DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first-inventor-to-file provisions of the AIA .
Status
1. Claims 1-20 as filed on 4 June 2024 were examined and rejected in an Office action posted on 13 January 2026. Applicant responded on 5 May 2026 cancelling several claims. Applicant also filed a declaration from the inventor regarding the ancestry of the claimed maize plants. Claims 1, 5-12 and 16-20 are examined herein.
Examiner’s Notes
Citations to Applicant’s specification are abbreviated herein “Spec.”
2. In the January Office action there was considerable discussion of Munsell codes in the phenotypic tables. Applicant responded with amendments and discussion. Applicant referenced a website but reference to a website for essential material in understanding a patent application is not permissible.
One could also argue that the reference to a website is just for convenience and not necessarily essential matter.
This discussion is somewhat moot. Part of the reason for the discussion in the prior Office action was to document how the phenotypes were interpreted and thus how the application was examined. Use of Munsell codes is unusual in the maize patent art as discussed in the prior Office action.
Specification
3. The specification is objected to because of the following informalities.
On page 47, Applicant discusses the deposits. It identifies the ATCC as the depository but provides a PO Box for an address. The MPEP does not mention a mailing address, it requires the address. The address of the ATCC appears to be 10801 University Blvd, Manassas, VA. 20110.
Appropriate correction is requested.
Withdrawal of Objections and Rejections
4. The rejection of claims 2, 3, 4, and 13 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 is moot in view of the cancellation of the claims.
5. The rejection of claims 10 and 11 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the written description requirement as stated in the first line of the first paragraph of the rejection on page 9 is withdrawn The presence of “10” and “11” in that line appears to have been a mistake.
6. The rejection of claim 16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of Applicant’s amendments to the claim.
7. The rejection of claims 14, 15, and 19 under 35 USC 112(b) are rendered moot in view of the claims’ cancellation.
8. Any other rejection or objection applying to a cancelled claim is rendered moot in view of the claim’s cancellation.
35 USC § 112(a) based Claim Rejections
The following is a quotation of 35 U.S.C. 112(a):
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.
The Enablement Requirement of 35 USC 112(a) (Deposit)
9. Claims 1, 5-12 and 16-20 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 requires plants asserted by Applicant to be novel, the variety a5000.
Since this 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 seeds. 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 thus it is not apparent if the plant is readily available to the public with respect to this application. The specification does not teach such a process. Therefore Applicant must deposit seeds to comply with 35 USC 112(a). If a deposit is made, the deposit must be accepted under the terms of the Budapest Treaty or the results or a viability test must be provided.
Although on page 47 Applicant states that “including providing an indication of the viability of the sample, or will do so prior to the issuance of a patent based on this application” no such indication appears to have been received.
All claims require a perfected deposit to be considered patentable.
35 USC § 112(b)-Based Claim Rejections
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.
10. Claims 1, 5-12 and 16-20 are rejected under35 U.S.C. 112(b) or35 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.
All claims are rejected under 112(b) because they recite the limitation "A5000," "A511V," and "A513D" and/or a reference to a non-perfected deposits. Since the deposit has not been perfected the meaning of any of these limitations is uncertain and each creates ambiguity in the claims and thus renders the claims indefinite. The terms are not well known and generally accepted in the art, and the use of either of these terms does not carry art-recognized limitations defining the specific characteristics or essential characteristics that are associated with these denominations. In addition, the names appear to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of a maize plant that encompasses all of its traits except by deposit. Thus the terms in question lack a general art-accepted meaning and Applicant does not explicitly or adequately define the terms the terms in the specification.
Furthermore, the meaning of for example "A5000" could arbitrarily change to designate something different during the lifetime of a patent. Thus, one's ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F.2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970).
Perfecting the deposit will obviate the rejection with respect to the meaning of the terms in question.
Dependent claims are included in these rejections because none provide limitations obviating this rejection.
35 USC § 112(b)-Based Claim Rejections
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.
11. Claims 1, 5-12 and 16-20 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.
The claims are rejected because they reference a non-perfected deposit.
Until the deposit is perfected, the meaning of either of the limitations and thus the claims is uncertain and each creates ambiguity in the claims and thus renders the claims indefinite. The terms are not well known and generally accepted in the art, and the use of either of these terms by themselves does not carry art-recognized limitations defining the specific characteristics or essential characteristics that are associated with this denomination. In addition, the names appear to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of a maize plant that fully describes all of the traits except by deposit. Thus the terms in question lack a general art-accepted meaning and Applicant does not explicitly define, and cannot do so without a deposit, the terms in the specification.
Furthermore, the meaning of for example “A5000” could arbitrarily change to designate something different during the lifetime of a patent. Thus, one's ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F.2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970).
Dependent claims are included in these rejections because none provide limitations obviating this rejection.
Applicant did affirm the irrevocably release of the deposited seeds in the first paragraph of page 13..
Applicant amended the claims and specification to recite deposit numbers but failed to provide documentation that the deposits were accepted under the Budapest Treaty to provide documentation of a successful viability test. (3rd full para. p. 8)
The specification states that the deposit was to be made “according” to the Budapest Treaty but that is an indication of intent but not results.
The specification also states that “including providing an indication of the viability of the sample, or will do so prior to the issuance of a patent based on this application (p. 47) but no such proof appears to have been received.
Therefore the deposit is not perfected.
The Written Description Requirement of 35 USC 112(a)
12. Claims 19 and 20 remain 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.
Claim 19 (and 20) are included because claim 19 merely reads on a processed corn product without any limitation tying it to the claimed maize variety.
