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 .
The preliminary amendment to the claims submitted on 10/7/25 has been entered. Claims 1, 3, 6, 9, 12, 17, 29, 33, 35, 39, 42, 50-51, 59, 63-65, 69, 74, 76 and 80 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/1/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because several drawings contain labels and other texts that are ineligible. Please review and amend accordingly. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 17 and 42 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 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.
The claimed invention requires a recombinant bacteriophage has at least 80% sequence identity with a bacteriophage selected from any one of the following: p004k (ATCC Accession No. PTA-127149), p00ex (ATCC Accession No. PTA-127145), p00c0 (ATCC Accession No. PTA- 127143), p00jc (ATCC Accession No. PTA-127147), p5516 (ATCC Accession No. PTA- 127151), p6921 (ATCC Accession No. PTA-127576), and p6984 (ATCC Accession No. PTA- 127578), and p00ke (ATCC Accession No. PTA-127148) and wherein bacteriophage are selected from any one of the following: p00exe299, p004ke127, p00jce098, p00exe296, and p00kee072.
The application does not disclose sequence information for these claimed bacteriophages or bacteriophages having at least 80% sequence identity to the claimed bacteriophage.
It is apparent that these bacteriophages, including those within the scope of 80% identity are required to practice the claimed invention because they are a necessary limitation for the success of the invention as stated in the claims. As a required element it must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of the bacteriophages within the scope of 80% identity. See 37 CFR 1.802. One cannot determine whether a bacteriophage has the necessary characteristics without access to these bacteriophages. Therefore, access to bacteriophages is required to practice the invention. The specification does not provide a repeatable method for producing these bacteriophages without access to the claimed bacteriophages and it does not appear to be readily available material.
Deposit of bacteriophages that are within the scope of the 80% identity of the bacteriophages in a recognized deposit facility would satisfy the enablement requirements of 35 U.S.C. 112., because the strains would be readily available to the public to practice the invention claimed, see 37 CFR 1.801- 37 CFR 1.809.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of this application, access to the invention will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803 - 37 CFR 1.809 for additional explanation of these requirements.
Claims 51, 59 and 63 are rejected under 35 U.S.C. 112, first paragraph, as containing 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.
Applicant broadly claims a host cell or expression vector or nucleic acid containing the nucleic acids of claims 51, 59 and 63. The claims read on a cell within a transgenic animal or a transgene therein given that the term "isolated" is not denoted in describing the host cell, nucleic acid, or expression vector.
With respect to the unisolated host cells and transgenes as “nucleic acids” or “expression vectors “of the instant claims discussed above, the state of the art at the time of filing was such that one of skill could not predict the phenotype of transgenics. The art of transgenic animals has for many years stated that the unpredictability lies, in part, with the site or sites of transgene integration into the target genome and that "the position effect" as well as unidentified control elements are recognized to cause aberrant expression of a transgene (Wall et Al., Theriogenology, Vol. 45, Pg. 57-68, 1996).
The elements of the particular construct used to make transgenic animals are also held to be critical, and they must be designed case by case without general rules to obtain good expression of a transgene; e.g., specific promoters, presence or absence of introns, etc. (Houdebine et Al., Journal of Biotechnology, Vol. 34, Pg. 269- 287, 1994). Furthermore, transgenic animals are regarded to have within their cells, cellular mechanisms that prevent expression of the transgene, such as methylation or deletion from the genome (Kappell et Al., Current Opinions in Biotechnology, Vol. 3, Pg. 548-553, 1992). Houdebine (Comparative Immunology, Microbiology, and Infectious Diseases, Vol. 32, Pg. 107-121, 2009) teaches progress has been made in the field of transgenic animals for production of foreign proteins (Abstract); however, constructing an efficient expression vector to produce a therapeutic protein is not a standard operation (Pg. 116, Paragraph, second). Therefore, undue experimentation is required to make and use a transgene and transgenic animal to produce the antibody and antibody fragments of the instant claims.
