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 .
Priority
This application is a 371 of PCT/EP2021/085368 (3/14/2024) which claims priority to EP20217178.1 (12/24/2020) as reflected in the filing receipt issued on 11/21/2023.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 6/23/2023 and 11/20/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84(u)(1) states “View numbers must be preceded by the abbreviation “FIG.”.
In the current case, the view numbers for Figures 1 and 2 are preceded by the word “Figure” instead of the abbreviation “FIG.”. View numbers should be updated to recite the abbreviation “FIG.”. Any changes to the drawings should also be reflected in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 6-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koch et al., US 6,255,451 B1 (cited in IDS).
Regarding claim 1, Koch teaches a method of degrading biodegradable polymers using enzymes (Koch “Abstract”). Koch teaches that the biodegradable polymer may be a polyester urethane (polyurethane) (Koch col. 2 lines 29-34). Koch teaches subjecting the polyurethane to an aqueous solution which contains one or more lipases or cutinases (Koch col. 2 lines 17-24). Koch teaches that the lipolytic enzymes of the invention may be used in combination (Koch col. 5 lines 45-58). Lipases are a type of esterase. Thus, Koch teaches a method of degrading PU by subjecting the PU to a cocktail comprising an esterase (lipase) and a cutinase.
Regarding claim 6, Koch teaches that the enzymatic degradation is preferably carried out at a temperature in the range of 30 to 50° C (Koch col. 7 lines 5-9).
Regarding claim 7, Koch teaches that the enzyme solution in the method is preferably at a pH between 6 and 8 (Koch col. 7 lines 1-5).
Regarding claim 8, Koch teaches that the PU is subjected to the enzymes for 5 days (Koch col. 11 lines 45-46).
Regarding claim 9, Koch teaches that biologically and enzymatically degradable polymers, BAEDPs, including PU, are present in packaging, including blister packs or food packaging (Koch col. 7 lines 46-67, col. 8 lines 1-6 and lines 36-46). Koch teaches that the BAEDP material is used for adhesive bonding or coating of cardboard or paper with other plastics, lacquers or metallic materials (Koch col. 7 lines 69-67). Koch teaches that the plastics and lacquers include polyurethanes and polyethylene (Koch col. 7 lines 65-67). Thus, Koch teaches a multilayer structure, wherein a polymeric layer (plastics including polyethylene or polyurethane) is coated with or adhesively bonded to a material with an additional polymeric layer (BAEDPs, which include polyurethane). For example, Koch teaches a material wherein a biodegradable polyester (e.g., polyester urethane) is used for adhesively bonding polyethylene to paper, therefore having two polymeric layers (Koch col. 12 lines 60-65 Example 8). Koch teaches that these materials are treated with the enzymatic degradation method which includes cutinase and lipase treatment (Koch col. 7 lines 29-30).
Regarding claim 10, Koch teaches that the BAEDPs such as PU are used as coatings and adhesives (Koch col. 7 lines 59-67).
Regarding claim 11, Koch teaches that the enzymatically degradable polymers, including PU, may be used as coatings (i.e., a layer of coating on top of another material in a multilayer structure), and that an aim of the method is the selective removal (or selective delamination) of coatings, claddings, coverings or lacquers made of BAEDPs by means of enzymes (Koch col. 8 lines 27-29).
Regarding claim 12, Koch teaches a multilayered structure wherein a base layer (e.g. cardboard, paper) is coated with a polymer layer (which may be PU). Koch teaches that the aim of the method is decomposing the biodegradable polymers (such as PU) enzymatically and thus of removing the other plastics, lacquers or metals, in order to recycle them (Koch col. 7 lines 59-67). Koch teaches that the PU material may be used in packaging, such as blister packs or packaging materials for food or active ingredients (Koch col. 8 lines 1-6, lines 36-40; lines 54-55). Therefore, Koch teaches a multilayered packaging structure with a base layer (e.g. cardboard, paper) that can be recycled, and a PU-based layer (i.e., polyurethane coating). Koch teaches that the method may be used to recycle the base layer after enzymatically decomposing the biodegradable polymer coating, or subjecting the base layer to a recycling stream.
