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 .
DETAILED ACTION
1. Claims 1-23 are pending in the current application.
2. This application is a 371 of PCT/JP2021/027316 07/21/2021. FOREIGN APPLICATIONS: JAPAN 2020-125822 07/22/2020
Response to Restriction Election
3. Applicant’s election of the species, 2-(4-Cyclopropyl-2-fluoroanilino)-3,4-difluoro-5-[[3-fluoro-2-(methylsulfamoylamino)pyridin-4-yl]methyl]benzamide, in the reply filed on September 5, 2025 is acknowledged. The election was made without traverse. According to applicants’ representative all pending claims 1-23 read on the elected species.
Information Disclosure Statement
4. The Information Disclosure Statement of August 13, 2024 cites an unpublished US application. As explained in MPEP 609.04(a) II (C) “For each cited pending unpublished U.S. application, the application specification including the claims, and any drawings of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system. The requirement in 37 CFR 1.98(a)(2)(iii) for a legible copy of the specification, including the claims, and drawings of each cited pending U.S. patent application (or portion of the application which caused it to be listed) is sua sponte waived where the cited pending application is stored in the USPTO’s IFW system. See Waiver of the Copy Requirement in 37 CFR 1.98 for Cited Pending U.S. Patent Applications, 1287 OG 163 (October 19, 2004);”. However as discussed further, “This waiver is limited to the specification, including the claims, and drawings in the U.S. application (or portion of the application). If material other than the specification, including the claims, and drawings in the file of a U.S. patent application is being cited in an IDS, the IDS must contain a legible copy of such material. See 37 CFR 1.98(a)(l)(rv).” It is unclear which portion of the copending application is being cited.
The IDS of February 15, 2025 cites a published US patent application by its application number. If applications are published they are appropriately cited as the USPGPub number.
Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claims 1-14, 16, 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 1, 6, 10, 16 have phrases in parenthesis, “(where the bonds denoted by *, **, and *** are bonded to -NH….)”, “(the C1-6 alkyl group being optionally substituted with a halogen atom, a hydroxy group or a C1-C6 alkoxy group), “(the C1-6 alkoxy group being optionally substituted with a hydroxy group)”, “(the C3-C6 cycloalkyl group being optionally substituted with a C1-6 alkyl group)”. It is unclear if the parenthetical phrase serves to limit the preceding group by narrowing it, is merely exemplary, or is serving some other purpose. As such these phrases render the claim indefinite because it is unclear whether the limitation(s) in the parenthetical phrase is part of the claimed invention. See MPEP § 2173.05(d).
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.
6. Claim(s) 1-7, 9-14, 16, 18-20, is/are rejected under 35 U.S.C. 103 as being unpatentable over Marlow US 20070112038 A1 AND Hartung, “Optimization of allosteric MEK inhibitors. Part 1: Venturing into underexplored SAR territories. “ Bioorganic & Medicinal Chemistry Letters, 2013, 23(8), 2384-2390. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determination of the scope and content of the prior art
(MPEP 2141.01)
Marlow teaches compounds that are analogs of the compounds of the instant case that have the same utility on pages 1-2. Formula I and V which bear the second A ring choice of the instant claims, i.e. (4) the piperidinone. Formula V has the *, **, *** configuration of the parenthetical phrase:
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Formula V corresponding to instant formula (1) is disclosed further on page 9 paragraph [0131]. X is defined as CR10 and R10 is equivalent to instant R9 at least where it is defined as hydrogen, halogen and alkyl. In Paragraph [0134] R9 is defined as “arylalkyl” which would include a benzyl group or “heteroarylalkyl” corresponding to the X1 and X2 containing ring as a phenyl or pyridine in the *** position. This group is said to be optionally substituted as follows:
wherein any of said alkyl, alkenyl, alkynyl, cycloalkyl, aryl, arylalkyl, heteroaryl, heteroarylalkyl, heterocyclyl and heterocyclylalkyl portions are optionally Substituted independently with one or more groups independently selected from oxo …. halogen, cyano, nitro, trifluoromethyl, difluoromethoxy, trifluoromethoxy, azido, -NR4SO2R6, -SO2NR3R4, C(O)R, C(O)OR, OC(O)R, NRC(O)OR, NRC(O)R, C(O)NR3R4, NRR, NRC(O)NR3R4, NRC(NCN)NR'R'', OR,….
