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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/16/2025 has been entered.
Claims 1-14 and 16, of record 10/16/2025, are pending and subject to prosecution. Claims 1-11 and 16 are amended. Claim 15 is cancelled.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1-2, 4, 8-10, and 15 under 35 U.S.C. 102(a)(1) over Lakowski et al. (Stem Cells, 2018), as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997) and Wiley et al. (Scientific Reports, 2016):
RE: Rejection of claims 1-2, 4-5, 8-10, and 15 under 35 U.S.C. 103 over Lakowski et al. (Stem Cells, 2018), as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997) and Wiley et al. (Scientific Reports, 2016):
RE: Rejection of claims 1-2, 4-5, 7-10, and 15 under 35 U.S.C. 103 over Lakowski et al. (Stem Cells, 2018), as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997) and Wiley et al. (Scientific Reports, 2016), in view of Yanai et al. (Methods in Molecular Biology, 2015):
RE: Rejection of claims 1-2, 4-5, 8-13, and 15 under 35 U.S.C. 103 over Lakowski et al. (Stem Cells, 2018), as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997) and Wiley et al. (Scientific Reports, 2016), in view of Ioannis (WO 2017091844 A1):
RE: Rejection of claims 1-2, 4-5, and 8-15 under 35 U.S.C. 103 over Lakowski et al. (Stem Cells, 2018) as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997) and Wiley et al. (Scientific Reports, 2016), in view of Ioannis (WO 2017091844 A1), and further in view of Mandai et al. (US 12285543 B2):
The cancellation of claim 15 renders the rejections thereto moot.
The applicant asserts that the cells taught by Lakowski et al., evidenced by Belecky-Adams et al., cannot anticipate the claimed cells (Applicant Remarks, page 4). The applicant asserts that “the Examiner cannot pick and choose from the literature” for evidence that the cells of Lakowski et al. would have particular makers expressed (Applicant Remarks, page 4). The applicant asserts that, for the purposes of markers, the human cells of Lanza et al. are more comparable to the claimed cells than the non-human cells taught by Belecky-Adams et al., Canto Soler et al., Remez et al., and Farhy et al. (Applicant Remarks, page 5). Further, the applicant asserts that the prior art does not read on the instant claims, which have been amended to recite a pharmaceutical composition, rather than a composition (Applicant Remarks, page 5).
The applicant appears to be arguing that photoreceptor precursor cells should express Pax6 and that the instant invention is distinct in that the photoreceptor precursor cells of the composition do not express Pax6, or relatively few (less than 10%) express Pax6. In order to refute the Office’s finding that Pax6 is not normally expressed in photoreceptor precursor cells, the applicant has pointed to the published patent application of Lanza et al., which is noted as not being peer-reviewed.
The applicant’s arguments have been fully considered but are not found persuasive. The use of multiple reference 102 rejections are proper to show that a characteristic not disclosed in a primary reference is inherent (2132.01 III). "To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill." Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991).
The rejections of record are based on the teachings of Lakowski et al., wherein aggregates of photoreceptor precursor cells are prepared. Lakowski et al. do not expressly teach whether Pax6 is expressed in photoreceptor precursor cells, therefore, the teachings of Belecky-Adams et al. are relied upon for demonstrating that Pax6 is not inherently expressed in photoreceptor precursor cells. The teachings of Canto Soler et al., Remez et al., and Farhy et al. also show that Pax6 is not expressed in photoreceptor precursor cells. While these evidentiary references do rely on chick and mouse models, the use of animal models has been well-established in the field of eye development, and Nishina et al. teach that Pax6 expression patterns in developing human eyes are similar to those in murine and chick eyes (See page 726, col. 1, full ¶1). The human photoreceptor precursor cells taught by Lakowski et al. are thus reasonably considered to be Pax6-negative, in light of the breadth of the prior art.
Regarding the amendment of the claims to require, specifically, a pharmaceutical composition, Lawokski et al. teach the transplantation of human photoreceptor precursor cells into mice that model retinal degeneration (See page 712, col. 1, full ¶1-2). A composition of cells used for therapeutic transplantation reads on “pharmaceutical”.
The rejections are maintained in modified form in order to address the amendment to require a pharmaceutical composition comprising human cells.
RE: Provisional rejection of claims 1-14 on the ground of nonstatutory double patenting over claims 109, 113-115, 117-123, 125, 138, and 140 of co-pending Application No. 18824380:
Applicants are reminded that 37 CFR 1.111 requires that replies by applicant or patent owner must reply to every ground of objection and rejection in the prior Office Action. Only objections or requirements as to form not necessary to further consideration of the claims may be requested to be held in abeyance until allowable subject matter is indicated. Non-statutory double patenting rejections may not be held in abeyance. See MPEP 714.02. Applicants did not traverse the NSDP rejection. The rejection is maintained in modified form to address amended limitations.
