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 amendments filed on 09/25/2025 has been entered. Claim 1 has been amended; claim 2 has been cancelled. Accordingly, claims 1, and 3-20 are pending and under consideration.
Applicant’s amendments to the claims have overcome each and every objection previously set forth in the Non-final Office action mailed on 05/30/2025. Therefore, all claim objections are hereby withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on the same combination of reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicant’s remarks stating that “Gaitas does not disclose generating blood clots or using the blood clots themselves as the capturing medium” on page 6 of Applicant’s remarks, Examiner acknowledged the remarks. However, in the current rejections below necessitated by amendment, said limitations are taught by the secondary reference Ruoslahti. See rejection of claims below.
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, 3-7 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gaitas et al. US 2016/0334312 A1 (previously cited, hereinafter Gaitas) in view of Ruoslahti et al. US 2008/0305101 A1 (newly cited, hereinafter Ruoslahti).
Regarding claim 1, Gaitai discloses a method of removing harmful substances in blood (Abstract – “the invention relates to using binding materials to trap disease causing agent that is desired to be removed from the complex media such as the blood of a patient”, and Par. 53 – “trap disease causing agents that are desired to be concentrated (removed from sample) for further analysis”), which is performed by a fluidic device 103 (Fig. 1 – entrapment chamber 103) comprising:
an inlet (see annotated Fig. 1 below) into which isolated blood 101 (Fig. 1 – patient’s blood 101) is injected (Par. 55 – “a fluid sample (such as a patient's blood (101)) is moved by a pump (102) and flown through an entrapment chamber”); and
at least one clot generating and fixing unit 103 (Fig. 1),
the method comprising:
injecting isolated blood 101 (Fig. 1) into the inlet (Par. 55 – “FIG. 1, a fluid sample (such as a patient's blood (101)) is moved by a pump (102) and flown through an entrapment chamber… The chamber comprises an inlet, through which the fluid sample flows into the chamber”);
generating clots in blood injected into the inlet (Par. 55) and fixing the clots and fixing the generated clots in the at least one blood-clot generating and fixing unit 103 (Fig. 1, and Par. 53 – “using binding materials to trap disease causing agents that are desired to be concentrated (removed from sample)…”);
capturing harmful substances in blood by generating clots in the at least one clot generating and fixing unit 103 (Fig. 1) from the injected blood and fixing the clots (Par. 55 – “an entrapment chamber that has a binding material coated on its inner walls. The binding material captures a target material”, and Par. 53 – “using binding materials to trap disease causing agents that are desired to be concentrated (removed from sample) for further analysis”);
wherein, in the capturing of harmful substances in blood, the generated clots and the fixed clots capture the harmful substances (Par. 55 – “an entrapment chamber that has a binding material coated on its inner walls. The binding material captures a target material”) in the blood 101 (Fig. 1) being continuously injected (Par. 55 – “The chamber comprises an inlet, through which the fluid sample flows into the chamber… The flow is continuous”), and
the capturing of harmful substances in blood comprises allowing the blood 101 (Fig. 1) to pass through the at least one clot generating and fixing unit 103 (Fig. 1 and Par. 55 – “a fluid sample (such as a patient's blood (101)) is… flown through an entrapment chamber”), injecting substances that generate blood clots into the blood, or contacting a surface (Par. 55 – “a binding material coated”) on which the clots are generated with the blood 101 (Fig. 1, and Par. 55 – “a fluid sample (such as a patient's blood (101)) is moved by a pump (102) and flown through an entrapment chamber that has a binding material coated on its inner walls. The binding material captures a target material”).
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Annotated Fig. 1 of Gaitas
However, Gaitas does not disclose blood-clots, and wherein, in the capturing of harmful substances in blood, the generated blood clots in the at least one blood-clot generating and fixing unit capture pre-existent blood clots in the blood by fixing the blood clots in the blood being continuously injected.
