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 without traverse of Group I in the reply filed on September 2, 2025 is acknowledged.
Claims 63-71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The restriction is deemed proper and is therefore made FINAL.
Specification
The abstract of the disclosure is objected to because the permissible length is exceeded and it does not appear on a separate page.
Applicant is reminded of the proper language and format for an abstract of the disclosure. Specifically, the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 55-62 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.
Claim 58 recites “wherein the volume of solution contains an amount of a solvent and the quant contains no amount of the solvent”. The quant in the claimed formulation for treating a patient is in a volume of solution and is composed of amphiphilic interface molecules and component molecules. The amphiphilic molecules are arranged such that the hydrophilic portion faces away from the component molecules and the hydrophobic portion faces toward the component molecules in the quant. The only “solution” disclosed for a composition for treating a patient is an aqueous solution. It is not clear if the “contains no amount” recitation is an absolute recitation or means that the quant does not encapsulate the solvent of the solution. Tian et al. detail that amphiphilic compounds form micelles in aqueous medium where the hydrophilic portion forms the shell and the hydrophobic portion forms the core such that a hydrophobic/lipophilic drug can be encapsulated within the core (Journal of Materials Chemistry 200414:2317-2324, page 2317). Shukla et al. also describe the organization of these structures and note that the micelle has a hydrated shell that has water molecules hydrating the hydrophilic portion of the amphiphilic molecules and contributing to its hydrodynamic diameter (see Pharmaceutical Research 2002 19(6):881-886, page 881 first column-second column first full paragraph and figure 1). Tian et al. also detail that such micelles can be sensitive to their environment such that they destabilize when heated or do not even form when the external phase is made more hydrophobic (see page 2319 second column last partial paragraph-page 2320 and figure 4). Crosslinking the micelles can stabilize it against such changes; however, the external solvent still solvates the amphiphilic molecules such that hydrophobic external solvent swells the hydrophobic region on the interior of the micelle (see page 2320). Thus the external solvent is still associated with the amphiphiic molecules. For the sake of compact prosecution and the application of prior art, the recitation “quant contains no amount of the solvent” will be deemed as met if the quant of the prior does not encapsulate the solvent of the external solution in its core.
Claim 58 recites that in addition to a first quant, the composition comprises a plurality of additional quants that are “functionally identical” to the first quant. It is not clear in what way and to what degree the additional quants have to be the same as the first quant in order to meet this limitation. Claim 62 is similar in that it recites that in addition to a first quant, the composition comprises a plurality of additional quants that are “identical” to the first quant. It is not clear if these are absolute recitations or if there is some degree of variation permitted. The disclosure provides no criteria that are to be assessed to determine if a pair or set of quants are identical. As a result, the metes and bounds of the recitations are not clear. For the sake of compact prosecution and the application of prior art, a set or pair of quants (micelle droplets) present within a population of quants that are made and are counted in the same size band of a size distribution will be deemed sufficient to meet the limitations of being identical and being functionally identical. Clarification is still required.
Claim 59 recites “the second concentration of the solvent within the quant is in equilibrium with the first concentration of the solvent that is within the amount of solution”. The meaning of “equilibrium” in this context is unclear. For example, it could refer to the two concentrations being the same as well as the two concentrations being stable, even if different.
Claims that are rejected but are not elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 55-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (International Journal of Pharmaceutics 1999 181:173–179) as evidenced by Kahlweit (Science 1988 240(4852):617-621).
Park et al. disclose an oil-in-water microemulsion of the poorly water soluble drug flurbiprofen (component molecules) (see abstract and age 174 first column first full paragraph-last partial paragraph; instant claim 57). Poly(ethylene oxide) 20 sorbitan monolaurate, called Tween® 20, is present as the surfactant (amphiphilic interface molecule), where the poly(ethylene oxide) segment is the hydrophilic portion and the sorbitan monolaurate segment is the hydrophobic portion (see page 174 second column first-last full paragraphs). An oil solution of the Tween® 20 and flurbiprofen is prepared and dispersed as droplets (quants) into a saline aqueous solution to generate the microemulsion (see page 174 second column last full paragraph). Kahlweit details that the dispersed phase of such microemulsions orient a plurality of amphiphilic compound molecules at the oil/water interface with the hydrophilic portion facing the water/aqueous surface and the hydrophobic portion in the oil (see page 617 first column). Thus the hydrophobic portion of the amphiphilic interface molecule points toward the flurbiprofen component molecules and the hydrophilic portion of the amphiphilic interface molecule points away from them (see instant claim 55). An embodiment with a 1 wt% flurbiprofen loading in the formulation has droplet (quant) sizes between 62 and 132 nm and multiple droplets in each tabulated size band (identical/functionally identical ) (see figure 1; instant claims 56 and 58). Therefore claims 55-58 are anticipated by Park et al. as evidenced by Kahlweit.
Claims 55-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (Drug Delivery 2007 14:301–308) as evidenced by Kim (Journal of Pharmaceutical Investigation 2016 46:387–392).
Yang et al. disclose liposomes (quants) encapsulating the poorly water soluble drug paclitaxel (component molecule) (see abstract; instant claims 59 and 61). They are prepared from a mixture of phosphatidylcholine lipid compounds (amphiphilic interface molecules) with fatty acid tails and paclitaxel cast into a film that is hydrated in an aqueous solution (see page 302 first column last paragraph). The phosphate group is the hydrophilic portion and the fatty acid tail is the hydrophobic portion of the lipid compound (amphiphilic interface molecule). The result is a lipid bilayer encapsulating a portion of the aqueous solution in its core that is also present outside the liposome (equilibrium) (see Kim page 387 second column last partial paragraph-page 388; instant claim 55). Kim details that hydrophobic drugs encapsulated by liposomes are located in the lipid bilayer, where the hydrophobic tails of the lipids point toward the interior of the bilayer and the hydrophilic heads are located at and point toward the aqueous core and exterior (see figure 1). Thus the hydrophobic portion of the amphiphilic interface molecule points toward the paclitaxel component molecules and the hydrophilic portion of the amphiphilic interface molecule points away from them (see instant claim 59). Yang et al. measure the size of the liposomes and see that they are stable over time (equilibrium between core and exterior) and are sized at about 190 nm (see page 305 first column and figure 1; instant claim 60). They employ a Gaussian analysis to analyze the spread of the size measurements and obtain a narrow distribution which implies the occurrence of multiple liposomes (quants) at a given measured size within the distribution (see page 302 second column second full paragraph; table 1; instant claim 62). Therefore claims 59-62 are anticipated by Yang et al. as evidenced by Kim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 55-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 20 of U.S. Patent No. 11,707,737.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite quants composed of a solvent system that incudes a component molecule and amphiphilic interface molecules that are dispersed in an aqueous solution. The quants are sized at 20 to 300 nm and are uniform (identical/functionally identical), while the component molecule is recited as a drug , lipid, protein, antibody, isotope, nucleic acid sequence or a combination. The amphiphilic interface molecules have a hydrophobic portion and hydrophilic portion when the latter points toward the aqueous solution and the former points toward the solvent that also houses the component molecules. Therefore claims 55-58 are unpatentable over claims 1, 3-4, and 20 of U.S. Patent No. 11,707,737.
Conclusion
No claims is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615