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
Status of the Claims
1. Claims 1-47 are the original claims filed 8/3/2023. In the Preliminary Amendment of 8/3/2023, claims 1-47 are canceled and new claims 48-67 are added. In the Preliminary Amendment of 7/16/2025, claims 48-67 are canceled and new claims 68-74 are added.
Claims 68-74 are all the claims.
Priority
2. USAN 18/364,620, filed 08/03/2023, is a Continuation of 18/150,514, filed 01/05/2023, now U.S. Patent # 12404335, 18/150,514 is a Continuation of 17/822,978, filed 08/29/2022, now U.S. Patent # 11548951, 17/822,978 is a Continuation of 17/501,362, filed 10/14/2021, now abandoned, 17/501,362 Claims Priority from Provisional Application 63/261,742, filed 09/28/2021, 17/501,362 Claims Priority from Provisional Application 63/260,130, filed 08/10/2021,17/501,362 Claims Priority from Provisional Application 63/201,978, filed 05/21/2021,17/501,362 Claims Priority from Provisional Application 63/091,839, filed 10/14/2020. The priority filing date of 10/14/2020 is granted for the claimed invention.
Information Disclosure Statement
3. AS of 3/18/2026, a total of six (6) IDS are filed: 12/21/2023; 12/21/2023; 4/4/2024; 6/16/2025; 10/7/2025; and 10/7/2025. The corresponding initialed and dated 1449 form is considered and of record.
Objections
Specification
4. The disclosure is objected to because of the following informalities:
a) The use of the term, i.e., Alexa, GenBank, ATCC, nanobody/nanobodies, DARPin, Anticalin, Affimer, Vaccibody, DuoBody, Affibody, Affilin, FlowJo, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
b) The figures legends at [0041-0048] fail to define any aspect of what is shown in the corresponding Figure. The POSA is expected to interpret those data and any conclusions to be drawn therefrom for all of the Figures of this application.
c) The specification contains misspelling for the degree symbol “º” throughout.
Appropriate correction is required.
Claim Objections
5. Claims 68-74 are objected to because of the following informalities:
a) Amend claim 68 to recite “A pharmaceutical composition comprising an antibody for treating thyroid eye disease (TED) in a subject having TED and in need thereof, wherein the antibody comprises a light chain variable region having an amino acid sequence of SEQ ID NO: 13 and a heavy chain variable region having an amino acid sequence of SEQ ID NO: 14.
The specification teaches the meaning of treatment to encompass both a therapeutic and prophylactic beneficial result at
[0191] As used herein, “inhibit” or “treat” or “treatment” includes a postponement of development of the symptoms associated with a disorder and/or a reduction in the severity of the symptoms of such disorder. The terms further include ameliorating existing uncontrolled or unwanted symptoms, preventing additional symptoms, and ameliorating or preventing the underlying causes of such symptoms. Thus, the terms denote that a beneficial result has been conferred on a vertebrate subject with a disorder, disease or symptom, or with the potential to develop such a disorder, disease or symptom.
Appropriate correction 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.
6. Claim 74 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.
Sequence comparison of SEQ ID NO: 92 vs 95 where SEQ ID NO: 95 comprises C22S mutation and Fc YTE mutations:
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Sequence comparison of SEQ ID NO: 14 (Claim 68) vs SEQ ID NO: 95 (claim 74) shows SEQ ID NO: 95 comprises C22S mutation in the variable:
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Accordingly, where the sequence for the HCV of SEQ 14 is required for the antibody of claim 68, the generic claim does not identify a wild card for position C22 in the HCV sequence that otherwise corresponds to C22S for the HCV of SEQ ID NO: 95. Therefore, the portion of the VH region for the sequence of SEQ ID NO: 95 that in depending from claim 68, is broader in scope than the claim from which it depends.
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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claim(s) 68-69 and 72 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sherman et al. (US 20210253719, published 19 August 2021, filed 3 March 2021 and corresponding to Sherman et al. (WO 2021/041773, published 04 March 2021, filed 28 August 2020) as evidenced by Burak et al. (U.S. Patent No. 10,093,741).
Claim interpretation
VRDN-1100, VRDN-001 and AVE1642 correspond to the same anti- IGF-1R inhibitor antibody.
