DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 19 December 2025 has been entered.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-9, 14, 18-20, 23, 24 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kahook; Malik et al. (US 20130267887 A1) in view of Simon, Gabriel (US 20040254521 A1).
Regarding claim 1, Kahook discloses a micro invasive glaucoma surgery (MIGS) microstent (¶ [0003], stent or shunt devices for the treatment of glaucoma; ¶ [0011], [0034], [0097] FIG. 3A shows an exemplary implementation of a shunt 100'; ¶ [0106] FIG. 6 depicts a further exemplary embodiment of a SMP shunt 300);
comprising: a MIGS microstent with proximal and distal ends (¶ [0098] The shunt 100 may be sized longitudinally to span the distance between the anterior chamber and the scleral surface at the limbus 20 … the shunt 100 may have an outside diameter between about 50 and 800 microns in a deployed configuration);
the MIGS microstent having therein at least one channel that extends between the proximal and distal ends (¶ [0106] FIG. 6 … The various lumens 310 can be grouped together (as shown) or separated throughout the body of the shunt 300);
the MIGS microstent further having therein at least one sealed channel that extends between the proximal and distal ends, the at least one sealed channel having an opening at the distal end and a seal at the proximal end to prevent fluid flow therethrough (¶ [0106], By providing a plurality of lumen 310, the shunt 300 can be titrated by slowly opening one or more lumen with an external activation source (e.g., a laser). The lumens 310 may initially be plugged or collapsed and then selectively unplugged or expanded through external activation).
Kahook does not explicitly disclose whether the MIGS microstent has an open channel or whether the seal is a thin membrane. Simon discloses surgical treatments and methods for glaucoma comprising a microstent (¶ [0002], [0012], [0054], a thin planar shunt device that can have various shapes and configurations as depicted in FIGS. 1 through 6);
comprising: a MIGS microstent with proximal and distal ends (¶ [0055] Referring to FIG. 1, one embodiment of a shunt device 100A comprises a thin planar body 102; ¶ [0078] FIG. 19 is a schematic view of an alternative shunt 200);
the MIGS microstent having therein at least one open channel (¶ [0078], The shunt 200 again has a microchannel array 210 with inflow ports 212A about the edge of open region 215A);
the at least one open channel having openings at both its ends to allow fluid flow therethrough (¶ [0078], In one embodiment, the shunt may carry from 25 to 100 microchannels with about one-half having being in a closed-end condition in its pre-deployed state);
the MIGS microstent further having therein at least one sealed channel that extends between the proximal and distal ends, the at least one sealed channel having an opening at the distal end and a seal at the proximal end to prevent fluid flow therethrough (¶ [0078], In this embodiment, that microchannel array 210 comprises at least one channel terminating in inflow port 212A that has a "closed-end" condition when the shunt is implanted. The closed-end of the selected microchannels 222 are illustrated in FIG. 19);
wherein the seal is a thin membrane (¶ [0079], The photo-ablation of the closed-end channel can be accomplished with an excimer laser through an incision, for example as in FIGS. 9 and 10 … the closed-end channel 222 can simply comprise a thin wall portion of the shunt body … that is located over the inflow end 212A of the channel 210. For example, a shunt of gold can have a thin perforatable layer over the end of the microchannel 210 that can be opened with the excimer irradiation).
Simon demonstrates how to selectively seal and later open a plurality of channels through a microstent. One would be motivated to modify Kahook with Simon’s open channel and thin membrane seal since Kahook calls for sealing and later unsealing channels with a laser but does not depict the channels’ cross-sections or their seals (¶ [0106]). Therefore, it would have been obvious to modify Kahook with Simon’s open channel and thin membrane seal in order to construct an array of variably sealed lumens.
Regarding claims 2-9, Kahook discloses a microstent comprising multiple channels (¶ [0106] FIG. 6 depicts a further exemplary embodiment of a SMP shunt 300 that defines a plurality of lumens 310 extending therethrough). Kahook does not explicitly count the number of sealed and open channels. Simon discloses a MIGS microstent and counts its number of channels (¶ [0019], An even further embodiment provides such a system wherein the at least one microchannel comprises between 10 and 100 microchannels; ¶ [0065], The number of microchannels 110 in the shunt body typically can range from one to a hundred or more).
