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 with traverse of Group I in the reply filed on 7/6/2026 is acknowledged. Applicant’s traversal is on the basis that there would be no undue burden to search the groups together. Applicant’s arguments are not found persuasive because there would be an undue search burden for the reasons set forth in the restriction requirement which applicant has not addressed. The restriction requirement is therefore still deemed proper and is made FINAL.
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 20-39 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 term “characterized in that” that appears in claim 20 and the dependent claims is indefinite because it’s unclear how or in what way the phrase limits the claim. The phrase divides a claim into a pre-characterizing part and a post-characterizing part, and it’s unclear how the partition of pre-characterizing part and a post-characterizing limits the claims.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 20-39 are rejected under 35 U.S.C. 103 as being unpatentable over WO 01/39815 A2 to Szoka (document already in record) in view of Stefanick (ACS Nano, 2013; document already in record) in further view of Takayama (Am J Cardiol, 2016; document already n record). Szoka teaches a method of treating comprises: a nanocarrier delivery system is administered to a subject in need thereof comprising liposome nanocarrier delivery system (a medicament comprising the nanocarrier delivery system and pharmaceutically acceptable carriers; a diagnostic preparation characterized in that the diagnostic preparation comprises the nanocarrier delivery system) comprising an agent for the treatment of disease (abstract) characterized in that the surface of the nanocarrier is partially modified by a targeting ligand, and the targeting ligand is a ligand capable of specifically binding to an activated CD44 molecule (page 7, lines 8-17; page 8, lines 6-27; page 12, line 13). The system may comprise 125I (an iodine-based nanoscale contrast agent) page 16, line 25) or MRI contrast agent (an MRI tracer; MRI contrast agents work by longitudinal relaxation, transverse relaxation, or a combination thereof (page 4, lines 26-27). The liposomes may be small unilamellar, large unilammellar, or multi-lamellar vesciles (page 7, lines 15-17). The substance may be a regulator of CD44 (a CD44 activator) (page 6, lines 4-20). The targeting ligand may be hyaluronic acid (page 5, line 4). The hyaluronic acid may have a molecular weight of less than about 5,000 (less than 5Kda) (page 7, lines 8-12). The substance may be a drug or polypeptide (page 3, line 32; page 21, lines 28-32). The liposome nanocarrier delivery system may comprise a hyaluronan ligand with an affinity for CD44 receptors (abstract). The system may comprise anti-inflammatory agents (an active pharmaceutical ingredient for treating vulnerable plaques) (page 8, lines 25-27). The system may be a diagnostic preparation (page 3, lines 32-33). The system is part of a medicament comprising water (a pharmaceutically acceptable carrier) (page 3, lines 32-33; page 24, lines 19-29). The composition may comprise PEG (page 23, lines 4-32).
Szoka fails to teach incorporation of a targeting ligand such as hyaluronic acid, and further fails to teach a molecular weight a hyaluronic acid in the range of 2-20 kDa (claim 45) or 2-10 KDA (claim 60), and further fails to teach “wherein the surface comprises PEG.”
Takayama teaches that rosuvastatin is a well-established therapeutic agent for treating vulnerable plaques (Title; Abstract; pages 1207-1209).
Sefanick teaches that modifying the surface of liposomal delivery vehicles with PEG provides the advantage of imparting stealth to the particles for longer circulation times and to act as a linker connecting targeting ligands to the particle (abstract; page 2936, left column, first paragraph).
It would have been obvious to one of ordinary skill in the art to incorporate rosuvastatin into the composition for the treatment of vulnerable plaques. The motivation for this would be that rosuvastatin is well known for the treatment of vulnerable plaques, and by incorporating rosuvastatin into the composition, vulnerable plaques may be treated. It would have been further obvious to incorporate a targeting ligand such as or similar to hyaluronic acid into the formulation for treatment of vulnerable plaques, with the motivation being that vulnerable plaques may be treated. It would have been further obvious to incorporate a mAb into the nano carrier delivery system. The motivation for this is that mAb is effective at treating disease. It would have been further obvious to optimize the molecular weight of hyaluronic acid in the nanocarrier delivery system of Szoka, and in this way, find 1-20 KDa, 2-10 kDa, and 2-20 kDA through routine experimentation. The prior art provides sufficient guidance to this end, as Szoka teaches a hyaluronic acid molecular weight range of less than 5kDa, which overlaps with the present ranges. It would have been further obvious to one of ordinary skill in the art at the time the invention was made to modify the formulation of Szoka to provide wherein the surface comprises PEG. The motivation for this is that doing so would provide the advantage of improved circulation times and a means to connect targeting ligands to the particle.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 20-39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of Patent US 12642875. Although the conflicting claims are not identical, they are not patentably distinct from each other because the patent claims recite liposome nanocarrier delivery system wherein the surface of the nanocarrier is partially modified by a targeting ligand; wherein the targeting ligand is a hyaluronic acid, a pharmaceutically acceptable salt of the hyaluronic acid, or a Cl to C6 alkyl ester of the hyaluronic acid; wherein the hyaluronic acid, pharmaceutically acceptable salt of the hyaluronic acid, or Cl to C6 alkyl ester of the hyaluronic acid has a molecular weight in the range of 1-20 KDa; wherein the nanocarrier further comprises a long-chain phospholipid and cholesterol; and wherein the nanocarrier is loaded with rosuvastatin, or a pharmaceutically acceptable salt. This anticipates the present claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
August 19, 2026
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