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 with traverse of Group I, claims 1-10 and 18-21, in the reply filed on December 31, 2025 is acknowledged. The traversal is on the grounds that: (1) the European Patent Office did not find unity of invention lacking in the international proceedings, and (2) the claims are directed to a product and a process specially adapted for the manufacture of that product and therefore they are expressly permitted by 37 CFR 1.475(b)(1). These arguments are not found persuasive. As for ground (1), as applicant points out, the international proceedings are not binding on the proceedings of the U.S. national stage. Therefore, the USPTO is free to make its own determination on whether or not unity of invention exists and this argument is unpersuasive. As for ground (2), applicant argues that even if a lack of unity of invention is justified under PCT Rule 13.2, it should not be made if the claims fall within the “safe harbor” of 37 CFR 1.475(b)(1). However, applicant’s position on this issue is incorrect. The regulation itself establishes that 1.475(b) operates within the constraints of 1.475(a), which defines that unity of invention only exists when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features, where special technical features are expressly defined as features that define a contribution which each of the claimed invention, considered as a whole, makes over the prior art. An application that satisfies category (b) is not automatically granted unity – it is presumed to satisfy (a), subject to rebuttal by evidence showing the actual technical relationship fails. In this case, the technical feature shared among the claims has been shown by evidence to be known in the prior art. Therefore, it is not a special technical feature and unity of invention does not exist – even though the claims are directed to a product and a process for its manufacture. The arguments presented are unpersuasive and unity of invention is not present.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 31, 2025.
Claim Objections
Claims 9 and 20 are objected to because of the following informalities:
Regarding claim 9, in line 10, there should be a space between contents and a).
Regarding claim 20, in line 6, there should be a space between contents and a).
Appropriate correction is required.
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 3, 4, 18, and 21 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.
Regarding claim 3, claim 3 recites the limitation "the monomer unit" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of further examination, this limitation will be interpreted as “the at least one hydrophilic monomer unit” of claim 2.
Regarding claim 18, claim 18 recites the limitation "The vaccine" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of further examination, this limitation will be interpreted as “The vaccine adjuvant,” to which claim 5 is directed.
Regarding claims 4 and 21, these claims depend from a rejected claim and include all of the limitations thereof. Therefore, they are also rejected.
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 1-4, 6-8, 10, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dupuis et al. (US 2010/0233196).
Regarding claim 1, Dupuis et al. teaches an adjuvant composition for vaccines comprising an aqueous solution containing a dispersed inverse latex (¶33, 34). The inverse latex is a water-in-oil emulsion polymer (¶36). The polymer can be poly(sodium acrylate) (a polyelectrolyte-type polymer) (¶67) in the form of drops of microgels having an average size of between 0.5 and 5 micrometers (¶32) making the inverse latex an inverse microemulsion.
Regarding claims 2-4 and 6, Dupuis et al. teaches that the vaccine adjuvant composition of step a), which is the inverse microemulsion/microlatex as claimed, comprises an oily phase (¶48), an aqueous phase (¶34), at least one water-in-oil (W/O) surfactant (¶63), at least one oil-in-water (O/W) surfactant (¶65), and an anionic and crosslinked polyelectrolyte polymer (¶59) comprising at least one crosslinking monomer (¶62) and at least one hydrophilic monomer unit such as acrylic acid that is completely or partially salified with a sodium salt or an ammonium salt (poly(sodium acrylate)) (¶59, 67).
Regarding claims 7 and 19, Dupuis et al. teaches that the adjuvant composition comprises from 1 to 5% by mass the water-in-oil surfactant (¶63).
Regarding claim 8, Dupuis et al. teaches that the adjuvant composition comprises from 2 to 8% by weight of an oil-in-water surfactant (¶65).
Regarding claim 10, Dupuis et al. teaches that the oil used (Marcol 52) is a white mineral oil (¶50, 94).
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.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dupuis et al. (US 2010/0233196) as applied to claims 1 and 2 above.
Regarding claim 5, Dupuis et al. teaches the composition of claims 1 and 2 as set forth above. Dupuis et al. additionally teaches that the crosslinked anionic polyelectrolyte polymer may be a copolymer of acrylic acid and of alkyl acrylates of which the carbon chain contains between ten and thirty carbon atoms (¶59). The alkyl acrylates correspond to monomers of formula (1) where R1 is hydrogen, n is 0, and m is between 10 and 30. At the time of the filing of the instant invention, a person of ordinary skill in the art would have found it obvious to use a crosslinked anionic polyelectrolyte polymer containing an alkyl acrylate monomer, and would have been motivated to do so because Dupuis et al. teaches that these monomers are suitable for use in the disclosed polyelectrolyte polymers.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Dupuis et al. (US 2010/0233196) as applied to claims 1 and 6 above.
Regarding claim 9, Dupuis et al. teaches the adjuvant composition of claims 1 and 6 as set forth above. Dupuis et al. teaches that the oily phase is used in an amount of from 10 to 50% by mass (¶58). While there is overlap of the disclosed range and claimed range of the oily phase at 50% by mass, this overlap does not teach that the claimed amount of oily phase with sufficient specificity for an anticipation rejection. However, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05. At the time of the filing of the instant invention, a person of ordinary skill in the art would have found it obvious to form an adjuvant composition comprising 50% by mass of the oily phase, as taught by Dupuis et al., and would have found it obvious to do so because Dupuis et al. teaches that this amount is suitable for use in the disclosed invention.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Dupuis et al. (US 2010/0233196) as applied to claims 1-3 above.
