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 .
Formal Matters
In Remarks (09/23/2025), Applicant indicated that if the instant case could not be allowed, to contact Applicant’s representative. It is of the Examiner’s opinion that the instant Office Action is meaningful in facilitating any conversation necessary to move the instant application to allowance. After review of the instant Office Action, Applicant in invited to contact the Examiner regarding, specifically, the outstanding double patenting rejection(s).
Claim Status
Claims 1-65, 70, 72-73, and 75 have been cancelled; claims 66-67, 69, 71, 74, and 76 have been amended; and, claims 77-83 have been newly added, as requested in the amendment filed on September 23, 2025. Following the amendment, claims 66-69, 71, 74, and 76-83 are pending in the instant application.
Claim 67-68 stand as withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species of invention in the Response filed May 28, 2025, there being no allowable generic or linking claim.
Claims 66, 69, 71, 74, and 76-83 are under examination in the instant office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 66, 68-69, 71, 74, and 76-83 have an effective filing date of December 28, 2022 corresponding to PCT/CN2022/142620, as the claim to foreign priority has been perfected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/07/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings - Objection Withdrawn
Applicant has amended the figure label for Figure 2. As such, the objection to the drawings is withdrawn.
Specification - Objection Withdrawn
Applicant has amended the specification to delete the embedded hyperlink/other form of browser executable code on Page 197. As such, the objection to the specification is withdrawn.
Claim Objections - Withdrawn
With regard to the objection to claims 52, 63, and 65 for the recitation of “0 or no less than 1” with regard to the replacement of methylene units, it is noted that claims 52, 63, and 65 have been cancelled rendering the objection moot. As such, the objection to claims 52, 63, and 65 is withdrawn.
With regard to the objection to claims 52 and 71 for the inclusion of additional periods, claim 52 has been cancelled, rendering the objection moot, and claim 71 has been amended to remove the additional periods. As such, the objection to claims 52 and 71 is withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn
With regard to the rejection of claim 71 under 35 U.S.C. § 112(b) as being indefinite for the recitation of “the compound” which lacked antecedent basis, it is noted that claim 71 has been cancelled rendering the rejection moot. As such, the rejection of claim 71 under 35 U.S.C. § 112(b) is withdrawn.
Claim Rejections - 35 USC § 103 - Withdrawn
Claim(s) 52-60, 63-66, 69-71, 74, and 76 were rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/068878 A1 (Foreign Reference Citation #3 on 03/03/2025 IDS; Espacenet Translation Utilized; herein after referred to as "Zhang") in view of WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claim(s) 52-54, 63-65, 71, 74, and 76 were rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/236136 A1 (previously cited on PTO-892; herein after referred to as "Strop") in view of WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claim(s) 55-60, 66, and 69-70 were rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/236136 A1 (previously cited on PTO-892; herein after referred to as "Strop") in view of WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen"), as applied to claims 52-54, 63-65, 71, 74, and 76 above, and in further view of non-patent literature by Schӧnherr and Cernak (Angew. Chem. Int. Ed., 2013, 52, 12256-12267; previously cited on PTO-892; herein after referred to as “Cernak”).
With regard to the above-listed claim rejections, it is noted that on Pages 14-15 of Remarks (09/23/2025) Applicant argues that in the Nielsen reference does not qualify as prior art under 35 U.S.C. 102(b)(1)(A) in view of the claim to foreign priority and the common inventors Christoffer Nielsen, Niels Behrendt, and Lars Henning Engelholm; the subject matter of the cited Nielsen reference was obtained directly from the inventors of the instant application less than one year prior to the instant application’s earliest claimed priority date. Applicant further argues that the Nielsen reference does not qualify as prior art under 35 U.S.C. 102(b)(2)(A) because the subject matter of the cited Nielsen reference was obtained directly from the inventors of the instant application. Applicant also argues that the remaining references (Zhang, Strop, and Cernak) fail to render obvious the instant claims. In view of the claim to foreign priority being perfected and inventorship being updated for the instant application, Applicant’s arguments are deemed persuasive and the above-listed claim rejections under 35 U.S.C. 103 are withdrawn.
