Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group 1 (a synthetic formulation comprising one or more B. longum transitional clade microorganisms, B. longum microorganisms per se, and a combination and synthetic composition comprising the B. longum microorganisms) in the reply filed on 9 Feb 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 12-23 and 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 Feb 2026.
Claim Status
The amended claim set filed 9 Feb 2026 is acknowledged. Claims 1, 4-29, and 32-33 are currently pending. Of those, claims 1, 4-8, 10-11, 14, 17-18, 21-23, and 26-29 have been amended relative to the original claims and no claims are new. Claims 12-23 and 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 Feb 2026. Claims 2-3 and 30-31 are cancelled. Claims 1, 4-11, and 24-29 will be examined on the merits herein.
Priority
The instant application claims priority to provisional application 63/216,127 (filed 29 June 2021) and is a 371 of PCT/US2022/035310 (filed 28 June 2022). The effective filing date used for searching the art is 29 June 2021 for all claims.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 28 Dec 2023, 2 Aug 2024, 9 Feb 2026, 5 May 2026, and 8 May 2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action. For the IDS filed 28 Dec 2023, the NPL#2 reference (Bunesova et al.) was not provided, but a copy is attached with this action.
Drawings
The drawings are objected to because:
In Figures 7A-D, there are two different keys for each figure (depicting true/false and gene CPM) and because the gene CPM key cannot be interpreted in a black-and-white format because the darkness of the color does not change in a consistent direction (lightest colors are in two different parts of the key).
In Figure 8, the text references “red” but the drawings were submitted in black-and-white.
In Figures 20-21, there are two different keys for each figure (depicting true/false and clade).
In Figure 23, the different time points have colors that are too similar in darkness and that cannot be interpreted in a black-and-white format.
In Figure 26, there are two different keys for each figure (depicting true/false and genome).
In Figures 30 and 34, the key cannot be interpreted in a black-and-white format because the darkness of the color does not change in a consistent direction (both high and low are darker).
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Specification
The disclosure is objected to because of the following informalities: Appropriate correction is required.
The specification at [291] reads “FIG. 38 shows Average Nucleotide Identity (ANI) UPGMA based phylogenetic tree.” This is inconsistent with the description of the drawing at [0071] and the figure itself.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Specifically, hyperlinks are found at [0004], [0179], [0289] and [0293]. The required amendment is for the prefix such as http:// to be deleted, the remainder of the website name can remain.
Claim Objections
Claims 1 and 25 are objected to because of the following informalities: the claims are incomplete because they reference tables from the specification. See MPEP 2173.05(s): “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” Appropriate correction is required.
Claim 27 is objected to because of the following informalities: typographical error. The claim reads “isolated from human” but should read “isolated from a human” to match the phrasing in claim 5. Appropriate correction is required.
Claim Interpretation
Regarding claims 6, 8-9, and 28-29, the specification defines “As used herein, the expressions “fiber” or “fibers” or “dietary fiber” or “dietary fibers” within the context of the present invention indicate the indigestible portion, in small intestine, of food derived from plants which comprises two main components: soluble fiber, which dissolves in water and insoluble fiber.” [0171]. Therefore, the claims to prebiotic fiber do not include human milk oligosaccharides, because they are not derived from plants, although they are known to the art to both have prebiotic activity and be indigestible (Frese, US 20210161924 A1; PTO-892; [0002-0003]).
Claim Rejections - 35 USC § 112(b)
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, 4-11, and 24-29 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.
Regarding claims 1 and 24, the claims each recite “Bifidobacterium longum (B. longum) transitional clade microorganisms which has at least 98.6 % Average Nucleotide Identity (ANI) with at least one strain selected in the group consisting of: CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687”. The reference to microorganisms with at least a certain ANI, without a clear genome sequence to compare to, is a relative term which renders the claim indefinite. The genome sequences of the five references strains are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the response to the rule 105 communication requesting the genome sequences of the five reference strains, applicant stated (Remarks filed 5 May 2026): “The genome sequences are accessible via the Joint Genome Institute (JGI) (https://genome.jgi.doe.gov/portal/). Individual JGI project numbers are provided in Table 6 of the specification: CNCM I-5683 (NCC 5000): Ga0527908; CNCM I-5684 (NCC 5001): Ga0529016; CNCM I-5685 (NCC 5002): Ga0529017; CNCM I-5686 (NCC 5003): Ga0529018; and CNCM I- 5687 (NCC 5004): Ga0529019. Search the NCC # (e.g. 5000, 5001, 5002, 5004, 5004) at the aforementioned web site and it will take you to a link where the genomic sequence can be downloaded.”
