DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-7 are pending and examined on the merits.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the application does not contain a statement that the CRF is identical to the "Sequence Listing" part of the disclosure, as described above in item 1), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide such statement.
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 1-7 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 1 is rendered indefinite by the recitation “(accession number: KCTC14360BP).” It is unclear how the term in the parentheses modifies the preceding recitation “A Lactobacillus reuteri JH53 strain.” Since claim 1 is indefinite, then the claims that incorporate it, claims 2-7, are rendered indefinite. Thus, claims 1-7 are rejected under 35 U.S.C. 112(b). This rejection can be overcome by amending claim 1 to recite “A Lactobacillus reuteri JH53 strain deposited under accession number KCTC14360BP…”
The term “excellent” in claim 1 is a relative term which renders the claim indefinite. The term “excellent organic acid resistance and conversion rate of glycerol to 1,3-propanediol” 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 term “excellent” is a subjective term used in the claim. See MPEP 2173.05(b)(IV). It is unclear what level of organic acid resistance is considered “excellent,” and it is also unclear what conversion rate of glycerol to 1,3-propanediol is considered “excellent.” Since claim 1 is indefinite, then the claims that incorporate it, claims 2-7, are rendered indefinite. Thus, claims 1-7 are rejected under 35 U.S.C. 112(b). For the purpose of applying prior art, any level of organic acid resistance and any conversion rate of glycerol to 1,3-propanediol are being interpreted as “excellent.”
Claim 2 is rendered indefinite by the recitation “the organic acid” because it is unclear whether it is referring to the organic acid for which the strain has “excellent organic acid resistance.” For the purpose of applying prior art, claim 2 is being interpreted as reciting that the strain has organic acid resistance against lactic acid or acetic acid.
Claim 3 is rendered indefinite by the recitation “(KCTC13149BP).” It is unclear how the term in the parentheses modifies the preceding recitation “a Lactobacillus reuteri CH53 strain.” This rejection can be overcome by amending claim 3 to recite “Lactobacillus reuteri CH53 strain deposited under accession number KCTC13149BP…”
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 1-7 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 organism, Lactobacillus reuteri JH53 strain deposited under accession number KCTC14360BP, is recited in the claims, and thus is essential to the claimed invention. Since the microorganism is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. §112 may be satisfied by a deposit of the biological material.
The specification does not disclose a repeatable process to obtain the microorganism, and it is not apparent if the biological material is readily available to the public. It noted that the strain has been deposited under the Budapest Treaty (Receipt in the Case of an Original Deposit issued pursuant to Rule 7.1 filed in the application on December 18, 2023), but there is no indication in the specification as to public availability of the strain.
Since the deposit was made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the specific strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
Notice Re: Prior Art Available Under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ju 2021 (Bioresource Technology. 2021. 337: 125361. 8 pages. Available online June 2, 2021).
Ju 2021 discloses Lactobacillus reuteri JH53 which has enhanced organic acid resistance and increased 1,3-propanediol (1,3-PDO) production (Highlights section on page 1). The strain is repeatedly referred to as Lactobacillus reuteri JH83 in the rest of the reference (e.g., abstract). It is evident that the JH83 strain described in Ju 2021 is the claimed JH53 strain given that the Highlights section on page 1 of the reference refers to it as the JH53 strain, and the JH83 strain possesses the same properties as the JH53 strain described in the instant specification. In particular, Ju 2021 discloses that the L. reuteri JH83 strain produces 93.2 g/L of 1,3-propanediol by fed-batch fermentation at 72 hours, which is increased by 34.6% compared to the wild-type strain (page 5, left column, first full paragraph), wherein the wild-type strain is the L. reuteri CH53 strain (page 3, right column, second paragraph). These values are identical for the JH53 strain as described in paragraph [0075] of the specification filed January 27, 2025, specifically page 21, lines 14-18. Table 1 of Ju 2021 on page 3 has the same half maximal inhibitory concentration values for the JH83 strain as the claimed JH53 strain shown in Table 4 of the specification, with respect to lactic acid, acetic acid, and total organic acid. Also, Figure 6(b) on page 7 of Ju 2021, which shows the fed-batch fermentation results of the JH83 strain in MRS medium with pure glycerol, is identical to Figure 3B of the instant specification for the JH53 strain.
