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 § 102
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, 2, 5, 6, 11, 13, 16, 22, 25, 29, 31-36, 38 and 40 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Jacobsen et al. (US2014/0371529).
Regarding claim 1, Jacobsen discloses the imaging device (catheter 100) comprising an imaging module configured for image acquisition (imaging device 106), and at least one support element (transparent balloon 122), wherein the support element or at least a part thereof is configured to undergo a change between a deflated configuration to an inflated configuration and vice-versa in response to a change in pressure (inflatable transparent balloon 122, inflated with air, oxygen, saline solution, or other fluid common in the art [0046]), wherein in said deflated configuration the support element is folded onto itself and at least partially covers the imaging module (Fig. 7a: balloon 122, when uninflated, appears to lay flat against the body of the catheter 100, with a first surface of the uninflated balloon 122 laying on a second surface of the uninflated balloon 122; surface of uninflated balloon 122 closely covers the imaging device 106), and in said inflated configuration the support element expands away from the imaging module thereby exposing the imaging module (Fig. 7b: when balloon 122 is inflated, it expands away from the imaging device 106, enlarging to create a distance 103 [0046], thereby exposing the imaging device 106), and wherein said image acquisition is configured to be performed only when the support element or at least a part thereof is in the inflated configuration (the device of Jacobsen is capable of performing image acquisition only when balloon 122 is inflated, especially since the balloon 122 is used as a focal instrument [0046]).
Regarding claim 2, Jacobsen discloses the imaging device according to claim 1, further disclosing wherein the imaging module is at least one of a camera or an optical fiber and wherein the imaging module is configured to be exposed during the image acquisition (imaging device may be a solid-state imaging device SSID which may be a CCD or CMOS [0035-0036]; Fig. 7b: imaging device 106 is capable of performing image acquisition only when balloon 122 is inflated, especially since the balloon 122 is used as a focal instrument [0046] when balloon 122 is inflated and it expands away from the imaging device 106, enlarging to create a distance 103 [0046], thereby exposing the imaging device 106).
Regarding claim 5, Jacobsen discloses the imaging device according to claim 1, further disclosing wherein the device is configured to allow a direct transmission of light from a tissue to the imaging module (inflated balloon 122 is transparent, also acting as a focal instrument to that imaged objects that come into contact with the outer periphery of the balloon are substantially in focus [0045-0046]).
Regarding claim 6, Jacobsen discloses the imaging device according to claim 1, further disclosing wherein the support element or any part thereof is any one of (a) configured to allow at least one of (i) flow of gas and/or fluids and/or air to an imaged tissue, (ii) flow of gas and/or fluids through an imaged tissue and surroundings, and (iii) drainage or gas/fluid supply from and to the tissue; (b) is a membrane or a balloon; or (c) is or comprises an elastic material ((b) balloon 122 is a balloon/membrane).
Regarding claim 11, Jacobsen discloses the imaging device according to claim 1, further disclosing the device comprising at least one illumination means, optionally comprising at least one selected from the group consisting of a light-emitting diode (LED), a laser, and an optical fiber (light emitting diodes LEDs may be used for providing light to areas around imaging device 106 [0035]).
Regarding claim 13, Jacobsen discloses the imaging device according to claim 1, further disclosing the device comprising a delivery member, optionally the delivery member being in a form of a shaft, handle or catheter (catheter 100 is a delivery member) and the delivery member is configured to undergo association and/or dissociation (catheter 100 is capable of undergoing association and/or dissociation).
Regarding claim 16, Jacobsen discloses the imaging device according to claim 1, further disclosing a pressure system coupled with the at least one support element (inflatable balloon is attached to fluid source for inflation and deflation [0043]).
