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 April 24, 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.
Applicant’s arguments with respect to the prior art rejections of the pending claim(s) have been considered but are moot because the new ground of rejection set forth below does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
The recitation “nanobomb” is not being given patentable weight because the rest of the claim describes a complete invention and “nanobomb” does not provide a distinct definition of any of the claimed invention’s limitations. Any composition comprising 1 or more first particles, comprised of one or more of iron oxide, gold, titanium oxide, carbon nanotubes, graphene oxide, polydopamine and poly(N-phenylglycine), and a number of second particles greater than the number of first particles, the second particles comprised of one or more of polystyrene, poly(lactic-co-glycolic acid), titanium dioxide, silicon, silicon oxide and liposomes positioned less than 1 µm from a majority of the first particle(s) and linked to the first particles via a charged polymer or lipid, one or more targeting ligands from the Markush group or claim 1 or a functional group to induce bioconjugation, complexation, physisorption or chemical connection fall within the scope of the claims. Claim 2 requires the first particle be adapted to vapor bubble generation that would propel a second particle to alter a biological barrier (emphasis added) but does not require vapor bubble generation to take place, any particles to be propelled and/or for a biological barrier to be altered.
Claim Rejections - 35 USC § 112 – Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Lines 5 – 6 of amended claim 1 require m to be greater than n so claim 3 fails to further limit. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 – 4, 8, 21, 22, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al. (US 2013/0023714).
Johnston et al. discloses nanoclusters or nanoroses comprised of two more closely spaced nanoparticles each comprising one or more metals, metal oxides, inorganic substances or a combination thereof in combination with one or more stabilizers in contact with the nanoparticles to form the nanocluster (whole document, e.g., abstract). This results in the various nanoparticles being linked to one another at least through chemical connection and results in the nanoparticles being in contact and linked to one another. Given the overall size of the nanoclusters is preferred to be less than 300 nm (¶ [0006]), the various nanoparticles are less than 1 µm from one another. The primary metal or metal oxide particles can be coated with a noble metal (e.g., ¶ [0091]), with iron, gold or silicon oxides exemplified for the primary metal or metal oxide particles and noble metal such as gold uses for the surface coating (¶ [0093]). Iron oxide particles with a thin gold shell are discussed such as at ¶ [0165]. The stabilizers can be polymers (e.g., ¶ [0093]) and can also comprise biodegradable polymers (¶ [0085]). Different types of primary nanomaterials can be clustered together while drug encapsulation inside the nanoclusters with controlled release can be triggered by polymer degradation in tumor microenvironment, enzyme sensitive polymers, or by an external stimulus such as NIR light or magnetic fields (¶ [0104]). To bring about the release of materials in a biodegrable nanocluster include magnetic fields, ultrasound techniques, laser or high intensity optical heating, magnetic, optical disruption or combinations thereof (¶ [0095]).
There are no examples with nanoclusters comprising different type of primary materials to meet the limitation of the first and second particles being compositionally distinct from one another.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate different types of primary nanomaterials in the nanoclusters or nanoroses disclosed by Johnston et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because various materials and coatings are taught as suitable for the primary nanomaterials connected to one another via the stabilizers and the clustering of different is disclosed. The use of different materials, e.g., those made from iron oxide alone, iron oxide with a gold coating and/or gold nanoparticles will have different properties as would be known to one of ordinary skill in the art. The different primary particles could have different mechanisms or thresholds, such as heating and/or to bring about the release of materials such as drugs from the nanocluster that would result in a multi-modal nanocluster. The number of each type of particle present in the nanocluster would be routinely optimized based on the desired characteristics such as amount of heat, degradation or release that each primary nanomaterial could provide. There is no evidence of record as to the criticality of the claimed number of first and second particles. There is no evidence of record that the clusters that these materials are not capable of generating a vapor bubble and the materials and disclosed techniques to bring about release from the nanoclusters are those that are recited in the instant claims.
Claim(s) 1 – 4, 8, 21 – 23, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al. as applied to claims 1 – 4, 8, 21, 22, 25 and 26 above, and further in view of Wang et al. (Adv Mater, 2013).
Johnston et al. is discussed above.
The presence of polystyrene particles is not disclosed.
Wang et al. discloses Janus nanocomposites that comprise a polystyrene core having folic acid, which reads on a targeting moiety, covered with a partial shell of silica having embedded iron oxide nanoparticles and doxorubicin, an anti-tumor agent, attached to the shell via a pH sensitive hydrazone bond (p 3485, col 2, ¶¶ 3 and 4 and Figure 1). The pH sensitive bond to the drug will limit the side effects of systemic circulation of free doxorubicin while the presence of iron oxide nanoparticles allows for noninvasive imaging, magnetic targeting and generation of magnetically-induced hyperthermia to sensitize tumor cells to cytotoxic drugs (¶ bridging cols 1 and 2 on p 3486).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate polystyrene particles into the nanoclusters or nanoroses of Johnston et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because such particles could form part of the nanoclusters that can be heated for hyperthermia and to release the Janus nanocomposite from the nanocluster. The material that brings about the release of active agents from the nanoclusters need not be the same for the multiple nanoparticles present in the nanocluster or nanorose or comprise a different drug or targeting agent than other elements to provide even more functionality to the materials of Johnston et al.
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 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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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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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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