DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 29 October 2025 Claims 1-18 are now pending. The Examiner acknowledges the amendments to claims 1, 4, 5, 6, 7, 9, 11, 12, 13, 14, 15, 17, 18.
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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 9, 17 are objected to because of the following informalities:
-Claim 9 recites “the locking member” in line 14. Examiner recommends amending to –the body locking member—
-Claim 17 recites “the delivery device” in line 13. Examiner recommends amending to –the two-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 9-16, 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 9 recites “the tube” in line 18. It is unclear which tube is being referred to in this recitation. Further clarification should be provided to identify whether this is in reference to the first tube, second tube or a separate embodiment.
-Claim 9 recites “the body locking recess” in line 18. It is unclear which structure this is referring to. Further clarification should be provided to identify whether this is the body locking recess of the first or second body member, or a separate embodiment.
-Claim 14 recites “the arm” in lines 1-2. It is unclear whether this is referring to an arm of the pair of resilient arms of the first body member or the arm of the second body member. Further clarification should be provided. Should possibly read –each arm—
-Claim 17 recites “the proximal end portion” in line 7. There is insufficient antecedent basis for this limitation in the claim.
-Claim 17 recites “a clamp tube….rolling end portion of the insertion member” in lines 9-10. It is unclear whether this limitation requires the clamp tube, the tubular body of the clamp tube, the first clamp tube portion, or a separate embodiment attaches to and extends away from the rolling end portion of the insertion member. Further clarification should be provided.
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.
Claims 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina (U.S. 20120259347) in view of Loughnane (U.S. 20190380829).
Regarding Claim 1, Abuzaina teaches a two-piece delivery device configured to deliver an implantable sheet, [0102; “implant deployment device 100 is defined hereinafter as a surgical device which can introduce a implant into a body cavity of a patient;”] and [0103; “In general, implant deployment device 100 comprises at least two portions: a distal portion 101 and a proximal portion 102.”] In this interpretation, the two pieces of the device are interpreted to be distal and proximal portions.
The two-piece delivery device comprising: a first body member including a central arm extending between a first proximal end portion of the first body member and a first distal end portion of the first body member, [Fig. 6D, element 601 (first distal end portion) and 617 (first proximal end portion)].
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, [Fig. 6D, element 623 (sleeve positioning member)] and [0108; “locking bar 203 is located inside groove 204 at frame arm 104. Said locking bar 203 can move linearly inside said groove 204 and comprises at least one groove 205.”]—interpreted to be the body locking recess, and [0139; “In some embodiments, the at least one sleeve deployment system includes at least one sleeve positioning member 623 attached to the at least one sleeve 613, the member 623 configured to position the at least one sleeve 613 over at least a portion of at least one of the plurality of arms]. In this interpretation, the sleeve, which mentioned in the prior art of record, represents the tube and tube lumen structures due to the reference also cited in [0139; “The sleeve positioning member 623 may include, for example, at least one cable, pushrod or other device for actuating the sleeve 613.”]
And a second body member positioned on top of the first body member, [Fig. 6D, shows top view of device]. Arms, 600A and 600B located on top of central apertures 617 and 601].
The second body member including a pair of resilient arms extending between a second proximal end portion of the second body member and a second distal end portion of the second body member, [Fig. 6D, elements 600A (second proximal end portion) and 600B (second distal end portion)].
The second proximal end portion of the second body member including a handle received within the tube lumen of the first body member, [0132; “The system 600 includes a handle 602 with an elongate shaft 601 connected to the handle 602.”] This recitation is broadly interpreted since all structural components of the device are mentioned. The limitation is interpreted to require that the handle is contacting the first body member since it requires being received within the tube lumen of the first body member.
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 107] and [0133; “the at least one distal member 611 may be connected to the actuation member 617 at a fourth connection 615. Thus, the deployment scaffold 600A may include members 605, 609, 611, and 617, and connections 603, 607, 608 and 615. Connections 603, 607, 608 and 615 may be any type of hinge, such as but not limited to, mechanical hinges, living hinges, ball and socket joints, etc.”]
