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 Objections
Claims 23-26 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claims 23-26 have not been further treated on the merits.
Response to Arguments
Applicant’s arguments, see page 7, filed 30JUN2026, with respect to the rejection(s) of claim(s) 1-5, 10-13, 17-19, and 23 under 35 U.S.C. § 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of Chew in view of Lind, with Lind teaching a plurality of placements for the drainage tube, the tube further comprising a plurality of drainage openings which are considered to be placed as claimed.
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.
The factual inquiries 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.
Claim(s) 1-5, 10-13, 17-19, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170020730 A1 (Chew et al.) in view of US 20160067092 A1 (Lind et al.).
Regarding Claim 1, Chew teaches an ocular implant (2) (Fig. 1A) for draining aqueous humor from an anterior chamber of the eye for the treatment of glaucoma [0001, 0058], the implant comprising a plate (the lower surface of 4) and a drainage tube (6) extending from the plate, the drainage tube having a distal end (16) forming an inlet [0067] locatable in the anterior chamber and a proximal end (14) forming an outlet (acting as an outlet into the plate, as seen in Fig. 1B), the outlet fluidly interfacing the plate (Fig. 1B).
Chew further teaches a side drainage outlet (38), but fails to teach the aqueous humour received from the anterior chamber through the inlet can drain from the outlet across the plate to provide primary outflow drainage within a subconjunctival space, wherein the drainage tube defines a side drainage outlet through a side wall of the drainage tube at a location spaced from the plate and between the inlet and the outlet, the side drainage outlet being positioned closer to the outlet than the inlet and being configured so that aqueous humour flowing along the drainage tube from the inlet toward the outlet exits the drainage tube through the side drainage outlet into the subconjunctival space to provide secondary outflow drainage within the subconjunctival space.
Lind teaches an ocular implant (300) (Fig. 3) comprising a drainage tube (400) (Fig. 8) ([0044] describing use of tube (400) with implant (300)), wherein the drainage tube defines a side drainage outlet (hole (480) located along the length of the tube, including a side drainage outlet located nearest the plate) adjacent the plate between the inlet and the outlet ([0046] describing the holes as extending the length of the tube and thereby being located adjacent the plate between the inlet and outlet) and wherein the side drainage outlet is positioned closer to the outlet than the inlet (the outlet being at the plate) so that aqueous humour received from the anterior chamber through the inlet can drain from the outlet across the plate to provide primary outflow drainage within a subconjunctival space, wherein the drainage tube defines a side drainage outlet through a side wall of the drainage tube at a location spaced from the plate and between the inlet and the outlet, the side drainage outlet being positioned closer to the outlet than the inlet and being configured so that aqueous humour flowing along the drainage tube from the inlet toward the outlet exits the drainage tube through the side drainage outlet into the subconjunctival space to provide secondary outflow drainage within the subconjunctival space (as the side drainage outlet is located at the outlet and the tube extends into the subconjunctival space as required, it is considered to be positioned to allow drainage as claimed, with [0026] teaching potential drainage location).
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 the drainage tube of Chew to incorporate the side drainage outlet as located by Lind to guard against blockages of flow, as desired by both Chew [0212] and Lind [0045].
“[S]o that aqueous humour received from the anterior chamber through the inlet can drain from the outlet across the plate to provide primary outflow drainage within a subconjunctival space, wherein the drainage tube defines a side drainage outlet through a side wall of the drainage tube at a location spaced from the plate and between the inlet and the outlet, the side drainage outlet being positioned closer to the outlet than the inlet and being configured so that aqueous humour flowing along the drainage tube from the inlet toward the outlet exits the drainage tube through the side drainage outlet into the subconjunctival space to provide secondary outflow drainage within the subconjunctival space” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claims 2-4, Chew in view of Lind teaches side drainage outlet (38) locations extending the length of the drainage tube (6), as previously cited. As any of these side drainage outlets positioned closer to the outlet than the inlet fulfill the requirements of Claim 1, the device of Claim 1 is considered to teach:
the side drainage outlet is located approximately a quarter of a length of the drainage tube away from the outlet;
the side drainage outlet is located less than 8 mm from the outlet (Chew teaching a drainage tube length up to 20 mm [0027], therefore a distance of less than 8 mm necessarily being positioned closer to the outlet than the inlet); and
the side drainage outlet is located approximately 5 mm from the outlet.
