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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/23/2026 has been entered.
An amendment was filed on 06/23/2026. Claims 1 and 35 have been amended. Currently, claims 1-4, 7-10, 12-23, 27-35, 37-38, and 40-41 are pending with claims 28-34 being previously withdrawn. Claims 1-4, 7-10, 12-23, 27, 35, 37-38, and 40-41 are being examined on the merits
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 35 have been considered but are not persuasive and/or are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Notably, Suson (US 5626558) is utilized to teach openings wherein a lumen/reservoir is initially sealed, and given openings prior to implantation.
In response to applicant’s arguments that Siewert does not have the claimed open aperture area because they are obstructed by membrane 20, and that removing the membrane 20 of Siewert would change the device’s principles of operation, the examiner respectfully notes that Simon already teaches the apertures having an open aperture area, and Siewert merely teaches the openings effectively being on the side surface to prevent hypotension. While Siewert utilizes the membrane, Simon does not appear to need the membrane of Siewert, and Siewert states that the openings perform their function even after the membrane degrades (paragraph 0049, As a result, even after the complete degradation of the membrane 20, flow resistance required for the prevention of hypotension can be maintained”)
In response to the applicant’s arguments with respect to the remaining claims, noted for either similar arguments to claim 1 or arguments for allowance based on dependency on claim 1, the arguments with respect to claim 1 have been addressed above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 8, 10, 12-16, 19, 21, 23, 37-38, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Simon (US 20040254521) in view of Siewert (US 20160367403), and further in view of Yaron (US 20100274259), Horvath (US 20140236067), and Suson (US 5626558).
Regarding claim 1, Simon discloses a drainage device for use in an eye to drain aqueous humor so as to reduce intraocular pressure (abstract), the device comprising
a flexible multi-lumen tube (fig. 3, implant with channels from inflow port 112A to outflow port 112B) having an upper surface (fig. 3B shows the device with an upper surface) a first end (Fig. 3, first end near inflow port 112A), a second end opposite the first end (Fig. 3, outflow port 112B denotes second opposite end), a longitudinal axis through the first end and the second end (fig. 3, longitudinal axis from the ports 112A and 112B), a plurality of lumen extending between the first end and the second end and including at least a first lumen and a second lumen (fig. 3 shows multiple lumens through port 112A to port 112B), and an outer surface extending between the first end and the second end (fig. 3, outer surface made outside the lumen), wherein a cross-section perpendicular to the longitudinal axis has a non-circular shape at the outer surface (fig. 3, cross section is an elongated slot with curved ends), wherein apertures with open aperture areas are formed for the second lumen (paragraph 0057 discloses inflow ports 112A, fig. 3 shows opening at 112A as an open aperture), and wherein a fluid path is defined upon implantation from outside the multi-lumen tube, through the open aperture area of the at least one aperture and the second lumen, and to an open end of the second lumen at the second end (fig. 3 shows a flow path leading from outside 112A, into 112A through the lumen and out of 112B)
Simon appears to teach wherein the cross-section perpendicular to the longitudinal axis has an aspect ratio of at least 3:1.
