The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 1, 14, 23, 38-40 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 2015/0226726) in view of Rabenecker (US 5,312,593). In the patent publication Beck teaches a method for recovering one or more nonvolatile compounds from an exhaled aerosol collected on an electrostatic filter membrane (205) comprises eluting the nonvolatile compounds from the filter with a polar solvent and collecting the eluate. The method is useful for processing samples collected from a portable breath analysis device comprising a sampling filter membrane for analysis. In particular with respect to claim 1, Beck teaches a sample collection system comprising: a sample collection device comprising (see at least figure 1 and its associated description): a housing (housing 204) comprising an airflow path extending from a proximal end comprising an air inlet (inlet 203) to a distal end (paragraph [0028], exhaled breath exits the housing through at least one outlet 206); and a sample collector comprising porous sample collection media arranged to occlude the airflow path (sampling membrane 205; paragraph [0029], the sampling membrane 205 is fastened to the inner walls of the housing 204 and stretched over the cross-section of the housing; paragraph [0035], the filter membrane is placed to block the path for the exhaled breath through the portable system); and an eluent delivery element (see paragraph [0055], filter 205 is preferably in the housing 204 of the sampling device with the solvent being passed though the device from one of the inlet 203 or outlet 206 to the other of the inlet 203 or outlet 206 of the device). Beck does not teach that a piercing element is arranged within the airflow path or that the eluent delivery element is a reservoir containing the eluent; with a membrane disposed at a coupling end of the reservoir and sealing the reservoir, the coupling end being constructed to couple with the proximal end of the airflow path and be at least partially received within the airflow path such that the piercing element pierces the membrane.
In the patent Rabenecker describes a detecting device in the form of a testing tube or dosimeter having a carrier indicating a color reaction requires a reagent liquid for carrying out a measurement. The reagent liquid is contained in a separate reagent supply vessel and the carrier is impregnated with a color indicator. For carrying out a measurement, the reagent supply from the supply vessel must be brought into contact with the porous carrier. A uniform wetting of the surface of the carrier subjected to the reagent solution is achieved after the reagent solution is emptied from the supply vessel. This is achieved by providing a reagent collection chamber between the carrier and the reagent supply vessel into which the reagent solution pours when the supply vessel is opened and wherein the reagent solution is accommodated and into which the carrier extends so that its end face is subjected to the reagent solution so that this end face can be wetted at the same time. Figure 1, in particular, shows a colorimetric detecting device with a housing containing a receiving holder 2 for a reagent supply vessel 3 and an insert 4 for accommodating a porous carrier 5. The carrier 5 is held in the carrier insert 4 by a clamping ring 12. The receiving holder 2 and the carrier insert 4 are connected to each other via a siphon-like channel defining a reagent collection chamber 6. The carrier 5 with its end face 7 extends into the reagent collection chamber 6. This end face 7 is subjectable to the reagent. A substance region 8 extends from the end face 7 and is impregnated with the reaction constituents necessary for the color reaction. The reaction constituents can, for example, be chromogens, additional substrates or activators. The impregnation can be realized by freeze drying onto the porous carrier. The carrier insert 4 has an inlet opening 9 through which the test quantity to be detected has access to the detecting surface 10 of the carrier 5. A color change taking place in the course of the measurement is visible by means of the inlet opening 9. The detecting region 11 follows the detecting surface 10 in the carrier 5 and contains the detecting substances necessary for the color change. For an enzymatic detection, these substances are, for example, the enzymes catalyzing the reaction. In the form illustrated, the particular reactants are spatially separated from each other in the carrier 5 in the substance region 8 and detection region 11, respectively. The reagent supply vessel 3 rests on a thorn-like projection 15 in the receiving holder 2 and is covered with a cap 16 with respect to the housing 1. The cap 16 can be pressed downwardly a distance (a) up to a depth stop 40 in the direction of arrow 17. When the cap 16 is pressed to the stop 40, the supply vessel 3 is penetrated at its penetrable wall 18 by the thorn 15 so that the reagent liquid pours from the supply vessel 3 through the opening formed in the wall 18 and into the reagent collection chamber 6. While pressing the cap 16 downwardly, a vent opening 20 is held closed so that during pressing in the direction of arrow 17, the reagent liquid 19 is forcibly pushed through the penetrated wall 18 into the collection chamber 6. After releasing the vent opening 20, the residual of the reagent liquid 19 pours from the supply vessel 3 into the collection chamber 6 so that the reagent liquid 19 is brought into contact with the end face 7 of the carrier 5 at the pass-through opening 21 of the collection chamber 6. The dissolved reaction constituents in the substance region 8 are transported through the carrier 5 up to the detecting region 11 via the capillary forces of the porous carrier 5. The reaction constituents combine with the detecting substance in dissolved form and thereby are suitable for analyzing a test quantity as a substrate for the enzyme. The test quantity can, for example, be an air sample from the ambient which reaches the detecting surface 10 via diffusion or the test quantity can be a liquid which, for example, is applied to the detecting surface via a pipette and thereafter dries onto the carrier.
