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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 20, 2025 has been entered.
Response to Arguments
Applicant’s arguments, see amendments/remarks, filed December 30, 2024, with respect to the rejection(s) of claim(s) 73-91 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Maerkl et al., US 20040112442 A1.
It is noted that applicant has not indicated how the drawing objection has been addressed.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, , a membrane that comprises at least two polymeric layers and more than two polymeric layers (claim 74) (it is unclear what structure(s) presented in the figures is are intended to correspond to the membrane and at least two layers of such), a plurality of valves coupled to said fluidic channel (claim 83, a plurality of valves is not shown), and a plurality of fluidic channels (claim 88) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. It is noted that the drawings illustrate a valve comprising a fluidic channel not a fluidic channel coupled to a plurality valves as recited in claim 83.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
Although the device claims mention a support, positive or negative pressure, fluid, a different pneumatic channel(s), a structurally undefined computer system, and a structurally undefined computer network, none are positively claimed as structural elements of the claimed device. All of the prior are materials and/or articles intended to be or can be worked upon or used with the device. None of the prior further structurally limit the claimed device.
It is noted that the terms “at least two” and “plurality” only requires two, but allows for the presences of more than two. However, there is no illustration nor description of more than two polymeric layer and a plurality of fluidic channels as recited in the claims.
It is noted that the “pneumatic layer” and “fluidic layer” are not defined by any specific structures. The “configured to…” clauses are directed to intended possible use.
It is noted that the terms “actuate” and “actuation” are broad, vague, ambiguous, and does not require any movement of the pneumatic and fluidic layers, it appears that only the membrane is required to be structural capable of moving/deflecting “towards or “away” to/from…relative to the fluidic layer. It is noted that the term “or” is directed to alternatives not requirements and are respectively conditional upon the application of positive “or” negative pressure to the membrane.
As to claim 74, it is noted that there no structural connectivity provided for in the claim for the at least two polymeric layers relative to each other nor any other prior positively claimed element. The at least two polymer layers are not claimed as being structurally connected nor in any structural contact with each other. For example, such as a first polymeric layer being stacked on a second polymeric layer such that a bottom surface of the first polymeric layer is contact with an upper surface of second layer (or any other structural nexus, such as the layers being arranged horizontally and having surfaces in contact).
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.
Claims 78, 83, and 88 are 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.
The term “about” in claim 78 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication as what variances for the recited values, values other than 1 micron and 1000 microns is considered as “about” 1 micron and about 1000 microns. What values that may be considered as about 1 micron and about 1000 microns to one person may not be considered as such to another and vice versa.
As to claim 83, it is unclear how a fluidic channel is coupled to a plurality of valves and what channel described in the specification and shown in the drawings is considered as such fluidic channel, because the claims are inconsistent with the specification and drawings because the specification and drawing describe and illustrate the fluidic channel 105, 207 as being an element of the fluidic layer 103, 205 of the valve 100, 200. The fluidic channel is an element of the valve and not coupled to the valve(s) as claimed. See paragraphs 0054, 69, and the figures of the publication. However, claim 83 does not provide for such. The claim does not require the fluidic channel to be an element of the fluidic layer.
As to claim 88, it is what is the structural nexus provided for between the “a plurality of fluidic channels” of claim 88 and “a fluidic channel” of claim 73 because it is unclear whether or not the a fluidic channel of claim 1 is or is amongst, included with the plurality of fluidic channels or different from such plurality of fluidic channels. As presently drafted the a fluidic channel of claim 73 is not required to be within the plurality of fluidic channels of claim 88 and the plurality of fluidic channels of claim 88 are not required to each be comprised within a valve.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 73-75, 77-83, 88, and 90-91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korbin et al., US 2011/0126911 in view of Maerkl et al., US 20040112442 A1.