Examples in the literature aptly demonstrate that even closely related species carrying the same transgene construct can exhibit widely varying phenotypes. Mullins (1993, Hypertension, Vol. 22, No. 4, pp. 630-633) states that not all animals express a transgene sufficiently to provide a model for a disease as the integration of a transgene into different species of animal has been reported to give divergent phenotypes. For example, several animal models of human diseases have relied on transgenic rats when the development of mouse models was not feasible. Mullins (1990, Nature, Vol. 344, 541-544) produced outbred Sprague-Dawley x WKY rats with hypertension caused by expression of a mouse Ren-2 renin transgene. Hammer (1990, Cell, Vol. 63, 1099- 1112) describes spontaneous inflammatory disease in inbred Fischer and Lewis rats expressing human class I major histocompatibility allele HLA-B27 and human 02- microglobulin transgenes. Both investigations were preceded by the failure to develop human disease-like symptoms in transgenic mice expressing the same transgenes that successfully caused the desired symptoms in transgenic rats (Mullins, 1989, EMBO J., Vol. 8, pages 183-191). Thus, the use of nonmurine species for transgenesis will continue to reflect the suitability of a particular species for the specific questions being addressed, bearing in mind that a given construct may react very differently from one species to another.
The examiner notes here, in addition to these issues, even assuming arguendo a person having ordinary skill in the art could make a host organism with functional transgene that encodes the instantly recited SEQ ID NO: 1, there is no predictability that the host will survive its expression. The transgene depends on the host for function and harm to the host, including death, renders the transgene nonfunctional and thus not enabled.
The art is well-aware of side effects caused by expressing proteins, such as therapeutic antibodies. In a transgenic cell or animal that expresses the same, the antibody will exert any possible side effect it can. It is not administered but chronically present and so such side effects are chronic and potentially more serious than any from an administered antibody. Hansel (Nature Reviews Drug Discovery, Vol. 9, Pg. 325-337, 2010) teaches in their table 1 on page 328 numerous exemplary side effects from licensed monoclonal antibodies to include: increased bleeding risk, infection, heart failure, cancer, thyroid disorder, autoimmune reactions, and cytokine release syndrome (CRS) to name only a few. One or more such effects, or similar, may occur with the therapeutic antibody instantly recited when administered and indeed be exacerbated by chronic exposure due to internal expression. The instantly encoded antibody binds a mammalian protein and so may very well target related or unrelated proteins in the transgenic host, leading to such side effects. For all these reasons, previously raised and new, transgenes are not enabled.
At the time of filing, the phenotype of a transgene and transgenic cell contained within any animal was unpredictable. The claims as written, encompassing a transgene and cell in a transgenic animal, is not adequately described in the specification as to prevent excessive experimentation by the public to generate and use the invention. Applicants can obviate the instant rejection by amending the claim to recite the term "isolated" before the recitation, "host cell" and by amending the vector and polynucleotide claims to specify they are not in a transgenic animal. Applicant may consider using purified in such claims if description is appropriate for such a term and it is not redefined away from standard meaning. Method claims using these products should also carry the appropriate adjectives above.
In view of the lack of the predictability of the art to which the invention pertains as evidenced by the art above, the lack of guidance and direction provided by Applicant, and the absence of working examples, undue experimentation would be required to make and use transgenic animals possessing the claimed host cells, nucleic acid, or expression vector, with a reasonable expectation of success, absent a specific and detailed description in Applicant’s specification of how to effectively practice this and absent working examples providing evidence which is reasonably predictive that the claimed host cell, nucleic acid, or expression vector, commensurate in scope with the claimed invention. The same can be said for the transgenes and transgenic animals encompassed by the instant claims. Thus, the claims are rejected here.
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.
Claim(s) 1, 3, 6, 20, 50 and 80 are rejected under 35 U.S.C. 102a1 as being anticipated by Gabant (US PGPub 20150050253).
The claimed ivnetion is drawn to a recombinant bacteriophage comprising a nucleic acid sequence encoding a Colicin 10, Colicin Ib, Colicin M, Colicin E1 or Colicin K.
The Colicin 10 has at least 80% identity to SEQ ID NO: 166.
The Colicin Ib has at least 80% identity to SEQ ID NO: 165.
The Colicin E1 has at least 80% identity to SEQ ID NO: 178.
