DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 20, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 20, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Claim Status
Claims 47-54, 60-71, 77-84, 88, 90-91, and new claim 92 are under consideration in this office action.
New Objections/Rejections
Claim Objections
New claim 92 is objected to because of the following informalities: in line 2, there is a colon missing after “SEQ ID NO”. Appropriate correction is required.
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.
Claims 47-54, 60-69, 71, 77 and new claim 92 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0258176 published September 13, 2018 (“van Eenennaam”; PTO-892 from March 31, 2023) in view of WO 2019/214707 published November 14, 2019 (“Wang”; PTO-892 from September 23, 2022) and Whitaker et al, published June 28, 2017 (instant PTO-892).
van Eenennaam teaches a pharmaceutical formulation for an anti-APRIL antibody. To prepare the pharmaceutical composition, the antibody is mixed with physiologically and pharmaceutically acceptable carriers, excipients, and stabilizers in the form of, for example, an aqueous solution [0142], as in instant claim 47. van Eenennaam teaches a human anti-APRIL antibody of heavy chain variable region/light chain variable region pair SEQ ID NO: 40/SEQ ID NO: 30 [0051], which is identical to VH/VL pair of SEQ ID NO: 24/SEQ ID NO: 26, as in instant claim 47.
Regarding new claim 92, van Eenennaam teaches an anti-APRIL antibody comprised of a heavy chain of SEQ iD NO: 52 and a light chain of SEQ ID NO: 50 [0058], which are identical to the instantly claimed anti-APRIL antibody of heavy chain of SEQ ID NO: 28 and light chain of SEQ ID NO: 30.
van Eenennaam teaches that suitable routes of administration for the pharmaceutical composition are intravenous and subcutaneous administration [0144], as required by instant claim 48. Subcutaneous injections are commonly given in the thigh, abdomen, or upper arm, as required by claim 69. Also, van Eenennaam teaches that the antibodies of the invention may be beneficial for diseases associated with Ig deposition including IgA nephropathy and treatment with the anti-APRIL antibody [0079-80], as in the method of treating IgA nephropathy of instant claim 61.
With respect to dosing, van Eenennaam teaches a “preferred dose protocol” that involves the maximal dose or dose frequency that avoids significant undesirable side effects; these injections are given weekly as in instant claim 63. A total weekly dose is most typically at least 0.1 mg/kg and most optimally at least 50 mg/kg [0148]. Weight based dosing can be converted to a flat dose using a conversion factor of 80, as the median body weight for adults is approximately 80 kg, as evidenced by Walpole et al (PTO-892 from 8/14/24). The weight-based dose of van Eenannaam (0.1 mg/kg-50 mg/kg), when converted to a flat dose is 8-4000 mg, which includes the dose range of instant claim 66. Since the antibody formulation of instant claims 67-68 is comprised of 150 mg/ml anti-APRIL antibody, it follows that each dosing event would include volumes of 2 or 4 ml, which would be 300 or 600 mg antibody, as required by the injection volumes claims 67-68.
As stated by van Eenennaam, “Guidance in selecting appropriate doses of antibodies, cytokines, and small molecules are available” [0146] and “determination of the appropriate dose is made by the clinician, using parameters or factors known or suspected in the art to affect treatment or predicted to affect treatment” [0147]. Thus, the administration protocol/method of the instant application as applied to the anti-APRIL antibody would have already been well known in the art at the time the invention was filed.
Van Eenennaam teaches composition comprising the antibody in combination with a pharmaceutically acceptable carrier or diluent [0071]; the anti-APRIL antibody is admixed with a pharmaceutically acceptable carrier or excipient, as exemplified by Remington’s Pharmaceutical Sciences and U.S. Pharmacopeia: National Formulary, Mack Publishing Company, Easton, Pa (1984) [0142]. van Eenennaam, however, does not specifically exemplify the histidine buffer, arginine viscosity reducer, polysorbate co-solvent, sugar stabilizer (e.g., sorbitol), and pH 6.0-6.6 of instant claim 47; nor does it disclose the specific concentrations of antibody, buffer, polysorbate 20, or sorbitol, the osmolality, the viscosity, and the optical density of the formulation. However, these ingredients and parameters were used by those skilled in the art to prepare and evaluate formulations for human administration at the time the invention was filed, as illustrated by Wang, who teaches a liquid pharmaceutical preparation comprising antibodies (e.g., anti-PCSK9) and therapeutic uses of such preparations [0001].
Wang teaches a stable liquid formulation for pharmaceutical treatment comprising a monoclonal antibody [0184].
The reference teaches a liquid pharmaceutical composition comprising [0035-0040]:
An antibody at concentrations of 100-200 mg/ml (vs instantly recited 20-190 mg/ml of claim 47, 150 mg/ml of claims 51, 60, and 71)
Histidine at concentrations of 0.2-10 mg/ml (i.e. 1.29-64.45 mM) at pH 5-6 (vs instantly recited 10 mM histidine at pH 6.1-6.3 of claim 47, 58-60, 75-77, and 89 and pH of 6.1 of claim 88
Arginine at concentrations of 50-180 mM (vs instantly recited 75 mM arginine of claim 47, 60, 77, and 91)
Sorbitol at concentrations of 1-6% (vs instantly recited 3% sorbitol of claim 47, 60, 77, and 90-91)
Polysorbate 20 at concentrations of 0.05-1 mg/ml (i.e. 0.005-.1%) (vs instantly recited 0.01% polysorbate 20 of claims 47, 60, 77, and 90-91)
This pharmaceutical formulation taught by Wang has a viscosity of about 1-20 cP [0026] and is not comprised of glutamic acid or its salt, glycine, carbonate, HEPES, phosphate, citrate, or acetate, as in instant claims 47 and 54. Although the formulation of Wang does not explicitly exclude these excipients from the formulation, the formulation of Wang does not contain these excipients.
The calculated osmolality of a preferable embodiment of the pharmaceutical composition of Wang [0056] is approximately 264 mOsmol [90 mM arginine + 164 mM sorbitol + 10 mM histidine + (< 1 mM) polysorbate 20 + (< 1 mM) antibody] (vs instantly recited 250-390 mOsm/kg), which teaches the osmolality of instant claims 47 and 52.
An OD330 of less than 1.0, as recited in claims 47 and 53, is expected for the formulation of Wang as well because these formulations are the same, comprising overlapping concentrations of the same excipients, surfactants, and stabilizers and are optimized for limiting antibody aggregation.
Wang teaches a liquid formulation of the antibody stored at about -80°C -45°C for 14 days to 36 months; criteria for stability included, typically, no more than about +/-10% change, preferably about 5% or less [0043], which teaches the stability of the pharmaceutical composition of instant claims 49-50.
Wang teaches that the structure of the monoclonal antibody is very complex, and during production these molecules can undergo various post-translational modifications and degradation reactions [0006]. These include N-terminal cyclization, glycosylation, deamidation, isomerization, oxidation, fragmentation, disulfide bond mismatch, etc.; these modifications can affect the effectiveness and safety of the final product [0006]. In addition, there is a need to provide liquid formulations at high antibody concentrations (> 100 mg/ml) to meet clinical dosage requirements [0005]. Challenges related to generating high concentration antibody formulations include high viscosity, poor stability, production of aggregates and particles, and change in protein conformation, which can change charge heterogeneity [0005]. There is a need in the art to provide liquid formulations that would be applied to any monoclonal pharmaceutical antibody.
As taught by Wang, the instant formulation of claim 47 comprises components that are routinely used and are at concentrations that are typical of those routinely used in the art for preparation of liquid pharmaceutical antibody formulations. The art teaches concentrations that fall squarely within the claimed range, and there is no evidence of criticality [0008]. Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to select the recited excipients, surfactants, and stabilizers of Wang and adjust their concentrations as needed to produce a stable pharmaceutical formulation of the anti-APRIL antibody of van Eenennaam.
These teachings of Wang, as argued by applicant in the Remarks filed 1/20/2026, fail to address substantively why one of ordinary skill in the art would have used the antibody formulation of Wang, which is for a different antibody, with the anti-APRIL antibody of van Eenennaam. As taught by Whitaker et al, high antibody concentration formulations are required for subcutaneous administration, but these high concentration formulations are associated with increased viscosity, which can lead to delivery and stability challenges (abstract). In an effort to identify approved excipients to reduce viscosity, Whitaker et al developed a screening method of different excipients for high concentration antibody formulations (abstract). In total, 56 FDA-approved additives were screened, including salts, polyols, alcohols, sugars, detergents, proteins, amino acids, and polymers, and the effects on the viscosity and stability of two monoclonal antibodies were examined (pg 3232, column 2). Thus, Whitaker et al demonstrate that the ordinary artisan was aware of the criteria that determine successful development of a high-concentration antibody formulation and that the particular combination of excipients for a given antibody and the needs thereof can be determined by methods already known in the art. The generalized formulation development approach and workflow outlined in Whitaker et al is applicable to the rapid, empirical approach to the high concentration formulation development of many mAbs (pg 3240, column 2).
Because Whitaker et al teach a systemic approach to develop concentrated antibody formulatiosn with acceptable viscosities and stabilities (pg 3240, column 2), the ordinary artisan would have been able to generate the claimed formulation and have a reasonable expectation of successfully generating an antibody formulation with the desired viscosity, osmolality, optical density, and stability.
Wang and Whitaker et al demonstrate that not only were the criteria for high-concentration antibody formulation known in the art, it was known that these criteria had been met for several other antibodies. Given the combined teachings of van Eenennaam, Wang and Whitaker et al, the ordinary artisan would have reasonably expected to have identified the concentrations of the excipients as identified in Wang. The identification of these concentrations could have been achieved through routine optimization because the concentrations of the excipients and antibody and the formulation pH are result-effective variables, which can be routinely determine and optimized in the pharmaceutical arts. It would have been routine for a person of ordinary skill in the art to verify the expectation of viscosity at the specific concentration of antibody using in the screening method of Whitaker et al within the previously taught ranges of Wang and Whitaker et al. Indeed, Whitaker also teaches formulations comprised of arginine, histidine, sorbitol, and polysorbate 20, demonstrating that the claimed formulation of the same excipients were sufficiently described in the prior 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. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP §§ 2144.05 part II.A. The determination of the exact doses in view of the patient’s conditions is well within the skill of those skilled artisans. Further, 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). It would be conventional and within the skill of the art to identify the excipients at the claimed concentrations.
