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 .
DETAILED ACTION
Claims 1-3, 5, 8-11, 14, 17, 18, 22, 24, 32, 33, 37-39, 41, 42, 49-53 and 55-61 are pending in the instant application.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements filed on June 28, 2024 and
July 2, 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.
Claim Objections
Claims 9, 14, 17, 22, 24, 32, 33, 37, 39, 41 and 53 are objected to because of the following informalities:
in claim 9, “claim1” should be changed to “claim 1” (line 1 of the claim);
in claim 14, “claim1” should be changed to “claim 1” (line 1 of the claim);
in claim 17, “claim1” should be changed to “claim 1” (line 1 of the claim);
in claim 22, “claim1” should be changed to “claim 1” (line 1 of the claim);
in claim 24, “claim1” should be changed to “claim 1” (line 1 of the claim);
in claim 32, “claim1” should be changed to “claim 1” (line 1 of the claim);
in claim 33, “claim1” should be changed to “claim 1” (line 1 of the claim);
in claim 37, “claim1” should be changed to “claim 1” (line 1 of the claim);
in claim 39, “claim1” should be changed to “claim 1” (line 1 of the claim);
in claim 41, “claim1” should be changed to “claim 1” (line 1 of the claim); and
in claim 53, the period near the end of the claim should be moved outside of the table as was originally placed.
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 1-3, 5, 8-11, 14, 17, 18, 22, 24, 32, 33, 37-39, 42 and 55-61 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.
Claim 1 is confusing because there are only two chemically possible available carbons in which a R1 substituent can be attached on the 2-oxo-1,2-dihydropyrimidinyl ring in instant formula I,
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. However, variable m can represent a maximum of 3. Therefore, claim 1 is indefinite.
Claims dependent on claim 1 which do not resolve the problem stated above in claim 1 are also found indefinite.
Claim 39 lacks antecedent from claim 1 because claim 1 does not state that the R1 and R2 variables can represent oxo as found in claim 39. Therefore, claim 39 is indefinite.
Claim 42 is indefinite because the K variable has not been defined for formula IA-4, IA-5 or IA-6. Note that the K variable has been defined for formula IA-2 and a different definition of variable K has been defined for formula IA-3 in claim 42.
Claim 56 is confusing because of the phrase “comprising administering the compound of claim 1” but claim 56 fails to state to whom or to what is receiving the administering. Therefore, claim 56 is indefinite. This rejection can be overcome by adding the phrase “to a patient in need of such treatment” to claim 56 after the phrase “comprising administering the compound of claim 1” {see paragraph [00174] on page 45 of the instant specification for support}.
Claim 59 improperly depends from claim 1 and should be made an independent claim, which would include all of the variable definitions.
Claims 60 and 61 lack antecedent basis from claim 1 because there is no earlier recitation in claim 1 for compounds of formula E as found in claim 60 or the specie as claimed in claim 61. Therefore, claims 60 and 61 are indefinite. This rejection can be overcome by amending to claim 60 to be an independent claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 33, 39, 60 and 61 are rejected under
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 33 fails to further limit claim 1 because the definition of variable L in claim 33 is the same as recited in independent claim 1 (i.e., same scope).
Claim 39 fails to further limit claim 1 because claim 39 is broader in scope than claim 1. Claim 1 does not state that the R1 and R2 variables can represent oxo as found in claim 39.
Claims 60 and 61 each fail to further limit claim 1 because each of claims 60 and 61 is broader in scope than claim 1. Claim 1 does not claim compounds of formula E as found in claim 60 or the specie as claimed in claim 61.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
WO 2020/150372 A1 has been indicated as an X-reference on the International Search Report for PCT/US2022/082474. WO 2020/150372 A1 teaches compounds of formula I,
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on pages 2-3. The difference between the compounds taught in WO 2020/150372 A1 and the instant claimed compounds of formula I,
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, is that of the X1 and X2 containing aromatic ring moiety {i.e., phenyl or pyridyl – see paragraphs [0078]-[0082] on page 19 of the WO} in the compounds of formula I,
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, in WO 2020/150372 A1 versus the cyclohexyl or cyclohexenyl ring moiety in the compounds of instant formula I,
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. Therefore, the instant claimed invention is free of the prior art of record.
Allowable Subject Matter
Claims 41 and 49-52 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 41 and 53 are objected to for reasons stated above under “Claim Objections”.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
August 4, 2026
Book XXIX, page 123
Prosecution Insights