The claimed method invention is prima facie obvious over Sherman as evidenced by Burak in view of Hartmann as evidenced by Viridian.
As regards claim 68, Sherman discloses an IGF-1R inhibitor such as the antibody AVE1642 ([0057; 0062; 0098; 0099; 0201; 0229; Example 4) in a pharmaceutical composition to treat TED ([0165-166].
Sherman teaches a VH of SEQ ID NO: 78 that corresponds to instant SEQ ID NO: 14:
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Sherman teaches a VL of SEQ ID NO: 80 that corresponds to instant claimed SEQ ID NO: 13:
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Instant claim 68 recites the VRDN-1100 VL domain (SEQ ID NO: 13) that is identical to the AVE1642 VL domain (SEQ ID NO: 14) as taught in Burak:
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Instant claim 68 recite the VRDN-1100 VH domain (SEQ ID NO: 14) that is identical to the AVE1642 VH domain (SEQ ID NO: 8) as taught in Burak:
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The disclosure of the AVE1642 clone in the WO PCT application that shares identity with the instant claimed VDRN-1100 CDR1-3 sequences, renders those sequences inherent to the filing date of the WO PCT reference. Sherman WO PCT is effective prior art.
As regards claim 68, Sherman teaches the use the AVE1642 antibody in TED therapies as a pharmaceutical composition. See, for example, the specific citation and reference to the AVE1642 antibody taught throughout Sherman PCT.
Embodiment 57. The method of Embodiment 42 wherein the antibody is AVE1642.
[078] Embodiment 58. The method of Embodiment 57 wherein the AVE1642 is dosed at: a) 1-60 mg/kg or 75-4500 mg IV every 3 weeks; or b) 0.6-40 mg/kg or 45-3000 mg IV every 2 weeks; or c) 0.3-20 mg/kg or 22-1500 mg IV weekly.
[0122] Embodiment 100. The pharmaceutical composition of Embodiment 92, wherein the IGF-1R inhibitor is AVE1642, formulated for administration: a) 1-60 mg/kg or 75-4500 mg IV every 3 weeks; or b) 0.6-40 mg/kg or 45-3000 mg IV every 2 weeks; or c) 0.3-20 mg/kg or 22-1500 mg IV weekly.
[062] Embodiment 42. The method of Embodiment 40 wherein said antibody is chosen from ganitumab, figitumumab, MEDI-573, cixutumumab, dalotuzumab, robatumumab, AVE1642, BIIB022, xentuzumab, and istiratumab-----.
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AS regards claim 69, Sherman teaches half-life extending the anti-IGF-1R antibody by mutations in a Fc region for residues M428L and N434S at
[0243] Embodiment 121. The method of any of Embodiments 107-120, wherein the AVE1642 antibody further comprises a variant Fc region comprising mutations that substitute a methionine at position 428 with a leucine (Met428Leu) and substitute an asparagine at position 434 with a serine (Asn434Ser), wherein the amino acid substitution numbering is EU as in Kabat.
[0244] Embodiment 122. The method of any Embodiments 115-117, wherein the AVE1642 antibody further comprises a variant Fc region comprising mutations that substitute a methionine at position 428 with a leucine (Met428Leu) and substitute an asparagine at position 434 with a serine (Asn434Ser), wherein the amino acid substitution numbering is EU as in Kabat.
AS regards claim 72, Sherman discloses the antibody AVE1642, which as evidenced by Burak corresponds to instant SEQ ID NO: 93 and 92 for a light and heavy chains, respectively, and that are inherent to AVE1642. Burak discloses SEQ ID NO: 9 for the anti-IGF-1R antibody AVE1642. See column 28. This antibody is formed by fusing instant SEQ ID NO: 13 (amino acids 1-219 of SEQ ID NO: 9) to instant SEQ ID NO: 14 (amino acids 220-673 of SEQ ID NO: 9). See at least column 28 and SEQ ID NOS: 1-9.
The claimed invention is anticipated by Sherman as evidenced by Burak.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claim(s) 68-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman et al. (US 20210253719, published 19 August 2021, filed 3 March 2021 and corresponding to Sherman et al. (WO 2021/041773, published 04 March 2021, filed 28 August 2020) as evidenced by Burak et al. (U.S. Patent No. 10,093,741) and in view of HARTMANN et al (AU 2019200635; published 2019-02-21) as evidenced by Viridian (News Release VRDN-003, pp. 1-4 (6/11/2024)).
Claim interpretation
VRDN-1100, VRDN-001 and AVE1642 correspond to the same anti- IGF-1R inhibitor antibody.
The claimed method invention is prima facie obvious over Sherman as evidenced by Burak in view of Hartmann as evidenced by Viridian.
As regards claim 68, Sherman discloses an IGF-1R inhibitor such as the antibody AVE1642 ([0057; 0062; 0098; 0099; 0201; 0229; Example 4) in a pharmaceutical composition to treat TED ([0165-166].
Sherman teaches a VH of SEQ ID NO: 78 that corresponds to instant SEQ ID NO: 14:
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Sherman teaches a VL of SEQ ID NO: 80 that corresponds to instant claimed SEQ ID NO: 13:
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Instant claim 68 recites the VRDN-1100 VL domain (SEQ ID NO: 13) that is identical to the AVE1642 VL domain (SEQ ID NO: 14) as taught in Burak:
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Instant claim 68 recite the VRDN-1100 VH domain (SEQ ID NO: 14) that is identical to the AVE1642 VH domain (SEQ ID NO: 8) as taught in Burak:
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The disclosure of the AVE1642 clone in the WO PCT application that shares identity with the instant claimed VDRN-1100 CDR1-3 sequences, renders those sequences inherent to the filing date of the WO PCT reference. Sherman WO PCT is effective prior art.
As regards claim 68, Sherman teaches the use the AVE1642 antibody in TED therapies as a pharmaceutical composition. See, for example, the specific citation and reference to the AVE1642 antibody taught throughout Sherman PCT.
Embodiment 57. The method of Embodiment 42 wherein the antibody is AVE1642.
[078] Embodiment 58. The method of Embodiment 57 wherein the AVE1642 is dosed at: a) 1-60 mg/kg or 75-4500 mg IV every 3 weeks; or b) 0.6-40 mg/kg or 45-3000 mg IV every 2 weeks; or c) 0.3-20 mg/kg or 22-1500 mg IV weekly.
[0122] Embodiment 100. The pharmaceutical composition of Embodiment 92, wherein the IGF-1R inhibitor is AVE1642, formulated for administration: a) 1-60 mg/kg or 75-4500 mg IV every 3 weeks; or b) 0.6-40 mg/kg or 45-3000 mg IV every 2 weeks; or c) 0.3-20 mg/kg or 22-1500 mg IV weekly.
[062] Embodiment 42. The method of Embodiment 40 wherein said antibody is chosen from ganitumab, figitumumab, MEDI-573, cixutumumab, dalotuzumab, robatumumab, AVE1642, BIIB022, xentuzumab, and istiratumab-----.
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AS regards claim 69, Sherman teaches half-life extending the anti-IGF-1R antibody by mutations in a Fc region for residues M428L and N434S at
[0243] Embodiment 121. The method of any of Embodiments 107-120, wherein the AVE1642 antibody further comprises a variant Fc region comprising mutations that substitute a methionine at position 428 with a leucine (Met428Leu) and substitute an asparagine at position 434 with a serine (Asn434Ser), wherein the amino acid substitution numbering is EU as in Kabat.
[0244] Embodiment 122. The method of any Embodiments 115-117, wherein the AVE1642 antibody further comprises a variant Fc region comprising mutations that substitute a methionine at position 428 with a leucine (Met428Leu) and substitute an asparagine at position 434 with a serine (Asn434Ser), wherein the amino acid substitution numbering is EU as in Kabat.
AS regards claim 72, Sherman discloses the antibody AVE1642, which as evidenced by Burak corresponds to instant SEQ ID NO: 93 and 92 for a light and heavy chains, respectively, and that are inherent to AVE1642. Burak discloses SEQ ID NO: 9 for the anti-IGF-1R antibody AVE1642. See column 28. This antibody is formed by fusing instant SEQ ID NO: 13 (amino acids 1-219 of SEQ ID NO: 9) to instant SEQ ID NO: 14 (amino acids 220-673 of SEQ ID NO: 9). See at least column 28 and SEQ ID NOS: 1-9.
