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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 April 2026 has been entered.
Status of Claims
Receipt is acknowledged of claim amendments filed on 02 March 2026.
Claim 1 has been amended.
Claims 2-3, 5-6, 8-9, 11-14 and 17-18 are cancelled.
Claims 1, 4, 7, 10 and 15-16 are pending and presented for examination herein.
Rejections Modified and Maintained
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 7, 10 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over OSSLUND (US 2013/0202620 A1) in view of YANG (US 2006/0182740 A1), WINTER (US 2009/0214522 A1, cited in IDS filed 02/23/2024) and CLARKE (“Anti-sclerostin antibodies: Utility in treatment of osoteoporosis”, Marturitas, 78, pages 199-204, 2014).
Osslund is primarily directed towards high concentration antibody formulations comprising an anti-sclerostin immunoglobulin and an acetate salt and/or acetate buffer and methods of use (abstract).
Regarding claims 1, 4 and 10, Osslund discloses that highly concentrated protein formulations pose several problems including instability due to the formation of particulates and increased viscosity. Osslund discloses that highly viscous formulations are difficult to manufacture (paragraph [0002]). Osslund discloses a formulation with an absolute viscosity of about 10 cP or less that comprises an acetate buffer including calcium acetate and at a concentration of including about 10 mM to about 50 mM (paragraph [0010-0011]). Osslund discloses that formulating formulations to treat including osteoporosis (paragraph [0018]). Osslund discloses anti-sclerostin antibody in a formulation present at a concentration of including at least about 120 mg/ml (paragraph [0027]). Osslund discloses that adding relatively low concentrations of calcium acetate to formulations of a selected antibody reduces the viscosity of the formulation (paragraph [0060]). The viscosity of the liquid formulation is including 10 cP or less (paragraph [0061]). Osslund discloses the calcium salt which includes calcium acetate is at a concentration of at least including not greater than 25 mM (e.g., 25 mM or less of calcium and 50 mM or less of acetate) (paragraph [0064]). Osslund discloses in some embodiments, a formulation comprises, in addition to the calcium salt, an acetate buffer at a concentration of at least including 15 mM. Osslund discloses that when the calcium salt is calcium acetate, the total concentration of acetate is about 10 mM to about 50 mM (paragraph [0066]). Osslund discloses excipients including stabilizers are included in the formulation which includes polyols that includes sucrose. Osslund discloses that polyols are used as stabilizing excipients and/or isotonicity agents in both liquid and lyophilized parenteral protein formulations. Osslund discloses that polyols can protect proteins from both physical and chemical degradation pathways (paragraph [0085]). Osslund discloses that the stabilizers is incorporated in a concentration of about 0% to about 40% w/v (paragraph [0087]).
Regarding claim 16, Osslund discloses that the final concentration is in liquid form for administration (e.g., aliquoting into drug product form) (paragraph [0065]). Osslund discloses that protein formulations are generally administered parenterally and must be sterile (paragraph [0072]). Osslund teaches the formulations are packaged in a unit dosage form (paragraph [0112]).
Regarding claim 10, Osslund discloses a formulation with an absolute viscosity of about 10 cP or less that comprises an acetate buffer including sodium acetate and at a concentration of including 10 mM to about 50 mM (e.g., 10 to about 50 mM acetate) (paragraph [0010]). Osslund discloses the calcium salt which includes calcium acetate is at a concentration of at least including not greater than 25 mM (e.g., 25 mM or less of calcium and 50 mM acetate) (paragraph [0064]). Therefore, the amount of calcium ranges from 25 mM or less and acetate ranges from about 35 mM or less to about 85 or mM or less (25+10=35 and 25+50=85).
Osslund does not specifically teach diafiltration buffer exchanging the composition comprising the anti-sclerostin antibody and at a temperature greater than 30°C. Osslund does not specifically teach that the anti-sclerostin antibody is romosozumab. The deficiencies are made up for by the teachings off Yang, Winter and Clarke.
Yang is primarily directed towards a method for producing a concentrated antibody preparation (abstract).
