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 .
Status of Claims
Claims 1-10 and 12-21 are currently pending and under examination. Claim 11 is canceled. As per the amendments filed on 02/13/2026, claims 1, 6-8, 12, and 19-20 are amended. Claim 21 is newly added.
Priority
The instant application (filed on 03/03/2023) is a non-provisional application filed under 35 USC 111(a). Acknowledgment is made of Applicant's claim for domestic priority based on provisional application 63/317,286 (filed on 03/07/2022). Amended instant claims 1-10 and 12-21 are sufficiently described in the provisional application to receive an effective filing date of 03/07/2022 for the instant application. Therefore, all prior art will be evaluated with respect to this date.
Response to Arguments
Applicant's arguments, (Claim Rejections - 35 USC § 112(b)), filed 02/13/2026, with respect to the rejection of Claim 10 under 35 USC § 112(b) have been fully considered. The limitation “the first end includes elastic” is amended to include “elastic member” to specify what is elastic. Therefore, the rejection of claim 10 is withdrawn.
Applicant's arguments, see Remarks page 11 (Claim Rejections - 35 USC § 103), filed
02/13/2026, with respect to the rejections of Claims 1-20 under 35 USC § 103 have been fully considered. Claim 11 is canceled. Applicant argues:
Applicant appreciates the courtesies extended during the telephonic interview with the Examiner on February 10, 2026. The claims were amended as discussed in the interview. Applicant appreciates the Examiner's indication during the interview that the present amendments appeared to overcome the rejections in the pending Office Action. With respect to claim 19, Applicant submits that Cookson (US 201710190050) is silent in both discussion and suggestion of a tool plate 150 that comprises portions that are "releasably coupled to each other prior to deployment from a frame assembly in a packaged configuration and de-coupled from each other in a deployed configuration" per claim 19, as amended, despite its ability to be connected to two end effectors simultaneously. Applicant acknowledges that the Examiner reserved the right to update or supplement the Examiner's search.
To the extent that the amendments constitute a narrowing of the claims, such narrowing of the claims should not be construed as an admission as to the merits of the prior rejections. To the extent that any particular statement or argument by the Office in the pending Office Action has not been explicitly addressed herein, this should not be construed as an admission by the Applicant that such statements or arguments by the Office are accurate or proper. (02/13/2026 Remarks, Page 11)
This argument is persuasive. Therefore, the rejections of claims 1-10 and 12-20 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made newly in view of Karguth (US 2016/0151115 A1) and Anderson (US 7699855 B2). Newly added claim 21 is evaluated in light of the argument above.
Summary: The 35 U.S.C. § 103 rejections for claims 1-10 and 12-20 are withdrawn. New 35 U.S.C. § 103 rejections are added for claims 1-10 and 12-20. A 35 U.S.C. § 103 rejection is added for newly added claim 21.
Claim Rejections - 35 USC § 103
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-6, 9, 12-13, and 15-18 are rejected under U.S.C 103 as being unpatentable over Choi (KR 20110057108 A1) in view of Ueda (US 2018/0280101 A1), Arco (US 4,627,427) (all cited previously), and Karguth (US 2016/0151115 A1). Note a machine translation via Espacenet (https://worldwide.espacenet.com) is used to interpret the disclosure in Choi - see attached for copy of translation.
Regarding Claim 1, Choi discloses an assembly comprising:
• (a) a first sterile adapter configured to be received by a first movable robotic arm of a robotic surgical system (Page 5 (translation): “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter”);
• (b) a sterile drape that includes a first sleeve configured to extend over the first movable robotic arm (Fig. 5, [0080] – each arm can be draped via a sleeve), the first sleeve comprising:
(i) a first end coupled with the first sterile adapter (Page 7 (translation): “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter, and a sterile drape can have an opening hole perforated corresponding to a position where the sterile adapter is mounted. In this case, an adhesive portion may be formed on the outer periphery of the open hole to allow a sterile adapter to be attached”).
• (c) a frame assembly (Figs. 6-7 – could be the frame elements in Choi’s robotic arm assembly since the any structural frame could conceivable by the frame assembly)
Choi does not disclose (b)(ii) a second end disposed opposite the first end, wherein the first end is inverted toward the second end, and (b)(iii) an intermediate portion disposed between the first and second ends, wherein the intermediate portion includes a first roll and (d) a locking assembly comprising a first flap and a second flap configured to couple together to resist separation in a first direction and to allow separation in a second direction opposite to the first direction, wherein when coupled together the first flap and the second flap are configured to support weight of the first sterile adapter, and when allowed to separate the first and second flaps are configured to release the first sterile adapter from the frame assembly.
