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 .
Status
Pursuant to preliminary amendments filed 13 June 2023, claims 34-53 are pending in the application.
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 36-40 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 term “poorly soluble” in claims 36 and 40 is a relative term which renders the claim indefinite. The term “poorly soluble” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to what extent the precipitate must be soluble to be poorly soluble, rendering the claim indefinite. Claims 37-39 are rejected as depending upon claim 36 without remedying such deficiency.
Claim 40 recites the limitation "the medicament" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 34-35 and 42-53 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ahmad et al. (US 2003/0219476 A1; published 27 November 2003).
Regarding claim 34, Ahmad et al. discloses a method of treating a mammalian disease comprising: administering to a mammal a pharmaceutical composition comprising a therapeutically effective amount of mitoxantrone in a liposomal formulation (claim 1) wherein the mammal is human (claim 2) wherein disease in particular is ovarian cancer (paragraph [0031]) wherein the mitoxantrone is mitoxantrone hydrochloride (paragraph [0002]; Example 6), which reads on the claimed method of treating ovarian cancer, gastric cancer, or head and neck squamous carcinoma in a subject, comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of mitoxantrone hydrochloride liposome.
Regarding claim 35, claim 1 of Ahmad et al. lists no other active ingredient (claim 1), which reads on the claimed mitoxantrone hydrochloride liposome being the only active ingredient in the pharmaceutical composition.
Regarding claim 42, the claimed recitation of the gastric cancer being advanced merely further limits the gastric cancer recited in claim 34, but such gastric cancer remains optional and is not required per claims 34 and 42.
Regarding claim 43, the claimed recitation of the head and neck squamous cell carcinoma being a listed type merely further limits the head and neck squamous cell carcinoma recited in claim 34, but such head and neck squamous cell carcinoma remains optional and is not required per claims 34 and 43.
Regarding claim 44, the claimed recitation of the head and neck squamous cell carcinoma being a listed type merely further limits the head and neck squamous cell carcinoma recited in claim 34, but such head and neck squamous cell carcinoma remains optional and is not required per claims 34 and 44.
Regarding claim 45, the claimed recitation of the first line therapy being a listed type merely further limits the first line therapy recited in claim 44, but such first line therapy remains optional and is not required per claims 34 and 44-45.
Regarding claim 46, the composition is injected (Examples 8-12, 14, 16, 18), which reads on the claimed pharmaceutical composition being in the form of an injection.
Regarding claim 47, the composition is a solution (paragraph [0028]; Examples 6-7) and is injected (Examples 8-12, 14, 16, 18), which reads on the claimed pharmaceutical composition being in the form of a liquid injection.
Regarding claim 48, the composition is a solution (paragraph [0028]; Examples 6-7) and is injected (Examples 8-12, 14, 16, 18) and has a 1 mg/mL mitoxantrone concentration (Example 7), which reads on the claimed pharmaceutical composition being in the form of a liquid injection with 0.5-5 mg/mL mitoxantrone.
Regarding claim 49, the composition is a solution (paragraph [0028]; Examples 6-7) and is injected (Examples 8-12, 14, 16, 18) and has a 1 mg/mL mitoxantrone concentration (Example 7), which reads on the claimed pharmaceutical composition being in the form of a liquid injection with 1-2 mg/mL mitoxantrone.
Regarding claim 50, intravenous administration is preferred (paragraph [0032]) and injections were via i.v. (Examples 8-14 and 16-19), which reads on the claimed administration by intravenous administration.
Regarding claim 51, intravenous administration is preferred (paragraph [0032]) and injections were via i.v. (Examples 8-14 and 16-19), and the dosage form is dispensed by infusion over 45 minutes (paragraph [0024]), which reads on the claimed infusion intravenous administration time of 30-120 minutes.
Regarding claim 52, patients are treated with i.v. administration of liposomal mitoxantrone every three weeks (Example 19), which reads on the claimed administration once every four weeks or three weeks.
Regarding claim 53, liposomal mitoxantrone is administered at dose 9-30 mg/m2 (paragraph [0109] Table 7), which reads on the claimed therapeutically effective amount of 8-30 mg/m2.
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.
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.
Claim(s) 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al.
Regarding claim 36 (as it refers to claim 34), Ahmad et al. discloses a method of treating a mammalian disease comprising: administering to a mammal a pharmaceutical composition comprising a therapeutically effective amount of mitoxantrone in a liposomal formulation (claim 1) wherein the mammal is human (claim 2) wherein disease in particular is ovarian cancer (paragraph [0031]) wherein the mitoxantrone is mitoxantrone hydrochloride (paragraph [0002]; Example 6), which reads on the claimed method of treating ovarian cancer, gastric cancer, or head and neck squamous carcinoma in a subject, comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of mitoxantrone hydrochloride liposome.
Further regarding claim 36, Ahmad et al. discloses that the liposome vesicles have a size of about 0.1 µm or less (i.e., about 100 nm or less), which overlaps the claimed range of about 30-80 nm, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding claim 37, Ahmad et al. discloses that the liposome vesicles have a size of about 0.1 µm or less (i.e., about 100 nm or less), which overlaps the claimed range of about 40-60 nm, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding claim 38, the claimed recitation of the multivalent counter ion being sulfate, citrate, or phosphate merely further limits the multivalent counter ion recited in claim 36, but such multivalent counter ion remains optional and is not required per claims 36 and 38.