Regarding claim 1, Yang teaches that highly concentrated solution of MAbs (monoclonal antibodies) can be produced by ultrafiltration, a technique in which a solution of MAbs is concentrated by filtering the antibody solution under pressure through a membrane filter with pores that retain the MAbs while allowing the solvent and small solute molecules to pass through (paragraph [0008]). Yang teaches antibody preparations consisting essentially of an aqueous solution of antibodies and acetate buffer at a concentration in the range of from about 3 mM to about 48 mM, with a pH in the range of from about 4.0 to about 7.5 (paragraph [0045]). Yang teaches including using buffers containing acetate conjugated with counterions components other than Na+ and Cl- (paragraph [0045]). Yang teaches that it was discovered that the stability and viscosity of an antibody preparation subjected to concentration by membrane ultrafiltration is sensitive to the type of buffer present in the preparation, and that certain buffers, in particular, including acetate, unexpectedly lower the viscosity of an antibody preparation, reduce antibody aggregation, and increase the rate of concentration of the antibody preparation by membrane filtration, relative to what is obtained using other buffers (paragraph [0057]). Yang teaches that diafiltration is the fractionation process in which smaller molecules are washed through the membrane, leaving the larger molecules of interest in the retentate (paragraph [0059]).
Regarding claim 15, Yang teaches sterilization of antibody composition by including microfiltration (paragraph [0068]).
Winter is primarily directed towards a process for concentrating proteins including an ultrafiltering, a diafiltering, and a second ultrafiltering sequence, at elevated temperatures, such as above about 30º C (abstract).
Regarding claims 1 and 7, Winter teaches that methods for isolating, purifying, and concentrating biological materials are known and include ultrafiltration. Winter teaches that that processes for making concentrated monoclonal antibody preparations for administration to humans are known including a process that uses ultrafiltration (paragraph [0002]). Winter teaches processes for concentrating proteins including antibody that comprises a step of ultrafiltering an antibody preparation; wherein the ultrafiltering is accomplished at elevated temperatures of including from about 30º C to about 50º C (paragraph [0006]). Winter teaches that if temperatures are too high the preparations may show signs of deterioration, such as denaturation, agglomeration, and like phenomena (paragraph [0045]). Winter teaches that processes accomplished at temperatures below from about 30º C to about 35º C, the flow rates are typically undesirably low and process times are undesirably long, making the process at lower temperatures less attractive for efficient commercial production (paragraph [0045]). Winter teaches concentrated monoclonal antibody preparation produced with a concentration (e.g. of antibody) of greater than or equal to about 100 g/L (mg/mL) (paragraph [0065]). Winter teaches that the antibody preparations include a stabilizer including sugars (paragraph [0071]).
Clarke is primarily directed towards is primarily directed towards romosozumab, the first humanized anti-sclerostin antibody, as a promising agent for the treatment of osteoporosis due to the properties of romosozumab including increases bone formation and BMD (bone mineral density) (abstract).
Regarding claim 1, Clarke teaches that romosozumab is the first humanized anti-sclerostin antibody that has been shown to increase bone formation. Clarke teaches that romosozumab have osteoanabolic properties with the potential to improve clinical outcomes in patients with osteoporosis. Clarke teaches that romosozumab increases bone formation and BMD (page 200, first column, second paragraph).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce an antibody formulation by performing a method that comprises ultrafiltering (e.g. ultrafiltration/diafiltration) a composition comprising an antibody that is romosozumab, calcium acetate (e.g. diafiltration buffer), and acetate buffer including sodium acetate, and a polyol including sucrose as a stabilizer; wherein the composition comprises the antibody at a concentration of including at least about 120 mg/ml; wherein the calcium acetate is at a concentration of including not greater than 25 mM; wherein the amount of the acetate buffer including sodium acetate is from including about 10 mM to about 50 mM (e.g., 10 to about 50 mM acetate); wherein the viscosity of the antibody formulation is about 10 cP or less; wherein the ultrafiltering (e.g. ultrafiltration/diafiltration) is at a temperature above about 30º C; and wherein the amount of the polyol is about 0% to about 40% w/v. The person of ordinary skill in the art would have been