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 .
Election/Restrictions
Applicant's election with traverse of Group III, claims 32-36, in the reply filed on 01/27/2026 is acknowledged. The traversal is on the ground(s) that “the additional search burden on the Office to search the non-elected inventions is minimal”. For the sake of compact prosecution and based on the amendments Applicant has presented on 01/27/2026, the restriction requirement for Group I, claims 1 and 28-30, is being withdrawn and only claims 28-30 are being rejoined at this time. Regarding the additional non-elected groups, Applicant’s argument is not found persuasive because Groups II, IV, V, and VI are drawn to methods of making and using the elected invention and would amount to a search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 31 and 37-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/27/2026.
Status of the Claims
Claims 1, 29-32, 34-40, and 42-44 are currently pending.
Claims 1, 30, 32, 40, and 42 are amended.
Claims 31, 37-40, and 42-44 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 2-28, 33, and 41 are cancelled.
Claims 1, 29-30, 32, and 34-36 have been considered on the merits.
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.
Claims 1, 29-30, and 32-34 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mahajan et al (US2020/0361877A1).
Regarding claim 1, Mahajan teaches a pluripotent stem cell ([0420]) comprising inactivated/decreased GBX2, CDX1, CDX2, and CDX4 genes ([0416]).
Regarding claim 29, Mahajan teaches wherein GBX2, CDX1, CDX2, CDX4, GBX1, HOXa1, HOXA2, and HOXb1 genes are inactivated/decreased ([0416]).
Regarding claim 30, Mahajan teaches that the genes are inactivated with a genome editing system ([0033]) which can be a gene knockout ([0143]/[0400]) or the introduction of a stop codon ([0082]).
Regarding claim 32, Mahajan teaches a neural stem cell or neural progenitor cells ([0420]) comprising inactivated/decreased GBX2, CDX1, CDX2, and CDX4 genes ([0416]).
Regarding claim 34, Mahajan teaches wherein GBX2, CDX1, CDX2, CDX4, GBX1, HOXa1, HOXA2, and HOXb1 genes are inactivated/decreased ([0416]).
Therefore, Mahajan anticipates the claims.
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.
Claims 32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Mahajan et al (US2020/0361877A1), in view of Tian et al (Scientific Reports, 2015, “Selective Generation of Dopaminergic Precursors from Mouse Fibroblasts by Direct Lineage Conversion”).
Regarding claim 35, The limitations of the independent claim 32 are taught above.
Mahajan teaches a neural stem cell or neural progenitor cells ([0420]) comprising inactivated/decreased GBX2, CDX1, CDX2, and CDX4 genes ([0416])
Mahajan is silent as to the dopaminergic neuron progenitor cell or cell having lineage thereto expressing “FOXA2, LMX1A, OTX2, EN1, and/or TH; and/or expresses FOXA2, LMX1A, OTX2, EN1, SPRY1, WNT1, CNPY1, PAX8, ETV5, PAX5, SP5 and/or is TLE4 positive” as required by claim 35.
However, Tian teaches about the selective generation of dopaminergic precursors from mouse fibroblasts by direct lineage conversion.
Regarding claim 35, Tian teaches that ectopic expression of FOXA2 positively regulates LMX1A, OTX2 and other key transcription factors responsible for DA neuron development (pg. 10, last para). This meets the limitation of claim 35 wherein a cell having lineage toward a dopaminergic neuron progenitor cell expresses “FOXA2, LMX1A, OTX2, EN1, and/or TH” of claim 35. Additionally, Tian teaches “it is likely that Foxa2 may be a more potent determinant of midbrain DA progenitors than Lmx1a and SHH” (pg. 10, para 1).
One of ordinary skill in the art at the effective filling date of the instant invention would find it obvious to combine the neural stem cell or neural progenitor cell having inactivated GBX2, CDX1, CDX2, and CDX4 genes of Mahajan with the dopaminergic lineage cell markers described by Tian. One of ordinary skill would be motivated to make this combination because Tian teaches it is likely that Foxa2 may be a more potent determinant of midbrain DA progenitors than Lmx1a and SHH (pg. 10, para 1). One of ordinary skill in the art would have a reasonable expectation of success when combining Mahajan with Tian because Mahajan teaches that the cells are converted or differentiated from one cell type to another based on the expression of transcription factors ([0417]) and Tian provides all the necessary information to generate dopaminergic precursor cells through the expression of FOXA1.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filling of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632