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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-17 as well as the species naftifine and S. aureus in the reply filed on 07/06/2026 is acknowledged. Because applicant did not distinctly and specifically point out errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 18-22 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/06/2026.
The examiner was unable to identify prior art that anticipated or rendered obvious the elected species of antibiotic, naftifine, therefore examination has been extended to the next species, auranofin.
Claims 1-17 are under current examination.
Allowable Subject Matter
Claims 3, 10, and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
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, 2, 4, 5-9, 12, and 14-17 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.
Applicant is referred to the Guidelines on Written Description published at FR 66(4) 1099-1111 (January 5, 2001) (also available at www.uspto.gov). The following passage is particularly relevant:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between structure and function, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within a genus, one must describe a sufficient number of species to reflect the variation within the genus. What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. In an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
For Example MPEP 2163 states, in part,
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.”).
The instant application claims antimicrobials entirely in terms of their function, specifically, claim 1 requires antimicrobials that sensitize bacteria to oxidant killing. Claim 2 requires inhibitors of staphyloxanthin biosynthesis and claim 4 requires inhibitors of redox enzymes. Claim 5 further narrows the scope of redox enzyme inhibitors to inhibitors of thioredoxin.
In the instant case, inhibitors of staphyloxanthin will be taken as exemplary. With respect to the genus embraced by the claims, the phrase “antimicrobial that is an inhibitor of staphyloxanthin” embraces a genus of compounds that has relatively recently been recognized, is an area of active research, and comprises compounds that vary widely in their structure, source, and in terms of previously recognized function (Elmesseri et al. Antibiotics 2022, 11(3), 298): Recognized substances that inhibit staphyloxanthin synthesis range from polymers like chitosan, to essential oils (i.e. long chain hydrocarbons), to flavonoids (i.e. complex aromatic ring structures). There does not appear to be an overarching structural core to the chemicals that might be capable of inhibiting staphyloxanthin synthesis. Moreover, the field appears to be an area of active research, with the possibility of discovering novel inhibitors in the future.
With respect to disclosure of a representative number of species, Applicant’s specification lists naftifine, ALS 4, and auranofin as example of substances falling within the broader scope of “sensitizing bacteria to oxidant killing. When assessing the number of species that would be sufficiently representative to meet the written description requirement under 35 USC 112(a), the level of skill of an artisan in the field of inhibition of staphyloxanthin synthesis as well as the level of knowledge in the prior art and the predictability of the prior art must be considered. The artisans of skill in the field of antimicrobial agents in general would be a collaborative team of physicians, and/or biologists possessing an advanced degree in biomedicine and/or a doctor of medicine degree, thus the level of skill is high. The level of unpredictability in the art of i antimicrobial agents, and particularly of inhibitors of staphyloxanthin synthesis inhibitors is high based on the absence of clear relationship between structure and function and the emerging nature of the field. Using information provided in the prior art, one of ordinary skill in the art would not be able to readily predict which of the antimicrobials known, or yet to be discovered, embraced by the claim language would possess the claimed property of inhibiting staphyloxanthin synthesis, as explained above, the field remains nascent and there is not clear structural motif allowing one of ordinary skill to predict structure based on function. Thus, although the level of ordinary skill in the art is high, the predictability and level of knowledge available in the prior art is very low. The bar for written description of the claimed genus of hydrophobically modified polymers that effectively blocks synthesis of staphyloxanthin is therefore high.
Regarding reduction to practice, Applicant has demonstrated experimentally that the claimed species naftifine effectively accomplishes the claimed functions of sensitizing bacteria to oxidant killing; however, in view of the foregoing, one could not a priori predict what other substances within the scope of the term “antimicrobial” would also possess the claimed property of sensitizing to bacterial killing simply based on e.g. a link between structure and function.
The functional language recited in claim 1 stating that the antimicrobial sensitizes bacteria to oxidant killing appears to be merely a wish or plan for obtaining the invention as claimed, consistent with the patent at issue in University of Rochester vs. G.D. Searle & Co. In view of the foregoing the claims are rejected under 35 USC 112(a) as failing to satisfy the written description requirement.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the written concerns outlined above.
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 13 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.
The transitional phrase “includes” in claim 13 renders the claim indefinite because it is unclear whether the recited range in ratio is limiting or simply exemplary. Additionally, the claim could be interpreted to embrace a range in ratio of hemoglobin to naftifine that is broader than the recited range; however, it is ambiguous whether this interpretation was intended. The examiner recommends amending claim 13 to recite “The nanoparticle of Claim 1, wherein the hemoglobin and naftifine are present at a molar ratio ranging from about 1:3 to about 1:300 hemoglobin:naftifine”.
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.
Claims 1, 4-9, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herrlinger et al. (J Rheumatol Suppl Jul-Aug;8:81-9 1982; abstract only) as evidenced by Vaskovic (Erythrocytes - Histology, Structure, Function, Life Cycle Kenhub; online; retrieved 09/18/2026) and as evidenced by Gaikwad et al. Apolipoproteins, Triglycerides and Cholesterol; online; available from 05/14/2020).
Herrlinger describes a study in which erythrocytes, which contain hemoglobin bound to O2 and have PUFA from their red blood cell membrane, were exposed to auranofin in vivo and in vitro, and when the auranofin which is a redox enzyme inhibitor, specifically for thioredoxin reductase, was administered the gold (auranofin) accumulates within the erythrocytes (i.e. the cell contains hemoglobin and auranofin in its core and PUFAs in its coating). With regard to claim 1, as the term “nanoparticle” is not formally defined in the specification, the examiner interprets red blood cells to fall within the scope of nanoparticle, which is used in the art to refer to particles having diameter in the nanometer to low micron range. Erythrocytes have a diameter of 7-8 microns in one dimension but also are donut shaped and therefore have a width that is much narrower (Vaskovic, online; page 3). Healthy red blood cells have a zeta potential measured at 23.39mV in one study (Gaikwad et al, online; abstract, page 3). As such, their dimensions fall within the scope of the term nanoparticle, as the term is used in the art. The red blood cells simply absorb the auranofin, therefore the still contain hemoglobin in their core. The instant specification indicates that red blood cells (erythrocytes) contain the claimed polyunsaturated fatty acids and that the hemoglobin and auranofin sensitize bacteria to oxidant killing. As such, the disclosure of Herrlinger falls entirely within the scope of instant claims 1 and 4-9, 15, and 16. With regard to claim 17, the in vitro experiments fall within the scope of “pharmaceutically acceptable carrier or excipient” because in vivo media to support cells contain substances that are pharmaceutically acceptable excipients.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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