Ueda, in the same field of endeavor of a drape used to cover a surgical instrument ([0003]) attached to a robotic arm ([0020]), teaches a drape with an unused state (Figure 3, [0034]) and in-use state (Figure 4, [0035]). The drape is attached to the instrument aperture at the distal end of the instrument arm ([0034]) where the unused state is characterized by folded segments of drape unfolded via proximal draw members based on the length of the deployed or deploying instrument arm ([0034]). The intermediate folds shown in the cross section of Figure 4 cause an inversion of the drape between the two ends of the drape.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the drape over the robotic arm in Choi by incorporating the folding mechanism to transition from a stored to deployed state in Ueda. This would have been obvious because both Choi and Ueda discuss a drape applied to an instrument arm and Ueda provides a solution/improvement to store excess drape when the drape is not fully deployed on the instrument arm. Therefore, a person of ordinary skill in the art would be motivated to improve the assembly of Choi by incorporating the folding mechanism to transition from a stored to deployed state in Ueda.
Arco, in the same field of endeavor of a surgical drape (Col 4, Lines 59-68 and Col 5, Lines 1-10), teaches that either a fan fold or roll fold could be used by a drape in a storage configuration (Col 7, Lines 28-37). This reference establishes excess drape can be stored in a smaller space via rolling the drape.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drape over the robotic arm in Choi by rolling the drape when the drape is undeployed in Arco. Given a number of options which Arco suggests would be considered by a person skilled in the art, including fan folds or roll folds, it would have been obvious to roll the drape as storage for undeployed segments of the drape in Choi. A person of ordinary skill in the art would have a reasonable expectation of successfully rolling the drape in Choi (Choi [0085-0086] – the drape can take on a number of conformational changes around the instrument arm).
Karguth, in the same field of endeavor of a sterile drape covering a robotic arm ([0002]), teaches a sterile cover that shields coupling elements in a sterile lock positioned between a manipulator arm and instrument unit ([0017], [0102]). Karguth teaches two flaps 208 and 210 attached via hinges are used to cover the sterile lock where the flaps can only be placed in either a closed position to protect sterile components (Fig. 12, [0120]) or open position (Fig. 11, [0120]) to allow connections between interface elements ([0116]). Connecting flaps are held in place in a closed configuration via guiding beads and tines and keep the engagement means of the coupling unit covered ([0120]). The flaps are only released in a one-way direction when the locking mechanism engages with sterile unit 400 and resist forces or weights applied in the other direction ([0131]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Choi’s drape for a robotic arm assembly with a hole for the instrument connection by incorporating the flap cover for an adapter between a manipulator arm and instrument in Karguth. This would have been obvious because both Choi and Karguth discuss draping a robotic arm with an instrument attachment interface and Karguth provides a solution/improvement to protect sterile interface components with a sterile cover when flaps are in the closed configuration. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Choi by incorporating the flap cover for an adapter between a manipulator arm and instrument in Karguth.
Regarding Claim 2, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi does not disclose wherein the first roll is configured to resist unrolling.
As stated in claim 1, the proposed combination with Arco yields either a fan fold or roll fold could be used by a drape in a storage configuration (Col 7, Lines 28-37). This reference establishes excess drape can be stored in a smaller space via rolling the drape. The drape can be stored in a rolled shape, which would be interpreted as resisting unrolling.
Regarding Claim 3, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi does not disclose wherein the first roll is oriented toward the first and second ends. Note the instant specification describes the first and second rolls in [00081] and a third roll in [00082]. These passages and accompanying figures lead to an interpretation of these rolls as successive layers as the drape is rolled up (e.g. the first roll is presented as the innermost layer and the third layer is presented as the outermost layer). The orientation of the rolls towards a first and second end (seen in the instant specification at [000106]) is interpreted as rolls folds with folds oriented in the same longitudinal axis as the sleeve.
As stated in claim 1, the proposed combination with Ueda yields a drape sleeve with an unused state (Figure 3, [0034]) and in-use state (Figure 4, [0035]). The drape is attached to the instrument aperture at the distal end of the instrument arm ([0034]) where the unused state is characterized by folded segments of drape unfolded via proximal draw members based on the length of the deployed or deploying instrument arm ([0034]). The folds shown in the cross section of Figure 4 cause an inversion of the drape with ends of the folds orientated toward the two ends of the sleeve.
