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 “one or more resilient members operably coupled to said mechanism” of claim 18 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Objections
Claims 1, 2, 6, 12, and 13 are objected to because of the following informalities:
In claim 1, line 6, “simulate a medical” should read “simulate the medical” as the limitation has antecedence in line 1.
In claim 1, line 9, “wherein” should be deleted as it is grammatically incorrect as written.
In claim 2, line 2, “said distal end” should read “said distal end of said handpiece”.
In claim 6, line 2-3, “to said proximal end” should read “to said proximal end of said handpiece”.
In claim 12, line 1, “a mechanism” should read “the mechanism” as claim 12 depends from claim 1.
In claim 12, line 1, “a handpiece” should read “said handpiece”.
In claim 12, line 1, “a medical” should read “said medical”.
In claim 12, line 2, “a haptic arm” should read “said haptic arm”.
In claim 12, line 2, “a medical simulator” should read “said medical simulator”.
In claim 12, line 7, “a first parallel” should read “said first parallel”.
In claim 12, line 8, “a second four-bar” should read “said second parallel four-bar”.
In claim 13, line 2, “at a common” should read “at said common”.
In claim 13, line 2, “said distal end” should read “said distal end of said handpiece”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites the limitation “a remote common center of rotation for a plurality of axes for said handpiece”. The specification does not provide a definition or explanation of the limitation beyond reciting the claim limitation verbatim. The lack of description in the specification means one of ordinary skill in the art would not be able to ascertain what applicant regards as “a remote common center of rotation” and if this is the same as or different from the “common point” recited in claim 1. Therefore, one of ordinary skill in the art would not reasonably ascertain that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
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 1-19 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.
Regarding claim 1, line 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2-19 are rejected by virtue of their dependency from claim 1.
Regarding claim , the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 3, in line 2, recites the limitation “a remote common center of rotation” which is not defined in the claim or specification and is not a common term of art. Further, it is unclear if the limitation is the same or different from the “common point” recited in claim 1. Therefore, the limitation renders the claim indefinite, and one of ordinary skill in the art would not be able to determine the subject matter which the inventor or a joint inventor regards as the invention.
Claim 5 is rejected by virtue of its dependency from claim 3.
Regarding claim 5, line 4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 recites the limitation "the longitudinal axis" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7, line 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites the limitation "said first revolute joint" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the rotary position" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "said first arm" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10, line 2, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 10, lines 4-5, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation “said jaw angle not exceeding 55°”, and the claim also recites “preferably not exceeding 50°” and “preferably not exceeding 45°” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 10, line 6, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 11, lines 3-4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Additionally, the use of See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation “said open position not exceeding 55°”, and the claim also recites “preferably not exceeding 50°” and “preferably not exceeding 45°” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 16 recites the limitation "said first pair of links" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "said second pair of links" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the direction" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the links of said first pair of links" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 is written in narrative form stating “said mechanism is equipoised by one or more resilient members operably coupled to said mechanism”. It is unclear what the structural elements are including how and where the “resilient members” are connected to said mechanism and how they are used to equipoise the mechanism. Therefore, one of ordinary skill in the art would not be able to reasonably determine the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 18, line 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6, 9, 12-14, 16, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karssen et al. (US PGPub 20170278427), hereinafter referred to as Karssen, in view of Hongo et al. (US PGPub 20190053863), hereinafter referred to as Hongo.
With regard to claim 1, Karssen teaches a medical procedure simulator for simulating a medical treatment or procedure (Abstract; Paragraph 0024 teach a medical simulator for simulating a medical procedure or treatment), said medical procedure simulator comprising:
a handpiece with a proximal end and a distal end (Abstract; Fig. 2, Ref 112; Paragraphs 0026-0027 teach the system includes a handpiece shown with two ends (distal and proximal)),
said handpiece being configured to be manipulated by a user in a workspace in real space (Abstract; Paragraph 0009 teach the user can manipulate the handpiece in a real space),
a haptic arm controlled by a computer that is configured to simulate a medical procedure or treatment through haptic feedback, preferably haptic force feedback, to said handpiece with said haptic arm (Abstract; Figs. 2, 31; Paragraphs 0026, 0028, 0030, 0033, 0044 teach the system includes three pushrods including a third pushrod (haptic arm) driven by three motors controlled by the computer to provide haptic feedback and simulate the medical procedure wherein the motors drive the pushrods and thereby drive the handpiece providing haptic force feedback).
