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 .
Priority
This application, filed 20 November, 2024, claims foreign benefit of application TW113120724, filed 5 June, 2024.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 February, 2025 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 9 January, 2025, in the matter of Application N° 18/954,506. Said documents have been entered on the record.
No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot.
Thus, Claims 1-14 represent all claims currently under consideration.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 1 and 4-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a “use” of a compound rather than to a process, machine, manufacture, or composition of matter. A statutory method claim should positively recite acts or steps performed rather than merely recite a use of a compound.
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.
Claims 1, 4-9 and 13 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.
Regarding Claims 1 and 4-9, the recitation “use of indocyanine green for resisting or sterilizing a bacterium” merely states an intended use without positively reciting the acts that define the metes and bounds of the claimed subject matter. One of ordinary skill in the art would not be reasonably apprised of the scope of the claim.
Regarding Claim 13, the claim recites “wherein the subject or cell does not treated with an antibiotic.” The phrase “does not treated” is grammatically incomplete and renders the scope of the limitation unclear. It appears that Applicant may have intended to recite, for example, that the subject or cell “is not treated with an antibiotic”.
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 and 4-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the use of indocyanine green (ICG) in combination with near-infrared irradiation against the exemplified Mycoplasma, does not reasonably provide enablement for the full scope of the claimed use. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claim 1 broadly encompasses the use of ICG for resisting or sterilizing any Gram-negative bacterium and does not require irradiation of the ICG or bacterium. The working examples, however, demonstrate antibacterial or bactericidal activity of Mycoplasma using 50 μg/mL ICG in combination with irradiation at 780 nm (instant Specification, Pg 10, Examples 2-3.) The specification does not provide a working example demonstrating that ICG, absent irradiation, produces the claimed antibacterial or bactericidal effect.
Considering the factors set forth in In re Wands, the claims are broad relative to the scope of enablement demonstrated; the working examples are limited to Mycoplasma treated with ICG and near-infrared irradiation; and the specification provides insufficient guidance, or examples from which a skilled artisan could reasonably predict antibacterial or bactericidal efficacy of ICG without irradiation throughout the claimed scope. Accordingly, determining whether, and under what conditions, unirradiated ICG would resist or sterilize the encompassed bacteria would require experimentation beyond that reasonably supported by the disclosure. The breadth of the claims, limited scope of the working examples, lack of guidance concerning the unirradiated embodiments, and resulting unpredictability would require undue experimentation.
Claims 4-9 further limit the Gram-negative bacterium by cell-wall status and progressively narrower taxonomic classifications, culminating in Mycoplasma. Although, these limitations reduce the breadth of bacterial species encompassed, they do not require near-infrared irradiation and therefore continue to encompass the unirradiated embodiments for which the specification does not demonstrate or sufficiently teach antibacterial or bactericidal efficacy.
Claims 10-14 add limitations concerning administration of an effective amount of ICG, concentration, OATP1B3-assisted cellular uptake, absence of antibiotic treatment, or administration of an antibiotic. These limitations likewise do not require near-infrared irradiation and therefore do not remedy the enablement deficiency inherited from Claim 1. In particular, the disclosed OATP1B3 experiments demonstrate increased uptake and antibacterial/bactericidal efficacy in the context of ICG with near-infrared irradiation, rather than establishing efficacy of the additionally limited embodiments in the absence of irradiation.
For purposes of Examination under 35 U.S.C. 102 and 103, and notwithstanding the indefiniteness as noted above, the recited “use of indocyanine green for resisting or sterilizing a bacterium” is interpreted, to the extent reasonably possible, as encompassing a use, treatment, method, or composition comprising indocyanine green that resists or sterilizes the recited bacterium. The claims do not require ICG to be used alone, to be the sole or primary active agent responsible for the antibacterial or bactericidal effect, or to perform any particular function or mechanism of action. Further, no near-infrared irradiation or other unrecited treatment condition is read into claims that do not expressly require such a limitation.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lei et al. (CN 118873652 A, published 1 November, 2024), hereinafter Lei.
