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
Applicant’s election of the Composition of Claims 1-14 in the reply filed on 17 February 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Further acknowledgement is made of applicant’s election of poly(ester amide urea) of Claims 1-3 as the species of polymer to be employed in the biodegradable polymeric nanospheres of the instant claims.
Status of the Claims
Claims 1-14 are pending, presented for examination, and rejected as set forth below.
Priority
The instant application claims the benefit of Provisional US application 63/489,345 filed 9 March 2023.
Claim Rejections - 35 USC § 112(b)
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.
Claim 12 is 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 12 recites the limitation "the surfactant" in Claim 10. There is insufficient antecedent basis for this limitation in the claim as no surfactant is required by Claim 10. The Examiner suggests applicants meant for Claim 12 to depend from Claim 11, but cannot be certain. Appropriate correction is required.
Claim Interpretation
Applicants claims are directed to compositions comprising an NSAID encapsulated in a biodegradable polymeric nanosphere which includes a poly (ester amide urea) as a component of the nanosphere. Dependent Claims 2 and 3 narrow the identity of the poly (ester amide urea). Claim 4 adds a functionally defined permeation enhancer to the composition, with Claim 5 indicating that the composition is provided in a form suitable for local application to the skin. Claims 6-8 narrow the size of the nanospheres present in the composition, with Claims 9 and 10 narrowing the amount and identity of the NSAID, respectively. Claims 11-14 require the inclusion of a surfactant and co-surfactant, PVP and polysorbate 80 respectively, as well as the concentration of each to be present in 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 1-3 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tawil (U.S. 10,849,944), in view of Katsarava (U.S. PGPub. 2016/0375139), and Sengupta (WO2005/084710).
Tawil describes polymeric encapsulates for bioactive ingredients. (Abs.). painkillers are among the drugs listed as suitable for inclusion in these encapsulates. (Col.11, L.21-23). Biodegradable polyester amide ureas are described as particularly suitable polymers for such use, (Col.2, L.35-49), with the following random copolymer being a particular polyester amide to be used. (Col4, L.25-39).
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Identical to the instant claims, Tawil indicates that in particularly preferred embodiments, R1 is to be –(CH2)6-, R3 –(CH2)8-, and each of R2 and R4 are L-leucine, addressing the polymer limitations of Claims 1-3. (Col.7, L.40-44). Tawil indicates that the compositions may incorporate between 0.1-10% PVA as a surfactant used to form the capsules, addressing limitations of Claims 11-14. (Col.8, L.1-4; Col.15, L.48 – Col.16, L.9). Tawil indicates that these compositions may be formulated as wound dressings that can be applied to surface wounds, addressing limitations of Claim 5. (Col.15, L.55 – Col.16, L.13).
Tawil therefore describes drugs such as painkillers encapsulated within the random poly(ester amide urea) copolymers of the present claims. Tawil does not specify that these are nanoparticles, let alone nanoparticles of the defined size, nor that the drug is to be an NSAID or that polysorbate 80 may be included as a co-surfactant.
Katsarava also describes the random poly(ester amide urea) copolymers of the present claims as well as the Tawil reference. [0069; 0076]. Katsarava indicates these copolymers compatible with a wide variety of bioactive agents including NSAIDs. [0249]. Katsarava indicates these compositions are, like those of Tawil, useful for providing topical drug delivery systems like wound dressings, patches, sprays, gels, and ointments. [0292-95; 0524].
While Katsarava indicates that NSAIDs are drugs compatible with the poly(ester amide ureas) polymers of Tawil and the instant claims, and are taught as suitable for topical administration, neither Tawil nor Katsarava describes the formulation of these polymer/agent combinations as nanoparticles.
