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 .
A complete action on the merits of pending claims 1-20 appears herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 11 of U.S. Patent No. 10,335,225. Although the claims at issue are not identical, they are not patentably distinct from each other because they comprise overlapping subject matter with minor grammatical differences.
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.
Claim(s) 1-4, 6-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hacker (US 2018/0140349 A1).
Regarding claim 1, Hacker teaches
an elongated shaft comprising a lumen extending along a longitudinal axis from a proximal end portion to a distal end portion; (Fig. 1-3, Char. 30: shaft)
a supply electrode (Fig. 3, Char. 14: active electrode) forming an electrode face directed laterally from the longitudinal axis at the distal end portion, (Fig. 3) the electrode face comprising at least one aperture in connection with the lumen; (Fig. 3, Char. 46: aspiration inlet)
a return electrode extending along the distal end portion of the elongated shaft; (Fig. 6, Char. 38: return electrode) and
an insulator interposed between the supply electrode and the return electrode, (Fig. 3 and 6, Char. 40: insulator) the insulator forming a transition passage of the lumen interconnecting the at least one aperture to the lumen (Fig. 6) along an arcuate swept path. (Fig. 6: The transition between the bottom surface (72) of the internal aspiration collection chamber and the distal linear surface (62) is curved)
Regarding claim 2, Hacker further teaches the elongated shaft extends to a distal extent of the ablation apparatus and the return electrode extends over a portion of the distal extent. (Fig. 6)
Regarding claim 3, Hacker further teaches the transition passage forms an inlet cross section that decreases along the transition passage to an outlet cross section in connection with the lumen. (Par. [0026])
Regarding claim 4, Hacker further teaches a cross section of the internal passage forming the transition passage is swept from the longitudinal axis along the lumen to the at least one aperture extending laterally from the longitudinal axis. (Fig. 6: The transition between the bottom surface (72) of the internal aspiration collection chamber and the distal linear surface (62) is curved)
Regarding claim 6, Hacker further teaches the elongated shaft forms a tapered end portion opposing the electrode face. (Fig. 5-6)
Regarding claim 7, Hacker further teaches the elongated shaft tapers gradually along the longitudinal axis to a distal extent of the ablation apparatus on a first side opposing the electrode face as well as a second side and a third side extending along opposing sides of the electrode face. (Fig. 3, 5-6)
Regarding claim 8, Hacker further teaches the tapered end portion tapers along a slope that increases with increasing proximity to the distal extent. (Fig. 5-6)
Regarding claim 10, Hacker further teaches the supply electrode extends approximately equidistant from the return electrode along at least a distal 25% of an electrode length Le of the supply electrode. (Fig. 5)
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.
The factual inquiries 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.
Claim(s) 9, 11, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hacker (US 2018/0140349 A1), as applied to claim 1 above, and further in view of Aluru (US 9,254,166 B2).
Regarding claim 9, Hacker, as applied to claim 1 above, teaches the supply electrode forms a perimeter edge adjacent to the insulator and extends from a proximal electrode portion to a distal electrode portion. (Hacker Fig. 4 and 6)
Hacker, as applied to claim 1 above, is silent regarding wherein the perimeter edge is evenly spaced from the return electrode along the distal end portion.
Aluru, in a similar field of endeavor, teaches an ablation device comprising an active electrode (Fig. 2B, Char. 104: active electrode) and a return electrode (Fig. 2B, Char. 112: return electrode) separated by an insulative support member; (Fig. 2B, Char. 150: support member) wherein the active electrode and return electrode are equally spaced from each other along the length of the insulative support member. (Fig. 2B)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hacker, as applied to claim 1 above, to incorporate the teachings of Aluru, and configure the return electrode (38) of Hacker to be of whatever form or shape was desired or expedient, including parallel to active electrode (14) of Hacker, such that the active electrode (14) and return electrode (38) are evenly spaced from each other along the entire length of active electrode (14). Doing so would result in a more uniform tissue effect along the perimeter of the active electrode, as suggested in Aluru. (Col. 12, Line 63 – Col. 13, Line 1) A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 11, Hacker, as applied to claim 1 above, is silent regarding the approximately equidistant spacing between the supply electrode and the return electrode includes an average spacing that is evenly spaced on average over the distal end portion including variations in a perimeter edge of the supply electrode and a return edge of the return electrode.
