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 .
Claim Status
The amended claim set filed 4 May 2026 is acknowledged. Claims 16, 18, 20-21, and 23-38 are currently pending. Of those, claims 16, 18, 20-21 are currently amended, and claims 36-37 are new. Claims 28-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 20 Nov 2025. Claims 1-15, 17, 19, and 22 are cancelled. Claims 16, 18, 20-21, 23-27, and 36-38 will be examined on the merits herein.
References to paragraph numbers herein use the paragraph numbers from the pre-grant publication US20240041949A1.
Response to Arguments
The Applicants’ arguments filed 4 May 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 3 Feb 2026 will be referred to as “NFOA.”
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 April 2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. A signed copy of the statement is attached with this action.
Objection(s) and Rejection(s) Withdrawn
The objection to the drawings is withdrawn in view of the drawings filed 4 May 2026.
The rejection of claims 20-22 under 35 U.S.C. 112(b) (NFOA par. 13) is withdrawn in view of the claim amendments.
The rejection of claims 16-27 under 35 U.S.C. 112(a) (NFOA par. 19-22) is withdrawn in view of the claim amendments and arguments.
The rejection of claims 16-27 under 35 U.S.C. 102(a)(1) as being anticipated by Kouya et al. (NFOA par. 23-30) is withdrawn in view of the claim amendment “wherein the content of the bacterium of the genus Acidipropionibacterium acidipropionici or the processed product thereof in the composition is 10 to 40 mass% on a dry-weight basis” and related arguments.
Specification
The amendment filed 4 May 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “A low-FODMAP diet is described and defined in Gearry R. B et al., JCC, Vol. 3, pg. 8-14. (Year: 2009)In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971).” However, applicant has not explained why one of ordinary skill in the art would recognize this modification as the appropriate correction, particularly because this reference does not describe the low-FODMAP diet that is used in the study; instead, Gearry et al. points to another reference to describe the dietary counselling methodology (ref. 9, see pg. 9 col. 2 par. 4) (see also NFOA par. 15).
Applicant is required to cancel the new matter in the reply to this Office Action.
The disclosure is objected to because of the following informalities: [0064] cites the reference “Gearry R. B et al., JCC, 2008, 09, 004, p 8 to 14”. This reference does not appear to exist. Appropriate correction is required. Please note the requirement to not introduce new matter into the specification, see MPEP 2163.07 for a discussion of amendments to the application that are supported in the original description.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claims 36-37 recite “FO12425 strain”, but the specification refers to “IFO12425” instead.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(b)
Claim 27 remains 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 claim 27, the claim recites “the composition is a low- FODMAP diet or low-FOLFAP diet.” First, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “diet” in the claim is used by the claim to refer to a single composition, presumably a food composition, that may or may not have other implied requirements, while the accepted meaning is “The food requirements of an organism. The foods that constitute the human diet should contain vitamins, mineral salts (see essential element), and dietary fibre as well as water, carbohydrates and fats (which provide energy), and proteins (required for growth and maintenance).” (Martin and Hines, 2008; PTO-892). The accepted meaning refers to all food collectively consumed by an organism, not to a specific composition or dish. The term is indefinite because the specification does not clearly redefine the term “diet”.
Second, the term “low-FODMAP” is insufficiently defined in the specification and art. The specification states “A low-FODMAP diet is described and defined in Gearry R. B et al., JCC, 2008, 09, 004, p 8 to 14. More specifically, a low-FODMAP diet contains glucose/100 g plus less than 0.15 g of fructose; or less than 3 g of fructose per diet, and less than 0.2 g of fructan per diet (excluding less than 0.3 g per diet of grains, nuts, and seeds) regardless of the content of glucose.” [0064]. However, the Examiner cannot identify any reference published by the first author Gearry et al. in a journal abbreviated JCC in 2008. The Examiner found the reference Gearry et al. (published Feb 2009; PTO-892) which was published in Journal of Crohn's and Colitis, Vol. 3, pg. 8-14, so it has a different year and volume number than disclosed in the specification. However, this reference does not describe the low-FODMAP diet that is used in the study; instead, Gearry et al. points to another reference to describe the dietary counselling methodology (ref. 9, see pg. 9 col. 2 par. 4). The reference pointed to by Gearry et al. is Shepherd and Gibson (2006; PTO-892). Shepherd and Gibson teach “arbitrary cutoff values for the fructose and fructan content of individual foods and were defined as: (a) foods that have naturally occurring free fructose in excess of glucose (>0.5 g/100 g); (b) a fructose load of more than 3 g in an average serving quantity of the food or beverage; and (c) substantial food sources of fructans (>0.5 g/serving).” (par. bridging pg. 1632-1633). The definition of Shepherd and Gibson has different cutoffs from the definition subsequently listed in the specification. The specification’s “more specific” definition is difficult to interpret (it is unclear what “glucose/100 g” means) but it has different numerical cutoffs and two alternative definitions (note the “or” in [0064]) rather than three different conditions that must all be present as in Shepherd and Gibson. Therefore, one of ordinary skill would not be able to interpret the term “low-FODMAP” because the reference used to define the term does not exist, a plausible intended reference does not actually define the diet as stated, and the “more specific” definition is difficult to interpret and differs from the art-recognized cutoffs so it is unclear whether this is a second limiting definition for the term low-FODMAP or only an example of a stricter low-FODMAP diet that could be followed.