Double Patenting - Withdrawn
Claims 52-60, 63-66, 69-71, 74, and 76 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-12, and 22-25 of U.S. Patent No. 12,138,316 (herein after referred to as "reference patent") in view of WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claims 52-60, 63-66, 69-71, 74, and 76 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of copending Application Nos. 18/900,491, 18/872,244, 18/844,409, and 18/833,846 in view of WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claims 52-60, 63-66, 69-71, 74, and 76 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,940,213 (herein after referred to as “second reference patent”) in view of WO 2022/068878 A1 (Foreign Reference Citation #3 on 03/03/2025 IDS; Espacenet Translation Utilized; herein after referred to as "Zhang") and WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claims 52-54, 63-65, 71, 74, and 76 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,940,213 (herein after referred to as “second reference patent”) in view of WO 2022/236136 A1 (previously cited on PTO-892; herein after referred to as "Strop") and WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claims 55-60, 66, and 69-70 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,940,213 (herein after referred to as “second reference patent”) in view of WO 2022/236136 A1 (previously cited on PTO-892; herein after referred to as "Strop") and WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen"), as applied to claims 52-54, 63-65, 71, 74, and 76 above, and in further view of non-patent literature by Schӧnherr and Cernak (Angew. Chem. Int. Ed., 2013, 52, 12256-12267; previously cited on PTO-892; herein after referred to as “Cernak”).
Claims 52-60, 63-66, 69-71, 74, and 76 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,819,552 (herein after referred to as “third reference patent”) in view of WO 2022/068878 A1 (Foreign Reference Citation #3 on 03/03/2025 IDS; Espacenet Translation Utilized; herein after referred to as "Zhang") and WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claims 52-54, 63-65, 71, 74, and 76 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,819,552 (herein after referred to as “third reference patent”) in view of WO 2022/236136 A1 (previously cited on PTO-892; herein after referred to as "Strop") and WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claims 55-60, 66, and 69-70 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,819,552 (herein after referred to as “third reference patent”) in view of WO 2022/236136 A1 (previously cited on PTO-892; herein after referred to as "Strop") and WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen"), as applied to claims 52-54, 63-65, 71, 74, and 76 above, and in further view of non-patent literature by Schӧnherr and Cernak (Angew. Chem. Int. Ed., 2013, 52, 12256-12267; previously cited on PTO-892; herein after referred to as “Cernak”).
Claims 52-60, 63-66, 69-71, 74, and 76 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of copending Application No. 18/485,460 in view of WO 2022/068878 A1 (Foreign Reference Citation #3 on 03/03/2025 IDS; Espacenet Translation Utilized; herein after referred to as "Zhang") and WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claims 52-54, 63-65, 71, 74, and 76 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of copending Application No. 18/485,460 in view of WO 2022/236136 A1 (herein after referred to as "Strop") and WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen").
Claims 55-60, 66, and 69-70 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of copending Application Nos. 18/485,460 in view of WO 2022/236136 A1 (previously cited on PTO-892; herein after referred to as "Strop") and WO 2023/275112 A1 (Foreign Reference Citation #4 on 03/03/2025 IDS; herein after referred to as "Nielsen"), as applied to claims 52-54, 63-65, 71, 74, and 76 above, and in further view of non-patent literature by Schӧnherr and Cernak (Angew. Chem. Int. Ed., 2013, 52, 12256-12267; previously cited on PTO-892; herein after referred to as “Cernak”).
With regard to the above-listed claim rejections under nonstatutory double patenting, it is noted that in view of the instant claim amendments and the disqualification of Nielsen as prior art under 35 U.S.C. 102(b)(1)(A) and 35 U.S.C. 102(b)(2)(A), the above-listed claim rejections under nonstatutory double patenting are withdrawn.
Double Patenting - Updated
Claims 66, 69, 71, 74, and 76-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-8, 20, 23-27, 60, and 63 of 18/565,621 (herein after referred to as “reference application”) in view of WO 2022/068878 A1 (Foreign Reference Citation #3 on 03/03/2025 IDS; Espacenet Translation Utilized; herein after referred to as "Zhang").