Karssen further teaches the handpiece is connected by a gimbal to allow for rotation in three degrees of freedom and the gimbal and handpiece are connected to the linkage/pushrod by a gimbal member and gimbal mount allowing for the degrees of freedom (Paragraphs 0027, 0035-0036) but may not explicitly teach wherein a mechanism connected to said proximal end of said handpiece and connected to said haptic arm at a connection position on said haptic arm, said mechanism comprising a first parallel four-bar linkage coupled to a second parallel four-bar linkage, said mechanism being configured to allow said handpiece to rotate about three orthogonal axes that intersect through a common point in said workspace, and said common point being a fixed position relative to said connection position so that said common point moves in unison with said connection position. However, Hongo teaches a support arm device (mechanism) for a medical tool (handpiece) wherein the support arm device is connected to a proximal end of the medical tool and connected to a base (connection position) including three motors for rotating the support arm about three orthogonal axes such that the device has a remote center of motion (RCM) (common point) around which the device rotates about the three axes wherein said RCM is a fixed distance from the base (connection position) wherein the device includes two four-bar linkages in the form of parallelograms that are coupled to each other (Figures 1, 2, 4-6, 16, 18, 25; Paragraphs 0063-0064, 0072, 0074, 0077, 0083, 0089, 0133, 0178).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen to incorporate the teachings of Hongo by combining the elements of Hongo with Karssen by substituting the support arm device of Hongo for the handpiece mount of Karssen, as both references and the claimed invention are directed to medical devices/simulators including mounted medical devices. One of ordinary skill in the art would modify Karssen by attaching the medical device/handpiece to the support arm device of Hongo by a first end of the first parallelogram/four-bar linkage via the gimbal and attaching the other end of the support arm via the second parallelogram to the third pushrod in place of the motors of Hongo using the gimbal mount of Karssen thereby allowing for the system to have a remote center of motion/common point a fixed distance from the gimbal mount/connection position and three orthogonal axes of rotation about the RCM. One of ordinary skill in the art would have made the modification using known techniques including the gimbal mounting to provide three degrees of freedom in order to yield the expected result of a remote center of motion for the attached medical device. Upon such modification, the method and system of Karssen would include wherein a mechanism connected to said proximal end of said handpiece and connected to said haptic arm at a connection position on said haptic arm, said mechanism comprising a first parallel four-bar linkage coupled to a second parallel four-bar linkage, said mechanism being configured to allow said handpiece to rotate about three orthogonal axes that intersect through a common point in said workspace, and said common point being a fixed position relative to said connection position so that said common point moves in unison with said connection position. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Hongo with Karssen’s system and method in order to improve surgical instrument insertion and movement by providing improved degrees of freedom and ability to operate the medical device away from the motors/mount (Hongo Paragraph 0115).
With regard to claim 2, Karssen may not explicitly teach wherein said common point substantially coincides with said distal end. However, as discussed above, Hongo further teaches a remote center of motion (RCM) which is shown as coinciding with the distal end of the medical/surgical tool (Figures 1, 2, 10, 13, 15; Paragraphs 0063-0064). As discussed above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen to incorporate the teachings of Hongo by combining the elements of Hongo with Karssen by substituting the support arm device including a remote center of motion coinciding with a distal end of the handpiece/surgical tool of Hongo for the handpiece mount of Karssen. Upon such modification, the method and system of Karssen would include wherein said common point substantially coincides with said distal end. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Hongo with Karssen’s system and method in order to improve surgical instrument insertion and movement by providing improved degrees of freedom and ability to operate the medical device away from the motors/mount (Hongo Paragraph 0115).
With regard to claim 3, as discussed above, Karssen, as modified, in view of Hongo teaches wherein said mechanism provides a remote common center of rotation for a plurality of axes for said handpiece (Hongo Figures 1, 2, 10, 13, 15; Paragraphs 0063-0064, 0072, 0074, 0083).
With regard to claim 4, Karssen may not explicitly teach wherein said first parallel four-bar linkage is operatively coupled with said second parallel four-bar linkage to allow rotation of said handpiece about a second axis coinciding with said common point. However, as discussed above, Hongo teaches a support arm device (mechanism) for a medical tool (handpiece) wherein the first parallelogram (parallel four-bar linkage) (Refs 11a,b) is connected to the second parallelogram (Refs 15a,c and 17a,c) allowing for movement in a front-rear direction (second axis) thereby rotating around the RCM (Figs. 5, 13, 15; Paragraphs 0063-0064, 0085, 0109).
