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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/16/2025 has been entered.
Claim Rejections - 35 USC § 103, MAINTAINED
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 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 1, 8 and 10-18 remain rejected under 35 U.S.C. 103 as being unpatentable over CN 106822099 A (whose English language machine translation has been relied upon for purposes of this Office Action).
Inventor teaches a method for modulating a lipid raft integrity of a cell, comprising administering a pharmaceutical composition to a subject, in need of treatment for modulating lipid raft integrity, wherein the pharmaceutical composition comprises a benzene sulfonamide derivative, which is para-toluene sulfonamide, that serves as a cholesterol-depleting agent, and a pharmaceutically acceptable excipient thereof, and wherein the method treats diseases susceptible to amelioration by a decreased level of the lipid raft integrity, wherein the disease is cancer, and wherein the cancer expresses lipid raft markers and is at least one selected from the group consisting of prostate cancer, kidney cancer, bladder cancer, seminoma, ovarian cancer, cervical cancer, colon cancer, thyroid cancer, meningiomas, bile duct cancer, and vulvar cancer (independent claim 1).
Inventor also teaches a method of treating cancer comprising administering a pharmaceutical composition to a subject in need thereof wherein the composition comprises a benzenesulfonamide derivative, which is para-toluene sulfonamide, that serves as a cholesterol-depleting agent, and a pharmaceutically acceptable excipient and wherein the cancer is susceptible to amelioration by a decreased level of the lipid raft integrity and wherein the cancer expresses lipid raft markers and is at least one selected from the group consisting of prostate cancer, kidney cancer, bladder cancer, seminoma, ovarian cancer, cervical cancer, colon cancer, thyroid cancer, meningiomas, bile duct cancer, and vulvar cancer (independent claim 8). Dependent claim 10 teaches that the method further comprises administering at least one additional anti-cancer therapy. Dependent claim 11 teaches that the additional anti-cancer therapy is whole body, chemotherapy, radiotherapy, or thermal therapy. Dependent claim 12 teaches that the benzene sulfonamide is administered in an amount of about 20 mg to about 4000 mg per day. Dependent claim 13 teaches that the composition modulates lipid raft integrity of a cancer cell. Dependent claim 14 teaches that the composition depletes cholesterol from plasma membrane of the cancer cell. Dependent claim 15 teaches that the composition disturbs or disrupts the lipid raft integrity of the cancer cell.
Finally, inventor teaches a method for treating a subject suffering from prostate cancer, kidney cancer, bladder cancer, seminoma, ovarian cancer, cervical cancer, thyroid cancer, meningiomas, bile duct cancer, or vulvar cancer, comprising administering to the subject an effective amount of a pharmaceutical composition that comprises para-toluene sulfonamide, and a pharmaceutically acceptable excipient, that serves as a cholesterol-depleting agent (independent claim 16). Dependent claim 17 teaches administering at least one additional anti-cancer therapy. Dependent claim 18 teaches that the subject is suffering from prostate cancer.
CN 106822099 A teaches an injectable pharmaceutical composition of Vitamin C and a benzene sulfonamide utilized in the treatment of malignant tumors for patients whose tumors cannot be surgically resected (abstract). P-toluenesulfonamide (para-toluene sulfonamide) is explicitly taught as one of the benzene sulfonamides (Specification Eng. Trans. Page 4, compound 4). Furthermore, the reference teaches that the composition has a good anti-tumor effect for other malignancies including, but not limited to: melanoma, stomach cancer, lung cancer, breast cancer, kidney cancer liver cancer, oral epidermal cancer, cervical cancer, ovarian cancer, pancreatic cancer, prostate cancer, colon cancer, bladder cancer, brain tumor, esophageal cancer, lymphoma, nervous system cancer and other tumors (Specification Eng. Trans. beginning at last paragraph on page 7).
As inventor correctly notes in the specification, it is known in art that “[l]ipid rafts, which are membrane microdomains, preferentially associate with cholesterol, saturated lipids and kinases in regulating a number of cell signaling pathways.” Inventor also correctly notes that it is known in the art that depletion of cholesterol from plasma membranes is capable of disrupting PI3K/Akt signal transduction, which suggests the importance of cholesterol content in lipid raft integrity. Furthermore, as inventor correctly notes, it is known in the art that breast and prostate cancer cells, for instance, are more abundant in lipid rafts, which leads to their higher susceptibility to apoptotic stimuli caused by cholesterol depletion. Finally, as inventor correctly notes, it is known in the art that some cancers (explicitly: prostate, lung, pancreas, melanoma, kidney, bladder, seminoma, ovarian, cervical, breast, colon, liver, esophageal, oral, tongue, thyroid, meningiomas, bile duct, hypopharyngeal, nasopharyngeal, gastric and vulvar) show increased expression of lipid raft markers (specification page 2, line 15 to page 3, line 6).
