DETAILED ACTION
A final Office action was mailed 12 September 2025 (“Office Action”).
Applicant’s reply to the Office Action was received 10 December 2025 (“Reply”).
The Reply was submitted with a Request for Continued Examination (RCE).
Status of the Claims
The listing of claims filed with the Reply and RCE has been entered and examined.
Claims 1, 2, 4, 10, 11, 13, 15, 19, 21, 22, 29, 30, 33, 38, and 47–52 are pending.
Claims 3, 5–9, 12, 14, 16–18, 20, 23–28, 31, 32, 34–37, and 39–46 are canceled.
Claims 1, 2, 4, 11, 30, and 38 are amended. Claims 51 and 52 are new.
Information Disclosure Statement
The information disclosure statement (IDS) submitted with the Reply is acknowledged and has been considered.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Rejections - 35 USC § 103
Claims 1, 2, 4, 10, 11, 13, 15, 19, 21, 22, 29, 30, 33, 34, 38, and 47–52 are rejected under 35 U.S.C. § 103 as being unpatentable over WO 2017/156354 (“Ojima-354”) [IDS] in view of WO2014/015276 (“Ojima-276”), US 8,748,470 (“Lengyel”) [IDS], Liu et al., J. Natural Products (2018), 81, 307–315 (“Liu”), and Hou et al., Biomaterials (2012), 33, 5431–540 (“Hou”).
Determining the scope and contents of the prior art
Ojima-354 discloses a-truxillic acid derivatives with cyclobutyl substituents R1 and R2 being different functional groups: -C(O)OH and -C(O)OR13 or -C(O)O-alkyl-R14. (Ojima-354, pp.5–6) (below left). Ojima-354 discloses six preferred subgenera, including a formula with a methoxy group at the ortho-position of each phenyl group. (Id., p.15) (below right).
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Ojima-354 discloses 30 preferred species, including compounds 4b, 4e, and 4j, which fall within the scope of the above-identified preferred subgenus. (Id., pp.24–27, table).
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Ojima-354 discloses a method of inhibiting a Fatty Acid Binding Protein (FABP) with the compounds. (Id., pp.21–22). Ojima-354 discloses the compounds bind to and reversibly inhibit FABPs, and certain compounds exhibit selectivity for FABP3, FABP5, or FABP7; or are selective for both FABP5 and FABP7. (Id., pp.71–72, Example 2). Ojima-354 states the preferred monoester compounds bind to and reversibly inhibit FABPs. (Id., p. 76).
Ojima-354 discloses a method of treating pain or a neurological disorder that affects at least one of movement, memory, mood, appetite, nociception, endocrine regulation, thermoregulation, sensory perception, or cognitive functions. (Id., pp.28–29).
Ojima-276 discloses a-truxillic acid derivatives and methods of using the compounds as FABP inhibitors. (Ojima-276, pp.3–5, 10–23) (below left). Ojima-276 discloses preferred compounds having different cyclobutyl substituents R1 and R2. (Id., p.5, 18–23) (below right).
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Ojima-276 discloses the compounds of the general formula above can be substituted at one or more of the R3, R7, R8, and R12 positions with -OR15. (Id., pp.3, 5, 10, 12, etc.).
Ojima-276 discloses the compounds can be “a component of a combination therapy.” (Id., 49:9–10) (page:lines). Ojima-276 discloses the combination therapy components can be administered sequentially or simultaneously; and via the same or different routes of administration. (Id., 49:12–17).
Ojima-276 states: “A dosage unit of the compounds used in the method of the present invention may comprise a single compound or mixtures thereof with additional antitumor agents.” (Id., 49:34–36) (emphasis added).
Lengyel discloses a method of treating cancer with a FABP5 inhibitor and an anticancer agent or an anticancer therapy such as radiotherapy (e.g., electron-beam radiation). (Lengyel, claims 1, 4, 7; and 15:8–12; 17:10–18:7; 19:7–28 (column:line)).
