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, filed 02/18/2022, claims domestic benefit to US provision application 63/151,962, filed 02/22/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/24/2025 has been considered by the examiner.
Claim Status
The Amendment, filed on 11/19/2025, is acknowledged in which:
Claims 5-8 are canceled.
Claim 1 is currently amended.
Claim 2-4 and 9-40 were previously presented.
Claims 1-4 and 9-40 are pending in the instant application and are examined on the merits herein.
Withdrawn Objections and Rejections
In the office action dated 07/24/2024,
All previous rejections of claims 5-8 are rendered moot in view of claim cancellations.
Claims 1, 2, 4, 7-13, 16-20, 39 and 40 were rejected under 35 USC 103 as being unpatentable over Gonzales and Olomski. Applicant’s amendment to the base claim has overcome the rejections as previously stated and the rejections are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Oyama discussed below.
Claims 3, 14-16, and 21-36 were rejected under 35 USC 103 as being unpatentable over Gonzales and Olomski, and further in view of Bammert as evidenced by Ralston. Applicant’s arguments, see Remarks (pg 9-10), filed 11/19/2025, with respect to misinterpretation of Bammert’s teachings have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Oyama and Olomski discussed below.
Claims 37-38 were rejected under 35 USC 103 as being unpatentable over Gonzales and Olomski, and further in view of Li. Applicant’s amendment to the base claim has overcome the rejections as previously stated and the rejections are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Oyama and Olomski discussed below.
Claims 1-2, 4, 6-16, and 37-39 were rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 10,526,405 B2 in view of Olomski and Fettelschoss. Applicants amendment to the base claim has overcome the rejections as previously stated and the rejections are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Olomski and Oyama discussed below.
The following grounds of objections and/or rejections are either new or modified in view of applicants amendments.
New Claim Objections
Claims 18, 29, and 30 are objected to because of the following informalities:
Regarding claim 18, “janus” should be capitalized (line 2).
Regarding claim 29, “tetanus toxoid” is repeated twice (line 2); and “N. meningitidis” should be italicized (line 3).
Regarding claim 30, “E. coli” should be italicized (line 2).
Appropriate correction is required.
Modified Claim Rejections – 35 U.S.C. § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4, 9-11, 13-16, 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Oyama (Exp Dermatol. 2018;27(1):14-21) and Olomski (Allergy. 2020 Apr;75(4):862-871).
Oyama teaches administering IL-31 in many species, including mice, dogs, and monkeys, induces pruritus, suggesting a conserved mechanism despite low IL-31 sequence homology among species (pg 18, column spanning ¶). Oyama teaches an IL-31 induced pruritus model and method of ascertaining the correct dosage of recombinant IL-31 (pg 15, right column, “Test materials” ¶ 3) for an IL-31-induced scratching model using vehicle and a range from 0.1 to 10 ug/kg administered intravenously (Figure 2A). In cynomolgus monkeys, the pruritic response with IV administration of 1ug/kg cyIL-31 was observed as transient with several animals returning to baseline response (measured 60 min before injection - i.e. baseline) by 6h post-administration (Figure 2B). Oyama also teaches a method of assessing effectiveness of an IL-31 inhibitor (anti-IL-31 antibody nemolizumab CIM331) in reducing pruritus wherein scratching movements were cumulatively counted from video recordings taken for 2h (i.e. observation window) on Days 0, 1, 3, 8, 10, 15 and 17 of monkeys that had been IV injected with ascending doses of antibody or vehicle and then dosed with an IV injection of cyIL-31 the day after (Figure 3B; Supplementary methods, pg 15 schedule table - included below). Oyama defines scratching of any part of the body with a front or hind leg as one scratching movement, though scratching bouts with only one or two scratching movements were excluded from the scratching count as they were assumed to be coincidental events (i.e. “yes/no” decision as to whether pruritic behavior was displayed). Oyama further teaches IV and subcutaneous administration (i.e. parenterally as defined by the instant specification; pg 5, lines 15-16) of anti-IL-31 antibody was sufficient to suppress scratching behaviors (Figures 3B-3D).
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Oyama does not teach adapting the model for horses (i.e. administering equine IL-31 to horses to efficacy of therapeutic intervention by an IL-31 inhibitor).
