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 1-13, 15, 17, 19, 21, 22, 24, 25, 28, 29, 31, 32 and 35-59 are pending in the application. Claims 1, 5, 8, 10-13, 22, 32, 36, 39 and 57 are rejected. Claims 1, 13, 39 and 57 are objected to. Claims 2-4, 6, 7, 9, 15, 17, 19, 21, 24, 25, 28, 29, 31, 35, 37, 38, 40-56, 58 and 59 are withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of Group I, claims 1-13, 15, 17, 19, 21, 22, 24, 25, 28, 29, 31, 32, 35-39, and 57, and further elected species of Compound 74 (reproduced below) in the reply filed on February 27, 2026 is acknowledged.
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As per MPEP § 803.02(III), the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears to be free of the prior art. Therefore, according to MPEP § 803.02(III): should the elected species be found allowable over the prior art, the examination of the Markush claim will be extended. The prior art search will be extended to cover non-elected species or group of species that fall within the scope of a proper Markush grouping which includes the elected species. The prior art search will not be extended unnecessarily to cover all nonelected species, and need not be extended beyond a proper Markush grouping. However, if prior art is found that anticipates or renders obvious the Markush claims with respect to a nonelected species, the Markush claims shall be rejected and claims to the nonelected species held withdrawn from further consideration. Consequently, the prior art search was extended to include the following non-elected species that are NOT allowable over the prior art:
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,
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and
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, wherein A is methyl.
Claims 1, 5, 8, 10-13, 22, 32, 36, 39 and 57 read on the elected species. Claims 2-4, 6, 7, 9, 15, 17, 19, 21, 24, 25, 28, 29, 31, 35, 37, 38, 40-56, 58 and 59 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species. Note that contrary to Applicant’s assertions (see page 60 of Applicant’s Remarks dated February 27, 2026), claims 25, 29 and 31 do NOT read on Applicant’s elected species while claim 11 does read on Applicant’s elected species.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/015596, filed on February 8, 2022, which claims benefit of Provisional Application No. 63/147,710, filed on February 9, 2021.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on March 7, 2024 and February 27, 2026 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Objections
Claim 1, 13, 39 and 57 are objected to because of the following informalities:
Claim 1 should be amended to maintain consistency with the appropriate usage of a comma or a semicolon in the recited list of Markush alternatives for variable R1.
Claim 13 should be amended to remove the word “or” before “p-fluorophenyl” in the second to last line of the claim for sake of consistency.
Claim 39 should be amended to replace “a compound of claim 1” with -the compound of claim 1- for sake of consistency.
Claim 57 should be amended to replace “a compound of claim 10” with -the compound of claim 10- for sake of consistency.
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 1, 5, 8, 10, 12, 13, 22, 32, 39 and 57 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 recites the limitation “wherein when a group described above is said to be ‘substituted,’ it may be substituted with one or more substituents” (emphasis added) and is rejected as indefinite. It is unclear whether Applicant intended group substitution to be a requirement or to be optional as the expression “may be” implies a possibility. It is suggested Applicant replace the expression “may be” with the word -is- to overcome this issue of indefiniteness. Dependent claims 5, 8, 10, 12, 13, 22, 32, 39 and 57 do not correct this issue of indefiniteness and are likewise rejected.
Claim 10 recites the limitation “each R is independently H and substituted or unsubstituted C1-4 alkyl” (emphasis added) and is rejected as indefinite. It is unclear how variable R can simultaneously be both H and C1-4 alkyl. It is suggested Applicant amend claim 10 to replace the word “and” in the aforementioned limitation with a comma for sake of clarity and consistency. Dependent claims 10, 12, 13, 22, 32, and 57 do not correct this issue of indefiniteness and are likewise rejected.
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 22 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 22 recites “The compound of claim 10, wherein R2 is 2-pyrazyl, unsubstituted or substituted with....” (emphasis added). However, parent claim 10 does not provide for variable R2 being defined as an unsubstituted pyrazyl. Therefore, claim 22 fails to include all the limitations of parent claim 10. It is suggested Applicant cancel “unsubstituted” from the claim.
