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 .
In light of the amendments to the claims filed 09/11/2025 wherein claims 1, 21, and 25 were amended, claims 1-2, 5-15, 17, 19-25, and 27-28 are pending in the instant application and are examined on the merits herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/11/2025 has been entered.
Priority
The instant application is a 371 of PCT/US2019/048760 filed 08/29/2019 which claims priority to U.S. Provisional Application no. 62/724,180 filed on 08/29/2018.
Claims 1-2, 5-15, 17, 19-25, and 27-28 receive priority to the prior-filed application, filed on 08/29/2018.
Response to Arguments
Claim Rejections under 35 U.S.C. 103
Applicant’s arguments with respect to independent claims 1, 21, and 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: the pore sizes disclosed in Silvestrini. The amendments to the claims have necessitated new grounds of rejection. In the new grounds of rejection, the independent claims are rejected over Nissan in view of Jacob.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites the limitation “…wherein both the exterior of the compliant fluid conduit and a luminal wall surface of the lumen comprise a microporous material the luminal wall surface being impermeable to ocular fluid and resistant to tissue ingrowth and attachment” in ln. 14-16. This should read, “…wherein both the exterior of the compliant fluid conduit and a luminal wall surface of the lumen comprise a microporous material, the luminal wall surface being impermeable to ocular fluid and resistant to tissue ingrowth and attachment”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-15, 17, 19-25, and 27-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites the limitation “a compliant fluid conduit…wherein the thickness is about 100 microns or less…” in ln. 6. The specification discloses the thickness of the wall of the fluid conduit may have a thickness that is constant or may vary along its length and that a variety of dimensions are contemplated and considered to be within the purview of the invention (para. 00057); however, the specification fails to disclose specific dimensions for the thickness. Claims 21 and 25 recite similar limitations to that of claim 1, and are rejected for substantially the same reason.
Claims 2, 5-15, 17, 19-20, and 27-28 are rejected for depending upon rejected base claims.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5-12, 17, 19-25, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over US/2013/0325024 A1 to Nissan in view of U.S. Patent no. 5,882,327 A to Jacob.
Regarding claim 1, Nissan discloses a medical device (Fig. 3, 180 ocular implant; para. 0033, 190 fluid conduit may be implanted independently of 185 plate) comprising: a compliant fluid conduit (Fig. 4, 190 fluid conduit) configured for implantation within a biological tissue (para. 0033), the compliant fluid conduit including a single sheet of material with portions of varying porosity (para. 0039; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region) having a first end (Fig. 3 showing first end of 190 fluid conduit in anterior chamber of the eye), a second end (Fig. 3 showing second end of 190 fluid conduit opposite first end of 190 fluid conduit), a lumen (Fig. 4, 194 lumen wall), a thickness (Fig. 4 showing thickness of 190 fluid conduit), and an exterior (Fig. 4, 196 exterior) having a microstructure that is configured to permit cellular ingrowth therein (para. 0047 ln. 16-27), wherein the microstructure includes a plurality of pores (para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region); wherein the first end is configured to be inserted into an eye of a patient to allow ocular fluid to drain from the eye (para. 0031 ln. 7-10; Fig. 3 showing first end of 190 fluid conduit in anterior chamber of the eye); and wherein the second end is configured to be inserted into an ocular venous system of the patient to allow the ocular fluid drained from the eye to flow directly into the ocular venous system (para. 0030 ln. 6-11, drainage site of 180 ocular implant may be the episcleral vein; para. 0033, 190 fluid conduit may be implanted independently of 185 plate for the treatment or relief of swelling, fluid retention, or a high pressure condition and may be sized to provide appropriate relief to the treated condition; para. 0055 ln. 1-12), wherein both the exterior of the compliant fluid conduit and a luminal wall surface of the lumen comprise a material (para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region), the luminal wall surface being impermeable to ocular fluid and resistant to tissue ingrowth and attachment (para. 0047 ln. 16-27; para. 0050 ln. 10-15, second region [194 lumen] may be about 0-49% porous making it substantially impermeable to ocular fluid; para. 0058, “about” refers to all whole integers within the range and each tenth).
