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 .
DETAILED ACTION
Claims 1-5, 8-13, 16-17 and 19-23 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/12/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/02/2025 is acknowledged and has been considered.
Claim Objections
Claims 5 and 8 are objected to because the phrase “at least one of good bacteria” is ungrammatical. Applicant may consider amending the claims to:
Claims 5. A method for increasing Ruminococcaceae and/or Akkermansia in a subject in need of alleviating constipation, comprising administering to the subject 100 mg/day of a composition consisting of 3 x 109 CFU of Limosilactobacillus fermentum TCI275 with an accession number of DSM 33289, 3x108 CFU of Bifidobacterium animalis subsp. lactis TCI604 with an accession number of DSM 33303, and 9x108 CFU of Weizmannia coagulans TCI803 with an accession number of DSM 33486.
Claim 8. The method according to claim 5, wherein the abundance of the at least one bacterium is improved by increasing a content of short-chain fatty acids (SCFAs) in the subject.
Claim 13 is objected to because the phrase “at least one of pathogenic bacteria” is ungrammatical. Applicant may consider amending the claim to:
Claim 13. A method for alleviating abdominal bloating in a subject in need thereof, comprising administering to the subject 100 mg/day of a composition consisting of 3x 109 CFU of Limosilactobacillus fermentum TCI275 with an accession number of DSM 33289, 3x108 CFU of Bifidobacterium animalis subsp. lactis TCI604 with an accession number of DSM 33303, and 9x108 CFU of Weizmannia coagulans TCI803 with an accession number of DSM 33486, wherein the alleviation of abdominal bloating is achieved by reducing the abundance of Bilophila and/or Veillonella.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 5, 8-13, 16 and 19 -23 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 5, 13 and 19 recite 100 mg/day of a composition consisting of 3x109 CFU of Limosilactobacillus fermentum TCI275, 3x108 CFU of Bifidobacterium animalis subsp. lactis TCI604, and 9x108 CFU of Weizmannia coagulans TCI803. In the art, the mass of a typical bacterium is estimated as 1pg (i.e., 10-9 mg) as reported by Physics Factbook (The Physics Factbook, Mass of a bacterium, 2003). Thus, a composition consisting of 4.2x109 CFU of bacteria is estimated to have a mass of 4.2 mg. The claim is indefinite because it is not clear if the recited 100mg/day dose is achieved by administering the 4.2 mg of bacteria multiple times a day or if the composition has other components such as additives and excipients to bringing its weight to 100mg.
Claims 8-12, 16 and 20-23, which depend from claims 5, 13 and 19 respectively, do not cure the indefiniteness and are also rejected.
Claim Rejections - 35 USC § 103
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.
Claims 5, 8-13, 16-17 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (TW2021115244 published 04/16/2021, of record in IDS filed on 11/30/2023) in view of Huang (TW202108759, published 03/01/2021, of record in IDS filed on 11/30/2023) and Yung (TW202100174, published 01/01/2021, of record in IDS filed on 11/30/2023).
Regarding claim 5, Lin teaches Lactobacillus fermentum TCI275 with accession number BCRC 910940/DSM 33289, used as food compositions or pharmaceutical compositions (Abstract). Lin teaches 50mg of TCI275 bacterial powder containing 5x109 bacterial counts of Lactobacillus fermentum TCI275 taken every day (claim 8, Example 4). Lin teaches the bacterium is beneficial for the guts (improving lactose intolerance, improving loose stools, reducing the frequency of flatulence, reducing flatulence, reducing abdominal pain, reducing constipation, increasing the proportion of Prevotella species and Faecalibacterium strains in the stomach of an individual which produce short-chain fatty acids) (claims 10, 13, 15, example 5).
Lin does not teach Weizmannia (Bacillus) coagulans TCI803 with accession number BCRC 910946/DSM 33289 and Bifidobacterium lactis TCI604 with accession number BCRC 910887/DSM 33303 in the composition.
