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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/01/2026 has been entered.
Claims 1-21 are pending and examined.
Claim Rejections - 35 USC § 112
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.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 is indefinite in the recitation of “essentially” all of the physiological and morphological characteristics of soybean line CL156938” because the specification fails to define the term, so it is unclear which physiological and morphological characteristics are considered “essentially all” or what percentage of the physiological and morphological characteristics of the soybean variety are “essentially all”. Further, since step (e ) is optional , step (d) does not to recite “essentially all”. Therefore, the metes and bounds of the claims are unclear.
Claim Rejections - 35 USC § 112, Written Description, Lack of Breeding History
Claims 1-21 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 rejection is repeated for the reasons of record as set forth in the last Office actions. Applicant’s arguments filed 05/01/2026 have been fully considered but are not deemed persuasive.
The rejection is maintained for the reasons set forth below.
The specification fails to demonstrate possession of the claimed invention.
The first paragraph of 35 U.S.C. 112(a) explicitly states
“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….”.
As the law clearly states, providing the breeding history and parental lines of the soybean line CL1561938 in the specification is NOT merely to “facilitate examination” or facilitate prior art searches but to comply with the statue 35 USC 112(a) by providing the structural description and the identity of the claimed soybean line and F1 progeny thereof, to show that Applicant’s possession of the claimed invention. Absent the breeding history and parental lines, the specification does not identify what the claimed soybean line and F1 progeny thereof are. The Office is not permitted to assume possession where the specification provides no structural information (e.g., pedigree, parental lines) and breeding methodology for the claimed soybean line and F1 progeny. A description and information that allow one to verify what the invention is, is a fundamental requirement.
The relationship between the written description and biological deposits was addressed in both the MPEP 2163 and controlling case law including Enzo Biochem, Inc. V. Gen-Probe Inc., 323 F.3d 956, 966, 63 USPQ2d 1609 (Fed. Cir. 2002) (en banc in part) and In re Lundak. The following is from the MPEP 2163
Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of certain biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 ("reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material"); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) ("The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted." Id. at 34,876. "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.) Such a deposit is not a substitute for a written description of the claimed invention. 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."
With Regard to Enzo, the court held that a deposit may support written description in cases where microorganism cannot otherwise be described. Enzo stands for the proposition that a deposit may support written description when the deposit supplies the only means to describe the invention. The instant case, however, is claiming a plant variety. Unlike microorganism, a plant variety is routinely described by breeding history and parental lines.
With regard to In re Lundak, it is noted that the court did not hold that a deposit satisfied written description, nor did it eliminate the requirement for structural description. Lundak held that deposits need not proceed filing.
Regarding PTAB 2024 (Inari v. Pioneer), it is noted that the cited PGR decision involved as to whether the challenger (not the applicant) had met its burden regarding indefiniteness. The PTAB 2024 didn’t involve as to whether the specification satisfied 112(a) when first filed.
Therefore, none of Enzo Biochem , Lundak, or PTAB 2024 appears to Applicant’s position regarding the relationship between written description and deposit.
Further, depositing seeds does not excuse or replace the requirement that the specification itself must describe the invention in sufficient detail to demonstrate possession. As explained below, a seed deposit is not a substitute for a structural description when the genus is broad, variable, or unpredictable, or when the claimed subject matter cannot be defined solely by phenotype.
As stated above, the instant specification fails to provide the breeding history of the claimed soybean variety as required by the law under first paragraph of 35 USC 112(a), that the "specification shall contain a written description of the invention....." Biological deposit of seeds would not indicate parents that were used to create the instantly claimed seed.
Applicant's attention is drawn to MPEP at 2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, "Written Description" Requirement [R-01.2024] under 3rd paragraph of item I (General principles governing compliance with the "written description" requirement for applications), which says:
Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) ("The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C.112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted." Id. at 34,876. "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.) Such a deposit is not a substitute for a written description of the claimed invention. 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.").
This means, 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. Without knowing the parents of the claimed soybean variety, one skilled in the art cannot conclude or establish the Applicant was in possession of the claimed invention.
