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
This Office Action is responsive the Response to Election/Restriction filed 08/06/2026.
Claims 1-20 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group I, compounds and compositions thereof, and the species:
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in the replies filed on 07/20/2026 and 08/06/2026, is acknowledged.
The species is allowable over the prior art. The examination of the Markush claim has been extended. If a Markush grouping as set forth in a claim is proper and election of species has been required, the examiner must continue to search the species of the claim unless the claim has been found to be unpatentable over prior art. MPEP 803.02.
As detailed in the following prior art rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-16 are examined on the merits herein.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
In claims 1 and 7, in the definition of R7, -C(=O)NRaS(=O)pRc is repeated. The 2nd iteration of -C(=O)NRaS(=O)pRc, should be deleted.
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 1-15 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.
On pgs. 24-25 of the Specification, “alkyl” and “alkylene” are taught as substituted or unsubstituted. As such, it is not clear if the instantly claimed alkyl groups substituted with a chemical group(s), means that the alkyl group is either unsubstituted or substituted with only that chemical group(s), or if it is substituted with the claimed chemical group(s) and any other substituent.
In claim 1, for example, the following is stated:
-R1 is. . .C1-4 alkyl substituted with 0-5 halo or -OH
-R3 is. . .OC1-4 alkyl substituted with 0-5 halo
-R4 is. . . C1-4 alkyl substituted with 0-5 halo. . .or - OC1-4 alkyl substituted with 0-5 halo
-R6 is. . . C1-4 alkyl substituted with 0-2 halo or OH
-R7 is. . . C1-5 alkyl substituted with 0-1 R8 and 0-1 R9
-R8 is. . . C1-4 alkyl substituted with 0-3 halo or OH
-R13 is. . . C1-3 alkyl substituted with 0-2 R6 and 0-2 R7
-Ra/Rb/Rc is. . . C1-6 alkyl substituted with 0-5 Re
-Re is. . . C1-6 alkyl substituted with 0-5 Rg
-Rf is. . . C1-6 alkyl substituted with 0-1 -OC1-4 alkyl.
Further, since the instant specification defines alkyl and alkylene as substitute or unsubstituted. It is not clear if the alkyl group or alkylene group with 0 of the recited groups is unsubstituted or if it can be substituted by another group not specifically recited. For example in the phrase, “R1 is. . .C1-4 alkyl substituted with 0-5 halo or -OH,” and the C1-4 alkyl is substituted with 0 halo, must the C1-4 alkyl group be substituted with -OH, or is the C1-4 alkyl group unsubstituted or substituted with a group other than a halo or -OH. For further example, in the phrase “R3 is. . . O C1-4 alkyl substituted with 0-5 halo,” if the alkyl group is substituted with 0 halo, is the C1-4 alkyl unsubstituted or can it be further substituted with a substituent other than halo.
See also similar phrases in claim 2-15.
In view of compact prosecution, for the purpose of applying prior art, if an alkyl group comprises zero of the recited substituents, it is interpreted as unsubstituted or substituted with a group not recited in the claim. For example, in the phrase, “R1 is. . . C1-4 alkyl substituted with 0-5 halo or -OH,” if the C1-4 alkyl is substituted with 0 halo, it is interpreted as an unsubstituted C1-4 alkyl group or a C1-4 alkyl group substituted with a group other than halo or OH.
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 3-14 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.
-Claims 3 and 6, depend from claim 2, and depict,
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and
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, as A. However, claim 2 does not recite A as ,
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or
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. Though claim 2 does depict similar compounds, these compounds depict the double bond at a different location than that depicted in
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and
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. As such, claims 3 and 6, broaden the scope of the definition of A.
-Claims 3 and 6, depend from claim 2, and recite R6 is a C1-3 alkyl. However, claim 2 defines R6 as a C1-4 alkyl substituted with 0-2 halo or OH. Thus, R6, as defined by claim 2, must be substituted by either halo or OH. As such, claims 3 and 6 broaden the scope of the definition of R6. See also the definition of R6 in claim 4.
-Claim 4 depends from claim 3, which depends from claim 2, and defines R5 as
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. However, the definition of R5, including that of R6 and R7, which are substituents on the R5 heterocyclyl, do not recite =O as a substituent group on the R5 heterocyclyl. As such,
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, broadens the scope of the definition of R5 in claims 2 and 3.
-Claim 4 depends from claim 3, and recites R8 is a C1-4 alkyl. However, claim 3 defines R8 as a C1-4 alkyl substituted with 0-3 halo or OH. Thus, R8, as defined by claim 3, must be substituted by either halo or OH. As such, claim 4 broadens the scope of the definition of R8.
-Claim 6 depends from claim 2, and recites R6 is CN. However, claim 2 does not recite that R6 is CN. As such, claim 6 broadens the scope of the definition of R6.
