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 .
Response to Amendment
Applicant amended claims 1, 5, 9-11, and 19. Claims 1-26 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 9-15 of Applicant’s Remarks, filed 07/06/26, with respect to the rejections of claims 1-8, 11-14, 17-18, 19-22, and 25-26 under 35 U.S.C. 103 as unpatentable over Heitzmann in view of Nissan, of claims 9-10 as unpatentable over Mixter in view of Nissan, and of claims 23-24 as unpatentable over Heitzmann in view of Nissan and in further view of Chu have been fully considered and are persuasive in light of the amendments to the independent claims to require, among other things, that the compliant material is configured to direct fluid flow from the internal surface to the external surface. Accordingly, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated below.
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 are rejected under 35 U.S.C. 103 as being unpatentable over Silvestrini (US 2012/0310137 A1) in view of Nissan et al. (US 2013/0325024 A1).
Regarding claims 1 and 5, Silvestrini discloses a suprachoroidal implantable device (Figs. 1-3A, feat. 100; Fig. 3B, feat. 200; ¶0025, 0041, 0052-0057) comprising: a body portion (Fig. 3B, feat. 200; ¶0057) formed of a compliant material (230; ¶0026-0029, 0036, and 0101-0104) having an external surface and an internal surface (Fig. 3B) defining an internal reservoir of the body portion with a fixed volume (214; ¶0057), the body portion having a porosity (¶0026-0029 and 0057) with a first porosity located proximate the external surface (¶0029) with respect to claim 1 or the external surface having a first porosity (¶0029) with respect to claim 5, wherein the first porosity facilitates tissue ingrowth at the external surface (¶0029), and wherein the compliant material is configured to direct fluid flow from the internal surface to the external surface in response to fluid pressure within the internal reservoir to reduce intraocular pressure within an eye in which the device is implanted (Fig. 3B, feats. 211, 213, 214; ¶0034-0035 and 0057: Proximal opening 211 is open to ingress of aqueous humor from the anterior chamber and is in fluid communication with reservoir/lumen 214. Distal opening 213 is covered by a porous, permeable layer 230. High fluid pressure in the anterior chamber will lead to a high fluid pressure in the reservoir/lumen 214 and cause fluid to escape from the interior to the exterior of the porous permeable layer 230 covering distal opening 213.).
With respect to claim 1, Silvestrini does not disclose that the body portion has a variable porosity, that the porosity transitions from the first porosity to a second porosity less than the first porosity and located proximate the internal surface, or that the second porosity inhibits tissue ingrowth through the internal surface. With respect to claim 5, Silvestrini does not disclose that the internal surface has a second porosity less than the first porosity or that the second porosity inhibits tissue ingrowth through the internal surface.
Nissan teaches an ocular implant (Figs. 3-6, feat. 180; ¶0027) comprising a tubular body (190; ¶0033-0035) with an external surface (196) and an internal surface (194). Nissan further teaches that the tubular body comprises pores which forma porosity gradient such that a second porosity at the internal surface is smaller than a first porosity at the external surface (Figs. 7-9; ¶0046-0050). This facilitates tissue ingrowth through the external surface, but preventing it through the internal surface in order to stabilize the implant in its location while ensuring the suitable conveyance of fluid through the lumen or reservoir (¶0046-0047). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Silvestrini so that the body portion has a variable porosity, that the porosity transitions from the first porosity to a second porosity less than the first porosity and located proximate the internal surface, and that the second porosity inhibits tissue ingrowth through the internal surface, with respect to claim 1, or so that the internal surface has a second porosity less than the first porosity and that the second porosity inhibits tissue ingrowth through the internal surface, with respect to claim 5, in order to stabilize the implant in its location while ensuring the suitable conveyance of fluid through the lumen or reservoir as taught by Nissan.
Regarding claims 2 and 6, Silvestrini in view of Nissan suggests the devices of claims 1 and 5, respectively. Nissan further teaches that the porosity gradient can be created by varying the size of the pores (¶0047 and 0053), and therefore that the second average pore size may be smaller than the first average pore size. Therefore, Heitzmann in view of Nissan further suggests that the first porosity is defined by a first average pore size, and the second porosity is defined by a second average pore size that is smaller than the first average pore size.
Regarding claims 3 and 7, Silvestrini in view of Nissan suggests the devices of claims 1 and 5, respectively. Nissan further teaches that the porosity is selected to enable tissue ingrowth to secure the device (¶0046-0047 and 0053). Therefore, Silvestrini in view of Nissan further suggests that the external surface is a tissue engagement surface, the tissue engagement surface has a porosity extending into the engagement surface at an engagement depth to which an external tissue engages in order to secure or anchor the body portion at a suprachoroidal location in an eye at which the device is implanted.
