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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/19/2025 has been entered.
Response to Amendment
Applicant’s remarks and amendments to the claims received 02/02/26 have been acknowledged. Claim 1 has been amended. Claims 40-42 are newly added.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-9, 11-14, 21-23, and 37-42 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Shenoy (US20180333493A1, of record) as evidenced by the U.S. Federal Drug Administration (FDA) label for omalizumab (XOLAIR® (omalizumab) injection for subcutaneous use [package insert]. Accessdata.fda.gov. 2021, of record).
Shenoy discloses low-viscosity, high concentration therapeutic protein agent liquid formulations that allow for stable long-term storage, comprising 150 to 300 mg/mL of a therapeutic protein agent that is a monoclonal antibody or fragment thereof, 15 to 25 mM of a phosphate or L-histidine buffer, 50 to 200 mM of one or more viscosity reducing agents such as arginine or lysine, and one or more excipients including surfactants such as polysorbate 20, polysorbate 80, or poloxamer 188 added in the range of 0.001% to 1.0% (w/v) (or. 0.001 to 5.0%), wherein the monoclonal antibody can be an anti-IgE antibody such as Omalizumab (see entire document, in particular, Abstract, Summary of Invention, and Claims, including Para. 0007-0011, 0036-0039; Para. 0049; Para. 0111; Para. 0152; Protein Agents section, in particular, Para. 0195; “Liquid Media” section, in particular, Para. 0199 and Para. 0201; “Viscosity-Reducing Agents” section, in particular, Para. 0210, Para. 0218 and Para. 0234; “Other Components” section, in particular, Para. 0246-0247, 0251-0254; “Characteristics: Viscosity” section, in particular, Para. 0261-0262; “Aqueous Liquid Formulations” section, Para. 0286; Claims 3-13 and 16-51). The buffer can also be present from about 10 -300 mM (Claim 17), which would encompass 5-20 mg/mL histidine, equivalent to about 40 to 160 mM (see Examples 3 and 6 of instant specification). Omalizumab (Xolair ®) is produced in recombinant CHO cell suspension culture as evidenced by the U.S. Federal Drug Administration (FDA) label for omalizumab (Xolair®) (see page 21 under “Description). Salts of amino acids including lysine or arginine are also contemplated (Para. 0258). The use of a viscosity-reducing agent reduces the viscosity of the protein agent formulation to a viscosity in the range of about 5 cP to 15 cP when measured at 25℃ (Para. 0054 and Para. 0168). The pH can be adjusted to maximize stability and solubility of a particular protein agent and, in some embodiments, can be in the range of about 6.2 to 7.0 (Para. 0055). The therapeutic protein agent formulations can be used in the treatment of asthma, chronic idiopathic urticaria, acute bronchospasm or status asthmaticus (Para. 0355). Drug delivery devices, such as an injection pen, autoinjector or syringe (including pre-filled syringes), to facilitate the administration of the therapeutic protein agent formulations are also disclosed (see Kits and Articles of Manufacture, Enteral Routes of Administration, Parenteral Routes of Administration, Self-Mixing Syringes, Pre-Filled Syringes, and Needleless Syringes sections as well as Para. 0059 and 0316). The pharmaceutical composition preferably has an osmolality that will range from about 180 to about 420 mOsm/kg or which falls within the range recited in claim 38 (e.g. about 360 mOsm/L, about 380 mOsm/L, or about 400 mOsm/L) (Para. 0255 and Para. 0269-0273). A stable formulation can be one in which more than 95% of the bioactive protein molecules retain bioactivity in a formulation after 1 month of storage at 40℃ (Para. 0162). Per the instant claims, a pharmaceutical formulation of the minimally requires omalizumab (which is produced from CHO cell culture medium), a phosphate buffer, an aggregation inhibitor (e.g. arginine, lysine, or salt thereof) and a surfactant to achieve the following: (1) at least 98% of the omalizumab present as omalizumab monomer following storage at 37℃ for 1 month as measured by SEC per claim 1; (2) the percentages of high molecular weight (HMW) and low molecular weight (LMW) species as well as acidic and basic variants recited in claim 40 when stored at 37℃ for 1 month; (3) thermal stability with an onset temperature of 60.1 to 62.2℃ per claim 41; and (4) the percentages of HMW/LMW species as well as acidic/basic variants recited in claim 42 when stored at 2-8℃ for 3 months. Thus, the compositions of Shenoy will necessarily yield the same intended results recited in claims 1 and 40-42.
Thus, Shenoy meets the limitations of instant claims 1, 3-9, 11-14, 21-23, and 37-42.
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.
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shenoy, as applied to claims 1, 3-9, 11-14, 21-23, and 37-42 above, and further in view of Patel et al (WO2017180594A1, of record), hereinafter Patel.