Nissan differs from the instantly claimed invention in that Nissan fails to explicitly disclose wherein the thickness is about 100 microns or less.
Nissan discloses that the compliant fluid conduit has two openings, one at each end, and one lumen connecting the openings, with each opening and the lumen having a diameter of about 180-400 microns (Fig. 4, 190 fluid conduit comprising 225 openings and 194 lumen; para. 0038). Nissan further discloses that the compliant fluid conduit has an outer diameter of about 600 microns (para. 0038). These teachings together seem to suggest that the thickness of the compliant fluid conduit has a thickness between 100-210 microns (outer diameter formed of the diameter of the openings or lumen and the thickness of the compliant fluid conduit on two opposite sides).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of Nissan from between 100-210 microns to between about 100 microns or less 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). Further, applicant appears to have placed no criticality on the claimed range (see para. 00057 indicating that a variety of dimensions are contemplated).
Further, Nissan differs from the instantly claimed invention in that Nissan fails to disclose wherein the average pore size is about 20 microns and the material being microporous.
Nissan discloses the luminal wall surface comprising lower porosity than the exterior surface of the compliant fluid conduit and that differences in porosity can be created by differences in size (para. 0047 ln. 8-12; para. 0047 ln. 16-27).
Jacob teaches a fluid conduit comprising an exterior surface comprising a microstructure including a plurality of pores with an average pore size of 15-90 microns (Fig. 3, 12 porous ingrowth surface of 13 conduit; col. 5 ln. 61-67 and col. 6 ln. 1-52).
Jacob is considered to be analogous to the instantly claimed invention in that Jacob discloses a medical device for use in the eye. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the exterior surface of the fluid conduit of Nissan to have pores within the sizes as taught by Jacob, because Jacob teaches that this allows for cellular infiltration and collagen deposition through the pores and around the walls of the pores such that movement of the device is prevented not only from side to side but also perpendicularly to the scleral surface (col. 3 ln. 39-50).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size of the exterior surface of Nissan, as modified by Jacob, from between 15-90 microns to about 20 microns 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). Further, applicant appears to have placed no criticality on the claimed range (see para. 00074 indicating the pore sizes “may” be within the claimed range).
Regarding claim 2, the combination of Nissan and Jacob discloses the invention of claim 1, the combination further discloses: wherein a luminal wall surface of the lumen is configured to resist cellular ingrowth and attachment (Nissan: para. 0047 ln. 16-27)
Regarding claim 5, the combination of Nissan and Jacob discloses the invention of claim 1, the combination further discloses: wherein the compliant fluid conduit is a polymer tube (Nissan: para. 0036).
Regarding claim 6, the combination of Nissan and Jacob discloses the invention of claim 5, the combination further discloses: wherein the polymer tube includes a plurality of layers (Nissan: para. 0043 ln. 1-3, 192 fluid conduit may comprise 220 second tubular wall substantially encircling the exterior; para. 0044-0046).
Regarding claim 7, the combination of Nissan and Jacob discloses the invention of claim 6, the combination further discloses: wherein the plurality of layers include a first layer having a first microstructure (Nissan: first layer considered 192 fluid conduit; para. 0047-0050) and a second layer having a second microstructure (Nissan: second layer considered 220 second tubular wall; para. 0044-0045).
Regarding claim 8, the combination of Nissan and Jacob discloses the invention of claim 5, the combination further discloses: wherein the polymer tube comprises a fluoropolymer (Nissan: para. 0036).
Regarding claim 9, the combination of Nissan and Jacob discloses the invention of claim 8; however, the current combination of the prior art fails to disclose wherein the polymer tube comprises expanded polytetrafluoroethylene.