Nissan is silent with respect to the porosity being selected such that the external tissue is observable to engage the engagement surface at the engagement depth after 30 days. However, as discussed above, the device suggested by Silvestrini in view of Nissan has the same structure as the claimed devices and, because it is secured in place by tissue ingrowth into the porosity of the external surface, functions in the same way as the claimed devices. The Federal Circuit 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. Please see MPEP §2144.04(IV)(A) with respect to Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In this case, because the devices suggested by Silvestrini in view of Nissan is secured in place by tissue ingrowth into the porosity of the external surface, they would not perform differently than the claimed device if the porosity was selected such that the external tissue is observable to engage the engagement surface at the engagement depth after 30 days as claimed, and therefore the claimed devices are not patentably distinct from the devices suggested by Silvestrini in view of Nissan.
Regarding claims 4 and 8, Silvestrini in view of Nissan suggests the devices of claims 1 and 5, respectively. Silvestrini further discloses that one or both of the outer surface and the inner surface of the device, and therefore the reservoir, may comprise a resorbable polymer with a drug or medicament which is released through the porous body into the implant site (¶0027 and 0106). Therefore, Silvestrini in view of Nissan further suggests that the internal reservoir includes a filler material encapsulated therein, and the filter material includes a medicament selected to pass through the compliant material from the internal surface to the external surface.
Silvestrini is silent with respect to the medicament being released over a period of 30 days. However, as discussed above, the devices suggested by Silvestrini in view of Nissan have the same structure as the claimed devices and function in the same way as the claimed devices. The Federal Circuit 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. Please see MPEP §2144.04(IV)(A) with respect to Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In this case, because the devices suggested by Silvestrini in view of Nissan have the same structure as the claimed devices and comprise an encapsulated filler material with a medicament which is released through the porous, compliant material, they would not perform differently than the claimed devices if the medicament was selected to be released over a period of 30 days as claimed, and therefore the claimed devices are not patentably distinct from the devices suggested by Silvestrini in view of Nissan.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Silvestrini in view of Nissan and in further view of Mixter et al. (US 2020/0229981 A1).
Regarding claims 9-10, Silvestrini discloses a suprachoroidal implantable device (Figs. 1-3A, feat. 100; Fig. 3B, feat. 200; ¶0025, 0041, 0052-0057) comprising: a body portion (Fig. 3B, feat. 200; ¶0057) formed of a compliant material (230; ¶0026-0029, 0036, and 0101-0104) having an external surface and an internal surface (Fig. 3B) defining an internal reservoir of the body portion with an internal volume (214; ¶0057), the body portion having a porosity (¶0026-0029 and 0057) with a first porosity located proximate the external surface (¶0029) with respect to claim 9 or the external surface having a first porosity (¶0029) with respect to claim 10, wherein the first porosity facilitates tissue ingrowth at the external surface (¶0029), and wherein the compliant material is configured to direct fluid flow from the internal surface to the external surface in response to fluid pressure within the internal reservoir to reduce intraocular pressure within an eye in which the device is implanted (Fig. 3B, feats. 211, 213, 214; ¶0034-0035 and 0057: Proximal opening 211 is open to ingress of aqueous humor from the anterior chamber and is in fluid communication with reservoir/lumen 214. Distal opening 213 is covered by a porous, permeable layer 230. High fluid pressure in the anterior chamber will lead to a high fluid pressure in the reservoir/lumen 214 and cause fluid to escape from the interior to the exterior of the porous permeable layer 230 covering distal opening 213.).
With respect to claim 9, Silvestrini does not disclose that the body portion has a variable porosity, that the porosity transitions from the first porosity to a second porosity less than the first porosity and located proximate the internal surface, or that the second porosity inhibits tissue ingrowth through the internal surface. With respect to claim 10, Silvestrini does not disclose that the internal surface has a second porosity less than the first porosity or that the second porosity inhibits tissue ingrowth through the internal surface. With respect to both claims 9 and 10, Silvestrini does not disclose that the internal volume of the reservoir is adjustable in situ.
Nissan teaches an ocular implant (Figs. 3-6, feat. 180; ¶0027) comprising a tubular body (190; ¶0033-0035) with an external surface (196) and an internal surface (194). Nissan further teaches that the tubular body comprises pores which forma porosity gradient such that a second porosity at the internal surface is smaller than a first porosity at the external surface (Figs. 7-9; ¶0046-0050). This facilitates tissue ingrowth through the external surface, but preventing it through the internal surface in order to stabilize the implant in its location while ensuring the suitable conveyance of fluid through the lumen or reservoir (¶0046-0047). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Silvestrini so that the body portion has a variable porosity, that the porosity transitions from the first porosity to a second porosity less than the first porosity and located proximate the internal surface, and that the second porosity inhibits tissue ingrowth through the internal surface, with respect to claim 9, or so that the internal surface has a second porosity less than the first porosity and that the second porosity inhibits tissue ingrowth through the internal surface, with respect to claim 10, in order to stabilize the implant in its location while ensuring the suitable conveyance of fluid through the lumen or reservoir as taught by Nissan.
