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 29 has been canceled. Claims 9, 18, and 19 have been amended. Claims 1, 2, 6-9, 18-21, 26, 27 and 29-37 are pending and under consideration.
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 19 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. The intended use of claim 19, alone or in combination with one or more medicaments, fails to further limit the subject matter of claim 18. The intended use does not impart any structural or chemical alterations to the pharmaceutical composition of claim 18 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.
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.
The rejection of claims 18-20 and 31 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 is maintained for reasons of record.
Claim 18 is vague and indefinite in the recitation of (i) the antibody or antigen-binding fragment thereof according to claim 1, (ii) an antibody conjugate, (iii) a multispecific antibody, (iv) a fusion protein, and optionally a pharmaceutically acceptable carrier and/or excipient because it is unclear whether all of (i)-(iv) must be present in the composition, or if (i)-(iv) are alternative embodiments.
Amendment of claim 18 to recite a ---pharmaceutical composition comprising a (i) an antibody or antigen-binding fragment thereof of claim 1, (ii) an antibody conjugate, (iii) a multispecific antibody, or (iv) a fusion protein, and a pharmaceutically acceptable carrier and/or excipient; wherein the antibody conjugate comprises the antibody of claim 1 and a conjugated moiety coupled thereto; wherein the multispecific antibody comprises the antibody of claim 1 and an antibody or antigen-binding fragment thereof against another antigen or antigenic epitope; and wherein the fusion protein comprises the antibody or antigen-binding fragment thereof of claim 1---would overcome this rejection.
The rejection of claim 1, in part, claim 27 and clams 18, 20, 21, 26, 29, 33, 34, 36 and 37 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of applicant’s submission of the Declaration of Yu Xia under 37 C.F.R. 1.132 and the letter from the China Center for Type Culture Collections.
The provisional rejection of claims 1, 2, 6-9, 18-21, 26, 27, 30, 31, 32, and 35 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/861,056 (reference application) is maintained for reason of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘056 application anticipate the instant claims.
Claims 1, 2 and 12 of the ‘056 application anticipate instant claims 1, 2 and 27 because (i) the heavy chain variable region of SEQ ID NO: 2 comprises the instant CDRs of SEQ ID NO: 9-11 and is identical to instant SEQ ID NO:2, and the light chain variable region of SEQ ID NO:4 comprises the CDRs of SEQ ID NO: 12-14 and is identical to instant SEQ ID NO:4; (ii) the heavy chain variable region of SEQ ID NO: 12 comprises the instant CDRs of SEQ ID NO: 9-11 and is identical to the instant SEQID NO: 22, and the light chain variable region of SEQID NO:14 comprises the instant CDRs of SEQ ID NO: 12-14 and is identical to the instant SEQ ID NO: 24; (iii) the heavy chain variable region of SEQ ID NO: 16 comprises the instant CDRs of SEQ ID NO: 9-11 and is identical to the instant SEQ ID NO: 26, and the light chain variable region of SEQID NO:18 comprises the CDRs of SEQ ID NO: 12-14 and is identical to the instant SEQ ID NO: 28; (iv) the heavy chain variable region of SEQ ID NO: 20 comprises the instant CDRs of SEQ ID NO: 9-11 and is identical to the instant SEQ ID NO: 30, and the light chain variable region of SEQID NO:22 comprises the CDRs of SEQ ID NO: 12-14 and is identical to the instant SEQ ID NO: 32; (v) the heavy chain variable region of SEQ ID NO: 24 comprises the instant CDRs of SEQ ID NO: 9-11 and is identical to the instant SEQ ID NO: 34, and the light chain variable region of SEQ ID NO:26 comprises the CDRs of SEQ ID NO: 12-14 and is identical to the instant SEQ ID NO: 36, all of which meet the same limitations in instant claim 2.
