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 .
Claims 2-9 and 11-22 are presented for examination.
Restriction/Election
Applicant in the reply filed on 02/10/2026 amended the claims to be dependent on claim 22, which was Group III in the restriction requirement of 09/29/2025.
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.
Claim 22 is 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 22 is indefinite as to the phrase “a neural retina-related cell”. The phrase fails to set forth the metes and bounds of the claimed invention. The term is a relative term, which is not defined by the claims or specification.
The claims depending on claim 22 are also rejected, since they have all the limitations of claim 22.
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.
Claim(s) 2, 3 and 22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tian et al. (Screening and optimizing of potential injection vehicles for storage of retinal pigment epithelial stem cell before transplantation)(submitted by the applicant).
Regarding claim 22, Tian et al. teach the subretinal transplantation of stem cell-derived retinal pigment epithelial cell suspension for recovering damaged retina and improving vision. Tian teaches that the Food and Drug administration has approved natural polymers, such as alginate, methyl cellulose and hyaluronic acid as cell vehicles for adult human RPE stem cells. See the abstract. The viscosity of 0.95 to 92.3 overlapping with the claimed viscosity is taught in table 1. The sheer rate of 2 (1/s) is the inherent property of Tian’s composition, considering that Tian uses the same vehicle, balanced salt solution as claimed herein.
Regarding claim 2, Tian et al. teach the viscosity overlapping with the viscosity of claim 2. See Table 1. The sheer rate of 2 (1/s) is the inherent property of Tian’s composition, considering that Tian uses the same vehicle, balanced salt solution as claimed herein.
Regarding claim 3, Tian et al. teach the viscosity overlapping with the viscosity of claim 3. See Table 1. The sheer rate of 2 (1/s) is the inherent property of Tian’s composition, considering that Tian uses the same vehicle, balanced salt solution as claimed herein.
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.
Claim(s) 2-9 and 11-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tian et al. (Screening and optimizing of potential injection vehicles for storage of retinal pigment epithelial stem cell before transplantation)(submitted by the applicant) in view of Manda et al. (WO 2019017491)(submitted by the applicant) and further in view of Nasonkin et al. (US 20210155895).
The claims are drawn to a method for treating a disease caused by the damage of a neural
retina-related cell or a neural retina or the injury of a neural retina in a subject in need thereof,
comprising subretinally transplanting, to the subject, a transplant retinal tissue and a vehicle,
wherein the vehicle has a viscosity of 5 to 500 mPa-s at a shear rate of 2 (1/s) at 25°C and comprises hyaluronic acid and a pharmaceutically acceptable aqueous liquid.
Regarding claim 22, Tian et al. teach the subretinal transplantation of stem cell-derived retinal pigment epithelial cell suspension for recovering damaged retina and improving vision. Tian teaches that the Food and Drug administration has approved natural polymers, such as alginate, methyl cellulose and hyaluronic acid as cell vehicles for adult human RPE stem cells. See the abstract. The viscosity of 0.95 to 92.3 overlapping with the claimed viscosity is taught in table 1.
Regarding claim 2, Tian et al. teach the viscosity overlapping with the viscosity of claim 2. See Table 1.
Regarding claim 3, Tian et al. teach the viscosity overlapping with the viscosity of claim 3. See Table 1.
Regarding claim 4, Tian et al. does not teach the pH of 7.0-7.5, however Manda et al. teach a method of preserving neural tissues derived from stem cell, such as retina tissues, wherein the solution has the pH of 6-8.6. See claim 12.
Regarding claim 5, Tian et al. teach that polymers were dissolved in balanced salt solution. See page 78, first column.
Regarding claim 6, Tian et al. teach hyaluronic acid at the dosage of 0.5%, which is within the scope of the claimed concentration of 0.15 w/v% to 1.5 w/v%. See page 78, second column. The determination of molecular weight is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 7, Tian et al. teach the use of polymers, such as, hyaluronic acid, carboxymethyl cellulose and alginate, but does not teach the use of chondroitin sulfate. However, Manda et al. teach, a method of preserving neural tissues derived from stem cell, such as retina tissues, wherein the storage solution comprises chondroitin sulfate and hyaluronic acid. See claims 4, 5, 9 and 15. It would have been obvious to a person skilled in the art to incorporate chondroitin sulfate into the composition of Tian, motivated by the teachings of Manda et al, which teach the use of chondroitin sulfate in a storage solution for preserving neural tissues derived from stem cells.
