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
This application is a US national phase of PCT/EP2022/054979, filed February 28, 2022, with foreign application EP21159973.3, filed March 1, 2021.
A preliminary amendment was filed on August 30, 2023. Claims 1-17 are canceled. Claims 18-37 are newly added and pending.
Election/Restrictions
Applicant’s species election of Lactobacillus plantarum subsp. argentoratensis and SEQ ID NO: 24, without traverse, in the reply filed on December 3, 2025 is acknowledged. Claims 26-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 18-25 and 32-37 are under examination.
Specification
The abstract of the disclosure is objected to because it is too brief and does not adequately describe the invention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to because the drawings are labeled “Figure” instead of “FIG.”. See MPEP 608.02 V. DRAWING STANDARDS (u):
(u) Numbering of views.
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.
(2) Numbers and letters identifying the views must be simple and clear and must not be used in association with brackets, circles, or inverted commas. The view numbers must be larger than the numbers used for reference characters.
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.
Claim Objections
Claims 23 and 24 are objected to because of the following informalities: missing a comma after ‘methyl acrylate’ for proper grammar. 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 18-25 and 32-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites “A preparation comprising: - at least one probiotic strain belonging to the genus Lactobacillus paracasei (Lacticaseibacillus paracasei);…Lactobacillus reuteri (Limosilactobacillus reuteri); or Lactobacillus hilgardii (Lentilactobacillus hilgardii); and – L-tryptophan or a dipeptide containing L-tryptophan; or – a foodstuff, fruit or plant or meat extract containing L-tryptophan.”. First, the open list of species are not a ‘genus’, and it is unclear if the composition requires at least one strain from each listed species, or at least one species from the group. The proper language for a Markush grouping is “at least one probiotic strain selected from the group consisting of: Lactobacillus paracasei (Lacticaseibacillus paracasei), Lactobacillus brevis (Levilactobacillus brevis), Lactobacillus delbruecki, Lactobacillus crispatus, Lactobacillus plantarum (Lactiplantibacillus plantarum), Lactobacillus plantarum subspecies argentoratensis, Lactobacillus reuteri (Limosilactobacillus reuteri), and Lactobacillus hilgardii (Lentilactobacillus hilgardii)”. Second, the format of the claim is ambiguous as to what is required in the composition, as there is an ‘and’ between the first and second hash marks, and an ‘or’ between the second and third hashmarks, which is unclear if the composition requires the probiotic strain and L-tryptophan, OR only ‘a foodstuff’ containing L-tryptophan. Furthermore, ‘a foodstuff, fruit or plant or meat extract containing L-tryptophan’ is unclear if the ‘fruit or plant or meat extract’ are alternative forms of the ‘foodstuff’, or if the ‘extract’ is only meat extract or extract of the ‘fruit or plant or meat’, which this phrase is also recited in claims 19-20.
Claims 19 and 20 recite “comprises the probiotic and a foodstuff,…at a concentration of at least 0.01/0.10 weight-%.”. It is unclear if the ‘a foodstuff’ is the same ‘foodstuff’ recited in independent claim 18 or another foodstuff, thus introduces ambiguity as to what is required in the composition. It is also unclear if the probiotic and foodstuff are at least 0.01/0.10 % w/w in relation to the total composition or in relation to each other, as the composition in claim 18 recites ‘comprising’ which is open-ended, and could include other unrecited elements.
Claim 21 recites “…further comprising a targeted-release formulation for delayed release or enteric or colonic release.”. It is unclear what constitutes a ‘targeted-release formulation’ as there is no definition in the specification. The specification discloses ‘targeted strategies’ include the application of prebiotics, probiotics, and synbiotics to modulate the microbiota’s composition and activity. The specification also discloses the combination of Trp and Lactobacillus strains facilitate a targeted release in the distal parts of the gastrointestinal tract, which by that definition claim 21 would be inherent to the composition in claim 18, thus not further limiting the claim. The specification generally defines the ‘targeted-release formulation’ as ensuring delivery of the component to a specific target in the body, promoting enteral or colonic delivery in the lower small intestine or large intestine, also mentioning specific coatings and enteric polymers to aid in the delivery system. Thus it is unclear the scope of ‘targeted-release formulation’ and one of ordinary skill in the art would not be apprised to the metes and bounds of the claim, therefore indefinite.
Claims 32 and 33 recite ‘…wherein the probiotic strain is Lactobacillus plantarum subspecies argentoratensis and exhibits the following characteristics: a)-f)’. It is unclear if the strain is required to exhibit all of the characteristics in a)-f) or only one, or a combination, as they could appear to be alternatives in a grouping, and there is no conjunction between e) and f), such as ‘and’, ‘or’, ‘and/or’. Furthermore, Applicant elected SEQ ID NO: 24 without traverse, and the instant specification on page 7, lines 33-34, discloses the strain exhibits at least one, preferably all of the recited characteristics. Therefore, one of ordinary skill in the art would not be certain what characteristics are required in the probiotic strain, thus is indefinite.