However, if this is not clearly envisioned by the applicant, there is no evidence of record that establishes that changing the aspect ratio would result in a difference in function of the Simon device. Further, a person having ordinary skill in the art, being faced with modifying the cross-section of Simon, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the ratio may be 3:1 and offers other acceptable ranges (paragraph 0020, “at least 3:1, or at least 4:1, or at least 5:1… at least 6:1, or at least 7:1, or at least 8:1“).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that the cross-section perpendicular to the longitudinal axis has an aspect ratio of at least 3:1 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Simon discloses openings that control the flow rate of aqueous humor through the drainage device (paragraph 0057 discloses inflow ports 112A, which “control” flow rate via their geometry),
but fails to teach the tube having a sealed first end with a beveled end surface, wherein the first lumen is sealed at the first end by the beveled end surface, wherein the second lumen is initially sealed and comprises at least one aperture subsequently formed therein prior to implantation through the beveled end surface or the outer surface, , wherein the at least one aperture is located along a length of the multi-lumen tube between the first end and the second end at a selected distance from the second end, wherein the selected distance is pre-determined based on a calculated target reduction in intraocular pressure to achieve a desired therapeutic flow rate of aqueous humor through the drainage device
However, Siewert teaches a glaucoma drainage implant (abstract) that comprises a lumen that is sealed at its first end surface (fig. 8, lumen with closed end near section D) and comprises an aperture open in said lumen through a sidewall of the tube located along a length of the tube between the first end and the second end (fig. 9 shows at least one aperture 141 in the sidewalls), wherein the aperture fluidly connects to the second end of the tube outside of the tube through said lumen to control the flow rate of aqueous humor through the drainage device (fig. 9, opening 141 connects to the other end C shown in fig. 8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that at least one of the lumen is sealed at the first end wherein the first lumen is sealed at the first end by the end surface, wherein the second lumen comprises at least one aperture formed therein through the beveled end surface or the outer surface, and wherein a fluid path is defined from outside the multi-lumen tube, through the at least one aperture and the second lumen, and to an open end of the second lumen at the second end, as suggested by Siewert, for the purpose of providing a suitable location that can restrict flow to prevent hypotension (see Siewert, paragraph 0049, “In order to limit the flow of the aqueous humor, holes 141 that are covered by the overlying membrane 20 are arranged as radial inflow openings that are distributed around the periphery of the base body 14. As a result, even after the complete degradation of the membrane 20, flow resistance required for the prevention of hypotension can be maintained.”, thus suggesting that the positioning of the openings also contributes to flow resistance).
Simon, as modified by Siewert, does not teach the tube having a sealed first end with a bevel end surface, wherein the first lumen is sealed at the first end by the beveled end surface.
However, Yaron teaches wherein the first end is beveled, and/or is beveled at both ends (paragraph 0015).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon in view of Siewert such that the multi-lumen tube has a beveled end surface, as taught by Yaron, for the purpose of providing a suitable structure that aids in implantation through tissue and prevent clogging when faced away from the iris (see Yaron, paragraph 0129).
Simon, as modified by Siewert, is silent to wherein said at least one aperture is at a selected distance from the second end, wherein the selected distance is pre-determined based on a calculated target reduction in intraocular pressure to achieve a desired therapeutic flow rate of aqueous humor through the drainage device.
However, Horvath teaches wherein the flow rate of a shunt can be altered by cutting the shunt to increase the flow through the shunt (paragraph 0129). Such as cut would change the distance between the aperture from the second end, and this decision appears to be done for a desired therapeutic flow rate. Paragraph 0128 describes that if intraocular pressure is at an undesirable level, the clinician can modify the shunt accordingly. Lastly, paragraph 0178 describes that laminar flow/flow rate through the tube can be calculated using the Hagen-Poiseuille equation as part of the design considerations of the shunt, notably when it comes to the length of the channel. Thus. Horvath teaches wherein the distance of the opening from the second end is based on calculated flow rate and desired reduction in intraocular pressure.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon in view of Siewert such that said at least one aperture is at a selected distance from the second end, wherein the selected distance is pre-determined based on a calculated target reduction in intraocular pressure to achieve a desired therapeutic flow rate of aqueous humor through the drainage device, as taught by Horvath, for the purpose of providing a suitable means of granting control of the flow rate of the shunt (see Horvath, paragraph 0178).
Simon, as modified by Siewert, is silent to wherein the second lumen is initially sealed and the aperture is subsequently formed therein prior to implantation.
