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 .
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.
Election/Restrictions
Applicant’s election in the reply filed on 10/28/2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant elected a compliant species of compound of formula (I):
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Examiner did not find prior art for applicant’s elected species.
Therefore, the Examiner extended the Markush search to the full scope of genus formula I of instant claim 1, but did not find any prior art on compounds of the illustrated genus formula I.
The Examiner extended the Markush search to
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, wherein X is CR3; R3 is F(halogen); R5 is H; R1 is -CH3; R2 is -Cl; R4 is H; and W is H, which Examiner interprets as a prodrug or metabolite of genus formula I of instant claim 1, which retrieved prior art.
Therefore, per Markush search practice, the Markush search will not be extended unnecessarily to additional species of prodrugs or metabolites of genus formula I of instant claim 1 in this Office Action.
Claims 1-14 reads on the Markush search extension.
Current Status of 18/252,313
This Office Action is in response to the amended claims of 10/28/2025.
Claims 1-3 and 7 currently amended; claims 4-6 and 8-14 were previously presented.
Claims 1-14 are examined in this office action.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 05/10/2023 and 08/12/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 11/09/2021 based on PCT/CN2021/129655.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 1 is objected to because on underline section in claim 1 shown below
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Applicant is advised to change the underlined section from “R2 is selected from hydrogen, halogen, cyano, and” to -- R2 is selected from hydrogen, halogen and cyano, --.
Appropriate correction is required.
Claim 4 is objected because X cannot be C and N at the same time. Applicant is advised to add -- when-- before the circled Xs in claim 4 as shown below.
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Applicant is also advised to add -- or-- between the above paragraphs.
Appropriate correction is required.
Claim 5 is objected because X cannot be C and N at the same time. Applicant is advised to add “when” before the circled Xs in claim 5 as shown below
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Applicant is also advised to add -- or-- between the above paragraphs.
Appropriate correction is required.
Claim 6 is objected because X cannot be C and N at the same time. Applicant is advised to add “when” before the circled Xs in claim 6 as shown below
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Applicant is also advised to add -- or-- between the above paragraphs.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 11 is constructed in “use” form and does not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. 101 (process, machine, manufacture, or composition of matter) (see MPEP 2173.05(q)). “Use” is not one of the 4 statutory categories of inventions.
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 11 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.
Claims 11, drawn to “Use of”, is properly interpreted as a “use” claim. As such, the metes and bounds of claims 11 is undefined (hence rendering claim 11 indefinite) since claim 11 attempts to claim a process without setting forth any active steps involved in the process. As such, the artisan has no idea what active steps (active verbs) are needed to conduct the “use” claim. Use claims are indefinite because they merely recite a use without any active, positive steps delimiting how the use is actually practiced. See MPEP 2173.05(q).
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.
Claim(s) 1-6, 8-9 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feldman et.al. (WO 00/69836).
Claims 1-6 are drawn to compound of formula (I). Feldman et.al disclose the compound
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(page 67), examiner is interpreting this as metabolites or prodrug of compound of formula (I) of instant claim 1 and pharmaceutical acceptable salts, thus anticipating claims 1-6. Claim 8 is drawn to pharmaceutical composition drawn to salts of metabolites or prodrug of compound of formula I where the effective amount is 10mg-3000mg, Feldman discloses administering 10mg-100mg of (page 75, line 7-27) metabolites or prodrug, thus anticipating claim 8. Claims 9 and 14 is drawn to salts of compound of formula I and its metabolites or prodrug, Feldman discloses pharmaceutical salt to including salts formed by following acids (hydrochloric, hydrobromic, sulfuric, nitric, phosphoric, salicylic, p-toluenesulfonic, tartaric, citric, methanesulfonic, maleic, formic, malonic, succinic, isethionic, lactobionic, naphtalene-2-sulfonic, sulfamic, ethanesulfonic and benzenesulfonic(page 68-67), thus anticipating claims 9 and 14. Claim 11 is drawn to compound of formula I and its metabolites or prodrug for manufacturing a medicament for sedation and anesthesia, Feldman et.al discloses compound
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used for sedation and anesthesia (abstract), thus anticipating claim 11. Claims 12-13 are drawn to method of sedation or anesthesia comprising of intravenous administration of metabolites or prodrug of compound of formula (I), Feldman et.al disclose intravenous administration of metabolites or prodrug of compound of formula (I) (page 75, line 7-27) thus anticipating claims 12-13.
Conclusion
Claims 1-6, 8-9 and 11-14 are rejected.
Claims 7 and 10 are objected to for depending on rejected claim 1.
Applicants are encouraged to strikes metabolite and prodrug from the claims to overcome 102 rejections and expedite allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571)272-913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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