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 .
Status of the Claims
Claims 1-20 were originally filed July 3, 2023.
Claims 1-20 are currently pending.
Claims 1, 3, and 4 are currently under consideration.
Election/Restrictions
Applicant’s election of Group I (claims 1-4 and 9-13) in the reply filed on July 6, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 5-8 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected polynucleotide and a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 6, 2026.
Applicant’s election of Cry1Ia10, Cry2Ab1, chitinase, and endochitinase as the species in the reply filed on July 6, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2 and 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 6, 2026.
Potential Rejoinder
Applicant elects claims directed to the product of a composition comprising polypeptides. If the product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a CIP of PCT/IL2022/050015 filed January 4, 2022 which claims the benefit of 63/133,437 filed January 4, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 5, 2023 is being considered by the examiner.
Drawings
The drawings are objected to because Figure 1 is illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See paragraph 129.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 3 and 4 are objected to because of the following informalities: chitinase and endochitinase do not require capitalization. Appropriate correction is required.
Claims 3 and 4 are objected to because of the following informalities: a comma is not necessary since only two members are present. Appropriate correction is required.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Claim Rejections - 35 USC § 112
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, and 4 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. One of skill in the art would not be able to determine the scope of the present composition. For example, it is unclear what the scope of “set forth in” is (e.g. open, closed, etc.).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to Bacillus thuringiensis cry proteins Cry1Ia10, Cry2Ab1, chitinase, and/or endochitinase without significantly more. The claims recite Cry1Ia10 and Cry2Ab1 alone or in combination with chitinase and/or endochitinase. This judicial exception is not integrated into a practical application because the present claims are drawn to the composition only. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because all of the proteins in the claims (i.e. Cry1Ia10, Cry2Ab1, chitinase, and endochitinase) are made by Bacillus thuringiensis. See Bergamasco et al., 2013, Bacillus thuringiensis Cry1Ia10 and Vip3Aa protein interactions and their toxicity in Spodoptera spp. (Lepidoptera), Journal of Invertebrate Pathology, 112: 152-158 (Cry1Ia10); Jain et al., 2006, Cloning, Characterization, and Expression of a New cry2Ab gene From Bacillus thuringiensis Strain 14-1, Applied Biochemistry and Biotechnology, 128: 185-194 (Cry2Ab1); and de la Fuente-Salcido et al., 2016, The endochitinase ChiA Btt of Bacillus thuringiensis subsp. tenebrionis DSM-2803 and its potential use to control the phytopathogen Colletotrichum gloeosporioides, Microbiology Open, 5(5): 819-829.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barrett et al. U.S. Patent Application Publication 2019/0390219 published December 26, 2019.
For present claim 1, Barrett et al. teach compositions comprising Bacillus thuringiensis cry proteins including Cry1, Cry2, Cry1Ia10, and Cry2Ab1 (please refer to the entire specification particularly the abstract; paragraphs 5, 222-224, ). Barrett et al. only teaches a chitinase promoter and not a chitinase protein (please refer to the entire specification particularly paragraphs 178, 221).
Therefore, the teachings of Barrett et al. anticipate the presently claimed composition.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kennedy et al. U.S. Patent Application Publication 2020/0255481 published August 13, 2020.
For present claims 1 and 3, Kennedy et al. teach compositions comprising Bacillus thuringiensis cry proteins including Cry1, Cry2, Cry1Ia10, and Cry2Ab1 and chitinase (please refer to the entire specification particularly the abstract; paragraphs 6, 15, 16, 24, 26, 53, 65, 80, 81, 155, 176, 255, 261, 507, 517, 521, 532, 536, 559, 572, 587-590, 605, 633, 636, 674, 678, 693, 697, 709, 710, 713, 719, 738, 792-808, 844-848, 856-864; Tables 4 and 7; claims).
Therefore, the teachings of Kennedy et al. anticipate the presently claimed composition.
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.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Barrett et al. U.S. Patent Application Publication 2019/0390219 published December 26, 2019 and Thompson et al. WO 2017/161181 published September 21, 2017 (due to the large size of the document, only relevant pages are provided).
For present claims 1, 3, and 4, Barrett et al. teach compositions comprising Bacillus thuringiensis cry proteins including Cry1, Cry2, Cry1Ia10, and Cry2Ab1 (please refer to the entire specification particularly the abstract; paragraphs 5, 222-224, ). Barrett et al. only teaches a chitinase promoter and not a chitinase protein (please refer to the entire specification particularly paragraphs 178, 221).
For present claims 1, 3, and 4, Thompson et al. teach compositions comprising Bacillus thuringiensis cry proteins including Cry1, Cry2, and chitosen, endochitosan, and exochitisan (please refer to the entire specification particularly the abstract; paragraphs 8, 55, 68, 210-213, 237-247, 334-338, 393, 425-427, 444, 450, 451, 536-538).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. specific combination of proteins in a composition) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of chitinase) for another (i.e. subgenus of endochitinase) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. combining cry1, cry2, chitinase, and endochitinase) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy et al. U.S. Patent Application Publication 2020/0255481 published August 13, 2020 and Thompson et al. WO 2017/161181 published September 21, 2017 (due to the large size of the document, only relevant pages are provided).
For present claims 1, 3, and 4, Kennedy et al. teach compositions comprising Bacillus thuringiensis cry proteins including Cry1, Cry2, Cry1Ia10, and Cry2Ab1 and chitinase (please refer to the entire specification particularly the abstract; paragraphs 6, 15, 16, 24, 26, 53, 65, 80, 81, 155, 176, 255, 261, 507, 517, 521, 532, 536, 559, 572, 587-590, 605, 633, 636, 674, 678, 693, 697, 709, 710, 713, 719, 738, 792-808, 844-848, 856-864; Tables 4 and 7; claims).
For present claims 1, 3, and 4, Thompson et al. teach compositions comprising Bacillus thuringiensis cry proteins including Cry1, Cry2, and chitosen, endochitosan, and exochitisan (please refer to the entire specification particularly the abstract; paragraphs 8, 55, 68, 210-213, 237-247, 334-338, 393, 425-427, 444, 450, 451, 536-538).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. specific combination of proteins in a composition) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of chitinase) for another (i.e. subgenus of endochitinase) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. combining cry1, cry2, chitinase, and endochitinase) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent 6,503,500
U.S. Patent Application Publication 2019/0292543
KR 20200127180
KR20200385711
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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