DETAILED ACTION
All rejections and objections not mentioned below have been withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/12/2026 has been entered.
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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
A date of was used for priority.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/24/2022, 10/31/2025 and 04/13/2026 are being considered by the examiner.
Claim Objections
Claims 4 is objected to because of the following informalities: poor compound image resolution. Appropriate correction is required.
Claims 1-3 and 6 is objected to because of the following informalities: the typo “hydroxyl up” instead of “hydroxyl group” and the lack of a space between “andR5”. Appropriate correction is required.
Claims objected to because of the following informalities: period after sulfonamide group instead of a comma. Appropriate correction is required.
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 and 6 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 use of the word “comprises” in claim 1 causes the scope of claims 1 -3 and 6 to be indefinite. It is unclear if the groups that contain the comprise language are limited to the listed substituents or can also contain other unlisted groups in addition. Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit." … (emphasis added). "Given the breadth of variation among the specified alternatives and the use of the open-ended word ’comprising’ to define the scope of the list, we affirm the Board's conclusion that the pending claims recite improper Markush language and are indefinite under § 112(b) ."). If a claim is intended to encompass combinations or mixtures of the alternatives set forth in the Markush grouping, the claim may include qualifying language preceding the recited alternatives (such as "at least one member" selected from the group), or within the list of alternatives (such as "or mixtures thereof"). Id. at 1281. See also MPEP § 2111.03. MPEP 2173.05(h).
The scope of claims 2 and 3 are also indefinite because it is unclear if R4 is also required to be substituted in some cases as it is required in claim 1 from which it depends. For example claim 3 list unsubstituted benzene as the R4 group but claim 1 requires a substituent and claim 2 does not mention a requirement for substituting some of the R4 groups.
Claim 3 is also indefinite because the R4 groups listed in claim 3 are not substituent groups but full molecules so it is unclear if the claim covers the substituent group or are suggesting these groups to bond by non-covalent means. For example benzene and hexane both have all their hydrogens and have no location for bonding covalently. For the purposes of examination the groups were interpreted as their substituent counter parts such as phenyl and hexyl groups. These are two examples but the rest of the R4 groups in claim 3 have the same issue.
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 2-3 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. For example claim 3 list unsubstituted benzene as the R4 group but claim 1 requires a substituent and claim 2 does not mention a requirement for substituting some of the R4 groups. Thus claims 2-3 broaden the scope of claim 1 from which they depend because the R4 groups allow for a broader range of groups than claim 1. 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 § 102
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.
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) 2, 3, is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Philip (Philip et al., US 2014/0072826 A1, 2014).
The reference Philip teaches the following compound (page 20):
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Wherein, Y1=R1=R2=Y2=R3=H, R4=C6 aryl. This anticipates claim 2 unsubstituted aryl group and claim 3 unsubstituted benzene.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a) as being clearly anticipated by STN (STN, CAS Registry Number 102025-92-3, Entered STN: May 10th, 1986).
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The reference STN teaches the following compound, which is the same compound of compound No. 144, (Compound No. 144: 4-benzyl-6,7-dimethoxyphthalazin-1(2H)-one).
This anticipates claim 5.
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.
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.
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.
Claim(s) 1-3 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jackson (Jackson et al., US 6635642 B1, 2003-10-21).
The reference Jackson teaches the following compound (column 45), wherein Y1=Y2=H, R1=R2=H, R3=H, R4=C6 aryl substituted with a nitro group, and C6 heterocyclic group.
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This anticipates claim 1-3.
