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 .
Claims 14, 15 and 20-27 are presented for examination.
Claims 1, 3 , 6, 8-13 and 16 are withdrawn from consideration.
Restriction/Election
Applicant’s election without traverse of Group II, claims 13 and 14 in the reply filed on 01/09/2026 is acknowledged. Applicant added claims 20-27, which are dependent on elected claims 14 and 15 and will be examined with elected claims 14 and 15.
Claims 1,3, 6, 8-13 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/09/2026.
Claim Rejections - 35 USC § 103
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.
Claim(s) 14, 15 and 20-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sigmund et al. (US 2010172799) in view of Fernandez et al. ( WO 2017174437 submitted by the applicant) and further in view of McGinnis et al. (US 20110111007 submitted by the applicant) and Ando et al. (US 20230172969).
The claims are drawn to a pharmaceutical or veterinary composition comprising:
(a) single-crystal single cerium oxide nanoparticles of formula (I):
NP-(C)
(I), wherein
NP is a single-crystal single cerium oxide nanoparticle with a crystal diameter from 3 to 5 nm,
measured with transmission electron microscopy and X-Ray diffraction, and (C) is a coating of
citrate molecules adsorbed on the NP; and
(b) a pharmaceutically or veterinary acceptable citrate salt, together with pharmaceutically or
veterinary acceptable excipients and/or carriers.
Regarding claim 14, Sigmund teaches a citrate-coated metal oxide nanoparticles having free radical scavenging activity, which are useful for increasing the survival or viability of cells in vitro and in vivo. Sigmund teaches that Preferably, the nanoparticle is a citrate-coated cerium oxide nanoparticle. See Para [0007]. Sigmund teaches a composition comprising nanoparticles of the invention and cells of one or more types. Preferably, the nanoparticles are citrate-coated. More preferably, the nanoparticles are citrate-coated cerium oxide nanoparticles. The cells and/or composition can be therapeutic, intended for transplantation. See Para [0016]. The diameter of nanoparticle cerium adj oxide is taught to be are within the range of 3 nanometers and 7 nanometers in diameter. See Para [0015]. Sigmund teaches that In accordance with the invention, free radical scavenging particles can be used as agents to increase the numbers of preserved cells in transplantation of cells; to enhance the viability of transplanted organs both prior to transplantation, i.e., during transport and in vivo after transplantation; to enhance viability and/or function of cell based tissue substitutes; to improve cells' or organisms' lifespans; to improve animals' or humans' health; to improve animals' or humans' lifespan; for anti-aging; for anti-inflammation; and cosmetics; and, optionally, can be used in conjunction with other effective agents. See Para [0018]. The use of carriers is taught in Para [0057]. Sigmund does not teach nanoparticle being in a single crystal.
However, Fernandez et al. teach the use of cerium oxide nanoparticles useful in the treatment of hepatocellular carcinoma (HCC), said nanoparticles being cerium oxide single-crystalline nanoparticles, wherein NP is a single-crystalline cerium oxide nanoparticle with a crystal diameter from 3 to 24 nm. See the abstract and claim 1. A pharmaceutical or veterinary composition comprising cerium oxide single-crystalline nanoparticles is taught in claim 15.
It would have been obvious to a person skilled in the art to use a single crystal single cerium oxide in the composition of Sigmund, motivated by the teachings of Fernandez, which teaches the single crystal single cerium oxide has been used in a pharmaceutical or veterinary composition. The measurement of the diameter by a specific method does not create a patentably distinct composition.
Regarding claim 15, Sigmund and Fernandez do not teach a topical eye aqueous colloidal suspension. However, McGinnis teaches methods for reducing, reversing or inhibiting retinal cell degeneration, or neovascularization in tissues of a mammalian subject having a pathological condition involving neovascularization, by administration in vivo of nanoceria particles (cerium oxide nanoparticles). See the abstract and Para [0048]. The intravitreal injection is taught in Para [0051]. The topical administration to the eye is taught in Para [0068]. The use of an aqueous suspension is taught in Para [0072]. It would have been obvious to a person skilled in the art to apply cerium oxide by topical administration, motivated by the teachings of McGinnis, which teaches the use of cerium oxide by topical administration to the eye in the form of an aqueous suspension.
Regarding claim 20, Fernandez et al. teach cerium oxide nanoparticles useful in the treatment of hepatocellular carcinoma (HCC), said nanoparticles being cerium oxide single-crystalline nanoparticles, wherein NP is a single-crystalline cerium oxide nanoparticle with a crystal diameter from 3 to 24 nm. See the abstract and claim 1.
Regarding claims 21 and 22, Sigmund teaches the use of sodium salt of citric acid in the composition comprising cerium oxide. See Para [0089].
Regarding Claim 23, McGinnis teaches the use of cerium oxide as an eye drop in an aqueous suspension. See Paras [0054] and [0072]. McGinnis does not teach that the composition being in a colloidal form. However, Sigmund teaches that synthesized nanoparticles require colloidal stabilization after removing the first surfactant in the washing step. Therefore, a specifically adsorbing compound was introduced into the system that cannot be washed out and is able to induce colloidal stabilization in aqueous systems. This compound is tri sodium citrate, i.e., the sodium salt of citric acid. Citric acid is fully biocompatible and part of the Krebs cycle in the cell. Therefore, nanocomposite particles comprising a coating of citrate around ceria are expected to be more biocompatible than ceria alone. See Para [0088]. Therefore, it would have been obvious to prepare the eye drop of McGinnis in a colloidal form, motivated by the teachings of Sigmund, which teaches the colloidal form of cerium oxide is more stable.
Regarding claim 24, McGinnis teaches the concentration of 1 nM to 1000 nM for cerium oxide. The 1 nM is about 1 mg/ml. However, the coating will add some to the concentration, which differs depending on the size of nanoparticles. Furthermore, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Applicant’s attention is drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), wherein the court states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Regarding claim 25, Sigmund does not teach the concentration of citrate salt. However, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 26, Sigmund teaches a composition comprises a carrier or vehicle, which can be a solvent or liquid dispersion medium comprising water, ethanol, a polyol (for example, glycerol, propylene glycol, liquid polyethylene glycols), vegetable oils, nontoxic glyceryl esters, and suitable mixtures thereof. See Para [0057]. Furthermore, Ando teaches an ophthalmic composition comprising amino methyl-propanediol. See Para [0093]. The use hydroxypropyl methylcellulose is taught in Para [[0079]. The use of benzalkonium chloride is taught in Para [0087]. The use of citrate is taught in Para [0093]. The use of solvents, such as water is taught in Para [0112]. It would have been obvious to use the components of claim 26 in combination with cerium oxide, motivated by the teachings of Ando, which teaches the use of such components in ophthalmic formulations as old and well known.
Regarding claim 27, Sigmund does not teach the use of a viscosity agent, such as hydroxypropyl methyl cellulose, a preservative, such as benzalkonium chloride or boric acid and surfactants, such as amino hydroxy methyl propanediol. However, Ando teaches an ophthalmic composition comprising amino methyl-propanediol. See Para [0093]. The use hydroxypropyl methylcellulose is taught in Para [[0079]. The use of benzalkonium chloride is taught in Para [0087]. The use of citrate is taught in Para [0093]. The use of solvents, such as water is taught in Para [0112]. It would have been obvious to use the components of claim 27 in combination with cerium oxide, motivated by the teachings of Ando, which teaches the use of such components in ophthalmic formulations as old and well known.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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, Sue Liu can be reached at 571-272-5539. 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.
/ZOHREH A FAY/Primary Examiner, Art Unit 1617
Prosecution Insights