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 .
Response to Amendment
Applicant’s remarks and amendments to the claims received 09/25/2205 have been acknowledged. Claim 1 has been amended.
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 and 3-16 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).
Shenoy discloses low-viscosity, high concentration therapeutic protein agent 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 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 (Xolair®) (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. 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). 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). 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). 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). Given that the pharmaceutical formulation of the instant claims minimally requires an at least 100 mg/mL of an anti-IgE antibody, a buffer, arginine or salt thereof, and a surfactant at pH 6 to 7 to achieve at least 90% monomer upon storage at 37℃ for 1 month and a viscosity of 10-15 cp, the compositions of Shenoy which encompass the formulations of the instant claims will necessarily yield the same intended result. 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). Thus, the therapeutic protein agent formulations can be prepared in a manner suitable for use in pre-filled syringes. While the exact preparation process is not disclosed, it is noted that the claims are directed to a product not a process. The patentability of a product does not depend on its method of production. 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 MPEP 2113).
Thus, Shenoy meets the limitations of instant claims 1 and 3-16.
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 and 3-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending Application No. 18926965.
This is a provisional nonstatutory double patenting rejection.
The co-pending claims recite a pre-filled syringe comprising a pharmaceutically 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, 3-7, 10-14, 37, and 38). Further disclosed is a method of treating asthma, urticaria, allergy, or chronic idiopathic urticaria in a patient comprising administering the pharmaceutical liquid formulation (co-pending claims 21-22). The pharmaceutical liquid formulation has a kinematic viscosity of about 10cs or 20 cs or less (co-pending claims 22-23). The pharmaceutically stable liquid formulation comprises at least 98% monomer [of omalizumab] upon storage at 37℃ for 1 month (co-pending claim 1). Further, given that the pharmaceutical formulation of the instant claims 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 at least 98% of the omalizumab to be present as omalizumab monomer following storage as measured by SEC, the compositions of the co-pending claims will necessarily yield the same intended result.
Thus, the co-pending claims meet the limitations of instant claims 1 and 3-16.
Response to Arguments
Applicant's arguments filed 09/25/2025 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 does not teach that the pharmaceutically stable liquid formulation is obtained by filtering bulk solution with 0.2 um filter to get filtrated solution and filled filtered solution in glass pre-filled syringe (PFS).
In response to Applicant’s argument, the Examiner notes that Shenoy teaches 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 disclosed. Thus, the therapeutic protein agent formulations of Shenoy can be prepared in a manner suitable for use in pre-filled syringes. While the exact preparation process is not disclosed, it is noted that the claims are directed to a product not a process. The patentability of a product does not depend on its method of production. 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 MPEP 2113).
Thus, the rejection under 35 U.S.C. 102 is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIA TAYLOR whose telephone number is (571)272-6336. The examiner can normally be reached 8:30 - 5:00 M-F.
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/LIA E TAYLOR/Examiner, Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641