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
Amendments filed 10/06/2025 have been entered. The amendments overcome the previous claim objections as well as the previous 35 U.S.C 112b rejection. As such the objection and 112b rejection have been withdrawn.
Response to Arguments
Applicant's arguments filed 10/06/25 have been fully considered but they are not persuasive.
The applicant argues that the claims are not directed to an apparatus or method of using an apparatus, where the apparatus provides the function of filtering out thrombi or metallic nanoparticles. Rather the claims are directed to a method of removing material from blood or blood products. The examiner respectfully disagrees. The claims are directed to a method of filtering, where said filtering (and sorbing) is done by a filter element. The examiner notes that the prior art references previous applied disclose a filtering device used in a method of treating blood, blood product, or physiologic fluid (per the abstract, previously cited, of Golobish). The examiner noted in the previous rejection that as the device of Golobish has the equivalent structure of the device performing the method (cross linked polymer filter element) and is configured to remove toxins, the device of Golobish would be capable of performing the same method as the instant application. However, in an effort to achieve compact prosecution, the examiner brought in both Nawani and Robinson to teach that methods for filtering metallic nanoparticles and thrombi using filters. As Golobish teaches filtering toxic materials and Nawani teaches that metallic nanoparticles (metals in aqueous solutions) are toxic, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use Golobish to remove metallic nanoparticles, a known toxin. Thus Golobish in view of Nawani, as previously provided reads to claimed rejection of metallic nanoparticles or thrombi. The examiner further rejected the claim in view of Robinson to show that filtering thrombi would also have been obvious to one having ordinary skill in the art. As Golobish teaches filtering undesirable materials and Robinson teaches that tissue fragments or a thrombus are undesirable and should be filtering out in blood systems, it would further have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use Golobish to remove tissue fragment or a thrombus, known undesirable materials in blood to be filtered out.
Regarding the argument that Zhao, as applied to claim 26, is mischaracterized as Zhao does not teach that the magnet surrounds the entire chamber to catch undesirable materials and rather catches enzymes is nonpersuasive. The examiner notes that as seen in figure 4, the dotted line referenced as the magnet is seen to surround the entire chamber. Additionally, the process of Zhao uses a “simple filtration and/or magnet capture” to separate components of the blood flowing through. Thus Zhao acts as a filter using both a filter and magnet to capture particles (see para. 0004 of Zhao). Further, in the context of Zhao (treating autoimmune disease by removing harmful antibodies from blood), the particles being filtered are undesirable (See Zhao para. 0005), where said antibodies being removed are “harmful”. Therefore as Golobish teaches methods of removing harmful or undesirable materials from blood, and Zhao teaches a system and operation of removing harmful antibodies from blood using both a filter and magnet structure, there is sufficient motivation to combine. As such the rejection of claim 26 in view of Zhao is being maintained by the examiner.
The examiner notes that as the claims have not been amended, and no terminal disclaimer has been filed, the double patenting rejection is upheld.
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.
Claim(s) 1-10,25,28-30,46-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golobish et al. US 2014/0294751, provided in the IDS hereafter Golobish, in view of Nawani et al. US 2018/0029010, hereafter Nawani, provided in the IDS, and further in view of Robinson et al. US 2003/0138349, hereafter Robinson.
Regarding claim 1, Golobish discloses
A method of filtering thrombi or metallic nanoparticles and undesirable particles or molecules from blood or blood products (abstract), said method comprising: filtering said blood or blood products containing said thrombi or metallic nanoparticles with a filter element comprising a cross-linked polymeric organic sorbent (para. 0008,0009) to remove the thrombi or metallic nanoparticles; and sorbing undesirable particles or molecules present in the blood or blood products into the cross-linked polymeric organic sorbent (para. 0008, 0016-0018). Per paragraphs 0008 and 0016-0018, the device teaches a filtration device (thus filters blood) comprising a sorbent, where blood for filtering contacts the sorbent, removing undesirable molecules from the blood (para. 0008). Per paragraph 0014, the undesirable materials include biologically active molecules, products of hemolysis, toxins, and more.
The examiner notes that while, Golobish discloses the same structure of a cross-linked polymeric organic sorbent for sorbing undesirable particles, where such particles include toxins, the device of Golobish would therefore be capable of adsorbing thrombi or metallic nanoparticles, as the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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.” The examiner notes that while claim 1 is directed to a method claim, the limitations reads to a method of using the apparatus, where the apparatus provides the function of filtering out thrombi or metallic nanoparticles.
