Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim status
Claims 1-5 are examined.
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 1-3 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.
The applicant recites the limitation “amplification and intensification” in claim 1, line 7, claim 2 (e) and claim 3 (b). This limitation is indefinite because it is not clear what would read on a probe detecting amplification in absence of intensification. Applicant has provided observation of the Ban-1 probe by Southern blot reveals “activation of retro-transposable elements and intensification of the elements in specific loci” (see Figure 7 and description below). Applicant provides that the Ban-1 probe, is an RT-specific probe comprising a portion of the gene encoding the reverse transcriptase of Copia 1 retro-transposable element with the sequence of SEQ ID NO: 1 (page 8). It is not clear how this probe, which appears to be qualitative, would provide whether an RT has been activated and intensified.
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Written Description
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 1-5 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.
Applicant claims a banana plant resistant to Fusarium oxysporum Cubensis TR4 wherein the resistance is associated with at least one genomic marker associated with the resistance trait which has a banding pattern detectable by Southern blot using the Ban-1 probe revealing activation and intensification of RT elements in loci associated with the resistance trait. Applicant claims methods of producing the resistant banana plant including a step of selecting for presence of a marker associated with FOC4 resistance observed by Southern blot analysis (see for example, claim 2, parts (e) and (f), after selecting for resistance to FOC4 (see for example, claim 2, part (d).
Applicant describes exposing a batch of 4500 and 5200 banana plants to a demethylating agent to cause mutagenesis. Applicant describes in vitro identification of 153 and 262 individual plants from the populations of 4500 and 5200 plants, respectively, as being resistant to Fusarium oxysporum Cubensis TR4 (FOC4) by observing the plants to be asymptomatic following inoculation to the fungi’s spores in vitro (page 10, paragraph 2).
Applicant describes mutating cells cloned from GAL cultivar with a demethylating agent (page 10, lines 13-18). Applicant describes separating clones from the 24th propagation cycle to be planted in a commercial field in Israel and to be screened for resistance at Wageningen University in pots, observing 153 plants as being asymptomatic (page 11, paragraph 2; page 12, paragraph 1). Applicant describes visual differences in plants being demonstrated in Figures 2A-E, Figure 3, Figure 4, Figures 5G-5H, Figures 6A-6G. Applicant describes Figure 7 as showing a Southern blot hybridization from the Ban-1 probe, which Applicant describes as a RT specific probe comprising a portion of the gene encoding the reverse transcriptase of Copia 1 retro-transposable element with the sequence of SEQ ID NO: 1 (page 8).
The described embodiments are not representative of the breadth of the claimed genus such that one of ordinary skill in the art would be able to envision which members of the claimed genus possess the claimed function. Applicant does not sufficiently describe a structure that would be recognized as providing the claimed function. One of ordinary skill in the art would not have been able to envision which members of the claimed genera would comprise FOC4 resistance. Regarding the results demonstrated in Figures 2A-E, Figure 3, Figure 4, Figures 5G-5H, Figures 6A-6G, it is not clear from these figures what differences exist in the plants pictured. Regarding Figure 7, it is not clear how one of ordinary skill in the art would differentiate between a banana plant generically comprising Copia 1 RT and a plant which has had this RT activated and intensified because the Southern blot hybridization appears to only demonstrate presence of Copia 1 RT qualitatively. Applicant may consider amending claims to incorporate a deposit representative of the claimed plant provided it is properly deposited. Limiting the claims to a deposited plant may overcome this rejection. The claimed method steps appear to indicate that selecting for presence of a genomic marker associated with FOC4 would not necessarily be achieved by selecting for resistance to FOC4. This indicates further that it would not be clear that selection for a marker as claimed would result in FOC4 resistance.
Given the breadth of the genera encompassed by the claims, the described species are not sufficiently representative.
Claim Rejections - 35 USC § 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 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 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Molina (Molina, et al. ISHS Acta Horticulturae 1114: XXIX International Horticultural Congress on Horticulture: Sustaining Lives, Livelihoods and Landscapes (IHC2014): IX International Symposium on Banana: ISHS-ProMusa Symposium on Unravelling the Banana's Genomic Potential. 227-230. 2016) in view of Khayat (Khayat et al. Banana Improvement: Cellular, Molecular Biology and Induced mutations. Chapter 9. Food and Agriculture Organization. 2004), Bucher (Bucher, et al. Current Opinion in Plant Biology. 15: 503-510. 2012), Madlung (Madlung et al. Plant Physiology. 129: 733-746. 2002) and AF416809 (Genbank Accession no. AF416809, submitted July 2016).
