DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2 Applicant's amendment, filed on 02/07/2024, is acknowledged.
3. Claims 43-51, 53-56 and 67-70 are pending.
4. Applicant’s IDS, filed 02/22/2024, is acknowledged.
5. The following is a quotation of 35 U.S.C. 112(b) (Pre AIA , 35 U.S.C. 112, second paragraph):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
6. Claims 45, 48, 48, 50-51 are rejected under 35 U.S.C. 112(b), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
(a) The phrase “the functional variant thereof” in claim 48 lack sufficient antecedent basis in base claim 47.
(b) The metes and bound of the term “about” in claims 45, 48, 48, 50-51, is not clear. Is the term “about” means plus or minus 1, 2 or 3 unit or more?
7. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
8. Claims 67-69 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating SLE or CLE with anifrolumab, does not reasonably provide enablement for methods of treating a broad genus of type I IFN mediated diseases with anifrolumab. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claims are directed to a broad genus of methods of treating type I IFN mediated disease with anifrolumab.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The specification discloses the present inventors have demonstrated that an anifrolumab dose of <150 mg Q and >105 mg QW will provide at least similar or even a higher Cave over 52 weeks to that of 300 mg IV Q4W. A 120 mg SC QW dose will particularly provide an efficacy at least equivalent to that demonstrated for a 300 mg IV Q4W dose. It is further plausibly demonstrated that a 120 mg SC QW dose will provide an efficacy greater than that demonstrated for a 300 mg IV Q4W dose [0185].
[0186] A dosing regimen of 900 mg anifrolumab IV Q4W for 6 doses followed by 120 mg anifrolumab SC QW was thus selected based on a combination of PK/PD data and modelling of data from the Phase II LN study (Study 7, see Section Error! Reference source not found.. and Error! Reference source not found.) and knowledge from the anifrolumab IV and SC clinical program in SLE as described Section 12.2. [0187] Study 07, assessed 2 dosing regimens: a basic regimen using the proposed dose for SLE patients (300 mg IV Q4W) and an intensified regimen, which commenced with 3 doses of 900 mg IV Q4W followed by 300 mg IV Q4W for the remainder of the study. The intensified regimen showed results suggesting a greater treatment benefit over the basic regimen.
[0188] However, the exposure in the initial phase 300 mg IV Q4W of both regimens was suboptimal when compared with the 300 mg IV Q4W dose in SLE without active renal disease. Therefore, a more intensive dosing regimen was selected, with an initial dose of 900 mg IV Q4W for 6 doses, followed by 120 mg SC QW. This regimen will provide sustained anifrolumab exposure/PD suppression and improved UPCR outcome compared with the previously evaluated dose regimens in study 07. The 120 mg SC QW dose will provide at least similar or non-inferior exposure and PD suppression to that of 300 mg IV Q4W in patients with SLE.
Besides treating SLE, any treatment using an anifrolumab is not yet known and has not yet been disclosed, therefore, the method is only potential because it is not currently available in practical form.
Regarding in vivo methods which rely on generally unpredictable mechanisms, ''The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.'' In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The "amount of guidance or direction'' refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling (MPEP 2164.03).'' The MPEP also states that physiological activity can be considered inherently unpredictable.
Further, in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297-1303 (CAFC 2005), the court states "If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to "inventions" consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the 'inventor' would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis."
The influence of a scientific theory should depend on its empirical and demonstrable aspects and not its underlying logic. Yet such empirical and demonstrable aspects of the claimed method of treating or preventing hypertensive end organ damage or complications of heart failure by inhibiting galectin-3 are lacked in the instant specification. No working empirical data demonstrating that by inhibiting anifrolumab would treat each and every type I IFN mediated disease. The skill in the art would doubt that the claimed mechanisms of inhibiting anifrolumab would treat each and every type I IFN mediated disease.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 43-51, 53-56 and 67-70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170051066/ US 10,125,195 B2.
The teachings of the `066 publication is identical to the teachings of the `195 patent, the `066 is used in the rejection.
