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 .
DETAILED ACTION
Priority
Acknowledgement is made of Applicant’s claimed domestic priority under 35 U.S.C. § 119(e), of U.S. Provisional Application Serial No. 63/531,942, filed 08/10/2023.
Status of the Claims
The amendment dated 11/08/2015 is acknowledged. Claims 1-5, 7, 9, 11, 13, 15-19, 30 and 32-36 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Abstract
The Abstract of the disclosure is objected to because of the following informalities:
The Abstract exceeds the word limit for the application. See MPEP 608.01(b)
608.01(b) Abstract of the Disclosure [R-9]
37 C.F.R. 1.72 Title and abstract.
(b) A brief abstract of the technical disclosure in the specification must commence on a separate sheet, preferably following the claims, under the heading "Abstract" or "Abstract of the Disclosure." The sheet or sheets presenting the abstract may not include other parts of the application or other material. The abstract in an application filed under 35 U.S.C. 111 may not exceed 150 words in length. The purpose of the abstract is to enable the United States Patent and Trademark Office and the public generally to determine quickly from a cursory inspection the nature and gist of the technical disclosure.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet preferably within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc. In addition, the form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided.
Appropriate correction is required.
Drawings
The drawing filed on 08/26/2024 are acknowledged and accepted by the Examiner.
Specification
The disclosure is objected to because of the following informalities: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pages 10, 13 and 24). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Appropriate correction is required.
Claim Objections
Claims 1, 3-5, 7, 9, 13, 15-19, 30, 32 and 34-35 are objected to for the following informalities:
Claim 1 recites sequences with no sequence identifier, for example, “nucleic acid sequence encoding KEN1, KEN10 and AFR43”. The claims are required to include a sequence identification number (SEQ ID NO.) for each polypeptide. MPEP 1.821 states “(d) Where the description or claims of a patent application discuss a sequence that is set forth in the "Sequence Listing" in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:" in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application”. Appropriate corrections are required.
3-5, 7, 9, 13, 15-19, 30, 32 and 34-35 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 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.
Claims 2 and 33 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 2 (steps iii, iv, v) and 33 contain parentheses. The use of parentheses in the claim makes the range of concentrations indefinite in that it is unclear whether the range is exemplary or a limitation of the claim invention. See MPEP § 2173.05(d).
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. “Wang” (Virus Evolution, 2023, 9(2):1-12, IDS of record dated 09/10/2024).
Note: The claim recites “optionally”; thus, the limitations from said optional language are understood by the Office to not be required in determining a rejection based on the prior art.
The claim is directed to a method of expanding the activity of therapeutic phages, comprising steps of:
i. mixing taxonomically similar phages with complimentary lytic activity, wherein the taxonomically similar phages are, optionally, one or more selected from KEN1, KEN10, AFR43, KEN22, KEN25, KEN37, and KEN39;
ii. passaging mixed phages against a panel of phage-resistant bacterial clinical isolates, wherein the phage-resistant bacterial clinical isolates are, optionally, one or more selected from PAO1, MRSN 20176, MRSN414780, and MRSN 15882;
iii. pooling lysates from wells showing reduction in bacterial growth to form pooled lysate
iv. repeating steps (i)-(iii) using the pooled lysate;
V. identifying plaque formation on phage-resistant strains using pooled lysate;
vi. isolating phage clones from plaques formed in step (iv) to obtain candidate phages, and
vii. assessing host range of candidate phages; and
viii. optionally, assessing stability via serial propagation against single strain and re-assessing host range.
Regarding claim 1, Wang discloses mixing taxonomically similar phages “phage training to minimize bacterial phage resistance and to improve treatment outcome by adapting the phage to their target hosts during co-evolution. We isolated and characterized a novel Pseudomonas aeruginosa N4-like lytic phage (PWJ) from wastewater in Yangzhou, China. PWJ is a double-stranded DNA podovirus that can efficiently lyse the model strain ATCC 27,853 and opportunistic pathogen PAO1. Genome sequencing of PWJ revealed features similar to those of the N4-like P. aeruginosa phage YH6. We used PWJ to screen for an evolved trained phage (WJ_Ev14) that restored infectivity to PWJ phage bacterial resisters. BLASTN analysis revealed that WJ_Ev14 is identical to its ancestor PWJ except for the amino acid substitution R1051S in its tail fiber protein. Moreover, phage adsorption tests and transmission electron microscopy of resistant bacteria demonstrated that the R1051S substitution was most likely the reason WJ_Ev14 could re-adsorb and regain infectivity. Furthermore, phage therapy assays in vitro and in a mouse P. aeruginosa lung infection model demonstrated that PWJ treatment resulted in improved clinical results and a reduction in lung bacterial load whereas the joint phage cocktail (PWJ+ WJ_Ev14) was better able to delay the emergence of resister bacteria. The phage cocktail (PWJ +WJ_Ev14) represents a promising candidate for inclusion in phage cocktails developed for clinical applications” (Abstract). Wang discloses The taxonomy ranks were as follows: Realm, Duplodnaviria; Kingdom Heunggongvirae; Phylum Uroviricota; Order Caudoviricetes; Family Schitoviridae; Subfamily Migulavirinae; Genus Litunavirus. Briefly, the wastewater samples were filtered through a Millex-GP 0.22μm membrane (Millipore, Burlington, MA, USA) and the filtrate was incubated with P. aeruginosa strains ATCC 27,853 and PAO1 overnight at 37∘C with shaking at 200 rpm. The newly discovered phage PWJ detected from spot testing and single plaques were selected, purified, and diluted in SM buffer (page 2 second column, first para. (instant claim steps i and ii)). Wang discloses Bacterial adaptation to phage PWJ was experimentally performed with three replicates. Briefly, in 2mL LB medium, 200μL fresh lysate of phage PWJ and 200μL ATCC 27,853 from a single ancestral P. aeruginosa colony were incubated together at 37∘C at a multiplicity of infection (MOI) of 1. In 48h intervals, samples were taken and centrifuged at 2700×g and the cell pellets were suspended in fresh LB that was then inoculated with phage PWJ at MOI=1 and incubated again for another interval. This process was repeated for five transfers over 10 d. At each transfer, bacterial CFU and phage PFU were measured and a total of 30 evolved mutants were also randomly selected (instant step iv). Following the final interval, the bacterial were again pelleted and suspended in LB and spread-plated on LB agar to recover bacterial survivors. Spot assays and cross streaking against the ancestral phage were then used to determine phage PWJ resistance in the evolved bacteria (page 2 section 2.2.1, Culture-based phage resister selection and coevolved phage screening) (instant steps v and vi). Further, Wang discloses phage training by Experimental phage counteradaptation to phage-resistance was experimentally performed with three replicates whereby a stationary-phase phage-resistant mutant culture was combined with 20μL ATCC 27,853 from a single ancestral P. aeruginosa colony incubated together at 37∘C until the OD600nm reached∼0.3. A 200μL sample of a fresh PWJ lysate was added followed by incubation at 37∘C for 5h. The mixed samples were filtered through a 0.22μm membrane twice and one aliquot was used for another round of adaptation. The other aliquot was used for spot assays and cross streaking against the ancestral bacteria and phage resistant mutant (section 2.2.2, Phage training) (instant steps vii and viii).
Therefore, the cited prior art anticipates the claimed invention.
Conclusion
Claims 11 and 36 appear to be free of the prior art and deemed allowable. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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