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 .
Priority
The instant application is a 371 National Stage Entry of US2022/014663 filed on February 1, 2022 which claims benefit to domestic application No. 63/144,378 filed on February 1, 2021.
Status of Claims
Acknowledgement is made of original (1), amended (2-12), cancelled (13-14), and new (15-22) claims filed on August 1, 2023. Claims 1-12, 15-22 are pending in instant application.
Information Disclosure Statement
The information disclosure statement filed on August 1, 2023 has been considered except where lined through.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title should reflect the relevant structures and utility. The following title is suggested: REBECSINIB AND COMBINATION THERAPIES FOR TREATING LEUKEMIA.
Claim Objections
Claims 2, 12, 16 are objected to because of the following informalities:
Claim 2 recites “(b) a compound of (a), or rebecsinib or 17S-FD-895, and at least…” which is confusing because it appears to states the same compound three times in the alternative. Examiner suggests amending to “(b) rebecsinib and at least…” since (a) already explains “rebecsinib, also called 17S-FD-895” for clarity.
Claim 12 recites “or intramuscularly (IM).A pharmaceutical composition…second drug.” Per MPEP § 608.01(m), each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). It is unclear if the improper second sentence limitations are required by the claim or not.
Claim 16 recites “acute myeloid leukemia (AML)” twice. It appears to be a typographical error.
Appropriate correction is required.
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 2, 3, 8-12, 21 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.
Claim 2 recites “(b) a compound of (a), or rebecsinib or 17S-FD-895, and at least…” which is confusing because it appears to states the same compound three times in the alternative. Claim 2 (a) already explains rebecsinib is also 17S-FD-895, so it is unclear if they are the same or not based on the phrasing of claim 2 (b).
Claims 3 and 17 recite “wherein doses…are administered, or formulated for administration,”. This is ambiguous because the claim may read as any of the following: i) the composition is administered to a subject according to the schedule (a method of using the compositions once a day, twice a week etc.), ii) the compositions are formulated according to the schedule (e.g. a method of making the compositions once a day, twice a week, etc), or iii) the composition is formulated in a way that it can be administered according to the schedule (a composition claim), however claim 2 from which it depends is a method of using claim. It is unclear if the claim is attempting to be a product, method of manufacture, or method of using claim.
Claim 3 recites “once a day for between one to two weeks, twice a week for 2 weeks or between about one to two weeks, followed by 2 weeks rest or 2 to 4 weeks rest, with a duration of two, three, four, five or six cycles”. This is ambiguous because the claim may read as any of the following:
i) once a day for between one to two weeks, ii) twice a week for 2 weeks, or iii) twice a week for between about one to two weeks followed by two weeks rest or 2 to 4 weeks rest with a duration of two, three, four, five or six cycles
i) once a day for between one to two weeks followed by two weeks rest or 2 to 4 weeks rest with a duration of two, three, four, five or six cycles, ii) twice a week for 2 weeks followed by two weeks rest or 2 to 4 weeks rest with a duration of two, three, four, five or six cycles, or iii) twice a week for between about one to two weeks followed by two weeks rest or 2 to 4 weeks rest with a duration of two, three, four, five or six cycles
In other words, it is unclear if the “followed by” clause applies to all the alternatives or just the last. Similarly, claim 17 has the same ambiguity.
Claims 8, 9, 12, 21 recite “optionally” limitations. Notably, claim 9 recites “(optionally sterile saline or water)” once and “optionally” multiple times. The use of “optionally” in these instances appear to be a stand-in for “such as" or “for example” which renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding claim 21, all the claim limitations as written are optional, it is unclear what the metes and bounds of what is comprised encompass or exclude are. In addition, claim 21 recites “and vindesine or eldisine” so it is unclear if the optional species are in the alternative or not.
Claim 8 contains trademark/trade names. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe alternative telomerase inhibitor species and, accordingly, the identification/description is indefinite.
Claim 9 recites “or equivalents” multiple times. The instant specification does not define what “equivalents” include or exclude thus the metes and bounds of the claim are unclear.