However, Huang teaches Bacillus coagulans TCI803 with accession number BCRC 910946/DSM 33289 and the use of this strain in compositions for stomach health such as increasing gastric mucin production, reducing inflammation of the stomach, improving defecation (Abstract, claim 6, example 5, Table 7). Huang teaches Bacillus coagulans TCI803 improves flatulence (Table 5). Huang teaches the effective dose of Bacillus coagulans TCI803 is 5×109 CFU/day (claim 10) and teaches administering 50 mg/day containing 5x109 Bacillus coagulans TCI803 (Example 6). Applicant discloses Weizmannia coagulans TCl803 has an accession number of BCRC 910946 ([0009]). Thus, Bacillus coagulans TCI803 taught by Huang and instant strain Weizmannia coagulans TCl803 are the same strain.
Yung teaches Bifidobacterium lactis TCI604 with accession number BCRC 910887/DSM 33303, used in compositions and teaches the strain improves gastrointestinal function and helps digestion (Abstract). Yung teaches Bifidobacterium lactis TCI604 improves flatulence (Figure 5). Yung teaches a daily dose of 5x108 to 5x1010 CFU of Bifidobacterium lactis TCI604 (Example 5, page 4 para 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Lin by combining the three strains in a composition, to optimize the dosage of bacteria and amount of daily dose, and to use the composition to improve gut microbiota of a subject as suggested by Huang and Yung, with a reasonable expectation of success. One of ordinary skill in the art would be motivated to do so in order to form a composition beneficial for the gut and to increase the proportion of beneficial bacteria in the gut. Since Lin, Huang, and Yung teach the same population (i.e., human subject in need of improving gastrointestinal function) and same active step (i.e., administering an effective dose of the strains) as the instant claims, the limitation of increasing an abundance of at least one of good bacteria for alleviating constipation wherein the at least one of good bacteria is Ruminococcaceae, Akkermansia, or a combination thereof will be met when the teachings of Lin, Huang, and Yung are practiced.
Since Lin, Huang, and Yung teach a desire to form a composition for intestinal health and since Yung teaches the dosage of bacteria can be optimized, there is a motivation for optimizing the dose and a reasonable expectation of success.
Regarding claims 8-11, the recited clauses do not further limit the active method step already recited in claim 5 of administering the composition and are merely stating the result that happens when the composition is administered. They do not require additional steps to be performed. MPEP 2111.04 provides a discussion of wherein and contingent clauses in general and states that claim scope is not limited by claim language that suggest or makes optional but does not require steps to be performed.
Regarding claim 12, Lin, Huang, and Yung teach the claimed strains with the same accession numbers. Thus, the origin of the isolation of the strains is not limiting since the strains taught in the prior art are the same as the claimed strains.
Regarding claim 13, Lin teaches Lactobacillus fermentum TCI275 with accession number BCRC 910940/DSM 33289, used as food compositions or pharmaceutical compositions (Abstract). Lin teaches that the composition comprises 5x109 bacterial counts of Lactobacillus fermentum TCI275 (claim 8). Lin teaches the bacterium is beneficial for the guts (improving lactose intolerance, improving loose stools, reducing the frequency of flatulence, reducing flatulence, reducing abdominal pain, reducing constipation, increasing the proportion of Prevotella species and Faecalibacterium strains in the stomach of an individual) (claims 10, 13, 15, example 5).
Lin does not teach the Weizmannia (Bacillu)s coagulans TCI803 with accession number BCRC 910946/DSM 33486 and Bifidobacterium lactis TCI604 with accession number BCRC910887/DSM 33303 in the composition.
However, Huang teaches Bacillus coagulans TCI803 with accession number BCRC 910946/DSM 33486 and teaches the use of this strain in compositions for stomach health such as increasing gastric mucin production, reducing inflammation of the stomach, improving defecation (Abstract, claim 6, example 5, Table 7). Huang teaches Bacillus coagulans TCI803 improves flatulence (Table 5). Huang teaches the effective dose of Bacillus coagulans TCI803 is 5×109 CFU/day (claim 10). Applicant discloses Weizmannia coagulans TCl803 has an accession number of BCRC 910946 ([0009]). Thus, Bacillus coagulans TCI803 taught by Huang and instant strain Weizmannia coagulans TCl803 are understood to be the same.
