DETAILED ACTION
All references to the instant specification have been cited using PG Pub US20260026900A1.
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 1-8 are currently pending and under consideration.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Jan. 21, 2025 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Drawings
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “28” has been used to designate both “working channel” and “black handle element”. 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. 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 do not include the following reference sign(s) mentioned in the description: holding arm (34) in ¶[0100]. 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. 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(s) not mentioned in the description: 14, 22, 36, and 38 in Fig. 4. 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.
Specification
The use of the term “Avicenna Roboflex” in ¶[0004] and ¶[0038], “Intuitive” and “Ion” in ¶[0005], “Monarch” ¶[0006], “Hansen Medical” “Magellan” and “Sensei” in ¶[0007], and “Corindus” and “CorPath GRX” in ¶[0008], which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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:
Claims 1 and 6: “patient-side unit” enabling defined positioning of the patient access; and
Claim 2: “output unit” for the system status.
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. For “patient-side unit”, the specification discloses the location in the immediate vicinity of the patient’s urethra to define positioning of the patient’s access, the device described in Fig. 9 with a clamp, and any equivalents thereof. For “output unit”, the specification discloses a display, several RGB LEDs, and any 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.
Claims 1-8 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 limitation "the handle unit" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the handle unit” will be interpreted as “a handle unit”.
Claim 1 recites the limitation "the patient" in line 5. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the patient” will be interpreted as “a patient”.
Claim 1 recites the limitation "the patient access" in line 6. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the patient access” will be interpreted as “a patient access”.
Claim 2 recites the limitation "the system status" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the system status” will be interpreted as “a system status”.
Claim 3 recites the limitation "the surgeon" in line 2-3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the surgeon” will be interpreted as “a surgeon”.
Claim 5 recites the limitation "the control" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the control” will be interpreted as “a control”.
Claim 5 recites the limitation "the movement mode" in line 4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the movement mode” will be interpreted as “a movement mode”.
Claim 6 recites the limitation "the control" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the control” will be interpreted as “a control”.
Claim 6 recites the limitation "the end effector" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the end effector” will be interpreted as “an end effector”.
Claim 6 recites the limitation "the joint angles" in line 4-5. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the joint angles” will be interpreted as “joint angles”.
Claim 6 recites the limitation "the time" in line 5. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the time” will be interpreted as “a time”.
Claim 8 recites the limitation "the control" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the control” will be interpreted as “a control”.
Claims 4 and 7 depend from claims 3 and 1, respectively, and are therefore rejected for the same reasons as above.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 6, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Awano et al. (US 20200121403 A1, published Apr. 23, 2020, hereinafter referred to as “Awano”).
Regarding claim 1, Awano teaches a surgical system for minimally invasive robotic surgery (Fig.’s 1A-2B “the robotic arm 100 of the surgery supporting apparatus” ¶[0037]) comprising: a holding arm (Fig.’s 1A-2B and 10-12 “linear-motion robot arm 120” ¶[0041]) which has a holder for the handle unit of a conventional endoscope (Fig.’s 1A-2B and 10-12 “The linear-motion robot arm 120 includes an endoscope holder capable of attaching a general endoscope to the gimbal mechanism” ¶[0041]), a patient-side unit (Fig.’s 1A-2B and 10-12 “A part of a robot medical instrument 127 is inserted into the body cavity through a robot-side sheath tube 125” ¶[0045]) that can be attached close to the patient and enables defined positioning of the patient access (Fig.’s 1A-2B and 10-12 “robot-side sheath tube 125 inserted into a small-diameter hole formed in the abdominal wall 150.” ¶[0045] therefore it is attached close to the patient and is guided into the patient access).
Regarding claim 2, Awano teaches the surgical system further comprising an output unit for the system status (Fig. 2A “the control unit 201 changes the manipulation mode of the surgery supporting apparatus 200, changes an arm to be controlled, and changes information to be displayed on a display unit 203” ¶[0050]).
Regarding claim 3, Awano teaches wherein the holding arm can be manually positioned by the surgeon and locked in a desired position (Fig. 2A-3 “the position detection control unit 510 includes a braking mechanism, and brakes the motion of the support block 502 (that is, the linear motion of the horizontal robot arm 110) so as to maintain the posture” ¶[0060], “the horizontal robot arm 110 according to this embodiment includes a brake release switch 311 for facilitating a manual manipulation of the robot arm.” ¶[0067], “the brake for maintaining the posture of the robot arm is released only while the brake release switch 311 is pressed.” ¶[0069] and ¶[0115] Fig. 17 element S1706).
Regarding claim 6, Awano teaches wherein the control of the holding arm is designed such that the position of the patient-side unit can be determined by touching it with the end effector of the holding arm, due to the position of the end effector being known via the position of the joint angles of the holding arm at the time of touching (“Each robot arm of this embodiment has a passive joint. As described above with reference to FIGS. 9 and 12, therefore, when a surgical instrument is inserted into a sheath tube attached to the abdominal region of a patient and the insertion point 901 is determined, the control unit 201, for example, can calculate and specify the position of the distal end of the robot medical instrument 127 in the body cavity.” ¶[0108] and Fig. 17 “In step S1707, the control unit 201 detects from the robot-side insertion depth measurement unit 126 that the robot medical instrument 127 is inserted into the robot-side sheath tube 125 into which nothing is inserted. In step S1708, the control unit 201 associates the manually manipulated robot arm with the robot-side sheath tube 125 whose insertion has been detected.” ¶[0116]).
