DETAILED ACTION
Claim(s) 1, 3-5, 7, 9, 11, 18, 20, 22, 30, 32, 34, 36-38, and 41-44 are pending in the application.
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 .
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 1 is understood to be directed to a population of modified hematopoietic stem and progenitor cells (HSPCs) where the cells carry one or more exogenous copies of a nucleic acid encoding progranulin. The recitation “exogenous copies of a nucleic acid encoding progranulin” is interpreted as a nucleic acid that encoding progranulin that has been introduced into the cells from an external source, e.g. gene editing, such as CRISPR/cas, TALENs or Zinc finger methodology or by viral vector transduction, e.g. using a lentiviral, adenoviral, adeno- associated or avian virus system. Therefore, claim 1 is being interpreted as being drawn to a population of modified hematopoietic stem and progenitor cells (HSPCs) where a nucleic acid that encodes progranulin has been introduced into the genome of the cells by gene editing or via a viral vector.
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 7, 9, 11, 22, 34, 36-38, and 43-44 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.
Claims 7, 9, 11, 22, 34, and 43-44 recite “such as”. This recitation is an exemplary language and it is unclear if what is recited after further limits the claim and if it is part of the claimed invention. So this creates ambiguity and renders the claims indefinite since these sequences are species specific and the cells are not. Therefore, the metes and bounds of the method recited in this claim cannot be determined. Claims 36-38 that depend from claim 34, are similarly rejected.
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.
(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.
Claim(s) 1, 3-5, 7, 9, 11, 18, 20, 22, 30, 32, 34, 36-38, and 41-44 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mason et al. (WO2020160468A1, filed on 01/31/2020, and published on 08/06/2020).
Regarding claim 1, Mason et al. teaches a population of modified hematopoietic stem and progenitor cells where the cells carry one or more exogenous copies of a nucleic acid encoding progranulin (page 42, lines 17-21). Mason et al. specifically teaches a population of cells that together contain one or more nucleic acids encoding GRN (page 42, lines 17-21). Mason et al. teaches in claims 46-47 that the cells are transfected or transduced ex vivo with a viral vector to express the protein. Mason et al. also teaches that the population of cells can be hematopoietic stem cells (page 1, lines 18-20).
Regarding claim 3: Following discussion of claim 1, Mason et al. further teaches in claims 46-47 that the cells are transfected or transduced ex vivo with a viral vector to express the protein.
Regarding claim 4: Following discussion of claim 1, Mason et al. further teaches that the nucleic acid is a a complementary DNA (cDNA) (page 86, lines 3-4).
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Regarding claim 5: Following discussion of claim 1, Mason et al. further teaches that the progranulin encoded by the exogenous copy of a nucleic acid comprises the amino acid sequence of SEQ ID NO: 106 (PAGE 91, lines 1-5), which is identical to instant SEQ ID NO: 2.
Regarding claim 7: Following discussion of claim 1, Mason et al. further teaches in claim 47 that the cells are transfected or transduced ex vivo with a viral vector such as a lentiviral vector.
Regarding claim 9: Following discussion of claim 7, Mason et al. further teaches that the lentiviral vector comprises the GRN cDNA under the control of the mammalian phosphoglycerate kinase (h PGK) promoter (page 175, lines 5-10).
Regarding claim 11: Following discussion of claim 1, Mason et al. further teaches the cells are mammalian cells, such as human cells (Example 10 and Figure 4B).
Regarding claim 18: Following discussion of claim 1, Mason et al. further teaches that the cells are produced by a method comprising contacting a sample of unmodified cells with a nucleic acid carrying an exogenous copy of a nucleic acid encoding progranulin; and allowing the nucleic acid encoding progranulin to integrate into the genome of the cells so as to produce a population of modified HSPCs (page 87, lines 5-23).
It is noted that the claim recites “wherein the HSPC cells are produced by a method comprising…”. This is a product-by-process limitation that claims cells made by the claimed method. The claim requires that the cells are produced by contacting the cells with a nucleic acid carrying an exogenous copy of a nucleic acid encoding progranulin and allowing it to integrate into the genome of the cells. Therefore, the cells of claim 18 must include an exogenous copy of a nucleic acid encoding progranulin. MPEP 2113 states “[E]ven 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 20, Mason et al. further teaches ex vivo method for producing a population of hematopoietic stem cells (HSPCs) modified to express progranulin, the method comprising contacting a sample of HSPCs with a vector carrying an exogenous copy of a nucleic acid encoding progranulin and culturing the cells obtained to produce a population of modified HSPCs cells expressing progranulin (claims 46-47, page 1, lines 18-20, page 42, lines 17-21, and page 78, lines 1-4).
Regarding claim 22: Following discussion of claim 20, Mason et al. further teaches in claim 47 that the cells are transfected or transduced ex vivo with a viral vector such as a lentiviral vector.
Regarding claim 30: Following discussion of claim 20, Mason et al. further teaches a population of progranulin expressing HSCs (page 42, lines 17-21 and page 1, lines 18-20).
It is noted that the claim recites “a population of progranulin expressing HPSCs produced by the method of claim 20”. This is a product-by-process limitation that claims cells made by the method of claim 20. The claim requires that the cells are produced by contacting the cells with a nucleic acid carrying an exogenous copy of a nucleic acid encoding progranulin and allowing it to integrate into the genome of the cells. Therefore, the cells of claim 18 must include an exogenous copy of a nucleic acid encoding progranulin. MPEP 2113 states “[E]ven 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claims 32 and 42: Following discussion of claim 1, Mason et al. further teaches a composition comprising the population of cells (claim 36 of Mason et al.).
Regarding claims 34, 41, 43, and 44, Following discussion of claim 1, Mason et al. further teaches a method for treating a patient having or at risk of developing a neurocognitive disorder, such as a frontotemporal lobar dementia comprising administering to the subject the population of modified HSPC cells (Abstract and claims 1-2, 36).
Regarding claims 36: Following discussion of claim 34, Mason et al. further teaches that the introduction of the HSPCs results in an increase in progranulin levels in brain tissue, in particular in microglia (page 3, lines 13-18).
Regarding claims 37: Following discussion of claim 34, Mason et al. further teaches that the HSPCs are autologous to the recipient subject (claim 45 of Mason et al.).
Regarding claims 38: Following discussion of claim 37, Mason et al. further teaches that the HSPCs are administered to the patient via intravenous (IV) injection (page 36, lines 9-12).
Conclusion
No claims are allowed.
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Hanan Isam Abuzeineh
/H.I.A./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633