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 .
Priority
The instant application is a 35 USC 371 National Stage filing of international application No. PCT/CN2021/102606, filed June 28, 2021, which claims foreign priority under 35 USC 119(a)-(d) from Chinese application CN 202010812329.3, filed August 13, 2020.
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 February 13, 2023 was in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS document was considered and a signed copy of the 1449 form is attached.
Status of Claims
Currently, claims 2-4 and 6-8 are pending in the instant application and are under consideration herein.
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 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.
With respect to all rejections herein, the following is noted regarding the interpretation of the claim scope. Instant claims 2-4 and 6-8 just require a single active step of administration of the recited compound or derivative thereof to a subject. Subjects having Type 1 diabetes are considered to be “a subject in need thereof” in the context of the present invention, such that claims reciting an effect of that anticipatory administration (for example improving pancreatic islet function, improving insulitis, reducing infiltration of mononuclear cells or inhibiting STAT4 activation) are necessarily also anticipated.
Claim(s) 2-4 and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zeng et al. Diabetes 2021; 70 (Supplement 1): 113-OR.
The prior art teaches the use of sorafenib in the preparation of an oral medicine for the treatment of type 1 diabetes. The reference specifies that for type 1 diabetic patients, sorafenib provides an oral drug therapy to the patient (Abstract). The prior art teaches the administration of sorafenib to NOD (non-obese diabetic) mice impeded the development of T1D and ameliorated insulitis, which coincided with a specifically decreased aggregate of Th1 cell population in pancreas but not in peripheral immune organs. Further, sorafenib administration inhibits the development of T1D by suppressing IL-12b/JAK2/STAT4 signaling-mediated Th1 cell differentiation specifically in pancreas in NOD mice. Finally, sorafenib is disclosed as a “promising therapeutic” for T1D in humans. Accordingly, since the prior art teaches all required limitations of the claimed invention, the claims are anticipated.
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 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 2-4 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. and Rongrong et al. (each cited in 2/13/2023 IDS)
The instant claims are drawn to a method for preventing and/or treating type 1 diabetes, comprising administering sorafenib or a derivative thereof to a subject in need thereof.
Determining the scope and contents of the prior art
Lin et al. discloses that sorafenib is known to inhibit the production of IL-12 in a dose-dependent manner (page 795, Fig. 4b).
Ascertaining the differences between the prior art and the claims at issue
The difference between the instant invention and the prior art is that the primary reference does not specify that sorafenib is administered to treat or prevent type 1 diabetes (T1D), or to improve pancreatic islet function in T1D, or to inhibit STAT4 activation. It is reiterated herein that the only active step in claim 6 is the inhibition of an enzyme activation, which would necessarily occur upon carrying out the only required active step (namely, administration of sorafenib, for any condition).
Resolving the level of ordinary skill in the pertinent art
However, this deficiency in the disclosure of Lin et al. would have been known to a person of ordinary skill in the art upon combination with the other cited references above.
With respect to this difference, MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. 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."
MPEP 2144(II) states that the strongest rationale for the combining of references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning…that some advantage or expected beneficial result would have been produced by their combination. See In re Sernaker, 702 F.2d 989, 994-95 217 USPQ 1, 5-6 (Fed. Cir. 1983). See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1468, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006). (“Indeed, we have repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the improvement is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves.”).
With respect to the difference between Lin et al. and the instantly claimed invention, the person of ordinary skill would look to Rongrong et al. for its teaching the IL-12 (the same enzyme referenced in Lin et al.) promotes the differentiation of CD4+ T cells into Th1 cells. Further, during the pathogenesis of Type 1 diabetes, Th1 cells are increase, and islet B cells are destroyed by secreting TH1 type cytokines, while Th2 cells (which antagonize the effect of TH1 cells) are decreased or reduced in function. Therefore, Th1 cells/Th2 cells are out of balance,and Th1 cells dominate, such that islet B cells are further reduced which exacerbates Type 1 diabetes. Since Islet B cells are disclosed in the art as being directly damaged by IL-12, it is clear that IL-12 can promote the pathogenesis of Type 1 diabetes (page 1051, right column, section 3.2). The art recognizes IL-12 as directly promoting pathogenesis of Type 1 diabetes, it would have been obvious to a person of ordinary skill in the art to administer a medicinal substance which is known to mitigate the IL-12 interaction. Accordingly, it would have been obvious to use the known treatment IL-12 inhibitor in sorafenib, as disclosed by Lin et al. for the treatment of Type 1 diabetes.
Accordingly, the instant invention would have been prima facie obvious at the time the invention was filed since the differences between the instantly claimed invention and the prior art amount to using a known treatment (sorafenib) to inhibit a pathway known to contribute to the pathogenesis of type 1 diabetes, as disclosed by Rongrong et al. There is no evidence that the instantly claimed compounds possess any properties which would render it unexpectedly superior for patients having type 1 diabetes, since the combination of art provides at least a reasonable suggestion that sorafenib would function in this therapeutic role. As such, the instant claims are held to be obvious over the teachings of Lin et al. and Rongrong et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699