The reference application is generally drawn to uPARAP antibodies and antibody-drug conjugates (ADCs), pharmaceutical compositions, and kits thereof. Reference application claim 1 discloses a uPARAP antibody that comprises a light chain variable region and heavy chain variable region comprising or consisting of the sequences of SEQ ID NOs: 3 and 6, respectively. It is noted that reference application SEQ ID NOs: 3 and 6 are 100% identical to instant SEQ ID NOs: 3 and 6, respectively. Reference application claim 2 discloses that the antibody of claim 1 may further comprise a light chain and heavy chain comprising or consisting of the sequences of SEQ ID NOs: 1 and 4, respectively. It is noted that reference application SEQ ID NOs: 1 and 4 are 100% identical to instant SEQ ID NOs: 1 and 4, respectively. Reference application claim 4 discloses an ADC comprising the antibody of claim 1, an active agent, and a linker that links the antibody to the active agent. Claims 5, 7-8, and 20 further disclose possible active agents, including exatecan derivatives. Reference application claim 23 discloses the drug-to-antibody ratio (DAR) of the ADC is between 1 and 10. Reference application claims 24-27 further detail features of the ADC regarding linkers, spacers, and attachment groups. Reference application claim 60 is drawn to a pharmaceutical composition comprising the ADC of claim 4, and claim 63 is drawn to a kit comprising the ADC of claim 4. Thus, the reference application teaches a uPARAP antibody comprising the instantly claimed sequences, a generic ADC thereof, and a pharmaceutical composition and kit comprising said ADC. However, it is noted that no specific ADC structure (e.g., that of instant formula D-III-7) is provided by the reference application. This deficiency is remedied by Zhang.
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With regard to instant claims 66, and 78-80, Zhang discloses a compound or a tautomer, meso, racemate, enantiomer, diastereomer, or mixture thereof, or a pharmaceutically acceptable form thereof, comprising the structure shown in formula (III-C) below (Page 10):
Zhang further discloses a compound (i.e., an antibody-drug conjugate/ADC) or a tautomer, meso, racemate, enantiomer, diastereomer, or mixture thereof, or a pharmaceutically acceptable form thereof, comprising the structure shown in formula (III-D) below, wherein Ab is a ligand, and the average number of connections Na is an integer or decimal from 1 to 10 (Page 12):
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Zhang also discloses specific embodiments of ADCs (ADC-III-9 through ADC-III-12, including tautomers, mesomers, racemates, enantiomers, diastereomers, or mixtures thereof, or pharmaceutically acceptable forms thereof.) all of which comprise the formula shown below attached to different antibodies (Pages 150-151):
Thus, Zhang teaches an ADC comprising a linker/active agent according to instant formula D-III-7. Zhang teaches some exemplary antibodies for use in the ADCs of the invention include Trastuzumab, Pertuzumab, Sacituzumab, and/or Zolbetuximab as used in ADC-III-9 through ADC-III-12, respectively (Page 150-151). Zhang also discloses the use of compounds of the invention in the preparations of medicaments for treating tumors, pharmaceutical compositions comprising said compounds for use in the treatment of tumors, and/or administering said compounds to a subject in need thereof for the treatment of tumors (Pages 161-162).
The reference application and Zhang are considered to be analogous to the present invention as they are in the same field of ADCs. Thus, it would have been obvious to one of ordinary skill in the art to modify the ADC taught by Zhang such that the drug-linker compound taught by Zhang is linked to a uPARAP antibody as disclosed by the reference application because combining prior art elements according to known methods would be expected to yield predictable results. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). The ADCs of both Zhang and the reference application can be used in the treatment of cancers, and while the reference application does not teach a specific structure for ADCs of the invention, the reference application does generally suggest an ADC comprising an attachment group, linker components, spacers, and a drug exemplified by Zhang.
With regard to claim 69, Zhang discloses that compounds of the invention include, but are not limited to, formula P-III-20 shown below:
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One of ordinary skill in the art would recognize that the active agent in ADCs of the invention can be derived from formula P-III-20 (Page 135), which would correspond to instant formulas P-III-30 and P-III-31, wherein the -OH group is the reactive group linking the active agent and linker to become R1 in both the instantly claimed ADC structures and those of Zhang above. It is further noted that Zhang teaches compounds of the invention can include a tautomer, mesomer, racemate, enantiomer, diastereomer, or mixture thereof, or a pharmaceutically acceptable form thereof (see, for example, Page 10), and thus one of ordinary skill in the art would recognize that a tautomer, mesomer, racemate, enantiomer, diastereomer, or mixture thereof, or a pharmaceutically acceptable form of P-III-20 is also suggested by Zhang. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention as evidenced by the references.
With regard to claim 70, Zhang discloses that compounds of the invention include, but are not limited to, formula L-III-20 (i.e., a drug-linker compound; Page 144) shown below:
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It is further noted that Zhang teaches compounds of the invention can include a tautomer, mesomer, racemate, enantiomer, diastereomer, or mixture thereof, or a pharmaceutically acceptable form thereof (see, for example, Page 10), and thus one of ordinary skill in the art would recognize that a tautomer, mesomer, racemate, enantiomer, diastereomer, or mixture thereof, or a pharmaceutically acceptable form of L-III-20 is also suggested by Zhang. Thus, Zhang teaches/suggests instantly claimed formula L-III-31, which corresponds to the elected species. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention as evidenced by the references.
