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 .
The objections to claims 2, 9 & 14 are withdrawn in light of Applicant’s amendments.
The rejection of claim(s) 1-3, 5, 8, 9, 10, 12-14 & 16-17 under 35 U.S.C. 103 as being unpatentable over Lanahan et al (US 7,557,262 B2) in view of Meis et al (WO 2010/025213 A1), taken with the evidence of Jung et al (2004) Crop Sci. 44:1781–1789. and Krier (US 5,731,503 A) is withdrawn in light of Applicant’s amendments.
The rejection of claim(s) 1-3, 7-10, 12-14 & 16-17 under 35 U.S.C. 103 as being unpatentable over Lanahan, taken with the evidence of Jung and Krier, and in view of Cope et al (US 11,166,421 B2) is withdrawn in light of Applicant’s amendments.
The rejection of claim(s) 1-3, 6-10, 12-14 & 16-17 under 35 U.S.C. 103 as being unpatentable over Lanahan, as evidenced by Jung and Krier, and in view of Cope, and further in view of Della Porta (2008) Europ. J. Agronomy. 28. 255–265 is withdrawn in light of Applicant’s amendments.
The rejection of claim(s) 1-3, 8-10, 11-14 & 16-17 under 35 U.S.C. 103 as being unpatentable over Lanahan, taken with the evidence of Jung and Krier, in view of Johnson (2020) Cattlemen’s Day. 6(2). 7. is withdrawn in light of Applicant’s amendments.
Status of Claims
Claims 1-3, 5-14, & 16-17 are under examination on the merits.
Claims 4 & 15 are withdrawn with traverse.
Claim Interpretation
Claim 13 recites grain comprising a maize pollen recipient plant genome and a paternal genome comprising at least one genetically modified locus which confers an improved grain feed trait. Because there is no comma between “paternal genome” and “comprising at least one genetically modified locus”, claim 13 is interpreted to require at least one genetically modified locus within the paternal genome specifically not merely in the grain. Because there is no comma between “genetically modified locus” and “which confers an improved grain feed trait”, claim 13 is interpreted to require that the genetically modified locus of the paternal genome confers an improved grain feed trait.
The specification does not provide a specific definition of a pollen formulation, and so this limitation in claims 1, 5 & 9 has been broadly interpreted to encompass any composition comprising pollen. Because the specification defines “configured” as capable of performing a task and that “configured” can be used interchangeably with “adapted” (paragraph [0031]), claim 9 has been interpreted to mean the formulation is capable of storage and/or fertilization of a maize pollen recipient plant.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claims 1-3, 5-14, 16-17 are 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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 10/30/2025 as applied to claims 1-3, 5-14, & 16-17. Applicant' s arguments filed 1/26/2026 have been fully considered but they are not persuasive.
The term “improved” in claim 1 (line 3), claim 2 (line 2), claim 13 (line 3), and claim 14 (line 2) is a relative term which renders the claim indefinite. The term “improved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 2 & 14 recite options for the “improved” grain feed trait, including phytase content, protein level, starch content, amylase content, phosphorous content, etc. Conceivably, an improved grain feed trait could comprise an increase, a decrease, or a change in chemical features for the provided traits. Secondly, the disclosure does not specify what the improvement is relative to, whether it’s the pollen recipient plant, the paternal plant, both, or some other standard. Because neither the nature nor degree of the improvement is defined, claims 1-3, 5-14, 16-17 are indefinite.
Applicant urges that the term “improved” is not indefinite in the context of the claims and the specification. Applicant urges that claims 2 and 14 provide a specific list of traits that constitute the “improved grain feed trait” and that one of skill in the art would understand that an “improved” trait refers to a modification in one of these characteristics that provides a benefit for grain feed applications. Applicant points to guidance in the specification regarding the nature of these improvements. Applicant urges that the meaning of a claim should be what would be reasonable from the perspective of one of ordinary skill in the art and urges that one of ordinary skill would understand what traits are encompassed and that “improved” refers to a beneficial modification of those traits for feed purposes (Remarks, page 7, paragraph 2-page 8, paragraph 2).
This argument is unpersuasive, because claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant. During examination, a claim must be given its broadest reasonable interpretation consistent with the specification (MPEP 2173.01(I)). In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1369, 70 USPQ2d 1827, 1834 (Fed. Cir. 2004) ("We have cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification."). The broadest reasonable interpretation of claim 1 and claim 13 is that “improved grain feed trait” may encompass traits not provided in claims 2 and 14 or the specification.
Furthermore, the disclosure does not specify what the improvement in the grain feed trait is relative to. Wording to provide a standard for ascertaining the requisite degree, for example “as compared to grain not comprising the at least one genetically modified locus”, would be necessary to define the scope of the instant claims.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 12-14 & 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lanahan et al (US 7,557,262 B2, patented 7/7/2009, hereafter Lanahan) taken with the evidence of Jung et al (2004) Crop Sci. 44:1781–1789 (published 9/2004, hereafter Jung) and Krier (US 5,731,503 A, patented 3/24/ 1998; hereafter Krier).
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 10/30/2025 as applied to claims 1-3, 8-10, 12-14 & 16-17. Applicant' s arguments filed 1/26/2026 have been fully considered but they are not persuasive.
Claims 12-14 & 16-17 are drawn to a grain lot comprising grain comprising a recipient plant genome and a paternal genome comprising at least one genetically modified locus which confers an improved grain feed trait, as well as a grain lot or single grain obtained by a method of contacting a pollen recipient plant with a pollen formulation and harvesting grain comprising at least one genetically modified locus which confers an improved grain feed trait.
Lanahan discloses an α-amylase with a desired activity profile for hyperthermophilic starch processing with a sequence of Lanahan SEQ ID NO: 1 that comprises a sequence with 100% sequence identity to instant SEQ ID NO: 2 (column 48, lines 13-25). See alignment below.