Claim 3 of the ‘056 application anticipates instant claim 3 because
SEQ ID NO: 27 is identical to instant SEQ ID NO: 49;
SEQ ID NO: 28 is identical to instant SEQ ID NO: 50;
SEQ ID NO: 29 is identical to instant SEQ ID NO: 51;
SEQ ID NO: 30 is identical to instant SEQ ID NO: 52;
SEQ ID NO: 31 is identical to instant SEQ ID NO: 53;
SEQ ID NO: 32 is identical to instant SEQ ID NO: 54;
SEQ ID NO: 33 is identical to instant SEQ ID NO: 55;
SEQ ID NO: 34 is identical to instant SEQ ID NO: 56;
SEQ ID NO: 35 is identical to instant SEQ ID NO: 65;
SEQ ID NO: 36 is identical to instant SEQ ID NO: 66;
SEQ ID NO: 37 is identical to instant SEQ ID NO: 67;
SEQ ID NO: 38 is identical to instant SEQ ID NO: 68;
SEQ ID NO: 39 is identical to instant SEQ ID NO: 69;
SEQ ID NO: 40 is identical to instant SEQ ID NO: 70;
SEQ ID NO: 41 is identical to instant SEQ ID NO: 71;
SEQ ID NO: 42 is identical to instant SEQ ID NO: 72;
SEQ ID NO: 43 is identical to instant SEQ ID NO: 73;
SEQ ID NO: 44 is identical to instant SEQ ID NO: 74;
SEQ ID NO: 45 is identical to instant SEQ ID NO: 75;
SEQ ID NO: 46 is identical to instant SEQ ID NO: 76;
SEQ ID NO: 47 is identical to instant SEQ ID NO: 77;
SEQ ID NO: 48 is identical to instant SEQ ID NO: 78;
SEQ ID NO: 49 is identical to instant SEQ ID NO: 79;
SEQ ID NO: 50 is identical to instant SEQ ID NO: 80;
SEQ ID NO: 51 is identical to instant SEQ ID NO: 81;
SEQ ID NO: 52 is identical to instant SEQ ID NO: 82;
SEQ ID NO: 53 is identical to instant SEQ ID NO: 83;
SEQ ID NO: 54 is identical to instant SEQ ID NO: 84;
SEQ ID NO: 55 is identical to instant SEQ ID NO: 85;
SEQ ID NO: 56 is identical to instant SEQ ID NO: 86;
SEQ ID NO: 57 is identical to instant SEQ ID NO: 87;
SEQ ID NO: 58 is identical to instant SEQ ID NO: 88;
SEQ ID NO: 59 is identical to both instant SEQ ID NO: 73 and 89;
SEQ ID NO: 60 is identical to both instant SEQ ID NO: 74 and 90;
SEQ ID NO: 61 is identical to both instant SEQ ID NO: 75 and 91;
SEQ ID NO: 62 is identical to both instant SEQ ID NO: 76 and 92;
SEQ ID NO: 63 is identical to instant SEQ ID NO: 93;
SEQ ID NO: 64 is identical to instant SEQ ID NO: 94;
SEQ ID NO: 65 is identical to instant SEQ ID NO: 95;
SEQ ID NO: 66 is identical to instant SEQ ID NO: 96;
which meet the same limitations in instant claim 3
Claims 4 and 5 of ‘056 anticipate instant claims 6 and 7. Claim 6 of ’056 anticipates instant claim 8. Claim 7 of ‘056 anticipates instant claim 9. Claim 8 of ‘056 anticipates instant claims 18-20. Claim 9 of ‘056 anticipates instant claim 21. Claim 10 of ‘056 anticipates instant claim 26 for the treatment of an allergic disease. Claim 8a of ‘056 renders obvious the antibody conjugate of the kit of claim 9 in ‘056, thus rendering obvious instant claims 32 and 35.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
All other rejections and/or objections as set forth or maintained in the prior Office action are withdrawn.
Allowable Subject Matter
Claims 33, 34, 36 and 37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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