As discussed above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen to incorporate the teachings of Hongo by combining the elements of Hongo with Karssen by substituting the support arm device of Hongo for the handpiece mount of Karssen, as both references and the claimed invention are directed to medical devices/simulators including mounted medical devices. One of ordinary skill in the art would modify Karssen by attaching the medical device/handpiece to the support arm device of Hongo by a first end of the first parallelogram/four-bar linkage via the gimbal and attaching the other end of the support arm via the second parallelogram to the third pushrod in place of the motors of Hongo using the gimbal mount of Karssen thereby allowing for the system to have a remote center of motion/common point a fixed distance from the gimbal mount/connection position and three orthogonal axes of rotation about the RCM including front and rear direction (second axis) movement and rotation about the RCM based on the connection between the bars/first and second parallelograms. One of ordinary skill in the art would have made the modification using known techniques including the gimbal mounting to provide three degrees of freedom in order to yield the expected result of a remote center of motion for the attached medical device. Upon such modification, the method and system of Karssen would include wherein said first parallel four-bar linkage is operatively coupled with said second parallel four-bar linkage to allow rotation of said handpiece about a second axis coinciding with said common point. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Hongo with Karssen’s system and method in order to improve surgical instrument insertion and movement by providing improved degrees of freedom and ability to operate the medical device away from the motors/mount (Hongo Paragraph 0115).
With regard to claim 5, Karssen may not explicitly teach wherein said second parallel four-bar linkage is connected to said haptic arm by a second revolute joint, said second revolute joint allowing rotation about third axis parallel with the extent of said haptic arm, and said third axis preferably coinciding with said common point. However, as discussed above, Hongo teaches a support arm device (mechanism) for a medical tool (handpiece) wherein the second parallelogram (parallel four-bar linkage) (Refs 15a,c; 17a,c) is connected to the base via a drive shaft (revolute joint) allowing for movement in a left-right direction (third axis) thereby rotating around the RCM (Figs. 18, 19; Paragraphs 0061, 0063-0064, 0112, 0113, 0115-0116).
As discussed above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen to incorporate the teachings of Hongo by combining the elements of Hongo with Karssen by substituting the support arm device of Hongo for the handpiece mount of Karssen, as both references and the claimed invention are directed to medical devices/simulators including mounted medical devices. One of ordinary skill in the art would modify Karssen by attaching the medical device/handpiece to the support arm device of Hongo by a first end of the first parallelogram/four-bar linkage via the gimbal and attaching the other end of the support arm via the second parallelogram to the third pushrod in place of the motors of Hongo using the gimbal mount of Karssen thereby allowing for the system to have a remote center of motion/common point a fixed distance from the gimbal mount/connection position and three orthogonal axes of rotation about the RCM including left and right direction (third axis) movement and rotation about the RCM based on the connection between the second parallelogram and the gimbal mount (revolute joint) connected to the third pushrod (haptic arm). One of ordinary skill in the art would have made the modification using known techniques including the gimbal mounting to provide three degrees of freedom in order to yield the expected result of a remote center of motion for the attached medical device. Upon such modification, the method and system of Karssen would include wherein said second parallel four-bar linkage is connected to said haptic arm by a second revolute joint, said second revolute joint allowing rotation about third axis parallel with the extent of said haptic arm, and said third axis preferably coinciding with said common point. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Hongo with Karssen’s system and method in order to improve surgical instrument insertion and movement by providing improved degrees of freedom and ability to operate the medical device away from the motors/mount (Hongo Paragraph 0115).
With regard to claim 6, Karssen, as modified, further teaches wherein said mechanism comprises a first arm that is connected to said proximal end by a revolute joint that allows said handpiece to rotate about a first axis that coincides with the longitudinal axis of said handpiece (Paragraphs 0037-0038 teach the handpiece/surgical tool is attached at a proximal end of the handpiece/tool using a gimbal and rotational joint (revolute joint) allowing for free rotation in three degrees of freedom including an LZ axis (longitudinal axis) coinciding with the handpiece/tool), said first arm preferably being part of a first pair of parallel arms of said first parallel four-bar linkage (Hongo Fig 2 shows the handpiece/tool connected via the support piece (Ref 50) which corresponds with the third link (Ref 13) as part of the first parallelogram as a first pair).
