DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status
Claims 1-44 are pending. Claims 13, 15-18, 21-24, 34, and 36-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Claims 1-12, 14, 19, 20, 25-33, 35, and 40-44 and are under examination.
Election/Restrictions
Upon further review, it has been determined that daunorubicin and doxorubicin are not distinct species of each other and they will be grouped together as indistinct species.
Applicant’s election without traverse of:
1. acute myeloid leukemia (AML) as the cancer species,
2. tazemetostat as histone methyltransferase species,
3. daunorubicin/doxorubicin as chemotherapy species,
4. cytarabine as additional chemotherapy species, and
5. palbociclib as species of cell cycle inhibitor
in the reply filed on 7/28/2025 is acknowledged.
Claims 13, 15-18, 21-24, 34, and 36-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/28/2025.
Prosecution on the merits will be restricted to the claimed species if no generic claim is finally held to be allowable.
Priority
The present application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application 62/890,329, filed August 22, 2019.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 9/15/2022 has/have been considered by the Examiner. The submission(s) is/are in compliance with the provisions of 37 CFR §§ 1.97 and 1.98. Enclosed with this Office Action is a return-copy of the Forms PTO-1449 with the Examiner’s signature and indication of those references that have been considered.
Withdrawn Objection
Claims 6, 8, 10, and 44 were objected to but amendments to the claims remedied the issues described in the previous Office action. Therefore, the objection is hereby withdrawn.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Applicant amended Claims 1 and 28 to add the limitation “wherein the method reduces or relieves at least one clinical or subclinical symptom of the cancer” and argues that the limitation restricts the scope of claims 1 and 28 to the post-diagnosis treatment of an established cancer and excludes prophylactic use. This argument is not persuasive.
The amendment does not resolve the issue of prophylaxis/prevention issue nor does the amendment narrow the claims to the enabled invention, “AML cancer in a subject in need thereof with GSK126”.
The specification expressly defines “treatment” and “treating” to encompass prophylaxis. Specifically, the specification states:
“As used herein, the term ‘treatment’ or ‘treating’ encompasses prophylaxis and/or therapy. Accordingly, the compositions and methods of the present invention are not limited to therapeutic applications and can be used in prophylactic ones.”
The specification further defines “treating” to include: “(i) preventing or delaying the appearance of clinical symptoms of the state, disorder or condition developing in a subject that may be afflicted with or predisposed to the state, disorder or condition but does not yet experience or display clinical or subclinical symptoms.”
Applicant’s amendment adds the functional result limitation “reduces or relieves at least one clinical or subclinical symptom of the cancer.” However, this language was incorporated into the claim from prong (iii) of the specification’s definition of “treating” - “relieving the disease, i.e., causing regression of the state, disorder or condition or at least one of its clinical or subclinical symptoms. “The amendment therefore recites one prong of a 3-part definition whose remaining prongs – including explicit prophylactic use under prong (i) – remain part of the specification’s lexicography controlling claim construction/interpretation. Because the specification defines “treating” to encompass prophylaxis, and because the amended functional outcome limitation is consistent with and drawn from the same framework, the amendment does not exclude prophylactic use from the claim scope. A method that “reduces or relieves” a subclinical symptom in a subject predisposed to AML – as contemplated under prong (i) of the specification’s definition falls within the amended claim language when construed in light of the specification.
Separately from the above issue, the rejection is maintained because the amended claims still encompass a structurally diverse genus of actives: any histone methyltransferase inhibitor (HMi) combined with any chemotherapy for treating any cancer. The specification provides working examples for a narrow set of specific combinations – tazemostat, doxorubicin/daunorubicin, palbociclib and cytarabine – in AML. The claims however, are drawn to any HMi and any chemotherapy across all cancers elected and all subjects. The amendment does not narrow the actives or cancer to what was indicated as being enabled by the rejection.
Therefore, the rejection is deemed to still be proper and is, therefore, maintained.
