DETAILED ACTION
The amendment submitted on March 23, 2026 has been entered. Claims 21-40 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 (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.
Withdrawn Rejections
The rejection of claim 40 under 35 U.S.C. 112(b) as being indefinite is withdrawn because the claim has been amended to refer to “FABP3, FABP5 or FABP7.”
The rejection of claim 40 under 35 U.S.C. 112(d) as being of improper dependent form is likewise withdrawn.
Response to Arguments
Applicant argues asserts an unexpected result in rebuttal of the rejection. Briefly, applicant argues that there are at least twelve FABP isoforms (FABP1-FABP12) known in the art, but Ojima does not disclose the effects on FABP isoforms other than FABP5. According to applicant, Ojima only indicates that certain compounds may be selective, but does not specifically disclose the selectivity across the FABP family. Accordingly, a person of ordinary skill in the art would not have understood which FABP isoforms would be selectively inhibited by the compounds. See applicant’s Remarks, submitted March 23, 2026, at pp. 17-19. When considering allegations of unexpected results, differences between a claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. See MPEP 716.02. Applicant bears the burden of presenting evidence that that the differences in results are, in fact, unobvious and “practical significance.” See MPEP 716.02(b). Furthermore, whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the objective evidence of nonobviousness must be “commensurate in scope” with the claims which the evidence is offered to support. In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See MPEP 716.02(d). Claims 21-38 are drawn to compounds or compositions, so the claims are not commensurate in scope with applicant’s observations about the activity with respect to the various types of FABP. Stated another way, claims 21-38 read on the any and all methods of using the compounds, so they cannot be regarded as being limited to any particular FABP isotype. Furthermore, with respect to claims 39-40, applicant has not explained what the “practical significance” of inhibiting FABP3, FABP5 or FABP7 would be. Applicant’s arguments have been fully considered but are not persuasive. The rejection under § 103 is therefore maintained.
Applicant has not substantively responded to the various rejections for double patenting, so they are each maintained.
Claim Rejections – 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-29 and 32-40, as amended, remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/015276 A1 by Ojima et al.
Ojima (cited in the prior action) generally discloses (p. 3) compounds having the following chemical structure:
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Note the stereochemistry of the carbon atom marked with the arrow, above. The stereochemistry of this carbon atom is different than the claims at issue. The reference, however, explains that “each stereogenic carbon may be of the R or S configuration” and “the isomers arising from such asymmetry (e.g., all enantiomers and diastereomers) are included” (p. 39, ll. 2-4). Therefore, even though the reference does not specifically disclose compounds having the same stereochemistry requires by the instant claims, this subject matter would nevertheless have been prima facie obvious.
Furthermore, the reference (p. 32) discloses the following example compound:
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Note that this compound has R3 through R12 as hydrogen and is therefore excluded by the provisos at the end of claims 21-23. However, by making some relatively trivial changes to this structure in the manner directed by the reference, one arrives at compounds within the scope of the instant claims. For example, the reference provides (see, e.g., p. 29, ll. 14-17) that “R3, R4, R5, R6, R7, R8, R9, R10, R11 and R12 are each independently, H, halogen, -NO2, -CN, -NHR15, -NR15R16, -SR15, -SO2R15, -OR15, -CO2R15, CFз, -alkyl-NR15R16, -alykl-OR15, C1-10 alkyl, C2-10 alkenyl, C2-10 alkynyl, aryl, heteroaryl, or heterocyclyl,” wherein R15 and R16 are, among other things, hydrogen. It is implicit that these functional groups are more or less equivalent. By substituting the hydrogen atoms in substituents R3 through R12 in the chemical structure above in accordance with the instructions provided by the reference, one avoids the proviso at the end of claims 21-23. Generally, substituting one functional group for another equivalent functional group in this manner would have been viewed as a matter of routine experimentation and therefore prima facie obvious. See MPEP 2144.06(II) (substituting equivalents known for the same purpose). The subject matter of claim 34 is likewise prima facie obvious. Compounds having the naphthyl groups in limitation “(a)” of claim 32 would have been prima facie obvious for similar reasons. The teaching that the R3-R12 groups are independently H or NO2 (see, e.g., p. 29, ll. 14-15) would have suggested limitation “(d)” of claim 35.
Regarding claims 25-26, the reference teaches that R1 or R2 is --C(=O)OR13, wherein R13 is alkyl (p. 3, ll. 6-15), and wherein “alkyl” in this context is defined as being a C1-C6 alkyl group (p. 40, ll. 26-34), or more particularly, a C1 group (p. 40, l. 31-33) that is “further substituted by replacing one or more hydrogen atoms with alternative non-hydrogen groups, such as “halo, hydroxy, mercapto, amino, carbоху, суano, carbamoyl and aminocarbonyl and aminothiocarbonyl” (p. 40, ll. 5-10).
Regarding claims 27-29, the reference teaches that the R13 group is an aryl or heteroaryl group (p. 3, ll. 12-15), and the “aryl [and] heteroaryl … groups can be further substituted by replacing one or more hydrogen atoms with alternative non-hydrogen groups,” such as “halo, hydroxy,” and so forth (p. 40, ll. 5-10).
