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. The Office acknowledges the receipt of Applicant’s amendment filed December 3, 2025. Claims 1-19 are pending and are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Claim Objections
2. Claims 11 and 13 are objected to because of the following:
In claim 11(c), “a recurrent parent in step (a)” should be amended to “the recurrent parent in step (a)”.
In claim 13, “a plant of claim 1” should be amended to “the plant of claim 1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
3. Claim 12 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 pre-AIA the applicant regards as the invention.
In claim 12, “the recurrent strawberry variety” lacks antecedence. Is Applicant referring to the recurrent plant of step (a)?
Clarification and/or correction is required.
Applicant does not address this rejection.
Accordingly, the rejection is maintained.
Double Patenting
4. Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of U.S. Patent No. PP36347. This is a statutory double patenting rejection. Claim 1 of the instant application is directed to the same plant as claim 1 of the issued parent.
Applicant’s Traversals
Applicant traverses primarily that these claims are not identical in scope. Claim 1 of the instant application is defined by 35 USC 271 which grants the utility patent owner the right to exclude others from making, using, offering to sell, selling, or importing the patented invention. Claim 1 of the PP patent is defined by 35 USC 163 which includes the right to exclude others from asexually reproducing the plant, and from using, offering for sale, or selling the plant so produced, or any of its parts, throughout the US, or from importing the plant so reproduced, or any parts thereof, into the US. Because the PP claim 1 encompasses the plant or any of its parts, whereas claim 1 of the instant application does not, they differ in scope.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive. 35 USC 101 states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Two US patents cannot issue from the same invention, regardless of the US statute that specifies the type of protection after a patent has issued. MPEP 804 (“Design/Plant – Utility Situations”) states “Double patenting issues may be raised where an applicant has filed both a utility patent application (35 U.S.C. 111) and either an application for a plant patent (35 U.S.C. 161) or an application for a design patent (35 U.S.C. 171). In general, the same double patenting principles and criteria that are applied in utility-utility situations are applied to utility-plant or utility-design situations. Double patenting rejections in utility-plant situations may be made in appropriate circumstances.” (emphasis added). Claim 1 in both the instant application and the referenced PP patent are directed to a plant of variety ‘FL 20.34-183’. Claim 1 of the referenced PP patent recites “A new and distinct strawberry plant named ‘FL 20.34-183’ as illustrated and described herein.” Only the plant is claimed in the PP patent. Applicant is invited to review PP31912 (A), which recites “A new and distinct variety of grapevine name ‘SV27-104-114’, and parts thereof, substantially as illustrated and described herein.” In contrast to the referenced PP patent, claim 1 of the PP31912 patent is directed to both the plant and parts thereof. Thus, claim 1 of the instant application and claim 1 of the referenced PP patent are identical in scope. Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 112(a)
5. Claims 2-6 and 14-18 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.
Claims 2-6 lack adequate written description for the following reasons. These claims encompass polyhaploid (from an octoploid genome) pollen, anther and ovule, and/or F1 progeny embryo and F1 seed of variety FL 20.34-183. Paragraph [0036] of the Specification discloses variety FL 20.34-183 is obtained from crossing FL 1.24-18 (female) with FL 17.17-127 (male). Thus, variety FL 20.34-183 is a hybrid, whereby its genome is heterologous at every locus. When the genome segregates to form polyhaploid pollen, anther and ovule cells, it is highly unpredictable which combinations of alleles from each of the genes in the strawberry genome are present in the polyhaploid cells. During meiosis to produce the polyhaploid cells, it is unpredictable which reassortment of dominant and recessive alleles of hybrid strawberry FL 20.34-183 would be present in the polyhaploid cells. One skilled in the art cannot predict the genetic makeup of the claimed pollen, anther and ovule. Additionally, when FL 20.34-183 is crossed with an unknown parent, it is unpredictable what genetic material its F1 progenies would inherit. The specification does not disclose a representative number of F1 progenies of the deposited hybrid to allow one skilled in the art to predict the genetic makeup or physiological and morphological characteristics of the claimed F1 progenies. No identifying characteristics are set forth for the F1 progenies. There are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine the genomic structure or morphological and physiological characteristics of the claimed F1 progenies, absent further guidance. Accordingly, the claimed polyhaploid plant parts, F1 progeny embryo and F1 seed lack adequate written description.
With regard to claim 14, it is unpredictable what morphological and physiological characteristics of variety FL 20.34-183 are present in the claimed plant subsequent to genetic transformation. The claim is not limited to a single transformation event, and each transformation event can add, alter and/or delete morphological and physiological characteristics of variety FL 20.34-183. It is suggested claim 14 be amended to recite that the claimed plant comprises the trait and all the morphological and physiological characteristics of variety FL 20.34-183.
