DETAILED ACTION
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 response filed 12-30-2025 has been entered into the record.
Status of Claims
Claims 28-39 and 48 are pending.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 12-30-2025 is acknowledged. 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)).
Information Disclosure Statement
The information disclosure statements have been considered. Initialed copies are enclosed.
Specification
The title of the invention is not descriptive of the claimed invention. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections - 35 USC § 102
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.
Claims 28, 29, 32, 33, 34, 35 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arumugham et al (US 6,645,503, 2003).
Arumugham et al teach and claim an antigenic conjugate comprising a carrier protein covalently bonded to the conserved portion of an isolated lipopolysaccharide of Neisseria meningitidis wherein the conserved portion of the lipopolysaccharide comprises GlcNAc-Hep2phosphoethanolamine-KDO2-Lipid A, said conjugate eliciting a cross-reactive immune response against heterologous strains of Neisseria meningitidis. The core structure is disclosed as:
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where a KDO is a terminal saccharide unit on a branch.
Arumugham et al also teach the lipopolysaccharide is de-O-acetylated and the carrier proteins include toxins, toxoids, CRM197 a non-toxic derivative of diptheria toxin, exotoxins etc (see claim 2 and 3 of patent). The KDO-KDO sequence represents a two monosaccharide units in a chain where a KDO terminates the chain. Arumugham et al teach various linkers (see claims 4 and 5 of patent). Arumugham et al also teach vaccine formulations (i.e. pharmaceutical formulations; claims 6 and 7 of the patent). Arumugham et al teach that the vaccines formulations contain various adjuvants and physiologically acceptable carriers (column 9, line 26-55). It is noted that the oligosaccharide sequence comprises the sequence and as such a second branch is not excluded by the claim language. As such, the claims are anticipated.
Claims 28, 29, 32, 35 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gustafson et al (US 2011/0027307).
Gustafson et al teach a biologically detoxified LPS of Neisseria sp, specifically Neisseria meningitidis comprising a glucosamine disaccharide backbone of lipid A and its polysaccharide including a non-reducing terminal KDO moiety wherein the lipid A does not comprise ester-linked and amide-linked fatty acids (see claim 28 and 29). Gustafson et al teach that detoxified LPS covalently linked to a carrier protein and may be linked using a hydrazide moiety (see claims 32 and 33). Vaccine formulations contain adjuvants, diluents/excipients and formulated as solutions, emulsions, dispersions, tablets or capsules (see paragraph [0045]). As such, Gustafson et al anticipate the instantly claimed invention.
Claims 28, 29, 32, 35 and 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Apicella et al (WO 2016/007891).
Apicella et al teach chimeric molecules comprising 3-deoxy-d-manno-2-octulosonic acid (KDO) as an immunogen where the KDO is a terminal sugar residue. The KDO of the administered oligosaccharide is attached to galactose via an alpha 2-3 linkage and the galactose is attached to a N-aceytlgalacosamine via a beta1-4 linkage (see abstract and paragraph [0007]). The oligosaccharide may be conjugated to a peptide, polypeptide or protein (paragraph [0010]). The oligosaccharide with carrier may be formulated as a vaccine (paragraph [0012]). Vaccines may comprise addition components for inducing innate or adaptive immunity and can comprise and adjuvant (see paragraphs [0013] and [0041-0043]). Vaccines may be co-administered with other therapeutic or prophylactic agents including antibiotics such a ceftriaxone, ceftazidime, cefotaxime, ampicillin-sulbactam, fluoroquinolones and azithromycin (see paragraph [0045]). All these antibiotics are also well established for use in the treatment of Neisseria sp infections. Apicella et al teach the administration with a second immunogen for vaccination. The structure of the prior art does not distinguish from the structure as disclosed and as such anticipates the instantly claimed invention.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Arumugham et al (US 6,645,503, 2003) as applied to claims 28, 29, 32, 33, 34, 35 and 36 above in view of O’Hagan et al (RE45,137 E, 2014) .
Arumugham et al teach and claim an antigenic conjugate comprising a carrier protein covalently bonded to the conserved portion of an isolated lipopolysaccharide of Neisseria meningitidis wherein the conserved portion of the lipopolysaccharide comprises GlcNAc-Hep2phosphoethanolamine-KDO2-Lipid A, said conjugate eliciting a cross-reactive immune response against heterologous strains of Neisseria meningitidis. The core structure is disclosed as:
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200
208
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where a KDO is a terminal saccharide unit on a branch. Arumugham et al also teach the lipopolysaccharide is de-O-acetylated and the carrier proteins include toxins, toxoids, CRM197 a non-toxic derivative of diptheria toxin, exotoxins etc (see claim 2 and 3 of patent). The KDO-KDO sequence represents a two monosaccharide units in a chain where a KDO terminates the chain. Arumugham et al teach various linkers (see claims 4 and 5 of patent). Arumugham et al also teach vaccine formulations (i.e. pharmaceutical formulations; claims 6 and 7 of the patent). Arumugham et al teach that the vaccines formulations contain various adjuvants and physiologically acceptable carriers (column 9, line 26-55). It is noted that the oligosaccharide sequence comprises the sequence and as such a second branch is not excluded by the claim language. Arumugham et al differ by not teaching combination with other Neisseria immunogens or antimicrobial agents. The specification defines antimicrobial agents at paragraph [0037] to broadly encompass any agent with antimicrobial activity including nucleic acids, antibodies etc.