-Claim 7 depends from claim 2, and recites R11 is -C(=O)NRaRa. However, claim 2 does not recite R11 is -C(=O)NRaRa. As such, claim 7 broadens the scope of the definition of R11.
-Claim 8 depends from claim 7 and recites Ra and Rb as C1-3 alkyl substituted with 0-5 Re. However, claim 7 recites that is C1-5 alkyl is substituted with 0-4 Re. As such, claim 8 broadens the scope of Re in the definition of Ra and Rb.
-Claims 9 and 13 depend from claim 7, and recite R6 is a C1-4 alkyl substituted with 0-1 OH. However, claim 7 defines R6 as a C1-4 alkyl substituted with 0-2 halo or OH. Thus, R6, as defined by claim 7, must be substituted by either halo or OH. As such, claims 9 and 13 broaden the scope of the definition of R6.
-Claims 10 and 12 depend from claim 7, and recite R6 is a C1-4 alkyl. However, claim 7 defines R6 as a C1-4 alkyl substituted with 0-2 halo or OH. Thus, R6, as defined by claim 7, must be substituted by either halo or OH. As such, claims 10 and 12 broaden the scope of the definition of R6.
-Claim 13 depends from claim 7, and recites Re is -S(=O)2C1-3alkyl. However, claim 7 does not define Re as such a group. As such, claim 13 broadens the scope of the definition of Re. See also claim 14.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2019/057969 to Merk (published 2019, IDS of 01/17/2025).
Regarding claim 1, Merk teaches:
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(pg. 33), which meets the limitations of instant Formula (I), when:
-instant A is a 5-membered heterocyclyl comprising two O’s,
-instant R1 is 0
-instant R2 is a bicyclic carbocyclyl
-instant R4 is a C3 alkyl substituted with 0 halo and a (=O)OH group (see the 112(b) rejection above and the interpretation of alkyl groups).
"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. See MPEP 2131.02.
Regarding claim 16, Merk teaches pharmaceutical compositions comprising its compounds and a pharmaceutically acceptable carrier.
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, 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.
Claims 1 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over WO2013/165606 to Marugan (published 2013, IDS of 01/17/2025).
Marugan teaches the following compounds:
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([0472]);;
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([0346], [0308]);
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;
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;
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;
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([0258], [0252]);
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;
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;
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, which meet the limitations of instant Formula (I) when:
R2 is a bicyclic carbocyclyl; phenyl substituted with 1 R5, a C6 carbocyclyl; a heterocyclyl (see the definition of heterocyclyl and carbocyclyl on pgs. 25-26 of the instant specification, wherein heterocyclyl is defined as monocyclic or bicyclic and as saturated, partially unsaturated, or fully saturated; and carbocyclyl is defined as saturated, partially unsaturated, unsaturated or aromatic).
R4 is a C1 alkyl substituted with 3 halo.
Regarding claim 1, Marugan differs from that of instant Formula (I) in instant claim 1 in that it does not teach A.
Marugan further teaches its compounds as generically having the structure:
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(pgs. 205-206, 215, 216, claims 71, 105, 113; [0041]), which meets the limitations of instant formula (I) when
-instant R4 is (R4)2,
-instant R2 is phenyl substituted with at least R5
-m, n, o, and p of Marugan are 0,
-X and Y of Marugan is O
-R8 and R9 of Marugan is H
-A can be a phenyl fused to a 5-membred heterocyclic ring, and
- R10 of Marugan is 0 and instant R1 is (R1)0.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the central phenyl ring of Examples 35, 39-42, 74, 78, or 148 of Marugan, to a bicyclic phenyl ring, to arrive at instant Formula (I). One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because Marugan teaches that at the position of the central phenyl ring, the ring can be phenyl or a phenyl fused to a 5-membered heterocyclic ring.
As such, an ordinary skilled artisan would have been motivated to make such a modification, to predictably arrive at a structurally and functionally similar compound that is effective for a method of treating a disease or condition mediated by a mammalian relaxin receptor 1 (pg. 196, claim 21).
Regarding claim 16, Marugan teaches a composition comprising its compounds and a pharmaceutically acceptable carrier (pg. 196, claim 20).
Free of the Prior Art
Claims 2-15 appear to be free of the prior art. The closest prior art is WO 2013/165606
to Marugan, which is discussed in the above prior art rejection. Marugan does not teach A as recited in instant claim 2, which is a distinct feature of the compounds of claims 2-15.
Additionally close prior art is WO2019057969 (IDS of 01/17/2025) to Merk, wherein Merk teaches:
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(pg. 33), which meets the limitations of instant Formula (I), when:
-instant A is a 5-membered heterocyclyl comprising two O’s,
-R1 is 0
-R2 is a bicyclic carbocyclyl.
However, Merk does not teach instant R2 as a phenyl group substituted by R5 and R3.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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 supervisor, James (Jim) 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.
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/LAUREN WELLS/Examiner, Art Unit 1622
