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 .
Response to Amendment
Claims 1-24 are pending in the application. Claims 25-52 have been canceled. Claims 1, 3, 6, and 12-24 have been amended.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed on 6/25/26 is acknowledged.
Claims 12-24 (formerly Group II) have been amended to depend on claim 1. Claims 1-24 will be examined.
Claim 37 (formerly Group III) has been canceled.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,239,292 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, US 12,239,292 B2 discloses a system for applying an occlusion clip to an anatomical structure (claim 11), the system comprising: a clip applier configured to apply an occlusion clip on the anatomical structure (claim 11); and an introducer connectable to the clip applier and configured to aid in positioning the clip applier proximate the anatomical structure (claim 11).
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Monassevitch et al. (US 2010/0331862 A1) (“Monassevitch”).
Regarding claim 1, Monassevitch discloses (Figures 1-85) a system for applying an occlusion clip (10) to an anatomical structure, the system comprising: a clip applier (30) configured to apply an occlusion clip on the anatomical structure; and an introducer (150) connectable to the clip applier (via lumen 158; paragraph 0285) and configured to aid in positioning the clip applier proximate the anatomical structure (P, Figure 65).
Regarding claim 2, Monassevitch discloses (Figure 1A) a positioner (306) configured to apply at least one of a linear force and a torsional force to at least one of the clip applier and the occlusion clip (paragraph 0153).
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.
Claims 1, 7-10, 12-15, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sugarbaker (5,766,187) in view of Davis (US 3,856,016).
Regarding claim 1, Sugarbaker discloses a system for treating an anatomical structure, the system comprising: an instrument (60) configured to treat the anatomical structure; and an introducer (2) connectable to the instrument and configured to aid in positioning the instrument proximate the anatomical structure (Figure 1). Sugarbaker fails to disclose that the instrument is a clip applier for applying an occlusion clip to the anatomical structure. Sugarbaker discloses that the instrument is a stapler (60). However, Sugarbaker discloses that the instrument can be utilized to apply a clamp to an anatomical structure (Column 1, lines 43-47). Sugarbaker further discloses surgical procedures in other areas and on other organs or any other structure requiring careful and precise manipulation of a surgical instrument in open or traditional surgery as well as endoscopic surgery (Column 2, lines 6-12).
Davis teaches (Figures 1-14) a clip applier that is utilized in procedures to apply an occlusion clip to an anatomical structure (Column 9, lines 29-37).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the instrument disclosed by Sugarbaker to be a clip applier that applies an occlusion clip to an anatomical structure, as taught by Davis. Sugarbaker discloses that the instrument can be utilized to apply a clamp to an anatomical structure (Column 1, lines 43-47). Davis teaches that a single clip can be applied to occlude the anatomical structure (Column 9, lines 34-37).
Regarding claim 7, Sugarbaker as modified by Davis teaches (Sugarbaker, Figures 3 and 5) that the introducer (2) comprises an elongated, generally flexible distal section (4 extending to end 32) and an elongated, generally flexible proximal section (28 extending to 14); and wherein a proximal end portion (32) of the distal section is capable of releasably coupling to a distal end portion of the proximal section (Column 4, lines 30-31).
Regarding claim 8, Sugarbaker as modified by Davis teaches (Sugarbaker, Figures 3 and 5) that the proximal end portion (4) of the distal section comprises a first connector (32) and the distal end portion of the proximal section comprises a second connector (28); and wherein the first connector and the second connector are releasably connectable (Column 4, lines 30-31).
Regarding claim 9, Sugarbaker as modified by Davis teaches (Sugarbaker, Figure 1) that the clip applier (as modified by Davis) comprises a distal tip portion, the distal tip portion comprising a third connector; and wherein the second connector is connectable to the third connector to connect the introducer to the clip applier (Sugarbaker, Column 4, line 63 – Column 5, line 10).
Regarding claim 10, Sugarbaker as modified by Davis teaches that when the second connector is connected to the third connector, the second connector and the third connector are not readily detachable by pulling apart the second connector and the third connector (Sugarbaker, Column 4, line 63 – Column 5, line 10).
Regarding claim 12, Sugarbaker as modified by Davis teaches (David, Figures 1-15) shaft (50) that is elongated; a handle (108) disposed at a proximal end portion of the shaft; and an end effector (32, 34) disposed at a distal end portion of the shaft; wherein the end effector is configured to deliver and apply the occlusion clip (10) onto an the anatomical structure; wherein the end effector comprises a distal tip portion that is capable of connecting to the a distal end portion of the introducer.
Regarding claim 13, Sugarbaker as modified by Davis teaches that the shaft is at least one of substantially rigid, generally flexible, substantially malleable, and steerable (Davis, Column 1, lines 53-56).
Regarding claim 14, the shaft (50) taught by Sugarbaker as modified by Davis is capable of transmitting torque between the handle (108) and the end effector (Column 4, lines 33-35).
Regarding claim 15, Sugarbaker as modified by Davis teaches (Davis, Figures 5-11) that the end effector (32, 34) includes at least one articulation joint (Davis, Column 4, lines 27-39).
