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 1-20 are pending
Claims 1-20 have been examined on their merits.
Claim Objections
Claim 1 is objected to for the following informalities: claim 1 recites “CTE”. Abbreviations should be spelled out in their first instance. Amending the claim to recite “constitutive transport element (CTE)” would be ameliorative. Appropriate clarification is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 11 is 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 11 recites the limitation “the third target gene.” There is insufficient antecedent basis for this limitation in the claim because neither claim 11, nor the claim from which is depends (claim 1) establishes a basis for a third target gene. It is noted that claim 2 does establish a third target gene. However, claim 11 is amended to depend on claim 1 specifically. For compact prosecution, the limitation in claim 11 has been interpreted as referring to “a” third target gene. Changing dependency to claim 1 or establishing proper basis in the claim would be ameliorative.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites “wherein the CTE is a polynucleotide having the nucleotide sequence of SEQ ID NO: 2”. However, according to the specification, SEQ ID NO: 2 is a CAG promoter (paragraphs [0030, 0112]), while SEQ ID NO: 1 is a CTE (paragraphs [0023, 0112]), that therefore, these are different nucleotide sequences.
Furthermore, SEQ ID NOs 1 and 2 do not overlap in sequences and there is no indication in the specification that SEQ ID NO: 2 contains a CTE sequence. Therefore, the disclosure lacks written description for a CTE comprising SEQ ID NO: 2 as claimed.
It is noted however that SEQ ID NO: 2 appears to be unique (see ABSS search report on 07/30/2026). Therefore, clarifying the structural relationship between the recombinant vector and SEQ ID NO: 2 could result in the identification of allowable subject matter.
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 1-2, 4-6, 8, 12-15, 17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Naldini et al. (US20060200869A1, on IDS 09/20/2024).
In regards to claims 1 and 12-14, Naldini discloses a bidirectional recombinant lentiviral vector (thus, a gene delivery system which comprises a recombinant lentiviral virus) comprising a CTE, a minimal and an efficient promoter (i.e., first and second promoters), driving least two coding sequences (first and second target genes) in opposite (reverse) orientation (claims 1, 7-9; paragraph [0024]; Fig. 2).
In regards to claim 2, Naldini discloses that the efficient promoter can consist of a second minimal promoter sequence (and thus, a third promoter as claimed) (Claim 2; the vector can comprise “at least” two promoters (paragraph [0005]).
In regards to claim 4, Naldini discloses that the CTE can be in forward or reverse directions (Fig. 2).
In regards to claim 5, Naldini discloses that the promoters can be selected from at least Simian Virus 40 (paragraph [0024; Fig, 2).
In regards to claims 6 and 8, Naldini discloses that the invention can be used the delivery and expression of multiple genes in target cells, for gene therapy, and for the manufacturing of medicaments (paragraph [0001]). Naldini also disclose that it is known in the art that transgenes for expression in cells can comprise growth-promoting or drug-resistance genes together with the therapeutic gene (paragraph [0002]). Additionally, in specific embodiments, , Nalidni discloses that the genes may be at least reporter (e.g., luciferase, GFP; Fig. 2).
In regards to claims 15, 17, and 19-20, in regards to a “transformant”, the instant specification defines this term to mean “a cell produced by inserting a foreign gene into a host cell, and refers to a cell transfected with the recombinant vector or transduced with the recombinant virus. The transformant is also called a recombinant host cell, a recombinant cell, or a recombinant microorganism” (paragraph [0079]).
Turning to the art, Naldini discloses a hematopoietic cord blood CD34+ progenitor cell or peripheral blood lymphocyte (a type of immune cell) in which the recombinant vector has been transduced (paragraph [0026]; Fig. 2) (thus, a transformant as claimed). As Naldini discloses that the lymphocytes are activated with anti-CD3 and anti-CD28 antibodies (paragraph [0026]), a person of ordinary skill in the art would have recognized that they are T cells specifically.
Therefore, Naldini anticipates the invention as claimed.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Naldini et al. (US20060200869A1, on IDS 09/20/2024).
Naldini anticipates claims 1 and 6 as dicussed above.
In regards to claim 7, as above, Naldini teaches that the invention can be used the delivery and expression of multiple genes in target cells, for gene therapy, and for the manufacturing of medicaments (paragraph [0001]). Naldini teaches that it is known in the art that transgenes for expression in cells can comprise growth-promoting or drug-resistance genes together with the therapeutic gene (paragraph [0002]). Furthermore, Naldini teaches that it is known in the art that reconstitution of the dopamine biosynthetic pathway in striatal neurons of Parkinson's disease patients requires co-expression of genes such as tyrosine hydroxylase with GTp-cyclohydrolase I and/or DOPA decarboxylase (paragraph [0002]). Therefore, it would have been predicably obvious to adapt the gene of interest to a neurogenic disease based the teachings of Naldini.
