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finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Feb 5, 2025 has been entered.
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 1-11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pouletty
et al. (US2024/0009839) in view of Duan et al. (US2022/0022736).
Regarding claim 1, Pouletty discloses a magnetically driven capsule comprising: a camera
assembly configured to take images, provide video, or both (camera [0036]); a light assembly configured
to illuminate areas surrounding the camera assembly (light signals are transmitted through transmission cable to the medical device [0024]); an magnet (body part of medical device may comprise a magnetic part to be used to guide the medical device by interaction with an external magnetic field [0035]); an outer covering surrounding the camera assembly, light assembly, and magnet (body part 11 and body part 12/tail end 12 would surround the camera assembly, light assembly and magnetic part); wherein a proximal end straight edge is configured to allow a connection element to extend from a midpoint of the proximal end straight edge of the capsule (Fig. 6: proximal end, also called tail end 12, comprises a straight edge that allows for connection with controlling line 13 [0155]); and wherein the connection element is configured as a wire to provide power to the camera assembly, provide power to the light assembly, provide a connection to a computer screen for imaging, or combinations thereof (controlling line 13 comprises an energy transmission cable 20 and a data transmission cable 31 which transmits energy and data to and from the medical device [0160]). Pouletty fails to further describe details of the camera assembly, light assembly, particularly their locations within the medical device relative to the connection element. Pouletty also discloses the magnet to be an external coating on the body part of the medical device, therefore failing to disclose the magnet to be internal.
However, in the same field of endeavor, Duan teaches a substantially similar magnetically drive
capsule device, comprising: a camera assembly configured to take images, provide video, or both
(imaging system 230 [0068]); a light assembly configured to illuminate areas surrounding the camera
assembly (illumination system 220 include three or more LEDs 222 [0068]); an internal magnet (one or
more magnets 240 [0065]; magnet 640 in Fig. 6C); an outer covering surrounding the camera assembly,
light assembly, and magnet (housing 210 for housing the imaging system 230, an illumination system
220 and magnets 240 [0065]); wherein the capsule includes a first end positioned adjacent to the
camera assembly and the light assembly (Fig. 6C: distal illumination system 620b and distal imaging
system 630b are adjacent to the first end, the distal end [0077]), an opposed second end defined by an
elongated region with a straight edge adjacent to the internal magnet, the elongated region and straight
edge configured to allow a connection element to extend from a midpoint of the second end of the
capsule (Fig. 6C: tether 720 is attached at the midpoint of proximal end of the capsule; Fig. 9: magnet
640 may be placed toward the proximal end of the capsule endoscope 600 [0082]); and wherein the connection element is configured as a wire to provide power to the camera assembly, provide power to
the light assembly, provide a connection to a computer screen for imaging, or combinations thereof
(control signals and image data may be communicated to and from the capsule endoscope through the tether [0061]). Since Pouletty fails to disclose the specifics of the camera assembly, illumination
assembly within the capsule, 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 camera assembly and illumination
assembly configuration in a magnetic capsule known in the endoscope art, including the one taught by
Duan. In view of Duan, 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 the internal magnet of Duan is an equivalent
alternative of the magnetic capsule head of Pouletty, as both are the magnetic component of the
capsule inside the body cavity that interacts with the external magnet outside the patient body to
maneuver the capsule through the body cavity.
Regarding claim 2, Pouletty, modified by Duan, discloses the magnetically driven capsule of
claim 1. Duan further discloses wherein the camera assembly comprises a digital camera or a digital
video camera (although neither Pouletty nor Duan explicitly stated their camera or imaging system to be digital, it is highly suggested that the imaging system of Duan include CMOS image sensors that are
digital [0060]).
Regarding claim 3, Pouletty, modified by Duan, discloses the magnetically driven capsule of
claim 1. Although Pouletty does not explicitly disclose wherein the camera assembly is configured to
provide a two-dimensional or three-dimensional image, it is obvious that the camera is to provide two-
dimensional or three-dimensional images ([0036]). Duan also teaches wherein the camera assembly is
configured to provide a two-dimensional or three-dimensional image (image sensors for obtaining
images of the environment around the endoscope capsule [0060]).