With regard to claims 71 and 81-83, it is further noted that the reference application teaches that the antibody of claim 1 may further comprise an immunoglobulin light chain comprising or consisting of the amino acid sequence of SEQ ID NO: 1 and an immunoglobulin heavy chain comprising or consisting of the amino acid sequence of SEQ ID NO: 4 (see claim 2). Reference application SEQ ID NOs: 1 and 4 are a 100% match to instant SEQ ID NOs: 1 and 4, respectively. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention as evidenced by the references.
With regard to claim 74, Zhang teaches that the invention also provides a pharmaceutical composition comprising the compound of the invention or its tautomer, meso, racemate, enantiomer, diastereomer, or a mixture thereof, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier (Page 16). The reference application also teaches a pharmaceutical composition comprising the ADC of claim 4, and a pharmaceutically acceptable buffer, diluent, carrier, adjuvant or excipient (see claim 60). Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention as evidenced by the references.
With regard to claim 76, the reference application further teaches a kit comprising the ADC of claim 4 (see claim 63). It is well-settled law that combining printed instructions and an old product into a kit will not render the claimed invention non-obvious even if the instructions detail a new use for the product. See In re Negai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1862 (Fed. Cir. 2004). Further, the inclusion of a package insert or label showing "the name of drug, dosage form, route of administration, indication and direction of use" of a pharmaceutical composition is mandated by 21 CFR 201.57 and is therefore obvious to one of ordinary skill in the art. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention as evidenced by the references.
With regard to claim 77, the reference application teaches that the ADC of claim 4 has a drug-to-antibody ratio (DAR) between 1 and 10. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention as evidenced by the references.
This is a provisional nonstatutory double patenting rejection.
Claims 66, 68-70, 71, 74, and 76-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-8, 20, 23-27, 60, and 63 of 18/565,621 (herein after referred to as “reference application”) in view of WO 2022/236136 A1 (previously cited on PTO-892; herein after referred to as "Strop"), as applied to claims 52-54, 63-65, 71, 74, and 76 above, and in further view of non-patent literature by Schӧnherr and Cernak (Angew. Chem. Int. Ed., 2013, 52, 12256-12267; previously cited on PTO-892; herein after referred to as “Cernak”).
The pertinent disclosures of the claims of the reference application are detailed above. However, the reference application does not disclose a specific ADC structure (e.g., that of instant formula D-III-7). This deficiency is remedied by Strop and Cernak.
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With regard to claims 66 and 78-80, Strop teaches compounds of formula (I), shown below, which are exatecan derivatives with novel chemical linkers that include cathepsin B cleavable moieties, and conjugated to targeting antibodies (Abstract).
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Strop further teaches that -N(Y)-Z-R of formula (I) may be the group shown below (Page 17).
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Thus, when X is O for formula (I), as defined at Page 15, then the structure is that of compound 3 (Page 25; Table 1) as shown below.
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Strop further teaches a drug conjugate represented by the formula shown below, wherein: (i) X is O or S; (ii) A is NH or triazolyl; (iii) Lig is a targeting moiety; (iv) L1 is a linker moiety; and (v) RR is an alkoxy or amino moiety formed from L1 and a hydroxy or -NH2 moiety of R of any therapeutic payload described by the invention (e.g., compound 3) (Page 60).
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In some embodiments, Lig is a monoclonal antibody and can be an antibody selected, for example, from the group consisting of: an anti-TROP2 antibody, an anti-EGRF antibody, an anti-HER2 antibody, an anti-B7-H3 antibody, an anti-CD30 antibody, an anti-CD33 antibody, and an anti-CD70 antibody (Page 60). Strop further teaches that L1 can be represented by the structure shown below (Page 61).
However, it is noted that Strop does not teach an -N(Y)-Z-R group further comprising a methyl group as required by instant formula D-III-7. This deficiency is remedied by Cernak.
Cernak teaches that small improvements in binding affinity observed upon introducing a methyl group have been attributed to desolvation effects and increased methylation reduces the free energy of desolvation required to strip a ligand of solvated water molecules when it transfers from an aqueous environment to the greasy cavity of a protein; in this way, methylation can energetically favor binding and lower the IC50 value (Page 12257, Column 2, The Magic Methyl Effect). Estimates place the value for ΔΔGtransfer upon a proton for methyl replacement at about 0.8 kcalmol-1 for transfer from water to a protein, which corresponds to an approximate 3.5-fold boost in potency from methylation based on ΔΔGtransfer alone; a more empirical evaluation of literature examples by Jorgensen and co-workers suggested that a single methyl group might boost potency approximately 10-fold, and 43-fold in an extreme example, if the new methyl group sits nicely in a hydrophobic pocket of the active site (Id.).
