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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/13/2026 has been entered.
Upon entry of the amendment, claims 1, 2, 9, 18, 35 are pending and under consideration.
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 1, 2, 9, 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20060009506 (hereinafter “Westwick”).
Regarding claim 1, Westwick teaches a method comprising contacting a pancreatic cell with an inhibitor wherein the inhibitor is the antidepressant sertraline (also known as Zoloft) (e.g., see Figure 2). Westwick teaches that treating the pancreatic cells has an antiproliferative effect on the pancreatic cells (see Figure 2). Since Westwick teaches a method comprising all of the required method steps, the method taught by Westwick would necessarily have the same results as the claimed method including inhibiting SLC38A2. It is noted that Westwick also explicitly teaches treating a mammal patient having a neoplasm, said method comprising administering an effective amount of sertraline (see claim 1), and further teaches treatment in conjunction with an additional treatment that can be surgery (see claim 6).
Regarding claim 2, Westwick teaches that the pancreatic cells are MiaPaCa cells (e.g., see Figure 2. It is noted that MiaPaCa cells are pancreatic cancer cells.
Regarding claim 9, Westwick teaches that 1uM of sertraline is administered to the MiaPaCa cells, which is well within the range of 1nM to 100mM required by claim 9.
Regarding claim 35, Westwick teaches that the pancreatic cells are MiaPaCa pancreatic cancer cells (e.g., see Figure 2), which are pancreatic ductal adenocarcinoma cells – official notice is taken, if necessary.
Therefore, Westwick anticipates claims 1-2, 9, 35.
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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over by US 20060009506 (hereinafter “Westwick”) as applied in the rejection above, in view of Passik and Roth Psycho-oncology 8: 268-272; 1999 (hereafter “Passik” – of record).
As indicated in the rejection above, Westwick teaches treating pancreatic cancer cells with sertraline, and also teaches treating a mammal patient having a neoplasm, said method comprising administering an effective amount of sertraline (see claim 1), and further teaches treatment in conjunction with an additional treatment that can be surgery (see claim 6).
Westwick does not teach explicitly teach that the method is used in combination with resection of a pancreatic tumor, as required by claim 18.
However, since Westwick teaches a combination treatment that includes surgery, it would have been prima facie obvious to one of ordinary skill in the art prior to the day the claimed invention was filed to treat a pancreatic cancer in a subject with sertraline in combination with surgery that is resection of the pancreatic tumor, with a reasonable expectation of success. Since Westwick teach treating pancreatic cancer with sertraline and also teaches that the cancer treatment can be in combination with surgery, one of ordinary skill in the art would recognize that the surgery would be resection of the pancreatic tumor. There would have been a reasonable expectation of success based on the positive results demonstrated by Westwick.
Additionally, it is also noted that resection of eligible pancreatic tumors was well known in the prior art. For instance, Passik teaches that depression and anxiety occur more frequently in cancer of the pancreas than in other forms of intra-abdominal malignancies and other cancers in general, and further reports a patient who present panic attacks prior to pancreatic cancer diagnosis and whose symptoms resolved following resection of the tumor (e.g., see abstract, page 269 first paragraph, etc.).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the day the claimed invention was filed to combine sertraline treatment with resection of a pancreatic tumor in an animal who suffers from depression/anxiety/panic attacks and who also has a pancreatic tumor, with a reasonable expectation of success. The motivation to combine is based on the fact that sertraline was a known antidepressant and resection of pancreatic tumors in a patient that has panic attacks, not simply anxiety, was also known. There would have been a reasonable expectation of success based on the positive results reported in the prior art. It is also noted that it would have been a matter or combining known treatments for treating pancreatic cancer: sertraline and pancreatic tumor resection.
Therefore, the instant claims are unpatentable over Westwick and Passick.
The combination of prior art satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 USPQ2d 1385 (2007):
“Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) 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.”
Response to Arguments
With respect to the rejection of claims under 35 USC 102 and 35 USC 103 as set forth in the previous office action, Applicant’s arguments have been fully considered and in view of the amendment to the claims deleting “fluoxetine” from the claim are persuasive. Therefore, the rejection has been withdrawn. However, upon further search and consideration, a new ground(s) of rejection is made in view of Westwick for the reasons indicated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637
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