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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/22/2026 has been entered.
Application status
In response to the previous Office action, a Final rejection (mailed on 03/19/2026), Applicants filed a response and amendment received on 06/22/2026. Said amendment canceled Claims 7, 9-10 and 15-16, and amended Claims 1 and 8. Thus, Claims 1-6, 8 and 11-14 are at issue and present for examination.
Claim Objections - WITHDRAWN
The previous objection of Claim 1 for the recitation of “Pseudonumas” because it’s misspelled is withdrawn by virtue of Applicants’ amendment.
Claim Rejections - 35 USC § 101 - MAINTAINED
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 1-6, 8 and 11-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without significantly more.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
(1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
(Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
(Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
(2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG))
Question 1: Yes; the claims are directed to a composition of matter and a process of using said composition.
Question 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a composition comprising a naturally occurring bacterial strain Pseudomonas migulae strain JNU 01, a basal salt medium comprising polystyrene powder, and a plastic wherein the polystyrene powder is a sole carbon source.
Question 2A – Prong 2: No, the claims do not recite anything additional which integrate the naturally occurring product/protein into a practical application. It is noted that Pseudomonas migulae strain JNU 01 is isolated from soil containing plastic. A basal salt medium comprising polystyrene powder does not alter the naturally occurring Pseudomonas migulae strain JNU 01 in any way, or make any “markedly different changes” to the naturally occurring bacteria. There is nothing in the claims which differentiates this naturally occurring Pseudomonas migulae strain in terms of structure and/or function other than a plastic which also occurs naturally in soil (see page 6, lines 7-11 of the instant specification), and a basal salt medium comprising polystyrene powder, which is commonly used as a carbon-free medium to test for, isolate, and study polystyrene-degrading bacteria and fungi as evidenced by Kim et al. (Biodegradation of polystyrene by bacteria from the soil in common environments , Journal of Hazardous Materials 416 (2021) 126239).
The Examiner also notes that the instant specification discloses lack of ‘hand of man’, i.e., a modification of a naturally occurring bacterial strain by recombinant techniques introducing a heterologous polynucleotide into said bacterial strain. Thus, there is ultimately nothing in the claims which amounts to significantly more or significantly different from that found in nature.
Question 2B: As noted in answering that of 2A – Prong 2 above, there is nothing in the claims which amounts to significantly more in terms of structure and/or function and the claims read on naturally occurring Pseudomonas migulae and the methods of using said Pseudomonas migulae with a plastic and a basal salt medium which is also naturally occurs in nature, or commonly used with said bacteria as explained above. Thus, the claims are drawn to a judicial exception, namely, a naturally occurring product/process.
Applicants’ Arguments:
As amended, independent claims 1 and 8 (from which claims 2-5 and 11-14 ultimately depend) now call for an isolated Pseudomonas migulae strain in combination with a basal salt medium comprising polystyrene powder. The combination of these components in amended claims 1 and 8 is not found in nature and exhibits markedly different characteristics.
Pseudomonas migulae bacteria in nature exist in soil that may contain plastic debris, but there is no evidence that the bacteria in that natural environment are actively metabolizing polystyrene as a sole carbon source, creating porous degradation structures in polystyrene film, or chemically modifying polystyrene to introduce hydroxyl groups, as demonstrated by the specification. See Specification, [0099]-[0101]; FIGS. 4A and 4B. In contrast, the claimed composition, i.e., an isolated, characterized, deposited strain in a basal salt medium comprising polystyrene as the sole carbon source, combined with a plastic, represents a fundamentally different functional relationship from the incidental co-existence of bacteria and plastic waste in soil. No such combination of an isolated strain, a synthetic basal salt medium, and a plastic substrate exists in nature, and it is entirely a product of human engineering.
Notably, the specification discloses that the basal salt medium (BSM) used in the present invention comprises a defined, synthetic mineral composition, for example, 12.8 g Na2HPO4-7H20, 3 g KH2PO4, 0.5 g NaCl, 1 g NH4Cl, 2 mM MgSO4, and 0.1 mM CaCl2 per liter, with polystyrene powder as the sole carbon source. See Specification, [0063]-[0070]. This is a precisely formulated, laboratory-prepared medium that serves a specific functional purpose: to provide the mineral nutrients necessary for bacterial growth while constraining the available carbon source exclusively to polystyrene polymer. Because the claimed composition requires this non-natural component, the composition as a whole cannot be characterized as a product of nature. Under MPEP § 2106.04(c), when a claim recites a combination that includes multiple components, the combination as a whole should be analyzed for markedly different characteristics, rather than each component separately.
Here, the claimed composition, an isolated strain in a synthetic basal salt medium with polystyrene as the sole carbon source, combined with a plastic substrate, is precisely such a combination. The BSM provides a defined nutritional environment in which the strain actively metabolizes polystyrene, thereby enabling the practical application of plastic degradation. Without the BSM constraining the sole carbon source to polystyrene, the demonstrated biodegradation activity would not occur. These distinguishing characteristics rise to the level of a marked difference, such that the claimed composition is not a "product of nature" exception.
Because the claimed composition in each of amended claims 1 and 8 includes a combination of components that is not found in nature, the composition as a whole is not a product of nature and does not recite a judicial exception under Step 2A or Step 2B of the 2019 PEG.
Given the foregoing, Claims 1-6, 8, and 11-14 are directed to patentable subject matter. Accordingly, Applicant respectfully requests withdrawal of the rejection.
Examiner’s Explanations:
Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons. Contrary to Applicants’ argument, the addition of a basal salt medium which is identical to the basal salt medium taught in the evidentiary reference of Kim et al. (see page 2 under “2.1. Chemicals and media”) does not produce a “markedly different changes” to the naturally occurring bacterial strain. It is like arguing ‘naturally occurring human epithelial cells’ are patentable and does not have any 35 USC 101 issues because it is immersed in a chemically defined, carbon-free basal media that is known in the art. In other words, the presence of the basal salt medium does not produce “markedly different changes” to the naturally occurring bacterial strain.
For the reasons provided herein and in the previous office action, the instant rejection is maintained.
Conclusion
Claims 1-6, 8 and 11-14 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
The instant Office action is non-final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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