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 .
Information Disclosure Statement
The applicant does not include an Information Disclosure Statement. The listed and cited reference(s) in the specification, is/are not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Status of claims
The applicant’s response filed 12/18/2024 has been entered.
Claims 18-20 have been canceled.
Claims 1, 6, 11, 13-15 have been amended.
In summary, claims 1-17 are pending and examined in this office action.
All previous objections and rejections not set forth below have been withdrawn in view of Applicant’s amendment and/or upon further consideration. See “Response to Arguments” at the end of office action.
The following rejections are repeated, modified and/or added for the reasons of record as set forth in the last Office action of 10/24/2024, and/or necessitated by the applicant’s amendments. Applicant’s arguments filed 12/19/2024 have been thoroughly considered but are not deemed fully persuasive.
Objection to the specification
The specification is objected because:
The claims have been amended to solely claim soybean variety CL1922757. The Deposit information has been amended to limit to soybean variety CL1922757. Thus, it is suggested to change the title from “SOYBEAN VARIEY” to ---SOYBEAN VARIEY CL1922757---.
In addition, in the amended specification of 12/18/2024, line 2, the “CL1922650” is not thoroughly deleted as the other varieties are.
Appropriate corrections are required.
Interpretation of claim 1
In claim 1, the “a plant” is interpreted as a plant grown from the seed of soybean variety CL1922757 wherein a representative sample of seed of said soybean variety CL1922757 has been deposited under NCMA Accession No. 202312094, in the same claim.
Claim Rejections - 35 USC § 112
Enablement/Deposit
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
5. Claims 1-17 are rejected under 35 U.S.C. 112(a), 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.
Claims are drawn to plant or seed of soybean variety CL1922757, and plant grown from the seed, as well as part, progeny, and method of using, the seed.
The examiner noticed that in the specification (as amended 12/18/2024), “Applicants have made a deposit of seeds of soybean cultivar CL1922757 with the Provasoli-Guillard National Center for Marine Algae and Microbiota (NCMA), 60 Bigelow Drive East Boothbay, ME 04544, USA NCMA number of the deposit is NCMA-202312094. The date of deposit for NCMA-202312094 was December 19, 2023 and was found viable on January 2, 2024. Access to this deposit will be available during the pendency of the application to the Commissioner for Patents and persons determined by the Commissioner to be entitled thereto upon request. Upon granting of a patent on any claims in the application, the Applicants will make the deposit available to the public pursuant to 37 CFR §1.808. Additionally, Applicants will meet the requirements of 37 CFR §1.801-1.809, including providing an indication of the viability of the sample when the deposit is made. The NCMA deposit will be maintained in that depository, which is 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 will be replaced if it becomes nonviable during that period”.
6. However, according to MPEP 2404.01, “The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990)”.
In this case, the statement of “all restrictions on the accessibility be irrevocably removed” is missing in the specification. Without such statement, the deposit does not meet the requirement.
7. A statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would address the issue raised herein.
Indefiniteness
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.
8. Claims 14-15 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 (claim 14, (e) line 2; claim 15, line 3) recite “essentially all of the physiological and morphological characteristics …..”.
The claims are deemed indefinite due to the word “essentially”. One of skill in the art would not know with reasonable certainty which characteristics of CL1922757 are required for a plant to be encompassed by the claims.
The Specification does not define the term “essentially all”.
The British Dictionary (via Websters.com) defines “essentially” as “in a fundamental or basic way; in essence” and Websters.com defines “essential” as “absolutely necessary; indispensable". It is unclear which characteristics of Armstrong are considered "essential", and it is unclear how many of the characteristics would need to be present to satisfy the limitation that “essentially all” of the characteristics are present.
See Nautilus, Inc. v. Biosig Instruments, Inc, No. 13-369, in which the Supreme Court held that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.
In addition, in the US Patent literatures, there are numerous examples of different interpretations of the word “essentially”, some are provided here:
US 20130291219 A1, paragraph 0011, which states “Essentially homogeneous corresponds to “at least about 97%” inbred seed.”, and this definition allows for about 3% variation.
US 20140072693 A1, paragraph 0007, which states "essentially homogeneous population of lettuce seed is exemplified to have at least about 97% of the total seed, including at least about 98%, 99%, or more of the seed", and this example allows for "about" 1%, 2%, or 3% variation.
US 20140228479 A1, paragraph 0039, which states ““essentially saturated” diene elastomers (low or very low content of units of diene origin, always less than 15%)”, and this allows for up to a 15% variation.
This limited sampling of US Patent publications demonstrates widely varying definitions for "essentially".
Thus, it is unclear how many changes of traits are allowed, and how much changes of physiological and morphological characteristics from CL1922757 are encompassed. One of skill in the art would not know with reasonable certainty how many characteristics can be changed in a plant and the plant still comprise "essentially all" of the characteristics as required by the claims.
For these reasons, the claims are indefinite because in light of the specification, the dictionary meaning, and the patent literatures, one of skill in the art would not know with reasonable certainty what the scope of the claimed invention is.
It is suggested to amend the claims to recite ---otherwise all--- rather than “essentially all” to overcome the rejection.
Remarks
By name search, instant CL1922757 does not have prior art in patent applications and NPLs.
The parent lines and breeding history of instant CL1922757 are provided by the applicant in the miscellaneous incoming letter filed 12/18/2024.
The parents of CL1922757 are CE1401679 and 14531823-09.
By the examiner’s search:
The parent CE1401679 was disclosed in US Patent 12178180 as a comparison (published 12/31, 2024, filed 9/7/2022; col 7, lines 47-57).
The parent 14531823-09 was disclosed and claimed in US Patent 10492442 as the other name of soybean 64490328/ATCC PTA-125384 (published 12/3/2019, filed 8/3/2018; Abstract; claims 1-2, col 6, lines 25-53).
The combination of CE1401679 and 14531823-09 (64490328) was not disclosed in patents, patent applications or NPLs. Thus, prior art does not teach any sibling(s) of instant soybean.
Response to Arguments
Objection to the specification
In view of the amendment of 12/18/2024, an objection is newly made.
Rejections Under 35 U.S.C. @ 112
Enablement/Deposit
The amendments of claims and the specification are not sufficient to overcome the rejection, as analyzed above.
35 U.S.C. § 112(b) – indefiniteness
In view of the amendments of claims and the specification, the previous rejection is withdrawn. A new rejection is made to claims 14-15, as analyzed above.
35 U.S.C. § 112(a) - Written Description
The rejection is withdrawn in view of the amendments of claims.
Rejections Under 35 U.S.C. 101
The applicant cancelled claims 18-20 to overcome the rejection.
Conclusion
No claim is allowed.
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.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo (Joe) Zhou can be reached on 571-272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Wayne Zhong/
Examiner, Art Unit 1662
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662