Third, the term “low-FOLFAP” (and low-FODMAP, given the insufficient definition in the specification) is a relative term which renders the claim indefinite. The specification defines that “FOLFAP, which is the acronym of Fructose, Oligosaccharide, Lactose, Fructans and Polyols” [0006]. However, the term “low” 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. One of ordinary skill in the art would not be able to determine which compositions have sufficiently low levels of Fructose, Oligosaccharide, Lactose, Fructans and Polyols, and whether the level of these ingredients should be determined collectively or individually.
In the interest of compact prosecution, in this action the claim was examined using the definition of Shepherd and Gibson.
Response to Argument
Applicant argues (Remarks pg. 10) that “Applicant submits that these terms are well known in the art as also mentioned in paragraph [0005] of the specification. As stated in paragraph [0005], FODMAP derives from "Fermentable", "Oligosaccharides", "Disaccharides", "Monosaccharides", and "Polyols", as well as FOLFAP derives from "Fructose", "Oligosaccharides", "Lactose", "Fructans", and "Polyols".”
The argument has been carefully considered but is not found persuasive. The examiner agrees that the abbreviations FODMAP and FOLFAP are defined in the specification. This argument does not address the first issue, which is the definition of the term “diet” not being consistent with its use in the art at the time of filing and also not being re-defined by the specification. This argument does not address the second issue, which is the definition of “low-FODMAP diet” being unclear and inconsistent with the art at the time of filing. This argument does not address the third issue, which is the degree required by the relative term “low” in “low-FOLFAP” and “low-FODMAP” not being adequately defined.
New Rejection(s)
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 16, 18, 20-21, 23-27, and 36-38 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 claim 16, the claim recites “wherein a total content of a saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium in the composition is 0.1 to 5 mass% or less, or the composition further comprising at least one additive selected from the group consisting of a protein hydrolysate, a yeast extract, a meat extract and glucose.” The claim scope is indefinite because the alternatives presented are not parallel in scope. One alternative restricts the saccharide and the other alternative requires at least one additive but does not restrict the saccharide. Therefore, the claim is ambiguous with respect to the saccharide limitation, as it is unclear whether the limitation applies when the additive is present, and whether the additive may itself be a saccharide. The claim is made more ambiguous by the improper grammar of “wherein … the composition further comprising at least one additive…” Claims 18, 20-21, 23-27, and 36-38 are also rejected because they depend from claim 16 and do not obviate this grounds of rejection. In the interest of compact prosecution, in this action, the two alternatives will be treated as alternatives, so either “a total content of a saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium in the composition is 0.1 to 5 mass% or less” and no further additives, or else that “the composition further comprising at least one additive selected from the group consisting of a protein hydrolysate, a yeast extract, a meat extract and glucose” and the composition may comprise any amount of saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium, or both alternatives may be present.
Regarding claim 16, the claim recites “a bacterium of the genus Acidipropionibacterium acidipropionici”. The amendment narrows to a specific bacterial species, but still refers to it as a genus. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “genus” is used by the claim to mean “species,” while the accepted meaning is “genus.” The term is indefinite because the specification does not clearly redefine the term. Claims 18, 20-21, 23-27, and 36-38 are also rejected because they depend from claim 16 and do not obviate this grounds of rejection. In the interest of compact prosecution, the claim will be examined as referring to A. acidipropionici bacteria.
Regarding claims 36-37, the claims recite “FO12425 strain”, but the specification refers to “IFO12425” instead. The claim is indefinite because the typographical error renders the intended strain name unclear.
Regarding claim 38, the claim recites “the composition is a low- FODMAP diet or low-FOLFAP diet.” First, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “diet” in the claim is used by the claim to refer to a single composition, presumably a food composition, that may or may not have other implied requirements, while the accepted meaning is “The food requirements of an organism. The foods that constitute the human diet should contain vitamins, mineral salts (see essential element), and dietary fibre as well as water, carbohydrates and fats (which provide energy), and proteins (required for growth and maintenance).” (Martin and Hines, 2008; PTO-892). The accepted meaning refers to all food collectively consumed by an organism, not to a specific composition or dish. The term is indefinite because the specification does not clearly redefine the term “diet”.