Lei teaches an antibacterial nanomaterial comprising indocyanine green having a strong killing effect against on Gram-negative bacteria, including Escherichia coli (‘652 Description Translation, Pg 2, §Summary of Invention and Pg 4, Performance Test 4 and Fig. 4 C/D description).
As such, Lei anticipates Claim 1.
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.
Claims 2-3, 10-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lei et al. (CN 118873652 A, published 1 November, 2024), hereinafter Lei.
The teachings of Lei are set forth in the above 35 U.S.C. 102 Rejection and are incorporated herein. Lei teaches an antibacterial nanomaterial comprising indocyanine green having a strong killing effect against on Gram-negative bacteria.
Regarding Claim 2, Lei further teaches that its ICG-containing nanomaterial (ICG@Fe-Que) exhibits strong photodynamic properties under irradiation with an 808 nm laser and teaches photodynamic antibacterial therapy as employing a photosensitizer in combination with light of a corresponding wavelength to kill microorganisms (‘652 Description Translation, Pg 1, §Background Art and Pg 4 Performance Test 3 and Fig. 3 description). Although Lei does not expressly state that the Gram-negative bactericidal test described in Performance Test 4 was conducted under near-infrared irradiation, it would have been prima facie obvious to one of ordinary skill in the art at the time of invention to irradiate Lei’s ICG-containing antibacterial nanomaterial with the expressly disclosed 808 nm laser when employing the material for its disclosed antibacterial purpose, because Lei teaches both the photodynamic antibacterial mechanism and strong photodynamic activity of the same nanomaterial under such irradiation, with a reasonable expectation of obtaining an antibacterial effect.
Regarding Claim 3, Lei teaches irradiation of the ICG-containing nanomaterial with an 808 nm laser (‘652 Description Translation, Pg 4, Performance Test 3). The disclosed wavelength of 808 nm falls within the claimed range of about 700nm to about 1400 nm. Accordingly, Lei renders obvious the additional limitation of Claim 3 for the reasons discussed with respect to Claim 2.
Regarding Claim 10, Lei teaches an ICG-containing nanomaterial having antibacterial and wound-repair promoting properties, including in vivo testing demonstrating promotion of wound healing (‘652 Description Translation, Pg 2, §Summary of Invention and Pg 4, Performance Test 5). Although Lei does not expressly recite administering an “effective amount” of ICG to a subject in need thereof, it would have been obvious to one of ordinary skill in the art to administer an amount of Lei’s ICG-containing antibacterial nanomaterial effective to provide its disclosed antibacterial and wound-treatment effect to a subject having a bacterial wound infection, because Lei expressly provides the nanomaterial for antibacterial treatment and promotion of wound repair. A person of ordinary skill would have had a reasonable expectation of success in doing so in view of Lei’s demonstrated antibacterial activity and in vivo wound-healing results.
Regarding Claim 11, Lei teaches antibacterial testing of ICG@Fe-Que nanomaterial at 50 μg/mL and further determines that the ICG drug loading of the ICG@Fe-Que particle is 24% (‘652 Description Translation, Pg 4, Performance Test 4 and 6, and Fig. 4 description). Thus, the disclosed 50 μg/mL concentration of ICG@Fe-Que containing 24% ICG corresponds to an ICG concentration of approximately 12 μg/mL, which falls within the claimed range of 5-100 μg/mL. It therefore would have been prima facie obvious to employ an effective amount within the claimed range when administering Lei’s antibacterial ICG-containing nanomaterial as discussed with respect to Claim 10.
Regarding Claim 13, Lei teaches that traditional antibiotic treatment is associated with increasing bacterial resistance and identifies photodynamic, chemodynamic, and photothermal antibacterial therapies as mechanisms for killing bacteria other than antibiotics and without occurrence of bacterial resistance (‘652 Description Translation, Pg 1, §Background Art). Lei’s disclosed ICG@Fe-Que antibacterial nanomaterial contains ICG, ferrous chloride, and quercetin and is demonstrated to have antibacterial activity without an antibiotic being identified as a component of the treatment. It would have been prima facie obvious to one of ordinary skill in the art to employ Lei’s disclosed antibacterial treatment without administering an antibiotic, consistent with Lei’s express teaching of these therapies as non-antibiotic approaches to bacterial killing and its objective of providing an alternative to traditional antibiotic treatment, with a reasonable expectation of obtaining the demonstrated antibacterial effect.