However, Suson teaches an ocular implant (abstract) that teaches wherein an initially sealed reservoir can have openings or perforations creates with a laser after implantation, and suggests openings or perforations may be placed in the reservoir prior to implantation (col. 3, lines 65-67 and col. 4, lines 1-11, “The flow rate of aqueous humor through the device may be initiated and thereafter periodically adjusted in a linear manner at any time after implantation in order to increase the flow rate of aqueous humor and thereby lower intraocular pressure, by placing one or more openings or perforations in the reservoir. If the reservoir is located outside of the eye, the openings or perforations may be created by non-mechanical means such as a laser. Additionally, one or more openings or perforations may be placed in the reservoir prior to implantation, allowing a small rate of flow of aqueous humor from the device, but at a low level which is insufficient to relieve all of the intraocular pressure due to glaucoma.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon in view of Siewert such that the second lumen is initially sealed and the aperture is subsequently formed therein prior to implantation, as suggested by Suson, for the purpose of providing a means of initiating and thereafter adjusting flow rate through the implant (see Suson, col. 3, lines 65-67 and col. 4, lines 1-11)
Regarding claim 8, Simon, as modified by Siewert and Bigler, discloses wherein the at least one aperture is a first aperture, further comprising at least a second aperture formed in the first lumen (see annotated fig. 3 below)
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Regarding claim 10, Simon discloses wherein the first lumen has an internal diameter selected to provide predetermined resistance to fluid flow through the device (fig. 15B, lumen has internal diameter that inherently provides a resistance).
Regarding claim 12, Simon fails to teach wherein each lumen has a diameter of between approximately 40-200 microns.
However, another embodiment of Simon teaches wherein the width of the lumen has a diameter of 50 microns (paragraph 0084, “In one embodiment the open and closed microchannels 310, 315 are about 50 microns wide with 50 micron spacing.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Fig. 3 of Simon such that each lumen has a diameter of between approximately 40-200 microns, for the purpose of providing a suitable diameter for the lumens that can serve the function of reducing intraocular hypertension (abstract).
Regarding claim 13, Simon discloses wherein each lumen has a substantially constant cross section along a length of the multi-lumen tube (Fig, 3, microchannels 110 has consistent cross-sections).
Regarding claim 14, Simon fails to teach wherein a length of the multi-lumen tube is between approximately 5 mm to approximately 30 mm.
However, Simon teaches wherein the length of the body 102 ranges between 2.0 mm and 10.0 mm (paragraph 0065).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that a length of the multi-lumen tube is between 5-30 mm since the applicant appears to have placed no criticality on the claimed range, providing multiple acceptable ranges (paragraph 0028, “The tube length may be between approximately 5 mm to approximately 30 mm, preferably between approximately 5 mm to approximately 20 mm, more preferably between approximately 8 mm to approximately 15 mm”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 15, Simon is silent to wherein a width of the multi-lumen tube is between 0.5 mm to approximately 3 mm.
However, Simon teaches wherein the width is from 0.5 mm and 5.0 mm (paragraph 0065).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that the width of the multi-lumen tube is between 0.5 mm to approximately 3 mm since the applicant appears to have placed no criticality on the claimed range, providing multiple acceptable ranges (paragraph 0029, “The tube width may be between approximately 0.5 mm to approximately 3 mm, preferably between approximately 1 mm to approximately 2 mm”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 16, Simon discloses wherein a maximum height of the multi-lumen tube is approximately 500 microns or less (paragraph 0065, “The thickness of the shunt body ranges, in various embodiments and shapes, from about 2 microns to 50 microns”).
Regarding claim 18, Simon is silent to wherein at least one of the plurality of lumens has a substantially circular cross section.
However, Suson teaches that lumens with substantially circular cross-sections are well known in the art (fig. 6, bore 124 is circular where aqueous humor passes, col. 5, lines 30-40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that at least one of the plurality of lumens has a substantially circular cross section, as taught by Suson, since it has been held that the shape of the lumen is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed lumen was significant, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and MPEP 2144.04(IV).
Regarding claim 19, Simon discloses wherein the multi-lumen tube includes biocompatible and/or biostable material (claim 16, wherein said system is comprised of at least one biocompatible material”.
Regarding claim 21, Simon is silent to wherein a sidewall of the multi-lumen tube has a thickness of between approximately 5 microns to approximately 200 microns.
