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 .
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action was withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7 January 2026 was entered.
Status
A restriction requirement was posted on 12 December 2024.
Applicant elected without traverse LJC75892 in the reply filed on 19 February 2025. Claims 1-20 as filed on 19 February 2025 were examined and rejected in an Office action posted 3 April 2025 Applicant responded on 3 July 2025. Claims 1-20 were examined and rejected in an Office action posted 10 July 25 (“Office Action”).. Applicant responded on 7 January 2026 by filing an RCE together with arguments and amendments. Applicant cancelled claim 7. Claims 1-6 and 8-20 are examined herein.
Applicant is reminded that upon the cancellation of claims, the inventorship should be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Examiner’s Notes
Citations to Applicant’s specification are abbreviated herein “Spec.”
Applicant and the Office agrees that Applicant has not perfected a deposit of seeds for the claimed maize variety.
Applicant also did not amend the specification to incorporate nay breeding history.
In Applicant’s response Applicant makes reference to a claimed soybean plant at the bottom of page 11. It appears to be a typographic error and it is assumed that Applicant meant “maize.” The prior occurrence of “soybean” on page 10 is appropriate since it is discussing Ex Parte C.
Withdrawal of Objections and Rejections
The objection to the title of the specification / disclosure is withdrawn in view of Applicant’s amendment.
The objections to claims 6 and 8 at the bottom of page 3 are withdrawn in view of Applicant’s amendments to the claims. Another objection to claim 8 remains due to the blank lines.
Any rejection of a cancelled claim is rendered moot by cancellation.
Specification
The disclosure is objected to because of the following informalities.
The specification is objected to because in the "DEPOSITS" section there are still blanks for the accession number and date. (Spec., p. 50).
This objection is maintained in the absence of a perfected deposit.
Appropriate correction is requested.
Claim Objections
Claims 1, 2, 6, 8 and 15 are objected to because of the following informalities.
Claims 1, 2, 8, and 15 have blank lines as a place-holder for the deposit number.
This objection is maintained in the absence of a perfected deposit.
Appropriate correction is requested.
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.
8. Claims 1-6 and 8-20 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 pre-AIA the applicant regards as the invention.
Claims 1, 2, 8, 15, 17 and 20 are rejected because they recite the limitation “LJC7589” in reference to maize plants. The deposit accession number in the claims is represented by a blank line.
Until the deposit is perfected, the meaning of the limitation“LJC7589” (as well as the blank line) is uncertain and creates ambiguity in the claims and thus renders the claims indefinite. The term is not well known and generally accepted in the art, and the use of this name by itself 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 encompasses all of its 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 “LJC7589” 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 this rejection because none provide limitations obviating this rejection.
This rejection is maintained in the absence of a deposit.
Claim Rejections - 35 USC § 112(a)
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)
Claims 1-6 and 8-20 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 inbred LJC7589.
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.
Applicant indicates that seeds will be deposited. Spec., p. 50.
Also, a statement, affidavit or declaration by Applicant, 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, is required to satisfy the deposit requirement made herein.
Dependent claims are included in this rejection because none provide limitations obviating this rejection.
This rejection is maintained in the absence of a perfected deposit.
Written Description / Specification
Claims 1-6 and 8-20 and the specification is/are rejected / objected to 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 under the following analysis. 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; or adequately described the claimed invention.
35 USC 112 (a) states that “The specification shall contain a written description of the invention.” In evaluating the written description requirement relative to the specification,, 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, LJC7589.
Below is a consideration of what might constitute an adequate written description for a variety/line. In reviewing this question of fact, an evaluation is conducted in view of the corresponding art in the public domain. This review concludes that generally the minimum requirements for an adequate description of a new plant line 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 1 (pp. 53-56).
However, there is no accompanying breeding history in the specification for the claimed LJC7589.
,. Because the specification lacks any breeding history but that breeding history is part of the minimum description of a maize variety, Applicant fails to fulfil the requirement of 35 USC 112(a) to provide a written description in the specification.
A reasonable basis for challenging the adequacy of written description is informed by a review of the following:
MPEP requires:
he 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))
This is also referenced in the Enzo v. Gen-Probe decision.
Furthermore, the Guidelines state that "'[o]nce the patent issues, the description must be sufficient to aid in the resolution of questions of infringement.'" Guidelines at 1107-08 n. 6 (quoting Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864, 34880 (Aug. 22, 1989) (codified at 37 C.F.R. pt. 800)).
Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 1022, 62 U.S.P.Q.2d 1289, 1295 (Fed. Cir. 2002).
Additionally, in a section of the MPEP dealing with Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage” in the specification.
Also, 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,” USDA (2023) https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023).
Thus a breeding history is considered material in the art.
In the BACKGROUND section, Applicant provides an excellent description of “plant breeding [as] a process to develop improved maize germplasm in an inbred or hybrid plant.” (beginning).
Specifically, in claim 1, applicant claims a new maize variety, LJC7589.
. Aside from the deposit, this maize variety is defined by both its traits as set forth in Table 1 and by its genetics, i.e., its breeding history). See, for example, Spec., p. 23, line 9 et seq.