With respect to claim 1, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the Beck system with a piercing element arranged within the airflow path and a reservoir containing the eluent with a membrane disposed at a coupling end of the reservoir that seals the reservoir, the coupling end being constructed to couple with the proximal end of the airflow path and be at least partially received within the airflow path such that the piercing element pierces the membrane as taught by Rabenecker because Beck teaches adding an eluent through the airflow path and because of the ability to cause the eluent to contact the sample collector in a controlled, uniform manner as taught for the structure of Rabenecker (see at least column 2, lines 41-57).
With respect to claim 14, the teachings of Beck appear to show the housing of figure 1 with a longitudinal axis that is made of at least two parts (see at least paragraphs [0029] and [0038]) and Rabenecker shows/teaches their piercing element extending parallel to the longitudinal center axis associated with the portion of the path that the reservoir couples with. Thus, it would have been obvious to one of ordinary skill in the art at the time the application was filed to have the piercing element extend parallel to the longitudinal center axis of the Beck airflow path as required by claim 14 for the reasons given above for claim 1.
With respect to claim 23, the device of Rabenecker shows/teaches their reservoir as having an uncoupled position and a coupled position where the fluid delivery element is coupled with the sample collection device, and wherein the fluid delivery element is constructed to deliver a metered dose of fluid from the reservoir onto the porous sample collection media in the coupled position. Thus, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the Beck airflow path as required by claim 23 for the reasons given above for claim 1.
With respect to claims 38-40, paragraphs [0011], [0041] and [0054] of Beck teach (also see claims 1, 4 and 7) that the porous sample collection media (the filter membrane) is nonwoven material made from polylactic acid, polypropylene, or a combination thereof and is preferably electrostatic (carries an electrostatic charge).
With respect to claim 42, Beck teaches a method of using the above described device including breathing into the proximal end of the airflow path to collect a sample on the porous sample collection media (see figure 2 with its description in paragraphs [0047]-[0053]) and collecting an eluent from the porous sample collection media (see figure 3 and its associated description in paragraphs [0054]-[0057)]). Beck does not teach coupling the coupling end of the eluent delivery element with the proximal end of the airflow path; and transferring a metered dose of the eluent from the reservoir onto the porous sample collection media to elute the collected sample from the porous sample collection media. These steps are inherent in the use of the Rabenecker fluid reservoir device so that claim 42 would have been obvious over the teachings of Beck in view of Rabenecker for the reason given above for claim 1.
Claims 1-3, 14, 19, 23, 35 ad 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 2015/0226726) in view of Engbersen (US 2015/0182156). In the patent publication Beck teaches a method for recovering one or more nonvolatile compounds from an exhaled aerosol collected on an electrostatic filter membrane (205) comprises eluting the nonvolatile compounds from the filter with a polar solvent and collecting the eluate. The method is useful for processing samples collected from a portable breath analysis device comprising a sampling filter membrane for analysis. In particular with respect to claim 1, Beck teaches a sample collection system comprising: a sample collection device comprising (see at least figure 1 and its associated description): a housing (housing 204) comprising an airflow path extending from a proximal end comprising an air inlet (inlet 203) to a distal end (paragraph [0028], exhaled breath exits the housing through at least one outlet 206); and a sample collector comprising porous sample collection media arranged to occlude the airflow path (sampling membrane 205; paragraph [0029], the sampling membrane 205 is fastened to the inner walls of the housing 204 and stretched over the cross-section of the housing; paragraph [0035], the filter membrane is placed to block the path for the exhaled breath through the portable system); and an eluent delivery element (see paragraph [0055], filter 205 is preferably in the housing 204 of the sampling device with the solvent being passed though the device from one of the inlet 203 or outlet 206 to the other of the inlet 203 or outlet 206 of the device). Beck does not teach that a piercing element is arranged within the airflow path or that the eluent delivery element is a reservoir containing the eluent; with a membrane disposed at a coupling end of the reservoir and sealing the reservoir, the coupling end being constructed to couple with the proximal end of the airflow path and be at least partially received within the airflow path such that the piercing element pierces the membrane.