Claim Rejections - 35 USC § 112
Maintained
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12, 14, 19, 20, 25-33, 35, and 40-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for relieving AML cancer in a subject in need thereof with GSK126, does not reasonably provide enablement for “treating” (as defined in the specification) AML in a subject with any histone methyltransferase inhibitor (HMi) such as a EZH2 inhibitor (EZH2i). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The test of enablement requires a determination of whether the disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
Claim 1 broadly recites:
“a method of treating a cancer (AML elected) with any HMi (such as any EZH2i)”
Thus, the claims are broadly drawn to treating – defined to encompass prophylaxis and preventing –(see specification at p. 15:32 to pg. 16:4) – cancer, such as AML, by implementing a chemotherapeutic strategy to a subject. This is despite the lack of sufficient support for prevention/prophylaxis of any single cancer whether in vitro or especially in vivo.
The nature of the invention:
The invention relates to the elected invention of a method of treating AML using a combination of tazemostat, doxorubicin/daunorubicin, palbociclib and cytarabine. Treatment is defined broadly to include not only therapeutic intervention, but also prophylaxis and prevention, i.e., inhibiting or stopping cancer before it arises.
Breadth of claim:
The breadth of the claims is extremely wide but the claims and specification purport to cover prophylaxis/prevention of the cancer with any HMi/EZH2i. By contrast, no evidence is provided that prevention or prophylaxis had been achieved in a subject.
State and predictability of the art:
The state of the art of oncological drug development is recognized as being complex. Furthermore, the state of the art recognizes that AML cannot be prevented. For example, the Care at Cleveland Clinic (“Acute Myeloid Leukemia (AML).” https://my.clevelandclinic.org/health/diseases/6212-acute-myeloid-leukemia-aml#management-and-treatment) reference states explicitly “[n]o, you can’t prevent acute myeloid leukemia. Experts know that genetic mutations cause acute myeloid leukemia but they don’t know what triggers them. They do know about risk factors that may cause AML.” See p. 14. It further teaches that treatments may include chemotherapy, targeted therapy (including monoclonal antibody therapy) or allogeneic stem cell transplantation. The goal is to put AML into complete remission. In AML, complete remission means tests show your blood counts are normal. There are three phases to chemotherapy for AML — induction, consolidation and maintenance. See p. 9. All cancer treatments have side effects. In AML, stem cell transplantation has the most serious side effects. Chemotherapy may cause myelosuppression, when you don’t have the normal number of blood cells and platelets. Targeted therapy side effects vary based on the specific drugs used. Understanding side effects is an important part of knowing how cancer treatment will affect your daily life. Your healthcare provider is your best resource of information about specific treatment side effects. Some people may benefit from palliative care to help manage side effects. See p. 10. While patients may obtain complete remission, it may only last for months or years, not prevented.
Furthermore, a decrease or deficiency in HMi/EZH2i is actually known to exacerbate AML. See (Tazverik (tazemetostat). https://reference.medscape.com/drug/tazverik-tazemetostat-1000089#0), which teaches that AML can be exacerbated when administered tazemostat.
Relative skill level:
One of ordinary skill in the art is one with access to reagents, tools and equipment used for diagnosing disease, performing tests and/or administering treatment to individuals. The skilled artisan also has many years of training and experience in either the clinical or laboratory environment or both. Therefore, it is clear that the level of skill of one in the art is high. However, this high level of skill is overcome in view of the limited teachings provided by the specification and the unpredictable state of the art, it would require the skilled artisan undue experimentation to make and use the invention commensurate to the scope of the claims.
The amount of direction or guidance provided and the presence or absence of working examples:
The specification fails to provide any guidance or evidence on how to “treat prophylactically” or “prevent” the claimed disease. It does not provide any working examples showing effective prevention or prophylaxis in a single disease, less AML.
The quantity of experimentation necessary:
Because of the known unpredictability of the art, and in the absence of experimental evidence demonstrating prevention or prophylaxis, no one skilled in the art would accept the assertion that the instantly claimed agents could be “treat” (as defined on the specification) a cancer such as AML mentioned in the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
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, James H. Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRIS E. SIMMONS
Examiner
Art Unit 1622
/CHRIS E SIMMONS/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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