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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22, 2026 has been entered.
Claims 1-2, 17, 19, 40-41, 43-44, 49, 80, and 82-84 are pending in the application. Claims 43-44 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed March 31, 2021.
Claims 1-2, 17, 19, 40-41, 49, 80, and 82-84 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated December 17, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 22, 2026 was filed after the mailing date of the first Office action on the merits on May 5, 2021. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant argues that Orengo, Ardeleanu, and Matsumoto, alone or in combination, do not teach or disclose treating asthma in a subject by administrating the combination of the claimed antibodies at an initial and a maintenance dose of 300 mg every other week, thereby improving FEV1 or pre-bronchodilator FEV1 in the subject, to the specific patient population recited in the instant claims.
Applicant further argues that the cited references do not teach that FEV1 or pre-bronchodilator FEV1 is improved upon administration of the claimed antibodies.
Applicant further argues that none of the cited references teach or disclose administering the combination of the claimed antibodies at the claimed doses or dosing regimen, or administering the combination of the claimed antibodies to an adult subject who has asthma, a blood eosinophil count of greater than 300 cells/uL, and blood periostin level of greater than to equal to 74.4 ng/mL, as required by the instant claims.
Applicant's arguments have been considered fully but are not found to be persuasive.
As stated previously, Orengo claims a method for treating an inflammatory disease or disorder of the airway or lungs of a subject in need thereof, comprising administering an interleukin-33 (IL-33) antagonist in combination with an interleukin-4 receptor (IL-4R) antagonist (claim 1: "A method for treating an inflammatory disease or disorder, or at least one symptom associated with the inflammatory disease or disorder, the method comprising administering to a subject in need thereof one or more doses of a therapeutically effective amount of an interleukin-33 (IL-33) antagonist in combination with one or more doses of a therapeutically effective amount of an interleukin-4 receptor (IL-4R) antagonist, wherein the administration of the combination results in enhanced therapeutic efficacy as compared to that observed with administration of the IL-33 antagonist alone or the IL-4R antagonist alone.").
Orengo further teaches dosages of the IL-33 and IL-4R antagonist of 300 mg (para. 0221: "In certain embodiments, 75 mg, 150 mg, 200 mg, or 300 mg of an IL-33 antagonist is administered to a subject in combination with an IL-4R antagonist."). Orengo also teaches administration of maintenance doses once every two weeks (para. 0232-0233).
Orengo further teaches that the inflammatory disease or disorder may be eosinophilic asthma (para. 0015, 0038, and 0225).
Orengo further teaches that the IL-4R antagonist may be dupilumab, and the IL-33 antagonist may be REGN3500, which is the same as SAR440340 (para. 0013: "In one embodiment, the method of treating an inflammatory disorder or condition is accomplished through use of a combination of REGN3500 ... and dupilumab..."). According to Applicant's specification at page 41, SAR440340 and dupilumab possess the claimed sequences of complementarity determining regions recited in claims 1 and 17.
Ardeleanu teaches that treatment of asthma with an IL-4R antagonist increases FEV1 (para. 0010). Ardeleanu also teaches that the IL-4R antagonist may be administered with one or more additional therapeutic agents (para. 0141).
Ardeleanu also teaches initial doses of 300 mg, followed by additional dosages of 300 mg every two weeks (para. 0145).
Since Ardeleanu teaches that treatment with IL-4R antagonist improves FEV1 in patients with asthma, and Orengo teaches administration of the IL-4R antagonist to patients with asthma, it follows that such a treatment would improve FEV1 in this patient population.
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01.
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). MPEP 2145(II).
Ardeleanu further teaches that patients with eosinophilic asthma may have blood eosinophils greater than or equal to 300 cells/uL (para. 0013). Ardeleanu also teaches that periostin levels are found to be upregulated in patients with asthma, and that IL-4R antagonists are useful in treating patients with elevated levels of periostin (para. 0158).
Matsumoto teaches that a population of patients with asthma had an average serum periostin level of 92.8 ng/mL, compared to a population of healthy subjects with an average serum periostin level of 39.1 ng/mL (page 154, right column, fourth and fifth paragraphs).
Given that Orengo teaches treatment of asthma, and elevated levels of blood eosinophils and periostin were known in the art to be associated with asthma according to Ardeleanu and Matsumoto, respectively, it follows that one of ordinary skill would apply the treatment of Orengo to a patient population with elevated levels of blood eosinophils and periostin.
The rejection under 35 U.S.C. 103 to Orengo in view of Ardeleanu and Matsumoto is therefore maintained.
