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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph (US 6471689 B1) in view of Nissan (US 20130325024 A1).
Annotated Figure 1:
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Regarding Claim 1, Joseph discloses a method of treating diseases (Col 15 ln 40-60), the method comprising: selecting an implantable delivery device (Fig 3, drug delivery device 12) that includes a first microporous material (Figs 2-3, Annotated Figure 1, Col 7 ln 37-58 combination of ingrowth permitting layer 1 and ingrowth resisting layer 2 that comprise the upper portion of outer membrane 32 and the upper part of inner membrane 30, respectively) that is bonded to a second microporous material (Figs 2-3, Annotated Figure 1, Col 7 ln 37-58 combination of ingrowth permitting layer 4 and ingrowth resisting layer 3 that comprise the lower portion of outer membrane 32 and the lower portion of inner membrane 30) in, the first microporous material having a first microporous layer including a plurality of pores sized to permit tissue ingrowth (Figs 2-3 Annotated Figure 1, Col 7 ln 37-58 ingrowth permitting layer 1) and a second microporous layer including a plurality of pores (Figs 2-3 Annotated Figure 1, Col 7 ln 37-58 ingrowth resisting layer 2 comprises pores), the second microporous material having a third microporous layer including a plurality of pores sized to resist tissue ingrowth (Figs 2-3 Annotated Figure 1, Col 7 ln 37-58 ingrowth resisting layer 3) and a fourth microporous layer including a plurality of pores sized to permit tissue ingrowth (Figs 2-3 Annotated Figure 1, Col 7 ln 37-58 ingrowth permitting layer 4), the second microporous layer being bonded to the third microporous layer to thereby form a reservoir for receiving at least one medicament (Fig 3 Col 7 ln 18-19, reservoir 23 for containing and dispersing drugs), wherein the first and second microporous materials are configured to meter a rate at which the medicament is dispensed from the reservoir when the delivery device is implanted (Fig 3, Col 9 ln 27-43, pore size, thickness, and surface area influence medication diffusion, thus the pore sizes of layers 32 and 30 meter a medicament diffusion rate); filling the reservoir with a medicament for treating one or more diseases (Fig 3 Col 10 ln 5-8 drug is delivered to reservoir 23 through catheter 14); implanting the implantable delivery device at an implantation location (Fig 1 shows device 12 implanted in a body); and allowing the medicament to dispense from the reservoir to one or more treatment sites (Col 3 ln 66-67 the device dispenses drugs within a body).
Joseph is silent whether the second microporous layer permits tissue ingrowth, and whether the method is performed on an eye.
However, Nissan teaches an porous ocular implant, thus from the same field of endeavor, wherein the second microporous layer permits tissue ingrowth (Fig 6 ¶[0040][0046-0047] tubular fiber wall 192 may comprise multiple layers having a porosity gradient, with second layer 210 allowing tissue ingrowth) , and the method is performed on an eye (¶[0009][0011] the device is implanted in an eye) to allow the device to remain in place for a period of days, weeks, months, or years (¶[0046]) and in order to treat glaucoma (¶[0004]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Joseph so that the second microporous layer permits tissue ingrowth, and whether the method is performed on an eye, as taught by Nissan to allow the device to remain in place for a period of days, weeks, months, or years (as motivated by Nissan ¶[0046]) and in order to treat glaucoma (as motivated by Nissan ¶[0004]).
Regarding Claim 2, Joseph is silent whether the implantation location is an anterior reservoir location.
However, Nissan teaches an porous ocular implant, thus from the same field of endeavor, wherein the implantation location is an anterior reservoir location (Fig 2 ¶[0053] 190 is implanted into the anterior chamber) to deliver a drug into the anterior chamber to treat glaucoma (¶[0053]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Joseph so that the implantation location is an anterior reservoir location, as taught by Nissan to deliver a drug into the anterior chamber to treat glaucoma (as motivated by Nissan ¶[0053]).