Score
Expect
Method
Identities
Positives
Gaps
883 bits(2282)
0.0
Compositional matrix adjust.
436/436(100%)
436/436(100%)
0/436(0%)
Query 1 MAKYLELEEGGVIMQAFYWDVPSGGIWWDTIRQKIPEWYDAGISAIWIPPASKGMSGGYS 60
MAKYLELEEGGVIMQAFYWDVPSGGIWWDTIRQKIPEWYDAGISAIWIPPASKGMSGGYS
Sbjct 1 MAKYLELEEGGVIMQAFYWDVPSGGIWWDTIRQKIPEWYDAGISAIWIPPASKGMSGGYS 60
Query 61 MGYDPYDYFDLGEYYQKGTVETRFGSKQELINMINTAHAYGIKVIADIVINHRAGGDLEW 120
MGYDPYDYFDLGEYYQKGTVETRFGSKQELINMINTAHAYGIKVIADIVINHRAGGDLEW
Sbjct 61 MGYDPYDYFDLGEYYQKGTVETRFGSKQELINMINTAHAYGIKVIADIVINHRAGGDLEW 120
Query 121 NPFVGDYTWTDFSKVASGKYTANYLDFHPNELHAGDSGTFGGYPDICHDKSWDQYWLWAS 180
NPFVGDYTWTDFSKVASGKYTANYLDFHPNELHAGDSGTFGGYPDICHDKSWDQYWLWAS
Sbjct 121 NPFVGDYTWTDFSKVASGKYTANYLDFHPNELHAGDSGTFGGYPDICHDKSWDQYWLWAS 180
Query 181 QESYAAYLRSIGIDAWRFDYVKGYGAWVVKDWLNWWGGWAVGEYWDTNVDALLNWAYSSG 240
QESYAAYLRSIGIDAWRFDYVKGYGAWVVKDWLNWWGGWAVGEYWDTNVDALLNWAYSSG
Sbjct 181 QESYAAYLRSIGIDAWRFDYVKGYGAWVVKDWLNWWGGWAVGEYWDTNVDALLNWAYSSG 240
Query 241 AKVFDFPLYYKMDAAFDNKNIPALVEALKNGGTVVSRDPFKAVTFVANHDTDIIWNKYPA 300
AKVFDFPLYYKMDAAFDNKNIPALVEALKNGGTVVSRDPFKAVTFVANHDTDIIWNKYPA
Sbjct 241 AKVFDFPLYYKMDAAFDNKNIPALVEALKNGGTVVSRDPFKAVTFVANHDTDIIWNKYPA 300
Query 301 YAFILTYEGQPTIFYRDYEEWLNKDKLKNLIWIHDNLAGGSTSIVYYDSDEMIFVRNGYG 360
YAFILTYEGQPTIFYRDYEEWLNKDKLKNLIWIHDNLAGGSTSIVYYDSDEMIFVRNGYG
Sbjct 301 YAFILTYEGQPTIFYRDYEEWLNKDKLKNLIWIHDNLAGGSTSIVYYDSDEMIFVRNGYG 360
Query 361 SKPGLITYINLGSSKVGRWVYVPKFAGACIHEYTGNLGGWVDKYVYSSGWVYLEAPAYDP 420
SKPGLITYINLGSSKVGRWVYVPKFAGACIHEYTGNLGGWVDKYVYSSGWVYLEAPAYDP
Sbjct 361 SKPGLITYINLGSSKVGRWVYVPKFAGACIHEYTGNLGGWVDKYVYSSGWVYLEAPAYDP 420
Query 421 ANGQYGYSVWSYCGVG 436
ANGQYGYSVWSYCGVG
Sbjct 421 ANGQYGYSVWSYCGVG 436
Lanahan discloses expression cassettes comprising a gene encoding this amylase protein (column 49, lines 62-column 50 line 29) and discloses the coding sequence under control of a promoter for endosperm specific expression in maize (column 49, lines 44-55). Lanahan discloses a maize transformation vector (column 50, lines 58-column 51, line 3), the expression cassettes moved into a binary vector for Agrobacterium transformation of maize (column 53, lines 3-5), and the method of transformation of maize with these constructs (column 54, lines 34-46). Plants comprising constructs for α-amylase were self-pollinated or outcrossed and seed was collected for analysis (column 50, lines 30-38). Lanahan discloses plants created by cross pollinating two different transgenic lines in order to express both α-amylase and pullulansase (column 13, lines 21-32; figure 13A, 13B).
T1 seed from self-pollinated transformants had normal starch accumulation but when placed in 85°C water bath, 75% of kernels had starch degradation (column 54, line 53-column 55, line 12). Lanahan discloses that in T1 seed of transgenic maize with α-amylase targeted to amyloplast, kernels had very low or no starch and after heat treatment starch was degraded (column 55, line 64-column 56, line 8).
Lanahan also discloses pollinating a commercial hybrid corn line (N3030BT) with a transgenic line expression thermostable α-amylase to produce corn (column 56, lines 31-43). After drying the corn to 11% moisture and storage at room temperature, the obtained corn was subjected to grinding, liquefaction, and fermentation (column 56, lines 34-column 57, line 21).
Lanahan envisions that transgenic corn can be mixed with control corn and have good performance in ethanol production from 5% to 40% of the mixture (column 59, lines 6-23) and envisions the production of fructose from flour using this corn (column 60, lines 32-67). Lanahan discloses that after hydrolysis of corn flour from ground kernel, the residual solids have feed value as they contain proteins and other components (column 3, lines 2-4).
Jung provides evidence that N3030Bt is a hybrid with the Bt11 cry1 Ab transgenic event (page 1782, left column, paragraph 2).
Krier provides evidence that N3030 is an F1 hybrid (abstract).