Ruoslahti, in the same field of endeavor of clot binding compounds (Title), teaches blood-clot generation (Par. 7 – “The conjugate can cause clotting and amplify the accumulation of the conjugate in tumors. In one example, the conjugate can comprise a sufficient number and composition of clot binding compounds such that the conjugate causes clotting and amplifies the accumulation of the conjugate in tumors”); and wherein, in the capturing of harmful substances in blood (Par. 17 – “...The conjugate can selectively homes to tumor vasculature”), the generated blood clots (Par. 89 – “The surface molecules, alternatively referred to as a surface particles, disclosed herein can be conjugated with clot binding compounds in such a way that the conjugate is delivered to a clot, where it can accumulate and cause further clotting”) in the at least one blood-clot generating and fixing unit (Par. 93 – “Microspheres (or microbubbles) can also be used with the methods disclosed herein… in microfluidic channels”) capture pre-existent blood clots in the blood (Par. 89 – “the conjugate is delivered to a clot, where it can accumulate and cause further clotting”, and Par. 200 –“the present results show that the CREKA-modified nanoparticles not only bind to blood and plasma clots, but can also induce localized tumor clotting”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Gaitas to further include surface particles in the blood-clot generating and fixing unit that causes blood accumulation and clotting as taught by Ruoslahti, in order to cause a physical blockade of the harmful substances, in this instant case of Ruoslahti, tumor vessels and reduce tumor growth (Par. 203 of Ruoslahti). Furthermore, this induced clotting in tumors can also provide effective tumor imaging (Par. 202 of Ruoslahti) for further investigation.
Regarding claim 3, Gaitas in view of Ruoslahti suggest the invention of claim 1. However, Gaitas in view of Ruoslahti does not currently disclose wherein the substances that generate blood clots comprise at least one selected from the group consisting of glass, polymers, metals, calcium, von Willebrand factor, blood cells, plasma, platelets, blood clotting factors, prothrombin, collagen, thrombin, fibronectin, fibrinogen, fibrin, neutrophil extracellular traps (NETs), antibiotics, heparin, heparan sulfate, chitosan, sialic acid, hyaluronic acid, polyethylene imine (PEI), dextran sulfate, chondroitin sulfate, dermatan sulfate, glycosaminoglycan, mannose, montmorillonite, bentonite, nanoclay, ligands including urea bonds, thiourea bonds, amide bonds, peptide bonds, amino groups, amide groups, carboxyl groups, pyridyl groups, pyrimidyl groups, and imidazole groups, polymyxin B, and polyamino compounds.
Ruoslahti, in another embodiment, teaches wherein the substances that generate blood clots comprise at least one selected from the group consisting of plasma (Par. 44 – “The clot binding compound can be any compound with the ability to interact with clots and/or components of clots such as clotted plasma proteins”), antibiotics (Par. 110 – “an antibiotic”), amide bonds (Par. 57 – “A variety of peptidomimetics are known in the art including… educed amide bond”), peptide bonds (Par. 49-50 – “In one example, the clot binding compound can be a peptide or peptidomimetic”), amino groups (Par. 45 – “A plurality of the clot binding compounds can each be independently selected from, for example, an amino acid segment comprising the amino acid sequence REK”), amide groups (Par. 57), carboxyl groups (Par. 57), and imidazole groups (Par. 86).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Gaitas in view of Ruoslahti to have the substances that generate blood clots be substances as taught by Ruoslahti above, since these are materials that are known to target the vasculature of the tumor (Par. 42 of Rouslathi) and accumulate/induce additional clotting (Par. 43 of Ruoslahti).
Regarding claim 4, Gaitas in view of Ruoslahti suggest the invention of claim 1. Gaitas in view of Ruoslahti further discloses wherein the surface on which the blood clots are generated (Par. 12 of Gaitas – “binding materials may be pre-coated on the entrapment chamber or on parts of the chamber”) comprises polymers (Par. 14 of Gaitas – “the binding material is one or more binding materials selected from a group of binding materials comprising… polymers”).
Regarding claim 6, Gaitas in view of Ruoslahti suggest the invention of claim 1. Gaitas in view of Ruoslahti further discloses wherein at least a portion of the at least one blood-clot generating and fixing unit 103 (Fig. 1 of Gaitas) comprises the surface on which the blood clots are generated (Par. 12 of Gaitas – “binding materials may be pre-coated on the entrapment chamber or on parts of the chamber”), such that the generated blood clots are fixed to the at least one blood-clot generating and fixing unit 103 (Fig. 1 of Gaitas, and Par. 55 of Gaitas – “The binding material captures a target material”).