Second, the term “low-FODMAP” is insufficiently defined in the specification and art. The specification states “A low-FODMAP diet is described and defined in Gearry R. B et al., JCC, 2008, 09, 004, p 8 to 14. More specifically, a low-FODMAP diet contains glucose/100 g plus less than 0.15 g of fructose; or less than 3 g of fructose per diet, and less than 0.2 g of fructan per diet (excluding less than 0.3 g per diet of grains, nuts, and seeds) regardless of the content of glucose.” [0064]. However, the Examiner cannot identify any reference published by the first author Gearry et al. in a journal abbreviated JCC in 2008. The Examiner found the reference Gearry et al. (published Feb 2009; PTO-892) which was published in Journal of Crohn's and Colitis, Vol. 3, pg. 8-14, so it has a different year and volume number than disclosed in the specification. However, this reference does not describe the low-FODMAP diet that is used in the study; instead, Gearry et al. points to another reference to describe the dietary counselling methodology (ref. 9, see pg. 9 col. 2 par. 4). The reference pointed to by Gearry et al. is Shepherd and Gibson (2006; PTO-892). Shepherd and Gibson teach “arbitrary cutoff values for the fructose and fructan content of individual foods and were defined as: (a) foods that have naturally occurring free fructose in excess of glucose (>0.5 g/100 g); (b) a fructose load of more than 3 g in an average serving quantity of the food or beverage; and (c) substantial food sources of fructans (>0.5 g/serving).” (par. bridging pg. 1632-1633). The definition of Shepherd and Gibson has different cutoffs from the definition subsequently listed in the specification. The specification’s “more specific” definition is difficult to interpret (it is unclear what “glucose/100 g” means) but it has different numerical cutoffs and two alternative definitions (note the “or” in [0064]) rather than three different conditions that must all be present as in Shepherd and Gibson. Therefore, one of ordinary skill would not be able to interpret the term “low-FODMAP” because the reference used to define the term does not exist, a plausible intended reference does not actually define the diet as stated, and the “more specific” definition is difficult to interpret and differs from the art-recognized cutoffs so it is unclear whether this is a second limiting definition for the term low-FODMAP or only an example of a stricter low-FODMAP diet that could be followed.
Third, the term “low-FOLFAP” (and low-FODMAP, given the insufficient definition in the specification) is a relative term which renders the claim indefinite. The specification defines that “FOLFAP, which is the acronym of Fructose, Oligosaccharide, Lactose, Fructans and Polyols” [0006]. However, the term “low” 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. One of ordinary skill in the art would not be able to determine which compositions have sufficiently low levels of Fructose, Oligosaccharide, Lactose, Fructans and Polyols, and whether the level of these ingredients should be determined collectively or individually.
In the interest of compact prosecution, in this action the claim was examined using the definition of Shepherd and Gibson.
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 16, 18, 20-21, 23-27, and 36-38 are newly 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 compositions comprising bacteria or supernatant, but does not reasonably provide enablement for compositions with bacteria or processed products at 10-40 mass% on a dry weight basis. 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 factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01. Although all factors were considered, the Wands factors that were most relevant for this decision are discussed in detail below.
The breadth of the claims: The claimed invention is a composition comprising Acidipropionibacterium acidipropionici bacteria or a processed product thereof, wherein the processed product is culture supernatant or a heat-processed product, a concentrate, a sterilized product, a liquefied product, a paste, a dried product or a diluted product thereof. The content of the bacterium of the genus Acidipropionibacterium acidipropionici or the processed product thereof in the composition is 10 to 40 mass% on a dry-weight basis. The claim also requires that the composition comprise other ingredients: “a total content of a saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium in the composition is 0.1 to 5 mass%, or the composition further comprising at least one additive selected from the group consisting of a protein hydrolysate, a yeast extract, a meat extract and glucose.” Dependent claims require additional elements that must be present in the composition. Claim 24 requires the composition be suitable for oral administration, claim 25 includes that the composition further comprise food, claim 26 includes that the composition further comprise prebiotic or symbiotic ingredients, and claims 27 and 38 requires that the composition be a diet (i.e. also comprises food).
The claims are overly narrow; the dry-weight mass% required is not consistent with what is enabled by the specification as discussed below.
