DETAILED ACTION
Claims 1-29 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 .
Claim Objections
Claims 5, 8-9 and 27 are objected to because of the following informalities:
In claim 5, line 1, either --the method-- or --said method-- should be inserted after the comma for grammatical correctness.
In claims 8 and 27 “agrobacterium” should be capitalized and --from the group consisting of-- should be inserted before it.
In claim 9, line 5, “protein9” should be replaced with -- protein 9--.
Applicant is advised that should claims 8-10 be found allowable, claims 27-29, respectively, 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(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 1-29 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.
Claim 1 is indefinite in its recitation of “Cucurbita variety PUV008”, claim 11 is indefinite in its recitation of “Cucurbita plant PUV008”, and claims 8, 20, 22, and 27 are indefinite in their recitation of “PUV008” because the deposit has not been perfected.
Claims 8 and 27 are indefinite in their recitation of “said method of mutagensis is selected from … temperature, long term seed storage, somaclonal variation, radiation, chemical agents,” as none of these are methods. They are, instead, conditions or compounds.
Claims 9 and 28 lack antecedent basis for the limitation “said genetic modification” in line 1. Further, none of agrobacterium-mediated gene transfer, protoplast transformation, or biolistic transformation are genetic modifications themselves’ they are all methods of achieving genetic modification.
Claim 11 is indefinite in its recitation of “wherein said method is selected from the group comprising zinc finger nucleases, transcription activator-like effector nucleases (TALENs), engineered homing endonucleases/meganucleases, and the clustered regularly interspaced short palindromic repeat (CRISPR)-associated protein9 (Cas9) system”. The members of the list are all enzymes or systems and are not methods.
Claims 14-16 lack antecedent basis for the limitation “said plant breeding technique” as parent claim 12 recites “plant breeding techniques”.
Claims 18-19 lack antecedent basis for the limitation “the selected progeny plant” in line 1. The recitation of “selecting resulting progeny” in part (d) of parent claim 17 indicates that multiple progeny are selected - “progeny” is plural unless prefaced by “a”. Note, also, that “seed” in parts (b) and (c) of claim 17 is also plural unless prefaced by “a”.
The term “polymorphisms” in claim 26 is a relative term that renders the claim indefinite. The term “polymorphisms” 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. A nucleic acid can only be polymorphic in comparison to another nucleic acid. PUV008 is a BC3F6 plant (¶382) and thus an inbred. Because it is inbred, it will not have polymorphisms within its own genome; polymorphisms can only be seen in comparison to another genome or nucleic acid. The claim does not specify the source of that other genome or nucleic acid, and is thus indefinite.
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 1-29 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.
The claims all require seed of Cucurbita variety PUV008.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public.
The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
It is noted that Applicant has made a deposit of PUV008 at the NCIMB, but it is not clear if the deposit was made under the Budapest Treaty or under US practice. Further, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
It is also not clear what was deposited. Claims 1, 20 and 22 state “tissue” was deposited, while ¶377 states seeds were deposited.
In ¶377 Applicant states that the deposit was made “pursuant to, and in satisfaction of, the requirements of the Budapest Treaty” without actually saying the deposit was accepted under the Budapest Treaty. Applicant also makes statements similar to those required under US practice, but provides no evidence of viability of the deposit. For both, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent. Applicant also does not provide the date the deposit was made.
If the deposit of these seeds was made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and a statement that the deposit was accepted under the Budapest Treaty would satisfy the deposit requirement made herein.
If the deposit was not made and accepted under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Claims 1-29 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 description of PUV008 is incomplete
35 USC 112 requires that the specification have a written description of the invention:
35 U.S.C. 112 Specification.
(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. (emphasis added)
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 examination, including a complete 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 requirement of 35 U.S. Code § 112(a) 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 because applicant failed to provide the breeding history for the instantly claimed plant variety. A plant variety is defined by both its genetics (i.e., its breeding history) and its traits. In the instant application, Applicant has only provided a description of traits of Cucurbita variety PUV008 (Table 1). The instant application is silent as to the breeding history used to produce PUV008.
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 an incomplete 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 the breeding history used to develop Cucurbita variety PUV008. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety. For example, 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 the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one 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 as well (i.e., grandparents).
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also notate 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).
Plants produced by gene modifying PUV008 are not described
Claim 12 is drawn to a plant produced by editing the genome of PUV008, where the plant has the determinate growth habit (of PUV008).
The claim places no limit on the number of genes edited. Claim 12 thus encompasses plants with edits in any number of genes; the only requirement is that the plant has the determinate growth habit.
The structural features that Cucurbita plants produced by editing the genome of PUV008, where the plant has the determinate growth habit from other Cucurbita plants that have the determinate growth habit are not described in the specification.
The only species described in the specification is PUV008 itself. One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the single disclosed species.
Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, PUV008 alone is insufficient to describe the claimed genus.
Hence, Applicant has not, in fact, described Cucurbita plants produced by editing the genome of PUV008, where the plant has the determinate growth habit over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Progeny of PUV008 are not described
The methods of claims 20-25 require a stock Cucurbita plant that has the determinate growth habit and is a product of applying a plant breeding technique to PUV008. Thus, claims 20-25 require a determinate progeny of PUV008.
Dependent claims 21 and 23-25 recite the plant breeding technique. None of the recited techniques place any limit on the determinate progeny of PUV008. For example, pedigree breeding, recited in claims 21 and 23, encompass any number of outcrosses and selfing steps; the resulting plant can be many generations distant from PUV008.
The specification describes no genes that determinate progeny of PUV008 must have. The claims only recite a phenotype, i.e., the function of the gene(s) that confer the determinate growth habit.
The structural features that distinguish determinate progeny of PUV008 from other determinate Cucurbita plants are not described in the specification.
The only species described in the specification is PUV008 itself. One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the single disclosed species.
Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, PUV008 alone is insufficient to describe the claimed genus.
Because determinate progeny of PUV008 are not described in the specification, the methods of using the progeny to produce seeds and vegetatively-propagated plants that have a determinate growth habit are likewise not described, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the compositions used in the claimed methods, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
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 12, 21, and 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Southern Seed Exchange (2020, https://www.southernexposure.com/products/burpee-s-butterbush-winter-squash/) taken with the evidence of Fedco Seeds (https://fedcoseeds.com/ seeds/burpees-butterbush-organic-butternut-squash-1683, accessed 12 November 2024).
Southern Seed Exchange teaches Burpee’s Butterbush Butternut. Fedco Seeds teaches that Burpee’s Butterbush Butternut is determinate. Thus, Burpee’s Butterbush Butternut appears to be a determinate progeny of PUV008.
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, Amjad Abraham, can be reached at (571) 270-7058. 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 1663
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