The reference application, Strop, and Cernak are considered to be analogous to the present invention as they are in the same field of ADCs and/or drug discovery. Thus, it would have been obvious to modify the ADC of Strop such that the antibody is the uPARAP antibody of the reference application and such that the active agent/drug component comprises a methyl group as required by instant formula D-III-7 (i.e., a methyl group comprised within the -N(Y)-Z-R group of Strop), which absent unexpected results would have been obvious if the desire was to enhance the drugs' effectiveness, as suggested by Cernak. Such a modification would render obvious a structure corresponding to formula D-III-7.
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With regard to claim 69, it is noted that Strop teaches compounds of formula (I), shown below, which are exatecan derivatives with novel chemical linkers that include cathepsin B cleavable moieties, and conjugated to targeting antibodies (Abstract).
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Strop further teaches that -N(Y)-Z-R of formula (I) may be the group shown below (Page 17).
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Thus, when X is O for formula (I), as defined at Page 15, then the structure is that of compound 3 (Page 25; Table 1) as shown below.
As detailed above with regard to claims 66 and 78-80, substitution of a hydrogen for a methyl group or vice versa is obvious in medicinal chemistry (i.e., the magic methyl effect), as disclosed by Cernak. Thus, it would have been obvious to modify an ADC rendered obvious by Strop and the reference application such that the active agent/drug component comprises a methyl group in the -N(Y)-Z-R group of Strop, which absent unexpected results would have been obvious if the desire was to enhance the drugs' effectiveness, as suggested by Cernak. Such a modification would render obvious the structure corresponding to formula P-III-31 of claim 69.
With regard to claims 71 and 81-83, it is further noted that the reference application teaches that the antibody of claim 1 may further comprise an immunoglobulin light chain comprising or consisting of the amino acid sequence of SEQ ID NO: 1 and an immunoglobulin heavy chain comprising or consisting of the amino acid sequence of SEQ ID NO: 4 (see claim 2). Reference application SEQ ID NOs: 1 and 4 are a 100% match to instant SEQ ID NOs: 1 and 4, respectively. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention as evidenced by the references.
With regard to claims 74 and 76, Strop further teaches a pharmaceutical composition comprising (i) a therapeutic payload, (ii) a linker-payload construct, or (iii) a drug conjugate of the invention and a pharmaceutically acceptable excipient; exemplary pharmaceutical compositions may be used in the form of a pharmaceutical preparation, for example, in solid, semisolid or liquid form, which contains one or more disclosed compounds, as an active ingredient, in admixture with an organic or inorganic carrier or excipient suitable for external, enteral or parenteral applications (Paragraphs 00120-00121). The invention also provides kits for use by, e.g., a consumer in need of treatment of cancer, wherein such kits include a suitable dosage form of the compounds/pharmaceutical compositions of the invention and instructions describing the method of using such dosage form (Paragraph 00135). It is well-settled law that combining printed instructions and an old product into a kit will not render the claimed invention non-obvious even if the instructions detail a new use for the product. See In re Negai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1862 (Fed. Cir. 2004). Further, the inclusion of a package insert or label showing "the name of drug, dosage form, route of administration, indication and direction of use" of a pharmaceutical composition is mandated by 21 CFR 201.57 and is therefore obvious to one of ordinary skill in the art. The reference application also teaches a pharmaceutical composition comprising the ADC of claim 4, and a pharmaceutically acceptable buffer, diluent, carrier, adjuvant or excipient (see claim 60) as well as a kit comprising the ADC of claim 4 (see claim 63). Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention as evidenced by the references.
With regard to claim 77, the reference application teaches that the ADC of claim 4 has a drug-to-antibody ratio (DAR) between 1 and 10. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention as evidenced by the references.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 66-69, 71, 74, and 76-83 are pending. Claims 67-68 are withdrawn. Claims 66, 69, 71, 74, and 76-83 are rejected. 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.
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 ALYSSA RAE STONEBRAKER whose telephone number is (571)270-0863. The examiner can normally be reached Monday-Thursday 7:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA RAE STONEBRAKER/Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642