The composition comprising a first and a second bacteriophage.
Gabant teach the use “techniques of genetically modifying microorganisms are well known in the art. In some embodiments, a microorganism is genetically modified to comprise nucleic acid sequence regulating the expression of, and encoding, at least one of bacteriocins, immunity modulators, industrially useful molecules, poison molecules, or antidote molecules. Polynucleotides can be delivered to microorganisms, and can be stably integrated into the chromosomes of these microorganisms, or can exist free of the genome, for example in a plasmid, extrachromosomal array, episome, minichromosome, or the like.” [see paragraph 60]
[0061] “Exemplary vectors for genetic modification of microbial cells include, but are not limited to, plasmids, viruses (including bacteriophage), and transposable elements. Additionally, it will be appreciated that entire microbial genomes comprising desired sequences can be synthesized and assembled in a cell (see, e.g. Gibson et al. (2010), Science 329: 52-56). As such, in some embodiments, a microbial genome (or portion thereof) is synthesized with desired features such as bacteriocin polynucleotide(s), and introduced into a microbial cell.”
Gabant teach at paragraph 110: “In some embodiments, the kits contain at least one of bacteriocins, bacteriocin polynucleotides, immunity modulators, immunity modulator polynucleotides, other genetic elements (such as promoters, expression vectors, conjugation plasmids, and the like), genetically engineered microbial cells, and/or culture medium as described herein. In some embodiments, the kits further contain packaging, and/or instructions for use of the contents therein. In some embodiments, the kits comprise a variety of bacteriocins, for example for use in ascertaining the effects of a candidate bacteriocin or combination thereof on a culture environment. In some embodiments, the kits comprise a variety of bacteriocin polynucleotides and immunity modulator polynucleotides, for example for constructing a microbial cell with desired characteristics…”
Examples of the bacteriocin polynucleotides are provided in Tables 1 and 2, which provides amino acid and nucleic acid sequences for Colicin Ib, K and M. Therefore, Gabant teach the formation of a bacteriocin polynucleotide that encodes Colicins, including Colicins Ib, K and M. Gabant also teach that bacteriocins kill microbial cells, and “Neutralizing activity of bacteriocins can include arrest of microbial reproduction, or cytotoxicity. Some bacteriocins have cytotoxic activity (e.g. "bacteriocide" effects), and thus can kill microbial organisms, for example bacteria, yeast, algae, synthetic micoorganisms, and the like. Some bacteriocins can inhibit the reproduction of microbial organisms (e.g. "bacteriostatic" effects), for example bacteria, yeast, algae, synthetic micoorganisms, and the like, for example by arresting the cell cycle.” [see paragraph 29 and claim 15]
Specific nucleic acid sequences for Colicin 10, Ib, K, and E1 are provided by Gabant. SEQ ID NO: 52 represents the amino acid sequence of Colicin 10, which is identical to SEQ ID NO: 166 of the instant invention; SEQ ID NO: 54 represents the amino acid sequence of Colicin E1, which is identical to SEQ ID NO: 178 of the instant invention; SEQ ID NO: 52 represents the amino acid sequence of Colicin Ib, which is identical to SEQ ID NO: 165 of the instant invention.
Therefore, Gabant anticipate the instant invention.
Claim(s) 51, 59 and 69 are rejected under 35 U.S.C. 102a1 as being anticipated by Gabant (US PGPub 20150050253).
A composition comprising a first nucleic acid encoding a first Colicin, and a second nucleic acid encoding a second Colicin, wherein: i) the first Colicin comprises Colicin Ib, and the second Colicin comprises Colicin 10, Colicin M, Colicin U, or Colicin K; ii) the first Colicin comprises Colicin 10, and the second Colicin comprises Colicin U or Colicin K; iii) the first Colicin comprises Colicin U, and the second Colicin comprises Colicin K; iv) the first Colicin comprises Colicin M, and the second Colicin comprises Colicin K; or v) the first Colicin comprises Colicin M, and the second Colicin comprises Colicin U.