Olomski et al. teach that equine IL‐31 is detectable in insect bite hypersensitivity (IBH) skin lesions upon insect bites and mediates pruritic allergic dermatitis by targeting peripheral nerves. IL‐31 is absent in skin biopsies from non-lesion or healthy skin (Abstract). A therapeutic vaccine targeting equine IL‐31, comprising recombinant equine IL-31 coupled with CuMV, successfully induced autoantibodies against naturally induced IL‐31 as a result of IBH and reduced lesion scores in horses indicating alleviated clinical symptoms (i.e. pruritic itching), implicating a direct role for IL-31 in IBH pruritic pathology (Fig. 4; pg 870, left column, ¶ 2, last sentence). While Olomski explicitly uses a vaccine based IL-31 inhibitor, Olomski acknowledges antibodies as an alternative treatment method, and teaches that antibodies should be adjusted for use in the target species, such as “equinization” for equine mAbs (pg 870, left column, ¶ 1).
One of ordinary skill in the art would recognize IL-31 mediated pathogenesis of pruritus is likely conserved in mammals including horses. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the video recorded pruritic observation models as taught by Oyama for horses (i.e. parenterally injecting recombinant equine IL-31 to induce transient pruritic response in horses) would have a reasonable expectation of success, and a skilled artisan would be motivated to do so for developing equine-effective therapeutics for pruritus (e.g. antibodies as taught by Oyama with equinization as taught by Olomski) as Olomski teaches that inhibiting IL-31 can reduce IBH induced pruritic symptoms in horses. Furthermore, in establishing a model for horses it would be obvious to one of ordinary skill in the art to utilize a spectrum of challenge doses known in the art (i.e. values within range of the instant claim) as taught by Oyama, and that arriving at the claimed dosage amount would be a result of routine optimization (See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Claims 3, 16, and 21-36 are rejected under 35 U.S.C. 103 as being unpatentable over Oyama and Olomski as applied to claim 1 and 13 above, and further in view of US 2019/0282704 A1 (herein Bammert).
Regarding claim 3, the combined teachings of Oyama and Olomski teach claim 2 as discussed above.
While Olomski teaches methods of generating recombinant equine IL-31 (pg 864, right column, ¶ 3), they do not explicitly teach a nucleotide sequence with identity to SEQ ID NO:1.
Bammert teaches a full length equine IL-31 (SEQ ID NO: 165) with a corresponding nucleotide sequence (SEQ ID NO: 166) identical to SEQ ID NO:1 (see alignment below) (¶ [0486]). Bammert further teaches this equine IL-31 as an ortholog of canine and feline IL-31 (FIG 1A), which are used to induce pruritic responses in dogs (¶ [0454]; FIG 11C) and cats (¶ [0448]), respectively.
One of ordinary skill in the art would recognize that as Bammert teaches an identical equine IL-31 sequence as an ortholog to IL-31 used in alternative pruritus animal models, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that the corresponding recombinant protein encoded by said nucleotide sequence can be used within an IL-31-induced pruritic model as taught by the combined teachings of Oyama and Olomski with a reasonable expectation of success.
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Regarding claims 16 and 21-36, the combined teachings of Oyama and Olomski teach claim 16 as discussed above.
While Olomski acknowledges certain advantages of vaccine based inhibitors over antibodies (e.g. therapy costs of monthly intravenous monoclonal antibody injections) (pg 870, left column, ¶ 1). Neither Oyama nor Olomski teach an IL-31 vaccine mimotope.
