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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Aug. 13, 2025 has been entered.
Claims 2-6, 18-20, and 22-33 are pending. Claims 2-6, 18-20, and 22-33 are examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant's election with traverse of the species triamcinolone in the reply filed on 6/28/24 is acknowledged. The traversal is on the ground(s) that there is no reason.
This is not found persuasive because a search of one group is not coextensive with the search of the other groups. Thus, it would be burdensome to search the entire claims.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/28/23, 10/17/23, 8/4/21, 6/24/21 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-6, 18-20, and 22-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for macular degeneration, age-related macular degeneration (AMD), retinitis pigmentosa (RP), glaucoma, a corneal disease, retinal detachment, central serous chorioretinopathy, cone dystrophy, cone-rod dystrophy, macular hole, and condition of degenerative photoreceptor cel death, does not reasonably provide enablement for hereditary eye disease such as Aniridia. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and the breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Limited amount of guidance and limited number of working examples in the specification
While the Specification recited macular degeneration, age-related macular degeneration (AMD), retinitis pigmentosa (RP), glaucoma, a corneal disease, retinal detachment, central serous chorioretinopathy, cone dystrophy, cone-rod dystrophy, macular hole, and condition of degenerative photoreceptor cel death, there is no prevention or treatment of retinal eye disease that occur in infants.
Nature of the invention
Inherited eye disorders refer to a broad group of clinically and genetically heterogeneous conditions which impact vision and are collectively an important cause of vision impairment in children. Aniridia refers to the partial or complete absence of the iris and is also a whole eye developmental disorder, usually associated with a spectrum of additional ocular findings including foveal and/or optic nerve hypoplasia (see 2.2.1.1, Lin et al., 2025, Journal of Paediatrics and Child Health; 61:1538–1548). Thus it would be impossible to prevent or treat someone with missing iris.
State of the prior art
Genetic testing is an important component of the diagnostic workup of inherited eye disorders. In many cases, it can be difficult to make a definitive clinical diagnosis due to phenotypic overlap (Lin et al., 4. Genetic Testing & Multidisciplinary Collaboration). Therefore, the prevention of ocular conditions are impossible.
Relative skill level of those in the art
Those in the art would have a difficult time preventing ocular conditions caused by genetic abnormalities because the genes are not in one loci. Therefore, the relative skill level required would be high.
Predictability or unpredictability in the art
Because of genetic locations are not easy to map, the unpredictability in the art would be high.
The breadth of the claims
The breadth of the claims is broad, particularly for preventing all ocular diseases that are congenital.
Applicant’s claims are broadly drawn to a composition that is able to prevent or treat all ocular diseases. In order to be enabled for prevention of a condition, applicant must demonstrate that the invention is able to prevent the condition each and every instance of that condition. Applicant’s specification does not set forth any evidence that the claimed product is able to prevent ocular damage when the condition is caused by genetic hereditary. In addition, the art teaches ocular disease such as Aniridia prevention is not accepted as possible because it is from genetic defects (Lin et al., 2025, Journal of Paediatrics and Child Health; 61:1538–1548 https://doi.org/10.1111/jpc.70168). Because applicant’s specification does not show prevention of all ocular diseases and the art acknowledges that prevention is not currently possible, a person of ordinary skill in the art would be forced to experiment unduly in order to determine if applicant’s invention actually functions as claimed. Therefore, the claims are not considered enabled for the prevention or treatment of all ocular defects.
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 2-6, 20, 22, 23 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the therapeutic drug" in line 3. Claim 3 recites the limitation "the therapeutic drug" in line 4. Claim 4 recites the limitation "the therapeutic drug" in line 5. Claim 5 recites the limitation "the therapeutic drug" in line 4. Claim 6 recites the limitation "the therapeutic drug" in line 3. Claim 20 recites the limitation "the therapeutic drug" in line 3. Claim 18 does not have “a therapeutic drug”; therefore, there is lack of antecedent basis.
In Claim 22 and 23, “the period of time” lacks antecedent basis because Claim 18 does not have the phrase.
