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 .
Claim Status
The Preliminary Amendment filed on 12 May 2026 has been entered; claims 1-20 remain pending.
Response to Arguments
Applicant’s arguments, see Pages 7-8 of the Remarks, filed 12 May 2026, with respect to the rejections of claims 2, 3, and 14 under 35 USC 112(d) have been fully considered and are persuasive. The rejections of claims 2, 3, and 14 under 35 USC 112(d) have been withdrawn.
Applicant's arguments, see Pages 8-9 of the Remarks, filed 12 May 2026, with respect to the 103 rejections of claims 1-20 have been fully considered but they are not persuasive. Applicant argues on Page 9 regarding the arrangement of first and second matrices with respect to fluid flow is not found to be persuasive, as modification of second media layer 5b of Johnson with Bell’s particles which bind the same endotoxin component meets the limitations of flow directionality as recited, which the Examiner submits does merit patentable weight in any event, as these limitations are directed to a method of use/particular application of the matrix layers of the device of Johnson in view of Bell.
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.
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.
Claims 1, 2, 4-8, and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (WO 03/090924) in view of Bell et al. WO 01/23413), hereinafter “Johnson” and “Bell”.
With respect to claims 1 and 2, Johnson teaches a device 1 (see Fig. 1; Page 15, line 29 through Page 16, line 5) for removal of at least one component from a body fluid (Abstract) comprising a proximal end (bottom end in Fig. 1), a distal end (top end in Fig. 1), a housing 2, and inlet 3 disposed at the proximal/bottom end; an outlet 4, at least one sheet or disc of a first matrix (Page 16, lines 11-14) having a porous structure, for example as 5a (Page 16, lines 16-19; Fig. 1), which is used for endotoxin (“the first component”) removal (see Page 14, lines 6-9; Page 31 Ex. 33: which discloses deoxycholate (DOC) as the moiety which was immobilized on plasma modified polyethylene matrix via a spacer of diaminohexane).
Johnson teaches additional separation matrices (see Fig. 1; 5b-5e), but does not specifically teach a plurality of beads of a second matrix.
Bell teaches a media comprising a plurality of beads (“second matrix”) (see Page 5, lines 13-20; Examples 1 and 2 on Pages 10-11; Claim 8), used for endotoxin removal (see Abstract; Claims 6, 8, 10; the endotoxin of Bell being “the second component”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to add the plurality of beads (“second matrix”) of Bell to one of the media layers of Johnson because the media components 5a-5e of the device of Johnson can be represented in a variety of forms (see Page 16, lines 11-15) and that the matrix layers 5a-5e of the device of Johnson removes endotoxins (see Page 14, lines 6-9; Page 31 Ex. 33), and because Bell teaches that the plurality of beads (“second matrix”) comprise amino acid ligands (“moiety that specifically binds the second component”) that are selective for endotoxins (see Abstract; Claims 6, 8, 10).
With respect to the limitations “for binding and separation of at least one component from a body fluid”, “(a first matrix) for binding of a first component from the body fluid”, “(a second matrix for binding of a second component from the body fluid”, and “wherein the first component and the second component is at least one of the same and different”, the Examiner submits that these are intended use limitations which are not assigned patentable weight in device claim 1. The device of Johnson in view of Bell is capable of these intended use limitations as the components of the body of claim 1 are met.
Nevertheless, Johnson in view of Bell also teaches all of these intended use limitations, wherein the first and second component is endotoxins which are removed from a body fluid (see Abstract of Johnson and Abstract of Bell, and the preceding paragraph for endotoxin binding and separation).
Regarding the limitations pertaining to the arrangement of first and second matrices such that body fluid flows in a direction such that the body fluid flows through the first matrix before the plurality of beads of the second matrix, the above modification placing the second matrix of the plurality of beads at media 5b accomplishes these intended use limitations.
With respect to claim 4, Johnson in view of Bell teaches that the first component is LPS (see Example 33 of Johnson on Page 31), which is bound by deoxycholate (DOC) which was immobilized on plasma modified polyethylene matrix via a spacer of diaminohexane, wherein the DOC specifically binds the LPS endotoxin (see Example 33 on Page 31 of Johnson).
