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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-3, in the reply filed on Dec. 23, 2025 is acknowledged. Applicant request examination of all pending claims, since the remaining claims have been amended to depend from the elected group. However, the claims are directed to a method of making the composition of claim 1 and do not directly depend from the composition of claim 1.
Claims 1-7 remain pending in the current application, claims 4-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The requirement for the restriction of Inventions I and II is still deemed proper and is therefore made FINAL.
Claims 1-3 have been considered on the merits.
Status of the Claims
Claims 1-7 are currently pending.
Claim 4 is amended.
Claims 4-7 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-3 have been considered on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. There is a listing of references on pg. 2-3.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms: Neurobasal™ medium in 0094, 0095; B-27™ supplement in 0094, 0095; MACSQuant® in 0140; StemFit® in 0222, 0223, 0231; TrypLE™ Select in 0223, 0224, 0239; PrimeSurface® in 0224, 0239; 20 G SurFlo® in 0229; RNeasy® Micro kit in 0258; NanoDrop™ in 0259; Veriti™ 96 well thermal cycler in 0259; Viscoat® in 0263, 0269, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
The disclosure is objected to because of the following informalities:
Claim 1 is objected to in the recitation of “a neural retina derived from a pluripotent stem cell” in lines 2-3 and “wherein the neural retina is a transplant neural retina sheet having the following features (1) to (10): (1) being derived from a pluripotent stem cell” in lines 5-7, and in the interest of improving claim form, it is suggested that the one of these phrases be deleted. The phrases are redundant.
Claim 1 is objected to in the recitation of “a matrix, the two or more cell aggregates being arranged in the matrix” in lines 4-5 and in the interest of improving claim form, it is suggested that the one of the phrase be amended to “a matrix, wherein the two or more cell aggregates being arranged in the matrix”. In other words it is suggested to include the word, “wherein” to clarify the clause.
Claim 1 is objected to in the recitation of:
“(10) the expression of neural retina-related cell-related gene being found and the expression of non-neural retina-related cell-related gene being not found in the transplant neural retina sheet, wherein the non-neural retina-related cell-related gene comprising one or more genes selected from the group consisting of brain and spinal cord tissue marker gene and eyeball-related tissue marker gene”;
and in the interest of improving claim form, it is suggested that the one of the phrase be amended to
“(10) the transplant neural retina sheet expresses a neural retina-related cell-related gene does not expresses a non-neural retina-related cell-related a brain and spinal cord tissue marker gene and an eyeball-related tissue marker gene”.
Appropriate correction is appreciated.
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 1-3 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.
In claim 1, line 15, the phrase “(6) the surface of the neural retinal layer having an apical surface”, renders the claim and its dependents indefinite, since it is unclear which surface the term “the surface of the neural retinal layer” is referring to since the neural retinal layer is composed of multiple layers and contains multiple surfaces. Furthermore, it is unclear how a surface can have an apical surface. Either it is an apical surface or not. For the purposes of compact prosecution, the phrase will be interpreted to mean that the neural retinal layer has an outer surface.
In claim 1, line 15, the phrase “(7) the inner layer being present inside the photoreceptor layer present along the apical surface”, renders the claim and its dependents indefinite, since there is insufficient antecedent basis for "the photoreceptor layer present along the apical surface" limitation in the claim. There is no prior recitation of the photoreceptor layer present along the apical surface. Additionally, it is further unclear whether recitation of "the photoreceptor layer present along the apical surface" is meant to distinguish it from any prior recited photoreceptor layer(s) which are not present along the apical surface or whether it is meant to further limit the photoreceptor layer such that the photoreceptor layer is only present at the apical surface. In addition, the term “inside” is a relative term which renders the claim indefinite. The term "inside" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is defined “outside” in claim or clear relationship of the different layers. Furthermore, it is unclear if “inside” is meant that the inner layer is physically inside photoreceptor layer or part of the photoreceptor layer or if the term “inside” is meant to describe the relationship of the layers to each other.
In claim 1, lines 20-21, the phrase "(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" renders the claim and its dependents indefinite, since it is unclear which surface the term in unclear what the continuous epithelium structure is referring to and, as explained above, it is unclear what the apical surface is referring to. Additionally, "the area of a continuous epithelium structure” lacks sufficient antecedent basis and renders the claim and its dependents indefinite. There is no mention of such an area previously in the claim.
Since claims 2 and 3 depend from indefinite claim 1 and do not clarify the above points of confusion, claims 2 and 3 must also be rejected under 35 U.S.C. § 112 (b).
Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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.
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Nasonkin et al. (WO 2019/028088 A1) (ref. of record).
