DETAILED ACTION
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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 23-24, drawn to a composition comprising human retinal pigment epithelial cells, classified in C12N 5/0621.
II. Claims 25-33, drawn to a tissue culture comprising human induced pluripotent stem cells, classified in C12N 5/0606.
The inventions are independent or distinct, each from the other because:
Inventions Group I and II are directed to related product. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design, mode of operation, function and effect as the compositions are directed to two distinct cell populations. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
During a telephone conversation with Ms. Siegel on 6/18/2026 a provisional election was made without traverse to prosecute the invention of Group II, claims 25-33.
Affirmation of this election was made by applicant in the amendment filed on 6/23/2026.
Claims 23-24 have been withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
In the amendment filed on 6/23/2026, claims 1-24 have been canceled, and claims 25-33 have been considered on the merits.
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 25-33 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 25 and its dependent claims disclose “a tissue culture”. It is not clear what the scope of this term is. Generally the term “tissue culture” would encompass cells and culture medium and/or any supplements to the medium. However, the limitation disclosed in claim 25 directed to the cell density (cells/cm2) is particularly disclosed presumably based on the surface of a culture plate, indicating that these cells are adhered to a surface of a cell culture plate. Furthermore, claim 27-29 are directed to laminin or other adhesion protein in the cell culture. It is understood that these proteins are typically coated on the surface of the culture plates. It is not clear if the claimed “tissue culture” is limited to cells and medium, or the claims require any hardware as a part of the cell culture. Clarification is required.
Claim 28 is dependent on itself. As it is not clear to which claim 28 is dependent on, the claim is indefinite. Clarification is required. For search purpose, claim 28 is interpreted dependent on claim 27.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 25-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bharti et al. (WO2014/121077; IDS ref.; published on 8/7/2014)
Bharti et al. teach a method for generating retinal pigment epithelial (RPE) cells from induced pluripotent stem cells (iPSCs) (Abstract). Bharti et al. teach iPSCs are cultured in the retinal induction medium (RIM) (Example 3), and the RIM comprising CKI-7 (Wnt pathway inhibitor), SB431542 (TGFb pathway inhibitor), Noggin (BMP pathway inhibitor), IGF-1 (p.75-76). Bharti et al. teach that iPSCs are differentiated into RPE lineage (Example 2), and RPE lineage is considered to meet the retinal lineage cells that can differentiate into human RPE cells.
Regarding the cell density of about 1000-33000 cells/cm2 (claim 25), 5000-20000 cells/cm2 (claim 31), 5000-30000 cells/cm2 (claim 32) or 1000-20000 cells/cm2 (claim 33), these limitations are not considered to provide any structure to the claimed tissue culture as the unit “cells/cm2” implies that the tissue culture is in a container with a dimension, and yet the tissue culture is not particularly claimed to be adherent on a plate or any surface. As the claimed tissue culture does not require any particular device or culture ware. Still further, even if the claims are limited with a container having a dimension, the unit number of cells does not change the structure of the cells. In other words, 1 million cells in a composition would not render them patentable over 10 million cells, for example. Thus, it is considered that the cell density as claimed does not provide any specific structure to the claimed tissue culture, and therefore, any concentration of iPSCs would anticipate the claimed product.
Regarding claim 26 directed to matrix, Bharti et al. teach the use of human extracellular matrix (ECM) (p.94).
Regarding claim 27 directed to the matrix comprising a recombinant cellular adhesion protein, the term “recombinant” is interpreted as a product-by-process limitation, and the adhesion protein being produced by a process of recombinant biology. As there is no indication that the claimed recombinant adhesion protein of the ECM is structurally different from the adhesion proteins inherently present in the human ECM taught by Bharti et al., the human ECM of Bharti et al. is considered to meet the adhesion protein. It is extremely well known in the art that human ECM would inherently contain laminin, fibronectin and vitronectin.
Thus, the reference anticipates the claimed invention.
