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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Parent Application 2203542, filed in France on 15 April 2022 has been received.
Election/Restriction
Applicant’s election of Species A, claims 2-11, 14 and 23-26 in the reply filed on 28 August 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 18-20, 28 and 30-33 are withdrawn from further consideration and claims 1-17, 21-27, 29 and 34-36 are examined on their merits.
Claim Objections
The claims contain minor informalities.
In claim 14, the language “… each of said contact edge [[ports]] portions extending along …” should be changed for clarity.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17, 21-27, 29 and 34-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 1 calls for “… the body of the implant comprising a first or anterior edge intended to be oriented in the direction of the anterior chamber of an eye in contact with the root of the ciliary muscle …
… at least one protuberance oriented toward the exterior of the body to enable at least one local contact of said at least one protuberance on the root of the ciliary muscle.”
This language should be revised to remove the ciliary muscle and other parts of the eye from the claim scope. Examiner suggests to revise these features in terms of an anterior edge “configured to contact the root of the ciliary muscle” and a “protuberance configured for local contact with the root of the ciliary muscle.”
Claim 2 calls for “… said protuberances conjointly forming a discontinuous or local contact edge on the root of the ciliary muscle” which should be revised similarly.
Claim 7 calls for “… to enable the contact edge to come into contact with the root of the ciliary muscle …” which should be revised similarly.
Applicant is recommended to use inferential language (e.g. configured to, adapted to or whereby) to avoid positively claiming the human body.
The remaining dependent claims are rejected for depending on a rejected parent claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 17 calls for “…by the action of a force tending to press the anterior edge against a bearing surface …” This language does not completely characterize how the local thinning responds to an external force. Examiner suggests to rephrase this feature in terms of how the body responds to “an external force” or “an applied force.”
Claim 17 calls for “…by the action of a force tending to press the anterior edge against a bearing surface, for example the root of the ciliary muscle.” This language is ambiguous because the term “for example” does not clearly specify whether the ciliary muscle is the only option, or whether other anatomical structures are included in the claim scope.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 12, 23, 29 and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dahan, Elie (US 20040092856 A1).
Regarding claim 1, Dahan discloses an interpositional ophthalmological implant for permanent disposition between the sclera and uveal tissue (¶ [0001], a glaucoma drain; ¶ [0028] Such an implant enables in situ drainage for an extended period of several years, or even indefinitely; ¶ [0026] The glaucoma drain 1, as illustrated in FIG. 1, is adapted to be implanted in the deep scleral bed (LS) in the course of a deep non-penetrating sclerectomy (see FIGS. 2 and 3));
comprising: a uveo-compatible body, the body having three dimensions in space, namely a length and a width that are perpendicular to one another and a thickness (¶ [0026] The glaucoma drain 1, as illustrated in FIG. 1);
the body of the implant comprising a first or anterior edge intended to be oriented in the direction of the anterior chamber of an eye in contact with the root of the ciliary muscle (¶ [0057] The outline of the drain is defined by the edges of the transverse bar 50 and of the longitudinal body 60 and comprises a front edge 54 comprising a central convex portion of the transverse bar 50; ¶ [0045] The outline of the drain is defined by edges of the transverse bar 100 and of the longitudinal body 120 and comprises a convex front edge 114 of the transverse bar 110); and
a second or posterior edge opposite the anterior edge relative to the body (¶ [0045], rear end of the longitudinal body 123);
the anterior edge having, as seen in a view in projection in the plane containing the width and the length, at least one protuberance oriented toward the exterior of the body to enable at least one local contact of said at least one protuberance on the root of the ciliary muscle (¶ [0045] The outline of the drain is defined by edges of the transverse bar 100 and of the longitudinal body 120 and comprises a convex front edge 114 of the transverse bar 110; ¶ [0050], at least the convex front edge 114 of the transverse bar is in contact with the trabeculo-descemetic membrane (see FIG. 5) and the convex front edge 114 tensions it; ¶ [0057] The outline of the drain is defined by the edges of the transverse bar 50 and of the longitudinal body 60 and comprises a front edge 54 comprising a central convex portion of the transverse bar 50).
