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 .
Specification
The disclosure is objected to because of the following informalities: on page 65, in
paragraph [0234] of the deposit information, there is an accession number listed as “________”; additionally, there is no date of the deposit. The issue of a blank instead of an accession number is also found throughout the specification, as illustrated in at least paragraphs [0006], [0007], [0012], [0037], [0040], [0041], [0043], [0046], [0047], [0052], [0057] and [0061]. Appropriate correction of all instances of blanks instead of an accession number is required.
Claim Objections
Claims 1, 16 and 19 are objected to because of the following informalities:
In claim 1 "having" should be - - has - - in order for it to be grammatically correct.
Claim 16 recites "crossing the bean plant of claim 2 with itself" in parts (a), (b), and (d); and this is technically incorrect. A plant is either crossed with a different plant or else it is self-pollinated. See, for example, claim 11 which correctly recites "self-pollinating the bean plant of claim 2".
Claim 19 is missing a period at the end.
Appropriate correction 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 1-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-25 are drawn to a plant, plant part, or seed of bean plant variety designated HMC010522, and to methods of making and using this plant, plant part, or seed.
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 an adequate breeding history for the instantly claimed plant variety. Applicant specifically claims a new bean plant variety designated HMC0100522. A plant variety is defined by both its genetics (breeding history) and its traits. While the instant application sets forth the particular traits of the claimed plant variety in Table 1, the instant application is silent as to the particular breeding history used to produce the claimed plant variety. The instant application is incomplete as to the breeding history used to produce the bean plant variety designated HMC0100522 because its pedigree is not known in the art and is not provided in the specification. While the specification in paragraphs [0221]-[0023] does indicate that garden bean cultivar HMC010522 has superior characteristics and was developed from an initial cross that was made in Sun Prairie, Wisconsin, in a greenhouse, in the fall from two proprietary varieties, this breeding history is incomplete because it is not clear whether the proprietary lines are public or non-public lines. Further, it is not clear if the breeding history of the claimed variety comprises only a single crossing step of its parents, or if a backcrossing strategy was used, or if self-crossing steps to produce an inbred variety were involved, or if any other additional breeding methods were employed.
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, www.ams.usda.gov/services/pvpo/application-help/apply). 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, www.upov.int/edocs/expndocs/en/upov_exn_edv.pdf). 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. (Haun et al. The Composition and Origins of Genomic Variation among Individuals of the Soybean Reference Cultivar Williams 82. Plant Physiol. 2010 Nov 29;155(2):645–655, see 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. (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. (Großkinsky et al. Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap. J. Exp. Bot. 2015 Sep;66(18):5429-40. Epub 2015 Jul 10, see 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).
Claims 1-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the 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 seed of the bean plant variety HMC010522 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 seed is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit thereof. In the instant case the specification does not disclose a repeatable process to obtain the exact same seed in each occurrence, and it is not apparent if such seed is readily available to the public.
If a deposit is made 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 deposit has been accepted and that 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.
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:
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
For each deposit made pursuant to these regulations, the specification shall be amended to contain (see 37 CFR 1.809):
(1) The accession number for the deposit;
(2) The date of the deposit;
(3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
(4) The name and address of the depository.
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, 2, 4, 5, 14, 16-19, 22 and 23, AND ALL CLAIMS DEPENDNENT THEREON, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 1, 2, 4, 5, 14, 16-19, 22 and 23 are indefinite in the recitation of “HMC010522”, given that a name does not clearly identify the claimed bean plant variety and seed, and does not set forth the metes and bounds of the claimed invention. Since the name HMC010522 is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics which are associated with that denomination. In addition, the name appears to be arbitrary and the specific characteristics associated therewith could be modified. Amending the independent claims to recite the accession number, or the assurance that the claims will be so amended, would overcome the rejection.
Claims 1, 2, 4, 5, 14, 18, 19, 22 and 23, AND ALL CLAIMS DEPENDNENT THEREON, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 1, 2, 4, 5, 14, 18, 19, 22 and 23 are indefinite in the recitation of NCIMB No. ______”, because the accession number is missing. Amending the claims to recite the accession number, or the assurance that the claims will be so amended, would overcome the rejection.
Claim 10 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 10 is indefinite in the recitation of "The bean seed" in line 1. There is insufficient antecedent basis for this limitation in the claim because the method of claim 9 could produce an inbred or a hybrid, and if it produces a hybrid, the second parent plant could be any plant; therefore a bean seed produced by the method of claim 9 could be different bean seeds. In order to overcome the rejection, it is suggested that Applicant replace "The" with - - A - -.
Claims 20 and 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. Claims 20 and 22 are indefinite in the recitation of "improved shelf life", "delayed shelf life" and "improved nutritional quality”. It is unclear what is meant by these recitations, because they are not defined in the specification and can have variable meanings. For example, improved nutritional quality could indicate a change in amino acid composition, or a change in fatty acid composition, or a change in carbohydrate composition. Absent an explanation of what constitutes "improved shelf life", "delayed shelf life" and "improved nutritional quality”, claims 20 and 22 are indefinite.
Claim 23 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 23 is indefinite in the recitation of "essentially" all of the physiological and morphological characteristics of bean plant HMC010522”, because it is unclear which of the physiological and morphological characteristics of bean plant HMC010522 are essential and which are not. While the specification at paragraph [0076] indicates that
A plant having essentially all of the physiological and morphological characteristics means a plant having all of the physiological and morphological characteristics of a plant of the present disclosure, except for example, additional traits and/or mutations which do not materially affect the plant of the present disclosure, or, a desired characteristic(s), which can be indirectly obtained from another plant possessing at least one single locus conversion via a conventional breeding program (such as backcross breeding) or directly obtained by introduction of at least one single locus conversion via New Breeding Techniques.
the specification does not here or elsewhere explain which of the physiological and morphological characteristics of bean plant HMC010522 are essential and which are not under these circumstances. Accordingly claim 23 is indefinite.
Remarks
Claims 1-25 are provisionally deemed free of the prior art, given the failure of the prior art to teach or reasonably suggest bean plant with the specific combination of traits exhibited the exemplified bean plant variety HMC010522, or methods of its use. The closest prior art identified is Gehin (U.S. Patent No. 11,503,791, issued Nov. 22, 2022), who teaches a bean plant that differs from the exemplified bean plant variety in at least the following characteristics: distribution of sieve size at optimum maturity (columns 37-39).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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/CYNTHIA E COLLINS/ Primary Examiner, Art Unit 1662