Prosecution Insights
Last updated: October 04, 2026
Application No. 17/774,360

PHAGE COMPOSITIONS COMPRISING CRISPR-CAS SYSTEMS AND METHODS OF USE THEREOF

Final Rejection §112
Filed
May 04, 2022
Priority
Nov 06, 2019 — provisional 62/931,797 +1 more
Examiner
LIPPOLIS, ALEXANDRA ROSE
Art Unit
1637
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Locus Biosciences Inc.
OA Round
2 (Final)
47%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allowance Rate
15 granted / 32 resolved
-13.1% vs TC avg
Strong +59% interview lift
Without
With
+59.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
59 currently pending
Career history
95
Total Applications
across all art units

Statute-Specific Performance

§101
5.7%
-34.3% vs TC avg
§103
42.9%
+2.9% vs TC avg
§102
18.4%
-21.6% vs TC avg
§112
26.4%
-13.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 32 resolved cases

Office Action

§112
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 . This action is in response to the amendment filed 02/02/2026, in which claims 176, 190, 191, 194 and 195 were amended, claims 177, 179, 180, 183, 184, 192 and 193 were canceled, claims 181, 182, 185-189 and 196 were previously presented and claims 197-203 were newly added. Claims 176, 181, 182, 185-191, 194-203 are currently pending. Applicant’s arguments have been thoroughly reviewed, but are not persuasive for the reasons that follow. Any rejection and objections not reiterated in this action have been withdrawn. This action is FINAL. Response to Amendments - Specification The previous objection to the specification has been withdrawn in view of Applicant’s amendments to the claims filed on 02/02/2026. Response to Amendments - Claim Objections The previous objection to the claim 180 has been withdrawn in view of Applicant’s amendments to the claims filed on 02/02/2026. 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 176, 181, 182, 185-191 and 194-203 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is a previous rejection made in the Office Action mailed on 10/01/2025 and re-written to address the amendments filed on 02/02/2026. Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. The specification, while being enabling for a method of inhibiting growth of at least one strain of Escherichia in a subject in need thereof, the method comprising administering to the subject a combination of bacteriophages comprising a first bacteriophage, a second bacteriophage, and at least a third bacteriophage, wherein the first bacteriophage is p004k-5 (PTA-126319), wherein the second bacteriophage is p00jc-2 (PTA-126325), wherein the third bacteriophage is p00ex-2 (PTA-126324) wherein the first bacteriophage, the second bacteriophage, and the third bacteriophage are capable of infecting and lysing the Escherichia, and wherein the combination is capable of increased growth inhibition of the Escherichia compared to the first bacteriophage, the second bacteriophage, or the third bacteriophage alone, does not reasonably provide enablement for a method of inhibiting growth of at least one strain of Escherichia in a subject in need thereof, the method comprising administering to the subject a combination of bacteriophages comprising a first bacteriophage, a second bacteriophage, and at least a third bacteriophage, wherein the first bacteriophage is at least 90% identical to p004k-5 (PTA-126319), wherein the second bacteriophage is at least 95% identical to p00jc-2 (PTA-126325), wherein the third bacteriophage is at least 90% identical to p00ex-2 (PTA-126324) wherein the first bacteriophage, the second bacteriophage, and the third bacteriophage are capable of infecting and lysing the Escherichia, and wherein the combination is capable of increased growth inhibition of the Escherichia compared to the first bacteriophage, the second bacteriophage, or the third bacteriophage alone. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Nature of the invention: The claims are directed to a method of treating an infection associated with Escherichia in a subject in need thereof, the method comprising administering to the subject a combination comprising a first bacteriophage and a second bacteriophage, wherein the first bacteriophage is a recombinant bacteriophage comprising a CRISPR array comprising a spacer sequence complementary to a target nucleotide sequence in the Escherichia, wherein the second bacteriophage is at least 95% identical to p00jc-2 (PTA-126325), wherein the first bacteriophage and the second bacteriophage are capable of infecting and lysing the Escherichia, and wherein the combination is capable of increased growth inhibition of the Escherichia compared to the first bacteriophage or the second bacteriophage alone. The claim also recites the first bacteriophage is at least 90% identical to p004k-5 (PTA-126319). It is understood that the bacteriophages are to be a part of the bacterial cell packaging system listed in claims 176 and 177. The nature of the invention is complex in that the administration of the bacteriophage to a subject must be capable of treating an infection. Further, the administration of the two bacteriophages must provide increased growth inhibition of Escherichia compared to the first or second bacteriophage alone. Moreover, the nature of the invention is complex in that the claims encompass the administration of variants of