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 .
Response to Amendment
This Action is in response to the Amendment filed March 26, 2026.
In view of the Amendment, the objection to claim 10 and the rejection of claims 1-18 under 35 USC 112 (a), and the rejections specific to claims 5, 7 and 16 under 35 USC 112(b) for the reasons set forth in the 010/09/2026 Office Action, are withdrawn. However, the rejection of claim s 1-18 under 35 USC 112 (b) is maintained as set forth below.
Claims 5-7, 10, 13, and 16 are amended.
Claims 1-18 are pending.
Response to Arguments
Applicant's arguments filed March 26, 2026 have been fully considered but they are not persuasive.
35 USC 112(b)
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., claim language does not require the angled path to be created in isolation as the mechanical interface/transmission element at the opening creates a path that traverses from the sterile region to the non-sterile region (or vice versa) through the opening as described in the specification which includes unspecified structure not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Fig. 2 shows a sterile barrier/cover 10 in light grey. However, Fig. 2 does not show where the angled path is located. Is it between the transmission element/mechanical interface 5 and the unspecified/unnumbered structure in the figure, or between the sterile barrier/cover 10 and the unspecified structure 13 in the figure. How does the sterile barrier with an opening create an angled path and where is the angled path, if it does not do it by itself. The Examiner notes that the originally-filed substitute specification paragraph [0032], the angled path is described as a gap between a sterile cover member, which covers the transmission element in the region of the opening, and the transmission element is advantageous. Paragraphs [0041] and [0042] of the originally-filed specification (OFS) describe that the gap in the remaining opening between the sterile barrier and the transmission element can be reduced by one of constructive minimization of the gap width to the smallest possible dimension, longest possible gap length to create a high aspect ratio, and twisting the gap path where there is no direct straight line connection from the sterile outer area to the first non-sterile inner surface … by changing the direction of the gap several times up to a meandering design, the protective effort of the gap guide can be maximized and the risk of contamination can be reduced towards zero. In addition paragraph [0047] of the OFS recites: To achieve sterile conditions, part of the insertion device 13 and the mechanical connection interface 5 can be covered by a closure cap 6. Paragraph [0050] of the OFS recites: some part of the insertion device 13 can be enclosed in a sterile cover (drape) … To ensure a sterile barrier, the sterile cap 6 is screwed on in this area. The closure cap 6 thereby clamps the sterile cover 10 and in this way prevents intraoperative slippage. That is, the sterile barrier in conjunction with the closure cap 6 and the insertion device 13 achieves sterile conditions.
Since Fig. 2 appears to show that the seal (additional/optional structure) is in contact with the mechanical interface/transmission element, the Office Action dated 01/09/2026 asked if that structure was considered part of the surrounding elements. Applicant’s response was the specification provides context for the meaning of “surrounding elements”. However, the context is missing in the claims. The Examiner notes that paragraph [0050] of the corresponding PG-Pub recites: The transmission element can be guided through the opening without contact to surrounding elements, but does not mention what the surrounding elements are. The context described in paragraph [0050] is not recited in the claims (i.e., so that frictional forces between the sterile barrier and the transmission element cannot be superimposed and falsify the measurement). However, Fig. 2 illustrates an unspecified structure that is between the sterile cover and the transmission element/mechanical interface 5. Is the transmission element in contact with this structure as it appears in Fig. 2 to be in contact with the seal, which appears to be in contact with the transmission element/mechanical interface. The Examiner notes that the description of the OFS appears to restate the claim language of “without contact to surrounding elements”. The Examiner has found 5 paragraphs of the OFS ([0029], [0033], [0037] (PG-Pub [0050]), [0038], and [0053] ), but only one paragraph mentions without contact to the surrounding elements. It is unclear what the surrounding elements are in the claims.
With respect to claim 4, in order to positively recite the element, the claim should be amended to recited wherein the sterile barrier includes a sterile cover member, and the angled path is in a gap between the sterile cover member … . The Examiner notes that “a non-sterile sensor” is inferentially included in line 2 of claim 1, and then is used again in line 8. The non-sterile sensor should be recited as an element of the measuring device as well.
