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
Amended Claims 1-15 (dated 08/27/2024) are pending in this application and are now under consideration for examination.
Priority
Acknowledgment is also made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a CON of 17/900,590 262 filed on 08/31/2022 now US 12,071,645, which is a CON of 17/240,262 filed on 04/26/2021 now US 11,466,299, which is a CON of 16/598,317 filed on 10/10/2019 now US 11,021,722, which is a CON of 15/568,945 filed on 10/24/2017 now US 10,472,655, which is a 371 of PCT/EP2016/058987 filed on 04/22/2016 and claims the priority date of UK Application 1507207.7 filed on 04/24/2015.
Information disclosure statement
The information disclosure statement (IDS) submitted on 07/15/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered and initialed by the examiner.
Double Patenting rejection
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-15 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over: (i) claims 1-25 of US Patent 10,472,655 B2, in IDS; (ii) claims 1-19 of US Patent 11,021,722 B2; (iii) claims 1-7 of US Patent 11,466,299 B2; and (iv) claims 1-20 of US Patent 12,071,645 B2 in view of Sato et al, (US 9,902,979 B2). An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim, because the examined claim is either anticipated by, or would have been obvious over reference claim. 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). Although the conflicting claims are not identical, they are not patentably distinct from each other.
Claims 1-15 of the instant application as interpreted are directed to a reaction product comprising (-)-Ambrox obtained by a method comprising enzymatically converting a mixture of isomers comprising (3E,7E)-homofarnesol (EEH) to (-)- Ambrox or a mixture comprising (-)-Ambrox, wherein the enzymatic conversion is carried out using a squalene hopene cyclase/homofarnesol Ambrox cyclase (SHC/HAC) enzyme comprising an amino acid sequence with at least 30% identity to SEQ ID NO: 1, wherein the mixture of isomers comprising EEH is selected from [(3E,7E) and [(3Z,7E)] and/or [(3Z,7E), (3E,7E) and (3E,7Z)], also designated as [EE:EZ] and [EE:EZ:ZE] respectively, wherein (-)-Ambrox is produced in admixture with at least one or more of the by-products (II) or (IV) and (III), … and wherein the reaction product comprising said (-)-Ambrox is isolated.
(i) Claims 1-25 of US Patent 10,472,655 B2 are directed to “a process for preparing (-)-Ambrox … is enzymatically converted by SHC/HAC enzyme comprising the amino acid sequences of SEQ ID NO: 21”; said reference polypeptide of SEQ ID NO: 21 of said reference patent has 99.6% sequence identity to SEQ ID NO: 1 of the instant invention, when there is specifically recited embodiment that encompasses the claimed genus of polypeptides of the instant application, i.e., …having at least 30% sequence identity to SEQ ID NO: 1 and that would mainly anticipate and/or render obvious claims 1-15 of the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other. 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).
(ii) Claims 1-19 of US Patent 11,021,722 B2 are directed to “a process for preparing (-)-Ambrox … is enzymatically converted by SHC/HAC enzyme comprising the amino acid sequences of SEQ ID NO: 1 … SEQ ID NO: 4”; said reference polypeptide of SEQ ID NO: 1 of said reference patent has 100% sequence identity to SEQ ID NO: 1 of the instant invention, when there is specifically recited embodiment that encompasses the claimed genus of polypeptides of the instant application, i.e., …having at least 30% sequence identity to SEQ ID NO: 1 and that would mainly anticipate and/or render obvious claims 1-15 of the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other. 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).
(iii) Claims 1-7 of US Patent 11,466,299 B2 are directed to a reaction product comprising (-)-Ambrox obtained by a method comprising… enzymatically converted by any SHC/HAC enzyme including mutants and variants, said SHC/HAC enzyme comprises a polypeptide having at least 90% sequence identity to amino acid sequences of SEQ ID NO: 1, … or SEQ ID NO: 4 …, said reference polypeptide of SEQ ID NO: 1 of said reference patent has 100% sequence identity to SEQ ID NO: 1 of the instant invention, when there is specifically recited embodiment that encompasses the claimed genus of polypeptides of the instant application, i.e., …having at least 30% sequence identity to SEQ ID NO: 1 and that would mainly anticipate and/or render obvious claims 1-15 of the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other. 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).
(iv) Claims 1-20 of US Patent 12,071,645 B2 are directed to a process for preparing (−)-Ambrox or a mixture comprising (−)-Ambrox, wherein a mixture of isomers comprising (3E,7E)-homofarnesol (EEH) is enzymatically converted to (−)-Ambrox or a mixture comprising (−)-Ambrox, wherein the enzymatic conversion is carried out using a squalene hopene cyclase/homofarnesol Ambrox cyclase (SHC/HAC) enzyme having homofarnesol Ambrox cyclase activity and comprising an amino acid sequence that has at least 30% identity to SEQ ID No. 1 under reaction conditions suitable for the production of (−)-Ambrox, and wherein the mixture of isomers comprising EEH is selected from at least one of [(3E,7E) and [(3Z,7E)], [(3E,7E) and (3E,7Z)] or [(3Z,7E), (3E,7E) and (3E,7Z)] also designated as [EE:EZ], [EE:ZE] and [EE:EZ:ZE] respectively, wherein (−)-Ambrox is produced in admixture with at least one or more of the by-products (II) or (IV) and (III) …, said reference polypeptide of SEQ ID NO: 1 of said reference patent has 100% sequence identity to SEQ ID NO: 1 of the instant invention, when there is specifically recited embodiment that encompasses the claimed genus of polypeptides of the instant application, i.e., …having at least 30% sequence identity to SEQ ID NO: 1 and that would mainly anticipate and/or render obvious claims 1-15 of the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other. 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).
Additionally the following reference of analogous prior art, Sato et al, (US 9,902,979 B2) clearly teaches and provides suggestion and motivation for isolation, purification of ambrein, a related compound to ambrox and wherein the degree of purity is measured by gas chromatography (GC), HPLC or NMR analysis (see col. 9, lines 50-59; col. 16, lines 30-35; col. 19 lines 4-14; and entire document of Sato et al.,); said reference Sato et a., provides Teaching, Suggestion and Motivation for wherein purity is measured by gas chromatography (GC), HPLC or NMR analysis of the instant claims/invention.
Examiner takes the position that the process/method claims in said reference patents is a different form/version of expression of a reaction product comprising (-)-Ambrox obtained by a method comprising… enzymatically converted by any SHC/HAC enzyme including mutants and variants, said SHC/HAC enzyme comprises a polypeptide having at least 30% sequence identity to amino acid sequences of SEQ ID NO: 1, of the instant application and furthermore, the instant application and the cited allowed patents US 10,472,655 B2; US 11,021,722 B2; US 11,466,299 B2; and US 12,071,645 B2 claims use open-ended transitional term “comprising” which is inclusive of additional un-recited elements.
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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