DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 May 2026 has been entered.
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 Objections
Claim 17 is objected to because of the following informalities:
-Claim 17 recites “the delivery device” in line 14. Examiner recommends amending to –the multi-piece delivery device—
Appropriate correction is required.
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 6, 9-16, 20 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 6 recites “an implantable sheet” in line 5. It is unclear whether this is the same or different from an implantable sheet originally referenced in claim 1, line 2.
-Claim 9 recites “an implantable sheet” in line 17. It is unclear whether this is the same or different from an implantable sheet originally referenced in claim 9, line 2.
-Claim 20 recites “a pair of resilient arms” in line 2. It is unclear whether this is the same or different from a pair of resilient arms originally referenced in claim 17, line 15.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2-5, 7, 8, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Friedlander (WO 2013020107).
Regarding Claim 1, Friedlander teaches a multi-piece delivery device configured to deliver an implantable sheet [Abstract] and [Fig. 1A]—showing the multiple pieces that make up the device, the multi-piece delivery device comprising:
a first body member including a central arm extending along a longitudinal axis between a first proximal end portion of the first body member and a first distal end portion of the first body member [Fig. 1A, element 12 (main shaft)]], the first proximal end portion of the first body member including a tube defining a tube lumen and the first distal end portion of the first body member including a body locking recess defined therein [0036; “The main shaft 12 is hollow and includes a slot 121 near the handle 11, for receiving an actuating pin 141. A hollow flexible tube 13 can be attached to the other end of the main shaft 12.”], wherein the tube [Fig. 1A, element 13 (hollow flexible tube)] and the body locking recess [Fig. 1A, element 141 (actuating pin)] are spaced apart and aligned along the longitudinal axis of the central arm. See annotated Fig. 1A below;
and a second body member positioned on top of the first body member. See annotated Fig. 1A where the second body member including the deployment arms are shown on the top side of the entire device where the top of the device and the top of the first body member is interpreted to be the distal end portion of the first body member, the second body member including a pair of resilient arms [Fig. 1A, elements 18 and 19 (deployment arms)] extending between a second proximal end portion of the second body member and a second distal end portion of the second body member. See annotated Fig. 1A, the second proximal end portion of the second body member including a handle received within the tube lumen of the first body member [Fig. 1A, element 11 (handle)], and the second distal end portion including a locking member received within the body locking recess of the first body member locking the first body member to the second body member [Fig 1A, element 17 (mounting plug)] and [0038; “A deployment arm mounting plug 17 can be affixed to an end of the flexible tube 13.”]
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Regarding Claim 2, Friedlander teaches wherein the tube further comprises a tube slot extending a length of the tube forming a split tube [0077; “The tube 2013 provides flexibility to the apparatus 2010 allowing for a greater range of motion to position and manipulate the mesh 2027. The main shaft 2011 is hollow and includes a moving handle securing slot 2111, and a latch release lever slot 2112, near the fixed handle 2012.”]
Regarding Claim 3, Friedlander teaches wherein the central arm comprises at least a first area which defines a T-shaped cross-section [Fig. 2C, element 221].
Regarding Claim 4, Friedlander teaches wherein the central arm further comprises a second area which defines a T-shaped cross-section [Fig. 2C, element 222], the second area separated longitudinally along the central arm from the first area by a space. See annotated Fig. 2C below.
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Regarding Claim 5, Friedlander teaches wherein the space between the first area and the second area of the central arm comprises one or more tie holes defined therethrough [0042; “The mesh preferably contains a pouch 224 at one end for inserting the tip of the actuator rod 161. The guide loops 221, 222, 223 may be sewn or otherwise affixed to the surface of the mesh 22.”]
Regarding Claim 7, Friedlander teaches wherein the pair of resilient arms are configured to transition between an expanded configuration with the pair of resilient arms spaced farthest apart from each other and a restrained configuration with the pair of resilient arms generally adjacent to each other [0044-0046]—describing the sliding of the main shaft to extend the deployment arms, draw the deployment arms back into the housing and prepare the mesh for deployment shown in Figs. 2A-E.
Regarding Claim 8, Friedlander teaches wherein the handle is configured to slide longitudinally within the tube lumen of the tube [0044; “Once engaged, further inward motion of the handle 11 causes the main shaft 12 with attached flexible tubing 13 and mounting plug 17 to slide over the connecting rod 14, flexible joint 15, and actuator rod 16, while the actuating pin 141 is allowed to slide within the slot 121 in the main shaft 12.”]
Regarding Claim 22, Friedlander teaches wherein the multi-piece delivery device is a two-piece delivery device [0052; “surgical mesh 1102 because the surgical mesh 1102 is simply "sandwiched" between the two halves of the surgical implant deployment member 1108.”]
