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 .
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.
Claim Status
Claims 31-54 are currently pending and examined on the merits.
Claim Interpretation
With respect to claim 54, applicant's invention is interpreted as comprising product-by-process limitations. Under MPEP § 2113, product-by-process claims are not limited to the recited method steps, but are limited only by the resultant structure. Therefore, method steps are only considered in a patentability analysis to the extent that the method steps result in structural changes to the product. The limitation “produced by the method of claim 32” does not appear to confer any structural changes to claimed cell population and is therefore not considered in the patentability analysis.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
In view of the MPEP § 2106, claim 54 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Subject Matter Eligibility Guidance
A three part inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101 for process claims that involve laws of nature. See Subject Matter Eligibility Guidance. This inquiry comprises answering: 1) Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? 2A) Does the claim recite or involve one or more judicial exceptions? Judicial exceptions include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products. 2B) Does the claim as a whole recite something significantly more than the judicial exception(s)?
Claim Interpretation
With respect to claim 54 applicant’s invention is interpreted as comprising a substantially homogeneous population of midbrain dopaminergic progenitor cells (mDAPs).
Analysis in View of Claim Interpretation and Subject Matter Eligibility Guidance
1) Statutory Subject Matter
Claim 54 is directed to a population of cells, which is a composition of matter. Therefore, claim 54 is directed to statutory subject matter.
2A) Judicial Exception
1) Does the claim recite a judicial exception?
Claim 54 recites a judicial exception because the claim is directed to a population of cells, which is a product of nature.
2) Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 54 does not recite additional elements that integrate the judicial exception into a practical application because the claims are directed to a population of cells per se.
2B) Significantly More
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not incorporate any additional elements.
Summary
On balance the relevant factors weigh against eligibility and claims do not qualify as eligible subject matter under 35 U.S.C. § 101.
Claim Objections
Claim 40 is objected to because of the following informalities. Appropriate correction is required.
Claim 40 appears to be missing a comma between “GF109203X” and “and any combination thereof”.
Claim Rejections - 35 USC § 112
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 35-38 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 35 contains the limitations “even if the mDAPs have been expanded and passaged” and “maintains or even improves”. It is unclear if these limitations are required limitations of the claim as they appear to be conditional limitations. Further it is unclear what feature or method step “maintains or even improves” the expansion efficiency and expression of mDAP-specific markers.
Claim 37 contains the limitation “vitronectin (VTN), collagen, proteoglycan, fibronectin, entactin, elastin, laminin, a functional fragment of any proceeding protein, hyaluronic acid, gelatin, and any combination thereof, and preferably VTN”. It is unclear if this claim is indicating that a combination of coating matrix preferably includes VTN or if VTN is a preferred embodiment out of all recited coating matrix options.
Claim 38 contains the limitation “Jagged-2, a variant thereof, and any combination thereof”. It is unclear if this limitation is indicating that the variant is a Jagged-2 variant, or that the variant may be a variant of any of the preceding Notch agonists.
Claim Rejections - 35 USC § 102
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.
Claim(s) 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nolbrant et al., (2017) Generation of high-purity human ventral midbrain dopaminergic progenitors for in vitro maturation and intracerebral transplantation. Nature Protocols, 12: 1962-1979 (hereinafter Nolbrant).
Regarding claim 54, Nolbrant discloses methods of generating midbrain dopaminergic progenitor cells from induced pluripotent stem cells (Abstract). Nolbrant explains that the disclosed methods produce large quantities of xeno-free, high-purity dopaminergic progenitor cells (Introduction). Therefore, every limitation of claim 54 is present in Nolbrant and the subject matter is anticipated.
Allowable Subject Matter
Claims 31-34, 39, 41-53 allowed.
The following is a statement of reasons for the indication of allowable subject matter. The closest prior art fails to disclose or suggest a method of expanding mDAPs by culturing mDAPs on a culture substrate comprising a combination of a cell-adhesive component and a Notch agonist. The closest prior art is as follows.
Fehlings et al., US Publication No. 2024/0342218
Fehlings discloses methods of producing neural progenitor cells (Abstract). Fehlings discloses generating neural progenitors by culturing human progenitor cells to form neural rosettes ([0115]-[0125]). The neural rosettes are then isolated and cultured on substrate coated with a cell-adhesive component in the presence of the Notch agonist Delta-like 4 (DLL4) ([0126]). Preferably, the substrate is coated with poly-L-lysine, laminin, poly-L-lysine/laminin, fibronectin, vitronectin, collagen, Matrigel™, or Geltrex™ ([0052]). Fehlings explains that DLL4 is critical for maintenance of rosette structures and expression of neural progenitor markers ([0127]).
Fehlings does not disclose that the coating is a combination of a cell-adhesive component and a Notch agonist. Fehlings also does not disclose that the methods may be utilized to produce or expand dopaminergic progenitor cells.
Zhang et al., US Publication No. 2014/0248696
Zhang discloses methods of expanding neural progenitors , such as mDAPs (Abstract, [0009], [0020]). Zhang discloses culturing the neural progenitors in a media comprising a Notch signaling agonist ([0007], [0026], [0043], [0052]). In some embodiments, the neural progenitors may be maintained on polyornithine or laminin coated substrates ([0062]-[0063]).
Zhang does not disclose that the coating is a combination of a cell-adhesive component and a Notch agonist.
Vodyanyk et al., US Publication No. 2020/0263139
Vodyanyk discloses methods of culturing hematopoietic progenitor cells on coated surfaces comprising a matrix and a Notch ligand (claim 41). In some embodiments, the culture plate may be coated with a combination of the Notch agonist DLL4 and Retronectin, a fibronectin fragment ([0014], [0189], [0229]-[0230], [0232], [0246]-[0247], [0253], [0258]-[0259], Table 2).
Vodyanyk does not disclose that the substrate may be used to expand mDAPs.
Conclusion
Claims 31-34, 39, 41-53 are allowed. Claim 40 is objected to. Claims 35-38, 54 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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