Regarding the protuberance being configured to contact the root of the ciliary muscle, Dahan discloses that the front edge 54 / 114 contacts and tensions the trabeculo-descemetic membrane (¶ [0050]). Applicant’s drawings show that the root of the ciliary muscle is located near Schlemm’s canal and the trabecula (Fig. 17). Therefore, Dahan’s implant also applies force to the root of the ciliary muscle.
Dahan’s implant is also capable of being implanted in a position that directly contacts the root of the ciliary muscle. Although Dahan does not explicitly describe the implant’s position in terms of the ciliary muscle, Dahan’s implant has a shape identical to the claimed implant. Dahan discloses that during surgery, the implant is delivered under a scleral flap and advanced towards Schlemm’s canal (¶ [0037], The configuration and the size of the drain enable implantation to be made entirely under the scleral flap and completely inside the intrascleral space; ¶ [0041], the drain may be entirely lodged inside the intra-scleral space after closing of the superficial scleral flap; ¶ [0050], As positioned with respect to Schlemm's canal, at least the convex front edge 114 of the transverse bar is in contact with the trabeculo-descemetic membrane (see FIG. 5)). A physician is able to deliver Dahan’s implant in any position beneath the sclera, including a position that contacts the root of the ciliary muscle. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011). See also MPEP 2114(I).
Regarding claims 12, 29 and 34, Dahan discloses an implant in which said at least one protuberance is configured to allow at least one localized contact on the root of the ciliary muscle (¶ [0050], As positioned with respect to Schlemm's canal, at least the convex front edge 114 of the transverse bar is in contact with the trabeculo-descemetic membrane (see FIG. 5) and the convex front edge 114 tensions it, such that its mesh, through stretching, increases the flow of aqueous humor through the trabeculo-descemetic membrane);
in which the body of the implant comprises at least one material that is chosen from the following materials: PTFE, polysiloxane, hydrophilic or hydrophobic acrylate hydrogels (¶ [0012] Preferably the non-resorbable hydrophilic material that is also non-pyrogenic, and, of course, biocompatible, is 38% polyhydroxyethyl methacrylate (38% PolyHEMA) or a hydrophilic acrylic);
in which the thickness of the body of the implant is between 50 and 1000 μm (¶ [0041] The drain is preferably thin with a thickness of the order of 0.1 mm except for the thickness of the projection which is of the order of 0.30 mm; ¶ [0055] The drain is preferably thin with a thickness of the order of 0.15 mm except for the thickness of the projection which is of the order of 0.30 mm).
Regarding claim 23, Dahan discloses that the body of the implant is elastically deformable (¶ [0012] Preferably the non-resorbable hydrophilic material that is also non-pyrogenic, and, of course, biocompatible, is 38% polyhydroxyethyl methacrylate (38% PolyHEMA) or a hydrophilic acrylic; ¶ [0055] The drain is preferably thin with a thickness of the order of 0.15 mm except for the thickness of the projection which is of the order of 0.30 mm, and is sufficiently flexible to follow the curvature of the scleral bed (LS)).
Dahan does not explicitly disclose that the implant can be folded without permanent deformation in order to be manipulated by a micro-instrument or injected using an ophthalmological injection system. However, Dahan constructs the implant from polyhydroxyethyl methacrylate, a material identical to Applicant’s materials (¶ [0046] In one embodiment of the implant the body of the implant comprises … PTFE, polysiloxane, hydrophilic or hydrophobic acrylate hydrogels; ¶ [0172] In this case the body of the implant may comprise … polypropylene, polymethylmethacrylate, titanium, stainless steel, Nitinol).
The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In this case, Dahan constructs an implant from materials identical to Applicant’s materials, namely a hydrophilic acrylate hydrogel. Therefore, the ability to fold without permanent deformation is presumed inherent. See MPEP 2112(I) and In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977).
Claim Rejections - 35 USC § 103
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 1-17, 21-27, 29 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Sourdille; Philippe (US 20180353329 A1) in view of Badawi; David Y. et al. (US 20110196487 A1).
