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 .
Claims 1-19 are pending and currently under consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-11, 13, 16, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “…via the PEG moiety….” There is insufficient antecedent basis for “the PEG moiety” in the claim.
Claims 7-11, 13, 16, and 17 are rejected because it is unclear how, or if, limitations following the term “preferably” limit the claims. Therefore, the metes-and-bounds of the claims are unclear.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 7, 9-11, and 13-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Ni et al (US 2019/0030179 A1; 1/31/19) in view of Liu et al (International Journal of Nanomedicine, 2019, 14: 8819-8834).
Ni et al teaches a method of producing synergistic and enhanced efficacy in treating a disease in a subject comprising treating the disease with an antibody-drug synergism (ADS) compound comprising an antibody that blocks a first target in the subject connected via a hydrolysable linker to a small molecule drug that blocks the first target or a second target in the subject ([0004], in particular). Ni et al further teaches said method wherein the disease is an ocular disease ([0005], in particular) and wherein the ADS is delivered to the eye and the linker hydrolyzes in vitreous humor and ocular tissue ([0033], in particular). At [0029] and [0035], Ni et al further teaches said method wherein the disease is age-related macular degeneration (AMD) and wherein the treatment is for choroidal neovascularization (CNV). Ni et al further teaches said method wherein the linker is hydrolyzed with a half-life of 1-24 hours ([0013], in particular). Ni et al further teaches ADS where the antibody is bevacizumab and the small molecule drug is slowly released from the ADS and maintains an effective concentration before the parent ADS is cleared ([0037], in particular), which is a “controlled release fashion.” Ni et al further teaches said method wherein the ADS is PEGylated ([0017], in particular). Ni et al further teaches said method wherein the linker can be esters, amides, carbamates, carbonates, imines, ethers, or phosphates ([0033], in particular).
Ni et al does not specifically teach said method wherein the small molecule drug is dexamethasone. However, these deficiencies are made up in the teachings of Liu et al.
Liu et al teaches choroidal neovascularization (CNV) is the main cause of vision impairment in age-related macular degeneration (AMD) that can be treated by targeting VEGF with dexamethasone and bevacizumab (Abstract, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method to prevent vision impairment in a subject with AMD comprising the method of Ni et al to treat CMV in a subject with AMD wherein the ADS comprises bevacizumab of Ni et al linked to dexamethasone of Liu et al as the small molecule inhibitor because Ni et al teaches ADS synergistically treat ocular diseases, such as AMD, by administering a therapeutic antibody linked to a therapeutic small molecule the target the disease and Liu et al teaches SNV is the main cause of vision impairment in AMD that can be treated by targeting VEGF with dexamethasone and bevacizumab (Abstract, in particular). This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claims 1-3, 7, 9-11, and 13-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Ni et al (US 2019/0030179 A1; 1/31/19) in view of Vakalis et al (Scientific Reports, 2015, 5(8627): 1-6).
Ni et al teaches a method of producing synergistic and enhanced efficacy in treating a disease in a subject comprising treating the disease with an antibody-drug synergism (ADS) compound comprising an antibody that blocks a first target in the subject connected via a hydrolysable linker to a small molecule drug that blocks the first target or a second target in the subject ([0004], in particular). Ni et al further teaches said method wherein the disease is an ocular disease ([0005], in particular) and wherein the ADS is delivered to the eye and the linker hydrolyzes in vitreous humor and ocular tissue ([0033], in particular). At [0029] and [0035], Ni et al further teaches said method wherein the disease is age-related macular degeneration (AMD) and wherein the treatment is for choroidal neovascularization (CNV). Ni et al further teaches said method wherein the linker is hydrolyzed with a half-life of 1-24 hours ([0013], in particular). Ni et al further teaches ADS where the antibody is bevacizumab and the small molecule drug is slowly released from the ADS and maintains an effective concentration before the parent ADS is cleared ([0037], in particular), which is a “controlled release fashion.” Ni et al further teaches said method wherein the ADS is PEGylated ([0017], in particular). Ni et al further teaches said method wherein the linker can be esters, amides, carbamates, carbonates, imines, ethers, or phosphates ([0033], in particular).
Ni et al does not specifically teach said method wherein the small molecule drug is dexamethasone. However, these deficiencies are made up in the teachings of Vakalis et al.
