DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amendment Entered
In response to the amendment filed on 11/11/2025, amended claims 1, 4, 11, 12, 20 and 22 are entered, and claims 19 and 21 are cancelled. Claims 1 –18, 20, and 22 remain pending in the application.
Response to Amendment
Applicant’s remarks and amendments with respect to the drawings, specification and claims have been fully considered and overcome each and every objection and rejection under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed on 08/12/2025. The objections and rejections are withdrawn in view of amendments to the drawings (specifically Replacement Fig. 1), amendments to the specification (specifically amended [0053] and [0086]), amendments to the claims, and arguments regarding support in the specification provided for “a soft tip covering an opening at the second end of the tubing”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
Claims 1-3, 5-10, 12-15 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0375183 A1 to Chen et al. (“Chen”) in view of US 2020/0196994 A1 to Fougere.
Regarding independent claim 1, Chen discloses a saliva collection container (see Figs. 2-4, [0048] and [0051], “…container collects liquid (e.g., saliva)…liquid container 14…”) comprising:
a removable cartridge containing an absorbent material adapted to absorb liquid (see Figs. 6-7 and [0055], “…an absorbent insert, generally indicated at reference numeral 70, is receivable in the interior space 34 of the container body 30… absorbent insert 70 includes…an absorbent core 88…first and second body portions 30A, 30B may also be separated to remove/replace the absorbent insert”, absorbent insert 70 is removable from body portions 30A and 30B of liquid container 14 (i.e., a removable cartridge) and includes an absorbent core 88. see also [0013], “…absorbent core may comprise an absorbent material configured to absorb liquid introduced into the container”, absorbent core 88 absorbs liquid (i.e., an absorbent material)) the removable cartridge adapted to receive saliva from a user (see Figs. 6-7 and [0055], “…. absorbent insert 70 is configured to absorb liquid (e.g., saliva) aspirated into the container 14 during use…”, insert 70 (i.e., removable cartridge) receives saliva deposited by a user into liquid container 14);
a suction source fluidly coupled to the removable cartridge (see Figs. 1A, 2, and [0049] “…container 14, in turn, is fluidly connected to a source of negative-pressure 20 (i.e., a negative-pressure generator) via a downstream conduit 22…for fluidly connecting the container to the negative-pressure generator…”. see also [0062], “…the absorbent insert 70 are configured to maintain fluid communication between the fluid passageway 60 (and thus the fluid inlet 44) and the fluid outlet 46 within the container body 30 during use…”, negative pressure source 20 (i.e., suction source) is fluidly connected to absorbent insert 70 (i.e., coupled to removable cartridge)), wherein the saliva collection container is adapted to receive the removable cartridge (see Figs. 6-7 and [0055], “…an absorbent insert, generally indicated at reference numeral 70, is receivable in the interior space 34 of the container body 30…”, absorbent insert 70 (i.e., removable cartridge) receivable by liquid container 14 through interior space 34) ; and
tubing having a first end and a second end opposite of the first end (see Figs. 3-4 and [0049], “…fluidly connected to a liquid container…via an upstream conduit 16, which may be a flexible tube…”, see also [0052], “…fluid inlet 44 and fluid outlet 46 comprise male connectors suitable for reception in and connection to fluid tubing…” and [0054], “…fluid passageway 60 fluidly connects the fluid inlet 44 with the interior space 34 of the container body 30… fluid passageway may be a separate conduit extending along the baffle body…inside…the baffle body…axially aligned with the fluid inlet 44 and the fluid outlet 46…”, fluid passageway 60 (i.e., a conduit of flexible tubing extending the length of baffle body 52 of container body 30) extends from opposite ends of container body 30, spanning from fluid outlet 46 (i.e., a first end) to fluid inlet 44 (i.e., a second end), and fluidly connects fluid inlet 44 and fluid outlet 46 with flexible tubing), wherein the first end of the tubing is fluidly coupled to the suction source through an opening in the saliva collection container (see Figs. 3-4 and [0049], “…fluidly connected to a liquid container, generally indicated at 14, via an upstream conduit 16, which may be a flexible tube… a downstream conduit 22, which may be a flexible tube or other device suitable for fluidly connecting the container to the negative-pressure generator…”, fluid inlet 44 (i.e., first end) fluidly connects to negative pressure regulator (i.e., suction source) .
However, Chen fails to disclose “a suction source removably disposed therein and fluidly coupled to the removable cartridge…”.