While Applicant corrected a typo in line 3 and the revised the second step/clause in line 6, Claim 13 is directed to an assembly sequence which has three clauses. No change was made to the third clause which does not explain how the first and second clause “already ensures at this stage that contact of the non-sterile surfaces by the user is no longer possible”. The Examiner believes that this language is narrative in form and that it is unclear what is intended by this clause. In other words, how does this claim relate to an assembly sequence?
35 USC 102
In response to Applicant’s argument that Kostrzewski does not anticipate the measuring device of claim 1, because claim 1 recites “the sterile barrier creates an angled path through the opening in the sterile barrier”. As best understood, the sterile barrier of Kostrzewski is capable of creating an angled path when the sterile cap pinches the sterile drape/barrier between the cap and the robot connector 1106. Kostrzewski expressly discloses:
the surgical drape will typically be in place over the robot arm and cart when the end effector 108 is inserted into, or otherwise attached to, the connector 1106. The connector 106 may be configured to at least partially protrude from the surgical drape, such that a sterile cap, collar, or other covering of the connector may be installed prior to the attachment of the end effector 1108 into the connector 1106 to maintain sterile seal. (paragraph [0122])
That is, Kostrzewski discloses the claimed structure of a sterile barrier and a transmission element where the sterile barrier is capable of creating an angled path through the opening via the sterile cap, collar, or other covering. See State Contracting & Eng’g Corp. v. Condotte America, Inc., 68 USPQ2d 1481 (Fed. Cir. 2003). A reference may be directed to an entirely different problem than the one addressed by the inventor, or may be from an entirely different field of endeavor than that of the claimed invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation recited in the claims. In this case, the patented structure of Kostrzewski discloses every structural limitation and is capable of creating an angled path through the opening. The angled path would have at least one bend where the cap cinches the opening of sterile barrier of Kostrzewski to maintain a sterile seal.
With respect to the recitation of “the transmission element is guided through the opening without contact to surrounding elements”, the structure of Kostrzewski and its disclosure is capable of protruding through its opening without contact to the sterile barrier and the transmission element as there is an opening within the sterile barrier and it makes sense to not have the transmission element in contact with the sterile barrier at the opening in order to prevent contamination.
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.
Claims 1-18 are 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 1 recites: the sterile barrier creates an angled path through the opening in the sterile barrier into the sterile area. It is unclear how the sterile barrier creates an angled path in its opening. Fig. 2 illustrates a sterile cover (barrier) with an opening where the sterile cover is between an unnumbered element with threads and a cap 6 with corresponding recesses to receive the threads at its opening. Thus, the sterile barrier doesn't create an angled path by itself.
In addition, claim 1 recites: the transmission element is guided through the opening without contact to surrounding elements. Since the additional labyrinth seal 11 can be a surrounding element in claims 1-18 and it appears to be contacting the transmission element, this scope of this clause is not understood.
In claim 4, "a sterile cover member" is inferentially included and it is unclear if the applicant is positively reciting or functionally reciting the element. If the element is being functionally recited, it is suggested to use functional terms such as "adapted to be" or "for". If the element is being positively recited, it is suggested to first state the system includes the element before it is used in a connection in the claim. In addition, claim 4 recites that a sterile cover member covers the transmission element, which implies that the sterile cover member is placed on top of or contacts the transmission element.
Claim 6 recites the limitation "sterile encapsulation of the measuring device" in line 2. There is insufficient antecedent basis for this limitation in the claim as a sterile barrier or sterile region is recited in claim 1. The sterile barrier is one part of the measuring device how does it encapsulate itself?
