DETAILED ACTION
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 .
Claims 1-10, submitted on 12 October 2023, are subject to a restriction requirement.
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 (i.e., changing from AIA to pre-AIA ) 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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 16 April 2021.
Information Disclosure Statement
Three Information Disclosure Statements (IDSs), submitted 12 October 2023, 31 December 2024, and 21 November 2025, are acknowledged and have been considered.
Claim Objections
Claim 5 is objected to because of the following informalities: The claim states “patient suffered from”. The Examiner believes this should read “patient suffers from”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: The word “further” is misspelled as “furthter” . Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter—namely, machine, manufacture, composition of matter, and process claims. The claims are directed towards the use of mitoxantrone hydrochloride liposome. As such, the claims are not directed to a process, machine, manufacture, or composition of matter (See MPEP § 2173.05(q)).
Claim Rejections - 35 USC § 112(b)
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 1-4 and 10 are rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The “use” limitations of Claims 1-4 and 10 render the metes and bounds of the claims undefined (hence rendering the claims indefinite) since there are no active gerund (“-ing”) ending verbs actually setting out each step required in a method claim. There is confusion as to whether the claims are intended to be method claims, given that “use” claims are non-statutory in nature (see 35 U.S.C. § 101 rejection, above) (See MPEP § 2173.05(q)).
Claims 1, 2, 3, 7, and 9 rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims have the limitation of “urothelial carcinoma, breast cancer, bone, and soft tissue sarcoma” or “bone and soft tissue sarcoma”. It is unclear if the method/liposome which is claimed is treating a patient with each form of cancer at once (all of urothelial carcinoma, breast cancer, bone and soft tissue sarcoma), or if the patient only needs one form of cancer for these claims (urothelial carcinoma, breast cancer, bone or soft tissue sarcoma).
Claims 3-10 are rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims are indefinite due to the inclusion of “preferably” and “more preferably”, causing it to be unclear if the limitations which follow are required parts of the invention, or merely preferred embodiments.
Claim 4 is rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 4 has the limitation of “including liquid injection, powder for injection, tablet for injection”. It is unclear if the limitations which follow “including” are necessary parts of the invention, or are preferred embodiments.
Claim 4 rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 4 has the limitation of “including liquid injection, powder for injection, tablet for injection, etc;”. It is unclear what other forms of injection are encompassed by “etc.”, causing the metes and bounds of the claim to be undefined.
Claim 10 is rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The phrases "such as" and “e.g.” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 is rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 10 has limitations which contain “about” in reference to their values. “About” is not defined within the claim or specification, causing the metes and bounds to be indefinite as it is unknown what encompasses “about”.
Claim 10 is rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 10 recites the limitation "the method of according to claim 1" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as Claim 1 does not reference or define a method.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mei (US 2020/0197534; Publication Date: 25 June 2020).
Mei (See IDS, 12 October 2023) discloses methods and compositions where an inducer of cell death (ICD-inducer)-inducing agent (e.g., doxorubicin, oxaliplatin, mitoxantrone etc.) and an IDO pathway inhibitor are integrated into a nanocarrier that allows systemic delivery (Abstract). It is believed that a mitoxantrone (MTX) encapsulated nanocarrier provides a more potent ICD stimulus than the free drug (Paragraph 0011). It is noted that the use of both mitoxantrone-only and mitoxantrone-IND liposomes were extremely effective in a 4T1 breast cancer model (See, e.g., Example 8), and much better than the results with a Doxil equivalent liposome delivering doxorubicin only. In the 4T1 model, the mitoxantrone-only liposome was so effective that an additional effect for cholesterol-IND was not observed, reflecting the possibility that the 4T1 triple negative breast cancer model may represent a TN cancer subset in which IDO-1 does not play a major role (Paragraph 0456). In certain embodiments, the use of liposomes containing mitoxantrone where the lipid bilayer does not contain IND or other IDO inhibitor. In certain embodiments the liposome formulations are the same as liposome formulations described herein comprising IND, but the lipid bilayer components do not comprise a conjugated IDO inhibitor (Paragraph 0460).
Claims 6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nikoulin (WO 2018/048752; Publication Date: 15 March 2018).
Nikoulin (See IDS, 31 December 2024) discloses methods and compositions for the treatment of cancer. Compositions are liposome encapsulated chemotherapeutic agents, encompassing a weakly basic anticancer agent (Abstract). In embodiments, the weakly basic anticancer compound is mitoxantrone (Paragraph 0009). In aspects, the disclosure provides a method of treating a cancer in a subject (Paragraph 0022). Example 12 (Page 112) demonstrates the preparation of mitoxantrone hydrochloride liposomes. The target particle size was 60-70 nm (Paragraphs 0396, 0401). Embodiment 117 discloses a method of treating cancer in a subject comprising administering a pharmaceutical composition comprising a liposome of the invention to a subject in need of treatment (Paragraph 0541). “Administering” refers to the physical introduction of a composition to a subject. Routes of administration for the composition described herein include intravenous (Paragraph 0103). Exemplary cancers which can be treated with a composition or method disclosed herein include sarcoma, bladder cancer, bone cancer, prostate cancer, breast cancer, rhabdomyosarcoma, urinary bladder cancer, testicular cancer, and genitourinary tract cancer (Paragraph 0107).
Claims 6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pestalozzi (Annals of Oncology, 1992, 445-495).
Pestalozzi (See IDS, 21 November 2025) discloses the administration of liposome-complexed mitoxantrone to patients with breast cancer. These liposomes were given as IV infusion every 3 weeks, starting dose was 3 mg/m2, and the dose was increased at each cycle by 3 mg/m2 up to 12 mg/m2 (Abstract, page 446, right hand column).
Claims 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (US 2016/0235671; Publication Date: 18 August 2016).
Li discloses a liposomal pharmaceutical preparation containing a multivalent ionic drug and use thereof in the treatment of diseases, in which the liposome has a size of about 30-80 nm, and the phospholipid bilayer has a phospholipid with a Tm higher than body temperature, so that the phase transition temperature of the liposome is higher than the body temperature (Abstract). Example 3 (Paragraph 0052) discloses mitoxantrone hydrochloride liposomes. Example 18 (Paragraph 0071) demonstrates use of these liposomes in the treatment of a mouse model of soft tissue sarcoma (S180 tumor cells). The mice were administered via IV injection (Paragraph 0072).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mei (US 2020/0197534; Publication Date: 25 June 2020) in view of Chiang (The Kaohsiung Journal of Medical Sciences, 1 Feb 2000, 16(2):91-94), Dietel (J Cancer Res Clin Oncol, 1988, 114: 197-203), and Park (Oncol Lett., 2018 April 20, 15(6):9687-9696).
The teachings of Mei are previously described and are fully incorporated into this rejection.
Mei fails to teach the use of mitoxantrone liposomes for the treatment of urothelial carcinoma, soft tissue sarcoma, or bone sarcoma.
Chiang studied the use of mitoxantrone in the treatment of transitional cell carcinoma of the bladder (urothelial carcinoma). 25 patients with transitional cell carcinoma of the bladder were treated by transurethral resection followed by intravesical chemoprophylaxis with mitoxantrone. After 12 months, 76% of patients in the whole group, 69% in the newly diagnosed patients, and 90% in the group of previously relapsed patients remained relapse free. The results indicate that mitoxantrone is an effective and safe agent for intravesical chemotherapy (Abstract).
Dietel investigated the use of mitoxantrone in vitro in 6 sarcomatous human cell lines derived from 2 synovial sarcomas, a malignant schwannoma, a malignant histiocytoma, a leiomyosarcoma, and a chondrosarcoma. Mitoxantrone inhibited the proliferation rate of 4 sarcomatous tumor cell lines more intensely than adriamycin, and was less effective in 2 cell lines. However, these differences were not significant. In all mesenchymal cell lines tested the antiproliferative potency of MITOX was more pronounced than cisplatin. The study suggests that mitoxantrone possesses a growth inhibitory potency for malignant soft tumors in vitro (Abstract).
Park screened small chemicals which activate FOXO3 and elucidate their underlying mechanism. Mitoxantrone was selected as a possible FOXO3 activator. Mitoxantrone treatment significantly inhibited the phosphorylation of Akt-pS473 and caused nuclear localization of FOXO3 in osteosarcoma cells. Mitoxantrone treatment inhibited proliferation of osteosarcoma cells in vitro, whereas silencing FOXO3 potently attenuates mitoxantrone-mediated apoptosis in osteosarcoma cells. These results indicate that mitoxantrone induces apoptosis in osteosarcoma cells through an Akt/FOXO3-dependent mechanism (Abstract).