In the patent publication Engbersen teaches a test device (1) for testing a human or animal sample, such as blood or blood components, comprising a first part (2) and a second part (3), comprising co-operating first and second coupling elements (4, 5) for coupling the first part with the second part, and a sample absorbing and/or adsorbing element (17), wherein the first part comprises a fluid reservoir (20), and wherein the second part comprises at least one receptacle, wherein the fluid reservoir is reducible in volume for forcing a liquid contained therein through and/or along the adsorbing and/or absorbing element, forcing the sample such as blood or components thereof from the adsorbing and/or absorbing element into the receptacle, preferably into contact with at least one reagent (16) in the second part when the first and second part are connected or brought into connection with each other by at least the first and second coupling elements. Paragraph [0006] teaches that a sample absorbing and/or adsorbing element, which can be provided in the first or second part or in a separate part in between the first and second part. Paragraph [0007] teaches that the fluid can be forced into and/or through the element, to dissolve and/or dilute the sample (blood) prior to being forced through the filter. The reservoir, especially the construction for reducing the volume of the reservoir and thus defining the amount of fluid to be passed through the element, and the element define specific amounts of the sample, such as blood and fluid passed through the filter, such that the dilution factor is defined. This can increase the accuracy of the reaction with the reagent. A blood absorbing and/or adsorbing element 17 is provided. Preferably the type and volume of the material of the element 17 is chosen such that the element can absorb a predefined amount of sample. The first element 4 can for example be press fit into the second element 5 or vice versa. Paragraph [0033] teaches that the first part 2 comprises a fluid reservoir 20 at a side of the element 17 facing away from the free surface 18 thereof, such that any fluid coming from said reservoir 20 can only leave the first part through the element 17 and through the filter 12 when the first and second part 2, 3 are connected properly. The reservoir 20 is reducible in volume, in order to force an amount of fluid 21 contained therein out, through the element 17 and the filter 12. This has the advantage that all fluid leaving the reservoir is forced through the element 17 and thus dilutes the blood absorbed therein before passing through the filter 12. The reservoir 20 is preferably provided opposite the free surface 18 thereof. Preferably the first part 2 is provided with a mechanism 23 for guiding the reduction of the volume between a maximum volume and a minimum volume or maximally reduced volume. Preferably the volume of fluid 21 in the reservoir 20 is chosen such that in the maximum volume position the reservoir is substantially entirely filled with fluid. By defining a maximally reduced volume, the amount of fluid being forced through the element 17 is thus defined and therefore the dilution rate is defined. This may increase the accuracy of the test. Paragraph [0035] teaches that the fluid reservoir 20 can include a chamber 24 and a plunger 25, movable relative to said filter 12 for reducing the volume of the reservoir 20. An outlet 26 is provided for the reservoir 20, opening toward the at least one adsorbing and/or absorbing element 17. Paragraph [0040] teaches that a seal 46 (membrane) is provided in or on said opening 45 (see at least figure 2). In the initial, first or maximum volume position as shown in figure 2, a space 51 is provided between the lower end wall 44 of the plunger element 40 and the bottom part 49. In the space 51 a piercing element 52, such as a needle or spike is provided, with a sharp end 53 facing the opening 45 and directly adjacent the seal 46. Paragraph [0041] teaches that in the first, initial position, the chamber 24 is completely filled with the fluid 21. Thus, if the grip 26 is brought towards the end part 49, the seal 46 is pressed against and over the piercing element 52, opening the chamber 24 towards the space 51. Fluid will flow from the reservoir 20 and into the channel 50. Moving the grip 26 further will first force the end wall 44 against the bottom part 49, limiting the movement of the plunger element 40. Further movement of the grip will then bring the upper end wall 47 further towards the bottom part 49, thus reducing the volume of the chamber 24 and therefore of the reservoir 20, forcing more fluid out of the chamber 24 and into the space 51 and channel 50 under controlled pressure. The fluid is forced into and through the element 17, through the filter 12 and the fluid connection 22, which can comprise or connect to channel 13, and into contact with the reagent 16. In the element 17 blood is diluted by the fluid, where after the combined fluid and blood are filtered by the filter 12, prior to coming into contact with the reagent 16. As a filtrate therefore the fluid with plasma will leave the filter. Since the grip has a fixed start position and a fixed end position, the amount of fluid leaving the chamber 24 is well defined, and therefore the dilution ratio is well defined.