When other methods similar to a claimed method have been successful, the court has determined there would have been a reasonable expectation of success. For example, in Velander v. Garner, 348 F.3d 1359, 1379 (Fed. Cir. 2003), a reasonable expectation of success was found for a method of producing a particular protein when several other proteins had been produced in a similar way. Thus, when applying the known method of Whitaker et al to the antibody of van Eenennaam, the formulation is obvious.
Regarding treatment dose and dosing schedule in a method of treating a subject with IgA nephropathy, a skilled person in the art would attempt to identify the optimal treatment dosing schedule for a monoclonal antibody when used as a monotherapy and would adjust accordingly to reach the optimum dosing strategy. In this case, an artisan prior to the effective filing date of the claimed invention would have a reason to vary the dose and cycle times (whether they be every 1 week, 2 weeks, or 4 weeks) of the anti-APRIL antibody (using the general guidance of Wang and van Eenennaam) because both were recognized as results-effective variables in the field of immunotherapy. Thus, one of ordinary skill in the art would have had a reasonable and predictable expectation of arriving at the claimed dosing regimens detailed in claims 64-65.
The ordinary artisan at the time the invention was made would have been motivated to combine the teachings of van Eenennaam and Wang, in view of the art-recognized need to generate stable high concentration antibody formulations. The formulation of Wang, including the concentrations of buffers, stabilizers, and surfactants, provides stability of high monoclonal antibody formulations. Thus, one would have a reasonable expectation of success, based on the knowledge and skill in the art and in view of the routine nature of the experimentation involved, that using the formulation of Wang with the anti-APRIL antibody of van Eenennaam would provide a stable and quality formulation necessary to maintain the bioactivity of the anti-APRIL antibody during long-term storage. All sequences of the anti-APRIL antibody in the instant claims are taught by van Eenennaam, and the formulation of the instant claims overlap with that of Wang and Whitaker et al. Therefore, it would be expected, absent evidence to the contrary, that providing the antibody of van Eenennaam in the formulation of Wang and Whitaker et al would provide the stability necessary for storage for the anti-APRIL antibody.
Thus, the prior art references as combined provide a prima facie case of obviousness over the instant claims, absent convincing evidence to the contrary. MPEP 2144.05 states that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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).
Claims 47-54, 60-69, 71, 77-84, 88, 90-91 and new claim 92 are rejected under 35 U.S.C. 103 as being unpatentable over van Eenennaam in view of Wang and Whitaker et al, as applied to claims 47-54, 60-69, 71, 77 and 92 above, and further in view of US 2019/0169299 (“Amin”, published June 6, 2019; PTO-892 from September 23, 2022).
Together, van Eenennaam, Wang, and Whitaker et al teach the anti-APRIL antibody formulation for infusion, dosage strategy, and method for treatment of IgA nephropathy of instant claims 83-91; but they do not teach a loading/maintenance dose administration protocol.
Amin teaches methods of treatment by administering a therapeutic composition comprised of an antibody. The antibody is formulated in a composition comprising about 150 mg/ml [0256] of antibody, as in instant claims 84 and 90.
With respect to claims 78-84, 88, and 90-91, Amin teaches a method comprising administering to a subject in need a loading dose or an antibody and administering to the subject a plurality of maintenance doses during the treatment phase [0008]; the pharmaceutical composition can be delivered subcutaneously or intravenously [0176]. The loading dose is 600 mg, and the maintenance dose is 300 mg [0014], as in the limitation of instant claim 79 wherein the loading dose is administered at a higher concentration relative to the maintenance dose. The antibody can be administered every 2 or 4 weeks [0024]. Administration may be intravenous or subcutaneous [0176], as in instant claims 81-82.
Given that van Eenennaam, Wang, Whitaker et al, and Amin are drawn to monoclonal antibody treatments and further given that Amin discloses reliable methods for the treatment of disease using a pharmacological composition comprising a monoclonal antibody, it would have been obvious to one of ordinary skill in the art to combine the method of Amin with the combined method of van Eenennaam, Wang, and Whitaker et al to conceive a method of administering a monoclonal antibody at an initial loading dose and subsequent maintenance doses. Although limitations regarding dosing interval and route of administration for loading and maintenance doses are taught by Amin, Amin does not explicitly address different dosing intervals and routes of administration for loading doses and maintenance doses. However, an ordinary artisan prior to the effective filing date of the claimed invention would have a reason to vary the cycle times of the anti-APRIL antibody of van Eenennaam in the loading/maintenance dose protocol of Amin because dosing interval is recognized as results-effective variables in the field of monoclonal antibody therapy. Further, intravenous and subcutaneous routes of administration are taught by van Eenennaam and Amin, and without evidence to the contrary, the ordinary artisan would have a reasonable expectation of successfully administering a loading dose intravenously and a maintenance dose subcutaneously of the anti-APRIL antibody for the treatment of IgA nephropathy.
