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 .
Applicant's arguments filed 4/16/2026 have been fully considered but they are not persuasive.
The rejection of claims 1, 11, 19-24, and 29 under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al. (WO 03/106621) is withdrawn in view of the claim amendments. The CDRs recited in instant claim 3 are not disclosed in Singh et al.
Election/Restrictions
Claims 25-28 and 30-34 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/1/2025.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 as amended contains what appears to be a typographical/word processing error: “acide.” Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claims 3, 6, 8-24, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanokura et al. (WO 2020/116398, of record) and are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tanokura et al. (WO 2020/116398, of record), Tanokura et al. (U.S. Patent Application Publication 2022/0033485, of record), and Tanokura et al. (U.S. Patent No. 12,227,563).
All of the references remain valid prior art for the reasons set forth in the prior Office action. The effective filing date of the instant application is 1 June 2021. Applicant cannot rely upon the certified copy of the foreign priority application JP 2020-096344 because a translation of said application has not been made of record in accordance with 37 CFR 1.55 as set forth in the prior Office action.
Tanokura et al. (U.S. Patent Application Publication 2022/0033485) will be referenced for the reasons set forth in the prior Office action.
Independent claim 3 as amended requires heavy-chain and light-chain framework regions (FR) derived from a human antibody and wherein the amino acid residue at the 25th position in Framework Region 1 of the heavy chain variable region (FR-H1) is a proline residue. Paragraph [0047] of the specification discloses “’derived from’ the FR of a human immunoglobulin herein means that the amino acid sequence of each FR of the antibody of this form is homologous (preferably identical) to the amino acid sequence of the corresponding FR of the human immunoglobulin, with a homology (preferably, an identity) of typically 80% or more, particularly 85% or more, or even particularly 90% or more, and/or with the exception of a difference of typically four amino acid residues or less, particularly three amino acid residues or less, and even particularly two amino acid residues or less.” This paragraph provides examples of FR regions derived from human antibodies but does not provide a limiting definition for “heavy-chain and light-chain framework regions (FRs) each derived from a human antibody.” Instant claim 3 has been interpreted as including any humanized antibody sequence where at least one amino acid in each framework region has a corresponding human antibody amino acid in the framework region, particularly as the claim does not require any particular human antibody framework region (i.e. a specific base sequence)..
Tanokura et al. (U.S. Patent Application Publication 2022/0033485, of record) discloses humanized anti-IGF-1 receptor antibodies based on antibody IGF11-16. See at least paragraph [0167], Example 1, and claims 1-3. Pharmaceutical compositions are disclosed. See at least claim 14 of Tanokura et al. with respect to instant claim 29. Use of human framework regions is disclosed. See at least paragraphs [0129-0133]. In particular, the humanized antibody of SEQ ID NOS: 7 and 8 (VH/VL) is disclosed.
SEQ ID NO: 1, 2, 3, 4, 5, and 6 of Tanokura et al. are identical to instant SEQ ID NO: 1, 3, 7, 9, 11, and 13, respectively. Instant claim 3 includes embodiments having the CDRs of instant SEQ ID NOS: 1, 3, 7, 9, 11, and 13 with no substitutions. The humanized IGF-1R antibodies in claims 2-3 (as they depend from claim 1) of Tanokura et al. meet the limitations of instant claim 3. The VH of SEQ ID NO: 7 has a proline at amino acid position 25.
With respect to instant claim 6, at least claim 6 discloses these limitations. Instant SEQ ID NO: 71 corresponds to SEQ ID NO: 14 and contains amino acids 308-319 of the human IGF-1 receptor.
See SEQ ID NO: 7 with the VH CDRs of instant SEQ ID NOS: 1, 3, and 7 underlined below. The proline at amino acid position 25 in framework region 1 is underlined. Note that the framework regions have homology to human antibodies meeting the limitations of the claims.
QVQLVQPGAELVKPGASVKVSCKAPGYTFTSYWMHWVRQAPGQGLEWIGETNPSNSVTNYNEKFKSKATLTVDTSTSTVYMELSSLRSEDTAVYYCTIGRGRGFAYWGQGTLVTVS
See SEQ ID NO: 8 with the VL CDRs of instant SEQ ID NOS: 9, 11, and 13 underlined below. Note that the framework regions have homology to human antibodies meeting the limitations of the claims.
