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 .
Claims 1-8 and 16-20 are withdrawn from consideration. A complete action on the merits of pending claims 9-15 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 9-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-9 of copending Application No. 17/951,387 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the two sets of claims contain overlapping subject matter with minor grammatical changes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 9-15 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation “an energy transfer element disposed at a position where one of the proximal side sandwiching strut and the distal side sandwiching strut of the main strut such that the energy transfer element sandwiches biological tissue” This limitation renders the claim unclear as to the position of the energy transfer element relative to the one of the proximal side sandwiching strut and the distal side sandwiching strut. For the purpose of examination, the limitation “an energy transfer element disposed at a position where one of the proximal side sandwiching strut and the distal side sandwiching strut of the main strut such that the energy transfer element sandwiches biological tissue” is interpreted as “an energy transfer element disposed on one of the proximal side sandwiching strut and the distal side sandwiching strut of the main strut such that the energy transfer element sandwiches biological tissue” Claims 10-15 are rejected due to their respective dependencies on claim 9.
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) 9 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goedeke (US 2018/0161577 A1).
Regarding claim 9, Goedeke teaches
a plurality of main struts arranged at intervals in a circumferential direction and extending along an axis of the expansion body, (Fig. 36E, Char. 3632: splines) each of the main struts includes a proximal side main strut, (Attached “Annotated Goedeke Fig 36E” below: the portion of splines (3632) labelled “proximal side main strut,” between the proximal hub and the point of spline (3632) labelled Point A) a proximal side sandwiching strut, (Attached “Annotated Goedeke Fig 36E” below: the portion of splines (3632) labelled “proximal side sandwiching strut” between the points of spline (3632) labelled Point A and Point B.) a distal side sandwiching strut, (Attached “Annotated Goedeke Fig 36E” below: the portion of splines (3632) labelled labelled “distal side sandwiching strut” between the points of spline (3632) labelled Point B and Point C.) and a distal side main strut; (Attached “Annotated Goedeke Fig 36E” below: the portion of splines (3632) labelled “distal side main strut” between the point of spline (3632) labelled Point C and the distal hub.)
each of the proximal side main struts being inclined so as to increase in a radial direction from a distal portion of the outer tube (Fig. 36D, Char. 3607: proximal hub) toward a distal direction, and the distal side main strut is inclined so as to increase in the radial direction from a force reception portion (Fig. 36D, Char. 3608: distal hub) toward a proximal direction of the expansion body; (Fig. 36E)
each of the proximal side sandwiching struts being inclined so as to decrease in the radial direction from a distal portion of the proximal side main strut toward the distal direction; (Fig. 36E)
each of the distal side sandwiching struts being inclined so as to decrease in the radial direction from a proximal portion of the distal side main strut toward the proximal direction; (Fig. 36E)
wherein the proximal side sandwiching strut and the distal side sandwiching strut are connected to each other by an inward protruding portion protruding inward in the radial direction; and (Attached “Annotated Fig. 36E” below: The portion of spline (3632) at point B at which the angle of said spline relative to the longitudinal axis is zero)
each of the plurality of main struts including an energy transfer element disposed at a position where one of the proximal side sandwiching strut and the distal side sandwiching strut of the main strut such that the energy transfer element sandwiches biological tissue with another of the proximal side sandwiching strut and the distal side sandwiching strut of the main strut. (Fig. 36C and 36E; and Par. [0835]: Electrodes shown in Fig. 36C are disposed on the portions of splines (3632) labelled “proximal side sandwiching strut” and “distal side sandwiching strut” in attached “Annotated Goedeke Fig 36E” below.)
Annotated Goedeke Fig. 36E
PNG
media_image1.png
407
546
media_image1.png
Greyscale
Regarding claim 14, Goedeke further teaches a pulling shaft (Fig. 36C, Char. 3628: actuator wire) configured to be disposed at least partially inside the outer tube, the pulling shaft being connected to the expansion body. (Fig. 36C; and Par. [0921])
Regarding claim 15, Goedeke further teaches the pulling shaft includes an inner tube movable inside the outer tube in an axial direction, and an engagement portion fixed to a distal portion of the inner tube, (The point of attachment between actuator wire (3628) and the distal hub) the engagement portion configured to be pulled toward a proximal direction by the inner tube to compress the expansion body in the axial direction. (Fig. 36C; and Par. [0921]: Rotation and/or longitudinal movement of the actuation mechanism (3612) can cause the actuator wire (3628) to proximally retract)
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goedeke (US 2018/0161577 A1) in view of Pomeranz (US 5,345,936).
