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 1-9 and 24-30 are pending, claims 10-23 have been cancelled, claims 24-30 have been added, and claims 1-9 and 24-30 are currently under consideration for patentability under 37 CFR 1.104. Previous drawing objections and 35 USC 112 Rejections have been withdrawn in light of Applicant’s arguments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 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.
Claim Objections
Claims 2-9 are objected to because of the following informalities: change “according to claim X” to “according to claim X,” (i.e., add a comma). Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a resecting device” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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:
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.
Claim(s) 1-2, 5, 7-9, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hendrick (US 2022/0241029), in view of Avigal (US 2019/0374242) and Moll (US 2008/0058836).
Regarding claim 1, Hendrick discloses a medical robot system (figure 1) for use in intrauterine procedures (surgery…pelvis…[0009]), comprising: a robotic arm (12a and 14, figure 1) having a plurality of moveable arm segments (see 12a and 14, figure 1); an endoscope (20, figure 1 | see outer sheath 26 with an inner sheath 28 and sheath insert 30, figure 5) detachably coupled to a distal segment (14, figure 1) of the robotic arm, the endoscope having an elongate endoscope shaft (see shaft of 20, figure 2) with a working channel therein (see 32 and 34, figure 5 | also see ports 42, 44, and 46, figure 5), the elongate endoscope shaft extending about a longitudinal axis to a distal end (see axis of 20, figure 1); a resecting device (this element is interpreted under 35 USC 112f as a tubular cutter | 60a, figure 3a; surgical tool…electrosurgery tip, a cutting tip…[0053]; the cutting tip is on the distal end of a tube) detachably coupled to the distal segment, the resecting device having an elongate resecting shaft (see 72 or 74, figure 4) configured for introduction through the working channel of the elongate endoscope shaft (see 42 or 44, figure 5). Hendrick is silent regarding the elongate endoscope shaft extending to a distal end carrying an image sensor; a retractor having an elongate retractor shaft configured for introduction through the working channel of the elongate endoscope shaft, where a working end of the elongate retractor shaft comprises a concave surface that permits positioning of the elongate retractor shaft over a tubular shape of the elongate resecting shaft to permit the elongate retractor shaft and the elongate resecting shaft to be slidably and rotationally disposed in the working channel and where the elongate retractor shaft is also configured to be rotated within the working channel relative to the tubular shape of the elongate resecting shaft.
Avigal teaches a system (300, figure 9a) with an outer tube (160, figures 9) with a hollow grasping head (162, figures 9). The hollow grasping head has opposing pivotally connected grasping jaws (164 and 166, figures 9). A tissue grasping manipulator (168, figures 9) disposed within a control mechanism (118, figures 9) is provided for controlling the grasping head (162, figures 9) closing and/or opening ([0120]). The first and second grasping jaws is at least partially filled with viscoelastic material and/or malleable material ([0023]).
Moll teaches an image capture device that can be a fiberscope or a CCD chip ([0164]).
It would have been obvious to modify the guide tube (72, figure 14) of Hendrick with the hollow grasping head (162, figures 9), malleable material ([0023]), and tissue grasping manipulator (168, figures 9) as taught by Avigal. Doing so would provide the ability to affect tissue while also serving as a conduit for other instruments to be inserted through or removed from ([0119]). Further, it would have been obvious to one of ordinary skill in the art before the time of filing to modify the endoscope shaft to carry an image sensor as taught by Moll (CCD chip [0164]). Doing so would be an alternative to a fiberscope for image capture ([0164]). The modified system would have the elongate endoscope shaft extending to a distal end carrying an image sensor (CCD chip [0164]; Moll in 24/25, figure 3a of Hendrick); a retractor (see 162, figures 9; Avigal | 72, figure 14; Hendrick) having an elongate retractor shaft (see shaft of 72, figure 14; Hendrick) configured for introduction through the working channel of the elongate endoscope shaft (see figure 5 and 14; Hendrick), where a working end of the elongate retractor shaft comprises a concave surface (see tubular shape of 72, figure 14; Hendrick | see 162, figures 9; Avigal) that permits positioning of the elongate retractor shaft over a tubular shape of the elongate resecting shaft (see 72 is over 74, figure 14; Hendrick | see 162, figures 9; Avigal) to permit the elongate retractor shaft and the elongate resecting shaft to be slidably and rotationally disposed in the working channel (see arrows in figure 14; Hendrick | see 162, figures 9; Avigal) and where the elongate retractor shaft is also configured to be rotated within the working channel relative to the tubular shape of the elongate resecting shaft (see circular arrows for 72, figure 14; Hendrick).
