DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 34-37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Horvath; Christopher et al. (US 20120165722 A1) with incorporation of Yu; Dao-Yi et al. (US 20080108933 A1) in view of Horvath ‘175; Christopher et al. (US 20120197175 A1) in view of De Juan, Jr.; Eugene et al. (US 20110028883 A1).
Regarding claim 34, Horvath discloses a method of implanting an ocular implant within an eye (¶ [0002], devices and methods for implanting a shunt in the suprachoroidal space of an eye; ¶ [0006], [0042], [0043], FIG. 1A … shunt deployment device 100);
the method comprising: inserting a distal end of a delivery device loaded with an implant within an insertion sleeve of the delivery device (¶ [0045] Distal portion 101b includes a capsule 129 and an outer stiff hollow sleeve 130; ¶ [0045], The hollow sleeve 130 is configured for insertion into an eye and to extend into an anterior chamber of an eye; ¶ [0057] Generally, hollow shaft 104 is configured to hold an intraocular shunt 115. An exemplary intraocular shunt 115 in shown in FIG. 7);
through a pre-formed corneal incision into an anterior chamber of an eye (¶ [0066], devices of the invention may be inserted into the eye using … an ab interno approach (entering through the cornea) … an ab interno approach as shown Yu et al. (U.S. Pat. No. 6,544,249 and U.S. patent application number 2008/0108933) and Prywes (U.S. Pat. No. 6,007,511), the content of each of which is incorporated by reference herein in its entirety);
advancing a distal end of the delivery device across the anterior chamber to an anterior chamber angle adjacent an implantation site; advancing the distal end of the delivery device into the implantation site (¶ [0067], FIG. 10B shows protrusion 131 and sleeve 130 fitted within the anterior chamber angle 143 of the eye 140; ¶ [0068], The shape of the protrusion 131 is such that it corrects for an insertion angle that is too steep or too shallow, ensuring that the sleeve 130 is fitted into the anterior chamber angle of the eye, the place for proper deployment of an intraocular shunt);
actuating a trigger such that the implant reacts against a distal end of an implant pusher tube of the delivery device as the trigger is actuated, thus deploying the implant into the implantation site (¶ [0062], FIG. 8 shows a cross-sectional view of deployment mechanism 103 … Member 114b is connected to a pusher component 118 … Movement of member 114b engages pusher 118 and results in pusher 118 advancing within hollow shaft 104); and
removing the delivery device from the eye (¶ [0082], the sleeve 130 is also pulled backward and the proximal portion of the shunt 115 is exposed from within the sleeve 130 and resides within the anterior chamber 141 of the eye 140 (FIG. 15B). The operator continues to apply backward force until the device 100 is completely withdrawn from the eye 140).
Regarding the pre-formed corneal incision, Yu; Dao-Yi et al. (US 20080108933 A1) discloses a step of introducing an insertion sleeve through a pre-formed corneal incision and into an anterior chamber of an eye (¶ [0085], Alternatively, the surgeon may first make an incision in the eye and insert needle 22 through the incision).
Horvath teaches the invention substantially as claimed by Applicant with except for a manually controlled trigger that extends outside the outer housing. Horvath ‘175 discloses methods, systems, apparatus and shunts for treating glaucoma (¶ [0008], [0011], [0018]);
comprising: a generally elongated ergonomic outer housing (¶ [0067] One example of an implantation apparatus 10 and system … in FIGS. 3-9; ¶ [0068] As shown in FIG. 3, implantation apparatus 10 includes a generally cylindrical body or housing 34);
an elongated insertion sleeve partially disposed in the outer housing and having a lumen (¶ [0076], A hollow needle 22 attached to needle mount 23 is mounted on needle hub 96); and
an implant pusher tube partially disposed in and extending outwardly from the distal end of the outer housing, passing through at least a portion of the lumen of the insertion sleeve (¶ [0076], Plunger tube 32 extends from plunger cylinder 88);
an implant supported within the distal portion of the insertion sleeve and in line with a distal end of the implant pusher tube (¶ [0079], FIG. 10, shunt 26 is typically placed on guidewire 28 near the distal end thereof within hollow needle 22); and
a manually controlled trigger, an actuatable portion of which extends outside the outer housing, mechanically coupled to the outer housing such that actuation of the trigger deploys the implant into an implantation location within an eye (¶ [0088], FIG. 13, implantation apparatus 130 includes handle portion 132 with a needle assembly 134 attached to the distal end of body 132. A thumbwheel 136 is rotatable and coupled to an internal screw … such that turning of thumbscrew 136 effects axial movement of needle assembly 134; ¶ [0089], FIG. 13, a second thumbwheel 142 is mechanically coupled to guidewire 28. A rotation of thumbwheel 142 allows for retraction of guidewire 28 after implantation of shunt 28).