Regarding Claim 3, Joseph is silent whether the one or more eye diseases includes at least one of glaucoma, keratitis, dry eye, or presbyopia.
However, Nissan teaches an porous ocular implant, thus from the same field of endeavor, wherein the one or more eye diseases is glaucoma (¶[0053] drug can be applied through a portion of the shunt to treat glaucoma) because untreated glaucoma can result in a permanent loss of vision (¶[0004]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Joseph so that the one or more eye diseases includes glaucoma, as taught by Nissan because untreated glaucoma can result in a permanent loss of vision (as motivated by Nissan ¶[0004]).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph (US 6471689 B1) in view of Nissan (US 20130325024 A1), further in view of Campbell (US 20210205130 A1).
Regarding Claim 4, Joseph/Nissan is silent whether wherein when the one or more diseases is glaucoma, the medicament has an API class that includes at least one of prostaglandins, prostaglandin structural analogs, beta blockers, alpha agonist, or carbonic anhydrase inhibitors.
However, Campbell teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is glaucoma (¶[0106]), the medicament has an API class that includes at least one of prostaglandins, prostaglandin structural analogs, beta blockers, alpha agonist, or carbonic anhydrase inhibitors (¶[0111] lists prostaglandins, beta blockers, alpha agonists , carbonic anhydrase inhibitors as possible drugs to be delivered).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan so that when the one or more diseases is glaucoma, the medicament has an API class that includes at least one of prostaglandins, prostaglandin structural analogs, beta blockers, alpha agonists, or carbonic anhydrase inhibitors, because untreated glaucoma can result in loss of vision. One of ordinary skill would recognize that substituting the medicament of Joseph for the ocular medicament of Campbell is a simple substitution of one known fluid medication for another known fluid medication.
Regarding Claim 5, Joseph/Nissan is silent whether wherein when the one or more diseases is keratitis, the medicament has an API class that includes at least one of antibiotics, steroids, or antifungal agents.
However, Campbell teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is keratitis (¶[0106]), the medicament has an API class that includes at least one of antibiotics, steroids, or antifungal agents (¶[0108][0116] list antibiotics, steroids, and antifungal agents as possible drugs to be delivered.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan so that when the one or more diseases is keratitis, the medicament has an API class that includes at least one of antibiotics, steroids, or antifungal agents to ameliorate the inflammatory symptoms of keratitis. One of ordinary skill would recognize that substituting the medicament of Joseph for the ocular medicament of Campbell is a simple substitution of one known fluid medication for another known fluid medication.
Regarding Claim 6, Joseph/Nissan is silent whether wherein when the one or more diseases is glaucoma, the medicament has an API class that includes at least one of prostaglandins, prostaglandin structural analogs, beta blockers, alpha agonist, or carbonic anhydrase inhibitors.
However, Campbell teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is dry eye, the medicament has an API class that includes at least one of prostaglandins, prostaglandin structural analogs, beta blockers, alpha agonist, or carbonic anhydrase inhibitors (¶[0111] lists prostaglandins, beta blockers, alpha agonists , carbonic anhydrase inhibitors as possible drugs to be delivered).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan so that when the one or more diseases is dry eye, the medicament has an API class that includes at least one of prostaglandins, prostaglandin structural analogs, beta blockers, alpha agonists, or carbonic anhydrase inhibitors, to ameliorate the symptoms of dry eye. One of ordinary skill would recognize that substituting the medicament of Joseph for the ocular medicament of Campbell is a simple substitution of one known fluid medication for another known fluid medication.
Claims 7-9, 12-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph (US 6471689 B1) in view of Nissan (US 20130325024 A1), further in view of Nivaggioli (US 20050244465 A1).
