DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 June 2026 has been entered.
Status of Claims
Claim(s) 1, 12 and 15 is/are currently amended. Claim(s) 1-15 is/are pending.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 1-3, 5-8 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0319239 A1 (previously cited, Tanenaka '23) in view of US 2020/0278275 A1 (previously cited, Turgul) and US 2012/0302907 A1 (previously cited, Palmskog).
Regarding claims 1, 3 and 12, Tanenaka '239 teaches and/or suggests a collecting device for collection of airborne particles from a flow of air (e.g., Fig. 3, collecting device 10), said collecting device comprising:
a first layer (perforated plate 101) and a second layer (collection plate 102, or combination of collection plate 102 and collection plate holder 103), wherein the first layer and the second layer are arranged to be spaced apart for forming a particle collection chamber between the first and second layer (Fig. 3; ¶ [0025] distance between the perforated plate and the collection plate; etc.),
wherein the first layer comprises a plurality of inlets configured to extend through the first layer for transporting the flow of air therethrough into the particle collection chamber (Fig. 3, nozzles 1011),
wherein ends of the inlets are configured to face a first surface of the second layer for capturing airborne particles in the flow of air entering the particle collection chamber through the ends of the inlets by impaction of airborne particles on the first surface of the second layer (Fig. 3; Abstract, the collecting device is impaction-based in which particles and/or micro-organisms are captured by the capture surface of the collection plate; etc.),
wherein the second layer comprises a plurality of outlets configured to extend through the second layer for transporting the flow of air therethrough out of the particle collection chamber (Fig. 3, multiple ring-shaped holes/vents; etc.),
wherein the inlets and outlets are staggered such that the center axes of the inlets are displaced from the center axes of the outlets (see, e.g., Fig. 3; ¶¶ [0072]-[0073] the collection plate surface, rather than holes/vents therein are disposed directly below nozzles 1011),
wherein the collecting device is configured such that the flow of air experiences a pressure drop when passing the collecting device (¶ [0083]), and
wherein the first layer and the second layer spaced apart by a gap in the range of 10-150 μm (e.g., ¶ [0065] optimal distance between the perforated plate 101 and the collection plate 102 depends on the diameter of the nozzles 1011, but it is preferably 1/3 to 15 times the nozzle diameter, which encompasses at least ~17-150 μm for the smallest (50 μm) preferred nozzles).
Tanenaka '239 does not expressly disclose the particle collection chamber of the above-noted embodiment (e.g., Fig. 3) is surrounded by side walls extending between the first layer and the second layer. However, Tanenaka '239 discloses at least one alternate embodiment comprising side walls extending between the first layer and the second layer (e.g., Fig. 9, wall portions 1122; ¶ [0100] wall portions 1122 act as inter-nozzle compartment walls and also as a spacer between the collection plate (i.e., convex portions 1121 thereof) and nozzles 1011), and further expressly discloses all embodiments may be combined with one another (e.g., ¶ [0049]). Accordingly, it would have been obvious to modify the above-noted collecting device of Tanenaka '239 (e.g., Fig. 3) with the particle collection chamber being surrounded by side walls extending between the first layer and the second layer as taught/suggested in alternate collecting device embodiments (e.g., Fig. 9) in order to provide the collection chamber with compartment walls and/or provide/maintain a desired spacing between the first layer and second layer (Tanenaka '239, ¶ [0100]), facilitate supporting the first layer to minimize/reduce warpage thereof (Tanenaka '239, ¶ [0101]), etc.
Tanenaka '239 as modified does not expressly disclose the pressure drop is lower than 3 kPa at a flow rate of 0.5 liters per second, or lower than 1.5 kPa at a flow rate of 0.5 liters per second.
Turgul discloses a comparable device (e.g., Figs. 1-2, etc.) configured to collect exhaled breath and/or particles therein for use in monitoring a physiology of a subject, indicating an airway disease, etc. (e.g., ¶ [0002]; ¶ [0057]; etc.).
