Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-20 are pending and under consideration.
Claim Rejections - 35 USC § 112-2nd paragraph
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 1-13 and 16-20 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.
The phrase “the at least one activator of SHH signaling” lacks antecedent basis at line 7 of claim 1. The claim does recite “inducing activation of Sonic hedgehog (SHH) signaling” but is not limited to doing so via use of an activator of SHH. It is not clear if claim 1 is intended to be limited to activation of SHH signaling through administration of a direct activator of SHH signaling or if it is intended to encompass other means of induction such as transgene expression, repressing repressors of SHH etc. Claims 2-13 and 16-20 are included based on their dependency from claim 1. Claims 14 and 15 are not included as they clarify that SHH signaling is induced through exposure to an activator.
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.
A) Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8,10 and 7 of U.S. Patent No. 11,970,712. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical but an examined application is not patentably distinct from the reference claims because the examined claim is either anticipate by, or would have been obvious over, the reference claims. See, e.e., 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). Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 is generic to all that is recited in claim 1 of US 11,970,712. That is, claim 1 of ‘712 falls entirely within the scope of claims 1,10,12 and 14 of the instant application. Dependent pending claims 2-7 recite the same limitation as patented claims 2-8. Pending claims 8-9 parallel limitations of patented claim 10.
B) Claims 1 and 7-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1,5-17 of U.S. Patent No. 10,711,243. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical but an examined application is not patentably distinct from the reference claims because the examined claim is either anticipate by, or would have been obvious over, the reference claims. See, e.e., 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). Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 is generic to all that is recited in claim 1 of US 10,711,243. That is, claim 1 of ‘243 falls entirely within the scope of claim 1 of the instant application. Pending claim 1 requires at least 10% of the population express FOXA2 and LMX1A while the patented claim requires greater than 40%. Dependent pending claim 7 recites the same limitation as patented claim 14. Pending dependent claims 8-17 limitations parallel patented claims 5-9.
C) Claims 1 and 7-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 6-7,9 of U.S. Patent No. 10,280,398. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical but an examined application is not patentably distinct from the reference claims because the examined claim is either anticipate by, or would have been obvious over, the reference claims. See, e.e., 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). Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 of the instant application requires the GSK signal inhibition take place 3 days from the initial TGFb/Activin/BMP inhibition while the patented claim 1 requires the GSK signal inhibition take place on the 3rd through 11th day following initial exposure to TGFb/Activin/BMP inhibition. Thus, the instant claim 1 is generic to all that is recited in claims 1 and of US 10,711,243. That is, claim 1 of ‘243 falls entirely within the scope of claim 1 of the instant application. Pending dependent claims 8-17 limitations parallel patented claims 6,7 and 9.
D) Claims 2-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,280,398 in view of Perrier (2004, PNAS, 101:12543-12548; IDS).
E) Claims 2-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,711,243 in view of Perrier (2004, PNAS, 101:12543-12548; IDS).
The ‘243 and ‘398 patents render obvious claim 1 as set forth above. Neither patent claims further culture of precursor cells to obtain DA neurons.
Perrier teaches culture of neural precursors obtained through formation of rosettes on a stromal cell layer under conditions that mature the cells into dopaminergic neurons (page 12544. Col. 1 para 1), meeting the limitations of claim 2. With regard to claim 3, Perrier teaches final maturation in N2 medium supplemented with BDNF,GDNF, dibutyryl cAMP, TGF-b3 and ascorbic acid (see page 12544, col. 1, para 1, last 4 lines). The resulting cells coexpress tyrosine hydroxylase and Tuj1, meeting the limitations of claim 4 (see page 12546, col. 1, para 1). Claim 5 requires the dopamine neurons be A9 subtype. The specification at page 101 lists Nurr1 as a marker of A9 subtype neurons and Perrier teaches Nurr1 expression in the dopamine neurons. Claim 6 limits the method to further comprising a step of selecting cells. Selection is a mental step that is given little patentable weight given that it cannot be determined if a mental step has occurred. However, Perrier does teach detection of ALDH1 expression and this is considered “selection” of cells expressing ALDH1.
It would have obvious at the time of filing to carry out the maturation of neural precursor cells into DA neurons as taught by Perrier using the patented methods. One would have been motivated to do so as the patented method of obtaining the precursors was a shorter and simpler method that the rosette culture of Perrier.
With regard to claim 6, that the dopamine neurons be obtained no later than about 25 days from initial exposure to SMAD inhibition, Fasano did not further mature the posteriorized FP DA neuron precursor cells (En1 and Lmx1b expressing cells) and Perrier did not obtain the dopaminergic precursor cells using the SMAD inhibition protocol of Fasano. However, Perrier obtained the DA neurons from the precursors (En1 and Lmx1b expressing cells) within 8 days (see Figure 5) and Fasano, relied upon for obtaining the DA neuron precursors (posterior floorplate cells), taught an 11 day protocol for obtaining the precursors which would be a total of no more than about 25 days. Fasano teaches the use of the SMAD inhibition protocol as being faster than the rosette protocol of Perrier.
Conclusion
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/ Primary Examiner, Art Unit 1632