motivated to make those modifications because: (1) Osslund discloses producing an antibody composition with a viscosity less than 10 cP which is which eases manufacture of antibody formulation and Yang teaches that an antibody composition buffered with an acetate provides an antibody composition with lower viscosity which can be used in ultrafiltration, which is used to produce highly concentrated antibody formulations, therefore, one of ordinary skill in the art would have provided the composition of Osslund which contains an anti-sclerostin antibody, calcium acetate and has low viscosity (e.g. similar to the composition taught by Yang for ultrafiltering) and used the composition of Osslund for ultrafiltering to obtain a highly concentrated anti-sclerostin antibody formulation; (2) Winter teaches that elevated temperature of including from about 30º C to about 50º C during including ultrafiltration provides higher flow rates and faster process times, therefore, one of ordinary skill in the art would perform the ultrafiltering step at elevated temperatures of including from about 30º C to about 50º C; and (3) Clarke teaches that romosozumab is a known anti-sclerostin antibody that has properties including increases bone formation, bone mineral density and is promising for treating osteoporosis, which one would select as the protein to perform a method that produces a high concentration. The person of ordinary skill in the art would have reasonably expected success because Osslund discloses that highly concentrated protein formulations pose several problems including instability due to the formation of particulates and increased viscosity. Osslund discloses that highly viscous formulations are difficult to manufacture (paragraph [0002]). Osslund discloses a formulation with an absolute viscosity of about 10 cP or less that comprises an acetate buffer including calcium acetate and at a concentration of including about 10 mM to about 50 mM (paragraph [0010-0011]). Osslund discloses that formulating formulations to treat including osteoporosis (paragraph [0018]). Osslund discloses that adding relatively low concentrations of calcium acetate to formulations of a selected antibody reduces the viscosity of the formulation (paragraph [0060]). Yang teaches that highly concentrated solution of MAbs (monoclonal antibodies) can be produced by ultrafiltration (paragraph [0008]). Yang teaches antibody preparations consisting essentially of an aqueous solution of antibodies and acetate buffer at a concentration in the range of from about 3 mM to about 48 mM, with a pH in the range of from about 4.0 to about 7.5 (paragraph [0045]). Yang teaches that it was discovered that the stability and viscosity of an antibody preparation subjected to concentration by membrane ultrafiltration is sensitive to the type of buffer present in the preparation, and that certain buffers, in particular, including acetate, unexpectedly lower the viscosity of an antibody preparation, reduce antibody aggregation, and increase the rate of concentration of the antibody preparation by membrane filtration, relative to what is obtained using other buffers (paragraph [0057]). Winter teaches processes for concentrating proteins including antibody that comprises a step of ultrafiltering an antibody preparation; wherein the ultrafiltering is accomplished at elevated temperatures of including from about 30º C to about 50º C (paragraph [0006]). Winter teaches that if temperatures are too high the preparations may show signs of deterioration, such as denaturation, agglomeration, and like phenomena (paragraph [0045]). Winter teaches that processes accomplished at temperatures below from about 30º C to about 35º C, the flow rates are typically undesirably low and process times are undesirably long, making the process at lower temperatures less attractive for efficient commercial production (paragraph [0045]). Clarke teaches that romosozumab is the first humanized anti-sclerostin antibody that has been shown to increase bone formation. Clarke teaches that romosozumab have osteoanabolic properties with the potential to improve clinical outcomes in patients with osteoporosis. Clarke teaches that romosozumab increases bone formation and BMD (page 200, first column, second paragraph).
