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 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.
Claim(s) 1-5, 7-9, 12-16, 18-19, 21 and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar et al. (Nucleic Acids Research, 2002, vol. 30, no. 23, e130, pp 1-8 – NPL reference 2 from applicant’s IDS filed 5/8/25).
Kumar discloses compositions comprising aqueous ammonium hydroxide and lithium chloride in various amounts (0.5M, 1.0M, or 1.5M). The compositions also contain ethylenediamine, spermine, polyvinylamine, or tris (2-aminoethyl) amine in various amounts (see table 1) and the ammonia hydroxide (aqueous ammonia) is 32% - see page 2, right column, 1st full paragraph. The composition is taught to be used to cleave a molecule off of a solid support, and therefore also discloses the molecules prepared (cleaved) by contacting the solid support bound molecule with the composition.
Claim(s) 1-5, 7-16, 18-21, and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipate by Nelson et al. (BioTechniques, vol 22 (4), pp 752-756, 1997 – NPL reference 13 from applicant’s IDs filed 5/8/25).
Nelson discloses the use of a cleavage and deprotection solution comprising 0.5M LiCl (lithium chloride) in concentrated ammonium hydroxide and added 0.23M triethylamine to affect the deprotection procedure (see page 753, right column, 1st full paragraph, figure 2; page 755 left column, 1st and 2nd full paragraphs; and conclusion on page 756). The composition is taught to be used to cleave a molecule off of a solid support, and therefore also discloses the molecules prepared (cleaved) by contacting the solid support bound molecule with the composition.
Claim(s) 1-9, 12-16, 18-19, and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar et al. (Reactive and Functional Polymers, vol. 41, 1999, pp 197-204).
Kumar discloses compositions used for cleaving oligonucleotides from solid supports comprising aqueous ammonia (ammonium hydroxide), methylamine, and 0.5M lithium chloride and 0.1M lithium hydroxide (see paragraph bridging columns 1-2 on page 198, paragraph (i) on page 200 in the left column). The composition is taught to be used to cleave a molecule off of a solid support, and therefore also discloses the molecules prepared (cleaved) by contacting the solid support bound molecule with the composition.
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.
Claims 1-16, 18-21, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kumar et al. (Nucleic Acids Research, 2002, vol. 30, no. 23, e130, pp 1-8 – NPL reference 2 from applicant’s IDS filed 5/8/25) – hereinafter “Kumar 1” and Kumar et al. (Reactive and Functional Polymers, vol. 41, 1999, pp 197-204) – hereinafter “Kumar 2”.
The claims of the present application are drawn to compostions comprising about 0.1-40% w/w of one or more of a lithium salt and at least about 50% saturated with ammonia. Dependent claims provide for various additional agents such as triethylamine and limits the lithium salt to various salts such as lithium hydroxide or lithium chloride.
Kumar 1 discloses compositions comprising aqueous ammonium hydroxide and lithium chloride in various amounts (0.5M, 1.0M, or 1.5M). The compositions also contain ethylenediamine, spermine, polyvinylamine, or tris (2-aminoethyl) amine in various amounts (see table 1) and the ammonia hydroxide (aqueous ammonia) is 32% - see page 2, right column, 1st full paragraph. The composition is taught to be used to cleave a molecule off of a solid support, and therefore also discloses the molecules prepared (cleaved) by contacting the solid support bound molecule with the composition. What is not taught is to use lithium hydroxide.
Kumar 2 teaches that lithium chloride and lithium hydroxide can be used in the compositions for cleaving their oligonucleotides from supports thus rendering obvious this missing feature from Kumar 1. Moreover, applicants have shown that lithium chloride is their preferable lithium cation source and lithium hydroxide did not provide any beneficial or unexpected properties (see table 2A herein). As such, the present claims are seen to be rima facia obvious in view of the art.
Conclusion
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/TRAVISS C MCINTOSH III/ Primary Examiner, Art Unit 1693
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