Aluru, in a similar field of endeavor, teaches an ablation device comprising an active electrode (Fig. 2B, Char. 104: active electrode) and a return electrode (Fig. 2B, Char. 112: return electrode) separated by an insulative support member; (Fig. 2B, Char. 150: support member) wherein the active electrode and return electrode are equally spaced from each other along the length of the insulative support member. (Fig. 2B)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hacker, as applied to claim 1 above, to incorporate the teachings of Aluru, and configure the return electrode (38) of Hacker to be of whatever form or shape was desired or expedient, including a shape such that the supply electrode and the return electrode include an average spacing that is evenly spaced on average over the distal end portion including variations in a perimeter edge of the supply electrode and a return edge of the return electrode. Doing so would result in a more uniform tissue effect along the perimeter of the active electrode, as suggested in Aluru. (Col. 12, Line 63 – Col. 13, Line 1) A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 14, Hacker teaches
supplying a control signal to supply electrode of an ablation device; (Par. [0023]: Energy is transferred between active electrode (14) and return electrode (38))
conducting the control signal through the supply electrode to a return electrode across an insulating gap, (Fig. 5-6 and Par. [0023]: Energy is transferred between active electrode (14) and return electrode (38)) and conducting the control signal across an insulating gap generates an edge ablation region extending about the distal end portion of the ablation device between the supply electrode and the return electrode; (Par. [0030]) and
communicating fluid through a lumen extending through an elongated shaft of the ablation device. (Par. [0025])
Hacker, as applied to claim 14 above, is silent regarding wherein the insulating gap is approximately constant over a distal end portion of the supply electrode.
Aluru, in a similar field of endeavor, teaches an ablation device comprising an active electrode (Fig. 2B, Char. 104: active electrode) and a return electrode (Fig. 2B, Char. 112: return electrode) separated by an insulative support member; (Fig. 2B, Char. 150: support member) wherein the active electrode and return electrode are equally spaced from each other along the length of the insulative support member. (Fig. 2B)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hacker, as applied to claim 1 above, to incorporate the teachings of Aluru, and configure the return electrode (38) of Hacker to be of whatever form or shape was desired or expedient, including shaped such that the insulating gap is approximately constant over a distal end portion of the supply electrode. Doing so would result in a more uniform tissue effect along the perimeter of the active electrode, as suggested in Aluru. (Col. 12, Line 63 – Col. 13, Line 1) A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 15, the combination of Hacker/Aluru, as applied to claim 14 above, teaches the communicating fluid through a lumen of the ablation device comprises: communicating the fluid through at least one aspiration port (Hacker: Par. [0025]) extending laterally from the lumen and through the supply electrode. (Hacker: Fig. 4-6)
Regarding claim 16, the combination of Hacker/Aluru, as applied to claim 15 above, teaches the communicating fluid through a lumen of the ablation device further comprises: steering the fluid along an arcuate path (Hacker: Fig. 6: The transition between the bottom surface (72) of the internal aspiration collection chamber and the distal linear surface (62) is curved) from the at least one aspiration port to the lumen. (Hacker: Fig. 6 and Par. [0025])
Regarding claim 17, the combination of Hacker/Aluru, as applied to claim 16 above, teaches the communicating of the fluid further comprises communicating the fluid through a decreasing cross-sectional area along the arcuate path from the supply electrode to the lumen. (Hacker: Par. [0026])
Claim(s) 5, 12, 13, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hacker (US 2018/0140349 A1), as applied to claim 1 above, and further in view of Swanson (US 2007/0156185 A1).
