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 .
Election/Restrictions
Applicant's election without traverse of the following species in the reply filed on 01/21/2026 is acknowledged:
A pharmaceutical composition wherein "the thickness at a site of injection after suprachoroidal administration of the pharmaceutical composition is equal to or higher as compared to a thickness at a site of injection after suprachoroidal administration of a reference pharmaceutical composition, wherein the reference pharmaceutical composition comprises the recombinant AA V comprising the expression cassette encoding the transgene, wherein an amount of the recombinant AA V genome copies is the same when the pharmaceutical composition or the reference pharmaceutical composition is administered to the suprachoroidal space, and wherein the reference pharmaceutical composition has a viscosity of at most about 24 cP as measured at a shear rate of at most about 1 s- 1 ." See
claim 3(c).
Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims Status
Claims 2, 4-12, 14, 16-17, 19, 22-47, 49-55, 58-62, 64, 66-71, 73-79, and 87-88 are cancelled, no claims are withdrawn and claims 1, 3, 13, 15, 18, 20-21, 48, 56-57, 63, 65, 72 and 80-86 have been considered on the merits.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2021/053759, filed 10/06/2021.
Applicant' s claim for the benefit of a prior-filed parent provisional application 63/147,527 filed on 02/09/2021, 63/088,826 filed 10/07/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is 10/07/2020.
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 1, 3, 13, 15, 18, 20-21, 48, 56-57, 63, 65, 72 and 80-86are 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.
Regarding claims 1, 3, 15, and 72: The claims recite the term “at most about” and/or “at least about”.
The instant specification defines “about” as “within plus or minus 10% of a given value or range” (p84 [00155]).
As the term “at most” requires a number for the upper end, i.e. at the maximum requirement, and the term “about” does not provide clear boundary of the range (plus or minus 10%), one cannot determine the maximum number of the claimed range, and thus, it is indefinite by using “at most” and “about” together in defining the range in the claims.
The court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
For purposes of compact prosecution the phrase “at most about” is interpreted as “at most” and the phrase “at least about” is interpreted to mean “at least”.
Note claims 3, 13, 15, 18, 20-21, 48, 56-57, 63, 65, 72 and 80-86 depend from claim 1 and fail to cure the deficiency.
Regarding claim 63: The claim recites the limitation “the reference pharmaceutical composition”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 65, 83, 84 and 86: The claims recite “high viscosity grade”, “medium viscosity grade” and/or “low viscosity grade”.
The instant specification is silent on an explicit definition of “high”, “medium” and “low” viscosity grade. While “high viscosity grade”, “medium viscosity grade” and “low viscosity grade” CMC is known in the art, the characteristics are different depending on the source of the definition as evidenced by Tenessy (How to Choose the Right Grade of CMC Powder? [online] Tenessy [retrieved on 08/28/2026]. Retrieved from the Internet: <https://tenessy.com/how-to-choose-the-right-grade-of-cmc-powder/) and SigmaAldrich (Carboxymethylcellulose sodium salt [online] SigmaAldrich [retrieved on 08/28/2026]. Retrieved from the Internet: [https://www.sigmaaldrich.com/US/en/product/sigma/c5678?srsltid=AfmBOoqqDGAgntY3TJtnnYNfZxlj3F-mfWC4doa0rhnL_7idoMI7v0MI).
Tenessy define low viscosity CMC as CMC with a viscosity of 25-100 cP at 2% concentration in water at 25C (Tenessy p1). SigmaAldrich define low viscosity CMC as CMC with a viscosity of 25-200 cP at 2% in water at 25C.
Therefore one of ordinary skill in the art would not be appraised of the meets and bounds of the claim limitations for “high viscosity grade”, “medium viscosity grade” and “low viscosity grade”.
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.
Claims 1, 3, 13, 15, 48, 56-57 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over: Kim et al (Eur J Pharm Biopharm (2015) 95:0 0;1-24; “Formulation to target delivery to the ciliary body and choroid via the suprachoroidal space of the eye using microneedles”) and Ding et al (JCI (2019) 128:11;1-12; “AAV8-vectored suprachoroidal gene transfer produces widespread ocular transgene expression”, as cited in the IDS filed 01/16/2024); and as evidenced by SigmaAldrich (https://www.sigmaaldrich.com/US/en/product/sigma/c5013?srsltid=AfmBOoox5gxdRZDvKYKeMggg0lhI8zsIPUK_yy_DQfRzIY6_LizmVIe3) and by Alfa Chemistry (CAS 9004-32-4 Sodium carboxymethyl cellulose, average Mw ~700 kDa - Colloidal Materials / Alfa Chhttps://colloid.alfa-chemistry.com/product/sodium-carboxymethyl-cellulose-average-mw-cas-9004-32-4-362451.htmlemistry).
Regarding claims 1, 13, 15: The claims recite “about”. The instant specification defines the term “about” as “plus or minus 10% of a given value or range” (p84 [00153]).
As discussed supra, the claim is drawn to a pharmaceutical composition suitable for administration to the SCS of a human subject. The phrases “pharmaceutical” and “suitable for administration” are considered intended use and do not impose or imply a structural limitation to the claimed product.
Kim teach that a challenge for ophthalmic drug deliver is enabling drugs to effectively or selectively reach the site of pharmacological action in the eye (p2 ¶1). Kim teach the suprachoroidal space represents a promising site of drug administration for ocular diseases (p2 ¶1).
Kim teach compositions with viscosity of ~60-70 Pa-s at a shear rate of 0.1 s-1 (Discovisc and Hyaluronic acid) (Fig 3). A shear rate of 0.1 s-1 reads on a shear rate of at most about 1 s-1, as required by the claim.
