Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Application status
Claims 1, 3-7, 9-10 and 24-27 are pending in this application.
Priority
It is acknowledged that the instant application is a CON of 17812400, filed on 07/13/2022, which is a CON of 17/065,340 filed on 10/07/2020 (now abandoned), which is a CON of 16/299,068 filed on 03/11/2019 (now abandoned), which is a CON of 15/472,175 filed on 03/28/2017 (now PAT 10273524), which is a CON of 14/315,676 filed on 06/26/2014 (now PAT 9683257), which is a CON of 13/006,625 filed on 01/14/2011 (now abandoned), which is a CON of PCT/US2009/050566 filed on 07/14/2009, which claims benefit of 61/080,453 filed on 07/14/2008.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/14/2024 and 05/22/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 U.S.C. § 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1, 3-7, 9-10, 24-25 and 27 are rejected under 35 U.S.C. § 102(a) as being anticipated by Arnould et al. and under 35 U.S.C. § 102(e) as being anticipated by Arnould et al. (WO 2008/010093 published 01/24/2008, see IDS)
The instant claims are drawn to a method for cleaving a double-stranded DNA comprising: (a) identifying in said DNA at least one recognition site for a rationally-designed I-CreI- derived meganuclease with altered specificity relative to I-CreI, wherein said recognition site is not cleaved by a naturally-occurring I-CreI, wherein said recognition site has a four base pair central sequence selected from the group consisting of GAGT, ACGC, CCGC and GCGC; (b) providing said rationally-designed meganuclease; and (c) contacting said DNA with said rationally-designed meganuclease; whereby said rationally-designed meganuclease cleaves said DNA.
Arnould et al. teach a method for cleaving a double-stranded DNA comprising: (1) rationally designing I-CreI-derived meganuclease;
(2) identifying in said DNA at least one recognition site for a rationally-designed I-CreI-derived meganuclease with altered specificity relative to I-CreI, wherein said recognition site is not cleaved by a naturally-occurring I-CreI (see page 50, last paragraph continued to page 51; page 11, lines 25-29; and Figure 2), wherein said recognition site has a four base pair central sequence selected from the group consisting of GAGT shown in Table III next to SEQ ID NO: 154; ACGC shown in Table III next to SEQ ID NO: 168, GCGC shown in Table III next to SEQ ID NO: 155;
(3) producing/expressing said I-CreI-derived meganuclease;
(4) providing said rationally-designed meganuclease; and
(5) contacting said DNA with said rationally-designed meganuclease; whereby said rationally-designed meganuclease cleaves said DNA (see Examples 1-12), thereby anticipating claims 1, 9-10, 24-25 and 27. The DNA cleavage taught by Arnould et al. is in vitro genomic DNA from fungi, i.e., yeast, or in vivo, i.e., chromosome (see page 10, lines 16-27), thereby anticipating claims 3-7. Therefore, the reference of Arnould et al. anticipates the Applicants’ claimed methods.
Claims 1, 3-7, 9-10 and 26 are rejected under 35 U.S.C. § 102(b) as being anticipated by Duchateau et al. (WO 2006/097853 published on 09/21/2006, see IDS).
The instant claims are drawn to a method for cleaving a double-stranded DNA comprising: (a) identifying in said DNA at least one recognition site for a rationally-designed I-CreI- derived meganuclease with altered specificity relative to I-CreI, wherein said recognition site is not cleaved by a naturally-occurring I-CreI, wherein said recognition site has a four base pair central sequence selected from the group consisting of GAGT, ACGC, CCGC and GCGC; (b) providing said rationally-designed meganuclease; and (c) contacting said DNA with said rationally-designed meganuclease; whereby said rationally-designed meganuclease cleaves said DNA.
Duchateau et al. specifically teach a method for cleaving a double-stranded DNA comprising: (a) identifying in said DNA at least one recognition site for a rationally-designed I-CreI-derived meganuclease with altered specificity relative to I-CreI, i.e., KTG or AGR I-CreI variant, wherein said recognition site is not cleaved by a naturally-occurring I-CreI, wherein said recognition site has a four base pair central sequence CCGC (see line 20 of Figure 2b on page 64; and SEQ ID NOs: 13 and 52); (b) providing said rationally-designed meganuclease; and (c) contacting said DNA, which is a PCR product, or in plasmid or chromosome, with said rationally-designed meganuclease variant; whereby said rationally-designed meganuclease variant cleaves said DNA in vitro or in vivo, i.e., yeast or mammalian CHO-K1 cell, optionally further comprising rationally designing said rationally-designed meganuclease variant and producing said rationally-designed meganuclease variant (see pages 24-43 including descriptions of the figures 1-14 and Examples), thereby anticipating claims 1, 3-7, 9-10 and 26. Therefore, the reference of Duchateau et al. anticipates the Applicants’ claimed methods.
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 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, 3-7, 9-10 and 24-27 are rejected on the ground of nonstatutory double patenting over claims 1-11 of U. S. Patent No. 10287626 in view of Arnould et al. (WO 2008/010093 published on 01/24/2008, see IDS) and Duchateau et al. (WO 2006/097853 published on 09/21/2006, see IDS) since the claims, if allowed, would improperly extend the "right to exclude" already granted in the patent.
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows:
The instant claims are drawn to a method for cleaving a double-stranded DNA comprising: (a) identifying in said DNA at least one recognition site for a rationally-designed I-CreI- derived meganuclease with altered specificity relative to I-CreI, wherein said recognition site is not cleaved by a naturally-occurring I-CreI, wherein said recognition site has a four base pair central sequence selected from the group consisting of GAGT, ACGC, CCGC and GCGC; (b) providing said rationally-designed meganuclease; and (c) contacting said DNA with said rationally-designed meganuclease; whereby said rationally-designed meganuclease cleaves said DNA.
Claim 1 of ‘626 patent: A method for cleaving a double-stranded DNA comprising: (a) identifying in said DNA at least one recognition site for a rationally-designed I-CreI-derived meganuclease with altered specificity relative to I-CreI, wherein said recognition site is not cleaved by a naturally-occurring I-CreI, wherein said recognition site has a four base pair central sequence selected from the group consisting of GCAA, GCAC, and GTAA; (b) providing said rationally-designed meganuclease; and (c) contacting said DNA with said rationally-designed meganuclease; whereby said rationally-designed meganuclease cleaves said DNA.
Although the patented claim and the instant claim are the different in the recitation of four base pair central sequences, these would have been considered obvious variants based on the teachings of Arnould et al. and Duchateau et al. As noted above, Arnould et al. and Duchateau et al. teach the claimed four base pair central sequence in addition to those recited in claims of ‘626 patent (i.e., [1] Arnould et al.: GAGT shown in Table III next to SEQ ID NO: 154; ACGC shown in Table III next to SEQ ID NO: 168, GCGC shown in Table III next to SEQ ID NO: 155; and [2] Duchateau et al.: CCGC (see line 20 of Figure 2b on page 64; and SEQ ID NOs: 13 and 52)). A person of ordinary skill in the art (POSITA) would have had a reasonable expectation of success to practice such methods because all of the required biochemical reagents and techniques were readily available and rampantly used as evidenced by Arnould et al. and Duchateau et al. prior to the filing of the instant application. For the reasons provided herein, if allowed, the instant application would improperly extend the "right to exclude" already granted in the patent.
Claims 1, 3-7, 9-10 and 24-27 are rejected on the ground of nonstatutory double patenting over claims 1-11 of U. S. Patent No. 10273524 in view of Arnould et al. (WO 2008/010093 published on 01/24/2008, see IDS) and Duchateau et al. (WO 2006/097853 published on 09/21/2006, see IDS) since the claims, if allowed, would improperly extend the "right to exclude" already granted in the patent.
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows:
The instant claims are drawn to a method for cleaving a double-stranded DNA comprising: (a) identifying in said DNA at least one recognition site for a rationally-designed I-CreI- derived meganuclease with altered specificity relative to I-CreI, wherein said recognition site is not cleaved by a naturally-occurring I-CreI, wherein said recognition site has a four base pair central sequence selected from the group consisting of GAGT, ACGC, CCGC and GCGC; (b) providing said rationally-designed meganuclease; and (c) contacting said DNA with said rationally-designed meganuclease; whereby said rationally-designed meganuclease cleaves said DNA.
