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 .
Response to Arguments
Applicant’s arguments, filed 13 July 2026, with respect to claim 7 have been fully considered and are persuasive. Applicant has overcome the prior art by disqualifying McAlister under 35 USC 102(b)(2)(C) exception. The rejection of claims 7-10 and 12 has been withdrawn. Accordingly, this action is a second Non-Final Rejection.
Applicant’s arguments with respect to claim(s) 1-6, 19-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments regarding claims 13-18, and 26-33 have been fully considered but they are not persuasive.
Regarding claims 13-18, Applicant argues the range of the thickness cannot be routinely optimized. The MPEP has recognized that the change in size/proportion rationale as a legal precedent as source of supporting rationale (MPEP 2144.04). 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). In the instant case, the device of Williams would not operate differently with the claimed thickness and the device would function appropriately having the claimed thicknesses. Further, applicant places no criticality on the range claimed, indicating simply that the thickness “about” the claimed ranges (specification pp. [00107]). To overcome this obviousness rationale of change in size, Applicant must demonstrate the prior art device would perform differently with the claimed dimensions.
Regarding claims 26-33, Applicant argues Williams does not teach “the first surface of the first body component is attached to an outer surface of the second body component” since Williams only teaches edge to edge peripheral attachment of the membrane to disk. It is noted that the claimed limitation does not specifically require that the first surface and second surface be entirely attached or that specific regions be in contact but only recites that the first surface is attached to the outer surface of the second body component. Examiner submits that the peripheral attachment in Williams meets the abovementioned claim limitation of due to Williams disclosing the regions being bonded together ([0028]).
Claims 1-10, 12-33 are examined on the merits.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1, line 6, “the first por3osity” should be corrected to –the first porosity--.
Appropriate correction is required.
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 (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 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)(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.
Claims 26, 29-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams (US 2002/0156413).
Regarding claim 26, Williams discloses a drainage device for draining a fluid from an eye to a tissue external to the eye, the drainage device being implantable at least in part within a tissue of the eye (figures 1-2, [0016]) and comprising:
a body portion (9) comprising:
a first body component (11 and 12, figure 2, [0028]) having a first surface with a first porosity and a second surface with a second porosity that is greater than the first porosity ([0028], [0030]), the second surface opposing the first surface (figure 2), and
a second body component (13, figure 2) having a third porosity that is less than the first porosity ([0032], polypropylene, this layer not disclosed as porous and thus has less pores than the other surfaces) and defining a reservoir of the body portion ([0028]), wherein the first surface of the first body component is attached to an outer surface of the second body component ([0028]); and
a conduit (7) having an end portion fluidly coupled with the reservoir and insertable into the eye to facilitate a drainage of the fluid into the conduit (figures 1-2),
wherein the second surface of the first body component with the second porosity includes at least one ingrowth surface region for facilitating ingrowth of tissue external to the eye, and the first surface of the first body component with the first porosity is configured to inhibit the ingrowth of tissue external to the eye ([0033]).
Regarding claim 29, Williams discloses wherein the first surface with the first porosity is configured to inhibit the ingrowth of the tissue external to the eye ([0033]).
Regarding claim 30, Williams discloses wherein the second surface further includes at least one low-porosity region for inhibiting the ingrowth of the tissue external to the eye ([0030], porosity varies across the material, some areas would naturally be low-porosity which would inhibit growth since the range goes from 1 micrometer to 500 micrometer, the 1 micrometer area would naturally inhibit growth).
Regarding claim 31, Williams discloses wherein the first body component comprises a plurality of internal regions with porosities that are greater than the first porosity and less than the second porosity (both layers 11 and 12 have different porosity, [0032-0033]).
Regarding claim 32, Williams discloses wherein the conduit is attached to a periphery of the body portion (figure 2 shows the conduit is on and extends from the periphery of the body).
Regarding claim 33, Williams discloses wherein the conduit is attached to the body portion across a portion of a cross-sectional length of the body portion (figure 2, the conduit is attached across a portion of a length of the body).
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.
