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 .
Claim Status
Claims 1-14 and 18-19 are examined.
Election/Restrictions
Applicant’s election without traverse of species E20B.20295 in the reply filed on 7/14/2026 is acknowledged.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because the deposit information throughout the specification is missing. Compliance with the deposit requirements may be held in abeyance until allowability is indicated. For example, see page 33 of the instant specification in paragraph 0110 there is a date of deposit listed as “DATE” instead of the date that the seeds were deposited and NCIMB number “X1” instead of the correct accession number.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See paragraphs [0042] and [0044], for example.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The abstract of the disclosure is objected to because it does not indicate that which is new in the art to which the invention pertains. Correction is required. See MPEP § 608.01(b).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-14 and 18-19 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 pre-AIA the applicant regards as the invention.
Claims 1, 11-13 and 19 recite ‘E20B.30395’. ‘E20B.30395’ is not an art recognized term. The use of the name ‘E20B.30395’ does not carry art recognized limitations as to the specific characteristics or essential characteristics which are associated with this denomination. In addition, the name appears to be arbitrary and the specific characteristics associated therewith could be modified. Amending the independent claims to recite the accession number, or the assurance that the claims will be so amended, would overcome the rejection.
Claims 1, 11-12, and 19 recite “NCIMB Accession Number X1”. This is indefinite because the claims do not clearly set forth the metes and bounds of the patent protection desired. Without the accession number for the seeds deposited to the NCMA the scope of the claims is not clear because the representative seeds of the claimed variety are not clear. The claims are vague and indefinite because the accession number is missing because of the requirement that inventor claim what is viewed as the invention.
Therefore, claims 1, 13, 15 and 17 are rejected as indefinite for failing to clearly set forth the metes and bounds of the claims. Claims 2-10, 14 and 18 are rejected for depending from an indefinite claim and failing to recite additional limitations that would render the claims definite.
Claim 5 is 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 pre-AIA the applicant regards as the invention. Claim 5 is indefinite because it is unclear which of the physiological and morphological characteristics of the claimed variety are substantial and which are not, because the specification does not define “substantially all”.
Claim 11 is 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 pre-AIA the applicant regards as the invention. Claim 11 is indefinite because it is unclear which of the physiological and morphological characteristics of the claimed variety are essential and which are not, because the specification does not define “substantially all”.
Claim Rejections - 35 USC § 112
Missing Breeding History
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-14 and 18-19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-14 and 18-19, as they read on the elected species, are drawn to a plant, plant part, or seed of pepper variety E20B.20295, and to methods of making and using the plants, plant parts, seeds, and products.
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 search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
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.").”
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. Applicant specifically claims a new pepper plant variety. A plant variety is defined by both its genetics (breeding history) and its traits. In the instant application, applicant has only provided a description of the plant traits as seen in the specification. The instant application is silent 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” (See “Applying for a Plant Variety Certificate of Protection” by the USDA reference to Exhibit A, www.ams.usda.gov/services/pvpo/application-help/apply). 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 (See UPOV EDV Explanatory Notes 14 and 30, www.upov.int/edocs/expndocs/en/upov_exn_edv.pdf). 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). 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 phenotypes of the claimed plants 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. Plant Physiol. 2010 Nov 29;155(2):645–655, see page 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. (Haun Page 645 right column paragraph 2 to Page 646, left column, paragraph 3). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al. Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap. J. Exp. Bot. 2015 Sep;66(18):5429-40. Epub 2015 Jul 10, see page 5430 left column 1st full paragraph and right column 2nd full paragraph). 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/drawing to provide the breeding history used to develop the instant variety or cultivar. 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).
Deposit Statement
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-14 and 18-19 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.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be 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. The specification does not disclose a reproducible 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 the deposit of the seed is 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 the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria 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;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
The specification and claims must be amended to include the deposit accession number. Compliance with the deposit requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Remarks
It is understood by the Office that “a plant part” encompasses at least one regenerable cell. The Office does not interpret claims drawn to a cell, plant part, protoplast or tissue culture to encompass progeny plant material obtained by crossing ‘E20B.30395’ with a genetically different plant.
Otherwise, rejections under 35 USC 101, 112(a) and/or 35 USC 102/103 may apply. It is understood by the Office that “fruit” refers to a fruit having all the characteristics of ‘E20B.30395’ as described in Applicant’s disclosure.
If Applicant intends to encompass fruits having different characteristics, such as fruits obtained from crossing ‘E20B.30395’ with another plant, then the claims should be amended as such.
The claims are provisionally free of the prior art. A complete search and consideration could not be made without the breeding history. The closest prior art appears to be Tarekegn (US 20220386556), which teaches hybrid pepper variety ‘E20B30329’ which shares many morphological and physiological characteristics with Applicant’s instantly claimed ‘E20B.30395’; however, the varieties differ in at least anther color and anthocyanins in seedling hypocotyl (instant Specification paragraphs 63 and 67; Tarekegn paragraphs 72 and 112).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID R BYRNES/Examiner, Art Unit 1662
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