Yung teaches Bifidobacterium lactis TCI604 with accession number BCRC910887/DSM 33303 in compositions and that the strain improves gastrointestinal function and helps digestion (Abstract). Yung teaches Bifidobacterium lactis TCI604 improves flatulence (Figure 5). Yung teaches a dose of 5x109 CFU of Bifidobacterium lactis TCI604 (Example 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Lin by combining the three strains in a composition, with a reasonable expectation of success. One of ordinary skill in the art would be motivated to do so in order improve gastrointestinal function. Since Lin, Huang, and Yung teach the same population (i.e., human subject in need of improving gastrointestinal function) and same active step (i.e., administering an effective dose of the strains) as the instant claims, the limitation of alleviating abdominal bloating in a subject in need thereof will be met when the teachings of Lin, Huang, and Yung are practiced.
The limitation of “wherein the alleviation of abdominal bloating is achieved by reducing an abundance of at least one of pathogenic bacteria, and the at least one of pathogenic bacteria is Bilophila bacteria, Veillonella bacteria, or a combination thereof” is the result of the active method step and does not require additional steps. Wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding claim 16, the recited clause does not further limit the active method step already recited in claim 13 (administration of the composition) and is merely stating the result that happens when the composition is administered. The claim scope is not limited by claim language that suggest or makes optional but does not require steps to be performed.
Regarding claim 17, Lin teaches Lactobacillus fermentum TCI275 with accession number BCRC 910940/DSM 33289 used as food compositions or pharmaceutical compositions (Abstract). Lin teaches the composition comprises 5x109 bacterial counts of Lactobacillus fermentum TCI275 (claim 8). Lin teaches the bacterium is beneficial for the guts (improving lactose intolerance, improving loose stools, reducing the frequency of flatulence, reducing flatulence, reducing abdominal pain, reducing constipation, increasing the proportion of Prevotella species and Faecalibacterium strains in the stomach of an individual) (claims 10, 13, 15, example 5).
Lin does not teach the composition includes Bacillus coagulans TCI803 with accession number BCRC 910946/DSM 33486 and Bifidobacterium lactis TCI604 with accession number BCRC910887/DSM 33303.
However, Huang teaches Bacillus coagulans TCI803 with accession number BCRC 910946/DSM 33486 and teaches the use of this strain in compositions for stomach health such as increasing gastric mucin production, reducing inflammation of the stomach, improving defecation (Abstract, claim 6, example 5, Table 7). Huang teaches Bacillus coagulans TCI803 improves flatulence (Table 5). Huang teaches the effective dose of Bacillus coagulans TCI803 is 5×109 CFU/day (claim 10). Applicant discloses that Weizmannia coagulans TCl803 has an accession number of BCRC 910946 ([0009]). Thus, Bacillus coagulans TCI803 taught by Huang and instant strain Weizmannia coagulans TCl803 are understood to be the same.
Yung teaches Bifidobacterium lactis TCI604 with accession number BCRC 910887/DSM 33303 in compositions and that the strain improves gastrointestinal function and helps digestion (Abstract). Yung teaches Bifidobacterium lactis TCI604 improves flatulence (gas sensation) (Figure 5). Yung teaches a dose of 5x109 CFU of Bifidobacterium lactis TCI604 (Example 5).
Lin, Huang, and Yung do not teach an inoculum size ratio of Limosilactobacillus fermentum TCI275, Bifidobacterium animalis subsp. lactis TCI604, and Weizmannia coagulans TCI803 is 1:1:1. However, Lin, Huang, and Yung teach each of these strains is beneficial for gut health, and teach the same effective dose of the strains (5x109 bacterial counts of Lactobacillus fermentum TCI275, 5×109 CFU/day of Bacillus coagulans TCI803, and of 5x109 CFU of Bifidobacterium lactis TCI604).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Lin by combining the three strains in a composition using equal amount of the strains and to use the composition to improve gut microbiota of a subject as suggested by Huang and Yung, with a reasonable expectation of success. One of ordinary skill in the art would be motivated to do so in order to improve gastrointestinal function. Since Lin, Huang, and Yung teach the same population (i.e., human subject in need of improving gastrointestinal function) and same active step (i.e., administering an effective dose of the strains) as the instant claims, the limitation of inhibiting growth of gas producing microbiota in a subject in need thereof wherein the gas producing microbiota is E. coli. will be met when the teachings of Lin, Huang, and Yung are practiced.
