Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 19-23, 26, 29-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams (US 2002/0156413).
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 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 (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).
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 ([0036]).
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, 7-10, 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 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),
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 ([0036]).
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]).
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 ([0036]).
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 ([0036]).
Claims 5-6, 11-12, 17-18, 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US 2002/0156413) in view of McAlister (US 2024/0065891).
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).
McAlister discloses a drainage device teaching an adhesive disposed between the membrane and the plate (200, [0106]), and wherein the adhesive is a thermoplastic ([0109]).
McAlister utilizes the adhesive in order to join the inner and outer edges of the device together ([0105]). 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 McAlister since both accomplishes the same end result of joining and sealing the edges of the device.
Regarding claims 11-12, 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 11), and wherein the adhesive is a thermoplastic (claim 12).
McAlister discloses a drainage device teaching an adhesive disposed between the membrane and the plate (200, [0106]), and wherein the adhesive is a thermoplastic ([0109]).
McAlister utilizes the adhesive in order to join the inner and outer edges of the device together ([0105]). 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 McAlister 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 11), and wherein the adhesive is a thermoplastic (claim 12).
McAlister discloses a drainage device teaching an adhesive disposed between the membrane and the plate (200, [0106]), and wherein the adhesive is a thermoplastic ([0109]).
McAlister utilizes the adhesive in order to join the inner and outer edges of the device together ([0105]). 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 McAlister since both accomplishes the same end result of joining and sealing the edges of the device.
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 11), and wherein the adhesive is a thermoplastic (claim 12).
McAlister discloses a drainage device teaching an adhesive disposed between the membrane and the plate (200, [0106]), and wherein the adhesive is a thermoplastic ([0109]).
McAlister utilizes the adhesive in order to join the inner and outer edges of the device together ([0105]). 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 McAlister 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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/KAI H WENG/Primary Examiner, Art Unit 3781