Regarding claim 13, Koch teaches that the polymeric materials may be in comminuted form, meaning that the materials have been reduced to particles (Koch col. 7 lines 15-24).
Claims 1-2, 4, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boisart et al., US 2016/0280881 A1.
Regarding claim 1, Boisart teaches a method of degrading plastics, including polyurethane (PU) (p. 1 para. 1, p. 2 para. 15). Boisart teaches that the method comprises exposing a plastic to at least one enzyme for modifying a polymer of said plastic (p. 1 para. 9). Boisart teaches that the enzymes include a cutinase or an esterase (p. 2 para. 13). Thus, a skilled artisan could at once envisage a method wherein both a cutinase and an esterase are used to treat a PU plastic product, as Boisart teaches that at least one (i.e. two enzymes could be used) of these enzymes, selected from a finite, delineated group of hydrolase enzymes, are used in the method of treating plastic.
Regarding claim 2, Boisart teaches that the enzyme may be a carboxylesterase (p. 2 para. 13).
Regarding claim 4, the instant specification states that the enzymes may be used as crude extracts, for example, as crude extracts from a fungal or microbial source (instant specification p. 9 lines 15-18). Boisart teaches that the polymer plastic is contacted with a microorganism that synthesizes and excretes the enzyme into the culture medium, rather than as a purified enzyme (p. 4 para. 46). The enzymes such as cutinase or esterase secreted into the medium by bacteria are considered to be soluble, crude extracts.
Regarding claim 15, Boisart teaches that the method may be carried out in a bioreactor (Boisart p. 6 para. 64), which is a closed vessel.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Boisart as applied to claims 1-2, 4, and 15 above, in view of Magnin et al., Waste Management; 85:141-50.
Regarding claim 3, Boisart teaches that the cutinase is Thc_Cut1 from Thermobifida cellulosilytica (Boisart p. 7 para. 80).
Boisart does not teach that the esterase is E3769 or Est119.
Regarding claim 3, Magnin teaches PU degradation using enzymes (Magnin Abstract). Magnin teaches that enzymatic depolymerization of synthetic polymers is an appealing approach to reduce a large part of the environmental pollution from these materials and that PU accounts for a significant amount of plastic consumption (Magnin p. 141 para. 1-3). Magnin teaches that esterases are established for enzymatic degradation of PU (Magnin p. 142 para. 1). Magnin teaches the esterase E3769 has PU degrading activity (Magnin p. 144 Section 3.1).
It would have been obvious to a skilled artisan, before the effective filing date, to use E3769 as the esterase in the method of Boisart. Magnin teaches that E3769 degrades PU. Boisart teaches that esterases are used in the method of degrading mixed plastics, including plastics having PU as a component, and therefore a skilled artisan would have found it obvious to utilize E3769, which is known to degrade PU, in a method of degrading plastics that include PU.
A person of ordinary skill in the art would have been motivated to utilize a E3769 esterase as taught by Magnin in the method of Boisart because esterases have known plastic degradation activity, including degradation of PU. As PU is a commonly used polymer in various plastic products which contribute to environmental pollution, it would be of interest to a skilled artisan to utilize an enzyme that is known to have PU degradation activity in a method of degrading mixed plastics that include PU.
A skilled artisan would have a reasonable expectation of success in utilizing E3769 in a method as taught by Boisart because esterases in general are known to be capable of degrading synthetic polymers and E3769 has specifically been shown to have PU degradation activity. Thus, a skilled artisan could reasonably expect success in incorporating E3769 in a method for degrading a plastic material comprising PU.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Koch et al. as applied to claims 1, 6-8, 11, and 13 above, in view of Maille, WO 2015/173265 A1 (cited in IDS).
Regarding claim 5, Koch teaches degradation of plastics, including polyester urethane, by enzymes (Koch “Abstract”; col. 2 lines 29-35). Koch teaches that the enzymes may include cutinases and esterases (col. 6 lines 4-5). Koch teaches that the ratio in which combinations of enzymes are used is preferably 20:80 to 80:20, or 1:4 to 4:1 (Koch col. 5 lines 50-58).
