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 .
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) 16-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0080440 A1 to Durgin et al. (hereinafter “Durgin”) in view of US 2008/0306491 A1 to Cohen et al. (hereinafter “Cohen”).
Regarding claim 16, Durgin discloses (see abstract; Figs. 1-43; and [0050]-[0111]) a clipping system for treating tissue (see at least [0050]), comprising: an applicator (100) including a flexible elongate member (104) extending from a proximal end (102) which, during use, remains outside a living body to a distal end which, during use, is inserted into the living body to a location adjacent to target tissue to be clipped (see Figs. 1-2 and [0050]-[0054]), the applicator including: a control member (118) extending through the applicator (see Fig. 9 and [0053]); and a bushing (202 or 806) coupled to a distal end of the elongate flexible member (see Fig. 9), the bushing including a proximal body (e.g., as shown in 22, indicated by #202) coupled to a distal end of the flexible elongate member (see Fig. 9) and a distal coupling (350) (see Fig. 21); a clip (90) including a capsule (200) releasably coupled to the distal coupling of the bushing via a first coupling member of the capsule (306) hooked over a corresponding first hook (350) of the distal coupling of the bushing (see [0066]/[0072]), the capsule including a channel extending therethrough (as shown in Fig. 12), and a pair of clip arms (208), proximal ends of which are slidably received within the channel for movement between an open configuration (Fig. 12), in which distal ends of the clip arms are separated from one another to receive tissue therebetween, and a closed configuration (Fig. 10), in which the distal ends of the clip arms are drawn toward one another to grip tissue (see [0065]-[0069]), and a core member (204 + 206) received between and connected to the proximal ends of the clip arms (see Fig. 12) and including a first lateral projection (cam surfaces of yoke 204 as per [0072]) and a first failure point distal of the first lateral projection (at 214 + 216, see Fig. 9 and [0066]-[0071]) , the first failure point separating a distal portion (206) of the core member from a proximal portion (204) thereof (see Fig. 9 and [0066]-[0071]), the core member being coupled to a distal end (140) of the control member (see Figs. 9-10) so that longitudinal movement of the control member relative to the elongate flexible member moves the clip arms between the open configuration and the closed configuration (see [0065]-[0068]), a lateral extent of the first lateral projection being selected so that, when the clip is clipped over target tissue, the first lateral projection is drawn proximally (see [0071]-[0074]), the first lateral projection driving the first coupling member radially outward beyond an outer end of the first hook to free the capsule from the bushing (see [0071]-[0074] and Fig. 24).
Durgin further discloses (claim 17) wherein the core member includes a first pin (402) received within a hole (400) in a proximal part of a first one of the clip arms and a second pin (402) received within a hole (400) in a proximal part of a second one of the clip arms (see Figs. 18/26 and [0079]/[0094]); (claim 19) wherein the proximal body of the bushing includes a proximal section having an outer diameter substantially equal to an outer diameter of the flexible elongate member and a distal section of the proximal body of the bushing has an outer diameter substantially equal to an outer diameter of the capsule (see Figs. 9-10); and (claim 20) wherein an inner diameter of the channel is substantially equal to an inner diameter of a distal section of the proximal body of the bushing (see Figs. 9-10);
Regarding claim 16, Durgin fails to specifically disclose a distal coupling movably attached to the proximal body, and wherein drawing the first lateral projection proximally moves the distal coupling into the proximal body of the bushing. Further, with respect to claim 18, Durgin fails to specifically disclose wherein the distal coupling is slidably coupled to the proximal body of the bushing for movement proximally and distally into and out of a distal end of the proximal body. Cohen discloses, in the same field of endeavor, a clipping system comprising a capsule (110) and a bushing (120 + 154), wherein the bushing comprises a proximal body (120, Fig. 8) coupled to a distal end of an flexible elongate member (130, Figs. 1/7) and a distal coupling (bushing support 154) movably attached to the proximal body for movement proximally and distally into and out of the proximal body (see Figs. 708 and [0066]-[0068]) for the purpose of providing a mechanism which helps push tabs radially outward to maintain a locked state between the bushing and the capsule until the distal coupling moves proximally into the proximal body of the bushing to detach the bushing and the capsule (see [0066]-[0068]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Durgin with the bushing support as taught by Cohen in order to help assist the connection between the capsule and the bushing by providing a mechanism which helps push tabs radially outward to maintain a locked state between the bushing and the capsule until the distal coupling moves proximally into the proximal body of the bushing to detach the bushing and the capsule.