Claims 22-25 and 34-37 are likewise rejected as being dependent on an indefinite claim.
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 18-25 and 32-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring organism without significantly more.
The Supreme Court has required analysis based on a 3-part test for subject
matter eligibility.
- Step 1: Is the claim to a process, machine, manufacture, or composition of
matter?
- Step 2A (The Judicial Exceptions): Prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
-Step 2A (The Judicial Exceptions): Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
- Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
Claims 18-25 and 32-35 recite a preparation of at least one probiotic strain belonging to the genus Lactobacillus paracasei (Lacticaseibacillus paracasei), Lactobacillus brevis (Levilactobacillus brevis), Lactobacillus delbrueckii, Lactobacillus crispatus, Lactobacillus plantarum (Lactiplantibacillus plantarum), Lactobacillus plantarum subspecies argentoratensis, Lactobacillus reuteri (Limosilactobacillus reuteri), and Lactobacillus hilgardii (Lentilactobacillus hilgardii), and L-tryptophan or a dipeptide containing L-tryptophan, or a foodstuff, fruit or plant or meat extract containing L-tryptophan, and claims 36-37 recite a food supplement or food product comprising said preparation, which is a statutory category of invention (Step 1: Yes).
The claims are drawn to a composition comprising naturally occurring probiotic strains, and foodstuff containing L-tryptophan that can include natural foods such as eggs and tuna. It is not apparent that the probiotic or foodstuff containing L-tryptophan have any markedly different characteristics from their naturally occurring counterparts, thus is a product of nature. The combination of the naturally occurring elements of the composition also do not appear to result in altered function of the naturally occurring probiotics, nor result in an altered state that distinguishes from its’ naturally occurring counterpart, thus is a judicial exception (Step 2A, Prong 1: Yes).
Claims 21-24 recite the preparation can further comprise a targeted-release formulation for enteric or colonic release, but is generic to include naturally occurring elements such as zein, which is resistant to rapid digestion and present in corn gluten meal, as evidenced by CaringSunshine (Zein, Copyright 2025, <caringsunshine.com/ingredients/ingredient-zein/>). Claim 22 encompasses the targeted-release formulation comprises a coating of zein, which is commonly used in food and pharmaceutical applications, such as coating pills, as evidenced by CaringSunshine, thus is a generic application that does not integrate the claims into a practical application, nor amount to significantly more than the judicial exception. Claims 36-37 recite a food supplement or food product comprising the preparation with additional food ingredients or probiotics, inter alia. As evidenced by Kim (WO 2018/169297 A1, cited in IDS filed 9/21/2023), it is a common practice in the art to combine probiotic strains with L-tryptophan containing foods into compositions as food supplements or nutraceuticals, as well as include additional probiotics. Such combination does not effect a transformation of the natural products to a different state or thing. Therefore, the claims do not recite additional elements that integrate it into a practical application (Step 2A, Prong 2: No), nor do they recite additional elements that amount to significantly more than the judicial exception (Step 2B: No).
Therefore, claims 18-25 and 32-37 are not patent eligible subject matter.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 18-21, 34, and 36-37 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kim (WO 2018/169297 A1, cited in IDS filed 9/21/2023), as evidenced by Sharma et al. (Int’l Jrnl of Pharm Research and Applications, 2025, vol. 10, issue 2, pgs. 1224-1232, hereinafter “Sharma”).
Regarding claim 18, Kim teaches compositions comprising Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus delbueckii and L-tryptophan (claims 15 & 24).
Regarding claims 19-20, Kim teaches the compositions comprises the probiotic strain from 0.1 to 10% by weight of the food (claim 22), and the foodstuff can be nuts, egg, inter alia (claim 18), which anticipates the instant claims.
Regarding claim 21, Kim teaches the compositions may comprise dispersants such as methylcellulose, inter alia, [38], which, as evidenced by Sharma, is considered an enteric polymer (abstract), which by the instant specification’s definition is a component of a targeted-release formulation (pg. 4, lines 12-14).
Regarding claim 34, Kim teaches each strain in the composition is preferably between 1 x 109 and 5 x 1012 bacteria per gram [32], which overlaps with the range recited in the claim.
Regarding claims 36-37, Kim teaches the compositions comprise L. plantarum and other probiotics such as Streptococcus thermophilus, Bifidobacterium lactis, inter alia (claim 26), which anticipates the limitations of ‘further food ingredient’ in claim 36 and “further probiotics” in claim 37.
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.
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 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (WO 2018/169297 A1) as applied to claims 18-21, 34, and 36-37 above, and further in view of Curcio et al. (Pharmaceuticals, 2020, 13, 131, pgs. 1-21, hereinafter “Curcio”).
Kim teaches the probiotic and tryptophan containing composition, and also discloses the composition can include dispersants such as methylcellulose, which is an enteric polymer that aids in targeted-release, as describe in the 102 rejection above. Kim does not teach the targeted-release formation comprises a coating of an enteric polymer such as methyl methacrylate or methacrylic acid.
