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 .
Information Disclosure Statement
The information disclosure statements filed April 19, 2024, May 9, 2024, and June 26, 2024 are acknowledged and have been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The abstract of the disclosure is objected to because it is too short (21 words). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 33 is objected to because of the following informalities: the phrase "claims 15" in line 3 of the claim is in plural form when referring to a singular claim. Appropriate correction is required.
Claim Interpretation
Claim 2 contains several structural options for the Y moieties of the compound of claim 2. The examiner interprets these options to contain lists of structure options within lists. The examiner interprets the scope of claim 2 to be that at least one of paragraph a), paragraph b), or paragraph c) must be true of a molecule to be within the scope of claim 2. Furthermore, the examiner interprets paragraph c) to further contain another list of lists. In this instance, the examiner interprets the scope of paragraph c) of claim 2 to be that at least one of the three following sets of statements must be true in order for the limitation of paragraph c) to be true:
(i) Y1 and Y2 are each, independently, alkyl-CO2H, alkylaryl-CO2H, alkylheteroaryl-CO2H, alkylheteroaryl-(NO2)CO2H, alkyl-P(O)(OH)2, alkylaryl-P(O)(OH)2, alkylheteroaryl-P(O)(OH)2, or alkylheteroaryl-(NO2)P(O)(OH)2;
(ii) Y3 is Z1-L(A) or Z1-L(A)(B) and Y4 is -H; or
(iii) Y4 is Z1-L(A) or Z1-L(A)(B) and Y3 is -H.
Therefore, if any of (i), (ii), or (iii) as defined above is true for a compound, it is understood by the examiner to read on paragraph c) and thus claim 2.
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 6 and 32 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.
Regarding claim 6, in paragraph c), the claim recites that moiety A may be “((5-(2-(4-(aminomethyl) cyclohexane-1-carboxamido)-3-(naphthalen-2-yl) propanamido)-1-carboxypentyl) carbamoyl) glutamic acid or a derivative or fragment thereof,” or “2-[3-(1,3-dicarboxypropyl) ureido] pentanedioic acid (DUPA) or a derivative or fragment thereof,” or “trastuzumab, bombesin or somatostatin or a derivative or fragment thereof.” The term “derivative” renders each of these options unclear in scope. It is not clear to what extent of modification these compounds may be modified while still being considered a derivative. Thus, this language makes it unclear what the scope of the claimed structures are, rendering the claim indefinite.
Regarding claim 32, the 14th structure provided in claim 32 (the third on pg. 22 of the pending claim set) contains a moiety designated as “R.” However, in none of the preceding claims upon which claim 32 directly or indirectly depends is a definition for a group “R.” Therefore, the scope of what the structure of the “R” moiety may be is indefinite, making the full structure indefinite, thus rendering the claim as a whole indefinite.
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 4, 17, 20, and 32 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.
Regarding claim 4, the 17th and 18th structures of the claim (the 8th and 9th structures on pg. 5 of the pending claim set) contain methyl phosphinate groups in the Y2 and Y3 positions. However, methyl phosphinate groups (P(O)OH(CH3)) are not within the scope of claim 1, upon which claim 4 depends. Claim 1 allows for phosphonate (P(O)(OH)2) groups, but not phosphinate groups. Therefore, claim 4 is understood to fail to include all the limitations of the claim upon which it depends and is thus rejected.
Regarding claim 17, claim 17 depends upon claim 16 and thus requires the compound to contain a chemical linker and targeting moiety, as these are required in all embodiments of claim 16. However, the last six structures of instant claim 17 do not contain chemical linkers or targeting moieties. Therefore, claim 17 fails to include all the limitations of the claim upon which it depends and is thus rejected.
Regarding claim 20, none of the structures claimed contain a coordinated metal group, as is required in claim 17, upon which claim 20 depends. Therefore, claim 20 is understood to fail to include all the limitations of the claim upon which it depends and is thus rejected.
Regarding claim 20, claim 20 depends directly upon claim 17, which depends upon claim 16, which depends upon claim 15, which depends upon claim 15. All of the structures of claim 20 contain Y1 and Y2 moieties in their generic form. The Y1 and Y2 moieties of claim 17 are specific options within the scope of Y1 and Y2 moieties as defined in claim 1 (no further narrowing definition is provided in either claim 15 or 16). However, as the Y1 and Y2 moieties of claim 20 are generic, the scope of these structures as claimed is understood to include all possible Y1 and Y2 structures as defined in claim 1. The Y1 and Y2 moiety definitions in claim 1 include structures that are not included in the embodiments of claim 17 (e.g., -H). Thus, not all of the structures within the scope of claim 20 would be within the scope of claim 17. Therefore, claim 20 is understood to fail to include all the limitations of the claim upon which it depends and is thus rejected.
Regarding claim 32, the claim depends directly upon claim 15 and thus indirectly upon claim 1. Claim 1 requires a compound having a certain structure and provides a generic form of the structure. Claim 1 also requires that the specific embodiments of the generic formula are not one of five provided structures. In this case, first provided structure in claim 32 and the 9th (second on pg. 21 of the pending claim set) are metal coordinated structures having the same structure as the first structure provided in the list of excluded structures in claim 1. Therefore, claim 32 is understood to fail to include all the limitations of the claim upon which it depends and is thus rejected.