deposited phage, where the variants are defined by sequence identity to a deposit rather than a provided base sequence. Breadth of the claims: The claims are drawn to a method of treating an infection associated with a-Escherichia in a subject in need thereof wherein the method comprises administering to the subject in need a first bacteriophage and second bacteriophage. Wherein the first bacteriophage is a recombinant bacteriophage comprising a CRISPR array comprising a spacer sequence complementary to a target nucleotide sequence in the Escherichia wherein the first bacteriophage is at least 90% identical to p004k-5 (PTA-1263190) and wherein the second bacteriophage is at least 95% identical to p00jc-2 (PTA-126325) and the third bacteriophage is at least 90% identical to p00ex-2 (PTA-126324). The claims continue to limit that the first, second and third bacteriophage are capable of infecting and lysing the Escherichia as well as in combination is capable of increased growth inhibition of the Escherichia compared to the first and second bacteriophage. The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. Guidance of the specification and existence of working examples: The specification includes in the material and methods section, the process of the base bacteriophage manufacturing and its comparative function to the wild type as well as the process of experimentation using the bacteriophages in cocktail combinations of three or more bacteriophages. With respect to the bacteriophages p00jc-2 (PTA-126325), p004k-5 (PTA-126319) and p00ex-2 (PTA-126324), the specification teaches that the bacteriophages were Ml3 phagemids derived from the base pBAD18 plasmid and modified to accommodate Type I-E CRISPR ribonucleic acids (crRNAs) [0232]. The bacteriophages modified with a CRISPR system were then tested in cocktail combinations of three or more to show inhibition of growth and killing of E. coli (e.g., paragraph [0345]). Examples 1-3 describe the steps manufacturing the CRISPR enhanced bacteriophage using T7M phages (produced the CRISPR enhanced crT7M phage), T4 phages (produced the CRISPR enhanced crT4 phage) and T7 phages (produced the CRISPR enhanced crT7 phage) (Pages 88-92). These examples also demonstrate the ability of the CRISPR enhanced phage’s ability to inhibit E. coli growth as well as kill E. coli (Page 92-95). Example 4 continues with the evaluation of the host range and durability of each CRISPR-enhanced phage (crPhage) and the 3-phage combined cr-Phage cocktail [0250]. Examples 5 and 6 both provide an evaluation of phages against E. coli in the mouse UTI model wherein example 5 evaluates two phages, WT and crPhage cocktail, and example 6 evaluates two phage cocktails, wtPhage cocktail and crPhage cocktail (derived from the same wtPhage), against E. coli strain LFP527 in the mouse UTI infection model (Page 96-101). Examples 7-9 provides an evaluation of phages against E. coli in the mouse UTI model as well as pooled results from examples 7 and 8 (Pages 102-112). Example 7 was to evaluate two phage products, phage cocktail and Pyophage (a commercially available cocktail of bacteriophage, sold by Eliava Biopreparations), against E. coli strain LFP 527 in the mouse UTI infection model, wherein the Phage cocktail was a mixture of phages p0033L-10 (ATCC No. PTA-126316), p004k-5 (ATCC No. PTA-126319), and p0071-16 (ATCC No. PTA-126320) (Page 102). Example 8 was to evaluate the dose-response of phage cocktail against E. coli strain LFP 527 in the mouse UTI infection model. In addition, the virulence of three other E. coli strains was evaluated in the model, wherein the Phage cocktail was a mixture of phages p0033L-10 (ATCC No. PTA-126316), p004k-5 (ATCC No. PTA-126319), and p0071-16 (ATCC No. PTA-126320) (Page 105). Finally, example 9 was pooled results with the objective of these studies was to evaluate the engineered bacteriophage (crPhage) cocktail against Escherichia coli (E. coli) strain LFP 527 in the mouse urinary tract infection (UTI) model (Page 108). An Example 10 was not provided within the specification. Examples 11-15 provide tolerability studies, in vivo experimentation, in vitro kill curves, dose toxicity in mice and persistence and distribution of crPhages in the urinary and GI tract. Examples 16 and 17 provide the crPhage and LBP-EC01 cocktail and there individual and combined effectiveness across host ranges. Example 16 specifically teaches ten crPhage candidates identified in Table 25 were assigned into different cocktail combinations of 3 to 6 phages and provides the cocktail tested with a combination of 3 or more phages showed a host range of greater than 80% [0345]. Example 17 teaches crPhage cocktail LBP-EC0I is composed of phages identified in Table 26 was tested against a panel of 176 E. coli isolates by mixing bacteria and phage at a defined MOI and measuring optical density growth curves for approximately 20 hours [0346]. Finally, Example 18 provides a multi-center randomized, double-blind study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of phage cocktail in patients with lower urinary tract colonization caused by E. coli, including proposed indication, study design, study population, study objective and endpoints, patient duration and anticipated risks to human subjects. However, none of the examples provide the specific sequence or deposited information