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 .
Response to Restriction Requirements
Applicant's election without traverse of Group II as hybrid tomato designated 'E15B42750', that encompass claims 1-13, 17-19, 23-25 in the reply filed on 05/14/2026 is acknowledged. Claims 1-13, 17-19, 23-25 are pending.
Accordingly, claims 1-13, 17-19 and 23-25 directed to elected hybrid tomato designated 'E15B42750' are examined on merits in this Office action. Claims 14-16 and 20-22 are cancelled by the Applicant. This restriction is made FINAL.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Specification
The disclosure is objected to because of the following informalities:
Page 35, paragraph [0098] of the specification: The deposit statement lacks NCIMB Accession No. and the date deposit was made.
Appropriate correction is required.
Drawings
Applicant's Petition to accept color drawings under 37 CFR 1.84(a)(2) filed 10/03/2024 has been granted. See Petition decision mailed 11/14/2024.
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claim 1-13, 17-19 and 23-25 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.
Claims 1, 12, 17 and 23 are rejected under 35 U.S.C. 112(b), as being indefinite in their recitation “Accession Number NCIMB X2” because the “NCIMB Accession Number” is missing.
Claims 1, 12, 17, 18 and 23 are rejected under 35 U.S.C. 112(b) as being indefinite in their recitation hybrid tomato 'E15B42750' because the recitation does not clearly identify the claimed tomato variety and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name 'E15B42750' is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of the hybrid tomato plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the NCIMB deposit number.
All the dependent claims are also rejected because they fail to overcome the deficiencies of parent claims.
Claim Rejections - 35 USC § 112 - written description requirement
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 1-13, 17-19 and 23-25 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 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.
Applicant’s attention is drawn to paragraph [0072] at lines 1-3, wherein the specification states:
“When the terms "tomato plant", "hybrid", "cultivar", or "tomato line" are used in the context of the present disclosure, this also includes any single gene conversions of that variety.”
specification states in paragraph 0071:
“As used herein, the term “plant” includes plant cells, plant protoplasts, plant cell tissue cultures from which tomato plants can be regenerated, plant calli, plant clumps and plant cells that are intact in plants or parts of plants, such as embryos, pollen, ovules, flowers, leaves, stems, and the like.”
In light of above, the specification does not disclose what single gene conversions are encompassed by the claimed variety. Thus, the claims encompass tomato plants that have any number of heritable traits and which differ from tomato variety 'E15B42750' as disclosed in Tables 3 and 4 by an unknown number of physiological and morphological characteristics.
The specification describes no structural features that distinguish plants that differ from the tomato variety 'E15B42750' in any number of traits from other tomato plants. The specification however, only describes variety 'E15B42750' as disclosed in Tables 3 and 4. The specification fails to describe a representative number of plants with heritable traits that differ from those in variety 'E15B42750' as disclosed in Tables 3 and 4. Thus, the full scope of the claimed genus of plants has not been adequately described and is not in Applicant's possession at the time of filing. Because the claimed plants lack adequate written description, the claimed methods of using said plants also lack adequate written description. Accordingly, all claims including claims 20 and 21 are also included in the rejection.
Claims 3-5, 7, 8 and 10 are directed to F1 progeny embryos and seed cells derived from hybrid tomato 'E15B42750'. Because 'E15B42750' is heterozygous at all genetic loci, the genetic composition of its F1 progeny resulting from a cross with an unidentified parent cannot be predicted. The specification does not provide data for a sufficient number of F1 progeny plants to enable a person of ordinary skill in the art to reasonably anticipate their genetic constitution or their physiological and morphological traits. Moreover, the application fails to identify distinguishing characteristics of the claimed F1 progeny. In the absence of such information, a skilled artisan cannot reliably determine the genomic structure or observable characteristics of the claimed progeny. As a result, the claims directed to plant parts and protoplasts comprising embryos and seed cells of hybrid tomato ‘E15B42750’ do not satisfy the written description requirement.
Claims 3, 4, 7, and 9-11 encompass reproductive structures—specifically pollen, pollen grains, anthers, and ovules—that contain haploid cells. These claims also fail to meet the written description requirement. Because hybrid tomato 'E15B42750' is heterozygous at every locus, meiotic division produces haploid cells with unpredictable combinations of alleles. Consequently, neither the genetic makeup of the claimed haploid cells nor the physiological or morphological characteristics of plants derived from those cells can be anticipated by a person skilled in the art. Accordingly, the claims directed to pollen, pollen grains, anthers, ovules, and other haploid cells lack adequate written description.
Claim 6 recites a plant that retains essentially all of the physiological and morphological characteristics of the tomato plant of claim 2. However, the application does not clarify which specific characteristics are considered essential, nor does it indicate the extent to which the traits disclosed in Tables 3 and 4 are preserved, modified, or absent in the claimed plant. Without such guidance, it is not possible to determine the characteristics of the claimed plant with any degree of predictability. Therefore, claim 6 is not supported by an adequate written description.
Claim 12 relates to a plant regenerated from tissue culture that purportedly maintains essentially all of the physiological and morphological characteristics of hybrid tomato 'E15B42750'. The specification, however, does not demonstrate that this result can be achieved. As recognized in the literature, including Barwale et al. (Plant Cell Reports , 1987, 6:365-368) that plants regenerated through tissue culture may exhibit somaclonal variation, leading to altered physiological and morphological traits. Given this variability (page 365, Abstract), it is not possible to predict which characteristics will be present in the regenerated plant or how they may differ from the original hybrid. Accordingly, the claim directed to a plant regenerated from tissue culture is not adequately described.
In summary, the specification fails to describe representative structure of the broadly claimed genus and further fails to correlate such structures to a function. The specification fails to establish structure and function correlation for a representative species as encompassed by the breadth of the claims.
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 hybrid tomato ‘E15B42750' variety which is a F1 hybrid with specific number of characteristics as described in Tables 3-4.
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, hybrid tomato E15B42750 variety 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.
Claim Rejections - 35 USC § 112 (Written Description-Breeding History)
Regarding claims 1-13, 17-19 and 23-25, 35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new tomato variety E15B42750. So, the examiner will evaluate what is an adequate written description for a new tomato variety. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in table 3 (see pages 17-20). However, there is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
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)).
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)).
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.
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.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
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).
The breeding history aids 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.
Moreover, a specification devoid of a complete 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 complete 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.
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 instantly claimed tomato variety. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instantly claimed tomato variety and all other potential names for the instantly claimed tomato variety. If Applicant’s breeding history uses proprietary cultivar/variety/inbred line names, Applicant should notate in the specification all other names of the proprietary cultivars/varieties/inbreds, especially publicly disclosed or patented cultivar/variety/inbred 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 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 cultivar/variety). If there 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).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant’s attention is drawn to the line 15 of paragraph [0059] at page 16 of the specification which says:
“Hybrid tomato ‘E15B42750’ is the result of numerous generations of plant selections from its parent lines,”
Applicant included no breeding history for hybrid tomato variety ‘E15B42750’ in the specification. No additional names for all parent(s) involved in creating hybrid tomato variety ‘E15B42750’ is disclosed in the specification. This disclosure is insufficient and incomplete because it does not address all the issues set forth above
Thus, the breeding history for the claimed hybrid tomato variety ‘E15B42750’ as disclosed in the specification is incomplete by just stating “Hybrid tomato ‘E15B42750’is the result of numerous generations of plant selections from its parent lines [0059] of page 16 of the specification. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed Hybrid tomato ‘E15B42750’.
It must be noted that there is natural variation in tomato caused by genetics and environment.
Applicant’s attention is drawn to paragraph [0072] at lines 1-3, wherein the specification states:
“When the terms "tomato plant", "hybrid", "cultivar", or "tomato line" are used in the context of the present disclosure, this also includes any single gene conversions of that variety.”
specification states in paragraph 0071:
“As used herein, the term “plant” includes plant cells, plant protoplasts, plant cell tissue cultures from which tomato plants can be regenerated, plant calli, plant clumps and plant cells that are intact in plants or parts of plants, such as embryos, pollen, ovules, flowers, leaves, stems, and the like.”
In light of above, the specification does not disclose what single gene conversions are encompassed by the claimed variety. Thus, the claims encompass tomato plants that have any number of heritable traits and differ from tomato variety ‘E15B42750’ as disclosed in Table 3 by an unknown number of physiological and morphological characteristics. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of tomato plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed tomato variety ‘E15B42750’, including all names for the parents and for the claimed tomato variety tomato variety ‘E15B42750’ are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Claim Rejections - 35 USC § 112 – Enablement
Claims 1-13, 17-19, 23-25 are rejected under 35 U.S.C. 112(a) 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 of hybrid tomato designated ‘E15B42750' 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 (25 packets of 25 seeds each) seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
It is noted a deposit of the seeds of hybrid tomato variety ‘E15B42750’ that is essential to the claimed invention has been made at the NCIMB (see paragraph [0098] at page 35 of the specification). But the terms of the deposit are not clear. In the instant case, for example, the deposit information lacks the statement that “all restrictions upon availability to the public will be irrevocably removed upon granting of the patent”. Additionally, there is no evidence from NCIMB that seeds of hybrid tomato variety ‘E15B42750' were actually deposited. The cited paragraph lacks the NCIMB deposit number and date of deposit. A copy of original receipt from NCIMB must also be provided to overcome this rejection.
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.
Applicant has NOT indicated that Applicant intends to deposit the seeds at the NCIMB in accordance with 37 CFR 1.801-1.809.
Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the NCIMB Accession Number and evidence of deposit to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Conclusion
No claim is allowed.
The claims appear to be free of prior art. The closest prior art is Silvertand et al. (US Patent No.: US 10,750,710 B2, Date of Patent: Aug. 25 , 2020). Silvertand et al. teaches a hybrid tomato hybrid of NUN 090220 TOF, wherein many of the morphological and physiological traits of instant tomato hybrid cultivars and the NUN 090220 TOF are similar (see cols. 25-29). However, the instant tomato hybrid cultivars and the NUN 090220 TOF differs in the disease resistance traits showed Spec, page 18-19, shape of transverse section of fruit in NUN 090220 TOF is angular, shape of blossom end is indented, pistil car is dot etc. are different from the Applicant’s tomato hybrid variety 'E15B42750'. However, a complete search at this time is not possible because applicant have not provided any the breeding history of the hybrid cultivar 'E15B42750’ to enable a complete and meaningful search of the prior art.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANTOSH SHARMA whose telephone number is (571)272-8440. The examiner can normally be reached Mon-Fri 8:00 AM - 5:00 PM.
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 A. 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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/SANTOSH SHARMA/Examiner, Art Unit 1663
/DAVID H KRUSE/Primary Examiner, Art Unit 1663
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