However, Simon suggests a width of the device being between 500 microns and 5000 microns (paragraph 0065), wherein the microchannels in one embodiment are 50 microns wide with 50 micron spacing (paragraph 0084). Thus, a sidewall having a thickness of 5-200 microns is feasible within the context of Simon
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that the sidewall has a thickness of between 5-200 microns, for the purpose of providing a suitable thickness that simultaneously gives proper structure to the multi-lumen tube while allowing it to be deformable to confirm to scleral curvature (paragraph 0060), and since there is no evidence of record that establishes that changing the thickness of the sidewall would result in a difference in function of the Simon device. Further, a person having ordinary skill in the art, being faced with modifying the sidewall of Simon, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thicknesses. Lastly, applicant has not disclosed that the claimed range solves any states problem, providing other ranges (paragraph 0035), and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Regarding claim 22, Simon is silent to wherein the multi-lumen tube includes transparent or translucent material.
However, Suson teaches wherein the tubing may be translucent (col. 6, lines 59-67), with the material being physiologically inert and preferably silicone.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that the multi-lumen tube includes translucent material, as taught by Suson, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of design choice. In re Leshin, 125 USPQ 416.
Regarding claim 23, Simon discloses wherein at least one of the plurality of lumens is valveless (fig. 3, none of the lumens have valves).
Regarding claim 38, Simon, as modified by Siewert, fails to teach a kit comprising a drainage device according to claim 1 and complimentary forceps and/or blade and/or inserter.
However, Simon teaches wherein forceps are used to open the incision, and using a knife to make said incision (paragraph 0075).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that it involves a kit comprising the device according to claim 1 and complimentary forceps and blade for the purpose of providing a suitable package to perform the surgery.
Regarding claim 40, Simon discloses the device further comprising generally planar extensions (120, 125) projecting from the multi-lumen tube intermediate the first and second ends (fig. 3, first and second barb elements 120 and 125 on each side of the shunt, paragraph 0068).
Regarding claim 41, Simon, as modified by Siewert, discloses wherein the at least one aperture is located between the generally planar extensions and the first end (Siewert grants the benefit of having the aperture away from the first end as disclosed in the analysis of claim 1 above, and the first end and the planar extensions of Simon would then have the aperture in between.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon to have the at least one aperture in the sidewall as opposed to the first end, such that wherein the at least one aperture is located between the generally planar extensions and the first end, as suggested by Siewert, for the purpose of providing a suitable location that can restrict flow to prevent hypotension (see Siewert, paragraph 0049, “In order to limit the flow of the aqueous humor, holes 141 that are covered by the overlying membrane 20 are arranged as radial inflow openings that are distributed around the periphery of the base body 14. As a result, even after the complete degradation of the membrane 20, flow resistance required for the prevention of hypotension can be maintained.”, thus suggesting that the positioning of the openings also contributes to flow resistance).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Siewert, Yaron, Horvath, and Suson, and further in view of Allan (US 6186974).
Regarding claim 2, Simon fails to teach wherein a shape of the cross-section at the outer surface is an ellipse.
However, Allan teaches a glaucoma treatment device (abstract) wherein a shape of the cross section at the outer surface is an ellipse (col. 5, lines 1-8, “Preferably, however, the shape is oval or elliptical”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that a shape of the cross-section at the outer surface is an ellipse, as taught by Allan, for the purpose of providing a means of reducing leakage of aqueous humor (see Allan, col. 3, lines 10-20), and since it has been held that the shape of the cross section is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed lumen was significant, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and MPEP 2144.04(IV).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Siewert, Yaron, Horvath, and Suson, and further in view of Rubeinstein (US 5433701).
Regarding claim 3, Simon is silent to wherein the multi-lumen tube is anisotropic in bending about two axes each perpendicular to the longitudinal axis.