Regarding claim 4, Pouletty, modified by Duan, discloses the magnetically driven capsule of
claim 1. Duan further teaches wherein the light assembly comprises one or more light emitting diodes (illumination system include three or more LEDs 222 [0068]).
Regarding claim 5, Pouletty, modified by Duan, discloses the magnetically driven capsule of
claim 1. Pouletty discloses wherein the magnetic part of the medical device is a permanent magnet that
remains magnetized (magnetic head part comprises of neodymium (Nd-Fe-B) magnet [0113], which is
known to be a permanent magnet). Duan teaches wherein the internal magnet is a permanent magnet
that remains magnetized (internal magnets may be permanent magnets [0116]).
Regarding claim 6, Pouletty, modified by Duan, discloses the magnetically driven capsule of
claim 1. Pouletty discloses wherein the magnetic part of the medical device comprises steel,
neodymium, samarium cobalt, ceramic, aluminum nickel cobalt, iron, nickel, cobalt, alloy of rare earth
metals, lodestone, or combinations thereof (magnetic head part comprises of neodymium (Nd-Fe-B)
magnet [0113]). Duan also teaches wherein the internal magnet of the capsule comprises steel,
neodymium, samarium cobalt, ceramic, aluminum nickel cobalt, iron, nickel, cobalt, alloy of rare earth
metals, lodestone, or combinations thereof (internal magnets may be rare earth magnets such as
neodymium magnets [0116]).
Regarding claim 7, Pouletty, modified by Duan, discloses the magnetically driven capsule of
claim 1. Pouletty further discloses the capsule comprising a power source and communication source
configured as a wire attached to an external supply (Fig. 6: controlling line 13 comprises a data
transmission cable 31 and an energy transmission cable 30 [0160]).
Regarding claim 8, Pouletty, modified by Duan, discloses the magnetically driven capsule of
claim 1. Pouletty fails to disclose the capsule further comprising an accelerometer, a gyroscope, or both.
Duan teaches a magnetically drive capsule further comprising an accelerometer, a gyroscope, or both
(posture sensor such as a gyroscope may one of the various electronic components in the capsule
housing [0065]). In view of Duan, 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 gyroscope, such as the one taught in Duan, to the capsule of Pouletty, as inertia measurement devices are known in the capsule endoscope art to measure angular displacement of the capsule endoscope while in a body cavity.
Regarding claim 9, Pouletty, modified by Duan, discloses the magnetically driven capsule of
claim 1. Pouletty further discloses the capsule comprising a length of about 2 centimeters or less and a
diameter of about 1 centimeter or less (medical device has preferably a size of 200-500 μm, which is
equivalent to 0.02-0.05 cm, which can be the length, diameter or longest dimension of the medical
device [0046]). Duan also teaches wherein the capsule comprises a length of about 2 centimeters or less
and a diameter of about 1 centimeter or less (housing may have a length of 15-30mm and a diameter of between 6-12mm [0066]).
Regarding claim 10, Pouletty discloses a system for guiding a magnetically driven capsule, the
system comprising: a magnetically driven capsule defined by: a camera assembly configured to take
images, provide video, or both (camera [0036]); a light assembly configured to illuminate areas
surrounding the camera assembly (light signals are transmitted through transmission cable to the
medical device [0024]); a magnet (body part of medical device may comprise a magnetic part to be
used to guide the medical device by interaction with an external magnetic field [0035]); an outer
covering surrounding the camera assembly, light assembly, and magnet (body part 11 and body part
12/tail end 12 would surround the camera assembly, light assembly and magnetic part); wherein the
capsule includes a proximal end straight edge is configured to allow a connection element to extend
from a midpoint of the proximal end straight edge of the capsule (Fig. 6: proximal end, also called tail
end 12, comprises a straight edge that allows for connection with controlling line 13 [0155]); wherein
the connection element is configured as a wire to provide power to the camera assembly, provide
power to the light assembly, provide a connection to a computer screen for imaging, or combinations
thereof (controlling line 13 comprises an energy transmission cable 20 and a data transmission cable 31 which transmits energy and data to and from the medical device [0160]); an external magnet that
exhibits magnetic attraction to the magnet sufficient to guide a location of the magnetically driven
capsule; wherein the external magnet is sufficient to maneuver the capsule via magnetic attraction with
the magnet of the capsule (external magnetic field generator created a magnetic field to guide the
medical device to the application site [0035 & 0083]). Pouletty fails to further describe details of the
camera assembly, light assembly, particularly their locations within the medical device relative to the
connection element. Pouletty discloses the magnet to be an external coating on the body part of the
medical device, therefore failing to disclose the magnet to be internal.
