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 .
Status of Claims
Claims 1, 4-9, 11-17, and 19-20 are pending. Claims 6-8 and 11-17 and 19-20 are withdrawn.
Priority
Instant application 17/970,448, filed 10/20/2022 claims priority as follows:
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Response to Amendment/Arguments
The amendment filed 04/27/2026 has been entered. Claims 1, 4-6, 9, 11-12, and 16-17 are amended. Claims 2-3, 10, and 18 are cancelled.
Claims 1-2, 4-5, and 9 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (Nanoscale Research Letters, vol. 4, no. 5, Jan. 2009, p. 400). In view of the amendments to independent claims 1 and 9 requiring toluidine blue O and requiring nanoparticles consisting of iron (II) oxide, applicant has overcome the rejection. Therefore, the rejection under section 102(a)(1) over Chen is withdrawn.
Claims 1-2, 4-5, and 9 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wen et al. (Advanced Materials Research, vols. 622–623, Dec. 2012, pp. 821–26). In view of the amendments to independent claims 1 and 9 requiring toluidine blue O and requiring nanoparticles consisting of iron (II) oxide, applicant has overcome the rejection. Therefore, the rejection under section 102(a)(1) over Chen is withdrawn.
Claims 1-5 and 9-10 were rejected under 35 U.S.C. 103 as being unpatentable over Rout et al. (Photodiagnosis and Photodynamic Therapy, vol. 21, Mar. 2018, pp. 190–200) in view of Li et al. (Nanoscale, vol. 11, no. 14, Apr. 2019, pp. 6905–15). In view of the amendments to independent claims 1 and 9 requiring a microemulsion consisting of toluidine blue O and nanoparticles consisting of iron (II) oxide, applicant has overcome the rejection. Therefore, the rejection under section 103 over Rout in view of Li is withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 112(b)
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.
Claim 4 is 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.
Claim 4 recites the microemulsion of claim 1, wherein the microemulsion is a magnetic-responsive photodynamic nanoplatform configured for targeted delivery of the plurality of superparamagnetic nanoparticles consisting of iron (II) oxide and the antimicrobial photosensitizer consisting of toluidine blue O. The structural elements of claim 4 (a microemulsion consisting of iron (II) oxide nanoparticles and toluidine blue) are the same as those recited in claim 1.
Accordingly, claim 4 may be interpreted as reciting the microemulsion of claim 1, wherein the microemulsion is “a magnetic-responsive photodynamic nanoplatform configured for targeted delivery of the plurality of SPIONs and the photosensitizer.”
Therefore, the difference between claim 1 and claim 4 appears to be that claim requires a microemulsion “configured for targeted delivery”, whereas claim 1 does not recite this limitation. However, it is unclear what elements (beyond those already recited in claim 1) should be present in order to produce an antimicrobial microemulsion of claim 1 which is “configured for targeted delivery”. With respect to functional limitations, MPEP 2173.05(g) states:
Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938))
In the instant case, regarding targeted delivery, the as-filed specification states (page 4, lines 1-7): “The plurality of SPIONs and the photosensitizer in the functional association therewith are irradiated during an application of a magnetic field to the [SPIONs]. The plurality of [SPIONs] and the photosensitizer are targeted to the oral area of interest via the magnetic field, thereby treating the oral disease in the subject.”
Accordingly, in view of the specification, it appears that the necessary elements required for “targeted delivery” are already present in claim 1, because claim 1 already recites a plurality of superparamagnetic iron (II) oxide nanoparticles in a functional association with toluidine blue O; AND the claim as amended closes the structure of the microemulsion due to the “consisting of” transitional phrase. Stated differently, the characteristics recited in claim 4 appear to be necessarily present in the composition of claim 1.
Therefore, it is unclear what additional elements, if any, are introduced into the composition by the recitation of “a magnetic-responsive photodynamic nanoplatform configured for targeted delivery” in the composition of claim 4. As a result, the metes and bounds of claim 4 are unclear. Accordingly, claim 4 is indefinite.
Appropriate clarification is requested. For example, applicant is invited to introduce into the claims, or identify in the specification, the additional elements which are considered to render the composition suitably “configured for targeted delivery”.
