DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/18/2026 has been entered.
Acknowledgment
Claims 2, 6-12, 14-19 are amended and filed on 5/18/2026.
Claims 28-29 are newly added.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 4-15, 17-29 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Silvestrini et al. (US. 20090182421A1) (“Silvestrini”) in view of Clauson et al. (US 20110238075 A1) (“Clauson”).
Re claim 2, Silvestrini discloses a drug delivery ocular implant (Figs. 1-9b, ¶0112, ¶0144, wherein the implant 105 is explained in Fig. 1 and retention as in Fig, 9a), comprising: a flexible implant body (905, ¶0112); a first region of drug release configured to elute a first therapeutic agent (¶0113, ¶0141); and one or more retention protrusions (910a-b) protruding from an outer surface of the flexible implant body (Fig. 9a, ¶0142), the one or more retention protrusions comprising a first configuration when in the delivery device (First state , ¶0141) and a second configuration after implantation in the predetermined portion of the eye (¶0144), the one or more retention protrusions being expanded outward relative to the outer surface of the flexible implant body when in the second configuration (¶0144), and further disclose a second therapeutic agent (¶0113, one or more drugs), but it fails to disclose that the body is configured to be deformed change shape from a delivery configuration in a delivery device to a delivered configuration after implantation in a predetermined portion of an eye, wherein, when in the delivery configuration, the flexible implant body is deformed from a preset shape and a second region of drug release configured to elute a second therapeutic agent.
However, Clauson discloses a drug delivery ocular implant (105, Fig. 1- 7, ¶0044, abstract) comprising: a body is configured to be deformed change shape from a delivery configuration (¶0037, ¶0044) in a delivery device to a delivered configuration after implantation in a predetermined portion of an eye (¶0037, ¶0044), wherein, when in the delivery configuration, the flexible implant body is deformed from a preset shape (shape memory, the final shape is determined and preset shape, ¶0037) and a second region of drug release configured to elute a second therapeutic agent (¶0041 different zones for deliverer one more drug, ¶0053).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the device of Silvestrini so that the body is configured to be deformed change shape from a delivery configuration in a delivery device to a delivered configuration after implantation in a predetermined portion of an eye, wherein, when in the delivery configuration, the flexible implant body is deformed from a preset shape and a second region of drug release configured to elute a second therapeutic agent as taught by Clauson for the purpose of facilitating insertion into the desired anatomical location and treating the desired diseases in many of zone for an adequate desired treating time with desired agent (Clauson, ¶0037, ¶0039, ¶0041).
Re claim 4, Silvestrini discloses wherein the implant is biodegradable (¶0114, ¶0185).
Re claim 5, Silvestrini discloses wherein the implant is non-biodegradable (¶0112 such as Nitinol or metal, ¶0185).
Re claim 6, Silvestrini fails to disclose wherein the first therapeutic agent is one or more of prostaglandins, prostaglandin analogs, alpha-blockers, or beta- blockers.
However, Clauson discloses an eye implantable device (Fig. 1-4b) and wherein the at least one therapeutic agent is one or more of prostaglandins, prostaglandin analogs, alpha-blockers, or beta- blockers (beta blockers, prostaglandin ¶094).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the agent of Silvestrini so that the first therapeutic agent is one or more of prostaglandins, prostaglandin analogs, alpha-blockers, or beta- blockers as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0094).
Re claim 7, Silvestrini fails to disclose wherein the first therapeutic agent is selected from the group consisting of: latanoprost, travoprost, timolol, and brimonidine.
However, Clauson discloses an eye implantable device (Fig. 1-4b) and wherein the at least one therapeutic agent is one or more of prostaglandins, prostaglandin analogs, alpha-blockers, or beta- blockers, latanoprost, travoprost, timolol, and brimonidine (latanoprost, ¶0094, timolol, ¶0094).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the agent of Silvestrini so that first therapeutic agent is selected from the group consisting of: latanoprost, travoprost, timolol, and brimonidine as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0094).
