DETAILED ACTION
Claims 1-23 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 ¶5, 6, 11, 36, 45, 51, 56, 60, and 268.
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 (¶267-274).
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 are 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
Claim 12 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only; part (b) does not. See MPEP § 608.01(n). Accordingly, the claim has not been further treated on the merits.
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 17-20 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 17 is drawn to a method of producing a plant of hybrid CIDER comprising at least one desired trait, where the method comprises introducing a single locus conversion conferring the trait into CIDER. Claim 18 is drawn to a pumpkin plant, wherein the plant has a single locus conversion and otherwise all of the physiological and morphological characteristics of hybrid CIDER. Dependent claim 19 recites the trait conferred by the single locus conversion.
Dependent claim 20 recites that the single locus conversion is introduced into the plant by a genetic transformation or gene editing technique with a zinc finger nuclease, an engineered homing endonuclease/meganuclease, or CRISPR/Cas system.
The specification teaches that single locus conversion is introduced into the plant by recurrent selection, mutation breeding, backcrossing, pedigree breeding, haploid/double haploid production, marker-assisted selection, genomic selection, synthetic genomics, oligonucleotide directed mutagenesis, and agro-infiltration, as well as the methods in claim 20 (¶28, 56).
None of these methods will produce a plant with otherwise all of the physiological and morphological characteristics of hybrid CIDER.
CIDER is an F1 hybrid, produced by crossing inbred pumpkin plants not known in the art (¶229-232). When an inbred is crossed to itself, the progeny are all identical to itself. When an F1 like CIDER 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 CIDER to another plant, which generates progeny with segregating traits. Backcrossing those progeny plants to CIDER will not generate plants with all of the physiological and morphological characteristics of hybrid CIDER.
Because CIDER is an F1, haploid/double haploid production will also not result in plants with essentially all of the physiological and morphological characteristics of hybrid CIDER.
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 20 or taught in the specification will produce plants with all of the physiological and morphological characteristics of hybrid CIDER.
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 CIDER using any of these methods.
The only way to produce a pumpkin plant, wherein the plant has a single locus conversion and otherwise all of the physiological and morphological characteristics of hybrid CIDER is to introduce the single locus conversion into one of CIDER’s parents, for example by one of the methods in ¶132-150, 177-179, and 191-208, then cross the single-locus converted parent to the other of CIDER’s parents. This method is also not enabled by the specification because CIDER’s parents are not available, either publically or by deposit 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 CIDER.
Claims 1-11 and 13-23 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 honeydew plant 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 as seen in the specification and names for its parents. 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. 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 2 and 4-5 are drawn to a plant that has all of the physiological and morphological characteristics of hybrid pumpkin designated CIDER when grown under the same environmental condition or a tissue culture of regenerable cells produced from the plant.
Plants grown under the same environmental condition (note this is singular) encompass those where all the other environmental conditions are different. The full scope of plants that have all the physiological and morphological characteristics of CIDER when the two plants are grown in environmental conditions where only one of those conditions is the same and all other conditions are different are not described.
The structural features that distinguish pumpkin plants that fall within the claimed genus from those that do not 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.
C. Claims 18-20 are drawn to a plant that has single locus conversion and otherwise all the morphological and physiological characteristics of hybrid CIDER.
The specification indicates that plants with a single locus conversion actually encompass plants with an unlimited number of locus conversions (¶54):
[0054] In some embodiments, the present disclosure teaches plants grown from the deposited CIDER 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 CIDER.
Thus, claims 18-20 encompass plants that differ from CIDER 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 pumpkin CIDER 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 pumpkin plants that fall within the claimed genus from those that do not are not described in the specification. The structural features that distinguish pumpkin 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 1-11 and 13-23 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, 11, and 13-18 are indefinite for their recitation of “CIDER” as seeds of the plant have not been deposited and as its parents are not known in the art.
Claim 17 is indefinite for claiming a method of using CIDER without reciting a deposit for the plant.
Claim 20 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 20 lacks antecedent basis for the limitation “the clustered regularly interspaced short palindromic repeat (CRISPR)-associated protein (Cas) system” in lines 4-5.
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, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osborne Quality Seeds (2020, Cider F1 Untreated Specialty Pumpkin Seeds, https://www. osborneseed.com/collections/new-pumpkin/products/pumpkin-specialty-cider-f1-untreated).