As to claims 73 and 91, Kobrin discloses a microfluidic device and method of use (abstract: para [0080], [0072], [0040]: figures 5 and 23. This invention provides composite plastic articles and methods of making them. The articles can be fluidic or microfluidic devices having fluidic conduits and, optionally, pneumatic conduits that regulate flow in the fluidic conduit. The microfluidic device can have valves, channels and reservoirs. For instance, figure 5 shows a microfluidic circuit, which contain valves and channels to mix different fluids. Furthermore, the embodiment that will be used here for the valve is shown in figure 23.) comprising: a fluidic channel; and a valve in fluidic communication with said fluidic channel (para [0080], [0072]; figure 5; Figure 5 shows a microfluidic circuit, which contain valves and channels to mix different fluids. Further, as seen in figure 5, the valves and the channels are in fluid communication.), wherein said valve comprises (i) a pneumatic layer configured to supply a positive or negative pressure (para [0018], [0040], [0055], [0005]; figures 1 and 23; Here, the embodiment used for the valve is shown in figure 23. Please note that some of the elements are not discussed in the text for the embodiment of figure 23, though these elements are shown in figure 23. These elements are though discussed for the embodiment in figure 1. The two embodiments (figure 1 and figure 23) share almost all of the elements, as seen in figures 1 and 23. The main difference is that figure 1 has a valve seat 103; whereas figure 23 has a recessed dome 115 that functions as a valve seat. In addition, the actuation layer 111 and actuation channel 112 numerals are backwards in figure 23, as compared to figure 1. Hence, from now on, reference may be obtained from the text discussing figure 1 (para [00181), when the elements that are shared between figures 1 and 23, are not mentioned for the text discussing figure 23 (para [00401). For instance, here, the bottom layer comprising elements 111, 112, 113 can be thought as the actuation layer. Further, when the actuant is a gas, e.g., air, the actuation layer functions as a pneumatics layer. In addition, the actuation layer comprising at least one actuation conduit configured to transmit positive or negative pressure to the elastic layer.), (ii) a fluidic layer (para [0040]; figure 23; A fluidics layer 101 comprises a fluid conduit comprising a fluidic channel 102.), and (iii) a membrane sandwiched between said pneumatic layer and said fluidic layer (para [0040], (0018], [0055]: figures 1 and 23; Elastic layer 105 can be thought as the membrane here. Further, as seen in figure 23, elastic layer 105 is sandwiched between the actuation/pneumatic layer (111, 112, 113), and the fluidics layer 101.), wherein said pneumatic layer is configured to apply said positive or negative pressure to said membrane to deflect said membrane towards or away from said fluidic layer, to thereby subject fluid to movement to or from said fluidic channel (para [0005], [0055], [0040], [0072]: figures 5 and 23.
The actuation layer comprising at least one actuation conduit configured to transmit positive or negative pressure to the elastic layer. Further, when the actuant is a gas, e.g., air, the actuation layer functions as a pneumatics layer. In addition, when no pressure or negative pressure is exerted on elastic layer 105, the elastic layer sits away from the valve seat, allowing for an open valve in which a fluid path between the channels entering the valve are in fluidic contact, creating a fluid path. When positive pressure is exerted on elastic layer 105, the elastic layer deforms toward the valve seat to close the valve. Furthermore, fluid flow in the second channel 108 is blocked by closure of valve 505 or another valve positioned on the second channel or on other channels that are connected to the second channel, as seen in figure 5. Hence, opening and closing the valves would subject fluid to movement to or from said fluidic channel.
Further, Kobrin teaches that the recessed dome 115 that functions as a valve seat and the sealing surfaces 106 are oriented at an angle of less than 90 degrees relative to a plane parallel to said support, for the embodiment of figure 23 (para [0040], [0018]; figures 1 and 23). Kobrin does not explicitly teach that the fluidic channel 102 is oriented at an angle of less than 90 degrees relative to a plane parallel to said support, for the embodiment of figure 23; and hence does not teach that: (ii) said fluidic layer comprises a surface that is oriented at an angle of less than 90 relative to a plane parallel to said support.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
However, Kobrin teaches that fluidic conduits and actuation conduits may be formed in the surface of the fluidic or actuation layer as furrows, dimples, cups, open channels, grooves, trenches, indentations, impressions and the like. Conduits or passages can take any shape appropriate to their function. This includes, for example, channels having, hemi-circular, circular, rectangular, oblong or polygonal cross sections (para [0052)).
