DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/17/2026 has been entered.
Response to Amendment
Applicant’s amendments filed 04/17/26 have been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner notes that the applicant argues that the prior art rejection provided in the previous office action fails to teach technical features a-d, provided in the remarks (04/17/26) page 7.
Regarding A), the examiner notes the previous office action responded to the argue. To reiterate, while the examiner agrees with the argument that Tanaka nor Fujisaki teach the system being used for chest draining, an updated rejection in view of both the MPEP and Durkin was provided to show that the there is no specific structure requiring chest drainage, rather just a “chest drainage tube”, where Tanaka discloses a drainage tube connected to the container, where fluid is pulled through the tube through suction. As such it was interpreted that under MPEP Section 2114, Tanaka reads to the claimed invention. The examiner further provided Durkin to show that suction tubing for drainage devices may connect for both urine or chest drainage due based on a patient interfacing device connecting to the tubing, it would have been obvious to one having ordinary skill in the art to connect a chest drainage interface with the suction tubing of Tanaka. The applicant argues that Durkin does not allow for the conversion of urine collecting devices to in-body chest drainage, but as detailed above, 1) there is no structure in the claims specific to chest drainage, and 2) Durkin teaches that suction tubing (such as that provided in Tanaka) may be provided with different connects to patient interfacing devices to allow for drainage in different locations.
Regarding B) the examiner notes that said argue was previously presented and responded to in the 01/23/26 office action. The examiner upholds the combination of Tanaka and Fujisaki in that Fujisaki teaches that piezoelectric pumps are suitable for liquid suction and thus the combination is obvious. The examiner notes that as detailed under the response to argument a) the device of the prior art would be capable of drainage from a chest through said suction, where Fujisaki teaches that a piezoelectric pump is a suitable suction pump to be used for exudate drainage.
Regarding C) the argument is moot as the amendment changes the scope of the claim. The
examiner notes that while the argument regarding the mass sensor is persuasive and thus said mass sensor is not interpreted to be the level sensor, the float device of Tanaka is still interpreted as a liquid level sensor as it directly determines at least a level of liquid in the container. Per para. 0034 of Tanaka, a float part (231d) is configured to move up and down together with a fluctuation of urine level, and thus is interpreted to be a level sensor. The color sensor limitation is addressed in the claim 1 rejection below in view of Justice et al. US 2021/0379269, previously made of record but not applied to a rejection.
Regarding D) the applicant argues that the device of Tanaka does not have the tube extending from a front side surface of the main body to allow for connection to the container upon mounting. The examiner respectfully disagrees. As seen in figure 1A (L) can be seen as the lid of the device, where (23) having ports (23a, 23b) is seen to be the container. As seen in figures 2 and later 3, the tubing extends through (L) and connects to, and through, the ports 23a and 23b. The examiner notes that this extension would be done through L and thus through the concaving open space of Tanaka, best seen in figure 1. This concave space is interpreted to be the front surface of Tanaka, and it is clear that said tubing of the device through said front surface allows for the container to connect to the main body. Thus Tanaka as previously provided reads to the claimed limitation. The examiner notes that applicant argues that the instant configuration (page 9 of remarks) allows the chest drainage bottle to be directly connect to the collecting end when mounted. The examiner notes that the configuration of Tanaka also allows for the bottle to be directly connected to the collecting end when mounted and thus further reads to the claimed limitation.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. US 2008/0004576, hereafter Tanaka, in view of Fujisaki et al. US 2017/0112974, hereafter Fujisaki and further in view of Durkin et al. US 2007/0241119, hereafter Durkin, and further in view of Justice et al. US 2021/0379269, hereafter Justice, where Justice was previously made of record.
