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 1-15 are pending and examined herein on the merits.
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.
Claims 2, 3 and 14 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. The claims recite a Table reference in the claims which is considered an improper incorporation by reference. The claims must have the relevant information from the Table recited within the claim where possible.
2173.05(s) Reference to Figures or Tables [R-08.2012]
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Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
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Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 7-8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Johnson et al (US Patent 8093453).
The claims are drawn to methods of producing maize grain comprising contacting a pollen recipient plant with a pollen formulation and harvesting grain comprising at least one genetically modified locus which confers an improved grain fuel trait including amylase as in corn event 3272 (in Table 1 of the instant specification), wherein the pollen formulation is a blend of pollen donor sources wherein the formulation is adapted for storage OR for fertilization, and wherein the pollen recipient is an F1 hybrid.
Johnson et al teach transgenic corn event 3272 which alters the amylose composition and improves a grain fuel trait and teach crossing the plant with itself or another corn plant, specifically it was crossed to inbred corn lines NP911x and NP2222x, which were then self-pollinated, this means that the event was crossed in F1 pollen donor seeds which would inherently comprise a blend of pollen sources as F1 progeny would have independent assortment and also would constitute a cross to an F1 recipient (see example 1).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Witherspoon et al (USPGPUB 20200230215).
The claims are drawn to a grain lot which is a population of grain comprising harvested grain comprising grain (which is seed) comprising a recipient plant genome and a paternal plant genome wherein the paternal plant genome comprises at least one modified locus conferring an improved grain fuel trait including corn even 3272 contained within Table 1 of the instant specification. It is noted that in the case of claims 12-14, the recipient locus could also be of event 3272 as there are no limitations against this and accordingly, read on corn event 3272 seed. It is also noted that claims 11 and 15 do not actually require any modified grain at all as through natural Mendelian inheritance and crossing over, it encompasses grain that would not possess the 3272 event or otherwise modified corn.
Witherspoon et al teach animal feed and a method utilizing said animal feed wherein a portion of the population of grains (a grain lot) is corn modified by transgenic event 3272, the same even contained in Table 1 of the instant specification and a portion that is non-event grain. In addition to meeting the limitation of the claims as written, as discussed above, it is further noted that there is no requirement in Witherspoon for the transgenic event to be homozygous and therefore would inherently also read just on the event itself on grain produced by the method of claims 1-3 at least and therefore read on the claims drawn to the grain lot. It is further revealed in Witherspoon et al, that the event reads on the amylase limitations of the instant claims as well (see claim 1 as well as background).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al (US Patent 8093453) in view of Streatfield et al (USPGPUB20110091976), in view of Witherspoon et al Witherspoon et al (USPGPUB 20200230215).
The claims are drawn to methods of producing maize grain comprising contacting a pollen recipient plant with a pollen formulation and harvesting grain comprising at least one genetically modified locus which confers an improved grain fuel trait including amylase as in corn event 3272 (in Table 1 of the instant specification), wherein the pollen formulation is a blend of pollen donor sources wherein the pollen donor is located at more than at least 200, 400, 600, 800 or 1,000 meters from the pollen recipient, wherein the contact is mechanically mediated, wherein the formulation is adapted for storage OR for fertilization, wherein the pollen recipient is an F1 hybrid and processing the grain as well as grain lots as outlined above.
Johnson et al teach transgenic corn event 3272 which alters the amylose composition and improves a grain fuel trait and teach crossing the plant with itself or another corn plant, specifically it was crossed to inbred corn lines NP911x and NP2222x, which were then self-pollinated such that the event was crossed then to an F1 recipient (see example 1).
Johnson et al do not explicitly teach mechanical pollination or a specific distance between plants.
Streatfield et al teach that it is routine in the art at the time of filing to include mechanical means of pollination as a means of pollination in corn breeding (see 42nd paragraph under Description of Embodiments). It is also noted that plant distance would be an obvious design choice when choosing to use mechanical means for pollination since the pollen is applied by mechanical means.
Witherspoon et al teach animal feed and a method utilizing said animal feed wherein a portion of the population of grains (a grain lot) is corn modified by transgenic event 3272, the same even contained in Table 1 of the instant specification and a portion that is non-event grain. In addition to meeting the limitation of the claims as written, as discussed above, it is further noted that there is no requirement in Witherspoon for the transgenic event to be homozygous and therefore would inherently also read just on the event itself on grain produced by the method of claims 1-3 at least and therefore read on the claims drawn to the grain lot. It is further revealed in Witherspoon et al, that the event reads on the amylase limitations of the instant claims as well (see claim 1 as well as background).
Given the state of the art, the disclosures by Johnson et al, Streatfield et al and Witherspoon et al it would have been obvious for one of skill in the art to practice the instantly claimed methods by normative use of corn for corn event 3272 and crossing it with recipient corn varieties including F1 as taught by Johnson et al using mechanical pollination as taught by Streatfield et al and one of ordinary skill in the art would have been motivated to do so to prevent cross contamination of pollen as taught by Streatfield et al. The grain lots would have been an automatic result of these crosses and harvesting of seed.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18722517. Although the claims at issue are not identical, they are not patentably distinct from each other because they have overlapping subject matter both being drawn to methods and grain lots comprising modified corn wherein amylase may be modified.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663