The `066 publication teach the antibody formulations comprising unit dosage forms by preparing a pre-filled syringe (PFS) containing an aliquot of the aqueous antibody formulation for a one-time use. For example, a unit dosage per pre-filled syringe may contain 0.1 ml, 0.2 ml, 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml, 1 ml, 2 ml, 3 ml, 4 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, 10 ml, 15 ml, or 20 ml of different concentrations of an antibody or antigen binding fragment thereof that specifically binds to an IFNAR1 polypeptide ranging from about 140 mg/ml to about 160 mg/ml. The aqueous antibody formulations of the present invention are formulated into single dose pre-filled syringes (i.e., accessorized) as a sterile liquid that contains about 145 mg/mL to about 155 mg/mL of an antibody or antigen binding fragment thereof, wherein the antibody is anifrolumab, about 45 to 55 mM lysine HCl, about 0.04% to about 0.08% polysorbate-80, about 120 mM to about 140 mM trehalose (i.e., uncharged excipient), and about 20-30 mM histidine/histidine HCl. The aqueous antibody formulations of the present invention are formulated into single dose pre-filled syringes as a sterile liquid that contains about 145 mg/mL to about 155 mg/mL of an antibody or antigen binding fragment thereof, wherein the antibody wherein the antibody is anifrolumab, about 45 to 55 mM lysine HCl, about 0.04% to about 0.08% polysorbate-80, about 120 mM to about 140 mM trehalose, and about 20-30 mM histidine/histidine HCl. In embodiments, the pH of the formulation is about 6 [0115]. The 066 publication teaches prefilled syringes (PFS) (BD Hypak SCF 1MLL 27G1/2-SB) comprising MEDI-546 at 150 mg/mL in 25 mM histidine/histidineHCl, 50 mM lysine HCl, 130 mM trehalose dihydrate, 0.05% polysorbate 80, pH 5.9. [0153].
Table below shows the antibody formulation comprising unit dosage forms by a pre-filled syringe containing an aliquot of the aqueous antibody formulation for a one-time use comprising 108.5 mg, 112 mg, 116 mg, 124 mg, 128, mg, 126 mg, 130.5 mg, 139.5 mg, 140 mg, 144 mg and 145 mg of anifrolumab (Table 7, [0163]). Table 10 shows 135 mg/ml (i.e., 135 mg) and 150 mg/ml (i.e., 150 mg) of target antibody (anifrolumab).
The `066 publication claims a pre-filled syringe comprising: a. 150 mg/mL (i.e., 150 mg) anifrolumab; b. 50 mM lysine HCl; c. 130 mM trehalose dihydrate; d. 0.05% polysorbate 80; e. 25 mM histidine/histidine HCl wherein the formulation is at a pH of 5.9 (published claims 33, 77).
A stable antibody formulation comprising: a. about 100 mg/mL (100 mg) to about 200 mg/mL (200 mg) of an anti-IFNAR1 antibody or antigen-binding fragment thereof; b. about 25 to 130 mM of lysine or a lysine salt; c. an uncharged excipient; d. a surfactant; and e. a formulation buffer (published claim 1), wherein the lysine or lysine salt is in a concentration of about 50 mM, wherein the uncharged excipient is trehalose dihydrate (publication 21), wherein the formulation is an injectable formulation suitable for intravenous, subcutaneous, or intramuscular administration. (published claim 59).
The term “about” in the claim would open up the claim to include the recited dose plus or minus (±) ±1 mg, ±2 mg, ±3 mg, ± 4 mg or ± 5 mg.
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The `066 publication teaches methods of treating a type I IFN-mediated disease or disorder in a subject in need thereof, by administering a therapeutically effective amount of the antibody formulation described herein, wherein the type IFN-mediated disease is systemic lupus erythematosus [0111].
The reference teachings anticipate the claimed invention.
11. Claims 43, 49-51, 53-56 and 67-70 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20240158519.
The `519 publication teaches the patient is administered one or more fixed doses of anifrolumab, wherein the dose is 150 mg [0084]. Anifrolumab may be administered by accessorized pre-filled syringe (APFS) [8]. The APFS [8] includes the unit dose of anifrolumab [6] contained in a primary container [9] shown in an assembled state in FIG. 19A and in an exploded view in FIG. 19B. The primary container [9] has a plunger stopper [16]. The primary container has a nominal fill volume [17] of 0.8 ml but may contain slightly more than 0.8 ml. The remainder of the space in the primary container [9] is taken up by an air bubble [18] [0194] .
