Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
This application is a continuation of 17/751153, now abandoned, filed May 23, 2022, which is a continuation of US application 16/985404, now US patent 11370781, filed August 5, 2020, which is a continuation of US application 16/372657, now US patent 10787440, which is a continuation of US application 14/394463, now US patent 10301290, filed October 14, 2014, which is a national stage application of PCT/US2013/036452, filed April 12, 2013, which claims benefit of provisional applications 61/785169, filed March 14, 2013, and 61/624194, filed April 13, 2012. Claims 21-49 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted December 20, 2024, is acknowledged wherein claims 1-20 are canceled and new claims 21-49 are introduced.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because the present specification repeatedly makes reference to SEQ ID NO: 1, 3, 5, and 11, and claims 29 and 39 furthermore additionally refer to said sequences.
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Drawings
The drawings are objected to because they are not fully legible. Specifically, figures 2-5, 8A, and 9 contain graphs having labels and legends comprising text having a small font size and low resolution such that they cannot be clearly perceived. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 29, 39, and 49 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. These claims refer to SEQ ID NO: 1, 3, 5, 6, and 21. However, no sequence listing is provided in this application, rendering these claims indefinite.
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 21, 25, 30, 33, 35, 40, 43, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 4 of U.S. Patent No. 11491163 (Cited in PTO-1449, herein referred to as ‘163) in view of Cheson et al. (Reference included with PTO-892)
Claim 1 of ‘163 claims a method of treating cancer comprising administering to a subject in need thereof a compound having the same structure as the compound recited in present claims 21, 30, and 40. Dependent claims 3 and 4 further specify that the cancer is selected from a group of lymphomas including follicular lymphoma. The claims of ‘163 do not disclose methods further comprising administering rituximab and/or lenalidomide to the subject. However, Cheson et al. discloses that biologic agents such as rituximab are used to treat follicular lymphoma. (p. 306, introduction) Cheson further discloses the use of lenalidomide for treating follicular lymphoma, either alone or in combination with rituximab. (p. 308, “immunomodulatory drugs”)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapeutic method described in the claims of ’163 in combination with lenalidomide and rituximab. One of ordinary skill in the art would have seen the prior art as suggesting administering all of these agents together in view of the fact that they are all disclosed as useful for treating the same condition, namely follicular lymphoma.
Claims 24, 34, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 4 of U.S. Patent No. 11491163 (Cited in PTO-1449, herein referred to as ‘163) in view of Cheson et al. (Reference included with PTO-892) further in view of Bastin et al. (Reference included with PTO-892)
The claims of ‘163 and the disclosure of Cheson et al. are discussed above. ‘163 in view of Cheson et al. does not disclose a method wherein the pharmaceutically acceptable salt of the disclosed compound is a hydrobromide salt. However, Bastin et al. discloses that drug candidates are often prepared as various pharmaceutically acceptable salts in order to determine an optimal form to be used in a pharmaceutical formulation. (p. 427 right column last paragraph – p. 428 right column second paragraph) Hydrobromide is disclosed as one of the commonly used inorganic anions.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use hydrobromide as the pharmaceutically acceptable salt of the compound recited in the claims of ‘163. One of ordinary skill in the art would have seen the mention of pharmaceutically acceptable salts in the claims of the issued patent as suggesting looking to the art for examples of suitable salts in order to test which ones resulted in appropriate pharmaceutical formulations.
Claims 21, 25, 30, 33, 35, 40, 43, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 12, and 13 of U.S. Patent No. 12251386 (Cited in PTO-1449, herein referred to as ‘386) in view of Cheson et al. (Reference included with PTO-892)
Claim 1 of ‘386 claims a method of treating cancer comprising administering to a subject in need thereof a compound having the same structure as the compound recited in present claims 21, 30, and 40. Dependent claims 3 and 4 further specify that the cancer is selected from a group of lymphomas including follicular lymphoma. The claims of ‘386 do not disclose methods further comprising administering rituximab and/or lenalidomide to the subject. However, Cheson et al. discloses that biologic agents such as rituximab are used to treat follicular lymphoma. (p. 306, introduction) Cheson further discloses the use of lenalidomide for treating follicular lymphoma, either alone or in combination with rituximab. (p. 308, “immunomodulatory drugs”)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapeutic method described in the claims of 386 in combination with lenalidomide and rituximab. One of ordinary skill in the art would have seen the prior art as suggesting administering all of these agents together in view of the fact that they are all disclosed as useful for treating the same condition, namely follicular lymphoma.