for the bacteriophages used within the claims. As well as the Phage names within Table 25 are not the complete as compared with the phage names used within the claims. Furthermore, the combination of bacteriophages used and tested throughout most of the examples references phages p0033L-10 (ATCC No. PTA-126316), p004k-5 (ATCC No. PTA-126319), and p0071-16 (ATCC No. PTA-126320) but does not include p00jc-2 (PTA-126325) which is required by the claims. The examples also reference the crPhage cocktails require three or more of the CRISPR enhanced phages but the claims only reference two specific phages. The specification also currently envisions treatment or inhibition of E. coli, however, the exact combination claimed within the claims is not tested in any of the working examples. Therefore, although the specification shows the process and experimentation that occurred to reach the product known as bacteriophages p00jc-2 (PTA-126325), p004k-5 (PTA-126319) and p00ex-2 (PTA-126324) there is no way for an individual with ordinary skill in the art to reached the same product that was created from the experimentation of the claimed invention with complete certainty without the full and complete structure and/or sequence provided. Predictability and state of the art: For some relevant background, Oechslin, Frank (Viruses 2018, 10, 351, pgs 1-23) teaches bacteria can resist phage attack through different mechanisms, including spontaneous mutations, restriction modification systems, and adaptive immunity and spontaneous mutations are the main mechanisms driving both phage resistance and phage–bacterial coevolution such as phage resistance by modifying the structure of bacterial surface components that act as phage receptors and that also determine phage specificity (Page 1, Paragraph 2). Oeschlin teaches that with E. coli, specifically, some phage treatments resulted in no resistance and treatment of the bacteria while other phage treatments resulted in phage resistant bacteria and non-successful treatment of the E. coli bacteria (Page 3, Table 1). Thus, showing that phage treatment of E. coli is unpredictable to whether the bacteria will develop resistance to the phage as well as treatment of the bacteria itself. Duan et al (Antimicrobial Resistance.Front. Microbiol. 12:716064, pgs. 1-9, 2021) provides a lengthier discussion of an engineered bacteriophage comprising a CRISPR-Cas system for the treatment of a target bacterium infection (Page 1, Abstract). However, even Duan admits that although studies have shown the strong potency in bacterial killing using the CRISPR-Cas antimicrobials, there are still colonies survived by escaping genome (Page 6, Column 2). Duan teaches that several factors mainly contribute to the emerged resistance against CRISPR-Cas antimicrobials in the escaped colonies, such as the spontaneous mutations in the Cas genes or the target sequences, spacer excision owing to the homologous recombination between the repeats, presence of the anti-CRISPR (Acr) genes in the target host genomes, and repressed expression/activity of cas proteins (Page 6, Column 2). Through further research, it is known in the art that bacteriophage genomes themselves are extremely diverse. Hatfull et al (Curr Opin Virol. 2011 October 1; 1(4): 298–303) teaches that the current state of bacteriophage genomes shows a vast genetic diversity due to phages being highly active in evolutionary changes for billions of years creating horizontal genetic exchange (Page 1, Abstract). This has created what Hatfull explains as a result in the genomes of phages becoming pervasively mosaic (Page 1, Abstract). Hatfull teaches, “Nucleotide sequence comparison of bacteriophage genomes reveals them to be enormously diverse. For example, unless any given phage genome has a known close relative that infects the same host, or there is a closely-related prophage, it is unusual to find extensive nucleotide sequence similarity to other database entries.” (Page 3, first full paragraph). Thus, demonstrating that even by following the same experimentation that was completed for the purpose of creating the specific bacteriophages listed in the specification, it is highly unpredictable whether the same bacteriophage genomes would be obtained as claimed in the invention. Amount of experimentation necessary: In order to practice the claimed invention, an immense amount of experimentation would be required. As discussed above, the specification itself provides the process of creation of the bacteriophages and the process of selection. The specification does not define, by structure or full sequence, the bacteriophage genome used within the claims. Therefore, experiment could be conducted, but in view of the specification there does not appear to be any amount of experiment that would be sufficient to reliably produce the exact sequence or structure of the bacteriophage. Such experimentation would not be possible due to the bacteriophage structure or full sequence being provided within the specification. Therefore, it would require an immense amount of unpredictable experimentation to practice the claimed invention with such variants of bacteriophage genomes as broadly claimed. In view of the breadth of the claims and the lack of guidance provided by the specification as well as the unpredictability of the art, the skilled artisan would have required an undue amount of experimentation to make and/or use the claimed invention. Therefore, claims 176, 181, 182, 185-191 and 194-203 are not considered to be fully enabled by the instant disclosure. Claims 176, 181, 182, 185-191, 194-203 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. This is a previous rejection made in the Office Action mailed on 10/01/2025 and re-written to address the amendments filed on 02/02/2026. Claims 176 is drawn to a genus of bacteriophage. The rejected claims thus comprise a genus of bacteriophage that encompass a first bacteriophage that is at least 90% identical to p004k-5 (PTA-126319), a second bacteriophage is at least 95% identical to p00jc-2 (PTA-126325) and a third bacteriophage is at least 90% identical to p00ex-2 (PTA-126324). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof. The specification teaches a bacteriophage comprising a nucleic acid sequence comprising (a) a first CRISPR array designed to be operable with a first Type I CRISPR-Cas system and (b) a second CRISPR array designed to be operable with a second Type I CRISPR-Cas system and wherein the bacteriophage is capable of killing a target bacterium by lytic activity [0003-0004 and 0074-0077]. The specification envisions different attributes of the bacteriophage, such as lytic activity, target host bacterium, CRISPR cas functions, that are important to the construction and functions of the bacteriophage [0003-0004 and 0074-0077]. The specification envisions that the bacteriophage can be PTA-126317, PTA-126320, PTA-126316, PTA-126324, PTA-126315, or PTA-126319 [0005-0014]. No description is provided of the specific structure of the bacteriophage as well as the specific depository information required to verify that sample has been deposited. The prior art does not appear to offset the deficiencies of the instant specification in that it does not describe a set of bacteriophages that are the specific strains as outlined in the specification as p00jc-2 (PTA-126325), p004k-5 (PTA-126319) and p00ex-2 (PTA-126324). Arnaud et al (Nat Commun 8, 1953, pgs. 1-9; 2017) teaches that the structure of the bacteriophage is determined by the target host bacterium and with different bacterium calls for different bacteriophage structure features, such as phage tail proteins (Page 2, Column 1). Seed et al (mBio, 2(1), e00334-10, pgs. 1-10; 2011) teaches that even within the same bacterium, Vibrio cholerae, the different bacteriophages were capable of different functions, such as the ICP2 bacteriophages being capable of forming plaques on multiple V. cholerae strains whereas the ICP1 bacteriophages were only capable of targeting V. choleraeO1 (Page 2, Column 1 bridging Column 2). This shows that the different structure of the bacteriophage, even if miniscule, effects the capabilities and functions of the bacteriophage to target specific bacterium strains effectively. Therefore, the skilled artisan would have reasonably concluded applicants were not in possession of the claimed invention for claims 176, 181, 182, 185-191 and 194-203. Claim Rejections - 35 USC § 112 The previous rejection of claims 176, 177 and 179-196 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement due not having the proper information for the deposited strain under the Budapest treaty, has been withdrawn in view of Applicant’s remarks filed on 02/02/2026. The previous rejection of claims 176, 181, 182, 185-191 and 194-203 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement has been maintained in view of Applicant’s amendments to the claims filed on 02/02/2026. Applicant’s arguments have been fully considered but have not been found to be persuasive. Applicant argues a method of inhibiting growth of at least one strain of Escherichia in a subject, the method comprising administering to said subject a combination of at least three bacteriophages as recited in amended claim 176 and in particular, the first bacteriophage, second bacteriophage, and at least third bacteriophage have a defined sequence identity to specified bacteriophages, which Applicant argues they have demonstrated are surprisingly and unexpectedly effective at inhibiting Escherichia bacteria growth when combined. Applicant continues that the present application provides examples and guidance for one of ordinary skill in the art to make and use a bacteriophage cocktail having at least the three recited bacteriophages for inhibiting growth of at least one strain of Escherichia, as claimed; and thus, it would not entail undue experimentation to practice the instantly claimed method involving inhibiting growth of at least one strain of Escherichia in a subject by administering a bacteriophage combination having at least three bacteriophages including a first bacteriophage having at least 90% identity to p004k-5 (PTA-126319), a second bacteriophage having at least 95% identity to p00jc-2 (PTA-126325), and an at least third bacteriophage having at least 90% identity to p00ex-2 (PTA-126324), in view of the specification as filed. However, the newly rewritten scope of enablement provides that while the specification is enabled for a method of inhibiting growth of at least one strain of Escherichia in a subject in need thereof, the method comprising administering to the subject a combination of bacteriophages comprising a first bacteriophage, a second