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 .
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:
“tracking device … configured to be tracked…” in claim 29, line 2. Interpreted as a mechanical device shown in Fig. 3A [0115] and an optical, mechanical, or electromagnetic device [0118].
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and 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 Objections
Claim 29 is objected to because of the following informalities:
In claim 29, line 4, “associated a position” should read – associated with a position–.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 21 is rejected under 35 U.S.C. 101.
The claimed invention to Claim 21 reads on a human organism, because it positively recites “extends into the bone… when the bone pin is in the bone” in lines 5-6, and “when the lumen receives the bone pin and the distal tip of the barrel contacts the bone” in the “registration marker” para., lines 3-4. To overcome this rejection, the claim should be amended to recite, for example, –is configured to extend into the bone… when the bone pin is configured to be in the bone– and –when the lumen is configured to receive the bone pin and the distal tip of the barrel is configured to contact the bone–, respectively.
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.
Claim 21-40 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 pre-AIA the applicant regards as the invention.
Claims 21 and 35 recite “located approximately at the entry point” in lines 10 - 11 and 5-6, respectively. This limitation is indefinite because “approximately” is a relative term that is not defined in Applicant’s disclosure. For examination purposes, Examiner of record takes this to be “located at the entry point”.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 21, 25-32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Roose et al (US20090093816), hereinafter Roose, in view of van der Walt et al (US 20160242934), hereinafter Van der Walt, and Bonny et al (US 20180344409), hereinafter Bonny.
Regarding claim 21, Roose teaches a registration system (Figs. 120-123) for use in a medical procedure (“bone cuts” [0504]) on a bone (5202) (5268) of a patient (“an orthopaedic surgical procedure on a bone of a patient” [0005]; “The tibial cutting block 5200 also includes a number of pin guides 5208. In use, the pin guides 5208 are used as drill guides to establish guide pin holes in the tibia 5202 for securing a number of guide pins 5210 to the bone 5202.” [0504]; Fig. 120), the registration system comprising:
a bone pin clamp assembly (5200) (5250) comprising:
a body (5204) (5252) including a guide (5208) (5258) configured to receive a bone pin (5210) (5260) there through (“The cutting block 5250 includes a body 5252 having a bone-facing surface 5254 and an outer surface 5256. A number of guide pin holes 5258 are define in the body 5252 of the block 5250. A guide pin 5260 is received in each guide pin hole 5258 and configured to slide through the corresponding hole 5258 such that the guide pin 5260 is independently movable and positionable in any one of a number of positions relative to the body 5252. That is, each of the guide pins 5260 may be positioned such that a portion of the guide pin extends downwardly from the bone-facing surface 5254” [0507]; Figs. 120-122), the bone pin defining an entry point (5266) (points at the ends of vertical dot-dash lines in Fig. 120) at which the bone pin extends into the bone of the patient when the bone pin is in the bone (“The method may further include removing the customized patient-specific cutting block from the bone of the patient without removing the one or more surgical guide pins from the bone of the patient.” [0022]; “The pin guides 228 are used as drill guides to establish guide pin holes in the femur 204 of the patient” [0285]; “the pin guides 5208 are used as drill guides to establish guide pin holes in the tibia 5202 for securing a number of guide pins 5210 to the bone 5202.” [0504]; “the bone-contacting ends 5266 of the guide pins 5260” [0509]; Figs. 120-122).
While teaching a registration marker (each of the markers 5050 [0497]) (Fig. 117), Roose does not teach a barrel extending from the body to a distal tip, the barrel having a lumen extending along a longitudinal axis from the body to the distal tip, the lumen aligned with the guide such that the lumen is configured to receive the bone pin there through, the distal tip configured to contact the bone of the patient such that the distal tip is located approximately at the entry point; and
a registration marker defined on the body, wherein the longitudinal axis of the lumen is normal to a defined plane extending through the registration marker, a known distance defined between the defined plane and the distal tip of the barrel such that, when the lumen receives the bone pin and the distal tip of the barrel contacts the bone, a location of the entry point is defined along the longitudinal axis at the known distance from the defined plane.
