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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 July, 2025 has been entered.
Information Disclosure Statement
The information disclosure statement filed 29 July, 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Election/Restrictions
Applicants elected compound 2 of example 2 to treat diffuse large B cell lymphoma without traverse in the reply filed on 7 Nov, 2023.
Claims Status
Claims 80-83 are pending.
Claims 80 and 81 have been amended.
Claims 82 and 83 are new.
Withdrawn Objections
The objection to the claims due to duplicates is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
first rejection
Claim(s) 80-83 are rejected under 35 U.S.C. 103 as being unpatentable over Marshall et al (US 20210009719, cited by applicants) in view of Sehn et al (J. Clin. Oncol. (2019) 38(2) p155-176), with evidentiary support from Akaiwa et al (Chem. Pharm. Bull. (March 2020) 68(3) 201-211).
Marshall et al discuss peptide conjugates of cytotoxins for treating cancer (title and abstract). The structure of the peptide conjugates are simple; fitting the structure R8-Q-R7 (paragraph 28), where R7 is a peptide (paragraph 29), Q is a linker (paragraph 31), and R8 is a class of small molecule anticancer agents (paragraph 30). The peptide can be one that selectively delivers a payload to hypoxic cells or those in an acidic environment, with a pH less than 6 (paragraph 80). Among the peptides described as having these capabilities is SEQ ID 1, identical to SEQ ID 1 of the instant claims (paragraph 84). An example is given of a compound:
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(paragraph 175). Note that this is identical to applicant’s elected species
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save that the therapeutic is a camptothecin analog rather than MMAE. This compound is claimed (claim 49), and was synthesized by the authors of the paper (example 15, starts at paragraph 523), showing that the authors are clearly interested in this compound, that it appropriate as a lead compound. Among the cancers that can be treated by the invention are various lymphomas, including DLBCL, applicant’s elected disorder to be treated (paragraph 248). Pharmaceutically acceptable compositions are discussed, including pharmaceutically acceptable carriers (paragraph 275).
The difference between this reference and the instant claims is that this reference uses a different drug moiety in their construct.
Sehn et al discuss a clinical trial of polatuzumab vedotin for DLBCL (title). This is an antibody drug conjugate, with the drug being monomethyl auristatin E (p155, 2nd column, 2nd paragraph), which, as evidenced by Akaiwa et al, is the drug used in applicant’s elected species (fig 1, p202, top of page). Significantly more patients went into remission with this therapy combined with standard of care vs. standard of care alone (p163, 2nd column, 3d paragraph). This reference shows that constructs similar to that claimed by applicant, MMAE combined with a polypeptide binding agent, is effective in treating applicant’s elected disorder.
Therefore, it would be obvious to substitute the MMAE of Sehn et al for the camptothecin analogs of Marshall et al as a simple substitution of one known element (the camptothecin analogs of Marshal et al) for another (the auristatin analogs of Sehn et al) yielding expected results (tumor therapy). As Sehn et al shows a similar construct is effective in that disorder, an artisan in this field would attempt this modification with a reasonable expectation of success.
The combination of references generates a peptide of SEQ ID 1 attached to MMAE via a 1 thio 2 hydroxy cyclopentane ring, attached to the drug via a urethane bond with a nitrogen in the drug. Thus, the combination of references renders obvious claims 80 and 81.
Marshall et al discuss pharmaceutically acceptable formulations with carriers, rendering obvious claims 82 and 83.
response to applicant’s arguments
Applicants argue that the claimed compounds have unexpectedly improved activity and safety, and that the rejection does not describe a proper lead compound.
Applicant's arguments filed 29 July, 2025 have been fully considered but they are not persuasive.
Applicants argue that the claimed compounds have improved activity and safety due to the cyclopentyl ring. However, that feature is found in the compound of the primary reference. Unexpected results are compared to the closest prior art (MPEP 716.02(e)), which is presumed to be the primary reference.
