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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2025 has been entered.
The Amendment filed 11/14/2025, amended claim 51.
Claims 38, 40 and 43-51 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant elected without traverse, HuM195 (a/k/a lintuzumab) as the anti-CD33 targeting agent, Actinium-225 as the radiolabel species, and the combination of cladribine, cytarabine, mitoxantrone, and filgrastim as the chemotherapeutic agents, in the reply filed on 06/30/2022.
As evidenced by NIH, National Cancer Institute (PTO-892 of 08/11/2022), filgrastim and granulocyte colony-stimulating factor are synonyms (GCS) (instant claims 22-23).
It is noted that the instant claims are now limited to the elected species.
Claims 38, 40, and 43-51 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 U.S.C. § 112(d)
Applicant’s amendment to claim 51, that amends its dependency from claim 50 to claim 45, is sufficient to overcome this rejection.
REJECTIONS-Modified & New
The below prior art rejections have been modified by the addition of two prior art references. NCT02575963, US 2004/0152632 to Feingold, Wierzobowska, and Emens, continue to be relied upon as prior art references.
Claim Objections
(New) Claim 40 is objected to because of the following informalities: the claim is missing a period; each claim must begin with a capital letter and end with a period. See MPEP 608.01(m).
Appropriate correction is required.
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 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.
(Modified) Claims 38, 40, and 43-51 are rejected under 35 U.S.C. 103 as being unpatentable over NCT02575963 (“NCT ‘963”, History of Changes for Study: NCT02575963, Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients, published 10/07/2015, PTO-892 of 05/15/2025), in view of US 2004/0152632 to Feingold (published 2014, IDS of 6/15/2020), Wierzobowska (“Cladribine combined with high doses of arabinoside cytosine, mitoxantrone, and G-CSF (CLAG-M), and is a highly effective salvage regimen in patients with refractory and relapsed acute myeloid leukemia of the poor risk: a final report of the Polish Adult Leukemia Groups,” Eur. Jn. of Hematology, 2007, PTO-892 of 08/11/2022), Juric (Phase I Trial of the Targeted Alpha-Particle Nono-Generator Actinium-225 (225Ac)-Lintuzumab (Anti-CD33; HuM195) in Acute Myeloid Leukemia (AML, Blood, published 2011, PTO-892), O’Donoghue (Single-Dose Versus Fractionated Radioimmunotherapy : Model Comparisons for Uniform Tumor Dosimetry, The Jn of Nuclear Med, published 2000, PTO-892), and Emens (Chemoimmunotherapy, Cancer J, published 2010, PTO-892 of 08/11/2022), as evidenced by NIH G-CSF (PTO-892 of 08/11/2022).
NCT ‘963 teaches a method of treating acute myeloid leukemia (AML) by administering cytarabine and lintuzumab-Ac225 Cytarabine 20 mg every 12 hours on days 1 to 10 of each cycle, wherein the starting dose is 1.0 mCi/Kg lintuzumab-Ac225 (225Ac-labelled HuM195) and 15 mg/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given approximately 4-7 days after 1 cycle of low dose cytarabine and the second fraction given 4-7 days after the first fraction, followed by up to 11 more cycles. See pages 8-9, NCT ‘963.
NCT ‘963 teaches administration to patients 70 years old or older, meeting the limitation of a human subject.
Regarding claim 38, while NCT ‘963 teaches a method of treating AML in humans by administering, over a treatment period, a composition comprising a starting dose of 1.0 mCi/Kg lintuzumab-Ac225 (225Ac-labelled HuM195) and 15 mg/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given approximately 4-7 days after 1 cycle of low dose cytarabine, and the second fraction given 4-7 days after the first fraction, it differs from that of the instantly claimed invention in that it does not teach relapsed/refractory AML.
Feingold teaches methods of treating AML by administering an anti-CD33 cytotoxic conjugate in combination with at least one chemotherapeutic compound selected from an anthracycline, a pyrimidine, or a purine nucleoside analog (abstract; pgs. 11-12, claims 1, 17, 24), wherein HuM195 is an anti-CD33 targeting agent (see [0026] of the instant specification).
Feingold teaches its methods for the treatment of AML de novo treatment and AML relapse treatment ([0046]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select relapsed AML as the AML treated in NCT ‘963, to arrive at instant claim 38. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-NCT ‘963 and Feingold are both directed toward methods of treating AML by administering an anti-CD33 targeting agent and a chemotherapeutic, and
-Feingold teaches such methods for the treatment of de novo AML or relapsed AML.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at an effective method of treating relapsed AML. See also MPEP 2143(I)(E).
