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 1-20 are pending and are examined in the instant application.
Specification
2. The disclosure is objected to because of the following:
The Abstract is objected to because scientific names are not capitalized and italicized. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The specification is objected to because scientific names, e.g., Verticillium, Fusarium, etc., are not capitalized and italicized throughout the specification. See paragraphs [0004] and [0006], for example.
In Table 1, it is unclear what unit of measurement is used for the plant height.
In Table 1, it is unclear what “protrude” means with regard to stem branching. What are other types of branching?
In Table 1, there are two recitations of “Ripening”. It is unclear how they differ from each other.
In Table 4, it is unclear what “Y-1” and “Y-2” denote.
Appropriate correction is required.
Claim Objections
3. Claims 13 and 20 are objected to because of the following:
In claim 13, “a F1” should be amended to “an F1”.
In claim 20, line 4, “wherein” should be inserted after the comma.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
4. 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 4, 7, 10, 13-15 and 20 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.
In claims 4 and 7, these claims recite “pollen” and “portion thereof containing at least one regenerable cell of tomato variety ‘H2531’”. Because pollen is a single cell, it is unclear what portion of the pollen contains at least one regenerable cell. It is suggested the phrase containing “portion thereof” be deleted.
In claim 10, it is unclear how a tissue culture has all the physiological and morphological characteristics of tomato variety H2531. A tissue culture is a subset of cells of the plant and thus does not have all the physiological and morphological characteristics of tomato variety H2531. Does Applicant mean a plant regenerated from the tissue culture has all the physiological and morphological characteristics of tomato variety H2531?
In claim 13, it is unclear what is retained in the “derived” product. It is unclear what additional method steps are required to produce the derived plant. It is suggested “derived” be amended to “obtained”.
Claim 13 is directed to a method of producing a tomato plant derived from tomato variety ‘H2531’. This is an incomplete method claim because it does not result in producing a tomato plant derived from tomato variety ‘H2531’. The claimed method produces an F1 hybrid tomato plant.
In claim 20, the recitation of Table 1 is not permitted. See MPEP 2173.05(s), which states:
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation be reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
There is no evidence that the information from Table 1 cannot be reproduced in claim 20. It is suggested the recitation of “listed in Table 1” be deleted.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(d)
6. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), 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.
7. Claims 5-7, 16 and 17 are 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.
Claim 5 is directed to a plant having all the physiological and morphological characteristics of the tomato plant of claim 2. The plant of claim 2 has a specific set of chromosomes as represented by the deposit. However, the plant of claim 5 is not required to have the same specific set of chromosomes as represented by the deposit. The plant of claim 5 is only required to have all the physiological and morphological characteristics of the tomato plant of claim 2. Thus, claim 5 does not contain all the limitations set forth in claim 2.
Claims 6 and 7, which depend from claim 5, recite “comprises at least one cell of tomato variety ‘H2531’”. However, the plant of claim 5 is not required to have at least one cell of tomato variety H2531. Thus, as claims 6 and 7 are directed to a plant part containing a cell that is not present in the plant of claim 5, these claims do not further limit claim 5.
With regard to claims 16 and 17, the introduction of a transgene or single locus conversion would alter the base genome of hybrid variety H2531. When a transgene or single locus conversion is introduced into the plant of claim 2, the transgene or single locus conversion is not simply being added to the base plant genome but causes rearrangements and possible deletions in said genome. Thus, the addition of a transgene or single locus conversion does not further limit the scope of the claim it depends from.
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 § 112(a)
8. 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.
9. Claims 1-20 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 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, line 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. All other potential names for the claimed variety should also be set forth. 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 the instant plant variety 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 any patent applications or patents in which sibs, progenies or parents of the instant plant are claimed, the serial numbers and names of the sibs, progenies or parents should be disclosed. This information can be submitted in an Information Disclosure Statement (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).
Applicant’s disclosure is insufficient because it does not address the issues set forth above.
Correction is required.
10. Claims 3, 4, 6-9, 16 and 17 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.
In addition to the written description above, the claims lack adequate written description for the following reasons. The specification defines a plant part to encompass an F1 progeny seed or cell obtained from said seed [0009]. Thus, claims 3, 4, 6 and 7 encompass F1 progeny embryo and seed cells (a fruit contains progeny seeds). Because variety H2531 is a hybrid, its genome is heterologous at every locus. When H2531 is crossed with an unknown parent, it is unpredictable what genetic material its F1 progenies would inherit. The specification does not disclose a representative number of F1 progenies of the deposited hybrid to allow one skilled in the art to predict the genetic makeup or physiological and morphological characteristics of the claimed F1 progenies. No identifying characteristics are set forth for the F1 progenies. There are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine the genomic structure or morphological and physiological characteristics of the claimed F1 progenies, absent further guidance. Accordingly, the claimed plant parts lack adequate written description.