Regarding Claim 7, Joseph/Nissan is silent whether when the one or more diseases is presbyopia, the medicament has an API class that includes miotics.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is presbyopia (¶[0095]), the medicament has an API class that includes miotics (¶[0051]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan so that when the one or more diseases is presbyopia, the medicament has an API class that includes miotics, to ameliorate the symptoms of presbyopia. One of ordinary skill would recognize that substituting the medicament of Joseph for the ocular medicament of Nivaggioli is a simple substitution of one known fluid medication for another known fluid medication.
Regarding Claim 8, Joseph/Nissan is silent whether the implantation location is a posterior reservoir location.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein the implantation location is a posterior reservoir location (¶[0037]) in order to treat a posterior ocular condition (¶[0096]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Joseph/Nissan so that the implantation location is a posterior reservoir location, as taught by Nivaggioli in order to treat a posterior ocular condition (as motivated by Nivaggioli ¶[0096]).
Regarding Claim 9, Joseph/Nissan is silent whether the one or more eye diseases includes at least one of macular degeneration, geographic atrophy lesion, macular edema, uveitis, retinitis, keratitis, retinoblastoma, central retinal vein occlusion, or branch retinal vein occlusion.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein the one or more eye diseases includes at least one of macular degeneration, geographic atrophy lesion, macular edema, uveitis, retinitis, keratitis, retinoblastoma, central retinal vein occlusion, or branch retinal vein occlusion (¶[0096]) to prevent or reduce the occurrence of loss of vision (¶[0096]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Joseph/Nissan so that the one or more eye diseases includes at least one of macular degeneration, geographic atrophy lesion, macular edema, uveitis, retinitis, keratitis, retinoblastoma, central retinal vein occlusion, or branch retinal vein occlusion, as taught by Nivaggioli to prevent or reduce the occurrence of loss of vision (as motivated by Nivaggioli ¶[0096]).
Regarding Claim 12, Joseph/Nissan is silent whether when the one or more diseases is uveitis, the medicament has an API class that includes corticosteroid.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is uveitis (¶[0009]), the medicament has an API class that includes corticosteroid (¶[0009]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan so that when the one or more diseases is presbyopia, the medicament has an API class that includes miotics, to ameliorate the symptoms of uveitis. One of ordinary skill would recognize that substituting the medicament of Joseph for the ocular medicament of Nivaggioli is a simple substitution of one known fluid medication for another known fluid medication.
Regarding Claim 13, Joseph/Nissan is silent whether when the one or more diseases is uveitis, the medicament has an API class that includes corticosteroid.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is retinitis (¶[0096]), the medicament has an API class that includes antibiotics or antivirals (¶[0051]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan so that when the one or more diseases is retinitis, the medicament has an API class that includes antibiotics or antivirals, to ameliorate the symptoms of retinitis. One of ordinary skill would recognize that substituting the medicament of Joseph for the ocular medicament of Nivaggioli is a simple substitution of one known fluid medication for another known fluid medication.
Regarding Claim 15, Joseph/Nissan is silent whether when the one or more diseases is central retinal vein occlusion or branch retinal vein occlusion, the medicament has an API class that includes monoclonal antibodies or steroids.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is central retinal vein occlusion or branch retinal vein occlusion (¶[0096]), the medicament has an API class that includes monoclonal antibodies or steroids (¶[0052-0053]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan so that when the one or more diseases is central retinal vein occlusion or branch retinal vein occlusion, the medicament has an API class that includes monoclonal antibodies or steroids, to ameliorate the symptoms of central retinal vein occlusion or branch retinal vein occlusion. One of ordinary skill would recognize that substituting the medicament of Joseph for the ocular medicament of Nivaggioli is a simple substitution of one known fluid medication for another known fluid medication.
Regarding Claim 16, Joseph/Nissan is silent whether the implantation location is an anterior-posterior reservoir location.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein the implantation location is an anterior-posterior reservoir location (¶[0178]) to allow the treatment of a variety of ocular conditions, such as diseases, tumors, and disorders (¶[0176]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method of Joseph/Nissan so that the implantation location is an anterior-posterior reservoir location, as taught by Nivaggioli to allow the treatment of a variety of ocular conditions, such as diseases, tumors, and disorders (as motivated by Nivaggioli ¶[0176]).