Silvestrini in view of Nissan does not suggest that the internal volume of the reservoir is adjustable in situ.
Mixter teaches a suprachoroidal implantable device (Figs. 3A-C, feat. 300; ¶0034-0040, 0048, and 0071) comprising a body portion (327) formed of a compliant material (¶0035) which may further include a flow-through lumen or reservoir (Figs. 13E-F, feat. 1316; ¶0048 and 0071) and a control lumen or reservoir adjacent to it (Figs. 13E-F, feat. 1336; ¶0071). Fluid may be injected or removed from the control lumen or reservoir (1336) using a syringe to increase or decrease its volume, which respectively decreases or increases the cross-sectional area, and therefore volume, of the flow-through lumen (1316), which advantageously changes the fluid resistance of the flow-through lumen and flow rate through it (¶0071). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the devices suggested by Silvestrini in view of Nissan so that they include an adjustable control lumen or reservoir adjacent the internal reservoir which can have fluid injected or removed from it using a syringe as taught by Mixter so that the internal volume of the internal reservoir is adjustable in situ in order to allow flow through the internal reservoir to be adjusted as taught by Mixter.
Claims 11-14, 17-22, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Silvestrini in view of Nissan and in further view of De Juan et al. (US 2018/0092775 A1).
Regarding claims 11 and 19, Silvestrini discloses a suprachoroidal implantable device (Figs. 1-3A, feat. 100; Fig. 3B, feat. 200; ¶0025, 0041, 0052-0057) comprising: a body portion (Fig. 3B, feat. 200; ¶0057) having a closed end (Fig. 3B, feat. 213) and an open end fluidly couplable with an anterior chamber (AC) of an eye to receive aqueous humor from the AC under intraocular pressure (Fig. 3B, feat. 211; ¶0057), the body portion comprising a first surface and a second surface (Fig. 3B), the body portion having a porosity (¶0026-0029 and 0057) with a first porosity proximate the first surface (¶0029) with respect to claim 11 or the first surface having a first porosity (¶0029) with respect to claim 19, wherein the first porosity facilitates tissue ingrowth at the first surface (¶0029) and wherein the body portion is configured to direct the aqueous humor received from the AC through the body portion from the second surface to the first surface in response to the intraocular pressure to reduce intraocular pressure within the eye (Fig. 3B, feats. 211, 213, 214; ¶0034-0035 and 0057: Proximal opening 211 is open to ingress of aqueous humor from the anterior chamber and is in fluid communication with reservoir/lumen 214. Distal opening 213 is covered by a porous, permeable layer 230. High fluid pressure in the anterior chamber will lead to a high fluid pressure in the reservoir/lumen 214 and cause fluid to escape from the interior to the exterior of the porous permeable layer 230 covering distal opening 213.).
With respect to claim 11, Silvestrini does not disclose that the body portion has a variable porosity, that the porosity transitions from the first porosity to a second porosity less than the first porosity and located proximate the second surface, or that the second porosity inhibits tissue ingrowth through the second surface. With respect to claim 19, Silvestrini does not disclose that the second surface having a second porosity less than the first porosity or that the second porosity inhibits tissue ingrowth through the second surface. With respect to both claims 11 and 19, Silvestrini does not disclose that the body portion is configured to exert outward forces on tissue surrounding the body portion when implanted in a suprachoroidal space to maintain the suprachoroidal space as a secondary drainage pathway for aqueous humor from the AC.
Nissan teaches an ocular implant (Figs. 3-6, feat. 180; ¶0027) comprising a tubular body (190; ¶0033-0035) with an external surface (196) and an internal surface (194). Nissan further teaches that the tubular body comprises pores which forma porosity gradient such that a second porosity at the internal surface is smaller than a first porosity at the external surface (Figs. 7-9; ¶0046-0050). This facilitates tissue ingrowth through the external surface, but preventing it through the internal surface in order to stabilize the implant in its location while ensuring the suitable conveyance of fluid through the lumen or reservoir (¶0046-0047). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Silvestrini so that the body portion has a variable porosity, that the porosity transitions from the first porosity to a second porosity less than the first porosity and located proximate the second surface, and that the second porosity inhibits tissue ingrowth through the second surface, with respect to claim 11, or so that the second surface has a second porosity less than the first porosity and that the second porosity inhibits tissue ingrowth through the internal surface, with respect to claim 19, in order to stabilize the implant in its location while ensuring the suitable conveyance of fluid through the lumen or reservoir as taught by Nissan.