However, in the same field of endeavor, Duan teaches a substantially similar system for guiding
a magnetically driven capsule, the system comprising: a magnetically driven capsule defined by: a
camera assembly configured to take images, provide video, or both (imaging system 230 [0068]); a light
assembly configured to illuminate areas surrounding the camera assembly (illumination system include
three or more LEDs 222 [0068]); an internal magnet (one or more magnets 240 [0065]; magnet 640 in
Fig. 6C); an outer covering surrounding the camera assembly, light assembly, and magnet (housing 210
for housing the imaging system 230, an illumination system 220 and magnets 240 [0065]; capsule
endoscope 200 is similar to capsule endoscope 600 [0075]; housing 610 [0076]); wherein the capsule
includes a first end positioned adjacent to the camera assembly and the light assembly (Fig. 6C: distal
illumination system 620b and distal imaging system 630b are adjacent to the first end, the distal end
[0077]), an opposed second end defined by an elongated region with a straight edge adjacent to the
internal magnet, the elongated region and straight edge configured to allow a connection element to
extend from a midpoint of the second end of the capsule (Fig. 6C: tether 720 is attached at the midpoint of proximal end of the capsule; Fig. 9: magnet 640 may be placed toward the proximal end of the
capsule endoscope 600 [0082]), wherein the connection element is configured as a wire to provide power to the camera assembly, provide power to the light assembly, provide a connection to a
computer screen for imaging, or combinations thereof (control signals and image data may be communicated to and from the capsule endoscope through the tether [0061]); an external magnet that exhibits magnetic attraction to the magnet sufficient to guide a location of the magnetically driven
capsule; wherein the external magnet is sufficient to maneuver the capsule via magnetic attraction with
the internal magnet (external control system 2900 may include a spherical magnet 2910 which can
control an external magnetic field to change the orientation or position of internal magnet and the
capsule endoscope [0120]). Since Pouletty fails to disclose the specifics of the camera assembly,
illumination assembly within the capsule, 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 camera assembly and
illumination assembly configuration in a magnetic capsule known in the endoscope art, including the
one taught by Duan. In view of Duan, 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 the internal magnet of
Duan is an equivalent alternative of the magnetic capsule head of Pouletty, as both are the magnetic
component of the capsule inside the body cavity that interacts with the external magnet outside the
patient body to maneuver the capsule through the body cavity.
Regarding claim 11, Pouletty, modified by Duan, discloses the system of claim 10. Duan further
teaches wherein the external magnet is an electromagnet (external control system 2900 may include a spherical magnet 2910, which may be an electromagnet [0120]).
Regarding claim 13, Pouletty, modified by Duan, discloses the system of claim 10. Pouletty
discloses wherein the magnetic part of the medical device is a permanent magnet that remains
magnetized (magnetic head part comprises of neodymium (Nd-Fe-B) magnet [0113], which is known to be a permanent magnet). Duan teaches wherein the internal magnet is a permanent magnet that
remains magnetized (internal magnets may be permanent magnets [0116]).
Regarding claim 14, Pouletty, modified by Duan, discloses the system of claim 10. Pouletty
discloses wherein the magnetic part of the medical device comprises steel, neodymium, samarium cobalt, ceramic, aluminum nickel cobalt, iron, nickel, cobalt, alloy of rare earth metals, lodestone, or
combinations thereof (magnetic head part comprises of neodymium (Nd-Fe-B) magnet [0113], which is
known to be a permanent magnet). Duan teaches wherein the internal magnet comprises steel,
neodymium, samarium cobalt, ceramic, aluminum nickel cobalt, iron, nickel, cobalt, alloy of rare earth
metals, lodestone, or combinations thereof (internal magnets may be rare earth metals such as
neodymium [0116]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pouletty in view of Duan
and Rodriguez-Navarro (US2018/0296289).
