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 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 4 and 7 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’s unclear what it means for the claimed iron oxide to be “derived” from complexes of iron and one or more compounds. A chemical derivative is a compound formed from a parent compound by replacing one or more atoms or functional groups with others. It’s unclear how far removed the iron oxide can be from the complexes or iron and one or more compounds and still be considered iron oxide. Further regarding claim 4, in the recitation “amine-based compound,” it’s unclear if this means compounds that comprise an amine, if this includes compounds that comprise amine derivatives, and if this includes compounds that are based on amine functionality but do not comprise an amine or amine derivative in their structure. Further regarding claim 7, it’s unclear what it means for the weight ratio to be based on iron oxide, if this means that the weight ratio being claimed is wherein iron oxide is “1” in the ratio, or if “MXn” is “1” in the ratio 1:005 to 0.10.
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.
Claims 1 and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2008189967 (“Fujifilm”) in view of 20140194733 to Goforth. Fujifilm teaches magnetic nanoparticles cores comprising an iron oxide such as a-Fe2O3, y Fe2O3, FeO, or Fe3O4, over which is a shell which is comprised of a platinum salt, such as PtCl4 and a polypropylene oxide coating adsorbed onto the nanoparticles, the average diameter of the nanoparticles being between 5 nm and 20 nm; and the nanoparticles being used at a frequency of 150 kHz (abstract; paragraphs 17, 31, 34-35, and 59; claims 1, 2 and 14). This is iron oxide magnetic particles containing iron oxide and MXₙ (claim 1), wherein at least a portion of the surface of the iron oxide magnetic particles is additionally coated with a hydrophilic polymer to form a complex (claim 3), the iron oxide is derived from iron and one or more compounds selected from an amine-based compound) (claim 4); the iron oxide is a-Fe2O3, y Fe2O3, FeO, or Fe3O4 (claim 5), the polymer is polypropylene oxide (claim 6), the particles have a diameter of 0.1 nm to 1,000 nm (claim 8), and the iron oxide magnetic particles are used at a frequency of 1 kHz to 1 MHz (claim 9).
Fujifilm fails to teach a salt MXn according to the claims. Fujifilm further fails to teach “wherein the iron oxide magnetic particles contain MXn at a weight ratio of 1:0.005 to 0.08 based on iron oxide.”
Goforth teaches dextran-coated bismuth nanoparticles used as X-Ray contrast agents such as BiI3, BiCl3, and BiBr3 (corresponding to present MXₙ, wherein M is Bi; X is I, Cl, or Br; and n is 3. The radiopaque bismuth particles include an elemental bismuth core and an outer coating comprising one or more coating agents such as polyacrylic acid (a hydrophilic polymer) (abstract; paragraph 6). The particle diameter may be 50-75 nm (wherein the particles have a diameter of 0.1 nm to 1,000 nm) (paragraph 67).
It would have obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the bismuth salts of Goforth as the contrast agent on the iron oxide surface of Fujifilm. The motivation for this would be that Fujifilm desires incorporation of an X-ray contrast agent salt onto its iron oxide particle, and BiI3, BiCl3, and BiBr3 are agents which are taught for application onto particle surfaces for use as X-ray contrast agents . In using BiI3, BiCl3, and BiBr3 in the contrast agent of Fujifilm, the iron oxide particles may be used as a contrast agent, as desired by Fujifilm. The resulting composition is iron oxide magnetic particles containing iron oxide and MXₙ where M is Bi (a transition metal containing electrons in a 7d orbital on the periodic table) (claim 1), wherein at least a portion of the surface of the iron oxide magnetic particles is additionally coated with a hydrophilic polymer to form a complex (claim 3), the iron oxide is derived from iron and one or more compounds selected from an amine-based compound) (claim 4); the iron oxide is a-Fe2O3, y Fe2O3, FeO, or Fe3O4 (claim 5), the polymer is polypropylene oxide (claim 6), the particles have a diameter of 0.1 nm to 1,000 nm (claim 8), and the iron oxide magnetic particles are used at a frequency of 1 kHz to 1 MHz (claim 9). It would have been further obvious to optimize the amount of platinum salt on the surface of the iron oxide magnetic particles, and in this way, one would find the present weight ratio through routine experimentation with a reasonable expectation of success, as the amount of platinum salt is a result effective parameter in the use of the particles as imaging agents in MRI and X-ray contrast agents. “‘[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.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP § 2144.05, II.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2008-189967 A in view of 20140194733 to Goforth in further view of Kubik (Frontiers in Medicine, 2021). The relevant portions of Fujifilm are given above.
Fujifilm and Goforth fail to teach wherein M comprises a radioisotope.
Kubik teaches that isotopic iron oxide particles are useful for tracing biological processes and the location of the particles once administered to a patient(abstract; introduction).
It would have been obvious to one of ordinary skill in the art at the time the invention was made modify M to comprise a radioisotope. The motivation for this would have been to trace the path of the iron oxide nanoparticle after it enters the body to monitor when the agent reaches the portion of the body that needs imaging.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending U.S. Patent Application No. 18/270,118 in view of JP 2008-189967 A (“Fujifilm).” Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite the same composition as the present claims, except that in the present claims, M may be Tl, Pb, Bi, and Po, where as in the copending claims, M may be MXn may be Hf, Ta, W, Re, Os, Ir, Pt, Au and Hg. However,Fujifilm teaches iron oxide magnetic particles containing iron oxide and MXn, wherein MXn is PtCl4, and further teaches that the formulation may be used as an X-ray contrast agent. It would have been obvious to substitute the salt enumerated in the present claims with PtCl4, the motivation would be to produce an iron oxide magnetic particle whichi can be used as an x-ray contrast agent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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
December 27, 2025