In Claim 29, “the allogenic stem cells” lacks antecedent basis because no stem cells were mentioned in Claim 18.
There is insufficient antecedent basis for this limitation in the claims.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 2, 3, 6, 18-20, 22-24, 28-29, and 32-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lashkari et al. (US 20090238800A1). This is a new rejection.
Lashkari et al. teaches a method of treating a dystrophic eye of a mammal, comprising introducing the adult retinal stem cells of replenishing retinal ganglion cells comprising introducing autologous adult retinal stem cells into the eye of said mammal (Claims 58, 55). The dystrophic eye is the result of age-related macular degeneration, early onset macular degeneration, Usher Syndrome, retinitis pigmentosa, choroideremia, cone dystrophy, cone-rod dystrophy, rod-cone dystrophy, Leber's congential amaurosis, congential stationary night blindness, Sticklers Syndrome, colobomas, vitreoretinal dysplasia, achromatopsia, or optic nerve hypoplasia, and glaucoma (Claims 75, 76). Retinal stem cell harvesting extra-retinal ocular tissue comprising a sterile container and a harvesting solution, wherein said kit allows the survival of said tissue until later dissociation of cells from said tissue (Claim 78). Adult stem cell lines are provided with culture media for growing or maintaining adult retinal stem cells comprising a serum-free culture medium [0005]. The cells are allogenic cells from another person for culturing to produce retinal stem cells. Dissection would require 3 dimensional structure. The characterization of the retinal stem cells obtained from these membranes can be accomplished by immunocytochemistry (ICC) and reverse-transcriptase polymerase chain reaction (RT-PCR) by techniques known to one of skill in the art [0047]. 60% or more of the total number of cells contained in a piece of the retinal tissue are cells expressing at least one of TGF beta, PAX6, Chx10, and Crx would be inherently present because the cells are of the same origin, thus Claims 24, 32, 33 are met. A neural retinal progenitor cell layer would contain pluripotent stem cells; thus, Claim 29 is met. No immunosuppressive agents are taught in the reference; therefore, Claims 20, 22, 23 are met.
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.
Claim(s) 2- 6, 18-20, and 22-33 are rejected under 35 U.S.C. 103 as being unpatentable over Lashkari et al. (US 20090238800 A1) in view of Chappell et al. (US 20070105761 A1). This is a new rejection.
Lashkari et al. teaches a method of treating a dystrophic eye of a mammal, comprising introducing the adult retinal stem cells of replenishing retinal ganglion cells comprising introducing autologous adult retinal stem cells into the eye of said mammal (Claims 58, 55). The dystrophic eye is the result of age-related macular degeneration, early onset macular degeneration, Usher Syndrome, retinitis pigmentosa, choroideremia, cone dystrophy, cone-rod dystrophy, rod-cone dystrophy, Leber's congential amaurosis, congential stationary night blindness, Sticklers Syndrome, colobomas, vitreoretinal dysplasia, achromatopsia, or optic nerve hypoplasia, and glaucoma (Claims 75, 76). Retinal stem cell harvesting extra-retinal ocular tissue comprising a sterile container and a harvesting solution, wherein said kit allows the survival of said tissue until later dissociation of cells from said tissue (Claim 78). Adult stem cell lines are provided with culture media for growing or maintaining adult retinal stem cells comprising a serum-free culture medium [0005]. The cells are allogenic cells from another person for culturing to produce retinal stem cells. Dissection would require 3 dimensional structure. The characterization of the retinal stem cells obtained from these membranes can be accomplished by immunocytochemistry (ICC) and reverse-transcriptase polymerase chain reaction (RT-PCR) by techniques known to one of skill in the art [0047]. 60% or more of the total number of cells contained in a piece of the retinal tissue are cells expressing at least one of TGF beta, PAX6, Chx10, and Crx would be inherently present because the cells are of the same origin, thus Claims 24, 32, 33 are met. A neural retinal progenitor cell layer would contain pluripotent stem cells; thus, Claim 29 is met. No immunosuppressive agents are taught in the reference; therefore, Claims 20, 22, 23 are met.