The R8 group which corresponds to instant R4 is defined as hydrogen or halogen in the first two definitions and as C3-C10 cycloalkyl in line 15. Either R1 or R2 which are variably attached can be considered the same as instant R5 and R6 at least where they are defined as hydrogen, halogen, and alkyl. A number of compounds in the Formula V series were prepared on pages 72 – page 75 as Examples 178-187. As well as those in Tables 2-8 on pages 77ff. which are amides or Weinreb type amides with R3 as either H, alkyl or hydroxyalkyl, corresponding to the instant R3; R9 is a halogen, alkyl (Me, Et) and CN. The compounds in Table 8 on page 87 are typical
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There are no benzyl or pyridinyl-CH2-substituents at R9 disclosed under Formula V however in the context of Formula I there are a number of examples that have these groups:
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Compositions for treating various cancers are disclosed on page 24 ff at [0238]. Paragraph [0251] describes dispersants of claim 1:
A carrier may take a wide variety of forms depending on the form of preparation desired for administration, e.g., oral or parenteral. Examples of Suitable carriers include any and all solvents, dispersion media, adjuvants, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, Sweeteners, stabilizers (to promote long term storage), emulsifiers, binding agents, thickening agents, salts, preservatives, solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, flavoring agents, and miscellaneous materials such as buffers and absorbents that may be needed in order to prepare a particular therapeutic composition.
Paragraph [0252] describes both the tablets and capsules of claim 13: “The compositions of the invention may be in a form Suitable for oral use (for example as tablets, lozenges, hard or soft capsules…) “
Paragraph [0251] describes the method of claim 14 “To prepare the pharmaceutical compositions according to one embodiment of this invention, a therapeutically or prophylactically effective amount of a compound of Formula I-V or a pharmaceutically acceptable salt, solvate, metabolite or prodrug thereof (alone or together with an additional therapeutic agent) is intimately admixed with a pharmaceutically acceptable carrier according to conventional pharmaceutical compounding techniques to produce a dose.”
Paragraph [0253] describes bases including carbonates and the magnesium stearate of claim 7, “[0253] Suitable pharmaceutically-acceptable excipients for a tablet formulation include, for example, inert diluents such as lactose, sodium carbonate, calcium phosphate or calcium carbonate, granulating and disintegrating agents such as corn starch or algenic acid; lubricating agents such as magnesium stearate…”
Paragraph [0255] describes the dispersants of claims 2-3: “[0255] Aqueous suspensions generally contain the active ingredient in finely powdered form together with one or more Suspending agents, such as sodium carboxymethylcellulose. methylcellulose, hydroxypropylmethylcellulose, Sodium alginate, polyvinyl-pyrrolidone…”
Subsequent to the work of Marlow, Hartung and coworkers at Bayer HealthCare explored the SAR of substituents on the core ring bearing the carboxamide as discussed on page 2385. Starting from compound 1 significant further optimization to increase enzymatic and cell potency and to reduce brain penetration was undertaken. After testing a number of aryl groups with different substituents as shown in Table 3 on page 2388-2389, the highly optimized sulfamide derivatives. The discussion on pages 2386 ff explains the finding of the phenyl sulfamides as the optimal groups:
By systematically assessing substituents on the phenoxy side-chain (exemplary analogs 18–21) several inhibitors with low nanomolar enzymatic and A375 cell potency were identified, but the lM threshold in the HCT116 assay was still not conquered. A breakthrough was accomplished with the striking finding that—despite the methyl sulfonamide analog 22 being not more potent than comparable amide analogs—its higher homolog 23 did show a sub-lM IC50 in the HCT116 proliferation assay. Surrounding SAR exploration gave rise to sulfamide 25 which was our most potent analog so far (IC50 of 155 nM in the HCT116 proliferation assay) and was therefore profiled in more detail. Sulfamide 25 showed a moderate blood clearance in rats of 2.1 L/h/kg (1 mg/kg iv dose) with a half-life of 2.2 h and a moderate bioavailability of 55%. Compound 25 was found to be highly efficacious in vivo in a LOX carcinoma mice model employing doses of 1 and 2.5 mg/kg po once-daily (data not shown). In incubations with liver microsomes and hepatocytes, demethylation of the sulfamide moiety was identified as the only metabolic pathway of 25.