Palmskog discloses, to be able to collect exhaled breath samples from most subjects, the pressure drop through the collection system has to be as low as possible, disclosing a pressure drop of less than 2 cmH2O (i.e., approximately 0.196 kPa) at a flow rate of 0.5 liters per second (i.e., exhalation flow rates of up to 9 liters per second) as a suitable pressure drop (¶¶ [0021]-[0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tanenaka '239 with the pressure drop being lower than 3 kPa, or 1.5 kPa, at a flow rate of 0.5 liters per second as taught/suggested by Palmskog in order to facilitate collecting particles and/or microorganisms in air exhaled by a user therethrough, enabling the device to be used in monitoring physiology of a particular subject, indicating an airway disease thereof, etc. (Turgul, ¶ [0002]; ¶ [0057]; etc.).
Regarding claim 2, Tanenaka '239 as modified teaches/suggests a volume of the particle collection chamber is smaller than 30 μl, such as smaller than 20 μl. Specifically, Tanenaka '239 discloses the distance between the perforated plate and the collection plate may be 1/3 to 15 times the diameter of the nozzles (50-200 μm), the first layer may be 5-200 mm in diameter (¶¶ [0025]-[0026]), and the second layer is substantially the same diameter as the first layer (e.g., Fig. 3). Accordingly, Tanenaka '239 as modified teaches/suggests the chamber may be defined by a gap between the first and second layers of, e.g., 0.05 mm (1 x 50 μm inlet diameter), and a radius of, e.g., 10 mm, thereby resulting in a volume of ~15.71 mm3 or μl.
Regarding claim 5, Tanenaka '239 as modified teaches/suggests a smallest dimension of a cross-section of the inlets is in a range of 20-300 μm (e.g., ¶ [0026] it is preferred that the diameter of the nozzles is 50-200 μm).
Regarding claim 6, Tanenaka '239 as modified teaches/suggests a number of inlets is larger than 500 (e.g., ¶ [0026] it is preferred that the nozzles of the perforated plate be 1,000 to 10,000 in number).
Regarding claim 7, Tanenaka '239 as modified teaches/suggests a length of the inlets is in a range of 20-500 μm (e.g., ¶ [0026] it is preferred that the perforated plate is 0.01 to 2 mm in thickness, which encompasses at least 100-500 μm).
Regarding claim 8, Tanenaka '239 as modified teaches/suggests a cross-section of the inlets is circular (e.g., ¶ [0026] it is preferred each inlet is circular).
Regarding claim 13, Tanenaka '239 as modified teaches/suggests the limitations of claim 1, as discussed above, but does not expressly disclose a projection of the inlets onto the first surface of the second layer form a hexagonal arrangement of the inlets surrounding each outlet. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device of Tanenaka '239 with the above-noted inlet/outlet arrangement because Applicant has not disclosed that said arrangement uniquely provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant discloses the alleged advantage(s) of said arrangement may also be realized by, e.g., the projection of the inlets and the outlets forming a plurality of rows, wherein every other row is formed by inlets and every other row is formed by outlets (e.g., pg. 27, lines 12-16). Tanenaka '239 as modified discloses a device commensurate in scope with the alternating rows of inlets and outlets (Fig. 3). Accordingly, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the inlet and outlet arrangement disclosed by Tanenaka '239 as modified because either arrangement reduces lateral wind, permits air to escape the particle collection chamber through an outlet without necessarily passing another adjacent inlet, etc.
Regarding claim 14, Tanenaka '239 as modified teaches/suggests a projection of an inlet onto the first surface of the second layer is configured not to overlap with a closest neighbor outlet (e.g., Fig. 3; ¶¶ [0072]-[0073] where the collection plate surface, rather than the holes or vents therein are disposed directly below the nozzles 1011; ¶ [0073] width of the ring structures of the collection plate 102 may be 2 times the diameter of the nozzles 1011, such that even the smallest preferred diameter nozzle (e.g., ¶ [0026] 50 μm) would be separated from the nearest ring-shaped hole(s) by at least 25 μm).