Regarding claim 19, Lin teaches the Lactobacillus fermentum TCI275 that has two accession numbers, BCRC 910940 and DSM33289, used as food compositions or pharmaceutical compositions (Abstract). Lin teaches the composition comprises 5x109 bacterial counts of Lactobacillus fermentum TCI275 (claim 8). Lin teaches the bacterium is beneficial for the guts (improving lactose intolerance, improving loose stools, reducing the frequency of flatulence, reducing flatulence, reducing abdominal pain, reducing constipation, increasing the proportion of Prevotella species and Faecalibacterium strains in the stomach of an individual) (claims 10, 13, 15, example 5).
Lin does not teach the Weizmannia (Bacillus) coagulans TCI803 with accession number DSM 33486 and Bifidobacterium lactis TCI604 with accession number DSM 33289 in the composition.
However, Huang teaches the Weizmannia (Bacillus) coagulans TCI803 that has two accession numbers, BCRC 910946 and DSM 33486, and the use of this strain in compositions for stomach health such as increasing gastric mucin production, reducing inflammation of the stomach, improving defecation (Abstract, claim 6, example 5, Table 7). Huang teaches the effective dose of Bacillus coagulans TCI803 is 5×109 CFU/day (claim 10). Applicant discloses Weizmannia coagulans TCl803 has an accession number of BCRC 910946 ([0009]). Thus, Bacillus coagulans TCI803 taught by Huang and instant strain Weizmannia coagulans TCl803 are understood to be the same.
Yung teaches the Bifidobacterium lactis TCI604 that has two accession numbers, BCRC910887 and DSM 33303, used in compositions and teaches the strain improves gastrointestinal function and helps digestion (Abstract). Yung teaches a dose of 5x109 CFU of Bifidobacterium lactis TCI604 (Example 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Lin by combining the three strains in a composition, optimizing the dosage, and using the composition to improve gut microbiota of a subject as suggested by Huang and Yung, with a reasonable expectation of success. One of ordinary skill in the art would be motivated to do so since Lin, Huang, and Yung teach administering these strains is beneficial for the gut and Lin teaches the strain increases the proportion of beneficial bacteria. Since Lin, Huang, and Yung teach the same population (i.e., human subject) and same active step (i.e., administering an effective dose of the strains) as the instant claims, the limitation of increasing content of short-chain fatty acids in a subject in need thereof, will be met when the teachings of Lin, Huang, and Yung are practiced.
Regarding claims 20-22, the limitations “wherein the composition has an effect of overcoming difficulty in burping”, “wherein the composition has an effect of alleviating abdominal bloating”, and “wherein the composition has an effect of relieving a feeling of abdomen tied in knots” are the result of the recited method step and do not require additional steps to be performed, thus do not limited the claim scope.
Regarding claim 23, Lin, Huang, and Yung teach the claimed strains with the same accession numbers. Thus, the origin of the isolation of the strains is not limiting since the strains taught in the prior art are the same as the claimed strains.
Response to Arguments
Applicant's arguments filed 08/12/2025 have been fully considered but they are not persuasive.
Applicant argues: none of the cited references discloses or teaches a combination of 3x109 CFU of Limosilactobacillus fermentum TCI275, 3x 108 CFU of Bifidobacterium animalis subsp lactis TCI604, and 9x 108 CFU of Weizmannia coagulans TCI803 in 100 mg of the composition of the claimed invention; and Example 1 of this application is evident that not all combinations of three bacterial strains beneficial for the intestinal flora would exhibit the same inhibitory effect against gas production.