Regarding claim 12, Pouletty, modified by Duan, discloses the system of claim 10. Pouletty fails
to disclose the material of the external magnetic field generator. Duan discloses the external magnet to
be a permanent magnet or electromagnet [0120], but fails to specify the magnet material. In the same
field of endeavor, Rodriguez-Navarro teaches a substantially similar magnetically driven capsule,
wherein an external magnet is comprised of neodymium or samarium cobalt (external magnet may be a
permanent magnet which can be comprised of neodymium or samarium cobalt [0072]). Since Pouletty
and Duan fail to disclose the specifics of its external magnet, 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 suitable
external magnet material known in the art, including the one taught by Rodriguez-Navarro, to form the
external magnet.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of
Pouletty.
Regarding claim 15, Duan discloses the method of visualizing a body cavity, the method
comprising: positioning a magnetically driven capsule within a body cavity to be visualized (capsule
endoscope may be advanced into a body cavity such as a GI tract… the imaging system may aid in
navigation [0055]), the magnetically driven capsule defined by: a camera assembly configured to take images, provide video, or both (imaging system 230 [0068]); a light assembly configured to illuminate
areas surrounding the camera assembly (illumination system 220 include three or more LEDs 222
[0068]); an internal magnet (one or more magnets 240 [0065]; magnet 640 in Fig. 6C); an outer covering surrounding the camera assembly, light assembly, and magnet (housing 210 for housing the imaging system 230, an illumination system 220 and magnets 240 [0065]); wherein the capsule includes a first end positioned adjacent to the camera assembly and the light assembly (Fig. 6C: distal illumination system 620b and distal imaging system 630b are adjacent to the first end, the distal end [0077]), an opposed second end defined by an elongated region with a straight edge adjacent to the internal magnet, the elongated region and straight edge configured to allow a connection element to extend from a midpoint of the second end of the capsule (Fig. 6C: tether 720 is attached at the midpoint of proximal end of the capsule; Fig. 9: magnet 640 may be placed toward the proximal end of the capsule endoscope 600 [0082]), wherein the connection element is configured as a wire to provide power to the camera assembly, provide power to the light assembly, provide a connection to a computer screen for imaging, or combinations thereof (control signals and image data may be communicated to and from the capsule endoscope through the tether [0061]); maneuvering the magnetically driven capsule along a desired path using an external magnet positioned on an external surface of the patient's body, wherein the external magnet is sufficient to maneuver the capsule via magnetic attraction with the internal magnet; whereby magnetic attraction between the internal and external magnets guide the path of the capsule (external control system 2900 may include a spherical magnet 2910 which can control an external magnetic field to change the orientation or position of internal magnet and the capsule endoscope [0120]); whereby the body cavity is visualized (imaging system of capsule enables visual assessment of surrounding patient tissue [0060]). Duan fails to disclose wherein the second end of the capsule is a straight edge.
In the same field of endeavor, Pouletty teaches a substantially similar method of visualizing a
body cavity, the method comprising: positioning a magnetically driven capsule within a body cavity
(device is applied to human bodies [0011]), the magnetically driven capsule defined by: a camera
assembly (camera [0036]), and illumination assembly (light signals are transmitted through transmission cable to the medical device [0024]) and a magnet (body part of medical device may comprise a magnetic part to be used to guide the medical device by interaction with an external magnetic field [0035]), wherein the capsule comprises a first distal end (Fig. 6: distal end on the left edge of figure) and an opposed second proximal end defined by an elongated region with a straight edge, the elongated region and straight edge configured to allow a connection element to extend from a midpoint of the second straight end of the capsule (Fig. 6: proximal end, also called tail end 12, comprises a straight edge that allows for connection with controlling line 13 [0155]). In view of Pouletty, 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 capsule endoscopes are known in the art to comprise various shaped ends, including straight flat ends, as taught by Pouletty.