With regard to claim 9, Karssen, as modified, further teaches wherein an inertial measurement unit is arranged inside said handpiece (Paragraph 0039 teaches the handpiece includes an IMU for measuring acceleration and velocities of the handpiece and is positioned within the body of the handpiece).
With regard to claim 12, Karssen, as modified, in view of Hongo teaches a mechanism for connecting a handpiece of a medical simulator to a haptic arm of a medical simulator according to claim l (see prior art rejection of claim 1 above), said mechanism comprising: a first arm for connecting to said handpiece via a first revolute joint, said first revolute joint allowing said handpiece to rotate about a first axis that coincides with a longitudinal axis of said handpiece (see prior art rejection of claim 6 above), said first arm being part of a first parallel four-bar linkage, said first parallel four-bar linkage being operably connected to a second four-bar linkage to allow said handpiece to rotate about a second axis (see prior art rejection of claim 4 above), said second parallel four-bar linkage comprising a third arm for connecting to said haptic arm via a second revolute joint (154), said second revolute joint allowing said handpiece to rotate about a third axis that is preferably parallel with said haptic arm (see prior art rejection of claim 5 above).
With regard to claim 13, Karssen, as modified, in view of Hongo teaches wherein said first, second, and third axis subtstantially coincide at a common point at or near said distal end (see prior art rejection of claim 2 above).
With regard to claim 14, Karssen, as modified, in view of Hongo teaches wherein said first, second, and third axes intersect at a position in space that is fixed relative to said second revolute joint, and at a fixed distance to said second revolute joint (see prior art rejection of 2 and 3 above).
With regard to claim 18, Karssen may not explicitly teach wherein said mechanism is equipoised by one or more resilient members operably coupled to said mechanism, said resilient members preferably being long elastic cords or cables. However, Hongo further teaches the support arm includes compensating springs for assisting the arm part in self-standing (equipoised) (Paragraph 0100).
As discussed above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen to incorporate the teachings of Hongo by combining the elements of Hongo with Karssen by substituting the support arm device of Hongo for the handpiece mount of Karssen, as both references and the claimed invention are directed to medical devices/simulators including mounted medical devices. One of ordinary skill in the art would modify Karssen by attaching the medical device/handpiece to the support arm device of Hongo by a first end of the first parallelogram/four-bar linkage via the gimbal and attaching the other end of the support arm via the second parallelogram to the third pushrod in place of the motors of Hongo using the gimbal mount of Karssen thereby allowing for the system to have a remote center of motion/common point a fixed distance from the gimbal mount/connection position and three orthogonal axes of rotation about the RCM including left and right direction (third axis) movement and rotation about the RCM based on the connection between the second parallelogram and the gimbal mount (revolute joint) connected to the third pushrod (haptic arm) wherein the connection points would include compensating springs to provide reaction forces to assist in self-standing the system and maintaining balance. One of ordinary skill in the art would have made the modification using known techniques including the gimbal mounting to provide three degrees of freedom in order to yield the expected result of a remote center of motion for the attached medical device. Upon such modification, the method and system of Karssen would include wherein said mechanism is equipoised by one or more resilient members operably coupled to said mechanism, said resilient members preferably being long elastic cords or cables. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Hongo with Karssen’s system and method in order to improve surgical instrument insertion and movement by providing improved degrees of freedom and ability to operate the medical device away from the motors/mount (Hongo Paragraph 0115) and maintain the system in a self-standing configuration using compensating springs.
With regard to claim 19, Karssen, as modified, further teaches wherein said first parallel four-bar linkage and/or said second parallel four-bar linkage are enveloped by a covering (Paragraph 0024 teaches the system includes a housing). Assuming in arguendo the housing does not “envelope” the linkages, Hongo further teaches the device my have a cover as a housing containing the support arm device (Paragraphs 0066-0067; Fig 1, Ref 201).
