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, 5-7, and 9-20 are pending in the instant application.
Election/Restrictions
Applicant’s election with traverse of Group I,
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and the species of Compound 39, disclosed on page 17 of the instant specification and claimed in instant claim 13 (reproduced below),
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in the reply filed on December 1, 2025 is acknowledged.
The traversal is on the ground(s) that the Restriction Requirement is improper because a national stage application containing claims to different categories of invention will be considered to have unity of invention. Applicant also argues that the international application from which this application was filed was recognized as complying with the PCT unity of invention requirements. Applicant further argues that the current presented claims require the technical feature of a tricyclic heterocyclic ring which includes at least 2 nitrogens. Additionally, Applicant requests rejoinder of the method claims.
All of Applicant’s arguments have been considered but have not been found persuasive. Applicant argues that claims to different categories of invention will be considered to have unity of invention.
In response, unity of invention was determined to be lacking because the technical feature of a nitrogen containing tricyclic ring does not make a contribution over the prior art. Therefore, the Restriction is deemed proper.
Applicant argues that the international application from which this application was filed was recognized as complying with the PCT unity of invention requirements.
In response, the Examiner in the National phase of a 371 application is not bound by any unity of invention determination that occurred during the International phase. Likewise, even where unity of invention was not found to be lacking during the International phase, the Examiner may nevertheless require restriction for the first time in the National phase. Therefore, Applicant’s argument is not found persuasive.
Applicant argues that the claims have been amended and that the compound of Chemical Abstracts Registry Number 2343952-36-1, which was cited in the Restriction on pages 8-9, does not fall within formula (I) of currently amended claim 1.
In response, it is agreed that the compound of Chemical Abstracts Registry Number 2343952-36-1 is not embraced by currently amended claim 1. However, the technical feature of a nitrogen containing tricyclic ring in the currently amended claims does not make a contribution over the prior art. See below prior art rejections. Therefore, Applicant’s argument is not persuasive.
Applicant has requested rejoinder of the non-elected invention of Group II, which is directed to a method of use.
In response, in accordance with MPEP §1893.03(d) and §821.04 and In re Ochiai, 71 F.3d 1565, 37 USPQ 1127 (Fed. Cir. 1995), rejoinder of product claims with process claims commensurate in scope with the allowed product claims will occur following a finding that the product claims are allowable. Until, such time, a restriction between product claims and process claims is deemed proper. Additionally, in order to retain the right to rejoinder in accordance with the above policy, Applicant is advised that the process claims should be amended during prosecution to maintain either dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder.
The requirement is still deemed proper and is therefore made FINAL.
The product claims of elected Group I have been searched and examined in their entirety.
Claims 15 and 17-19 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. Applicant timely traversed the restriction (election) requirement in the reply filed on December 1, 2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements filed on June 29, 2023,
January 21, 2025, May 28, 2025 and November 7, 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 1 and 6 are objected to because of the following informalities:
in claim 1, an “and” should be added before the definition of variable Rb since variable Rb is the last variable being defined in the claim (3rd line from the end of the claim); and
in claim 6, an “and” should be added after “S,” in the phrase “N, O, S, S(O)2” for proper Markush language format (line 5 of the claim).
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.
Claim 20 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 20 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 that ring A can represent a pyrrole ring when X1 and X2 both are CH as found in claim 20 (line 4 of the claim). Therefore, claim 20 is indefinite.
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.
Claim 20 is 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 20 fails to further limit claim 1 because claim 20 is broader in scope than claim 1 because of the pyrrole ring,
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, under the definition of ring A in claim 20 (line 4 of the claim). In claim 1, when X1 and X2 both are CH, ring A does not represent a pyrrole ring.
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.
Claim Rejections - 35 USC § 103
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 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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 5-7, 10, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al. {Organic Letters, Vol. 20, No. 22, November 2018, pages 7216-7219}, taken alone, and in combination with the compound of Chemical Abstracts Registry Number 2248030-54-6 {indexed in the Registry file on STN CAS ONLINE November 13, 2018}.
Determination of the scope and content of the prior art (MPEP §2141.01)
Applicant claims compounds of formula (I),
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wherein
L can represent a chemical bond or oxygen;
R1 can represent halogen or C1-C10 alkyl;
X1 can represent N;
X2 represents CH;
ring A can represent a 6-membered heteroaryl
(i.e., pyridyl) substituted with R2;
R2 can represent C1-C10 alkyl;
X can represent C;
Y can represent C; and
ring Q can represent a 10-membered heteroaryl
(i.e., quinolyl).
Honeycutt et al. teach heterocycle containing phenanthridinones that are structurally similar to the instant claimed compounds. See Compound 3y in Scheme 4 on page 7218 (reproduced in-part below),
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Ascertainment of the difference between the prior art and the claimed invention (MPEP §2141.02)
The difference between Compound 3y in Honeycutt et al. and the compounds instantly claimed is the absence of a lower alkyl group (i.e., a methyl group) attached to the 8-position in Compound 3y of Honeycutt et al. (i.e., the instant -L-R1 moiety in formula (I) where L is a chemical bond and R1 is C1 alkyl). Compound 3y in Honeycutt et al. is considered a homolog of the instant claimed compounds of formula (I)
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when L = a chemical bond; R1 = C1 alkyl; X1 = N; X2 = CH;
ring A = a 6-membered heteroaryl (i.e., pyridyl) substituted with R2; R2 = C1 alkyl; X = C; Y = C; and ring Q = a 10-membered heteroaryl (i.e., quinolinyl).
