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 .
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Claims 1-22, pending in this application, are examined.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 3, paragraph [0013]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 7 and 11 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.
The claims require broccoli plant with deposited seed. Since the seed 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. 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 repeatable 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. It is noted that Applicant has deposited the broccoli lines identified as SSC-BRO-22-001, SSC-BRO-22-002, and SSC-BRO-22-003 under accession numbers FERM BP-22456, FERM BP-22457, and FERM BP-22458. However, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made under the terms of the Budapest Treaty, then a statement, an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds has been deposited and accepted, and 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 requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, an affidavit or declaration, or by someone empowered to make the same, 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 in accordance with 37 CFR 1.808(a)(2):;
(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 effective 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 inviable.
For each deposit made pursuant to these regulations, the specification shall be amended to contain (see 37 CFR 1.809):
The accession number for the deposit;
The date of the deposit;
A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
The name and address of the depository.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 4-6 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hewitt et al (US 9, 480, 210 B2).
The claims are drawn to are drawn a broccoli plant or a progeny thereof, comprising in its nuclear genome a gene involved in producing florets, which enables production of florets of uniform size with high yield, wherein the gene involved in producing florets is capable of expressing a genetic trait in which a ratio (%) of the number of floret portions of 2.0 cm to 4.0 cm in diameter to a total number of floret portions (the ratio of floret portions) is at least 40%, when the diameter of a whole head is 14.0 cm to 17.0 cm, wherein expression of anthocyanin is suppressed, wherein the gene is originated from broccoli, Chinese kale, or cauliflower, wherein the gene involved in producing florets is capable of expressing a genetic trait in which the ratio of floret portions is 41%, 55%, 60%, 65%, 70% or more. The claims are also drawn to a hybrid plant or a progeny thereof, obtained by using the broccoli plant as a parental line, a part of a plant body a head, a floret or seed of the broccoli plant ; and a method for producing an F1 seed of the broccoli plant by crossing the broccoli plant with another broccoli plant or to another plant which is capable of crossing to the broccoli plant and harvesting an F1 seed; and a method for producing a processed product of florets of broccoli plant cutting out florets of secondary stems from a whole head of the broccoli plant; and optionally packaging the cut out florets of secondary stems; and a method for producing a processed product of florets of broccoli, comprising the steps of: cutting out florets of secondary stems from a head of a broccoli plant in which a ratio (%) of a number of floret portions of 2.0 cm to 4.0 cm in diameter to a total number of floret portions (the ratio of floret portions) is at least 40% when a diameter of the head is 14.0 cm to 17.0 cm; and optionally packaging the cut our florets of the secondary stems.
Hewitt et al teach cultivated broccoli plants having a head comprising a primary stem with branched secondary stem with multiple individualized florets at the top, wherein the heads are harvested at maturity when they have florets with adequate size and a uniform green color with little or no yellowing; said broccoli plants comprise the genetic information responsible for said multiple individualized floret trait. At the paragraph bridging columns 8 and 9, Hewitt et al state “…thanks to the arrangement of those florets substantially in the same plane, these florets are more uniform as regards to their size and green color, including the secondary stem. This allows obtaining a higher yield regarding the production of individualized florets”. Hewitt et al also state that the yield of floret can be increased by increasing the size of the head. Hewitt et al teach that size of the floret is measured in equatorial diameter and vary from 30mm to 60 mm for about 30% to 70% of the florets; florets with diameter from 30 mm to 45mm represent from about 20% to 40%of the total number of the florets; florets with diameter lower than 30 mm represent from 30% to 45% of the total number of the florets (column 9, lines 31-64)). Hewitt et al teaching identified broccoli line BR51512 with broccoli head of about 23 cm having 350 g of average weight of the head, average number of florets per head was 30. Hewitt et al further teach breeding plants of said broccoli line BR51512 to produce F1 hybrid seed/plant broccoli plants with protruding head and having florets comprised within a plane substantially parallel to the ground; such traits were inherited in a simple Mendelian manner and transmitted to progeny. The use of said florets and heads for the manufacture of broccoli processed and/or packaged food products is also taught by Hewitt et al (see at least claims 1-11). Therefore, Hewitt et al teach all claim limitations.
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 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.
Claims 1-6, 8-10, and 12-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hewitt et al (US 9, 480, 210 B2) in view of Van den Bosch et al (US 9, 220, 208 B2) and Takahashi et al (The horticulture Journal (2021)90(1):75-84; Applicant’s IDS)
Hewitt et al teach cultivated broccoli plants having a head comprising a primary stem with branched secondary stem with multiple individualized florets at the top, wherein the heads are harvested at maturity when they have florets with adequate size and a uniform green color with little or no yellowing, and methods of producing F1 progeny by breeding said plant with another broccoli plant, as discussed above.
Hewitt et al do not explicitly teach the limitations of “wherein the expression of the anthocyanin is suppressed (claim 3), and florets with 14 to 17 cm, the ratio (%) of the number of the floret parts having diameter of from 2.0 cm to 4.0 cm to the total number of the small florets parts that is at least 40%, 41% or more (claims 8-10, 12-14 and 21-22).
