DETAILED ACTION
Claims 1-2 and 5-19 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The notice that should claim 4 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof is withdrawn in light of Applicant’s cancellation of the claim.
The rejection of claims 3, 6, 8, 12-13 and 15-16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 11-16 under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 1-6 and 11-19 under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wu et al (Front. Plant Sci., January 2021, 11:619598) is withdrawn in light of Applicant’s and the Declarations arguments regarding parentage.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 5-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 26 February 2026, as applied to claims 1-19. Applicant’s arguments filed 27 July 2026 have been fully considered but they are not persuasive.
The claims all require seed of cultivar PennHFD.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public.
The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
If the deposit of these seeds is made under the terms of the Budapest Treaty, then the deposit must be accepted under the Budapest Treaty and an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, must be made stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
If the deposit is not made and/or accepted under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Response to Arguments
Applicant urges that PennHFD has been deposited under the Budapest Treaty (response pg 7).
This is not found persuasive because Applicant must either make the statement that the deposit was accepted under the Budapest Treaty or provide evidence that it was so accepted.
Applicant urges that they made the required statement of viability and proper deposit under the Budapest Treaty on page 22, lines 11-20 of the specification as filed (response pg 7).
This is not found persuasive. Neither the specification as filed nor the specification as amended on 27 July 2026 have any indication that the deposit was made and accepted under the Budapest Treaty; the specification should be amdned to indicate such. Further, a statement that the deposit is viable is not sufficient. If a deposit is made under the Budapest Treaty, then Applicant must either assert that the deposit was accepted under the Budapest Treaty or must provide evidence that it was so accepted. If a deposit is made under US practice, then Applicant must provide evidence of viability.
Claims 1-2 and 5-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is modified from the rejection set forth in the Office action mailed 26 February 2026, as applied to claims 1-19 solely to remove portions no longer included in this rejection. Applicant’s arguments and the Chopra/Calvo Declaration, both filed 27 July 2026, have been fully considered but they are not persuasive.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (i.e., the examiner). MPEP 2163.04 emphasizes this: “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new corn cultivar, PennHFD. In reviewing the question of fact of what is an adequate written description for a new corn cultivar, the examiner analyzed how plant varieties/cultivars are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history).
The specification does not provide a phenotypic description of corn cultivar PennHFD. Applicant only provides a deposit number for it. However, phenotypic information and a deposit are all necessary parts of the description of a corn plant.
A plant described only by a deposit cannot be examined; the patent office does not have the facilities to grow up the claimed plant to determine its phenotype and do a genetic analysis on the claimed plant and plants with the same phenotype or a phenotype that makes obvious the claimed plant to see if the claimed plant is genetically related to the prior art plant.
There are over 10,000 patents on corn varieties and cultivars and thousands of patent applications that have been published but not yet issued. If these 10,000+ corn plants were only described by deposit, one needing to know the phenotype and genotype of any or all of the plants, as would a corn breeder, would need to grow each up to evaluate phenotype and perform a genetic analysis to evaluate genotype. Performing a phenotypic and genetic analysis on 10,000+ corn plants would be an undue burden on each corn breeder. It would also be a burden on the patent holder, as the deposited seed would rapidly be depleted and would need frequent replacement. Lastly, as deposits do not need to be maintained into perpetuity, the genetic information provided therein would no longer be available if there is a 5-year gap after the last request, shutting later breeders out of the information therein. Words describing the phenotype and parents of a corn plant do not shut future inventors out of a description of a prior art corn plant.
Numerous corn phenotypic traits are affected by the environmental conditions under which a plant is grown, and.
Because the phenotypic description of corn cultivar PennHFD was not provided in the application as filed, Applicant must only amend the specification to provide phenotypic traits that are not affected by the environmental conditions under which a plant is grown.
Appendix A compares the descriptions of 1351729 in US 7,473,826 and US 9,313,970, of 94INKI1A in US 7,872,183, US 8,035,006 and US 8,324,476, and of 1285291 in US 7,211,717 and US 8,969,677. The characteristics in bold are those that differ in the descriptions of at least one corn variety; these characteristics are those that are affected by the environmental conditions under which a plant is grown. The characteristics not in bold are those upon which this determination was made; these are brace root coloration, internode direction, anther color, presence of a glume band, ear shape, husk bract length, fresh and dry husk colors, endosperm type, and endosperm color. If Applicant has additional phenotypic traits for PennHFD, they can be added to the specification if evidence that they are not affected by the environmental conditions under which a plant is grown is provided.
