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 .
Response to Amendment
Applicant’s response of 08/05/2025 has been received and entered into the application file. Claims 37-54 are pending in this application.
Claim Rejections - 35 USC § 103
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.
Claims 37-54 are rejected under 35 U.S.C. 103 as being unpatentable over Weissbach et al. (WO 2006/102439 A2).
Weissbach discloses compositions comprising sulindac and other oxidating agents that generates reactive oxygen species (ROS), significantly enhancing the killing of cancer cells (Abstract). Cancer refers to all types of cancer or neoplasm or malignant tumors found in mammals ([0058]). The oxidizing agent comprises at least one of sodium peroxyborate tetrahydrate (sodium perborate tetrahydrate) ([0013]). Therapeutic agents can include, for example, chemotherapeutic agents such as cyclophosphamide, taxanes, busulfan, cisplatin, methotrexate, doxorubicin, and others ([0120]). The appropriate doses of chemotherapeutic agents will be generally around those already employed in clinical therapies ([0121]). The composition can contain conventional nontoxic pharmaceutically acceptable carriers, adjuvants, and vehicles as desired ([0138]).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined a chemotherapeutic drug with perborate salt for treatment of cancer. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claims 38-39, sodium perborate salt is discussed above.
Regarding claims 40-41, Weissbach discloses lung cancer ([0059]).
Regarding claim 42, Weissbach discloses a composition comprising perborate salt for treatment of cancer as discussed above. One of ordinary skill in the art would expect a composition comprising an oxidizing agent such as perborate salt would help eliminate cancer cells as taught by Weissbach.
Regarding claim 43, sodium perborate salt is discussed above.
Regarding claim 44, sodium perborate tetrahydrate’s formula is NaBO3 * 4 H2O.
Regarding claim 45, chemotherapy agent is discussed above.
Regarding claim 46, perborate salt would generate reactive oxygen species which would enhance the cancer cell elimination as discussed above. Weissbach teaches a method of treating cancer, said method comprising administering to a cancer cell a pharmaceutical composition comprising sulindac and an oxidizing agent ([0026]).
Regarding claim 47, Weissbach discloses that all cancers are included as discussed above.
Regarding claim 48, Weissbach discloses lung cancer ([0059]).
Regarding claim 49, sodium perborate salt is discussed above.
Regarding claim 50, perborate salt formula is discussed above.
Regarding claim 51, one of ordinary skill in the art would routinely experiment with varying concentrations of perborate salt within a pharmaceutical composition.
Regarding claim 52, the chemotherapy agent is discussed above.
Regarding claim 53, Weissbach discloses a perborate salt composition for treatment of various cancer cells as discussed above. Weissbach teaches a method of treating cancer, said method comprising administering to a cancer cell a pharmaceutical composition comprising sulindac and an oxidizing agent ([0026]).
Regarding claim 54, chemotherapy agent is discussed above.
Response to Arguments
Applicant’s arguments filed 08/05/2025 have been fully considered but they are not persuasive.
The definition of an anticancer drug is a general term for any medicine used to treat cancer, including chemotherapy. A chemotherapeutic drug would have, in some capacity, anticancer activity. Therefore, the examiner cannot understand the distinction emphasized in the claim language.
On page 7 of remarks, applicant argues that the entirety of Weissbach is drawn to compositions comprising sulindac. Applicant argues that sulindac is an anti-cancer agent but it is not a chemotherapy agent. Therefore, sulindac and the combinations described in Weissbach are excluded from the scope of the present claims.
Weissbach indeed discloses compositions comprising sulindac and other oxidating agents that generate reactive oxygen species such as sodium peroxyborate tetrahydrate (sodium perborate tetrahydrate) ([0013]). However, as evidenced by Li et al. (Sulindac sulfide inhibits colon cancer cell growth and downregulates specificity protein transcription factors, BMC Cancer, 2015), sulindac has chemotherapeutic effects; sulindac and its metabolites inhibited RKO and SW480 colon cancer cell growth (Abstract). It has been reported that sulindac and its’ metabolites exhibit growth inhibitory activity and this is associated, in part, not only with downregulation of surviving but also decreased expression of the epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) (pg 2, left col). A composition taught by Weissbach includes a perborate salt and sulindac, which has chemotherapeutic effects as evidenced above.
Per MPEP 2145 (II), Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Weissbach teaches a composition comprising sulindac and a perborate salt focused on killing cancer cells. Sulindac with a perborate salt would have decreased the gene expression of EGFR. Therefore, claims remain rejected.
Conclusion
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 JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615