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 on merits in the present Office action.
Drawings
2. No drawings have been submitted in the instant application.
Information Disclosure Statement
3. Initialed and dated copy of Applicant’s IDS form 1449 filed in the paper of 04/01/2025 is attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
4. The disclosure is objected to because of the following informalities:
Page 47 of the specification: The deposit statement lacks NCMA Accession No. and the date deposit was made.
Appropriate corrections are required.
Claim Objections
5. Claim 6 is objected to because of the following informalities:
In claim 6, it is suggested to insert the recitation ---, representative seed of said soybean cultivar 94411038 having been deposited under NCMA Accession No. _______.---- at the end of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-20 are rejected under 35 U.S.C. 112(b), 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 1, 11 and 13 are rejected under 35 U.S.C. 112(b), as being indefinite in their recitation “NCMA Accession No.-____” because the “NCMA Accession No” is missing.
Claims 1, 6, 10, 11, 13, 16, 17 and 18 are rejected under 35 U.S.C. 112(b) as being indefinite in their recitation soybean cultivar “94411038” because the recitation does not clearly identify the claimed soybean cultivar and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “94411038” is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of the soybean plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the NCMA deposit number.
Dependent claims are also rejected because they fail to overcome the deficiencies of parent claims.
Claim Rejections - 35 USC § 112
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.
7. Claim 18 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(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has recently clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id.
Finally, the court held:
A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP Section 2163, page 174 of Chapter 2100 of the August 2005 version, column 1, bottom paragraph, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Claims are broadly drawn to a mutagenized soybean plant produced by the method of claim 17, wherein the mutagenized soybean plant comprises a mutation in the genome and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar “94411038”.
The breadth of claim encompasses a very large genus comprising unknown mutations (structures) having unknown or undescribed function.
Applicant’s broadly claimed genus encompasses a genus with unknown species whose structure and function relationship is unknown and not described.
The instant specification, however, only describes soybean variety “94411038” having physiological and morphological characteristics as described in Table 1.
Applicant fails to describe structure of representative species of Applicant’s broadly claimed genus and thus their function is either unknown or unpredictable.
There is no description of the structure required for the recited function, and no description of the necessary and sufficient elements of functional activity of diverse species involved in obtaining the desired functional phenotype. Applicant’s broadly claimed genus encompasses structures whose function is unknown.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, species soybean variety “94411038” is insufficient to describe the claimed genus.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing. The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
8. Claims 1-20 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. Since the seed claimed 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 (25 packets of 25 seeds each) 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.
Applicant has NOT indicated that Applicant intends to deposit the seeds at the ATCC in accordance with 37 CFR 1.801-1.809. Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the ATCC Accession No. and evidence of deposit to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application NOs: 19/400,152; 19/006,409; 18/975,863; 18/975,975; 18/975,903; 18/979,289 ; 18/782,861; 18/782,869; 18/822,972; 18/822,972; 18/443,271; 19/004,169 ; 18/776,056; 19/097,710; 19/003,985; 19/003,872; 19/097,723; 18/888,797; 18/888,797; 18/829,948 and 19/097,756.
Although the claims at issue are not identical but they are not patentably distinct from each other from cited copending applications because they share the same breeding history, morphological traits and most of the physiological traits. For example, the specification of copending applications share purple flower color, gray pubescence color, gray hilum color, tan pod color, maturity group II characteristics with the instant specification. Instantly claimed soybean variety also appears to be obvious variant of copending soybean varieties. The instant soybean variety and soybean variety of copending Applications also share similar values for relative maturity, seed oil and seed protein content, plant height, seed size and lodging. It may be noted that environmental factors and/or cultivation practices alone do influences such traits.
For example, amount of day light received and growth temperature affects or influences relative maturity in soybean cultivars. See Setiyono et al. (Field crop Research, 100:257-271; 2007, see in particular, abstract; Figures 1-13; Also see Iowa state University Extension and Outreach, Soybean Planting Decision Tool, Forecast and Assessment of Cropping systems (Facts), Published 2018; Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4).
Furthermore, soybean seed protein and seed oil content is influenced or affected by environmental conditions. See for example, Maestri et al. (J Sci Food Agric., 77:494-498, 1998; see in particular, abstract; Tables 1-6), also see OJo et al. (Global Journal of Agricultural Sciences, volume 1, NO. 1, pages 27-32, January 2002; see in particular, abstract, Tables 1-4; appendix 1).