Regarding Claim 8, Tian does not teach the use of chondroitin sulfate. However, Manda et al. teach, a method of preserving neural tissues derived from stem cell, such as retina tissues, wherein the storage solution comprises chondroitin sulfate and hyaluronic acid. See claims 4, 5, 9 and 15. Manda et al. teach that The concentration of chondroitin sulfate is, is 0.1% (w / v) or more and 10% (w / v) or less, which overlaps with the claimed concentration. See claim 15.
Regarding claim 9, Tian et al. does not teach the use of an antimicrobial or antiseptic agents.
Regarding claim 11, Tian et al. does not teach wherein the transplant is neural retina sheet. However, Nasonkin teaches a method for producing a neural retinal sheet/tissue slice, wherein the neural retina sheet is derived from a pluripotent stem cell. See title, abstract, Para [0003], Figure 33. It would have been obvious to a person skilled in the art to transplant neural retina sheet, motivated by the teachings of Nasonkin, which a method for producing a neural retinal sheet/tissue slice, wherein the neural retina sheet is derived from a pluripotent stem cell.
Regarding claim 12, Manda teaches Epithelial cells have apical-basal polarity of cells. The apical side is often the space side, while the basal side has a basement membrane and is in contact with the extra-cellular matrix. See Description, paragraph 3. The determination of the size and the thickness of retinal sheet is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 13, Manda teaches Epithelial cells have apical-basal polarity of cells. The apical side is often the space side, while the basal side has a basement membrane and is in contact with the extra-cellular matrix. See Description, Paragraph 3. Manda also teaches that the neural tissue or retinal tissue produced by the above-mentioned method forms cell aggregates, and in one aspect, the aggregates are (1) round, (2) smooth in surface, (3) disorganized and (4) the inside of the aggregate is dense. See description of Embodiment, paragraph 40.
Regarding claim 14, the determination of number of neural retina sheets and the amount of vehicle for transplantation is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 15, Nasonkin teaches a method for producing a neural retinal
sheet/tissue slice, wherein the neural retina sheet is (1) derived from a pluripotent stem cell [title,
abstract, 0003, Figure 33]; (2) having a three-dimensional structure [0003]; (3) comprising a neural
retinal layer having a plurality of layer structures including a photoreceptor layer and an inner layer
[0011, 0039, 0121]; (4) the photoreceptor layer comprising one or more cells selected from the group consisting of a photoreceptor precursor cell and a photoreceptor cell [0011, 0039]; (5) the inner layer
comprising one or more cells selected from the group consisting of a retinal precursor cell, a ganglion
cell, an amacrine cell, and a bipolar cell [0012, 0066, 0077], (6) the surface of the neural retinal layer
having an apical surface [0074, 0094, 0189, Figure 1]; (7) the inner layer being present inside the
photoreceptor layer present along the apical surface [0011, 0122, 0187, Figure 1, 9, 10, 16]; (8) the area
of the neural retinal layer being 50% or more with respect to the total area of the surface of the neural
retinal sheet [Figure 10, 16, 33]; (9) the area of a continuous epithelium structure being 80% or more
with respect to the total area of the apical surface of the neural retinal layer [Figure 1, 9, 15, 16, 26];
(10) the expression of a neural retina-related cell-related gene(s) being found [0014-0023, Figure 20, 33]
and the expression of non-neural retina-related cell-related gene(s) being not found in the neural retina
sheet, wherein the non-neural retina-related cell-related gene(s) comprise one or more genes selected
from the group consisting of cerebrospinal tissue marker gene and eyeball-related tissue marker gene
[0026-0027, 0141-0142, 302-303, claims 14-15].
Regarding claim 16, Nasonkin teaches a method for producing a neural retinal
sheet/tissue slice, wherein the neural retina sheet is (1) derived from a pluripotent stem cell [title,
abstract, 0003, Figure 33]; (2) having a three-dimensional structure [0003]; (3) comprising a neural
retinal layer having a plurality of layer structures including a photoreceptor layer and an inner layer
[0011, 0039, 0121]. The determination of the size and thickness is considered to be within the skill of the artisan in the absence of evidence to the contrary.
Regarding claim 17, Nasonkin teaches that the cell aggregate containing the neural retina contains a first epithelial tissue (e.g., an outer apical RPE layer) attached to the transplant neural retina/ containing the transplant neural retina, and a second epithelial tissue (e.g., an inner core of basal RPE layer) [0011, Figures 1, 10, 16]. Nasonkin teaches that wherein the second epithelial tissue is eyeball- related tissue comprising RPE cells [0011, Figure 1].
Regarding claim 18-21, Nasonkin teaches cells in the retinal organoid express or more genes selected from the group consisting of RAX, CHX10, PAX6 and CRX. The determination of cell ratios is considered to be within the skill of artisan in the absence of evidence to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617