Regarding claim 16, Duan, modified by Pouletty, discloses the method of claim 15. Duan further
discloses wherein the body cavity is selected from the rectum, large intestine, small intestine, or
combinations thereof (capsule endoscope may be advanced into a body cavity such as a GI tract [0055], which includes the rectum, large intestine, and small intestine).
Regarding claim 17, Duan, modified by Pouletty, discloses the method of claim 15. Duan further
discloses wherein the magnetically driven capsule can be maneuvered via the external magnet in a
forward direction, a backward direction, to the right, to the left, rotate, or combinations thereof
(magnets 240 allows for capsule endoscope to be manipulated with 6 degrees of freedom on the three
perpendicular axes [0067]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Pouletty
and Levin (US2014/0316265).
Regarding claim 18, Duan, modified by Pouletty, discloses the method of claim 15, but fails to
disclose wherein the positioning is accomplished by a plastic tubing sized to allow the magnetically
driven capsule to pass therethrough. In the same field of endeavor, Levin teaches a substantially similar
method of visualizing a body cavity using an endoscopic capsule, wherein positioning of the capsule is
accomplished by a plastic tubing sized to allow the capsule to pass therethrough (Fig. 8: capsule 136 can be inserted through a tube in a lumen to reach an area of a body cavity [0164 & 0346]; Fig. 8: rigid
container 104 or straw-like tube 167 is inserted through the rectum, material of container 104/straw-
like tube 167 is typically plastic [0287-0290]). In view of Levin, 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 rigid
container of Levin, to the capsule system of Duan, modified by Pouletty, as it is well known in the art
that the rigid container of Levin helps facilitate the insertion of endoscopic devices, including capsules
and flexible tubes, into the rectum.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of
Pouletty and Kawano (US2017/0150874).
Regarding claim 19, Duan, modified by Pouletty, discloses the method of claim 15. Duan
discloses wherein the magnetic force of the external magnet is applied to the internal magnet at an
angle (internal magnet configured to enable six degrees of freedom, translation and rotation in each of three axes using an external magnetic control system [0117]), but does not specify the angle to be about 15-80 degrees. However, in the same field of endeavor, Kawano teaches an endoscopic capsule that can rotate in various degrees including between 15-80 degrees (capsule endoscope 10 can be rotated to 45 degrees and 60 degrees [0106]). In view of Kawano, it would have been obvious to one of ordinary skill in the art before the effective filing date to have recognized that the capsule of Duan, modified by Pouletty, can rotate any direction or degree, including 15-80 degrees, similarly taught by Kawano, to capture different viewing areas within a body lumen, depending on the body cavity regions required by the operator.
Regarding claim 20, Duan, modified by Pouletty, discloses the method of claim 15. Duan
discloses wherein the magnetic force of the external magnet is applied to the internal magnet at an
angle (internal magnet configured to enable six degrees of freedom, translation and rotation in each of three axes using an external magnetic control system [0117]), but does not specify the angle to be about 30-60 degrees. However, in the same field of endeavor, Kawano teaches an endoscopic capsule that can rotate in various degrees including between 30-60 degrees (capsule endoscope 10 can be rotated to 45 degrees and 60 degrees [0106]). In view of Kawano, it would have been obvious to one of ordinary skill in the art before the effective filing date to have recognized that the capsule of Duan, modified by Pouletty, can rotate any direction or degree, including 30-60 degrees, similarly taught by Kawano, to capture different viewing areas within a body lumen, depending on the body cavity regions required by the operator.
Response to Arguments
Applicant's arguments filed August 26, 2025 and September 10, 2025 have been fully considered but they are not persuasive.
The following is a response to the arguments filed August 26, 2025:
Regarding the 35 U.S.C. 103 rejection of claims 1-11, 13 and 14, Applicant argues that Pouletty discloses expressly requires a tether, thereby teaching away from Applicant’s magnetically maneuvered capsule with no tether. The examiner disagrees. Stated in Pouletty’s paragraph [0159] and seen in Fig. 5, body part 11 of the medical device has a magnetic part 14 which is attracted by the magnetic field 21. The body part 11 of the medical device stays in place, held by the magnetic field against the force of the blood stream, therefore magnetically maneuvering the capsule, while also attached to a controlling line 13. This argument was not persuasive.
