DETAILED ACTION
A complete action on the merits of pending claims 1-20 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.
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 1-20 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 pre-AIA the applicant regards as the invention.
Claims 1, 2, 11, and 12 recite a minimum distance but define it as a range. A minimum is seen as the lowest number it can be not range of possibilities. Claims 3-10 and 13-20 are rejected based on dependency.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rivera US 20150157392 in view of Hutchins US 20020095146.
Regarding claims 1, 2, 4, 11, 12, and 13, Rivera teaches an elongate tubular member longitudinally extending from a proximal portion to a distal portion (Fig. 1 tubular member 106); an active path comprising a cutting edge exposed outside of the elongate tubular member (Fig. 1 cutting wire 112 with edge 118); and a return electrode disposed over an outer surface of the elongate tubular member (Fig. 1B and par. [0038] return electrode 120), wherein in an axial cross-section of the bipolar sphincterotome, the return electrode does not intersect a transverse axis of the bipolar sphincterotome, the transverse axis perpendicular to a longitudinal axis of the bipolar sphincterotome and to a radial direction defined by the cutting edge (Fig. 2 the axis would be horizontal somewhere around the top of 202).
Rivera does not explicitly teach wherein a minimum distance between the cutting edge and the return electrode is in a range of 0.060 inches to 0.080 inches and wherein an outer diameter of the elongate tubular member is in a range of about 0.050 inches to about 0.100 inches.
Hutchins, in an analogous device, teaches the proximal portion of the shaft is 0.09 inches and the distal part is 0.07 inches in diameter (par. [0046]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the shaft of Rivera to have a shaft with a diameter between 0.07 and 0.09 inches, as in Hutchins. A small diameter distal end allows for flexibility and a less traumatic tip (par. [0046]). With a diameter of 0.07 the tube would have a circumference of 0.22 and with a diameter of 0.09 a circumference of 0.28. If the return electrode covered half of the tube which it can as it states in par. [0042] a quarter of that would be 0.06 to 0.07 since the cutting electrode exits 90° from end of the return electrode.
Regarding claims 3 and 20, Rivera teaches wherein, over a longitudinal length distally extending from a plane perpendicular to the longitudinal axis and defined by a proximal end of an uninsulated portion of the cutting edge (Fig. 1B 112 coming out of 106), a ratio of a surface area of the return electrode to a surface area of the cutting edge is at least about 3:1 (Fig. 2 112 vs 120).
Regarding claims 5 and 14, Rivera teaches wherein the return electrode longitudinally extends at least one of: proximally past an exit port for the cutting edge or distally past an anchor point for the cutting edge (Fig. 1B).
Regarding claims 6 and 15, Rivera teaches wherein the return electrode distally extends past the anchor point (Fig. 1 116).
Regarding claims 7 and 16, Hutchins teaches wherein the return electrode longitudinally extends over a distal portion of the elongate tubular member that is configured to curl (Fig. 8).
Regarding claim 8, Rivera teaches wherein the return electrode does not intersect the transverse axis over at least half a longitudinal length of the return electrode (Figs. 1B and 2 the return electrode is less than half of the outer circumference of the shaft).
Regarding claim 9, Rivera teaches wherein the return electrode does not intersect the transverse axis over an entirety of the longitudinal length (Figs. 1B and 2 the return electrode is less than half of the outer circumference of the shaft).
Regarding claim 10, Rivera teaches wherein the elongate tubular member comprises at least one lumen in the axial cross-section (Fig. 2 202 or 204).
Regarding claim 17, Rivera teaches wherein the return electrode circumferentially extends less than 180 degrees about an outer surface of the elongate tubular member (par. [0042]) longitudinally over at least half a longitudinal length of the return electrode (Fig. 1B the length of 120).
Regarding claim 18, Rivera teaches wherein the return electrode circumferentially extends less than 180 degrees about the outer surface over the entirety of the longitudinal length (Fig. 1B and par. [0042] the longitudinal length is considered the length of 120).
Regarding claim 19, Rivera teaches wherein the return electrode circumferentially extends more than 180 degrees about an outer surface of the elongate tubular member such that the return electrode intersects a transverse axis of the bipolar sphincterotome in at least one location (par. [0042]).
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.
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, Linda Dvorak can be reached on (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.T.C./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794