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 2-16-26.
Claims 1-24 are pending in the instant application.
Election/Restrictions
Claims 19-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.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 2-16-26.
Applicant’s election without traverse of Group I, claims 1-18, double stranded nucleic acid molecules, and the species of a protein encoding gene as a target gene, in the reply filed on 2-16-26 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.
Claim14 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.
In claim 14, lines 1-2, “partial sequence of a target gene” is vague. The metes and bounds of a partial sequence cannot be determined.
Appropriate clarification is required.
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 1, 17, 25-27, 30, 39-45, and 85 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 double stranded nucleic acid molecules comprising a sense strand 19-36 nucleobases long and an antisense strand 21-38 nucleobases long and includes an undefined length of a sequence complementary to the sense strand, which strands include chemically modified nucleotides at various positions as set forth below in the 102 rejections, and which double stranded molecules optionally further comprise additional polynucleotide sequences up to 30 nucleotides on the 3’ of the sense strand and on the 5’ end of the antisense strand, which sequences are not complementary to each other.
Teachings in the specification:
The specification teaches various double stranded nucleic acid molecules with and without various modifications, listed in Tables 1-8 and comprising 22-26 nucleotides with essentially full complementarity between the sense and antisense strands.
The specification, prior art and claims do not adequately describe the genus of molecules claimed, comprising double stranded nucleic acid molecules comprising a sense strand 19-36 nucleobases long and an antisense strand 21-38 nucleobases long and includes an undetermined amount of sequence complementary between the strands, which strands comprise various positional modifications (as described in the 102 rejections below), and which strands optionally further comprise polynucleotide sequences comprising up to 30 additional nucleotides on the 3’ terminus of the sense strand and on the 5’ terminus of antisense strand, that are not complementary to each other.
The examples taught in the specification, and the compositions taught in the examples in the specification, are not representative of the genus of double stranded nucleic acids claimed. The specification fails to provide a representative number of species, and does not indicate what distinguishing attributes are concisely shared by the members of this genus comprising long extensions lacking complementarity.
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) 1, 3, 5-7, 9-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Milstein et al (CA 3124090).
Milstein et al (CA 3124090) teach double stranded nucleic acid molecules comprising a sense strand 19-36 nucleobases long and an antisense strand 21-38 nucleobases long and includes a sequence complementary to the sense strand, which sense strand includes a chemically modified nucleotide at one position selected from the 4th, 5th, 7th and 14th from the 5’ end, and a chemical modification at the 1st position from the 5’ end, which modification optionally includes 2’-O-methyl, and which sense strand includes a chemically unmodified nucleotide at least one position selected from the 2nd, 3rd, 6th, 8th-13th, and 15th to 36th from the 5’ end, and which antisense includes a chemically modified nucleotide at a position complementary to a nucleotide at least one position selected from the 2nd, 3rd, 6th, and 10th-13th from the 5’ end of the sense strand, and a chemically unmodified at a position selected from the 1st, 4th, 5th, 7th, 9th, and 14th-36th from the 5’ end, which antisense and sense strand optionally further comprise a blunt end from the 3’ end, or which strands optionally comprise an overhang from 1-5 or 1-30 nucleobases from both or either termini, which overhangs optionally comprise a chemically unmodified nucleotide, and which overhangs are not complementary to each other, which double stranded nucleic acid molecule modulates expression of a protein encoding gene, and which double stranded nucleic acid molecules optionally comprising a hairpin (see esp. Duplexes AD-392699 and AD-392700 in Table 2A, page 189; pages 6-7, 6-10, 12, 14-16, 23, 39, 40, 68, 60, 64-66, 68).
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Maclachlan et al (WO 2013/052677).
Maclachlan et al (WO 2013/052677) teach double stranded nucleic acid molecules comprising a sense strand 19-36 nucleobases long and an antisense strand 21-38 nucleobases long and includes a sequence complementary to the sense strand, which sense strand includes a chemically modified nucleotide at one position selected from the 4th, 5th, 7th and 14th from the 5’ end, and a chemical modification at the 1st position from the 5’ end, which modification optionally includes 2’-O-methyl, and which sense strand includes a chemically unmodified nucleotide at least one position selected from the 2nd, 3rd, 6th, 8th-13th, and 15th to 36th from the 5’ end, and which antisense includes a chemically modified nucleotide at a position complementary to a nucleotide at least one position selected from the 2nd, 3rd, 6th, and 10th-13th from the 5’ end of the sense strand, and a chemically unmodified nucleotide at a position selected from the 1st, 4th, 5th, 7th, 9th, and 14th-36th from the 5’ end, which antisense strand includes a chemically unmodified nucleotide at the 7th position from the 5’ end, a chemically modified nucleotide at the 8th position from the 5’ end and a chemically modified nucleotide at the 2nd, 3rd, 6th or 10th-13th from the 5’ end of the sense strand, which antisense and sense strands optionally further comprise a blunt end from the 3’ ends, or which strands optionally comprise an overhang from 1-5 or 1-30 nucleobases from both or either termini, which overhangs optionally comprise a chemically unmodified nucleotide, and which overhangs are not complementary to each other, and which double stranded nucleic acid molecule optionally comprises a hairpin structure, which double stranded nucleic acid molecule modulates expression of a protein encoding gene (see esp. siRNA No. 4 and 5, Table A on page 92, pages 46-47).
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.
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Jane Zara
5-7-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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