CTFR 18/018,094 CTFR 78386 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 This application is a 371 of PCT/EP2021/071058. The amendment filed on April 7, 2026 has been entered. Election/Restrictions Applicant elected Group I with a species election of (1) B. licheniformis as the cell host cell and (2) aprE promoter as the promoter in the reply filed on October 3, 2025. 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requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). 08-06 AIA Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 3, 2025 . 12-151 AIA 26-51 12-51 Status of Claims Claims 1-17 and 19-20 are pending. Claim 19 is withdrawn. Claims 1-17 and 20 are under examination. Response to Amendments/Arguments Claim Objections Applicant’s arguments, see page 6 of the Remarks, filed April 7, 2026, with respect to claims 1-2 and 16-17 have been fully considered and are persuasive. Claims 1-2 and 16-17 have been amended to italicize Bacillus. Therefore, the objection of claims 1-2 and 16-17 has been withdrawn . Claim Rejections - 35 USC § 112(b) Applicant’s arguments, see page 6 of the Remarks, filed April 7, 2026, with respect to claim 11 have been fully considered and are persuasive. Claim 11 has been amended to recite the reference rate. Therefore, the rejection of claim 11 under 35 U.S.C. 112(b) has been withdrawn . Applicant’s arguments, see page 6 of the Remarks, filed April 7, 2026, with respect to claim 18 have been fully considered and are persuasive. Claim 18 has been cancelled. Therefore, the rejection of claim 18 under 35 U.S.C. 112(b) has been withdrawn . Claim Rejections - 35 USC § 112(d) Applicant’s arguments, see page 6 of the Remarks, filed April 7, 2026, with respect to claim 18 have been fully considered and are persuasive. Claim 18 has been cancelled. Therefore, the rejection of claim 18 under 35 U.S.C. 112(d) has been withdrawn . Claim Rejections - 35 USC § 102 Applicant’s arguments, see page 6 of the Remarks, filed April 7, 2026, with respect to claims 1-2, 5-6, 8-13, and 16-18 have been fully considered and are persuasive. Claim 18 has been cancelled. Therefore, the rejection of claims 1-2, 5-6, 8-13, and 16-18 under 35 U.S.C. 102(a)(1) as being anticipated by Sun (An auto-inducible expression and high cell density fermentation of Beefy Meaty Peptide with Bacillus subtilis. Bioprocess Biosyst Eng. 2020 Apr;43(4):701-710 – form PTO-1449) has been withdrawn . Applicant’s arguments, see page 6 of the Remarks, filed April 7, 2026, with respect to claims 1, 3-4, 8, and 13-18 have been fully considered and are persuasive. Claim 18 has been cancelled. Therefore, the rejection of claims 1, 3-4, 8, and 13-18 under 35 U.S.C. 102(a)(1) as being anticipated by Stocks ( WO 2007/093179 – cited previously on form PTO-892) has been withdrawn . Claim Rejections - 35 USC § 103 Applicant’s arguments, see page 6 of the Remarks, filed April 7, 2026, with respect to claims 1-18 have been fully considered and are persuasive. Claim 18 has been cancelled. Therefore, the rejection of claims 1-18 under 35 U.S.C. 103 as being unpatentable over Sun (An auto-inducible expression and high cell density fermentation of Beefy Meaty Peptide with Bacillus subtilis. Bioprocess Biosyst Eng. 2020 Apr;43(4):701-710 – form PTO-1449), Rij (WO 2015/118126 – form PTO-1449), and Stocks ( WO 2007/093179 – cited previously on form PTO-892) has been withdrawn . Double Patenting 08-33 AIA 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. 08-35 AIA Claim s 1-17 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 and 3-14 of copending Application No. 18/018,112 (reference application), Rij (WO 2015/118126 – form PTO-1449), and Stocks ( WO 2007/093179 – cited previously on form PTO-892) . Although the claims at issue are not identical, they are not patentably distinct from each other because they are claiming common subject matter, as follows: The claims of the instant application and the claims of the reference application are directed to a method of producing a protein of interest in Bacillus licheniformis. Regarding claims 1 and 20 of the instant application, claim 1 of the reference application recites a method for cultivating a Bacillus host cell, comprising the steps of (a) inoculating a fermentation medium with a Bacillus host cell comprising an expression construct