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
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/26/2025.
Applicant’s election without traverse of Group I, claims 1-9, in the reply filed on 11/26/2025 is acknowledged.
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 disassembly feature in claim 5.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites “advancing the first and second blades along the new axle until a first side of the first and second new blades engages” in lines 5-6 and “mounting a washer on the axle and engaging a second side of the first and second blades with the washer; and securing the washer to the new axle” in lines 8-10 in which the ‘old’ blades appear to be assembled as the new blade set. It is unclear if applicant intended to claim the first and second blades, and the axle or the first and second new blades, and the new axle. For the purposes of examination, the limitations have been interpreted to read “advancing the first and second new blades” and “mounting a washer on the new axle and engaging a second side of the first and second new blades with the washer”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4 and 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hibner et al. (US 2024/0398467 A1) in view of Murrell et al. (US 2019/0105099 A1).
Regarding claim 1, Hibner discloses a method of replacing blades (jaws 210, 212; Fig. 2) of an end effector (end effector 204) of a surgical tool (method of replacing a consumable of a surgical tool; abstract), comprising: moving the end effector (204) distally from an assembled state (Fig. 5A), where the end effector (204) is rotatably mounted to a clevis (distal clevis 602) of a wrist (wrist 206; Figs. 6A-6B) of the surgical tool, to an extended state (as the shaft 202 is translated proximally relative to the end effector 204; Fig. 5B), where an axle (first and/or second pin 706; Fig. 7B) of the end effector is dislodged from open-ended slots (open-ended slots 620) defined in opposing first and second arms (first and second arms 618) of the clevis (Figs. 6A-6B), the end effector including: opposing first and second blades (210, 212); and first and second blade holders (first and second pulleys 606a, 606b), the first blade (210) being mounted to the first blade holder (606a via first jaw pin; [0071]), and the second blade (212) being mounted to the second blade holder (606b via second jaw pin 706; Figs. 7A-7B; [0071]); separating the first and second blade holders (606a, 606b) from the first and second blades (210, 212) in opposing lateral directions (Figs. 6B, 7A); removing the first and second blades (210, 212) from remaining portions of the end effector (Figs. 7B, 9); assembling a new blade set comprising first and second new blades (as one or more “consumable” of the end effector 204 may be replaced include one or both of the upper and lower jaws 210, 212; [0085]); mounting the first and second blade holders to the first and second new blades, respectively (as the steps of disassembly and detachment are reversed with new jaws provided; [0085]); and moving the end effector proximally and back to the assembled state within the open-ended slots (as the steps of disassembly and detachment are reversed with new jaws provided; [0085]).
Hibner fails to disclose wherein the first and second blade holders are rotatably mounted to the axle, separating the first and second blade holders from the first and second blades in opposing lateral directions until the first and second blade holders are removed from the axle, removing the axle from remaining portions of the end effector, assembling a new axle, mounting the first and second blade holders to the new axle, and moving receiving the new axle within the open-ended slots. Instead, two axles (first and second jaw pins 706), which are affixed to the blade holders (606a, 606b), are used to rotate the first and second blades of the end effector (Figs. 7A-7B; [0071]).
However, Murrell teaches an end effector (end effector 1302; Figs. 13-15) rotatably mounted to a clevis (distal clevis 802a) of a wrist (wrist 606; Fig. 8) of a surgical tool (surgical tool 600; Fig. 6; as end effector 1302 of Figs. 13-15 may replace end effector 604 of Figs. 6 and 8-12; [0096]), where an axle (first axle 804a) of the end effector may be dislodged from open-ended slots (first slot 1406a and second slot 1406b) defined in opposing first and second arms (first arm 1004a and second arm 1004b) of the clevis (802a; Figs. 14-15), the end effector (1302) including: opposing first and second blades (jaws 610, 612); and first and second blade holders (first jaw holder 902a and second jaw holder 902b) rotatably mounted to the axle (804a; Figs. 13-15), the first blade (610) being mounted to the first blade holder (902a; Fig. 15), and the second blade (612) being mounted to the second blade holder (902b; Fig. 15).
