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 . Claims 1-3, 5-10, 12-16, 24, 26, 31-35 filed November 06, 2025 are currently pending. Claim 1 is independent.
Election/Restrictions
Applicant’s election without traverse of Group (I) claims 1-3, 5-10, 12-16, 24, 26, 31-34 in the reply filed on 11/06/2025 is acknowledged. Claim 35 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/06/2025.
Secondly, Applicant’s election without traverse of
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as the species of Formula (I) and sulfobutyl ether-beta-cyclodextrin in the reply filed on 11/06/2025 is acknowledged. Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of alkylated cyclodextrin there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/06/2025.
Priority
Acknowledgement is made of the national stage entry of PCT/US2021/056322 filed 10/22/2021 which claims priority to U.S. Provisional Application 63106297 filed 10/23/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/28/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-2, 9-10, 12-13, 15-16, 24-26 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Mourot (ACS Chemical Neuroscience Vol. 2 pages 536-543 published 2011), Van Gelder (WO2020/191292 published 09/24/2020 with priority to U.S. Provisional Application 62821044 filed 03/20/2019), Zhang (U.S. Patent 10,189,955 published 01/29/2019) and Bortolus (J. Phys. Chem Vol. 91 pages 5046-5050 published 1987).
Mourot (ACS Chemical Neuroscience Vol. 2 pages 536-543 published 2011) teaches azobenzene compounds of Formula (I) as tunable photochromic ion channel blockers (abstract, page 536 right col., Figure 1). As evidenced by Figure 1 of Mourot, the compound BENAQ reads on the structural limitations of Formula (I) as follows: R1 is NR10R11, wherein R10 is a C1-C10 alkyl and R11 is a substituted C1 alkyl, R2 is H R3-R5 are each independently ethyl, R6 is H. Mourot teaches that said azobenzenes are thermally unstable in the cis form and revert at room temperature back to the thermodynamically stable trans form on millisecond to second time scale (page 538 left col). Mourot teaches that the claimed azobenzene compounds comprise low aqueous solubility in buffered solutions, which makes it difficult to deliver the compounds to the targeted tissue (page 541 left col.).
The difference between the presently claimed composition and that of Mourot is that Mourot does not specifically teach formulating the azobenzene compound BENAQ with a cyclodextrin, wherein the cyclodextrin is an alkylated cyclodextrin. Nor does Mourot specifically teach wherein the molar ratio between the compound of Formula (I) and the alkylated cyclodextrin is from 1:1 to 500:1.
Van Gelder (WO2020/191292 published 09/24/2020 with priority to U.S. Provisional Application 62821044 filed 03/20/2019) teaches an aqueous pharmaceutical composition comprising the azobenzene compound BENAQ (100 mM) formulated in a solution comprising 10% cyclodextrin ([0075]). As evidenced by CAS Registry Database, the compound BENAQ reads on the structural limitations of Formula (I) as follows: R1 is NR10R11, wherein R10 is a C1-C10 alkyl and R11 is a substituted C1 alkyl, R2 is H R3-R5 are each independently ethyl, R6 is H.
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to formulate the compound of Formula (I), art-recognized as comprising poor aqueous solubility with a cyclodextrin in view of Van Gelder.
MPEP 2143 provides rationale for a conclusion of obviousness including: (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, it was known in the prior art of Van Gelder to prepare solutions comprising the compound of Formula (I) BENAQ in a composition comprising 10% cyclodextrin. Accordingly, said artisan would have applied the teachings of Van Gelder to the azobenzene compounds comprise low aqueous solubility in buffer solutions taught by Mourot, arriving at the presently claimed.
The difference between the presently claimed composition and that of Mourot and Van Gelder is that the combination of Mourot and Van Gelder does not specifically teach formulating the azobenzene compound BENAQ with a cyclodextrin, wherein the cyclodextrin is an alkylated cyclodextrin. Nor does the combination of Mourot and Van Gelder specifically teach wherein the molar ratio between the compound of Formula (I) and the alkylated cyclodextrin is from 1:1 to 1:500.
Zhang (U.S. Patent 10,189,955 published 01/29/2019) teaches host: guest inclusion complexes of azobenzene compounds with cyclodextrins as suitable delivery vehicles. Zhang teaches that azobenzene compounds are art-recognized as being hydrophobic, electron-rich and the appropriate size makes it a suitable guest for cyclodextrins (col. 23 lines 25-40, col. 37 line 40 to col. 38 lines 20, col. 75 line 60 to col. 77 line 30). Alpha, beta and gamma cyclodextrins are taught which comprise either 4, 5 or 6 D-glucopyranose units which reads on the limitation of claim 2. Utilization of alkylated cyclodextrins wherein one or two primary hydroxyl groups of the cyclodextrin is functionalized with alkylamine containing substituents is taught by Zhang (col. 37 line 40 to col. 38 lines 20).