To overcome this rejection, Applicant must amend the specification/drawing to provide the phenotypic traits for the instant cultivar that are not affected by the environmental conditions under which a plant is grown.
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).
Response to Arguments
Applicant urges that the biological deposit makes clear that the inventors "had possession" of the claimed subject matter (response pg 7).
This is not found persuasive. The deposit is necessary but not sufficient to describe the claimed variety and is not substitute for a written description of the claimed invention. A description of the morphological and physiological characteristics of PennHFD is also required.
See MPEP 2163 I:
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."). (emphasis added)
Applicant urges that the breeding history of PennHFD is described in the specification (response pg 8).
That portion of the previous rejection has been removed from the current rejection.
Applicant urges that the specification shows the phenotypic traits of PennHFD in FIG. 2, showing dark coloring in the vegetative parts of the plant and dark kernels, which indicate high levels of flavonoid accumulation in the plant (response pg 8).
This is not found persuasive. Fig. 2 is a poor resolution black and white photograph in which few, if any, details can be made out. No dark coloring can be seen in the vegetative parts of the plant. The photograph also does not, for example, provide any information about the hue of the dark kernels or asserted dark coloring can be seen in the vegetative parts. It also does not provide any information about other plant parts, like brace root coloration, anther color, dry husk colors, or endosperm type, all of which are traits commonly used in the art to describe corn varieties.
Applicant urges that the Declaration provides additional images of PennHFD (response pg 8).
This is not found persuasive. The Declaration is not part of the specification. A written description of a claimed invention must be in the specification, not outside of it.
Applicant urges that Table 2 describes the biochemical composition of PennHFD (response pg 8).
This is not found persuasive. First, Table 2 only describes a partial biochemical composition of PennHFD. Second, it does not describe the morphological and physiological characteristics of a corn variety.
The Declaration makes no statements regarding the phenotypic traits of PennHFD, other than providing black and white photos of the ear and plant (Declaration ¶6).
This is not found persuasive. The Declaration is not part of the specification. A written description of a claimed invention must be in the specification, not outside of it.
Claim Rejections - 35 USC §§ 102
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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1-2, 5 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by French (US 2018/0000035).
The rejection is repeated for the reasons of record as set forth in the Office action mailed 26 February 2026, as applied to claims 1-5 and 17-19. Applicant’s arguments and the Chopra/Calvo Declaration, both filed 27 July 2026, have been fully considered but they are not persuasive.
French teaches plants and seeds of corn line FAR614, which has a high concentration of anthocyanins, which are flavonoids (¶11, 42) and a hybrid produced from it (¶93-96, Table 4). These plants appear to be the instant PennHFD, as they have dark kernels (¶15) and appear to have all the physiological and morphological characteristics of PennHFD. French teaches corn seed produced on FAR614 (¶94) and using it for animal feed (¶39).
Response to Arguments
Applicant urges that French provides no information regarding FAR614’s parentage (response pg 11).
This is not found persuasive. Because there is no information on FAR614’s parentage, a comparison can only be made based on disclosed phenotype. Both FAR614 and PennHFD are both described as having high anthocyanins; thus, they appear to be identical.
French describes other morphological and phenotypic traits of FAR614 in Table 1. Applicant could have overcome this rejection with a Declaration comparing providing data showing that PennHFD differs in morphological and phenotypic traits from FAR614. Applicant is reminded that evidence submitted after final will not be considered unless Applicant provides a showing of good and sufficient reasons of why they were necessary and not earlier presented.
The Declaration states that that although FAR614 has high anthocyanins, there is no information regarding its parentage (Declaration ¶10).
This is not found persuasive. Because there is no information on FAR614’s parentage, a comparison can only be made based on disclosed phenotype. Both FAR614 and PennHFD are both described as having high anthocyanins; thus, they appear to be identical.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
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.
/Anne Kubelik/Primary Examiner, Art Unit 1663
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