Applicant also argues that the controlling line of Pouletty is a retrieval tether and not a wired power/data line. While Applicant has cited paragraph [0059] of Pouletty to evidence this assertion, Pouletty has disclosed an embodiment wherein the controlling line does comprise an energy transmission cable and a data transmission cable [0160]. This argument was not persuasive.
Applicant argues the Pouletty is designed for blood vessels and micro-scale surgical/therapeutic use, and argues that Duan is intended for biopsy and biochemical screening, neither being GI visualization. Claims 1 and claim 10 do not recite any limitation specifying use only for the GI tract, and claims 1 and 10 are apparatus claims, which are examined in view of structure, not intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. This argument was not persuasive.
Applicant also claims that Duan does not disclose a wired tether that transmits power and video as set forth in claims 1 and 10. Examiner disagrees and has cited paragraph [0061] of Duan which teaches wherein control signals and image data may be communicated to and from the capsule endoscope through the tether. This argument was not persuasive.
Applicant argues that neither Pouletty nor Duan teach or suggest a magnetically maneuverable capsule endoscope, however, paragraph [0159] and Fig. 5 of Pouletty discloses the body part 11 of the medical device comprising a magnetic part 14 which is attracted by the magnetic field 21. The body part 11 of the medical device stays in place, held by the magnetic field against the force of the blood stream, therefore magnetically maneuvering the capsule, while also attached to a controlling line 13. In the Duan reference, the capsule endoscope comprises an internal magnet 240 which is controllable by an external magnetic control system, allowing manipulation of the capsule endoscope with 6 degrees of freedom [0067]. This argument was not persuasive.
Applicant argues that the proposed combination of Pouletty and Duan is improper as the modification changes the principle of the operation of a reference, further arguing that the combination replaces the essential tether-based position of Pouletty/Duan with magnetic control. The examiner disagrees, as the combination of Pouletty, in view of Duan, was to teach the specifics of the camera assembly and illumination assembly within the capsule, since Pouletty did not disclose details of the camera assembly and the illumination assembly, and not to replace the tether-based position with magnetic control. Further, both Pouletty and Duan teach tether-based positioning and magnetic maneuverability.
Regarding claim 12, Applicant argues that Rodriguez does not teach a capsule tethered by a wire, rather laparoscopic tools or wireless modules. While examiner agrees that Rodriguez does not teach the tether feature, Rodriguez does teach a capsule comprising a magnetic portion (Fig. 4: capsule 402 comprises magnetic portion 410 [0033]), the capsule capable of being manipulated by an external magnet (magnetic portion 410 is configured to be attracted to a magnetic field [0033]), the external magnet comprise of neodymium or samarium cobalt (external magnets, formed of various suitable material such as neodymium or samarium cobalt, used to generate a magnetic field [0072]). Rodriguez was cited as a teaching reference to cure the deficiencies of Pouletty and Duan, as both references failed to disclose the material of the external magnet. The arguments regarding Rodriguez’s lack of a tether are moot, as Pouletty and Duan both teach the tether feature and the magnetic maneuverability feature, using an internal magnet and an external magnet. Rodriguez was strictly introduced to teach the material of the magnet. Applicant argues that substituting Rodriguez’s magnetic maneuverability into the tether-based device of Pouletty and Duan would destroy the operability of the devices, however Pouletty and Duan individually disclose internal and external magnets for maneuverability of the capsule devices, while also comprising tethers.
Regarding claim 18, applicant argues that Levin does not teach a capsule device and also does not teach wires/fibers through a tether controlling a free capsule, but rather teaches inflatable sleeves for cleansing and imaging. While examiner agrees that Levin does not teach the specifics of a capsule, and does not teach a capsule with a tether, the Levin reference was introduced as a teaching reference to teach a method wherein a capsule is positioned within a body lumen by a plastic tubing sized to allow the capsule to pass therethrough, as required by applicant’s claim 18 (Fig. 8: capsule 136 can be inserted through a tube 10 in a lumen to reach an area of a body cavity [0346]; Fig. 8: rigid container 104 or straw-like tube is inserted through the rectum, material of container 104/straw-like tube 167 is typically plastic [0287-0290]). The arguments regarding Levin’s lack of a tether are moot, as Pouletty and Duan teach the tether feature and the magnetic maneuverability feature, using an internal magnet and an external magnet. Levin was strictly introduced to teach the plastic tubing sized to allow the capsule to pass therethrough.
