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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/22/2026 has been entered.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b).
Applicant’s amendments fail to advance prosecution of the present application because: The amendment merely describes a desired behavior of prospective particles within a prospective sample liquid not positively required by the claim, and wherein the amendment merely adds further detail to such result-based behavior recitations to the particles which were previously rejected by the prior final rejection both as being fully satisfied by the commensurately structured prior art mesh of Barnes, as well as being drawn to a process recitation not holding particular patentable weight in a device claim where the device is capable of performing the recited process, and wherein the prior art mesh of Barnes is commensurately structured as claimed and thereby interpreted as being fully capable of achieving the desired collision-based particle dissociation as in the amended Claim 1.
As such, the Claim 1 amendment merely further describing a desired prospective process within a prospective sample fluid potentially achievable by the claimed apparatus fails to address the rejections of the previous action or further limit or distinguish the claims from the previous claim set, and this action is thereby made final.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed 0n 22 June 2026.
Claims 1-12 and 14-23 are pending.
Claim 13 is canceled.
Claims 12 and 14-22 are withdrawn.
No claims are newly added.
Claim 1 is amended.
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”, this being consistent with Applicant’s instant Fig. 3A showing the “spaces” 334A and 334B as openings/pores formed between the mesh wires 332.
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 aggregates of the particles are accelerated into contact with the mesh and are disassociated upon collision with structural members of the mesh into individual particles or smaller aggregates that pass through the spaces of the mesh, wherein 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 flowrate 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 flowrate 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 103
Applicant’s arguments are on the alleged grounds that Barnes is directed merely to size-exclusion filtration, rather than collision-induced dissociation, as Barnes describes the inner pre-filter as holding back aggregates greater than about 150 microns. Applicant thus asserts that Barnes neither discloses accelerating aggregates into the mesh with sufficient energy to cause breakup nor configuring the mesh such that aggregates strike structural members and dissociate as recited in the amended Claim 1.
Applicant’s arguments are not persuasive because Barnes expressly teaches that blood material smaller than 150 microns passes relatively unobstructed through the pre-filter 24 while only larger clots and aggregates are retained by the mesh of the pre-filter 24 (See Barnes col. 6, line 59 through col. 7, line 14; and Fig. 3.). Barnes therefore teaches actual flow of particle-containing liquid toward, into contact with, and through the mesh. This disclosure of Barnes likewise expressly recognizes that filter dimensions and aggregate dimensions govern passage and obstruction of the blood flow. Further, Barnes is modified in view of Weilbacher so as to provide a pump arrangement for driving the flow of fluid through the device and through the filter mesh as an obvious alternative achieving the same function of providing a flow as required by Barnes, and providing an active flow so as to alleviate clogging via a weak flow. The newly added language concerning the aggregates being “accelerated into contact with the mesh” and “disassociated upon collision” do not recite any additional pump component, impactor, specially shaped collision surface, controller, or any other relevant structure absent from Barnes/Weilbacher. Rather, such language merely characterizes what occurs when the claimed pump/mesh apparatus is operated at suitable flow conditions with the recited particles.
Further, the “particles in a liquid” are not a positively required element of the claim, merely being inferentially inferred as a configuration of the apparatus to receive such a prospective particle-having liquid solution, and the “flow” of blood through the apparatus is a process-type recitation not afforded particular patentable weight. As such, the particular process and behavior of such particles in the device are satisfied as long as the prior art is capable of such process – See MPEP 2114(II): “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)”. Thus, the specific manner of operating the claimed device with particularly sized prospective particles in a liquid solution not specifically required by the claim does not differentiate Claim 1 from the prior art of Barnes/Weilbacher teaching all the relevantly discussed structural elements of the filter mesh, housing, inlet, outlet, etc.
Applicant further argues on the alleged grounds that the amended Claim 1 limitation is not merely an intended result/process because it purportedly defines a specific structural-functional interaction among pump flowrate, particle dynamics, and mesh geometry whereby the pump supplies sufficient energy for aggregates to collide with mesh members and break into smaller aggregates or individual particles.