Therefore, it would have been obvious to, within the common sense, knowledge and skill of one ordinary skilled in the art before the effective filing date of the invention to provide the fluid channel/conduit 102 with a suitable shape, with routine experimentation; such as using a fluidic channel of the valve having hemi-circular or circular cross section which would then render the embodiment of figure 23: (ii) said fluidic layer comprises a surface that is oriented at an angle of less than 90 relative to a plane parallel to said support; because fluidic conduits and actuation conduits may be formed in the surface of the fluidic or actuation layer as furrows, dimples, cups, open channels, grooves, trenches, indentations, impressions and the like. Conduits or passages can take any shape appropriate to their function. This includes, for example, channels having, hemi-circular, circular, rectangular, oblong or polygonal cross section (para [0052)). Further, in order to provide a valve that is durable, easily fabricated at low cost, can operate in dense arrays, and has low dead volume (para [00811). Furthermore, in order to create a better seal for the valve (para [0058)). Further, depending on the material(s) used for elastic layer 105, and hence the surface energy and the degree of deflection (elastic properties) of the elastic layer 105 (para [0133), [0142]-[0144]; figure 23).
Kobrin further teaches a microfluidic device wherein said plurality of valves comprises low dead-volume valves (para [0081]. [0072): figure 5; The diaphragm valves, pumps, and routers are durable, easily fabricated at low cost, can operate in dense arrays, and have low dead volumes. Further, figure 5 shows a microfluidic circuit, which contain valves and channels to mix different fluids.).
Kobrin does not specify that such valves are zero dead-volume valves including a channel with a curved surface. However, such zero dead-volume valves were previously known in the art.
Maerkl discloses a microfluidic device comprising channels and valves comprising channels. As shown in figure 11, the device comprises a valve having a flow channel with a curved upper surface. ([0033]). Since such valves are actuated by moving the roof of the channels themselves (i.e.: moving membrane 25) valves and pumps produced by this technique have a truly zero dead volume. ([0137]). An advantage of having such a curved upper surface at membrane 25A is that a more complete seal will be provided when flow channel 32 is pressurized. (paragraphs 0161-162, 164-166, 169).
Therefore, it would have been obvious to, within the common sense, knowledge and skill of one ordinary skilled in the art before the effective filing date of the invention to recognize that the valves of Kobrin may alternatively be zero dead volume valves including channels with a curved surface to provide for complete sealing with the membrane and to control and regulate fluid flow in the microfluidic device of Kobrin as taught by Maerkl as such would provide for predictable results.
As to claims 74-75, Kobrin does not teach that said membrane comprises at least two polymeric layers. Kobrin teaches that devices of this invention also can be provided that have functional surfaces treated to decrease their surface energy. The elastic layer (membrane) can be made of PDMS. Further, many materials are useful to create low surface energies on exposed surfaces, such as perfluorinated polymers (para [0142)-(01431). Therefore, it would have been obvious to one ordinary skilled in the art to treat the surface of the elastic layer (membrane) with a low surface energy material, such as for example: coating the elastic layer (membrane) comprising PDMS with a low energy polymer; thus resulting in said membrane comprises two polymeric layers: in order to provide an elastic layer (membrane) that has a decreased surface energy. Low surface energies decrease sticking of the elastic layer (membrane) to the fluidics or actuation layer to which it is attached. Many materials (including different materials) are useful to create low surface energies on exposed surfaces. In one embodiment, the material is a low energy polymer such as a perfluorinated polymer (para [0142)-(0143)). Further, because PDMS provides a deformable layer (para [00671). The membrane Cn comprise different materials; in order to provide a valve that is durable, easily fabricated at low cost, can operate in dense arrays, and has low dead volume (para [0081]).
As to claim 77, Kobrin further teaches a microfluidic device wherein said pneumatic layer and said fluidic layer are made from materials comprising poly(methyl methacrylate) (PMMA) and polystyrene (PS) (para [0095), [0055); The plastic layer, e.g., fluidics and/or actuation layers, of the device may be made out of any plastic. This includes, without limitation, a polymethylmethoxyacrylate (PMMA) and a polystyrene. Further, when the actuant is a gas, e.g., air, the actuation layer functions as a pneumatics layer.
As to claim 78, Kobrin does not explicitly teach a microfluidic device wherein said fluidic layer has a depth between about 1 micron and about 1,000 microns. However, it would have been obvious to one ordinary skilled in the art to determine proper dimensions for the layers. with routine experimentation; such as for example: said fluidic layer has a depth between about 1 micron and about 1,000 microns; in order to provide a valve that is durable, easily fabricated at low cost. can operate in dense arrays, and has low dead volume (para (00811). Further, in order to avoid deformities, including cracking or breaking, of one of the substrates (para (00481). Further, depending on the deforming dimension (para (01331), and the number of valves, pumps, and channels for the microfluidic device (para (00821).
