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
Claims 14-15 and 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/22/26. Applicants argued that groups I and II are not patentably distinct and should not have been restricted as they are drawn to closely related methods of making the same class of compounds. The examiner agrees and has withdrawn the restriction requirement between groups I and II and claims 1-13 and 16-18 will be examined herein.
Applicants have also elected the species of using hydrogen malate in the claimed methods. The examiner has withdrawn the species requirement and will examine methods of using both hydrogen malate or hydrogen tartrate nicotinamide-β-D-ribofuranoside or the 2,3,5-tri-acyl derivatives thereof as starting compounds.
As such, claims 1-13 and 16-18 will be examined herein in their entirety, and claims 14-15 and 19-22 are withdrawn as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112 – 2nd paragraph
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.
Claims 5-7 and 12 are 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 5 recites the limitation "the nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside hydrogen malate or the nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside hydrogen tartrate" in 3rd-5th lines. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not provide for any nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside starting compounds.
Claim 6 recites the limitation "the nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside hydrogen malate or the nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside hydrogen tartrate" in 3rd-5th lines. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not provide for any nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside starting compounds.
Claim 12 provides that in step X, subjecting a salt of nicotinamide-β-D-ribofuranoside and a counter ion, wherein the counter ion is selected from Cl, Br, I, CF3SO3, n-C4F9SO3, FSO3, and ClO4 to salt metathesis comprising counter ion-exchange using hydrogen malate or hydrogen tartrate as counter-ion. As such, it is unclear what the counter ion is intended to be.
All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
Claim Rejections - 35 USC § 112 – 4th paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 provides that the hydrogen malate or hydrogen tartrate is either D-, L- or DL-form. However, it is noted these are the only forms available for these compounds and thus stating they are one of these forms would not limit the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1-3, 8-11, 13, and 16-18 are allowed. The closest prior art is seen to be WO17/218580 who teaches methods of using salt exchange reaction (salt metathesis) to convert one X- anion of nicotinamide riboside to another X-, for example converting one where it is not a chloride salt to the corresponding chloride salt. The anions which are taught to be converted to the chloride anions are fumarate, maleate, N-acetyl-D-tyrosinate, camsylate, and oxalate (see [0041]). Also taught to be used as X- in the starting compound is optionally tartrate (see claim 11). However, there is no trail blazed to using either malate or tartrate anions as starting compounds in converting to different salts of nicotinamide riboside as claimed herein. Further, applications have shown that their processes of using a malate salt as a starting material, when compared to using a differing anion such as triflate produced a much purer resulting salt. For example, example 8 shows a 90.7% pure salt when malate salts are the precursor to make a tosylate salt; example 11 shows a 82.2% pure salt when tartrate salts are the precursor to make a tosylate salt; and example 12a/b show 38% and 63% purity when triflate salt was used as the precursor to make a tosylate salt. Likewise, example 6a/b show bromide salts were produced from malate salts at 85.3% and 83% purity; example 9a/b show bromide salts were produced from tartrate salts at 77.2% and 79.4%% purity; wherein examples 14a/b show bromide salts were produced from tosylate salts at purities of 65.3.% and 55.8%. As such, one would not have expected the use of the hydrogen malate or hydrogen tartrate salts as starting compound sin salt metathesis to improve the purity of the final products and improve the yield from the reactions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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