Regarding claim 1, Sourdille discloses an interpositional ophthalmological implant for permanent disposition between the sclera and uveal tissue (¶ [0001], [0011], a permanent interpositional ophthalmological implant; ¶ [0019] The body of the implant is intended to separate the sclera and the uveal tissue);
comprising: a uveo-compatible body, the body having three dimensions in space, namely a length and a width that are perpendicular to one another and a thickness (¶ [0071] These three possible forms of implant, referenced 20, 30 and 40);
the body of the implant comprising a first or anterior edge intended to be oriented in the direction of the anterior chamber of an eye in contact with the root of the ciliary muscle (¶ [0071], a concave anterior edge 22, 32, 42); and
a second or posterior edge opposite the anterior edge relative to the body (¶ [0072] These three implants each have an opposite posterior edge 24, 34, 44).
Sourdille teaches the invention substantially as claimed by Applicant except for a protuberance. Badawi discloses devices, kits and methods for reducing intraocular pressure (¶ [0002], [0010], [0040], [0068], [0073]);
comprising: a uveo-compatible body (¶ [0083] FIG. 5B illustrates an example of a device 70 inserted into Schlemm's canal 30 through incision site 74; ¶ [0123], For example, FIG. 20A shows a support 2000 comprising multiple rings);
the body of the implant comprising a first or anterior edge intended to be oriented towards the anterior chamber; the anterior edge having at least one protuberance oriented toward the exterior of the body to enable at least one local contact of said at least one protuberance on the root of the ciliary muscle (¶ [0089], In FIGS. 8G-H, fluted edges 110' extend along sides 112' to form structures 116'. Structures 116' have serrated outer surfaces 115' extending between ends 114'; ¶ [0123], For example, FIG. 20A shows a support 2000 comprising multiple rings, such as ring 2002 … some variations of supports may comprise multiple rings having different sizes. Moreover, rings may have different shapes. For example, some rings may be rounded and circular, while other rings are oval and have somewhat beveled edges; ¶ [0126], As shown in FIG. 22B, elongated member 2212 has a curvy edge 2214; ¶ [0127], For example, FIG. 22D shows a support 2230 … Integral elongated member 2232 has a curvy edge 2233, while central tubular member 2236 comprises multiple apertures 2238).
Badawi adds drainage pathways for fluid to bypass the solid surfaces of a drainage implant (¶ [0126], Such an edge may, for example, have relatively little contact with the interior surface of Schlemm's canal, while still having sufficient contact to help restore or maintain at least partial patency of at least a portion of the canal). One would be motivated to modify Sourdille with Badawi’s protuberances to encourage flow along the implant body as suggested by Sourdille (¶ [0117], This flow may be encouraged along the body (from its anterior edge to its opposite posterior edge) and/or through the body). A skilled artisan would have been able to modify Sourdille with Badawi’s protuberances by adding a fluted or serrated shape along the anterior edge according to Badawi’s example. Therefore, it would have been obvious to modify Sourdille with Badawi’s protuberance in order to more effectively drain fluid from the anterior chamber.
Regarding claims 2 and 12-14, Sourdille discloses an implant capable of contacting the root of the ciliary muscle as discussed for claim 1. Sourdille does not explicitly disclose a plurality of protuberances. Badawi discloses an implant in which the anterior edge comprises a plurality of protuberances oriented toward the exterior of the body, said protuberances conjointly forming a discontinuous or local contact edge on the root of the ciliary muscle (¶ [0089], In FIGS. 8G-H … Structures 116' have serrated outer surfaces 115' extending between ends 114'; ¶ [0123], For example, FIG. 20A shows a support 2000 comprising multiple rings, such as ring 2002, all lying along the same plane; ¶ [0126], For example, FIG. 22B shows a support 2210 … As shown in FIG. 22B, elongated member 2212 has a curvy edge 2214; ¶ [0127] For example, FIG. 22D shows a support 2230 … Integral elongated member 2232 has a curvy edge 2233);
in which said at least one protuberance is configured to enable at least one linear contact on the root of the ciliary muscle (¶ [0085], FIGS. 6A and 6B illustrate side and front views, respectively, of exemplary elements or beads that may be used in the supports described here. As shown, solid 90 or hollow 91, spherical 90, spheroid 92, ovoid 93, conical 94, disk-shaped 95, polyhedral 96, rod-like 97, or beads with fluted edges 98, rough edges, 89, or spiked edges 88 may be used; ¶ [0110], As an example, FIG. 15A shows a support 1500 comprising integral chain "link" components, such as component 1502);
in which said at least one protuberance is configured to allow at least one localized contact on the root of the ciliary muscle (¶ [0089], In FIGS. 8G-H … Structures 116' have serrated outer surfaces 115'; ¶ [0123], FIG. 20A shows a support 2000 comprising multiple rings, such as ring 2002; ¶ [0126], As shown in FIG. 22B, elongated member 2212 has a curvy edge 2214; ¶ [0127] For example, FIG. 22D … Integral elongated member 2232 has a curvy edge 2233).
