Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 1/7/2026 is acknowledged.
Claims 15-29, 36, and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II-IV, and there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/7/2026.
Status of Claims
Cancelled: 7-13, 30-35, 37-49
Withdrawn: 15-29, 36, 50
Examined Herein: 1-6, 14
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in AU2020903727 on 10/14/2020 and PCT/AU2021/051203 on 10/14/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/1/2023, 8/1/2023, 5/2/2024, 10/3/2024, 8/6/2025, and 12/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 4/12/2023, 6/27/2023, and 8/30/2023 are accepted.
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 1-4 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Shon (Preparation of a Dithiol-Reactive Probe for PET Imaging of Cell Death, 5/9/2019, Functional Disulphide Bonds: Methods and Protocols, Methods in Molecular Biology, vol. 1967).
With respect to claim 1, Shon discloses a compound according to Formula (I):
PNG
media_image1.png
415
483
media_image1.png
Greyscale
[Shon, Page 296, Figure 1]
Wherein,
A is -As(OH)2,
each of R1, R2, R3 and R4 is independently H,
R5 is -NHCH2COOH, and
Z is a therapeutic radioisotope, 68Ga, thus meeting the limitations of claim 1.
With respect to claim 2, Shon discloses each of R1, R2, R3 and R4 is independently H, thus meeting the limitations of claim 2.
With respect to claim 3, Shon discloses R5 is -NHCH2COOH, thus meeting the limitations of claim 3.
With respect to claim 4, Shon discloses a compound according to Formula (Ia):
PNG
media_image2.png
605
704
media_image2.png
Greyscale
[Shon, Page 296, Figure 1]
Wherein,
A is -As(OH)2, and
Z is a therapeutic radioisotope, 68Ga, thus meeting the limitations of claim 4.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Shon, as applied to claim 1-4 above, and further in view of Malicet (US 2019/0351079 A1, Published 11/21/2019).
With respect to claim 1, Shon discloses the teachings above.
Shon does not disclose Z is 177Lu, 67Cu, 90Y, 186Re, or 188Re.
However, with respect to claim 5 and 6, Malicet discloses several compounds selected from 68Ga-NODAGA, 90Y-NODAGA, and 177Lu-NODAGA conjugated to a peptide. [Malicet, 0078, 0091]
Malicet further discloses 68Ga has a short half-life (68 minutes), whereas 90Y and 177Lu has a longer half-life (between 1 to 75 days). [Malicet, 0069-0070] Malicet also discloses 90Y and 177Lu are preferred radionuclides for use in radiotherapy. [Malicet, 0070]
Modifying the compound disclosed by Shon by replacing the therapeutic radioisotope (68Ga) with 90Y or 177Lu results in the compound of claim 5 and/or 6.
It would be obvious to one of ordinary skill in the art to modify the compound disclosed by Shon by replacing the therapeutic radioisotope (68Ga) with 90Y or 177Lu and have a reasonable expectation of success. Shon discloses a compound comprising 68Ga-NODAGA conjugated to a peptide, GSAO, wherein 68Ga is a therapeutic radionuclide. Malicet discloses several compounds comprising 68Ga-NODAGA, 90Y-NODAGA, or 177Lu-NODAGA conjugated to a peptide. Malicet further discloses 90Y and 177Lu are therapeutic radionuclides. Thus, Malicet establishes that 90Y and 177Lu are therapeutic radionuclides and that 68Ga, 90Y, or 177Lu may function as a therapeutic radionuclide in a NODAGA-peptide conjugate. The combined teachings of Shon and Malicet suggest that 90Y or 177Lu may function as the therapeutic radionuclide of the NODAGA-GSAO conjugate disclosed by Shon. Therefore, it is reasonable to expect the compound disclosed by Shon may be modified by replacing the therapeutic radioisotope (68Ga) with 90Y or 177Lu. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Malicet discloses that 68Ga has a short half-life (68 minutes), whereas 90Y and 177Lu has a longer half-life (between 1 to 75 days). [Malicet, 0069-0070] Therefore, one would have been motivated by the expectation that replacing the therapeutic radioisotope (68Ga) with 90Y or 177Lu could enable the compound disclosed by Shon to exhibit a longer half-life.
Claims 1-4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Shon, as applied to claim 1-4 above, and further in view of Hogg (US 2005/0101524 A1, Published 5/12/2005).
With respect to claim 1, Shon discloses the teachings above.
Shon does not disclose a pharmaceutical composition comprising the compound of claim 1.
