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 1-8, 10, 12, and 21 are pending. Claims 1-7 and 21 are rejected. Claims 8, 10, and 12 are withdrawn.
Priority
This is a 35 U.S.C. 371 National Stage Filing of International Application No.
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, which claims priority under 35 U.S.C. 119(a-d) to
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. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d).
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-7 and 21) in the reply filed on 1/21/2026 is acknowledged. The traversal is on the ground(s) that “novel processes for the preparation of opicapone and novel intermediates used therein”. This is not found persuasive because opicapone is a known compound and WO2019123066 teaches instant claim 1, step d process on the bottom of p. 3:
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(particularly the last two steps of the prior art shown supra), wherein P of Formula (VI) is methyl. Additionally, instant claim 1 is drawn to “one or more of the following steps” (see instant claims p. 3, line 3), wherein only one of the steps a through d is required.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8, 10 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 4 is objected to because of the following informalities:
Line 2 should read: “is carried out in the presence of a base which refers to an inorganic base”.
Line 9: insert an “an” before “organic base”.
Lines 12 and 13 refer to “tert.butoxide”. Because each claim should only have one period, Examiner recommends replacing with “tert-butoxide”.
Appropriate correction is required.
Claim 5 is objected to because of the following informalities:
On p. 5, line 2, “dimethylaminopropyl” has a space within the name;
On p. 5, line 2, Examiner recommends replacing “EDC.HCI” with “EDC·HCl”;
On p. 5, line 4, “Uranium” should be replaced with “uranium”.
Appropriate correction is required.
Claim 21 is objected to because of the following informalities:
Line 2 should read: “the presence of a base which refers to an inorganic base or an organic base; said inorganic base is selected from “alkali….”.
Line 9: insert an “an” before “organic base”.
Lines 12 and 13 refer to “tert.butoxide”. Because each claim should only have one period, Examiner recommends replacing with “tert-butoxide”.
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 1-7 and 21 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.
Regarding claim 1, p. 3, line 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner recommends replacing “such as” with “selected from the group consisting of”.
Regarding claim 1, p. 3, line 8, the phrase "and the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Examiner recommends eliminating this phrase.
Claims 2-7 and 21 are rejected from depending from an indefinite claim 1 and failing to remedy its deficiencies.
Regarding claim 4 (multiple locations), the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner recommends replacing “such as” with “selected from the group consisting of”.
Regarding claim 4 (multiple locations), the phrase "and the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Examiner recommends eliminating this phrase.
Regarding claim 5, p. 5, line 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner recommends replacing “such as” with “selected from the group consisting of”.
Regarding claim 5, beginning with “suitable Uranium reagent” and the remainder of the last three lines on p. 5, it is unclear as to what the role of such uranium reagent is. There is not a reference of such a reagent in the instant specification. Examiner recommends that the role of said uranium reagent be clarified, with full support from instant disclosure.
Regarding claim 6, line 3, the phrase "and the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Examiner recommends eliminating this phrase.
Claim 7 is rejected because it refers to “the process exemplified in the description” of the instant specification. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention. MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)”. In the instant case, “specific figure or table” may be interchangeable with a general “process exemplified in the description”. Additionally, it is unclear which process is specifically being referred to in the description. Examiner is utilizing the following paragraph from the middle of p. 8 of the instant specification in the interest of compact prosecution:
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.
Regarding claim 21 (multiple locations), the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner recommends replacing “such as” with “selected from the group consisting of”.
Regarding claim 21 (multiple locations), the phrase "and the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Examiner recommends eliminating this phrase.
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.
Claim(s) 1-7 and 21 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sathe et al. (WO2019123066).
Regarding instant claims 1-7 and 21, line 3 on p. 3 of claim 1 requires only “one or more of the following steps”. Examiner is focusing on the step d of claim 1, wherein all the other steps a through c are not required.
Sathe teaches instant claim 1, step d process on the bottom of p. 3:
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(particularly the last two steps of the prior art shown supra), wherein P of Formula (VI) is methyl. Additionally, on page 8, middle of page, of the instant specification, it is described that the conversion of the compound of formula (VI) to Opicapone can be done by “any other process known in the art” (see rejection of claim 7 under 112(b) supra). Claims 2-6 and 21 are not required limitations (because they are unrelated to the specifics of instant claim 1, part d) and are therefore rejected as being dependent from instant claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626