Re claim 8, Silvestrini fails to disclose wherein the first region of drug release is configured to modulate a release rate of the first therapeutic agent.
However, Clauson discloses an eye implantable device (Fig. 1-7) and wherein the one or more regions of drug release are configured to modulate a release rate of the at least one therapeutic agent (¶0026, ¶0039).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the agent of Silvestrini so that the first region of drug release is configured to modulate a release rate of the first therapeutic agent as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0039, ¶0026).
Re claim 9, Silvestrini fails to disclose wherein the flexible implant body is semi-permeable to the first therapeutic agent.
However, Clauson discloses an eye implantable device (Fig. 1-7) and wherein the flexible implant body is semi-permeable to the at least one therapeutic agent (¶0056, porous membrane or porous surface, ¶0062).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of Silvestrini so that the flexible implant body is semi-permeable to the first therapeutic agent as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0039).
Re claim 10, Silvestrini fails to disclose wherein the outer shell is substantially impermeable to the first therapeutic agent and comprises one or more orifices for elution of the first therapeutic agent.
However, Clauson discloses an eye implantable device (Fig. 1-7) and wherein the flexible implant body is substantially impermeable to the at least one therapeutic agent (¶0052) and comprises one or more orifices for elution of the at least one therapeutic agent (¶0052 or porous surface, ¶0062).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of Silvestrini so that the outer shell is substantially impermeable to the first therapeutic agent and comprises one or more orifices for elution of the first therapeutic agent as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0039, ¶0052).
Re claim 11, Silvestrini fails to disclose wherein the one or more orifices further comprise a material that is semi-permeable to the first therapeutic agent.
However, Clauson discloses an eye implantable device (Fig. 1-7) and wherein the one or more orifices further comprise a material that is semi-permeable to the at least one therapeutic agent (¶0052 porous membrane or porous surface, ¶0062).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of Silvestrini so that he one or more orifices further comprise a material that is semi-permeable to the first therapeutic agent as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0039).
Re claim 12, Silvestrini fails to disclose wherein the flexible implant body has a first thickness and at least a second thickness that is less than the first thickness, thereby forming a region of reduced thickness in the flexible implant body for elution of the first therapeutic agent.
However, Clauson discloses an eye implantable device (Fig. 1-11) and wherein the flexible implant body has a first thickness ( top of 705, Fig.11) and at least a second thickness (thickness of 710, Fig. 11) that is less than the first thickness, thereby forming a region of reduced thickness in the body for elution of the at least one therapeutic agent (Fig.39).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of Silvestrini so that the flexible implant body has a first thickness and at least a second thickness that is less than the first thickness, thereby forming a region of reduced thickness in the flexible implant body for elution of the first therapeutic agent as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0039).
Re claim 13, Silvestrini discloses that the method is comprising: advancing a needle (530, Fig. 5 ) comprising an actuator (535, ¶0126) and containing the drug delivery ocular implant through the corneal tissue of the eye (105, Fig. 1, ¶0012); advancing the needle to a predetermined position within the eye (¶0123); activating the actuator and expelling the drug delivery ocular implant from the needle (Fig. 1, ¶0123), wherein the expulsion results in the drug delivery ocular implant becoming substantially immobilized in the eye (as retention 910a-b will be expanded to secure the device to the eye, Fig. 9a); and withdrawing the needle (¶0123).
