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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on October 29, 2025 is acknowledged.
Claims 26, 28-32, 34-37, and 40-43 are pending in this application.
Claims 1-25, 27, 33, and 38-39 have been cancelled.
Claims 26, 36, and 41-43 have been amended.
All pending claims are under examination.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on January 6, 2026 is acknowledged. A signed copy is attached to this office action.
Withdrawn Objections/Rejections
Abstract
The objection to the abstract because the abstract should be a concise summary of the key technical aspects of the invention which are new of the art to which the invention pertains has been withdrawn in view of the amendment to the abstract to recite key technical aspects of the composition of the invention.
Claim Rejections - 35 USC § 112
The objection to claims 38-39 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends has been withdrawn in view of the cancellation of the claims.
Claim Rejections - 35 USC § 103
The rejection of claims 26-39 and 43 under 35 U.S.C. 103 as being unpatentable over Evjen et al. (US2012/0288557) in view of Hauser (Spontaneous vesiculation of uncharged phospholipid dispersions consisting of lecithin and lysolectin, Chemistry and Physics of Lipids, Vol 43, Issue 4, May 1987, pages 283-299) has been withdrawn in view of the arguments regarding the molar ratio (mole %) of the DOPE.
The rejection of claims 40-41 under 35 U.S.C. 103 as being unpatentable over Evjen et al. (US2012/0288557) in view of Hauser (Spontaneous vesiculation of uncharged phospholipid dispersions consisting of lecithin and lysolectin, Chemistry and Physics of Lipids, Vol 43, Issue 4, May 1987, pages 283-299) as applied to claims 36-39 and 43 above, and further in view of Zhang (Thin-film hydration followed by Extrusion method for Liposome Preparation, Methods in Molecular Biology, pgs. 17-22, 12 November 2016) has been withdrawn in view of the arguments regarding the molar ratio (mole %) of the DOPE.
The rejection of claim 42 under 35 U.S.C. 103 as being unpatentable over Evjen et al. (US2012/0288557) in view of Hauser (Spontaneous vesiculation of uncharged phospholipid dispersions consisting of lecithin and lysolectin, Chemistry and Physics of Lipids, Vol 43, Issue 4, May 1987, pages 283-299) as applied to claims 36-39 and 43 above, and further in view of Zhang (Thin-film hydration followed by Extrusion method for Liposome Preparation, Methods in Molecular Biology, pgs. 17-22, 12 November 2016) and Tasi et al. (Microcalorimetric investigation of the interaction of polysorbate surfactants with unilamellar phosphatidylcholines liposomes, Colloids and Surfaces A: Physicochem Eng Aspects 213 (2003):7-14) has been withdrawn in view of the arguments regarding the molar ratio (mole %) of the DOPE.
Double Patenting
The rejection of claims 26-43 on the ground of nonstatutory double patenting as being unpatentable over claim 1-10, 17, 19-23, and 29 of copending Application No. 17/997,384 has been withdrawn in view of the acceptance of the Terminal Disclaimer.
Newly Applied Rejections
Claim Rejections - 35 USC § 112
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.
Claims 41-42 are 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.
The dependency of the claims has been amended to claim 26, which is a composition of matter and not a method claim. Therefore, it is unclear what the metes and bounds of the claim are. Clarification is requested.
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 26, 28, 29, 31-32, 34-37, 40, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds et al (US 2018/0236075).
Reynolds discloses acoustically activated liposome compositions for use in driven drug delivery vehicles (abstract).
The liposome composition may be used for delivery through the blood brain barrier (paragraph 0029).
The liposome composition may comprise liposomes formulated from a composition comprising a phospholipid and a sphingomyelin. The phospholipid can include 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE) (paragraph 0154).
The recitation of “wherein the sonosensitive liposomes of (i) or (ii) penetrate the blood brain barrier opened by the cavitation of ultrasound” is considered a functional property and a necessary result of the liposomes.
Regarding claim 28-29, the instant claims do not require the components recited. Therefore, the claim limitations are considered optional.
Regarding claims 30-31, DSPE—PEG2000 can be added as a lipid component. The ratio of the phospholipid to the lipid may be 100:1 to 1:1 (paragraph 0017).
Regarding claim 32, mean particle diameter of the liposomal structures range from about 20 to about 500 nm (paragraph 0139; 0185).
Regarding claim 34, the claim recites an intended use of the liposomes and is therefore, not given patentable weight.
Regarding claims 35-36, any number of different agents can be contained or encapsuled with the liposomes which can act as a carrier for the agents (paragraph 0200). Examples include vincristine, vinblastine, vinorelbine, vindesine, paclitaxel, docetaxel, carbidopa, dopamine agonist, (paragraph 0212-0248) for example.
Regarding claim 37, the vesicles are prepared by vortexing a lipid film with an aqueous solution, such as a solution of ammonium sulfate (paragraph 0180).
Regarding claim 40, the preparation of liposomes include dissolving the lipids in chloroform (organic solvent), the solvent was evaporated. The resulting liposome can then be rehydrate with a phosphate buffer (paragraph 0557).
Regarding claim 43, as noted above, the drug encapsulated liposomes are disclosed as being delivered to the brain.
While Reynolds does not exemplify the liposomes of the instant claims, he does provide suggestion and motivation to prepare and use the liposomes since DOPE is considered an alternative to the exemplified phospholipids. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have prepared the liposomes according to the instant claims.
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 MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615