Van den Bosch et al teach broccoli plant having curd or head comprising at least 6, 7, 8, 9 or 10 detached florets or broccoli is increasing being grown and florets are removed from the head for frozen; wherein the floret size is preferably in the range of 20-40 mm. Since Hewitt et al teach broccoli heads are harvested at maturity when they have florets with adequate size and a uniform green color with little or no yellowing; it is apparent that the anthocyanin expression is suppressed.
Takahashi et al teach that extending the growing period of the broccoli plant and sparse planting have resulted in enlarged broccoli heads with increased floret yield. Takahashi et al also teach that the head diameter of the broccoli in the extended cultivation plot was 15 cm to 21 cm; so the large head production enabled more efficient production and increased floret yield compared to conventional cultivation methods.
Therefore, it would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to produce the broccoli plants with florets of uniform size and green color with high yield and less or no yellowing as taught by Hewitt et al, and to modify that method by incorporating broccoli plants with detachable small florets as taught by Van den Bosch et al, and/or by incorporating the cultivation period of the broccoli plant to increase the head size together with the size and yield of the florets as taught by Takahashi et al, given that florets of uniform size (small) and green color with high yield have commercial value as taught by each of Hewitt et al, and Takahashi et al. One would have been motivated to produce broccoli plants having florets of uniform size and green color with high yield, less or no yellowing to facilitate processing of the florets after harvest as suggested by each of Hewitt and Takahashi et al.
Applicant’s unexpected result is limited to plants of broccoli lines identified as SSC-BRO-22-001, SSC-BRO-22-002, and SSC-BRO-22-003 and deposited under accession numbers FERM BP-22456, FERM BP-22457, and FERM BP-22458 (provided the deposit is perfected), and method of producing F1 broccoli plants via breeding methods using said broccoli plants.
From the teachings of the cited prior art references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claims 1-6, 8-10, and 12-22 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 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 claims are broadly drawn to a genus of broccoli plants and progeny comprising in its nuclear genome a genus of unidentified genes involved in producing florets, which enables production of florets of uniform size with high yield, wherein the gene involved in producing florets is capable of expressing a genetic trait in which a ratio (%) of the number of floret portions of 2.0 cm to 4.0 cm in diameter to a total number of floret portions (the ratio of floret portions) is at least 40%, when the diameter of a whole head is 14.0 cm to 17.0 cm, wherein expression of anthocyanin is suppressed, wherein the gene is originated from broccoli, Chinese kale, or cauliflower, wherein the gene involved in producing florets is capable of expressing a genetic trait in which the ratio of floret portions is 41%, 55%, 60%, 65%, 70% or more. The claims are also drawn to a hybrid plant or a progeny thereof, obtained by using the broccoli plant as a parental line, a part of a plant body a head, a floret or seed of the broccoli plant ; and a method for producing an F1 seed of the broccoli plant by crossing the broccoli plant with another broccoli plant or to another plant which is capable of crossing to the broccoli plant and harvesting an F1 seed; and a method for producing a processed product of florets of broccoli plant cutting out florets of secondary stems from a whole head of the broccoli plant; and optionally packaging the cut out florets of secondary stems; and a method for producing a processed product of florets of broccoli, comprising: the steps of: cutting out florets of secondary stems from a head of a broccoli plant in which a ratio (%) of a number of floret portions of 2.0 cm to 4.0 cm in diameter to a total number of floret portions (the ratio of floret portions) is at least 40% when a diameter of the head is 14.0 cm to 17.0 cm; and optionally packaging the cut our florets of the secondary stems.
The specification describes identification of broccoli lines SSC-BRO-22-001, SSC-BRO-22-002, and SSC-BRO-22-003, deposited under accession numbers FERM BP-22456, FERM BP-22457, and FERM BP-22458 (provided the deposit is perfected), and method of producing F1 broccoli plants via breeding using said broccoli plants (Examples 1-6). These are genus claims.
The purpose of the written description is to ensure that the inventor had possession at the time the invention was made, of the specific subject claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
“The test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations. Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966”. While the written description requirement does not demand either examples or an actual reduction, actual “possession” or reduction to practice outside of the specification is not enough. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). Rather, it is the specification itself that must demonstrate possession. Id.
The specification has not described a representative species of the genus of plants claimed. Neither the specification nor the prior art provides structure-function correlation of the broccoli plants having florets of uniform size and high yield, in which a ratio (%) of the number of floret portions of 2.0 cm to 4.0 cm in diameter to a total number of floret portions (the ratio of floret portions) is at least 40%, when the diameter of a whole head is 14.0 cm to 17.0 cm. The genetic structure that confers such traits is unknown. The only structure described in the specification is that which is present in the broccoli plants with seed deposited of broccoli lines SSC-BRO-22-001, SSC-BRO-22-002, and SSC-BRO-22-003, deposited under accession numbers FERM BP-22456, FERM BP-22457, and FERM BP-22458. It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (AbbVie, 759 F.3d at 1298, reiterating Enzo Biochem, Inc., 323 F.3d at 964)(emphasis added). However, in the instant application, there is insufficient evidence of such an established structure-function correlation.
Since the specification fails to adequacy describe broccoli plants as broadly claimed, F1 plants produced from said plants and methods that employ with said plants are similarly not described.
Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Conclusion
No claim is allowed.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662