Claims 24, 34, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 12, and 13 of U.S. Patent No. 12251386 (Cited in PTO-1449, herein referred to as ‘386) in view of Cheson et al. (Reference included with PTO-892) further in view of Bastin et al. (Reference included with PTO-892)
The claims of ‘386 and the disclosure of Cheson et al. are discussed above. ‘386 in view of Cheson et al. does not disclose a method wherein the pharmaceutically acceptable salt of the disclosed compound is a hydrobromide salt. However, Bastin et al. discloses that drug candidates are often prepared as various pharmaceutically acceptable salts in order to determine an optimal form to be used in a pharmaceutical formulation. (p. 427 right column last paragraph – p. 428 right column second paragraph) Hydrobromide is disclosed as one of the commonly used inorganic anions.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use hydrobromide as the pharmaceutically acceptable salt of the compound recited in the claims of ‘386. One of ordinary skill in the art would have seen the mention of pharmaceutically acceptable salts in the claims of the issued patent as suggesting looking to the art for examples of suitable salts in order to test which ones resulted in appropriate pharmaceutical formulations.
Claims 21-23, 25, 30-33, 35, 40-43, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 9, and 10 of U.S. Patent No. 10787440. (Cited in PTO-1449, herein referred to as ‘440) Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 7 of ‘440 claim a method comprising administering a combination of the same compound recited in present claims 21, 30, and 40, in combination with rituximab, as recited in present claim 30, thereby anticipating claim 30. Dependent claim 2 of ‘440 claims a method wherein the compound and the rituximab are administered separately as recited in present claim 35. Claims 4-6 of ‘440 require that the follicular lymphoma is refractory and that the subject have received a previous therapy, as recited in present claims 31 and 32.
Furthermore regarding claims 21-23, 35, 33, 40-43, and 45, claims 9-18 claim methods further comprising lenalidomide, anticipating these claims.
Claims 24, 34, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 9, and 10 of U.S. Patent No. 10787440 (Cited in PTO-1449, herein referred to as ‘440) in view of Bastin et al. (Reference included with PTO-892)
The claims of ‘440 are discussed above. ‘440 does not disclose a method wherein the pharmaceutically acceptable salt of the disclosed compound is a hydrobromide salt. However, Bastin et al. discloses that drug candidates are often prepared as various pharmaceutically acceptable salts in order to determine an optimal form to be used in a pharmaceutical formulation. (p. 427 right column last paragraph – p. 428 right column second paragraph) Hydrobromide is disclosed as one of the commonly used inorganic anions.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use hydrobromide as the pharmaceutically acceptable salt of the compound recited in the claims of ‘440. One of ordinary skill in the art would have seen the mention of pharmaceutically acceptable salts in the claims of the issued patent as suggesting looking to the art for examples of suitable salts in order to test which ones resulted in appropriate pharmaceutical formulations.
Claims 21, 22, 25-28, 30, 31, 33, 35-38, 40, 41, 43, and 45-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, and 8 of U.S. Patent No. 9175331 (Cited in PTO-1449, herein referred to as ‘331) in view of Cheson et al. (Reference included with PTO-892).
Claims 1 and 3 of ‘331 claim a method of treating cancer comprising administering to a subject a compound having the same structure recited in present claims 21, 30, and 40. Claims 7 and 8 of ‘331 further specify that the cancer is selected from a list including follicular lymphoma. Furthermore claims 1 and 3 specify that the subject has an EZH2 mutation at amino acid position 641, such as Y641F, Y641H, Y641N, or Y641S, as recited in present claims 26-28, 35-38, and 45-48.