The corn produced by Lanahan’s method of pollinating a commercial hybrid corn line, which does not comprise the α-amylase transgene, with a transgenic line expressing thermostable α-amylase to produce corn reads on a method of producing maize grain comprising contacting a pollen recipient plant with a pollen formulation and harvesting grain comprising a genetically modified locus which confers and improved grain feed trait, wherein the grain feed trait is amylase content, and wherein the locus encodes an amylase protein comprising instant SEQ ID NO: 2 reads on a grain lot comprising harvested grain comprising a pollen recipient plant genome and a paternal genome comprising at least one genetically modified locus which confers an improved grain feed trait, wherein the trait is amylase content, and wherein the locus comprises an amylase gene encoding an amylase protein comprising instant SEQ ID NO: 2 (instant claims 13, 14 & 16).
Claims 12 & 17 are product by process claims, which are not limited to the manipulations of the recited steps but only the structure implied by the steps (MPEP 2113(I)). The limitation of obtaining a pollen formulation from a donor source produced at a separate site would not necessarily confer structure or biological features on the produced grain or grain lot obtained by the method of claim 1 that would make them patentably distinct from grain or a grain lot obtained by the method disclosed by Lanahan. Thus, the corn obtained by Lanahan’s method of pollinating a commercial hybrid corn line, which does not comprise the α-amylase transgene, with a transgenic line expressing thermostable α-amylase, anticipates a grain lot (claim 12) and anticipates a single grain of the grain lot (claim 17).
Although Lanahan is silent as to whether the hybrid pollen recipient plant is male sterile and incapable of self-fertilization, because claims 12 and 17 are product by process claims, the grain lot of claim 12 encompasses a grain lot comprising both harvested grain that comprises the genetically modified locus as well as harvested grain that does not comprise the genetically modified locus. A mixed grain lot comprising grain both with and without a genetically modified locus is encompassed by instant claim 12 as long as at least some of the grain in the lot was obtained by the method of instant claim 1. Thus, the grain lot of claim 12 encompasses even grain lots comprising grain harvested by the method of instant claim 1 mixed with grain harvested by another method of crossing.
Because claim 17 encompasses grain lots comprising some individual grains without a genetically modified locus, a single grain that does not comprise a genetically modified locus would be encompassed by instant claim 17. A grain resulting from the claimed method of crossing that does not comprise a genetically modified locus would not comprise any markedly different characteristics from any other grain produced by any other method of crossing the pollen recipient plant with a pollen donator that differs at the genetically modified locus, because the improved grain trait of instant claim 1 is conferred by the genetically modified locus. Thus, the single grain without the genetically modified locus would not comprise any biological or phenotypic properties not found in another grain of the same genetic background. See MPEP 2106.04(c)(II).
Thus, Lanahan, taken with the evidence of Jung and Krier, anticipates claims 12-14 & 16-17.
Applicant urges that Lanahan fails to disclose a method wherein the pollen formulation is obtained from a pollen donor source produced at a site separate from the field where the pollen recipient plant is grown. Applicant urges that this is a key distinguishing feature that enables the transfer of traits through pollination from pollen produced outside of the field. Applicant urges that claims 2-3, 8-10, 12 & 17 which depend on claim 1 are allowable for the same reason as claim 1 (Remarks, page 8, paragraph 4-page 9, paragraph 3).
This argument is unpersuasive, because claims 12 & 17 are product by process claims. Although Lanahan is silent as to whether the pollen used for the method is obtained from a donor source at a site separate from the field where in the pollen recipient plant is grown, or even whether the recipient plant is grown in a field, the location of the donor source of the pollen would not impart structural or functional characteristics on the grain lot or single grain produced by the method that would make them patentably distinct from a grain lot or single grain produced from a method where the pollen donor source is not grown separately.
Applicant urges that the grain lot of claim 13 results from a method wherein pollen is obtained from a donor source produced at a separate site from the recipient plant’s field, which is not disclosed by Lanahan. Applicant urges that dependent claims 14 and 16 are allowable for the same reasons (Remarks, page 9, paragraph 4-page 10, paragraph 1).
This argument is unpersuasive, because claim 13 does not require pollen obtained from a donor source produced at a separate site from the recipient plant’s field.
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.
Claim(s) 1-3, 6-10, 12-14 & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lanahan et al (US 7,557,262 B2, patented 7/7/2009, hereafter Lanahan) in view of Cope et al (US 11,166,421 B2, patented 11/9/2021, hereafter Cope) and Della Porta (2008) Europ. J. Agronomy. 28. 255–265 (published April 2008, hereafter Della Porta) and taken with the evidence of Jung et al (2004) Crop Sci. 44:1781–1789. (published 9/2004, hereafter Jung) and Krier (US 5,731,503 A, patented 3/24/ 1998; hereafter Krier).
Claims 1-3, 6-10, 12-14 & 16-17 are drawn to a method comprising contacting a pollen recipient plant with a pollen formulation and harvesting grain comprising at least one genetically modified locus which confers and improved grain feed trait wherein the pollen recipient plant lacks said genetically modified locus and wherein the pollen formulation is obtained from a source produced at a site separate from the field where the pollen recipient is grown, as well as a grain lot comprising grain comprising a recipient plant genome and a paternal genome comprising at least one genetically modified locus which confers an improved grain feed trait.
This is a New Rejection in light of Applicant' s amendment of the claims. Applicant's arguments filed 1/26/2026 have been fully considered below as they relate to the rejection, but they are not persuasive.
The teachings of Lanahan, Jung, and Krier are presented above. They are silent as to whether the pollen formulation is obtained from a pollen donor source produced at a site separate from the field where the pollen recipient is grown. They do not teach that the pollination is accomplished by mechanical mediated means, the maize pollen formulation is a blend of pollen donor sources, or that the pollen donor is more than 200 meters from the pollen recipient.
Cope teaches a method of pollen delivery by mechanical device or by field driven machinery (column 11, lines 24-33; Cope claim 7) as well as methods of pollination by hand (column 8, lines 49-52). Cope teaches a motivation to use these delivery methods instead of natural pollination because they reduce the amount of pollen needed (column 11, lines 57-62).
Cope teaches the method of pollen selection as beneficial to starch production modification and teaches a method wherein applied male pollen influences grain starch composition of the grain harvested (table 1, claim 18).
Cope teaches an example wherein a producer plants a corn female receiver for pollen and based on market conditions, places an order for pollen containing genes that will confer traits for the desired market, including delivery of GMO grain characteristics (column 21, lines 27-60). Cope teaches a motivation to deliver traits in the grain via a GMO source of pollen, because the method would enable delivery of GMO grain characteristics without the common concern of negative effects found in conventional GMO plants and to circumvent the hurdle of getting a beneficial GMO to market (column 21, lines 50-60). Cope describes the acquisition of male pollen from a pollen bank (column 8, line 59-column 9, line 16).
Cope teaches the method of pollen selection wherein pollen is obtained from multiple genetic sources and combined prior to application (Cope claim 20). Cope teaches the method of pollen delivery wherein the pollen is preserved (Cope claim 9). Cope envisions methods in which a producer uses a variety to pollinate a crop which would not normally reach maturity or be grown in the producer’s climate (column 15, lines 47-60).
Della Porta teaches that U.S. guidelines for isolation of genetically modified maize requires 1600m for fields planted at the same time or 800 m for fields planted with a 4-week time-shift (page 256, left column, paragraph 3).
Before the time of filing of the instant application, it would have been obvious to one of ordinary skill in the art to modify the method of Lanahan to incorporate Cope’s method of pollination using machinery to apply pollen with the desired α-amylase genetically modified locus. One of ordinary skill would have been motivated to use mechanical means for pollination to increase efficiency and reduce the amount of pollen needed as compared to natural pollination. One of ordinary skill in the art would have had reasonable expectation of success, because both methods teach pollination in maize.
Although Cope specifically teaches pollination using machinery, under the broadest reasonable interpretation, contacting that is “mechanically mediated” (claim 7) also encompasses any contact by physical force, such as hand pollination, which is also taught by Cope.
In addition, before the filing date of the instant application, one of ordinary skill in the art would have been motivated to modify the methods of Lanahan to ensure than the genetically modified pollen donor plant is grown more than 200 meters from the pollen recipient, which reads on the pollen formulation obtained from a pollen donor source produced at a site separate from the field where in the pollen recipient plant is grown. One of ordinary skill in the art would have been motivated to plant the genetically modified pollen donor at least 800 meters away from the non-genetically modified pollen recipient plant in order to have the ability to decide in real time whether to use the genetically modified pollen or another, non-genetically modified pollen based on market demand. One of ordinary skill in the art would have had reasonable expectation of success, because the 800 m distance is the recommended distance to prevent gene flow from genetically modified maize. In light of Della Porta, instant claim 6 is obvious.
In light of Cope and Della Porta, Lanahan’s method of pollinating a commercial hybrid corn line, which does not comprise the α-amylase transgene, with a transgenic line expressing thermostable α-amylase to produce corn reads on a method of producing maize grain comprising contacting a pollen recipient plant with a pollen formulation and harvesting grain comprising a genetically modified locus which confers and improved grain feed trait, wherein the grain feed trait is amylase content, and wherein the locus encodes an amylase protein comprising instant SEQ ID NO: 2 (instant claims 1-3). Because N3030Bt is an F1 hybrid, the method reads on instant claim 8. Because the transgenic pollen used to pollinate the hybrid corn line successfully produced transgenic corn, the method reads on instant claim 9, wherein the pollen formulation is adapted for fertilization of a maize pollen recipient plant. See Claim Interpretation section above. Storage of the harvested corn at room temperature and 11% moisture reads on containing the grain (instant claim 10), because uncontained grain would not have a consistent temperature and humidity. Claims 12-14 & 16-17 are obvious over Lanahan as presented above.
Lanahan, as evidenced by Jung and Krier, and Cope and Della Porta make obvious claims 1-3, 6-10, 12-14 & 16-17.
Applicant urges that Cope does not cure the deficiencies of Lanahan to teach every limitation because Cope’s focus is on yield improvement through heterosis, not on delivering genetically modified feed traits to a non-modified recipient plant through pollen obtained from a separately produced donor source. Applicant urges that even though Cope describes acquisition of pollen from a pollen bank, Cope’s teaching is directed to yield improvement through heterosis not to delivering genetically modified feed traits to bypass introgression. Applicant urges that claim 1 requires contacting a pollen recipient plant that lacks the genetically modified locus with a pollen formulation wherein the harvested grain comprises the genetically modified locus which confers an improved grain feed trait and that this is not taught by Lanahan and Cope (Remarks, page 11, paragraph 2-page 12, paragraph 1).
This argument is unpersuasive, because Cope explicitly teaches that the method could be used to deliver traits in the grain and that the desired characteristic could be achieved via a GMO source of pollen and even teaches a motivation to do so, namely that the method would enable delivery of GMO grain characteristics without the common concern of negative effects found in conventional GMO plants and to circumvent the hurdle of getting a beneficial GMO to market (column 21, lines 50-60). Cope’s motivation with respect to heterosis do not negate Cope’s teachings regarding pollinating a pollen recipient plant with a GMO source of pollen to deliver traits in the grain. The motivation of the prior art does not have to be Applicant’s own in order for the combination of references to be obvious. In combination with Della Porta, which teaches a motivation to grow pollen recipient plants in a field at least 800m from genetically modified maize, which reads on a site separate from the field where the pollen recipient plant is grown, the instant claims are obvious.