Mei, Chiang, Dietel, and Park are considered analogous to the claimed invention as all utilize mitoxantrone for the treatment of various forms of cancer. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to apply the mitoxantrone liposomes of Mei for the treatment of urothelial carcinoma, soft tissue sarcoma, or bone sarcoma as Chang, Dietal, and Park each demonstrate that unformulated mitoxantrone is effective in inhibiting the growth and proliferation of each of these forms of cancer, providing a motivation and reasonable expectation of success to apply the liposomes of Mei for the treatment of these specific cancers. The application of the liposomes of Mei for the treatment of these cancers is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I(A)). Mei demonstrates that mitoxantrone liposomes are useful for the treatment of different forms of cancer, with Chiang, Dietel, and Park each demonstrating that mitoxantrone is effective in inhibiting the growth of the claimed cancers. The artisan would recognize that mitoxantrone is useful for the treatment of these cancers, and be motivated to apply the liposomes of Mei as liposomal formulations are used to improve pharmacokinetics of chemotherapeutics, and to reduce off-target effects.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nikoulin (WO 2018/048752; Publication Date: 15 March 2018) in view of Chiang (The Kaohsiung Journal of Medical Sciences, 1 Feb 2000, 16(2):91-94), Dietel (J Cancer Res Clin Oncol, 1988, 114: 197-203), and Park (Oncol Lett., 2018 April 20, 15(6):9687-9696).
The teachings of Nikoulin are previously described and are fully incorporated into this rejection.
Nikoulin fails to teach the use of mitoxantrone liposomes for the treatment of urothelial carcinoma, soft tissue sarcoma, or bone sarcoma.
The teachings of Chiang, Dietel, and Park are previously described and are fully incorporated into this rejection.
Nikoulin, Chiang, Dietel, and Park are considered analogous to the claimed invention as all utilize mitoxantrone for the treatment of various forms of cancer. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to apply the mitoxantrone liposomes of Nikoulin for the treatment of urothelial carcinoma, soft tissue sarcoma, or bone sarcoma as Chang, Dietal, and Park each demonstrate that unformulated mitoxantrone is effective in inhibiting the growth and proliferation of each of these forms of cancer, providing a motivation and reasonable expectation of success to apply the liposomes of Nikoulin for the treatment of these specific cancers. The application of the liposomes of Nikoulin for the treatment of these cancers is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I(A)). Nikoulin demonstrates that mitoxantrone liposomes are useful for the treatment of different forms of cancer, with Chiang, Dietel, and Park each demonstrating that mitoxantrone is effective in inhibiting the growth of the claimed cancers. The artisan would recognize that mitoxantrone is useful for the treatment of these cancers, and be motivated to apply the liposomes of Nikoulin as liposomal formulations are used to improve pharmacokinetics of chemotherapeutics, and to reduce off-target effects.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Pestalozzi (Annals of Oncology, 1992, 445-495) in view of Chiang (The Kaohsiung Journal of Medical Sciences, 1 Feb 2000, 16(2):91-94), Dietel (J Cancer Res Clin Oncol, 1988, 114: 197-203), and Park (Oncol Lett., 2018 April 20, 15(6):9687-9696).
The teachings of Pestalozzi are previously described and are fully incorporated into this rejection.
Pestalozzi fails to teach the use of mitoxantrone liposomes for the treatment of urothelial carcinoma, soft tissue sarcoma, or bone sarcoma.
The teachings of Chiang, Dietel, and Park are previously described and are fully incorporated into this rejection.
Pestalozzi, Chiang, Dietel, and Park are considered analogous to the claimed invention as all utilize mitoxantrone for the treatment of various forms of cancer. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to apply the mitoxantrone liposomes of Pestalozzi for the treatment of urothelial carcinoma, soft tissue sarcoma, or bone sarcoma as Chang, Dietal, and Park each demonstrate that unformulated mitoxantrone is effective in inhibiting the growth and proliferation of each of these forms of cancer, providing a motivation and reasonable expectation of success to apply the liposomes of Pestalozzi for the treatment of these specific cancers. The application of the liposomes of Pestalozzi for the treatment of these cancers is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I(A)). Pestalozzi demonstrates that mitoxantrone liposomes are useful for the treatment of breast cancer, with Chiang, Dietel, and Park each demonstrating that mitoxantrone is effective in inhibiting the growth of the claimed cancers. The artisan would recognize that mitoxantrone is useful for the treatment of these cancers, and be motivated to apply the liposomes of Pestalozzi as liposomal formulations are used to improve pharmacokinetics of chemotherapeutics, and to reduce off-target effects.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2016/0235671; Publication Date: 18 August 2016) in view of Pestalozzi (Annals of Oncology, 1992, 445-495), Chiang (The Kaohsiung Journal of Medical Sciences, 1 Feb 2000, 16(2):91-94) and Park (Oncol Lett., 2018 April 20, 15(6):9687-9696).