DIQMTQSPSSLSASVGDRVTITCRASQNINFWLSWYQQKPGKAPKLLIYKASNLHTGVPSRFSGSGSGTDFTFTISSLQPEDIATYYCLQGQSYPYTFGQGTKLEIK
With respect to instant claims 8-10, at least claims 4-5 and paragraphs [0113, 0133, and 0136] disclose these limitations. With respect instant claim 11, at least paragraph [0115] discloses this limitation. With respect to instant claims 12-13 and 19-20, at least claim 7 and paragraphs [0068, 0088-0090, 0118, 0135-0145, 0155-0156] disclose the limitations of these claims. With respect to instant claim 15, at least paragraphs [0139-0141 and 0205-0211] disclose these limitations. With respect to instant claim 17, at least claim 8 discloses these limitations. With respect to instant claim 18, at least claim 9 discloses these limitations.
With respect to instant claim 14, the properties recited in this claim are considered to be inherent to the antibodies of Tanokura et al. based on the binding information disclosed. Tanokura et al. does not disclose testing with a BIACORE binding assay.
The antibodies of Tanokura et al. meet the structural limitations of instant claim 3. As such, the properties of claims 16 and 21-24 are considered to be inherent to the antibodies of Tanokura et al. See in addition paragraphs [0146 and 0175]. Tanokura et al. does not disclose inducing hypophysectomized model animals, proliferation induced by IGF-1 receptor activating ligands, cancer cell proliferation assays, or cancer-bearing model animals.
Applicant is reminded that the instant claims are directed to products and not methods of using products. Should applicant provide argument or evidence that the properties recited in the claims are not inherent to the antibodies of Tanokura, this will be viewed as an admission that the scope of the claims is not enabled. In addition, applicant should point out those structural features responsible for providing each of the different biological effects recited in the claims.
The claimed anti-IGF-1 receptor humanized antibodies are anticipated.
Claims 3, 6, 8-24, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eguchi et al. (WO 2018/221521, of record) and Eguchi et al. (U.S. Patent Application Publication 2020/0115460, of record) and are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Eguchi et al. (WO 2018/221521, of record), Eguchi et al. (U.S. Patent Application Publication 2022/0115460, of record), and Eguchi et al. (U.S. Patent No. 11,629,194).
All of the references remain valid prior art for the reasons set forth in the prior Office action. The effective filing date of the instant application is 1 June 2021. Applicant cannot rely upon the certified copy of the foreign priority application JP 2020-096344 because a translation of said application has not been made of record in accordance with 37 CFR 1.55 as set forth in the prior Office action.
Eguchi et al. (U.S. Patent Application Publication 2020/0115460) will be referenced for the reasons set forth in the prior Office action.
Independent claim 3 as amended requires heavy-chain and light-chain framework regions (FR) derived from a human antibody and wherein the amino acid residue at the 25th position in Framework Region 1 of the heavy chain variable region (FR-H1) is a proline residue. Paragraph [0047] of the specification discloses “’derived from’ the FR of a human immunoglobulin herein means that the amino acid sequence of each FR of the antibody of this form is homologous (preferably identical) to the amino acid sequence of the corresponding FR of the human immunoglobulin, with a homology (preferably, an identity) of typically 80% or more, particularly 85% or more, or even particularly 90% or more, and/or with the exception of a difference of typically four amino acid residues or less, particularly three amino acid residues or less, and even particularly two amino acid residues or less.” This paragraph provides examples of FR regions derived from human antibodies but does not provide a limiting definition for “heavy-chain and light-chain framework regions (FRs) each derived from a human antibody.” Instant claim 3 has been interpreted as including any humanized antibody sequence where at least one amino acid in each framework region has a corresponding human antibody amino acid in the framework region, particularly as the claim does not require any particular human antibody framework region (i.e. a specific base sequence)..
SEQ ID NO: 3, 4, 5, 6, 7, and 8 of Eguchi et al. are identical to instant SEQ ID NO: 1, 3, 7, 9, 11, and 13, respectively. Instant claim 3 includes embodiments having the CDRs of instant SEQ ID NOS: 1, 3, 7, 9, 11, and 13 with no substitutions.
