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 .
The amendment filed 10/16/25 has been entered. Claims 1, 3, 6-9 and 12 have been amended. Claim 21 is new. Claims 1-3, 6-9, 12, 16-17 and 20-21 are pending and are under examination.
Claim Rejections Withdrawn
The rejection of claims 1-3, 12, 16-17 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of the amendment to the claims.
The rejection of claim(s) under 35 U.S.C. 102(a)(1) as being anticipated by Castado et al. WO 2005032584 4/14/2005 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 1 and 3 under 35 U.S.C. 102(a)(1) as being anticipated by Database Uniprot UPI0001E774F5 19 March 2013 cited in IDS is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 5, 6, 7, 12, 18, 19 and 20 under 35 U.S.C. 103 as being unpatentable over Chang et al. WO 2010/010983 1/28/2010 in view of NCBI Reference Sequence: WP_033453403.1 3/15/2017, GenBank: BX640413.1 February 2015 and Castado et al. US 2007/0116711 5/24/2007 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 9 under 35 U.S.C. 103 as being unpatentable over Chang et al. WO 2010/010983 1/28/2010 and NCBI Reference Sequence: WP_033453403.1 3/15/2017 and GenBank: BX640413.1 February 2015 and Castado et al. US 2007/0116711 5/24/2007 as applied to claims 5, 6, 7, 12, 18, 19 and 20 further in view of Locht et al. US 9,839,683 12/12/2017 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 8 under 35 U.S.C. 103 as being unpatentable over Chang et al. WO 2010/010983 1/28/2010 and NCBI Reference Sequence: WP_033453403.1 3/15/2017 and GenBank: BX640413.1 February 2015 and Castado et al. US 2007/0116711 5/24/2007 as applied to claims 5, 6, 7, 12, 18, 19 and 20 further in view of Devos et al. US 2022/0339277 10/27/22 with foreign priority to EP 19200878.7 filed 10/1/2029 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 8 under 35 U.S.C. 103 as being unpatentable over Chang et al. WO 2010/010983 1/28/2010 and NCBI Reference Sequence: WP_033453403.1 3/15/2017 and GenBank: BX640413.1 February 2015 and Castado et al. US 2007/0116711 5/24/2007 as applied to claims 5, 6, 7, 12, 18, 19 and 20 further in view of Van der Lay et al. US 2023/0270849 08/312023 with foreign priority to EP 20173663.4 filed May 8, 2020 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 5, 6, 7, 12, 18, 19 and 20 under 35 U.S.C. 103 as being unpatentable over Grifantini et al. US2016/0067327 March 19, 2017 cited in IDS in view of NCBI Reference Sequence: WP_033453403.1 3/15/2017, GenBank: BX640413.1 February 2015 and Castado et al. US 2007/0116711 5/24/2007 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 8 under 35 U.S.C. 103 as being unpatentable over Grifantini et al. US2016/0067327 March 19, 2017 cited in IDS and NCBI Reference Sequence: WP_033453403.1 3/15/2017 and GenBank: BX640413.1 February 2015 and Castado et al. US 2007/0116711 5/24/2007 as applied to claims 5, 6, 7, 12, 18, 19 and 20 further in view of Van der Lay et al. US 2023/0270849 08/312023 with foreign priority to EP 20173663.4 filed May 8, 2020 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 9 under 35 U.S.C. 103 as being unpatentable over Grifantini et al. US2016/0067327 March 19, 2017 cited in IDS and NCBI Reference Sequence: WP_033453403.1 3/15/2017 and GenBank: BX640413.1 February 2015 and Castado et al. US 2007/0116711 5/24/2007 as applied to claims 5, 6, 7, 12, 18, 19 and 20 further in view of Locht et al. US 9,839,683 12/12/2017 is withdrawn in view of the amendment to the claims.
The rejection of Claim(s) 8 under 35 U.S.C. 103 as being unpatentable over Grifantini et al. US2016/0067327 March 19, 2017 cited in IDS and NCBI Reference Sequence: WP_033453403.1 3/15/2017 and GenBank: BX640413.1 February 2015 and Castado et al. US 2007/0116711 5/24/2007 as applied to claims 5, 6, 7, 12, 18, 19 and 20 further in view of Devos et al. US 2022/0339277 10/27/22 with foreign priority to EP 19200878.7 filed 10/1/2029 is withdrawn in view of the amendment to the claims.
Claim Rejections Maintained
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, 6, 12 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim(s) recite(s):
Claim 1: A polypeptide comprising a sequence having at least 50% sequence identity with SEQ ID NO: 1 and comprising a mutation in an OmpA-like domain, wherein the mutation is located at a position corresponding to any one of positions 120-128 in SEQ ID NO: 1, and wherein the polypeptide comprising the mutation increases OMV production when expressed in Bordetella as compared to OMV production in a Bordetella expressing a polypeptide having SEQ ID NO: 1 and wherein said Bordetella is otherwise identical.
Claim 2: A polypeptide according to claim 1, wherein the mutation is a mutation of a single amino acid residue.
Claim 3: A polypeptide according to claim 1, wherein the mutation is a substitution of an amino acid residue.
This polypeptide encompass a natural variant of OmpA as evidenced by Database Uniprot Accession number A0A1W6ZED7 which discloses the amino acid sequence of a OmpA wild type variant sequence having 86.8% sequence identity with SEQ ID NO: 1 with a substitution T128S in an OmpA-like domain. A0A1W6ZED7 discloses the Bordetella genomosp. 13 that comprises the genomic modification in the amino acid sequence of a OmpA polypeptide having a sequence having 86.8% sequence identity with SEQ ID NO: 1 with a substitution T128S in an OmpA-like domain, wherein the genomic modification results in expression of said OmpA polypeptide.