RE: Rejection of claims 1-2, 8, 10, and 15 on the ground of nonstatutory double patenting over claims 1 and 22-23 of US Patent No. 12110503, evidenced by Lakowski et al. (Stem Cells, 2018), Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997) and Wiley et al. (Scientific Reports, 2016):
The cancellation of claim 15 renders the rejection thereto moot.
The terminal disclaimer filed on 10/16/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 12110503 has been reviewed and is accepted. The terminal disclaimer has been recorded. The rejection is withdrawn.
New/Maintained Objections/Rejections
Claim Interpretation
The instant claims have been amended to recite a pharmaceutical composition. The adjective “pharmaceutical” is not defined by the instant specification. The broadest reasonable interpretation of this limitation is therefore considered to be any composition that can be administered to a subject for a medicinal or therapeutic purpose.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
In line 2 of claim 1 and lines 2-4 of claim 6, the word “human” should be inserted in front of “PRPs”.
Appropriate correction is required.
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.
Claims 1-2, 4, and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lakowski et al. (Stem Cells, 2018), of record, as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997), of record, and further evidenced by Wiley et al. (Scientific Reports, 2016), of record.
Regarding claims 1-2, 4, and 8-10: Lakowski et al. teach the generation of photoreceptor precursor cells from human ESCs and iPSCs (which reads on “human photoreceptor precursor cells”) (See Abstract). The stem cells were grown as aggregates/embryoid bodies on a laminin-coated surface (which reads on “adhered onto an extracellular matrix) and differentiated into retinal cells (See page 710, col. 2, full ¶3). The differentiated cells were transplanted (which necessarily reads on “a pharmaceutical composition” and “a pharmaceutically acceptable carrier”) into the subretinal space of retinal degeneration model mice (See page 719, col. 1, full ¶1). Photoreceptor precursor cells in the aggregates were identified on the basis of Crx and recoverin co-expression (See page 715, col. 1, ¶1 and fig. 2-4), indicating that all photoreceptor precursor cells would necessarily be recoverin-positive (which reads on at least 90% of the PRPs express RCVRN”). Lakowski et al. teach that the cell aggregates express Pax6 but are silent on Pax6 and TUBB3 expression in photoreceptor precursor cells.
Belecky-Adams et al. is cited as evidence showing that Pax6 is not detected in prospective photoreceptors (which reads on “less than 10% of the PRPs express PAX6”) (See Abstract and page 1297, col. 2, full ¶1-3). Thus, the cells of Lakowski et al. necessarily read on “less than 10% of the PRPs express PAX6”.
Wiley et al. is cited as evidence showing the production of iPSC-derived photoreceptor precursor cells (See Abstract). Organoids comprising photoreceptor precursor cells show expression of recoverin, and nearly every cell appears to stain with the anti-beta-tubulin III antibody Tuj1 (which reads on “at least 90% of the PRPs express TUBB3”) (See page 5, full ¶1 and fig. 3E-F). Thus, the cells of Lakowski et al. necessarily comprise photoreceptor precursor cells wherein “at least 90% of the PRPs express TUBB3” as claimed.
Claim Rejections - 35 USC § 103
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 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 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 1-2, 4-5, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lakowski et al. (Stem Cells, 2018), of record, as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997), of record, and further evidenced by Wiley et al. (Scientific Reports, 2016), of record.
The teachings of Lakowski et al., Belecky-Adams et al., and Wiley et al., are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 5: Following the discussion of claims 1-2, 4, and 8-10, Lakowski et al., as evidenced by Belecky-Adams et al. and Wiley et al., teach photoreceptor precursor aggregates but do not teach expression of Ki67 in the cells. However, Lakowski et al. teach that cells can be sorted for negative selection on the basis of Ki67 expression (See fig. 5). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the aggregates of Lakowski, as evidenced by Belecky-Adams et al., and Wiley et al., to exclude Ki67-positive cells using flow cytometry. One would be motivated to make this modification because Lakowski et al. teach that mitotically-active cells, as indicated by Ki67 expression, present a high safety risk when transplanted (See page 718, col. 2, full ¶1 and page 719, col. 1, ¶1), and such a modification could be readily made.
Claims 1-2, 4-5, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lakowski et al. (Stem Cells, 2018), of record, as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997), of record, and further evidenced by Wiley et al. (Scientific Reports, 2016), of record, in view of Yanai et al. (Methods in Molecular Biology, 2015), of record.