As discussed above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen to incorporate the teachings of Hongo by combining the elements of Hongo with Karssen by substituting the support arm device of Hongo for the handpiece mount of Karssen, as both references and the claimed invention are directed to medical devices/simulators including mounted medical devices. One of ordinary skill in the art would modify Karssen by attaching the medical device/handpiece to the support arm device of Hongo by a first end of the first parallelogram/four-bar linkage via the gimbal and attaching the other end of the support arm via the second parallelogram to the third pushrod in place of the motors of Hongo using the gimbal mount of Karssen thereby allowing for the system to have a remote center of motion/common point a fixed distance from the gimbal mount/connection position and three orthogonal axes of rotation about the RCM including left and right direction (third axis) movement and rotation about the RCM based on the connection between the second parallelogram and the gimbal mount (revolute joint) connected to the third pushrod (haptic arm) wherein at least part of the support arm/device is housed in a covering. One of ordinary skill in the art would have made the modification using known techniques including the gimbal mounting to provide three degrees of freedom in order to yield the expected result of a remote center of motion for the attached medical device. Upon such modification, the method and system of Karssen would include wherein said first parallel four-bar linkage and/or said second parallel four-bar linkage are enveloped by a covering. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Hongo with Karssen’s system and method in order to contain and protect the system and prevent an operator from mistakenly touching the arm part and being injured (Hongo Paragraph 0066).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karssen in view of Hongo as applied to claim 1 above, and further in view of Lammertse (US 8,716,973).
With regard to claim 7, Karssen further teaches wherein said haptic arm comprises linkage comprising a main link that is operably coupled to a reference by actuators (Fig. 2, refs 138, 146, 152, 154; Paragraphs 0026, 0028-0031 teach the system includes a third pushrod (main link) that is connected to the handpiece via the gimbal mount and is connected to the three motors (actuators) via links (reference)). Karssen further teaches detecting movement and metrics using an IMU within the handpiece (Paragraph 0039).
Karssen in view of Hongo may not explicitly teach said main link comprising a three-dimensional force sensor for sensing forces applied by said user to said handpiece in three dimensions, said three-dimensional force sensor being disposed between said connection position and any position at which said actuators connect to said main link, and said three-dimensional force sensor preferably being an integral part of said main link. However, Lammertse teaches a haptic user interface for a user connection element (surgical tool) wherein the haptic arm has a first linkage including three force sensors for sensing forces applied by a user to the element in three dimensions (Abstract; Col 1, line 43 – Col 2, line 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen in view of Hongo to incorporate the teachings of Lammertse by applying the teaching of the force sensor being in the linkage/haptic arm of Lammertse to the IMU of Karssen, as both references and the claimed invention are directed to medical devices/simulators including mounted medical devices providing haptic feedback. One of ordinary skill in the art would modify Karssen in view of Hongo by including force sensors and/or an additional IMU within the third pushrod (main link) between the connections with the motors and the gimbal mount (connection point) to detect three dimensional force data. Upon such modification, the method and system of Karssen in view of Hongo would include said main link comprising a three-dimensional force sensor for sensing forces applied by said user to said handpiece in three dimensions, said three-dimensional force sensor being disposed between said connection position and any position at which said actuators connect to said main link, and said three-dimensional force sensor preferably being an integral part of said main link. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Lammertse with Karssen in view of Hongo’s system and method in order to further detect user interactions with the system as the location of the sensor would be obvious to one of ordinary skill in the art to try to detect forces exerted on the system.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karssen in view of Hongo as applied to claim 1 above, and further in view of Casals Gelpi et al. (US PGPub 20180366034), hereinafter referred to as Casals.
With regard to claim 8, Karssen in view of Hongo may not explicitly teach wherein said first revolute joint is provided with a rotary position sensor for sensing the rotary position of said handpiece relative to said first arm. However, Casals teaches a device for simulating an endoscopic operation using a haptic system including a haptic arm wherein each connection point can include a rotation sensor including the connection between the connection between the endoscope tool and the third bar/connection to the arm (Abstract; Paragraphs 0031, 0057).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen in view of Hongo to incorporate the teachings of Casals by including a rotation sensor of Casals at the gimbal/rotational joint of Karssen, as both references and the claimed invention are directed to medical devices/simulators including mounted medical devices providing haptic feedback. One of ordinary skill in the art would modify Karssen in view of Hongo by including a rotation sensor where the tool/handpiece connections to the rotational joint to collect rotation data. Upon such modification, the method and system of Karssen in view of Hongo would include wherein said first revolute joint is provided with a rotary position sensor for sensing the rotary position of said handpiece relative to said first arm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Casals with Karssen in view of Hongo’s system and method in order to further detect user interactions with the system and accurately monitor the position and orientation of the surgical tool/handpiece (Casals Paragraph 0057).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karssen in view of Hongo as applied to claim 1 above, and further in view of Nakano et al. (US PGPub 20190333414), hereinafter referred to as Nakano as evidenced by Ingwersen (US 1,711,947) and Muto et al. (“Linear and angular measurements of the mandible during maximal mouth opening” NPL).
