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 1-20 are pending and are examined in the instant application.
Specification
2. The disclosure is objected to because of the following: in paragraph [00253], the Deposit Information is incomplete. Compliance with the deposit requirements may be held in abeyance until allowability is indicated.
Appropriate correction is required.
Claim Objections
3. Claims 1-20 are objected to because of the following:
In claims 1, 11 and 13, “seed” should be amended to “seeds” because more than seed is deposited.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
4. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
5. Claims 18 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process and a routine activity without significantly more. The claims recite a detecting step and optionally storing the results of said detecting on a computer readable medium. No particular method for detecting the polymorphism or the polymorphism to be detected is recited. This judicial exception is not integrated into a practical application because the detecting step is a mental determination process or data gathering step, and the additional generic computer readable medium does not add a meaningful limitation to the mental determination step because it amounts to simply implementing the mental determination step onto a computer readable medium. This is considered an insignificant extra-solution activity that is a well-understood, routine and conventional in the art. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the detecting step and storing the results of said detecting on a computer readable medium do not add significantly more to the inventive concept. In claim 19, “genetic marker analysis” is also a mental step. Thus, the claimed method is not an inventive concept. Moreover, it should be noted that the claimed method would preclude the public from the mere determination of whether or not Applicant’s invention is infringed.
Claim Rejections - 35 USC § 112(b)
6. 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.
7. Claims 1-20 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.
In claims 1, 11 and 13, the deposit information is missing. Cultivar 21270019 is not an art-recognized term. Absent a deposit, the metes and bounds of cultivar 21270019 cannot be determined. Compliance with the deposit requirements may be held in abeyance until allowability is indicated.
In claim 15(b), “growing a progeny plant of a subsequent generation“ should be amended to “growing a progeny plant of the subsequent generation” for proper antecedence.
Claim 18 is an incomplete method claim because it does not result in determining the genotype of the plant. No polymorphism and no genotype is recited. Additionally, the claim is directed to a method of determining the genotype of a progeny plant of the plant of claim 1. However, the recited method step does not address the progeny plant.
In claim 19, it is unclear where the results of the detecting are being transmitted.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(a)
8. 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.
9. Claims 1-20 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 specification and claims must be updated to include the deposit information. A declaration or the specification should be amended to provide statements (a)-(e) above. Proof of an accepted deposit is requested.
10. Claim 10 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 10 is directed to a plant produced by introducing a transgene conferring a desired trait into a plant of cultivar 21270019, wherein the plant comprises the transgene and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 21270019. Paragraph [0252] states that “a” and “an” are to be construed to cover both the single and the plural. Paragraph [0076] states that cultivar 24090316 may contain up to 15 transgenes. Thus, the claimed plant may contain up to 15 transgenes introduced by any method, including multiple outcrossings with undisclosed plants. Applicant has no working example of a plant comprising transgenes and its morphological and physiological characteristics. It is unpredictable what morphological and physiological characteristics of cultivar 21270019 are retained, lost or altered upon the introduction of transgene(s). The claimed plant lacks adequate written description because it is not known what methods were utilized to introduce the transgenes. Thus, the claimed plant further comprising a transgene lacks adequate written description. It is suggested Applicant amends the claim to indicate that the transgene is introduced by backcrossing or transformation.
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.
Nonstatutory Double Patenting
11. 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€ 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.
12. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application Nos. 18/406591 (hereafter ‘591), 18/406599 (hereafter ‘599), 18/406607 (hereafter ‘607), 18/406623 (hereafter ‘623), 18/406642 (hereafter ‘642) and 18/406647 (hereafter ‘647). Although the claims at issue are not identical, they are not patentably distinct from each other because cultivar 21270019 of the instant application has the same parents as cultivars 28020129 of ‘591, 28340729 of ‘599, 21250729 of ‘607, 23070729 of ‘623, 25120839 of ‘642 and 29130759 of ‘647. Moreover, most of the traits disclosed for cultivar 21270019 of the instant application and for the aforementioned cultivars are the same (+/- 10% s.d.). Differences in traits may be attributable to occasional variant traits that arise during backcrossing or direct introduction of a transgene [00195], natural variation in soybean caused by genetics and environment [0072], grader subjectivity, linkage drag during backcrossing, donor plant traits and/or statistical insignificance. Lastly, any morphological and physiological difference between these cultivars needs to be unexpected and practically significant. See Ex Parte C (27 USPQe2d 1492 (Bd. Pat. App. & Inter. 1992)), Ex Parte McGowen (Application No. 14996093, 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 21270019 of the instant application and that of the aforementioned cultivars. The plants, seeds, cells, methods of producing a soybean seed or plant, F1 hybrid, method of introducing a single locus conversion, plant and seed further comprising a single locus conversion or transgene for conferring herbicide tolerance, method of introducing a mutation into a plant genome, method of determining the genotype, and method of producing a commodity plant product are claimed in all applications.