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 .
DETAILED ACTION
Applicant’s response filed on 03/11/2026 is duly acknowledged.
Claims 5, 6, 11 and 12 were previously canceled by applicants.
Claims 1-4, 7-10 and 13-18 as currently amended are currently pending in this application.
Claims 7-9 (non-elected Group II) remain withdrawn.
Claims 1-4, 10 and 13-18 (elected Group I and rejoined Group III; directed to “A mutant of an immunoglobulin-degrading enzyme IdeE…”, compositions, and Kits comprising the same), as currently amended have been examined on their merits in this action hereinafter.
Priority
This application is a 371 of PCT/CN2021/100844 (filed on 06/18/2021), which claims foreign priority from a Chinese application CN 202010557830.X (filed on 06/18/2020).
Specification Amendment
The amendment to specification as filed by applicants on 03/11/2026 is duly noted and entered on record.
Claims
The mutants of immunoglobulin-degrading enzyme IdeE have been interpreted to the extent of the particular amino acid sequences recited in the claims. Kit claims have been interpreted as comprising specific product components as recited in the claims.
Claim Objections -Withdrawn
In view of the current amendments to claims 16-18, the claim objections as previously made by the examiner, have been withdrawn.
Claim Rejections - 35 USC § 112- Withdrawn
In view of the current amendments to claims 2, 14-16 and 18, the 112b rejections as previously made by the examiner, have been withdrawn.
Claim Rejections - 35 USC § 102 -Withdrawn
In view of the current amendments to claim 1, the rejections under 102 over the cited prior art references of Lannergard et al (2006), and Kjellman et al (WO 2016/128559 A1), as previously made by the examiner, have been withdrawn.
Claim Rejections - 35 USC § 103- Withdrawn
In view of the current amendments to claim 1, the rejection under 103(a) over Kjellman et al (WO 2016/128559 A1) taken with Lannergard et al (2006) and Blumberg et al (2019), as previously made by the examiner, has been withdrawn.
Double Patenting - ODP Rejections Withdrawn
In view of current claim amendments and arguments presented by applicants (see REM dated 03/11/2026, p. 12-15), the ODP rejections over potentially conflicting claims of US 12,319,942 B2, and co-pending application 18/027,755, as previously made by the examiner, have been withdrawn as being later-filed applications.
The following contains new grounds of objections/rejections over pending claims as currently amended by applicants.
Claim Rejections - 35 USC § 112- New
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 1-4, 10 and 13-18 (as currently amended) 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 as currently has been reproduced below:
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It is to be noted that amended claim 1 now recites limitations for the mutant enzyme that “comprises a truncation of the immunoglobulin-degrading enzyme IdeE, by deleting the sequence of the first 15, the first 16, the first 17, the first 18 or the first 19 amino acids at its N-terminus; and a mutation selected from the group consisting of sections (1) and (2), wherein the section (1) recites “substitution of one or more of positions 8, 10, 24, 59, 97 and 280 of the amino acid sequence”, which is ambiguous and confusing. It is unclear as to what exactly is being encompassed by the product as currently being claimed. The enzyme IdeE as amended requires deletion of first 15 to first 19 amino acids from the N-terminus, and also requires the substitution of one or more of amino acids at positions 8 and 10, which according the first clause should have been deleted in said mutant protein variants. It is not clear as to how the specific portion of N-terminus that has been deleted can still have substitutions at positions 8 or 10, and still be part of the mutant IdeE enzyme as currently required by instant claim 1. Accordingly, the metes and bounds of the claimed product as currently amended does not appear to be properly defined.
In addition, instant claim 2 also recites the same limitations of “(1) substitution of one or more of positions 8, 10, 24, 59, 97 and 280 of the amino acid sequence as set forth in SEQ ID NO: 2, and…”, which again raises the same ambiguity as discussed above.
Also, instant claim 3 recites the sections (1) and (2) in a Markush group further qualifying the type of amino acid substitutions at positions 8 and 10, which does not clarify the product invention as claimed because of the same reasons as discussed above.
In addition, instant claim 4, recites the limitations “The mutant according to claim 3, wherein the mutant is as set forth in any one of SEQ ID NOs: 3-35 in the Sequence Listing”, wherein SEQ ID NOs: 3-8 (see instant SPEC, p. 22, Table 1) correspond to single substitutions in the wild-type (i.e. SEQ ID NO: 2) protein at positions 8 and 10 that are now deleted from the N-terminus of the protein. Therefore, it is unclear as to how the product of the amended claim 1 can correspond to “any one of SEQ ID NOs: 3-35” as currently required by the claim 4 (see also instant SPEC, p. 6, 2nd paragraph; and Table 3 on p. 24). Thus, the metes and bounds of the claimed product does not appear to be properly defined.
Since, none of the dependent claims clarify the above discussed issue of ambiguity, they are also rejected as being indefinite under 112b for the same reasons of record.
Appropriate correction/explanation is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 (as amended) is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 (Currently Amended) recites “The mutant according to claim 1, wherein the mutation is selected from the group consisting of:
(1) substitution of position 8, 10, 24, 59, 97 or 280 of the amino acid sequence as set forth in SEQ ID NO: 2; and
(2) deletion of the last 5 or the last 10 amino acids at the C-terminus of the immunoglobulin-degrading enzyme IdeE.”
It is noted that instant claim 2 recites a Markush group with sections (1) and (2) as reproduced above, wherein the recitation of section “(1) substitution of position 8, 10, 24, 59, 97 or 280 of the amino acid sequence as set forth in SEQ ID NO: 2” fails to further limit the scope of instant claim 1 as currently amended. In other words, if the mutant enzyme as per section (1) is selected, the scope of instant claims 1 and 2 would appear to be the same, which is improper scope for a dependent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Appropriate correction and/or explanation is required.
Examiner’s Response to Arguments
Applicant’s arguments with respect to claim(s) of record (REM filed on 03/11/2026) as currently presented have been considered but are moot in view of the new grounds of objection/rejection made in this office action, as discussed above.
Conclusion
NO claims are currently 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 SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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