Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1 and 3-28 are pending in the Claim Set filed 8/6/26/2025.
Claims 1 and 16 have been amended.
Applicants elected of a posterior ocular condition. e.g., macular degeneration (ARMD), such as non-exudative age-related macular degeneration and exudative age related macular.
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Herein, claims 1, 3 and 5-28 are for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/03/2022 and 10/26/2025 have been considered by the examiner and an initialed copy of the IDS is included with the mailing of this office action.
Withdrawn Rejections
The rejection of claims 1-3 and 5-28 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Inventor Robinson (US20090081277) in view of Cleemann (WO2012035139) is withdrawn in view of the claim amendments.
Specification (Abstract)
The Abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should avoid using phrases which can be implied, such as: The present invention relates to a method of preventing, diagnosing and/or treating an ocular condition. In particular, the method comprises the step of administering a therapeutically effective amount of a pharmaceutical composition comprising a hydrogel-linked prodrug to a patient in need thereof.
The objection to the Abstract is maintained and made again necessitated by the Applicants amendments thereof filed 8/26/2025.
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 of this title, 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 negatived by the manner in which the invention was made.
Claims 1, 3, 5-10 and 28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rau et al (WO2011012715, cited in IDS, filed 10/02/2022) [Rau] in view of Rabinovich-Guilatt et al (US20070281913, cited in IDS, filed 10/02/2022) [Rabinovich-Guilatt] and Billison et al. (USP 5770589).
Regarding claims 1, 3, 5, 7-10 and 28,
Rau teaches a method of treating, controlling, delaying or preventing in a mammalian patient, preferably in a human, in need of the treatment of one or more conditions comprising administering to said patient a therapeutically effective amount of a hydrogel prodrug of the present invention or a pharmaceutical composition of the present invention or a pharmaceutically acceptable salt thereof (p.145, lns.19-25; claims 25, 53). Rau teaches a pharmaceutical composition comprising biodegradable polyethylene glycol-based hydrogels comprising a carrier-linked prodrug(s) (p.1, lns.1-9; p.3, lns.18-22; p.4, lns.6-14; p.143, lns.20-25; p.144, lns.21-27; p.145, lns.19-23; See entire document). Rau teaches the bioactive drug is a peptide (at least at p.53; p.98; p.100; p.103; p.110; p.112.). Further, Rau teaches that the biologically actives, e.g., steroidal agents, are intended for the treatment or prevention of disease in humans or other animals, or to otherwise enhance physical or mental well-being of humans or animals (p.7, lns.1-9; p.145, lns,19-23; See entire document). In particular, Rau teaches the drug is triamcinolone acetonide (steroid) (p.125, line 3). Rau teaches that it is preferred for the linking agent to form a reversible linkage to the biologically active moiety, preferably in such a fashion that after cleavage of the linker, the biologically active moiety is released in an unmodified form (reads on free form) (p.25, lns.19-23; p.52, lns.11-15).
Rau teaches hydrogel beads having a diameter of 32, 40 and 50 micrometers (p.154, lns.15-20; claim 69).
Rau teaches the term "reversible" refers within the context of the present invention to bonds and linkages which are non-enzymatically hydrolytically degradable or cleavable under physiological conditions, i.e., aqueous buffer at pH 7.4, at 37oC (p.4, lns.6-10;
Rau teaches a PEG-based cross linker comprising activated esters groups (Rau: pages 136 and 137; claims 7 and 55), as follows:
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Rau teaches a biodegradable hydrogel-linked prodrug, wherein the hydrogel comprises a backbone structure corresponding to formula (I) (See Instant Claim 16): B(-(A0)x1-(SP)x2-A1 - P - A2 - Hyp1)x (I); where the (SP) = X = 0; (P) is PEG based and A1 = -C(O)- and A2 = -NR-C(O) as follows (See Rau: Claim 37):
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and HYP1 is as follows (See Rau: Claim 35:
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and B = branching core. Rau teaches branching cores (p.8, lns.33-35 to p.9, lns.1-35; See Title page and entire document), for example, tripentaerythritol (p.9, line 33); wherein the carrier-linked prodrug comprises a linkage that is a carbamate, carbonate, amide or ester linkage (Rau: claim 16).