Applicants argue that the rejection uses an improper lead compound analysis, that affinity is the basis of lead compounds, and, as the modified compound is not the highest affinity, it would not be selected as the lead compound. However, as has been previously noted, affinity is not the sole basis for lead compound analysis; the proper basis is any reason a person of skill in the art would reasonably modify the compound. Affinity is one rationale among many for that.
second rejection
Claim(s) 80-83 are rejected under 35 U.S.C. 103 as being unpatentable over Marshall et al (US 20190209580, cited by applicants) in view of Sehn et al (J. Clin. Oncol. (2019) 38(2) p155-176), with evidentiary support from Akaiwa et al (Chem. Pharm. Bull. (March 2020) 68(3) 201-211).
Marshall et al discuss compounds for treating diseases with acidic or hypoxic tissues (title and abstract). The structure of the peptide conjugates is simple; fitting the structure R8-Q-R7 (paragraph 11), where R8 is a pH sensitive peptide, Q is a linker, and R7 is a therapeutic molecule (paragraph 12). The peptide can be one that selectively delivers a payload to hypoxic cells or those in an acidic environment, with a pH less than 6 (paragraph 46). Among the peptides described as having these capabilities is SEQ ID 1, identical to SEQ ID 1 of the instant claims (paragraph 48). Among the linkers used in the examples is compound 1.6, with the structure:
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. This linker reads on applicant’s claims (G1 is a bond, m=2, n=0, Rs and Rt = a spiro compound or H, G2=O, OC(O)NRG or OC(O), depending on how it is linked to the therapeutic). Note that this is identical to applicant’s elected linker species if one side of the ring is moved to the methylene carbon, which is merely a shift of substituents on a core structure and not considered a patentable distinction (MPEP 2144.09 (II)). This modification is also suggested by Marshall et al, as it is allowed by the description of the linker (paragraph 29). Note that there are three examples (compounds 24, 39, and 44, out of 61 total compounds) using this linker. Given the large number of possible linkers that meet the description given by the authors, this indicates that they were very interested in this linker, making it a reasonable structure to start modifying. Among the cancers that can be treated by the invention are various lymphomas, including DLBCL, applicant’s elected disorder to be treated (paragraph 184). Pharmaceutically acceptable compositions, with appropriate carriers, are discussed (paragraph 211).
The difference between this reference and the instant claims is that this reference uses a different drug moiety in their construct and a slightly different linker than the elected species.
Sehn et al discuss a clinical trial of polatuzumab vedotin for DLBCL (title). This is an antibody drug conjugate, with the drug being monomethyl auristatin E (p155, 2nd column, 2nd paragraph), which, as evidenced by Akaiwa et al, is the drug used in applicant’s elected species (fig 1, p202, top of page). Significantly more patients went into remission with this therapy combined with standard of care vs. standard of care alone (p163, 2nd column, 3d paragraph). This reference shows that constructs similar to that claimed by applicant, MMAE combined with a polypeptide binding agent, is effective in treating applicant’s elected disorder.
Therefore, it would be obvious to substitute the MMAE of Sehn et al for the camptothecin analogs of Marshall et al as a simple substitution of one known element for another yielding expected results. As Sehn et al shows a similar construct is effective in that disorder, an artisan in this field would attempt this modification with a reasonable expectation of success.
The combination of references generates a peptide of SEQ ID 1 attached toMMAE via a 1 thio 2 hydroxy cyclopropane ring, attached to the drug via a urethane bond with a nitrogen in the drug. Thus, the combination of references renders obvious claims 80 and 81.
Marshall et al discuss pharmaceutically acceptable formulations with a carrier, rendering obvious claim 82 and 83.
response to applicant’s arguments
Applicants argue that a proper lead compound analysis was not conducted in the rejection, and claimed a high therapeutic index, which is alleged to be an unexpected result.
Applicant's arguments filed 29 July, 2025 have been fully considered but they are not persuasive.
Applicants argue that the lead compound analysis requires the highest affinity compound. This is incorrect. While affinity is a consideration, it is not THE consideration; any reasonable rationale for selecting a specific compound as a starting point is acceptable.
