DETAILED ACTION
Claims 1-19 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Applicant is advised that should claim 4 be found allowable, claim 19 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).
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-19 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 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.
The claims all require seed of cultivar PennHFD.
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.
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.
If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
If the deposit of these seeds is made under the terms of the Budapest Treaty, then the deposit must be accepted under the Budapest Treaty and an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, must be made stating that the seeds 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.
If the deposit is not made and/or accepted under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, 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; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Claims 1-19 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 that 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.
A. 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 (i.e., the examiner). MPEP 2163.04 emphasizes this: “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 corn cultivar, PennHFD. In reviewing the question of fact of what is an adequate written description for a new corn cultivar, the examiner analyzed how plant varieties/cultivars 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).
The specification does not provide a phenotypic description of corn cultivar PennHFD and does not provide its breeding history. Applicant only provides a deposit number for it. However, phenotypic and parental (genetic) information and a deposit are all necessary parts of the description of a corn plant.
A plant described only by a deposit cannot be examined; the patent office does not have the facilities to grow up the claimed plant to determine its phenotype and do a genetic analysis on the claimed plant and plants with the same phenotype or a phenotype that makes obvious the claimed plant to see if the claimed plant is genetically related to the prior art plant.
There are over 10,000 patents on corn varieties and cultivars and thousands of patent applications that have been published but not yet issued. If these 10,000+ corn plants were only described by deposit, one needing to know the phenotype and genotype of any or all of the plants, as would a corn breeder, would need to grow each up to evaluate phenotype and perform a genetic analysis to evaluate genotype. Performing a phenotypic and genetic analysis on 10,000+ corn plants would be an undue burden on each corn breeder. It would also be a burden on the patent holder, as the deposited seed would rapidly be depleted and would need frequent replacement. Lastly, as deposits do not need to be maintained into perpetuity, the genetic information provided therein would no longer be available if there is a 5-year gap after the last request, shutting later breeders out of the information therein. Words describing the phenotype and parents of a corn plant do not shut future inventors out of a description of a prior art corn plant.
Numerous corn phenotypic traits are affected by the environmental conditions under which a plant is grown, and.
Because the phenotypic description of corn cultivar PennHFD was not provided in the application as filed, Applicant must only amend the specification to provide phenotypic traits that are not affected by the environmental conditions under which a plant is grown.
Appendix A compares the descriptions of 1351729 in US 7,473,826 and US 9,313,970, of 94INKI1A in US 7,872,183, US 8,035,006 and US 8,324,476, and of 1285291 in US 7,211,717 and US 8,969,677. The characteristics in bold are those that differ in the descriptions of at least one corn variety; these characteristics are those that are affected by the environmental conditions under which a plant is grown. The characteristics not in bold are those upon which this determination was made; these are brace root coloration, internode direction, anther color, presence of a glume band, ear shape, husk bract length, fresh and dry husk colors, endosperm type, and endosperm color. If Applicant has additional phenotypic traits for PennHFD, they can be added to the specification if evidence that they are not affected by the environmental conditions under which a plant is grown is provided.
Because a breeding history is part of the minimum description of a plant cultivar, 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:
1. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
2. 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 I s 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, accessed 05/01/2023).
3. 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 Notes 14 and 30).
4. 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.
5. As seen above in Ex Parte C and Ex Parte McGowan, a trait table alone is insufficient to differentiate varieties. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al. (2011, Plant Physiol., 155:645-655) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false (pg 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 (pg 645, right column and pg 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar (Großkinsky et al., 2015, J. Exp. Bot., 66:5429-5440; see pg 5430, left column, ¶2, and right column, ¶3). 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, as 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 for 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, in this case, all names of both parents, is not known to the public, the public does not have all needed information 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 and well as its phenotypic traits that are not affected by the environmental conditions under which a plant is grown. 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).
B. The specification provides no information on the homozygosity of PennHFD. This portion of the rejection addresses the situation in which PennHFD is an F1 hybrid or otherwise has heterozygous loci.
Claim 5 is drawn to a corn seed produced by the corn plant of claim 2, i.e., on PennHFD.