However, in the surgical systems field of endeavor, Van der Walt discloses a hip replacement navigation system and method, which is analogous art. Van der Walt teaches a barrel (124) extending from the body (136) to a distal tip (near 128) (“The platform 136 comprises a rigid bar fixed to the proximal end of the pin 132 and/or the cannula 124” [0086]; seen in Figs. 1 and 3), the barrel having a lumen (a lumen of 124) extending along a longitudinal axis from the body to the distal tip (a longitudinal axis is the axis of the cannula 124 seen in Figs. 1 and 3), the lumen aligned with the guide such that the lumen is configured to receive the bone pin (132) there through, the distal tip configured to contact the bone of the patient such that the distal tip is located approximately at the entry point (“the cannula 124 is secured by a pin 132 (see FIG. 3) that is driven into the ilium on the pelvis through the cannula 124.” [0080]; seen in Figs. 1 and 3).
Therefore, based on Van der Walt’s teachings, 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 the invention of Roose to employ a barrel extending from the body to a distal tip, the barrel having a lumen extending along a longitudinal axis from the body to the distal tip, the lumen aligned with the guide such that the lumen is configured to receive the bone pin there through, the distal tip configured to contact the bone of the patient such that the distal tip is located approximately at the entry point, as taught by Van der Walt, in order to facilitate safer bone surgeries by limiting bone pin movement with a barrel.
Roose as modified by Van der Walt does not teach a registration marker defined on the body, wherein the longitudinal axis of the lumen is normal to a defined plane extending through the registration marker, a known distance defined between the defined plane and the distal tip of the barrel such that, when the lumen receives the bone pin and the distal tip of the barrel contacts the bone, a location of the entry point is defined along the longitudinal axis at the known distance from the defined plane.
However, in the surgical systems field of endeavor, Bonny discloses active robotic pin placement in total knee arthroplasty, which is analogous art. Bonny teaches a registration marker (212) defined on the body (204′), wherein the longitudinal axis of the lumen is normal to a defined plane extending through the registration marker (a plane perpendicular to 212 and to the longitudinal axis of 204′), a known distance defined between the defined plane and the distal tip of the barrel (a distance between the plane set by the fiducial marker array 212 and the distal tip on the left side of the working portion 204′ in Figs. 18B and 19A-B) such that, when the lumen (the lumen of the working portion 204′ in Figs. 18B, 19A-B ) receives the bone pin (206′) and the distal tip contacts the bone (Fig. 19B), a location of the entry point is defined along the longitudinal axis at the known distance from the defined plane (“A tracking array having a set of three or more fiducial markers rigidly attached the working portion to permit a tracking system to track a position and orientation (POSE) of the working portion.” [0011]; “the fiducial marker arrays (120a, 120b, 120c, 212) include three or more active emitters or passive reflectors uniquely arranged in a known geometry on each rigid body.” [0055]; “the working portion 204′ of the articulating pin driver device 104′ further includes components configured to drive a pin 206′ into a bone.” [0108]; Figs. 18B and 19A-B).
Therefore, based on Bonny’ teachings, 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 further modified the combined invention of Roose and Van der Walt to employ a registration marker defined on the body, wherein the longitudinal axis of the lumen is normal to a defined plane extending through the registration marker, a known distance defined between the defined plane and the distal tip of the barrel such that, when the lumen receives the bone pin and the distal tip contacts the bone, a location of the entry point is defined along the longitudinal axis at the known distance from the defined plane, as taught by Bonny, in order to facilitate generation of medical records. In the combined invention of Roose, Van der Walt, and Bonny, the distal tip is the distal tip of the barrel.