Applicant argues that the 17/786,226 application has a patent term filing date and base expiration date later than that of the instant application, and therefore, and obviousness-based double patenting rejection is not proper.
Applicant's arguments have been considered fully but are not found to be persuasive.
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent. MPEP 804(I)(A)(1)(b)(i).
As the claims are not in condition for allowance, the double patenting rejection to the 17/786,226 application is maintained.
Applicant argues that one of ordinary skill would not have been motivated to pick and choose the specific initial and maintenance doses for the IL-33 antagonist in combination with the specific initial and maintenance doses for the IL-4R antagonist and the specific dosing regimen to treat patients with asthma having specific blood eosinophil counts and periostin levels, based upon the claims of U.S. patent No. 10,815,305 in view of Ardeleanu, Matsumoto, and Clinical Trial NCT03387852, or the claims of U.S. patent No. 11,866,503 in view of Ardeleanu, Matsumoto, and Clinical Trial NCT03387852.
Applicant's arguments have been considered fully but are not found to be persuasive.
Ardeleanu teaches dosages of an IL-4R antagonist of 300 mg (para. 0139). Ardeleanu also teaches maintenance doses (para. 0145).
Ardeleanu further teaches that patients with eosinophilic asthma may have blood eosinophils greater than or equal to 300 cells/µL (para. 0013).
Ardeleanu further teaches that periostin levels are found to be upregulated in patients with asthma, and that IL-4R antagonists are useful in treating patients with elevated levels of periostin (para. 0158).
Matsumoto teaches that serum periostin is a strong predictor of airway eosinophilia in patients with severe asthma who remain symptomatic despite maximal ICS treatment (page 154, right column, second paragraph). Matsumoto further teaches that a population of patients with asthma had an average serum periostin level of 92.8 ng/mL, compared to a population of healthy subjects with an average serum periostin level of 39.1 ng/mL (page 154, right column, fourth and fifth paragraphs).
The teachings of Ardeleanu and Matsumoto make it clear that a patient with eosinophilic asthma may have a blood eosinophil count of greater than 300 cells/µL and a blood periostin level of >74.4 ng/mL.
As stated previously, determination of dosage is routinely determined by the ordinary artisan as of the effective filing date of the claimed invention, and was known as a result effective variable that depends on the conditions of the patients. 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) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). One of ordinary skill in the art would appreciate the amount or dosage of the antibody in the therapy could be adjusted to achieve optimum therapeutic efficacy. Applicant has not presented evidence of any unexpected criticality of the claimed dosage schedule. Additionally, Ardeleanu teaches that one of ordinary skill can determine effective dosages and schedules (para. 0129).
The double patenting rejection to U.S. patent No. 10,815,305 in view of Ardeleanu, Matsumoto, and Clinical Trial NCT03387852 is therefore maintained.
The double patenting rejection to U.S. patent No. 11,866,503 in view of Ardeleanu, Matsumoto, and Clinical Trial NCT03387852 is therefore maintained.
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.
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 1-2, 17, 19, 40-41, 49, 80, and 82-84 are rejected under 35 U.S.C. 103 as being unpatentable over Orengo (US20180155436A1) in view of Ardeleanu (US20140056920A1) and Matsumoto (Allergol Int. 2014 Jun;63(2):153-60).
Orengo claims a method for treating an inflammatory disease or disorder of the airway or lungs of a subject in need thereof, comprising administering an interleukin-33 (IL-33) antagonist in combination with an interleukin-4 receptor (IL-4R) antagonist (claim 1). Orengo further teaches that this treatment may improve respiratory function, as assessed by post bronchodilator forced volume in 1 second (FEV1) (para. 0329).
Orengo further teaches dosages of the IL-33 and IL-4R antagonist of 300 mg (para. 0221).
Orengo also teaches administration of maintenance doses once every two weeks (i.e., "maintenance doses") (para. 0232-0233).
Orengo further teaches that the inflammatory disease or disorder may be eosinophilic asthma (para. 0015, 0038, and 0225).
Orengo further teaches that the subject may have moderate-to-severe asthma that is not well controlled on inhaled corticosteroid (ICS) plus long-acting β2 adrenergic agonist (LABA) therapy (para. 0334), which is pertinent to claims 2 and 82.
Orengo further teaches that the IL-4R antagonist may be dupilumab, and the IL-33 antagonist may be REGN3500, which is the same as SAR440340 (claim 28), which is pertinent to claim 17 and 83. According to Applicant's specification at page 41, SAR440340 and dupilumab possess the claimed sequences of complementarity determining regions recited in claims 1, and 17.