The viscosity reported by Kim in Pa-s can be converted to centipoise units (as used in the instant claims) using the conversion 1 Pa-s = 1000 cp (as evidenced by Unit converters.net). 60-70 Pa-s at a shear rate of 0.1 s-1 as disclosed by Fig 3 of Kim is about 60,000 – 70,000 cP, which lies within the claimed range of 25-3,000,000 cP at a shear rate of at most s-1 and the claimed range of claim 15 a); between about 25cP to about 100,000 cP at a shear rate of at most about 1 s-1.
MPEP 2131.03 reads “"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated' if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”.
Thus the disclosure of Kim is considered to meet the viscosity range of between the range about 25 cP to about 3x106 cP as measured at a shear rate of at most about 1 s-1, as required by the instant claim.
Kim further teach the formulations comprise particles to provide information about how to deliver targeted drug particles within the suprachoroidal space (p3 ¶4).
Kim do not teach that the particles comprise an AAV vector comprising an expression cassette encoding a transgene.
Ding teach suprachoroidal injection of AAV8.GFP in rats which delivers the transgene GFP (p3 col2 ¶2). GFP is expressed in the retina and thus the AAV8.GFP vector comprises an expression cassette encoding the transgene (Fig 1B).
Thus the disclosure of Ding reads on a pharmaceutical composition suitable for administration to the suprachoroidal space of the eye wherein the composition comprises a recombinant AAV vector comprising an expression cassette encoding a transgene as required by the instant claim.
It would have been obvious to one of ordinary skill in the art to modify the composition of Kim, drawn to a composition with a viscosity of between about 25cP to about 3x106 cP as measured at a shear rate of at most about 1 s-1 which comprises particles that mimic drug delivery to the suprachoroidal space of the eye, with the teachings of Ding, to use a recombinant AAV vector comprising an expression cassette encoding a transgene in place of the non-drug particles.
One of ordinary skill in the art would have been motivated to modify the composition of Kim by using an AAV vector comprising an expression cassette encoding a transgene in place of non-drug particles because Kim teach the non-drug particles are used to inform about drug delivery and Kim further teach suprachoroidal injection is a new route for ocular drug delivery (p3 col1 ¶2). One would be further motivated because Ding teach gene delivery of therapeutic proteins has the potential to revolutionize the management of millions of patients with common retinal and choroidal diseases (p9 col1 ¶2). Ding further teach that the AAV vector efficiently transduces a wide variety of cell types and demonstrate proof-of-concept for delivery of a transgene using suprachoroidal injection of AAV vectors (p9 col1 ¶3).
One would have had a reasonable expectation of success because both disclosures are drawn to delivery of particles which represent drug therapies to the suprachoroidal space of the eye.
Regarding claim 3: The claim is drawn to the alternatives a.- f.. Alternative c. requires the thickness at a site of injection after suprachoroidal administration of the composition of claim 1 compared to a reference composition.
The thickness of the site after injection is considered a property of the use of composition, but does not impart further structure on the claimed composition of claim 1. A reference solution does not impart or imply structure to the claimed composition.
Thus any composition which meets the structural requirements of the composition of claim 1 is considered to also have the properties (or intended result) required by claim 3.
Regarding claim 48: The claim limitation is drawn to the intended use of the claimed composition; the human subject diagnosed with a specific disease for which the composition is suitable for administration, and thus does not impose or imply a structural limitation to the claimed product.
Regarding claim 56: The claim recites vector genome concentration (VGC) of the vector in units of GC/mL. The instant specification teaches genome copies per ml is (GC/mL) (p79 [00148]). The instant specification also teaches “about” means within plus or minus 10% of a given value or range (p84 [00155]).
The teachings of Kim and Ding are discussed supra. Kim do not teach a vector genome concentration of 4.0 x 1010 genome copies/mL.
Ding teach 3 ul containing 1.2 x 108 genome copies were injected, which is a genome copy concentration of 4.0 x 1010 genome copies/mL (p10 col2 ¶1).
It would have been obvious to one of ordinary skill in the art to modify the composition of Kim, drawn to a composition with a viscosity of between about 25cP to about 3x106 cP as measured at a shear rate of at most about 1 s-1 which comprises particles that mimic drug delivery to the suprachoroidal space of the eye, with the teachings of Ding, to use 4.0 x 1010 genome copies/mL of a recombinant AAV vector comprising an expression cassette encoding a transgene in place of the non-drug particles.
One of ordinary skill in the art would have been motivated to modify the composition of Kim by using 4.0 x 1010 genome copies/mL of an AAV vector comprising an expression cassette encoding a transgene in place of non-drug particles because Kim teach the non-drug particles are used to inform about drug delivery and Kim further teach suprachoroidal injection is a new route for ocular drug delivery (p3 col1 ¶2). One would be further motivated because Ding teach gene delivery of therapeutic proteins has the potential to revolutionize the management of millions of patients with common retinal and choroidal diseases (p9 col1 ¶2). Ding further teach that the AAV vector efficiently transduces a wide variety of cell types and demonstrate proof-of-concept for delivery of a transgene using suprachoroidal injection of AAV vectors (p9 col1 ¶3). One would have also been motivated because Ding teach injection of 4.0 x 1010 genome copies/mL of the vector provides widespread transgene expression (p5 col1 ¶2).
One would have had a reasonable expectation of success because both disclosures are drawn to delivery of particles which represent drug therapies to the suprachoroidal space of the eye.
Regarding claim 57: The claim recites the wherein clause “wherein the total number of genome copies of the recombinant AAV vector to be
administered is about 6.0 x 1010 genome copies”. The wherein clause is drawn to a method of using the composition and does not impart or imply structure to the claimed composition.
Regarding claim 63: The claim is drawn to a reference pharmaceutical composition and thus does not imply or impart structure on the claimed composition.
Regarding claim 65: The teachings of Kim and Ding are discussed supra. Kim also teach carboxymethyl cellulose for use in the pharmaceutical composition is 700 kDa (p9 ¶2). Kim teach CMC is used at a concentration of 1.7% (p10 ¶5). This reads on 0.2-15% carboxymethyl cellulose as required by the claim.
