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 .
Status of Application
Claims 18-36 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Claim Rejections - 35 USC § 112
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 18-26, 28, and 30-35 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 18, 22, 22, 24, 26, 28, 31, and 34-35 recites the broad recitation before the terms “preferably”, and the claim also recites “preferably…” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 30-33 recites the broad recitation before the term “in particular”, and the claim also recites “in particular…” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 18 recites the limitation "the structure X1" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the structure X1” to “a structure X1”.
Claim 19 recites the limitation "the structure (I)" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the structure (I)” to “a structure (I)” or “structure (I)”.
Claim 20 recites the limitation "the structure" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the structure” to “a structure”.
Claim 20 recites the limitation ”the group” in line 5. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the group” to “a group”.
Claim 21 recites the limitation “the group” in line 3. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the group” to “a group”.
Claim 22 recites the limitation “the group” in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the group” to “a group”.
Claim 23 recites the limitation "the structure" in line 3. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the structure” to “a structure”.
Claim 23 recites the limitation “the group” in line 5. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the group” to “a group”.
Claim 24 recites the limitation "the structure" in line 3. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the structure” to “a structure”.
Claim 24 recites the limitation “the group” in line 5. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the group” to “a group”.
Claim 25 recites the limitation "the structure" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the structure” to “a structure”.
Claim 25 recites the limitation “the group” in lines 5 and 7 and 9. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the group” to “a group”.
Claim 26 recites the limitation "the structure" in line 1 and 3. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the structure” to “a structure”.
Claim 26 recites the limitation "the range" in line 12-13. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the range” to “a range”.
Claim 28 recites the limitation “the group” in lines 1 and 5. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to amend “the group” to “a group”.
Claim Interpretation
Claims 18, 22, 22, 24, 26, 28, 31, and 34-35 recite “preferably” in the claim language. The examiner notes that the phrases following “preferably” are narrower limitations of the claim limitations. In these cases, the examiner notes that preferably is a preference and not a requirement language. Therefore, for the purposes of examination, the examiner interprets the narrower embodiments following the terms preferably as merely exemplary language of the conditions and not limiting the claim. Therefore, any prior art reading on the broader limitation reads on the claim regardless as to whether the prior art recites the narrower limitations.
Claims 30-33 recite “in particular” in the claim language. The examiner notes that the phrases following “in particular” are narrower limitations of the claim limitations. However, “in particular” is exemplary language and does not further limit the claim. Therefore, for the purposes of examination the examiner interprets any prior art reading on the broader limitations without “in particular” as reading on the claim regardless as to whether the prior art recites the “in particular…” phrases.
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.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin, K-S.; et al., WO 2020/210909 A1 (as cited in the IDS filed on 11/08/2024).
Lin, K-S., et al. (hereafter referred to as Lin) is drawn to radiolabeled compounds for diagnosis or treatment of PSMA expressing cancer (title; abstract). Lin teaches PSMA is a transmembrane protein that catalyzes the hydrolysis of N-acetyl-aspartylglutamate to glutamate and N-acetylaspartate (pg 1, para [0002], lines 1-2) and it is not expressed in most normal tissues but is overexpressed in prostate tumors and metastases (pg 1, para [0002], lines 2-4) and PSMA-targeting endoradiotherapeutic agents are well studied (pg 1, para [0003], lines 1-13). Lin teaches a compound according to general Formula I, shown below) wherein R1a, R1b, and R1c are independently -CO2H, and other options, R2 is a linear or branched cyclic or acyclic, and /or aromatic or non-aromatic C1-C20 alkylenyl or alkenylenyl, or a linear or branched , cyclic or acyclic, and/or aromatic or non-aromatic X2-X20 heteroalkylenyl or heteroalkenylenyl, R3 is -O-, -S-, -S(O)-, -NHC(O)-, -C(O)NH- or other group, R4 is a group which may have multiple aromatic rings; R5 and R6 are independently hydrogen or methyl; Xaa1 is an amino acid of formula -N(R8)R9C(O)-, wherein each R8 is independently hydrogen or methyl and wherein each R9 is independently a linear or branched, cyclic or acyclic, and/or aromatic or non-aromatic C1-C20 alkylenyl, alkenylenyl or alkynylenyl or a linear or branched, cyclic or acyclic, and/or aromatic or non-aromatic X2-X20 heteroalkylenyl, heteroalkenylenyl or heteroalkynylenyl; and Rx is a radiolabeling group independently selected from a radiometal and chelator (pg 2, para [0006]; pg 3, para [0006]). Lin teaches PET/CT, SPECT/CT imaging and biodistribution (pg 43, para [00112], lines 1-4; pg 43, para [00113], lines 1-8; pg 44, para [00114], lines 1-15; pg 44, para [00115], lines 1-8).
