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 .
Claims 1-30 are pending in this application, and are under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of 35 U.S.C. 112 (pre-AIA ). See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/823,136, filed March 25, 2019, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112 (pre-AIA ), first paragraph for one or more claims of this application. The application fails to provide support for the claims under examination, since there is no disclosure therein of use of a yeast origin of replication in a vector. There earliest disclosure of the yeast origin of replication (a 2µ origin) is found in U.S. Provisional Patent Application No. 62/871,879, filed July 9, 2019. Therefore the effective filing dated of the claimed invention is deemed to be July 9, 2019.
Information Disclosure Statement
The Information Disclosure Statements filed May 3, 2022 (2) and May 23, 2023 have been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign mentioned in the description: 404. 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. 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.
Specification
The use of the terms NEXTSEQ® at paragraph [00200] and AMPURE® at paragraph [00208], which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1 and 27 are objected to because of the following informalities:
At claim 1, line 21, “configured to render inactive” should be changed to “that renders inactive.”
At claim 27, line 22, “configured to render inactive” should be changed to “that renders inactive.”
Appropriate correction is required.
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 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.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,815,467.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘467 patent claims a composition of matter for performing RNA-directed nuclease editing in yeast that comprises two or more editing cassettes that are the same editing cassettes of the instant application, and the instant application claims a method for performing RNA-directed nuclease editing in yeast. While the ‘467 patent does not claim the first and second linear backbones or a tRNA linker, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that the editing cassettes can be inserted into the vector backbones and used for the transformation of the yeast cells for subsequent RNA-directed nuclease editing with a predictable and reasonable expectation of success. Therefore, the instant claims are not patentably distinct from the issued claims.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,034,945.
Although the claims at issue are not identical, they are not patentably distinct from each other because the both the ‘945 patent and the instant application claim a method for performing simultaneous multiplex RNA-directed nuclease editing in yeast cells using a composition of matter that comprises two or more editing cassettes that are the same as those claimed by the instant application. While the ‘945 patent does not claim use of the first and second linear backbones or a tRNA linker, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that the editing cassettes can be inserted into the vector backbones and used for the transformation of the yeast cells for subsequent RNA-directed nuclease editing with a predictable and reasonable expectation of success.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,149,260.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘260 patent claims a library of linear vector backbones and editing cassettes and the instant application claims a method for performing simultaneous multiplex RNA-directed nuclease editing in yeast cells using a composition of matter that comprises two or more editing cassettes that are the same as those claimed by the instant application. While the ‘260 patent does not claim the first and second linear backbones or tRNA linkers, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that the editing cassettes can be inserted into the vector backbones and used for the transformation of the yeast cells for subsequent RNA-directed nuclease editing with a predictable and reasonable expectation of success.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-30 of U.S. Patent No. 11,279,919.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘919 patent and the instant application claim a method for performing simultaneous multiplex RNA-directed nuclease editing in yeast cells using a composition of matter that comprises two or more editing cassettes that are the same as those claimed by the instant application. While the ‘919 patent does not claim the instant libraries, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that the ‘919 patent’s method of transformation of the yeast cells can employ the editing cassettes and tRNA linkers with a predictable and reasonable expectation of success.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,306,299.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘299 patent claims a library of linear vector backbones and editing cassettes and the instant application claims a method for performing simultaneous multiplex RNA-directed nuclease editing in yeast cells using a composition of matter that comprises two or more editing cassettes that are the same as those claimed by the instant application. While the ‘299 patent does not claim the first and second linear backbones or tRNA linkers, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that the editing cassettes can be inserted into the vector backbones and used for the transformation of the yeast cells for subsequent RNA-directed nuclease editing with a predictable and reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Young et al. (PCT Patent Application Publication No. WO 2017/216392, published December 21, 2017, and cited in the Information Disclosure Statement filed May 3, 2022) is deemed to be the closest prior art to the claimed invention. While Young discloses a composition comprising a promoter, transcription start sequence, a donor sequence having an edit, a self-cleaving ribozyme, a guide sequence and a terminator sequence, Young does not disclose or suggest the use of Pol II sequences, including edits to inactivate PAM sequences, the use of a tRNA linker to connect the two editing cassettes or the orientation of each of the claimed components used in the composition, which provides for RNA-nuclease directed editing in yeast.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NEIL HAMMELL can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636