Hibner teaches one or more “consumables” of the end effector may be replaced and the steps of disassembly and detachment may be reversed to place the surgical tool back in service ([0085]-[0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the end effector of Hibner to include a single replaceable axle that is removable from the blade holders as taught by Murrell rather than two separate axles fixedly attached to blade holders. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of opening and closing first and second blades. The resultant end effector of modified Hibner would cause the first and second blade holders to be rotatably mounted to the axle, such that separating the first and second blade holders from the first and second blades in opposing lateral directions would cause the first and second blade holders to be removed from the axle.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Hibner such that the axle is removed from remaining portions of the end effector and replaced by assembling a new axle, mounting the first and second blade holders to the new axle, and moving receiving the new axle within the open-ended slots in light of the teachings of HIbner in order to replace used parts of the end effector with sterile new parts.
Regarding claim 2, modified Hibner discloses the invention as claimed above, and Hibner further discloses wherein moving the end effector (204) distally from the assembled state (Fig. 5A) to the extended state (Fig. 5B) comprises manually grasping the end effector (via manually tightening the mount 420) and modified Hibner discloses dislodging the axle from the open-ended slots in a distal direction (as the slots 1406a and 1406b of Murrell are open in a distal direction; Fig. 15).
Regarding claim 3, modified Hibner discloses wherein each open-ended slot (1406a, 1406b of Murrell) defines a minimized section (proximal end of slots) that leads into an enlarged section (distal end of slots; Figs. 13, 15 of Murrell), the minimized section providing a smaller gap as compared to the enlarged section (Figs. 13, 15 of Murrell), and wherein moving the end effector distally from the assembled state to the extended state further comprises forcing the axle (804a of Murrell) through the minimized section and out of the open-ended slots (Figs. 13, 15 of Murrell).
Regarding claim 4, modified Hibner discloses wherein the axle (804a of Murrell) provides opposing planar surfaces (flat outer surfaces 1514 of Murrell) at each end and forcing the axle through the minimized section is preceded by aligning the opposing planar surfaces with a longitudinal direction of each open-ended slot (Fig. 15 of Murrell).
Regarding claim 6, modified Hibner discloses the invention as claimed above, and Hibner further discloses wherein a plurality of drive cables (drive cables 608a-608d) extend from a drive housing (drive housing 208) of the surgical tool and terminate at the first and second blade holders (606a, 606b; Figs. 2, 6B), and wherein moving the end effector (204) distally from the assembled state to the extended state comprises paying out slack in the plurality of drive cables from the drive housing as the end effector moves distally (Figs. 6A-6B).
Regarding claim 7, modified Hibner discloses the invention as claimed above, and Hibner further discloses wherein separating the first and second blade holders (606a, 606b) from the first and second blades (210, 212) in opposing lateral directions comprises maintaining the plurality of drive cables attached to the blade holders as the first and second blade holders are removed from the axle (Fig. 7A of Hibner as modified Hibner includes a removable axle).
Regarding claim 8, modified Hibner discloses wherein assembling the new blade set comprises: receiving the new axle (804a of Murrell) within central apertures (openings 1405a, 1405b of Murrell) defined in each of the new blades (610, 612 of Murrell); advancing the first and second blades along the new axle until a first side of the first and second new blades engages an enlarged radial shoulder defined by the new axle (see shoulders of 804a surrounding ends 1408a, 1408b of Murrell; Fig. 15); mounting a washer (circular outer portions surrounding 1102a, 1102b of Murrell; Fig. 15) on the axle and engaging a second side of the first and second blades with the washer (Fig. 15 of Murrell); and securing the washer to the new axle (Figs. 13-15 of Murrell).
Regarding claim 9, modified Hibner discloses the invention as claimed above, and Hibner further discloses wherein moving the end effector (204) distally from the assembled state to the extended state is preceded by decoupling a drive housing (drive housing 208) of the surgical tool from a robotic manipulator (as drive housing 208 is releasably coupled to the robotic surgical system 100; [0038]-[0039]; Fig. 4).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Murrell, fails to disclose wherein each end of the axle provides a disassembly feature (interpreted under 112(f) as opposing flat surfaces of the axle; [0054]) and wherein moving the end effector distally from the assembled state to the extended state is preceded by rotating the axle to a home orientation where the disassembly features are aligned with a longitudinal direction of the open-ended slots. Murrell teaches opposing flat surfaces (1514) on the axle (804a; Fig. 15). However, the flat surfaces are aligned perpendicular to the longitudinal direction of the open-ended slots when in a home orientation (Fig. 15) rather than with a longitudinal direction as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771