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 .
Priority
The instant application was filed 11 April 2024 and claims priority to provisional application 63/458,727 filed 12 April 2023. The effective filing date of the instant application is 12 April 2023.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-16) in the reply filed on 10 August 2026 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 August 2026.
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.
Claim(s) 1-3, 5-9, 12-14, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Labhasetwar (US 20220193310 A1).
Regarding claim 1, Labhasetwar teaches (entire teaching) a drug eluting agent (para. 7) comprising nanoparticles with polycaprolactone (para. 46), poloxamers as a non-ionic surfactant (para. 62), acetyl tributyl citrate or acetyl trihexyl citrate (plasticizing agent) (para. 102), and everolimus (therapeutic agent) (para. 76).
Regarding claim 2, the composition comprises acetyl tributyl citrate or acetyl trihexyl citrate (para. 102).
Regarding claim 3, the composition comprises polycaprolactone (para. 46).
Regarding claim 5, the composition may comprise 99% or less biocompatible agents, such as polymers, materials, and excipients (para. 38), where it is interpreted that the amounts of polymers and excipients may be in equal amounts.
Regarding claim 6, the composition comprises poloxamers (para. 62).
Regarding claim 7, the composition comprises poloxamer 188 as a solubilizing agent (para. 104).
Regarding claim 8, the composition may comprise 99% or less biocompatible agents, such as polymers, materials, and excipients (para. 38), where it is interpreted that the amounts of poloxamers/polymers and excipients may be in equal amounts.
Regarding claim 9, the composition may comprise 99% or less biocompatible agents, such as polymers, materials, and excipients (para. 38).
Regarding claim 12, the composition comprises everolimus (para. 76).
Regarding claim 13, the composition may further comprise antioxidants (para. 75).
Regarding claim 14, the composition comprises therapeutic agents, such as everolimus (para. 76), in amorphous or crystalline forms (para. 93). The composition further comprises acetyl trihexyl citrate (para. 102), wherein the therapeutic agents are encapsulated (paras. 14-15), which is interpreted as the composition encapsulating the crystalline everolimus.
Regarding claim 16, the composition may further comprise antioxidants (para. 75).
Labhasetwar does not teach an exact combination of a therapeutic agent, plasticizing agent, and polycaprolactone or poloxamer in claim 1.
In regards to selecting the combination of a therapeutic agent and polycaprolactone or poloxamer in claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Labhasetwar teaches (entire teaching) a drug eluting agent (para. 7) comprising nanoparticles with polycaprolactone (para. 46), poloxamers as a non-ionic surfactant (para. 62), acetyl tributyl citrate or acetyl trihexyl citrate (plasticizing agent) (para. 102), and everolimus (therapeutic agent) (para. 76), whereas the claimed invention is directed towards an elutable coating composition comprising a plasticizing agent, polycaprolactone or poloxamer, and a therapeutic agent. Since Labhasetwar teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Claim(s) 1, 3, 4, 9, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 9005161 B2), as evidenced by Contardi (Low molecular weight ε-caprolactone-p coumaric acid copolymers as potential biomaterials for skin regeneration applications, PLOS One, 2019).
Regarding claim 1, Wang teaches (entire teaching) a drug releasing coating (title) comprising polycaprolactone (col. 6, ln. 66-col. 7, ln. 4), a plasticizing agent (col. 4, lns. 58-61), and a therapeutic agent (abs).
Regarding claim 3, the composition comprises polycaprolactone (col. 6, ln. 66-col. 7, ln. 4).
Regarding claim 4, Wang teaches use of low molecular weight polymers/oligomers (col. 38, lns. 7-18), where it is interpreted that polycaprolactone would have a molecular weight as low as 3,000 g/mol (evidenced by Contardi, pg. 2).
Regarding claim 9, Wang teaches an amount of therapeutic agent of about 0.01-75% (col. 15, lns. 50-56), where it is interpreted that the remaining amount may be excipients, falling within the range of 10-40%. Furthermore, Wang teaches plasticizing agents in an amount of 0.75-50% (col. 15, ln. 58-col. 16, ln. 2).
Regarding claim 10, Wang teaches an amount of therapeutic agent of about 0.01-75% (col. 15, lns. 50-56).
Regarding claim 11, Wang teaches an amount of therapeutic agent of about 0.01-75% (col. 15, lns. 50-56), where it is interpreted that the remaining amount may be excipients, falling within the range of 5-20%. Wang teaches plasticizing agents in an amount of 0.75-50% (col. 15, ln. 58-col. 16, ln. 2).
Regarding claim 12, the composition may comprise everolimus (col. 10, ln. 38).
Wang does not teach an exact combination of a therapeutic agent, plasticizing agent, and polycaprolactone or poloxamer in claim 1.
In regards to selecting the combination of a therapeutic agent and polycaprolactone or poloxamer in claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Wang teaches (entire teaching) a drug releasing coating (title) comprising polycaprolactone (col. 6, ln. 66-col. 7, ln. 4), a plasticizing agent (col. 4, lns. 58-61), and a therapeutic agent (abs), whereas the claimed invention is directed towards an elutable coating composition comprising a plasticizing agent, polycaprolactone or poloxamer, and a therapeutic agent. Since Wang teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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