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
1. Claims 1-18 are pending and are examined in the instant application.
Claim Objections
2. Claims 1-18 are objected to because of the following:
In claim 1, the abbreviation “cv.” should be amended to “cultivar” the first time it is used.
In claims 1, 8, 14 and 16, “sample of seed” should be amended to “sample of seeds” because more than seed is deposited.
In claim 8, “a plant of” should be inserted before “red leaf lettuce”.
In claim 15(d), “yield” should be amended to “obtain”.
In claim 15(e), “generate” should be amended to “produce”.
Dependent claims are included.
Appropriate correction is required.
Double Patenting
3. 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€ 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.
4. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/676231 (hereafter ‘231). Although the claims at issue are not identical, they are not patentably distinct from each other because cultivar NNS-2109 of the instant application has the same parents as cultivar NNS-2132 of ‘231. Moreover, most of the traits disclosed for cultivar NNS-2109 of the instant application and cultivar NNS-2132 of ‘231 are the same or are similar (+/- 10% std. dev.). Differences between cultivar NNS-2109 of the instant application and cultivar NNS-2132 of ‘231 may be attributable to environmental variations, grader subjectivity, linkage drag during backcrossing, donor plant traits and/or statistical insignificance. Applicant admits that not all of the morphological and physiological characteristics of a variety are recovered when a desired heritable trait is introduced, and an occasional variant trait may arise during backcrossing or direct introduction of a transgene [0045]. Lastly, any morphological and physiological difference between these cultivars needs to be unexpected and practically significant. See Ex Parte C (27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992)), Ex Parte McGowen (Application No. 14/996093, P.T.A.B. Jun 15, 2020) and MPEP 716.02(b). Applicant does not disclose an unexpected and practically significant difference in a trait between cultivar NNS-2109 of the instant application and cultivar NNS-2132 of ‘231. The seed, plant, plant part, tissue culture, methods of producing a seed, F1 hybrid, method of producing a plant and method of producing food are claimed in both applications.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112(b)
5. 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.
6. Claims 1-18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 1, 8, 14(a) and 16, “said line” and “the line” lack antecedence. It is suggested these recitations be amended to “said cultivar” or “the cultivar”.
In claim 5, “a part thereof” does not have “all the physiological and morphological characteristics of the lettuce plant”.
In claim 6, it is unclear what is comprised in the claimed tissue culture.
In claim 8, “red leaf lettuce cv. Crimson Tide” has the same deposit accession number as cultivar NNS-2109. Does Applicant intend for this recitation to be “iceberg lettuce cv. NNS-2109”?
In claim 18, it is suggested “capable of use as” be deleted. No condition is set forth for the leaf tissue to be capable of use as food.
Dependent claims are included.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(a)
7. 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.
8. 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 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.
Since the seed 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. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. 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. If the deposit of the seed is 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 seed have been deposited under the Budapest Treaty and that the seed 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. 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 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;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
The deposit information in paragraph [0094} does not indicate that all restrictions upon the deposit is irrevocably removed. Evidence of an accepted deposit is requested.
9. 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 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, at the time the application was filed, had possession of the claimed invention.
Claim 17 is directed to a plant of lettuce cultivar NNS-2109 comprising a transgene for conferring a desired trait. The claim does not indicate how the transgene was introduced. Outcrossing with an undisclosed plant to introduce the transgene would alter the base genome and the morphological and physiological characteristics of lettuce cultivar NNS-2109. Applicant has no working example of a plant of lettuce cultivar NNS-2109 further comprising a transgene. It is unpredictable what morphological and physiological characteristics of cultivar NNS-2109 are retained, lost or altered upon the introduction of the transgene. The scope of the claim also encompasses the introduction of multiple transgenes for conferring multiple desired traits. The characteristics disclosed for lettuce cultivar NNS-2109 are not representative of the claimed plant comprising a transgene. Thus, the claimed plant comprising a transgene lacks adequate written description.
Accordingly, one skilled in the art would not have recognized Applicant was in possession of the claimed invention at the time of filing. See Written Description Guidelines, Revision 1, March 25, 2008, published online at http://www.uspto.gov/web/menu/written/pdf.
Conclusion
10. No claim is allowed. The claims are free of the prior art. The prior art teaches lettuce cultivar 50-0501050-B which has many of the same or similar (+/- 10% std. dev.) characteristics as Applicant’s cultivar NNS-2109, including seed color, light dormancy, shape of fourth leaf, cupping, spread of plant (spread of frame leaves), head shape, head class size, heads per carton, head weight, core diameter (diameter at base of head), days to bolting (days to seed stalk emergence from first water date) and bolting class (Knerr, L., US Pat. No. 7960617 (A), Table 1). However, at least their heat dormancy, head diameter, ratio of head diameter to core diameter, core height, bolting height (height of mature seed stalk) and spread of bolter plant differ.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 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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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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