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
In response to the amendment filed on 08/26/2024, No Claims have been cancelled, and Claims 1-21 are pending.
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 1-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,004,937 (now referred to as Pat ‘937). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Present Claim 1, Claim 1 of Pat ‘937 teaches an apparatus for delivering a surgical mesh (Column 14, Lines 33-34), the apparatus comprising:
a hollow outer tube having a distal end and a proximal end (Column 14, Lines 35-36);
a distal housing mounted to the distal end of the hollow outer tube (Column 14, Lines 37-38);
a hollow inner tube having a distal end and a proximal end, wherein the hollow inner tube is slidably disposed within the hollow outer tube (Column 14, Lines 39-41);
a central rod having a distal end and a proximal end, wherein the central rod is slidably disposed within the hollow inner tube (Column 14, Lines 42-44);
an actuation element (member) mounted to the proximal end of the central rod (Column 14, Lines 45-46); and
a surgical mesh carriage comprising a plurality of legs, wherein each of the plurality of legs comprises a first hinged end mounted to the distal end of the hollow inner tube and a second hinged end mounted to the distal end of the central rod (Column 14, Lines 47-51).
Regarding Present Claim 2, Claim 2 of Pat ‘937 teaches the apparatus according to claim 1 wherein the apparatus is configured such that when (i) the actuation element is moved distally to a first location, the central rod and the hollow inner tube move distally so as to move the surgical mesh carriage out of the distal housing, and (ii) the actuation element is moved distally to a second location the central rod moves distally and hinges each of the plurality of legs at their respective first hinged ends so that the plurality of legs assume a radially-expanded configuration.
Regarding Present Claim 3, Claim 3 of Pat ‘937 teaches the apparatus according to claim 2 wherein tactile feedback is provided to a user when the actuation element reaches the first location.
Regarding Present Claim 4, Claim 4 of Pat ‘937 teaches the apparatus according to claim 2 wherein audible feedback is provided to a user when the actuation element reaches the second location.
Regarding Present Claim 5, Claim 9 of Pat ‘937 teaches the apparatus according to claim 1 wherein each of the plurality of legs further comprises a flexible connection disposed between the first hinged end and the second hinged end.
Regarding Present Claim 6, Claim 10 of Pat ‘937 teaches the apparatus according to claim 5 wherein each of the plurality of legs comprises a first portion disposed between the first hinged end and the flexible connection, and a second portion disposed between the flexible connection and the second hinged end, and further wherein the first portion is disposed parallel with the second portion.
Regarding Present Claim 7, Claim 11 of Pat ‘937 teaches the apparatus according to claim 1 wherein the second hinged ends of the plurality of legs are formed integral with each other so as to form a base having a central opening mounted to the distal end of the central rod.
Regarding Present Claim 8, Claim 12 of Pat ’937 teaches the apparatus according to claim 7 wherein the distal end of the central rod comprises a plug with a distal portion having a diameter wider than the diameter of the central opening.
Regarding Present Claim 9, Claim 5 of Pat ‘937 teaches the apparatus according to claim 2 wherein when the plurality of legs are in the radially-expanded configuration, the plurality of legs are disposed generally perpendicular to the longitudinal axis of the hollow outer tube.
Regarding Present Claim 10, Claim 1 of Pat ‘937 teaches the apparatus according to claim 1 wherein the distal housing comprises a proximal mount fixedly mounted to the distal end of the hollow outer tube and an atraumatic distal shroud (Column 14, Lines 53-54).
Regarding Present Claim 11, Claim 13 of Pat ‘937 teaches the apparatus according to claim 10 wherein the atraumatic distal shroud is formed out of an elastic material.
Regarding Present Claim 12, Claim 14 of Pat ‘937 teaches the apparatus according to claim 11 wherein the elastic material comprises silicone.
Regarding Present Claim 13, Claim 1 of Pat ‘937 teaches the apparatus according to claim 10 wherein the atraumatic distal shroud comprises a cone-shaped tip (Column 14, Lines 55).
Regarding Present Claim 14, Claim 15 of Pat ‘937 teaches the apparatus according to claim 13 wherein the cone-shaped tip comprises at least four flexible leaflets.
Regarding Present Claim 15, Claim 6 of Pat ‘937 teaches the apparatus according to claim 2 further comprising a handle mounted to the proximal end of the hollow outer tube.
