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 .
Status of Claims
Claims 1-19 are currently pending. Claims 1, 2, and 17 have been currently amended. No new claims have been added.
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.
Claims 1-4, 6, 9, 11, 14-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Muto (US 4468216 A) in view of Bengtson (US 20140088529 A1) and in further view of Xu (CN 105126183 A, as mapped in translated copy attached).
Regarding Claim 1, Muto teaches a fluid management device (irrigation suction catheter 20) for controlling fluid at a surgical site (41), comprising:
a flexible tube (21) having a distal end (22), a proximal end (25), and a length therebetween (see Figure 1; Col. 2 ln 46-60), wherein the length extends along a longitudinal axis and wherein the distal end comprises a distal opening (38, see Col. 3 ln 6) configured to communicate fluid between the flexible tube and the surgical site (see Figures 1-2);
a dual flow adapter (Y coupling 26; Col. 2 ln 52-60; Figure 1-4) having a main port (where Y coupling 26 connects to proximal end 25, see Figure 1), a first branch (27) configured to couple to a vacuum source (source of suction 29), and a second branch (43) configured to interchangeably couple to one of a fluid source (a source of pressurized irrigation fluid 46; If no irrigation tube is needed, the tube 33 is slidably removed by the finger grip 44 and the cap 51 fitted over the rim 49 of branch 43 to also seal the branch and convert the device to a suction catheter only, see Col. 3 ln 55-59; Figure 3).
However, Muto does not explicitly disclose the second branch configured to interchangeably couple to a fluid source and an aspiration adapter, the fluid aspiration adaptor configured to provide fluid aspiration through the flexible tube; and a porous absorption element fixably coupled to a portion of the length of the flexible tube such that the porous absorption element encloses the distal end.
Bengtson teaches a fluid management device (a novel endoscopic surgical device, see Paragraph [0006]) comprising: a fluid adaptor (assembly 10, see Figure 1 and 19-20) with a branch (tubing 30 establishes a fluid conduit between the device and an external device, see Paragraph [0070]) configured to interchangeably couple to a fluid adaptor (configured to couple to a fluid delivery device3 4, see Figure 20) and an aspiration adapter (configured to be coupled to vacuum device 32, see Figure 19), the fluid aspiration adaptor configured to provide fluid aspiration through a flexible tube (the tubing 30, which may be connected to an external suction device 32, can actively remove fluids from the body cavity, see Paragraph [0070]); and a porous absorption element (absorbent device 20) fixably coupled to a portion of the length of the flexible tube such that the porous absorption element encloses the distal end (absorbent device 20 is at the distal end of tubing 30. see Figure 19).
Muto and Bengtson are analogous art because both teach a suction/irrigation catheter for suctioning/delivering fluids from the body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the second branch of Muto and further include wherein the second branch is configured to interchangeably couple an aspiration adapter, as taught by Bengtson. Bengtson teaches having an interchangeable suction source can actively remove fluids from the body cavity, thereby allowing the absorbent device 20 to remain in place without the need to rinse or wring out the device during a laparoscopic procedure. Such an arrangement minimizes the need to remove the absorbent device during a procedure, or possible allows for the absorbent device to stay in place during an entire procedure, and removed upon completion of the substantive procedure, prior to removal of the cannula, see Paragraph [0070]. Also, it would be beneficial to have a dual suction system in Muto in case the first suction source in the first branch fails.
Muto and Bengtson teaches all of the limitations as discussed above. However, Muto and Bengtson do not explicitly teaches an intermittent aspiration adapter.
Xu teaches a suction catheter (see Figure 1; Abstract) comprising and an intermittent aspiration adapter (negative pressure interface 3), the intermittent fluid aspiration adaptor configured to provide intermittent fluid aspiration through the flexible tube (finger can be used to prevent gas leakage through the hole 5 and tube 1, see Figure 1).
Muto, Bengtson, and Xu are analogous art because both disclose a suction catheter for suctioning fluids from the body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the aspiration adaptor in the second branch of Modified Muto and further include an intermittent aspiration adaptor interchangeable coupled to the second branch, as taught by Xu. Xu teaches the device greatly simplifies the working procedure, shortens the time of oral cavity clean and reduce the pain of the patient and reduces the labor intensity of the medical staff, and has strong cleaning ability, it is safe to use (see Abstract).