Regarding Claim 1, Tanaka discloses
A drainage bottle system (figure 1A), comprising: a system housing having a drainage element disposing space (figure 1B, main body (3)); a drainage bottle (collection container (2)), mounted on the system housing (where said bottle can be seen mounted on the housing in figure 1a, see also para. 0037, with container support part (42) for accommodating the container); a drainage tube (figure 3, tube (T)), which is disposed within the system housing, having a sucking end extending outside the system housing and a collecting end connected to the drainage bottle through the system housing (para. 0044, 0047, where Tube T is a component of the main body and connects externally to the patient (figure 5) at one end, and into the bottle at the second end, see figure 3); and a liquid detection device (figure (3), suction stop means 231, including float part (231d) and ball part (231b)), disposed in the drainage element disposing space and corresponding to the drainage bottle to obtain at least one piece of liquid detection information about the liquid to be detected (para. 0034,0035). The examiner notes that per para. 0034-0035, the suction stop means is indicative of the fluid level as when the fluid level increases, the float is pushed upward and seals the suction inlet thus indicating a full volume of the container. Further, per paragraph 0034, the float part moves up and down with the fluctuation in liquid level and thus is further interpreted to be a level sensor.
While Tanaka discloses the use of a suction pump (abstract), where said pump has a driving signal for operation (para. 0078, 0091), and further discloses where the pump is not limited so long as the pump can suck air (suction) (para. 0073), there is no specific disclosure of a piezoelectric pump being used.
Fujisaki teaches a suction system and is thus considered analogous to the claimed invention. Fujisaki teaches that suction is brought into the system via the driving of a piezoelectric pump (abstract, where para. 0024 further details the pump). Per para. 0024, the piezoelectric pump includes a piezoelectric element and a vibration plate where the pump expands and contracts to deform the plate and allow suction to occur. See also para. 0050. Therefore, as Fujisaki teaches that piezoelectric pumps are suitable suction pumps for fluid suction systems, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a piezoelectric pump as a suitable pump for Tanaka.
The examiner notes that per the disclosure of Tanaka, the pump is within the main body (para. 0009), operates via a drive signal (para. 0078, 0091) to provide suction to the container drawing liquid through (para. 0009) and upon combination with Fujisaki the pump would be a piezoelectric pump, thus reading to the claimed limitation.
The examiner notes that per the amendments filed 12/23/25 the limitation of claim 2 was added into claim 1, as detailed under the response to arguments Tanaka teaches this limitation. The rejection of said limitation is as follows. Tanaka teaches wherein the system housing is provided with a front outer surface as a drainage bottle mounting surface on which the drainage bottle is mounted (Tanaka figure 1b, container support part (42) and accommodating concave portion (43a), where the container can be seen fitting within said portions in figure 1a)), wherein the collecting end of the drainage tube extends through the drainage element disposing space to the drainage bottle mounting surface to be connected to the drainage bottle (Tanaka para. 0044, 0047, where Tube T is a component of the main body and connects externally to the patient (figure 5) at one end, through the main lid portion (0046) and into the bottle at the second end, through bottle inlet (23a) see figure 3).
Additionally, per the amendments filed 12/23/25, the device is configured to be used for chest drainage, where applicant argues that the device of Tanaka is used for urine drainage. While the examiner agrees with this statement, the examiner notes that for suction to be provided to the user, the only connection is through a generic tubing T, as the tubing merely acts as a conduit between the container and the receiver (see Tanaka para. 0092). The examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Tanaka teaches a fluid drainage device, where the device includes a container connected to an external interface on a patient through a tubing, and the claimed limitation nor figures of the application requires no specific chest interfacing apparatus, the application to chest drainage is interpreted to be functional language. As such the device of Tanaka, having the required structural limitations as the claimed invention reads to the claimed device.
Should applicant disagree, the examiner provides a rejection in view of Durkin.