Claim 13 is directed to a sequence of components of a measuring device which starts with a first bullet point or clause (lines 3-6), but the following bullet points are in narrative form (lines 7-12) and do not indicate how they relate to a sequence (i.e., the claims are indefinite as a result of the narrative form). Presumably, the transmission element is passed through the opening after the sterile barrier is attached to the measuring device in a second step. The third bullet point is more of a statement than a step as noted in the 01/09/2026 Office Action.
Claims 2-3, 5, 7-12, 14-15, and 17-18 are rejected because they depend from an indefinite claim.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8, 11, and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2016/0081754 to Kostrzewski et al. (hereinafter referred to as "Kostrzewski").
Regarding claim 1, Kostrzewski discloses a measuring device for a surgical or other medical environment for measuring a mechanical physical quantity using a non- sterile sensor (e.g., Figs. 4 and 6A-B and paragraphs [0114]-[0115]: the force sensor may be attached to a flange on robot 406 and measures the forces and torques applied to the tool [in the sterile area]), comprising: a sterile barrier separating a non-sterile region from a sterile region (e.g., paragraph [0115]: sterile cover 608b may be wrapped around the robot arm 604a/604b and between the force sensor 602b and the tool holder 606b to ensure sterilization and Fig. 6B), wherein the non-sterile sensor is located in the non-sterile area of the measuring device (e.g., Fig. 6B: force sensor 602b); a transmission element for mechanically transmitting the mechanical physical quantity gathered in the sterile area to the non-sterile sensor (e.g., paragraphs [0022], [0114]: a user 402 applies forces on a tool and force measurements are transmitted to a force control box 408); and [0123]: where the robot arm connector 1106 attaches a force sensor to its side as shown in Fig. 6B, the arm connector is configured to pass electrical signals between robot arm 1114 (non-sterile region) and end effector 1108 (sterile region)), whereby the transmission element projects from the non-sterile sensor through an opening in the sterile barrier into the sterile area (e.g., paragraphs [0122]-[0123]: robot arm connector 1106 partially protrudes from [an opening in] the surgical drape/barrier and a sterile cap covers the connector 1106 to maintain a sterile seal), wherein in the sterile barrier is capable of creating an angled path through the opening in the sterile barrier (i.e., when the sterile cap pinches the sterile drape/barrier between the cap and the robot connector 1106), wherein the transmission element is guided through the opening without contact to surrounding elements (it is the Office Action's position that that the transmission element 604b does not come in contact with surrounding elements on its sides as shown in Fig. 6B).
With respect to claims 2 and 17, Kostrzewski discloses the measuring device according to claim 1 and to claim 13, respectively, wherein the sterile barrier comprises a flexible element/sterile drape (e.g., paragraph [0042]: Fig. 6A-C are diagrams illustrating locations for mounting a force sensor and sterile drape), which envelops and shields at least the non-sterile parts of the measuring device from the sterile environment.
As to claim 3, Kostrzewski discloses the measuring device according to claim 1, wherein the sterile barrier is configured to minimize the risk of contamination of the sterile region (e.g., paragraph [0121]: the sterile drape may cover all of the surgical robot body thereby protecting the patient from exposure to non-sterile surfaces, dust, or other material originating from the robotic system and protecting the equipment from surgical waste and fluids).
With respect to claim 4, Kostrzewski discloses the measuring device according to claim 1, wherein the angled path is in a gap between a sterile cover member, which covers the transmission element in the region of the opening, and the transmission element (e.g., paragraph [0122]: robot arm connector 1106 or robot arm connector 604b of 6B protrudes from sterile drape and a sterile cap, collar, or other covering of the connector may be installed to maintain a sterile seal; when the sterile cap pinches the sterile drape/barrier between the cap and the robot arm connector 1106 or robot arm connector 604b of 6B, an angled path in the form of a gap would be created).