Next, applicants argue that the therapeutic index of their claimed compounds are unexpectedly high. However, applicants have not compared the therapeutic index to the compounds of Marshall et al. Unexpected results are compared to the closest prior art (MPEP 716.02(e)), which is presumed to be the primary reference.
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.
first rejection
Claims 80-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 14 of U.S. Patent No. 12,234,212 view of Sehn et al (J. Clin. Oncol. (2019) 38(2) p155-176), with evidentiary support from Akaiwa et al (Chem. Pharm. Bull. (March 2020) 68(3) 201-211).
Competing claim 1 describes a drug-linker-peptide composition for treating cancer, while competing 5 specifies that the peptide identically as the examined claims. Competing claim 14 requires the linker to be
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, which differs from applicant’s elected linker by the number of methylene groups in the ring, which is not considered a patentable distinction absent secondary considerations (MPEP 2144.09(II)).
The difference between the competing claims and the examined claims is that the competing claims uses a different drug moiety in their construct and a slightly different linker than the elected species.
Sehn et al discuss a clinical trial of polatuzumab vedotin for DLBCL (title). This is an antibody drug conjugate, with the drug being monomethyl auristatin E (p155, 2nd column, 2nd paragraph), which, as evidenced by Akaiwa et al, is the drug used in applicant’s elected species (fig 1, p202, top of page). Significantly more patients went into remission with this therapy combined with standard of care vs. standard of care alone (p163, 2nd column, 3d paragraph). This reference shows that constructs similar to that claimed by applicant, MMAE combined with a polypeptide binding agent, is effective in treating applicant’s elected disorder.
Therefore, it would be obvious to substitute the MMAE of Sehn et al for the camptothecin analogs of the competing claims as a simple substitution of one known element for another yielding expected results. As Sehn et al shows a similar construct is effective in that disorder, an artisan in this field would attempt this modification with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicants argue that there is no motivation to shrink the ring, and that the claimed material has unexpectedly improved therapeutic properties.
Applicant's arguments filed 29 July, 2025 have been fully considered but they are not persuasive.
Applicants argue that there is no motivation to shrink the ring. That difference is not a TSM rationale, but rather that the two rings are patentably indistinct from each other based on legal precedent about homologous series.
Applicants argue superior properties, but have not demonstrated statistical significance (MPEP 716.02(b)(1)).
second rejection
Claims 80-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51, 57, 58, 65, and 68 of copending Application No. 18/174,981 in view of Sehn et al (J. Clin. Oncol. (2019) 38(2) p155-176), with evidentiary support from Akaiwa et al (Chem. Pharm. Bull. (March 2020) 68(3) 201-211).
Competing claim 51 describes a drug-linker-peptide composition for treating cancer, while competing 57 specifies that the peptide selectively delivers the material across a cell membrane in an acidic (<pH 6) or hypoxic mantle. Competing claim 58 lists a small number of peptides, including Pv1, identical with Pv1 of the examined claims, for use in this invention. Competing claim 65 requires the linker to be
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, which differs from applicant’s elected linker by the number of methylene groups in the ring, which is not considered a patentable distinction (MPEP 2144.09(II)). Competing claim 68 describes a small number of compounds, including
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. Note that this differs from applicant’s elected species in the size of the ring of the linker (which, as noted above, is not a patentable distinction) and the therapeutic.
The difference between the competing claims and the examined claims is that the competing claims uses a different drug moiety in their construct and a slightly different linker than the elected species.
Sehn et al discuss a clinical trial of polatuzumab vedotin for DLBCL (title). This is an antibody drug conjugate, with the drug being monomethyl auristatin E (p155, 2nd column, 2nd paragraph), which, as evidenced by Akaiwa et al, is the drug used in applicant’s elected species (fig 1, p202, top of page). Significantly more patients went into remission with this therapy combined with standard of care vs. standard of care alone (p163, 2nd column, 3d paragraph). This reference shows that constructs similar to that claimed by applicant, MMAE combined with a polypeptide binding agent, is effective in treating applicant’s elected disorder.