Regarding Claim 2, Modified Muto teaches all of the limitations of claim 1 and Muto further teaches wherein the first branch (27) is coupled to the vacuum source (29) via an aspiration tube (28).
Regarding Claim 3, Modified Muto teaches all of the limitations of claim 1 and Muto further teaches wherein: the main port (26) is coupled to the proximal end of the flexible tube (25, see Figure 1); and the first branch is disposed at an acute angle relative to the main port (see Figure 1 and 4)
Regarding Claim 4, Modified Muto teaches all of the limitations of claim 2 and Muto further teaches the vacuum source, wherein the vacuum source is in fluid communication with the flexible tube (proximal end 25 of suction tube 21 is connected to a Y coupling 26, one branch 27 thereof being connected by conduit 28 to a source of suction 29 such as hospital suction or a vacuum pump, see Col.2 ln 52-55) and configured to provide continuous aspiration from the surgical site (suction source 29 is a vacuum pump or hospital suction).
Regarding Claim 6, Modified Muto teaches all of the limitations of claim 1 and Xu further teaches wherein the intermittent aspiration adapter (negative pressure interface 3) is configured to provide intermittent fluid aspiration through the flexible tube (putting the finger on the hole 5, through loosing and compacting the intermittent operation, see pg. 4 ln 5-6).
Regarding Claim 9, Modified Muto teaches all of the limitations of claim 1 and Muto further teaches wherein the second branch (43) of the dual flow adapter is coaxial with the main port (see Figure 1).
However, Muto and Xu do not explicitly disclose wherein the second branch includes a greater cross-sectional diameter than the first branch.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Muto to have a second branch with a greater cross-sectional diameter than the first branch since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Muto would not operate differently with the claimed cross-sectional diameter and since the second branch is intended to have a diameter large enough to provide instillation therapy or negative pressure the device would function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (specification pp. [0069]).
Regarding Claim 11, Modified Muto teaches all of the limitations of claim 1 and Muto further teaches the fluid source (46) coupled to the second branch to deliver fluid to the surgical site through the flexible tube (see Col. 3 ln 22-27).
Regarding Claim 14, Modified Muto teaches all of the limitations of claim 1 and Xu further teaches wherein the porous absorption element comprises a shape selected from the group consisting of a rectangular prism, a dome, a cone, a triangular spear, a cube, a pyramid, an elliptical sphere, and a circular sphere (sponge 2 has a cube shape, see Figure 1).
Regarding Claim 15, Modified Muto teaches all of the limitations of claim 1 and Xu further teaches wherein the porous absorption element is fixably coupled to the portion of the length of the flexible tube via at least one of a press fit, an adhesive, stitching, and a mechanical bond (the front end of the hollow tube 1 fits into the sponge 2, and adopts non-toxic medical grade glue fixedly connected with the sponge 2, see pg. 3 ln 9-10).
Regarding Claim 17, Modified Muto teaches all of the limitations of claim 2 and Muto further teaches wherein an aspiration tube (28) is directly coupled to the vacuum source (29) such that the vacuum source provides continuous suction through the aspiration tube (Figure 1).
Regarding Claim 18, Modified Muto teaches all of the limitations of claim 1 and Muto further teaches wherein the fluid source comprises one of a fluid-filled bag and a syringe (irrigation source 46 may be a saline solution 47 in a pressurized tank or a pump and tank apparatus not shown, see Col. 3 ln 16-17).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Muto, Bengtson, and Xu as applied to claim 4 above, and further in view of Ahmed et al. (US 20210393907 A1), hereinafter referred to as “Ahmed”.
Regarding Claim 5, Modified Muto teaches all of the limitations of claim 4. However, Muto and Xu does not explicitly disclose a continuous aspiration adapter disposed between the vacuum source and the aspiration tube, wherein the continuous aspiration adapter includes an elongate body having a first end, a second end, and a center between the first end and the second end, the continuous aspiration adapter increasing in diameter from the first end and the second end toward the center such that the diameter of the continuous aspiration adapter tapers from its center toward the first end and the second end, the second end of the continuous aspiration adapter coupled to the vacuum source.