The `519 teaches The data further show that treatment of patients suffering from a type I IFN mediated disease (e.g. SLE) with an inhibitor of type I IFN signalling (e.g. anifrolumab) treats cardiovascular disease in these patients [0011], [0070] .
The reference teachings anticipate the claimed invention.
12. 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.
13. Claims 43-51, 53-56 and 67-70 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150158949 A1 in view of Tummamala et al (lupus Sci Med. 2018 <ar 23, e000252, IDS).
The `949 publication teaches clinical indications to SLE for a Phase 2 trial, a translational model was developed that incorporated (1) the pharmacokinetics (PK) and pharmacodynamics (PD) of MEDI-546 (aka anifrolumab) in SSc patients, (2) the internalization kinetics of the MEDI-546/IFNAR complex as determined from confocal imaging studies, and (3) the magnitude of differences in the type I IFN GS in blood and skin between SSc and SLE patients. This model was first used to characterize the disposition properties of MEDI-546 and the suppression of the type I IFN signature in SSc patients, for which clinical data was available. Afterwards, the PK/PD model was adjusted to account for the magnitude of differences in the type I IFN GS between SSc and SLE patients, and stochastic PK-PD simulations were performed to predict type I IFN GS responses in blood and skin specimens upon multiple MEDI-546 administrations in virtual SLE patients. This approach facilitated a rapid progression of MEDI-546 clinical development and the optimal design of a Phase 2 study in SLE. Stochastic simulations predicted that once-every-four-week intravenous administrations of MEDI-546 at 100 mg, 300 mg or 1000 mg fixed doses could suppress the type I IFN GS in the blood of SLE patients to the level of healthy normal subjects (mean.+-.2 standard) [0106].
[0115] An antibody or antibody fragment thereof that modulates type I IFN activity is administered as a fixed dose ranging from about 100 mg to about 1000 mg. The fixed dose is lower than about 300 mg. The antibody or antibody fragment thereof that modulates type I IFN activity is MEDI-546.
[0120] The fixed dose of antibody or antibody fragment thereof that modulates type I IFN activity is a 100 mg dose administered monthly. The fixed dose of antibody or antibody fragment thereof that modulates type I IFN activity is a 100 mg, 300 mg, or 1000 mg monthly dose of MEDI-546.
[0124] The disclosure provides a method of treating a type I IFN-mediated disease or disorder, such as an autoimmune disorder (e.g., SLE) in a patient comprising administering at least one intravenous or subcutaneous fixed dose of an anti-IFNAR antibody such as MEDI-546 to the patient, wherein the fixed dose is about 100 mg, about 300 mg, or about 1000 mg.
[0133] The antibody or antigen-binding fragment thereof that modulates type I IFN activity, e.g., an anti-IFNAR antibody such as MEDI-546 can neutralize the type I IFN GS at fixed doses of about 100 mg, about 300 mg, or about 1000 mg [0133].
The reference teachings differs from the claimed invention only in the recitation that of a unit dose form comprising >105 mg and ≥ 150 mg anifrolumab in claim 53, ≤ 135 mg in claims 44 and 47, about 120 mg in claims 45 and 48, >105 mg and <150 mg in claim 46, about 150 mg/ml in claim 49,
Tummamala teaches this placebo-controlled study is assessing two fixed dosages of anifrolumab (150 mg and 300 mg) administered subcutaneously every 2 weeks for up to 50 weeks, within a treatment period of 52 weeks. The objective of the study is to identify the most appropriate SC dosage for a future Phase III trial (page 5, 1st ¶).
One of skill in the art would have had ample reason to use routine experimentation to determine optimum dosing. One skilled in the art would have been motivated to examine doses between 105 mg and 150 mg that falls within range taught by `949 publication. One of skill in the art would have had a reasonable expectation of success in determining therapeutically effective doses in the treatment of SLE.
It would have been obvious to one of ordinary skill in the art before the effective filing date of Applicants' invention was made to determine all operable and optimal concentrations of components because concentration is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Further, the determination of the optimal dosage and the duration of treatment is well within the purview of one of ordinary skill in the art at the time the invention was made and lends no patentable import to the claimed invention. 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. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II.