With respect to claim 5, Johnson in view of Bell teaches an LPS-binding peptide having up to 20 arginine amino acid units (see Bell: Page 8 line 11 through Page 9, line 10), whereas amino acid sequence 3 comprises 63% arginine units. Although 80% homology is not present, it is submitted that there does not appear to be any criticality associated with 80% homology with Seq ID 3. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Johnson in view of Bell teaches that the separation matrix comprising this LPS binding peptide can be fashioned as a membrane (considered to be consistent as a “sheet”). It would have been obvious to the ordinary artisan to add a membrane comprising LPS-binding peptide as an additional layer of the endotoxin-removing separation matrices disclosed in Fig. 1 of Johnson, as LPS is an endotoxin and is selectively removed by both references as sheets or beads (only Bell).
With respect to claims 6 and 7, Johnson in view of Bell teaches that the first matrix comprises plasma-modified polyethylene (see Johnson Example 33 on Page 31), which is described in Examples 25 and 3 in more detail, which can be obtained via polymer foaming, molding, or sintering (see claims 1 and 9; Page 7, lines 14-24).
With respect to claim 8, Johnson in view of Bell teaches that the second matrix comprises an oligopeptide embodied a polyarginine that specifically binds the endotoxin (“second component”) (see Bell: Page 8, line 11 through Page 9, line 16, and see Examples 1 and 2 on Pages 10-11 of Bell).
With respect to claim 10, Johnson in view of Bell teaches beads having a diameter of 140 microns, a discrete value within “20 to 1,500 µm” (see Bell: Example 1 Page 10, lines 25-26).
With respect to claims 11-17, Johnson in view of Bell teaches a plurality of porous separation matrices 5a-5e, wherein if the first matrix is layer 5a disposed at the proximal end and matrix 5b is the plurality of beads as discussed above in claim 1, it would have been obvious to the ordinary artisan that separation matrix 5c could be another sheet or disc of the first matrix and separation matrix 5d (“fourth matrix”) could be another layer of the plurality of beads, wherein the third and fourth matrices also capable of immobilizing endotoxins, and wherein the first sheet or disc matrix is spaced from the third disc or sheet matrix by a layer 5b of the plurality of beads, and wherein the third and fourth matrices would have the same moiety for binding third and fourth components which are embodied as endotoxins to be removed from the body fluid.
With respect to claim 18, Johnson in view of Bell teaches separation matrix 5e (“fifth matrix”); it would have been obvious to the ordinary artisan that separation matrix 5c could be another sheet or disc of the first matrix for adsorption of endotoxins (“hydrophilic component”). Regarding the recited sixth media, it would have been obvious to add another layer of the plurality of beads of Bell in order to adsorb cytokines (proteins, “hydrophilic component”) and/or in order to removal additional endotoxins (“hydrophilic component”) that were not removed by the previous layers of separation matrix 5a-5e, and because Johnson envisions additional layers of separation matrices 5a-5g (See Fig. 3).
With respect to claim 19, Johnson teaches a method for binding and separating endotoxins (“at least one component”) from blood or a body fluid” (Abstract) comprising:
providing device 1 (see Fig. 1; Page 15, line 29 through Page 16, line 5), wherein the device 1 comprises a proximal end (bottom end in Fig. 1), a distal end (top end in Fig. 1), a housing 2, and inlet 3 disposed at the proximal/bottom end; an outlet 4, at least one sheet or disc of a first matrix (Page 16, lines 11-14) having a porous structure, for example as 5a (Page 16, lines 16-19; Fig. 1);
introducing blood or a body fluid through the inlet 3 of device 1 (see Fig. 1 for fluid flow direction and Page 15, line 29 through Page 16, line 5);
binding a first component including endotoxins to a first matrix by passing the body fluid through the first matrix (Page 15, lines 16-24);
and collecting the body fluid from outlet 4 (see for Example, Ex. 30: wherein collected blood is tested for reduction in neutrophils and monocytes). It would have been obvious to the ordinary artisan to consult the Example embodiments provided and to collect the body fluid from any separation process utilizing device 1, in order to determine the separation efficiency.