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Zhang teaches that when the cyclodextrin-azobenzene inclusion complex is irradiated with UV light, the trans-azobenzene compound is isomerized to the cis isomer, which is too bulky to be accommodated in the cavity of the cyclodextrin. The spatial change disrupts the host:guest complex and the complex degrades and the encapsulated content is released (col. 75 line 60 to col. 77 line 30, Figures 13-14).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to formulate the art-recognized azobenzene compounds comprising low aqueous solubility of Formula (I) or Mourot and Van Gelder, in a cyclodextrin, wherein the cyclodextrin is an alkylated cyclodextrin in view of Zhang.
MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, Zhang teaches that azobenzene compounds are art-recognized as being hydrophobic, electron-rich and the appropriate size makes it a suitable guest for cyclodextrins. Zhang teaches that utilization of alkylated cyclodextrins wherein one or two primary hydroxyl groups of the cyclodextrin is functionalized with alkylamine containing substituents is suitable for said host: guest inclusion complexes with azobenzene compounds (col. 23 lines 25-40, col. 37 line 40 to col. 38 lines 20, col. 75 line 60 to col. 77 line 30). Accordingly, said artisan would have applied the teachings of Zhang to the composition comprising cyclodextrin and art-recognized azobenzene compounds of Formula (I) comprising low aqueous solubility of Mourot and Van Gelder, arriving at the presently claimed composition.
However, the combination of Mourot, Van Gelder and Zhang do not specifically teach wherein the molar ration between the azobenzene compound and alkylated cyclodextrin is between 1:1 to 500:1.
Bortolus (J. Phys. Chem Vol. 91 pages 5046-5050 published 1987) teaches preparing compositions comprising azobenzene and cyclodextrins as host:guest inclusion complexes (abstract, page 5046 left-right col). Bortolus teaches wherein the molar ratio of cyclodextrin to azobenzene is 10:1 (Figure 2, page 5047 right col.). Bortolus teaches that the inclusion complexes of trans-azobenzene with alpha and beta-cyclodextrins have similar structures wherein the azo dye is included axially in the cavity of the cyclodextrin (page 5048 left col.).
Therefore, one of ordinary skill in the art of formulating art-recognized azobenzene compounds comprising low aqueous solubility of Formula (I) in an alkylated cyclodextrin as taught by the combination of Mourot, Van Gelder and Zhang, said skilled artisan would have found it prima facie obvious to prepare said cyclodextrin and azobenzene compound formulation wherein the molar ratio of cyclodextrin to azobenzene is 10:1 as taught by Bortolus.
MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, considering it was known in the art of Bortolus to prepare cyclodextrin and azobenzene compound formulation wherein the molar ratio of cyclodextrin to azobenzene is 10:1, consistent with this reasoning, it would have been obvious to have selected the 10:1 cyclodextrin: azobenzene molar ratio of Bortolus and apply it to the composition comprising the art-recognized azobenzene compound comprising low aqueous solubility of Formula (I) formulated in an alkylated cyclodextrin of Mourot, Van Gelder and Zhang above, arriving at the claimed composition yielding no more than one would expect from such an arrangement.
Regarding the limitation of claims 13 and 15, Van Gelder teaches formulating the azobenzene compound BENAQ with a cyclodextrin wherein BENAQ is present in a concentration of (100 mM) ([0075]).
Regarding the limitation of claims 16, 24 and 26, wherein the azo bond is greater than 50% of the molecules of Formula (I) in the composition is trans, or greater than 90% of the molecules are complexed with the cyclodextrin, as taught by Zhang above, when the cyclodextrin-azobenzene inclusion complex is irradiated with UV light, the trans-azobenzene compound is isomerized to the cis isomer, which is too bulky to be accommodated in the cavity of the cyclodextrin. The spatial change disrupts the host:guest complex and the complex degrades and the encapsulated content is released (col. 75 line 60 to col. 77 line 30, Figures 13-14). As such, the examiner has interpreted that the composition comprising azobenzene compounds of Formula (I) encapsulated in a cyclodextrin are oriented in the trans conformation about the azo bond.
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Finally, it is noted that the claimed product comprising the art-recognized low aqueous solubility azobenzene compounds of Formula (I) formulated in an alkylated cyclodextrin a ratio of 1:10 has been rendered obvious by the combined teaching of Mourot, Van Gelding, Zhang and Bortolus. Properties (such as ‘wherein greater than 90% of the molecules of Formula (I) in the composition are complexed with the cyclodextrin”) are considered characteristic features of the claimed product.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case the burden is shifted to Applicant to prove that the art-recognized low aqueous solubility azobenzene compounds of Formula (I) formulated in an alkylated cyclodextrin a ratio of 1:10 has been rendered obvious by the combined teaching of Mourot, Van Gelding, Zhang and Bortolus are not complexed with the cyclodextrin in a concentration of greater than 90%.