First, the reference to the genome sequences is indefinite because following the directions leads to a link where many different files can be downloaded (44 different files for NCC 5000, see screenshots below), and it is not apparent which file contains the genome sequence that should be used for comparison.
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Second, the reference to the genome sequences is indefinite because the information is not actually part of the application as filed. The external site is not a sufficiently clear record for the purposes of definiteness because the site may be updated over time. For example, the release date of the current genome for NCC 5000 is 07 Nov 2022, which is after the 371 application that the instant application claims priority to was filed. One of ordinary skill in the art cannot clearly determine which microorganisms have at least 98.6% ANI compared to reference genomes that can change over time.
Third, applicant is directed to the incorporation by reference requirements, which require that “essential material”, such as material that is necessary to describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b), must be derived from a US patent or patent application publication, and may not be derived from non-patent publications such as the cited website. See MPEP 608.01(p).I. and 37 CFR 1.57.
For all these reasons, one of ordinary skill in the art at the time of filing would not be able to clearly determine which microorganisms fall within the scope of the relative term “microorganisms which has at least 98.6 % Average Nucleotide Identity (ANI) with at least one strain selected in the group consisting of: CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687”. Claims 1 and 24 are indefinite, and dependent claims 4-11 and 26-29 are also indefinite because they depend from these claims and do not obviate the grounds of rejection.
Regarding claims 1, 4-5, the claims each recite “Bifidobacterium longum transitional clade”. The term “transitional clade” is a relative term which renders the claim indefinite. The instant specification does not define the term “transitional clade”, and the term does not have a well-understood definition in the art at the time of filing. Without a clear definition, one of ordinary skill would be unable to determine both what transition(s) are claimed, and how the clade is defined in relation to the transition(s). Notably, the art defines many different Bifidobacterium transitions that occur during a person’s life, in addition to the transition at weaning that was considered in the specification’s examples. Makino et al. (2013; PTO-892) teaches transitions after birth when the early infant is first colonized with bifidobacteria (Abstract), and Luan et al. (2020; PTO-892) teaches transitions in Bifidobacterium longum as a subject transitions towards death (Abstract). As a result, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention because they would not be able to determine whether or not a B. longum strain that meets the gene and/or genome requirements of the claims is part of the transitional clade. Claims 1 and 4-5 are indefinite, and dependent claims 4-11 are also indefinite because they depend from at least one of these claims and do not obviate the grounds of rejection. In the interest of compact prosecution, in this action, all B. longum strains that meet the other requirements of claim 1 (a)-(d), 4, and/or 5 will also be interpreted as being transitional clade.
Regarding claims 1 and 25, the claims each recite “genes from Table 1” and/or “genes from Table 2”. However, these tables contain “gene clusters” with multiple different “locus tags” rather than listing genes (i.e. nucleic acid sequences that are disclosed in the specification or well-known in the art at the time of filing). The specification also does not define what sequences correspond to the locus tags. One of ordinary skill in the art would not be able to determine what genes must be present in the claimed microorganisms because the description in the claim does not correspond with the table in the specification. Claims 1 and 25 are indefinite, and dependent claims 4-11 are also indefinite because they depend from at least one of these claims and do not obviate the grounds of rejection.
Regarding claim 7, the claim recites “wherein the fat source is a milk derived fat source or equivalent thereof, wherein the protein source is a milk derived protein source or equivalent thereof, and/or wherein the carbohydrate source is a milk derived carbohydrate source or equivalent thereof.” In the claim context, the term “equivalent” functions similar to stating “or the like”. The phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). One of ordinary skill in the art at the time of filing would not be apprised of the scope of the claim because it's not apparent what features should be used to determine the equivalence (e.g. equivalent for human nutrition, equivalent for bacterial nutrition, the same molecule but from non-milk sources, etc.?) In the interest of compact prosecution, in this action the equivalence will be explained at each use.
Regarding claim 9, the term “associated with” is a relative term which renders the claim indefinite. The term “associated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As a result, one of ordinary skill in the art at the time of filing would not be able to determine what types and degrees of association are required. In the interest of compact prosecution, in this action the limitation will be interpreted with the broadest reasonable interpretation that being in the same composition meets the “associated with” limitation because the two components would be administered together (i.e. in association with each other).