Claim 10 recites “500 to 1 g a day”. It is unclear if 1 - 500 g or 500 mg – 1g was intended.
Claim 11 recites “such as” which 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 11 recites “drugs is administrated as or formulated with or formulated as”. It is unclear if claim 11 is attempting to be a product claim (formulated as), a method of manufacture claim (formulated with), or a method of using claim (administered as).
Claim 12 recites “or intramuscularly (IM).A pharmaceutical composition… second drug.”. Per MPEP § 608.01(m), each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). It is unclear if the improper second sentence limitations are required by the claim or not.
Claims 10-12 recite the limitation "the method" and depend from claim 1 (“a pharmaceutical or therapeutic composition”). There is insufficient antecedent basis for this limitation in the claim.
For the purposes of applying art:
Claims 3 and 17 are construed as methods of using, drawn to an administration schedule, wherein the “followed by” rest period may or may not be present.
Claim 10 is construed as a composition with an intended dosage cycle depending from claim 1.
Claim 11 is construed as a composition depending from claim 1, formulated for oral, IV, SC, IM, inhaled administration.
Claim 12 is construed as a method depending from claim 2.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.— Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10, 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 is drawn to a “method” (see above 35 U.S.C. 112(b)) but is interpreted as a composition with intended use (a dosage administration cycle). The intended use does not further structurally limit the claim, and the claim limitations are fully satisfied by the structures set forth in claim 1.
Claim 21’s limitations are all optional. It is unclear how the claim further limits from claim 6.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1, 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crews et. al.1 as evidenced by Swanson et. al.2
Regarding claims 1, 10, and a composition comprising rebecsinib and a second drug, Crews teaches 17S-FD-895 is a spliceosome modulator (see Crews at Graphical Abstract and “In Brief”). Crews teaches preparing 17S-FD-895 in DMSO at a concentration of 10 mg/mL (see Crews at p. 610 left col. ¶3). Swanson explains DMSO is a drug used for medicinal purposes (see Swanson). The composition taught by Crews comprising 17S-FD-895 and DMSO thus reads on a composition comprising rebecsinib and a second drug.
Regarding claim 11 and formulated for IV administration, Crews teaches intravenously administering the composition (see Crews at p. 610 left col. ¶5).
Claims 2, 12, 3, 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crews.
Regarding claims 2, 12 and a method comprising administering rebecsinib, Crews teaches administering 17S-FD-895 in DMSO to AML engrafted mice intravenously (see Crews at p. 610 left col. ¶5). Crews teaches 17S-FD-895 decreased human leukemic cells in CD34+ recipient mice compared to controls (see Crews at p. 607 Figure 6E)., which reads on “treating and ameliorating a cancer”. Crews teaches 17S-FD-895 reduced AML LSC burden (see Crews at p. 607 right col. ¶1), which reads on “in vivo inhibition of AML stem cell propagation”. Crews teaches 17S-FD-895 inhibits AML splicesomes (see Crews at p. 609 left col. ¶1 and at pl 609 left col. ¶3) in vivo (see Crews at p. 608 Figure 7), which reads on “in vivo inhibition of splicesomes in AML”. HSC and HSPC are understood to read on pre-LSC cells (see Crews at Abstract). Crews teaches in 17S-FD-895 treated mouse bone marrow reversed to normal progenitor frequencies (see Crews at p. 607 Figure 6C and D and left col.) reading on “inhibition or pre-leukemia stem cell transformation into leukemia stem cells”.
Regarding claims 3, 17 and a dosage schedule, Crews teaches administering to mice three times over a 14-day period (see Crews at p. 610 left col. ¶5), which reads on “twice a week for between about one to two weeks”.
Regarding claims 15-16 and treating leukemia, Crews teaches administering to AML engrafted mice (see Crews at p. 610 left col. ¶5), AML being acute myeloid leukemia (see Crews at Abstract).
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0296524 A13 to Jamieson as evidenced by Crews.
