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 .
1. Claims 1 – 7 are pending and under consideration.
Priority
2. This application claims domestic benefit to application PCT/JP2023/003688 filed 02/06/2023 and foreign priority to application JP 2022-017547 filed 02/07/2022.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 06/11/2025 and 11/20/2024are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
4. The use of the term NeuroBasal, Knockout, Glutamax, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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.
Claim Objections
5. Claim 5 is objected to because of the following informalities: “a step of” in lines 3 and 4 should be deleted because it is redundant. Appropriate correction is required.
6. Claim 5 is objected to because of the following informalities: in line 3, “an aggregate” should read “aggregates” for consistency with recitation of “aggregates” in line 4. Appropriate correction is required.
7. Claim 5 is objected to because of the following informalities: in line 4, “an RPE cell induction medium” should read “the medium” to clarify this is the same medium recited in claim 1. Appropriate correction is required.
8. Claim 6 is objected to because of the following informalities: in line 1, “an RPE cell induction medium” should read “the medium” to clarify this is the same medium recited in claim 1. Appropriate correction is required.
Claim Interpretation
9. For the purpose of applying prior art, claim 1 is interpreted as a method comprising a single active step of culturing a pluripotent stem cell in a medium comprising an E-cadherin inhibitor.
10. For the purpose of applying prior art, “E-cadherin inhibitor” of claim 1 is interpreted to include antibodies against E-cadherin and E-cadherin inhibiting peptides based on Applicant’s specification at para. 0024.
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.
(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.
11. Claim(s) 1, 2, 5, and 7 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kinooka (WO-2018117110-A1; Filed 12/19/2017; Published 06/28/2018), hereinafter Kinooka which is cited on the IDS filed 11/20/2024. U.S. Patent 11795438B2 is used as the English translation of Kinooka.
Claim 1 recites a method for producing a retinal pigment epithelial (RPE) cell, comprising
promoting differentiation induction from a pluripotent stem cell into an RPE cell by culturing the
pluripotent stem cell in a medium comprising an E-cadherin inhibitor.
Regarding claims 1, 2, and 7, Kinooka teaches a method of culturing (claim 1) induced pluripotent stem cells (claim 2) in a medium comprising hemagglutinin (“E-cadherin inhibitor” of claim 1 and “hemagglutinin” of claim 7) (col. 7 – 8).
Regarding claim 5, Kinooka teaches forming aggregates of pluripotent stem cells (step (1)) and culturing the aggregates in the medium comprising hemagglutinin (“E-cadherin inhibitor” and step (2)) (col. 7, lines 45 – 67; col. 8, lines 37 – 67; col. 9, lines 3 – 12 and 40 – 45; col. 10, lines 3 – 15).
Therefore, Kinooka anticipates claims 1, 2, 5, and 7.
12. Claim(s) 1 – 3 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Agulnick (WO-2009041984-A1; Filed 10/05/2007; Published 04/02/2009), hereinafter Agulnick which is cited on the IDS filed 11/20/2024.
Claim 1 recites a method for producing a retinal pigment epithelial (RPE) cell, comprising
promoting differentiation induction from a pluripotent stem cell into an RPE cell by culturing the
pluripotent stem cell in a medium comprising an E-cadherin inhibitor.
Regarding claims 1 – 3, Agulnick teaches a method of culturing (claim 1) human embryonic stem cells (claim 2) in a medium comprising anti-human E-cadherin antibodies (“E-cadherin inhibitor” of claim 1) and activin (“differentiation inducer” of claim 3) (page 35 – 36, para. 00132; page 37, para. 00135).
Therefore, Agulnick anticipates claims 1 – 3.
13. Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Mohamet (WO-2014072720-A2; Filed 10/05/2007; Published 04/02/2009), hereinafter Mohamet which is cited on the IDS filed 11/20/2024.
Claim 1 recites a method for producing a retinal pigment epithelial (RPE) cell, comprising
promoting differentiation induction from a pluripotent stem cell into an RPE cell by culturing the
pluripotent stem cell in a medium comprising an E-cadherin inhibitor.