Claim 1 of ‘524 patent: A method for cleaving a double-stranded DNA comprising: (a) identifying in said DNA at least one recognition site for a rationally-designed I CreI-derived meganuclease with altered specificity relative to I-CreI, wherein said recognition site is not cleaved by a naturally-occurring I-CreI, wherein said recognition site has a four base pair central sequence selected from the group consisting of ACAC, ACAT, and ATAT; (b) providing said rationally-designed meganuclease; and (c) contacting said DNA with said rationally-designed meganuclease; whereby said rationally-designed meganuclease cleaves said DNA.
Although the patented claim and the instant claim are the different in the recitation of four base pair central sequences, these would have been considered obvious variants based on the teachings of Arnould et al. and Duchateau et al. As noted above, Arnould et al. and Duchateau et al. teach the claimed four base pair central sequence in addition to those recited in claims of ‘524 patent (i.e., [1] Arnould et al.: GAGT shown in Table III next to SEQ ID NO: 154; ACGC shown in Table III next to SEQ ID NO: 168, GCGC shown in Table III next to SEQ ID NO: 155; and [2] Duchateau et al.: CCGC (see line 20 of Figure 2b on page 64; and SEQ ID NOs: 13 and 52)). A person of ordinary skill in the art (POSITA) would have had a reasonable expectation of success to practice such methods because all of the required biochemical reagents and techniques were readily available and rampantly used as evidenced by Arnould et al. and Duchateau et al. prior to the filing of the instant application. For the reasons provided herein, if allowed, would improperly extend the "right to exclude" already granted in the patent.
Claims 1, 3-7, 9-10 and 24-27 are rejected on the ground of nonstatutory double patenting over claims 1-10 of U. S. Patent No. 9683257 in view of Arnould et al. (WO 2008/010093 published on 01/24/2008, see IDS) and Duchateau et al. (WO 2006/097853 published on 09/21/2006, see IDS) since the claims, if allowed, would improperly extend the "right to exclude" already granted in the patent.
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows:
The instant claims are drawn to a method for cleaving a double-stranded DNA comprising: (a) identifying in said DNA at least one recognition site for a rationally-designed I-CreI- derived meganuclease with altered specificity relative to I-CreI, wherein said recognition site is not cleaved by a naturally-occurring I-CreI, wherein said recognition site has a four base pair central sequence selected from the group consisting of GAGT, ACGC, CCGC and GCGC; (b) providing said rationally-designed meganuclease; and (c) contacting said DNA with said rationally-designed meganuclease; whereby said rationally-designed meganuclease cleaves said DNA.
Claim 1 of ‘257 patent: A method for cleaving a double-stranded DNA comprising: (a) identifying in said DNA at least one recognition site for a rationally-designed I-CreI-derived meganuclease with altered specificity relative to I-CreI, wherein said recognition site is not cleaved by a naturally-occurring I-CreI, wherein said recognition site has a four base pair central sequence selected from the group consisting of GTAT and ATGC; (b) providing said rationally-designed meganuclease; and (c) contacting said DNA with said rationally-designed meganuclease; whereby said rationally-designed meganuclease cleaves said DNA.
Although the patented claim and the instant claim are the different in the recitation of four base pair central sequences, these would have been considered obvious variants based on the teachings of Arnould et al. and Duchateau et al. As noted above, Arnould et al. and Duchateau et al. teach the claimed four base pair central sequence in addition to those recited in claims of ‘257 patent (i.e., [1] Arnould et al.: GAGT shown in Table III next to SEQ ID NO: 154; ACGC shown in Table III next to SEQ ID NO: 168, GCGC shown in Table III next to SEQ ID NO: 155; and [2] Duchateau et al.: CCGC (see line 20 of Figure 2b on page 64; and SEQ ID NOs: 13 and 52)). A person of ordinary skill in the art (POSITA) would have had a reasonable expectation of success to practice such methods because all of the required biochemical reagents and techniques were readily available and rampantly used as evidenced by Arnould et al. and Duchateau et al. prior to the filing of the instant application. For the reasons provided herein, if allowed, would improperly extend the "right to exclude" already granted in the patent.
Conclusion
Claims 1, 3-7, 9-10 and 24-27 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
The instant Office action is non-final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Prosecution Insights