Regarding claims 2 and treating a cancer comprising administering rebecsinib, Jamieson teaches a method for treating AML comprising administering to a subject an effective amount of a splicing modulator (see Jamieson claim 1). Jamieson teaches wherein the splicing modulator may be a compound of Formula I such as Formula (XI) (see Jamieson claim 83). Crews teaches the compound of the same Formula XI is 17S-FD-895 (see Crews at p. 605 Figure 4A).
Jamieson Formula (XI)
17S-FD-895
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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.
Claims 4, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Crews as applied to claims 2, 12, 3, 15-17 above and in further view of Marcucci et. al.4
The prior art differs from the instant claims as follows: While Crews teaches administering rebecsinib for treating acute myeloid leukemia, Crews does not teach further administering dasatinib.
However,
Regarding claims 4, 18 and combination with ATP-competitive protein tyrosine kinase inhibitor dasatinib, Marcucci teaches acute myeloid leukemia patients with KIT mutations result in worse outcomes (see Marcucci at pp. 1-2). Marcucci teaches administering dasatinib along with chemotherapy is beneficial to this subset of patients (see Marcucci at Title and p. 3).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.06(I), "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to one skilled in the art to modify Crews’ rebecsinib composition to include dasatinib because the prior art teaches it is useful for treating acute myeloid leukemia (as taught by Marcucci) with a reasonable expectation of success because each component (rebecsinib and dasatinib) is performing it’s art recognized function together as it is separately (treating AML).
Furthermore, it is well-within the ordinary skill in art to combine two known AML treatments for the same purpose as taught by the prior art (treating AML).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 5, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Crews as applied to claims 2, 12, 3, 15-17 above and in further view of Blair et. al.5 and Wernig et. al.6 as evidenced by STN7 and Tefferi et. al. 8
The prior art differs from the instant claims as follows: While Crews teaches administering rebecsinib for treating acute myeloid leukemia, Crews does not teach further administering a JAK2 inhibitor such as fedratinib or a dosage schedule of fedratinib, or specify rebecsinib for myeloproliferative neoplasm treatment.
However,
Regarding claim 2 and rebecsinib for myeloproliferative neoplasm treatment, Crews states “myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPNs), and therapy-resistant secondary acute myeloid leukemia (sAML) harbor characteristic splicing factor mutations, suggesting that the accumulation of DNA mutations over time is a major determinant of lifetime leukemia risk” (see Crews at p. 599 right col. ¶1). Crews teaches 17S-FD-895 is a spliceosome modulator (see Crews at Graphical Abstract and “In Brief”).
Regarding claims 5, 19, 20 and fedratinib, fedratinib is approved as a JAK2-selective inhibitor for oral treatment in myelofibrosis (see Blair at Abstract) in adult patients (see Blair at p. 1719 right col ¶2), a kind of myeloproliferative neoplasm (see Blair at p. 1719 left col. ¶1). Myelofibrosis can progress into leukemia (see Blair at p. 1719 right col. ¶2). Wernig teaches dosaging of TG101348 at 60 mg/kg (see Wernig at p. 316 Figure 4C and at p. 318 right col. ¶3) including twice a day (see Wernig at p. 313 left col ¶1) for treating a disease model induced by a gene mutation associated with polycythemia vera (see Wernig at Abstract, and at p. 311 right col. ¶2). STN explains that TG101348 is fedratrinib (see STN). Tefferi explains polycythemia vera is a myeloproliferative neoplasm (see Tefferi at Abstract).In addition, Blair states "local prescribing information should be consulted for detailed information regarding dose modifications for the management of adverse events", and notes that coadministration of fedratinib with some known drugs requires reduced dosage (see Blair at p. 1719 right. Col. ¶2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding claim 2 and rebecsinib for myeloproliferative neoplasm treatment, one skilled in the art would recognize spliceosome modulator 17S-FD-895 would be suitable for treating splicing factor mutation conditions such as myeloproliferative neoplasms based on the teachings of Crews, because Crews teaches 17S-FD-895’s ability to modulate spliceosomes is what makes it a treatment option for acute myeloid leukemia.