AS regards claim 71, Hartmann teaches specific mutations for Fc extending half-life of anti-IGF1-R antibodies through modification of the Fc domain to promote FcRn interaction by M252Y, S245Y and T256E (YTE). Figure 20 bolus application of 10 mg/kg into huFcRn transgenic male C57BL/6J mice +/- 276: AUC data for wild-type IgG as well as YTE and IHH-AAA Fc-modified IgGs; b) BIAcore sensorgram; c) FcRn affinity column elution; wild-type anti-IGF-lR antibody (reference), YTE-mutant of anti-IGF1R antibody, IHH-AAA-mutant of anti-IGF-lR antibody. Change of retention time in an FcRn affinity chromatography depending on the number of mutations introduced into the Fc-Region.
As evidenced by Viridian, the extension of the half-life for an Fc-modified anti-IGF-1R comprising the antigen binding domains of VRDN-001 for TED is motivated “to preserve the compelling IGF-1R clinical response we have seen in our earlier proof-of-concept studies of VRDN-001.”
As regards Claims 69-71, Sherman in view of Hartmann teaches in addition to FcRn interaction by M252Y, S245Y and T256E (YTE) for an IGF-lR antibody, the mutations for M428 and N434 are also candidate residues for half-life extension:
“Methods to increase IgG binding to FcRn have been performed by mutating IgG at various amino acid residues: Threonine 250, Methionine 252, Serine 254, Threonine 256, Threonine 307, Glutamic acid 380, Methionine 428, Histidine 433, and Asparagine 434 (see Kuo, T.T., et al., J. Clin. Immunol. 30 (2010) 777-789).”
AS regards claim 73, Hartmann as evidenced by Viridian teaches and suggests the introduction of M252Y, S245Y and T256E (YTE) into the Fc region of the VRDN-001 antibody heavy chain of SEQ ID NO: 94 (comparison of SEQ ID NO: 92 (native) vs SEQ ID NO: 94 (Fc half-life extension mutations):
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The combined reference teachings provide explicit use of the VRDN-1100 or VRDN-001 or AVE1642 anti- IGF-1R inhibitor antibody comprising a mutated Fc region to extend the half-life for the anti-IGF-R1 that comprises between M428L and N434S substitutions, M428L, N434S, M252Y, S254T, and T256E substitutions, or M252Y, S254T, and T256E substitutions. Because the antibody is established for use in TED therapy, and the sequence and functional properties for the claimed antibody are well established in the art, the POSA could predict with a reasonable degree of success that the mutation of a limited number of Fc domain residues taught as candidates by two separate references with limited number of amino acid substitutions for each of those residues could yield an extended half-life for the antibody.
The claims are prime facie obvious where the distinction in the making and the using of the method invention is based on the same antibody clone of the reference art but under a different assumed name.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 68 and 72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No 11548951 (continuation status). Although the claims at issue are not identical, they are not patentably distinct from each other because as regards claims 68 and 72: the ref patent species of SEQ ID NOs: 13 and 14 for the VH/VL domain of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NOs: 13 and 14; and the ref patent species of SEQ ID NOs: 93 and 92 for the light chain and the heavy chain, respectively, of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NOs: 93 and 92.
10. Claims 68, 71 and 73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No 12404335 (continuation status).
Although the claims at issue are not identical, they are not patentably distinct from each other because regards claims 68 and 71: the ref patent species of SEQ ID NOs: 93 and 94 the light chain and the heavy chain, respectively, of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NO: 13 and 14 comprising identical corresponding VLVH domains; the ref patent species of SEQ ID NOs: 93 and 94 the light chain and the heavy chain, respectively, of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NO: 13 and 14 comprising identical corresponding VLVH domains; the ref patent species of SEQ ID NOs: 93 and 94 the light chain and the heavy chain, respectively, of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NO: 93 and 94 comprising identical light and heavy chains.
