DETAILED ACTION
Claims 1, 4, 5, 19, and 20 are amended. Claim 2 is canceled. Claims 6, 8, 9, 12, 13, 15-18 are withdrawn from consideration. A complete action on the merits of pending claims 1, 3-5, 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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claims 1, 3, 7, 10, 14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Onik US 6379348 in view of Curley US 20200015880.
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 terminating at a distal lumen end (Fig. 3 end of 40’), the elongated electrically-conductive flexible tube assembly 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 to the distal lumen end (Fig. 3 distal 20, 40’); and wherein the first electrically-insulated layer is longitudinally spaced from the second electrically-insulated layer exposing therebetween an electrically exposed outer surface proximal to the distal lumen end (Fig. 3 sheath 20 where 10 is pointing separated from sheath 20 at 40’ by RF shaft 30).
Onik does not explicitly a distal lumen poral but does teach a distal lumen end (Fig. 3 end of 40’).
Curley, in an analogous device, teaches the distal end of the lumen can be closed off or have ports at the distal end for fluid circulation (par. [0083] and Figs. 8 and 9). Curley further teaches where the ports can be orthogonal to the longitudinal direction of the shaft or the shaft can have an open distal end for the fluid to escape (par. [0098]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to substitute the closed loop configuration of Onik to be an open look configuration, as in Curley. They are seen to preform equally as well and would yeild the predictable result of temperature regulation during tissue treatment (Curley par. [0083]).
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).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Onik in view of Curley as applied to claim 1 above, and further in view of 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 and Curley do not explicitly teach the electrically-exposed outer surface includes a surface roughness that is greater than the surface roughness of a remainder 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 remainder 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 and Curley 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 Curley as applied to claim 1 above, and further in view of Hovda US 6468270.
Regarding claim 11, Onik and Curley teach the electrically-exposed outer surface is spaced apart from a portal lumen of the elongated lumen at the distal portion (rejection of claim 1 where the port is at the distl end of the device).
Onik and Curley do 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 and Curley 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).
Response to Arguments
Applicant’s arguments with respect to claims 1, 19, and 20 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 Monday-Friday 7AM-3PM MT.
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, Joseph Stoklosa can be reached at (571)272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.T.C./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights