DETIALED 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 of Claims
Claims 1, 9-13, 16-25, 27, 31-48, 51-53 and 55 are pending in the instant application. Claims 1, 9-10, 13, 18, 27, 31-32, 46 and 51-53 are amended and claims 2-8, 14-15, 26, 28-30, 49-50, 54 and 56 are cancelled via the amendment filed January 27th, 2026.
Priority
This application is a continuation of PCT/US2020/063773, filed December 8th, 2020, which claims priority to provisional applications 63/121,461, filed December 4th, 2020 and 62/945,609, filed December 9th, 2019.
Withdrawn Objections
Applicant’s arguments and amendments, filed January 27th, 2026, with respect to the objection of claim 1 have been fully considered and are persuasive. The objection of claim 1 has been withdrawn.
Applicant has overcome this objection by amending claim 1 to depict the tosylates with hydrogens.
Withdrawn Rejections
Applicant’s arguments and amendments, filed January 27th, 2026, with respect to the 112(b) rejection of claim 52 have been fully considered and are persuasive. The 112(b) rejection of claim 52 has been withdrawn.
Applicant has overcome this rejection by amending claim 52 to remove the “such as” phrases from the claim.
Response to Remarks
Applicant’s arguments with respect to the claim objections and 112(b) rejection have been considered but are moot because the amendments, filed January 27th, 2026, have overcome the objection and rejection.
Applicant's arguments filed, January 27th, 2026, with respect to the 35 U.S.C. 103 rejections of claims 1, 42-53 and 55 have been fully considered but they are not persuasive.
Applicant traverses the rejection on the grounds that Reinhoff and Pettit, individually and in combination, do not teach or suggest that the starting dose of Compound 1 is 0.5 mg/kg/d and the dosage is adjusted (increased, maintained or decreased).
On p. 12 of the remarks, Applicant argues that Reinhoff provides no specific teachings that would lead a person of skill in the art to initiate dosing at the claimed starting dose of 0.5 mg/kg/d.
In response, as stated in the previous Office action, Reinhoff teaches that compound 1 of the instant application is administer in a dosage of from 0.1 to 500 mg/kg/day (paragraph [0169]). The instantly claimed starting dosage is within this range. See MPEP 2144.05: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Further, on p. 12 of the remarks, Applicant argues that Pettit teaches an initial dosage that the is lower than the instantly claimed starting dosage. Applicant then argues that Pettit does not teach the claimed method of adjusting, increasing, decreasing or maintaining.
However, as mentioned above, Reinhoff offers the necessary motivation to arrive at the instantly claimed starting dosage. Further, Pettit teaches that the LSD1 inhibitor is administered in dosages needed to achieved the target platelet count range (page 2, paragraph 4). As such one would have been motivated to alter the dose administered in Reinhoff based on the platelet count of the subject, as Pettit teaches that the dosage changes as to have the platelet count remain in the targeted range. As the achievement of the necessary platelet count can including increasing, decreasing and maintaining, one of ordinary skill in the art would have arrived at the instantly claimed method in view of Reinhoff and Pettit.
On p. 13 of the remarks, Applicant argues that Guo does not teach or suggest a method of treating a myeloproliferative neoplasm comprising administering compound 1 at the claimed starting dosage of 0.5 mg/kg/d or a method of adjusting the subject’s daily dose based on the subject’s platelet count as set forth in the instant claims.
However, Guo was cited as a teaching showcasing that in patients with myeloproliferative neoplasms, the BOD1L1 is one of the most frequently mutated genes. Thus, motivating one of ordinary skill in the art to recognize that the method rendered obvious in view of Reinhoff and Pettit would treat a patient with a BOD1L1 mutation.
Applicant's arguments filed, January 27th, 2026, with respect to the double patenting rejections of claims 1, 42-53 and 55 have been fully considered but they are not persuasive.
On p. 14-17, Applicant traverses the double patenting rejections for the same reasons as the l for the 35 U.S.C. 103 rejections. For the reasons above, the arguments are not persuasive.
