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 .
Status of the Claims
The claims filed 28May2024 are acknowledged and have been fully considered. Claims 1-18 are pending, original, and examined on the merits herein.
Priority
There is no priority claim of record. Claims 1-18 have an effective filing date that is the same as the actual filing date of this nonprovisional application: 28May2024.
Information Disclosure Statement
No Information Disclosure Statement (IDS) is currently of record.
Deposit Rejection
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-18 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 claims contain 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.
Since seed deposited under NCMA Accession No. 202312103 is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public (35 U.S.C. 112). If a seed, or seed of the claimed plant is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112 (37 C.F.R. § 1.802). The specification does not disclose a reproducible 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. Therefore, a deposit thereof is believed to be necessary.
If the deposit of the seed is made, or will be made, under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating “the deposit has been made, or will be made, under the Budapest Treaty and ‘all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent’” (see 37 C.F.R. § 1.808(a)(2)) would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria 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 that:
access to the deposit will be available during pendency of the patent application upon request to, and approval from, the Director (37 C.F.R. § 1.808(a)(1));
all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent (37 C.F.R. § 1.808(a)(2));
the deposit will be maintained in a public depository for a term of at least thirty (30) years or at least five (5) years after the most recent request for the furnishing of a sample of the deposit was received by the depository, whichever is longer (37 C.F.R. § 1.806);
the viability of the biological material will be tested at the time of the deposit and a corresponding viability statement has been or will be filed if the deposit is not being made under the Budapest Treaty (37 C.F.R. § 1.807); and
the deposit will be replaced if it should ever become unviable (37 C.F.R. § 1.805).
The information at ¶94 on page 23 of the specification is acknowledged, however, Applicant has not provided several pieces of information such as whether the deposit is made under the Budapest Treaty, viability details of the deposit, the number of seeds which were deposited, and whether the seed is inbred. In addition, the five statements (a-e) above are specific and not recited as needed at ¶94 on page 23 of the specification. Given the particularity of the deposit language rules, it is recommended that Applicant simply copy/paste these required statement(s) into their signed reply and, fur future applications, it is highly recommended that the specification recite a “catch all” phrase such as “In any event, all of the requirements set forth in 37 C.F.R. §§ 1.801-1.809 have, or will be, complied with.”
Claim Objections
Claim 1 is objected to because of the following informalities: at the first recitation of the abbreviation “cv.” in the claims (currently claim 1), please write it in long form as in “… lettuce cultivar (cv.) NNS-2132, a ….” Appropriate correction is required.
Claims 5 and 8 are objected to because of the following informalities: a phrase is missing from these claims. Please amend claim 2 as follows: “… morphological characteristics of the lettuce plant of claim 2, when grown in the same environmental conditions.” and please amend claim 8 as follows: “… morphological characteristics of iceberg lettuce cv. NNS-2132 when grown in the same environmental conditions, a sample of seed ….” Appropriate correction is required.
Claim 8 is further objected to because of the following informalities: please amend the claim as follows “… characteristics of a plant of iceberg lettuce cv. NNS-2132 ….” Appropriate correction is required.
Claims 8, 14, 16 are objected to because of the following informalities: to be consistent with the language of claim 1, please amend “line” in these claims to “cultivar”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: please change “yield” in part (d) to “obtain” and please change “generate” at part (e) to “produce” (to coordinate with the preamble of claim 14). Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Written Description
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
– I –
Claim 5 is 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.
This claim is directed toward plants or plant parts that have “all of the” characteristics/traits of a plant of iceberg lettuce cultivar NNS-2132 (see Tables 1 and 2 of the specification), but that do not have any structural/genomic relationship with a plant (or plant part) of iceberg lettuce cultivar NNS-2132. Said another way, these claims encompass lettuce plants with any genomic structure and that, nonetheless, have all of the characteristics/traits of a plant of iceberg lettuce cultivar NNS-2132.
Applicant has only described one structure (genomic structure) that is capable of causing all of the characteristics/traits of a plant of iceberg lettuce cultivar NNS-2132 (i.e., that can cause the characteristics/traits listed in Tables 1 and 2): the structure (genomic structure) represented by the sample of seed deposited under NCIMB Accession No. 202312103. But these claims are not tethered to the genomic structure of the deposited seed. As currently written, the claimed plant/part does not need to share any genomic material with that of the deposited seed. To ensure a clear record, please note that claim 5 does not depend upon claim 2 and merely compares the characteristics of the claimed plant to those of claim 2.