Chen further discloses a suction source fluidly connected to a liquid collection container, located within a flow path of a liquid collection container (see Fig. 1 and [0049], “…downstream conduit 22, which may be a flexible tube or other device suitable for fluidly connecting the container to the negative-pressure generator…source of negative-pressure 20 comprises a vacuum pump (not shown), or other device, for generating suction to pull a partial vacuum within the oral negative-pressure therapy system…”).
Fougere teaches systems and methods for collecting saliva from an oral cavity of a user (see abstract) including a suction source (see Fig. 1 and [0113], “…Pump 18 begins drawing saliva collected in application tray 16 through tube 33, pump 18, and flow valve 22, with the saliva collecting in saliva collection reservoir 12”), the suction source being removable and disposed within a container (see [0169], “…the pump system is entirely contained in the hand piece…”, see also [0183], “…hand piece houses a disposable waste cartridge…”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the suction source of Chen (to be removably disposed within a saliva collection container) for the purpose of making components easier for a user to replace, as evidence by Fougere (see [0168]). Additionally, one of ordinary skill in the art would have had predictable success combining Chen and Fougere, since their teachings relate to the same narrow field of endeavor, i.e., container devices for saliva collection.
Furthermore, 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 suction source of Chen to be removable from the saliva collection container since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlicnrnan, 168 USPQ 177, 179.
Additionally, Chen fails to explicitly disclose “a tubing having a first end and second end opposite of the first end wherein the first end of the tubing is fluidly coupled to the suction source through an opening in the saliva collection container”.
Chen further discloses flexible tubing fluidly connecting components of a saliva collection container (see [0049], “…fluidly connected to a liquid container, generally indicated at 14, via an upstream conduit 16, which may be a flexible tube… a downstream conduit 22, which may be a flexible tube or other device suitable for fluidly connecting the container to the negative-pressure generator…”) and openings in a saliva collection container used for fluid connections (see [0052], “…fluid inlet 44 and fluid outlet 46 comprise male connectors suitable for reception in and connection to fluid tubing…”).
Chen discloses a suction source fluidly connected to flexible tubing (see Chen [0049]), and inlet/outlet fluid connections located on a saliva collection container housing (see Chen [0052]). The Chen/Fougere combination (as discussed above) teaches a suction source removably disposed in a saliva collection container. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the Chen/Fougere combination (to fluidly connect tubing to a removable suction source) for the purpose of conveying fluid flow through the device, as evidence by Fougere (see [0103]).
Regarding claim 2, the Chen/Fougere combination teaches the saliva collection container of claim 1, as discussed above. The Chen/Fougere combination further teaches wherein the saliva collection container further comprises a mouthpiece fluidly coupled to the second end of the tubing (see Chen Figs. 1A-1C and [0049], “…oral appliance 12…is fluidly connected to a liquid container…via an upstream conduit 16…”, oral appliance 12 (i.e., mouthpiece) is fluidly connected to fluid inlet 44 of fluid passageway 60 (i.e., second end of the tubing of the Chen/Fougere combination, as described above) with flexible tubing, via conduit 16.
Regarding claim 3, the Chen/Fougere combination teaches the saliva collection container of claim 2/1, as discussed above. The Chen/Fougere combination further teaches wherein the mouthpiece comprising an opening through which the saliva may be selectively drawn into the tubing (see Chen Figs. 1A-1C and [0049], “…oral appliance 12…is fluidly connected to a liquid container…” see also [0050], “…oral appliance 12 includes a mouth piece 24 for connecting the oral appliance to the mouth of the user, and an inlet component 26 defining a fluid inlet 28 configured to be disposed in the oral cavity, in fluid communication therewith…”, mouthpiece has a fluid inlet 28 fluidly connected to flexible tubing (i.e., mouthpiece comprises an opening, fluidly coupled to tubing)) and further teaches selective user control of saliva drawing (see Chen Figs. 1A-1C and [0049], “…source of negative-pressure 20 may include a user interface for controlling the operation of the vacuum pump”, user control of drawing of saliva).
However, the Chen/Fougere combination fails to disclose “wherein the mouthpiece is a self- sealing bite-actuated mouthpiece comprising a sealable opening through which the saliva may be selectively drawn into the tubing…”.