Horvath ‘175 demonstrates how to deploy an implant with both an automated (¶ [0071] FIGS. 3-6, motors 44, 46 and 48 are housed near the proximal end of implantation apparatus 10; ¶ [0082], FIGS. 10 and 11, a plurality of stepper motors 230(a), (b) and (c) are carried by handheld implantation apparatus); and manually actuated interface (¶ [0088] FIGS. 13 and 14 illustrate another embodiment of a handheld implantation apparatus 130 that likewise utilizes mechanical means for advancing). A skilled artisan would have been able to modify Horvath with Horvath ‘175’s manually controlled and outwardly extending trigger by substituting Horvath’s motorized interface with Horvath ‘175’s manually controlled dials or wheels. One would be motivated to modify Horvath with Horvath ‘175’s manually controlled trigger so that the system can operate without electricity and/or to reduce its cost. Therefore, it would have been obvious to modify Horvath with Horvath ‘175’s manually controlled trigger in order to actuate a glaucoma implant tool with another known structure.
Horvath and Horvath ‘175 teach the invention substantially as claimed by Applicant but do not explicitly disclose an implant comprising a visual aid. De Juan discloses methods and devices for use in treating glaucoma (¶ [0003, [0008], [0019]);
including an ocular implant delivery system comprising: a generally elongated ergonomic outer housing (¶ [0109] FIG. 5 shows an exemplary delivery system 510 … The delivery system 510 includes a handle component 515);
an elongated insertion sleeve (¶ [0110] The delivery component 520 also includes a shunt deployment or advancing structure 530 positioned on a proximal end of the applier 525);
an implant pusher tube and an implant supported on the insertion sleeve (¶ [0113], In this manner, the advancing structure 530 can be used to push the shunt 105 in the distal direction and off of the applier 525 during delivery);
the implant comprising a visual aid positioned at a proximal side of the implant (¶ [0094], the shunt can have one or more visual, tomographic, echogenic, or radiopaque markers 112 that can be used to aid in placement using any of the devices referenced above tuned to its applicable marker system … Any marker can be placed anywhere on the device to provide sensory feedback to the user on real-time placement, confirmation of placement or during patient follow up); and
a manually controlled trigger (¶ [0113] In this regard, the handle component 515 includes an applier control 540 that can be actuated to cause the applier 525 to extend in length in the distal direction or to retract in the opposite direction (proximal direction).).
De Juan provides feedback to a surgeon during a delivery procedure in order to more accurately position the implant (¶ [0094], In using the markers to properly place the implant, the shunt is inserted in the suprachoroidal space, until the marker is aligned with a relevant anatomic structure, for example, visually identifying a marker on the anterior chamber portion of the shunt that aligns with the trabecular meshwork, or scleral spur, such that an appropriate length of the shunt remains in the anterior chamber … confirmation of placement or during patient follow up).
One would be motivated to modify Horvath and Horvath ‘175 with De Juan’s visual aid since Horvath calls for a visual indicator on the delivery system (¶ [0013] Devices of the invention may include an indicator that provides feedback to an operator as to the state of the deployment mechanism … a visual indicator, an audio indicator, or a tactile indicator; ¶ [0051], Housing 101 further includes a slot 106 through which an operator, such as a surgeon, using the device 100 may view an indicator 107 on the deployment mechanism 103). Horvath also calls for visually monitoring the delivery system and implant during the procedure (¶ [0050], In other embodiments, a goniolens is used to visualize advancement of the device within the eye). Therefore, it would have been obvious to modify Horvath and Horvath ‘175 with De Juan’s visual aid in order to more accurately position the implant during a delivery procedure.
Regarding claims 35, 37 and 39, Horvath discloses a method wherein the implantation site is in a suprachoroidal space formed between a choroid and a sclera (¶ [0071], Such a pre-bend allows the hollow shaft 104 to follow the scleral spur down along the sclera in a self-guided manner to the suprachoroidal space; ¶ [0082], At this point, a distal portion of the shunt 115 has been deployed and resides in the suprachoroidal space);
the implantation site is in a fibrous attachment zone adjacent a scleral spur (¶ [0045], The hollow shaft 104 is flexible and pre-bent to follow the scleral spur down along the sclera upon extension of the hollow shaft 104 from the sleeve 130; ¶ [0071], Such a pre-bend allows the hollow shaft 104 to follow the scleral spur down along the sclera in a self-guided manner to the suprachoroidal space);
further comprising separating iris processes away from a scleral spur with the distal end of the delivery device until the implantation site is formed (¶ [0019], FIG. 3E shows a deployment device in an insertion configuration after the protrusion has caused the device to deflect off of the iris and slide along the iris and be fit into an anterior chamber of an eye; ¶ [0049], the substantially flat bottom portion of the protrusion 131 causes the sleeve 130 to deflect off the iris 144 and proceed in a direction parallel to the iris 144 until the protrusion 131 is fit within the anterior chamber angle 143 of the eye 140 (FIGS. 3D and 3E)).
