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 .
Claim Rejections 35 USC 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 11,357,828. This is a statutory double patenting rejection.
Non-Statutory 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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable
over claims 1-20 of U.S. Patent No. 11,957,735. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘735 patent teaches:
A compound of Formula (I)
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(I)
or a pharmaceutically acceptable salt thereof, wherein:
the aliphatic moiety is selected from a polyethylene glycol having an average molecular weight from about 500 Da to about 40,000 Da;
D is a residue of a GLP-1 polypeptide or an analog thereof;
Z1 is selected from O, S, and N(RN);
Z3 is selected from O and N(RN), or Z3 is absent;
A is O or N, wherein when A is O then R3 is absent;
RN is selected from H and optionally substituted C1-6 alkyl;
R3 is selected from H and C1-6 alkyl, or
R3 and R1, together with A and the carbon atom to which R1 is attached, form an optionally substituted 4 to 7 membered aliphatic heterocyclic ring; or
R3 and R2, together with A, the carbon atom to which R1 is attached, and the carbon atom to which R2 is attached, form an optionally substituted 4 to 8 membered aliphatic heterocyclic ring;
MA is a self-immolative group having any one of formulae (a)-(i):
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(a);
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(b);
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(c);
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(d);
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(e);
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(f);
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(g);
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(h);
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(i);
wherein x denotes a point of attachment to Z1 and y denotes a point of attachment to Z3;
R1 and R2 are independently selected from the group consisting of hydrogen, optionally substituted C1-6 alkyl, optionally substituted C6-10 aryl and optionally substituted 5- to 14-membered heteroaryl;
or R1and R2 are joined together with the carbon atoms to which they are attached to form an optionally substituted C3-7 cycloalkyl ring, an optionally substituted 4 to 7 membered aliphatic heterocyclic ring, an optionally substituted C6-10 aryl or an optionally substituted 5- to 14-membered heteroaryl;
or R1 and R2 are joined together to form a ribose ring system;
R7 and R8 are independently selected from H and C1-6 alkyl; and
E is a cleavable moiety.
This meets the limitations of claim 1 by teaching the exact same variable for each functional group and teaching PEG polymer for the aliphatic moiety. As such, claim 1 is unpatentable over ‘735 without a terminal disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11/786,599. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘599 teaches:
A compound of formula (B) for releasing a biologically active drug:
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(I)
or a pharmaceutically acceptable salt thereof, wherein:
the aliphatic moiety is selected from a polymer, RP, and a group selected from:
polymer-L-(CH2)m- and polymer-L-(CH2-CH2-O)p-(CH2)m-;
RP is selected from optionally substituted C1-6 alkyl, optionally substituted C1-3 alkyl-O-(CH2-CH2-O)p-(CH2)m-, and optionally substituted C3-7 cycloalkyl;
L is a linking group;
m and p are each independently an integer from 1 to 10;
D is a residue of a GLP-1 polypeptide or an analog thereof;
Z1 is selected from O, S, and N(RN);
Z3 is selected from O and N(RN), or Z3 is absent;
A is O or N, wherein when A is O then R3 is absent;
RN is selected from H and optionally substituted C1-6 alkyl;
R3 is selected from H and C1-6 alkyl, or
R3 and R1, together with A and the carbon atom to which R1 is attached, form an optionally substituted 4 to 7 membered aliphatic heterocyclic ring; or
R3 and R2, together with A, the carbon atom to which R1 is attached, and the carbon atom to which R2 is attached, form an optionally substituted 4 to 8 membered aliphatic heterocyclic ring;
MA is a self-immolative group having any one of formulae (a)-(i):
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(a);
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(b);
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(c);
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(d);
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(e);
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(f);
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(g);
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(h);
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(i);
wherein x denotes a point of attachment to Z1 and y denotes a point of attachment to Z3;
R1 and R2 are independently selected from the group consisting of hydrogen, optionally substituted C1-6 alkyl, optionally substituted C6-10 aryl and optionally substituted 5- to 14-membered heteroaryl;
or R1and R2 are joined together with the carbon atoms to which they are attached to form an optionally substituted C3-7 cycloalkyl ring, an optionally substituted 4 to 7 membered aliphatic heterocyclic ring, an optionally substituted C6-10 aryl or an optionally substituted 5- to 14-membered heteroaryl;
or R1 and R2 are joined together to form a ribose ring system;
R7 and R8 are independently selected from H and C1-6 alkyl; and
E is a cleavable moiety,
wherein said compound of Formula (B) is capable of releasing said biologically active drug upon activation of said self-immolative group.
This meets the limitations of claim 1 by teaching the exact same variable for each functional group because Formula (B) is identical to instantly claimed formula (I). As such, claim is unpatentable over ‘599 without a terminal disclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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