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 .
Claims Status and Previous Objections/Rejections Status
Claims 1-20 are pending in the application. Claims 2,3 and 18-20 are withdrawn from consideration.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
Applicant’s statement that the present application and Weichert were, not later than the effective filing date of the claimed invention in the present application, owned by or subject to an obligation of assignment to Wisconsin Alumni Research Foundation.
Terminal Disclaimers
The terminal disclaimers filed on 12/1/25 for 19/053,084; 18/182,850; 19/053,072; 18/345,385; 11,730,834; 11,633,506 and 10,751,430 were approved.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 12/1/25, with respect to the rejection(s) of claim(s) 1 and 4-17 under 102(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Pinchuk et al. (US2010/0284931A1) in view of Port (US2007/0292354A1) and in further view of Garrity et al. (US 6,045,821).
New Grounds of Rejection
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1,4-6,8 and 11-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk et al. (US2010/0284931A1) in view of Port (US2007/0292354A1) and in further view of Garrity et al. (US 6,045,821).
Pinchuk et al. (US2010/0284931A1) discloses fluorescent phospholipid compounds having the formula
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wherein X is
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and Z is a fluorophore (p1-2, [0009-0012]).
The different compounds include:
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(p5,
[0069]; p6, [0079]).
The
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moiety encompasses the
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when a is 0, m is 0 and b is 1, such as the
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moiety of the instant claims.
The
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moiety comprises –(CH2)18- that encompasses n is an integer
between 12 and 20, such as 18 of the instant claim 11.
The
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moiety comprises an -N+Me3 moiety that encompasses the -N+Z3 wherein Z is -CH3 of the instant claims 12-14.
The compounds can be combined with a pharmaceutically acceptable carrier (p8, [0097]) that encompasses the pharmaceutically acceptable carrier of the instant claim 17.
Pinchuk et al. does not disclose the metal chelator attached to the phospholipid ether.
Port (US2007/0292354A1) discloses CEST MRI imaging agents comprising DOTA, DO3A, DTPA bound to lipophilic derivatives via a spacer
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(p4, [0056],[0059]; p7, [0137-0139]; p8, [0155]; claims 30,31).
The DOTA, DO3A and DTPA encompass the chelators of the instant claims.
Examples of the contras agents include, DO3A-dodecenyl-PE,
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, etc. (p8-9, [0155],[0165]).
The metal comprises holmium (III), Cu(II), etc. (claim 28).
Garrity et al. (US 6,045,821) discloses chelating agent contrast agent, for MRI, comprising a metal ion and a macrocyclic chelant moiety attached to a lipophilic membrane associating moiety (abstract; column 4, lines 42+).
The chelant moieties comprise
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the Z is CO2H, CON(R2)2, R2, etc. wherein R2 is H, an alkyl substituted by at least one hydroxyl, etc. (column 5, lines 27+).
The chelators comprise DOTA, DO3A (claim 7) that encompass the chelators of the instant claims.
The phospholipids that can be used as anchoring groups to couple to the chelate moiety include phosphatidylethanolamine, N-dodecanal-PE, etc. (column 6, lines 43-54).
The metal comprises Gd(III), Ho(III), 90Y, 186Re, 188Re, etc. (column 13, lines 1-17).
The contrast agent may be combined with an aqueous carrier medium (column 3, lines 41-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the fluorophore moiety of Pinchuk et al. for the metal chelator of Port and/or Garrity et al. to chelate a variety of metal isotopes, such as the 90Y, 186Re, 188Re to the chelator-phospholipid compounds for the advantage of imaging of tumors in a subject via MRI or scintigraphic imaging.
It would have been predictable to one of ordinary skill in the art to substitute one imaging moiety, such as a fluorophore for another imaging moiety, such as a metal chelating contrast agent depending on the desired imaging technique, such as fluorescence, MRI, etc.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 12/1/25, with respect to the rejection(s) of claim(s) 1 and 4-17 on the grounds of nonstatutory double patenting have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over a.) U.S. Patent No. 10,265,398B2 in view of Garrity et al. (US 6,045,821), b.) U.S. Patent No. 10,813,998B2 in view of Garrity et al. (US 6,045,821) and c.) U.S. Patent No. 11,623,007B2 in view of Garrity et al. (US 6,045,821).
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.
Claims 1, and 4-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3-7 and 14-16 of U.S. Patent No. 10,265,398B2 in view of Garrity et al. (US
6,045,821).
The compounds of U.S. Patent No. 10,265,398B2 have an analogous structure to the compounds of the instant claims.