Claim(s) 3, 5, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Mourot (ACS Chemical Neuroscience Vol. 2 pages 536-543 published 2011), Van Gelder (WO2020/191292 published 09/24/2020 with priority to U.S. Provisional Application 62821044 filed 03/20/2019), Zhang (U.S. Patent 10,189,955 published 01/29/2019) and Bortolus (J. Phys. Chem Vol. 91 pages 5046-5050 published 1987) as applied to claims 1-2, 9-10, 12-13, 15-16, 24, 26 and 31-32 above, in view of Stella (U.S. Patent 6,046,177 published 04/04/2000).
As disclosed above, the combination of Mourot, Van Gelder, Zhang and Bortolus render obvious a pharmaceutical composition comprising the art-recognized low aqueous solubility azobenzene compounds of Formula (I) formulated in an alkylated cyclodextrin a ratio of 1:10, as it was known in the prior art to formulate said azobenzene compounds of Formula (I) in cyclodextrins, coupled with the knowledge that alkylated cyclodextrins are suitable for host:guest inclusion complexes with azobenzene compounds in a molar ratio of 1:10 compound: cyclodextrin as taught by Zhang and Bortolus.
The difference between the pharmaceutical composition embodied in the combined teachings of Moulton, Van Gelder, Zhang and Bortolus and that of the present claims is that the combination of Moulton, Van Gelder, Zhang and Bortolus does not specifically teach wherein the alkylated cyclodextrin comprises sulfoalkylether substituents.
Stella (U.S. Patent 6,046,177 published 04/04/2000) teaches sulfoalkyl ether beta cyclodextrins. Embraced within the sulfoalkyl ether beta-cyclodextrin include SBE7 wherein there are 7 sulfoalkyl ether substituents on the beta-cyclodextrin and 7-repeating glucopyranose units which reads on the substitution pattern of the cyclodextrin embodied in instant claims 2-3, 5, 7-8 (col. 4 lines 30-60, col. 10 lines 55-65).
Stella teaches complexation of a poorly water soluble therapeutic agent with the sulfoalkyl ether beta cyclodextrin in a host:guest inclusion complex wherein the therapeutic agent is encapsulated in the cavity of the cyclodextrin. Ratios of 1:1 to 1:20 of the therapeutic agent to sulfoalkylether beta-cyclodextrin are taught, though generally, the cyclodextrin will be in excess of the therapeutic agent, depending on the solubility of the therapeutic agent (col. 10 line 55 to col. 12 line 30). Stella teaches that said cyclodextrins increase the solubility of poorly water soluble drugs in varying degrees, which in turn enhances the bioavailability and rate of absorption of the therapeutic agent (col. 10, lines 55 to col 12 line 30, col. 22 lines 15-50).
Therefore, one of ordinary skill in the art prior to the time of the invention knowing that azobenzene compounds of Formula (I) taught by Moulton are art-recognized as comprising poor aqueous solubility and that it is known to formulate said compounds with a cyclodextrin as taught by Van Gelding, coupled with the knowledge that alkylated cyclodextrins are suitable for host:guest inclusion complexes with azobenzene compounds in a molar ratio of 1:10 compound: cyclodextrin as taught by Zhang and Bortolus, said skilled artisan would have found it prima facie obvious to substitute the alkylated cyclodextrin in the formulation of Moulton, Van Gelding, Zhang and Bortolus, for another alkylated cyclodextrin, such as a sulfoalkylether beta-cyclodextrin in view of Stella, arriving at the presently claimed composition.
MPEP 2143 provides rationale for a conclusion of obviousness including (B): Simple substitution of one known element for another to obtain predictable results;
In the present case, the azobenzene compounds of Formula (I) taught by Moulton are art-recognized as comprising poor aqueous solubility coupled with the knowledge that it is known to formulate said compounds with a cyclodextrin as taught by Van Gelding. Considering Stella teaches that sulfoalkyl ether beta-cyclodextrins including SBE7 wherein there are 7 sulfoalkyl ether substituents on the beta-cyclodextrin and 7-repeating glucopyranose units is efficacious at increasing the solubility of poorly water soluble drugs, said skilled artisan would have readily predicted that substitution of the alkylated cyclodextrin in the cyclodextrin: BENAQ formulation of Moulton, Van Gelding, Zhang and Bortolus for another alkylated cyclodextrin, such as SBE7 beta-cyclodextrin of Stella, the resulting cyclodextrin would have improved the aqueous solubility of the art-recognized poorly soluble compound of Formula (I).
