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 .
Claim Objections
Claims 17 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
(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) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Prakash et al. (US 9,382,540 B2).
Prakash et al. teach an antisense oligonucleotide consisting of 16 nucleotides, wherein the oligonucleotide is complementary to a corresponding portion of 13 consecutive nucleotides of positions 1732-1759 of instant SEQ ID NO: 1 (see SEQ ID NO: 3716 in columns 613-614 of Prakash et al. wherein nucleotides 1-13, 15, and 16 are complementary to the instantly recited region).
Prakash et al. teach methods of delivering the antisense oligonucleotide to reduce ANGPTL3 by 70% (column 614) (instant claim 1). The oligonucleotide would would necessarily reduce ANGPTL4 absent evidence to the contrary because Prakash et al. teach delivery of an oligonucleotide having a structure within the instantly recited genus. Since Prakash et al. teaches a method comprising each of the instant method steps, the method would necessarily achieve the recited outcome, absent evidence to the contrary. As stated in the MPEP (see MPEP 2112), something that is old does not become patentable upon the discovery of a new property.
Prakash et al. teach: Each distinct region may comprise uniform sugar moieties, variant, or alternating sugar moieties. The wing-gap-wing motif is frequently described as “X—Y—Z”, where “X” represents the length of the 5′-wing, “Y” represents the length of the gap, and “Z” represents the length of the 3′-wing. “X” and “Z” may comprise uniform, variant, or alternating sugar moieties. In certain embodiments, “X” and “Y” may include one or more 2′-deoxynucleosides. “Y” may comprise 2′-deoxynucleosides. As used herein, a gapmer described as “X—Y—Z” has a configuration such that the gap is positioned immediately adjacent to each of the 5′-wing and the 3′ wing. Thus, no intervening nucleotides exist between the 5′-wing and gap, or the gap and the 3′-wing. Any of the antisense compounds described herein can have a gapmer motif. In certain embodiments, “X” and “Z” are the same; in other embodiments they are different. In certain embodiments, “Y” is between 8 and 15 nucleosides. X, Y, or Z can be any of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30 or more nucleosides (columns 129-130) (instant claims 1 and 2).
Prakash et al. teach incorporation of a 2’-4’ bridged nucleotide (column 25) (instant claims 3 and 4); LNA (column 129) (instant claims 5 and 6); and a phosphorothioate backbone (column 6) (instant claims 7 and 8).
Prakash et al. teach that the subject has obesity (column 1250 (instant claim 9).
Prakash et al. teach: The hypercholesterolemia can be familial homozygous hypercholesterolemia (HoFH), familial heterozygous hypercholesterolemia (HeFH) (columns 125-126) (instant lcaim 10).
Prakash et al. teach: The diabetes can be type 2 diabetes or type 2 diabetes with dyslipidemia (column 126) (instant lcaim 11).
Therefore, the claims are anticipated by Prakash et al.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prakash et al. (US 9,382,540 B2), as applied to claims 1-11 above, further in view of Liu et al. (Oncotarget, Vol. 6, No. 25, 21004-21015, 2015).
Prakash et al. does not teach that the subject has cancer or a respiratory infection.
Liu et al. teach that ANGPTL2/LILRB2 signaling promotes the propagation of lung cancer cells (title). Liu et al. teach: Our results suggest that signaling involving ANGPTL2 and LILRB2 is important for lung cancer development and represents a novel target for treatment of this type of cancer (page 21004)(instant claims 14-16).
Liu et al. teaches: ANGPTL3 plays an important role in cancer growth and invasion [9]. ANGPTL4 is highly expressed in many tumors and promotes tumor growth and decreases apoptosis (page 21005).
Therefore, it would have been obvious to deliver the oligomer of Prakash et al. to a subject with a lung cancer with a reasonable expectation of inhibition of target gene expression.
It would have been obvious as a matter of design choice to delvier the oligomer of Prakash et al. to a subject having influenza because patients having conditions of the many genuses of Prakash et al. can have influenza at the same time. The claims are not directed to the treatment of any specific condition, but rather delivery to a subject having any of the instantly recited conditions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636
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