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/406654 (hereafter ‘654). Although the claims at issue are not identical, they are not patentably distinct from each other because all the commonly disclosed traits for cultivar 26120229 of ‘654 and cultivar 21270019 of the instant application are identical (+/- 10% std. dev.). Even though the parent designations of cultivar 26120229 of ‘654 are different from those of cultivar 21270019 of the instant application, no morphological and physiological characteristics of any of the parents are disclosed, there is no evidence that the parents of cultivar 26120229 of ‘654 and the parents of 21270019 of the instant application are genetically distinct, and the parent designations for the two cultivars are not art-recognized as being genetically distinct. Accordingly, cultivar 26120229 of ‘654 and cultivar 21270019 of the instant application appear to be the same. If there are undisclosed traits that differ between these two cultivars, these differences may be attributable to occasional variant traits that arise during backcrossing or direct introduction of a transgene [00195], natural variation in soybean caused by genetics and environment [0072], grader subjectivity, linkage drag during backcrossing, donor plant traits and/or statistical insignificance. Lastly, any morphological and physiological difference between these cultivars needs to be unexpected and practically significant. See Ex Parte C (27 USPQe2d 1492 (Bd. Pat. App. & Inter. 1992)), Ex Parte McGowen (Application No. 14996093, 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 21270019 of the instant application and that of cultivar 26120229 of ‘654. The plants, seeds, cells, methods of producing a soybean seed or plant, F1 hybrid, method of introducing a single locus conversion, plant and seed further comprising a single locus conversion or transgene for conferring herbicide tolerance, method of introducing a mutation into a plant genome, method of determining the genotype, and method of producing a commodity plant product are claimed in both applications.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,336,486 (hereafter ‘486). Although the claims at issue are not identical, they are not patentably distinct from each other because all the commonly disclosed traits for cultivar 16440906 of ‘486 and cultivar 21270019 of the instant application are identical (+/- 10% std. dev.). Even though the parent designations of cultivar 16440906 of ‘486 are different from those of cultivar 21270019 of the instant application, no morphological and physiological characteristics of any of the parents are disclosed, there is no evidence that the parents of cultivar 16440906 of ‘486 and the parents of 21270019 of the instant application are genetically distinct, and the parent designations for the two cultivars are not art-recognized as being genetically distinct. Accordingly, cultivar 16440906 of ‘486 and cultivar 21270019 of the instant application appear to be the same. If there are undisclosed traits that differ between these two cultivars, these differences may be attributable to occasional variant traits that arise during backcrossing or direct introduction of a transgene [00195], natural variation in soybean caused by genetics and environment [0072], grader subjectivity, linkage drag during backcrossing, donor plant traits and/or statistical insignificance. Lastly, any morphological and physiological difference between these cultivars needs to be unexpected and practically significant. See Ex Parte C (27 USPQe2d 1492 (Bd. Pat. App. & Inter. 1992)), Ex Parte McGowen (Application No. 14996093, 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 21270019 of the instant application and that of cultivar 16440906 of ‘486. The plants, seeds, cells, methods of producing a soybean seed, F1 hybrid, composition of seed in growth media, plant and seed further comprising a single locus conversion or transgene for conferring herbicide resistance such as glyphosate, method of producing a commodity plant product and commodity plant product comprising a cell are claimed in ‘486 and the instant application. ‘486 also discloses a method of determining the genotype of a plant by detecting a polymorphism in the nucleic acids of said plant by genetic marker analysis (col. 22, lns. 6-34).
Statutory Double Patenting
15. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process… may obtain a patent therefor…” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
16. Claims 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of copending Application No. 18/406654 (hereafter ‘654). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Even though the cultivar names and parent designations differ for these two applications, the morphological and physiological characteristics of the parents are not disclosed. All the commonly disclosed traits for cultivar 26120229 of ‘654 and cultivar 21270019 of the instant application are identical (+/- 10% std. dev.). Thus, there is insufficient evidence to indicate these cultivars are genetically distinct.
17. Claims 1-9, 11-17 and 20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-9 and 11-18 of Patent No. 12,336,486 (hereafter ‘486). Even though the cultivar names and parent designations differ for these two applications, the morphological and physiological characteristics of the parents are not disclosed. Thus, there is insufficient evidence to indicate these cultivars are genetically distinct. With regard to claims 5, 14 and 15, selfing a plant and crossing a plant with itself are the same.
Claim Rejections - 35 USC §§ 102 and 103
18. 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 (i.e., changing from AIA to pre-AIA ) 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.
19. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
20. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
21. Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Mason, J. (US Pat. No. 12,336,486 (A), filed Sep. 7, 2022). The prior art Mason teaches soybean cultivar 16440906 which shares all the commonly disclosed morphological and physiological characteristics with Applicant’s cultivar (+/- 10% std. dev.). The prior art discloses parents having different names from the parents of cultivar 21270019 of the instant application. However, because the phenotypic and genotypic of the parents of the prior art cultivar and those of the parents of cultivar 21270019 of the instant application are not disclosed, the different name designations are not given patentable weight here. The prior art discloses plants, seeds, cells, methods of producing a soybean seed, F1 hybrid, composition of seed in growth media, plant and seed further comprising a single locus conversion or transgene for conferring herbicide resistance such as glyphosate, method of producing a commodity plant product and commodity plant product comprising a cell (claims). The prior art also discloses a method of determining the genotype of a plant by detecting a polymorphism in the nucleic acids of said plant by genetic marker analysis (col. 22, lns. 6-34).
Accordingly, the claimed invention is anticipated by, or in the alternative, is obvious in view of the prior art. See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejected over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products. Since the Patent Office does not have the facilities to examine and compare the plant of Applicant’s with that of the prior art, the burden of proof is upon the Applicant to show an unobvious distinction between the claimed plant and the plant of the prior art. See In re Best, 562F.2d 1252, 195 USPQ 430 (CCPA 1977).
Conclusion
22. No claim is allowed.
23. 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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/PHUONG T BUI/Primary Examiner, Art Unit 1663