Inventor distinguishes over the prior art methods essentially in specifying a particular mechanism by which the administered composition must function i.e. the benzenesulfonamide serves as a cholesterol-depleting agent wherein the cancer is susceptible to amelioration by a decreased level of lipid raft integrity (claims 1 and 8), and by explicitly stating desired results i.e. modulating lipid raft integrity (claim 1), modulating lipid raft integrity of a cancer cell (claim 13), depleting cholesterol from plasma membrane of a cancer cell (claim 14), disturbing or disrupting the lipid raft integrity of a cancer cell (claim 15), and a cholesterol-depleting agent (claims 16-18). However, the actual step of the prior art method is identical to that of the instant invention: administering a pharmaceutical composition comprising a benzenesulfonamide derivative and a pharmaceutically acceptable excipient. Furthermore, the reason for carrying out the step of administering is also identical: the treatment of cancer (i.e. the treatment of cancers susceptible to amelioration by a decreased level of lipid raft integrity such as prostate, lung, pancreas, melanoma, kidney, bladder, seminoma, ovarian, cervical, breast, colon, liver, esophageal, oral, tongue, thyroid, meningiomas, bile duct, hypopharyngeal, nasopharyngeal and vulvar vide supra). Finally, the prior art method is a successful method of treating cancer, particularly for patients whose tumor cannot be surgically resected.
Note that an obviousness rejection is proper when the prior art suggest a reason or provides motivation to make the claimed invention, even where the reason or motivation is based on a different motivation from that of applicant. It is not necessary in order to establish a prima facie case of obviousness that there be a suggestion or expectation from the prior art that the claimed invention will have the same or similar utility as the one newly discovered by applicant. (See MPEP 2144 (IV).)
In sum, simply claiming the desired mechanism by which the prior art composition employed in the prior art method successfully treats the cancer does not distinguish over that prior art method. Nor does explicitly stating the desired results of administration of the composition. For both the prior art method and the instant method, with respect to the elected species: the method step is the same, the composition is the same (comprises the same component), the patient population is the same, the reason for administering the composition is the same, and the result is the same.
Claims 10 and 11 are included in the rejection because one of ordinary skill in the art, i.e. an experienced clinical oncologist; a highly skilled individual, would have found it obvious to administer additional anti-cancer therapies, such as chemotherapy, radiotherapy, etc., to a patient suffering from cancer if in his or her professional judgement the patient might benefit from such additional treatment. There is nothing unusual or inventive in such combination therapies in the medicinal arts.
Claim 12 is included in the rejection because one of ordinary skill in the art, i.e. an experienced clinical oncologist; a highly skilled individual, would have found it obvious to optimize the dosage of para-toluene sulfonamide expressed in mg in order to achieve a desired clinical result (in this case, the treatment of cancer). This is part and parcel of the clinician’s professional desire to effectively treat the cancer guided by ordinary clinical considerations (efficacy, route of administration, patient compliance/tolerance, etc.).
In the latest amendment, inventor has deleted the limitations pancreas cancer and hypopharyngeal cancer from the independent claims. Inventor asserts that “…the Examiner indicates that the mechanism of the administered composition cannot be regarded as a distinguishable feature for the claimed invention of the present application for the prior art, and CN 106822099 A provides reasonable motivation to select specific cancers, in particular, pancreatic cancer or esophageal cancer [emphasis in the original], as treating targets.”
The examiner respectfully points out that the first part of inventor’s assertion - that the elucidation of the mechanism of the administered composition cannot be regarded as a distinguishable feature - is correct. The second part of inventor’s assertion, however - which focuses on pancreatic cancer or esophageal cancer - is not correct. There is, in fact, no such focus on pancreatic cancer or esophageal cancer, in particular, in the outstanding rejection. Simply deleting these two cancers as claim limitations from the independent claims does not alter the scope of the claimed subject matter such that the rejection is overcome.
Inventor argues that the instant inventors have discovered the cause of inconsistent para-toluene sulfonamide treatment efficacy against cancer and that such a discovery solves an unmet medical need to fight against multiple adaptive mechanisms of cancer cells. The examiner respectfully points out, however, as has been pointed out above and in previous Office Actions, that discovering the cause of why a prior art method is efficacious does not impart a patentable distinction over that prior art method.
Inventor further argues that CN 106822099 A only mentions pancreas cancer and hypopharyngeal cancer but fails to provide any reasonable motivation for a person skilled in the art to modify the target cancers beyond these two. The examiner respectfully disagrees. Inventor’s interpretation of the teachings of CN 106822099 A is not a fair interpretation of what the reference clearly and explicitly teaches (as outlined above).
In sum, the examiner respectfully, again, points out that an obviousness rejection is proper when the prior art suggest a reason or provides motivation to make the claimed invention, even where the reason or motivation is based on a different motivation from that of applicant. It is not necessary in order to establish a prima facie case of obviousness that there be a suggestion or expectation from the prior art that the claimed invention will have the same or similar utility as the one newly discovered by applicant. (See MPEP 2144 (IV).) Simply claiming the desired mechanism by which the prior art composition employed in the prior art method successfully treats the cancer does not distinguish over that prior art method.
All claims remain rejected.
Markush Search
All claims, after amendments during prosecution, are limited to the single species: para-toluene sulfonamide.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EST.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 1/9/2026