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 .
Priority
Applicant’s claim for the benefit of a prior-filed application 17/093,126 (now issued as patent US 12084679) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claims status
Claims 1-27 is/are under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: While step (a) using the term “pluripotent stem cells”, step (b) uses “pluripotent cells”. Since cells that are pluripotent are a type of stem cells, it is clear that step (a) and (b) refer to the same cells. However, for the sake of consistency, it is recommended that step (b) also recite “pluripotent stem cells”.
Similar amendment should be made in Claim 1-line 8.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 2-6, 15, 25-27 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 2 depends from claim 1 and recites “the cells”. Claim 1 recites two types of cells: pluripotent stem cels and population of differentiated cells. It is unclear which cell type is being referred to in claim 2.
Claim 3, 4, 15 is/are rejected due their dependence on claim 2 because they do not clarify the 112b issue noted with claim 2.
Claims 5 and 6 each depend from claim 1 and recites “the cells”. Claim 1 recites two types of cells: pluripotent stem cels and population of differentiated cells. It is unclear which cell type is being referred to in claims 5 and 6.
Claim 25-27 recites the limitation "the initial concentration" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
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Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10858635. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 11 of `635 is directed to an in vitro method for differentiating pluripotent stem cells into differentiated cells expressing FOXA2 and LMX1A wherein the pluripotent stem cells are contacted with inhibitor of TGFb/Activin-Nodal signaling, activator of SHH signaling and Wnt activator wherein the concentration of Wnt activator is increased about 4 days (recited in claim 8 of `635 that claim 11 depends from; =claimed about 2-6 days which are also recited in claim 1 of `635) to a concentration of about 3-10uM.
Thus claim 1 is obvious over and patentably indistinct from claim 11 of `635.
Claim 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 recite identical limitations to claims 2, 3, 4, 6, 7, 8, 12, 13, 14, 14, 16+17, 18, 28, 5, 19, 23, 24, 25, 27, 20, 21, 22, 26 of `635 respectively. Thus, claim 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 are obvious over and patentably indistinct from claim 2, 3, 4, 6, 7, 8, 12, 13, 14, 14, 16+17, 18, 28, 5, 19, 23, 24, 25, 27, 20, 21, 22, 26 of `635 respectively.
Claims 25-27 recite specific initial concentration of Wnt activator of about 0.001-2uM, specifically 0.1-1uM, more specifically 0.7uM.
Claims in `635 do not recite a specific initial concentration however do teach the increased concentration of about 3-10uM (claim 11), more specifically about 3uM (claim 12) or about 7.5uM (claim 13). Claims in `635 also recite the percent increase from the initial concentration of about 250-1800% (claim 1), specifically about 400-1450% (claim 9), more specifically about 700-1050% (claim 10). Taken together, the broadest claims in `635 (claim 1, 11) teach an initial concentration range of 0.15-2.85uM while narrower claims in `635; such as claims 10 and 13; teach an initial concentration range of 0.65-0.93uM. Since the claimed ranges overlap and the specifically recited initial concentration of claim 27 lies inside the ranges disclosed by claims in `635 “a prima facie case of obviousness exists” (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). (See MPEP 214.05)
Therefore, claims 1, 9-13 of `635 render claims 25-27 prima facie obvious.
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,084,679. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 10 of `679 is directed to an in vitro method for differentiating pluripotent stem cells into differentiated cells expressing FOXA2 and LMX1A wherein the pluripotent stem cells are contacted with inhibitor of TGFb/Activin-Nodal signaling, activator of SHH signaling and Wnt activator wherein the concentration of Wnt activator is increased about 4 days (recited in claim 7 of `679 that claim 10 depends from; =claimed about 2-6 days which are also recited in claim 1 of `679) to a concentration of about 3-10uM.
Thus claim 1 is obvious over and patentably indistinct from claim 10 of `679.
Claim 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 recite identical limitations to claims 2, 3, 4, 5, 6, 7, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 11, 23, 24, 25, 26, 27 of `679 respectively. Thus, claim 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 are obvious over and patentably indistinct from claim 2, 3, 4, 5, 6, 7, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 11, 23, 24, 25, 26, 27 of `679 respectively.
Claims 25-27 recite specific initial concentration of Wnt activator of about 0.001-2uM, specifically 0.1-1uM, more specifically 0.7uM.
Claims in `679 do not recite a specific initial concentration however do teach the increased concentration of about 3-10uM (claim 10), more specifically about 3uM (claim 11) or about 7.5uM (claim 12). Claims in `679 also recite the percent increase from the initial concentration of about 100-2000% (claim 1), specifically about 400-1450% (claim 8), more specifically about 700-1050% (claim 9). Taken together, the broadest claims in `679 (claim 1, 10) teach an initial concentration range of 0.14-9uM while narrower claims in `679; such as claims 9 and 12; teach an initial concentration range of 0.65-0.93uM. Since the claimed ranges overlap and the specifically recited initial concentration of claim 27 lies inside the ranges disclosed by claims in `679 “a prima facie case of obviousness exists” (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). (See MPEP 214.05)
Therefore, claims 1, 8-12 of `679 render claims 25-27 prima facie obvious.
