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
Applicant’s amendments and remarks, filed 04/28/2026, are acknowledged.
Claims 4, 6-9, 11, and 20-22 are canceled.
Claims 1-3, 5, 10, 12-13, and 17-19 are amended.
Claims 23-31 are new.
Claims 1-3, 5, 10, 12-19, and 23-31 are pending.
Claims 14-16, 18-19, and 28-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/22/2025.
As such, claims 1-3, 5, 10, 12-13, 17, and 23-27 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Withdrawn Objections
The drawing objection is withdrawn. The issue regarding Figure 3 reciting sequences with no SEQ ID NO. has been sufficiently addressed through amendments to the drawings on 04/28/2026.
The specification objections are withdrawn. Issues regarding minor informalities, sequences recited without a SEQ ID NO., and trademarks/names have been sufficiently addressed through amendments to the specification on 04/28/2026.
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 04/28/2026.
Withdrawn Rejections
Applicant’s arguments, see page 18, filed 04/28/2026, with respect to claim 21 rejected under 35 USC 112(d) as allegedly being of improper dependent form have been fully considered and are persuasive. The issue regarding improper dependent subject matter have been sufficiently addressed through amendments to the claim(s); specifically, Examiner acknowledges that claim 21 was canceled thus rendering the rejection moot.
Applicant’s arguments, see pages 18 and 19, filed 04/28/2026, with respect to claims 1-13, 17, and 20-22 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 4, 6-9, 11, and 20-22 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s arguments, see pages 19-21, filed 04/28/2026, with respect to claims 1-13, 17, and 20-22 rejected under 35 USC 112(a) as allegedly lacking written description have been fully considered and are persuasive. The issue regarding the specification failing to disclose Applicant’s possession of the large genus of anti-AREG antibodies or fragments thereof described by function or partial structure have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 4, 6-9, 11, and 20-22 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(a) is withdrawn.
Applicant’s remarks, see page 21, filed 04/28/2026, with respect to claims 1-5, 13, 17, and 20-22; claims 1-8, 17, and 20-22; and, claims 1-8, 17, and 20-22 rejected under 35 USC 102 as allegedly anticipated by Landolfi, Caswell, and Yarden, respectively, have been fully considered and are persuasive. Examiner acknowledges that claims 4, 6-9, 11, and 20-22 are canceled, thus rendering the rejection moot. Further, Examiner acknowledges that claims 1-3, 5, 10, 12-13, and 17-19 were amended to recite six CDR sequences (three for VH and three for VL) which is not disclosed by the cited art. As such, the 35 USC 102 rejections are withdrawn.
Applicant’s remarks, see pages 21 and 22, filed 04/28/2026, with respect to claims 1-13 and 17 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 17/614,673 have been fully considered and are persuasive. Examiner acknowledges that claims 4, 6-9, and 11 are canceled, thus rendering the rejection moot. Further, Examiner acknowledges that claims 1-3, 5, 10, 12-13, and 17-19 were amended to recite six CDR sequences (three for VH and three for VL) which is not claimed by the copending application. As such, the provisional double patenting rejection over copending Application No. 17/614,673 is withdrawn.
New Objections and Rejections Necessitated by Amendment
Claim Objections
Claims 3 and 10 are objected to because of the following informalities:
Claim 3 recites “a Fab fragment” twice.
Between Claim 10(13) and Claim(14), Applicant should remove “comprising the amino acid sequence shown by”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
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.
Claims 10 and 12 are 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 1 is drawn to an isolated anti-Amphiregulin (AREG) antibody or antigen binding fragment thereof, having the ability of inhibiting fibrosis, comprising: a heavy chain variable region comprising heavy chain complementarity determining regions (HCDRs): HCDR1 comprising the amino acid sequence shown by SEQ ID NO: 1, HCDR2 comprising the amino acid sequence shown by SEQ ID NO: 15, and HCDR3 comprising the amino acid sequence shown by SEQ ID NO: 16, and a light chain variable region comprising light chain complementarity determining regions (LCDRs): LCDR1 comprising the amino acid sequence shown by SEQ ID NO: 47, LCDR2 comprising the amino acid sequence shown by SEQ ID NO: 44, and LCDR3 comprising the amino acid sequence shown by SEQ ID NO: 46.
Claims 10 and 12 depend from claim 1, but recite different CDR sequences or VH/VL sequences that do not comprise the CDR sequences of claim 1. As such, claims 10 and 12 broaden the scope of claim 1.
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.
