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 .
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.
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 98-101 and 104-117 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mathies et al. (US 2006/0073484 A1), hereinafter “Mathies”.
Regarding Claim 98, Mathies teaches a multi-layer apparatus comprising:
(a) a first layer 105 (Fig. 1B and [0034]: “Typically, the pneumatic channels 107 and 109 are located on one wafer 105, herein referred to as the pneumatic wafer...”);
(b) a second layer 101 (Fig. 1B and [0034]: “...and the fluidic channels are etched on the second wafer 101, herein referred to as the fluidic wafer.”);
(c) a third layer 111 interposed between the first layer 105 and the second layer 101, the third layer 111 including an elastic membrane (Fig. 1B and [0033]: “an elastomer membrane 111 sandwiched between two glass wafers 101 and 105”);
(d) one or more fluidic channels 103/109 formed between the third layer 111 and one or both of the first or second layers 105/101 (Fig. 1B and [0034]: “A fluidic channel 103 is etched in the wafers prior to bonding and is used to carry fluids. A manifold channel 107 and a valve area 109 are similarly etched to carry air or other working fluid under pressure or vacuum to actuate the valves.”);
(e) a plurality of pressure ports positioned in the first layer and disposed adjacent to a periphery of the first layer (Figs. 2A and 2B, and [0037]: “various fluid control components within the monolithic membrane device are actuated by applying pressure or vacuum to holes on the pneumatic wafer”), each pressure port of the plurality of pressure ports including an opening extending completely through the first layer to the third layer (See Figs. 5A and 5B showing the pneumatic channel reservoir extending to the membrane 505 to actuate said membrane 505 as in Figs. 5C and 5D, the pneumatic channel reservoir having holes extending to the sides of the device. However, as discussed above, Mathies also teaches pneumatic access through the first layer, and wherein such side-on access also satisfies the “positioned in the first layer and disposed adjacent to a periphery of the first layer” provision, the holes merely being at the periphery and adjacent to and in/formed by the first layer.); and
(f) a plurality of fluid ports positioned in the first layer and disposed adjacent to the periphery of the first layer (See Fig. 12 and [0090]: “PCR buffer is introduced either through the original sample inlet 1211 or through a separate dedicated inlet” – Note Fig. 12 showing the sample inlet on the same side as the membrane valve openings (black dots). -- See also [0099] discussing the device fabricated with fluidic via holes. – Further note that side-entry such as shown in Fig. 3 further satisfies the “positioned in the first layer and disposed adjacent to the periphery of the first layer” limitation as the ports are formed in/formed by the first layer.), each fluid port of the plurality of fluid ports including an opening extending completely through the first layer to the third layer 111 (See Figs. 1B and 5B showing the fluidic channel and inlet thereof extending to the membrane layer 111, and further note that a principle of operation of the device is fluid contacting the membrane layer to be stopped or actuated around.),
the third layer 111 being configured to deform in response to pressurized fluid communicated to one or more of the plurality of pressure ports ([0038]: “Applying pneumatic pressure includes either applying pressure or applying a vacuum. The membrane 157 consequently can modulate the flow of fluid in the adjacent fluid channel as shown in FIG. 1D. In FIG. 1D...”. – See also Figs. 8 and 9 showing the membranes deforming to permit fluid flow of a sufficient pressure.), as in Claim 98.
Regarding Claim 99, the prior art meets the limitations of Claim 98 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the third layer including a plurality of pressure openings 201/203/205 (The portions of the membrane layer within the plural valve reservoirs such as seen through Figs. 2A and 2B acting as opening points for the membrane to be controllably actuated.), the opening of each pressure port of the plurality of pressure ports extending to a respective pressure opening of the plurality of pressure openings 201/203/205 (See Fig. 2A showing the pressure ports/openings as extending to the reservoir, thereby extending to the pressure opening formed by the reservoir.), as in Claim 99.
Regarding Claim 100, the prior art meets the limitations of Claim 98 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the third layer including a plurality of fluid openings (The portions of the membrane layer positioned adjacent to fluid opening/closing points, such as seen through Figs. 5D and 9.), the opening of each fluid port of the plurality of fluid ports extending to a respective fluid opening of the plurality of fluid openings (See Figs. 5B and 5C showing the fluidic port extending to the fluidic opening adjacent to the reservoir and controlled by the membrane.), as in Claim 100.