However, Rubinstein teaches wherein the multi-lumen tube has a greater flexibility in latitude bending past the longitudinal axis (col. 4, lines 53-62, “By varying the dimension of channels 22, it is possible to provide greater flexibility in the total dimension of channels 22, it is possible to provide greater flexibility in the total dimension of channels 22, thus allowing the surgeon greater latitude in 10 selecting the amount of drainage to be effected by implant 10”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that the multi-lumen tube is anisotropic in bending about two axes each perpendicular to the longitudinal axis, as taught by Rubinstein, for the purpose of providing a suitable structure that allows greater latitude in selecting the amount of drainage (see Rubinstein, col. 4, lines 53-62)
Regarding claim 4, Simon discloses wherein the multi-lumen tube has a width and a height (fig. 3, tube has a width and height), and the plurality of lumen are spaced in the width dimension (fig. 3, lumens are spaced in the width direction), but fails to teach wherein the multi-lumen tube has greater bending flexibility in a plane including the height dimension than in a plane including the width dimension.
However, Rubinstein teaches wherein the multi-lumen tube has greater flexibility including the height dimension than in a plane including the width dimension (col. 4, lines 53-62, “thus allowing the surgeon greater latitude in 10 selecting the amount of drainage to be effected by implant 10.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that the multi-lumen tube has greater bending flexibility in a plane including the height dimension than in a plane including the width dimension, as taught by Rubinstein, for the purpose of providing a suitable structure that allows greater latitude in selecting the amount of drainage (see Rubinstein, col. 4, lines 53-62)
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Siewert, Yaron, Horvath, and Suson, and further in view of Bigler (US 20170348148).
Regarding claim 7, Simon, as modified by Siewert, fails to teach wherein the at least one aperture comprises a plurality of the apertures.
However, Bigler teaches a drainage device (abstract) that has a plurality of drainage holes (7) along the lumen of the drainage tube (4) (fig. 1A, plurality of drainage holes 7, paragraph 0048)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that the at least one aperture comprises a plurality of apertures, as suggested by Bigler, for the purpose of providing a suitable means of increasing fluid drainage, and since it has been held that a mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 9¸ Simon, as modified by Siewert and Horvath, fails to teach wherein said at least one of the lumen has the plurality of the apertures spaced along the length of the multi-lumen tube at respective selected distances.
However, Bigler teaches wherein the plurality of apertures (7) are spaced along the length of the multi-lumen tube.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon in view of Bigler such that the plurality of apertures are spaced along the length of the multi-lumen tube at selected distances, as taught by Bigler, for the purpose of providing a suitable means of increasing fluid drainage, and since it has been held that a mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Siewert, Yaron, Horvath, and Suson, and further in view of Mahmud (GB 2296663). Yaron (US 20100274259) is used as extrinsic evidence.
Regarding claim 17, Simon does not teach wherein two or more of the lumen have different internal diameters.
However, Mahmud teaches a drainage device for alleviating excess ophthalmic fluid pressure (abstract) wherein two lumen (15, 15’) have different internal diameters (fig. 1, passages 15 and 15 have different circular cross-sectional sizes, pg. 6, 3rd paragraph)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that two or more of the lumen have different internal diameters, as taught by Mahmud, for the purpose of facilitating a beveled shape (see Mahmud, pg. 6, 3rd paragraph) which is known in the art for aiding implantation through tissue (see Yaron, paragraph 0129, “The beveled surface 236 can aid in implantation through tissue”).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Siewert, Yaron, Horvath, and Suson, and further in view of Sponsell (US 9381112).
Regarding claim 20, Simon is silent to wherein the multi-lumen tube includes at least one of plastics material and silicone.
However, Sponsell teaches wherein tubing is usually made of biocompatible materials such as silicone (col. 6, lines 23-38).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the multi-lumen tube of Simon such that it includes silicone, as taught by Sponsell, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 27 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Siewert, Yaron Horvath, and Suson, and further in view of Ahmed (US 20170348151).
Regarding claim 27, Simon fails to teach the device further comprising a plate adapted to locate on the eye, and wherein the first end of the multi-lumen tube opens in the underside of the plate.