Claims 1-4, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2002/0156413).
Regarding claim 1, Williams discloses a drainage device for draining a fluid from an eye to a tissue external to the eye (figures 1-2), the drainage device being implantable at least in part within a tissue of the eye ([0016]) and comprising:
a body portion (9) comprising:
a membrane (11 and 12, figure 2, [0028]) having a first surface (top surface of 11) with a first porosity and a second surface (bottom of 12) with a second porosity that is greater than the first porosity ([0028], [0030]), the second surface opposing the first surface (figure 2), wherein the membrane comprises a plurality of internal regions with porosity that are greater than the first porosity and less than the second porosity (the area between the top surface and bottom surface has pores as the layers have regions of porosity ([0028], the mixing of pores of a higher diameter with a smaller diameter should average a pore size that is between the first and second pore sizes); and
a plate (13, figure 2) having a porosity less than the first porosity (contains polypropylene, not disclosed to be porous),
wherein the membrane is more flexible than the plate ([0030, the membrane made of polyurethane and silicone elastomer more porous than polypropylene),
the membrane and the plate defining a reservoir of the body portion ([0028]); and
a conduit (7) having an end portion fluidly coupled with the reservoir and insertable into the eye to facilitate a drainage of the fluid into the conduit ([0029]),
wherein the second surface of the membrane with the second porosity includes at least one ingrowth surface region for facilitating ingrowth of tissue external to the eye ([0033], the region includes pores and channels to allow blood vessels to pass and stimulate new vessels).
While Williams teaches the difference in porosity, Williams does not teach wherein the membrane has a first thickness from about 25 micrometers to about 125 micrometers, and the plate has a second thickness from about 0.8 mm to about 2.0 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Williams to have the desired thickness of the membrane and plate 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). In the instant case, the device of Williams would not operate differently with the claimed thickness and the device would function appropriately having the claimed thicknesses. Further, applicant places no criticality on the range claimed, indicating simply that the thickness “about” the claimed ranges (specification pp. [00107]).
Regarding claim 2, Williams discloses wherein the plate is nonporous ([0032], polypropylene plate is not porous).
Regarding claim 3, Williams discloses the plate comprising one or more of: silicone or polypropylene ([0032]).
Regarding claim 4, Williams discloses membrane comprising one or more of: expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluorine (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or acrylic copolymer ([0030]).
Regarding claim 13, Williams discloses a drainage device for draining a fluid from an eye to a tissue external to the eye (figures 1-2), the drainage device being implantable at least in part within a tissue of the eye ([0016]) and comprising:
a body portion (9) comprising:
a membrane (11 and 12, figure 2, [0028]) having a first surface with a first porosity and a second surface with a second porosity that is greater than the first porosity ([0028], [0030]), the second surface opposing the first surface (figure 2), and
a plate (13, figure 2) having a porosity less than the first porosity (contains polypropylene, not disclosed to be porous),
the membrane and the plate defining a reservoir of the body portion ([0028]); and
a conduit (7) at least partially defined by the membrane and the plate (figure 2), fluidly coupled with the reservoir and insertable into the eye to facilitate a drainage of the fluid into the conduit ([0029]),
wherein the second surface of the membrane with the second porosity includes at least one ingrowth surface region for facilitating ingrowth of tissue external to the eye ([0033], the region includes pores and channels to allow blood vessels to pass and stimulate new vessels).
While Williams teaches the difference in porosity, Williams does not teach wherein the membrane has a first thickness from about 25 micrometers to about 125 micrometers, and the plate has a second thickness from about 0.05 micrometer to about 10 micrometer.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Williams to have the desired thickness of the membrane and plate 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). In the instant case, the device of Williams would not operate differently with the claimed thickness and the device would function appropriately having the claimed thicknesses. Further, applicant places no criticality on the range claimed, indicating simply that the thickness “about” the claimed ranges (specification pp. [00107]).
Regarding claim 14, Williams discloses wherein the plate is nonporous ([0032], polypropylene plate is not porous).
Regarding claim 15, Williams discloses the plate comprising one or more of: silicone or polypropylene ([0032]).