It would have been an obvious matter of design choice to provide for a depth within the recited range, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
As to claim 79, Kobrin does not explicitly teach a microfluidic device wherein said depth is more than 10 microns. However, it would have been obvious to one ordinary skilled in the art to determine proper dimensions for the layers, with routine experimentation; such as for example: said depth is more than 10 microns; in order to provide a valve that is durable, easily fabricated at low cost, can operate in dense arrays, and has low dead volume (para [00811). Further, in order to avoid deformities, including cracking or breaking, of one of the substrates (para (00481). Further, depending on the deforming dimension (para (01331), and the number of valves, pumps, and channels for the microfluidic device (para (00821).
It would have been an obvious matter of design choice to provide for a depth within the recited range, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
As to claim 80, Kobrin does not specifically teach a microfluidic device wherein said fluidic channel has a width that is at least 2 times a depth of said fluidic channel. However, it would have been obvious to one ordinary skilled in the art to provide the fluidic channel with proper dimensions, such as for example: said fluidic channel has a width that is at least 2 times a depth of said fluidic channel; because in some embodiments, a microchannel in a microfluidics chip device can have a width greater than 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, or 300 microns; and in some embodiments, a microchannel has a depth of up to or less than 100, 90, 80, 70, 60, 50, 40, 30 or 20 microns (para (00971). Further, in order for the microchannels to be designed and configured to manipulate samples and reagents for a given process or assay (para [0097]).
As to claim 81-82, Kobrin further teaches a microfluidic device wherein said valve remains open and closed in the absence of said application of said positive or negative pressure to said plurality of pneumatic channels (para [0072], [0149), [0005], [0055], [0040]; figures 5 and 23; Figure 5 shows a microfluidic circuit, which contain valves and channels to mix different fluids. The actuant delivery assembly can comprise a source of positive or negative pressure and can be connected to the actuation conduits through transmission lines. Further, the at least one actuation conduit configured to transmit positive or negative pressure to the elastic layer. Furthermore, when the actuant is a gas. e.g., air. the actuation layer functions as a pneumatics layer. In addition, when no pressure or negative pressure is exerted on elastic layer 105, the elastic layer sits away from the valve seat, allowing for an open valve in which a fluid path between the channels entering the valve are in fluidic contact, creating a fluid path. When positive pressure is exerted on elastic layer 105, the elastic layer deforms toward the valve seat to close the valve.).
As to claim 83, Kobrin teaches the microfluidic device of claim 22; and Kobrin further teaches a microfluidic device wherein said microfluidic device comprises a plurality of valves (para (0072); figure 5; Figure 5 shows a microfluidic circuit, which contain valves and channels to mix different fluids.).
As to claim 88, Kobrin does not explicitly teach a microfluidic device wherein each of said plurality of valves is independently actuated by a different pneumatic channel and regulate the flow through a plurality of fluidic channels.
However, it would have been obvious to, within the common sense, knowledge and skill of one ordinary skilled in the art before the effective filing date of the invention for a skilled artisan without undue experimentation to realize that plurality of valves can either be actuated by the same or different pneumatic channels. Therefore, it would have been obvious to one ordinary skilled in the art to determine the number of actuators, with routine experimentation; such as for example: each of said plurality of valves is independently actuated by a different pneumatic channel; in order to provide a valve that is durable, easily fabricated at low cost, can operate in dense arrays, and has low dead volume (para [00811); depending on the functionality of the valve (para [00601); the variety of the flow rates that can be achieved (para (0071 ]); and the type of analysis in which the microfluidic is utilized (para [0152]-[0154]); and the type(s) of actuations sources used (para [01491).
Kobrin discloses that the device may be controlled via a computer coupled to a network. (paragraphs 0083, 149-150, 152, 159, 166).
As to claim 90, Kobrin teaches the microfluidic device of claim 1; and Kobrin further teaches a microfluidic device wherein said microfluidic device is monolithic (para [0007];
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN R GORDON/ Primary Examiner, Art Unit 1798