The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on June 16, 2026 is acknowledged. Group I was identified as relating to claims 1-9 and 20-23 in the lack of unity correspondence mailed on May 7, 2026. However, with the applicant’s response, the applicant has cancelled claims 4 and 10-37, and added new claims 38-47. Currently, claims 1-3, 5-9 and 38-47 are pending.
Claim Rejections - 35 USC § 112
Second Paragraph
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 2, 3, 5-9, 38-39, 43, 44, 47 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 2 is rejected because “wherein a treatment pose corresponds a spatial alignment…” within line 3 appears to be grammatically incorrect and creates confusion within the claim.
Claim 3 is rejected because “the one or more treatment poses” lacks antecedent basis, since this is introduced in claim 2, while claim 3 depends from claim 1.
Claim 5 is rejected because “the one or more empirically-determined simulation poses” lacks antecedent basis since this is introduced in claim 3, while claim 5 depends from claim 1. It is also noted with respect to the “optionally wherein” portion of claim 5 that, since this is optional in claim 5, it will be treated as not being required by the claim. Claim 38 is dependent from claim 5 and therefore contains the same issues.
Claim 6 is rejected because the phrase “may be markable or be pre-disposed with a reference marking…” means that it also may not be markable/pre-disposed. In other words, this presents the option of “it is” or “it is not”. Based on this, the claim is unclear as to what is truly required. This Office action will take the position that this presents the option of “it may, or may not, be”.
Claim 7 is rejected because the phrase “configured to support both posterior each knee of the subject” appears to be grammatically incorrect, and it is unclear what this is intended to mean.
Claim 8 is rejected because the phrase “each knee posterior” is grammatically unclear. Also, the repeated “optionally” language creates uncertainty as to claim scope. For purposes of this Office action, the optional aspects will be treated as not being required by the claim.
Claim 9 is rejected because the phrase “via linkage fuse” is grammatically incomplete and lacks an article. Additionally, “working load” and “abusive load” are terms of degree that may lack objective boundaries in the claim.
Claim 39 is rejected because its preamble begins with “The steering guide according to claim 38”, when it should read “The radiotherapy treatment system…”.
Claim 43 is rejected because “the inserter elongated member lumen” lacks antecedent basis. Additionally, in the phrase “an image capture system configured to captures images”, the word “captures” should not be plural.
Claim 44 is rejected because “the controller” lacks antecedent basis because claim 1 recites a processing unit, not a controller. Also, the word “optionally” creates uncertainty as to whether orientation information is part of the claimed system. For purposes of this Office action, the optional aspects will be treated as not being required by the claim.
Claim 47 is rejected because the words/ phrases “in particular” (see lines 5 10) and “preferably” (see lines 5 and 11) make the claim unclear. Specifically it is unclear if the passages that follow each of these are actually required by the claim. Also, the word “optionally” (see the last line) makes the remainder of this language non-required. For purposes of this Office action, the optional aspects will be treated as not being required by the claim. Finally, “ans” in line 6 should read “and”, or “and/or”, or something else entirely.
Claim 47 is rejected because it is unclear what exactly the distinction is between “the radiation treatment table” versus “a simulation table”. More specifically, it is unclear if these are two distinct tables, and if so, then what the difference is between them, since both have or are capable of having the RA attached/mounted to them, both are claimed as having “a measurement gauge”, etc. The discussion in claim 47 of “for determining one or more empirically-determined simulation poses of the positioning tool” is an intended use of the simulation table and does not structurally define any aspect of the table that differentiates it from “the radiation treatment table”. The word “ans” between these two is unclear as indicated above. For purposes of this Office action, these will be interpreted as being capable of being a single table that is simply used for both purposes.
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.
Claims 1-2 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Omori (US Patent Pub. No. 2010/0331859) alone.
Omori discloses “a medical robot system which includes a medical manipulator capable of handling organs such as a uterine of different shapes and sizes” (see Abstract). Specifically, Omori teaches a system comprising:
a robotic arm, RA (see robotic arm in Figure 1 having joints 24, 44 and 46) having a base end (see side of robotic arm labeled with 46 and base structure 16 to which it is attached) an effector end (see side of robotic arm labeled with 44), wherein
the base end is mounted on or mountable in fixed relation to a radiotherapy treatment table for treating a subject (see Figure 1, illustrating the robotic arm in fixed proximity to patient treatment table 14),
the effector end is posed with a RA fitting for dismountable attachment to a positioning tool (see unit 50 in Figure 2; see paragraph 38 for teaching “uterine manipulator 34 is detachably provided onto a slider 50 of the front end of robot arm 24”) having a proximal and distal end (see proximal end attached to structure 34 in Figure 2, see distal end with label 124 in Figure 2),a nd
a processing unit comprising at least one processor and a memory, wherein the processing unit is configured to control and fix movement of the robotic arm, RA, during the external radiotherapy treatment session (see console unit 26 in Figure 1, where “console 26 which performs general control of the entire system” (see paragraph 32), and it is noted that it would be obvious to one of ordinary skill in the art that controller/console unit 26 comprises a processor and memory containing the software to control the robotic arms), and
the positioning tool comprising:
a steering guide (see entire surgical instrument illustrated in Figure 2) having a proximal and distal end (see right side of the instrument generally labeled 34 in Figure 2 for proximal end; see left side of the instrument generally labeled 64 in Figure 2 for distal end), comprising:
a rigid effector shaft at the distal end configured for insertion into the canal of the subject (see 64 in Figures 2 and 7, illustrated in Figure 7 fully inserted into the uterus and adjusting the position of the uterus), [the “or for attachment to an inserter…” in the claim makes the second portion here optional, therefore it is not discussed herein, since the first option is met],
a rigid handle portion disposed at the proximal end in fixed relation to the effector shaft (see numeral 58 in Figure 7) for controlling the position and/or direction of the effector shaft and configured for attachment to the RA fitting (see numeral 58 in Figure 7, note that in Figure 2 this portion contains structures for controlling the position and/or direction of the effector shaft, and configured for attachment to the RA fitting),
a rigid transmission joining the handle portion to the effector shaft (see 60 in Figures 2 and 7), wherein the positioning tool is configured to move and/or fix the canal for the external radiotherapy treatment session responsive to movements of the robotic arm (it is noted that movement of the robotic arm will inherently result in movement of the entire uterine manipulator, and this type of movement is inherently part of the overall process of moving/fixing the uterus during the treatment that is to be given).
With regard to the recitations of radiotherapy that are underlined in the above rejection, and with regard to all other claim system claims similarly reciting this subject matter, it is noted that this is the intended use of the overall system (i.e., to utilize the claimed system in radiotherapy session(s) versus other surgical procedures). However, the claim is a system claim. Section 2114(II) of the MPEP states (with emphasis in the original), “’Apparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).”Section 2114(II) of the MPEP states, “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987.” In this regard, it is noted that Omori teaches all of the structural components of the system as claimed, and could be used in a radiotherapy treatment session to properly position the uterus, as the intended function of the system of Omori is to position the uterus for treatment.
Regarding claim 2, Figure 1 illustrates the robotic arm under control of console 26 having been positioned such that the uterine manipulator is in a treatment pose. Figure 7 illustrates the uterine manipulator at a specific treatment pose, in which it is lifting the uterus. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that if and when the system of Omori is used in a radiotherapy treatment, that the uterus would be positioned via the uterine manipulator, via control of the robotic arm as controlled by console 26, into a proper position for the radiotherapy treatment.
Regarding claim 41, Figures 2 and 7 illustrate balloon 92. This balloon is taught as being expanded in order to fix the balloon and the overall device to the uterus. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that this balloon is inflatable and deflatable based on the first sentence of paragraph 67, and also that this would be deflated upon delivery of the device through the vagina and into the uterus, since inflating this balloon prior to this step would be unnecessarily uncomfortable for the patient. This reads on lines 2-5 of claim 41. Everything after line 5 in claim 41 is optional, based on the “and/or”, and therefore is not required by the claim.
Claims 3, 5 and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Omori as applied to claim 1 above, and further in view of Jarc et al. (US Patent Pub. No. 2016/0314710).
Omori is described above with respect to claim 1. However, Omori fails to teach a simulation in which one or more treatment poses from one or more empirically-determined simulation poses of the positioning tool are determined.
