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
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
2. Applicant’s amendment filed October 29, 2025 is acknowledged. Claims 2-3, 7-8 and 12-13 are canceled. Claims 1, 5-6 and 11 are amended. Claims 1, 4-6, 9-11 and 14-15 are pending in this application. Election was made without traverse in the reply filed on August 2, 2023.
3. Claims 1, 4-6, 9-11 and 14-15 are under examination in this office action.
4. Applicant’s arguments filed on October 29, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
5. The rejection of claims 1, 4-6, 9-11 and 14-15 under 35 U.S.C. 103 as being unpatentable over Ng et al. (SM Opthalmol. J. 2015; 1:1003) in view of Hauser et al. (Stem Cells and Development, 2012; 21) is withdrawn in response to Applicant’s amendment to the claims.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on October 29, 2025.
Claim Rejections - 35 USC § 102
6. 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.
(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.
Claims 1, 4-6, 9-11 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheung (US10106773, cited previously).
Claims 1, 4-6, 9-11 and 14-15 as amended are drawn to methods of treating a retinal degeneration, comprising administering to a subject in need thereof human neural crest-derived nasal inferior turbinate stem cells (hITSCs) or a cellular therapeutic agent or a quasi-drug composition comprising the claimed hITSCs, wherein the hITSCs are subcultured and possess the differentiation capacity to develop into rod photoreceptor cells among photoreceptors.
Cheung (US10106773) teaches a method of treating a retinal degenerative disease, comprising administering to a subject in need thereof a composition comprising adherent human adult stem cells isolated from neural crest derived tissue nasal turbinate (see col. 7, lines 49-61; col. 8, lines 24-26; col.8, lines 28-33; col.8, line 45-col.9, line 30), which are adherent human neural crest-derived nasal turbinate stem cells isolated from human nasal turbinate which includes inferior turbinate and include the claimed adherent human neural crest-derived nasal inferior turbinate; wherein the retinal degenerative disease includes retinitis pigmentosa, age-related macular degeneration, glaucoma (See col.7, lines 30-col. 8, lines 60; col. 15, lines 22-23; 34-45; col. 25-31, Example 4). Cheung teaches that the adherent human neural crest-derived nasal turbinate stem cells express connexin 43, stem cell markers including Oct4, Nanog, Sox2, Klf4 or combination thereof and neural crest markers including p75 neurotrophin receptor, Nestin, Sox10, N-cadherin, Notch1, BMP2, Slug, Snail or combination thereof (see col. 8, lines 45-col. 9, lines 6). Cheung teaches that the human neural crest-derived nasal turbinate stem cells can differentiate into rod photoreceptors expressing rhodopsin as recited in claims 1, 4, 6, 9, 11 and 14 (see col. 6, lines 36-37). Cheung teaches different administration routes including intravitreal as in claims 5, 10 and 15 (see col.15, lines 24-63). Thus, claims 1, 4-6, 9-11 and 14-15 are anticipated by Cheung (US10106773).
Claim Rejections - 35 USC § 103
7. 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1, 4-6, 9-11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Cheung (US10106773) in view of Greiner et al. (Eur. Cells and Materials, 2011; 22:403-419. DOI:10.22203/eCM.v022a30).
Even if Cheung does not explicitly teach the adherent human neural crest-derived nasal turbinate stem cells are only isolated from the human nasal inferior turbinate, Greiner teach this limitation and provides motivation and an expectation of success in isolating adherent human neural crest-derived nasal inferior turbinate stem cells (hITSCs) from nasal inferior turbinate in the Cheung’s method.
Greiner et al. teaches that culturing adherent human neural crest-derived nasal inferior turbinate stem cells (hITSCs) and subculturing adherent hITSCs is efficient to obtain adherent hITSCs and their use for treatment of neurodegenerative diseases (see p.403, abstract; p. 404, 2nd col. section: cultivation of ITSCs using human blood plasma derived 3D matrix to p. 405, 1st col., 1st paragraph; p. 408-409, figure 3).
A person of ordinary skill in the art would have recognized that selecting and applying the known adherent hITSCs isolated from a human adult inferior turbinate and the known technique of culturing and isolating hITSCs disclosed by Greiner to the Cheung’s method would have yielded the predictable result of obtaining adherent hITSCs for treating a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration, glaucoma, and resulted in an improved method of using adherent hITSCs for treatment of a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration or glaucoma.
Culturing and isolating adherent hITSCs from a human nasal inferior turbinate to obtain hTMSCs is an efficient method to obtain adherent hITSCs and can be used for treatment of neurodegenerative diseases. Isolating and using adherent hITSCs in the Cheung’s method would better obtain adherent hITSCs for treating a neurodegenerative disease or a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration, glaucoma, and expand application of the Cheung’s method, and would also increase patient’s satisfaction with treatment of a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration, glaucoma using adherent hITSCs.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known adherent hITSCs isolated from a human adult inferior turbinate and the known technique of culturing and isolating hITSCs disclosed by Greiner to the Cheung’s method and yield the predictable result of treating a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration, glaucoma because isolating adherent hITSCs from the human nasal inferior turbinate is efficient, and adherent hITSCs can be used for treatment of neurodegenerative diseases including retinal degenerative diseases using stem cell therapy.
