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 21-28,32,34-37,39-40 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Burns; Thomas W. et al. (US 20080228127 A1) in view of De Juan, Jr.; Eugene et al. (US 20110028883 A1).
Regarding claim 21, Burns discloses an ocular implant delivery system (¶ [0003], [0024], [0025], a method for reducing intraocular pressure in an eye; ¶ [0026] An ocular implant; ¶ [0034], a system for treating glaucoma);
comprising: an elongated insertion sleeve having a lumen (¶ [0170] FIG. 15 illustrates one embodiment of a delivery instrument 830; ¶ [0172] FIG. 17 … another embodiment of a delivery instrument 1130); and
a non-linear exposed distal portion extending out of a distal end of the outer housing (¶ [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);
an implant pusher tube passing through at least a portion of the lumen of the insertion sleeve (¶ [0170], 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 (¶ [0141] FIG. 4 illustrates one embodiment of a shunt 130; ¶ [0149], FIG. 5 illustrates a shunt 230; ¶ [0151] FIG. 6 depicts embodiments of a shunt 330; ¶ [0153] FIGS. 7-8 depict embodiments of another shunt 430; ¶ [0170] FIG. 15 … shunt 840);
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);
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 the implant into an implantation location within an eye (¶ [0181] FIG. 21 … The proximal end of the delivery instrument is not shown, but provides for a sliding mechanism to advance and retract the stylet 2120 by the operator. The mechanism may be incorporated into a handle, such as the push-pull controls in the handles of electrophysiology catheters known in the art).
Burns does not explicitly disclose an elongated ergonomic outer housing or a visual aid that measures a proper depth for placing the implant. De Juan discloses methods and devices for use in treating glaucoma (¶ [0003], [0008], [0085], [0092] FIG. 3A shows a first embodiment of the shunt 105);
comprising: a generally elongated ergonomic outer housing (¶ [0109] FIG. 5 … The delivery system 510 includes a handle component 515);
an implant pusher tube partially disposed in and extending outwardly from the distal end of the outer housing (¶ [0110], The advancing structure 530 can be an elongated tube);
an implant in line with a distal end of the implant pusher tube (¶ [0110], The delivery system 510 can be actuated to achieve relative, sliding movement between the advancing structure 530 and the applier 525. For example, the advancing structure 520 can be moved in the distal direction (as represented by the arrow 532), while the applier 525 remains stationary to push or otherwise advance the shunt 105 along the applier 525 for delivery of the shunt 105 into the eye);
the implant comprising a visual aid, wherein the visual aid is positioned at a proximal side of the implant on an elongate body of the implant and configured to enable determination of proper depth of implant placement during deployment 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; ¶ [0135], The shunt can have visual markers along its length; ¶ [0151] As mentioned, the delivery device 510 and/or the shunt 105 can be equipped with navigational aides, such as radiopaque markers, or means to enable ultrasonic visualization; ¶ [0177], Further, the markers can be laser printed or etched on the shunt device to show the amount of shunt deployed in the suprachoroidal space, or the amount by which the shunt device should be allowed to protrude into the anterior chamber); 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 (¶ [0119] FIG. 6B … The handle component 515 includes an actuator comprised of a knob 550 that can slide relative to the handle component 515. The knob 550 serves as an actuator that controls relative, sliding movement between the advancing member 530 and the applier 525).
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 Burns with De Juan’s elongated ergonomic outer housing in order to support the insertion sleeve since Burns suggests to use an existing handle from other instruments (¶ [0181], The mechanism may be incorporated into a handle, such as the push-pull controls in the handles of electrophysiology catheters known in the art).
One would be motivated to modify Burns with De Juan’s visual aid since Burns optically monitors the implant while deploying it (¶ [0119], The placement and implantation of the shunt can be performed using a gonioscope or other conventional imaging equipment). A skilled artisan would have been able to modify Burns with De Juan’s visual aid by printing, etching or embedding marks at regular intervals along the implant. Therefore, it would have been obvious to modify Burns with De Juan’s visual aid in order to more reliably maneuver the implant towards a desired location.