With regard to claims 3, 4 and 6-9, which encompass pollen, anther and ovule (contains haploid cells), these claims lack adequate written description because Applicant is claiming haploid cells of hybrid tomato H2531. The genome of hybrid variety H2531 is heterologous at every locus. The art teaches that the tomato genome has about 35,000 genes (US Pub. No. 20240415127 (A), [0002]). When its diploid genome segregates to form haploid cells, it is highly unpredictable which combination of alleles from each of the 35,000 genes are present in the haploid cells. During meiosis to produce the haploid cells, it is unpredictable which reassortment of dominant and recessive alleles of hybrid tomato H2531 would be present in the haploid cells. One skilled in the art cannot predict the genetic makeup of the claimed pollen, anther and ovule. Accordingly, the claimed pollen, anther and ovule are not adequately described.
With regard to claims 16 and 17, the claims do not indicate how the transgene or single locus conversion was introduced into hybrid variety H2531. The specification utilizes the terms “transgene” and “single locus conversion” interchangeably [0014]. The recitation of “one or more transgenes” in paragraph [0026] indicates that Applicant intends to encompass more than one transgene or single locus conversion. Thus, the claims encompass the introduction of any number of transgenes or single locus conversions by any means, including by outcrossings with undisclosed plants. It is not known what physiological and morphological characteristics of tomato variety H2531 are retained after said outcrossings, as outcrossings with genetically different plants would introduce characteristics which are not present in variety H2531 in addition to the transgenes or single locus conversions. Aside from the traits introduced by the transgenes or single locus conversions, the resulting plant may have morphological and physiological characteristics which are significantly different from those disclosed for hybrid variety H2531. However, it is not known what those characteristics are or how they differ from hybrid variety H2531. Thus, the claimed plants obtained by any method of introducing a transgene or single locus conversion into hybrid variety H2531 are not adequately described.
Accordingly, the claimed invention lacks adequate written description under current written description guidelines https://www.uspto.gov/sites/default/files/web/menu/written.pdf.
11. Claims 16 and 17 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).
Claims 16 and 17 are directed to a tomato plant of tomato variety H2531 further comprising a transgene or single locus conversion produced by any method, including outcrossing with undisclosed plants. These claims are not enabled because variety H2531 is a hybrid (Title), whereby its genome is heterologous at every locus. Outcrossing of hybrid tomato variety H2531 with an undisclosed parent, then backcrossing to hybrid tomato variety H2531, would not regain all or most the morphological and physiological characteristics of hybrid tomato variety H2531 due to the presence of heterologous dominant and recessive alleles at every locus of the genome. The state of the prior art does not teach the introduction of a transgene or a single locus conversion to a hybrid plant by outcrossing and backcrossing to said hybrid plant to produce a converted progeny plant having all the morphological and physiological characteristics of said hybrid plant. The art teaches that the first absolute requirement for a successful backcross program is that the recurrent parent is an inbred line (Plant & Soil Sciences eLibrary 2023, downloaded Aug. 26, 2023 (UU), first page, last paragraph). Otherwise, the recurrent parent goes through meiosis to produce pollen or an ovule, and the genome is not the same as the genome of hybrid tomato variety H2531. 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 transgene or single locus conversion, if at all. It is highly unpredictable what combinations of dominant and recessive alleles at every locus would be present in each backcrossed progeny.
Given the state of the prior art, the lack of guidance, lack of working examples, and the unpredictability in the art, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
Conclusion
12. No claim is allowed. The claims are free of the prior art. The closest prior art teaches tomato variety H1996 which shares at least 57 physiological and morphological characteristics with Applicant’s variety H2531, including the same or similar (+/- 10% std. dev.) anthocyanin in hypocotyl, determinate growth type, number of nodes below first inflorescence, leaf morphology, surface of major leaflets, calyx lobes, anthers, typical fruit shape, point of detachment of fruit, fruit color full ripe, number of locules, locular gel color, absence of core, ripening pattern, serum viscosity, juice Bostwick, soluble solids as Brix, machine harvest adaptation, and resistance / susceptibility to tomato spotted wilt virus, Fusarium oxysporum f. lycopersici Races 1-3, Verticillium dahlia Race 1 and root knot nematode (Ozminkowski, Jr., R., US Pub. No. 20210185970, Tables 1-4 (A)). However, at least their plant height, plant habit, onset of leaf rolling, inflorescence type, shape of stem end, epidermis texture, thickness of pericarp and resistance / susceptibility to bacterial speck (Pseudomonas tomato) differ.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Phuong Bui whose telephone number is 571-272-0793.
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 on 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