Regarding claim 14 and the contact profile extending along a concave trajectory, wherein each protuberance comprises a contact edge portion, each of said contact edge ports extending along the concave trajectory, this rejection combines Sourdille with Badawi’s protuberances. A skilled artisan would have been able to modify Sourdille with Badawi’s protuberances by adding serrations or hollow ring shapes along Sourdille’s concave anterior edge. Regarding the rationale and motivation to modify Sourdille with Badawi’s protuberances, see the discussion of claim 1 above.
Regarding claim 3-11, 15-17, 23-27, 29 and 34-35, Sourdille discloses an implant in which the contact edge defines a contact profile of the anterior edge on the root of the ciliary muscle, said contact profile extending along a concave trajectory; in which the contact profile of the contact edge extends along at least one circular trajectory; in which the contact profile of the contact edge comprises at least one profile portion extending along a circular trajectory (¶ [0025] the concave curvature of the anterior edge has a radius of curvature between 5 and 7 mm; such a radius of curvature of the anterior edge allows this edge to be positioned concentrically with the corneal margin; ¶ [0030] the second concave curvature has a radius of curvature of between 10 and 15 mm; ¶ [0062] The radius of curvature of the concave edge is, for example, comprised between 5 and 7 mm; ¶ [0071] These three possible forms of implant, referenced 20, 30 and 40, each have in common a concave anterior edge 22, 32, 42).
in which the contact profile of the contact edge comprises at least two profile portions extending along circular trajectories having different radii of curvature (¶ [0025] the concave curvature of the anterior edge has a radius of curvature between 5 and 7 mm; ¶ [0030] the second concave curvature has a radius of curvature of between 10 and 15 mm);
in which the contact profile of the contact edge comprises at least one first profile portion extending along a first circular trajectory having a first radius of curvature (¶ [0025] the concave curvature of the anterior edge has a radius of curvature between 5 and 7 mm); and
at least one second profile portion extending along a second circular trajectory having a second radius of curvature greater than the first radius of curvature to enable the contact edge to come into contact with the root of the ciliary muscle having a plurality of possible anatomical radii (¶ [0030] the second concave curvature has a radius of curvature of between 10 and 15 mm; this radius of curvature is particularly well suited to allowing the body of the implant to mold to the spherical portion of the underlying ciliary body);
in which the first profile portion is formed at the level of a central zone of the contact edge, the second profile portion being disposed at the level of a peripheral zone of the contact edge; in which the second profile portion is disposed on either side of the first profile portion along the contact edge (¶ [0075] The body of the implant 30 here has, in projection in a plane perpendicular to the thickness, an external peripheral contour with a convex geometry with the exception of the portion 32a of the body which comprises the concave anterior edge 32. The remaining portion 32b of the body in projection in this plane has a convex geometry);
in which at least one radius of curvature of the circular trajectory is greater than or equal to 4.5 mm and less than or equal to 6 mm (¶ [0025] the concave curvature of the anterior edge has a radius of curvature between 5 and 7 mm);
in which at least one radius of curvature of the circular trajectory is greater than 6 mm and less than or equal to 7.5 mm (¶ [0025] the concave curvature of the anterior edge has a radius of curvature between 5 and 7 mm);
in which the thickness of the anterior edge is thinned relative to the thickness of the body; in which the anterior edge comprises an upper portion and a lower portion, the thickness of the anterior edge being thinned at the level of the upper portion (¶ [0022] the body is for example thinned at the anterior edge, with respect to the remainder of the body; ¶ [0094] The convex upper face 50a is intended to face the sclera, whereas the concave lower face is intended to face the uveal tissue; ¶ [0110] In the example of FIG. 2a (although this would also apply to FIGS. 2b and 2c) the concave anterior edge 52 has been depicted as thinned over a distance or dimension “I” which is comprised between 100 and 400 μm);