Claims 47-54, 60-71, 77, and new claim 92 are rejected under 35 U.S.C. 103 as being unpatentable over van Eenennaam in view of Wang and Whitaker et al, as applied to claims 47-54, 60-69, 71, 77 and 92 above, and further in view of Maeda (J Clin Lab Anal, 2003; PTO-892 from September 23, 2022).
The combination of van Eenennaam, Wang, and Whitaker et al teaches a pharmaceutical composition and treatment method for a disease with elevated levels of IgA; they do not teach a method for treating disease in a subject based on the level of serum IgA.
Maeda teaches a diagnostic analysis of patients with IgA nephropathy; one of four identified clinical markers of IgA nephropathy is a serum IgA level greater than 315 mg/dl (i.e. 3.15 mg/ml) (Abstract) as in claims 61 and 70. Patients with levels above 315 mg/ml exhibit a poor prognosis. The advantages of using this cutoff are diagnosis IgA nephropathy without renal biopsy (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art to use a threshold approximating an existing clinical marker in the literature for IgA nephropathy of instant claim 70 because this marker is known to be easily obtained from serum and can identify which patients are likely to benefit from the pharmaceutical composition of instant claim 47, which is taught by Eenennaam in view of Wang, as discussed above.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 47-54, 60-71, 77-84, 88, and 90-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,969,808 in view of US 2018/0258176 (“van Eenennaam), WO 2019/214707 (“Wang”), Whitaker et al, US 2019/0169299 (“Amin”), and Maeda. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to overlapping embodiments: a pharmaceutical formulation comprising anti-APRIL antibodies.
Claims 1-2 of ‘808 recite anti-APRIL antibodies and a composition comprising an anti-APRIL antibody and a pharmaceutically acceptable carrier or diluent. The anti-APRIL antibody of ‘808 of VH14_1G/VL15 is identical to the anti-APRIL antibody HCVR/LCVR pair of instant SEQ ID NO: 24/SEQ ID NO: 26 of instant claim 47 and 92.
van Eenennaam teaches a pharmaceutical formulation for an anti-APRIL antibody. To prepare the pharmaceutical composition, the antibody is mixed with physiologically and pharmaceutically acceptable carriers, excipients, and stabilizers in the form of, for example, an aqueous solution [0142], as in instant claim 47. van Eenennaam teaches a human anti-APRIL antibody of heavy chain variable region/light chain variable region pair SEQ ID NO: 40/SEQ ID NO: 30 [0051], which is identical to VH/VL pair of SEQ ID NO: 24/SEQ ID NO: 26, as in instant claim 47.
Regarding new claim 92, van Eenennaam teaches an anti-APRIL antibody comprised of a heavy chain of SEQ ID NO: 52 and a light chain of SEQ ID NO: 50 [0058], which are identical to the instantly claimed anti-APRIL antibody of heavy chain of SEQ ID NO: 28 and light chain of SEQ ID NO: 30.
van Eenennaam teaches that suitable routes of administration for the pharmaceutical composition are intravenous and subcutaneous administration [0144], as required by instant claim 48. Subcutaneous injections are commonly given in the thigh, abdomen, or upper arm, as required by claim 69. Also, van Eenennaam teaches that the antibodies of the invention may be beneficial for diseases associated with Ig deposition including IgA nephropathy and treatment with the anti-APRIL antibody [0079-80], as in the method of treating IgA nephropathy of instant claim 61.
With respect to dosing, van Eenennaam teaches a “preferred dose protocol” that involves the maximal dose or dose frequency that avoids significant undesirable side effects; these injections are given weekly as in instant claim 63. A total weekly dose is most typically at least 0.1 mg/kg and most optimally at least 50 mg/kg [0148]. Weight based dosing can be converted to a flat dose using a conversion factor of 80, as the median body weight for adults is approximately 80 kg, as evidenced by Walpole et al (PTO-892 from 8/14/24). The weight-based dose of van Eenannaam (0.1 mg/kg-50 mg/kg), when converted to a flat dose is 8-4000 mg, which includes the dose range of instant claim 66. Since the antibody formulation of instant claims 67-68 is comprised of 150 mg/ml anti-APRIL antibody, it follows that each dosing event would include volumes of 2 or 4 ml, which would be 300 or 600 mg antibody, as required by the injection volumes claims 67-68.
As stated by van Eenennaam, “Guidance in selecting appropriate doses of antibodies, cytokines, and small molecules are available” [0146] and “determination of the appropriate dose is made by the clinician, using parameters or factors known or suspected in the art to affect treatment or predicted to affect treatment” [0147]. Thus, the administration protocol/method of the instant application as applied to the anti-APRIL antibody would have already been well known in the art at the time the invention was filed.
Van Eenennaam teaches composition comprising the antibody in combination with a pharmaceutically acceptable carrier or diluent [0071]; the anti-APRIL antibody is admixed with a pharmaceutically acceptable carrier or excipient, as exemplified by Remington’s Pharmaceutical Sciences and U.S. Pharmacopeia: National Formulary, Mack Publishing Company, Easton, Pa (1984) [0142]. van Eenennaam, however, does not specifically exemplify the histidine buffer, arginine viscosity reducer, polysorbate co-solvent, sugar stabilizer (e.g., sorbitol), and pH 6.0-6.6 of instant claim 47; nor does it disclose the specific concentrations of antibody, buffer, polysorbate 20, or sorbitol, the osmolality, the viscosity, and the optical density of the formulation. However, these ingredients and parameters were used by those skilled in the art to prepare and evaluate formulations for human administration at the time the invention was filed, as illustrated by Wang, who teaches a liquid pharmaceutical preparation comprising antibodies (e.g., anti-PCSK9) and therapeutic uses of such preparations [0001].
