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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed 0n 13 January 2026.
Claims 1-12 and 14-23 are pending.
Claim 13 is canceled.
Claims 12 and 14-22 are withdrawn.
Claim 23 is newly added.
Claim Interpretation
Regarding Claims 1-4, 6, 9, and 11, the claims recite the mesh having “spaces” wherein this term is interpreted as meaning the mesh having “openings” or “pores”.
Claim Rejections - 35 USC § 103
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 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US PAT 4,954 251 A), hereinafter “Barnes”, in view of Weilbacher et al. (US PAT 5,925,025 A), hereinafter “Weilbacher”.
Regarding Claim 1, Barnes teaches an apparatus configured to receive particles in a liquid (Fig. 3), comprising:
a housing 16 comprising a housing inlet 18 and a housing outlet 20 (Fig. 3 and [col. 6, line 59]: “FIG. 3 is a cross-section illustration showing very generally how blood flows in the filter of this invention. FIG. 3 shows a housing 16 made from a flexible, preferably transparent material such as plasticized PVC. Housing 16 has inlet 18 and outlet 20 ports.”);
and a mesh 24 located in the housing 16 between the housing inlet 18 and the housing outlet 20 (Fig. 3 and [col. 6,line 63]: “Incoming blood flows to an inner pre-filter 24 of about 150μ mesh within an outer concentric outer microaggregate filter 26 of about 40μ mesh pore size. Such screens can be made from commercially available square mesh, monofilament polyester materials (PeCap® screen, Tetko, Inc., Elmsford, N.Y.).”),
the mesh 24 having spaces greater than a greatest transverse dimension of the particles ([col, line]: “As blood flows into inner pre-filter 24, clots and aggregates 32 larger than about 150 microns tend to be held back and sediment toward the bottom of the interior of inner pre-filter 24. Blood material smaller than 150 microns flows relatively unobstructed through pre-filter 24...” – As blood cells/small aggregates are discussed as passing through the filter 24, the mesh spaces must necessarily be greater than the blood cells/small aggregates passing therethrough, so as to enable said passing.),
wherein: the particles have a propensity to agglomerate (col. 1, lines 11-39 – Examiner further notes that the “particles” are not a positively claimed structural element of the device and are drawn to an intended workpiece not given particular patentable weight.);
as in Claim 1.
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Further regarding Claim 1, Barnes does not specifically teach the apparatus discussed above comprising a pump coupled to the housing outlet, as in Claim 1.
However, Weilbacher teaches a respective microaggregate filter wherein an infusion pump 14 is coupled to the filter outlet port 22 (Figs. 1 and 2, and col. 4, lines 14-32). Therein, this active pumping arrangement assists in alleviating clogs in the fluidic pathways of the device, enabling a positive pushing of blood through the filter enabling the filter to resist clogging, as indicated by Weilbacher (col. 2, line 14), and providing a means for multi-stage filtration not possible through gravity flow (Fig. 2).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Barnes to further include a pump coupled to the housing outlet, such as suggested by Weilbacher, so as to alleviate clogs in the fluidic pathways of the device, enabling a positive pushing of blood through the filter enabling the filter to resist clogging, and providing a means for multi-stage filtration not possible through gravity flow.
Further the Claim 1 recitation: “the pump generates a flowrate of the liquid through the mesh such that large aggregates of the particles, each large aggregate having a transverse dimension greater than each of the spaces of the mesh, break apart when colliding with the mesh into individual particles or small aggregates, each small aggregate having a transverse dimension less than each of the spaces of the mesh”, merely indicates a capability of the pump. It recites a manner in which the pump is used and the intended result that occurs during operation of the pump. A recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from the prior art apparatus of Barnes/Weilbacher having the same structure. Accordingly, the prior art of Barnes/Weilbacher commensurately teaching a filter/pump arrangement as claimed is commensurately capable of performing the recited breaking-apart functions when operated under suitable flow conditions fully within the capability of the pump. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes teaches the apparatus discussed above wherein the spaces are square ([col. 6, line 66]: “Such screens can be made from commercially available square mesh...”), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes teaches the apparatus discussed above wherein the spaces have widths less than 1.3 mm ([col. 7, line 4]: “As blood flows into inner pre-filter 24, clots and aggregates 32 larger than about 150 microns tend to be held back and sediment toward the bottom of the interior of inner pre-filter 24.” – By this, the filter 24 must necessarily comprise a pore size less than or about 150 microns so as to collect aggregates of about 150 microns as taught by Barnes, wherein 150 microns is less than 1.3 mm commensurately as claimed.), as in Claim 3.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes teaches the apparatus discussed above wherein the housing is made of nonmagnetic material ([col. 6, line 61]: “housing 16 made from a flexible, preferably transparent material such as plasticized PVC...” – Standard, unmodified PVC and other flexible organic polymer plastics are non-magnetic.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes does not specifically teach the apparatus discussed above wherein the apparatus is configured to be coupled to a pump having an inlet valve, wherein the inlet valve having a transverse inlet dimension, and wherein the spaces are smaller than the transverse inlet dimension of the inlet valve, as in Claim 6.