Regarding Claim 17, Joseph/Nissan is silent whether the one or more eye diseases includes at least one of macular degeneration, geographic atrophy lesion, macular edema, uveitis, retinitis, central retinal vein occlusion, or branch retinal vein occlusion.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein the one or more eye diseases includes at least one of macular degeneration, geographic atrophy lesion, macular edema, uveitis, retinitis, central retinal vein occlusion, or branch retinal vein occlusion (¶[0096]) to prevent or reduce the occurrence of loss of vision (¶[0096]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Joseph/Nissan so that the one or more eye diseases includes at least one of macular degeneration, geographic atrophy lesion, macular edema, uveitis, retinitis, central retinal vein occlusion, or branch retinal vein occlusion, as taught by Nivaggioli to prevent or reduce the occurrence of loss of vision (as motivated by Nivaggioli ¶[0096]).
Claims 10-11, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph (US 6471689 B1) in view of Nissan (US 20130325024 A1), further in view of Nivaggioli (US 20050244465 A1), further in view of Campbell (US 20210205130 A1).
Regarding Claim 10, Joseph/Nissan/Nivaggioli is silent whether when the one or more diseases is macular degeneration, the medicament has an API class that includes monoclonal antibodies, antibody mimetic proteins, peptides, or small binding molecules.
However, Campbell teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is macular degeneration (¶[0105]), the medicament has an API class that includes monoclonal antibodies, antibody mimetic proteins, peptides, or small binding molecules (¶[0108-0109]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan/Nivaggioli so that when the one or more diseases is macular degeneration, the medicament has an API class that includes monoclonal antibodies, antibody mimetic proteins, peptides, or small binding molecules, to ameliorate the symptoms of macular degeneration. One of ordinary skill would recognize that substituting the medicament of Joseph/Nissan/Nivaggioli for the ocular medicament of Campbell is a simple substitution of one known fluid medication for another known fluid medication.
Regarding Claim 11, Joseph/Nissan/Nivaggioli is silent whether when the one or more diseases is macular edema, the medicament has an API class that includes monoclonal antibodies, antibody mimetic proteins, peptides, small binding molecules, or steroids.
However, Campbell teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is macular edema (¶[0105]), the medicament has an API class that includes monoclonal antibodies, antibody mimetic proteins, peptides, small binding molecules, or steroids (¶[0108-0109]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan/Nivaggioli so that when the one or more diseases is macular edema, the medicament has an API class that includes monoclonal antibodies, antibody mimetic proteins, peptides, small binding molecules, or steroids to ameliorate the symptoms of macular edema. One of ordinary skill would recognize that substituting the medicament of Joseph/Nissan/Nivaggioli for the ocular medicament of Campbell is a simple substitution of one known fluid medication for another known fluid medication.
Regarding Claim 14, Joseph/Nissan/Nivaggioli is silent whether when the one or more diseases is retinoblastoma, the medicament has an API class that includes cytotoxic chemotherapy compounds.
However, Campbell teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is retinoblastoma (¶[0049]), the medicament has an API class that includes cytotoxic chemotherapy compounds (¶[0108]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan/Nivaggioli so that when the one or more diseases is retinoblastoma, the medicament has an API class that includes cytotoxic chemotherapy compounds to ameliorate the symptoms of retinoblastoma. One of ordinary skill would recognize that substituting the medicament of Joseph/Nissan/Nivaggioli for the ocular medicament of Campbell is a simple substitution of one known fluid medication for another known fluid medication.
Regarding Claim 18, Joseph/Nissan/Nivaggioli is silent whether when the one or more diseases is macular degeneration, the medicament has an API class that includes monoclonal antibodies, antibody mimetic proteins, peptides, or small binding molecules.