Silvestrini in view of Nissan does not suggest that the body portion is configured to exert outward forces on tissue surrounding the body portion when implanted in a suprachoroidal space to maintain the suprachoroidal space as a secondary drainage pathway for aqueous humor from the AC.
De Juan teaches glaucoma treatment devices (Fig. 1 and 44-47, feat. 105; ¶0085 and 0191-0193) comprising a shunt which drains aqueous humor from the anterior chamber into the suprachoroidal space (¶0085). De Juan teaches that the shunt may be configured to exert force on the suprachoroidal space to form a space or lake for the accumulation of drained aqueous humor, which advantageously reduces the risk of infection or other complications due to being enclosed by the tissue of the suprachoroidal space (¶0193). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the devices suggested by Silvestrini in view of Nissan so that the body portion is configured to exert outward forces on tissue surrounding the body portion when implanted in a suprachoroidal space to maintain the suprachoroidal space as a secondary drainage pathway for aqueous humor from the AC in order to reduce intraocular pressure while reducing the risk of infection or other complications as taught by De Juan.
Regarding claims 12 and 20, Silvestrini in view of Nissan and in further view of De Juan suggests the devices of claims 11 and 19, respectively, and Silvestrini further discloses that the body portion is a tubular construct (¶0025) having a first end (Fig. 3B, feat. 213) and a second end (Fig. 3B, feat. 211), wherein the first end is closed to form the closed end of the body portion (Fig. 3B, feat. 213; ¶0057), and the second end is retained in an open configuration to form the open end of the body portion (Fig. 3B, feat. 211; ¶0057). Regarding claims 13 and 21, Silvestrini further discloses that the body portion has a substantially circular cross-section (¶0025 and 0053). Regarding claims 14 and 22, Silvestrini further discloses that the body portion has a substantially ovular or rounded rectangular cross-section (¶0025 and 0053).
Regarding claims 17 and 25, Silvestrini in view of Nissan and in further view of De Juan suggests the devices of claims 11 and 19, respectively. Nissan further teaches that the body portion may comprise multiple porous layers with different porosities (Fig. 5, feats. 205, 210, and 215; ¶0039-0040). One of the layers, such as the innermost layer may be made of an elastic material such as a fluoroelastomer (¶0036 and 0039-0040), and would therefore be an elastic support structure. Therefore Silvestrini in view of Nissan and in further view of De Juan further suggests that the body portion includes: an external microporous layer, and an internal elastic support structure disposed within the external microporous layer and defining an internal space, wherein the external microporous layer defines both the first surface and the second surface, and wherein the internal elastic support structure has a third porosity.
Regarding claims 18 and 26, Silvestrini in view of Nissan and in further view of De Juan suggests the devices of claims 17 and 25, respectively. Nissan further teaches that the porosity may be maximized near the lumen, or internal space, of the device (¶0047), which is where the innermost elastic support structure is located. Therefore, Silvestrini in view of Nissan and in further view of De Juan further suggests that the third porosity is greater than the first porosity and the second porosity to facilitate fluid communication between the internal space and the second surface.
Claims 15-16 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Silvestrini in view of Nissan, in further view of De Juan, and in further view of Chu (US 2019/0298572 A1).
Regarding claims 15 and 23, Silvestrini in view of Nissan and in further view of De Juan suggests the devices of claims 14 and 22, respectively. Silvestrini in view of Nissan and in further view of De Juan does not disclose that in an absence of external forces, the body portion assumes a first configuration that has a first height and a first width, and in response to external forces being applied to the body portion, the body portion assumes a second configuration that has a second height and a second width, wherein the second height is less than the first height, and the second width is greater than the first width. Regarding claims 16 and 24, Silvestrini in view of Nissan and in further view of De Juan are further silent with respect to the body portion reversibly transitioning between the first configuration and the second configuration in the presence or absence of the external forces being applied to the body portion.
Chu teaches an ocular implant (Figs. 2-5, feat. 115) comprising a conduit (130) which may have a circular, ovular, or rectangular shape (¶0143). Under the application of external forces, the conduit may collapse from a first configuration (Fig. 4) to a second configuration with a smaller height, but larger width than in the first configuration (Fig. 5) while remaining open, which advantageously allows continuous flow with minimum irritation (¶0143). The conduit may be made of a resilient material such that it regains its original shape when the force is removed (¶0026-0027). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the devices suggested by Silvestrini in view of Nissan and in further view of De Juan so that in an absence of external forces, the body portion assumes a first configuration that has a first height and a first width, and in response to external forces being applied to the body portion, the body portion assumes a second configuration that has a second height and a second width, wherein the second height is less than the first height, and the second width is greater than the first width, with respect to claims 15 and 23, and so that the body portion reversibly transitioning between the first configuration and the second configuration in the presence or absence of the external forces being applied to the body portion, with respect to claims 16 and 24, as taught by Chu so that the device allows continuous flow with minimum irritation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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