However, Weilbacher teaches a respective microaggregate filter comprising an infusion pump 14 having an inlet valve 57 (Fig. 8) coupled to the filter outlet port 22 (Figs. 1 and 2, and col. 4, lines 14-32), wherein the spaces of the filter are smaller than a transverse dimension of the inlet valve (Fig. 9 and col. 6, line 61). Therein, this arrangement provides sufficient inlet diameter to allow for fluid flow while providing a mesh capable of filtering particles flowing through the inlet.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Barnes wherein the apparatus is configured to be coupled to a pump having an inlet valve, wherein the inlet valve having a transverse inlet dimension, and wherein the spaces are smaller than the transverse inlet dimension of the inlet valve, such as suggested by Weilbacher, so as to provide sufficient inlet diameter to allow for fluid flow while providing a mesh capable of filtering particles flowing through the inlet.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes teaches the apparatus discussed above wherein the mesh is made of a nonmagnetic material ([col. 6, line 66]: “Such screens can be made from commercially available square mesh, monofilament polyester materials (PeCap® screen, Tetko, Inc., Elmsford, N.Y.).” – Therein, monofilament polyester materials are a non-magnetic polymer plastic.), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes teaches the apparatus discussed above configured to receive particles in a liquid as recited by Claim 1. Given that Claim 1 recites retaining particles as a mere capability of the claimed apparatus and does not claim and recite the particles as a positive structure of the instant device, the use of magnetic particles with the device is interpreted as a mere intended use. Particles, including the magnetic particles specified herein, are drawn to intended workpieces with the apparatus and are not afforded patentable weight as they are not positively claimed elements of the apparatus. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied. Herein, the prior art apparatus of Barnes is fully capable of use with magnetic particles, given its commensurate disclosure of a housing and particle retaining mesh as discussed above regarding Claim 1.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes in view of Weilbacher, as applied to Claims 1-3 and 5-8 above, and as evidenced through Brunner (Brunner, Patrick; “Mesh Matters”, Special printing worldwide Digital, Screen & Pad Technology, 27 May 2019.), hereinafter “Brunner”.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes teaches the apparatus discussed above wherein the mesh comprises first wires extending in a first direction and second wires extending in a second direction, wherein the first wires are woven together with the second wires, and wherein the spaces are located between the first wires and the second wires ([col. 6, line 66]: “Such screens can be made from commercially available square mesh, monofilament polyester materials (PeCap® screen, Tetko, Inc., Elmsford, N.Y.).” – Barnes teaches the mesh 24 as being a commercially available monofilament polyester mesh, wherein such mesh structures are known in the art as comprising first and second wires woven together at a 90 degree angle to form an array of square openings, as evidenced through Brunner (Fig. 1).), as in Claim 11.
Claims 4 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes in view of Weilbacher, as applied to Claims 1-3 and 5-8 above, and in further view of Brunner. Brunner has been discussed above.
Further regarding Claim 4, Barnes does not specifically teach the apparatus discussed above wherein the spaces have widths in a range from 1.15 mm to 1.25 mm, as in Claim 4.
However, as the mesh particle retention (size of particles held back) is a property that can be modified by adjusting the pore size (the spaces’ size), as evidenced through Brunner (Fig. 1 and Section 2: “Mesh Geometry”: “The combination of thread diameter and mesh opening limits the fineness of the smallest printable dot.”), the precise pore size 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 range of pore sizes cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the pore size to achieve a desired filter retention for an application at hand (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).
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes teaches the apparatus discussed above wherein the mesh includes members located between the spaces (the filaments of the mesh are members which exist between the spaces, separating the spaces.), as in Claim 9.
Further regarding Claim 9, Barnes does not specifically teach the apparatus discussed above wherein the members have thicknesses in a range from 0.127 mm to 0.381 mm, as in Claim 9.