While the exact dosage of 3x109 CFU of Limosilactobacillus fermentum TCI275, 3x108 CFU of Bifidobacterium animalis subsp. lactis TCI604, and 9x108 CFU of Weizmannia coagulans TCI803 are not taught by the prior art, one of ordinary skill in the art would be motivated to optimize the dosage to produce an effective composition for improving intestinal health.
Lin teaches Lactobacillus fermentum TCI275 with accession number BCRC 910940 has an effect on constipation, flatulence and abdominal pain (Examples 4 and 5), and teaches the strains increases the proportion of Prevotella species and Faecalibacterium strains. Lin teaches these two strains promote production of short-chain fatty acids and regulate constipation. Yung teaches Bifidobacterium lactis TCI604 improves flatulence (Figure 5). Huang teaches Bacillus coagulansTCI803 improves flatulence (Table 5). The effect of reducing the gas production is not unexpected in view of the teachings of Lin, Huang, and Yung. The prior art teaches composition consisting of the recited strains have a beneficial effect on the gastrointestinal health and flatulence. Thus, one of ordinary skill in the art would be motivated to combine them since they are used for the same purpose. MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”
The prior art teaches the effect of each single strain, and teaches each strain by itself has an effect an effect on intestinal gas as discussed above. Thus, the result or reduction in gas production is not unexpected. None of the instant claims require any particular amount of gas production rate and thus any rate would fall within the scope claimed. Every single experimental group in FIG. 1 and Table 3 reduces the gas production rate compared to control.
Applicant argues none of cited references discloses or teaches the function of increasing an abundance of at least one of good bacteria (i.e., Ruminococcaceae, Akkermansia, or a combination thereof) for alleviating constipation, reducing an abundance of at least one of pathogenic bacteria (i.e., Bilophila bacteria and/or Veillonella) to alleviate abdominal bloating in a subject, inhibiting growth of gas producing microbiota (i.e., E. coli), and increasing content of short-chain fatty acids as recited in the claimed invention. Applicant argues the supplementary experimental data shown on page 11 of the Remarks shows that the composition of the claimed invention had no positive effect on increasing the abundance of Faecalibacterium in the human body, and had a negative effect on the abundance of Prevotella.
In response to the argument, the prior art teaches the same patient population (i.e., human subject in need of improving gastrointestinal function), same bacterial strains, and same active method step of administering the strains. Lin teaches the composition increases the frequency of defecation and improves constipation (Table 8) and teaches the increase in abundance of Faecalibacterium and Prevotella which are SCFA producers. The prior art teaches each strain has an effect on flatulence. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The prior art teaches the claimed bacteria and teaches their beneficial effect on the intestinal health of a subject. Thus, there is a motivation to combine these strains in a composition to improve the intestinal health of a subject. The prior art also teaches the strains affected the relative abundance of bacteria in the subject’s gut.
Lin teaches taking the live bacteria capsule of Lactobacillus fermentum TCI275 for 2 weeks can increase the proportion (relative abundance) of Prevotella and Faecalibacterium strains (Figures 2-3) which promote the production of short-chain fatty acids. Lin does not teach the abundance of the strains after 4 weeks as presented in the supplementary experimental data presented by Applicant (Remarks page 11). The increase in production of short-chain fatty acids as well as the alteration of bacteria in the subject’s gut are not unexpected in view of the teachings of Lin, Huang, and Yung.
Applicant argues none of the cited references teach the inoculum size of these three strains being 1:1:1 of the claimed invention.
In response to the argument, Lin, Huang, and Yung teach each of these strains is beneficial for gut health, and teach the same effective dose of the strains (5x109 bacterial counts of Lactobacillus fermentum TCI275, 5×109 CFU/day of Bacillus coagulans TCI803, and of 5x109 CFU of Bifidobacterium lactis TCI604). One of ordinary skill in the art would be motivated to combine equal amount of the strains into a composition and to use the composition to improve gut microbiota of a subject as suggested by Lin, Huang and Yung, with a reasonable expectation of success.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/MARY A CRUM/Examiner, Art Unit 1657