Regarding Claim 101, the prior art meets the limitations of Claim 98 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, each pressure port of the plurality of pressure ports being configured to be independently controlled to apply at least one of positive pressure or negative pressure to the third layer (See paras. [0037-0038] discussing applying pressure only to a single valve area, and Figs. 11-12 showing plural valve areas in a single device thereby being under independent control. – See also [0074]: “FIG. 9 is a diagrammatic representation showing open valves with the monoliths no longer sealed. According to various embodiments, pneumatic vacuum pressure is applied at regions 901, 903, 905, 907, and 909 to allow flow of an analyte along channel 921 through the frits 931, 933, 935, and 937.”), as in Claim 101.
Regarding Claim 104, the prior art meets the limitations of Claim 98 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the periphery of the first layer including: (i) a first edge, (ii) a second edge generally parallel to the first edge, (iii) a third edge generally perpendicular to the first and second edges, and (iv) a fourth edge generally parallel to the third edge (See Figs. 3-4 and 11-12 showing Applicant’s claimed square/rectangular configuration having the claimed parallel and perpendicular edges forming four interior 90 degree angles.), as in Claim 104.
Regarding Claim 105, the prior art meets the limitations of Claim 104 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the plurality of pressure ports being disposed adjacent to each of the first and second edges (See Fig. 4 showing the pressure ports/openings being adjacent to and formed in the first (top) and second (bottom) edges.), as in Claim 105.
Regarding Claim 106, the prior art meets the limitations of Claim 104 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the plurality of fluid ports being disposed adjacent to each of the first, second, third, and fourth edges (See Fig. 3 showing fluid ports extending to each edge of the card-shaped device, thus having ports arranged adjacent and between the first/second/third/fourth edges.), as in Claim 106.
Regarding Claim 107, the prior art meets the limitations of Claim 104 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the plurality of fluid ports being disposed adjacent to a mid-region of the first edge (See Fig. 3 where each of the fluid ports to the fluid channels is at a mid-region of each edge, ending at a middle point between the two corners forming the edge.), the plurality of pressure ports being disposed adjacent to the first edge in two groups such that the plurality of fluid ports is flanked by the two groups (See Fig. 3 showing the pneumatic channels (dashed lines) flanking each of the first/second/third/forth channels and their ports at the middle edges of the device, each port having a pneumatic channel and a pneumatic port on either side.), as in Claim 107.
Regarding Claim 108, the prior art meets the limitations of Claim 104 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the plurality of pressure ports being arranged in a pair of rows disposed adjacent to the first edge (See Fig. 3 showing the pressure ports arranged in rows along the first (bottom) edge, and the other ports also remaining to satisfy the “adjacent” condition, those ports being nearby the first edge, the ports being arranged in respective rows along or between the edges. – See also Fig. 12 where the ports (black dots) are each arranged in a respective side-by-side row near the edges of the device.), as in Claim 108.
Regarding Claim 109, the prior art meets the limitations of Claim 104 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the plurality of fluid ports being arranged in a pair of rows disposed adjacent to the first edge (See Fig. 3 showing the fluid ports formed as a pair of perpendicular, intersecting rows arranged adjacent/nearby the first (bottom) edge.), as in Claim 109.
Regarding Claim 110, the prior art meets the limitations of Claim 104 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the periphery of the first layer being generally square-shaped (See Fig. 3 showing the fluid router component discussed above as being generally square-shaped.), as in Claim 110.
Regarding Claim 111, the prior art meets the limitations of Claim 98 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the first layer comprising a first plate, the second layer comprising a second plate ([0033]: “two glass wafers 101 and 105” – Therein, the glass wafers are interpreted as being plates given that glass wafers are flat and rigid.), as in Claim 111.
Regarding Claim 112, the prior art meets the limitations of Claim 98 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, one or both of the first layer or the second layer comprising a material that is at least substantially translucent to visible or ultraviolet light ([0033]: “two glass wafers 101 and 105” – Therein, glass is substantially translucent to visible and ultraviolet light. – See also [0097].), as in Claim 112.
Regarding Claim 112, the prior art meets the limitations of Claim 98 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, one or both of the first layer or the second layer comprising a transparent material ([0033]: “two glass wafers 101 and 105” – Therein, glass is a substantially transparent material.), as in Claim 112.