Abuzaina is silent on wherein the tube and the body locking recess are spaced apart and aligned along the longitudinal axis. Loughnane teaches wherein the tube and the body locking recess are spaced apart and aligned along the longitudinal axis [0092; “The second locking portion or buckle member 74 may include a body portion fixedly attached to and/or integrally formed with the base portion, the body portion defining a longitudinal channel extending through the body portion of the second locking portion or buckle member 74.”] and [0093; “the second locking portion or buckle member 74 may include at least one hole or aperture formed therein for attaching a radiopaque marker to the second locking portion or buckle member 74”]—referenced structures include the channel, interpreted to be the tube, second locking portion/buckle member, interpreted to be the body locking recess with reference to this structure including a hole and all described parts being spaced apart and aligned with the longitudinal channel representing an axis of reference.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to align the various structures with a longitudinal axes as taught by Loughnane to allow for movement and positioning of the implant as suggested by Abuzaina, as Abuzaina discusses the importance of this movement to fit the implant to the hernia which is often of an asymmetric shape [0093] with Loughnane because Loughnane teaches the beneficial aspects of aiding visualization of the locking mechanisms and to allow for bias of the implant towards a central portion of the device to align with the device [0093-0094].
Regarding Claim 2, Abuzaina teaches the two-piece delivery device of claim 1. Abuzaina further teaches wherein the tube further comprises a tube slot extending a length of the tube forming a split tube [0143; “Referring to FIG. 8, the sleeve deployment system may further include an articulation member 801 attaching the elongate shaft 601 to the proximal members 605. The actuation member 617 may slidably pass through the articulation member 801 from the elongate shaft 601 and attach to the distal members 611 such that distal sliding forces the system into the retracted position and proximal sliding forces the system into the deployed position.”] In this embodiment, the sleeve deployment system still represents the tube, the articulation member represents the tube slot and the split tube is interpreted as a dual-mechanism retraction and deployed system.
Regarding Claim 3, Abuzaina teaches the two-piece delivery device of claim 1. Abuzaina further teaches wherein the central arm comprises at least a first area which defines a T-shaped cross-section [0133; “The frame 600B may be assembled such that the at least one proximal member 605 attaches to the elongate shaft 601 at a first hinge 603 and to at least one of the deployment arms 609 at a second connection 607.”] See annotated Fig. 6D below.
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Regarding Claim 4, Abuzaina further teaches wherein the central arm further comprises a second area which defines a T-shaped cross-section, the second area separated longitudinally along the central arm from the first area by a space [0133; “the at least one distal member 611 may be connected to the actuation member 617 at a fourth connection 615. Thus, the deployment scaffold 600A may include members 605, 609, 611, and 617, and connections 603, 607, 608 and 615. Connections 603, 607, 608 and 615 may be any type of hinge, such as but not limited to, mechanical hinges, living hinges, ball and socket joints, etc.”] See annotated Fig. 6D below.
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Regarding Claim 7, Abuzaina teaches the two-piece delivery device of claim 1. Abuzaina further 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 [Fig. 6A, elements 600A and 600B].
And a restrained configuration with the pair of resilient arms generally adjacent each other [Fig. 6B, elements 600A and 600B]. In this embodiment, elements are not called out but referenced in [0133; “The frame 600B/scaffold 600A is configured to move from a retained position as shown in FIGS. 6B and 6C, to at least one deployed position as shown in FIG. 6A, and vice versa by distal and proximal movement of the actuation member 617, respectively.”]
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina (U.S. 20120259347) in view of Loughnane (U.S. 20190380829) and in further view of Chapman (U.S. 20110112357).
Regarding Claim 5, Abuzaina is silent on wherein the space between the first area and the second area of the central arm further comprises one or more tie holes defined therethrough. Chapman teaches wherein the space between the first area and the second area of the central arm further comprises one or more tie holes defined therethrough, See annotated Fig. 23 below.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide an attachment means such as a tie hole in a specific orientation to the delivery device as taught by Chapman to allow for attachment of the implant to the delivery device as suggested by Abuzaina, and Loughnane, as Abuzaina discusses various configurations of the attachment between the implant and delivery device [0044] and Loughnane which discloses a heart valve implant releasably attached to the coupler [0015] with Chapman because Chapman teaches connectors attached to the ends of the extension portions of the implant for connecting with the insertion tool [0014].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina (U.S. 20120259347) in view of Loughnane (U.S. 20190380829) and in further view of Berry (U.S. 20080275455).
