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/EP2023/050216 filed January 6,
2023.
In Applicant's amendment filed June 30, 2026: claims 1-16, 18, 20-27, and 30 are canceled; claims 19 and 28 are amended; and claims 31-45 are newly added.
Claims 17, 19, 28-29, and 31-45 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 17, 19 and 34-43, and species: Lactobacillus johnsonii DSM 33901, exo-inulinase, and SEQ ID NO: 1 in the reply filed on June 30, 2026 is acknowledged.
Claims 28-29, 31-33, and 44-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Claims 17, 19, and 34-43 are under examination.
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
Claim 17 is objected to because of the following informalities:
Claim 17, line 7, needs to be changed to “…after digestion of fructan and/or fructose upon .
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 40 is 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 claims contain 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 Lactobacillus johnsonii DSM 33901 or DSM 34452 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the Lactobacillus johnsonii DSM 33901. The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. 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).
Applicant’s statement on pg. 35-36 of the specification satisfies condition (a) but does not satisfying the requirements outlined in (b)-(d) above.
Claims 17, 19, 34-39, and 41-43 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.
Claims 17, 19, and 34-39, and 41-43 recite a Lactobacillus strain or a composition thereof, wherein the strain or composition is capable of: providing relief from or preventing fructan and/or fructose abdominal discomfort to a subject… and claims 41-43 recite that the composition further comprises one or more fructanases, such as endo-inulinase (EC 3.2.1.7), exo-inulinase (EC 3.2.1.80), beta-fructofuranosidase, invertase (EC 3.2.1.26) and levanase (EC 3.2.1.65)”, “where in the exo-inulinase is a polypeptide selected from the group consisting of: a. a polypeptide having at least 80% sequence identity to SEQ ID NO: 1; b. a polypeptide derived from SEQ ID NO: 1 by having 1-30 alterations, c. a polypeptide derived from the polypeptide of (a) or (b), wherein the N- and/or C-terminal end has been extended by addition of one or more amino acids, and d. a fragment of the polypeptide of (a), (b), or (c).”. The specification defines Lactobacillus strains as those that digest fructose, and may be Lactobacillus johnsonii or Lactobacillus crispatus; and the composition thereof comprises Lactobacillus strains and/or fructanases. The Specification defines fructanases as those that reduce the gas pressure in a gas pressure tests, and breaks down fructan to fructose, such as the fructan is fructo-oligo saccharides (FOS), as well as induces the growth of Bifidobacterium during hydrolysis of inulin. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. In the instant case, the specification merely gives working examples of a prescreening of 960 Lactobacillus strains for growth in the presence of fructose, wherein 13 Lactobacillus strains were selected for a kinetic growth assay in presence of fructose or FOS and inulin, and found L. johnsonii HH15 strain and L. crispatus HH22 strain showed good growth on fructose, FOS, and glucose. The specification gives working examples of testing a multicomponent product comprising enzymes according to SEQ ID NO’s: 1-3, bacterial fructanase BacTop, and inulinase P and tested in a pressure measurement assay, then tested the HH15 or HH22 strain in different mixtures comprising an enzyme and/or substrate in human fecal samples. and are the only species whose complete structure is disclosed. While the genus encompasses a large number of variants that have the same activity as Lactobacillus strains, fructanase enzymes, and compositions thereof that aid in fructan and/or fructose digestion, in kind and the genus encompasses a large number of variants that have a different structure, the specification does not describe the complete structure of a representative number of species of the large genus of Lactobacillus strains, fructanase enzymes, and compositions thereof that aid in fructan and/or fructose digestion variants or functional equivalents thereof. Additionally, the specification does not describe the complete structure of a representative number of species of the large genus of variants and/or fragments of an exo-inulinase, only describing variant identity as being between 80-99% identical or similar to the protein of interest, or derived from SEQ ID NO: 1 having 1-30 alterations, including substitutions, deletions, and/or insertions.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus."