Applicant urges that Della Porta does not cure the deficiencies of Lanahan and Cope because Della Porta teaches isolation distances to prevent unintended gene flow rather than intentionally delivering genetically modified feed traits through pollen. Applicant urges that Lanahan, Cope, and Della Porta fail to teach or suggest the limitations of amended claim 1 (Remarks, page 12, paragraph 2).
This argument is unpersuasive, because Lanahan, Cope, and Della Porta do teach the limitations of amended claim 1, as presented in the rejection and responses above. Della Porta’s teachings of growing corn fields at isolation distances would be motivated by the teachings of Cope to wait until pollination to make production decisions and to deliver GMO grain characteristics without the common concern of negative effects found in conventional GMO plants and to circumvent the hurdle of getting a beneficial GMO to market. If the pollen recipient plant was not grown at least at isolation distance from the pollen donor source, then Cope’s method of choosing pollen source based on market conditions would not be possible.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lanahan, Cope and Della Porta, taken with the evidence of Jung and Krier, as applied to claims 1-3, 6-10, 12-14 & 16-17 above, and further in view of Johnson (2020) Cattlemen’s Day. 6(2). 7. Published in 2020, hereafter Johnson).
This is a New Rejection in light of Applicant' s amendment of the claims. Applicant's arguments filed 1/26/2026 have been fully considered below as they relate to the rejection, but they are not persuasive.
Claim 11 is drawn to the method of producing maize grain further comprising processing the grain to provide an animal feed component.
The teachings of Lanahan, Cope, and Della Porta are presented above and incorporated herein. They do not teach processing the grain to provide an animal feed component.
Johnson teaches a method of feeding Holstein steers a diet comprising corn from a variety expressing α-amylase and either processed by dry rolling or as whole-corn (page 1, paragraph 2--page 2, paragraph 1). The corn comprising the amylase trait improved dry matter digestibility, improving feed efficiency in calves (page 2, paragraph 3).
Before the filing of the instant application, it would have been obvious to one of ordinary skill in the art to modify the method of Lanahan, Cope, and Della Porta to further process the transgenic corn comprising a locus encoding an α-amylase to provide an animal feed component. One of ordinary skill would have been motivated to process the grain to provide animal feed, because corn comprising an α-amylase trait improves feed efficiency in calves. One of ordinary skill would have had reasonable expectation of success, because both Lanahan and Johnson were using transgenic maize expressing α-amylase.
Claims 1-3, 6-14 & 16-17 are obvious over Lanahan, Cope, Della Porta and Johnson.
Applicant urges that Johnson does not cure the deficiencies of Lanahan because Johnson does not teach a method wherein pollen is obtained from a donor source produced at a site separate from the field where the pollen recipient is grown (Remarks, page 12, paragraph 3).
This argument is unpersuasive, because the limitation of pollen obtained from a donor source produced at a site separate from the field where the pollen recipient is grown is obvious over Lanahan, Cope, and Della Porta as presented above.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lanahan, Cope and Della Porta, taken with the evidence of Jung and Krier, as applied to claims 1-3, 6-10, 12-14 & 16-17 above, and further in view of Meis et al (WO 2010/025213 A1, published 3/4/2010), hereafter Meis.
This is a New Rejection in light of Applicant' s amendment of the claims. Applicant's arguments filed 1/26/2026 have been fully considered below as they relate to the rejection, but they are not persuasive.
Claim 5 is drawn to the method wherein the maize pollen formulation is a blend of pollen donor sources.
The teachings of Lanahan, Cope, and Della Porta are presented above. Lanahan additionally teaches that corn flour samples of α-amylase transgenic corn mixed with pullulanase transgenic corn have increased rate of starch hydrolysis and increased yield of fermentable oligosaccharides compared to corn flour samples comprising α-amylase transgenic corn mixed with non-transgenic corn (column 64, line 57-column 65, line 5).
Lanahan does not teach a method wherein the pollen is a blend of pollen donor sources.
Meis teaches that the economic value of commodity grains is dependent on the amounts and types of starches, oils, and proteins and that additional value can be sought by modifying characteristics to increase efficiency of processing (paragraph [0003]). Meis teaches that high value traits are typically associated with reduced plant vigor, grain yield, or seed viability (paragraph [0004]).
Meis teaches that starch mutants in corn are more readily fermented to ethanol but have less competitive yields because of poor germination and lack of seedling vigor (paragraph [00100]). Meis teaches a method wherein hybrid grain parents are crossed with blends of materials that have smaller starch granule size to produce grains that produce more ethanol than grain from normal counterparts, enhancing efficiency (paragraph [00102, 00109]).
Meis also envisions an embodiment of hybrids or inbreds that are transgenic for at least one gene that impacts starch fermentability, and this hybrid can be used as a pollinator in blends (paragraph [00113]).
Meis teaches a method for producing high oil corn with improved starch fermentation by crossing with HOI002 (paragraphs [00119-00120]). Meis envisions an embodiment wherein at least one transgene conferring high oil and one transgene affecting starch fermentability are introduced into corn and used as pollinators to enhance oil content in commercially produced grain and an embodiment where the blends include a male-sterile grain parent, a male-fertile pollinator isogenic to the grain parent, and a high oil, rapidly fermentable starch pollinator to mitigate the risk of crop failure under high stress environments (paragraphs [00128-00129]).
Before the time of filing of the instant application, it would have been obvious to combine the method of Lanahan, Cope, and Della Porta of pollinating a hybrid maize plant with a transgenic plant comprising a gene expressing α-amylase with the method of Meis comprising providing a blend of both an isogenic pollen donator and a rapidly fermentable starch pollen donator. One of ordinary skill in the art would have been motivated to provide pollen from two different pollen donators to mitigate the risk of crop failure under high stress environments and protect yield. One of ordinary skill in the art would have had reasonable expectation of success, because the maize crosses in both Lanahan and Meis improve starch characteristics and improve fermentation.