Regarding Claim 6, Abuzaina and Loughnane are 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. Berry teaches wherein the first distal end portion of the first body member further comprises a slot distal to the body locking recess [Fig. 19, elements 1914 (shaft/slot), 1920 (locking arm/body locking recess)]. In this embodiment the slot is represented by the shaft 1914 and the locking recess is represented by 1920, the slot separating the first distal end portion of the first body member into an upper jaw member and a lower jaw member [Fig. 19, elements 1924 and 1928 (ramps/lower jaw member)] and [Fig. 20, elements 1936 and 1950 (distraction guides and inner faces/upper jaw member], the slot configured to secure a distal end portion of an implantable sheet between the upper and lower jaw members [Figs. 19 and 20, element G5] and [0074; “A plurality of distraction guides 1936 may have dimensions that are customized to match various respective implants G5.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide clamping or jaw-like members to hold the implant towards the end of delivery device as taught by Berry to allow for insertion and delivery of the implant by means of the delivery device as suggested by Abuzaina, and Loughnane, as Abuzaina discusses inserting the system into a surgical site using specific positioning of the delivery device [0064] and Loughnane which discloses the insertion of the implant percutaneously and less invasively [0049] with Berry because Berry teaches the use of an integrated singular instrument to control the surgeon’s access and visualization of the implant site [0008].
Claim(s) 9, 10, 11, 12, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina (U.S. 20120259347) in view of Berry (U.S. 20080275455) and in further view of Loughnane (U.S. 20190380829).
Regarding Claim 9, Abuzaina teaches a two-piece delivery device configured to deliver an implantable sheet [0102; “implant deployment device 100 is defined hereinafter as a surgical device which can introduce a implant into a body cavity of a patient;”] and [0103; “In general, implant deployment device 100 comprises at least two portions: a distal portion 101 and a proximal portion 102.”] In this interpretation, the two pieces of the device are interpreted to be distal and proximal portions,
the two-piece delivery device comprising: a first body member including a pair of resilient arms extending between a first proximal end portion of the first body member and a first distal end portion of the first body member [Fig. 6D, elements 600A and 600B], the first proximal end portion of the first body member including a first tube defining a first tube lumen [Fig. 6D, element 623], and the first distal end portion of the first body member including a second tube defining a second tube lumen [Fig. 6D, 601],
Abuzaina is silent on the second tube further including a body locking recess defined therein, and a second body member including an 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, the second proximal end portion of the second body member received within the first tube lumen of the first body member, 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, the 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, wherein the tube and the body locking recess are spaced apart and aligned along the longitudinal axis. Berry teaches the second tube further including a body locking recess defined therein [0075; “Tube 1916 may move along base 1912 employing sliding contact, rolling contact, or other suitable motion interface. In one or more alternative embodiments, once the tube 1916 is in a desired position with respect to the base 1912, the tube 1916 may be locked into place using a locking arm 1920.”], and a second body member including an 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. 19, element 1912]—depicting the base, element 1912, extends along the longitudinal axis of the delivery device, the second proximal end portion of the second body member received within the first tube lumen of the first body member [Fig. 19, element 1914], 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 [Fig. 19, elements 1914, 1920], the 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 [Fig. 19, elements 1914, 1920] and [Fig. 19, elements 1924 and 1928] and [Fig. 20, elements 1936 and 1950], the slot configured to secure a distal end portion of an implantable sheet between the upper and lower jaw members [Figs. 19 and 20, element G5] and [0074; “A plurality of distraction guides 1936 may have dimensions that are customized to match various respective implants G5.”],
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide clamping or jaw-like members to hold the implant towards the end of delivery device as taught by Berry to allow for insertion and delivery of the implant by means of the delivery device as suggested by Abuzaina, as Abuzaina discusses inserting the system into a surgical site using specific positioning of the delivery device [0064] with Berry because Berry teaches the use of an integrated singular instrument to control the surgeon’s access and visualization of the implant site [0008].