Therefore, it would be obvious to substitute the MMAE of Sehn et al for the camptothecin analogs of the competing claims as a simple substitution of one known element for another yielding expected results. As Sehn et al shows a similar construct is effective in that disorder, an artisan in this field would attempt this modification with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicants argue that the competing claims are a CON of the primary reference of the first obviousness rejection, and reference the arguments used for that rejection. Those arguments were answered there.
third rejection
Claims 80-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 12 of US Patent No. 11,555,019 (reference application) in view of Sehn et al (J. Clin. Oncol. (2019) 38(2) p155-176), with evidentiary support from Akaiwa et al (Chem. Pharm. Bull. (March 2020) 68(3) 201-211).
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Competing claim 1 describes a drug-linker-peptide composition, while competing 2 specifies that the peptide selectively delivers the material across a cell membrane in an acidic (<pH 6) or hypoxic mantle. Comepting claim 3 lists a small number of peptides, including Pv1, identical with Pv1 of the examined claims, for use in this invention. Competing claim 12 requires the linker to be
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, which differs from applicant’s elected linker by the number of methylene groups in the ring, which is not considered a patentable distinction (MPEP 2144.09(II)).
The difference between the competing claims and the examined claims is that the competing claims uses a different drug moiety in their construct and a slightly different linker than the elected species.
Sehn et al discuss a clinical trial of polatuzumab vedotin for DLBCL (title). This is an antibody drug conjugate, with the drug being monomethyl auristatin E (p155, 2nd column, 2nd paragraph), which, as evidenced by Akaiwa et al, is the drug used in applicant’s elected species (fig 1, p202, top of page). Significantly more patients went into remission with this therapy combined with standard of care vs. standard of care alone (p163, 2nd column, 3d paragraph). This reference shows that constructs similar to that claimed by applicant, MMAE combined with a polypeptide binding agent, is effective in treating applicant’s elected disorder.
Therefore, it would be obvious to substitute the MMAE of Sehn et al for the camptothecin analogs of the competing claims as a simple substitution of one known element for another yielding expected results. As Sehn et al shows a similar construct is effective in that disorder, an artisan in this field would attempt this modification with a reasonable expectation of success.
response to applicant’s arguments
Applicants argue that this is the parent of the application used in the first double patenting rejection, and reference the arguments used for that rejection. Those arguments were answered there.
fourth rejection
Claims 80-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 10 of US Patent No. 11,634,508 (reference application) in view of Sehn et al (J. Clin. Oncol. (2019) 38(2) p155-176), with evidentiary support from Akaiwa et al (Chem. Pharm. Bull. (March 2020) 68(3) 201-211).
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Competing claim 1 describes a drug-linker-peptide composition, while competing 2 specifies that the peptide selectively delivers the material across a cell membrane in an acidic (<pH 6) or hypoxic mantle. Comepting claim 3 lists a small number of peptides, including Pv1, identical with Pv1 of the examined claims, for use in this invention. Competing claim 10 requires the linker to be
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, which differs from applicant’s elected linker by the number of methylene groups in the ring, which is not considered a patentable distinction (MPEP 2144.09(II)). While the competing claims do not specify the utility of the invention, the disclosure states its for treatment of cancer (column 66, line 63). Note that the utility of the competing claims is one of the few areas that a competing disclosure can be used in a double patenting rejection (MPEP 804 (II)(B)(1)).
The difference between the competing claims and the examined claims is that the competing claims uses a different drug moiety in their construct and a slightly different linker than the elected species.
Sehn et al discuss a clinical trial of polatuzumab vedotin for DLBCL (title). This is an antibody drug conjugate, with the drug being monomethyl auristatin E (p155, 2nd column, 2nd paragraph), which, as evidenced by Akaiwa et al, is the drug used in applicant’s elected species (fig 1, p202, top of page). Significantly more patients went into remission with this therapy combined with standard of care vs. standard of care alone (p163, 2nd column, 3d paragraph). This reference shows that constructs similar to that claimed by applicant, MMAE combined with a polypeptide binding agent, is effective in treating applicant’s elected disorder.