Johnson teaches additional separation matrices (see Fig. 1; 5b-5e), but does not specifically teach a plurality of beads of a second matrix of device 1 or binding of a second component as claimed.
Bell teaches a media comprising a plurality of beads (“second matrix”) (see Page 5, lines 13-20; Examples 1 and 2 on Pages 10-11; Claim 8), used for endotoxin binding and removal (see Abstract; Claims 6, 8, 10).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to add the plurality of beads (“second matrix”) of Bell to one of the media layers (say, 5b) of Johnson because the media components 5a-5e of the device of Johnson can be represented in a variety of forms (see Page 16, lines 11-15) and that the matrix layers 5a-5e of the device of Johnson removes endotoxins (see Page 14, lines 6-9; Page 31 Ex. 33), and because Bell teaches that the plurality of beads (“second matrix”) comprise amino acid ligands that are selective for endotoxins (see Abstract; Claims 6, 8, 10).
With respect to the limitations “for binding and separation of at least one component from a body fluid”, “(a first matrix) for binding of a first component from the body fluid”, “(a second matrix for binding of a second component from the body fluid”, and “wherein the first component and the second component is at least one of the same and different”, Johnson in view of Bell teaches these limitations, wherein the first and second component are endotoxins which are removed from a body fluid (see Abstract of Johnson and Abstract of Bell, and the rejection of claim 1).
Regarding claim 20, the above medication results in flow from inlet 3, first matrix 5a, second matrix 5b, and outlet 4 (see Fig. 1).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (WO 03/090924) in view of Bell et al. WO 01/23413) as applied to claim 1 above, or, in the alternative, further in view of Zhang et al. (CCS Chemistry, 2020, 2, 376-389), hereinafter “Johnson”, “Bell”, and “Zhang”.
With respect to claim 3, Johnson in view of Bell teaches that the first component is LPS (see Example 33 of Johnson on Page 31), and the second component is a endotoxin or cytokine-inducing components (see Abstract of Bell), and therefore does not teach that the second component is embodied as claimed; however, the first and second components are associated with a particular method of use of the device recited in claim 1, and therefore are not assigned patentable weight.
Assuming the Examiner is incorrect regarding the above obviousness analysis, the rejection is continued below in view of Zhang.
Zhang teaches capturing inflammatory cytokines on cell membrane coated nanoparticles (Title, Abstract).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to add the cell membrane coated nanoparticles of Zhang to an adjacent media layer of the first matrix of Johnson because Johnson teaches media that can remove cytokines and speaks to the advantages of media in bead form which allow for passage of blood cells between the beads with a porous support material (see Johnson: Page 3, line 33 through Page 4, line 5; Page 5, lines 22-28), as in the first matrix taught by Johnson, and because Zhang teaches that excessive production of inflammatory cytokines contributes to the destructive components responsible for various inflammatory disorders (Abstract).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (WO 03/090924) in view of Bell et al. WO 01/23413) as evidenced by POROS EP, 2017, Pages 1-6), hereinafter “Johnson”, “Bell”, and “POROS EP”.
With respect to claim 9, Johnson in view of Bell teaches that the beads can be embodied as POROS EP, a polymer packing that consists of cross-linked poly(styrene-divinylbenzene) flow-through particles (see POROS EP: Page 1: Product description first paragraph). POROS EP is one of eight example beads disclosed by Johnson in view of Bell (see Page 10, lines 1-12); one of ordinary skill in the art at the time of the claimed invention would have found it “obvious to try” POROS EP as the teaching represents a finite number of identified, predictable combinations. KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
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.
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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/CLARE M. PERRIN/
Primary Examiner
Art Unit 1779
/CLARE M PERRIN/Primary Examiner, Art Unit 1779 23 July 2026
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