DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 08 July 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The indefiniteness rejections are withdrawn in view of the amendment to the claims. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 1, 5-8, 31-32, 34, and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Fujii et al. (US Patent Application Publication 2014/0287022).
Fujii et al. discloses liposomal compositions (abstract). The liposomes can have particular average sizes, which preferably is between 50 and 500 nm in diameter (paragraph [47]). Thus the liposomes disclosed are nanosized and read upon the nanoparticles recited by independent instant claim 1. Further, since the disclosed composition has liposomes, there is a lipid shell encapsulating an aqueous core (as this is the arrangement of liposomes).
The liposomes can comprise imiquimod (paragraph [40]), and imiquimod is the elected species of imidazoquinoline. Fujii et al. also suggests that the liposome can comprise, as part of the liposome, adjuvants (paragraph [148]), with interleukin-2 being one such suggested adjuvant (paragraph [151]).
Fujii et al. thus discloses compositions comprising the individual elements instantly recited by claim 1 (liposome comprising imiquimod and interleukin-2) and together these would provide a composition as instantly claimed. However, Fujii et al. is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been prima facie obvious, however, to make the combination since each component is taught as being useful in making the compositions of the prior art. Since this modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions a prima facie case of obviousness exists. See MPEP 2141.
Instant claims 5, 32, and 34 further limit the imidazoquinoline, and the imiquimod disclosed by Fujii et al. reads upon this limitation.
Instant claim 31 further limits the protein cytokine, and the IL-2 disclosed by Fujii et al. reads upon this limitation.
Instant claim 6 recites the further inclusion of a polymer such as polylactic acid, and Fujii et al. also suggests that the liposome can comprise, as part of the liposome, carriers (paragraph [148]), with polylactic acid being one such suggested carrier (paragraph [149]).
Instant claims 7 and 36 recite the further inclusion of a targeting moiety, and antigenic polypeptides are suggested as included in the liposome by Fujii et al. (paragraph [114]).
Instant claims 8 and 37-38 further limit the composition, where the liposomes are an aqueous solution with a certain pH range. Fujii et al. suggests using aqueous carriers for the liposomes, including water, saline, and the like (paragraph [155]). An example has a pH of 7.4 (paragraph [197]), which reads upon the limitation instantly recited.
Claims 2 and 33 are (and above rejected claims 1, 5-8, 31-32, 34, and 36-38 are) rejected under 35 U.S.C. 103 as being unpatentable over Fujii et al. (US Patent Application Publication 2014/0287022) as applied to claim 1 above, and further in view of Holldack et al. (US Patent Application Publication 2016/0331743).
Instant claims 2 and 33 recite the further inclusion of a cyclodextrin. While Fujii et al. discloses various excipients (paragraph [148]), cyclodextrin is not suggested therein.
Holldack et al. discloses pharmaceutical compositions comprising imiquimod (abstract). Holldack et al. suggests including cyclodextrins (such as β-cyclodextrin) with the imiquimod preparation, as the cyclodextrin enhances the solubility of the imiquimod (paragraph [62]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included β-cyclodextrin in the formulation disclosed by Fujii et al. Doing so would provide for the benefit of enhanced solubility for the imiquimod.
Claim 35 is (and above rejected claims 1, 5-8, 31-32, 34, and 36-38 are) rejected under 35 U.S.C. 103 as being unpatentable over Fujii et al. (US Patent Application Publication 2014/0287022) as applied to claim 1 above, and further in view of Dong et al. (US Patent Application Publication 2022/0152085).
Instant claim 35 recites the further inclusion of a polymer such as polyhydroxybutyrate. Fujii et al. suggests that the liposome can comprise, as part of the liposome, particulate carriers (paragraph [149]). But the specific polymer instantly recited is not taught.
Dong et al. discloses preparations for cancer and immune treatments (abstract). These include imiquimod (paragraph [124]) in liposomal carriers. And a specific polymer useful for the particulate carriers therein are poly-3-hydroxybutyrate and poly-4-hydroxybutyrate (paragraph [110]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included poly-3-hydroxybutyrate and poly-4-hydroxybutyrate in the formulation disclosed by Fujii et al. 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.
Response to Arguments
The Applicant argues that the rejections over Fujii et al. are not proper. The Applicant states that the list of adjuvants taught by Fujii et al. is long, and the specific combination as claimed is not suggested by Fujii et al. And this combination does not take into account the different ways adjuvants enhance immune responses. It is possible for two adjuvants to be effective individually but not effective when combined. Thus, one of ordinary skill in the art would not take for granted that these two could be used in combination.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The arguments relating to the combination of adjuvants suggested by Fujii et al. are not found persuasive. The Applicant argues that there are known exceptions to adjuvants being ineffective together. However, Fujii et al. suggests these adjuvants, and there is no suggestion from within the reference that any combination may not be as effective. Following the teaching of Fujii et al., the adjuvants would be expected to work. No evidence that the specific adjuvants at issue were known or expected to be problematic was provided, nor were any teachings of Fujii et al. cited to rebut the cited sections.
The Applicant also argues that Fujii et al. fails to teach how such a liposomal composition could be produced. The Applicant asserts that this is not straightforward. The technical challenges are not taught by Fujii et al. The Examiner does not consider this argument persuasive. Fujii et al. is presumed to demonstrate how to make liposomes. These are suggested, and no evidence that this art would have been unpredictable to one of ordinary skill in the art was provided.
The Applicant further discussed the solubility of the imiquimod, and states that Fujii et al. exemplifies the liposomes with a pH 7.4 buffer. And figure 1 of the instant application shows that imiquimod is barely soluble at such a pH. The Examiner does not consider this persuasive. Such a pH Is within the scope of the claims, and solubilization is not a requirement for the imiquimod in either the instant claims nor for Fujii et al.
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 Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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