Further regarding claim 38, while the combination of Feingold and NCT ‘963 teaches a method of treating relapsed AML in humans by administering, over a treatment period, a composition comprising a starting dose is 1.0 mCi/Kg lintuzumab-Ac225 (225Ac-labelled HuM195) and 15 mg/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given approximately 4-7 days after 1 cycle of low dose cytarabine, and the second fraction given 4-7 days after the first fraction, it differs from that of the instantly claimed invention in that it does not teach the instantly claimed chemotherapeutic regimen.
Wierzobowska teaches that cladribine combined with high doses of arabinoside cytosine, which is cytarabine, mitoxantrone and G-CSF, (collectively referred to as CLAG-M) is a highly effective salvage regimen in patients with refractory and relapsed acute myeloid leukemia (title).
As evidenced by NIH, National Cancer Institute, filgrastim and granulocyte colony-stimulating factor are synonyms (G-CSF) (instant claims 22-23).
Wierzobowska teaches the following CLAG-M protocol:
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(p. 117).
CLAG-M salvage regimen is highly effective with a 58% complete remission rate and 4 year overall survival and disease-free survival (pg. 121). Additionally, the toxicity profile of CLAG-M regimen is acceptable, enabling most patients to receive further treatment including transplantation procedures (pgs. 122-23).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the cytarabine of the combination of NCT ‘963 and Feingold, with the CLAG-M of Wierzobowska, to arrive at instant claim 38. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Wierzobowska teaches CLAG-M as a highly effective salvage regimen with a 58% complete remission rate and 4 year overall survival and disease-free survival in AML patients(pg. 121),
-Wierzobowska teaches that the toxicity profile of CLAG-M regimen is acceptable, enabling most AML patients to receive further treatment including transplantation procedures, and
-simple substitution of one known element (chemotherapy regimen) for another to obtain predictable results is prima facie obvious (MPEP 2143(I)(B)).
As such, an artisan having ordinary skill in the art would have been motivated to make such a substitution to predictably arrive at a more effective method of treating relapsed AML.
Lastly regarding claim 38, while the combination of NCT ‘963, Feingold, and Wierzobowska teaches a method of treating relapsed AML in humans by administering, over a treatment period, a composition comprising a starting dose is 1.0 mCi/Kg lintuzumab-Ac225 (225Ac-labelled HuM195) and 15 mg/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given approximately 4-7 days after 1 cycle of
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, and the second fraction given 4-7 days after the first fraction, it differs from that of the instantly claimed invention in that it does not teach administration of a single dose on one of days 7, 8, or 9 of the treatment period.
Jurcic teaches single dose administration of lintuzumab-Ac225 in patients for the treatment of relapsed AML at doses of 0.5, 1, 2, 3, or 4 uCi/kg. Juric teaches that no acute toxicities were seen. (pgs. 1-2).
O’Donoghue teaches single-dose versus fractionated radioimmunotherapy model comparisons for uniform tumor dosimetry (title). Large single administrations and rapid fractionation of small individual administrations separated by time intervals were studied (abstract). O’Donoghue teaches that the single administration approach consistently produced smaller nadir values of tumor cell survival and tumor size, and that the predicted duration of remission was similar for both single administration and fractionation in macroscopic and microscopic tumors. O’Donoghue teaches that these findings are independent of tumor cell radiosensitivity, proliferation rate, rate of tumor shrinkage, and uptake characteristics of radiolabeled material in tumor. O’Donoghue concludes by stating that single administration using a short-range emitting radionuclide is most appropriate for therapy of microscopic diseases and that fractionation is most appropriate for macroscopic disease, and that there is rationale for combining single and fractionated treatment in which there is both macroscopic and microscopic disease (abstract).
Emens teaches that cancer therapy has evolved to strategically integrate distinct treatment modalities in order to optimize the chance of cure. Multiple drugs with complementary mechanisms of action and non-overlapping toxicities are frequently combined for additive or synergistic antitumor efficacy (pg. 1, Introduction). Emens further teaches that active immune-based approaches to cancer therapy will clearly add a new dimension to cancer care, but they are unlikely to replace traditional cancer therapies. Current data suggests that combination chemoimmunotherapy regimens have great potential for optimizing the clinical outcomes of cancer patients (pg. 2, last full paragraph).