Claim 1 is drawn to a banana plant resistant to Fusarium oxysporum Cubensis TR4 wherein the resistance is associated with at least one genomic marker associated with the resistance trait which has a banding pattern detectable by Southern blot using the Ban-1 probe revealing activation and intensification of RT elements in loci associated with the resistance trait. Claims 2 and 3 are drawn to a method of producing the resistant banana plant comprising the steps of: a) exposing banana meristem to a demethylating agent, thereby activating a retro-transposable element; b) rooting the meristems to regenerate a banana plant with FOC TR4 resistance, c) testing for FOC4 resistance, d) selecting for FOC4 resistance, e) determining the presence of a genomic marker associated with resistance to FOC TR4 by Southern blot. Claims 4 and 5 are drawn to a banana plant comprising at least one genomic marker associated with the resistance trait which has a banding pattern detectable by Southern blot using the Ban-1 probe.
Molina teaches a banana plant with tolerance to Fusarium oxysporum Cubensis TR4 and a method of producing the plant by selection of somaclonal variants of banana (page 228, paragraph 2; table 1). Molina teaches Banana plants were grown from tissue culture (page 228, paragraph 4) which one of ordinary skill in the art would recognize to implicitly encompass rooting the meristem that exhibited resistance and regenerating one or more banana plants.
Molina does not teach activation and intensification of a retrotransposable element.
Molina does not teach exposing the meristem to the demethylating agent.
The banana plant provided by Molina would inherently comprise a genomic marker associated with the plant’s FOC TR4 resistance; however, regarding a sequence that would be detected by the Ban-1 probe, it is not clear if the plant of Molina comprises the Copia 1 RT, i.e., would have a locus detectable by the Ban-1 probe.
Molina does not teach Southern blot hybridization conducted with an RT-specific probe, Ban-1.
Khayat teaches somaclonal variants are due to the activation of a retrotransposable element (abstract). Khayat teaches detection of retro-transposable elemenst in somaclonal variants of Banana with Southern blot using Ban-1 probe (Figure 7 and 8).
Bucher teaches that it was known in the art that retro-transposable elements are regulated by methylation (page 503, right column, paragraph 2) and that DNA demethylation activates retro-transposable elements (page 506, left column, paragraph 3).
Madlung teaches exposing a plant to decitabine as a demethylating agent (page 733, right column, paragraph 2).
AF416809 teaches a banana plant comprising the RT which applicant teaches is detectable by the Ban-1 probe (see alignment below; Specification, page 8).
It would have been obvious to modify the method of inducing somaclonal variation of Molina to include demethylation as taught by Bucher and using a demethylation agent as taught by Madlung because inducing somaclonal variation in banana has been found to successfully produce variation which is resistant to Fusarium oxysporum Cubensis TR4. It would have been obvious to substitute the starting banana plant of Molina with the banana plant of AF416809 as a design choice. Because RTs were known to cause somaclonal variation, that demethylation activates RTs and the starting material comprises the sequence detectable by the Ban-1 probe, one of ordinary skill in the art would expect to detect the RT of the banana plant with the Ban-1 probe. This is interpreted as reading on the RT being activated and intensified.
Alignment of instant SEQ ID NO: 1 to AF416809:
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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 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.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12082544. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 is drawn to a banana plant resistant to Fusarium oxysporum Cubensis TR4 wherein the resistance is associated with at least one genomic marker associated with the resistance trait which has a banding pattern detectable by Southern blot using the Ban-1 probe revealing activation and intensification of RT elements in loci associated with the resistance trait. Instant claims 2 and 3 are drawn to a method of producing the resistant banana plant comprising the steps of: a) exposing banana meristem to a demethylating agent, thereby activating a retro-transposable element; b) rooting the meristems to regenerate a banana plant with FOC TR4 resistance, c) testing for FOC4 resistance, d) selecting for FOC4 resistance, e) determining the presence of a genomic marker associated with resistance to FOC TR4 by Southern blot. Instant claims 4 and 5 are drawn to a banana plant comprising at least one genomic marker associated with the resistance trait which has a banding pattern detectable by Southern blot using the Ban-1 probe.
Claims 1-9 of ‘544 are drawn to a method for producing a banana plant resistant to FOC4 comprising the steps of: exposing banana meristem to a demethylating agent, thereby activating a retro-transposable element; rooting the meristems to regenerate a banana plant with FOC TR4 resistance, testing for FOC4 resistance and determining the presence of a genomic marker associated with resistance to FOC TR4 by Southern blot. Therefore, the claims of ‘544 read on the instantly claimed methods and make obvious a FOC4-resistant banana plant produced by the method
Conclusion
Claims 1-5 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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/DAVID R BYRNES/Examiner, Art Unit 1662