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 Group III in the reply filed on 5/5/2026 is acknowledged.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 26 and 41-44 are rejected under 35 U.S.C. 103 as being unpatentable over Chandanson et al., US 12458367, herein referred to as “Chandanson”, in view of Keast et al., US 20100312141, herein referred to as “Keast”.
Regarding claim 26, Chandanson discloses an apparatus (Figure 8A), comprising: a housing defining an inner volume (Figures 8A-B: adapter 100”’); an actuator disposed on the housing and coupled to a tubular member (Figures 8A-B: drill 12 and Co. 16, lines 18-22), the actuator configured to cause the tubular member to rotate distally through tissue (Col. 16, lines 10-22 and Col. 7, lines 54-57); a locking mechanism at least partially disposed in the housing (Figure 8B: brake mechanism 140), the locking mechanism in a locked configuration configured to prevent movement of the actuator (Col. 16, lines 28-41), the locking mechanism configured to transition from an unlocked configuration to the locked configuration when a distal end of the tubular member is at a predetermined depth relative to a tissue (Claim 29 and Col. 4, lines 17-28); and a shaft configured to extend through the inner volume of the housing such that a portion of the shaft is slidably disposed through a portion of the locking mechanism (Figure 8B: drill bit 200), the shaft coupled to a tissue anchor configured to anchor to a target tissue site in the lung (Col. 7, lines 55-57), the shaft configured to engage with the portion of the locking mechanism when the distal end of the tubular member is at the predetermined depth, to transition the locking mechanism to the locked configuration (Col. 16, lines 23-49). Chandanson does not explicitly disclose an apparatus wherein the tissue is tissue of a lung. However, Keast teaches an apparatus wherein the tissue is tissue of a lung ([0043]: “In the case where the device is used in the lungs, limiting the stroke length of the core device also reduces the chance that the device will breach the lungs or pleural membrane.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that the tissue is tissue of a lung as taught by Keast to obtain a sample of tissue using a minimally invasive approach to access remote areas of the body (Keast [0014]).
Regarding claim 41, Chandanson in view of Keast discloses the apparatus of claim 26, and Chandanson further discloses an apparatus wherein the tubular member is configured to be disposed over the shaft, the shaft configured to guide the tubular member toward the target tissue site (Figure 8B: drill bit 202 is disposed over a shaft and Col. 10, lines 10-13).
Regarding claim 42, Chandanson in view of Keast discloses the apparatus of claim 26, and Chandanson further discloses an apparatus wherein the locking mechanism includes an indicator configured to indicate to an operator that the shaft has engaged the locking mechanism and transitioned the locking mechanism to the locked configuration (Col. 16, lines 28-41; wherein the stopping of surgical drill 12 is an indicator).
Regarding claim 43, Chandanson in view of Keast discloses the apparatus of claim 26, and Chandanson further discloses an apparatus wherein after the tissue anchor and the target tissue site are disposed within an inner volume of the tubular member, the locking mechanism is configured to transition from the locked configuration to the unlocked configuration (Col. 16, lines 41-49).
Regarding claim 44, Chandanson in view of Keast discloses the apparatus of claim 26, and Chandanson further discloses an apparatus wherein the shaft includes a groove configured to engage with the portion of the locking mechanism when the distal end of the tubular member is at the predetermined depth (Col. 16, lines 23-49 and Figure 8B: brake mechanism 140 and Col. 16, lines 25-27).
Claims 27-32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Chandanson in view of Keast, further in view of Garrison, US 20130103030, herein referred to as “Garrison”.
Regarding claim 27, Chandanson in view of Keast discloses the apparatus of claim 26, but does not explicitly disclose an apparatus wherein the tubular member is a first tubular member including a first electrode on a distal end thereof, the apparatus further comprising: a second actuator coupled to a second tubular member including a second electrode on a distal end thereof, the second actuator configured to apply a first force to the second tubular member to move the second tubular member distally to clamp a portion of tissue between the first electrode and the second electrode, the first electrode and the second electrode configured to be activated with energy to seal vessels in the portion of tissue.
However, Garrison teaches an apparatus (Figures 5A-B) wherein the tubular member is a first tubular member including a first electrode on a distal end thereof (Figure 5B: lower jaw member 520 and electrically conductive sealing surface 512b), the apparatus further comprising: a second actuator (Figure 5A: movable handle 540 and [0086]) coupled to a second tubular member including a second electrode on a distal end thereof (Figure 5B: upper jaw member 510 and electrically conductive sealing surface 512a), the second actuator configured to apply a first force to the second tubular member to move the second tubular member distally to clamp a portion of tissue between the first electrode and the second electrode ([0086]), the first electrode and the second electrode configured to be activated with energy to seal vessels in the portion of tissue ([0085]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that the tubular member is a first tubular member including a first electrode on a distal end thereof, the apparatus further comprising: a second actuator coupled to a second tubular member including a second electrode on a distal end thereof, the second actuator configured to apply a first force to the second tubular member to move the second tubular member distally to clamp a portion of tissue between the first electrode and the second electrode, the first electrode and the second electrode configured to be activated with energy to seal vessels in the portion of tissue as taught by Garrison so that a surgeon can either cauterize, coagulate/desiccate, reduce or slow bleeding and/or seal vessels by controlling the intensity, frequency and duration of the electrosurgical energy applied to the tissue (Garrison [0005]).