Regarding claim 11, the claim recites “wherein the synthetic formulation is adapted for infant and/or young child use.” MPEP 2173.05(g) states: “Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.” In this situation, (1) there is not a clear cut indication of the scope of the subject matter covered by the claim because the specification does not define what structural features make a formulation “adapted to” use by infants and/or young children and the term also does not have a clear, unambiguous definition in the art at the time of filing. (2) The claim does not set forth well-defined boundaries and instead only recites an intended use that is the result obtained. (3) As a result, one of ordinary skill in the art at the time of filing would not be able to clearly determine what ingredients, concentrations, forms (such as solid vs. liquid formulation), etc. fall within the claimed scope based on the specification and art at the time of filing. Therefore, the claim is indefinite. In the interest of compact prosecution, in this action the limitation will be interpreted as being met unless the reference specifically teaches not to administer it to infants and young children.
Regarding claim 25, the claim recites “A Bifidobacterium longum (B. longum) microorganism as in claim 25, wherein the B. longum microorganism is characterized by the presence of all genes from Table 1.” The claim is indefinite because it depends from itself, so one of ordinary skill in the art at the time of filing would not be able to clearly determine which properties (if any) are required other than the presence of all genes from Table 1. In the interest of compact prosecution, in this action the claim will be interpreted as only requiring a B. longum microorganism characterized by the presence of all genes from Table 1.
Claim Rejections - 35 USC § 112(a)
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 1-11 and 24-29 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.
Claims 1-11 and 24-29 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 (c) one or more Bifidobacterium longum (B. longum) transitional clade microorganisms characterized by the presence of all genes from Table 2, if the genes were clearly described, which includes the isolates CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687, does not reasonably provide enablement for (a) one or more Bifidobacterium longum (B. longum) transitional clade microorganisms which has at least 98.6 % Average Nucleotide Identity (ANI) with at least one strain selected in the group consisting of: CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687, in the absence of genome sequences for the CNCM species to use for comparison, or (b) one or more Bifidobacterium longum (B. longum) transitional clade microorganisms characterized by the presence of all genes from Table 1. 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 the invention commensurate in scope with these claims.
The breadth of the claims: Claim 25 is narrow and requires a B. longum microorganism wherein the B. longum microorganism is characterized by the presence of all genes from Table 1. Claim 24 (and dependent claims) is less narrow and requires a Bifidobacterium longum (B. longum) microorganism characterized by at least 98.6% Average Nucleotide identity (ANI) with at least one strain selected in the group consisting of: CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687, and combinations thereof. Claim 1 (and dependent claims) is broader and requires a synthetic formulation comprising:(a) one or more Bifidobacterium longum (B. longum) transitional clade microorganisms which has at least 98.6 % Average Nucleotide Identity (ANI) with at least one strain selected in the group consisting of: CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687; or (b) one or more Bifidobacterium longum (B. longum) transitional clade microorganisms characterized by the presence of all genes from Table 1; or (c) one or more Bifidobacterium longum (B. longum) transitional clade microorganisms characterized by the presence of all genes from Table 2; or (d) a combination of (a) and (b), or a combination of (a) and (c), or a combination of (b) and (c).
The nature of the invention: The invention is a specific microorganism comprising all the genes in Table 1 on pg. 65-77 of the specification, Table 2 on pg. 77-83 of the specifications, or compositions comprising it. The invention is also a specific microorganism with a genome that is defined in relation to certain isolates.
The state of the prior art: It is not apparent that there were strains known in the art at the time of filing that comprise all the genes/ gene clusters of Table 1-2, and the isolates CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687 did not have genome sequences available to one of ordinary skill in the art at the time of filing for comparison. Bunesova et al. (2016; hereafter Bunesova; PTO-892) teaches the isolate Bifidobacterium longum subsp. suis BSM11-5 (Abstract) and its presence in synthetic formulations that are different growth media (pg. 3 col. 2 sections “Growth conditions” and “Utilization of selected sugars and metabolite formation” for description of different formulations). The instant specification provides evidence that this isolate is part of the “newly described” “well defined clade” and has approximately 99% ANI with the claimed CNCM strains (listed in Figure 39 using their NCC numbers) [0290, Figure 36]. However, Bunesova does not teach whether the Bifidobacterium longum subsp. suis BSM11-5 isolate has all the genes/ gene clusters of Tables 1-2.
The level of one of ordinary skill: The level is relatively high, but predicting the genome of a bacteria before it has been isolated is beyond the level of ordinary skill.
The level of predictability in the art: The level of predictability for the genome of a bacteria before it has been isolated and sequenced is low.
