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
The present application remains examined under applicant’s election with traverse of Group II in the reply filed on 11/10/2025.
Claims 1-8 and 15 remain withdrawn as being directed to a non-elected invention.
Claims 9-14 and 16-21 are directed to the elected invention and have been examined on their merits.
Amendments
Claim 9 now requires the method to comprise contacting a bacteriophage lytic for at least Listeria serovar 1/2* and/or serovar 3, said bacteriophage having a genome that has at least 90% sequence identity with the genome of bacteriophage P100 as set forward in SEQ ID NO: 1, and wherein the distal part of the receptor binding protein as set forward in SEQ ID NO: 4 has at least the mutation E97K or contacting a composition comprising said bacteriophage to a food product or to food processing equipment to reduce the amount of Listeria.
Claims 16-21 are newly added.
Nucleotide and/or Amino Acid Sequence Disclosures
Previous requirement for sequence disclosure
Applicant has provided the requisite REFERENCE TO AN ELECTRONIC SEQUENCE LISTING paragraph.
Claim Objections
Claim 18 is 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:
(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.
(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.
Previous rejections under 35 U.S.C. § 112
RE: Rejection of claims 9-14 under 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
Claims 9-14 were previously rejected for failing to comply with the deposit requirement. Without acquiescing to the merits of the rejection, applicant has amended claim 9, as shown above, to remove reference to bacteriophages P100+ and P200 deposited under accession numbers CBS146750 and CBS146751.
Accordingly, the rejection under 35 U.S.C. § 112(a) for biological deposit is withdrawn.
RE: Rejection of claims 9-14 under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Claims 9-14 were previously considered to not have sufficient written description because they encompasses methods of using bacteriophages having 70% sequence identity with the genome of bacteriophage P100 as set forward in SEQ ID NO: 1.
Without acquiescing to the merits of the rejection, applicant has amended claim 9 to require at least 90% sequence identity to SEQ ID NO: 1. Applicant asserts that the increased percentage sequence identity combined with the mandatory E97K mutation in the receptor binding protein is sufficient to fulfil the written description requirement.
Applicant’s arguments have been fully considered but are not considered to be sufficient to meet the written description requirement.
Applicant has not provided any rationale for why the 90% sequence homology cut-off is considered to meet the written description requirement. As discussed in the rejection of record, applicant has disclosed two bacteriophages having the recited E97K mutation (P100+ and P200). These bacteriophages are derived from bacteriophages P100 and A511, which the prior art (Klumpp) recognized were “very similar” and “morphologically indistinguishable”, with “strong sequence homologies” (p. 3, right col., par. 2). Klumpp further teaches that A511 is a “close relative” of P100 (p. 5, right col., par. 2). As discussed in the rejection of record, SEQ ID NO: 1 is 131,384 bases in length and therefore 90% identity allows for a variation of as many as 13,138 bases while still falling within the scope of the claim.
Thus, when considering applicant’s disclosure, applicant has described the mutation in two largely indistinguishable bacteriophages which are known in the art to be “close relatives” and description of mutants of these two bacteriophages is not sufficient to meet the written description requirement for any mutant bacteriophage having 90% sequence similarity to SEQ ID NO: 1.
For at least this reason, the rejection of record must be maintained. However, in order to address applicant’s amendments to the claims, the rejection has been withdrawn and new grounds of rejection are set forth below.
RE: Rejection of claims 9-14 under 35 U.S.C. 112(a) because the specification, while being enabling for controlling contamination in a food product with some compositions, does not reasonably provide enablement for doing the same with all compositions covered by the scope of the claims.
Claims 9-14 were rejected for scope of enablement. Specifically, it was considered that the invention was enabled for bacteriophages having E97K or E97K, E104D, and Y131H but not enabled for G157R, E104D, or Y131H alone.
Without acquiescing to the merits of the rejection, applicant has amended claim 9 to require at least E97K.
Because the claims now require a mutation which is enabled, the rejection of record is withdrawn.
New grounds of rejection under 35 U.S.C. § 112
Claims 9-14, 16-17, and 19-21 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The claims contain 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 at the time the application was filed, had possession of the claimed invention.
Claim 9 is broadly directed to a method comprising “contacting a bacteriophage lytic for at least Listeria serovar 1/2* and/or serovar 3, said bacteriophage having a genome that has at least 90% sequence identity with the genome of bacteriophage P100 as set forward in SEQ ID NO: 1, and wherein the distal part of the receptor binding protein as set forward in SEQ ID NO: 4 has at least the mutation E97K or contacting a composition comprising said bacteriophage to a food product or to food processing equipment to reduce the amount of Listeria”.
Therefore, the scope of the claims broadly allows for the use of any bacteriophage having at least E97K on SEQ ID NO:4 and at least 90% sequence identity to bacteriophage P100 (genome described by SEQ ID NO: 1).