Regarding claim 15, Tanenaka '239 teaches/suggests a method for collection of airborne particles from a flow of air, said method comprising:
receiving a flow of air onto a first layer (perforated plate 101) of a collecting device (Fig. 3, collecting device 10), wherein the first layer comprises a plurality of inlets extending through the first layer (nozzles 1011) (e.g., ¶ [0055] generating air flows toward perforated plate);
passing the flow of air through the inlets into a particle collection chamber between the first layer and a second layer of the collecting device spaced apart from the first layer (collection plate 102, or combination of collection plate 102 and collection plate holder 103, spaced a distance from the perforated plate) (e.g., ¶ [0055] causing air to flow into and through the nozzles 1011 of the perforated plate 101);
capturing airborne particles in the flow of air entering the particle collection chamber by impaction of airborne particles on a first surface of the second layer (e.g., Abstract, the collecting device is impaction-based in which particles and/or micro-organisms are captured by the capture surface of the collection plate; ¶ [0055] once inside the device 10, the air collides with the capture surface of the collection plate 102 and particles and/or microorganisms therein are captured), wherein ends of the inlets are configured to face the first surface of the second layer (e.g., Fig. 3);
passing the flow of air out of the particle collection chamber through outlets extending through the second layer of the collecting device (¶ [0072] air is directed into the ring-shaped holes);
wherein the inlets and outlets are staggered such that the center axes of the inlets are displaced from the center axes of the outlets (e.g., Fig. 3; ¶¶ [0072]-[0073] where the collection plate surface, rather than holes/vents therein, are disposed directly below the nozzles 1011);
wherein the collecting device is configured such that the flow of air experiences a pressure drop when passing the collecting device (e.g., ¶ [0083]).
Tanenaka '239 does not expressly disclose the particle collection chamber of the above-noted embodiment (e.g., Fig. 3) is surrounded by side walls extending between the first layer and the second layer. However, Tanenaka '239 discloses at least one alternate embodiment comprising side walls extending between the first layer and the second layer (e.g., Fig. 9, wall portions 1122; ¶ [0100] wall portions 1122 act as inter-nozzle compartment walls and also as a spacer between the collection plate (i.e., convex portions 1121 thereof) and nozzles 1011), and further expressly discloses all embodiments may be combined with one another (e.g., ¶ [0049]). Accordingly, it would have been obvious to modify the above-noted collecting device of Tanenaka '239 (e.g., Fig. 3) with the particle collection chamber being surrounded by side walls extending between the first layer and the second layer as taught/suggested in alternate collecting device embodiments (e.g., Fig. 9) in order to provide the collection chamber with compartment walls and/or provide/maintain a desired spacing between the first layer and second layer (Tanenaka '239, ¶ [0100]), facilitate supporting the first layer to minimize/reduce warpage thereof (Tanenaka '239, ¶ [0101]), etc.
Tanenaka '239 as modified does not expressly disclose the pressure drop is lower than 3 kPa at a flow rate of 0.5 liters per second.
Turgul discloses a comparable collecting device (e.g., Figs. 1-2, etc., impactor apparatus 100) and method of user thereof, said method comprising, inter alia, receiving a flow of air onto a first layer (impactor housing portion 106) of the collecting device (e.g., ¶ [0057] aerosol inlet 110 may be connected to a mouthpiece module for receiving exhaled breath from a user), wherein the first layer comprises a plurality of inlets extending through the first layer (plurality of flow constrictions 126) (e.g., ¶ [0055] generating air flows toward perforated plate).
Palmskog discloses, to be able to collect exhaled breath samples from most subjects, the pressure drop through the collection system has to be as low as possible, disclosing a pressure drop of less than 2 cmH2O (i.e., approximately 0.196 kPa) at a flow rate of 0.5 liters per second (i.e., exhalation flow rates of up to 9 liters per second) as a suitable pressure drop (¶¶ [0021]-[0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the method of Tanenaka '239 with the pressure drop being lower than 3 kPa at a flow rate of 0.5 liters per second as taught/suggested by Palmskog in order to facilitate collecting particles/microorganisms in air exhaled by a user therethrough, enabling the device to be used in monitoring physiology of a particular subject, indicating an airway disease thereof, etc. (Turgul, ¶ [0002]; ¶ [0057]; etc.).