With respect to claim 21, the combination of Durgin and Cohen, as discussed above for the reasons set forth above, would disclose wherein the lateral extent of the first lateral projection is selected to be substantially equal to the inner diameters of the channel and the distal section of the proximal body of the bushing and wherein a proximal portion of the distal coupling has an inner diameter slightly smaller than that of the channel and the distal section of the proximal body of the bushing so that the first lateral projection becomes lodged against the distal coupling within the bushing (see [0066]-[0068] of Cohen as applied to [0071]-[0074] and Fig. 24 of Durgin).
With respect to claim 22, the combination of Durgin and Cohen, as discussed above for the reasons set forth above, would disclose (as per Durgin) wherein the core member includes a second failure point (at 210) proximal of the first failure point (see Figs. 9-10), the core member defining the distal portion distal of the first failure point, a medial portion between the first and second failure points and the proximal section proximal of the second failure point (see Figs. 9-10).
With respect to claim 23, the combination of Durgin and Cohen, as discussed above for the reasons set forth above, would disclose (as per Durgin) wherein the clip arms are constructed to define a proximal-most position of the clip arms within the capsule so that, when a proximally tension applied to the control member after the clip arms have reached the proximal-most position exceeds a first threshold level, the core member separates at the first failure point permitting the medial and proximal portions of the core member to move proximally drawing the first lateral projection proximally out of the capsule (see Figs. 16/17/24 and [0069]-[0074]) driving the first coupling member of the capsule radially outward beyond an outer end of the first hook of the distal coupling of the bushing to separate the capsule from the bushing (see [0069]-[0074])
Regarding claim 24, Durgin discloses (see abstract; Figs. 1-43; and [0050]-[0111]) a device for clipping tissue (see at least [0050]), comprising: a bushing (202 or 806) including a proximal body (e.g., as shown in 22, indicated by #202) configured to be coupled to a distal end of a flexible applicator (104) (see Fig. 9) and a distal coupling (350) (see Fig. 21), the distal coupling including a first hook (350) (see [0066]/[0072]); a clip (90) including a capsule (200) releasably coupled to the distal coupling via a first coupling member (306) of the capsule hooked over the first hook (see [0066]/[0072]), the capsule including a channel extending therethrough (as shown in Fig. 12), and a pair of clip arms (208), proximal ends of which are slidably received within the channel for movement between an open configuration (Fig. 12), in which distal ends of the clip arms are separated from one another to receive tissue therebetween, and a closed configuration (Fig. 10), in which the distal ends of the clip arms are drawn toward one another to grip tissue (see [0065]-[0069]), and a core member (204 + 206) received between and connected to the proximal ends of the clip arms (see Fig. 12) and including a first lateral projection (cam surfaces of yoke 204 as per [0072]) and a first failure point distal of the first lateral projection (at 214 + 216, see Fig. 9 and [0066]-[0071]) , the first failure point separating a distal portion (206) of the core member from a proximal portion (204) thereof (see Fig. 9 and [0066]-[0071]), the core member being coupled to a distal end (140) of the control member (see Figs. 9-10) so that longitudinal movement of the control member relative to the elongate flexible member moves the clip arms between the open configuration and the closed configuration (see [0065]-[0068]), a lateral extent of the first lateral projection being selected so that, when the clip is clipped over target tissue, the first lateral projection is drawn proximally (see [0071]-[0074]), the first lateral projection driving the first coupling member radially outward beyond an outer end of the first hook to free the capsule from the bushing (see [0071]-[0074] and Fig. 24).