When an inbred is crossed to itself, the progeny are all identical to the inbred because an inbred is homozygous at all loci. When an F1 hybrid or a plant that otherwise has heterozygous loci is crossed to itself or another plant, the gametes produced are all diverse, with chromosomes assorting differently in each gamete and crossing over occurring between chromosomes. Its progeny are all diverse, with each trait that is heterozygous in the parent plant segregating in the resulting progeny.
The specification fails to describe the structural features that distinguish seed produced by PennHFD from other corn seed. The specification fails to describe the common attributes that identify members of the genus.
Hence, Applicant has not described seed produced by PennHFD and the specification fails to provide an adequate written description of the claimed invention. Given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed plants and sed, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
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 the second paragraph of 35 U.S.C. 112:
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, 6, 8, 12-13 and 15-16 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claim 3 is indefinite in its recitation of “all of the physiological and morphological characteristics of the plant of claim 2” Since the specification describes no physiological and morphological characteristic of PennHFD (the plant of claim 2), much less all of them, it is unclear what the he physiological and morphological characteristics of the plant of claim 2 are.
Regarding claim 6, the phrases “preferably” and “more preferably” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
Claim 8 is indefinite for its reference to Table 1. As claims are to be complete in themselves, reference to a Table is only permitted in exceptional circumstances. As the Table itself can be printed in a claim, this situation is not an exceptional circumstance as indicated in MPEP 2173.05(s).
The following phrases are relative ones that render the claims indefinite: “lower mortality rate” in claim 12; “lower incidence of intestinal lesion” in claim 13; “greater body weight gain” in claim 15; and “lower feed conversion ratio” in claim 16. The phrases are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Mortality rate, incidence of intestinal lesion, and feed conversion ratio can only be lower than these under another condition and body weight gain can only be greater under another condition. In none of the claims are any of these compared to anything else.
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 11-16 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth 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.
Claims 11 and 14 are drawn to methods of administering the corn seed of claim 1, or an animal feed made therefrom, to animals. When the method is one of administering an animal feed made from the corn seed, it does not use the corn seed of claim 1. While an animal feed made from the corn seed may comprise the corn seed, it may also only comprise its oil or only part of the seed. Thus, the claims fail to include all the limitations of the claim upon which they depend.
Claims 12 and 13 are drawn to the method of claim 11, wherein claims 12 and 13 recite an intended result, and claims 15 and 16 are drawn to the method of claim 14, wherein claims 15 and 16 recite an intended result.
As these results appear to be inherent features of administering the corn seed of claim 1, or an animal feed made therefrom, to animals, claims 12-13 and 15-16 fail to further limit the subject matter of the claims upon which they depend.
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.
Claim Rejections - 35 USC §§ 102, 103
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.
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.
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 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.
Claims 1-6 and 11-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wu et al (Front. Plant Sci., January 2021, 11:619598).
Wu et al describe maize lines B, C and D produced by backcrossing genes involved in the biosynthesis of anthocyanins, which are flavonoids, into maize inbred 4Co63 (pg 4, left column, paragraph 2; Figure 2). At least one these plants appears to be the instant PennHFD, as they have dark kernels (Figure 2) and appear to have all the physiological and morphological characteristics of PennHFD. These varieties were grown and self-pollinated and kernels (seed) was collected from the plants (pg 4, left column, paragraph 2).
Wu et al teach animal feed comprising the corn seed, in which the seed was 25% of the feed and administering the feed to mice (pg 9, right column, paragraph 2). The mice ate the feed comprising varieties B, C or D would have had a lower mortality rate had they not been sacrificed, appear to have had a lower incidence of intestinal lesions, and would have had a greater body weight gain and lower feed conversion ratio.
Claims 1-5 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by French (US 2018/0000035).
French teaches plants and seeds of corn line FAR614, which has a high concentration of anthocyanins, which are flavonoids (¶11, 42) and a hybrid produced from it (¶93-96, Table 4). These plants appear to be the instant PennHFD, as they have dark kernels (¶15) and appear to have all the physiological and morphological characteristics of PennHFD. French teaches corn seed produced on FAR614 (¶94) and using it for animal feed (¶39).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad 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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/Anne Kubelik/Primary Examiner, Art Unit 1663