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 .
Claims Status
Claims 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 22, and 23 are pending and are examined. Claim 17, 18, 19, 20, and 21 are withdrawn and are not examined. Claims 24 and 25 are cancelled.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Venumadhav (US Pub 2019/0369071; previously cited).
Regarding Claim 1, Venumadhav teaches a device for use in the separation of biological samples into a solid component and a liquid component (Figs 1A1-1C3 and [0058]), the device comprising:
a front cover (22) and a back cover (16+20) connected at a hinge portion (24) such that said device is operable between an open position (Fig. 1C-3) and a closed position (Fig. 1A-1);
a separation membrane (12) arranged to retain the solid component and to allow the liquid component to pass therethrough ([0057] cellulose fibers); and
an absorption membrane (14) arranged to retain the liquid component ([0057] cellulose fibers);
wherein said separation and absorption membranes are arranged in a layered structure between the front and back covers; and wherein opening the device from the closed position to the open position causes said separation and absorption membranes to bend thereby applying a compressive force to said membranes ([0057] When mechanically bent about an axis, paper strips essentially strain the cellulose fibers at the bent region. When paper strips featuring the bent section are exposed to water, water infiltration (through capillary action) through the fibrous network and the accompanying volume expansion of each individual fiber, particularly at the bent section, tends to actuate the bent paper flap back towards it natural (unbent) configuration. The flap rotates about the bent line towards the normal, unstrained position; the extent of actuation depends on the initial angle of the switch, the force applied for bending the paper, as well as the thickness and density of the paper material. By choosing the appropriate thickness, the actuating angle may be controlled such that the folded paper flap actuates to near horizontal configuration.).
Regarding Claim 2, Venumadhav teaches the device as claimed in claim 1, wherein the separation membrane comprises a first fixed end and a first free end, and the absorption membrane comprises a second fixed end and a second free end (switch 12 and base 16), wherein the first and second fixed ends are both fixed to the front cover or the back cover at, or close to, the hinge portion of the device, and the first and second free ends are fixed together and are free to move laterally with respect to the first and second fixed ends as the device moves between the open and closed positions (connection arm 20).
Regarding Claim 5, Venumadhav teaches the device as claimed in claim 1, wherein the device further comprises a straining portion ([0057] paper strips essentially strain the cellulose fibers at the bent region. through the bent section 24 of the switch).
Regarding Claim 6, Venumadhav teaches the device as claimed in claim 5, wherein the opening of the device causes the straining portion to apply the compressive force to said separation and absorption membranes ([0058] bent section. The bent section would be capable of applying a compressive force to the separation and absorption membranes).
Regarding Claim 7, Venumadhav teaches the device as claimed in claim 1, wherein the separation membrane is arranged above the absorption membrane switch 20 is above base 14).
Regarding Claim 8, Venumadhav teaches the device as claimed in claim 1, wherein the separation membrane and absorption membrane can be separately retrieved by punching out said membranes (the material of the membranes would be capable of being retrieved by separately punching out the membranes. This limitation is directed to intended use of the device).
Regarding Claim 9, Venumadhav teaches the device as claimed in claim 1, wherein the front cover and/or the back cover are made from a hole-punchable material (the material is made from a hold-punchable material. There is a broad range of materials that would be hole-punchable and paper and a membrane made of fibers would be capable of being hole-punchable.)
Regarding Claim 10, Venumadhav teaches the device as claimed in claim 1, wherein the biological sample is at least one of: blood, cerebrospinal fluid, urine, saliva, tear fluid, lymphatic fluid, tissue fluid, bronchi-alveolar lavage (BAL), and ascites ([0047] urine, [0002] including point of care detection of infectious diseases, hormones and metabolites in biological fluids, food borne pathogen detection and even in environmental monitoring.).
Regarding Claim 11, Venumadhav teaches the device as claimed in claim 1, wherein the separation of biological samples into a solid component and a liquid component occurs by capillary action ([0008] The methods and devices disclosed herein automate the performance of complex biological assays on paper based format. With the use of capillary pressure and capillary action).
Regarding Claim 12, Venumadhav teaches the device as claimed in claim 1, wherein the separation membrane comprises a filter paper that filters the liquid component of the biological sample, while capturing the solid components ([0058] The switch 12 is coupled to the base 14, the base 14 being comprised of filter paper or other similar material.).