Nissan discloses the polymer tube comprising biostable materials including polyvinyl aromatics such as polytetrafluoroethylenes (para. 0036 ln. 21-44).
Jacob teaches a glaucoma implant comprising biocompatible materials such as expanded polytetrafluoroethylene (col. 3 ln. 13-15; col. 5 ln. 61-67 and col. 6 ln. 1-52).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the polymer tube of the combined invention of Nissan and Jacob to comprise expanded polytetrafluoroethylene as taught by Jacob in view of the disclosure in Nissan that the polymer tube can comprise biostable polymeric materials (para. 0036 ln. 21-44) and Jacob discloses that expanded polytetrafluoroethylene is a suitable polymer for cellular ingrowth (col. 5 ln. 61-67 and col. 6 ln. 1-52).
Regarding claim 10, the combination of Nissan and Jacob discloses the invention of claim 1, the combination further discloses: wherein the device operates to regulate an intraocular pressure of a patient's eye when implanted (Nissan: para. 0031 ln. 7-10; para. 0033 ln. 1-9).
Regarding claim 11, the combination of Nissan and Jacob discloses the invention of claim 1, the combination further discloses: wherein the compliant fluid conduit is configured to allow fluid egress from within an anterior chamber of a patient's eye when implanted (Nissan: para. 0030-0031; Fig. 3 showing first end of 190 fluid conduit in anterior chamber of the eye).
Regarding claim 12, the combination of Nissan and Jacob discloses the invention of claim 1, the combination further discloses: wherein the compliant fluid conduit comprises one of a plurality of lumens formed in a tubular structure (Nissan: para. 0043 ln. 1-3, 192 fluid conduit may comprise 220 second tubular wall substantially encircling the exterior; para. 0044-0046).
Regarding claim 17, the combination of Nissan and Jacob discloses the invention of claim 1, the combination further discloses: wherein the interior of the compliant fluid conduit includes a second portion of the microstructure that is configured to resist cellular ingrowth and attachment (Nissan: para. 0047 ln. 16-27; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region).
Regarding claim 19, the combination of Nissan and Jacob discloses the invention of claim 1, the combination further discloses: wherein the second end of the compliant fluid conduit is configured to be inserted into an episcleral vein of the eye (Nissan: Fig. 3 showing second end of 190 fluid conduit opposite first end of 190 fluid conduit; para. 0030 ln. 6-11, drainage site of 180 ocular implant may be the episcleral vein; para. 0033, 190 fluid conduit may be implanted independently of 185 plate for the treatment or relief of swelling, fluid retention, or a high pressure condition and may be sized to provide appropriate relief to the treated condition; para. 0055 ln. 1-12).
Regarding claim 20, the combination of Nissan and Jacob discloses the invention of claim 1, the combination further discloses: wherein the compliant fluid conduit is a synthetic polymeric material that is nonbioabsorbable (Nissan: para. 0036, 192 fluid conduit may be made of one or more polymers, biostable materials, biodegradable materials, or a combination thereof; therefore, Nissan may be made entirely of a synthetic polymeric material and may not be bioabsorbable).
