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 .
Claims 1-17 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements filed 7/11/24 and 11/7/25 have been considered and an initialed copies are enclosed.
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.
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 1-3, 6-13 and 16-17 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.
The claims are drawn to composition for rearing an organism of fish, comprising at least one elected from the group consisting of lacticin, bacterial cells or a cell culture product of a bacterium having a lacticin gene, and an extract of the bacterial cells or the cell culture product.
The claims are drawn to a composition for preventing or treating a disease caused by Lactococcus garvieae in fish, comprising at least one selected from the group consisting of lacticin, bacterial cells or a cell culture product of a bacterium having a lacticin gene, and an extract of the bacterial cells or the cell culture product.
The claims are drawn to a method for rearing an organism of fish, comprising applying the composition according to claim 1 to the organism of fish.
The claims are drawn to a method for preventing or treating a disease caused by Lactococcus garvieae in fish, comprising applying the composition according to claim 2 to the organism of fish.
The claims are drawn to a growth inhibitor or a bactericide for Lactococcus garvieae, comprising at least one selected from the group consisting of lacticin, bacterial cells or a cell culture product of a bacterium having a lacticin gene, and an extract of the bacterial cells or the cell culture product.
The scope of lacticin encompasses peptides comprising SEQ ID NO: 1 or fragments of SEQ ID NO: 1 (lacticin is a peptide containing an amino acid sequence set forth in SEQ ID NO: 1), a lacticin having an amino acid sequence having 69% or more identity with an amino acid sequence set forth in SEQ ID NO: 1; and lacticin that contains an amino acid sequence formed by deletion, substitution, insertion and/or addition of 1 or more and 16 or less amino acid residues in an amino acid sequence set forth in SEQ ID NO: 1.
Thus, the genus of lacticin encompasses numerous species with different structure.
Furthermore, the claims require extract or cell culture product of the genus of a bacterium having the lacticin gene. This encompasses a genus that comprises any subcellular component of such a bacterium or any cell culture product of such a bacteria.
The specification does not disclose the common structure of the genus of lacticin peptides that possess lacticin function and can be used for preventing or treating a disease caused by Lactococcus garvieae in fish.
The specification does disclose the common structure of the genus of extracts and cell culture products of a bacterium having a lacticin gene encoding for lacticin or any of the lacticin variants that can be used for preventing or treating a disease caused by Lactococcus garvieae in fish.
The specification discloses two lacticin peptides lacticin Q (SEQ ID NO: 1 and lacticin Z (SEQ ID NO: 3). SEQ ID NO: 1 and SEQ ID NO: 3 are 97.1% identical. The specification also discloses an aureocin peptide SEQ ID NO: 4 that has 72.1 % identity to SEQ ID NO: 1. This aureocin A53 family peptide is from Curtobacterium sp and does not have lacticin activity despite having an amino acid sequence 72.1% identical with SEQ ID NO: 1. See paragraphs 17-18 of the specification.
Thus, the disclosure of SEQ ID NO: 1, 3 and SEQ ID NO: 4 are not a representative number of the genus of lacticin peptide variants that function the same as lacticin Q or Z and that can prevent or treat disease caused by L. garvieae.
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 function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Even though the one of ordinary skill in the art can screen for members of the genus of lacticin peptide variants that have lacticin activity and can prevent or treat L. garvieae in fish, the written description provision of 35 U.S.C. § 112 is severable from its enablement provision Vas-Cath, Inc. v. Mahurkar, 1115 and possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69USPQ2d at 1895.
For these reasons, Applicants as of effective filing date were not in possession of the genus of lacticin peptides that have lacticin function and that can be used to prevent or treat diseases caused by Lactococcus garvieae in fish and for the same reasons not in possession of the genus of bacterial cell or cell culture of a bacterium having a gene encoding lacticin or lacticin variants and extracts and cell culture of said bacterial cells.
Applicants as of the effective filing date were in possession of lacticin Q comprising the amino acid sequence set forth in SEQ ID NO: 1, lacticin Z comprising the amino acid sequence set forth in SEQ ID NO: 3, bacterium cells having lacticin gene encoding SEQ ID NO: 1 or SEQ ID NO: 3 and cell culture products thereof and extract or cell culture products of said bacterium wherein the extract and cell culture products comprises lacticin Q comprising the amino acid sequence set forth in SEQ ID NO: 1 or comprise lacticin Z comprising the amino acid sequence set forth in SEQ ID NO: 3 for preventing or treating disease caused by Lactococcus garvieae in fish.
Claims 5, 14 and 15 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. This is a biological deposit rejection.