However, with respect to claim 14, Hogg discloses a pharmaceutical composition an arsenoxide compound (e.g. GSAO) directly linked to an active agent (e.g. a radionucleotide and/or an imaging agent) and a pharmaceutically acceptable carrier, diluent and/or adjuvant. [Hogg, 0005, 0032, 0033, 0174, 0187, 0192, 0233]
Modifying the compound disclosed by Shon by combining the compound with a pharmaceutically acceptable carrier, diluent and/or adjuvant, thereby forming a pharmaceutical composition, results in the pharmaceutical composition of claim 14.
It would be obvious to one of ordinary skill in the art to modify the compound disclosed by Shon by combining the compound with a pharmaceutically acceptable carrier, diluent and/or adjuvant, thereby forming a pharmaceutical composition, and have a reasonable expectation of success. Shon discloses a conjugate comprising an arsenoxide compound, GSAO, linked to an active agent 68Ga-NODAGA. Hogg discloses a conjugate comprising an arsenoxide compound (e.g. GSAO) directly linked to an active agent (e.g. a radionucleotide and/or an imaging agent) and a pharmaceutical composition comprising said conjugate and a pharmaceutically acceptable carrier, diluent and/or adjuvant. Thus, Hogg establishes that a conjugate comprising an arsenoxide compound (e.g. GSAO) linked to an active agent may be combined with a pharmaceutically acceptable carrier, diluent and/or adjuvant to form a pharmaceutical composition. The combined teachings of Shon and Hogg suggest that the conjugate comprising GSAO directly linked to 68Ga-NODAGA disclosed by Shon may be combined with a pharmaceutically acceptable carrier, diluent and/or adjuvant to form a pharmaceutical composition. Therefore, it is reasonable to expect the compound disclosed by Shon may be modified by combining the compound with a pharmaceutically acceptable carrier, diluent and/or adjuvant. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II) In the instant case, Hogg discloses that adding a pharmaceutically acceptable carrier, diluent and/or adjuvant to the conjugate, enables the conjugate to be administered in several forms like, a capsules ointment, cream, lotion, eye drop, aerosol etc. [Hogg, 0237-0249] Therefore, one would have been motivated by the expectation that combining the compound disclosed by Shon with a pharmaceutically acceptable carrier, diluent and/or adjuvant, would enable the compound to be administered in several forms.
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 and 14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 14, and 16-18 of U.S. Patent No. 12,296,030 B2, in view of Scheinberg (US 2014/0308203 A1, Published 10/16/2014).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-3 of the instant application are drawn to the compound of Formula (I), wherein
A is -As(OH)2, each of R1, R2, R3 and R4 is independently H, R5 is -NHCH2COOH, and Z is a therapeutic radioisotope. Claim 4 of the instant application is drawn to the compound of Formula (Ia), wherein A is -As(OH)2 and Z is a therapeutic radioisotope. Claim 14 of the instant application is drawn to a pharmaceutical composition comprising the compound of Formula (I).
Claims 1, 2, 14, and 16-18 of the reference patent are drawn to the compound of Formula (Ia), wherein A is -As(OH)2 and Z is 64Cu, 68Ga, or 99mTc. Claim 14 of the reference patent is drawn to a pharmaceutical composition comprising the compound of Formula (I).
Scheinberg discloses 64Cu, 68Ga, and 99mTc are therapeutic radioisotopes. [Scheinberg, 0046]
Therefore, the embodiment of Formula (I) and (Ia) described above and in claims 1-4 of the instant application is drawn to the exact same compound as Formula (I) described in claims 1, 2, 14, and 16-18 of the reference patent. Accordingly, claim 14 of the instant application is drawn to the exact same pharmaceutical composition as claim 3 of the reference patent.
Claims 1-6 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 and 19 of U.S. Patent No. 12,296,030 B2, in view of Hogg.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-3 of the instant application are drawn to the compound of Formula (I), wherein A is -As(OH)2, each of R1, R2, R3 and R4 is independently H, R5 is -NHCH2COOH, and Z is a therapeutic radioisotope. Claim 4 of the instant application is drawn to the compound of Formula (Ia), wherein A is -As(OH)2 and Z is a therapeutic radioisotope. Claim 5 of the instant application is drawn to the compound of Formula (I), wherein A is -As(OH)2, each of R1, R2, R3 and R4 is independently H, R5 is -NHCH2COOH, and Z is a therapeutic radioisotope selected from 177Lu, 67Cu, 90Y, 186Re or 188Re. Claim 6 of the instant application is drawn to the compound of Formula (I), wherein A is -As(OH)2, each of R1, R2, R3 and R4 is independently H, R5 is -NHCH2COOH, and Z is a therapeutic radioisotope selected from 177Lu or 67Cu.