Regarding claim 32, the claim depends directly upon claim 15 and thus indirectly upon claim 1. Claim 1 requires a compound having a certain structure and provides a generic form of the structure. Based on this generic structure, all compounds of claim 1 must contain a TACN (1,4,7-triazacyclononane) core component to the chelator portion of the molecule. However, the last four claimed structures in claim 32 contain cyclen-based chelators and do not contain TACN groups. Therefore, claim 32 is understood to fail to include all the limitations of the claim upon which it depends and is thus rejected.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims 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.
(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, 12, 13, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuppers (Kuppers, H. J.; et al., Inorg. Chem., 1986).
Kuppers discloses the compound TACN (1,4,7-triazacyclononane) (pg. 2401, left column, structures). Kuppers teaches forming complexes of TACN with cobalt (pg. 2401, right column, first full paragraph).
Regarding claim 1, the TACN compound of Kuppers (pg. 2401) reads on the compound of claim 1 wherein each of Y1, Y2, Y3, and Y4 is -H.
Regarding claim 12, the TACN compound of Kuppers (pg. 2401) reads on the compound of claim 12 wherein each of Y1 and Y2 is -H.
Regarding claim 13, the TACN compound of Kuppers (pg. 2401) reads on the compound of claim 13 wherein each of Y1 and Y2 is -H (option a)).
Regarding claim 21, the TACN compound of Kuppers (pg. 2401) reads on the compound of claim 21 wherein each of Y1 and Y2 is -H (option b)).
Claims 1, 2, 12, 13, 15, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaughn (Vaughn, B. A.; et al., Chem. Sci., 2020).
Vaughn discloses the compounds H3mpatcn, H3bpatcn, and H3tpatcn, which are triaza-macrocycles modified with acetate and picolinate groups (pg. 334, Fig. 1). Vaughn teaches the radiolabeling of mpatcn with 44Sc (pg. 335, Radiolabeling with 44Sc; and pg. 336, Fig. 2).
Regarding claim 1, the H3mpatcn compound of Vaughn (Fig. 1) reads on the compound of claim 1 wherein Y4 is -H, Y1 and Y2 are alkyl-CO2H, and Y3 is a picolinate group (the 6th option provided in the list of options for Y3 and Y4 in claim 1). The examiner notes that when Y4 is -H, the core ring of the compound of claim 1 is symmetric and thus the assignment of nitrogen-modifying groups as Y1, Y2, and Y3 is arbitrary in some instances, as the molecule can be rotated about the center axis.
Regarding claim 2, the H3mpatcn compound of Vaughn (Fig. 1) reads on the compound of claim 2 wherein Y1 and Y2 are alkyl-CO2H (one of the options within paragraph c)).
Regarding claim 12, the H3mpatcn compound of Vaughn (Fig. 1) reads on the compound of claim 12 wherein Y1 and Y2 are alkyl-CO2H.
Regarding claim 13, the H3mpatcn compound of Vaughn (Fig. 1) reads on the compound of claim 13 wherein Y1 and Y2 are alkyl-CO2H (option b)).
Regarding claim 15, Vaughn teaches the radiolabeling of mpatcn with 44Sc (pg. 335, Radiolabeling with 44Sc; and pg. 336, Fig. 2).
Regarding claim 21, the H3mpatcn compound of Vaughn (Fig. 1) reads on the compound of claim 21 wherein Y1 and Y2 are -CH2-CO2H (paragraph b, second option)).
Claims 1-3, 6, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidtke (Schmidtke, A.; et al., Inorg. Chem., 2017).
Schmidtke teaches the preparation of NODIA-Me-PSMA (pg. 9101, Scheme 3; and pg. 9099, NODIA-Me-PSMA). Schmidtke also teaches the radiolabeling of NODIA-Me-PSMA with 68Ga (pg. 9099-9100, 68Ga NODIA-MePSMA). Schmidtke further teaches performing targeted imaging using NODIA-Me-PSMA in mice (pg. 9106, Figure 5).
Regarding claim 1, the NODIA-Me-PSMA compound of Schmidtke (Scheme 3) reads on the compound of claim 1 wherein Y4 is -H, Y1 and Y2 are alkyl-heteroaryl, and Y3 is L(A) wherein L is an amide linker and A is a PSMA targeting moiety. The examiner notes that when Y4 is -H, the core ring of the compound of claim 1 is symmetric and thus the assignment of nitrogen-modifying groups as Y1, Y2, and Y3 is arbitrary in some instances, as the molecule can be rotated about the center axis.
Regarding claim 2, the NODIA-Me-PSMA compound of Schmidtke (Scheme 3) reads on the compound of claim 2 wherein Y4 is -H and Y3 is L(A) wherein L is an amide linker and A is a PSMA targeting moiety (which reads on options within both paragraphs a) and c)).
Regarding claim 3, the NODIA-Me-PSMA compound of Schmidtke (Scheme 3) reads on the compounds of claim 3 wherein Y4 is -H and Y3 is L(A), which is the second provided structure option.
