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 the Application
Applicant’s amendments of claim(s) 4-12, 14, and 18 in the reply filed on 01/30/2024 is acknowledged.
Claims 1-18 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to because of the following:
Figures 1-4 axis labels and spectrum are blurry and difficult to read.
Figures 7-11 axis labels are blurry and difficult to read.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant specification teaches L1 is a single bond or -CO-(CH2)m1-CO- and L2 is a single bond or -NH-(CH2)m2-CH(COOH)-NH-.
When both L1 and L2 are single bonds, the instant specification does not offer sufficient description of the connection of two single bonds to each other. Furthermore, the instant specification does not offer sufficient description of the of the common structural elements or identifying characteristics that constitute the structural connectivity of L1 and L2 when they are both single bonds. Furthermore, the instant specification does not indicate that the inventors have possession of the details of the structural elements that would comprise these distinguishing characteristics.
When L1 is -CO-(CH2)m1-CO- and L2 is a single bond, the instant specification does not offer sufficient description of the connection of the two carbonyl groups connected by the L2 single bond. Furthermore, the instant specification does not offer sufficient description of the of the common structural elements or identifying characteristics that constitute the structural connectivity of L1 and L2. Furthermore, the instant specification does not indicate that the inventors have possession of the details of the structural elements that would comprise these distinguishing characteristics.
When L1 is a single bond and L2 is - NH-(CH2)m2-CH(COOH)-NH-, the instant specification does not offer sufficient description of the connection of the two amine groups connected by the L1 single bond. Furthermore, the instant specification does not offer sufficient description of the of the common structural elements or identifying characteristics that constitute the structural connectivity of L1 and L2. Furthermore, the instant specification does not indicate that the inventors have possession of the details of the structural elements that would comprise these distinguishing characteristics.
A person of ordinary skill in the art would appreciate that there are many different structural elements that would constitute L1 and L2 to facilitate the functions recited in the instant claims. However, the instant specification is silent as to which structural elements the inventor has determined to be sufficient to characterize L1 and L2. Therefore, the instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how the inventor intended what features constitute the L1 and L2 to allow the function recited in the instant claims.
Claim Interpretation
Claims 1-2 and 16 recite L1 is a single bond or -CO-(CH2)m1-CO- and L2 is a single bond or -NH-(CH2)m2-CH(COOH)-NH-.
When L1 and L2 are both single bonds, the examiner notes that the specification has examples of structures that contain a single bond between the groups bracketed by p1 and p2 (pg 20, para [0056]; pg 25, para [0070]). Therefore, for the purposes of examination, the examiner interprets when L1 and L2 are both single bonds that L1 and L2 are not two separate single bonds but form one single bond between bracketed groups p1 and p2. Therefore, any prior art that reads on this interpretation reads on this claim.
When L1 is -CO-(CH2)m1-CO- and L2 is a single bond, or when L1 is a single bond and L2 is - NH-(CH2)m2-CH(COOH)-NH-, the examiner notes the specification has no examples of either feature. However, the examiner further notes that the specification has examples of when L1 is -CO-(CH2)m1-CO- and L2 is - NH-(CH2)m2-CH(COOH)-NH-. Therefore, for the purposes of examination, the examiner will interpret this claim as either both L1 and L2 form a single bond, or L1 is -CO-(CH2)m1-CO- and L2 is - NH-(CH2)m2-CH(COOH)-NH-. Therefore, any prior art that reads on this interpretation reads on this claim.
Claims 16 and 18 recite Y is a boryl group (-B(OH)2) or its ester group. The examiner notes that the specification gives examples of possibilities of boryl esters (pg 13, para [0032]-[0033]) as to the meaning of the range of possibilities in “ester group”. However, this is insufficient to define the range of “ester groups” in the claim. For the purposes of examination, the examiner interprets “ester group” to refer to any alkyl group used to make a boronic ester. Therefore, any prior art with any kind of boronic ester reads on this claim.
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) 1-2, 4-5, 7-8, 11, and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cardinale, J.; et al. (Cardinale, J.; Schaefer, M.; Kopka, K.; Eder, M.; Bauder-Wuest, U.; Eisenhut, M.; Benesova, M.; Haberkorn, U.; Giesel, F. L., US 10,815,200 B2) and Shirakami, Y.; et al. (Shirakami, Y.; Ikeda, H.; Kanai, Y.; Shimosegawa, E.; Hatazawa, J.; Watabe, T.; Kaneda, K., US 2020/0369578 A1, as cited in the IDS filed on 30 January 2024).