Durgin further discloses (claim 25) wherein the core member includes a first pin (402) received within a hole (400) in a proximal part of a first one of the clip arms and a second pin (402) received within a hole (400) in a proximal part of a second one of the clip arms (see Figs. 18/26 and [0079]/[0094]); (claim 27) wherein the proximal body of the bushing includes a proximal section having an outer diameter substantially equal to an outer diameter of the flexible elongate member and a distal section of the proximal body of the bushing has an outer diameter substantially equal to an outer diameter of the capsule (see Figs. 9-10); and (claim 28) wherein an inner diameter of the channel is substantially equal to an inner diameter of a distal section of the proximal body of the bushing (see Figs. 9-10).
Regarding claim 24, Durgin fails to specifically disclose a distal coupling movably attached to the proximal body, and wherein drawing the first lateral projection proximally moves the distal coupling into the proximal body of the bushing. Further, with respect to claim 26, Durgin fails to specifically disclose wherein the distal coupling is slidably coupled to the proximal body of the bushing for movement proximally and distally into and out of a distal end of the proximal body. Cohen discloses, in the same field of endeavor, a clipping system comprising a capsule (110) and a bushing (120 + 154), wherein the bushing comprises a proximal body (120, Fig. 8) coupled to a distal end of an flexible elongate member (130, Figs. 1/7) and a distal coupling (bushing support 154) movably attached to the proximal body for movement proximally and distally into and out of the proximal body (see Figs. 708 and [0066]-[0068]) for the purpose of providing a mechanism which helps push tabs radially outward to maintain a locked state between the bushing and the capsule until the distal coupling moves proximally into the proximal body of the bushing to detach the bushing and the capsule (see [0066]-[0068]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Durgin with the bushing support as taught by Cohen in order to help assist the connection between the capsule and the bushing by providing a mechanism which helps push tabs radially outward to maintain a locked state between the bushing and the capsule until the distal coupling moves proximally into the proximal body of the bushing to detach the bushing and the capsule.
With respect to claim 29, the combination of Durgin and Cohen, as discussed above for the reasons set forth above, would disclose wherein the lateral extent of the first lateral projection is selected to be substantially equal to the inner diameters of the channel and the distal section of the proximal body of the bushing and wherein a proximal portion of the distal coupling has an inner diameter slightly smaller than that of the channel and the distal section of the proximal body of the bushing so that the first lateral projection becomes lodged against the distal coupling within the bushing (see [0066]-[0068] of Cohen as applied to [0071]-[0074] and Fig. 24 of Durgin).
With respect to claim 30, the combination of Durgin and Cohen, as discussed above for the reasons set forth above, would disclose (as per Durgin) wherein the core member includes a second failure point (at 210) proximal of the first failure point (see Figs. 9-10), the core member defining the distal portion distal of the first failure point, a medial portion between the first and second failure points and the proximal section proximal of the second failure point (see Figs. 9-10).