Orengo further teaches that patients may be above 18 years of age (para. 0340).
Orengo further teaches that the above IL-33 and IL-4R antagonists may be administered subcutaneously (para. 0106), which is pertinent to claim 19.
Orengo further teaches that the above IL-33 and IL-4R antagonists may be administered at the same time or in separate dosage forms (para. 0228-0232), which is pertinent to claims 40-41 and 80.
Orengo further teaches the use of an autoinjector (para. 0216), which is pertinent to claim 84.
However, Orengo does not teach the use of blood eosinophil count or blood periostin level to select a patient.
Ardeleanu teaches the administration of an anti-IL-4R antibody for the treatment of asthma, which comprises the light and heavy chains of dupilumab (claim 2). Ardeleanu also teaches doses of the antibody from 75 mg to 600 mg, administered by injection (claims 3-4). Ardeleanu also teaches that the patient has moderate-to-severe asthma that is uncontrolled with a background asthma therapy comprising an ICS, a LABA, or a combination thereof, and that treatment reduces dependency on these drugs (claim 10 and para. 0015), which is pertinent to claim 2.
Ardeleanu further teaches that this treatment may improve FEV1 (para. 0010, 0073-0075 and Figure 2).
Ardeleanu further teaches “maintenance doses” of the above therapy, which are administered 2 weeks after the preceding dose (para. 0147-0148).
Ardeleanu also teaches that the IL-4R antagonist may be administered with one or more additional therapeutic agents (para. 0141).
Ardeleanu further teaches that patients with eosinophilic asthma may have blood eosinophils greater than or equal to 300 cells/uL (para. 0013).
Ardeleanu further teaches that periostin levels are found to be upregulated in patients with asthma, and that IL-4R antagonists are useful in treating patients with elevated levels of periostin (para. 0158).
Matsumoto teaches that serum periostin is a strong predictor of airway eosinophilia in patients with severe asthma who remain symptomatic despite maximal ICS treatment (page 154, right column, second paragraph).
Matsumoto further teaches that a population of patients with asthma and an average age of 62.3 years had an average serum periostin level of 92.8 ng/mL, compared to a population of healthy subjects with an average serum periostin level of 39.1 ng/mL (page 154, right column, fourth and fifth paragraphs).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Orengo, Ardeleanu, and Matsumoto to arrive at the claimed invention. Orengo teaches that combination therapies of an interleukin-33 (IL-33) antagonist and an interleukin-4 receptor (IL-4R) antagonist are useful in treating eosinophilic asthma. Ardeleanu teaches that patients with eosinophilic asthma may have blood eosinophils greater than or equal to 300 cell/uL, and Matsumoto teaches that patients with asthma may have serum periostin of 92.8 ng/mL. Using the definitions from Ardeleanu and Matsumoto, a skilled artisan could select the appropriate patient population to apply the treatment plan of Orengo.
All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods (e.g., applying a known therapy to a specific, defined patient population) with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
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.
Claims 1-2, 17, 19, 40-41, 49, 80, and 82-84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9, 20-21, 25, 32, 37 and 44-45 of copending Application No. 17/786,226 in view of Ardeleanu and Matsumoto.
The '226 application claims a method for treating allergic asthma in a subject in need thereof comprising administering to the subject an antibody or antigen-binding fragment thereof that specifically binds interleukin-33 (IL-33) or an antibody or antigen-binding fragment thereof that specifically binds interleukin-4R (IL-4R), with both claimed antibodies having the same CDRs as the instantly claimed antibodies (claim 1, also see claim 20).
The '226 application further claims the above antibodies are administered subcutaneously at doses 300 mg (claim 2).
The '226 application further claims the above antibodies are administered every other week (claim 9).
The '226 application further claims that the above method reduces loss of asthma control (LOAC) in the subject (claim 37).
The '226 application further claims that the above method improves one or more asthma- associated parameter(s) (claim 44), and the asthma-associated parameter is selected from the group consisting of forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow (FEF) 25%-75%, and reduction of the frequency or the dosage of short-acting inhaled p2 agonist use in the subject; or wherein pre- bronchodilator FEV 1 is improved in the subject (claim 45).
The '226 application claims that the antibodies may be dupilumab (claim 21 and 96), and the antibodies of the '226 application have identical complementarity determining regions to those of SAR440340, which is pertinent to claim 83.
