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 .
Applicants' arguments, filed June 9, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – New Matter
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.
Claim 1 was 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. This new matter rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 9, 2026 and those set forth herein.
The range of “from 1% by mass to 9.6% by mass” for the gadolinium oxide content in the composite particles was previously rejected as new matter.
In response, Applicants have amended this range to be “9.6% by mass or less”, and cite to the Examples 1 and 2 that have 9.6% and 8.6% by mass respectively as support for the claim limitation and provide no additional arguments.
The claim amendments are insufficient to result in a claim that is fully supported by the disclosure as filed. The claimed range extends down to very little gadolinium oxide present in the composite particles but the two discreet values that are not close to zero for the specific particles that were prepared. One example coated the particles with methyl methacrylate and trimethylolpropane trimethacrylate (example 1) and the other with styrene, divinylbenzene and trimethylolpropane trimethacrylate (example 2) but that is nowhere near the scope of the polymer coating of claim 1. Given the two specific values and specific coating materials and the much larger breadth of the claim, the full breadth of claim 1 is not supported by the disclosure as originally filed and claim 1 still contains new matter.
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 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 was rejected under 35 U.S.C. 103 as being unpatentable over Masuda et al. (WO 2017/204209; all citations from US 2020/0319171, the PGPub of the national stage entry) in view of Wang et al. (Nanotechnology, 2016). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 9, 2026.
Applicants traverse this rejection on the grounds that Masuda does not recognize magnetic resonance imaging as an intended use for the described composite particles. Masuda discloses a high content of the inorganic nanoparticle of 80% by mass or more in ¶ [0039], which the Examiner has noted as containing the phrase “in one embodiment” as permitting other embodiments having lower gadolinium oxide content and also citing to ¶ [0139] as describing a lower limit of gadolinium oxide but the description of these two paragraphs must be considered in relation to each other. When ¶¶ [0039], [0040] and [0139] are considered, one of ordinary skill in the art would not be motivated to use less than 9.6% mass of gadolinium oxide as claimed. The particles in Masuda are intended for use in magnetic separation and detection with the phrase “detecting a specimen” at ¶ [0161] referring to a magnetic separation method.
These arguments are unpersuasive. As set forth previously, e.g. the top of p 4 of the Office Action mailed March 9, 2026, as long as the structure of the prior art is capable of being used as an imaging agent for MRI, then this limitation of the claim is met as the claims are drawn to a product and not a method of use and the exact context of use set forth by Masuda does not patentably distinguish the instant claims. The preferred range of 1 – 95% by mass inorganic content from ¶ [0139] and the range of 80% or more by mass inorganic particles in Masuda et al. are both non-limiting embodiments within the scope of the disclosed particles. The teachings of the secondary reference as to the effects of coating thickness, which necessarily alters the mass percent of inorganic nanoparticle material being coated, motivates one of ordinary skill in the art to optimize the coating thickness, which, as taught by Masuda et al., can vary widely and there is no evidence of record as to the criticality of the claimed range.
Regarding Wang, Applicants argue that this reference never discloses or even suggests a gadolinium oxide mass% in the particles but there is no technical basis for the conclusion of the Examiner that optimizing the tradeoff would inherently result in a gadolinium oxide content as claimed. The required rational underpinning for an obviousness rejection is not present and no logical basis for the conclusion that determining the balance of imaging performance and cell toxicity would inherently derive a gadolinium oxide content according to claim 1. This combination of references cannot disclose all the elements of claim 1 so the obviousness rejection cannot be supported.
These arguments are unpersuasive. The explicit, implicit and inherent teachings of the applied prior art and the knowledge of one of ordinary skill in the art must be taken into account when evaluating obviousness. Broader or overlapping ranges for the amount of the inorganic nanoparticle portion of the composite particles are disclosed by Masuda et al. and that the content and thickness of the polymer layer is appreciated by Masuda et al. at ¶ [0147] as long as the content falls within the described ranges. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. That the materials of Masuda can be used as imaging agents, rendering factors such as biocompatibility relevant for the particles of Masuda is taught by Wang et al. Wang et al. provides guidance as to factors to be considered when determining the optimal amount of coating content/thickness in the particles of Masuda and thicker coatings tending to improve biocompatibility due to decreased Gd3+ ion leakage (abstract). While there may not be an explicit teaching, suggestion or motivation to optimize within the ranges that are disclosed wherein thin coatings can result in decreased biocompatibility, one of ordinary skill in the art would have motivation to determine the optimal coating thickness for a use as in Wang et al. The presumption of the obviousness of ranges such as those that overlap can be rebutted by sufficient evidence of unexpected results arising from the claimed range, but no such evidence is of record and this rejection is maintained.
Conclusion
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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