DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-2, 4-6, 8, 16, 31-40, 42, 44-45, 47-48, 50, 52-53, 56-58, 62, and 64-72 are pending.
Applicant is advised that should claim 48 be found allowable, claim 50 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Objections
Claim 62 is objected to because of the following informalities: the claims states “complications of diabetic”, but it is believed that Applicant intended to state “complications of diabetic retinopathy”. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 10 February 2025 and 13 January 2026 were filed before the mailing of a non-final Office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 2, 4-6, 8, 45, 52-53, 56-57, 66 and 68-71 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
claim 2 recites the broad recitation “one or more rifamycin compounds is selected from the group consisting of rifamycin SV, 3-formyl rifamycin SV, rifampicin, rifabutin, rifapentine, and rifaximin”, and the claim also recites “optionally the one or more rifamycin compounds is rifampicin” which is the narrower statement of the range/limitation;
claim 6 recites the broad recitation “one or more viscosity imparting agents is selected from the group consisting of: petrolatum, liquid paraffin, light liquid paraffin, castor oil,… and cellulosic polymers”, and the claim also recites “optionally the one or more viscosity imparting agents is petrolatum, liquid paraffin, light liquid paraffin, sesame oil, or cellulose polymers” which is the narrower statement of the range/limitation;
claim 8 recites the broad recitation “at least about 100 mPaS to at least about 200 mPaS at 25°C”, and the claim also recites “or optionally about 100 mPaS, or about 150 mPaS, or about 160 mPaS, or about 170 mPaS, or about 180 mPaS, or about 190 mPaS, or about 200 mPaS, at 25°C” which is the narrower statement of the range/limitation;
claims 45 and 66 recite the broad recitation “delivery of the one or more rifamycin compounds to the sub-retina, sclera, retina, and/or vitreous tissue”, and the claims also recite “optionally to the sub-retina and sclera” which is the narrower statement of the range/limitation;
claim 68 also recites the broad recitation “at least a 5-fold… reduction in plasma exposure”, and the claim also recites “optionally results in at least about 100-fold reduction in plasma exposure” which is the narrower statement of the range/limitation;
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 4 and 8, the recitation of “to at least” is indefinite because the claims recite ranges but the ranges do not contain an upper limit. The recitation of “at least” implies that the value can be greater than the recited value. Therefore, it is unclear what the upper limit is for the ranges reciting “to at least”.
Regarding claim 5, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 52 and 69, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “disease” in claims 52 and 69 is used by the claim to include “glaucoma surgery, cicatrization, and brain damage,” while the accepted meaning is “a condition of the living animal or plant body or of one of its parts that impairs normal functioning and is typically manifested by distinguishing signs and symptoms.” The term is indefinite because the specification does not clearly redefine the term.
Regarding claims 53 and 70, it is also unclear if Applicant is stating that AMD is a separate disease from dry AMD and wet AMD, when dry AMD and wet AMD are the two types of AMD.
Claims 56-57 and 71 depend from claims 53 and 70 but they do not clarify whether AMD is a separate disease from dry AMD and wet AMD.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 recites “a final viscosity of at least about 0 mPaS”, but claim 1 states that the ophthalmic composition has “a viscosity of at least 1 mPaS at 25 °C”. Therefore, claim 8 recites a final viscosity that is outside the range of claim 1. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 8, 16, 31-33, 45, 48, 50, 52, 66, and 68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferrari (US 2008/0213188 A1).
Regarding claims 1-2, 5 and 8, Ferrari discloses a rifampicin eye-drop formulation comprising rifampicin, citric acid and boric acid ([0035]; Example 1).
Regarding the viscosity, it is noted that the viscosity of water at 25 °C is approximately 1 mPaS, and the composition according to Ferrari is predominantly water. Therefore, in the absence of evidence to the contrary, the viscosity of the formulation according to Ferrari will be at least 1 mPaS at 25 °C.
Regarding claims 4 and 16, Ferrari discloses a 10 ml formulation comprising 0.02 g rifampicin (i.e., 0.2% rifampicin w/w) (Example 1).
Regarding claim 16, the eye-drop formulation according to Ferrari does not comprise a viscosity imparting agent (Example 1).
