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 .
Claim Rejections - 35 USC § 112
Regarding claims 1, 9 and 17, the phrase "sufficient illumination" renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because the sufficiency of the illumination is not only determined by the structure of the light source (lumens, wavelength, etc.) but dependent on location of the light source relative to the endoscope and/or working area. Further, applicant’s specification does not define the meaning of “sufficient illumination”.
Regarding claims 1, 9 and 17, the phrase “without requiring any illumination device portion occupying a longitudinal channel through the endoscope during endoscopic viewing of the working area during the procedure” is unclear as the examiner is unsure whether the applicant is intending to claim that (1) the one or more light sources do not occupy any portion of the endoscope after the one or more light sources have been detached from the deployment device, or (2) there is no additional light sources or illumination in the endoscope. This limitation was not defined in the specification.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Velis (US2021/0267438) in view of Gat et al. (US2013/0053928).
Regarding claim 1, Velis discloses the endoscope system comprising:
an endoscope having an external proximal end and a subject-insertable distal end and an elongate body extending therebetween (various medical scopes including but not limited to ENT otoscope, naso-pharyngoscope, laparoscope, sinuscope, coloposcope, resectoscope and cystoscope [0094]), the elongate body including a working channel portion defining a dual-use channel within the endoscope, the channel having a size and shape configured to receive, at a first time, one or more medical devices (scopes may have channels, discharge ports for deployment of an intra-body medical device 5 from one or more portions of the probe portion of the scope while positioned in a lumen [0094]) and separately, at a second time, a medical instrument to perform the procedure (deployment devices, configured to be integrated with the endoscope, are medical instruments that are used during the procedure [0094-0095]);
the one or more medical devices configured to emit light, that illuminates a working area within a subject during an endoscopic procedure to provide sufficient illumination of the working area to allow viewing of the working area by an end-user via a viewing portion of the endoscope system without requiring any illumination device portion occupying a longitudinal channel through the endoscope during endoscopic viewing of the working area during the procedure (intra-body controllable medical device 5 captures images obtained by white light [0029-0031], strongly suggesting that there exists a light source and imaging system within medical device 5 that illuminates the working area so that images can be captured);
the medical instrument (deployment devices configured to be integrated with the endoscope [0094-0095]); and
wherein the one or more medical devices are configured to be: delivered to the working area via the channel using a deployment device; and detached from the deployment device and left at the working area for the second time (claw 152 or spring 153 may be used to hold and deploy medical device 5 [0095]; deployment device is not explicitly claimed and is only nominally recited to be configured to deliver the medical device 5, analogous to applicant’s one or more light sources via the channel, thus the deployment devices is interpreted as the applicant’s medical instrument and the deployment device); and subsequently retrieved from the working area through the working channel after the second time (medical devices 5 are capable of being deployed through the channel and discharge port of the endoscope, thus the endoscope and channel are sized and shaped to receive the medical devices 5 from the working area).
Although Velis teaches the one or more medical devices capable of capturing imaging obtained by white light, Velis fails to explicitly disclose a light source within the one or more medical devices. In the same field of endeavor, Gat teaches a substantially similar intra-body medical device comprising a light source configured to emit visible light, illuminating the working area with the visible light during a procedure to provide sufficient illumination of the working area to allow endoscopic viewing of the working area by an end-user via a viewing portion of the endoscope without requiring any illumination device portion occupying a longitudinal channel through the endoscope during the endoscopic viewing of the working area by the end-user during the procedure (illumination or radiation source of intra-body device may provide electromagnetic radiation within the visible spectrum, outside the visible spectrum, or a combination of both [0034]). In view of Gat, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the light source of Gat to the intra-body medical device of Velis, as it is known in the endoscope art that visible light sources emit white light that is required for imaging.
Regarding claim 5, Velis, modified by Gat, discloses the endoscope system of claim 1. Velis further teaches wherein the one or more medical devices are configured to free float at the working area or affix to a tissue at the working area (Fig. 9A-C: medical device 5 may comprise anchor 80 and tether 85 that attached to tissue as position P2 [0089]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Velis in view of Gat and Yamamoto et al. (US2007/0015961).