Regarding Claim 13, Venumadhav teaches the device as claimed in claim 1, wherein the separation membrane layer comprises a single separation membrane or a plurality of separation membranes ([0057] cellulose fibers).
Regarding Claim 14, Venumadhav teaches the device as claimed in claim 1, wherein the absorption membrane comprises an absorptive paper that captures the liquid component of the biological sample ([0057] The basis of the present disclosure is a device that arises from the intrinsic properties of paper. Paper (e.g. wax paper) is essentially made of cellulose fibers that are hydrophilic and have a natural tendency to absorb moisture and as a consequence, undergo volume expansion.).
Regarding Claim 16, Venumadhav teaches the device as claimed in claim 1, wherein the solid component comprises a cellular component ([02057] The basis of the present disclosure is a device that arises from the intrinsic properties of paper. Paper (e.g. wax paper) is essentially made of cellulose fibers that are hydrophilic and have a natural tendency to absorb moisture and as a consequence, undergo volume expansion. When mechanically bent about an axis, paper strips essentially strain the cellulose fibers at the bent region.).
Claim Rejections - 35 USC § 103
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.
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Venumadhav (US Pub 2019/0369071; previously cited) as applied to claims 1 and 2, in view of Mehra (US Pub 2010/0233708; previously cited).
Regarding Claim 4, Venumadhav teaches the device as claimed in claim 2.
Venumadhav is silent to the separation membrane and absorption membrane are fixed by an elongate anchor that extends substantially across the width of the device.
Mehra teaches in the related art of a detection system. the detection system may further comprise one or more supporting blocks. [0045] The supporting blocks may be positioned between the first flow path and the second flow path. In one embodiment, the supporting blocks are positioned underneath the first flow path (e.g. top plane) and adjacent to the second flow path (e.g. bottom plane). Such supporting blocks can function to keep the top and bottom planes separated from each other and lend support to the structure of the detection system. In another embodiment, the detection system may further comprise a plastic backing that extends along the bottom surface of the second flow path (e.g. bottom plane).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an elongate anchor (plastic backing), as taught by Mehra, that extends substantially across the width of the device, as taught by Venumadhav, to allow for a supporting block for the entire device, as taught by Mehra, in [0045].
Regarding Claim 15, Venumadhav teaches the device as claimed in claim 1.
Venumadhav is silent to the separation membrane or plurality of separation membranes are impregnated with active agents.
Mehra teaches [0003] Such assays typically contain a binding partner for the analyte of interest coupled to a detectable label (i.e. labeled conjugates) and a porous membrane on which a capture protein (e.g. antibody or antigen) capable of binding the analyte of interest is immobilized. Labeled conjugates that are commonly used in these types of assays are antibodies or antigens coupled to gold nanoparticles or colored latex particles. [0009] In further embodiments of the invention, the conjugate region of the first flow path comprises a mobilizable conjugate complex including a first binding partner conjugated to a detectable entity.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added active agents (antibodies or antigens), as taught by Mehra, to the separation membrane in the device of Venumadhav, to allow for a binding partner to be capable of specifically binding to a target analyte, as taught by Mehra, in [0009].
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Venumadhav (US Pub 2019/0369071; previously cited), in view of Yoshimura (US Pub 2023/0176047; previously cited).
Regarding Claim 22, Venumadhav teaches a device for use in the separation of biological samples into a solid component and a liquid component (Figs 1A1-1C3 and [0058]), the device comprising: (i) a front cover (22) and a back cover (16+20) connected at a hinge portion (24) such that said device is operable between an open position and a closed position; (ii) a separation membrane (base 14) arranged to retain the solid component and to allow the liquid component to pass therethrough;
an absorption membrane (switch 12) arranged to retain the liquid component; and wherein said separation and absorption membranes are arranged in a layered structure between the front and back covers (see each layer);
Venumadhav is silent to (iv) a manually-operable actuation member; andwherein the manually-operable actuation member is arranged such that, when operated, the actuation member causes said separation and absorption membranes to bend thereby applying a compressive force to said membranes.