Regarding claim 31, Ferrari discloses an eye-drop formulation (Example 1). Ferrari discloses that eye-drop solutions are applied to the eye (i.e., topically administered to the eye) ([0032]).
Regarding claim 33, Ferrari discloses one to two drops (or more if directed by a physician) are dropped two to three times a day, or as needed, into the eye ([0032]).
Regarding claims 45 and 66, Ferrari discloses administering the eye-drop solution comprising rifampicin to the eye, which would inherently deliver the rifampicin to the sub-retina, sclera, retina, and/or vitreous tissues.
Regarding claims 48, 50 and 68, Ferrari discloses administration of an eye-drop solution comprising the same components as instantly claimed. Therefore, in the absence of evidence to the contrary, the eye-drop solution of Ferrari will inherently result in at least about a 5-fold reduction in plasma exposure of the rifampicin relative to oral dosing at 300 mg.
Regarding claims 32 and 52, Ferrari discloses that the inventive ophthalmic solution can be used to treat dry eye conditions and eye inflammation, for example, ulcerative herpetic kerititis, in humans and animals ([0032]).
Claims 1, 2, 4-6, 8, 16, 31-40, 42, 44-45, 47-48, 50, 64-68, 69 and 72 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serizawa (US 2017/0202850 A1).
Regarding claims 1-2 and 8, Serizawa discloses a composition comprising rifampicin and a buffer (Tables 1-3). Serizawa further discloses that in some embodiments the compositions, including ophthalmic compositions may further comprise one or more viscosity imparting agents. In some embodiments, viscosity imparting agents increase the viscosity of ophthalmic solution and suspension. In some embodiments, viscosity imparting agents increase ocular contact time, thereby decreasing the drainage rate. In some embodiments, viscosity imparting agents increase mucoadhesion, ocular bioavailability and/or impart a lubricating effect. Examples of suitable viscosity imparting agents include, but are not limited to, carboxyvinyl polymer (e.g., Carbopol 934P or 974P), cellulosic polymers (e.g., carboxymethyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose or the like), polysaccharides (e.g., xanthan gum), polyvinyl pyrrolidone, polyvinyl alcohol, and combinations thereof. In some embodiments, the ophthalmic composition comprises about 0.01 wt %-20 wt %, about 0.1 wt %-15 wt %, about 0.15 wt %-10 wt %, about 0.2 wt %-5 wt %, about 0.25 wt %-3 wt %, about 0.3 wt %-2 wt %, about 0.1 wt %-20 wt %, about 1 wt %-10 wt %, about 2 wt %-10 wt %, about 2 wt %-8 wt %, about 2 wt %-5 wt %, about 5 wt %-10 wt %, about 5 wt %-20 wt % of viscosity imparting agent. In some embodiments, the ophthalmic composition comprises about 0.01 wt %-10 wt % of viscosity imparting agent ([0066]).
Regarding the viscosity, it is noted that the viscosity of water at 25 °C is approximately 1 mPaS, and the composition according to Serizawa is predominantly water (Example 1). Therefore, in the absence of evidence to the contrary, the viscosity of the formulations according to Serizawa will be at least 1 mPaS at 25 °C.
Regarding claims 31-32, 37-40 and 69, Serizawa discloses administering rifampicin to the retina by topical eye drop application (Examples 2-3, 5-7). Serizawa discloses treating an oxygen-induced retinopathy rat model with topical or subcutaneous injection administration of the formulation comprising rifampicin and a buffer (Example 7).
Regarding claim 4, Serizawa discloses compositions comprising 0.25-1.0% w/w rifampicin (Tables 1-3).
Regarding claim 5, Serizawa discloses compositions comprising boric acid-borax or boric acid-NaOH as the buffer (Tables 1-3).
Regarding claim 6, Serizawa discloses compositions comprising Tween® 80 (i.e., polysorbate 80) as the viscosity imparting agent (Tables 1-3).
Regarding claim 16, Serizawa discloses compositions comprising 0.5 or 1% w/w rifampicin (Tables 1-3).
Regarding claim 33, Serizawa discloses topical administration to the eye in a single dose (Examples 5-6).
Regarding claim 34-36, Serizawa discloses eye drop formulations administered to the eye in a volume of 5 or 15 µL (Examples 3, 5-6).