Regarding claim 18, Sugarbaker as modified by Davis teaches (Davis, Figures 5-11) that the end effector comprises a first jaw (32) and a second jaw (34); wherein at least one of the first jaw and the second jaw is articulable to open and close the occlusion clip (Davis, Column 4, lines 27-39); and wherein the first jaw comprises a jaw member and the distal tip portion, the distal tip portion capable of releasably attaching to the jaw member (Sugarbaker, Figure 1; Column 4, lines 63-65).
Regarding claim 19, Sugarbaker as modified by Davis teaches (Davis, Figures 1, 2, 4, 12-14) that the occlusion clip (10) comprises an open-ended occlusion clip releasably coupled to the first jaw and the second jaw; and wherein a distal portion of the second jaw is generally rounded to facilitate atraumatic insertion and positioning of the end effector (Figures 7 and 11).
Regarding claim 20, Sugarbaker as modified by Davis teaches (Sugarbaker, Figures 3 and 5) the distal end portion of the introducer (2) comprises a first connector (8); wherein the distal tip portion of the end effector comprises a second connector (Figure 1); and wherein the first connector and the second connector are connectable (Figure 1).
Regarding claim 21, Sugarbaker as modified by Davis teaches (Sugarbaker, Figures 3 and 5) that the first connector is capable of releasably coupling with the second connector (Sugarbaker, Column 4, lines 63-65; Column 5, lines 7-8).
Regarding claim 22, Sugarbaker as modified by Davis teaches that the first connector and the second connector are configured so that, when connected together, the first connector and the second connector are not readily detachable by pulling apart the first connector and the second connector (Sugarbaker, Column 4, line 63 – Column 5, line 10).
12. Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Monassevitch et al. (US 2010/0331862 A1) (“Monassevitch”) in view of Okada (US 4,085,742).
Regarding claim 3, Monassevitch discloses a visualization tool (300) configured to allow visualization of an anatomical structure using a scope (endoscope), wherein the visualization tool comprises: an elongated, generally rigid shaft (paragraph 0039); a handle (Figure 1C) disposed at a proximal end portion of the shaft. However, Monassevitch fails to disclose a scope hood disposed at a distal end portion of the shaft.
Okada teaches that it was known in the art before the effective filing date of the claimed invention for visualization tools to comprise a scope hood disposed at a distal end portion of the shaft. Okada teaches that a scope hood provides a smooth outer surface to prevent injury to the inner surface of a body cavity and prevents a foreign substance from being excessively deposited onto the front end surface endoscope (Column 1, lines 21-30).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the visualization tool disclosed by Monassevitch to comprise a scope hood disposed at a distal end portion of the shaft, as taught by Okada. This modification would provide a smooth outer surface to prevent injury to the inner surface of a body cavity and would prevent a foreign substance from being excessively deposited onto the front end surface endoscope (Okada, Column 1, lines 21-30).
Regarding claim 4, Monassevitch as modified by Okada teaches the visualization tool (300) comprises a first channel (154) extending longitudinally through the shaft; and wherein the first channel is configured to receive at least one of a guidewire, a guide sheath, and the introducer therethrough (Monassevitch, paragraph 0153).
Regarding claim 5, Monassevitch as modified by Okada teaches that the scope comprises an endoscope (Monassevitch, paragraphs 0039-0040); and wherein the endoscope extends through a second channel (157) extending longitudinally through the shaft (Monassevitch, paragraphs 0153 and 0256).
13. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Monassevitch et al. (US 2010/0331862 A1) (“Monassevitch”) in view of Lau (US 2007/0088203 A1) and Okada (US 4,085,742).
Regarding claim 6, Monassevitch discloses (Figures 1A-1C) a visualization tool (300) configured to allow visualization of an anatomical structure using a scope (endoscope), wherein the visualization tool comprises: an elongated shaft (Figure 1A); a handle (Figure 1C) disposed at a proximal end portion of the shaft. However, Monassevitch fails to disclose that the elongated shaft is substantially malleable. Monassevitch further fails to disclose a scope hood disposed at a distal end portion of the shaft.
Lau teaches that it was known in the art before the effective filing date of the claimed invention for a visualization tool to comprise an elongated, substantially malleable shaft. Lau teaches that a malleable shaft allows the shaft to be flexed or bent, and then retain the shaft in that configuration until such time as an operator decides to further bend or flex, or re-bend or shape the shaft into another configuration (paragraph 0054).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the elongated shaft disclosed by Monassevitch to be substantially malleable, as taught by Lau. This modification will allow the operator to flex and bend the elongated shaft to a desired configuration, and then retain the shaft in that configuration until such time as an operator decides to further bend or flex, or re-bend or shape the shaft into another configuration (Lau, paragraph 0054).