Regarding claim 21, Nissan discloses a method of treating glaucoma (para. 0007 ln. 1-5; para. 0030 ln. 6-11, drainage site of 180 ocular implant may be the episcleral vein; para. 0033, 190 fluid conduit may be implanted independently of 185 plate for the treatment or relief of swelling, fluid retention, or a high pressure condition and may be sized to provide appropriate relief to the treated condition), the method comprising: providing a compliant fluid conduit including a single porous material (para. 0039; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region; Fig. 3-4, 190 fluid conduit) having a first end configured for insertion into an eye of a patient (Fig. 3 showing first end of 190 fluid conduit in anterior chamber of the eye; para. 0031 ln. 7-10), a second end configured for insertion into an ocular venous system of the patient (Fig. 3 showing second end of 190 fluid conduit opposite first end of 190 fluid conduit; para. 0030 ln. 6-11, drainage site of 180 ocular implant may be the episcleral vein; para. 0033, 190 fluid conduit may be implanted independently of 185 plate for the treatment or relief of swelling, fluid retention, or a high pressure condition and may be sized to provide appropriate relief to the treated condition; para. 0055 ln. 1-12), the compliant fluid conduit being configured for implantation within a biological tissue (para. 0033) and including an exterior surface (Fig. 4, 196 exterior) and a luminal wall surface (Fig. 4, 194 lumen wall) that include the single porous material (para. 0039; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region; Fig. 3-4, 190 fluid conduit), the single porous material having a microstructure defining a first portion having larger pores that forms the exterior surface of the compliant fluid conduit that is configured to permit cellular ingrowth therein (para. 0047 ln. 8-12; para. 0047 ln. 16-27; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region), and a second portion having smaller pores that forms the luminal wall surface of the compliant fluid conduit configured to resist cellular ingrowth (para. 0047 ln. 8-12; para. 0047 ln. 16-27; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region); inserting the first end into the eye of the patient such that the first end of the compliant fluid conduit accesses a fluid reservoir within the eye (para. 0031 ln. 7-10; Fig. 3 showing first end of 190 fluid conduit in anterior chamber of the eye); and inserting the second end of the compliant fluid conduit into the ocular venous system such that a fluid within the fluid reservoir within the eye is free to drain through the compliant fluid conduit into the ocular venous system (Fig. 3 showing second end of 190 fluid conduit opposite first end of 190 fluid conduit; para. 0030 ln. 6-11, drainage site of 180 ocular implant may be the episcleral vein; para. 0033, 190 fluid conduit may be implanted independently of 185 plate for the treatment or relief of swelling, fluid retention, or a high pressure condition and may be sized to provide appropriate relief to the treated condition; para. 0055 ln. 1-12).
Nissan differs from the instantly claimed invention in that Nissan fails to explicitly disclose wherein a thickness of the material is about 100 microns or less.
Nissan discloses that the compliant fluid conduit has two openings, one at each end, and one lumen connecting the openings, with each opening and the lumen having a diameter of about 180-400 microns (Fig. 4, 190 fluid conduit comprising 225 openings and 194 lumen; para. 0038). Nissan further discloses that the compliant fluid conduit has an outer diameter of about 600 microns (para. 0038). These teachings together seem to suggest that the thickness of the compliant fluid conduit has a thickness between 100-210 microns (outer diameter formed of the diameter of the openings or lumen and the thickness of the compliant fluid conduit on two opposite sides).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of Nissan from between 100-210 microns to between about 100 microns or less 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). Further, applicant appears to have placed no criticality on the claimed range (see para. 00057 indicating that a variety of dimensions are contemplated).
Further, Nissan differs from the instantly claimed invention in that Nissan fails to disclose wherein the larger pores have an average pore size of about 20 microns and the material being microporous.
Nissan discloses the luminal wall surface comprising lower porosity than the exterior surface of the compliant fluid conduit and that differences in porosity can be created by differences in size (para. 0047 ln. 8-12; para. 0047 ln. 16-27).
Jacob teaches a fluid conduit comprising an exterior surface comprising a microstructure including a plurality of pores with an average pore size of 15-90 microns (Fig. 3, 12 porous ingrowth surface of 13 conduit; col. 5 ln. 61-67 and col. 6 ln. 1-52).
Jacob is considered to be analogous to the instantly claimed invention in that Jacob discloses a medical device for use in the eye. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the exterior surface of the fluid conduit of Nissan to have pores within the sizes as taught by Jacob, because Jacob teaches that this allows for cellular infiltration and collagen deposition through the pores and around the walls of the pores such that movement of the device is prevented not only from side to side but also perpendicularly to the scleral surface (col. 3 ln. 39-50).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size of the exterior surface of Nissan, as modified by Jacob, from between 15-90 microns to about 20 microns 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). Further, applicant appears to have placed no criticality on the claimed range (see para. 00074 indicating the pore sizes “may” be within the claimed range).