However, Campbell teaches an implantable therapeutic device, thus from the same field of endeavor, wherein when the one or more diseases is macular degeneration (¶[0105]), the medicament has an API class that includes monoclonal antibodies (¶[0109]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medicament of Joseph/Nissan/Nivaggioli so that when the one or more diseases is macular degeneration, the medicament has an API class that includes monoclonal antibodies to ameliorate the symptoms of macular degeneration. One of ordinary skill would recognize that substituting the medicament of Joseph/Nissan/Nivaggioli for the ocular medicament of Campbell is a simple substitution of one known fluid medication for another known fluid medication.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph (US 6471689 B1) in view of Nivaggioli (US 20050244465 A1).
Regarding Claim 19, Joseph discloses an implantable medical device pre-loaded with a therapeutic agent (Fig 1-3 Col 11 ln 52-54 drug delivery device 12 may be loaded with a drug at any point via drug feed device 18), the implantable medical device comprising: a first microporous material (Fig 3, see annotated figure 1, combination of ingrowth permitting layer 1 and ingrowth resisting layer 2) bonded to a second microporous layer (Fig 3, see annotated figure 1, combination of ingrowth permitting layer 4 and ingrowth resisting layer 3) to define a reservoir disposed therebetween (Fig 3 Col 7 ln 17-19 reservoir 23); the reservoir configured for containing the therapeutic agent (Fig 3 Col 7 ln 17-19 reservoir 23 for containing and dispersing drugs), and the implantable medical device configured to release the therapeutic agent at a predetermined rate (Fig 3, Col 9 ln 27-43, pore size, thickness, and surface area influence medication diffusion, thus the pore sizes of layers 32 and 30 meter a medicament diffusion rate).
Joseph is silent whether the therapeutic agent is at least one of latanoprost, timolol, brimonidine, or dorzolamide.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein the therapeutic agent is at least one of timolol or brimonidine (¶[0051]) in order to prevent loss of vision due to glaucoma (¶[0051][0096]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Joseph so that the therapeutic agent is at least one of timolol, brimonidine as taught by Nivaggioli in order to prevent loss of vision due to glaucoma (as motivated by Nivaggioli ¶[0051][0096]).
Regarding Claim 20, Joseph discloses an implantable medical device for delivering a therapeutic agent for treatment of a disease (Fig 1-3 Col 11 ln 52-54 drug delivery device 12 may be loaded with a drug at any point via drug feed device 18), the implantable medical device comprising: a first microporous material (Fig 3, see annotated figure 1, combination of ingrowth permitting layer 1 and ingrowth resisting layer 2) bonded to a second microporous layer (Fig 3, see annotated figure 1, combination of ingrowth permitting layer 4 and ingrowth resisting layer 3) to define a reservoir disposed therebetween (Fig 3 Col 7 ln 17-19 reservoir 23); the reservoir configured for containing a pharmaceutical composition and to deliver the therapeutic agent to a target site for treating the disease (Fig 3 Col 7 ln 17-19 reservoir 23 for containing and dispersing drugs).
Joseph is silent whether the treatment is configured for treating one or more of glaucoma, macular degeneration, macular edema, retinitis, retinoblastoma, retinal vein occlusions, keratitis, and dry eye.
However, Nivaggioli teaches an implantable therapeutic device, thus from the same field of endeavor, wherein the treatment is configured for treating one or more of glaucoma, macular degeneration, macular edema, retinitis, retinoblastoma, retinal vein occlusions (¶[0095-0096]) in order to prevent loss of vision due to glaucoma (¶[0051][0096]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Joseph so that the treatment is configured for treating one or more of glaucoma, macular degeneration, macular edema, retinitis, retinoblastoma, retinal vein occlusions as taught by Nivaggioli in order to prevent loss of vision due to glaucoma (as motivated by Nivaggioli ¶[0051][0096]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781