The amount of direction provided by the inventor: The inventor does not identify how to isolate a bacteria characterized by the presence of all genes from Table 1. However, Table 2 is a list of genes that are present in all 5 CNCM isolates [0286], so the CNCM isolates are examples within the claimed group.
The existence of working examples: The instant specification analyzed nine reference genomes [0285]. These nine isolates include five NCC isolates that were isolated from feces of breast-fed infants [0289]. Table 1 does not disclose that any of the nine strains have all genes listed in Table 1. For example, no strains are disclosed as having all three of these genes (note the non-overlapping list of genomes with the gene/ gene cluster):
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Table 2 is a list of genes that are present in all 5 CNCM isolates [0286], so the CNCM isolates are examples within the claimed group.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: It is apparent that a B. longum microorganism as characterized by the presence of all genes from Tables 1-2, or the CNCM isolates, is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of a strain with these properties.
The specification does not describe a process to obtain a microorganism comprising all genes from Table 1. Instead, it describes a process to obtain microorganisms that have some but not all of the genes from Table 1. The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public.
Also, the specification does not describe a process to obtain a microorganism that has at least 98.6 % Average Nucleotide Identity (ANI) with at least one CNCM strain, because one of ordinary skill in the art cannot determine whether this limitation is met without having access to either the CNCM genome sequences or the strains themselves. Neither the genome nor the strains were known and readily available to the public at the time of filing. It is noted that Applicants have deposited biological material but there is no indication in the specification as to public availability.
As the claim is drawn to a bacteria itself, one cannot make or use the claimed bacteria without access to the bacteria. In the absence of a deposit, one of ordinary skill in the art must isolate bacteria at random, with no expectation of successfully obtaining a strain with all the genes/ gene clusters of Table 1 and no way to determine whether the strain has at least 98.6% ANI with the claimed reference strains. It is noted that all five of the strains isolated by the specification lack at least one of the genes/ gene clusters of Table 1. Therefore, the deposit of the CNCM strains would not enable selecting a strain with all the genes/ gene clusters of Table 1.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
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, 4-11, and 24-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Regarding claims 1 and 4-5, claim 1 recites a synthetic formulation comprising: (a) one or more Bifidobacterium longum (B. longum) transitional clade microorganisms which has at least 98.6 % Average Nucleotide Identity (ANI) with at least one strain selected in the group consisting of: CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687; or (b) one or more Bifidobacterium longum (B. longum) transitional clade microorganisms characterized by the presence of all genes from Table 1; or (c) one or more Bifidobacterium longum (B. longum) transitional clade microorganisms characterized by the presence of all genes from Table 2; or (d) a combination of (a) and (b), or a combination of (a) and (c), or a combination of (b) and (c). The instant specification defines at [0124] that “The expression “synthetic composition” means a mixture obtained by chemical and/or biological methods and techniques. In some embodiments, the synthetic composition which can biologically, nutritionally, and/or chemically equivalent or identical to the mixture naturally occurring in mammalian milks or a component thereof…” (emphasis added). Dependent claims 4-5 limit the microorganisms present. Dependent claim 5 specifically states that the microorganisms can be isolated from a natural source (a human). (Step 1: yes, a product)
The only claimed component of the synthetic formulation of claims 1 and 4-5 is a natural bacteria, and the specification admits that a synthetic composition might be identical to a naturally occurring mixture. Additionally, the Supreme Court made clear in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013)) that incidental changes that may occur during isolation of a natural product are not necessarily enough to make the isolated product markedly different, see MPEP 2106.04(c).II.C.2. Neither the claims nor specification teach any properties that have changed about the bacteria as a result of isolation to a synthetic formulation. Therefore, the synthetic formulation lacks markedly different properties to a natural product and is a product of nature exception. (Step 2A Prong 1: yes, recites a natural phenomenon).
This judicial exception is not integrated into a practical application because there are no additional elements of the claim other than the natural product. (Step 2A Prong 2: no additional elements). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements of the claim other than the natural product. (Step 2B: not significantly more).
Regarding claims 6-7, and 10-11, these claims depend from claim 1 and recite additional natural products that are present in the synthetic formulation (a fat source, a protein source, a carbohydrate source, a dietary fiber source, or a combination thereof, or more detailed versions of these). These components are present in mammalian milk, and the specification states at [0124] that this is a naturally occurring mixture. Dependent claim 10 recites the synthetic formulation can be a milk fortifier. The specification defines at [0181] that “As used herein, “fortifier” refers to liquid, semi-solid, or solid nutritional compositions suitable for mixing with breast milk or infant formula”. Dependent claim 11 recites the synthetic formulation is adapted for infant and/or young child use. Both of these claims require nothing more than bacteria in milk, which the specification states is a naturally occurring mixture [0124] and which is a liquid composition suitable for mixing in milk or formula and that is capable of being administered to an infant or young child. MPEP 2106.04(c).I.A states: “Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately.” In these claims, the combination of milk and Bifidobacterium is a naturally occurring mixture.
