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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature canceled from the claims. No new matter should be entered.
In re claim 1, “carriage position sensor”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character not mentioned in the description:
Reference character: 3003 (FIG. 30).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 objected to because of the following informalities. Appropriate correction is required.
In re claim 1, the limitation “wherein the carriage position sensor communicates the position of the carriage across a sterile barrier”, should read “wherein the carriage position sensor is configured to communicate the position of the carriage across a sterile barrier”.
Specification
The disclosure is objected to because of the following informalities. Appropriate correction is required.
In paragraph [0040] of Applicants specification the reference character “104” is used to indicate both the sterile disposable piece and the sensor PCB (“…between the sterile disposable piece 104 and the modular robotic arm 101 and sensor PCB 104 The sensor PCB 104 may interact with the sterile disposable piece 104…”). Examiner believes the reference character used to indicate the sensor PCB should be “102” not “104”. In other words, the excerpt from paragraph [0040] should read “…between the sterile disposable piece 104 and the modular robotic arm 101 and sensor PCB 102. The sensor PCB 102 may interact with the sterile disposable piece 104…”.
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 10 and 11 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.
In re claim 10, the limitation “further comprising a sterile drape”, promotes a clarity concern. Specifically, it is unclear how “a sterile drape” differs from the “sterile barrier” defined in claim 1. As discussed in Applicant’s specification [0007] “a sterile drape” is a “sterile barrier”. For examination purposes, the limitation “further comprising a sterile drape” will be interpreted as “wherein the sterile barrier further comprises a sterile drape”.
In re claim 11, the limitation “wherein the carriage position sensor determines the position of the carriage by rotating a magnetic field”, promotes a clarity concern. Specifically, the limitation “determines the position of the carriage by rotating a magnetic field” differs from Applicant’s description of how the carriage position sensor “determines the position of the carriage” provided in the specification. As best understood, the carriage position sensor does not determine the position of the carriage by rotating a magnetic field. Instead, the carriage position sensor determines the position of the carriage by measuring an orientation of the magnetic field [0075]. For examination purposes, the limitation “wherein the carriage position sensor determines the position of the carriage by rotating a magnetic field” will be interpreted as requiring the carriage position sensor to determine the position of the carriage by detecting changes in the orientation of the magnetic field.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-7 and 10 are rejected under 35 U.S.C. 102(a)(1)/103 as being unpatentable over Orban III et al. (US 8,998,799) [in view of Cau (US 11,497,571)].
In re claim 1, Orban III discloses a sterile disposable interface (abstract; FIGS. 3A-3B) for percutaneous instruments (24; col. 9, lines 29-38), the sterile disposable interface comprising:
an insertion rail (120);
a carriage (122),
wherein the carriage is attached to the insertion rail (FIG. 5; col. 8, lines 35-37); and
a carriage position sensor (col. 11, lines 16-20: Examiner notes the position sensor is being interpreted as the portion that detects if the carriage is in “a proximal position”, for instance the encoder discussed in col. 10, lines 26-28),
wherein the carriage position sensor determines a position of the carriage relative to a position of the insertion rail as the carriage moves along the insertion rail (col. 11, lines 6-10; col. 11 lines 16-20);
wherein the carriage position sensor communicates the position of the carriage across a sterile barrier (70; col. 11, lines 7-20; Examiner notes that carriage position is communicated to control mechanism (see FIG. 1: 6)).
It is apparent that the position sensor of Orban III tracks the position of the carriage as it moves along the insertion rail given that Orban III both includes an encoder and is capable of detecting if the carriage is at a proximal position. However, in so far that this is not explicitly stated, claim 1 is alternatively rejected under 35 U.S.C. 103 as follows:
Cau discloses an analogous sterile disposable interface (FIG. 10) that comprises a carriage (structure encompassed by 25, shown in greater detail in FIGS. 3-4) that slides along an insertion rail (FIG. 2: 5). As discussed in Cau, the carriage includes an encoder (12) that measures a position of the carriage as it moves along the insertion rail (col. 7, lines 14-17).
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 carriage position sensor of Orban III to determine a position of the carriage as the carriage moves along the insertion rail, as taught by Cau. One would have been motivated to make this modification because doing so would allow a system to accurately track the position of any surgical instrument that may be attached to the carriage.