However, Lashkari et al. does not teach diameter in the major axis direction of the retinal tissue is 0.2 mm or more, total number of cells contained in a piece of the retinal tissue is 1x104 cells or more, 50% or more by area of a continuous epithelial structure, sphere-shaped cell aggregate, triamcinolone.
Chappell et al. teaches a method of treating an ophthalmic disorder in a patient, said method comprising administering to said patient a composition comprising a corticosteroid and a non-steroidal immunophilin-dependent immunosuppressant, wherein at least one of said corticosteroid and said non-steroidal immunophilin-dependent immunosuppressant is present at a low concentration (Claim 1), such as triamcinolone (Claim 2). The ophthalmic disorder includes age related macular degeneration, alkaline erosive keratoconjunctivitis, allergic conjunctivitis, allergic keratitis, anterior uveitis, Behcet's disease, blepharitis, blood-aqueous barrier disruption, chorioiditis, chronic uveitis, conjunctivitis, contact lens-induced keratoconjunctivitis, corneal abrasion, corneal trauma, corneal ulcer, crystalline retinopathy, cystoid macular edema, dacryocystitis, diabetic keratophathy, diabetic macular edema, diabetic retinopathy, dry eye disease, dry age-related macular degeneration, eosinophilic granuloma, episcleritis, exudative macular edema, Fuchs' Dystrophy, giant cell arteritis, giant papillary conjunctivitis, glaucoma, glaucoma surgery failure, graft rejection, herpes zoster, inflammation after cataract surgery, iridocorneal endothelial syndrome, iritis, keratoconjunctiva sicca, keratoconjunctival inflammatory disease, keratoconus, lattice dystrophy, map-dot-fingerprint dystrophy, necrotic keratitis, neovascular diseases involving the retina, uveal tract or cornea such as neovascular glaucoma, corneal neovascularization, neovascularization resulting following a combined vitrectomy and lensectomy, neovascularization of the optic nerve, and neovascularization due to penetration of the eye or contusive ocular injury, neuroparalytic keratitis, non-infectious uveitisocular herpes, ocular lymphoma, ocular rosacea, ophthalmic infections, ophthalmic pemphigoid, optic neuritis, panuveitis, papillitis, pars planitis, persistent macular edema, phacoanaphylaxis, posterior uveitis, post-operative inflammation, proliferative diabetic retinopathy, proliferative sickle cell retinopathy, proliferative vitreoretinopathy, retinal artery occlusion, retinal detachment, retinal vein occlusion, retinitis pigmentosa, retinopathy of prematurity, rubeosis iritis, scleritis, Stevens-Johnson syndrome, sympathetic ophthalmia, temporal arteritis, thyroid associated ophthalmopathy, uveitis, vernal conjunctivitis, vitamin A insufficiency-induced keratomalacia, vitreitis, and wet age-related macular degeneration (Claim 11).
The reference does not specifically teach total number of cells contained in a piece of the retinal tissue is 1x104 cells or more, 50% or more by area of a continuous epithelial structure, sphere-shaped cell aggregate claimed by applicant for treatment of retinal cells. However, the reference does teach the composition for treating glaucoma. Lashkari et al. teaches a method of treating a dystrophic eye of a mammal, comprising introducing the adult retinal stem cells of replenishing retinal ganglion cells comprising introducing autologous adult retinal stem cells into the eye of said mammal (Claims 58, 55) The amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to include triamcinolone because Chappell et al. teaches a method of treating an ophthalmic disorder in a patient, said method comprising administering to said patient a composition comprising a corticosteroid and a non-steroidal immunophilin-dependent immunosuppressant, wherein at least one of said corticosteroid and said non-steroidal immunophilin-dependent immunosuppressant is present at a low concentration (Claim 1). One would have been motivated to include triamcinolone for the expected benefit of minimizing graft resistant in a retinal transplant. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655