Regarding claim 7, Gaitas in view of Ruoslahti suggest the invention of claim 6. Gaitas in view of Ruoslahti further discloses wherein the surface on which the blood clots are generated (Par. 12 of Gaitas – “binding materials may be pre-coated on the entrapment chamber or on parts of the chamber”) comprises polymers (Par. 14 of Gaitas – “the binding material is one or more binding materials selected from a group of binding materials comprising… polymers”).
Regarding claim 9, Gaitas in view of Ruoslahti suggest the invention of claim 1. Gaitas in view of Ruoslahti further discloses wherein the blood clots comprise blood cells (Examiner contends that once the modification is made as discussed in claim 1, the method of Gaitas is capable of forming blood clot by Ruoslahti; and since the generated product are blood clots, they must comprise blood cells).
Regarding claim 10, Gaitas in view of Ruoslahti suggest the invention of claim 1. Gaitas in view of Ruoslahti further discloses wherein the harmful substances comprise at least one selected from the group consisting of infectious substances, cancers, cancer cells (Par. 55 of Gaitas – ”a disease causing agent such as a pathogen, cell, cancer cell, polymer, chemical compound, folic acid, pathogen reporter, or pathogen byproduct”, and Par. 7 of Ruoslahti – “tumor”).
Regarding claim 11, Gaitas in view of Ruoslahti suggest the invention of claim 1. Gaitas in view of Ruoslahti further discloses wherein the fluidic device 103 (Fig. 1 of Gaitas) further comprises an outlet (see annotated Fig. 1 of Gaitas above) to discharge the blood from the at least one blood-clot generating and fixing unit 103 (Fig. 1 of Gaitas, and Par. 55 of Gaitas – “The chamber comprises… an outlet, through which the fluid sample flows out of the chamber”).
Regarding claim 12, Gaitas in view of Ruoslahti suggest the invention of claim 1. Gaitas in view of Ruoslahti further discloses wherein the at least one blood-clot generating and fixing unit 103 (Fig. 1 of Gaitas) comprises microstructures 501 (from claim 12 above; Fig. 5 of Gaitas – pillars 501) protruding from an upper surface of the substrate (Fig. 5 of Gaitas – pillar 501 protruding downward from the upper surface of chamber 103)¸ or
particles 104 (Fig. 2b of Gaitas – spheres with antibodies 104) that are immobilized (Par. 56 of Gaitas – “the chamber (103) is a column partially or entirely backed with beads”) in the at least one blood-clot generating and fixing unit 103 (Fig. 1-2 of Gaitas) and capable of inducing shear stress of the blood (Examiner notes that the existing spheres/beads are highly inherent and capable of producing shear stress with the inflow of blood).
Regarding claim 13, Gaitas in view of Ruoslahti suggest the invention of claim 12. However, Gaitas in view of Ruoslahti does not currently disclose wherein a cross section of the microstructures is n-gonal or amorphous, and n is 3 to 12.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have configured the microstructures of Gaitas in view of Ruoslahti such that they are polygonal or amorphous, as it is a matter of engineering design to configure the cross-section of the microstructures in another shape, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Regarding claim 14, Gaitas in view of Ruoslahti suggest the invention of claim 12. However, Gaitas in view of Ruoslahti does not disclose wherein a height or interval of the microstructures is 10 μm to 10,000 μm.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the height of the microstructure to be in the range of 10 μm to 10,000 μm, in order to fit the particular procedure being done since this claimed dimension of the microstructure does not change the microstructure ability to form a binding with the harmful particles in blood. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Par. 45 of Applicant’s PG-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777
Regarding claim 15, Gaitas in view of Ruoslahti suggest the invention of claim 12. Gaitas in view of Ruoslahti further discloses wherein the fluidic device 103 (Fig. 1 of Gaitas) further comprises: a fluidic channel (see annotated Fig. 5 of Gaitas below – fluidic channel) arranged to correspond to the at least one blood-clot generating and fixing unit 103 (Fig. 5 of Gaitas) and through which the blood moves (Par. 59 – “the pillars are tightly positioned to increase the chances that the desired particles will collide with and stick to the pillars”, which indicates that blood has to flow through the in-between space), and
a height of the microstructures 501 (Fig. 5 of Gaitas) is equal to or less than a height of the fluidic channel (see annotated Fig. 5 of Gaitas below – the height of pillar 501 is also the height of the annotated fluidic channel).
