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 8/17/2026 have been entered. Any objection\rejections from the previous office action filed 5/15/2026 not addressed below has been withdrawn.
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 1-19 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 claim 1 the examiner did not find support for the new limitation “a ratio of the nanoparticle core to the polymer of less than 0.5”. Claims 2-19 incorporate the new matter by dependency.
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 1-19 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. Applicants amendment necessitated this new rejection.
In particular the new limitation in claim 1 “a ratio of the nanoparticle core to the polymer of less than 0.5” is unclear to what the ratio is limiting. Is it the size of the particle or weight? Since it is unitless and the claim does not establish if the ratio is for the length or weight the metes and bounds of the limitation are unclear. Claims 2-19 incorporate the indefiniteness by dependency.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-17 and 19 is/are rejected under 35 U.S.C. 102a1 as being anticipated by McNealy et al. (2014/0093550 A1). This modified rejection was necessitated by amendment.
McNealy discloses magnetic metal core nanoparticles featuring a hydrophilic coating of PEG and/or cyclodextrin (reading on claims 3 and 17). See entire disclosure, especially abstract and claims 1-6. Regarding the new limitation on the ratio of core to the polymer, the size of the metal core of McNealy was 6.5 nm and the hydrodynamic diameter depending on the polymer solution used was 39.7, 89.6 and 68.7 nm, thus the length of the polymer in solution surrounding the particle is ~33, 83 and 62 nm. See [0117] and table 1. The examiner calculated the ratio between the length of the metal particle and the polymer to be ~0.2 and 0.1, within the claimed range. Regarding the intended use and properties of the agent, including ability to change size in the body of a subject depending on stimulus, how the agent is stored and administered, undergo hydrolysis, size change based on threshold density, threshold density compared to polymer core, since the coated magnetic nanoparticles of McNealy are within the scope of the claims it follows it will be capable of the same use and have the same properties. The subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. See MPEP 2106 [R-6] pages 2100-6 through 2100-8. “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.
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) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNealy et al. (2014/0093550 A1), as applied to claims 1-17 and 19 above.
McNealy is cited above. While the examiner believes McNealy anticipates the claimed ratio it also follows such a ratio would be obvious to one of ordinary skill considered the teachings within. McNealy teaches that the stabilizing molecule (PEG coating) MW and therefore length can be varied to provide the desired hydrodynamic diameter. See [0004]. Thus the preparation of coated metal particles having variable MW and length of polymer compared to the core metal particle 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).
Regarding claim 18, McNealy teaches particle size of 1-50 nm, which overlaps the clamed size of particle of about 10 nm. See claim 5. A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. Therefor, based on the described overlap above, the size of 10 nm would have been obvious to one of ordinary skill in the art. MPEP § 2144.05. With regard to the recitation that the particle is configured to change in size to about 8 nm upon exposure to body tissue, it follows that since selecting a particle size of 10 nm would be obvious and the particle is within the scope of the claims it will change size to about 8 nm within the body. The change in size during use is a natural result that would occur when the particle is exposed to body tissue as claimed.
Response to Arguments
Applicant's arguments filed 8/17/2026 have been fully considered but they are not persuasive. Applicants assert the amended claims distinguish from the McNealy reference as it does not mention the ratio between core and polymer.
For the reasons set forth above in the modified rejection, the examiner believes McNealy does teach a ratio between polymer and core within applicants claimed range.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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