The teachings of Li are previously described and are fully incorporated into this rejection.
Li fails to teach the use of mitoxantrone liposomes for the treatment of urothelial carcinoma, breast cancer, or bone sarcoma.
The teachings of Pestalozzi, Chiang, and Park are previously described and are fully incorporated into this rejection.
Li, Chiang, Pestalozzi, and Park are considered analogous to the claimed invention as all utilize mitoxantrone for the treatment of various forms of cancer. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to apply the mitoxantrone liposomes of Li for the treatment of urothelial carcinoma, breast cancer, or bone sarcoma as Chang, Pestalozzi, and Park each demonstrate that mitoxantrone is effective in inhibiting the growth and proliferation of each of these forms of cancer, providing a motivation and reasonable expectation of success to apply the liposomes of Li for the treatment of these specific cancers. The application of the liposomes of Li for the treatment of these cancers is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I(A)). Li demonstrates that mitoxantrone liposomes are useful for the treatment of soft tissue sarcoma, with Chiang, Pestalozzi, and Park each demonstrating that mitoxantrone is effective in inhibiting the growth of the claimed cancers. The artisan would recognize that mitoxantrone is useful for the treatment of these cancers, and be motivated to apply the liposomes of Li as liposomal formulations are used to improve pharmacokinetics of chemotherapeutics, and to reduce off-target effects.
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 7 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,028,913 (Patent Date: 24 July 2018) (‘913).
Claim 1 of ‘913 is directed to a method for treating sarcoma, comprising administering to a patient need thereof, liposomes, wherein the liposomes encapsulate mitoxantrone and have a mean size of 35-75 nm, and
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. The claims are not identical but are not patentably distinct because Claim 1 of ‘913 is directed towards a method of treating sarcoma with mitoxantrone liposomes, while the claims at issue are related to the specific treatmetn of soft tissue or bone sarcomas. These are forms of sarcoma, and it would be obvious to use these liposomes to treat these two forms of sarcoma. Claim 1 of ‘913 also discloses mitoxantrone liposomes, meeting the limitations of Claim 9 as claim 9 is written with intended use language.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,583,508 (Patent Date: 21 February 2023) (‘508).
Claim 1 of ‘508 is directed to a method for treating sarcoma, comprising administering to a patient need thereof, liposomes, wherein the liposomes encapsulate mitoxantrone and have a mean size of 35-75 nm, and
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. The claims are not identical but are not patentably distinct because Claim 1 of ‘508 discloses mitoxantrone liposomes, meeting the limitations of Claim 9 as claim 9 is written with intended use language.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,357,728 (Patent Date: 14 June 2022) (‘728).
Claim 6 of ‘728 is directed to a liposome comprising bilayer and inner water phase, wherein the inner water phase comprises sulfobutyl ether cyclodextrin, one or more active compounds selected from the group consisting of doxorubicin, epirubicin, pirarubicin, idarubicin, and mitoxantrone, and one or more of ammonium hydroxide, triethylamine, and triethanoloamine, wherein the sulfobutyl ether cyclodextrin forms precipitate with the active compound in the inner water phase. The claims are not identical but are not patentably distinct because Claim 6 of ‘728 discloses mitoxantrone liposomes, meeting the limitations of Claim 9 as claim 9 is written with intended use language.
Claims 6 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending Application No. 17/760,240 (Amended Claims of 17 December 2025) (‘240) (reference application).