Therefore, it would be obvious to substitute the MMAE of Sehn et al for the camptothecin analogs of the competing claims as a simple substitution of one known element for another yielding expected results. As Sehn et al shows a similar construct is effective in that disorder, an artisan in this field would attempt this modification with a reasonable expectation of success.
response to applicant’s arguments
Applicants argue that this is the patent resulting from the PGPub used in the first obviousness rejection, and reference the arguments used for that rejection. These arguments were answered there.
New Rejections
Double Patenting
The legal basis for obvious type double patenting rejections was given above, and will not be repeated here.
fifth rejection
Claims 80-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 27, and 30 Application No. 19/030,299 in view of Sehn et al (J. Clin. Oncol. (2019) 38(2) p155-176), with evidentiary support from Akaiwa et al (Chem. Pharm. Bull. (March 2020) 68(3) 201-211).
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Competing claim 1 describes a drug-linker-peptide composition, with a maytansinoid as the drug. Competing claim 27 gives an example with a maytansinoid attached to a peptide of Pv1 (identical with the peptide of applicant’s elected species, connected by a linker with the structure:
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, which differs from applicant’s elected linker by the number of methylene groups in the ring, which is not considered a patentable distinction (MPEP 2144.09(II)). Competing claim 30 specifies a method where it is administrated, which requires a carrier.
The difference between the competing claims and the examined claims is that the competing claims uses a different drug moiety in their construct and a slightly different linker than the elected species.
Sehn et al discuss a clinical trial of polatuzumab vedotin for DLBCL (title). This is an antibody drug conjugate, with the drug being monomethyl auristatin E (p155, 2nd column, 2nd paragraph), which, as evidenced by Akaiwa et al, is the drug used in applicant’s elected species (fig 1, p202, top of page). Significantly more patients went into remission with this therapy combined with standard of care vs. standard of care alone (p163, 2nd column, 3d paragraph). This reference shows that constructs similar to that claimed by applicant, MMAE combined with a polypeptide binding agent, is effective in treating applicant’s elected disorder.
Therefore, it would be obvious to substitute the MMAE of Sehn et al for the camptothecin analogs of the competing claims as a simple substitution of one known element for another yielding expected results. As Sehn et al shows a similar construct is effective in that disorder, an artisan in this field would attempt this modification with a reasonable expectation of success.
sixth rejection
Claims 80-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 49, and 51 Application No. 19/281,226 in view of Sehn et al (J. Clin. Oncol. (2019) 38(2) p155-176), with evidentiary support from Akaiwa et al (Chem. Pharm. Bull. (March 2020) 68(3) 201-211).
Competing claim 1 describes camptothecin derivatives conjugated to a peptide via a linker. Competing claim 49 specifies a Markush group of compounds, including
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, identical with applicant’s elected species save for a different therapeutic moiety. Competing claim 51 specifies a method that requires administration, which requires a carrier.
The difference between the competing claims and the examined claims is that the competing claims uses a different drug moiety in their construct.
Sehn et al discuss a clinical trial of polatuzumab vedotin for DLBCL (title). This is an antibody drug conjugate, with the drug being monomethyl auristatin E (p155, 2nd column, 2nd paragraph), which, as evidenced by Akaiwa et al, is the drug used in applicant’s elected species (fig 1, p202, top of page). Significantly more patients went into remission with this therapy combined with standard of care vs. standard of care alone (p163, 2nd column, 3d paragraph). This reference shows that constructs similar to that claimed by applicant, MMAE combined with a polypeptide binding agent, is effective in treating applicant’s elected disorder.
Therefore, it would be obvious to substitute the MMAE of Sehn et al for the camptothecin analogs of the competing claims as a simple substitution of one known element for another yielding expected results. As Sehn et al shows a similar construct is effective in that disorder, an artisan in this field would attempt this modification with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658