Bammert teaches that IL-31 antibodies have been shown to improve pruritus (e.g. canine IL-31 antibody reduces pruritus in dogs), but in general immunotherapies require frequent injections, and clinical improvement may be slow to develop (¶ [0007]). As an alternative approach, Bammert teaches vaccines comprising a carrier polypeptide, an IL-31 mimotope (e.g. feline, canine, equine (¶ [0486]), or human), and an adjuvant for immunizing and/or protecting against an IL-31 mediated disorder (i.e. stimulating the mammal’s own immune system to protect against subsequent disease; ¶ [0101]) (Example 2; Claim 1). By using specific mimotopes, instead of full length, this limits the potential of non-neutralizing antibodies produced in polyclonal response to full length protein vaccines, which can result in increased amounts of bioactive IL-31 in circulation resulting from bound antibody cytokine complexes, exacerbating pruritic activity (¶ [0462]). Bammert teaches various constrained (chemically-linked cyclic peptide) mimotopes fused to carrier protein CRM-197 (¶ [0465]-[0468]) (i.e. derivative of diphtheria toxin (bacterial); ¶ [0035]), and teaches suitable alternatives to include other bacterial toxoids or derivatives (e.g. tetanus, outer membrane protein complex from group B N. meningitidis, or Pseudomonas exotoxin), keyhole limpet hemocyanin, or virus-like particles (e.g. HBsAg, HBcAg, E. coli bacteriophage Qbeta, Norwalk virus, canine distemper virus (CDV), or influenza HA) (¶ [0035]). Bammert teaches formulations using an adjuvant mixture including glycolipid Bay R1005 as well as CpG oligonucleotides (¶ [0089] and [0481]), and teaches suitable alternatives to include species that overlap with those recited in the instant claims (e.g. oil-in-water adjuvant, a polymer and water adjuvant, a water-in-oil adjuvant, an aluminum hydroxide adjuvant, a vitamin E adjuvant and combinations thereof; formulations comprising a saponin (e.g. Quil A), a sterol (e.g. cholesterol), a quaternary ammonium compound (e.g. DDA), and a polymer (e.g. polyacrylic acid) (¶ [0036]-[0038]). Bammert further teaches that mice immunized with full length equine vaccine (equine IL-31 conjugated with CRM-197) developed an immune responses that recognizes the specific mimotope peptides, suggesting these mimotopes as relevant immunogens for antibody targeting in vivo (¶ [0486]; FIG 21B).
One of ordinary skill in the art would recognize that an IL-31 mimotope vaccine as taught by Bammert could be substituted for the antibody IL-31 inhibitor as taught in the IL-31-induced pruritic model as taught by the combined teachings of Oyama and Olomski with a reasonable expectation of success as Bammert teaches a mimotope vaccine is sufficient to induce an immune response with repeated exposure of the IL-31 “immunogens” and a skill artisan would be motivated to do so as Bammert further teaches vaccines facilitate long-term prevention in comparison with immunotherapy.
Claims 12, 16-20, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Oyama and Olomski as applied to claim 1 and 11 above, and further in view of Gonzales (Vet Dermatol. 2016 Feb;27(1):34-e10)
Regarding claims 12 and 16-18, The combined teachings of Oyama and Olomski teach claims 1 and 11 as discussed above.
However, neither reference teaches 1 minute intervals for pruritic scoring.
Gonzales teaches a similar IL-31-induced pruritus model for evaluating the efficacy of small molecule inhibitors (e.g. oclacitinib (Abstract), defined by the instant specification as and IL-31 inhibitor small molecule compound that targets Janus kinase - pg 27, lines 24-28), wherein categorical “yes/no” decisions were made at discrete 1 min intervals with regard to whether at least one pruritic behavior was displayed by the study animals (pg 35, Video surveillance and pruritus monitoring). Gonzales uses this method as a means to control for treatment and random batch effects (i.e. measuring overall pruritic response duration rather than amplitude) (pg 35, column spanning ¶).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that the method as taught by the combined teaching of Oyama and Olomski could be modified for 1 minute pruritic scoring intervals as taught by Gonzales and would be motivated to do so to control for treatment and random batch effects of commercially available inhibitors (e.g. small molecule inhibitors).
Regarding claims 19-20 and 40, The combined teachings of Oyama, Olomski, and Gonzales teach claim 17 as discussed above. Gonzales further teaches that the tested small molecule (e.g. oclacitinib) were combined with a pharmaceutically acceptable carrier cellulose (i.e. feed carrier) and administered to the subjects orally (pg 35, Test Drugs).
Response to Arguments - 35 U.S.C. § 103
Applicant's arguments regarding claim rejections under 35 USC 103, filed 11/25/2024, have been fully considered in so far as they apply to the modified rejections above, but they are not persuasive.