Regarding claim 39, the claimed recitation of the phospholipid being a listed species merely further limits the phospholipid recited in claim 36, but such phospholipid remains optional and is not required per claims 36 and 39.
Claim(s) 34-41, 43-47, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2011/0002977 A1; published 06 January 2011).
Regarding claim 34, Li et al. discloses a method for the treatment of a tumor in a patient, which method comprises: administering a liposomal pharmaceutical preparation to a patient in need of the treatment; wherein (1) the liposomal drug comprises a multivalent ionic drug as active ingredient (claim 38) wherein cancers include gastric carcinoma and the drug is preferably mitoxantrone (paragraph [0034]) wherein doses of 2-8 mg/kg of mitoxantrone are used (Table 7) wherein mitoxantrone hydrochloride is used (Example 1).
Further regarding claim 34, although Li et al. does not disclose a single embodiment including all claimed elements, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Li et al. as discussed above and to treat gastric cancer in a patient in need thereof by administering to the patient a liposomal pharmaceutical preparation comprising mitoxantrone hydrochloride in liposomes in a dosage of 2-8 mg/kg (i.e., a therapeutically effective amount) per the methods and compositions as suggested by Li et al., with a reasonable expectation of success.
Regarding claim 35, claim 38 of Li et al. lists no other active ingredient (claim 38), which reads on the claimed mitoxantrone hydrochloride liposome being the only active ingredient in the pharmaceutical composition.
Regarding claim 36, Li et al. discloses the liposome of the liposomal drug has a size of 30-80 nm (claim 38), which reads on the claimed liposome having a particle size of about 30 to 80 nm.
Regarding claim 37, Li et al. discloses the liposome of the liposomal drug has a size of 30-80 nm (claim 38), which overlaps the claimed liposome having a particle size of about 40 to 60 nm, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding claim 38, the claimed recitation of the multivalent counter ion being sulfate, citrate, or phosphate merely further limits the multivalent counter ion recited in claim 36, but such multivalent counter ion remains optional and is not required per claims 36 and 38.
Regarding claim 39, the claimed recitation of the phospholipid being a listed species merely further limits the phospholipid recited in claim 36, but such phospholipid remains optional and is not required per claims 36 and 39.
Regarding claim 40, Li et al. discloses forming the liposome using hydrogenated soybean phosphatidylcholine, cholesterol and PEG2000-modified distearoyl phosphatidyl ethanolamine in a weight ratio of 3:1:1 (Example 2; claim 33), which reads on the claimed phospholipid bilayer in the mitoxantrone hydrochloride liposome contains hydrogenated soy phosphatidylcholine, cholesterol and PEG2000 modified distearoylphosphatidylethanolamine in a mass ratio of about 3:1:1; and Li et al. discloses that the liposome comprises a multivalent counter ion, which reads on the claimed mitoxantrone hydrochloride interacting with a multivalent acid ion in the liposome to form a poorly soluble precipitate; and Li et al. discloses that the liposome of the liposomal drug has a size of 30-80 nm (claim 38), which overlaps the claimed liposome having a particle size of about 60 nm, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I). Although Li et al. does not explicitly disclose the formation of a poorly soluble precipitate due to the interaction with the multivalent ion in the liposome, since the method and composition of Li et al. is substantially identical to the claimed method/composition, it is presumed that such property/formation is inherent in the method and composition of Li et al. per MPEP 2112(V) and 2112.01(I), given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Regarding claim 41, the claimed recitation of the ovarian cancer being a specific type merely further limits the ovarian cancer recited in claim 34, but such ovarian cancer remains optional and is not required per claims 34 and 41.
Regarding claim 43, the claimed recitation of the head and neck squamous cell carcinoma being a listed type merely further limits the head and neck squamous cell carcinoma recited in claim 34, but such head and neck squamous cell carcinoma remains optional and is not required per claims 34 and 43.
Regarding claim 44, the claimed recitation of the head and neck squamous cell carcinoma being a listed type merely further limits the head and neck squamous cell carcinoma recited in claim 34, but such head and neck squamous cell carcinoma remains optional and is not required per claims 34 and 44.
Regarding claim 45, the claimed recitation of the first line therapy being a listed type merely further limits the first line therapy recited in claim 44, but such first line therapy remains optional and is not required per claims 34 and 44-45.
Regarding claim 46, the composition is injected (paragraph [0045]; Examples 12-14 and 18-19), which reads on the claimed pharmaceutical composition being in the form of an injection.
Regarding claim 47, the composition is a solution (Examples 1-3) and is injected (paragraph [0045]; Examples 12-14 and 18-19), which reads on the claimed pharmaceutical composition being in the form of a liquid injection.
Regarding claim 50, injections were intravenous (Examples 18, 20), which reads on the claimed administration by intravenous administration.
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 34-39 and 42-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 11-19, and 22 of copending Application No. 18/564,796 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘796 claims merely recite additional elements and/or the instant claims recite optional elements and the concentration and administration time ranges overlap.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34, 36, 38-39, and 41-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-26 of copending Application No. 19/107,103 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the nasopharyngeal carcinoma of the ‘103 claims is a species of head and neck squamous carcinoma of the instant claims and the ‘103 claims merely recite additional elements and/or the instant claims recite optional elements.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617