Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
Claims 1, 3, 8-9, 12-13, 15-17, 21, 23, 26-29, 31, 33, 35, 38-44, and 48 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 1, 3, 8-9, 12-13, 15-17, 21, 23, 26-29, 31, 33, 35, and 38-39, drawn to a pyrrolobenzodiazepine derivative) and the elected species Compound 29 in the reply filed on 11/14/2025 is acknowledged.
Claims 3, 16, 28-29, 33, 38-44, and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups II-III or unelected species, there being no allowable generic or linking claim. Thus, Claims 1, 8-9, 12-13, 15, 17, 21, 23, 26-27, 31, and 35 are being examined on the merits herein.
The requirement is deemed proper and is therefore made final.
Claim Objections
Claims 1, 9, 12-13, 23, and 27 are objected to because of the following informalities:
All notation across claims used to refer to the same groups must be standardized. For example “C(O)” in Claim 13 denotes the same group described in Claim 1, “C(=O)”; however, the notation is different across the claims.
Claim 27 recites “--C(=O)-” instead of “-C(=O)-”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1, 8-9, 12-13, 15, 17, 21, 23, 26-27, and 35 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 regards as the invention.
Claims 1, 9, and 12 recite where C, S, P, C(=O), or C(O) is “bonded to a phenyl ring”. It is unclear whether a phenyl ring refers to the phenyl depicted in Chemical Formula IV or some other phenyl. To resolve the ambiguity, applicant is recommended to amend “a phenyl” to “the phenyl”. Claims 8, 13, 15, 17, 21, 23, 26-27, and 35 are rejected by virtue of dependency.
Claim 1 recites “X is a moiety bonded to Linker 1”. However, the definition of Linker I and the compounds embodied in Claim 31 suggest that X is Linker I, bonded directly to N, rather than some moiety bonded to N and Linker I. Applicant is recommended to amend the above limitation to “X is Linker I”. Claims 8-9, 12-13, 15, 17, 21, 23, 26-27, and 35 are rejected by virtue of dependency.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 35 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.
Claim 35 reads “Ba’ is a bond”. However, Claim 1, upon which Claim 35 depends, precludes “bond” from acceptable embodiments of Ba’.
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.
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.
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.
Claims 1, 8-9, 12-13, 15, 17, 21, 23, 26-27, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Howard (WO2007039752, cited in 6/30/2022 IDS).
Howard teaches compound 23 on Page 43:
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123
293
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in which the following definitions of examined Formula I apply: Q1, Q2, Q3, Q5, and Q7 are H; Q4 is -ORm, wherein Rm is C1alkyl; X is absent; Y is O; Q6 is C3alkyldiyl; B and B’ are each a bond; A1 is CONH; A-1 is pyrrole substituted with C1alkyl; B1 is a bond; A2 is CONH; A-2 is pyrrole substituted with C1alkyl; B2 is a bond; a1 and a2 are each 1; E1 is C(O) and e1 is 1; e2 is 0; and F1 is OMe.
With respect to Claims 8-9, 12-13, 15, and 17, Linker I is absent. The cited claims do not require the presence of a Linker attached to X.
With respect to Claim 35, alternatively the Howard compound may be reinterpreted such that Ba’, Bb’, and Bc’ are all a bond according to Chemical Formula VII.
Claims 1, 8-9, 12-13, 15, 17, 26-27, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (WO2017089894, published 2017).
Kim teaches Compound 54a (Page 199):
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188
448
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, in which the following definitions of examined Chemical Formula I apply: Q1, Q2, Q3, and Q7 are H; Q4 is methoxy; Q5 is hydroxy; Q6 is C5alkylene; Y is O; X is Linker I; Linker I is Chemical Formula IV
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155
255
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, wherein Ra and Rb are each H, s is 0 and G is
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150
139
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; Rc and Rd are H; W is C(O)NR’ wherein R’ is H; L is a “connection unit” represented by
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21
131
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wherein t is 2, V is O, u is 2, and v is 2; Rz is ONH2; B and B’ are both a bond or a and b are both 0; D is
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487
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wherein A1 is O and A-1 is a 14-membered heterocycloalkylene:
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68
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; a2, e1, and e2 are 0; F1 is OCH3.
With respect to Claim 35, alternatively the Kim compound may be reinterpreted such that Ba’, Bb’, and Bc’ are all a bond according to Chemical Formula VII.
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.
PROVISIONAL:
1. Claims 1, 8-9, 12-13, 15, 17, 26-27, and 35 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 13-18 of copending Application No. 17420007 (hereinafter referred to as Legochem).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a genus of glucuronic acid-pyrrolobenzodiazepine derivative compounds.