As regards claim 71, the ref patent teaches and claims an Fc of for the sequence of SEQ ID NO: 94 comprising the substitutions M252Y, S254T, and T256E (within the sequence of SEQ ID NO: 92):
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11. Claims 68, 71 and 73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19/242,715 (reference application US 20250313639).
Although the claims at issue are not identical, they are not patentably distinct from each other because as regards claims 68, 71 and 73
the ref species of SEQ ID NOs: 13 and 14 for the VH/VL domain of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NOs: 13 and 14;
the ref species of SEQ ID NOs: 93 and 94 the light chain and the heavy chain, respectively, of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NO: 93 and 94 comprising identical light and heavy chains.
the ref teaches and claims an Fc of for the sequence of SEQ ID NO: 94 comprising the substitutions M252Y, S254T, and T256E (within the sequence of SEQ ID NO: 92).
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the ref for Fc region of the sequence of SEQ ID NO: 89 anticipates and/or renders obvious the instant claimed sequence of SEQ ID NO: 94 with 100% identity for a corresponding region:
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claims 68, 71 and 73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/242,725 (reference application US 20250382374).
As regards claims 68 and 71: the ref species of SEQ ID NOs: 93 and 94 the light chain and the heavy chain, respectively, of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NO: 13 and 14 comprising identical corresponding VLVH domains; the ref species of SEQ ID NOs: 93 and 94 the light chain and the heavy chain, respectively, of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NO: 93 and 94 comprising identical light and heavy chains.
As regards claim 71, the ref teaches and claims an Fc of for the sequence of SEQ ID NO: 94 comprising the substitutions M252Y, S254T, and T256E (within the sequence of SEQ ID NO: 92):
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. Claims 68 and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 20-27 of copending Application No. 18/942,051 (reference application US 20250059287).
Although the claims at issue are not identical, they are not patentably distinct from each other because as regards claims 68 and 72: the ref species of SEQ ID NOs: 13 and 14 for the VH/VL domain of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NOs: 13 and 14; and the ref species of SEQ ID NOs: 93 and 92 for the light chain and the heavy chain, respectively, of the VRDN-1100 (anti-IGF-IR) clone anticipate and/or render obvious the instant claimed sequences of SEQ ID NOs: 93 and 92. The CDR sequences in ref claim 1 are inherent to the ref species of SEQ ID NOs: 13 and 14 for the VH/VL domain of the VRDN-1100 (anti-IGF-IR) clone.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 68 and 72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US 12404337. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim sets encompass the VH/VL CDR1-3 and VH/VL domains for the anti-IFR-R1 antibody clone (VRDN-1100 or VRND-001 (or AVE1642 or EM164)) that comprises: a light chain variable region having the amino acid sequence of SEQ ID NO: 13 that corresponds to ref SEQ ID NO: 2; a heavy chain variable region having the amino acid sequence of SEQ ID NO: 14 that corresponds to ref SEQ ID NO: 3; a heavy chain of SEQ ID NO: 92 that corresponds to ref SEQ ID NO: 10; a light chain of SEQ ID NO: 93 that corresponds to ref SEQ ID NO: 11.
15. Claims 68 and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 4-5, 27-29, 31, 51, and 56 of copending Application No. 18/827,383 (reference application US 20250099583).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim sets are drawn to the VRDN-1100 antibody that comprises the VL CDR1-3 (RSSQSIVHSNVNTYLE (SEQ ID NO 53); KVSNRFS (SEQ ID NO: 54); FQGSHVPPT (SEQ ID NO: 55) and the VH CDR1-3 (SYWMH (SEQ ID NO: 56); GEINPSNGRTNYNQKFQG (SEQ ID NO: 57); GRPDYYGSSKWYFDV (SEQ ID NO:58)); the VRDN-1100 VL (SESQ ID NO: 13) and VH (SEQ ID NO: 14); the VRDN-1100 LC (SEQ ID NO: 93) and HC (SEQ ID NO: 94).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
16. No claims are allowed.
17. The following is pertinent but not effective art to the claims: US 20240368282 (BIOSCEPTRE (AUST) PTY LTD; filed 9/1/2021; USAN 18/688,086) and teaching both instant claimed SEQ ID NOS: 13 and 14 as SEQ ID NOS: 200 and 201, respectively.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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