As to claim 5, Kostrzewski discloses the measuring device according to claim 1, wherein the sterile barrier is configured to minimize a risk of contamination through the opening by inhibiting passage of:
With respect to claim 6, Kostrzewski discloses the measuring device according to claim 1, wherein sterile encapsulation of the measuring device by the sterile barrier comprises a rigid, single or multi-part housing, a sterile drape, or a foil, which includes an opening to allow direct connection to the sensing location of the mechanical physical quantity (e.g., paragraphs [0114]-[0115] and [0122]: sterile drape includes an opening to allow direct connection to the force sensor 602b from the sensing location in the sterile area).
As to claim 7, Kostrzewski discloses the measuring device according to claim 1, in the form of a medical handling system (e.g., Fig. 15, robot 1502) with a handling device (e.g., Fig. 6B, robot arm 604b) for handling a medical device attached to the handling device within or relative to a body region of a patient (e.g., paragraphs [0114]- [0115] and Fig. 6B: user 402 applies forces and torques on a tool (medical device unnumbered in Fig. 6B) attached to a force/torque sensor 404 (602b in Fig. 6B)), wherein the handling device has, as the non-sterile sensor, at least one force sensor for detecting a force transmitted from the medical device to the handling device in at least one measuring direction (e.g., paragraphs [0115]-[0116]: force sensor 602 may be located on the robot and is connected to an intermediary analog box that provides for direct measurement of forces applied by the user on the tool), the medical handling system having an evaluation unit for evaluating a force signal which is emitted by the force sensor and represents the force detected by the force sensor (e.g., paragraphs [0114]: force control box 408 converts the analog data into digitized data and transmits them to the controller 412; and [0110]).
With respect to claim 8, Kostrzewski discloses the measuring device according to claim 7, wherein the evaluation unit is configured to determine a compensated force signal which is corrected for gravity and/or acceleration influences acting on the force sensor at least in the at least one measurement direction, which influence the force signal (e.g., paragraph [0133]: movement of an end-effector due to force and/or torque applied by the surgeon is compensated in real time such that the end effector remains in the same, stable position).
As to claim 11, Kostrzewski discloses the measuring device according to claim 7, wherein the handling device is an insertion device for inserting the medical device attached to the insertion device into a body region of a patient (e.g., paragraphs [0027] and [0132]: surgical system 1500 allows the mobile card to be close to the operation table, such that the robot arm is within reach of the patient's body to be operating on, the operator/surgeon manipulates and positions the tool and Figs. 15-16).
With respect to claim 13, Kostrzewski discloses the assembly sequence of the components of a measuring device according to claim 1, wherein: first the sterile barrier is attached to the measuring device, to produce a sterile outer surface and a space inside the sterile barrier which encloses non-sterile surfaces as well as inner surfaces of the sterile barrier (e.g., paragraph [0115]: sterile cover 608b may be wrapped around the robot arm 604a/604b and between the force sensor 602b and the tool holder 606b to ensure sterilization and Figs. 6B and 10), the transmission element is passed through the opening in the sterile barrier, whereby the (non-sterile) inner surfaces within the sterile barrier that are still accessible through the opening are now in turn covered in a sterile manner area (e.g., paragraphs [0122]-[0123]: robot arm connector 1106 partially protrudes from [an opening in] the surgical drape/barrier and a sterile cap covers the connector 1106 to maintain a sterile seal), the geometric design of the transmission element, opening and sterile barrier already ensures at this stage that contact of non-sterile inner surfaces by the user is no longer possible (seems like a statement rather than a limitation).
As to claim 14, Kostrzewski discloses the assembly sequence according to claim 13, wherein the non-sterile surfaces include outer surfaces of the measuring device (e.g., Figs. 6B and 10).
With respect to claim 15, Kostrzewski discloses the assembly sequence according to claim 13, wherein inner surfaces of the sterile barrier include the non- sterile sensor (e.g., Fig. 6B).
As to claim 16, Kostrzewski discloses the measuring device according to claim 1, wherein the sterile barrier is capable of forming an angled path that forms a labyrinth (i.e., when the sterile cap pinches the sterile drape/barrier between the cap and the robot connector 1106).