However, should applicant disagree with this rejection, in an effort to achieve compact prosecution, the examiner provides Nawani.
Nawani teaches a method of removing metals from aqueous solutions (including blood per para. 0019), and is thus considered analogous to the claimed invention. Nawani further teaches that metal contaminants are known to be undesirable toxic containments in aqueous solutions (para. 0002), and that natural biomaterials used in an adsorbent are capable of adsorbing metals (abstract), where said biomaterials maybe blended with natural or synthetic polymers to give the adsorbent desirable mechanical properties. Therefore as Nawani teaches that metal contaminants are toxic and desired to be removed from aqueous solutions including blood, where this is done so by combining natural polymers and natural biomaterials, and Golobish teaches the removal of undesirable materials including toxins from blood, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to understand that metals are undesirable toxins within blood and modify the sorbent layer (comprising natural polymers) of Golobish to include biomaterials to aid in removing metals from the blood.
The examiner notes that while the combination of Golobish and Nawani read to claim 1, as the claim requires filtering thrombi or metallic nanoparticles. However, Golobish and Nawani fails to teach that a thrombus is being filtered. In an effort to achieve compact prosecution in view of the dependent claims, the examiner also brings in Robinson.
Robinson teaches a blood processing system and is thus considered analogous to the claimed invention. Per paragraph 0090, Robinson teaches that blood from a wound often contains substances that should not be introduced (undesirable materials), where such substances include particulates such as tissue fragments or a thrombus. Per the same citation, Robinson teaches that such particulates are commonly removed by blood filters. Therefore, as Robinson teaches that it is known in blood treatment devices that blood filters commonly remove undesirable material such as tissue fragments and thrombus, and Golobish teaches that materials filtered out include products of membrane/cell degradation, red cell particulates, similar molecules found in stored blood and blood products, and microvesicles, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the device of Golobish to remove a thrombus, as said device is a filter for removing undesirable material and thrombi, per Robinson, are commonly removed via filters in blood treatment.
Regarding claim 2, Golobish, Nawani, and Robinson teach
The method of claim 1, wherein said sorbent comprises cross-linked polymeric material derived from the reaction of a cross-linker with one or more of the following polymerizable monomers: divinyl-benzene, styrene, ethylstyrene, acrylonitrile, butyl methacrylate, octyl methacrylate, butyl acrylate, octyl acrylate, cetyl methacrylate, cetyl acrylate, ethyl methacrylate, ethyl acrylate, vinyltoluene, vinylnaphthalene, vinylbenzyl alcohol, vinylformamide, methyl methacrylate, and methyl acrylate (Golobish para. 0009, where monomers include all of the aforementioned monomers).
Regarding claim 3, Golobish, Nawani, and Robinson teach
The method of claim 1, wherein said solid forms comprise particles having a diameter in the range of from about 0.1 microns to about 200 microns (Golobish para. 0013,0017 diameter with a range of .1 micron to 2centimeters, and is thus within the claimed range); and are characterized as having a pore structure having a total volume of pore sizes in the range of from 10 A to 10,000 A is greater than 0.5 cc/g to 3.0 cc/g dry polymer (Golobish para. 0012); wherein the ratio of pore volume between 10 A to 3,000 A in diameter to pore volume between 500 A to 3,000 A in diameter of the said cross-linked polymeric material is smaller than 7:1 and wherein the ratio of pore volume between 10 A to 3,000 A in diameter to pore volume between 10 A to 6,000 A in diameter of said cross-linked polymeric material is less than 2:1 (Golobish para. 0012-0013).
Regarding claim 4, Golobish, Nawani, and Robinson teach
The method of claim 1, wherein said undesirable particles or molecules comprise one or more of the following: biologically active molecules (BAMs), biological response modifiers (BRMs), products of hemolysis, products of membrane or cellular degradation, toxins, drugs, antibodies, prions and similar molecules found in stored blood and blood products (Golobish para. 0014).
Regarding claim 5, Golobish, Nawani, and Robinson teach
The method of claim 4, wherein the biologically active molecules comprise (i) inflammatory mediators, (ii) stimulators, (iii) microthrombi, (iv) tissue or fatty matter released during a surgical or invasive procedure, or (v) any combination thereof (Golobish para. 0014).
