DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group VI in the reply filed on 2/23/2026 is acknowledged. Applicants elect the species homogenous distribution. The species election has been withdrawn.
Claims 17-30 are pending.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 12/13/2023 is acknowledged.
Claim Rejections- 35 USC § 103
3. 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 17-18, 20-21, 24-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao, Zhen (US Patent 11696952) in view of CN103751148 and Devries et al. (WO2020036993).
Xiao, Zhen (US Patent 11696952) (hereinafter Xiao) teaches treating ocular diseases such as wet macular degeneration by administration of nanocapsules (abstract and col. 1, lines 16-25). The nanocapsules are constructed of a hydrophobic polymer (col., lines 45-46). A therapeutic substance is encapsulated. The shell may enable the release of the therapeutic agent and are also triggered to release highly controlled and reproducible amounts (e.g., radiation). The diameter of the nanocapsules can be from about 10 to about 1000 nm.
Claims 25 and 27 recite “can be” which is a future active step that the composition can do. Since the same structure of the nanocapsules is taught it is capable of doing the same.
Xiao does not teach polyurethanes.
CN103751148 disclose that polyurethane has good biocompatibility and excellent physical and mechanical properties, and has good physiological acceptability to the human body. The physical and chemical properties of polyurethane can be changed by changing the composition of soft and hard segments in the molecular chain. In addition, polyurethane microspheres have a microphase separation structure, good biocompatibility, high elasticity and high strength, so they can be used as carriers for proteins, antibodies, enzymes, etc., and drug controlled release. With regards to claim 30, the method on which the nanocapsules are produced is given little patentable weight to a treatment claim as the claim is directed to methods of treating wet AMD and the combined teachings of Xia and CN103751148 disclose polyurethane nanocapsules.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include polyurethane as the hydrophobic nanocapsule of Xiao. One would have been motivated to do so because they have good biocompatibility and excellent physical and mechanical properties.
Xiao does not teach the therapeutic is pirfenidone or acriflavine.
Devries et al. (WO2020036993) (hereinafter Devries et al) disclose pirfenidone is administered to treat an eye-related disorder and treat wet age-related macular degeneration.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the therapeutic agent be that of pirfenidone. One would have been motivated to do so because it is recognized to treat wet age related macular degeneration.
4. Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao, Zhen (US Patent 11696952) in view of CN103751148 and Devries et al. (WO2020036993) as applied to claims 17-18, 20-21, 24-28 and 30 above, and further in view of Bucolo et al. “Ocular drug delivery: a clue from nanotechnology” and Barar et al. “Advanced drug delivery and targeting technologies for the ocular diseases”.
The modified Xiao has been discussed supra and does not disclose the nanocapsules are administered intravitreally.
Bucolo et al. “Ocular drug delivery: a clue from nanotechnology” (hereinafter Bucolo et al. disclose that nanosystems are also useful for intravitreal injection delaying the clearance of the drug and reducing the need for repeated injections, thereby lowering the risk of complications. The intravitreal route is widely used to deliver therapeutic molecules to the retina.
Barar et al. “Advanced drug delivery and targeting technologies for the ocular diseases” (hereinafter Barar et al.) disclose that intravitreal injection is the main treatment modality of the disabling ocular diseases such as age-related macular degeneration (AMD).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to deliver the nanocapsules of Xiao intravitreally. One would have been motivated to do so because it would reduce the need for repeated injections and provide a way to deliver the drug directly to the retina and is a well-known treatment modality for diseases such as AMD.
5. Claims 17 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao, Zhen (US Patent 11696952) in view of CN103751148 and Devries et al. (WO2020036993) as applied to claims 17-18, 20-21, 24-28 and 30 above, and further in view of Amoozgar et al. (WO 2016025922).
The modified Xiao has been discussed supra and does not disclose that the nanocapsules are PEGylated. Amoozgar et al. (WO 2016025922) (hereinafter Amoozgar et al.) disclose the purpose of PEGylation is to resist rapid bodily clearance (i.e., stealth) (para 000156).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the nanoparticles of Xiao be PEGylated as taught by Amoozgar et al. One would have been motivated to do so in order to evade bodily clearance.
6. Claims 17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao, Zhen (US Patent 11696952) in view of CN103751148 and Devries et al. (WO2020036993) as applied to claims 17-18, 20-21, 24-28 and 30 above, and further in view of Carpentier (WO 2018202889).
The modified Xiao does not teach contrast agent. Carpentier (WO 2018202889) discloses contrast agent are substances that enhance contrast between the region containing the agent and the surrounding tissue in an ultrasound. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to further include a contrast agent in the nanocapsules of Xiao for the purpose of enhancing contrast between the region containing the agent and surrounding tissue.
7. Claims 17 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao, Zhen (US Patent 11696952) in view of CN103751148 and Devries et al. (WO2020036993) as applied to claims 17-18, 20-21, 24-28 and 30 above, and further in view of Alexey et al. (JP 2020050663).
The modified Xiao does not teach antimicrobial agent.
Alexey et al. (JP 2020050663) disclose treating conditions inclusive of wet age related macular degeneration and disclose inclusion of antimicrobial agents. Alexey et al. disclose antimicrobial agents, as used herein, inhibit, prevent, or inhibit bacteria, microbes, fungi, viruses, spores, yeast, mold, and other microorganisms commonly associated with infectious diseases. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to further include an antimicrobial agent in the nanocapsules of Xiao. One would have been motivated to do so to prevent and inhibit microorganisms associated with infectious diseases.
8. Claims 17 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao, Zhen (US Patent 11696952) in view of CN103751148 and Devries et al. (WO2020036993) as applied to claims 17-18, 20-21, 24-28 and 30 above, and further in view of Deckers et al. “Ultrasound triggered, image guided, local drug delivery”.
Xiao has been discussed supra and does not disclose ultrasound to release the molecule.
Deckers et al. “Ultrasound triggered, image guided, local drug delivery” (hereinafter Deckers et al.) disclose ultrasound triggered drug delivery (abstract). It is a non-invasive way used for local drug release (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use ultrasound to release the bioactive therapeutic agent. One would have been motivated to do so because it is a non-invasive way that is used for local drug delivery.
CORRESPONDENCE
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615