Durkin teaches a fluid drainage device and is thus considered analogous to the claimed invention. Durkin teaches that the device provides suction (para. 0088) for removing a fluid from a space, where the application may be to drain from a chest region or from a bladder region (para. 0035). The device further connects to a receptacle for the fluid (para. 0031), through a tube (6) per figure 1. The other end is provided with a connector (2) for connecting in a sealed manner catheter or drain tube (para. 0099). Therefore as Durkin teaches a suction draining system where the system connects to a receptacle via a tube, and at the other end may be connected to a patient interfacing device for drainage, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the system of Tanaka with barb at the end of the tube (T) to allow for connection to a variety of drainage devices to allow for multiple applications, such as chest and urine, taught by Durkin. Doing so would merely involve the use of known technique (connector on a tubing for a drainage device, where said device can drain from various places such as the chest or bladder) to improve similar devices (urine drainage device comprising a tube for connecting to a patient interface) in the same way, while achieving the predictable result of allowing the device to connect with different patient interfacing devices, thus allowing for further range of applications. As such a prima facie case of obviousness exists.
Upon the amendments filed 04/17/26, the examiner notes that the float part (231d) as detailed above under the same rejection of claim 1, is interpreted to be the liquid level sensor, sensing a level of liquid in the container. However, Tanaka, Fujisaki, nor Durkin teach a liquid color sensor for sensing a liquid color of the liquid in the bottle.
Justice discloses a fluid collection device and is thus considered analogous to the claimed invention. Justice teaches that the system may include monitoring of various fluids, including urine, blood, and more (para. 0034). Justice teaches that the system may incorporate exemplary sensors to further monitor the system, where said sensors may include tilt sensors, temperature sensors, and optical sensors, e.g. to measure color (para. 0051). Per para. 0053, information detected by the sensors is analyzed and may be used to alert a clinician. The examiner notes that therefore as fluid collection containers are known in the art to employ various sensors for data analysis, including fluid color sensors, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the prior art device of Tanaka with a color sensor, to further aid in monitoring and analyzing of the collected fluid. Doing so would merely be combining prior art (fluid collection container with a color sensor) elements according to known methods (taught by Justice) to yield predictable results (that being monitoring of data within the container) and as such a prima facie case of obviousness exists.
Regarding Claim 3, Tanaka, Fujisaki, Durkin, and Justice teach
The chest drainage bottle system as claimed in claim 1, wherein the motorless suction device further includes a suction tube (Tanaka figure 2,3 air flow passage (414) seen with passage forming member (414d) in figure 3), , one end of the suction tube is connected to the piezoelectric suction pump (Tanaka para. 0052), the other end of the suction tube extends to the drainage bottle mounting surface to be connected to the drainage bottle (Tanaka figure 3, para. 0052), and thereby the piezoelectric suction pump is connected to the drainage tube via the suction tube and the drainage bottle, wherein the piezoelectric suction pump is configured to generate the negative pressure in the drainage bottle so that the liquid to be detected is sucked and collected into the drainage bottle via the drainage tube (Tanaka para. 0073, 0078, 0091.) The examiner notes that per the 0073,0078, and 0091 citations, Tanaka provides suction to draw fluid through the device (through air passage (414) para. 0039) into the container for collecting urine. As per the rejection of claim 1, it was found obvious to use a piezoelectric pump as the pump of Tanaka and thus Tanaka in view of Fujisaki reads to the limitations of claim 3.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka in view of Fujisaki, Durkin, and Justice, and further in view of Johnson et al. US 3107630, hereafter Johnson.
Regarding Claim 4, Tanaka, Fujisaki, Durkin, and Justice teach the chest drainage bottle system as claimed in claim 1, wherein the piezoelectric suction pump is a piezoelectric suction pump that utilizes mechanical deformation of a piezoelectric ceramic of the ceramic piezoelectric suction pump to generate the negative pressure. The examiner notes that as detailed under the rejection of claim 1, Fujisaki teaches that the piezoelectric pump includes a piezoelectric element and a vibration plate where the pump expands and contracts to deform the plate and allow suction to occur (para. 0024 of Fujisaki). Thus the pump operates to create suction by mechanical deformation. However, Fujisaki fails to teach that the plate is ceramic.