Notably, the crosses of Lanahan and Meis comprising a blend of pollen donors including an isogenic pollen donor and a rapidly fermentable starch pollen donor would result in the harvest of a grain lot comprising both harvested grain that comprised the genetically modified locus as well as harvested grain that did not comprise the genetically modified locus. Claims 12 and 17 are product by process claims. A mixed grain lot comprising grain both with and without a genetically modified locus is encompassed by instant claim 12 as long as at least some of the grain in the lot was obtained by the method of instant claim 1. Thus, the grain lot of claim 12 encompasses even grain lots comprising grain harvested by the method of instant claim 1 mixed with grain harvested by another method of crossing. Claims 13, 14 & 16 may also encompass grain lots comprising grain that comprises the genetically modified locus as well as harvested grain that does not comprise the genetically modified locus.
Because a grain lot harvested from the method of Lanahan and Meis comprises some individual grains without a genetically modified locus, a single grain that does not comprise a genetically modified locus would be encompassed by instant claim 17 (a single grain of the grain lot of claim 12). A grain resulting from the claimed method of crossing that does not comprise a genetically modified locus would not comprise any markedly different characteristics from any other grain produced by any other method of crossing the pollen recipient plant with an isogenic pollen donator, because the improved grain trait of instant claim 1 is conferred by the genetically modified locus. Thus, the single grain without the genetically modified locus would not comprise any biological or phenotypic properties not found in another grain of the same genetic background. See MPEP 2106.04(c)(II).
Thus, Lanahan, Cope, Della Porta and Meis make obvious claims 1-3, 5-10, 12-14 & 16-17.
Applicant urges that claim 1 recites a method wherein the pollen formulation is obtained from a pollen donor source produced at a site separate from the field where the pollen recipient plant is grown, and neither Lanahan nor Meis teach or suggest this limitation. Applicant urges that Meis relies on open pollination between plants grown together in the same field, which is fundamentally different from the claimed method (Remarks, page 10, paragraph 3-page 11, paragraph 1).
This argument is unpersuasive, because the teaching of Meis in isolation does not render the invention non-obvious over the combination of references. Cope teaches a motivation to plant a corn female receiver for pollen and later place an order for pollen that will confer traits for the desired market. Cope also teaches an embodiment wherein pollen is obtained from multiple genetic sources and combined prior to application (Cope claim 20), which also reads on a blend of pollen donor sources. Della Porta teaches that the guidelines for isolation of genetically modified maize requires 1600m for fields planted at the same time or 800 m for fields planted with a 4-week time-shift. Thus, one of ordinary skill in the art would have been motivated based on the teachings of Cope and Della Porta to grow pollen recipient plants in a field at least 800m from genetically modified maize, such as a pollen donor source comprising a genetically modified locus, and order pollen from a donor bank for pollination. This reads on the limitation of obtaining pollen from a pollen donor source produced at a site separate from the field where the pollen recipient plant is grown. One of ordinary skill in the art would have been motivated to perform this method on plants comprising a transgene affecting starch fermentability based on the teachings of Meis.
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, 5-10, 12-14 & 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 & 11-15 of copending Application No. 18/722,451 (reference application, hereafter ‘451). Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a method 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 trait as well as a grain lot comprising harvested grain comprising a maize pollen recipient plant genome and a paternal genome comprising at least one genetically modified locus which confers an improved trait.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 10/30/2025 as applied to claims 1-3, 5-10, 12-14 & 16-17. Applicant' s arguments filed 1/26/2026 have been fully considered but they are not persuasive.
Although the instant claims require an improved grain feed trait and the reference claims require an improved grain fuel trait, both claim sets encompass methods and grain lots wherein the improved trait is amylase content (instant claims 2-3, 14 & 16 vs ‘451 claims 2-3 & 13-14). Furthermore, ‘451 claims 3 & 14 require a genetically modified locus encoding an amylase gene comprising ‘451 SEQ ID NO: 2, which has 100% sequence identity to instant SEQ ID NO: 2, required by instant claims 3 & 16. See alignment below. Additional limitations of the claims beyond the required grain traits are identical.
Range 1: 1 to 436GraphicsNext MatchPrevious Match
Alignment statistics for match #1
Score
Expect
Method
Identities
Positives
Gaps
883 bits(2282)
0.0
Compositional matrix adjust.
