DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 1-26-26.
Claims 142-190 are pending in the instant application.
Election/Restrictions
Claims 160-177 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1-26-26.
Applicant’s election without traverse of Group I, SEQ ID NO: 77 as the nucleic acid sequence of the guide sequence, SEQ ID NO: 759 as the nucleic acid sequence of the first flanking region and SEQ ID NO: 760 as the nucleic acid sequence of the second flanking region, SEQ ID NO: 761 as the nucleic acid sequence of the miR-30 sequence, SEQ ID NO: 767 as the nucleic acid sequence of the miR-218-1 sequence, SEQ ID NO: 685 as the nucleic acid sequence of the promoter, SEQ ID NO: 746 as the nucleic acid sequence of the 5' ITR sequence, SEQ ID NO: 792 as the nucleic acid sequence of the RBG polyadenylation signal, SEQ ID NO: 815 as the nucleic acid sequence of the stuffer sequence, SEQ ID NO: 789 as the nucleic acid sequence of the 3' ITR sequence, SEQ ID NO: 759 as the nucleic acid sequence of the first flanking region of the first stem-loop, SEQ ID NO: 765 as the nucleic acid sequence of the first flanking region of the second stem- loop sequence, SEQ ID NO: 760 as the nucleic acid sequence of the second flanking region of the first stem-loop sequence and SEQ ID NO: 766 as the nucleic acid sequence of the second flanking region of the second stem-loop sequence, claims 142-159, 178-190, in the reply filed on 1-26-26 is acknowledged.
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 144-159, 178-181 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 144 is not further limiting than claim 142, from which it depends.
Claims 142-159, 178-190 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the multitude of sequences, molecular components, vectors and various combinations is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The alternatives are not all members of the same recognized physical or chemical class or the same art-recognized class and the members are not considered to be functionally equivalent.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
Claims 144-153, 155-159, 178-184, 186-189 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The breadth of the claims:
The claims are drawn to compositions comprising compositions comprising a polynucleotide comprising a guide nucleic acid sequence having at least 85%, 90%, 92%, 95%, 97%, 99%, or 100% sequence identity to the nucleic acid sequence of any one of SEQ ID NOs: 1-100, which polynucleotide of claim 142 141, wherein the polynucleotide is an antisense oligonucleotide (ASO), wherein the ASO is a short interfering RNA (siRNA), a short hairpin RNA (shRNA), a microRNA (miRNA), or a short hairpin-adapted miRNA (shmiRNA), and an expression cassette comprising the polynucleotide of claim 142 141, wherein the expression cassette comprises (a) a stem-loop sequence comprising, from 5' to 3', (i) a 5' stem loop arm comprising the guide sequence having at least 85% sequence identity to any one of SEQ ID NOs: 1-100; (ii) a loop region, wherein the loop region comprises a microRNA loop sequence; (iii) a3' stem loop arm comprising a passenger sequence complementary or substantially complementary to the guide sequence, (b) a first flanking region located 5' to said guide sequence; and (c) a second flanking region located 3' to said passenger sequence.
Teachings in the specification
The specification teaches Table 2, pages 68-75, listing antisense oligonucleotide sequences targeting Grik2 mRNA; Table 3, pages 94-96, listing siSPOTR-predicted Grik2 mRNA antisense sequences; Table 4, pages 124-126, listing Grik2 variants; Table 5, pages 148-153, listing exemplary promoter sequences; Table 6, pages 155-158, listing exemplary regulatory sequences; Table 7, pages 161-162, listing ; Table 8, pages 191-192, listing micro RNA sequences; Table 9, page 197, listing exemplary expression cassettes.
The specification fails to provide the broad genus comprising any antisense sharing 90% homology to the target gene, and further whereby target gene inhibition is provided. The specification, prior art and claims do not adequately describe the genus of modulatory agents claimed, and/or fail to provide a representative number of species, and do not indicate what distinguishing attributes are concisely shared by the members of this genus, and further whereby inhibition has been provided.
For the reasons stated above, the instant rejection for lacking adequate written description is proper.
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.
Claim(s) 142, 143, 158 and 159 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Naito et al (US 2008/0113351).
Naito et al (US 2008/0113351) teach an expression vectors comprising antisense with at least 85% identity with SEQ ID No. 77 (See para 0127; SEQ ID No. 632409 and the alignment below with instantly claimed SEQ ID No. 77).
RESULT 15
US-11-598-052B-632409/c
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 632409, US/11598052B
Publication No. US20080113351A1
GENERAL INFORMATION
APPLICANT: RNAi Co., Ltd.
APPLICANT: NAITO, Yuki
APPLICANT: FUJINO, Masato
APPLICANT: OGUCHI, Shinobu
APPLICANT: NATORI, Yukikazu
TITLE OF INVENTION: POLYNUCLEOTIDES FOR CAUSING RNA INTERFERENCE AND METHOD FOR INHIBITING GENE EXPRESSION USING THE
TITLE OF INVENTION: SAME
FILE REFERENCE: 0230-0243PUS1
CURRENT APPLICATION NUMBER: US/11/598,052B
CURRENT FILING DATE: 2006-11-13
PRIOR APPLICATION NUMBER: PCT/IB2005/00164
PRIOR FILING DATE: 2005-05-11
PRIOR APPLICATION NUMBER: JP 2004-232811
PRIOR FILING DATE: 2004-05-11
NUMBER OF SEQ ID NOS: 817670
SEQ ID NO 632409
LENGTH: 19
TYPE: DNA
ORGANISM: Mus musculus
FEATURE:
OTHER INFORMATION: siRNA target sequence for Grik2 (NM_010349.1,2457-2475).
Query Match 85.7%; Score 18; Length 19;
Best Local Similarity 77.8%;
Matches 14; Conservative 4; Mismatches 0; Indels 0; Gaps 0;
Qy 4 UCGAUAUGGAGAACCCAU 21
:|||:|:||||||||||:
Db 19 TCGATATGGAGAACCCAT 2
Allowable Subject Matter
SEQ ID Nos. 77 and 811 appear free of the prior art searched and of record.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Jane Zara
3-12-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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