In view of the above, the 35 U.S.C. 103 rejections and double patenting rejections are maintained.
Response to Restriction/Election Requirement
Applicant’s election without traverse of Group I, drawn to a method of treating a myeloproliferative neoplasm, in the reply filed on October 10th, 2025 is acknowledged.
Claims 1, 42-48, 51-53 and 55 have been examined. Since the elected group is not allowable, subject matter not embraced by the elected embodiment, claims 9-13, 16-25, 27 and 31-41, are therefore withdrawn from further consideration.
Maintained Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
Claim(s) 1, 42-48 and 51-53 stand rejected under 35 U.S.C. 103 as being unpatentable over Rienhoff (WO 2017079753 A1, as cited on the IDS dated 10/30/2024) in view of Pettit et al (Blood, Volume 134, Supplement 1, 13 November 2019, Page 556, as cited on the IDS dated 05/28/2024).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Reinhoff teaches “lysine-specific histone demethylase as a novel therapeutic target in myeloproliferative neoplasms” (title). Reinhoff further teaches methods for treating or preventing myeloproliferative neoplasms in a subject in need thereof, and for effecting specific clinically relevant endpoints, comprising administering a therapeutically effective amount of an LSD1 inhibitor (abstract). Reinhoff discloses the LSD1 inhibitor, “Compound 1” of the instant claims (page 67):
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Further, Rienhoff teaches that myeloproliferative neoplasms includes essential thrombocythemia (paragraph [0294]). Rienhoff teaches that dose level for a particular patient will depend on factors such as severity of the indication or condition being treated (paragraph [0171]). Additionally, Rienhoff teaches that the LSD1 inhibitor may be formulated for administration at any frequency of administration including once a week, and states that such a dosing frequency is also maintained for a varying duration of time depending on the therapeutic regimen. The duration of a particular therapeutic regimen may vary from one-time dosing to a regimen that extends months or years (paragraph [0170]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Reinhoff teaches methods of treating myeloproliferative neoplasms in a subject in need thereof, and for effecting specific clinically relevant endpoints in subjects by administering an LSD1 inhibitor but does not specify that the method is sufficient to maintain in the subject a platelet count of about 50 x 109 to about 100 x 109 platelets/L.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Pettit teaches a phase 2a study of the LSD1 inhibitor Img-7289 (bomedemstat) for the treatment of myelofibrosis (title). Petti teaches the administration of the LSD1 inhibitor to patients with dosing tailored using platelet count as a biomarker (page 2, paragraph 2). Pettit teaches that patients were started at a presumed sub-therapeutic dose of 0.25 mg/kg/d and up-titrated weekly until the platelet count rested between 50 and 100K/µL (page 2, paragraph 2).
Also, Reinhoff teaches that compound 1 of the instant application is administer in a dosage of from 0.1 to 500 mg/kg/day (paragraph [0169]). Further, Pettit teaches that the LSD1 inhibitor is administered in dosages needed to achieved the target platelet count range (page 2, paragraph 4). As such one would have been motivated to alter the dose administered in Reinhoff based on the platelet count of the subject, as Pettit teaches that the dosage changes as to have the platelet count remain in the targeted range.
Regarding claim 1, as Reinhoff teaches a method of treating myeloproliferative neoplasms in a subject in need thereof comprising administering compound 1 of the instant application, one of ordinary skill in the art would have been motivated to administer compound 1 in an amount sufficient to maintain in the subject a platelet count of about 50 x 109 to about 100 x 109 platelets/L as Pettit teaches the treatment of myelofibrosis with an LSD1 inhibitor in a dosage amount that maintains a platelet count from platelet count between 50 and 100K/µL.
Regarding claim 42, Reinhoff teaches that the subject has a mutation in the gene Janus Kinase 2 (JAK2) (paragraph [0297]).
