DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
Claims 9-10 and 17 require ceasing to expose a droplet to a magnetic field. However, magnetic fields of a permanent magnet as in Applicant’s specification are infinite, merely becoming weaker with greater distance. Therefore, the recitation is interpreted in accordance with Applicant’s specification reciting “Usually, the step of ceasing to expose the droplet to said magnetic field comprises moving the magnet away from the droplet. Typically, the magnet is a permanent magnet and ceasing to expose the droplet to said magnetic field usually requires the magnet to be moved away from the droplet so that the droplet is no longer attracted to the magnet.”
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 20 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.
Claim 20 recites “A droplet assembly obtained by a process as defined in claim 1.” Wherein this claim is interpreted as a use claim reading wherein the process is used to produce a droplet assembly. Thereby, such use steps must be defined, such steps resulting in the droplet assembly being indefinitely defined and as to what using the process constitutes.
Presently, the claim is presented as an intended usage of the process of claim 1 without any further particulars thereto in providing for different sought product “droplet assemblies.”
Further, the process itself of Claim 1 does not result in a coalescence of droplets, as indicated by referring to the droplets as an “assembly” in Claim 20, the final step in Claim 1 being to separate the droplets. Thereby, it is further unclear as to how the process results in an assembly of droplets. Further, the term “droplet assembly” is not utilized in Claim 1 so as to correlate and make clear those droplet assemblies attainable by that of claim 1.
See also MPEP 2173.05(q).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-8, 11-16, and 18-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hernandez et al. (WO 2007/101174 A2), hereinafter “Hernandez”, in view of Bayley et al. (US 2010/0032627 A1), hereinafter “Bayley”.
Regarding Claim 1, Hernandez teaches a process for moving a droplet from a first location to a second location (Abstract: “droplets can be moved, immobilized, dispensed, coalesced, and/or divided”), which process comprises:
(i) exposing a droplet which is situated at a first location, which droplet comprises (a) an aqueous medium ([00172]: “the aqueous fluid comprises at least one of water...”), and (c) a magnetic material disposed in the aqueous medium, to a magnetic field of a magnet ([0076]: “Disclosed are methods of moving and controlling droplets of fluids on hydrophobic surfaces through the use of magnetic fields. Small water drops (volume 5-20 μL) that contain fractions of paramagnetic particles as low as, for example, 0.1% wt/wt can be moved on a superhydrophobic surface at relatively high speed (7 cm/s) by displacing a permanent magnet.”), and thereby causing the droplet to be attracted to said magnet by magnetic attraction ([00190]: “The movement of water drops on horizontal surfaces was due to the application of a magnetic field that aligns paramagnetic particles, attracts them to the magnet, and moves the drop of water in the process.”);
(ii) moving the magnet relative to the first location whilst maintaining said magnetic attraction, and thereby causing the droplet to move away from said first location and towards a second location and (iii) disposing the droplet at said second location, ([00200]: “an aqueous solution to be analyzed can be combined with other drops sequentially for sample pretreatment reasons and subsequently moved to another location for analysis”); as in Claim 1.
Further regarding Claim 1, Hernandez does not specifically teach the process discussed above wherein the droplet comprises (b) an outer layer of amphipathic molecules on at least part of the surface of the aqueous medium, nor wherein the droplet at the first location forms a bilayer with a further droplet, wherein the further droplet comprises (a) an aqueous medium and (b) an outer layer of amphipathic molecules around the surface of the aqueous medium, and causing the droplet at the first location to move away from the further droplet and the bilayer between the droplet at the first location and the further droplet to separate, as in Claim 1.
However, Bayley teaches a respective droplet actuation device where droplets of aqueous solution are covered in an amphipathic substance (See Fig. 2.) and amphipathic liquid bilayers are formed by merging two droplets together, the second droplet further having an aqueous and a non-aqueous amphipathic component (Abstract: “A layer of amphipathic molecules such as a lipid is formed around the surfaces of the droplets. This may be achieved by providing the lipid in the oil and leaving the droplets for a time sufficient to form the layer. The droplets are brought into contact with one another so that a bilayer of the amphipathic molecules is formed as an interface between the contacting droplets.”) wherein the droplet at a first location is moved away from a further adjoining droplet and the bilayer between the droplets is separated ([0027]: “The formation of the bilayers is also highly reversible and repeatable. Droplets which have been brought into contact with one another may be freely separated to divide the bilayer and may be subsequently brought into contact again to re-create the bilayer.”). Therein, one of ordinary skill in the art would recognize such droplet bilayer manipulation as within the scope of magnetic droplet microfluidics, thereby enabling such magnetic components to be used for the additional purpose of bilayer formation.
