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 III 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Claims 1, 3-11, 13-15, 17-19, and 21-22 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I and II, and there being no allowable generic or linking claim.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, 13
Withdrawn: 1, 3-11, 13-15, 17-19, and 21-22
New: 27-41
Examined Herein: 24, 26-41
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in PRO 62 153,132 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 16/653,655.
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.
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 608.01(m)
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29 and 30 rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention.
Claim 29 recites the limitation “if the patient has as an increase in PSA of at least 25% PSA from nadir (at least 5 ng/mL).” It is unclear why “(at least 5 ng/mL)” is in parentheses and how this language limits the claim, if at all. Further clarification is requested. Moreover, claim 29 recites the limitation “radiographic progression (1 new bone scan lesion.” This limitation contains mismatched parenthesis and it is unclear what information is intended to be within the parenthesis and how this language limits the claim, if at all. Correction and/or further clarification is requested. Dependent claim 30 falls therewith.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 24, 26-34 and 39-41 are rejected under pre-AIA 35 U.S.C. 102(a) and 102(b) as being anticipated by 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, 111In-DOTA-deJ591, to a patient; [0522, 0530]
detecting a presence of the labeled first binding agent in a bodily fluid in a patient; [0522, 0530]
wherein the labeled first binding agent is capable of binding a domain of Prostate Specific Membrane Antigen (PSMA); [0014]
wherein the presence of the labeled first binding agent is indicative of cancer; [0409, 0521]
wherein the patient is selected for an administration of a therapeutic dose of a second binding agent, 90Y-DOTA-deJ591, and the labeled first binding agent is detected; [0522, 0530]
and wherein the second binding agent is capable of binding a domain of PSMA, thus meeting the limitations of claim 24. [0014]
With respect to claim 26, Bander discloses the labeled first and second binding agents targets are substantially the same epitope of the extracellular domain of PSMA, thus meeting the limitations of claim 26. [0014]
With respect to claim 31-34, Bander discloses the second binding agent is a radiolabeled anti-PSMA antibody, 90Y-DOTA-deJ591, thus meeting the limitations of claim 31, 32, 33, and 34. [0522, 0530]
With respect to claim 39-41, Bander discloses the cancer is prostate cancer, thus meeting the limitations of claim 39, 40, and 41. [0522]
Also, with respect to claim 24, Bander discloses a method for treating cancer comprising:
administering a labeled first binding agent, 177Lu-DOTA-deJ591, to a patient; [0555]
detecting a presence of the labeled first binding agent in a tissue in a patient; [0560]
wherein the labeled first binding agent is capable of binding a domain of Prostate Specific Membrane Antigen (PSMA); [0014]
wherein the presence of the labeled first binding agent is indicative of cancer; [0409, 0521]
wherein the patient is selected for an administration of a therapeutic dose of a second binding agent, 177Lu-DOTA-deJ591, and the labeled first binding agent is detected; [0552, 0555]
and wherein the second binding agent is capable of binding a domain of PSMA, thus meeting the limitations of claim 24. [0014]
With respect to claim 27, Bander discloses the labeled first and second binding agents targets are substantially the same epitope of the extracellular domain of PSMA, thus meeting the limitations of claim 27. [0014]
With respect to claim 28, Bander discloses the patient is visually scored 2 weeks after the dose the labeled first binding agent, thus meeting the limitations of claim 28. [0560]
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, thus meeting the limitations of claim 29. [0555, 0567, 0585, 0586]
With respect to claim 30, Bander discloses the labeled first binding agent, 177Lu-DOTA-deJ591, is an anti-PSMA antibody, thus meeting the limitations of claim 30. [0552, 0555]
With respect to claim 31, Bander discloses the second binding agent is a radiolabeled anti-PSMA antibody, 177Lu-DOTA-deJ591, thus meeting the limitations of claim 31, 32, 33, and 34. [0552, 0555]
With respect to claim 39-41, Bander discloses the cancer is prostate cancer, thus meeting the limitations of claim 39, 40, and 41. [0552].
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 and 26-41 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bander, as applied to claim 24, 26-34 and 39-41 above.
With respect to claim 24, Bander discloses the teachings above.
Bander does not explicitly disclose the second binding agent is 225Ac-J591 or the patient is given an additional therapeutic agent.
However, with respect to claim 35, Bander discloses the anti-PSMA antibody, J591, may be coupled to a radioactive isotope such as 90Y, 177Lu, or 225Ac. [0163]
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 radioactive isotope, 177Lu or 90Y, of the second binding agent, with 225Ac to form 225Ac-DOTA-deJ591, results in the method of claim 35.
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 Bander by replacing the radioactive isotope, 177Lu or 90Y, of the second binding agent, with 225Ac to form 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, which is an anti-PSMA antibody, J591, coupled to a radioactive isotope, 90Y or 177Lu. Bander further discloses the anti-PSMA antibody may be coupled to a radioactive isotope such as 90Y, 177Lu, or 225Ac. So, Bander discloses the second binding agent is an anti-PSMA antibody coupled to a radioactive isotope, and further discloses 225Ac is a suitable radioactive isotope for said coupling. Thus, the teachings of Bander suggest that 225Ac may be the radioactive isotope coupled to DOTA-deJ591 in the second binding agent. Therefore, it is reasonable to expect the methods disclosed by Bander may be modified by replacing the radioactive isotope, 177Lu or 90Y, of the second binding agent, with 225Ac to form 225Ac-DOTA-deJ591. One would have been motivated to do so because the selection of a known material based on its suitability for its intended use is prima facie obvious. In the instant case, Bander discloses the anti-PSMA antibody may be coupled to a radioactive isotope including 90Y, 177Lu, or 225Ac. Therefore, the selection of 225Ac based on its suitability as a radioactive isotope for its intended use of being coupled to the anti-PSMA antibody in the second binding agent is prima facie obvious.
It would be obvious to one of ordinary skill in the art to modify 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 and have a reasonable expectation of success. Bander discloses a method comprising administering a therapeutic agent, [177Lu or 90Y]-DOTA-deJ591, which comprises an anti-PSMA antibody. Bander further discloses the anti-PSMA antibody may be administered in combination with a cytotoxic agent. Thus, the teachings of Bander suggest that a cytotoxic agent may be administered in combination with the therapeutic agent, [177Lu or 90Y]-DOTA-deJ591 comprising an anti-PSMA antibody. Therefore, it is reasonable to expect the methods disclosed by Bander may be modified 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. One would have been motivated to do so because Bander 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]
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 a maytansinoid, taxol, or taxotere, and have a reasonable expectation of success. Bander discloses a method comprising administering a therapeutic agent, [177Lu or 90Y]-DOTA-deJ591, which comprises an anti-PSMA antibody. Bander further discloses the anti-PSMA antibody may be administered in combination with maytansinoid, taxol, or taxotere. Thus, the teachings of Bander suggest that a maytansinoid, taxol, or taxotere may be administered in combination with the therapeutic agent, [177Lu or 90Y]-DOTA-deJ591, comprising an anti-PSMA antibody. Therefore, it is reasonable to expect the methods disclosed by Bander may be modified by administering an additional therapeutic agent including maytansinoid, taxol, or taxotere. One would have been motivated to do so because Bander discloses combining the anti-PSMA antibody with an additional therapeutic agent makes treatment more effective. [0402]
Conclusion
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/K.A.C./ Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618