While the deposit may satisfy enablement for reproducing the biological material, the written description is a separate requirement and is not automatically met by the act of depositing seeds. According to the MPEP 2163 and supporting case law (Ariad; Eli Lilli), written description requires:
(i) Applicants demonstrating possession of the claimed structure;
(ii) description by both function (or by phenotype alone) and structure (genotype).
(iii) a genus must be supported by a representative number of species or by identifying common structural features.
In the instant case, however, the claimed soybean plant variety CL1561938 is described solely by a deposit number and by a phenotypic trait table. The specification lacks breeding history, parental information or structural description of the genotype.
B) Providing the breeding history in the specification is required not only for the structural description of soybean line CL1561938, but also for the structural description of the F1 progeny and soybean line CL1561938 further comprising a single locus.
1) a full examination to sufficiently distinguish the claimed soybean line CL1561938 cannot be conducted without information about the breeding history and parental lines of the soybean line. The soybean line CL1561938 is a new variety according to the specification. A plant variety is defined by both its genetics (breeding history) and its phenotype. In the instant application, Applicant has only provided all the morphological and physiological characteristics (Table 1 and deposit of the seed). The instant application is silent as to the breeding history and parental lines used to produce the claimed variety. Further, the claims are not limited to the soybean plant/seed of soybean line CL1561938 but also encompass a plant of soybean line CL1561938 further comprising a single locus conversion, an F1 seed/plant, an F1 seed/plant having a heritable transgenic event, a desired trait or a locus conversion (see claims 7-9, 11-13, 15, 17 and 21).
2) The inclusion of the breeding history information in plant breeding discipline is NOT for convenience but a statutory requirement of the 35 USC 112(a).
The statute is clear:
35 U.S.C. § 112(a) (first paragraph)
"The specification shall contain a written description of the invention in such full,
clear, concise, and exact terms as to enable any person skilled in the art to... make and use the same."
As clearly outlined above, the law requires that under the first paragraph of 35 USC 112(a), and the first paragraph of pre-AIA 35 USC 112 require that the specification shall contain a written description of the invention…..”. This has not been done in the instant specification, however, because the breeding history and parent lines have not been disclosed for the soybean line CL1561938. The breeding history and the parent lines provide a description that allows a skilled artisan to verify what the invention is, and is a fundament requirement.
With regard to Applicant’s argument that breeding history is irrelevant or that plant patent /PVP/UPOV practices should not apply, it is noted that breeding history is required for the structural description of a plant variety. A plant variety is defined by both its genotype (structural origin) and its phenotype. Description of solely a phenotype is insufficient due to environment effects, known intracultivar variation, and the existence of closely related sister lines. This was evidenced by Haun et al (intracultivar variation), and Grobkinsky (phenotype variability due to environmental effects); while Ex Parte C and Ex Parte McGowen both show that breeding history is essential for distinguishing varieties and determining possession and obviousness. Applicant’s arguments, however, selectively quotes Ex Parte C but ignores the portion where the board stated “the examiner’s concern is that appellant’s specification does not serve to distinguish the invention from other things before known”. That is precisely the defect in the present specification: Without breeding history, the claimed soybean line cannot be structurally distinguished from the prior art soybean lines or their sister lines, nor can possession be established.
3) 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 infringement questions. For biological materials, including newly developed plant varieties, this necessarily includes structural information, not merely functional or phenotypic traits. Therefore, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
The limitations in the claims that require breeding history and parental lines for structural description are the “ soybean line CL1561938”, a plant and seed of soybean line CL1561938 further comprising a single locus conversion, an F1 seed/plant, an F1 seed/plant having a heritable transgenic event or having a desired trait or a locus conversion. Each of these plant and seed limitations are produced by breeding methodologies that employ with parental lines. Therefore, contrary to Applicant’s arguments, the listing of the parental lines in the specification for the soybean line CL1561938 is essential for the identification and possession of the claimed invention.
C. Inclusion of breeding history and parental lines in the specification of variety patent applications does not constitute substantive rule changes by the USPTO.
A breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a new developed plant variety, like the soybean line CL1561938. The requirement to include breeding history in the specification is NOT a rule change by the USPTO. The USPTO has been receiving plant variety applications with breeding history listed in the specification since at least 1999. Plant variety patent applications that matured to US patents have been listing breeding history and parent lines in the specification . Few examples are listed below :
- US 5, 920, 001 (issued on Jul 06, 1999) listed the breeding history and parental lines of soybean variety CX496C on column 9 of the specification.
-US 6,140,556 (issued on Oct 31, 2000) listed the breeding history and parental lines of the soybean variety CX414cRR on column 5 of the specification.
-US 7, 351,861 (issued on April 1, 2008) listed the breeding history and parental lines of the soybean variety 4812469 in the paragraph bridging columns 5 and 6 of the specification.
-US 7, 619, 139 (issued on Nov 17, 2009) listed the breeding history and parental lines of soybean variety D4572906 in columns 5-6 of the specification.
-US 8,003858 (issued Aug. 23, 2011) listed the breeding history and parental lines of soybean variety A1007964 on column 3 of the specification.
-US 8,822, 775 (issued on Sept 2, 2014) listed the breeding history and parental lines of soybean variety 95Y21 on Table 4 of the specification;
-US 9, 155, 271 (issued on Oct 13, 2015) listed the breeding history and parental lines of the soybean variety 01046887 on column 3 of the specification.
-US 9, 497, 914 (issued on Nov 22, 2016) listed the breeding history and parental lines of the soybean variety 01045730 on column 3 of the specification.
- US 10, 159, 205 (issued on Dec 25, 2018) listed the breeding history and parental lines of the soybean variety 01064633 on columns 3-4 of the specification.
-US 10. 349, 604 (issued on July 16, 2029) listed the breeding history and parental lines of the soybean variety 5PFBL54 on column 37 (Table 2) of the specification.
-US 11, 096,357 (issued on Aug. 24, 2021) listed the breeding history and parental lines of soybean variety 01073351 on column 4 of the specification.
-US 11, 864, 525 (issued on Jan 09, 2024) listed the breeding history and parental lines of soybean variety 5PSQC68 on column 37 of the specification.
-US 12, 004, 475 (issued on June 11, 2024) listed the breeding history and parental lines of soybean variety 01091767 on column 4 of the specification.
-US 12, 628, 780 (issued on May 19, 2026) listed the breeding history and parental lines of soybean variety 01073351 on column 4 of the specification
With regard to Applicant’s argument regarding the right to obtain a patent on otherwise patentable plant varieties while retaining the possibility of keeping the breeding the breeding history a trade secret, it is noted that the method of submitting trade secret, proprietary, and/or protective order materials is outlined in the MPEP 724.02 and was also outlined in the last office actions. It is unclear, however, when Applicant is agreeing to submit the breeding history information via Rule 105 information request, why not Applicant submit the same information in response to the written description rejection.
In summary:
The claimed invention is not adequately described because the specification does not demonstrate possession of the soybean variety CL1561938”, a plant and seed of soybean line CL1561938 further comprising a single locus conversion, an F1 seed/plant, an F1 seed/plant having a heritable transgenic event or having a desired trait or a locus conversion. Because the claimed plant and seed are produced by breeding methodologies that employ with parental lines, full breeding history and parental lines for at least the soybean variety CL1561938 are required to establish possession and allow a skilled artisan to identify the structural identity of the claimed plants and seed.
Contrary to Applicant’s arguments, an Applicant shows possession of the claimed invention by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention (MPEP 2163). In the instant application, because Applicant has not disclosed the breeding history, one of skilled in the art would not be able to know the genetic profile of parents from the deposited seeds of the claimed variety.
According to the MPEP 2163 and supporting case law (Ariad; Eli Lilli), written description requires:
(i) Applicants demonstrate possession of the claimed structure;
(ii) description by both function (or by phenotype alone) and structure (genotype).
(iii) a genus must be supported by a representative number of species or by identifying common structural features.
In the instant case, however, the claimed soybean plant variety CL1561938 is defined solely by a deposit number and by a phenotypic trait table. The specification contains no breeding history, parental information or structural description of the genotype.
Therefore, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention. Thus, the rejection is maintained.
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).
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662
Prosecution Insights