With regard to claims 10 and 11, Karssen in view of Hongo may not explicitly teach comprising a phantom upper jaw and a phantom lower jaw, preferably as a part of a phantom head, said phantom lower jaw being arranged at a jaw angle to said phantom upper jaw, said jaw angle not exceeding 55°, preferably not exceeding 50° and even more preferably not exceeding 45°, and said connection position being located, inferior, preferably inferomedial to said lower jaw [claim 10] and wherein said lower jaw is arranged pivotable relative to said upper jaw between a closed position and an open position, the jaw angle at said open position not exceeding 55°, preferably not exceeding 50° and even more preferably not exceeding 45° [claim 11]. However, Nakano teaches a medical simulator including a human body model including a head with an oral cavity portion including a lower and upper jaw that can move (pivotable) between an open and close position wherein the range of rotation is approximately equivalent to the range in which the jaw joint of a human body can move (Abstract; Paragraphs 0079-0083, 0096) which is evidenced by Ingwersen and Muto as not exceeding 55° (Ingwersen Page 2, lines 73-83) and/or 45° (Muto Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen in view of Hongo to incorporate the teachings of Nakano by combining the medical simulator of Nakano with the medical simulator of Karssen by using the head/human body model of Nakano as the subject of the simulated medical procedure of Karssen, as both references and the claimed invention are directed to medical devices/simulators. One of ordinary skill in the art would modify Karssen in view of Hongo by simply placing the medical simulator of Nakano in the surgical field as the target of the simulated medical procedure and orienting the body such that the system of Karssen and the “connection position” are located inferior to the lower jaw of the model. Upon such modification, the method and system of Karssen in view of Hongo would include comprising a phantom upper jaw and a phantom lower jaw, preferably as a part of a phantom head, said phantom lower jaw being arranged at a jaw angle to said phantom upper jaw, said jaw angle not exceeding 55°, preferably not exceeding 50° and even more preferably not exceeding 45°, and said connection position being located, inferior, preferably inferomedial to said lower jaw [claim 10] and wherein said lower jaw is arranged pivotable relative to said upper jaw between a closed position and an open position, the jaw angle at said open position not exceeding 55°, preferably not exceeding 50° and even more preferably not exceeding 45° [claim 11]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Nakano with Karssen in view of Hongo’s system and method in order to provide a realistic surgical simulation and provide further simulations.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karssen in view of Hongo as applied to claim 12 above, and further in view of Jaspers (US PGPub 20100121347).
With regard to claim 17, Karssen in view of Hongo may not explicitly teach wherein the links of said first pair of links are kinked. However, Jaspers teaches a manipulator for an instrument for minimally invasive surgery using a parallelogram construction wherein the parallel arms have kinks (Abstract; Paragraph 0039; Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Karssen in view of Hongo to incorporate the teachings of Jaspers by applying the teaching of the arms having bends/kinks of Jaspers to the first parallelogram of the support arm of Karssen in view of Hongo, as both references and the claimed invention are directed to medical devices/simulators. One of ordinary skill in the art would modify Karssen in view of Hongo by bending/kinking the links of the first parallelogram/link pair to a desired shape. Upon such modification, the method and system of Karssen in view of Hongo would include wherein the links of said first pair of links are kinked. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Jaspers with Karssen in view of Hongo’s system and method as such a change of shape would be obvious to one of ordinary skill in the art per MPEP 2144.04 in part to prevent collisions between the bars/links and other features and/or a patient/simulator target.
Conclusion
Accordingly, claims 1-19 are rejected.
Examiner notes that claim 15 is not rejected in view of the prior art as the closest art of record with regard to this limitation, Hongo, fails to teach “wherein said first pair of parallel arms is formed by said first arm and by an arm formed by an extension of one link of said second pair of parallel links” and “wherein said second pair of parallel arms is formed by said third arm and by an arm formed by an extension of one link of said first pair of parallel links”. No other searched or cited reference teaches the claimed limitations including the limitations from the claims which claim 15 depends. Even if such a reference was found teaching the specific limitation, it is not clear that sufficient motivation would exist for modifying Karssen in view of Hongo to teach the claimed limitations as a whole. Examiner recommends applicant correct the 112 rejections discussed above and incorporate the limitations of claim 15 and any intervening claims with the independent claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
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, Kang Hu can be reached at (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CORRELL T FRENCH/Examiner, Art Unit 3715
Prosecution Insights