Abuzaina and Berry are silent on wherein the tube and the body locking recess are spaced apart and aligned along the longitudinal axis. Loughnane teaches wherein the tube and the body locking recess are spaced apart and aligned along the longitudinal axis [0092; “The second locking portion or buckle member 74 may include a body portion fixedly attached to and/or integrally formed with the base portion, the body portion defining a longitudinal channel extending through the body portion of the second locking portion or buckle member 74.”] and [0093; “the second locking portion or buckle member 74 may include at least one hole or aperture formed therein for attaching a radiopaque marker to the second locking portion or buckle member 74”]—referenced structures include the channel, interpreted to be the tube, second locking portion/buckle member, interpreted to be the body locking recess with reference to this structure including a hole and all described parts being spaced apart and aligned with the longitudinal channel representing an axis of reference.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to align the various structures with a longitudinal axes as taught by Loughnane to allow for movement and positioning of the implant as suggested by Abuzaina, and Berry, as Abuzaina discusses the importance of this movement to fit the implant to the hernia which is often of an asymmetric shape [0093] and Berry which discusses the associated procedure of insertion including considerations or insertion direction and alignment [0080] with Loughnane because Loughnane teaches the beneficial aspects of aiding visualization of the locking mechanisms and to allow for bias of the implant towards a central portion of the device to align with the device [0093-0094].
Regarding Claim 10, Abuzaina and Loughnane are silent on wherein the first tube lumen defines a generally square-shaped cross-section. Berry teaches wherein the first tube lumen defines a generally square-shaped cross-section [0017; “In one or more embodiments, the tube mechanism may include a square surface attached to a threaded member that may be engaged at the distal end.”]
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Abuzaina which discusses the use of various shapes for the sleeve or first tube lumen to cover structures in various deployment or retention positions [0137; “The at least one sleeve 613 may be shaped to further selectively cover at least one of the hinges connecting the deployment arms 609 to the frame 600B when the frame 600B is in the either the retained position or deployed position.”] with Berry because Berry teaches the use of this structure to quickly and easily release implants within the anatomical space [055; “Insertion instrument 10 may further include a tube mechanism, or simply "tube", 16 which may be operationally coupled to the clamp components 46 for quickly and easily releasing the implant G within the intervertebral space.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to shape the tube lumen as specified by the requirements of the claim as taught by Berry to cover certain structures in various configurations as suggested by Abuzaina, and Loughnane, as Abuzaina discusses the use of various shapes for the sleeve or first tube lumen to cover structures in various deployment or retention positions [0137] and Loughnane which discusses the various shapes and sizes of the distraction guides to correspond with sizes and shapes of implants [0077] with Berry because Berry teaches the use of this structure to quickly and easily release implants within the anatomical space [055].
Regarding Claim 11, Abuzaina and Loughnane are silent on 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. Berry 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. 20, element 1918] and [0076; “The shaft 1914 may include a threaded tip 1918, at the distal end thereof, that may engage the implant GS by means of a threaded hole G6 on the proximal side of the implant.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a guide member extending the length of the tube lumen protruding into the square shaped cross section as taught by Berry to release and insert implants as suggested by Abuzaina, and Loughnane, as Abuzaina discusses the use of various shapes for the sleeve or first tube lumen to cover structures in various deployment or retention positions [0137] and Loughnane which discusses the various shapes and sizes of the distraction guides to correspond with sizes and shapes of implants [0077] with Berry because Berry teaches the use of this structure to quickly and easily release implants within the anatomical space [055].
Regarding Claim 12, Abuzaina and Loughnane are silent on wherein at least the second proximal end portion of the second body member defines a generally square-shaped cross-section including at least one groove extending a length of the second body member, the at least one groove configured to accommodate the guide member.
Berry teaches wherein at least the second proximal end portion of the second body member defines a generally square-shaped cross-section including at least one groove extending a length of the second body member, the groove configured to accommodate the guide member [Fig. 20, element 1954] and [0074; “In one or more embodiments, guide pins 1952 on the medial side of the arms 1922 may be located within holes 1954 on the base 1912 to enable the lateral motion of the arms 1922.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a groove to accommodate the guide member as taught by Berry to release and insert implants as suggested by Abuzaina, and Loughnane, as Abuzaina discusses the use of groove-like structures contained within the arms of the surgical device to move linearly and work in tandem with a locking bar to move between the deployment positions [0108] and Loughnane which discusses including a tubular guide member that is disposed over each arm and/or fingers [0077] with Berry because Berry teaches the use of various guides including not just that of the holes and guide pins but also the distraction guides 1936, that can be sized and shaped to accommodate various implants [0074].