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As to claim 18, Lin teaches a PSMA binding ligand (pg 2, para [0006], Formula (1); pg 37, para [0085], lines 1-2) comprising a PSMA binding motif Q, where instant claim Q is equivalent to the PSMA binding motif structure (pg 2, para [0006], Formula (1); pg 37, para [0085], lines 1-2); and a chelator residue A, where instant claim A is equivalent to prior art “RX” (pg 2, para [0006], lines 14; pg 3, para [0006], lines 1-3) linked via at least one linker LAQ comprising at least one N-alkylated amino acid X1, where instant claim “X1” is equivalent to prior art “Xaa1” (pg 2, para [0006], Formula (1); pg 2, para [0006], lines 10-11).
As to claim 19, Lin teaches a PSMA binding ligand having the structure A-LAQ-Q, reproduced and annotated below (pg 2, para [0006], Formula (1)).
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As to claim 20, Lin teaches a PSMA binding ligand, Q, having the structure shown below, wherein R1 is H, where R2, R3, and R4 are independently -CO2H, where instant claim R1 is shown as H in Formula I of Lin, and where instant claim R2, R3, and R4 correspond to prior art R1b, R1a, and R1c respectively, and where prior art R2 is a linear C4 alkylenyl, and R3 is a -NHC(O)- relevant part reproduced below (pg 2, para [0006], Formula (I) and lines 1-5; pg 15, para [0053], lines 1-3, Formula (II)).
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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) 21-25 and 27-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin, K-S.; et al., WO 2020/210909 A1 (as cited in the IDS filed on 11/08/2024).
Lin, K-S., et al. (hereafter referred to as Lin) is drawn to radiolabeled compounds for diagnosis or treatment of PSMA expressing cancer (title; abstract). Lin teaches PSMA is a transmembrane protein that catalyzes the hydrolysis of N-acetyl-aspartylglutamate to glutamate and N-acetylaspartate (pg 1, para [0002], lines 1-2) and it is not expressed in most normal tissues but is overexpressed in prostate tumors and metastases (pg 1, para [0002], lines 2-4) and PSMA-targeting endoradiotherapeutic agents are well studied (pg 1, para [0003], lines 1-13). Lin teaches a compound according to general Formula I, shown below) wherein R1a, R1b, and R1c are independently -CO2H, and other options, R2 is a linear or branched cyclic or acyclic, and /or aromatic or non-aromatic C1-C20 alkylenyl or alkenylenyl, or a linear or branched , cyclic or acyclic, and/or aromatic or non-aromatic X2-X20 heteroalkylenyl or heteroalkenylenyl, R3 is -O-, -S-, -S(O)-, -NHC(O)-, -C(O)NH- or other group, R4 is a group which may have multiple aromatic rings; R5 and R6 are independently hydrogen or methyl; Xaa1 is an amino acid of formula -N(R8)R9C(O)-, wherein each R8 is independently hydrgoen or methyl and wherein each R9 is independently a linear or branched, cyclic or acyclic, and/or aromatic or non-aromatic C1-C20 alkylenyl, alkenylenyl or alkynylenyl or a linear or branched, cyclic or acyclic, and/or aromatic or non-aromatic X2-X20 heteroalkylenyl, heteroalkenylenyl or heteroalkynylenyl; and Rx is a radiolabeling group independently selected from a radiometal and chelator (pg 2, para [0006]; pg 3, para [0006]). Lin teaches PET/CT, SPECT/CT imaging and biodistribution (pg 43, para [00112], lines 1-4; pg 43, para [00113], lines 1-8; pg 44, para [00114], lines 1-15; pg 44, para [00115], lines 1-8).
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As to claim 21, Lin teaches a PSMA binding ligand (pg 2, para [0006], Formula (1); pg 37, para [0085], lines 1-2) comprising a PSMA binding motif Q, where instant claim Q is equivalent to the PSMA binding motif structure (pg 2, para [0006], Formula (1); pg 37, para [0085], lines 1-2); and a chelator residue A, where instant claim A is equivalent to prior art “RX” (pg 2, para [0006], lines 14; pg 3, para [0006], lines 1-3) linked via at least one linker LAQ comprising at least one N-alkylated amino acid X1, where instant claim “X1” is equivalent to prior art “Xaa1” (pg 2, para [0006], Formula (1); pg 2, para [0006], lines 10-11) and Lin teaches RX, which is equivalent to instant claim “A”, is a chelator residue DOTA (pg 16, para [0057], lines 1-6).