Regarding Claim 113, the prior art meets the limitations of Claim 98 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, one or both of the first layer or the second layer including a rigid material ([0033]: “two glass wafers 101 and 105” – Therein, glass is a substantially rigid material.), as in Claim 113.
Regarding Claim 115, Mathies teaches a multi-layer apparatus comprising:
(a) a first layer 105 having a transparent central region (Fig. 1B and [0034]: “Typically, the pneumatic channels 107 and 109 are located on one wafer 105, herein referred to as the pneumatic wafer...” [0033]: “two glass wafers 101 and 105” – Therein, glass is a substantially transparent material. As the entire first layer is made of glass, the first layer thereby has a transparent central region.);
(b) a second layer 101 (Fig. 1B and [0034]: “...and the fluidic channels are etched on the second wafer 101, herein referred to as the fluidic wafer.”);
(c) a third layer 111 interposed between the first layer 105 and the second layer 101, the third layer 111 including an elastic membrane (Fig. 1B and [0033]: “an elastomer membrane 111 sandwiched between two glass wafers 101 and 105”);
(d) a plurality of pressure ports positioned in the first layer (Figs. 2A and 2B, and [0037]: “various fluid control components within the monolithic membrane device are actuated by applying pressure or vacuum to holes on the pneumatic wafer”), each pressure port of the plurality of pressure ports including an opening extending completely through the first layer to the third layer (See Figs. 5A and 5B showing the pneumatic channel reservoir extending to the membrane 505 to actuate said membrane 505 as in Figs. 5C and 5D, the pneumatic channel reservoir having holes extending to the sides of the device. However, as discussed above, Mathies also teaches pneumatic access through the first layer, and wherein such side-on access also satisfies the “positioned in the first layer and disposed adjacent to a periphery of the first layer” provision, the holes merely being at the periphery and adjacent to and in/formed by the first layer.); and
(e) a plurality of fluid ports positioned in the first layer 105 (See Fig. 12 and [0090]: “PCR buffer is introduced either through the original sample inlet 1211 or through a separate dedicated inlet” – Note Fig. 12 showing the sample inlet on the same side as the membrane valve openings (black dots). -- See also [0099] discussing the device fabricated with fluidic via holes. – Further note that side-entry such as shown in Fig. 3 further satisfies the “positioned in the first layer and disposed adjacent to the periphery of the first layer” limitation as the ports are formed in/formed by the first layer.), each fluid port of the plurality of fluid ports including an opening extending completely through the first layer 105 to the third layer 111 (See Figs. 1B and 5B showing the fluidic channel and inlet thereof extending to the membrane layer 111, and further note that a principle of operation of the device is fluid contacting the membrane layer to be stopped or actuated around.),
the plurality of pressure ports and the plurality of fluid ports being arranged about the transparent central region of the first layer such that the transparent central region is exposed for visualization (See Fig. 3 showing the fluid ports and pressure ports being arranged about a periphery of the fitment, thereby leaving he transparent glass central region exposed.), as in Claim 115.
Regarding Claim 116, Mathies teaches a multi-layer apparatus comprising:
(a) a first layer 105, at least a portion of the first layer being transparent (Fig. 1B and [0034]: “Typically, the pneumatic channels 107 and 109 are located on one wafer 105, herein referred to as the pneumatic wafer...” [0033]: “two glass wafers 101 and 105” – Therein, glass is a substantially transparent material.);
(b) a second layer 101 (Fig. 1B and [0034]: “...and the fluidic channels are etched on the second wafer 101, herein referred to as the fluidic wafer.”);
(c) a third layer 111 interposed between the first layer 105 and the second layer 101, the third layer 111 including an elastic membrane (Fig. 1B and [0033]: “an elastomer membrane 111 sandwiched between two glass wafers 101 and 105”);
(d) a plurality of pressure ports positioned in the first layer 105 and disposed adjacent to an edge of the first layer 105 (Figs. 2A and 2B, and [0037]: “various fluid control components within the monolithic membrane device are actuated by applying pressure or vacuum to holes on the pneumatic wafer” – See also Fig. 3 showing the pressure ports disposed adjacent/nearby the first (bottom) edge.), each pressure port of the plurality of pressure ports including an opening extending completely through the first layer 105 to the third layer 111 (See Figs. 5A and 5B showing the pneumatic channel reservoir extending to the membrane 505 to actuate said membrane 505 as in Figs. 5C and 5D, the pneumatic channel reservoir having holes extending to the sides of the device. However, as discussed above, Mathies also teaches pneumatic access through the first layer, and wherein such side-on access also satisfies the “positioned in the first layer and disposed adjacent to a periphery of the first layer” provision, the holes merely being at the periphery and adjacent to and in/formed by the first layer.); and
