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 .
Current Status
This action is responsive to the amended claims of 10/28/2025. Claims 1, 6, 8-10, 12, 14-16, 20-23, 25-29, 31, 35-42, 45-47, 49-53, 55, and 57-60 are pending. Claims 6, 12, 14-15, 23, 26, 28, 31, 35-41, 45-47, 49-51, 53, 55, and 57-60 are withdrawn. Claims 1, 8-10, 16, 20-22, 25, 27, 29, 42, and 52 have been examined on the merits.
Election/Restrictions
The amendments of 10/28/2025 have overcome the previous prior art rejections of 04/28/2025, thus, the Markush search has been expanded to the following species:
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The expanded species reads on claims 1, 8-10, 16, 20-22, 25, 27, 29, 42, and 52.
Claims 6, 12, 14-15, 23, 26, 28, 38-41, 45, 49-51, 53, 55, and 57-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 06/26/2023.
Claims 31, 35-37, and 46-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/26/2023.
Priority
The effective filing date remains 08/24/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/25/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the amendments and remarks of 10/28/2025, no new matter is found.
The objection the specification is withdrawn since Applicant has fixed the errors.
The objections to the claims are withdrawn since Applicant has amended in line with Examiner’s suggestions.
The 112(b) rejections of claims 1, 8-10, 20-21, 29, 42, and 45 are withdrawn:
Claim 1 has been amended to strike “including”; Applicants have clarified through argumentation the meaning of claim 20 – Examiner agrees within the context of parent claim 1 the meaning is clear; Applicants have clarified through argumentation that the -C6H5 moiety of claim 42 is a phenyl which does have support in the parent claim. Examiner notes the withdrawn claims which contained probable 112b rejections have also been addressed by Applicant (see ¶35 of prev. action).
The 112(d) rejections of claims 20 and 42 are withdrawn for the reasons stated in the above paragraph.
The 102 rejection of claims 1, 8-10, 20-21, 42, and 45 over TSUCHIYA is withdrawn because Applicant has amended claim 1 to exclude compounds wherein R1 is an alkyl substituted with a heteroatom that is S.
The 103 rejection of claims 1 and 29 over TSUCHIYA in view of CHAUDHARI is withdrawn since the compound of TSUCHIYA no longer reads on claim 1.
Response to Amendment
Claim Objections
Claim 52 is objected to because of the following informalities: the claim broadly recites wherein replacement of a carbon atom in a ring structure of the formula of claim 1 results in moieties containing at least 2x as many C atoms as heteroatoms. This recitation is understood to refer to any of the ring structures that claim 1 formula (Ib) defines as eligible for replacement of a C atom with a heteroatom. However, it is preferred if Applicant define which of the variables (e.g., R1) the claim is limiting, especially if Applicant did not mean for the claim to be understood so broadly. Appropriate correction is required.
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.
Claims 25 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.
Note: claims 25 and 27 were previously withdrawn as being drawn to an unelected species. Due to the amendment and resulting Markush search extension, the claims are now examined.
Claim 25 recites structures (I-1) and (I-4) which contain two separate variables Z1 and Z2 both of which are singly bound to the core structure: e.g.,
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. There is insufficient antecedent basis for these limitations in the claim. Claim 25 states Z1 and Z2 are defined as in formula (Ib) of claim 1; however, claim 1 does not recite two singly bound variables Z1 and Z2. Claim 1 recites Z1/2 with a double bond to the core structure:
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. Since the structures and recited variables do not match between the parent and dependent claim, the metes and bounds of the claim 25 are undefined rendering the claim indefinite.
For examination purposes, variables Z1 and Z2 are understood as Z1/2 as recited in parent claim 1.
Claims 25 further recites “including” twice in the definition of (I-4). It is not clear whether the limitations following including are required by the claim or simply exemplary embodiments. It is also unclear if “including” substituents and replacements with heteroatoms means carbons in substituents and heteroatoms which replaced carbons are added to the total carbon count or not. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 27 also recites “including” twice in lines 3-4. For the reasons stated above, ¶20, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim Rejections - 35 USC § 112(d)
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 25 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 25 recites the variables Z1 and Z2, as described in ¶19 above, these variables are not recited in claim 1. Since claim 25 relies on claim 1 to define Z1 and Z2 and claim 1 does not define these variables, Z1 and Z2 are understood as outside of the scope of claim 1. Thus, claim 25 does not properly further limit formula (Ib) of 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.
