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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/24/2026 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35-40,50,56-57 and 60-73 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no description of reversing plaque growth nor a method “to reverse plaque growth in treating vulnerable plaques…” Applicant argues that support is found on page 37, lines 9-10, but these lines recite “administration at a dose of 20 mg atorvastatin per kg body weight… treatment by intravenous…” and nowhere describes the limitation above, nor is the limitation described in the limitation. Further, also, the scope of “a method to reverse plaque growth in treating vulnerable plaques” is not described, nor is there description of what falls under “a method to reverse plaque growth in treating…” the diseases listed. There is no description of what it means to “reverse plaque growth,” a complete elimination of the plaque, a partial elimination of the plaque, or reversal to a former state. There no description of reverse,” nor does the word “reverse” appear in the application.
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 35-40,50,56-57 and 60-73 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. It is unclear what is encompassed by “[a] method to reverse plaque growth i treating vulnerable plaques” and the subsequent listed diseases. It’s unclear what constitutes reversal in plaque growth, whether this means part of the plaque is eliminated, all of the plaque is eliminated, or if it is reversed to a certain state. If the later, it’s unclear what state it needs to revert to to be considered “reversed.” Further, there is no active step in the body of the claim wherein plaque growth is reversed. Further, it’s unclear if “to treat plaque growth in treating…” means plaque growth that arises as a result of the treatment, as evidenced by “…in treating…,” or it means a method of reversing plaque growth preexisting in a patient. For these reasons, the claims can be interpreted in different, non-overlapping ways, such as a requirement that plaque growth is reversed in the method, or if “to reverse plaque growth” is an intended use of the method. Further, vulnerable plaques in some cases may be a cause of “heart failure,” there are many other causes of heart failure as well. It’s unclear therefore if “heart failure” under the scope of the claimed invention involves only those cases where heart failure is caused by vulnerable plaques, or if it applies across the genus of “heart failure.” If it applies across the genus of heart failure, it’s unclear how one can reverse plaque growth in a condition that doesn’t have plaque growth in the first place.
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 35-40, 50, 56-57, 60-73 are rejected under 35 U.S.C. 103 as being unpatentable over WO 01/39815 A2 to Szoka (IDS filed 12/5/2024) in view of Stefanick (ACS Nano, 2013 IDS filed 8/1/2024) in further view of Takayama (Am J Cardiol, 2016). 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 treatment of one of the diseases enumerated in the claims, and further fails to teach incorporating hyaluronic acid or an active pharmaceutical ingredient enumerated in the present claims. Szoka further fails to teach a molecular weight of hyaluronic acid in the range of 2-20 kDa (claim 45) or 2-10 KDA (claim 60). Szoka 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 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. Regarding the recitation “…to reverse plaque growth,” for the purposes of applying the prior art, this recitation is considered to be an intended use of the method. As the claimed method steps are rendered obvious for the reasons given above, the method must be fully capable of carrying out the claimed intended use.
Conclusion
Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618 September 28, 2026
