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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, Species A, claims 1-12 in the reply filed on December 24, 2025 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 24, 2025.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Truckai (US 20150105791).
Regarding claim 1, Truckai discloses a medical system comprising: a device for removing an object in a body cavity, the device including: a shaft portion (115) including a rotatable drive shaft (190) and a lumen (sleeve, paragraph 0042), a motor (148) configured to rotate the drive shaft (190), a cutter (126) attached to a distal end of the drive shaft and configured to cut the object when the drive shaft is rotated by the motor, and a pump operable according to one or more parameters to create a vacuum in the lumen to transport the cut object through the lumen; one or more sensors (302, 304) each configured to detect a physical quantity related to the cut object transported through the lumen (capacitance reading); and a controller (210) configured to: determine the parameters based on the physical quantity detected by each of the sensors, and control the pump to create the vacuum in the lumen according to the determined parameters (paragraph 0037).
Regarding claim 2, Truckai discloses all of the limitations set forth in claim 1, wherein one of the parameters indicates a suction force of the vacuum created by the pump (modulate negative pressure source, paragraph 0037).
Regarding claim 3, Truckai discloses all of the limitations set forth in claim 1, wherein one of the sensors detects, during a time period the vacuum is created in the lumen (paragraph 0037): a hardness of a piece of the cut object that is transported through the lumen (paragraph 0037, capacitance sensor senses the density of tissue).
Regarding claim 10, Truckai discloses all of the limitations set forth in claim 1, wherein the controller is further configured to: determine whether the physical quantity detected by one of the sensors is within a predetermined range (tissue contact or no tissue contact, paragraph 0037), upon determining that the physical quantity is within the predetermined range (in contact with tissue), determine not to change the parameters (maintain suction force), and upon determining that the physical quantity is not within the predetermined range (not in contact with tissue), determine to change the parameters and update the parameters based on the physical quantity (de-activate negative pressure source).
Regarding claim 11, Truckai discloses all of the limitations set forth in claim 1, wherein the controller is further configured to control the motor to stop before stopping the pump (paragraph 0036, pump still activated while motor stops reciprocation).
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US 20150105791) as applied to claim 1 above, and further in view of Lastarria (US 9956040).
Regarding claim 4, Truckai discloses all of the limitations set forth in claim 1, wherein Truckai further discloses a liquid flowing through the lumen during a time period the vacuum is created in the lumen (paragraph 0035, 0042) and wherein one of the parameters indicates a suction force of the vacuum created by the pump (paragraph 0035, 0037, negative pressure), but does not specifically disclose one of the sensors detects a flow rate of the liquid, and that controller controls the pump to increase the suction force in response to the flow rate falling below a threshold. Lastarria teaches a surgery system with providing a irrigation flow sensor to monitor the flow of the irrigation fluid during surgery (C:5, L:61-67), wherein the controller controls a pump to increase the suction (suction pump activated) to enhance the flow of the liquid (C:6, L:32-45) when the flow rate falls below a threshold, which can indicated blockage (C:6, L:13-15), to regulate the flow of the liquid within the lumen. Therefore, it would have been within the skill of one with ordinary skill in the art at the time of the invention to include a irrigation control mechanism comprising a sensor to detect a flow rate of the liquid, in the device of Truckai, and work with the controller to control the pump to increase the suction force in response to the flow rate falling below a threshold, as taught by Lastarria, in order to maintain and regulate sufficient flow of the liquid within the lumen for expelling tissue.
Regarding claim 5, Truckai in view of Lastarria teaches all of the limitations set forth in claim 4, wherein Lastarria further teaches presetting a proper flow rate range (C:4, L:56-61) and using the controller and pump to regulate the flow accordingly (C:6, L:49-53). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the controller regulate the flow according to the preset proper flow rate range, such that the pump to stops creating the vacuum when the flow rate continues to change over a predetermined time, in order to regulate the flow and maintain a proper and desired flow rate of the liquid.
Claims 7 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US 20150105791) as applied to claim 1 above, and further in view of Kadziauskas et al (US 20060084961).
Regarding claim 7, Truckai discloses all of the limitations set forth in claim 1, wherein one of the parameters indicates a suction force of the vacuum created by the pump (paragraph 0035, 0037, negative pressure), but does not specifically disclose one of the sensors detects an amount of negative pressure applied to the lumen during a time period the vacuum is created in the lumen, and the controller controls the pump to increase the suction force in response to the amount of negative pressure rising above a threshold. Kadziauskas et al (hereafter Kadziauskas) discloses a cutting device with an aspiration mechanism having pressure controlling system, wherein it was known in the art at the time of the invention to have a sensor detecting negative pressure applied to the aspiration lumen during a time period the vacuum is created in the lumen (57), wherein it was known in the art at the time of the invention for the controller of the system to control the pump to increase suction force in response to the amount of negative pressure rising above a threshold in order to clear an occlusion detected in the lumen and maintain aspiration (paragraphs 0048-0050). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to further have the controller of Truckai have a sensor to detect an amount of negative pressure applied to the lumen during a time period the vacuum is created in the lumen, and the controller controls the pump to increase the suction force in response to the amount of negative pressure rising above a threshold, as taught by Kadziauskas, in order to clear an occlusion detected in the lumen and maintain aspiration.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US 20150105791) in view of Kadziauskas et al (US 20060084961), as applied to claim 7 above, and further in view of Haines (US 4935005).
Regarding claim 8, Truckai in view of Kadziauskas teaches all of the limitations set forth in claim 7, but does not specifically teach after increasing the suction force, the controller controls the pump to stop creating the vacuum when the amount of negative pressure continues to change over a predetermined time. However, Haines teaches it was known in the art at the time of the invention to eliminate occlusions by controlling a pump to stop creating vacuum when the amount of negative pressure continues to change over a predetermined time (predetermined level) after increasing the suction force (C:4, L:41-50; C:6, L:53-55) in order to alert an operator of the occurrence of a blockage. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to control the pump to stop creating the vacuum when the amount of negative pressure continues to change over a predetermined time after increasing the suction force to alert of a blockage and clear an occlusion from the lumen.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US 20150105791) as applied to claim 1 above.
Regarding claim 12, Truckai discloses all of the limitations set forth in claim 1, further comprising: another pump configured to supply a liquid into the body cavity through the shaft portion (260, pressurized fluid source, paragraph 0008, paragraph 0033), wherein the controller is further configured to: determine whether the physical quantity detected by one of the sensors is within a predetermined range (paragraph 0037, tissue detected or not detected based on capacitance reading). Truckai does not teach controlling the another pump to supply the liquid is specifically upon determining that the physical quantity related to the cut object exceeds the predetermined range. However, Truckai does teach controlling the pressurized fluid source in response to signals from a sensor (paragraph 0036) to push a captured tissue chip through the extraction lumen. It would have been within the skill of one with ordinary skill in the art at the time of the invention alternatively control the another pump to supply liquid based on the one or more sensors configured to detect a physical quantity exceeding the predetermined range (in contact with tissue) as an alternative means to sense when the cutting sleeve is engaging tissue and supply liquid to the lumen.
Allowable Subject Matter
Claims 6 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art teaches all of the limitations set forth in claims 4 and 7, no reference could be found that teaches the limitations in claim 4 in combination with having another one of the sensors detects a size of a piece of the cut object that is transported through the lumen, and after increasing the suction force, the controller controls the pump to continue to create the vacuum even when the flow rate or amount of negative pressure continues to change over a predetermined time if the size of a piece of the cut object exceeds a reference value, since there is no teaching, suggestion, or motivation to produce the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/Primary Examiner, Art Unit 3771