The claims of ‘331 do not disclose methods further comprising administering rituximab and/or lenalidomide to the subject. However, Cheson et al. discloses that biologic agents such as rituximab are used to treat follicular lymphoma. (p. 306, introduction) Cheson further discloses the use of lenalidomide for treating follicular lymphoma, either alone or in combination with rituximab. (p. 308, “immunomodulatory drugs”)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapeutic method described in the claims of ‘331 in combination with lenalidomide and rituximab. One of ordinary skill in the art would have seen the prior art as suggesting administering all of these agents together in view of the fact that they are all disclosed as useful for treating the same condition, namely follicular lymphoma.
Claims 24, 34, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, and 8 of U.S. Patent No. 9175331 (Cited in PTO-1449, herein referred to as ‘331) in view of Cheson et al. (Reference included with PTO-892) further in view of Bastin et al. (Reference included with PTO-892)
The claims of ‘331 and the disclosure of Cheson et al. are discussed above. ‘331 in view of Cheson et al. does not disclose a method wherein the pharmaceutically acceptable salt of the disclosed compound is a hydrobromide salt. However, Bastin et al. discloses that drug candidates are often prepared as various pharmaceutically acceptable salts in order to determine an optimal form to be used in a pharmaceutical formulation. (p. 427 right column last paragraph – p. 428 right column second paragraph) Hydrobromide is disclosed as one of the commonly used inorganic anions.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use hydrobromide as the pharmaceutically acceptable salt of the compound recited in the claims of ‘331. One of ordinary skill in the art would have seen the mention of pharmaceutically acceptable salts in the claims of the issued patent as suggesting looking to the art for examples of suitable salts in order to test which ones resulted in appropriate pharmaceutical formulations.
Claims 21, 22, 25-27, 30, 31, 33, 35-37, 40, 41, 43, and 45-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 12, and 15 of U.S. Patent No. 8765732 (Cited in PTO-1449, herein referred to as ‘732) in view of Cheson et al. (Reference included with PTO-892).
Claims 1 and 11 of ‘732 claim a method of treating cancer comprising administering to a subject a compound having the same structure recited in present claims 21, 30, and 40. Claim 12 of ‘732 further specifies that the cancer is selected from a list including follicular lymphoma. Furthermore claim 15 specifies that the subject has an EZH2 mutation at amino acid position 641, as recited in present claims 26-27, 35-37, and 45-47.
The claims of ‘732 do not disclose methods further comprising administering rituximab and/or lenalidomide to the subject. However, Cheson et al. discloses that biologic agents such as rituximab are used to treat follicular lymphoma. (p. 306, introduction) Cheson further discloses the use of lenalidomide for treating follicular lymphoma, either alone or in combination with rituximab. (p. 308, “immunomodulatory drugs”)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapeutic method described in the claims of ‘732 in combination with lenalidomide and rituximab. One of ordinary skill in the art would have seen the prior art as suggesting administering all of these agents together in view of the fact that they are all disclosed as useful for treating the same condition, namely follicular lymphoma.
Claims 24, 34, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 12, and 15 of U.S. Patent No. 8765732 (Cited in PTO-1449, herein referred to as ‘732) in view of Cheson et al. (Reference included with PTO-892) further in view of Bastin et al. (Reference included with PTO-892)
The claims of ‘732 and the disclosure of Cheson et al. are discussed above. ‘732 in view of Cheson et al. does not disclose a method wherein the pharmaceutically acceptable salt of the disclosed compound is a hydrobromide salt. However, Bastin et al. discloses that drug candidates are often prepared as various pharmaceutically acceptable salts in order to determine an optimal form to be used in a pharmaceutical formulation. (p. 427 right column last paragraph – p. 428 right column second paragraph) Hydrobromide is disclosed as one of the commonly used inorganic anions.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use hydrobromide as the pharmaceutically acceptable salt of the compound recited in the claims of ‘732. One of ordinary skill in the art would have seen the mention of pharmaceutically acceptable salts in the claims of the issued patent as suggesting looking to the art for examples of suitable salts in order to test which ones resulted in appropriate pharmaceutical formulations.
Claims 21, 22, 25, 30, 31, 33, 35, 40, 41, 43, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 20 of U.S. Patent No. 9549931 (Cited in PTO-1449, herein referred to as ‘931) in view of Cheson et al. (Reference included with PTO-892).