While Kim are silent on the specific viscosity grade of the CMC, as discussed below, the CMC used by Kim is considered high viscosity grade, absent evidence to the contrary.
As evidenced by Alfa Chemistry, CMC with a molecular weight of 700 kDa is high viscosity grade (p1 feature: high viscosity) and thus the disclosure of Kim is considered to read on high viscosity grade, as required by the claim absent evidence to the contrary.
Regarding claim 72: The claim is dependent on claim 1, which requires a viscosity of between about 25 cP to about 3 x 106 cP as measured at a shear rate of at most about 1 s-1.
Claim 72 does not impart or imply additional structural limitations to the claimed composition, thus any composition that reads on claim 1 is also considered to read on the instant claim.
Claims 18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al and Ding et al as applied to claim 1 above, and further in view of Im et al (US 10,646,546 B2; 2020).
Regarding claims 18, 20-21: The teachings of Kim and Ding are discussed supra. Kim and Ding do not teach the composition comprises 6% sucrose.
Im teach an ophthalmic pharmaceutical composition comprising a therapeutically effective amount of drug for intravitreal and intraocular administration (p4 col 3 ln25-25). Im teach the sucrose concentration controls the tonicity of the composition and that compositions with sucrose have excellent stability (p4 col3 ln 19-21; p4 col4 ln 10-20). Im further the sucrose concentration is 6-8% (Im claims 1 and 4).
MPEP 2131.03 reads “When the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, a case by case determination must be made as to anticipation. In order to anticipate the claims, the claimed subject matter must be disclosed in the reference with ‘sufficient specificity to constitute an anticipation under the statute.' ”
In the case of the instant claim, the range disclosed by the prior art clearly overlaps with the claimed values. In the in the absence of new or unexpected results for values outside the claimed range, the range disclosed by the cited Art is considered to disclose the claimed range with “sufficient specificity” to render obvious the claimed concentration.
It would have been obvious to modify the composition taught by Kim, and Ding with the teachings of Im, to include 6% sucrose in the composition.
One would have been motivated to modify the composition of Kim and Ding by using 6% sucrose in the composition because Im teach sucrose is used to adjust tonicity without using an ionic tonicity agent such as NaCl and that the composition has excellent stability (p4 col3 ln18-22).
One would have had a reasonable expectation of success because the compositions of Kim, Ding and Im are drawn to delivering intraocular therapies to the eye by injection.
Claim 80 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al and Ding et al as applied to claim 1 above, and further in view of AAT Bioquest (AAT Bioquest [online]. [retrieved on 7/22/2026]. Retrieved from the internet > https://www.aatbio.com/resources/faq-frequently-asked-questions/What-is-the-difference-between-PBS-and-dPBS).
Regarding claim 80: The teachings of Kim and Ding are discussed supra. While Ding teach a PBS based buffer, Ding are silent on if the PBS is a modified Dulbecco’s phosphate-buffered saline solution (dPBS).
AAT Bioquest teach PBS and dPBS are well-known buffer solutions that are used in biological research to maintain a consistent pH (between 7.2-7.6) (p1 ¶1/2). AAT Bioquest further teach the essential properties of both PBS and dPBS are that ion concentrations and osmolarity retain their isotonic properties so that the solutions are compatible with the human body (p2 ¶1). AAT Bioquest also teach that multiple formulations exist and that the solutions can often be used interchangeably (p3 ¶1).
It would have been obvious for one of ordinary skill in the art to modify the disclosure of Ding to use a modified dPBS based buffer in place of a PBS based buffer because ATT Bioquest teach both buffers are well known solutions that have the same essential properties to be compatible with the human body, and that multiple formulations (modified formulations) exist and that they can often be used interchangeably.
There would have been a reasonable expectation that the modified dPBS and PBS would work equivalently in the PBS based buffer of Ding, and the results would have been predictable because both buffers are well known solutions that have the same essential properties to be compatible with the human body, and multiple formulations exist and can often be used interchangeably.
Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al and Ding et al as applied to claim 1 above, and further in view of AAT Bioquest (AAT Bioquest [online]. [retrieved on 7/22/2026]. Retrieved from the internet > https://www.aatbio.com/resources/faq-frequently-asked-questions/What-is-the-difference-between-PBS-and-dPBS) and Im et al (US 10,646,546 B2), and as evidenced by by ThermoFisher (dPBS [online]. ThermoFisher [retrieved on 7/22/2026]. Retrieved from the internet: <https://www.thermofisher.com/us/en/home/technical-resources/media-formulation.149.html US).
Regarding claim 81: The teachings of Kim and Ding are discussed supra.
Regarding potassium chloride, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic: While Ding teach a PBS based buffer, Kim and Ding do not teach the composition comprises potassium chloride, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic.
AAT Bioquest teach PBS and dPBS are well-known buffer solutions that are used in biological research to maintain a consistent pH (between 7.2-7.6) (p1 ¶1/2). AAT Bioquest further teach the essential properties of both PBS and dPBS are that ion concentrations and osmolarity retain their isotonic properties so that the solutions are compatible with the human body (p2 ¶1). AAT Bioquest also teach that multiple formulations exist and that the solutions can often be used interchangeably (p3 ¶1).
As evidenced by Thermofisher, dPBS comprises potassium chloride, potassium phosphate monobasic, sodium chloride, and sodium phosphate dibasic (Thermofisher p1).
It would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to use a modified dPBS based buffer in place of a PBS based buffer as taught by AAT Bioquest because ATT Bioquest teach both buffers are well known solutions that have the same essential properties to be compatible with the human body, and that multiple formulations (modified formulations) exist and that they can often be used interchangeably.
