DETAILED ACTION
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 . 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 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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2 and 5-8) and the species of imiquimod in the reply filed on 12 March 2026 is acknowledged. Claims 11-17, 20-23, 27-28, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claims 1-2 and 5-8 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Regarding claim 1 (and dependent claims), the phrase “a protein cytokine such as IL-2” renders the claim indefinite because it is unclear whether the limitations following the phrase “such as” are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 and 5-8 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 claim 5 further limits the imidazoquinoline, and the imiquimod 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 claim 7 recites the further inclusion of a targeting moiety, and antigenic polypeptides are suggested as included in the liposome by Fujii et al. (paragraph [114]).
Instant claim 8 further limits 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.
Claim 2 is (and above rejected claims 1 and 5-8 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 claim 2 recites 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 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 cyclodextrin in the formulation disclosed by Fujii et al. Doing so would provide for the benefit of enhanced solubility for the imiquimod.
Conclusion
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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