Regarding claim 6, Golobish, Nawani, and Robinson teach
The method of claim 5, wherein said inflammatory mediators and stimulators comprise cytokines, nitric oxide, thromboxanes, leukotrienes, platelet,-activating factor, prostaglandins, glycoproteins, kinins, kininogens, complement factors, cell-adhesion molecules, superantigens, monokines, chemokines, interferons, free radicals, proteases, arachidonic acid metabolites, prostacyclins, beta endorphins, myocardial depressant factors, anandimide, 2-arachadonylglycerol, tetrahydrobiopterin, serotonin, histamine, bradykinin, soluble CD40 ligand, bioactive lipids, oxidized lipids, hemoglobin, red cell particulates, membrane or cellular components, growth factors, glycoproteins, prions, toxins, endotoxins, drugs, vasoactive substances, foreign antigens, microvesicles, antibodies, or any combination thereof (Golobish para. 0014).
Regarding claim 7, Golobish, Nawani, and Robinson teach
The method of claim 1 wherein the undesirable particles or molecules comprise antibodies (Golobish para. 0014).
Regarding claim 8, Golobish, Nawani, and Robinson teach
The method of claim 1. wherein the sorbent acts ex vivo (Golobish para. 0016).
Regarding claim 9, Golobish, Nawani, and Robinson teach
The method of claim 1, wherein the method is part of an extra corporeal treatment (Golobish para. 0016).
Regarding claim 10, Golobish, Nawani, and Robinson teach
The method of claim 1, wherein the thrombi is bacteria-induced thrombi or viral-induced thrombi. The examiner notes that per the rejection of claim 1, thrombi are a common material removed via filtering in blood treatment. The examiner notes that therefore, as the prior art teaches thrombi removal, where the source of the thrombi does not have an inherent effect on the structure or function or method of the device (as the device and method treats the final product that being a thrombus), it is interpreted that the device of the prior art would treat a thrombi of any origin, so long as it is in a blood treatment system.
Regarding claim 25, Golobish discloses
A blood purification device comprising:(a) a device for contacting said blood with thrombi or metallic nanoparticles (para. 0018, abstract); and(b) a filtration device for removing thrombi or metallic nanoparticles from said blood (para. 0008,0009), said filtration device comprising a sorbent, said sorbent comprising primarily a plurality of solid forms comprising particles having a diameter in the range of from about 0.1 microns to about 200 microns (para. 0013); said sorbent comprising a cross-linked polymer; said sorbent being capable of sorbing non-metallic undesirable molecules.(para. 0008, 0016-0018). Per paragraphs 0008 and 0016-0018, the device teaches a filtration device (thus filters blood) comprising a sorbent, where blood for filtering contacts the sorbent, removing undesirable molecules from the blood (para. 0008). Per paragraph 0014, the undesirable materials include biologically active molecules, products of hemolysis, toxins, and more.
The examiner notes that while, Golobish discloses the same structure of a cross-linked polymeric organic sorbent for sorbing undesirable particles, where such particles include toxins, the examiner notes that the device of Golobish would therefore be capable of adsorbing thrombi or metallic nanoparticles, as the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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.” The examiner notes that the limitations of claim 25 require a device with a filter comprising a sorbent, where the sorbent comprises particles with a diameter of .1-200 microns, all of which are met by the Golobish and as such it is interpreted that the device of Golobish would be capable of performing the function of filtering out thrombi or metallic nanoparticles. As per the rejection of claims 1 above as the device and method are read to by the prior art, and the applicant lacks evidence that the device performs unexpectedly for thrombi and metallic particles, as compared to other unwanted particulate, it is interpreted that the prior art device would perform the same function and thus reads to the claimed limitation.
However, should applicant disagree with this rejection, in an effort to achieve compact prosecution, the examiner provides Nawani.
Nawani teaches a method of removing metals from aqueous solutions (including blood per para. 0019), and is thus considered analogous to the claimed invention. Nawani further teaches that metal contaminants are known to be undesirable toxic containments in aqueous solutions (para. 0002), and that natural biomaterials used in an adsorbent are capable of adsorbing metals (abstract), where said biomaterials maybe blended with natural or synthetic polymers to give the adsorbent desirable mechanical properties. Therefore as Nawani teaches that metal contaminants are toxic and desired to be removed from aqueous solutions including blood, where this is done so by combining natural polymers and natural biomaterials, and Golobish teaches the removal of undesirable materials including toxins from blood, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to understand that metals are undesirable toxins within blood and modify the sorbent layer (comprising natural polymers) of Golobish to include biomaterials to aid in removing metals from the blood.