The composition further comprising a third Colicin, wherein:
i) the first nucleic acid encodes Colicin Ib, the second nucleic acid encodes Colicin 10, and the a third nucleic acid encodes Colicin U; ii) the first nucleic acid encodes Colicin lb, the second nucleic acid encodes Colicin M, and the third nucleic acid encodes Colicin K;
iii) the first nucleic acid encodes Colicin Ib, the second nucleic acid encodes Colicin U, and the third nucleic acid encodes Colicin K; iv) the first nucleic acid encodes Colicin 10, the second nucleic acid encodes Colicin U, and the third nucleic acid encodes Colicin K; v) the first nucleic acid encodes Colicin Ib, the second nucleic acid encodes Colicin M, and the third nucleic acid encodes Colicin U; or vi) the first nucleic acid encodes Colicin M, the second nucleic acid encodes Colicin K, and the third nucleic acid encodes Colicin U.
Gabant teach at paragraph 110: “In some embodiments, the kits contain at least one of bacteriocins, bacteriocin polynucleotides, immunity modulators, immunity modulator polynucleotides, other genetic elements (such as promoters, expression vectors, conjugation plasmids, and the like), genetically engineered microbial cells, and/or culture medium as described herein. In some embodiments, the kits further contain packaging, and/or instructions for use of the contents therein. In some embodiments, the kits comprise a variety of bacteriocins, for example for use in ascertaining the effects of a candidate bacteriocin or combination thereof on a culture environment. In some embodiments, the kits comprise a variety of bacteriocin polynucleotides and immunity modulator polynucleotides, for example for constructing a microbial cell with desired characteristics…”
Examples of the bacteriocin polynucleotides are provided in Tables 1 and 2, which provides amino acid and nucleic acid sequences for Colicin Ib, K and M. Therefore, Gabant teach the formation of a bacteriocin polynucleotide that encodes Colicins, including Colicins Ib, K and M. Gabant also teach that bacteriocins kill microbial cells, and “Neutralizing activity of bacteriocins can include arrest of microbial reproduction, or cytotoxicity. Some bacteriocins have cytotoxic activity (e.g. "bacteriocide" effects), and thus can kill microbial organisms, for example bacteria, yeast, algae, synthetic micoorganisms, and the like. Some bacteriocins can inhibit the reproduction of microbial organisms (e.g. "bacteriostatic" effects), for example bacteria, yeast, algae, synthetic micoorganisms, and the like, for example by arresting the cell cycle.” [see paragraph 29 and claim 15]
Therefore, Gabant anticipate the instant invention.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gabant as applied to claims 1, 3, 6, 20, 50 and 80 above, and further in view of Hamill et al. (US PGPub 20160339078).
The Colicin K has at least 80% identity to SEQ ID NO: 167.
While Gabant teach Colicin K, they do not teach an amino acid sequence with at least 80% identity to SEQ ID NO: 167.
Hamill et al. teach Colicin K (SEQ ID NO: 6101), which is identical to SEQ ID NO: 167 of the instant invention.
It would have been obvious to one of ordinary skill in the art to modify the compositions taught by Gabant in order to generate a bacteriophage encoding Colicin K having the same sequence of SEQ ID NO: 167. One would have been motivated to do so, given the suggestion by Gabant that bacteriophage can encode bacteriocins and they also teach the bacteriocin of Colicin K. There would have been a reasonable expectation of success, given the knowledge that Colicin K which is identical to SEQ ID NO: 167 was previously known, as taught by Hamill et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim(s) 29, 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Gabant as applied to claims 1, 3, 6, 20, 50 and 80 above, and further in view of Pham-Khanh et al. (Current Micrology, 2019, Vol. 76, pages 1130-1137) and Khalifeh et al. (Microbiology Resource Announcements, 2021, Vo. 10, Issue 5).
The claimed invention also requires that the bacteriophage is a Tequatrovirus phage comprising a nucleic acid sequence encoding Colicin K; a Phapecoctavirus phage comprising a nucleic acid sequence encoding Colicin 10; or a Myoviridae phage comprising a nucleic acid sequence encoding Colicin 10.