Emens concludes by stating, “the potential for maximizing the bioactivity and clinical benefit of immune-based therapies has never been greater. Strategically integrating immunotherapies with chemotherapy drugs in order to shape the overall host milieu and the local tumor microenvironment and ameliorate distinct mechanisms of immune tolerance and suppression will ultimately support a vigorous and sustained antitumor immune response. Carefully dissecting the proper dose and timing of drugs for integrating with immune-based therapies in clinically relevant laboratory models and early phase clinical trials will accelerate late stage clinical development, making clinically meaningful chemoimmunotherapy for cancer care a reality,” (pg. 10).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the dosage administration of the lintuzumab-Ac225 (225Ac-labelled HuM195) and 15 mg/Kg unlabeled HuM195 in the combined method of NCT ‘963, Feingold, and Wierzobowska, to a single dose on days 7-9 of the treatment period, to arrive at instant claim 38. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Juric and NCT ‘963 are directed toward the treatment of relapsed AML with lintuzumab-Ac225, and Juric teaches administering lintuzumab-Ac225 in a single dose, wherein the single dose shows no toxicities,
-O’Donoghue teaches that both single and fractionated radioimmunotherapies are a) useful in different types of cancers, and b) show no difference in the duration of remission,
-Emens is directed toward combining immunotherapies with chemotherapies for the optimization of cancer treatment, and Emens teaches that the proper dose and timing of drugs results in clinically meaningful chemoimmunotherapy for cancer care, and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," see MPEP 2144.05(II).
As such, an artisan of ordinary skill would have been motivated to make such a modification, to predictably arrive at a dosage regimen that is optimized to most effectively treat relapsed AML with the least amount of side effects. Moreover, an ordinary skilled artisan would have predictably expected a single dose in comparison to a fractionated dose, to more potently treat/affect cancer cells.
Regarding claim 40, while the combination of NCT ‘963, Feingold, Wierzobowska, Juric, O’Donoghue, and Emens teaches a method of treating relapsed AML in humans by administering, over a treatment period, a composition comprising a dose of 1.0 mCi/Kg lintuzumab-Ac225 (225Ac-labelled HuM195) and 15 mg/Kg unlabeled HuM195 administered on days 7-9 of the treatment period, and
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, it differs from that of the instantly claimed invention in that it does not teach protein amounts.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select 0.01-1 mg/kg as the protein amount in the combined method of NCT ‘963, Feingold, Wierzobowska, Juric, O’Donoghue, and Emens, to arrive at instant claim 40. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-the combined method of NCT ‘963, Feingold, Wierzobowska, Juric, O’Donoghue, and Emens teaches the instantly claimed radiations doses and mg/m2 dosages, and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," see MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 43-45, Wierzobowska teaches the following CLAG-M protocol:
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(p. 117).
Regarding claims 43 and 45, the limitation "consisting essentially of" is interpreted no differently than "comprising,” since the instant specification provides no discussion or teaching of what limitations "materially affect the basic and novel characteristic(s)" of the claimed method, see MPEP 2111.03.
Regarding claims 46, 49 and 51, NCT ‘963 teaches a dose of 1.0 mCi/Kg lintuzumab-Ac225.
Regarding claims 47, 48, and 50, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claims 38, 40, and 43-51 are rendered obvious.
Response to Arguments
On pg. 5, Remarks, Applicant argues that “Rather than providing a reasoned explanation for the rejection, the Office simply states in a conclusory fashion that claims 28, 40, and 43-51 are obvious in in view of NCT ‘963, Feingold, Wierzobowska, and Emens.
This argument has been fully considered, but is not found persuasive. The rejection provides reasoned explanations for the combination of references:
1) It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select relapsed AML as the AML treated in NCT ‘963, to arrive at instant claim 38. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-NCT ‘963 and Feingold are both directed toward methods of treating AML by administering an anti-CD33 targeting agent and a chemotherapeutic, and
-Feingold teaches such methods for the treatment of de novo AML or relapsed AML.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at an effective method of treating relapsed AML. See also MPEP 2143(I)(E).
2) It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the cytarabine of NCT ‘963 with the CLAG-M of Wierzobowska, to arrive at instant claim 38. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Wierzobowska teaches CLAG-M as a highly effective salvage regimen with a 58% complete remission rate and 4 year overall survival and disease-free survival in AML patients(pg. 121),
-Wierzobowska teaches that the toxicity profile of CLAG-M regimen is acceptable, enabling most AML patients to receive further treatment including transplantation procedures, and
-simple substitution of one known element (chemotherapy regimen) for another to obtain predictable results is prima facie obvious (MPEP 2143(I)(B)).
As such, an artisan having ordinary skill in the art would have been motivated to make such a substitution to predictably arrive at a more effective method of treating relapsed AML.
3) It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the dosage administration of the lintuzumab-Ac225 (225Ac-labelled HuM195) and 15 mg/Kg unlabeled HuM195 in the combined method of NCT ‘963, Feingold, and Wierzobowska, to a single dose on days 7-9 of the treatment period, to arrive at instant claim 38. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Juric and NCT ‘963 are directed toward the treatment of relapsed AML with lintuzumab-Ac225, and Juric teaches administering lintuzumab-Ac225 in a single dose, wherein the single dose shows no toxicities,
-O’Donoghue teaches that both single and fractionated radioimmunotherapies are useful in different types of cancers, and show no difference in the duration of remission,
-Emens is directed toward combining immunotherapies with chemotherapies for the optimization of cancer treatment, and Emens teaches that the proper dose and timing of drugs results in clinically meaningful chemoimmunotherapy for cancer care, and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," see MPEP 2144.05(II).
