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 the Preliminary Amendment filed on October 6, 2025 is acknowledged.
Claims 1-4, 6-16, 19, 21-23, and 35 are pending in this application.
Claims 5, 17-18, 20, 23-34, and 36-41 are cancelled.
Claims 3-4, 6-11, 13-16, 19, 21-23 and 35 have been amended.
Claim Objections
Claims 4 and 13 are objected to because of the following informalities:
Regarding claim 4, the claim recites monoolein (glycerol monooleate). This recitation is redundant. The Examiner suggests one term be selected.
Regarding claim 13, the claim recites Pluronic F127 (poloxamer 407). This recitation is redundant. Applicant’s attention is directed to the 112(b) rejection below. Appropriate correction is required.
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 10 and 13 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.
Regarding claim 10, the claim recites “R is as defined in any one of claim 10 to claim 12”, however, claims 10-12 do not recite any R designations”. Therefore, it is unclear what the metes and bounds of the claim encompass.
Claim 13 contains the trademark/trade name Pluronic F127. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the hydrophilic nonionic surfactant poloxamer 407 and, accordingly, the identification/description is indefinite.
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 1-3, 6-11, 13-16, 19, 23, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mhule et al. (Synthetic of an oleic acid based pH-responsive lipid and its application in nanodelivery of vancomycin, Internation Journal of Pharmaceutics, 550 (2018) 149-159.
Mhule discloses a pH-responsive solid lipid, N-(2-morpholinoethyl) olemide (NMEO) was synthesized and used to prepare vancomycin (VCM)-loaded solid lipid nanoparticles (VMC_NMEO SLNs).
Regarding claim 2, the recitation of being “capable of” is not deemed a structural limitation and holds no patentable weight.
Regarding claims 3, 7 and 9-10, the nanoparticles comprising a compound falling within the scope of present formula (I) wherein:
Cyc is morpholinyl;
L is an amido linker further comprising a C2 alkyl carbon chain between Cyc and the amide group; and
R is an oleyl group, and
compositions thereof.
The compositions may comprise a dispersion of the lipid carrier in water (NMEO, figure 1, pg. 150; sections 2.2.3 and 2.2.7, pg. 151).
Please note that while the oleyl group has been incorrectly depicted as a C16 alkenyl carbon chain, the experimental protocol for the synthesis of the disclosed compound employs oleic acid as a starting material (section 2.2.1, pg. 150) and thus the person skilled in the art would recognize the depiction of the oley1 group of the aforementioned compound as erroneous.
Regarding claim 6, the drug load of the nanoparticles is disclosed to be 8.1% (section 3.4).
Regarding claim 8, the lipid compound disclosed in Mhule also falls within the scope of present formula (Ib) wherein Cyc is morpholinyl, R is an oleyl group (C17 carbon chain) and n is 2.
Regarding claim 11, the SLN’s were formulated with the oily phase consisting of NMEO as a solid lipid and vancomycin free base and the aqueous phase of surfactant solution in water (section 2.2.3). It is noted that surfactants act as stabilizers.
Regarding claim 13, the particles were compared to those prepared with Pluronic F127 (section 3.3.1).
Regarding claim 14, as noted above, vancomycin (VCM)-loaded solid lipid nanoparticles (VMC_NMEO SLNs) are disclosed.
Regarding claim 15, since Mhule disclose the same LLC lipid carrier, it would necessary also have the same properties as those recited in the instant claim.
Regarding claim 19, as noted above, the solid lipid particles are loaded with vancomycin.
Regarding claim 23, as noted above, the particles are in an aqueous carrier, which is a polar medium.
Regarding claim 35, Mhule discloses the use of the aforementioned lipid nanoparticle carriers in the delivery of vancomycin in vivo for the treatment of bacterial skin infection, wherein said lipid nanoparticle carriers exhibit improved binding to bacterial cells via their ability to acquire positive charge at pathological pH conditions, and wherein said lipid nanoparticle carriers further comprise a non-ionic triblock copolymer such as Lutrol F-68 (section 3.3.1, pg. 152; section 3.10, pg. 156-157).
Mhule, therefore, anticipates the rejected claims.
Claims 1-3, 7, 19, 23 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao et al. ([12]aneN3-based single aliphatic chain modified cationic lipids as gene delivery vectors, Tetrahedron, 2019, vol 75, no 5, pages 658-664).
Gao discloses a lipid carrier comprising an amino lipid falling in the scope of instant formula (I) wherein:
Cyc is 1,5,9- triazacyclododecane;
L is an amido linker; and
R is a C11, C13, C15 or C17 carbon chain (lauryl, myristyl, palmityl, stearyl or oleyl), and the use of said lipid carrier as a DNA delivery agent to cells in vitro ("Introduction", final paragraph, pg. 658-659; compounds lb-1f, scheme 1, pg. 659; "In vitro transfection by liposomes", pg. 660).
Gao further discloses compositions comprising the lipid carrier, wherein said compositions comprise a buffered aqueous suspension of the lipid carrier ("Preparation of cationic liposomes" and "Preparation of lipid/DOPE/DNA complexes (lipoplexes), pg. 662-663).
It is noted that the lipid carriers disclosed in Gao are prima facie obvious considered to exhibit the nonlamellar lyotropic liquid crystalline phase properties defined in the instant claims. additionally the lipid compounds disclosed in Gao are considered to be both structural lipids as specified in instant claim 1, as well as amino lipids comprising an amido linker, and that there is no requirement in present claim 1 that the specified lipids are two discrete compounds.
Regarding claim 2, the recitation of being “capable of” is not deemed a structural limitation and holds no patentable weight.
Regarding claim 3, as noted above, oleyl is disclosed.
Regarding claim 7, as noted above, Gao discloses a lipid carrier comprising an amino lipid falling in the scope of instant formula (I) wherein:
Cyc is 1,5,9- triazacyclododecane;
L is an amido linker; and
R is a C11, C13, C15 or C17 carbon chain (lauryl, myristyl, palmityl, stearyl or oleyl), and the use of said lipid carrier as a DNA delivery agent to cells in vitro.
Regarding claim 19, as noted above, the liposomes contain DNA.
Regarding claim 23, as noted above, the lipid carrier is in a buffered aqueous suspension.
Regarding claim 35, the LLC lipid carrier is used in gene therapy (Introduction).
Gao, therefore, anticipates the rejected claims.
Allowable Subject Matter
Claims 4, 12, and 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art is that of Mhule et al. which is discussed above.
Mhule does not disclose the lipid comprises glycerol monooleate. There is no motivation to substitute the N-(2-morpholinoethyl) olemide disclosed.
Mhule, additionally, discloses the surfactant is present in the amount of 0.26%. Therefore, it would not have been obvious, nor would there be motivation to add the surfactant in the amount of 10%.
Additionally, Mhule discloses antibiotic agents and not topoisomerase I inhibitors, there is no motivation or expectation of success in the substitution to the vancomycin in Mhule with a topoisomerase I inhibitor.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
Prosecution Insights