Claims 4-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lei (CN 118873652 A, published 1 November, 2024) as applied to Claims 1-3, 10-11 and 13 above, and further in view of Danielli et al. (WO 2020/261199 A1), hereinafter Danielli.
The teachings of Lei are set forth in the above 35 U.S.C. 102 and 103 Rejections and are incorporated herein. Lei teaches an ICG-containing nanomaterial having a strong killing effect against Gram-negative bacteria.
Lei, however, does not expressly teach wherein the Gram-negative bacterium is free of a cell wall or is a Mycoplasmota, Mollicutus, Mycoplasmatales, Mycoplasmataceae, or Mycoplasma, as recited in Claims 4-9.
Danielli teaches compositions comprising a sensitizer for treatment of bacterial infections and expressly identifies indocyanine green among the disclosed sensitizers (‘199, Pg 5, Line 3). Danielli further teaches that the bacterial infection is preferably caused by Gram-negative bacteria (‘199, Pg 5, Line 23) and expressly includes Mycoplasma among the Gram-negative bacteria contemplated for treatment (‘199, Pg 7, Line 7).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to employ Lei’s ICG-containing antibacterial material for resisting or sterilizing Mycoplasma, because Danielli identifies Mycoplasma as a Gram-negative bacterial target for sensitizer-based treatment, thereby providing a reason to select Mycoplasma as a Gram-negative bacterium to be treated with Lei’s ICG-containing antibacterial material, with a reasonable expectation of obtaining an antibacterial effect.
Regarding Claim 4, Mycoplasma inherently lacks a cell wall, as evidenced, for example, by the NIH/NLM MeSH description of Mycoplasma as a genus of Gram-negative bacteria whose cells lack a true cell wall. Thus, use of Lei’s antibacterial material against Mycoplasma as suggested by Danielli necessarily satisfies the additional limitation.
Regarding Claims 5-9, Mycoplasma is classified within Mycoplasmota, class Mollicutus, order Mycoplasmatales, family Mycoplasmataceae, genus Mycoplasma. Accordingly, selection of Mycoplasma as suggested by Danielli necessarily satisfies the progressively narrowing taxonomic limitations recited in Claims 5-9.
Regarding Claim 14, Lei teaches the subject matter of Claim 10 as discussed above, but does not expressly teach further administering an antibiotic to the subject or cell. Danielli teaches that its composition may be administered in association or combination with other molecules, in particular with at least one antibiotic (‘199, Pg 7, Line 10). It would have been prima facie obvious to one of ordinary skill in the art to further administer an antibiotic with Lei’s ICG-containing antibacterial treatment because Danielli expressly teaches combination of sensitizer-based antibacterial treatment with an antibiotic, thereby providing an additional antibacterial treatment modality with a reasonable expectation of obtaining an antibacterial effect.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lei (CN 118873652 A, published 1 November, 2024), as applied to Claims 1 and 10 above, and further in view of Kagawa et al. (HEPATOLOGY, Vol. 65, No. 3, 2017, PP 1065-1068), hereinafter Kagawa.
The teachings of Lei are set forth in the above rejections and are incorporated herein. Lei teaches an antibacterial nanomaterial comprising indocyanine green (ICG) having a strong killing effect against on Gram-negative bacteria, but does not expressly teach that uptake of ICG is mediated by organic anion transporting polypeptide 1B3 (OATP1B3).
Kagawa teaches that OATP1B3 is involved in hepatic uptake of ICG. In particular, Kagawa reports that OATP1B3 can transport ICG in vitro and that hepatocellular carcinoma tissues exhibiting ICG accumulation showed stronger OATP1B3 expression than tissues without ICG accumulation. Kagawa concludes that OATP1B3 is the major hepatic transporter for ICG uptake and that OATP1B3 deficiency profoundly impairs ICG clearance (Kagawa, Pg 1067-1068, §Discussion).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of invention, in view of Kagawa, that the ICG uptake taught by Lei would include uptake mediated by OATP1B3, because OATP1B3 was known in the art to be a major hepatic transporter responsible for ICG uptake.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
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