However, Curcio teaches development, optimization, and characterization of Eudraguard®-based microparticles for colon delivery (title). Curcio teaches development of pH-dependent systems for colon delivery of natural active ingredients is an attractive area of research in the field of nutraceutical products, and evaluated Eudraguard® resins, that are methacrylate copolymers approved as “food grade” by European Commission and useful for the production of food supplements. In particular, Eudraguard® Biotic (EUG-B), characterized by a pH-dependent solubility and Eudraguard® Control (EUG-C), whose chemical properties support a prolonged release of the encapsulated compounds (abstract). Curcio teaches EUG-B (poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid)) is a fully polymerized anionic copolymer of methyl acrylate, methyl methacrylate and methacrylic acid, in a 7:3:1 ratio respectively (pg. 2, para 9), which is the same coating used in Example 7 of the instant specification (pg. 18), and is within % weight range recited in claims 23 and 24. Curcio teaches EUG-B in vitro tests showed a limited drug release at a gastric level and a good specific colon release (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to formulate a targeted-release preparation comprising Lactobacillus plantarum strains and L-tryptophan with an enteric polymer as taught by Kim, and coat the preparation with the sustained colonic release polymer Eudraguard biotic taught by Curcio with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to coat a capsule containing the Lactobacillus and L-tryptophan composition with the Eudraguard polymer containing methyl methacrylate, methyl acrylate, and methacrylic acid, as this coating is pH-dependent and designed to resist degradation in gastric juices to sustain a delayed colonic release, as taught by Curcio.
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claims 18-21, 34, and 36-37 above, and further in view of Shin et al. (US20230076310A1, hereinafter “Shin”), as evidenced by Huang (NCBI Accession # CP025586, Direct Submission, (29-DEC-2017) Dept. of Advanced Green Energy & Environment, Handong Global University, 558 Handong-ro, Pohang, Buk-gu 37554, South Korea).
As discussed above, Kim teaches compositions comprising Lactobacillus plantarum and L-tryptophan, characterizing the L. plantarum strains to be tryptophanase negative, which was assayed using the Kovacs reagent for indole (abstract, [24]). Kim teaches bacteria containing the tryptophanase enzyme are capable of hydrolyzing and deamining tryptophan, producing indole, pyruvic acid and ammonia, and when assayed using the indole test the following bacteria have proved to be without tryptophanase activity, specifically: S. Thermophilus, L. plantarum, L. paraplantarum, L. acidophilus, L. casei, L. paracasei, L. helveticus, B. lactis, B. breve, B.infantis, B. longum, L. lactis, L. brevis, P. Freudenreichii. [24-25]. Kim does not teach a L. plantarum subsp. argentoratensis strain that exhibits a consensus 16 rDNA sequence that is at least 95% or 99.5% identical to instant SEQ ID NO: 24. For purposes of applying prior art, the Examiner is interpreting claims 32 and 33 to require the strain to exhibit at least one of a)-f).
However, Shin teaches compositions comprising a novel Lactobacillus plantarum KC3 strain for prevention or treatment of immune impairment, respiratory inflammatory disease, allergy, and asthma (title). Shin teaches the KC3 strain is indole negative [0072], which is inherently tryptophanase negative. As evidenced by Huang, L. plantarum KC3 (NCBI Accession # CP025586.1) is 100% identical to SEQ ID NO: 24, thus meeting the limitations in claims 32-33.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to formulate a preparation comprising Lactobacillus plantarum strains and L-tryptophan as taught by Kim, and include in the composition L. plantarum KC3 strain, which is an indole negative/tryptophanase negative strain as taught by Shin. One of ordinary skill in the art would have been motivated to include the KC3 strain in the compositions taught by Kim to prepare an optimal nutraceutical and food composition comprising lactic bacteria that are unable to metabolize tryptophan, which would provide greater availability of tryptophan to the cells of the host, thus increasing control of inflammation and particularly effective in treating intestinal inflammatory diseases as taught by Kim [7-9].
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Kim, as evidenced by Diet & Fitness today (Bodyventures, 2005, <http://dietandfitnesstoday.com/tryptophan-in-cooked-egg.php>).
As described above, Kim teaches compositions comprising L. plantarum strains and foodstuff containing L-tryptophan and anticipates claims 18-21, 34, and 36-37, but does not explicitly teach a composition wherein the L-tryptophan is present in an amount of at least 10 mg.
However, Kim teaches the compositions can comprise egg, which as evidenced by Diet & Fitness today, tryptophan in egg typically ranges from 0.18 g to 0.14 g per 100g, which would be in an amount greater than 10 mg as claimed. Generally, the selection of specific concentrations clearly would have been a routine matter of optimization using standard laboratory techniques available at the time of filing on the part of the artisan of ordinary skill, said artisan recognizing that the effectiveness of the composition would have been affected by these concentrations. Therefore, would have been prima facie obvious to one of ordinary skill in the art to adjust the tryptophan levels in the composition taught by Kim for the preparation as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
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