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 3-27-26.
Claims 31-55 are pending in the instant application.
Claims 45-55 are withdrawn as being drawn to a non-elected invention or species.
Claims 31-44 have been examined on their merits as set forth below.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3-27-26 has been entered.
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.
Claim 40 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 40 does not appear to be further limiting than claim 31, from which it depends.
Appropriate clarification is required.
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) 31, 32, 34, 35, 37-44 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lee et al (US 2014/0142160).
Lee et al (US 2014/0142160) teach pharmaceutical compositions comprising oligomeric compounds comprising between 12-50 nucleosides comprising a portion of at least 16 contiguous bases that are at least 80% complementary to SEQ ID No. 1358, which oligomers are optionally double stranded, gapmers, or single stranded, and which optionally comprise modified sugars, phosphorothioate internucleotide bonds, and/or modified bases, which oligomers optionally comprise conjugates (see esp. para 0048-0051, 0063, 0701-0737, 0750-0752, 0784, 1047-1049; see also the alignment between instantly claimed SEQ ID No. 1358 and SEQ ID No. 52243 of Lee as set forth below).
ALIGNMENT W/ SEQ ID NO 1358
RESULT 7
US-13-884-670-52243
(NOTE: this sequence has 6 duplicates in the database searched.
See complete list at the end of this report)
Sequence 52243, US/13884670
Publication No. US20140142160A1
GENERAL INFORMATION
APPLICANT: Lee, et al.
TITLE OF INVENTION: Polycomb-Associated Non-Coding RNAs
FILE REFERENCE: 00786-0775P04/MGH20865
CURRENT APPLICATION NUMBER: US/13/884,670
CURRENT FILING DATE: 2013-05-10
PRIOR APPLICATION NUMBER: 61/412,862
PRIOR FILING DATE: 2010-11-12
PRIOR APPLICATION NUMBER: 61/425,174
PRIOR FILING DATE: 2010-12-20
PRIOR APPLICATION NUMBER: 61/512,754
PRIOR FILING DATE: 2011-07-28
NUMBER OF SEQ ID NOS: 194345
SEQ ID NO 52243
LENGTH: 46
TYPE: DNA
ORGANISM: Mus musculus
Query Match 90.0%; Score 14.4; Length 46;
Best Local Similarity 68.8%;
Matches 11; Conservative 4; Mismatches 1; Indels 0; Gaps 0;
Qy 1 GGGTTATACTCAGGCT 16
||| :|:||:|||||:
Db 3 GGGCUAUACUCAGGCU 18
Claim(s) 31, 32, 37, 38, 42 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mounts, Wm. (US 2007/0009899).
Mounts, Wm. (US 2007/0009899) teaches compositions comprising single stranded oligomeric compounds comprising between 12-50 nucleosides comprising a portion of at least 16 contiguous bases that are at least 80% complementary to SEQ ID No. 1358, which oligomers optionally comprise modified internucleotide bonds and/or modified bases (See esp. para 0071; see also the sequence alignment between instantly claimed SEQ ID No. 1358 and SEQ ID No. 130812 of Mounts as set forth below).
RESULT 5
US-10-956-160-130812
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 130812, US/10956160
Publication No. US20070009899A1
GENERAL INFORMATION
APPLICANT: Wyeth
APPLICANT: Mounts, William M
TITLE OF INVENTION: NUCLEIC ACID ARRAYS FOR DETECTING GENE EXPRESSION IN ANIMAL
TITLE OF INVENTION: MODELS OF INFLAMMATORY DISEASES
FILE REFERENCE: 031896-044000 (AM101084)
CURRENT APPLICATION NUMBER: US/10/956,160
CURRENT FILING DATE: 2004-10-04
NUMBER OF SEQ ID NOS: 222274
SEQ ID NO 130812
LENGTH: 25
TYPE: DNA
ORGANISM: Canis familiaris
Query Match 90.0%; Score 14.4; Length 25;
Best Local Similarity 93.8%;
Matches 15; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 GGGTTATACTCAGGCT 16
||||||||||||| ||
Db 10 GGGTTATACTCAGACT 25
Claim(s) 31, 32, 34, 42 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Williams, A.J.(US 2005/0244851).
