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
The amendment filed on 3-25-2026 is acknowledged. Claims 1, 7, 12 and 14 have been amended. 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 Claims 13, 15, 18-20, 37, 39 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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Claim Objections Withdrawn
The objection to claim 7 for containing an obvious typographical error is withdrawn in light of the amendment thereto.
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 of 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.
Claim Rejections Withdrawn
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite for the use of the phrase “… a modified Plasmodium falciparum Reticulocyte-binding protein Homologue 5 (PfRH5) antigen of a native PfRH5 amino acid sequence…” is withdrawn in light of the amendment thereto.
The rejection of claim & under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite for 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.” 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 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 “… at least 95% sequence identity over the full length to SEQ ID NO:1 or 2, or a fragment thereof that is at least 250 amino acids in length.”. It is unclear what is meant to be engendered by said phrase. It is unclear whether the fragment language is referring to the modified or unmodified PfRH5 antigen. If the latter is the case, the specific residues recited in the claim have not real meaning as they are not predicated a specific base sequence. As written, it is impossible to determine the metes and bounds of the claimed invention.
Conclusion
No claim is allowed.
SEQ ID NO:21-28, 35-42 and 49-56 are free of the art of record.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached on Monday thru Friday; 6:30 am - 3pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair.
Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 May 30, 2026
Prosecution Insights