Vakalis et al teaches treating subjects with AMD by intravitreal delivering with dexamethasone and bevacizumab to target VEGF results in immediate response of macular edema and improved visual activity (Abstract, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method to prevent vision impairment in a subject with AMD comprising the method of Ni et al to treat a subject with AMD wherein the ADS comprises bevacizumab of Ni et al linked to dexamethasone of Vakalis et al as the small molecule inhibitor because Ni et al teaches ADS synergistically treat ocular diseases, such as AMD, by administering a therapeutic antibody linked to a therapeutic small molecule the target the disease and Vakalis et al teaches treating subjects with AMD by intravitreal delivering with dexamethasone and bevacizumab to target VEGF results in immediate response of macular edema and improved visual activity (Abstract, in particular). This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1-3, 7-11, and 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ni et al (US 2019/0030179 A1; 1/31/19) in view of Liu et al (International Journal of Nanomedicine, 2019, 14: 8819-8834) as applied to claims 1-3, 7, 9-11, and 13-18 above, and further in view of Bezwada (US 2009/0082540 A1; 3/26/2009).
Teachings of Ni et al and Liu et al are discussed above.
Ni et al and Liu et al do not specifically teach a hydrolysable linker encompassed by instant claim 8. However, these deficiencies are made up in the teachings of Bezwada et al.
Bezwada teaches numerous hydrolysable linkers, including this linker of Formula VI on page 14 that encompasses a linker of instant claim 8:
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Bezwada further teaches the hydrolysable linkers can be administered by ocular route ([0286], in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of Ni et al and Liu et al wherein the hydrolysable linker is any hydrolysable linker of Bezwada because the combined method administers an ADS comprising a hydrolysable linker that is to be cleaved in vitreous humor and ocular tissue ([0033], in particular) and the hydrolysable linkers of Bezwada are taught be administered by an ocular route ([0286], in particular). This is an example of a simple substitution of one known hydrolysable liker for another to obtain predictable results. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1-3, 7-11, and 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ni et al (US 2019/0030179 A1; 1/31/19) in view of Vakalis et al (Scientific Reports, 2015, 5(8627): 1-6) as applied to claims 1-3, 7, 9-11, and 13-18 above, and further in view of Bezwada (US 2009/0082540 A1; 3/26/2009).
Teachings of Ni et al and Vakalis et al are discussed above.
Ni et al and Vakalis et al do not specifically teach a hydrolysable linker encompassed by instant claim 8. However, these deficiencies are made up in the teachings of Bezwada et al.
Bezwada teaches numerous hydrolysable linkers, including this linker of Formula VI on page 14 that encompasses a linker of instant claim 8:
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Bezwada further teaches the hydrolysable linkers can be administered by ocular route ([0286], in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of Ni et al and Vakalis et al wherein the hydrolysable linker is any hydrolysable linker of Bezwada because the combined method administers an ADS comprising a hydrolysable linker that is to be cleaved in vitreous humor and ocular tissue ([0033], in particular) and the hydrolysable linkers of Bezwada are taught be administered by an ocular route ([0286], in particular). This is an example of a simple substitution of one known hydrolysable liker for another to obtain predictable results. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1-5, 7, 9-11, and 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ni et al (US 2019/0030179 A1; 1/31/19) in view of Liu et al (International Journal of Nanomedicine, 2019, 14: 8819-8834) as applied to claims 1-3, 7, 9-11, and 13-18 above, and further in view of Turecek et al (Journal of Pharmaceutical Sciences, 2016, 460-475).
Teachings of Ni et al and Liu et al are discussed above.
Ni et al and Liu et al do not specifically teach that the PEGylated antibody of the ADS of the combined method comprises a linear PEG moiety, a branched PEG moiety, or PEG moiety that is –(CH2-CH2-O-)n where n is 5-30. However, these deficiencies are made up in the teachings of Turecek et al.