The teachings of Lakowski et al., Belecky-Adams et al., and Wiley et al., are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 7: Following the discussion of claims 1-2, 4-5, and 8-10, Lakowski et al., as evidenced by Belecky-Adams et al., teach a composition comprising photoreceptor precursors but do not teach a cryoprotectant.
Yanai et al. teach the generation of photoreceptor precursor cells originating from ESC-derived embryoid bodies (See Abstract and section 3.3.3). Yanai et al. teach that the cells can be frozen in photoreceptor precursor cell medium containing 10% DMSO (which reads on “a cryoprotectant”) for future use (See page 364, section 3.3.3).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Lakowski et al., as evidenced by Belecky-Adams et al. and Wiley et al., to comprise a photoreceptor precursor medium comprising DMSO, such as is taught by Yanai et al. One would be motivated to make this modification in order to use the cells at future timepoints. There would be a reasonable expectation of success in doing so because Yanai et al. teach that photoreceptor cells can be frozen in such a manner (See page 364, section 3.3.3).
Claims 1-2, 4-5, and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lakowski et al. (Stem Cells, 2018), of record, as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997), of record, and further evidenced by Wiley et al. (Scientific Reports, 2016), of record, in view of Ioannis (WO 2017091844 A1), of record.
The teachings of Lakowski et al., Belecky-Adams et al., and Wiley et al., are set forth in the rejections above and are incorporated herein in their entirety.
Regarding claims 11-13: Following the discussion of claims 1-2, 4-5, and 8-10, Lakowski et al., as evidenced by Belecky-Adams et al. and Wiley et al., teach the transplantation of pharmaceutical compositions comprising photoreceptor precursors in subjects with retinal disease but do not expressly teach an effective dose.
Ioannis teaches the generation of retinal cells, such as photoreceptor precursors, from stem cells for the treatment (which reads on “an effective amount”) of retinal diseases (See page 27, line 23-26). The retinal diseases include age-related macular degeneration, Stargardt’s macular dystrophy, and retinitis pigmentosa (See page 28, line 30-32 and page 29, line 1-12).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Lakowski et al., as evidenced by Belecky-Adams et al. Wiley et al., to comprise administration of the photoreceptor precursors to subjects with age-related macular degeneration, Stargardt’s macular dystrophy, and retinitis pigmentosa. One would be motivated to make this modification because Ioannis teaches that these disorders can be treated by administering cells such as photoreceptor progenitors (See page 28, line 30-32 and page 29, line 1-12), and such a modification could be readily made.
Claims 1-2, 4-5, and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lakowski et al. (Stem Cells, 2018), of record, as evidenced by Belecky-Adams et al. (Investigative Ophthalmology & Visual Science, 1997), of record, and further evidenced by Wiley et al. (Scientific Reports, 2016), of record, in view of Ioannis (WO 2017091844 A1), of record, and further in view of Mandai et al. (US 12285543 B2), of record.
The teachings of Lakowski et al., Belecky-Adams et al., Wiley et al., and Ioannis are set forth in the rejections above and are incorporated herein in their entirety.
Regarding claim 14: Following the discussion of claims 1-2, 4-5, and 8-13, Lakowski et al., as evidenced by Belecky-Adams et al. and Wiley et al., modified by Ioannis, render obvious the transplantation of photoreceptor precursors in subjects with retinal diseases but do not expressly teach the diseases as dystrophy involving rods and cones.
Mandai et al. teach modified retinal cell populations, including photoreceptor precursors, for transplantation in subjects with retinal diseases (See Abstract and col. 3, line 52-56 and 61-65). The diseases include cone-rod dystrophy (See col. 32, line 5-34).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Lakowski et al., as evidenced by Belecky-Adams et al. and Wiley et al., modified by Ioannis, to comprise administration of the photoreceptor precursors to subjects with cone-rod dystrophy. One would be motivated to make this modification because Mandai et al. teach that these disorders can be treated by administering cells such as photoreceptor progenitors (See col. 32, line 5-34), and such a modification could be readily made.
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 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 109, 113-115, 117-123, 125, 138, and 140 of co-pending Application No. 18824380 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 1 and 10-14: Co-pending claim 113 requires the composition of co-pending claim 109 wherein at least 90% of the PRPs express RCVRN. Co-pending claim 114 requires the composition of co-pending claim 109 wherein less than 10% of the PRPs express PAX6. Co-pending claim 121 requires the composition of co-pending claim 109 wherein the PRPs are in aggregate form. Co-pending claim 109 recites a composition comprising photoreceptor precursor cells wherein at least 50% of the PRPs express RCVRN and less than 15% express PAX6. Co-pending claim 125 recites a composition comprising PRPs in aggregate form and a pharmaceutically acceptable carrier (which reads on “pharmaceutical composition”).