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
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, 5, 10-13, 36, 39 and 57 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Buhr et al. (PCT Publication No. WO 2012/110603 A1; August 23, 2012).
Buhr et al. teach Example Compound 226 and Example Compound 236 having the following chemical structures (see e.g., pages 44 and 45):
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.
Regarding instant claims 1, 10-13 and 57, the above Example Compound 226 is encompassed by variable definitions of the instantly claimed compound of Formula (I) (i.e., as recited in instant claim 1), wherein--- is a single or double bond; A is CR1, further wherein R1 is independently H or halogen (i.e., F); p is 0; R is absent; n is 0; m is 2; and R2 is heteroaryl (i.e., 3-pyridyl) substituted with C1 alkyl and Formula (Ia) (i.e., as recited in instant claim 10), wherein n is 1; R1 is halogen (i.e., F); and R2 is 3-pyridyl substituted with substituted C1 alkyl. Regarding instant claim 39, Buhr et al. teach “optionally one or more further pharmacologically acceptable carriers and/or auxiliary substances and/or solvents.” See e.g., page 84.
Regarding instant claims 1, 5, 36 and 39, the above Example Compound 236 is encompassed by variable definitions of the instantly claimed compound of Formula (I), wherein --- is a single or double bond; A is CR1, further wherein R1 is independently H or halogen (i.e., F); p is 0; R is absent; n is 0; m is 2; and R2 is unsubstituted heteroaryl (i.e., 2-pyridyl). Example Compound 236 of the prior art also corresponds to Compound 135 as recited in instant claim 36. Regarding instant claim 39, Buhr et al. teach “optionally one or more further pharmacologically acceptable carriers and/or auxiliary substances and/or solvents.” See e.g., page 84.
Claim Rejections - 35 USC § 103
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.
Claim 8 is rejected under 35 U.S.C. § 103 as being unpatentable over Buhr et al. (PCT Publication No. WO 2012/110603 A1; August 23, 2012).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
The broadest disclosure of the prior art invention by Buhr et al. is drawn to the following genus (see e.g., page 8):
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.
Buhr et al. further teach the following species (i.e., Example Compound 236) as representative of the above genus (see e.g., page 45):
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.
The above Example Compound 236 is encompassed by variable definitions of the instantly claimed compound of Formula (I) (as recited in instant claim 1), wherein --- is a single or double bond; A is CR1, further wherein R1 is independently H or halogen (i.e., F); p is 0; R is absent; n is 0; m is 2; and R2 is unsubstituted heteroaryl (i.e., 2-pyridyl).
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claim 8, the prior art Example Compound 236 does not correspond to the instantly claimed compound of Formula (I) wherein “R2” is a substituted 2-pyridyl as recited in instant claim 8. However, Buhr et al. teach that the position corresponding to variable “R8” (which parallels the position for instant variable “R2”) of the aforementioned prior art genus can be an “optionally substituted heterocyclyl.” See e.g., page 9. Buhr et al. further teach that a “[p]articularly preferred heterocyclyl includes...pyridine-2-yl.” See e.g., page 18. Furthermore, Buhr et al. teach “methy[l]pyridinyl” as a preferred “heterocyclyl group substituted by alkyl.” See e.g., page 19.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Therefore, considering that Buhr et al. teach methylpyridinyl as an alternative for the position corresponding to variable “R8” of the prior art genus, it would have been obvious to a person of ordinary skill in the art to substitute a hydrogen from the 2-pyridyl moiety of Example Compound 236 with a methyl group and arrive at the invention of instant claim 8 (e.g.,
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, wherein A is methyl). “It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results.” In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978). At least in the interest of providing additional sulfonaminoquinoline hepcidin antagonist compounds, a person of ordinary skill would have been motivated to modify the prior art Example Compound 236 and arrive at the instantly claimed invention.
Allowable Subject Matter
Claims 22 and 32 are allowable over the prior art. Claims 22 and 32 would be allowable if a) rewritten in independent form including all of the limitations of the base claim and any intervening claims and b) amended to address 35 U.S.C. § 112 issues as discussed above.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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