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 .
Drawings
The drawings were received on 11/30/2023. These drawings are acceptable.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 54 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to claim 54 it is unclear if this limitation is intended to further limit the layer recited in claim 53, or if this limitation is intended to describe a new filter/sorbent that comprises two or more layers. For the purpose of examination, either interpretation taught by the prior art will suffice to read upon the claimed recitation. Clarification is requested.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 53, 57, 59-61, 65, 69 and 71 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al (US 2020/0376444 A1) (provided by applicant in IDS filed 7/8/2026).
With respect to claim 53 Liu discloses a device for separating a biological entity from a fluid sample, the device comprising:
a first sample chamber (collection chamber 14) comprising an inlet (inlet 70) (See Fig. 3 and Paras. 0038-0039);
at least one layer comprising a filter or sorbent (filter membrane 50) in fluid communication with the first sample chamber (See Fig. 3 and Para. 0039); and
a second sample chamber (collection container 60) in fluid communication with the layer (filter membrane is connected to the collection container 60 via a second connection tube 18), configured such that a sample transferred from the first sample chamber to the second sample chamber passes through the layer (See Para. 0039 and Fig. 3).
With respect to claim 57 Liu discloses that the layer comprises a porous material comprising bound material, wherein the bound material functions to separate the biological entity from the sample (See Paras. 0030-0033 for discussion of the incorporation of the attachment of one or more divalent ions to the filter membrane.
With respect to claim 59, applicant should note that these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Itoh and the apparatus of Itoh is capable of the recitation of claim 2. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Itoh (see MPEP §2114). It should further be noted that Liu does disclose that the virus or contaminant binds to the modified filter membrane when passed through the filtration system.
With respect to claim 60 Liu discloses that the biological entity comprises a biomolecule, a virus, a prion, a lipid, a saccharide, a biopolymer, or a combination thereof (See Para. 0022 for discussion of how the unprocessed or unpurified solution or material which comprises one or more biological material or molecules may be a virus).
With respect to claim 61 Liu discloses that the biomolecule comprises DNA, RNA, a protein, a lipid, a saccharide, a biopolymer, or a combination thereof (See Par. 0034 for discussion of how the virus may be a DNA and/or an RNA virus).
With respect to claim 65 Liu discloses that the porous material comprises cellulose, nitrocellulose, glass fiber, carbon, a metal oxide, or a combination thereof (See Paras. 0027-0028 for discussion of the filter membrane having porous surfaces which comprise cellulose, regenerate cellulose, and/or nitrocellulose based materials or compositions).
With respect to claim 69 Liu discloses that the inlet is in fluid communication with a fluid injection system (See Paras. 0039 and 0047 for discussion of how the filtration process through the filter membrane is driven by pressurized air or a peristaltic pump).
With respect to claim 71 Liu discloses that the fluid sample comprises a liquid (See Para. 0038 for discussion of the loading the filtration system with a crude load solution).
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) 54-56, 64, 67, 68, and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2020/0376444 A1) in view of Qian (US 2016/0097049 A1).
Refer above for the disclosure of Liu.
With respect to claim 54 Liu fails to disclose that the layer comprises two or more layers comprising filters or sorbents.
Qian teaches a system for collecting a sample of nucleic acid, wherein a filter column (200) contains a solid phase extraction matrix inside. The filter column has open ends (202) and (204) and an internal passage (206) there between containing a substrate (212) for collecting the nucleic acid. The filter column may also be referred to as a “hollow body” because it is designed for fluid to pass through it without the fluid being retained therein in the way that fluid is retained in a vessel or a receptacle. The filter column substrate may be adjacent a porous frit (214), and a retaining ring (210) may create a frictional engagement against the inside of the column to retain the substrate and frit in a position adjacent the neck of the filter column. The substrate may comprise a column binding matrix comprising a solid matrix which allows fluid to pass through the matrix. In certain aspects the matrix is highly porous so as to maximize surface area exposed to buffer solutions and thereby maximize the binding capacity of the matrix. A matrix can be made of various materials. In certain specific embodiments, the binding matrix may be a silica material (formed primarily of SiO2) such as glass fiber, silica beads, silica gel, sintered porous glass frit, etc. The porous frit may comprise inert plastic with a pore size 10-90μm. The solid extraction matrix (substrate) may comprise GF/D filter paper, such as made by punching the filter paper into disks that fit within the inside diameter of the column. Two or more layers of the filter disks may be put on top of the frit (See Paras. 0035-0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the filter/sorbent of Liu a multi-layer filter/sorbent, as taught by Qian, to ensure high quality filtration of the sample (See Paras. 0035-0037 of Qian).
With respect to claims 55 and 56 Liu fails to disclose that the second sample chamber comprises an outlet in fluid communication with a centrifugation tube or a spin column.
