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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-12) in the reply filed on 12/31/2025 is acknowledged. Claims 13-15 are withdrawn from prosecution for being drawn to non-elected subject matter. Claims 1-12 are currently examined.
Claim Rejections - 35 USC § 103
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.
Claims 1-7 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez Martinez et al. (U.S. Pub. No. 20100196412- from here on ‘412 document -cited by Applicant) in view of (Masson et al. - Calcium phosphate: a substitute for aluminum adjuvants? Exp. Rev. Vaccines, 16, 289-299, 2016 -cited by Applicant).
The claims are drawn to a vaccine composition to induce an immune response against the epidermal growth factor (EGF), comprising as active principle a system that contains the recombinant human EGF (rhEGF), or peptides thereof, and a carrier protein, bound to a nucleus formed by inorganic nanoparticles. The nucleus is formed by Calcium base oxides or hydroxides (e.g. hydroxyapatite). The hydroxyapatite may be partially coated with organic ligands. The carrier protein is selected from cholera toxin B subunit, tetanus toxoid, KLH, and P64k of Neisseria meningitidis.
The ‘412 reference teaches a vaccine composition comprising a chemical conjugated between the human recombinant Epidermal Growth Factor (hrEGF) and the P64K recombinant protein (abstract). The vaccine composition also comprise appropriate adjuvants such as Aluminum hydroxide or Montanide ([0015]).
The reference is silent about inorganic adjuvant being in the form of nanoparticle and being a calcium phosphate based one.
Masson et al. discloses that calcium phosphate was one of the substances that could replace alum salts in vaccines before 1980s abstract). Calcium phosphate was initially developed by the Pasteur Institute in hydroxyapatite form (Ca10(PO4)6(OH)2). This adjuvant was used in diphtheria, tetanus, pertussis, and poliomyelitis vaccines it still remains as an approved adjuvant for the World Health Organization (WHO) for human vaccination (p. 289; Table 1). Apart from its excellent storage stability, cold preparation, and relatively inexpensive development, calcium phosphate nanoparticles have positive characteristics. Calcium phosphate nanoparticles exist as rod shaped and sphere shaped. Rod-shaped one can induce both cellular immune response (development of T lymphocytes) by type-1 helper(Th1) way and humoral immune response by Th2 way. Microparticle-sized adjuvants may not be able to induce the same response due to a greater size. Nanoparticle adjuvants also allow the optimization of a selective cell response for the antigen release (p. 294-295). Finally, beyond the comparison with alum salts, calcium phosphate has demonstrated its effectiveness for use in human vaccination (p. 292, Table 4).
it would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have substituted the Aluminum Hydroxide adjuvant of ‘412 reference with the Calcium phosphate nanoparticles of Masson et al. and obtain EGF vaccines with a reasonable expectation of success. This is because a skilled artisan would have used known reagents and methods for a better outcome.
A person of ordinary skill in the art is always motivated to pursue the known options within her or his technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez Martinez et al. (the ‘412 document) in view of (Masson et al. – cited above) and in further view of Zhang et al. (CN 107050447).
The claim adds the limitation that the hydroxyapatite is partially coated by sodium citrate.
The teachings of over Rodriguez Martinez et al. and Masson et al. were presented supra and they were silent about the sodium citrate.
Zhang et al. disclosed a porcine epidemic diarrhea virus inactivated vaccine, containing inactivated porcine epidemic diarrhea virus and an adjuvant, wherein the adjuvant is composed of the following components by weight percentage 5% squalane, 1% oleic acid, 1% Tween 80, 92% 0.005M sodium citrate buffer solution and 1% of beta-glucan, the porcine epidemic diarrhea virus is porcine epidemic diarrhea virus strain (PEDV-KB2013-4 strain) prepared by inactivation ((invention content; Claim 1).
it would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have used known and routinely used vaccine adjuvants for EGF vaccines with a reasonable expectation of success since the knowledge in the art was ubiquitous for vaccine adjuvants. A person of ordinary skill in the art is always motivated to pursue the known options within her or his technical grasp.
Conclusion
No claims are allowed.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647