While Gabant teach bacteriophage can encode bacteriocins and they also teach the bacteriocin of Colicin K and 10, they do not teach a Tequatrovirus phage comprising a nucleic acid sequence encoding Colicin K; a Phapecoctavirus phage comprising a nucleic acid sequence encoding Colicin 10; or a Myoviridae phage comprising a nucleic acid sequence encoding Colicin 10.
Pham-Khanh et al. teach genome sequence of the isolated phage KIT03, which belongs to the Myoviridae family and genome Tequatrovirus. [see abstract and page 1132]
Khalifeh et al. teach the complete genome of Phapacoctavirus phage isolated from Pigeons. [see abstract and Figure 1]
It would have been obvious to one of ordinary skill in the art to modify the compositions taught by Gabant in order to generate a Tequatrovirus phage comprising a nucleic acid sequence encoding Colicin K; a Phapecoctavirus phage comprising a nucleic acid sequence encoding Colicin 10; or a Myoviridae phage comprising a nucleic acid sequence encoding Colicin 10. One would have been motivated to do so, given the suggestion by Gabant that bacteriophage can encode bacteriocins and they also teach the bacteriocins of Colicins K and 10. There would have been a reasonable expectation of success, given the knowledge that phages and the genomes of Tequatrovirus, Phapecoctavirus and Myoviridae, were previously known and studied, as taught by Pham-Khanh et al. and Khalifeh et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim(s) 39, 64, 74 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Gabant as applied to claims 1, 3, 6, 20, 50 and 80 above, and further in view of Burnett et al. (US PGPub 20090246336) and Joerger (Poultry Science, 2003, Vol. 82, pages 640-647).
The bacteriophage is a lytic bacteriophage
The bacteriophage is in methods to kill bacteria, to treat a disease in an individual, reducing resistance to a bacteriophage in a population of target bacteria, and in the reduction of levels of E. coli in a subject.
The teachings of Gabant are summarized above. While it is taught that the bacteriophage can manipulate microbes/bacteria and that bacteriocins can kill bacteria, they do not specifically teach administering bacteriophage to kill bacteria, to treat a disease in an individual, reducing resistance to a bacteriophage in a population of target bacteria, and in the reduction of levels of E. coli in a subject.
Burnett et al. teach administering bacteriophage and bacteriocins to kill bacteria, such as E. coli and the bacteriophage are lytic phages. [see paragraphs 31, 61 and 62]
Joerger teach administering bacteriophage to chickens in order to treat bacterial infections, such as E. coli. [see page 643, right column and left column of page 644]
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Gabant in order to kill bacteria (E. coli) in a subject or treating a disease in a subject. One would have been motivated to do so, given the suggestion by Gabant that bacteriocins can kill bacteria. There would have been a reasonable expectation of success, given the knowledge that bacteriophages can kill bacteria (e.coli) and treat bacteria in a subject, as taught by Burnett et al. and Joerger. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim(s) 63 is rejected under 35 U.S.C. 103 as being unpatentable over Gabant as applied to claims 51 and 59 above, and further in view of GenBank Accession Y11823 and CAA72509 (2016).
The claims invention also requires that the composition further comprising a fourth nucleic acid encoding a fourth Colicin, wherein the first nucleic acid encoding encodes Colicin Ib, the second nucleic acid encodes Colicin M, the third nucleic acid encodes Colicin U, and the fourth nucleic acid encodes Colicin K.
The teachings of Gabant are summarized above, however, while it is taught that more than one bacteriocin (colicin) can be encoded in a polynucleotide sequence, they do not teach that Colicin U is encoded.
GenBank Accession Y11823 and CAA72509 provide the nucleic acid and amino acid sequence for a Colicin U, which is identical to SEQ ID NO: 168 of the instant application.
It would have been obvious to one of ordinary skill in the art to modify the composition taught by Gabant in order to include nucleic acid sequence encoding Colicin U with their bacteriocin polynucleotide. One would have been motivated to do so, given the suggestion by Gabant that more than one bacteriocin, which includes colicins, can be encoded by a polynucleotide. There would have been a reasonable expectation of success, given the knowledge that nucleic acid and the corresponding amino acid sequence of a Colicin U was previously known, as taught by GenBank Accession Y11823 and CAA72509. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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