With respect to claim 18, Kostrzewski discloses the measuring device according to claim 3, wherein the region of the opening is configured to minimize the risk of contamination of the sterile region (e.g., paragraphs [0122]-[0123]: robot arm connector 1106 partially protrudes from [an opening in] the surgical drape/barrier and a sterile cap covers the connector 1106 to maintain a sterile seal).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski as applied to claim 8 above, and further in view of US 2023/0165649 to Fitzsimons et al. (EFD 04/29/2021 and hereinafter referred to as "Fitzsimons"). Kostrzewski discloses the measuring device according to claim 8, but does not expressly disclose that the handling device has at least one gravity sensor with which the gravity influences acting on the force sensor at least in the measuring direction can be determined in the form of a gravity signal, the evaluation unit being configured to determine the compensated force signal taking into account the gravity signal of the gravity sensor. However, Fitzsimons, in a related art: surgical platform for autonomous task execution, teaches that accounting for gravity increases the accuracy of a robot end effector and that the system may compensate for gravity by subtracting the effect of gravity on the sensed tool forces (e.g., paragraphs [0058] and [0071] of Fitzsimons). Accordingly, one of ordinary skill in the art would have recognized the benefits of at least one gravity sensor and modifying an evaluation unit of a robot arm to account for gravitational forces in view of the teachings of Fitzsimons. Consequently, one of ordinary skill in the art would have modified the measuring device of Kostrzewski to include at least one gravity sensor and so that the evaluation unit takes into account the effect of gravity on the sensed tool forces in view of the teachings of Fitzsimons that such were well-known engineering expedients in the surgical robotic art, and because the combination would have yielded a predictable result.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski as applied to claim 8 above, and further in view of US 2016/0030119 to Devengenzo et al. (hereinafter referred to as "Devengenzo"). Kostrzewski discloses the measuring device according to claim 8, but does not expressly disclose that the handling device has at least one acceleration sensor with which the acceleration influences acting on the force sensor at least in the measuring direction can be determined in the form of an acceleration signal, the evaluation unit being set up to determine the compensated force signal taking into account the acceleration signal of the acceleration sensor. However, Devengenzo, in a related art: damping in telesurgical systems, teaches that an acceleration sensor on one linkage can measure a locally experienced vibration arising due to the acceleration of another linkage and the sensed data can be used to damp the vibration or compensate for it (e.g., paragraphs [0074]-[0075] of Devengenzo). Accordingly, one of ordinary skill in the art would have recognized the benefits of an acceleration sensor and to modifying the evaluation unit in a measuring device of forces in order to compensate for the measured acceleration in order to prevent the robotic system from vibrations in view of the teachings of Devengenzo and because the combination would have yielded a predictable result.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski as applied to claim 11 above, and further in view of US 2023/0301733 to Weber et al. (EFD 07/30/2021 and hereinafter referred to as "Weber"). Kostrzewski discloses the measuring device according to claim 11, but does not expressly disclose that the insertion device has, as the transmission element, a mechanical connection interface for attaching the medical device in the form of an electrode array of a cochlear implant to the insertion device. However, Weber, in a related art: system and method for surgical implantation of cochlear implant, teaches robotic cochlear implantation was known to those skilled in the cochlear implant art (e.g., paragraphs [0003] and [0012] of Weber) and that an insertion tool for a cochlear implant was known in the art (e.g., paragraphs [0024] and [0041]-[0042] and inset of Fig. 3 of Weber). Accordingly, one of ordinary skill in the art would have recognized the benefits of using a robotic cochlear implant insertion device in view of the teachings of Weber. Consequently, one of ordinary skill in the art would have been motivated to use the insertion device with an electrode array of a cochlear implant instead of the unnumbered tool within the holder of Fig. 6B of Kostrzewski where the tool holder is outside the sterile barrier/cap combination of Kostrzewski in view of the teachings of Weber that such a robotic system was known to those skilled in the art for implanting a cochlear implant, and because the combination would have yielded a predictable result.
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 CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
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