Regarding claim 6, the NODIA-Me-PSMA compound of Schmidtke (Scheme 3) reads on the compounds of claim 6 wherein the targeting moiety A is a moiety with specificity for a target antigen on the surface of a cell. Schmidtke states that the NODIA-Me group is conjugates to a prostate-specific membrane antigen targeting moiety (pg. 9097, Abstract).
Regarding claim 21, the NODIA-Me-PSMA compound of Schmidtke (Scheme 3) reads on the compounds of claim 21 wherein the chemical linker is alkyl-C(O)NH-alkyl.
Claims 1-4, 6, 12, 13, 15, 16, 21, and 33-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Umbricht (Umbricht, C. A.; et al., Mol. Pharmaceutics, 2018).
Umbricht teaches a compound PSMA-ALB-89 (pg. 5557, Figure 1). Umbricht describes this molecule as a modified form of PSMA-ALB-56 wherein DOTA is exchanged for the NODAGA chelator (pg. 5556, Abstract). Umbricht also teaches radiolabeling PSMA-ALB-89 with 64Cu (pg. 5558, Radiolabeling and Stability). Umbricht further teaches performing PET/CT imaging on mice injected with the radiolabeled compound (pg. 5559, PET/CT Imaging Studies; and pg. 5561, Figure 4). Umbricht describes the molecule as an albumin-binding PSMA-targeting agent (pg. 5558, left column, first full paragraph).
Regarding claim 1, the PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 1 wherein Y4 is -H; Y1 and Y2 are alkyl-CO2H; and Y3 is Z1-L(A)(B) wherein Z1 is the first provided structure in its corresponding definition in claim 1 and the Y5 moiety within it is -CO2H, L is a chemical linker group, A is a PSMA targeting ligand, and B is an albumin-binding moiety.
Regarding claim 2, the PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 2 wherein Y1 and Y2 are alkyl-CO2H. This compound also reads on the compound of claim 2 wherein Y3 is Z1-L(A)(B) and Y4 is -H.
Regarding claim 3, the PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 3 wherein it has the structure provided as the third option in the recited list.
Regarding claim 4, the PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 4 wherein it has the structure provided as the fifth option in the recited list.
Regarding claim 6, the PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 6 wherein targeting moiety A is a moiety with specificity for a target protein on the surface of a cell (prostate specific membrane antigen).
Regarding claim 12, the PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 12 wherein each of Y1 and Y2 are alkyl-CO2H.
Regarding claim 13, the PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 13 wherein each of Y1 and Y2 are alkyl-CO2H (option b)).
Regarding claim 15, the PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 1 as described above. Furthermore, Umbricht teaches forming a complex of PSMA-ALB-89 with 64Cu (pg. 5558, Radiolabeling and Stability).
Regarding claim 16, the 64Cu-radiolabeled PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 16 wherein it has the structure provided as the fifth option in the recited list.
Regarding claim 21, the PSMA-ALB-89 compound of Umbricht (Figure 1) reads on the compound of claim 21 wherein Y1 and Y2 are each –CH2-CO2H (the second option recited in paragraph b)). PSMA-ALB-89 also reads on the compound of claim 21 wherein Z1 is the first provided option in paragraph c). furthermore, PSMA-ALB-89 reads on the compound of claim 21 having the structure as defined on pg. 15 of the currently pending claim set wherein Z1 is the first option, Y1 and Y2 are each –CH2-CO2H (the second option in this respective list), B has the recited structure wherein X is a methyl (alkyl) group.
Regarding claim 33, Umbricht teaches performing PET/CT experiments by first injecting mice with the 64Cu-radiolabeled PSMA-ALB-89 compound diluted in saline (pg. 5559, PET/CT Imaging Studies). The examiner interprets saline to be a pharmaceutically acceptable carrier. In this instance, the preparation was to be intravenously injected into a mouse for nuclear imaging studies, which is a pharmaceutical use. Therefore, the material injected into the mice is understood to be a pharmaceutical composition comprising a metal complex that reads on claim 15 (see above) and a pharmaceutically acceptable carrier.
Regarding claim 34, Umbricht teaches performing PET/CT experiments using the 64Cu-radiolabeled PSMA-ALB-89 compound that reads on claim 15 (see above) in mice (pg. 5559, PET/CT Imaging Studies). Umbricht states that the imaging was performed using a small-animal PET/CT scanner, which the examiner interprets to be a molecular imaging device. Umbricht provides images of the result of this method (pg. 5561, Figure 4), which the examiner interprets to be evidence of detection of the metal complex in the subject. Additionally, these tumors are made of PSMA-expressing PC3-PIP cells (pg. 5558, Cell Uptake and Internalization; and In Vivo Studies). Thus, the imaging of the PSMA-expressing tumor is considered by the examiner to be the detection of target cells.