Regarding claim 25, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21, wherein Roose teaches the registration system further comprising an adjustable fastener (5262) configured to engage the bone pin (5260), wherein the adjustable fastener inhibits movement of the body (5250) relative to the bone pin when the adjustable fastener is engaged (“Additionally, the cutting block 5250 includes a securing device 5262 operable to individually lock each guide pin 5260 in a particular position relative to the cutting block 5250. That is, the guide pins 5260 may be locked in a separate position relative to the cutting block 5250 such that each guide pin 5260 extends downwardly from the bone-facing surface 5254 a selective equal or different distance…The securing device 5262 may use mechanical … devices to lock the guide pins 5260 in the desired position.” [0509]; Fig. 121).
Regarding claim 26, Roose modified by Van der Walt and Bonny teaches the registration system of claim 25, wherein Roose teaches that the body further comprises a threaded through-hole (3264) extending into the body and extending into the guide, wherein the adjustable fastener comprises a threaded fastener (3266) configured to be received within the threaded through-hole so as to extend into the threaded through-hole (“cutting block 3250 also includes a pair of threaded apertures 3264 defined in an end wall of the body 3252. A pair of threaded bolts 3266 are received in the apertures 3264. The threaded bolts 3266 each include a handle 3268 usable to adjust the position of the respective bolt 3266 with respect to the body 3252 of the cutting block 3250. That is, each bolt 3266 may be separately threaded into or out of the block 3250. The threaded apertures 3264 extend through the block such that the ends of the bolts 3266 opposite the handles 268 may contact the bone 3270 of the patient when threaded into the body 3252 a sufficient amount.” [0428]; Fig. 88).
Regarding claim 27, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21, wherein Roose teaches that the body (204) further comprises a tracker coupling (a tracker coupling is required to have the tracker array “rigidly attached”) configured to secure a tracker array (212) thereto (“is rigidly attached to the working portion 142” [0048]), the tracker array configured to be monitored by a tracking device (116) of a navigation system (106) (“A tracking array 212, having three or more fiducial markers, is rigidly attached to the working portion 142 to permit a tracking system 106 to track the POSE of the working portion 204.” [0048]; “two or more optical receivers 116 to detect the position of fiducial markers arranged on rigid bodies.” [0055]; Figs. 1, 2A and 2B).
Regarding claim 28, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21, wherein Roose teaches that a tracker array (212) is integrated into the body (204) (“A tracking array 212, having three or more fiducial markers, is rigidly attached to the working portion 142 to permit a tracking system 106 to track the POSE of the working portion 204.” [0048]; Figs. 1, 2A and 2B), the tracker array configured to be monitored by a tracking device (116) of a navigation system (106) (“two or more optical receivers 116 to detect the position of fiducial markers arranged on rigid bodies.” [0055]; Figs. 1, 2A and 2B. A tracker array being integrated rather than rigidly attached is merely a device improvement with a predictable result of providing less breakable device with tracking capabilities).
Regarding claim 29, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21, wherein Roose teaches the registration system further comprising a navigation system (106), a tracking device (116) and at least one computer (108) (111), the tracking device configured to be tracked by the navigation system (“two or more optical receivers 116 to detect the position of fiducial markers arranged on rigid bodies.” [0055]; Figs. 1, 2A and 2B), the at least one computer in communication with the navigation system and configured to receive positional data (“POSE data” [0056]) associated a position of the registration marker (“the POSE” [0056]) by way of the tracking device being tracked by the navigation system (“The tracking system 106 may be built into a surgical light 118, located on a boom, stand, or built into the walls or ceilings of the operating room. The tracking system computer 111 includes tracking hardware, software, data, and utilities to determine the POSE of objects (e.g. bones such as the femur F and tibia T, the surgical device 104) in a local or global coordinate frame. The POSE of the objects is referred to herein as POSE data, where this POSE data is readily communicated to the device computer 108 through a wired or wireless connection. Alternatively, the device computer 108 may determine the POSE data using the position of the fiducial markers detected directly from the optical receivers 116.” [0056]. “The POSE data is determined using the position of the fiducial markers detected from the optical receivers 116” [0057]; Fig. 1).