Regarding Claim 15, Abuzaina further 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 [Fig. 6A, elements 600A and 600B].
And a restrained configuration with the pair of resilient arms generally adjacent each other. [Fig. 6B, elements 600A and 600B]. In this embodiment, elements are not called out but referenced in [0133; “The frame 600B/scaffold 600A is configured to move from a retained position as shown in FIGS. 6B and 6C, to at least one deployed position as shown in FIG. 6A, and vice versa by distal and proximal movement of the actuation member 617, respectively.”]
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina (U.S. 20120259347) in view of Loughnane (U.S. 20190380829) and in further view of Kieturakis (U.S. 5464403).
Regarding Claim 8, Abuzaina and Loughnane are silent on wherein the handle is configured to slide longitudinally within the tube lumen of the tube. Kieturakis teaches wherein the handle is configured to slide longitudinally within the tube lumen of the tube [Col 8, lines 1-7; “FIGS. 15-17 and consists of a tubular assembly 142 on which there is mounted a handle 146. The tubular assembly 142 consists of a tubular member 147 which is slidably mounted in a sleeve 148 secured to the handle 146. The distal extremity of the sleeve 148 is provided with a slot 149 which is open at its distal extremity.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a handle slidably configured to move within the tube lumen of the tube as taught by Kieturakis to allow for a sliding motion included in the insertion and delivery of the implant by means of the delivery device as suggested by Abuzaina, and Loughnane, as Abuzaina discusses the sleeve positioning member slidably connected to the frame to follow the shape of the frame [0141] and Loughnane which discloses an actuation means to slidably actuate and translate the catheter to deliver the implant [0081] with Kieturakis because Kieturakis teaches a similar concept of the tubular structures within the device moving longitudinally over the rod to deploy the mesh [Col 8, lines 23-29].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina (U.S. 20120259347) in view of Berry (U.S. 20080275455) and in further view of Loughnane (U.S. 20190380829) and in even further view of Kieturakis (U.S. 5464403).
Regarding Claim 16, Abuzaina, Berry and Loughnane are silent on wherein the first tube is configured to slide longitudinally along the second proximal end portion of the second body member.
Kieturakis teaches wherein the first tube is configured to slide longitudinally along the second proximal end portion of the second body member [Col 8, lines 23-29; “Thus, they can be used for moving the tubular member 147 longitudinally over the rod 151 to push the mesh 56 off the means carried by the distal extremity of the rod for retaining the mesh so that the mesh can be rapidly discharged from the placement tool after it has been introduced into the cavity in which it is to be disposed.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a tube or channel slidably configured to move within the tube lumen of the tube as taught by Kieturakis to allow for a sliding motion included in the insertion and delivery of the implant by means of the delivery device as suggested by Abuzaina, Berry, and Loughnane, as Abuzaina discusses the sleeve positioning member slidably connected to the frame to follow the shape of the frame [0141] and Berry which discusses the implant sliding engaging and moving laterally inward and outward of the shaft [0076] and Loughnane which discloses an actuation means to slidably actuate and translate the catheter to deliver the implant [0081] with Kieturakis because Kieturakis teaches a similar concept of the tubular structures within the device moving longitudinally over the rod to deploy the mesh [Col 8, lines 23-29].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina (U.S. 20120259347) in view of Berry (U.S. 20080275455) and in further view of Loughnane (U.S. 20190380829) and in even further view of Houser (U.S. 20030060685).