Regarding claim 3, Jarc teaches a simulator system for medica procedure training (see Title) and teaches the use of a uterine manipulator in paragraphs 81, 109 and 167. In paragraph 65, Jarc teaches that “the simulation processing component receives and records signals indicating that the user is positioning one or more components of the simulation system… the component positions can be tracked using sensors, such as sensors for cameras positioned over the physical simulation area, sensors detecting the motion of the components, etc., and these positions can be sent to, monitored and recorded by the simulation processing component 102.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a simulation for the use of a uterine manipulator, as taught by Jarc, with the system of Omori in order to determine metrics “from recorded parameters and can include the times expended by an assistant for various tasks during the setup procedure, as well as a summary of the placement positions of the components and instruments used in the setup” (see paragraph 76 of Jarc). In doing so, this will “beneficial to quantify training and performance of such tasks by surgeons and assistants, thereby enabling such personnel to track progress and improve performance” (see paragraph 5 of Jarc).
Regarding claim 5, Jarc taches that “The simulation processing component 102 can record parameters such as the received signals and times taken to complete tasks, and can output signals causing feedback to be provided during this block. For example, feedback can include a visual and/or audio displaying of instructions as to placement, graphical spatial diagrams or maps of actual and/or desired component placement, alerts when the user has deviated too much from appropriate placement, warnings when specific measures are not taken (e.g., moving the patient side cart without placing the arms up), etc.” (see paragraph 65). Additionally, “Some implementations can output real-time feedback during the task performance, such as indicators of correct or incorrect sutures, instrument positions, hints to the trainee, etc. Some real-time feedback can be instructional, indicating how instruments should be placed, moved, or positioned” (see paragraph 106). Therefore, Jarc teaches to provide/receive real-time feedback as to the in-situ pose of the positioning tool(s) after the pose of the positioning tool has been adjusted to correspond with one or more empirically-determined simulation poses of the tool(s), as claimed. That is, the system knows the correct positions within the simulation, and feedback is provided to the users of the simulation in real-time as stated in paragraph 106. Additionally, paragraphs 65 and 106 both teach real-time manual, automatic or semi-automatic guidance to fine-tune the pose.
Regarding claims 38-39, it is noted that Jarc teaches that “Other types of sensors instead of cameras can be used in other implementations. For example, electromagnetic sensors, other optical sensors, etc. can be used to sense cannulas and manual surgical instruments” (see paragraph 170). This teaches the use of “transponders”, as electromagnetic sensors used for determining position are transponders, and it is known that electromagnetic sensors require an electromagnetic source to determine the field strengths in order to determine their position (i.e., a transponder reader). Similarly, “optical sensors” require an optical imager to determine their position in the operative field. Finally, paragraph 169 teaches that “the positions of teleoperated surgical instruments are already known based on sensors in the teleoperated arms”, which also teaches tracking transponders.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Omori as applied to claim 1 above, and further in view of Zhou et al. (CN 204428630 U).
Omori is described above with respect to claim 1. However, Omori fails to teach knee supports as disclosed, although it is noted that Omori does illustrate knee supports in general within Figure 1.
Zhou teaches “a bed for cervical cancer radiotherapy, comprising a treatment bed, the treatment bed is provided with a dilator device, vaginal fixing device through the sliding device is mounted on a treatment bed” (see Abstract). As illustrated in Figures 1, the system of Zhou includes a patient table 1, along with knee supports 4 each having a body (see top portion) with a base end (see extensions on which top portions reside) and opposing supporting side (see thin sides of top portions) configured to support both posterior each knee of the subject (see Figure 1). These knee supports are capable of being removed, since they were mounted to the table during manufacture, therefore they could be removed that is the intention. In Figure 1, it can be seen that dilator fixing device is positioned therebetween the knee supports for insertion into the patient.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the knee support device taught by Zhou as a functional equivalent to that taught in Figure 1 of Omori, because 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 yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Omori as applied to claim 1 above, and further in view of Furst et al. (US Patent No. 6,245,028).
Omori is described above with respect to claim 1. However, Omori fails to teach a linkage fuse that releases based on an abusive load.