Claim 43 recites “a polypeptide having at least 80% sequence identity to SEQ ID NO: 1, or a polypeptide derived from SEQ ID NO: 1 having 1-30 alterations…or a fragment of the polypeptide…”. Thus, the claims require a polypeptide having the aforementioned activity with at least 80% sequence identity to SEQ ID NO: 1, or with 1-30 alterations, or a fragment thereof. However, the specification has failed to sufficiently describe the structural features that must be retained by members of the claimed genus as to establish a structure-function relationship with respect to the activity. For example, SEQ ID: 1 is 518 amino acids long. A protein sharing only 80% identity relative to SEQ ID: 1 could have anywhere from 1 to 103 substitutions, deletions or additions in any combination along any length of SEQ ID: 1. Thus, an enormous genus (20102 = 5.0 x 10132) comprising literally more than trillions of sequences is encompassed by the tremendously broad scope of the claims.
However, while the claims are drawn to a genus that comprises literally trillions of sequences, the specification has only adequately described and successfully reduced to practice the full-length of SEQ ID NO’s: 1-3. This is not representative of the extremely large genus of sequences claimed, since only two other variants of SEQ ID NO: 1 is demonstrated to have fructanase activity. At best, the specification contemplates the use of the Needeman-Wunsch algorithm to identify functional homologs based on sequence homology. However, this is not sufficient to describe members of the claimed genus because such methods access online databases that are continually being updated as sequencing technology improves. As a result, they are not a static source of information. Thus, one of skill in the art would readily appreciate that relying on a non-patent source that is continuously subject to change as a means to identify members of the claimed genus does not sufficiently meet the written description requirement.
Moreover, Friedberg (Brief. Bioinformatics (2006) 7: 225-242) teaches that homology-based transfer is not reliable for functional annotation even with high alignment percentages (page 227, second column). Friedberg also teaches that identification of functionally significant sub-regions is critical to functional annotation, and that often addition, deletion, or re-shuffling of domains can lead to errors in annotation (page 227, second column, page 228, first paragraph). Furthermore, Friedberg teaches that sequence-based tools are just not sensitive enough to identify functional protein similarity as databases get larger, and diversity of sequences gets larger (page 228, first full paragraph).
Thorton et al. (Nature structural biology, structural genomics supplement, November 2000, pgs. 991-994) teaches that the same protein structure is often seen in apparently different homologous families with different functions. Thorton et al. further describe examples of little correlation between specific enzyme function and overall protein structure (see page 992, right column, at lines 2-10).
Thus, when taken with the teachings of Friedberg and Thorton, one of skill in the art would readily appreciate that sequence homology alone cannot serve as the basis to describe members of the genus that have the recited function.
In the absence of a representative number of examples and any art-recognized structure-function relationship, the specification must at least describe the structural features that are required for the claimed function, in this case to the aforementioned activities. However, as discussed above, the specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to the activities. Instead, Applicant merely offers a statement that any polypeptide having the intended activity will work.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genera at the time of filing.
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 17, 19, and 34-43 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 17 recites “A Lactobacillus strain or a composition thereof, wherein the strain or composition is capable of:…”, which is indefinite because the scope of “a composition thereof” is unclear. In particular, it is unclear whether ‘thereof’ requires the composition to comprise the Lactobacillus strain or encompasses a composition comprising a component or product derived from the Lactobacillus strain without comprising the strain itself. The subsequent recitations that ‘the strain or composition’ is capable of the claimed functions does not resolve the relationship required between the Lactobacillus strain and the alternatively claimed composition, thus the metes and bounds of the claimed ‘composition thereof’ cannot be determined.
The term “abdominal discomfort” in claim 17 is a subjective term which renders the claim indefinite. The term “abdominal discomfort” is not defined by the claim, the
Specification does not provide some objective standard in order to allow the public to
determine the scope of the claim. The claim is unclear because there is no objective boundary for determining what degree or type of change in abdominal discomfort constitutes ‘relief’, thus one of ordinary skill in the art would not be reasonably apprised of which Lactobacillus strains satisfy this limitation. Similarly, the term “preventing…abdominal discomfort” is likewise ambiguous/unclear, since the interpretation could mean completely preventing symptoms or reducing their incidence, or reducing their severity relative to an untreated subject.
The term “”improving digestion” in claim 17 is a relative term which renders the claim indefinite. The term “improving digestion” 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. It is unclear what degree of digestion constitutes ‘improving’ and relative to what baseline such improvement is determined. Thus, the metes and bounds of the claimed strain or composition cannot be determined with reasonable certainty.