With respect to claim 1, Nasonkin teaches a retinal patch (a complex) containing multiple pieces of stem cell derived tissues (two or more cell aggregates) on a carrier or scaffold (matrix) (abstract and pg. 3-4 bridging para.). Nasonkin further teaches the stem cell derived tissues of retinal patch containing neural retina (pg. 3 para. 1-2 and 4). Nasonkin teaches neural retina is a transplant neural retina sheet (pg. 19 para. 2).
With respect to claim 1 (1), Nasonkin teaches the neural retina is derived from a pluripotent stem cells (abstract, pg. 3-4 bridging para., pg. 14-15 bridging para and pg. 19 para. 1).
With respect to claim 1 (2), Nasonkin teaches the neural retina has a three-dimensional structure (pg. 15 last para.).
With respect to claim 1 (3), Nasonkin teaches the neural retina has a neural retinal layer having a plurality of layer structures including a photoreceptor layer and an inner layer (pg. 15 para. 2).
With respect to claim 1 (4), Nasonkin teaches the photoreceptor layer comprising one or more cells selected from the group consisting of a photoreceptor progenitor cell and a photoreceptor cell (pg. 15 para. 2).
With respect to claim 1 (5), Nasonkin teaches the inner layers containing retinal ganglion cells and layer of second-order retinal neurons corresponding to the inner nuclear layer of the retina (bipolar cells and amacrine cells) (pg. 15 para. 2).
Even though Nasonkin does not explicitly teach the retina surface of the neural retinal layer having an apical surface as recited in claim 1 (6), Nasonkin teach a neural retinal layer which would have an out surface. As explained in the rejections under 35 U.S.C. § 112 (b) the phrase is being interpreted to mean that the neural retinal layer has an outer surface.
With respect to claim 1 (7), Nasonkin teaches that the inner layer being present inside the photoreceptor layer present along the apical surface (pg. 15 para. 2 and Fig. 1E and Fig. 5B-D).
With respect to claim 1 (8), Nasonkin teaches the area of the neural retinal layer being 50% or more with respect to the total area of the surface of the transplant neural retina sheet (Fig. 1E).
With respect to claim 1 (9), Nasonkin teaches 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, and (Fig. 1E).
With respect to claim 1 (10), Nasonkin teaches the expression of neural retina-related cell-related genes, RCVRN and CALB2, in the transplant neural retina sheet (pg. 18 last para.).
Nasonkin does not test the cell aggregates for the expression of non-neural retina-related cell-related gene and does not teach the expression of non-neural retina-related cell-related gene being not found in the transplant neural retina sheet as recited in claim 1 (10). Similarly, Nasonkin does not teach the non-neural retina-related cell-related gene comprising one or more genes selected from the group consisting of brain and spinal cord tissue marker gene and eyeball-related tissue marker gene as recited in claim 10. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' generated neural retina cell aggregates differ, and if so to what extent, from the neural retina cell aggregates of Nasonkin. The neural retina cell aggregates of Nasonkin are the same or similar because they are being derived from pluripotent stem cells as claimed by applicant. The cited art taken as a whole demonstrates a reasonable probability that the neural retina cell aggregates of Nasonkin are either identical or sufficiently similar to the claimed neural retina cell aggregates that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. Clear evidence that the neural retina cell aggregates of Nasonkin does not possess a critical characteristic that is possessed by the claimed neural retina cell aggregates (for example, that neural retina cell aggregates of Nasonkin has expression of all non-neural retina-related cell-related gene that are brain and spinal cord tissue marker genes or are eyeball related tissue marker genes) would advance prosecution and might permit allowance of claims to applicants' neural retina cell aggregates.
Therefore, the invention reference anticipates the claimed subject matter or the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Nasonkin et al. (WO 2019/028088 A1) (ref. of record) in view of Singh et al. (Stem Cells and Development, 2015).
With respect to claim 1, Nasonkin teaches a retinal patch (a complex) containing multiple pieces of stem cell derived tissues (two or more cell aggregates) on a carrier or scaffold (matrix) (abstract and pg. 3-4 bridging para.). Nasonkin further teaches the stem cell derived tissues of retinal patch containing neural retina (pg. 3 para. 1-2 and 4). Nasonkin teaches neural retina is a transplant neural retina sheet (pg. 19 para. 2).
With respect to claim 1 (1), Nasonkin teaches the neural retina is derived from a pluripotent stem cells (abstract, pg. 3-4 bridging para., pg. 14-15 bridging para and pg. 19 para. 1).
With respect to claim 1 (2), Nasonkin teaches the neural retina has a three-dimensional structure (pg. 15 last para.).
With respect to claim 1 (3), Nasonkin teaches the neural retina has a neural retinal layer having a plurality of layer structures including a photoreceptor layer and an inner layer (pg. 15 para. 2).
With respect to claim 1 (4), Nasonkin teaches the photoreceptor layer comprising one or more cells selected from the group consisting of a photoreceptor progenitor cell and a photoreceptor cell (pg. 15 para. 2).
