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 .
DETAILED ACTION
Claims 1-22 are pending and examined on the merit.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Deposit of Biological Material
3. 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 having made an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809. See ¶190-191 and the evidence filed 23 December 2025 of acceptance of the deposit under the Budapest treaty.
Claim Objections
4. Claims 9 and 19 are objected to because of the following informalities:
Claims 9 and 19 are objected to because -said method-- should be inserted after the comma in line 1.
Claim Rejections - 35 USC § 112
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.
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.
5. Claims 5, 8, 19 and 21-22 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 5 is indefinite in its recitation of “wherein said part is … a cell culture, or a tissue culture”, as cell and tissue cultures are not parts of a plant.
Claim 8, line 1, claim 19, line 11, and claim 21, lines 1 and 2, are indefinite of their recitation of “melon”, as NUN 32316 WMW is a watermelon, not a melon.
Lack of breeding history
6. Claims 1-22 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 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. 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 watermelon variety NUN 32316 WMW. Specifically, in claim 1 applicant claims a new watermelon variety NUN 32316 WMW. 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 (see pages 44-46). The instant application is silent or incomplete as to the breeding history used to produce the claimed watermelon variety NUN 32316 WMW.
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.). 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). 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. HAUN teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun 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. (See Haun Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky 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).
7. Claims 2-3 and 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 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.
Claim 2 is drawn to a plant part of the plant of claim 1, where the plant part is pollen or an ovule.
NUN 32316 WMW is a hybrid produced by crossing unidentified watermelon varieties (paragraph [0191]).
As NUN 32316 WMW is a hybrid plant, when pollen and ovules are produced from it, a mixture of gametes that will all differ from one another are produced. None will have all the genetics of NUN 32316 WMW.
The specification fails to describe the structural features (genetics) of pollen and ovules from NUN 32316 WMW and describes no species of pollen and ovules from NUN 32316 WMW. The specification fails to describe the common attributes that identify members of the genus. The specification fails to describe the structural features that distinguish pollen and ovules from NUN 32316 WMW from pollen and ovules from other watermelon plants, including pollen and ovules from NUN 32316 WMW’s progeny.
Hence, Applicant has not, in fact, described pollen and ovules from NUN 32316 WMW, 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.
Claim 3 is drawn to a watermelon plant, or a part thereof having all the physiological and morphological characteristics of the plant of claim 1 or part thereof when grown under the same environmental conditions.
The claim is interpreted to encompass any watermelon plant that matches all the physiological and morphological characteristics of NUN 32316 WMW.
Applicant describes the claimed variety NUN 32316 WMW by virtue of a list of morphological and physiological characteristics (Table 1, p. 44-46), and a deposit.
Applicant does not describe the broad genus of any plant that matches all the physiological and morphological characteristics of NUN 32316 WMW other than NUN 32316 WMW and its immediate derivatives. Such plants would include plants with a vast number of combinations of genes from any number of parental lineages that cannot be distinguished from NUN 32316 WMW by virtue of the listed traits alone. It is reasonable to conclude that other soybean plants that do not share the same parentage as 5PRSF13 would be indistinguishable on the basis of the listed traits. Such plants would not be described by a deposit, nor would they be described by a breeding history described in the instant disclosure.
Hence, Applicant has not, in fact, described the claimed invention within the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Claim 22 is drawn to any genetically modified watermelon plant produced by a method used for modifying said plant wherein the method comprises mutation, the plant produced by the method of claim 21.
The breadth of claim encompasses plant(s) with unknown changes in unknown loci as result of mutation, in multiple target genes using gene editing approach.
The breadth of claim encompasses a genus having species with unknown structures(s) whose function cannot be reliably determined.
Applicant’s broadly claimed genus encompasses species whose structure is unknown and hence their function is either unknown or unpredictable.
The only species described is a watermelon variety NUN 32316 WMW with specific number of characteristics as described in Table 1.
The specification fails to describe representative species of Applicant’s broadly claimed genus.
There is no description of the structure required for the recited function, and no description of the necessary and sufficient elements of functional activity of diverse structures encompassed by Applicant’s broadly claimed genus is thus unknown.
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 disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, watermelon variety NUN 32316 WMW is insufficient to describe the claimed genus.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing.
It is suggested to insert the recitation ---wherein the modified watermelon plant has all of the morphological and physiological traits of said watermelon variety NUN 32316 WMW and the desired trait---at the end of the claim to overcome this rejection.
Conclusion
No claims are allowed.
The closest prior art is US patent application publication NO. 2024/0081212, which teaches a watermelon variety designated NUN 312136 WMW which shares some of the same traits (e.g. yellow flower color, leaf shape) as the instantly claimed watermelon variety, however, it differs at least in fruit shape, ploidy, as well as several other traits.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRATISLAV STANKOVIC can be reached on 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LI ZHENG/Primary Examiner, Art Unit 1662
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