In re claim 2, Orban III discloses, further comprising an instrument adapter (64).
In re claim 3, Orban III discloses, further comprising an instrument guide (FIG. 4: 66; col. 11, lines 7-14).
In re claim 5, Orban III discloses, wherein the sterile disposable interface laterally disengages from the percutaneous instrument at the carriage (FIG. 3B shows opening (80) on carriage which receives an instrument)
In re claim 6, Orban III discloses, further comprising a top lock (col. 11, lines 29-31; Examiner notes the break acts as a top lock as it keeps the carriage located at a proximal position during instrument installation).
In re claim 7, Orban III discloses, further comprising a carriage break (col. 11, lines 29-31).
In re claim 10, Orban III discloses, further comprising a sterile drape (70; col. 7, lines 45-47).
Claim Rejections - 35 USC § 103
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Orban III et al. (US 8,998,799), in view of Ruiz Morales (US 2009/0024142).
In re claim 4, Orban III does not disclose, further comprising a homing switch.
Ruiz Morales discloses a robotic surgical system that like Orban III is used for performing minimally invasive surgical procedures (abstract). The robotic surgical system determines an absolute position of a slider carriage (FIG. 19: 430) through an automated homing procedure [0130]. As discussed in Ruiz Morales, the automated homing procedure is performed using a series of limit switches (426, 428).
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 sterile disposable interface of Orban III to include a homing switch, as taught by Ruiz Morales. One would have been motivated to make this modification because homing is a known way to determine an absolute coordinate of a component in a robotic surgical system (Ruiz Morales, [0130]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Orban III et al. (US 8,998,799), in view of Mishra et al. (US 2024/0173089).
In re claim 8, Orban III does not disclose, further comprising a *rotation lock.
Mishra discloses an analogous surgical instrument adapter (404) that attaches to a surgical guide (500). Mishra further discloses the surgical instrument adapter including a clamp (404a) that is configured to rotationally or axially lock the surgical guide in a position [0057].
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 sterile disposable interface of Orban III to further comprise a rotation lock, as taught by Mishra. One would have been motivated to make this modification to prevent the surgical guide from moving during the surgical operation (Mishra, [0047]).
*As best understood, a rotation lock is being interpreted as a structure that provides resistance to rotation (instant specification, [0046]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Orban III et al. (US 8,998,799), in view of Balter et al. (US 2022/0383555).
In re claim 9, Orban III does not disclose, further comprising an adjustment button.
Balter discloses a robotic surgical assembly (FIG. 1, FIG. 2) that like Orban III includes a sliding rail (46a) which is configured to move a carriage (52; [0053]: “instrument drive unit”) along a longitudinal axis. The robotic surgical assembly also includes a series of buttons (FIG. 1: 53) that an operator can use to manually adjust a position of the carriage [0054].
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 sterile disposable interface of Orban III to further comprise an adjustment button, as taught by Balter. One would have been motivated to make this modification to provide the operator with a way to manually adjust the position of the carriage (Balter, [0054]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Orban III et al. (US 8,998,799), in view of Shelton IV et al. (US 2020/0405408).
In re claim 11, Orban III does not disclose, wherein the carriage position sensor determines the position of the carriage by rotating a magnetic field (Regarding the limitation “determines the position of the carriage by rotating a magnetic field”, see above section Claim Rejections 112).
Shelton IV discloses a robotic surgical assembly (FIGS. 23-25 and 27) that like Orban III includes a carriage (FIG. 24: 40042) slidably mounted on a rail (40040), a sterile drape (40061), and a carriage position sensor [0350]. As discussed in Shelton IV, the carriage position sensor can be any type of sensor capable of generating position data [0352] including an encoder [0352] or a magnetic rotatory positioning system [0364].
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 carriage position sensor of Orban III to be a magnetic positioning sensor, as taught by Shelton IV. One would have been motivated to make this modification because the encoder and magnetic positioning sensor are known functional equivalents. Moreover, one of ordinary skill in the art would have the ability to select the type of sensor that would best meet their needs. Accordingly, such a modification would yield “wherein the carriage position sensor determines the position of the carriage by rotating a magnetic field”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cooper et al. (US 2009/0248039) discloses a sterile interface for a robotic surgical instrument (abstract, FIG. 1).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796