There would have been a reasonable expectation that the modified dPBS and PBS would work equivalently in the PBS based buffer of Ding, and the results would have been predictable because both buffers are well known solutions that have the same essential properties to be compatible with the human body, and multiple formulations exist and can often be used interchangeably.
Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Regarding sucrose: The Kim and Ding do not teach that the composition comprises sucrose.
Im teach an ophthalmic pharmaceutical composition comprising a therapeutically effective amount of drug for intravitreal and intraocular administration (p4 col 3 ln25-25). Im teach the sucrose concentration controls the tonicity of the composition and that compositions with sucrose have excellent stability (p4 col3 ln 19-21; p4 col4 ln 10-20).
It also would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to include sucrose as a tonicity agent as taught by Im. One would have been motivated to include sucrose as a tonicity agent because Im teach such compositions have excellent stability.
There would have been a reasonable expectation of success for including sucrose in the composition of Kim and Ding as taught by Im because the compositions of Kim, Ding and Im are drawn to delivering intraocular therapies to the eye by injection.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al and Ding et al as applied to claim 1 above, and further in view of AAT Bioquest (AAT Bioquest [online]. [retrieved on 7/22/2026]. Retrieved from the internet > https://www.aatbio.com/resources/faq-frequently-asked-questions/What-is-the-difference-between-PBS-and-dPBS), Furfine et al (US 11,066,458 B2; published 2020), Sigle et al (WO 2019/020777 A1), Im et al (US 10,646,546 B2), and Rodrigues (Pharm Res (2019) 36:29;1-20; “Pharmaceutical Development of AAV-Based Gene Therapy Products for the Eye”); and as evidenced by ThermoFisher (dPBS [online]. ThermoFisher [retrieved on 7/22/2026]. Retrieved from the internet: <https://www.thermofisher.com/us/en/home/technical-resources/media-formulation.149.html US).
Regarding claim 82: The teachings of Kim and Ding are discussed supra.
Regarding 2.70 mmol/L potassium chloride, about 1.47 mmol/L potassium phosphate monobasic, about 100 mmol/L sodium chloride, about 8.10 mmol/L sodium phosphate dibasic: While Ding teach a PBS based buffer, Kim and Ding do not teach the composition comprises about 2.70 mmol/L potassium chloride, about 1.47 mmol/L potassium phosphate monobasic, about 100 mmol/L sodium chloride, about 8.10 mmol/L sodium phosphate dibasic, and about 117 mmol/L sucrose.
AAT Bioquest teach PBS and dPBS are well-known buffer solutions that are used in biological research to maintain a consistent pH (between 7.2-7.6) (p1 ¶1/2). AAT Bioquest further teach the essential properties of both PBS and dPBS are that ion concentrations and osmolarity retain their isotonic properties so that the solutions are compatible with the human body (p2 ¶1). AAT Bioquest also teach that multiple formulations exist and that the solutions can often be used interchangeably (p3 ¶1).
As evidenced by ThermoFisher, dPBS comprises 2.7 mM potassium chloride, 1.5 mM potassium phosphate monobasic, 137.9 mM sodium chloride, and 8.1 mM sodium phosphate dibasic (Thermofisher p1).
It would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to use a modified dPBS based buffer in place of a PBS based buffer as taught by AAT Bioquest because ATT Bioquest teach both buffers are well known solutions that have the same essential properties to be compatible with the human body, and that multiple formulations (modified formulations) exist and that they can often be used interchangeably.
It would have been further obvious to modify the dPBS to comprise 100mM NaCl in place of the 137.9 mM sodium chloride as taught by ThermoFisher because AAT bioquest teach multiple formulations of PBS and dPBS exist and Furfine (US 11,066,458; filed 2019) teach ophthalmic formulations comprising 40-135 mM of sodium chloride, which is used as a tonicity agents (col 2 ln 20-25; ln 25-30, ln 40-45).
There would have been a reasonable expectation that the modified dPBS with 100 mM sodium chloride would work equivalently in the PBS based buffer of Ding, and the results would have been predictable because both buffers are well known solutions that have the same essential properties to be compatible with the human body, and multiple formulations exist and can often be used interchangeably and Furfine teach ophthalmic formulations comprising NaCl as a tonicity agent.
Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Regarding 117 mol/L sucrose: A composition comprising about 117 mmol/L sucrose is equivalent to a composition comprising a sucrose concentration of 4%.
Kim and Ding do not teach the composition comprises 4% sucrose.
Sigl teach a pharmaceutical composition for injection into the eye (abstract). Sigle compositions comprising sucrose at concentrations of 3-20% w/v (p5 ln20-25).
MPEP 2131.03 reads “When the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, a case by case determination must be made as to anticipation. In order to anticipate the claims, the claimed subject matter must be disclosed in the reference with ‘sufficient specificity to constitute an anticipation under the statute.' ”
MPEP 2131.03 further reads “If the prior art disclosure does not disclose a claimed range with "sufficient specificity" to anticipate a claimed invention, any evidence of unexpected results within the narrow range may render the claims nonobvious. See MPEP § 716.02 et seq.”.
In the case of the instant claim, the range disclosed by the prior art clearly overlaps with the claimed values. In the in the absence of new or unexpected results for values outside the claimed range, the range disclosed by the cited Art is considered to disclose the claimed range with “sufficient specificity” to render obvious the claimed concentration.
Im teach an ophthalmic pharmaceutical composition comprising a therapeutically effective amount of drug for intravitreal and intraocular administration (p4 col 3 ln25-25). Im teach the sucrose concentration controls the tonicity of the composition and that compositions with sucrose have excellent stability (p4 col3 ln 19-21; p4 col4 ln 10-20).
It would have been obvious to modify the composition taught by Kim, Ding and AAT Bioquest with the teachings of Sigle, to include sucrose in the pharmaceutical composition at 4% concentration.