Regarding claim 8, Awano teaches wherein the control of the holding arm is designed to generate a virtual barrier beyond which the handle unit cannot be moved, so that injury to the patient and/or excessive kinking of the endoscope is prevented (“the surgery supporting apparatus 200 is used to assist the operative procedure of an operator by using a robot arm. For example, the use of the surgery supporting apparatus 200 makes it possible to secure an operation field by holding an organ and fixing it in the place by the robot medical instrument 127” ¶[0127], “the robot medical instrument 127 is spatially kept fixed, the retraction force sometimes weakens when dissection progresses and the shape of the organ changes. A surgery by an operator can be performed more smoothly if the retraction force on an organ can simply be adjusted in accordance with the progress and status of the surgery, in the same manner as when a human performs retraction as an assistant.” ¶[0128], and “the control unit 201 controls the robot arm such that the distal end coordinates of the robot medical instrument 127 move in only a predetermined direction matching the retraction direction (that is, restricts the movement of the distal end position of the medical instrument 127)” ¶[0131] therefore, the handle cannot move beyond the set boundaries).
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwab (US 20200015916 A1, published Apr. 23, 2020, hereinafter referred to as “Schwab”).
Regarding claim 1, Schwab teaches a surgical system for minimally invasive robotic surgery (“FIG. 1 is a diagrammatic illustration of an example teleoperated surgical system 100” ¶[0029] and “A manipulator slave device 104 is also included in the teleoperated system 100.” ¶[0031]) comprising: a holding arm (Fig. 1 “Manipulator slave device 104 can include one or more arm assemblies 120. In some examples, one of the arm assemblies 120 can be configured to hold an image capturing device, e.g., an endoscope 122” ¶[0031]) which has a holder for the handle unit of a conventional endoscope (Fig. 1 “one of the arm assemblies 120 can be configured to hold an image capturing device, e.g., an endoscope 122” ¶[0031]), a patient-side unit (Fig. 1 “During a surgical procedure, the slave device 104 can be positioned close to a patient (or simulated patient) for surgery, where it can remain stationary until a particular surgical procedure or stage of a procedure is completed.” ¶[0031]) that can be attached close to the patient and enables defined positioning of the patient access (Fig. 1 ¶[0032] therefore it is attached close to the patient and is guided into the patient access).
Regarding claim 5, Schwab teaches the surgical system further comprising at least one sensor for detecting whether the handle unit is held by an operator, wherein, if this is the case, the control of the holding arm is changed to the movement mode (“The method senses movement of the handle caused by the periodic forces with one or more sensors configured to sense motion of the handle in the one or more degrees of freedom, and detects a change in the movement of the handle using the one or more sensors, where the change is greater than a threshold amount. In response to detecting the change in the motion of the handle, the method activates a controlling mode in which the handle is moveable by the user in the one or more degrees of freedom to moveably control the device.” ¶[0013]).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Awano in view of Barakat (US 20220192707 A1, published June 23, 2022, hereinafter referred to as “Barakat”).
Regarding claim 4, Awano teaches the surgical system of claim 3.
Awano does not disclose wherein the holding arm automatically maintains its position as soon as no more external forces are exerted on it.
Barakat’s invention relates to robotic anatomical manipulation systems and methods, and more specifically, to robotic uterine manipulation systems and methods for use in minimally invasive hysterectomies (¶[0004]). The software can place the arm in Freedrive Mode, where the user can manually move each joint of the arm to a desired position. In Freedrive Mode (UR5 Software), the software can maintain the new position of the arm once the user manually moves it (¶[0082]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to create a system wherein the holding arm automatically maintains its position after a force is exerted on it as taught by Barakat in the system of Awano in order to move the joints of the arm into the desired position.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Awano in view of Gombert et al. (WO 2014127967 A1, published Aug. 28, 2014, hereinafter referred to as “Gombert”).
Regarding claim 7, Awano teaches the surgical system of claim 1.
Although Awano teaches that the endoscope can be attached to the endoscope holder and various types and shapes can be attached matching the shape as needed in ¶[0084], Awano does not disclose wherein the handle unit can be separated from the holding arm without tools.
Gombert’s invention relates to a device for holding a surgical instrument and a sheath (pg. 1, ln. 14). The holding device according to the invention is preferably designed as a structural unit which can be mounted on a robot and in particular a robot head via fastening means. The fastening means can be designed, for example, as a screw connection, a locking connection, a clamping connection or as any other known device for the detachable connection of two parts, such as a quick-action clamping connection with movable pins. The fastening means can preferably be operated without tools (pg. 3, ln. 12-16).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to design the surgical device of Awano with a handle unit that can be separated from the holding arm without tools as taught by Gombert because these methods of attachment are well known and are quick-action for quick swapping of tools.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Anderson et al. (US 20130198625 A1) – sensors detect when grip is being touched;
Miller et al. (US 20210290328 A1) – grip registering;
Kim et al. (US 20220265373 A1) – automatically moving and then holding position; and
Hansen (US 20220388156 A1) – maintaining robot positioning.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5:30 and every other F 8-4:30ET.
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, 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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/E.N.C./ Patent Examiner, Art Unit 3792
/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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