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 .
Claims
Claims 1-22 are pending and are examined in this Office Action.
Duty of Disclosure
Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered material to patentability includes: 1) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 2) if backcrossing was used in the breeding history, then the recurrent parent should be disclosed along with any publications or public disclosures of the recurrent parent, and what events/loci/transgenes/traits were donated from the non-recurrent parent along with any publications or public disclosures of the events/loci/transgenes/traits or of the donor parent line itself, 3) if the parental varieties were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/transgenes/traits were donated from the non-recurrent parent, 4) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants (if backcrossing was used for the parents) should be disclosed. All of this information is material to patentability. If, for example, one of the parent plants is published but with a different name/designation, then the publication should be included in the IDS along with an explanation that the different name/designation is a synonym and how this plant is related to the instantly claimed plant.
It is noted that Applicant provided two alternative designations for the instant pea variety (Spec 8 ¶ 30). The Examiner thanks Applicant for including this information because it facilitates a complete search.
Claim Objections
Claims 16 and 17 are objected to because of the following informalities:
Claims 16 and 17 recite “ ... crossing the plant of claim 1 with itself ...” and “crossing the bean line SVQF0500-derived bean plant with itself ...” and this is incorrect because “crossing” involves two different plants rather than having a plant pollinating “itself” (Spec 28 ¶¶ 80-81, Spec 29 ¶ 96).
Appropriate correction is requested.
Claim Interpretation
The words “variety” and “line” are used interchangeably throughout the specification, and therefore they are interpreted to have the exact same meaning in the context of the instant pea line/variety SVQF0500.
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.
Claims 1-22 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 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are all directed to plants or plant parts of pea variety SVQF0500 or plants derived from said variety or methods that utilize said variety.
The instant specification includes the following definition:
In another aspect of the invention, a plant of pea line SVQF0500 comprising an added heritable trait is provided. The heritable trait may comprise a genetic locus that is, for example, a dominant or recessive allele. In one embodiment of the invention, a plant of pea line SVQF0500 is defined as comprising a single locus conversion. In specific embodiments of the invention, an added genetic locus confers one or more traits such as, for example, herbicide tolerance, insect resistance, disease resistance, and modified carbohydrate metabolism ... ... a genetic locus may comprise one or more genes integrated at a single chromosomal location. (Spec 3-4 ¶ 11).
The instant specification also provides this definition:
Single Locus Converted (Conversion) Plant: Plants which are developed by a plant breeding technique called backcrossing or genetic engineering of a locus wherein essentially all of the morphological and physiological characteristics of a pea variety are recovered or conserved in addition to the characteristics of the single locus. (Spec 29 ¶ 97).
This adds confusion regarding the metes and bounds of claim 1 because it is unclear if the deposited seeds already have a locus conversion. If so, what is the single gene conversion relative to? Did the plants that were grown to collect the data in Table 1 already have a locus conversion? Because the plants of the “line” encompass plants with single locus conversions, it is important to have a very clear definition of what a non-converted plant of the line is.
The instant specification provides a trait table containing physiological and morphological characteristics of pea line SVQF0500 (Spec 9-12). Is this description valid for ALL plants of variety SVQF0500? Or is this description valid only for the non-converted plants within variety SVQF0500? Were the plants utilized to collect the traits for this trait table grown from the same batch of seeds as the seeds that were deposited under NCMA Accession No. 202403010 (Spec 29)? Or is there a locus conversion/gene conversion between the seeds that were deposited and the seeds utilized to grow plants for the data in the trait table?
Given that “plant of pea line SVQF0500” is inclusive of locus conversions that allow for having changes in the morphological and physiological characteristics, it is unclear which characteristics are absolutely required to be a member of this variety. If a locus conversion is only required to have “essentially all” of the characteristics, how many of the characteristics are required?
See Nautilus, Inc. v. Biosig Instruments, Inc, No. 13-369, in which the Supreme Court held that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.
