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 .
Claims 1-18 and 22-30, submitted on 13 December 2023, represent all claims currently under consideration.
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 15 June 2021.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted 13 December 2023, is acknowledged and has been considered.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claim 3 is objected to because of the following informalities: There is a superfluous semicolon “;” after methyl. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: There is a superfluous semicolon “;” after Claim 1. 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.
Claims 10, 13-15, 24, and 26-27 are 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- namely, machine, manufacture, composition of matter, and process claims. The claims are directed towards the use of the compounds of the invention. As such, the claims are not directed to a process, machine, manufacture, or composition of matter (See MPEP § 2173.05(q)).
Claim Rejections - 35 USC § 112(b)
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.
Claim 1 is 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. Claim 1 is indefinite because there is no “or” or “and” prior to –(CH2)q in the Markush grouping for variable R5. Claims 3-5, 10-18, 22, 27 and 29 are rejected as depending on an indefinite claim without resolving the underlying issue of indefiniteness.
Claim 1 is 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. Claim 1 is indefinite because from the definition for when Y is
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, it is unclear which end of the molecule is attached to the amine and which end of the molecule binds to the methylene group as both are represented by the same symbol. Claims 3-5, 10-18, 22, 27 and 29 are rejected as depending on an indefinite claim without resolving the underlying issue of indefiniteness.
Claim 2 is 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. Claim 2 is indefinite because there is no “or” or “and” in the Markush group for variable R11 prior to CF3.
Claim 2 is 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. Claim 2 is indefinite because it is unclear what this structure represents
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as there are two fragments with a lone pair of electrons present.
Claim 8 is 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. Claim 8 uses the word “about” to define each peak in the XRPD pattern. However, “about” is not defined in the specification, causing it to be unclear what error can be associated with each peak. As this error is undefined, it is therefore, indefinite.
Claim 9 is 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. Claim 9 is indefinite because the claim contains the limitation “substantially in accordance with”. This is not defined within the specification, causing the metes and bounds of this claim to be undefined, and therefore, indefinite.
Claims 13, 26 and 27 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. The claims are indefinite due to the limitation “and/or prophylaxis”. It is unclear how a method can be used to both treat and prevent a condition at the same time, as a condition can not be prevented once it is occurring. The Examiner suggests amending to “or prophylaxis”.
Claims 10, 13-15, 24, and 26-27 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. The claims are indefinite due to the “use” limitations. The “use” limitations render the metes and bounds of the claims undefined (hence rendering the claims indefinite) since there are no active gerund (“-ing”) ending verbs actually setting out each step required in a method claim. There is confusion as to whether the claims are intended to be method claims, given that “use” claims are non-statutory in nature (See 35 U.S.C. § 101 rejection, above) (See MPEP § 2173.05(q)).
Allowable Subject Matter
Claims 6 and 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 1-5, 8, 9, 11, 12, 16-18, 22, 23, 25, and 28-30 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: There is no prior art which teaches or suggests the compounds claimed in the examined application (See STN Search, Search Notes). The closest prior art comes from Bueno-Calderon(WO 2010/081904; Publication Date: 22 July 2010). Bueno-Calderon discloses 4-pyridone derivatives and their processes of preparation, pharmaceutical formulations thereof, and their use in chemotherapy of certain parasitic infections such as malaria (Abstract). Representative compounds disclosed include Example 1
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(Page 72), Example 24
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(Page 81), Example 31
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(Page 85), and Example 64
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(Page 99). However, these compounds do not contain the fused tricyclic moiety which is central to the compounds of the examined application, with no teaching, suggestion, or motivation found to modify these compounds to incorporate this moiety. Cross (Journal of Medicinal Chemistry, 2014, 57, 8860-8879) discloses 6-chloro-7-methoxy-4(1H)-quinolones for treatment of malaria based around the structure
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(Tables 1-3, 6). However, these compounds do not contain a tricyclic fused moiety, and there is no teaching, suggestion or motivation from Cross to further modify these compounds to form a fused tricyclic system as found in the compounds of the examined application. Nilsen (Journal of Medicinal Chemistry, 2014, 57, 3818-3834) discloses the anti-malarial compound
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; however, these compounds lack the fused tricyclic central scaffold found in the compounds of the examined application.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 1-5, 8-18 and 22-30 are rejected.
Claims 6 and 7 are objected to as dependent upon a rejected claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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 Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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