Regarding claim 36, Horvath and Horvath ‘175 do not deliver the implant to the supraciliary space. De Juan discloses a method wherein the implantation site is in a supraciliary space formed between a ciliary body and a choroid (¶ [0008], By guiding fluid directly into the supraciliary or suprachoroidal space rather than to the surface of the eye, complications commonly encountered with conventional glaucoma surgery should be avoided; ¶ [0106] The shunt 105 has a column strength sufficient to permit the shunt 105 to be inserted into suprachoroidal space such that the distal tip of the shunt 105 tunnels through the eye tissue (such as the ciliary body) without structural collapse or structural degradation of the shunt 105; ¶ [0135] During delivery of the shunt 105 … another set of holes 1010 aligns with structures proximal to the suprachoroidal space, such as structures in the ciliary body or the anterior chamber of the eye; ¶ [0149] The applier 525 is continuously advanced into the eye, via the trabecular meshwork and the ciliary body, until the distal tip is located at or near the suprachoroidal space such that a first portion of the shunt 105 is positioned within the suprachoroidal space; ¶ [0154] FIG. 21 shows the shunt 105 implanted in the eye so as to provide a fluid pathway between the anterior chamber AC and the suprachoroidal space SS … the distal tip of the applier and/or the shunt penetrates the tissue and forms a tunnel through the eye tissue, initially the ciliary body).
De Juan demonstrates that the supraciliary space is also an acceptable choice for an implantation site. One would be motivated to modify Horvath and Horvath ‘175 with De Juan’s supraciliary space location to divert aqueous humor to a known drainage pathway. Therefore, it would have been obvious to modify Horvath and Horvath ‘175 with De Juan’s supraciliary space location in order to drain aqueous humor through another acceptable drainage path.
Claims 21-28 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Horvath and Horvath ‘175 in view of Burns; Thomas W. et al. (US 20080228127 A1) with incorporation of Tu, Hosheng et al. (US 20050271704 A1).
Regarding claim 21, Horvath discloses an ocular implant delivery system (¶ [0002], devices and methods for implanting a shunt in the suprachoroidal space of an eye; ¶ [0006], [0042], [0043], FIG. 1A … shunt deployment device 100);
comprising: a generally elongated ergonomic outer housing (¶ [0043], FIG. 1A deployment device 100 includes a generally cylindrical body or housing 101, however, the body shape of housing 101 could be other than cylindrical. Housing 101 may have an ergonomical shape, allowing for comfortable grasping by an operator);
an elongated insertion sleeve partially disposed in the outer housing and having a lumen (¶ [0045] Distal portion 101b includes a capsule 129 and an outer stiff hollow sleeve 130; ¶ [0045], The hollow sleeve 130 is configured for insertion into an eye and to extend into an anterior chamber of an eye); and
an exposed distal portion extending out of a distal end of the outer housing (¶ [0048], FIG. 3A shows device 100 in an insertion configuration and inserted into an eye 140. In this figure, protrusion 131 at the distal end of the sleeve 130 has been advanced across the anterior chamber 141 to the sclera 142);
an implant pusher tube partially disposed in and extending outwardly from the distal end of the outer housing, passing through at least a portion of the lumen of the insertion sleeve (¶ [0062] FIG. 8 shows a cross-sectional view of deployment mechanism 103 … The pusher component 118 extends through the proximal portion 109 of the deployment mechanism 103 and extends into a portion of hollow shaft 104);
an implant supported within the distal portion of the insertion sleeve and in line with a distal end of the implant pusher tube (¶ [0057] Generally, hollow shaft 104 is configured to hold an intraocular shunt 115; ¶ [0063], FIG. 9A shows deployment device 100 in a pre-deployment or insertion configuration. In this configuration, shunt 115 is loaded within hollow shaft 104 (FIG. 9B)); and
a trigger mechanically coupled to the outer housing such that actuation of the trigger deploys the implant into an implantation location within an eye (¶ [0062], FIG. 8 shows a cross-sectional view of deployment mechanism 103 … Member 114b is connected to a pusher component 118 … Movement of member 114b engages pusher 118 and results in pusher 118 advancing within hollow shaft 104).