However, Ahmed teaches a device for treating glaucoma (abstract) that comprises a plate (108) adapted to locate on the eye (fig. 13, plate 108, with fig. 3 showing a plate on an eyeball), wherein the first end of the tube opens in an underside of the plate (fig. 14, sidewalls 1402 of bottom plate 200 configured to receive tube 106, paragraph 0083. Bottom plate 200 is used with top plate 108).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon such that t comprises a plate adapted to locate on the eye, and wherein the first end of the multi-lumen tube opens in the underside of the plate, as taught by Ahmed, for the purpose of providing a suitable structure that allows for Simon to form a bleb in a location known in the art that lets the fluid be absorbed by the surrounding tissue via the scleral venous system (see Ahmed, paragraph 0042).
Regarding claim 35, Simon discloses a method for treating glaucoma or controlling intraocular pressure in a patient's eye by implantation with a drainage device in the patient’s eye (abstract), wherein the drainage device comprises a flexible multi-lumen tube (fig. 3, implant with channels from inflow port 112A to outflow port 112B) having an upper surface (fig. 3, shunt 110A has an upper surface), a first end (Fig. 3, first end near inflow port 112A), a second end opposite the first end (Fig. 3, outflow port 112B denotes second opposite end), a longitudinal axis through the first end and the second end and including at least a first lumen and a second lumen (fig. 3, longitudinal axis from the ports 112A and 112B, with 4 lumens spanning from left to right), a plurality of lumen extending between the first end and the second end (fig. 3 shows multiple lumens through port 112A to port 112B), and an outer surface extending between the first end and the second end (fig. 3, outer surface made outside the lumen), wherein a cross-section perpendicular to the longitudinal axis has a non-circular shape at the outer surface (fig. 3, cross section is an elongated slot with curved ends ) , wherein the aperture defines an open aperture area (fig. 3 shows opening at 112A as an open aperture)
positioning the first end of the drainage device in the anterior chamber of the patient's eye (fig. 7, shows inflow end proximate the angle of the anterior chamber), and positioning the second end of the drainage device in the subconjunctival space of the patient's eye (fig. 7 shows the device being underneath the conjunctiva), and
providing a fluid path defined from outside the multi-lumen tube, through the open aperture area of the at least one aperture and second lumen, and to an open end of the second lumen at the second end (fig. 3 shows a flow path leading from outside 112A, into 112A through the lumen and out of 112B).
Simon discloses openings that control the flow rate of aqueous humor through the drainage device (paragraph 0057 discloses inflow ports 112A, which “control” flow rate via their geometry), and appears to teach wherein the cross-section perpendicular to the longitudinal axis has an aspect ratio of at least 3:1,
but fails to teach the method wherein the tube has a sealed first end with a beveled end surface, wherein the first lumen is sealed at the first end by the beveled end surface, wherein the second lumen is initially sealed and comprises at least one aperture subsequently formed therein through the beveled end surface or the outer surface prior to implantation, wherein the at least one aperture is and located along a selected distance between the first end and the second end, wherein the at least one aperture fluidly connects the second end of the multi-lumen tube to outside the multi-lumen tube through said at least one of the lumens to control the flow rate of aqueous humor through the drainage device, and wherein the aperture is at a selected distance between the first end and the second end wherein the selected distance is calculated according to a preoperative intraocular pressure measurement and a desired pressure reduction to achieve a desired therapeutic flow rate of aqueous humor through the drainage device, the method comprising positioning the second end of the drainage device in the subconjunctival space of the patient's eye.
However, if this is not clearly envisioned by the applicant, there is no evidence of record that establishes that changing aspect ratio would result in a difference in function of the Simon device. Further, a person having ordinary skill in the art, being faced with modifying the cross-section of Simon, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the ratio may be 3:1 and offers other acceptable ranges (paragraph 0020, “at least 3:1, or at least 4:1, or at least 5:1… at least 6:1, or at least 7:1, or at least 8:1“).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Simon such that the cross-section has an aspect ratio of at least 3:1 as a matter if design choice within the skill of the art.