Koch does not teach that the esterase and cutinase are used with an enzyme loading of 0.05 µg protein per mg polymer.
Maille teaches a method of degrading mixed polyethylene terephthalate (PET) plastics (p. 1 lines 1-9). Maille teaches that the mixed PET plastics are contacted with a depolymerase (Maille p. 3 lines 22-26), which include cutinases and esterases, and that several of these depolymerases may be used in combination (Maille p. 4 lines 1-4).
Regarding claim 5, 0.05 µg protein per mg polymer is 0.005% by weight. Maille teaches that the enzyme added for the depolymerization step is in a range of 0.001% to 5% by weight of plastic, which includes 0.005% by weight (p. 21 lines 1-5). When claimed ranges "overlap or lie inside the ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05(I).
It would have been obvious to a skilled artisan to combine the teachings of these references and utilize the cutinase and esterase at a concentration of 0.05 µg protein per mg polymer in the method of Koch. Both Koch and Maille are directed to degradation of polymer plastic products using enzymes including esterases and cutinases. It would have been obvious to a skilled artisan to utilize a concentration within the range taught by Maille to be effective for degradation of PET and other polymers, in a similar method as taught by Koch. A skilled artisan would have had a reasonable expectation of success in doing so because both references teach the same types of enzymes for the same purpose of polymer degradation, and Maille teaches that the enzymes can be effectively used in a range of concentrations including the claimed 0.05 µg protein per mg polymer, or 0.005% by weight.
Regarding claim 14, Koch teaches the method of claim 13 as discussed above.
Koch does not teach that the particle size is reduced by a mechanical treatment to particles with an average diameter of less than about 5 mm (claim 14).
Regarding claim 14, Maille teaches that the polymer degradation method comprises mechanically grinding or granulating the plastic material to reduce the shape and size of the material prior to enzyme treatment (p. 20 lines 4-8). Maille teaches that the mechanical treatment increases surface contact with the enzyme by reducing the particle size to between 500 µm and 250 µm, or 0.5 mm to 0.25 mm, which is less than 5 mm as recited in instant claim 14 (p. 25 lines 9-15).
It would have been obvious to a skilled artisan to use the mechanical grinding method of Maille to achieve a particle size of less than 5 mm because Koch teaches using materials with reduced particle size in the method of PU degradation, and it would have been obvious to use the mechanical grinding technique used by Maille in a similar plastic degradation method to achieve the reduced particle size.
A person of ordinary skill in the art would have been motivated to use such a method, because the mechanical grinding results in increased surface contact with the enzyme, which is beneficial for efficient degradation of the PU product. As Maille teaches this mechanical grinding process to prepare polymer materials to be enzymatically degraded, a skilled artisan would have had a reasonable expectation of success in successfully implementing this technique in the method of Koch, which teaches that the polymer product may be in comminuted form.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, and 6-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-15 of copending Application No. 18/259,159 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to enzymatic degradation of polyurethane.
Regarding instant claim 1, claim 1 of ‘159 recites a method of degrading polyurethane (PU) comprising the step of subjecting the PU to an enzyme cocktail comprising at least one lipase and at least one cutinase. A lipase is a type of esterase, and therefore the subject matter of ‘159 claim 1 anticipates an enzyme cocktail comprising an esterase and a cutinase as instantly claimed.
Regarding instant claims 4 and 6-15, all the limitations of these dependent claims are recited in claims 4 and 6-15 of ‘159.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, and 6-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/250,066 in view of Koch et al., US 6,255,451 B1.
Regarding instant claim 1, claim 1 of ‘066 recites a method of degrading non-biodegradable polyurethane (PU) in packaging material comprising the step of subjecting the packaging material comprising PU deprived of urea linkages to at least one cutinase.
The claims of ‘066 do not recite subjecting the PU to an esterase. However, this feature is taught by Koch.
Regarding instant claim 1, Koch teaches a method of degrading biodegradable polymers using enzymes (Koch “Abstract”). Koch teaches that the biodegradable polymer may be a polyester urethane (polyurethane) (Koch col. 2 lines 29-34). Koch teaches subjecting the polyurethane to an aqueous solution which contains one or more lipases or cutinases (Koch col. 2 lines 17-24). Lipases are a type of esterase. Thus, Koch teaches a method of degrading PU by subjecting the PU to a cocktail comprising an esterase and a cutinase.