Re claim 14, Silvestrini discloses a method of implanting a drug delivery implant (Figs. 1-17, 105 , 905, ¶0149), the method comprising: forming an opening (incision ¶0049, ¶0151) in an eye to access a predetermined portion of the eye (Figs. 8-9, ¶0151, Fig. 1, Fig. 17); advancing a delivery device (Fig. 6a, Fig. 17, 530, ¶0123, ¶0151) associated with the drug delivery implant (105, 905) through the opening comprising a flexible implant body through the opening (105, ¶0142, ¶0151); inserting the flexible implant body into the predetermined portion of the eye (¶0141), expanding outward one or more retention protrusions (910a-b, ¶0141) protruding from an outer surface of the flexible implant body (¶0141, Fig. 9a), the one or more retention protrusions protruding from an outer surface of the flexible implant body (Fig. 9a), the one or more retention protrusions being expanded outward from a first configuration (¶0141, first state) to a second configuration (¶0141, second state), wherein, when in the first configuration, the drug delivery implant is within the delivery device, and wherein, when in the second configuration, the drug delivery implant has been inserted into the predetermined portion of the eye (¶0141); and withdrawing the delivery device from the eye (¶0141, retract the shaft ¶0121), and further discloses that the device has drugs (¶0113), but it fails to specifically disclose the flexible implant body being in a delivery configuration when in the delivery device, wherein, when in the delivery configuration, the flexible implant body is deformed from a preset shape; wherein the drug delivery implant comprises a firs region of drug release configured to elute a first drug and a second region of drug release configured to elute a second drug and wherein, upon insertion into the eye, the drug delivery implant changes shape from the delivery configuration to a delivered configuration.
However, Clauson discloses a drug delivery ocular implant (105, Fig. 1- 7, ¶0044, abstract) comprising: a body is configured to be deformed change shape from a delivery configuration (¶0037, ¶0044) in a delivery device to a delivered configuration after implantation in a predetermined portion of an eye (¶0037, ¶0044), the flexible implant body is deformed from a preset shape (¶0037); wherein the drug delivery implant comprises a firs region of drug release configured to elute a first drug and a second region of drug release configured to elute a second drug (¶0041, drugs with different zones to release same of different drugs ) and wherein, upon insertion into the eye, the drug delivery implant changes shape from the delivery configuration to a delivered configuration (memory shape will return to the final shape, ¶0044); the drug is configured to elute from the drug delivery implant for at least one year (¶0037) to treat an ocular condition or disorder (¶0102).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the method of Silvestrini so that the flexible implant body being in a delivery configuration when in the delivery device, wherein, when in the delivery configuration, the flexible implant body is deformed from a preset shape; wherein the drug delivery implant comprises a firs region of drug release configured to elute a first drug and a second region of drug release configured to elute a second drug and wherein, upon insertion into the eye, the drug delivery implant changes shape from the delivery configuration to a delivered configuration as taught by Clauson for the purpose of facilitating insertion into the desired anatomical location and treating the desired disease for an adequate desired treating time with desired agent (Clauson, ¶0037, ¶0039).
Re claim 15, Silvestrini fails to disclose wherein the first drug elutes from the drug delivery implant so as to achieve a therapeutic effect for a period of at least one year.
However, Clauson discloses a drug delivery ocular implant (Fig. 1- , abstract) and the drug elutes from the drug delivery implant so as to achieve a therapeutic effect for a period of at least one year (¶039).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Silvestrini so that the first drug elutes from the drug delivery implant so as to achieve a therapeutic effect for a period of at least one year as taught by Clauson for the purpose of treating eye disease for an adequate treating time (Clauson, ¶0039).
Re claim 17, Silvestrini fails to disclose eluting the first drug through one or more orifices within an outer shell of the implant.
However, Clauson discloses a drug delivery ocular implant (Fig. 1- 7, abstract) and eluting the drug through one or more orifices within an outer shell of the implant (¶0062).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Silvestrini to elute the first drug through one or more orifices within an outer shell of the implant as taught by Clauson for the purpose of controlling the rate of the drug release over the period of treatment (Clauson, ¶0039).
Re claim 18, Silvestrini fails to disclose wherein the one or more orifices further comprise a material that is semi-permeable to the first drug.