With respect to claim 1 (5), Nasonkin teaches the inner layers containing retinal ganglion cells and layer of second-order retinal neurons corresponding to the inner nuclear layer of the retina (bipolar cells and amacrine cells) (pg. 15 para. 2).
Even though Nasonkin does not explicitly teach the retina surface of the neural retinal layer having an apical surface as recited in claim 1 (6), Nasonkin teach a neural retinal layer which would have an out surface. As explained in the rejections under 35 U.S.C. § 112 (b) the phrase is being interpreted to mean that the neural retinal layer has an outer surface.
With respect to claim 1 (7), Nasonkin teaches that the inner layer being present inside the photoreceptor layer present along the apical surface (pg. 15 para. 2 and Fig. 1E and Fig. 5B-D).
With respect to claim 1 (8), Nasonkin teaches the area of the neural retinal layer being 50% or more with respect to the total area of the surface of the transplant neural retina sheet (Fig. 1E).
With respect to claim 1 (9), Nasonkin teaches 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, and (Fig. 1E).
With respect to claim 1 (10), Nasonkin teaches the expression of neural retina-related cell-related genes, RCVRN and CALB2, in the transplant neural retina sheet (pg. 18 last para.).
Nasonkin does not test the cell aggregates for the expression of non-neural retina-related cell-related gene and does not teach the expression of non-neural retina-related cell-related gene being not found in the transplant neural retina sheet as recited in claim 1 (10). Similarly, Nasonkin does not teach the non-neural retina-related cell-related gene comprising one or more genes selected from the group consisting of brain and spinal cord tissue marker gene and eyeball-related tissue marker gene as recited in claim 10. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' generated neural retina cell aggregates differ, and if so to what extent, from the neural retina cell aggregates of Nasonkin. The neural retina cell aggregates of Nasonkin are the same or similar because they are being derived from pluripotent stem cells as claimed by applicant. The cited art taken as a whole demonstrates a reasonable probability that the neural retina cell aggregates of Nasonkin are either identical or sufficiently similar to the claimed neural retina cell aggregates that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. Clear evidence that the neural retina cell aggregates of Nasonkin does not possess a critical characteristic that is possessed by the claimed neural retina cell aggregates (for example, that neural retina cell aggregates of Nasonkin has expression of all non-neural retina-related cell-related gene that are brain and spinal cord tissue marker genes or are eyeball related tissue marker genes) would advance prosecution and might permit allowance of claims to applicants' neural retina cell aggregates.
Nasonkin is silent with respect to the size of the graft and the cell aggregates and does not the cell aggregates have a major axis of 600 µm to 2500 µm, and the two or more cell aggregates are arranged in a row in the matrix as recited in claim 2.
However, Singh teaches a similar transplant retina sheet or aggregate containing photoreceptor layer and inner layer where the minor axis is 1 mm (1000 µm) and based on the scale the major axis would be between approximately 4-5 mm (4000-5000 µm) (Fig. 9). Singh teaches the 3D retinal tissue aggregates are 150-300 somas in diameter and 8-12 somas in thickness (pg. 38 lines 24-26). Additionally, Singh teaches routine fetal retina grafting is about 2 mm2, transplant size for human patients is 2-5 mm2, and their rat transplants were about 1-1.5 x 0.6 mm (pg. 2790 Col. 2 para. 3). Singh further teaches grafting pieces hESC-derived retinal tissue together to form larger grafts (arranged in a row) (pg. 2790 Col. 2 para. 3).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the transplant neural retina sheet taught by Nasonkin so that the cell aggregates have a major axis of 600 µm to 2500 µm, and the two or more cell aggregates are arranged in a row in the matrix for the benefit of adjusting the size depending on the use of the transplant neural retina sheet and the needed size for the patient. It would have been obvious to one of ordinary skill in the art to modify the transplant neural retina sheet taught by Nasonkin so that the cell aggregates have a major axis of 600 µm to 2500 µm, and the two or more cell aggregates are arranged in a row in the matrix, since similar transplant neural retina sheets were known with such dimensions and arrangements as taught by Singh. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in modify the size of the transplant neural retina sheet, since it was known in the art to be adjusted according to need as taught by Singh.
Therefore, the invention reference anticipates the claimed subject matter or the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Nasonkin et al. (WO 2019/028088 A1) (ref. of record) in view of Gandhi et al. (Acta Biomaterialia, 2018).
With respect to claim 1, Nasonkin teaches a retinal patch (a complex) containing multiple pieces of stem cell derived tissues (two or more cell aggregates) on a carrier or scaffold (matrix) (abstract and pg. 3-4 bridging para.). Nasonkin further teaches the stem cell derived tissues of retinal patch containing neural retina (pg. 3 para. 1-2 and 4). Nasonkin teaches neural retina is a transplant neural retina sheet (pg. 19 para. 2).