The co-pending claims do not expressly recite human photoreceptor precursor cells. However, co-pending claim 118 recites the method of co-pending claim 123 wherein the retinal disease is AMD, Stargardt’s macular dystrophy, retinitis pigmentosa, glaucoma, retinal vascular disease, viral infection of the eye, cone dystrophy, or cone-rod and/or rod-cone dystrophy. Because these diseases are commonly observed in humans, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the instant composition to comprise human photoreceptor precursor cells for treatment in humans. Such a modification could be readily performed.
Regarding claim 2: Following the discussion of claims 1 and 10-14, co-pending claim 115 requires the composition of co-pending claim 109 wherein at least 90% of the PRPs express TUBB3. The combined limitations of the co-pending claims render obvious instant claim 2.
Regarding claim 3: Following the discussion of claims 1 and 10-14, co-pending claim 117 requires the composition of co-pending claim 109 wherein less than 1% of the PRPs express ONECUT. The combined limitations of the co-pending claims render obvious instant claim 3.
Regarding claim 4: Following the discussion of claims 1 and 10-14, co-pending claim 118 requires the composition of co-pending claim 109 wherein the PRPs express OTX2, IRBP, SUSD2, CRX, BLIMP1, NEUROD1, and/or CD171/LICAM. The combined limitations of the co-pending claims render obvious instant claim 4.
Regarding claim 5: Following the discussion of claims 1 and 10-14, co-pending claim 119 requires the composition of co-pending claim 109 wherein the PRPs do not express or have essentially no expression of TRYP1, Ki67, CRALBP, BEST1, MITF, and/or PMEL17. The combined limitations of the co-pending claims render obvious instant claim 5.
Regarding claim 6: Following the discussion of claims 1 and 10-14, co-pending claim 120 requires the composition of co-pending claim 109 wherein at least 90% of the PRPs express TUBB3 and less than 1% express ONECUT; the PRPs express OTX2, IRBP, SUSD2, CRX, BLIMP1, NEUROD1, and/or CD171/LICAM; and the PRPs do not express or have essentially no expression of TRYP1, CRALBP, BEST1, Ki67, MITF, and/or PMEL17. The combined limitations of the co-pending claims render obvious instant claim 6.
Regarding claim 7: Following the discussion of claims 1 and 10-14, co-pending claim 138 requires the composition of co-pending claim 125 further comprising a cryoprotectant. The combined limitations of the co-pending claims render obvious instant claim 7.
Regarding claim 8: Following the discussion of claims 1 and 10-14, co-pending claim 122 requires the composition of co-pending claim 109 wherein the PRPs are derived from IPSCs. The combined limitations of the co-pending claims render obvious instant claim 8.
Regarding claim 9: Following the discussion of claims 1, 7, and 10-14, co-pending claim 140 requires the composition of co-pending claim 125 wherein the composition is adhered onto an extracellular matrix or provided on a biodegradable polymer. The combined limitations of the co-pending claims render obvious instant claim 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5, 7-8, 10-11, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 93-94, 96, 107-108, and 120 of co-pending Application No. 19235357 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 1, 5, 8, 10-11, and 16: Co-pending claim 93 recites a composition comprising PRPs. Co-pending claim 94 recites the composition of co-pending claim 93, wherein the PRPs comprise at least about 90% RCVRN+ cells and less than or equal to about 7% PAX6 cells (which reads on “less than 10% of the PRPs express PAX6”), less than or equal to about 7% CHX10+ cells (which reads on “less than 10% of the human PRPs express CHX10”), and less than or equal to about 0.5% TYRP1+ cells or Ki67+cells (which reads on “do not express or have essentially no expression of TRYP1… [and/or/] Ki67”). Co-pending claim 96 recites the composition of co-pending claim 93, wherein the PRPs are derived from human PSCs or human iPSCs. Co-pending claim 107 recites a composition of PRPs suitable for grafting to a subretinal space of a subject’s eye (which reads on “pharmaceutical composition” and “administering… to the eye of a subject”). Co-pending claim 108 recites a composition comprising human PRPs and a balanced salt solution buffer supplemented with 0.2% HSA (which reads on “a pharmaceutically acceptable carrier”). The combined limitations of the co-pending claims render obvious the instant claims.
Regarding claim 7: Following the discussion of claims 1, 5, 8, 10-11, and 16, co-pending claim 120 recites a composition comprising human PRPs and a cryopreservant solution (which reads on “cryoprotectant”). The combined limitations of the co-pending claims render obvious the instant claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 3 and 6 appear to be free of the prior art. The prior art indicates that ONECUT1 is normally expressed in photoreceptor precursor cells (See Muranishi et al., fig. 4B). However, the claims are rejected under double patenting for the reasons stated above.
Conclusion
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633