DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/18/2026 has been entered.
3. Applicant’s amendment to the claims filed on 03/18/2026 in response to the Final Rejection mailed on 11/26/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
4. Claims 8, 13, 16-17, 24, and 27-28 are cancelled.
4. New claims 29-32 are added.
5. Claims 18-23 and 29-32 are pending.
6. Claims 20-23 stand withdrawn pursuant to 37 CFR 1.142(b).
7. Applicant’s remarks filed on 03/18/2026 in response to the Final Rejection mailed on 11/26/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Information Disclosure Statement
8. The IDSs filed on 11/21/2025 and 02/05/2026 have been considered by the examiner and copies of the Form PTO/SB/08 are attached to the office action.
Claim Rejections - 35 USC § 103
9. The rejection of claims 8, 13, 16-17, and 27-28 under 35 U.S.C. 103 as being unpatentable over Thompson et al. (US Patent Application Publication 2016/0108096; cited on IDS filed on 05/31/2024) in view of Kyung et al. (KR 20110069968, 06/24/2011, cited on PTO-892 mailed on 11/16/2025) is withdrawn in view of applicants’ amendment to the claims to cancel claims 8, 13, 16-17, and 27-28.
10. The rejection of claims 18-19 under 35 U.S.C. 103 as being unpatentable over Thompson et al. (US Patent Application Publication 2016/0108096; cited on IDS filed on 05/31/2024) in view of Kyung et al. (KR 20110069968, 06/24/2011, cited on PTO-892 mailed on 11/16/2025) is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in order to address applicants’ amendment to the claims and to incorporate new claims 29-32.
Claims 18-19 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson et al. (US Patent Application Publication 2016/0108096; cited on IDS filed on 05/31/2024) in view of Kyung et al. (KR 20110069968, 06/24/2011, cited on PTO-892 mailed on 11/16/2025).
11. As amended, claims 18 and 31-32 are drawn to a seed coating formulation comprising a recombinant Bacillus cereus family member and an agriculturally acceptable carrier, wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising: (A) a targeting sequence, exosporium protein, or exosporium protein fragment that targets the fusion protein to the exosporium of a recombinant Bacillus cereus family member; and (B) an enzyme, wherein the enzyme comprises an amino acid sequence having at least 95% identity to SEQ ID NO: 300.
Claims 19 and 30 are drawn to a seed coating formulation comprising exosporium fragments derived from a recombinant Bacillus cereus family and an agriculturally acceptable carrier, wherein wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising: (A) a targeting sequence, exosporium protein, or exosporium protein fragment that targets the fusion protein to the exosporium of a recombinant Bacillus cereus family member; and (B) an enzyme, wherein the enzyme comprises an amino acid sequence having at least 95% identity to SEQ ID NO: 300.
12. With respect to claims 18 and 19, Thompson et al. teach a seed coating formulation comprising a recombinant Bacillus cereus family member or exosporium fragments derived from a recombinant Bacillus cereus family member and an agriculturally acceptable carrier [see Abstract; paragraphs 0003-0008, 0028; 0621], wherein the recombinant Bacillus cereus family member expresses a fusion protein comprising a targeting sequence, an exosporium protein, or an exosporium protein fragment that targets the fusion protein to the exosporium of a Bacillus cereus family member fused to a protein of interest such as an enzyme, wherein the peptide of interest can be an enzyme such as a cellulase and wherein the proteins can be used in a variety of process such as industrial cleaning [see Abstract; paragraphs 0003-0008; paragraphs 0806, 0847, 0874-0875; 0990]. Thompson et al. teach the fusion protein wherein the enzyme is from a Bacillus, such as Bacillus licheniformis, or Paenibacillus [see paragraphs 0641 and 0650]. Thompson et al. teach that expression of these enzymes allows for resistance to harsh conditions [see paragraph 0981].
However, Thompson et al. does not teach the seed coating formulation fusion protein of claims 18 and 19, wherein the enzyme comprises an amino acid sequence having at least 95% identity to SEQ ID NO: 300; the seed coating formulation of claims 29 and 30, wherein the enzyme comprises an amino acid sequence having at least 95%, at least 98%, at least 99%, or 100% identity to SEQ ID NO: 300; the seed coating formulation of claim 31, wherein the fusion protein comprises a signal peptide; and the seed coating formulation of claim 32, wherein the signal peptide comprises SEQ ID NO: 340 at its amino terminus; or the signal peptide comprises SEQ ID NO: 339 at its amino terminus.