Osborne Quality Seeds offers CIDER Pumpkin for sale. In the photos fruits and plants are visible. This plant would be identical to a pumpkin plant regenerated from a tissue from the plant where a plant regenerated from the tissue culture has all of the physiological and morphological characteristics of hybrid pumpkin designated CIDER and to a pumpkin plant that has all of the physiological and morphological characteristics of hybrid pumpkin designated CIDER.
Claim Rejections - 35 USC § 103
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.
Claims 1-11 and 13-23 are rejected under 35 U.S.C. 103(a) as being unpatentable over Osborne Quality Seeds (2020, Cider F1 Untreated Specialty Pumpkin Seeds, https://www. osborneseed.com/collections/new-pumpkin/products/pumpkin-specialty-cider-f1-untreated) in view of Superak (2020, US 10,631,493).
The claims are drawn to a seed of hybrid CIDER, 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 CIDER, the plant comprising a single locus conversion and essentially all the morphological and physiological characteristics of hybrid CIDER, methods of harvesting the fruit and producing pumpkin 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 Osborne Quality Seeds are discussed above. Osborne Quality Seeds does not teach tissue culture of CIDER, a method comprising growing CIDER and harvesting fruit, a method comprising crossing CIDER with another melon plant, harvesting the resulting seed or plant, crossing that plant with itself or another plant for several generations to produce a pumpkin plant derived from CIDER, a method comprising selfing CIDER and harvesting the resulting seed, a method comprising regenerating a plant from a part of CIDER and harvesting a fruit from said regenerated plant, a method comprising backcrossing a single locus conversion from another plant into CIDER and plants thereby produced, grafting a rootstock or a scion of CIDER to another pumpkin plant, or a method comprising isolating nucleic acids from CIDER.
Superak teaches a pumpkin plant (Table 1), tissue culture of the plant and that it can be used in a method of vegetative propagation (column 10 lines 41-54; column 35, lines 27-62), regenerating a plant from the tissue culture or plant part (column 9, lines 30-51; column 28, lines 2-13; column 35, lines 27-62), growing the plant and harvesting fruit (column 3, lines 36-47; column 10, lines 39-49), a method comprising crossing the plant with another pumpkin plant or selfing it, harvesting the resulting seed or plant, crossing that plant with itself or another plant for several generations to produce a pumpkin plant derived from the plant (column 11, lines 36-53), methods involving isolating nucleic acids from the plant in breeding analysis (column 30, line 212, to column 32, line 16), a method of backcrossing a single locus conversion into the plant, including where the single locus conversion confers disease or insect resistance (column 20, line 18, to column 22, line 2), and grafting a rootstock or a scion of the plant to another pumpkin plant to confer disease resistance to the plant (column 13, lines 38-46; column 15, lines 44-45; column 28, lines 13-30).
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 CIDER. One of ordinary skill in the art would have been motivated to do so to take advantage of the benefits these methods confer.
One of ordinary skill in the art would have produced a tissue culture of CIDER because tissue cultures can be used for vegetative propagation of the plant (Superak, 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 CIDER, using the methods taught by Superak (column 20, line 18, to column 22, line 2) to increase the insect and/or disease resistance of the plant , allowing it to be grown in areas with insect pest and/or disease prevalence.
One of ordinary skill in the art would have grown CIDER and harvested fruit because the fruit is what farmers sell to consumers.
One of ordinary skill in the art would have crossed CIDER with another pumpkin plant or itself, harvested the resulting seed or plant, and crossed that plant with itself or another plant for several generations to produce a pumpkin plant derived from CIDER to confer CIDER’s traits like powdery mildew resistance (Osborne Quality Seeds, see attributes) on other pumpkin plants.
One of ordinary skill in the art would have regenerated a plant from a part of CIDER and harvested a fruit from said regenerated plant because vegetative propagation is a method generating more CIDER plants and obtaining fruit for sale.
One of ordinary skill in the art would have grafted a scion of CIDER to another pumpkin plant to take advantage of its disease resistance.
One of ordinary skill in the art would have isolated nucleic acids from CIDER to determine if another plant is related or identical to it.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo (Joe) Zhou, can be reached at (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/Anne Kubelik/Primary Examiner, Art Unit 1662