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 12-21-23.
Claims 1-28 are pending in the instant application.
Claim Objections
Claims 1, 6, 18, 19, 23-25, 27, 28 are objected to because of the following informalities:
In claim 1, line (b), -- a – should precede “ 5’ ”; in line (c), -- a – should precede “ 3’ ”; in lines (ii)(b) and (ii)(c), “DNA nucleotide” should be replaced with – DNA nucleotides --.
In claim 6, line 2, -- the – should precede “ 5’ “.
In claim 7, lines 3 and 5, -- the – should be inserted before “ 5’ “ and “ 3’ “ respectively.
In claim 18, lines 4 and 6, -- the – should be inserted before “ 5’ “ and “ 3’ “ respectively.
In claim 19, lines 4 and 6, -- the – should be inserted before “ 5’ “ and “ 3’ “ respectively.
In claims 23-25, 27 and 28, line 1, “function” should be replaced with – functional --.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
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.
Claims 1-3, 5-28 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 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.
The claims are drawn to pharmaceutical compositions for reducing the level of a transcription product in a cell comprising a double stranded nucleic acid complex comprising a first nucleic acid strand annealed to a second nucleic acid strand, wherein (i) the first nucleic acid strand hybridizes to the transcription product, wherein the first nucleic acid strand is a nucleic acid strand which comprises (a) at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H when the first nucleic acid strand is hybridized to the transcription product, (b) a 5' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 5' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, (c) 3' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 3' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, and (d) the total number of the DNA nucleotides, modified DNA nucleotides and nucleotide analogs is 13 to 25, and wherein
(ii) the second nucleic acid strand is a nucleic acid strand which comprises (a) one or more DNA nucleotides and/or modified DNA nucleotides, and (b) one or more modified DNA nucleotides, nucleotide analogs and/or modified nucleotide analogs located on 5' terminal side of the plural DNA nucleotides and/or modified DNA nucleotides, and/or (c) one or more modified DNA nucleotide, nucleotide analogs and./or modified nucleotide analogs located on the 3' terminal side of the plural DNA nucleotide and/or modified DNA nucleotides, and (d) the second nucleic acid strand further comprises a functional moiety having a function selected from a labeling function, a purification function, and a targeted delivery function, which second nucleic acid strand comprises (a) plural DNA nucleotides, (b) a 5' wing region which consists of one or more modified nucleotides located on 5' terminal side of the plural DNA nucleotides, and/or (c) a 3' wing region which consists of one or more modified nucleotides located on 3' terminal side of the plural DNA nucleotides.
The specification, prior art and claims do not adequately describe the genus comprising the composition comprising these duplexes comprising a second strand of an undefined length. The specification and claims do not indicate what distinguishing attributes are concisely shared by this genus of oligomeric compounds.
The specification teaches various single and double stranded complexes and some triplex complexes. The lengths of the first and second strands vary from 12-mers to 20-mers, with one or two examples using a 31-mer complementary RNA based strand annealed to a 13-mer LNA/DNA gapmer, and teaches examples of a cPNA 8-mer and a cPNA 10-mer.
The specification does not appear to provide any examples of oligomeric compounds comprising first and second strands (or third strands) of any lengths other than those recited above. The specification therefore fails to provide a reasonable number of species of this very broad genus of duplex complexes claimed. The description provided by the instant disclosure is therefore insufficient.
One of skill in the art would reasonably conclude that the disclosure fails to provide an adequate description of the genus claimed.
