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 .
Priority
The instant application is a continuation of international application PCT/US2022/046421, filed October 12, 2022, which claims the benefit of an effective US filing date under 35 USC 119(e) from US Provisional Applications 63/255,244, filed October 13, 2021.
Information Disclosure Statement
The information disclosure statement dated April 12, 2024 was in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS document was considered and a signed copy of the 1449 form is attached.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I (claims 1-11), in the reply filed June 16, 2026 is acknowledged. Further, Applicant’s election without traverse of the compound
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in the same reply is also acknowledged. Claims 1-4, 6 and 9-11 within the elected group read on the elected species.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the Examiner searched the claimed invention based on the elected species above, wherein: no prior art was discovered over the elected species. Accordingly, the scope of search and consideration has been expanded further to include the compound recited in the prior art rejections herein.
Status of Claims
Currently, claims 1-15 are pending in the instant application. Claims 5, 7-8 and 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species. Claims 1-4, 6 and 10-11 read on an elected invention and species and are therefore under consideration in the instant application to the extent that they read on the elected embodiment and extended scope described above.
Claim Objections
Claim 9 is objected to for containing typographical errors. The formatting of the table is skewed at the bottom of page numbered 14, such that the last depicted compound has part of its structure contained within the column for the chemical name. Further, the claim lacks a period at the end. Appropriate correction is required.
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.
Claims 2 and 6 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 pre-AIA the applicant regards as the invention.
The claims recite the limitation that R1 (a monovalent position) can be OCF2 (a divalent substituent. Therefore, it is unclear what is intended to be encompassed by this formula as the definition provided would leave an unfilled valence position on the carbon atom. Appropriate correction and clarification 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.
Claims 1-4, 6 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al.
Lee et al. teaches at least the compound UC2389 (see Supplemental Data, p. 21). The prior art compound has the structure
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, which reads on Formula I where R1 is CF3; R0 is B; Z is NH; t is 0; s and u are each 1; each of R4, R4’, R5, R5’, R6, R6’, R10, R10’ and R11 are H; and R3 is C(O)-alkyl. Since the prior art teaches all required features of the instant claims, the claims are anticipated.
Claims 1-4, 6 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9,850,207 (“the ‘207 patent”).
The ‘207 patent teaches methods of administering the compound
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(see claim 1). The reference also teaches the compound
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and many others which anticipate the instantly claimed formula (see FIG 1-16). The anticipatory compound reads on Formula I where R1 is CF3; R0 is B; Z is NH; t is 0; s and u are each 1; each of R4, R4’, R5, R5’, R6, R6’, R10, R10’ and R11 are H; and R3 is C(O)-alkyl. Further it is noted that data is provided for the anticipatory compounds having IC50 values in units of molarity, an indication that compositions anticipating those of the instant claims were necessarily prepared. Since the prior art teaches all required features of the instant claims, the claims are anticipated.
Claims 1-4, 6 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9,034,903 (“the ‘903 patent”).
The ‘903 patent teaches soluble epoxide hydrolase inhibitors such as
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(Example 3) and
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(Example 5), as well as many others which anticipate the instantly claimed formula (see FIG 2A-2B). The anticipatory compound reads on Formula I where R1 is CF3 or OCF3; R0 is B; Z is NH; t is 0; s and u are each 1; each of R4, R4’, R5, R5’, R6, R6’, R10, R10’ and R11 are H; and R3 is C(O)-alkyl or C(O)-O-alkyl. Further it is noted that data is provided for the anticipatory compounds having IC50 values in units of molarity, an indication that compositions anticipating those of the instant claims were necessarily prepared. Since the prior art teaches all required features of the instant claims, the claims are anticipated.
Claims 1-4, 6 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 10,377,744 (“the ‘744 patent”).
The ‘744 patent teaches soluble epoxide hydrolase inhibitors such as ((S)-1-(3-fluoro-4-(trifluoromethoxy)phenyl)-3-(1-(2-methylbutanoyl)piperidin-4-yl)urea (Compound 26) and
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.as well as many others which anticipate the instantly claimed formula (see Table 1). The anticipatory compound reads on Formula I where R1 is CF3 or OCF3; q is 0, or q is 1 where R2 is F; R0 is B; Z is NH; t is 0; s and u are each 1; each of R4, R4’, R5, R5’, R6, R6’, R10, R10’ and R11 are H; and R3 is C(O)-alkyl or C(O)-O-alkyl. Further it is noted that data is provided for the anticipatory compounds having IC50 values in units of molarity, an indication that compositions anticipating those of the instant claims were necessarily prepared. Since the prior art teaches all required features of the instant claims, the claims are anticipated.
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.
Claims 1-4, 6 and 10-11, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of US Patent 9,850,207.
Although the claims at issue are not identical, they are not patentably distinct from each other because, the claims of the conflicting patent are drawn to methods of administering the compound
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. Accordingly, since the patented claims recite the use of an anticipatory compound, a double patenting rejection is appropriate.
Claims 1-4, 6 and 10-11, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US Patent 9,034,903.
Although the claims at issue are not identical, they are not patentably distinct from each other because, the claims of the conflicting patent are drawn to compounds selected from 1-(1-(2-methylbutyryl)piperidin-4-yl)-3-(4-(trifluoromethoxy)phenyl)urea, (S)-1-(1-(2-methylbutanoyl)piperidin-4-yl)-3-(4-(trifluoromethyl)phenyl)urea, 1-(1-isobutyrylpiperidin-4-yl)-3-(4-(trifluoromethoxy)phenyl)urea, 1-(1-(2-ethylbutanoyl)piperidin-4-yl)-3-(4-(trifluoromethoxy)phenyl)urea, 1-(1-(2-ethylbutanoyl)piperidin-4-yl)-3-(4-(trifluoromethyl)phenyl)urea, (S)-1-(1-(2-methylbutanoyl)piperidin-4-yl)-3-(4-(trifluoromethyl)phenyl)urea, 1-cyclohexyl-3-(1-(2-methylbutanoyl)piperidin-4-yl)urea, 1-cycloheptyl-3-(1-(2-methylbutanoyl)piperidin-4-yl)urea, 1-(4-isopropylphenyl)-3-(1-(2-methyl butanoyl)piperidin-4-yl)urea, 1-(3,5-di-trifluoromethylphenyl)-3-(1-(2-methylbutanoyl)piperidin-4-yl)urea, 1-(4-tert-butylphenyl)-3-(1-(2-methyl butanoyl)piperidin-4-yl)urea, 1-(4-ethylcyclohexyl)-3-(1-isobutyrylpiperidin-4-yl)urea. Most of the recited compounds anticipate instant formula I. Further, pharmaceutical compositions are taught in conflicting claim 7. Accordingly, since the patented claims recite anticipatory compounds, a double patenting rejection is appropriate.
Claims 1-4, 6 and 10-11, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of US Patent 10,377,744.
Although the claims at issue are not identical, they are not patentably distinct from each other because, the claims of the conflicting patent are drawn to the compound (S)-1-(3-fluoro-4-(trifluoromethoxy)phenyl)-3-(1-(2-methylbutanoyl)piperidin-4-yl)urea (Compound 26) and
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. Accordingly, since the patented claims recite anticipatory compounds, a double patenting rejection is appropriate.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 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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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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