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Claims 15-29, 36, and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II-IV, and there being no allowable generic or linking claim.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, 30-56
Withdrawn: 15-29
New: 57-59
Examined Herein: 1-6, 14, 57-59
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.
Withdrawn Rejections
The rejection of claims 1-4 under 35 U.S.C. 102(a)(1) and 102 (a)(2) over Shon is hereby withdrawn in view of Applicant’s amendments to claim 1, which narrow the scope of Z, and Applicant’s persuasive arguments that the claims as amended are no longer anticipated by Shon.
The rejection of claims 1-6 under 35 U.S.C. 103 over Shon and Malicet is hereby withdrawn in view of Applicant’s amendments to claim 1, which narrow the scope of Z, and Applicant’s persuasive arguments that the claims as amended are no longer obvious over Shon and Malicet.
The rejection of claims 1-4 and 14 on the ground of nonstatutory double patenting over claims 1-3, 14, and 16-18 of U.S. Patent No. 12,296,030 B2, in view of Scheinberg, is hereby withdrawn in view of Applicant’s amendments to claim 1, which narrow the scope of Z, and Applicant’s persuasive arguments that the claims as amended are no longer obvious over U.S. Patent No. 12,296,030 B2 and Scheinberg.
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, 14, and 57-59 are rejected under 35 U.S.C. 103 as being unpatentable over 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), in view of Hogg (US 2005/0101524 A1, Published 5/12/2005).
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,
Z is a radioisotope, 68Ga.
With respect to claim 2, Shon discloses each of R1, R2, R3 and R4 is independently H.
With respect to claim 3, Shon discloses that R5 is -NHCH2COOH.
With respect to claim 4 and 59, 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,
Z is a radioisotope, 68Ga.
Shon additionally discloses that GSAO may be radiolabeled with other radioisotopes, such as 111In and 67Ga, using chelators, such as DOTA or DTPA. [Shon, Page 296, Paragraph 1]
Shon does not disclose that Z is 177Lu, 67Cu, 90Y, 186Re, or 188Re.
However, with respect to claim 1, 4, 5, 6, and 57-59, Hogg discloses an arsenoxide compound, GSAO, linked to at least one active agent (or imaging agent), including, for example, DOTA, CHX-A, or DTPA, and radioisotopes, including 177Lu, 67Cu, 186Re, or 188Re. [Hogg, 0013, 0014, 0026-0028, 0033, 0067, 0181, 0186] Hogg further discloses the arsenoxide-chelator conjugates may be radiolabeled with therapeutic radioisotopes including 188Re, 177Lu, 90Y, or other radioisotopes well known to those skilled in the art. [Hogg, 0196]
With respect to claim 14, Hogg discloses a pharmaceutical composition comprising the arsenoxide compound (i.e., GSAO) directly linked to the at least one active agent (e.g., a radionuclide and/or an imaging agent) and a pharmaceutically acceptable carrier, diluent and/or adjuvant. [Hogg, 0005, 0032, 0033, 0174, 0187, 0192, 0233]
Moreover, Hogg discloses that the suitability of a radioisotope for therapeutic applications can be readily identified based on targeting kinetics and results from biodistribution studies. [Hogg, 0196]
Modifying the compound disclosed by Shon by replacing the radioisotope 68Ga with 177Lu, 67Cu, 186Re, 188Re, or 90Y results in the compound of claim 1 and 57.
Modifying the compound disclosed by Shon by replacing the radioisotope 68Ga with 177Lu results in the compound of claim 1, 5, 6, 57, and 58.
Modifying the compound disclosed by Shon by replacing the radioisotope 68Ga with 67Cu results in the compound of claim 1, 6, 57, and 59.