Regarding claim 35, Umbricht teaches performing PET/CT experiments using the 64Cu-radiolabeled PSMA-ALB-89 compound that reads on claim 15 (see above) in mice (pg. 5559, PET/CT Imaging Studies). Umbricht provides images of the result of this method (pg. 5561, Figure 4), which the examiner interprets to be evidence of detection of the metal complex in the subject. Therefore, the method of Umbricht is understood to include administering a compound that reads on claim 15, detecting the location of the metal complex in the subject, and obtaining an image based on the location of the metal complex in the subject. Umbricht teaches that PSMA-ALB-89 displayed high tumor uptake in the experiment (pg. 5561, left column), indicating the at the radiolabeled compound specifically accumulated at target cells expressing PSMA. Additionally, these tumors are made of PSMA-expressing PC3-PIP cells (pg. 5558, Cell Uptake and Internalization; and In Vivo Studies). Thus, the imaging of the PSMA-expressing tumor is considered by the examiner to be obtaining an image of target cells.
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.
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, 14-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Umbricht (Umbricht, C. A.; et al., Mol. Pharmaceutics, 2018) in view of Vaughn (Vaughn, B. A.; et al., Chem. Sci., 2020).
As described above, Umbricht teaches a compound PSMA-ALB-89 (pg. 5557, Figure 1). Umbricht describes this molecule as a modified form of PSMA-ALB-56 wherein DOTA is exchanged for the NODAGA chelator (pg. 5556, Abstract). Umbricht also teaches radiolabeling PSMA-ALB-89 with 64Cu (pg. 5558, Radiolabeling and Stability). Umbricht further teaches performing PET/CT imaging on mice injected with the radiolabeled compound (pg. 5559, PET/CT Imaging Studies; and pg. 5561, Figure 4). Umbricht describes the molecule as an albumin-binding PSMA-targeting agent (pg. 5558, left column, first full paragraph).
Umbricht does not teach a conjugate of a TACN derivative chelator, an albumin binding moiety, and a PSMA-targeting moiety wherein the chelating moiety arms off the nitrogens of the TACN ring are structures other than -alkyl-CO2H.
As described above, Vaughn discloses the compounds H3mpatcn, H3bpatcn, and H3tpatcn, which are triaza-macrocycles modified with acetate and picolinate groups (pg. 334, Fig. 1). Vaughn teaches the radiolabeling of mpatcn with 44Sc (pg. 335, Radiolabeling with 44Sc; and pg. 336, Fig. 2). Vaughn further teaches the conjugation of an H3mpatcn derivative (picaga) to DUPA (pg. 338, Scheme 1) and radiolabeling this conjugate to prepare Sc(picaga)-DUPA (Fig. 5; and pg. 335, right column). Vaughn compares the performance of picaga-DUPA to DOTA-DUPA (Fig. 5) in radiolabeling properties and finds that 44Sc radiolabeling at room temperature is improved for picaga-DUPA compared to the DOTA-derivative analog (Fig. 6). Vaughn further teaches using 44Sc(picaga)-DUPA for PET-CT in mice (Fig. 7).
A person of ordinary skill in the art would recognize that both Umbricht and Vaughn teach PSMA-targeting chelator conjugates. It would also be recognized that Umbricht and Vaughn teach the NODAGA and picaga chelating groups as substitution chelating groups for DOTA for the purpose of chelating radionuclides. It would thus be understood that NODAGA and picaga therefore can be substitutes of each other.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the PSMA-ALB-89 compound of Umbricht by substituting in the picaga chelating group of Vaughn in place of the NODAGA group in PSMA-ALB-89 because these are both known chelating groups that serve similar purposes and can be predictably interchanged (MPEP § 2143(I)(B)). This combination would yield the predictable result of a picaga chelator conjugated to an albumin binding moiety and PSMA-targeting moiety as depicted in the following structure.
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A person of ordinary skill in the art would have had a reasonable expectation of success in making this modification because both Umbricht and Vaughn teach NODAGA and picaga as radiometal chelating groups that can be substituted in place of DOTA. This would transitively suggest these chelators could be reasonable substitutes for each other. Furthermore, Vaughn teaches that the modification of mpatcn to picaga was done by introducing a functionalized glutarate group “in close analogy to the 6-coordinate NODAGA” (pg. 338, Functionalization of mpatcn:picaga), indicating high structural similarity between NODAGA and picaga, especially in the glutarate group used to connect to a linker or binding/targeting group.
The skilled artisan would have been motivated to make this modification because it would provide an alternative chelator conjugate to use. Furthermore, as Vaughn teaches the picaga conjugate bound better to 44Sc than did a DOTA derivative conjugate, suitability for use in 44Sc-containing PSMA-targeting conjugates would encourage the skilled artisan to incorporate the picaga chelator in place of NODAGA in PSMA-ALB-89.
Regarding claim 1, the structure of Formula (A) reads on the compound of claim 1 wherein Y4 is -H; Y1 is alkyl-CO2H; Y2 is alkylheteroaryl-CO2H; and Y3 is Z1-L(A)(B) wherein Z1 is the first provided structure in its corresponding definition in claim 1 and the Y5 moiety within it is -CO2H, L is a chemical linker group, A is a PSMA targeting ligand, and B is an albumin-binding moiety. Therefore, the combined teachings of Umbricht and Vaughn render claim 1 obvious.