Lin does not expressly teach a single embodiment comprising all the features of the claimed product. However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments of a PSMA binding motif, Q; a chelator residue, A, linked via at least one linker, LAQ comprising at least one N-alkylated amino acid X1 taught by Lin as a skilled artisan recognizes that these claim elements are known in the art. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the compounds of Lin to include various options for the chelator as taught by elsewhere within Lin because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a PSMA binding ligand with DOTA as the chelator.
A person of ordinary skill in the art would have had a reasonable expectation of success in having a chelator as DOTA because the prior art of Lin disclosed DOTA on PSMA binding ligands (pg 55, Figure 1) and disclosed that RX can be chelating moieties such as DOTA (pg 2, para [0006], line 14; pg 3, para [0006], lines 1-3; pg 16, para [0057], lines 1-13).
The skilled artisan would have been motivated to combine DOTA with the PSMA binding ligand because the chelator enables a radiotherapeutic or imaging radioisotope to be chelated to the PSMA binding ligand enabling targeted delivery to the tumor and either imaging or treating the tumor. Therefore, it would have been prima facie obvious to combine the teachings within Lin.
As to claim 22, Lin teaches A is a chelator residue having a structure shown below, in part (pg 55, Figure 1, chelator section).
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As to claim 23, Lin teaches a PSMA binding ligand having the structure A-LAQ-Q, reproduced and annotated below (pg 2, para [0006], Formula (1)).
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The prior art teaches that there are 0 to 4 amino acid building blocks which overlaps with the claimed range of at least 1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). And Lin teaches Xaa1 is an amino acid of formula -N(R8)R9C(O)- (pg 2, para [0006], lines 10-14) which is equivalent to the structure of ASa (reproduced below) when R8 is hydrogen (pg 2, para [0006], lines 10-11). And Lin teaches wherein Q1, which is equivalent to the prior art R9, is aryl (pg 2, para [0006], lines 10-14).
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As to claim 24, Lin teaches the linker LAQ comprises at least one amino acid building block ASb wherein ASb is -NH-CH2-Q2-C(O)-, wherein Q2 is cycloalkyl, reproduced and annotated below (pg 15, para [0053], Formula (II)).
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As to claim 25, Lin teaches PSMA binding ligand having the structure (Ia) wherein R1 is H; R2, R3, and R4 are -CO2H; Q1 is alkylaryl; Q2 is cycloalkyl; and q is 1, reproduced and annotated below (pg 15, para [0053], Formula (II)). Regarding the range of “q”, when, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art. See MPEP 2131.03(I). Lin teaches –(X1)n1-, which is equivalent to “Xaa1”, is -N(CH3)-CH2-C(=O)- (pg 2, para [0006], lines 10-11; pg 9, para [0035], lines 1-2 and pg 10, para [0035], line 2) and n1 is from 0-4 (pg 15, para [0053], formula (II)). The claimed range of 1-25 overlaps with the prior art range of 0-4. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
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As to claim 27, Lin teaches a complex comprising a radionuclide (pg 12, para [0038], line 16; pg 23, para [0059], lines 1-2 and lines 13-18; pg 23, para [0060], lines 1-4) and Lin teaches a PSMA binding ligand (pg 2, para [0006], Formula (1); pg 37, para [0085], lines 1-2) comprising a PSMA binding motif Q, where instant claim Q is equivalent to the PSMA binding motif structure (pg 2, para [0006], Formula (1); pg 37, para [0085], lines 1-2); and a chelator residue A, where instant claim A is equivalent to prior art “RX” (pg 2, para [0006], lines 14; pg 3, para [0006], lines 1-3) linked via at least one linker LAQ comprising at least one N-alkylated amino acid X1, where instant claim “X1” is equivalent to prior art “Xaa1” (pg 2, para [0006], Formula (1); pg 2, para [0006], lines 10-11) and Lin teaches RX, which is equivalent to instant claim “A”, is a chelator residue DOTA (pg 16, para [0057], lines 1-6).
As to claim 28, Lin teaches the radionuclide is 177Lu (pg 47, para [00131], lines 1-2; pg 53, claim 27).
As to claim 29, Lin teaches a pharmaceutical composition comprising the PSMA binding ligand (pg 5, para [0022], lines 1-7; pg 34, para [0078], lines 1-3).
As to claim 30, Lin teaches a method of treating PSMA expressing cancer comprising administering to a subject in need the PSMA binding ligand (pg 34, para [0078], lines 1-7).
As to claim 31, Lin teaches a method for diagnosing PSMA expressing cancer using a diagnostic method comprising the PSMA binding ligand (pg 4, para [0017], lines 1-3; pg 33, para [0076], lines 1-10; pg 43, para [00112], lines 1-4; pg 43, para [00113], lines 1-8; pg 47, para [00128], Table 6; pg 47, para [00130], lines 1-6).