The examiner notes that while the combination of Golobish and Nawani read to claim 1, as the claim requires filtering thrombi or metallic nanoparticles. However, Golobish and Nawani fails to teach that a thrombus is being filtered. In an effort to achieve compact prosecution in view of the dependent claims, the examiner also brings in Robinson.
Robinson teaches a blood processing system and is thus considered analogous to the claimed invention. Per paragraph 0090, Robinson teaches that blood from a wound often contains substances that should not be introduced (undesirable materials), where such substances include particulates such as tissue fragments or a thrombus. Per the same citation, Robinson teaches that such particulates are commonly removed by blood filters. Therefore, as Robinson teaches that it is known in blood treatment devices that blood filters commonly remove undesirable material such as tissue fragments and thrombus, and Golobish teaches that materials filtered out include products of membrane/cell degradation, red cell particulates, similar molecules found in stored blood and blood products, and microvesicles, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the device of Golobish to remove a thrombus, as said device is a filter for removing undesirable material and thrombi, per Robinson, are commonly removed via filters in blood treatment.
Regarding claim 28, Golobish, Nawani, and Robinson teach
The blood purification device of claim 25, wherein said sorbent comprises cross-linked polymeric material derived from the reaction of a cross-linker with one or more of the following polymerizable monomers: divinyl-benzene, styrene, ethylstyrene, acrylonitrile, butyl methacrylate, octyl methacrylate, butyl acrylate, octyl acrylate, cetyl methacrylate, cetyl acrylate, ethyl methacrylate, ethyl acrylate, vinyltoluene, vinylnaphthalene, vinylbenzyl alcohol, vinylformamide, methyl methacrylate, and methyl acrylate. (Golobish para. 0009).
Regarding claim 29, Golobish, Nawani, and Robinson teach
The blood purification device of claim 25, wherein said solid form is characterized as having a pore structure having a total volume of pore sizes in the range of from 10 A to 10,000 A is greater than 0.5 cc/g to 3.0 cc/g dry polymer; wherein the ratio of pore volume between 10 A to 3,000 A in diameter to pore volume between 500 A to 3,000 A in diameter of the said cross-linked polymeric material is smaller than 7:1 and wherein the ratio of pore volume between 10 A to 3,000 A in diameter to pore volume between 10 A to 6,000 A in diameter of said cross-linked polymeric material is less than 2:1 (Golobish para. 0012-0013).
Regarding claim 30, Golobish, Nawani, and Robinson teach
The blood purification device of claim 25, wherein said filtration device comprises a cartridge containing said sorbent (Golobish para. 0018).
Regarding claim 46, Golobish discloses
A method of filtering thrombi or metallic nanoparticles from blood or blood products(para. 0018, abstract, para. 0008-0009), said method comprising: filtering said blood or blood products containing said thrombi or metallic nanoparticles with a filter element comprising a cross-linked polymeric organic sorbent to remove the thrombi or metallic nanoparticles (para. 0008,0009, 0016-0018).
The examiner notes that while, Golobish discloses the same structure of a cross-linked polymeric organic sorbent for sorbing undesirable particles, where such particles include toxins, the examiner notes that the device would therefore be capable of adsorbing thrombi or metallic nanoparticles, as the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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.” The examiner notes that while claim 46 is directed to a method claim, the limitations reads to a method of using the apparatus, where the apparatus provides the function of filtering out thrombi or metallic nanoparticles. As per the rejection of claims 46 above as the device and method are interpreted to be the read to by the prior art, and the applicant lacks evidence that the device performs unexpectedly for thrombi or metallic particles, as compared to other unwanted particulate, it is interpreted that the prior art device would perform the same function and thus reads to the claimed limitation.
However, should applicant disagree with this rejection, in an effort to achieve compact prosecution, the examiner provides Nawani.