Modifying the compound disclosed by Shon by replacing the radioisotope 68Ga with 177Lu, 67Cu, 186Re, 188Re, or 90Y, and 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 replacing the therapeutic radioisotope, 68Ga, with 177Lu, 67Cu, 90Y, 186Re, or 188Re and have a reasonable expectation of success. Shon discloses the compound 68Ga-NODAGA-GSAO comprising an arsenoxide compound, GSAO, a chelating ligand, NODAGA, and a radioisotope for imaging, 68Ga. Shon further discloses that GSAO may be radiolabeled with other radioisotopes, such as 111In and 67Ga, using chelators, such as DOTA or DTPA. Hogg discloses an arsenoxide compound comprising GSAO, a chelating ligand, e.g., DOTA, DTPA, or CHX-A, and a radioisotope for therapeutic purposes, 177Lu, 90Y, or 188Re. In another embodiment, Hogg discloses an arsenoxide compound comprising GSAO, a first imaging agent (or active agent), e.g., a chelating ligand, such as DOTA, DTPA, or CHX-A, and a second imaging agent including 111In, 177Lu, 67Cu, 186Re, and 188Re. Thus, Shon and Hogg each independently establish that GSAO may be radiolabeled with various radioisotopes useful for detection, imaging. and/or therapeutic purposes, including, but not limited to, 177Lu, 67Cu, 90Y, 186Re, and 188Re, using chelating ligands such as NODAGA, DOTA, or DTPA. Accordingly, the combined teachings of Shon and Hogg reasonably suggest that 68Ga-NODAGA-GSAO disclosed by Shon may be alternatively radiolabeled with 177Lu, 67Cu, 90Y, 186Re, or 188Re using the chelating ligand NODAGA. 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 present case, Shon discloses that conjugation of the γ-glutamyl residue of GSAO with radioisotopes (i.e., 67Ga, 68Ga, and 111In) results in loss of its anti-angiogenic effect and gain in the ability to identify dying cells. Hogg discloses, in addition to 67Ga, 68Ga, and 111In, radioisotopes including 177Lu, 67Cu, 90Y, 186Re, or 188Re are also suitable for conjugation to GSAO for diagnostic, imaging, and/or therapeutic purposes. [Hogg, 0033, 0196] Hogg further discloses that the suitability of a radioisotope for therapeutic applications can be readily identified based on targeting kinetics and results from biodistribution studies. Therefore, one would have been motivated by the expectation that replacing the radioisotope, 68Ga, with 177Lu, 67Cu, 90Y, 186Re, or 188Re, would enable the NODAGA-GSAO compound disclosed by Shon to be used for diagnostic, imaging, and/or therapeutic purposes, the latter of which can be readily identified based on targeting kinetics and results from biodistribution studies.
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 the compound [radionuclide]-NODAGA-GSAO comprising an arsenoxide compound, GSAO, a chelating ligand, NODAGA, and a radionuclide. Hogg discloses an arsenoxide compound comprising GSAO, a chelating ligand (e.g., DOTA, DTPA, CHX-A), and a radioisotope (i.e., 177Lu, 90Y, or 188Re). Hogg further discloses a pharmaceutical composition comprising said conjugate and a pharmaceutically acceptable carrier, diluent, and/or adjuvant. Thus, Hogg demonstrates that a compound comprising GSAO, a chelating ligand, and a radionuclide disclosed by Shon can be combined with a pharmaceutically acceptable carrier, diluent, and/or adjuvant to form a pharmaceutical composition. Accordingly, the combined teachings of Shon and Hogg reasonably suggest that the [radionuclide]-NODAGA-GSAO 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 present 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 including as a capsule, 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 1-6, 14, and 57-59 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 14, and 16-19 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 1-6, 14 and 57-59 of the instant application and claims 1-4, 14, and 16-19 of the reference patent are drawn to substantially similar compounds and compositions. However, the reference patent differs from the instant application in that Z is 64Cu, 68Ga, 99mTc, or absent, rather than present and represented by 90Y, 177Lu, 67Cu, 186Re, or 188Re.