Johnson teaches a pump system and is thus considered analogous to the claimed invention. Johnson teaches that the pump used is a piezoelectric pump, where the pump comprises plates to function as a diaphragm (bender assembly for deforming) (column 2, lines 13-35). Said assembly is formed of discs or plates including a ceramic material for turning electric fields into mechanical strain. The examiner notes that as detailed above (para. 0024 of Fujisaki) Fujisaki functions in the same manner of turning electric current into mechanical deformation of the plate. Therefore as Johnson teaches that piezoelectric pumps comprising deformable plates may use ceramic as the material for the plates, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use ceramic as the deformable plate of the piezoelectric pump of Tanaka and Fujisaki.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka in view of Fujisaki, Durkin, and Justice, and further in view of Allen et al. CN 104470551, hereafter Allen.
Regarding Claim 5, Tanaka, Fujisaki, Durkin, and Justice teach the chest drainage bottle system as claimed in claim 1, wherein the driving circuit is configured to drive the piezoelectric suction pump (see rejection of claim 1, Tanaka para. 0078,0091). However, there is no disclosure that said signal is a sinusoidal wave signal or a square wave signal.
Allen teaches a negative pressure system and is thus considered analogous to the claimed invention. Allen teaches that the signal supplying power to the pump suction may be a square wave or a sinusoidal wave (para. 0351). Allen also provides examples of the device being actuated by such signals, see para. 0362 and para 0045, where the drive signal includes a square wave. Allen also teaches that the pump may include a piezoelectric diaphragm pump (para. 0371). Therefore, as Allen teaches that piezoelectric suction pumps may be actuated by sine or square waves to provide negative pressure, it would have been obvious to one having ordinary skill in the art to use a sine or square wave as the drive signal of Tanaka to actuate the pump.
Claim(s) 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka in view of Fujisaki, Durkin, and Justice, and further in view of Chang et al. US 2017/0173232, hereafter Chang.
Regarding Claim 6, Tanaka, Fujisaki, Durkin, and Justice teach the chest drainage bottle system as claimed in claim 1, but fails to teach wherein the liquid detection device includes a tag image recognition sensor, wherein the tag image recognition sensor is used for correspondingly sensing a tag identification code of the chest drainage bottle to obtain tag identification information as the liquid detection information.
Chang teaches a fluid (breast milk) collection system and is thus considered analogous to the claimed invention. Chang teaches that the container of the device my include a passive sensor (358 in figure 34) such as an RFID device that is recognizable by the controller of external computer of the system (para. 0276, 0288). Said sensor allows the container to link the specific container to all data recorded by it (para. 0276). To read the RFID on the container, the controller and/or external device of the system include a reading application (para. 0288), or a scanner (para. 0273). Therefore, as a means to track a container and determine data associated with fluid collected by the specific container, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the container and system of Tanaka with an RFID sensor and corresponding scanning device, as taught by Chang. Doing so would merely involve combining prior art elements according to known methods to yield predictable results (that being tracking of the container), and thus a prima facie case of obviousness exists. The examiner notes that a scanning of an RFID on the container to determine information collected and related to the container is interpreted to a tag image recognition sensor correspondingly reading a tag identification code, and as such the prior art device reads to the claimed invention.
Regarding Claim 7, Tanaka, Fujisaki, Durkin, and Justice teach the chest drainage bottle system as claimed in claim 1. While Tanaka discloses data collection and transfer/storage to external devices such as a computer (para. 0082), Tanaka fails to teach the system further comprising: a cloud transmission device disposed in the chest drainage element disposing space and coupled to the liquid detection device, wherein the cloud transmission device is configured to transmit the liquid detection information from the liquid detection device to a cloud data analyzing device for cloud data analysis.
Chang teaches a fluid (breast milk) collection system and is thus considered analogous to the claimed invention. Chang teaches that containers record various data including extraction date/time, volume, and more and export said data to an external computer (smartphone) or an internet/cloud data base (para. 0273), such that data can be stored, readily identifiable and linked to specific containers. See also Chang para. 0281. Therefore, as Chang teaches that data storage based on fluid collection systems can be provided both along the internet to personal devices (smartphones etc.) and on cloud based systems, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the data (and transfer of said data to a device) of Tanaka to a cloud system and an internet system.