Regarding claim 22, Jacobsen discloses a method of imaging a body cavity in a subject, the method comprising introducing an imaging device into a body cavity of a subject (claim 13: inserting catheter into cavity of patient), wherein said imaging device comprises an imaging module configured for image acquisition (imaging device 106) and at least one support element (transparent balloon 122) configured to undergo a change between a deflated configuration in which the support element is folded into itself and at least partially covers the imaging module (Fig. 7a: balloon 122, when uninflated, appears to lay flat against the body of the catheter 100, with a first surface of the uninflated balloon 122 laying on a second surface of the uninflated balloon 122; surface of uninflated balloon 122 closely covers the imaging device 106) and an inflated configuration in response to a change in pressure (inflatable transparent balloon 122, inflated with air, oxygen, saline solution, or other fluid common in the art [0046]); positioning said imaging device in the body cavity while the support element or at least a part thereof is in the deflated configuration such that the support element or at least a part thereof at least partially covers the imaging module (distal end of catheter 100, with the deflated balloon 122, is positioned inside body lumen while deflated balloon 122 closely covers the imaging device 106, as shown in Fig. 7a [0046]); inflating the support element to the inflated configuration wherein said inflating causes the support element to expand away from the imaging module, thereby exposing so that the imaging module is exposed (Fig. 7b: balloon 122 is inflated, balloon 122 expands forward and laterally from the optical axis of the imaging device 106; Fig. 7b: when balloon 122 is inflated, it expands away from the imaging device 106, enlarging to create a distance 103 [0046], thereby exposing the imaging device 106); and monitoring a signal and acquiring an image of at least one body cavity in the subject (image can be captured using imaging device [0035]), wherein said image acquisition is only while the support element is in the inflated configuration (the device of Jacobsen is capable of performing image acquisition only when balloon 122 is inflated, especially since the balloon 122 is used as a focal instrument [0046]).
Regarding claim 25, Jacobsen discloses the method according to claim 22, further disclosing wherein the body cavity is at least one of heart, lungs, liver, kidney, stomach and intestines, thymus, pancreas, skin, bone, bone marrow, vascular system, lymph, lymph node, uterus, bladder, fallopian tubes, a joint or ovaries (can be used within a bodily passage for example, the lungs, veins or GI tract [0034]).
Regarding claim 29, Jacobsen discloses the method according to claim 22, further disclosing the method comprising applying pressure such that the at least one support element is inflated along a longitudinal optical axis until it is in contact with tissue (distal end of catheter 100 occludes the passage of fluids through the vessel of the patient [0046], highly suggestive that the balloon 122 is inflated to contact the walls of the bodily passage, as shown in Fig. 7b [0041]; outer periphery of transparent focal instrument can be placed in contact with bodily tissue [0033]).
Regarding claim 31, Jacobsen discloses the method according to claim 29, further disclosing the method comprising inflating the support element perpendicular to a longitudinal optical axis until it is in contact with the tissue (Fig. 6b and 7b: inflatable balloon 122 is inflated, and expands forward and perpendicularly to the optical axis of the imaging device 106 until inflatable balloon 122 contacts the walls of the bodily passage [0046]).
Regarding claim 32, Jacobsen discloses the method according to claim 22, further disclosing the method comprising allowing the at least one support element to be inflated by using gas or liquid (inflatable transparent balloon 122, inflated with air, oxygen, saline solution, or other fluid common in the art [0046]).
Regarding claim 33, Jacobsen discloses the method of claim 22, further disclosing wherein the imaging device is configured to allow a direct transmission of light from a tissue to the imaging module (inflated balloon 122 is transparent, also acting as a focal instrument to that imaged objects that come into contact with the outer periphery of the balloon are substantially in focus [0045-0046]).
Regarding claim 34, Jacobsen discloses the method of claim 22, further disclosing wherein the support element or any part thereof is any one of: (a) configured to allow at least one of (i) flow of gas and/or fluids and/or air to an imaged tissue, (ii) flow of gas and/or fluids through an imaged tissue and surroundings, and (iii) drainage or gas/fluid supply from and to the tissue; (b) is a membrane or a balloon; or (c) is or comprises an elastic material ((b) balloon 122 is a balloon/membrane).
Regarding claim 35, Jacobsen discloses the method of claim 22, wherein the imaging device comprises a delivery member, optionally the delivery member being in a form of a shaft, handle, or catheter (catheter 100 is a delivery member), wherein the delivery member is configured to undergo association and/or dissociation (catheter 100 is capable of undergoing association and/or dissociation).
