DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-19 are pending.
Priority
3. Acknowledgement is made of applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d) to Europe Patent Application No. EP20200815.7, filing date 10/08/2020. The certified copy has been filed in the present application, filed on 04/05/2023.
Information Disclosure Statement
4. The IDS filed on 07/26/2023 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
Drawings
5. The Drawings filed on 04/05/2023 are acknowledged and accepted by the examiner.
Claim Rejections - 35 USC § 101
6. 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.
7. Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to without significantly more. The claim(s) recite(s) a whole broth enzyme composition produced according to the process as defined in claim 1. This judicial exception is not integrated into a practical application because it encompasses a naturally occurring enzyme or enzymes that are not markedly different in structure from its natural counterpart. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a whole broth enzyme composition is sufficiently broad to encompass any enzyme or enzymes that are naturally produced by a cell. Although the claims recite “produced according to the process as defined in claim 1”, this recitation is a “product-by-process” limitation and is not sufficient to transform the enzyme or enzymes into something that is markedly different in structure from its natural counterpart. MPEP 2113.I states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”. Accordingly, claim 17 is not patent eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
8. 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.
9. Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pakula et al. (WO 2011/151513 A1; cited on the IDS filed on 07/26/2023).
10. Claim 17 is drawn to a whole broth enzyme composition produced according to the process as defined in claim 1.
11. With respect to claim 17, Pakula et al. teach a whole broth enzyme produced from a genetically modified filamentous fungal host [see Abstract; p. 2-4]. Although Pakula et al. does not explicitly teach produced by the process as defined in claim 1, this recitation is a “product-by-process” limitation and is not sufficient to transform the enzyme or enzymes into something that is markedly different in structure from its natural counterpart. MPEP 2113.I states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”.
Double Patenting
12. 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.
13. Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12-18 and 20 of copending Application No. 18/036,805. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-9, 12-18, and 20 of the ‘805 application are drawn to methods, filamentous fungus cells, and enzyme compositions comprising a process for production of a technical enzyme composition, comprising the following steps: providing a fermentation medium with a glucose content from 5 to 550 g/L; addition of at least one filamentous fungus cell wherein SEQ ID NO: 1 has been disrupted, wherein the filamentous fungus cell is selected from the species Trichoderma reesei; mixing of the fermentation medium and the at least one filamentous fungus cell for a time period of from 1 minute to 10 days at a temperature of from 20 to 35oC; obtaining a technical enzyme composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-18 of copending Application No. 18/286,060. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-9 and 11-18 of the ‘060 application are drawn to methods, filamentous fungus cells, and enzyme compositions comprising a process for production of a technical enzyme composition, comprising the following steps: providing a fermentation medium with a glucose content from 5 to 550 g/L; addition of at least one filamentous fungus cell wherein SEQ ID NO: 1 has been disrupted; mixing of the fermentation medium and the at least one filamentous fungus cell for a time period of from 1 minute to 10 days at a temperature of from 20 to 35oC; obtaining a technical enzyme composition; wherein the at least one filamentous fungus cell is a Trichoderma reesei cell.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
15. Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13-19, 21, and 24-25 of copending Application No. 18/267,276. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-10, 13-19, 21, and 24-25 of the ‘276 application are drawn to methods, filamentous fungus cells, and enzyme compositions comprising a process for production of for production of a whole broth enzyme composition, comprising the following steps: providing a fermentation medium, originating from hydrolysis of lignocellulosic biomass with a glucose content of from 5 to 450 g/L, a xylose content of from 2 to 300 g/L, a density of from 1 to 2 kg/L and a dry matter content of from 10 to 75% wt; addition of at least one filamentous fungus cell wherein SEQ ID NO: 1 has been disrupted; mixing of the fermentation medium and the at least one filamentous fungus cell for a time period of from 1 minute to 10 days at a temperature of from 20 to 35oC; obtaining a whole broth enzyme composition; wherein the at least one filamentous fungus cell is selected from the species Trichoderma reesei.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
16. Status of the claims:
Claims 1-19 are pending.
Claims 1-19 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 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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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656