Regarding Present Claim 16, Claim 7 of Pat ‘937 teaches the apparatus according to claim 15 wherein the proximal end of the hollow inner tube comprises a locking collar and the handle comprises a locking tab, and further wherein the locking collar is configured to mate with the locking tab.
Regarding Present Claim 17, Claim 8 of Pat ‘937 teaches the apparatus according to claim 16 wherein the locking collar snaps over the locking tab so as to provide audible feedback to a user indicating that the plurality of legs are in the radially-expanded configuration.
Regarding Present Claim 18, Claim 16 of Pat ‘937 teaches the apparatus according to claim 1 wherein the distal end of the hollow inner tube comprises a collar and further wherein the first hinged ends of each of the plurality of legs are received in a plurality of seats formed in the collar.
Regarding Present Claim 19, Claim 17 of Pat ‘937 teaches the apparatus according to claim 18 wherein a locking ring is mounted over the first hinged ends of the plurality of legs in the plurality of seats formed in the collar.
Regarding Present Claim 20, Claim 18 of Pat ‘937 teaches a method for delivering a surgical mesh, the method comprising (Column 15, Lines 51-52):
providing apparatus for delivering a surgical mesh, the apparatus comprising (Column 15, Lines 53-54):
a hollow outer tube having a distal end and a proximal end (Column 15, Lines 55-56);
a distal housing mounted to the distal end of the hollow outer tube (Column 15, Lines 57-58);
a hollow inner tube having a distal end and a proximal end, wherein the hollow inner tube is slidably disposed within the hollow outer tube (Column 15, Lines 59-61);
a central rod having a distal end and a proximal end, wherein the central rod is slidably disposed within the hollow inner tube (Column 15, Lines 62-64);
an actuation element mounted to the proximal end of the central rod (Column 15, Lines 65-66); and
a surgical mesh carriage comprising a plurality of legs, wherein each of the plurality of legs comprises a first hinged end mounted to the distal end of the hollow inner tube and a second hinged end mounted to the distal end of the central rod (Column 16, Lines 1-5);
advancing the apparatus through an incision to a surgical site (Column 16, Lines 11-12);
moving the actuation element distally to a first location, whereby to project the surgical mesh carriage out of the distal housing (Column 16, Lines 13-15);
moving the actuation element distally to a second location, whereby to hinge each of the plurality of legs at their respective first hinged ends and cause the plurality of legs to assume a radially-expanded configuration (Column 16, Lines 14-20); and
delivering a surgical mesh to the surgical site (Column 16, Lines 21).
Regarding Present Claim 21, Claim 19 of Pat ‘937 discloses an apparatus for delivering a surgical mesh, the apparatus comprising (Column 16, Lines 22-23):
a hollow outer tube having a distal end and a proximal end (Column 16, Lines 25-26);
a distal housing mounted to the distal end of the hollow outer tube (Column 16, Lines 27-28);
a hollow inner tube slidably disposed within the hollow outer tube having a distal end and a proximal end, wherein the proximal end of the hollow inner tube comprises a locking collar (Column 16, Lines 29-32);
a central rod having a distal end and a proximal end, wherein the central rod is slidably disposed within the hollow inner tube (Column 16, Lines 34-36);
an actuation element mounted to the proximal end of the central rod (Column 16, Lines 37-38);
a surgical mesh carriage comprising a plurality of legs, wherein each of the plurality of legs comprises a first hinged end mounted to the distal end of the hollow inner tube and a second hinged end mounted to the distal end of the central rod (Column 16, Lines 39-43); and
a handle comprising a locking tab mounted to the proximal end of the hollow outer tube (Column 16, Lines 45-46);
wherein the apparatus is configured such that when (i) the actuation element is moved distally to a first location, the central rod and the hollow inner tube move distally so as to move the surgical mesh carriage out of the distal housing, and (ii) the actuation element is moved distally to a second location the central rod moves distally and hinges each of the plurality of legs at their respective first hinged ends so as to assume a radially-expanded configuration (Column 17, Lines 51-59); and
wherein distal movement of the actuation element to the second location causes the locking collar to audibly snap over the locking tab so as to provide feedback to a user indicating that the plurality of legs are in the radially-expanded configuration (Column 17, Lines 61-65).
