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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2,4,6,9,13-15 and 17-21 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The new range recited in claim 1,”at least two ferromagnetic or ferrimagnetic iron oxide nanoparticles” is considered new matter. The lower data point of 2 was always associated with a numerical range, the broadest range was between 2 and 1000. Since applicants do not include the higher data point of 1,000 the recitation of two or more is considered new matter.
Furthermore, the new recitation in claim 1, “wherein the at least two ferromagnetic or ferrimagnetic iron oxide nanoparticles are maintained in the chain arrangement by a material of biological or non-biological origin so that the at least two ferromagnetic or ferrimagnetic iron oxide nanoparticles of the chain arrangement do not aggregate” is considered new matter. Preventing aggregation of the ferrimagnetic nanoparticle chains by a biological or non-biological origin is simply not described, therefore applicants do not have possession at the time the invention was filed for this limitation. Claims 2,4,6,9,13-15,17-21 incorporate the new matter by dependency.
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.
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) 1-2,4,6,9,13-15 and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nie et al. (WO 2005/102396) in view of Alphandery (US 2012/0302819).
Nie teaches multimodality nanostructures comprising a nanospecies including iron oxide nanoparticles and a second detectable moiety including an attached organic dye, either indirectly by non-covalent bonds or to a polymer layer disposed around the nanospecies (meeting claim 6); the nanostructures were detected using combinations of detection methods including optical and fluorescence (each considered to meet 1st excitation) as well as X-Ray CT, SPECT, PET and ultrasound (each considered to meet 2nd excitation). See entire disclosure, especially abstract, Fig 6-14, page 5 lines 16-29, page 8 last ¶ and claims, especially 1-2,6,11-13. Regarding claim 19, the size of the metal nanoparticle of Nie included sizes 1-100 nm, the data point of 100 nm is within the claimed range. See col 9 lines 59-63.
Nie while disclosing fluorescent coated iron oxide nanoparticles does not teach chains comprising the nanoparticles.
Alphandery teaches diagnosing/treatment of cancer using chains of 2-30 magnetosomes (iron oxide nanoparticles) extracted from bacteria (meeting claim 21), the chains were said not to form agglomerations and could be coated to enable targeting, improve cellular uptake, avoid recognition by macrophages and could contain fluorescent imaging agents for detection. See entire disclosure, especially abstract, [0020]-[0023],[0097] and claims. Alphandery further notes “Due to their arrangement in chains, the magnetosomes are not prone to aggregation and also possess a stable magnetic moment”. See [0020]. Due to the lack of aggregation Alphandery discovered the chains of magnetosomes leave the tumor rapidly while individual magnetosomes remain within the tumor 14 days post-injection. See [0246]. Regarding the new limitation that the nanoparticles are maintained in the chain arrangement by a material of biological or non-biological origin, since Alphandery teaches material membranes and coatings were applied to the nanoparticles and the chains did not agglomerate the limitation is considered met. The result in both the claims and Alphandery is the same, a material is used with the nanoparticles and the chains of the nanoparticles did not agglomerate. The chains of magnetosomes and the material coating them appear substantially similar to what was produced in applicants’ specification, therefore the examiner has good reason to believe the properties would be the same.
Since Nie teaches iron oxide nanoparticles and Alphandery teaches that iron nanoparticles could be arranged in chains produced from bacterium one of ordinary skill in the art would have a high expectation of success in forming chains with the nanoparticles of the primary reference. Reason to make such a modification would be to confer the advantageous properties noted for chain assembly including lack of aggregation leading to faster elimination from the body. Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the functional limitations or properties recited throughout the claims on an applied excitation causing dissociation or physio-chemical modification changing properties of the compound or environment, dissociation constant between the weak bonds, luminescence quenched and suppressed by iron oxide nanoparticle, coercivity of the iron oxide particle, magnetization properties, particle allowing energy and power transfer and luminescence properties are considered met since the particle produced and the types of energy applied is within the scope of the claims from the combination of Nie and Alphandery. The examiner must presume that any particle within the scope of the claims in which the same energy is applied will have the same properties and therefore meet the recited functional properties. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01 [R-3] II. Note the particle of Nie contains both iron oxide nanoparticle as well as the fluorescent compound to which radiation is applied and Alphandery provides the teaching of a chain made from ferrite nanoparticles, just as in the claimed subject matter. Any property measure or discovered is simply the natural result from the combined teachings.
Response to Arguments
Applicant’s arguments with respect to claim(s) 5/21/2025 have been considered but are moot because the new ground of rejection does not rely on the secondary reference Wang in the obviousness rejection anymore.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/ Primary Examiner, Art Unit 1618