Regarding claim 22, the combination of Nissan and Jacob discloses the method of claim 21, the combination further discloses: wherein inserting the first end of the compliant fluid conduit into the eye of the patient includes inserting the first end into an anterior chamber of the eye of the patient (Nissan: para. 0031 ln. 7-10; Fig. 3 showing first end of 190 fluid conduit in anterior chamber of the eye).
Regarding claim 23, the combination of Nissan and Jacob discloses the method of claim 21, the combination further discloses: wherein inserting the second end of the compliant fluid conduit into the ocular venous system includes inserting the second end into an episcleral vein of the eye (Nissan: Fig. 3 showing second end of 190 fluid conduit opposite first end of 190 fluid conduit; para. 0030 ln. 6-11, drainage site of 180 ocular implant may be the episcleral vein; para. 0033, 190 fluid conduit may be implanted independently of 185 plate for the treatment or relief of swelling, fluid retention, or a high pressure condition and may be sized to provide appropriate relief to the treated condition; para. 0055 ln. 1-12).
Regarding claim 24, the combination of Nissan and Jacob discloses the method of claim 21, the combination further discloses: wherein the compliant fluid conduit is a synthetic polymer material that is nonbioabsorbable (Nissan: para. 0036, 192 fluid conduit may be made of one or more polymers, biostable materials, biodegradable materials, or a combination thereof; therefore, Nissan may be made entirely of a synthetic polymeric material and may not be bioabsorbable).
Regarding claim 25, Nissan discloses a medical device (Fig. 3, 180 ocular implant; para. 0033, 190 fluid conduit may be implanted independently of 185 plate) comprising: a compliant fluid conduit (Fig. 4, 190 fluid conduit) configured for implantation within a biological tissue (para. 0033), the compliant fluid conduit including a single material having a microstructure with portions of varying porosity (para. 0039; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region) having a first end (Fig. 3 showing first end of 190 fluid conduit in anterior chamber of the eye), a second end (Fig. 3 showing second end of 190 fluid conduit opposite first end of 190 fluid conduit), a lumen (Fig. 4, 200 lumen defined by 194 lumen wall), a thickness (Fig. 4 showing thickness of 190 fluid conduit), and an exterior (Fig. 4, 196 exterior), wherein: a first portion of the microstructure includes a plurality of pores that includes the exterior and is configured to permit cellular ingrowth therein (para. 0047 ln. 8-12; para. 0047 ln. 16-27; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region), and a second portion of the microstructure includes a plurality of pores that includes a luminal wall surface and is configured to resist cellular ingrowth (para. 0047 ln. 8-12; para. 0047 ln. 16-27; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen wall is considered second region); wherein the first end is insertable into an eye of a patient to allow ocular fluid to drain from the eye (para. 0031 ln. 7-10; Fig. 3 showing first end of 190 fluid conduit in anterior chamber of the eye); and wherein the second end is insertable into an ocular venous system of the patient to allow the ocular fluid drained from the eye to flow directly into the ocular venous system (para. 0030 ln. 6-11, drainage site of 180 ocular implant may be the episcleral vein; para. 0033, 190 fluid conduit may be implanted independently of 185 plate for the treatment or relief of swelling, fluid retention, or a high pressure condition and may be sized to provide appropriate relief to the treated condition; para. 0055 ln. 1-12).
Nissan differs from the instantly claimed invention in that Nissan fails to explicitly disclose wherein the thickness is about 100 microns or less.