Applicant’s arguments are not persuasive because the Claim 1 amendment fails to identify a corresponding specific structural feature for achieving the process and result of the Claim 1 amendment which is absent from Barnes/Weilbacher. The claim broadly recites a pump coupled to the housing and defines the pump’s operation by the result obtained when particles contact the mesh. Applicant must provide the specific means for determining and setting such a pump pressure or specifically define the desired pressure range configuration of the pump. Functional language may limit an apparatus where it requires specific structure capable of the recited function; however, such language does not distinguish over corresponding prior art structure that possesses the same capability. Herein, the pump of Weilbacher is fully capable of providing flowrates capable of performing the claimed process, given that Weilbacher is commensurately drawn to pushing blood through a microaggregate filter, absent evidence to the contrary – see MPEP 2114(I).
Applicant further argues on the alleged grounds that there would have been no motivation to modify Barnes to achieve collision-based dissociation because Barnes and Weilbacher purportedly prevent clogging by filtration and retention, so one would have no reason to operate the pump at a flowrate sufficient to cause aggregate breakup recited in the amended Claim 1.
Applicant’s arguments are not persuasive because they improperly require the prior art to recognize or pursue Applicant’s instant purpose for providing the pump. See MPEP 2144(IV): “It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”. Herein, one of ordinary skill in the art would have found it obvious to provide the pump arrangement of Weilbacher to the filter mesh of Barnes 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. Barnes and Weilbacher address the same practical concern of maintaining effective blood flow through a filtration pathway in the presence of aggregates, and Weilbacher supplies the known mechanism of active pumping for doing so. The combination therefore constitutes a predictable use of a known pump for its established purpose in an analogous blood filtration system.
Further, once the pump is incorporated, selection of a suitable pump operating rate is a matter of ordinary optimization. MPEP 2114.05 explains that when the general conditions are taught, determining an optimum or workable range through routine experimentation is ordinarily obvious. Here, one of ordinary skill in the art would find it obvious to optimize the pump flowrate so as to appropriately increase/maximize the filtration throughput.
Applicant further argues on the alleged grounds that inherency requires the claimed aggregate-breakup feature to be necessarily present, rather than merely possible, and that Barnes and Weilbacher do not expressly disclose a flowrate that necessarily causes aggregates to break apart upon collision with the mesh as recited in the amended Claim 1.
Applicant’s arguments are not persuasive because Claim 1 is drawn to an apparatus claim in which the additional functional language such as included in the amendment herein merely describes operation of the already-recited pump/mesh structure. The prior art combination of Barnes/Weilbacher provides a corresponding housing, mesh, and downstream pump, while the disputed language specifies the manner in which the pump is operated and the resulting behavior of the intended particle-containing liquid. Such a manner of operation limitation does not distinguish the otherwise substantially identically structurally corresponding apparatus merely because Applicant has stated the operating result in greater detail.
Thus, in view of the discussions above, Examiner maintains the rejection of Claim 1 and dependents thereof as being unpatentable under 35 USC 103 over the prior art of Barnes in view of Weilbacher, as discussed above in the body of the action.
Applicant further argues on the alleged grounds that neither Brunner or Warkiani cures the alleged deficiencies in Barnes/Weilbacher discussed above. Applicant thereby contends the dependent Claims 4, 9-11 and 23 relying upon those references are allowable for the same reasons asserted with respect to Claim 1.
Applicant’s arguments are not persuasive because Brunner and Warkiani are not relied upon to supply the disputed aggregate-dissociation language of Claim 1. Thus, Examiner maintains the rejection of Claims 4, 9-11 and 23 as being unpatentable under 35 USC 103 over the prior art of Barnes in view of Weilbacher and Brunner (Claims 4 and 9-11) and/or Warkiani (Claim 23), as discussed above in the body of the action.
Regarding Applicant’s assertion that Brunner is drawn to screen printing rather than particle filtering from a flow, Brunner is merely relied upon to evidence how changing properties of a mesh results in changes in its retention properties. Brunner is not relied upon for specifically teaching any aspect of the claimed inventions, rather merely to support the conclusion that the variables of Claims 4, 9-11 and 23 are result-effective variables which, when modified, directly affect the retention properties of the mesh.