The amount of direction provided by the inventor and the existence of working examples: The specification discusses dry-weight formulations at two locations. First, “according to a preferable embodiment of the present invention, the effective amount of a bacterium of the genus Acidipropionibacterium or a processed product thereof is preferably 0.01 to 10000 mg/body weight kg/day, more preferably 0.1 to 9000 mg/body weight kg/day, further preferably 1 to 6000 mg/body weight kg/day, and still further preferably 5 to 6000 mg/body weight kg/day, 10 to 5000 mg/body weight kg/day, 30 to 5000 mg/body weight kg/day or 80 to 4000 mg/body weight kg/day. … The effective amount is usually expressed as an amount in a dry-weight basis.” [0077] Second, “[4] The composition according to any of [1] to [3], wherein the content of the bacterium of the genus Acidipropionibacterium or a processed product thereof is 0.01 mass % or more on a dry-weight basis.” [0103]. The specification discusses compositions comprising 10 to 40 mass% separately: “Accordingly, the content of a bacterium of the genus Acidipropionibacterium or a processed product thereof in a composition of the present invention may fall within the range of, for example, … 10 to 40 mass %.” [0044].
The specification does not disclose any specific formulations that have A. acidipropionici or processed products thereof in the range of 10 to 40 mass%, either in the working examples or in other parts of the specification.
The specification describes three media compositions in Tables 1-3, and teaches that A. acidipropionici is grown in medium 3 [0132]. The specification’s working examples show that A. acidipropionici promotes the growth of Faecalibacterium prausnitzii on an agar plate [Example 1, Table 4] and in liquid medium [Example 2, Figure 3, 0142]. In both examples, the bacteria are diluted; in Example 1 the bacteria are diluted in Medium 3 to a final concentration of 1% [0132] and in Example 2 the bacterial cell pellet is suspended in saline to obtain OD600 = 1.0 [0138]. The saline and bacteria composition of Example 2 is not a currently claimed composition it does not comprise a total content of a saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium in the composition is 0.1 to 5 mass%, and does not further comprise at least one additive selected from the group consisting of a protein hydrolysate, a yeast extract, a meat extract and glucose. The specification’s working examples also show that A. acidipropionici supernatant promotes the growth of F. prausnitzii in liquid medium [Example 3, 0150, Figure 4], but the supernatant is not a currently claimed composition because it has ingredients at 100 mass% on a dry weight basis (the mass of the non-water components is the only mass present). Therefore, the specification teaches that the supernatant of medium 3 cannot be used as a claimed composition, and neither can other processed forms of supernatant.
The specification does not identify what the active agent is within the supernatant, and does not test different concentrations of supernatant to determine which dosage(s) of the unknown active agent are effective.
The state of the prior art and the level of predictability in the art: Coral (2008; PTO-892) teaches culturing A. acidipropionici (DSM 4900 = ATCC 25562) (pg. 10 section 4.1) in different fermentation conditions. The dry biomass production for this strain is less than 2.0 g/L (less than 0.2 mass%, assuming media has a density of approximately water’s 1 g/L) in multiple different growth conditions (Figure 10C-D on pg. 20, Figure 11C-D on pg. 21). Duarte et al. (2015; PTO-892) teaches an even lower dry biomass concentration of “One unit of OD600 was equivalent to 0.431 g L−1 [dry cell weight (DCW)]” (pg. 2 col. 2 par. 2). These references teaches that A. acidipropionici bacterial culture produces a mass% on a dry-weight basis that is well below the claimed range. Instead, in order to achieve the claimed mass% range, the composition must consist essentially of bacteria alone. Bakken and Olsen (1983; PTO-892) teach the dry weights of isolated bacteria cell pellets from three different bacterial species in the absence of other components, and found that “their dry-matter content ranged from 12 to 33% (wt/wt)” (Abstract, Table 2, Figure 1A). Therefore, the art teaches that the composition must be a highly pure bacterial pellet in order to meet the claimed mass%. A bacterial pellet cannot be considered “an oral composition” as in claim 24, or a food composition or diet as in claims 25, 27, and 38.
The quantity of experimentation needed to make or use the invention: There is no amount of experimentation that will change the dry weight content of bacteria, supernatant, or other processed products, or that will change the dry weight mass% calculation for a composition.
