Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election without traverse of Group Ill and a first and second binding agent that is capable of binding to the extracellular domain of PSMA in the reply filed on 8/5/2024 is acknowledged. Applicant's election without traverse of an increase in PSA of at least 25% PSA from nadir (at least 5 ng/mL) in the reply filed on 2/7/2025 is acknowledged.
Claims 1, 3-11, 13-15, 17-19, and 21-22 withdrawn from further consideration pursuant to 37 CFR l.142(b) as being drawn to a nonelected Group I and 11, and there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/5/2024 and 2/7/2025.
Status of Claims
Cancelled: 2, 12, 16, 20, 23, 25, 31-35
Withdrawn: 1, 3-11, 13-15, 17-19, 21-22
Examined Herein: 24, 26-30, 36-41
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in PRO 61/153,132 on 2/17/2009, PCT/US10/24475 on 2/17/2010, 12/658,891 (PAT 10,517,969) on 2/17/2010, and CON 16/653,655 on 10/15/2009.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/14/2023 and 8/5/2024 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 1/19/2022 are accepted.
Withdrawn Rejections
All rejections of claims 31-35 are hereby withdrawn; their cancellation moots the rejection.
The rejection of claims 29 and 30 under 35 U.S.C. 112 (pre-AIA ), second paragraph, is hereby withdrawn in view of Applicant’s amendments to claim 29, which remove the parenthesis, thereby rendering the rejection moot.
The rejection of claims 24, 26-34 and 39-41 under pre-AIA 35 U.S.C. 102(a) and 102(b) over Bander is hereby withdrawn in view of Applicant’s amendments to claim 24, which now recites the limitation “wherein the second binding agent is 225Ac-J591,” and Applicant’s persuasive arguments that the claim is not anticipated by Bander, as amended.
Claim Objections
Claim 29 objected to because of the following informalities:
Claim 29 begins with an uncapitalized letter. Each claim must begin with a capital letter. MPEP 608.0l(m). Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 24, 26-30, 36-41 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bander (US 2004/0213791 A1, 10/28/2004).
With respect to claim 24, Bander discloses a method for treating cancer comprising: administering a labeled first binding agent, 111ln-DOTA-deJ591 or 177Lu-DOTA-deJ591, to a patient; [0522, 0553]
detecting a presence of the labeled first binding agent in a tissue in a bodily fluid (blood); [0522, 0530]
wherein:
the labeled first binding agent is capable of binding a domain of PSMA; [0014]
the presence of the labeled first binding agent is indicative of cancer; [0522, 0533]
the patient is selected for an administration of a therapeutic dose of a second binding
agent, 90Y-DOTA-deJ591 or 177Lu-DOTA-deJ591, if the labeled first binding agent is detected. [0519, 0522, 0552-0553][See also - 0518-0550, 0552-0594]
With respect to claim 26, Bander discloses the labeled first and second binding agents target substantially the same epitope of the extracellular domain of PSMA. [0013-0014]
With respect to claim 27, Bander discloses the labeled first binding agent is detected by MRI, CT or PET. [0410-0411, 0519, 0588]
With respect to claim 28, Bander discloses the patient is visually scored 2 weeks after the dose of the labeled first binding agent. [0408, 0529, 0560, 0589]
With respect to claim 29, Bander discloses if the patient has as an increase in PSA of at least 25% PSA from nadir or appearance of a new lesion, the second binding agent is not administered. [0510, 0539, 0527, 0541-0543, 0620-0621]
With respect to claim 30, Bander discloses the labeled first binding agent, 111ln-DOTA-deJ591 or 177Lu-DOTA-deJ591, which is an anti-PSMA antibody. [0018]
With respect to claims 39-41, Bander discloses that the cancer is prostate cancer. [0522, 0552]
Bander does not explicitly disclose that the second binding agent is 225Ac-J591 or that the patient is given an additional therapeutic agent.
However, with respect to claim 24, Bander discloses that the anti-PSMA antibody J591 may be coupled to radioisotopes useful as therapeutic agents, including 90Y, 177Lu, or 225Ac. [0145]
With respect to claim 36 and 37, Bander discloses the anti-PSMA antibody, J591, may be administered in combination with a cytotoxic agent including antimicrotubule agents, topoisomerase inhibitors, antimetabolites, mitotic inhibitors, alkylating agents, intercalating agents, agents capable of interfering with a signal transduction pathway, an agent that promotes apoptosis, or an agent that interferes with folate metabolism and radiation. [0164, 0165]
With respect to claim 36 and 38, Bander discloses the anti-PSMA antibody, J591, can be coupled to an additional therapeutic agent including a maytansinoid, Taxol, or Taxotere. [0163]
Modifying the methods disclosed by Bander by replacing the therapeutic radioactive isotope of the second binding agent, 177Lu and 90Y, with 225Ac, thereby forming 225Ac-DOTA-deJ591, results in the method of claim 24.
Modifying the methods disclosed by Bander by administering an additional therapeutic (cytotoxic) agent including antimicrotubule agents, topoisomerase inhibitors, antimetabolites, mitotic inhibitors, alkylating agents, intercalating agents, agents capable of interfering with a signal transduction pathway, an agent that promotes apoptosis, or an agent that interferes with folate metabolism and radiation results in the methods of claim 36 and 37.
