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 .
Election/Restrictions
Applicant's election with traverse of Group I and ABX341 in the reply filed on 5/11/2026 is acknowledged. The traversal is on the ground that “the PTO has not established that it would pose an undue burden to examine the full scope of the application.” This is not found persuasive because the Office must explain why there would be a serious search and/or examination burden on the examiner if restriction is not required when a restriction is made under 35 U.S.C. 121. The instant restriction was made under 37 C.F.R. 1.499, thus the aforementioned showing is not required by the Office.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5, 7, 10, 20, and 21 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and III, and there being no allowable generic or linking claim.
Status of Claims
Withdrawn: 5, 7, 10, 20, 21
Examined Herein: 1-4, 6, 8, 9, 11-19
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in EP20207224.5 on 11/12/2020 and PCT/EP2021/081404 on 11/11/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/24/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 5/11/2023 are accepted.
Claim Rejections - 35 USC § 102
(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 1-3, 8, 9, 11, and 17-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bohnke (US 2023/0072421 A1, Filed 7/24/2020).
With respect to claim 1-3, Bohkne discloses the following compound of Formula (I):
PNG
media_image1.png
996
1326
media_image1.png
Greyscale
[Bohkne, 1271]
wherein:
C is DOTA
L is a C5 heteroaryl and contains one N heteroatom (pyridyl)
k is 1
m is 1
R1 is naphthyl
p is 0 (X, n, and R2 are absent), thus meeting the limitations of claims 1-3.
With respect to claim 8, Bohkne discloses R1 is naphthyl and m is 1, thus meeting the limitations of claim 8.
With respect to claim 9, Bohkne discloses the compound below, thus meeting the limitations of claim 9:
PNG
media_image2.png
331
651
media_image2.png
Greyscale
.
With respect to claim 11, Bohkne discloses a metal complex comprising a radionuclide and the aforementioned compound, thus meeting the limitations of claim 11.
With respect to claim 17, Bohkne discloses a metal complex comprising a radionuclide and the aforementioned compound, thus meeting the limitations of claim 17. The limitation “for use in a method of imaging in a patient” recites an intended use but does not result in a structural difference between the claimed invention and the prior art and, therefore, does not patentably distinguish the claimed invention from the prior art.
With respect to claim 18, Bohkne discloses a metal complex comprising a radionuclide and the aforementioned compound, thus meeting the limitations of claim 18. The limitation “for use in a method of diagnosing a cancer and/or metastasis thereof, optionally selected from the group of cancers that are positive for expression of PSMA, further optionally prostate cancer” recites an intended use but does not result in a structural difference between the claimed invention and the prior art and, therefore, does not patentably distinguish the claimed invention from the prior art.
With respect to claim 19, Bohkne discloses a metal complex comprising a radionuclide and the aforementioned compound, thus meeting the limitations of claim 19. The limitation “for use in a method for treating cancer and/or metastasis thereof, optionally selected from the group of cancers that are positive for expression of PSMA, further optionally prostate cancer” recites an intended use but does not result in a structural difference between the claimed invention and the prior art and, therefore, does not patentably distinguish the claimed invention from the prior art.
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.
Claims 1-4, 6, 8, and 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Benesova (US 2021/0009715 A1, Filed 5/24/2018).
With respect to claim 1-4, and 6, Benesova discloses the following compound of Formula (I):
PNG
media_image3.png
1004
1875
media_image3.png
Greyscale
[Benesova, 0246, (7a)(i)]
wherein:
C is DOTA
L is a C6 aryl (cyclohexane)
k is 1
m is 1
R1 is naphthyl
p is 1
n is 2
X is NH
R2 is propyltoulene-C(O)-.
With respect to claim 8, Benesova discloses R1 is napthyl and m is 1. [Benesova, 0246, (7a)(i)]
With respect to claim 11, Benesova discloses a metal complex comprising a radionuclide and the aforementioned compound. [Benesova, 0270-0272, 0277, 0278]
With respect to claim 12, Benesova discloses the radionuclide is 111In, 90Y, 68Ga, 177Lu, 99mTc, 64Cu, 67Cu, 153Gd, 157Gd, 213Bi, 225Ac, or 212Pb. [Benesova, 0270-0272, 0277, 0278]
With respect to claim 13, Benesova discloses the radionuclide is 177Lu. [Benesova, 0270-0272, 0277, 0278]
With respect to claim 14, Benesova discloses the radionuclide is 68Ga. [Benesova, 0270-0272, 0277, 0278]
With respect to claim 15, Benesova discloses the radionuclide is 225Ac. [Benesova, 0270-0272, 0277, 0278]
With respect to claim 16, Benesova discloses a pharmaceutical composition comprising a metal complex comprising a radionuclide and the aforementioned compound. [Benesova, 0270-0272, 0277- 0279]
With respect to claim 17, Benesova discloses a metal complex comprising a radionuclide and the aforementioned compound, thus meeting the limitations of claim 17. The limitation “for use in a method of imaging in a patient” recites an intended use but does not result in a structural difference between the claimed invention and the prior art and, therefore, does not patentably distinguish the claimed invention from the prior art.
With respect to claim 18, Benesova discloses a metal complex comprising a radionuclide and the aforementioned compound, thus meeting the limitations of claim 18. The limitation “for use in a method of diagnosing a cancer and/or metastasis thereof, optionally selected from the group of cancers that are positive for expression of PSMA, further optionally prostate cancer” recites an intended use but does not result in a structural difference between the claimed invention and the prior art and, therefore, does not patentably distinguish the claimed invention from the prior art.
