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 the Claims
Claims 1-15 are pending (claim set as filed on 5/15/2024). Claims 10-15 are withdrawn after restriction/election requirement. Claims 1-9 are under examination.
Election/Restrictions
Claims 10-15 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of screening compounds for efficacy against bacterial persister cells, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/5/2026.
Priority
This application claims priority to provisional application no. 63/279,290 filed on 11/15/2021. As conditions for priority benefit have been met the effective filing date is 11/15/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/15/2024 is considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities: the claim recites that “the second antibiotic administered second”. However, this recitation is redundant as the second antibiotic is administered in the order that is introduced as otherwise it would be administered first, making it the first antibiotic administered. Appropriate correction is required to correct the claim language to “The method of claim 6, wherein the first and second antibiotics are administered sequentially.”
Claim Rejections - 35 USC § 112
Claims 1-9 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.
Claim 1 recites the limitation "the amphiphilic antibiotic" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. It is suggested that the applicant correct the term to “an amphiphilic antibiotic".
Claims 2-9 are rejected for depending on claim 1.
Claim 7 recites the phrase “wherein the step of administering the antibiotic capable of energy-independent diffusion and the second antibiotic requires active transport.” The claim is written in a manner that it is unclear if both the antibiotic capable of energy-independent diffusion and the second antibiotic require active transport or only the second requires active transport. If the claim is interpreted in the former manner, the claim is rendered indefinite as the antibiotic capable of energy-independent diffusion cannot also require active transport, as diffusion is considered to be a form of passive transport.
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)(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 and 4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ren (Patent No. US 9,370,189 B2 – date of patent 6/21/2016), as evidenced by Delcour (Delcour et al., “Outer membrane permeability and antibiotic resistance”, 2008 Nov 13, Biochimica et Biophysica Acta, 1794, pg. 808), and as further evidenced by Alexander (Alexander, “Tetracyclines for Clinical Microbiologists”, 2023 Sep 19, LinkedIn, https://www.linkedin.com/pulse/tetracyclines-clinical-microbiologists-jose, accessed 2026 May 27, pgs. 1-7).
Ren’s general disclosure relates to a method for controlling antibiotic tolerance of bacterial persister cells (see abstract).
Regarding claim 1, Ren teaches a method of administering an antibiotic to a population of bacterial cells, of which some are persister cells, to reduce the number of viable cells (see Ren col. 18, claim 1). As the applicant defines “waking up” the persister cells as killing the cells (see specification [0010]), which is also reducing their viability, this reads on the “waking up” limitation. As evidenced by Delcour, antibiotics are inherently capable of energy-independent diffusion and do not require active transport to penetrate a membrane of a bacterial cell (see Delcour abstract).
Regarding claim 2, Ren anticipates adding an amphiphilic antibiotic tetracycline to the persister cells (see Ren col. 18, claim 1). As evidenced by Alexander, tetracyclines are a class of antibiotics that are naturally amphipathic, otherwise known as amphiphilic (see Alexander pg. 7, ¶ 1).
Regarding claim 4, Ren anticipates adding an alginate lyase nutrient to the persister cell population (see col. 18, claim 3).
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Santa Maria (WO/2021/011398 – date of publication 1/21/2021), as evidenced by Delcour (Delcour et al., “Outer membrane permeability and antibiotic resistance”, 2008 Nov 13, Biochimica et Biophysica Acta, 1794, pg. 808), and as further evidenced by MedxDrg (MedxDrg, “Exploring the Amphoteric Nature: Are Fluoroquinolones Hydrophilic?”, 2025 Nov 24, MedxDrg, https://medxdrg.com/exploring-the-amphoteric-nature-are-fluoroquinolones-hydrophilic , accessed 2026 Jun 3).
Santa Maria’s general disclosure relates to treating bacterial persister cell infections with nanoparticles (see abstract).