Regarding claims 5, 19, 20 and fedratinib, per MPEP § 2144.06(I), "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to one skilled in the art to modify Crews’ rebecsinib composition to include fedratinib because the prior art teaches it is useful for treating myeloproliferative neoplasms (as taught by Blair) with a reasonable expectation of success because each component (rebecsinib and fedratinib) is performing their art recognized function together as it is separately (treating myeloproliferative neoplasms). In addition, it would have been obvious to one skilled in the art to dosage fedratinib at 60 mg/kg because the prior art teaches administering fedratinib at 60 mg/kg (as taught by Wernig as evidenced by STN) is suitable for treating a myeloproliferative neoplasm disease model (as taught by Wernig as evidenced by Tefferi). Moreover, the prior art suggests optimizing fedratinib doses for patients (as taught by Blair).
Furthermore, it is well-within the ordinary skill in art to combine two known MPN treatments for the same purpose as taught by the prior art (treating MPN).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 6, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Crews as applied to claims 2, 12, 3, 15-17 above and in further view of Lowenberg et. al.9
The prior art differs from the instant claims as follows: While Crews teaches administering rebecsinib for treating acute myeloid leukemia, Crews does not teach further administering a chemotherapeutic agent such as cytarabine.
However,
Regarding claims 6, 21 and cytarabine, cytarabine is a well-known treatment for AML (see Lowenberg at Abstract), the prior art even dubbing it a "cornerstone drug in the treatment of acute myeloid leukemia" (see Lowenberg at p. 1028 left col. ¶1). Cytabarine is known to be used in combination therapy (see Lowenberg at p. p. 1028 left col. ¶1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.06(I), "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to one skilled in the art to modify Crews’ rebecsinib composition to include cytabarine because the prior art teaches it is useful for treating acute myeloid leukemia (as taught by Lowenberg) with a reasonable expectation of success because each component (rebecsinib and cytabarine) is performing its art recognized function together as it is separately (treating AML).
Furthermore, it is well-within the ordinary skill in art to combine two known AML treatments for the same purpose as taught by the prior art (treating AML).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 7, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Crews as applied to claims 2, 12, 3, 15-17 above and in further view of Malik et. al.10
The prior art differs from the instant claims as follows: While Crews teaches administering rebecsinib for treating acute myeloid leukemia, Crews does not teach further administering a hypomethylating agent such as decitabine.
However,
Regarding claims 7, 22 and decitabine, decitabine is a hypomethylating agent that has been investigated as a frontline therapy for untreated high-risk elderly AML patients and is used off-label due to its ability to significantly improve remission rates (see Malik at Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.06(I), "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to one skilled in the art to modify Crews’ rebecsinib composition to include decitabine because the prior art teaches it is useful for treating acute myeloid leukemia (as taught by Malik) with a reasonable expectation of success because each component (rebecsinib and decitabine) is performing its art recognized function together as it is separately (treating AML).
Furthermore, it is well-within the ordinary skill in art to combine two known AML treatments for the same purpose as taught by the prior art (treating AML).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Crews as applied to claims 2, 12, 3, 15-17 above and in further view of Wang et. al.11 as evidenced by Tefferi et. al.12
The prior art differs from the instant claims as follows: While Crews teaches administering rebecsinib for treating acute myeloid leukemia, Crews does not teach further administering a telomerase inhibitor, or specify rebecsinib for myeloproliferative neoplasm treatment.
However,
Regarding claim 2 and rebecsinib for myeloproliferative neoplasm treatment, Crews states “myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPNs), and therapy-resistant secondary acute myeloid leukemia (sAML) harbor characteristic splicing factor mutations, suggesting that the accumulation of DNA mutations over time is a major determinant of lifetime leukemia risk” (see Crews at p. 599 right col. ¶1). Crews teaches 17S-FD-895 is a spliceosome modulator (see Crews at Graphical Abstract and “In Brief”).
Regarding claim 8 and a telomerase inhibitor, Wang teaches imetelstat treats myelofibrosis by inhibition of telomerase activity and the induction of apoptosis (see Wang at Abstract). Tefferi explains myelofibrosis is a kind of myeloproliferative neoplasm (see Tefferi at p. 103 left col. "Myelofibrosis").