Regarding claim 14, the structure of Formula (A) reads on the 7th recited structure provided in the list in this claim wherein A is a PSMA-targeting moiety and B is an albumin binding moiety and the glutarate group of picaga is the linker. Therefore, the combined teachings of Umbricht and Vaughn render claim 14 obvious.
Regarding claim 15, Umbricht teaches complexing teaches radiolabeling PSMA-ALB-89 with 64Cu (pg. 5558, Radiolabeling and Stability). Furthermore, Vaughn teaches radiolabeling picaga-DUPA with 44Sc (Fig. 5; and pg. 335, right column). The coordination of either of these radionuclides in the structure of Formula (A) would read on claim 15. Therefore, the combined teachings of Umbricht and Vaughn render claim 15 obvious.
Regarding claim 16, the structure of Formula (A) bound to either 64Cu or 44Sc reads on the compound of claim 16 having the 5th recited structure provided in the list in this claim (the first of the second row) wherein Y1 is alkyl-CO2H; Y2 is alkylheteroaryl-CO2H; and Z1 is the first provided structure in its corresponding definition in claim 1 and the Y5 moiety within it is -CO2H, L is a chemical linker group (glutarate side chain of picaga), A is a PSMA targeting ligand, and B is an albumin-binding moiety. Therefore, the combined teachings of Umbricht and Vaughn render claim 16 obvious.
Regarding claim 17, the structure of Formula (A) bound to either 64Cu or 44Sc reads on the compound of claim 17 having the 7th recited structure provided in the list in this claim (the first on pg. 11) wherein A is a PSMA-targeting moiety and B is an albumin binding moiety and the glutarate group of picaga is the linker. Therefore, the combined teachings of Umbricht and Vaughn render claim 17 obvious.
Regarding claim 20, the structure of Formula (A) bound to either 64Cu or 44Sc reads on the compound of claim 20 having the 3rd recited structure provided in the list in this claim wherein Y1 is alkyl-CO2H; Y2 is alkylheteroaryl-CO2H; and Z1 is the first provided structure in its corresponding definition in claim 1 and the Y5 moiety within it is -CO2H, L is a chemical linker group (glutarate side chain of picaga), and B is an albumin-binding moiety. Therefore, the combined teachings of Umbricht and Vaughn render claim 20 obvious.
Claims 1, 21, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Umbricht (Umbricht, C. A.; et al., Mol. Pharmaceutics, 2018) in view of Benesova (WO 2018/215627 A1).
As described above, Umbricht teaches a compound PSMA-ALB-89 (pg. 5557, Figure 1). Umbricht describes this molecule as a modified form of PSMA-ALB-56 wherein DOTA is exchanged for the NODAGA chelator (pg. 5556, Abstract). Umbricht also teaches radiolabeling PSMA-ALB-89 with 64Cu (pg. 5558, Radiolabeling and Stability). Umbricht further teaches performing PET/CT imaging on mice injected with the radiolabeled compound (pg. 5559, PET/CT Imaging Studies; and pg. 5561, Figure 4). Umbricht describes the molecule as an albumin-binding PSMA-targeting agent (pg. 5558, left column, first full paragraph).
Umbricht does not teach a conjugate of a TACN derivative chelator, an albumin binding moiety, and a PSMA-targeting moiety wherein the albumin binding moiety contains a para-iodo modification of the phenyl group.
Benesova teaches compound and radiolabeled complexes comprising a chelating agent, a PSMA-binding moiety, and an albumin-binding moiety connected by suitable linkers (pg. 1, first paragraph). Benesova states that the albumin-binding moiety preferably has one of the following structures (pg. 22):
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Specific embodiments of Benesova are (7a)(i), (7a)(ii), and (7a)(iii) (pg. 49-50). Notably, structure (7a)(ii) contains a para-iodo-modified phenyl group in the albumin-binding group and is otherwise identical to the para-methylphenyl-containing (7a)(i). Benesova also discloses embodiments with a linker between the chelating group and the albumin binding group, the (7b) structures (pg. 52-54).
A person of ordinary skill in the art would recognize that both Umbricht and Benesova teach PSMA-targeting chelator conjugates further containing albumin-binding groups. It would also be recognized that Benesova describes that both methyl- and iodo-modified phenyl groups are suitable for this function, indicating that these groups can be used as substitutes for each other.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the PSMA-ALB-89 compound of Umbricht by substituting the methyl of the phenyl group in the albumin-binding moiety with the iodo group as taught by Benesova because Benesova indicates that both of these modifications are suitable for the same use and can be predictably interchanged (MPEP § 2143(I)(B)). This combination would yield the predictable result of the following structure.
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A person of ordinary skill in the art would have had a reasonable expectation of success in making this modification because Benesova teaches that either the methyl- or iodo-modified phenyl group are suitable for this purpose and teaches related structures containing either group.
The skilled artisan would have been motivated to make this modification because it would provide an alternative albumin binding group structure to consider when developing the conjugate as a radiopharmaceutical that might result in better pharmacokinetic and pharmacodynamic properties.