Simon’s channel count overlaps the claimed ranges of 2 to 7, 2 to 5, 2 to 3 or 2 sealed channels and one open channel. In Fig. 19A, Simon explicitly depicts two sealed channels and one open channel (two channels have a closed end 222 and one channel remains open at 212A).
Simon selects a suitable range of channels for draining aqueous humor and progressively lowering the shunt’s resistance. A skilled artisan would have been able to modify Kahook with Simon’s channel count by constructing Kahook’s implant with a number of channels in Simon’s range. Therefore, it would have been obvious to modify Kahook with Simon’s channel count in order to adequately relieve an elevated IOP with sufficient channels.
Regarding claims 14, 18-20, 24 and 30, Kahook discloses a glaucoma MIGS microstent wherein the channels are parallel (¶ [0106] FIG. 6 … The various lumens 310 can be grouped together (as shown) or separated throughout the body of the shunt 300; claim 8, wherein the lumen further comprises a plurality of substantially parallel lumen);
wherein the MIGS stent is formed from a polymer (¶ [0034], the shunt is formed of a shape memory polymer material; ¶ [0048] In one embodiment, the copolymer network consists of two acrylate-based monomers; ¶ [0049], The SMP material may be photopolymerized from several different monomers and/or homopolymers to achieve a range of desired thermomechanical properties; ¶ [0052] Synthetically modified natural polymers include cellulose derivatives … These are collectively referred to herein as "celluloses");
wherein the polymer is selected from the group consisting of silicone, cross-linked polyvinyl alcohol (PVA) hydrogel, cross-linked PVA hydrogel foam, polyurethane, polyamide, styrene isobutylene-styrene block copolymer (Kraton), polyethylene terephthalate, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, and polytetrafluoroethylene (¶ [0051] Representative synthetic polymer blocks or polymers include polyphosphazenes, poly(vinyl alcohols), polyamides, polyester amides, poly(amino acid)s, synthetic poly(amino acids), polyanhydrides, polycarbonates, polyacrylates, polyalkylenes, polyacrylamides, polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates, polyortho esters, polyvinyl ethers, polyvinyl esters, polyvinyl halides, polyvinylpyrrolidone, polyesters, polylactides, polyglycolides, polysiloxanes, polyurethanes and copolymers thereof; ¶ [0054], poly(meth)acrylic acid, polyamides, polyethylene, polypropylene, polystyrene);
wherein the MIGS stent is formed from a gel material (¶ [0050] Representative natural polymer blocks or polymers include proteins such as zein, modified zein, casein, gelatin, gluten, serum albumin, and collagen, and polysaccharides such as alginate, celluloses, dextrans, pullulane, and polyhyaluronic acid, … Representative natural biodegradable polymer blocks or polymers include polysaccharides such as alginate, dextran, cellulose; ¶ [0052] Synthetically modified natural polymers include cellulose derivatives …These are collectively referred to herein as "celluloses");
a method of treating glaucoma in a subject in need thereof comprising: inserting a MIGS microstent of claim 1 into the eye of a subject so that the proximal end of the microstent is located in the anterior chamber of the eye and the distal end is located in a portion of eye allowing drainage into the subconjunctival space of the eye (¶ [0077], One methodology … to implant a shunt device through the sclera 16, through Schlemm's canal 32, and through the trabecular meshwork 30 directly into the anterior chamber angle 28 in order to transport aqueous humor directly from the anterior chamber 22 to a pocket between the conjunctiva 18 and the sclera 16);
so that intraocular pressure in the anterior chamber is reduced due to the flow of fluid through the open channel of the MIGS microstent (¶ [0077], The shunt may augment or bypass the natural physiological outflow pathways … to help balance the intraocular pressure); and
a deployment device comprising a MIGS microstent according to claim 1 inserted into a hollow shaft having a proximal end and a distal end (¶ [0113] FIGS. 8A-8F depict an exemplary procedure for implantation of the shunt 400 at a location 40 adjacent the limbus 20 through the sclera 16 and into the anterior chamber 22; ¶ [0114] The shunt 400' in a compressed, predeployed configuration my be placed within the lumen of the needle 52 before the needle is advanced through the sclera 16).