It would have been obvious to a skilled artisan to combine the teachings of Koch with the invention of ‘066, treating PU with both a cutinase and an additional esterase. Koch teaches the use of both of these types of enzymes to degrade polyurethane products. A skilled artisan could recognize that the invention of ‘066 could be modified to include an additional enzyme, and would have been motivated to do so in order to improve PU degradation efficiency. There would have been a reasonable expectation of success in utilizing an additional esterase given the teachings of Koch that both cutinases and other esterases can be utilized to degrade PU. Therefore, instant claim 1 is an obvious variation of copending ‘066 in view of Koch.
Regarding claims 4 and 6-15, the features of these dependent claims are recited in claims 1-13 of ‘066.
This is a provisional nonstatutory double patenting rejection.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/250,066 in view of Boisart et al., US 2016/0280881 A1.
The teachings of ‘066 regarding instant claim 1 are set forth above.
The claims of ‘066 do not recite do not recite subjecting the PU to an esterase, or that the esterase is a carboxylesterase as set forth in instant claim 2. However, these features are taught by Boisart.
Regarding instant claims 1 and 2, Boisart teaches a method of degrading plastics, including polyurethane (PU) (p. 1 para. 1, p. 2 para. 15). Boisart teaches that the method comprises exposing a plastic to at least one enzyme for modifying a polymer of said plastic (p. 1 para. 9). Boisart teaches that the enzymes include a cutinase or an esterase (p. 2 para. 13). Boisart teaches that the enzyme may be a carboxylesterase (p. 2 para. 13).
It would have been obvious to a skilled artisan to combine the teachings of Boisart with the invention of ‘066, using a carboxylesterase in the method of PU degradation. Boisart teaches that multiple enzymes are used for degradation of polymers such as PU, including cutinases, esterases, and specifically carboxylesterases. Therefore, a skilled artisan would have found it obvious to use an esterase in addition to a cutinase, and specifically to use that a carboxylesterase in the method of ‘066 in order to improve degradation of PU.
This is a provisional nonstatutory double patenting rejection.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/250,066 in view of Boisart et al., US 2016/0280881 A1 and Magnin et al., Waste Management; 85:141-50.
The teachings of ‘066 and Boisart regarding instant claim 1 are set forth above.
Regarding instant claim 3, claim 1 of ‘066 recites that the cutinase is BC_Cut-13 or Thc_Cut1.
‘066 does not recite an esterase selected from E3769 or Est119. However, this feature is taught by Magnin.
Regarding instant claim 3, Magnin teaches PU degradation using enzymes (Magnin Abstract). Magnin teaches that enzymatic depolymerization of synthetic polymers is an appealing approach to reduce a large part of the environmental pollution from these materials and that PU accounts for a significant amount of plastic consumption (Magnin p. 141 para. 1-3). Magnin teaches that esterases are established for enzymatic degradation of PU (Magnin p. 142 para. 1). Magnin teaches the esterase E3769 has PU degrading activity (Magnin p. 144 Section 3.1).
It would have been obvious to a skilled artisan, before the effective filing date, to use E3769 as the esterase in the method of copending ‘066 and Boisart. Magnin teaches that E3769 degrades PU. Boisart teaches that esterases are used in the method of degrading mixed plastics, including plastics having PU as a component, and therefore a skilled artisan would have found it obvious to utilize E3769, which is known to degrade PU, in a method of degrading plastics that include PU. A person of ordinary skill in the art would have been motivated to utilize a E3769 esterase as taught by Magnin, with a reasonable expectation of success, because esterases have known plastic degradation activity, including degradation of PU and E3769 has specifically been shown to have PU degradation activity. As PU is a commonly used polymer in various plastic products which contribute to environmental pollution, it would be of interest to a skilled artisan to utilize an enzyme that is known to have PU degradation activity in a method of degrading mixed plastics that include PU.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-15 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653