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 1/6/26 has been entered. Claims 2-7, 9-16 and 29-30 have been cancelled. Claim 1, 22-28, and 31-36 is amended. Claims 1, 8, 17-28 and 31-36 are pending and are under examination.
Claim Rejections Withdrawn
The rejection of claim(s) 1, 8, 17-21, 22-28 and 31-36 under 35 U.S.C. 102(a)(1) as being anticipated by Levine et al. US 2013/0129776 5/23/2013 cited in IDS/cited previously is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 1, 8, 17-28, 31, and 33 under 35 U.S.C. 102(a)(1) as being anticipated by Baliban et al Molecules 2018, 23(7), 1749 published 7-17-2018 cited in IDS and cited previously is withdrawn in view of the amendments to the claims.
The rejection of claim(s) 1, 8, 17-21, 22-28 and 31-36 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Levine et al. US 2013/0129776 5/23/2013 is withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 102 and 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.
Claim(s) 1, 8, 17-20, 24-27, 32, 34 and 35 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tennant et al. WO 2016168324 10-20-2016.
Tennant et al disclose:
Longer chain antigenic O-polysaccharide chains for use as a hapten in conjugate vaccines can be produced in a controlled manner using recombinant Gram-negative bacteria that overexpress native or heterologous genes of the wzz family, for example wzzB.
Tennant et al disclose that bacteria expressing a chosen wzz gene have modified O-polysaccharide chain lengths, allowing the bacteria to produce lipopolysaccharides having the longer O-polysaccharides and that the LPS produced by the bacteria can be hydrolyzed to form core-O-polysaccharide molecules that can be conjugated to a carrier molecule, for example flagellin, to produce a vaccine.
See abstract.
Tennant et al disclose that more preferably, the Gram-negative bacterial strain is selected from the group consisting of Salmonella enterica serotype Enteritidis CVD 1943, Salmonella enterica serotype Typhimurium CVD 1925, Salmonella enterica serotype Paratyphi A CVD 1902, and Shigella flexneri CVD 1208S. See paragraph 8.
Tennant et al disclose a core O polysaccharide purified from wzz family protein overexpressing Gram-negative bacteria, preferably Salmonella enterica serotype Typhimurium CVD 1925 or Salmonella enterica serotype Paratyphi A CVD 1902. See paragraph 11.
Tennant et al disclose embodiments such as a conjugate or complexed vaccine comprising one or more of these core O polysaccharide haptens, wherein the core O polysaccharide hapten is covalently linked or complexed to a carrier protein. See paragraph 12.
Claim 1, 32, 34, 35: The disclosure of vaccine comprising one or more of these core O polysaccharide haptens, wherein the core O polysaccharide hapten is covalently linked or complexed to a carrier protein by Tennant et al anticipates the claimed
bivalent compositions comprising the Salmonella Typhimurium core O polysaccharide conjugate and Salmonella paratyphi core O polysaccharide conjugate;
bivalent composition comprising Salmonella enteritidis core O polysaccharide conjugate and Salmonella paratyphi core O polysaccharide conjugate; and
trivalent composition comprising the Salmonella Typhimurium core O polysaccharide conjugate, Salmonella paratyphi core O polysaccharide conjugate and Salmonella enteritidis core O polysaccharide.
In the alternative, the disclosure of vaccine comprising one or more of these core O polysaccharide haptens, wherein the core O polysaccharide hapten is covalently linked or complexed to a carrier protein by Tennant et al would have rendered the claimed bivalent or trivalent composition (as stated 1-3 above) prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention, resulting in the instant invention with a reasonable expectation of success.
The teaching or suggestion for said one of ordinary skill in the art as of the effective filing date to have made the instant bivalent and trivalent compositions is that L Tennant et al disclose a core O polysaccharide purified from wzz family protein overexpressing Gram-negative bacteria, preferably Salmonella enterica serotype Typhimurium CVD 1925 or Salmonella enterica serotype Paratyphi A CVD 1902. See paragraph 11.
Tennant et al disclose embodiments such as a conjugate or complexed vaccine comprising one or more of these core O polysaccharide haptens, wherein the core O polysaccharide hapten is covalently linked or complexed to a carrier protein. See paragraph 12.
In addition, Tennant et al disclose that more preferably, the Gram-negative bacterial strain is selected from the group consisting of Salmonella enterica serotype Enteritidis CVD 1943, Salmonella enterica serotype Typhimurium CVD 1925, Salmonella enterica serotype Paratyphi A CVD 1902, and Shigella flexneri CVD 1208S. See paragraph 8.