Additionally, the Supreme Court made clear in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013)) that incidental changes that may occur during isolation of a natural product are not necessarily enough to make the isolated product markedly different, see MPEP 2106.04(c).II.C.2. Neither the claims nor specification teach any properties that have changed about the bacteria or milk as a result of isolation to a synthetic formulation. Similarly, there are no disclosed changes to the bacteria being associated with fiber. Therefore, the synthetic formulation (bacteria and milk) lacks markedly different properties to a natural product and is a product of nature exception. (Step 2A Prong 1: yes, recites a natural phenomenon).
This judicial exception is not integrated into a practical application because there are no additional elements of the claim other than the natural product. (Step 2A Prong 2: no additional elements). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements of the claim other than the natural product. (Step 2B: not significantly more).
Regarding claims 8-9, the claims are drawn to a combination of microorganisms of claim 1 and dietary fibers. MPEP 2106.04(c).I.A states: “Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately.” In these claims, both components are individually natural products, and the combination is not disclosed to have any markedly different characteristics compared to the individual components. Therefore, the combination lacks markedly different properties to a natural product and is a product of nature exception. (Step 2A Prong 1: yes, recites a natural phenomenon).
This judicial exception is not integrated into a practical application because there are no additional elements of the claim other than the natural product. (Step 2A Prong 2: no additional elements). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements of the claim other than the natural product. (Step 2B: not significantly more).
Regarding claims 24-27 and 29, the claims are drawn to B. longum microorganisms that can be isolated from a human (see claim 27) and a composition comprising the bacteria but no other required elements. For claim 25, all genes are found in B. longum microorganisms naturally, and there are no disclosed properties that make the bacteria markedly different when all genes are combined. As above for claim 1, the bacteria are natural products (Step 2A Prong 1: yes, recites a natural phenomenon).
This judicial exception is not integrated into a practical application because there are no additional elements of the claim other than the natural product. (Step 2A Prong 2: no additional elements). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements of the claim other than the natural product. (Step 2B: not significantly more).
Regarding claim 28, the claims are drawn to a combination of microorganisms of claim 24, milk-derived carbohydrates, and dietary fibers. MPEP 2106.04(c).I.A states: “Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately.” In these claims, all components are individually natural products, and the combination is not disclosed to have any markedly different characteristics compared to the individual components. Therefore, the combination lacks markedly different properties to a natural product and is a product of nature exception. (Step 2A Prong 1: yes, recites a natural phenomenon).
This judicial exception is not integrated into a practical application because there are no additional elements of the claim other than the natural product. (Step 2A Prong 2: no additional elements). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements of the claim other than the natural product. (Step 2B: not significantly more).
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.
Claims 1, 4-7, 10-11, 24-27, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bunesova et al. (2016; hereafter Bunesova; PTO-892).
Regarding claims 1, 24, 29, Bunesova teaches the isolate Bifidobacterium longum subsp. suis BSM11-5 (Abstract) and its presence in synthetic formulations that are different growth media (pg. 3 col. 2 sections “Growth conditions” and “Utilization of selected sugars and metabolite formation” for description of different formulations). The instant specification provides evidence that this isolate is part of the “newly described” clade and has approximately 99% ANI with the claimed CNCM strains (listed in Figure 39 using their NCC numbers) [0290, Figure 36].
Regarding claims 4, 26, the isolate is Bifidobacterium longum subsp. suis and not of the subspecies B. longum subspecies longum or B. longum subspecies infantis (Abstract).
Regarding claims 5, 27, the isolate is isolated from a human, specifically Kenyan infant stool, 6 m old (Table 1 on pg. 3).
Regarding claims 6-7, 29, the media compositions for HMO utilization screening comprise carbohydrate supplemented API medium (2′-FL and 3′-FL: 4mM, 3′-SL and 6′-SL: 2mM, LNnt: 1mM; glucose: 6mM; lactose: 3mM) (pg. 3 col. 2 par. 3). 2′-FL and 3′-FL, 3′-SL and 6′-SL, and LNnt are abbreviations for human milk oligosaccharides (pg. 2 col. 1 par. 1) (i.e. milk derived carbohydrate source).
