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 .
DETAILED ACTION
Claims 10 and 19 are pending in the application. Claim 10 is rejected. Claim 19 is withdrawn from further consideration.
Response to Amendment / Argument
Rejections made in the previous Office Action have been overcome by Applicant's amendments to the claims.
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent PGPub No. 2019/0336508 A1 by Kamatani.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Kamatani generally teaches the following combinations (abstract):
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Kamatani teaches tablets for oral administration including the following example on page 7:
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Kamatani teaches tablets (a solid dosage form) including magnesium stearate, croscarmellose sodium (sodium carboxymethyl cellulose) and inosine.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The example above contains inosine whereas the instant claims embrace the presence of a pharmaceutically acceptable salt of succinyladenosine. Additional limitations of instant claim 10 are addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Kamatani teaches on page 3 that succinyladenosine or its pharmaceutically acceptable salts can be used in place of inosine:
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At least in the interest of determining which particular source of hypoxanthine would provide optimum results, a person having ordinary skill in art would have been motivated to test the replacement of inosine with the additional examples and their pharmaceutically acceptable salts in analogous compositions. Replacing inosine with a pharmaceutically acceptable salt of succinyladenosine would result in a composition containing the instantly required components. Magnesium stearate can be considered doubly included by the additional requirement of a “lubricating agent”. Regardless, the prior art teaches additional inert diluents including starch, microcrystalline cellulose and croscarmellose sodium (which is further embraced as sodium carboxymethyl cellulose in instant claim 10 where magnesium stearate could be considered solely as a lubricating agent). The limitation of “a synthetic excipient” is considered a product-by-process limitation that does not distinguish from the prior art.
The instant claim 10 recites that the composition comprises a therapeutically effective amount “of about 1.0 to about 30 mg/kg body weight” but where the instant claims place no limitation on an object of administration, a dosing regimen or actual level of effectiveness that must be observed. The noted limitation appears to be an intended use that does not materially limit the claim other than requiring that at least some theoretical object of administration must exist. Kamatani teaches the following range on page 3:
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The free base molecular weight of succinyladenosine is 383.31 g/mol and the molecular weight of inosine 268.23 g/mol and where the corresponding pharmaceutically acceptable salts would result in a higher weight ratio. Since the direct conversion of the formulation example above to contain a salt of succinyladenosine would correspond to at least 0.7 grams of the salt (corresponding to minimal body weights of ~20 kg to ~700 kg), at least one potential target of administration would exist for simple salts.
The limitation “for promoting angiogenesis” in claim 10 is considered an intended use that does not structurally limit the claims. Similarly, the limitation of “pharmaceutical” is considered an intended use that does not structurally limit the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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