Regarding claim 1, Santa Maria teaches a method of administering nanoparticles and an antibiotic to antibiotic-resistant persister bacteria (see Santa Maria[0020-0021]) wherein the persister cells are eradicated after the antibiotic is administered (see Santa Maria[0022]). As the applicant defines “waking up” the persister cells as killing the cells (see specification [0010]), which is also eradicating them, this reads on the “waking up” limitation. As evidenced by Delcour, antibiotics are inherently capable of energy-independent diffusion and do not require active transport to penetrate a membrane of a bacterial cell (see Delcour abstract).
Regarding claim 2, Santa Maria anticipates adding an amphiphilic antibiotic fluoroquinolone to the composition administered to the persister cells (see Santa Maria[0019-0021]). As evidenced by MedxDrg, fluoroquinolones are a class of antibiotics that are both hydrophobic and lipophilic, which is what defines an amphiphilic compound (see MedxDrg pg. 1, ¶ 1).
Regarding claim 4, Santa Maria anticipates adding a metal nanoparticle nutrient in the composition administered to the persister cells (see [0015] and [0020-0021]).
Regarding claim 5, Santa Maria anticipates an assay to assess the treatment of an infection since the claim does not require in vivo. The assay tests for the fraction of persister cells remaining in a culture solution after being treated with the antibiotic ofloxacin, an amphiphilic fluoroquinolone, and the subsequent removal of the antibiotic from the solution (see [00154]). Under broadest reasonable interpretation, this reads on the removal of extracellular antibiotics from a population of bacterial cells.
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.
Claims 3 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Santa Maria (WO/2021/011398 – date of publication 1/21/2021), as evidenced by Delcour (Delcour et al., “Outer membrane permeability and antibiotic resistance”, 2008 Nov 13, Biochimica et Biophysica Acta, 1794, pg. 808), and as further evidenced MedxDrg (MedxDrg, “Exploring the Amphoteric Nature: Are Fluoroquinolones Hydrophilic?”, 2025 Nov 24, MedxDrg, https://medxdrg.com/exploring-the-amphoteric-nature-are-fluoroquinolones-hydrophilic , accessed 2026 Jun 3).Santa Maria’s general disclosure has been set forth.
Regarding claim 3, Santa Maria teaches additional antibiotics minocycline, eravacycline, and rifampicin (see [00115]). Rifampicin is a class of drug within rifamycin and so reads on the claim.
Regarding claim 6, Santa Maria teaches administering a second antibiotic rifampicin that is able to kill active bacteria (see [0059]), as it is disclosed that one or more antibiotics can be used in the method (see [00115]).
Regarding claim 7, Santa Maria teaches that a second antibiotic can be used (see [00115]). Santa Maria also teaches that these nanoparticle-antibiotic compounds require active transport in the sense that their mechanism of action is dependent on the persister bacteria’s efflux pump active transport system, wherein the antibiotic inhibits this system (see [00209]). As referenced in the 112b rejection above, it is unclear whether the recited antibiotic capable of energy-independent diffusion also requires active transport and if this antibiotic refers to the second antibiotic either. The examiner interprets that a second antibiotic requiring active transport during the process reads on the claim.
Regarding claim 8, Santa Maria teaches the one or more therapeutic agents, such as antibiotics, can be administered at the same time (see [00127]).
Regarding claim 9, Santa Maria teaches the one or more therapeutic agents, such as antibiotics, can be administered sequentially (see [00127]).
Regarding claim 3, Santa Maria suggests the claimed antibiotics minocycline, eravacycline, and rifampicin but they are not immediately envisaged.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the antibiotics minocycline, eravacycline, and rifampicin as taught in Santa Maria. The ordinary artisan would be motivated to do so because Santa Maria suggests the addition of these antibiotics to the anti-bacteria composition (see [00115]) in addition to the nanoparticles to treat infections. Thus, it would be obvious to add the desired antibiotic to treat the targeted infection.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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