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 process of Hernandez wherein the droplet comprises (b) an outer layer of amphipathic molecules on at least part of the surface of the aqueous medium, nor wherein the droplet at the first location forms a bilayer with a further droplet, wherein the further droplet comprises (a) an aqueous medium and (b) an outer layer of amphipathic molecules around the surface of the aqueous medium, and causing the droplet at the first location to move away from the further droplet and the bilayer between the droplet at the first location and the further droplet to separate, so as to enable such experiments in Hernandez.
Further note that Bayley para. [0013] recites: “Indeed the manner in which droplets are moved is not critical as the droplets are robust and easily manipulated. Examples of suitable apparatus for handling the droplets are given below, but are not limitative.”
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez teaches the process discussed above wherein (i) exposing a droplet to said magnetic field comprises moving said magnet relative to the droplet which is situated at the first location, in a direction towards the droplet, and thereby causes the droplet to be attracted to said magnet by magnetic attraction ([00269]: “As illustrated in Figure 31, three different aqueous microdroplets - serving as the "Sample," "Blank," and "Wash" solutions (containing 2% w/v polysiloxane-coated iron microparticles) - were moved magnetically in air, towards and away from a three-electrode assembly, by moving different external magnets below the superhydrophobic surface.”), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez teaches the process discussed above wherein (i) exposing a droplet to said magnetic field causes the droplet to move away from said first location and towards the magnet ([00190]: “The movement of water drops on horizontal surfaces was due to the application of a magnetic field that aligns paramagnetic particles, attracts them to the magnet, and moves the drop of water in the process.”), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez does not specifically teach the process discussed above wherein the droplet at the first location and the further droplet are disposed in a hydrophobic medium, as in Claim 4.
However, Bayley teaches the amphipathic droplets as being in a hydrophobic medium ([0010]: “forming a plurality of droplets of aqueous solution in a hydrophobic medium with a layer of amphipathic molecules around the surfaces of the droplets”) to allow for easy formation of the droplets ([0013-0014]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Hernandez in view of Bayley, to provide the first droplet and the further droplet as disposed in a hydrophobic medium, such as suggested by Bayley, so as to enable easy formation of the droplets.
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Hernandez does not specifically teach the process discussed above wherein the droplet at the first location is disposed on a solid surface in a hydrophobic medium, as in Claim 5.
However, Bayley teaches actuating droplets along a lower chamber surface on which the hydrophobic medium is exposed (See [0031] for example.) so as to provide a physical barrier defining a dimension of movement of the droplet, and to provide a barrier so as to contain the hydrophobic medium.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Hernandez in view of Bayley, to provide the droplets as disposed on a solid surface in a hydrophobic medium, such as suggested by Bayley, so as to provide a physical barrier defining a dimension of movement of the droplet, and to provide a barrier so as to contain the hydrophobic medium.