Legochem teaches Compound 124 (Claim 18):
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216
568
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, in which the following definitions of examined Chemical Formula I apply: Q1, Q2, Q3, and Q7 are H; Q4 is methoxy; Q5 is hydroxy; Q6 is C5alkylene; Y is O; X is Linker I; Linker I is Chemical Formula IV
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155
255
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, wherein Ra and Rb are each H, s is 0 and G is
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150
139
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; Rc and Rd are H; W is C(O)NR’ wherein R’ is H; L is a “connection unit” represented by
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21
131
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wherein t is 2, V is O, u is 2, and v is 2; Rz is ONH2; B and B’ are both a bond or a and b are both 0; D is
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100
487
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wherein A1 is O, A-1 is a substituted 14-membered heterocycloalkylene:
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139
374
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, and B1 is C(O); a2 is 0; E1 is OCH2, wherein e1 is 1; e2 is 0; F1
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96
150
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wherein each member is C. (Applicant does not limit the substituents on the F1 ring, which are glucuronic acid and an ester in the Legochem compound.)
With respect to Claim 35, alternatively the Legochem compound may be reinterpreted such that Ba’, Bb’, and Bc’ are all a bond according to Chemical Formula VII.
Since both applications teach glucuronic acid-pyrrolobenzodiazepine derivative compounds, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Legochem.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
1. Claims 1, 8-9, 12-13, 26-27, and 35 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-29 of U.S. Patent No. 12398124 (hereinafter referred to as Legochem).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a genus of glucuronic acid-pyrrolobenzodiazepine derivatives.
Legochem teaches the following compound in Col 159:
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297
570
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, in which the following definitions of examined Chemical Formula I apply: Q1 is Me; Q2, Q3, and Q7 are H; Q4 is methoxy; Q5 is hydrogen; Q6 is C5alkylene; Y is O; X is Linker I; Linker I is Chemical Formula IV
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155
255
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, wherein Ra and Rb are each H, s is 0 and G is
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150
139
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; Rc and Rd are H; W is C(O)NR’ wherein R’ is H; L is a “connection unit” represented by
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23
125
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, wherein t is 2, V is O, u is 0 and v is 1; Rz is C1alkyl; B and B’ are both a bond or a and b are both 0; D is
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100
487
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wherein A1 is O and A-1 is a 14-membered heterocycloalkylene:
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68
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; a2, e1, and e2 are 0; F1 is OCH3.
With respect to Claim 35, alternatively the Kim compound may be reinterpreted such that Ba’, Bb’, and Bc’ are all a bond according to Chemical Formula VII.
Since both claim sets teach glucuronic acid-pyrrolobenzodiazepine derivative compounds, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Legochem.
2. Claims 1, 8-9, 12-13, 15, 17, 26-27, and 35 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-26 of U.S. Patent No. 9919057 (hereinafter referred to as Legochem).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a genus of pyrrolobenzodiazepine derivatives.
Legochem teaches the following compound:
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101
2
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in which the following definitions of examined Chemical Formula I apply: Q1 is Rm, wherein Rm is substituted aryl (Applicant teaches no limit to the degree or type of substitution in Spec: Page 39); Q2, Q3, Q5, and Q7 are H; Q4 is methoxy; Q6 is C5alkylene; Y is O; X is absent; D is
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100
487
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wherein A1 is O, A-1 is a 14-membered heterocycloalkylene:
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101
2
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, and B1 is a bond; a2, e1, and e2 are 0; F1 is
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103
155
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wherein all ring members are C.
Methods taught in the patent require the presence of the claimed compounds.
With respect to Claims 8-9, 12-13, 15, and 17, Linker I is absent. The cited claims do not require the presence of a Linker attached to X.
With respect to Claim 35, alternatively the Howard compound may be reinterpreted such that Ba’, Bb’, and Bc’ are all a bond according to Chemical Formula VII.
Since both claim sets teach pyrrolobenzodiazepine derivatives, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Lego chem.
3. Claims 1, 8-9, 12-13, 15, 17, 26-27, and 35 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-25 of U.S. Patent No. 9993568 (hereinafter referred to as Legochem).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a genus of pyrrolobenzodiazepine derivatives.
Legochem teaches the following compound:
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101
2
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in which the following definitions of examined Chemical Formula I apply: Q1 is Rm, wherein Rm is substituted aryl (Applicant teaches no limit to the degree or type of substitution in Spec: Page 39); Q2, Q3, Q5, and Q7 are H; Q4 is methoxy; Q6 is C5alkylene; Y is O; X is absent; D is
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100
487
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wherein A1 is O, A-1 is a 14-membered heterocycloalkylene:
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101
2
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, and B1 is a bond; a2, e1, and e2 are 0; F1 is
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103
155
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wherein all ring members are C.
