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 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 Status
Claims 1-32 are cancelled.
Claims 33-51 are newly added.
Claims 33-51 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Anticipation Rejection
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.
1) Claim 51 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saltzman (US 9,895,451).
Claim 51 is drawn to a “method of administering one or more therapeutic, diagnostic, or prophylactic agents, the method comprising administering to a subject or a cell in need thereof.” It is initially noted that one or more limitations may be missing from the claim that would more closely relate claim 51 to the instantly claimed invention.
Saltzman teaches polyamine-co-ester- co-ortho ester) polymers, methods of forming active agent loaded nanoparticles of these polymers, as well as methods of using the nanoparticles for drug delivery (Abstract).
Nonstatutory Double Patenting Rejections
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
1) Claims 33-49 are rejected under the judicially created doctrine of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,814,464.
Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claim 33 is drawn to a polymer comprising: i) a plurality of units of formula:
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;
and ii) two end groups each independently comprising a hydroxyl group, a primary amine group, a secondary amine group, or a tertiary amine group; wherein: n is an integer from 1-30; m, o, and p are independently integers from 1-20; Rx is hydrogen, substituted or unsubstituted alkyl, substituted or unsubstituted aryl, or substituted or unsubstituted alkoxy, and Z and Z' are independently O or NR', wherein R' is hydrogen, substituted or unsubstituted alkyl, or substituted or unsubstituted aryl.
Conflicting claim 1 is drawn to a formulation comprising a polymer of Formula I:
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228
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wherein n is an integer from 1-30, m, o, and p are independently integers from 1-20, x, y, and q are independently integers from 1-1000, Rx is hydrogen, substituted or unsubstituted alkyl, or substituted or unsubstituted aryl, or substituted or unsubstituted alkoxy, Z and Z′ are independently O or NR′, wherein R′ is hydrogen, substituted or unsubstituted alkyl, or substituted or unsubstituted aryl, wherein R1 and R2 are chemical entities containing a hydroxyl group, a primary amine group, a secondary amine group, a tertiary amine group, or combinations thereof.
The instant and conflicting claims differ because conflicting claim 1 limits q, x, and y to 1-1000. This limitation is not recited by the instant claims, which limit q, x, and y to 1. Nevertheless, the subject matter of conflicting claim 1 appears to be within the scope of that of instant claim 33, resulting in non-statutory double patenting.
2) Claims 33-50 are rejected under the judicially created doctrine of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,030,985.
Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claim 33 is drawn to a polymer comprising: i) a plurality of units of formula:
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; and ii) two end groups each independently comprising a hydroxyl group, a primary amine group, a secondary amine group, or a tertiary amine group; wherein: n is an integer from 1-30; m, o, and p are independently integers from 1-20; Rx is hydrogen, substituted or unsubstituted alkyl, substituted or unsubstituted aryl, or substituted or unsubstituted alkoxy, and Z and Z' are independently O or NR', wherein R' is hydrogen, substituted or unsubstituted alkyl, or substituted or unsubstituted aryl.
Conflicting claim 1 is drawn to method of administering one or more therapeutic, diagnostic, or prophylactic nucleic acid agents, or combinations thereof in vivo, comprising administering to a subject or a cell in need thereof a polyplex or solid-core particle comprising the one or more therapeutic, prophylactic, or diagnostic nucleic acid agents and a polymer of Formula I:
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wherein n is an integer from 1-30, m, o, and p are independently integers from 1-20, x, y, and q are independently integers from 1-1000, Rx is hydrogen, substituted or unsubstituted alkyl, or substituted or unsubstituted aryl, or substituted or unsubstituted alkoxy, Z and Z′ are independently O or NR′, wherein R′ is hydrogen, substituted or unsubstituted alkyl, or substituted or unsubstituted aryl, wherein R1 and R2 are chemical entities containing a hydroxyl group, a primary amine group, a secondary amine group, a tertiary amine group, or combinations thereof.
The instant and conflicting claims differ because conflicting claim 1 recites a method comprising the polymer recited in instant claim 33, as well as limits q, x, and y to 1-1000. This limitation is not recited by the instant claims, which limit q, x, and y to 1. Nevertheless, the subject matter of conflicting claim 1 appears to be within the scope of that of instant claim 33, resulting in non-statutory double patenting.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612