(e) a plurality of fluid ports positioned in the first layer 105 and disposed adjacent to the edge of the first layer 105 (See Fig. 12 and [0090]: “PCR buffer is introduced either through the original sample inlet 1211 or through a separate dedicated inlet” – Note Fig. 12 showing the sample inlet on the same side as the membrane valve openings (black dots). -- See also [0099] discussing the device fabricated with fluidic via holes. – Further note that side-entry such as shown in Fig. 3 further satisfies the “positioned in the first layer and disposed adjacent to the periphery of the first layer” limitation as the ports are formed in/formed by the first layer. – See also Fig. 3 showing the fluid ports disposed adjacent/nearby the first (bottom) edge.), each fluid port of the plurality of fluid ports including an opening extending completely through the first layer 105 to the third layer 111 (See Figs. 1B and 5B showing the fluidic channel and inlet thereof extending to the membrane layer 111, and further note that a principle of operation of the device is fluid contacting the membrane layer to be stopped or actuated around.), as in Claim 116.
Regarding Claim 117, the prior art meets the limitations of Claim 116 as discussed above. Further, Mathies teaches the multi-layer apparatus discussed above, the plurality of fluid ports being disposed adjacent to a mid-region of the edge (See Fig. 3 showing each fluidic port extending to a mid-region of each edge, approximately halfway between each corner pair forming each edge.), the plurality of pressure ports including a first group disposed on a first side of the plurality of fluid ports and a second group disposed on a second side of the plurality of fluid ports (See Fig. 3 showing the plurality of pressure ports forming groups about the plurality of fluid ports, each fluid port being flanked by plural pressure ports.), as in Claim 117.
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 102 and 103 are rejected under 35 U.S.C. 103 as being unpatentable over Mathies in view of Visone et al. (R. Visone, G. S. Ugolini, V. Vinarsky, M. Penati, A. Redaelli, G. Forte, M. Rasponi, Adv. Mater. Technol.; 21 September 2018, 4, 1800319.), hereinafter “Visone”. Mathies has been discussed above.
Regarding Claims 102 and 103, Mathies does not specifically teach the multi-layer apparatus, the opening of each pressure port of the plurality of pressure ports having a first diameter, the opening of each fluid port of the plurality of fluid ports having a second diameter different from the first diameter, nor the first diameter being less than the second diameter, as in Claims 102 and 103 respectively.
However, Visone teaches a respective layered microfluidic device (See paragraph 1 of the “experimental section”.) wherein fluid is actuated into the device via fluidic ports 3-4 mm in diameter, while the device further comprises pneumatic ports only 0.5 mm in diameter (See paragraph 2 of the “experimental section”.), the pneumatic ports thereby being smaller in diameter than the fluidic ports. Therein, one of ordinary skill in the art would have recognized this size relationship as being optimized for the respective port functions of actuating gas and fluid, fluid requiring a larger port to reduce flow resistance, while gas flowing through the pneumatic port experiences less drops in resistance, the gas merely being pressurized across the port, and thereby saving surface area space of the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the multi-layer apparatus of Mathies, the opening of each pressure port of the plurality of pressure ports having a first diameter, the opening of each fluid port of the plurality of fluid ports having a second diameter different from the first diameter, and the first diameter being less than the second diameter, such as suggested by Visone, as ordinary skill in the art would have recognized this size relationship as being optimized for the respective port functions of actuating gas and fluid, fluid requiring a larger port to reduce flow resistance, while gas flowing through the pneumatic port experiences less drops in resistance, the gas merely being pressurized across the port, and thereby saving surface area space of the device.
Claims 98, 105-114, and 116-117 are rejected under 35 U.S.C. 103 as being unpatentable over Mathies. Mathies has been discussed above.
Claims 98, 105-114, and 116-117 require various particular locational placement of the plurality of pressure ports and the plurality of fluid ports, such as their disposition near/adjacent to edges and/or layers/periphery of the device. Therein, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C).
Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of ports would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the ports.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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