Horvath lacks a manually controlled trigger that extends outside the outer housing. Horvath ‘175 discloses methods, systems, apparatus and shunts for treating glaucoma (¶ [0008], [0011], [0018]);
including a manually controlled trigger, an actuatable portion of which extends outside an outer housing, mechanically coupled to the outer housing such that actuation of the trigger deploys an implant into an implantation location within an eye (¶ [0088], FIG. 13 … A thumbwheel 136 is rotatable and coupled to an internal screw … such that turning of thumbscrew 136 effects axial movement of needle assembly 134; ¶ [0089], FIG. 13, a second thumbwheel 142 … A rotation of thumbwheel 142 allows for retraction of guidewire 28 after implantation of shunt 28).
Horvath ‘175 demonstrates how to deploy an implant with both an automated (¶ [0071], [0082]); and manually actuated interface (¶ [0088]). Regarding the rationale and motivation to modify Horvath with Horvath ‘175’s manually controlled and outwardly extending trigger, see the discussion of claim 34 above.
Horvath and Horvath ‘175 lack a non-linear distal portion and a visual aid. Burns discloses a method and system for reducing intraocular pressure (¶ [0003], [0025], [0030], [0079], [0141] FIG. 4 illustrates one embodiment of a shunt 130; ¶ [0170] FIG. 15 illustrates one embodiment of a delivery instrument 830);
comprising: a generally elongated outer housing (¶ [0181] FIG. 21 shows another embodiment of a system … The mechanism may be incorporated into a handle, such as the push-pull controls in the handles of electrophysiology catheters known in the art);
an elongated insertion sleeve partially disposed in the outer housing and having a lumen (¶ [0170] FIG. 15 … A wall 838 of the delivery instrument 830); and
a non-linear exposed distal portion extending out of a distal end of the outer housing (¶ [0174] The delivery instrument/shunt assembly must be passed between the iris and the cornea to reach the iridocorneal angle. Therefore, the height of the delivery instrument/shunt assembly (dimension 1095 in FIG. 17) preferably is less than about 3 mm, and more preferably less than 2 mm; ¶ [0176] The overall geometry of the system makes it advantageous that the delivery instrument 1130 incorporates a distal curvature 1140, as shown in FIG. 17, or a distal angle 1150, as shown in FIG. 18. The distal curvature (FIG. 17) is expected to pass more smoothly through the corneal or scleral incision at the limbus; ¶ [0181] FIG. 21 shows another embodiment … The curved shaft of a delivery instrument 2100 can be hollow; ¶ [0186] FIG. 25 shows another embodiment … the shunt 2200 is mounted on a curved or angled shaft 2250);
an implant pusher tube partially disposed in and extending outwardly from the distal end of the outer housing and passing through at least a portion of the lumen of the insertion sleeve (¶ [0170] FIG. 15 … Positioned within the lumen 834 is preferably a pusher tube 836 that is axially movable within the lumen 834, as indicated by the arrows A);
an implant supported within the distal portion of the insertion sleeve and in line with a distal end of the implant pusher tube (¶ [0170] FIG. 15 … A wall 838 of the delivery instrument 830 preferably extends beyond pusher tube 836 to accommodate placement within the lumen 834 of a shunt 840);
the implant comprising a visual aid (¶ [0088] The body of the shunt can include at least one surface irregularity. The surface irregularity can comprise, for example, a ridge, groove, relief, hole, or annular groove. The surface discontinuities or irregularities can also be formed by barbs or other projections, which extend from the outer surface of the shunt, to inhibit migration of the shunt from its implanted position; ¶ [0094], The shunt can have a substantially constant cross-sectional shape through most of the length of the shunt, or the shunt can have portions of reduced or enlarged cross-sectional size (e.g., diameter), or cylindrical channels, e.g., annular grooves, disposed on the outer surface between the proximal end and the distal end; ¶ [0208], The shunts 4200 illustrated in FIGS. 41A-J include a retention feature(s) to engage the fibrous muscle adhesion 4210 (FIG. 41A) … The feature can also give the surgeon tactile feedback as to the ideal axial positioning of the device. Such a feature can be in the form of a circumferential groove, a protruding anchor, a flange, etc.; ¶ [0209], As such, the barbs 4234, 4236 form an annular groove about the shunt 4200c); and
a trigger that deploys the implant into an implantation location within an eye (¶ [0121] Some embodiments can include a spring-loaded or stored-energy pusher system. The spring-loaded pusher preferably includes a button … When the user pushes the button, the rod is disengaged … thereby advancing the pusher forward; ¶ [0130] The shunts may be placed using an applicator, such as a pusher, or they may be placed using a delivery instrument having energy stored in the instrument, such as disclosed in U.S. Patent Publication 2004/0050392, filed Aug. 28, 2002, the entirety of which is incorporated herein by reference; ¶ [0170] FIG. 15 … As the pusher tube 836 is advanced, the shunt 840 is also advanced).