Regarding claims 1 and 2, Mohamet teaches a method of culturing (claim 1) human embryonic stem cells and human induced pluripotent stem cells (claim 2) in a medium comprising an E-cadherin inhibiting peptide or an E-cadherin neutralizing antibody (“E-cadherin inhibitor” of claim 1) (page 24, para. 2; page 28, para. 2; page 31, para. 2 and last para.; page 32, para. 3 – 4).
Therefore, Mohamet anticipates claims 1 and 2.
14. Claim(s) 1 – 3 and 7 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kinooka-207 (WO-2014104207-A1; Filed 12/26/2013; Published 07/03/2014), hereinafter Kinooka-207 which is cited on the IDS filed 11/20/2024. U.S. Patent 9822344 is used as the English translation of Kinooka-207.
Claim 1 recites a method for producing a retinal pigment epithelial (RPE) cell, comprising
promoting differentiation induction from a pluripotent stem cell into an RPE cell by culturing the
pluripotent stem cell in a medium comprising an E-cadherin inhibitor.
Regarding claims 1 – 3 and 7, Kinooka-207 teaches a method of culturing (claim 1) human iPS cells (claim 2) in a medium comprising hemagglutinin (“E-cadherin inhibitor” of claim 1 and “hemagglutinin” of claim 7) and bFGF (“differentiation inducer” of claim 3) (col. 11, lines 14 – 67; col. 12, lines 1 – 10; col. 17, lines 1 – 39). Kinooka-207 teaches hemagglutinin is an E-cadherin inhibitor (Table 1).
Therefore, Kinooka-207 anticipates claims 1 – 3 and 7.
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.
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.
15. Claim(s) 1 – 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osakada (Osakada, Fumitaka, et al. Journal of cell science 122.17 (2009): 3169-3179.), hereinafter Osakada in view of Mohamet (WO-2014072720-A2; Filed 10/05/2007; Published 04/02/2009), hereinafter Mohamet which is cited on the IDS filed 11/20/2024.
Regarding claim 1 – 4 and 6, Osakada teaches a method of culturing (claim 1) hES cells and hiPS cells (claim 2) with CKI-7 (“differentiation inducer” of claim 3; “Wnt signal inhibitor” of claims 4 and 6) and SB-431542 (“differentiation inducer” of claim 3; “Nodal signal inhibitor” of claims 4 and 6) to produce RPE cells (page 3170, left col. para. 3 and right col. last para.; page 3171, left col. para. 1 and right col. para. 1; Figure 2; page 3172, left col. and right col.; page 3173, right col. para. 2; page 3174, left col. para. 2; page 3176, left col. para. 3 – 6 and right col. para. 1). Osakada does not teach the medium comprises an E-cadherin inhibitor of claim 1.
Regarding claim 5, Osakada teaches forming clumps of hES and hiPS cells and culturing the aggregates with CKI-7 and SB431542 (Figure 2A; page 3170, right col. last para.; page 3173, right col. para. 2; page 3176, left col. para. 3 – 4 and right col. para. 2). Osakada does not teach the medium comprises an E-cadherin inhibitor of step (2).
Osakada does not teach the medium comprises an E-cadherin inhibitor of claim 1 and step (2) of claim 5. However, Osakada teaches SB431542 increased expression levels of some downstream components of Notch signaling raising the possibility that non-specific effects of SB431542 might affect ES cell differentiation (page 3175, left col. last para.). Osakada teaches identification of specific inhibitors will contribute to establishment of efficient and selective differentiation methods (page 3175, right col. para. 1). Osakada teaches photoreceptor loss in retinal degeneration is the major cause of blindness and cell transplantation of photoreceptors and/or RPE cells is one of the most promising therapeutic strategies for incurable retinal degenerative diseases (page 3175, left col. para. 1). Osakada teaches transplantation of ES cell-derived RPE has been reported to improve visual function in RPE degeneration diseases such as age-related macular degeneration (page 3169, right col. para. 2). Osakada teaches if photoreceptor and/or RPE cells could be differentiated from human ES cells or iPS cells under defined conditions, and the safety of their transplantation could be ensured, this approach would represent enormous potential for therapeutic treatment of retinal degeneration (page 3169, right col. para. 2). Osakada teaches retinal differentiation methods using chemical compounds are ideal for clinical applications (page 3175, left col. para. 1). Osakada teaches several lines of evidence indicate that Wnts and Nodal inhibit neural commitment in ES cells, and CKI-7 and SB431542 treatment promote neural differentiation of hES and hiPS cells (page 3170, left col. last para. and right col. para. 1 – 2; page 3171, right col. para. 1 – 2). Osakada teaches following neural tube formation in vertebrates, progenitors in the optic vesicle and the optic cup will give rise to the RPE (page 3171, right col. para. 3). Therefore, Osakada teaches the method induces neural differentiation to RPE.