Therefore, Ju 2021 anticipates instant claims 1, 2 (see Table 1 on page 3 showing lactic acid and acetic acid as organic acids, and page 3, right column, last paragraph), 3 (34.6% increase, as disclosed on page 5, left column, first full paragraph, falls in the claimed range), and 4.
Regarding instant claims 5 and 6, the JH53 strain (i.e. JH83 strain) itself is directed to the claimed ‘cosmetic composition.’ The claimed recitation of a ‘cosmetic composition’ sets forth the intended use of the composition as a cosmetic. As pointed out in MPEP 2112(I), “Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” The JH53 strain itself is suitable for use as a cosmetic since it is the active ingredient. Therefore, Ju 2021 anticipates instant claim 5. Additionally, Ju teaches that the JH53 strain (i.e. JH83 strain) was cultured in an MRS broth with glycerol (page 3, left column, second paragraph). The MRS broth inherently comprises water, so the culture of the JH53 strain in MRS broth is directed to a ‘cosmetic composition’ comprising the claimed strain and further containing water which is one of the auxiliaries recited in instant claim 6. Thus, Ju 2021 anticipates instant claim 6.
Regarding instant claim 7, the 1,3-propanediol production by fermentation, e.g. page 5, left column, first full paragraph, and page 3, left column, second paragraph of Ju 2021, is directed to producing 1,3-propanediol comprising a step of culturing the claimed strain. Thus, instant claim 7 is anticipated.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ju 2020 (Abstract of Thesis. Machine Translation, [online]. 2020 [retrieved on 2026-09-13]. Retrieved from the Internet:<https://www.dbpia.co.kr/journal/detail?nodeId=T15673717>.).
Ju 2020 discloses Lactobacillus reuteri JH53, stating it has increased 1,3-propanediol production and enhanced organic acid tolerance (page 2, first paragraph describing Chapter 4). Therefore, Ju 2020 anticipates instant claims 1 and 4.
Regarding instant claim 2, Ju 2020 does not expressly disclose that the JH53 strain has organic acid resistance against lactic acid or acetic acid (the Examiner’s interpretation of instant claim 2). However, MPEP 2112(I) indicates, “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’” The claimed organic acid resistance is a property inherently possessed by the JH53 strain. Thus, instant claim 2 is anticipated.
Regarding instant claim 3, though Ju 2020 does not expressly disclose that 1,3-propanediol production of the JH53 strain increased by 20 to 40% compared to that of a L. reuteri CH53 strain as a parent strain, the JH53 strain inherently possesses this property. As pointed out in MPEP 2112(I), “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’” Thus, instant claim 3 is anticipated.
Regarding instant claim 5, the JH53 strain itself is directed to the claimed ‘cosmetic composition.’ The claimed recitation of a ‘cosmetic composition’ is directed to the intended use of the composition as a cosmetic. As pointed out in MPEP 2112(I), “Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” The JH53 strain itself is suitable for use as a cosmetic since it is the active ingredient. Therefore, Ju 2020 anticipates instant claim 5.
Regarding instant claim 6, Ju 2020 discloses the increased 1,3-propanediol production by the L. reuteri JH53 strain under cultivation conditions of the parent strain L. reuteri CH53 (page 2, first paragraph describing Chapter 4). Jun 2020 discloses that the culture conditions of the CH53 strain use a corn soaking liquid (page 2, first paragraph describing Chapter 3). Therefore, in cultivating the JH53 strain under the cultivation conditions of the CH53 strain, then the JH53 strain is in a culture comprising a corn soaking liquid. A corn soaking liquid inherently comprises water. Therefore, the culture of the JH53 strain is directed to a ‘cosmetic composition’ comprising the JH53 strain (see preceding paragraph) and further containing water, wherein water is one of the auxiliaries recited in instant claim 6. As such, Ju 2020 anticipates instant claim 6.
Regarding instant claim 7, Ju 2020 discloses the increased 1,3-propanediol production by the L. reuteri JH53 strain under cultivation conditions of the parent strain L. reuteri CH53 (page 2, first paragraph describing Chapter 4). Therefore, Ju 2020 anticipates instant claim 7.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN EMILY FERNANDEZ whose telephone number is (571)272-3444. The examiner can normally be reached 10:30am - 7pm.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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