One would have been motivated to modify the composition of Ding, Kim and AAT Bioquest by including 4% sucrose in the composition because Im teach sucrose is used to adjust tonicity without using an ionic tonicity agent such as NaCl and that the composition has excellent stability (p4 col3 ln18-22). Furthermore, Rodrigues teach carbohydrates such as sucrose are commonly used as lyo/cryo protectants for gene therapy products for the eye comprising AAV vectors (p11 col1 ¶3).
One would have had a reasonable expectation of success because the inventions are drawn to delivering intraocular therapies to the eye by injection.
Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al and Ding et al as applied to claim 1 above, and further in view AAT Bioquest (AAT Bioquest [online]. [retrieved on 7/22/2026]. Retrieved from the internet > https://www.aatbio.com/resources/faq-frequently-asked-questions/What-is-the-difference-between-PBS-and-dPBS), Im et al (US 10,646,546 B2), Luxturna data sheet (as cited in the IDS filed 01/16/2024), Rodrigues (Pharm Res (2019) 36:29;1-20; “Pharmaceutical Development of AAV-Based Gene Therapy Products for the Eye”) and as evidenced by Alfa Chemistry (CAS 9004-32-4 Sodium carboxymethyl cellulose, average Mw ~700 kDa - Colloidal Materials / Alfa Chhttps://colloid.alfa-chemistry.com/product/sodium-carboxymethyl-cellulose-average-mw-cas-9004-32-4-362451.htmlemistry) and ThermoFisher (dPBS [online]. ThermoFisher [retrieved on 7/22/2026]. Retrieved from the internet: <https://www.thermofisher.com/us/en/home/technical-resources/media-formulation.149.html US):
Regarding claim 83: The teachings of Kim and Ding are discussed supra.
Regarding potassium chloride, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic:
While Ding teach a PBS based buffer, Kim and Ding do not teach the composition comprises potassium chloride, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic.
AAT Bioquest teach PBS and dPBS are well-known buffer solutions that are used in biological research to maintain a consistent pH (between 7.2-7.6) (p1 ¶1/2). AAT Bioquest further teach the essential properties of both PBS and dPBS are that ion concentrations and osmolarity retain their isotonic properties so that the solutions are compatible with the human body (p2 ¶1). AAT Bioquest also teach that multiple formulations exist and that the solutions can often be used interchangeably (p3 ¶1).
As evidenced by Thermofisher, dPBS comprises potassium chloride, potassium phosphate monobasic, sodium chloride, and sodium phosphate dibasic (Thermofisher p1), thus modification of the buffer taught by .
It would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to use a modified dPBS based buffer in place of a PBS based buffer as taught by AAT Bioquest because ATT Bioquest teach both buffers are well known solutions that have the same essential properties to be compatible with the human body, and that multiple formulations (modified formulations) exist and that they can often be used interchangeably.
There would have been a reasonable expectation that the modified dPBS and PBS would work equivalently in the PBS based buffer of Ding, and the results would have been predictable because both buffers are well known solutions that have the same essential properties to be compatible with the human body, and multiple formulations exist and can often be used interchangeably.
Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Regarding sucrose: The teachings of Kim and Ding are discussed supra. Kim and Ding do not teach the composition comprises, sucrose.
Im teach an ophthalmic pharmaceutical composition comprising a therapeutically effective amount of drug for intravitreal and intraocular administration (p4 col 3 ln25-25). Im teach the sucrose concentration controls the tonicity of the composition and that compositions with sucrose have excellent stability (p4 col3 ln 19-21; p4 col4 ln 10-20).
It also would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to include sucrose as a tonicity agent as taught by Im. One would have been motivated to include sucrose as a tonicity agent because Im teach such compositions have excellent stability.
There would have been a reasonable expectation of success for including sucrose in the composition of Kim and Ding as taught by Im because the compositions of Kim, Ding and Im are drawn to intraocular therapies delivered to the eye by injection.
Regarding the surfactant poloxamer 188: The teachings of Kim and Ding do not teach the composition comprises poloxamer 188.
Luxturna is an AAV vector based gene therapy drug for subretinal injection which was approved for use in 2017 (Luxturna product notes p1). The formulation of Luxturna includes 0.001% poloxamer 188 as an excipient (p7 ¶11 Description).
It would have been obvious to modify composition taught by Kim and Ding with the teachings of Luxturna product notes, to include poloxamer 188 in the composition.
One would have been motivated to modify the composition of Kim and Ding to include poloxamer 188 as a pharmaceutical excipient as taught by the Luxturna product notes because Rodrigues teach that non-ionic surfactants such as poloxamers are commonly included in AAV formulations for gene therapy for the eye to minimize stresses due to exposure to different surfaces during manufacturing and to improve protein recovery at the point of use (p11 col1 ¶3).
One would have had a reasonable expectation of success because the disclosures are directed to compositions which deliver AAV therapies to the eye.
Regarding CMC high viscosity grade: The teachings of Kim and Ding are discussed supra. Kim also teach carboxymethyl cellulase for use in the pharmaceutical composition is 700 kDa (p9 ¶2). While Kim are silent on the specific viscosity grade of the CMC, as discussed below, the CMC used by Kim is considered high viscosity grade, absent evidence to the contrary.
As evidenced by Alfa Chemistry, CMC with a molecular weight of 700 kDa is high viscosity grade (p1 feature: high viscosity) and thus the disclosure of Kim is considered to read on high viscosity grade, as required by the claim.
