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 without traverse of Group 1 (claims 16-27, a composition comprising a bacterium of the genus Acidipropionibacterium or a processed product thereof) in the reply filed on 20 Nov 2025 is acknowledged. Claims 28-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Claim Status
The amended claim set filed 15 June 2023 is acknowledged. Claims 16-35 are currently pending. Of those, claims 16-35 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 Claims 28-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 are cancelled. Claims 16-27 will be examined on the merits herein.
References to paragraph numbers herein use the paragraph numbers from the pre-grant publication US20240041949A1.
Priority
The instant application claims priority to the foreign priority document JP2020-204427 (filed 9 Dec 2020) and is a 371 of PCT/JP2021/045043 (filed 8 Dec 2021). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, support for the claimed subject matter in the foreign priority document cannot be assessed because an English translation has not been filed. So for the sake of searching the art, the effective filing date used is 8 Dec 2021 for all claims.
The Office is not requiring that the foreign priority document be translated, but applicant cannot rely upon the earlier date from the certified copy of the foreign priority application to overcome an art rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8 June 2023 (two IDSes), 14 Jan 2025, and 16 Oct 2025 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the experimental results as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Specifically, [0134] states “In FIG. 2 , proliferation of F. prausnitzii was observed around the black dot. The area in which F. prausnitzii proliferated is twice as large as that of the dot.” However, the image of Figure 2 only shows a black dot, there is no visible region of proliferation that is darker than the rest of the plate as shown in Figure 1.
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Examiner’s view of partial Figure 1 and Figure 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: [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.
Claim Interpretation
Regarding the species “Acidipropionibacterium acidipropionici”, the species has been renamed and was previously referred to in the art as “Propionibacterium acidipropionici”, as evidenced by Turgay et al. (2008; made of record in IDS filed 8 June 2023; Table 1 on pg. 2). In the interest of clarity, in this action the bacteria will only be referred to as A. acidipropionici to correspond with the claim language and the nomenclature at the time of filing.
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 20-22 and 27 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.
Claims 20-22 each recite the limitation "the saccharide". There is insufficient antecedent basis for this limitation in the claim because parent claim 16 recites both “a saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium” and the saccharide “glucose”. In the interest of compact prosecution, “the saccharide” is interpreted as referring to “a saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium” in view of the examples of the specification.
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.
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 16-27 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.
MPEP 2163 states:
An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
The claims recite the term “a processed product thereof”, either directly or by depending from claim 16. One of ordinary skill in the art would be aware that standard “processing” processes could result in a broad range of products that have no relationship to the original bacteria (for example, processing to purify a specific chemical product present in the bacteria). For example, Kouya et al. (2007; made of record in IDS filed 8 June 2023) teaches processing A. acidipropionici “for [bifidogenic growth stimulator (BGS)], [1,4-dihydroxy-2-naphthoic acid (DHNA)], [2-amino-3-carboxy-1,4-naphthoquinone (ACNQ)], glucose, lactic acid, acetic acid, and propionic acid concentrations” (par. bridging pg. 465-466).
However, the instant specification does not discuss compositions comprising these chemical “processed products”. The examples of the specification only test the effect of whole A. acidipropionici in culture (Examples 1-2) and culture supernatant after A. acidipropionici growth (Example 3). The examples do not process the culture further to purify any specific components. Beyond the examples, the specification’s discussion of purified products is at a high level of generality. The specification teaches a variety of possible processing methods: “Such a processed product of the isolated bacterial cells, that is, a concentrated product, a ground product, a past-like product, a sterilized product, a diluted product or a dried product, can be also used.” [0041] “A culture solution can be directly used as a processed product of a bacterium of the genus Acidipropionibacterium without being subjected to an isolation process.” [0042] “A method for preparing culture supernatant is not particularly limited. The culture supernatant is prepared, for example, by centrifuging a culture solution, collecting the supernatant and filtering it to remove bacterial cells. The culture supernatant may be subjected to a process such as a concentration process, a pasting-formation process, a sterilization process, a heating process (e.g., dissolution treatment), a dilution process or a drying process. A processed product of a culture supernatant such as a concentrated product, a paste-like product, a sterilized product, a diluted product or a dried product can be used.” [0043]. However, the specification does not contemplate the product(s) that might result from the process and does not contemplate how the resulting product(s) should be used. For example, the saline control used in Examples 2-3 contains water, which is a sterilized product that can be isolated from water-containing bacterial cells or culture using a heating process of distillation; but the specification describes this sample as a “control” rather than a second inventive composition.
