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.
Specification
The disclosure is objected to because of the following informalities:
On page 53, in paragraph 252, 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 5 ¶ 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 21220725, further comprising a single locus conversion”. Applicant defines “soybean plant” as including “any single gene conversions of that cultivar” (Spec 37 ¶ 194). For this reason, claim 13 is directed to a plant of cultivar 21220725 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.
Claim 13 is 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.
Claim 13 is directed to a plant of cultivar 21220725 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 21220725 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 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 252 on page 53.
Claim Rejections - 35 USC §§ 102/103
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.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Prior Art US Patent No. 11,083,166 B1
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Grams, P. J. A. (US Patent No. 11,083,166 B1; issued on Aug. 10, 2021).
The instant claims are directed to seeds, plants, and plant parts of soybean cultivar (variety) 21220725, and products derived from said plants, and methods of using said plants.
Grams teaches soybean cultivar (variety) 97820565 which shares identical qualitative traits when compared to the instant soybean variety, including having the same resistance allele: Rhg 1, and shares very similar quantitative traits compared to the instant soybean variety (Spec 10; Grams cols. 6-7). The prior art soybean variety is also known as 15CA30915-65-02 (Grams col. 6) and this is very similar to the experimental designation of the instant variety, 15CA30915-27-02 (Spec 9), differing only in the digits after the first dash. Looking at the breeding history for the prior art soybean compared with the instant soybean, it is identical straight through the F6 generation where plant rows were grown near Chacabuco, Argentina in 2017 – 2018, and this is the point at which the alphanumeric designations were assigned. These two cultivars could have been the identical plant all the way through F5 when single seeds were pulled, or perhaps even through the yield trials in Argentina with a further generation. For this reason, the genetics may very well have already been fixed, stable, and uniform prior to the siblings being separated from one another.
With regard to the specific limitations required by claims 1-20, the ‘166 patent has identical claim language for claims 1-17 and 20 with the exception of the alphanumeric variety name. With regard to instant claims 18 and 19, the Examiner takes official notice that detecting a polymorphism in a sample of nucleic acids was routine in the art at the time of filing, as was sequencing, marker analysis, and storing results on a computer. This is evidenced by columns 30-31 in the ‘166 patent and the references cited therein.
There is nothing in the current record to distinguish the prior art cultivar from the instant cultivar. In the event Applicant can provide a difference that distinguishes between these two cultivars, then the Examiner will be required to do the Deere Analysis to determine if the difference is a non-obvious difference. That analysis cannot be completed in this Office Action, because the Examiner is not aware of any distinguishing features.
Double Patenting
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.
Double Patenting over US Patent No. 11,083,166 B1
Claims 1-17 and 20 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of prior U.S. Patent No. 11,083,166 B1; or alternatively claims 1-7 and 20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,083,166 B1. Claims 18 and 19 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,083,166 B1.
The analysis to compare between the instant claims and the ‘166 claims is presented, above, in the rejection under 35 USC 102/103. The same rationale applies for this rejection. For this reason the instant claims are either identical to the prior art claims and are not patentable under 35 USC 101, or, in the event there is a difference that distinguishes the ‘166 variety from the instant variety, then the Examiner will need to do the Deere Analysis to determine if the difference is non-obvious and unpatentable on the ground of non-statutory double patenting.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo "Joe" Zhou can be reached at (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CATHY KINGDON
Primary Examiner
Art Unit 1662
/CATHY KINGDON/ Primary Examiner, Art Unit 1662