Maintained Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
18/688,572
Claims 1-3, 5, 10, 12-13, 17, and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-10, 15, 18-20, 22, 25-26, 33, and 35-36 of copending Application No. 18/688,572 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The ‘572 application is drawn to a bi-functional fusion protein comprising a first domain and a second domain, wherein the first domain is capable of binding to AREG or a fragment thereof, preferably is an antibody or an antigen-binding fragment thereof that binds to AREG or a fragment thereof, and the second domain is capable of binding to a TGF ligand or a fragment thereof, preferably comprises a part of the ectodomain of TGFO receptor II (TRII) or a variant thereof (see claim 1).
The ‘572 application is drawn to the bi-functional protein of claim 1, wherein the antibody or the antigen-binding fragment thereof, binding to both human AREG and mouse AREG, alternatively, the anti-AREG antibody or the fragment thereof is capable of binding to human AREG with weak or without cross-reactivity to mouse AREG, and/or wherein the anti-AREG antibody or the fragment thereof is a human anti-AREG antibody, a murine anti-AREG antibody, a chimeric anti-AREG antibody, or a humanized anti-AREG antibody, preferably, is a human monoclonal antibody (mAb), murine mAb, chimeric mAb or humanized mAb, and/or wherein the anti-AREG antibody or the fragment thereof is capable of binding to a soluble form of AREG, preferably, is capable of binding to an epidermal growth factor (EGF)-like domain of the soluble form of AREG, and/or wherein the anti-AREG antibody or the fragment thereof is an isotype of IgG, IgM, IgA, IgE, IgD or a variant thereof, preferably, an isotype of IgG1, IgG2, IgG3, IgG4 or a variant thereof (see claim 4).
The ’572 application is drawn to the bi-functional fusion protein of claim 1, wherein the anti- AREG antibody or the fragment thereof comprises a heavy chain variable region comprising heavy chain complementarity determining regions HCDR1, HCDR2, and HCDR3, and a light chain variable region comprising light chain complementarity determining regions LCDR1, LCDR2, and LCDR3, wherein:HCDR1, HCDR2, and HCDR3 are selected from a group consisting of: (1) HCDR1: SYAMS (SEQ ID NO: 1), HCDR2: AISGSGGSTYYADSVKG (SEQ ID NO: 2), HCDR3: PTSRYSYGYDY (SEQ ID NO: 3);(2) HCDR1: SYAMS (SEQ ID NO: 1), HCDR2: AISGSGGSTYYADSVKG (SEQ ID NO: 2), HCDR3: PTSRYSYSYNN (SEQ ID NO: 4);(3) HCDR1: SHAMS (SEQ ID NO: 5), HCDR2: AISGSGGSTYYADSVKG (SEQ ID NO: 2), HCDR3: VDTKFDP (SEQ ID NO: 6);(4) HCDR1: SYPMS (SEQ ID NO: 7), HCDR2: TISTGGTYTYYPDSVKG (SEQ ID NO: 8), HCDR3: QGPIYYGNYYYAMDY (SEQ ID NO: 9);(5) HCDR1: SYPMS (SEQ ID NO: 7), HCDR2: TISTGGRYTYYPDSVKG (SEQ ID NO: 10), HCDR3: QGPIYYGNYYYAMDY (SEQ ID NO: 9);(6) HCDR1: SYPMS (SEQ ID NO: 7), HCDR2: TISTGGTYTYYPDSVKG (SEQ ID NO: 8), HCDR3: QGPILRKNYYYGMDV (SEQ ID NO: 11);(7) HCDR1: SYPMS (SEQ ID NO: 7), HCDR2: TISTGGTYTYYPDSVKG (SEQ ID NO: 8), HCDR3: QGPIYYGNYYYGMDV (SEQ ID NO: 12);(8) HCDR1: SYAMS (SEQ ID NO: 1), HCDR2: TISTGGSHTYYPDSVKG (SEQ ID NO: 13), HCDR3: HGYLLYDGYYEWYFDV (SEQ ID NO: 14);(9) HCDR1: SYAMS (SEQ ID NO: 1), HCDR2: TISTGGSHTYYPDSVKG (SEQ ID NO: 13), HCDR3: HGYLLYDGYYEWYFDY (SEQ ID NO: 140);(10) HCDR1: SYAMS (SEQ ID NO: 1), HCDR2: TISTGGSHTYYPESVKG (SEQ ID NO: 15), HCDR3: HGYLLYEGYYEWYFDY (SEQ ID NO: 16);(11) HCDR1: GYPMS (SEQ ID NO: 17), HCDR2: TISTGARHTYYPDSVKG (SEQ ID NO: 18), HCDR3: HEGLRRGKYHCIMDY (SEQ ID NO: 19);Attorney Docket No. 0487.0001-US (12) HCDR1: GYPMS (SEQ ID NO: 17), HCDR2: TISTGARHTYYPDSVKG (SEQ ID NO: 18), HCDR3: HEGLRRGKYHSIMDY (SEQ ID NO: 20); and(13) HCDR1, HCDR2, HCDR3 as shown in (1)-(12), but at least one of which includes one, two, three, four or five amino acids addition, deletion, conservative amino acid substitution or the combinations thereof; and LCDR1, LCDR2, and LCDR3 are selected from a group consisting of[AltContent: ]1) LCDR1: TGNSNNVGDQGAV (SEQ ID NO: 21), LCDR2: RNNNRPS (SEQ ID NO: 22), LCDR3: STWDSGLNSVV (SEQ ID NO: 23);(2) LCDR1: TGNSNNVGDQGAV (SEQ ID NO: 21), LCDR2: RNNNRPS (SEQ ID NO: 22), LCDR3: STWDKNNKSVV (SEQ ID NO: 24);(3) LCDR1: SGSSSNIGSNTVN (SEQ ID NO: 25), LCDR2: SNNQRPS (SEQ ID NO: 26), LCDR3: EVWDDSLNGPV (SEQ ID NO: 27); (4) LCDR1: RSSQSLVHSDGNTYLH (SEQ ID NO: 28), LCDR2: KVSNRFS (SEQ ID NO: 29), LCDR3: SQSTHVPYT (SEQ ID NO: 30);(5) LCDR1: RSSQSLVDGEDGTYLN (SEQ ID NO: 31), LCDR2: KVSERFD (SEQ ID NO: 32), LCDR3: SQSTHVPYT (SEQ ID NO: 30);(6) LCDR1: RSSQSLVDGQDGTYLH (SEQ ID NO: 33), LCDR2: KVSNRFD (SEQ ID NO: 34), LCDR3: SQSTHVPYT (SEQ ID NO: 30);(7) LCDR1: RSSQSLVNQEGETYLH (SEQ ID NO: 35), LCDR2: KVSNRFD (SEQ ID NO: 34), LCDR3: SQSTHVPYT (SEQ ID NO: 30);(8) LCDR1: KASQSVDYDGHSFLN (SEQ ID NO: 36), LCDR2: AASNLES (SEQ ID NO: 37), LCDR3: QQSTEDPPYT (SEQ ID NO: 38);(9) LCDR1: RASESVDYDGHSFIN (SEQ ID NO: 39), LCDR2: AASNKDT (SEQ ID NO: 40), LCDR3: QQSTEDPPYT (SEQ ID NO: 38);(10) LCDR1: RASQSVDYDGHSFLN (SEQ ID NO: 41), LCDR2: AASNLQS (SEQ ID NO: 42), LCDR3: QQSTEDPPYT (SEQ ID NO: 38);(11) LCDR1: KSSQSVDYDGHSFLN (SEQ ID NO: 43), LCDR2: AASNRES (SEQ ID NO: 44), LCDR3: QQSTEDPPYT (SEQ ID NO: 38);(12) LCDR1: RASESVDYDGHSFIN (SEQ ID NO: 39), LCDR2: AASNKDT (SEQ ID NO: 40), LCDR3: QQSTEDPPYT (SEQ ID NO: 38);Attorney Docket No. 0487.0001-US (13) LCDR1: RASQSVDYEGHSFLN (SEQ ID NO: 45), LCDR2: AASNLQS (SEQ ID NO: 42), LCDR3: QQSTENPPYT (SEQ ID NO: 46);(14) LCDR1: KSSQSVDYEGHSFLN (SEQ ID NO: 47), LCDR2: AASNRES (SEQ ID NO: 44), LCDR3: QQSTENPPYT (SEQ ID NO: 46);(15) LCDR1: KASQSIDYDGDSFLN (SEQ ID NO: 48), LCDR2: AASNLES (SEQ ID NO: 37), LCDR3: HQCNEDPYM (SEQ ID NO: 49);(16) LCDR1: RASESVDYDGDSFIN (SEQ ID NO: 50), LCDR2: AASNKDT (SEQ ID NO: 40), LCDR3: HQSNEDPYM (SEQ ID NO: 51);(17) LCDR1: RASESVDYDGDSFIN (SEQ ID NO: 50), LCDR2: AASNKDT (SEQ ID NO: 40), LCDR3: HQSNEDPYL (SEQ ID NO: 52);(18) LCDR1: RASESVDYDGDSFIN (SEQ ID NO: 50), LCDR2: AASNKDT (SEQ ID NO: 40), LCDR3: HQSNEDPYV (SEQ ID NO: 53);(19) LCDR1: RASQSIDYDGDSFLN (SEQ ID NO: 54), LCDR2: AASNLQS (SEQ ID NO: 42), LCDR3: QQSNEDPYV (SEQ ID NO: 55);(20) LCDR1: KSSQSIDYDGDSFLN (SEQ ID NO: 56), LCDR2: AASNRES (SEQ ID NO: 44), LCDR3: QQSNEDPYV (SEQ ID NO: 55); and(21) LCDR1, LCDR2, LCDR3 as shown in (1)-(20), but at least one of which includes one, two, three, four or five amino acids addition, deletion, conservative amino acid substitution or the combinations thereof (see claims 7 and 8).