The prior art does not ameliorate the deficiencies of the specification at least because there appears to be no prior art which teaches a plant/part having the characteristics/traits listed in Tables 1-2 of this specification (i.e., the characteristics/traits of a plant/part of iceberg lettuce variety NNS-2132).
Without more from Applicant, a skilled artisan at the time the present invention was made would not reasonably believe Applicant was in possession of obtaining a plant/part exhibiting all of the characteristics/traits listed in Tables 1-2 with a plant that does not share any genomic material with that of a plant/part of iceberg lettuce cultivar NNS-2132—a skilled artisan would only believe Applicant was in possession of obtaining one such plant/part via the plant/part being of the iceberg lettuce cultivar NNS-2132 (F0) or an F1 hybrid plant/part obtained therefrom.
– II –
Claim 17 is 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.
Claim 17 is directed toward a lettuce plant produced via introducing any number of transgenes (no upper limit) into a plant/part of iceberg lettuce cultivar NNS-2132 (see method claim 16). To be clear, the “desired trait” is not defined at claim 16 and the number of transgenes to confer such “desired trait” is also not defined. Therefore, looking at claim 17, the plants/parts being claimed may have any number of “desired traits” (no upper limit) that are not exhibited by a plant/part of iceberg lettuce cultivar NNS-2132. It follows that the claimed plants/parts may have any number of transgenes (no upper limit) that are not present within a plant/part of iceberg lettuce cultivar NNS-2132. It is noted that a transgene may be introduced via locus conversion (e.g., outcrosses). Finally, the claimed plants/parts are not currently limited to a particular outcross generation and they do not need to have any particular characteristic(s)/trait(s).
The specification only describes plants/parts of iceberg lettuce cultivar NNS-2132 (F0 or F1 hybrid plants/parts therefrom) and their characteristics/traits at Tables 1-2 of the specification.
A skilled artisan could not reasonably expect, with reasonable certainty, what the physiological and morphological characteristics of the claimed plants may be (= the claimed subject matter may be so far removed from a plant/part of iceberg lettuce cultivar NNS-2132 via transgene insertions, that the characteristics of the claimed plants/parts cannot be reasonably predicted). Said another way, the claimed subject matter is not tethered to novel starting materials (MPEP § 2116) by either (1) being limited to the F0 or F1 generation (in the case of locus conversions) or (2) explicitly requiring that the claimed plants/parts “express the desired trait and otherwise express all of the physiological and morphological characteristics of a plant of iceberg lettuce cultivar NNS-2132 when grown under the same environmental conditions”.
Without more information from Applicant, a skilled artisan at the time this application was filed would not reasonably recognize Applicant as being in possession of the full metes and bounds of these claims.
It would be remedial of this rejection to (I) explain (on the record, e.g., in remarks) how the specification (in view of the prior art) evidences possession of the full metes and bounds of the claimed plants; or (II) to amend the claims so that they are tethered to novel starting materials (MPEP § 2116). Applicant may wish to consider amending the claim so that (1) the transgene is introduced by locus conversion and the claimed plant is in the F1 generation or (2) the plant/part “expresses the desired trait and otherwise expresses all of the physiological and morphological characteristics of a plant of iceberg lettuce cultivar NNS-2132 when grown under the same environmental conditions”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18676071 (MLB Ref. No. 131236-5014-US) regarding iceberg lettuce cultivar NNS-2109. Although the claims at issue are not identical, they are not patentably distinct from each other because the parentage of each cultivar (NNS-2132 and NNS-2109) appears to be the same and the characteristics/traits of these cultivars appear to be materially the same (compare Tables 1-2 of each specification).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The following is a statement of reasons for the indication of allowable subject matter: this application appears to be the first to teach or suggest a lettuce plant or part having the characteristics/traits of a plant of iceberg lettuce cultivar NNS-2132 (i.e., those listed in Tables 1-2), or a lettuce plant obtained via the parentage described at FIG. 1 and ¶¶33-35 on pages 9-10 of the specification (a representative genomic structure for which is provided via the deposited seed). The closest prior art may be identified as US20160044885 (WAYCOTT, Appl. No. 14461234) regarding lettuce line SV0822LD. The plants/parts of the presently claimed iceberg lettuce cultivar NNS-2132 is materially different than a plant/part of lettuce line SV0822LD in at least: fourth leaf apical margin, fourth leaf basal margin, fourth leaf undulation, fourth leaf reflexing, mature leaf color, mature leaf flossiness, mature leaf blister size, mature leaf shape, mature plant head weight, and mature plant core height.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
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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.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663