in which the body comprises a local thinning of thickness situated set back from the anterior edge and configured to enable elastic deformation of the anterior edge by the action of a force tending to press the anterior edge against a bearing surface, for example the root of the ciliary muscle (¶ [0089] The body of this implant is made from an elastically deformable material; ¶ [0110] In the example of FIG. 2a (although this would also apply to FIGS. 2b and 2c) the concave anterior edge 52 has been depicted as thinned over a distance or dimension “I” which is comprised between 100 and 400 μm);
in which the body of the implant is elastically deformable in such a manner as to be able to be folded without permanent deformation in order to be manipulated by a micro-instrument or injected using an ophthalmological injection system (¶ [0026] the body of the implant is elastically deformable so that it can be bent without inducing permanent deformation so that it can be handled using a micro instrument, or injected using an ophthalmological injection system; ¶ [0028] the body of the implant is made from a material which has a Young's modulus of between 30 and 60 kg/cm.sup.2; this rigidity/flexibility characteristic allows the body to deform elastically as it is being inserted into the eye);
wherein at least one radius of curvature of the circular trajectory is greater than or equal to 4.5 mm and less than or equal to 6 mm, and in which the body of the implant is configured to have at least one radius of curvature of the circular trajectory that is greater than or equal to 4.5 mm and less than or equal to 6 mm when the implant is disposed in a deformed state corresponding to a disposition of the body of the implant between the sclera and uveal tissue (¶ [0025] the concave curvature of the anterior edge has a radius of curvature between 5 and 7 mm; such a radius of curvature of the anterior edge allows this edge to be positioned concentrically with the corneal margin; ¶ [0030] the second concave curvature has a radius of curvature of between 10 and 15 mm; ¶ [0062] The radius of curvature of the concave edge is, for example, comprised between 5 and 7 mm);
wherein at least one radius of curvature of the circular trajectory is greater than 6 mm and less than or equal to 7.5 mm, and in which the body of the implant is configured to have at least one radius of curvature of the circular trajectory that is greater than 6 mm and less than or equal to 7.5 mm when the implant is disposed in said deformed state corresponding to a disposition of the body of the implant between the sclera and the uveal tissue (¶ [0025] the concave curvature of the anterior edge has a radius of curvature between 5 and 7 mm; such a radius of curvature of the anterior edge allows this edge to be positioned concentrically with the corneal margin; ¶ [0030] the second concave curvature has a radius of curvature of between 10 and 15 mm; ¶ [0062] The radius of curvature of the concave edge is, for example, comprised between 5 and 7 mm);
in which the body of the implant has in a deformed state in which it can be used as an interpositional ophthalmological implant between the sclera and the uveal tissue a concave curvature in a direction perpendicular to a plane defined by the two dimensions of the implant that are perpendicular to the thickness (¶ [0096] The body of the implant is made from a material that has a Young's modulus comprised between 30 and 60 kg/cm.sup.2. Such a modulus gives the body a flexibility characteristic that allows it to deform elastically when inserted into the eye and then be kept in a permanently deformed state by the overlying and underlying structures of the eye, conforming to the natural curvature of these structures);
in which the body of the implant is made of a material that has a Young's modulus between 30 and 60 kg/cm.sup.2 or between 30,000 and 2,500,000 kg/cm.sup.2 (¶ [0028] the body of the implant is made from a material which has a Young's modulus of between 30 and 60 kg/cm.sup.2).
in which the body of the implant comprises at least one material that is chosen from the following materials: PTFE, polysiloxane, hydrophilic or hydrophobic acrylate hydrogels (¶ [0039] the body of the implant comprises at least one material chosen from the following materials: PTFE, polysiloxane, hydrophilic or hydrophobic acrylate hydrogels);
in which the thickness of the body of the implant is between 50 and 1000 μm (¶ [0058], By way of example, for a body with dimensions (width and length) of 4×5 mm, its thickness is 0.3 mm);
in which the body of the implant has properties of releasing one or more substances (¶ [0133] The body of the implant has properties of releasing one or more substances. Such substances are, for example, anti-infection and/or anti-inflammatory substances. They may be antibiotic and/or cortisone or anti-cortisone substances).