Nawani teaches a method of removing metals from aqueous solutions (including blood per para. 0019), and is thus considered analogous to the claimed invention. Nawani further teaches that metal contaminants are known to be undesirable toxic containments in aqueous solutions (para. 0002), and that natural biomaterials used in an adsorbent are capable of adsorbing metals (abstract), where said biomaterials maybe blended with natural or synthetic polymers to give the adsorbent desirable mechanical properties. Therefore as Nawani teaches that metal contaminants are toxic and desired to be removed from aqueous solutions including blood, where this is done so by combining natural polymers and natural biomaterials, and Golobish teaches the removal of undesirable materials including toxins from blood, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to understand that metals are undesirable toxins within blood and modify the sorbent layer (comprising natural polymers) of Golobish to include biomaterials to aid in removing metals from the blood.
The examiner notes that while the combination of Golobish and Nawani read to claim 1, as the claim requires filtering thrombi or metallic nanoparticles. However, Golobish and Nawani fails to teach that a thrombus is being filtered. In an effort to achieve compact prosecution in view of the dependent claims, the examiner also brings in Robinson.
Robinson teaches a blood processing system and is thus considered analogous to the claimed invention. Per paragraph 0090, Robinson teaches that blood from a wound often contains substances that should not be introduced (undesirable materials), where such substances include particulates such as tissue fragments or a thrombus. Per the same citation, Robinson teaches that such particulates are commonly removed by blood filters. Therefore, as Robinson teaches that it is known in blood treatment devices that blood filters commonly remove undesirable material such as tissue fragments and thrombus, and Golobish teaches that materials filtered out include products of membrane/cell degradation, red cell particulates, similar molecules found in stored blood and blood products, and microvesicles, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the device of Golobish to remove a thrombus, as said device is a filter for removing undesirable material and thrombi, per Robinson, are commonly removed via filters in blood treatment.
Regarding claim 47, Golobish, Nawani, and Robinson teach
The method of claim 46, wherein said sorbent comprises cross-linked polymeric material derived from the reaction of a cross-linker with one or more of the following polymerizable monomers: divinyl-benzene, styrene, ethylstyrene, acrylonitrile, butyl methacrylate, octyl methacrylate, butyl acrylate, octyl acrylate, cetyl methacrylate, cetylacrylate, ethyl methacrylate, ethyl acrylate, vinyltoluene, vinylnaphthalene, vinylbenzyl alcohol, vinylformamide, methyl methacrylate, and methyl acrylate (Golobish para. 0009).
Regarding claim 48, Golobish, Nawani, and Robinson teach
The method of claim 46, wherein said sorbent comprises solid forms comprising particles having a diameter in the range of from about 0.1 microns to about 200 microns (Golobish para. 0013,0017 diameter with a range of .1 micron to 2centimeters, and is thus within the claimed range); and are characterized as having a pore structure having a total volume of pore sizes in the range of from 10 A to 10,000 A is greater than 0.5 cc/g to 3.0 cc/g dry polymer(Golobish para. 0012); wherein the ratio of pore volume between 10 A to 3,000 A in diameter to pore volume between 500 A to 3,000 A in diameter of the said cross-linked polymeric material is smaller than 7:1 and wherein the ratio of pore volume between 10 A to 3,000 A in diameter to pore volume between 10 A to 6,000 A in diameter of said cross-linked polymeric material is less than 2:1 (Golobish para. 0012-0013).
Regarding claim 49, Golobish, Nawani, and Robinson teach
The method of claim 46 wherein antibodies are attached to the metallic nanoparticles (Golobish para. 0014). The examiner notes that per para. 0014 of Golobish, antibodies are in the list of undesirable components capable of being removed. Further as per the rejection of claim 46 as metallic particles are also removed via the prior art device. Therefore, it is interpreted that, as both metallic particles and antibodies are capable of being removed via the device and method of Golobish, Nawani, and Robinson, absent persuasive evidence that the method is performed differently in view of antibodies specifically being located on metallic particles, that the prior art rejection would perform the same function and therefore reads to the claimed limitation.
As provided under the rejection of claim 46, per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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.” The examiner notes that while claim 49 is directed to a method claim, the limitations reads to a method of using the apparatus, where the apparatus provides the function of filtering antibody bound metallic particles. As per the rejection of claims 46 and 49 as the device and method are read to by the prior art, and the applicant lacks evidence that the device performs unexpectedly for antibody bound metals, it is interpreted that the prior art device would perform the same function and thus reads to the claimed limitation.