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Inspired by this metabolic profiling result and being aware that metabolites in certain cases possess superior PK and physicochemical properties than their parent compounds, we synthesized the mono-methylated sulfamide 27 and its unsubstituted congener 28….. Gratifyingly, demethylated analogs 27 and 28 were found to be at least as potent as the dimethylated parent compound 25. The unsubstituted sulfamide 28 inhibited A375 proliferation with a low nanomolar IC50 and was as potent as PD325901 in the HCT116 proliferation assay. Sulfamide 28 was found to be up to 10-fold more potent than AZD6244 in the latter assay as well as in other proliferation assays with non-B-Raf driven cell lines. For example, compound 28 inhibited proliferation of A549 cells with an IC50 value of 132 nM (PD325901 166 nM, AZD6244 1750 nM), LOVO cells with an IC50 value of 175 nM (PD325901 128 nM, AZD6244 2830 nM) and MIA PaCa-2 cells with an IC50 value of 23 nM (PD325901 17 nM, AZD6244 142 nM), respectively.
MEK inhibitor 28 showed low clearance in all investigated species (rat, mouse, dog; see Table 4 for rat data) with long half-lives (32 h in rat, 34 h in mice and 110 h in dogs) and moderate-to-high bioavailabilities. In summary, metabolism-inspired removal of two methyl groups—a strategy which may be coined pre-metabolization—improved metabolic stability while target potency was retained.
Although not a focus of our optimization strategy at that time, switching to the unsubstituted sulfamide motif also increased the lipophilicity efficiency (decrease of c logP by 0.8 units). This very promising in vitro pharmacological and in vivo PK profile translated well into high in vivo efficacy in various xenograft models. For example, a daily dose of 1 mg/kg po was sufficient for complete tumor growth inhibition in an A549 (K-Ras mutated NSCLC) xenograft study in nude mice (Fig. 4). 1 mg/kg of sulfamide 28 (dosed once-daily) was statistically significantly more efficacious than 3 mg/kg PD325901 (once-daily). Due to its long half-life, intermittent dosing schemes (for example 1 mg/kg dosed every second day) were as efficacious in the A549 xenograft setting as daily dosing schemes. Most notably, sulfamide 28 showed an exceptionally low brain/ plasma exposure ratio after iv dosing to mice (Table 4). Low brain penetration potential was confirmed by comparing pERK inhibition by Western blotting of A549 tumor tissue with brain lysates at the highly efficacious dose of 2 mg/kg po (data not shown). Whereas ERK phosphorylation in tumor tissue was almost completely blocked 6 h after dosing, no change in pERK1/2 was observed in brain lysates.
Having constantly profiled analogs from our series for its brain penetration behavior in mice, we tried to rationalize our findings by correlating brain/plasma exposure ratios qualitatively to TPSA values (as a measure for polarity-driven permeability limitations) and Pgp recognition (as one well known mechanism for preventing brain penetration by active efflux).17 We did not find any hint for Pgp-mediated efflux for sulfamide 28 or for close analogs with similarly limited brain/plasma exposure ratios. For example, sulfamide 28 retained its high pERK inhibitory potency in the Pgp-expressing cancer cell line HeLa-MaTu-ADR whereas AZD6244 experienced a dramatic decrease of pERK inhibitory potency in this cell line. Of note, we found that analogs from our series with a TPSA of 130– 140 Å2 possess low brain penetration potential in mice while retaining sufficient bioavailability after oral dosing.
Ascertainment of the difference between the prior art and the claims
Marlow did not exemplify a phenyl group with a sulfonamide and only made generic descriptions of such groups as -NR4SO2R6, which is the group of R1 as the second embodiment, -S(=O)2-R8. The first embodiment of R1 as -S(=O)2NH-R8 is not disclosed in Marlow.