Regarding Claim 6, the prior art meets the limitations of Claim 4 as discussed above. Further, Hernandez in view of Bayley teaches the process discussed above wherein the magnet is above the hydrophobic medium (Hernandez [00269]: “external magnets below the superhydrophobic surface”, therein, “above” is a relative term considered to be encompasses by the position of magnets adjacent to the platform.) and wherein (i) exposing a droplet to said magnetic field causes the droplet to rise to the top of the hydrophobic medium (When the medium is implemented with the magnetics system of Hernandez, the magnetic amphipathic particle in the oil will be attracted to the magnet and rise to approach its position. Therein, “top” is a relative term considered to be accounted for by the droplets of Hernandez being pulled down. Applicant may wish to specify the droplet movement as being “away from the surface”.), as in Claim 6.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that the combined Hernandez in view of Bayley would exhibit the behavior wherein exposing the droplet to the magnetic field causes the droplet to “rise to the top” of the hydrophobic medium.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez teaches the process discussed above wherein (ii) moving the magnet relative to the first location moves the magnet in a direction away from the first location whilst maintaining said magnetic attraction, and thereby causes the droplet to move away from said first location and towards a second location ([00190]: “The movement of water drops on horizontal surfaces was due to the application of a magnetic field that aligns paramagnetic particles, attracts them to the magnet, and moves the drop of water in the process.”), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez teaches the process discussed above wherein (ii) moving the magnet relative to the first location moves a single droplet (See Abstract discussing single correspondence between a magnetic field and a droplet “a magnetically active fluid droplet in contact with the surface; and a magnetic field coupled with at least a portion of the droplet”), as in Claim 8.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez in view of Bayley teaches the process discussed above wherein (iii) disposing the droplet at said second location comprises bringing the droplet into contact with an other droplet, which other droplet comprises (a) an aqueous medium and (b) an outer layer of amphipathic molecules around the surface of the aqueous medium, so that a bilayer of amphipathic molecules is formed at an interface between the contacting droplets (See the rejection of Claim 1 above regarding separation of the bilayer, and see Bayley [0013] regarding bringing droplets together to form the bilayer.), as in Claim 11.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Hernandez in view of Bayley, to provide wherein (iii) disposing the droplet at said second location comprises bringing the droplet into contact with an other droplet, which other droplet comprises (a) an aqueous medium and (b) an outer layer of amphipathic molecules around the surface of the aqueous medium, so that a bilayer of amphipathic molecules is formed at an interface between the contacting droplets, such as suggested by Bayley, so as to provide the means of bilayer formation in Bayley and the experimental benefits and model systems thereof.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez in view of Bayley teaches the process discussed above wherein (iii) disposing the droplet at said second location comprises bringing the droplet into contact with more than one other droplet, wherein each other droplet comprises (a) an aqueous medium and (b) an outer layer of amphipathic molecules around the surface of the aqueous medium, so that a bilayer of amphipathic molecules is formed at an interface between each of the contacting droplets (See Bayley [0074] discussing formation of droplet networks of more than two droplets, and see also Bayley Fig. 11.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Hernandez in view of Bayley, to provide wherein (iii) disposing the droplet at said second location comprises bringing the droplet into contact with more than one other droplet, wherein each other droplet comprises (a) an aqueous medium and (b) an outer layer of amphipathic molecules around the surface of the aqueous medium, so that a bilayer of amphipathic molecules is formed at an interface between each of the contacting droplets, such as suggested by Bayley, so as to provide the means of multi-bilayer formation in Bayley and the experimental benefits and model systems thereof.
Regarding Claim 13, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez teaches the process discussed above wherein (iii) disposing the droplet at said second location comprises contacting the droplet with a second droplet and fusing the droplet with the second droplet to form a new droplet from the first and second droplets ([00282]: “An attractive feature of the digital magnetomicrofluidic system is its ability to manipulate (merge or split) microliter droplets, including splitting of sample droplets or merging of sample and reagent ones.”), as in Claim 13.
Regarding Claim 14, the prior art meets the limitations of Claim 13 as discussed above. Further, Hernandez teaches the process discussed above which further comprises a step of moving the magnet relative to the second location in a direction away from the second location whilst maintaining said magnetic attraction, and thereby causing the new droplet to move away from said second location and towards a third location ([00200]: “an aqueous solution to be analyzed can be combined with other drops sequentially for sample pretreatment reasons and subsequently moved to another location for analysis.” – The “location for analysis” being the third location.), as in Claim 14.
Regarding Claim 15, the prior art meets the limitations of Claim 14 as discussed above. Further, Hernandez in view of Bayley teaches the process discussed above wherein the new droplet formed from the first and second droplets forms a bilayer with a third droplet and step of moving the magnet relative to the second location causes the new droplet to move away from the third droplet (Hernandez discusses pretreatment of droplets with reagents by merging sample and dragnet droplets before analysis ([00200]). Bayley teaches analysis by forming bilayers by contacting droplets together, and separating such bilayers by moving the droplets apart. Thus, when combined with Hernandez, the analysis location in Bayley is where the droplets are contacted and separated for analysis, the third location, and the second location is the location in Hernandez where droplets are merged.), as in Claim 15.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Hernandez in view of Bayley, to provide wherein the new droplet formed from the first and second droplets forms a bilayer with a third droplet and step of moving the magnet relative to the second location causes the new droplet to move away from the third droplet, so as to enable the bilayer studies beneficial in Bayley while maintaining the magnetic movement and reagent additions of Hernandez.