Regarding the temperature of the ultrafiltration (e.g. buffer exchanging) in claims 1 and 5-7, Winter teaches processes for concentrating proteins including antibody that comprises a step of ultrafiltering an antibody preparation; wherein the ultrafiltering is accomplished at elevated temperatures of including from about 30º C to about 50º C (paragraph [0006]). Winter teaches that if temperatures are too high the preparations may show signs of deterioration, such as denaturation, agglomeration, and like phenomena (paragraph [0045]). Winter teaches that processes accomplished at temperatures below from about 30º C to about 35º C, the flow rates are typically undesirably low and process times are undesirably long, making the process at lower temperatures less attractive for efficient commercial production (paragraph [0045]). Therefore, the temperature of ultrafiltration is an art-recognized result-effective variable, e.g., effects flow rates and process times, which a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal elevated temperature to perform the ultrafiltration (e.g. buffer exchanging) in order to obtain a process with a higher flow rate and shorter process time. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Regarding the amount of the calcium acetate (e.g. diafiltration buffer) in claim 9-10, Osslund discloses that adding relatively low concentrations of calcium acetate to formulations of a selected antibody reduces the viscosity of the formulation (paragraph [0060]). The viscosity of the liquid formulation is including 10 cP or less (paragraph [0061]). Osslund discloses the calcium salt which includes calcium acetate is at a concentration of at least including not greater than 25 mM (paragraph [0064]). Yang teaches antibody preparations consisting essentially of an aqueous solution of antibodies and acetate buffer at a concentration in the range of from about 3 mM to about 48 mM, with a pH in the range of from about 4.0 to about 7.5 (paragraph [0045]). Yang teaches that certain buffers, in particular, including acetate, unexpectedly lower the viscosity of an antibody preparation, reduce antibody aggregation, and increase the rate of concentration of the antibody preparation by membrane filtration, relative to what is obtained using other buffers (paragraph [0057]). Therefore, the amount calcium acetate in the antibody composition used for ultrafiltration is an art-recognized result-effective variable, e.g., lowers antibody composition viscosity, which a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of calcium acetate to include in the antibody composition used for ultrafiltration in order to lower the viscosity of antibody composition, reduce antibody aggregation, and increase the rate of concentration of the antibody by ultrafiltration. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues that composition recited in the amended claim 1 has unexpected results of calcium concentration decreasing below diafiltration (DF) buffer concentration upon overconcentration rather than increases above the DF buffer concentration upon overconcentration. Applicant points to paragraphs [0078-0080] and Tables 1-2 of the instant specification for evidence. Applicant argues that the instant specification explains that "[i]f the calcium was concentrated to the same degree, the 20 mM calcium DF buffer concentration would increase to at least 65 mM. Surprisingly, the experimental observation is the opposite, wherein the calcium concentration decreases below the DF buffer concentration upon overconcentration" (paragraph [0078] of the instant specification). Applicant points to Table 2 and paragraph [0080] of the instant specification to show that as the antibody concentration increases from 66.15 mg/mL to 173.99 mg/mL, the calcium concentration decreases from 14.1 mM to 10.2 mM.
Applicant's arguments filed 02 March 2026 have been fully considered but they are not persuasive. In response, while the instant specification contains the statement "the 20 mM calcium DF buffer concentration would increase to at least 65 mM. Surprisingly, the experimental observation is the opposite, wherein the calcium concentration decreases below the DF buffer concentration upon overconcentration", there is no clear evidence that one of ordinary skill in the art would expect a concentration of 20 mM calcium acetate would lead to an increase in calcium concentration of at least 65 mM after overconcentration using ultrafiltration. Yang teaches that the ultrafiltration removes water and buffer (paragraph [0021]). Yang also teaches that the resulting concentrated antibody preparation consists the buffer at a concentration in the range of from about 2 mM to about 48 mM (paragraph [0043]). Therefore, from the teachings of Yang, the concentration of calcium would have been expected to at least partially decrease (e.g., some of the calcium is removed and some remain to give a concentration range of from about 2 mM to about 48 mM).
Applicant argues that the final composition that comprises about 50 mM acetate and about 12 mM calcium is not merely a latent property because it is a claimed limitation that defines the method and its outcome. Applicant argues that the Office has not established that (1) the cited art defines or suggests a method comprising a buffer exchanging step that results in this specific final composition or (2) that a person of ordinary skill would not have expected this outcome based on the combined teachings of Osslund, Yang, Winter and Clarke.
