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 1-20 are pending.
Priority
Instant application 17/970,448, filed 10/20/2022 claims priority as follows:
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Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5 and 9-10 in the reply filed on 10/05/2025 is acknowledged. Claims 6-8 and 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/05/2025.
Claim Interpretation
Claim 4 recites an antimicrobial composition of claim 1, wherein the antimicrobial microemulsion comprises a magnetic-responsive photodynamic nanoplatform configured for targeted delivery of the plurality of superparamagnetic iron oxide nanoparticles (“SPIONs”) and the photosensitizer. With respect to the phrase “magnetic-responsive photodynamic nanoplatform”, the as-filed specification states (page 10, lines 1-3):
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Therefore, the aforementioned phrase is being interpreted according to the above passage in the as-filed specification.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 5 recites a pharmaceutical composition comprising the antimicrobial microemulsion of claim 1. The composition of claim 5 does not set forth any additional structural elements and is therefore being interpreted as a substantial duplicate of claim 1.
Claim Rejections - 35 USC § 112
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 antimicrobial microemulsion of claim 1, wherein the antimicrobial microemulsion comprises a magnetic-responsive photodynamic nanoplatform configured for targeted delivery of the plurality of SPIONs and the photosensitizer. In view of the as-filed specification, the phrase “magnetic-responsive photodynamic nanoplatform” is interpreted as interchangeable with “antimicrobial microemulsion”. Accordingly, claim 4 may be interpreted as reciting the antimicrobial composition of claim 1, wherein the antimicrobial microemulsion comprises an antimicrobial microemulsion 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 SPIONs in a functional association with a photosensitizer. Stated differently, the functional characteristic recited in claim 4 appears 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”.
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 recites a pharmaceutical composition comprising the antimicrobial microemulsion of claim 1. The composition of claim 5 does not set forth any additional structural elements and is therefore being interpreted as a substantial duplicate of claim 1. 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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-5, and 9 are 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).
Chen discloses a microemulsion comprising a plurality of superparamagnetic iron oxide nanoparticles; and a photosensitizer in a functional association with the plurality of superparamagnetic iron oxide nanoparticles. In particular, Chen discloses Fe3O4 nanoparticles in association with the photosensitizer PHPP (page 401, right side, final para.): “Micelles were prepared by dissolving 0.90 g AOT and 1600 uL 1-butanol in 40 mL doubly distilled water by vigorous magnetic stirring. A solution of 60 uL PHPP (15 mmol L-1) in 1-butanol and 0.003 g Fe3O4/OA nanoparticles were added to above micellar system. After 30 min stirring, a new micellar system containing PHPP-Fe3O4/OA was formed.”
See also page 404, Fig. 3 which is a scheme the formation of a microemulsion comprising iron oxide nanoparticles in a functional association with a photosensitizer (PHPP):
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Please note that the preamble recitation “antimicrobial” in claim 1 is being interpreted according to MPEP 2111.02 (II), which states: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. See also MPEP 2112.02, which states: “[W]hen the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated.”
Accordingly, claim 1 is anticipated by Chen.
With respect to claim 2, Chen’s Fe3O4 nanoparticles contain iron (II) and are therefore being interpreted as “iron(II) oxide nanoparticles”.
With respect to claims 4-5, Chen’s composition meets the structural limitations required and is therefore considered to anticipate these claims.
With respect to claim 9, PHPP is an organic photosensitizer. Accordingly, Chen’s microemulsion comprising Fe3O4 nanoparticles and PHPP anticipates claim 9.
Claims 1-2, 4-5, and 9 are 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).
Wen discloses a microemulsion comprising a plurality of superparamagnetic iron oxide nanoparticles; and a photosensitizer in a functional association with the plurality of superparamagnetic iron oxide nanoparticles. In particular, Wen discloses magnetite (Fe3O4) nanoparticles in association with the photosensitizer Photosan (page 822, 3rd para.): “Micelles were prepared by dissolving 0.90 g DSS and 1.6 ml 1-butanol in 40 ml doubly distilled water by vigorous stirring at room temperature. A solution of 60 ul Photosan in 1-butanol and 0.003 g Fe3O4/OA nanoparticles were added to the above micellar system. After 30 min stirring, a new micellar system containing Photosan-Fe3O4/OA was formed.”