The humanized IGF-1R antibodies in claim 24 (as it depends from claim 1). Claim 26 (as it depends from claim 1) recites the VH of SEQ ID NO: 9 and the VL of SEQ ID NO: 10. The VH of SEQ ID NO: 9 has a proline at amino acid position 25. The antibodies of Eguchi et al. meet the limitations of instant claim 3.
See SEQ ID NO: 9 with the VH CDRs of instant SEQ ID NOS: 1, 3, and 7 underlined below. The proline at amino acid position 25 in framework region 1 is underlined. Note that the framework regions have homology to human antibodies meeting the limitations of the claims.
QIQLQQPGAELVKPGASVKLSCKAPGYTFTSYWMHWVKQRPGQGLEWIGETNPSNSVTNYNEKSKATLTVDKSSSTAYMQLSSLTSEDSAVYYCTIGRGRGFAYWGQGTLVTVSA
See SEQ ID NO: 10 with the VL CDRs of instant SEQ ID NOS: 9, 11, and 13 underlined below. Note that the framework regions have homology to human antibodies meeting the limitations of the claims.
DIQMNQSPSSLSASLGDTITITCRASQNINFWLSWCQQKPGNIPKLLIYKASNLHTGVPSRFSGSGSGTDFTLTISSLQPEDIATYYCLQGQSYPYTFGGGTKLEIK
With respect to instant claim 6, at least claims 17-18 discloses these limitations. SEQ ID NO: 32 in claim 18 corresponds to amino acids 308-319 of instant SEQ ID NO: 71.
With respect to instant claims 8-10, at least claims 25-26 and paragraph [0143] disclose these limitations.
With respect instant claim 11, at least claim 11 and paragraphs [0077 and 0144] disclose this limitation.
With respect to claim 29, pharmaceutical compositions are disclosed. See at least claim 33.
With respect to instant claims 12-24, see at least claims 7-14, 16-17 and 21-22 and paragraph [0077, 0097-0098, 0116-0118]. The antibodies of Eguchi et al. meet the structural limitations of instant claim 3. As such, the properties of claims 12-24 are considered to be inherent to the antibodies of Eguchi et al. where the disclosure in Eguchi et al. does not use the identical language as in the instant claims. Applicant is reminded that the instant claims are directed to products and not methods of using products. Should applicant provide argument or evidence that the properties recited in the claims are not inherent to the antibodies of Eguchi et al., this will be viewed as an admission that the scope of the claims is not enabled. In addition, applicant should point out those structural features responsible for providing each of the different biological effects recited in the claims.
The claimed anti-IGF-1 receptor humanized antibodies are anticipated.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3, 6-24, and 29 are 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.
Claim 3 has been amended and is now an independent claim. The antibodies of the claims no longer require that at least one of the CDRs contains s substitution of at least one amino acid residue relative to the corresponding CDR of the mouse parent antibody IGF11-16 (i.e. the CDRs instant SEQ ID NO: 85-90, equivalent to instant SEQ ID NOS: 1, 3, 7, 9, 11, and 13, respectively) as recited in instant claim 1 (now cancelled). Claim 3 as originally presented depended upon claim 1. No basis was provided for the claim amendments and none is apparent.
Claim 3 has also been amended to recite “a sequence of CDR-2 of the heavy chain variable region (CDR-H2), amino acide sequence defined in SEQ ID NO:3 or SEQ ID NO:5, or amino acid sequence derived from SEQ ID NO:3 in which Asn at the 6th position of SEQ ID NO:3 is substituted wither or Gln.” No basis was provided for this limitation and none is apparent, particularly in conjunction with the sequences in dependent claim 7 and the properties of dependent claims 6 and 11-24. Note that the antibodies of dependent claim 7 would be required to retain the CDRs of claim 3 for proper dependency.
Claim 3 has also been amended to recite “a sequence of CDR-2 of the light chain variable region (CDR-L2), amino acid sequence defined in SEQ ID NO:11, or an amino acid sequence derived from SEQ ID NO:11 in which Leu at the 5th position of SEQ ID NO:11 is substituted wither or Arg.” No basis was provided for this limitation and none is apparent, particularly in conjunction with the sequences in dependent claim 7 and the properties of dependent claims 6 and 11-24. Note that the antibodies of dependent claim 7 would be required to retain the CDRs of claim 3 for proper dependency.
No basis is seen for the claims. The claims constitute new matter.
Claims 12-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the specifically exemplified antibodies in the examples, does not reasonably provide enablement for all antibodies encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The genus of antibodies claimed lacks written description for the reasons set forth above. Because the structures of the antibodies having the claimed properties are not adequately described, the scope of the claims is not enabled. It would constitute undue experimentation to determine which antibodies encompassed by claim 1 but not exemplified or tested in the specification examples would have the properties recited in claims 12-24.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)) the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation." These factors include: (a) the quantity of experimentation necessary; (b) the amount of direction or guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the relative skill of those in the art; (g) the predictability of the art; and (h) the breadth of the claims.
In the instant application the breadth of the claims is large with respect to the antibodies encompassed and multiple functional activities are required by the antibodies. Note that claims encompass any normal mammal (claim 15), any hypophysectomized model animal (claim 16), any vertebrate animal (claim 17-18), any cancer-bearing model animal (claims 23-24), any cancer cell (claim 21-22), and any cell proliferative disorder (claim 22). There is no guidance or direction with respect to the structure of those antibodies having the recited functions. A large amount of experimentation would be required to determine those antibodies within the scope of the claims that have the recited functions. The examples in the specification are not commensurate in scope to the claims and their results could not be extrapolated to other antibodies within the scope of the claims.
It would constitute undue experimentation to determine those antibodies within the scope of the claims having the recited properties.
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 3, 6-24, and 29 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 3 is confusing in reciting “Asn at the 6th position of SEQ ID NO: 3 is substituted wither or Gln” and “Leu at the 5th position of SEQ ID NO: 11 is substituted wither or Arg.” It is not known what was intended. The metes and bounds of the claims cannot be determined.
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 29 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 pharmaceutical composition of claim 29 requires nothing more than the product of instant claim 3. 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.
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.
Claims 3, 6, 8-24, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 28-44, of U.S. Patent No.11,629,194. Although the claims at issue are not identical, they are not patentably distinct from each other.
Issued claim 1 is directed an anti-IGF-1 receptor antibody that can induce growth of vertebrate-derived cells (i.e. the activation of instant claim 12). The antibody has the CDRs of SEQ ID NO: 3, 4, 5, 6, 7, and 8 (identical to instant SEQ ID NO: 1, 3, 7, 9, 11, and 13, respectively). Issued claim 44 is directed to an anti-IGF-1 receptor antibody of claim 1 having a VH of SEQ ID NO: 9 and a VL of SEQ ID NO: 10. The VH of SEQ ID NO: 9 has a proline at amino acid position 25. The antibodies of the ‘194 patent meet the limitations of instant claim 3.
Instant claim 3 includes embodiments having the CDRs of instant SEQ ID NOS: 1, 3, 7, 9, 11, and 13 with no substitutions.
See SEQ ID NO: 9 with the VH CDRs of instant SEQ ID NOS: 1, 3, and 7 underlined below. The proline at amino acid position 25 in framework region 1 is underlined. Note that the framework regions have homology to human antibodies meeting the limitations of the claims.
QIQLQQPGAELVKPGASVKLSCKAPGYTFTSYWMHWVKQRPGQGLEWIGETNPSNSVTNYNEKSKATLTVDKSSSTAYMQLSSLTSEDSAVYYCTIGRGRGFAYWGQGTLVTVSA
See SEQ ID NO: 10 with the VL CDRs of instant SEQ ID NOS: 9, 11, and 13 underlined below. Note that the framework regions have homology to human antibodies meeting the limitations of the claims.
DIQMNQSPSSLSASLGDTITITCRASQNINFWLSWCQQKPGNIPKLLIYKASNLHTGVPSRFSGSGSGTDFTLTISSLQPEDIATYYCLQGQSYPYTFGGGTKLEIK
Issued claims 14-15 are directed to the binding of instant claim 6. SEQ ID NO: 32 corresponds to amino acids 308-319 of instant SEQ ID NO: 71. Issued claim 12 discloses the limitations of instant claim 18. Issued claim 17 recites the limitations of instant claim 17. Issued claim 18 discloses the inhibition of instant claims 19 and 22. Issued claim 23 discloses constant regions from humans (i.e. any class of human immunoglobulin). See instant claim 8. Issued claim 31 is directed to the pharmaceutical compositions of instant claim 29. Issued claim 39 is considered to meet the limitations of instant claim 13.
Absent evidence to the contrary, the properties recited by instant claims 12, 14-16, 20-21, and 24 would be inherent to the antibodies of the ‘194 patent. The antibodies of the ‘194 patent meet the structural limitations of instant claim 3. As such, the properties of claims 12, 14-16, 20-21, and 24 are considered to be inherent to the antibodies of the ‘194 patent. Applicant is reminded that the instant claims are directed to products and not methods of using products. Should applicant provide argument or evidence that the properties recited in the issued claims are not inherent to these antibodies, this will be viewed as an admission that the scope of the claims is not enabled. In addition, applicant should point out those structural features responsible for providing each of the different biological effects recited in the claims.
The issued claims and the instant claims are not patentably distinct.
Claims 3, 6, 8-24, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, of U.S. Patent No.12,227,563. Although the claims at issue are not identical, they are not patentably distinct from each other.
Issued claim 1 is directed to an anti-IGF-I receptor humanized antibody having a VH of SEQ ID NO: 7 and a VL of SEQ ID NO: 8.
SEQ ID NO: 7 of the ‘563 patent contains the CDRs of instant SEQ ID NOS: 1, 3, and 7.
SEQ ID NO: 8 of the ‘563 patent contains the CDRs of instant SEQ ID NOS: 9, 11, and 13. Instant claim 3 includes embodiments having the CDRs of instant SEQ ID NOS: 1, 3, 7, 9, 11, and 13 with no substitutions. The VH of SEQ ID NO: 7 has a proline at amino acid position 25.
See SEQ ID NO: 7 with the VH CDRs of instant SEQ ID NOS: 1, 3, and 7 underlined below. The proline at amino acid position 25 in framework region 1 is underlined. Note that the framework regions have homology to human antibodies meeting the limitations of the claims.
QVQLVQPGAELVKPGASVKVSCKAPGYTFTSYWMHWVRQAPGQGLEWIGETNPSNSVTNYNEKFKSKATLTVDTSTSTVYMELSSLRSEDTAVYYCTIGRGRGFAYWGQGTLVTVS
See SEQ ID NO: 8 with the VL CDRs of instant SEQ ID NOS: 9, 11, and 13 underlined below. Note that the framework regions have homology to human antibodies meeting the limitations of the claims.
DIQMTQSPSSLSASVGDRVTITCRASQNINFWLSWYQQKPGKAPKLLIYKASNLHTGVPSRFSGSGSGTDFTFTISSLQPEDIATYYCLQGQSYPYTFGQGTKLEIK
Issued claims 2-3 disclose the limitation of instant claims 8-10.
Issued claim 4 discloses the limitations of instant claim 29.
Absent evidence to the contrary, the properties recited by instant claims 6 and 11-24 would be inherent to the antibodies of the ‘563 patent. The antibodies of the ‘563 patent meet the structural limitations of instant claim 3. As such, the properties of claims 6 and 11-24 are considered to be inherent to the antibodies of the ‘563 patent. Applicant is reminded that the instant claims are directed to products and not methods of using products. Should applicant provide argument or evidence that the properties recited in the issued claims are not inherent to these antibodies, this will be viewed as an admission that the scope of the claims is not enabled. In addition, applicant should point out those structural features responsible for providing each of the different biological effects recited in the claims.
The issued claims and the instant claims are not patentably distinct.
As set forth in the prior Office action, the VH amino acid sequences of instant SEQ ID NOS: 43, 47, 49, 53, 55, and 59 are free of the prior art. SEQ ID NOS: 47, 53, and 59 contain the CDRs of instant SEQ ID NOS: 1, 5, and 7. SEQ ID NOS: 43, 49, and 55 have the CDR of SEQ ID NO: 5 where the sixth amino acid is Asn (N) not Ser (S). SEQ ID NOS: 43, 49, and 55 have the CDRs of SEQ ID NOS: 1 and 7.
The VL amino acid sequences of instant SEQ ID NOS: 65, 67, and 69 are free of the prior art. SEQ ID NOS: 65 and 67 have the CDRs of SEQ ID NOS: 9, 11, and 13. SEQ ID NO: 69 has the CDRs of SEQ ID NOS: 9 and 13. The LCDR2 sequence of SEQ ID NO: 69 has a substitution of L for R at the fifth amino acid position of SEQ ID NO: 11.
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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