Regarding the visual aid being positioned at a proximal side of the implant, Burns incorporates Tu by reference (¶ [0212], the shunts disclosed herein may be used in combination with trabecular bypass shunts … described in U.S. Patent Publication 2005/0271704, filed Mar. 18, 2005, the entirety of which is incorporated herein by reference and made a part of this specification and disclosure).
Tu discloses an ocular implant (¶ [0002], shunt-type stenting devices; ¶ [0041], an implant for treating glaucoma; ¶ [0156] FIG. 3 … trabecular stenting device 30);
comprising a visual aid, wherein the visual aid is positioned at a proximal side of the implant (¶ [0161] In the illustrated embodiment of FIGS. 3-9, and as best seen in the top view of FIG. 5, the seat top surface 44 comprises fiducial marks or indicia 48. These marks or indicia 48 facilitate and ensure proper orientation and alignment of the stent 30 when implanted in the eye 10. The marks or indicia 48 may comprise visual differentiation means such as color contrast or be in the form of ribs, grooves, or the like. Alternatively, or in addition, the marks 48 may provide tactile sensory feedback to the surgeon by incorporating a radiopaque detectable or ultrasound imaginable substrate at about the mark 48; ¶ [0186] As indicated above, fiducial marks or indicia and/or predetermined shapes of the snorkel seat 38 allow for proper orientation of the blade 34 and also the output channels 45a and respective ports 56a within Schlemm's canal; ¶ [0221], stent 30g (FIG. 34) … A final twist of the applicator by the surgeon and observation of suitable fiducial marks, indicia or the like ensure proper alignment of the side ports 56g with Schlemm's canal 22).
Burns includes a curved or angled portion in order for the insertion sleeve to pass more easily through an angled portion of the anterior chamber (¶ [0132], The overall geometry of the system makes it advantageous that the delivery instrument incorporates a distal curvature, or a distal angle; ¶ [0144], the shunt 130 is preferably advanced through the tissue within the anterior chamber angle during implantation; ¶ [0175] The suprachoroidal space between the choroid and the sclera generally forms an angle 1110 of about 55 degrees … are features to consider in the geometrical design of the delivery instrument/shunt assembly; ¶ [0176], The distal curvature (FIG. 17) is expected to pass more smoothly through the corneal or scleral incision at the limbus). One would be motivated to modify Horvath and Horvath ‘175 with Burns’s non-linear distal portion since Horvath seeks to deliver an implant in the anterior chamber’s angled section and warns against an improper delivery angle (¶ [0048], FIG. 3A shows protrusion 131 fitted within the anterior chamber angle 143 of the eye 140. If sleeve 130 enters the anterior chamber 141 at too shallow an angle, i.e., the protrusion 131 hit the sclera 142 above the anterior chamber angle 143, the angled top portion of the protrusion 131 causes the sleeve 130 to slide down the sclera 142 (direction of arrow) until the protrusion 131 is fit within the anterior chamber angle 143 of the eye 140 (FIGS. 3B and 3C)). Therefore, it would have been obvious to modify Horvath and Horvath ‘175 with Burns’s non-linear distal portion in order to more easily deliver a drainage implant in the anterior chamber’s angle.
Burns anchors an implant and also provides feedback during a delivery procedure (¶ [0208], The feature can also give the surgeon tactile feedback as to the ideal axial positioning of the device). Although Burns does not explicitly describe the various grooves, ridges or barbs as a visual aid, Burns delivers the implant with a gonioscope, which magnifies ocular tissues sufficiently to view the retention feature (¶ [0119], The placement and implantation of the shunt can be performed using a gonioscope or other conventional imaging equipment). Tu expressly acknowledges the benefits of a visual aid (¶ [0036], proper orientation and alignment of the device during implantation).
Similarly, Horvath visualizes the delivery system and implant during the procedure (¶ [0050], In other embodiments, a goniolens is used to visualize advancement of the device within the eye). One would be motivated to modify Horvath and Horvath ‘175 with Burns’s or Tu’s visual aid to more accurately position the implant during a delivery procedure. Therefore, it would have been obvious to modify Horvath and Horvath ‘175 with Burns’s or Tu’s visual aid in order to more accurately deploy the implant.