As stated in claim 1, the proposed combination with Arco yields either a fan fold or roll fold could be used by a drape in a storage configuration (Col 7, Lines 28-37 – any number of roll folds can be used). This reference establishes excess drape can be stored in a smaller space via rolling the drape. The roll folds would have the same orientation as the fan folds presented in Figures 3 and 4 along the longitudinal axis.
Regarding Claim 4, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi does not disclose wherein the intermediate portion further comprises a second roll, wherein the first and second rolls are in contact with each other. Note the instant specification describes the first and second rolls in [00081] and a third roll in [00082]. These passages and accompanying figures lead to an interpretation of these rolls as successive layers as the drape is rolled up (e.g. the first roll is presented as the innermost layer and the third layer is presented as the outermost layer).
As stated in claim 1, the proposed combination with Ueda yields a drape sleeve with an unused state (Figure 3, [0034]) and in-use state (Figure 4, [0035]). The drape is attached to the instrument aperture at the distal end of the instrument arm ([0034]) where the unused state is characterized by folded segments of drape unfolded via proximal draw members based on the length of the deployed or deploying instrument arm ([0034]). The folds shown in the cross section of Figure 4 cause an inversion of the drape with ends of the folds orientated toward the two ends of the sleeve.
As stated in claim 1, the proposed combination with Arco yields either a fan fold or roll fold could be used by a drape in a storage configuration (Col 7, Lines 28-37). This reference establishes excess drape can be stored in a smaller space via rolling the drape. Successive roll folds would be in contact with each other.
Regarding Claim 5, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi further discloses wherein the first sleeve includes a tubular cover (Fig. 8, [0080] – the sleeve is a tubular cover placed around the robotic arm).
Regarding Claim 6, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi further discloses wherein the first sterile adapter includes a first adapter portion configured to couple with a first side of an instrument hub of the first movable robotic arm after deployment of the sterile drape over the first movable robotic arm (Figs. 1 and 6-7 – an adapter connecting the arm with an instrument can be seen; page 5 (translation): “The present invention provides a surgical robot and a sterile drape capable of fixing a sterile drape to a surgical robot at an accurate position, making it easy to mount a sterile adapter or clamp even when the sterile drape is covered, and covering a plurality of robot arms at once”).
Regarding Claim 9, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi further discloses wherein the first end is substantially enclosed ([0058] – the first end is mostly enclosed save for a hole where the sterile adapter passes through the drape).
Regarding Claim 12, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi discloses a drape which is coupled to a first sterile adapter (Page 7 (translation): “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter, and a sterile drape can have an opening hole perforated corresponding to a position where the sterile adapter is mounted. In this case, an adhesive portion may be formed on the outer periphery of the open hole to allow a sterile adapter to be attached”). However, Choi does not disclose wherein the first sterile adapter is configured to be removably housed adjacent to the first and second flaps.
Karguth, in the same field of endeavor of a sterile drape covering a robotic arm ([0002]), teaches a sterile cover that shields coupling elements in a removable sterile lock positioned between a manipulator arm and instrument unit ([0017], [0102]). Karguth teaches two flaps 208 and 210 attached via hinges are used to cover the sterile lock where the flaps can only be placed in either a closed position to protect sterile components (Fig. 12, [0120]) or open position (Fig. 11, [0120]) to allow connections between interface elements, such as a sterile adapter ([0116]). Connecting flaps are held in place in a closed configuration via guiding beads and tines ([0120]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Choi’s drape for a robotic arm assembly with a hole for the instrument connection by incorporating the flap cover for a connection with a sterile adapter in Karguth. This would have been obvious because both Choi and Karguth discuss draping a robotic arm with an instrument attachment interface and Karguth provides a solution/improvement to protect sterile interface components with a sterile cover when flaps are in the closed configuration. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Choi by incorporating the flap cover for a connection with a sterile adapter in Karguth.
Regarding Claim 13, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi further discloses comprising:
• (a) a second sterile adapter configured to be received by a second movable robotic arm of the robotic surgical system (Fig.8 – Multiple robotic arms; Translation Page 5 – “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter”); and
• (b) a second sleeve configured to extend over the second movable robotic arm (Fig. 5, [0080] – each arm can be draped via a sleeve), the second sleeve comprising:
(i) a first end coupled with the second sterile adapter (Page 7 (translation): “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter, and a sterile drape can have an opening hole perforated corresponding to a position where the sterile adapter is mounted. In this case, an adhesive portion may be formed on the outer periphery of the open hole to allow a sterile adapter to be attached”).