Finding of prima facie obviousness
Rationale and Motivation
(MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to use analogs of those of Marlow to produce the instant invention. The experienced medicinal chemist, who would make the compounds, would be motivated to prepare these compounds on the expectation that such close analogs would have similar properties and upon the routine nature of such experimentation in the art of medicinal chemistry. Since the-NR4SO2R6, which is the group of R1 as the second embodiment, -S(=O)2-R8 was suggested little more than could be expected other than a compound with the same or similar properties.
Beyond Marlow, the detailed SAR on the compounds with a very similar core undertaken by the Hartung and the group at Bayer would motivate the artisan of ordinary skill to make the sulfamide in the first R1 embodiment since such compounds had complete tumor growth inhibition, were significantly more efficacious with an exceptionally low brain penetration. Since the prior art has the suggestion to prepare a MEK inhibitor compound having phenyl sulfamide on the benzamide core, and the artisan would have known how to synthesize such a compound, such that the structural and/or functional result could reasonably have been predicted, a prima facie case of obviousness exists.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
7. Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marlow US AND Hartung as applied to claims 1-7, 9-14, 16, 18-20, above, and further in view of Zhong, L., Zhu, X., Yu, B., & Su, W. “Influence of alkalizers on dissolution properties of telmisartan in solid dispersions prepared by cogrinding.” Drug Development and Industrial Pharmacy, 2013, 40(12), 1660–1669. As discussed above Marlow describes various excipients as dispersants and bases to the compositions of the compounds, however meglumine is not disclosed. According to Zhong mixing meglumine with dispersants can improved solubility and other properties. “In order to improve its poor solubility, several approaches have been reported, such as incorporating alkalizers into TEL solid dispersions (SDs)1, being loaded with nanoparticles 2,3 or preparation of amorphous form4. Although a definite progress has achieved in previous research, there are still some aspects to be improved. In the present work, immediate-release solid dispersion systems of TEL were prepared by employing the mechanical mill. Mechanical treatment is environmentally friendly. Unlike other techniques, it does not require toxic solvents (whose removal would be difficult and expensive) and sophisticated equipment, with the advantage of relatively simple processes and a decrease in the total time5,6. On the other hand, this approach is usually effective in increasing the solubility of insoluble drugs 7–10. With the purpose of improving the dissolution properties of TEL, several alkalizers were mixed in solid systems containing TEL and PVP k30 , respectively. After milling, the result will be a change of microenvironmental pH (pH M) nearby drug particles or salt formation between drug and alkalizers.” [page 1660].
“Five alkalizers in this study were MgO, Na2CO3, K2CO3, NaHCO3 and meglumine. In soft mode using a roll mill, the drug could not form salt with MgO or NaHCO3, whereas partial drug had been transformed into salt with carbonates or meglumine. Under cogrinding, the organic base meglumine was easier to react with telmisartan than other two carbonates…” (abstract).
It would be obvious to formulate the compositions of Marlow with meglumine since it would be expected to improve solubility.
8. Claims 1-6, 9-21, is/are rejected under 35 U.S.C. 103 as being obvious over Isshiki WO 2021149776 A1 (cited on the IDS, English equivalent is US 11,964,950).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Isshiki teaches the genus of the instant claims at col. 5 lines 1 ff. The elected species is disclosed at col. 94 lines 10ff as compound A-1.
Co. 44 lines 21-33 describe the excipients of claim 2, “Examples of excipients include starches (starch, potato starch, cornstarch, etc.), lactose, crystalline cellulose, and calcium hydrogen phosphate. Examples of lubricants (coating agents) include ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, shellac, talc, carnauba wax, and paraffin. Examples of binders include polyvinylpyrrolidone and macrogol, as well as the same compounds mentioned as excipients. Examples of disintegrants include chemically modified starches and celluloses such as croscarmellose sodium, carboxymethyl starch sodium and crosslinked polyvinylpyrrolidone, as well as the same compounds mentioned as excipients.”
Co. 44 lines 44 ff. describe the excipients of claim 3, “Examples of dispersants include cellulose derivatives (e.g., gum arabic, tragacanth, and methyl cellulose), polyester stearates, sorbitan sesquioleate, aluminum monostearate, sodium alginate, polysorbates, and sorbitan fatty acid esters.”