Methods taught in the patent require the presence of the claimed compounds.
With respect to Claims 8-9, 12-13, 15, and 17, Linker I is absent. The cited claims do not require the presence of a Linker attached to X.
With respect to Claim 35, alternatively the Howard compound may be reinterpreted such that Ba’, Bb’, and Bc’ are all a bond according to Chemical Formula VII.
Since both claim sets teach pyrrolobenzodiazepine derivatives, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Lego chem.
4. Claims 1, 8-9, 12-13, 15, 17, 26-27, and 35 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-26 of U.S. Patent No. 10118965 (hereinafter referred to as Legochem).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a genus of pyrrolobenzodiazepine derivatives.
Legochem teaches the following compound:
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101
2
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in which the following definitions of examined Chemical Formula I apply: Q1 is Rm, wherein Rm is substituted aryl (Applicant teaches no limit to the degree or type of substitution in Spec: Page 39); Q2, Q3, Q5, and Q7 are H; Q4 is methoxy; Q6 is C5alkylene; Y is O; X is absent; D is
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100
487
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wherein A1 is O, A-1 is a 14-membered heterocycloalkylene:
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101
2
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, and B1 is a bond; a2, e1, and e2 are 0; F1 is
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103
155
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wherein all ring members are C.
Methods taught in the patent require the presence of the claimed compounds.
With respect to Claims 8-9, 12-13, 15, and 17, Linker I is absent. The cited claims do not require the presence of a Linker attached to X.
With respect to Claim 35, alternatively the Howard compound may be reinterpreted such that Ba’, Bb’, and Bc’ are all a bond according to Chemical Formula VII.
Since both claim sets teach pyrrolobenzodiazepine derivatives, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Lego chem.
5. Claims 1, 8-9, 12-13, 15, 17, 26-27, and 35 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-24 of U.S. Patent No. 10183997 (hereinafter referred to as Legochem).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a genus of pyrrolobenzodiazepine derivatives.
Legochem teaches the following compound:
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101
2
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in which the following definitions of examined Chemical Formula I apply: Q1 is Rm, wherein Rm is substituted aryl (Applicant teaches no limit to the degree or type of substitution in Spec: Page 39); Q2, Q3, Q5, and Q7 are H; Q4 is methoxy; Q6 is C5alkylene; Y is O; X is absent; D is
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100
487
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wherein A1 is O, A-1 is a 14-membered heterocycloalkylene:
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101
2
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, and B1 is a bond; a2, e1, and e2 are 0; F1 is
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103
155
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wherein all ring members are C.
Methods taught in the patent require the presence of the claimed compounds.
With respect to Claims 8-9, 12-13, 15, and 17, Linker I is absent. The cited claims do not require the presence of a Linker attached to X.
With respect to Claim 35, alternatively the Howard compound may be reinterpreted such that Ba’, Bb’, and Bc’ are all a bond according to Chemical Formula VII.
Since both claim sets teach pyrrolobenzodiazepine derivatives, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Lego chem.
6. Claims 1, 8-9, 12-13, 15, 17, 26-27, and 35 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-21 of U.S. Patent No. 10383949 (hereinafter referred to as Legochem).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a genus of pyrrolobenzodiazepine derivatives.
Legochem teaches the following compound:
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101
2
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in which the following definitions of examined Chemical Formula I apply: Q1 is Rm, wherein Rm is substituted aryl (Applicant teaches no limit to the degree or type of substitution in Spec: Page 39); Q2, Q3, Q5, and Q7 are H; Q4 is methoxy; Q6 is C5alkylene; Y is O; X is absent; D is
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100
487
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wherein A1 is O, A-1 is a 14-membered heterocycloalkylene:
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101
2
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, and B1 is a bond; a2, e1, and e2 are 0; F1 is
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103
155
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wherein all ring members are C.
Methods taught in the patent require the presence of the claimed compounds.
With respect to Claims 8-9, 12-13, 15, and 17, Linker I is absent. The cited claims do not require the presence of a Linker attached to X.
With respect to Claim 35, alternatively the Howard compound may be reinterpreted such that Ba’, Bb’, and Bc’ are all a bond according to Chemical Formula VII.
Since both claim sets teach pyrrolobenzodiazepine derivatives, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Lego chem.
Conclusion
No claim is allowable.
Claims 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627