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
Claims 1-22 are currently pending in the instant application. Claims 1-10 and 13-16 are rejected and claims 11-12 and 17-22 are considered allowable in this Office Action.
I. Priority
The instant application is a 371 of PCT/US21/22187, filed on March 12, 2021.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 14, 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
III. Rejections
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.
Claims 1 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beckwith, et al. (WO 2018172997 (A1), abstract, Accession No. 2018:1796156). A recitation of the intended utility in the preamble does not impart patentability to a known composition. In re Spada, 911 F.2d 705, 15 U.S.P.Q.2d 1655 (Fed. Cir. 1990).
The instant invention claims
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The Beckwith, et al. reference teaches isoxazolecarboxamide compounds such as
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(See RN 2245258-45-9, page 10) wherein R1 is fluorophenyl; R2 is H; R3 is keto; R5 is H and R4 is –(CH2)5-OH. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
Claims 1 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tait, et al. (WO 2014210159 (A1), abstract, Accession No. 2014:2182008). A recitation of the intended utility in the preamble does not impart patentability to a known composition. In re Spada, 911 F.2d 705, 15 U.S.P.Q.2d 1655 (Fed. Cir. 1990).
The instant invention claims
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The Trait, et al. reference teaches isoxazolecarboxamide compounds such as
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(See RN 1643454-66-3, page 3) wherein R1 is phenyl; R2 is H; R3 is keto; R5 is H and R4 is –(CH2)5-OH. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
Claims 1 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dannhardt, et al. (European Journal of Medicinal Chemistry (abstract), 1995, 30(11), 839-50, Accession No. 1995:989621). A recitation of the intended utility in the preamble does not impart patentability to a known composition. In re Spada, 911 F.2d 705, 15 U.S.P.Q.2d 1655 (Fed. Cir. 1990).
The instant invention claims
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The Dannhardt, et al. reference teaches isoxazolecarboxamide compounds such as
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(See RN 60148-37-0, page 2) wherein R1 is methyl; R2 is H; R3 is H; R5 is methyl and R4 is methyl. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
Claims 1 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dannhardt, et al. (Archiv der Pharmazie (Weinheim, Germany) (abstract), 1995, 328(5), 437-43, Accession No. 1995:609514). A recitation of the intended utility in the preamble does not impart patentability to a known composition. In re Spada, 911 F.2d 705, 15 U.S.P.Q.2d 1655 (Fed. Cir. 1990).
The instant invention claims
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The Dannhardt, et al. reference teaches isoxazolecarboxamide compounds such as
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(See RN 1017-08-9, page 1) wherein R1 is phenyl; R2 is H; R3 is H; R5 is methyl and R4 is methyl. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
Claims 1 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem SID 381725922 (March 28, 2019). A recitation of the intended utility in the preamble does not impart patentability to a known composition. In re Spada, 911 F.2d 705, 15 U.S.P.Q.2d 1655 (Fed. Cir. 1990).
The instant invention claims
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The PubChem SID 381725922 reference teaches an isoxazole compound such as
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wherein R1 is methyl; R2 is H; R3 is H; R5 is hydrogen and R4 is methyl. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
35 USC § 103 - OBVIOUSNESS REJECTION
The following is a quotation of 35 U.S.C. § 103(a) that forms the basis for all
obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Tait, et al. (WO 2014210159 (A1), abstract, Accession No. 2014:2182008). A recitation of the intended utility in the preamble does not impart patentability to a known composition. In re Spada, 911 F.2d 705, 15 U.S.P.Q.2d 1655 (Fed. Cir. 1990).
. Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
Tait, et al. teaches isoxazolecarboxamides for modulating CFTR activity and a method of treating a condition associated with a dysfunction of proteostasis. The invention is represented by the general formula:
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The prior art also teaches specific compounds such as
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(See RN 1643454-66-3, page 3) wherein R1 is phenyl; R2 is H; R3 is keto; R5 is H and R4 is –(CH2)5-OH.
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Tait, et al. and the instant invention is that presence of two methyl groups on the alkyl chain in the instant compound
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vs. hydrogens substituted at the same position in the prior art’s compound
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.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
Compounds that differ only by the presence or absence of an extra methyl group
or two are homologues. Homologues are of such close structural similarity that
the disclosure of a compound renders prima facie obvious its homologue. As
was stated in In re Grose, 201 USPQ 57, 63, “The known structural relationship
between adjacent homologues, for example, supplies a chemical theory upon
which a prima facie case of obviousness of a compound may rest.” The
homologue is expected to be preparable by the same method and to have
generally the same properties. This expectation is then deemed the motivation
for preparing homologues. Of course, these presumptions are rebuttable by the
showing of unexpected effects, but initially, the homologues are obvious even in
the absence of a specific teaching to add or remove methyl groups. See In re
Wood, 199 USPQ 137; In re Hoke, 195 USPQ 148; In re Lohr, 137 USPQ 548;
In re Magerlein, 202 USPQ 473; In re Wiechert, 152 USPQ 247; Ex parte
Henkel, 130 USPQ 474; In re Jones, 74 USPQ 152, 154; In re Herr, 134 USPQ
176; Ex parte Dibella, 157 USPQ 59; In re Zickendraht, 138 USPQ 22; Ex
Parte Fischer, 96 USPQ 345; In re Fauque, 121 USPQ 425; In re Druey, 138
USPQ 39; In re Bowers and Orr, 149 USPQ 570; Redox Technologies Inc. v.
Pourreau, 73 USPQ2d 1435, 1451; In re Henze, 85 USPQ 261.
For example, it is obvious to prepare a dimethyl substituted alkyl group when the art teaches a hydrogen substituted alkyl group with a reasonable expectation of success. Specifically, a hydrogen and methyl are considered homologues and are obvious absent unexpected results. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to prepare homologs based on the teachings of the preferred embodiments in the prior art. For example, a skilled artisan would be motivated to add methyl groups to a known compound instead of hydrogens as seen in the prior art reference of Tait, et al. A strong prima facie obviousness has been established.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 2-5 and 13-16 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. Specifically, the term “comprises” found in phrase “compound further comprises” renders the products indefinite as the term “comprises” can be considered open-ended language when not clearly defined and therefore is including additional subject matter in the compounds of the formula I that is not described in the instant specification and is not particularly pointed out or distinctly claimed. A claim to a chemical compound cannot be open-ended, but must be claimed with precision. This rejection can be overcome by amending the phrase “compound further comprises” to read “compound is" in claims 2-5 and 13-16.
IV. Objections
Claims 2-5 and 13-16 are objected to because of the following informalities: not ending in a period. Each claim begins with a capital letter and ends with a period (MPEP 608.01 (m)). Appropriate correction is required.
V. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Joseph McKane can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626