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 .
Status of the Claims
Claims 1 and 48 – 63 are pending.
Claims 50 – 52 are rejected.
Claims 1, 48 – 49 and 53 – 63 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 50 – 52, 55 – 57 and 61 – 63, in the reply filed on April 1, 2026 is acknowledged. Applicant further specifically elected the compound ERX1168 and obesity as the single obesity-related disease or disorder to be treated. The compound ERX1168 is presented below:
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The compound ERX1168 reads on the structure of Formula (I):
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, wherein:
R1 is –NHCOR5, wherein R5 is C1 alkyl (methyl);
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Examination: Applicant’s elected species reads on claims 50 – 52. The elected species of the compound ERX1168 and obesity as the single obesity-related disease or disorder are not allowable. Claims 50 – 52 would be rejected under nonstatutory double patenting rejection as being unpatentable over claims 1 – 7 and 16 – 18 of U.S. Patent 10,662,218 B2, and claims 1 and 9 – 11 of U.S. Patent 11,753,436 B2. However, in the interest of compact prosecution, examination of the Markush-type claim has been extended to include the compound of Formula (I), wherein:
R1 is –CH2OH, –CH2OR5, –CH2NR5R5, –CH2NR5CONR5R5, –CH2NHCOR5 or –CH2–morpholino ring (last structure);
R2 is hydrogen or -SR5,
R5 is –COR5, or –CONR5R5; and
R5 is selected from hydrogen, alkyl, alkoxy, heterocycloalkyl, amine; or two R5 taken together form a optionally substituted heterocycloalkyl.
Examination of the Markush-type claim has also been extended to include diabetes as the obesity-related disease or disorder.
Pursuant to Federal Register, Vol. 76, No. 27, dated February 9, 2011, page 7166 (middle column):
“Under principles of compact prosecution, the examiner should also require the applicant to elect a species or group of indistinct species for search and examination (i.e., an election of species). If the examiner does not find the species or group of indistinct species in the prior art, then the examiner should extend the search to those additional species that fall within the scope of a permissible Markush claim. In other words, the examiner should extend the search to the species that share a single structural similarity and a common use. The improper Markush claim should be examined for patentability over the prior art with respect to the elected species or group of indistinct species…within the scope of a proper Markush claim.”
Subject matter not embraced by the elected embodiment or the scope searched is therefore withdrawn from further consideration. Claims 1, 48 – 49 and 53 – 63 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a nonelected invention/ compound and disease species, there being no allowable generic or linking claim.
Priority
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Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 17, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 50 – 52 are objected to because of the following informalities:
Claims 50 – 51 are directed to a method of treating obesity or obesity-related disease or disorder in a subject in need thereof comprising administering to the subject an effective amount of a compound of claim 48. Said claims refer to a compound of withdrawn claim 48, which is ultimately dependent on withdrawn claim 1. Claim 52 is dependent and does not cure the deficiencies in claim 51. In order to overcome the objection, Applicant may amend the claims to incorporate all limitations from independent claim 1 and claim 48 into the body of claims 50 and 51.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 51 – 52 are rejected under 35 U.S.C 102(a)(1)/ 102(a)(2) as being unpatentable over Qian et al. WO 2012/024893 A1, as disclosed in IDS dated July 17, 2023.
Qian et al. teaches compounds of Examples 1 – 10 and the pharmaceutical composition comprising said compound and a pharmaceutically acceptable excipient. See, e.g., paragraphs [001] – [021], [077] – [089], [0102] – [0117], Examples 1 – 11). The compounds of Examples 1 – 10 are presented below:
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wherein:
R1 is –CH2OH, –CH2OR5, –CH2NR5R5, –CH2NR5CONR5R5, –CH2NHCOR5 or –CH2–morpholino ring (last structure in instant variable R1), wherein R5 is selected from hydrogen, alkyl, alkoxy, heterocycloalkyl (morpholinyl, pyrrolindinyl or piperazinyl), amine; or two R5 taken together form a heterocycloalkyl (morpholinyl, pyrrolindinyl or piperazinyl) optionally substituted with alkyl;
R2 is hydrogen;
R4 is –OH,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Qian et al. also teach the compounds can be used in treating several diseases or disorders, including diabetes mellitus. See, e.g., paragraph [014]. Qian also teaches that the pharmaceutical composition can be administered orally or intraperitoneally.