Regarding claim 16, Williams discloses membrane comprising one or more of: expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluorine (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or acrylic copolymer ([0030]).
Claims 5-10, 12, 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2002/0156413) in view of Roeber (US 2018/0263818).
Regarding claims 5-6, Williams discloses the edge of the plate and membrane are fused/sealed ([0028]) but does not teach the device further comprising an adhesive disposed between the membrane and the plate (claim 5), and wherein the adhesive is a thermoplastic (claim 6).
Roeber discloses a drainage device teaching an adhesive disposed between the membrane (1100) and the plate (1400, [086]), and wherein the adhesive is a thermoplastic ([0108]).
Roeber utilizes the adhesive among many of the methods to join the device together ([0086],[0108]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify and substitute the fusing of Williams edges with the joining by adhesive of Roeber since both accomplishes the same end result of joining and sealing the edges of the device.
Regarding claim 7, Williams discloses a drainage device for draining a fluid from an eye to a tissue external to the eye (figures 1-2), the drainage device being implantable at least in part within a tissue of the eye ([0016]) and comprising:
a body portion (9) comprising:
a membrane (12, figure 2, [0028]) having a porosity such that the membrane is configured to allow fluid from the eye to pass therethrough and inhibit the ingrowth of tissue external to the eye ([0032-0033]), and
a plate (13, figure 2) having a porosity less than the porosity of the membrane (contains polypropylene, not disclosed to be porous),
wherein the membrane is more flexible than the plate ([0030, the membrane made of polyurethane and silicone elastomer more porous than polypropylene),
the membrane and the plate defining a reservoir of the body portion ([0028]); and
a conduit (7) having an end portion fluidly coupled with the reservoir and insertable into the eye to facilitate a drainage of the fluid into the conduit ([0029]).
While Williams teaches the difference in porosity, Williams does not teach wherein the membrane has a first thickness from about 25 micrometers to about 125 micrometers, and the plate has a second thickness from about 0.8 mm to about 2.0 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Williams to have the desired thickness of the membrane and plate 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). In the instant case, the device of Williams would not operate differently with the claimed thickness and the device would function appropriately having the claimed thicknesses. Further, applicant places no criticality on the range claimed, indicating simply that the thickness “about” the claimed ranges (specification pp. [00107]).
Williams discloses the edge of the plate and membrane are fused/sealed ([0028]) but does not teach the device further comprising an adhesive disposed between the membrane and the plate.
Roeber discloses a drainage device teaching an adhesive disposed between the membrane (1100) and the plate (1400, [086]).
Roeber utilizes the adhesive among many of the methods to join the device together ([0086],[0108]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify and substitute the fusing of Williams edges with the joining by adhesive of Roeber since both accomplishes the same end result of joining and sealing the edges of the device.
Regarding claim 8, Williams discloses wherein the plate is nonporous ([0032], polypropylene plate is not porous).
Regarding claim 9, Williams discloses the plate comprising one or more of: silicone or polypropylene ([0032]).
Regarding claim 10, Williams discloses membrane comprising one or more of: expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluorine (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or acrylic copolymer ([0030]).
Regarding claim 12, Williams discloses the edge of the plate and membrane are fused/sealed ([0028]) but does not teach the device further comprising wherein the adhesive is a thermoplastic.
Roeber discloses a drainage device teaching an adhesive disposed between the membrane (1100) and the plate (1400, [086]), and wherein the adhesive is a thermoplastic ([0108]).
Roeber utilizes the adhesive among many of the methods to join the device together ([0086],[0108]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify and substitute the fusing of Williams edges with the joining by adhesive of Roeber since both accomplishes the same end result of joining and sealing the edges of the device.
Regarding claims 17-18, Williams discloses the edge of the plate and membrane are fused/sealed ([0028]) but does not teach the device further comprising an adhesive disposed between the membrane and the plate (claim 17), and wherein the adhesive is a thermoplastic (claim 18).