Regarding claim 2, Hendrick further discloses a controller (200, figure 1; Hendrick) configured to operate at least one of the endoscope, resecting device and retractor (to control one or more device located on the surgical robot apparatus 10 [0048]).
Regarding claim 5, Hendrick further discloses the controller is adapted to (interpreted as functional language) actuate (input console 200…input to control one or more devices [0048]) a motor driven cutting member of the resecting device (electrosurgery tool or cutting device [0046] | interpreted the cutting device can be motor driven in order to be actuated with the controller; see components on 22 that couple to 60, figure 3a).
Regarding claim 7, Hendrick further discloses the controller is adapted to (interpreted as functional language) actuate (input console 200…input to control one or more devices [0048]) a negative pressure source in communication with the retractor (suction [0049]; suction may occur when a retractor is in use).
Regarding claim 8, Hendrick and Avigal further disclose the controller is adapted to (interpreted as functional language) actuate (input console 200…input to control one or more devices [0048]) a motor drive to move a jaw structure of the retractor between open and closed positions (electrosurgery tip…tissue manipulator [0053]; interpreted the tissue manipulator to be motor driven in order to be actuated with the controller; see components on 22 that couple to 60, figure 3a; Hendrick | tissue grasping manipulator 168, figures 9; Avigal).
Regarding claim 9, Hendrick further discloses the controller is adapted to (interpreted as functional language) actuate (input console 200…input to control one or more devices [0048]) a negative pressure source that communicates with an interior channel and suction ports in the retractor (port…suction…during a surgical operation [0049]; suction may occur when the retractor is in use).
Regarding claim 30, Hendrick further discloses a sleeve (18 and 40, figure 8) having a distal tapered seal member (see taper of 18 and 40, figure 8 | insert bushing 41 forms a seal…[0059]), wherein the robotic arm further includes a seal drive component (broadly interpreted the seal drive component as a structure that moves the seal member relative to the tubes 70-74, figure 4 | guide tube 72…translated…by independent drive components inside tool cartridge 60 [0054]) configured to adjust the distal tapered seal member to maintain contact with a cervix during the intrauterine procedures (surgery…pelvis…[0009]).
Claim(s) 3-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hendrick A (US 2022/0241029) and Avigal (US 2019/0374242) and Moll (US 2008/0058836) as applied to claim 2 above, and further in view of Hendrick B (US 2022/0296225)
Regarding claim 3, Hendrick A, Avigal, and Moll disclose all of the features in the current invention as shown above in claim 2. They are silent regarding a motor drive configured to move the elongate endoscope shaft at least one of axially and rotationally relative to its longitudinal axis.
Hendrick B teaches a system (10, figure 1) with a holding arm (12, figure 1). A holding arm interface (30, figures 1 and 3) connects the actuation unit (20, figures 1-3) to the holding arm (12, figure 1). The system may have one or more motors to provide gravity or dynamic compensation ([0061]). The actuation unit provides control of one or more instruments and has a camera (22, figure 2) disposed on it ([0062]). The actuation unit has a drape plate (224, figure 12) with integrated coupling (228, figure 12), where the plate provides motor motion to the manipulators embedded in sterile instrument cartridges (410, figure 12 | [0100]).
It would have been obvious to modify the system of Hendrick A and Avigal and Moll to have the actuation unit (20, figures 1-3) and holding arm interface (30, figures 1 and 3) as taught by Hendrick B. Doing so would provide an actuation unit having integrated motor control and safety controller hardware on board ([0112]). The modified system would have a motor drive (drive motors…[0100]; Hendrick B) configured to move the elongate endoscope shaft at least one of axially and rotationally relative to its longitudinal axis (angular orientation via rotating…[0087]; Hendrick B | translated axially or rotated about its longitudinal axis [0053]; Hendrick A).
Regarding claim 4, Hendrick A, Avigal, and Moll disclose all of the features in the current invention as shown above in claim 2. They are silent regarding a motor drive configured to move the elongate resecting shaft at least one of axially and rotationally relative to its longitudinal axis.
Hendrick B teaches a system (10, figure 1) with a holding arm (12, figure 1). A holding arm interface (30, figures 1 and 3) connects the actuation unit (20, figures 1-3) to the holding arm (12, figure 1). The system may have one or more motors to provide gravity or dynamic compensation ([0061]). The actuation unit provides control of one or more instruments and has a camera (22, figure 2) disposed on it ([0062]). The actuation unit has a drape plate (224, figure 12) with integrated coupling (228, figure 12), where the plate provides motor motion to the manipulators embedded in sterile instrument cartridges (410, figure 12 | [0100]).
