DETAILED ACTION
Claims 1-3, 5-7, 9, 11, 13, 17, 19, 21, 24-26, 29, 30, 32, 35, 36, 40, and 41 are currently pending and are rejected.
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 .
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 1-3, 5-7, 9, 11, 13, 17, 19, 21, 24-26, 29, 30, 32, 35, 36, 40, and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 12,162,870. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims claim compounds of the formula
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which overlaps with the instantly claimed utilized products in the instant method claims, provides preferences towards the instantly claimed utilized products, such as in conflicting claims 2-18, such as conflicting claim 18 which provides Rc as:
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. Additionally, conflicting claims 19-21 claim species which are within the formula I of the instantly claimed utilized products, such as the compound
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column 1513, conflicting claim 21, which corresponds to instant claims 29 utilized compound
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on page 7 of the claim set. Conflicting claim 21 also provides the compound
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on column 1550 which corresponds to the compound utilized in instant claim 29, page 7:
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Conflicting claim 21 also provides the compound on column 1593:
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which corresponds to compounds utilized wherein X is N and Y is CH or X is CH and Y is N, instant claim 17. While the instant claims are method claims drawn to the treatment of a myeloproliferative neoplasm or a myeloproliferative disease or disorder (instant claim 1) with the formula (I) such as with an additional therapy (instant claim 30) such as with a JAK inhibitor such as ruxolitinib (instant claims 32 and 35) such as with a PI3K inhibitor (instant claim 36) wherein the disease is a leukemia (instant claim 40) such as chronic eosinophilic leukemia (instant claim 41). Column 371 of the ‘870 patent provides pharmaceutical compositions with one or more additional pharmaceutically active agents. Columns 371 and 372 provide methods of treatment of cancers, such as myeloproliferative disorders including chronic eosinophilic leukemia and myelofibrosis.
With regard to obviousness-type double patenting of a method claim over a patented composition, the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
Pfizer, 518 F3d 1353 at 1363 (Fed. Cir. 2008).
Geneva, 349 F3d at 1386 (Fed. Cir. 2003).
One skilled in the art would thus be motivated to prepare products embraced by the ‘870 patent to arrive at the instant products with the expectation of obtaining additional beneficial products which would treat a myeloproliferative neoplasm or a myeloproliferative disease or disorder. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
Additionally, in regards to instant claims 32, 35, and 36, it would be obvious to have the additional therapeutic agent be a JAK inhibitor, such as ruxolitinib or a PI3K inhibitor, as seen by Tasian et al. ruxolitinib (JAK inhibitor) and idelalisib (PI4K inhibitor) are useful in the treatment of juvenile myelomonocytic leukemia, see abstract. Additionally, Haifa et al. provides ruxolitinib for the treatment of myelofibrosis, see abstract.
As the ‘870 patent provides for the treatment of cancers, such as myeloproliferative disorders including chronic eosinophilic leukemia and myelofibrosis on columns 371 and 372 and provides for an additional agent, it would have been prima facie obvious for a person having ordinary skill in the art to administer a combination of applicant’s instantly utilized product with a JAK inhibitor or a PI3K inhibitor. Per MPEP 2144.06, I. “"It 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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)”.
Claim 1-3, 5-7, 9, 11, 13, 17, 19, 21, 24-26, 29, 30, 32, 35, 36, 40, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-10 of copending Application No. 18/967,139 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because conflicting claim 2 provides the compounds:
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which anticipate the utilized compounds in applicant’s instant method claims. Compare instant claim 29 which specifically utilizes the compounds
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,
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, and
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, for example. Additionally, page 205 of the conflicting specification provides pharmaceutical compositions comprising one or more additional pharmaceutically active agents, and pages 205-207 provide the treatment of cancers, such as acute myeloid leukemia, chronic leukemia, chronic eosinophilic leukemia, myeoloproliferative disorders, myelofibrosis, etc.
With regard to obviousness-type double patenting of a method claim over a patented composition, the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
Pfizer, 518 F3d 1353 at 1363 (Fed. Cir. 2008).
Geneva, 349 F3d at 1386 (Fed. Cir. 2003).
One skilled in the art would thus be motivated to prepare products embraced by the ‘139 application to arrive at the instant products with the expectation of obtaining additional beneficial products which would treat a myeloproliferative neoplasm or a myeloproliferative disease or disorder. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
Additionally, in regards to instant claims 32, 35, and 36, it would be obvious to have the additional therapeutic agent be a JAK inhibitor, such as ruxolitinib or a PI3K inhibitor, as seen by Tasian et al. ruxolitinib (JAK inhibitor) and idelalisib (PI4K inhibitor) are useful in the treatment of juvenile myelomonocytic leukemia, see abstract. Additionally, Haifa et al. provides ruxolitinib for the treatment of myelofibrosis, see abstract.
As the ‘139 application provides for the treatment of cancers, such as myeloproliferative disorders including chronic eosinophilic leukemia and myelofibrosis on pages 205-207 and provides for an additional agent, it would have been prima facie obvious for a person having ordinary skill in the art to administer a combination of applicant’s instantly utilized product with a JAK inhibitor or a PI3K inhibitor. Per MPEP 2144.06, I. “"It 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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 3, 7, 11, 13, and 32 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.