Turecek et al teaches a single PEG chain has the structure equivalent to “–(CH2-CH2-O-)n” (Figure 1, in particular), multiple PEGs attached to a molecule are called “PEGmers” (right column on page 461, in particular), and commercial therapeutics include PEGmers where “n” is 6 (left column on page 469, in particular) or 11-17 (Table 1, in particular). Turecek et al teaches attaching PEG molecules is known to enhance pharmacologic and pharmaceutical properties of proteins and other large molecules (Abstract, in particular) and that attached PEG can be linear, branched, or (left column on page 468, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of Ni et al and Liu et al wherein the PEGylated antibody of the ADS of the combined method is PEGylated in any manner taught by Turecek et al because the ADS of the combined method is a large molecule construct and Turecek et al teaches attaching PEG molecules is known to enhance pharmacologic and pharmaceutical properties of proteins and other large molecules (Abstract, in particular). This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1-5, 7, 9-11, and 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ni et al (US 2019/0030179 A1; 1/31/19) in view of Vakalis et al (Scientific Reports, 2015, 5(8627): 1-6) as applied to claims 1-3, 7, 9-11, and 13-18 above, and further in view of Turecek et al (Journal of Pharmaceutical Sciences, 2016, 460-475).
Teachings of Ni et al and Vakalis et al are discussed above.
Ni et al and Vakalis et al do not specifically teach that the PEGylated antibody of the ADS of the combined method comprises a linear PEG moiety, a branched PEG moiety, or PEG moiety that is –(CH2-CH2-O-)n where n is 5-30. However, these deficiencies are made up in the teachings of Turecek et al.
Turecek et al teaches a single PEG chain has the structure equivalent to “–(CH2-CH2-O-)n” (Figure 1, in particular), multiple PEGs attached to a molecule are called “PEGmers” (right column on page 461, in particular), and commercial therapeutics include PEGmers where “n” is 6 (left column on page 469, in particular) or 11-17 (Table 1, in particular). Turecek et al teaches attaching PEG molecules is known to enhance pharmacologic and pharmaceutical properties of proteins and other large molecules (Abstract, in particular) and that attached PEG can be linear, branched, or (left column on page 468, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of Ni et al and Vakalis et al wherein the PEGylated antibody of the ADS of the combined method is PEGylated in any manner taught by Turecek et al because the ADS of the combined method is a large molecule construct and Turecek et al teaches attaching PEG molecules is known to enhance pharmacologic and pharmaceutical properties of proteins and other large molecules (Abstract, in particular). This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1-5 and 7-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ni et al (US 2019/0030179 A1; 1/31/19) in view of Liu et al (International Journal of Nanomedicine, 2019, 14: 8819-8834) and Turecek et al (Journal of Pharmaceutical Sciences, 2016, 460-475) as applied to claims 1-5, 7, 9-11, and 13-19 above, and further in view of Bezwada (US 2009/0082540 A1; 3/26/2009).
Teachings of Ni et al, Liu et al, and Turecek et al are discussed above.
Ni et al, Liu et al, and Turecek et al do not specifically teach a hydrolysable linker encompassed by instant claim 8. However, these deficiencies are made up in the teachings of Bezwada et al.
Bezwada teaches numerous hydrolysable linkers, including this linker of Formula VI on page 14 that encompasses a linker of instant claim 8:
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Bezwada further teaches the hydrolysable linkers can be administered by ocular route ([0286], in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of Ni et al, Liu et al, and Turecek et al wherein the hydrolysable linker is any hydrolysable linker of Bezwada because the combined method administers an ADS comprising a hydrolysable linker that is to be cleaved in vitreous humor and ocular tissue ([0033], in particular) and the hydrolysable linkers of Bezwada are taught be administered by an ocular route ([0286], in particular). This is an example of a simple substitution of one known hydrolysable liker for another to obtain predictable results. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1-5 and 7-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ni et al (US 2019/0030179 A1; 1/31/19) in view of Vakalis et al (Scientific Reports, 2015, 5(8627): 1-6) and Turecek et al (Journal of Pharmaceutical Sciences, 2016, 460-475) as applied to claims 1-5, 7, 9-11, and 13-19 above, and further in view of Bezwada (US 2009/0082540 A1; 3/26/2009).
Teachings of Ni et al, Vakalis et al, and Turecek et al are discussed above.
Ni et al, Vakalis et al, and Turecek et al do not specifically teach a hydrolysable linker encompassed by instant claim 8. However, these deficiencies are made up in the teachings of Bezwada et al.