Likewise, soybean plant height is influenced or affected by environmental conditions. See for example, Yang et al. (BMC Plant Biology, 21:63, 2021; see in particular, paragraph bridging left and right columns), also see Popovic et al. (Soil and food; 2nd International and 14th National Congress of Soil Science Society of Serbia, 25-28th September, Novi Sad, Serbia, 2017, pages 1-294; see in particular chapter on “Effect of nitrogen fertilization on soybean plant height in arid year”, tables 1-3; figures 1-3 at pages 65-71); Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4).
Likewise, soybean seed size is also affected or influenced by environmental conditions. See for example, Delouche (Hortscience, 15(6): pages 13-18, 1980; see in particular Figure 1 at page 15); Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4) .
Likewise, environment and production practices impacts lodging score in soybean. See for example, Cooper (Agronomy Journal, 63:490-493, 1971; see in particular abstract; Tables 1-7).
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
10. Claims 1-20 are ejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent Nos. 11234405;11252923; 11206797; 11234406 and 11259495.
Although the claims at issue are not identical but they are not patentably distinct from each other from cited issued US Patent Nos. because they share the same breeding history, morphological traits and most of the physiological traits. For example, the specification of issued patent Nos. share purple flower color, gray pubescence color, gray hilum color, tan pod color, maturity group II characteristics with the instant specification. Instantly claimed soybean variety also appears to be obvious variant of issued US Patents on soybean varieties. The instant soybean variety and soybean cultivars of cited issued patents also share similar values for relative maturity, seed oil and seed protein content, plant height, seed size and lodging. It may be noted that environmental factors and/or cultivation practices alone do influences such traits.
For example, amount of day light received and growth temperature affects or influences relative maturity in soybean cultivars. See Setiyono et al. (Field crop Research, 100:257-271; 2007, see in particular, abstract; Figures 1-13; Also see Iowa state University Extension and Outreach, Soybean Planting Decision Tool, Forecast and Assessment of Cropping systems (Facts), Published 2018; Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4).
Furthermore, soybean seed protein and seed oil content is influenced or affected by environmental conditions. See for example, Maestri et al. (J Sci Food Agric., 77:494-498, 1998; see in particular, abstract; Tables 1-6), also see OJo et al. (Global Journal of Agricultural Sciences, volume 1, NO. 1, pages 27-32, January 2002; see in particular, abstract, Tables 1-4; appendix 1).
Likewise, soybean plant height is influenced or affected by environmental conditions. See for example, Yang et al. (BMC Plant Biology, 21:63, 2021; see in particular, paragraph bridging left and right columns), also see Popovic et al. (Soil and food; 2nd International and 14th National Congress of Soil Science Society of Serbia, 25-28th September, Novi Sad, Serbia, 2017, pages 1-294; see in particular chapter on “Effect of nitrogen fertilization on soybean plant height in arid year”, tables 1-3; figures 1-3 at pages 65-71); Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4).
Likewise, soybean seed size is also affected or influenced by environmental conditions. See for example, Delouche (Hortscience, 15(6): pages 13-18, 1980; see in particular Figure 1 at page 15); Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4) .
Likewise, environment and production practices impacts lodging score in soybean. See for example, Cooper (Agronomy Journal, 63:490-493, 1971; see in particular abstract; Tables 1-7).
Claim Rejections - 35 USC § 103
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
11. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eby (US Patent No. 9,591,827; Issued March 14, 2017 in view of Beuckeleer (US Patent NO. 8,017,756; Issued September 13, 2011).
The claims are broadly drawn to seeds and plants of soybean cultivar 94411038, composition comprising said cultivar, methods of their use to produce a commodity product such as oil or protein isolate, methods of their breeding to produce F1 hybrids or single locus conversions or inbreds therefrom. The instant specification teaches that soybean cultivar 94411038 has yellow and dull seeds, yellow cotyledons, ovate leaflets, indeterminate growth, purple flowers, gray hilum, gray pubescence, tan pod, maturity group II, and a relative maturity of 2.9. The instant specification also teaches that soybean cultivar 94411038 contains GM_A19788 event (also known as event MON89788) conferring resistance to glyphosate herbicides including ROUNDUP; GM_A92205 event (also known as event MON87708) conferring resistance to dicamba herbicides; and event A5547-127 (with alternate designations “EE-GM2,” “LL55,” and “ACS-GM006-4), which confers tolerance to glufosinate herbicides. The specification also teaches that soybean cultivar 94411038 is similar to soybean variety 11KA71163-56-06 which does not have event A5547-127 conferring resistance to glufosinate herbicides. See, for example, table 1 at pages 8-10 of the instant specification.