Regarding claim 10, Goedeke, as applied to claim 9 above, is silent regarding a plurality of sub-struts connected to the plurality of main struts, the plurality of sub-struts include a distal side sub-strut on a distal side of the inward protruding portion, and a proximal side sub-strut on a proximal side of the inward protruding portion.
Pomeranz, in a similar field of endeavor, teaches disposing a plurality of sub-struts (Fig. 1, Char. 46: fibers) to connect adjacent basket splines. (Fig. 1 and Col. 3, Lines 10-15)
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 Goedeke, as applied to claim 9 above, to incorporate the teachings of Pomeranz, and include the fibers (46) of Pomeranz along the splines (3632) of Goedeke, including a distal side fiber on a distal side of the inward protruding portion, and a proximal side fiber on a proximal side of the inward protruding portion. Doing so would help ensure substantially uniform circumferential spacing between the splines (3632) of Goedeke, as suggested in Pomeranz.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goedeke (US 2018/0161577 A1) in view of Pomeranz (US 5,345,936) in view of Wang (CN 112120780 A).
Regarding claim 11, the combination of Goedeke/Pomeranz, as applied to claim 10 above, is silent regarding a distal side support strut at a distal portion of the distal side sub-strut, the distal side support strut being connected to two circumferentially adjacent distal side main struts; and a proximal side support strut at a proximal portion of the sub-strut, the proximal side support strut being connected to two circumferentially adjacent distal side sandwiching struts.
Wang, in a similar field of endeavor, teaches a basket catheter structure (Fig. 4) comprising a support strut (Fig. 4, Char. 231: wave crest) being connected to two circumferentially adjacent main strut portions located distal to the support strut (Fig. 4, Char. 251: first connecting rod) and two circumferentially adjacent main strut portions located proximal to the support strut (Fig. 4, Char. 271: second connecting rod) via distal connecting struts and proximal connecting struts respectively. (Fig. 4)
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 Goedeke/Pomeranz, as applied to claim 10 above, to incorporate the teachings of Wang, and configure the fibers (60) of Pomeranz to include support struts connected to circumferentially adjacent portions of the splines (3632) of Goedeke located distally and proximally to the support strut. Doing so would provide more structural support for the basket structure due to the increased number of support struts between splines (3632).
In this combination, fibers (60) of Pomeranz disposed longitudinally between the distal side main strut portion of splines (3632) of Goedeke and the distal side sandwiching strut portion of splines (3632) would have the distally extending support struts attach to the distal side main strut portion of splines 3632 and the proximally extending support struts attach to the distal side sandwiching strut portion of splines 3632.
Regarding claims 12 and 13, the combination of Goedeke/Pomeranz/Wang, as applied to claim 11 above, is silent regarding the proximal side sub-strut is connected to two circumferentially adjacent proximal side main struts, the proximal side sub-strut including two inclined struts inclined with respect to an axis of the expansion body when viewed from a radially outer side; wherein the two inclined struts extend toward the proximal direction while approaching the respective circumferentially adjacent proximal side main struts, and are connected to each other at a merging portion, and wherein the two inclined struts connected to the merging portion are plane-symmetrical with respect to a plane passing through the merging portion and the axis of the expansion body.
However, absent a statement of criticality AND unexpected results for the specifically claimed sub-strut structure it would have been an obvious matter of design choice to a person of ordinary skill in the art to arrange the support struts taught by Wang and fibers (60) of Pomeranz in the claimed configuration because, as best understood by examiner, applicant has not disclosed that the specifically claimed sub-strut arrangement of claims 12 and 13 provides an advantage, is used for a particular purpose, or solves a stated problem. Furthermore, one of ordinary skill in the art would have expected the support strut/fiber arrangement in the Goedeke/Pomeranz/Wang combination applied to claim 11 above and applicant’s invention to perform equally well because both sub-strut arrangements would perform the same function of strengthening/supporting the basket structure. Therefore, it would have been prima facie obvious to modify the combination of Goedeke/Pomeranz/Wang, as applied to claim 11 above, to obtain the invention as specified in claims 12-13 because such a modification would have been considered a mere design consideration.
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.
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 at 5712724764. 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.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./ Examiner, Art Unit 3794