With respect to claim 1, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the Beck system with a piercing element arranged within the airflow path and a reservoir containing the eluent with a membrane disposed at a coupling end of the reservoir that seals the reservoir, the coupling end being constructed to couple with the proximal end of the airflow path and be at least partially received within the airflow path such that the piercing element pierces the membrane as taught by Engbersen because Beck teaches adding an eluent through the airflow path and because of the ability of such a configuration to release a defined volume of fluid leading to an increase in the accuracy of the interaction as taught by Engbersen.
With respect to claims 2-3, 21 and 41, at least paragraphs [0053] and [0056]-[0057] of Beck teach the collection and delivery of the eluate to an analysis/assay system but not that the analysis/assay system is a lateral flow assay adjacent to the porous sample collection media. Figure 12 and the description of paragraph [0057] of Engbersen teach that the filtrate/eluate from the embodiments described in figures 2-3 and 11 can be received in a receptacle for storage, transport and/or treatment and/or testing in a different manner than by reagents and paragraph [0074] teaches the providing of kits including the device. Figures 2-3 and their associated description teach that the filtrate is brought into contact with a reagent (16). Paragraph [0030] teaches that the reagent can take the form of a lateral flow assay. Paragraph [0104] teaches a specific lateral flow immunoassay for a particular test. Thus, it would have been obvious to one of ordinary skill in the art at the time the application was filed to provide the device of Beck with a lateral flow assay in a manner taught by Engbersen and/or in the form of a kit because Beck teaches analysis of recovered eluate and Engbersen clearly teaches the use of a lateral flow assay as an alternate structure to eluate recovery for providing an analysis.
With respect to claim 14, the teachings of Beck appear to show the housing of figure 1 with a longitudinal axis that is made of at least two parts (see at least paragraphs [0029] and [0038]) and both Engbersen shows/teaches their piercing element extending parallel to the longitudinal center axis associated with the portion of the path that the reservoir couples with. Thus, it would have been obvious to one of ordinary skill in the art at the time the application was filed to have the piercing element extend parallel to the longitudinal center axis of the Beck airflow path as required by claim 14 for the reasons given above for claim 1.
With respect to claim 19, at least one of the piercing elements of Engbersen has a hollow center extending from an open first end to an opposing open second end so that claim 19 would have been obvious to one of ordinary skill in the art over the teachings of Beck in view of Engbersen for the reasons given above for claim 1.
With respect to claim 23 the devices of Engbersen shows/teaches their reservoir as having an uncoupled position and a coupled position where the fluid delivery element is coupled with the sample collection device, and wherein the fluid delivery element is constructed to deliver a metered dose of fluid from the reservoir onto the porous sample collection media in the coupled position. Thus, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the Beck airflow path as required by claim 23 for the reasons given above for claim 1.
With respect to claim 35, Beck does not teach that the eluent delivery element has a second reservoir containing a fluid that is sealed by a second membrane. Figures 2-3 and paragraph [0043] of Engbersen teach a second reservoir containing a fluid having an opening (55) that is sealed by a second membrane (65) for fluids/additives. It would have been obvious to one of ordinary skill in the art at the time the application was filed to use an eluent delivery device having a second reservoir containing a fluid that is sealed by a second membrane as taught by Engbersen in the Beck device because of the ability to provide additive and/or additional fluids as taught by Engbersen.
With respect to claims 38-40, paragraphs [0011], [0041] and [0054] of Beck teach (also see claims 1, 4 and 7) that the porous sample collection media (the filter membrane) is nonwoven material made from polylactic acid, polypropylene, or a combination thereof and is preferably electrostatic (carries an electrostatic charge).
With respect to claim 42, Beck teaches a method of using the above described device including breathing into the proximal end of the airflow path to collect a sample on the porous sample collection media (see figure 2 with its description in paragraphs [0047]-[0053]) and collecting an eluent from the porous sample collection media (see figure 3 and its associated description in paragraphs [0054]-[0057)]). Beck does not teach coupling the coupling end of the eluent delivery element with the proximal end of the airflow path; and transferring a metered dose of the eluent from the reservoir onto the porous sample collection media to elute the collected sample from the porous sample collection media. These steps are inherent in the use of the Engbersen fluid reservoir device so that claim 42 would have been obvious over the teachings of Beck in view of Engbersen for the reason given above for claim 1.
Claims 4, 20-22, 28, 30-31 and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the art of record fails to teach or fairly suggest the additional limitations in combination with the limitations of the claims from which they depend.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additionally cited art relates to different sample collections structures as well as relevant fluid/liquid release structures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arlen Soderquist whose telephone number is (571)272-1265. The examiner can normally be reached 1st week Monday-Thursday, 2nd week Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571)272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARLEN SODERQUIST/Primary Examiner, Art Unit 1797
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