Regarding claim 6, Velis, modified by Gat, discloses the endoscope system of claim 5, however both fail to disclose wherein the one or more medical devices, comprising a light source, are configured to be retrieved via a basket configured to grab the one or more medical devices. In the same field of endeavor, Yamamoto teaches an endoscope system comprising an endoscope and a medical capsule (220), the endoscope further comprising a distal end (insertion section 12 of endoscope 10) wherein a basket retrieves the medical capsule (hood 200 collects medical capsule 220 [0090-0091]). In view of Yamamoto, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a retrieval device such as the basket of Yamamoto, to the endoscope of Velis, as it is known in art that the basket of Yamamoto is an equivalent alternative retrieval method removing an intra-body medical device from a body lumen.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Velis in view of Gat and Matsui et al. (US2008/0027283).
Regarding claim 7, Velis, modified by Gat, discloses the endoscope system of claim 5. Velis discloses wherein the one or more medical devices, comprising a light source, also include a magnet or electromagnet for moving the medical device relative to another magnet (magnets 88 are located within device 5 for push or pull propulsion with another magnet or magnetic field [0069]; magnets may be permanent or electromagnetic [0091]), but fails to disclose wherein a distal end of the endoscope includes an endoscope magnet or an endoscope electromagnet.
In the same field of endeavor, Matsui teaches an endoscope system (10) comprising an endoscope (14) and a capsule endoscope (12), wherein the capsule endoscope comprises a light source (Fig. 2: LED light source 26 within capsule 12), and wherein the capsule includes a magnet (Fig. 10: permanent magnet 206 on capsule 12), and a distal end of the endoscope includes an endoscope magnet (Fig. 10: permanent magnet 204 at the distal end of endoscope [0079-0081]). In view of Matsui, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the magnetic feature of Matsui, to the endoscope and medical device of Velis and Gat, as the magnetic coupling configuration taught by Matsui is known in art as an alternative and equivalent method for moving and removing intra-body medical devices including the one taught by Velis.
Claims 9-12, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Velis in view of Gerbo and Gat.
Regarding claim 9, Velis discloses the method comprising: deploying, using an endoscope having an external proximal end and a patient-insertable distal end and an elongate body extending therebetween (various medical scopes including but not limited to ENT otoscope, naso-pharyngoscope, laparoscope, sinuscope, coloposcope, resectoscope and cystoscope [0094]), via a working channel portion defining a dual-use channel within the elongate body of the endoscope, one or more medical devices to a working area within a patient at a first time using a deployment device (scopes may have channels, discharge ports for deployment of an intra-body medical device 5 from one or more portions of the probe portion of the scope while positioned in a lumen [0094]), the one or more medical devices configured to emit visible light (intra-body controllable medical device 5 captures images obtained by white light [0029-0031], strongly suggesting that there exists a light source and imaging system within medical device 5 that illuminates the working area so that images can be captured), the channel having a size and shape configured to receive the one or more medical devices (scopes may have channels, discharge ports for deployment of an intra-body medical device 5 from one or more portions of the probe portion of the scope while positioned in a lumen [0094]); leaving the one or more medical devices at the working area illuminating the working area with the visible light during a procedure to provide sufficient illumination of the working area to allow endoscopic viewing of the working area by an end-user via a viewing portion of the endoscope without requiring any illumination device portion occupying a longitudinal channel through the endoscope during the endoscopic viewing of the working area by the end-user during the procedure (intra-body controllable medical device 5 captures images obtained by white light [0029-0031], strongly suggesting that there exists a light source and imaging system within medical device 5 that illuminates the working area so that images can be captured). Velis fails to explicitly disclose the method comprising: deploying, via the working channel portion of the endoscope, a medical instrument to perform the procedure at a second time, separate from the first time.
In the same field of endeavor, Gerbo teaches an endoscope, comprising a working channel, the working channel, wherein the working channel may receive various tools, including a basket, and
wherein the tools may be removed from and inserted into the patient multiple times (endoscope 10,
comprising endoscope insertion tube 100, working channel 152, instruments such as laser may be used, or basket may be used [0343]). In view of Gerbo, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein the channel of Velis is used for multiple instruments, as taught by Gerbo, as it is well-known in the endoscope art that instrument channels typically allow the passage of multiple instruments dependent on the instrument needed at the step in the procedure.