Finding of prima facie obviousness--rational and motivation
(MPEP §2142-2143)
It is well established that the substitution of a lower alkyl for a hydrogen atom on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 53 U.S.P.Q. 40 (C.C.P.A. 1942), In re Druey, 138 USPQ 39 (C.C.P.A. 1963), In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., an antiviral or anticancer therapeutics). Also see MPEP §2144.09(II).
Further, Honeycutt et al. teach other heterocycle containing phenanthridinones in which one of the nitrogen containing rings in the tricyclic ring system is substituted with a methyl, a methoxy, a fluoro atom and a chloro atom. See the definitions of the
R variable in Compounds 3b-3e in Scheme 2 on page 7217 of Honeycutt et al. (reproduced in-part),
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and the definition of the instant -L-R1 moiety in formula (I). Therefore, one skilled in the art would be motivated to modify Compound 3y in Honeycutt et al.,
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by preparing homologs thereof (i.e., a lower alkyl) or substituting the nitrogen ring identified above with substituents such as methoxy, a fluoro or a chloro because such substitutions are suggested by Honeycutt et al. on his heterocycle containing phenanthridinones.
Additionally, the Registry record for the compound of Chemical Abstracts Registry Number 2248030-54-6,
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(which corresponds to Compound 3y in Honeycutt et al.), discloses the predicted solubility of this compound in water. Water is a well-known pharmaceutically acceptable excipient. See pages 766-770 in Rowe, Raymond C, Paul J. Sheskey, and Marian E Quinn. Handbook of Pharmaceutical Excipients. London: Pharmaceutical Press, 6th Edition, 2009. The instant claimed invention would have been suggested to one of ordinary skill in the pharmaceutical arts and therefore, the instant claimed invention would have been obvious to one of ordinary skill in the pharmaceutical art.
Claims 1-3, 5-7, 9-12, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. {EP 459,505 A1}.
Determination of the scope and content of the prior art (MPEP §2141.01)
Applicant claims compounds of formula (I),
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wherein
L can represent a chemical bond;
R1 can represent C1-C10 alkyl;
X1 can represent N;
X2 represents CH;
ring A can represent a 5-membered heteroaryl
(i.e., imidazolyl) optionally substituted with R2;
R2 can represent C1-C10 alkyl, etc.;
X can represent C;
Y can represent C;
ring Q can represent a C6–C10 aryl (i.e., phenyl or
naphthyl) optionally substituted with R3; and
R3 can represent halogen, C1-C10 alkyl, and C1-C10 alkoxy.
Suzuki et al. (page 3) teach compounds of formula (I),
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wherein
R1 can represent an aryl (such as phenyl or
naphthyl), substituted or unsubstituted;
X-Y-Z represents
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or
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;
R2 can represent hydrogen, lower alkyl, etc.; and
R3 can represent hydrogen or lower alkyl.
The compounds of Suzuki et al. are structurally similar to the instant claimed compounds. See Compounds 2, 5, 6, 3, 8, 22, 25, 26, etc. in the tables on pages 10-15 in Suzuki et al.,
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Suzuki et al. teach pharmaceutical compositions comprising his compounds together with pharmaceutically acceptable carriers such as water (page 26, lines 24-48).
Ascertainment of the difference between the prior art and the claimed invention (MPEP §2141.02)
The difference between the compounds of Suzuki et al. and the instant claimed compounds is the absence of a lower alkyl group (i.e., a methyl group) attached to the 7-position of the 3,5-dihydro-5-phenyl-4H-imidazo[4,5-c][1,8]naphthyridin-4-one ring in the compounds of formula (I),
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, in Suzuki et al. (i.e., the instant -L-R1 moiety in formula (I) where L is a chemical bond and R1 is C1-C10 alkyl). The compounds in Suzuki et al. are considered homologs of the instant claimed compounds of formula (I),
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when L = a chemical bond; R1 = C1-C10 alkyl; X1 = N;
X2 = CH; ring A = a 5-membered heteroaryl (i.e., imidazolyl) optionally substituted with R2; R2 = C1 alkyl; X = C; Y = C; ring Q = aryl (i.e., phenyl or naphthyl) optionally substituted with R3; and R3 = halogen, C1-C10 alkyl and C1-C10 alkoxy.
Finding of prima facie obviousness--rational and motivation
(MPEP §2142-2143)
It is well established that the substitution of a lower alkyl for a hydrogen atom on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 53 U.S.P.Q. 40 (C.C.P.A. 1942), In re Druey, 138 USPQ 39 (C.C.P.A. 1963), In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., anti-inflammatory activity or anti-allergic activity). See also
MPEP §2144.09(II). The instant claimed invention would have been suggested to one of ordinary skill in the pharmaceutical arts and therefore, the instant claimed invention would have been obvious to one of ordinary skill in the pharmaceutical art.
Allowable Subject Matter
The elected species of Compound 39 is free of the prior art of record.
Claims 13 and 16 are allowed over the prior art of record.
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
February 3, 2026
Book XXVIII, page 285