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 .
Receipt is acknowledged of Applicant’s Amendments and Arguments filed on 08/12/2025.
Claims 1, 2, 11, 12, 19 and 21 have been amended.
Claims 3-6 and 14-18 are cancelled. Accordingly, claims 1-2, 7-13, and 19-22 are pending and presented for examination.
Any previous rejections and/or objections not reiterated herein have been withdrawn in view of Amendments and Arguments filed on 08/12/2025. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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 1-13 and 19-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,458,213 (‘213). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a compound of Formula (I) and method of treating cancer,
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wherein Z is tetrazole or COOH; m is integer of 1-5; R is selected from group consisting of substituted aryl, pyridine and unsubstituted isoquinoline; W is selected from group consisting of -NR2-(C=O), -NR2-(C=S), -(C=O)-NR2; R2 is H or C1-C4 alkyl, Chis a chelating agent and pharmaceutically acceptable salt thereof. The claims of ‘213 patent are directed to compounds having the structure shown. The instant claims encompass those of the ‘213 patent because the chelator of the ‘213 claims are within the scope of the instant chelator, the R,W and L of the instant claims are addressed by -NH-C(=O)- and C6 alkylene shown in the ‘213 patent. Accordingly, the claims are overlapping in scope and are obvious variants of one another.
Claims 1-13 and 19-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,448,558 (‘558). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a compound of Formula (I) and their method of treating cancer,
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wherein Z is tetrazole or COOH; m is integer of 1-5; R is selected from group consisting of substituted aryl, pyridine and unsubstituted isoquinoline; W is selected from group consisting of -NR2-(C=O), -NR2-(C=S), -(C=O)-NR2; R2 is H or C1-C4 alkyl, Chis a chelating agent and pharmaceutically acceptable salt thereof. The claims of ‘558 patent are directed to compounds having the structure shown. The instant claims encompass those of the ‘558 patent because the chelator of the ‘558 claims are within the scope of the instant chelator, the R,W and L of the instant claims are addressed by -NH-C(=O)- and C6 alkylene shown in the ‘558 patent. Accordingly, the claims are overlapping in scope and are obvious variants of one another.
Claims 1-13 and 19-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 28 and 31 of U.S. Patent No. 11,813,340 (‘340). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a compound of Formula (I) and method of treating cancer,
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wherein Z is tetrazole or COOH; m is integer of 1-5; R is selected from group consisting of substituted aryl, pyridine and unsubstituted isoquinoline; W is selected from group consisting of -NR2-(C=O), -NR2-(C=S), -(C=O)-NR2; R2 is H or C1-C4 alkyl, Ch is a chelating agent and pharmaceutically acceptable salt thereof. The claims of ‘340 patent are directed to compounds having the structure shown. The instant claims encompass those of the ‘340 patent because the chelator of the ‘340 claims are within the scope of the instant chelator, the R,W and L of the instant claims are addressed by -NH-C(=O)- and C6 alkylene shown in the ‘340 patent. The only difference is that compound of formula (I) that is not radiohalogenated. However, the compound of formula (I) used as a blocking agent, X is a halogen. Accordingly, the claims are overlapping in scope and are obvious variants of one another.
“Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) the education level of active workers in the field.” Envil. Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.3d 1376, 1381-82 (Fed. Cir. 1983)). The above factors are not exhaustive, but are a guide. Id.
In this case, the education level of the inventor and the education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, a person of ordinary skill in the art would likely have at least a college degree in the field of organic chemistry, with industry experience, i.e., a masters or doctorate level of skill and knowledge in the laboratory. Thus, the level of skill in the art is relatively high.
“Structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, create a prima facie case of obviousness.” Takeda v. Alphapharm, 83 USPQ2d 1169 (Fed. Cir. 2007) (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990). “The ‘reason or motivation’ need not be an explicit teaching that the claimed compound will have a particular utility; it is sufficient to show that the claimed and prior art compounds possess a ‘sufficiently close relationship...to create an expectation,’ in light of the totality of the prior art, that the new compound will have ‘similar properties’ to the old.” Aventis v. Lupin, 84 USPQe2d 1197 (Fed. Cir. 2007) (citing Dillion, 919 F.2d 692). “Once such prima facie case is established, it falls to the applicant or patentee to rebut it, for example with a showing that the claimed compound has unexpected properties.” /d.
MPEP 804 states : “where the claims of an application are not the “same” as those of the first patent, but the grant of a patent with the claims in the application would unjustly extend the rights granted by the first patent, a double patenting rejection under nonstatutory grounds is proper.”
Although the conflicting claims are not identical, the Examiner finds that a person having ordinary skill in the art would recognize that the claimed invention would unjustly extend the rights granted to U.S. Patent No. 911,448,558, 11,448,558 and 11,813,340 because a hypothetical infringer of granted patents would necessarily be an infringer of the claimed invention. Accordingly, U.S. Patent No. 911,448,558, 11,448,558 and 11,813,340 renders the instant claims obvious absent a showing of unpredictability or comparative evidence suggesting otherwise are maintained for reasons of record in the previous office action filed on 02/12/2025.
Applicant’s arguments have been fully considered but they are not persuasive. Applicant argues that applicants have demonstrated through comparative evidence disclosed in Example 2 of the instant specification that the compounds and methods of 1-2, 7-13, and 19-22 exhibit unpredictable superior results over representative compounds of the ‘213 and the ‘558 patents. This arguments are not persuasive since additional -CH2 group in the linker moiety would have been obvious to one of ordinary skill in the art to expect similar beneficial results with compounds having only additional -CH2- groups. Case laws holds that homologs (compounds differing regularly by the successive addition of the same chemical group, e.g, by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). The undecyl compound differs from the dodecyl compound by a single -CH2- group, where the functional groups are at either end of the compound. Thus, it would be presumed that the addition of a single -CH2- group would possess similar properties. For these reasons, it would have been obvious to one of ordinary skill in the art to use the dodecyl derivative in light of the undecyl derivative the number of methylene groups present between functional groups and are therefore considered homologs to each other. However, to adjust the number of methylene units in these compounds is within the capabilities of one of ordinary skill in the field of chemistry. The reason to make such a modification is the expectation that compounds similar in structure will have similar properties. Adding or subtracting methylene units in these compounds is prima fascia obvious to one of ordinary skill. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." /n re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
Conclusion
No claims are allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618