436/436(100%)
436/436(100%)
0/436(0%)
Query 1 MAKYLELEEGGVIMQAFYWDVPSGGIWWDTIRQKIPEWYDAGISAIWIPPASKGMSGGYS 60
MAKYLELEEGGVIMQAFYWDVPSGGIWWDTIRQKIPEWYDAGISAIWIPPASKGMSGGYS
Sbjct 1 MAKYLELEEGGVIMQAFYWDVPSGGIWWDTIRQKIPEWYDAGISAIWIPPASKGMSGGYS 60
Query 61 MGYDPYDYFDLGEYYQKGTVETRFGSKQELINMINTAHAYGIKVIADIVINHRAGGDLEW 120
MGYDPYDYFDLGEYYQKGTVETRFGSKQELINMINTAHAYGIKVIADIVINHRAGGDLEW
Sbjct 61 MGYDPYDYFDLGEYYQKGTVETRFGSKQELINMINTAHAYGIKVIADIVINHRAGGDLEW 120
Query 121 NPFVGDYTWTDFSKVASGKYTANYLDFHPNELHAGDSGTFGGYPDICHDKSWDQYWLWAS 180
NPFVGDYTWTDFSKVASGKYTANYLDFHPNELHAGDSGTFGGYPDICHDKSWDQYWLWAS
Sbjct 121 NPFVGDYTWTDFSKVASGKYTANYLDFHPNELHAGDSGTFGGYPDICHDKSWDQYWLWAS 180
Query 181 QESYAAYLRSIGIDAWRFDYVKGYGAWVVKDWLNWWGGWAVGEYWDTNVDALLNWAYSSG 240
QESYAAYLRSIGIDAWRFDYVKGYGAWVVKDWLNWWGGWAVGEYWDTNVDALLNWAYSSG
Sbjct 181 QESYAAYLRSIGIDAWRFDYVKGYGAWVVKDWLNWWGGWAVGEYWDTNVDALLNWAYSSG 240
Query 241 AKVFDFPLYYKMDAAFDNKNIPALVEALKNGGTVVSRDPFKAVTFVANHDTDIIWNKYPA 300
AKVFDFPLYYKMDAAFDNKNIPALVEALKNGGTVVSRDPFKAVTFVANHDTDIIWNKYPA
Sbjct 241 AKVFDFPLYYKMDAAFDNKNIPALVEALKNGGTVVSRDPFKAVTFVANHDTDIIWNKYPA 300
Query 301 YAFILTYEGQPTIFYRDYEEWLNKDKLKNLIWIHDNLAGGSTSIVYYDSDEMIFVRNGYG 360
YAFILTYEGQPTIFYRDYEEWLNKDKLKNLIWIHDNLAGGSTSIVYYDSDEMIFVRNGYG
Sbjct 301 YAFILTYEGQPTIFYRDYEEWLNKDKLKNLIWIHDNLAGGSTSIVYYDSDEMIFVRNGYG 360
Query 361 SKPGLITYINLGSSKVGRWVYVPKFAGACIHEYTGNLGGWVDKYVYSSGWVYLEAPAYDP 420
SKPGLITYINLGSSKVGRWVYVPKFAGACIHEYTGNLGGWVDKYVYSSGWVYLEAPAYDP
Sbjct 361 SKPGLITYINLGSSKVGRWVYVPKFAGACIHEYTGNLGGWVDKYVYSSGWVYLEAPAYDP 420
Query 421 ANGQYGYSVWSYCGVG 436
ANGQYGYSVWSYCGVG
Sbjct 421 ANGQYGYSVWSYCGVG 436
Given the short list of improved grain traits and sequences in ‘451 claims 2 & 3, which encompasses the elected species of amylase content and instant SEQ ID NO: 2, one of ordinary skill in the art can immediately envisage the claimed species of instant claims 1-3, 5-10, 12-14 & 16-17 from ‘451 claims 2-9 & 11-15. Additionally, ‘451 claim 5 recites the pollen donor located more than at least 200, 400, 600, 800, or 1,000 meters from the pollen recipient, which reads on the pollen donor source produced at a site separate from the field where the recipient plant is grown. The limitations of amended instant claim 1 would be obvious in view of ‘451 claim 5. Cross mapping of individual instant claims to individual reference claims is provided below. Thus, instant claims 1-3, 5-10, 12-14 & 16-17 are anticipated by ‘451 claims 2-9 & 11-15.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant Claim/Reference Claim
1 2 in view of claim 5
2 2
3 3
5 4
6 5
7 6
8 7
9 8
10 9
12 11
13 12
14 13
16 14
17 15
Applicant urges that the instant claims are patentably distinct from the co-pending claims of Application 18/722,451 because the instant claims are directed to improved grain feed traits while the claims of ‘451 are directed to grain fuel traits. Applicant urges that this represents distinct applications and markets for the claimed grain products (Remarks page 13, paragraph 3).
This argument is unpersuasive, because a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the reference claims in order to patentably distinguish the claimed invention. If the structure of the referenced claims is capable of performing the intended use, then it meets the claim.
Applicant urges that the instant claims are patentably distinct from the co-pending claims of Application 18/722,451 because the instant claims recite “wherein the pollen formulation is obtained from a pollen donor source produced at a site separate from the field where the pollen recipient plant is grown” which is not required by the claims of ‘451 (Remarks page 13, paragraph 3).
This argument is unpersuasive, because ‘451 claim 5 recites the limitation of the pollen donor located at various distances from the pollen recipient, which reads on a pollen donor source produced at a site separate from the field where the pollen recipient plant is grown and makes obvious the instant claims.
Applicant requests that the provisional non-statutory double patenting rejections be held in abeyance until allowable subject matter is identified (Remarks, page 13, paragraph 5-page 14, paragraph 1).
This argument is unpersuasive, because only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. See MPEP § 804(I)(B)(1).
Claims 12-14, & 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44-46 & 48, of copending Application No. 18/724,749 (reference application, hereafter ‘749). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘749 claim 44 is drawn to a method of producing maize grain comprising contacting a maize pollen recipient plant with maize pollen or formulation of a transgenic maize plant, comprising an INOT1824 transgenic locus comprising the amy797E coding region, and harvesting grain comprising the INOT1824 transgenic locus from the pollen recipient plant, wherein the pollen recipient plant optionally lacks an INOT1824 transgenic locus.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 10/30/2025 as applied to claims 1-3, 7, 8, 10, 12-14, & 17. Applicant' s arguments filed 1/26/2026 have been fully considered but they are not persuasive.
The INOT1824 locus comprises a sequence that encodes an amino acid sequence with 100% sequence identity to instant SEQ ID NO: 2. See alignment of instant SEQ ID NO: 2 (top) with translated ‘749 SEQ ID NO: 8 (bottom).
Range 1: 2355 to 3659GraphicsNext MatchPrevious Match
Alignment statistics for match #1
Score
Expect
Method
Identities
Positives
Gaps
Frame
849 bits(2194)
0.0
Compositional matrix adjust.
