DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 29, 2025 has been entered.
Claims 1-10 and 13-19 are pending in the instant application.
Claims 1-9 stand withdrawn from consideration as being drawn to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03, for reasons of record set forth in the restriction requirement mailed August 29, 2024.
Claims 10 and 13-19 are under examination in this office action.
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.
The rejection of claims 10, 11, 12 and 13-19 under 35 U.S.C. 103 as being unpatentable over Bornal et al. (WO 2016/154362) in view of Schulz et al. and in view of Jhaveri et al. (WO 2019/165436) has been withdrawn in view of the declaration by inventor Gannavaram under 37 CFR 1.132 received July 29, 2025.
Specifically, the declaration sets forth evidence that the aryl hydrocarbon receptor agonists kynurenine and kynurenic acid differ from other aryl hydrocarbon receptor (AhR) agonists with regard to elaborated cytokines and that such differences were unexpected. Given that the primary reference does not teach that kynurenine and/or kynurenic acid are preferred as compared to other known AhR agonists such as FICZ applicant’s assertions that differences in cytokine elaboration between what is presently claimed and other possible AhR agonists are unpredictable has been found to be persuasive.
Claims 10, 13, 14, and 18 stand rejected under 35 U.S.C. 103 as being unpatentable over Taher et al. (of record) in view of Jhaveri et al. (WO 2019/165436, of record) and in view of Kawasaki et al. (of record).
Taher et al. disclose that tryptophan metabolites contribute to tolerance induction in a mouse model of immunotherapy (see entire document, particularly the abstract and discussion sections). They disclose administration of allergen (ovalbumin, an food allergen found predominantly in chicken egg whites) at the same time as administration of kynurenine and kynurenic acid, with such protocols reducing eosinophil numbers in animals thus treated (see Figures 1 and 3-5). Taher et al. teach that IDO-dependent tryptophan metabolites (which include kynurenine and kynurenic acid) are involved in tolerance induction by allergen immunotherapy (see particularly the left column of the Discussion section on page 989 as well as the final paragraph on page 990). These teachings differ from the instant claimed invention in that the allergen and kynurenine/ kynurenic acid were not present in the same composition that was administered to the animal.
Jhaveri et al. disclose liposomes containing the AhR agonist ITE and antigens that are to be administered to subjects in order to introduce tolerance to said antigens (see entire document, particularly the abstract, claims and page 2). Antigens are disclosed as being autoantigens, such as preproinsulin in diabetes, as well as allergens including animal dander, pollen, dust mites, insect bites, nuts, eggs, seafood, and grain (see particularly page 21). The liposomes are disclosed as being administered via a variety of routes including intravenous, subcutaneous, intradermal, and transdermally (see particularly pages 32-33). Notably the liposomes are disclosed as being nano-sized (see particularly page 11).
Kawasaki et al. disclose that kynurenine is an agonist of the aryl hydrocarbon receptor (see entire document).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the invention to place the allergen and kynurenine in the same pharmaceutical composition for use in allergen tolerance induction treatments. This is because administering both allergen and kynurenine was known to be effective in inducing tolerance as taught by Taher et al., kynurenine is an agonist of the aryl hydrocarbon receptor as shown by Kawasaki et al., and compositions comprising aryl receptor agonists and allergens are known to be beneficial in inducing tolerance to allergens as taught by Jhaveri et al. Artisans would believe such combinations would have a reasonable expectation of success given that administering allergen and kynurenine and allergen on the same day to subjects was beneficial in reducing the signs and symptoms of allergic sensitization as shown by Taher and because artisans would readily know how to make such a composition based upon the teachings of Jhaveri et al.
Additionally, it should be pointed out that as per MPEP 2144.04(V)(B), it is obvious to make separate things integral. In the instant case, Taher et al. administered separate pharmaceutical compositions comprising ovalbumin and kynurenine to induce tolerance as thus it is obvious to combine such separate compositions int a single composition to induce tolerance. Note that doing so has the advantage of being easier as only one rather than two administration steps would be needed when practicing the tolerance induction methods of Taher et al.