Regarding claim 19 and 20, Applicant argues that Kawano does not teach wherein the capsule comprises a controlling wire, or is tethered. While the examiner agrees that Kawano does not teach wherein the capsule comprises a controlling wire or is tethered, Kawano was introduced to teach various angles of the magnetic field of the external magnet applied to the internal magnet which allows the capsule can rotate. The arguments regarding Kawano’s lack of a tether are moot, as Pouletty and Duan teach the tether feature and the magnetic maneuverability feature, using an internal magnet and an external magnet. Kawano was strictly introduced to teach wherein a magnetic force of the external magnet is applied to the internal magnet at an angle between 15-80 degrees.
The following is a response to the arguments filed September 10, 2025.
Regarding the rejection of claims 1-11, 13 and 14, applicant argues that Pouletty is a different device than that claimed in claim 1, as Pouletty appears to be limited a microrobot with two parts, a body and a tail. The examiner has interpreted the entire medical device 10, including the body part 11 and tail part 12, to be analogous to applicant’s magnetically drive capsule.
Applicant also argues that Pouletty disclose expressly requires a tether, thereby teaching away from applicant’s magnetically maneuvered capsule with no tether. This is confusing to the examiner, as applicant’s claim 1 and claim 10 both recite “a connection element configured as a wire” which contradicts the statement that applicant’s magnetically maneuvered capsule does not comprise a tether.
Applicant argues that the tether of Pouletty does not transmit data or energy. Examiner has cited paragraph [0160] of Pouletty, which discloses an embodiment wherein the controlling line does comprise an energy transmission cable and a data transmission cable [0160].
Applicant argues that applicant’s capsule is magnetically steered, not tethered, which contrasts Pouletty. As mentioned above, this statement is confusing to the examiner as claim 1 and claim 10 recite “a connection element configured as a wire” which is tethered to the capsule, also seen in Applicant’s Fig. 6. Further, Pouletty also discloses wherein the body part 11 of the medical device has a magnetic part 11 which is attracted by the magnetic field 21. The body part 11 of the medical device stays in place, held by the magnetic field against the force of the blood stream, therefore magnetically maneuvering the capsule, while also attached to a controlling line 13 ([0159], Fig. 5). Therefore, Pouletty’s capsule is also magnetically maneuverable.
Applicant argues that Pouletty excludes cable for continuous power/data, instead only teaching a retrieval tether. While Applicant has cited paragraph [0059] of Pouletty to evidence this assertion, Pouletty has disclosed an embodiment wherein the controlling line does comprise an energy transmission cable and a data transmission cable [0160]. This argument was not persuasive.
Applicant argues the Pouletty is designed for blood vessels and micro-scale surgical/therapeutic use, and argues that Duan is intended for biopsy and biochemical screening, neither being GI visualization. Claims 1 and claim 10 do not recite any limitation specifying use only for the GI tract, and claims 1 and 10 are apparatus claims, which are examined in view of structure, not intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. This argument was not persuasive.
Applicant argues that the tether disclose in Duan is fluidic only, designed for suction/infusion of fluids, and thus not disclose a wired tether that transmits power and video as set forth in claims 1 and 10. Examiner disagrees and has cited paragraph [0061] of Duan which teaches wherein control signals and image data may be communicated to and from the capsule endoscope through the tether. This argument was not persuasive.
Applicant argues that the internal magnet described in Duan’s capsule endoscope needs more than two individual magnets configured to allow six degrees of movement, which is different than Applicant’s imaging capsule that is guided moving along colorectal tract unidirectional by external magnet. Duan’s capsule is also maneuvered using an external magnet, as evidenced in Duan’s paragraph [0067]. Further, Applicant’s imaging capsule also comprises an internal magnet, as claimed in claim 1 and 10. Since both Duan’s capsule and Applicant’s capsule each recite an internal magnet and an external magnet, the examiner is not sure how the capsules are significantly different.