The teachings of Shenoy have been discussed above and differ from the instantly claimed invention in that it is not specifically taught that the lysine-salt or arginine-salt present in the formulations is lysine-HCl or arginine-HCl.
However, Patel teaches that high protein concentration pharmaceutical compositions comprising amino acids such as lysine, arginine, or salts-thereof as stabilizing compounds can improve and/or maintain the long-term stability of the protein molecule in order to facilitate treatment or prevention of a disease or condition. (see entire document, in particular, Abstract, Summary of Invention, Claims), wherein the compositions are liquid formulations (see, e.g. Para. 0055-0057). Salts of lysine and arginine include, for example, those derived from an appropriate acid, including hydrochloric (HCl) acid (Para. 0048).
It would have been obvious to one of ordinary skill in the art to modify the formulations of Shenoy such that they comprise the salts of lysine or arginine, particularly, lysine-HCl or arginine-HCl. One of ordinary skill in the art would have been motivated to do so since lysine, arginine, or salts thereof can be used in high protein concentration liquid compositions to improve and/or maintain long-term stability of the protein biomolecule in order to facilitate treatment or prevention of a disease or condition by the composition. Therefore, one of ordinary skill in the art would expect that the formulations of Shenoy modified to comprise the salts of lysine or arginine, particularly, lysine-HCl or arginine-HCl, can be used to effectively provide long-term stability to a high protein concentration composition.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-7, 11-14, 21-23, and 37-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending Application No. 18926965 in view of Shenoy (US20180333493A1, of record).
This is a provisional nonstatutory double patenting rejection.
The co-pending claims recite a pharmaceutical stable liquid formulation comprising 1) 100 to 200 mg/mL of Omalizuamb, 5 to 20 mg/mL of a phosphate buffer, 100 to 200 mM arginine or suitable salt thereof, such as arginine-HCl, and 0.02 to 0.04% of polysorbate or poloxamer 188 at pH 6.0 to 7.0, wherein the omalizumab is produced from Chinese Hamster Ovary cell culture medium(co-pending claims 1 and 2-12). Further disclosed is a drug delivery device comprising the pharmaceutical liquid formulation and a method of treating asthma, urticaria, allergy, or chronic idiopathic urticaria in a patient comprising administering the pharmaceutical liquid formulation (co-pending claims 13 and 14). Lastly, the pharmaceutical liquid formulation has a kinematic viscosity of about 10, 11, 12, 13, 14, or 15 cp (co-pending claim 15). The pharmaceutically stable liquid formulation comprises at least 90% monomer [of omalizumab] upon storage at 37℃ for 1 month (co-pending claim 16). Per the instant claims, a pharmaceutical formulation minimally requires omalizumab (which is produced from CHO cell culture medium), a buffer, an aggregation inhibitor (e.g. arginine or salt thereof) and a surfactant to achieve the following: (1) at least 98% of the omalizumab present as omalizumab monomer following storage at 37℃ for 1 month as measured by SEC per claim 1; (2) the percentages of high molecular weight (HMW) and low molecular weight (LMW) species as well as acidic and basic variants recited in claim 40 when stored at 37℃ for 1 month; (3) thermal stability with an onset temperature of 60.1 to 62.2℃ per claim 41; and (4) the percentages of HMW/LMW species as well as acidic/basic variants recited in claim 42 when stored at 2-8℃ for 3 months. Thus, the compositions of co-pending claims will necessarily yield the same intended results recited in instant claims 1 and 40-42.
The co-pending claims do not disclose that the drug delivery device is a pre-filled syringe nor that the pharmaceutically stable liquid formulation has osmolality of 350 to 410 mOsm.
However, Shenoy discloses low-viscosity, high concentration monoclonal antibody-containing liquid formulations that allow for stable long-term storage, comprising 150 to 300 mg/mL of monoclonal antibody or fragment thereof, 15 to 25 mM of a phosphate o buffer, 50 to 200 mM of one or more viscosity reducing agents such as arginine, and one or more excipients including surfactants such as polysorbate 20, polysorbate 80, or poloxamer 188 added in the range of 0.001% to 1.0% (w/v) (or. 0.001 to 5.0%), wherein the monoclonal antibody can be an anti-IgE antibody such as Omalizumab (see entire document, in particular, Abstract, Summary of Invention, and Claims, including Para. 0007-0011, 0036-0039; Para. 0049; Para. 0111; Para. 0152; Protein Agents section, in particular, Para. 0195; “Liquid Media” section, in particular, Para. 0199 and Para. 0201; “Viscosity-Reducing Agents” section, in particular, Para. 0210, Para. 0218 and Para. 0234; “Other Components” section, in particular, Para. 0246-0247, 0251-0254; “Characteristics: Viscosity” section, in particular, Para. 0261-0262; “Aqueous Liquid Formulations” section, Para. 0286; Claims 3-13 and 16-51). Drug delivery devices, such as a syringe (including pre-filled syringes), to facilitate the administration of the therapeutic monoclonal formulations are also disclosed (see Kits and Articles of Manufacture, Enteral Routes of Administration, Parenteral Routes of Administration, Self-Mixing Syringes, Pre-Filled Syringes, and Needleless Syringes sections as well as Para. 0059 and 0316). The pharmaceutical composition preferably has an osmolality that will range from about 180 to about 420 mOsm/kg or which falls within the range recited in claim 38 (e.g. about 360 mOsm/L, about 380 mOsm/L, or about 400 mOsm/L) (Para. 0255 and Para. 0269-0273).
