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 .
Claim Status
The amended claim set filed on 26 November 2025 is acknowledged. Claims 1-2, 5-8, 10-11, 13-15, and 19 are currently pending. Of those, claims 1, 5, and 10-11 are amended. Claim 19 is new, and claims 13-15 are withdrawn. Claims 3-4, 9, 12, and 16-18 are cancelled. Claims 1-2, 5-8, 10-11, and 19 will be examined on the merits herein.
Response to Amendment
The Applicants’ arguments filed 26 November 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 2 September 2025 will be referred to “NFOA”.
Objection(s) and Rejection(s) Withdrawn
The objection to the drawings is withdrawn in view of the replacement drawings filed 26 November 2025.
The nucleotide and/or amino acid sequence disclosure deficiency is corrected by the replacement drawings filed 26 November 2025.
The objection to the specification is withdrawn in view of the substitute specification filed 26 November 2025.
The objection to claim 1 is withdrawn in view of the amendments to the claim.
The rejections of claims 3-4, 9, 12, and 16-18 under 35 U.S.C. 112(b) and/or 112(a) are moot because those claims are cancelled.
The rejection of claim 11 under 35 U.S.C. 112(a) for failing to meet the enablement requirement is withdrawn in view of the amendments to the claim.
The rejection of claims 1-2, 5-8, and 10-11 under 35 U.S.C. 112(a) for failing to meet the written description requirement is withdrawn in view of the amendments to the claims.
New Objection(s)
Specification
The amendment filed 26 November 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The SEQ ID NO: 29 in the sequence listing submitted on 26 November 2025 does not match any sequence taught in the disclosure. The sequence listing states that residue 14 of SEQ ID NO: 29 may be any naturally occurring amino acid, but the amino acid sequence on pg. 3 of the instant specification says that residue 14 is glycine (G).
Applicant is required to cancel the new matter in the reply to this Office Action.
New Rejection(s)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(a)
Claims 1-2, 5-8, 10-11, and 19 are newly rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 1 (upon which claims 2, 5-8, and 19 depend) and 10-11 have been amended to recite an antibody comprising: “a) a heavy chain Complementary Determining Region 3 (CDRH3) loop comprising amino acid no. 115 to 132 of SEQ ID NO: 17: a CDRH2 comprising amino acid no. 70 to 77 of SEQ ID NO: 17: and a CDRH1 comprising amino acid no. 45 to 52 of SEQ ID NO: 17; and b) a light chain Complementary Determining Region 3 (CDRL3) loop comprising amino acid no. 109 to 123 of SEQ ID NO: 21: a CDRL2 comprising amino acid no. 69 to 71 of SEQ ID NO: 21: and a CDRL1 comprising amino acid no. 46 to 51 of SEQ ID NO: 21” but there does not appear to be a written description of the claim limitation “a heavy chain… CDRH2 comprising amino acid no. 70 to 77 of SEQ ID NO: 17: and a CDRH1 comprising amino acid no. 45 to 52 of SEQ ID NO: 17… and a light chain… CDRL2 comprising amino acid no. 69 to 71 of SEQ ID NO: 21: and a CDRL1 comprising amino acid no. 46 to 51 of SEQ ID NO: 21” in the application as filed.
The instant specification describes four antibodies, referred to as Ab25, Ab26, Ab32, and Ab49. The specification identifies SEQ ID NOs: 1-4 as CDR H3 loops and SEQ ID NOs: 5-8 as CDR L3 loops (para. 91 and 94). Ab25 comprises SEQ ID NO: 17 as the heavy chain, which comprises SEQ ID NO: 1 as CDR H3 loop, and SEQ ID NO: 21 as the light chain, which comprises SEQ ID NO: 5 as CDR L3 (para. 102). Ab26 comprises SEQ ID NO: 18 as the heavy chain, which comprises SEQ ID NO: 2 as CDR H3 loop, and SEQ ID NO: 22 as the light chain, which comprises SEQ ID NO: 6 as CDR L3 loop (para. 102). Ab32 comprises SEQ ID NO: 19 as the heavy chain, which comprises SEQ ID NO: 3 as CDR H3 loop, and SEQ ID NO: 23 as the light chain, which comprises SEQ ID NO: 7 as CDR L3 loop (para. 102). Ab49 comprises SEQ ID NO: 20 as the heavy chain, which comprises SEQ ID NO: 4 as CDR H3 loop, and SEQ ID NO: 24 as the light chain, which comprises SEQ ID NO: 8 as CDR L3 loop (para. 102). Of these four antibodies, only three of these antibodies (Ab25, Ab32, and Ab49; Ab26 was not tested) were shown in the specification as capable of binding streptococcal M protein (para. 329). The instant specification does not teach the amino acid sequences of any CDR1s or CDR2s on any heavy or light chains; nor does it teach what regions of the disclosed heavy and light chains correspond to CDR1s and CDR2s. The instant specification also does not provide any guidance on how to obtain the CDR1s and CDR2s from the disclosed sequences using any of the variety of different method known in the art capable of predicting CDR sequences.
It is noted that Applicant did not point to support in the specification, by paragraph or page and line number, for the new limitations recited in the amended claims, but only stated that “Support for the new claims and amendments can be found throughout the specification and in the claims as originally filed” (see Remarks, pg. 8).
Accordingly, the newly added limitations constitute new matter.
Conclusion
No claim is allowed.
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 BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645