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
1. Claims 1-25 are pending and are examined in the instant application.
Information Disclosure Statement
2. Applicant’s Information Disclosure Statement (IDS) filed January 31, 2024 has been considered. A signed copy is attached.
Specification
3. The disclosure is objected to because of the following:
In the Abstract, the recitation of “new and distinct” is objected to because novelty has not been established during examination and is presumed upon a patent grant. It is suggested that the recitation of “new and distinct” be deleted.
Appropriate correction is required.
Claim Objections
4. Claims 1-25 are objected to because of the following:
In claims 1, 6, 7, 9 and 16-18, “sample of seed … has been deposited” should be amended to “sample of seeds … have been deposited”, because more than one seed has been deposited.
In claim 7, line 2, the recitation of “a part thereof” should be amended to “part thereof” or “the part thereof” since it is referring to “a part thereof” in line 1.
In claim 7, line 3, “the plant of” should be deleted.
In claim 17, “of tomato variety NUN 08801 TOF” should be inserted before “of claim 1” for consistency with the last “wherein” clause. Additionally, “and” should be inserted before the last “wherein” clause.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
5. 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.
6. Claims 24 and 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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 24, absent a deposit recitation, the metes and bounds of “tomato variety NUN 09901 TOF” cannot be determined.
Dependent claim 25 is included.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(d)
7. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection I, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
8. Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The “comprise” language in claim 23 does not further limit the plant breeding techniques set forth in claim 22. It is suggested “comprise” be amended to a closed Markush grouping.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
9. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
10. Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process and a routine activity without significantly more. The claim recites obtaining nucleic acids from a plant, detecting a plurality of polymorphisms, thereby determining the genotype of the plant, and storing the results of said detecting on a computer readable medium. No particular method for detecting the polymorphisms or the polymorphisms to be detected is recited. No genotype is recited. This judicial exception is not integrated into a practical application because obtaining nucleic acids is a routine activity, detecting polymorphisms and determining the genotype are mental processes or data gathering steps, and storing the results on a generic computer readable medium amounts to simply implementing the mental steps onto a computer readable medium. This is considered an insignificant extra-solution activity that is a well-understood, routine and conventional in the art. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the obtaining nucleic acids step, the detecting / determining step and the storing of the results of said detecting on a computer readable medium do not add significantly more to the inventive concept. Thus, the claimed method lacks an inventive concept. Moreover, it should be noted that the claimed method would preclude the public from the mere determination of whether or not Applicant’s invention is infringed.
Claim Rejections - 35 USC § 112(a)
11. 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.
12. 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 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. Specifically, in claim 1, Applicant claims a new tomato 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 shown in the specification. The instant application is silent or 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” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)). 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, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)). 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 the plants are 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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). 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 et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 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 (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 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 to adequately 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, as well as all other potential names for the claimed variety or cultivar. 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 should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as of the instant plant should be set forth.
Applicant is 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). If there are any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. 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).
Correction is required.
13. Claim 25 is 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 25 lacks adequate written description because it is unpredictable what morphological and physiological characteristics of tomato variety NUN 08801 TOF are altered or deleted after the mutating step in claim 24. There is no disclosure of the target gene and how mutating said target gene changes the base genome or the morphological and physiological characteristics of tomato variety NUN 08801 TOF. The mutated plant may have morphological and physiological characteristics that significantly differ from those of tomato variety NUN 08801 TOF. Accordingly, the claimed mutated tomato plant lacks adequate written description.
14. Claims 19, 24 and 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 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.
Enablement factors to consider include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)
With regard to claim 19, tomato variety NUN 08801 TOF is a hybrid [0179], whereby its genome is heterologous at every locus. The tomato genome possesses about 35,000 genes (US Pub. No. 20240415127 (A), paragraph [0002]). Outcrossing of tomato variety NUN 08801 TOF with an undisclosed parent, then backcrossing to tomato variety NUN 08801 TOF, would not regain all or most the morphological and physiological characteristics of tomato variety NUN 08801 TOF due to the presence of heterologous dominant and recessive alleles at every locus of the genome of hybrid tomato variety NUN 08801 TOF. Applicant has no working example of a plant produced by the claimed method. Paragraph [0087] of the specification states “In case of a hybrid, the gene may be introduced in the male or female parental line.” However, the parent lines of hybrid tomato variety NUN 08801 TOF are not recited. The state of the prior art does not teach the introduction of a single locus conversion to a hybrid plant by outcrossing and backcrossing to said hybrid plant to produce a converted plant having otherwise all the morphological and physiological characteristics of said hybrid plant. While one skilled in the art can backcross a hybrid progeny to its hybrid parent, there is no guidance as to how many backcrossings to the hybrid parent are required to regain all of its morphological and physiological characteristics in addition to the single locus conversion. It is highly unpredictable what combinations of dominant and recessive alleles at every locus would be present in each backcrossed progeny. Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
With regard to claim 24, tomato variety NUN 08801 TOF is essential to the claimed invention but does not appear to be reproducible by a disclosed method in the specification or readily available to the public. Absent a deposit recitation, one skilled in the art cannot make and use the claimed invention without undue experimentation. Because the method of claim 24 is not enabled, the tomato plant produced therefrom (claim 25) is also not enabled.
Claim Rejections - 35 USC §§ 102 and 103
15. 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 (i.e., changing from AIA to pre-AIA ) 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.
16. 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.
17. 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.
18. Claim 25 is 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 Silvertand, B. (US Pub. No. 20210105971 (B)).
As stated in the written description rejection above, the claimed plant lacks adequate written description. The claimed plant is not required to retain all the morphological and physiological characteristics of tomato variety NUN 08801 TOF in addition to the desired trait. The prior art teaches tomato variety NUN 09271 TOF which shares at least 40 characteristics with Applicant’s tomato variety NUN 08801 TOF, including plant height, plant vigor, plant habit, stem branching, nature of stigma, shape of apex, anthocyanin coloration of hypocotyl, growth type, attitude of mature leaf in relation to main stem, leaf width, type of leaf blade, leaf blistering, inflorescence type, color of flower, pubescence of style, abscission layer, green shoulder of fruit before maturity, ribbing at peduncle end, depression at peduncle end, size of blossom scar, shape of blossom end, color of fruit at maturity, color of fruit flesh at maturity, fruit firmness, time of flowering and resistance to Fusarium oxysporum f. sp. lycopersici Races 0 and 1, F. oxysporum f. sp. radicis lycopersici, Passalora (Fulvia) fulva Groups A-E, tomato mosaic virus Strains 0, 1, 2 and 1-2, and Oidium neolypersici (Tables 1-3).
Accordingly, the claimed invention is anticipated by, or in the alternative, is obvious in view of the prior art. See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejected over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products. Since the Patent Office does not have the facilities to examine and compare the plant of Applicant’s with that of the prior art, the burden of proof is upon the Applicant to show an unobvious distinction between the claimed plant and the plant of the prior art. See In re Best, 562F.2d 1252, 195 USPQ 430 (CCPA 1977).
Conclusion
19. No claim is allowed. It is understood by the Office that “part” encompasses at least one regenerable cell. In claim 1, “seed of tomato variety NUN 08801 TOF” is the seed as represented by the deposit. Additionally, claims directed to a fruit obtained from a plant of NUN 08801 TOF is understood to be the NUN 08801 TOF fruit as described in the Tables in Applicant’s disclosure.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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, 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.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663