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 1-5 are pending in this application.
Applicant is advised that the following claim language changes would improve clarity:
Claim 1, line 10: R1[,] and R2 [is] are each independently selected from the group consisting of R4, R5, R6, and R7 ;
Claim 1, line 21: R3 is selected from the group consisting of R8,8 R9, R10, and R11.
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.
Claims 1-5 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.
(1) In claims 1 and 3, “carbonic anhydrase target” (emphasis added) is
ambiguous. Does it mean different carbonic anhydrase types, e.g., CA-I, CA-VI, CA-IX, CA-XV? Or does it mean a target of carbonic anhydrase? The meaning is not clear.
(2) In claim 1, the phrase “compound that irreversibly binds to a carbonic anhydrase target as part of a pharmaceutical formulation” (emphasis added) is confusing. If the phrase were shortened to “compound that irreversibly binds to a carbonic anhydrase target
For these reasons, the claims are deemed indefinite. Dependent claims are included because they do not cure the deficiencies of independent claim 1.
Claim interpretation in view of indefiniteness issues
For the purpose of applying prior art, “carbonic anhydrase target” is interpreted to include carbonic anhydrase types such as, for example, CA-I, CA-VI, CA-IX, CA-XV. For the purpose of applying prior art, “compound that irreversibly binds to a carbonic anhydrase target as part of a pharmaceutical formulation” (emphasis added) is interpreted to include compound that has such binding property.
35 USC 102/103
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 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.
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.
Claims 1 and 3-5 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Matulis et al. (US 2015/0266900; hereinafter, Matulis).
Matulis (US 2015/0266900) exemplifies the following compound designated as “compound 2e” as an inhibitor of carbonic anhydrase: 2-{[4-aminosulfonyl)-2,3,5,6-tetrafluorophenyl]sulfonyl}ethyl acetate. See Example 4, page 11; claims 6-7. Structure of this compound is provided by the Examiner here:
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Solvent was removed and this compound was purified by two times crystallization from water (paragraph 190). Matulis’s claims 8-11 are directed to a composition for use in control of conditions where inhibition of carbonic anhydrase is necessary, such as glaucoma, obesity.
Instant claim 1 recites the language, “composition comprising an effective amount of a fluorinated benzenesulfonamide compound that irreversibly binds to a carbonic anhydrase target as part of a pharmaceutical formulation …” Instant claim 3 recites the language, “compound forms a vinylsulfone group in the presence of a nucleophilic amino acid of the carbonic anhydrase target and wherein the vinylsulfone group covalently binds to the nucleophilic amino acid of the carbonic anhydrase target.”
These are descriptions of the compound’s function or property. Matulis exemplifies a composition of the same compound (shown above) by disclosing said compound purified in water (paragraph 190). Matulis further discloses a medicinal composition of his compounds (claims 8-11). Because the same exact compound is disclosed by Matulis as claimed in the instant application, the same function or property would necessarily be possessed by Matulis’s compound and composition.
In the alternative, it would have been obvious to obtain a composition or pharmaceutical composition of Matulis’s compound 2e because Matulis teaches inhibition of carbonic anhydrase and treatment of conditions such as glaucoma and obesity. Compounds of instant application claims 1 and 3-5 read on Matulis’s compound 2e, which is encompassed by Matulis’s claim 6 and specifically recited in Matulis’s claim 7. Because Matulis’s fluorinated benzenesulfonamide compound is the same as Applicant’s fluorinated benzenesulfonamide compound, it would necessarily have the same function or property of irreversible binding to a carbonic anhydrase target or forming a vinylsulfone group in the presence of a nucleophilic amino acid of the carbonic anhydrase target, wherein the vinylsulfone group covalently binds to the nucleophilic amino acid of the carbonic anhydrase target.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited reference.
35 USC 103
Claims 1 and 3-5 are under 35 U.S.C. 103 as being unpatentable over Matulis (US 2015/0266900).
Matulis (US 2015/0266900) exemplifies the following compound designated as “compound 2e” as an inhibitor of carbonic anhydrase: 2-{[4-aminosulfonyl)-2,3,5,6-tetrafluorophenyl]sulfonyl}ethyl acetate. See Example 4, page 11; claims 6-7. Structure of this compound is provided by the Examiner here:
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Solvent was removed and this compound was purified by two times crystallization from water (paragraph 190). Matulis’s claims 8-11 are directed to a composition for use in control of conditions where inhibition of carbonic anhydrase is necessary, such as glaucoma, obesity. Additionally, Matulis disclosed a genus of compounds wherein the acetate moiety can increase in chain length to propionate when n = 4, A is SO2R1, R1 is R5, R5 is CH2CH2 substituted by R8, R8 is R12, and R12 is methyl or ethyl. See Matulis’s claim 1. When R12 is ethyl, the resultant compound can be a variation of Matulis’s compound 2e, which is the first compound listed in Applicant’s claim 2, “2-((2,3,5,6-tetrafluoro-4-sulfamoylphenyl)sulfonyl)ethyl propionate.”
Instant claim 1 recites the language, “composition comprising an effective amount of a fluorinated benzenesulfonamide compound that irreversibly binds to a carbonic anhydrase target as part of a pharmaceutical formulation …” Instant claim 3 recites the language, “compound forms a vinylsulfone group in the presence of a nucleophilic amino acid of the carbonic anhydrase target and wherein the vinylsulfone group covalently binds to the nucleophilic amino acid of the carbonic anhydrase target.”
These are descriptions of the compound’s function or property. Matulis exemplifies a composition of the same compound (shown above) by disclosing said compound purified in water (paragraph 190). Matulis further discloses a medicinal composition of his compounds (claims 8-11). Because the same exact compound is disclosed by Matulis as claimed in the instant application, the same function or property would necessarily be possessed by Matulis’s compound and composition.
It would have been obvious to obtain a composition or pharmaceutical composition of Matulis’s compound 2e or its propionate variation (as discussed above) because Matulis teaches inhibition of carbonic anhydrase and treatment of conditions such as glaucoma and obesity. Compounds of instant application claims 1-5 read on Matulis’s compound 2e and its propionate variation, which is encompassed by Matulis’s claim 6 and specifically recited in Matulis’s claim 7. Because Matulis’s fluorinated benzenesulfonamide compound is the same as Applicant’s fluorinated benzenesulfonamide compound, it would necessarily have the same function or property of irreversible binding to a carbonic anhydrase target or forming a vinylsulfone group in the presence of a nucleophilic amino acid of the carbonic anhydrase target, wherein the vinylsulfone group covalently binds to the nucleophilic amino acid of the carbonic anhydrase target.
In this regard, it is well established that “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Baxter Travenol Labs, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991). In Baxter, the court held that even when the prior art did not expressly disclose hemolysis-suppression feature or property of a blood bag plasticizer, such unrecognized feature or property is insufficient for rebutting a prima facie case of obviousness over a prior art blood bag that utilized the same plasticizer. Id. Here, the facts are nearly identical in that ......
See also Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Int. 1985) (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious”).
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited reference.
For these reasons, all claims are rejected at this time. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to JOHN PAK whose telephone number is (571)272-0620. The Examiner can normally be reached on Monday to Friday from 8:30 AM to 5 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's SPE, Fereydoun Sajjadi, can be reached on (571)272-3311. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/JOHN PAK/Primary Examiner, Art Unit 1699