Cardinale, J.; et al. (hereafter referred to as Cardinale) is drawn to a radiopharmaceuticals for use in prostate cancer (title; abstract). Cardinale teaches a radiolabeled compound (pg 25, Formula I) with motivation to adjust the linker region to improve rumor targeting properties (pg 25, col 3, lines 1-3).
As to claim 1, Cardinale teaches a radiolabeled compound represented by Formula (I) (pg 51, claim 1; claim 5, compound numbers 1-3 and 9-10) where A1 and A2 are each independently an amino acid residue (pg 52, claim 1, Formula I, AS) and L1 and L2 are a single bond (claim 5, compound numbers 1-3 and 9-10) and Ar is a C6 aryl group (pg 52, claim 1, lines 15-20).
Cardinale does not teach R3 is a C1-6 alkyl group or a hydroxy group.
Cardinale does not teach X is a radionuclide selected from 211At, 210At, 131I, 125I, 124I, 123I, 77Br and 76Br.
Shirakami, Y.; et al. (hereafter referred to as Shirakami) is drawn to a method of producing radiolabled compounds (title; abstract). Shirakami teaches a method of production (pg 6, para [0199] – pg 8, para [0212), various aryl groups (claim 1, line 5), aryl substituents (radionuclides (claim 1, line 7).
Regarding R3, Shirakami teaches the aryl group has substituents (claim 1, line 5).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding X, Shirakami teaches X is 211At, 210At , 123I, 124I, 125I, or 131I (claim 1, line 7).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 2, Cardinale teaches L1 and L2 are a single bond (claim 5, compound numbers 1-3 and 9-10).
As to claim 4, Cardinale teaches glutamic acid (pg 30, col 13, line 15-25).
As to claim 5, Cardinale teaches p1 is an integer of 1-5 (pg 52, claim 1, Formula I, m). The claimed range of 0 to 2 overlaps with this range. 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).
As to claim 7, Cardinale teaches p2 is an integer of 1-5 (pg 52, claim 1, Formula I, m). The claimed range of 0 to 2 overlaps with this range. 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).
As to claim 8, Shirakami teaches a phenyl (pg 1, para [0018]; pg 2, para [0036]).
As to claim 11, Cardinale teaches a pharmaceutically acceptable salt (col 37, lines 14-20; claim 3).
As to claim 14, Cardinale teaches a diagnostic agent for PSMA expressing cancers (title; abstract; col 56, line 20-51; claim 8).
As to claim 15, Cardinale teaches the tumor or cancer expressing PSMA is prostate cancer (title; abstract; col 56, line 20-51; claim 8).
As to claim 16, Cardinale teaches a radiolabeled compound represented by Formula (I) (pg 51, claim 1; claim 5, compound numbers 1-3 and 9-10) where A1 and A2 are each independently an amino acid residue (pg 52, claim 1, Formula I, AS) and L1 and L2 are a single bond (claim 5, compound numbers 1-3 and 9-10) and Ar is a C6 aryl group (pg 52, claim 1, lines 15-20).
Cardinale does not teach R3 is a C1-6 alkyl group or a hydroxy group.
Cardinale does not teach X is a radionuclide selected from 211At, 210At, 131I, 125I, 124I, 123I, 77Br and 76Br.
Cardinale does not teach Y is a boryl group (-B(OH)2) or its ester group
Regarding R3, Shirakami teaches the aryl group has substituents (claim 1, line 5).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding X, Shirakami teaches X is 211At, 210At , 123I, 124I, 125I, or 131I (claim 1, line 7).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding Y, Shirakami teaches Y is a boryl group (-B(OH)2) or its ester group (pg 2, para [0021]).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 17, Shirakami teaches Y is a boryl group (-B(OH)2) or 4,4,5,5,-tetramethyl-1,3,2-dioxaboran-2-yl group (pg 4, para [0107]).
As to claim 18, Cardinale teaches a radiolabeled compound represented by Formula (I) (pg 51, claim 1; claim 5, compound numbers 1-3 and 9-10) where A1 and A2 are each independently an amino acid residue (pg 52, claim 1, Formula I, AS) and L1 and L2 are a single bond (claim 5, compound numbers 1-3 and 9-10) and Ar is a C6 aryl group (pg 52, claim 1, lines 15-20).
Cardinale does not teach R3 is a C1-6 alkyl group or a hydroxy group.
Cardinale does not teach X is a radionuclide selected from 211At, 210At, 131I, 125I, 124I, 123I, 77Br and 76Br.
Cardinale does not teach Y is a boryl group (-B(OH)2) or its ester group.
Cardinale does not teach the step of transforming Y to X.