Response to Arguments
In the Remarks filed 04/27/2026, applicant traverses the rejection and argues that “claim 1 is directed to a microemulsion. Thus, dependent claim 4 limits the microemulsion of claim 1 to a magnetic-responsive photodynamic nanoplatform configured as claimed.”
Applicant’s arguments have been fully considered but are not found persuasive. Applicant’s response points to the claim preamble which recites “microemulsion” and concludes that claim 1 is directed to a microemulsion, whereas claim 4 limits the microemulsion of claim 4 to a magnetic-responsive photodynamic nanoplatform configured for targeted delivery. But the body of claim 1 recites the structural elements (superparamagnetic nanoparticles consisting of iron (II) oxide; toluidine blue O) which necessarily give the microemulsion of claim 1 the characteristics recited in claim 4.
Applicant has not addressed the Examiner’s argument above that it is unclear what additional elements, if any, are introduced into the composition by the recitation of “a magnetic-responsive photodynamic nanoplatform configured for targeted delivery” in the composition of claim 4. As a result, the metes and bounds of claim 4 are unclear.
Accordingly, the rejection is maintained for the reasons of record.
Claim Rejections - 35 USC § 112(d)
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 5 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.
Claim 5 depends from claim 1, and recites “The microemulsion of claim 1 formulated as a pharmaceutical composition.” Claim 1 recites a “consisting of” formulation that has only two components: a plurality of superparamagnetic nanoparticles consisting of iron (II) oxide; and toluidine blue O. But claim 5 incorporates the closed “consisting of” microemulsion of claim 1 inside a “pharmaceutical composition” which, as argued by Applicant in the Remarks 04/27/2026 “implies a formulation that includes an active ingredient combined with a carrier, excipient, or diluent, that is the term per se is understood in the art to mean more than just the pure active compound”.
If there are unrecited “implied” carriers, excipients, and/or diluents in the composition of claim 5, then the scope of claim 1 is not further limited, but instead broadened by reciting “the microemulsion of claim 1 formulated as a pharmaceutical composition”. Accordingly, claim 5 fails to further limit claim 1.
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.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112(a)
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, 4-5, and 9 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. This is a new matter rejection.
MPEP § 2163 states that, “[n]ew or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389,1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).” Further, the MPEP states, “[w]hile there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.”
Here, the amendments to independent claims 1 and 9 which require a microemulsion “consisting of” a plurality of superparamagnetic nanoparticles “consisting of” iron (II) oxide and an antimicrobial photosensitizer “consisting of” toluidine blue O are not expressly, implicitly or inherently disclosed in the original claims or specification.
There are two issues with the amended claims:
First, the application does not provide support for superparamagnetic nanoparticles consisting of iron (II) oxide. In the Remarks filed 04/27/2026, Applicant cited original claim 2 as providing support for the phrase “nanoparticles consisting of iron (II) oxide” (Remarks, page 7, para. 3). Please note that original claim 2 read: “the antimicrobial microemulsion of claim 1, wherein the superparamagnetic iron oxide nanoparticles are superparamagnetic iron (II) oxide nanoparticles”.
In their arguments (Remarks, page 13) applicant distinguished the amended claims from the prior art by stating “Applicant’s nanoparticles are not silicon dioxide coated”; and stated that “Applicant submits that while it is known that Fe3O4 comprises iron (II, III), the superparamagnetic nanoparticles in amended claims 1 and 9 can consist of only iron (II) oxide.” Accordingly, claims 1 and 9 are being interpreted as drawn to nanoparticles which are superparamagnetic nanoparticles consisting of iron (II) oxide which are uncoated and not Fe3O4.
But this is amendment to claims 1 and 9 is inconsistent with and unsupported by applicant’s disclosure. The only disclosure of nanoparticle synthesis can be found on page 16, lines 1-22 of the specification. The procedure states:
Briefly, 10 mL of deionized water was used to dissolve 0.2 g of polyglucose-sorbitol-carboxymethyl-ether (PSC). Then, 15 mL of water containing 0.06 g of FeCl₃ and 0.03 g of FeCl₂ was added. The mixture was cooled to 5 °C, and 1 g of 28% ammonium hydroxide was added and stirred for 2 min. Finally, the mixture was heated at 80 °C for 1 h and purified using a 100kDa membrane with five cycles.
