Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 23-25 are withdrawn.
Claims 1-22 are examined.
Election/Restrictions
Applicant’s election of claims 1-22 in the reply filed on 2/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 112(b)
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 3, 5 and 21 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.
In claim 3, it is unclear whether the recitation of “wherein the plant is a plant of said corn line SHY-6S21-6018LL” means (a) claim 3 is directed to an inbred plant of corn line SHY-6S21-6018LL, or (b) claim 3 is directed to a progeny plant of corn line SHY-6S21-6018LL, which is not further limiting. It is suggested “a plant” be amended to “an inbred plant”.
In claim 5, it is unclear whether the recitation of “wherein the seed is a seed of said corn line SHY-6S21-6018LL” means (a) claim 5 is directed to an inbred seed of corn line SHY-6S21-6018LL, or (b) claim 5 is directed to a progeny seed of corn line SHY-6S21-6018LL, which is not further limiting. It is suggested “a seed” be amended to “an inbred seed”.
In claim 21, the plant of step (a) cannot be produced from the seed of step (b) because the seed of step (b) is a progeny of the plant of step (a). It is suggested “for producing the plant according to step (a)” be deleted.
Correction or clarification is required.
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.
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.
Since the seed claimed 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 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 repeatable 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. It is noted that Applicant states the deposit has been made of corn line SHY-6S21-6018LL (Specification pages 37-38); however, there is no statement in the specification explicitly stating that the deposit has been accepted and that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made under the terms of the Budapest Treaty, then a statement, an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds has been deposited and accepted, and 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 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, an 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:
(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 in accordance with 37 CFR 1.808(a)(2);
(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 effective 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 inviable.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Written Description
Claims 8, 12 and 14-18 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 is drawn to a plant having all the physiological and morphological characteristics of a corn plant having a set of chromosomes of corn line SHY-6S21-6018LL but does not require to have the genetic component of inbred corn line SHY-6S21-6018LL. Therefore, claim 8 encompasses a genus of corn plants having unknown genetic components and the specification fails to describe a representative species of the claimed genus or provide genetic traits common to the members of the genus claimed. The only species described is the corn line SHY-6S21-6018LL itself.
Claims 12 and 14-18 are drawn to a genus corn plant produced by breeding a corn plant having a set of chromosomes of corn line SHY-6S21-6018LL as the recurrent parent or by introducing any number of transgenes conferring various traits or a single locus conversion into said corn plant; however, the morphological and physiological characteristics of the claimed plants are unknown because as known to one of skill in the art, backcrossing the corn plant having a set of chromosomes of corn line SHY-6S21-6018LL with a different unknown corn plant produces plants with a new phenotype. The plant is only described as having a desired trait and as produced from corn plant having a set of chromosomes of corn line SHY-6S21-6018LL after crossing with an unknown second corn plant. However, the plant does not necessarily retain all of the morphological and physiological characteristics of a corn plant having a set of chromosomes of corn line SHY-6S21-6018LL. Given the specification fails to describe even a single corn plant having a set of chromosomes of corn line SHY-6S21-6018LL and comprising a single locus conversion or a transgene, one of skill in the art cannot reliably predict the morphological and physiological characteristics of the members of the genus claimed. Therefore, since the claims do not recite the plant retains all of the morphological and physiological characteristics of corn line SHY-6S21-6018LL, the claimed plant is not adequately described.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed. See University of Rochester v. G.D. Searle & Co.: 68 USPG2d 1424, 1433 (DC WNY 2003) which teaches knowing the "starting point" is not enough; that is little more than a research plan. The court held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112.
Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Amending claim 8 to depend from claim 4 would obviate the rejection.
Amending claims 12 and 14 to recite, ---wherein the plant otherwise has all of the morphological and physiological characteristics of corn line SHY-6S21-6018LL -----, would obviate the rejection.
Missing Breeding History
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 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. 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 not provided a breeding history including the parent lines used to produce SHY-6S21-6018LL, their respective pedigrees, whether they have any other names which would be needed to confirm whether they have been used in the production of other plants and selection criteria used to produce the instantly claimed 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 (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.
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 should identify any and all names for the parental lines used 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).
Closest Prior Art
The closest prior art is sweet corn variety SYW-6SIDL159, taught by Hellewell (US 10743502). The variety of Hellewell shares many characteristics with the instantly claimed variety but is different in at least husk extension and ear taper. Therefore, the variety of Hellewell is distinct from the instantly claimed variety and is not an obvious variant.
Conclusion
Claims 1-22 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID R BYRNES/Examiner, Art Unit 1662