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.
Claim(s) 1, 5, 6, 10-14, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kammerer (US Patent 5,397,332) in view of Zenz-Olson (US PGPub 2016/0324616).
Regarding Claim 1, Kammerer teaches an apparatus (50) for delivering a surgical mesh, the apparatus comprising:
a hollow outer tube (100) having a distal end (furthest from user) and a proximal end (at element 150) (see Figure 23 for outer tube separated from the other elements);
a distal housing formed by the distal end of the hollow outer tube (see Figures 2-3 and Figures 5 where the distal end of outer tube 100 houses the carriage (62) and mesh (65) in an undeployed configuration)
a hollow inner tube (102) having a distal end (furthest from user) and a proximal end (closest to user which ends near element 130; Figure 2 and Figure 22-23), wherein the hollow inner tube (102) is slidably disposed within the hollow outer tube (100; Figures 3-4, 22-23; Column 5, Lines 64-67 and Column 6, Lines 1-10);
a central rod (106) having a distal end (connected to element 90; Figures 22-23) and a proximal end (connected to element 105; Figures 5-6), wherein the central rod (106) is slidably disposed within the hollow inner tube (102; Column 6, Lines 11-21);
an actuation element (130) mounted to the proximal end of the central rod (106; Figure 5; Columns 6, Lines 60-67); and
a surgical mesh carriage (60; Figure 6) comprising a plurality of legs (62; Figure 6), wherein each of the plurality of legs (62) comprises a first hinged end (at element 64) mounted to the distal end of the hollow inner tube (102; Figure 6) and a second hinged end (at element 66; Figure 6) mounted to the distal end of the central rod (106; Figure 6).
Kammerer fails to disclose:
a distal housing mounted to the distal end of the hollow outer tube.
Zenz-Olson teaches a medical implant delivery system (abstract) comprising an a hollow outer tube (101) and a hollow inner tube (103) slidably disposed within the hollow outer tube (101), wherein the hollow inner tube (103) is configured to deploy an expandable surgical mesh carriage (107; Paragraph 0050) carrying a sheet-like implant (see Figure 16B) , wherein a distal housing (105) mounted to the distal end of the outer tube (101; Figures 1, 5, 16A-16B) to “make it easier for a user to insert the implant delivery system 100 into a patient, for example by allowing use of the implant delivery system 100 without an obturator” (Paragraph 0073; Zenz-Olson).
It would have been obvious to one of ordinary skill in the art to modify the teachings of Kammerer such that a flexible distal housing is mounted to the distal end of the outer tube, as taught by Zenz-Olson, for the advantage that as the implant delivery system is inserted, the distal housing is configured to collapse into itself due to outside forces and thus close the distal end of the outer tube such that tissue is prevented from entering the lumen, however the distal housing is still flexible enough such that when the surgical mesh carriage is pushed through the distal housing, the distal housing expands to allow the surgical mesh carriage to be deployed (Paragraph 0073 and Paragraph 0075-0077; Zenz-Olson).
Regarding Claim 5, the combination teaches the apparatus according to claim 1 wherein Kammerer teaches each of the plurality of legs (62) further comprises a flexible connection (69; Figure 6; midpoint in which the legs flex) disposed between the first hinged end (64; Figure 6) and the second hinged end (66; Figure 6).
Regarding Claim 6, the combination of references disclosed above teaches the apparatus according to claim 5 wherein Kammerer teaches each of the plurality of legs (62) comprises a first portion disposed between the first hinged end (64) and the flexible connection (69), and a second portion disposed between the flexible connection (69) and the second hinged end (66), and further wherein the first portion is disposed parallel with the second portion (as seen in Figures 1, 3, and 5; Column 8, Lines 18-20).
Regarding Claim 10, the combination of references disclosed above teaches the apparatus according to claim 1 wherein Zenz-Olson teaches the distal housing (105; Figure 1) comprises a proximal mount (Paragraph 0073) fixedly mounted to the distal end of the hollow outer tube (101) and an atraumatic distal shroud (Paragraph 0077 discloses that shroud 105 flexes in response to forces on the outside of the petals).