Kyung et al. teach cold-active cellulases from Bacillus that exhibit activity at low temperatures comprising an amino acid sequence that is 100% identical to SEQ ID NO: 300 and a signal peptide that is 100% identical to SEQ ID NO: 340 that is useful in the food, paper, and fermentation industries [see Abstract; p. 4 of translation and alignment attached as APPENDIX A].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Thompson et al. and Kyung et al. to fuse the cellulase of Kyung et al. to the exosporium proteins of Thompson et al. because Thompson et al. teach fusion proteins comprising cellulases for industrial cleaning compositions. Kyung et al. teach cold-active cellulases from Bacillus that exhibit activity at low temperatures comprising an amino acid sequence that is 100% identical to SEQ ID NO: 300 and a signal peptide that is 100% identical to SEQ ID NO: 340 that is useful in the food, paper, and fermentation industries. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability and would have been motivated to combine the teachings of Thompson et al. and Kyung et al. because Kyung et al. acknowledges these cellulases are useful in the food, paper, and fermentation industries where low temperatures are necessary. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Remarks Regarding Prior Art Rejections
13. Beginning on p. 4 of applicants’ remarks, applicants in summary contend that there is simply no teaching, suggestion, or motivation to combine the documents to make and use the seed formulations as recited in the claims and the Office has not provided an articulate reasoning that one of ordinary skill in the art would have combined Thompson with Kyung out of the numerous cellulases to choose from.
These arguments are found to be not persuasive because MPEP 2143 states “[t]he Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. In Ball Aerosol v. Ltd. Brands, 555 F.3d 984, 89 USPQ2d 1870 (Fed. Cir. 2009), the Federal Circuit offered additional instruction as to the need for an explicit analysis. The Federal Circuit explained that the Supreme Court’s requirement for an explicit analysis does not require record evidence of an explicit teaching of a motivation to combine in the prior art. Examples of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.”
In the instant case and as stated in the rejection above, Thompson et al. teach that expression of these enzymes in seed formulations allows for resistance to harsh conditions such as those in food or beverage processing, fermentation, starch treatment, etc. [see paragraphs 0979-0981]. Kyung et al. teach cold-active cellulases from Bacillus that exhibit activity at low temperatures comprising an amino acid sequence that is 100% identical to SEQ ID NO: 300 and a signal peptide that is 100% identical to SEQ ID NO: 340 that is useful in the food, paper, and fermentation industries. Thus using a KSR approach of combining prior art elements according to known methods to yield predictable results and simple substitution of one known element for another to obtain predictable results, one of ordinary skill in the art with the teachings of Thompson et al. in hand would look to the teachings of Kyung et al. for cellulases active at low temperature (harsh condition) to combine the in seed formulations of Thompson et al.
Beginning on p. 7 of applicants’ remarks, applicants in summary repeat prior arguments that the claimed seed coating formulations yield unexpected results to stimulate plant growth.
This argument is found to be not persuasive because MPEP 2145.II states “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.).”
Even assuming arguendo, that increased plant growth is an unexpected result, this argument is found to be not persuasive because the argument of unexpected results must be commensurate in scope with the claimed invention. MPEP 716.02(d) states “whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. In the instant case, the alleged unexpected result occurred in corn, whereas the claims are unlimited to the type of plant, and there is no evidence of record that the alleged unexpected property would occur over all plants as encompassed by the claims.
Double Patenting
14. The nonstatutory double patenting rejection of claims 8, 13, 16-17 and 27-28 over claims 1-27, 52-57, 70-78, 86-117, and 138-148 of U.S. Patent No. 9,845,342 in view of Kyung et al. (KR 20110069968, 06/24/2011, cited on PTO-892 mailed on 11/16/2025) is withdrawn in view of applicants’ amendment to the claims to cancel claims 8, 13, 16-17 and 27-28.
