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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 12/24/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
The application is examined in view of silica nanoparticle as specific porous nanoparticle and myelin oligodendrocyle glycoprotein peptide as specific self-antigen. Claims 1-5 read on the elected species and are under examination, claims 6 and 8 do not read on the elected species and are withdrawn from consideration.
Claims 1-6, 8, 10-20 are pending, claims 1-5 are under examination.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Koyakutty et al. (US20200246441) in view of Lee et al. (AU2020201037).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Koyakutty et al. teaches composition and method for treating multiple sclerosis (abstract). The invention provides a composition comprising a myelin oligodendrocyte glycoprotein (MOG) peptide coupled to or encapsulated into a carrier particle (page 2, [0016]). In some embodiments, the carrier particle comprises solid or porous silica and the particle diameter is 10-5000 nm (page 2, [0018]). In one embodiment, the composition is for vaccination (page 4, [0054]). In some embodiments, the nano- or micro-carrier containing silica is conjugated to or loaded with a modified
MOG 44~F antigen (page 5, [0066]). Biochemical analysis of a subject receiving a therapy as described herein may show a reduction in inflammation, demyelination and axonal damage within the central nervous system (page 8, [0096]). In one example, the silica nanoparticle is mesoporous nanoparticle (page 16, [0170]).
Lee et al. teaches mesoporous silica nanoparticle composite for biomedical treatment, including ceria nanoparticles, a method of producing the same, and a pharmaceutical composition. The mesoporous silica nanoparticle composite for biomedical treatment includes: mesoporous silica nanoparticles; cytokine loaded to the mesoporous silica nanoparticles; ceria nanoparticles loaded to the mesoporous silica nanoparticles; and liposome coated on the porous silica nanoparticles (abstract). The ceria nanoparticles have excellent antioxidant and anti-inflammatory effects to reduce mortality and tissue damage due to inflammatory diseases. The ceria nanoparticles may be loaded to the mesoporous silica nanoparticles. Specifically, the ceria nanoparticles may be physically and/or chemically bonded to the mesoporous silica nanoparticles ([0061-0062]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Koyakutty et al. is that Koyakutty et al. does not teach ceria nanoparticle bound to surface of porous silica nanoparticle. The deficiency of Koyakutty et al. is cured by Lee et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Koyakutty et al., as suggested by Lee et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to have ceria nanoparticle bound to porous silica nanoparticle because ceria nanoparticle bound to porous silica nanoparticle is known and suitable for drug delivery. MPEP 2144.07. Under guidance from Lee et al. teaching ceria nanoparticles loaded to the mesoporous silica nanoparticles with excellent antioxidant and anti-inflammatory effects to reduce mortality and tissue damage due to inflammatory diseases, since it is advantage to do, it is obvious for one of ordinary skill in the art to have ceria nanoparticle bound to porous silica nanoparticle and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-2, 4-5, Koyakutty et al. teaches a vaccine composition for the treatment of multiple sclerosis comprising a biocompatible mesoporous silica nanoparticle (mesoporous by definition having pore size of 2nm to 50nm) with particle size 10nm to 5000nm loaded with a myelin oligodendrocyte glycoprotein (MOG) peptide
Regarding ceria nanoparticle, prior art teaches ceria nanoparticle bound to porous nanoparticle, it is either inside or surface of porous silica nanoparticle, bound to the surface is obvious since it is one of only two choices.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Koyakutty et al. (US20200246441) in view of Lee et al. (AU2020201037), as applied for the above 103 rejection for claims 1-2 and 4-5, further in view of Yang et al. (CN109607554A, Machine translation) and Hong et al. (KR101724142B, Machine Translation).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Koyakutty et al. and Lee et al. teaching have already been discussed in the above 103 rejection and is incorporated herein by reference.
Yang et al. teaches that Polshettiwar et al initially reported macroporous silica nano-particles have fibrous pore structure in 2010 years, because such a macroporous silica nanoparticles compared with conventional mesoporous silica nanoparticles, having a central radially large pore structure gradually increases from the inner to the outer, high specific surface area, controllable pore diameter and pore volume, controllable grain diameter, better endocytosis performance and better biological degradability, so it can better absorb, carrying large space steric hindrance of the molecule or particle. The photosensitizer, biological macromolecule and inorganic nanometre particle and so on, to make it become a biological macromolecule delivery and tumor combined therapy of ideal material (page 2).
Hong et al. teaches a method for transferring a drug to a silica nanoparticle having an open pore having a size increasing from the center of the particle to a surface direction and an object using the same. With this, a high-dose drug can be carried on the nanoparticles and the release rate of the drug can be controlled (abstract). A drug-containing sustained-release drug delivery composition comprising silica nanoparticles having open pores having a size increasing from the center of a particle to a surface thereof and a drug bound to the interior of the pores of the silica nanoparticles. The pores are arranged radially from the center of the particles (claim 1).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Koyakutty et al. is that Koyakutty et al. do not expressly teach radial pore. This deficiency in Koyakutty et al. is cured by the teachings of Yang et al. and Hong et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Koyakutty et al., as suggested by Yang et al. and Hong et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to have porous silica nanoparticle with 3d radial pore because porous silica nanoparticle with 3d radial pore is suitable nanocarrier for drug delivery. MPEP 2144.07. Under guidance from Yang et al. teaching porous silica nanoparticle with radially large pore structure for carrying large space steric hindrance of the molecule; Hong et al. teaching porous silica nanoparticle with radial pore for a high-dose drug and the release rate of the drug can be controlled; since it is advantage to do so, it is obvious for one of ordinary skill in the art to have porous silica nanoparticle with 3d radial pore and produce instant claimed inventio with reasonable expectation of cusses.
Regarding claim 3, since Yang et al. teaches a central radially large pore structure gradually increases from the inner to the outer, and Hone et al. teaches open pores having a size increasing from the center of a particle to a surface, the radial pore is three dimensions.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that Lee et al. does not teach delivery of antigen and excellent antioxidant and anti-inflammatory effects not useful for antigen delivery. All related arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. It is always advantage to have excellent antioxidant and anti-inflammatory effects to reduce mortality and tissue damage due to inflammatory diseases because potential inflammation can be avoided during antigen delivery. Thus, the 103 rejection is still proper.
Applicants argue about Lee teaching liposome which would cause variation of vaccine.
In response to this argument: this is not persuasive. As discussed in the above 103 rejection, there is only modification by introducing ceria nanoparticle, and there is no requirement of liposome. Thus, the 103 rejection is still proper.
Applicants argue that Yang et al. and Yang et al. doe not teach porous particle for vaccine.
In response to this argument: this is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the above 103 rejection, Yang et al. and Yang et al. are only relied for teaching 3d radial pore, and the 103 rejection is still proper.
Applicants argued about specific tolerogenic DC phenotype, Treg expansion or antigen-specific tolerance observed in the specification.
In response to this argument: this is not persuasive, In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., specific tolerogenic DC phenotype, Treg expansion or antigen-specific tolerance) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613