Regarding claims 22, 23, 25 and 26, Horvath and Horvath ‘175 lack a curved or nonlinear insertion sleeve. Burns discloses a delivery system wherein the distal portion of the insertion sleeve has a first radius of curvature that provides proper alignment of the implant for suprachoroidal implantation of the implant; wherein the distal portion of the insertion sleeve has a radius of curvature that is between 0.4 inches and 2.2 inches (¶ [0114], The distal curvature of the delivery instrument may be characterized as a radius of approximately 10 to 30 mm, and preferably about 20 mm; ¶ [0177] The distal curvature 1140 of delivery instrument 1130 may be characterized as a radius of approximately 10 to 30 mm, and preferably about 20 mm; [[10 mm ≈ 0.39 inches; 30 mm ≈1.18 inches);
the implant is curved to have proper curvature and alignment for suprachoroidal implantation (¶ [0097], In other embodiments, at least a portion of the shunt is curved; ¶ [0176], The distal curvature (FIG. 17) is expected to pass more smoothly through the corneal or scleral incision at the limbus. However, the shunt preferably is curved or flexible in this case; ¶ [0186] FIG. 25 … The shunt 2200 can be curved with approximately the same radius as the delivery device, so that the shunt can be relatively stiff and still slide along the shaft);
the nonlinear exposed distal portion of the insertion sleeve and a nonlinear distal portion of the implant have matching curvatures (¶ [0186] FIG. 25 … The shunt 2200 can be curved with approximately the same radius as the delivery device, so that the shunt can be relatively stiff and still slide along the shaft).
Burns directs the sleeve’s distal tip towards an implantation site in the anterior chamber angle (¶ [0132], [0144], [0175], [0176]). Regarding the rationale and motivation to modify Horvath and Horvath ‘175 with Burns’s nonlinear portions, see the discussion of claim 34 above.
Regarding claims 24, 27, 28 and 32, Horvath discloses a delivery system wherein the implant is made of a flexible material (¶ [0090] Shunts of the invention are composed of a material that is compatible with an elasticity modulus of tissue surrounding the shunt … Exemplary materials includes biocompatible polymers, such as polycarbonate, polyethylene, polyethylene terephthalate, polyimide, polystyrene, polypropylene, poly(styrene-b-isobutylene-b-styrene), or silicone rubber);
the implant further comprises a therapeutic agent or drug (¶ [0057], If a gelatin shunt is used, the shunt is generally wetted inside the hollow shaft 104 with a balanced salt solution … or a steroid or other drug prior to implantation; ¶ [0073] At this point, an amount of BSS/steroid or other drug can be optionally injected through the hollow shaft and implant into a lower end of the target space; ¶ [0136], The pharmaceutical and/or biological agent may coat or impregnate an entire exterior of the shunt, an entire interior of the shunt, or both … Darouiche (U.S. Pat. Nos. 7,790,183; 6,719,991; 6,558,686; 6,162,487; 5,902,283; 5,853,745; and 5,624,704) and Yu et al. (U.S. patent application serial number 2008/0108933). The content of each of these references is incorporated by reference herein its entirety);
the therapeutic agent comprises an anti-angiogenesis agent (¶ [0138], Exemplary agents include anti-mitotic pharmaceuticals such as Mitomycin-C or 5-Fluorouracil, anti-VEGF (such as Lucintes, Macugen, Avastin, VEGF or steroids));
the implant is prevented from backwards movement by contact between a proximal end of the implant and the distal end of the implant pusher tube (¶ [0063], The shunt 115 is loaded into hollow shaft 104 such that the shunt abuts pusher component 118 within hollow shaft 104).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Horvath, Horvath ‘175 and Burns in view of Burns ‘870, Thomas W. et al. (US 20040147870 A1).
Regarding claim 31, Horvath, Horvath ‘175 and Burns lack sterile packaging. Burns ‘870 discloses devices and methods for reducing intraocular pressure, including a delivery system provided in a sterile packaging for single-use operation (¶ [0130] FIG. 55D is a top view of one embodiment of a kit, including one stent/applicator unit with one or more additional stents stored in a cartridge loader, all packaged in one sterile package; ¶ [0131] FIG. 55E is a top view of one embodiment of a kit, including one applicator with two or more stents stored in a cartridge loader, all packaged in the same sterile package; ¶ [0349] FIG. 55D shows a top view of one embodiment of a device kit including one stent/applicator unit with one or more additional stents 305 stored in a cartridge loader 309, all packaged in the same sterile package 308, wherein each unit contains an applicator 304 and one stent 305; ¶ [0350] FIG. 55E shows a top view of one embodiment of a device kit including one applicator 304 with two or more stents 305 stored in a cartridge loader 309, all packaged in the same sterile package 310, wherein each unit contains an applicator 304 and one stent 305).
Burns ‘870 stores a kit for delivering a glaucoma implant in sterile packaging for convenience and to prevent contamination. One would be motivated to modify Horvath, Horvath ‘175 and Burns with Burns ‘870’s sterile packaging so that a surgeon can access all needed supplies from a single location, and also to reduce the risk of infection. Therefore, it would have been obvious to modify Horvath, Horvath ‘175 and Burns with Burns ‘870’s sterile packaging in order to supply surgical equipment in a single convenient location.
Claims 29 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Horvath, Horvath ‘175 and Burns in view of Weber, David A. et al. (US 20050203542 A1).