Claims 4 and 19 of the reference patent are drawn to the compound of Formula (IIa), wherein A is -As(OH)2.
Claims 1-6 of the instant application differs from claims 4 and 19 the reference patent in that Formula (I) and Formula (Ia) of the instant application further comprises a therapeutic radionuclide (Z), whereas Formula (IIa) of the reference patent does not comprise a “Z” moiety.
However, Hogg discloses a conjugate comprising an arsenoxide compound directly linked to at least one active agent including an imaging agent and/or a radionuclide selected from 67Cu, 90Y, 177Lu, 186Re, and 188Re. [Hogg, 0005, 0032, 0033, 0187, 0192, 0204]
Modifying the reference patent by adding a radionuclide selected from 67Cu, 90Y, 177Lu, 186Re, and 188Re to the imaging agent (NODAGA) of Formula (IIa) results in claim 1-6 of the instant application.
It would be obvious to one of ordinary skill in the art to modify the reference patent by adding a radionuclide selected from 67Cu, 177Lu, 90Y, 186Re, and 188Re to the imaging agent (NODAGA) and have a reasonable expectation of success. The reference patent is drawn to a compound according to Formula (IIa) comprising an arsenoxide compound (GSAO) linked to an imaging agent (NODAGA). Hogg discloses a conjugate comprising an arsenoxide compound (e.g. GSAO) directly linked to at least one active agent including an imaging agent and/or a radionuclide selected from 67Cu, 90Y, 177Lu, 186Re, and 188Re. Thus, Hogg establishes that a conjugate comprising an arsenoxide compound (e.g. GSAO) directly linked to an imaging agent may further comprise a radionuclide selected from 67Cu, 177Lu, 186Re, and 188Re. The combined teachings of the reference patent and Hogg suggest that the imaging agent (NODAGA) of the compound according to Formula (IIa) may further comprise a radionuclide selected from 67Cu, 90Y, 177Lu, 186Re, and 188Re. Therefore, it is reasonable to expect the reference patent may be modified by adding a radionuclide selected from 67Cu, 177Lu, 186Re, and 188Re to the imaging agent (NODAGA). One would have been motivated to do so to yield a compound of Formula (IIa) that is more desirable, as Hogg discloses 67Cu, 90Y, 177Lu, 186Re, and 188Re are therapeutic agents that may be delivered to apoptotic cells and their environ. [Hogg, 0001, 0027, 0028, 0204] Therefore, one would have been motivated by the expectation that adding a radionuclide/therapeutic agent selected from 67Cu, 90Y, 177Lu, 186Re, and 188Re to the imaging agent (NODAGA) of Formula (IIa) enables the agents to be delivered to apoptotic cells and their environ.
Claims 1, 2, and 14 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32 and 34 of copending Application No. 18/701,106 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1 and 2 of the instant application are drawn a compound according to Formula (I), wherein R5 is -OH. Claim 14 of the instant application is drawn to a pharmaceutical composition comprising compound of Formula (I).
Claim 32 of the reference application is drawn to a compound of Formula (III). Claim 34 of the reference application is drawn to a pharmaceutical composition comprising compound of Formula (III).
Claim 1 of the instant application and claim 32 of the reference application are drawn to the exact same compound when R5 of Formula (I) is OH and R7 and R8 of Formula (III) are H. Claim 2 of the instant application and claim 32 of the reference application are drawn to the exact same compound when R5 of Formula (I) is OH, R7 and R8 of Formula (III) are H, and R1, R2, R3, and R4 of Formula (I) and Formula (III) are H. Accordingly, claim 14 of the instant application and claim 34 of the reference application are drawn to the exact same composition when R5 of Formula (I) is OH and R7 and R8 of Formula (III) are H.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5 and 6 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32 of copending Application No. 18/701,106, in view of Scheinberg.
Claim 1 of the instant application is drawn a compound according to Formula (I), wherein R5 is -OH. Claim 5 of the instant application is drawn a compound according to Formula (I), wherein Z is 177Lu, 67Cu, 90Y, 186Re, or 188Re. Claim 6 of the instant application is drawn a compound according to Formula (I), wherein Z is 177Lu or 67Cu.
Claim 32 of the reference application is drawn to a compound of Formula (III).
Claim 1 of the instant application and claim 32 of the reference application are drawn to the exact same compound when R5 of Formula (I) is OH and R7 and R8 of Formula (III) are H.