Choi does not disclose (ii) a second end disposed opposite the first end of the second sleeve, wherein the first end of the second sleeve is inverted toward the second end of the second sleeve, and (iii) an intermediate portion disposed between the first and second ends of the second sleeve, wherein the intermediate portion of the second sleeve includes a first roll.
As stated in claim 1, the proposed combination with Ueda yields a drape with an unused state (Figure 3, [0034]) and in-use state (Figure 4, [0035]). The drape is attached to the instrument aperture at the distal end of the instrument arm ([0034] – “The drape 3 includes a cylindrical aperture cover 31 that is attached to the distal end of the tubular portion 61 of the microscope unit”) where the unused state is characterized by folded segments of drape unfolded via proximal draw members based on the length of the deployed or deploying instrument arm ([0034]). The folds shown in the cross section of Figure 4 cause an inversion of the drape between the two ends of the drape
As stated in claim 1, the proposed combination with Arco yields either a fan fold or roll fold could be used by a drape in a storage configuration (Col 7, Lines 28-37). This reference establishes excess drape can be stored in a smaller space via rolling the drape.
Regarding Claim 15, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi does not disclose wherein the first sleeve defines a first central axis that extends longitudinally between the first and second ends of the first sleeve, wherein the first roll of the first sleeve is oriented away from the first central axis and toward the first and second ends of the first sleeve. Note the instant specification describes the first and second rolls in [00081] and a third roll in [00082]. These passages and accompanying figures lead to an interpretation of these rolls as successive layers as the drape is rolled up (e.g. the first roll is presented as the innermost layer and the third layer is presented as the outermost layer). The orientation of the rolls towards a first and second end (see instant specification at [000106]) is interpreted as roll folds with folds oriented in the same longitudinal axis as the sleeve. An orientation away from the central axis (see instant specification [00081]) is interpreted as rolls toward the sides of the sleeve away from the central axis of the sleeve.
As stated in claim 1, the proposed combination with Ueda yields a drape sleeve with an unused state (Figure 3, [0034]) and in-use state (Figure 4, [0035]). The drape is attached to the instrument aperture at the distal end of the instrument arm ([0034]) where the unused state is characterized by folded segments of drape unfolded via proximal draw members based on the length of the deployed or deploying instrument arm ([0034]). The folds shown in the cross section of Figure 4 cause an inversion of the drape with the folds occurring away from the central axis of the sleeve.
As stated in claim 1, the proposed combination with Arco yields either a fan fold or roll fold could be used by a drape in a storage configuration (Col 7, Lines 28-37). This reference establishes excess drape can be stored in a smaller space via rolling the drape. Successive roll folds would be in contact with each other.
Regarding Claim 16, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi further discloses comprising the first movable robotic arm, wherein the first sterile adapter is coupled with an end of the first movable robotic arm (Translation Page 5 – “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter”), wherein the first sleeve extends along a length of the first movable robotic arm (Fig. 5, [0080] – each arm can be draped via a sleeve).
Regarding Claim 17, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi further discloses further comprising:
• (a) the first movable robotic arm (Fig. 5, [0080] – plurality of robotic arms);
• (b) a second movable robotic arm (Fig. 5, [0080] – plurality of robotic arms); and
• (c) an adjustable arm support, wherein the first and second movable robotic arms are coupled with the adjustable arm support (Fig. 5, [0080] – arms combined in main body);
Regarding Claim 18, the assembly according to Claim 17 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi further discloses the sterile drape further including an arm support cover coupled with the first sleeve and configured to extend over the adjustable arm support (Fig. 5, [0080] – “it may be simpler to drape the entire robot at once with one drape, and for this purpose, the sterilization drape (20) according to the present embodiment is composed of a body part (32) that covers the main body part (3) of the robot, and a plurality of arm parts (34) that cover each of the plurality of robot arms (5), as illustrated in FIG. 5”).