Regarding claim 6,
Rau teaches hydrogel-linked prodrug administered from a needle (i.e., container) (p.142, lns.33-35; claim 69).
Rau differs from the claims in that the document does not explicitly teach administering the hydrogel-linked prodrug by intravitreal injection into the vitreous body or ocular condition. e.g., macular degeneration (ARMD.
However, Rabinovich-Guilatt and Billison cures this deficiency.
Rabinovich-Guilatt teaches the use of prodrug for the manufacture of a medicament useful for treating an ocular disease affecting the posterior segment of the eye, e.g., macular disorders, e.g., Disorders such as myopia, Non-Exudative Age Related Macular Degeneration, Exudative Age Related Macular Degeneration: [0036]; claim 14, in a subject in need thereof, wherein the prodrug is a composition injected into the vitreous body (Abstract). Rabinovich-Guilatt teaches the use of prodrugs of ophthalmic active drugs for the preparation of a medicament or an ophthalmic composition intended for the treatment of an ocular condition or disease of a human being or an animal, said medicament or ophthalmic composition being administered by invasive means, preferably by intraocular injection, more preferably by intravitreal injection, for in-situ sustained release of a therapeutic effective amount of drug in the posterior segment of the eye [0011]. In particular, Rabinovich-Guilatt teaches that the drug is triamcinolone salts ([0042; [0046]; claim 12). Further, Rabinovich-Guilatt teaches treatments of posterior eye diseases require intravitreal or periocular injections or systemic drug administration, whereas local injections are usually preferred to systemic drug administration because the blood/retinal barrier impedes the passage of most drugs from the systemically circulating blood to the interior of the eye. Therefore, large systemic doses are needed to treat eye posterior diseases, which often result in systemic toxicities. There are diseases for which periocular injections do not allow the delivery of efficacious amounts to the target sites, for these diseases, intravitreal injections are found necessary ([0004]; [0005]). It well established that intravitreal injection is a procedure where medication is injected directly into vitreous humor. Specification at page2 states: Intravitreal injections are commonly used to deliver therapeutic agents to the eye, particularly to the vitreous humor of the eye for treatment of ophthalmic maladies such as age related macular degeneration (AMD) (para. [0036]; claim 14).
Billison et al. (USP 5770589), teaches that triamcinolone acetonide is used to treat macular degeneration (AMD) delivered by intravitreal injection: An effective amount of triamcinolone acetonide to arrest and/or reverse macular degeneration is administered by intravitreal injection (col.4, lns.1-6; Ex. 3; see entire document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide a method for treating ocular conditions, e.g., macular degeneration (ARMD., by administering a therapeutically effective amount of a pharmaceutical composition comprising a hydrogel-linked prodrug to a patient in need thereof by intravitreal injection into the vitreous body in view of the teachings of Rau and Rabinovich-Guilatt. and Billison, as a whole. One skilled in the art would been motivated to modify the teachings of Rau to provide a method of delivery a hydrogel-linked prodrug for the treatment of macular degeneration (AMD), wherein the hydrogel-linked prodrug is preferably delivered by intravitreal injection in view of the teachings of Rabinovich-Guilatt. One skilled in the art would have recognized the advantage of intravitreal injection since Rabinovich-Guilatt teaches treatments of posterior eye diseases require intravitreal or periocular injections or systemic drug administration, whereas local injections are usually preferred to systemic drug administration because the blood/retinal barrier impedes the passage of most drugs from the systemically circulating blood to the interior of the eye. Therefore, large systemic doses are needed to treat eye posterior diseases, which often result in systemic toxicities. There are diseases for which periocular injections do not allow the delivery of efficacious amounts to the target sites, for these diseases, so that intravitreal injections are necessary. Furthermore, Billison et al. teach that triamcinolone acetonide treats AMD via intravitreal injection rendering it obvious to utilize Rau’s triamcinolone acetonides which treats any condition to treat macular degeneration.