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al and Ding et al as applied to claim 1 above, and further in view of AAT Bioquest (AAT Bioquest [online]. [retrieved on 7/22/2026]. Retrieved from the internet > https://www.aatbio.com/resources/faq-frequently-asked-questions/What-is-the-difference-between-PBS-and-dPBS), Im et al (US 10,646,546 B2), Chiang et al (IVOS (2017) 1-10; “Thickness and Closure Kinetics of the Suprachoroidal Space Following Microneedle Injection of Liquid Formulations”; as cited in the IDS filed 01/16/2024); and as evidenced by ThermoFisher (dPBS [online]. ThermoFisher [retrieved on 7/22/2026]. Retrieved from the internet: <https://www.thermofisher.com/us/en/home/technical-resources/media-formulation.149.html US) and Alfa Chemistry (CAS 9004-32-4 Sodium carboxymethyl cellulose, average Mw ~700 kDa - Colloidal Materials / Alfa Chhttps://colloid.alfa-chemistry.com/product/sodium-carboxymethyl-cellulose-average-mw-cas-9004-32-4-362451.htmlemistry):
Regarding claim 84: The teachings of Kim and Ding are discussed supra.
Regarding potassium chloride, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic: While Ding teach a PBS based buffer, Kim and Ding do not teach the composition comprises potassium chloride, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic.
AAT Bioquest teach PBS and dPBS are well-known buffer solutions that are used in biological research to maintain a consistent pH (between 7.2-7.6) (p1 ¶1/2). AAT Bioquest further teach the essential properties of both PBS and dPBS are that ion concentrations and osmolarity retain their isotonic properties so that the solutions are compatible with the human body (p2 ¶1). AAT Bioquest also teach that multiple formulations exist and that the solutions can often be used interchangeably (p3 ¶1).
As evidenced by Thermofisher, dPBS comprises potassium chloride, potassium phosphate monobasic, sodium chloride, and sodium phosphate dibasic (Thermofisher p1).
It would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to use a modified dPBS based buffer in place of a PBS based buffer as taught by AAT Bioquest because ATT Bioquest teach both buffers are well known solutions that have the same essential properties to be compatible with the human body, and that multiple formulations (modified formulations) exist and that they can often be used interchangeably.
There would have been a reasonable expectation that the modified dPBS and PBS would work equivalently in the PBS based buffer of Ding, and the results would have been predictable because both buffers are well known solutions that have the same essential properties to be compatible with the human body, and multiple formulations exist and can often be used interchangeably.
Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Regarding sucrose: The teachings of Kim and Ding are discussed supra. Kim and Ding do not teach the composition comprises, sucrose.
Im teach an ophthalmic pharmaceutical composition comprising a therapeutically effective amount of drug for intravitreal and intraocular administration (p4 col 3 ln25-25). Im teach the sucrose concentration controls the tonicity of the composition and that compositions with sucrose have excellent stability (p4 col3 ln 19-21; p4 col4 ln 10-20).
It also would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to include sucrose as a tonicity agent as taught by Im. One would have been motivated to include sucrose as a tonicity agent because Im teach such compositions have excellent stability.
There would have been a reasonable expectation of success for including sucrose in the composition of Kim and Ding as taught by Im the compositions of Kim, Ding and Im are drawn to intraocular therapies delivered to the eye by injection.
Regarding 1% CMC high viscosity grade: Kim also teach carboxymethyl cellulase for use in the pharmaceutical composition is 700 kDa at 1.7% (p9 ¶2; p10 ¶5). While Kim are silent on the specific viscosity grade of the CMC, as discussed below, the CMC used by Kim is considered high viscosity grade, absent evidence to the contrary.
As evidenced by Alfa Chemistry, CMC with a molecular weight of 700 kDa is high viscosity grade (p1 feature: high viscosity) and thus the disclosure of Kim is considered to read on high viscosity grade, as required by the claim.
While Kim teach a composition comprising high viscosity grade CMC at a concentration of 1.7%, Kim do not teach 1% CMC of high viscosity grade.
Chiang teach the suprachoroidal space is a drug delivery site which has high bioavailability for targeted tissues in posterior segment diseases and fast clearance by the choroidal vasculature (p1 col1 ¶1). Chiang teach injection of a composition comprising 1% CMC expands the SCS only at or near the injection site (p5 col1 ¶2). Chaing further teach CMC solutions are largely retained near the site of injection, probably due to high viscosity (p7 col2 ¶1).
It would have been obvious to modify the teaching of Kim drawn to a composition comprising 1.7% high viscosity grade CMC, with the teaching of Chaing, to use 1% CMC.
One would have been motivated to use 1% CMC in place of 1.7% CMC because Chaing teach 1% CMC solutions are largely retained near the site of injection, which one of ordinary skill in the art would recognize as advantageous for targeted drug delivery.
One would have had a reasonable expectation of success because the inventions are all drawn to drug administration to the suprachoroidal space.
Claim 85 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al and Ding et al as applied to claim 1 above, and further in view of AAT Bioquest (AAT Bioquest [online]. [retrieved on 7/22/2026]. Retrieved from the internet > https://www.aatbio.com/resources/faq-frequently-asked-questions/What-is-the-difference-between-PBS-and-dPBS), ThermoFisher (dPBS [online]. ThermoFisher [retrieved on 7/22/2026]. Retrieved from the internet: <https://www.thermofisher.com/us/en/home/technical-resources/media-formulation.149.html US), Im et al (US 10,646,546 B2), Luxturna data sheet (as cited in the IDS filed 01/16/2024), and Rodrigues et al (Pharm Res (2019) 36:29;1-20; “Pharmaceutical Development of AAV-Based Gene Therapy Products for the Eye”):
Regarding claim 85: The teachings of Kim and Ding are discussed supra.
Regarding potassium chloride, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic:
While Ding teach a PBS based buffer, Kim and Ding do not teach the composition comprises potassium chloride, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic.
AAT Bioquest teach PBS and dPBS are well-known buffer solutions that are used in biological research to maintain a consistent pH (between 7.2-7.6) (p1 ¶1/2). AAT Bioquest further teach the essential properties of both PBS and dPBS are that ion concentrations and osmolarity retain their isotonic properties so that the solutions are compatible with the human body (p2 ¶1). AAT Bioquest also teach that multiple formulations exist and that the solutions can often be used interchangeably (p3 ¶1).