Regarding Claim 11, the combination of references disclosed above teaches the apparatus according to claim 10 wherein Zenz-Olson teaches the atraumatic distal shroud is formed out of an elastic material (Paragraph 0077 discloses that shroud 105 flexes in response to forces on the outside of the petals and thus would inherently be elastic if the forces do not cause plastic deformation, see also Paragraph 0080).
Regarding Claim 12, the combination of references disclosed above teaches the apparatus according to claim 11 wherein Zenz-Olson teaches the elastic material comprises silicone (Paragraph 0080).
Regarding Claim 13, the combination of references disclosed above teaches the apparatus according to claim 10 wherein Zenz-Olson teaches the atraumatic distal shroud (105) comprises a cone-shaped tip (Figure 1 and Figure 5).
Regarding Claim 14, the combination of references disclosed above teaches the apparatus according to claim 13 wherein Zenz-Olson teaches the cone-shaped tip (105) comprises at least four flexible leaflets (161; Figure 1 and Figure 5; Paragraph 0074).
Regarding Claim 18, the combination of references disclosed above teaches the apparatus according to claim 1 wherein Kammerer teaches the distal end of the hollow inner tube (103) comprises a collar (64; Figure 10; Column 8, Lines 36-55) and further wherein the first hinged ends (68) of each of the plurality of legs (62) are received in a plurality of seats (74/75) formed in the collar (64; Column 8, Lines 36-55).
Regarding Claim 19, the combination of references disclosed above teaches the apparatus according to claim 18 wherein Kammerer teaches a locking ring (73) is mounted over the first hinged ends (68) of the plurality of legs (62) in the plurality of seats (74/75) formed in the collar (65; see Figure 10).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kammerer (US Patent 5,397,332) in view of Zenz-Olson (US PGPub 2016/0324616) and Johnson (US Patent 3,857,395).
Regarding Claim 20, Kammerer teaches a method for delivering a surgical mesh (Column 10, Lines 1-23), the method comprising:
providing apparatus (50) for delivering a surgical mesh (65) (Column 9, Lines 45-67), the apparatus comprising:
a hollow outer tube (100) having a distal end (furthest from user) and a proximal end (at element 150) (see Figure 23 for outer tube separated from the other elements);
a distal housing formed by the distal end of the hollow outer tube (see Figures 2-3 and Figures 5 where the distal end of outer tube 100 houses the carriage (62) and mesh (65) in an undeployed configuration)
a hollow inner tube (102) having a distal end (furthest from user) and a proximal end (closest to user which ends near element 130; Figure 2 and Figure 22-23), wherein the hollow inner tube (102) is slidably disposed within the hollow outer tube (100; Figures 3-4, 22-23; Column 5, Lines 64-67 and Column 6, Lines 1-10);
a central rod (106) having a distal end (connected to element 90; Figures 22-23) and a proximal end (connected to element 105; Figures 5-6), wherein the central rod (106) is slidably disposed within the hollow inner tube (102; Column 6, Lines 11-21);
an actuation element (130) mounted to the proximal end of the central rod (106; Figure 5; Columns 6, Lines 60-67); and
a surgical mesh carriage (60; Figure 6) comprising a plurality of legs (62; Figure 6), wherein each of the plurality of legs (62) comprises a first hinged end (at element 64) mounted to the distal end of the hollow inner tube (102; Figure 6) and a second hinged end (at element 66; Figure 6) mounted to the distal end of the central rod (106; Figure 6).
advancing the apparatus (50) through an incision to a surgical site (Column 10, Lines 1-4);
moving the actuation element (130) distally to a first location, whereby to project the surgical mesh carriage (30) out of the distal housing (Figures 5-6. The actuation element is moved distally relative to the outer sheath (100; Column 10, Lines 12-21);
moving the actuation element (130) proximally to a second location (relative to the outer tube and inner tube), whereby to hinge each of the plurality of legs (62) at their respective first hinged ends (see Figure 7) and cause the plurality of legs to assume a radially-expanded configuration (as seen in Figure 7; Column 10, Lines 27-31); and
delivering a surgical mesh (65) to the surgical site.
Kammerer fails to disclose:
a distal housing mounted to the distal end of the hollow outer tube.