All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide instantly claimed antimicrobial composition and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the claimed invention as a whole would have been obvious to one of ordinary skill as evidenced by Rau and Rabinovich-Guilatt, as a whole.
Claims 11-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rau et al (WO2011012715, cited in IDS, filed 10/02/2022) [Rau] in view of Rabinovich-Guilatt et al. (US20070281913, cited in IDS, filed 10/02/2022) [Rabinovich-Guilatt] and Billison et al. (USP 5770589) as applied to claims 1, 3, 5-10 and 28 above and further in view of Cleemann (WO2012035139).
The teachings of Rau and Rabinovich-Guilatt, as a whole, are described above.
Regarding claims 11-27,
The recitation of a process limitation is not viewed as positively limiting the claimed method of treating an ocular condition absent a showing that the process of making imparts a novel or unexpected property to the claimed product, as it is assumed that equivalent products are obtainable by multiple routes. "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.
For instance, if the hydrogel in a product-by-process claim (e.g., claim 12) is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP 2113.
As described above, Rau teaches a pharmaceutical composition comprising a hydrogel-linked prodrug. Thus, the recitation of process limitation(s) as recited in claims 11-27 are not viewed as positively limiting the claimed product absent a showing that the process of making imparts a novel or unexpected property to the claimed product, as it is assumed that equivalent products are obtainable by multiple routes.
Particularly, Rau teaches a process for preparation of a hydrogel comprising (as shown below):
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in ratio of 2:1 in a solvent (i.e., reagents are mixed in a ratio amine/active ester of 2:1 to 1.05:1 and are dissolved in DMSO (i.e., first solvent), wherein a second solvent is used that is not miscible (immiscible) with DMSO- See Rau: page 141, lines.10-25) (Rau: claims 54-68; See entire document).
All and all, the teachings of Rau and Rabinovich-Guilatt, as a whole, make obvious a method of preventing, diagnosing and/or treating an ocular condition comprising a pharmaceutical composition comprising a hydrogel-linked prodrug, as instantly claimed.
Regarding claims 11-27,
The recitation of a process limitation is not viewed as positively limiting the claimed method of treating an ocular condition absent a showing that the process of making imparts a novel or unexpected property to the claimed product, as it is assumed that equivalent products are obtainable by multiple routes. "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.
For instance, if the hydrogel in a product-by-process claim (e.g., claim 12) is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP 2113.
To further prosecution of instantly claimed invention the teachings of Cleemann are made of record to address the limitations of claims 11-17.
Cleemann teaches a biodegradable hydrogel-linked-prodrug comprising a backbone moiety comprising a hyperbranched moiety Hyp, as shown below, where the dashed lines indicate interconnecting biodegradable linkages to cross-linker moieties and n is an integer of from 5 to 50 and further comprising PEG groups (p.41, lns.1-4; 44, lns.1-10).
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Further, Cleemann teaches backbone moieties are attached to at least one spacer of the following formula:
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wherein the dashed line marked with the asterisk indicates the bond between the hydrogel (p.42, lns.13-15).
Cleemann teaches that the backbone reagent and cross-linker reagent is polymerized to form the hydrogel according to the invention using inverse emulsion polymerization (p.45, lns.67). Cleemann teaches that the hydrogel-spacer-biologically active agent is used to treat macular degeneration (p.64)
Cleemann teaches that the linkers employed in such carrier-linked prodrugs may be transient, meaning that they are non-enzymatically hydrolytically degradable (cleavable) under physiological conditions (aqueous buffer at pH 7.4, 37°C) with half-lives ranging from, for example, one hour to three months. Suitable carriers are polymers and can either be directly 10 conjugated to the linker or via a non-cleavable spacer (p.2; lns.5-15). Transient polymer conjugation through traceless prodrug linkers combines the advantages of prolonged circulation times due to polymer attachment and the recovery of the original pharmacology of the native peptide after release from the polymer conjugate.