Lengyel states the FABP inhibitor may be administered before or after a second anticancer agent. (Id., 17:41–43). Lengyel states the administration can be periodically (“ranging from minutes to weeks”). (Id.; and 20:48–58).
Lengyel discloses the FABP inhibitor can be formulated into a capsule for oral administration. (Id., 23:5–13; 26:30–43).
Lengyel states the subject can be a mammal (e.g., human female). (Id., 26:11; 32:3–24).
Liu discloses cyclobutane-containing chalcone derivatives. Compounds 1, 2, and 5 have structures relevant to the claimed invention—with phenyl groups bonded to opposite carbons of the cyclobutyl ring and other functional groups bonded on the other two carbons of the ring, as shown below. (Liu, p.308).
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Liu discloses the compounds were “tested for their inhibitory activities against the human prostate cancer cell line PC-3 using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) method.” (Id., p.312). Each of the compounds demonstrated activity, as shown in Table 5. (Id., p.313).
Hou states: “Anticancer drugs are normally associated with severe side effects during therapy. Nowadays combination chemotherapy with multiple drugs, a basic chemotherapeutic protocol for cancer, has been widely used in the clinic to solve this problem.” (Hou, p.5431). Hou discloses paclitaxel (PTX) is used in combination with all-trans-retinoid acid (ATRA) for the treatment of cancer, which resulted in enhanced therapeutic efficacy and better safety profiles. (Id., pp.5432, 5439).
Ascertaining the differences between the prior art and the claims at issue
Ojima-354 does not disclose a method of treating cancer in a combination therapy.
Ojima-276 and Lui disclose FABP inhibitors with related structures but do not disclose the specific compounds in the instant claims.
Lengyel discloses FABP inhibitors but not the specific compounds in the instant claims.
Hou discloses combination therapies for treating cancer with paclitaxel but does not disclose a combination with the specific compounds in the instant claims.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application includes evidence that compounds SBFI-102 and SBFI-103 can exhibit a synergistic effect when administered with docetaxel or cabazitaxel, according to the combination-index (CI) method published in Chou. (Spec., pp. 51–56; Ex. 1, 2).
The question of obviousness
Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Ojima-354, Ojima-276, Lengyel, Liu, and Hou to arrive at the claimed method and pharmaceutical composition.
Ojima-354 discloses the claimed compounds and discloses they are FABP inhibitors, and therefore useful for the treatment of FABP-related diseases. Ojima-276 and Liu disclose structurally-related compounds and Lengyel discloses other FABP inhibitors that are useful for the treatment of cancer. Ojima-276 teaches the structurally-related compounds can be co-administered with an anticancer therapy. And Hou teaches that combination therapy has been in widespread use for the treatment of cancer and paclitaxel specifically is good for such combination therapy.
Accordingly, one of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of the cited references because they are directed to the same or similar subject matter (i.e., structurally-related compounds used to treat diseases by inhibiting FABP). One of skill in the art would have been motivated to combine the teachings of the cited references for the purpose of developing new methods of treating cancer in a subject. As noted in Hou, combination therapy for the treatment of cancer is well established.
The evidence in the specification has been considered. The examples, however, are not commensurate in scope with the generic recitation of “anticancer therapy.” Moreover, Ojima-276 specifically discloses combining a structurally-related FABP inhibitor with additional antitumor agents and Hou suggests that paclitaxel (PTX) is used in combination with other anticancer agents. Thus, success using the disclosed combination would not have been unexpected to one of ordinary skill in the art at the time of filing the application.
Response to Arguments
Applicant’s arguments in the Reply have been fully considered. (Remarks, pp.11–17).
The first argument focuses on Liu. Applicant identifies structural differences between the compounds in Liu and the claimed compounds, and then compares cytotoxic data between two compounds in the instant application and the compounds in Liu. (Id., pp.13–14). Based on those points, Applicant asserts it would have been unreasonable to conclude the claimed compounds would exhibit inhibitory activity against human prostate cancer cell line based on Liu. (Id.).