The ’572 application is drawn to the bi-functional fusion protein of claim 1, wherein the anti- AREG antibody or the fragment thereof comprises a heavy chain variable region, and a light chain variable region, wherein the heavy chain variable region has an amino acid sequence selected from a group consisting of SEQ ID Nos: 57-69, and an amino acid sequence having at least 95% sequence identity to any one of SEQ ID Nos: 57-69, and retaining epitope-binding activity, wherein the light chain variable region has an amino acid sequence selected from a group consisting of SEQ ID Nos: 70-89, and an amino acid sequence having at least 95% sequence identity to any one of SEQ ID NOs: 70-89, and retaining epitope-binding activity (see claims 9 and 10).
The sequences recited in the ‘572 application share 100% identity with the sequences of the present application with the same SEQ ID NO.
The ‘572 application is drawn to a pharmaceutical composition, comprising the bi-functional fusion protein of claim 1 and a pharmaceutically acceptable carrier (see claim 33).
Lastly, the ‘572 application is drawn to a method for preventing, treating and/or diagnosing fibrotic diseases, cancers and diseases associated with chronic inflammation in a subject, which comprises administering to a subject a therapeutically effective amount of the bi-functional fusion protein of claim 1, or of the pharmaceutical composition of claim 33, preferably, the fibrotic diseases include renal fibrosis, hepatic fibrosis, pulmonary fibrosis, in particular, idiopathic pulmonary fibrosis (IPF) (see claims 35 and 36).
The difference between the instant claims and the ‘572 application is that the ‘572 application is drawn to methods of using the claimed anti-AREG proteins. However, the Federal Circuit has held that obviousness-type double patenting exists for method claims that simply claim the disclosed use of a composition in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). The instant application and the copending application are not divisional applications resulting from restriction, and therefore no protection under the provisions of 35 USC 121.
As such, the ‘572 application anticipates the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Arguments
Applicant respectfully requests reconsideration and withdrawal of the double patenting rejection. Without acquiescing to the Office's position, claim 1 has been amended to recite the specific amino acid sequences of HCDR1-3 and LCDR1-3, and claims 20-22 has been canceled. Such amendments have distinguished the instant claims from copending Application Nos. 18/688,572 or 17/614,673. Additionally, Applicant respectfully submits that the present claims are patentably distinct from those of the '572 application because the '572 claims are expressly limited to bi-functional fusion proteins comprising both an anti-AREG antibody and a TGF3 ligand as a single fusion molecule. In contrast, the pending claims are directed to the anti-AREG antibody or antigen binding fragment alone, without any requirement for fusion to another domain or combination with additional polypeptide sequences. The additional structural and functional limitations imposed by the fusion protein claims in '572 are absent from the present claims.
Response to Arguments
Applicant's arguments filed 04/28/2026 have been fully considered but they are not persuasive. The Examiner acknowledges the amendments to the present claims. However, the amendments do not overcome the double patenting rejection of the present claims because the bi-functional fusion protein of the ‘572 application comprises an antibody or antigen-binding fragment comprising the CDR sequences and consequent VH/VL sequences of the present invention. Further, the present invention utilizes the language “comprising” which is an open-ended transitional phrase; thus, the present invention is not limited to a single-functional protein. As such, the ‘572 application is not patentably distinct from the present invention.
Applicant is reminded that a rejection under double patenting precludes the identification of allowable subject matter. Applicant has not filed a terminal disclaimer, and the claims remain rejected for reasons set forth above.
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As such, the provisional double patenting rejection is maintained.
Allowable Subject Matter
The sequences recited in claims 1, 10, 12, and 26 appear to be free of the art. The closest prior art is Rosen et al (US 2003/0175274 A1; publication date: 09/18/2003) which disclose of human VEGF-2 antibodies, antibody fragments, or variants thereof (see Abstract). Specifically, Rosen et al disclose of SEQ ID NO: 81 which shares 72.8% identity with instant SEQ ID Nos: 5, 2, and 6 (see alignment below).
SEQ ID Nos: 5, 2, and 6 Alignment
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Conclusion
No claims are 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 DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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