Regarding claim 1, the structure of Formula (B) reads on the compound of claim 1 wherein Y4 is -H; Y1 and Y2 are both alkyl-CO2H; and Y3 is Z1-L(A)(B) wherein Z1 is the first provided structure in its corresponding definition in claim 1 and the Y5 moiety within it is -CO2H, L is a chemical linker group, A is a PSMA targeting ligand, and B is an albumin-binding moiety. Therefore, the combined teachings of Umbricht and Benesova render claim 1 obvious.
Regarding claim 21, the structure of Formula (B) reads on the compound of claim 21 wherein Y1 and Y2 are each –CH2-CO2H (the second option recited in paragraph b)). Formula (B) also reads on the compound of claim 21 wherein Z1 is the first provided option in paragraph c). Furthermore, Formula (B) reads on the compound of claim 21 having the structure as defined on pg. 15 of the currently pending claim set wherein Z1 is the first option, Y1 and Y2 are each –CH2-CO2H (the second option in this respective list), B has the recited structure wherein X is iodine (a halogen). Therefore, the combined teachings of Umbricht and Benesova render claim 21 obvious.
Regarding claim 27, the structure of Formula (B) reads on the compound of claim 27 wherein Y1 and Y2 are each –CH2-CO2H (the second option in this respective list) and Y5 is -CO2H. Therefore, the combined teachings of Umbricht and Benesova render claim 27 obvious.
Claims 21, 27, 30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Umbricht and Vaughn, as applied to claims 1, 14-17, and 20 above, further in view of Benesova.
As described above, the combination of the teachings of Umbricht and Benesova results in a compound of Formula (A). Additionally, Umbricht teaches radiolabeling PSMA-ALB-89 with 64Cu (pg. 5558, Radiolabeling and Stability) and performing PET/CT imaging on mice (pg. 5559, PET/CT Imaging Studies; and pg. 5561, Figure 4). Furthermore, Vaughn teaches that a picaga chelator conjugate is radiolabeled with 44Sc more efficiently than a related conjugate comprising a DOTA-derivative chelator (Fig. 6). Vaughn further teaches using 44Sc(picaga)-DUPA for PET-CT in mice (Fig. 7).
The combination of the teachings of Umbricht and Vaughn (Formula (A)) does not teach a conjugate of a TACN derivative chelator, an albumin binding moiety, and a PSMA-targeting moiety wherein the albumin binding moiety contains a para-iodo modification of the phenyl group.
As described above, Benesova teaches compound and radiolabeled complexes comprising a chelating agent, a PSMA-binding moiety, and an albumin-binding moiety connected by suitable linkers (pg. 1, first paragraph). Benesova states that the albumin-binding moiety preferably has one of the following structures (pg. 22):
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Specific embodiments of Benesova are (7a)(i), (7a)(ii), and (7a)(iii) (pg. 49-50). Notably, structure (7a)(ii) contains a para-iodo-modified phenyl group in the albumin-binding group and is otherwise identical to the para-methylphenyl-containing (7a)(i). Benesova also discloses embodiments with a linker between the chelating group and the albumin binding group, the (7b) structures (pg. 52-54).
A person of ordinary skill in the art would recognize that Umbricht, Vaughn, and Benesova all teach PSMA-targeting chelator conjugates. It would also be recognized that both Umbricht and Benesova teach conjugates further containing albumin-binding groups. It would further be recognized that Benesova describes that both methyl- and iodo-modified phenyl groups are suitable for this function, indicating that these groups can be used as substitutes for each other.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the structure of Formula (A) taught by the combination of Umbricht and Vaughn by substituting the methyl of the phenyl group in the albumin-binding moiety with the iodo group as taught by Benesova because Benesova indicates that both of these modifications are suitable for the same use and can be predictably interchanged (MPEP § 2143(I)(B)). This combination would yield the predictable result of the following structure.
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A person of ordinary skill in the art would have had a reasonable expectation of success in making this modification because Benesova teaches that either the methyl- or iodo-modified phenyl group are suitable for this purpose and teaches related structures containing either group.
The skilled artisan would have been motivated to make this modification because it would provide an alternative albumin binding group structure to consider when developing the conjugate as a radiopharmaceutical that might result in better pharmacokinetic and pharmacodynamic properties.
Regarding claim 21, the structure of Formula (C) reads on the compound of claim 1 in the same ways that the compound of Formula (A) does as described above because the iodine substitution in the albumin binding moiety does not alter how each of the other groups are defined. Furthermore, the structure of Formula (C) more specifically reads on claim 21 wherein Y1 is –CH2-CO2H (the second option recited in paragraph b)) and Y2 is the 4th option in paragraph b) (the first option in the second line of paragraph b)). Formula (C) also reads on the compound of claim 21 wherein Z1 is the first provided option in paragraph c). Furthermore, Formula (C) reads on the compound of claim 21 having the structure as defined on pg. 15 of the currently pending claim set wherein Z1 is the first option, Y1 is –CH2-CO2H (the second option recited in this list) and Y2 is the 4th option in this list, and B contains the recited structure wherein X is iodine (a halogen). Therefore, the combined teachings of Umbricht, Vaughn, and Benesova render claim 21 obvious.