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Annotated Fig. 5 of Gaitas
Regarding claim 16, Gaitas in view of Ruoslahti suggest the invention of claim 12. Gaitas in view of Ruoslahti further discloses wherein the particles 104 (Fig. 2 of Gaitas) are bead-shaped (Fig. 2b of Gaitas, and Par. 56 of Gaitas – “FIG. 2(b), the chamber (103) is a column partially or entirely backed with beads, for instance a glass bead column”).
Regarding claim 17, Gaitas in view of Ruoslahti suggest the invention of claim 1. However, Gaitas in view of Ruoslahti does not currently disclose wherein the fluidic device further comprises: fluidic channels arranged to respectively correspond to the inlet and the at least one blood- clot generating and fixing unit and through which the blood moves, and a cross-sectional area of a fluidic channel of the at least one blood-clot generating and fixing unit is smaller than a cross-sectional area of a fluidic channel of the inlet, or a height of the fluidic channel of the at least one blood-clot generating and fixing unit is smaller than a diameter of a cross section of the fluidic channel of the inlet, wherein as the blood flows from the inlet to the at least one blood-clot generating and fixing unit, stress shear of the blood is induced and blood clots are generated.
Gaitas, in an embodiment, teaches wherein the fluidic device 103 (Fig. 6) further comprises: fluidic channels (see annotated Fig. 6 below – fluidic channels) arranged to respectively correspond to the inlet (see annotated Fig. 6 below – inflowing blood traverses through the inlet via the left fluidic channel) and the at least one blood-clot generating and fixing unit 103 (Fig. 6 – fluidic channels in the middle section of the chamber 103) and through which the blood moves (Fig. 6), and
a cross-sectional area of a fluidic channel of the at least one blood-clot generating and fixing unit 103 is smaller than a cross-sectional area of a fluidic channel of the inlet (see annotated Fig. 6 below – the fluidic channels in the middle section have smaller cross-section than the left fluidic channel),
wherein as the blood flows from the inlet (see annotated Fig. 6 below) to the at least one blood-clot generating and fixing unit 103 (Fig. 6 – the arrows indicating blood flow), stress shear of the blood is induced (Examiner notes that the existing micro-tubes are highly inherent and capable of producing shear stress with the inflow of blood) and blood clots are generated (Fig. 6 – clot forming by targeted materials binding to binding material “Y”).
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Annotated Fig. 6 of Gaitas
It would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to have incorporated the fluidics channels as taught by Gaitas to the method of Gaitas in view of Ruoslahti, as Gaitas teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 18, Gaitas in view of Ruoslahti suggest the invention of claim 17. Gaitas in view of Ruoslahti further discloses wherein the at least one blood-clot generating and fixing unit 103 (Fig. 6 of Gaitas) comprises a structure in which the cross-sectional area of the fluidic channel is changed at least once (see annotated Fig. 6 of Gaitas above – the cross-section of the left fluidic channel is greater than that of the middle fluidic channel).
Examiner notes that once the modification is made as discussed in claim 17, the micro-tubes in Gaitas’s Fig. 6 embodiment will be incorporated into the method of Gaitas in view of Ruoslahti, including the fluidic channels with different cross-sections. Thus, the limitation is met.
Regarding claim 19, Gaitas in view of Ruoslahti suggest the invention of claim 1. However, Gaitas in view of Ruoslahti does not currently disclose wherein the at least one blood-clot generating and fixing unit comprises a plurality of layers or a plurality of tubes. Examiner notes that the current embodiment of Gaitas is of Fig. 2 where the chamber comprises spheres/beads.
Gaitas, in an embodiment, teaches wherein the at least one blood-clot generating and fixing unit 103 (Fig. 6) comprises a plurality of layers or a plurality of tubes (Par. 62 – “(arrangement shown at the bottom of FIG. 6) multiple micro-tubes are used. As previously, these micro-tubes are functionalized with binding material (such as capturing, binding, or killing) (602). The small size of the chamber increases the capturing probability, while the large number of the small size tubes in parallel increases the throughput”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Gaitas in view of Ruoslahti to incorporate the plurality of layers/tubes into the entrapment chamber, also as taught by Gaitas, as Gaitas teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gaitas in view of Ruoslahti as applied to claim 1 above, and further in view of Hosokawa US 8,372,342 B2 (previously cited, hereinafter Hosokawa).
Regarding claim 5, Gaitas in view of Ruoslahti suggest the invention of claim 1. However, Gaitas in view of Ruoslahti does not currently disclose wherein the at least one blood-clot generating and fixing unit generates the blood clots depending on shear stress of the blood according to a change in flow rate of the blood in which the flow rate of the blood increases or decreases as the blood passes through the at least one blood-clot generating and fixing unit.
Hosokawa, in the same field of endeavor of method of monitoring thrombus formation (Title), teaches wherein the at least one blood-clot generating and fixing unit 10 (Fig. 1 – thrombus formation chamber 10) generates the blood clots depending on shear stress of the blood (Par. 90 – “it is more preferable that a constriction portion may be formed on the channel in the thrombus formation chamber to provide the thrombus formation chamber with a shearing stress”) according to a change in flow rate of the blood in which the flow rate of the blood increases or decreases as the blood passes through (Par. 91 – “The thrombus formation chamber 10 at the coating portion may be preferably constricted and provided for a constriction portion 14, so high shearing stress-induced platelet aggregation can be monitored”) the at least one blood-clot generating and fixing unit 10 (Fig. 1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Gaitas in view of Ruoslahti, such that there is a constricted portion as taught by Hosokawa, as one of ordinary skill in the art would have recognized that the dimension through which blood flows is a result-effective variable, i.e., a variable which achieves a recognized result. In this case, the recognized result is that with a smaller dimension, i.e. a constricted portion in the entrapment chamber, the faster the blood flows, and the higher the shear stress. Therefore, since the general conditions of the claim, i.e. that a change in flow rate of the blood increases or decreases as the blood passes, which was produced by the change in dimension in the prior art by Hosokawa, it is not inventive to discover the optimum workable range by routine experimentation, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide blood-clot generation depending on shear stress and the change in blood flow rate as taught by Hosokawa. See MPEP 2144.05 II.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gaitas in view of Ruoslahti in view of Hosokawa as applied to claim 5 above, and further in view of Xu et al. US 2017/0252706 A1 (previously cited, hereinafter Xu).
Regarding claim 8, Gaitas in view of Ruoslahti in view of Hosokawa suggest the invention of claim 5. However, the combination does not disclose wherein the shear stress of the blood, capable of generating blood clots from the flowing blood is 1 dyne/cm2 to 10,000 dyne/cm2.
Xu, in the same field of endeavor of biological fluid separation device (Title), teaches wherein the shear stress of the blood is below 1500 dyne/cm2 (Par. 91).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shear stress of the blood of the combination to be below 1500 dyne/cm2 as taught by Xu, in order to provide cell entrapment (Par. 91 of Xu) and high-quality blood separation (Par. 8 of Xu).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the shear stress of the combination from below 1500 dyne/cm2 to between 1 and 10,000 dyne/cm2, as applicant appears to have placed no criticality on the claimed range (Par. 47 of Applicant’s PG-Pub) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Xu would not operate differently with the claimed range because the claimed range overlaps with the working range of Xu.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gaitas in view of Ruoslahti as applied to claim 17 above, and further in view of Belson US 2002/0091350 A1 (previously cited, hereinafter Belson).
Regarding claim 20, Gaitas in view of Ruoslahti suggest the invention of claim 17. However, Gaitas in view of Ruoslahti does not disclose wherein the fluidic device further comprises a blood clot filter capable of fixing blood clots to the at least one blood-clot generating and fixing unit or an outlet.
Belson, in the same field of endeavor of removing waste products in blood (Par. 4), teaches wherein the fluidic device 200 (Fig. 1 – dialyzer 200) further comprises a blood clot filter 308 (Fig. 1 – filter 308) capable of fixing blood clots to an outlet (Fig. 1 – “blood out”, and Par. 24 – “Thrombi and emboli… are prevented from entering the patient's circulatory system by a screen or filter 308 at the exit of the chamber 310”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Gaitas in view of Ruoslahti to further incorporate a blood clot filter at an outlet as taught by Belson, in order to prevent blood clots to enter the patient’s circulatory system (Par. 24 of Belson). One of ordinary skill in the art would have had the technological capability to recognize that clots entering or re-entering the circulation can have detrimental damage to a patient’s body as it inhibits blood flow to organs.
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
16 December 2025