However, Clauson discloses an eye implantable device (Fig. 1-7) and wherein the one or more orifices further comprise a material that is semi-permeable to the at least one therapeutic agent (¶0052 porous membrane or porous surface, ¶0062).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of Silvestrini so that the one or more orifices further comprise a material that is semi-permeable to the first drug as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0039).
Re claim 19, Silvestrini fails to disclose wherein the implant comprises an outer shell having a first thickness and at least a second thickness that is less than the first thickness, thereby forming a region of reduced thickness in the outer shell for elution of the first drug.
However, Clauson discloses an eye implantable device (Fig. 1-11) and wherein the flexible implant body has a first thickness ( top of 705, Fig.11) and at least a second thickness (thickness of 710, Fig. 11) that is less than the first thickness, thereby forming a region of reduced thickness in the body for elution of the at least one therapeutic agent (Fig.39).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of Silvestrini so that the flexible implant body has a first thickness and at least a second thickness that is less than the first thickness, thereby forming a region of reduced thickness in the outer shell for elution of the first drug as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0039).
Re claim 20, Silvestrini discloses wherein at least one of the one or more retention protrusions are configured to expand outward in two dimensions (two opposite radius, Fig. 9a).
Re claim 21, Silvestrini discloses wherein at least one of the one or more retention protrusions are configured to expand outward in three dimensions (two radial dimensions and longitudinal dimension, Figs. 9a).
Re claim 22, Silvestrini discloses wherein the one or more retention protrusions comprise a first dimension (radial dimension) in an unexpanded state (¶0143, when 910 within 915, Fig. 9a) and a second dimension in an expanded state (Fig. 9a), the second dimension being greater than the first dimension (¶0143).
Re claim 23, Silvestrini discloses wherein at least one of the one or more retention protrusions are capable to expand outward to attach transiently to an intraocular target tissue (¶0120).
Re claim 24, Silvestrini discloses wherein at least one of the one or more retention protrusions are configured to expand outward to attach permanently to an intraocular target tissue (¶0120, ¶0143).
Re claim 25, Silvestrini discloses comprising a plurality of retention protrusions, each of the plurality of retention protrusions individually connected to the flexible implant body (Fig. 9a).
Re claim 26, Silvestrini discloses the first drug (¶0113), but it fails to specifically disclose that the drug is configured to elute into an anterior chamber of the eye.
However, Clauson discloses an eye implantable device (Fig. 1-11) and wherein the that drug is configured to elute into an anterior chamber of the eye (¶0006. ¶0051).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of Silvestrini so that the first drug is configured to elute into an anterior chamber of the eye.as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0039).
Re claim 27, Silvestrini fails to wherein, when in the delivered configuration, the flexible implant body assumes the preset shape, the preset shape approximating a shape of the predetermined portion of the eye.
However, Clauson discloses an eye implantable device (Fig. 1-11) and wherein, when in the delivered configuration, the flexible implant body assumes the preset shape, the preset shape approximating a shape of the predetermined portion of the eye (memory shape will return to the final shape, ¶0044).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of Silvestrini so wherein, when in the delivered configuration, the flexible implant body assumes the preset shape, the preset shape approximating a shape of the predetermined portion of the eye as taught by Clauson for the purpose of treating eye disease for an adequate desired treating time with desired agent (Clauson, ¶0039).
Re claim 28, the modified Silvestrini discloses wherein the second therapeutic agent is isolated or stored separately from the first therapeutic agent (Clauson, ¶0053).
Re claim 29, the modified Silvestrini discloses wherein the first therapeutic agent is of the same type as the second therapeutic agent (Clauson, ¶0041, ¶0053).
Response to Arguments
Applicant’s arguments, see remark, filed on 5/18/2026with respect to newly added limitation and the rejection(s) of claim(s) 2 and 14 under 103 using Silvestrini in view of Clauson have been fully considered and are not persuasive. The applicant argues with regards to claims 2, 14 and a second region for eluting a second drug. This is found not persuasive see ¶0041, and ¶0053 of Clauson.
Conclusion
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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