Regarding “E-cadherin inhibitor” of claims 1 and 5, Mohamet teaches a method of culturing pluripotent stem cells with an E-cadherin inhibitor to produce neural lineages in high proportions (95% or more of total cell numbers) (page 2, last para.; page 3, para. 1). Mohamet teaches the method gives rise to neural precursors and/or neural cells that have high purity (page 3, para. 2). Mohamet teaches the E-cadherin inhibitor retards differentiation along the majority of cell lineages, but does not retard differentiation into neural precursor cells (page 4, para. 4). Mohamet teaches a method of culturing human embryonic stem cells and human induced pluripotent stem cells (claim 2) in a medium comprising an E-cadherin inhibiting peptide or an E-cadherin neutralizing antibody (“E-cadherin inhibitor” of claim 1) (page 24, para. 2; page 28, para. 2; page 31, para. 2 and last para.; page 32, para. 3 – 4).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of Osakada regarding a method of culturing pluripotent stem cells in a medium comprising CKI-7 and SB431542 to induce neural differentiation to produce RPE with the teachings of Mohamet regarding a method of culturing pluripotent stem cells with an E-cadherin inhibitor to produce neural lineage cells in high proportions and high purity to arrive at the claimed method for producing a retinal pigment epithelial (RPE) cell, comprising promoting differentiation induction from a pluripotent stem cell into an RPE cell by culturing the pluripotent stem cell in a medium comprising an E-cadherin inhibitor. One would have been motivated to combine the teachings of Osakada and Mohamet to improve the method of Osakada to produce high purity RPE for treating RPE degeneration diseases as Osakada teaches SB431542 increased expression levels of some downstream components of Notch signaling raising the possibility that non-specific effects of SB431542 might affect ES cell differentiation and Osakada teaches identification of specific inhibitors will contribute to establishment of efficient and selective differentiation methods and Osakada teaches if photoreceptor and/or RPE cells could be differentiated from human ES cells or iPS cells under defined conditions, and the safety of their transplantation could be ensured, this approach would represent enormous potential for therapeutic treatment of retinal degeneration and Osakada teaches retinal differentiation methods using chemical compounds are ideal for clinical applications. One would have a reasonable expectation of success in combining the teachings as Mohamet teaches culturing pluripotent stem cells with an E-cadherin inhibitor produces neural lineages in high proportions (95% or more of total cell numbers) that have high purity and Mohamet teaches the E-cadherin inhibitor retards differentiation along the majority of cell lineages, but does not retard differentiation into neural precursor cells.
16. Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osakada (Osakada, Fumitaka, et al. Journal of cell science 122.17 (2009): 3169-3179.), hereinafter Osakada in view of Mohamet (WO-2014072720-A2; Filed 10/05/2007; Published 04/02/2009), hereinafter Mohamet which is cited on the IDS filed 11/20/2024 as applied to claims 1 – 6 above, and further in view of Kinooka-207 (WO-2014104207-A1; Filed 12/26/2013; Published 07/03/2014), hereinafter Kinooka-207 which is cited on the IDS filed 11/20/2024. U.S. Patent 9822344 is used as the English translation of Kinooka-207.