Regarding Claim 13, Abuzaina and Berry are silent on wherein each arm of the pair of the resilient arms define a half-moon cross-section. Houser teaches wherein each arm of the pair of the resilient arms define a half-moon cross-section [0122; “Moreover, referring to FIGS. 13-16, the arm segment 115 can be fabricated from a superelastic material, such as a superelastic shape memory metal or plastic, have a semicircular profile (FIG. 13) when unrestrained, and have a reduced diameter, low profile shape when restrained (FIG. 14).”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to structure the arms in half-moon cross sectional shapes as taught by Houser to allow for retraction and deployment as suggested by Abuzaina, and Loughnane, and Berry as Abuzaina discusses the sleeve positioning member slidably connected to the frame to follow the shape of the frame [0141] and Loughnane which discloses coordinating cross sectional shapes of different structural elements to correspond with actuation [0086] and Berry which discusses shaping and sizing structural elements to correspond with different implants [0077] with Houser because Houser teaches the use of certain shapes to move the arms into position and securing the arms in the desired position by matching geometry [0085].
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of a half-moon cross section, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abuzaina (U.S. 20120259347) in view of Berry (U.S. 20080275455) and in further view of Loughnane (U.S. 20190380829) and in even further view of Chapman (U.S. 20110112357).
Regarding Claim 14, Abuzaina, Berry and Loughnane are silent on wherein the arm further comprises first and second tie holes defined therethrough.
Chapman teaches wherein the arm further comprises first and second tie holes defined therethrough See annotated Fig. 23 below.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide an attachment means such as a tie hole in a specific orientation to the delivery device as taught by Chapman to allow for attachment of the implant to the delivery device as suggested by Abuzaina, Berry and Loughnane as Abuzaina discusses various configurations of the attachment between the implant and delivery device [0044] and Berry which discloses the implant being removably attached to the arms and Loughnane which discloses a heart valve implant releasably attached to the coupler [0015] with Chapman because Chapman teaches connectors attached to the ends of the extension portions of the implant for connecting with the insertion tool [0014].
Claim(s) 17, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti (U.S. 20070088362) in view of Abuzaina (U.S. 20120259347).
Regarding Claim 17, Bonutti teaches a surgical kit comprising: a two-piece delivery device configured to deliver an implantable sheet; [0110; “The device, its components, fasteners, drill bits, sutures, and other apparatus disclosed herein may be package in a kit. The kit may be set-up of a specific procedure, such as repair of a fractured bone, securing of an implant, approximating body tissue, etc.”]
And an insertion member including: an elongate body extending between an insertion end portion including a first socket and a rolling end portion including a second socket, [Fig. 3, and 5 elements 54, 58, 32]. In these embodiments, 54 represents the insertion member, 58 represents the first socket and 32 represents the second socket. The rolling end portion is represented in [0083; “The suture 56 may be grabbed by rotating the suture claw 58 and allowing the suture 56 to wrap around the hook 60 at the distal end of the suture claw 58.”]
The insertion member defining a first longitudinal axis, and each of the first and second sockets being configured to matingly engage the proximal end portion of the two-piece delivery device, [0048; “The device includes a generally cylindrical handle 22 and a hook 24 with a proximal end connected to the handle 22.”] In this embodiment, the handle is comprised of elements 54, 58, 32 and engages with the delivery device which is considered 24.
A clamp tube having a tubular body extending between a first clamp tube end portion configured to attach to and extend away from the rolling end portion of the insertion member and a second clamp tube end portion opposite the first clamp tube end portion, [0098; “FIG. 17 shows a tubular clamp member 84 connected with the handle 22 of the device 20,70. The clamp member 84 includes a lumen extending therethrough for allowing passage of the drill system, suture claw, and suture as previously described.”], further see annotated Fig. 18 below with indicators showing that [0083] describes the rotating nature of the suture claw shown to include rolling end portions of this rotating component. Therefore, since rolling end portions are located on opposite sides of the handle, the first clamp tube can be interpreted to extend away from both of these structures. Also due to the indefiniteness of the claim, the examiner is interpreting the limitation requiring the rolling end portion to extend away from the clamp tube, however, with the way the claim is written, it’s unclear whether this limitation requires the clamp tube, the tubular body of the clamp tube, the first clamp tube portion, or a separate embodiment to attach to and extend away from the rolling end portion of the insertion member.
The second clamp tube end portion being free of the insertion member 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, [0104; “A squeeze/finger grip 92 is connected with the handle 22 for advancing and retracting the clamp member 84 relative to the handle 22. When the squeeze grip 92 is moved toward the handle 22, the clamp member 84 may be moved or ratcheted distally thereby pressing the tissue pad 88 against the bone or other tissue. In this configuration, the clamp member functions like a come-along with detents and/or teeth.”]