One skilled in the art understands that introducing a locus/gene conversion is carried out by cross-pollinating the recipient plant with a different plant that has the desired locus/trait to be added. This produces an F1 hybrid which is subsequently cross-pollinated back to a plant of the original recipient germplasm in the technique called “backcrossing” (see Fehr, (Iowa State University, "Principles of Variety Development," Vol. 1 Theory and Technique and Vol. 2 Crop Species, Soybean, Macmillian Publishing Company, New York (1987) pp. 360-376). The amount of genomic DNA from each plant depends upon the number of generations of backcrossing that has been carried out (see Fehr, page 370, Table 28-2). It is possible to backcross enough times to arrive at a plant that has “almost 100% of its original genes” and also the newly added desired gene (see Fehr, page 362) or one can carry out a single backcross to arrive at a plant that, on average, would have only 75% of the original genes (see Fehr, Table 28-2). One skilled in the art also understands that sometimes additional genes are linked to the desired gene and the linked genes can introduce additional traits (see Fehr, page 371).
In this case, it is unclear what characteristics must be retained after back-crossing for a plant to have “essentially all” of the characteristics.
The Cambridge Dictionary defines “essentially” as “relating to the most important characteristics or ideas of something" (downloaded from https://dictionary.cambridge.org/us/dictionary/english/essentially on Oct. 25, 2023). It is unclear which characteristics of a plant produced by locus conversion and/or back-crossing are considered "essential", and it is unclear how many of the characteristics would need to be present to satisfy the limitation that “essentially all” of the characteristics are present.
Within the US Patent literature, there are numerous examples of different interpretations of the word “essentially”, some are provided here:
US 2013/0291219 A1, paragraph 0011, which states “Essentially homogeneous corresponds to “at least about 97%” inbred seed.”, and this definition allows for about 3% variation.
US 2014/0072693 A1, paragraph 0007, which states "essentially homogeneous population of lettuce seed is exemplified to have at least about 97% of the total seed, including at least about 98%, 99%, or more of the seed", and this example allows for "about" 1%, 2%, or 3% variation.
US 2014/0228479 A1, paragraph 0039, which states ““essentially saturated” diene elastomers (low or very low content of units of diene origin, always less than 15%)”, and this allows for up to a 15% variation.
US 2014/0224707 A1, paragraph 0033, which states “essentially horizontal is defined as a variation of the slope of a plane or a straight line with respect to the vertical, or with respect to the horizontal, of an angle .alpha. of between +/- 5 degrees”, and this allows for 5.6% variation relative to 90 degrees, and 11% variation relative to 45 degrees.
US 2014/0223669 A1, paragraph 0020, which states “as defined herein, “essentially free of a component” means that no amount of that component is deliberately incorporated into the composition.”.
This limited sampling of US Patent publications demonstrates widely varying definitions for "essentially".
A review of the prosecution history did not shed any light on the meaning of the ambiguous language of “essentially all”. For these reasons, the claims are indefinite because one of skill in the art, in light of the specification and prosecution history, would not know with reasonable certainty what the scope of the claimed invention is.
Claims 4 and 6 are specifically indefinite because they require “all of the physiological and morphological characteristics of the plant of claim 1” (claim 4) and “all of the physiological and morphological characteristics of pea line SVQF0500” (claim 6), and it is unclear which characteristics are required to be a member of pea line SVQF0500.
Claims 14 and 15 confuse things further because it is directed to a plant of the instant pea line further comprising a “single locus conversion”; however, the instant specification defines a plant of pea line SVQF0500 as already comprising a single gene conversion. The common meaning for “single” means just one, however, this claim clearly encompasses adding one to a plant that already has one, which results in more than a “single”. The specification also clearly states that “a” or “an” denotes “one or more” (Spec 27 ¶ 77), therefore, if “single” does not mean one and only one, then “a” does not provide any limitation on the number of gene conversions/locus conversions that are encompassed by these claims. It also remains unclear what the baseline unconverted plant is, so it is unclear what the conversion(s) are relative to.
Inadequate Written Description
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 1-22 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to plants, plant parts, and seeds of variety SVQF0500, and methods of using said plants and progeny of said plants.