Nissan discloses that the compliant fluid conduit has two openings, one at each end, and one lumen connecting the openings, with each opening and the lumen having a diameter of about 180-400 microns (Fig. 4, 190 fluid conduit comprising 225 openings and 194 lumen; para. 0038). Nissan further discloses that the compliant fluid conduit has an outer diameter of about 600 microns (para. 0038). These teachings together seem to suggest that the thickness of the compliant fluid conduit has a thickness between 100-210 microns (outer diameter of the fluid conduit formed of the diameter of the openings or lumen and the thickness of the compliant fluid conduit on two opposite sides).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of Nissan from between 100-210 microns to between about 100 microns or less 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). Further, applicant appears to have placed no criticality on the claimed range (see para. 00057 indicating that a variety of dimensions are contemplated).
Further, Nissan differs from the instantly claimed invention in that Nissan fails to disclose wherein the first portion of the microstructure has an average pore size of about 20 microns and the material being microporous.
Nissan discloses the luminal wall surface comprising lower porosity than the exterior surface of the compliant fluid conduit and that differences in porosity can be created by differences in size (para. 0047 ln. 8-12; para. 0047 ln. 16-27).
Jacob teaches a fluid conduit comprising an exterior surface comprising a microstructure including a plurality of pores with an average pore size of 15-90 microns (Fig. 3, 12 porous ingrowth surface of 13 conduit; col. 5 ln. 61-67 and col. 6 ln. 1-52).
Jacob is considered to be analogous to the instantly claimed invention in that Jacob discloses a medical device for use in the eye. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the exterior surface of the fluid conduit of Nissan to have pores within the sizes as taught by Jacob, because Jacob teaches that this allows for cellular infiltration and collagen deposition through the pores and around the walls of the pores such that movement of the device is prevented not only from side to side but also perpendicularly to the scleral surface (col. 3 ln. 39-50).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size of the exterior surface of Nissan, as modified by Jacob, from between 15-90 microns to about 20 microns 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). Further, applicant appears to have placed no criticality on the claimed range (see para. 00074 indicating the pore sizes “may” be within the claimed range).
Further still, Nissan differs from the instantly claimed invention in that Nissan fails to explicitly disclose wherein the second portion of the microstructure has an average pore size less than 2 microns.
Nissan discloses the luminal wall surface comprising lower porosity than the exterior surface of the compliant fluid conduit and that differences in porosity can be created by differences in size (para. 0047 ln. 8-12; para. 0047 ln. 16-27). Nissan further discloses that the second portion of the microstructure is configured to resist cellular ingrowth (para. 0047 ln. 8-12; para. 0047 ln. 16-27; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen wall is considered second region).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Nissan to have an average pore size less than 2 microns in the second portion of the microstructure 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 Nissan would not operate differently with the pore sizes and since the second portion of the microstructure is configured to resist cellular ingrowth (para. 0047 ln. 8-12; para. 0047 ln. 16-27; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen wall is considered second region) the device would function appropriately having the claimed average pore size. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the average pore size in portions of the conduit have an average size of less than 1 or 2 microns (specification para. 00054).
Regarding claim 27, the combination of Nissan and Jacob discloses the invention of claim 25, the combination further discloses: wherein the first portion of the microstructure is at least partially positioned on the exterior of the compliant fluid conduit (Nissan: para. 0047 ln. 8-12; para. 0047 ln. 16-27; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen is considered second region) and the second portion of the microstructure is at least partially positioned on the luminal wall surface (Nissan: para. 0047 ln. 8-12; para. 0047 ln. 16-27; para. 0047-0050, 196 exterior surface is considered first region and 194 lumen wall is considered second region).
Regarding claim 28, the combination of Nissan and Jacob discloses the invention of claim 25, the combination further discloses: wherein the compliant fluid conduit is a polymer tube including a plurality of layers (Nissan: para. 0036; para. 0043 ln. 1-3, 192 fluid conduit may comprise 220 second tubular wall substantially encircling the exterior; para. 0044-0046).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nissan and Jacob as applied above, and further in view of US/2009/0227933 A1 to Karageozian.
Regarding claim 13, the combination of Nissan and Jacob discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose a valve configured to regulate a rate of fluid flowing through the compliant fluid conduit.