As evidenced by Thermofisher, dPBS comprises potassium chloride, potassium phosphate monobasic, sodium chloride, and sodium phosphate dibasic (Thermofisher p1).
It would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to use a modified dPBS based buffer in place of a PBS based buffer as taught by AAT Bioquest because ATT Bioquest teach both buffers are well known solutions that have the same essential properties to be compatible with the human body, and that multiple formulations (modified formulations) exist and that they can often be used interchangeably.
There would have been a reasonable expectation that the modified dPBS and PBS would work equivalently in the PBS based buffer of Ding, and the results would have been predictable because both buffers are well known solutions that have the same essential properties to be compatible with the human body, and multiple formulations exist and can often be used interchangeably.
Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Regarding sucrose: The teachings of Kim and Ding are discussed supra. Kim and Ding do not teach the composition comprises, sucrose.
Im teach an ophthalmic pharmaceutical composition comprising a therapeutically effective amount of drug for intravitreal and intraocular administration (p4 col 3 ln25-25). Im teach the sucrose concentration controls the tonicity of the composition and that compositions with sucrose have excellent stability (p4 col3 ln 19-21; p4 col4 ln 10-20).
It also would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to include sucrose as a tonicity agent as taught by Im. One would have been motivated to include sucrose as a tonicity agent because Im teach such compositions have excellent stability.
There would have been a reasonable expectation of success for including sucrose in the composition of Kim and Ding as taught by Im the compositions of Kim, Ding and Im are drawn to intraocular therapies delivered to the eye by injection.
Regarding the surfactant poloxamer 188: Kim and Ding do not teach the composition comprises poloxamer 188.
Luxturna is an AAV vector based gene therapy drug for subretinal injection which was approved for use in 2017 (Luxturna product notes p1). The formulation of Luxturna includes poloxamer 188 as an excipient (p7 ¶11 Description).
It would have been obvious to modify composition taught by Kim and Ding with the teachings of Luxturna product notes, to include poloxamer 188 in the composition.
One would have been motivated to modify the composition of Kim and Ding to include poloxamer 188 as a pharmaceutical excipient as taught by the Luxturna product notes because Rodrigues teach that non-ionic surfactants such as poloxamers are commonly included in AAV formulations for gene therapy for the eye to minimize stresses due to exposure to different surfaces during manufacturing and to improve protein recovery at the point of use (p11 col1 ¶3).
One would have had a reasonable expectation of success because the disclosures are directed to compositions which deliver AAV therapies to the eye.
Regarding CMC: The teachings of Kim and Ding are discussed supra.
Kim teach the composition comprises carboxymethyl cellulase (CMC) (p9 ¶2).
Claim 86 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al and Ding et al as applied to claim 1 above, and further in view of AAT Bioquest (AAT Bioquest [online]. [retrieved on 7/22/2026]. Retrieved from the internet > https://www.aatbio.com/resources/faq-frequently-asked-questions/What-is-the-difference-between-PBS-and-dPBS), Furfine et al (US 11,066,458 B2; published 2020), Sigle et al (WO 2019/020777 A1), Im et al (US 10,646,546 B2), Rodrigues et al (Pharm Res (2019) 36:29;1-20; “Pharmaceutical Development of AAV-Based Gene Therapy Products for the Eye”), Luxturna data sheet (as cited in the IDS filed 01/16/2024), and Chiang et al (IVOS (2017) 1-10; “Thickness and Closure Kinetics of the Suprachoroidal Space Following Microneedle Injection of Liquid Formulations”; as cited in the IDS filed 01/16/2024); and as evidenced by ThermoFisher (dPBS [online]. ThermoFisher [retrieved on 7/22/2026]. Retrieved from the internet: <https://www.thermofisher.com/us/en/home/technical-resources/media-formulation.149.html US) and Alfa Chemistry (CAS 9004-32-4 Sodium carboxymethyl cellulose, average Mw ~700 kDa - Colloidal Materials / Alfa Chhttps://colloid.alfa-chemistry.com/product/sodium-carboxymethyl-cellulose-average-mw-cas-9004-32-4-362451.htmlemistry):
Regarding claim 86: The teachings of Kim and Ding are discussed above.
Regarding 2.70 mmol/L potassium chloride, about 1.47 mmol/L potassium phosphate monobasic, about 100 mmol/L sodium chloride, about 8.10 mmol/L sodium phosphate dibasic:
While Ding teach a PBS based buffer, Kim and Ding do not teach the composition comprises about 2.70 mmol/L potassium chloride, about 1.47 mmol/L potassium phosphate monobasic, about 100 mmol/L sodium chloride, and about 8.10 mmol/L sodium phosphate.
As evidenced by ThermoFisher, dPBS comprises 2.7 mM potassium chloride, 1.5 mM potassium phosphate monobasic, 137.9 mM sodium chloride, and 8.1 mM sodium phosphate dibasic (Thermofisher p1).
AAT Bioquest teach PBS and dPBS are well-known buffer solutions that are used in biological research to maintain a consistent pH (between 7.2-7.6) (p1 ¶1/2). AAT Bioquest further teach the essential properties of both PBS and dPBS are that ion concentrations and osmolarity retain their isotonic properties so that the solutions are compatible with the human body (p2 ¶1). AAT Bioquest also teach that multiple formulations exist and that the solutions can often be used interchangeably (p3 ¶1).
It would have been obvious for one of ordinary skill in the art to modify the composition of Kim and Ding to use a modified dPBS based buffer in place of a PBS based buffer as taught by AAT Bioquest because ATT Bioquest teach both buffers are well known solutions that have the same essential properties to be compatible with the human body, and that multiple formulations (modified formulations) exist and that they can often be used interchangeably.