With respect to claim 19, Benesova discloses a metal complex comprising a radionuclide and the aforementioned compound, thus meeting the limitations of claim 19. The limitation “for use in a method for treating cancer and/or metastasis thereof, optionally selected from the group of cancers that are positive for expression of PSMA, further optionally prostate cancer” recites an intended use but does not result in a structural difference between the claimed invention and the prior art and, therefore, does not patentably distinguish the claimed invention from the prior art.
Benesova does not disclose L is a C1-C5 heteroaryl containing one, two, three, or four heteroatoms, each independently selected from N, O, or S, or L is isoxazolyl, pyridyl, thiazolyl and thiophenyl, or R2 is aryl, aryl-C(O)-, or heteroaryl-C(O)-.
However, with respect to claim 1-4, and 6, Benesova discloses the aforementioned compound is a species of General Formula (1a):
PNG
media_image4.png
624
513
media_image4.png
Greyscale
[Benesova, 0078]
Linker:
PNG
media_image5.png
180
690
media_image5.png
Greyscale
[Benesova, 0087]
wherein:
D is a chelator [0080]
a is 0 [0093]
spacer is a C-N bond [0086]
X is O [0081, 0089]
Y is a linear C3 alkyl [0083]
R1 is H [0082]
R2 is C1 hydrocarbyl (methyl) [0082]
Q is C6 cycloalkyl (cyclohexane) [0090]
W is –(CH2)c-aryl [0091]
c is 1 [0091-0092]
b is 3 [0093]
R3 is CO2H [0085]
R4 is CO2H [0085]
R5 is CO2H [0085]
Benesova further discloses Q may preferably be a substituted or unsubstituted C5-C14 aryl, alkylaryl, or cycloalkyl. [Benesova, 0090] Bensova discloses suitable substituted cycloalkyls (or heterocycloalkyls) include thiophenyl, pyrrolyl, pyrrolinyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, oxazolyl, isoxazolyl, thiazolyl, thiazolinyl, isothiazolyl, thiadiazolyl, oxadiazolyl, pyridyl, pyrimidinyl, pyridazinyl, or pyrazinyl. [Benesova, 0025]
Moreover, Benesova discloses Y may be a single bond. [Benesova, 0083]
Modifying the compound disclosed by Benesova by replacing cyclohexane (Q) with thiophenyl, pyrrolyl, pyrrolinyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, oxazolyl, isoxazolyl, thiazolyl, thiazolinyl, isothiazolyl, thiadiazolyl, oxadiazolyl, pyridyl, pyrimidinyl, pyridazinyl, or pyrazinyl, and by replacing the linear C3 alkyl (Y) with a single bond, results in the compound of claim 1, 2, 3, 4, and/or 6, wherein:
L is a C5 heteroaryl substituted with N, O, or S, and
R2 is aryl-C(O)- substituted with one C1 alkyl group.
It would be obvious to one of ordinary skill in the art to modify the compound disclosed by Benesova by replacing cyclohexane (Q) with thiophenyl, pyrrolyl, pyrrolinyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, oxazolyl, isoxazolyl, thiazolyl, thiazolinyl, isothiazolyl, thiadiazolyl, oxadiazolyl, pyridyl, pyrimidinyl, pyridazinyl, or pyrazinyl and have a reasonable expectation of success. Benesova discloses a compound comprising a moiety represented by “Q,” wherein the moiety is cyclohexane. However, Benesova further discloses Q may be a substituted or unsubstituted C5-C14 aryl, alkylaryl, or cycloalkyl, including thiophenyl, pyrrolyl, pyrrolinyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, oxazolyl, isoxazolyl, thiazolyl, thiazolinyl, isothiazolyl, thiadiazolyl, oxadiazolyl, pyridyl, pyrimidinyl, pyridazinyl, or pyrazinyl. In view of this express teaching, it is reasonable to expect the “Q” moiety may be thiophenyl, pyrrolyl, pyrrolinyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, oxazolyl, isoxazolyl, thiazolyl, thiazolinyl, isothiazolyl, thiadiazolyl, oxadiazolyl, pyridyl, pyrimidinyl, pyridazinyl, or pyrazinyl. One would have been motivated to do so because the selection of a known compound based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Therefore, the selection of thiophenyl, pyrrolyl, pyrrolinyl, imidazolyl, pyrazolyl, triazolyl, tetrazolyl, oxazolyl, isoxazolyl, thiazolyl, thiazolinyl, isothiazolyl, thiadiazolyl, oxadiazolyl, pyridyl, pyrimidinyl, pyridazinyl, or pyrazinyl based on its suitability as a substituted or unsubstituted C5-C14 aryl, alkylaryl, or cycloalkyl for its intended use as the “Q” moiety in the compound disclosed by Benesova is prima facie obvious.
It would be obvious to one of ordinary skill in the art to modify the compound disclosed by Benesova by replacing the linear C3 alkyl (Y) with a single bond and have a reasonable expectation of success. Benesova discloses a compound comprising a moiety represented by “Y,” wherein the moiety is a linear C3 alkyl. However, Benesova further discloses Y may be a single bond. In view of this express teaching, it is reasonable to expect the “Y” moiety may be a single bond. One would have been motivated to do so because the selection of a known substituent based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Therefore, the selection of a single bond based on its suitability as a substituent for its intended use as the “Y” moiety in the compound disclosed by Benesova is prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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