Qian teaches that the filter column (200) has open ends (202 and 204, interpreted as the inlet and outlet of the device) and an internal passage (206) therebetween containing a substrate (212) for collecting the nucleic acid (See Para. 0036). The entire column is positioned in a receptacle (centrifuge tube 400, See Para. 0076), and in an exemplary method, a syringe is interlocked with the receptacle cap, a syringe plunger is depressed to force a solution containing nucleic acid, in the presence of binding reagents such as chaotropic reagents and alcohol, to be passed through the filter column. The nucleic acid is thus retained on the filter (212), while the filtrate passes into the receptacle (See Para. 0039 and Figs. 2A-4; also see Para. 0089).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to facilitate the connection of the centrifuge tube (receptacle 400), as taught by Qian, to be connected to the outlet of Liu, such that the system can be contained (See para. 0039 of Qian)
With respect to claim 64 Liu fails to disclose that the porous material comprises any material with an oxide containing surface.
Qian teaches that the the binding matrix of the substrate 212 may comprise any support material known in the art, including materials selected from the group consisting of siliceous materials, silica gel, glass, Zeolite, aluminum oxide, titanium dioxide, Zirconium dioxide, kaolin, gelatinous silica, magnetic particles, a sintered porous glass frit, and ceramics or polymeric support materials. The nucleic acid-binding material may be any material to which nucleic acids bind (typically non-covalently) under certain conditions whereas other substances in a sample do not bind under these conditions. Nucleic acid binding is typically reversible such that the nucleic acids can be subsequently eluted again from the material by changing the conditions (See para. 0036).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate aluminum oxide into the porous material of Liu, as taught by Qian, such that under certain conditions, other, undesired substances in a sample do not bind to the porous material (See Para. 0036 of Qian).
With respect to claims 67 and 68 Qian fails to disclose the further incorporation of syringe, a collection tube, an air filtration system, or a fluidic system connected to an inlet and outlet of the device.
Qian teaches that the filter column (200) has open ends (202 and 204, interpreted as the inlet and outlet of the device) and an internal passage (206) therebetween containing a substrate (212) for collecting the nucleic acid (See Para. 0036). The entire column is positioned in a receptacle (400), and in an exemplary method, a syringe is interlocked with the receptacle cap, a syringe plunger is depressed to force a solution containing nucleic acid, in the presence of binding reagents such as chaotropic reagents and alcohol, to be passed through the filter column. The nucleic acid is thus retained on the filter (212), while the filtrate passes into the receptacle (See Para. 0039 and Figs. 2A-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to facilitate the connection of a syringe and a collection tube (receptacle 400), as taught by Qian, to be connected to the inlet and outlet of Liu, such that the system can be contained (See para. 0039 of Qian).
With respect to claim 70 the combination of Liu and Qian teaches that the outlet is in fluid communication with a collection tube, a centrifuge tube, a spin column, or any combination thereof (See rejection of claims 55 and 56 above).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2020/0376444 A1) in view of Cho et al WO 2022/075539 A1) (reference is made to related US 2023/0338011 A1).
Refer above for the disclosure of Liu.
With respect to claim 58 Liu fails to disclose the incorporation of nanoparticles bound to the bound material in the porous material.
Cho teaches a diagnostic kit, in which a detection device and a specimen collection tool are integrated, for diagnosing a target material (See Para. 0008). In the diagnostic kit, the detection strip of the device may include a sample pad absorbing a sample, a conjugation pad located under the sample pad and including a source material that reacts with a target material, and a membrane including a test line coated with the source material reacting with the target material and a control line coated with a source material used for a control group (See Para. 0019). In the diagnostic kit, the source material may be coupled with nano-sized nanoparticles and impregnated into the conjugation pad, and the nanoparticles may include one or more of gold particles, silver particles, latex, cellulose, and fluorescent particles (See Para. 0020).
It would have been obvious to one of ordinary skill in the art before ethe effective filing date of the claimed invention to incorporate the metal nanoparticles taught by Cho into the porous material of Liu for more precise capture of target specimen (See Para. 0008 of Cho).
Claim(s) 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2020/0376444 A1) in view of Wei et al (US 2017/0282155 A1).
Refer above for the disclosure of Liu.
With respect to claim 62 Liu fails to disclose that the biological entity can comprise a biomolecule such as a biopolymer, wherein the biopolymer comprises a polypeptide, an oligopeptide, a polysaccharide, an oligosaccharide, or a combination thereof.
Wei teaches superficially porous particles, device, kits and methods can be employed in a variety of diagnostic, analytical and research applications. The subject compositions and methods find use in any applications where the separation or purification of a variety of analytes in a sample is desirable. In some cases, the subject particles find use in the separation of a plurality of analytes from a sample via a chromatography method, where the subject particles are configured as the stationary phase (e.g., a particulate support) in a separation device. In general terms, the plurality of analytes can span a wide range of MWs, e.g., from lkDa to 500 kDa, such as from 1 kDa to 400 kDa, from 1 kDa to 300 kDa, or from 1 kDa to 200 kDa. In some cases, the method of separating includes contacting a sample comprising at least first and second analytes with the particulate support (e.g. as described herein) and eluting the analytes from the support thereby separating the at least first and second analytes. The first analyte can have a MW of 50 kDa or more, such as 75 kDa or more, 100 kDa or more, 200 kDa or more, etc., while the second analyte can have a MW of 20 kDa or less, such as 15 kDa or less, 10 kDa or less, 5 kDa or less, 4 kDa or less, 3 kDa or less, 2 kDa or less, 1 kDa or less, etc. Any convenient analytes can be separated, including but not limited to, an oligonucleotide, a peptide, a polypeptide, an antibody, and conjugates thereof (See Para. 0093).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Liu such that it is able to separate polypeptides, or any convenient analyte, as taught by Wei, such that the device can be employed n a variety of diagnostic, analytical, and research applications (See Para. 0093 of Wei).