Regarding claim 10-11, the specification defines at [0181] that “As used herein, “fortifier” refers to liquid, semi-solid, or solid nutritional compositions suitable for mixing with breast milk or infant formula”. The bacteria and media composition of Bunesova is suitable for mixing with milk or formula, and is adapted for infant and/or young child use because there is no indication that the composition cannot be used for this purpose.
Regarding claim 25, Bunesova is silent on the genes/ gene clusters that are present in isolate Bifidobacterium longum subsp. suis BSM11-5. However, this bacteria is presumed to have the claimed genes, absent evidence to the contrary, because it is substantially identical to the disclosed isolates from the instant specification due to its high degree of genetic relatedness and due to both the BSM11-5 isolate and the disclosed isolates being isolated from infant feces (Bunesova Table 1 on pg. 3, instant [0289]). See MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 4-11, and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Bunesova et al. (2016; hereafter Bunesova; PTO-892) in view of Stanton et al. (US 20200345051 A1; hereafter Stanton; PTO-892).
The teachings of Bunesova were discussed above and include all elements of claims 1, 4-7, 10-11, 24-27, and 29. Regarding claim 28, Bunesova teaches a combination of microorganisms described in claim 24 and milk derived carbohydrates, as discussed above for claims 6-7 and 29.
Bunesova does not teach the synthetic formulation further comprises a dietary fiber source that is a prebiotic fiber, as in claim 8, or the one or more B. longum microorganisms are associated with the prebiotic fiber, as in claim 9. Bunesova does not teach a combination comprising dietary fibers, as in claim 28 and as optionally present in claim 29.
Stanton teaches compositions comprising cohorts of bacteria [Abstract] and teaches that the composition can include B. longum species from human infant intestinal origin [0022-0023] and can include B. longum subsp. suis [Table 1]. Stanton also teaches that the compositions can include prebiotic compositions such as dietary fibers, which have the benefit of promoting the growth of probiotic microbes or bacteria, especially bacterial growth in the mammalian gastrointestinal tract [0119].
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Bunesova bacteria and carbohydrate composition by adding prebiotic fiber as taught in Stanton, thereby arriving at the claimed invention, because Stanton teaches the fiber has the benefit of promoting the growth of probiotic B. longum species from human infant intestinal origin, especially bacterial growth in the mammalian gastrointestinal tract. Therefore the combination would be desirable because it would improve bacterial growth and survival. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” The modification can be performed with a reasonable expectation of success because it only requires mixing known ingredients and because Stanton already teaches that prebiotic fibers can be used with B. longum bacteria including B. longum subsp. suis.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. a composition comprising Bifidobacterium longum subsp. suis BSM11-5 and milk-derived carbohydrates from Bunesova, prebiotic dietary fiber that has growth benefits when mixed with B. longum subsp. suis from Stanton) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-11, and 24-29 and provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 8-9, 11-12, 18, and 20-23 of copending Application No. 18/577,141 (reference application), either alone or in view of Stanton et al. (US 20200345051 A1; hereafter Stanton; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, 24, 29, ‘141 claims 8, 9, and 18 (and dependent claims) teach a composition comprising a Bifidobacterium longum transitional microorganism, … wherein the Bifidobacterium longum microorganism has an Average Nucleotide Identity (ANI) of at least 96% with at least one Bifidobacterium longum strain selected from the group consisting of CNCM I-5683, CNCM I- 5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687, and any combination thereof. This is also a disclosure that one can use the strains CNCM I-5683, CNCM I- 5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687.
Regarding claims 4-5, 26-27, the strains CNCM I-5683, CNCM I- 5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687 meet these limitations [instant Example 7, [0289-0290]]. MPEP 804 states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)”. In this case, the specification is being used to learn the meaning of the strain names.
Regarding claim 6-7, ‘141 claims 11-12 teach the composition can comprise the prebiotic oligosaccharides (i.e. a carbohydrate source) 2'-0-fucosyllactose (2FL), 3'-O-fucosyllactose (3FL), lactodifucotetraose/difucosyllactose (DFL), 3'-O-sialyllactose (3-SL), 6'-0- sialyllactose (6'-SL) and lacto-N-tetraose (LNT). The instant specification provides evidence that 2FL is naturally found in milks [0151], so it is a milk derived carbohydrate source or equivalent thereof. MPEP 804 states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)”. In this case, the specification is being used to learn the meaning of the chemical name.