Although Velis teaches the one or more medical devices capable of capturing imaging obtained by white light, Velis fails to explicitly disclose a light source within the one or more medical devices. In the same field of endeavor, Gat teaches a substantially similar intra-body medical device comprising a light source configured to emit visible light, illuminating the working area with the visible light during a procedure to provide sufficient illumination of the working area to allow endoscopic viewing of the working area by an end-user via a viewing portion of the endoscope without requiring any illumination device portion occupying a longitudinal channel through the endoscope during the endoscopic viewing of the working area by the end-user during the procedure (illumination or radiation source of intra-body device may provide electromagnetic radiation within the visible spectrum, outside the visible spectrum, or a combination of both [0034]). In view of Gat, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the light source of Gat to the intra-body medical device of Velis, as it is known in the endoscope art that visible light sources emit white light that is required for imaging.
Regarding claim 10, Velis, modified by Gerbo and Gat, discloses the method of claim 9. Velis further teaches the method comprising removing the one or more medical devices after the procedure has been performed at the working area (medical device 5 may be removed from body through peristalsis or may be withdrawn from the body by a tether [0084]).
Regarding claim 11, Velis, modified by Gerbo and Gat, discloses the method of claim 9. Velis further discloses wherein leaving the one or more medical devices at the working area during the procedure includes permitting the one or more medical devices to free float at the working area during the procedure (Fig. 1B, 17, 18, 21A, 21B, 22C: medical devices 5 appears to be free floating in working area; propulsion systems 30A, 30B suggest that medical device 5 is free floating [0079]).
Regarding claim 12, Velis, modified by Gerbo and Gat, discloses the method of claim 9. Velis further discloses the method comprising deploying the one or more medical devices through a working channel of the endoscope using a deployment device that disengages from the one or more medical devices (Fig. 13A-13C: medical device 5 can be deployed through the working channel 150 of endoscope 100, end of channel 150 may having docking station 151 which utilizes claw 152 or spring 153 to hold and deploy medical device 5 [0095]).
Regarding claim 14, Velis, modified by Gerbo and Gat, discloses the method of claim 12. Velis further disclose the method comprising, before disengaging the deployment device from the one or more medical devices, attaching the one or more medical devices to a distal end of the endoscope (Fig. 13A-C: before medical device 5 is disengaged from the spring 153 or claw 152, medical device 5 is attached to the distal end of the endoscope adjacent to the docking station 151).
Regarding claim 17, Velis discloses the method comprising: deploying, through an endoscope having an external proximal end and a patient-insertable distal end and an elongate body extending therebetween and having a working channel portion defining a dual-use channel of the endoscope (various medical scopes including but not limited to ENT otoscope, naso-pharyngoscope, laparoscope, sinuscope, coloposcope, resectoscope and cystoscope [0094]), one or more medical devices to a working area within a patient at a first time using a deployment device, the one or more medical devices configured to emit visible light, the channel having a size and shape configured to receive the one or more medical devices (scopes may have channels, discharge ports for deployment of an intra-body medical device 5 from one or more portions of the probe portion of the scope while positioned in a lumen [0094]); disengaging the deployment device to leave the one or more medical devices illuminating the visible light at the working area (Fig. 13A-13C: medical device 5 can be deployed through the working channel 150 of endoscope 100, end of channel 150 may having docking station 151 which utilizes claw 152 or spring 153 to hold and deploy medical device 5 [0095]); and retrieving, after the second time, the one or medical devices after the procedure has been performed at the working area (medical device 5 may be removed from body through peristalsis or may be withdrawn from the body by a tether [0084]).
Velis fails to explicitly disclose the method comprising: removing the deployment device from the working channel; deploying, via the working channel portion of the endoscope, a medical instrument to perform a procedure at a second time, separate from the first time while illuminating the visible light at the working area to provide sufficient illumination of the working area to permit an end-user to view the working area via a viewing portion of the endoscope without requiring any illumination device portion occupying a longitudinal channel through the endoscope during endoscopic viewing of the working area by the end-user during the procedure.
In the same field of endeavor, Gerbo teaches an endoscope, comprising a working channel, wherein the working channel may receive various tools, including a basket, and
wherein the tools are removed from and inserted into the patient multiple times (endoscope 10,
comprising endoscope insertion tube 100, working channel 152, instruments such as laser may be used, or basket may be used [0343]). In view of Gerbo, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein the lumen of Velis is used for multiple instruments, as taught by Gerbo, as it is well-known in the endoscope art that instrument channels typically allow the passage of multiple instruments dependent on the
instrument needed at the step in the procedure.