Claims 7-8 and 19 are rejected under U.S.C 103 as being unpatentable over Choi (KR 20110057108 A1) in view of Ueda (US 2018/0280101 A1), Arco (US 4,627,427), Karguth (US 2016/0151115 A1), and Anderson (US 7699855 B2). Note a machine translation via Espacenet (https://worldwide.espacenet.com) is used to interpret the disclosure in Choi - see attached for copy of translation.
Regarding Claim 7, the assembly according to Claim 6 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi discloses an adapter connecting the surgical arm with an instrument (Figs. 1 and 6-7) and a sterile drape placed over the surgical arm and adapter (page 5 (translation): “The present invention provides a surgical robot and a sterile drape capable of fixing a sterile drape to a surgical robot at an accurate position, making it easy to mount a sterile adapter or clamp even when the sterile drape is covered, and covering a plurality of robot arms at once”). Choi does not disclose wherein the first sterile adapter includes a second adapter portion configured to couple with a second side of the instrument hub of the first movable robotic arm after deployment of the sterile drape over the first movable robotic arm.
Anderson, in the same field of endeavor of a robotic arm with a drape (Fig. 9A, Col 1, Lines 49-64), teaches sterile wrist unit, cannula, and scope adapter portions can be detachably connected across a sterile drape to a forearm assembly 46, which is further attached to the robotic arm (Fig. 3A, Col 7, Lines 65-67 and Col 8, Lines 1-29). Any number of adapter portions (such as wrist unit, cannula, and scope adapters) can be attached to the manipulator assemblies 4 (Col 11, Lines 1-20).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Choi’s robotic arm assembly by incorporating the adapter portions for attaching multiple end-effectors in Anderson. This would have been obvious because both Choi and Anderson discuss a robotic arm with an instrument attachment interface for end-effectors and Anderson provides a solution/improvement to the instrument hub to allow multiple types of end-effectors to be used simultaneously during a procedure. Therefore, a person of ordinary skill in the art would be motivated to improve the assembly of Choi by incorporating the adapter portions for attaching multiple end-effectors in Anderson.
Regarding Claim 8, the assembly according to Claim 7 is obvious over Choi in view Ueda, Arco, Karguth, and Anderson, as indicated hereinabove. Choi discloses an adapter connecting the surgical arm with an instrument (Figs. 1 and 6-7) and a sterile drape placed over the surgical arm and adapter (page 5 (translation): “The present invention provides a surgical robot and a sterile drape capable of fixing a sterile drape to a surgical robot at an accurate position, making it easy to mount a sterile adapter or clamp even when the sterile drape is covered, and covering a plurality of robot arms at once”). Choi does not disclose wherein the first and second adapter portions are configured to couple together prior to deployment of the sterile drape over the first movable robotic arm.
As stated in claim 7, the proposed combination with Anderson yields sterile wrist unit, cannula, and scope adapter portions which can be detachably connected across a sterile drape to a forearm assembly 46, which is further attached to the robotic arm (Fig. 3A, Col 7, Lines 65-67 and Col 8, Lines 1-29). Any number of adapter portions (such as wrist unit, cannula, and scope adapters) can be attached to the manipulator assemblies 4 (Col 11, Lines 1-20). The adapter portions can be attached through the drape, but can also be attached to the forearm adapter regardless of whether a drape needs to be traversed.
Regarding Claim 19, Choi discloses a sterile drape assembly ([0001]) comprising:
• (a) a first sterile adapter portion configured to couple to a first side of a movable robotic arm of a robotic surgical system (Page 5 (translation): “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter”);
• (c) a sterile drape comprising a sleeve configured to extend over the movable robotic arm (Fig. 5, [0080] – each arm can be draped via a sleeve), the sleeve comprising:
(i) a first portion terminating at a first end (Page 7 (translation): “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter, and a sterile drape can have an opening hole perforated corresponding to a position where the sterile adapter is mounted. In this case, an adhesive portion may be formed on the outer periphery of the open hole to allow a sterile adapter to be attached”), and
(ii) a second portion terminating at a second end opposite the first end (Fig. 5, [0080] – arms combined in main body at the proximal end of the arms opposite the instrument adapter).
Choi does not disclose:
• (b) a second adapter portion configured to couple to a second side of the movable robotic arm, the first adapter portion and the second adapter portion being releasably coupled to each other prior to deployment from a frame assembly in a packaged configuration and de-coupled from each other in a deployed configuration;
• (i) the first portion of the sleeve connected to the first adapter portion and the second adapter portion, and
• wherein, in a packaged configuration, the first portion of the sleeve is inverted toward the second portion of the sleeve, and an intermediate portion of the sleeve between the first and second ends is rolled.