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 pea variety (SVQF0500). So, the examiner will evaluate what is an adequate written description for a new pea 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 1 (Spec 9-12). 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).
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).
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, decided June 15, 2020). 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) 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 (Haun 645, right column and 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, 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 instant 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 cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar 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). 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).
In the transmittal letter that accompanied the information disclosure statement (IDS) received on Mar. 31, 2025, Applicant provided the following information: the instant pea line/variety is a substantially homozygous, proprietary line developed from the initial cross of the substantially homozygous, proprietary line 0767 and the substantially homozygous, proprietary line PRF57ASIILZAFASH, followed by pedigree selection until the F8 generation (Trans. Letter 1-2). The specification does not include the original parents or the breeding technique at all. There is no breeding information in the specification.
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. A Transmittal Letter is not part of the Specification and cannot provide the written description required to be in the Specification. Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
In addition, because of the indefiniteness discussed above in the rejection under 35 USC 112B, it is unclear what characteristics are required for a pea plant to be a member of “variety SVQF0500”, therefore they have not been adequately described. It would appear that changes in characteristics are allowed for locus/gene conversions, therefore, the traits in Table 1 are not actually required. The Applicant has not described or set forth the characteristic traits that are absolutely required for a plant to be a member of the variety; have not disclosed which traits could be relied upon to distinguish the instant variety from other pea varieties. In addition, it is unclear what the base genome is prior to having any gene conversions as well as being unclear how many conversions are allowed relative to the base genome, therefore, the underlying genetics required to be a member of “variety SVQF0500” are not clear. Given that the genus of plants encompassed by “variety SVQF0500” is not clearly described by characteristic traits (function) or by underlying genetics that are absolutely required (core structure), the genus is not adequately described to support the breadth of the claims.
Claims 11 and 12 are, specifically, further rejected for inadequate written description because they are directed to a pea plant which has had an additional transgene introduced. Transgenes can be introduced via locus conversion (Spec 17 ¶ 47). The current claim has no limit as to how many transgenes are introduced and therefore no limit as to how many loci could be converted. See, for comparison, claim 14 which is limited to a single locus conversion (emphasis added). This broadens the claimed pea plants even further and has not been adequately described.
Claims 20-22 are, specifically, further rejected for inadequate written description because claim 20 is directed to a method of determining the genotype of the plant of claim 1 or a progeny plant thereof, or a part thereof. Progeny of pea variety SVQF0500 are a large genus of plants because there is no limit as to how many generations removed a progeny can be. Therefore, this claim is inclusive of methods that utilize nucleic acids from parts of progeny plants that are distally related and would not have retained the genome or traits of the instant variety. Applicant has not described the full breadth of this genus.
Lack of Enablement
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 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to seeds and plants of pea variety SVQF0500 or plants and plant parts derived from said variety, and methods that utilize said variety. Since the plant is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of the variety is considered sufficient to ensure public availability for most plant species. It is noted that Applicant states that a deposit of seeds has been made (Spec 29 ¶ 101) but they did not expressly state that all restrictions to public availability for the deposit will be irrevocably removed upon the issuance of a patent.
(a) If a deposit is ACCEPTED under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a 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 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) 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 effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
Claim Rejections - 35 USC § 101
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.
Claims 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claim(s) recite(s) a method of determining the genotype of a plant of pea variety SVQF0500 or a progeny plant thereof, or a part thereof, the method comprising detecting at least a first polymorphism in a sample of nucleic acids from said plant or part thereof. This is a product of nature that is used in a routine, conventional activity and claimed at a high level of generality. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because “a progeny plant” can be distally related to the claimed variety, and therefore, the progeny plant could be completely indistinguishable from a non-cultivated wild or landrace pea plant (product of nature). The method of detecting a polymorphism in a sample of nucleic acids from a wild or landrace pea plant does not amount to “significantly more” because those method steps are completely routine in the art. See, for example, MPEP 2106.05 I A and MPEP 2106.05(d) II.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s)20-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tar’an et al. (Genome (2005) Vol. 48; abstract only).