As to claim 32, Lin teaches a method of treating PSMA expressing cancer comprising administering to a subject in need the PSMA binding ligand with a radionuclide (pg 34, para [0078], lines 1-7).
As to claim 33, Lin teaches a method for diagnosing PSMA expressing cancer using a diagnostic method comprising the PSMA binding ligand (pg 4, para [0017], lines 1-3; pg 33, para [0076], lines 1-10; pg 43, para [00112], lines 1-4; pg 43, para [00113], lines 1-8; pg 47, para [00128], Table 6; pg 47, para [00130], lines 1-6).
As to claim 34, Lin teaches the radionuclide is a β-emitter (pg 34, para [0077], line 3).
As to claim 35, Lin teaches the radionuclide is an α-emitter (pg 34, para [0077], line5).
As to claim 36, Lin teaches a pharmaceutical composition comprising the complex (pg 5, para [0022], lines 1-7; pg 34, para [0078], lines 1-3).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin as applied to claims 1-25 and 27-36 above, and further in view of Eder, M.; et al., WO 2020/165409 A1. The teachings of Lin as applied in the previous rejection are incorporated in this rejection.
As to claim 26, Lin teaches a PSMA binding ligand with the structure (reproduced below) wherein A is DOTA (pg 16, para [0057], lines 1-2 and line 6; pg 55, Figure 1), Q2 is cyclohexyl (pg 15, para [0053], Formula (II)) and q is 1 (pg 15, para [0053], Formula (II)) and R2, R3, and R4 are -CO2H groups and R1 is H, and n1 is 0-4. The claimed range of n1 is 1-25 overlaps the prior art range of 0-4. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
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Lin does not teach that Q1 is
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Eder, M.; et al. (hereafter referred to as Eder-409) is drawn to PSMA ligands with an amylase cleavable linker (title; abstract). Eder-409 teaches prostate cancer is the leading cancer in the US and European populations with at least 1-2 million men in the western hemisphere suffering from prostate cancer (pg 1, lines 11-13) and a variety of low molecular weight compounds are used as imaging agents to help detect prostate cancer (pg 1, lines 21-32). Eder-409 teaches PSMA is a transmembrane glycoprotein that has abundant and restricted expression on the surface of prostate cancer (pg 2, lines 3-5) and that selective targeting of cancer cells with radiopharmaceuticals for imaging or therapeutic purposes is challenging (pg 2, lines 26-31). Eder-409 teaches PSMA binding ligands which are useful and advantageous radiopharmaceuticals and which can be used as tracers, imaging agents, and treatment of PSMA-expressing cancers (pg 3, lines 23-27). Eder-409 teaches a general structure A-LAQ-Q (pg 3, lines 35-37), where Q is a PSMA binding motif, A is a chelator, and LAQ is a linker (pg 3, lines 32-35). Eder-409 teaches the PSMA binding motif, Q, linker and chelator can be as shown below in formula (II) (pg 4, lines 6-33; pg 5, lines 1-6) where A is a chelator, Z1 is a functional moiety attached to a carbonyl group of A (pg 4, lines 30-33) and linker1 and linker2 are independently selected from the group consisting of aryl, alkylaryl, arylalkyl, cycloalkyl, heterocycloalkyl, heteroaryl, heteroarylalkyl, and alkylheteroaryl (pg 5, lines 4-6).
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Regarding Q1, Eder-409 teaches Q1 is
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It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to substitute the alkylaryl of Lin with the alkylaryl as taught by Eder-409 because the substituted components and their functions were known in the art and a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have yielded the predictable outcome of an napthyl-type alkylaryl as Q1.
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the alkylaryl of Lin with the alkylaryl of Eder-409 because the prior art of Lin disclosed Q1 can have many different alkylaryl groups at that position (pg 55, Figure 1; claims 5-7) known to successfully target PSMA and have a chelator. Additional prior art of Eder-409 suggested the 5-methylnapthyl substituent at the same location to have similar ability to target PSMA with a chelator (pg 4, lines 6-8, formula (II); pg 10, lines 26-35) because of the overlap of the structures between them involves known chemistry.
The skilled artisan would have been motivated to substitute the alkylaryl of Lin with the 5-methylnapthyl of Eder-409 because Eder-409 states the 5-methylnapthyl group is preferred (pg 45, line 21). Therefore, it would have been prima facie obvious to combine the teachings of Lin with Eder-409.
Pertinent Art
The prior art of Eder, M.; et al., WO 2020/165420 A1 (as cited in the IDS filed on 11/08/2024) is deemed pertinent to the application.