Simon fails to teach the method wherein the tube has a sealed first end with a beveled end surface, wherein the first lumen is sealed at the first end by the beveled end surface, wherein the second lumen is initially sealed and comprises at least one aperture subsequently formed therein through the beveled end surface or the outer surface prior to implantation, wherein the at least one aperture is and located along a selected distance between the first end and the second end, wherein the at least one aperture fluidly connects the second end of the multi-lumen tube to outside the multi-lumen tube through said at least one of the lumens to control the flow rate of aqueous humor through the drainage device, and wherein the aperture is at a selected distance between the first end and the second end wherein the selected distance is calculated according to a preoperative intraocular pressure measurement and a desired pressure reduction to achieve a desired therapeutic flow rate of aqueous humor through the drainage device, the method comprising positioning the second end of the drainage device in the subconjunctival space of the patient's eye, and providing a fluid path upon implantation away from the anterior chamber.
However, Siewert teaches a glaucoma drainage implant (abstract) that comprises a lumen that is sealed at a first end (fig. 8, lumen with closed end near section D) and comprises an aperture open in said lumen through a sidewall of the upper surface of the tube located along a length of the tube between the first end and the second end (fig. 9 shows at least one aperture 141 in the sidewalls), wherein the aperture fluidly connects to the second end of the tube outside of the tube through said lumen to control the flow rate of aqueous humor through the drainage device (fig. 9, opening 141 connects to the other end C shown in fig. 8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Simon such that at least one of the lumen is sealed at the first end, and further comprising at least one aperture open in said at least one of the lumen through a sidewall of upper surface of the multi-lumen tube located along a length of the multi-lumen tube between the first end and the second end, wherein the at least one aperture fluidly connects to the second end of the multi-lumen tube outside the multi-lumen tube through said at least one of the lumen to control the flow rate of aqueous humor through the drainage device, as suggested by Siewert, for the purpose of providing a suitable location that can restrict flow to prevent hypotension (see Siewert, paragraph 0049, “In order to limit the flow of the aqueous humor, holes 141 that are covered by the overlying membrane 20 are arranged as radial inflow openings that are distributed around the periphery of the base body 14. As a result, even after the complete degradation of the membrane 20, flow resistance required for the prevention of hypotension can be maintained.”, thus suggesting that the positioning of the openings also contributes to flow resistance).
Simon fails to teach wherein the aperture is at a selected distance between the first end and the second end wherein the selected distance is calculated according to a preoperative intraocular pressure measurement and a desired pressure reduction to achieve a desired therapeutic flow rate of aqueous humor through the drainage device, the method comprising positioning the second end of the drainage device in the subconjunctival space of the patient’s eye, and providing a fluid path upon implantation away from the anterior chamber.
However, Ahmed teaches a method for treating glaucoma (abstract) that drains fluid from the anterior chamber (401) to the subconjunctival space (fig. 4, fluid drains from anterior chamber 401 into space between sclera 400 and conjunctiva 402).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Simon such that it comprises positioning the second end of the drainage device in the subconjunctival space of the patient’s eye and providing a fluid path upon implantation away from the anterior chamber, as taught by Ahmed, for the purpose of providing a suitable method that places the device in a known region for forming a bleb in an area that absorbs it in the surrounding tissue via the scleral venous system (paragraph 0042).
Simon, as modified by Siewert, is silent to wherein the aperture is at a selected distance between the first end and the second end, wherein the selected distance is calculated according to a preoperative intraocular pressure measurement and a desired pressure reduction to achieve a desired therapeutic flow rate.