Claim(s) 4 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanenaka '239 in view of Turgul and Palmskog as applied to claim(s) 1 above, and further in view of US 2005/0279181 A1 (previously cited, Trakumas).
Regarding claim 4, Tanenaka '239 as modified teaches/suggests the limitations of claim 1, as discussed above, and further discloses the collecting device is configured to provide a pressure drop in a particular range when the collecting device receives a flow of air with a flow rate of 0.5 liters per second (see discussion of claim 1 above). Tanenaka '239 further discloses the device may be configured to collect virus aggregates (e.g., ¶ [0054]), disclosing diameters of virus aggregates contained in air exhaled from an influenza-infected patient are said to be larger than 300 nm, i.e., in the range of 0.5 to 5 μm (i.e., 500-5000 nm) (¶ [0017]), but does not expressly disclose the collecting device is configured to provide a collection efficiency of at least 50% for particles having a diameter larger than 300 nm when the collecting device receives a flow of air with a flow rate of 0.5 liters per second.
Trakumas discloses a comparable collecting device (inertial impactor) may be configured to provide a collection efficiency of at least 50% for particles having a diameter larger than a selected diameter (50% cut-off size, or d50) when the collecting device receives a flow of air with a selected flow rate (e.g., ¶¶ [0018]-[0022]).
Since the device of Tanenaka '239 as modified is configured for providing a pressure drop range at a selected flow rate (e.g., 0.5 liters per second), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tanenaka '239 with the collecting device being further configured (e.g., by inlet nozzle area, jet-to-plate distance, nozzle throat length, etc.) to provide a collection efficiency of at least 50% for particles having a diameter larger than 300 nm when the collecting device receives a flow of air with said flow rate (e.g., with a 50% cut-off size, or d50, of 300 nm, at the selected flow rate, such that collection of particles larger than said d50 (e.g., in the 500-5000 nm range) have a collection efficiency of at least 50%) as taught and/or suggested by Trakumas in order to facilitate efficiently collecting viral aggregates in exhaled breath, particularly for influenza screening, monitoring, etc. (Trakumas, ¶¶ [0018]-[0022]; Tanenaka '239, ¶ [0017]; etc.).
Regarding claim 9, Tanenaka '239 as modified teaches/suggests the limitations of claim 1, as discussed above, but does not disclose the dimensions of the outlets. In particular, Tanenaka '239 as modified does not disclose a smallest dimension of a cross-section of the outlets is in a range of 20-400 μm, such as in a range of 100-300 μm. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device of Tanenaka '239 because Applicant has not disclosed that the claimed outlet size range alone provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, Applicant discloses setting the size and shape of the outlets in relation to the size and shape of the inlets may facilitate a low pressure drop (e.g., pg. 24, line 36 - pg. 25, line 6). However, there is no limitation as to the inlet size in claim 9. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the outlets being of a sufficient size to provide a pressure drop within the desired range as taught/suggested by Tanenaka '239 as modified because either arrangement enables a user to exhale air through the device to facilitate collection of particles and/or micro-organisms therein.
Alternatively/Additionally, Trakumas discloses outlet size is a result-effective variable. In particular, Trakumas teaches/suggests calculating inlet area for a selected cut-off size and flow rate, then finding the appropriate size of exit orifice for the calculated inlet area that provides a desired pressure drop across the collecting device (e.g., ¶ [0012]). Since Tanenaka '239 as modified teaches/suggests the pressure drop of the collecting device is within a particular range for the claimed flow rate as discussed above with respect to claim 1, the claimed outlet size range would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Regarding claim 10, Tanenaka '239 as modified teaches/suggests the limitations of claim 1, as discussed above, but does not expressly disclose a number of outlets is larger than 500. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device of Tanenaka '239 with the number of outlets being larger than 500 because Applicant has not disclosed that the claimed outlet number range alone provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, Applicant discloses the number of outlets used may fit a total flow rate provided into the collecting device from the inlets and an associated pressure drop experienced by the flow of air and/or the number of outlets may be similar to the number of inlets (e.g., pg. 25, line 22 - pg. 26, line 2). However, claim 10 does not require any particular number of inlets. Applicant further discloses the outlets are "preferably small" (pg. 26, lines 3-5) but provides no reasoning (advantage to, purpose for, problem solved by, etc.) for said preference. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with a number of outlets sufficient to provide a pressure drop within the desired range as taught and/or suggested by Tanenaka '239 as modified because either arrangement enables a user to exhale air through the device to facilitate collection of particles and/or microorganisms therein.
Alternatively/Additionally, Trakumas discloses each of outlet size and outlet number are result-effective variables. In particular, Trakumas teaches/suggests calculating inlet area for a selected cut-off size and flow rate, and finding the appropriate size of outlet for the calculated inlet area that provides a desired pressure drop across the collecting device (¶ [0012]), and discloses using more than a single outlet can permit better control over air velocities, Reynolds numbers, and pressure drops to suit a specific operation (¶ [0044]). Since Tanenaka '239 as modified teaches and/or suggests the pressure drop of the collecting device is within a particular range for the claimed flow rate as discussed above with respect to claim 1, the claimed outlet number range would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanenaka '239 in view of Turgul and Palmskog as applied to claim(s) 1 above; or alternatively, over Tanenaka '239 in view of Turgul and Palmskog as applied to claim(s) 1 above, and further in view of US 2016/0223435 A1 (previously cited, Tanenaka '435).
Regarding claim 11, Tanenaka '239 as modified teaches/suggests the limitations of claim 1, as discussed above, but does not expressly disclose the length of the outlets (i.e., thickness of the collection plate 102, or collection plate 102 and holder 103 combined). Specifically, Tanenaka '239 as modified does not disclose a length of the outlets is in a range of 20-500 μm, such as in a range of 100-300 μm. However, Tanenaka '239 discloses the distance between the first and second layers should remain constant (e.g., ¶ [0083]), thereby teaching/suggesting the first and second layers should be at least sufficiently stable to prevent variation in said distance. Since of ordinary skill in the art would readily appreciate the disclosed second layer materials (e.g., ¶ [0027]) having an increased thickness are relatively more stable (e.g., less flexible, prone to bending/warping, etc.) than thinner layers of said material(s), the claimed outlet length range would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Alternatively/Additionally, Tanenaka '435 discloses a comparable device comprising a second layer (114) having an outlet(s) (116) therein, wherein said second layer has a thickness, and/or said outlet(s) has a length, in a range of 20-500 μm (e.g., ¶ [0087] thickness of the collection plate 114 is preferably from 0.1 mm to 10 mm, which encompasses at least 100-500 μm). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tanenaka '239 with a length of the outlets being in a range of 20-500 μm as taught/suggested by Tanenaka '435 as a simple substitution of one suitable second layer thickness, and corresponding outlet length therethrough, for another to yield no more than predictable results. See MPEP 2143(I)(B).
Double Patenting
The nonstatutory double patenting ("NSDP") rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A NSDP rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional NSDP rejection provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a NSDP rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-3, 5-8 and 12-15 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 of co-pending Application No. 18/031,662 (hereinafter "reference application") in view of Tanenaka '239, Turgul and Palmskog.
Claim 1 of the reference application recites each limitation of claims 1, 3 and 12 of the present application with the exception of the collecting device being configured such that the flow of air experiences a pressure drop when passing the collecting device, the pressure drop being lower than 3 kPa, or 1.5 kPa, at a flow rate of 0.5 liters per second, and the first and second layer being spaced apart by a gap in a range of 10-150 μm, or 20-100 μm. However, as discussed with respect to the prior art rejections of record above, Tanenaka '239 discloses impactors arranged as recited in claim 1 of the reference application, wherein the first and second layer being spaced apart by a gap in a range of 10-150 μm or 20-100 μm, experience a pressure drop, and further discloses the particle collection chamber of such impactors may be surrounding by sidewalls extending between the first and second layers. Turgul discloses such devices may be used by a user exhaling into the collecting device via a mouthpiece. Palmskog discloses, in order to permit a user to exhale through a collecting device, the pressure drop should be as low as possible, disclosing a pressure drop of less than 2 cmH2O (~0.196 kPa) at a flow rate of 0.5 liters per second (flow rates of up to 9 liters per second) as a suitable pressure drop. It would have been obvious to modify the device of claim 1 of the reference application with the above-noted particle collection chamber arrangement and the pressure drop in order to maintain a desired spacing between the first and second layers, prevent warping of the first layer, etc. and to facilitate collecting particles/microorganisms in air exhaled by a user through the device for use in monitoring a physiology of a subject, indicating an airway disease, etc.
With respect to claims 2, 5-8 and 13-15 of the present application, claim 1 of the reference application as modified does not expressly recite the claimed features. However, as discussed above with respect to the prior art rejection(s), Tanenaka '239 teaches/suggests these features, such that it would have been obvious to modify the device of claim 1 of the reference application with the features recited in claims 2, 5-8 and 12-15 of the present application in order to configure the collecting device to capture/collect particles and/or microorganisms of a selected size (e.g., virus aggregates) within the exhaled breath.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 4 and 9-10 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 of co-pending Application No. 18/031,662 (hereinafter "reference application") in view of Tanenaka '239, Turgul and Palmskog as applied above, and further in view of Trakumas.
Claim 1 of the reference application as modified does not recite the features of claims 4 and 9-10 of the present application. However, as discussed above with respect to the prior art rejections, there is insufficient evidence of record to suggest the claimed features are any more than a matter of design choice and/or Trakumas teaches and/or suggests said features, such that it similarly would have been obvious to modify claim 1 of the reference application with said features for at least the reasons noted in the prior art rejections above.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 11 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 of co-pending Application No. 18/031,662 (hereinafter "reference application") in view of Tanenaka '239, Turgul and Palmskog as applied above, and further in view of Tanenaka '435.
Claim 1 of the reference application as modified does not recite the features of claim 11 of the present application. However, as discussed above with respect to the prior art rejection(s), Tanenaka '239 and/or Tanenaka '435 teaches/suggests said features, such that it similarly would have been obvious to modify claim 2 of the reference application with said features for at least the reasons noted in the prior art rejections above.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to the double patenting rejections, Applicant "respectfully requests the rejection be held in abeyance until allowable subject matter has been identified; at such time a terminal disclaimer will be filed as appropriate" (Remarks, pg. 7).
As noted in the prior Office action, a request to hold double patenting rejections in abeyance, or a statement that Applicant will address said rejections in the future, is not a complete response to the outstanding NSDP rejections.
With respect to the prior art rejections, Applicant contends, "Takenaka '239 fails to disclose or suggest the Applicant's recited particle collection chamber surrounded by side walls extending between the first layer and the second layer" (Remarks, pg. 8).
The examiner respectfully disagrees. As noted in the rejections of record above, Takenaka '239, Tanenaka '239 discloses at least one alternate embodiment comprising side walls extending between the first layer and the second layer (e.g., Fig. 9, wall portions 1122; ¶ [0100] wall portions 1122 act as inter-nozzle compartment walls and also as a spacer between the collection plate (i.e., convex portions 1121 thereof) and nozzles 1011), and further expressly discloses all embodiments may be combined with one another (e.g., ¶ [0049]). Accordingly, it would have been obvious to modify the above-noted collecting device of Tanenaka '239 (e.g., Fig. 3) with the particle collection chamber being surrounded by side walls extending between the first layer and the second layer as taught/suggested in alternate collecting device embodiments (e.g., Fig. 9) in order to provide the collection chamber with compartment walls and/or provide/maintain a desired spacing between the first layer and second layer (Tanenaka '239, ¶ [0100]), facilitate supporting the first layer to minimize/reduce warpage thereof (Tanenaka '239, ¶ [0101]), etc.
Applicant further contends, "Takenaka '239 also fails to disclose exhaled breath is used for collecting particles, but instead utilizes a fan. Furthermore, as noted in the Declaration of Benjamin Jackson Jones filed herewith, the methodology provided by Takenaka is only suitable if the gap between the inlet plate and outlet plate is sufficiently small. Takenaka fails to provide any motivation or suggestion that the Applicant's recited gap between the first layer and second layer in the range of 10 to 150 um would provide both an improved collection efficiency and an acceptable pressure drop and flow rate for an exhaled breath. Indeed, Takenaka utilizes a fan to move air through the device" (Remarks, pgs. 8-9).
The examiner has made no contention that Takenaka '239 alone discloses exhaled breath is used for collecting particles. Indeed, no pending claim requires the "flow of air" from which airborne particles are collected to be exhaled breath. Takenaka discloses the collecting device may comprise a gap in the recited range, thereby suggesting this gap is "sufficiently small" to be suitable for the methodology provided by Takenaka. However, the additional cited art, specifically Turgul, at the very least suggests the device of Takenaka '239 may additionally or alternatively be useful in receiving exhaled breath from a user for collecting particles therein. Palmskog discloses a suitable pressure drop range associated with devices through which a user exhales. With respect to the pressure drop, the pending claims only require that the collecting device is configured such that the flow of air experiences a pressure drop lower than 3 kPa (or 1.5 kPa) at a flow rate of 0.5 liters per second when passing [through] the collecting device. The pending claims do not specify the particular configuration or structure of the collecting device that results in the claimed pressure drop range (i.e., how this pressure drop is achieved). One of ordinary skill in the art would readily appreciate that the pressure drop across the collecting device may be controlled by various design parameters, such as number and size of inlets, number and size of outlets, etc. (see, e.g., Trakumas, ¶ [0044]). Alternatively stated, there is no evidence of record, or sufficient reasoning provided by Applicant that the cited prior art indicates that the only way to achieve the claimed pressure drop is by providing a larger gap between layers, as Applicant appears to contend (e.g., Declaration, pg. 3, paragraph 14).
Lastly, the examiner notes neither the pending claims nor the specification precludes the use/inclusion of a fan. As noted above, the claims do not limit the "air" to being exhaled breath. Further, while Applicant discloses "the flow of air may be provided directly from exhalation by the human being," Applicant expressly states the invention is not limited to this means of providing the flow of air, but the flow of air may be provided to/through the collecting device "by any component causing a flow of air" (pg. 3, line 28 – pg. 4, line 3). As noted in the prior Office action, means to assist in drawing air through the collection device, such as the fan disclosed by Takenaka '239 (e.g., ¶ [0024]), and the air being exhaled breath are not mutually exclusive. For example, Palmskog discloses a collection device for receiving exhaled breath for collecting particles therein having a pump (17) for facilitating the flow of said breath directly provided by exhalation through a collection device (e.g., Palmskog, ¶ [0072]). Accordingly, even if Takenaka '239 has a fan, this does not preclude the device from being used to, or configured for use in, collect(ing) particles in exhaled breath as suggested in the proposed modification(s).
Applicant further contends, "[By] the Applicant limiting the claims to the relatively small gap of 10-150 μm, the recited claims define a size of the gap making it very difficult to achieve the claimed pressure drop" (Remarks, pg. 10); and since "methods of the prior art" are incapable of accurately estimating the pressure drop of the small gap size recited (and disclosed by Takenaka '239), as indicated in the provided declaration, "there is simply no way of accurately determining the pressure drop of Takenaka" (Remarks, pg. 10). Applicant appears to be contending that, because two established methods (Darcy-Weisbach equation and Borda-Carnot equation or derivatives thereof) are, according to the inventor, not valid for the small gap size claimed (and disclosed by Takenaka '239), the claimed pressure drop at the recited flow rate would not have been obvious. The examiner respectfully disagrees. By the logic provided in the argument, it seems to follow that configuring the claimed collecting device for any particular pressure drop (or range of pressure drops) would be non-obvious, solely because the cited established methods could not accurately estimate said pressure drop. The pending claims are not directed to a method of estimating a pressure drop through a structure, but instead recite a structure having a specific range of a pressure drop at a particular flow rate. The cited prior art at least suggests the collecting device of Takenaka '239 may be suitable for collecting particles in a flow of air exhaled from a subject (e.g., as taught/suggested by Takenaka '239), and the recited range of a pressure drop through the collecting device as claimed is a suitable one for this application (as taught and/or suggested by Palmskog). As noted above, the pending claims do not specify the particular configuration or structure of the collecting device that results in the claimed pressure drop range (i.e., how this pressure drop is achieved), and it is well-known in the art that various factors affect the pressure drop across the device, as noted above. The proposed modification is to adjust these various factors as needed to produce the result desired for a particular application. How an individual assesses the pressure drop as the factors are adjusted does not seem pertinent to whether or not the desired result is obvious. For example, while Applicant contends established mathematical methods are not suitable for estimating the pressure drops, even if true, said equations are not the only means or method of determining a pressure drop. Rather, the prior art of record indicates that a pressure drop can be directly measured (e.g., US 6,431,014 B1 to Liu, Fig. 10; US 2013/0220034 A1 to Peters, ¶ [0076]; etc.).
Applicant further contends, "Since the particle collection chamber is bound by the first layer and the second layer, which are connected to each other via the sidewalls, the particle collection chamber may be removed from the device to allow for analysis of the particles collected therein while being configured to allow a person to breathe into the device to obtain the particles. Takenaka '239 fails to disclose or suggest a particle collection chamber" (Remarks, pg. 12).
The examiner respectfully disagrees that Takenaka '239 fails to disclose/suggest a particle collection chamber as claimed for the reasons discussed above. If Applicant is contending that Takenaka '239 fails to disclose a particle collection chamber that "may be removed from the device to allow for analysis of the particles collected therein," it is noted that this feature is not recited in the rejected claim(s).
Applicant further discloses Takenaka '239 "appears to actually teach away from using such side walls," contending, "Providing a particle collection chamber closing such outer vent would prevent the air flow to be provided in the manner that is explained as essential in Takenaka '239 and the skilled person would therefore not modify Takenaka '239 in such manner" (Remarks, pg. 12).
The examiner respectfully disagrees. Takenaka '239 does not describe the outer vent as essential, as Applicant alleges. Rather, Takenaka '239 appears to disclose at least one embodiment in which no such outer vent is included (see, e.g., Fig. 3, where the arrows indicative of air flow do not illustrate air flow beyond the outer edge of the collection plate). Further, Takenaka '239 expressly discloses a collection device may include a collection chamber having side walls (e.g., Fig. 9, 1122) that function as spacers between the first layer (perforated plate 101 having nozzles 1011) and the second layer (collection plate 102) (e.g., ¶¶ [0100]-[0101]).
With respect to the rejection(s) of claims 4 and 9-10, Applicant contends Trakumas recites features "in contrast the present claims" (Remarks, pgs. 13). However, the features of Trakumas cited by Applicant neither appear to be relied upon in the rejection(s) of record, nor appear to suggest the proposed modification(s) would not be obvious.
Lastly, with respect to the rejection of claim 11, Applicant contends Takenaka '435 fails to cure the defects in Takenaka '239 in view of Turgul and Palmskog (Remarks, pgs. 13-14). The examiner respectfully disagrees for at least the reasons discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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