Regarding R3, Shirakami teaches the aryl group has substituents (claim 1, line 5).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding X, Shirakami teaches X is 211At, 210At , 123I, 124I, 125I, or 131I (claim 1, line 7).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding Y, Shirakami teaches Y is a boryl group (-B(OH)2) or its ester group (pg 2, para [0021]).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding transforming Y to X, Shirakami teaches the step 1 of reacting a compound with a boryl group with a reagent selected from an alkali metal iodide, alkali metal bromide, N-bromosuccinimide, N-chlorosuccinimide, and hydrogen peroxide in water to obtain the radiolabeled compound represented X (pg 7, para [0203] – pg 8, para [0212]; claim 1).
Claim(s) 3 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cardinale and Shirakami in further view of Pomper, M. G.; et al. (Pomper, M. G.; Mease, R.; Ying, C.; Ray, S.; Zalutsky, M.; Vaidyanathan, G., WO 2017/070482 A1, as cited in the IDS filed on 30 January 2024) The teachings of Cardinale and Shirakami as applied above in the previous rejections are incorporate in this rejection.
Pomper, M. G.; et al. (hereafter referred to as Pomper) is drawn to PSMA bindings scaffolds with radiolables for PSMA expressing cells or tumors (title; abstract) where the PSMA binding scaffolds are compounds containing aryl groups, PSMA binding moieties, linker groups, and radiolabels (pg 2, Formula 1), synthetic methods (pg 46, Scheme 1; pg 47, Scheme 2; pg 48, Scheme 3).
As to claim 3, Cardinale teaches where L1 and L2 are a single bond.
Cardinale does not teach where L1 is -CO-(CH2)m1-CO- and L2 is -NH-(CH2)m2-CH(COOH)-NH-.
Pomper teaches L1 is -CO-(CH2)m1-CO- and L2 is -NH-(CH2)m2-CH(COOH)-NH- (pg 2, Formula 1; pg 9, structures; pg 10, structures). See example structure reproduced below (annotations added for clarity) where L2 is in the left box and L1 is in the right oval (pg 9, last structure).
PNG
media_image1.png
480
1208
media_image1.png
Greyscale
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 12, Pomper teaches a therapeutic agent for a tumor or cancer expressing protstate-specific membrane antigen (title; abstract; pg 2, Formula 1; pg 46, Scheme 1; pg 47, Scheme 2; pg 48, Scheme 3; claims 7-20).
As to claim 13, Pomper teaches the tumor or cancer expressing PSMA is prostate cancer (title; abstract; pg 3, lines 10-13; pg 20, lines 1-3).
Claim(s) 6 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cardinale, Shirakami and Pomper in further view of Kung, H. F.; et al. (Kung, H. F.; Zhihao, Z.; Ploessl, K.; Choi, S. R., WO 2020/220023 A1, as cited in the IDS filed on 28 May 2026). The teachings of Cardinale, Shirakami, and Pomper as applied above in the previous rejections are incorporate in this rejection.
As to claim 6, Cardinale teaches any amino acid (includes glycine) as -CO-A1-NH- (pg 52, claim 1, Formula I, AS).
Cardinale does not explicitly teach glycine.
Kung, H. F.; et al. (hereafter referred to as Kung) is drawn to radiopharmaceutical compounds and compositions that bind to PSMA as diagnostics and therapeutics (title; abstract). Kung teaches the synthesis of the compound and compositions (pg 39, para [0095]; pg 40, Scheme 9) and compounds (pg 11, Scheme 7; pg 30, para [0037], structures; pg 64, Table 1).
Regarding glycine, Kung teaches glycine as an amino acid for use in PSMA-binding radio-compounds (pg 6, para [0011], Formula I; pg 11, para [0025], Scheme 7, compound A; pg 12, para [0026], Formula I and pg 13, compound T11; pg 34, para [0084], line 4).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
As to claim 9, Kung teaches R1 and R2 are hydrogen atoms (pg 15, para [0028], line 7, structure reproduced below).
PNG
media_image2.png
226
437
media_image2.png
Greyscale
As to claim 10, Kung teaches q is an integer from 1-4 (pg 15, para [0028], line 8).
The claimed range of 1-3 lies within this range. 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).
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.
U.S. Patent No. 11,731,917
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-14 of U.S. Patent No. 11,731,917 in view of Cardinale, Shirakami, Pomper, and Kung.
The instant claims are drawn to a radiolabeled compound of formula (I) and its precursor, formula (II), with independently selected amino acid residues, and a At, I, or Br radionuclide with it can be used for tumor PSMA expressing cancers and a method of making formula (I) from formula (II).