Regarding Claim 8, Tanaka, Fujisaki, Durkin, and Justice teach the chest drainage bottle system as claimed in claim 6. While Tanaka discloses data collection and transfer/storage to external devices such as a computer (para. 0082), Tanaka fails to teach the system further comprising: a cloud transmission device disposed in the chest drainage element disposing space and coupled to the liquid detection device, wherein the cloud transmission device is configured to transmit the liquid detection information from the liquid detection device to a cloud data analyzing device for cloud data analysis.
Chang teaches a fluid (breast milk) collection system and is thus considered analogous to the claimed invention. Chang teaches that containers record various data including extraction date/time, volume, and more and export said data to an external computer (smartphone) or an internet/cloud data base (para. 0273), such that data can be stored, readily identifiable and linked to specific containers. See also Chang para. 0281.Therefore, as Chang teaches that data storage based on fluid collection systems can be provided both along the internet to personal devices (smartphones etc.) and on cloud based systems, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the data (and transfer of said data to a device) of Tanaka to a cloud system and an internet system.
Regarding Claim 9, Tanaka, Fujisaki, Durkin, and Justice teach the chest drainage bottle system as claimed in claim 1. While Tanaka discloses data collection and transfer/storage to external devices such as a computer (para. 0082), there is no disclosure of the communication being remote.
Chang teaches a fluid (breast milk) collection system and is thus considered analogous to the claimed invention. Chang teaches that containers record various data including extraction date/time, volume, and more and export said data to an external computer (smartphone) or an internet/cloud data base (para. 0273), such that data can be stored, readily identifiable and linked to specific containers. Chang teaches that such communication can be done wirelessly or wired (para. 0275). See also Chang para. 0281. The examiner notes that communication between the device and external device of Chang is done by an RFID, NFC, or Bluetooth device (para. 0030) Therefore, as Chang teaches that data storage based on fluid collection systems can be provided both along the internet to personal devices (smartphones etc.) through a wired or wireless system, where wireless communication includes an RFID or Bluetooth device, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide and RFID of other wireless device for transfer of fluid data wirelessly to an external personal device of Tanaka (such as a laptop as disclosed in Tanaka) or to a cellphone, as taught by Chang.
Regarding Claim 10, Tanaka, Fujisaki, Durkin, and Justice teach the chest drainage bottle system as claimed in claim 6. While Tanaka discloses data collection and transfer/storage to external devices such as a computer (para. 0082), there is no disclosure of the communication being remote.
Chang teaches a fluid (breast milk) collection system and is thus considered analogous to the claimed invention. Chang teaches that containers record various data including extraction date/time, volume, and more and export said data to an external computer (smartphone) or an internet/cloud data base (para. 0273), such that data can be stored, readily identifiable and linked to specific containers. Chang teaches that such communication can be done wirelessly or wired (para. 0275). See also Chang para. 0281. The examiner notes that communication between the device and external device of Chang is done by an RFID, NFC, or Bluetooth device (para. 0030) Therefore, as Chang teaches that data storage based on fluid collection systems can be provided both along the internet to personal devices (smartphones etc.) through a wired or wireless system, where wireless communication includes an RFID or Bluetooth device, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide and RFID of other wireless device for transfer of fluid data wirelessly to an external personal device of Tanaka (such as a laptop as disclosed in Tanaka) or to a cellphone, as taught by Chang
Regarding Claim 11, Tanaka, Fujisaki, Durkin and Chang teach
The chest drainage bottle system as claimed in claim 9, wherein the remote mobile device is a wearable mobile device. The examiner notes that as detailed under the rejection of claim 9, laptops and smartphones were interpreted to be obvious and suitable personal devices for receiving data from the system. A smartphone is interpreted as a wearable device.
Regarding Claim 12, Tanaka, Fujisaki, Durkin and Chang teach
The chest drainage bottle system as claimed in claim 10, wherein the remote mobile device is a wearable mobile device. The examiner notes that as detailed under the rejection of claim 9, laptops and smartphones were interpreted to be obvious and suitable personal devices for receiving data from the system. A smartphone is interpreted as a wearable device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
Prosecution Insights