Regarding claim 30, Roose modified by Van der Walt and Bonny teaches the registration system of claim 29, wherein Roose teaches that the at least one computer is configured to register the positional data (90) with a computer bone model (92) (94) representative of a patient bone (“Once the reference point 90 is initially established on the most distal point, the reference point 90 is translated to the approximate center of the distal end of the femoral model 94 as illustrated in FIG. 8 such that the Z-axis defining the reference point 90 is parallel to the mechanical axis of the femoral model 92. The anterior-posterior width 96 of the distal end of the femoral model 94 is also determined.” [0269] Figs. 7-9).
Regarding claim 31, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21, wherein Roose teaches that the guide is a through-hole (5258) extending through the body (“A number of guide pin holes 5258 are define in the body 5252 of the block 5250. A guide pin 5260 is received in each guide pin hole 5258 and configured to slide through the corresponding hole 5258 such that the guide pin 5260 is independently movable and positionable in any one of a number of positions relative to the body 5252. That is, each of the guide pins 5260 may be positioned such that a portion of the guide pin extends downwardly from the bone-facing surface 5254” [0507]; Figs. 120-122). In the combined invention of Roose modified by Van der Walt, the through-hole being coaxial with the lumen of the barrel.
Regarding claim 32, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21, wherein Roose teaches the registration system further comprising the bone pin (5210) (5260) (“each of the guide pins 5260 may be positioned such that a portion of the guide pin extends downwardly from the bone-facing surface 5254” [0507]; Figs. 120-122).
Regarding claim 34, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21, wherein Roose teaches that the guide is a first through-hole (5258), the body further comprising a second through-hole (5258) and a third through-hole (5258), the second through-hole configured to receive a second bone pin (5260) there through, the third through-hole configured to receive a third bone pin (5260) there through (“A number of guide pin holes 5258 are define in the body 5252 of the block 5250. A guide pin 5260 is received in each guide pin hole 5258 and configured to slide through the corresponding hole 5258 such that the guide pin 5260 is independently movable and positionable in any one of a number of positions relative to the body 5252. That is, each of the guide pins 5260 may be positioned such that a portion of the guide pin extends downwardly from the bone-facing surface 5254” [0507]; Figs. 121-122).
Claims 22-24 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Roose, Van der Walt, and Bonny as applied to claim 21, and further in view of Cosman et al (US 6259943), hereinafter Cosman.
Regarding claim 22, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21.
Roose as modified by Van der Walt and Bonny does not teach that the registration marker is configured to receive a tip of a registration probe during registration to register a position of the registration marker.
However, in the surgical registration systems field of endeavor, Cosman discloses a frameless to frame-based registration system, which is analogous art. Cosman teaches that the registration marker (“These reference markers could be, for example, divot points, or ball indents” Col. 3, l. 10-37) is configured to receive a tip of a registration probe (“registration means or referencing means” Col. 3, l. 10-37) during registration to register a position of the registration marker (“In FIG. 3, one sees a head ring 301 which is similarly attached by head posts 303 to the patient's anatomy 302 via head screws 304. The ring has reference points or reference markers 308, 309, 310, and 311 as illustrations of a placement of reference points associated with this external apparatus or head clamp. These reference markers could be, for example, divot points, or ball indents, or other physical or mechanically defined reference points that can be touched or registered to by registration means or referencing means once the head clamp has been placed on the patient's head.” Col. 3, l. 10-37).
Therefore, based on Cosman’s teachings, 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 the combined invention of Roose, Van der Walt, and Bonny to have the registration marker that is configured to receive a tip of a registration probe during registration to register a position of the registration marker, as taught by Cosman, in order to improve marker registration by ensuring that the marker is registered by direct contact rather than only remotely by optical detectors.
Regarding claim 23, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21.
Roose as modified by Van der Walt and Bonny does not teach that the registration marker comprises an indent on the body.