Claims 1-17, 20-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-13, 15-18 of copending Application No. 17/681,113 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other
Claim 7 of `113 is directed to an in vitro method for differentiating stem cells into differentiated cells that express midbrain dopamine neuron markers wherein the stem cells are contacted with SMAD inhibitor, activator of SHH signaling and Wnt activator wherein the concentration of Wnt activator is increased about 4 days (recited in option (i); =claimed about 2-6 days) to a concentration of about 3-10uM, 3uM or 7.5uM (recited in options (iii-v).
Claim 18 of `113 identifies that stem cells in the disclosed method are pluripotent stem cells, as required by instant claims 1.
Claim 13 of `113 identifies that the differentiated cells in the disclosed method express FOXA2, LMX1A, as required by instant claims 1.
Claim 8(ii) of `113 identifies that the SMAD inhibitor in the disclosed method is TGFb/Activin-Nodal signaling inhibitor, as required by instant claims 1.
Taken together, claims 7, 8, 13 and 18 of `113 teach an in vitro method for differentiating pluripotent stem cells into differentiated cells that express FOXA2 and LMX1A wherein the pluripotent stem cells are contacted with TGFb/Activin-Nodal signaling inhibitor, activator of SHH signaling and Wnt activator wherein the concentration of Wnt activator is increased about 4 days (recited in option (i); =claimed about 2-6 days) to a concentration of about 3-10uM, 3uM or 7.5uM (recited in options (iii-v). Therefore, claims 7, 8, 13 and 18 of `113 render the instant claim 1 prima facie obvious.
Claim 8(ii) of `113 identifies that the disclosed method could comprise a combination of SMAD inhibitors such as TGFb/Activin-Nodal signaling inhibitor and BMP inhibitor, as required by instant claim 2.
Claims 4 and 5 of `113 teach SMAD inhibitor and SHH activation for about 5 or 7 days, as required by instant claims 3, 4.
Claim 6 of `113 teaches Wnt activation for about 10 or 12 days, as required by instant claims 5, 6.
Claim 7(i, iv, v) of `113 teaches increasing Wnt activation about 4 days from initial contact to about 3 or 7.5uM, as required by instant claims 7-9.
Claim 13 of `113 identifies that the differentiated cells in the disclosed method express TH, NURR1, EN1, as required by instant claims 10.
Claim 15 in `113 identify that the differentiated cells do not express PAX6, as required by instant claim 11.
Claims 16 and 17 of `113 identify further differentiation step with identical maturation conditions of instant claim 12.
Claim 18 of `113 identifies that stem cells in the disclosed method are pluripotent stem cells, as required by instant claims 1, 13.
Claim 9(i) of `113 identifies that TGFb/Activin-Nodal signaling inhibitor in the disclosed method is SB431542, which is a TGFb receptor inhibitor, as required by instant claims 14, 20.
Claim 9(v) of `113 identifies that BMP inhibitor in the disclosed method is LDN193189, as required by instant claims 15.
Claim 8(v), 9(vi), 11 of `113 identifies that SHH activator in the disclosed method is SHH protein such as recombinant or purified SHH or SHH C25II, as required by instant claims 17.
Claim 8(iv) of `113 identifies that Wnt activator in the disclosed method CHIR99021, Wnt3A or Wnt1, as required by instant claims 16, 21, 22.
Claim 8(v), 12 of `113 identifies that purmorphamine as a smoothened agonist, as required by instant claims 23.
Claims in `113 do not recite a specific initial concentration however do teach the increased concentration of about 3-10uM, more specifically about 3uM or about 7.5uM (claim 7). Claim 7 in `679 also recite the percent increase from the initial concentration of about 300-1000%. Taken together, claim 7 of `113 teach an initial concentration range of 0.27-2.5uM or 0.68-1.8uM, if 7.5uM is the specific final concentration. Since the claimed ranges overlap and the specifically recited initial concentration of claim 27 lies inside the ranges disclosed by claims in `113 “a prima facie case of obviousness exists” (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). (See MPEP 214.05)
Therefore, claims 1, 7 of `113 render claims 25-27 prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Aguilla et al (Cellular Programming and Reprogramming: Sculpting Cell Fate for the Production of Dopamine Neurons for Cell Therapy. Stem Cells International Volume 2012, Article ID 412040, 17 pages) and Cho et al (Highly efficient and large-scale generation of functional dopamine neurons from human embryonic stem cells. PNAS, Vol. 105, No. 9, 2008) are relevant prior art teaching dopamine neuron differentiation methods comprising FGF.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras Jr. can be reached at (571)272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATASHA DHAR/Examiner, Art Unit 1632
Prosecution Insights