And a finger extending between a fixed first end portion and a free second end portion, [Fig. 18, element 92]. See annotated Fig. 18 below.
The fixed first end portion affixed to the rolling end portion of the insertion member, [Fig. 18, element 92 and 22]. In this embodiment, the rolling end portion is considered to be contained within the handle and thereof affixed to the handle. See annotated Fig. 18 below.
The free second end portion extending away from the rolling end portion of the insertion member and over at least the first clamp tube end portion of the clamp tube, [Fig. 18, element 92]. See annotated Fig. 18 below.
The free second end portion of the finger defining a sheet gap between the finger and the clamp tube, See annotated Fig. 18 below for additional rolling end portion depicted.
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Bonutti is silent on the sheet gap configured to receive and maintain a proximal end of an implantable mesh.
Abuzaina teaches the sheet gap configured to receive and maintain a proximal end of an implantable mesh [Fig. 6D, element 621].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to re-arrange the implantable sheet to receive the proximal end of the mesh as taught by Abuzaina to allow for attachment of the implant to the delivery device as suggested by Bonutti as Bonutti discusses connecting the fastener with the distal end of the pushrod [0054] with Abuzaina because Abuzaina teaches creating a fast and intuitive method for creating a reliable connection between an implant and implant deployment device [0084].
Regarding Claim 18, Bonutti further teaches wherein the clamp tube further comprises one or more longitudinal slots defined therethrough [0148, Claim 11; “a guide slot disposed in the handle, the guide slot having a longitudinal axis generally aligned with the socket member.”]
Response to Arguments
Applicant's arguments filed 29 October 2025 with respect to the drawing objections have been fully considered and are persuasive in light of the amendments.
Applicant's arguments filed 29 October 2025 with respect to the claim objections have been fully considered however, new objections are presented in light of the amendments.
Applicant's arguments filed 29 October 2025 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive however, new rejections are
presented for claims 5, 9-16, 17-18 in light of the amendments.
Applicant’s arguments filed 29 October 2025 with respect to the rejection of
claim 1 under 35 U.S.C.102 have been fully considered and are persuasive however, new rejections are presented under 35 U.S.C. 103 in light of the amendments claims 1-8.
Applicant’s arguments filed 29 October 2025 with respect to the rejection of
Claim 9 under 35 U.S.C.103 have been fully considered and are persuasive, however, new rejections are presented above in light of the amendments for claims 9-16.
Applicant’s arguments filed 29 October 2025 with respect to the rejection of
Claim 17 under 35 U.S.C.103 citing Bonutti in view of Abuzaina have been fully considered but they are not persuasive. Applicant contends that the cited reference fails to disclose a surgical kit including a clamp tube configured to attach to and extend away from an insertion member, and a finger affixed to the insertion member and configured to extend away from the insertion member and over the clamp tube to define a sheet gap between the finger and the clamp tube. However, this argument is not persuasive. In response to applicant’s argument that the references fail to teach certain features of the invention, it is noted that the limitation involved in the teaching includes indefinite aspects and is construed as best possible as outlined in the rejection above. The examiner is interpreting the limitation requiring the rolling end portion to extend away from the clamp tube, however, with the way the claim is written, it’s unclear whether this limitation requires the clamp tube, the tubular body of the clamp tube, the first clamp tube portion, or a separate embodiment to attach to and extend away from the rolling end portion of the insertion member. Additional reference to the rolling end portions of the insertion member are depicted and clarified for Fig. 18. Since the insertion member is described in [0083] includes rolling end portions of this rotating component since the entire structure can be rotated. Therefore, since rolling end portions are located on opposite sides of the handle, the first clamp tube can be interpreted to extend away from both of these structures. Furthermore, the recitation of extends away is broadly interpreted in this limitation because it is not specifically described which portions of the elongate structures described extend to or away from each other. This is also somewhat vague in terms of a static structure since extending away implies a movement, lengthening or spreading of the recited structure. Therefore, this limitation is broadly interpreted and represented in the above 35 U.S.C. 103 rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791