Regarding claims 9 and 10,
Cleemann teaches hydrogel-linked prodrug beads having a diameter of between 25-80 micrometers (p.52, lns.13-20).
Regarding claims 11 and 15-27,
Cleemann teaches biodegradable hydrogel-linked prodrug (discussed above), wherein the hydrogel is obtained by a process comprising the steps:
Cleemann teaches providing a mixture comprising: at least one backbone reagent, wherein the at least one backbone reagent has a molecular weight ranging from 1 to 100 kDa, and comprises at least three amines (-NH2 and/or-NH-) (reads step (a): (a-i):
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Cleemann teaches 1g: Synthesis backbone reagent 1g: See Example 1, pages 68-70 (1a-1b-1c-1d-1e-1f-1g); alternate synthetic route pages 70-72) (1g: structure shown below)
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which reads on backbone reagent B(- (A0)xt - (SP)x2 -A1- p -A2 - Hyp1)x that is represented by (i) in Instant Claim 15. Notably, Instant Specification on page 27 states that this reagent is a preferred backbone reagent.
Cleemann teaches at least one PEG-based crosslinker reagent, wherein the at least one PEG-based crosslinker reagent has a molecular weight ranging from 6 to 40 kDa, the at least one PEG-based crosslinker reagent comprising: Cleemann teaches (i) at least two carbonyloxy groups (-{C=0}-0-or-O-(C=O)--); (ii) at least two activated functional end groups selected from the group consisting of activated ester groups and (iii) at least 70% PEG (pages 69-72):
Cleemann teaches 2d: activated ester (shown below) (reads on a-ii) (also, crosslinker linker V-4 in claim 27):
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Further, Cleemann teaches a first solvent and at least a second solvent, which second solvent is immiscible in the first solvent: Cleemann teaches DMSO (first solvent and heptane)second solvent) (p.74, lns.1-13), wherein the above method steps are identical to the claimed method steps, so that it would necessarily follow that the mixture would be an emulsion as claimed (claim 14) (reads on a-iii)
Cleemann teaches polymerizing the mixture of step (a) in a suspension polymerization to a Hydrogel (reads on (b)). Step (c) is optional; however, it would be within the purview of those skilled in the art at the time of the invention to further provide a step (c) of working-up the hydrogel without undue experimentation. Notably, claim scope is not limited by claim language that makes optional MPEP 2111.04.
The method steps (a)(ai, a-ii, and a-iii) and (b) as taught by Cleemann are identical to the claimed method steps in claim 11, so that it would necessarily follow that the mixture would be an emulsion as claimed (claim 14).
Regarding claims 12-14,
Cleemann teaches surfactant detergent alrlacel P135 (p.74); base TMEDA to effect polymerization (claim 12); Cleemann teaches base TMEDA to effect polymerization (claim 13); the method steps (a)(ai, a-ii, and a-iii) and (b) as taught by Cleemann are identical to the claimed method steps in claim 11, so that it would necessarily follow that the mixture would be an emulsion as claimed (claim 14). Moreover, Cleemann teaches backbone reagent and crosslinker reagent may be polymerized to form the hydrogel according to the invention using inverse emulsion polymerization (p.45, lns.5-15; also emulsion: p.48, lns.16-17; 30-32; p.56, lns.28-30).
Moreover, Cleemann teachers that the process can be provided using a peptide (exendin) (p.63; See entire document), which reads on claim 28. Thus, it would have been prima facie obvious to one skilled in the art to use the process of preparing a pharmaceutical composition as taught by Cleemann to prepare a hydrogel-linked prodrug, as instantly claimed, having a reasonable expectation of success.
All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide instantly claimed antimicrobial composition and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the claimed invention as a whole would have been obvious to one of ordinary skill as evidenced by Rau, Rabinovich-Guilatt, and Cleemann, as a whole.
Response to Arguments
Arguments filed 8/26/2025.