Regarding Claim 16, the prior art meets the limitations of Claim 14 as discussed above. Further, Hernandez teaches the process discussed above which further comprises disposing the new droplet at said third location ([00200]: “an aqueous solution to be analyzed can be combined with other drops sequentially for sample pretreatment reasons and subsequently moved to another location for analysis.”), as in Claim 16.
Regarding Claim 18, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez in view of Bayley teaches the process discussed above wherein the further droplet is one of two or more further droplets, and the droplet at the first location forms a bilayer with each of said two or more further droplets, wherein each further droplet comprises (a) an aqueous medium and (b) an outer layer of amphipathic molecules around the surface of the aqueous medium, and exposing the droplet at the first location to said magnetic field causes the droplet at the first location to move away from the further droplets and each bilayer between the droplet at the first location and the further droplets to separate (See Bayley [0074] discussing formation of droplet networks of more than two droplets, and see also Bayley Fig. 11. See also the rejection of Claim 1 above regarding separating the droplets.), as in Claim 18.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Hernandez in view of Bayley, to provide wherein the further droplet is one of two or more further droplets, and the droplet at the first location forms a bilayer with each of said two or more further droplets, wherein each further droplet comprises (a) an aqueous medium and (b) an outer layer of amphipathic molecules around the surface of the aqueous medium, and exposing the droplet at the first location to said magnetic field causes the droplet at the first location to move away from the further droplets and each bilayer between the droplet at the first location and the further droplets to separate, such as suggested by Bayley, so as to provide the means of multi-bilayer formation in Bayley and the experimental benefits and model systems thereof.
Regarding Claim 19, the prior art meets the limitations of Claim 1 as discussed above. Further, Hernandez in view of Bayley teaches the process discussed above wherein the amphipathic molecules comprise phospholipid molecules (See Bayley [0034].), as in Claim 19.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Hernandez in view of Bayley, to provide wherein the amphipathic molecules comprise phospholipid molecules, such as provided by Bayley, so as to provide a sufficient lipid species for achieving bilayer formation as in Bayley.
Regarding Claim 20, Hernandez in view of Bayley teaches a droplet assembly obtained by a process as defined in claim 1 (See the above rejection of Claim 1 discussing formation of droplet assemblies by magnetic actuation as provided by Hernandez, of amphipathic encapsulated droplets as in Bayley.), as in Claim 1.
Claims 9-10 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hernandez in view of Bayley, as applied to Claims xx above, and in further view of Shikida et al. (US 2008/0226500 A1), hereinafter “Shikida.
Regarding Claims 9-10 and 17, Hernandez in view of Bayley does not specifically teach wherein (iii) disposing the droplet/new droplet at said second/third location comprises ceasing to expose the droplet to said magnetic field at or near said second/third location, as in Claims 9-10 and 17.
However, Shikida teaches a respective magnetic droplet actuating system where droplets are actuated along a surface by permanent magnets or electromagnets, and when the droplet is disposed at its destination, the permanent magnet is moved away from the droplet, ceasing to expose it to the magnetic field in a strength suitable for movement (interpreted equivalent as the claimed “ceasing to expose” given that magnetic fields theoretically extend infinitely, their strength merely diminishing), or switching off the electromagnet to remove the magnetic field ([0076-0078]), thereby allowing the magnetic particles to disperse in the droplet and hasten chemical reaction processes ([0020]).
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 process of Hernandez in view of Bayley wherein (iii) disposing the droplet/new droplet at said second/third location comprises ceasing to expose the droplet to said magnetic field at or near said second/third location, such as suggested by Shikida, so as to allow the magnetic particles to disperse in the droplet and hasten chemical reaction processes.
Regarding Claim 10 and the “allowing the droplet to arrive at said second location by falling through a hydrophobic medium under gravity” recitation, Hernandez teaches use of gravity to move droplet positions across the hydrophobic surface ([00213]: “allowing the droplet to arrive at said second location by falling through a hydrophobic medium under gravity” – [00192]: “On inclined superhydrophobic surfaces, smaller water drops actually roll down faster than larger drops which slide down the inclined surface.”), thereby accounting for the recitation in Claim 10.
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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