Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-16 submitted on 7/23/2024 are pending .
.Applicants’ election without traverse of group I (claims 1-7) directed to non-naturally occurring variant LovD polypeptide having increased thermal stability relative to the wild-type Aspergillus terreus acyltransferase of SEQ ID NO:2, which comprises the amino acid sequence of SEQ ID NO:2 that includes at least one mutation at position selected from Q241, A261, Q295 and Q412, and from 1 to 30 additional mutations, as compared to SEQ ID NO: 2. in their response of 5/8/2026 is acknowledged. Since claims 8-16 comprise non elected subjected are withdrawn.
Claims 1-7 for examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/23/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the IDS statement.
Claim Rejections
Claim Rejections: 35 USC § 112(b)
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 1, 2-7 [ depends on claim 1] 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite in recitation of,.” acyltransferase of SEQ ID NO:2, which comprises the amino acid sequence of SEQ ID NO:2 that includes at least one mutation at position selected from Q241, A261, Q295 and Q412, and from 1 to 30 additional mutations, as compared to SEQ ID NO: 2”, because it is unclear how acyltransferase of SEQ ID NO:2, which comprises the amino acid sequence of SEQ ID NO:2 can have one mutation at position selected from Q241, A261, Q295 and Q412, and from 1 to 30 additional mutations. The acyltransferase of SEQ ID NO:2, which comprises the amino acid sequence of SEQ ID NO:2 comprise exactly the Sequence of SEQ ID NO: 2. The claim makes no sense. Applicants may amend the claims as a variant having percentage identity ( say at least 90% identity to the amino acid sequence of SEQ ID NO:2). Correction is required,
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. See 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
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).
At least Claims 1 of instant application which is directed to non-naturally occurring variant LovD polypeptide having increased thermal stability relative to the wild-type Aspergillus terreus acyltransferase of SEQ ID NO:2, which comprises the amino acid sequence of SEQ ID NO:2 that includes at least one mutation at position selected from Q241, A261, Q295 and Q412, and from 1 to 30 additional mutations are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claims 3 of the US PAT 11926857. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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). Although the conflicting claims are not identical, they are not patentably distinct from each other. Claims herein and claims US PAT 10858680 are both directed to method of making statin compound using Lov D acyltransferase variant of SEQ ID NO: 2,.
At least Claims 1 of instant application which is directed to non-naturally occurring variant LovD polypeptide having increased thermal stability relative to the wild-type Aspergillus terreus acyltransferase of SEQ ID NO:2, which comprises the amino acid sequence of SEQ ID NO:2 that includes at least one mutation at position selected from Q241, A261, Q295 and Q412, and from 1 to 30 additional mutations are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claim 3 of the US PAT11926857. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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). Although the conflicting claims are not identical, they are not patentably distinct from each other.
claim 1 of instant application which is directed to non-naturally occurring variant LovD polypeptide having increased thermal stability relative to the wild-type Aspergillus terreus acyltransferase of SEQ ID NO:2, which comprises the amino acid sequence of SEQ ID NO:2 that includes at least one mutation at position selected from Q241, A261, Q295 and Q412, and from 1 to 30 additional mutations are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claim 3 of the US PAT11926857. claim 3 of the US PAT11926857 is directed to non-naturally occurring variant LovD polypeptide having increased thermal stability relative to the wild-type Aspergillus terreus acyltransferase of SEQ ID NO:2, which comprises 90% identity to amino acid sequence of SEQ ID NO:2 that includes at least one mutation at position selected from A261V ( see claim 3(v).The portion of the specification of the US PAT 11926857 that supports the recited Lov D acyltransferase variant of SEQ ID NO: 2 would anticipate Claims herein.
At least claim 6 of instant application which is directed to non-naturally occurring variant LovD polypeptide having increased thermal stability relative to the wild-type Aspergillus terreus acyltransferase of SEQ ID NO:2, which comprises the amino acid sequence of SEQ ID NO:2 that includes at least one mutation at position selected from Q241, A261, Q295 and Q412, and at least one from 1 to 30 additional mutations selected from A247S are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claim 3 of US PAT12371723 is directed to non-naturally occurring variant LovD polypeptide having increased thermal stability relative to the wild-type Aspergillus terreus acyltransferase of SEQ ID NO:2, which comprises 90% identity to amino acid sequence of SEQ ID NO:2 that includes mutation at position selected from A247S and A261V. The portion of the specification of the US PAT 12371723 that supports the recited Lov D acyltransferase variant of SEQ ID NO: 2 would anticipate Claims herein.
At least claim 6 of instant application which is directed to non-naturally occurring variant LovD polypeptide having increased thermal stability relative to the wild-type Aspergillus terreus acyltransferase of SEQ ID NO:2, which comprises the amino acid sequence of SEQ ID NO:2 that includes at least one mutation at position selected from Q241, A261, Q295 and Q412, and at least one from 1 to 30 additional mutations selected from G275S are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claim 3 of US PAT 11046982. Claim 3 of reference patent is directed to non-naturally occurring variant LovD polypeptide having increased thermal stability relative to the wild-type Aspergillus terreus acyltransferase of SEQ ID NO:2, which comprises 90% identity to amino acid sequence of SEQ ID NO:2 that includes mutation at position selected from G275S and A261V. The portion of the specification of the US PAT 11046982 that supports the recited Lov D acyltransferase variant of SEQ ID NO: 2 would anticipate Claims herein.
Terminal Disclaimers for the above patents would overcome the rejections
Conclusion
Claims 1-7 are rejected .
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMAD Y MEAH whose telephone number is (571)272-1261. The examiner can normally be reached on monday-friday (8-7).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 4089187584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMAD Y MEAH/Examiner, Art Unit 1652
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