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 .
Response to Amendment
The amendment filed 3/20/2026 has been entered. Claims 4, 5, 9, 18, and 19 have been cancelled. New claim 21 has been added. Claims 1-3, 6-8, 10-17, 20, and 21 are pending in the application. Claim 20 stands withdrawn as directed to a non-elected invention.
The 112(b) rejections previously set forth are withdrawn in view of the amendments.
Response to Arguments
Applicant's arguments filed 3/20/2026 have been fully considered but they are not persuasive or are addressed with the modified ground of rejection below in view of McRea; as in the rejections of record, arrangements in which a section with one type of separation material e.g. a first type of adsorbent media are separate from other media would at least have been obvious in view of Ward and the proposed “parfait” arrangement for treatment stages, and further the use of retention screens to prevent adsorbent media from exiting a particular adsorbent section and entering an adjacent hollow fiber section (e.g. a hemo-concentrator section) would have been obvious in view of McRea, which teaches system employing such arrangements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries 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 1-3, 6-8, and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Heinrich (WO 2006/012885) in view of Ward et al (US PGPub 2011/0184377 A1) and McRea et al (US 5,858,238 A).
With respect to claims 1 and 11, Heinrich teaches filter media and filter devices containing such media, where the media includes a combination of hollow fiber membranes and adsorptive media [0037-0039, 0041]. Heinrich teaches that the adsorption media may be specifically or non-specifically functionalized [0041] but does not explicitly teach the nature of this functionalization or base material e.g. the use of surface-coated solid substrate, coated with heparin or the like.
However, Ward teaches media for treatment of blood [Abs] with particular binding affinities, and teaches that a desirable configuration is a surface-coated solid substrate such as a bead or similar particle [0025, 0028-0031] and which may beneficially be functionalized with polysaccharides such as heparin [0010].
It would have been obvious to one of ordinary skill in the art to employ surface-coated solid materials such as the particles or beads taught by Ward, specifically coated with heparin as suggested by Ward, to function as the adsorption media in Heinrich’s taught invention because Heinrich does not particularly limit the specific details and simply employs functionalized particle media, and in view of Ward the benefits of beads or the like and specific functionalities to accomplish the desired goal of treatment of e.g. blood would be recognized.
Heinrich and Ward are silent to the provision of a screen or retention filter disposed between the hollow fiber membrane and adsorption media. Ward teaches a “parfait-type” arrangement employing different types of media with different functionalities for series or parallel contact, including e.g. separated layers at the entrance and exit regions, and potentially mixed media intermediate to the two [0052], where the media may have the same or different functionalities e.g. antithrombogenic surfaces vs. thrombogenic surfaces [0048-0052], where such media may include beads but also may include hollow fibers or various membrane configurations; however, no particular screen or retention means are specified.
However, McRea teaches systems for blood processing [Abs] when employ sorbent-containing plasma separators for solute removal as well as hollow-fiber based hemo-concentrators for ultrafiltration and similar purposes, and teaches that the hemo-concentrator (204) may be fluidically positioned between first and second solute removal devices (208), (212) [Figs. 4-5, Col. 12 lines 33-65] and that in this configuration, there is preferably provided a fine mesh screen at the fluid ports (252), (268) of the devices (208), (212) which retain the sorbent media within them [Col. 13 lines 25-27]. It would have been obvious to incorporate similar retention structures in the modified system of Heinrich and Ward, particularly when implementing a layered/”parfait” arrangement suggested by Ward, to retain relevant sorbent media in its own section and not allow it to migrate to adjacent sections, including hollow-fiber based sections which may be employed for ultrafiltration or concentration or other purposes.
With respect to claims 2, 3, 16, and 17, Heinrich teaches polysulfone, polyacrylonitrile, and other polymers may be employed for forming the hollow fiber membranes [0041].
With respect to claim 6, Ward further teaches heparan sulfate as well as other useful molecules such as PEI and various carbohydrates and polysaccharides [0048] which may enhance removal of harmful substances.
With respect to claims 7 and 8, Heinrich teaches as above but is silent to the surface area of the adsorption media. However, see MPEP 2144.04 IV.A; changes in size of a device represents an obvious engineering choice for one of ordinary skill in the art, e.g. to scale the device up or down to useful sizes. Providing a filter device of an appropriate scale and containing an appropriate amount of adsorption media to provide the claimed surface area represents an obvious change in size for one of ordinary skill in the art.
Similarly, the size of the media particles relative to the diameter of the hollow fiber represents an obvious change in size or proportion, e.g. to balance effective relative surface areas of the two media; Heinrich already requires that the media particles are larger than the pores of the hollow fiber so as to be retained/excluded by the fiber walls.
With respect to claim 10, as above Heinrich teaches particles which may or may not satisfy the requirement for beads but, regardless, Ward explicitly teaches employing beads as above.
With respect to claim 12, Heinrich teaches a filter device with a housing, first and second end caps, and media disposed therebetween [Fig. 2].
With respect to claims 13, Heinrich teaches that the system may include separate sections e.g. a section with hollow fibers (A) and a section with mixed media (B) [0047]. Further, in any particular cross section, a hollow fiber surrounded on multiple sides by adsorber media may constitute a sandwich as claimed. Regardless, provision of a sandwich structure would have been obvious in view of Ward, which teaches a “parfait-type” arrangement employing different types of media with different functionalities for series or parallel contact, including e.g. separated layers at the entrance and exit regions, and potentially mixed media intermediate to the two [0052], where the media may have the same or different functionalities e.g. antithrombogenic surfaces vs. thrombogenic surfaces [0048-0052], where such media may include beads but also may include hollow fibers or various membrane configurations.