Ueda, in the same field of endeavor of a drape used to cover a surgical instrument ([0003]) attached to a robotic arm ([0020]), teaches a drape with an unused state (Figure 3, [0034]) and in-use state (Figure 4, [0035]). The drape is attached to the instrument aperture at the distal end of the instrument arm ([0034] – “The drape 3 includes a cylindrical aperture cover 31 that is attached to the distal end of the tubular portion 61 of the microscope unit”) where the unused state is characterized by folded segments of drape unfolded via proximal draw members based on the length of the deployed or deploying instrument arm ([0034]). The intermediate folds shown in the cross section of Figure 4 cause an inversion of the drape between the two ends of the drape
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the drape over the robotic arm in Choi by incorporating the folding mechanism to transition from a stored to deployed state in Ueda. This would have been obvious because both Choi and Ueda discuss a drape applied to an instrument arm and Ueda provides a solution/improvement to store excess drape when the drape is not fully deployed on the instrument arm. Therefore, a person of ordinary skill in the art would be motivated to improve the assembly of Choi by incorporating the folding mechanism to transition from a stored to deployed state in Ueda.
Arco, in the same field of endeavor a surgical drape (Col 4, Lines 59-68 and Col 5, Lines 1-10), teaches that either a fan fold or roll fold could be used by a drape in a storage configuration (Col 7, Lines 28-37). This reference establishes excess drape can be stored in a smaller space via rolling the drape.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drape over the robotic arm in Choi by rolling the drape when the drape is undeployed in Arco. Given a number of options which Arco suggests would be considered by a person skilled in the art, including fan folds or roll folds, it would have been obvious to roll the drape as storage for undeployed segments of the drape in Choi. A person of ordinary skill in the art would have a reasonable expectation of successfully rolling the drape in Choi (Choi [0085-0086] – the drape can take on a number of conformational changes around the instrument arm).
Anderson, in the same field of endeavor of a robotic arm with a drape (Fig. 9A, Col 1, Lines 49-64), teaches sterile wrist unit, cannula, and scope adapter portions can be detachable connected across a sterile drape to a forearm assembly 46, which is further attached to the robotic arm towards the distal end of the robotic arm (Fig. 3A, Col 7, Lines 65-67 and Col 8, Lines 1-29). Any number of adapter portions (such as wrist unit, cannula, and scope adapters) can be attached to the manipulator assemblies 4 (Col 11, Lines 1-20). Therefore, the adapters can be coupled together via the common forearm adapter or remain separate.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Choi’s robotic arm assembly by incorporating the adapter portions for attaching multiple end-effectors in Anderson. This would have been obvious because both Choi and Anderson discuss a robotic arm with an instrument attachment interface for end-effectors and Anderson provides a solution/improvement to the instrument hub to allow multiple types of end-effectors to be used simultaneously during a procedure. Therefore, a person of ordinary skill in the art would be motivated to improve the assembly of Choi by incorporating the adapter portions for attaching multiple end-effectors in Anderson.
Claim 10 is rejected under U.S.C 103 as being unpatentable over Choi (KR 20110057108 A1) in view of Ueda (US 2018/0280101 A1), Arco (US 4,627,427), Karguth (US 2016/0151115 A1), and Marshall (US 2020/0352669 A1) (cited previously). Note a machine translation via Espacenet (https://worldwide.espacenet.com) is used to interpret the disclosure in Choi - see attached for copy of translation.
Regarding Claim 10, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi discloses a drape can be fitted to the shape of components of the robotic system ([0085]). However, Choi does not disclose wherein the first end includes an elastic member.
Marshall, in the same field of endeavor of a draping a robotic surgical arm ([0006]), teaches a sterile interface portion at the distal end of the drape (Fib. 6b, [0080]) made of an elastic material ([0073] – “Suitably the interface portion of the drape comprises a material with a low modulus (for example an elastic or tensile modulus) or with a low friction coefficient, in at least one direction”). The purpose of the interface potion of the drape is to prevent ruckles from forming when motions from the robotic system are transmitted through the drape ([0084]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Choi’s drape for a robotic arm assembly by incorporating the elastic drape material at the distal end of the robotic arm near the instrument interface in Marshall. This would have been obvious because both Choi and Marshall discuss draping a robotic arm with an instrument attachment interface and Marshall provides a solution/improvement to prevent ruckles from forming in the drape and maintain a sterile interface between the instrument and adapter. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Choi by incorporating the elastic drape material at the distal end of the robotic arm near the instrument interface in Marshall.