The term “providing digestive comfort” in claim 17 is a subjective term which renders the claim indefinite. The term “providing digestive comfort” is not defined by the claim, the specification does not provide some objective standard in order to allow the public to determine the scope of the claim. “Providing digestive comfort” is not objectively bounded, and introduces ambiguity around what constitutes digestive comfort, such as absence of bloating, less gas, less pain, normal bowl movements, or some other undefined subjective feeling.
Claim 17 recites “…providing digestive comfort after digestion of fructan and/or fructose on consumption of products containing fructan and/or fructose to a subject;”. It is unclear whether ‘after digestion’ modifies providing digestive comfort, whether ‘on consumption’ modifies digestion, or whether the intended limitation is simply digestive comfort following consumption of a fructan/fructose containing product. Thus, this limitation is indefinite because it is grammatically and/or temporally unclear.
Claim 19 recites “at least 20-50% reduction of gas pressure development” which is indefinite because it is unclear whether the claimed reduction is at least 20%, is limited to the range of 20-50%, or is at least 50%. The term ‘at least’ in conjunction with the bounded range fails to provide a reasonably certain boundary for the claimed degree of reduction.
Claim 19 recites the limitation "the fiber alone" in 9. There is insufficient antecedent basis for this limitation in the claim.
The term “across different donors” in claim 19 is a relative term which renders the claim indefinite. The term “across different donors” 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. The limitation introduces ambiguity as to what constitutes a ‘different donor’ and how many donors are required as an average or a majority that the 20-50% reduction would have to occur.
The term “reduces gas production” in claim 34 is a relative term which renders the claim indefinite. The term “reduces gas production” 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. It is unclear what ‘reduces’ necessarily implies, such as a comparison, however the claim doesn’t say what the gas production is reduced relative to. Similarly, claim 35 recites “reduces at least 20% gas production” which is relative and does not provide a value to serve as the denominator/control for calculating the 20% reduction.
Claim 34 recites “…fecal matter induced with fructan and/or fructose” which is ambiguous and does not clearly define what is being done to the fecal matter or what is exactly induced, such as gas production resulting from fermentation of fructan and/or fructose by the fecal matter, or gas production in fecal matter supplemented with fructan and/or fructose, thus is indefinite. Similarly, this term is recited in claim 35.
Claim 43 recites “…d. a fragment of the polypeptide of (a), (b), or (c).”, which is indefinite because neither the claims nor the specification give any objective bounds to what a ‘fragment’ constitutes, such as minimum length and/or if it is required to retain exo-inulinase activity. Similarly, the limitations “b. a polypeptide derived from SEQ ID NO: 1 by having 1-30 alterations” and “c. a polypeptide derived from the polypeptide of (a) or (b)” also lacks objective boundaries since ‘derived from’ can be in terms of deriving from the entire referenced sequence or may instead be derived from only a portion thereof. Thus, the claim does not reasonably apprise one of ordinary skill in the art of the structural relationship required between the claimed polypeptide and the referenced sequence.
Claims 36-42 are likewise rejected as being dependent on an indefinite claim.
Claim Interpretation
Claims 17, 19, and 34-43 recite “A Lactobacillus strain or a composition thereof” but as described above in the 112(b) rejection, ‘a composition thereof’ is not completely defined in the claims nor specification. For purposes of applying prior art, the Examiner interprets ‘a composition thereof’ to mean a composition comprising a Lactobacillus strain or metabolites/enzymes derived from said strain that have the recited functions in the claims.
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 17, 19, and 34-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product 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 17, 19, and 34-43 recite Lactobacillus strain or composition thereof, wherein the Lactobacillus strain is Lactobacillus johnsonii with deposit number DSM 33901 and compositions comprising the Lactobacillus strain and fructanases, which is a statutory category of invention (Step 1: Yes).