Regarding claims 29 and 33, Horvath, Horvath ‘175 and Burns lack a reuse prevention structure or trigger safety device. Weber discloses a delivery system for an ocular implant including an outer housing (¶ [0002], methods and apparatus for delivering solid or semi-solid materials into the eye; ¶ [0008], [0038], FIGS. 1-9. As shown, implant delivery apparatus 10 includes external housing 20 … Cannula 40, having beveled tip 41, extends from the nose cone. Ejector button 50 extends through opening 52 of the housing);
wherein the outer housing further comprises reuse prevention structures designed to limit use of the delivery system to a single use (¶ [0049] Button 50 also includes tab 57, which is engageable with tab slot 58 of the housing. The tab includes a detent which, when engaged in slot 58 will provide an audible click, signaling the user that the implant has been deployed, and will also retain the actuating lever in a locked, depressed condition, after deployment of the implant; ¶ [0056] FIG. 12A … When the lever is fully depressed and the implant ejected, tab 257 engages latch 258, thereby locking the assembly into a depressed, post-ejection, condition; ¶ [0058], The inclusion of locking mechanisms, such as tab 57 and slot 58 locking mechanism of the apparatus of FIGS. 1-9, or the lock tab mechanism of the apparatus of FIGS. 10-11, or the tab-latch mechanism of the apparatus of FIGS. 12A-12B, guards against backflow of eye fluid into the cannula after deployment of the implant);
further comprising a trigger safety device mechanically engaged with the trigger such that actuation of the trigger cannot occur while the trigger safety device is engaged (¶ [0078] Loaded apparatus according to the invention can be packaged to include a safety cap … The button or other depression mechanism of the apparatus can also include a notch which receives the rim of the safety cap. In this configuration, the safety cap will then also operate to guard against unintentional depression of the button or other depression mechanism and ejection of the implant).
Weber prevents the system from being used a second time (¶ [0058], These locking mechanisms can further be configured such that the engagement between the two is irreversible, which prevents reuse of the apparatus. This is advantageous, e.g., if a single-use apparatus is desired). Weber’s trigger safety device prevents a user from inadvertently deploying the implant.
One would be motivated to modify Horvath, Horvath ‘175 and Burns with Weber’s reuse prevention structure in order to minimize the risk that a user will try to reuse the insertion sleeve on a second site or a second patient. A skilled artisan would have been motivated to modify Horvath, Horvath ‘175 and Burns with Weber’s trigger safety device in order to avoid accidentally deploying the implant. Therefore, it would have been obvious to modify Horvath, Horvath ‘175 and Burns with Weber’s reuse prevention structure in order to minimize the risk of contaminating another patient or inadvertently deploying the implant.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Horvath, Horvath ‘175 and Burns in view of De Juan, Jr.; Eugene et al. (US 20110028883 A1).
Regarding claim 40, Horvath, Horvath ‘175 and Burns lack a visual aid comprising a radiopaque marker. De Juan discloses a visual aid comprising a radiopaque marker (¶ [0094] The shunt 105 can include one or more features that aid in properly positioning the shunt 105 in the eye. For example, the shunt can have one or more visual, tomographic, echogenic, or radiopaque markers 112 that can be used to aid in placement using any of the devices referenced above tuned to its applicable marker system).
De Juan enables a surgeon to more accurately position an implant during a deployment procedure. Regarding the rationale and motivation to modify Horvath, Horvath ‘175 and Burns with De Juan’s visual marker, see the discussion of claim 21 above.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Horvath, Horvath ‘175 and Burns in view of McKenna; Robert H. et al. (US 20060253039 A1).
Regarding claim 41, Horvath, Horvath ‘175 and Burns lack a trigger safety member. McKenna discloses a surgical tool (¶ [0005], an anastomotic ring applier device; ¶ [0031], FIG. 1 depicts an applier 10);
comprising a sliding manually controlled trigger (¶ [0035], FIGS. 6-11 and 13-19 … first deployment actuator 34 is operable to actuate proximal fingers 60 of ring deployment mechanism 26; and second deployment actuator 36 is operable to actuate distal fingers 62 of ring deployment mechanism 26);
further comprising a trigger safety member mechanically engaged with the manually controlled trigger; and positioned on a proximal side of the manually controlled trigger (¶ [0039] To prevent inadvertent deployment of ring deployment mechanism 26, applier 10 of the present example is provided with a locking element 52 … In FIGS. 1, 5-6, 10, 13-15, and 19, locking element 52 is shown in a locked position preventing actuating movement of first actuator 34 and second actuator 36; ¶ [0049], With ring deployment mechanism 26 exposed, and with locking element 52 depressed, second actuator 36 may be actuated).
