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 .
Status of the Application
Claims 1-2 and 6-30 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 04/14/2026 are acknowledged. Claims under consideration in the instant office action are claims 1-2 and 6-30.
Applicants' arguments, filed 04/14/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 1-2 and 6-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,154,594.
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims both recite similar compositions comprising transgenic plant material. U.S. Patent No. 11,154,594 is drawn towards a corn silage comprising seeds or kernels from a transgenic corn plant or corn plant part, wherein the transgenic com plant or com plant part comprises com event 3272, wherein the seeds or kernels comprise a recombinant a-amylase expressed in the endosperm of the seeds or kernels, wherein the recombinant a-amylase comprises an amino acid sequence having at least 99% sequence identity to the amino acid sequence of SEQ ID NO: 1; and wherein the seeds or kernels comprise from 5% to 100% by weight of the corn silage.
U.S. Patent No. 11,154,594 does not recite a method of increasing the efficiency of feed utilization for milk production by a dairy animal comprising feeding the animal with a composition comprising transgenic plant material.
It would have been obvious to one of ordinary skill in the art to increase efficiency of feed utilization for milk production in a dairy animal comprising feeding the animal with a composition comprising transgenic plant material since U.S. Patent No. 11,154,594 recites the same feed composition as the claimed invention, and the claimed invention merely recites the use of that composition, with a reasonable expectation of success absent evidence of criticality of the particular steps.
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc ., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Response to Arguments
Applicant's arguments filed 04/14/2026 have been fully considered but they are not persuasive.
Applicant argues that “statement in the Office Action that "U.S. Patent No. 11,154,594 recites the same feed composition as the claimed invention, and the claimed invention merely recites the use of that composition with a reasonable expectation of success absent evidence of criticality of the particular steps" (Office Action dated December 12, 2025 at page 5, second paragraph from bottom) is not dispositive for obviousness without an articulation reasoning with an underlying factual rationale as to why the person of ordinary skill in the art would have been motivated to use the composition of the '594 patent in the currently claimed method of increasing the efficiency of feed utilization for milk production. Moreover, no rationale whatsoever is provided as to why the person of ordinary skill would have had a reasonable expectation of success and, as summarized above, Applicants have previously submitted arguments, a third-party publication, and a declaration under 37 C.F.R. § 132, all providing a factual basis as to why the presently claimed invention is non-obvious and there could have been no reasonable expectation of success.” The Examiner respectfully disagrees since a method of increasing efficiency of feed utilization can encompass increasing milk production derived from such feed since, for example, the instant specification discloses that weight gain and efficiency can be increased comprising the same method of feeding an animal the feed composition as recited (pg. 37, lines 21-23; see pg. 85, Table 21). Thus, increasing efficiency and increasing production are not completely separate parameters wherein it would be obvious to increase efficiency by administering the recited composition. Furthermore, the ‘594 patent recites the same method of increasing efficiency as the claimed invention (col. 2, lines 38-42).
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc ., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Regarding the Weyers Declaration, although increased milk production does not on its own indicate higher feed efficiency, increased milk production arising from the same or a reduced amount of feed would result in a higher feed efficiency. Increased milk production and higher feed efficiency are thus not separate parameters. The instantly claimed use of the feed composition recited in U.S. Patent No. 11,154,594 thereby overlaps with the use of that feed composition recited in U.S. Patent No. 11,154,594.
Applicant also argues that “The relevance of this statement is unclear since the outstanding rejection is no longer based on the disclosure in the '594 patent of methods of using the compositions claimed in the '594 patent in a method of increasing milk production. Further, it again fails to address why the presently claimed methods of increasing the efficiency of feed utilization for milk production by a dairy animal would be obvious in view of the '594 patent.” The Examiner respectfully disagrees since the ‘594 patent discloses the same method of increasing efficiency as the claimed invention (col. 2, lines 38-42).
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc ., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Applicant also argues that “The '594 patent discloses methods for increasing feed efficiency in the context of body weight gain ('594 patent at col 22, lines 44-46 and col. 23, lines 39-42), as exemplified in the working examples by steers in a finishing feedlot. However, the '594 patent does not in any way disclose or suggest the use of an animal feed to increase the efficiency of feed utilization for milk production by a dairy animal as claimed in the instant application.” The Examiner respectfully disagrees since the disclosure of increasing feed efficiency is not limited to specific efficiencies.
Applicant also argues that “Even assuming, arguendo, that the Office had established a prima facie case of OTDP (which it has not), the claimed invention is nevertheless nonobvious in view of the objective evidence of unexpected results.” The Examiner respectfully disagrees since it would be expected that feed efficiency would be increased since the ‘594 patent recites the same product used in the claimed invention and also discloses methods of increasing the efficiency of such feed (col. 2, lines 38-42).
Conclusion
Claims 1-2 and 6-30 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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