Applicant argue that the present invention relates to a method of preventing, diagnosing and/or treating an ocular condition comprising the administration of a hydrogel-linked prodrug via intravitreal injection into the vitreous body (Amended Claim 1). Claim 1 as amended further specifies the hydrogel-linked prodrug as the following. Each of these three elements fulfills a particular function: a hydrogel carrier in the shape of beads which have a diameter of 1 to 1000 µm (microparticulate beads); biologically active moieties; and reversible prodrug linkers from which the biologically active moieties are released as the corresponding free drug form.
Applicant argue that the hydrogel carrier, designed as microparticulate beads with diameters ranging from 1 to 1000 µm, serves to prevent the rapid clearance of biologically active moieties from the eye by extending their clearance half-life. The vitreous network, primarily composed of hyaluronic acid, has an approximate mesh size of 500 nm. Studies indicate that bovine vitreous body acts as an impermeable elastic barrier for particles measuring 1190 nm or larger, while it is highly permeable to non-adhesive objects smaller than 510 nm in diameter. Accordingly, hydrogel-linked prodrugs in microparticulate bead form are anticipated to diffuse at a slower rate than their free drug counterparts, thereby decreasing both the clearance from the aqueous humor and uptake by macrophages present in ocular tissues.
Applicants argue that the primary role of the hydrogel carrier is thus to function as an insoluble scaffold, thereby protecting the biologically active moieties from degradation. Supporting this, Example 10 demonstrates that hydrogel microparticles remain detectable up to 14 days post-injection in rabbit eyes (para. [0867] to [0869] application as filed). This prolonged intraocular retention of the biologically active moiety as part of the prodrug, compared to the free drug, enables less frequent dosing, significantly reducing the treatment burden for patients, especially given the discomfort associated with intraocular injections.
The reversible prodrug linkers ensure that the biologically active moieties are connected to the hydrogel carrier, which is required to extend the release half-life, but which also ensures that the biologically active moieties are released over time to exhibit its full activity. Importantly, the reversible prodrug linker moiety releases the biologically active moieties in their free and unmodified drug form, which will have the same therapeutic activity as the known unmodified biologically active moieties. The biologically active moieties, which are released as the corresponding biologically active drugs in their free and unmodified form, are the active agents that ensures the treatment effect. As they are released in an unmodified form, their mode of action, pharmacokinetics and pharmacodynamics are well understood and predictable.
Applicant argue that the interplay of these three elements overcomes the known limitations associated with intravitreal injections into the vitreous chamber, such as undesirably high concentrations of therapeutic agent or lack of duration of action due to rapid drug clearance (see e.g. paragraphs [0007] and [0008] application as filed).
Applicant argue that while the present invention teaches a method in which a hydrogel-linked prodrug is administered via intravitreal injection into the vitreous body, Applicants argue the Robinson teaches an alternative approach of administering a polymeric drug delivery system to an anterior ocular location, in particular the sub-Tenon's space. Applicants argue that nothing in Robinson would motivate a person skilled in the art to change the injection site of the polymeric drug delivery system from the anterior ocular location to the vitreous body.
Applicants argue that the administration of the pharmaceutical formulations to an anterior ocular location, in particular the anterior sub-Tenon space, is at the core of the invention disclosed by Robinson. Applicants argue that Robinson highlights the disadvantages of intravitreal injections in para. [0017], which states: Techniques such as intravitreal injection of a drug have shown promising results, but due to the short intraocular half-life of active agent, such as glucocorticoids (approximately 3 hours), intravitreal injections must be frequently repeated to maintain a therapeutic drug level. In turn, this repetitive process increases the potential for side effects such as retinal detachment, endophthalmitis, and cataracts. In para. [0070], Robinson describes as one reason for selecting the anterior sub-Tenon space a slower rate of drug clearance. The ciliary body region does not show a rapid rate of drug clearance. Hence, we postulate that a therapeutic agent administered by an intraocular administration, such as by a subconjunctival injection, at the equator of the eye can from that location enter the eye to reach the ciliary body region. Further, Applicants argue that we (Robinson) selected the anterior sub-Tenon space as a preferred location for administration of a drug delivery system because from this location a therapeutic agent released from a drug delivery system we would expect to diffuse to or be transported to the ciliary body region (the target tissue).
