The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4-15-2025 has been entered.
The amendment filed on 4-15-2025 is acknowledged. Claims 1, 3, 7, 9, 12, 14 and 48 have been amended. Claims 16 and 17 have been canceled. Claims 1, 3-4, 7, 9-10, 12-15, 18-20, 37, 39, 41 and 48 are pending. Claims 13, 15, 18-20, 37, 39 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1, 3-4, 7, 9-10, 12, 14 and 48 are currently under examination.
Claim Objections Maintained
Claims 1, 7, 12, 16 and 48 are objected to for reciting claim language drawn to a non-elected invention for the reasons set forth in the previous Office action in the rejection of claims 1, 7 and 16.
The amendment is insufficient to make said claim allowable and given that the restriction requirement among the linked inventions is subject to the non-allowance of the linking claim and that claim 1 is not allowable, the objection is valid and is maintained. Moreover, Applicant is reminded that the elected species is limited to the polypeptide of SEQ ID NO:21 (see page 9 for the response filed on 6-2-2020).
It should be noted the objection to claims 3-4, 9-10 and 16 for being dependent on a rejected claim is maintained for reasons of record as claim 1 is still not allowable.
New Claim Objections
Claim 7 is objected to for containing an obvious typographical error. Said claim is ended by both a semicolon and a period.
Claim Rejections Withdrawn
The rejection of claim 17 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. Cancellation of said claim has rendered the rejection moot.
Claims 1, 3-4, 7, 9-10, 12, 14, 16-17 and 48 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.
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "modified PfRH5 antigen" in line 3 is withdrawn in light of the amendment thereto.
The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "modified PfRH5 antigen" in line 1-2 is withdrawn in light of the amendment thereto.
The rejection of claim 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "modified PfRH5 antigen" in lines 1-2 is withdrawn in light of the amendment thereto.
The rejection of claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague term "and/or" is withdrawn in light of the amendment thereto.
The rejection of claim 9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague term "and/or" is withdrawn in light of the amendment thereto.
The rejection of claim 9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "modified PfRH5 antigen" in line 6 is withdrawn in light of the amendment thereto.
The rejection of claim 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "modified PfRH5 antigen" in line 6 is withdrawn in light of the amendment thereto.
The rejection of claim 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague term "PfRH5 antigen " is withdrawn in light of the amendment thereto.
The rejection of claim 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague term "PfRH5 antigen " is withdrawn in light of the amendment thereto.
New Grounds of Rejection
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 1, 3-4, 7, 9-10, 12, 14, 16-17 and 48 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.
Claim 1 is rendered vague and indefinite by the use of the phrase “… a modified Plasmodium falciparum Reticulocyte-binding protein Homologue 5 (PfRH5) antigen of a native PfRH5 amino acid sequence…”. It is unclear what is meant to be engendered by said phrase as an amino acid sequence constitutes and abstraction. It is suggested that the following language be used instead:
1. A composition comprising a modified Plasmodium falciparum Reticulocyte-binding protein Homologue 5 (PfRH5) antigen wherein:
said modified PfRH5 antigen comprises an amino acid substitution at positions corresponding to positions 183, 233, 381, 392, 398, 464 and 467 of SEQ ID NO: 1 or 2;
wherein each of positions corresponding to positions 183, 233, 381, 392, 398, 464 and 467 of SEQ ID NO: 1 or 2 is substituted by leucine, glutamic acid, phenylalanine, asparagine, alanine, lysine, isoleucine, aspartic acid, arginine, proline, or histidine; and
wherein the unmodified PfRH5 comprises an amino acid sequence having at least 95% sequence identity over the full length to SEQ ID NO: 1 or 2.
Claim 7 is rendered vague and indefinite by the use of the phrase “…the modified PfRH5 antigen further comprises an amino acid substitution at position:
(i) 157 is substituted by a leucine;
(ii) 183 is substituted by a glutamic acid;
(iii) 191 is substituted by an isoleucine;
(iv) 192 is substituted by an alanine;
(v) 233 is substituted by a lysine or asparagine;
(vi) 236 is substituted by a histidine;
(vii) 304 is substituted by a phenylalanine;
(viii) 308 is substituted by a lysine;
(ix) 312 is substituted by an asparagine;
(x) 314 is substituted by a phenylalanine;
(xi) 316 is substituted by an asparagine;
(xii) 330 is substituted by an asparagine;
(xiii) 369 is substituted by an asparagine;
(xiv) 370 is substituted by an alanine or lysine;
(xv) 381 is substituted by an asparagine;
(xvi) 384 is substituted by a lysine;
(xvii) 392 is substituted by a lysine or aspartic acid;
(xviii) 395 is substituted by an asparagine or arginine;
(xix) 398 is substituted by a glutamic acid or lysine;
(xx) 414 is substituted by a leucine;
(xxi) 444 is substituted by a glutamic acid;
(xxii) 445 is substituted by an aspartic acid;
(xxiii) 458 is substituted by a lysine;
(xxiv) 463 is substituted by an alanine;
(xxv) 464 is substituted by a lysine;
(xxvi) 467 is substituted by an alanine;
(xxvii) 470 is substituted by an arginine;
(xxviii) 474 is substituted by an aspartic acid;
(xxix) 495 is substituted by an asparagine;
(xxx) 505 is substituted by a leucine; or
(xxxi) 511 is substituted by a proline.
It is unclear what is meant to be engendered by said phrase as the independent claim already requires substitutions and positions 183, 233, 381, 392, 398, 464 and 467.
Claim 12 recites the limitation "native PfRH5 antigen" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
No claim is allowed.
SEQ ID NO:21 is free of the art of record.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 September 23, 2025