Zenz-Olson teaches a medical implant delivery system (abstract) comprising an a hollow outer tube (101) and a hollow inner tube (103) slidably disposed within the hollow outer tube (101), wherein the hollow inner tube (103) is configured to deploy an expandable surgical mesh carriage (107; Paragraph 0050) carrying a sheet-like implant (see Figure 16B) , wherein a distal housing (105) mounted to the distal end of the outer tube (101; Figures 1, 5, 16A-16B) to “make it easier for a user to insert the implant delivery system 100 into a patient, for example by allowing use of the implant delivery system 100 without an obturator” (Paragraph 0073; Zenz-Olson).
It would have been obvious to one of ordinary skill in the art to modify the teachings of Kammerer such that a flexible distal housing is mounted to the distal end of the outer tube, as taught by Zenz-Olson, for the advantage that as the implant delivery system is inserted, the distal housing is configured to collapse into itself due to outside forces and thus close the distal end of the outer tube such that tissue is prevented from entering the lumen, however the distal housing is still flexible enough such that when the surgical mesh carriage is pushed through the distal housing, the distal housing expands to allow the surgical mesh carriage to be deployed (Paragraph 0073 and Paragraph 0075-0077; Zenz-Olson).
The combination further fails to disclose:
moving the actuation element distally to a second location, whereby to hinge each of the plurality of legs at their respective first hinged ends and cause the plurality of legs to assume a radially-expanded configuration.
Johnson teaches an inserter device for delivering a medical device (tampon) comprising an outer tube (13/10; Figures 1-2), a central rod (12; Figures 1-2) slidably disposed within the outer tube (13), an actuation element (18) mounted to the proximal end of the central rod (12), and a surgical mesh carriage comprising a plurality of legs (11) with a hinge (22) disposed between the proximal and distal ends of each of the plurality of legs (11) (Column 5, Lines 36-62), wherein moving the actuation element (18) distally (as seen in Figure 2) hinges each of the plurality of legs at their respective first hinged ends (20; Figure 2) and cause the plurality of legs (11) to assume a radially-expanded configuration (as seen in Figure 2).
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute actuation mechanism taught by Kammerer with distally advanceable actuation mechanism as taught by Johnson since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the Johnson reference only teaches a mechanism to deploy hinged legs outwardly in response to distal movement of the actuator, and this mechanism of Johnson would be sufficient to expand the legs taught by Kammerer since both devices are designed to deploy a sheet-like medical device into the body from a delivery configuration (Figure 1) to a deployed expanded configuration (Figure 2). Furthermore, the “moving the actuation element distally to a second location” limitation only applies to a second location once the surgical mesh carriage/legs are deployed out of the outer tube taught by Kammerer, therefore the combination of references would read on the claims because Johnson teaches moving the actuator distally to the second position only to actuate the legs in an expanded position.
Claim(s) 2, 3, 9, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kammerer (US Patent 5,397,332) in view of Zenz-Olson (US PGPub 2016/0324616) as applied to claim 1 above, and further in view of Johnson (US Patent 3,857,395)
Regarding Claim 2, the combination of references disclosed above teaches the apparatus according to claim 1 wherein Kammerer teaches the apparatus is configured such that when (i) the actuation element (130) is moved distally to a first location (relative to the outer sheath; see Figures 5-6), the central rod (106) and the hollow inner tube (102) move distally (together as seen in Figures 5-6) so as to move the surgical mesh carriage out (60) of the distal housing (see Figures 5-6), but fails to disclose:
(ii) the actuation element is moved distally to a second location the central rod moves distally and hinges each of the plurality of legs at their respective first hinged ends so that the plurality of legs assume a radially-expanded configuration.
Johnson teaches an inserter device for delivering a medical device (tampon) comprising an outer tube (13/10; Figures 1-2), a central rod (12; Figures 1-2) slidably disposed within the outer tube (13), an actuation element (18) mounted to the proximal end of the central rod (12), and a surgical mesh carriage comprising a plurality of legs (11) with a hinge (22) disposed between the proximal and distal ends of each of the plurality of legs (11) (Column 5, Lines 36-62), wherein the actuation element (18) is moved distally (as seen in Figure 2), the central rod (12) moved distally and hinges each of the plurality of legs at their respective first hinged ends (20; Figure 2) so that the plurality of legs (11) assume a radially-expanded configuration (as seen in Figure 2).
