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 11/3/25 has been entered. Claims 16-36 are pending and are under examination.
Claim Rejections Withdrawn
The rejection of claim 16-24 and 32-36 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 17619334 (‘334) is withdrawn in view of the filing of express abandonment of the ‘334 application.
The rejection of claims 25-31 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 17619334 (‘334) as applied to claims 16-24 and 32-36 above, further in view of Feldman et al. WO 2019/241672 12/19/2019 is withdrawn in view of the filing of express abandonment of the ‘334 application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 16, 17, 19-34 and 36 is/are rejected under 35 U.S.C. 103 as being obvious over Braun et al. US 2023/0346902 11/2/2023 with priority to provisional application 63/040,844 is maintained.
Braun et al (‘844 application herein after) disclose a modified exotoxin A protein of P. aeruginosa EPA comprising an amino acid sequence at least 80% identical to SEQ ID NO: 1 (see SEQ ID NO: 1 and SEQ ID NO: 2 of Braun et al) and further comprising a glycosylation sequence D/E-X-N-Z-S/T or K-D/E-X-N-Z-S/T-K or J-D/E-X-N-Z-S/T-U which corresponds to the disclosed K-D/E-X-N-Z-S/T-K (wherein X and Z can be any amino acid except proline) wherein X and Z can be any amino acid except proline. See p. 40 lines 1-21, p. 43 lines 1-27 and p. 63 lines 1-20.
Braun et al disclose that a glycosylation sequence a “sequon” of D/E-X-N-Z-S/T, wherein the sequon is a variant of D/E-X-N-Z-S/T can be substituted for the residue at 274 or at residue 519. See p. 65 lines 10-15, and p. 615 line 44. These residues are at an equivalent position within the amino acid sequence of Braun et al which is at least 80% identical to SEQ ID NO: 1.
Braun et al disclose that the protein carrier can comprise one, two or three glycosylation sites. See p. 40 lines 22-24.
Claim 23: The modified EPA was detoxified with a substitution of Leu552 to valine and Glu553 was deleted. See p. 38 lines 5-13.
Claim 24-25: Braun et al disclose a conjugate comprising Shigella polysaccharide antigen and the modified EPA protein being covalently linked to the antigen. See p. 1 lines 6-10, p. 4 under summary of the invention, p. 17 lines 22-23, p. 27.
Claim 26-27: Braun et al disclose a method of making a recombinant N-glycosylated modified EPA in a host cell such as Escherichia, Salmonella, Shigella, Helicobacter, Pseudomonas or Bacillus wherein the host cell comprises one or more first nucleotide sequences integrated into the host genome and comprise polysaccharide genes (i.e. the polysaccharide rfb cluster is replaced by an O-polysaccharide cluster) and a second nucleotide sequence e.g. a plasmid encoding a heterologous oligosaccharyltransferase from Campylobacter and a third nucleotide sequence e.g. a plasmid encoding the modified EPA. Braun et al disclose culturing the host cells in order to produce the bioconjugate/glycoprotein and harvesting the glycoprotein from the periplasm. See p. 1 under field of invention, p. 5 lines 30 -35, p. 6 lines 26-30, p. 30 lines 9-19, p. 31 lines 7-11, p. 36 lines 3-20, p. 41 lines 22-41, p. 42 lines 1-33, p. 43 lines 25-37, p. 44-46
Claim 28-29: Braun et al disclose an immunogenic composition comprising the conjugate and pharmaceutically acceptable excipient or carrier and also an adjuvant. See p.26 lines 26-37 to p.32.
Claim 30-31: Braun et al disclose a inducing an immune response in a subject comprising administering an immunologically effective amount of the composition to the subject. See p. 11 lines 21-37 and p. 30 lines 25-31.
Claim 32-33: Braun et al disclose the amino acid sequence of EPA is 93.9% identical to equivalent to SEQ ID NO:1 or 98.7% without the signal peptide.
See p. 63 SEQ IS NO: 1 or 2.
Alignment of SEQ ID NO: 2 at p. 63 with SEQ ID NO: 1:
PNG
media_image1.png
895
709
media_image1.png
Greyscale
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified Braun et al by adding the glycosylation sequence D/E-X-N-Z-S/T or K-D/E-X-N-Z-S/T-K (wherein X and Z can be any amino acid except proline) or J-D/E-X-N-Z-S/T-U which corresponds to the disclosed K-D/E-X-N-Z-S/T-K (wherein X and Z can be any amino acid except proline) in lieu of residues R274 or A519 or both, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Braun et al disclose that said glycosylation consensus sequence can be substituted at residue R274 or at residue A519 and that the carrier protein can comprise two glycosylation consensus sequence.
Response to Applicant’s Reply
The statement under 35 USC 102(b)(2)(c) has been considered but is found defective. The statement does not state that not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The statement filed by applicant that U.S. Application No. 18/001,551 and U.S. Application No. 18/001,498 were commonly owned by or subject to an obligation to assign to Glaxosmithkline Biologicals SA at the time U.S. Application No. 18/001,498 was effectively filed does not make clear that not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
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 26-27 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.
Claims 26 and 27 recite:
“one or more first nucleotide sequences, which are integrated into the host cell genome and comprise: polysaccharide synthesis genes that encode a bacterial polysaccharide antigen, polysaccharide synthesis genes that encode a yeast polysaccharide antigen, or polysaccharide synthesis genes that encode a mammalian polysaccharide antigen”.
Since a gene encodes a protein, it is impossible for the polysaccharide synthesis genes to encode a bacterial polysaccharide, a yeast polysaccharide antigen and a mammalian polysaccharide.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 34 and 35 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 34 fails to further limit the scope of claim 17. Claim 34 recites “the first of the one or more of the glycosylation consensus sequence”. However in claim 17 the modified EPA comprises “two or more of the glycosylation consensus sequence”.
Claim 35 fails to further limit the scope of claim 18. Claim 35 recites “the first of the one or more of the glycosylation consensus sequence”. However in claim 18 the modified EPA comprises “three or more of the glycosylation consensus sequence”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Status of Claims
Claims 16-17 and 19-36 are rejected. Claim 18 is 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.
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, Daniel Kolker can be reached at 5712723181. 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