Regarding claim 27, the structure of Formula (C) reads on the compound of claim 27 wherein Y1 is –CH2-CO2H (the second option recited in this list) and Y2 is the 4th option in this list and Y5 is -CO2H. Therefore, the combined teachings of Umbricht, Vaughn, and Benesova render claim 27 obvious.
Regarding claim 30, the structure of Formula (C) is identical to the first recited structure in the list of options of this claim. Therefore, the combined teachings of Umbricht, Vaughn, and Benesova render claim 30 obvious.
Regarding claim 32, the structure of Formula (C) reads on the compound of claim 15 in the same ways that the compound of Formula (A) does as described above because the iodine substitution in the albumin binding moiety does not alter how each of the other groups are defined. Furthermore, the structure of Formula (C) more specifically reads on claim 32 because the complex of Formula (C) with either 64Cu or 44Sc would result in a structure identical to the 5th option recited in this claim (the first structure on pg. 20 of the pending claim set. Therefore, the combined teachings of Umbricht, Vaughn, and Benesova render claim 32 obvious.
Claims 1, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Vaughn in view of Prata (Prata, M. I. M.; et al., J. Inorg. Biochem., 2017) and Nonat (Nonat, A.; et al., Dalton Trans., 2009 – provided by applicant in IDS filed June 26, 2024).
As described above, Vaughn discloses the compounds H3mpatcn, H3bpatcn, and H3tpatcn, which are triaza-macrocycles modified with acetate and picolinate groups (pg. 334, Fig. 1). Vaughn teaches the radiolabeling of mpatcn with 44Sc (pg. 335, Radiolabeling with 44Sc; and pg. 336, Fig. 2). Vaughn further teaches the conjugation of an H3mpatcn derivative (picaga) to DUPA (pg. 338, Scheme 1) and radiolabeling this conjugate to prepare Sc(picaga)-DUPA (Fig. 5; and pg. 335, right column). Vaughn compares the performance of picaga-DUPA to DOTA-DUPA (Fig. 5) in radiolabeling properties and finds that 44Sc radiolabeling at room temperature is improved for picaga-DUPA compared to the DOTA-derivative analog (Fig. 6). Vaughn further teaches using 44Sc(picaga)-DUPA for PET-CT in mice (Fig. 7).
Vaughn does not teach a conjugate comprising a TACN derivative chelator containing both picolinate and phosphonate groups.
Prata teaches chelates of triaza macrocyclic chelators (pg. 8, Abstract). More specifically Prata compares the properties of gallium chelates of NOTA, NOTP, NO2AP, and NOA2P (pg. 9, Fig. 1). Prata also teaches the biodistribution of 67Ga-radiolabeled NO2AP and NOA2P in mice (pg. 13, Fig. 6). Prata indicates that both NO2AP and NOA2P have reduced kidney retention compared to NOTP, suggesting a correlation between total charge and kidney retention in vivo (pg. 13, right column, second paragraph). Prata describes that the gallium chelates of NOA2P and NO2AP are both highly stable in vivo and that the Ga(NOA2P) stability constant is higher than that of Ga(NOTA) and Ga(DOTA). Prata concludes that the introduction of phosphonate groups increases thermodynamic and kinetic stability in solution (pg. 14, Conclusions). Prata also suggests that the NOA2P and NO2AP could be used to optimize the design of 67/68Ga-radiolabeled bioconjugates for nuclear imaging (pg. 14, left column, last paragraph).
Nonat teaches gadolinium complexes of tripodal picolinate TACN-core chelators (pg. 8033, Abstract). More specifically, Nonat compares TACN derivative chelators containing two picolinate arms attached to TACN nitrogens and the remaining nitrogen being modified either by a carboxylic acid (bpatcn or ebpatcn) or a phosphonate (pbpatcn) (pg. 8034, Scheme 1). Nonat teaches that the stability constant of the gadolinium complex with the phosphonate-containing pbpatcn indicates lower free metal at physiological pH than for the analogous carboxylic acid containing bpatcn chelator (pg. 3039, right column, first paragraph). Nonat notes that the replacement of one acetate arm of bpatcn with a phosphonate leads to an increase in the thermodynamic stability of the corresponding gadolinium chelate (pg. 8039, right column, third paragraph). Nonat also reports that the phosphonate substitution increased the exchange rate of the coordinated water molecule of the gadolinium complex, resulting in a measured value in the range of predicted optimum values (pg. 8045, left column, last paragraph).
A person of ordinary skill in the art would recognize that each of Vaughn, Prata, and Nonat teach TACN-core chelating compounds and metal complexes thereof. It would also be recognized that both Vaughn and Nonat teach picolinate-containing chelators and that both Prata and Nonat teach phosphonate-containing chelators. It would be understood that these references on the whole suggest that the pendant arms coming off the nitrogens of the TACN ring can be either carboxylic acid group, picolinic acid, or phosphonate groups and that each of these groups generally perform the same function, enabling the chelation of metals.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the picaga-DUPA conjugate of Vaughn by substituting the carboxylic acid groups with one or two phosphonate groups, as taught by Prata and Nonat because the phosphonate groups are known in the macrocyclic metal chelator art to be alternative chelator arms that serve the same purpose as the carboxylic acid groups and can be predictably interchanged (MPEP § 2143(I)(B)). This combination would yield the predictable result of a PSMA-targeting chelator conjugate according to either of the following structures.