Regarding claim 36, Jacobsen discloses the method of claim 22, further disclosing wherein the signal is indicative of a condition or disease, thereby diagnosing the condition or the disease in the subject (image, coming from the imaging device 106 in the form of a signal, may be viewed to indicate to an operator the condition of the body cavity, thereby diagnosing the condition [0035]).
Regarding claim 38, Jacobsen discloses the imaging device according to claim 1, further disclosing wherein the support element or at least a part thereof is configured to undergo a change between a deflated configuration, in which the support element at least partially covers the imaging module (Fig. 7a: balloon 122 is in the deflated configuration and closely covers the imaging device 106), and an inflated configuration, in which at least a lens of the imaging module is exposed, in response to the change in pressure (when balloon 122 is inflated and it expands away from the imaging device 106, enlarging to create a distance 103 [0046], thereby exposing the imaging device 106; imaging device can include various camera and lens devices [0035]).
Regarding claim 40, Jacobsen discloses the device of claim 1, further disclosing wherein inflation of the support element stabilizes the imaging module against tissue, providing a free optical axis (balloon 122 can form a transparent focal instrument [0046], which can be pressed against the walls of the bodily lumen to stabilize the distal end of catheter 100, providing an unobstructed optical axis for imaging; distal end of catheter 100 may occlude the passage of fluids through the vessel of the patient [0046], highly suggestive that the inflatable balloon 122 may be pressed against tissue or the walls of the bodily lumen).
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen in view of Tilson et al. (US2013/0190796).
Regarding claim 17, Jacobsen discloses the imaging device according to claim 16. While Jacobsen discloses a pressure system coupled with the at least one support element, Jacobsen fails to explicitly disclose a tube network configured to allow transfer of fluid and/or gas and/or air from the pressure system to the at least one support element. In the same field of endeavor, Tilson teaches an imaging device comprising at least one support element (balloon 20 [0140]), wherein the support element is configured to undergo a change between a deflated configuration to an inflated configuration and vice-versa in response to a change in pressure (placing fluid in balloon volume 24 may cause balloon to inflate [0144]), the imaging device further comprising a pressure system coupled with the at least one support element (inflation system [0140]) and a tube network configured to allow transfer of fluid and/or gas and/or air from the pressure system to the at least one support element (hollow shaft connected to the inflation system to deliver a fluid pressure to the balloon 20 [0140]). In view of Tilson, 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 tube network of Tilson, to the device of Jacobsen, as it is a known structure in the endoscope art for delivering fluid between a pressure system and a support element for inflation and deflation.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen in view of Harpaz et al. (US2018/0207409).
Regarding claim 37, Jacobsen discloses the method according to claim 36, but fails to disclose
wherein the condition or the disease is associated with uterus (endometrium) status. In the same field
of endeavor, Harpaz teaches a same method of imaging a body cavity including applying an imaging
device to a subject in need thereof and monitoring a signal from at least one body cavity in the subject
(cervical dilation device 10 is inserted into the cervical canal [0046] and uterus [0048], camera 40
projects to screen 44 so medical team can easily navigate body cavity [0048 & 0054]), wherein the
imaging device comprises an imaging module (wired camera 40 [0047]) and at least one support
element (balloons 22, 16, and 14), wherein the support element or any part thereof is configured to
undergo inflation in response to a change in pressure (balloons 22, 16, and 14 are inflated by injection of saline or other fluid up to approximately 6 atmospheres [0052]). Although Jacobsen does not specify applying its method of imaging a body cavity to a uterus, in view of Harpaz 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 method of imaging a body cavity as taught by Jacobsen can be used to image a uterus, as taught by Harpaz.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 22 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. Upon further consideration, a new ground(s) of rejection is made in view of Jacobsen.
The examiner would like to direct applicant’s attention to Figure 14C and paragraph [0143] of Saadat ‘457, which is another embodiment or interpretation of this prior art that may still read on applicant’s independent claims.
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
05/04/2026
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