Claim 7 of ‘240 is directed to a method of treating breast cancer comprising administering to a patient with breast cancer a therapeutically effective amount of a mitoxantrone hydrochloride liposome alone wherein the breast cancer is advanced recurrent or metastatic breast cancer that is unsuitable for or tolerant to endocrine therapy, HER2 negative or refractory to HER2 targeted therapy. This claim meets limitations of Claim 9 as the reference application discloses mitoxantrone liposomes, and claim 9 of the examined application is written with intended use language.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending Application No. 18/020,089 (Amended Claims of 4 December 2025) (‘089) (reference application).
Claim 7 of ‘089 is directed to a method for treating NK/T-cell lymphoma, wherein: therapeutically effective amounts of mitoxantrone hydrochloride liposome and pegaspargase are administered to a patient with NK/T-cell lymphoma, and the administration is injection form; calculated on the basis of mitoxantrone, the therapeutically effective amount of mitoxantrone hydrochloride liposome is 8 to 30 mg/m2, and an administration cycle of the mitoxantrone hydrochloride liposome is once every 3 weeks. This claim meets limitations of Claim 9 as the reference application discloses mitoxantrone liposomes, and claim 9 of the examined application is written with intended use language.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of copending Application No. 18/023,161 (Amended Claims of 20 October 2025) (‘161) (reference application).
Claim 1 of ‘161 is directed to a method of treating treatment-naïve peripheral T-cell lymphoma comprising administering a therapeutically effective dose of a mitoxantrone liposome, cyclophosphamide, vincristine, and prednisone to a treatment-naïve PTCL patient in need thereof, wherein the mitoxantrone liposome is a mitoxantrone hydrochloride liposome, and the therapeutically effective dose of the liposome is 18 to 30 mg/m2 in terms of mitoxantrone. Claim 11 of ‘161 claims the method of claim 1 wherein the liposome has a particle size of 30 to 80 nm and contains: 1)mitoxantrone hydrochloride as an active ingredient, and 2) a lipid bilayer containing a lipid, wherein the lipid is phosphatidylcholine, hydrogenated soybean phosphatidylcholine, hydrogenated egg-yolk phosphatidylcholine, dipalmitoyl phosphatidylcholine, or distearoyl phosphatidylcholine or any combination thereof. These claims meet limitations of Claim 9 as the reference application discloses mitoxantrone liposomes, and claim 9 of the examined application is written with intended use language.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34 and 36 of copending Application No. 18/266,870 (Claims of 13 June 2023) (‘870) (reference application).
Claim 34 of ‘870 claims a method of treating ovarian cancer, gastric cancer, or head and neck squamous cell carcinoma in a subject comprising administering a therapeutically effective amount of a mitoxantrone hydrochloride liposome. Claim 36 of ‘870 claims the method of claim 34 wherein the liposome has one or more of the following properties:
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. These claims meet limitations of Claim 9 as the reference application discloses mitoxantrone liposomes, and claim 9 of the examined application is written with intended use language.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of copending Application No. 18/996,594 (Claims of 17 January 2025) (‘594) (reference application).
Claim 12 of ‘594 claims a method for treating neuromyelitis optica spectrum disorders in an individual comprising administering a therapeutically effective amount of mitoxantrone hydrochloride liposome. This claim meets limitations of Claim 9 as the reference application discloses mitoxantrone liposomes, and claim 9 of the examined application is written with intended use language.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22 and 25 of copending Application No. 19/107,103 (Claims of 27 February 2025) (‘103) (reference application).
Claim 22 of ‘103 claims a method of treatment of nasopharyngeal carcinoma, comprising administering to a patient a therapeutically effective amount of a mitoxantrone liposome and capecitabine. Claim 25 of ‘103 claims the method of claim 22 wherein the liposome has one or more of the following properties:
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. These claims meet limitations of Claim 9 as the reference application discloses mitoxantrone liposomes, and claim 9 of the examined application is written with intended use language.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending Application No. 18/564,796 (Amended Claims of 19 December 2025) (‘796) (reference application).
Claim 7 of ‘796 claims a method of treatment of advanced solid tumor, comprising the following steps: administering to a patient having the advanced solid tumor a therapeutically effective amount of a mitoxantrone hydrochloride liposome, wherein advanced solid tumors are advanced ovarian cancer or fallopian tube cancer wherein the therapeutically effective amount of mitoxantrone hydrochloride liposome is of 24-40 mg/m2;
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. This claim meets limitations of Claim 9 as the reference application discloses mitoxantrone liposomes, and claim 9 of the examined application is written with intended use language.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-10 are rejected.
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/P.M.R./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625