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 of species in the reply filed on 07/02/2026 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)).
Examiner acknowledged clerical error in office action of 05/04/2026. Claims 16 is subjected to election of species requirement.
Applicant elected compliant species of compound of formula (I):
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Examiner did not find prior art for applicant elected species.
Therefore, Markush search was extended to the specie
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scorresponding to compound of formula I wherein R1 is oxo; one R2 is F and two R2 is H; X is a bond; and A is
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. The species read on claims 1-2, 7, 15, 19, 24, 27, 35-37 and 43.
Claims 16,20-23, 25-26 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/02/2026.
Claims 1-2, 6-7, 15, 19, 24, 27, 35-37 and 43 are examined in this office action.
Current Status of 18/435,117
This Office Action is in response to the amended claims of 06/14/2024.
Claims 1, 6-7, 20, 22-23, 25-26, and 35 are original; claims 2,15-16, 19, 21, 24, 27, 31, 36-37 and 43 are currently amended.
Claims 16,20-23, 25-26 and 31 are withdrawn.
Claims 1-2, 6-7, 15, 19, 24, 27, 35-37 and 43 are examined in this office action.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 06/14/2024, 07/18/2024, 07/14/2025, and 04/24/2026. 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 02/08/2023.
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.
Claim 35 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 35 directs to a table which is not present in the claim set. 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) (MPEP 2173.05). Therefore, this renders metes and bounds of the claim 35 undefine, hence renders claim 35 indefinite. As drafted, the Applicants could amend the Table within the Specification after allowance (prosecution formally ends) and still get a patent to an unexamined amendment. Therefore, reference to Tables 1-7 of claim 35 renders claim 35 indefinite.
Please copy the limitations from Tables 1-7 into claim 35 to render moot this rejection.
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 1-2,6-7, 15, 19, 24, 27 and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Michael (WO-2022221673-A1).
Michael et.al. discloses the species
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(racemic mixture) corresponding to compound of formula (I), formula (Ia) or formula (Ib), formula (IId), wherein R1 is oxo; one R2 is F and two R2 is H; X is a bond; and A is
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(paragraph [00269] anticipating claims 1-2, 6-7, 15, 19, 24, 27 and 35-36.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 6-7, 15, 19, 24, 27 and 35-36 is/are rejected under 35 U.S.C. 103 as being obvious over
Michael (WO-2022221673-A1).
In view of
MONKHOUSE et.al (Journal of pharmaceutical Science;Vol. 66, No. 1, January 1977)
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
Michael et.al teaches the species
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(racemic mixture) corresponding to compound of formula (I), formula (Ia) or formula (Ib), formula (IId), wherein R1 is oxo; one R2 is F and two R2 is H; X is a bond; and A is
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(paragraph [00269]).
MONKHOUSE et.al teaches the chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt form (page 1, first paragraph)
2. Ascertaining the differences between the prior art and the claims at issue.
Although Michael et.al. teaches the underlying compound of formula I, Michael et.al. does not teach a pharmaceutical composition or pharmaceutical acceptable salt or excipients with compound of formula I.
Although MONKHOUSE et.al teaches the chemical, biological, physical, and economic characteristics of medicinal agents can be manipulated and, hence, often optimized by conversion to a salt, MONKHOUSE et.al does not teach a pharmaceutical composition or pharmaceutical acceptable salt or excipients with compound of formula I.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing pharmaceutical composition.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to convert compound of formula(I), such as
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(Michael, paragraph [00269]), into salt (MONKHOUSE et.al, page 1, paragraph 1) because the combination of the compound
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with salts is expected to produce pharmaceutical composition or pharmaceutically acceptable salt and excipients for enhance chemical, biological, physical, and economic characteristics. Thus a person skilled in the art would be expected develop pharmaceutical composition or pharmaceutically acceptable salt and excipients of compound
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to enhance chemical, biological, physical, and economic characteristics thus teaching claims 1-2, 7, 15, 19, 24, 27 and 35-36.
Conclusion
Claims 1-2, 7, 15, 19, 24, 27 and 35-36 are rejected.
Claims 37 and 43 are objected to for depending on rejected claim 1.
Please note claims 37 and 43 may be rejected in future Final office action, upon Markush search extension.
Examiner found more structures corresponding to formula (I) of claims 1-2, 7, 15, 19, 24, 27 and 35-36, and can be rejected in future Final office action.
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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