Regarding claim 42, Serizawa discloses that the dose contained rifampicin in a concentration of 0.25-1.0 g/100ml of composition (25-100 mg/kg) (Example 2).
Regarding claims 44 and 65, Serizawa discloses an eye drop formulation administering daily to the eyes for 5 days (Example 7).
Regarding claims 45 and 66, Serizawa discloses that administering the formulations topically to the eye results in rifampicin delivered to the retina (Examples 3 and 5-7).
Regarding claims 47 and 67, Serizawa discloses that administering the eye drop formulations resulted in inhibition of neovascularization in sub-retina tissues (Example 7).
Regarding claims 48, 50 and 68, Serizawa discloses administration of an eye-drop solution comprising the same components as instantly claimed. Therefore, in the absence of evidence to the contrary, the eye-drop solution of Serizawa will inherently result in at least about a 5-fold reduction in plasma exposure of the rifampicin relative to oral dosing at 300 mg.
Regarding claims 64 and 72, Serizawa discloses that loss of visual acuity is a common problem associated with aging and with various diseases of the eye such as macular degeneration, ocular histoplasmosis syndrome, myopia, diabetic retinopathy and inflammatory diseases all of which result from neovascularization in the cornea, retina or choroid ([0003]). Age-Related Macular Degeneration (AMD) is a common eye condition which usually affects older adults and results in a loss of vision in the center of the visual field (the macula) due to retinal damage ([0004]). In some embodiments, the said treatment reduces or reverses the loss of visual acuity secondary to neovascularization of cornea, iris, retina or choroid ([0043]).
Therefore, the application of the formulations according to Serizawa improves vision, increases visual acuity, and/or increases visual field.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 52-53, 56-58, 62 and 70-71 are rejected under 35 U.S.C. 103 as being unpatentable over Serizawa (US 2017/0202850 A1).
The teachings of Serizawa are discussed above.
Serizawa does not explicitly disclose an example of treating a neovascular eye disease recited in claim 52, including dry AMD, wet AMD, and diabetic retinopathy, as recited in claims 53, 56, 58, 62 and 70-71.
Regarding claims 52 and 58, Serizawa teaches a method of treating visual disorders such as age-related macular degeneration (AMD), ocular neovascularization, optic neuropathy, glaucoma, degeneration of optic nerves, ophthalmoplegia, retinal ganglion cell injury and brain damage ([0040]; Claims 2, 4-8, 14, 18, 22-23). In some embodiments, the ocular disease, disorder, injury or condition is selected from the group consisting of macular degeneration, diabetic retinopathy, chronic glaucoma, retinal detachment, sickle cell retinopathy, age related macular degeneration (AMD), retinal ganglion cell injury, rubeosis iritis, inflammatory diseases, chronic uveitis, neoplasms, Fuchs' heterochromic iridocyclitis, neovascular glaucoma, corneal neovascularization, choroidal neovascularization, retinal neovascularization, retinal angiomatous proliferation, and the like ([0042]-[0047]). Serizawa also teaches a method of treating
Regarding claims 53 and 70, Serizawa teaches in some embodiments, the method includes treatment of dry form of AMD. In other embodiments, the method includes treatment of wet form of AMD ([0044]).
Regarding claims 56 and 71, Serizawa teaches that in dry (non-exudative) form, cellular debris called drusen accumulates between retina and choroid ([0004]).
Regarding claim 57, Serizawa teaches that compounds and pharmaceutical compositions of this invention may be used alone or in combination with other compounds. When administered with another agent, the co-administration can be in any manner in which the pharmacological effects of both are manifest in the patient at the same time. Thus, co-administration does not require that a single pharmaceutical composition, the same dosage form, or even the same route of administration be used for administration of both the compound of this invention and the other agent or that the two agents be administered at precisely the same time. However, co-administration will be accomplished most conveniently by the same dosage form and the same route of administration, at substantially the same time. Obviously, such administration most advantageously proceeds by delivering both active ingredients simultaneously in a novel pharmaceutical composition in accordance with the present invention ([0049]). Serizawa further teaches that intravitreal injection with anti-vascular endothelial growth factor (anti-VEGF) therapy has become the criterion standard for treatment of choroidal neovascular membranes (CNVs) associated with AMD. Treatment options in wet AMD include bevacizumab (Avastin, Genentech, San Francisco, Calif.), which is a full-length anti-VEGF antibody, ranibizumab (Lucentis, Genentech), which is an affinity-matured fragment, pegaptanib sodium (Macugen, OSI/Eyetech Inc.), and aflibercept (Eylea, Regeneron, Tarrytown, N.Y.), and other anti-VEGF drugs ([0004]).