With respect to claim 1 (1), Nasonkin teaches the neural retina is derived from a pluripotent stem cells (abstract, pg. 3-4 bridging para., pg. 14-15 bridging para and pg. 19 para. 1).
With respect to claim 1 (2), Nasonkin teaches the neural retina has a three-dimensional structure (pg. 15 last para.).
With respect to claim 1 (3), Nasonkin teaches the neural retina has a neural retinal layer having a plurality of layer structures including a photoreceptor layer and an inner layer (pg. 15 para. 2).
With respect to claim 1 (4), Nasonkin teaches the photoreceptor layer comprising one or more cells selected from the group consisting of a photoreceptor progenitor cell and a photoreceptor cell (pg. 15 para. 2).
With respect to claim 1 (5), Nasonkin teaches the inner layers containing retinal ganglion cells and layer of second-order retinal neurons corresponding to the inner nuclear layer of the retina (bipolar cells and amacrine cells) (pg. 15 para. 2).
Even though Nasonkin does not explicitly teach the retina surface of the neural retinal layer having an apical surface as recited in claim 1 (6), Nasonkin teach a neural retinal layer which would have an out surface. As explained in the rejections under 35 U.S.C. § 112 (b) the phrase is being interpreted to mean that the neural retinal layer has an outer surface.
With respect to claim 1 (7), Nasonkin teaches that the inner layer being present inside the photoreceptor layer present along the apical surface (pg. 15 para. 2 and Fig. 1E and Fig. 5B-D).
With respect to claim 1 (8), Nasonkin teaches the area of the neural retinal layer being 50% or more with respect to the total area of the surface of the transplant neural retina sheet (Fig. 1E).
With respect to claim 1 (9), Nasonkin teaches 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, and (Fig. 1E).
With respect to claim 1 (10), Nasonkin teaches the expression of neural retina-related cell-related genes, RCVRN and CALB2, in the transplant neural retina sheet (pg. 18 last para.).
Nasonkin does not test the cell aggregates for the expression of non-neural retina-related cell-related gene and does not teach the expression of non-neural retina-related cell-related gene being not found in the transplant neural retina sheet as recited in claim 1 (10). Similarly, Nasonkin does not teach the non-neural retina-related cell-related gene comprising one or more genes selected from the group consisting of brain and spinal cord tissue marker gene and eyeball-related tissue marker gene as recited in claim 10. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' generated neural retina cell aggregates differ, and if so to what extent, from the neural retina cell aggregates of Nasonkin. The neural retina cell aggregates of Nasonkin are the same or similar because they are being derived from pluripotent stem cells as claimed by applicant. The cited art taken as a whole demonstrates a reasonable probability that the neural retina cell aggregates of Nasonkin are either identical or sufficiently similar to the claimed neural retina cell aggregates that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. Clear evidence that the neural retina cell aggregates of Nasonkin does not possess a critical characteristic that is possessed by the claimed neural retina cell aggregates (for example, that neural retina cell aggregates of Nasonkin has expression of all non-neural retina-related cell-related gene that are brain and spinal cord tissue marker genes or are eyeball related tissue marker genes) would advance prosecution and might permit allowance of claims to applicants' neural retina cell aggregates.
With respect to claim 3, Nasonkin teaches the hydrogel or matrix is a HySTEM hydrogel which is composed of both hyaluronan and gelatin (pg. 20 para. 1). However, Nasonkin does not teach the complex where the matrix is gelatin or a fibrin gel as recited in claim 3.
However, Gandhi teaches retinal pigment transplants including a fibrin hydrogel as a support material for transplantation (abstract). Gandhi teaches the advantages of the fibrin hydrogels are that the form into a mechanically rigid support that allows for easy manipulation with standard surgical instruments, the rate of degradation can be controlled, and it is xeno-free (abstract and pg. 135 Col. 2 para. 2). Gandi further teaches that fibrin can be formed in a variety of shapes and sizes with mechanical stiffness and degradation properties appropriate for RPE delivery (pg. 145 last para.).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the transplant neural retina sheet taught by Nasonkin so that the matrix is fibrin for the benefits of having a suitable support material that is easily manipulated and which is xeno-free as taught by Gandhi. It would have been obvious to one of ordinary skill in the art to modify the transplant neural retina sheet taught by Nasonkin so that the matrix is fibrin, since similar retinal transplants were known use fibrin as taught by Gandhi. Such a modification merely involves the substitution of one known matrix for another for the a retinal transplant tissue. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success of modifying the matrix of Nasonkin to be fibrin, since fibrin was known to be used successfully in other retinal grafts according to need as taught by Gandhi.
Therefore, the invention reference anticipates the claimed subject matter or the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632