Claims 1, 8-10, 16, 20-22, 25, 27, 29, 42, and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PITTS (WO 03/091252).
Regarding claims 1, 8-10, and 52, PITTS teaches a compound
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(Pg. 58 Examples 11-23) wherein R25 is
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(Pg. 59 Example 17). Thus, PITTS teaches the compound
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wherein:
R1 is C10 bicycloalkyl (spiro systems are included in the instant definition – see instant claim 1 Pg. 5 ¶2) wherein the cycle is substituted with 4 instances of =O and contains 3 N heteroatoms in replacement of 3 carbon atoms – this replacement results in a moiety that contains at least the same number of C atoms as heteroatoms (i.e., 7 C atoms vs. 3 N atoms – see instant claim 52);
R2-R5 are each H;
X1-X4 are CR11-CR14 wherein R11-R14 are each H;
R6 and R7 are each H;
R8 is H; and
Z1/2 is =O.
Regarding claim 16, the compound of PITTS above teaches wherein R1 is selected from a bicyclic structure. Due to the use of “or” in the instant claim, PITTS reads on embodiment (ii).
Regarding claim 20, the compound of PITTS above teaches wherein R1 is selected from a moiety containing 7 carbons. Thus, it reads on the 4, 6, and 7 or more carbons recited in the instant claim.
Regarding claims 21-22, the compound of PITTS above teaches wherein R1 contains 3 (i.e., one or more) heteroatoms N in replacement of carbon atoms in R1. Further, this R1 is a bicyclic structure and contains a bicyclic structure (i.e., it reads on both embodiments of instant claim 22).
Regarding claim 25, the compound of PITTS above falls under formula (I-4) when it is understood in context of parent claim 1 (see 112b above – Z1 and Z2 are understood as Z1/2). R1 is a bicycle containing six or more carbons – 7 carbons after replacements with heteroatoms N and, if including the heteroatoms, 10 carbon atoms.
Regarding claim 27, the compound of PITTS above teaches wherein R1 is bicyclic and contains six or more carbons – 7 carbons after replacements with heteroatoms N and, if including the heteroatoms, 10 carbon atoms.
Regarding claim 29, PITTS further teaches a pharmaceutical composition thereof further comprising a pharmaceutically acceptable vehicle or carrier (Pg. 73 claims 11-12). PITTS further teaches administration to a patient in need (Pg. 7 Lines 17-20), thus, Examiner understands the pharmaceutical composition as suitable for human/veterinary medicine.
Regarding claim 42, the compound of PITTS above teaches wherein R11-R14 are each H. Due to the use of “and/or” in the claim, the embodiments are read in the alternate “or” and the compound of PITTS reads on the first embodiment.
Conclusion
Claims 1, 8-10, 16, 20-22, 25, 27, 29, 42, and 52 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and may be utilized in a future Markush search extension. It appears multiple species of at least claim 28 are known: see CAS RN 1546814-66-7 entered in STN 17 Feb. 2014 corresponds to instant XPF-0001, CAS RN 1156736-15-0 entered in STN 14 June 2009 corresponds to instant XPF-0002, and CAS RN 1156738-04-3 entered in STN 14 June 2009 corresponds to instant XPF-0003.
Further, newly filed (08/22/2025) application no. 19/308,064 claim 9 recites Tables 4-5, 8-10, 13-15, 18-20, 23, and 26-28 with substantial overlap in species recited within the same Tables of instant claim 28. If claim 28 were not withdrawn currently, the claim would be subject to a provisional non-statutory double patenting rejection. The co-pending application does not recite any species of instant claim 1 and differs in scope (e.g., Z1 and Z2 are recited as separate entities rather than the instant Z1/2).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625