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 1-6 are pending.
Sequence Requirements
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 C.F.R. § § 1.821-1.825 for the reason(s) set forth below and on the attached PTO-2301.
Applicant’s attention is directed to paragraphs [63] and [70] (Table 1). Full compliance with the sequence rules is required in response to this office action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, since the priority document is not in English, the date for prior art purposes is the international filing date of 3/31/2022.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2 and 6 in the reply filed on 11-10-2025 is acknowledged.
Claims 3-5 are withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement filed 7-21-25 has been considered. An initialed copy is enclosed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1, 2 and 6 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.
As to claims 1, 2 and 6 the specification lacks complete deposit information for the deposit of Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP) at paragraph [82] and [103-106] of the specification. Because it is not clear that cell lines possessing the properties of Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP) 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 Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP), a suitable deposit for patent purposes is required. A deposit declaration filed 9-28-2023 has been received however it lacks identification in English indicating that the deposit was or was not made under the Budapest treaty.
Accordingly, filing of evidence of the reproducible production of the bacterium claimed in the claims is required. Without a publicly available deposit of the above bacterium, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the bacterium is an unpredictable event. Applicant's referral to the preservation of the Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP) in the China Center for Type Culture Collection on March 29, 2021 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 (1) deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, (2) that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and (3) 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. Amendment of the specification to recite the date of 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;
(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.
Additionally, claims 1, 2, and 6, the claims require that the Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP) strain of bacterium has plastic-degrading activity including the ability to degrade one or more of polyethylene terephthalate (PET), polyvinyl chloride (PVC), polystyrene (PS), polypropylene (PP), and polyethylene (PE). The specification teaches that Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP) has the ability to degrade polystyrene (PS) by means of a hydroxylation reaction performed by alkane monooxygenase of alkB. No other plastics were tested or examined. Inasmuch as the other plastics have different structures, one skilled in the art would be unable to predict which, if any, other plastics would be degraded by the bacterium. The skill artisan would have to test each type of plastic individually to see if the bacterium would digest or provide degradation. No particular guidance is provided for analysis of degradation of other plastics in the as filed specification. No starting materials and no particular methods of analysis are disclosed or pointed to. It is not clear that the polystyrene methods directly apply to other plastics with variant structures, properties and characteristics. The skilled artisan would have to randomly select plastics, polymers and methods of analysis to determine if the bacterium possess the claimed degrative properties. Such a search would be made without any reasonable expectation of success as no other microorganism within the genus and species has been apparently been demonstrated to have the degrading properties as claimed. See Rasmussen v. SmithKline Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir. 2005) “If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the ‘inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked.” However, in applications directed to inventions in arts but where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work. The claims are not enabled for the genus of “plastics” nor the other claimed species of plastic, with the exception of polystyrene (PS).
For all the foregoing reasons the claims are not enabled.
Claims 1, 2 and 6 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.
As to claim 1 and every claim dependent thereon (2 and 6), the inclusion of the Accession No. in parenthesis is indefinite since it is unclear if the claim is limited to the strain having the particular Accession No..
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim recites wherein the plastic includes one or more of polyethylene terephthalate (PET), polyvinyl chloride (PVC), polystyrene (PS), polypropylene (PP), and polyethylene (PE). These are mere characteristics of the strain of bacterium and do not further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a bacterium without significantly more. The claim(s) recite(s) “A Bacillus sp. producing a bioflocculant and a biosurfactant, wherein the microbial classification of the Bacillus sp. is named Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP). This judicial exception is not integrated into a practical application because it is drawn to a naturally occurring product the Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP), per se. The specification teaches at paragraph [0007] that the Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP) of the present application comes from the soil in in Chonnam National University in Gwangju Korea or barns (see paragraph [24]). The claimed Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP), is a naturally occurring bacterium that has been isolated from nature. The stated properties of degrading one or more polyethylene terephthalate (PET), polyvinyl chloride (PVC), polystyrene (PS), polypropylene (PP), and polyethylene (PE) plastics are mere characterization of the properties of the naturally occurring bacterium. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it claims properties/characteristics that are inherently present in the Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP) and have not been manufactured or artificially placed therein.
The as-filed specification at paragraph [24-26] is 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 Pseudomonas lini JNU 01 (Accession No. KCTC 14425BP) strain is modified in any way and the strain(s) are markedly different from what exist in nature. Supreme Court has made it clear in Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014 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(s) 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(s). Furthermore, the ability to degrade plastic and polyethylene terephthalate (PET), polyvinyl chloride (PVC), polystyrene (PS), polypropylene (PP), and polyethylene (PE) in particular as recited 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. 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. There is nothing that provides significantly more or that integrates the claimed naturally occurring strain into something more. 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 claim as a whole does not amount to significantly more than a product of nature. 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 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.
Claim(s) 1, 2 and 6 are rejected under 35 U.S.C. 102(a)(1) being anticipated by Kim et al (Journal of Hazardous Martials, 416:12639 pages 1-9, on line May 27, 2021).
Kim et al teach Pseudomonas lini JNU01 (see abstract). Kim et al teach that P. lini JNU01 provided for growth and degradation of polystyrene (see page 5, section 3.3) when cultured with polystyrene (see page 6, Figure 5). As such, Kim et al anticipates the instantly claimed invention.
Citation of Relevant Art
Zhang et al (Biotechnology Advances, 60:107991, pages 1-18, May 30 2022). Zhang et al is cited as a review of the state of the art as it relates to biodegradation of polyethylene and polystyrene.
Conclusion
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/Patricia Duffy/Primary Examiner, Art Unit 1645