bacteriophage, and at least a third bacteriophage, wherein the first bacteriophage is p004k-5 (PTA-126319), wherein the second bacteriophage is p00jc-2 (PTA-126325), wherein the third bacteriophage is p00ex-2 (PTA-126324) wherein the first bacteriophage, the second bacteriophage, and the third bacteriophage are capable of infecting and lysing the Escherichia, and wherein the combination is capable of increased growth inhibition of the Escherichia compared to the first bacteriophage, the second bacteriophage, or the third bacteriophage alone, does not reasonably provide enablement for a method of inhibiting growth of at least one strain of Escherichia in a subject in need thereof, the method comprising administering to the subject a combination of bacteriophages comprising a first bacteriophage, a second bacteriophage, and at least a third bacteriophage, wherein the first bacteriophage is at least 90% identical to p004k-5 (PTA-126319), wherein the second bacteriophage is at least 95% identical to p00jc-2 (PTA-126325), wherein the third bacteriophage is at least 90% identical to p00ex-2 (PTA-126324) wherein the first bacteriophage, the second bacteriophage, and the third bacteriophage are capable of infecting and lysing the Escherichia, and wherein the combination is capable of increased growth inhibition of the Escherichia compared to the first bacteriophage, the second bacteriophage, or the third bacteriophage alone. This is due to the bacteriophages being deposited under the Budapest Treaty and only being publicly available after a patent is issued. Therefore, there is no way of knowing if the percentage identity of each bacteriophage would impose an infringement issue due to not knowing the exact structure and/or sequence of the bacteriophages. As well as, there is no way to replicate the current limitations without knowing the exact structure and/or sequence of the claimed bacteriophages. The previous rejection of claims 176, 181, 182, 185-191 and 194-203 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 has been maintained in view of Applicant’s amendments to the claims filed on 02/02/2026. Applicant’s arguments have been fully considered but have not been found to be persuasive. Applicant argues the specification as filed discloses multiple bacteriophages, including those recited in amended method claim 176, and their corresponding ATCC patent deposit numbers, which are provided in Table lA of the specification (Page 43 bridging Page 44 and Para. [0126-0127]). Applicant continues to argue that the specification teaches bacteriophages having at least 90% sequence identity to a bacteriophage deposited under ATCC Patent Deposit number PTA-126319 (i.e., p004k-5) and PTA-126324 (i.e., p00ex-2); specifically, Page 47 further discloses bacteriophages having at least 95% sequence identity to a bacteriophage deposited under ATCC Patent Deposit number PTA-126325 (i.e., p00jc-2). Applicant argues that the compositions comprising a plurality of bacteriophages, can include at least three bacteriophages, such as those p004k-5, p00jc-2, or p00ex-2, and bacteriophages having specific sequence identity thereto, are described for instance starting at page 48. However, while the specification provides written description for a method of inhibiting growth of at least one strain of Escherichia in a subject in need thereof, the method comprising administering to the subject a combination of bacteriophages comprising a first bacteriophage, a second bacteriophage, and at least a third bacteriophage, wherein the first bacteriophage is p004k-5 (PTA-126319), wherein the second bacteriophage is p00jc-2 (PTA-126325), wherein the third bacteriophage is p00ex-2 (PTA-126324) wherein the first bacteriophage, the second bacteriophage, and the third bacteriophage are capable of infecting and lysing the Escherichia, and wherein the combination is capable of increased growth inhibition of the Escherichia compared to the first bacteriophage, the second bacteriophage, or the third bacteriophage alone, the specification does not provide written description for the first bacteriophage being at least 90% identical to p004k-5 (PTA-126319), the second bacteriophage being at least 95% identical to p00jc-2 (PTA-126325) and the third bacteriophage being at least 90% identical to p00ex-2 (PTA-126324). This is due to the bacteriophages being deposited under the Budapest Treaty and only being publicly available after a patent is issued. Therefore, there is no way of knowing if the percentage identity of each bacteriophage would impose an infringement issue due to not knowing the exact structure and/or sequence of the bacteriophages. As well as, there is no way to replicate the current limitations without knowing the exact structure and/or sequence of the claimed bacteriophages. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER A DUNSTON can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637 /CELINE X QIAN/Primary Examiner, Art Unit 1637
Read full office action

Prosecution Timeline

May 04, 2022
Application Filed
Oct 01, 2025
Non-Final Rejection mailed — §112
Feb 02, 2026
Response Filed
May 13, 2026
Final Rejection mailed — §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
47%
Grant Probability
99%
With Interview (+59.0%)
3y 11m (~0m remaining)
Median Time to Grant
Moderate
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