The claims are directed to a method of determining the genotype of a plant of pea variety SVQF0500 or a progeny plant thereof, or a part thereof, the method comprising detecting at least a first polymorphism in a sample of nucleic acids from said plant or part thereof; including wherein the detecting comprising DNA sequencing or genetic marker analysis, and including wherein the results are stored on a computer readable medium or transmitting the results of the detecting.
Tar’an teaches the use of random amplified polymorphic DNA, simple sequence repeat, and inter-simple sequence repeat markers to estimate the genetic relations among 65 pea varieties and 21 wild accessions (Tar’an abstract). This involved detecting polymorphisms in nucleic acid from these plants. Tar’an teaches arithmetic analysis over the marker results (Id.) which necessarily involved genetic marker analysis and transmitting the results of the detecting as well as using a computer for the analysis.
As, discussed above in the rejection under 35 USC 101, the claim broadly allows for the nucleic acids to come from progeny plants or parts of progeny plants, and these progeny plants can be distally related to the instant pea variety because there is no limit as to how many generations removed such progeny can be. For this reason, the nucleic acids used by Tar’an are indistinguishable from the broad genus of nucleic acids encompassed by the instant claims.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-22 is/are rejected under 35 U.S.C. 103 as obvious over Plouy, A. J. (US Patent US 9,795,101 B1; issued on Oct. 24, 2017).
The claim language is nearly identical between the issued patent and the instant claims. The limitations map as follows:
instant claim Plouy claim
1 2
2 1
3 3
4 5
5 6
6 8
7 16
8 18
9 19
10 21
11 22
12 22
13 col 2, lines 26-35
14 19
15 col 2, lines 26-35
16 14-15
17 15
18 15
19 24
20 cols 12-13 (molecular markers)
21 cols 12-13 (molecular markers)
22 cols 12-13 (molecular markers)
The Examiner takes official notice that the traits recited in claims 13 and 15 were well-known and routinely used at the time the instant application was filed. Because Plouy clearly anticipates and contemplates using molecular markers, which were also well-known and routing used at the time the instant application was filed, this would have inherently involved detecting a polymorphism in a sample of nucleic acids from said plant as well as performing genetic marker analysis. The step of storing the results on a computer readable medium or transmitting the results of detecting would have also been inherently involved in using molecular markers.
Because the claim language is so similar, the only real difference between Plouy and the instant application is the name of the pea variety/line. Plouy teaches pea line SV1391QH which share the vast majority of the qualitative traits with the instant pea line (Plouy, cols. 5-8 Table 1; Spec 9-12 Table 1). The quantitative traits are very close, and because the numeric values have not been given any standard deviations, and these values can be influenced by growth conditions, these small differences cannot be relied upon to distinguish the varieties unless they are grown side by side and shown to have a statistically significant difference. Furthermore, the instant claims allow for locus conversions that can alter characteristics of the line/variety, therefore, the exact traits in Table 1 are not required for the instant claims.
Because the Examiner is unable to determine if there are any differences between the two pea lines that are actually required by the instant claims, the Examiner cannot complete the Deere analysis for the differences. However, if Applicant can demonstrate a significant difference and amends the claims to require the difference, then the difference would need to be a non-obvious difference.
Furthermore, the instant specification does not provide a breeding history for how the instant pea line was developed. Comparing the names of the parent plants that were provided in the instant application in the Transmittal Letter received on Mar. 31, 2025, to the names of the parent plants utilized by Plouy (Plouy col 5, lines 38-40), it appears that different germplasm was utilized in the breeding programs, therefore, it is presumed there are at least some genetic differences between the two varieties.
For these reasons, the instant claims are obvious over the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-22 are Rejected Over US Patent No. 9,795,101 B1
Claims 1-22 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of prior U.S. Patent No. 9,795,101. See rejection under 35 USC 103, above, for mapping of limitations.
Duplicate Claims
Applicant is advised that should claim 11 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663