Regarding claim 50, Golobish, Nawani, and Robinson teach
The method of claim 46, wherein the sorbent acts ex vivo (para. 0016).
Regarding claim 51, Golobish, Nawani, and Robinson teach
The method of claim 46, wherein the method is part of an extra corporeal treatment (para. 0016).
Regarding claim 52, Golobish, Nawani, and Robinson teach
The method of claim 46, wherein the thrombi is viral-induced thrombi. The examiner notes that per the rejection of claim 46, Robinson teaches that thrombi are a common material removed via filtering in blood treatment. The examiner notes that therefore, as the prior art teaches thrombi removal, where the source of the thrombi does not have an inherent effect on the structure or function or method of the device (as the device and method treats the final product that being a thrombus), it is interpreted that the device of the prior art would treat a thrombi of any origin, so long as it is in a blood treatment system.
Regarding claim 53, Golobish, Nawani, and Robinson teach
The method of claim 46, wherein the thrombi is bacteria-induced thrombi. The examiner notes that per the rejection of claim 46, Robinson teaches that thrombi are a common material removed via filtering in blood treatment. The examiner notes that therefore, as the prior art teaches thrombi removal, where the source of the thrombi does not have an inherent effect on the structure or function or method of the device (as the device and method treats the final product that being a thrombus), it is interpreted that the device of the prior art would treat a thrombi of any origin, so long as it is in a blood treatment system.
Claim(s) 19-20,61-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over [Golobish in view of Nawani and Robinson and as further evidenced by Susanne Pfeiler, Steffen Massberg, Bernd Engelmann, Biological basis and pathological relevance of microvascular thrombosis, Thrombosis Research, Volume 133, Supplement 1, 2014, Pages S35-S37, ISSN 0049-3848, https://doi.org/10.1016/j.thromres.2014.03.016. (https://www.sciencedirect.com/science/article/pii/S0049384814001418), hereafter Pfeiler.
Regarding claim 19, Golobish, Nawani, and Robinson teach
The method of claim 1, however fails to specifically teach wherein the thrombi have a size in a range of from about 0.5 µm to about 5 µm; or from about 5 µm to about 10 µm; or from about 10 µm to about 15 µm; or from about 15 µm to about 20 µm; or from about 20 µm to about 25 µm; or from about 25 µm to about 30 µm; or from about 30 µm to about 35 µm; or from about 35 µm to about 40 µm; or from about 40 µm to about 45 µm; or from about 45 µm to about 50 µm; or from about 50 µm to about 55 µm; or from about 55 µm to about 60 µm; or from about 60 µm to about 65 µm; or from about 65 µm to about 70 µm; or from about 70 µm to about 75 µm; or from about 75 µm to about 80 µm; or from about 80 µm to about 85 µm; or from about 85 µm to about 90 µm; or from about 90 µm to about 95 µm; or from about 95 µm to about 100 µm.
The examiner relies on the Pfeiler reference to evidence that thrombi may be within the claimed range. Pfeiler teaches that thrombosis is known to frequently develop in microvessels, including arterioles, capillaries, and venules (page 2, para. 1). Pfeiler further teaches that microvessel thrombi are difficult to visualize due to their small size, which may be as small as less than 10µm (page 2, para. 2). Therefore Pfeiler evidences that blood systems may have thrombi formation of thrombi as small as less than 10µm. As it was found that the previous prior art combination (per rejection of claim 1) treats blood and is capable of filtering out thrombi or other particulates, and as evidenced by Pfeiler, thrombi may be as small as less than 10µm, it is interpreted that the deivce of Golobish, Nawani, and Robinson reads to the claimed invention.
Regarding claim 20, Golobish, Nawani, and Robinson teach
The method of claim 1, however fails to specifically teach wherein the thrombi have a size in a range of from about 0.5 µm to about 15 µm; or from about 0.75 µm to about 10 µm; or from about 1 µm to about 5 µm; or from about 1.5 µm to about 3 µm; or the thrombi has a size of 2 µm.