Col. 44 line 5 ff. describes the dosage form of claim 13, “A compound, salt or solvate of the present disclosure will usually be used in the form of a pharmaceutical formulation (dosage form). Examples of such formulations include tablets, capsules, granules, powders, fine granules, pills, and aqueous or nonaqueous solutions or suspensions.”
Regarding claim 15, since the compound was prepared by the process at col. 94 lines 30 ff. with the starting material of compound (X), by dissolving “5-[(2-amino-3-fluoropyridin-4-yl)methyl ]-2-( 4-cyclopropy 1-2-fluoroanilino )-3 ,4-difluoro benzamide”, there is an expectation of a small amount less than 3% in the product. The artisan could reduce this amount to whatever desired through conventional means. In the same procedure, the compound was purified by HPLC so at least HPLC could be used to purify the compound. “HPLC retention time: 1.13 min (analysis conditions A)”.
9. Claim(s) 7-8, 22-23, is/are rejected under 35 U.S.C. 103 as being unpatentable over Isshiki as applied to claims above, and further in view of Zhong, L., Zhu, X., Yu, B., & Su, W. “Influence of alkalizers on dissolution properties of telmisartan in solid dispersions prepared by cogrinding.” Drug Development and Industrial Pharmacy, 2013, 40(12), 1660–1669. As discussed above Ishikki describes various excipients as dispersants and bases to the compositions of the compounds, however meglumine is not disclosed. According to Zhong mixing meglumine with dispersants can improved solubility and other properties. For these reasons it would be obvious to add meglumine to the composition of Isshiki.
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 claims at issue 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(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 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 1-6, 9-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12-18, 20-22 of U.S. Patent No. 11,964,950. Although the claims at issue are not identical, they are not patentably distinct from each other because US ‘950 discloses the compounds of the instant claims where A is (2) including the elected species and compositions thereof. The elected species appears in claims 5-9, 12-13, 16-17, 20-21. Claims 10, 14, 18, 22 are composition claims thereof and according to the specification to the ‘950 those claimed compositions include the instantly claimed ingredients as discussed above in the 103 rejection.
11. Claims 7-8, 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12-18, 20-22 of U.S. Patent No. 11,964,950 as applied to claims 1-6, 9-21 above and further in view of Zhong, L., Zhu, X., Yu, B., & Su, W. “Influence of alkalizers on dissolution properties of telmisartan in solid dispersions prepared by cogrinding.” Drug Development and Industrial Pharmacy, 2013, 40(12), 1660–1669. As discussed above the ‘950 patent describes various compositions and excipients as dispersants and bases with the compounds, however meglumine is not disclosed. According to Zhong mixing meglumine with dispersants can improve solubility and other properties. For these reasons it would be obvious to add meglumine to the composition of Isshiki.
12. Claims 1-6, 9-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10 of copending Application No. 18/608,369. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘369 application is drawn to a method of treating with the claimed compounds. The method of treating involves administering the compounds, which in an embodiment involves the claimed compositions as disclosed on pages 75 ff. One could not practice the method without the claimed compositions. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010). As per MPEP 804 II. (B) (2) (a): “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).” In Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003), the earlier patent claimed a compound and the written description disclosed the utility of that compound. The later patent claimed nothing more than the earlier patent’s disclosed utility as a method of using the compound. Thus, the court found that the claims of the later patent and the claims of the earlier patent were not patentably distinct. The instant application is not related to the application and as such the safe harbor provision of 35 U.S.C 121 does not apply to this relationship.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. Claims 7-8, 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10 of copending Application No. 18/608,369. as applied to claims 1-6, 9-21 above and further in view of Zhong. As discussed above the ‘369 application describes administration with various compositions and excipients as dispersants and bases with the compounds, however meglumine is not disclosed. According to Zhong mixing meglumine with dispersants can improve solubility and other properties. For these reasons it would be obvious to add meglumine to the composition of Isshiki.
Conclusion
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID K O'DELL/Primary Examiner, Art Unit 1621