As such, an artisan of ordinary skill would have been motivated to make such a modification, to predictably arrive at a dosage regimen that is optimized to most effectively treat AML with the least amount of negative side effects. Moreover, an ordinary skilled artisan would have predictably expected a single dose in comparison to a fractionated dose, to more potently treat/affect cancer cells.
As such, this argument is not persuasive to overcome the instant art rejection.
On pg. 5, Remarks, Applicant argues that Emens makes no mention of administering a single dose to the subject.
This argument has been fully considered. It is first pointed out that the above rejection has been modified. Emens is relied upon to teach that it is known in the art to modify the doses and dosage regimen of drugs in immune-chemotherapy, to arrive at the most optimized result; the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical science, and it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05. Moreover, Juric teaches the administration of a single dose of lintuzumab, and O’Donoghue teaches that it is known in the art to administer single or fractionated dosages of radioimmunotherapies.
Regarding the arguments toward Emens on pgs. 6-7, Remarks, it is respectfully pointed out that the above rejection has been modified to include the teachings of Juric and O’Donoghue which further provide a teaching of single dose administration and motivation to modify the fractionated dosing of NCT ‘963 to single dose administration.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the dosage administration of the lintuzumab-Ac225 (225Ac-labelled HuM195) and 15 mg/Kg unlabeled HuM195 in the combined method of NCT ‘963, Feingold, and Wierzobowska, to a single dose on days 7-9 of the treatment period, to arrive at instant claim 38. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Juric and NCT ‘963 are directed toward the treatment of relapsed AML with lintuzumab-Ac225, and Juric teaches administering lintuzumab-Ac225 in a single dose, wherein the single dose shows no toxicities,
-O’Donoghue teaches that both single and fractionated radioimmunotherapies are useful in different types of cancers, and show no difference in the duration of remission,
-Emens is directed toward combining immunotherapies with chemotherapies for the optimization of cancer treatment, and Emens teaches that the proper dose and timing of drugs results in clinically meaningful chemoimmunotherapy for cancer care, and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," see MPEP 2144.05(II).
As such, an artisan of ordinary skill would have been motivated to make such a modification, to predictably arrive at a dosage regimen that is optimized to most effectively treat AML with the least amount of negative side effects. Moreover, an ordinary skilled artisan would have predictably expected a single dose in comparison to a fractionated dose, to more potently treat/affect cancer cells.
On pgs. 7-9, Remarks, Applicant argues that unexpected results have been achieved, stating that “the combination of acitimab-A and CLAG-M produced high response rates with deep remissions including high rates of MRD negativity, improving access to potentially curable BMT resulting in enhanced survival outcomes.” Applicant provides the “Discussion” section of a publication that appears to evaluate the effectiveness of lintuzumab-Ac225 in combination with CLAG-M.
Regarding the “Discussion,” it is respectfully pointed out that no data or details regarding the study are provided. The “Discussion” is not commensurate in scope with the instant claims for the following reasons:
-The “Discussion” is directed toward a composition comprising 225Ac-labeled HuM195, however the instant claims are directed toward a composition comprising 225Ac-labeled HuM195 and unlabeled HuM195.
-The “Discussion” does not specify a) a radiation dose of the 225Ac-HuM195 and un-labelled HuM195, b) whether the radiation dose is administered as a single or fractionated dose, or c) on what days the dose is administered, however the instant claims recite the composition as comprising a radiation dose of 0.7-1.5uCi/kg, and administered in a single dose on days 7, 8, or 9 of treatment.
-The discussion does not specify the individual mg amounts of the CLAG-M components or the days on which the individual CLAG-M components are administering, however the instant claims recite specific mg amounts of cladribine, cytarabine, mitoxantrone, and filgrastim, and the days on which it they are administered.
As such, the “Discussion” is not commensurate in scope with the instant claims, and is therefore not persuasive to show unexpected results. Moreover, the “Discussion” does not provide a comparison with the closest prior art. While, the discussion does discuss how lintuzumab-Ac225, provides a potential advantage over gemtuzumab ozogamicin (GO) because drug internalization and DNA binding is not required, GO is not the closest prior art. As described above, the prior art teaches the administration of lintuzumab-Ac225 and un-labeled lintuzumab in combination with chemotherapy for the treatment of AML, which appears to be the closest prior art.
Regarding the arguments on pgs. 10-11, see the above modified prior art rejection, which specifically teaches single dose administration and which provides motivation to modify the dosage regimen of NCT ‘963 to arrive at a single dose administration.
For these reasons, the instant arguments are not persuasive to overcome the rejection of record.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622