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 Status
This action is in response to the papers filed on 7/17/2024. Claims 1, 32, 46, 49, 52, 75 – 83, 85 – 87, 96, 98 and 114 are pending.
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.
Claims 1, 32, 46, 49, 52, 75, 78 – 80, 82, 85 – 87, 96, 98 and 114 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bowles et al. (U.S. Patent No. 10,954,513 B2; cited on IDS, hereinafter Bowles).
Regarding claims 1, 75 and 82, Bowles discloses CRISPR-Cas systems (Col. 1, starting at line 63 – Col. 2, line 5) comprising one or more vectors comprising: a promoter operably linked to one or more nucleotide sequences encoding a CRISPR-Cas system guide (gRNA), wherein the gRNA hybridizes with a target sequence of a DNA locus in a cell; and a regulatory element operably linked to a nucleotide sequence encoding a RNA-directed nuclease, wherein both components are located on the same or different vectors of the same system.
Regarding claims 1 and 32, Bowles discloses (Figure 7B and C) the gRNA-targeted expression of TNFR1 (transmembrane receptor) and IL1R1, respectively.
Regarding claims 46 and 49, Bowles discloses (Col. 21, line 20) targeting IL6R for RNA-guided transcriptional regulation as a method for the treatment of back pain. Bowles further discloses targeting gp130 (Col. 5, line 42), which is also known as IL6ST.
Regarding claim 52, Bowles discloses the use of TNFRSF1A or IL1R1 (Col. 36, line 12) as the target(s) for the Guide RNA screening in HEK293T cells.
Regarding claims 78 – 80, Bowles discloses that the pharmaceutical composition can comprise a CRISPR Cas9 protein from S. pyogenes (Col. 17, lines 1 – 5).
Regarding claim 85, Bowles discloses CRISPR based vectors containing sgRNAs (Col. 3, line 62).
Regarding claims 86 and 87, Bowles discloses that their invention can be administered to humans (Col. 6, line 36), domesticated animals, and livestock, which includes: dog, cats, and horses (Col. 6, lines 39 – 40).
Regarding claims 96 and 98, Bowles discloses (Col. 23, line 27) lipid nanoparticles (LNP) as pharmaceutically acceptable carriers, in which any of the nucleic acids, vectors, and gRNAs described can be administered in the form of a pharmaceutical composition.
Regarding claim 114, Bowles discloses administering a therapeutically effective amount of the pharmaceutical composition of claim 1 for the treatment of lower back pain (Claim 15).
Claim Rejections - 35 USC § 103
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.
Claims 76 – 77 and 83 are rejected under 35 U.S.C. 103 as being unpatentable over Bowles in view of Guilak et al. (U.S. Patent Application Publication No. 2018/0201951 A1; cited on IDS, hereinafter Guilak).
Regarding claims 76 – 77 and 83, Bowles teaches all of the elements of the current invention as stated above but does not explicitly state that the nucleotides encoding (Col. 16, line 20 – 25) the RNAs are engineered from mRNA or DNA. However, Guilak discloses in a patent application publication that focuses on compositions, systems and methods for cell therapy, (para. [0073]) that the delivery of nucleic acids encoding gene-modifying agents (e.g. site-specific nuclease), can include viral transduction or transfection of plasmid DNA or mRNA. The motivation would be to have multiple embodiments of the pharmaceutical composition in order to optimize for target cell type, expression duration, cargo size, immunogenicity, safety, etc.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the plasmid DNA or mRNA of Guilak for encoding guide RNAs and RNA-guided nucleases with the CRISPR-Cas system of Bowles, in order to generate multiple embodiments of the instant invention. Doing so would allow one skilled in the art to expand the range of applications and cell types to which the vector can be used.
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Bowles in view of Slaymaker et al. (Rationally engineered Cas9 nucleases with improved specificity. Science. 2016 Jan 1;351(6268):84-8. doi: 10.1126/science.aad5227; hereinafter Slaymaker)
Regarding claim 81, Bowles discloses a spCas9 protein (p. 2, Background) which is a S. pyogenes Cas9 protein but it is not the eSp Cas9 protein of claim 81. However, Slaymaker discloses the use of structure-guided protein engineering to generate (Abstract) an enhanced specificity SpCas9 (eSpCas9). Slaymaker provides the motivation for using eSpCas9 by demonstrating that eSpCas9 variants reduce off-target effects and maintain robust on-target cleavage.
It would have prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the enhanced specificity Cas9 (eSpCas9) protein of Slaymaker with the transmembrane-targeted CRISPR-Cas system of Bowles. Doing so would make the cellular delivery of the gene editing system more efficient, effective, and specific.
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.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 32, 46, 49, 75, 76, 77, 78, 79, 80, 81, 82, 83, 85, 86, 87, 96, 98 and 114 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 14, 28, 31, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 73, 74 and 75 of copending Application No. 19/505,153 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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