The specification lacks complete deposit information for the deposit of bacterium is NITE BP-03536. Because it is not clear that the bacteria with the properties of NITE BP-03536 are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims requires NITE BP-03536, a suitable deposit for patent purposes is required. Exact replication of the plasmid is an unpredictable event.
Applicant's referral in the specification to the deposit of the bacteria in the National Institute of Technology and Evaluation NITE Patent Microorganisms Depositary (NPMD, Address: Room 122, 2-5-8, Kazusakamatari, Kisarazu, Chiba, Japan 292-0818) in accordance with the Budapest Treaty under Accession Number: NITE BP-03536 (Receipt Number: NITE ABP-03536) (Date of receipt: Sep. 14, 2021) is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR §1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
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.
Claims 1, 3-11 and 16-17 are 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 claims recite “organism of fish”. Fish is a organism so it is not clear what “organism of fish” is referring to. Until clarification of the metes and bounds of “organism of fish”, this recitation will be interpreted as “fish”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 and 12-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim(s) recite(s) a lacticin, bacterial cells or a cell culture product of a bacterium having a lacticin gene and an extract of the bacterial cells or the cell culture product. The claims recite that the lacticin is a peptide containing any sequence of (a) to (c) and having antibacterial activity: (a) an amino acid sequence set forth in SEQ ID NO: 1, (b) an amino acid sequence having 69% or more identity with an amino acid sequence set forth in SEQ ID NO: 1, and (c) an amino acid sequence formed by deletion, substitution, insertion, and/or addition of 1 or more and 16 or less amino acid residues in an amino acid sequence set forth in SEQ ID NO: 1.
STEP 1: THE CLAIMS ARE DRAWN TO A COMPOSITION OF MATTER.
STEP 2A PRONG ONE – THE CLAIM RECITES A JUDICIAL EXCEPTION -SEE MPEP 2106.4
The lacticin, lacticin variants, bacteria comprising said lacticin, extract and cell culture of the bacteria are products of nature. NITE BP-03536 was isolated from pickled chives and lacticin was isolated from the NITE BP-03536. In addition, lacticin Z and lacticin Q are products of cell culture of Lactococcus Lactis. Extracts of bacterial cells and having lacticin gene and cell culture thereof encompasses lacticin or subcellular organelles, nucleic acids, polysaccharides etc. The process of isolation does not change the structure of the lacticin or other extract of the bacterial cell or cell culture as it were in the Lactococcus lactis. Lacticin that are variants of SEQ ID NO: 1 also exist as product of nature e.g. lacticin Z or lacticin Q or aureocin. See paragraph 18 of the specification.
Regarding the feed or feed additive or rearing water or rearing water additive, these encompass a nature based composition as there could be two products of nature mixed together. For example, products of nature such as water, milk, sucrose, glucose can be combined with the lacticin or extract or cell culture product or bacterium having lacticin gene. There is no evidence that combining these results in a composition that is markedly different from the components as they exist in nature, respectively. There is also no evidence that the combination of products react together in any manner. See Ass 'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2117 (2013). Therefore, the combination is a nature-based product that may not exist in nature and thus the combination is compared to each of the products as they occur in nature. The broadly recited feed or feed additive or rearing water or rearing water additive are judicial exceptions.
The combination of natural products should be contrasted with cases like Chakrabarty where the Supreme Court found that, in contrast to the mixture of bacteria in Funk Brothers, “the patentee ha[d] produced a new bacterium (four plasmids were introduced into the bacterium) with markedly different characteristics from any found in nature and one having the potential for significant utility.” Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).
(“Natural phenomena, including naturally occurring organisms, are not patentable.”). See In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335-1336 (Fed. Cir. 2014). Supreme Court precedent teaches that neither isolating natural products nor combining them together represents an act of invention that would transform these naturally occurring products into patent eligible subject matter unless their combination results in something "markedly different”. See Ass 'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2117 (2013).
In Funk Brothers, “bacteria produced by the laboratory methods of culture [were] placed in a POWDER … base and packaged for sale to and used by agriculturists in the inoculation of the seeds of leguminous plants.” Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 129 (1948). Nevertheless, the Supreme Court concluded that such a mixture of bacteria was not patent eligible: “The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.” Id. at 130. Thus, the Supreme Court did not find that routine production and extraction steps resulted in a product that was "markedly different" from the product of nature including the production of “powder” composition.
STEP 2A PRONG TWO – THE CLAIM DOES NOT RECITE ADDITIONAL ELEMENTS THAT INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION. SEE MPEP 2106.4
Next, the claim as a whole is analyzed to determine whether any additional element or combination of elements that integrates the judicial exception into a practical application is recited.