Eder, M.; et al. (hereafter referred to as Eder-420) is drawn to PSMA ligands with improved tissue specficity (title; abstract). Eder-420 teaches compounds useful and advantageous as radiopharmaceuticals and which can be used in nuclear medicine as tracers, imaging agents, and treatment of various disease states of PSMA-expressing cancers (pg 3, lines 24-28). Eder-420 teaches formula (I), shown below (pg 3, lines 29-31), where R1 is H or -CH3, R2, R3 and R4 are independently -CO2H, -SO2H, -SO3H, -OSO3H, -PO2H, -PO3H and -OPO3H2, Q1 is alkylaryl, arylalkyl, aryl, alkylheteroaryl, heteroarylalkyl, or heteroaryl, Q2 is aryl, alkylaryl, arylalkyl, cycloalkyl, heterocycloalkyl, heteroaryl, heteroarylalkyl or alkylheteroaryl, A is a chelator selected from DOTA, NOTA, NODAGA, DOTAGA, TRAP, NOPO, DFO, DTPA, or CHX-DTPA; wherein X1, X2, Y1, Y2, Z1 and Z2, are independently amino acids, q is 0-3, n, m and p, are independently 0-9; where n1, n2, m1, m2, p1, p2, are independently 0-3, and wherein n1 + n2 > 0, m1+ m2 > 0 and p1+ p2 > 0, and wherein n + m + p > 0 (pg 3, lines 32-36; pg 4, lines 1-19).
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The examiner considers the similarity between the PSMA binding ligands to render this art pertinent to this application.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 18-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-35 of copending Application No. 18/866,055 in view of Lin, K-S.; et al., WO 2020/210909 A1 (as cited in the IDS filed on 11/08/2024) and Eder, M.; et al., WO 2020/165409 A1. The teachings of Lin and Eder-409 as applied in the previous rejections are incorporated in this rejection.
Instant claims are drawn to a PSMA binding ligand comprising a PSMA binding motif Q, a chelator residue, A, linked via a linker comprising at least one N-alkylated amino acid where the general structure of the PSMA binding ligand is A-LAQ-Q, where Q is the general PSMA binding motif structure, A is a chelator, and LAQ is an amino acid backbone with alkylaryl, arylalkyl, aryl, alkylheteroaryl, heteroarylalkyl and heteroaryl R groups or comprising the R group between the methylene and carbonyl along the amino acid backbone; and, where the chelator may have a radionuclide; where the PSMA binding ligand is in a pharmaceutical composition; and where the PSMA binding ligand may be complexed with a radionuclide which can be an alpha or a beta emitter; and a method for treating or diagnosing PSMA expressing cancer comprising administering the PSMA binding ligand or complex to a subject.
The conflicting claims of copending U.S. Application No. 18/866,055 (hereafter referred to as '055) are drawn to a PSMA binding ligand comprising a PSMA binding motif Q, a chelator residue, A, linked via a linker comprising at least one amino acid where the general structure of the PSMA binding ligand is A-LAQ-Q, where Q is the general PSMA binding motif structure, A is a chelator, and LAQ is an amino acid backbone with alkylaryl, arylalkyl, aryl, alkylheteroaryl, heteroarylalkyl and heteroaryl R groups or comprising the R group between the methylene and carbonyl along the amino acid backbone; and, where the chelator may have a radionuclide; where the PSMA binding ligand is in a pharmaceutical composition; and where the PSMA binding ligand may be complexed with a radionuclide which can be an alpha or a beta emitter; and a method for treating or diagnosing PSMA expressing cancer comprising administering the PSMA binding ligand or complex to a subject.
The conflicting claims of '055 do not teach N-alkylated amino acids.
The conflicting claims of ‘248 do not teach Q1 is
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Lin, K-S., et al. (hereafter referred to as Lin) is drawn to radiolabeled compounds for diagnosis or treatment of PSMA expressing cancer (title; abstract). Lin teaches PSMA is a transmembrane protein that catalyzes the hydrolysis of N-acetyl-aspartylglutamate to glutamate and N-aceetylaspartate (pg 1, para [0002], lines 1-2) and it is not expressed in most normal tissues but is overexpressed in prostate tumors and metastases (pg 1, para [0002], lines 2-4) and PSMA-targeting endoradiotherapeutic agents are well studied (pg 1, para [0003], lines 1-13). Lin teaches a compound according to general Formula I, shown below) wherein R1a, R1b, and R1c are independently -CO2H, and other options, R2 is a linear or branched cyclic or acyclic, and /or aromatic or non-aromatic C1-C20 alkylenyl or alkenylenyl, or a linear or branched , cyclic or acyclic, and/or aromatic or non-aromatic X2-X20 heteroalkylenyl or heteroalkenylenyl, R3 is -O-, -S-, -S(O)-, -NHC(O)-, -C(O)NH- or other group, R4 is a group which may have multiple aromatic rings; R5 and R6 are independently hydrogen or methyl; Xaa1 is an amino acid of formula -N(R8)R9C(O)-, wherein each R8 is independently hydrogen or methyl and wherein each R9 is independently a linear or branched, cyclic or acyclic, and/or aromatic or non-aromatic C1-C20 alkylenyl, alkenylenyl or alkynylenyl or a linear or branched, cyclic or acylci, and/or aromatic or non-aromatic X2-X20 heteroalkylenyl, heteroalkenylenyl or heteroalkynylenyl; and Rx is a radiolabeling group independently selected from a radiometal and chelator (pg 2, para [0006]; pg 3, para [0006]). Lin teaches PET/CT, SPECT/CT imaging and biodistribution (pg 43, para [00112], lines 1-4; pg 43, para [00113], lines 1-8; pg 44, para [00114], lines 1-15; pg 44, para [00115], lines 1-8).