The '226 application claims that the antibodies in question may be administered with an autoinjector (claim 25 and 97), which is pertinent to claim 84.
However, the '226 application does not teach the use of blood eosinophil count or blood periostin level to select a patient.
Ardeleanu teaches "maintenance doses" of the above therapy, which are administered 2 weeks after the preceding dose (para. 0147-0148).
Ardeleanu further teaches that patients with eosinophilic asthma may have blood eosinophils greater than or equal to 300 cells/uL (para. 0013).
Ardeleanu further teaches that periostin levels are found to be up regulated in patients with asthma, and that IL-4R antagonists are useful in treating patients with elevated levels of periostin (para. 0158).
Ardeleanu teaches that the background therapy may comprise an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA) (para. 0015), which is pertinent to claim 82.
Matsumoto teaches that serum periostin is a strong predictor of airway eosinophilia in patients with severe asthma who remain symptomatic despite maximal ICS treatment (page 154, right column, second paragraph).
Matsumoto further teaches that a population of patients with asthma and an average age of 62.3 years had an average serum periostin level of 92.8 ng/mL, compared to a population of healthy subjects with an average serum periostin level of 39.1 ng/mL (page 154, right column, fourth and fifth paragraphs).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the '226 application with the teachings of Ardeleanu and Matsumoto to arrive at the claimed invention. The '226 application teaches that combination therapies of an interleukin-33 (IL-33) antagonist and an interleukin-4 receptor (IL- 4R) antagonist are useful in treating asthma. Ardeleanu teaches that patients with eos inophilic asthma may have blood eosinophils greater than or equal to 300 cell/uL, and Matsumoto teaches that adult patients with asthma may have serum periostin of 92.8 ng/ml. Using the definitions from Ardeleanu and Matsumoto, a skilled artisan could select the appropriate patient population to apply the treatment plan of the '226 application. All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods (e.g., applying a known therapy to a specific, defined patient population) with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 17, 19, 40-41, 49, 80, and 82-84 are rejected on the ground of nonstatutory double patenting as being unpatentable overclaims 1-44 of U.S. Patent No. 10,815,305 in view of Ardeleanu, Matsumoto and Clinical Trial NCT03387852 (cited previously).
The '305 patent claims a method for treating an inflammatory disease or disorder of the airway or lungs of a subject in need thereof, comprising administering an interleukin-33 (IL-33) antagonist in combination with an interleukin-4 receptor (IL-4R) antagonist (claim 1). The IL-4R antagonist may be dupilumab, and the IL-33 antagonist may be REGN3500, which is the same as SAR440340 (claim 28).
However, the '305 patent does not teach the use of blood eosinophil count or periostin levels to select a patient.
Clinical Trial NCT03387852 teaches a dosage schedule of SAR440340 and Dupilumab, administered every two weeks (page 4).
Clinical Trial NCT03387852 also teaches that the above treatment may have an effect on FEV1 (page 3).
Ardeleanu teaches "maintenance doses" of the above therapy, which are administered 2 weeks after the preceding dose (para. 0147-0148).
Ardeleanu further teaches that patients with eosinophilic asthma may have blood eosinophils greater than or equal to 300 cells/uL (para. 0013).
Ardeleanu further teaches that periostin levels are found to be up regulated in patients with asthma, and that IL-4R antagonists are useful in treating patients with elevated levels of periostin (para. 0158).
Ardeleanu further teaches that the background therapy may comprise an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA) (para. 0015), which is pertinent to claim 82.
Ardeleanu further teaches that the compositions in question may be administered with an autoinjector (para. 0132), which is pertinent to claim 84.
Matsumoto teaches that serum periostin is a strong predictor of airway eosinophilia in patients with severe asthma who remain symptomatic despite maximal ICS treatment (page 154, right column, second paragraph).