Regarding claims 10-11, ‘141 claims 8-9 and 18 teach administering to an infant and/or young child. The composition is suitable for mixing with milk (“fortifier” definition at instant [0181]), absent evidence to the contrary.
Regarding claim 25, ‘141 claims teach a composition comprising Bifidobacterium longum transitional microorganisms. The claims of ‘141 are silent on the presence of genes in Table 1. However, this bacteria is presumed to have the claimed inherent properties, absent evidence to the contrary, because it is substantially identical to the disclosed isolates from the instant specification due to both strains being B. longum transitional microorganisms. See MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Claims 1, 4-7, 10-11, 24-27, and 29 are rejected over the claims of ‘141 alone.
The claims of ‘141 do not teach the synthetic formulation further comprises a dietary fiber source that is a prebiotic fiber, as in claim 8, or the one or more B. longum microorganisms are associated with the prebiotic fiber, as in claim 9. The claims of ‘141 do not teach a combination comprising dietary fibers, as in claim 28 and as optionally present in claim 29.
Stanton teaches compositions comprising cohorts of bacteria [Abstract] and teaches that the composition can include B. longum species from human infant intestinal origin [0022-0023] and can include B. longum subsp. suis [Table 1]. Stanton also teaches that the compositions can include prebiotic compositions such as dietary fibers, which have the benefit of promoting the growth of probiotic microbes or bacteria, especially bacterial growth in the mammalian gastrointestinal tract [0119].
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the ‘141 bacteria and carbohydrate composition by adding prebiotic fiber as taught in Stanton, thereby arriving at the claimed invention, because Stanton teaches the fiber has the benefit of promoting the growth of probiotic B. longum species from human infant intestinal origin, especially bacterial growth in the mammalian gastrointestinal tract. Therefore the combination would be desirable because it would improve bacterial growth and survival. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” The modification can be performed with a reasonable expectation of success because it only requires mixing known ingredients and because Stanton already teaches that prebiotic fibers can be used with B. longum bacteria including B. longum subsp. suis.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. a composition comprising Bifidobacterium longum subsp. suis CNCM isolate and milk-derived carbohydrates from ‘141, prebiotic dietary fiber that has growth benefits when mixed with B. longum subsp. suis from Stanton) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1, 4-11, and 24-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-9 and 13-15 of copending Application No. 18/840,767. This is a provisional nonstatutory double patenting rejection.
Regarding claims 1, 24, 29, ‘767 claims 9 (and dependent claims) teach a composition comprising a B. longum transitional microorganism and one or more glycan substrates from the groups recited in Tables 1-3. ‘767 claim 8 (and dependent claims) teaches the glycan substrates promote the growth of B. longum transitional microorganisms, and ‘767 claim 14 teaches the B. longum microorganism can have an Average Nucleotide Identity (ANI) of at least 98% with at least one Bifidobacterium longum strain selected in the group consisting of CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687, and any combination thereof. This is also a disclosure that one can use the strains CNCM I-5683, CNCM I- 5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687.
Regarding claims 4-5, 26-27, the strains CNCM I-5683, CNCM I- 5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687 meet these limitations [instant Example 7, [0289-0290]]. MPEP 804 states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)”. In this case, the specification is being used to learn the meaning of the strain names.
Regarding claims 6-9, and 28-29, the glycans of Table 1 of ‘767 include dietary fiber from plants (i.e. prebiotic fiber). The glycans of Table 2 also include human milk oligosaccharides (i.e. milk derived carbohydrate source). MPEP 804 states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” In this case, the specification is being used to understand the meaning of the Tables.
Regarding claims 10-11, ‘767 claims 8-9 teach administering to an infant and/or young child.
Regarding claim 25, ‘767 claims teach a composition comprising Bifidobacterium longum transitional microorganisms. The claims of ‘767 are silent on the presence of genes in Table 1. However, this bacteria is presumed to have the claimed inherent properties, absent evidence to the contrary, because it is substantially identical to the disclosed isolates from the instant specification due to both strains being B. longum transitional microorganisms. See MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Claims 1, 4-6, 8-11, and 24-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/487,594. This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, 24-25, 29, ‘594 claims 1-3 (and dependent claims) teach B. longum transitional microorganisms and claim 10-11 (and dependent claims) teach compositions comprising them. The claims of ‘594 are silent on the % ANI relative to at least one strain selected in the group consisting of: CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687 and the presence of genes in Tables 1-2. However, this bacteria is presumed to have the claimed inherent properties, absent evidence to the contrary, because it is substantially identical to the disclosed isolates from the instant specification due to both strains being B. longum transitional microorganisms. See MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Regarding claims 4-5, 26-27, ‘594 claims teach that the B. longum transitional microorganisms can be CNCM I-5942. The ‘594 specification teaches that this isolate is also called NCC 5025 and was isolated from “the feces of a weaning infant aged (between 6 to 12 months old).” (pg. 48) and that the isolate is “B. longum juvenis” (pg. 53) so it is not of the subspecies B. longum subspecies longum or B. longum subspecies infantis. MPEP 804 states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” In this case, the ‘594 specification is used as a dictionary to learn the meaning of the CNCM strain found in the claims.
