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 .
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, and 9-11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by U.S. Patent No. 4895806 by Le et al. (Le).
In regard to claim 1, Le teaches a chromatography device (Figure 5). Le teaches a housing having an inlet and an outlet (Figure 5, formed by end plates 26, 28, 29; C5/L28-56). Le teaches at least two layers of media disposed between the inlet and the outlet inside of the housing forming a media stack (Figure 5; C5/L28-56; plurality of membrane discs 32). Le teaches at least one of the layers comprises a functionalized layer (Figure 5; C5/L28-56; plurality of membrane discs 32). Le teaches a spacer ring disposed between the at least two layers of media forming an air gap between them (C5/L36-50, gaskets 33).
In regard to claim 3, Le teaches the media stack comprises a functionalized nonwoven layer, another functionalized nonwoven layer, and the spacer ring disposed between them (Figure 5; plurality of membrane discs 32, gasket 33).
In regard to claim 9, Le teaches the housing comprises a compression extension and a boss each having a distal surface that touches the media stack and a pinching projection is located on at least one of the compression extension or the boss (Figure 5, end plate 26, securing rings 30; C5/L36-50 ).
Regarding limitations recited in the claims which are directed to a manner of operating disclosed chromatography device, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). This applies to the following limitations: “the media stack in the chromatography device when using the spacer ring has an increase in a DBC of at least 10 percent when testing either a CL- DBC or a BSA DBA of the chromatography device as compared to the same media stack in a control chromatography device not having the spacer ring” (claim 10); “the DBC increases at least 40 percent” (claim 11).
Additionally, regarding limitations recited in claims 10-11 which are directed to specific properties of chromatography device recited in said claim, it is noted that once a chromatography device is disclosed to comprise a housing having an inlet and an outlet, two layers of media disposed between the inlet and outlet, a functionalized layer, and a spacer ring creating an air gap, and therefore is the same as the chromatography device of the claims, it will, inherently, display recited properties. See MPEP 2112.
Claim Rejections - 35 USC § 103
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4895806 by Le et al. (Le), as noted above.
In regard to claims 6-7, Le teaches the limitations as noted above. Le does not teach the spacer ring has a height creating the air gap and the height is from 0.001” to 1.0” inches or from 0.030” to 0.050” inches.
As the chromatography device cost of construction, layer compression, and efficiency of operation are variables that can be modified, among others, by adjusting said air gap height, the precise air gap height would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed air gap height cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the air gap height in the apparatus of Le to obtain the desired balance between the construction cost, layer compression and the operation efficiency (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4895806 by Le et al. (Le), as noted above, in view of U.S. Patent Publication No. 2010/0155323 by Weiss et al. (Weiss).
In regard to claim 5, Le teaches the limitations as noted above. Le does not teach the functionalized layer is a nonwoven.
Weiss teaches a functionalized nonwoven ([0101], [0111], [0114]). It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to utilize the functionalized nonwoven of Weiss in the apparatus of Le because nonwoven material is a known substrate for filtering.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4895806 by Le et al. (Le), as noted above, in view of U.S. Patent Publication No. 2002/0014449 by Rios et al. (Rios).
In regard to claim 8, Le teaches the limitations as noted above. Le does not teach the spacer ring comprises a material as claimed.
Rios teaches analogous separation systems, Rios teaches a vibratory separation system for providing enhanced filtration (abstract; [0019]). Rio teaches plaster inner and outer seals 240 and 242 (spacer ring) formed of a rigid polymeric material such as polyethylene ([0101], [0123]). It would have been obvious to one of ordinary skill in the art to form the spacer ring of a rigidi polymeric material such as polyethylene since the polyethylene is known as a suitable adhesive/sealant which would serve to seal and bond the layers of the media stack together.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4895806 by Le et al. (Le), as noted above, in view of U.S. Patent Publication No. 2010/0155323 by Weiss et al. (Weiss), and further in view of WO 02/05934 by Geibel.
In regard to claims 2 and 4, modified Le teaches the limitations as noted above. Further, Weiss teaches the media stack comprises a functionalized nonwoven layer ([0101], [0111], [0114]). Weiss teaches a membrane layer (124; [0098]-[0099]). It would have been obvious to one of ordinary skill in the art to modify the device of Le by incorporating a functionalized membrane layer, as taught by Weiss, into the media stack for the benefit of providing an additional membrane layer onto which applications can be run and purified.
Modified Le does not teach a spacer ring between the functionalized nonwoven layer and the functionalized membrane layer or a second spacer ring.
Geibel teaches a membrane packed assembly with two spacer rings disposed between the layers (P10/L27 to P11/L32; Figure 6). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to further incorporate a first and second spacer ring between the layers for the benefit of providing a resilient seal to effectively compress the layers of the media stack.
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 1-8 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-19 of copending Application No. 17998525. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed towards the same device with the same components. Claim 13 of ‘525 reads on instant claim 1; Claim 14 of ‘525 reads on instant claim 2; Claim 15 of ‘525 reads on instant claim 3; Claim 16 of ‘525 reads on instant claim 4; Claim 17 of ‘525 reads on instant claim 5; Claim 18 of ‘525 reads on instant claim 6; Claim 18 of ‘525 reads on instant claim 7; Claim 19 of ‘525 reads on instant claim 8; Claim 19 of ‘525 reads on instant claim 10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
In regard to the Applicant’s argument Le does not teach a functionalized layer in Figure 5, C5/L28-56; the term “functionalized layer” is defined in the specification as a layer that will attract target particles or molecules by attractive forces such as electrostatic forces due to the presence at the surfaces of that layer of one or more chemical moieties, ligands, or functional groups that are distinct from the materials forming the bulk of the layer which are providing primarily its structural shape and integrity; Le teaches membrane discs without any disclosure of chemical functionalization; the Examiner does not find this persuasive.
As noted above: Le teaches at least two layers of media disposed between the inlet and the outlet inside of the housing forming a media stack (Figure 5; C5/L28-56; plurality of membrane discs 32). Le teaches at least one of the layers comprises a functionalized layer (Figure 5; C5/L28-56; plurality of membrane discs 32).
The claims require “at least one of the layers comprises a functionalized layer”.
The instant specification requires a “functionalized layer” is a layer that attracts target particles or molecules by attractive forces due to presence at surface of chemical moieties, ligands, or functional groups.
Le teaches separation medium with a ligand chemically bonded to matrix (C1/L29-47). Le teaches the membrane has a ligand bound thereto (C2/L9-21; C3/L8-11; C3/L37-48; C5/L25-27).
In regard to the Applicant’s argument Le does not disclosure an air gap between the two layers formed by the spacer ring; the Examiner does not find this persuasive.
As noted above: Le teaches a spacer ring disposed between the at least two layers of media forming an air gap between them (C5/L36-50, gaskets 33).
See Figure 5 below which has been annotated to show the air gap formed by the spacer ring.
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Conclusion
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 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.
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/KARA M PEO/Primary Examiner, Art Unit 1777