Therefore, the teachings of Naldini render obvious the invention as claimed.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Naldini et al. (US20060200869A1, on IDS 09/20/2024) in view of Browning et al. (Journal of Virology, 2001).
Naldini anticipates claims 1 and 6 as dicussed above.
In regards to claim 9, as above, Naldini teaches that the invention can be used the delivery and expression of multiple genes in target cells, for gene therapy, and for the manufacturing of medicaments (paragraph [0001]). Naldini teaches that it is known in the art that transgenes for expression in cells can comprise growth-promoting or drug-resistance genes together with the therapeutic gene (paragraph [0002]). A person of ordinary skill in the art would have been motivated to include a selection marker gene in order to obtain a pure population of transduced cells. Furthermore, it would have been predictably obvious to use hygromycin B phosphotransferase because as taught by Browning, the hygromycin B phosphotransferase is known to promote drug resistance in cells transduced by lentiviral vectors (Fig. 1, p5131; Results, p5133).
Therefore, the combined teachings of Naldini and Browning renders the invention unpatentable as claimed.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Naldini et al. (US20060200869A1, on IDS 09/20/2024) in view of Kalomoiris et al. (Human Gene Therapy Methods, 2012).
Naldini anticipates claims 1 and 6 as dicussed above.
In regards to claim 10, as above, Naldini teaches that the invention can be used the delivery and expression of multiple genes in target cells, for gene therapy, and for the manufacturing of medicaments (paragraph [0001]). Naldini teaches that it is known in the art that transgenes for expression in cells can comprise growth-promoting or drug-resistance genes together with the therapeutic gene (paragraph [0002]). A person of ordinary skill in the art would have been motivated to include a cell marker gene such as CD25 because Kalomoiris teaches that exogenous transduction of CD25 by vectors into cells which do not normally express genes improves their efficacy and is useful for therapies such as HIV gene therapies (Title, Abstract, p366). Furthermore, because Naldini teaches that the vector can be used for gene therapy and Kamomoris teaches that CD25 can be transduced by vectors, it could have been doen with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Naldini and Kalomoiris renders the invention unpatentable as claimed.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Naldini et al. (US20060200869A1, on IDS 09/20/2024) in view of Gautam et al. (J Gene Med, 2016).
Naldini anticipates claim 1 as dicussed above.
In regards to claim 11, it is noted that claim 11 is not drawn to a specific sequence. While it is unclear if in embodiments, the specific genes of the vector as taught by Naldini comprise Kozak sequences, it is noted that it is well-known in the art that most eukaryotic genes comprise Kozak sequences. However, in the event that Naldini does not teach that the genes comprise Kozak sequences, it would have been predicably obvious to include a Kozak sequence in the genes because Gautam teaches that it is well know that Kozak sequences improve gene expression using viral constructs (Discussion, p319, right column) and demonstrates that vector genes can be engineered with Kozak sequences (Lentiviral vector construction, p313-314).
Therefore, the combined teachings of Naldini and Gautam renders the invention unpatentable as claimed.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Naldini et al. (US20060200869A1, on IDS 09/20/2024) in view of McGinley et al. (Stem Cell Research and Therapy, 2011)
Naldini anticipates claims 1 and 15 as dicussed above.
In regards to claims 16 and 18, Naldini broadly teaches that the invention is for introduction of genes into target cells (a transformant), including umbilical cord blood cells (paragraphs [0009, 0017-0021, 0026]; Fig. 4), but does not explicitly teach that the transformant is a mesenchymal stem cell (MSC) specifically.
However, the use of vectors for the transduction of MSCs is long known in the art. A person of ordinary skill in the art would have been motivated to transduce a MSC (and thus establish an MSC transformant) in order to promote survival and increased resistance to apoptosis in conditions of hypoxia and ischemia which are useful for MSC-based therapies as taught by McGinley (Title, Abstract, p1). Furthermore, because Naldini broadly teaches that cells can be transduced and because McGinley demonstrates transducing MSCs derived from bone marrow (Title, Abstract, p1), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Naldini and McGinley renders the invention unpatentable as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kohn et al. (WO2017003792A1).
No claims are allowed.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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