The Examiner submits that the above procedure would result in a coated Fe3O4 nanoparticle. The coating is polyglucose sorbitol carboxymethylether (PSC). The procedure is comparable to one disclosed in CHEN et al. (Nanoscale, vol. 10, no. 16, Apr. 2018, pp. 7369–76). Chen discloses (SI page 1; page 9 of the attached PDF) the synthesis of Ferumoxytol, an FDA-approved superparamagnetic nanoparticle which is composed of an iron oxide core and a dextran (PSC) shell. See the procedure below for synthesizing “sample A”:
Polyglucose sorbitol carboxymethyl ether (PSC, modified dextran) solution (50 mg/mL) was mixed with iron salt (ferrous chloride and ferric chloride) solution for 10 minutes at 25 oC. Then ammonia was slowly dropped into under nitrogen bubbled with mild stir. External heat source from oil bath was started for the solution temperature rising. When the solution achieved 80 oC about 20 minutes later, the temperature and nitrogen atmosphere is maintained for 40 minutes. Then continue to heat the solution for another 2 hours with air bubbling. Final sample was dialyzed and filtration, then lyophilized under vacuum to gain solid powder for comprehensive characterization
See also the similar procedure for synthesizing “sample C” on page 1 of the supplementary material (page 9 of the attached PDF). See also the main article, page 7370, left side, stating: “After ammonia is added, the alkaline environment makes Fe3+/Fe2+ react with OH- to form Fe(OH)3/Fe(OH)2 and then Fe3O4; Fe3O4 continues to generate in the solution until saturation, and Fe3O4 nano crystals precipitate rapidly.” Therefore, Chen provides evidence that applicant’s disclosed procedure results in Fe3O4 nanoparticles coated with PSC, i.e. they are ferumoxytol-type nanoparticles.
Additionally, Applicant’s own specification indicates that the nanoparticles prepared by the procedure on page 16 are Fe3O4. See page 16, lines 19-20: “A Fe3O4 nanoparticle with an average diameter of 8.4 nm was chosen and treated as magnetic dipoles in the calculation.” See also page 6, line 20 (“a magnetite nanoparticle”). Magnetite is Fe3O4.
Second, the application does not provide support for a microemulsion consisting of only the nanoparticles and toluidine blue O (i.e., without any water or emulsifying agent). The specification states on page 23, lines 20-23 that “MagTBO microemulsions were synthesized using a high-ultrasonication method”; and that “TBO…and different mass fractions of Fe2O3 nanoparticles…were added to a mixture of distilled water, eucalyptus oil…polysorbate 20…and glycerol”. Note that this passage states that Fe2O3 nanoparticles (which are iron (III) oxide) were used; this is inconsistent with the earlier passages identified in the specification which point to the preparation of Fe3O4 nanoparticles which are iron (II,III) oxide.
The specification also states at page 19, lines 15-16 that “Untreated wells treated with glycerol, essential oil, and polysorbate 20 were used as controls.” The use of these ingredients as controls in an assay studying the effect of the MagTBO microemulsions on S. mutans indicates that they are ingredients in the microemulsions. Yet the claims exclude these ingredients from the microemulsion with the “consisting of” transitional phrase. Moreover, the claims 1 and 9 recite a “microemulsion” but consist of iron nanoparticles (a solid) and toluidine blue O (a solid). The preamble is inconsistent with the claimed subject matter.
In view of the foregoing, the specification does not provide written description support for uncoated iron oxide nanoparticles consisting of Fe (II) oxide and toluidine blue O.
A finding of written description support is not similar to obviousness analysis where one can assume applicant intended to recite the new limitations of instant claims 1 and 9 when they filed the application based solely on the passage on page 9 stating “Some embodiments of the invention may consist of or consist essentially of one or more elements, method step, and/or methods of the invention”. Applicants must actually have support for all limitations of the claims in the original disclosure. In this case, the microemulsions of claims 1 and 9 lack written description support in the original disclosure and therefore contain new matter.
Claims 4-5 depend from claim 1 and do not resolve the issues identified above. Therefore, claims 1, 4-5, and 9 are rejected.
Conclusion
Claims 1, 4-5, and 9 are rejected. Claims 6-8, 11-17, and 19-20 are withdrawn.
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 Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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