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 .
DETAILED ACTION
Claims 1-6 are pending in the instant application.
Claims 1-6 are examined herein.
Priority
The instant application claims priority from Korea Patent Application No. 10-2024-0091599, filed on 11 July 2024.
A certified copy of the priority document, in Korean, was submitted on 13 February 2025.
Should Applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 January 2025 is acknowledged and considered.
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, 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rios Perez et al. (Surgeon Open Science 2019, 1, 56-63, cited in PTO-892).
Rios Perez teaches (Abstract) that auranofin is a therapeutic agent with anticancer properties for lung and ovarian cancer.
Rios Perez teaches (Figure 4) a method of treating a neoplastic disorder which is pancreatic cancer in a subject in need thereof comprising administering to the subject a composition containing auranofin, as in instant claim 1.
Rios Perez teaches that administering auranofin 15 mg/kg, which is within the range in instant claim 5, to a subject suffering from pancreatic cancer (nude mice with MiaPaCa-2 tumors), where auranofin is administered 5 times a week (Monday to Friday once a day), as in instant claim 6, as a solution (page 59, right column) at a concentration of 1.25 mg/mL (300 mL solution corresponding to 15 mg/kg, auranofin solutions calculated based on 25 g mouse, thus 15 mg/kg x 25 g= 0.375 mg auranofin in 300 mL solution = 1.25 mg/mL), as in instant claim 4, results in lower tumor burdens and prolonged survival.
As such, a method of instant claims 1, 4-6 is anticipated by Rios Perez.
Claims 1-3, 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drug repositioning for VS treatment (Memorial Symposium pamphlet, Korea, 13 January 2024, cited in IDS).
Drug repositioning for VS treatment teaches (page 40 of 43) a method of treating VS(2) neurofibromatosis type 2 and associated vestibular schwannoma (a neoplastic disease of instant claims 1-3) in a subject in need thereof by administering to the subject compound C1 (which is auranofin, see instant Specification, page 10, Table 1, [0052]) at a dose of 2 mg/kg, or 10 mg/kg (graph is the same as instant Fig. 5C), as in instant claim 5, with reduction in tumor size (Figure is the same as instant Fig. 5B).
As such, a method of instant claims 1-3, 5 is anticipated by Drug repositioning for VS treatment.
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.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (European Journal of Pharmacology 2014, 740, 240-247, cited in PTO-892), in view of Plotkin et al. (N Engl J Med 2009, 361 (4), 358-367, cited in PTO-892).
He et al. (European Journal of Pharmacology 2014, 740, 240-247) teach that auranofin (Abstract) is an anti-angiogenic compound (page 242-243, points 3.3 and 3.4) in vitro and in vivo. He teaches (page 240, right column, first paragraph) that inhibition of angiogenesis is a vital target for cancer therapy.
He teaches that auranofin suppressed the vascular endothelial growth factor (VEGF) signaling pathway (Abstract, also point 3.5), and inhibited the phosphorylation of vascular endothelial growth factor 2 (p-VEGFR2).
He teaches (page 246, right column, under Conclusions) that auranofin inhibits angiogenesis due to the inhibition of VEGF signaling pathway.
He also teaches (Figure 1 B-E) that auranofin inhibited the proliferation of cancer cells HepG2 (liver cancer), MCF-7 (breast cancer), A2780 (Ovarian cancer) and A549 (lung cancer), which are human cancer lines, in a dose dependent manner, with IC50 between 0.607 and 5.41 mM.
He does not teach a method of treating a neoplastic disorder which is neurofibromatosis type 2 or vestibular schwannoma, with auranofin, as in instant claims 2-3.
He does not teach the dose of auranofin administered, the concentration of the composition comprising auranofin, or the frequency of administration of auranofin in the method of treatment, as in instant claims 4-6.
Plotkin et al. (N Engl J Med 2009, 361 (4), 358-367) teach that anti-VEGF therapy is effective to treat neurofibromatosis type 2 and associated vestibular schwannoma in a subject in need thereof.
Plotkin teaches that neurofibromatosis type 2 is a genetic condition associated with bilateral vestibular schwannomas, which are benign tumors that arise from the eighth cranial nerve (page 358, under Background).
Plotkin teaches that VEGF is expressed in 100% of vestibular schwannomas and VEGFR-2 in 32% of tumor vessels (page 358, under Results).
Plotkin teaches (page 241, left column, third paragraph) that VEGF is a critical mediator of tumor angiogenesis, and VEGF has been detected in schwannomas, and increased levels of VEGF correlate with increased rates of tumor growth.
Plotkin teaches (page 358, last three lines) that VEGF blockade with bevacizumab was associated with a reduction in the volume of most growing vestibular schwannomas in patients with neurofibromatosis type 2.
It would have been obvious to a person of ordinary skill in the art to combine the teachings of He and Plotkin to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to administer auranofin to a subject suffering from neurofibromatosis type 2 associated with vestibular schwannomas, because He teaches that auranofin inhibits VEGF signaling pathway, Plotkin teaches that VEGF has been detected in schwannomas, and increased levels of VEGF correlate with increased rates of tumor growth, and Plotkin teaches that anti-VEGF therapy is effective to treat neurofibromatosis type 2 and associated vestibular schwannoma in a subject in need thereof. Thus, the person of ordinary skill in the art would have administered a VEGF inhibitor auranofin to a patient suffering from neurofibromatosis type 2 and associated vestibular schwannoma, with a reasonable expectation that inhibition of VEGF signaling by auranofin will result in therapeutic effect/treatment.
Regarding claim 4, the person of ordinary skill in the art would have determined the optimal concentration of auranofin in a composition to be administered in the method of treatment, and regarding claims 5, 6, the person of ordinary skill in the art would have determined the therapeutic dose and the frequency of administration, because such determination of therapeutic dose and frequency of administration in order to optimize therapeutic effect in a method of treatment, is well within the skill of the artisan.
As such, claims 1-6 are rejected as prima facie obvious.
Conclusion
Claims 1-6 are rejected.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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