Okada teaches that it was known in the art before the effective filing date of the claimed invention for visualization tools to comprise a scope hood disposed at a distal end portion of the shaft. Okada teaches that a scope hood provides a smooth outer surface to prevent injury to the inner surface of a body cavity and prevents a foreign substance from being excessively deposited onto the front end surface endoscope (Column 1, lines 21-30).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the visualization tool taught by Monassevitch in view of Lau to comprise a scope hood disposed at a distal end portion of the shaft, as taught by Okada. This modification would provide a smooth outer surface to prevent injury to the inner surface of a body cavity and would prevent a foreign substance from being excessively deposited onto the front end surface endoscope (Okada, Column 1, lines 21-30).
Claims 11, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Sugarbaker (5,766,187) in view of Davis (US 3,856,016) as applied to claims 10 and 22 respectively, above, and further in view of Beardsley et al. (US 2012/0143218 A1) (“Beardsley”).
Regarding claim 11, Sugarbaker as modified by Davis teaches that the clip applier comprises a first jaw and a second jaw, at least one of the first jaw and the second jaw being articulable to open and close the occlusion clip. However, the combined teaching fails to teach that the first jaw comprises a jaw member and the distal tip portion, the distal tip portion being releasably attached to the jaw member.
Beardsley teaches (Figures 25-27) a jaw member (28) with a distal tip portion (600’), the distal tip portion being releasably attached to the jaw member and releasably attachable to an introducer (700, paragraphs 0140-0144).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first jaw to comprise a jaw member and the distal tip portion, the distal tip portion being releasably attached to the jaw member, as taught by Beardsley. This modification would provide a detachable tip that when attached, facilitates separation of target tissue from any collateral tissue during the procedure (paragraph 0144).
Regarding claims 23 and 24, Sugarbaker as modified by Davis teaches the invention substantially as claimed. However, the combined teaching fails to teach that one of the first connector and the second connector comprises a latch disposed on an elastically deformable arm; wherein the other of the first connector and the second connector comprises a flange; and wherein, when the first connector and the second connector are connected, the latch engages the flange to prevent the first connector and the second connector from separating.
Beardsley teaches (Figures 20, 21) an end effector (28) comprising a distal tip portion that is configured to connected to a distal end portion of an introducer (500). Beardsley teaches that the distal end portion of the introducer comprises a first connector, the distal tip portion of the end effector comprises a second connector, and the first connector and the second connector are releasably connectable. Beardsley teaches that one of the first connector and the second connector comprises a latch (512) disposed on an elastically deformable arm (506, 508); wherein the other of the first connector and the second connector comprises a flange; and wherein, when the first connector and the second connector are connected, the latch engages the flange to prevent the first connector and the second connector from separating (paragraph 0136).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the connector configuration taught by Beardsley for the connector configuration taught by Sugarbaker in view of Davis. Substitution of one known element (the connector configuration taught by Beardsley) for another element (the connector configuration taught by Sugarbaker in view of Davis) providing the same function (releasably connecting the introducer to the distal tip of the end effector) to yield predictable results (separating target tissue from collateral tissue) would have been obvious to one of ordinary skill in the art at the time of the invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sugarbaker (5,766,187) in view of Davis (US 3,856,016) as applied to claim 15 above, and in further view of Noyes (US 2016/0106300 A1).
Regarding claim 16, Sugarbaker in view of Davis teaches the invention substantially as claimed. However, the combined teaching fails to teach that the shaft is substantially malleable.
Noyes teaches (Figures 2-6) an analogous surgical device comprising an elongate shaft (118) that is substantially malleable to allow adjustment of the shaft to various angles prior or subsequent to insertion for easier insertion and/or manipulation (paragraph 0039).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft taught by Sugarbaker in view of Davis to be substantially malleable, as taught by Noyes. This modification would allow adjustment of the shaft to various angles prior or subsequent to insertion for easier insertion and/or manipulation (Noyes, paragraph 0039).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sugarbaker (5,766,187) in view of Davis (US 3,856,016) as applied to claim 12 above, and further in view of Morriss et al. (US 2015/0250992 A1) (“Morriss”)
Regarding claim 17 Sugarbaker as modified by Davis teaches the invention substantially as claimed. However, the combined teaching fails to teach that the shaft comprises a generally flexible inner shaft and a generally malleable outer shaft; wherein the outer shaft is substantially shorter than the inner shaft; and wherein the outer shaft is axially slidably disposed on the inner shaft.
Morriss teaches (Figures 6A-6D) a medical device with a shaft that comprises a generally flexible inner shaft (100) and a generally malleable outer shaft (92), wherein the outer shaft is substantially shorter than the inner shaft, and wherein the outer shaft is axially slidably disposed on the inner shaft (Figures 6C-6D; paragraph 0077).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft taught by Sugarbaker in view of Davis to comprise a generally flexible inner shaft and a generally malleable outer shaft, wherein the outer shaft is substantially shorter than the inner shaft, and wherein the outer shaft is axially slidably disposed on the inner shaft, as taught by Morriss. This modification will allow the operator to bend the outer shaft to a desired orientation while still allowing the end effector to be actuated (Morriss, paragraph 0077).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Bayer (US 2004/0204725 A1) discloses a similar system capable of applying an occlusion clip to an anatomical structure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