15. The nonstatutory double patenting rejection of claims 8, 13, 16-17 and 27-28 over claims 1-14, 18-19, and 32-34 U.S. Patent No. 10,836,800 in view of Kyung et al. (KR 20110069968, 06/24/2011, cited on PTO-892 mailed on 11/16/2025) is withdrawn in view of applicants’ amendment to the claims to cancel claims 8, 13, 16-17 and 27-28.
16. The nonstatutory double patenting rejection of claims 18-19 over claims 1-27, 52-57, 70-78, 86-117, and 138-148 of U.S. Patent No. 9,845,342 in view of Kyung et al. (KR 20110069968, 06/24/2011, cited on PTO-892 mailed on 11/16/2025) is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in order to incorporate new claims 29-32, which is necessitated by applicants’ amendment to the claims.
Claims 18-19 and 29-32 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-27, 52-57, 70-78, 86-117, and 138-148 of U.S. Patent No. 9,845,342 in view of Kyung et al. (KR 20110069968, 06/24/2011, cited on PTO-892 mailed on 11/16/2025).
Claims 1-27, 52-57, 70-78, 86-117, and 138-148 recite a recombinant Bacillus cereus family member that expresses a fusion protein comprising: at least one protein or peptide of interest; a targeting sequence, exosporium protein, or exosporium protein fragment that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member; and an amino acid linker between the targeting sequence, the exosporium protein, or the exosporium protein fragment and the protein or peptide of interest, wherein the linker comprises a polyalanine linker, or polyglycine linker, or a linker comprising a mixture of both alanine and glycine resides; and wherein the recombinant Bacillus cereus family member comprises a mutation that results in Bacillus cereus family member spores having an exosporium that is easier to remove from the spore as compared to the spore of a wile-type spore.
However, the claims of the ‘342 patent do not recite the seed coating formulation fusion protein of claims 18 and 19, wherein the enzyme comprises an amino acid sequence having at least 95% identity to SEQ ID NO: 300; the seed coating formulation of claims 29 and 30, wherein the enzyme comprises an amino acid sequence having at least 95%, at least 98%, at least 99%, or 100% identity to SEQ ID NO: 300; the seed coating formulation of claim 31, wherein the fusion protein comprises a signal peptide; and the seed coating formulation of claim 32, wherein the signal peptide comprises SEQ ID NO: 340 at its amino terminus; or the signal peptide comprises SEQ ID NO: 339 at its amino terminus.
Kyung et al. teach cold-active cellulases from Bacillus that exhibit activity at low temperatures comprising an amino acid sequence that is 100% identical to SEQ ID NO: 300 and a signal peptide that is 100% identical to SEQ ID NO: 340 that is useful in the food, paper, and fermentation industries [see Abstract; p. 4 of translation and alignment attached as APPENDIX A].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the recitations of the ‘342 patent and Kyung et al. to fuse the cellulase of Kyung et al. to the exosporium proteins of the ‘342 patent because the ‘342 patent recite fusion proteins for industrial cleaning compositions. Kyung et al. teach cold-active cellulases from Bacillus that exhibit activity at low temperatures comprising an amino acid sequence that is 100% identical to SEQ ID NO: 300 and a signal peptide that is 100% identical to SEQ ID NO: 340 that is useful in the food, paper, and fermentation industries. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability and would have been motivated to combine the recitations of the ‘342 patent and Kyung et al. because Kyung et al. acknowledges these cellulases are useful in the food, paper, and fermentation industries where low temperatures are necessary. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
17. The nonstatutory double patenting rejection of claims 18-19 over claims 1-14, 18-19, and 32-34 U.S. Patent No. 10,836,800 in view of Kyung et al. (KR 20110069968, 06/24/2011, cited on PTO-892 mailed on 11/16/2025) is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in order to incorporate new claims 29-32, which is necessitated by applicants’ amendment to the claims.
Claims 18-19 and 29-32 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-14, 18-19, and 32-34 U.S. Patent No. 10,836,800 in view of Kyung et al. (KR 20110069968, 06/24/2011, cited on PTO-892 mailed on 11/16/2025).