Ahmed teaches a vacuum assisted drain connector (see Abstract; Figures 1-4) comprising: a continuous aspiration adapter (connector 110) disposed between the vacuum source (112) and the aspiration tube (102), wherein the continuous aspiration adapter includes an elongate body (see Figure 1) having a first end (see below), a second end (see below), and a center between the first end and the second end (see below), the continuous aspiration adapter increasing in diameter from the first end and the second end toward the center such that the diameter of the continuous aspiration adapter tapers from its center toward the first end and the second end (see below), the second end of the continuous aspiration adapter
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coupled to the vacuum source (second end coupled to vacuum source (112), see Figure 1).
Muto, Bengtson, Xu, and Ahmed are analogous art because all teach a suction catheter with an adaptor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the adaptor of modified Muto and further include a continuous aspiration adaptor disposed between the vacuum source and the aspiration tube, as taught by Ahmed. Ahmed teaches the connector can couple the suction catheter to tubing associating with the suction machine. In some embodiments, the connector can include a one-way valve to regulate a direction of secretion passage through the connector (see Paragraph [0008] and [0055]).
Claims 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Muto, Bengtson, and Xu as applied to claim 1 above, and further in view of Abrahams et al. (US 20200138417 A1), hereinafter referred to as “Abrahams”.
Regarding Claim 7, Modified Muto teaches all of the limitations of claim 1 and Xu further teaches an intermittent aspiration adaptor (3). However, Modified Muto does not explicitly disclose wherein the intermittent aspiration adapter comprises an elongate body having an interior surface for fluid communication, a first end, a second end, a middle section, and a center on the middle section, the intermittent aspiration adapter increasing in diameter from the first end and the second end toward the middle section such that the diameter of the intermittent aspiration adapter tapers from the middle section toward the first end and the second end, the middle section including a uniform cross-sectional diameter and a valve extending orthogonally outwardly therefrom, the valve in fluid communication with the interior surface and including a distal end having an opening for selectively occluding to provide a controlled intermittent vacuum force and intermittent aspiration to a surgical site.
Abrahams teaches an intermittent aspiration adapter (10) comprises an elongate body (3) having an interior surface for fluid communication (see Figure 1), a first end (nozzle 4), a second end (proximal end 31), a middle section (tubular body 3), and a center on the middle section (center of tubular body 3, see Figure 1), the intermittent aspiration adapter increasing in diameter from the first end and the second end toward the middle section such that the diameter of the intermittent aspiration adapter tapers from the middle section toward the first end and the second end (nozzle 4 tapers to body 3 and the progressively larger diameter stepped connectors 30′ on the second end tapers to the middle of body 3, and see Figure 3), the middle section including a uniform cross-sectional diameter (internal diameter D2 is uniform, see Figure 2) and a valve extending orthogonally outwardly therefrom (port opening 23), the valve in fluid communication with the interior surface (see Figure 2; Paragraph [0051]) and including a distal end having an opening for selectively occluding to provide a controlled intermittent vacuum force and intermittent aspiration to a surgical site (covering and uncovering the opening 23 may be used to control suction through the device 10, see Paragraph [0051]).
Muto, Bengtson, Xu, and Abrahams are analogous art because all teach and adaptor for a suction catheter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the intermittent aspiration catheter of modified Muto and replace it with the intermittent aspiration catheter having an increase in diameter from the first end and the second end toward the middle section such that the diameter of the intermittent aspiration adapter tapers from the middle section toward the first end and the second end, as taught by Abrahams. Abrahams teaches the internal diameter where the body 3 is connected to the nozzle 4 provides a smooth transition from the nozzle 4 to the body 3 so that there are no shelves or obstacles that initiate clogging of the device 10 (see Paragraph [0053]) and the progressively larger diameter stepped connectors 30′ thus allow connection to a variety of operation room suction line diameters (see Paragraph [0048]).