8. Claims 5, 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cheung (US10106773) in view of Greiner et al. (2011) as applied to claims 1, 4-6, 9-11 and 14-15 above, and further in view of Ng et al. (SM Opthalmol. J. 2015; 1:1003, cited previously).
Cheung and Greiner are set forth above but fail to teach subretinal injection recited in claims 5, 10 and 15.
Ng et al. teaches methods of treating a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration, glaucoma (See p.2, col. 1, section: Current Progress of Mesenchymal Stem cells in Ocular Research to p. 3, col.2; p. 3, col.2, section: Human Clinical Trials using Stem cell in Ophthalmology to p. 6, tables 2-5), which are the diseases with retinal degeneration, comprising intravitreal or subretinal administering recited in claims 5, 10 and 15 (see p. 2, col.2, paragraph 2; p. 3, col.2, section: Human Clinical Trials using Stem cell in Ophthalmology to p. 6, tables 2-5) to a subject in need thereof a composition comprising different stem cells including neural crest-derived stem cells (NCSCs), mesenchymal stem cells (MSCs) and wherein the MSCs differentiate into rod photoreceptors expressing rhodopsin recited in claims 1, 4, 6, 9 11 and 14 (p. 3, col.2, section: Human Clinical Trials using Stem cell in Ophthalmology).
A person of ordinary skill in the art would have recognized that selecting and applying the known comprising intravitreal or subretinal injection of neural-crest stem cells or hITSCs for treatment of retinal degenerative diseases including retinitis pigmentosa, age-related macular degeneration, glaucoma to the method of Cheung and Greiner would have yielded the predictable result of treating a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration, glaucoma, and resulted in an improved method of using adherent hITSCs for treatment of a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration or glaucoma.
Using and administering adherent hITSCs by intravitreal or subretinal injection in the method of Cheung and Greiner would treat a neurodegenerative disease or a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration, glaucoma, and expand application of the method of Cheung and Greiner, and would also increase patient’s satisfaction with treatment of a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration, glaucoma using stem cells including adherent hITSCs from the nasal inferior turbinate.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known comprising intravitreal or subretinal injection of neural-crest stem cells or hITSCs for treatment of retinal degenerative diseases including retinitis pigmentosa, age-related macular degeneration, glaucoma and the known technique disclosed by Ng to the method of Cheung and Greiner, and yield the predictable result of treating a retinal degenerative disease including retinitis pigmentosa, age-related macular degeneration, glaucoma because intravitreal or subretinal injection of neural-crest stem cells or hITSCs can be used for treatment of retinal degenerative diseases including retinitis pigmentosa, age-related macular degeneration, glaucoma.
Conclusion
9. NO CLAIM IS ALLOWED.
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hwang et al. (PLoS ONE; 2013; 8:474330. Doi:10.1371/journal.pone.0074330) teach isolation of adult human MSCs from a human adult inferior turbinate (see p.2, col.1-col.2; p. 3, col.2, section: Results to p.7, col.2).
Labrador-Velandia et al. (World J. Stem cells, 2016; 8:376-383. DOI:10.4252/wjsc.v8.i11.376) teach methods of treating a retinal degenerative disease, comprising administering to a subject in need thereof a composition comprising different stem cells including mesenchymal stem cells (MSCs); wherein the retinal degenerative disease includes retinitis pigmentosa, Stargardt’s disease, age-related macular degeneration, glaucoma (See p. 378, Section: CLINICAL TRIALS USING MSCS to p.381, Table 1)); and wherein the administering includes intravitreal injection or subretinal injection recited in claims 5, 10 and 15 (see p. 379, table 1) to the subject with different retinal degenerative diseases including retinitis pigmentosa, Stargardt’s disease, age-related macular degeneration, glaucoma (p, 378-381, table 1).
Holan et al. (Cells, published 7 March 2021; 10:588. Doi.org/10.3390/cells10030588) teach methods of treating a retinal degenerative disease, comprising administering to a subject in need thereof a composition comprising mesenchymal stem cells (MSCs); wherein the retinal degenerative disease includes retinitis pigmentosa, age-related macular degeneration, glaucoma (see p.3-7; 7-13, tables 1-2) and wherein the MSCs can be isolated from adult tissues including bone marrow or adipose tissue; and wherein the administering includes intravitreal injection or subretinal injection recited in claims 5, 10 and 15 (see p. 6-7; 7-13, tables 1-2) to the subject with different retinal degenerative diseases including retinitis pigmentosa, age-related macular degeneration, glaucoma recited in claims 2, 7 and 12 (see p.6-7; 7-13, tables 1-2), and wherein the MSCs differentiate into rod photoreceptors expressing rhodopsin recited in claims 1, 4, 6, 9, 11 and 14 (see p.3).
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
February 24, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675