Yoshimura teaches in the related art of assay surfaces. ([0020] Additionally or alternatively, the magnetic element can be a magnet. Additionally or alternatively, the APU can include a sliding element, for example, a motor, configured to move the magnetic element under the control of the one or more processors along a horizontal direction of a plane defined by a top surface of the assay surface when received by the receiving component. Additionally or alternatively, the APU can include a drive element, for example, a motor or a string, configured to move the element).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an actuation member, as taught by Yoshimura, that can move the membranes in the device of Venumadhav, to allow for to urge at least one solid support disposed on the assay surface through at least one volume of liquid in at least one region of the sample processing component and to the detection component of the assay surface, as taught by Yoshimura in [0019].
Regarding Claim 23, modified Venumadhav teaches the device as claimed in claim 22, wherein the manually-operable actuation member comprises a pull cord, wherein pulling of the pull cord causes said separation and absorption membranes to bend thereby applying the compressive force to said membranes ([0020] Additionally or alternatively, the magnetic element can be a magnet. Additionally or alternatively, the APU can include a sliding element, for example, a motor, configured to move the magnetic element under the control of the one or more processors along a horizontal direction of a plane defined by a top surface of the assay surface when received by the receiving component. Additionally or alternatively, the APU can include a drive element, for example, a motor or a string, configured to move the element).
Response to Arguments
Applicant's arguments filed 5/6/26 have been fully considered but they are not persuasive.
First, Applicant argues on page 6 that the Venumadhav reference does not relate to a separation device as recited by claim 1, but rather a switch intended for integration into traditional paper-based microfluidic networks.
In response, the examiner notes Venumadhav teaches ([0057] The basis of the present disclosure is a device that arises from the intrinsic properties of paper. Paper (e.g. wax paper) is essentially made of cellulose fibers that are hydrophilic and have a natural tendency to absorb moisture and as a consequence, undergo volume expansion. When mechanically bent about an axis, paper strips essentially strain the cellulose fibers at the bent region. When paper strips featuring the bent section are exposed to water, water infiltration (through capillary action) through the fibrous network and the accompanying volume expansion of each individual fiber, particularly at the bent section, tends to actuate the bent paper flap back towards it natural (unbent) configuration. The flap rotates about the bent line towards the normal, unstrained position). The examiner notes that paper is known to be used to separate and identify a mixture including small molecules, amino acids, proteins, and antibodies. See [0002]. Since paper is a porous material, it can used for fluid flow and for separation.
The examiner further notes that while “solid” and “liquid” are in claim 1 regarding the “separation”, these components are not part of the claimed device since “solid” and “liquid” are not positively recited. So, separating a solid from a liquid is only an intended use of the device and not a required process step. Further, the claim is not precluded from having a switch since the switch would simply add additional control to the fluid flow through the porous paper. Therefore, the rejection is maintained.
Second, Applicant argues on bottom of page 6 and top of page 7 that the Venumadhav reference are not operable as a front cover and a back cover connected at a hinge portion such that said device is operable between an open position and a closed position.
In response, the examiner notes that the Venumadhav reference teaches a front cover 22 and a back cover (16+20) connected at hinge portion 24 ([0058] As shown in FIGS. 1A-1 to 1C-3, when a sample 30 is deposited on the first portion 16 of the base 14 that is connected to the connection arm 20 of the switch 12, the fluid extends through the first portion 16 to the connection arm 20, into the connection arm 20 of the switch 12, through the bent section 24 of the switch, and then into the flap section 22 of the switch 12. Figs. 1C-1-1C-3 shows the opening and closing of the device.) Therefore, the rejection is maintained.
Third, Applicant argues on page 10 that there is no motivation in the Venumadhav reference to link its inventive switch to anything but a traditional paper-based microfluidic network. There would be no advantage in providing the liquid control obtained by the Venumadhav reference to the claimed device.
In response, the examiner notes Venumadhav teaches ([0060] In short, such switches offer unique capabilities to fine-tuned control of fluid flow through microfluidic networks in paper. Examples include Figs. 1 and 1D); ([0058] As the flap section 22 moves to its initial unbent position, it then connects to or touches the second section 18 of the base 14, thereby fluidly connecting the first portion 16 and the second portion 18. Accordingly, such a device is a Timed ON device that permits timed control of introduction of fluid into the second section 18 of the base 14); ([0059] In various embodiments, FIG. 1D can illustrate a schematic of a switch mechanism that mimics an electrical analog of a transistor operation. In FIG. 1D fluid control is desired from two points such that sequential delivery of fluid may occur to the sink region (region C)). Thus, Venumadhav is considered to teach liquid control as an intended use of the device; and therefore, the rejection is maintained.
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 JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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