Where there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness. But the presumption will be rebutted if it can be shown: (1) That the prior art taught away from the claimed invention, In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997); or (2) that there are new and unexpected results relative to the prior art, In re Woodruff, 919 F.2d, 1575, 1578 (Fed. Cir. 1990). The CAFC discussed In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), in In re Harris, 409, F.3d 1339 (Fed. Cir. 2005), and held that the claimed ranges overlapped the ranges disclosed in a prior art reference and thus were prima facie obvious.
"[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence" of teaching away, unexpected results, or other pertinent evidence of nonobviousness. Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013).
The Board stated that "all that remained to be achieved over the prior art was the determination that a specific dose within a previously suggested dose range, and its corresponding dosing schedule, would have been safe and effective for the treatment of human patients." Genzyme Therapeutic Prods. v. Biomarin Pharms., No. 2015-1720.
The experimentation needed to arrive at the subject matter claimed was “nothing more than routine” application of a well-known problem-solving strategy, we must conclude it is not inventive. Pfizer, Inc. v. Apotex, Inc., 480 F3d 1348, 1368 (Fed. Cir. 2007).
"[I]t is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955); see also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). "Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range." In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). "[D]iscovery 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 (CCPA 1980).
“It is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1995); see also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). “Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range.” In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1997)). “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 (CCPA 1980). Applicant’s claims and arguments fail under these tests.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
14. 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.
15. Claims 43-51, 53-56 and 67-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12060429. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `429 patent claims methods of treating type I interferon (IFN)-mediated disease in a subject comprising subcutaneously administering a unit dose comprising 120 mg to 135 mg of a type I interferon (IFN) receptor (IFNAR1) inhibitor, wherein the IFNAR1 inhibitor is anifrolumab and wherein the unit dose is for subcutaneous injection once per week (QW) to the subject in need thereof, wherein the disease is an autoimmune disease, wherein the disease is lupus, wherein the disease is systemic lupus erythematosus (SLE), wherein the disease is moderate to severe, active autoantibody-positive SLE, wherein the disease is lupus nephritis (LN), wherein the disease is cutaneous lupus erythematosus (CLE), wherein the disease is myositis, wherein the disease is scleroderma, wherein the unit dose comprises 120 mg of anifrolumab. The claims of the `429 anticipate instant claims 43-48 and 67-70 and renders claims 49-56 obvious because the specification of the `429 teaches PFS and APFS for anifrolumab.
16. Claims 43-51, 53-56 and 67-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10125195 B2 and optionally in view of US 12060429. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `195 patent claims antibody formulations comprising: a. 150 mg/mL anifrolumab; b. 50 mM lysine HCl; c. 130 mM trehalose dihydrate; d. 0.05% polysorbate 80; e. 25 mM histidine/histidine HCl, wherein the formulation is at a pH of 5.9, wherein the formulation is an injectable formulation suitable for intravenous, subcutaneous, or intramuscular administration. A pre-filled syringe comprising: a. 150 mg/mL anifrolumab; b. 50 mM lysine HCl; c. 130 mM trehalose dihydrate; d. 0.05% polysorbate 80; e. 25 mM histidine/histidine HCl wherein the formulation is at a pH of 5.9.
The claims of the `195 patent do not claim method for treating SLE with the anifrolumab.
The teachings of the `429 have been discussed, supra.
It would have been obvious to target SLE with the composition taught by `195 patent because the dosage taught in the `429 patent and in `195 paten are considered effective in the SLE treatment.
The Board stated that "all that remained to be achieved over the prior art was the determination that a specific dose within a previously suggested dose range, and its corresponding dosing schedule, would have been safe and effective for the treatment of human patients." Genzyme Therapeutic Prods. v. Biomarin Pharms., No. 2015-1720.
"[I]t is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955); see also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). "Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range." In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). "[D]iscovery 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 (CCPA 1980).
The experimentation needed to arrive at the subject matter claimed was "nothing more than routine" application of a well-known problem-solving strategy, we must conclude it is not invention. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007).
An improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“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). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05IIA on this issue.
The claimed specific doses are not drastically different from, but rather overlaps, the range of about 105-150 mg.
The claims of the `195 patent renders the instant claims obvious.