It would have been obvious to one of ordinary skill in the art to modify the co-pending claims such that the drug-filled delivery device is a pre-filled syringe and the pharmaceutically acceptable formulation has an osmolality that falls within the range recited in the instant claims. One of ordinary skill in the art would have been motivated to do so since pre-filled syringes are suitable drug delivery devices for the formulations of the co-pending claims as taught by Shenoy. Further, an osmolality that falls within the range recited in the instant claims as taught by Shenoy will yield a stable, liquid formulation for the monoclonal antibody omalizumab. Therefore, one of ordinary skill in the art would expect pre-filled syringes to be suitable drug delivery devices for the formulations of the instant claims and further an osmolality that falls within the range of 350-410 mOsm (e.g. about 360 mOsm/L, about 380 mOsm/L, or about 400 mOsm/L) to yield a stable formulation for the monoclonal antibody omalizumab.
Claims 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending Application No. 18926965, as applied to claims 1, 3-7, 11-14, 21-23, and 37-42 above, and further in view of Patel et al (WO2017180594A1, of record), hereinafter Patel.
This is a provisional non-statutory double patenting rejection.
The teachings of the co-pending claims in view of Shenoy have been discussed above and differ from the instantly claimed invention in that it is not specifically taught that the arginine-salt present in the formulations is arginine-HCl.
However, Patel teaches that high protein concentration pharmaceutical compositions comprising amino acids such as arginine or salts-thereof as stabilizing compounds can improve and/or maintain the long-term stability of the protein molecule in order to facilitate treatment or prevention of a disease or condition. (see entire document, in particular, Abstract, Summary of Invention, Claims), wherein the compositions are liquid formulations (see, e.g. Para. 0055-0057). Salts of arginine include, for example, those derived from an appropriate acid, including hydrochloric (HCl) acid (Para. 0048).
It would have been obvious to one of ordinary skill in the art to modify the formulations of the co-pending claims in view of Shenoy such that they comprise the salts of arginine, particularly, arginine-HCl. One of ordinary skill in the art would have been motivated to do so since arginine or salts thereof can be used in high protein concentration compositions to improve and/or maintain long-term stability of the protein biomolecule in order to facilitate treatment or prevention of a disease or condition by the composition. Therefore, one of ordinary skill in the art would expect that the formulations of the co-pending claims modified to comprise the salts of arginine, particularly, or arginine-HCl, can be used to effectively provide long-term stability to a high protein concentration composition.
Response to Arguments
Applicant's arguments filed 02/02/26 have been fully considered but they are not persuasive.
With respect to the rejection made under 35 U.S.C. 102, Applicant argues that Shenoy fails to disclose each and every element of the claimed pre- filled syringe (PFS), including: CHO-derived omalizumab; a phosphate buffer; arginine or lysine, or a salt thereof; a surfactant; and a pharmaceutically stable liquid formulation where at least 98% of the omalizumab is present as omalizumab monomer following storage of the pharmaceutically stable liquid formulation at 37 °C for 1 month, as measured by Size Exclusion Chromatography.
In particular, Applicant contends that Shenoy is silent on omalizumab produced from Chinese Hamster Ovary cell culture medium, including disclosure of production source, cell line, and manufacturing process of the omalizumab, stating that differences in cell line origin are known to affect glycosylation, aggregation tendency, and stability, particularly under thermal stress.
Moreover, Applicant argues that Shenoy only discloses pharmaceutical formulations stored at 4C and 25C but is silent on the pharmaceutical formulations of the instant claims. It is further alleged that the prior art is focused on lyophilized formulations as it emphasizes the importance of viscosity reduction (not long-term thermal stability) and the use of excipients such as nicotinic acid, tryptophan, caffeine, and caffeine citrate to achieve lyophilized formulations.