However, Hogg discloses an arsenoxide compound, GSAO, linked to at least one active agent (or imaging agent), including, for example, DOTA, CHX-A, or DTPA, and radioisotopes, including 177Lu, 67Cu, 186Re, 99mTc, or 188Re. [Hogg, 0013, 0014, 0026-0028, 0033, 0067, 0181, 0186] Hogg further discloses the arsenoxide-chelator conjugates may be radiolabeled with therapeutic radioisotopes including 64Cu, 188Re, 177Lu, 90Y, or other radioisotopes well known to those skilled in the art. [Hogg, 0196]
It would be obvious to one of ordinary skill in the art to modify the reference patent by labeling the compound with other radioisotopes including 90Y, 177Lu, 67Cu, 186Re, or 188Re because Hogg discloses that GSAO may be radiolabeled, with various radionuclides that are useful for detection, imaging and/or therapeutic purposes, including but not limited to, 64Cu, 99mTc, 177Lu, 67Cu, 90Y, 186Re, or 188Re. Therefore, one would have been motivated by the expectation that labeling the reference compound with other radioisotopes, including 177Lu, 67Cu, 90Y, 186Re, or 188Re, would enable the NODAGA-GSAO compound to be used for diagnostic, imaging, and/or therapeutic purposes, the latter of which can be readily identified based on targeting kinetics and results from biodistribution studies.
Claims 1-6, 14, and 57-58 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), in view of Hogg.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-6, 14 and 57-58 of the instant application and claims 32 and 34 of the reference application are drawn to substantially similar compounds and compositions. However, the reference application differs from the instant application in that Z is a therapeutic radioisotope, rather than 90Y, 177Lu, or 188Re.
However, Hogg discloses that 188Re, 177Lu, and 90Y are therapeutic radionuclides with which an arsenoxide-chelator conjugate may be radiolabeled. [Hogg, 0013, 0014, 0026-0028, 0033, 0067, 0181, 0186, 0196]
Accordingly, the instant claims are a sub-genus of the reference claims, such that the scope of the reference application overlaps with the scope of the instant application. However, it would be obvious to one of ordinary skill in the art to modify the reference claims to recite the sub-genus of the instant claims because one could at once envisage the therapeutic radionuclides disclosed by Hogg as a possible arrangement of the genus described in the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 14 and 57-59 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32 and 34 of copending Application No. 18/701,106, 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 1-6, 14 and 57-59 of the instant application and claims 32 and 34 of the reference application are drawn to substantially similar compounds and compositions. However, the reference application differs from the instant application in that Z is a therapeutic radioisotope, rather than 90Y, 177Lu, or 67Cu.
However, Scheinberg discloses that 177Lu, 67Cu, and 90Y are therapeutic radioisotopes. [Scheinberg, 0046]
Accordingly, the instant claims are a sub-genus of the reference claims, such that the scope of the reference application overlaps with the scope of the instant application. However, it would be obvious to one of ordinary skill in the art to modify the reference claims to recite the sub-genus of the instant claims because one could at once envisage the therapeutic radionuclides disclosed by Scheinberg as a possible arrangement of the genus described in the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 and 57-59 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.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-6 and 57-59 of the instant application and claim 37 of the reference applivation are drawn to substantially similar compounds. However, the reference application differs from the instant application in that Z is absent, whereas in the instant application it is present and represented by 90Y, 177Lu, 67Cu, 186Re, or 188Re.
However, Hogg discloses an arsenoxide compound, GSAO, linked to at least one active agent (or imaging agent), including, for example, DOTA, CHX-A, or DTPA, and radioisotopes, including 177Lu, 67Cu, 186Re, 99mTc, or 188Re. [Hogg, 0013, 0014, 0026-0028, 0033, 0067, 0181, 0186] Hogg further discloses the arsenoxide-ligand conjugates may be radiolabeled with therapeutic radioisotopes including 64Cu, 188Re, 177Lu, 90Y, or other radioisotopes well known to those skilled in the art. [Hogg, 0196]
It would be obvious to one of ordinary skill in the art to modify the reference application by labeling the compound with other radioisotopes including 90Y, 177Lu, 67Cu, 186Re, or 188Re because Hogg discloses that GSAO may be radiolabeled, with various radioisotopes that are useful for detection, imaging, and/or therapeutic purposes, including but not limited to 64Cu, 99mTc, 177Lu, 67Cu, 90Y, 186Re, or 188Re. Therefore, one would have been motivated by the expectation that labeling the compound with a radioisotope, including 177Lu, 67Cu, 90Y, 186Re, or 188Re, would enable the reference compound to be used for diagnostic, imaging, and/or therapeutic purposes, the latter of which can be readily identified based on targeting kinetics and results from biodistribution studies.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 6/5/2026 have been fully considered but they are not persuasive.