Roeber discloses a drainage device teaching an adhesive disposed between the membrane (1100) and the plate (1400, [086]), and wherein the adhesive is a thermoplastic ([0108]).
Roeber utilizes the adhesive among many of the methods to join the device together ([0086],[0108]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify and substitute the fusing of Williams edges with the joining by adhesive of Roeber since both accomplishes the same end result of joining and sealing the edges of the device.
Regarding claim 19, Williams discloses drainage device for draining a fluid from an eye to a tissue external to the eye, the drainage device being implantable at least in part within a tissue of the eye (figures 1-2, [0016]) and comprising:
a collapsible body portion (9, material is polymeric and can be collapsed when flexed, [0030]) comprising:
a flexible first body component (11 and 12, figure 2, [0028], [0030]-polyurethane is flexible) having a first surface with a first porosity and a second surface with a second porosity that is greater than the first porosity ([0028], [0030]), the second surface opposing the first surface (figure 2), and
a second body component (13, figure 2, [0032] polypropylene recited as material does not mention if the specific type of polypropylene is flexible) having a third porosity that is less than the first porosity (not disclosed as porous, made from polypropylene, [0032])
the first and second body components defining a reservoir of the collapsible body portion ([0028]); and
a conduit (7) having an end portion fluidly coupled with the reservoir and insertable into the eye to facilitate a drainage of the fluid into the conduit ([0029]),
wherein the second surface of the first body component with the second porosity includes at least one ingrowth surface region for facilitating ingrowth of tissue external to the eye (0033], the region includes pores and channels to allow blood vessels to pass and stimulate new vessels).
Williams does not disclose the second body component is flexible.
Roeber discloses a drainage device and teaches the second body component is made from flexible material ([0086]).
Roeber utilizes the flexible material in order to avoid relative moment of the device and surrounding tissue ([0003]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify and substitute the Williams material in order to avoid movement of the device with the area of implantation.
Regarding claim 20, Williams discloses wherein the plate is nonporous ([0032], polypropylene plate is not porous).
Regarding claim 21, Williams discloses the plate comprising one or more of: silicone or polypropylene ([0032]).
Regarding claim 22, Williams discloses the second body component having a greater stiffness than first body component (polypropylene harder than polyurethane ([0028, [0032])).
Regarding claim 23, Williams discloses membrane comprising one or more of: expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluorine (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or acrylic copolymer ([0030]).
Regarding claims 24-25, Williams discloses the edge of the plate and membrane are fused/sealed ([0028]) but does not teach the device further comprising an adhesive disposed between the membrane and the plate (claim 24), and wherein the adhesive is a thermoplastic (claim 25).
Roeber discloses a drainage device teaching an adhesive disposed between the membrane (1100) and the plate (1400, [086]), and wherein the adhesive is a thermoplastic ([0108]).
Roeber utilizes the adhesive among many of the methods to join the device together ([0086],[0108]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify and substitute the fusing of Williams edges with the joining by adhesive of Roeber since both accomplishes the same end result of joining and sealing the edges of the device.
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2002/0156413) in view of Camras (US 10201451).
Regarding claim 27, Williams does not disclose the second body component comprising a plurality of subcomponents attached together.
Camras discloses a glaucoma shunt and teaches the second body component (74) comprising a plurality of subcomponents attached together (74 includes a section that extends downward and on the bottom side of the reservoir (figure 8, col 6, lines 34-47).
It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Williams with the Camras device having separate plurality of subcomponents sine it has been held that to make separable is obvious In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (MPEP 2144). In this case, one of ordinary skill in the art would want the plurality of parts separable for accessing the end of the device or assemble/disassemble the device when desired.
Regarding claim 28, Williams does not disclose further comprising an open-ended valve enclosed in the body portion, fluidly coupled with the conduit, and partially defining the reservoir.
Camras teaches an open-ended valve (82) enclosed in the body portion, fluidly coupled with the conduit, and partially defining the reservoir (figure 7).
Camras utilizes the valve to control the opening and the movement of fluid (col 6, lines 34-47). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Williams with the Camras device to control the movement of fluid when desired.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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