The specification teaches three examples, but none of them use compositions according to the claim. All three Example compositions comprise bacteria or processed products thereof at concentrations outside of the range of 10-40 mass%. For Example 1, Coral, Duarte, and Bakken each teach that bacterial culture, like the composition of Example 1, is below the required mass%. For Example 2, Bakken teaches that almost no dry mass can be added to the composition without reducing the composition below the claimed range, but the bacteria was diluted in saline which reduces the dry mass% of bacteria. For Example 3, the supernatant is 100% of the dry mass present in the supernatant composition. Also, the compositions of Examples 2-3 do not comprise the other required ingredients. Neither the specification nor the art identify what is the active ingredient in the Example 3 supernatant. So, in order to use the invention with a reasonable expectation of success, one of ordinary skill in the art would have to perform additional experimentation, with no guidance from the specification, in order to determine whether the claimed compositions are useful to promote the growth of F. prausnitzii or any other use.
The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully producing compositions with bacteria or processed products thereof with those ingredients at 10-40 mass% on a dry weight basis that are useful. Therefore, claims 16, 18, 20-21, 23-27, and 36-37 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, for failing to meet the enablement requirement.
Claims 36-38 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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.
It is apparent that the A. acidipropionici P2002701 strain, P2002702 strain, and P2002703 strain in claim 36 are required to practice the full scope of 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 the strains. The specification does not disclose the process by which these strains were isolated; it only states that “Acidipropionibacterium acidipropionici P2002701 strain, P2002702 strain or P2002703 strain is stored by Meiji Co., Ltd. (Meiji Innovation Center, 1-29-1 Nanakuni, Hachioji City, Tokyo, postal code: 192-0919, Japan).” [0033]. As the claim requires the use of the specific stored strain, the process disclosed in the specification does not appear to be repeatable. 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.
The strain “FO12425” from claims 36-37 also needs to be deposited as it is not well known and readily available, but the strain “IFO12425” from the specification is widely used in the art at the time of filing.
Claim 38 is also rejected as it depends from claim 36 and does not obviate this rejection.
It is noted that Applicants have stored the biological material but there is no indication in the specification as to whether/where it has been deposited and its public availability. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
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).
Claims 16, 18, 20-21, 23-27, and 36-38 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.
Claim 16 has been amended to recite “A composition comprising a bacterium of the genus Acidipropionibacterium acidipropionici or a processed product thereof, wherein the content of the bacterium of the genus Acidipropionibacterium acidipropionici or the processed product thereof in the composition is 10 to 40 mass% on a dry-weight basis, wherein the processed product is culture supernatant or a heat-processed product, a concentrate, a sterilized product, a liquefied product, a paste, a dried product or a diluted product thereof, wherein a total content of a saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium in the composition is 0.1 to 5 mass% or less, or the composition further comprising at least one additive selected from the group consisting of a protein hydrolysate, a yeast extract, a meat extract and glucose.”
Applicant’s arguments (pg. 8) argue that the mass% of the bacterium being 10 to 40% is supported by [0027] of the specification, which corresponds to [0044] of the Pre-Grant Publication. “Accordingly, the content of a bacterium of the genus Acidipropionibacterium or a processed product thereof in a composition of the present invention may fall within the range of, for example, … 10 to 40 mass %.” [0044]. The section pointed to does not address dry-weight; in fact, the arguments do not point out support for dry-weight.
A review of the specification identifies two different locations where dry weight is discussed. First, “according to a preferable embodiment of the present invention, the effective amount of a bacterium of the genus Acidipropionibacterium or a processed product thereof is preferably 0.01 to 10000 mg/body weight kg/day, more preferably 0.1 to 9000 mg/body weight kg/day, further preferably 1 to 6000 mg/body weight kg/day, and still further preferably 5 to 6000 mg/body weight kg/day, 10 to 5000 mg/body weight kg/day, 30 to 5000 mg/body weight kg/day or 80 to 4000 mg/body weight kg/day. … The effective amount is usually expressed as an amount in a dry-weight basis.” [0077] Second, “[4] The composition according to any of [1] to [3], wherein the content of the bacterium of the genus Acidipropionibacterium or a processed product thereof is 0.01 mass % or more on a dry-weight basis.” [0103]. These ranges do not correspond to the 10 to 40 mass% that is currently claimed, and there is no indication in the specification that the range disclosed at [0044] (10-40 mass%) is related to the ranges disclosed in [0077], which uses different units and discusses effective doses rather than composition formulation, and in [0103], which is much broader than the currently claimed range.
Also, it is noted that the specification does not provide any examples of compositions with the claimed mass% range on a dry-weight basis as discussed above in the enablement rejection, and dependent claims related to oral and food administration are inconsistent with a composition where almost all of the non-water mass is from bacterial cells or where 10-40% of the non-water mass is salts and other ingredients from the supernatant.
Therefore, the examiner cannot find support for the newly added limitation in the specification, and the limitation constitutes new matter. Claims depending from claim 16 are also rejected because they do not obviate this rejection.
Conclusion
No claims are allowed.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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