Regarding claim 35, Burns discloses a method of implanting an ocular implant within an eye (¶ [0003], [0024], [0025], a method for reducing intraocular pressure in an eye; ¶ [0026] An ocular implant; ¶ [0034], a system for treating glaucoma);
the method comprising: inserting a distal end of a delivery device loaded with an implant within an insertion sleeve of the delivery device (¶ [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; ¶ [0172] FIG. 17 … another embodiment of a delivery instrument 1130);
through a pre-formed corneal incision into an anterior chamber of an eye (¶ [0116], Alternatively, a trocar, scalpel, or similar instrument can be used to pre-form an incision in the eye tissue before passing the shunt into such tissue);
advancing a distal end of the delivery device across the anterior chamber to an anterior chamber angle adjacent an implantation site (¶ [0119] Once into the anterior chamber, a delivery instrument can be advanced from the insertion site transocularly into the anterior chamber angle and positioned at a location near the scleral spur);
advancing the distal end of the delivery device into the implantation site (¶ [0176], The distal curvature (FIG. 17) is expected to pass more smoothly through the corneal or scleral incision at the limbus);
actuating a manually controlled trigger, an actuatable portion of which extends outside the outer housing, such that the implant reacts against a distal end of an implant pusher tube of the delivery device as the trigger is actuated (¶ [0181] FIG. 21 … The proximal end of the delivery instrument is not shown, but provides for a sliding mechanism to advance and retract the stylet 2120 by the operator. The mechanism may be incorporated into a handle, such as the push-pull controls in the handles of electrophysiology catheters known in the art);
thus deploying the implant into the implantation site (¶ [0120], When the shunt is brought into position adjacent the tissue in the anterior chamber angle, the pusher tube is advanced axially toward the open distal end of the delivery instrument); and
removing the delivery device from the eye (¶ [0170], the delivery instrument 830 is retracted, leaving the shunt 840 in the eye tissue; ¶ [0171], The delivery instrument 930 is then removed from the eye).
Burns lacks a visual aid. De Juan discloses methods and devices for use in treating glaucoma (¶ [0003], [0008], [0085], [0092] FIG. 3A shows a first embodiment of the shunt 105);
comprising: inserting a distal end of a delivery device loaded with an implant through a pre-formed corneal incision into an anterior chamber of an eye (¶ [0142], FIG. 15A, the delivery device 510 is positioned such that the distal tip of the applier 525 or the shunt 105 itself can penetrate through the cornea … The applier 525 can be used to make the incision or a separate cutting device can be used);
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 (¶ [0147], FIG. 16 … The shunt 105 which is mounted on the applier 525, is shown approaching the suprachoroidal space from the anterior chamber. The distal tip of the applier 525 moves along a pathway such that the distal tip is positioned at the scleral spur with the curve of the applier 525 aiming the distal tip toward the suprachoroidal space);
actuating a manually controlled trigger, an actuatable portion of which extends outside the outer housing; 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 (¶ [0119] FIG. 6B … The handle component 515 includes an actuator comprised of a knob 550 that can slide relative to the handle component 515. The knob 550 serves as an actuator that controls relative, sliding movement between the advancing member 530 and the applier 525);
wherein the implant comprises a visual aid positioned at a proximal side of the implant on an elongate body of the implant and configured to enable determination of proper depth of implant placement during deployment 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; ¶ [0135], The shunt can have visual markers along its length; ¶ [0151] As mentioned, the delivery device 510 and/or the shunt 105 can be equipped with navigational aides, such as radiopaque markers, or means to enable ultrasonic visualization; ¶ [0177], Further, the markers can be laser printed or etched on the shunt device to show the amount of shunt deployed in the suprachoroidal space, or the amount by which the shunt device should be allowed to protrude into the anterior chamber); and
removing the delivery device from the eye (¶ [0120], As shown in FIG. 6G, the applier 525 can be fully withdrawn into the advancing structure 530 such that the shunt 105 is released from the applier 525).
De Juan provides feedback in order to more accurately position the implant (¶ [0094]). Regarding the rationale and motivation to modify Burns with De Juan’s visual aid, see the discussion of claim 21 above.
