DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 07/17/2025 is acknowledged. The traversal is on the ground that the examiner has not established that the shared technical feature is disclosed in the prior art. This is not found persuasive because Levijoki teaches an aqueous pharmaceutical composition comprising a selective D2 family dopamine agonist like ropinirole and in formulation in aqueous solution at about 5.7% (falling in within the claimed range) with excipients including EDTA which is a known chelator/scavenger of iron as established/evidence by Rowe wherein as the composition contains the same recited structural components claimed of ropinirole in water and the instant specification addresses that a solution with these components (as ropinirole does not contain iron) can have trace amounts of iron at 86ppb/10ml .and 330ppb/10ml the trace amount of iron the 1ml formulation of Levijoki per the specification would have to be about 8.6ppb-about 33pb in the 1ml formulation which is within the claimed values; and with a known chelator of iron of EDTA present in the formulation it would be even less as the amount of ETA is greater than the trace iron demonstrated by the instant specification where it would be chelated/scavenged in the solution (i.e. 1.1mf EDTA in 1ml is about 0.0038mmmol chelated/scavenging the smaller trace iron per the specification i.e. about 1.5-5.9x10-7mmol) wherein the technical feature does not contribute over the prior art and Applicant has not provided evidence that the prior art formulation with the iron chelator that would address trace iron as there is no added iron component does not fall within the claims. Additionally the instant specification utilizes a known chelator of iron to address the trace iron which is present in the prior art presented.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application
Applicant has elected Group I in response to restriction requirement and elected for the examination.
Due to restriction, based on election of Group I, claims 14-22 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-22 are pending.
Claims 1-13 are present for examination at this time.
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
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.
Claims 1-7, 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levijoki et al. (U.S. Pat. Pub. 2016/0206555) as evidenced by Rowe et al. (Edetic Acid).
Rejection:
Levijoki et al. teaches an aqueous pharmaceutical composition comprising a selective D2 family dopamine agonist like ropinirole; and teaches formulations with ropinirole in aqueous solution at about 5.7% with excipients including edetate disodium (also Known as EDTA/edetic acid, see formulation of Example 9-12,
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) which are sterilized (sterile water, abstract, [14-15, 24, 41-45], claims 5, 19-20, 23-24, see full document specifically areas cited); and edetate disodium is a known chelator/scavenger of iron as established/evidenced by Rowe (edetic acid, also known as EDTA, Col. 1 second to last paragraph). As the solution contains the recited structural components of ropinirole in water as claimed are met, the desired results and properties are met such as the stability to degradation/impurity B are met as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope. As the instant specification addresses that the trace amount of iron can be 86ppb/10ml of ropinirole HCI which is 8.6ppb per ml (e.g. instant experiment 1-3) and 330ppb/10ml of ropinirole HCI which is 33ppb per ml (e.g. instant experiment 4); the amount of trace iron in the 1ml formulation in examples 9-12 of Levijoki et al. would inherently be below the ranged claims as it would be about 8.6ppb to about 33ppb in the 1ml as demonstrated by the instant specification and within the claimed range. Additionally, as EDTA is present and a known iron scavenger/chelator, the amount of trace iron would be less as there is more EDTA than the trace iron present as demonstrated by the specification wherein it would be chelated/scavenged in the solution (i.e. 1.1mg EDTA in 1ml is about 0.0038mmol chelating/scavenging the smaller trace iron (i.e. about 1.5-5.9 x10°” mmol)). It is noted that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342,1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). An inherent feature need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. The fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.
All the critical elements are taught by the cited reference and thus the claims are anticipated.
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.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Levijoki et al. (U.S. Pat. Pub. 2016/0206555) as evidenced by Rowe et al. (Edetic Acid) as applied to claims 1-7, 11-13 above.
Rejection:
The teachings of Levijoki et al. as evidenced by Rowe et al. are addressed above.
Levijoki et al. as evidenced by Rowe et al. does not expressly exemplify the ranges recited but does teach that the ropinirole or its pharmaceutical salt can be from about 0.2-about 10% more typically from 0.3-8% [25] and about 90-99.8% of sterile water [25-26].
While Levijoki et al. as evidenced by Rowe et al. does not teach the exact claimed values for the sterile water but they are embraced (instant claim 8-9) or overlap the taught ranges (instant claim 10); wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize within the taught range to attain the desired therapeutic profile and arrive at the claimed values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitz et al. (U.S. Pat. Pub. 2014/0275202).
Rejection:
Schmitz et al. teaches an aqueous composition comprising ropinirole with excipients like buffers and antioxidants to reduce impurities and improve stability with a pH from about 3.0-about 6.5 (abstract, [51]). The composition contains excipients to achieve a desired pH and stability (has stability to pH (has buffers), also has stability to impurities e.g. low or no impurities like compound/impurity B (4-[2-(dipropylamino) ethyl]indoline-2,3-dione hydrochloride) ([53, 55], includes amounts like 0.04% 0.01%, 0.001%, zero and near zero). The aqueous solvent includes sterile water [51]. composition is for injection, the antioxidants include one or more of sequestering agents like the sodium salt of ethylenediaminetetraacetic acid (EDTA), and acids like citric acid, ascorbic acid, and sodium citrate [71]. The antioxidant can be from about 0.1, about 5% up for about 20% [71]. The ropinirole can be from 0.05mg/ml-133mg/ml (about 0.005-about 13.3%) [15] and exemplified at 1.5%wt/v (Example 2-3 [91-93]). Schmitz et al. exemplifies that formulation with antioxidants like citrate buffered formulations have little to no impurity of compound B at a month like the instant specification which addresses that the iron content corresponds with the degradation rate of ropinirole (amount of impurity B, Table F) wherein it is implicit if not prima facie obvious that the amount of trace iron would fall within the recited ranges as demonstrated/evidence by instant specification for the correspondence of trace iron to the impurity B with a reasonable expectation of success).
While prior art does not teach the exact claimed values for ropinirole and water for the instant dependent claims they are embraced (ropinirole about 0.005-about 13.3%, sterile water about ropinirole about 99.99%-about 86.7%) wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize within the taught ranges to attain the desired therapeutic profile and arrive at the claimed values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Conclusion
Claims 1-13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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