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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-27 in the reply filed on 9 February 2026 is acknowledged.
Claims 28-30 and 35 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 February 2026.
Claim Interpretation
Claim 19 recites that aluminum phosphate has the abbreviation “ALPO” and aluminum hydroxide has the abbreviation “ALOH.” The examiner clarifies that these abbreviations are interpreted as not limiting the molar ratio of aluminum to phosphate or hydroxide and are not interpreted as chemical formulas. The examiner clarifies that aluminum hydroxide has the chemical formula Al(OH)3 because aluminum ions are trivalent and positively charged and hydroxide ions are monovalent and negatively charged; as such, three hydroxide ions are needed to balance the charge of one aluminum ion. Regarding phosphate, the examiner notes that both aluminum and phosphate are trivalent; as such, only one phosphate anion is needed to balance the charge of one aluminum cation. However, phosphate is a polyatomic anion having a formula of PO33-; as such, aluminum phosphate has the chemical formula of AlPO3. As such, the examiner interprets the abbreviations of ALPO and ALOH as not limiting the ratio of phosphorus to oxygen in the phosphate ion in aluminum phosphate and not limiting the ratio of hydroxide to aluminum in aluminum hydroxide. As such, the claims that recite these formulas are not rejected as indefinite.
Claim Rejections - 35 USC § 103 – Obviousness
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 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.
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(s) 1-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fairman et al. (US 2020/0054739 A1).
Fairman et al. (hereafter referred to as Fairman) is drawn to a conjugated vaccine, as of Fairman, title and abstract.
As to part (a) of claim 1, Fairman teaches protein-antigen conjugates wherein the antigens are polysaccharides, which would have resulted in a protein-polysaccharide conjugate, as of Fairman, paragraph 0014. Fairman teaches non-natural amino acids in the abstract, and teaches at least two non-natural amino acids in paragraph 0008.
As to part (b) of claim 1, Fairman teaches an aluminum adjuvant as of at least paragraphs 0517-0518.
As to part (c) of claim 1, Fairman teaches phosphate buffer in paragraph 0313 and 0325; this appears to refer to a non-aluminum phosphate salt. Fairman teaches disodium phosphate dehydrate in paragraph 0530 and sodium phosphate in paragraph 0531.
As to part (d) of claim 1, Fairman teaches 0.9% sodium chloride in paragraph 1276.
As to claim 1, the claim requires less than 200 mM of sodium chloride. Fairman teaches 0.9% sodium chloride in paragraph 1276. As best understood by the examiner, this is 0.154 M or 154 mM sodium chloride, which is less than 200 mM sodium chloride.
As to claim 1, the claim requires a pH of between about 5.5 and 7. Fairman teaches multiple pH values in the table on page 123 of Fairman; these include pH values of 6.7, as of the first entry on the table, which is within the claimed range. Even if, purely en arguendo, Fairman does not teach the required pH range (e.g. possibly because the teachings of Fairman regarding pH refer to the pH of an intermediate product rather than the final product), this is not sufficient to overcome the applied rejection. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a vaccine comprising a polysaccharide-polypeptide conjugate in the form of an aqueous solution have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of pH via routine experimentation.
As to claim 1, Fairman appears to teach all of the claimed requirements, albeit in separate embodiments. While the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 2, Fairman teaches a surfactant in paragraph 0533; this reads on the required emulsifier.
As to claim 3, Fairman teaches 2-amino-3-(4-azidophenyl)propanoic acid substitution in paragraph 0116.
As to claim 4, Fairman teaches a carrier protein as of at least paragraph 0040.
As to claim 5, Fairman teaches a capsular polysaccharide as of the abstract.
As to claim 6, Fairman teaches a capsular polysaccharide from Streptococcus pneumoniae in paragraph 0013.
As to claim 7, Fairman teaches a capsular polysaccharide from Streptococcus pneumoniae in paragraph 0013.
As to claim 8, Fairman teaches the following as of paragraphs 0029-0031, reproduced below.
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As to claim 9, the teachings from paragraphs 0029-0031 of Fairman which are reproduced above are understood to read on the claim requirement.
As to claim 10, Fairman teaches the following antigens as of paragraph 0234, relevant text reproduced below.
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These are understood to read on the claimed requirement. The examiner notes that the serotypes are not listed in the same order in Fairman as in the instant claims, with 7F being listed before 7C; nevertheless, the teachings of Fairman would appear to read on the requirements of instant claim 10.
As to claim 11, Fairman teaches a cell wall polysaccharide as of paragraphs 0260-0261.
As to claim 12, Seq. ID #1 of Fairman is understood to read on the required unsubstituted sequence because none of the natural amino acids are substituted with unnatural amino acids. This sequence is reproduced in part below from page 133 of Fairman; the sequence goes on to the top of page 135 of Fairman.