Fougere further teaches a self- sealing bite-actuated mouthpiece in which biting down on the mouthpiece initiates saliva collection (see Fougere [0112], “…user positions application tray 16 in the oral cavity about the teeth and gingival area. The user closes down on tray 16, thereby achieving an effective fit or seal between gums, teeth and tray 16. In use of the system according to the invention, the user bites down on the mouthpiece, activating the switch in the mouthpiece to initiate the system…”, see also [0113], “…activated when the user bites down on mouthpiece 16…valve 24 is closed, while flow valve 22 is opened. Pump 18 begins drawing saliva collected in application tray 16 through tube 33…”, in response to the user biting down on the mouthpiece, mouthpiece is sealed between gums of a user (i.e., mouthpiece seals) and saliva collection is initiated (i.e., self-sealing and bite actuated). During saliva collection, valve 22 (i.e., a sealable opening) opens to draw saliva to collection reservoir 12 through tubing 33).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the mouthpiece of the Chen/Fougere combination (to be self-sealing, bite-actuated, and have a sealable opening) for the purpose of minimizing leakage of the collection device during operation, as evidence by Fougere (see [0152]).
Additionally, the Chen/Fougere combination fails to disclose “…wherein the mouthpiece is selectively configured between a closed configuration, in which the mouthpiece is adapted to prevent saliva from being drawn therethrough, and a drawing configuration, in which the mouthpiece is adapted to permit saliva to be drawn therethrough via the suction source, wherein the mouthpiece is adapted to be configured from the closed configuration to the drawing configuration responsive to compressive forces applied thereto…”.
Fougere further teaches selective activation of saliva collection as a result of a user biting down on a mouthpiece (see [0112]-[0113], “…user positions application tray 16 in the oral cavity…user closes down on tray 16, thereby achieving an effective fit or seal between gums, teeth and tray 16…user bites down on the mouthpiece, activating the switch in the mouthpiece to initiate the system…”) and sealing a mouthpiece with compressive forces (see Fougere [0152], “…the gingival seal is created by the frictional engagement and compression of an elastomeric material with the gingival…”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the mouthpiece of the Chen/Fougere combination (to selectively configure between a closed configuration, in which the mouthpiece prevents saliva from being drawn therethrough, and a drawing configuration, in which the mouthpiece permits saliva to be drawn therethrough via the suction source (of the Chen/Fougere combination) in response to compressive forces) for the purpose of improving the consistency of fluid collection and delivery, as evidence by Fougere (see [0060]).
Additionally, the Chen/Fougere combination fails to disclose “…and further wherein the mouthpiece is biased to automatically return from the drawing configuration to the closed configuration”.
Fougere further teaches a bite actuated mouthpiece collecting saliva and automatically stopping saliva collection after a period of time (see Fougere [0065], “…when the user first bites down on the mouthpiece…activates the collection of saliva from the oral cavity… After a set time, the collection of saliva is halted…”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the mouthpiece of the Chen/Fougere combination (to automatically return from the drawing configuration to the closed configuration) for the purpose of verifying the collection device is properly positioned prior to saliva collection and operation, as evidence by Fougere (see [0091]).
Regarding claim 5, the Chen/Fougere combination teaches the saliva collection container of claim 2/1, as discussed above. The Chen/Fougere combination further teaches wherein the mouthpiece comprises an opening (see Chen [0050], “…oral appliance 12 includes a mouth piece 24 for connecting the oral appliance to the mouth of the user, and an inlet component 26 defining a fluid inlet 28 configured to be disposed in the oral cavity…”inlet component (i.e., opening)).
However, the Chen/Fougere combination fails to explicitly disclose “wherein the mouthpiece comprises two or more openings”.
Fougere further teaches a mouthpiece with a plurality of openings (see Fig. 3 and [0146]“…Inner front wall jet slots 132 are located on inner front wall 116, while inner back wall jet slots 134 are located on inner back wall 118”, jet slots interpreted as two or more openings).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the mouthpiece of the Chen/Fougere combination (to include two or more openings) for the purpose of conveying fluid flow through the device, as evidence by Fougere (see [0103]).
Regarding claim 6, the Chen/Fougere combination teaches the saliva collection container of claim 2/1, as discussed above.
However, the Chen/Fougere combination fails to disclose “wherein the mouthpiece is rounded”.
Fougere further teaches a curved mouthpiece (see Fougere Figs. 3-4 and [0166], “…contact area provides a radial and or curved smooth surface to provide point of contact and a comfortable sealing…”, curved smooth surface of mouthpiece (i.e., rounded mouthpiece)).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the mouthpiece of the Chen/Fougere combination (to be rounded) for the purpose of providing comfortable sealing for the user, as evidence by Fougere (see [0166]).