In the instant application however, the specification only provides a phenotypic description of traits with absolutely no description of the underlying genetics. The instant specification is silent regarding the breeding history of the claimed variety.
In contrast, the specification is replete with discussion about how to change the genotype of the claimed variety (pp. 26-46) and how to use genetic markers (pp. 46-48), but other than what is inherent in the deposited seeds, Applicant provides no information regarding the genetics of the deposited seeds.
See 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 ).
None of the traits recited in Table 1 are unique to the claimed variety. For example, many other maize plants have green silk (e.g., Spec., p. 55). Their combination provides a fingerprint that may or may not be unique to this maize variety.
However a maize plant is not produced by selecting individual traits, it is produced by breeding. Thus, in part to protect an unintentional infringer, the breeding history is required as a summary of the genetics behind the invention.
Further, availability of the breeding history will expedite a full and through examination of the pending claims
To illustrate this point further, the breeding history features prominently in a recent decision by the Office’s Appeals Board.
In the McGowen decision, after analyzing the breeding history (p. 7 (btm)-8), the Board found the claimed plants to be obvious (p. 10). Ex Parte McGowen (PTAB 2020) (decision in appl. ser. no. 14/996,093). The decision provided extensive discussion of the traits. (para 5-8 & 12 pp. 4-5) These differences were cited by the applicant when comparing the prior art and the new plant variety. But the trait tables insufficient to overcome the finding of obviousness. See, for example, McGowen, paras. 6 & 8 (pp. 4-5). The decision, however, turned on the breeding history. (pp. 8 & 17).Because the breeding history was available, the phenotypic 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 the breeding history may be extremely useful 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 normal expected variation within a variety.
For example, the art teaches that intracultivar heterogeneity exists in crop species. Haun et al. teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun et al. (2011) Plant Physiol 155:645-55 (p. 645 left col.).
Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations maintain some degree of plant-to-plant variation. (See Id., 645 (rt. Col. & 646 (lt. col.).
In addition to genetic variation, environmental variation may induce phenotypic variation within a cultivar. See for example, the teachings of Großkinsky et al. regarding “phenome.” Großkinsky et al. (2015) J Exp Bot 66(18):5429–40 (p. 5430 (lt. col. 1st full para. & rt. col. the full para.)).
In view of this variability, the breeding history is essential and is the least burdensome way to Applicant to provide genetic information needed by the Office and the public to adequately describe a newly developed plant.
An application that does not clearly describe the breeding history does not provide an adequate written description of the invention and impairs a factual determination of the uniqueness of the claimed line.
To overcome this rejection, Applicant should amend the specification/drawing to provide the breeding history used to develop the instant line. 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.
To overcome this rejection, applicant should amend the specification/drawing 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 variety. If, for example, applicant’s breeding history uses proprietary line names, applicant should include in the specification all other names of the proprietary lines / varieties. This is particularly important in the case of publicly disclosed or patented lines / varieties. 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 describe 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 (See e.g. C.F.R. § 1.56 and MPEP § 2001). 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 If necessary, this information may be submitted as described in MPEP § 724 (e.g., trade secret, proprietary, and Protective Order).
This rejection is maintained.
Applicant provide the breeding history as an appendix, but did not incorporate it into the specification.
Applicant’s Arguments and Response
Applicant traverses the rejection. Response of Jan. 2026, pp. 6-13. Applicant’s arguments were fully considered but are not persuasive.
Applicant first cites to the Ariad decision. Response, p. 7. Applicant quotes the word “possession” and cites to page 1351.
In response: Indeed, the word “possession” does appear four times on that page. The last three occurrences are in the following passage.
The term "possession," however, has never been very enlightening. It implies that as long as one can produce records documenting a written description of a claimed invention, one can show possession. But the 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 bane),
In particular, “possession as shown in the disclosure" and “the four corners of the specification.” Clearly the Ariad decision supports the rejection.
The verb ‘facilitate’ does not appear in the decision and thus is merely Applicant’s interpretation and is not controlling.
Applicant’s emphasized point regarding “biological arts” on page 1350 of the decision is in reference to a functional limitation. Thus not relevant to the current rejection.
Applicant then turns to the lnari Agriculture, Inc., v Pioneer Hi-Bred decision. (Response, p. 8). lnari Agriculture, Inc., v Pioneer Hi-Bred Int’l. Inc., PGR2004-00020 (P.T.A.B. Sept. 24, 2024),
The bulk of the Inari decision is a hypothetical rejection under 35 USC 103 from pages 8 to 27. On page 30 (through page 33) the decision turns to the written description requirement of 35 USC 112(a).
In the last five lines of page 31, the Patent owner, Pioneer, is held to have provided the breeding history in the specification. In the second-to-last paragraph of page 33, the Petitioner Inari is held to acknowledge the same.
See also the bottom of column 37 in U.S. Patent No. 11,696,545 B1 (Ross) where the breeding history is taught. Thus whether or not the reeding history is required in the specification is entirely moot to this decision because it is there.