Furst teaches “a mechanical needle biopsy system includes a robotic arm adjustably mounted to the subject support. The robotic arm inserts and retracts the biopsy needle into and out of the subject and senses forces acting on the biopsy needle” (see column 3, line 65 through column 4, line 2). At column 10, lines 30-38, Furst teaches the following:
Another fail-safe feature optionally incorporated in the image-guided needle biopsy system 10 guards against subject injury caused by an unwanted shifting of the subject 20. Under these circumstances, the subject 20 may be injured when the biopsy needle 210 is not free to move with the subject 20. Accordingly, to reduce this risk, both quick release connections or couplings 270 and 284 are made to automatically disengage and/or separate when subjected to a shear force or pressure greater than an acceptable threshold.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a fail safe such that if the patient moves too much while the uterine manipulator device of Omori is inserted within the uterus of the patient, it will detach and follow the patient as opposed to the robotic arm, as taught by Furst with regard to the biopsy needle. In doing so, this will ensure patient safety and comfort. It is noted that the “and/or” in the second to last line of claim 9 is interpreted as “or”, therefore the last line of claim 9 need not be taught by prior art.
Claims 40 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Omori as applied to claim 1 above, and further in view of Zhang et al. (CN 111803809 A).
Omori is described above with respect to claim 1. However, Omori fails to teach an “inserter” which comprises an elongated member that is attached or dismountably attachable with the effector shaft.
Regarding claim 40, Zhang teaches a vaginal cervical fixing device and cervical tumour treatment system (see Abstract). Figures 10 and 11 illustrate two distinct options for the vaginally inserted tool. In Figure 10, the tool is a single device, whereas in Figure 11 it shows a “split type, one section is vagina inner section 407, one section is uterine body inner section 408”, where the uterine body inner section 408 may be detachably connected to the remainder of the tool.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a removable end section, as taught by Zhang, and to use this configuration within the system and methods of Omori, because 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 yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Regarding claim 47, Zhang a uterine manipulator device (see numeral 400 in Figure 1) which is attached to a patient table 600. As shown in Figure 1, the location where the vertical rod that connects with the table comprises a measurement gauge for determining a position of the tool holding device with respect to the table, and therefore to a patient positioned on the table. Based on the rejection under 35 USC 112(b) above with respect to this claim, it is re-iterated that for purposes of this Office action, these will be interpreted as being capable of being a single table that is simply used for both purposes.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Omori as applied to claim 1 above, and further in view of Diederich et al. (US Patent Pub. No. 2003/0114878).
Omori is described above with respect to claim 1. However, Omori fails to teach that the uterine manipulator is MRI compatible, visible in MR, or contains one or more MRI visible markers.
Diederich teaches “an apparatus and method for shielding non-target tissues and organs during thermotherapy, brachytherapy or other treatment of a diseased target tissue. The apparatus includes a catheter shaft having input and output lumens and at least one inflatable balloon… The catheter is positioned between the target tissue or organ and sensitive non-target tissues in proximity to the target tissue and inflated causing a physical separation of tissues as well as a physical shield” (see Abstract; see paragraph 15 which discusses treatment of gynecological diseases, such as uterine and cervical cancer, and paragraph 16 for mentioning usefulness in external beam radiation therapies). “The insertion of the catheter 10 and the balloon inflation may be monitored using ultrasonic diagnostic imaging, CT fluoroscopic imaging, magnetic resonance imaging (MRI), or other appropriate means for visualization known in the art” (see paragraph 53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize medical imaging techniques such as MRI for determining the location of a catheter used for positioning target tissues in external beam radiation therapies or many others as disclosed by Diederich, within the system and methods of Omori in order to monitor the insertion of the uterine manipulator (see last sentence of paragraph 53 of Diederich). It is also noted that if MRI is used to monitor the insertion of the catheter, then this implies that the catheter is compatible with MRI, as well as that the catheter will be visible in the MR image.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Omori as applied to claim 1 above, and further in view of Prior et al. (US Patent Pub. No. 2021/0282871, having priority to provisional application 62/987,812 with date March 10, 2020).
Omori is described above with respect to claim 1. However, Omori fails to teach an imaging unit at the distal end of the uterine manipulator.
Prior teaches a “surgical robotic system includes an image capturing device, a surgical console, a multi-directional indicator, a surgical instrument, and a control tower” (see Abstract). Figure 2 illustrates a surgical instrument that is placed through the vagina and into the uterus. “The surgical instrument 51 may be a camera configured to capture video of the surgical site “S” (FIG. 3). The camera 51 may be a stereoscopic camera and may be disposed along with the surgical instrument 50 on the robotic arm 40” (see paragraph 39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to incorporate a camera at the distal end of a uterine manipulator, as explicitly taught by Prior, within the system and methods of Omori in order to ensure proper placement of the manipulator during insertion.
Allowable Subject Matter
Claims 45-46 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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