Regarding claim 23, Kahook discloses a MIGS microstent comprising a material selected from the group consisting of silicone, polyurethane, polyamide, styrene isobutylene-styrene block copolymer (Kraton), polyethylene terephthalate, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, and polytetrafluoroethylene (¶ [0051] Representative synthetic polymer blocks or polymers include polyphosphazenes, poly(vinyl alcohols), polyamides, polyester amides, poly(amino acid)s, synthetic poly(amino acids), polyanhydrides, polycarbonates, polyacrylates, polyalkylenes, polyacrylamides, polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates, polyortho esters, polyvinyl ethers, polyvinyl esters, polyvinyl halides, polyvinylpyrrolidone, polyesters, polylactides, polyglycolides, polysiloxanes, polyurethanes and copolymers thereof; ¶ [0054], poly(meth)acrylic acid, polyamides, polyethylene, polypropylene, polystyrene).
Kahook does not explicitly disclose that the membrane comprises the same materials as the stent’s body. Simon discloses a MIGS microstent wherein the membrane comprises the same materials as the stent’s body (¶ [0079], In one shunt embodiment, the closed-end channel 222 can simply comprise a thin wall portion of the shunt body).
A skilled artisan would have been able to modify Kahook with Simon’s seals by constructing the seals from the same materials as the wall, according to Simon’s example. Regarding the rationale and motivation to modify Kahook with Simon’s multiple seals, see the discussion of claim 1 above.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable Kahook and Simon in view of Bouremel; Yann et al. (US 20210161713 A1, GB 201805439 D0).
Regarding claim 10, Kahook and Simon are silent regarding the channels’ flow resistance. Bouremel discloses a drainage device for treating glaucoma comprising a microstent (¶ [0009], [0018], [0085] As shown in FIG. 2, the GDD 7 is a triple-lumen tube having a first end 11 and a second end 12 opposite the first end);
having multiple channels (¶ [0085], FIG. 3 is an ‘X-ray’ type image showing three lumens 13, 14, 15 extending from the first end to the second end);
wherein each of the channels are sized to provide a pressure difference of from 0.5 to 8.0 mm Hg across the channels (¶ [0103] Table 1 shows the resistance of the device as well as the pressure drop (at 2 μl/min) for locations lasered 1 mm apart along each lumen). In Table 1, Bouremel shows that the channels’ resistance can be altered by selectively lasering an aperture, which produces a pressure drop between 0.2-4.6 mm Hg at 2 µl / min.
Bouremel demonstrates how to finely adjust the flow resistance or pressure drop through a channel in a microstent (¶ [0104], Positions 1, 2, 3, and 4 are hypothetical locations, but any locations in between each of the positions are also possible giving an infinite control of the resistance of the GDD 7 and hence the IOP of the patient). One would be motivated to modify Kahook and Simon with Bouremel’s flow resistance range to regulate IOP within an acceptable range. For example, Simon calls for regulating IOP within a specific numeric range (¶ [0066] In one embodiment the shunt is intended for a target IOP in the range of 8-16 mmHg). Therefore, it would have been obvious to modify Kahook and Simon with Bouremel’s flow resistance values in order to accurately regulate a patient’s IOP.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kahook and Simon in view of Bene, Eric A. et al. (US 20050119737 A1).
Regarding claim 17, Kahook and Simon lack a rim portion. Bene discloses an ocular implant device comprising a microstent (¶ [0002], [0011], [0032] FIG. 1 shows the shunt 10);
having plural channels (¶ [0042] The filter can also be constructed as a flow restrictor, such as a glass capillary flow restrictor 132 as shown in FIG. 5 which includes multiple through holes that are used to effectively control flow between the distal and proximal ends of the opening 134 in the shunt 130; ¶ [0082] As shown in FIGS. 38 and 39, another hollow or capillary action micro-device can consist of two or more separate parts 372 and 374, which are bonded together … a maze of capillary vessels 376 are implanted or imbedded);
wherein the proximal end of the stent comprises a rim portion that extends past the terminal ends of the channels (¶ [0083] In another variation of the capillary member shown in FIG. 42, the capillary vessels of member 378 have a straight profile where extending through the reservoir section. However, near opposite ends, the capillary vessels can be reduced in diameter, or constructed having an enlarged conical orifice at one or both ends, thereby controlling resistance at the device).
Bene regulates flow resistance through a plurality of channels by altering the shape of their proximal or distal ends. A skilled artisan would have been able to modify Kahook and Simon with Bene’s rim portion by altering the shape of Kahook’s channels according to Bene’s example. One would be motivated to modify Kahook and Simon with Bene’s rim portion since Simon calls for regulating IOP within a specific numeric range (¶ [0066]). Therefore, it would have been obvious to modify Kahook and Simon with Bene’s rim portion in order to adjust or configure the channels’ flow resistance with another technique.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kahook and Simon in view of Yu; Dao-Yi et al. (US 20080108933 A1).