Regarding claim 6, 8-9, 28-29, ‘594 claims 11-12 (and dependent claims) teach compositions comprising the strain can further comprise dietary fiber and prebiotics.
Regarding claims 10-11, ‘594 claim 14 teaches administering the strain to an infant or young child. The composition is suitable for mixing with milk (“fortifier” definition at instant [0181]), absent evidence to the contrary.
Claims 1, 4-11, and 24-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/522,423 either alone or in view of Stanton et al. (US 20200345051 A1; hereafter Stanton; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, 24, 29, ‘423 claim 1, 11-12, 14-15 (and dependent claims) teach a composition comprising a B. longum transitional microorganism. ‘423 claim 3 teaches the B. longum transitional microorganism can have an Average Nucleotide Identity (ANI) of at least 98% with at least one Bifidobacterium longum strain selected from the group consisting of CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686, and CNCM I-5687. This is also a disclosure that one can use the strains CNCM I-5683, CNCM I- 5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687.
Regarding claims 4-5, 26-27, the strains CNCM I-5683, CNCM I- 5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687 meet these limitations [instant Example 7, [0289-0290]]. MPEP 804 states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)”. In this case, the specification is being used to learn the meaning of the strain names.
Regarding claims 6-7, 28, ‘423 claim 1, 11-12, 14-15 (and dependent claims) teach the composition comprises human milk oligosaccharides (i.e. milk derived carbohydrates).
Regarding claims 10-11, ‘423 claim 10 teaches the composition can be an infant formula (i.e. adapted for infant use, milk replacement) or a fortifier, and ‘423 claim 18 teaches the composition can be administered to an infant.
Regarding claim 25, ‘423 claims teach a composition comprising Bifidobacterium longum transitional microorganisms. The claims of ‘423 are silent on the presence of genes in Table 1. However, this bacteria is presumed to have the claimed inherent properties, absent evidence to the contrary, because it is substantially identical to the disclosed isolates from the instant specification due to both strains being B. longum transitional microorganisms. See MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Claims 1, 4-7, 10-11, 24-27, and 29 are rejected over the claims of ‘141 alone.
Like in the rejection over ‘141 above, the claims of ‘423 do not teach the synthetic formulation further comprises a dietary fiber source that is a prebiotic fiber, as in claim 8, or the one or more B. longum microorganisms are associated with the prebiotic fiber, as in claim 9. The claims of ‘423 do not teach a combination comprising dietary fibers, as in claim 28 and as optionally present in claim 29. The teachings of Stanton and the reason for combining are the same as disclosed above in the rejection over ‘141.
Claims 1, 6-11, and 24-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7- of copending Application No. 19/604,398 either alone or in view of Stanton et al. (US 20200345051 A1; hereafter Stanton; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, 24, 29, ‘398 claims 1-2, 13-14 (and dependent claims) teach administering a composition comprising a B. longum transitional microorganism.
Regarding claims 6-7, 28-29, ‘298 claims 5, 8-10 teaches the microorganism can be administered with a prebiotic that is a human milk oligosaccharide (i.e. milk derived carbohydrates).
Regarding claims 6, 8-9, 28-29, ‘298 claim 5 teaches the microorganism can be administered with a prebiotic that is a glycan substrate. ‘298 claim 7 teaches that the glycan substrate can be those in Tables 1-3. The glycans of Table 1 of ‘298 include dietary fiber from plants (i.e. prebiotic fiber). MPEP 804 states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)” In this case, the ‘298 specification is used as a dictionary to learn the meaning of the Table found in the claims.
Regarding claims 10-11, ‘298 claims 1-2, 13-14 (and dependent claims) teaches administering the strain to an infant or young child.
Conclusion
No claims are allowed.
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AMELIA N DICKENS
Examiner
Art Unit 1645
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
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