In order to satisfy the written description requirement for applicant’s broad claim to a method of using any bacteriophage having the at least one mutation and having at least 90% sequence identity with the bacteriophage P100, applicant must disclose sufficiently detailed, relevant identifying characteristics. These characteristics include the complete or partial structure, other physical or chemical properties, or functional characteristics when coupled with a known or disclosed correlation between function and structure. Additionally, applicant may meet this requirement by sufficiently describing a representative number of species within the claimed genus.
Klumpp et al. (Bacteriophage, 2013, vol. 3(3), pages 1-8) teaches that Listeria serovars 1/2 are particularly susceptible to phage infection and no phages have been reported for serovar 3 strains which are highly refractory to phage infection (p. 1, right col., par. 1-3). Applicant has disclosed two sets of mutations (E97K or E97K, E104D, and Y131H) which enhance the host range of P100 and A511 to include lytic activity against Listeria 1/2* and 3 serovars. Accordingly, applicant has disclosed two bacteriophages (P100+ and P200) having at least an E97K on SEQ ID NO: 4 among the large group of bacteriophages having at least 90% sequence identity to SEQ ID NO: 1 (i.e., any bacteriophage differing by as many as 13,138 bases).
And although it is acknowledged that applicant has demonstrated the enhanced host range by testing variants of two bacteriophages (P100 and A511), this is not sufficient to meet the disclosure requirement for every bacteriophage covered by the breadth of applicant’s claims because applicant has only disclosed two bacteriophages which are very similar in sequence identity and characteristics. For example, Klumpp teaches that the genomes of A511 and P100 are “very similar” and “morphologically indistinguishable”, with “strong sequence homologies” (p. 3, right col., par. 2). Klumpp further teaches that A511 is a “close relative” of P100 (p. 5, right col., par. 2). Thus, when considering the breadth of the groups actually disclosed by the specification, applicant has only demonstrated possession of a mutant of P100 and its “close relative” and a person having ordinary skill in the art would not clearly recognize applicant’s possession of a representative number of Listeria phages from the large group of phages having “at least 90%” sequence identity to SEQ ID NO: 1.
For at least these reasons, applicant’s disclosure does not satisfy the written description requirement.
Claims 10-14 depend from claim 9 and do not substantially narrow the breadth of the claims such that one skilled in the relevant art that the inventor at the time the application was filed would recognize applicant’s possession of the claimed invention.
Claims 16-17 is newly added and limit the bacteriophage to require a second and/or third mutation selected from combinations of E97K with G157R, E104D, and/or Y131H. For the same reasons discussed above, disclosure of two closely related bacteriophages is not sufficient to provide written description for any bacteriophage having the recited mutations and 90% sequence identity to SEQ ID NO: 1.
Claim 19 merely limits the activities of the bacteriophages and does not substantially narrow the breadth of the claims such that one skilled in the relevant art that the inventor at the time the application was filed would recognize applicant’s possession of the claimed invention.
Claims 20-21 further require an agent or an organic acid. As discussed above, the claims broadly encompass any bacteriophage having at least 90% sequence identity to SEQ ID NO: 1 and the E97K mutation. Further incorporation of other components (such as the recited agents or organic acid) is not sufficient to demonstrate possession of the large group of bacteriophages claimed in the independent claim.
Claims 21 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 21 limits the composition used in claim 9 to further comprise “an organic acid, or a salt thereof”. The claim then introduces a group by the phrase “such as wherein the organic acid is selected from the group consisting of…”.
First, description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim (MPEP § 2173.05(d)). In this case, it is not clear if the organic acids covered by this group are required by the claim because they are introduced with exemplary language (“such as”).
Second, it is unclear if this group is describing only the organic acids or if it is also describing the base acids for the “salts thereof”. For example, the group includes “lactic acid” and it is unclear if applicant is reciting “lactic acid” and salts of “lactic acid” because the group is “the organic acid” (not “the organic acid or salt thereof”.
The claim then continues by reciting “such as wherein the salt of the organic acid is selected from the group consisting of…”. Again, it is unclear if these salts are the only salts encompassed by the claim or if they are exemplary salts.
Finally, the claim concludes with specific salts (“such as K-(L)lactate, Na-(L)lactate…”). It is unclear if the claim is limiting the salts of “organic acid” to only include these specific salts or if they are merely exemplary.
In the interest of compact prosecution, these limitations are considered to be optional. Nonetheless, the claim should be amended to distinctly define the metes and bounds and exemplary embodiments should be found in the specification, not the claims.
Claim 21 is further considered to be indefinite because it requires the composition administered in claim 9 to further comprise “an organic acid, or a salt thereof” (i.e., a singular element) but allows for a plurality of organic acids, or salts thereof by virtue of the “mixtures thereof” language. Accordingly, the scope of the claim is unclear. For example, it is not clear how “an organic acid” can be a mixture of lactic acid, acetic acid, and propionic acid.
Conclusion
Claims 9-14, 16-17, and 19-21 are not allowable.
Claim 18 is allowable if placed in independent form but is objected to for being dependent on a rejected claim.
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 GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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/GRANT C CURRENS/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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