It would have been obvious to modify the system of Hendrick A and Avigal (US 2019/0374242) and Moll to have the actuation unit (20, figures 1-3) and holding arm interface (30, figures 1 and 3) as taught by Hendrick B. Doing so would provide an actuation unit having integrated motor control and safety controller hardware on board ([0112]). The modified system would have a motor drive (drive motors…[0100]; Hendrick B) configured to move the elongate resecting shaft at least one of axially and rotationally relative to its longitudinal axis (angular orientation via rotating…[0087]; Hendrick B | translated axially or rotated about its longitudinal axis [0053]; Hendrick A).
Regarding claim 6, Hendrick A, Avigal, and Moll disclose all of the features in the current invention as shown above in claim 2. They are silent regarding a motor drive configured to move the elongate retractor shaft at least one of axially and rotationally relative to its longitudinal axis.
Hendrick B teaches a system (10, figure 1) with a holding arm (12, figure 1). A holding arm interface (30, figures 1 and 3) connects the actuation unit (20, figures 1-3) to the holding arm (12, figure 1). The system may have one or more motors to provide gravity or dynamic compensation ([0061]). The actuation unit provides control of one or more instruments and has a camera (22, figure 2) disposed on it ([0062]). The actuation unit has a drape plate (224, figure 12) with integrated coupling (228, figure 12), where the plate provides motor motion to the manipulators embedded in sterile instrument cartridges (410, figure 12 | [0100]).
It would have been obvious to modify the system of Hendrick A and Avigal (US 2019/0374242) and Moll to have the actuation unit (20, figures 1-3) and holding arm interface (30, figures 1 and 3) as taught by Hendrick B. Doing so would provide an actuation unit having integrated motor control and safety controller hardware on board ([0112]). The modified system would have a motor drive (drive motors…[0100]; Hendrick B) configured to move the elongate retractor shaft at least one of axially and rotationally relative to its longitudinal axis (angular orientation via rotating…[0087]; Hendrick B | translated axially or rotated about its longitudinal axis [0053]; Hendrick A).
Claim(s) 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Hendrick (US 2022/0241029) and Avigal (US 2019/0374242) and Moll (US 2008/0058836) as applied to claim 1 above, and further in view of To (US 2011/0098531).
Regarding claim 24, Avigal further teaches the working end of the elongate retractor shaft comprises a resilient material (viscoelastic material and/or malleable material [0023]; Avigal). Hendrick, Avigal, and Moll are silent regarding the resilient material forming a living hinge.
To teaches a retractor cannula device (100, figure 1) with an atraumatic retractor assembly (116, figures 3). The retractor assembly has two jaws (308 and 310, figures 3). The jaws mate to form a substantially smooth round shape and a working space formed in between ([0074]). The jaws are coupled to a shaft (102, figures 3) using a hinge mechanism (306, figures 3), where the hinges may be living hinges and/or mechanical hinges ([0074]). The entire retractor assembly may be configured to be slidable along the shaft ([0074]).
It would have been obvious to modify the working end of the elongate retractor shaft with living hinges ([0074]) as taught by To to open and close the jaws ([0074]). Doing so would be an alternative to mechanical hinges ([0074]). The modified system would have the resilient material forming a living hinge (living hinges [0074]; To).
Regarding claim 25, Hendrick further discloses the resilient material forms a curvilinear repose shape (see 72, figure 14; Hendrick) when extended outwardly from the working channel and is capable of a tensioned axial straight shape when retracted into the working channel (see axial arrow for 72, figure 14).
Regarding claim 26, Hendrick further discloses the curvilinear repose shape is in a form of an "S" curve or a "C" curve (see 72, figure 14 | guide tube steers…[0053] | 72 can form an “S” or “C” curve).
Regarding claim 27, Hendrick further discloses an axially moveable deflecting member (see 74, figure 14; Hendrick) configured for movement in the working channel (see axial and circular arrows for 74, figure 14) to adjust the curvilinear repose shape (inner tube 74 using independent drive components [0054] | 74 can move 72, figure 14).
Regarding claim 28, Avigal further teaches the working end of the elongate retractor shaft has a jaw structure (162, figures 9; Avigal) configured to move between an open position and a closed position (see figures 9).
Regarding claim 29, Avigal further teaches the jaw structure is adapted for closing by an actuator member (see arrow in image below) that is configured to be axially moveable (see figures 9; Avigal).
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Note to Applicant(s)
The Examiner suggests amending the independent claim with language to further narrow in on the shape of the retractor.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
May 30, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Prosecution Insights