Accordingly, Example 1 of Robinson sets out to test the residency time of the polymeric drug delivery systems when administered to an intraocular location, such as the sub-tenon space (para. [0095]). Applicants argue that Robinson unexpectedly found that "(anterior intraocular administered) polymeric vehicle with significant amounts of drug contained therein would by some unknown transport mechanism migrate to the back of the eye (para. 0096]). Applicants argue that Robinson utilizes this mechanism for delivery of the polymeric drug delivery system to a posterior ocular location. Para. [0101] to [0103] of Robinson teach that the tested formulations can be administered by subconjunctival periocular administration, injection into the sub-tenon's space and retrobulbar injection. Applicants argue that Robinson states intravitreal injection into the vitreous body is not shown as a suitable administration route for intraocular administration of the disclosed formulations.
Applicants argue that Robinson teaches to inject the disclosed drug delivery systems into an anterior location of the eye, in particular the sub-Tenon's space. Starting from Robinson, a person skilled in the art would be discouraged from using intravitreal injections for administration of the drug delivery systems, e.g. due to the rapid drug clearance in the intravitreal space.
Applicants argue that even if a person skilled in the art were to replace or modify the drug delivery systems of Robinson with or according to the hydrogel-linked-prodrugs of Cleemann, the person skilled in the art would still not arrive at the claimed method of treating an ocular condition, which requires the intravitreal injection into the vitreous body. Applicants argue that Cleemann teaches exendin linker conjugates comprising hydrogels as carriers but provides no indication that such conjugates are suited for intraocular administration. Even though different forms of administration are listed on page 51/line 17 and page 58/lines 10 to 13, intraocular injection in general and intravitreal injection into the vitreous body in particular, are not disclosed.
Further, Applicants argue that Cleemann is silent on treating an ocular condition with the disclosed exendin linker conjugates comprising hydrogels. While Cleemann discloses that patients in need of treatment with the long acting exendin compositions are at high risk of developing comorbidities, the combination of long acting exendin conjugates with appropriate bioactive compounds may be used, e.g., for the prevention, delay of progression or treatment of diseases and disorders selected from the group consisting of diabetic retinopathy, macular degeneration and cataract (pages 63/last paragraph and 64/first paragraph). Applicants argue that this means that in case the patients treated with long acting exendin develop additional conditions such as diabetic retinopathy, macular degeneration and cataract, they can be treated concomitantly with appropriate drugs. Applicants argue that Cleemann does not teach or suggest that appropriate drugs for the treatment of diabetic retinopathy, macular degeneration and cataract, should be linked to hydrogels to obtain hydrogels- linked prodrugs, but co-administered in their unmodified form (Applicants provided no reference to where this is found in the application as filed) Applicants argue, therefore, Cleemann provides no indication that hydrogel-linked-prodrugs are useful for treating ocular conditions by intravitreal injection into the vitreous body and does not provide a person skilled in the art with any motivation to change the route of administration of the polymeric drug delivery systems as taught by Robinson. There are diseases for which periocular injections do not allow the delivery of efficacious amounts to the target sites, for these diseases, so that intravitreal injections are necessary.
Applicant’s arguments have been fully considered but they are not persuasive, because, firstly, the teachings of Robinson are not used in the above 103 rejections. So that Applicants arguments that Cleemann does not cure the deficiencies of Robinson are moot. Secondly, Rabinovich-Guilatt cures the deficiencies of Rau. Rabinovich-Guilatt teaches, in part, there are diseases for which periocular injections do not allow the delivery of efficacious amounts to the target sites, for these diseases, so that intravitreal injections are necessary. In particular, Rabinovich-Guilatt teaches treating macular disorders, e.g., Disorders such as myopia, Non-Exudative Age Related Macular Degeneration, by intravitreal injection into the vitreous body.
Conclusions
No claim is allowed.
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.
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/T.W./Examiner, Art Unit 1619
/SARAH ALAWADI/Primary Examiner, Art Unit 1619