DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
This Office Action is in response to Applicant's continuation filed on June 3, 2024. Claim(s) 65-76 are pending and examined herein insofar as they read on the elected invention.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 65-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of U.S. Patent 9,957,724 in view Scott (WO 2009/045479). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to method for treating an ophthalmic disease or disorder associated with retinal neovascularization in the eye of a patient comprising administering a therapeutically effective amount of a composition comprising
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, wherein the ophthalmic disease or disorder associated with retinal neovascularization is selected from the group consisting of sickle cell retinopathy, Eales disease, ocular ischemic syndrome, carotid cavernous fistula, familial exudative vitreoretinopathy, hyperviscosity syndrome, idiopathic occlusive arteriolitis, radiation retinopathy, retinal vein occlusion, retinal artery occlusion, retinal embolism, birdshot retinochoroidopathy, retinal vasculitis, sarcoidosis, toxoplasmosis, uveitis, choroidal melanoma, chronic retinal detachment, incontinentia pigmenti, and retinitis pigmentosa. The patented claims teach a method for treating proliferative diabetic retinopathy in a patient having been previously diagnosed with proliferative diabetic retinopathy comprising administering to the patient a therapeutically effective amount of a composition comprising the same compound.
The instant claims do not explicitly teach diabetic retinopathy as one of the ophthalmic diseases.
Scott teaches diabetic retinopathy occurs when diabetes damages blood vessels inside the retina [00351]. Thus, diabetes retinopathy is considered a disease associated with neovascularization.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time of the invention.
Claims 65-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 of U.S. Patent 10,730,825 in view of Scott (WO 2009/045479). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to method for treating an ophthalmic disease or disorder associated with retinal neovascularization in the eye of a patient comprising administering a therapeutically effective amount of a composition comprising
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, wherein the ophthalmic disease or disorder associated with retinal neovascularization is selected from the group consisting of sickle cell retinopathy, Eales disease, ocular ischemic syndrome, carotid cavernous fistula, familial exudative vitreoretinopathy, hyperviscosity syndrome, idiopathic occlusive arteriolitis, radiation retinopathy, retinal vein occlusion, retinal artery occlusion, retinal embolism, birdshot retinochoroidopathy, retinal vasculitis, sarcoidosis, toxoplasmosis, uveitis, choroidal melanoma, chronic retinal detachment, incontinentia pigmenti, and retinitis pigmentosa. The patented claims teach a method for treating diabetic macular edema comprising administering to the patient a therapeutically effective amount of a composition comprising the same compound.
The instant claims do not explicitly teach diabetic macular edema.
Scott teaches macular edema results from central retinal vein occlusion [00356]. Thus, macular edema is considered a disease associated with neovascularization.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time of the invention.
Claims 65-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of U.S. Patent 11,795,136 in view of Scott (WO 2009/045479). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to method for treating an ophthalmic disease or disorder associated with retinal neovascularization in the eye of a patient comprising administering a therapeutically effective amount of a composition comprising
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, wherein the ophthalmic disease or disorder associated with retinal neovascularization is selected from the group consisting of sickle cell retinopathy, Eales disease, ocular ischemic syndrome, carotid cavernous fistula, familial exudative vitreoretinopathy, hyperviscosity syndrome, idiopathic occlusive arteriolitis, radiation retinopathy, retinal vein occlusion, retinal artery occlusion, retinal embolism, birdshot retinochoroidopathy, retinal vasculitis, sarcoidosis, toxoplasmosis, uveitis, choroidal melanoma, chronic retinal detachment, incontinentia pigmenti, and retinitis pigmentosa. The patented claims teach a method for treating neovascularization associated with neovascular age-related macular degeneration comprising administering to the patient a therapeutically effective amount of a composition comprising the same compound.
The instant claims do not explicitly teach age-related macular edema.
Scott teaches macular edema results from central retinal vein occlusion [00356]. Thus, macular edema is considered a disease associated with neovascularization.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time of the invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 65-76 are rejected under 35 U.S.C. 103(a) as being unpatentable over Scott (WO 2009/045479) of record.
Scott teaches a method for treating an ophthalmic disease or disorder in a subject, comprising administering to the subject a compound of Formula (F). The compound of instant claim 65 is explicitly taught ([0077]; claim 38).
Scott teaches a method of inhibiting neovascularization in the retina of an eye of a subject comprising administering to the subject a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a non-retinoid compound [0072].
Scott teaches ophthalmic diseases and disorders that may be treated include diseases, disorders, and conditions that are associated with, exacerbated by, or caused by ischemia in the retina. Retinal ischemia includes ischemia of the inner retina and the outer retina. Retinal ischemia can occur from either choroidal or retinal vascular diseases, such as central or branch retinal vision occlusion, collagen vascular diseases and thrombocytopenic purpura. Retinal vasculitis and occlusion is seen with Eales disease and systemic lupus erythematosus [00352].
Scott teaches additional ophthalmic diseases or disorders selected from age-related macular degeneration [0049], retinal detachment, hemorrhagic retinopathy, retinitis pigmentosa, cone-rod dystrophy, Sorsby's fundus dystrophy, optic neuropathy, inflammatory retinal disease, diabetic retinopathy, diabetic maculopathy, retinal blood vessel occlusion, retinopathy of prematurity, or ischemia reperfusion related retinal injury, proliferative vitreoretinopathy, retinal dystrophy, hereditary optic neuropathy, Sorsby's fundus dystrophy, uveitis, a retinal injury [0050].
Scott teaches neovascularization is the formation of new, functional microvascular networks with red blood cell perfusion, and is a characteristic of retinal degenerative disorders, including diabetic retinopathy, retinopathy of prematurity, wet AMD and central retinal vein occlusions. Preventing or inhibiting dark adaptation of rod photoreceptor cells, thereby decreasing expenditure of energy and consumption of oxygen (i e, reducing metabolic demand), may inhibit or slow retinal degeneration, and/or may promote regeneration of retinal cells, including rod photoreceptor cells and retinal pigment epithelial (RPE) cells, and may reduce hypoxia and may inhibit neovascularization [0268].
Scott teaches an alkoxyphenyl-linked amine derivative compound can be delivered to a subject by any suitable means, including, for example, orally, parenterally, intraocularly, intravenously, intraperitoneally, intranasally [00371].
Scott teaches the oral doses of the alkoxyphenyl-linked amine derivative compounds can typically range from 1.0 to 1000 mg, one to four times, or more, per day. An exemplary dosing range for oral administration is from 10 to 250 mg one to three times per day [00381].
The difference between Scott and the claimed invention is that Scott does not teach the claimed invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831,15 USPQ2d 1566 (Fed. Cir. 1990)).
However, based on the above, Scott teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Therefore, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Conclusion
Claims 65-76 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is 571-270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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