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute actuation mechanism taught by Kammerer with distally advanceable actuation mechanism as taught by Johnson since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the Johnson reference only teaches a mechanism to deploy hinged legs outwardly in response to distal movement of the actuator, and this mechanism of Johnson would be sufficient to expand the legs taught by Kammerer since both devices are designed to deploy a sheet-like medical device into the body from a delivery configuration (Figure 1) to a deployed expanded configuration (Figure 2). Furthermore, the “moving the actuation element distally to a second location” limitation only applies to a second location once the surgical mesh carriage/legs are deployed out of the outer tube taught by Kammerer, therefore the combination of references would read on the claims because Johnson teaches moving the actuator distally to the second position only to actuate the legs in an expanded position.
Regarding Claim 3, the combination of references disclosed above teaches the apparatus according to claim 2 wherein Kammerer teaches tactile feedback (between elements 164/166 and element 142) is provided to a user when the actuation element reaches the first location (as seen in Figure 6 where locking tab (164/166) is locked and see Figure 5 in which the locking tab (164/166) is unlocked).
Regarding Claim 9, the combination of references disclosed above teaches the apparatus according to claim 2 wherein Kammerer teaches when the plurality of legs (62) are in the radially-expanded configuration (Figure 7), the plurality of legs (62) are disposed generally perpendicular to the longitudinal axis of the hollow outer tube (100; Figure 7).
Regarding Claim 15, the combination of references disclosed above teaches the apparatus according to claim 2 further comprising a handle (104) mounted to the proximal end of the hollow outer tube (100; Figures 5-6).
Regarding Claim 16, the combination of references disclosed above teaches the apparatus according to claim 15 wherein the proximal end of the hollow inner tube (102) comprises a locking collar (112) and the handle (104) comprises a locking tab (166), and further wherein the locking collar (112) is configured to mate with the locking tab (166; see Figure 5 in which the locking tab is not mated with the locking collar and see Figure 6 in which the locking tab is mated with the locking collar).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kammerer (US Patent 5,397,332) in view of Zenz-Olson (US PGPub 2016/0324616) as applied to claim 1 above, and further in view of Dupic (US PGPub 2009/0326676).
Regarding Claim 7, the combination of references disclosed above teaches the apparatus according to claim 1 but fails to disclose wherein the second hinged ends of the plurality of legs are formed integral with each other so as to form a base having a central opening mounted to the distal end of the central rod.
Dupic teaches an apparatus for delivering a hernia prosthesis to a surgical site (Abstract) comprising a outer tube (7b), a central rod (7d), an actuation element (7e) disposed on the proximal end of the central rod (7d), a surgical mesh carriage comprising a plurality of legs (7c) with a first hinged end mounted to the outer tube (7b) and a second hinged end mounted to the central rod (7d) (Paragraph 0022) wherein the second hinged end of the plurality of legs (7c) are moved intergral with each other so as to form a base having a central opening (Paragraph 0022 states that the plurality of legs (7c) are formed of the tube, and thus would be integral to both the outer tube (7b) and themselves and form a base having a central opening such that central rod (7D) can be mounted thereon).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to the plurality of legs of Kammerer to be integral such that they form a base with an opening, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding Claim 8, the combination of references disclosed above teaches the apparatus according to claim 7 wherein both Kammerer and Dupic each teach the distal end of the central rod comprises a plug with a distal portion having a diameter wider than the diameter of the central opening (see Figure 10 of Kammerer which shows the distal end of the central rod (106) comprising a plug (90) which has a diameter wider than the diameter formed by the central opening (see reference number 68) of the plurality of legs (62)(see Figure 2 of Dupic which there is a plug over the distal most part of legs 7c).
Allowable Subject Matter
Claims 4, 17, and 21 would be allowable if rewritten to overcome the double patenting rejections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding Claim 4, the prior art fails to disclose wherein audible feedback is provided to a user when the actuation element reaches the second location.
Regarding Claim 17, the prior art fails to disclose wherein the locking collar snaps over the locking tab so as to provide audible feedback to a user indicating that the plurality of legs are in the radially-expanded configuration.
Regarding Claim 21, the prior art fails to disclose wherein distal movement of the actuation element to the second location causes the locking collar to audibly snap over the locking tab so as to provide feedback to a user indicating that the plurality of legs are in the radially-expanded configuration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771