17. Claims 43-51, 53-56 and 67-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 108-112 of copending Application No. 18665297 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `297 application claims an injection device comprising a unit dose, wherein the unit dose comprises more than (>)105 mg and less than (<)150 mg of a type I IFN receptor (IFNAR1) inhibitor, wherein the IFNAR1 inhibitor is anifrolumab, comprising equal to or less than (<)135 mg of the IFNAR1 inhibitor, comprising about 120 mg of the IFNAR1 inhibitor, wherein the injection device is a pre-filled syringe (PFS), wherein the injection device is an auto- injector.
The claims of the `297 application anticipate the instant claims 43-51 and 53-56 and render instant claims 67-70 obvious because the specification of the `197 application discloses the use of the claimed antibody formulation in the treatment of SLE.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18. Claims 43-51, 53-56 and 67-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 13-18, 20, 27-28, 34-40, and 53 of copending Application No. 18698343 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `343 application claims methods of treating pain in a subject having SLE with anifrolumab, wherein the method comprises administering a fixed dose of anifrolumab, the method comprising administering anifrolumab er the functional variant thereof to the patient at a dose of greater than 105 mg and less than 150 mg, comprising administering anifrolumab er the functional variant thereof to the patient at a dose of about 120 mg per week, wherein anifrolumab is administered subcutaneously.
The claims of the `343 application anticipate the instant claims, it would be obvious to include the antibody formulation in PFS or AFPS.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19. Claims 43-51, 53-56 and 67-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 8, 9, 17, 19, 20, 72-74 of copending Application No. 18556733 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `733 application claims methods of treind lupus nephritis in a subject with anifrolumab comprsiign administering subcutaneously a subcutaneous does is greater than (>) 105 mg and less than (<) 150 mg, wherein the subcutaneous dose is ≤ 135 mg, is about 120 mg. The `733 application also claims a unit dose comprising >105 mg and ≤150 mg anifrolumab, comprising ≤135 mg anifrolumab or about 120 mg anifrolumab,
The claims of the `733 application anticipate the instant claims, it would be obvious to include the antibody formulation in PFS or AFPS and to treat SLE.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
20. Claims 43-51, 53-56 and 67-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 20, 22-24, and 33-36 of copending Application No. 18248280 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `280 application claims methods of treating systemic lupus erythematosus(SLE) in a patient thereof, the method comprising administering anifrolumab, wherein the method comprises administering a fixed dose of anifrolumab, comprising administering anifrolumab or the functional variant thereof to the patient at a dose of 120 mg every week, optionally wherein anifrolumab or the functional variant thereof is administered subcutaneously.
The claims of the `280 application anticipate the instant claims, it would be obvious to include the antibody formulation in PFS or AFPS.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
21. Claims 43-51, 53-56 and 67-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 22-41 of copending Application No. 19117553 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `553 application claims methods for treating systemic lupus erythematosus (SLE) with anifrolumab, wherein the IFNAR1 inhibitor is administered to the subject at a dose of 120 mg to 1000 mg, wherein the IFNAR1 inhibitor is administered to the subject subcutaneously at a dose of about 120 mg every week. The `553 also claims injection device such as PFS, AFPS or auto-injector. The claims of the `553 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
22. Claims 43-51, 53-56 and 67-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-22, 33-46 of copending Application No. 18291671 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `671 application claims methods for treating systemic lupus erythematosus (SLE) with anifrolumab, wherein the composition comprises >105 mg and < 150 mg anifrolumab, or ≤ 135 mg anifrolum, or 120 mg anifrolumab,, the composition has a volum of about 0.5 to about 1 mg or about 0.8 ml. The `671 also claims injection device such as PFS, AFPS or auto-injector. The claims of the `671application anticipate the instant claims.
The `553 also claims injection device such as PFS, AFPS or auto-injector.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
23. Claims 43-51, 53-56 and 67-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 113-116, 118-120, 123- 132, 149, 151, 152, and 154-156 of copending Application No. 17660340 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the `340 application claims method of treating lupus nephritis (LN) in a subject in need thereof, the method comprising administering a huma n monoclonal antibody that specifically binds IFNAR1 which is anifrolumab, comprising administering subcutaneously a subcutaneous dose of the human monoclonal antibody that specifically binds IFNAR1 of greater than (>)105 mg and less than (<)150 mg. The `340 application claims the second dose is about 120 mg and is administered subcutaneously every week (QW).
The `340 also claims injection device such as PFS, AFPS or auto-injector.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
24. No claim is allowed.
25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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June 16, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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