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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/23/2025 has been entered.
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 10/23/2025 are acknowledged. Claims under consideration in the instant office action are claims 1-2 and 6-30.
Applicants' arguments, filed 10/23/2025, have been fully considered but they are not deemed to be persuasive. The nonstatutory double patenting rejection of claims 1-2 and 6-30 over U.S. Patent No. 11,793,216 is withdrawn since the present application is a divisional of Application No. 16/650,526. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/23/2025 was filed after the mailing date of the Final Rejection on 07/16/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 2 is 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 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: claim 2 does not provide a basis for the numerical determination regarding “the efficiency of feed utilization for milk production is increased by at least 0.02 as compared with the efficiency of feed utilization for milk production by a control animal that is not provided the animal feed.”
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 10/23/2025 have been fully considered but they are not persuasive.
Applicant argues that “an increase in the efficiency of feed utilization for milk production in a dairy animal is not obvious based on the teachings of an increase in milk production. These are separate parameters, and an increase in milk production can be accompanied by a decrease, an increase, or no change in feed efficiency.” The Examiner respectfully disagrees since U.S. Patent No. 11,154,594recites the same product as recited in the claimed invention, and the claimed invention is merely drawn towards the use of that product. Additionally, 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). Additionally, there is no per se prohibition on NSDP across statutory categories. See MPEP 804.
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 “Further, an increase in feed efficiency is valuable to a dairy producer even if milk production stays the same or is even decreased because the feed cost per unit of milk produced is improved.” The Examiner respectfully disagrees since although the Shaver declaration asserts that “it is not obvious that an increase in milk yield (e.g., as described in the '594 patent)
will be associated with increased feed efficiency” as seen in the study conducted at The Pennsylvania State University (Shaver Declaration, point 2) and the use of BMR corn silage (Shaver Declaration, point 3), the feed of U.S. Patent No. 11,154,594 differs in that U.S. Patent No. 11,154,594 recites the same feed as recited in the claimed invention. Additionally, an increase in milk yield can be achieved without an increase in feed amount given that U.S. Patent No. 11,154,594 does not recite an increase in the amount of feed. Furthermore, U.S. Patent No. 11,154,594 teaches a method of increasing the efficiency of feed utilization comprising feeding to an animal the feed composition recited (see abstract; col. 24, lines 6-15). Regarding the financial benefit of the claimed invention, an increase of milk yield arising from the claimed feed composition would naturally result in increased revenue due to the increased milk yield from the same cost of feed since the amount of feed composition is not increased.
Conclusion
Claims 1-2 and 6-30 are rejected.
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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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691