Regarding claim 43, Reinhoff teaches that the method of treatment further comprises the step of determining whether the subject has a mutation in the gene Janus Kinase 2 (JAK2) (paragraph [0295]).
Regarding claim 44, the platelet count range taught by Pettit overlaps with the range of instant claim 44. See MPEP 2144.05: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Regarding claims 45-46, Reinhoff teaches that compound 1 of the instant application is administered in a dosage of 0.1 to 500 mg/kg per day (paragraph [0169]).
Regarding claims 47-48, Reinhoff teaches that the dosage of compound 1 of the instant application is administered in a dosage of 10 mg to 200 mg per day (paragraph [0169]).
Regarding claim 50, Pettit teaches that the dose was up-titrated as needed to achieve the target platelet count range.
Regarding claim 51, Reinhoff teaches that the subject has a mutant allele (paragraph [0301]).
Regarding claim 52, Reinhoff teaches that the mutant allele is in the JAK2V617F (paragraph [0322]).
Regarding claim 53, Pettit teaches that the subjects has mutations in the U2AF1 (page 2, paragraph 3).
Claims 1, 42-48, 51-53 and 55 stand rejected under 35 U.S.C. 103 as being unpatentable over Rienhoff (WO 2017079753 A1, as cited on the IDS dated 10/30/2024) in view of Pettit et al (Blood, Volume 134, Supplement 1, 13 November 2019, Page 556, as cited on the IDS dated 05/28/2024), as applied to claims 1 42-48 and 51-53 above, which is incorporated here by reference, and in further view of Guo et al (Biomarkers, genomics, proteomics, and gene regulation, Volume 187, Issue 7, p1512-1522, July 2017).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art does not teach a single embodiment wherein the subject to be treated has a mutant allele in the BOD1L1 gene. However, Reinhoff teaches that the subject has a mutant allele.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
There is not a single embodiment wherein the subject has a mutant allele in the BOD1L1 gene.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
However, Guo teaches that in patients with myeloproliferative neoplasms, the BOD1L1 is one of the most frequently mutated genes (page 1519, left column, paragraph 1).
As Rinehoff and Pettit teaches that a method of treating a myeloproliferative neoplasm with a mutant allele and Guo teaches that the BOD1L1 is one of the most commonly mutated genes in a myeloproliferative neoplasm, one of ordinary skill in the art would recognize that the subjects in Reinhoff would have a mutant in the BOD1L1 gene.
Maintained 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 1, 42-48, 51-53 and 55 stand rejected on the ground of nonstatutory double patenting over claims 1-22 of U.S. Patent No. 10519118 in view of Rienhoff (WO 2017079753 A1, as cited on the IDS dated 10/30/2024) in view of Pettit et al (Blood, Volume 134, Supplement 1, 13 November 2019, Page 556, as cited on the IDS dated 05/28/2024) and Guo et al (Biomarkers, genomics, proteomics, and gene regulation, Volume 187, Issue 7, p1512-1522, July 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patents disclose methods of treating KDM1A-mediated diseases by administering pharmaceutical salts of the following compound:
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The patent claims that the disease is myelofibrosis (claim 21). As such, the patent claims a method of treating a myeloproliferative neoplasm with compound 1 of the instant application. The teachings of Reinhoff, Pettit and Guo relative to claims 1, 42-53 and 55 are incorporated herein by reference. The instant claims are deemed to be obvious variants of the subject matter of patent No. 10519118 for the same reasons as under 35 USC 103.
Claims 1, 42-48, 51-53 and 55 stand rejected on the ground of nonstatutory double patenting over claims 1-58 of U.S. Patent No. 11655226 in view of Rienhoff (WO 2017079753 A1, as cited on the IDS dated 10/30/2024) in view of Pettit et al (Blood, Volume 134, Supplement 1, 13 November 2019, Page 556, as cited on the IDS dated 05/28/2024) and Guo et al (Biomarkers, genomics, proteomics, and gene regulation, Volume 187, Issue 7, p1512-1522, July 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent disclose a genus of compounds that embrace the following LSD1 inhibitor of Rienhoff:
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A person of ordinary skill in the art would have been motivated to apply the compound of the patent to treat a myeloproliferative neoplasm. The teachings of Reinhoff, Pettit and Gao relative to claims 1, 42-53 and 55 are incorporated herein by reference. The instant claims are deemed to be variants of the subject matter of patent No. 11655226 for the same reasons as under 35 USC 103.
