DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendment and response filed on 8/10/2026 have been received and entered into the case. Claims 2, 6 and 7 have been canceled. Claims 1, 3-5 and 8-13 are pending and have been considered on the merits. All arguments have been fully considered.
Withdrawn Rejections
Rejections of Claims 1, 3-5, 8-9, and 11 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Belew et al (US 2005/0267295 A1; 12/1/2005. Cited on IDS) in view of Octylamine (gelifesciences.com. 2008;1-18. Cited on IDS), as evidenced by Mahoney (Newton’s Home Page. 2003;1-2. Cited on IDS) are withdrawn in view of applicant’s amendments.
Rejections of Claim 10 under 35 U.S.C. 103(a) as being unpatentable over Belew et al (US 2005/0267295 A1; 12/1/2005. Cited on IDS) in view of Octylamine (gelifesciences.com. 2008;1-18. Cited on IDS) and Bruker Daltonics (www.care-bdal.com. 2006;1-6. Cited on IDS), as evidenced by Mahoney (Newton’s Home Page. 2003;1-2. Cited on IDS) are withdrawn in view of applicant’s amendments.
Rejections of Claims 12-13 under 35 U.S.C. 103(a) as being unpatentable over Belew et al (US 2005/0267295 A1; 12/1/2005. Cited on IDS) in view of Octylamine (gelifesciences.com. 2008;1-18. Cited on IDS) and Maa et al (Journal of Chromatography. 1988;452:331-345. Cited on IDS), as evidenced by Mahoney (Newton’s Home Page. 2003;1-2. Cited on IDS) are withdrawn in view of applicant’s amendments.
NOTE: Canceled claim 2 is missing a claim number.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-5 and 8-13 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No 11,439,926 B2 (referred to as the ‘926 patent) in view of Maa et al (Journal of Chromatography. 1988;452:331-345. Cited on IDS).
Claims 1-6 of the ‘926 patent recite an agarose-based separation medium, comprising a hydrophobic porous core entity with octylamine ligands having a ligand density of greater than 90 μmole/mL, and a porous hydrophilic lid (a non-binding lid) covering the whole outer part of the core entity, wherein the lid only allows molecules under 60,000D to penetrate and absorb onto the hydrophobic octyl ligands of said core entity of the separation medium, wherein the hydrophobic core entity allows adsorption of molecules under 60,000D at low ionic strength 0-1M in the pH interval 2-11, wherein magnetic particles are incorporated into the core entity, wherein a dextran hydrogel is provided in the lid to fill the pores of the lid and thereby further decrease and adjust the pore size of the lid, and wherein at least one of the lid and core entity are functionalized by layer activation.
Claim 4 is regarded as intended use limitation. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103. (MPEP 2112)
The ‘926 patent does not teach the separation medium is mixed with chromatography media such as a cation exchange media as well as the claimed separation medium concentration (claims 12-13).
Maa teaches mixed-bed ion-exchange columns (e.g., cation exchangers) for protein high-performance liquid chromatography (Title), wherein important applications for mixed-sorbent columns are expected to be found in the burgeoning field of preparative chromatography (p.342 para 5). This approach not only permits the manipulation of selectivity for separation of the desired product but also make the use of difficult-to-remove mobile phase additives superfluous (p.342 para 5).
Thus, at the time of the claimed invention, it would have been obvious to one of ordinary skill in the art to mix a separation medium with a cation exchange media as well as to optimize the separation medium concentration, since Maa discloses that mixed-bed ion-exchange columns offer certain advantages in displacement and in other non-linear chromatographic techniques (p.342 para 5). Moreover, at the time of the claimed invention, it would have been within the purview of one of ordinary skill in the art to mix a separation medium with a cation exchange media as well as to optimize the separation medium concentration with a reasonable expectation of success.
Claims 1, 3-5 and 8-13 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent No 10,493,380 B2 (referred to as the ‘380 patent).
Claims 1-11 of the ‘380 patent recite a method for separating at least one target substance from a sample, the method comprising, applying a sample comprising at least one target substance onto an agarose based separation medium, wherein the at least one target substance is selected from a virus and an antibody, and wherein said separation medium comprises a porous core entity functionalized with hydrophobic octylamine ligands having a ligand density of greater than 90 μmole/mL, and a porous hydrophilic lid (a non-binding lid) covering the core entity (the lid or core entity is functionalized by layer activation), allowing molecules having a size of <60,000 D from the sample to penetrate the hydrophilic lid and absorb onto-the hydrophobic octylamine ligands of said core entity of the separation medium to remove these molecules from the sample, and obtaining said target substance in a flow-through fraction of the sample. The sample comprises at least one of DNA and proteins which absorb onto said hydrophobic octylamine ligands in the core entity of the separation medium and are separated from said target substance in the flow-through fraction of the sample, and the sample comprises host cell proteins (allows adsorption of low molecular weight molecules or small size molecules at low ionic strength 0-1M in the pH interval 2-11). The method further comprises providing a hydrogel to said lid, wherein said hydrogel fills pores within said lid, thereby further decreasing and adjusting the size of said pores to prevent high molecular weight target substance from entering said pores. Magnetic particles are incorporated into said core entity. The separation medium is mixed with a cation exchange chromatography media and said separation medium comprises up to 10% of the total volume of the combined separation medium and the chromatography media.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
