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 .
Election/Restrictions
Applicant’s election without traverse of claims 3, 5, and 24 in the reply filed on March 16, 2026 is acknowledged.
Status of Claims
Claims 2-3, 5, 7, 9, 11, 13, 15-22, 24, and 26-30 are currently pending in the instant application. Claims 7, 9, 11, 13, 15-24, and 26-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 2-3, 5, and 24 are under examination on the merits in the instant application.
Drawings
The drawings are objected to because the letters, labels, and/or numbers in Figures 2E, 3F, 3G, 3H, 3I, 3J, 4F, 5A-5I, 6A-6I, 7A-7F, 8E, and 9 are not clearly legible. In addition, Figure 5A appears to contain a drawing, which is completely illegible. 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 - Improper Markush Grouping
Claims 2-3, 5, and 24 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination of process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP §706.03(y).
The Markush grouping of an ISR overrider, an ISR inhibitor, an ADAR inhibitor, a PKC inhibitor, a PARP inhibitor, a METTL3 inhibitor, and a one-carbon metabolism inhibitor recited in claim 2 and all dependent claims thereof is improper because the alternatives defined by the Markush grouping do not share a common single structural similarity. For instance, as evidenced by the pending claims in the instant application, an ISR overrider comprises trazodone, which shares no structural similarity with 8-azaadenosine that is an ADAR inhibitor. Hence, all alternatives in the group recited in (i) do not all share a single structural similarity, nor do all alternatives share a common use flowing from a substantially shared structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternatives within a single claim in fact share a single structural similarity as well as a common use.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2-3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oren et al. (WO 2009/016488 A2, applicant’s citation).
Oren discloses a pharmaceutical “combination” composition for treating cancer comprising a therapeutically effective amount of “trazodone” in combination with a secondary anti-cancer therapeutic agent such as “Taxol”, “paclitaxel”, “gemcitabine”, and “doxorubicin”. See claims 39-46 and 49; paragraphs 0042, 0088, and 0092.
Accordingly, claims 2-3 and 5 are described by Oren et al.
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.
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 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. (International Journal of Oncology, 1992, 1:735-742).
Fan teaches that trazodone provides cytotoxic effects in cancer cells and that trazodone enhances cytotoxicity of a chemotherapeutic drug such as adriamycin (ADR) such that “trazodone enhanced the cytotoxicity of ADR by approximately ten fold”. See page 741; Tables I-II.
Although Fan does not disclose a single combination composition comprising trazodone and a chemotherapeutic drug, it would have been obvious to one of ordinary skill in the art before the effective filing date to make such single combination composition. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to make a more effective anti-cancer agent than each agent alone because the combined anti-cancer effects provided by both trazodone and ADR were known in the art as taught by Fan.
Accordingly, claims 2 and 5 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 2-3, 5, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Oren et al. (WO 2009/016488 A2, applicant’s citation) in view of Li et al. (US 2022/0152101 A1).
Oren discloses a pharmaceutical “combination” composition for treating cancer comprising a therapeutically effective amount of “trazodone” in combination with a secondary anti-cancer therapeutic agent such as “Taxol”, “paclitaxel”, “gemcitabine”, and “doxorubicin”. See claims 39-46 and 49; paragraphs 0042, 0088, and 0092.
Oren does not teach that the “combination” composition comprising trazodone and gemcitabine further comprises immune cells.
Li teaches “the combination of Gemcitabine and tumor antigen-targeted immune cell therapy can significantly improve the anti-tumor effect, and even achieve the therapeutic effect of complete remission.” See paragraph 0044. See also claim 31 claiming a combination medicament, wherein “the medicament comprises the [immune effector] cell and Gemcitabine”, wherein the medicament is “formulated to provide a greater therapeutic effect than the sum of the effects of each of the cell and Gemcitabine when used alone.”
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Oren’s combination pharmaceutical composition by further including immune effector cells. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to further enhance anti-cancer therapy effects by the combination composition because a therapeutic composition comprising both the immune effector, antigen-targeted immune cells and a chemotherapeutic agent such as gemcitabine was known to provide superior or synergistic anti-cancer effects compared to each agent alone as disclosed by Li. That is, one of ordinary skill in the art would have readily and reasonably deemed that the addition/inclusion of the anti-cancer immune cells in Oren’s combination composition would be beneficial in greatly or significantly enhancing the intended anti-cancer effects of Oren’s composition in view of the teachings of Li thus would have been motivated to further include the anti-cancer immune cells in Oren’s combination composition, thereby arriving at the instantly claimed subject matter.
Accordingly, claims 2-3, 5, and 24 taken as a whole would have been prima facie obvious before the effective filing date.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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