Regarding Claim 5, the device of Claim 1 is considered to teach the drainage tube (6) defines two side drainage outlets (38) which are offset along a length of the drainage tube as combined device possesses a plurality of side drainage outlets along the length of the drainage tube.
Regarding Claim 10, Chew further teaches the plate (4) defines a central portion (Chew Annotated Fig. 1A) substantially aligned with a longitudinal axis (the axis defined along (10) and the length of the drainage tube (6), as seen in Fig. 1A) of the proximal end of the drainage tube (14) and side wings (Chew Annotated Fig. 1A) either side of the central portion and wherein the plate is elastomeric (being described as both a medical grade elastomer [0112] and being flexible [0064].
“[S]o that the side wings can be folded over the central portion” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
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Chew Annotated Fig. 1A
Regarding Claim 11, Chew further teaches lines of weakness (10) between the central portion and the side wings (Chew Annotated Fig. 1A).
Regarding Claim 12, Chew further teaches the lines of weakness (10) are generally orientated parallel with a longitudinal axis (the axis defined along (10) and the length of the drainage tube (6), as seen in Fig. 1A) of the drainage tube (6).
Regarding Claim 13, Chew further teaches the lines of weakness (10) are formed by channels indented within a surface of the plate (4) (said lines being channels in the surface of the plate [0063]).
Regarding Claim 17, Chew further teaches the plate (4) defines a well (8) and wherein the well extends across the central portion and the side wings (Chew Annotated Fig. 1A).
Regarding Claim 18, Chew is considered to teach the well (8) is formed by a wall raised from an upper surface of the plate and wherein the wall and the plate are integrally formed as the well may be on and/or in the plate (4) [0059], the well necessarily having a wall to contain its contents.
Regarding Claim 19, Chew further teaches the plate (the lower surface of 4) defines a well (8) formed by a wall (necessarily having a wall to contain its contents) which holds material over the plate [0200], the wall being raised from an upper surface of the plate (Fig. 1A) and wherein the wall comprises a drainage perforation (32) between an inner side and an outer side thereof [0110].
Regarding Claim 22, Chew further teaches method of implanting the implant (2) as claimed in claim 1, the method comprising implanting the implant so that the plate (the bottom surface of (4)) and the side drainage outlet (38) locate within the subconjunctival space. wherein aqueous humour received from the anterior chamber through the inlet drains from the outlet across the plate to provide primary outflow drainage within the subconjunctival space, and wherein aqueous humour flowing along the drainage tube from the inlet toward the outlet exits the drainage tube through the side drainage outlet into the subconjunctival space to provide secondary outflow drainage within the subconjunctival space, the drainage outlet placed as detailed in Claim 1 and thereby being in the subconjunctival space ([0040] describing implant location).
“[W]herein aqueous humour received from the anterior chamber through the inlet drains from the outlet across the plate to provide primary outflow drainage within the subconjunctival space, and wherein aqueous humour flowing along the drainage tube from the inlet toward the outlet exits the drainage tube through the side drainage outlet into the subconjunctival space to provide secondary outflow drainage within the subconjunctival space” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chew in view of Lind, and further in view of US 20120053505 A1 (Yaron et al.).
Regarding Claim 6, Chew fails to teach a side channel for the side drainage outlet, wherein the channel protrudes out from a surface of the tube.
Yaron teaches an ocular implant (30) (Figs. 2, 3, 15, and 16) comprising a side channel (the formation around (253) which retains (252)) for the side drainage outlet (42), wherein the side channel protrudes out from a surface of the drainage tube (32) (Fig. 15).
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 the side channel of Chew with the side channel of Yaron to prevent clogging of the drainage [Yaron 0051].
Regarding Claim 7, Chew in view of Yaron fails to teach wherein the channel is tubular and wherein the side drainage outlet is formed therethrough as the drain outlet.