Further, as discussed above, Moore teaches that the commercial maize gene pool is shallow. Moore (cited in previous Office action).
These claims encompasses a vast genus of maize plants.
Thus the rejected claims encompass a large, unknowable genus.
Thus these claims are "reach through" claims in which the Applicant has potentially described a starting material, the deposited seeds, but also encompasses further changes, however, they have not described the resulting product, and the genus of products that can be produced by the recited starting materials is so large that one of skill in the art is not able to envision the members of the genus. See e.g. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004).
See also Vas-Gath Inc. v. Mahurkar, 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 [or her] 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.” Vas-Gath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991 ). Therefore, in the instant application, the disclosure of a claimed maize variety by deposit of its parents (to be perfected), does not provide adequate written description for the claimed genus of plants. The specification fails to describe the fully array of plants comprising the genus of transgenes, added traits and/or locus conversions encompassed by the claims. The specification fails to provide an adequate written description to support the breadth of the claims, Applicant has not demonstrated possession to one of skill in the art of the instant invention as broadly as claimed at the time of filing.
In the instant application, a practitioner would not be able to determine if any particular corn product obtained from a maize plant part is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
Applicant’s Response
On page 13 of the response Applicant stated that claims 19 and 20 were cancelled. They were not.
Therefore the rejection is maintained.
Written Description / Specification
13. Claims 1, 5-12 and 16-20 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.
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 (examiner). MPEP 2163.04 states that “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 maize variety, the A5000 hybrid variety. Below is a consideration of what constitutes an adequate written description for such a variety. In reviewing this question of fact, an evaluation is conducted in view of the corresponding art in the public domain. The review below suggests that the minimum requirements for an adequate description of a new plant variety is a trait table of phenotypes and genetic information. The breeding history usually provides the genetic information. In reviewing applicant’s specification there is a phenotypic description in Table 2 (pp. 44-47 after amendments).
However, there is no accompanying breeding history in the specification for the claimed variety other than the deposited seeds together with their designations, A511V and A513D. No breeding history is provided for either parent. Further, both parents appear to be unknown in the art.
,. Because the specification lacks a breeding history but that breeding history is arguably part of the minimum description of the claimed plant variety because there is no indication of the genetics that gave rise to the trait table.
the 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.
Offered as a persuasive argument, in a different section of the MPEP, with regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
Also as a persuasive argument, 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,” USDA (2023) https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023).
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 (2017) Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention (6 April 2017), see UPOV EDV Explanatory Paragraphs 14, 20 30 (V)) (pp. 7-11).
Recently, the USPTO’s Board’s considered breeding history information when determining the patentability of a new plant variety in applications before it. See Ex Parte C (USPQ 2d 1492 (1992)
and the 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.
Thus, in Ex Parte C and Ex Parte McGowan, a trait table was held insufficient to differentiate varieties by just on the basis of the phenotypes.
Additionally, the art teaches that intracultivar heterogeneity exists in crop species. Haun et al. (2011) teaches that the common assumption that elite cultivars are composed of relatively homogenous genetic pools is false. Haun et al. (2011) Plant Physiol 155:645-55, 645, left col. 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 (Id., 645, right col. and p. 646, left col.). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. Großkinsky et al.(2015) J Exp Bot 66(11):5429-40, 5430, left col., 1st full para., and right col., 2nd full para.). 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. Thus, the Office meets its 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, the legal authority relied upon is 35 USC 112(a). The citations support the finding of fact herein that a breeding history is necessary for adequate description of a claimed plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and helps with potential infringement analysis.
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 § 2411.05 sets forth the requirements for the content of the specification with respect to a deposited biological material.
Specifically, the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited biological material sufficient to specifically identify it and to permit examination. The description also 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.
Thus the breeding history aids in the resolution of patent examination as well as 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 potential infringement analysis with plants already patented as well as other plants in the prior art. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve potential 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. None of the individual phenotypes is unique even if the current combination is arguably unique.
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 amend the specification and/or drawings to provide the breeding history used to develop the instant variety. 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).
Applicant’s Response
Applicant traverses this rejection beginning on the bottom of page 13 through the top of page 14.
Applicant cites to the holding of Ex Parte C (Ex Parte C, 27 USPQ2d 1492 (BPAI 1992)) providing citation to “page 7” (perhaps 27 UPQ2d at 1500?).
However, the holding of Ex Parte C is distinguishable from the instant application on the fact pattern. The decision states that the “specification names the parent plants used to obtain the claimed cross.” 27 USPQ2d at 1495. Here, the specification is silent.
Applicant discusses Ex Parte McGowen (p. 14, top), Applicant points out that the rejection was under 35 USC 103.
In any case, in 14/996,093 provides the breeding history, see U.S. Patent Publication No. 2016/0249543, page 2.
Further,
“[T]he hallmark of written description is disclosure. Thus, "possession as shown in the disclosure" is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art."
Ariad Pharmaceuticals, Inc. V. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc)(no citation for internal quote).
Therefore Applicant’s argument was fully considered but is not persuasive.
The declaration by Dhyaneswaran Palanichamy is informative and, for example, allows locating the U.S. Patent Publication No. 2009/0291190 A1 as sharing a parent. However the declaration also distinguishes the PP79702 maize of Nagle et al.
Conclusion
No claim is allowed.
Allowable Subject Matter
The analysis of allowable and claimed subject matter as set forth in the prior Office action is unchanged.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL T BOGGS whose telephone number is (571)272-2805. The examiner can normally be reached Monday - Friday, 0800 to 1830 Mtn.
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/RUSSELL T BOGGS/ Examiner, Art Unit 1663
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