Regarding claim 28, Chandanson in view of Keast and Garrison discloses the apparatus of claim 27, and Garrison further discloses an apparatus further comprising: a third actuator coupled to a cutting device (Figure 5A: 570 and [0045]), the third actuator when actuated configured to apply a second force to the cutting device to cause the cutting device to advance through the portion of tissue and cut the portion of tissue (Figure 5A: knife 585 and [0089]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that it includes a third actuator coupled to a cutting device, the third actuator when actuated configured to apply a second force to the cutting device to cause the cutting device to advance through the portion of tissue and cut the portion of tissue as taught by Garrison so that a surgeon can either cauterize, coagulate/desiccate, reduce or slow bleeding and/or seal vessels by controlling the intensity, frequency and duration of the electrosurgical energy applied to the tissue (Garrison [0005]).
Regarding claim 29, Chandanson in view of Keast and Garrison discloses the apparatus of claim 27, and Garrison further discloses an apparatus further comprising a mode button ([0112]), the mode button is configured to cause the second tubular member to withdraw proximally to expose a snare near a distal end of the second tubular member (Figures 11A-B and [0114]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that it includes a mode button, the mode button is configured to cause the second tubular member to withdraw proximally to expose a snare near a distal end of the second tubular member as taught by Garrison to deliver electrosurgical energy and coagulate, cauterize and/or ablate the target tissue adjacent the device (Garrison [0117]).
Regarding claim 30, Chandanson in view of Keast and Garrison discloses the apparatus of claim 29, and Garrison further discloses an apparatus wherein the portion of tissue is a first portion of tissue (Figures 11A-B), the apparatus further comprising: a snare actuator configured to be moved to a first position to cause the snare to move a second portion of tissue toward the first electrode and the second electrode ([0112]), the snare actuator configured to be moved to a second position to cause the snare to sever the second portion of tissue from surrounding tissue (Figures 11A-B and [0114]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that it includes a snare actuator configured to be moved to a first position to cause the snare to move a second portion of tissue toward the first electrode and the second electrode, the snare actuator configured to be moved to a second position to cause the snare to sever the second portion of tissue from surrounding tissue as taught by Garrison to deliver electrosurgical energy and coagulate, cauterize and/or ablate the target tissue adjacent the device (Garrison [0117]).
Regarding claim 31, Chandanson in view of Keast and Garrison discloses the apparatus of claim 28, and Garrison further discloses an apparatus wherein the second tubular member and the cutting device are connected at a proximal end (Figure 5A: knife 585 and knife channel 515a), the second actuator is configured to apply the first force to the proximal end (Figure 5A: movable handle 540 and [0086]), and the third actuator is configured to provide the second force to the proximal end (Figures 11A-B and [0112] and [0114]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that the second tubular member and the cutting device are connected at a proximal end, the second actuator is configured to apply the first force to the proximal end, and the third actuator is configured to provide the second force to the proximal end as taught by Garrison so that a surgeon can either cauterize, coagulate/desiccate, reduce or slow bleeding and/or seal vessels by controlling the intensity, frequency and duration of the electrosurgical energy applied to the tissue (Garrison [0005]).
Regarding claim 32, Chandanson in view of Keast and Garrison discloses the apparatus of claim 31, and Keast further discloses an apparatus wherein the second force is greater than the first force (Col. 7, lines 38-53; in combination with Garrison, the second force is performed by the motor of the drill, this it is greater than the clamping force of Garrison, the first force).
Regarding claim 35, Chandanson in view of Keast discloses the apparatus of claim 26, but does not explicitly disclose an apparatus wherein the actuator includes a wheel configured to rotate a shaft to cause the tubular member to rotate distally through the tissue.
However, Garrison teaches an apparatus wherein the actuator includes a wheel configured to rotate a shaft to cause the tubular member to rotate distally through the tissue (Figure 5A: rotating assembly 580 and [0082]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that the actuator includes a wheel configured to rotate a shaft to cause the tubular member to rotate distally through the tissue as taught by Garrison to allow for flexibility in grasping and sealing of tissue (Garrison [0050]).
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Chandanson in view of Keast and Garrison, further in view of Jimenez et al., US 20130338706, herein referred to as “Jimenez”.