Please note that the preamble recitation “antimicrobial” in claim 1 is being interpreted according to MPEP 2111.02 (II), which states: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. See also MPEP 2112.02, which states: “[W]hen the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated.”
Accordingly, claim 1 is anticipated by Wen.
With respect to claim 2, Wen’s Fe3O4 nanoparticles contain iron (II) and are therefore being interpreted as “iron(II) oxide nanoparticles”.
With respect to claims 4 and 5, Wen’s microemulsion meets the structural limitations required and is therefore considered to anticipate these claims.
With respect to claim 9, PHPP is an organic photosensitizer. Accordingly, Wen’s microemulsion comprising Fe3O4 nanoparticles and PHPP anticipates claim 9.
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.
Claims 1-5 and 9-10 are 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).
Rout discloses an antimicrobial microemulsion comprising the photosensitizer toluidine blue O (“TBO”) for use in photodynamic therapy against biofilms (abstract and page 191, right side, “photosensitizer formulations”). Rout discloses that TBO encapsulated in microemulsion was more effective in killing biofilm bacteria than only TBO in water (abstract, “results”).
The difference between Rout and the instant claims is that Rout fails to disclose a plurality of superparamagnetic iron oxide nanoparticles in the antimicrobial microemulsion.
However, Li teaches that magnetic iron oxide nanoparticles in combination with magnetic fields damage the biofilm matrix and cause detachment (abstract and page 6909, Table 1). Li further teaches that: (page 6913, left side, first para):
“[T]he current challenge in treating biofilms is addressing the increased resistance to antimicrobial agents of the bacteria within the biofilm. Furthermore, the EPS matrix acts as a barrier and delays or retards completely the infiltration of many antimicrobial agents. Therefore, our new approach using the iron-oxide magnetic nanoparticles to treat biofilms has two advantages. Firstly, nanoparticles penetrate the biofilm matrix and play a role as “shield breakers” to damage it. Secondly, since our nanoparticles cause only biofilm dispersal instead of killing, the method can be used over the long term as the biofilm will likely not increase its resistance to nanoparticles as occurs with antibiotics currently. These advantages point to magnetic nanoparticles offering an important design component in removing the biofilm that forms on the surface of medical devices. For the next step, MNPs could be incorporated with antibiotics and used with a magnetic field to achieve a synergistic effect and eliminate biofilms.
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying at least KSR example rationales (A) and (G), it would have been obvious to combine the antimicrobial microemulsion comprising TBO taught by Rout with superparamagnetic iron oxide nanoparticles taught by Li to arrive at an antimicrobial microemulsion for killing biofilms. A person having ordinary skill would have reasonably predicted that the TBO photosensitizer could be used for photodynamic killing of biofilms in combination with the mechanical killing effect of the magnetic iron oxide nanoparticles taught by Li. Indeed, Li explicitly suggests combining the magnetic iron oxide nanoparticles with other therapeutics, such as antibiotics, to achieve a synergistic effect and eliminate biofilms.
Please also note that it has been held that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Accordingly, claims 1, 3, 9, and 10 are prima facie obvious over Rout in view of Li.
With respect to claim 2, Li teaches Fe3O4 nanoparticles, which contain iron (II) and are therefore being interpreted as “iron (II) oxide nanoparticles”. Accordingly, claim 2 is obvious over Rout in view of Li.
With respect to claims 4 and 5, the microemulsion composition taught by Li in view of Rout meets the structural limitations required and is therefore considered to read on these claims. Accordingly, claims 4 and 5 are obvious over Rout in view of Li.
Conclusion
Claims 1-5 and 9-10 are rejected. Claims 6-8 and 11-20 are withdrawn.
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 8:30 am - 5:30 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