The claims do not recite additional elements that integrate the judicial exception into a practical application such a particular treatment or prophylaxis for a disease or medical condition i.e. affirmatively reciting an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of said action is a step of administering/applying the composition to the fish and not merely an intended uses of the composition as recited in the all the claims. See MPEP 2106.04(d)(2).
STEP 2B – THE CLAIMS DO NOT AMOUNT TO SIGNIFICANTLY MORE. SEE MPEP 2106.05.
Next, the claims a whole is analyzed to determine whether any additional element, or combinations of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions. Integration requires an additional element in the claim to apply, rely on, or use the judicial exception in a manner than imposes a meaningful limit on the judicial exception. The claims do not recite any meaningful additional limitations, modification(s) or transformation(s) that sufficiently ensures that the claim amounts to significantly more than the exceptions.
Thus, the claims as a whole does not amount to significantly more than the “product of nature” by itself. Thus, the claims does not qualify as eligible subject matter under 35 USC 101.
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.
(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(s) 1-4, 6,7, 12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujita et al. Applied and Environmental Microbiology, Vol. 73, No. 9, p. 2871-2877, May 2007, cited in IDS.
Claim 1: Fujita et al disclose a composition for rearing an organism of fish, comprising lacticin Q or Lactococcus Lactis (L. lactis) cells or a cell culture product of Lactococcus lactis having a lacticin gene (culture supernatant) or an extract of the bacterial cells or the cell culture product i.e. culture supernatant or lacticin Q purified from the culture supernatant. See under p. 2872 left column under bacterial strains and culture conditions, Bacteriocin purification, mass spectrometry and amino acid sequencing and DNA sequence analysis, p. 2873 table 2, p. 2874 left column and figure 4.
Claim 2: Fujita et al disclose a composition for preventing or treating a disease caused by Lactococcus garvieae in fish, comprising lacticin Q or Lactococcus Lactis (L. lactis) cells or a cell culture product of Lactococcus lactis having a lacticin gene (culture supernatant) or an extract of the bacterial cells or the cell culture product i.e. culture supernatant or lacticin Q purified from the culture supernatant. See under p. 2872 left column under bacterial strains and culture conditions, Bacteriocin purification, mass spectrometry and amino acid sequencing and DNA sequence analysis, p. 2873 table 2, p. 2874 left column and figure 4.
Claim 3: Fujita et al disclose that the lacticin Q peptide has an amino acid sequence that comprises the amino acid sequence set forth in SEQ ID NO: 1 which is 100% identical to SEQ ID NO: 1. See p. 2874 including fig. 3 and fig. 4.
Claim 4: Fujita et al disclose the lacticin is lacticin Q. See portions cited above.
Claim 6: Claim 6 is drawn to the intended use of the composition for rearing an organism of fish wherein the fish belongs to the order Perciformes or the Order Salmoniformes.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim 7: The composition of Fujita et al can be regarded as a feed additive or a rearing water additive since it is capable of being added to animal feed or rearing water.
Claim 12: Fujita et al disclose a growth inhibitor for Lactococcus garvieae, comprising lacticin Q or Lactococcus Lactis (L. lactis) cells or a cell culture product of Lactococcus lactis having a lacticin gene (culture supernatant) or an extract of the bacterial cells or the cell culture product i.e. culture supernatant or lacticin Q purified from the culture supernatant. See under p. 2872 left column under bacterial strains and culture conditions, Bacteriocin purification, mass spectrometry and amino acid sequencing and DNA sequence analysis, p. 2873 table 2, p. 2874 left column and figure 4.
Regarding claim 14, said lacticin Q of Fujita et al is considered an extract of NITE BP-03536 because the lacticin Q of Fujita et al and that of the instant application SEQ ID NO: 1 are 100% identical.
Claim(s) 1-2, 6-10, 12 and 16 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Tang et al. CN 107183356 9-22-2017.
Claim 1: Tang et al disclose a composition for rearing an organism of fish, comprising a cell culture product of a bacterium having a lacticin gene – Bacillus YS-45, yeast S-78 and Aspergillus niger PL-39 is cultured to obtain a fermentation culture to obtain taurine enriched lacticin feed.
Claim 2: Tang et al disclose a composition for preventing or treating a disease caused by Lactococcus garvieae in fish, comprising a cell culture product of a bacterium having a lacticin gene – Bacillus YS-45, yeast S-78 and Aspergillus niger PL-39 is cultured to obtain a fermentation culture to obtain taurine enriched lacticin feed.
Claim 6: Claim 6 is drawn to the intended use of the composition for rearing an organism of fish wherein the fish belongs to the order Perciformes or the Order Salmoniformes.
Claim 7: Tang et al disclose that the fermentation culture is used to obtain taurine enriched lacticin feed which is regarded to a feed, feed additive and rearing water additive.