Regarding claim 33, Chandanson in view of Keast and Garrison discloses the apparatus of claim 31, but does not explicitly disclose an apparatus wherein a portion of the second tubular member includes a plurality of cut outs such that the portion of the second tubular member is compliant along a longitudinal axis thereof.
However, Jimenez teaches an apparatus (Figure 3E) wherein a portion of the second tubular member includes a plurality of cut outs such that the portion of the second tubular member is compliant along a longitudinal axis thereof (Figure 3E: penetration depth indicator element 235).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that a portion of the second tubular member includes a plurality of cut outs such that the portion of the second tubular member is compliant along a longitudinal axis thereof as taught by Jimenez to indicate the depth of the device in tissue (Jimenez [0052]).
Regarding claim 34, Chandanson in view of Keast, Garrison, and Jimenez discloses the apparatus of claim 33, and Jimenez further discloses an apparatus wherein the second force applied to the proximal end is configured to cause the portion of the second tubular member to compress along the longitudinal axis (Figure 3E: penetration depth indicator element 235).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that the second force applied to the proximal end is configured to cause the portion of the second tubular member to compress along the longitudinal axis as taught by Jimenez to indicate the depth of the device in tissue (Jimenez [0052]).
Claims 36-40 are rejected under 35 U.S.C. 103 as being unpatentable over Chandanson in view of Keast, further in view of Cohn et al., US 20200038089, herein referred to as “Cohn”.
Regarding claim 36, Chandanson in view of Keast discloses the apparatus of claim 26, but does not explicitly disclose an apparatus wherein the tubular member includes a helical coil coupled to a distal end thereof, the helical coil including a first electrode thereon.
However, Cohn teaches an apparatus (Figure 2) wherein the tubular member includes a helical coil coupled to a distal end thereof (Figure 2: coil 1110), the helical coil including a first electrode thereon (Figure 2: electrode 1130 and [0030]: “An electrode 1130 is disposed on a surface or embedded within coil 1110.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that the tubular member includes a helical coil coupled to a distal end thereof, the helical coil including a first electrode thereon as taught by Cohn so that during a lung biopsy, the whole lesion is removed in one single procedure so that an accurate diagnosis may be performed (Cohn [0012]).
Regarding claim 37, Chandanson in view of Keast and Cohn discloses the apparatus of claim 36, and Cohn further discloses an apparatus further comprising: a second actuator configured to advance a second electrode toward the helical coil to clamp a portion of tissue between the first electrode and the second electrode (Figure 2 and [0032]: “Central tube 1200 may be advanced through the tissue clamping zone towards coil 1110 such that electrode 1205 abuts electrode 1130.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that it includes a second actuator configured to advance a second electrode toward the helical coil to clamp a portion of tissue between the first electrode and the second electrode as taught by Cohn so that during a lung biopsy, the whole lesion is removed in one single procedure so that an accurate diagnosis may be performed (Cohn [0012]).
Regarding claim 38, Chandanson in view of Keast and Cohn discloses the apparatus of claim 37, and Cohn further discloses an apparatus further comprising: a third actuator coupled to a cutting device and configured to cause the cutting device to advance through the portion of tissue to cut the portion of tissue ([0033] and [0034]: “Once blood vessels are sealed, cutting tube 1300 is advanced to core the tissue to the depth that outer tube 1105 has reached.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that it includes a third actuator coupled to a cutting device and configured to cause the cutting device to advance through the portion of tissue to cut the portion of tissue as taught by Cohn so that during a lung biopsy, the whole lesion is removed in one single procedure so that an accurate diagnosis may be performed (Cohn [0012]).
Regarding claim 39, Chandanson in view of Keast and Cohn discloses the apparatus of claim 38, and Cohn further discloses an apparatus further comprising a mode button, the mode button is configured to lock the third actuator to prevent the cutting device from being advanced after the tissue anchor and the target tissue site are disposed within an inner volume of the tubular member ([0034] and [0021]: “A cutting tube includes a cutting edge slidably disposed within the central tube and the cutting tube is configured to advance at least as far as one of the coil segments.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Chandanson so that it includes a mode button, the mode button is configured to lock the third actuator to prevent the cutting device from being advanced after the tissue anchor and the target tissue site are disposed within an inner volume of the tubular member as taught by Cohn so that during a lung biopsy, the whole lesion is removed in one single procedure so that an accurate diagnosis may be performed (Cohn [0012]).
Regarding claim 40, Chandanson in view of Keast and Cohn discloses the apparatus of claim 38, but does not explicitly disclose an apparatus wherein at least one of the second actuator or the third actuator is a lever.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to use a lever, since applicant has not disclosed that the actuator specifically being a lever solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a slider, knob, wheel, or crank, as a lever and a slider, knob, wheel, or crank are equivalent in the art as taught by paragraph [0156] of Zarins et al., US 20180110554.
Conclusion
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/NORA W RHODES/Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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