Regarding claims 3, 7, 11, 13, and 32 instances of phrases with “e.g.” within parenthesis renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 26 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. Specifically, claim 26 further defines formula (I) of instant claim 1:
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to the formula
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, however, variable R2 and R3 are not defined in either instant claim 1 or claim 26 which renders claim 26 indefinite as it is unclear what R2 and R3 are.
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)(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) 1-3, 5-7, 9, 11, 13, 17, 19, 21, 24-26, 29, 30, 40, and 41 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2022/261204.
WO 2022/261204 discloses compounds of the formula (I) on page 2:
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. Specific compounds disclosed are, for example,
the compound on page 118:
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, page 136:
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and page 173:
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. WO 2022/261204 discloses pharmaceutical compositions on page 186 which can contain one or more additional pharmaceutically active agents. Pages 186-188 disclose the treatment of certain cancers, such as acute myeloid leukemia along with chronic leukemia, chronic eosinophilic leukemia, myeloproliferative disorders, and myelofibrosis, etc. The compounds of the ‘204 WO correspond to the compounds utilized in the instant methods for example, the compound of page 118 of the ‘204 WO:
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corresponds to applicant’s instant formula I:
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wherein R1 and Rx are taken together with the intervening atoms to form a substituted heterocycloalkyl ring, heterocycloalkenyl ring, or heteroaryl ring (instant claim 1), such as seen in formula Ia in instant claim 2:
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wherein R2 is methyl (instant claim 3); wherein Rc is heterocyclyl (instant claim 5); such as seen in instant claim 6:
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, wherein R3 is tertiary butyl (instant claim 7); wherein J is OH (instant claim 9); wherein Rb is F (instant claim 11); wherein p is 0 (instant claim 1 and 21); wherein X is N and Y is CH (instant claim 17); wherein Z is CH (instant claim 25)
The compound on page 136:
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and the compound on page 173
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of the ‘204 correspond to instant claim 19 wherein X and Y are each CH. The compound on page 173:
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provides wherein Z is N (instant claim 24). The compounds on page 136:
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and page 173:
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are identical to compounds in instant claim 29. Additionally, the ‘204 WO provides on page 128, the compound
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which corresponds to instant claim 13 wherein one instance of Ri is methoxy. As page 186 of the ‘204 WO provides pharmaceutical compositions which can contain one or more additional pharmaceutically active agents, instant claim 30 is anticipated. As pages 186-188 of the ‘204 WO disclose the treatment of certain cancers, such as acute myeloid leukemia along with chronic leukemia, chronic eosinophilic leukemia, myeloproliferative disorders, and myelofibrosis, etc., instant claims 40 and 41 are anticipated.
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
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.
Claims 32, 35, and 36 is/are rejected under 35 U.S.C. 103 as being obvious over WO 2022/261204 in view of Tasian et al. or Haifa et al.
The applied reference, WO 2022/261204, has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Determining the scope and contents of the prior art (See MPEP 2141.01)
WO 2022/261204 discloses compounds of the formula (I) on page 2:
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. Specific compounds disclosed are, for example,
the compound on page 118:
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, page 136:
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and page 173:
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. WO 2022/261204 discloses pharmaceutical compositions on page 186 which can contain one or more additional pharmaceutically active agents. Pages 186-188 disclose the treatment of certain cancers, such as acute myeloid leukemia along with chronic leukemia, chronic eosinophilic leukemia, myeloproliferative disorders, and myelofibrosis, etc.
Tasian et. al. provides ruxolitinib (JAK inhibitor) and idelalisib (PI4K inhibitor) are useful in the treatment of juvenile myelomonocytic leukemia, see abstract.
Haifa et al. provides ruxolitinib for the treatment of myelofibrosis, see abstract.
Ascertaining the differences between the prior art and the claims at issue (See MPEP 2141.02)
While providing pharmaceutical compositions on page 186 which can contain one or more additional pharmaceutically active agents, the ‘204 WO does not teach an explicit embodiment where the compounds of the formula (I) are administered with a JAK inhibitor or a PI3K inhibitor.
Finding of prima facie obviousness---rationale and motivation (See MPEP 2142-2143)
However, in regards to instant claims 32, 35, and 36, it would be obvious to have the additional therapeutic agent be a JAK inhibitor, such as ruxolitinib, or a PI3K inhibitor, as seen by Tasian et al. which provides ruxolitinib (JAK inhibitor) and idelalisib (PI4K inhibitor) useful in the treatment of juvenile myelomonocytic leukemia, see abstract. Additionally, Haifa et al. provides ruxolitinib for the treatment of myelofibrosis, see abstract.
As the ‘204 WO provides for the treatment of cancers, such as myeloproliferative disorders including chronic eosinophilic leukemia and myelofibrosis on pages 186-188 and provides for an additional agent, it would have been prima facie obvious for a person having ordinary skill in the art to administer a combination of applicant’s instantly utilized product with a JAK inhibitor or a PI3K inhibitor. Per MPEP 2144.06, I. “"It 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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 10 June 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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