Matsumoto further teaches that a population of patients with asthma and an average age of 62.3 years had an average serum periostin level of 92.8 ng/mL, compared to a population of healthy subjects with an average serum periostin level of 39.1 ng/mL (page 154, right column, fourth and fifth paragraphs).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the “305 patent with the teachings of Clinical Trial NCT03387852, Ardeleanu and Matsumoto to arrive at the claimed invention. The ‘305 patent teaches that combination therapies of an interleukin-33 (IL-33) antagonist and an interleukin-4 receptor (IL-4R) antagonist are useful in treating asthma. Ardeleanu teaches that patients with eosinophilic asthma may have blood eosinophils greater than or equal to 300 cell/uL, and Matsumoto teaches that adult patients with asthma may have serum periostin levels of 92.8 ng/ml. Using the definitions from Ardeleanu and Matsumoto, a skilled artisan could select the appropriate patient population to apply the treatment plan of the ‘305 patent. All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods (e.g., applying a known therapy to a specific, defined patient population) with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
While the cited references do not explicitly teach the claimed dosage of the IL-33- binding antibody, determination of dosage is routinely determined by the ordinary artisan as of the effective filing date of the claimed invention, and was known as a result effective variable that depends on the conditions of the patients. 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) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). One of ordinary skill in the art would appreciate the amount or dosage of the antibody in the therapy could be adjusted to achieve optimum therapeutic efficacy. Applicant has not presented evidence of any unexpected criticality of the claimed dosage schedule.
Claims 1-2, 17, 19, 40-41, 49, 80, and 82-84 are rejected on the ground of nonstatutory double patenting as being unpatentable overclaims 1-44 of U.S. Patent No. 11,866,503 in view of Ardeleanu, Matsumoto and Clinical Trial NCT03387852 (cited previously).
The '503 patent claims a method for treating an inflammatory disease or disorder of the airway or lungs of a subject in need thereof, comprising administering one or more doses of a therapeutically effective amount of an interleukin-33 (IL-33) antagonist in combination with one or more doses of a therapeutically effective amount of an interleukin 4 receptor (IL-4R) antagonist, wherein the claimed antagonists are identical to the instantly claimed antibodies (claim 1).
The '503 patent further claims that the inflammatory disease or disorder may be asthma (claim 3) or eosinophilic asthma (claim 6).
However, the '503 patent does not teach the use of blood eosinophil count or periostin levels to select a patient.
Ardeleanu teaches "maintenance doses" of the above therapy, which are administered 2 weeks after the preceding dose (para. 0147-0148).
Ardeleanu further teaches that patients with eosinophilic asthma may have blood eosinophils greater than or equal to 300 cells/uL (para. 0013).
Ardeleanu further teaches that periostin levels are found to be up regulated in patients with asthma, and that IL-4R antagonists are useful in treating patients with elevated levels of periostin (para. 0158).
Ardeleanu further teaches that the background therapy may comprise an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA) (para. 0015), which is pertinent to claim 82.
Ardeleanu further teaches that the compositions in question may be administered with an autoinjector (para. 0132), which is pertinent to claim 84.
Matsumoto teaches that serum periostin is a strong predictor of airway eosinophilia in patients with severe asthma who remain symptomatic despite maximal ICS treatment (page 154, right column, second paragraph).
Matsumoto further teaches that a population of patients with asthma and an average age of 62.3 years had an average serum periostin level of 92.8 ng/mL, compared to a population of healthy subjects with an average serum periostin level of 39.1 ng/mL (page 154, right column, fourth and fifth paragraphs).
Clinical Trial NCT03387852 teaches a dosage schedule of SAR440340 and Dupilumab, administered every two weeks (page 4).
Clinical Trial NCT03387852 also teaches that the above treatment may have an effect on FEV1 (page 3).
Clinical Trial NCT03387852 teaches that the antibodies in question may be REGN3500 (i.e., SAR440340) and dupilumab (page 3), which is pertinent to claim 83.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the '503 patent with the teachings of Clinical Trial NCT03387852, Ardeleanu and Matsumoto to arrive at the claimed invention. The '503 patent teaches that combination therapies of an interleukin-33 (IL-33) antagonist and an interleukin-4 receptor (IL-4R) antagonist are useful in treating asthma. Ardeleanu teaches that patients with eosinophilic asthma may have blood eosinophils greater than or equal to 300 cell/uL, Matsumoto teaches that adult patients with asthma may have serum periostin levels of 92.8 ng/ml. Using the definitions from Ardeleanu and Matsumoto, a skilled artisan could select the appropriate patient population to apply the treatment plan of the '503 patent. All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods (e.g., applying a known therapy to a specific, defined patient population) with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
While the cited references do not explicitly teach the claimed dosage of the IL-33- binding antibody, determination of dosage is routinely determined by the ordinary artisan as of the effective filing date of the claimed invention, and was known as a result effective variable that depends on the conditions of the patients. 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) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). One of ordinary skill in the art would appreciate the amount or dosage of the antibody in the therapy could be adjusted to achieve optimum therapeutic efficacy. Applicant has not presented evidence of any unexpected criticality of the claimed dosage schedule.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/PETER JOHANSEN/Examiner, Art Unit 1644
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