DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group II, claims 3 and 4, in the reply filed on 4/7/26 is acknowledged.
Claims 1, 2 and 5-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Objections
Claims 3 and 4 are objected to because of the following informalities: the claims depend from a non-elected claim. Claim 3 needs to be rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112-2nd paragraph
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 3 and 4 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.
Clam 3 is vague and indefinite because it recites:
“A method for intestinal permeability and metabolic disorders by using the probiotic composition” and the wording is unclear. Do Applicants intend to mean ‘a method for treating intestinal permeability and metabolic disorders”? The use of the phrase “for” does not clearly state that intention. Additionally, it is unclear what is meant “by using.” This phrase does not clearly describe what that entails. Is this an administration step or something different? The method claim should clearly describe how the probiotic is used, e.g., by administering, etc. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claims 3 and 4 are also unclear due to the phrase “and/or its metabolites” (from claim 1 from which they depend) because it is unclear what these encompass. The metes and bounds of the term are not readily understood. A metabolite may be any amino acid or a vitamin or pigment, etc. Accordingly, it is unclear what is being claimed. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 112-Deposit Requirement
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 3 and 4 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of strain Lactobacillus helveticus UA881 strain (NITE-BP-03802). Because it is not clear that the properties of the strain are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the plasmids, a suitable deposit for patent purposes is required.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
© the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become non-viable or non-replicable.
In addition, a deposit of the biological material that is capable of self-replication either directly or indirectly must be viable at the time of the deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1)The name and address of the depository;
2)The name and address of the depositor;
3)The date of deposit;
4)The identity of the deposit and the accession number given by the depository;
5)The date of the viability test;
6)The procedures used to obtain a sample if the test is not done by the depository; and
7)A statement that the deposit is capable of reproduction.
If the deposit was made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by Applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when a deposit is made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and address of the depository is required.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 112-Scope of Enablement
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 3 and 4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A method for protecting the intestinal permeability and treating metabolic disorders by administering to a subject an effective amount of a probiotic composition comprising Lactobacillus helveticus UA881 strain (NITE-BP-03802).
, does not reasonably provide enablement for:
A method for intestinal permeability and metabolic disorders by using any metabolite/metabolites of Lactobacillus helveticus UA881 strain (NITE-BP-03802).
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The examples provided in the instant specification evaluated the metabolic and gut microbiota-modulating effects of Lactobacillus helveticus (UA881) as a probiotic in subjects. The primary endpoint, serum triglycerides, was significantly decreased,
and the increases in uric acid, total cholesterol, and Low-density lipoprotein-cholesterol (LDL-C) observed in the placebo group were attenuated. See Figures 1-8 and Examples. However, ‘metabolites’ were not shown. The examples show that subjects received the UA881 strain. Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Primary metabolites: Directly involved in normal growth, development, and reproduction. They are essential for basic cellular functions and are produced in large quantities during active growth. Examples include:
Amino acids (e.g., glutamic acid, aspartic acid)
Nucleotides (e.g., guanosine monophosphate)
Organic acids (e.g., acetic acid, lactic acid)
Ethanol (in fermentation)
Vitamins (e.g., B vitamins, vitamin K) Wikipedia
Secondary metabolites: Not directly involved in growth or reproduction, but often serve ecological roles such as defense, signaling, or competition. Examples include:
Antibiotics (e.g., penicillin, streptomycin)
Pigments (e.g., melanin, carotenoids)
The instant specification does not show that any single ‘metabolite’ as encompassed by the art recognized terms above, would possess the same functional ability as the UA881 strain.
Claim Rejections - 35 USC § 102 or 103
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.
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Brucelin et al (US 20110189149).
Brucelin et al teach lactic acid bacteria to treat diabetes, insulin resistance, blood glucose, etc., (metabolic disorders). See abstract.
[0061] In the present invention, the bacteria used may be of the same type (genus, species and strain) or may comprise a mixture of genera, species and/or strains.
[0062] Suitable lactic acid bacteria may be selected from the genera Lactococcus, Lactobacillus, Leuconostoc, Camobacterium, Enterococcus, Propionibacterium, Pediococcus, and Streptococcus and mixtures thereof. Typically, the lactic acid bacteria are selected from the species Leuconostoc spp., Lactococcus cremoris, Lactococcus lactis, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus kefiri, Lactobacillus bifidus, Lactobacillus brevis, Lactobacillus helveticus, Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus curvatus, Lactobacillus bulgaricus, Lactobacillus sakei, Lactobacillus reuteri, Lactobacillus fermentum, Lactobacillus farciminis, Lactobacillus lactis, Lactobacillus delbreuckii, Lactobacillus plantarum, Lactobacillus paraplantarum, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus johnsonii and Lactobacillus jensenii, and combinations of any thereof.
Paragraph [0112] teaches the use of a food product, dietary supplement or medicament for treating metabolic syndrome in a mammal.
The reference teaches compositions comprising L. helveticus for treatment. Although Brucelin do not specifically recite the strain is UA881 strain, given the bacteria are the same Genus/species, the disclosed L. helveticus of the prior art reference appears to be identical to Applicants' L. helveticus given the identity of the source and the same functional abilities. If the claimed strain and the strain of the prior art are not the same, they appear to be obvious or analogous variants of the claimed proteins because they appear to possess the same or similar functional characteristics. Since the Patent Office does not have the facilities for examining and comparing Applicant's strain with the strain of the prior art, the burden of proof is upon applicants to show an unobvious distinction between the material structural and functional characteristics. See In re Best, 195 USPQ 430, 433 (CCPA 19&&). It is noted that the instant claims also include the broad description of “any of its metabolites” which would also read on the strain of the prior art as the full-length strain is not required.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Cudennec et al (US 20230025631; January, 26, 2023).
Cudennec teaches probiotics in a method of treating a disease or disorder comprising administering to a subject in need thereof a therapeutically effective amount of lactic acid bacteria, wherein the disease or disorder is linked to a deficiency in the intestinal absorption of calcium or is an abnormal physiological condition linked directly or not to a dysfunction of the vitamin D receptor, the TRPV6 transporter or a deregulation of the mechanisms of cellular signaling involving calcium, in particular apoptosis and cell proliferation. The disease or disorder is osteoporosis, type 2 diabetes, hypertension, cardiac pathologies linked to blood calcium, obesity or metabolic syndrome. See claims.
Paragraph [0046] The present invention also relates to a composition selected from food or pharmaceutical compositions characterized in that it contains the strain according to claim 1 and the strain of Lactobacillus helveticus VFH049 deposited at the CNCM under order number CNCM-I-5403.
The reference teaches compositions comprising L. helveticus for treatment. Although Cudennec do not specifically recite the strain with the same name, e.g., UA881 strain, given the bacteria are the same Genus/species, the disclosed L. helveticus of the prior art reference appears to be identical to Applicants' L. helveticus given the identity of the source and the same functional abilities. If the claimed strain and the strain of the prior art are not the same, they appear to be obvious or analogous variants of the claimed proteins because they appear to possess the same or similar functional characteristics. Since the Patent Office does not have the facilities for examining and comparing Applicant's strain with the strain of the prior art, the burden of proof is upon applicants to show an unobvious distinction between the material structural and functional characteristics. See In re Best, 195 USPQ 430, 433 (CCPA 19&&). It is noted that the instant claims also include the broad description of “any of its metabolites” which would also read on the strain of the prior art as the full-length strain is not required.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 6/5/26
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