Regarding the various claimed circular trajectories, Sourdille describes the concave curvature in terms of its radius (¶ [0025], [0030]). Quantifying the trajectories in terms of their radii implies that the trajectories are circular.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sourdille and Badawi in view of Lisk, James R. Jr. et al. (US 20040260227 A1).
Regarding claims 21 and 22, Sourdille and Badawi lack an aqueous humor collecting recess. Lisk discloses ophthalmic implants and surgical techniques for draining ocular aqueous fluid (¶ [0002], [0003], [0007], [0030], FIGS. 1 and 2 show an ophthalmic implant … implant 10; ¶ [0047] FIG. 9 … implant 300);
Comprising a body including a first or anterior edge intended to be oriented in the direction of the anterior chamber of an eye (¶ [0030], the feet 14 can be positioned in the anterior chamber; ¶ [0034] The implant feet 14 have a curvature 22 that is approximately the same as the curvature of the anterior chamber at the sclera of the patient); and
a second or posterior edge opposite the anterior edge relative to the body (¶ [0032] The implant body 12 has outer portions 18);
in which the body forms at least one aqueous humor collecting recess opening at the level of the anterior edge (¶ [0047] FIG. 9 … the implant 300 having drainage passageways provided by longitudinal drainage passageways 380 as well as lateral drainage passageways 382);
Lisk provides further drain passages to direct fluid along and past the implant’s surfaces (¶ [0047] The lateral drainage passageways 382 deliver the ocular fluid across the implant 300 to its sides for dispersing the fluid over a larger area into the sclera 52 for better absorption by the lymphatic vessels).
This rejection modifies Sourdille and Badawi with Lisk’s aqueous humor collecting recess by adding Lisk’s aqueous humor collecting recess to the implant’s surface. This combination provides an implant including an anterior edge comprising a plurality of protuberances and in which said at least one recess is formed between two protuberances. Badawi discloses a plurality of regularly spaced protuberances, and Lisk discloses a plurality of aqueous humor collecting recess. Combining these features arranges at least one of the recesses between protuberances.
One would be motivated to modify Sourdille and Badawi with Lisk’s aqueous humor collecting recess since Sourdille calls for augmenting flow along the implant body (¶ [0117], This flow may be encouraged along the body (from its anterior edge to its opposite posterior edge) and/or through the body). Therefore, it would have been obvious to modify Sourdille and Badawi with Lisk’s aqueous humor collecting recess in order to provide further fluid passages along the implant’s outer surface.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Sourdille and Badawi in view of Lynch; Mary G. et al. (US 20070293807 A1).
Regarding claim 36, Sourdille and Badawi do not explicitly disclose that the posterior edge is at a distance of less than 1.0 mm from the anterior edge. Lynch discloses a device and method for reducing intraocular pressure (¶ [0003], [0027], [0073], [0080] FIG. 1A … shunt device 100);
wherein a posterior edge is at a distance of less than 1.0 mm from an anterior edge (¶ [0080], The total length of the distal portion 25 may be between about 1.0 mm to 40 mm, preferably about 4 mm to 6 mm; ¶ [0089] FIG. 4 shows another embodiment of the shunt … The wicking extensions 32 … preferably have a length of about 1.0 mm to about 16.0 mm; ¶ [0096], The proximal portion 10 is preferably of sufficient length, about 0.1 to about 3.0 mm or about 2.0 mm, to extend from its junction with the distal portion 25 in Schlemm's canal).
Lynch demonstrates that ocular implants have a wider range of effective sizes. One would be motivated to modify Sourdille and Badawi with Lynch’s shorter posterior-anterior distance to accommodate differently sized eyes or eyes with different geometries. Therefore, it would have been obvious to modify Sourdille and Badawi with Lynch’s posterior-anterior distance in order to accommodate a wider range of physiologic geometries.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