When viewing the specification in view of the art at the time of filing, one of ordinary skill in the art would believe that the specification has demonstrated possession of inventions that comprise whole Acidipropionibacterium bacteria, lysed or killed Acidipropionibacterium bacteria preparations, and whole supernatants, which may each be treated in a variety of ways as described in the specification such as mixing into a suspension with other ingredients, heating, grinding, concentrating, drying, etc. However, one of ordinary skill in the art would not consider these species to be representative of all possible compositions comprising isolated components from Acidipropionibacterium bacteria, such as water, 1,4-dihydroxy-2-naphthoic acid (DHNA), 2-amino-3-carboxy-1,4-naphthoquinone (ACNQ), glucose, lactic acid, acetic acid, and propionic acid. The properties of the complex cell and supernatant compositions are not representative of the simpler compositions comprising purified chemicals, particularly because processing to produce the simpler chemical compositions could completely remove all traces of their origin from Acidipropionibacterium bacteria or Acidipropionibacterium bacterial culture. Also, the specification does not provide any indication that one should consider highly processed chemical compositions like water to have representative properties that could be used in place of bacteria or supernatant. Therefore, one of ordinary skill in the art would not believe that the specification has demonstrated possession of the full breadth of “processed products”. Claims 16-27 are rejected as lacking written description for reciting the phrase either directly or by depending from claim 16.
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 16-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kouya et al. (2007; hereafter Kouya; made of record in IDS filed 8 June 2023).
Regarding claims 16-17, 21-23, Kouya teaches a composition teaches “Propionibacterial strains were cultivated in TPY medium containing 30 g of glucose, 8 g of trypticase peptone (Becton Dickinson, Franklin Lakes, NJ, USA), 3 g of phytone peptone (Becton Dickinson), 5 g of yeast extract (Becton Dickinson), 2 g of K2HPO4, 3 g of KH2PO4, 0.5 g of MgCl2 ⋅ 6H2O, 0.5 g of L-cysteine, and 0.01 g of FeSO4⋅7H2O per liter (pH 6.5)” (pg. 465 col. 2 par. 3), and that the propionibacterial strains included A. acidipropionici JCM 6427 and A. acidipropionici JCM 6432 (pg. 465 col. 2 par. 2, see claim 18). So, the media composition comprises a bacterium of the genus Acidipropionibacterium, and the processed product water, which is a chemical found in the bacterial cells that could be isolated by processing. The media comprises 30 g/L of glucose (approximately 3% by mass, approximation based on media having a density of 1g/L, see claim 22), which is a saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium as evidenced by the instant specification growing F. prausnitzii in media 2 using glucose [instant specification Table 2, 0126, 0128] (see claim 23), and 0g/L of inulin and 1-kestose (0% by mass, see claim 21), which is a saccharide that promotes proliferation of a bacterium of the genus Faecalibacterium as evidenced by the instant specification [instant specification 0005]. The media composition comprises peptone (a protein hydrolysate) and yeast extract.
Regarding claim 18, the processed product water is a sterile product because it does not have live bacteria in it. Also, Kouya teaches “The microorganisms were precultured statically in test tubes containing TPY medium for 36–48 h. The precultured cells were inoculated into TPY medium at an initial turbidity of about 0.1 at 660 nm” (pg. 465 col. 2 par. 3) and “The culture broth was diluted 100 times and then 0.1 ml of the diluted culture broth was inoculated into 10 ml of melted TPY agar medium” (pg. 465 col. 2 par. 4). So the bacteria were added in the form of a processed product that is a culture and a suspension, and is sometimes added as a diluted product.
Regarding claim 19, 0.1 mL of the diluted culture broth (processed product thereof) is added into 10mL of culture, which is approximately 1% by mass (approximation based on both media having the same density).
Regarding claim 20, glucose is a monosaccharide. Inulin and 1-kestose are Fermentable Oligosaccharides, Disaccharides, Monosaccharides or Polyols, as evidenced by instant specification [0006].
Regarding claim 24-25, the Kouya media is capable of use as an oral/food composition because the ingredients can be consumed orally and the composition contains nutrients such as glucose for the organism consuming it.
Regarding claim 26, the Kouya media is a probiotic because it comprises live microorganisms [see definition of the term “probiotic” in instant 0069].
Regarding claim 27, the Kouya media is a low-FODMAP composition because it does not comprise any fructose or fructans (see par. 17 above for the definition of low-FODMAP that is used in this action).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lorenzo-Pisarello et al. (2010; PTO-892) teaches “The presence of [A. acidipropionici] limited the growth of Bacteroides fragilis and Clostridium hystoliticum groups in slurries with and without inulin. The growth of Bifidobacterium was not modified…” (Abstract). The art teaches that Bifidobacterium was known to the art to not have modified growth when co-cultured with A. acidipropionici (as also shown in instant Example 1).
Babot et al. (2018; PTO-892) teaches “Regarding joint growth of LAB and [A]. acidipropionici LET103 or [Bifidobacterium] infantis CRL1395, inhibition of the latter was observed in MRS solid medium. In contrast, no inhibition of these strains by LAB was evidenced in LAPTg ([A]. acidipropionici LET103) or LAPTg supplemented with 10 g/l lactose (B. infantis CRL1395) solid media. Moreover, joint growth of [A]. acidipropionici LET103 and B. infantis CRL1395 had no effect on their growth in either solid media.” (pg. 4 col. 2 par. 3). The art teaches that Bifidobacterium was known to the art to not have modified growth when co-cultured with A. acidipropionici on solid media (as also shown in instant Example 1).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645