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A person of ordinary skill in the art would have had a reasonable expectation of success in making this modification because Nonat teaches the incorporation a phosphonate in place of a carboxylic acid in a picolinic acid containing chelator and Prata teaches the substitution of multiple carboxylic acid groups with phosphonate groups in a chelator. Furthermore, Prata suggests including the phosphonate-containing chelators in radiolabeled bioconjugates for nuclear imaging (pg. 14, left column, last paragraph). Prata even suggests further substituting a remaining acetate group with an amino acid, such as is done in NODAGA, to enable such conjugation (which is also how Vaughn modified mpatcn to make picaga (pg. 338, Functionalization of mpatcn:picaga)). This would result in the structure of Formula (D).
The skilled artisan would have been motivated to make this modification because both Prata and Nonat teach that substitution of carboxylic acids for phosphonates results in increased stability of metal complexes. This increased stability would be desirable in a PSMA-targeting conjugate, as the conjugate is to be used in living organisms, where breakdown of the chelator-metal complex would result in toxic free metal release, which should be minimized.
Regarding claim 1, the structure of Formula (D) reads on the compound of claim 1 wherein Y4 is -H; Y1 is alkyl-P(O)(OH)2; Y2 is alkylheteroaryl-CO2H; and Y3 is Z1-L(A) wherein Z1 is the first provided structure in its corresponding definition in claim 1 and the Y5 moiety within it is -CO2H, L is a chemical linker group, and A is a PSMA targeting ligand. Additionally, the structure of Formula (E) reads on the compound of claim 1 wherein Y4 is -H; Y1 is alkyl-P(O)(OH)2; Y2 is alkylheteroaryl-CO2H; and Y3 is Z1-L(A) wherein Z1 is the first provided structure in its corresponding definition in claim 1 and the Y5 moiety within it is -P(O)(OH)2, L is a chemical linker group, and A is a PSMA targeting ligand. Therefore, the combined teachings of Vaughn, Prata, and Nonat render claim 1 obvious.
Regarding claim 21, the structure of Formula (D) reads on the compound of claim 21 wherein Y1 is –CH2-P(O)(OH)2 (the third option recited in paragraph b)) and Y2 is the 4th option in paragraph b) (picolinic acid arm) (the first option in the second line of paragraph b)). Formula (D) also reads on the compound of claim 21 wherein Z1 is the first provided option in paragraph c) (carboxylic acid). Additionally, the structure of Formula (E) reads on the compound of claim 21 wherein Y1 is –CH2-P(O)(OH)2 (the third option recited in paragraph b)) and Y2 is the 4th option in paragraph b) (picolinic acid arm) (the first option in the second line of paragraph b)). Formula (E) also reads on the compound of claim 21 wherein Z1 is the second provided option in paragraph c) (phosphonate). Therefore, the combined teachings of Vaughn, Prata, and Nonat render claim 21 obvious.
Regarding claim 22, the structure of Formula (D) is identical to that of the second listed option in this claim. Additionally, the structure of Formula (E) is identical to that of the third listed option in this claim. Therefore, the combined teachings of Vaughn, Prata, and Nonat render claim 22 obvious.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6, 12-17, 20, 21, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 12, 23, 30, 33, 36, 42, 55, and 59 of copending Application No. 17/253,307 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to TACN-core chelators containing Y, L, and A groups with similar or identical structures.
Regarding instant claim 15, conflicting claim 1 of the copending application is drawn to metal complexes wherein the metal is Scandium-44, Scandium-47, or Scandium-43, which are all within the scope of instant claim 15. Additionally, the definitions for the Y-groups on the TACN core in conflicting claim 1 lie within the scope of structural options within instant claim 1. In the conflicting claims of the ‘307 application, Y4 (as defined in the instant claims) is -H. Furthermore, the presence of a metal complex of a compound of instant claim 1 also therefore reads on instant claim 1, as the same organic molecule must be present.
Additionally, the conflicting claims of the ‘307 copending application include embodiments wherein the A group as defined is conflicting claim 1 is a PSMA targeting ligand identical to that of at least instant claims 22 and 32.
The conflicting claims of the ‘307 application allow for Y1 and Y2 to be -H, alkylheteroaryl, alkyl-CO2H, alkylheteroaryl-CO2H, alkyl-CO2R4, or alkylheteroaryl-COR4, which is within the scope of the instant claims. Conflicting claim 36 even further narrows the Y1 and Y2 structures to include -CH2-CO2H and picolinic acid structures, as reads on at least instant claims 1, 13, 16, 20, and 21.
Additionally, Z1 in the copending application is defined similar to Z1 in the instant application, with narrower embodiments such as that in conflicting claim 23 reading on the Y5-containing embodiment of instant claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/E.P.M./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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