However, as the mesh particle retention (size of particles held back) is a property that can be modified by adjusting the average thickness of monofilaments, as evidenced through Brunner (Fig. 1 and Section 2: “Mesh Geometry”: “The combination of thread diameter and mesh opening limits the fineness of the smallest printable dot.”), the precise monofilament (the members located between the spaces) thickness 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 range of thicknesses of members (monofilaments) located between the spaces cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the monofilament diameter/thickness so as to achieve a desired filter retention for an application at hand (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).
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes does not specifically teach the apparatus discussed above wherein the mesh has an open area in a range from 31% to 41%, as in Claim 10.
However, as the mesh particle retention (size of particles held back) and filtration time (time it takes for liquid to pass through the mesh) are properties that can be modified by adjusting the average open area % of the mesh, as evidenced through Brunner (Fig. 1 and Section 2: “Mesh Geometry”: “The combination of thread diameter and mesh opening limits the fineness of the smallest printable dot...From these basic elements, all other screen printing relevant values result such as mesh thickness (microns), mesh opening (microns) and open area (%)...”), the precise open area % of the mesh 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 range of open area % cannot be considered critical.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the open area % so as to achieve a desired filter retention and filtration time for an application at hand (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 23 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes in view of Weilbacher, as applied to Claims 1-3 and 5-8 above, and in further view of Warkiani et al. (US PAT 10,806,845 B2), hereinafter “Warkiani”.
Regarding Claim 23, the prior art meets the limitations of Claim 1 as discussed above. Further, Barnes does not specifically teach the apparatus discussed above wherein the flowrate is in a range from 0.2 L/min to 0.4 L/min, as in Claim 23.
However, Warkiani teaches a respective blood filtering system where blood is processed through a filtration system driven by an infusion pump, wherein the flow rate is about 200 ml/min so as to rapidly process large amounts of blood (col. 5, line 14).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the device of Barnes/Weilbacher wherein the flowrate is in a range from 0.2 L/min to 0.4 L/min, such as suggested by Warkiani (the recited value in Warkiani of 200 ml/min falling within the claimed range), so as to achieve rapid filtration of large amounts of blood.
Further, as the filtration speed is a property that can be modified by adjusting the flowrate, the precise flowrate value 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 range of average Mn values cannot be considered critical. (Examiner further notes that para. [0034] of the instant specification also affords other flowrates, thereby rendering the specific flow rate non-critical.) Thus, one of ordinary skill in the art would have optimized through routine experimentation the flowrate to maximally obtain the desired properties of filtration speed and 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).
Examiner further notes that the “flowrate” is drawn to a process recitation (flow). As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).
Response to Arguments
35 USC 112
Applicant’s amendments sufficiently overcome the rejection of Claim 11 under 35 USC 112(b) set forth by the previous office action. As such, the rejection of Claim 11 under 35 USC 112(b) is withdrawn.
35 USC 102/103
Applicant’s arguments are on the alleged grounds that Barnes does not teach the pump arrangement required by amended Claim 1, further noting that Barnes does not discuss the “breaking-apart” aspect of amended Claim 1.
Applicant’s arguments are not persuasive because the alleged deficiency in Barnes is cured through obvious combination with the prior art of Weilbacher, newly added herein as necessitated by Applicant’s amendments requiring the pump, which teaches a downstream pump from a blood aggregate filter alleviating clogging of the filter and allowing for multi-stage filtration for improved safety and efficacy of the filtration process. Further, while Barnes/Weilbacher does not specifically discuss the “breaking-apart” aspect of amended Claim 1, this recitation is drawn to a manner in which the claimed apparatus is used and the intended result that occurs during operation of the apparatus. A recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from the prior art apparatus of Barnes/Weilbacher having the same structure. Accordingly, the prior art of Barnes/Weilbacher commensurately teaching a filter/pump arrangement as claimed is commensurately capable of performing the recited breaking-apart functions when operated under suitable flow conditions.
Thus, Examiner sets forth the rejection of Claims 1-3, 5-8, and 23 (and dependents thereof) as unpatentable under 35 USC 103 over Barnes in view of at least Weilbacher, as discussed above in the body of the action and as necessitated by Applicant’s amendments.
New Claim 23
New Claim 23 is rejected under 35 USC 103 as unpatentable over Barnes in view of Weilbacher and Warkiani, and as merely providing a result effective variable which would have been obvious to one skilled in the art to optimize so as to achieve a desired filtration speed. Examiner further notes that para. [0034] of the instant specification affords other flowrates, thereby rendering the specific flow rate non-critical.
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 BENJAMIN JOSEPH KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden, can be reached at telephone number (703)756-5501. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798