Regarding claim 31, Durgin discloses (see abstract; Figs. 1-43; and [0050]-[0111]) a method for clipping tissue (see at least [0050]), comprising: inserting into a living body to a location adjacent to target tissue to be clipped a distal portion of a flexible elongate member (104) while maintaining a proximal end of the flexible elongate member outside the living body (see Figs. 1-2 and [0050]-[0054]), wherein a control member (118) extends through an applicator (100) and a bushing (202 or 806) coupled to a distal end of the elongate flexible member (see Fig. 9), includes a proximal body (e.g., as shown in 22, indicated by #202) coupled to a distal end of the flexible elongate member (see Fig. 9) and a distal coupling (350) (see Fig. 21); positioning a clip (90) coupled to the bushing adjacent to the target tissue (see [0051]), the clip including a capsule (200) releasably coupled to the distal coupling of the bushing via a first coupling member (306) of the capsule hooked over a corresponding first hook (350) of the distal coupling of the bushing (see [0066]/[0072]), the capsule including a channel extending therethrough (as shown in Fig. 12), and a pair of clip arms (208), proximal ends of which are slidably received within the channel (see Fig. 12); moving the control member distally relative to the elongate flexible member to move the clip arms to an open configuration (Fig. 12), in which distal ends of the clip arms are separated from one another to receive tissue therebetween (see Fig. 12 and [0065]-[0069]); drawing the control member proximally relative to the elongate flexible member to move the clip arms to a closed configuration (Fig. 16), in which the distal ends of the clip arms are drawn toward one another so that the target tissue is gripped by the clip arm (see [0065]-[0069]); drawing the control member further proximally to increase a tension applied to a core member coupled to a distal end of the control member and received between and connected to the proximal ends of the clip arms until the tension reaches a predetermined level at which a distal portion (206) of the core member is separated from a proximal portion (204) thereof (see Figs. 16-17 and [0069]-[0071]); wherein a lateral extent of the first lateral projection of the proximal portion of the core member being selected so that, when the distal portion of the core member is separated from the proximal portion of the core member, the first lateral projection is drawn proximally (see [0069]-[0074]), the first lateral projection driving the first coupling member radially outward beyond an outer end of the first hook to free the capsule from the bushing (see [0071]-[0074] and Fig. 24).
Durgin further discloses (claim 33) wherein an inner diameter of the channel is substantially equal to an inner diameter of a distal section of the proximal body of the bushing (see Figs. 9-10).
Regarding claim 31, Durgin fails to specifically disclose a distal coupling movably attached to the proximal body, and wherein drawing the first lateral projection proximally moves the distal coupling into the proximal body of the bushing. Further, with respect to claim 32, Durgin fails to specifically disclose wherein the distal coupling is slidably coupled to the proximal body of the bushing for movement proximally and distally into and out of a distal end of the proximal body. Cohen discloses, in the same field of endeavor, a clipping system comprising a capsule (110) and a bushing (120 + 154), wherein the bushing comprises a proximal body (120, Fig. 8) coupled to a distal end of an flexible elongate member (130, Figs. 1/7) and a distal coupling (bushing support 154) movably attached to the proximal body for movement proximally and distally into and out of the proximal body (see Figs. 708 and [0066]-[0068]) for the purpose of providing a mechanism which helps push tabs radially outward to maintain a locked state between the bushing and the capsule until the distal coupling moves proximally into the proximal body of the bushing to detach the bushing and the capsule (see [0066]-[0068]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Durgin with the bushing support as taught by Cohen in order to help assist the connection between the capsule and the bushing by providing a mechanism which helps push tabs radially outward to maintain a locked state between the bushing and the capsule until the distal coupling moves proximally into the proximal body of the bushing to detach the bushing and the capsule.
With respect to claim 34, the combination of Durgin and Cohen, as discussed above for the reasons set forth above, would disclose wherein the lateral extent of the first lateral projection is selected to be substantially equal to the inner diameters of the channel and the distal section of the proximal body of the bushing and wherein a proximal portion of the distal coupling has an inner diameter slightly smaller than that of the channel and the distal section of the proximal body of the bushing so that the first lateral projection becomes lodged against the distal coupling within the bushing (see [0066]-[0068] of Cohen as applied to [0071]-[0074] and Fig. 24 of Durgin).
With respect to claim 35, the combination of Durgin and Cohen, as discussed above for the reasons set forth above, would disclose (as per Durgin) wherein the core member includes a second failure point (at 210) proximal of the first failure point (see Figs. 9-10), the core member defining the distal portion distal of the first failure point, a medial portion between the first and second failure points and the proximal section proximal of the second failure point (see Figs. 9-10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing clipping systems comprising a bushing and a capsule which allows for detachment of the clip from the delivery instrument.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771