The reference Jackson teaches "Pharmaceutically acceptable salt", "hydrate", "ester" or "solvate" refers to a salt, hydrate, ester, or solvate of the inventive compounds which possesses the desired pharmacological activity and which is neither biologically nor otherwise undesirable. Organic acids can be used to produce salts, hydrates, esters, or solvates such as acetate, adipate, alginate, aspartate, benzoate, benzenesulfonate, p-toluenesulfonate, bisulfate, sulfamate, sulfate, naphthylate, butyrate, citrate, camphorate, camphorsulfonate, cyclopentane-propionate, digluconate, dodecylsulfate, ethanesulfonate, fumarate, glucoheptanoate, glycerophosphate, hemisulfate heptanoate, hexanoate, 2-hydroxyethanesulfonate, lactate, maleate, methanesulfonate, 2-naphthalenesulfonate, nicotinate, oxalate, tosylate and undecanoate. Inorganic acids can be used to produce salts, hydrates, esters, or solvates such as hydrochloride, hydrobromide, hydroiodide, and thiocyanate” (columns 9 and 10).
This anticipates claim 6.
It is believed that Jackson anticipates the claim 6 with regards to the inorganic acids can be used to produce salts, however, for the sake of completeness of prosecution, purely arguendo and with regards to this particular ground of rejection only, it will be presumed that the prior art differs from the instant claims insofar as Jackson does not explicitly teach that the compound of the instant invention is a specific salt however, the reference does teach the use of the reference compounds to produce salts of the given specific examples and thus would be obvious if not anticipated. One would be motivated to do so to produce non-toxic pharmaceutically acceptable salts and one would have a reasonable expectation of success because the reference suggest producing the salts of the compounds by using the inorganic or organic acids.
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 (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.
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.
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over MARTIN (MARTIN et al., WO0236576A1, 2002-05-10) in view of Barillari (Barillari et al., Classical Bioisosteres, Bioisosteres in Medicinal Chemistry, First Edition. Edited by Nathan Brown, 2012).
The reference MARTIN teaches the following generic synthesis (page 40) and the following compound 697 Figure 9 (page 96), wherein Y1=Y2=H, R1=R2 =H,R4=
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:
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The reference MARTIN teaches “Further aspects of the invention provide for the use of compounds as defined in the first aspect of the invention in the preparation of a medicament for the treatment of: vascular disease; septic shock; ischaemic injury; neurotoxicity; haemorraghic shock; viral infection; or diseases ameliorated by the inhibition of the activity ofPARP”(page 6).
This helps to teach claim 4.
The reference MARTIN does not teach the correct R4 group
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, and instead has a methyl instead of a NH2 group.
The reference Barillari teaches “The discovery and development of a candidate for clinical evaluation is a long process that involves small modifications to a lead compound to improve some of its properties, such as pharmacological activity, selectivity, and pharmacokinetics. This is often achieved by the medicinal chemists by replacing a functional group with groups sharing similar physical or chemical properties and maintaining similar activity, which are defined as bioisosteres”(page 15) and the bioisosteres shown below.
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This helps to teach claim 4.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified MARTIN with Barillari because MARTIN suggests compounds to treat diseases including compound 697 and Barillari teaches that it is common practice for drug candidates (such as compound 697) to have small modifications made to them to improve some of its properties, such as pharmacological activity, selectivity, and pharmacokinetics. This is often achieved by the medicinal chemists by replacing a functional group with groups sharing similar physical or chemical properties and maintaining similar activity, which are defined as bioisosteres and that the change from CH3 to NH2 is one such bioisostere modification. One would have a reasonable expectation of success because CH3 and NH2 are bioisosteres. One would be motivated to do so to potentially improve some of its properties, such as pharmacological activity, selectivity, and pharmacokinetics for improved treatment of the mentioned diseases.
Response to Arguments
Applicant's arguments filed 03/12/2026 have been fully considered but they are not persuasive.
Applicants argument against the 102 rejection of claim 2 is unpersuasive because claim 2 does not mention a requirement for substituting some of the R4 groups including C6 aryl.
Applicants argument against the reference Jackson is moot as a new compound from Jackson has been highlighted due to the claims having been amended.
Applicant’s arguments with respect to the rest of the prior office action have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Claims 1-6 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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