Claims 1, 42-48, 51-53 and 55 stand rejected on the ground of nonstatutory double patenting over claims 1-19 of U.S. Patent No. 9790195 in view of Rienhoff (WO 2017079753 A1, as cited on the IDS dated 10/30/2024) in view of Pettit et al (Blood, Volume 134, Supplement 1, 13 November 2019, Page 556, as cited on the IDS dated 05/28/2024) and Guo et al (Biomarkers, genomics, proteomics, and gene regulation, Volume 187, Issue 7, p1512-1522, July 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent disclose a genus of compounds that embrace the following LSD1 inhibitor of Rienhoff:
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A person of ordinary skill in the art would have been motivated to apply the compound of the patent to treat a myeloproliferative neoplasm. The teachings of Reinhoff, Pettit and Gao relative to claims 1, 42-53 and 55 are incorporated herein by reference. The instant claims are deemed to be variants of the subject matter of patent No. 9790195 for the same reasons as under 35 USC 103.
Claims 1, 42-48, 51-53 and 55 stand rejected on the ground of nonstatutory double patenting over claims 1-19 of U.S. Patent No. 9981992 in view of Rienhoff (WO 2017079753 A1, as cited on the IDS dated 10/30/2024) in view of Pettit et al (Blood, Volume 134, Supplement 1, 13 November 2019, Page 556, as cited on the IDS dated 05/28/2024) and Guo et al (Biomarkers, genomics, proteomics, and gene regulation, Volume 187, Issue 7, p1512-1522, July 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 of the patent discloses the LSD1 inhibitor, N-[(2S)-5-{[(1R, 2S)-2-(4-fluorophenyl)cyclopropyl]amino}-1-(4-methylpiperazin-1-yl)-1-oxopentan-2-yl]-4-(1H-1,2,3-triazol-1-yl)benzamide ditosylate which is identical to compound 1 of instant claim 1. A person of ordinary skill would have been motivated to apply the compound of the patent to treat LSD1 mediated myeloproliferative neoplasms. The teachings of Rienhoff, Pettit, and Guo relative to claims 1, 42-53 and 53 are incorporated here by reference. The instant claims are deemed to be variants of the subject matter of patent No. 9981922 for the same reasons as under 35 USC 103.
Claims 1, 42-48, 51-53 and 55 stand rejected on the ground of nonstatutory double patenting over claims 38, 40, 43-44 and 46-47 of copending Application No. 17/350,321 in view of Rienhoff (WO 2017079753 A1, as cited on the IDS dated 10/30/2024) in view of Pettit et al (Blood, Volume 134, Supplement 1, 13 November 2019, Page 556, as cited on the IDS dated 05/28/2024) and Guo et al (Biomarkers, genomics, proteomics, and gene regulation, Volume 187, Issue 7, p1512-1522, July 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 38 of the copending application disclose a method of maintaining leukocyte levels within a therapeutically beneficial range in a subject with myeloproliferative neoplasm comprising administering the following compound:
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Rienhoff discloses methods of treating myeloproliferative neoplasm in a subject in need thereof, and for effecting specific clinically relevant endpoints in subjects by administering the copending LSD1 inhibitor. Petiti discloses a method of treating myeloproliferative neoplasm with dosing dependent on platelet counts. The teachings of Rienhoff, Pettit and Guo et al. relative to claims 1, 42-53 and 55 are incorporated here by reference. The instant claims are deemed to be variants of the subject matter of copending claims for the same reasons as under 35 USC 103.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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