DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
2. Claims 1-32 are pending.
3. Claims 1-32 are examined herein.
Claim Objections
4. In claim 7, the term “A hybrid” should be amended to recite --An F1 hybrid--, for clarify of the claimed subject matter. Appropriate correction is required.
Specification
5. The specification is objected to because on page 46 and 47, the deposit statement is missing the deposit number and the date of the deposit. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
6. 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.
7. Claims 1-32 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 pre-AIA the applicant regards as the invention.
In claims 1, 3, 5, 9, 21, 23, and 24, the maize variety name “KW4FP1815,” without the corresponding deposit information, renders the claims indefinite. The term “KW4FP1815” is not otherwise known in the art and one of ordinary skill in the art would not be apprised of its metes and bounds. At the same time, one of skill in the art would recognize that common names of plant varieties can change over time. Because claims 2, 4, 6-8, 10-20, 22, and 25-32 depend from claims 1, 9, or 21 and fail to obviate their indefiniteness, these claims are indefinite as well.
Claim Rejections - 35 USC § 112(a)
8. 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.
Deposit of Biological Material
9. 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 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 invention appears to employ novel corn plants. Since the plant 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 plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the plant. A deposit of 625 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant and it is not apparent if the plant is readily available to the public.
On pages 46-47 of the specificaiton, Applicant provides a statement indicating an intent to make the required deposit of the seeds of the claimed variety, under the terms of 37 C.F.R. 1.801-1.809, but the deposit does not appear to have been made, as no accession number or the date are supplied. It is noted that pursuant to MPEP 2409, where a statement is merely an indication that a deposit has been made (with no indication as to whether it has been accepted), there is no assurance that the requirements under 35 U.S.C. 112 have been satisfied. Given that in the instant case, there is no indication that the deposit has been accepted, the deposit requirement is not met.
(a) 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 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.
(b) 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:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) 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);
(iii) 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;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
See MPEP 2404.01: The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
Written Description
10. 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 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.
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 (1) 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(1) 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, 3, 5, 9, 21 and 23-24, applicant claims a new inbred corn line designated KW4FP1815. 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 silent or 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 (2023) pp. 1-3). Additionally, the (International Union for the Protection of New Varieties of Plants (UPOV) 2017 Explanatory Notes on Essentially Derived Varieties; pp. 1-13) 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) pp. 1-11; and Ex Parte McGowen- Board Decision in Application 14/996,093 (2019) pp. 1-22. 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 et al. Plant Physiology 2011, Vol. 155, pp. 645-655; on 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 et al. (2015) Vol. 66, no. 18; pp. 5429-5440; on 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).
11. Claims 12-17, 20, and 26 fail to comply with the written description requirement for the following additional reasons.
The claims are directed to a plant produced by introducing into maize inbred line KW4FP1815 one or more transgenes, including wherein the transgenes are introduced via breeding or genetic transformation.
Applicant describes the morphological and physiological characteristics of inbred corn line KW4FP1815, in Table 1.
Applicant does not describe the genus of corn plants produced by introducing “one or more transgenes” into inbred corn line KW4FP1815 by backcrossing or transformation.
The specification states that “the present disclosure provides transformed inbred corn line KW4FP1815 or parts thereof that have been transformed so that its genetic material contains one or more transgenes, preferably operably linked to one or more regulatory elements. Also, the disclosure provides methods for producing a corn plant containing in its genetic material one or more transgenes, preferably operably linked to one or more regulatory elements, by crossing transformed inbred corn line KW4FP1815 with either a second plant of another corn line, or a nontransformed corn plant of the inbred com line KW4FP1815, so that the genetic material of the progeny that results from the cross contains the transgene(s), preferably operably linked to one or more regulatory elements” (pages 4-5, paragraph 0015 of the specification).
Both, the above teaching of the specification and the language of claims 11 and 19 (reciting the methods used to obtain the product-by-process plants of the claims at issue) indicate that that the resultant plants can comprise any number of transgenes conferring the recited characteristics. At the same time, since the claims do not require that the resultant plant otherwise comprise all of the morphological or physiological characteristics of inbred corn line KW4FP1815, and thus be a member of the claimed variety, one would recognize that the resultant plants may comprise characteristics that are not limited to those recited, for example, in claims 11 or 19. Consequently, the genus of plants that fall within the scope of the claims will comprise maize plants that could differ from inbred KW4FP1815 by a number of morphological and physiological characteristics. Given the breadth and variability of that genus, the single described species is not sufficiently representative.
It is well-known in the art that the introduction of a trait via backcrossing could result in numerous additional traits introduces as a result of linkage drag. For example, Fehr teaches that a single backcross, on average, will yield a plant that has only 75% of the original genes (Fehr (ed.). in Principles of Cultivar Development, Vol. 1: Theory and Technique (1987) pp. 360-376; Table 28-2). Fehr also teaches that genes conferring traits that are completely different from those of the target variety could be linked to a locus conversion being introduced by backcrossing (Fehr, pg. 37). As a result, the genus of plants derived from inbred corn line KW4FP1815 by introducing a transgene conversion via backcrossing could have morphological and physiological characteristics that differ dramatically from those of said line. Applicant has failed to describe a representative number of plants thus produced. Applicant has described only corn line KW4FP1815 with the characteristics listed in Table 1. The plants of the claimed plants, however, would encompass an undefined number of maize plants with varying genotypes and phenotypes which have not been described and thus were not in Applicant's possession at the time of filing.
In addition, Applicant has not set forth a structure or structures common to the genus, such that one of ordinary skill in the art would recognize which maize plant belongs to the claimed genus and which one does not. This is particularly true given that the claims would encompass plants comprising genetic material that is not shared by the plants of the deposit.
See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 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 his specification. In this case, there is no way that a practitioner would be able to determine if any particular corn 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)).
Accordingly, the specification fails to provide adequate written description to support the genus of corn plants produced by introducing one or more transgenes into inbred corn line KW4FP1815.
Claim Rejections - 35 USC § 102
12. 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.
13. Claims 12-17, 20, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Couteau (US Patent No. 10,856,490, issued on December 8, 2020; filed on March 29, 2019).
Applicant claims a plant or seed produced by introducing one or more desired transgenes into corn line KW4FP1815; including wherein the transgene confers the traits recited in claims 13-17. The plants of claims 12-17, 20, and 26 are recite as products obtained by the processes of claims 11, 19, and 25. As set forth in the rejection under 35 U.S.C. 112(a) for lack of written description, above, the claims do not require that the resultant plants comprise any of the morphological and physiological characteristics of inbred corn line KW4FP1815. As a result, the claims are given their broadest reasonable interpretation as encompassing a genus that comprises plants that differ from corn line KW4FP1815 at a number of characteristics. It is noted that the patentability of a product does not depend on its method of production. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Couteau discloses an inbred corn line called KW4FP1815 that shares a number of characteristics with the claimed line (see Table 1 in col. 17-18). Couteau discloses a method of producing a corn plant by introducing one or more transgenes into said corn line, including there the transgene confers resistance to glyphosate or other herbicides; encodes a Bacillus thuringiensis protein; confers water stress tolerance; increased digestibility; or increased waxy starch or amylose starch metabolism. Couteau discloses a resultant plant or seed obtained using said methods (claims 10-16, 18, 19, 24, and 25). Given the above claim interpretation, the disclosure of Couteau anticipates the limitations of the instant claims 12-17, 20, and 26.
Conclusion
14. No claims are allowed.
15. Claims 1-11, 18, 19, 21-25 and 27-32 appear free from the prior art. However, a complete search of the prior art cannot be accomplished without the breeding history of the claimed corn line.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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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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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662