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 .
Duty of Disclosure
Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered material to patentability includes: 1) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 2) if backcrossing was used in the breeding history, then the recurrent parent should be disclosed along with any publications or public disclosures of the recurrent parent, and what events/loci/transgenes/traits were donated from the non-recurrent parent along with any publications or public disclosures of the events/loci/transgenes/traits or of the donor parent line itself, 3) if the parental varieties were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/transgenes/traits were donated from the non-recurrent parent, 4) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants (if backcrossing was used) should be disclosed. All of this information is material to patentability. If, for example, one of the parent plants is published but with a different name/designation, then the publication should be included in the IDS along with an explanation that the different name/designation is a synonym and how this plant is related to the instantly claimed plant.
Information Disclosure Statement
The references listed in the information disclosure statement (IDS) received on Feb. 21, 2025, have been considered. The Examiner lined through the second page because there were not references listed on the second page.
Specification
The disclosure is objected to because of the following informalities:
On page 49, in paragraph 245, there are two blank lines where there should be an Accession Number and a date of deposit.
Appropriate correction is requested.
Claim Objections
Claims 1, 5, 9, and 11-15, are objected to because of the following informalities:
Claims 1, 11, and 13 are objected to because they each include a blank line where there should be an Accession Number.
Claims 5, 14, and 15 each recite “crossing … … with itself”, and this is technically incorrect. A plant is cross-pollinated when it is crossed with a different plant, and when pollen from a plant fertilizes a flower from the same plant it is called “selfing” (Spec 4 ¶ 25).
Claims 9 and 12 each recite “insect or pest resistance” in a Markush group, and this is improper because the list of items in a Markush group should not include “or”. Applicant is advised to replace “insect or pest resistance” with - - insect resistance, pest resistance - - .
Appropriate correction is requested.
Claim Interpretation
Claim 13 recites “A soybean plant of soybean cultivar 00540608, further comprising a single locus conversion”. Applicant defines “soybean plant” as including “any single gene conversions of that cultivar” (Spec 33-34 ¶ ¶ 187-188). For this reason, claim 13 is directed to a plant of cultivar 00540608 which can include a single gene conversion, wherein the plant further comprises a single locus conversion.
Claim 16, in part (c), requires “… sufficient inbreeding to produce seed of an inbred soybean plant …”. This is understood to mean that there will be several repeats of self-pollinating or sibling-pollinating (part (b)) at the end of the method without inserting more crossing to a soybean of a different variety or different genetic background. This is routine in the art, and the ordinary artisan would understand that outcrossing to a soybean plant with different genetics would not result in an inbred soybean plant.
Claim Rejections - 35 USC § 112
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.
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.
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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Claims 1, 11, and 13 each include a blank line where there should be an accession number. All other claims depend from one of these three claims. “soybean cultivar 00540608” has no art accepted meaning. The claims recite this accession for a biological deposit recited as being representative of seed of the claimed cultivar, and it is understood to mean that plants/seeds of this cultivar will have the same genetic make-up as what is found in the deposited seeds and plants grown from these seeds will exhibit all of the physiological and morphological characteristics of the cultivar (not just the traits in Table 1). Without a biological deposit the metes and bounds of the claims are not clear.
Claim 13 is specifically indefinite because it is directed to a plant of cultivar 00540608 which can include a single gene conversion, wherein the plant further comprises a single locus conversion (see claim interpretation, above, which shows the definition of “soybean plant”). It is unclear how a plant can comprise a single gene conversion and also further comprise an additional single locus conversion. This would mean two conversions, therefore the word “single” would not have the art accepted meaning of “single”. It is unclear how there can be a “single” conversion and also be two conversions.
Lack of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 1-20 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to seeds and plants of Soybean variety 00540608 or plant parts derived from said variety. Since the plant is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. The specification does not disclose a repeatable process to obtain the plant. It is noted that Applicant has deposited seeds with the Provasoli-Guillard National Center for Marine Algae and Microbiota (NCMA) (Spec 52-53) but Applicant has not provided the Accession Number for the deposit nor the date the seeds were deposited. The remaining requirements for 37 C.F.R. 1.801-1.809 are satisfied by paragraph 253 on page 52.
Inadequate Written Description
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 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.
The claim is directed to a soybean plant produced by introducing a mutation into the genome of soybean cultivar 00540608 by applying ethyl methanesulfonate (EMS), gamma rays, or sodium azide. The claim encompasses a plant with an unlimited number of mutations relative to the unmutated genome of the cultivar (Spec 42-43 ¶ 220).
It is known in the art that treating seeds with chemical mutagens such as EMS can lead to multitudes of mutations within the genome. See, for example, Tsuda et al. (BMC Genomics (2015) Vol. 16; pp. 1-18) who teach that the average number of base changes per line of soybeans treated with EMS was 12,796 changes (Tsuda 1). Although claim 18 states that the mutagenized plant will comprise all of the morphological and physiological characteristics of soybean cultivar 00540608 other than the changes resulting from “a mutation in the genome”, it is clear that there is no limit to the number of mutations that could be introduced, and given how many can be introduced by mutagenesis, there could be numerous physiological and morphological changes as a result of mutagenesis. See, for example, Pavadai et al. (J. of Phytology (2009) Vol. 1; pp. 444-447) who teach that mutations in soybean resulted in phenotypes that were recorded as tall, dwarf, stunted, early and late flowering, early and late maturity, green color seed, wrinkled seed, single seeded pod, long pod, tetra foliate leaf, and male sterility (Pavadai 445), and also resulted in changes in protein and oil content (Id. 446). In addition, Khan et al. (J. of Cereals and Oilseeds (2013) Vol. 4; pp. 19-25) teach that soybean mutants had changes in seed germination, seedling survival, chlorophyll, leaves, height, growth type (including lodging), maturity, pod number, pod setting, yield (including seed size), protein/oil content, and disease resistance (Khan 20-3). These changes could alter most of the traits listed in Table 1 as the description for the instant cultivar (seed color, leaflet shape, maturity group, relative maturity, lodging, height, seed size, protein, and oil) (Spec 9).