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Note the lack of “Xaa” amino acids in this sequence.
As to claim 13, Fairman teaches a sequence that is substituted with pAMF at multiple positions, as of paragraph 0104 of Fairman; the acronym pAMF refers to 2-amino-3-(4 (azidomethyl)phenyl) propanoic acid, as of paragraph 0010 of Fairman.
As to claim 14, the sequence described in paragraph 0104 of Fairman would appear to have at least two pAMF substitutions.
As to claim 15, Fairman teaches an exemplary modified CRM may include substitution of a nnAA (e.g. pAMF) at each of K33, K212, K244, K264, K385, and K526; this has six substitutions of the same non-natural amino acid.
As to claims 16-17, Seq ID #1 of Fairman, as of pages 133-135 of Fairman and reproduced above in the rejection of claim 12, would appear to read on the required sequence.
As to claim 18, Fairman teaches the following, as of Sequence #14, relevant text reproduced below from page 144 of Fairman.
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The examiner notes that the substitutions at sites 34, 213, 245, 386, and 527 appear to be the same substitution sites as in instant Seq. ID #2. While Fairman does not appear to specify a pAMF substitution in the text of the sequence ID, the skilled artisan would have been motivated to have used a pAMF substitution in view of at least the teachings of Fairman, paragraph 0104.
As to claims 19-20, Fairman teaches aluminum phosphate as of at least paragraphs 0518 and 0520-0521.
As to claim 21, Fairman teaches an aluminum concentration of ≤1 mg per mL, as of paragraphs 0523. This appears to overlap with the claimed concentration range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
In the alternative as to claim 21, Fairman teaches an aluminum phosphate adjuvant, but teaches a different concentration as compared with what is required by the instant claims. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality has been provided. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general condition of a vaccine comprising an aluminum phosphate adjuvant has been taught by the prior art. As such, it would not have bene inventive to have discovered the optimum or workable ranges of this ingredient via routine experimentation.
As to claim 22, Fairman teaches 15 mM potassium phosphate as of paragraph 1256. This appears to be within the claimed range.
As to claim 23, Fairman teaches 15 mM potassium phosphate as of paragraph 1256. This is slightly different from the 17 mM phosphate concentration required by the claim. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality has been presented. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a composition comprising a polypeptide, an aluminum adjuvant, a non-aluminum phosphate salt, and sodium chloride have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of these ingredients via routine experimentation.
As to claim 24, the claim requires about 150 mM of sodium chloride. Fairman teaches 0.9% sodium chloride in at least paragraph 1275. As best understood by the examiner, this is 0.154 M or 154 mM sodium chloride. This is understood to read on the claimed requirements.
As to claim 25, Fairman teaches compositions with pH values of 6.7 as of the first two lines of the table on page 123. However, elsewhere in the document, Fairman teaches a pH adjusting agent, as of Fairman, paragraph 0529, and also teaches a lower pH value of 5.5, as of Fairman, paragraph 0748. While the pH values taught by Fairman appear to differ from the claimed pH values, this is not sufficient to overcome the prima facie case of obviousness. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a composition comprising a polypeptide, an aluminum adjuvant, a non-aluminum phosphate salt, and sodium chloride have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of the pH of the composition via routine experimentation.
As to claim 26, Fairman teaches that the aluminum salt adjuvant is in the form of a suspension, as of paragraph 0534; otherwise, the composition is in a solution, as of paragraph 0524.
As to claim 27, Fairman teaches that aluminum adjuvants for stable porous aggregates of 1-10 microns in diameter, as of Fairman, paragraph 0524. As such, there would have been a reasonable expectation that the D50 of the aluminum adjuvants would have been 1-10 microns in diameter.
Note Regarding Reference Date: The instant application appears to have an earliest possible effective filing date of 2 September 2021, which is the filing date of provisional application 63/240,244. Fairman was published on 20 February 2020. As such, Fairman was published over a year earlier than the earliest effective filing date of the instant application. As such, Fairman is prior art under AIA 35 U.S.C. 102(a)(1). As Fairman was published over a year earlier than the effective filing date of the instant application, the exceptions under AIA 35 U.S.C. 102(b)(1)(A) and 102(b)(1)(B) would not appear to be applicable.
Relevant Prior Art – No Rejection
As relevant prior art, the examiner cites Fairman et al. (US 2018/0333484 A1). This reference appears to teach most of what is taught by Fairman et al. (US 2020/0054739 A1).
In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03. In this case, Fairman et al. (US 2018/0333484 A1) does not appear to be the best reference because, as best understood by the examiner, Fairman et al. (US 2018/0333484 A1) does not appear to teach a sequence which reads on Seq. ID #2, as required by instant claim 19. As such, no rejection over Fairman et al. (US 2018/0333484 A1) has been written by the examiner.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612