The compounds of U.S. Patent No. 10,265,398B2 and the instant claims have a formula
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wherein R1 are chelates, such as DO3A, NODA, NOTA, DOTA, etc. and chelate metal isotopes.
The Y moieties of U.S. Patent No. 10,265,398B2 and the instant claims comprise -H, -OH, -COOH, etc.
The R2 moieties of U.S. Patent No. 10,265,398B2 and the instant claims comprise -N+H3, -N+H2Z, -N+HZ2, etc. wherein Z is alkyl or arylalkyl.
The method of detecting or imaging one or more cancer tumor cells, the method of diagnosing cancer, the method of monitoring the efficacy of a cancer therapy and the method of treating a cancer of U.S. Patent No. 10,265,398B2 uses the compounds having a formula
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that is analogous to the compounds of the instant claims.
U.S. Patent No. 10,265,398B2 does not disclose the metal atoms of the instant claims 4 and 5.
Garrity et al. (US 6,045,821) discloses chelating agent contrast agent, for MRI, comprising a
metal ion and a macrocyclic chelant moiety attached to a lipophilic membrane associating moiety as well as that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to substitute the Gd moiety of U.S. Patent No. 10,265,398B2 for the 90Y, 186Re, 188Re, etc. of Garrity et al. as Garrity et al. teaches that Gd(III) metal is predictably substituted for the 90Y, 186Re, 188Re, etc. metals for the advantage of imaging of tumors in a subject via different imaging techniques, such as MRI or scintigraphic imaging.
Claims 1 and 4-17 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,813,998B2 in view of Garrity et al. (US 6,045,821).
The compounds used for the method of treating cancer of U.S. Patent No. 10,813,998B2
comprise an analogous structure to the compounds of the instant claims.
The compounds of U.S. Patent No. 10,813,998B2 and the instant claims have a formula
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wherein R1 are chelates, such as DO3A, NODA, NOTA, DOTA, etc. and chelate metal isotopes.
The Y moieties of U.S. Patent No. 10,813,998B2 and the instant claims comprise -H, -OH, -COOH, etc.
The R2 moieties of U.S. Patent No. 10,813,998B2 and the instant claims comprise -N+H3, -N+H2Z, -N+HZ2, etc. wherein Z is alkyl or arylalkyl.
U.S. Patent No. 10,813,998B2 does not disclose the metal atoms of the instant claims 4 and 5.
Garrity et al. (US 6,045,821) discloses chelating agent contrast agent, for MRI, comprising a
metal ion and a macrocyclic chelant moiety attached to a lipophilic membrane associating moiety as
well as that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the Gd moiety of U.S. Patent No. 10,265,398B2 for the 90Y, 186Re, 188Re, etc. of Garrity et al. as Garrity et al. teaches that Gd(III) metal is predictably substituted for the 90Y, 186Re, 188Re, etc. metals for the advantage of imaging of tumors in a subject via different imaging techniques, such as MRI or scintigraphic imaging.
Claims 1 and 4-17 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,623,007B2 in view of Garrity et al. (US 6,045,821).
The compounds of U.S. Patent No. 11,623,007B2 have an analogous structure to the compounds of the instant claims.
The compounds of U.S. Patent No. 11,623,007B2 and the instant claims have a formula
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wherein R1 are chelates, such as DO3A, NODA, NOTA, DOTA, etc. and chelate metal isotopes.
The Y moieties of U.S. Patent No. 11,623,007B2 and the instant claims comprise -H, -OH, -COOH, etc.
The R2 moieties of U.S. Patent No. 11,623,007B2 and the instant claims comprise -N+H3, -N+H2Z, -N+HZ2, etc. wherein Z is alkyl or arylalkyl.
The method of detecting or imaging one or more cancer tumor cells and the method of diagnosing cancer of U.S. Patent No. 11,623,007B2 used the compounds having a formula
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that is analogous to the compounds of the instant claims.
U.S. Patent No. 11,623,007B2 does not disclose the metal atoms of the instant claims 4 and 5.
Garrity et al. (US 6,045,821) discloses chelating agent contrast agent, for MRI, comprising a metal ion and a macrocyclic chelant moiety attached to a lipophilic membrane associating moiety as well as that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the Gd moiety of U.S. Patent No. 10,813,998B2 for the 90Y, 186Re, 188Re, etc. of Garrity et al. as Garrity et al. teaches that Gd(III) metal is predictably substituted for the advantage of imaging of tumors in a subject via different required imaging techniques, such as MRI or scintigraphic imaging.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618