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding claim 2 and rebecsinib for myeloproliferative neoplasm treatment, one skilled in the art would recognize spliceosome modulator 17S-FD-895 would be suitable for treating splicing factor mutation conditions such as myeloproliferative neoplasms based on the teachings of Crews, because Crews teaches 17S-FD-895’s ability to modulate spliceosomes is what makes it a treatment option for acute myeloid leukemia.
Regarding claim 8 and a telomerase inhibitor, per MPEP § 2144.06(I), "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to one skilled in the art to modify Crews’ rebecsinib composition to include imetelstat because the prior art teaches it is useful for treating myeloproliferative neoplasms (as taught by Wang and Tefferi) with a reasonable expectation of success because each component (rebecsinib and imetelstat) is performing their art recognized function together as it is separately (treating myeloproliferative neoplasms).
Furthermore, it is well-within the ordinary skill in art to combine two known MPN treatments for the same purpose as taught by the prior art (treating MPN).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 1, 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0296524 A113 to Jamieson as evidenced by Crews.
Recall Jamieson teaches administering 17S-FD-895 for treating AML as discussed above.
The prior art differs from the instant claims as follows: While Jamieson teaches administering rebecsinib for treating acute myeloid leukemia, Jamieson does not specify a composition comprising rebecsinib and another drug.
However,
Jamieson teaches the disclosed preparations can also be combined with other active substances (see Jamieson at p. 16 ¶[0132]), that splice modulators such as 17S-FD-895 may represent a key component of combination therapeutic strategies aimed at AML (see Jamieson at p.18 ¶[0151]), and that it is important to perform combination treatment studies of 17S-FD-895 in combination with other epigenetic modifier therapies (see Jamieson at ¶[0295]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. It would have been obvious to one skilled in the art to combine 17S-FD-895 with another drug to form the instantly claimed composition because the prior art suggests combining 17S-FD-895 with another active substance for a combination therapeutic strategy.
Furthermore, it is well-within the ordinary skill in art to combine two known AML treatments for the same purpose as taught by the prior art (treating AML).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
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.
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Claims 1-12, 15-16, 18-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-10, 13 of copending Application No. 18/273,71614 (reference application) in view of Wernig as evidenced by STN. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 2, 3, 10, 15, 16, 17, App’716 claims a method of treating a cancer such as acute myeloid leukemia, comprising administering 17S-FD-895 and another drug (see App’716 claim 1). App’716 also claims a composition comprising 17S-FD-895 and another drug (see App’716 claim 10).
Regarding instant claims 4, 18, App’716 claims wherein a second drug is ATP-competitive protein kinase inhibitor dasatinib (see App’716 claim 2).
Regarding instant claim 5, 19, App’716 claims wherein a second drug may be a JAK2 kinase inhibitor such as fedratinib (see App’716 claim 1).
Regarding instant claims 6, 21, App’716 claims wherein a second drug is a chemotherapeutic agent such as cytarabine (see App’716 claim 3).
Regarding instant claims 7, 22, App’716 claims wherein a second drug is a hypomethylating agent such as decitabine (see App’716 at claim 4).
Regarding instant claim 8, App’716 claims wherein a second drug is a telomerase inhibitor (see App’716 at claim 5).
Regarding instant claim 9, App’716 claim 6 corresponds with the limitations of instant claim 9.
Regarding instant claim 10, App’716 claim 7 corresponds with the limitations of instant claim 10.
Regarding instant claim 11, App’716 claim 8 corresponds with the limitations of instant claim 11.
Regarding instant claim 12, App’716 claims 9 and 13 corresponds with the limitations of instant claim 12.
Regarding claim 20 and fedratinib, Wernig teaches dosaging of TG101348 at 60 mg/kg (see Wernig at p. 316 Figure 4C and at p. 318 right col. ¶3), including twice a day (see Wernig at p. 313 left col ¶1). STN explains that TG101348 is fedratrinib (see STN).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 52 of copending Application No. 17/632,76415 (reference application) Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, App’764 claims a composition comprising 17S-FD-895 and a pharmaceutically acceptable excipient (see App’764 claim 52).
