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 .
Status of Claims
Currently, claims 2 and 7-9 are pending in the instant application and are under consideration herein, with claim 9 being newly added.
Response to Arguments and Amendments
Applicant’s arguments and amendments filed May 5, 2026 have been entered. All rejections and objections not explicitly maintained herein are withdrawn. The rejections below constitute the full set of rejections being applied to the instant claims.
With respect to the rejection of claims 2-4 and 6-8 under 35 USC 102(a)(1), the rejection is withdrawn in view of the submission of a certified copy of the foreign priority document. Accordingly, the instant claims are now examined with an effective filing date of August 13, 2020. Zeng et al. no longer qualifies as prior art over the instant claims.
With respect to the rejection of claims 2-4 and 6-8 (now 2 and 7-9) under 35 USC 103, Applicants traverse the rejection on several grounds, each of which has been considered but was not found to be persuasive.
First, Applicants argue that Lin teaches the treatment of different diseases (namely for its immunomodulatory activity and graft rejection). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, the fact that Lin is silent as to the treatment of Type 1 diabetes is the reason the rejection was made under 35 USC 103 rather than 35 USC 102. Further, it is noted that the claimed prevention only requires administration of the active substance to an individual not yet having Type 1 diabetes. The patients suggested for treatment in Lin necessarily meet this requirement, whether or not Lin describes the prevention of Type 1 diabetes.
Applicants go on to argue that Lin teaches that sorafenib inhibits the production of IL-12 while the present invention demonstrates that sorafenib is used to inhibit Stat4, which suppresses IL-12 induced Th1 cell differentiation. To this end, MPEP 2144 states that "The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem.” It is not necessary that the prior art suggest the modification to achieve the same advantage or result discovered by Applicant. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). In In re Linter, the prior art suggested the addition of sugar to a composition, where the sugar was taught to serve a different purpose than that which was discovered in the claimed invention. The court sustained the rejection, stating “The fact that appellant uses sugar for a different purpose does not alter the conclusion that its use in a prior art composition would be [sic, would have been] prima facie obvious from the purpose disclosed in the references.” 173 USPQ at 562. Similarly, in In re Dillon, the court held “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 a similar utility as one newly discovered by applicant,” and concluded that a prima facie case was established because “[t]he art provided the motivation to make the claimed compositions in the expectation that they would have similar properties.” 919 F.2d at 693, 16 USPQ2d at 1901 (emphasis in original). As such, there is no need that the skilled artisan would have had to take the prior art antibacterial agents and use them for the same purpose as intended by Applicants in order for the compounds themselves to be found obvious.
To the extent that Applicants argue that this mechanism of action is unexpected, it is noted that the prior art need not suggest every property of a product in order for the claimed invention to be prima facie obvious under § 103. For example, in In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990), the claims were rejected under § 103, on the basis that the cited prior art reference would have made obvious the claimed method. Id. at 1575—76. The court held that “merely discovering and claiming a new benefit of an old process cannot render the process again patentable. . . . While the processes encompassed by the claims are not entirely old, the rule is applicable here to the extent that the claims and the prior art overlap.” Id. at 1578. See also In re Dillon, 919 F.2d 688, 693 (Fed. Cir. 1990) (The “discovery that a claimed composition possesses a property not disclosed for the prior art subject matter, does not by itself defeat a prima facie case.”). “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Further, with respect to Applicant’s assertion that the instant application demonstrates unexpected results, it is noted that it would not have been unexpected for the reduced production of IL-12 to have the same downstream effect such as reduced Th1 cell differentiation that depends on IL-12. If there is less IL-12 available for the downstream mechanism, the same effect would be expected to be observed, even if for a different reason than that described in the prior art. The fact that Applicants have discovered an additional reason for this effect (sorafenib being capable of suppressing STAT4 phosphorylation) does not take away from the prima facie case for obviousness set forth in the previous action. Further, as noted above with respect to prevention, the only claimed requirement is administration of the same substance to the same patient population (i.e. a patient not yet having diabetes). Whether or not the prior art recognizes the effect of administering the same active substance to the same patient population, the compound is inseparable from its properties as noted above.
Applicants go on to argue that Rongrong teaches various changes observed in the mouse model for type 1 diabetes, but “it is impossible to determine whether altering one of these changes would cure the disease.” To this end, it is noted that In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., curing the diabetes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Treatment of symptoms or consequences of a disease is sufficient to read on the treatment of the disease itself, and the claimed scope is not drawn to curing the disease.
For at least the foregoing reasons, as well as those set forth in the original rejection, the rejection is maintained herein.
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 and 7-9 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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