Applicant argues that the proposed combination of Pouletty and Duan is improper as the modification changes the principle of the operation of a reference, further arguing that the combination replaces the essential tether-based position of Pouletty/Duan with magnetic control. The examiner disagrees, as the combination of Pouletty, in view of Duan, was to teach the specifics of the camera assembly and illumination assembly within the capsule, since Pouletty did not disclose details of the camera assembly and the illumination assembly, and not to replace the tether-based position with magnetic control. Further, both Pouletty and Duan each teach tether-based positioning and magnetic maneuverability. The same response to arguments regarding claim 1 applies to the response to arguments of claim 10.
Regarding claim 12, Applicant argues that Rodriguez does not teach a capsule tethered by a wire, rather laparoscopic tools or wireless modules. While examiner agrees that Rodriguez does not teach the tether feature, Rodriguez does teach a capsule comprising a magnetic portion (Fig. 4: capsule 402 comprises magnetic portion 410 [0033]), the capsule capable of being manipulated by an external magnet (magnetic portion 410 is configured to be attracted to a magnetic field [0033]), the external magnet comprise of neodymium or samarium cobalt (external magnets, formed of various suitable material such as neodymium or samarium cobalt, used to generate a magnetic field [0072]). Rodriguez was cited as a teaching reference to cure the deficiencies of Pouletty and Duan, as both references failed to disclose the material of the external magnet. The arguments regarding Rodriguez’s lack of a tether are moot, as Pouletty and Duan teach the tether feature and the magnetic maneuverability feature, using an internal magnet and an external magnet. Rodriguez was strictly introduced to teach the material of the magnet. Applicant argues that substituting Rodriguez’s magnetic maneuverability into the tether-based device of Pouletty and Duan would destroy the operability of the devices, however Pouletty and Duan individually disclose internal and external magnets for maneuverability of the capsule devices, while also comprising tethers.
Regarding claim 18, applicant argues that Levin does not teach a capsule device and also does not teach wires/fibers through a tether controlling a free capsule, but rather teaches inflatable sleeves for cleansing and imaging. While examiner agrees that Levin does not teach the specifics of a capsule, and does not teach a capsule with a tether, the Levin reference was introduced as a teaching reference to teach a method wherein a capsule is positioned within a body lumen by a plastic tubing sized to allow the capsule to pass therethrough, as required by applicant’s claim 18 (Fig. 8: capsule 136 can be inserted through a tube 10 in a lumen to reach an area of a body cavity [0346]; Fig. 8: rigid container 104 or straw-like tube is inserted through the rectum, material of container 104/straw-like tube 167 is typically plastic [0287-0290]). The arguments regarding Levin’s lack of a tether are moot, as Pouletty and Duan teach the tether feature and the magnetic maneuverability feature, using an internal magnet and an external magnet. Levin was strictly introduced to teach the plastic tubing sized to allow the capsule to pass therethrough.
Regarding claim 19 and 20, applicant argues that the claims recite the relative angle of the inner magnet in the imaging capsule with the outer magnet, which guide the moving of the imaging capsule inside the colorectal tract. Applicant notes that the rotation and the angle of the imaging capsule is not of concern, but rather the angle refers to the relative angle of the outside magnet moving/guiding the imaging capsule.
While examiner has understood applicant’s arguments, claim 19 states as recited “wherein the magnetic force of the external magnet is applied to the internal magnet at an angle of about 15-80 degrees.” Claim 20 has been recited similarly, but for the angle 30-60 degrees.
The magnetic field of the external magnet constantly varies in direction, thus the magnetic field applies to the internal magnet at multiple angles, including between 15-80 degrees, depending on the orientation of the internal magnet. Not only does the varying of directions of the magnetic field of the external magnet creates all angles of magnetic force, which varies even more greatly depending on the angle at which the internal magnet is applied, the magnetic force of the external magnet allows for the internal capsule to rotate in all six directions. Further, claims 19 and 20 does not define what the angle is with respect to, thus the examiner had interpreted the claims as such.
For the reasons stated above, applicant’s arguments were not persuasive.
Conclusion
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
10/13/25