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Regarding N-alkylated amino acids, Lin teaches at least one linker LAQ comprising at least one N-alkylated amino acid X1, where instant claim “X1” is equivalent to prior art “Xaa1” (pg 2, para [0006], Formula (1); pg 2, para [0006], lines 10-11).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the PSMA binding agent of the conflicting claims of ‘055 to include N-alkylation of amino acids as taught by Lin because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of N-alkylated amino acids in the linker.
A person of ordinary skill in the art would have had a reasonable expectation of success in N-alkylation of the amino acids in the linker because the conflicting claims of ‘055 disclosed amino acids with various substituents as R groups known to have hydrogens on the nitrogen of the backbone. Additional prior art of Lin suggested amino acids with similar R groups on the linker amino acids with either hydrogen or alkyl groups on the backbone nitrogens to have similar PSMA binding ligand properties because of the overlap of amino acid structure between them involves known chemistry.
The skilled artisan would have been motivated to make the N-alkylation modification because methylated amino acids are more stable than the unalkylated amino acids. Therefore, it would have been prima facie obvious to combine the teachings of the conflicting claims of ‘055 with Lin.
Regarding Q1, Lin does not teach Q1 is
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Eder, M.; et al. (hereafter referred to as Eder-409) is drawn to PSMA ligands with an amylase cleavable linker (title; abstract). Eder-409 teaches prostate cancer is the leading cancer in the US and European populations with at least 1-2 million men in the western hemisphere suffering from prostate cancer (pg 1, lines 11-13) and a variety of low molecular weight compounds are used as imaging agents to help detect prostate cancer (pg 1, lines 21-32). Eder-409 teaches PSMA is a transmembrane glycoprotein that has abundant and restricted expression on the surface of prostate cancer (pg 2, lines 3-5) and that selective targeting of cancer cells with radiopharmaceuticals for imaging or therapeutic purposes is challenging (pg 2, lines 26-31). Eder-409 teaches PSMA binding ligands which are useful and advantageous radiopharmaceuticals and which can be used as tracers, imaging agents, and treatment of PSMA-expressing cancers (pg 3, lines 23-27). Eder-409 teaches a general structure A-LAQ-Q (pg 3, lines 35-37), where Q is a PSMA binding motif, A is a chelator, and LAQ is a linker (pg 3, lines 32-35). Eder-409 teaches the PSMA binding motif, Q, linker and chelator can be as shown below in formula (II) (pg 4, lines 6-33; pg 5, lines 1-6) where A is a chelator, Z1 is a functional moiety attached to a carbonyl group of A (pg 4, lines 30-33) and linker1 and linker2 are independently selected from the group consisting of aryl, alkylaryl, arylalkyl, cycloalkyl, heterocycloalkyl, heteroaryl, heteroarylalkyl, and alkylheteroaryl (pg 5, lines 4-6).
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Regarding Q1, Eder-409 teaches Q1 is
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It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to substitute the alkylaryl of the conflicting claims of ‘055 and Lin with the alkylaryl as taught by Eder-409 because the substituted components and their functions were known in the art and a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have yielded the predictable outcome of an napthyl-type alkylaryl as Q1.
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the alkylaryl of Lin with the alkylaryl of Eder-409 because the prior art of Lin disclosed Q1 can have many different alkylaryl groups at that position (pg 55, Figure 1; claims 5-7) known to successfully target PSMA and have a chelator. Additional prior art of Eder-409 suggested the 5-methylnapthyl substituent at the same location to have similar ability to target PSMA with a chelator (pg 4, lines 6-8, formula (II); pg 10, lines 26-35) because of the overlap of the structures between them involves known chemistry.
The skilled artisan would have been motivated to substitute the alkylaryl of Lin with the 5-methylnapthyl of Eder-409 because Eder-409 states the 5-methylnapthyl group is preferred (pg 45, line 21). Therefore, it would have been prima facie obvious to combine the teachings of the conflicting claims of ‘055 and Lin with Eder-409.