Although Velis teaches the one or more medical devices capable of capturing imaging obtained by white light, Velis fails to explicitly disclose a light source within the one or more medical devices. In the same field of endeavor, Gat teaches a substantially similar intra-body medical device comprising a light source configured to emit visible light, illuminating the working area with the visible light during a procedure to provide sufficient illumination of the working area to allow endoscopic viewing of the working area by an end-user via a viewing portion of the endoscope without requiring any illumination device portion occupying a longitudinal channel through the endoscope during the endoscopic viewing of the working area by the end-user during the procedure (illumination or radiation source of intra-body device may provide electromagnetic radiation within the visible spectrum, outside the visible spectrum, or a combination of both [0034]). In view of Gat, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the light source of Gat to the intra-body medical device of Velis, as it is known in the endoscope art that visible light sources are required for imaging.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Velis in view of Gerbo, Gat and Kimura et al. (US2019/0344093).
Regarding claim 13, Velis, modified by Gerbo and Gat, discloses the method of claim 12. While Velis teaches the medical device capable to attaching to tissue in the working area, Velis fails to explicitly disclose wherein the medical device is attached to the tissue before disengaging from the deployment device. In the same field of endeavor, Kimura teaches a method comprising deploying, using an endoscope having an external proximal end and a patient-insertable distal end and an elongate body extending therebetween (unillustrated endoscope [0064] is described to be inserted from the mouth, distal end of the endoscope placed inside body [0064], illustrated ultrasonic endoscope 90 of Fig. 13-14 show similarly), via a working channel portion defining a dual-use channel within the elongate body of the endoscope, one or more medical devices to a working area within a patient at a first time using a deployment device, the channel having a size and shape configured to receive the one or more medical devices (carrier device 60 housing the treatment tool 10 is shifted through lumen of an unillustrated endoscope [0064], capsule 35 houses light emitting member 30 [0039] attached to treatment tool 10 which is delivered by carrier device 60, as seen in Fig. 4); leaving the one or more medical devices at the working area during a procedure (carrier device can be pulled out of the body while the treatment tool 10 and 10A are left in the body as seen in Fig. 6 [0065]). Kimura further teaches wherein the light source is attached to tissue at the working area before disengaging from the deployment device. In view of Kimura, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the method of attaching the medical device of Velis to tissue in the working area before disengaging from the deployment device, as it allows the intra-body medical device to be precisely positioned near the tissue that must be illuminated.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Velis in view of Gerbo, Gat and Yamamoto.
Regarding claim 15, Velis, modified by Gerbo and Gat, discloses the method of claim 10, but fails to disclose wherein removing the one or more medical devices includes using a basket device to attach to the one or more medical devices. In the same field of endeavor, Yamamoto teaches an endoscope system comprising an endoscope and a medical capsule (220), the endoscope further comprising a distal end (insertion section 12 of endoscope 10) wherein a basket retrieves the medical capsule (hood 200 collects medical capsule 220 [0090-0091]), wherein the medical capsule is removed after a procedure has been performed (medical capsule 220 is held at the distal end of endoscope 10, endoscope 10 is withdrawn out of the body cavity to bring the medical capsule 220 to the outside of the body cavity and collect it [0091]). In view of Yamamoto, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the basket method for removal of an intra-body medical device, as taught by Yamamoto, to the method of Velis, as it is a known alternative method for removing an intra-body medical device from the body.
Regarding claim 16, Velis, modified by Gerbo and Gat, discloses the method of claim 10, but fails to explicitly disclose wherein removing the one or more medical devices includes attaching the one or more medical devices to the endoscope and further comprising removing the one or more medical devices by removing the endoscope. Yamamoto teaches an endoscope system comprising an endoscope and a medical capsule (220), the endoscope further comprising a distal end (insertion section 12 of endoscope 10) wherein a basket retrieves the medical capsule (hood 200 collects medical capsule 220 [0090-0091]), wherein the medical capsule is removed after a procedure has been performed (medical capsule 220 is held at the distal end of endoscope 10, endoscope 10 is withdrawn out of the body cavity to bring the medical capsule 220 to the outside of the body cavity and collect it [0091]). In view of Yamamoto, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the removal method for an intra-body medical device, as taught by Yamamoto, to the method of Velis, as it is a known alternative method for removing an intra-body medical device form the body.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Velis in view of Gat and Gerbo.