Applicant asserts “Ho Shon is silent regarding conjugates radiolabeled with a therapeutic a- or B-emitting radionuclide as specified in the instant claims.” [Remarks 6/5/2026, Page 9, Paragraph 2]
The instant claims are not drawn to any α-emitting radionuclides. Rather, they are drawn exclusively to β-emitting particles. Accordingly, Applicant’s succeeding arguments throughout the remarks drawn to α-emitting radionuclides are considered immaterial to the claimed invention and instant rejection.
Applicant’s arguments with respect to Malicet have been considered but are moot because the new ground of rejection does not rely on Malicet. [Remarks 6/5/2026, Page 9, Paragraph 3]
Applicant asserts “One of ordinary skill in the art would not have appreciated the challenges associated with uniting these features within the same compound and would not have been able to arrive at the compounds of the instant claims based on the art cited by the Examiner.” [Remarks 6/5/2026, Page 10 (whole) – Page 11, Paragraph 1]
Applicants' reliance on MPEP § 2141.02(III) is acknowledged but is ultimately insufficient to overcome the instant rejection. The instant claims are drawn to a compound, whereas Applicant's alleged discovery is drawn to preparing the claimed compound. Accordingly, the previously unrecognized challenges associated with preparing the claimed compound do not establish that the claimed compound, itself, is nonobvious, as the prior art otherwise suggests the claimed compound. Hogg contemplates radiolabeling a GSAO-containing compound with β-emitting therapeutic radionuclides, including 177Lu. In view of this teaching, a POSITA would have been motivated to label the compound disclosed by Shon with 177Lu.
Additionally, the pending claims do not recite the alleged solution to the radiolysis/ undesirable degradation products problem, or impart distinctive structural characteristics to the claimed compound as a result of discovering the claimed solution. Accordingly, the asserted discovery does not patentably distinguish the claimed compound from the from the combined teachings of Shon and Hogg. Particularly, Applicant asserts, “The fact that exposure of As(III) to 177Lu during the radiolabeling step caused the arsenic atom to oxidize to As(V) suggests that any purified radiolabeled product comprising As(lII) and 177Lu may possess stability issues.” However, this implicit acknowledgment that a final product, 177Lu-NODAGA-GSAO, could be obtained, albeit with progressive oxidation of the compound to the As(V) analog, further supports that the discovery does not establish that the claimed product is nonobvious. Rather, the alleged discovery pertains to the process used to prepare the claimed product.
Furthermore, a POSITA would not have been discouraged from further attempts to develop a therapeutic agent comprising NODAGA-GSAO radiolabeled with a β-emitter due to the problem of As(III) radiolysis or undesirable degradation products. The fact that experimentation is complex does not make it undue if a person of skill in the art routinely engages in such experimentation. MPEP 2103(IV)(B)(2). Even assuming, arguendo, the aforementioned problems required complex experimentation, Applicant has provided no teaching from Shon or Hogg that criticizes, discredits, or otherwise discourages radiolabeling the compound disclosed by Shon with a β-emitter. Applicant relies solely on their self-characterized experience, which does not constitute discouragement by the prior art and does not undermine the motivation to combine. Recognition of obstacles encountered while combining the prior art teachings to arrive at the claimed compound does not, by itself, establish that the compound would have been nonobvious.
Finally, Applicant’s discovery is limited to 177Lu while the instant claims are drawn to 177Lu, 67Cu, 90Y, 186Re and 188Re. Applicant has not established that the alleged problem is common to all β-emitting therapeutic radionuclides, nor has Applicant provided a reason why this alleged discovery should extend to all of the radionuclides encompassed by the claims. Therefore, the alleged discovery is not commensurate in scope with all of the pending claims.