Regarding claim 21, Dupuis et al. teaches the composition of claims 1-3 as set forth above. Dupuis et al. additionally teaches that the crosslinked anionic polyelectrolyte polymer may be a copolymer of acrylic acid and of alkyl acrylates of which the carbon chain contains between ten and thirty carbon atoms (¶59). The alkyl acrylates correspond to monomers of formula (1) where R1 is hydrogen, n is 0, and m is between 10 and 30. At the time of the filing of the instant invention, a person of ordinary skill in the art would have found it obvious to use a crosslinked anionic polyelectrolyte polymer containing an alkyl acrylate monomer, and would have been motivated to do so because Dupuis et al. teaches that these monomers are suitable for use in the disclosed polyelectrolyte polymers.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dupuis et al. (US 2010/0233196) as applied to claims 1, 2, and 5 above, and further in view of Braun et al. (US 2008/0312343).
Regarding claim 18, Dupuis et al. teachers the composition of claims 1, 2, and 5 as set forth above. While Dupuis et al. teaches using alkyl acrylate monomers in the disclosed polyelectrolyte polymers, Dupuis et al. does not teach using alkyl methacrylate monomers, i.e., where R1 is a methyl group instead of a hydrogen group. However, Braun et al. teaches an inverse latex of a crosslinked anionic acrylic-acid polyelectrolyte polymer containing a comonomer of formula (I”):
CH2=C(CH3)—C(=O)-O-(CH2—CH2—O)n”—R”4
wherein R”4 represents an aliphatic radical chosen from octyl, dodecyl, tetradecyl, hexadecyl, octadecyl, eicosyl, docosyl and tetracosyl radicals, and n” represents a number between 4 and 25 (¶6, 7, 19, 28, 30). The comonomer of formula (I”) corresponds to the monomer of claimed formula (1) wherein R1 is -CH3, n is between 4 and 25, and m is between 8 and 24. Dupuis et al. and Braun et al. are analogous art because they are from the same field of endeavor as that of the instant invention, namely that of inverse latex emulsions comprising a polyelectrolyte polymer, an oil phase, and emulsifiers for use in the pharmaceutical industry. At the time of the filing of the instant invention, a person of ordinary skill in the art would have found it obvious to use a comonomer, as taught by Braun et al., in the polymer for use in the composition, as taught by Dupuis et al., and would have been motivated to do so because Braun et al. teaches that ethoxylated acrylates and methacrylates (formulae I’ and I”) are art recognized equivalents used for the same purpose in crosslinked polyelectrolyte polymers containing acrylic acid used for pharmaceutical purposes and one of ordinary skill in the art would have a reasonable expectation of success in substituting one for the other. MPEP 2144.06 II.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Glass et al. (US 3,919,411) in view of Dupuis et al. (US 2010/0233196).
Regarding claim 20, Glass et al. teaches a vaccine adjuvant (Col. 1, lines 16-25) comprising a polyelectrolytic acrylic acid polymer dispersed in an emulsion system of oil, water, and surfactant (Col. 3, line 66 to Col. 4, line 3). The polymer is “Carbopol 934P,” which is a polymer of acrylic acid crosslinked with polyallyl sucrose (Col. 5, lines 15-18), combined with an emulsifier containing either a nonionic or amphoteric, nontoxic surfactant or mixtures thereof in a water-in-oil or oils-in-water emulsion carrier (Col. 5, lines 18-21). Glass et al. teaches that the oil content is at least about 25 to 85% by volume (Col. 5, lines 59-62) and the surfactant content is from about 1 to 20% by volume (Col. 6, lines 2-5). Glass et al. expressly teaches combining a low-HLB (water-in-oil) surfactant with a high-HLB (oil-in-water) surfactant in one and the same composition (Col. 5, lines 44-52). Specifically, Example IV, Entry No. 3 (Col. 12, lines 9-11) pairs a high-HLB (O/W) surfactant, Tween 80, with a low-HLB (W/O) surfactant, Arlacel 80, each in an amount of 5% by volume. Additionally, the recitation in volume percent rather than weight percent is not a patentable distinction, as the densities of each component are near unity and conversion is a matter of routine skill.
Glass et al. does not teach that the polyelectrolyte polymer is an inverse microlatex present in from 1 to 10% by weight. However, Dupuis et al. teaches an adjuvant composition comprising a polyelectrolyte polymer as an inverse latex (¶1, 36), wherein the polymer is a crosslinked anionic polyelectrolyte polymer comprising acrylic acid (¶59) and present in from 0.5 to 30% by mass (¶68). Additionally, Dupuis et al. teaches that the polymer used is in the form of microgels having a size of from 50 nm to 100 microns (teaches microlatex) (¶25-30). Glass et al. and Dupuis et al. are analogous art because they are from the same field of endeavor as that of the instant invention, namely that of vaccine adjuvant compositions. At the time of the filing of the instant invention, a person of ordinary skill in the art would have found it obvious to substitute the inverse microlatex, as taught by Dupuis et al., for the polymer in the composition, as taught by Glass et al., and would have been motivated to do so because Dupuis et al. teaches that a comparison of the adjuvant properties of dispersions of inverse latexes relative to polymers having the same chemical composition but obtained by solvent-phase synthesis followed by precipitation, demonstrates much greater adjuvant effects both on the humoral response (diagram 1) and on the cellular response, accompanied by a high degree of innocuousness (diagram 2) (¶92).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA C SCOTT whose telephone number is (571)270-3303. The examiner can normally be reached Monday-Friday, 8:30-5:00, EST.
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/ANGELA C SCOTT/Primary Examiner, Art Unit 1767
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