Regarding claims 5, 12 and 13, Hacker, as applied to claim 1 above, is silent regarding the electrode face forms an ovular shape comprising a proximal electrode portion and a distal electrode portion, and a major axis of the ovular shape extends parallel to the longitudinal axis; wherein the electrode face of the supply electrode forms a distal electrode portion that tapers outward from the longitudinal axis of the apparatus to a proximal end portion; and wherein the proximal electrode portion forms a first arc comprising a first radius and the distal electrode portion forms a second arc comprising a second radius, wherein the first radius is greater than the second radius.
Swanson, in a similar field of endeavor, teaches forming electrodes in whatever shape is convenient or desired, including an ovular shape. (Par. [0129])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hacker, as applied to claim 1 above, to incorporate the teachings of Swanson, and configure the active electrode (14) of Hacker to be of whatever form or shape was desired or expedient, including the claimed ovular shape of claims 5, 12, and 13. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 19, Hacker teaches
an elongated shaft comprising a lumen extending along a longitudinal axis from a proximal end portion to a distal end portion; (Fig. 1-3, Char. 30: shaft)
a supply electrode forming an electrode face (Fig. 4, Char. 14: active electrode) directed laterally from the longitudinal axis (Fig. 4-6) at the distal end portion and comprising at least one aperture in connection with the lumen, (Fig. 3, Char. 46: aspiration inlet) the electrode face having a shape comprising: (Fig. 3)
a proximal electrode portion forming a first arc comprising a first radius; (Fig. 3: The proximal half of active electrode (14)) and
a distal electrode portion forming a second arc comprising a second radius; (Fig. 3: The distal half of active electrode (14))
a return electrode extending along the distal end portion of the elongated shaft; (Fig. 6, Char. 38: return electrode) and
an insulator interposed between the supply electrode and the return electrode, (Fig. 3 and 6, Char. 40: insulator) the insulator forming a transition passage of the lumen interconnecting the at least one aperture to the lumen. (Fig. 6)
Hacker, as applied to claim 19 above, is silent regarding the shape of the electrode face being an ovular shape comprising a first major axis parallel to the longitudinal axis; and wherein the first radius is greater than the second radius.
Swanson, in a similar field of endeavor, teaches forming electrodes in whatever shape is convenient or desired, including an ovular shape. (Par. [0129])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hacker, as applied to claim 1 above, to incorporate the teachings of Swanson, and configure the active electrode (14) of Hacker to be of whatever form or shape was desired or expedient, including an ovular shape comprising a first major axis parallel to the longitudinal axis; and wherein the first radius is greater than the second radius. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 20, the combination of Hacker/Swanson, as applied to claim 19 above, teaches the distal end portion of the ablation apparatus forms a torpedo shape that tapers to a distal extent of the ablation apparatus along opposing edges of electrode face and along a rear surface opposite the electrode face. (Hacker Fig. 3 and 6)
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker (US 2018/0140349 A1), in view of Aluru (US 9,254,166 B2), as applied to claim 14 above, and further in view of Bagaoisan (US 2010/0168789 A1).
Regarding claim 18, the combination of Hacker/Aluru, as applied to claim 14 above, is silent regarding passing an acting end of the ablation device through a rigid cylindrical access envelope having a diameter and a length, wherein the diameter is less than two times a width of the elongated shaft and the length is at least two times the width.
Bagaoisan, in a similar field of endeavor, teaches passing an acting end of a surgical device (Fig. 6B, Char. 120: cartridge) through a rigid cylindrical access envelope having a diameter and a length, (Fig. 1B and 6B, Char. 20: introducer sheath; Par. [0039]: Introducer sheath may be formed from a substantially rigid tubular body) wherein the diameter is less than two times a width of the elongated shaft (Fig. 6B) and the length is at least two times the width. (Fig. 6B)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Hacker/Aluru, as applied to claim 14 above, to incorporate the teachings of Bagaoisan, and pass an acting end of the ablation device through a rigid cylindrical access envelope having a diameter and a length, wherein the diameter is less than two times a width of the elongated shaft and the length is at least two times the width. Doing so would minimize the risk of accidental damage from occurring to surrounding tissue and/or the instrument (10) of Hacker from occurring during navigation to/from the target treatment zone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794