The prior art would have anticipated the instant claims as presented below:
Claims 51 – 52, directed to a method of treating diabetes comprising administering to a subject suffering from or at risk of suffering from diabetes a pharmaceutical composition comprising a compound of Formula (I):
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, wherein:
R1 is –CH2OH, –CH2OR5, –CH2NR5R5, –CH2NR5CONR5R5, –CH2NHCOR5 or –CH2–morpholino ring (last structure in instant variable R1), wherein R5 is selected from hydrogen, alkyl, alkoxy, heterocycloalkyl (morpholinyl, pyrrolindinyl or piperazinyl), amine; or two R5 taken together form a heterocycloalkyl (morpholinyl, pyrrolindinyl or piperazinyl) optionally substituted with alkyl;
R2 is hydrogen;
R4 is –OH,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
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 50 – 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 7 and 16 – 18 of U.S. Patent 10,662,218 B2, as disclosed in IDS dated July 17, 2023. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘218 claims a compound of Formula (I):
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Claim 7 specifically recites the compound ERX-1168 as presented below:
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Claims 16 – 17 specifically recite the methods:
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The claims in US ‘218 render the instant claims unpatentable for anticipatory-type double patenting as presented below:
Claim 50, directed to a method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of a compound of Formula (I):
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, wherein:
R1 is –NHCOR5, wherein R5 is C1 alkyl (methyl);
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 51 – 52, directed to a method of treating obesity comprising administering to a subject suffering from or at risk of suffering from obesity a pharmaceutical composition comprising a compound of Formula (I):
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, wherein:
R1 is –NHCOR5, wherein R5 is C1 alkyl (methyl);
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 50 – 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 14 of U.S. Patent 11,753,436 B2, as disclosed in IDS dated July 17, 2023. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘436 claims a compound of Formula (I):
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Claim 9 specifically claims a compound of Formula (II):
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With respect to the instant claims, the claims in US ‘436 do not specifically recite the method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of a compound of Formula (I). The conflicting claims in US ‘436 are directed to a different statutory class of invention (method of using the compounds of Formula (I) rather than the compounds of Formula (I)). The Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. `
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
See also section 804 IIb of the M.P.E.P.
In the instant case, the specification in US ‘436 identifies the utility of the compound of Formula (I) to treat obesity in a subject in need thereof comprising administering the composition comprising an effective amount of the compound. See, e.g., column 8, lines 7-11. The specification also defines:
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. See, e.g., column 8, line 12-22. Since said utility of the compound as claimed in US ‘436 is identical to the utility claimed in the instant claims, the claims in US ‘436 render the instant claims 50 – 52 unpatentable for obviousness-type double patenting as presented below:
Claim 50, directed to a method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of a compound of Formula (I):
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, wherein:
R1 is –NHCOR5, wherein R5 is C1 alkyl (methyl);
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 51 – 52, directed to a method of treating obesity comprising administering to a subject suffering from or at risk of suffering from diabetes a pharmaceutical composition comprising a compound of Formula (I):
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, wherein:
R1 is –NHCOR5, wherein R5 is C1 alkyl (methyl);
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 50 – 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2 of U.S. Patent 9,968,575 B2, as disclosed in IDS dated July 17, 2023. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘575 claims an anti-obesity dosage formulation:
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With respect to the instant claims, the claims in US ‘575 do not specifically recite the method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of the compound. The conflicting claims in US ‘575 are directed to a different statutory class of invention (method of using the compounds of Formula (I) rather than the compounds of Formula (I)). The Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. `
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
See also section 804 IIb of the M.P.E.P.
In the instant case, the specification in US ‘575 identifies the utility of the compound to induce weight loss in a pre-obese, obese, or morbidly obese patient comprising administering the composition comprising an effective amount of the compound. See, e.g., column 50, lines 22-38.