Claims 1-14, 18-19, and 32-34 recite a recombinant Bacillus cereus family member that expresses a fusion protein comprising: at least one protein or peptide of interest; a targeting sequence, exosporium protein, or exosporium protein fragment that targets the fusion protein to the exosporium of the recombinant Bacillus cereus family member; and an amino acid linker between the targeting sequence, the exosporium protein, or the exosporium protein fragment and the protein or peptide of interest, wherein the linker comprises a polyalanine linker, or polyglycine linker, or a linker comprising a mixture of both alanine and glycine resides; and wherein the recombinant Bacillus cereus family member comprises a mutation that results in Bacillus cereus family member spores having an exosporium that is easier to remove from the spore as compared to the spore of a wile-type spore.
However, the claims of the ‘342 patent do not recite the seed coating formulation fusion protein of claims 18 and 19, wherein the enzyme comprises an amino acid sequence having at least 95% identity to SEQ ID NO: 300; the seed coating formulation of claims 29 and 30, wherein the enzyme comprises an amino acid sequence having at least 95%, at least 98%, at least 99%, or 100% identity to SEQ ID NO: 300; the seed coating formulation of claim 31, wherein the fusion protein comprises a signal peptide; and the seed coating formulation of claim 32, wherein the signal peptide comprises SEQ ID NO: 340 at its amino terminus; or the signal peptide comprises SEQ ID NO: 339 at its amino terminus.
Kyung et al. teach cold-active cellulases from Bacillus that exhibit activity at low temperatures comprising an amino acid sequence that is 100% identical to SEQ ID NO: 300 and a signal peptide that is 100% identical to SEQ ID NO: 340 that is useful in the food, paper, and fermentation industries [see Abstract; p. 4 of translation and alignment attached as APPENDIX A].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the recitations of the patent and Kyung et al. to fuse the cellulase of Kyung et al. to the exosporium proteins of the ‘800 patent because the ‘800 patent recite fusion proteins for industrial cleaning compositions. Kyung et al. teach cold-active cellulases from Bacillus that exhibit activity at low temperatures comprising an amino acid sequence that is 100% identical to SEQ ID NO: 300 and a signal peptide that is 100% identical to SEQ ID NO: 340 that is useful in the food, paper, and fermentation industries. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability and would have been motivated to combine the recitations of the ‘800 patent and Kyung et al. because Kyung et al. acknowledges these cellulases are useful in the food, paper, and fermentation industries where low temperatures are necessary. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Applicants’ remarks traversing the double patenting rejections have been fully considered by the examiner; however, they are found to be not persuasive for the reasons set forth above regarding Kyung et al.
Conclusion
18. Status of the claims:
Claims 18-23 and 29-32 are pending.
Claims 20-23 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 18-19 and 29-32 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
APPENDIX A
Kyung et al. with SEQ ID NO: 300
Query Match 100.0%; Score 1287; Length 232;
Best Local Similarity 100.0%;
Matches 232; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ASSSNPSDKLYFKNKKYYIFNNVWGADQVSGWWQTIYHNSDSDMGWVWNWPSNTSTVKAY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ASSSNPSDKLYFKNKKYYIFNNVWGADQVSGWWQTIYHNSDSDMGWVWNWPSNTSTVKAY 60
Qy 61 PSIVSGWHWTEGYTAGSGFPTRLSDQKNINTKVSYSISANGTYNAAYDIWLHNTNKASWD 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PSIVSGWHWTEGYTAGSGFPTRLSDQKNINTKVSYSISANGTYNAAYDIWLHNTNKASWD 120
Qy 121 SAPTDEIMIWLNNTNAGPAGSYVETVSIGGHSWKVYKGYIDAGGGKGWNVFSFIRTANTQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SAPTDEIMIWLNNTNAGPAGSYVETVSIGGHSWKVYKGYIDAGGGKGWNVFSFIRTANTQ 180
Qy 181 SANLNIRDFTNYLADSKQWLSKTKYVSSVEFGTEVFGGTGQINISNWDVTVR 232
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SANLNIRDFTNYLADSKQWLSKTKYVSSVEFGTEVFGGTGQINISNWDVTVR 232
Kyung et al. with SEQ ID NO: 340
Query Match 100.0%; Score 148; Length 261;
Best Local Similarity 100.0%;
Matches 29; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKNNHLLKSILLWGAVCIIVLAGPLSAFA 29
|||||||||||||||||||||||||||||
Db 1 MKNNHLLKSILLWGAVCIIVLAGPLSAFA 29
Prosecution Insights