DETAILED ACTION
Claims 1-25 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The specification is objected to for blank lines in ¶7, 8, 13, 37, 43, 46, 47, 52, 57, 58, and 294.
Deposit of Biological Material
This application requires public availability of specific biological material to make and use the claimed invention. A rejection under the appropriate sections of 35 USC 112 would have been made but for Applicant’s statement indicating that an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809 will be made with a recognized IDA, at or before the payment of the issue fee, in the event that the application should be determined to be allowable (¶293-300).
Because viability testing of all deposits is required before they can be considered to meet the requirements of 37 CFR 1.801-1.809, Applicants is advised to perfect the deposit as early as is possible, and before the payment of the issue fee. Failure to perfect a deposit by the date of payment of the issue fee may result in abandonment of the application for failure to prosecute.
Claim Objections
Applicant is advised that should claim 6 be found allowable, claims 8 and 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Similarly, Applicant is advised that should claim 2 be found allowable, claims 5 and 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 19 is drawn to a method of producing a plant of hybrid AIRLIE comprising at least one desired trait, where the method comprises introducing a single locus conversion conferring the trait into AIRLIE. Claim 20 is drawn to a sweet corn plant, wherein the plant has a single locus conversion and otherwise all of the physiological and morphological characteristics of hybrid AIRLIE. Dependent claim 21 recites the trait conferred by the single locus conversion.
Dependent claim 22 recites that the single locus conversion is introduced into the plant by recurrent selection, mutation breeding, wherein said mutation breeding selects for a mutation that is spontaneous or artificially induced, backcrossing, pedigree breeding, haploid/double haploid production, marker-assisted selection, genetic transformation, genomic selection, Zinc finger nuclease (ZFN), oligonucleotide directed mutagenesis, cisgenesis, intragenesis, RNA-dependent DNA methylation, agro-infiltration, Transcription Activation-Like Effector Nuclease (TALENs), CRISPR/Cas system, engineered meganuclease, engineered homing endonuclease, and/or DNA guided genome editing.
None of these methods will produce a plant with otherwise all or “essentially all” of the physiological and morphological characteristics of hybrid AIRLIE.
AIRLIE is an F1 hybrid, produced by crossing inbred sweet corn plants not known in the art (¶280-283). When an inbred is crossed to itself, the progeny are all identical to the inbred. When an F1 hybrid like AIRLIE is crossed to itself, the progeny are all diverse, with each trait that is heterozygous in the F1 segregating in the resulting progeny. No amount of continued selfing will regenerate the F1 or a plant with all of the physiological and morphological characteristics of hybrid.
Methods like recurrent selection, mutation breeding, backcrossing, pedigree breeding, haploid/double haploid production, marker-assisted selection, and genomic selection (e.g., ¶151-162, 189-190) all require crossing AIRLIE to another plant, which generates progeny with segregating traits. Backcrossing those progeny plants to AIRLIE will not generate plants with all of the physiological and morphological characteristics of hybrid AIRLIE.
Because AIRLIE is an F1, haploid/double haploid production will also not result in plants with essentially all of the physiological and morphological characteristics of hybrid AIRLIE.
Agro-infiltration is used for transient expression of a gene (¶100) and thus will not produce a single locus conversion, which requires genomic modification.
Transformation, synthetic genomics cisgenesis, intragenesis, RNA-dependent DNA methylation, and gene editing techniques, including those using a zinc finger nuclease, an engineered homing endonuclease/meganuclease, or CRISPR/Cas system, require backcrossing to eliminate off-target alterations. Similarly, oligonucleotide directed mutagenesis, cisgenesis, intragenesis, and RNA-dependent DNA methylation require backcrossing to eliminate off-target alterations. Thus, none of the methodologies claimed in claim 22 or taught in the specification will produce plants with all of the physiological and morphological characteristics of hybrid AIRLIE.
The specification fails to overcome this unpredictability by providing a working example of production of a plant that has a single locus conversion and all of the physiological and morphological characteristics of hybrid AIRLIE using these methods.
The only way to produce the sweet corn plant claimed in claims 20-22, wherein the plant has a single locus conversion and otherwise all of the physiological and morphological characteristics of hybrid AIRLIE, is to introduce the single locus conversion into one of AIRLIE’s parents, for example by one of the methods in claim 22, then to cross the single-locus converted parent to the other AIRLIE parent. However, this method is also not enabled by the specification because AIRLIE’s parents are not available, either publically or by deposit under the requirements of 37 CFR 1.801-1.809.
Claims 20-22 can be enabled by deposit of AIRLIE’s parents under the requirements of 37 CFR 1.801-1.809.
Given the claim breath, unpredictability, and lack of guidance as discussed above, undue experimentation would have been required by one skilled in the art to develop and evaluate these methods for producing a plant that has a single locus conversion and essentially all of the physiological and morphological characteristics of hybrid AIRLIE.
Claims 1-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
A. The instant specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an to conduct a complete examination, including search of the prior art. MPEP 2163 (I) states
The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").
The instant specification fails to satisfy the written description because it does not provide enough description to be sufficient to aid in the resolution of questions of infringement. MPEP 2163(I) states
“The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
In the instant application, a full examination cannot be conducted. Applicant is claiming a new hybrid sweet corn variety. A plant variety is defined by both its genetics (breeding history) and its traits. In the instant application, Applicant has provided a description of the plant traits (Table 1) and names for its parents (¶280). However, the parents are not known in the art, at least by the names provided. The instant application is thus incomplete as to the breeding history used to produce the claimed plant variety.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (USDA, “Applying for a Plant Variety Certificate of Protection”, https://www.ams.usda.gov/services/pvpo/application-help/apply, accessed 1 May 2023). Additionally, the International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV, 2017, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, see notes 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen, Board Decision in Application 14/996,093, 2020). In both of these cases, there were many differences cited by the applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
Moreover, a specification devoid of a breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotype of the claimed plant for assessing potential infringement.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. The assumption that elite cultivars are composed of relatively homogenous genetic pools is false (Haun et al, 2011, Plant Physiol. 155:645-655; see pg 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (pg 645, right column, paragraph 2, to pg 646, left column, paragraph 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al, 2015, J. Exp. Bot. 66:5429-5440; see pg 5430 left column, paragraph 2, and right column, paragraph 2). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification to provide all names of the parents used to develop the instant variety or cultivar. If Applicant’s breeding history uses proprietary line names, Applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information, or state in the response that the parents have no other names. If either of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line(s) as well (i.e., grandparents), including all names of the plants used to produce that parent.
Applicant is also reminded of the duty to disclose information material to patentability. Applicant should also note the most similar plants, which should include any other plants created using similar breeding history (such as siblings of the instant variety). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
B. Claims 20-22 are drawn to a plant that has single locus conversion and essentially all the morphological and physiological characteristics of hybrid AIRLIE.
The specification does not define “essentially all of the characteristics” but does define “essentially all of the physiological and morphological characteristics”:
[0076] Essentially all of the physiological and morphological characteristics: A plant having essentially all the physiological and morphological characteristics means a plant having all of the physiological and morphological characteristics of a plant of the present disclosure, except for additional traits and/or mutations which do not materially affect the plant of the present disclosure, or desired characteristic(s), which can be indirectly obtained from another plant possessing at least one single locus conversion via a conventional breeding program (such as backcross breeding) or directly obtained by introduction of at least one single locus conversion via New Breeding Techniques. In some embodiments, one of the non-limiting examples for a plant having (and/or comprising) essentially all of the physiological and morphological characteristics shall be a plant having all of the physiological and morphological characteristics of a plant of the present disclosure other than desired, additional trait(s)/characteristic(s) conferred by a single locus conversion including, but not limited to, a converted or modified gene.
The specification indicates that plants with a single locus conversion actually encompass plants with an unlimited number of locus conversions (¶55):
[0055] In some embodiments, the present disclosure teaches plants grown from the deposited AIRLIE seed wherein said plants comprise a single locus conversion. As used herein, the term "a" or "an" refers to one or more of that entity; for example, "a single locus conversion" refers to one or more single locus conversions or at least one single locus conversion. As such, the terms "a" (or "an"),"one or more" and "at least one" are used interchangeably herein. In addition, reference to "an element" by the indefinite article "a" or "an" does not exclude the possibility that more than one of the elements are present, unless the context clearly requires that there is one and only one of the elements.
The claims do not require that the plants have one and only one single locus conversion and otherwise all the morphological and physiological characteristics of hybrid AIRLIE.
The specification describes no additional traits and/or mutations that “do not materially affect the plant”.
Thus, claims 20-22 encompass plants that differ from AIRLIE by an unlimited number of single locus conversions and in an unlimited number of traits.
The only plant described in the specification within the scope of the claims is hybrid sweet corn AIRLIE itself. One of skill in the art would not recognize that Applicant was in possession of the necessary common traits or features of the claimed very large genus in view of the single disclosed species.
The structural features that distinguish sweet corn plants that fall within the claimed genus from those that do not are not described in the specification. The structural features that distinguish sweet corn plants that fall within the claimed genus from those that are one morphological and physiological characteristic outside that genus are not described in the specification.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed plants, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
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 the second paragraph of 35 U.S.C. 112:
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 1-25 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claims 1-2, 4-5, 13, and 16-20 are indefinite for their recitation of “AIRLIE” as seeds of the plant have not been deposited and as its parents are not known in the art.
Claim 19 is indefinite for claiming a method of using AIRLIE without reciting a deposit for the plant.
Claim 20 is indefinite for its recitation of “and essentially all of the characteristics of hybrid sweet corn designated AIRLIE”. The specification does not define “essentially all of the characteristics” but does define “essentially all of the physiological and morphological characteristics”:
[0076] Essentially all of the physiological and morphological characteristics: A plant having essentially all the physiological and morphological characteristics means a plant having all of the physiological and morphological characteristics of a plant of the present disclosure, except for additional traits and/or mutations which do not materially affect the plant of the present disclosure, or desired characteristic(s), which can be indirectly obtained from another plant possessing at least one single locus conversion via a conventional breeding program (such as backcross breeding) or directly obtained by introduction of at least one single locus conversion via New Breeding Techniques. In some embodiments, one of the non-limiting examples for a plant having (and/or comprising) essentially all of the physiological and morphological characteristics shall be a plant having all of the physiological and morphological characteristics of a plant of the present disclosure other than desired, additional trait(s)/characteristic(s) conferred by a single locus conversion including, but not limited to, a converted or modified gene.
It is not clear what additional traits and/or mutations do not materially affect the plant or what an additional trait or mutations does not materially affect the plant might be. The metes and bounds of the claim are unclear.
Claim 22 is indefinite in claiming both a plant and a method of making it. When a claim mixes statutory classes, it is unclear when direct infringement occurs. See MPEP 2173.05(p) II. It is suggested that “is” in line 1 be replaced with --was--.
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)(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.
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 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.
Claims 1-3, 5-6, 8 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HM Clause (2020, AIRLIE (HMC590308), https://ampa.hmclausefielddays.com/ products/corn/sh2-yellow/hmc590308).
HM Clause reveals AIRLIE sweet corn to the public, and public is invited to request more information about it; thus, even though the video states that all HMX varieties are not available to the public, that does not appear to apply to AIRLIE. The text mentions plants, and an ear is visible in the photo; the ear comprises seeds, also visible in the photo. This plant would be identical to a sweet corn plant regenerated from a tissue from the plant or by vegetative propagation, where a plant regenerated from the tissue culture or by vegetative propagation has all of the physiological and morphological characteristics of hybrid sweet corn designated AIRLIE and to a sweet corn plant that has all of the physiological and morphological characteristics of hybrid sweet corn designated AIRLIE.
Claim Rejections - 35 USC § 103
The 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.
Claims 1-25 are rejected under 35 U.S.C. 103(a) as being unpatentable over HM Clause (2020, AIRLIE (HMC590308), https://ampa.hmclausefielddays.com/products/corn/sh2-yellow/hmc590308) in view of Snyder (2022, US 11,252,891).
The claims are drawn to a seed of hybrid AIRLIE, a plant part, a tissue culture or a plant cell, where a plant regenerated from the plant part, tissue culture, or plant cell has all the morphological and physiological characteristics of hybrid AIRLIE, the plant comprising a single locus conversion and essentially all the morphological and physiological characteristics of hybrid AIRLIE, methods of harvesting the ears and producing sweet corn seed, methods of vegetatively propagating and grafting the plant, methods comprising applying plant breeding techniques to the plant, and methods comprising isolating nucleic acids from the plant.
The teachings of HM Clause are discussed above. HM Clause does not teach tissue culture of AIRLIE, a method comprising growing AIRLIE and harvesting ears, a method comprising crossing AIRLIE with another melon plant, harvesting the resulting seed or plant, crossing that plant with itself or another plant for several generations to produce a sweet corn plant derived from AIRLIE, a method comprising selfing AIRLIE and harvesting the resulting seed, a method comprising regenerating a plant from a part of AIRLIE and harvesting ears from said regenerated plant, a method comprising introducing a single locus conversion from another plant into AIRLIE and plants thereby produced, grafting a rootstock or a scion of AIRLIE to another sweet corn plant, or a method comprising isolating nucleic acids from AIRLIE.
Snyder teaches a sweet corn plant (Table 1), tissue culture of the plant and that it can be used in a method of vegetative propagation, and that an ear can be harvested from the propagated plant (claims 4 and 11-14), regenerating a plant from the tissue culture or plant part (claim 5-6), growing the plant and harvesting ears (claims 7-8), a method comprising crossing the plant with another sweet corn plant or selfing it, harvesting the resulting seed or plant, crossing that plant with itself or another plant for several generations to produce a sweet corn plant derived from the plant (claims 9-10 and 15-18), methods comprising isolating nucleic acids from the plant (claim 24), a method of introducing a single locus conversion into the plant, including by the use of recurrent selection, mutation breeding, wherein said mutation breeding selects for a mutation that is spontaneous or artificially induced, backcrossing, pedigree breeding, haploid/double haploid production, marker-assisted selection, genetic transformation, genomic selection, synthetic genomics, Zinc finger nuclease (ZFN), oligonucleotide directed mutagenesis, cisgenesis, intragenesis, RNA-dependent DNA methylation, agro-infiltration, Transcription Activation-Like Effector Nuclease (TALEN), CRISPR/Cas system, engineered meganuclease, engineered homing endonuclease, and/or DNA guided genome editing (claims 19 and 22), a plant thereby produced, including where the single locus conversion confers herbicide resistance (claims 20-22), grafting a rootstock or a scion of the plant to another sweet corn plant (claim 23), and a method comprising applying plant breeding techniques to the plant (claim 25).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply these methods to AIRLIE. One of ordinary skill in the art would have been motivated to do so to take advantage of the benefits these methods confer. Examples of these are listed below:
One of ordinary skill in the art would have produced a tissue culture of AIRLIE because tissue cultures can be used for vegetative propagation of the plant (Snyder, column 10 lines 41-54; column 35, lines 27-62).
One of ordinary skill in the art would have backcrossed a single locus conversion into AIRLIE, using the methods taught by Snyder to increase the herbicide resistance of the plant , allowing it to be grown in accordance to weed control practices.
One of ordinary skill in the art would have grown AIRLIE and harvested ears because the ears are what farmers sell to consumers.
One of ordinary skill in the art would have crossed AIRLIE with another sweet corn plant or itself, harvested the resulting seed or plant, and crossed that plant with itself or another plant for several generations to produce a sweet corn plant derived from AIRLIE to confer AIRLIE’s traits like reliability (HM Clause, see Features) to other sweet corn plants.
One of ordinary skill in the art would have regenerated a plant from a part of AIRLIE and harvested a ears from said regenerated plant because vegetative propagation is a method generating more AIRLIE plants and obtaining ears for sale.
One of ordinary skill in the art would have grafted a scion of AIRLIE to another sweet corn plant to take advantage of its features.
One of ordinary skill in the art would have isolated nucleic acids from AIRLIE to determine if another plant is related or identical to it.
Claim Rejections - 35 USC §§ 102, 103
The quotations of 35 U.S.C. 103 and the appropriate paragraph of 35 U.S.C. 102 appear above.
Claims 1-25 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Moran et al (2018, US 9,918,443) taken with the evidence of each of Popi (2009, US 7,473,826), Page (2016, US 9,313,970), Popi (2011, US 7,872,183), Page (2011, US 8,035,006), Popi (2012, US 8,324,476), Johnson (2007, US 7,211,717), and Page (2015, US 8,969,677).
The analysis of the prior art was made using characteristics that do not vary under different environmental conditions in an analysis of three corn varieties. Appendix A compares the descriptions of 1351729 in US 7,473,826 and US 9,313,970, of 94INK1A in US 7,872,183, US 8,035,006 and US 8,324,476, and of 1285291 in US 7,211,717 and US 8,969,677. The characteristics in bold are those that differ in the descriptions of at least one corn variety; these characteristics are those that are affected by the environmental conditions under which a plant is grown. The characteristics not in bold are those upon which this determination was made; these are brace root coloration, internode direction (degree of zig-zag), anther color, presence of a glume band (bar glumes), ear shape, husk bract length (husk extension), fresh and dry husk colors, endosperm type, and endosperm color and only discusses husk extension as a single numerical value instead as a range. The instant specification is silent about fresh and dry husk colors and endosperm color in AIRLIE.