With regard to claims 15-18, the claims do not indicate how the transgene or single locus conversion is introduced into hybrid variety FL 20.34-183. The specification utilizes the terms “transgene” and “single locus conversion” interchangeably [0083]. The recitation of “one or more genes” in paragraph [0009] indicates that Applicant intends to encompass more than one transgene or single locus conversion. Thus, the claims encompass the introduction of any number of transgenes or single locus conversions by any means, including by outcrossings with undisclosed plants. Variety FL 20.34-183 is a hybrid, whereby its genome is heterologous at every locus. Outcrossing of hybrid strawberry variety FL 20.34-183 with an undisclosed parent, then backcrossing to hybrid strawberry variety FL 20.34-183, would not regain all or most the morphological and physiological characteristics of hybrid strawberry variety FL 20.34-183 due to the presence of heterologous dominant and recessive alleles at every locus of the genome. The recurrent parent (variety FL 20.34-183) goes through meiosis to produce polyhaploid pollen or ovule, and the resulting genome is not the same as the genome of hybrid strawberry variety FL 20.34-183. Thus, it is not known what physiological and morphological characteristics of strawberry variety FL 20.34-183 are retained after said outcrossings, as outcrossings with genetically different plants would introduce characteristics which are not present in variety FL 20.34-183 in addition to the transgenes or single locus conversions. Aside from the traits introduced by the transgenes or single locus conversions, the resulting plant is likely have morphological and physiological characteristics which are significantly different from those disclosed for hybrid variety FL 20.34-183. However, it is not known what those characteristics are or how they differ from hybrid variety FL 20.34-183. Thus, the claimed plants obtained by any method of introducing a transgene or single locus conversion into hybrid variety FL 20.34-183 are not adequately described.
Accordingly, the claimed invention lacks adequate written description under current written description guidelines https://www.uspto.gov/sites/default/files/web/menu/written.pdf.
Applicant’s Traversals
Applicant traverses primarily the following: (1) Claim 2 has been amended to recite at least one cell of said strawberry plant of variety ‘FL 20.34-183’. (2) In Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 63 USPQ2d (Fed. Cir. 2002)("Enzo") "reference in the specification to a deposit in a public depository, which makes its contents accessible to the public when it is not otherwise available in written form, constitutes an adequate description of the deposited material sufficient to comply with the written description requirement of § 112, 1." (3) The specification provides guidance to a person having ordinary skill in the art in introducing a transgene or a single locus conversion into a strawberry plant of strawberry variety 'FL 20.34-183'; and a skilled strawberry breeder may obtain a molecular profile of strawberry variety 'FL 20.34-183' based upon the representative sample of said deposited variety, and use said molecular profile to identify a strawberry plant of strawberry variety 'FL 20.34-183' further comprising a transgene or a single locus conversion.
Response to Applicant’s Traversals
Applicant’s traversals are unpersuasive for the following reasons. With regard to traversal (1), the recitation of “at least one cell of said strawberry plant” encompasses progeny embryo and seed cell, as well as polyhaploid pollen, anther and ovule cells, present as part of said strawberry plant. These are all cells of said strawberry plant. It is suggested claim 2 be amended to recite “at least one variety ‘FL 20.34-183’ cell.” With regard to traversal (2), the statute 35 USC 112(a) clearly states “The specification shall contain a written description of the invention” (emphasis added). No interpretation of case laws, including Enzo, is required. Moreover, the claimed pollen, anther and ovule, F1 progeny embryo and F1 seed of variety ‘FL 20.34-183’ are not deposited. With regard to traversal (3), Applicant is arguing enablement when this is a written description rejection. The claimed plants are not deposited. A molecular profile of strawberry variety 'FL 20.34-183', which is not disclosed, is not representative of the plants of claims 14-18, because these plants are genotypically and phenotypically distinct from the deposited variety. Outcrossing of hybrid variety ‘FL 20.34-183’ to introduce a transgene or single locus conversion, even with backcrossings to hybrid variety ‘FL 20.34-183’, would produce plants that have significantly different traits from those disclosed for hybrid variety ‘FL 20.34-183’. Additionally, paragraph [0064] states that variant traits can occur during backcrossing, introduction of a transgene or application of a genetic engineering technique. Accordingly, the rejection is maintained.
In claim 14, it is suggested the claim be amended to recite that the claimed plant has the added trait and all the morphological and physiological characteristics of variety 'FL 20.34-183'. In claims 15 and 17, it is suggested that the claims be amended to recite the method(s) utilized to introduce the transgene or single locus conversion that would retain all the morphological and physiological characteristics of variety 'FL 20.34-183', e.g., transformation or site-directed editing, and recite that the claimed plant has the transgene / single locus conversion and all the morphological and physiological characteristics of variety 'FL 20.34-183'.
Conclusion
6. Claims 1-6, 12 and 14-18 are rejected. Claims 7-11, 13 and 19 are objected to for the reasons set forth above, or they depend from a rejected claim.
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Phuong Bui whose telephone number is 571-272-0793.
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 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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/PHUONG T BUI/Primary Examiner, Art Unit 1663