Eby teaches soybean cultivar 57160653 having yellow and dull seeds, yellow cotyledons, ovate leaflets, indeterminate growth, purple flowers, gray hilum, gray pubescence, tan pod, maturity group II, and a relative maturity of 2.4. These traits are shared with instant soybean variety 94411038 of instant invention. Eby also teaches transforming said soybean cultivar 57160653 with a transgene by transformation and by backcrossing from another transgenic soybean plant. The reference also teaches an F1 hybrid produced from such crosses and a method of making said F1 hybrid. The reference also teaches a method of making soybean commodity product (e.g. protein, flour, oil etc.). Eby also teaches that soybean cultivar 57160653 contains GM_A19788 event (also known as event MON89788) conferring resistance to glyphosate herbicides including ROUNDUP; and GM_A92205 event (also known as event MON87708) conferring resistance to dicamba herbicides. Eby further teaches that soybean variety 11KA71163-56-06 is same as soybean cultivar 57160653. Eby also teaches introducing herbicides gene(s) through backcrossing using soybean cultivar 57160653 as recurrent parent.See in particular, claims 1-19; columns 1-36; table 1.
Eby does not teach that instant soybean cultivar 94411038 comprises the event A5547-127 conferring resistance to glufosinate herbicides.
Beuckeleer teaches a soybean plant comprising a transgenic event A5547-127 conferring resistance to glufosinate herbicides. See in particular, columns 1-20; claims 1-14.
The instant claims are prima face obvious over the teachings of Eby because soybean cultivar 57160653 taught by Eby and soybean variety 94411038 of the instant application appear to be obvious variations.
It would have been obvious to an ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Eby to introduce event A5547-127 of Beuckeleer into a soybean plant using soybean variety 11KA71163-56-06 as the recurrent parent. Obviously one of ordinary skill in the art would have been motivated to do so for the purpose of creating soybean variety 11KA71163-56-06 with glufosinate herbicide resistant soybean variety using standard breeding methods as taught by Eby to introduce a single locus conversion comprising a transgene, and thus arrive at the Applicant’s claimed variety with a reasonable expectation of success and without any surprising results.
The instant soybean variety and soybean cultivar of Eby also share similar values for relative maturity, seed oil and seed protein content, plant height, seed size and lodging. It may be noted that environmental factors and/or cultivation practices alone do influences such traits.
For example, amount of day light received and growth temperature affects or influences relative maturity in soybean cultivars. See Setiyono et al. (Field crop Research, 100:257-271; 2007, see in particular, abstract; Figures 1-13; Also see Iowa state University Extension and Outreach, Soybean Planting Decision Tool, Forecast and Assessment of Cropping systems (Facts), Published 2018; Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4).
Furthermore, soybean seed protein and seed oil content is influenced or affected by environmental conditions. See for example, Maestri et al. (J Sci Food Agric., 77:494-498, 1998; see in particular, abstract; Tables 1-6), also see OJo et al. (Global Journal of Agricultural Sciences, volume 1, NO. 1, pages 27-32, January 2002; see in particular, abstract, Tables 1-4; appendix 1).
Likewise, soybean plant height is influenced or affected by environmental conditions. See for example, Yang et al. (BMC Plant Biology, 21:63, 2021; see in particular, paragraph bridging left and right columns), also see Popovic et al. (Soil and food; 2nd International and 14th National Congress of Soil Science Society of Serbia, 25-28th September, Novi Sad, Serbia, 2017, pages 1-294; see in particular chapter on “Effect of nitrogen fertilization on soybean plant height in arid year”, tables 1-3; figures 1-3 at pages 65-71); Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4).
Likewise, soybean seed size is also affected or influenced by environmental conditions. See for example, Delouche (Hortscience, 15(6): pages 13-18, 1980; see in particular Figure 1 at page 15); Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4) .
Likewise, environment and production practices impacts lodging score in soybean. See for example, Cooper (Agronomy Journal, 63:490-493, 1971; see in particular abstract; Tables 1-7).
Conclusion
12. Claims 1-20 are rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. 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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/VINOD KUMAR/ Primary Examiner, Art Unit 1663
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