Lastly, Applicant particularly notes that Shenoy demonstrates that arginine and lysine increase viscosity in several tested conditions whereas the amino acid tryptophan, caffeine citrate, caffeine, or uridine help lower the viscosity of a protein agent solution. The preferred viscosity-reducing agents are allegedly nicotinic acid and tryptophan. The working examples of Shenoy demonstrates that different factors influence the viscosity of Human Gamma Globulin (HGG) solutions: higher HGG concentration raises viscosity, while several additives such as certain amino acids, nucleosides, salts, vitamins, and organic solvents can reduce it. Among these, as Applicant points out, tryptophan, caffeine/caffeine citrate, sodium chloride, nicotinic acid, and polysorbate-80 are notable viscosity-reducing agents. In view of the above, Applicant contends that the instant claims as amended are novel over the cited prior art.
In response to Applicant’s argument, the Examiner reiterates that omalizumab (Xolair ®) disclosed in Shenoy is produced in recombinant CHO cell suspension culture as evidenced by the U.S. Federal Drug Administration (FDA) label for omalizumab (Xolair®) and discussed in the rejection above. Thus, the cited prior art teaches a formulation comprising omalizumab produced in CHO cells per the instant claims.
Further, given that the pharmaceutical formulation of the instant claims minimally requires omalizumab (which is produced from CHO cell culture medium), a phosphate buffer, an aggregation inhibitor (e.g. arginine, lysine, or salt thereof) and a surfactant to achieve at least 98% of the omalizumab to be present as omalizumab monomer following storage at 37℃ for 1 month as measured by SEC, the compositions of Shenoy will necessarily yield the same intended result. It is also noted that the teachings of Shenoy are not limited to lyophilized formulations but encompass liquid formulations that allow for stable, long-term storage as well contrary to Applicant’s assertions (see, e.g. Para. 0036-0039, Para. 0286, and Claims 3 and 28). Similarly, viscosity-reducing agents in Shenoy are not limited to nicotinic acid, tryptophan, caffeine, and caffeine citrate as arginine and lysine are also exemplified throughout its disclosure.
Lastly, it is acknowledged that Shenoy presents a comparative study on various amino acids or its derivatives and their effect on the viscosity of HGG in phosphate, buffer, or histidine buffer in Example 4. Although it is stated that tryptophan helps to lower the viscosity of the protein agent solution, it cannot be concluded that arginine and lysine are poor viscosity-reducing agents based on the data presented as it does not appear that the viscosity of the HGG-containing formulations before and after addition of a given amino acid excipient was uniformly determined. Each formulation differed in the concentration of the protein agent HGG as well as the concentration of the amino acid excipient. These confounding variables significantly complicate the determination of an individual amino acid’s direct impact on the viscosity of the HGG-containing formulation and it’s viscosity relative to that of other amino acids. Thus, a useful comparison cannot be made. Based on the data presented, it can only be safely concluded that an HGG-containing formulation comprising 200 mg/mL HGG, and 25 mM phosphate buffer, pH 6.0 at 25C had a viscosity of 29 cP which was reduced to 14 cP after addition of 29 mM tryptophan as shown in Table 3. However, given the confounding variables, it cannot be concluded that arginine and lysine increase viscosity as Applicant contends. Nevertheless, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) (see MPEP 2123). In this case, the amino acids arginine and lysine are exemplified as viscosity-reducing agents throughout the disclosure of Shenoy and thus can be used to make pharmaceutically stable liquid formulations. As such, Shenoy does teach each and every element of claim 1.
Therefore, the rejection under 35 U.S.C. 102 rejection is maintained.
With respect to the rejection made under 35 U.S.C. 103, Applicant argues that Patel fails to cure the deficiencies of Shenoy, further pointing out that Patel is directed toward lyophilized or cryopreserved powder formulations and does not teach or suggest methods of stabilizing liquid formulations. In particular, Applicant sates that Patel teaches improved pharmaceutical compositions containing high concentrations of protein biomolecules, wherein amino acid compounds rather than sugars are used to reduce time to reconstitute lyophilized formulations, while maintaining or enhancing long-term stability.
In response to Applicant’s argument, the Examiner notes that Patel is not limited to lyophilized or cryopreserved powder formulations but also encompass liquid formulations as well (see, e.g. Para. 0055-0056). Again, disclosed examples or preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971) (MPEP 2123). Thus, the rejection under 35 USC 103 is maintained.
With respect to the double patenting rejection, Applicant requests that the double patenting rejection be held in abeyance until patentable subject matter has been identified. Since no terminal disclaimers have been filed and no amendments have been made to the instant or co-pending claims such that they represent patentably distinct inventions, the double patenting rejections previously set forth are maintained.
Conclusion
No claims are allowable.
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/LIA E TAYLOR/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641