Detailed Action
The present office action is in response to the remarks filed on 04 Mar 2026.
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 .
Status
Claims 37-39, 56, 59, 64, 66, 69, 73-74, 76, 78, 80, 82, and 128 of the pending application have been examined on the merits. Claims 1-3, 16-17, 20, 22, 26-27, 29, 31, 34, 36, 83-86, 94, 96-97, 99, 102, 104-108, 111-112, 129-130, 132, 134-135, 137, 140, 142-144, and 146-147 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 01 May 2024. Acknowledgement is made of the cancellation of claims 4-15, 18-19, 21, 23-25, 28, 30, 32-33, 35, 40-55, 57-58, 60-63, 65, 67-68, 70-72, 75, 77, 79, 81, 87-93, 95, 98, 100-101, 103, 109-110, 113-127, 131, 133, 136, 138-139, 141, and 145.
Priority
Applicants identify the instant application, Serial #: 18/286,615, filed 12 Oct 2023, as a National Stage Entry of International Patent Application #: PCT/US2022/24805, filed 14 Apr 2022, which claims priority from U.S. Provisional Application #s: 63/174,860, filed 14 Apr 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 01 May 2024, 01 Oct 2025, and 04 Mar 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election of Group I in the reply filed on 04 Mar 2026 is acknowledged. Applicant’s election of compound 247c (below) as the species of compound in the reply filed on 04 Mar 2026 is acknowledged.
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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)). A search for the elected species returned no prior art. Examiner expanded the Markush search to compound 232b (below) found in instant claim 82 and on pg. 496 of the specification:
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A search for this species returned prior art.
Claims 1-3, 16-17, 20, 22, 26-27, 29, 31, 34, 36, 83-86, 94, 96-97, 99, 102, 104-108, and 111-112 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 129-130, 132, 134-135, 137, 140, 142-144, and 146-147 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04 Mar 2026.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 37-39, 56, 59, 64, 66, 69, 73, 74, 76, 78, 80/37, and 128 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of rings A, B, C, and D in formula (II)
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are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The claims define ring A and B as “arylene or heteroarylene” where ring A is fused to ring B at two adjacent positions, ring C as a “bicyclic ring system”, and ring D as “aryl or heteroaryl”. The specification defines arylene groups to be diradicals of aryl groups which are defined as a term of art which includes monocyclic, bicyclic, and polycyclic aromatic hydrocarbon groups (pg. 16). Further, the specification further defines heteroarylene as diradicals of heteroaryl groups which are defined as a term of art which refers to monocyclic, bicyclic, and polycyclic aromatic groups with 3-12 atoms including one or more heteroatoms (pg. 17). The variability of the definitions for each of the rings in the claimed structure of formula II results in there being no shared structural similarity that a person of ordinary skill in the art would recognize. Further, based on the breadth of the structures claimed, the artisan would have no reasonable expectation of success that all compounds claimed would have the same use.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claims 80/40-80/55, 80/60-80/63, 80/65, 80/67-80/68, 80/70-80/72, 80/75, 80/77, and 80/79 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. Each of the claims listed above is dependent on a cancelled claim and is incomplete. 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 (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.
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.
Claim(s) 37-39, 56, 59, 64, 66, 69, 73-74, 76, 78, 80, 82, and 128 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/195720 (provided in IDS 03/04/26), hereinafter ‘720.
Applicant elected compound 247c in the reply filed on 04 Mar 2026 which is a species of formula (II):
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Examiner expanded the Markush search to include compound 232b (instant specification pg. 496):
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which is a species of formula (II) when ring AB is benzofuran, ring C is isoquinoline, J is CH2, K is O, D is phenyl, LD is CH2, R1 is H, and m, n, and p are 0. This species reads on the
‘720 teaches compounds that inhibit Factor D (pg. 1142-1150), including compound 87c which inhibits Factor D with an IC50 of greater than 10 µM (pg. 259; pg. 1144):
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‘720 further teaches pharmaceutical compositions comprising compounds of the reference and a pharmaceutically acceptable carrier (pg. 83). However, compound 87c differs from instant compound 232b in the attachment of the substituents to the benzofuran core and the position of attachment on the isoquinoline moiety.
MPEP § 2144.09(II) teaches, “compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2 groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.”
The person of ordinary skill in the art would modify the attachment position of the methoxy linker and the isoquinoline substituent of reference compound 87c, taught by ‘720, to facilitate a positional isomer which has a sufficiently close structural similarity that the person or ordinary skill in the art would have a presumed expectation of the compounds having similar properties. The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., they would be pharmacologically active Factor D inhibitors) with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compounds in view of the compound taught by ‘720.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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