Regarding claim 7, the Chen/Fougere combination teaches the saliva collection container of claim 2/1, as discussed above. In an alternate embodiment, Chen further teaches filters inside a liquid collection container (see Chen Fig. 26 [0069], “…one or more filters. A first filter 98A is placed within the interior space 34 of the container body 30 adjacent the fluid outlet 46. A second filter 98B is placed between the fluid outlet 46 and the downstream conduit 22 leading to the source of negative pressure 20…third filter 98C is placed within the downstream conduit 22”).
However, the Chen/Fougere combination fails to disclose “wherein the mouthpiece comprises a filter”.
Fougere further teaches (see Fougere [0106], “…Application tray 16…connected to system 10 by way of tubes 31, 33…could be one or two sided with internally, easily cleanable filters..”, internal filters contained in a mouthpiece).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the mouthpiece of the Chen/Fougere combination (to comprise a filter) for the purpose of trapping particles and providing easier cleaning for the user, as evidence by Fougere (see [0106]).
Regarding claim 8, the Chen/Fougere combination teaches the saliva collection container of claim 1, as discussed above. The Chen/Fougere combination further teaches a conduit directing fluid flow from an inlet to an outlet that are axially aligned (see Chen [0054], “…fluid passageway 60 extends from the connected first end through the free second end… axially aligned with the fluid inlet 44 and the fluid outlet 46…”, axial alignment of conduit (i.e., fluid passageway 60) between fluid inlet and outlet, indicates a uniform diameter of fluid passageway between fluid inlet and fluid outlet), and further teaches flexible tubing as a conduit (see Chen [0049], “…upstream conduit 16, which may be a flexible tube or other device suitable for fluidly connecting the oral appliance to the container…”).
However, the Chen/Fougere combination is silent regarding “wherein the tubing has an inside diameter, wherein the inside diameter is constant throughout the tubing”.
Chen discloses a fluid conduit comprising flexible tubing for conveying liquid (see Fig. 3 and [0049]). Although Chen does not explicitly disclose tubing having an inside diameter, the flexible tubing necessarily possesses an inside diameter as a necessary structural property of a cylindrical tube. The selection of an inside diameter to couple with structural components of accommodate a desired flow rate would have been a matter of routine optimization, as the relationship between an inside diameter of a tube and fluid transport is well known in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tubing of the Chen/Fougere combination (to have an inside diameter), since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 9, the Chen/Fougere combination teaches the saliva collection container of claim 1, as discussed above. Chen further discloses a vacuum pump generating suction (see Chen [0049], “…source of negative-pressure 20 comprises a vacuum pump (not shown), or other device, for generating suction…”).
The Chen/Fougere combination fails to disclose “wherein the suction source comprises a motor”.
Fougere further teaches a motor driven system (see Fougere [0184], “…liquid system may be driven by a rotary motor…”, liquid delivery driven by a motor).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the suction source of the Chen/Fougere combination (to be motor driven) for the purpose of controlling liquid movement through the system, as evidence by Fougere (see [0184]).
Regarding claim 10, the Chen/Fougere combination teaches the saliva collection container of claim 1, as discussed above. The Chen/Fougere combination further teaches a liquid collection container with removably attachable body portions (see Chen [0057], “…first and second body portions 30A, 30B may also be separated to remove/replace the absorbent insert…”) and replaceable components (see Chen [0048], “…absorbent insert is replaceable so that a spent absorbent insert can be replaced with a new, fresh absorbent insert…”).
However, the Chen/Fougere combination fails to explicitly disclose “wherein the saliva collection container is disposable”.
Fougere further teaches a saliva collection system with replaceable and disposable components (see Fougere [0168], “…components may also be disposable and replaceable by nature (refill cartridges, etc.), thus modular and easily replaced by the user…”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the collection container of the Chen/Fougere combination (to be disposable) for the purpose of easy replacement by a user, as evidence by Fougere (see [0168]).
Regarding claim 12, the Chen/Fougere combination teaches the saliva collection container of claim 1, as discussed above.
However, the Chen/Fougere combination fails to disclose “wherein the liquid absorbent material adapted to absorb liquid comprises an odor reducing agent”.
Fougere further teaches halitosis reducing agent additives (see [0079], “…adding a antibacterial, halitosis reducing agent…, and/or any combination of these or other additives…”, halitosis reducing agent (i.e., breath odor reducing agent)).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the liquid absorbent material of the Chen/Fougere combination (to comprise an odor reducing agent) for the purpose of automatic treating of an oral condition of a user, as evidence by Fougere (see [0079]).