Applicant urges that requiring breeding history in the specification is somehow for convenience (near bottom of page 8). Applicant cites to the Ariad decision, but as discussed earlier, Ariad supports the rejection. Then Applicant holds up a “Rule 105 request” as a better way to examine cultivar patent applications.
In response, respectfully, there is no requirement in the MPEP to proceed through a ‘105 Request’ when examining cultivar applications. Thus Applicant’s position is not persuasive.
Applicant then states that the Enzo decision requires that a deposit provides adequate written description for an invention.
Applicant interprets Enzo too broadly. The Enzo decision held that written description requirement may be satisfied by a deposit. Enzo Biochem Inc. v. Gen-Probe Inc., 323 F.3d 956, 63 USPQ2d 1609, 1613 (Fed. Cir. 2002) (remanded). However, the Federal Circuit's Enzo decision remanded the case to the district court to resolve "genuine issues of material fact ... regarding satisfaction of the written description requirement" even in view of the deposit. Id., 323 F.3d at 960, 63 USPQ2d at 1610. Furthermore, the MPEP emphasizes that the Final Rule governing the deposit of biological materials requires that "[o]nce the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." MPEP § 2163(1) (quoting 54 Fed. Reg. 34,864, 34,880 (22 August 1989).
Returning to the Enzo decision, the case concerned US Patent 4,900,659 (“the '659 Patent") where the inventors deposited 6 strains of Neisseria meningitides, 6 strains of Neisseria gonorrhoeae, and 3 phagemid clones comprising DNA insert regions consisting of genomic DNA from Neisseria gonorrhoeae flanked by restriction enzyme sites from the phages (see the ‘659 Patent, cols. 20-21 and claims 1 & 4). The deposits were clones from single colonies (see col. 21 ). The genome of Neisseria meningitides is 2,272,351 bases. Tettelin et al. (2000) Sci 287:1809-15. The genome of maize is 2.4 Gb. Haberer et al (2005) Pl Phys 139(4)1612-24 (1st para.).
Even in Enzo decision, it was an open question as to whether the deposit of a significantly simpler genetic system satisfied the written description requirement. E.g., Enzo, 323 F.3d at 966, 63 USPQ2d 1615-16. It was remanded to the lower court. Id., 1617-18.
Applicant ends page 8 with an underlined conclusory statement which, at least right now, is not accurate since no deposit has been made.
Applicant begins page 9 by returning to Enzo and Inari which are discussed above.
In the third paragraph Applicant points out the difference between Plant Patents and Utility Patents.
The discussion of Plant Patents in the rejection very clearly offered it as persuasive but not controlling.
Further, Applicant includes “if the description is as complete as is reasonably possible.” Quoting from J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001), fn. 6 (citing to 35 U.S.C. and 35 U.S.C. §162).
“as reasonably possible”
Applicant provided the breeding history as an appendix to the response. How is it ‘unreasonable’ to require that it is placed in the specification?
Applicant, beginning at the bottom of page 9 and continuing through page 10 Applicant turns to the discussion of PVP regulations.
Again, the discussion was offered as an argument that is to persuade, but is not controlling. Nothing is improper about offering a persuasive argument, even if Applicant disagrees that it is persuasive.
Applicant then turns to Ex Parte C and spends the first long paragraph of page 10 discussing appellant’s position in the case. Then Applicant agrees with appellant.
Applicant quotes Ex Parte C that “there is nothing in the statute which commands [the breeding history’s ]inclusion in the specification. Response, p. 12 (top) quoting Ex Parte C 1496.
Ex parte C, 27 USPQ2d 1492, 1495-96 (Bd. Pat. App. & Int. 1992).
The statement in Ex Parte C is rather perplexing because the statute begins “The specification shall contain a written description of the invention, and of the manner and process of making and using it.”
Additionally, in Ex Parte C the patent was invalidated under 103 so to an extent, any discussion about requiring the breeding history is not on point.
Also, it’s axiomatic that the PTO does not have laboratories so that it is obviously impossible for an examiner to obtain a genetic analysis of the deposited seeds. Further, no seeds have been deposited.
Further, nothing suggests that the breeding history is not material. In Inari v. Pioneer both parties concede that the breeding history is in the specification. Even in the response, Applicant does not argue the breeding history is material, Applicant merely insists that Applicant should not be required to put it in the specification. But that argument does not make it any less material..
Applicant briefly touches on Ex Parte McGowen (p. 12) but here points out that since the case was decided under 35 USC 103, then a discussion of the written description requirement s is moot.
The same argument can be made, and was made above, regarding Ex Parte C. Decided under 35 USC 103, therefore statements about the written description requiremen in the decision are a side issue to the holding.
Applicant returns to a request for information under 37 CFR 105 as Applicant’s preferred way to proceed. (p. 12 through 13).
Such a request is not mandated by statute or by the MPEP. Applicant points to a court decision that is permissive for such a request but the court did not require such a request.
Therefore Applicant’s argument fails to persuade.
Second Examiner’s Note
The analysis of allowable subject matter on page 13 of the 3 April 2025 Office action is maintained.
It is also accepted practice to proceed to a Notice of Allowability without a perfected deposit. But the deposit must be perfected before the patent issues.
Conclusion
No claim is allowed.
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