Moran et al disclose hybrid sweet corn plant HMX4370BS, which appears to be indistinguishable from AIRLIE. Like AIRLIE, HMX4370BS has a slight degree of zigzag, yellow anthers, conical cylindrical ears, and the sh2 allele and lacks brace root coloration and bar glumes.
Thus, HMX4370BS appears to be AIRLIE. If HMX4370BS is not AIRLIE, then it is a plant with essentially all of the characteristics of AIRLIE.
Claims 1-3, 5, 8-12, and 13-16 of ‘443 are identical to instant claims 14, 6-10, and 15-16, respectively, except for the name of the variety. Claim 7 of ‘443 is identical to instant claims 5 and 13, except for the name of the variety. Claims 22-23 are species of instant claims 20-22, except for the name of the variety. Claims 13 and 15 of ‘443 are species of instant claim 25, except for the name of the variety.
A plant produced by regeneration makes obvious a method of producing the plant by regeneration; thus ‘443’s claim 7 makes obvious instant claim 11. It would be obvious to one of skill in in the art to harvest an ear from the regenerated plant, as the ear is the most economically important part of a sweet corn plant.
It would be obvious to one of skill in in the art to produce nucleic acids from the plant, as nucleic acid isolation is commonly used as part of the selection process of plant breeding via marker-assisted breeding.
It would be obvious to one of skill in in the art to graft the plant to the rootstock of another plant to take advantage of disease resistances conferred by that rootstock.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
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 1-25 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-24 of prior U.S. Patent No. 9,918,443 or, in the alternative, on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 9,918,443, taken with the evidence of each of Popi (2009, US 7,473,826), Page (2016, US 9,313,970), Popi (2011, US 7,872,183), Page (2011, US 8,035,006), Popi (2012, US 8,324,476), Johnson (2007, US 7,211,717), and Page (2015, US 8,969,677).
The analysis of the prior art was made using characteristics that do not vary under different environmental conditions in an analysis of three corn varieties. Appendix A compares the descriptions of 1351729 in US 7,473,826 and US 9,313,970, of 94INK1A in US 7,872,183, US 8,035,006 and US 8,324,476, and of 1285291 in US 7,211,717 and US 8,969,677. The characteristics in bold are those that differ in the descriptions of at least one corn variety; these characteristics are those that are affected by the environmental conditions under which a plant is grown. The characteristics not in bold are those upon which this determination was made; these are brace root coloration, internode direction (degree of zig-zag), anther color, presence of a glume band (bar glumes), ear shape, husk bract length (husk extension), fresh and dry husk colors, endosperm type, and endosperm color and only discusses husk extension as a single numerical value instead as a range. The instant specification is silent about fresh and dry husk colors and endosperm color in AIRLIE.
Moran et al claims hybrid sweet corn plant HMX4370BS, which appears to be indistinguishable from AIRLIE. Like AIRLIE, HMX4370BS has a slight degree of zigzag, yellow anthers, conical cylindrical ears, and the sh2 allele and lacks brace root coloration and bar glumes.
Thus, HMX4370BS appears to be AIRLIE. If HMX4370BS is not AIRLIE, then it is a plant with essentially all of the characteristics of AIRLIE.
Claims 1-3, 5, 8-12, and 13-16 of ‘443 are identical to instant claims 14, 6-10, and 15-16, respectively, except for the name of the variety. Claim 7 of ‘443 is identical to instant claims 5 and 13, except for the name of the variety. Claims 22-23 are species of instant claims 20-22, except for the name of the variety. Claims 13 and 15 of ‘443 are species of instant claim 25, except for the name of the variety.
A plant produced by regeneration makes obvious a method of producing the plant by regeneration; thus ‘443’s claim 7 makes obvious instant claim 11. It would be obvious to one of skill in in the art to harvest an ear from the regenerated plant, as the ear is the most economically important part of a sweet corn plant.
It would be obvious to one of skill in in the art to produce nucleic acids from the plant, as nucleic acid isolation is commonly used as part of the selection process of plant breeding via marker-assisted breeding.
It would be obvious to one of skill in in the art to graft the plant to the rootstock of another plant to take advantage of disease resistances conferred by that rootstock.
Conclusion
No claim is allowed.
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/Anne Kubelik/Primary Examiner, Art Unit 1662