaging surfaces are rougher than the rest of the device (par. [0059]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the electrically exposed surfaces of Onik to be rough, as in Brown. The rough texture allows for the electrical surface to break through thin insulating layers surrounding tissue (par. [0059]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Onik in view of Hovda US 6468270.
Regarding claim 11, Onik teaches and the electrically-exposed outer surface is spaced apart from a portal lumen of the elongated lumen at the distal portion (Fig. 7 and col 4 lines 39-41 the shafts can have open ends).
Onik does not explicitly teach the elongated electrically-conductive flexible tube assembly is configured to form a single curve having a single radius; the electrically-exposed outer surface is located at a distal-most section of the single curve when in the elongated electrically-conductive flexible tube assembly is in its original, curved shape.
Hovda, in an analogous device, teaches where the conductive area 360 can be flexible and have a curve where the insulating surface is distal the curve making the conductive area the distal most section of the curve (Fig. 15C).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the tube of Onik to have the ability to curve, as in Hovda. Flexible tubes allow for the electrodes to be selectively placed on tissue (Hovda col 14 lines 10-13).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN T. CLARK whose telephone number is (408)918-7606. The examiner can normally be reached on Monday-Friday 7AM-3PM MT.
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/R.T.C./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794