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 .
Amendments Received
Amendments to the claims were received and entered on 12/29/2025.
Status of Claims
Claims 26-35 are newly added.
Claims 17 and 19-35 are currently pending and under consideration.
Priority
Acknowledgment is made of applicant’s claim for benefit under 35 U.S.C. 119(e) of Provisional application No. 63/170,562, filed on April 4, 2021. The present application and all claims are being examined with an effective filing date of April 4, 2021. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Withdrawn Objections
In view of Applicant’s amendments, the objection to claim 17 is hereby withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments, rejections of claims 20-21 and 23-25 under 35 USC § 112(b) are hereby withdrawn.
Maintained Rejection(s)
Claim Rejections - 35 USC § 112(a)
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 17 and 19-35 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
It is noted that MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow. Claim 17 recites the use of “lipase” or “cutinase” enzymes in a method of degrading nylon 6. Therefore, the claim has been broadly interpreted as encompassing a genus of methods of degrading nylon 6, comprising treating a composition comprising nylon 6 with a genus of lipase enzymes or a genus of cutinase enzymes for at least 96 hours. Additionally, claim 19 recites wherein the nylon 6 is treated with “lipase and cutinase”, claim 20 recites wherein the nylon 6 is treated with “cutinase”, and claim 22 recites wherein the nylon 6 is treated with “lipase”.
MPEP 2163 I. states that to “satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
MPEP 2163. II.A.3.(a) states that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
According to MPEP 2163.II.A.3.(a).ii), “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
In the instant case, a broad genus of structurally and functionally diverse proteins derived from various organisms is recited to degrade the polyamide nylon 6. The specification, however, does not provide sufficient disclosure to demonstrate that the inventors were in possession of the full scope of the claimed genus of enzymes. The only examples provided with supporting data in the specification involve ”Lipozyme” and “tfCutinase” (see Fig. 2). According to the specification, it appears that the particular Lipozyme used is “Lipozyme CALB”, a lipase B derived from Candida antarctica, while the “tfCutinase” is a cutinase derived from Thermobifida fusca. The data presented in support of the claimed degradation effect (e.g., at least 5% mass loss after at least 96 hours of contact) is limited to these specific enzymes.
The specification does not disclose a representative number of species spanning the full scope of lipases or cutinases. Nor does the specification identify structural features or sequence characteristics that correlate with the claimed nylon-6 degrading activity. Although lipases and cutinases may share general structural features (e.g., α/β hydrolase fold and catalytic triad), such features are widely conserved across diverse enzyme classes and are not shown to correlate with substrate specificity or nylon-6 degradation activity. Moreover, the specification itself further indicates that enzymatic degradation of nylon-6 is not well understood and is difficult relative to other polymers, demonstrating that the art is unpredictable, and does not provide guidance to distinguish enzymes that achieve the claimed ≥5% degradation from those that do not. This deficiency is further underscored by the additional claimed performance ranges (e.g., multiple fold increases and percentage increases for degradation), for which the specification likewise does not provide sufficient support across the full scope of the claimed genus. Additionally, the specification repeatedly describes identifying suitable enzymes through testing and screening, indicating that the inventors had not identified a defined class of enzymes possessing the claimed activity, but rather were engaged in experimental identification of candidates.
It is noted that claims 34 and 35 recites the specific enzymes described in the working examples; however, the claims remain drafted using open-ended language (e.g., ‘comprising’), and therefore still encompass additional uncharacterized lipases and cutinases beyond those specifically disclosed. As such, these claims continue to include the same unsupported genus and do not overcome the written description deficiency discussed above.
Accordingly, the disclosure does not reasonably convey that the inventors were in possession of the full scope of the claimed genus of lipases and cutinases capable of degrading nylon-6 under the claimed conditions.
Response to Arguments for Rejections under 35 USC § 112(a)
In the response filed on 12/29/2025, Applicant argues that the claimed genus is supported because lipases and cutinases share structural similarities, including an α/β hydrolase fold and a conserved Ser–His–Asp/Glu catalytic triad, and that therefore one of ordinary skill in the art could practice the invention across its scope without undue experimentation. Applicant’s arguments have been considered in full and have not been found to be persuasive for the reasons set forth below.
First, applicant’s arguments are directed to whether one of ordinary skill could practice the invention using routine experimentation, which pertains to enablement, rather than whether the inventors had possession of the full claimed genus, as required for written description under 35 U.S.C. § 112(a). Second, while lipases and cutinases may share a common catalytic mechanism, the cited structural features (α/β hydrolase fold and catalytic triad) are widely conserved across numerous hydrolase enzymes and are not predictive of substrate specificity. It is well established in the art that substrate specificity in hydrolases is determined primarily by features such as substrate-binding regions, active-site architecture, and surface interactions, rather than the mere presence of a catalytic triad.
For example:
Bornscheuer, U.T. (Microbial Carboxyl Esterases: Classification, Properties and Application in Biocatalysis, FEMS Microbiology Reviews, Volume 26, Issue 1, March 2002, Pages 73–81, (2002), cited in PTO-892) — describes diversity of substrate specificity among α/β hydrolases.
Fortuna et al. (Criteria for Engineering Cutinases: Bioinformatics Analysis of Catalophores. Catalysts, 11(7), 784. (2021), cited in PTO-892) — describes that α/β hydrolases are a broad superfamily, show wide substrate specificity diversity, and variability across enzymes sharing the same fold.
Thus, the presence of a catalytic triad does not establish that all lipases or cutinases would exhibit the claimed nylon-6 degrading activity. Third, the specification itself does not demonstrate that the claimed activity is shared across the genus. Rather, it provides limited examples and repeatedly describes identifying suitable enzymes through screening, indicating that not all enzymes within the recited classes possess the claimed functionality.
Accordingly, the specification does not provide a sufficient written description of the full scope of the claimed genus, and the rejection under 35 U.S.C. § 112(a) is maintained.
Conclusion
No claim is in condition for allowance.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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/NAGHMEH NINA MOAZZAMI/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652