DETAILED ACTION
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 .
Status of Claims
Claims 1-3 are pending.
Specification
The disclosure is objected to because of the following informalities: the nucleotide sequences at page 8, paragraphs [0052-53] are not followed by a proper sequence identifier. 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.
Claims 1 and 2 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 Lacticaseibacillus rhamnosus DY801. Because it is not clear that bacterial cell lines possessing the properties of Lacticaseibacillus rhamnosus DY801 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 Lacticaseibacillus rhamnosus DY801, a suitable deposit for patent purposes is required. Accordingly, filing of evidence of the reproducible production of the bacterial cell line claimed in claims 1 and 2, is required. Without a publicly available deposit of the above cell line, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the bacterial cell line is an unpredictable event. Applicant's referral to the deposit of the bacterium Lacticaseibacillus rhamnosus DY801 on pages 2-3, paragraph [0007] of the specification is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR §1.801-1.809 have been met.
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 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 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 deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. The viability statement from the depository does not unequivocally state that the deposit was made under the provisions of the Budapest Treaty. The viability statement provides for “based upon” language which does not meet all the provisions of the Budapest Treaty.
If the deposit has 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;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of 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 nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of 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.
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 hybridoma 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 Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
It is noted that the Viability statement and deposit declaration filed 4-4-2024 is insufficient to meet all the above cited criteria for a deposit that has not been made under the provisions of the Budapest Treaty. Additionally, the deposit declaration as filed does not meet the formal requirement regarding willful false statements and stat that all statements made are true. 37 CFR 1.68 permits a declaration to be used instead of an affidavit. The declaration must include an acknowledgment by the declarant that willful false statements and the like are punishable by fine or imprisonment, or both (18 U.S.C. 1001) and may jeopardize the validity of the application or any patent issuing thereon. The declarant must set forth in the body of the declaration that all statements made of the declarant’s own knowledge are true and that all statements made on information and belief are believed to be true.
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 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception without significantly more.
Instant claim 1, as amended, and claim 2 are directed to a bacterium Lacticaseibacillus rhamnosus DY801and a composition comprising the bacterial strain Lacticaseibacillus rhamnosus DY801. Because the claimed strain and composition comprising such are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of instant claims is directed to a statutory category, i.e., a composition of matter (Step 1: YES). The as-filed specification at page 6, paragraph [0041] to page 42, paragraph [0042] documents that the claimed bacterium strain of the invention encompasses strains isolated from a naturally occurring source, i.e., from nature. Therefore, the claimed strain is a naturally occurring strain. There is no evidence that the claimed Lacticaseibacillus rhamnosus DY801 bacterium strain is modified in any way and the strain is markedly different from what exist in nature. Supreme Court has made it clear in Myriad that eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature. Unlike the Chakrabarty bacterium, which was new “with markedly different characteristics from any found in nature” Diamond v. Chakrabarty, 447 U.S. 303 (1980) at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the multiple additional plasmids and resultant “capacity for degrading oil”, there is no indication that the instantly claimed strain are genetically manipulated or structurally modified in any marked or significant way such that the structural difference results in change of properties of the strain. Furthermore, the bacterial characteristics as described in the specification or claimed represent the inherent qualities, properties or characteristics inseparable from said naturally occurring strain(s) and therefore are a handiwork of nature. In Chakrabarty and Myriad, the marked difference inquiry was focused on the modified structural characteristics of the product, not how it was used or how it was made. Note that “….. patents cannot issue for the discovery of phenomena of nature”. Le Roy v. Tatham, 14 How. 156, 175 (1853). The qualities of the bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.” See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. at 130, 1948. In Funk Brothers, the Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. In the instant case, a composition having Lacticaseibacillus rhamnosus DY801 bacterium does not add significantly more to the natural products such that it is practically applied. Thus, each component of the instantly claimed product is a ‘product of nature’ exception, and the claims are directed to a judicial exception (Step 2A Prong One: YES). Judicial exceptions include all natural products including those derived from natural sources or patients such as naturally occurring microorganisms, proteins, peptides, glycoproteins, glycopeptides, carbohydrates, and other substances found in or derived therefrom, or from nature. Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claims amount to significantly more than the exceptions. Having the naturally occurring strain in a composition does not amount to significantly more. There is nothing that provides significantly more or that integrates the claimed naturally occurring strain i.e., the judicial exceptions, into a practical application (Step 2A Prong Two: NO). No elements or claim limitations apply or use the exception(s) in any meaningful way and integrate the law of nature into a practical application. The limitation ‘composition’ merely indicates a field of use in which to apply the judicial exceptions and therefore fail to provide meaningful limits on the claims. The claims as a whole do not amount to significantly more than ‘products of nature’ (Step 2B: NO). Therefore, the claims are not directed to a patent eligible subject matter.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to judicial exception e.g. a natural product, a naturally occurring nucleotide sequence.