Bezwada teaches numerous hydrolysable linkers, including this linker of Formula VI on page 14 that encompasses a linker of instant claim 8:
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Bezwada further teaches the hydrolysable linkers can be administered by ocular route ([0286], in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of Ni et al, Vakalis et al, and Turecek et al wherein the hydrolysable linker is any hydrolysable linker of Bezwada because the combined method administers an ADS comprising a hydrolysable linker that is to be cleaved in vitreous humor and ocular tissue ([0033], in particular) and the hydrolysable linkers of Bezwada are taught be administered by an ocular route ([0286], in particular). This is an example of a simple substitution of one known hydrolysable liker for another to obtain predictable results. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 7, 9-11, and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 6-8 of U.S. Patent No. 12214049 B2 in view of Ni et al (US 2019/0030179 A1; 1/31/19) and Liu et al (International Journal of Nanomedicine, 2019, 14: 8819-8834). Both patent and the instant claims are drawn to ADS compounds and/or administering ADS compounds to subjects with an ocular disease wherein the ADS compounds comprise bevacizumab antibody attached via a hydrolysable linker to a small molecule anti-angiogenesis inhibitor. The instant claims differ from the patent claims in that the patent claims do not recite the small molecule anti-angiogenesis inhibitor is dexamethasone or that bevacizumab of the ADS is PEGylated. However, these deficiencies are made-up by Ni et al and Liu et al.
Teachings of Ni et al and Liu et al are discussed above.
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method to prevent vision impairment in a subject with AMD comprising the method of Ni et al (encompassed by the patent claims) to treat CMV in a subject with AMD wherein the ADS comprises bevacizumab of Ni et al linked to dexamethasone of Liu et al as the small molecule inhibitor because Ni et al teaches ADS synergistically treat ocular diseases, such as AMD, by administering a therapeutic antibody linked to a therapeutic small molecule the target the disease and Liu et al teaches SNV is the main cause of vision impairment in AMD that can be treated by targeting VEGF with dexamethasone and bevacizumab (Abstract, in particular).
Claims 1-3, 7-11, and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 6-8 of U.S. Patent No. 12214049 B2 in view of Ni et al (US 2019/0030179 A1; 1/31/19) and Liu et al (International Journal of Nanomedicine, 2019, 14: 8819-8834), as applied to claims 1-3, 7, 9-11, and 13-18, and in further view of Bezwada (US 2009/0082540 A1; 3/26/2009).
Teachings of Bezwada are discussed above.
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of the patent claims, Ni et al, and Liu et al wherein the hydrolysable linker is any hydrolysable linker of Bezwada because the combined method administers an ADS comprising a hydrolysable linker that is to be cleaved in vitreous humor and ocular tissue ([0033], in particular) and the hydrolysable linkers of Bezwada are taught be administered by an ocular route ([0286], in particular). This is an example of a simple substitution of one known hydrolysable liker for another to obtain predictable results. See MPEP 2143.
Claims 1-5, 7, 9-11, and 13-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 6-8 of U.S. Patent No. 12214049 B2 in view of Ni et al (US 2019/0030179 A1; 1/31/19) and Liu et al (International Journal of Nanomedicine, 2019, 14: 8819-8834), as applied to claims 1-3, 7, 9-11, and 13-18, and in further view of Turecek et al (Journal of Pharmaceutical Sciences, 2016, 460-475).
Teachings of Turecek et al are discussed above.
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of the patent claims, Ni et al, and Liu et al wherein the PEGylated antibody of the ADS of the combined method is PEGylated in any manner taught by Turecek et al because the ADS of the combined method is a large molecule construct and Turecek et al teaches attaching PEG molecules is known to enhance pharmacologic and pharmaceutical properties of proteins and other large molecules (Abstract, in particular).
Claims 1-5 and 7-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 6-8 of U.S. Patent No. 12214049 B2 in view of Ni et al (US 2019/0030179 A1; 1/31/19), Liu et al (International Journal of Nanomedicine, 2019, 14: 8819-8834), and Turecek et al (Journal of Pharmaceutical Sciences, 2016, 460-475) as applied to claims 1-5, 7, 9-11, and 13-19 and in further view of Bezwada (US 2009/0082540 A1; 3/26/2009).
Teachings of Bezwada are discussed above.
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the combined method of the patent claims, Ni et al, Liu et al, and Turecek et al wherein the hydrolysable linker is any hydrolysable linker of Bezwada because the combined method administers an ADS comprising a hydrolysable linker that is to be cleaved in vitreous humor and ocular tissue ([0033], in particular) and the hydrolysable linkers of Bezwada are taught be administered by an ocular route ([0286], in particular).
Conclusion
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