With respect to the specific compounds of claim 36, the reference generally teaches a compound in which “R1 and R2 are different and are each -C(=O)R13 [or] -C(=O)OR13” (p. 3, l. 6), wherein each R13 is each independently H or cycloalkyl (p. 3, ll. 12-13), and wherein the cycloalkyl group is, among other things, a cyclohexyl group (p. 42, ll. 6-8). The reference also teaches that “R3, R4, R5, R6, R7, R8, R9, R10, R11 and R12 are each independently, H” (p. 3, l. 17). Following these instructions, one arrives at the first compound of claim 36, except for the stereocenter marked with the arrow, above. The reference, however, explains that “each stereogenic carbon may be of the R or S configuration” and “the isomers arising from such asymmetry (e.g., all enantiomers and diastereomers) are included” (p. 39, ll. 2-4). The examiner therefore concludes that at least the first compound recited in claim 36 is prima facie obvious. Arriving at this subject matter would have been viewed as merely reducing to practice the general teachings of the reference by routine experimentation and thereby arriving at a readily predictable outcome. The first compound recited in claim 36 is also within the scope of claims 21-22, 24, 33, and 37, so the examiner finds these claims also to be prima facie obvious.
Regarding claim 37, the reference discloses “if a chiral center or another form of an isomeric center is present in a compound of the present invention, all forms of such isomer or isomers, including enantiomers and diastereomers” (p. 37, ll. 18-21).
Regarding claim 38, the reference discloses pharmaceutical compositions (pp. 49-55).
Regarding claims 39-40, the reference discloses “ a method of inhibiting the activity of a Fatty Acid Binding Protein (FABP) comprising contacting the FABP” (p. 27, ll. 4-5) with one of the compounds described above. In this method, “the compound inhibits binding of an FABP ligand to the FABP” (p. 32, ll. 5-6). With regard to the amendment to claim 40, the reference discloses that the compounds are “small molecule inhibitors of FABP5 and FABP7” (p. 85, ll. 32-33).
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 21-29 and 32-40 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 15-22 of U.S. Patent No. 9,604,904 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘904 Patent is equivalent to WO 2014/015276 A1 by Ojima et al., discussed above. The instant claims are not patentably distinct from the claims of the ‘904 Patent for substantially the same reasons discussed above. For example, claim 2 of the ‘904 Patent is directed to compounds having the following chemical structure:
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“wherein one of R1 or R2 is —C(═O)OR13, … , wherein R13 is an unsubstituted bicyclic aryl or unsubstituted heteroaryl; and the other of R1 or R2 is —C(═O)OH.” See claim 2 of the ‘904 Patent also provides that “R3, R4, R5, R6, R7, R8, R9, R10, R11, and R12 are each independently, H” or -OR15, wherein R15 is hydrogen, i.e., R5 and R10 may each be a hydroxyl group. Claim 3 provides for R1 or R2 as a 1-naphthyl group. Taken together these limitations would have suggested the second compound recited in claim 36. Similar observations may be made with respect to the other claims. Claim 15 of the ‘904 Patent is drawn to a method of inhibiting the activity of a Fatty Acid Binding Protein (FABP) comprising contacting the FABP with the compound. Claim 19 is drawn to a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
Claims 21-29 and 32-40 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,213,406 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. For example, claim 1 of the ‘406 Patent is drawn to method of inhibiting the activity of a Fatty Acid Binding Protein (FABP) comprising contacting the FABP with a compound having the structure:
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Even though no stereochemistry is indicated in this chemical structure, the specification of the ‘406 Patent (see, e.g., col. 32, ll. 1-5) teaches all such enantiomers and diastereomers, so the particular stereochemistry of the instant claims would have been prima facie obvious. Claim 1 of the ‘406 Patent further provides that “one of R1 or R2 is —C(═O)R13” and “the other of R1 or R2 is —C(═O)OR13, wherein R13 is H,” wherein “wherein R13 and R14 are each, independently, … heteroalkyl, cycloalkyl, aryl, heteroaryl,” which suggests the limitations of at least instant claim 21.
Claims 21-40 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,968,163 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the ‘163 Patent are drawn to chemical compounds (see, e.g., claim 1) and pharmaceutical compositions (claim 14) that are used in a “method of inhibiting the activity of a Fatty Acid Binding Protein (FABP) comprising contacting the FABP” (see abstract). The ‘163 Patent claims specific compounds that are also claimed in the instant application; for example, the first compound of claim 19 of the ‘163 Patent is the same compound of instant claim 36.
Claims 21-40 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,739,047 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The instant application is a divisional of the ‘047 Patent; however, both the ‘047 Patent and the instant claims are drawn toa method of inhibiting the activity of a Fatty Acid Binding Protein (FABP) comprising contacting the FABP with a compound (compare claim 1 of the ‘047 Patent with instant claim 29). The double patenting safe harbor of 35 U.S.C. 121 is therefore not available to applicant because the instant application is not drawn to subject matter that was necessitated by restriction. The ‘047 application claims compounds that are also specifically claimed in the instant application. For example, the first compound recited in claim 17 of the ‘047 Patent is the same compound recited in instant claim 36.
Claims 21-40 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, 8, 11, 20-21, 25, 32, 35-36, 43, 46-48, 55, 57, and 62-64 of copending Application No. 18/248232 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the ‘232 Application are drawn to a compound having the following structure:
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See claim 2 of the ‘232 Application. In this structure, “one of the R1 or R2 is -C(=O)OH and the other of the R1 or R2 is -C(=O)OR13 or -C(=O)O-alkyl-R14, wherein R13 is cycloalkyl, aryl or heteroaryl” (see claim 1) and the other R substituents substantially overlap with the corresponding substituent definitions in the instant claims. Claims 46-47 of the ‘232 Application are drawn to a pharmaceutical composition of these compounds, as well as a method of inhibiting FABP to a FABP ligand. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. 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 Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
April 29, 2026
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