Regarding Claim 8, Modified Muto teaches all of the limitations of claim 1 and Xu further teaches an intermittent aspiration adaptor (3). However, Modified Muto does not explicitly disclose wherein the intermittent aspiration adapter comprises an interior surface for fluid communication, a first end, a second end, a middle section, and a center on the middle section, the intermittent aspiration adapter extending from the first end to the second end along the longitudinal axis and increasing in diameter from the first end and the second end toward the middle section such that the diameter of the intermittent aspiration adapter tapers from the middle section toward the first end and the second end, the middle section including a uniform cross-sectional diameter and a funnel valve extending orthogonally outwardly therefrom, the funnel valve in fluid communication with the interior surface and including an opening and a nipple closure, the nipple closure including a nipple configured to selectively occlude the opening to provide a controlled intermittent vacuum force and intermittent aspiration to a surgical site.
Abrahams teaches an intermittent aspiration adapter (10) comprises an interior surface for fluid communication (space 35″), a first end (nozzle 4), a second end (proximal end 31), a middle section (body 3), and a center on the middle section (center of body 3), the intermittent aspiration adapter extending from the first end to the second end along the longitudinal axis and increasing in diameter from the first end and the second end toward the middle section such that the diameter of the intermittent aspiration adapter tapers from the middle section toward the first end and the second end (nozzle 4 tapers to body 3 and the progressively larger diameter stepped connectors 30′ on the second end tapers to the middle of body 3, and see Figure 3), the middle section including a uniform cross-sectional diameter (see Figure 2) and a funnel valve (port opening 23) extending orthogonally outwardly therefrom (see Figures 2 and 3), the funnel valve in fluid communication with the interior surface (a port opening 23 in cylindrical wall 36 that enables fluidic communication with the ambient air to the first and second internal volumes of space 35′ and 35″, see Paragraph [0051]) and including an opening and a nipple closure (port opening 23 and luer cap 2), the nipple closure including a nipple configured to selectively occlude the opening to provide a controlled intermittent vacuum force and intermittent aspiration to a surgical site (a Luer cap 2 may be placed over the port opening 23 in cylindrical wall 36 of the body 3 to seal the device 10 from the ambient air, see Paragraph [0064]).
Muto, Bengtson, Xu, and Abrahams are analogous art because all teach and adaptor for a suction catheter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the intermittent aspiration catheter of modified Muto and replace it with the intermittent aspiration catheter having an increase in diameter from the first end and the second end toward the middle section such that the diameter of the intermittent aspiration adapter tapers from the middle section toward the first end and the second end, as taught by Abrahams. Abrahams teaches the internal diameter where the body 3 is connected to the nozzle 4 provides a smooth transition from the nozzle 4 to the body 3 so that there are no shelves or obstacles that initiate clogging of the device 10 (see Paragraph [0053]) and the progressively larger diameter stepped connectors 30′ thus allow connection to a variety of operation room suction line diameters (see Paragraph [0048]).
Regarding Claim 10, Modified Muto teaches all of the limitations of claim 1. However, Modified Muto does not explicitly disclose wherein the second branch includes an adapter extension portion tapering in diameter from the main branch towards an end of the adapter extension portion and defines varying thread sizes to accommodate connection with various ports or tubes.
Abrahams teaches an adapter (10) extension portion tapering in diameter from the main branch towards an end of the adapter extension portion (progressively larger diameter stepped connectors 30′) and defines varying thread sizes to accommodate connection with various ports or tubes (the stepped connectors 30′ allow direct connection to a variety of operating room suction line tube sizes that may be available to the user such that they provide for an integral “universal connector” in the device 10, see Paragraph [0048]).
Muto, Bengtson, Xu, and Abrahams are analogous art because all teach and adaptor for a suction catheter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the second branch of modified Muto and further include an adaptor extension portion tapering in diameter from the main branch towards an end of the adapter extension portion, as taught by Abrahams. Abrahams teaches it is beneficial that the internal diameter where the body 3 is connected to the nozzle 4 provides a smooth transition from the nozzle 4 to the body 3 so that there are no shelves or obstacles that initiate clogging of the device 10 (see Paragraph [0053]) and the progressively larger diameter stepped connectors 30′ thus allow connection to a variety of operation room suction line diameters (see Paragraph [0048]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Muto, Bengtson and Xu as applied to claim 1 above, and further in view of Siedle et al. (EP 2394677 A1), hereinafter referred to as “Siedle”.