Claims 17, 19, and 34-43 are drawn to a Lactobacillus strain that aids in digestion of fructan and/or fructanase and may include fructanases in the composition. The Specification discloses screening 960 Lactobacillus strains to determine beneficial impact on the gut, and fructanase enzymes, such as exo-inulinase having the mature amino acid sequence of SEQ ID NO: 1. As evidenced by Haridas et al. (NCBI Accession # XP_026623446.1, Direct Submission, Submitted (25-JUL-2018), DOE Joint Genome Institute, 2800 Mitchell Drive, Walnut Creek, CA 94598-1698, USA), a glycoside hydrolase family 32 protein from Aspergillus welwitschiae isolated from the Welwitschia mirabilis plant in Nigeria has 97% identity to instant SEQ ID NO: 1, thus the claims are broad to include naturally occurring enzymes. There is no evidence that this particular exo-inulinase enzyme or L. johnsonii HH15 strain with deposit number DSM 33901, have any markedly different characteristic from other exo-inulinase enzymes or L. johnsonii strains, nor that these have been genetically modified or altered that would enhance functionality in the ability for providing digestive discomfort or aiding in digestion of fructan and/or fructose. Therefore, the Lactobacillus strains and fructanases claimed are naturally occurring organisms and/or enzymes, that is a judicial exception in the form of being a product of nature (Step 2A, Prong 1: Yes).
Claims 34-35 recite the Lactobacillus strain or composition thereof reduces gas production of fecal matter induced with fructan and/or fructose in a gas pressure measurement system. However, these are merely inherent characteristics of the strain, wherein these particular qualities are characterized by routine and well-understood laboratory practices, thus do not integrate the claims into a practical application. Furthermore, the claims recite generic compositions that are ‘capable of’ providing relief from abdominal discomfort caused by fructan and/or fructose, but do not recite a particular application of the compositions, thus the claims do not recite additional elements that integrate the judicial exception 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 17, 19, and 34-43 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 17, 19, 36, 38-39, and 41-43 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Liu (WO2022/020665A2, cited in IDS filed 7/3/2024), as evidenced by Loponen et al. (US20190174773A1, hereinafter “Loponen”).
Regarding claims 17, 19, 36, 39, and 41-43, Liu teaches food supplement compositions to aid in digestion of fructan, mannitol, and sorbitol that reduce symptoms of digestive conditions caused by ingestion of FODMAPs (fermentable oligo-, di-, monosaccharides, and polyols) (title, abstract, [0004]). Liu teaches the composition comprises at least one fructan-degrading enzyme, such as an exo-inulinase, wherein the exo-inulinase has at least 80% identity to SEQ ID NO’s: 7 and 30 (claims 1, 14, & 18). Liu teaches SEQ ID NO: 7 is derived from Lactobacillus crispatus, which the Examiner interprets as a ‘composition thereof’ in relation to a Lactobacillus strain, thus anticipating claims 17 and 41-42 ([0059], Table 2, claims 1-12, 14, and 18). Furthermore, Liu teaches SEQ ID NO: 30 has 93.7% identity to instant SEQ ID NO: 1, thus anticipates claim 43 (See sequence comparison below).
Regarding the functional limitations recited in claims 17, 19, and 36, Liu teaches experiments performed on a healthy individual consistently show remarkable reduction in symptoms when enzyme is used compared to control [00235], and exo-inulinase was administered with shallots fried in oil (a high-fructan food), and the subjects proceeded to track symptoms for the next twelve hours, such as magnitude of flatulence, abdominal pain and/or discomfort, and bloating [00236]. Subjects administered the exo-inulinase reported no symptoms and a reduced instances of flatulence, which inherently anticipates the functional limitations of the claimed compositions recited in the claims. Liu teaches reported flatulence in the subjects administered exo-inulinase had 10 total instances, wherein the placebo group had 30, which results in a 66% reduction of gas development when compared with the controls ([00238], Table 11), thus anticipating the at least 20-50% reduction of gas pressure development in claim 19.
Regarding claim 38, Liu teaches the L. crispatus strain DSM 29598 is characterized in US Patent Publication 2019/0174773 [0059]. As evidenced by Loponen, L. crispatus DSM 29598 was effective in hydrolyzing fructan and further use the possible degradation products and metabolites (fructose, FOS, mannitol) for growth, thus this strain is inherently capable of growth on fructose in vitro [0045]-[0047].