The examiner relies on the Pfeiler reference to evidence that thrombi may be within the claimed range. Pfeiler teaches that thrombosis is known to frequently develop in microvessels, including arterioles, capillaries, and venules (page 2, para. 1). Pfeiler further teaches that microvessel thrombi are difficult to visualize due to their small size, which may be as small as less than 10µm (page 2, para. 2). Therefore Pfeiler evidences that blood systems may have thrombi formation of thrombi as small as less than 10µm. As it was found that the previous prior art combination (per rejection of claim 1) treats blood and is capable of filtering out thrombi or other particulates, and as evidenced by Pfeiler, thrombi may be as small as less than 10µm, it is interpreted that the deivce of Golobish, Nawani, and Robinson reads to the claimed invention.
Regarding claim 61, Golobish, Nawani, and Robinson teach
The method of claim 46, however fails to specifically teach wherein the thrombi have a size in a range of from about 0.5 µm to about 5 µm; or from about 5 µm to about 10 µm; or from about 10 µm to about 15 µm; or from about 15 µm to about 20 µm; or from about 20 µm to about 25 µm; or from about 25 µm to about 30 µm; or from about 30 µm to about 35 µm; or from about 35 µm to about 40 µm; or from about 40 µm to about 45 µm; or from about 45 µm to about 50 µm; or from about 50 µm to about 55 µm; or from about 55 µm to about 60 µm; or from about 60 µm to about 65 µm; or from about 65 µm to about 70 µm; or from about 70 µm to about 75 µm; or from about 75 µm to about 80 µm; or from about 80 µm to about 85 µm; or from about 85 µm to about 90 µm; or from about 90 µm to about 95 µm; or from about 95 µm to about 100 µm.
The examiner relies on the Pfeiler reference to evidence that thrombi may be within the claimed range. Pfeiler teaches that thrombosis is known to frequently develop in microvessels, including arterioles, capillaries, and venules (page 2, para. 1). Pfeiler further teaches that microvessel thrombi are difficult to visualize due to their small size, which may be as small as less than 10µm (page 2, para. 2). Therefore Pfeiler evidences that blood systems may have thrombi formation of thrombi as small as less than 10µm. As it was found that the previous prior art combination (per rejection of claim 1) treats blood and is capable of filtering out thrombi or other particulates, and as evidenced by Pfeiler, thrombi may be as small as less than 10µm, it is interpreted that the deivce of Golobish, Nawani, and Robinson reads to the claimed invention.
Regarding claim 62, Golobish, Nawani, and Robinson teach
The method of claim 46, however fails to specifically teach wherein the thrombi have a size in a range of from about 0.5 µm to about 15 µm; or from about 0.75 µm to about 10 µm; or from about 1 µm to about 5 µm; or from about 1.5 µm to about 3 µm; or the thrombi has a size of 2 µm.
The examiner relies on the Pfeiler reference to evidence that thrombi may be within the claimed range. Pfeiler teaches that thrombosis is known to frequently develop in microvessels, including arterioles, capillaries, and venules (page 2, para. 1). Pfeiler further teaches that microvessel thrombi are difficult to visualize due to their small size, which may be as small as less than 10µm (page 2, para. 2). Therefore Pfeiler evidences that blood systems may have thrombi formation of thrombi as small as less than 10µm. As it was found that the previous prior art combination (per rejection of claim 1) treats blood and is capable of filtering out thrombi or other particulates, and as evidenced by Pfeiler, thrombi may be as small as less than 10µm, it is interpreted that the deivce of Golobish, Nawani, and Robinson reads to the claimed invention.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golobish in view of in view of Nawani and Robinson, and further in view of Zhao et al. US 2015/0290386, hereafter Zhao.
Regarding claim 26, Golobish, Nawani, and Robinson teach
The blood purification device of claim 25, but fails to specifically teach the device further comprising a magnetic collection component for removing a portion of said metallic nanoparticles from the blood, the magnetic collection component disposed within the blood purification device such that blood is first contacted with the magnetic collection component prior to said blood contacting the filtration device.
