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 .
d.
DETAILED ACTION
Claims 1,3, 5-11 & 13 are considered on the merits. All other claims are withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/23/25 is acknowledge
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 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.
Claims 1,3, 5-11 & 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6 of U.S. Patent No. 11814664 in view of US2010/00304453 (‘453).
Instant independent claim 1, reads (divided into two sections):
A non-naturally occurring microbial organism, said microbial organism
having a (3R)-hydroxybutyl (3R)-hydroxybutyrate pathway and comprising at least one
exogenous nucleic acid encoding a (3R)-hydroxybutyl (3R)-hydroxybutyrate pathway enzyme expressed in a sufficient amount to produce (3R)-hydroxybutyl (3R)-hydroxybutyrate, wherein said (3R)-hydroxybutyl (3R)-hydroxybutyrate pathway comprises a pathway selected from:
(1) 1A;
(2) 1B;
(3) 1C and 1E;
(4) 1D and 1E;
(5) 1F; and
(6) 1G and 1E,
wherein 1A is a (3R)-hydroxybutyl (3R)-hydroxybutyrate ester forming enzyme, wherein
1B is a (3R)-hydroxybutyryl-CoA:(R)-1,3-butanediol alcohol transferase, wherein 1C is a (3R)-hydroxybutyl 3-oxobutyrate ester forming enzyme, wherein 1D is an acetoacetyl-CoA:(R)-1,3-butanediol alcohol transferase, wherein 1E is a (3R)-hydroxybutyl 3-oxobutyrate reductase, wherein 1F is a (3R)-hydroxybutyryl-ACP:(R)-1,3-butanedidl ester synthase, wherein 1G is an acetoacetyl-ACP:(R)-1,3-butanediol ester synthase;
THE ABOVE PORTION OF CLAIM 1 (part one) IS DENTICAL TO CLAIM 1 OF THE PATENT. The below portion of the claim will be referred to as part two.
wherein the said microbial organism further comprises an (R)-1,3-butanediol pathway
and at least one exogenous nucleic acid encoding an (R)-1,3-butanediol pathway enzyme expressed in a sufficient amount to produce (R)-1,3-butanediol, wherein said (R)-1,3-butanediol pathway comprises a pathway selected from:
(a) 2B, 2C, and 2D; (b) 2B, 2H, 2I, and 2D;
(c) 2J, 2K, 2C, and 2D; (d) 2J, 2K, 2H, 2I, and 2D;
(e) 2A, 2B, 2C, and 2D; (f) 2A, 2B, 2H, 2I, and 2D;
(g) 2A, 2J, 2K, 2C, and 2D; (h) 2A, 2J, 2K, 2H, 2I, and 2D;
(i) 2E, 2F, 2B, 2C, and 2D; (j) 2E, 2F, 2B, 2H, 2I, and 2D;
(k) 2E, 2F, 2J, 2K, 2C, and 2D; (1) 2E, 2F, 2J, 2K, 2H, 2I, and 2D;
(m) 3A, 3B, and 3E;
(n) 3A, 3C, 2B, 2C, and 2D;
(o) 3A, 3C, 2B, 2H, 21, and 2D;
(p) 3A, 3C, 2J, 2K, 2C, and 2D;
(q) 3A, 3C, 2J, 2K, 2H, 2I, and 2D;
(r) 3A, 3B, 3D, 2C, and 2D;
(s) 3A, 3B, 3D, 2H, 2I, and 2D;
(t) 3A, 3B, 3G, 2I, and 2D; and
(u) 3A, 3B, 3F, and 2D,
wherein 2A is an acetoacetyl-CoA thiolase, wherein 2B is a (3R)-hydroxybutyryl-CoA
dehydrogenase, wherein 2C is a (3R)-hydroxybutyryl-CoA reductase, wherein 2D is a (3R)- hydroxybutyraldehyde reductase, wherein 2E is an acetyl-CoA carboxylase, wherein 2F is an acetoacetyl-CoA synthase, wherein 2H is a (3R)-hydroxybutyryl-CoA transferase, a (3R)- hydroxybutyryl-CoA synthetase, or a (3R)-hydroxybutyryl-CoA hydrolase, wherein 2 I is a (3R)- hydroxybutyraldehyde dehydrogenase, (3R)-hydroxybutyraldehyde oxidase or (3R)- hydroxybutyrate reductase, wherein 2J is a (3S)-hydroxybutyryl-CoA dehydrogenase, wherein 2K is a 3-hydroxybutyryl-CoA epimerase, wherein 3A is a 3-ketoacyl-ACP synthase, wherein 3B is an acetoacetyl-ACP reductase, wherein 3C is an acetoacetyl-CoA: ACP transferase, wherein 3D is a (3R)-hydroxybutyryl-CoA:ACP transferase, wherein 3E is a (3R)- hydroxybutyryl-ACP reductase (alcohol forming), wherein 3F is a (3R)-hydroxybutyryl-ACP reductase (aldehyde forming), wherein 3G is a (3R)-hydroxybutyryl-ACP thioesterase.
As indicated above the delineated first portion of instant claim 1 is identical to claim 1 of 11814664. The claims of the patent do not disclose part two of instant claim 1( or claims 5-10) however the instantly claimed microorganism would have been obvious at the time the invention was filed because it would have been obvious to include a further comprises an (R)-1,3-butanediol pathway and at least one exogenous nucleic acid encoding an (R)-1,3-butanediol pathway enzyme expressed in a sufficient amount to produce (R)-1,3-butanediol into the microorganism as claimed in claim 1of the patent because the pathway (and nucleic acids needed for it) as claimed in part two of the instant claim 1 (and claims 5-10) is fully disclosed in ‘453 [abstract] [0016] [0021] [0083] and the inclusion of the part two pathway would have been obvious because it would yield more useful products ( as set forth in 2010/0304453). It would have been obvious to combine the two known pathways as it does no more no more than yield predictable products.
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Claim 3 corresponds directly to patented claim 2. Claim 11 corresponds directly to patented claim 3. Claim 13 corresponds directly to patented claim 4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657