The conflicting claims of U.S. Patent No. 11,731,917 (hereafter referred to as ‘917) are drawn to a method of producing a radiolabeled aryl compound by transforming a boronic acid to a radioisotope (At), for a target molecule overexpressed in a cancer cell, with an aryl group with a radioisotope or boronic acid and the aryl group has optional halogens.
The claims of ‘917 do not teach the amino acid residues.
The conflicting claims of ‘917 do not teach the targeting moiety.
The conflicting claims of ‘917 do not teach the linkers.
Regarding the amino acid residues, Kung teaches glycine as an amino acid for use in PSMA-binding radio-compounds (pg 6, para [0011], Formula I; pg 11, para [0025], Scheme 7, compound A; pg 12, para [0026], Formula I and pg 13, compound T11; pg 34, para [0084], line 4).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Regarding glutamic acid, Cardinale teaches glutamic acid (pg 30, col 13, line 15-25).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Regarding the targeting moiety, Cardinale teaches a radiolabeled compound represented by Formula (I) with a PSMA targeting moiety for PSMA overexpressing cancers and tumors (pg 51, claim 1; claim 5, compound numbers 1-3 and 9-10).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding the linkers, Pomper teaches L1 is -CO-(CH2)m1-CO- and L2 is -NH-(CH2)m2-CH(COOH)-NH- (pg 2, Formula 1; pg 9, structures; pg 10, structures). See example structure reproduced below (annotations added for clarity) where L2 is in the left box and L1 is in the right oval (pg 9, last structure).
PNG
media_image1.png
480
1208
media_image1.png
Greyscale
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
U.S. Application Number 18/844,320
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 13-18 of copending Application No. 18/844,320 in view of Cardinale, Shirakami, Pomper, and Kung.
This is a provisional nonstatutory double patenting rejection.
The instant claims are drawn to a radiolabeled compound of formula (I) and its precursor, formula (II), with independently selected amino acid residues, and a At, I, or Br radionuclide with it can be used for tumor PSMA expressing cancers and a method of making formula (I) from formula (II).
The conflicting claims of U.S. application number 18/844,320 (hereafter referred to as ‘320) are drawn to a method of producing an aryl compound labeled with a radionuclide (At, I, Br, and F), and teaches an aryl group with amino acids, peptide, or protein.
The conflicting claims of ‘320 do not teach the specific linking of the amino acids.
The conflicting claims of ‘320 do not teach the targeting moiety.
The conflicting claims of ‘320 do not teach the linker.
The conflicting claims of ‘320 do not teach the boryl precursor.
Regarding the amino acids, Kung teaches glycine as an amino acid for use in PSMA-binding radio-compounds (pg 6, para [0011], Formula I; pg 11, para [0025], Scheme 7, compound A; pg 12, para [0026], Formula I and pg 13, compound T11; pg 34, para [0084], line 4).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Regarding glutamic acid, Cardinale teaches glutamic acid (pg 30, col 13, line 15-25).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Regarding the targeting moiety, Cardinale teaches a radiolabeled compound represented by Formula (I) with a PSMA targeting moiety for PSMA overexpressing cancers and tumors (pg 51, claim 1; claim 5, compound numbers 1-3 and 9-10).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding the linker, Pomper teaches L1 is -CO-(CH2)m1-CO- and L2 is -NH-(CH2)m2-CH(COOH)-NH- (pg 2, Formula 1; pg 9, structures; pg 10, structures). See example structure reproduced below (annotations added for clarity) where L2 is in the left box and L1 is in the right oval (pg 9, last structure).
PNG
media_image1.png
480
1208
media_image1.png
Greyscale
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding the boryl precursor, Cardinale teaches a radiolabeled compound represented by Formula (I) (pg 51, claim 1; claim 5, compound numbers 1-3 and 9-10) where A1 and A2 are each independently an amino acid residue (pg 52, claim 1, Formula I, AS) and L1 and L2 are a single bond (claim 5, compound numbers 1-3 and 9-10) and Ar is a C6 aryl group (pg 52, claim 1, lines 15-20).
Cardinale does not teach R3 is a C1-6 alkyl group or a hydroxy group.
Cardinale does not teach X is a radionuclide selected from 211At, 210At, 131I, 125I, 124I, 123I, 77Br and 76Br.
Cardinale does not teach Y is a boryl group (-B(OH)2) or its ester group.
Cardinale does not teach the step of transforming Y to X.
Regarding R3, Shirakami teaches the aryl group has substituents (claim 1, line 5).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding X, Shirakami teaches X is 211At, 210At , 123I, 124I, 125I, or 131I (claim 1, line 7).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding Y, Shirakami teaches Y is a boryl group (-B(OH)2) or its ester group (pg 2, para [0021]).
A person having ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights