DETAILED ACTION
Notice of Pre-AIA or AIA Status
Claim(s) 1, 21-25 is/are pending.
Claim(s) 1, 21, 23-24 is/are rejected.
Claim(s) 22, 25 is/are withdrawn from consideration.
Claim(s) 2-20 is/are cancelled by Applicant.
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 .
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 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.
Response to Election/Restrictions
Applicant’s election without traverse of species (a)(ii) and (b)(ii) and (c)(i) in the reply filed on 01/31/2025 is acknowledged.
The Election of Species Requirement in the previous Office Action 12/03/2025 with respect to species (d) has been withdrawn in view of the Claim Amendments filed 01/31/2025.
Claim(s) 22, 25 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/31/2025.
Claim Objections
Claim(s) is objected to because of the following informalities:
In claim 1, the newly added language is nearly illegible because of excessive pixelation.
MPEP 608.01 requires that the specification (including the abstract and claims), and any amendments for applications must have text presented in a form having sufficient clarity and contrast between the paper and the writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition; and only a single column of text. See 37 CFR 1.52(a)
Applicant should carefully review any new submissions to ensure full compliance with legibility requirements (e.g., that ALL text is in black, and not gray or otherwise highlighted; etc.)
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.
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.
Claim(s) 23-24 is/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.
Regarding claims 23-24, the disclosure as originally filed only provides support for: (i) “poly(lactic acid) containing less than 2 wt. % enzymes are depolymerized in days with up to 98% polymer-to-small molecule conversion” only with respect to “days” (i.e., more than 1 day); and (ii) "98% conversion within 24 hours" and ">95% PCL-small molecule conversion in one day" only with respect to a polycaprolactone (PCL)-RHP-BC-lipase composition. However, the specification does not provide support for the recited “~98% conversion within 24 hours” for: (1) other polymers (besides PCL) and other enzymes (besides BC-lipase) (claim 1); or (2) specifically a polylactic acid (PLA) / proteinase K system (claim 21).
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.
Claim(s) 1, 21, 23-24 is/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 pre-AIA the applicant regards as the invention.
Claim 1 is vague and indefinite because it is unclear what degree of depolymerization is required to qualify as “substantially complete depolymerization” (as compared to simply “complete depolymerization”).
Claim 1 is vague and indefinite because it is unclear what degree of “microplastics formation” is required to qualify as “without substantial microplastics formation” (e.g., less than 50%? less than 20%? less than 10%? etc.).
Claim 1 is vague and indefinite because it is unclear what degree of “polymer-to-small molecule conversion” is required to qualify as “near-complete polymer-to-small molecule conversion” (as compared to simply “complete polymer-to-small molecule conversion”).
Claim 1 is vague and indefinite because it is unclear what the percentage refers to and what the percentage is based on. For example, does the phrase “0.01 to 1.5 wt %” refer to:
• the amount of the nanoscopic dispersion based on the total amount of plastic, nanoscopic dispersion, and enzyme protectant?
• the amount of the enzyme based on the total amount of plastic, nanoscopic dispersion, and enzyme protectant?
• the amount of the enzyme relative to the amount of enzyme protectant?
• the amount of enzyme based on the amount of nanoscopic dispersion?
Claims 21, 23-24 are dependent on one or more of the above claims and therefore incorporate the above-described indefinite subject matter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1, 21 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over:
• claims 1-19 of U.S. Patent No. 12,281,208 (XU ET AL).
Although the claims at issue are not identical, they are not patentably distinct from each other because the U.S. Patent claims a method of programmable degradation and microplastic elimination which utilizes a bioactive plastic composition comprising: (i) a polymer; and (ii) a nanoscopic dispersion of hydrolyzing enzymes and random heteropolymers (RHPs) (corresponding to the recited “enzyme protectant”), wherein the bioactive plastic composition can be polylactic acid (PLA) and proteinase K, wherein the enzyme content can be 0.001-1 wt%, and wherein the degradation mechanism can be selective chain end scission.
Claim Rejections - 35 USC § 103 (AIA )
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• DALIBEY ET AL (US 2020/0199354),
in view of RANDOM HETEROPOLYMERS PRESERVE PROTEIN FUNCTION IN FOREIGN ENVIRONMENTS (hereinafter “RANDOM HETEROPOLYMERS”),
and in view of STRUCTURAL EFFECTS OF TERMINAL GROUPS ON NONENZYMATIC AND ENZYMATIC DEGRADATIONS OF END-CAPPED POLY(L-LACTIDE) (hereinafter “STRUCTURAL EFFECTS OF TERMINAL GROUPS”)
DALIBEY ET AL ‘354 discloses a method of controllably degrading a plastic article, wherein the method comprises:
• providing a plastic material (e.g., semi-crystalline polyesters such as polylactic acid (PLA), etc.);
• incorporating a biological entity (e.g., proteinase K, which is an enzyme with a polylactic acid (PLA)-degrading activity) (corresponding to the recited “enzyme is a hydrolase” and “enzyme comprises an active site matched with the polyester backbone”) in the plastic material (e.g., PLA, etc.), wherein:
• the biological entities comprising enzymes which can be encapsulated (e.g., in nanocapsules or cage molecules);
• the biological entities (e.g., enzymes) are preferably present in amounts of 0.01-10 wt% based on the total weight of the plastic article;
• subjecting the degradable plastic article containing biological entities (e.g., enzymes) to biodegradation conditions (e.g., in water, etc.) and/or composting conditions to reduce a substantial amount (e.g., 90 wt%, etc.) of the plastic article to oligomers and/or monomers, water, carbon dioxide or methane, and biomass (corresponding to the recited “incubating the plastic under conditions to effect substantially complete depolymerization of the polymer without substantial microplastics formation with partial polymer degradation”).
(entire document, e.g., paragraph 0007-0013, 0075-0081, 0095-0101, 0173-0174, 0177-0179, 0356-0370, etc.) However, the reference does not specifically discuss the use of random heteropolymer (RHPs) as an enzyme protectant.
RANDOM HETEROPOLYMERS discloses that it is well known in the art to utilize random heteropolymers (RHPs) to encapsulate enzymes in order to form a nanoscopic polymeric shell which: (1) stabilizes and protects the enzyme (e.g., structurally, etc.) from foreign environments (e.g., polymer processing conditions, etc.); and/or (2) adjusts the dispersion and/or solubility characteristics of the enzyme, thereby producing RHP/enzyme complexes with nanoparticle size. (entire document).
STRUCTURAL EFFECTS OF TERMINAL GROUPS provides evidence that it is well known in the art that proteinase K is a known PLLA-degrading endo-type and exo-type enzyme which, as an exo-type enzyme, at least partially functions by reacting with the terminal chain end of PLLA molecules (corresponding to the recited “degraded primarily by chain-end mediated processive depolymerization”) (i.e., the enzymatic degradation reaction primarily occurs at the polymer surface because chain end groups are segregated on the surface). (page 1071, etc.)
Regarding claims 1, 21, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize known RHPs as disclosed in RANDOM HETEROPOLYMERS (corresponding to the recited “enzyme protectant”) to form nano-sized encapsulations and/or cages for PLA-degrading enzymes incorporated into the degradable plastic articles of DALIBEY ET AL ‘354 in order to protect said enzymes from hostile polymer processing conditions (e.g., masterbatch formation by dispersion or dissolution in solvents or melt-blending; polymer compounding conditions (e.g., in an melt-extruder, etc.); etc.) and thereby ensure that the enzymes retain a high level of degradation activity even after incorporation into a variety of plastic articles manufactured by various processing methods.
Further regarding claims 1, since STRUCTURAL EFFECTS OF TERMINAL GROUPS provides evidence that proteinase K is capable of degrading PLA-type resins by reacting with the terminal chain ends of the polymer, the Examiner has reason to believe that a PLA-based plastic articles containing encapsulated proteinase K in accordance with DALIBEY ET AL ‘354, wherein the encapsulated proteinase K is dispersed in the plastic in the form of protected nano-scale RHP-encapsulated particles (as suggested by RANDOM HETEROPOLYMERS) would exhibit a substantial degree of degradation at the polymer chain ends of the plastic (corresponding to the recited “wherein the active site and enzyme-protectant interactions are configured to provide processive depolymerization of the polymer as the primary degradation pathway” and the recited “degraded primarily by chain-end mediated processive depolymerization”) as recited in claim 1, therefore the Examiner has basis for shifting the burden of proof to applicant as in In re Fitzgerald et al., 205 USPQ 594.
Further regarding claim 1, one of ordinary skill in the art would have: (i) selected the type and amount of enzymatic biological entity incorporated into the degradable plastic articles of DALIBEY ET AL ‘354; and (ii) optionally incorporated effective amounts of additional other known biodegradation and/or depolymerization aids into the degradable plastic articles of DALIBEY ET AL ‘354; in order to obtain degradable with adequate physical properties (e.g., tensile strength, flexibility, heat resistance, etc.) and sufficient durability for known end-use applications, combined with, after usage, the desired high degree of biodegradation and/or composting characteristics for specific disposal conditions (corresponding to the recited “programmable degradation of a plastic” and the recited “substantially complete depolymerization of the polymer without substantial microplastics formation with partial polymer degradation: and the recited “programmable latency and material integrity, with near-complete polymer-to-small molecule conversion”).
Claim(s) 1, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• EMBEDDED ENZYME NANOCLUSTERS DEPOLYMERIZE POLYESTERS VIA CHAIN_END MEDIATD PROCESSIVE DEGRADATION (hereinafter “EMBEDDED ENZYME NANOCLUSTERS”).
EMBEDDED ENZYME NANOCLUSTERS discloses a method of programmable polymer degradation which utilizes a plastic composition comprising: (i) a semi-crystalline polyester (e.g., PLA, etc.); and (ii) a dispersion of enzyme nanoclusters (e.g., comprising proteinase K in amounts of about 0.02 wt% and random heteropolymers (RHPs) (corresponding to the recited “enzyme protectant”)), wherein the bioactive plastic composition can be polylactic acid (PLA) and proteinase K, wherein the plastic composition experiences chain-end mediated processive depolymerization (e.g., in biodegradation and/or composting conditions) and reduces microplastic formation (corresponding to the recited “programmable degradation of a plastic” and the recited “the active site and enzyme-protectant interactions are configured to provide processive depolymerization of the polymer as the primary degradation pathway with expanded substrate selectivity, and incubating the plastic under conditions to effect substantially complete depolymerization of the polymer without substantial microplastics formation with partial polymer degradation”) and the recited “programmable latency and material integrity, with near-complete polymer-to-small molecule conversion”) (entire document)
Regarding claims 1, 21, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize known methods of controllably degrading plastic materials as disclosed in EMBEDDED ENZYME NANOCLUSTERS in order to effectively and selectively degrade plastic composition, while retaining high enzyme activity after exposure to polymer processing conditions.
Further regarding claim 1, one of ordinary skill in the art would have: (i) selected the type and amount of the dispersion of enzyme nanoclusters incorporated into the degradable polyester materials of EMBEDDED ENZYME NANOCLUSTERS; and (ii) optionally incorporated effective amounts of additional other known biodegradation and/or depolymerization aids into the degradable polyester materials of EMBEDDED ENZYME NANOCLUSTERS; in order to obtain degradable with adequate physical properties (e.g., tensile strength, flexibility, heat resistance, etc.) and sufficient durability for known end-use applications, combined with, after usage, the desired high degree of biodegradation and/or composting characteristics for specific disposal conditions (corresponding to the recited “programmable degradation of a plastic” and the recited “substantially complete depolymerization of the polymer without substantial microplastics formation with partial polymer degradation: and the recited “programmable latency and material integrity, with near-complete polymer-to-small molecule conversion”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
DAVE ET AL (US 2008/0086199) and FERREIRA ET AL (US 2014/0302378) disclose plastic articles comprising mixtures of PLA and proteinase K.
GUEMARD ET AL (US 2020/0190279) and GUEMARD ET AL (US 2018/0142097) disclose plastic articles containing nano-encapsulated enzymes.
“Near-complete depolymerization of polyesters with nano-dispersed enzymes” and “Enzymatic Self-Biodegradation of Poly(L-lactic acid) Films by Embedded Heat-Treated and Immobilized Proteinase K” and OKABE ET AL (US 2022/0358727) disclose adjustably degradable resin products containing protected enzymes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vivian Chen (Vivian.chen@uspto.gov) whose telephone number is (571) 272-1506. The examiner can normally be reached on Monday through Thursday from 8:30 AM to 6 PM. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Callie Shosho, can be reached on (571) 272-1123. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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February 21, 2026
/Vivian Chen/
Primary Examiner, Art Unit 1787