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 .
Claim Objections
Claims 8 and 13 are objected to because of the following informalities:
Claim 8 recites “…N,Nbis(2-hydroxyethyl)laurylamine”. The Examiner suggests adding a hyphen so that it has proper chemical nomenclature: “…N,N-bis(2-hydroxyethyl)laurylamine”.
Claim 13 recites “…therein,the micelle…”. The Examiner suggests adding a space after the comma in order to obviate the claim objection.
Appropriate correction is required.
Specification
The specification is objected to because the description and drawing sections use the following abbreviations without defining them: PTC, PTC-M and PC and PC-M and one of ordinary skill in the art at the time of the filing would not know what they specifically mean.
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 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.
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 1-7, 9-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Colloids and Surfaces B: Biointerfaces, Nov. 2020, volume 195, article 111276), in view of Zhu et al. (CN 107320738; published: 11/7/17; in IDS dated 3/19/25).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Wang is directed to the preparation of ROS-responsive core crosslinked polycarbonate micelles with thioketal linkage [Title].
With regards to instant claims 1, 5-7, 10, 12, Wang teaches a novel reactive oxygen species (ROS) responsive core crosslinked (CCL/TK) polycarbonate micelles conveniently by click reaction between amphiphilic diblock copolymer poly(ethylene glycol)-poly(5-methyl-5-propargylxycar-bonyl-1,3-dioxane-2-one) (propargyl reads on the hydrophobic hydrocarbon group) (PEG-PMPC) with pendant alkynyl group and thioketal containing azide derivative bis (2-azidoethyl) 3, 3′- (propane-2, 2-diylbis (sulfanediyl)) dipropanoate (TK-N3) [abbreviated CCL/TK micelle throughout; Abstract]. Wang teaches wherein the CCL/TK micelles were loaded (i.e., a micelle having an active “therein”) with doxorubicin (DOX) [Abstract]. Wang teaches that the DOX-loaded CCL/TK micelles are 156.8, 191.9 or 241.4 nm depending on the DOX feed ratio [Table 1].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Wang does not teach wherein the micelle has a manganese oxide particle therein and wherein the manganese oxide particle is hydrophobically modified by, for example, an unsubstituted C1 to C30 alkyl group, has a particle diameter of 10 to 30 nm and made of, for example, Mn3O4, as required by instant claims 1-4. Wang does not teach wherein the manganese oxide nanoparticles in included in an amount of 5-10 parts by weight based on 100 parts by weight of the micelles, as required by instant claim 9. However, this deficiency is cured by Zhu.
Zhu is directed to Mn3O4-alpha-lactalbumin (A-LA) nanospheres and as described in the method of making hydrophobic Mn3O4 is reacted with hydrolyzed A-LA to obtain Mn3O4-LA composite particles and crosslinked with disulfide bonds. Zhu teaches that the surface of the Mn3O4 particles is hydrophobically modifying with oleic acid and the particle size is less than 10 nm. Zhu teaches that the mass ratio of A-LA to Mn3O-4 nanoparticles is 1:1 to about 5:1. Zhu teaches that when the nanospheres dissociate and release Mn2+ (nuclear magnetic imaging agent) and drug molecules under double stimulation of low pH and high concentration of GSH and can be used as a diagnostic and therapeutic agent. Zhu teaches that such drug molecules can be hydrophobic or hydrophilic (e.g., DOX). Zhu also teaches that the Mn3O4 nanoparticles are advantageous because they have good biocompatibility and are easy to degrade in the cells [see paragraphs above “Brief description of the drawings”].
With regards to the taught ranges and the claimed ranges, the Examiner directs attention to MPEP §2144.05(I): a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Wang and Zhu are both directed to DOX-loaded formulations. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the micelle composition of Wang by further incorporating the oleic acid-modified Mn3O4 nanoparticle (approaching 10 nm particle diameter) taught by Zhu to achieve the predictable result of obtaining a composition suitable for cancer treating. One of ordinary skill in the art would have been motivated to do so because Zhu teaches that such Mn3O4 nanoparticle is advantageous in that it provides a diagnostic agent to the DOX-containing composition and furthermore, that it has good biocompatibility and is easy to degrade in vivo.
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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Colloids and Surfaces B: Biointerfaces, Nov. 2020, volume 195, article 111276), in view of Zhu et al. (CN 107320738; published: 11/7/17; in IDS dated 3/19/25) as applied to claims 1-7, 9-10 and 12 above, and further in view of Ulthaman et al. Biomaterials, Feb 2020, 119702; in IDS dated 3/19/25).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Wang and Zhu teach the limitations of instant claims 1-7, 9-10 and 12 (see rejection above for details).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Wang and Zhu do not teach wherein the hydrophobic portion of the micelle is has a manganese oxide particle therein and wherein the manganese oxide particle is derived from, for example, stearic acid, as required by instant claim 8. However, this deficiency is cured by Uthaman.
Uthaman is directed to photocleavable nanomicelles constructed by self-assembling of PEG-stearamine conjugates with a ROS-sensitive thioketal linker and co-loaded with DOX [Abstract].
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (PEG- poly(5-methyl-5-propargylxycar-bonyl-1,3-dioxane-2-one) micelles with PEG-stearamine micelles for the purpose of providing a micelle formulation suitable for DOX-loading) (See MPEP 2144.06-II).
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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
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).
Claims 1-10 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/577,404 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising manganese oxide (e.g., MnO) particles (10-30 nm diameter) having a hydrophobic substituent (e.g., a C1-C30 alkyl group) on the surface thereof and a micelle formed of a micelle-forming molecule in which a hydrophilic portion (e.g., PEG) and a hydrophobic portion (e.g., a C12-C22 alkyl group) are bound by a ROS cleavable linker (e.g., thioketal). It is noted that the ‘404 composition represents a species (with regards to how the manganese oxide particles are located/complexed with the micelle – “supported on cores of the micelles”) within the scope of the instantly claimed genus. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cor. 1993). Thus, the instant claims and the application claims are obvious variants.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Note
Claim 13 and its dependent claims are free of the prior art. Although the composition is found prima facie obvious, the step of administering said composition to a subject in need of treating an inflammatory disease.
Conclusion
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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