O’Hagan et al teaches adjuvanted Neisseria sp compositions having N. meningitidis antigens where the composition can further comprise one or more saccharide antigens from N. meningitidis or Haemophilus influenzae B (see claims 33-37) and other meningococcal antigens (see column 9, line 45 – column 10, line 42). These compositions are broadly antimicrobial as the compositions provide for antimicrobial activity.
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to combine the N. meningitidis immunogenic compositions of Arumugham et al and O’Hagan et al because O’Hagan teach that their immunogenic compositions can be combined with saccharide antigens from N. meningitidis. Moreover, the courts have held in In re Kirkhoven (205 USPQ 1069, CCPA 1980) that “It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for the same purpose in order to form third composition that is to be used for the very same purpose:idea of combining them flows logically from their having been individually taught in the prior art.”
Claim 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Gustafson et al (US 2011/0027307) as applied to claims 28, 29, 32, 35 and 36 above in view of O’Hagan et al (RE45,137 E, 2014).
Gustafson et al teach a biologically detoxified LPS of Neisseria sp, specifically Neisseria meningitidis comprising a glucosamine disaccharide backbone of lipid A and its polysaccharide including a non-reducing terminal KDO moiety wherein the lipid A does not comprise ester-linked and amide-linked fatty acids (see claim 28 and 29). Gustafson et al teach that detoxified LPS covalently linked to a carrier protein and may be linked using a hydrazide moiety (see claims 32 and 33). Vaccine formulations contain adjuvants, diluents/excipients and formulated as solutions, emulsions, dispersions, tablets or capsules (see paragraph [0045]). As such, Gustafson et al differ by not teaching combination with other Neisseria immunogens. The specification defines antimicrobial agents at paragraph [0037] to broadly encompass any agent with antimicrobial activity including nucleic acids, antibodies etc.
O’Hagan et al teaches adjuvanted Neisseria sp. compositions having N. meningitidis antigens where the composition can further comprise one or more saccharide antigens from N. meningitidis or Haemophilus influenzae B (see claims 33-37) and other meningococcal antigens (see column 9, line 45 – column 10, line 42). These compositions are broadly antimicrobial as the compositions provide for antimicrobial activity.
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to combine the N. meningitidis immunogenic compositions of Gustafson et al and O’Hagan et al because O’Hagan teach that their immunogenic compositions can be combined with saccharide antigens from N. meningitidis. Moreover, the courts have held in In re Kirkhoven (205 USPQ 1069, CCPA 1980) that “It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for the same purpose in order to form third composition that is to be used for the very same purpose:idea of combining them flows logically from their having been individually taught in the prior art.”
Claim 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Apicella et al (WO 2016/007891) as applied to claims 28, 29, 32, 35 and 36-38 above in view of O’Hagan et al (RE45,137 E, 2014).
Apicella et al teach chimeric molecules comprising 3-deoxy-d-manno-2-octulosonic acid (KDO) as an immunogen where the KDO is a terminal sugar residue. The KDO of the administered oligosaccharide is attached to galactose via an alpha 2-3 linkage and the galactose is attached to a N-aceytlgalacosamine via a beta1-4 linkage (see abstract and paragraph [0007]). The oligosaccharide may be conjugated to a peptide, polypeptide or protein (paragraph [0010]). The oligosaccharide with carrier may be formulated as a vaccine (paragraph [0012]). Vaccines may comprise addition components for inducing innate or adaptive immunity and can comprise and adjuvant (see paragraphs [0013] and [0041-0043]). Vaccines may be co-administered with other therapeutic or prophylactic agents including antibiotics such a ceftriaxone, ceftazidime, cefotaxime, ampicillin-sulbactam, fluoroquinolones and azithromycin (see paragraph [0045]). All these antibiotics are also well established for use in the treatment of Neisseria sp infections. Apicella et al teach the administration with a second immunogen for vaccination. The structure of the prior art does not distinguish from the structure as disclosed and as such anticipates the instantly claimed invention. Apicella et al differ by not teaching combination with Neisseria immunogens. The specification defines antimicrobial agents at paragraph [0037] to broadly encompass any agent with antimicrobial activity including nucleic acids, antibodies etc.
O’Hagan et al teaches adjuvanted Neisseria sp. immunogenic compositions having N. meningitidis antigens with adjuvants/carriers/excipients where the composition can further comprise one or more saccharide antigens Haemophilus influenzae B (see claims 33-37) and other saccharide antigens (see column 9, line 45 – column 10, line 42). These compositions are broadly antimicrobial as the compositions provide for antimicrobial activity as broadly defined in the specification.
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to combine the N. meningitidis immunogenic compositions of O’Hagan et al with the H. influenzae saccharide compositions of Apicella et al because O’Hagan teach that their immunogenic compositions can be combined with further antigen components such as saccharide antigens from H. influenzae. As such, the combination is prima facie obvious.
Claim 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Apicella et al (WO 2016/007891) as applied to claims 28, 29, 32, 35 and 36-38 above in view of Arumugham et al (US 6,645,503, 2003).
The teachings of Apicaella et al are set forth above. Apicella et al differs by not teaching the carriers of claims 33 and 34.
Arumugham et al (US 6,645,503, 2003) teach useful carrier proteins for saccharide conjugation include toxins, toxoids, CRM197 a non-toxic derivative of diphtheria toxin, exotoxins etc (see claim 2 and 3 of patent).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute any one of the protein carriers as taught by Arumugham et al for the protein in the conjugate of Apicella et al as Arumugham et al teach that the proteins are suitable carriers for immunogenic saccharide conjugates. The selection of a different known protein carrier is prima facie obvious as they perform the same function.
Free of Prior Art
Claims 30, 31 and 48 are objected to as being dependent upon a rejected base claim 28, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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