Applicant states:
“To summarize, Olomski et al. fails to teach that in vivo administration of IL-31 protein can induce pruritus in horses. Rather, it only disclosed in vitro administration of an insect-derived allergen which could affect any number of Th2-associated cytokines or chemokines, many of which were never tested in that document. Secondly, it fails to disclose that exposure to the allergen led to an increase in levels of functional equine IL-31 protein since only IL-31 mRNA expression was tested. Thirdly, it supports that there was a trend towards higher mRNA expression levels in skin lesions for two other proteins, namely TSLP and MCP-1, confirming earlier data by other investigators, which points to those as possibly playing a role in IBH. Fourthly, Olomski does not disclose or suggest that blocking IL-31 protein with the vaccine-induced anti-lL-31 autoantibodies blocks IL-31 pruritus since they were only evaluating tissue damage of the skin in the form of lesions.” (Remarks, pg 13, ¶ 3)
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). Furthermore, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, while Olomski et al. does teach additional factors in Th2-associated allergic response in IBH (e.g. expression of TSLP and MCP-1), Olomski et al. further teach, through use of a specific vaccine targeting equine IL-31 that on average increases anti-eIL31 IgG titer (i.e. autoantibodies – Figure 3C), that IL-31 plays a non-trivial role in equine pruritic response to allergens by reducing self-inflicted skin destruction (i.e. intense scratching in horses that suffer from strong pruritus - pg 863, column 2, ¶ 1), and therefore it would be obvious to one of ordinary skill in the art that a known model which utilizes injecting recombinant IL-31 in mammals to develop anti-pruritic response (a molecular mechanism conserved in many mammals such as mice, dogs, and humans) to develop therapeutics as taught by Oyama et al. would be viable in equines.
Applicant states:
“The authors of Olomski et al. were evidently aware of administering canine IL-31 to dogs for evaluating therapeutic efficacy, as they reference Gonzales et al. (reference 40 in Olomski et al). They also had access to recombinant equine IL-31 protein (see section 2.7). Given these facts, a real-life assessment should question why the authors of Olomski et al. did not administer equine IL-31 to the horses to test the efficacy of the IL-31 based vaccine if it was indeed obvious to do so. Instead, in Olomski et al. the efficacy of the IL-31 based vaccine was evaluated by allowing horses to naturally acquire insect bites. The fact that the authors of Olomski et al. despite having knowledge of Gonzales et al. [IL-31 administration to induce pruritus] and access to the necessary protein, did not arrive at the present invention strongly indicates that the present invention would not have been obvious to one of ordinary skill in the art.” (Remarks, pg 9, ¶ 3)
In response to applicant’s argument, the disclosure of alternatives does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention (In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004). In this instance, Olomski mere use of an insect bite model does not constitute a teaching away from the alternative direct IL-31-induced pruritus as taught by Oyama because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed. Moreover, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Further, "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). In this instance, Olomski infers IL-31 as mechanistically relevant to inducing pruritic response in horses, and therefore a skilled artisan would recognize that pruritic response to IL-31 administration, evidenced as conserved in other mammal as taught by Oyama, would have a reasonable expectation of being conserved in horses as well.
Applicant states:
“…0.1 to 0.25 μg/kg is a non-obvious dose range and is inventive on the basis that the high post challenge scores associated with higher doses were a problem in horses not expected from the prior art. (Remarks, pg 10, ¶ 3)
In regard to the specific dosage amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); See M.P.E.P. § 2144.05 (II)(A)). Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." (In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989)). This because, as is made clear from the prior art, the determination of the dosage regimen of a known pruritic agent IL-31 is well within the purview of one of ordinary skill in the art at the time the invention was made as taught by Oyama, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the art. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the prior art and claimed method perform the same protocol to achieve the same results. Moreover, as the claimed dosage is in range of tested doses contemplated by the prior art the fact that applicant has identified a latent property or additional advantage (i.e. reducing animal discomfort through inherent reduction of itching behaviors with lower doses of IL-31) of using a particular dose within said known range, does not lend patentability to an otherwise unpatentable invention (See MPEP 2145(II)).
Regarding unexpected results, applicant argues that with too high an IL-31 dose, a therapeutic would be unable to overcome the IL-31 induced pruritic behavior, however data presented for therapeutic intervention experiments only utilize a single concentration of IL-31 (0.25 μg/kg) (Table 9). MPEP 716.02(b)(I) dictates that evidence relied upon to establish results are unexpected and significant should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance" (Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)). Further, mere conclusions that results are unexpected "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration." (Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992). While the lack of objective evidence of nonobviousness does not weigh in favor of obviousness, (Miles Labs. Inc. v. Shandon Inc., 997 F.2d 870, 878, 27 USPQ2d 1123, 1129 (Fed. Cir. 1993), cert. denied,127 L. Ed. 232 (1994)), where a prima facie case of obviousness is established, the failure to provide rebuttal evidence is dispositive.