Regarding claim 13, Chen/Fougere combination teaches the saliva collection container of claim 12/1, as discussed above. The Chen/Fougere combination further teaches wherein the odor reducing agent is baking soda, an anti-bacterial agent, or an essential oil (see Fougere [0079], “…adding a antibacterial…”, see also Fougere [0045], “…liquid may comprise an antimicrobial composition comprising (a) an antimicrobial effective amount of thymol and one or more other essential oils…”, i.e., antibacterial agent, essential oils).
Regarding claim 14, the Chen/Fougere combination teaches the saliva collection container of claim 1, as discussed above. The Chen/Fougere combination further teaches wherein the suction source can be regulated to different strengths of suctioning (see Chen [0049], “…source of negative-pressure 20 comprises a vacuum pump (not shown), or other device, for generating suction to pull a partial vacuum within the oral negative-pressure therapy system 10…include a user interface for controlling the operation of the vacuum pump…include a controller (e.g., a microcontroller) for operating the vacuum pump”, suction source (of the Chen/Fougere combination) operation is controlled by a user (i.e., regulated suctioning power)).
Regarding claim 15, the Chen/Fougere combination teaches the saliva collection container of claim 1, as discussed above. The Chen/Fougere combination further teaches liquid container materials formed of rigid plastic formed by injection molding (see Chen [0051], “…container body 30 may be formed from generally rigid plastic, such as polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), or other material…the container body portions 30A, 30B may be formed by injection molding process…”) and further teaches tubing passing through a body of a saliva collection container (see Chen Figs. 2-3 and [0054], “…fluid passageway 60 fluidly connects the fluid inlet 44 with the interior space 34 of the container body 30… fluid passageway 60…a separate conduit extending along the baffle body…inside…the baffle body…”, tubing of the Chen/Fougere combination (i.e., fluid passageway 60 as flexible conduit) extends through the inside of container body 30).
However, the Chen/Fougere combination is silent regarding “wherein the tubing is not clear”.
Although the Chen/Fougere combination is silent regarding the material and opacity of the flexible tubing, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the tubing of the Chen/Fougere combination (to be not clear) for the purpose of concealing saliva transport through tubing.
Furthermore, modifying the tubing of the Chen/Fougere combination (to be not clear) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding independent claim 22, Chen discloses a saliva collection container (see Figs. 2-4, [0048] and [0051], “…container collects liquid (e.g., saliva)…liquid container 14…”) comprising:
a cartridge containing an absorbent material adapted to absorb liquid (see Figs. 6-7 and [0055], “…an absorbent insert, generally indicated at reference numeral 70, is receivable in the interior space 34 of the container body 30… absorbent insert 70 includes…an absorbent core 88…first and second body portions 30A, 30B may also be separated to remove/replace the absorbent insert”, absorbent insert 70 is disposed in body portions 30A and 30B of liquid container 14 and includes an absorbent core 88. see also [0013], “…absorbent core may comprise an absorbent material configured to absorb liquid introduced into the container”, absorbent core 88 absorbs liquid (i.e., an absorbent material, adapted to absorb liquid)),
the tubing having a first end and second end opposite of the first end (see Figs. 3-4 and [0049], “…fluidly connected to a liquid container…via an upstream conduit 16, which may be a flexible tube…”, see also [0052], “…fluid inlet 44 and fluid outlet 46 comprise male connectors suitable for reception in and connection to fluid tubing…” and [0054], “…fluid passageway 60 fluidly connects the fluid inlet 44 with the interior space 34 of the container body 30… fluid passageway may be a separate conduit extending along the baffle body…inside…the baffle body…axially aligned with the fluid inlet 44 and the fluid outlet 46…”, fluid passageway 60 (i.e., a conduit of flexible tubing extending the length of baffle body 52 of container body 30) extends from opposite ends of container body 30, spanning from fluid outlet 46 (i.e., a first end) to fluid inlet 44 (i.e., a second end), and fluidly connects fluid inlet 44 and fluid outlet 46 with flexible tubing), wherein the first end of the tubing is fluidly coupled to the suction source (see Figs. 3-4 and [0049], “…fluidly connected to a liquid container, generally indicated at 14, via an upstream conduit 16, which may be a flexible tube… a downstream conduit 22, which may be a flexible tube or other device suitable for fluidly connecting the container to the negative-pressure generator…”, fluid inlet 44 (i.e., first end) fluidly connects to negative pressure regulator (i.e., suction source); wherein the tubing is adapted to receive the cartridge (see Figs. 3-4 and [0049], “…fluidly connected to a liquid container…via an upstream conduit 16, which may be a flexible tube…”, see also [0052], “…fluid inlet 44 and fluid outlet 46 comprise male connectors suitable for reception in and connection to fluid tubing…”, connectors at fluid inlet 44 and fluid outlet 46 fluidly couple tubing to liquid storage container 14 (housing absorbent insert 70)); and
the suction source and fluidly coupled to the tubing (see Figs. 1A, 2, and [0049] “…container 14, in turn, is fluidly connected to a source of negative-pressure 20 (i.e., a negative-pressure generator) via a downstream conduit 22…for fluidly connecting the container to the negative-pressure generator…”. see also [0062], “…the absorbent insert 70 are configured to maintain fluid communication between the fluid passageway 60 (and thus the fluid inlet 44) and the fluid outlet 46 within the container body 30 during use…”, negative pressure source 20 (i.e., suction source) is fluidly connected to absorbent insert 70 (i.e., coupled to removable cartridge)).
However, Chen fails to explicitly disclose “a cartridge containing a liquid absorbent material, the cartridge adapted to fit inside a tubing”.
Chen further teaches configuring an absorbent insert to maintain fluid communication between the absorbent material and a fluid passageway (see [0062], “…absorbent insert 70 may be designed and constructed to maintain the flow of gas from the fluid passageway 60, along the first and second fluid paths to the fluid outlet 46 during operation of the system 10”), and one or more filters positioned in flexible tubing of conduits (see [0069], “…filter 98B may also be suitable for interconnecting the fluid outlet 46 of the container 14 and the downstream conduit 22. A third filter 98C is placed within the downstream conduit 22…”).
Chen discloses a cartridge with a liquid absorbent material in fluid contact with tubing, and further teaches in-line filters positioned in tubing (see Chen [0069]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the cartridge containing a liquid absorbent material disclosed by Chen (to fit inside a tubing) for the purpose of maintaining fluid communication between a fluid inlet and a fluid outlet, as evidence by Chen (see [0048]). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to place the cartridge disclosed by Chen inside the flexible tubing, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Additionally, Chen fails to disclose “a suction source removably disposed therein and fluidly coupled to the tubing”.
Chen further discloses a suction source fluidly connected to a liquid collection container, located within a flow path of a liquid collection container (see Fig. 1 and [0049], “…downstream conduit 22, which may be a flexible tube or other device suitable for fluidly connecting the container to the negative-pressure generator…source of negative-pressure 20 comprises a vacuum pump (not shown), or other device, for generating suction to pull a partial vacuum within the oral negative-pressure therapy system…”).
Fougere teaches systems and methods for collecting saliva from an oral cavity of a user (see abstract) including a suction source (see Fig. 1 and [0113], “…Pump 18 begins drawing saliva collected in application tray 16 through tube 33, pump 18, and flow valve 22, with the saliva collecting in saliva collection reservoir 12”), the suction source being removable and disposed within a container (see [0169], “…the pump system is entirely contained in the hand piece…”, see also [0183], “…hand piece houses a disposable waste cartridge…”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the suction source of Chen (to be removably disposed within a saliva collection container) for the purpose of making components easier for a user to replace, as evidence by Fougere (see [0168]). Furthermore, one of ordinary skill in the art would have had predictable success combining Chen and Fougere, since their teachings relate to the same narrow field of endeavor, i.e., container devices for saliva collection.
Claims 4, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Fougere, and further in view of US 2019/0367224 A1 to Campbell et al. (“Campbell”).
Regarding claim 4, the Chen/Fougere combination teaches the saliva collection container of claim 2/1, as discussed above. The Chen/Fougere combination further teaches wherein the mouthpiece comprises an opening at the second end of the tubing (see Chen Figs. 1A-1C and [0049], “…oral appliance 12…is fluidly connected to a liquid container…” see also Chen [0050], “…oral appliance 12 includes a mouth piece 24 for connecting the oral appliance to the mouth of the user, and an inlet component 26 defining a fluid inlet 28 configured to be disposed in the oral cavity, in fluid communication therewith…”, mouthpiece has a fluid inlet 28 fluidly connected to flexible tubing (i.e., mouthpiece comprises an opening, fluidly coupled to tubing)).
However, the Chen/Fougere combination fails to disclose “wherein the mouthpiece comprises a soft tip at the second end of the tubing”.
Campbell teaches a hydration system including flexible tubing fluidly connected to a liquid reservoir and a bite actuated mouthpiece (see Fig. 3 and [0057], “…elongate flexible drink tube 30 fluidly interconnects the liquid reservoir 26 with the bite-actuated mouthpiece 10…”, mouthpiece 10 covers flexible tube 30 (i.e., covers an opening at an end of tubing)) and further teaches a mouthpiece made of resilient material (see [0051], “…Mouthpiece 10, or at least body 34 thereof, may be formed from a resilient material, such as silicone…”, resilient material of silicone interpreted as a “soft” material, see 35 U.S.C. 112(a) and 112(b) rejections above regarding interpretation of “soft” regarding mouthpiece material).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the mouthpiece of the Chen/Fougere combination (to include a soft tip covering an opening at the second end of the tubing) for the purpose of providing suitable contact with a user’s mouth, as evidence by Campbell (see [0051]). Furthermore, one of ordinary skill in the art would have had predictable success combining Chen, Fougere and Campbell, since the teachings each relate to delivering/removing fluids from the mouth of a user, and contain compatible structural features for fluid collection/delivery.
Regarding claim 16, the Chen/Fougere combination teaches the saliva collection container of claim 1, as discussed above.
However, the Chen/Fougere combination fails to disclose “wherein the saliva collection container is housed in a housing unit”.
Campbell teaches a fluidly connected system including liquid reservoir, flexible tubing, a bite actuated mouthpiece, and a pump (see Fig. 3 and [0057], “…hydration system 14, the elongate flexible drink tube 30 fluidly interconnects the liquid reservoir 26 with the bite-actuated mouthpiece 10, optionally via one or more liquid ports or connections… downstream assembly 28 also may include one or more additional components 35, such as (but not limited to)… a pump…”) and further teaches a system carrying structure (see Fig. 3 and [0057], “…hydration system 14 may include, and/or may be configured to be operatively received by, a pack, a body-worn pack, a garment, or other carrying structure, or carrier, 32”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to house the saliva collection container (of the Chen/Fougere combination) in a housing unit for the purpose of storing the collection container, as evidence by Campbell (see [0057]).
Regarding claim 17, the Chen/Fougere/Campbell combination teaches the saliva collection container of claim 16/1, as discussed above. The Chen/Fougere/Campbell combination further teaches wherein the housing unit comprises a carrying mechanism (see Campbell Fig. 3 and [0057], “…hydration system 14 may include, and/or may be configured to be operatively received by, a pack, a body-worn pack, a garment, or other carrying structure, or carrier, 32”, carrying structure, or a body worn pack (i.e., body-worn pack indicative of a mechanism for carrying).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include a carrying mechanism to the housing unit of the Chen/Fougere/Campbell combination, since it has been held that making an old device portable or movable without producing any new and unexpected result involves only routine skill in the art. In re Lindberg, 93 USPQ 23 (CCPA 1952).
Regarding claim 18, the Chen/Fougere/Campbell combination teaches the saliva collection container of claim 17/1, as discussed above. The Chen/Fougere/Campbell combination further teaches a fastening device (see Campbell [0057], “…include one or more additional components 35, such as (but not limited to)… a quick connect assembly… configured to be operatively received by, a pack, a body-worn pack, a garment, or other carrying structure, or carrier, 32”, quick connect assembly (i.e., a fastening device)).
However, the Chen/Fougere/Campbell combination fails to explicitly disclose “wherein the carrying mechanism is a fastening device”.
The Chen/Fougere/Campbell combination teaches a saliva collection container housed in a portable housing unit, and Campbell further teaches fastening mechanism assemblies and operatively receiving carrying structures. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the carrying mechanism of the Chen/Fougere combination (to be a fastening device) for the purpose of selectively connecting system components, as evidence by Campbell (see [0057]).
Furthermore, It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the carrying mechanism of the Chen/Fougere combination (to be a fastening device) since it has been held that the provision of adjustability, where needed, involves routine skill in the art. In re Stevens, 101 USPQ 284 (CCPA 1954).
Regarding claim 20, the Chen/Fougere/Campbell combination teaches the saliva collection container of claim 17/1, as discussed above. The Chen/Fougere/Campbell combination further teaches a pack carrying structure (see Campbell [0057], “…a pack, a body-worn pack, a garment, or other carrying structure, or carrier, 32…”, carrying structure of a pack indicative of an attachment mechanism by which a user can carry).
However, the Chen/Fougere/Campbell combination is silent regarding “wherein the carrying mechanism is a handle, strap, or loop”.
Although the Chen/Fougere/Campbell combination does not explicitly disclose a carrying mechanism of handle a strap or a loop, such modification would involve a mere change in form or shape of the carrying mechanism. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the carrying mechanism of the Chen/Fougere/Campbell combination (to be a handle, strap, or loop) since it has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Fougere, and further in view of US 2018/0355236 A1 to Lumsden et al. (“Lumsden”).
Regarding claim 11, the Chen/Fougere combination teaches the saliva collection container of claim 1, as discussed above. Chen further teaches high absorbency materials (see Chen [0060], “…absorbent core 88 is capable of absorbing and retaining liquid, such as saliva. The absorbent core 88 may comprise hydrophilic fibers and/or a high-absorbency material commonly known as superabsorbent material…”), and Fougere further teaches a liquid vehicle including thickening or gelling agents (see Fougere [0045], “…liquid may comprise an antimicrobial composition…liquid vehicle can be aqueous or non-aqueous, and may include thickening agents or gelling agents to provide the compositions with a particular consistency…”).
However, the Chen/Fougere combination fails to teach “wherein the liquid absorbent material adapted to absorb liquid comprises sodium bentonite”.
Lumsden teaches a liquid additive created by adding a gel forming agent of sodium bentonite to a bead suspension (see [0036], “…water absorbing materials include but are not limited to water swellable clays such as sodium bentonite… added in any amount to achieve the desired properties of the fluid, or the desired amount of lightweight bead suspension and will vary depending on the composition of the fluid and/or the weight and other properties of the lightweight beads”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the liquid absorbent material of the Chen/Fougere combination (to comprise sodium bentonite) for the purpose of absorbing and storing aqueous liquids by forming a gel, as evidence by Lumsden (see [0036]). Furthermore, one of ordinary skill in the art would have had predictable success combining Chen, Fougere and Lumsden since the teachings each relate to absorbative materials.
Response to Arguments
Applicant's arguments filed 11/11/2025 with respect to the rejection of claims 1-18, 20, and 22 under 35 U.S.C. 103 have been fully considered but they are not persuasive, as necessitated by amendments to the claims.
Applicant argues (see pg. 12 of remarks) that Fougere fails to teach or suggest “a suction source removable disposed therein”. Examiner respectfully disagrees Examiner relies on Chen to teach a removable cartridge (see [0055]), and relies on Fougere to teach a removable suction source disposed in a saliva collection cartridge (see Fig. 1 and [0113], [0169] and [0183], pump of saliva collection system is contained in a hand piece containing removable components). Therefore, this line of argument is considered not persuasive in view of the treatment of independent claims 1 and 22 above.
Applicant argues (see pg. 12-13 of remarks) that Chen and Fougere, taken individually or in combination, fail to teach or suggest “a removable cartridge containing a liquid absorbent material, the removable cartridge adapted to receive saliva from a user” as recited in amended claim 1. In particular, applicant argues that the absorbent insert of Chen serves a fundamentally different structure and function than the claimed invention, and further argues that the absorbent pad of Fougere is located in the mouthpiece rather than a removable cartridge .
Examiner respectfully disagrees that Chen fails to teach or suggest the abovementioned limitation, as recited in amended claim 1, for several reasons. First, amended claim 1 recites “a removable cartridge containing an absorbent material adapted to absorb liquid…”. Examiner relies on the teachings of Chen to teach a removable cartridge containing an absorbent material adapted to absorb liquid (see [0013] and [0055], absorbent core 88 absorbs liquid). Second, in response to applicant's argument that the absorbent insert of Chen serves a fundamentally different structure and function than the claimed invention and that Fougere fails to cure the deficiencies of Chen, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant further argues (see pg. 13 of remarks) that Chen, Fougere and Campbell, taken individually or in combination, fail to teach or suggest “wherein the mouthpiece comprises a soft tip covering an opening at the second end of the tubing”. In particular, applicant argues one of ordinary skill in the art would not have been motivated to combine the teachings of Chen, Fougere, and Campbell because the systems of Chen/Fougere and Campbell work in contrast to each other.
Examiner respectfully disagrees that one of ordinary skill in the art would not have been motivated to combine the teachings of Chen. Fougere and Campbell. As discussed above, one of ordinary skill in the art would have had predictable success combining Chen, Fougere and Campbell, since the teachings each relate to delivering/removing fluids from the mouth of a user, and contain compatible structural features for fluid collection/delivery. Therefore, this line of argument is considered not persuasive in view of the treatment of claim 11 above.
Applicant further argues (see pg. 14 of remarks) that Chen, Fougere and Lumsden fail to teach or suggest “ a removable cartridge containing a liquid absorbent material, the removable cartridge adapted to receive saliva from a user”. This argument is considered not persuasive in view of the treatment of claim 11 above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA P NOVAK whose telephone number is (703)756-1947. The examiner can normally be reached M-F: 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791