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 .
Amendments
Applicants amendments to the claims filed 8/13/2026 have been entered. Any objection\rejections from the previous office action filed 4/14/2026 not addressed below has been withdrawn.
Election/Restrictions
Newly submitted claim 11 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: this claim to a container featuring a composition containing the magnetic nanoparticle would have been included in group II in the restriction requirement filed 4/14/2026 had it been originally presented at the time of the office action.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 11 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 1-6 and 12-14 are 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. In particular the functional limitation recited in claim 1 on a “directed group for a neurogenerative disease protein bonded to at least part of the polymer chain” does not meet the written description requirement. The claimed functional properties are achieved from a specific compound, namely Florbetaben F18 is disclosed and is known as having the property of a group capable of bonding and thereby directing to a protein known to be related to neurogenerative disease. Applicants are completely silent with respect to what other directed groups may be used to target the enormous genus of proteins encompassed by neurodegenerative disease related proteins. Thus the specific compound with this property must be positively specified in order to place one of ordinary skill in the art in possession of the claimed dosage with the desired properties. While applicants have shown possession of florbetaben as having the claimed feature of being directed towards a protein involved in neurogenerative disease they have failed to show possession all the claimed compounds directed towards any neurodegenerative related disease protein as recited in the generic claims. Applicants have not described this genus in a manner that would allow one skilled in the art to immediately envisage the compounds contemplated for use.
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 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) 1-6 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhana, S. et al., " Near-Infrared-Absorbing Gold Nanopopcorns with Iron Oxide Cluster Core for Magnetically Amplified Photothermal and Photodynamic
Cancer Therapy " ACS Appl. Mater. Interfaces2015,7,11637−11647, in view of ZHANG, S. et al., "Thiol-PEG-carboxyl-stabilized Fe2O3/Au nanoparticles targeted to CD105: Synthesis, characterization and application in MR imaging of tumor angiogenesis". European Journal of Radiology, 83(2014) pp. 1190-1198, cited in view of Zeng et al., "A Novel Magnetic Nanoparticle for Early Detection of Amyloid Plaques in Alzheimer's Disease". Archives of Medical Research, 49(2018) pp.282-285, cited previosuly.
Bhana teaches NIR gold nanopopcorns with iron oxide core, the gold was present as nanoparticles seen in Fig 1 on the surface of the iron oxide and PEG (MW 5,000, meeting claim 3) was bound to the gold nanoparticles to stabilize the nanostructure. See entire disclosure, especially abstract, Fig 1 lft col. 2nd full ¶-rt col 1st ¶. Regarding claims 5,12 and 14, the hydrodynamic diameter of the nanostructure was 170 nm and the size of the gold nanoparticles was 2-5 nm. See page 11641 left col 1st full ¶ and page 11642 rt col 2nd full ¶. Regarding claim 13, the size of the iron oxide nanoparticle was 8 nm and the size of gold was 2-5 nm, the examiner calculated the ratio between the two overlaps the claimed range (for instance 5/8 is 0.625). Therefor, based on the described overlap above, the instant claims would have been obvious to one of ordinary skill in the art. MPEP § 2144.05
Bhana is silent with respect to proteins for treating/diagnosing neurodegenerative disorders.
Zhang is used for its teaching on iron oxide/gold hybrid particles produced by reducing Au3+ on the surface of iron oxide, the nanoparticle was stabilized with PEG via an Au-S bond, the PEG further covalently bond through an amide linkage to anti-CD-105 antibodies. See entire disclosure, especially abstract, page 1191 left col 3rd ¶-rt col page 1192 left col. 1st ¶. Thus Zhang is used primarily for its teaching that it was well known in the art before the time of the claimed invention that proteins could be attached to gold by thiolated PEG.
Zeng is used for its disclosure on Pittsburg compound B (PiB) to modify magnetic nanoparticles as a PET tracer for detecting amyloid plaques in Alzheimer’s disease (AD) (meeting claim 3). See entire disclosure, especially abstract and conclusion on page 285.
Since the references are generally related in their teachings of magnetic nanoparticles and Zhang teaches how to attach proteins to gold particles one of ordinary skill would have a very high expectation of success in binding PiB to the PEGylated surface of the nanopopcorn gold iron oxide of Bhana. Reason to make such a substitution would be to diagnose early AD with the iron oxide/gold hybrid particles of Bhana coupled to PiB. 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 claim 2, Zeng is silent with respect to percent protein bonded to the polymer chain. However, the preparation of polymer-protein conjugates for these metal nanoparticles having a certain percentage of protein bond to polymer is within the level of skill of one having ordinary skill in the art at the time of the invention. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971).
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection relies on a new primary reference Bhana above, which teaches the same iron oxide nanoparticle with gold particle supported on the surface.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 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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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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