Osakada in view of Mohamet make obvious the limitations of claim 1 as set forth above. Mohamet teaches culturing with E-cadherin inhibitory peptides and an E-cadherin neutralizing antibody (page 24, para. 2; page 31, para. 2). Mohamet does not teach hemagglutinin but teaches proteins or protein derivatives including naturally occurring proteins able to bind E-cadherin and thereby prevent its biological activity may be used in the method (page 13, para. 1). However, Osakada teaches SB431542 increased expression levels of some downstream components of Notch signaling raising the possibility that non-specific effects of SB431542 might affect ES cell differentiation (page 3175, left col. last para.). Osakada teaches identification of specific inhibitors will contribute to establishment of efficient and selective differentiation methods (page 3175, right col. para. 1). Oksada teaches culturing hiPS cells with CKI-7 and SB-431542 to produce RPE cells (page 3170, left col. para. 3 and right col. last para.; page 3171, left col. para. 1 and right col. para. 1; Figure 2; page 3172, left col. and right col.; page 3173, right col. para. 2; page 3174, left col. para. 2; page 3176, left col. para. 3 – 6 and right col. para. 1). Osakada teaches if photoreceptor and/or RPE cells could be differentiated from human ES cells or iPS cells under defined conditions, and the safety of their transplantation could be ensured, this approach would represent enormous potential for therapeutic treatment of retinal degeneration (page 3169, right col. para. 2). Osakada teaches retinal differentiation methods using chemical compounds are ideal for clinical applications (page 3175, left col. para. 1). Mohamet teaches a method of culturing pluripotent stem cells with an E-cadherin inhibitor to produce neural lineages in high proportions (95% or more of total cell numbers) (page 2, last para.; page 3, para. 1). Mohamet teaches the method gives rise to neural precursors and/or neural cells that have high purity (page 3, para. 2). Mohamet teaches the E-cadherin inhibitor retards differentiation along the majority of cell lineages, but does not retard differentiation into neural precursor cells (page 4, para. 4).
Kinooka-207 teaches a method of culturing human iPS cells in a medium comprising hemagglutinin which inhibits E-cadherin (col. 11, lines 14 – 67; col. 12, lines 1 – 10; col. 17, lines 1 – 39; Table 1). Kinooka-207 teaches cells deviated from the undifferentiated state called deviated cells spontaneously emerge when culturing iPS cells and culturing with hemagglutinin can remove deviated cells (col. 1, lines 17 – 23; col. 2, lines 10 – 15; col. 6, lines 20 – 47).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of Osakada regarding a method of culturing pluripotent stem cells in a medium comprising CKI-7 and SB431542 to induce neural differentiation to produce RPE with the teachings of Mohamet regarding a method of culturing pluripotent stem cells with an E-cadherin inhibitor to produce neural lineage cells in high proportions and high purity with the teachings of Kinooka-207 regarding hemagglutinin is an E-cadherin inhibitor and culturing iPS cells with hemagglutinin can remove deviated cells to arrive at the claimed method wherein the E-cadherin inhibitor is hemagglutinin. One would have been motivated to combine the teachings of Osakada, Mohamet, and Kinooka-207 to improve the method of Osakada to produce high purity RPE for treating RPE degeneration diseases as Osakada teaches SB431542 increased expression levels of some downstream components of Notch signaling raising the possibility that non-specific effects of SB431542 might affect ES cell differentiation and Osakada teaches identification of specific inhibitors will contribute to establishment of efficient and selective differentiation methods and Osakada teaches if photoreceptor and/or RPE cells could be differentiated from human ES cells or iPS cells under defined conditions, and the safety of their transplantation could be ensured, this approach would represent enormous potential for therapeutic treatment of retinal degeneration and Osakada teaches retinal differentiation methods using chemical compounds are ideal for clinical applications. One would have a reasonable expectation of success in combining the teachings as both Mohamet and Kinooka-207 teach E-cadherin inhibitors can remove deviated cells from iPS cultures and Mohamet teaches the E-cadherin inhibitor does not retard differentiation into neural precursor cells and Mohamet teaches culturing pluripotent stem cells with an E-cadherin inhibitor produces neural lineages in high proportions (95% or more of total cell numbers) that have high purity and Oksada teaches CKI-7 and SB431542 induces neural differentiation of iPS cells to produce RPE.