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 the shape of the channel of Chew in view of Yaron to be tubular as a simple change in shape. The change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Regarding Claims 8 and 9, the device of Claim 6 is considered to teach the side channel (the formation around (253) which retains (252)) is formed by a protrusion (252) adjacent the side drainage outlet (42), as seen in Fig. 15, wherein the protrusion is semicircular (as seen in Fig. 15).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chew in view of Lind, and further in view of US 20220387217 A1 (Argento et al.).
Regarding Claim 14, Chew further teaches that the plate may be polished to provide a smooth surface, which would necessarily indicate some form of texture in the absence of optional polishing, but fails to explicitly teach an undersurface of the plate is textured at the central portion and smooth at the side wings.
Argento teaches an ocular implant (Fig. 7A) an undersurface of the plate (720) is textured at the central portion [0071].
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 the plate of Chew with the texturing of Argento to reduce axial or lateral migration [Argento 0071].
By incorporating the texture of Argento, the combined device is considered to have a textured undersurface at the central portion and to be smooth at the side wings.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chew in view of Lind, and further in view of US 20100249691 A1 (Van Der Mooren et al.).
Regarding Claim 15, Chew further teaches the tube may be smooth such that it will have atraumatic edges [0068], but fails to explicitly teach at least a portion of an exterior surface of the drainage tube is textured.
Van Der Mooren teaches an ocular implant (10) (Fig. 1) wherein at least a portion of an exterior surface of the drainage tube is textured [Abstract, 0067].
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 the drainage tube of Chew with the texturing of Van Der Mooren to provide control over bleb size [Van Der Mooren Abstract].
Regarding Claim 16, Chew fails to teach an undersurface of the drainage tube is textured and an upper surface of the drainage tube is smooth.
Van Der Mooren teaches an ocular implant (10) (Fig. 1) wherein the drainage tube is textured [Abstract, 0067] and texturing can exist on an undersurface of the drainage tube is textured and an upper surface of the drainage tube is smooth [0106].
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 the texturing of the drainage tube of Chew with the selective texturing as taught by Van Der Mooren to control bleb formation [Van Der Mooren Abstract].
Claim(s) 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chew in view of Lind, and further in view of US 6881197 B1 (Nigam).
Regarding Claims 20 and 21, Chew further teaches suture holes (34) which secure the plate over the sclera in the subconjunctival pocket (Claim 26). While the sutures are in the vicinity of the side drainage outlet of Claim 1, Chew in view of Lind fails to teach the formation of suture loops around the drainage tube.
Nigam teaches an ocular implant (10) (Fig. 1) wherein sutures are placed to form suture loops around the drainage tube (12) in the vicinity of the area corresponding to the side drainage outlet of Claim 1. Nigam further teaches placement of sutures at both (36) and (40) (Col. 14: ll. 5-7, Col. 7: ll. 9-13).
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 the device of Chew in view of Lind to incorporate the suture locations of Nigam to facilitate suturing of the tube in the desired position within the body (Nigam Col. 7: ll. 9-13).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chew in view of Lind, and further in view of US 20090177138 A1 (Brown et al.).
Regarding Claim 27, Chew in view of Lind fails to teach a method comprising folding the side wings of the central portion to make the plate into a compact configuration, inserting the plate when in the compact configuration through a conjunctival opening wherein the side wings are unfolded within the subconjunctival space and wherein the plate is not secured to the sclera with stitches.
Brown method comprising folding the side wings of the central portion to make the plate into a compact configuration, inserting the plate when in the compact configuration through a conjunctival opening wherein the side wings are unfolded within the subconjunctival space and wherein the plate is not secured to the sclera with stitches.
Brown teaches a method of implanting an implant (910) comprising folding the side wings (at 930) of the central portion to make the plate into a compact configuration (as seen in Figs. 9A-9C and described in [0059]), inserting the plate when in the compact configuration through a conjunctival opening wherein the side wings are unfolded within the subconjunctival space [0060, 0013] and wherein the plate is not secured to the sclera with stitches ([0053] describing the sutures which secure the device to the sclera not being placed through the plate).
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 the method of Chew in view of Lind with the folded insertion method of Brown to allow for a smaller insertion incision [Brown 0045].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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.
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/HANS KALIHER/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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