Karageozian teaches an ocular tube implant (Fig. 1B’, 12A ocular implant) comprising a valve (Fig. 1B’, 23 valve) configured to regulate a rate of fluid flowing through the tube (para. 0029 lines 5-21, may stop or start fluid flow through 24 lumen).
Karageozian is considered to be analogous to the instantly claimed invention in that Karageozian teaches an ocular implant for lowering intraocular pressure. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the fluid conduit of Nissan and Jacob to further comprise a valve as taught by Karageozian, because Karageozian teaches that a valve may prevent backflow in a first direction and may be constructed to open only when the pressure of fluid within the lumen exceeds a predetermined maximum, providing control of intraocular pressure and preventing the drainage of too much fluid from the eye as a result of hypotony (para. 0029 lines 5-21).
Claims 14-15 rejected under 35 U.S.C. 103 as being unpatentable over Nissan, Jacob, and Karageozian as applied above, and further in view of US/2016/0331528 A1 to Parker.
Regarding claims 14-15, the combination of Nissan, Jacob, and Karageozian discloses the invention of claim 13 above; however, the combination differs from the instantly claimed invention in that the prior art fails to disclose (Claim 14) where the valve is formed from partially unbonded helical windings of a material forming the compliant fluid conduit and (Claim 15) where the valve is integral to the compliant fluid conduit such that the valve and compliant fluid conduit form a monolithic unit.
Parker teaches a fluid conduit (Fig. 9A, 410 fluid conduit) comprising (Claim 14) a valve (Fig. 9B-D, leaflets) formed from partially unbonded helical windings of a material (Fig. 1B-C, showing helical deposition of polymeric fibers) forming the fluid conduit (Fig. 2A-6B; para. 0111-0128, method for forming fluid conduit and leaflets through rotation of a mandrel and rotary jet spinner; para. 0142 lines 1-3, 410 fluid conduit formed by the method with respect to Fig. 2A-6B; para. 0147 lines 14-21, leaflets are partially unbonded to the fluid conduit) and (Claim 15) where the valve (Fig. 9B-D, leaflets) is integral to the fluid conduit (410 fluid conduit) such that the valve and fluid conduit form a monolithic unit (para. 0147 lines 1-3 and 14-21; Fig. 9B-D showing monolithic unit of 410 fluid conduit and leaflets).
Parker is considered to be analogous to the instantly claimed invention in that Parker discloses a valved fluid conduit which may be used as an implant in biological tissues and organs. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the compliant fluid conduit and valve of Nissan, Jacob, and Karageozian to be formed from helical windings as taught by Parker, because Parker teaches that forming the conduit by their method provides greater structural integrity (para. 0149 lines 6-8) and a more uniform conduit than materials formed from multiple layers attached to each other at discrete points (para. 0149 lines 9-12) and that forming a valve integrally with the conduit provides greater structural integrity and reliability due to reduction of stress at the connection between the leaflets and the conduit (para. 0148 lines 5-9) and provides a more uniform structure (para. 0148 lines 10-12). Parker further teaches that a more uniform structure promotes tissue ingrowth as opposed to the formation of scar tissue (para. 0148 lines 11-14).
Regarding the limitation “where the valve is configured to regulate a rate of fluid backflowing through the compliant fluid conduit in a direction toward an anterior chamber of the eye”, the combination of Nissan, Jacob, Karageozian, and Parker discloses where the valve (Karageozian: 23 valve; Parker: Fig. 9B-D leaflets) is configured to regulate a rate of fluid backflowing through the compliant fluid conduit (Nissan: 190 fluid conduit) in a direction toward an anterior chamber of the eye (Karageozian: para. 0029 lines 6-9).
Conclusion
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/Linnae E. Raymond/Examiner, Art Unit 3781
/NICHOLAS J. WEISS/Supervisory Patent Examiner, Art Unit 3781