However, Horvath teaches wherein the flow rate of a shunt can be altered by cutting the shunt to increase the flow through the shunt (paragraph 0129). Such as cut would change the distance of the aperture between the first end and the second end, and this decision appears to be done for a desired therapeutic flow rate. Paragraph 0128 describes that if intraocular pressure is at an undesirable level, the clinician can modify the shunt accordingly. Lastly, paragraph 0178 describes that laminar flow/flow rate through the tube can be calculated using the Hagen-Poiseuille equation as part of the design considerations of the shunt, notably when it comes to the length of the channel. Thus. Horvath teaches wherein the distance of the opening from the second end is based on calculated flow rate and desired reduction in intraocular pressure.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Simon in view of Siewert such that the aperture is at a selected distance between the first end and the second end, wherein the selected distance is calculated according to a preoperative intraocular pressure measurement and a desired pressure reduction to achieve a desired therapeutic flow rate., as taught by Horvath, for the purpose of providing a suitable means of granting control of the flow rate of the shunt (see Horvath, paragraph 0178).
Simon, as modified by Siewert, does not teach the tube having a sealed first end with a bevel end surface, wherein the first lumen is sealed at the first end by the beveled end surface.
However, Yaron teaches wherein the first end is beveled, and/or is beveled at both ends (paragraph 0015).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon in view of Siewert such that the multi-lumen tube has a beveled end surface, as taught by Yaron, for the purpose of providing a suitable structure that aids in implantation through tissue and prevent clogging when faced away from the iris (see Yaron, paragraph 0129).
Simon, as modified by Siewert, is silent to wherein the second lumen is initially sealed and the aperture is subsequently formed therein prior to implantation.
However, Suson teaches an ocular implant (abstract) that teaches wherein an initially sealed reservoir can have openings or perforations creates with a laser after implantation, and suggests openings or perforations may be placed in the reservoir prior to implantation (col. 3, lines 65-67 and col. 4, lines 1-11, “The flow rate of aqueous humor through the device may be initiated and thereafter periodically adjusted in a linear manner at any time after implantation in order to increase the flow rate of aqueous humor and thereby lower intraocular pressure, by placing one or more openings or perforations in the reservoir. If the reservoir is located outside of the eye, the openings or perforations may be created by non-mechanical means such as a laser. Additionally, one or more openings or perforations may be placed in the reservoir prior to implantation, allowing a small rate of flow of aqueous humor from the device, but at a low level which is insufficient to relieve all of the intraocular pressure due to glaucoma.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Simon in view of Siewert such that the second lumen is initially sealed and the aperture is subsequently formed therein prior to implantation, as suggested by Suson, for the purpose of providing a means of initiating and thereafter adjusting flow rate through the implant (see Suson, col. 3, lines 65-67 and col. 4, lines 1-11)
Claim 37 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Siewert, Yaron Horvath, and Suson, and further in view of Brown (US 20040073156).
Regarding claim 37, Simon, as modified by Horvath, discloses opening the at least one aperture in the at least one lumen to control the flow rate of aqueous humor through the drainage device and provide calculated target reduction in intraocular pressure (paragraphs 0048-0049 discloses a laser beam at a photo-sacrificial portion of the shunt to open a microchannel in a similar embodiment, and Horvath teaches the calculated target reduction), but fails to teach the method comprising comparing an intraocular pressure measurement obtained from the patient with a threshold to calculate the calculated target reduction in intraocular pressure.
However, Brown teaches a device for reducing intraocular pressure (abstract) where factors including changing the microporous membrane are used by calculating a desirable intraocular pressure based on the factors involved (paragraph 0032, “Also, in preferred embodiments, the filter is comprised of a microporous membrane material. The microporous membrane comprises pores sized to block all bacteria, and pore number and length may be calculated to provide aqueous humor outflow that yields desirable intraocular pressure.”). One of ordinary skill in the art would also appreciate that different patients would require different levels of alleviation of pressure, thus one of ordinary skill in the art would be motivated to first measure an intraocular pressure, then determine a design for a desirable intraocular pressure.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Simon such that it comprises comparing an intraocular pressure measurement obtained from the patient with a threshold to calculate the calculated target reduction in intraocular pressure, as suggested by Brown, for the purpose of providing a suitable method that allows the practitioner to more precisely allow for a desirable intraocular pressure (see Brown, paragraph 0032).
Conclusion
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/Brandon W. Levy/Examiner, Art Unit 3781
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