Thus, a selection of any two or any three Salmonella antigen conjugates would have encompassed the claimed bivalent or trivalent antigen compositions (1-3 above)..
Claim 8: Tennant et al disclose the dosage of each conjugate at about 10 µg-a bout 1000 µg per dose. See paragraph 96. W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)). Prior art which teaches a range overlapping or touching the claimed range anticipates if the prior art ranged discloses the claimed range with “sufficient specificity”. See MPEP 2131.03 (I)(II). Levine et al disclose different doses within the claimed range such as about 10 µg to about 1000 µg per dose. The claimed range of about 5 ug/dose to about 30 ug per dose overlaps with the range disclosed by Tennant et al.
Claim 17. Tennant et al disclose a method of preventing or treating a Salmonella infection comprising administering an effective amount of the immunogenic composition a to a patient. See paragraph 15 and 90-98.
Claim 18. Tennant et al disclose wherein administering comprises administration by injection. See paragraph 133.
Claim 19. Tennant et al disclose the composition being administered is the same as claimed in claim 1, thus the administration to the patient as disclosed by Tennant et al necessarily results in an eight-fold rise in antibody titer.
Claim 20. Tennant et al disclose a method for the manufacture of the immunogenic composition as claimed in claim 1, comprising:
a. providing the antigenic components;
b. conjugating each of the antigens to a carrier molecule; and
c. preparing each conjugate at the dose as stated above.
See paragraphs 68-71, 73-76 and 96
Tennant et al disclose that conjugating is performed by methods known in the art. See paragraphs 73-76.
CDAP chemistry See paragraph 160.
Claim 24-27: Tennant et al disclose the carrier molecules are Flagellin A, flagellin B, tetanus toxin/toxoid, diphtheria toxin/toxoid, CRM197, Phase 1 flagella protein, Phase 2 flagella protein, Cholera toxin/toxoid, recombinant exoprotein A rEPA, B. pertussis FHA fragments, Haemophilus influenzae protein D, outer membrane proteins of Neisseria meningitidis, and outer membrane proteins of Neisseria gonorrhoeae, FliC. See paragraph 73 and 91.
Claim(s) 1, 21,22-23 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tennant et al. WO 2016168324 10-20-2016 in view of Levine et al. US 2013/0129776 5/23/2013 cited in IDS.
Levine et al disclose conjugates of core O polysaccharide (COPS) of Salmonella to carrier proteins wherein the COPS are S. typhimurium, S. enteritidis and S. paratyphi. See paragraph 10, paragraphs 66-67, 77, 81, 85).
Levine et al disclose each antigen of the two or more antigen is conjugated to one or more carrier molecules; and wherein one antigen of the two or more antigens is conjugated to two or more carrier molecules i.e. a lattice that can be formed by inter-molecular linkage by a single COPS molecule with multiple protein subunits (paragraph 294)… in some embodiments, an activated hapten molecule can react with and form more than one linkage to more than one carrier protein molecule, wherein the linkage is 2 or more (see paragraph 167).
Levine et al disclose conjugation is by CDAP chemistry.
Levine et al disclose that the two or more carrier molecules consist of 2 or more than two carrier molecules i.e. a lattice that can be formed by inter-molecular linkage by a single COPS molecule with multiple protein subunits (paragraph 294)… in some embodiments, an activated hapten molecule can react with and form more than one linkage to more than one carrier protein molecule, wherein the linkage is 2 or more (see paragraph 167).
Levine et al disclose that hydroxyl group can be added to the COPS which is then cross-linked to hydrazide on the carrier (see paragraph 152).
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 Tennant et al by conjugating the COPS to the carrier protein using methods known in art such as CDAP chemistry, using two carrier molecules or more than two carrier molecules such that an activated hapten (COPS) molecule can react with and form more than one linkage to more than one carrier protein molecule, wherein the linkage is 2 or more and such that that hydroxyl group can be added to the COPS which is then cross-linked to hydrazide on the carrier as taught by Levine et al, resulting in the instant rejection with a reasonable expectation of success.
The motivation to do so is that Tennant et al discloses the conjugation can be carried out by known techniques and Levine et al disclose conjugation techniques for conjugating COPS to carrier protein which were known techniques in the art.
Allowable Subject Matter
Claims 31, 33 and 36 are objected to as being dependent upon a rejected base claim. The allowable subject matter is drawn to the bivalent and trivalent compositions which comprise S. typhi which are as set forth in claims 31, 33 and 36.
Status of Claims
Claims 1, 8, 17-28, 32 and 34-35. Claims 31, 33 and 36 are objected to.
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.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645