Liu’s SEQ ID NO: 30 and instant SEQ ID NO: 1
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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 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied to claims 17, 19, 36, 38-39, and 41-43 above, and further in view of Zhao et al. (J. Anim. Sci. 2013.91:5280–5286, hereinafter “Zhao:).
As described above, Liu teaches a composition derived from metabolites from a Lactobacillus strain resulted in reduced abdominal discomfort due to fructan digestion. Liu teaches reported flatulence in the subjects administered exo-inulinase (derived from Lactobacillus strains) had 10 total instances, wherein the placebo group had 30, which resulted in a 66% reduction of gas development when compared with the controls ([00238], Table 11).
Liu does not teach the gas production was measured in a gas pressure measurement system.
However, Zhao teaches evaluation of fructan supplementation on growth performance, nutrient digestibility, meat quality, fecal microbial flora, and fecal noxious gas emission in finishing pigs (title). Zhao teaches fresh feces and urine samples were collected randomly from at least 2 pigs in each pen on the last 2 d of the experiment, and the samples were permitted to ferment for 7 d at room temperature (25⁰C), wherein concentrations of gas were determined on d 1, 3, 5, and 7 during the fermentation period by a gas sampling pump was utilized for gas detection (pg. 5282, col. 1, para 3). The feces from the pigs administered fructan were evaluated for noxious gas emissions and microbial population compositions, and found fructan supplementation decreased E. coli and increased Lactobacillus concentration in feces, and also resulted in lower H2S and NH3 emissions compared with controls (pg. 5283, col. 1, para 1, Table 5). Zhao teaches at day 3, H2S production was reduced by 19.6% in the FC2 fructan supplemented group compared with controls (pg. 5284, Table 5). Although the noxious gas production with fructan stimulated feces was not reduced by at least 20%, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to formulate a composition comprising exo-inulinase from a Lactobacillus strain that shows reduced flatulence (i.e. gas production) in vivo as taught by Liu, and combine with fecal matter stimulated with fructan in a gas pressure measurement system to determine the composition’s ability to reduce gas production as taught by Zhao. One of ordinary skill in the art would have been motivated to formulate a composition that reduces gas production in vivo and in vitro to determine the composition’s fructan degrading ability, which can be applied in improving digestion in healthy individuals as taught by Liu (claim 99).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied to claims 17, 19, 36, 38-39, and 41-43 above, and further in view of Helena et al. (US 2016/0375069 A1, cited in IDS filed 7/3/2024, hereinafter “Helena”).
As described above, Liu teaches a composition comprising exo-inulinase derived from a Lactobacillus strain resulted in reduced abdominal discomfort due to fructan digestion, thus anticipates claims 17, 19, 36, 38-39, and 41-42. Liu teaches the composition can further comprise a live probiotic microbe, including Lactobacillus plantarum [00136].
Liu does not disclose the composition comprises a Lactobacillus strain that is capable of surviving in the gastrointestinal tract.
However, Helena teaches Lactobacillus strains that can be used to produce pharmaceutical products with probiotic properties, for treating disorders related to fructose malabsorption, intolerance, and bloating (abstract). Helena teaches growth rates of different Lactobacillus strains with fructose supplementation, and found Lactobacillus plantarum KR6 had a 88% growth rate with fructose and no gas production during growth (pg. 6, Table 1). Helena teaches the KR6 strain had good survival on low pH and intestinal juice (pg. 7, Example 5). Helena teaches the strains according to this invention consume fructose, lactose, and raffinose while not producing gas [0002].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective date of the claimed invention to formulate a composition that aids in fructan digestion as taught by Liu, and further include a Lactobacillus plantarum strain that is capable of surviving in the gastrointestinal tract as well as metabolizing fructose as taught by Helena. One of ordinary skill in the art would have been motivated to formulate a composition that includes a fructan degrading enzyme and live Lactobacillus strain that can degrade fructose and survive in the gastrointestinal tract to aid in digestion of FODMAP foods as taught by Liu, and also decrease fructose concentration in the intestines, wherein elevated fructose concentrations result in increased osmotic pressure and reduced water absorption as taught by Helena [0004].
Conclusion
There is no prior art teaching Lactobacillus johnsonii strain HH15 with deposit number DSM 33901, nor Lactobacillus crispatus strain HH22 with deposit number DSM 34452.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
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