Regarding claim 62, Serizawa teaches a method of treating visual disorders such as diabetic retinopathy, glaucoma and retinal detachment ([0040], [0042]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare ophthalmic formulations comprising a rifamycin compound, such as rifampicin, rifabutin, rifapentine and rifaximin, and a buffer, for topical and/or systemic administration to a patient for the treatment of age-related macular degeneration (e.g., dry AMD or wet AMD), diabetic retinopathy, glaucoma, retinal detachment, etc., as well as reduction of symptoms associated with said diseases or conditions. A person of ordinary skill in the art would also have been motivated to combine the treatment with another active agent, such as anti-VEGF therapy drugs, as reasonably suggested by Serizawa. A person of ordinary skill in the art would have a reasonable expectation of success because Serizawa teaches that the rifamycin compound is suitable for the treatment of an ocular disease, disorder or condition, and provides examples of topical and systemic administration resulting in rifampicin being delivered to the retina, and the rifampicin treatment reducing neovascularization (Example 7).
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 1-2, 4-6, 8, 16, 31-40, 42, 44-45, 47-48, 50, 52-53, 56-58, 62, and 64-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/267,715 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘715 Application claims a topical eye drop composition, and a medicament for treatment of an ocular disease, disorder or condition, wherein the topical eye drop composition comprises an aqueous solution formulation comprising a rifamycin compound selected from the group consisting of rifampicin, rifabutin, rifapentine, and rifaximin, or a pharmaceutically acceptable salt thereof, a buffer solution, and a nonionic surfactant, and the ocular disease, disorder or condition being treated is the same as instantly claimed. The ‘715 Application further claims that the effective concentration of the rifamycin compound is 0.1% to 10% by weight. The ‘715 Application does not explicitly claim the viscosity of the topical eye drop composition, but the claimed compositions will, in the absence of evidence to the contrary, inherently have a viscosity of at least 1 mPaS at 25 °C, which is the approximate viscosity of water.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-6, 8, 16, 31-40, 42, 44-45, 47-48, 50, 52-53, 56-58, 62, and 64-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-31, 33-36, and 40-46 of copending Application No. 18/507,906 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘906 Application claims an ophthalmic composition, and a method of treating an ocular disease, disorder, or condition, wherein the ophthalmic composition comprises a suspension of a rifamycin compound selected from the group consisting of rifampicin, rifabutin, rifapentine, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable vehicle, a tonicity adjusting agent, and a pH buffering agent. Also, the ocular disease, disorder, or condition is the same as instantly claimed. The ‘906 Application does not explicitly claim the viscosity of the ophthalmic composition, but the claimed compositions will, in the absence of evidence to the contrary, inherently have a viscosity of at least 1 mPaS at 25 °C, which is the approximate viscosity of water, since they comprise water or vegetable oil as the pharmaceutically acceptable vehicle.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-6, 8, 16, 31-40, 42, 44-45, 47-48, 50, 52-53, 56-58, 62, and 64-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,850,213. Although the claims at issue are not identical, they are not patentably distinct from each other because US ‘213 claims a method of treating an ocular disease, disorder, or condition which results from ocular neovascularization comprising topically administering to a patient in need thereof a stable ophthalmic composition comprising about 0.01 wt% to 10 wt% of a solubilized rifamycin compound selected from the group consisting of rifampicin, rifabutin, rifapentine, and rifaximin, or a pharmaceutically acceptable salt thereof, and the pH is buffered with a buffering agent. Also, US ‘213 claims that the ocular neovascularization comprises retinal or choroidal neovascularization, which are instantly claimed neovascular eye diseases. US ‘213 does not explicitly claim the viscosity of the ophthalmic composition, but the claimed compositions will, in the absence of evidence to the contrary, inherently have a viscosity of at least 1 mPaS at 25 °C, which is the approximate viscosity of water.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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/N.W.S/Examiner, Art Unit 1616
/MONICA A SHIN/Primary Examiner, Art Unit 1616
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