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 1-24 are pending and examined on their merit herein.
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.
Claim 24 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 24 is directed to a method. The claims recite series of steps and, therefore, are directed to a process. Therefore, the claims fall within at least one statutory category. (Step 1: YES).
The method comprises the steps of detecting a polymorphism by comparing samples of nucleic acids from one plant to another.
Under the directive of Broadest Reasonable Interpretation, this steps—detecting and comparing-- fall into the “mental process” grouping of abstract ideas because the detecting and comparing process can be practically performed in the human mind, i.e., by observing and comparing data.
The claims further implies a law of nature because it silently invokes the naturally occurring relationship between a plant’s genotype (polymorphisms in the nucleic acids) and phenotype. Therefore, the claims are directed to the judicial exception because the limitation of obtaining a sample of nucleic acids is merely data gathering. The limitation is insignificant extra-solution activity. (Step 2A: Yes)
This judicial exception is not integrated into a practical application because “Analyzing DNA to provide sequence information or to detect allelic variants” has been recognized by the courts as a routine laboratory technique. See MPEP 2106.05(d), subsection II. This limitation therefore remains insignificant extra-solution activity and does not amount to significantly more. Even when considered in combination, these additional elements represent mere instructions to apply an exception and insignificant extra-solution activity, which cannot provide an inventive concept. (Step 2B: No.)
Therefore, claim 24 does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Therefore, claim 24 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim Rejections - 35 USC § 112
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 15 is 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.
Claim 15 is drawn to a seed produced by “the method of claim 12”. However, claim 12 does not recite any method. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of examination, claims 15-16 are interpreted to be directed to seeds produced by the methods of claims 13-14, respectively. It should be noted that such treatment does not relieve Applicants of the responsibility of responding to this rejection. Moreover, if the intended meaning of the claim is different than that posited by the Examiner, additional 35 U.S.C. § 112 and prior art rejections may be readily applied in a subsequent office action.
Claim Rejections - 35 USC § 112
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.
Written description
Claims 11-12, 15-16 and 19 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 claims contain 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.
Claims 11-12 are drawn to the seed and plant produced by the method of claim 10, which is a method crossing a male parent wild rocket plant with a wild rocket parent plant and harvesting the resultant wild rocket seed, wherein either the male or female parent plant is the wild rocket plant of claim 2.
It is noted that claim 10 does not specify the number of crossings and claims 11-12 do not specify the filial generation. Thus, the claimed progeny plant reads higher filial generation plants, or plants produced from more than one crosses.
As discussed above, Claims 15-16 are interpreted to be drawn to seed produced by the methods of claim 13 or 14, respectively, both comprising crossing a plant of wild rocket variety 89-WR012 RZ with another plant. Claim 14 further specifies repeating the crossing (with a second plant) an additional 3-10 generations. Thus, the claimed progeny plant reads higher filial generation plants, or plants produced from more than one crosses.
Claim 19 is drawn to wild rocket plant produced by the method of claim 18, which is a method comprising introducing a mutation or transgene into a plant of wild rocket variety 89-WR012 RZ. The claims do not limit the number of transgenes may be introduced via breeding or transformation. Thus, the claim broadly reads on derived plants that may comprise an undefined number of trait modifications.
In contrast to the broad scope of the claims above, Applicant describes wild rocket plant of variety 89-WR012 RZ were made by an undisclosed breeding history. Applicant describes some of the morphological and physiological traits of the wild rocket plant of variety 89-WR012 RZ, provided in Fig. 3.
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 --or mutating or transforming-- wild rocket plant of variety 89-WR012 RZ-- with a second, undisclosed plant have not been described. The plants of the claims encompass higher filial generations having been further modified without resembling the starting variety genetically or phenotypically, or comprise 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 stensible 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 wild rocket plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
This claim is a “reach through” claim 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 wild rocket plant of variety 89-WR012 RZ with some characteristics listed in Fig. 4. Plants encompassed by the claims 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.
Written Description regarding Missing Breeding History
Claims 1-24 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 full breeding history for the instantly claimed plant variety. Specifically, in claim 1, applicant claims a new wild rocket plant variety. A plant variety is defined by both its genetics (breeding history) and its traits.
In the instant application, applicant only provided a description of the plant traits as seen in the specification (e.g., Fig. 3). The Specification states that “Fig. 2 provides a detailed description of the development of wild rocket variety 89-WR012 RZ”. However, the Specification does not disclose or describe the parental lines used for the initial cross to make the F1 plant. Therefore, 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 reference to 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).
Conclusion
No claims are allowed.
Claims 1-24 are deemed to be provisionally free of the prior art, given the failure of the prior art to teach or suggesting a wild rocket plant having all of the morphological and physiological characteristics of the claimed variety. It should be noted that this statement is based only on a comparison of the morphological and physiological characteristics as disclosed, against the prior art. This is statement is provisional because Applicant has not provided any information regarding the parental lineage or breeding methodology used to produce the claimed wild rocket variety. Without this information, a meaningful comparison of the genetic and phenotypic basis that would distinguish the claimed plant variety from prior art plants cannot be made. Thus, this statement will remain provisional until the necessary information requested under the written description rejection (see above) is received, corrections are made to the description, and a complete search of the prior art is can be completed.
The closest prior art is Carree (US 10765079 B2) which teaches a wild rocket variety 89-004 RZ, which shares many traits in common (or does not significantly differ) with instant rocket variety. However, the plants differ in at least: leaf division, and height at flowering.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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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WEIHUA . FAN
Examiner
Art Unit 1663
/WEIHUA FAN/Examiner, Art Unit 1663