Regarding claim 21, Kahook and Simon lack cross-linked gelatin. Yu discloses methods and apparatus for treating glaucoma (¶ [0002], [0049] FIG. 1 … apparatus 10; ¶ [0051], FIG. 2 … needle assembly 20);
comprising a microstent having a channel (¶ [0049] FIG. 1 … microfistula tube 26; ¶ [0103] Channels 26 useful in the present invention, are preferably made of a biocompatible and preferably bioabsorbable material; ¶ [0107] Channels used in the present invention are generally cylindrically shaped having an outside cylindrical wall and, in one embodiment, a hollow interior);
wherein the stent is formed from a gel material, wherein the gel material is a cross-linked gelatin (¶ [0104], the material selected for the channels is preferably a gelatin or other similar material … gelatin Type B from bovine skin; ¶ [0105], gelatin channels are preferably cross-linked … the formed gelatin channels are treated with a solution of a cross-linking agent such as, but not limited to, glutaraldehyde … 1-ethyl-3-[3-(dimethyamino)propyl]carbodiimide (EDC). Cross-linking by radiation, such as gamma or electron beam (e-beam) may be alternatively employed).
Yu enables a microstent to dissolve over time and also regulates the microstent’s degradation rate by adjusting the degree of cross-linking (¶ [0048], Microfistula tube 26 remains implanted in the eye, and eventually dissolves; ¶ [0105] Cross-linking increases the inter-and intramolecular binding of the gelatin substrate; ¶ [0113], In general, the more cross-linking, the longer the survival of the channel in the body). One would be motivated to modify Kahook and Simon with Yu’s cross-linked gelatin to adjust how long it persists or remains in the patient’s body before dissolving. Kahook also calls for related degradable polymers (¶ [0050] Representative natural polymer blocks or polymers include proteins such as zein, modified zein, casein, gelatin, gluten, serum albumin, and collagen, and polysaccharides). Therefore, it would have been obvious to modify Kahook and Simon with Yu’s cross-linked gelatin in order to enable the microstent to gradually dissolve, and to control how long it remains in the patient’s body.
Response to Arguments
Applicant’s arguments filed 19 December 2025 regarding the rejection of claims 1-10, 14, 17-21, 23-24 and 30 as amended, under 35 USC § 103 over Roeber, Bouremel, Bene and Yu, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Kahook, Bouremel, Simon, Bene and Yu (see above).
Applicant’s arguments regarding Roeber have been considered but are moot because the reference is no longer cited in the current rejection.
Applicant submits that in contrast, Roeber et al. describes a conventional glaucoma treatment device where a fluid conduit (1500) is linked to the reservoir of the aqueous humor diffusion member 1002. Thus, the claims MIGS stent is fundamentally different in structure and purpose from the fluid conduit of Roeber et al. (remarks p. 7). Second, Applicant respectfully reasserts that the Roeber et al. does not teach the claim element of a thin membrane seal (remarks p. 7). Examiner notes that Roeber is not cited in the new grounds of rejection. Kahook and Simon are cited as teaching all features of amended claim 1. Kahook explicitly discloses a tubular glaucoma implant with micro-scale dimensions (¶ [0098] The shunt 100 may be sized longitudinally to span the distance between the anterior chamber and the scleral surface at the limbus 20 … the shunt 100 may have an outside diameter between about 50 and 800 microns in a deployed configuration);
Applicant contends that the other cited references also fail to teach or suggest this claim element (remarks p. 11). Examiner replies that Simon explicitly discloses a membrane seal (¶ [0079], the closed-end channel 222 can simply comprise a thin wall portion of the shunt body … For example, a shunt of gold can have a thin perforatable layer over the end of the microchannel 210 that can be opened with the excimer irradiation).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Liang, Yuan-Bo et al. CN 105997341 A
Yang, Xun CN 106726124 B
Ren, David H. US 20030236483 A1
Camras; Lucinda US 20170087016 A1
Camras; Lucinda J. et al. US 20190254873 A1
Mixter; Colin et al. US 20200229977 A1
Otaka; Isao US 20200229979 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781