Neither do the ‘808 claims nor van Eenennaam specifically exemplify the histidine buffer, arginine viscosity reducer, polysorbate co-solvent, sugar stabilizer (e.g., sorbitol), and pH 6.0-6.6 of instant claim 47. Nor do they disclose the specific concentrations of antibody, buffer, polysorbate 20, or sorbitol, the osmolality, the viscosity, and the optical density of the formulation. However, these ingredients and parameters were used by those skilled in the art to prepare and evaluate formulations for human administration at the time the invention was made, as illustrated by Wang and Whitaker et al, who teach liquid pharmaceutical preparation comprising antibodies and therapeutic uses of such preparations.
Therefore, it would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the dosing of ‘808 in view of Wang to arrive at the dosage and administration sequence of the instant claims. The Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. The dose ranges of Wang encompass the doses of the instant claims. MPEP 2144.05 states that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In addition, MPEP 2144.05 states that “generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). Medical professionals would be motivated to optimize the dosing amount, dosing types, and dosing schedule from the ranges and timeframes provided in Brown to achieve maximum therapeutic efficacy with minimal dosing to reduce cost and side effects. The determination of dosing that would allow the antibody to provide maximum treatment of the patient being treated, while minimizing side effects, in requires only routine experimentation for one of ordinary skill in the art. Therefore, given that the antibody and method of treatment have been previously described, without specific evidence that the indicated dose amounts and dose schedules are critical to the method, the identification of these properties will not render the subject matter patentable.
Amin teaches methods of treatment by administering a therapeutic composition comprised of an antibody. The antibody is formulated in a composition comprising about 150 mg/ml [0256] of antibody, as in instant claims 84 and 90.
With respect to claims 78-84, 88, and 90-91, Amin teaches a method comprising administering to a subject in need a loading dose or an antibody and administering to the subject a plurality of maintenance doses during the treatment phase [0008]; the pharmaceutical composition can be delivered subcutaneously or intravenously [0176]. The loading dose is 600 mg, and the maintenance dose is 300 mg [0014], as in the limitation of instant claim 79 wherein the loading dose is administered at a higher concentration relative to the maintenance dose. The antibody can be administered every 2 or 4 weeks [0024]. Administration may be intravenous or subcutaneous [0176], as in instant claims 81-82.
Given that ‘808, Wang, Whitaker et al, and Amin are drawn to monoclonal antibody treatments and further given that Amin discloses reliable methods for the treatment of disease using a pharmacological composition comprising a monoclonal antibody, it would have been obvious to one of ordinary skill in the art to combine the method of Amin with the combined method of ‘808, Wang, and Whitaker et al to conceive a method of administering a monoclonal antibody at an initial loading dose and subsequent maintenance doses.
The ’808 claims do teach a method for treating in a subject based on the level of serum IgA. Maeda teaches a diagnostic analysis of patients with IgA nephropathy; one of four identified clinical markers of IgA nephropathy is a serum IgA level greater than 315 mg/dl (i.e. 3.15 mg/ml) (Abstract) as in claim 43. Patients with levels above 315 mg/ml exhibit a poor prognosis. The advantages of using this cutoff are diagnosis IgA nephropathy without renal biopsy (Abstract). It would have been obvious to one of ordinary skill in the art to use a threshold approximating an existing clinical marker in the literature for IgA nephropathy of instant claim 70 because this marker is known to be easily obtained from serum and can identify which patients are likely to benefit from the pharmaceutical composition of instant claim 47, which is taught ‘808 in view of Wang, as discussed above.
Claims 47-54, 60-71, 77-84, 88, and 90-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,961,316 in view of Wang, Whitaker et al, US 2019/0169299 (“Amin”), and Maeda. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to overlapping embodiments: the same anti-APRIL antibody.
Claims 1-5 of ‘316 recite a humanized anti-APRIL antibody comprised of LCDR1-3 of SEQ ID NOs: 8-10, HCDR1-3 of SEQ ID NOs: 5-7, light chain of SEQ ID NO: 50, and heavy chain of SEQ ID NO: 52. Instant claim 47 is directed to an anti-APRIL antibody of heavy chain variable region of SEQ ID NO: 24 and light chain variable region of SEQ ID NO: 26, which comprises the same 6 CDRs of copending claim 47. Further, heavy chain and light chain of ‘316 are comprised of HCVR and LCVR of instant SEQ ID NO: 24 and SEQ ID NO: 26, respectively, of instant claims 47 and 92.
The ‘316 claims do not teach an antibody formulation and do not specifically exemplify the histidine buffer, arginine viscosity reducer, polysorbate co-solvent, sugar stabilizer (e.g., sorbitol), and pH 6.0-6.6 of instant claim 47. Nor do they disclose the specific concentrations of antibody, buffer, polysorbate 20, or sorbitol, the osmolality, the viscosity, and the optical density of the formulation. However, these ingredients and parameters were used by those skilled in the art to prepare and evaluate formulations for human administration at the time the invention was made, as illustrated by Wang and Whitaker et al, who teach liquid pharmaceutical preparation comprising antibodies and therapeutic uses of such preparations.