Williams, A.J. (US 2005/0244851) teaches compositions comprising single stranded oligomeric compounds comprising between 12-50 nucleosides comprising a portion of at least 16 contiguous bases that are at least 80% complementary to SEQ ID No. 1358, which oligomers optionally comprise modified sugars and/or modified bases (See esp. para 0071; see also the sequence alignment between instantly claimed SEQ ID No. 1358 and SEQ ID Nos. 1052034 and 2878147 of Williams as set forth below).
ALIGNMENTS W/ SEQ ID NO 1358
RESULT 4
US-11-036-498A-1052034
Sequence 1052034, US/11036498A
Publication No. US20050244851A1
GENERAL INFORMATION
APPLICANT: Alan J. Williams
TITLE OF INVENTION: Methods of Analysis of Alternative Splicing in Human
FILE REFERENCE: 3655.1
CURRENT APPLICATION NUMBER: US/11/036,498A
CURRENT FILING DATE: 2005-01-13
PRIOR APPLICATION NUMBER: 60/536,315
PRIOR FILING DATE: 2004-01-13
NUMBER OF SEQ ID NOS: 6102149
SEQ ID NO 1052034
LENGTH: 25
TYPE: DNA
ORGANISM: Homo sapien
Query Match 90.0%; Score 14.4; Length 25;
Best Local Similarity 93.8%;
Matches 15; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 GGGTTATACTCAGGCT 16
||||||||||||| ||
Db 10 GGGTTATACTCAGTCT 25
RESULT 6
US-11-036-498A-2878147
Sequence 2878147, US/11036498A
Publication No. US20050244851A1
GENERAL INFORMATION
APPLICANT: Alan J. Williams
TITLE OF INVENTION: Methods of Analysis of Alternative Splicing in Human
FILE REFERENCE: 3655.1
CURRENT APPLICATION NUMBER: US/11/036,498A
CURRENT FILING DATE: 2005-01-13
PRIOR APPLICATION NUMBER: 60/536,315
PRIOR FILING DATE: 2004-01-13
NUMBER OF SEQ ID NOS: 6102149
SEQ ID NO 2878147
LENGTH: 25
TYPE: DNA
ORGANISM: Homo sapien
Query Match 90.0%; Score 14.4; Length 25;
Best Local Similarity 93.8%;
Matches 15; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 GGGTTATACTCAGGCT 16
|||||||||||||| |
Db 3 GGGTTATACTCAGGAT 18
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.
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(s) 31-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 2014/0142160), Mounts, Wm. (US 2007/0009899) and Williams, A.J. (US 2005/0244851) in view of Macleod et al (US 2014/0107180).
The claims are drawn to pharmaceutical compositions comprising oligomeric compounds comprising between 12-50 nucleosides comprising a portion of at least 16 contiguous bases that are at least 80% complementary to SEQ ID No. 1358, which oligomers are optionally double stranded, gapmers, or single stranded, and which optionally comprise modified sugars, phosphorothioate internucleotide bonds, and/or modified bases, which oligomers optionally comprise conjugates, or optionally comprise gapmers comprising a central region of 6-10 nucleosides, and 2 flanking regions of 1-5 nucleosides, which flanking regions comprise cEt sugar moieties, and which central region comprises unmodified 2’-deoxyribosyl sugars and phosphorothioate internucleotide linkages for target gene inhibition.
Lee et al (US 2014/0142160), Mounts, Wm. (US 2007/0009899) and Williams, A.J. (US 2005/0244851) are relied upon as set forth in the 102 rejections above.
The primary references do not teach gapmers comprising cET sugar moieties.
Macleod et al (US 2014/0107180) teach the design and optimization of oligomers comprising gapmers comprising a central region of 6-10 nucleosides, and 2 flanking regions of 1-5 nucleosides, which flanking regions comprise cEt sugar moieties, and which central region comprises unmodified 2’-deoxyribosyl sugars and phosphorothioate internucleotide linkages for target gene inhibition (see esp. ¶¶ 0459, 0666, 0670, 0674, 0681, 0688, 0691).
It would have been obvious to provide for oligomers comprising the target gene sequences as instantly claimed because the prior art, as listed above, taught many oligomers sharing the same sequences as instantly claimed. One would have been motivated to incorporate modified residues, including modified sugars and internucleotide linkages as instantly claimed, because these modifications were well known in the art to enhance oligomer stability and target binding as taught previously by Lee. In addition, gapmers were well described, optimized and utilized in the prior art as previously disclosed by Macleod.
For these reasons, the instant invention would have been obvious to one of ordinary skill in the art at the time of filing.
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
5-28-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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