In contrast, claim 5 and 6 of the instant application differs from claim 32 of the reference application in that claim 5 and 6 defines Z as 177Lu, 67Cu, 90Y, 186Re or 188Re and 177Lu or 67Cu, respectively, whereas claim 32 of the reference application defines Z only as a therapeutic radioisotope.
However, Scheinberg discloses 177Lu, 67Cu, 90Y are therapeutic radioisotopes. [Scheinberg, 0046]
Modifying the reference application by defining Z as 90Y, 177Lu, or 67Cu, results in claims 5 and 6 of the reference application.
It would be obvious to one of ordinary skill in the art to modifying the reference application by defining Z as 90Y, 177Lu, or 67Cu and have a reasonable expectation of success. Claim 32 of the reference application is drawn to a compound of Formula (III), which comprises a therapeutic radioisotope (Z). Scheinberg discloses 177Lu, 67Cu, 90Y are therapeutic radioisotopes. Thus, the combined teachings of the reference application and Scheinberg suggest that 177Lu, 67Cu, 90Y are therapeutic radioisotopes that may be comprised in the compound of Formula (III). Therefore, it is reasonable to expect the reference application may be modified by defining Z as 90Y, 177Lu, or 67Cu. One would have been motivated to do so because 90Y, 177Lu, or 67Cu are merely specific embodiments of therapeutic radioisotopes.
This is a provisional nonstatutory double patenting rejection.
Claims 1-6 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 37 of copending Application No. 19/172,178, in view of Hogg.
Claims 1-3 of the instant application are drawn to the compound of Formula (I), wherein
A is -As(OH)2, each of R1, R2, R3 and R4 is independently H, R5 is -NHCH2COOH, and Z is a therapeutic radioisotope. Claim 4 of the instant application is drawn to the compound of Formula (Ia), wherein A is -As(OH)2 and Z is a therapeutic radioisotope. Claim 5 of the instant application is drawn a compound according to Formula (I), wherein Z is 177Lu, 67Cu, 90Y, 186Re, or 188Re. Claim 6 of the instant application is drawn a compound according to Formula (I), wherein Z is 177Lu or 67Cu.
Claim 37 of the reference application is drawn to a similar compound.
Formula (I) and Formula (Ia) of claims 1-6 of the instant application differs from the compound of reference application in that Formula (I) and Formula (Ia) further comprises a therapeutic radionuclide (Z), whereas the compound of reference application does not comprise a “Z” moiety.
However, Hogg discloses a conjugate comprising an arsenoxide compound directly linked to at least one active agent including an imaging agent and/or a radionuclide selected from 67Cu, 90Y, 177Lu, 186Re, and 188Re. [Hogg, 0005, 0032, 0033, 0187, 0192, 0204]
Modifying the reference application by adding a radionuclide selected from 67Cu, 177Lu, 186Re, and 188Re to the imaging agent (NODAGA) of the compound results in claim 1-6 of the instant application.
It would be obvious to one of ordinary skill in the art to modify the reference application by adding a radionuclide selected from 67Cu, 177Lu, 90Y, 186Re, and 188Re to the imaging agent (NODAGA) of the compound and have a reasonable expectation of success. The reference application is drawn to a compound comprising an arsenoxide compound (GSAO) linked to an imaging agent (NODAGA). Hogg discloses a conjugate comprising an arsenoxide compound (e.g. GSAO) directly linked to at least one active agent including an imaging agent and/or a radionuclide selected from 67Cu, 90Y, 177Lu, 186Re, and 188Re. Hogg establishes that a conjugate comprising an arsenoxide compound (e.g. GSAO) directly linked to an imaging agent may further comprise a radionuclide selected from 67Cu, 177Lu, 186Re, and 188Re. Thus, the combined teachings of the reference patent and Hogg suggest that the imaging agent (NODAGA) of the compound of the reference application may further comprise a radionuclide selected from 67Cu, 90Y, 177Lu, 186Re, and 188Re. Therefore, it is reasonable to expect the reference application may be modified by adding a radionuclide selected from 67Cu, 90Y, 177Lu, 186Re, and 188Re to the imaging agent (NODAGA) of the compound. One would have been motivated to do so to yield a compound of Formula (IIa) that is more desirable. MPEP 2144(II) Hogg discloses 67Cu, 177Lu, 186Re, 90Y, and 188Re are therapeutic agents that may be delivered to apoptotic cells and their environ. [Hogg, 0001, 0027, 0028, 0204] Therefore, one would have been motivated by the expectation that adding a radionuclide/therapeutic agent selected from 67Cu, 177Lu, 90Y, 186Re, and 188Re to the imaging agent (NODAGA) of the compound enables the agents to be delivered to apoptotic cells and their environ.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618