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 .
Status of the Claims
Claims 92-126 are pending (claim set as filed on 07/06/2026).
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 07/06/2026 is acknowledged. The non-elected claims were canceled therewith.
Therefore, claims 92-126 are presented for examination.
Priority
This application is a 371 of PCT/US2022/023797 which has provisional applications to:
(1) PRO 63/275,691 filed on 11/04/2021; and (2) PRO 63/171,837 filed on 04/07/2021.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 07/05/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Interpretation
Independent claim 92’s preamble recites “A method of treating a disease in a mammalian subject” and therefore the claim, as a whole, is directed to a treatment methodology (i.e., the statutory class of invention is directed to a process of use) (MPEP 2111.02: Effect of the preamble).
However, in the body of the claim, it recites the phrase “(mDA) neuronal precursor cells generated by culturing human pluripotent cells” which invokes the interpretation of a product-by-process claim. The MPEP 2113 states that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”.
Accordingly, the product-by-process limitations have been considered but they carry limited patentable weight because it merely describes how the mDA cells were obtained. However, the patentability analysis or emphasis is based upon the treatment process itself (e.g., the patient population, specific type of disorder or disease and accompany symptoms, the effect of the pharmaceutical active ingredients, the treatment outcome, routes of administration, etc.) because “a claim preamble has the import that the claim as a whole suggests for it” (MPEP 2111.02 and MPEP 2141.02).
Claim Objections
Claim 116 recites “The method of any one of claim 111,” and therefore is objected to because it implies that there is a plurality of claim 111.
Claim Rejections - 35 USC §112, Indefinite
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.
Claims 97, 102, and 121 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claims 97, 102, and 121, the phrase “such as” and “preferably” renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention (MPEP 2173.05(d): Exemplary Claim Language).
Claim Rejections - 35 USC §102, Anticipation
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.
Claims 92-126 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McMahon (WO 2018/035214 - cited by the ISA and in the IDS filed on 07/05/2024).
McMahon’s general disclosure relates to the field of molecular biology and medicine, more particularly, it concerns methods of generating dopaminergic neurons from pluripotent cells (see ¶ [0002]). McMahon discloses “the cell populations are contemplated to find use in cell replacement therapies for patients with diseases resulting in loss of function of a defined cell population” (see ¶ [0003]). McMahon teaches “cells are exposed to a BMP inhibitor (e.g., dorsomorphin or LDN-193189) and the cells are not exposed to a TGF-β inhibitor such as SB431542, to promote differentiation of cells into midbrain DA neurons or FOXA2+/LMX1A+ cells” (see ¶ [0006]).
Regarding claims 93-99, McMahon teaches “in the case of Parkinson’s disease, for example, it is the loss of midbrain dopaminergic (DA) neurons that results in the appearance of disease symptoms. Thus, there is need for methods of producing DA neuronal cells from pluripotent cells, since such cells could be used both therapeutically and in disease models, e.g., to identify new therapeutics for treatments for Parkinson’s disease” (see ¶ [0004], [00125]). McMahon teaches “midbrain DA neurons produced according to methods of the present invention may be administered to a subject to treat a CNS disease (e.g., administered to the brain or mid brain, such as the caudate nucleus, putamen, or substantia nigra to treat Parkinson’s Disease). Such diseases can include, but are not limited to, neurodegenerative diseases, such as parkinsonism” (see ¶ [00118]-[00119]).
Regarding claims 100-101, McMahon teaches “support matrices in which the stem cells or neurons can be incorporated or embedded include matrices that are recipient-compatible and that degrade into products that are not harmful to the recipient. The support matrices can be natural (e.g., hyaluronic acid, collagen, etc.) and/or synthetic biodegradable matrices. Synthetic biodegradable matrices that may be used include synthetic polymers such as polyanhydrides, polyorthoesters, and poly lactic acid. In some embodiments, dopaminergic neurons (e.g., dopaminergic neurons that are not fully differentiated) are embedded in hyaluronic acid matrix” (see ¶ [00122]-[00124]).
Regarding claims 102-105 pertaining to the amount of cells, McMahon teaches cells were thawed and transplanted bilaterally to the caudate and putamen (1.5 x106 cells/ injection) of MPTP-treated and immunosuppressed monkeys (see ¶ [00152]-[00153]).
Regarding claims 106-109 and 122-124, claim interpretation: a wherein or whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited (MPEP 2111.04). Since the prior art teaches the conditions and active method steps, then the intended results of the claims should also be natural features of the art.
Regarding claims 114-115, McMahon teaches “for purposes of manufacture, distribution, and use, the neural cells such as midbrain DA neurons as described herein may be supplied in the form of a cell culture or suspension in an isotonic excipient or culture medium, optionally frozen to facilitate transportation or storage” (see ¶ [00128]).
Regarding claims 110-113 and 116-120 pertaining to the expression markers, McMahon teaches “about at least 40%, at least 60%, at least 80%, or at least 85% of cells differentiate and express both FOXA2 and LMX1 (such as LMX1A). In some embodiments, about at least 30%, at least 40%, at least 50%, at least 60%, or at least 70% of cells differentiate and express both FOXA2 and tyrosine hydroxy lase (TH). The differentiated cells expressing FOXA2 and LMX1 (such as LMX1A), or FOXA2 and TH, may further express at least one marker selected from the group consisting of orthodenticle homeobox 2 (OTX2), nuclear receptor related 1 protein (NURRl), Neuron-specific class III beta-tubulin (Tuj1), TTF3, paired-like homeodomain 3 (PITX3), achaete-scute complex (ASCL), early B-cell factor 1 (EBF-1), early B-cell factor 3 (EBF-3), transthyretin (TTR), synapsin, dopamine transporter (DAT), and G-protein coupled, inwardly rectifying potassium channel (Kir3.2/GIRK2), CD142, DCSMl, CD63 and CD99” (see ¶ [0009]).
Regarding claims 125-126 pertaining to the injection, McMahon teaches “methods of administering stem cells or differentiated neuronal cells to a subject, particularly a human subject, include injection or transplantation of the cells into target sites (e.g., striatum and/or substantia nigra) in the subject. The stem cells and/or DA neurons can be inserted into a delivery device which facilitates introduction, by injection or transplantation, of the cells into the subject. Such delivery devices include tubes, e.g., catheters, for injecting cells and fluids into the body of a recipient subject” (see ¶ [00120]-[00121]).
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 92-95 and 100-101 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 76-77 (claim set as filed on 01/27/2026) of co-pending Application no. 16/782,772. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claimed invention and co-pending ‘772 are directed to a method of treating Parkinson’s disease in a mammalian subject comprising administering dopaminergic neuronal cells (see co-pending’s claims 76-77).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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