Thus, Applicant was not possession of the claimed genus.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,028,387. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions for reducing the level of a transcription product in a cell comprising a double stranded nucleic acid complex comprising a first nucleic acid strand annealed to a second nucleic acid strand, wherein (i) the first nucleic acid strand hybridizes to the transcription product, wherein the first nucleic acid strand is a nucleic acid strand which comprises (a) at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H when the first nucleic acid strand is hybridized to the transcription product, (b) a 5' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 5' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, (c) 3' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 3' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, and (d) the total number of the DNA nucleotides, modified DNA nucleotides and nucleotide analogs is 13 to 25, and wherein (ii) the second nucleic acid strand is a nucleic acid strand which comprises (a) one or more DNA nucleotides and/or modified DNA nucleotides, and (b) one or more modified DNA nucleotides, nucleotide analogs and/or modified nucleotide analogs located on 5' terminal side of the plural DNA nucleotides and/or modified DNA nucleotides, and/or (c) one or more modified DNA nucleotide, nucleotide analogs and./or modified nucleotide analogs located on the 3' terminal side of the plural DNA nucleotide and/or modified DNA nucleotides, and (d) the second nucleic acid strand further comprises a functional moiety having a function selected from a labeling function, a purification function, and a targeted delivery function, which second nucleic acid strand comprises (a) plural DNA nucleotides, (b) a 5' wing region which consists of one or more modified nucleotides located on 5' terminal side of the plural DNA nucleotides, and/or (c) a 3' wing region which consists of one or more modified nucleotides located on 3' terminal side of the plural DNA nucleotides.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,034,955. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions for reducing the level of a transcription product in a cell comprising a double stranded nucleic acid complex comprising a first nucleic acid strand annealed to a second nucleic acid strand, wherein (i) the first nucleic acid strand hybridizes to the transcription product, wherein the first nucleic acid strand is a nucleic acid strand which comprises (a) at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H when the first nucleic acid strand is hybridized to the transcription product, (b) a 5' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 5' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, (c) 3' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 3' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, and (d) the total number of the DNA nucleotides, modified DNA nucleotides and nucleotide analogs is 13 to 25, and wherein (ii) the second nucleic acid strand is a nucleic acid strand which comprises (a) one or more DNA nucleotides and/or modified DNA nucleotides, and (b) one or more modified DNA nucleotides, nucleotide analogs and/or modified nucleotide analogs located on 5' terminal side of the plural DNA nucleotides and/or modified DNA nucleotides, and/or (c) one or more modified DNA nucleotide, nucleotide analogs and./or modified nucleotide analogs located on the 3' terminal side of the plural DNA nucleotide and/or modified DNA nucleotides, and (d) the second nucleic acid strand further comprises a functional moiety having a function selected from a labeling function, a purification function, and a targeted delivery function, which second nucleic acid strand comprises (a) plural DNA nucleotides, (b) a 5' wing region which consists of one or more modified nucleotides located on 5' terminal side of the plural DNA nucleotides, and/or (c) a 3' wing region which consists of one or more modified nucleotides located on 3' terminal side of the plural DNA nucleotides.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 12,344,841. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions for reducing the level of a transcription product in a cell comprising a double stranded nucleic acid complex comprising a first nucleic acid strand annealed to a second nucleic acid strand, wherein (i) the first nucleic acid strand hybridizes to the transcription product, wherein the first nucleic acid strand is a nucleic acid strand which comprises (a) at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H when the first nucleic acid strand is hybridized to the transcription product, (b) a 5' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 5' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, (c) 3' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 3' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, and (d) the total number of the DNA nucleotides, modified DNA nucleotides and nucleotide analogs is 13 to 25, and wherein (ii) the second nucleic acid strand is a nucleic acid strand which comprises (a) one or more DNA nucleotides and/or modified DNA nucleotides, and (b) one or more modified DNA nucleotides, nucleotide analogs and/or modified nucleotide analogs located on 5' terminal side of the plural DNA nucleotides and/or modified DNA nucleotides, and/or (c) one or more modified DNA nucleotide, nucleotide analogs and./or modified nucleotide analogs located on the 3' terminal side of the plural DNA nucleotide and/or modified DNA nucleotides, and (d) the second nucleic acid strand further comprises a functional moiety having a function selected from a labeling function, a purification function, and a targeted delivery function, which second nucleic acid strand comprises (a) plural DNA nucleotides, (b) a 5' wing region which consists of one or more modified nucleotides located on 5' terminal side of the plural DNA nucleotides, and/or (c) a 3' wing region which consists of one or more modified nucleotides located on 3' terminal side of the plural DNA nucleotides.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,337,006. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions for reducing the level of a transcription product in a cell comprising a double stranded nucleic acid complex comprising a first nucleic acid strand annealed to a second nucleic acid strand, wherein (i) the first nucleic acid strand hybridizes to the transcription product, wherein the first nucleic acid strand is a nucleic acid strand which comprises (a) at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H when the first nucleic acid strand is hybridized to the transcription product, (b) a 5' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 5' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, (c) 3' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 3' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, and (d) the total number of the DNA nucleotides, modified DNA nucleotides and nucleotide analogs is 13 to 25, and wherein (ii) the second nucleic acid strand is a nucleic acid strand which comprises (a) one or more DNA nucleotides and/or modified DNA nucleotides, and (b) one or more modified DNA nucleotides, nucleotide analogs and/or modified nucleotide analogs located on 5' terminal side of the plural DNA nucleotides and/or modified DNA nucleotides, and/or (c) one or more modified DNA nucleotide, nucleotide analogs and./or modified nucleotide analogs located on the 3' terminal side of the plural DNA nucleotide and/or modified DNA nucleotides, and (d) the second nucleic acid strand further comprises a functional moiety having a function selected from a labeling function, a purification function, and a targeted delivery function, which second nucleic acid strand comprises (a) plural DNA nucleotides, (b) a 5' wing region which consists of one or more modified nucleotides located on 5' terminal side of the plural DNA nucleotides, and/or (c) a 3' wing region which consists of one or more modified nucleotides located on 3' terminal side of the plural DNA nucleotides.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,329,567. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions for reducing the level of a transcription product in a cell comprising a double stranded nucleic acid complex comprising a first nucleic acid strand annealed to a second nucleic acid strand, wherein (i) the first nucleic acid strand hybridizes to the transcription product, wherein the first nucleic acid strand is a nucleic acid strand which comprises (a) at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H when the first nucleic acid strand is hybridized to the transcription product, (b) a 5' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 5' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, (c) 3' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 3' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, and (d) the total number of the DNA nucleotides, modified DNA nucleotides and nucleotide analogs is 13 to 25, and wherein (ii) the second nucleic acid strand is a nucleic acid strand which comprises (a) one or more DNA nucleotides and/or modified DNA nucleotides, and (b) one or more modified DNA nucleotides, nucleotide analogs and/or modified nucleotide analogs located on 5' terminal side of the plural DNA nucleotides and/or modified DNA nucleotides, and/or (c) one or more modified DNA nucleotide, nucleotide analogs and./or modified nucleotide analogs located on the 3' terminal side of the plural DNA nucleotide and/or modified DNA nucleotides, and (d) the second nucleic acid strand further comprises a functional moiety having a function selected from a labeling function, a purification function, and a targeted delivery function, which second nucleic acid strand comprises (a) plural DNA nucleotides, (b) a 5' wing region which consists of one or more modified nucleotides located on 5' terminal side of the plural DNA nucleotides, and/or (c) a 3' wing region which consists of one or more modified nucleotides located on 3' terminal side of the plural DNA nucleotides.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,844,374. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions for reducing the level of a transcription product in a cell comprising a double stranded nucleic acid complex comprising a first nucleic acid strand annealed to a second nucleic acid strand, wherein (i) the first nucleic acid strand hybridizes to the transcription product, wherein the first nucleic acid strand is a nucleic acid strand which comprises (a) at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H when the first nucleic acid strand is hybridized to the transcription product, (b) a 5' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 5' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, (c) 3' wing region which comprises one or more modified DNA nucleotides and/or nucleotide analogs located on 3' terminal side of the at least 4 consecutive DNA nucleotides and/or modified DNA nucleotides that are recognized by RNase H, and (d) the total number of the DNA nucleotides, modified DNA nucleotides and nucleotide analogs is 13 to 25, and wherein (ii) the second nucleic acid strand is a nucleic acid strand which comprises (a) one or more DNA nucleotides and/or modified DNA nucleotides, and (b) one or more modified DNA nucleotides, nucleotide analogs and/or modified nucleotide analogs located on 5' terminal side of the plural DNA nucleotides and/or modified DNA nucleotides, and/or (c) one or more modified DNA nucleotide, nucleotide analogs and./or modified nucleotide analogs located on the 3' terminal side of the plural DNA nucleotide and/or modified DNA nucleotides, and (d) the second nucleic acid strand further comprises a functional moiety having a function selected from a labeling function, a purification function, and a targeted delivery function, which second nucleic acid strand comprises (a) plural DNA nucleotides, (b) a 5' wing region which consists of one or more modified nucleotides located on 5' terminal side of the plural DNA nucleotides, and/or (c) a 3' wing region which consists of one or more modified nucleotides located on 3' terminal side of the plural DNA nucleotides.
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
7-21-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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