Claim 14 is rejected under U.S.C 103 as being unpatentable over Choi (KR 20110057108 A1) in view of Ueda (US 2018/0280101 A1), Arco (US 4,627,427), Karguth (US 2016/0151115 A1), and Marinchak (US 2014/338676 A1). Note a machine translation via Espacenet (https://worldwide.espacenet.com) is used to interpret the disclosure in Choi - see attached for copy of translation.
Regarding Claim 14, the assembly according to Claim 1 is obvious over Choi in view Ueda, Arco, and Karguth as indicated hereinabove. Choi discloses alternatively draping individual elements in the robotic assembly ([0088]), as opposed to using one piece for the whole assembly (Fig. 5, [0080] – “it may be simpler to drape the entire robot at once with one drape, and for this purpose, the sterilization drape (20) according to the present embodiment is composed of a body part (32) that covers the main body part (3) of the robot, and a plurality of arm parts (34) that cover each of the plurality of robot arms (5), as illustrated in FIG. 5”), necessitating a mechanism to connect the drapes ([0089] – “After wrapping the robot with a drape in the shape of a wrapping cloth, the ends need to be joined together to make the drape airtight. To do this, a fastening means such as a vinyl zipper, snap button, Velcro, or magnet can be used at the ends of the drape”). However, Choi does not disclose a mechanism comprising a tear label configured to couple together at least one of the first sleeve or the first sterile adapter with at least one of the second sleeve or the second sterile adapter.
Marinchak, in the same field of endeavor of a draping over medical equipment ([0005]), teaches connections between sections of the drape removable via tear away portions as a choice ([0009] – “The removable portions may be removed in any suitable manner such as a tear away portion. Of course, the removable portion may be attached with fasteners, a clasp, buttons, a zipper or any other suitable mechanism”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the separable robotic assembly drape in Choi to include the tear away perforations as a connection element in Marinchak. Marinchak provides a list of alternative connection types that partially overlaps with the list in Choi, making the tear away connection in Marinchak obvious to try. A person of ordinary skill in the art would have a reasonable expectation of successfully implementing the tear away drape connections in Marinchak.
Claim 20 is rejected under U.S.C 103 as being unpatentable over Choi (KR 20110057108 A1) in view of Karguth (US 2016/0151115 A1) and Anderson (US 7699855 B2). Note a machine translation via Espacenet (https://worldwide.espacenet.com) is used to interpret the disclosure in Choi - see attached for copy of translation.
Regarding Claim 20, Choi discloses an assembly comprising:
• (a) a first sterile adapter configured to be received by a first movable robotic arm of a robotic surgical system (Page 5 (translation): “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter”);
• (b) a first sleeve (Fig. 5, [0080] – each arm can be draped via a sleeve) coupled with the first sterile adapter (Page 7 (translation): “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter, and a sterile drape can have an opening hole perforated corresponding to a position where the sterile adapter is mounted. In this case, an adhesive portion may be formed on the outer periphery of the open hole to allow a sterile adapter to be attached”).
However, Choi does not disclose (a) wherein the first sterile adapter includes a first adapter portion and a second adapter portion releasably coupled to each other prior to the first sterile adapter being received by the first movable robotic arm and (c) first and second flaps that collectively form a trapdoor, wherein the first and second flaps are configured to couple together to resist separation in a first direction and support the first sterile adapter prior to the first sterile adapter being received by the first movable robotic arm, wherein the first and second flaps are further configured to allow separation in a second direction that is opposite to the first direction when the first sterile adapter is being received by the first movable robotic arm, the first and second flaps being positioned adjacent to the first sterile adapter and the first sleeve.