Claims 8, 9, and 16: Tang et al disclose a method of rearing an organism of fish or a method for preventing a disease caused by Lactococcus garvieae in fish, comprising applying the composition comprising a cell culture product of a bacterium having a lacticin gene – Bacillus YS-45, yeast S-78 and Aspergillus niger PL-39 is cultured to obtain a fermentation culture to obtain taurine enriched lacticin feed to the organism of fish. Here, “organism of fish” is interpreted as “fish”. Tang et al discloses the method step of claim 9.
Claim 10: Tang et al disclose the applying is by oral administration - taurine enriched lacticin feed is applied to aquaculture of fish:
“example 2: test using the single factor test design, selecting initial weight is about 10 g of the grass carp, randomly divided into 4 treatment, each process 3 repeats, each repeat 20 fishes and breeding aquaculture innovate in the Changsha University…feeding for 3 times every day… fish meal dosage is 51%, respectively using 24%, 34% and 44% lacticins feed to replace fish meal dosage…”.
Claim 12: Tang et al disclose a growth inhibitor or a bactericide for Lactococcus garvieae comprising a cell culture product of a bacterium having a lacticin gene – Bacillus YS-45, yeast S-78 and Aspergillus niger PL-39 is cultured to obtain a fermentation culture to obtain taurine enriched lacticin feed.
Claim(s) 1-4, 6-12, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ousterout et al. WO 2022/235799 10/11/2022.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim 1-4, 6-7 and 12: Ousterout et al disclose a composition comprising Lacticin Q or a growth inhibitor or bactericide for Lactococcus garvieae comprising said lacticin Q. (paragraph 105, 245). The lacticin Q is a peptide containing an amino acid sequence set forth in SEQ ID NO: 1 or contains an amino acid sequence having 96.2% sequence identity to SEQ ID NO: 1. See sequence alignment of SEQ ID NO: 1 with SEQ ID NO: 50 (see table at page 93) of Ousterout et al. Claim 6 refers to the intended use of the composition for rearing an organism of fish. Claim 7 the composition is capable of being a feed, feed additive, rearing water additive or suitable for injection.
Claims 8-11, 16 and 17: Ousterout et al disclose that the composition is administered to fish that has or is susceptible to an infection, wherein the fish is salmon, tuna, salmon, tilapia, catfish, carp, trout, cod, bass, perch, snapper (i.e. fish belonging to the order Perciformes or order Salmoniformes). Thus, Ousterout et al disclose a method for rearing an organism of fish and a method for preventing a disease caused by L. garvieae in fish. See paragraph 233. Ousterout et al disclose the composition is administered to the fish orally or by injection (paragraph 132, 176).
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Claim(s) 1-4, 6,7, 12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shoko et al. WO 2006033352 3-30-2006.
Claim 1-4, 6-7, 12 and 14: Shoko et al disclose a composition comprising Lacticin Q or a growth inhibitor or bactericide for Lactococcus garvieae comprising said lacticin Q. . Shoko et al disclose a composition comprising L. lactis having the lacticin Q gene. The lacticin Q is a peptide containing an amino acid sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 3 and contains an amino acid sequence having 100% sequence identity to SEQ ID NO: 1 and 96.8% sequence identity to SEQ ID NO: 3. See sequence alignment of SEQ ID NO: 1 and SEQ ID NO: 3 below. Claim 6 refers to the intended use of the composition for rearing an organism of fish. Claim 7 the composition is capable of being a feed, feed additive, rearing water additive or suitable for injection. See entirety of Shoko et al.
Regarding claim 14, said lacticin Q of Shoko et al is considered an extract of NITE BP-03536 because the lacticin Q of Shoko et al and that of the instant application SEQ ID NO: 1 are 100% identical.
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Claim(s) 1-4, 6-7 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Upton et al. WO 2011073663 6-23-2011.
Claim 1-4, 6-7 and 12: Upton et al disclose a composition comprising Lacticin Z or a growth inhibitor or bactericide for Lactococcus garvieae comprising said lacticin Z. Upton et al disclose a composition comprising a bacterial cell having the lacticin Z gene. The lacticin Z is a peptide containing an amino acid sequence that is 100% identical to SEQ ID NO: 3 (lacticin Z sequence of the instant application. The lacticin Z peptide of Upton et al contains an amino acid sequence having 97.1 % sequence identity to SEQ ID NO: 1. See sequence alignment of SEQ ID NO: 1 and SEQ ID NO: 3 below. Claim 6 refers to the intended use of the composition for rearing an organism of fish. Claim 7 the composition is capable of being a feed, feed additive, rearing water additive or suitable for injection. See entirety of Upton et al.
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Status of Claims
Claims 1-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645