McKenna prevents inadvertent actuation of a surgical handpiece (¶ [0039]], [0040]). One would be motivated to modify Horvath, Horvath ‘175 and Burns with McKenna’s trigger safety member to ensure that a user actuates the device only when intended. Therefore, it would have been obvious to modify Horvath, Horvath ‘175 and Burns with McKenna’s trigger safety member in order to avoid inadvertent actuation.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Horvath, Horvath ‘175 and De Juan in view of Weber, David A. et al. (US 20050203542 A1).
Regarding claim 38, Horvath, Horvath ‘175 and De Juan lack a trigger safety device. Weber discloses a method further comprising removing a trigger safety device before actuating a trigger (¶ [0078], The button or other depression mechanism of the apparatus can also include a notch which receives the rim of the safety cap).
Weber reduces the risk of accidentally deploying an implant. Regarding the rationale and motivation to modify Horvath, Horvath ‘175 and De Juan with Weber’s trigger safety device, see the discussion of claim 33 above.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 21 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 14 of Rangel-Friedman; Gary et al. (US 11523938 B2) in view of De Juan, Jr.; Eugene et al. (US 20110028883 A1).
Regarding pending claim 21, Rangel-Friedman claims all limitations in patented claim 14, namely an ocular implant delivery system (claim 14, An ocular implant delivery system);
comprising: a generally elongated ergonomic outer housing (claim 14, a generally elongated outer housing that is contoured);
an elongated insertion sleeve partially disposed in the outer housing and having a lumen (claim 14, an elongated insertion needle partially disposed in the outer housing … a lumen of the elongated insertion needle); and
a non-linear exposed distal portion extending out of a distal end of the outer housing (claim 14, a non-linear exposed distal portion);
an implant pusher tube partially disposed in and extending outwardly from the distal end of the outer housing, passing through at least a portion of the lumen of the insertion sleeve (claim 14, an implant pusher tube extending through a lumen of the elongated insertion needle);
an implant supported within the distal portion of the insertion sleeve and in line with a distal end of the implant pusher tube (claim 14, wherein, in use, a distal end of the pusher tube is adapted to react against a proximal end of an implant loaded on to the trocar as the trocar is being retracted within the housing to deliver the implant); and
a manually controlled trigger, an actuatable portion of which extends outside the outer housing (claim 1, a manually controlled trocar trigger, an actuatable portion of which extends outside the outer housing);
such that actuation of the trigger deploys the implant into an implantation location within an eye (claim 14, a trocar trigger mechanically coupled to the trocar such that movement of the trocar trigger towards a proximal end of the housing retracts the trocar toward the housing).
Rangel-Friedman does not claim an implant comprising a visual aid. De Juan discloses a visual aid comprising a radiopaque marker, wherein the visual aid is positioned at a proximal side of the implant (¶ [0094] The shunt 105 can include one or more features that aid in properly positioning the shunt 105 in the eye. For example, the shunt can have one or more visual, tomographic, echogenic, or radiopaque markers 112 that can be used to aid in placement using any of the devices referenced above tuned to its applicable marker system).
De Juan enables a surgeon to more accurately position an implant during a deployment procedure. Regarding the rationale and motivation to modify Rangel-Friedman’s claims with De Juan’s visual marker, see the discussion of claim 21 above.
Response to Arguments
Applicant’s arguments filed 11 March 2026 regarding the rejection of claims 21-29 and 31-40 as amended, under 35 USC § 103 over Horvath, Horvath ‘175, De Juan, Burns, Weber and Burns ‘870, have been fully considered and are partly persuasive. After further consideration, the amended claim 21 and its dependents are rejected on new grounds under 35 USC § 103 over Horvath and Horvath ‘175 in view of Burns with incorporation of Tu (see above).
New claim 41 is rejected over Horvath, Horvath ‘175, Burns and McKenna.
Applicant submits that Horvath and Horvath '175 fail to disclose or suggest this feature (remarks p. 6). Applicant asserts that neither Horvath nor Horvath '175 teaches or suggests a visual aid that remains with the implant after deployment, nor positioning such a visual aid on a proximal side of the implant (remarks p. 6).
Examiner responds that Burns’s incorporated reference to Tu is cited in the new grounds of rejection as teaching a visual aid on a proximal side of an ocular implant.
For reasons similar to those discussed above with reference to independent Claim 21, Applicant submits that Claim 34 is patentable and requests allowance of Claim 34 (remarks p. 7). Examiner replies that De Juan is cited in claim 34 as teaching a visual aid positioned at any location on an ocular implant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Boudreaux; Chad P. US 20110155780 A1
Callede; David et al. US 20130116595 A1
Examiner has applied new grounds of rejection not necessitated by amendment. Therefore, this Office Action is Non-Final.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781