Regarding claims 22-25, 27-28, 32, 35-37 and 39-40, Burns discloses a delivery system and method 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 (¶ [0133], the shunt and delivery instrument can be advanced together through the anterior chamber 32 … until the shunt outlet portion is located in the uveoscleral outflow pathway (e.g. exposed to the suprachoroidal space 34 defined between the sclera 38 and the choroid 40); ¶ [0172] FIG. 17 … The ciliary muscle is part of the choroid 1050. The suprachoroidal space 34 is the interface between the choroid and the sclera; ¶ [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; ¶ [0178] FIG. 19 illustrates in cross-section another embodiment of a shunt 2000 that is operable to drain fluid from the anterior chamber to the suprachoroidal space);
wherein the distal portion of the insertion sleeve has a radius of curvature that is between 0.4 inches and 2.2 inches (¶ [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);
wherein the implant is made of a flexible material (¶ [0102] The shunt can further comprise a biodegradable material in or on the shunt … selected from the group consisting of poly(lactic acid), polyethylene-vinyl acetate, poly(lactic-co-glycolic acid), poly(D,L-lactide), poly(D,L-lactide-co-trimethylene carbonate), collagen, heparinized collagen, poly(caprolactone), poly(glycolic acid), and a copolymer);
wherein the implant is curved to have proper curvature and alignment for suprachoroidal implantation (¶ [0133], the shunt and delivery instrument can be advanced together through the anterior chamber 32 from an incision … until the shunt outlet portion is located in the uveoscleral outflow pathway (e.g. exposed to the suprachoroidal space 34 defined between the sclera 38 and the choroid 40); ¶ [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);
wherein the implant further comprises a therapeutic agent or drug (¶ [0101] The body of the shunt can comprise material that includes a therapeutic agent … a drug eluting coating, an antithrombogenic coating, and a lubricious coating … heparin, TGF-beta, an intraocular pressure-lowering drug, and an anti-proliferative agent);
wherein the therapeutic agent comprises an anti-angiogenesis agent (¶ [0136], Exemplary therapeutic agents may include: anti-angiogenesis agents, including VEGF receptor tyrosine kinase inhibitors and anti-vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab (LUCENTIS.RTM.) and bevacizumab (AVASTIN.RTM.), pegaptanib (MACUGEN.RTM.), sunitinib and sorafenib);
wherein 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 (¶ [0120], When the shunt is brought into position adjacent the tissue in the anterior chamber angle, the pusher tube is advanced axially toward the open distal end of the delivery instrument. As the pusher tube is advanced, the shunt is also advanced);
wherein the implantation site is in a suprachoroidal space formed between a choroid and a sclera (¶ [0008], and the term "suprachoroidal space" is to be given its ordinary and customary meaning … and refers without limitation to the portion of the uveoscleral pathway between the choroid and sclera);
wherein the implantation site is in a supraciliary space formed between a ciliary body and a choroid (¶ [0008], As used herein, the term "supraciliary space" is to be given its ordinary and customary meaning … and refers without limitation to the portion of the uveoscleral pathway through the ciliary muscle and between the ciliary body and the sclera);
wherein the implantation site is in a fibrous attachment zone adjacent a scleral spur (¶ [0083] The shunt can be advanced through the ciliary attachment tissue, which lies to the posterior of the scleral spur, during implantation. This tissue typically is fibrous or porous, which is relatively easy to pierce or cut with a surgical device, and lies inward of the scleral spur);
further comprising separating iris processes away from a scleral spur with the distal end of the delivery device until the implantation site is formed (¶ [0119], Using the scleral spur as a reference point, the delivery instrument can be advanced further in a generally posterior direction to drive the shunt into eye tissue at a location just inward of the scleral spur toward the iris);
wherein the visual aid comprises a radiopaque marker (¶ [0151] As mentioned, the delivery device 510 and/or the shunt 105 can be equipped with navigational aides, such as radiopaque markers, or means to enable ultrasonic visualization that assist in proper positioning of the applier and shunt in the eye).
Regarding claim 26, Burns does not explicitly disclose that the nonlinear exposed distal portion of the insertion sleeve and a nonlinear distal portion of the implant have matching curvatures. However, Burns shows an embodiment having a curved implant (¶ [0181] FIG. 21 … The curved shaft of a delivery instrument 2100 can be hollow, and the shunt 2110 can be slidably mounted on the outer diameter of the delivery instrument). The embodiment of Fig. 17 contains an internal implant which implies that the nonlinear distal portion of the insertion sleeve and nonlinear distal portion of the implant have matching curvatures.
Regarding claim 42, Burns does not explicitly disclose that the distal end of the pusher tube is configured to extend out of the distal portion of the insertion sleeve during deployment of the implant. However, Burns describes a pusher tube that can extend variably through the insertion sleeve (¶ [0170], the pusher tube 836 is advanced axially toward the open distal end 832 of the delivery instrument 830. As the pusher tube 836 is advanced, the shunt 840 is also advanced). Burns does not preclude the pusher tube against extending beyond the insertion sleeve, and depicts both of these elements as having an indefinite length (Figs. 2, 3, 15, 17, 21, 25).