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) 6, 9-16, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedlander (WO 2013020107) in view of Weiman (U.S. 20110264152).
Regarding Claim 6, Friedlander is silent on wherein the first distal end portion of the first body member further comprises a slot distal to the body locking recess, the slot separating the first distal end portion of the first body member into an upper jaw member and a lower jaw member, the slot configured to secure a distal end portion of an implantable sheet between the upper and lower jaw members. Weiman teaches wherein the first distal end portion of the first body member further comprises a slot distal to the body locking recess [0053; “In the illustrated embodiment, the throughbore 118 in the sleeve 68 enlarges to form a slot 130 in the body portion 124 of the implant holding jaws 112.”], the slot separating the first distal end portion of the first body member into an upper jaw member and a lower jaw member [Fig. 22, elements 126 (upper jaw) and 128 (lower jaw)], the slot configured to secure a distal end portion of an implantable sheet between the upper and lower jaw members [0053; “ In an embodiment, the implant 72 (see, e.g., FIG. 15) is held between the jaw tips 130. In the illustrated embodiment, the jaw tips 130 form a flared opening for receiving the implant 72.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include jaw features of the delivery end of the device as taught by Weiman to hold an implantable sheet as suggested by Friedlander as Friedlander discusses full encapsulation of the implant [0046] with Weiman because Weiman teaches the need to improve insertion tools to securely hold implants while placing them within a patient [0004].
Regarding Claim 9, Friedlander teaches a multi-piece delivery device configured to deliver an implantable sheet [Abstract] and [Fig. 1A]—showing the multiple pieces that make up the device, the multi-piece delivery device comprising: a first body member including a pair of resilient arms [Fig. 1A, elements 18 and 19 (deployment arms)] extending between a first proximal end portion of the first body member and a first distal end portion of the first body member See annotated Fig. 1A, the first proximal end portion of the first body member including a first tube defining a first tube lumen and the first distal end portion of the first body member [Fig. 1A, element 20] and [0039; “hollow outer housing”] including a second tube defining a second tube lumen, the second tube further including a body locking recess defined therein [Fig 1A, element 17 (mounting plug)] and [0038; “The mounting plug 17 includes an internal opening to allow the actuator rod 16 to slide through the mounting plug 17 and is preferably keyed to the actuator rod 16 to prevent rotation about the long axis.”],
and a second body member including a central arm extending along a longitudinal axis between a second proximal end portion of the second body member and a second distal end portion of the second body member [Fig. 1A, element 12 (main shaft)] and see annotated Fig. 1A below, the second proximal end portion of the second body member received within the first tube lumen of the first body member [Fig. 1A, element 13 (hollow flexible tube)], and the second distal end portion of the second body member including a body locking member and a slot distal to the body locking member [0036; “The main shaft 12 is hollow and includes a slot 121 near the handle 11, for receiving an actuating pin 141. A hollow flexible tube 13 can be attached to the other end of the main shaft 12.”], wherein the first tube and the body locking recess of the first body member are spaced apart and aligned along the longitudinal axis of the central arm.
Friedlander is silent on the body locking member received within the body locking recess of the first body member locking the first body member to the second body member and the slot separating the second distal end portion of the second body member into an upper and lower jaw member, the slot configured to secure a distal end portion of an implantable sheet between the upper and lower jaw members. Weiman teaches the body locking member received within the body locking recess of the first body member locking the first body member to the second body member [0053; “In the illustrated embodiment, the throughbore 118 in the sleeve 68 enlarges to form a slot 130 in the body portion 124 of the implant holding jaws 112.”] and the slot separating the second distal end portion of the second body member into an upper and lower jaw member [Fig. 22, elements 126 (upper jaw) and 128 (lower jaw)], the slot configured to secure a distal end portion of an implantable sheet between the upper and lower jaw members [0053; “ In an embodiment, the implant 72 (see, e.g., FIG. 15) is held between the jaw tips 130. In the illustrated embodiment, the jaw tips 130 form a flared opening for receiving the implant 72.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include jaw features of the delivery end of the device as taught by Weiman to hold an implantable sheet as suggested by Friedlander as Friedlander discusses full encapsulation of the implant [0046] with Weiman because Weiman teaches the need to improve insertion tools to securely hold implants while placing them within a patient [0004].
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Regarding Claim 10, Friedlander further teaches wherein the first tube lumen defines a generally square-shaped cross-section [Fig. 5A] and [0049].
Regarding Claim 11, Friedlander further teaches wherein the first tube lumen further comprises a guide member extending a length of the first tube lumen and protruding into at least one side of the generally square-shaped cross-section [Fig. 1A, element 16 (actuating rod)] and enlarged [Figs. 4A-B].
Regarding Claim 12, Friedlander further teaches wherein at least the second proximal end portion of the second body member defines a generally square-shaped cross-section [Fig. 5A] including at least one groove extending a length of the second body member, the at least one groove configured to accommodate the guide member [Fig. 1A, element 15 (flexible joint)] and [0037; “The connecting rod 14, flexible joint 15, and actuator rod 16 are positioned internally to the main shaft 12 and flexible tube 13.”]
Regarding Claim 13, Friedlander further teaches wherein each arm of the pair of the resilient arms define a half-moon cross-section [Fig. 21B, elements 2201 and 2202 (deployment arms)].
Regarding Claim 14, Friedlander further teaches wherein the central arm further comprises first and second tie holes defined therethrough [0042; “The mesh preferably contains a pouch 224 at one end for inserting the tip of the actuator rod 161. The guide loops 221, 222, 223 may be sewn or otherwise affixed to the surface of the mesh 22.”]
Regarding Claim 15, Friedlander further teaches wherein the pair of resilient arms are configured to transition between an expanded configuration with the pair of resilient arms spaced apart from each other and a restrained configuration with the pair of resilient arms generally adjacent to each other [0044-0046]—describing the sliding of the main shaft to extend the deployment arms, draw the deployment arms back into the housing and prepare the mesh for deployment shown in Figs. 2A-E.
Regarding Claim 16, Friedlander further teaches wherein the first tube is configured to slide longitudinally along the second proximal end portion of the second body member [0044; “Once engaged, further inward motion of the handle 11 causes the main shaft 12 with attached flexible tubing 13 and mounting plug 17 to slide over the connecting rod 14, flexible joint 15, and actuator rod 16, while the actuating pin 141 is allowed to slide within the slot 121 in the main shaft 12.”]
Regarding Claim 23, Friedlander further teaches wherein the multi-piece delivery device is a two-piece delivery device [0052; “surgical mesh 1102 because the surgical mesh 1102 is simply "sandwiched" between the two halves of the surgical implant deployment member 1108.”]
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Claims 17-19, 21 are allowable over the prior art of record. Regarding claims 17-19, 21, while the prior art teaches “A surgical kit comprising: a multi-piece delivery device configured to deliver an implantable sheet, an elongate body extending between an insertion end portion including a first socket and a rolling end portion including a second socket, the insertion member elongate body defining a first longitudinal axis, and each of the first and second sockets being configured to matingly engage the a proximal end portion of the multi-piece delivery device” the prior art of record does not teach or fairly suggest “and an insertion member including an elongate body, a clamp tube, and a finger, the clamp tube having a tubular body extending between a first clamp tube end portion and a second clamp tube end portion opposite the first clamp tube end portion, the first clamp tube end portion configured to attach to and extend away from the rolling end portion of the elongate body, the second clamp tube end portion being free of the elongate body and configured to receive at least the proximal end portion of the delivery device therein to transition a pair of resilient arms from an expanded configuration to a restrained configuration, and the finger extending between a fixed first end portion and a free second end portion, the fixed first end portion affixed to the rolling end portion of the elongate body, the free second end portion extending away from the rolling end portion of the insertion member elongate body and over at least the first clamp tube end portion of the clamp tube, the free second end portion of the finger defining a sheet gap between the finger and the clamp tube, the sheet gap configured to receive and maintain a proximal end of the implantable sheet.
Prior Art Kieturakis et al. (U.S. 6540764)—references a tunneling apparatus that includes a pinch clamp, section to be engaged by the provider and a rotating of elements in response to the finger section being triggered. The mechanisms described provided manipulation of the balloon of the distal end of the device.
Prior Art Peartree (U.S. 6592602)—includes clamps on a cannula tube that provides sealing portions of a balloon against a skin of a patient. The pinch clamp described is used to permit saline inflow into the balloons to translate the balloon from a deflated to inflated condition.
Prior Art Darois (U.S. 20110306992)—indicates a suturing device that includes hernia repair patches for use with the device. The invention also discloses use of clamp instruments to be applied to an inflation tube to assist in positioning and rotation of the orientation of the patch.
Claim 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 26 May 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive however, new rejections are
presented in light of the amendments.
Applicant’s arguments filed 26 May 2026 with respect to the rejection of
claims 1-18 under 35 U.S.C.103 have been fully considered and are persuasive,
however, new rejections are presented citing Friedlander for claims 1-5, 7-8 and 23, and citing Friedlander in view of Weiman for claims 6, 9-16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Harris (U.S. 20080319455)—includes a deployment device with articulating arms
-Hansen (U.S. 20140107675)—discusses a hernia repair system including elongate members
-von Pechmann (U.S. 20110174313)—discloses a mesh delivery system with stabilizer components
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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