Therefore, it would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the dosing of ‘316 in view of Wang to arrive at the dosage and administration sequence of the instant claims. The Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. The dose ranges of Wang encompass the doses of the instant claims. MPEP 2144.05 states that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In addition, MPEP 2144.05 states that “generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). Medical professionals would be motivated to optimize the dosing amount, dosing types, and dosing schedule from the ranges and timeframes provided in Brown to achieve maximum therapeutic efficacy with minimal dosing to reduce cost and side effects. The determination of dosing that would allow the antibody to provide maximum treatment of the patient being treated, while minimizing side effects, in requires only routine experimentation for one of ordinary skill in the art. Therefore, given that the antibody and method of treatment have been previously described, without specific evidence that the indicated dose amounts and dose schedules are critical to the method, the identification of these properties will not render the subject matter patentable.
Amin teaches methods of treatment by administering a therapeutic composition comprised of an antibody. The antibody is formulated in a composition comprising about 150 mg/ml [0256] of antibody, as in instant claims 84 and 90.
With respect to claims 78-84, 88, and 90-91, Amin teaches a method comprising administering to a subject in need a loading dose or an antibody and administering to the subject a plurality of maintenance doses during the treatment phase [0008]; the pharmaceutical composition can be delivered subcutaneously or intravenously [0176]. The loading dose is 600 mg, and the maintenance dose is 300 mg [0014], as in the limitation of instant claim 79 wherein the loading dose is administered at a higher concentration relative to the maintenance dose. The antibody can be administered every 2 or 4 weeks [0024]. Administration may be intravenous or subcutaneous [0176], as in instant claims 81-82.
Given that ‘316, Wang, Whitaker et al, and Amin are drawn to monoclonal antibody treatments and further given that Amin discloses reliable methods for the treatment of disease using a pharmacological composition comprising a monoclonal antibody, it would have been obvious to one of ordinary skill in the art to combine the method of Amin with the combined method of ‘316, Wang, and Whitaker et al to conceive a method of administering a monoclonal antibody at an initial loading dose and subsequent maintenance doses.
The ‘316 claims do teach a method for treating in a subject based on the level of serum IgA. Maeda teaches a diagnostic analysis of patients with IgA nephropathy; one of four identified clinical markers of IgA nephropathy is a serum IgA level greater than 315 mg/dl (i.e. 3.15 mg/ml) (Abstract) as in claim 43. Patients with levels above 315 mg/ml exhibit a poor prognosis. The advantages of using this cutoff are diagnosis IgA nephropathy without renal biopsy (Abstract). It would have been obvious to one of ordinary skill in the art to use a threshold approximating an existing clinical marker in the literature for IgA nephropathy of instant claim 70 because this marker is known to be easily obtained from serum and can identify which patients are likely to benefit from the pharmaceutical composition of instant claim 47, which is taught ‘316 in view of Wang, as discussed above.
Claims 47-54, 60-71, 77-84, 88, and 90-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,377,830 in view of WO 2019/214707 (“Wang”), Whitaker et al, US 2019/0169299 (“Amin”), and Maeda. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to overlapping embodiments: a method for treating IgA nephropathy using the same anti-APRIL antibody.
Claims 1-5 of ‘830 are directed to a method of treating IgA nephropathy, comprising administering a humanized anti-APRIL antibody having LCDR1-3 of SEQ ID NOs: 8-10, HCDR1-3 of SEQ ID NOs: 5-7, light chain of SEQ ID NO: 50, and heavy chain of SEQ ID NO: 52. Instant claim 47 is directed to an anti-APRIL antibody of heavy chain variable region of SEQ ID NO: 24 and light chain variable region of SEQ ID NO: 26, which is comprised of the same 6 CDRs of ‘830 claim 1. Further, heavy and light chain of ‘830 are comprised of HCVR and LCVR of instant SEQ ID NO: 24 and SEQ ID NO: 26, respectively, of instant claims 47 and 92.
The ‘830 claims do not specifically exemplify the histidine buffer, arginine viscosity reducer, polysorbate co-solvent, sugar stabilizer (e.g., sorbitol), and pH 6.0-6.6 of instant claim 47. Nor do they disclose the specific concentrations of antibody, buffer, polysorbate 20, or sorbitol, the osmolality, the viscosity, and the optical density of the formulation. However, these ingredients and parameters were used by those skilled in the art to prepare and evaluate formulations for human administration at the time the invention was made, as taught by Wang, who teaches a liquid pharmaceutical preparation comprising antibodies (e.g., anti-PCSK9) and therapeutic uses of such preparations [0001].
Therefore, it would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the dosing of ‘808 in view of Wang to arrive at the method of the instant claims. The Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. The dose ranges of Wang encompass the doses of the instant claims. MPEP 2144.05 states that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Amin teaches methods of treatment by administering a therapeutic composition comprised of an antibody. The antibody is formulated in a composition comprising about 150 mg/ml [0256] of antibody, as in instant claims 84 and 90.