This is a provisional nonstatutory double patenting rejection.
Claims 18-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/431,248 in view of Lin, K-S.; et al., WO 2020/210909 A1 (as cited in the IDS filed on 11/08/2024) and Eder, M.; et al., WO 2020/165409 A1. The teachings of Lin and Eder-409 as applied in the previous rejections are incorporated in this rejection.
Instant claims are drawn to a PSMA binding ligand comprising a PSMA binding motif Q, a chelator residue, A, linked via a linker comprising at least one N-alkylated amino acid where the general structure of the PSMA binding ligand is A-LAQ-Q, where Q is the general PSMA binding motif structure, A is a chelator, and LAQ is an amino acid backbone with alkylaryl, arylalkyl, aryl, alkylheteroaryl, heteroarylalkyl and heteroaryl R groups or comprising the R group between the methylene and carbonyl along the amino acid backbone; and, where the chelator may have a radionuclide; where the PSMA binding ligand is in a pharmaceutical composition; and where the PSMA binding ligand may be complexed with a radionuclide which can be an alpha or a beta emitter; and a method for treating or diagnosing PSMA expressing cancer comprising administering the PSMA binding ligand or complex to a subject.
The conflicting claims of copending U.S. Application No. 17/431,248 (hereafter referred to as '248) are drawn to a PSMA binding ligand comprising a PSMA binding motif Q, a chelator residue, A, linked via a linker comprising at least one amino acid where the general structure of the PSMA binding ligand is A-LAQ-Q; where Q is the general PSMA binding motif structure, A is a chelator, and LAQ is an amino acid backbone and a oligosaccharide.
The conflicting claims of '248 do not teach N-alkylated amino acids.
The conflicting claims of '248 do not teach the PSMA binding ligand is in a pharmaceutical composition.
The conflicting claims of '248 do not teach the PSMA binding ligand may be complexed with a radionuclide which can be an alpha or a beta emitter.
The conflicting claims of '248 do not teach a method for treating or diagnosing PSMA expressing cancer comprising administering the PSMA binding ligand or complex to a subject.
The conflicting claims of ‘248 do not teach Q1 is
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Lin, K-S., et al. (hereafter referred to as Lin) is drawn to radiolabeled compounds for diagnosis or treatment of PSMA expressing cancer (title; abstract). Lin teaches PSMA is a transmembrane protein that catalyzes the hydrolysis of N-acetyl-aspartylglutamate to glutamate and N-aceetylaspartate (pg 1, para [0002], lines 1-2) and it is not expressed in most normal tissues but is overexpressed in prostate tumors and metastases (pg 1, para [0002], lines 2-4) and PSMA-targeting endoradiotherapeutic agents are well studied (pg 1, para [0003], lines 1-13). Lin teaches a compound according to general Formula I, shown below) wherein R1a, R1b, and R1c are independently -CO2H, and other options, R2 is a linear or branched cyclic or acyclic, and /or aromatic or non-aromatic C1-C20 alkylenyl or alkenylenyl, or a linear or branched , cyclic or acyclic, and/or aromatic or non-aromatic X2-X20 heteroalkylenyl or heteroalkenylenyl, R3 is -O-, -S-, -S(O)-, -NHC(O)-, -C(O)NH- or other group, R4 is a group which may have multiple aromatic rings; R5 and R6 are independently hydrogen or methyl; Xaa1 is an amino acid of formula -N(R8)R9C(O)-, wherein each R8 is independently hydrogen or methyl and wherein each R9 is independently a linear or branched, cyclic or acyclic, and/or aromatic or non-aromatic C1-C20 alkylenyl, alkenylenyl or alkynylenyl or a linear or branched, cyclic or acylci, and/or aromatic or non-aromatic X2-X20 heteroalkylenyl, heteroalkenylenyl or heteroalkynylenyl; and Rx is a radiolabeling group independently selected from a radiometal and chelator (pg 2, para [0006]; pg 3, para [0006]). Lin teaches PET/CT, SPECT/CT imaging and biodistribution (pg 43, para [00112], lines 1-4; pg 43, para [00113], lines 1-8; pg 44, para [00114], lines 1-15; pg 44, para [00115], lines 1-8).
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Regarding N-alkylated amino acids, Lin teaches at least one linker LAQ comprising at least one N-alkylated amino acid X1, where instant claim “X1” is equivalent to prior art “Xaa1” (pg 2, para [0006], Formula (1); pg 2, para [0006], lines 10-11).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the PSMA binding agent of the conflicting claims of ‘248 to include N-alkylation of amino acids as taught by Lin because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of N-alkylated amino acids in the linker.