Ultimately, the relevant inquiry is whether the claimed compound would have been obvious in view of the cited references, not whether Applicant was the first to appreciate the difficulties in preparing the compound or the solution to overcome them. The instant claims do not recite the solution to the problem allegedly discovered by the Applicant. Thus, the reliance on MPEP 2141.02(III) is insufficient to overcome the instant rejection.
First Rejection - US Patent No. 12,296,030 in view of Scheinberq
Applicant asserts “Claim 5 has not been rejected on the ground of nonstatutory obviousness type double patenting over the '030 patent in view of Scheinberg. Accordingly, claim 1 as amended herein is patentably distinct from the claims of the '030 patent. Claims 2-4 and 14, which depend from claim 1, are likewise patentably distinct from the claims of the '030 patent.” [Remarks 6/5/2026, Page 11, Paragraph 6 – Page 12, Paragraph 2]
Applicant’s arguments have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made over U.S. Patent No. 12,296,030 B2, in view of Hogg (cited above).
Second Rejection- US Patent No. 12,296,030, in view of Hogg and Fifth Rejection - US Patent Application No. 19/172,178, in view of Hogg
Applicant asserts “While Hogg does generally disclose certain α- or β- emitting radionuclides along with positron-emitting radionuclides, the reference is largely directed toward non-radiolabeled arsenoxide compounds. Indeed, the Examples of the Hogg are entirely focused on the synthesis and behavior of fluorescien or Cy™S.5 conjugates of GSAO or GSAA, not radiolabeled versions of GSAO or GSAA.” [Remarks 6/5/2026, Page 13, Paragraph 1][See also, Remarks 6/5/2026, Page 15 (whole)]
The use of references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. MPEP 2123(I). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. MPEP 2123(II). Accordingly, Hogg’s disclosure may not be limited to the Examples. The broader disclosure by Hogg teaches the use of β-emitting radionuclides to label GSAO and GSAA.
Applicant asserts “Pages 11-15 of Hogg show representative schemes for preparing Gd- or Tc-99m radiolabeled conjugates. However, no yield or radiochemical purity data is provided to validate that the radiolabeled compounds were actually synthesized.” [Remarks 6/5/2026, Page 13, Paragraph 1]
When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on the applicant to rebut the presumption of operability. MPEP 2121(I). Accordingly, providing yield or radiochemical data to validate that the radiolabeled compounds were actually synthesized is unnecessary, as Hogg clearly indicates the use of β-emitting radionuclides to label GSAO and GSAA.
Moreover, the presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art. Prophetic examples do not make the disclosure nonenabling. MPEP 2164.08(b). A POSITA could reasonably determine that using β-emitting radionuclides to label GSAO and GSAA is conceivable in view of Hogg.
Finally, even if a reference discloses an inoperative device, it is prior art for all that it teaches. MPEP 2121.01(II).
Applicant asserts “Further, the chelators taught in this section of the document are DOTA and DTPA, not NODAGA as instantly claimed. Given the different pore sizes and of these chelators, the skilled person would not expect that radionuclides capable of radiolabeling DOTA and DTPA would necessarily be suitable for use with NODAGA.” [Remarks 6/5/2026, Page 13, Paragraph 1]
Applicant continues to improperly limit the disclosure of Hogg to suggesting only the use of DOTA and DTPA as chelators. The broader disclosure of Hogg teaches the system incorporates an imaging agent, such as a fluorescent agent or an MRI agent (e.g., DOTA or DTPA). Thus, DOTA and DTPA are examples of representative MRI agents. The broader disclosure of Hogg contemplates imaging agents other than DOTA or DTPA.
Still, NODAGA is an art-recognized imaging agent, as are DOTA and DTPA. For example, Malicet discloses that 68Ga, 90Y, 111In, and 177Lu are suitable for radiolabeling DOTA, DOTAGA, NODAGA, and NOTA. [Malicet, US 2019/0351079 A1 (previously cited), 0091] Therefore, a POSITA would understand that some radionuclides capable of radiolabeling DOTA would be suitable for use with NODAGA. Accordingly, a POSITA in the art would be reasonably apprised of the radionuclides suitable for radiolabeling DOTA, DTPA, and NODAGA, respectively, and appreciate that these chelators are known to exhibit overlapping radionuclide compatibility.