With respect to claims 78-84, 88, and 90-91, Amin teaches a method comprising administering to a subject in need a loading dose or an antibody and administering to the subject a plurality of maintenance doses during the treatment phase [0008]; the pharmaceutical composition can be delivered subcutaneously or intravenously [0176]. The loading dose is 600 mg, and the maintenance dose is 300 mg [0014], as in the limitation of instant claim 79 wherein the loading dose is administered at a higher concentration relative to the maintenance dose. The antibody can be administered every 2 or 4 weeks [0024]. Administration may be intravenous or subcutaneous [0176], as in instant claims 81-82.
Given that ‘830, Wang, Whitaker et al, and Amin are drawn to monoclonal antibody treatments and further given that Amin discloses reliable methods for the treatment of disease using a pharmacological composition comprising a monoclonal antibody, it would have been obvious to one of ordinary skill in the art to combine the method of Amin with the combined method of ‘830, Wang, and Whitaker et al to conceive a method of administering a monoclonal antibody at an initial loading dose and subsequent maintenance doses.
The ’830 claims do teach a method for treating in a subject based on the level of serum IgA. Maeda teaches a diagnostic analysis of patients with IgA nephropathy; one of four identified clinical markers of IgA nephropathy is a serum IgA level greater than 315 mg/dl (i.e. 3.15 mg/ml) (Abstract) as in claim 43. Patients with levels above 315 mg/ml exhibit a poor prognosis. The advantages of using this cutoff are diagnosis IgA nephropathy without renal biopsy (Abstract). It would have been obvious to one of ordinary skill in the art to use a threshold approximating an existing clinical marker in the literature for IgA nephropathy of instant claim 70 because this marker is known to be easily obtained from serum and can identify which patients are likely to benefit from the pharmaceutical composition of instant claim 47, which is taught ‘830 in view of Wang, as discussed above.
Response to Arguments
Applicant's arguments filed January 20, 2026 have been fully considered but they are not persuasive. Regarding the rejection under 35 U.S.C. 103, applicant sets forth five main lines of argument.
i. Van Eenennaam and Wang do not teach or suggest each and every element of the claimed formulation
Applicant asserts that van Eenennaam does not teach a reason to select the specifically claimed excipients at pH 6.0-6.6 and that the generic assertion to formulate the antibody via methods known to the skilled artisan is not sufficient guidance. As applicant is not convinced by the examiner’s response that Wang cures the deficiencies of van Eenennaam, a new reference, Whitaker et al, has been added to the 103 rejection. As taught by Whitaker et al, high antibody concentration formulations that are required for subcutaneous administration are associated with increased viscosity, which can lead to delivery and stability challenges (abstract). In an effort to identify excipients to reduce viscosity, Whitaker et al developed a screening method of different excipients for high concentration antibody formulations (abstract). In total, 56 FDA-approved additives were screened, including salts, polyols, alcohols, sugars, detergents, proteins, amino acids, and polymers, and the effects on the viscosity and stability of two monoclonal antibodies were examined (pg 3232, column 2). Thus, Whitaker et al demonstrate that the ordinary artisan was aware of the criteria that determine successful development of a high-concentration antibody formulation and that the particular combination of excipients for a given antibody and the needs thereof can be determined by methods already known in the art. The generalized formulation development approach and workflow outlined in Whitaker et al should be applicable to the rapid, empirical approach to the high concentration formulation development of many mAbs (pg 3240, column 2).
Wang and Whitaker et al teach all of the instant excipients of the formulation at various concentrations, indicating that these variables are to be adjusted as needed and arriving at an optimum or workable range is not inventive. Moreover, the instant ranges all lie inside ranges disclosed by Wang and, as such, creates a prima facie case of obviousness. Each component of the instant claims included in the pharmaceutical formulation is merely performing its known function in pharmaceuticals. The prior art recognizes each component and its benefits in an antibody pharmaceutical as well as disclosing ranges for most. “[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 MPEP §2144.05(II). Such is the case here, where there is no evidence that the particular pharmaceutical composition was “invented”, but rather takes known components and uses them for their known use in therapeutics, at best discovering optimum or workable ranges, which is obvious to one of ordinary skill in the art. That which is claimed is merely the optimization of variables within the claims that flow from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 315 F.3d 1325, 1330 (Fed.Cir.2003).
Arguments related to the missing claim elements, including viscosity, osmolality, and optical density” (remarks, pg 11), are not persuasive, because, as recited in MPEP 2112.I, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference”.
Further, applicant points out that Wang teaches a pH range of about 5.0 to 6.0, most preferably about 5.5. Since the claimed formulation has a pH of above 6.0, applicant argues that Wang does not teach the pH. However, as recited in MPEP 2144.05.I, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” In this case, any evidence of unexpected results may render the claims nonobvious. In the absence of unexpected results, such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical.