A person of ordinary skill in the art would have had a reasonable expectation of success in N-alkylation of the amino acids in the linker because the conflicting claims of ‘248 disclosed amino acids with various substituents as R groups known to have hydrogens on the nitrogen of the backbone. Additional prior art of Lin suggested amino acids with similar R groups on the linker amino acids with either hydrogen or alkyl groups on the backbone nitrogens to have similar PSMA binding ligand properties because of the overlap of amino acid structure between them involves known chemistry.
The skilled artisan would have been motivated to make the N-alkylation modification because methylated amino acids are more stable than the unalkylated amino acids. Therefore, it would have been prima facie obvious to combine the teachings of the conflicting claims of ‘248 with Lin.
Regarding the PSMA binding ligand is in a pharmaceutical composition, Lin teaches a pharmaceutical composition comprising the PSMA binding ligand (pg 5, para [0022], lines 1-7; pg 34, para [0078], lines 1-3).
Regarding the PSMA binding ligand may be complexed with a radionuclide which can be an alpha or a beta emitter, Lin teaches the radionuclide is a β-emitter (pg 34, para [0077], line 3) and Lin teaches the radionuclide is an α-emitter (pg 34, para [0077], line5).
Regarding a method for treating or diagnosing PSMA expressing cancer comprising administering the PSMA binding ligand or complex to a subject, Lin teaches a method of treating PSMA expressing cancer comprising administering to a subject in need the PSMA binding ligand with a radionuclide (pg 34, para [0078], lines 1-7) and Lin teaches a method for diagnosing PSMA expressing cancer using a diagnostic method comprising the PSMA binding ligand (pg 4, para [0017], lines 1-3; pg 33, para [0076], lines 1-10; pg 43, para [00112], lines 1-4; pg 43, para [00113], lines 1-8; pg 47, para [00128], Table 6; pg 47, para [00130], lines 1-6).
Regarding Q1, Lin does not teach Q1 is
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Eder, M.; et al. (hereafter referred to as Eder-409) is drawn to PSMA ligands with an amylase cleavable linker (title; abstract). Eder-409 teaches prostate cancer is the leading cancer in the US and European populations with at least 1-2 million men in the western hemisphere suffering from prostate cancer (pg 1, lines 11-13) and a variety of low molecular weight compounds are used as imaging agents to help detect prostate cancer (pg 1, lines 21-32). Eder-409 teaches PSMA is a transmembrane glycoprotein that has abundant and restricted expression on the surface of prostate cancer (pg 2, lines 3-5) and that selective targeting of cancer cells with radiopharmaceuticals for imaging or therapeutic purposes is challenging (pg 2, lines 26-31). Eder-409 teaches PSMA binding ligands which are useful and advantageous radiopharmaceuticals and which can be used as tracers, imaging agents, and treatment of PSMA-expressing cancers (pg 3, lines 23-27). Eder-409 teaches a general structure A-LAQ-Q (pg 3, lines 35-37), where Q is a PSMA binding motif, A is a chelator, and LAQ is a linker (pg 3, lines 32-35). Eder-409 teaches the PSMA binding motif, Q, linker and chelator can be as shown below in formula (II) (pg 4, lines 6-33; pg 5, lines 1-6) where A is a chelator, Z1 is a functional moiety attached to a carbonyl group of A (pg 4, lines 30-33) and linker1 and linker2 are independently selected from the group consisting of aryl, alkylaryl, arylalkyl, cycloalkyl, heterocycloalkyl, heteroaryl, heteroarylalkyl, and alkylheteroaryl (pg 5, lines 4-6).
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Regarding Q1, Eder-409 teaches Q1 is
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It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to substitute the alkylaryl of the conflicting claims of ‘248 and Lin with the alkylaryl as taught by Eder-409 because the substituted components and their functions were known in the art and a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have yielded the predictable outcome of an napthyl-type alkylaryl as Q1.
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the alkylaryl of Lin with the alkylaryl of Eder-409 because the prior art of Lin disclosed Q1 can have many different alkylaryl groups at that position (pg 55, Figure 1; claims 5-7) known to successfully target PSMA and have a chelator. Additional prior art of Eder-409 suggested the 5-methylnapthyl substituent at the same location to have similar ability to target PSMA with a chelator (pg 4, lines 6-8, formula (II); pg 10, lines 26-35) because of the overlap of the structures between them involves known chemistry.
The skilled artisan would have been motivated to substitute the alkylaryl of Lin with the 5-methylnapthyl of Eder-409 because Eder-409 states the 5-methylnapthyl group is preferred (pg 45, line 21). Therefore, it would have been prima facie obvious to combine the teachings of the conflicting claims of ‘248 and Lin with Eder-409.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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