Modified Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
US 10,526,405 B2
Claims 1-2, 4, 9-16, 37-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-15, and 17-19 of U.S. Patent No. 10,526,405 B2 (herein US405) in view of Olomski and Oyama (both cited above).
US405 claims an method of evaluating anti-pruritic effects of IL-31 targeted canine therapeutics (US405 claim 1) using recombinant canine IL-31 (US405 claim 2) wherein the IL-31 is administered parenterally (US405 claim 3) and the pruritic response is transient lasting less than 24h (US405 claims 6 and 7). US405 further claims pruritic response is selected based on behaviors including chewing (i.e. biting), scratching, and head shaking (US405 claim 8) measured using real-time video surveillance using a categorical scoring system (US405 claim 9) identical to the instant invention (US405 claims 10-14). US405 also claims the candidate inhibitor as a monoclonal antibody, wherein the antibody is caninized and administered parenterally (US405 claims 17-19)
US405 methods only differ from instant claims in that the animal model is canine, whereas the instant application is equine, and does not recite a IL-31 challenge administered at the same dosage.
Olomski teaches a therapeutic vaccine targeting equine IL‐31 (eIL‐31‐CuMVTT) successfully induces autoantibodies against IL‐31 and reduces lesion scores in horses indicating alleviated clinical symptoms (i.e. pruritic itching), implicating a direct role for IL-31 in IBH pruritic pathology (Fig. 4; pg 870, left column, ¶ 2, last sentence). While Olomski explicitly uses a vaccine based IL-31 inhibitor, Olomski acknowledges antibodies as an alternative treatment method, and teaches that antibodies should be adjusted for use in the target species, such as “equinization” for equine mAbs (pg 870, left column, ¶ 1).
Oyama teaches an IL-31-induced pruritus model for testing the efficacy of IL-31 inhibitor treatment by administering recombinant IL-31 to a subject, and teaches a method of ascertaining the correct dosage of recombinant IL-31 (pg 15, right column, “Test materials” ¶ 3) for said model using vehicle and a range from 0.1 to 10 ug/kg IL-31 administered intravenously (Figure 2A).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the model taught by US405 for canines, substituting the canine/caninized elements for equine/equinized elements, to evaluate anti-pruritic effects of equine therapeutics with a reasonable expectation of success because Olomski et al. teaches that IL-31-mediated pruritic symptoms are conserved in horses and can be targeted through inhibiting IL-31 to alleviate itching. Furthermore, in establishing a model for horses, it would be obvious to one of ordinary skill in the art to utilize a spectrum of challenge doses known in the art (i.e. values within range of the instant claim) as taught by Oyama, and that arriving at the claimed dosage amount would be a result of routine optimization (See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Response to Arguments - Double Patenting
Applicant's arguments regarding claim rejections under nonstatutory double patenting, filed 11/25/2024, have been fully considered in so far as they apply to the modified rejections above, but they are not persuasive.
Applicant states:
“…neither Olomski et al. nor Fettelschoss et al. teach or suggest administration of IL-31 at any dose to a horse. The data in Example 1 of the application support that 0.1 to 0.25 μg/kg is a non-obvious dose range and is inventive on the basis that the high post challenge scores associated with higher doses were a problem in horses not expected from the prior art..” (Remarks, pg 13, ¶ 3)
In response to applicant's arguments regarding “unexpected results” see ‘Response to Arguments - 35 USC 103’ (10)(iii) above. Briefly, the claimed range is within scope of administration range taught within the prior art in a testing model conserved in mammals such as monkeys, mice, dogs, humans, and likely horses (i.e. modified rejection in view of Oyama and Olomski), and discovery of an optimum value for horses does not render the instant claims nonobvious without additional experimental evidence.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNAH SUNSHINE whose telephone number is (571)270-7417. The examiner can normally be reached M-Th & Second Friday 8:30am-5pm EST.
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/HANNAH SUNSHINE/Examiner, Art Unit 1647
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647