Applicant provides no evidence that pH claimed is a critical feature drawn to unexpected results regarding antibody aggregation and stability or that the ordinary artisan would not arrive at the claimed formulation by routine optimization/modification. Although Wang does not purport a “universal” antibody formulation (remarks, pg 14), this reference was used to demonstrate that formulations similar to that claimed were known in the art. In the absence of an explicit teaching away, the claimed formulation is obvious, determined by routine optimization. Routine optimization is comprised of methods that are well-understood and conventional activities previously known to the industry. When considering whether the determination of the optimum or workable ranges of a variable (e.g., pH) might be characterized as routine experimentation, the particular parameter must first be recognized as a result-effective variable (see MPEP 2144.05(I)-(II). KSR International Co. v. Teleflex held that “obvious to try” was a valid rational for an obviousness finding when the invention is directed to a result-effective variable. In this case, an artisan prior to the effective filing date of the invention would have a reason to vary the pH of an antibody formulation because pH was recognized as a result-effective variable in the field of antibody formulation with respect to viscosity (see Kang et al). One of ordinary skill in the art would have a reasonable and predictable expectation of arriving at the claimed formulation.
ii. The Office fails to provide a motivation to combine van Eenennaam and Wang
To address this concern, a new reference, Whitaker et al, has been included in the 103 rejection, and provides the motivation to use the formulation of Wang in van Eenennaam. Whitaker et al provides the necessary context for where the antibody formulation field stood at the time the application was filed.
iii. The Office’s evidentiary reference undermines any purported motivation to combine van Eenennaam and Wang
The evidentiary reference Kang et al was applied to address concerns by applicant that the claimed formulation could not have been determined by routine optimization. Like Whitaker et al, its teachings provides context regarding what was well understood at the time the application was filed. Because van Eenennaam in view of Wang teach antibody concentrations and pH values that fall near the claimed range, it would have been obvious to the ordinary artisan to select the recited carriers, excipients, surfactants, and stabilizers of Wang to produce a stable pharmaceutical formulation of the anti-APRIL antibody. One would have been motivated to do so, in view of the art-recognized need, as evidenced by Kang et al and Whitaker et al, to optimize formulations of therapeutic antibodies and have a reasonable expectation of success, based on the knowledge and skill in the art. Further, applicant points out that Wang teaches a pH range of about 5.0 to 6.0, most preferably about 5.5. Since the claimed formulation has a pH of above 6.0, applicant argues that Wang does not teach the pH. However, as recited in MPEP 2144.05.I, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” In this case, any evidence of unexpected results may render the claims nonobvious. In the absence of unexpected results, such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical.
When considering whether the determination of the optimum or workable ranges of a variable (e.g., pH) might be characterized as routine experimentation, the particular parameter must first be recognized as a result-effective variable (see MPEP 2144.05(I)-(II). KSR International Co. v. Teleflex held that “obvious to try” was a valid rational for an obviousness finding when the invention is directed to a result-effective variable. In this case, an artisan prior to the effective filing date of the invention would have a reason to vary the pH of an antibody formulation because pH was recognized as a result-effective variable in the field of antibody formulation with respect to viscosity (see Kang et al). One of ordinary skill in the art would have a reasonable and predictable expectation of arriving at the claimed formulation.
iv. Even if there were a reason to combine van Eenennaam and Wang, a skilled artisan would not have had a reasonable expectation of success
To address this concern, a new reference, Whitaker et al, has been included in the 103 rejection, and provides the motivation to use the formulation of Wang in van Eenennaam. There were methods known in the art at the time the application was filed, as exemplified by Kang et al and Whitaker et al.
Applicant provides evidence for unpredictability of antibody formulation, pointing to Wang 1999 and Wang 2007, which teach that excipients suitable for one antibody may not be suitable for another antibody (remarks, pg 20). Further, applicant asserts that nothing in Wang, as applied in the 103 rejection, suggests that the formulations disclosed therein are broadly applicable to other antibodies (remarks, pg 21). The examiner concedes that the high concentration antibody art was unpredictable 20 years ago; however, as evidenced by Kang et al and Whitaker et al, the ordinary artisan at the time the application was filed would be aware of the progress made in this art and would use the methods to guide development for the claimed formulation.
v. Hindsight is the only reason why a skilled artisan would turn to Wang
In response to applicant's argument that the examiner's conclusion of obviousness over van Eenennaam in view of Wang is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The patentability of a product, in this case a composition, does not depend on its method of determination. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."). MPEP 2113.1. As the claims are not directed to the process of making, the rejections under 103 are maintained for being obvious over the teachings of van Eenennaam in view of Wang and Whitaker et al, which teach the formulation. The difficulty in empirically determining the antibody formulation is not a relevant argument when considering patentability, as the achievement of this goal is possible via methods known in the art (see Whitaker et al). This is because the artisan has good reason to pursue known options within their technical grasp to obtain predictable results. Such would amount to the combining of prior art elements according to known methods to achieve predictable outcomes.
The antibody formulation recited in the claims offer no obvious distinction from those exemplified by the prior art. The Court has stated that generally such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[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). Furthermore, absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. “Good science and useful contributions do not necessarily result in patentability.” PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007).
The 103 rejections of the claims are maintained.
The nonstatutory double patenting rejection of the claims over US 9,969,808 in view of Wang, US 10,961,316 in view of Wang, and US 10,377,830 in view of Wang are maintained. Applicant’s arguments regarding the deficiencies of this combination are not persuasive (see response above regarding maintained 103 rejections).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675 33