Bordetella genomosp. 13 is isolated from the sputum of a human. Thus, the bacteria claimed in claim 6, the composition comprising the bacterium in claim 12 and claim 20 are nature based and not markedly different from the natural counterpart found in the sputum of a human. See Bordetella genomosp. 13 AU7206 retrieved from https://img.jgi.doe.gov/cgi-bin/m/main.cgi?section=TaxonDetail&page=taxonDetail&taxon_oid=2765235881 12-20-2017.
See alignment with SEQ ID NO: 1 (comprising a D124N substitution) below:
PNG
media_image1.png
399
667
media_image1.png
Greyscale
This polypeptide encompass a natural variant of OmpA as evidenced by Database Uniprot Accession number A0A1C3K890 which discloses the amino acid sequence of a OmpA wild type variant sequence having 84.2% sequence identity with SEQ ID NO: 1 with a substitution I126T and T1289 in an OmpA-like domain. See alignment with SEQ ID NO: 1 below:
PNG
media_image2.png
450
888
media_image2.png
Greyscale
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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(s) 1-3, 6, 12 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Uniprot Accession number A0A1W6ZED7 July 5, 2017 as evidenced by Bordetella genomosp. 13 AU7206 retrieved from https://img.jgi.doe.gov/cgi-bin/m/main.cgi?section=TaxonDetail&page=taxonDetail&taxon_oid=2765235881 12-20-2017 and as evidenced by Accession number CP021111 REGION: 3571008..3571598 of Bordetella genomosp. 13 strain AU7206 chromosome, complete genome
GenBank: CP021111.1 5-19-2017.
Claims 1-3: Database Uniprot Accession number A0A1W6ZED7 (hereinafter A0A1W6ZED7) discloses the amino acid sequence of a polypeptide having a sequence having 86.8% sequence identity with SEQ ID NO: 1 with a substitution T128S in an OmpA-like domain. See sequence alignment below with a query of SEQ ID NO: 1 with D124N substitution below:
PNG
media_image3.png
417
820
media_image3.png
Greyscale
Claim 6, 12, and 20 : A0A1W6ZED7 discloses the Bordetella genomosp. 13 that comprises the genomic modification in the amino acid sequence of a OmpA polypeptide having a sequence having 86.8% sequence identity with SEQ ID NO: 1 with a substitution T128S in an OmpA-like domain, wherein the genomic modification results in expression of said OmpA polypeptide.
Bordetella genomosp. 13 is isolated from the sputum of a human. Thus, the sputum reads on the composition comprising the bacterium in claim 12 and the pharmaceutical composition of claim 20. Alternatively, there is nothing else listed in the composition of claim 12 and pharmaceutical composition of claim 20, therefore the Bordetella genomosp. 13 reads on these claims.
Bordetella genomosp. 13 comprises the gene comprising a sequence at least 50% sequence identity with SEQ ID NO: 2 that encodes the OmpA polypeptide having a sequence having 86.8% sequence identity with SEQ ID NO: 1 with a substitution T128S in an OmpA-like domain.
PNG
media_image4.png
847
719
media_image4.png
Greyscale
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Uniprot A0A1C3K890 Nov 2, 2016.
Database Uniprot A0A1C3K890 discloses a polypeptide which comprises a sequence having 84.2% sequence identity with SEQ ID NO: 1 with a substitution I126T and T128P in an OmpA-like domain. See sequence alignment below with a query of SEQ ID NO: 1 with D124N substitution. Said polypeptide meets the structural limitations of the claims including the mutations in the OmpA-like domain and thus would necessarily also increase OMV production when expressed in Bordetella as compared to OMV production in a Bordetella expressing a polypeptide having SEQ ID NO: 1 and wherein said Bordetella is otherwise identical.
See sequence alignment below with a query of SEQ ID NO: 1 with D124N substitution.
PNG
media_image2.png
450
888
media_image2.png
Greyscale
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rahmah et al. SG158788-A1 02-26-2010.
Rahmah et al disclose a polypeptide comprising a sequence having at least 50% sequence identity with SEQ ID NO: 1 and comprising a substitution mutation in an OmpA-like domain, wherein the substitution mutations are located at the following position corresponding to SEQ ID NO: 1: S125R, T128S, H122Y, and 120VT. Said polypeptide meets the structural limitations of the claims including the mutations in the OmpA-like domain and thus would necessarily also increase OMV production when expressed in Bordetella as compared to OMV production in a Bordetella expressing a polypeptide having SEQ ID NO: 1 and wherein said Bordetella is otherwise identical.
See sequence alignment below with a query of SEQ ID NO: 1 with D124N substitution.
PNG
media_image5.png
999
618
media_image5.png
Greyscale
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paas et al. WO2011125015 13-10-2011.
Paas et al disclose a polypeptide comprising a sequence having at 90.9% sequence identity with SEQ ID NO: 1 and comprising a substitution mutation in an OmpA-like domain, wherein the substitution mutation is located at the following position corresponding to SEQ ID NO: 1: H122N. Said polypeptide meets the structural limitations of the claims including the mutation in the OmpA-like domain and thus would necessarily also increase OMV production when expressed in Bordetella as compared to OMV production in a Bordetella expressing a polypeptide having SEQ ID NO: 1 and wherein said Bordetella is otherwise identical.
See sequence alignment below with a query of SEQ ID NO: 1 with D124N substitution:
PNG
media_image6.png
1022
499
media_image6.png
Greyscale
Status of Claims
Claims 1-3, 6, 12 and 20 are rejected. Claims 7-9, 16-17 and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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, Gary Nickol can be reached at 5712720835. 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.
/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645