However, in the surgical registration systems field of endeavor, Cosman discloses a frameless to frame-based registration system, which is analogous art. Cosman teaches that the registration marker comprises an indent on the body (“These reference markers could be … ball indents” Col. 3, l. 10-37).
Therefore, based on Cosman’s teachings, 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 the combined invention of Roose, Van der Walt, and Bonny to have the registration marker that comprises an indent on the body, as taught by Cosman, in order to improve marker registration by ensuring that the marker is registered by direct contact rather than only remotely by optical detectors.
Regarding claim 24, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21.
Roose as modified by Van der Walt and Bonny does not teach a registration probe configured to register a position of the registration marker.
However, in the surgical registration systems field of endeavor, Cosman discloses a frameless to frame-based registration system, which is analogous art. Cosman teaches a registration probe (“registration means or referencing means” Col. 3, l. 10-37) configured to register a position of the registration marker (“The ring has reference points or reference markers 308, 309, 310, and 311 as illustrations of a placement of reference points associated with this external apparatus or head clamp. These reference markers could be, for example, divot points, or ball indents, or other physical or mechanically defined reference points that can be touched or registered to by registration means or referencing means once the head clamp has been placed on the patient's head.” Col. 3, l. 10-37; Fig. 3).
Therefore, based on Cosman’s teachings, 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 the combined invention of Roose, Van der Walt, and Bonny to have a registration probe configured to register a position of the registration marker, as taught by Cosman, in order to improve marker registration by ensuring that the marker is registered by direct contact rather than only remotely by optical detectors.
Regarding claim 33, Roose modified by Van der Walt and Bonny teaches the registration system of claim 21.
Roose as modified by Van der Walt and Bonny does not teach that the registration marker is a first registration marker, the body further comprising a second registration marker and a third registration marker, the first, second, and third registration markers each configured to receive a tip of a navigated probe during registration, the first, second, and third registration markers defining the defined plane
However, in the surgical registration systems field of endeavor, Cosman discloses a frameless to frame-based registration system, which is analogous art. Cosman teaches that the registration marker is a first registration marker (309) (one of “These reference markers … ball indents” Col. 3, l. 10-37), the body further comprising a second registration marker (310) and a third registration marker (311), the first, second, and third registration markers each configured to receive a tip of a navigated probe during registration, the first, second, and third registration markers defining the defined plane (YcZc plane in Figs. 1 and 3), each registration marker (each of “These reference markers … ball indents” Col. 3, l. 10-37) configured to receive a tip of a navigated probe (“registration means or referencing means” Col. 3, l. 10-37) during registration (“In FIG. 3, one sees a head ring 301 which is similarly attached by head posts 303 to the patient's anatomy 302 via head screws 304. The ring has reference points or reference markers 308, 309, 310, and 311 as illustrations of a placement of reference points associated with this external apparatus or head clamp. These reference markers could be, for example, divot points, or ball indents, or other physical or mechanically defined reference points that can be touched or registered to by registration means or referencing means once the head clamp has been placed on the patient's head.” Col. 3, l. 10-37).
Therefore, based on Cosman’s teachings, 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 the combined invention of Roose, Van der Walt, and Bonny to have the registration marker that is a first registration marker, the body further comprising a second registration marker and a third registration marker, the first, second, and third registration markers each configured to receive a tip of a navigated probe during registration, the first, second, and third registration markers defining the defined plane, as taught by Cosman, in order to improve marker registration by ensuring that the marker is registered by direct contact rather than only remotely by optical detectors.
Claims 35-36, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over van der Walt et al (US 20160242934), hereinafter Van der Walt, in view of Cosman et al (US 6259943), hereinafter Cosman.