It would have been further obvious to modify the dPBS to comprise 100mM NaCl in place of the 137.9 mM sodium chloride as taught by ThermoFisher because AAT bioquest teach multiple formulations of PBS and dPBS exist and Furfine (US 11,066,458; filed 2019) teach ophthalmic formulations comprising 40-135 mM of sodium chloride, which is used as a tonicity agents (col 2 ln 20-25; ln 25-30, ln 40-45).
There would have been a reasonable expectation that the modified dPBS with 100 mM sodium chloride would work equivalently in the PBS based buffer of Ding, and the results would have been predictable because both buffers are well known solutions that have the same essential properties to be compatible with the human body, and multiple formulations exist and can often be used interchangeably and Furfine teach ophthalmic formulations comprising NaCl as a tonicity agent.
Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered to be obvious. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Regarding 117 mmol/L sucrose: A composition comprising about 117 mmol/L sucrose is equivalent to a composition comprising a sucrose concentration of 4%.
Kim and Ding do not teach the composition comprises 4% sucrose.
Sigl teach a pharmaceutical composition for injection into the eye (abstract). Sigle compositions comprising sucrose at concentrations of 3-20% w/v (p5 ln20-25).
MPEP 2131.03 reads “When the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, a case by case determination must be made as to anticipation. In order to anticipate the claims, the claimed subject matter must be disclosed in the reference with ‘sufficient specificity to constitute an anticipation under the statute.' ”
MPEP 2131.03 further reads “If the prior art disclosure does not disclose a claimed range with "sufficient specificity" to anticipate a claimed invention, any evidence of unexpected results within the narrow range may render the claims nonobvious. See MPEP § 716.02 et seq.”.
In the case of the instant claim, the range disclosed by the prior art clearly overlaps with the claimed values. In the in the absence of new or unexpected results for values outside the claimed range, the range disclosed by the cited Art is considered to disclose the claimed range with “sufficient specificity” to render obvious the claimed concentration.
Im teach an ophthalmic pharmaceutical composition comprising a therapeutically effective amount of drug for intravitreal and intraocular administration (p4 col 3 ln25-25). Im teach the sucrose concentration controls the tonicity of the composition and that compositions with sucrose have excellent stability (p4 col3 ln 19-21; p4 col4 ln 10-20).
It would have been obvious to modify the composition taught by Kim, Ding and AAT Bioquest with the teachings of Sigle, to include sucrose in the pharmaceutical composition at 4% concentration.
One would have been motivated to modify the composition of Ding, Kim and AAT Bioquest by including 4% sucrose in the composition because Im teach sucrose is used to adjust tonicity without using an ionic tonicity agent such as NaCl and that the composition has excellent stability (p4 col3 ln18-22). Furthermore, Rodrigues teach carbohydrates such as sucrose are commonly used as lyo/cryo protectants for gene therapy products for the eye comprising AAV vectors (p11 col1 ¶3).
One would have had a reasonable expectation of success the compositions of Kim, Ding and Im are drawn to intraocular therapies delivered to the eye by injection.
Regarding 0.001% poloxamer 188: Kim and Ding do not teach the composition comprises 0.001% poloxamer 188.
Luxturna is an AAV vector based gene therapy drug for subretinal injection which was approved for use in 2017 (Luxturna product notes p1). The formulation of Luxturna includes 0.001% poloxamer 188 as an excipient (p7 ¶11 Description).
It would have been obvious to modify composition taught by Kim and Ding with the teachings of Luxturna product notes, to include poloxamer 188 in the composition.
One would have been motivated to modify the composition of Kim and Ding to include poloxamer 188 as a pharmaceutical excipient as taught by the Luxturna product notes because Rodrigues teach that non-ionic surfactants such as poloxamers are commonly included in AAV formulations for gene therapy for the eye to minimize stresses due to exposure to different surfaces during manufacturing and to improve protein recovery at the point of use (p11 col1 ¶3).
One would have had a reasonable expectation of success because the disclosures are directed to compositions which deliver AAV therapies to the eye.
Regarding 1% CMC high viscosity grade: Kim also teach carboxymethyl cellulase for use in the pharmaceutical composition is 700 kDa at 1.7% (p9 ¶2; p10 ¶5). While Kim are silent on the specific viscosity grade of the CMC, as discussed below, the CMC used by Kim is considered high viscosity grade, absent evidence to the contrary.
As evidenced by Alfa Chemistry, CMC with a molecular weight of 700 kDa is high viscosity grade (p1 feature: high viscosity) and thus the disclosure of Kim is considered to read on high viscosity grade, as required by the claim.
As evidenced by Alfa Chemistry, CMC with a molecular weight of 700 kDa is high viscosity grade (p1 feature: high viscosity) and thus the disclosure of Kim is considered to read on high viscosity grade, as required by the claim.
While Kim teach a composition comprising high viscosity grade CMC at a concentration of 1.7%, Kim do not teach 1% CMC of high viscosity grade.
Chiang teach the suprachoroidal space is a drug delivery site which has high bioavailability for targeted tissues in posterior segment diseases and fast clearance by the choroidal vasculature (p1 col1 ¶1). Chiang teach injection of a composition comprising 1% CMC expands the SCS only at or near the injection site (p5 col1 ¶2). Chaing further teach CMC solutions are largely retained near the site of injection, probably due to high viscosity (p7 col2 ¶1).
It would have been obvious to modify the teaching of Kim drawn to a composition comprising 1.7% high viscosity grade CMC, with the teaching of Chaing, to use 1% CMC.
One would have been motivated to use 1% CMC in place of 1.7% CMC because Chaing teach 1% CMC solutions are largely retained near the site of injection, which one of ordinary skill in the art would recognize as advantageous for targeted drug delivery.
One would have had a reasonable expectation of success because the inventions are all drawn to drug administration to the suprachoroidal space.
Conclusion
No claims are allowed.
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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/TAEYOON KIM/Primary Examiner, Art Unit 1631
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