Regarding claim 18, Velis, modified by Gat, discloses the endoscope of claim 1. While Velis discloses the size of the medical device to be dependent on the procedure, and most preferably, that the diameter of the medical device is less than 15mm and the length less than 50mm ([0079]; medical device 5 can be nano-sized to fit into smaller areas [0095]), Velis fails to specifically disclose the diameter size of the endoscope. In the same field of endeavor, Gerbo teaches an endoscope comprising a working channel, wherein the working channel may receive various medical instruments, further teaching wherein the size of the endoscope diameter is 2.67-3.33 millimeters (outer diameter of the insertion tube 100 may be 2-3 mm [0323], 2.67- 3.00 mm falls between range of applicant). Since Velis fails to disclose the sizing details of the endoscope diameter, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any known endoscope diameter size in the endoscope art, including the one taught by Gerbo, as the endoscope diameter size of the endoscope of Velis.
Regarding claim 19, Velis, modified by Gat, discloses the endoscope system of claim 1. Velis fails to disclose wherein the medical instrument includes a stone basket for kidney stone retrieval. In the same field of endeavor, Gerbo teaches an endoscope comprising a working channel, the working channel configured to receive a medical instrument, including a stone basket to perform a portion of the procedure at the working area, wherein the working area includes a target location at a kidney of a patient anatomy, wherein the stone basket is configured to retrieve kidney stone or calculi fragments ([0343]). In view of Gerbo, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that a variety of instruments, including the stone basket taught by Gerbo, may be passed through the working channel of Velis, dependent on the procedure [0343].
Regarding claim 20, Velis, modified by Gat, discloses the endoscope of claim 1, but fails to disclose the endoscope diameter and wherein the medical instrument includes a stone basket. In the same field of endeavor, Gerbo teaches an endoscope with a diameter between 2.67-3.33 mm (outer diameter of the insertion tube 100 may be 2-3 mm [0323], 2.67-3.00 mm falls between range of applicant), comprising a working channel, the working channel configured to receive a medical instrument, the medical instrument to perform the procedure at the second time, wherein the medical instrument includes a stone basket to perform a portion of the procedure at the working area, wherein the working area includes a target location at a kidney of a patient anatomy, wherein the stone basket is configured to retrieve kidney stone or calculi fragments ([0343]).
Since Velis fails to disclose the sizing details of the endoscope diameter and the stone basket
instrument, it would have been obvious to one of ordinary skill in the art before the effective filing date
of the claimed invention to have used any known endoscope diameter size in the endoscope art,
including the one taught by Gerbo, as the endoscope diameter size of the endoscope of Velis. In view
of Gerbo, it would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to have recognized that a variety of instruments, including the stone basket
taught by Gerbo, may be passed through the working channel of Velis, dependent on the procedure
[0343].
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Velis in view of Gerbo, Gat and Weirich (US2007/0238921).
Regarding claim 21, Velis, modified by Gerbo and Gat, discloses the method of claim 9. While Velis discloses wherein images may be obtained by fluorescence imaging ([0031,0039]) but fails to explicitly disclose wherein one or more light sources comprise a fluorescent fluid injected toward the working area via the working channel. In the same field of endeavor, Weirich teaches an in-vivo imaging device comprising a light source, the light source including a laser diode or LED and fluorescent dye that emits visible light (shell 2; use of laser diode or UV LED individually or in combination with other light sources illuminate targeted tissue [0037], fluorescent dyes fluoresce visible light by shining UV, blue or laser light on them [0008]). In view of Weirich, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the fluorescent fluid of Weirich to the device of Velis, as, it is well known in the endoscope art the fluorescence imaging comprising fluorescent fluid injected into tissue to illuminate targeted tissue for better visibility [0011].
Response to Arguments
Applicant’s arguments with respect to claims 1, 9 and 17 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. Instead, new grounds or rejection based on Velis is presented in the above to evidence the Office’s Position.
Velis teaches an intra-body medical device, comprising an imaging system capable of obtaining images by white light and fluorescence, highly suggesting the intra-body medical device comprises white-light sources to provide sufficient illumination to the working area to allow viewing of the working area, without requiring any illumination device potion to occupy a longitudinal channel through the endoscope in which the intra-body medical device was delivered and deployed through.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited in PTO-892.
THIS ACTION IS MADE FINAL. 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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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/03/26