Regarding claim 35, Van der Walt teaches a method of surgical registration (“A registration jig” Abstract; “a navigated hip joint implant procedure” [0082]; Figs. 1-3) comprising:
receiving a bone pin (132) into a lumen of a barrel (124) that defines a longitudinal axis (the axis of the cannula 124 seen in Figs. 1 and 3), the barrel extending from a body (136) to a distal tip (near 128), the bone pin extending from a bone of a patient (“the ilium” [0089]; Fig. 2) such that the bone pin defines an entry point (“at an anatomical location or landmark” [0080]. “The landmark “H” is located on the ilium”; [0085]; Fig. 2) at which the bone pin extends into the bone (“The registration jig 104 includes a fixation cannula 124 that has a distal end that can be advanced to a pelvic bone at an anatomical location or landmark…the cannula 124 is secured by a pin 132 (see FIG. 3) that is driven into the ilium on the pelvis through the cannula 124. A distal end 128 of the pin 132 is shown in FIG. 1.” [0080]; “The platform 136 comprises a rigid bar fixed to the proximal end of the pin 132 and/or the cannula 124” [0086]; Figs. 1-3);
contacting the distal tip of the barrel to the bone such that the distal tip is located approximately at the entry point (“the cannula 124 is secured by a pin 132 (see FIG. 3) that is driven into the ilium on the pelvis through the cannula 124.” [0080]; seen in Figs. 1 and 3).
Van der Walt does not teach contacting a registration marker defined on the body with a registration probe in a registration procedure, the longitudinal axis being normal to a defined plane extending through the registration marker, a known distance defined between the defined plane and the distal tip of the barrel; and
determining a location of the entry point from the defined plane and the known distance.
However, in the surgical registration systems field of endeavor, Cosman discloses a frameless to frame-based registration system, which is analogous art. Cosman teaches contacting a registration marker (309-310) (“These reference markers could be, for example, divot points, or ball indents” Col. 3, l. 10-37) defined on the body (301) with a registration probe (“registration means or referencing means” Col. 3, l. 10-37) in a registration procedure (“The ring has reference points or reference markers 308, 309, 310, and 311 as illustrations of a placement of reference points associated with this external apparatus or head clamp. These reference markers could be, for example, divot points, or ball indents, or other physical or mechanically defined reference points that can be touched or registered to by registration means or referencing means once the head clamp has been placed on the patient's head.” Col. 3, l. 10-37), the longitudinal axis (an axis of screw 3 in Fig. 1) being normal to a defined plane (YsZs) extending through the registration marker (309-310), a known distance defined between the defined plane and the distal tip ( a distal tip of 3 in Fig. 1) (a known distance defined by the size of the head clamp or head ring attached to the patient in Figs. 1-3; “In FIG. 1, the head clamp 1, which is an open or substantially C-shaped structure, is attached to the patient's cranium by the screws, such as screw means 3.” Col. 3, l. 65 – Col. 4, l. 22); and
determining a location of the entry point from the defined plane and the known distance (a location of the entry point is determined by the position of the head clamp 1 and direction of screw means 3, corresponding to the defined plane and the known distance in Fig. 1).
Therefore, based on Cosman’s teachings, 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 the invention of Van der Walt to have the steps of contacting a registration marker defined on the body with a registration probe in a registration procedure, the longitudinal axis being normal to a defined plane extending through the registration marker, a known distance defined between the defined plane and the distal tip; and determining a location of the entry point from the defined plane and the known distance, as taught by Cosman, in order to improve marker registration by ensuring that the marker is registered by direct contact rather than only remotely by optical detectors. In the invention of Van der Walt and Cosman, the distal tip is the distal tip of the barrel.
Regarding claim 36, Van der Walt modified by Cosman teaches the method of claim 35, wherein Van der Walt teaches that the entry point is located along the longitudinal axis (the cannula 124 is secured by a pin 132 (see FIG. 3) that is driven into the ilium on the pelvis through the cannula 124. A distal end 128 of the pin 132 is shown in FIG. 1.” [0080]; Figs. 1 and 3).