Karguth, in the same field of endeavor of a sterile drape covering a robotic arm ([0002]), teaches a sterile cover that shields coupling elements in a sterile lock positioned between a manipulator arm and instrument unit ([0017], [0102]). Karguth teaches two flaps 208 and 210 attached via hinges are used to cover the sterile lock where the flaps can only be placed in either a closed position to protect sterile components (Fig. 12, [0120]) or open position (Fig. 11, [0120]) to allow connections between interface elements ([0116]). Connecting flaps are held in place in a closed configuration via guiding beads and tines and keep the engagement means of the coupling unit covered ([0120]). The flaps are only released in a one-way direction when the locking mechanism engages with sterile unit 400 ([0131]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Choi’s drape for a robotic arm assembly with a hole for the instrument connection by incorporating the flap cover for an adapter between a manipulator arm and instrument in Karguth. This would have been obvious because both Choi and Karguth discuss draping a robotic arm with an instrument attachment interface and Karguth provides a solution/improvement to protect sterile interface components with a sterile cover when flaps are in the closed configuration. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Choi by incorporating the flap cover for an adapter between a manipulator arm and instrument in Karguth.
Anderson, in the same field of endeavor of a robotic arm with a drape (Fig. 9A, Col 1, Lines 49-64), teaches sterile wrist unit, cannula, and scope adapter portions can be detachably connected across a sterile drape to a forearm assembly 46, which is further attached to the robotic arm (Fig. 3A, Col 7, Lines 65-67 and Col 8, Lines 1-29). Any number of adapter portions (such as wrist unit, cannula, and scope adapters) can also be attached to the manipulator assemblies 4 (Col 11, Lines 1-20). The adapter portions can be attached through the drape, but can be attached to the forearm adapter regardless of whether a drape needs to be traversed.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Choi’s robotic arm assembly by incorporating the adapter portions for attaching multiple end-effectors in Anderson. This would have been obvious because both Choi and Anderson discuss a robotic arm with an instrument attachment interface for end-effectors and Anderson provides a solution/improvement to the instrument hub to allow multiple types of end-effectors to be used simultaneously during a procedure. Therefore, a person of ordinary skill in the art would be motivated to improve the assembly of Choi by incorporating the adapter portions for attaching multiple end-effectors in Anderson.
Claim 21 is rejected under U.S.C 103 as being unpatentable over Choi (KR 20110057108 A1) in view of Karguth (US 2016/0151115 A1), Anderson (US 7699855 B2), and Marinchak (US 2014/338676 A1). Note a machine translation via Espacenet (https://worldwide.espacenet.com) is used to interpret the disclosure in Choi - see attached for copy of translation.
Regarding Claim 21, the assembly according to Claim 20 is obvious over Choi in view Karguth and Anderson, as indicated hereinabove. Choi discloses (a) a second sterile adapter configured to be received by a second movable robotic arm of the robotic surgical system (Fig.8 – Multiple robotic arms; Translation Page 5 – “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter”); (b) a second sleeve coupled with the second sterile adapter (Page 7 (translation): “The surgical robot includes a robot arm having an instrument holder, the instrument holder is equipped with a sterile adapter, and a sterile drape can have an opening hole perforated corresponding to a position where the sterile adapter is mounted. In this case, an adhesive portion may be formed on the outer periphery of the open hole to allow a sterile adapter to be attached”), the second sleeve adjacent to the first sleeve (Fig. 5, [0080] – each arm can be draped via a sleeve).
Choi discloses alternatively draping individual elements in the robotic assembly ([0088]), as opposed to using one piece for the whole assembly (Fig. 5, [0080]), necessitating a mechanism to connect the drapes near the proximal end of the sleeves ([0089] – “After wrapping the robot with a drape in the shape of a wrapping cloth, the ends need to be joined together to make the drape airtight. To do this, a fastening means such as a vinyl zipper, snap button, Velcro, or magnet can be used at the ends of the drape”) opposite the sterile adapter hole where the trapdoor from Karguth would be integrated in the proposed combination stated in claim 20.
However, Choi does not disclose (c) a tear label releasably coupling the first and second sleeves, wherein the trapdoor is at a first end of the assembly and the tear label is at a second end of the assembly opposite of the first end.
Marinchak, in the same field of endeavor of a draping over medical equipment ([0005]), teaches connections between sections of the drape removable via tear away portions ([0009] – “The removable portions may be removed in any suitable manner such as a tear away portion. Of course, the removable portion may be attached with fasteners, a clasp, buttons, a zipper or any other suitable mechanism”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the separable robotic assembly drape in Choi to include the tear away perforations as a connection element in Marinchak. Marinchak provides a list of alternative connection types that partially overlaps with the list in Choi, making the tear away connection in Marinchak obvious to try. A person of ordinary skill in the art would have a reasonable expectation of successfully implementing the tear away drape connections in Marinchak.
Conclusions
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796 (for SPE Jennifer McDonald)
Prosecution Insights