Zhao teaches a device for eliminating pathogenic antibodies (abstract), where blood is the medium being treated (para. 0003-0004), and is thus considered analogous to the claimed invention. Zhao teaches that one means of performing this function(seen in figure 4) is to provide a chamber with a filter membrane located within, and a magnet surrounding the entire chamber (see also claim 11, where the magnet catches undesirable materials and the filter is further used as a separation tool). Therefore, as Golobish teaches that the device may be used in a system where the system comprises a cartridge for containing the filtering sorbent (Golobish para. 0018), and it was found obvious that metallic particles would be an undesirable material capable of being removed (in view of Nawani) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a magnet around the filter chamber of Golobish, as taught by Zhao, as a means to capture metallic particles. The examiner notes that as seen in figure 4 of Zhao, the magnet completely surrounds the chamber, including at the entrance, whereas the filter is located at the exit. It is interpreted that material flowing through would first be affected by the magnet and then by the filter, and thus reads to the claimed limitation.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-9,25,28-30,46-51 rejected on the ground of nonstatutory double patenting as being unpatentable over claims1 and 4 of U.S. Patent No. US 11752250, hereafter 250. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1-6 and 46-48 of the instant application, claim 1 of 250 has all of the required limitations required of claims 1-6 and 46-48 in the instant application. Regarding claim 7, 49 of the instant application, claim 4 of 250 has the required limitation. Regarding claims 8-9 and 50-51 of the instant application, claim 1 of 250 requires that the sorbent may in a cartridge and/or storage bag and thus reads to the claimed limitation of being ex vivo and part of an extracorporeal treatment.
Regarding claims 25,28-30 of the instant application, see claim 1 of 250. Although claim 1 of 250 is a method claim, limitations within said claim also require a device. Claim 1 of 250 requires a cartridge comprising a sorbent where the sorbent filters out undesirable materials. The cartridge reads to “the device for contacting blood” and the sorbent reads to the “filtration device”. The rest of the claimed limitations of 25 and 28-30 are found in claim 1 of 250.
Instant Application Claim
US 11752250 Corresponding Claim
1
1
2
1
3
1
4
1
5
1
6
1
7
4
8
1
9
1
10
See obviousness type double patenting
19
See obviousness type double patenting
20
See obviousness type double patenting
25
1
26
n/a
28
1
29
1
30
1
46
1
47
1
48
1
49
4
50
1
51
1
52
See obviousness type double patenting
53
See obviousness type double patenting
61
See obviousness type double patenting
62
See obviousness type double patenting
Claim 10,52-53 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 11752250, hereafter 250 in view of Robinson.
Regarding claims 10,52,53, Patent 250 fails to teach a thrombus being treated.
Robinson teaches a blood processing system and is thus considered analogous to the claimed invention. Per paragraph 0090, Robinson teaches that blood from a wound often contains substances that should not be introduced (undesirable materials), where such substances include particulates such as tissue fragments or a thrombus. Per the same citation, Robinson teaches that such particulates are commonly removed by blood filters. Therefore, as Robinson teaches that it is known in blood treatment devices that blood filters commonly remove undesirable material such as tissue fragments and thrombus, and Patent 250 discloses a method of treating blood and removing undesirable materials, it would be obvious to use the device of 250 to also treat blood particles include tissue fragments of thrombi.
Claim 19-20,61-62 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 11752250, hereafter 250 in view of Robinson and as evidenced by Pfeiler.
Regarding claims 19-20,61-62, Patent 250 fails to teach a thrombus being treated where the thrombus is sized in the claim limitation.
Robinson teaches a blood processing system and is thus considered analogous to the claimed invention. Per paragraph 0090, Robinson teaches that blood from a wound often contains substances that should not be introduced (undesirable materials), where such substances include particulates such as tissue fragments or a thrombus. Per the same citation, Robinson teaches that such particulates are commonly removed by blood filters. Therefore, as Robinson teaches that it is known in blood treatment devices that blood filters commonly remove undesirable material such as tissue fragments and thrombus, and Patent 250 discloses a method of treating blood and removing undesirable materials, it would be obvious to use the device of 250 to also treat blood particles include tissue fragments of thrombi.
Pfeiler teaches that thrombosis is known to frequently develop in microvessels, including arterioles, capillaries, and venules (page 2, para. 1). Pfeiler further teaches that microvessel thrombi are difficult to visualize due to their small size, which may be as small as less than 10µm (page 2, para. 2). Therefore Pfeiler evidences that blood systems may have thrombi formation of thrombi as small as less than 10µm. As it was found that the previous prior art combination (per rejection of claim 1) treats blood and is capable of filtering out thrombi or other particulates, and as evidenced by Pfeiler, thrombi may be as small as less than 10µm, it is interpreted that the deivce of 250 and Robinson reads to the claimed invention.
Conclusion
THIS ACTION IS MADE FINAL. 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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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