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.
17. Claim 1 – 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 – 10 and 15 – 18 of copending Application No. 18836633 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and reference claims are drawn to methods of differentiating pluripotent stem cells by culturing with an E-cadherin inhibitor.
Instant claim 1 maps to reference claim 6 because both recite “culturing the pluripotent stem cell in a medium comprising an E-cadherin inhibitor”. Reference claim 8 is drawn to adjusting the concentration of the inhibitor while instant claim 1 broadly recites “E-cadherin inhibitor”.
Instant claim 2 maps to reference claims 9 and 17 because both require a pluripotent stem cell that is an ES cell or iPS cell that can be differentiated into one of the three germ lineages.
Instant claim 3 maps to reference claims 7 and 16 because both are drawn to the presence of a differentiation inducer present in the culture medium. Instant claims 4 and 6 further limit the differentiation inducer.
Instant claim 5 maps to reference claim 15 because both are drawn to a step (1) of forming an aggregate of pluripotent stem cells, and a step (2) of culturing the aggregates obtained in step (1) in a medium comprising an E-cadherin inhibitor.
Instant claim 7 maps to reference claims 10 and 18 because each recite “wherein the E-cadherin inhibitor is hemagglutinin”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18. Claims 1 – 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 12 of copending Application No. 19062599 in view of Mohamet (WO-2014072720-A2; Filed 10/05/2007; Published 04/02/2009), hereinafter Mohamet which is cited on the IDS filed 11/20/2024.
Reference claims 1, 5, and 6 are drawn to methods of differentiating human pluripotent stem cells to retinal pigment epithelial cells by adherent culturing on a culture substrate coated with laminin-511 E8. Reference claims 1, 5, and 6 and dependents lack culturing with an E-cadherin inhibitor of instant claim 1 and 7. Mohamet teaches a method of culturing pluripotent stem cells with an E-cadherin inhibitor to produce neural lineages in high proportions (95% or more of total cell numbers) (page 2, last para.; page 3, para. 1). Mohamet teaches the method gives rise to neural precursors and/or neural cells that have high purity (page 3, para. 2). Mohamet teaches the E-cadherin inhibitor retards differentiation along the majority of cell lineages, but does not retard differentiation into neural precursor cells (page 4, para. 4). Mohamet teaches a method of culturing human embryonic stem cells and human induced pluripotent stem cells in a medium comprising an E-cadherin inhibiting peptide or an E-cadherin neutralizing antibody (“E-cadherin inhibitor” of claim 1) (page 24, para. 2; page 28, para. 2; page 31, para. 2 and last para.; page 32, para. 3 – 4).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to have modified the methods of the reference claims to include an E-cadherin inhibitor of Mohamet because Mohamet teaches culturing pluripotent stem cells with an E-cadherin inhibitor produces neural lineages in high proportions (95% or more of total cell numbers) that have high purity and Mohamet teaches the E-cadherin inhibitor retards differentiation along the majority of cell lineages, but does not retard differentiation into neural precursor cells.
Instant claim 2 maps to reference claims 3, 4, 8, 9, 11, and 12 because all are drawn to iPS cells.
Instant claim 3 maps to reference claims 2, 7, and 10 because all are drawn to culturing with a differentiation inducer.
This is a provisional nonstatutory double patenting rejection.
19. Claims 1 – 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 17 of U.S. Patent No. 9822344. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and Patent claims are drawn to culturing pluripotent stem cells with an E-cadherin inhibitor that is hemagglutinin and the culture comprises cells deviated from an undifferentiated state.
Instant claims 1, 2, 5, and 7 map to Patent claims 1 – 17 because all are drawn to culturing pluripotent stem cells that are ES or iPS (instant claim 1,2, 5; Patent claims 2, 3, 7, 8, 9, 13, 17) with an E-cadherin inhibitor (instant claim 1; Patent claim 11) that is hemagglutinin (instant claim 7; Patent claims 1, 4, 5, 6, 11, 12, 14, 15, 16, 17). Instant claims 3, 4, and 6 map to Patent claims 10 and 16 because all are broadly drawn to culturing and Patent claims 10 and 16 recite “the culture comprises at least one cell deviated from an undifferentiated state”.
20. Claims 1 – 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 – 14 of U.S. Patent No. 11230701. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and Patent claims are drawn to culturing pluripotent stem cells with hemagglutinin.
Instant claims 1, 2, and 7 map to Patent claims 7 – 14 because all are drawn to culturing pluripotent stem cells that are ES or iPS (instant claim 1, 2; Patent claims 7, 9, 10, 11, 12, 13) with hemagglutinin (instant claim 1, 7; Patent claims 7 – 14). Instant claim 5 maps to Patent claim 12 because both are drawn to culturing pluripotent stem cell aggregates with hemagglutinin. Instant claims 3, 4, and 6 map to Patent claim 9 because all are broadly drawn to culturing and Patent claim 9 recites “a cell deviated from an undifferentiated state, the cell being a cell that has emerged or may possibly emerge during culture of a stem cell having pluripotency”.
21. Claims 1 – 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 10 of U.S. Patent No. 11492593 in view of Mohamet (WO-2014072720-A2; Filed 10/05/2007; Published 04/02/2009), hereinafter Mohamet which is cited on the IDS filed 11/20/2024.
Patent claims 1 and 6 are drawn to a method of producing a retinal pigment epithelial cell from a pluripotent stem cell comprising inducing differentiation of pluripotent stem cells on laminin-511E8. Patent claims 1 and 6 and dependents lack culturing with an E-cadherin inhibitor of instant claim 1 and 7. Mohamet teaches a method of culturing pluripotent stem cells with an E-cadherin inhibitor to produce neural lineages in high proportions (95% or more of total cell numbers) (page 2, last para.; page 3, para. 1). Mohamet teaches the method gives rise to neural precursors and/or neural cells that have high purity (page 3, para. 2). Mohamet teaches the E-cadherin inhibitor retards differentiation along the majority of cell lineages, but does not retard differentiation into neural precursor cells (page 4, para. 4). Mohamet teaches a method of culturing human embryonic stem cells and human induced pluripotent stem cells in a medium comprising an E-cadherin inhibiting peptide or an E-cadherin neutralizing antibody (“E-cadherin inhibitor” of claim 1) (page 24, para. 2; page 28, para. 2; page 31, para. 2 and last para.; page 32, para. 3 – 4).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to have modified the method of Patent claim 6 to include an E-cadherin inhibitor of Mohamet because Mohamet teaches culturing pluripotent stem cells with an E-cadherin inhibitor produces neural lineages in high proportions (95% or more of total cell numbers) that have high purity and Mohamet teaches the E-cadherin inhibitor retards differentiation along the majority of cell lineages, but does not retard differentiation into neural precursor cells.
Instant claim 2 maps to Patent claims 1 and 6 because all are drawn to pluripotent stem cells.
Instant claims 3 – 6 map to Patent claims 1 and 6 because all are drawn to differentiation of pluripotent stem cells.
22. Claims 1 – 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 5 of U.S. Patent No. 11795438. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and Patent claims are drawn to culturing pluripotent stem cells with hemagglutinin.
Instant claims 1, 2, and 7 map to Patent claims 1 – 5 because all are drawn to culturing pluripotent stem cells (instant claim 1, 2; Patent claims 1 – 5) with hemagglutinin (instant claim 1, 7; Patent claims 1 – 5). Instant claim 5 maps to Patent claim 1 because both are drawn to culturing pluripotent stem cell in a dispersed state with hemagglutinin, where the Patent defines “dispersed state” as in a state where not all cells are single cells (col. 5, lines 22 – 26). Instant claims 3, 4, and 6 map to Patent claim 1 because all are broadly drawn to culturing.
Conclusion
No claims allowed.
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/ZANNA MARIA BEHARRY/Examiner, Art Unit 1632
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