Since said utility of the compound as claimed in US ‘575 is identical to the utility claimed in the instant claims, the claims in US ‘575 render the instant claims 50 – 52 unpatentable for obviousness-type double patenting as presented below:
Claim 50, directed to a method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 51 – 52, directed to a method of treating obesity comprising administering to a subject suffering from or at risk of suffering from diabetes a pharmaceutical composition comprising a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 50 – 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3 of U.S. Patent 9,925,161 B2, as disclosed in IDS dated July 17, 2023. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1 – 3 in US ‘161 claims a method:
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The claims in US ‘218 render the instant claims unpatentable for anticipatory-type double patenting as presented below:
Claim 50, directed to a method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 51 – 52, directed to a method of treating obesity comprising administering to a subject suffering from or at risk of suffering from obesity a pharmaceutical composition comprising a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 50 – 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 12 of U.S. Patent 10,653,654 B2, disclosed in IDS dated July 17, 2023. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘654 claims a pharmaceutical dosage formulation for administration to a pre-obsese, obese, or morbidly obese human comprising a compound.
Claim 11 specifically claim the compound:
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With respect to the instant claims, the claims in US ‘654 do not specifically recite the method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of the compound. The conflicting claims in US ‘654 are directed to a different statutory class of invention (method of using the composition comprising the compounds rather than the composition comprising the compound). The Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. `
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
See also section 804 IIb of the M.P.E.P.
In the instant case, the specification in US ‘575 identifies the utility of the composition:
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. See, e.g., column 50, lines 22-38.
Since said utility of the compound as claimed in US ‘654 is identical to the utility claimed in the instant claims, the claims in US ‘654 render the instant claims 50 – 52 unpatentable for obviousness-type double patenting as presented below:
Claim 50, directed to a method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is -SR5, wherein R5 is C2 alkyl substituted with hydroxyl;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 51 – 52, directed to a method of treating obesity comprising administering to a subject suffering from or at risk of suffering from diabetes a pharmaceutical composition comprising a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is -SR5, wherein R5 is C2 alkyl substituted with hydroxyl;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 50 – 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2 and 8 of U.S. Patent 11,045,439 B2, as disclosed in IDS dated July 17, 2023. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘439 claims a pharmaceutical dosage formulation:
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With respect to the instant claims, the claims in US ‘439 do not specifically recite the method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of the compound. The conflicting claims in US ‘439 are directed to a different statutory class of invention (method of using the compounds of Formula (I) rather than the compounds of Formula (I)). The Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. `
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
See also section 804 IIb of the M.P.E.P.
In the instant case, the specification in US ‘439 identifies the utility of the compound:
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. See, e.g., column 52, lines 41-46.
Since said utility of the compound as claimed in US ‘439 is identical to the utility claimed in the instant claims, the claims in US ‘439 render the instant claims 50 – 52 unpatentable for obviousness-type double patenting as presented below:
Claim 50, directed to a method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 51 – 52, directed to a method of treating obesity comprising administering to a subject suffering from or at risk of suffering from diabetes a pharmaceutical composition comprising a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 50 – 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 – 5 of U.S. Patent 12,064,408 B2, as disclosed in IDS dated July 17, 2023. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘408 claims a pharmaceutical dosage formulation:
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With respect to the instant claims, the claims in US ‘408 do not specifically recite the method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of the compound. The conflicting claims in US ‘408 are directed to a different statutory class of invention (method of using the compound rather than the compound). The Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. `
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
See also section 804 IIb of the M.P.E.P.
In the instant case, the specification in US ‘408 identifies the utility of the compound:
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344
412
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. See, e.g., column 51, lines 39-55.
Since said utility of the compound as claimed in US ‘408 is identical to the utility claimed in the instant claims, the claims in US ‘408 render the instant claims 50 – 52 unpatentable for obviousness-type double patenting as presented below:
Claim 50, directed to a method of treating obesity in a subject in need thereof comprising administering to the subject an effective amount of a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Claims 51 – 52, directed to a method of treating obesity comprising administering to a subject suffering from or at risk of suffering from diabetes a pharmaceutical composition comprising a compound of Formula (I):
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, wherein:
R1 is –COOH;
R2 is hydrogen;
R4 is –OR7, wherein R7 is H,
R3 is =O when R4 is O and a double bond is present between C2 and R3, and C3 and C4.
Conclusion
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626