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.” MPEP 2163 I A.
Furthermore, the instant specification does not have a single embodiment of a plant produced by mutating the instant cultivar actually reduced to practice. Given that the underlying genetics can be dramatically changed with thousands of base changes in the genomic DNA, and the physiological and morphological characteristics can be changed due to multiple changes in traits as a result of the mutations, the genus of mutant plants encompassed by claim 18 is not adequately described.
Double Patenting – Both Statutory and Non-Statutory
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.
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.
Statutory Double Patenting or, Alternatively, Nonstatutory Double Patenting over US Patent No. 11,771,043 B2
Claims 1-17, 19-20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-19 of US Patent No. 11,771,043 B2, or alternatively, on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US Patent No. 11,771,043 B2; claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US Patent No. 11,771,043 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the wording of the claims is identical except for the name of the cultivar. Furthermore, the breeding history for the two cultivars is identical (Spec 8-9; ‘043 col 6). Single plants were not pulled/separated until the F5 generation which would already be substantially inbred. The experimental name for the instant cultivar was 15MA31128-06-04 (Spec 9) whereas for the ‘043 cultivar it was 15MA31128-06-01 (‘043 col 6). The small differences in quantitative traits (relative maturity, height, seed size, protein, and oil) cannot be relied upon to distinguish the two cultivars because there was no standard deviation provided and these traits can be influenced by growth conditions. The two cultivars have the same herbicide resistance event and the same Soybean Cyst Nematode resistance allele (Spec 10; ‘043 col 7).
Because the Examiner cannot determine if there are, in fact, any statistically significant differences between the two cultivars, the Examiner is unable to determine if they are the same invention or if they are merely obvious variations on the same invention. See, for example, US Patent No. 10,694,695, which is subject to a terminal disclaimer over multiple patent applications that were directed to soybean cultivars produced by a breeding program using the same parental plants that resulted in “sibling” cultivars with very small differences in a few traits, such as: seed size, maturity, lodging, height, protein, oil, etc. This demonstrates that it is known in the art that a breeding program can produce different progeny lines with small differences in quantitative traits that are obvious variations over one another. It is noted that the ‘043 patent has a terminal disclaimer over a similar cultivar developed from the same breeding program.
Statutory Double Patenting or, Alternatively, Nonstatutory Double Patenting over US Patent No. 11,778,793 B2
Claims 1-17, 19-20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-19 of US Patent No. 11,778,973 B2, or alternatively, on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US Patent No. 11,778,973 B2; claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US Patent No. 11,778,973 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the wording of the claims is identical except for the name of the cultivar. Furthermore, the breeding history for the two cultivars is identical (Spec 8-9). Single plants were not pulled/separated until the F5 generation which would already be substantially inbred. The experimental name for the instant cultivar was 15MA31128-06-04 (Spec 9) whereas for the ‘793 cultivar it was 15MA31128-01-05 (‘793 col 6). The small differences in quantitative traits (relative maturity, lodging, height, seed size, protein, and oil) cannot be relied upon to distinguish the two cultivars because there was no standard deviation provided and these traits can be influenced by growth conditions. The two cultivars have the same herbicide resistance event and the same Soybean Cyst Nematode resistance allele (Spec 10; ‘793 col 7).
Because the Examiner cannot determine if there are, in fact, any statistically significant differences between the two cultivars, the Examiner is unable to determine if they are the same invention or if they are merely obvious variations on the same invention. See, for example, US Patent No. 10,694,695, which is subject to a terminal disclaimer over multiple patent applications that were directed to soybean cultivars produced by a breeding program using the same parental plants that resulted in “sibling” cultivars with very small differences in a few traits, such as: seed size, maturity, lodging, height, protein, oil, etc. This demonstrates that it is known in the art that a breeding program can produce different progeny lines with small differences in quantitative traits that are obvious variations over one another. It is noted that the ‘793 patent has a terminal disclaimer over a similar cultivar developed from the same breeding program.
Close Prior Art
In the prior art (US Patent No. 10,980,210 B2; issued on Apr. 20, 2021), Mason, J. T. teaches soybean cultivar 80202604 which shares every quantitative trait and very similar, although not identical, values for every qualitative trait with the instant soybean cultivar (Mason cols. 6-7; Spec 9-10). The soybean cultivars were developed by breeding programs that used completely different germplasm (Spec 8, Mason col 6), so presumably they have different underlying genetics. The small differences in qualitative traits on their own would not be sufficient to distinguish these two cultivars, however, taken together with their different breeding histories and with there being nothing on the record to show that they are closely related, genetically, this is sufficient to distinguish the instant cultivar.
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
Prosecution Insights