Applicant further argues on the alleged grounds that the mesh opening widths of Claim 4, mesh-member thickness of Claim 9, and mesh open-area percentages of Claim 10 are not result-effective variables because the claimed parameters purportedly concern Applicant’s mechanism of aggregate dissociation rather than conventional filter optimization.
Applicant’s arguments are not persuasive because the prior art need not recognize that a variable affects Applicant’s asserted result, but merely that the prior art recognizes the variable as affecting a property depending on the degree of the variable. Thus, it is sufficient that the art recognizes that the variable affects a relevant known property or result different from Applicant’s – see MPEP 2144.05(III)(C). Examiner further supplied the evidentiary reference of Brunner explaining that thread diameter and mesh opening together determine properties of the mesh and that mesh thickness, opening size, and open area follow from those basic mesh geometry parameters. Applicant’s argument effectively seeks to convert a known variable into a non-result-effective variable merely because Applicant has identified an additional benefit associated with a selected value, which is not sufficient to show one of ordinary skill in the art would not have found it obvious to optimize the variable. Further, Applicant has not provided evidence that the claimed ranges of 1.15-1.25 mm opening width (Claim 4), 0.127-0.381 mm member thickness (Claim 9), or 31-41% open area (Claim 10) arise from a criticality or produce an unexpected result different in kind from that typically expected by mere adjustment of mesh geometry.
Thus, Examiner maintains the rejection of Claims 4 and 9-10 as being unpatentable under 35 USC 103 over the prior art of Barnes in view of Weilbacher and Brunner, as discussed above in the body of the action.
Applicant further argues on the alleged grounds that the generated flowrate recited in Claim 23 is not a result-effective variable because neither Warkiani nor the other references teach selecting the flowrate for the purpose of collision-induced aggregate dissociation.
Applicant’s arguments are not persuasive because Warkiani expressly discloses a flowrate of 200 mL/min falling within the claimed range of 0.2-0.4 L/min, wherein Warkiani teaches the benefits of this flowrate as being suitable for filtering large amounts of blood (col. 5, lines 14-19). Thus, one skilled in the art would find it obvious to utilize this flowrate in Barnes/Weilbacher as a suitable flowrate for high-volume blood filtration. Further, flowrate was therefore recognized as affecting a result: the blood processing speed/throughput/time (higher flowrate = faster processing time) (lower flowrate = longer processing time); thus, the flowrate is indisputably a result-effective which would be obvious to optimize to one of ordinary skill in the art to maximize throughput while remaining within the pressure limitations of the system.
Additionally, Applicant has not provided a criticality and/or unexpected result associated with the claimed flowrate range; and Applicant’s own specification, as previously noted in the body of the rejection at paragraph [0034], additionally permits differing flowrates. This further weighs against any assertion that the specific claimed range represents a critical operating boundary.
Thus, Examiner maintains the rejection of Claim 23 as being unpatentable under 35 USC 103 over the prior art of Barnes in view of Weilbacher and Warkiani, as discussed above in the body of the action.
In conclusion, for the foregoing reasons discussed above, Applicant’s amendments and arguments filed 06/22/2026 are not found to overcome the rejection of Claims 1-11 and 23 under 35 USC 103. The amended recitation reciting an operational result does not patentably distinguish the structurally corresponding apparatus of the prior art. Applicant is suggested to provide the specific structure or configuration of the apparatus responsible for the recited desired dissociation result.
Examiner further notes that the mesh spaces in Barnes are 150 microns across. Red blood cells (erythrocytes) have an average diameter of 6.2-8.2 microns. Thus, aggregates about 20 cells-across may pass through the mesh and/or collide with the mesh before passing through or dissociated pieces thereof pass through. Given that such aggregates may be held together at least in part by extremely weak forces able to be overcome by miniscule forces, even a low-speed collision with one of the mesh fibers of Barnes would be expected to break apart such aggregates in operation.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 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, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center; and visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you need assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/B.J.K./Examiner, Art Unit 1798
/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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