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) 25-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bharti et al. (supra) in view of Wilson et al. (2015, Fluids Barriers CNS), Nishida et al. (US2018/0010093A1; effectively filed date of 1/15/2015) and Chen et al. (2013, Cell Stem Cell)
Bharti et al. anticipate the subject matter of claims 25-29 as discussed above, and thus, render them obvious.
Regarding the cell density of iPSCs in the claimed tissue culture being 1000-33000 cells/cm2 (claim 25), 5000-20000 cells/cm2 (claim 31), 5000-30000 cells/cm2 (claim 32) or 1000-20000 cells/cm2 (claim 33), the limitation was considered non-limiting the structure of the claimed tissue culture (see above). However, if the claimed tissue culture is considered to require a culture plate and the iPSCs are cultured therein with a claimed seeding density, Bharti et al. do not particularly teach the limitation.
Nishida et al. teach a method of differentiating human iPS cells into eye-related cells including RPE (para. 22), and the seeding density of iPS cells is seeded at a seeding density of 200 to 1,500 cells/cm2, 300 to 1,000 cells/cm2, or 450 to 700 cells/cm2 on laminin 511E8 fragment coated plate (para. 141). It is noted that the foreign priority document (JP2015-006074; para. 78; English translation attached) of Nishida et al. provides support for the above teaching, and thus, Nishida et al. would be qualified as 102(a)(2) art.
It would have been obvious to a person skilled in the art to utilize the cell seeding density taught by Nishida et al. for the method of Bharti et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the method of Nishida et al. is for the same purpose of differentiating human iPSCs into RPE as the method of Bharti et al. Thus, the teachings of Nishida et al. would be used for the method of Bharti et al.
Furthermore, Wilson et al. teach a method of differentiating human pluripotent stem cells to brain microvascular endothelial cells and determined the effect of cell seeding density of hPSCs utilizing low density (10,000 cells/cm2), medium density (30,000 cells/cm2) or high density (100,000 cells/cm2) (p.4, Results; Fig. 1). Wilson et al. teach that medium density (10,000 cells/cm2) and high-density (100,000 cells/cm2) were differentiated to BMEC, but low-density yielded low BMEC and excluded from the analysis (p.7).
It would have been obvious to a person skilled in the art to utilize the cell seeding density analysis taught by Wilson et al. to determine an optimal cell seeding density of iPSCs for the method of Bharti et al. with a reasonable expectation of success. Based on the teachings of Wilson et al., one skilled in the art would recognize that the cell seeding density could be a parameter for differentiating hPSCs including hiPSCs, and thus, would utilize the various different cell density taught by Wilson et al. to determine the optimal seeding density for the method of Bharti et al.
Regarding claims 27-29, assuming arguendo even if the limitation of “recombinant cellular adhesion protein” is considered to require the protein has to be recombinant, it is extremely well known in the art that human ECM taught by Bharti et al. can be recombinantly produced according to Nishida et al. Nishida et al. teach the use of laminin or laminin fragment (para. 94; Fig.), and it is a recombinant laminin protein according to Chen et al. Chen et al. teach various considerations for human pluripotent stem cell culture including the use of ECM including recombinant vitronectin or recombinant laminin-511 (p.15).
It would have been obvious to a person skilled in the art to use recombinant ECM proteins for the method of Bharti et al. as recombinant cellular adhesion proteins are well known alternative to naturally occurring ECM proteins.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 25-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13 of U.S. Patent No. 12,065,671. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘671 patent disclose a method comprising a step of culturing iPSCs in a retinal induction medium at an initial cell density of about 1,000-33,000 cells/cm2, 5,000-30,000 cells/cm2, 5,000-20,000 cells/cm2 or 1,000-20,000 cells/cm2 to initiate differentiation of the cells into retinal lineage cells, this step would inherently produce the claimed product. The claims of the ‘671 patent disclose the contents of the retinal induction medium identical to the instant claims.
Thus, the claims of the ‘671 patent anticipate and thus, render obvious the claimed product of the instant application.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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