Claims 1 and 20 of ‘931 claim a method of treating cancer comprising administering to a subject a compound having the same structure recited in present claims 21, 30, and 40. Claims 2-4 of ‘931 further specifies that the cancer is selected from a list including follicular lymphoma
The claims of ‘931 do not disclose methods further comprising administering rituximab and/or lenalidomide to the subject. However, Cheson et al. discloses that biologic agents such as rituximab are used to treat follicular lymphoma. (p. 306, introduction) Cheson further discloses the use of lenalidomide for treating follicular lymphoma, either alone or in combination with rituximab. (p. 308, “immunomodulatory drugs”)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapeutic method described in the claims of ‘931 in combination with lenalidomide and rituximab. One of ordinary skill in the art would have seen the prior art as suggesting administering all of these agents together in view of the fact that they are all disclosed as useful for treating the same condition, namely follicular lymphoma.
Claims 24, 34, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 20 of U.S. Patent No. 9549931 (Cited in PTO-1449, herein referred to as ‘931) in view of Cheson et al. (Reference included with PTO-892) further in view of Bastin et al. (Reference included with PTO-892)
The claims of ‘931 and the disclosure of Cheson et al. are discussed above. ‘931 in view of Cheson et al. does not disclose a method wherein the pharmaceutically acceptable salt of the disclosed compound is a hydrobromide salt. However, Bastin et al. discloses that drug candidates are often prepared as various pharmaceutically acceptable salts in order to determine an optimal form to be used in a pharmaceutical formulation. (p. 427 right column last paragraph – p. 428 right column second paragraph) Hydrobromide is disclosed as one of the commonly used inorganic anions.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use hydrobromide as the pharmaceutically acceptable salt of the compound recited in the claims of ‘931. One of ordinary skill in the art would have seen the mention of pharmaceutically acceptable salts in the claims of the issued patent as suggesting looking to the art for examples of suitable salts in order to test which ones resulted in appropriate pharmaceutical formulations.
Claims 21, 22, 24, 25, 30, 31, 33-35, 40, 41, and 43-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 7 of U.S. Patent No. 12161645 (Cited in PTO-1449, herein referred to as ‘645) in view of Cheson et al. (Reference included with PTO-892).
Claims 1 and 3 of ‘645 claim a method of treating follicular lymphoma comprising administering to a subject a compound having the same structure recited in present claims 21, 30, and 40. Claim 7 of ‘645 further specifies that het compound is a hydrobromide salt.
The claims of ‘645 do not disclose methods further comprising administering rituximab and/or lenalidomide to the subject. However, Cheson et al. discloses that biologic agents such as rituximab are used to treat follicular lymphoma. (p. 306, introduction) Cheson further discloses the use of lenalidomide for treating follicular lymphoma, either alone or in combination with rituximab. (p. 308, “immunomodulatory drugs”)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapeutic method described in the claims of ‘645 in combination with lenalidomide and rituximab. One of ordinary skill in the art would have seen the prior art as suggesting administering all of these agents together in view of the fact that they are all disclosed as useful for treating the same condition, namely follicular lymphoma.
Claims 21, 22, 24, 25, 30, 31, 33, 34, 35, 40, 41, 43, 44, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, and 7 of U.S. Patent No. 12168016 (Cited in PTO-1449, herein referred to as ‘016) in view of Cheson et al. (Reference included with PTO-892).
Claims 1 and 3 of ‘016 claim a method of treating cancer comprising administering to a subject a compound having the same structure recited in present claims 21, 30, and 40. Claims 7 of ‘016 further specifies that the cancer is selected from a list including follicular lymphoma. Claim 4 of ‘016 further specifies that het compound is a hydrobromide salt.
The claims of ‘016 do not disclose methods further comprising administering rituximab and/or lenalidomide to the subject. However, Cheson et al. discloses that biologic agents such as rituximab are used to treat follicular lymphoma. (p. 306, introduction) Cheson further discloses the use of lenalidomide for treating follicular lymphoma, either alone or in combination with rituximab. (p. 308, “immunomodulatory drugs”)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapeutic method described in the claims of ‘016 in combination with lenalidomide and rituximab. One of ordinary skill in the art would have seen the prior art as suggesting administering all of these agents together in view of the fact that they are all disclosed as useful for treating the same condition, namely follicular lymphoma.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 9/29/2026
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