DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I and SEQ ID NO:76 in the reply filed on 6/16/2025 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.
Claim 52 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 52 recites “wherein the conjugate group. . .”. there is no antecedent basis for this language in claim 50 from which claim 52 depends. It appears applicant may have intended for claim 52 to depend from claim 51.
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.
Claim(s) 37-42, 45, and 46, 51-55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Butler et al (US20160145629).
Butler et al have disclosed siRNA compounds targeting TMPRSS including siRNAs comprising SEQ ID NO:1003. SEQ ID NOS:1003 is 21 nucleotides in length and the siRNA is comprised of sequences that are identical to or complementary to the instant SEQ ID NO:1.
SEQ ID NO:1003 on bottom, instant SEQ ID NO:76 on top
Qy 3 ATCAGGGACGAGAC 16
Db 20 ATCAGGGACGAGAC 7
Butler et al have also disclosed that siRNA compounds of their invention can be made from two single stranded oligonucleotides to form a duplex and further that the compounds of their invention can be single stranded antisense compounds (paragraphs 7, 120, 125, and 196-198, for example). It has been disclosed modifications to internucleoside linkages, sugar moieties and bases (see paragraphs 8, 12, 37, 241, 245, 247, SEQ ID NO:1003, and compound AD63608.1 (Table 13), for example). It has been disclosed conjugates such as GalNAc (see paragraphs 38, 64, 97, 396, and 399-408, for example). It has also been disclosed pharmaceutical compounds utilizing PBS (see paragraphs 123 and 445, for example). While the entire reference is relevant and relied on, applicant is directed to paragraphs 7, 8, 12, 37, 38, 41-46, 55, 62, 66, 120, 123, 125, 133, 196-198, 232, 238, 245-247, 249, 373, 388, 396, 399-408, and 445, for example.
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.
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) 37-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al (US20160145629).
Butler et al have also disclosed that siRNA compounds of their invention can be made from two single stranded oligonucleotides to form a duplex and further that the compounds of their invention can be single stranded antisense compounds (paragraphs 7, 120, 125, and 196-198, for example). It has been disclosed modifications to internucleoside linkages, sugar moieties and bases (see paragraphs 8, 12, 37, 241, 245, 247, SEQ ID NO:1003, and compound AD63608.1 (Table 13), for example). It has been disclosed conjugates such as GalNAc (see paragraphs 38, 64, 97, 396, and 399-408, for example). It has also been disclosed pharmaceutical compounds utilizing PBS (see paragraphs 123 and 445, for example).
Butler et al do not specifically disclose a compound of based on SEQ ID NO:1003 that contains bicyclic sugar moieties or gapmer motifs.
Butler et al have taught to make siRNA and antisense compounds targeting TMPRSS expression to treat diseases such as beta-thalassemia and hemochromatosis. SEQ ID NO:1003 as AD63608.1 was shown in Table 13 to be an effective inhibitor of TMPRSS expression providing a motivation to make oligomeric compounds comprising or based on SEQ ID NO:1003. Butler et al have taught the benefits of modifications recited in the claims and have taught that one in the art can utilize any of the well known and established modifications known in the art and also to utilize ligands for the increased effectiveness of oligomer administration to cells and tissues (paragraphs 238, 247 and 399-408, for example). It would have been obvious to utilize any of the modifications recited in the claims including the gapmer motifs, bicyclic moieties, and 5-methylcytosine, recited in claims 43, 47, 48, 49 and 50 since these modifications were well known and routinely utilized in the art at the time the application was effectively filed. While the entire reference is relevant and relied on, applicant is directed to paragraphs 7, 8, 12, 37, 38, 41-46, 55, 62, 66, 120, 123, 125, 133, 196-198, 232, 238, 245-247, 249, 373, 388, 396, 399-408, and 445, for example.
The invention as a whole would therefore have been prima facie obvious to one in the art at the time the application was effectively filed.
The following prior art is made of record and not relied upon but is considered pertinent to applicant's disclosure. US20140194489 discloses SEQ ID NOS:329 and 330 which are comprised in siRNA compounds and correspond with the instant SEQ ID NO:76. The closest prior art is applied above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN MCGARRY whose telephone number is (571)272-0761. The examiner can normally be reached M-Th/F 9:00-7:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram Shukla can be reached at 571 272 1600. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN MCGARRY/Primary Examiner, Art Unit 1635
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