Applicant's arguments filed July 29, 2025 have been fully considered but they are not persuasive. Applicant argues that the declaration of inventor Gannavaram under 37 CFR 1.132 establishes that using kynurenine and kynurenic acid unexpectedly elaborates different cytokines as compared to other AhR agonists such as FITZ, and thus “given the surprising results demonstrated for KynA and Kyn compounds as compared to another AhR agonist, Applicant respectfully requests withdrawal of the rejection”.
This argument has been considered and is not persuasive, Taher et al., the primary reference, teaches administering kynurenine in combination with ovalbumin (a well-known egg allergen) “contribute[s] or tolerance induction regarding TH2-dependnet allergic airway inflammation.” (see particularly the “conclusion” section at the top of the right column of page 983). As such there is no reason to select from a list of AhR antagonists as Taher et al. explicitly teach the administration of kynurenine and an allergen induces tolerance. As pointed out in the rejection of record reproduced above, the teachings of Taher et al. differ from what is presently claimed in that Taher et al. did not combine ovalbumin and kynurenine into the same composition for simultaneous administration and why combining separate reagents into a single composition is an obvious variation. It should be pointed out that the instant claimed product of independent claim 10 is a composition comprising two active ingredients 1) kynurenine or kynurenic acid and 2) an allergen. The declaration of inventor Gannavaram does not speak to anything “unexpected” concerning AhR agonists and allergens being in the same rather than separate compositions, which is the defining difference between the teachings of Taher et al. and that which is presently claimed. Indeed, the coculture data of the declaration was collected in the absence of any allergen whatsoever. Thus, contrary to applicants assertions, the data of the Gannavaram declaration is not probative to the question of separate versus a combined composition.
Further, it should be noted that since the same reagents (allergen + AhR agonist, specifically ovalbumin + kynurenine) were administered to a subject and shown to induce tolerance, the possible mechanism by which tolerance induction was achieved, such as elaboration of particular cytokines, occurred in the subjects of Taher et al. whether observed or not. Products and their functional activities are not separable. As such arguments concerning which gene products are or are not upregulated is not probative concerning if artisans would use a combined composition or two separate composition comprising the same things for administration to the same subject for the same purpose.
The rejection is maintained.
Claims 15-17 and 19 stand rejected under 35 U.S.C. 103 as being unpatentable over Taher et al. (of record) in view of Jhaveri et al. (WO 2019/165436, of record) and in view of Kawasaki et al. (of record) as applied to claims 10, 13, 14 and 18 above, and further in view of Mondoulet et al. (WO 2015/107081, of record).
The inventions rendered obvious by the combined teachings of Taher et al., Jhaveri et al., and Kawasaki et al. have been discussed above and differ from the instant claimed invention in that allergen tolerizing liposomes of are not disclosed as being delivered via a continuous epicutaneous route, such as that obtained by use of dermal patches in epicutaneous immunotherapy.
Mondoulet et al. disclose continuous epicutaneous delivery of antigen via skin patches to treat allergic and autoimmune diseases (see entire document, particularly the abstract, claims, and pages 3 and 8). Such methodologies are disclosed as being advantageous as they induce regulatory T cell subsets that improve the condition of the treated subject and achieve tolerance to the antigen in question (see for example pages 8, 13, and 14).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of filing to deliver the tolerance inducing liposomes using continuous epicutaneous delivery, such as that obtainable by a dermal patch, in order to gain the advantage of eliciting regulatory T cells that will achieve antigen tolerance as per the teachings of Mondoulet et al.
Applicant's arguments filed July 29, 2025 have been fully considered but they are not persuasive. Applicant argues that the base obviousness rejection is not tenable and that the additional teachings of Mondoulet et al. do not rectify its deficiencies.
This argument is not persuasive as applicant’s arguments is not persuasive as discussed above and no particular teachings concerning Mondoulet et al. appear to be argued separately by applicant.
No claims are allowable.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641