The claimed invention is directed to non-statutory subject matter the claims are drawn to a naturally DNA segment (nucleotide sequence) from Lactocaseibacillus rhamnosus DY801 that the specification teaches uniquely identifies the DY901 strain from other strains of Lactocaseibacillus rhamnosus. (see teachings of specification indicating that these are fragments of known naturally occurring polypeptides (orfs)). The nucleic acid sequence of the claim is not isolated from nature and does not reflect the “hand of man” in its isolation. Even if it was isolated and/or purified, the isolation/purification or fragmentation does not confer a marked structural difference from the naturally occurring product. Even though the nucleotide sequence appears to be fragments of naturally occurring sequence, it is not markedly different. Eligibility requires more than the description of a sequence and the isolation by the hand of man. To be eligible the claimed product must be both non-naturally occurring and markedly different from naturally occurring products. In the instant case, the claimed nucleotide sequence does not markedly structurally differ from that found in nature whose sequence comprise the claimed nucleotide sequence as shown in SEQ ID NO:1. The removal of the isolated fragment from the intact naturally occurring bacterial chromosome does not provide a marked structural difference of the fragment from that which is naturally occurring. The isolation/purification or synthesis of the fragment does not confer a marked difference on the nucleotide sequence per se. As such, the claimed product is not patent eligible see analgous rationale in Association for Molecular Pathology v Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013)) set forth for isolated nucleic acids. Any composition comprising the isolated polypeptide fragment does not meet the criteria as it merely combines the isolated polypeptide fragment with naturally occurring elements. The term “recombinant” also would not confer a structural difference with respect to the naturally occurring sequence as the means of producing the nucleotide sequence does not appear to confer a marked structural difference from the naturally occurring structure/sequence. There are no other elements recited in addition to the judicial exception of a naturally occurring nucleotide sequence or fragment thereof and as such the claim is drawn solely to the judicial exception and it is not incorporated into a practical application.
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 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yi et al (CN115927106A;4-7-2023; google English translation).
Yi et al teach SEQ ID NO:1 from Lactocaseibacillus rhamnosus DY801 (see alignment). Wen et al teach Lactocaseibacillus rhamnosus DY801 and compositions comprising such (see Google translation page 1, abstract and page 2, claims). As such, Yi et al anticipate the claimed invention.
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Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yi et al (CN115927106B; 9-8-2023; google English translation).
The teachings of Yi et al are the same as for CN115927106A above. As such, Wen et al anticipate the instantly claimed invention.
Claim 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wen et al et al Accession Number BMR83399, May 18, 2023.
Wen et al teach SEQ ID NO:1.
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Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al (Gut, 72:(Suppl 1) special issue ppA73 June 10-11, 2023).
Yu et al teach the bacterium Lactobacillus rhamnosus DY801 which is the same as the instant Lacticaseibacillus rhamnosus DY801 as claimed. Yu et al teach the isolation and characteristics of the bacterium and its use in the treatment of acute radiochemotherapy-induced intestinal injury (see methods and abstract). Lactobacillus rhamnosus is the old taxonomy nomenclature for the organism now known as Lacticaseibacillus rhamnosus. As such, Yu et al anticipates the instantly claimed invention.
Conclusion
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/Patricia Duffy/Primary Examiner, Art Unit 1645