Claim(s) 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Mourot (ACS Chemical Neuroscience Vol. 2 pages 536-543 published 2011), Van Gelder (WO2020/191292 published 09/24/2020 with priority to U.S. Provisional Application 62821044 filed 03/20/2019), Zhang (U.S. Patent 10,189,955 published 01/29/2019) and Bortolus (J. Phys. Chem Vol. 91 pages 5046-5050 published 1987). as applied to claims 1-2, 9-10, 12-13, 15-16, 24, 26 and 31-32 above in view of Trauner (WO2010/051343 published 05/06/2010).
As disclosed above, the combination of Mourot, Van Gelder, Zhang and Bortolus render obvious a pharmaceutical composition comprising the art-recognized low aqueous solubility azobenzene compounds of Formula (I) formulated in an alkylated cyclodextrin a ratio of 1:10, as it was known in the prior art to formulate said azobenzene compounds of Formula (I) in cyclodextrins, coupled with the knowledge that alkylated cyclodextrins are suitable for host:guest inclusion complexes with azobenzene compounds in a molar ratio of 1:10 compound: cyclodextrin as taught by Zhang and Bortolus.
The difference between the pharmaceutical composition embodied in the combined teachings of Moulton, Van Gelder, Zhang and Bortolus and that of the present claims is that the combination of Moulton, Van Gelder, Zhang and Bortolus does not specifically teach wherein the composition is an aqueous solution with an osmolality between 250-350 mOsm, nor specifically teach said composition is a solid suitable for reconstitution.
Trauner (WO2010/051343 published 05/06/2010) teaches azobenzene compounds of Formula (I) including the claimed BENAQ (abstract, [0178]-[0189], page 38). Embraced within said azobenzene pharmaceutical compositions includes pharmaceutical formulations including said compound in a sterile aqueous solution with a buffer or, alternatively as a lyophilized solid suitable for reconstitution ([0210]-[0212]).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to formulate the pharmaceutical composition comprising the art-recognized low aqueous solubility azobenzene compounds of Formula (I) formulated in an alkylated cyclodextrin a ratio of 1:10 as taught by Mourot, Van Gelder, Zhang and Bortolus wherein said composition is either as an aqueous composition comprising an osmolality of 250-350 mOsm, or alternatively as a solid suitable for reconstitution in view of Trauner.
MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, it was known in the prior art of Trauner to prepare pharmaceutical compositions comprising the azobenzene scaffolds of Formula (I) in a sterile aqueous solution and a buffer or, alternatively as a lyophilized solid suitable for reconstitution. Accordingly, said skilled artisan would have applied the pharmaceutical formulations of Trauner above to the composition comprising the art-recognized azobenzene compound comprising low aqueous solubility of Formula (I) formulated in an alkylated cyclodextrin of Mourot, Van Gelder, Zhang and Bortolus above, arriving at the claimed composition yielding no more than one would expect from such an arrangement.
It is noted that the combination of Mourot, Van Gelder, Zhang, Bortolus and Trauner does not specifically teach wherein the aqueous solution containing the compound of Formula (I) and the alkylated cyclodextrin comprises an osmolality of 250-350 mOsm. However, it is considered well within the capabilities of one of ordinary skill in the art to optimize the osmolality of the aqueous composition comprising the compound of Formula (I) and alkylated cyclodextrin to provide optimal solubility conditions for the compound with art-recognized poor aqueous solubility. The osmolality of the aqueous composition comprising the compound of Formula (I) and alkylated cyclodextrin is a result effective parameter that will affect the physical properties of the final composition and is clearly a results effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success in order to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed osmolality, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 9-10, 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 20-21 of copending Application No. 18647758 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 20-21 of copending Application 18647758 are directed to the use of a compound of Formula (I), specifically the compound of instant claim 10, in combination with a cyclodextrin for the treatment of a retinal disorder in a subject in need, wherein the ratio of Formula (I) to cyclodextrin is 1:1 to 20:1 . For double patenting of previously disclosed, but newly claimed utility, please see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010), See Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) and Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003). We held 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." Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86.
In Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n. 9; see U.S. Patent No. 5,563,165 ("′165 patent"), at col.1 ll.11-14, col.3 ll.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n. 9; see U.S. Patent No. 5,760,068 ("′068 patent") col.97 l.49-col.108 l.29. After rejecting the patentee's objection to our consideration of the specification of the earlier patent, we determined that the later patent "merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent." Pfizer, 518 F.3d at 1363. As such, we concluded that the asserted claims of the later patent were not "patentably distinct" from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.
Thus, the holding of Geneva and Pfizer, 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," extends to any and all such uses disclosed in the specification of the earlier patent. Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86.
Conclusion
In view of the rejections set forth above, no claim is allowed.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621