for a gene encoding a protein of interest; and (b1) cultivating for a first cultivation phase the Bacillus host cell in said fermentation medium under conditions conducive for the growth of the Bacillus subtilis host cell, wherein the cultivation of the Bacillus host cell comprises the addition of at least one feed solution and wherein the at least one feed solution provides a carbon source at increasing rates; and (b2) cultivating for a second cultivation phase the Bacillus host cell culture obtained in step (b1) under conditions conducive for the growth of the Bacillus subtilis host cell and the expression of the protein of interest, wherein the cultivation comprises the addition of at least one feed solution and wherein the at least one feed solution provides a carbon source at a constant rate, at decreasing rates or at rates increasing less than the rates in step (b1), wherein said constant rate or the starting rate of said decreasing rates or the starting rate of said rates increasing less than the rates in step (b) is below the maximum rate of the first cultivation phase. Regarding claim 2 of the instant application, claim 1 of the reference application recites obtaining the protein of interest. Regarding claim 5 of the instant application, claim 3 of the reference application recites that the increasing rates of step (b) are an exponentially increasing rates. Regarding claim 6 of the instant application, claim 4 of the reference application recites that the exponential rate has a factor of at least about 0.13h-1 and a starting amount of at least 1 g of the carbon source (Fig. 3). Regarding claim 7 of the instant application, claim 5 of the reference application recites that 50 g of a carbon source per kg of Bacillus host cell is present. Regarding claim 8 of the instant application, claim 6 of the reference application recites a first cultivation phase of 3h up to 48h. Regarding claim 9 of the instant application, claim 7 of the reference application recites that the feed solution of step (b2) is provided at a constant rate. Regarding claim 10 of the instant application, claim 1 of the reference application recites that the constant rate is below the maximum rate of the feeding rates of the first cultivation. Regarding claim 11 of the instant application, claim 8 of the reference application recites that the constant rate is within the rage of about 70% to about 20% (page 702, “The feeding strategies” and Fig. 3). Regarding claim 12 of the instant application, claim 9 of the reference application recites that the second cultivation is carried out for about 40h up to 120h. Regarding claim 13 of the instant application, claim 12 of the reference application recites that the cell culture is depleted from the carbon source after inoculation and prior to the first cultivation. Regarding claim 14 of the instant application, claim 11 of the reference application recites a first temperature for the first cultivation and a second temperature for the second cultivation (claim 1 ad pages 21-23). However, the claims of the reference application do not recite a promoter operably linked to the protein of interest, secretion of the protein of interest, temperature difference of about 3°C between the first and second temperatures, and introducing the gene encoding the protein of interest by genetic modification. Regarding claims 1 and 14 of the instant application, Stocks discloses a method for cultivating various Bacillus host cells (abstract, page 7, lines 25-34, and claim 1), comprising the steps of (a) inoculating a fermentation medium with a Bacillus host cell comprising an expression construct for a gene encoding a protein of interest (page 4, lines 1-26 and claim 1); and (b) cultivating for a first cultivation phase the Bacillus host cell in said fermentation medium under conditions conducive for the growth of the Bacillus host cell and the expression of the protein of interest (hyaluronan synthase) operably linked to a promoter, wherein the cultivation of the Bacillu s host cell comprises the addition of at least one feed solution and wherein the at least one feed solution provides a carbon source at increasing rates and at a first temperature (page 4, lines 1-26, page 5, lines 1-10, page 22, lines 19-24, and claim 1); and (c) cultivating for a second cultivation phase