Modifying the methods disclosed by Bander by administering an additional therapeutic agent including a maytansinoid, Taxol, or Taxotere, results in the methods of claim 36 and 38.
It would be obvious to one of ordinary skill in the art to modify the methods disclosed by replacing the therapeutic radioactive isotope of the second binding agent, 177Lu and 90Y, with 225Ac, thereby forming 225Ac-DOTA-deJ591 and have a reasonable expectation of success. Bander discloses a method comprising administering a second binding agent, [177Lu or 90Y]-DOTA-deJ591, consisting of an anti-PSMA antibody, J591, coupled to a therapeutic radioisotope, 90Y or 177Lu. Bander further discloses the anti-PSMA antibody may alternatively be coupled to another therapeutic radioisotope, 225Ac. In view of this express teaching, it is reasonable to expect that the second binding agent may comprise 225Ac as the therapeutic radioactive isotope coupled to DOTA-deJ591, thereby forming 225Ac-DOTA-deJ591. One would have been motivated to do so because substituting equivalents known for the same purpose when the equivalence is recognized in the art, is prima facie obvious. MPEP 2144.06. In the present case, Bander discloses 90Y, 177Lu, and 225Ac are each a therapeutic radioisotope that can be coupled to the anti-PSMA antibody. Accordingly, it is prima facie obvious to substitute one art-recognized therapeutic radioisotope that can be coupled to the PSMA antibody (90Y or 177Lu) for another (225Ac).
It would be obvious to one of ordinary skill in the art to modify the methods disclosed by Bander by administering an additional therapeutic agent (including antimicrotubule agents, topoisomerase inhibitors, antimetabolites, mitotic inhibitors, alkylating agents, intercalating agents, agents capable of interfering with a signal transduction pathway, an agent that promotes apoptosis, an agent that interferes with folate metabolism and radiation, a maytansinoid, Taxol, or Taxotere) and have a reasonable expectation of success. Bander discloses a method comprising administering a second binding agent comprising an anti-PSMA antibody, deJ591. Bander further discloses that the anti-PSMA antibody may be administered in combination with the aforementioned agents. In view of this express teaching, it is reasonable to expect that an additional therapeutic agent may be administered in combination with the therapeutic agent comprising deJ591. One would have been motivated to do so because Bander discloses that combining the anti-PSMA antibody with an additional therapeutic agent makes treatment more effective. [0402] Bander further discloses the aforementioned therapeutic (cytotoxic) agents are capable of treating or preventing a non-prostatic disorder when administered in an effective amount in combination with an anti-PSMA antibody. [0164] Therefore, one would have been motivated by the expectation that administering an additional therapeutic agent would render the treatment method disclosed by Bander more effective and/or capable of treating or preventing a non-prostatic disorder.
Response to Arguments
Applicant's arguments filed on 6/11/2026 have been fully considered but they are not persuasive.
Applicant asserts “Bander does not teach that the binding agent may be J591 bound to the radioisotope 225Ac. Bander mentions that radioistopes that may be used include…. Radioisotopes useful as therapeutic agents include... Bander, however, never suggests the specific use of actinium (225Ac) from this list…” [Remarks, Page 10, Paragraph 1]
Applicant’s arguments are not persuasive because Bander does suggest the specific use of actinium (225Ac). See Bander [0145, 0163, 0171, 0324]. Moreover, 225Ac is listed twice in Applicant’s asserted list of radioisotopes that Bander discloses may be used.
Applicant asserts “nor does Bander suggest that an alpha emitter such as actinium (225Ac) can be used with any antibody, much less J591.” [Remarks, Page 10, Paragraph 1]
Applicant’s assertions are explicitly disproven by Bander. Bander states the following:
“For example, the modified anti-PSMA antibody… can be coupled to a radioactive isotope Such as an α-emitter.... Examples of radioactive isotopes include… actinium (225Ac)…” [0163]
“Monoclonal anti-PSMA antibodies can be used in the methods of the invention…. Examples of preferred murine monoclonal antibodies to human PSMA include, but are not limited to…J591…Most preferably, the murine monoclonal antibody is J591…” [0225]
Accordingly, Bander affirmatively states that an α-emitter, such as 225Ac, can be used with an antibody (an anti-PSMA antibody) and identifies J591 as a preferred anti-PSMA antibody.
Applicant asserts “Indeed, there is no specific example or embodiment in Bander disclosing that actinium (225 Ac) was used with J591. Thus, Bander does not teach or suggest J591 bound to the radioisotope 225 Ac, nor provide any guidance to one of ordinary skill in the art to make any selection from a specific list for administering a therapeutic dose for cancer, as claimed.” [Remarks, Page 10, Paragraph 1]
Applicant’s assertions are explicitly disproven by Bander. As explained above, Bander affirmatively states that an α-emitter such as actinium 225Ac, can be used with an antibody (an anti-PSMA antibody) and identifies J591 as a preferred anti-PSMA antibody. The teaching, suggestion, and guidance are provided by this contemplation. Moreover, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. MPEP 2123. The absence of a specific embodiment or example does not limit or negate Bander’s express disclosure.
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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