Regarding Claim 12, Modified Muto teaches all of the limitations of claim 1. However, Modified Muto does not explicitly disclose wherein the distal end of the flexible tube includes a plurality of lateral openings configured to receive a flow of fluid therethrough.
Siedle teaches a medical product (10), particularly for removing body liquids from human and/or animal body cavities, comprising an absorbent body (12), a drainage tube (14); wherein the distal end of the flexible tube (14) includes a plurality of lateral openings configured to receive a flow of fluid therethrough (22).
Muto, Bengtson, Xu, and Siedle are analogous art because all teach a suction catheter for removing body fluids.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the flexible tube of modified Muto and further include a plurality of lateral openings, as taught by Siedle. Siedle teaches the openings allow for a better liquid transfer from the absorbent body 12 into the drainage tube 14 (see Paragraph [0022]).
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Muto, Bengtson, and Xu as applied to claim1 above, and further in view of Asum (US 20180193120 A1).
Regarding Claim 13, Modified Muto teaches all of the limitations of claim 1. However, Modified Muto does not explicitly disclose an end manifold coupled to the distal end of the flexible tube, the end manifold comprising a plurality of perforations configured to receive a flow of fluid therethrough.
Asum teaches a dental suction arrangement (see Abstract) comprising an end manifold (suction part 103) coupled to the distal end of the flexible tube (the suction part 103 may alternatively be joined to a juncture 105 between the suction part 103 and the exposed part 102 of the suction tube 101, see Paragraph [0148]; see Figure 24), the end manifold comprising a plurality of perforations (holes 104) configured to receive a flow of fluid therethrough (suction part 103 comprises holes through which saliva or similar fluids may be sucked away, see Paragraph [0147]).
Muto, Bengtson, Xu, and Asum are analogous art because all teach a suction catheter for removing body fluids.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the suction catheter of modified Muto and further include an end manifold with a plurality of perforations, as taught by Asum. Asum teaches the need of absorption may vary and from a flow technical point of view it is favorable to be able to have different sized holes depending on their distance to the connection of the absorptions part to the rest of the suction device (see Paragraph [0038]).
Regarding Claim 19, Modified Muto teaches all of the limitations as taught in claim 13 and Asum further teaches wherein an absorption element (absorption body 11) encloses the end manifold (suction part 103 embedded in the absorption body, see Paragraph [0119]; Figure 24).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Muto, Bengtson, and Xu as applied to claim 1 above, and further in view of Skow (WO 9724972 A1).
Regarding Claim 16, Modified Muto teaches all of the limitations of claim 1. However, Modified Muto does not explicitly disclose wherein the porous absorption element comprises an antithrombotic material.
Skow teaches a surgical device for removing fluids (see Abstract) comprising a suction catheter (26) and a porous absorption element (matt 22) connected at the distal end (see Figure 1); and wherein the porous absorption element comprises an antithrombotic material (mat 22 may be heparinized before use, see pg. 10 ln 4).
Muto, Bengtson, Xu, and Skow are analogous art because all teach a suction catheter for removing body fluids.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the porous absorption element of Modified Muto and further include wherein the porous absorption element comprises an antithrombotic material, as taught by Skow. Skow teaches by heparinizing the matt before use, blood clotting can be inhibited (see pg. 10 ln 4).
Response to Arguments
Applicant’s arguments, see pg. 1, filed 08/12/2025, with respect to Claims 1-19 have been fully considered and are persuasive. The Double Patenting Rejection of Claims 1-19 has been withdrawn.
Applicant’s arguments, see pg. 1, filed 08/12/2025, with respect to Claims 17 have been fully considered and are persuasive. The 112(b) Rejection of Claim 17 has been withdrawn.
Applicant’s arguments with respect to claim 1 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.
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.
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/ERIC RASSAVONG/ (12/19/2025)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781