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 is the national stage entry of PCT/US2022/077022 filed 26 September 2022. Acknowledgement is made of the Applicant’s claim of domestic priority to provisional US application 63/261,599.
Status of the Claims
Claims 1-17 and 28-30 are pending.
Claims 1-4, 10-17, and 28 are rejected.
Claims 5-9 and 29-30 are allowable.
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 1-4, 10-17, and 28 stand rejected under 35 U.S.C. 103 as being unpatentable over Harris (US 2018/0071024) in view of Cunha et al. (Chem. Mater. 2013, 25, 2767−2776).
Harris teaches a composition that can comprise a plurality of photoreactive particles and a skin lightening agent wherein the particles have a concentration of 109-1013 particles per mL [0036]. The particles can be nanoparticles with a diameter in the range of from 10-900 nm [0056]. The agent (skin lightening agent) can be included in a therapeutically effective amount which can include the range of from 0.05-25% by weight or volume [0057]. Regarding the skin lightening agent, the agent can comprise monobenzone [0058]. The composition can also comprise a cosmetically acceptable carrier that can consist of surfactants such as lipids [0062]. Moreover, the nanoparticle can comprise a liposome and can encapsulate a material [0063]. In one embodiment, the nanoparticle can comprise solid metal particles [0026]. Moreover, the particles can be stabilized, thus implying a stabilizing agent [0027]. Harris teaches performing targeted enhancement of permeability of the nanoparticles and topically applying said nanoparticles in order to penetrate the skin surface [0065, 0082]. That being said, the composition can alternatively be administered by injection or orally [0112]. The particles are used to treat skin tissue and, in some embodiments, for the prevention and treatment of melanoma [0050].
Harris does not teach all the components in one formulation. Harris does not teach wherein the carrier is UiO-66.
Cunha teaches porous metal-organic frameworks (MOFs) for use in biomedicine (pg 2767, ¶1). In relation to caffeine as the active agent, it is taught that due to poor skin penetration the active is usually employed in emulsions, hydrogels, or liposomes (pg 2768, ¶2). Cunha has discovered that UiO-66, a MOF, are promising carriers for topical administration of caffeine (an active with poor skin permeation) with both spectacular cosmetic payloads and progressive releases (pg 2775, ¶2).
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 obvious to have selected various combinations of active agents, nanoparticles, stabilizing agents, and carrier agents from within Harris, to arrive at compositions “yielding no more than one would expect from such an arrangement.” The resulting composition would comprise a nanoparticle with active embedded within wherein the active can be monobenzone. The nanoparticle can comprise lipids or liposomes as the carrier and can also comprise a metal structure. The concentration of the active overlaps with the claimed amount, as required in instant claims 2 and 4. Regarding the diameter, Harris teaches a diameter that overlaps with that of the claimed invention but does not teach it to be a hydrodynamic diameter. In lieu of evidence to the contrary, the diameter taught in Harris is presumed to be accurate both in water and out of water, thus addressing instant claim 3. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I).
Since Harris teaches the particles can comprise metal, it would have been obvious to look to Cunha, which teaches a method for providing a nanoparticle with improved skim permeability wherein the particle comprises UiO-66 as the carrier. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07), thus addressing instant claims 10-15. The composition of Harris can be administered topically or by injection (systemically), for the treatment of melanoma, thus addressing instant claims 16-17.
Since Harris teaches the components of the nanoparticle, it would have been obvious to combine them together (the lipid carrier, the liposome carrier, the active monobenzone) to form a nanoparticle as required in claim 28.
Claims 1-4, 10-17, and 28 are accordingly obvious in view of the prior art.
Allowable Subject Matter
Claims 5-9, which require the monobenzone be modified at the benzyl ring para position appears to be free of the art. The prior art does not teach these modified monobenzone derivatives in a nanoparticle carrier. Regarding claims 29-30, the art does not teach forming the nanoparticule monobenzone in a free-dry process followed by an extrusion process.
Response to Arguments
Applicant's arguments filed 29 April 2026 have been fully considered but they are not persuasive. The Applicant argues, on page 5 of their remarks, that Harris fails to teach or suggest a nanostructured carrier and monobenzone embedded therein and that a person of ordinary skill would recognize that embedding and encapsulating are fundamentally different arrangements. The Applicant further argues, on page 6 of their remarks, that there is no articulated reasoning to explain how a person of skill in the art would have made the leap from the encapsulated configuration to arrive at the claimed embedded monobenzone.
In response, Harris teaches encapsulating the therapeutic agent (which can be monobenzone) in a nanoparticle so that it can be later released by heat causing the encapsulation layer to dissolve [0006]. Encapsulation is the complete covering of one thing (monobenzone) with another (nanoparticle). Encapsulation is a type of embedding wherein some or all of the active would be covered with the nanoparticle. Thus, encapsulation of the monobenzone reads on a form of embedding.
The Applicant argues, on page 6 of their remarks, that the Examiner does not explain why a person of skill would have selected monobenzone from the numerous broad categories and agents. On pages 7-8, the Applicant argues that there is no clear articulation of any reason why it would have been obvious to assemble the specific components of the claimed method.
In response, the Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When 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”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). That being said, the selection of monobenzone from among the prior art lists of active agents would have been obvious based on the cited case law.
The Applicant argues, on page 7 of their remarks, that Fig 8 shows liposomal material with embedded MBEH conjugate exhibits much greater cytotoxicity than unincorporated MBEH drug. The Applicant further argues that Fig 14 shows that cell viability is significantly reduced when exposed to UiO-66 loaded with monobenzone compared with monobenzone and UiO-66 alone.
In response, the data in Fig 8 is unclear as to the exact critical range in which the nanoparticle composition provides greater cytotoxicity than the free drug. As for Fig 14, cell viability clearly is enhanced in a more than additive way for the combination of monobenzone and UiO-66. That being said, the instant claims are much broader in scope than the data provided as the instant claims are broad to any carrier in any concentration with monobenzone. There is a fundamental requirement that must be met before secondary considerations can carry the day. "For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention." Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Takai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) ("If commercial success is due to an element in the prior art, no nexus exists."); Ormco Corp., 463 F.3d at 1312 ("[l]f the feature that creates the commercial success was known in the prior art, the success is not pertinent."); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990). Therefore, the data in Examples 8 and 14 does not amount to unexpected results that are sufficient in overcoming the pending obviousness rejection as the examples are not commensurate in scope with the claimed invention.
The Applicant argues, on page 7 of their remarks, that the instant claims do not require improved skin permeability, thus it would not have been obvious to combine Harris with Cunha.
In response, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In other words, the use of the claimed invention in the prior art does not need to be the same use as the instant claims which a are towards a composition of matter and not a method of use.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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