This is cured by the teachings of Sengupta, which describes the use of nanoparticulates formulated from any of polyesters, polyamides, and polyureas to provide for the slow, sustained release of therapeutic agents associated with the nanocores. (Pg.6). Sengupta describes these cores as having a diameter of approximately 10-20,000 nanometers (Id.), but more preferably in the range of 50-5,000nm, a range overlapping and therefore rendering obvious the limitations of Claims 6-8. (Pg.20), See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Sengupta indicates that suitable active agents include non-steroidal anti-inflammatory agents, and specifically enumerate the ibuprofen of the instant claims as a suitable active agent. (Pg.27). Sengupta indicates that topical ointments and transdermal drug delivery systems serve as embodiments of compositions as which these nanoparticles may be provided. (Pg.32). While no particular concentration of active agent is required by the art of record, it must be remembered that NSAIDs and ibuprofen are described as therapeutic active agents which impart therapeutic properties to the compositions into which they are incorporated. On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by the teachings of Tawil, Katsarava, and Sengupta. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
The art at the time the instant application was filed establishes that the polymers of the instant claims, a random combination of poly(ester amide urea) known in the art, were useful as not only topical drug delivery films but which also encapsulate active agents. Active agents compatible with such polymeric dosage forms include nonsteroidal anti-inflammatory agents and specifically the ibuprofen of the instant claims. The art also establishes that nanoparticles of polyesters, polyamides, and polyureas were known to beneficially provide for the slow, sustained release of active agents like ibuprofen from nanoparticles containing those types of drugs. On this basis it must be remembered that “[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)). “[W]hen 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 prima facie obvious to have selected to provide ibuprofen as a therapeutic agent contained within a poly(ester amide urea) copolymer nanoparticle within a topical or transdermal drug delivery composition according to the instant claims, to arrive at compositions “yielding no more than one would expect from such an arrangement.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Tawil, Katsarava, and Sengupta as applied to claims 1-3 and 5-10 above, and further in view of Schobel (WO2011/156711).
Tawil, Katsarava, and Sengupta, discussed in greater detail above, suggest compositions combining ibuprofen as a therapeutic agent contained within a poly(ester amide urea) copolymer nanoparticle within a topical or transdermal drug delivery composition, but does not specify the composition should contain a penetration enhancer, or should contain combinations of surfactant and co-surfactant such as the combination of PVA and polysorbate-80 recited by Claims 11-14.
However, Sengupta does indicate that at the time the instant application was filed, polysorbate-80 (recited as “TWEEN 80”) was known to be useful as a surfactant in pharmaceutical compositions. This is combined with the teachings of Schobel, which establishes that in addition to the surfactant properties possessed by polysorbate-80, this compound was additionally known to act as a penetration enhancer for transdermal drug delivery vehicles. (Pg.41, L.21 – Pg.42, L.1). Schobel indicates that these permeation enhancers, including the polysorbate-80 of the instant claims, should be included in transdermal drug delivery compositions in concentrations falling within the range of about 0.01-15% of the composition, overlapping and therefore rendering obvious the limitations of the present claims. (Pg.44, L.27 – Pg.45, L.2), see Peterson, supra.
It therefore would have been prima facie obvious to have incorporated PVA in concentrations recited by the instant claims as well as polysorbate-80, also in concentrations recited by the instant claims, into the transdermal ibuprofen poly(ester amide urea) nanoparticle compositions suggested by Tawil, Katsarava, and Sengupta. This is because Tawil specifically teaches the inclusion of PVA in the claimed amounts, Sengupta indicates that polysorbate-80 was known to serve as another pharmaceutically acceptable surfactant in transdermal drug delivery compositions, and Schobel indicates that including polysorbate-80 in the concentrations of the instant claims would additionally serve as a permeation/penetration enhancer for transdermally delivered active pharmaceutical agents. This is because not only does this combination appear to be the combination of two components known to be useful for the same purpose, namely as a pharmaceutical surfactant where a pharmaceutical surfactant’s use is indicated, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), but also that the incorporation of the claimed concentrations of polysorbate-80 with the PVA of Tawil would be expected to additional improve the penetration, uptake, and then bioavailability of the agents so formulated. See In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983) (“The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.”).
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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