This argument is not persuasive. The compounds in the instant claims are known FABP inhibitors—they were previously disclosed in Ojima-354. Applicant does not dispute that. Thus, Liu is not the closest prior art. The comparison between the compounds in Liu and the claimed compounds is therefore less relevant than whether it would have been obvious to modify Ojima-354 to obtain a composition further comprising a taxane and/or to use that composition in a method of treating prostate cancer. To that end, Ojima-276 discloses a combination therapy comprising structurally related FABP inhibitors and an anticancer agent, and a method of treating cancer. Lengyel and Liu disclose FABP inhibitors used to treat prostate cancer in combination with other agents. Hou discloses combination cancer therapy with paclitaxel.
The second argument focuses on Ojima-276 and Hou. Applicant argues that neither reference discloses the claimed compounds. (Remarks, p.15). Applicant further argues the references do not disclose a combination of such compounds and a taxane. (Id.).
This argument is not persuasive. Ojima-276 and Hou were not relied on for disclosing the claimed compounds in combination with a taxane. Nevertheless, Applicant does not dispute the compounds in Ojima-276 are FABP inhibitors that are structurally related to the claimed compounds. Applicant focuses on specific species in Ojima-276, but does not acknowledge one or more of the R3, R7, R8, and R12 substituents on the general formula can be -OR15. Thus, the instantly claimed compounds are encompassed by Ojima-276. And while Ojima-276 and Hou do not disclose the specifically claimed combination, they suggest using the FABP inhibitors therein in combination with an anticancer agent to treat cancer.
In addition, Applicant argues: “The presence of a property not possessed by the prior art is evidence of nonobviousness.” (Id., citing caselaw). This argument is not persuasive because the claimed FABP inhibitors are known in the prior art and therefore possess the same properties that they have always possessed. And while the claims are directed to a combination of the FABP inhibitors and a taxane, it should be noted that taxanes are well-known anticancer agents and combination therapies including a taxane are well-known in the prior art as a method of improving therapeutic results.
Double Patenting
(i) Claims 1, 2, 4, 10, 11, 13, 15, 19, 21, 22, 29, 30, 33, 34, 38, and 47–52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Pat. No. 11,026,910 (reference claim) in view of Ojima-276, Lengyel, Liu, and Hou.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a method of treating cancer comprising administering a FABP5 inhibitor to a subject, and the reference claim is directed to a method of inhibiting FABP comprising contacting the FABP with a compound in claim 1, whereby the compounds of reference claim 1 overlap within the compounds in the instant claims. The features of the instant claims not disclosed in the reference claim are disclosed in Ojima-276, Lengyel, Liu, and Hou—referred to in the obviousness rejection above and incorporated by reference herein. One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of the cited references with the reference claim because they are directed to overlapping subject matter (i.e., structurally-related compounds used to treat diseases by inhibiting FABP). One of skill in the art would have been motivated to combine the teachings of the cited references for the purpose of developing new methods of treating cancer in a subject. As noted in Hou, combination therapy for the treatment of cancer is well established. As such, an infringer of a patent granted based on the claims of one of the instant application or the reference claim would also be an infringer of the other.
(ii) Claims 1, 2, 4, 10, 11, 13, 15, 19, 21, 22, 29, 30, 33, 34, 38, and 47–52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 16 of U.S. Pat. No. 9,604,904 (reference claims) in view of Ojima-276, Lengyel, Liu, and Hou.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a method of treating cancer comprising administering a FABP5 inhibitor to a subject, and the reference claims are directed to a method of inhibiting the activity of a FABP comprising contacting the FABP with a compound in claim 1 or 6, whereby the compounds of reference claims 1 and 6 overlap within the compounds in the instant claims. The features of the instant claims not disclosed in the reference claims are disclosed in Ojima-276, Lengyel, Liu, and Hou—referred to in the obviousness rejection above and incorporated by reference herein. One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of the cited references with the reference claims because they are directed to overlapping subject matter (i.e., structurally-related compounds used to treat diseases by inhibiting FABP). One of skill in the art would have been motivated to combine the teachings of the cited references for the purpose of developing new methods of treating cancer in a subject. Thus, an infringer of a patent granted based on the claims of one of the instant application or the reference claim would also be an infringer of the other.
(iii) Claims 1, 2, 4, 10, 11, 13, 15, 19, 21, 22, 29, 30, 33, 34, 38, and 47–52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–14 of U.S. Pat. No. 10,213,406 (reference claims) in view of Ojima-276, Lengyel, Liu, and Hou.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a method of treating cancer comprising administering a FABP5 inhibitor to a subject, and the reference claims are directed to a method of inhibiting the activity of a FABP comprising contacting the FABP with a compound, whereby the compounds in the reference claims overlap within the compounds in the instant claims. The features of the instant claims not disclosed in the reference claims are disclosed in Ojima-276, Lengyel, Liu, and Hou—referred to in the obviousness rejection above and incorporated by reference herein. One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of the cited references with the reference claims because they are directed to overlapping subject matter (i.e., structurally-related compounds used to treat diseases by inhibiting FABP). One of skill in the art would have been motivated to combine the teachings of the cited references for the purpose of developing new methods of treating cancer in a subject. Thus, an infringer of a patent granted based on the claims of one of the instant application or the reference claim would also be an infringer of the other.
(iv) Claims 1, 2, 4, 10, 11, 13, 15, 19, 21, 22, 29, 30, 33, 34, 38, and 47–52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47, 55, and 57 of copending Application No. 18/248,232 (reference claims) in view of Ojima-276, Lengyel, Liu, and Hou.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a method of treating cancer comprising administering a FABP5 inhibitor to a subject, and the reference claims are directed to a method of inhibiting binding of a FABP to a FABP ligand comprising contacting the FABP with a compound, and a method of treating cancer with a compound; whereby the compounds in the reference claims overlap within the compounds in the instant claims. The features of the instant claims not disclosed in the reference claims are disclosed in Ojima-276, Lengyel, Liu, and Hou—referred to in the obviousness rejection above and incorporated by reference herein. One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of the cited references with the reference claims because they are directed to overlapping subject matter (i.e., structurally-related compounds used to treat diseases by inhibiting FABP). One of skill in the art would have been motivated to combine the teachings of the cited references for the purpose of developing new methods of treating cancer in a subject. Thus, an infringer of a patent granted based on the claims of one of the instant application or the reference claim would also be an infringer of the other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(v) Claims 1, 2, 4, 10, 11, 13, 15, 19, 21, 22, 29, 30, 33, 34, 38, and 47–52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39 and 40 of copending Application No. 18/346,363 (reference claims) in view of Ojima-276, Lengyel, Liu, and Hou.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to a method of treating cancer comprising administering a FABP5 inhibitor to a subject, and the reference claims are directed to a method of inhibiting the activity of a FABP comprising contacting the FABP with a compound, whereby the compounds in the reference claims overlap within the compounds in the instant claims. The features of the instant claims not disclosed in the reference claims are disclosed in Ojima-276, Lengyel, Liu, and Hou—referred to in the obviousness rejection above and incorporated by reference herein. One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of the cited references with the reference claims because they are directed to overlapping subject matter (i.e., structurally-related compounds used to treat diseases by inhibiting FABP). One of skill in the art would have been motivated to combine the teachings of the cited references for the purpose of developing new methods of treating cancer in a subject. Thus, an infringer of a patent granted based on the claims of one of the instant application or the reference claim would also be an infringer of the other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
No substantive arguments are presented. Applicant requests the double patenting rejections be held in abeyance until the claims are otherwise allowable. (Remarks, p.16).
Conclusion
No claims are allowed.
Communication
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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