Applicant's arguments filed 02 March 2026 have been fully considered but they are not persuasive. In response, Osslund discloses that highly concentrated protein formulations pose several problems including instability due to the formation of particulates and increased viscosity. Osslund discloses that highly viscous formulations are difficult to manufacture (paragraph [0002]). Osslund discloses a formulation with an absolute viscosity of about 10 cP or less that comprises an acetate buffer including calcium acetate and at a concentration of including about 10 mM to about 50 mM (paragraph [0010-0011]). Osslund discloses that formulating formulations to treat including osteoporosis (paragraph [0018]). Osslund discloses that adding relatively low concentrations of calcium acetate to formulations of a selected antibody reduces the viscosity of the formulation (paragraph [0060]). Yang teaches that highly concentrated solution of MAbs (monoclonal antibodies) can be produced by ultrafiltration (paragraph [0008]). Yang teaches antibody preparations consisting essentially of an aqueous solution of antibodies and acetate buffer at a concentration in the range of from about 3 mM to about 48 mM, with a pH in the range of from about 4.0 to about 7.5 (paragraph [0045]). Yang teaches that it was discovered that the stability and viscosity of an antibody preparation subjected to concentration by membrane ultrafiltration is sensitive to the type of buffer present in the preparation, and that certain buffers, in particular, including acetate, unexpectedly lower the viscosity of an antibody preparation, reduce antibody aggregation, and increase the rate of concentration of the antibody preparation by membrane filtration, relative to what is obtained using other buffers (paragraph [0057]). Winter teaches processes for concentrating proteins including antibody that comprises a step of ultrafiltering an antibody preparation; wherein the ultrafiltering is accomplished at elevated temperatures of including from about 30º C to about 50º C (paragraph [0006]). Winter teaches that if temperatures are too high the preparations may show signs of deterioration, such as denaturation, agglomeration, and like phenomena (paragraph [0045]). Winter teaches that processes accomplished at temperatures below from about 30º C to about 35º C, the flow rates are typically undesirably low and process times are undesirably long, making the process at lower temperatures less attractive for efficient commercial production (paragraph [0045]). Clarke teaches that romosozumab is the first humanized anti-sclerostin antibody that has been shown to increase bone formation. Clarke teaches that romosozumab have osteoanabolic properties with the potential to improve clinical outcomes in patients with osteoporosis. Clarke teaches that romosozumab increases bone formation and BMD (page 200, first column, second paragraph). Therefore, from the disclosure of Osslund and the teachings of Yang, Winter and Clarke, it would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce an antibody formulation by performing a method that comprises ultrafiltering (e.g. ultrafiltration/diafiltration) a composition comprising an antibody that is romosozumab, calcium acetate (e.g. diafiltration buffer), and acetate buffer including sodium acetate, and a polyol including sucrose as a stabilizer; wherein the composition comprises the antibody at a concentration of including at least about 120 mg/ml; wherein the calcium acetate is at a concentration of including not greater than 25 Mm; wherein the amount of the acetate buffer including sodium acetate is from including about 10 mM to about 50 mM (e.g., 10 to about 50 mM acetate); wherein the viscosity of the antibody formulation is about 10 cP or less; wherein the ultrafiltering (e.g. ultrafiltration/diafiltration) is at a temperature above about 30º C; and wherein the amount of the polyol is about 0% to about 40% w/v. The person of ordinary skill in the art would have been motivated to make those modifications because: (1) Osslund discloses producing an antibody composition with a viscosity less than 10 cP which is which eases manufacture of antibody formulation and Yang teaches that an antibody composition buffered with an acetate provides an antibody composition with lower viscosity which can be used in ultrafiltration, which is used to produce highly concentrated antibody formulations, therefore, one of ordinary skill in the art would have provided the composition of Osslund which contains an anti-sclerostin antibody, calcium acetate and has low viscosity (e.g. similar to the composition taught by Yang for ultrafiltering) and used the composition of Osslund for ultrafiltering to obtain a highly concentrated anti-sclerostin antibody formulation; (2) Winter teaches that elevated temperature of including from about 30º C to about 50º C during including ultrafiltration provides higher flow rates and faster process times, therefore, one of ordinary skill in the art would perform the ultrafiltering step at elevated temperatures of including from about 30º C to about 50º C; and (3) Clarke teaches that romosozumab is a known anti-sclerostin antibody that has properties including increases bone formation, bone mineral density and is promising for treating osteoporosis, which one would select as the protein to perform a method that produces a high concentration. The method which is prima facie obvious in light of the disclosure of Osslund and the teachings of Yang, Winter and Clarke, which comprises ultrafiltration of a composition that has substantially the same amount of antibody, substantially the same amount of calcium acetate, substantially the same amount of sucrose, and at substantially the same temperature, would necessarily experience the same effect, e.g., wherein the pharmaceutical formulation after the exchanging step comprises about 50 mM acetate and about 12 mM calcium.
Applicant is reminded that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991). In the instant case, in light of the disclosure of Osslund and the teachings of Yang, Winter and Clarke, one of ordinary skill in the art would expected that combining ultrafiltration of a composition comprising a protein and calcium acetate with elevated temperature of from about 30º C to about 50º C would result in production of a high concentration of the protein at faster process times. Latent properties (e.g., decrease in the concentration of calcium after overconcentration of from 20 mM to about 12 mM) in the method that is prima facie obvious in light of the disclosure of Osslund and the teachings of Yang, Winter and Clarke does not render nonobvious an otherwise known invention.
Thus, for the reasons of record and for the reasons presented above claims 1, 4, 7, 10 and 115-16 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are allowed.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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