the Bacillus host cell culture obtained in step (b) under conditions conducive for the growth of the Bacillus host cell and the expression of the protein of interest, wherein the cultivation comprises a second temperature higher than the first temperature (page 4, lines 1-26, page 22, lines 19-24, and claim 1); wherein the expression construct comprises various inducer-independent or a constitutively active promoters, operably linked to the gene encoding the protein of interest (page 13 line 13 through page 15 line 17). Stocks discloses that the method has increased production of hyaluronic acid and thereby increased efficiency in the production of hyaluronan synthase (abstract and pages 5-7). Regarding claim 3, Stocks discloses using a signal peptide to secret the polypeptide (page 17, lines 3-25). Regarding claim 4, Stocks discloses that the promoter is an amyQ promoter (page 14, lines 8-14). Regarding claim 4, use of the promoter aprE in expression of a polypeptide of interest in Bacillus was well known in the art, see Rij (page 18, line 23 through page 19, line 6). Regarding claim 14, Stocks discloses a first temperature for the first cultivation and a second temperature for the second cultivation (claim 1 ad pages 21-23). Regarding claim 15, Stocks discloses a temperature difference of 3°C-7°C (claim 27). Regarding claim 16, Stocks discloses that the Bacillus host cell is a Bacillus licheniformis host cell (page 7, lines 25-34). Regarding claim 17, Stocks discloses introduction of an expression construct for the gene encoding the protein of interest by genetic modification (page 8, line 16 through page 9, line 12). Therefore, it would have been obvious to one having ordinary skill in the art to modify the claims of the reference application by using an aprE promoter or amyQ promoter to express the gene encoding the protein of interest by genetic modification in Bacillus subtilis or Bacillus licheniforms and secrete the protein of interest. One having ordinary skill in the art would have been motivated to do so in order to increase expression of the protein of interest. One having ordinary skill in the art would have had a reasonable expectation of success at arriving at the claimed invention because the claims of the reference application discloses a method of producing a polypeptide of interest in a Bacillus host cell under two cultivation steps with different feed rate and temperature and introduction of a protein of interest into Bacillus subtilis/Bacillus licheniformis host cells using aprE or amyQ promoters were known in the art. Therefore, the conflicting claims are not patentably distinct from each other . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 07-37 AIA Applicant's arguments filed April 7, 2026 have been fully considered but they are not persuasive. Applicant requests the withdrawn of the above rejection because Rij and Stocks are unrelated to the subject matter of the primary reference (Sun) as discussed on pages 7-8 of the Remarks filed on April 7, 2026. This is not found persuasive. On pages 7-8 of the Remarks filed on April 7, 2026, Applicant argues that Rij and Stocks are unrelated to the primary reference (Sun). However, the above rejection does not rely on the teachings of Sun. Hence the rejection has been maintained. Conclusion Claims 1-17 and 19-20 are pending. Claim 19 is withdrawn. Claims 1-17 and 20 are rejected. 07-39 AIA THIS ACTION IS MADE FINAL. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm. 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, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /YONG D PAK/Primary Examiner, Art Unit 1652 Application/Control Number: 18/018,094 Page 2 Art Unit: 1652 Application/Control Number: 18/018,094 Page 3 Art Unit: 1652 Application/Control Number: 18/018,094 Page 4 Art Unit: 1652 Application/Control Number: 18/018,094 Page 5 Art Unit: 1652 Application/Control Number: 18/018,094 Page 6 Art Unit: 1652 Application/Control Number: 18/018,094 Page 7 Art Unit: 1652 Application/Control Number: 18/018,094 Page 8 Art Unit: 1652 Application/Control Number: 18/018,094 Page 9 Art Unit: 1652 Application/Control Number: 18/018,094 Page 10 Art Unit: 1652 Application/Control Number: 18/018,094 Page 11 Art Unit: 1652 Application/Control Number: 18/018,094 Page 12 Art Unit: 1652
Prosecution Insights