Regarding claim 38, Van der Walt modified by Cosman teaches the method of claim 35, wherein Van der Walt teaches that the bone is an ilium and the distal tip (610, 612) of the barrel (124) contacts an iliac crest (“the cannula 124 is secured by a pin 132 (see FIG. 3) that is driven into the ilium on the pelvis through the cannula 124. A distal end 128 of the pin 132 is shown in FIG. 1.” [0080] “The system 600, 600B can be attached to the pelvis. The fixation pins 610, 612 can be inserted into the bone. In some techniques, one or more of the fixation pins 610, 612 are positioned over the ASIS on the operative side. In some techniques, one or more of the fixation pins 610, 612 are positioned on the iliac crest. The fixation pins 610, 612 can be approximately vertical. The fixation pins 610, 612 can be inserted by use of a driver.” [0279]; Fig. 18).
Regarding claim 40, Van der Walt modified by Cosman teaches the method of claim 35, wherein Van der Walt teaches contacting one or more points on the bone of the patient with the registration probe (678) (“The probe 678 (not shown) can be bent or curved as described herein. The shape of the probe 678 can facilitate the touching of points or anatomical landmarks in the anterior approach.” [0393]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Van der Walt and Cosman as applied to claim 35, and further in view of Roose et al (US20090093816), hereinafter Roose.
Regarding claim 37, Van der Walt modified by Cosman teaches the method of claim 35.
Van der Walt modified by Cosman does not teach engaging an adjustable fastener to the bone pin such that the adjustable fastener inhibits movement of the body relative to the bone pin.
However, in the surgical instruments field of endeavor, Roose discloses a system and method for fabricating a customized patient-specific surgical instrument, which is analogous art. Roose teaches engaging an adjustable fastener (5262) to the bone pin such that the adjustable fastener inhibits movement of the body relative to the bone pin ([0509] Additionally, the cutting block 5250 includes a securing device 5262 operable to individually lock each guide pin 5260 in a particular position relative to the cutting block 5250. That is, the guide pins 5260 may be locked in a separate position relative to the cutting block 5250 such that each guide pin 5260 extends downwardly from the bone-facing surface 5254 a selective equal or different distance…The securing device 5262 may use mechanical … devices to lock the guide pins 5260 in the desired position.” [0509]; Fig. 121).
Therefore, based on Roose’ teachings, 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 further modified the combined invention of Van der Walt and Cosman to employ the step of engaging an adjustable fastener to the bone pin such that the adjustable fastener inhibits movement of the body relative to the bone pin, as taught by Roose, in order to provide a secure attachment of the device to the bone thereby making the surgery safer for the patient.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Van der Walt and Cosman as applied to claim 35, and further in view of Roose et al (US20090093816), hereinafter Roose.
Regarding claim 39, Van der Walt modified by Cosman teaches the method of claim 35.
Van der Walt modified by Cosman does not teach tracking a tracker array with a tracking device of a navigation system, the tracker array coupled to the body.
However, in the surgical systems field of endeavor, Bonny discloses active robotic pin placement in total knee arthroplasty, which is analogous art. Bonny teaches tracking a tracker array (212) with a tracking device (116) of a navigation system (106) (“two or more optical receivers 116 to detect the position of fiducial markers arranged on rigid bodies.” [0055]; Figs. 1, 2A and 2B), the tracker array coupled to the body (“A tracking array 212, having three or more fiducial markers, is rigidly attached to the working portion 142 to permit a tracking system 106 to track the POSE of the working portion 204.” [0048]; Figs. 1, 2A and 2B).
Therefore, based on Bonny’ teachings, 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 further modified the combined invention of Van der Walt and Cosman to employ tracking a tracker array with a tracking device of a navigation system, the tracker array coupled to the body, as taught by Bonny, in order to facilitate generation of medical records.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXEI BYKHOVSKI whose telephone number is (571)270-1556. The examiner can normally be reached on Monday-Friday: 8:30am - 5:00pm.
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, Pascal Bui Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798