Applicant asserts “Moreover, as submitted supra, prior to the filing date of the instant application, one of ordinary skill in the art would not have appreciated the challenges associated with uniting an arsenoxide group and an α- or β-emitting therapeutic radionuclide within the same compound and would not have been able to arrive at the compounds of the instant claims based on the references cited by the Examiner.” [Remarks 6/5/2026, Page 13, Paragraph 2]
As explained above, Applicants' reliance on MPEP § 2141.02(III) is acknowledged, but ultimately insufficient to overcome the instant rejection. The instant claims are drawn to a compound, whereas Applicant's alleged discovery is drawn to the preparation of the claimed compound. Accordingly, the previously unrecognized challenges associated with preparing the claimed compound do not establish that the claimed compound itself is nonobvious where the prior art otherwise suggests the claimed compound. The claims of the reference application are drawn to a radiolabeled GSAO-containing compound, and Hogg contemplates radiolabeling a GSAO-containing compound with β-emitting radionuclides. In view of these disclosures, a POSITA would have been motivated to label the compound of the reference application with β-emitting therapeutic radionuclides.
Furthermore, a POSITA would not have been discouraged from further attempts to develop a therapeutic agent comprising NODAGA-GSAO that is radiolabeled with an α- or β-emitter, due to the problem of As(III) radiolysis and undesirable degradation products. The fact that experimentation is complex does not make it undue if a person of skill in the art routinely engages in such experimentation. MPEP 2103(IV)(B)(2). Even assuming, arguendo, that the aforementioned problems required complex experimentation, Applicant has provided no teaching from the reference application or Hogg that criticizes, discredits, or otherwise discourages the radiolabeling of the reference compounds with a β-emitter. Applicant relies solely on their self-characterized experience, which does not constitute discouragement by the prior art and does not undermine the motivation to combine. Recognition of obstacles encountered while combining the prior art teachings to arrive at the claimed compound does not, by itself, establish that the compound would have been nonobvious.
Finally, Applicant’s discovery is limited to 177Lu, while the instant claims are drawn to 177Lu, 67Cu, 90Y, 186Re and 188Re. Applicant has not established that the alleged problem is common to all β-emitting radionuclides, nor has Applicant provided a reason why this alleged discovery should extend to all of the radionuclides encompassed by the claims. Therefore, the alleged discovery is not commensurate in scope with all of the pending claims.
Ultimately, the relevant inquiry is whether the claimed compound would have been obvious over the reference applications, in view of Hogg, and not whether the Applicant was first to appreciate the difficulties of preparing the compound or the solution for overcoming them. The instant claims do not recite the solution to the problem allegedly discovered by Applicant. Accordingly, the reliance on MPEP 2141.02(III) is insufficient to overcome the instant rejection.
Third Rejection- US Patent Application No. 18/701,106
Applicant asserts “Claim 5 has not been rejected on the ground of nonstatutory obviousness-type double patenting over the '106 application. Accordingly, claim 1 as amended herein is patentably distinct from the claims of the '106 application. Claims 2 and 14, which depend from claim 1, are likewise patentably distinct from the claims of the '106 application.” [Remarks 6/5/2026, Page 14, Paragraph 1]
Applicant’s arguments have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made over copending Application No. 18/701,106, in view of Hogg (cited above). [Remarks 6/5/2026, Page 14, Paragraph 1]
Fourth Rejection- US Patent Application No. 18/701,106 in view of Scheinberg
Applicant asserts “The instant application has a term filing date of October 14, 2021. The '106 application has a term filing date of October 14, 2022. Accordingly, once all other rejections are overcome, Applicant respectfully requests that the provisional double patenting rejection over the '106 application be withdrawn.” [Remarks 6/5/2026, Page 14, Paragraph 3-5]
The provisional NSDP is not the only rejection remaining in the instant application. Accordingly, the instant rejection is maintained for the reasons set forth in the OA of 2/5/2026. However, once the provisional NSDP is the only remaining rejection, proper procedure will be followed in accordance with the MPEP.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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