DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I, claims 10, 11, 13, 18, 19, 21, 23, 25, 27, 29, 31, 33, 34, 37, 40 and the Species: the first Lactobacillus reuteri strain wherein the strain encompasses a genomic nucleic acid sequence including SEQ ID NO: 49 and the second Lactobacillus reuteri strain wherein the strain encompasses a genomic nucleic acid sequence including SEQ ID NO: 44, in the reply filed on 5/5/26 is acknowledged. The traversal is on the ground(s) that the Species of ATCC PTA-126788 and ATCC PTA-126787, e.g., parts b) and c) of current claim 10, should be included in the initial examination since they contain the genomic nucleic acid sequences set forth in SEQ ID NOS: 49 and 44.
This has been fully and carefully considered and is persuasive, claim 10 will be examined as currently written in its entirety.
The requirement is still deemed proper and is therefore made FINAL.
Claims 43, 44, 47, 48, 50, 51 and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-2nd paragraph
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 10, 11, 13, 18, 19, 21, 23, 25, 27, 29, 31, 33, 34, 37, 40 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.
Claim 10, part (a), is vague and indefinite for the phrase “including SEQ ID NO:” because the term “including” is not understood since it means ‘part of a whole’ or ‘part of a group’ which leaves the metes and bounds of the claim uncertain. It is suggested the language be amended to “a strain comprising the genomic nucleic acid sequence set forth in SEQ ID NO:“ in order to clarify exactly what is being claimed. Appropriate clarification and/or correction is required.
Claim 10, part (b), is vague and indefinite because it recites a nucleic acid sequence without providing a sequence identifier. The mere recitation of a name, e.g., nucleic acid of sequence of ATCC strain, to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept The claim should provide any structural properties, such as the nucleic acid sequence, which would allow for one to identify the protein without ambiguity. The mere recitation of a name does not adequately define the claimed nucleic acid sequence and does not enable one to calculate a percentage identity of ‘variant sequences.’ It is suggested part b) and part c) be limited to “the isolated Lactobacillus reuteri ATCC strain PTA-126788 and the isolated Lactobacillus reuteri ATCC strain PTA-1267887,” respectively. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 112-Deposit Information
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 10, 11, 13, 18, 19, 21, 23, 25, 27, 29, 31, 33, 34, 37, 40 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 specification lacks complete deposit information for the deposit of strains Lactobacillus reuteri ATCC strain PTA-126788 and Lactobacillus reuteri ATCC strain PTA-1267887. Because it is not clear that the properties of the strain are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the plasmids, a suitable deposit for patent purposes is required.
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 the 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 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 the 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;
© the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent 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 non-viable or non-replicable.
In addition, a deposit of the biological material that is capable of self-replication either directly or indirectly must be viable at the time of the 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.
If the deposit was made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by Applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that 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 a deposit is 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 the deposit and the complete name and address of the depository is required.
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.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 112-Written Description
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 10, 11, 13, 18, 19, 21, 23, 25, 27, 29, 31, 33, 34, 37, 40 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, for example:
A method for reducing intestinal permeability, alleviating alcohol induced or disease related leaky gut syndrome, alleviating the intestinal and systemic effects of chronic alcohol consumption, including intestinal dysbiosis, and/or reducing inflammation, including intestinal-derived or intestinal-associated inflammation, comprising administering an effective amount of an immunogenic probiotic composition comprising an isolated first Lactobacillus reuteri strain and an isolated second Lactobacillus reuteri strain wherein:
(a) the isolated first Lactobacillus reuteri strain has a genomic nucleic acid sequence including at least one of SEQ ID NO: 49, sequences having one or more nucleic acid sequence difference from the sequence of at least one of SEQ ID NO: 49, sequences having at least one nucleic acid sequence difference from the sequence of at least one of SEQ ID NO: 49 and further having at least 97%, at least 98%, at least 99% or at least 99.5% sequence identity with one or more of SEQ ID NO: 49, sequences having at least 98%, at least 98.5%, at least 99%, or at least 99.5% sequence identity to SEQ ID NO: 49;
and and/or the isolated second Lactobacillus reuteri strain has a genomic nucleic acid sequence including at least one of SEQ ID NO: 44, sequences having one or more nucleic acid sequence difference from the sequence of at least one of SEQ ID NO 44, sequences having at least one nucleic acid sequence difference from the sequence of at least one of SEQ ID NO:44 and further having at least 97%, at least 98%, at least 99% or at least 99.5% sequence identity with one or more of SEQ ID NO 44, sequences having at least 98%, at least 98.5%, at least 99%, or at least 99.5% sequence identity to SEQ ID NO: 44;
or (b) the isolated first Lactobacillus reuteri strain comprises or has a genomic nucleic acid sequence corresponding to the genomic nucleic acid sequence of ATCC strain PTA-126788, or a variant thereof comprising or having a nucleic acid sequence at least 98%, at least 98.5%, at least 99%, or at least 99.5% sequence identity to the genomic nucleic acid sequence of ATCC strain PTA-126788, or is Lactobacillus reuteri strain 3632, which corresponds to ATCC Patent Deposit Number PTA-126788;
and the isolated second Lactobacillus reuteri strain comprises or has a genomic nucleic acid sequence corresponding to the genomic nucleic acid sequence of ATCC strain PTA-126787, or a variant thereof comprising or having a nucleic acid sequence at least 98%, at least 98.5%, at least 99%, or at least 99.5% sequence identity to the genomic nucleic acid sequence of ATCC strain PTA-126787, or is Lactobacillus reuteri strain 3630, which corresponds to ATCC Patent Deposit Number PTA-126787.
The instant claims are drawn to bacterial strains comprising genomic nucleic acid sequences with open-ended mutations at several positions and variant fragments. To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed bacterial strains in the claimed methods such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed. Applicants have not described the genus of bacterial strains possessing the claimed method functions such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed. The specification describes the isolation, identification and evaluation of two novel Limosilactobacillus reuteri (L. reuteri) isolates, ATCC PTA-126787 & ATCC PTA-126788. They sequenced the genomes of these two L. reuteri strains using the PacBio sequencing platform. These are unique strains with unique function. The specification does not teach the isolation of other strains or variants.
With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014).
The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). To satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02.
However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
Because the art is unpredictable and the scope of the claim includes numerous structural variants and the genus is highly variant because a significant number of structural differences between genus members is permitted. The specification does not describe any members of the claimed genus by complete structure. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
There are no drawings or structural formulas disclosed of any of thesefragments or variants of the claimed polynucleotides. There is no teaching in thespecification regarding which part of the structure can be varied and still produce a strain which has the recited therapeutic activities. Although the disclosure of SEQ ID NO: 44 and 49 combined with the knowledge in the art, may put one in possession of nucleic acid sequences that are at least 98-99.5% identical, the level of skill and knowledge in the art is such that one of ordinary skill would not be able to identify without further testing which of those strains would have the required functional activities. Based on the lack of knowledge and predictability in the art, those of ordinaryskill in the art would not conclude that the applicant was in possession of theclaimed genus of strains.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov
Claim Rejections - 35 USC § 112-Scope of Enablement
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 10, 11, 13, 18, 19, 21, 23, 25, 27, 29, 31, 33, 34, 37, 40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A method for reducing intestinal permeability, alleviating alcohol induced or disease related leaky gut syndrome, alleviating the intestinal and systemic effects of chronic alcohol consumption, including intestinal dysbiosis, and/or reducing inflammation, including intestinal-derived or intestinal-associated inflammation, comprising administering an effective amount of an immunogenic probiotic composition comprising an isolated first Lactobacillus reuteri strain and an isolated second Lactobacillus reuteri strain wherein:
(a) the isolated first Lactobacillus reuteri strain has the genomic nucleic acid sequence of SEQ ID NO: 49;
and the isolated second Lactobacillus reuteri strain has a genomic nucleic acid sequence including at least one of SEQ ID NO: 44;
or (b) the isolated first Lactobacillus reuteri strain is ATCC strain PTA-126788
and the isolated second Lactobacillus reuteri strain is ATCC strain PTA-126787.
does not reasonably provide enablement for the full scope of the instant claims.
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. The specification states that substitutions, additions, or deletions, may be made to the defined sequences; however, the specification provides no guidance as to what the nucleotides may be changed without causing a detrimental effect to Lactobacillus reuteri strains and their probiotic abilities and function in the methods as claimed. It is unpredictable as to which nucleic acids could be removed and which could be added. The position within the sequence where substitutions can be made with a reasonable expectation of success are limited. Other positions are critical to the structure/function relationship, e.g., such as various positions or regions directly involved in binding, catalysis in providing the correct three-dimensional spatial orientation of binding and catalytic sites. These regions can tolerate only very little or no substitutions. Applicants have not shown the particular substitution and the result it produces. Applicants have provided no guidance to enable one of ordinary skill in the art how to determine, without undue experimentation, the effects of different nucleic acid variations and the nature and extent of the changes that can be made. The instant claims allow for substitutions anywhere in the sequence s and they do not recite the specific changes in the claims.
Probiotic candidates are exposed to a variety of harsh extremes in the gastrointestinal tract, but acidic pH of the stomach and bile salts appear to be the dominant factors determining the survival and growth of probiotic candidates in the gastrointestinal tract. The chicken duodenum has a typical bile salt concentration of 0.175% and likewise, the human duodenum has a bile salt concentration of around 0.3% [92, 93]. Both of our L. reuteri strains showed a similar survival profile to that of commercially marketed probiotic L. reuteri DSM 17938 in the presence of 0.3% bile salts. The human and chicken (proventriculus) stomachs have a pH of around 1.5–4.0 [94, 95]. Both of our strains showed similar survival at pH 2.5,
The instant specification teaches the isolation and idenitifcation of two novel Lactobacillus reuteri (L. reuteri) isolates, ATCC PTA-126787 & ATCC PTA-126788. More specifically, the genomes of these two L. reuteri strains were sequenced using the PacBio sequencing platform. PTA-126787 (L. reuteri 3630) and PTA-126788 (L. reuteri 3632), isolated from broiler chickens possess favorable safety profiles. The two strains do not encode for any known genetic sequences of concern for human or animal health. In vitro assays confirmed that the strains are susceptible to clinically relevant antibiotics and do not produce potentially harmful by-products such as biogenic amines. In vitro bile and acid tolerance studies demonstrated that the two strains have good survival profiles. Probiotic candidates are exposed to a variety of harsh extremes in the gastrointestinal tract, but acidic pH of the stomach and bile salts appear to be the dominant factors determining the survival and growth of probiotic candidates in the gastrointestinal tract. The chicken duodenum has a typical bile salt concentration of 0.175% and likewise, the human duodenum has a bile salt concentration of around 0.3%. The human and chicken (proventriculus) stomachs have a pH of around 1.5–4.0. Both strains showed similar survival at pH 2.5.
Despite the prior safe use of a probiotic genus and species, the survival properties, efficacy, and safety of probiotics are evaluated on a strain-specific basis. Hence, screening for such properties for every new strain is required before any new probiotic candidate is accepted for human and animal consumption. Genomic characterizations are instrumental in selecting a safe and efficacious probiotic strain. Safety assessment begins with the correct identification of the probiotic candidate and this is important for both scientific and regulatory reasons. Genomic approaches offer high resolution identification of strains by comparing those with other well-characterized, safe, and efficacious probiotic strains. Comparative genomics studies further help to understand the molecular basis of probiotic efficacy, as well as the survival and adaptation of these probiotic strains in the gastrointestinal tract. Most importantly, genomic analyses allow for rapid screening of probiotic candidates for genes encoding antimicrobial resistance, virulence factors, toxins, and biogenic amines, facilitating better understanding of the safety of the probiotic strain of interest. Finally, genome-based analyses also help to investigate the stability of probiotic strains. Gangaiah et al (PLoS One (Jan 26, 2022), 17(1), e0262663, pages 1-26).
The specification provides in silico, in vitro and in vivo evidence to support the safety of L. reuteri ATCC PTA-126787 & ATCC PTA-126788 for their use as probiotics in humans as well as animals. More specifically, the strains were identified using a combination of biochemical, 16S rRNA and whole-genome sequencing analyses. The genomes were screened for potential genes encoding antimicrobial resistance, toxins, virulence factors and other harmful metabolites. In silico data were further confirmed using in vitro experiments. The strains were finally analyzed for safety using the broiler chicken as an in vivo model.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”
Status of Claims:
No claims are presently allowed.
Allowable subject matter:
The claimed methods which comprise administering and effective amount of a first Lactobacillus reuteri strain with a genomic nucleic acid sequence comprising SEQ ID NO: 49, and a second Lactobacillus reuteri strain with a genomic nucleic acid sequence comprising SEQ ID NO: 44; and methods which comprise administering isolated Lactobacillus reuteri ATCC strain PTA-126788 and Lactobacillus reuteri ATCC strain PTA-1267887, are free of the prior art.
The prior art does not teach or fairly suggest a method for reducing intestinal permeability, alleviating alcohol induced or disease related leaky gut syndrome, alleviating the intestinal and systemic effects of chronic alcohol consumption, including intestinal dysbiosis, and/or reducing inflammation, including intestinal-derived or intestinal-associated inflammation, comprising administering an effective amount of an immunogenic probiotic composition comprising an isolated first Lactobacillus reuteri strain and an isolated second Lactobacillus reuteri strain wherein: the nucleic acid set forth in SEQ ID NOs: 49 and 44, or Lactobacillus reuteri ATCC strain PTA-126788 and Lactobacillus reuteri ATCC strain PTA-1267887.
The closest prior art:
Kumar et al (WO 2020/163398 A1) discloses a composition for use in reducing intestinal permeability or leaky gut and reducing inflammation, including intestinal-derived or intestinal-associated inflammation when an effective amount is administered to an animal, as compared to an animal not administered the composition, and wherein the composition comprises at least one of an isolated first Lactobacillus reuteri strain and an isolated second Lactobacillus reuteri strain (pg 2, In 10-13 "invention provides a composition having at least one of an isolated first Lactobacillus reuteri strain and an isolated second Lactobacillus reuteri strain, wherein said composition increases animal health when an effective amount is administered to an animal, as compared to an animal not administered the composition. In one embodiment, the first isolated first lactobacillus reuteri strain includes at least one of: a nucleic acid sequence and a nucleic acid that encodes for an amino acid sequence"; pg 7, In 13-16 - "Positive health benefits include decreasing feed conversion ratio, increasing weight, increasing lean body mass, decreasing pathogen-associated lesion formation in the gastrointestinal tract, decreasing colonization of pathogens, reducing inflammation, and decreasing mortality rate."; pg 5, In 22-27 "In one embodiment, the isolated first Lactobacillus reuteri strain is strain 3632. In one embodiment, the isolated second Lactobacillus reuteri strain is strain 3630."). Elanco does not disclose where the isolated first Lactobacillus reuteri strain has a genomic nucleic acid sequence including SEQ ID NOs: 49, and the isolated second Lactobacillus reuteri strain has a genomic nucleic acid sequence including SEQ ID NOs: 44.
Genbank Accession No. CP002844 "Lactobacillus reuteri SD2112, complete genome" (hereinafter 'CP002844') discloses a sequence comprising a sequence with 100% identity to residues 1086173-1087183 of SEQ ID NO: 49 and residues 720040-721050 of SEQ ID NO: 44, and a sequence with 99.3% identity to residues 1661964-1662263 of SEQ ID NO: 49 and 99.3% identity to residues 1298022- 1298321 of SEQ ID NO: 44 (CP002844 sequence residues 1050916-1051926 have 100% identity to residues 1086173-1087183 of SEQ ID NO: 49 and residues 720040-721050 of SEQ ID NO: 44 (as represented by instant applicant SEQ ID NO: 59 [see para [00217], [000254] of the instant application]; Note, SEQ ID NOs: 59 and 68 of the instant application are identical), and CP002844 sequence residues 1626386-1626684 have 99.3% identity to residues 1661964-1662263 of SEQ ID NO: 49 and residues 1298022-1298321 of SEQ ID NO: 44 (as represented by instant applicant SEQ ID NO: 11 [see Sequence Listing of the instant application]). CP002844 does not disclose a composition comprising an isolated first Lactobacillus reuteri strain with a genomic nucleic acid sequence including SEQ ID NOs: 49 and an isolated second Lactobacillus reuteri strain with a genomic nucleic acid sequence including SEQ ID NOs: 44.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 6/25/26
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