435/435(100%)
435/435(100%)
0/435(0%)
+3
Query 2 AKYLELEEGGVIMQAFYWDVPSGGIWWDTIRQKIPEWYDAGISAIWIPPASKgmsggysm 61
AKYLELEEGGVIMQAFYWDVPSGGIWWDTIRQKIPEWYDAGISAIWIPPASKGMSGGYSM
Sbjct 2355 AKYLELEEGGVIMQAFYWDVPSGGIWWDTIRQKIPEWYDAGISAIWIPPASKGMSGGYSM 2534
Query 62 gydpydyFDLGEYYQKGTVETRFGSKQELINMINTAHAYGIKVIADIVINHRAGGDLEWN 121
GYDPYDYFDLGEYYQKGTVETRFGSKQELINMINTAHAYGIKVIADIVINHRAGGDLEWN
Sbjct 2535 GYDPYDYFDLGEYYQKGTVETRFGSKQELINMINTAHAYGIKVIADIVINHRAGGDLEWN 2714
Query 122 PFVGDYTWTDFSKVASGKYTANYLDFHPNELHAGDSGTFGGYPDICHDKSWDQYWLWASQ 181
PFVGDYTWTDFSKVASGKYTANYLDFHPNELHAGDSGTFGGYPDICHDKSWDQYWLWASQ
Sbjct 2715 PFVGDYTWTDFSKVASGKYTANYLDFHPNELHAGDSGTFGGYPDICHDKSWDQYWLWASQ 2894
Query 182 ESYAAYLRSIGIDAWRFDYVKGYGAWVVKDWLNWWGGWAVGEYWDTNVDALLNWAYSSGA 241
ESYAAYLRSIGIDAWRFDYVKGYGAWVVKDWLNWWGGWAVGEYWDTNVDALLNWAYSSGA
Sbjct 2895 ESYAAYLRSIGIDAWRFDYVKGYGAWVVKDWLNWWGGWAVGEYWDTNVDALLNWAYSSGA 3074
Query 242 KVFDFPLYYKMDAAFDNKNIPALVEALKNGGTVVSRDPFKAVTFVANHDTDIIWNKYPAY 301
KVFDFPLYYKMDAAFDNKNIPALVEALKNGGTVVSRDPFKAVTFVANHDTDIIWNKYPAY
Sbjct 3075 KVFDFPLYYKMDAAFDNKNIPALVEALKNGGTVVSRDPFKAVTFVANHDTDIIWNKYPAY 3254
Query 302 AFILTYEGQPTIFYRDYEEWLNKDKLKNLIWIHDNLAGGSTSIVYYDSDEMIFVRNGYGS 361
AFILTYEGQPTIFYRDYEEWLNKDKLKNLIWIHDNLAGGSTSIVYYDSDEMIFVRNGYGS
Sbjct 3255 AFILTYEGQPTIFYRDYEEWLNKDKLKNLIWIHDNLAGGSTSIVYYDSDEMIFVRNGYGS 3434
Query 362 KPGLITYINLGSSKVGRWVYVPKFAGACIHEYTGNLGGWVDKYVYSSGWVYLEAPAYDPA 421
KPGLITYINLGSSKVGRWVYVPKFAGACIHEYTGNLGGWVDKYVYSSGWVYLEAPAYDPA
Sbjct 3435 KPGLITYINLGSSKVGRWVYVPKFAGACIHEYTGNLGGWVDKYVYSSGWVYLEAPAYDPA 3614
Query 422 NGQYGYSVWSYCGVG 436
NGQYGYSVWSYCGVG
Sbjct 3615 NGQYGYSVWSYCGVG 3659
Instant claims 12 & 17 are product-by-process claims. The method of ‘749 claim 44 would result in a harvested grain lot comprising harvested grain wherein a pollen recipient plant is contacted with a pollen formulation comprising at least one genetically modified locus which confers an improved grain feed trait, wherein the pollen recipient plant lacks said genetically modified locus, and wherein the improved grain feed trait is amylase content and the locus encodes an amylase protein set forth in SEQ ID NO: 2. The location where the pollen donor is sourced would not impart distinguishable features on the grain lot and single grains harvested. Thus, the grain lot comprising grain produced by the method of ‘749 would be patentably indistinct from that obtained by the method of instant claim 1 (instant claim 12), a single grain of the grain lot (instant claim 17), and a grain lot comprising harvested grain comprising a pollen recipient plant genome and a paternal genome comprising at least one genetically modified locus which confers an improved grain feed trait of amylase content (instant claims 13-14 & 16). Instant claims 12-14 & 16-17 are inherently anticipated by the method of ‘749 claim 44.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant urges that the instant claims are patentably distinct from the claims of co-pending Application 18/724,749 because the instant claims recite “wherein the pollen formulation is obtained from a pollen donor source produced at a site separate from the field where the pollen recipient plant is grown” which is not required by the claims of ‘749 (Remarks, page 13, paragraph 4).
This argument is unpersuasive, because claims 12 & 17 are product-by-process claims. The method wherein the pollen formulation is obtained from a pollen donor source produced at a site separate from the field where the pollen recipient plant is grown would not impart structural, biological, or functional characteristics on the harvested grain that would make the claimed products patentably distinguishable from grain harvested by the method of ‘749.
Applicant requests that the provisional non-statutory double patenting rejections be held in abeyance until allowable subject matter is identified (Remarks, page 13, paragraph 5-page 14, paragraph 1).
This argument is unpersuasive, because only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. See MPEP § 804(I)(B)(1).
Conclusion
No claims are allowed.
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 Victoria L DeLeo whose telephone number is (703)756-5998. The examiner can normally be reached M-F 8:00am-4pm EDT.
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/VICTORIA L DELEO/Examiner, Art Unit 1662
/Anne Kubelik/Primary Examiner, Art Unit 1663
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