Detailed Correspondence
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-32 are examined.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 12-13 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 12 and 13 are rejected because it is not clear what “other characteristics” is referring to. It is not clear which traits are being modified and which are being retained. The scope of “other” is not clear what it encompasses and what it does not. The base claim requires all of the morphological and physiological characteristics of the deposited variety. Thus, if modifications in one or more other characteristics are made, the claim is indefinite because it is not clear which other characteristics can be modified in a progeny of deposited lettuce variety 44-CL5535 RZ wherein the resulting plant would exhibit all morphological and physiological characteristics representative of the deposited variety.
Therefore, the metes and bounds of the claim limitations are indefinite.
Improper dependency
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.
Claims 12-15 and 32 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 12 requires a progeny plant of claim 10, wherein said progeny plant is modified in one or more other characteristics; the scope of the plant therefore does not include all of the limitations of the claim upon which it depends given that the modified plant would not encompass all of the morphological and physiological characteristics of the deposited variety.
Claims 13-15 require a lettuce plant of claims 11, 2 and 15, respectively, further comprising one or more modifications in claim 13 or a transgene in claims 14 and 15. The scope of the plants of claims 13-15 therefore do not include all of the limitations of the claims upon which they depend given that the modified plants would not encompass all of the morphological and physiological characteristics of the deposited variety.
Claim 32 is rejected because it appears to be identical in scope to claim 2, from which claim 32 depends. Claim 2 is drawn to a plant grown from the seed of claim 1. Claim 32 fails to further limit the subject matter of claim 2 because both claims only require a plant grown from the deposited seed.
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.
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 11-15 and 29 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to a plant comprising trait modifications relative to the plant represented by the deposited seed.
Applicant describes plants of variety 44-CL5535 RZ were made by an undisclosed cross of plants (Figure 2). Applicant describes that a lettuce plant designated 44-CL5535 RZ, representative seed of which has been deposited under NCIMB Accession No. 44380 [0042], exhibits a combination of traits provided in Figure 3. Applicant describes that lettuce variety 44-CL5535 RZ “is a uniform and stable line” [0047].
Claims 11-13 are drawn to a lettuce plant produced by a method that involves any number of crosses between 44-CL5535 RZ and distinct lettuce plants. Thus, this claim essentially reads on any lettuce plant exhibiting traits not described in the instant Specification. Claims 14-15 are drawn to a lettuce plant of the deposited variety further comprising a transgene. Claim 29 is drawn to a lettuce plant produced by the method of claim 28, wherein the plant comprises at least one new trait.
Plant breeding is highly unpredictable and even when crossing the same two parents, one will not necessarily produce the same products of the cross. Even when crossing two inbred parent plants, a breeder cannot predict the phenotype of a given cross until the cross is made given the complexity of inheritance and the multigenic pathways controlling the traits. If the parents are inbred lettuce plants, then the Applicant has only described a single species of the broad genus. The claim is not limited to the single working example provided in the specification.
Thus, plants having been produced by crossing 44-CL5535 RZ with a second, undisclosed plant have not been described. Given the scope of claims 11-13, progeny plants having all the traits of 44-CL5535 RZ, which is produced by self-pollinating a plant of the variety or by out-crossing a plant of the variety with a second, undescribed plant, the plant of claims 11-13 are clearly not limited to the described variety in the Specification. The claim encompasses progeny plants of any filial generation derived from 44-CL5535 RZ and that have been further modified to have any number of characteristics modified. The plant of claim 11 reads on not only F2 but higher filial generations having been further modified without resembling the starting variety genetically or phenotypically.
The same analysis applies to claim 29. While claim does require that the resultant plant otherwise comprise the morphological and physiological characteristics of lettuce variety 44-CL5535 RZ, the plant of claim 29 could still encompass an unlimited number of traits that are different from those of the deposited variety.
See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 U8PQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in its specification. In this case, there is no way that a practitioner would be able to determine if any particular soybean plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
These claims are “reach through” claims in which the Applicant has described a starting material and at least one method step, however, they have not described the resulting product, and the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
Applicant does not describe a representative number of plants modified in one or more other characteristics. Applicant only provides plants of lettuce variety 44-CL5535 RZ with characteristics listed in Figure 3. Plants encompassed by claims 11-15 and 29 include an undefined number of possible lettuce plants with varying genotypes and phenotypes which have not been described and which one of ordinary skill in the art would not have recognized Applicant to have been in possession of at the time of filing.
Missing Breeding History
Claims 1-32 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 claims 1-26, applicant claims a new lettuce plant variety and methods of producing the 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 seen in the specification. The instant application is 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” by the USDA (USDA PVP Requirements), Exhibit A). Additionally, the International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (See UPOV EDV Explanatory Notes 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen- Board Decision in Application 14/996,093). In both of these cases, there were many differences cited by the applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
Moreover, a specification devoid of a breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. Haun teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun, Page 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation. (See Haun, Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky, page 5430 left column 1st full paragraph and right column 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, applicant must amend the specification/drawing to provide the breeding history used to develop the instant variety or cultivar. When identifying the breeding history, applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety. For example, if applicant’s breeding history uses proprietary line names, applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information. If the breeding history encompasses a locus conversion or a backcrossing process, applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, applicant should provide the breeding history of the parent line as well (i.e. grandparents).
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant variety). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
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.
Claims 11-15 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Zee (US 11266090).
Claims 11-13 are drawn to a lettuce plant produced by a method that involves any number of crosses between 44-CL5535 RZ and distinct lettuce plants. Thus, this claim essentially reads on any lettuce plant exhibiting traits not described in the instant Specification.
Claims 14-15 are drawn to a lettuce plant of the deposited variety further comprising a transgene.
Claim 29 is drawn to a lettuce plant produced by the method of claim 28, wherein the plant comprises at least one new trait.
These claims include embodiments wherein 44-CL5535 RZ has an infinite number of modifications which do not require the characteristics of the deposited variety.
Van Zee discloses lettuce variety NUN 09166 LTL, which reads on the lettuce plant of claims 11-15 and 29. Van Zee anticipates claims 11-15 and 29 because these claims allow for an unlimited number of additional modifications.
Therefore, claims 11-15 and 29 are anticipated.
Closest prior art
Claims 1-10, 16-28 and 30-32 are free of the prior art. The closest prior art is van Zee (US 11266090), as applied to claims 11-15 and 29 under 35 USC 102(a)(1), above.
Conclusion
Claims 1-32 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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/DAVID R BYRNES/Examiner, Art Unit 1662