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2020/0376444 A1) in view of Glavan et al (WO 2014/149645) (provided by applicant in IDS dated 7/8/2026).
Refer above for the disclosure of Liu.
With respect to claim 63 Liu fails to disclose that the bound material comprises or is derived from Tetraethyl orthosilicate, Triethoxy(octyl)silane, Triethoxyoctylsilane, Dodecyltriethoxysilane, n- Octadecyltriethoxysilane, Hexadecyltrimethoxysilane, Triethoxy(ethyl)silane, Isobutyltriethoxysilane, Triethoxymethylsilane, Trimethoxy(octadecyl)silane, (3- Aminopropyl)triethoxysilane, (3-Aminopropyl)trimethoxysilane, (3-Glycidyloxypropyl) trimethoxysilane, Tetraethyl orthosilicate, 3-(Trimethoxysilyl)propyl methacrylate, (3- Aminopropyl)trimethoxysilane, (3-Mercaptopropyl)trimethoxysilane, (3- Glycidyloxypropyl)trimethoxysilane, Trimethoxy(propyl)silane, Trimethoxy(3,3,3- trifluoropropyl)silane, 3-[2-(2-Aminoethylamino)ethylamino]propyl-trimethoxysilane, [3-(2- Aminoethylamino)propyl]trimethoxysilane, Trichlorosilane, 1H,1H,2H,2H- Perfluorooctyltriethoxysilane, 1H,1H,2H,2H-Perfluorodecyltriethoxysilane, (3- Glycidyloxypropyl)trimethoxysilane, (3-Glycidyloxypropyl)triethoxysilane, or combinations thereof
Glavan teaches the transformation of cellulose paper into an omniphobic material that is not wetted by water and organic liquids with surfaced tension as low as 28mN/m (See abstract). The cellulosic substrates can be covalently modified to provide an omniphobic surface using any suitable synthetic methodology (See Para. 0053). In one exemplary method, paper is transformed into an omniphobic material by exposure to vapors of a fluoridated or perfluorocarbon containing species, e.g., fluoroalkyl trichlorosilane, which react with the hydroxyl groups of the paper to form long fluoridated or perfluorocarbon chains of grafted siloxane molecules. It is simple (single step), rapid (~5 min to completion) and low-cost. The combined effects of the long fluoridated or perfluorocarbon chains of grafted siloxane molecules with the micro-scale roughness and porosity of paper (typical papers have a -30-45% void volume), yield an omniphobic material that preserves the properties of mechanical flexibility and low resistance to transport of gas of the untreated paper (See Para. 0042).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate trichlorosilane as the substance used to modify the cellulosic substrate of Liu, as taught by Glavan, to yield an omniphobic material that preserves the properties of mechanical flexibility and low resistance to transport of gas of the untreated paper (See Para. 0042 of Glavan).
Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2020/0376444 A1) in view of Grzelakowski (US 2017/0113193 A1).
Refer above for the disclosure of Liu.
With respect to claim 66 Liu fails to disclose that the porous material is functionalized with an amine terminated polymer.
Grzelakowski teaches a filtration membrane which comprises a porous support and, covalently bonded to a surface thereof, a layer comprising a plurality of vesicles having transmembrane proteins incorporated therein, said vesicles being formed from an amphiphilic block copolymer; characterized in that within said layer, vesicles are covalently linked together to form a coherent mass (See abstract). In one embodiment of the invention, the surface of the support may be functionalized in one or more steps to introduce specific reactive groups Z capable of reacting with complementary reactive groups X and/or Y. Suitable groups include amine groups (reactive with for example carboxylic acid or activated carboxylic acid groups X and/or Y) (See Para. 0029). In an especially preferred embodiment, the polymers used in the present invention have amine end groups (See Para. 0102). Vesicles having a desired size and low polydispersity can be obtained by known methods, for example by extrusion of large uni- and multi-lamellar polydisperse vesicles through one or more membranes of known pore size. Track etched polycarbonate membranes, for example Isopore (Trade Mark) membranes available from Millipore, are suitable for this purpose. Suitably, the vesicles used in the present invention have an average diameter in the range of from 30 to 10,000, preferably 50 to 1000, more preferably 100 to 400, especially from 150 to 250, nm (See para. 0106). Overall, the use of functional group terminated polymers, particularly amine-terminated polymers, together with a complementary multifunctional linking agent gives major advantages compared with known processes for the preparation of working filtration membranes (See Para. 0108).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the amine terminated polymer taught by Grzelakowski into the porous material of Liu to maximize the desirable attributes of the porous material, such more precise pore sizing (See Para. 0106 of Grzelakowski).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 July 29, 2026
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