Burns discloses a further embodiment comprising a pusher tube that can extend out of the distal portion of the insertion sleeve (¶ [0171] FIG. 16 … When the shunt is properly positioned within the eye tissue, the slider tube 940 is withdrawn to permit the prongs 934 to expand radially outwardly, and the shunt is released from the grip of the prongs 934).
Regarding claim 43, Burns is silent whether about 0.4 mm to about 0.7 mm of the proximal side of the implant extends into an anterior chamber of the eye after deployment of the implant into the implantation site.
The proximal extension length is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The proximal extension length can be adjusted through routine experimentation in order to adequately communicate with the anterior chamber..
Burns describes an overall range for the implant’s length (¶ [0026], the implant comprises a substantially straight, rigid, generally cylindrical body of a length … more preferably not greater than about 4 mm and not shorter than about 2 mm). Burns also calls for establishing communication between the anterior chamber and various drain pathways (¶ [0083], In other embodiments, the shunt is advanced through the ciliary body or ciliary muscle bundles to achieve fluid communication between the anterior chamber and the suprachoroidal space; ¶ [0093] The shunts may be of varied lengths to optimize flows. In some preferred embodiments, the shunt has sufficient length such that the outflow portion resides in the suprachoroidal space and the inflow portion is exposed to the anterior chamber).
A skilled artisan would have been able to modify Burns by adjusting the proximal extension length so that fluid can exit the anterior chamber with low resistance, and without obstructing the patient’s vision.
Too short
The implant will present a small cross-section to the anterior chamber and will have excessive fluid resistance
Optimized range
The implant will exhibit low flow resistance without obstructing the patient’s vision
Too high
The implant will extend too far into the anterior chamber, and interfere with the patient’s vision
Therefore, it would have been obvious to adjust the proximal extension length in order to balance the needs of low flow resistance and preserving a clear visual path between the cornea and iris. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Burns and De Juan in view of Burns ‘870, Thomas W. et al. (US 20040147870 A1).
Regarding claim 31, Burns and De Juan 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 Burns and De Juan 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 Burns and De Juan with Burns ‘870’s sterile packaging in order to supply surgical equipment in a single convenient location.
Claims 29, 33 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Burns and De Juan in view of Weber, David A. et al. (US 20050203542 A1).
Regarding claims 29, 33 and 38, Burns and De Juan 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 Burns and De Juan 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 Burns and De Juan with Weber’s trigger safety device in order to avoid accidentally deploying the implant. Therefore, it would have been obvious to modify Burns and De Juan with Weber’s reuse prevention structure in order to minimize the risk of contaminating another patient or inadvertently deploying the implant.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Burns and De Juan in view of McKenna; Robert H. et al. (US 20060253039 A1).
Regarding claim 41, Burns and De Juan 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 Burns and De Juan 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 Burns and De Juan with McKenna’s trigger safety member in order to avoid inadvertent actuation.
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 on an elongate body of the implant and configured to enable determination of proper depth of implant placement during deployment 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 26 June 2026 regarding the rejection of claims 21-29 and 31-41 as amended, under 35 USC § 103 over Horvath and Horvath ‘175 in view of Burns with incorporation of Tu, have been fully considered and are persuasive. After further consideration, the amended claims 21-29 and 31-43 are rejected on new grounds under 35 USC § 103 over Burns, De Juan, Burns ‘870, Weber and McKenna (see above).
Applicant’s arguments regarding Horvath, Horvath ‘175 and Tu have been considered but are moot because the references are no longer cited in the current rejection.
Applicant submits that Horvath teaches implantation of a shunt without the use of an optical apparatus, and therefore teaches away from inclusion of a visual aid on an implant (remarks p. 6). Examiner responds that Burns and De Juan are cited in the new grounds of rejection as teaching all features of amended claims 21 and 34. Burns does not teach away from using an optical apparatus and instead calls for using imaging equipment while deploying the implant (¶ [0119], The placement and implantation of the shunt can be performed using a gonioscope or other conventional imaging equipment).
Applicant asserts that Horvath's alleged pusher component 118 remains entirely within the alleged sleeve 130 during implantation (remarks p. 8). Examiner replies that Burns and De Juan are cited in the new grounds of rejection as teaching or suggesting all features of new claim 42.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Tel 571-272-2590
Fax 571-273-2590
Email Adam.Marcetich@uspto.gov
The Examiner can be reached 8am-4pm Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov.
Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights