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
Applicant’s election without traverse of Group I in the reply filed on 05/18/2026 is acknowledged. The restriction requirement between Groups I-III is withdrawn and the groups are rejoined.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between Groups I-III as set forth in the Office action mailed on 03/25/2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim 33 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/25/2026.
Claim Objections
Claim 24 is objected to because of the following informalities: Claim 24 should read “reseeding the dissociated RPE cells” at line 2, for optimal clarity. Appropriate correction is required.
Claim Interpretation
It is noted that the terms "retinal induction medium (RIM)", "retinal differentiation medium (RDM)" "retinal medium (RM)" and "RPE maturation medium (RPE-MM)" in the claims are defined in the instant specification, and the terms are interpreted based on the definition given in the specification. The "Retinal Induction Medium (RIM)" refers herein to a growth media that comprises a WNT pathway inhibitor and a BMP pathway inhibitor and can result in the differentiation of PSCs to retinal lineage cells. The RIM also comprises a TGFb pathway inhibitor (p. 18). The "Retinal Differentiation Medium (RDM)" is defined as a medium that comprises a WNT pathway inhibitor, a BMP pathway inhibitor and a MEK (or FGF) inhibitor and differentiates retinal cells. The RDM also comprises a TGFb pathway inhibitor (p. 18). "Retinal Medium (RM)" is defined as a growth medium for the culture of retinal cells comprising Activin A and Nicotinamide (p. 19). "RPE-Maturation Medium (RPE-MM)" refers to a medium for the maturation of RPE cells comprising taurine and hydrocortisone. The RPE-MM also comprises triiodothyronine. The RPE-MM may also comprise PD0325901 or PGE2 (page 19).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 28 recites the term "primary cilium inducer" for producing mature RPE cells. The instant specification does not define the term but provides two examples of prostaglandin E2 (PGE2) and aphidicolin (p. 45). The two exemplified species for the term "primary cilium inducer" are not sufficient to represent the entire scope of the term, particularly when the term is broad, and not clearly defined.
The specification fails to describe what molecules fall into this genus and it was unknown as of Applicants’ effective filing date what molecules would have the property of “a primary cilium inducer”. The specification describes only prostaglandin E2 (PGE2) and aphidicolin. The specification does not describe any attributes of molecules in the genus and has not provided a correlation between the structures of known primary cilium inducers”. There is no evidence on the record of a relationship between the structures of any primary cilium inducers relating to the prostaglandin E2 (PGE2) and aphidicolin described in the specification, that would provide any reliable information about the structure of other members of the claimed genus.
M.P.E.P. $2163 states "To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. V. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003).
The skilled artisan cannot envision the detailed chemical structure of all of the primary cilium inducers that are encompassed by the claims, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483. In Fiddes, claims directed to mammalian FGFs were found to be unpatentable due to lack of written description for that broad class. The specification only provided the bovine sequence.
Applicant is reminded that Vas-Cath makes clear that the written description of 35 U.S.C. 112 is severable from its enablement provision [see p. 1115].
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 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 1 is unclear whether the three different culture conditions in step d are intended to each lead to each of the recited cell types (Macular, central and peripheral) or whether each culture condition leads to a different cell type. “the human RPE cells” in the last line of the claims is unclear which RPE cells are being referenced. It would appear the claim would be more clear of step d resulted in mature human RPE cells and the last line referenced “the mature human RPE cells”.
Claim 9 is unclear if additional AGN 193109 is being added or if the claim is intented to limit the amount of AGN 193109 added in claims 1,7 and 8. Claim 9 would be clear if it read, wherein the AGN 193109 is present at a concentration of 0305 to 0.4 mM.
Claim 19 is unclear because it depends from claim 2 and references step a). Step a) is in claim 1, not in claim 2. This claim 19 appears to be referencing back to 2 different claims.
The term “RPE” in claim 27 lacks clear antecedent basis.
Claims 2,3,5,7-9,11-13,15-16,19-24,27-29, 32 and 32 are unclear based on their dependency from claim 1.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 18/290,396(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 14 is drawn to a scaffold comprising cells made by the method that is recited in pending claim 1. Thus, the scaffold renders obvious the claimed method as it recites the same method with no additional, no fewer, and no different method steps.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1,2,19-21,22,31 and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-24 of copending Application No. 18/769,320 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 23 is drawn to a pharmaceutical composition comprising cells made by the method that is recited in pending claim 1. Thus, the composition renders obvious the claimed method as it recites the same method with no additional, no fewer, and no different method steps. Reference claim 24 limits how the iPSCs (pending claim 2) are cultured, which is recited in pending claim 19-21. Reference claim 24 also limits the factors added to the RD medium and the RM to those recited in pending claims 22,31 and 32 .
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The closest prior art is US20190169569 (Bharti). Bharti taught derivation of mature RPE from pluripotent stem cells by successive culture in RIM, RDM, RM, and RPE-MM (para 180-183. However, the RPE-MM did not comprise either a RAR antagonist or a canonical Wnt inhibitor to drive maturation of immature RPE. Bharti taught including a Wnt inhibitor following maturation to form functional RPE monolayers (see para 185).
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/ Primary Examiner, Art Unit 1632
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