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No.10,675,267 B216 as evidenced by Crews. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 2, US’267 claims a method for treating AML, including sAML (US’267 claim 4), in a subject comprising administering a compound of Formula I (US’267 claim 1) such as Formula XI (US’267 claim 3). Crews teaches the compound of the same Formula XI is 17S-FD-895 (see Crews at p. 605 Figure 4A).
US’267 Formula (XI)
17S-FD-895
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206
462
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208
487
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Conclusion
Claims 2, 12 and 16 are objected to.
Claims 1-12 and 15-22 are rejected.
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/S.R./ Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Crews et. al. "RNA Splicing Modulation Selectively Impairs Leukemia Stem Cell Maintenance in Secondary Human AML" Cell Stem Cell 2016, 19, 599-612. DOI: 10.1016/j.stem.2016.08.003 Hereinafter Crews.
2 Swanson, B. "Medical use of dimethyl sulfoxide (DMSO)" Reviews in Clinical & Basic Pharmacology 1985, 5, 1-2, 1-33. PMID: 3916302 Abstract Only. Hereinafter Swanson.
3 Filed September 23, 2016. Published October 18, 2018. Cite No. 1 in the IDS filed 8/1/23. Hereinafter Jamieson.
4 Marcucci et. al. "Adding KIT Inhibitor Dasatinib (DAS) to Chemotherapy Overcomes the Negative Impact of KIT Mutation/over Expression in Core Binding Factor (CBF) Acute Myeloid Leukemia (AML): Results from CALGB 10801 (Alliance)" Blood 2014, 124, 21, 8, 1-4. DOI: 10.1182/blood.V124.21.8.8 Hereinafter Marcucci.
5 Blair, "Fedratinib: First Approval" Drugs 2019, 79, 1719-1725. DOI: 10.1007/s40265-019-01205-x Hereinafter Blair.
6 Wernig et. al. "Efficacy of TG101348, a Selective JAK2 Inhibitor, in Treatment of a Murine Model of JAK2V617F-Induced Polycythemia Vera" Cancer Cell 2008, 13, 311-320. DOI: 10.1016/j.ccr.2008.02.009 Hereinafter Wernig.
7 CAS 936091-26-8 CAS Registry File Accessed February 12, 2026 from STN, entered into STN May 30, 2007 Hereinafter STN.
8 Tefferi et. al. "Myeloproliferative neoplasms" JAMA Oncology 2015, 1, 1, 97-105. DOI: 10.1001/jamaoncol.2015.89 Hereinafter Tefferi.
9 Lowenberg et. al. "Cytarabine Dose for Acute Myeloid Leukemia" N Engl J Med 2011, 364, 11, 1027-1036. DOI: I: 10.1056/NEJMoa1010222 Hereinafter Lowenberg.
10 Malik et. al. "Decitabine in the treatment of acute myeloid leukemia in elderly patients" Cancer Management and Research 2014, 6, 53-61. DOI: 10.2147/CMAR.S40600 Hereinafter Malik.
11 Wang et. al. "Imetelstat, a telomerase inhibitor, is capable of depleting myelofibrosis stem and progenitor cells" Blood Adv 2018, 2, 18, 2378-2388. DOI: 10.1182/bloodadvances.2018022012
Hereinafter Wang.
12 Tefferi et. al. "Myeloproliferative neoplasms" JAMA Oncology 2015, 1, 1, 97-105. DOI: 10.1001/jamaoncol.2015.89 Hereinafter Tefferi.
13 Filed September 23, 2016. Published October 18, 2018. Cite No. 1 in the IDS filed 8/1/23. Hereinafter Jamieson.
14 Filed July 21, 2023, 371 of PCT/US2022/013398 filed July 21, 2022, claims benefit to provisional application 63/140,725. Hereinafter App’716.
15 Filed 2/3/22, 371 of PCT/US2020/045066 filed 8/5/20, claims benefit to 62/883,491 filed 8/6/19. The Examiner notes a Notice of Allowance has been mailed 2/3/26, which when issued, would modify the rejection from provisional to non-provisional.
16 Filed 9/23/16, patented 6/9/20. Hereinafter US’267.