As such, extending the layered sections taught by Heinrich to include at least three sections in a sandwich or “parfait-type” arrangement would have been obvious in view of Ward, to gain the benefit of providing regions with either mixed media or discrete media having e.g. different functionalities at different parts of the cartridge.
With respect to claim 14, as above the system as suggested by Ward may employ the media in mixed form such that the same materials may be employed in different layers. Examiner notes that, considering a cross section of a region in which hollow fibers are surrounded by beads on multiple sides, the same material on both sides would apply even to discrete layers of adsorption media e.g. in the packed fiber column section of Heinrich.
With respect to claim 15, as above the system as suggested by Ward may employ media in discrete layers such that different materials may be employed in different layers. Examiner notes that, considering a cross section of a region in which hollow fibers are surrounded by beads on multiple sides, different material on both sides would apply to mixed layers of adsorption media e.g. in the packed fiber column section of Heinrich.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Heinrich in view of Ward et al.
See the rejections of claims 1, 7, 8, and 11 above; the combination of Heinrich and Ward render obvious the use of hollow fibers and adsorption media in combination, where such adsorption media are beads with surface coated heparin; selection of appropriate relative sizes e.g. of media vs. fiber diameter represent obvious changes of size to balance effective values such as surface areas available for adsorption and separation and the like, relative to available volume.
Regarding the diameter of the beads, at least Ward suggests that useful beads of similar make are available in sizes ranging from about 100-500 microns [0033], such that employing beads within that range (which overlaps and thus renders obvious the claimed range) would have been obvious in the combined system.
Claims 1-3, 6-8, and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al (US PGPub 2003/0231981 A1) in view of Heinrich, Ward et al, and McRea et al.
With respect to claims 1 and 11, Johnson teaches systems, methods, and media for selectively binding and separating components from whole blood which employ various layers of media in a housing [0072] using active surfaces of various porous media [0070] which have been coated or otherwise surface-modified [0026]. The media are designed to remove substances using functional interactions rather than size-exclusion such that adsorptive media is implicit or at minimum obvious. Johnson does not explicitly require that any of the layers employ hollow fiber membranes.
However, as discussed above, both Heinrich and Ward teach that hollow fiber membranes may be employed in similar devices with similar purposes (i.e. blood treatment or the like) either in combination with, or directly as a component of, an adsorptive media. As such, providing a set of hollow fibers for at least one of the media layers taught by Johnson as a porous media which may be functionalized or may be used in combination with functionalized media would have been obvious to one of ordinary skill in the art.
Regarding the use of surface coated heparin, as discussed above such limitation is at minimum obvious in view of Ward. Regarding the use of screens to separate regions i.e. to isolate adsorbent in one region from an adjacent region containing hollow fibers, as discussed above such limitation would have been obvious in view of McRea which employs screens for the same general purpose in systems in which a hollow fiber concentrator section is placed between two adjacent adsorbent sections.
With respect to claims 2, 3, 16, and 17, Johnson teaches polymers may be employed for various porous media including PMMA, PAN, PP, polysulfones, and the like [0037].
With respect to claim 6 Johnson teaches that the coated material may include ligands e.g. proteins, carbohydrates, or similar materials [0051] but also that materials such as PEI having useful functional groups may be employed [0045].
With respect to claims 7 and 8, see the discussion above; changes in size are obvious to those of ordinary skill in the art, and selecting a size of media to obtain a desired surface area (and relative areas of different types of media) represents an obvious change in size or proportion for one of ordinary skill in the art.
With respect to claim 10, as above the use of beads would have been obvious at least in view of Ward.
With respect to claims 12-15, Johnson teaches arrangements with first and second end caps having suitable connections, and media layers in between e.g. in sandwich configurations; see e.g. [Fig. 3c]. Regarding the specific order of the layers, see MPEP 2144.04 IV.C and VI.C; rearrangement of parts, and rearrangements of the sequences in which process steps would be performed, are obvious to those of ordinary skill in the art. See further the discussion of Heinrich and Ward above; providing sections with e.g. media below a hollow fiber section, or providing discrete sections at the top and bottom of a device, represent obvious configurations for such devices as contemplated in the prior art. Selecting the same or different media layers would have been an obvious way to provide desired overall volumes of particular treatment types while also allowing multiple functionalities to be combined in the same device, as is the overall purpose of the device of Johnson.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al in view of Heinrich, Ward et al.
See the rejections above. The claimed invention would have been obvious over the proposed combination e.g. incorporating fibers as in Heinrich and/or Ward, heparin coating as in Ward, and providing suitable optimization of sizes e.g. to balance surface areas and treatment regions vs. available volume. Further, the specific range of sizes for beads would have been obvious in view of Ward, which teaches an overlapping range for beads which are useful for this type of adsorbent material.
Conclusion
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 BRADLEY R SPIES whose telephone number is (571)272-3469. The examiner can normally be reached Mon-Thurs 8AM-4PM.
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/BRADLEY R SPIES/Primary Examiner, Art Unit 1777
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