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 .
Election/Restrictions
Applicant’s election of Group I, directed to claims 1-18, in the reply filed on 02/02/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 19 and 20 were withdrawn from further consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/09/2024 and 09/17/2025 were considered by the examiner.
Claim Objections
Claims 1-18 objected to because of the following informalities:
Claim 1, line 4: “palpitating” should be replaced with –palpating–;
Claims 2-18: the recitations of “Claim” in the preamble should be in lowercase;
Claim 3, line 3: all instances of “axes” should be replaced with –axis–;
Claim 4, line 2: “axes” should be replaced with –axis–;
Claim 4, line 3: “inferior superior axes” should be replaced with –inferior-superior axis–;
Claim 5, line 4: all instances of “axes” should be replaced with –axis–;
Claim 6, lines 1-2: “a set of locations on a surface of a pelvic bone of a patient” should be replaced with –the set of locations on the surface of the pelvic bone of the patient–;
Claim 10, line 3: “palpitates” should be replaced with –palpates–;
Claim 10, line 6: “palpitates” should be replaced with –palpates–; and
Claim 17, line 3: –the– should be inserted before “determined center”.
Appropriate correction is required.
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 system in claim 1 because it uses a generic placeholder (“system”) that is coupled with functional language (“tracking”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The limitation is being interpreted to correspond to a camera tracking system which includes tracking cameras, as described in ¶ [0044] of the published application, and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the determined APP or FPP” in lines 10-11. There is insufficient antecedent basis for this limitation in the claim. Although claim 1 recites “determine an orientation of an anterior pelvic plane (APP) and/or a functional pelvic plane (FPP)” in lines 7-8, there is no indication that the APP and/or FPP themselves are determined. For the purposes of examination, the recitation in lines 10-11 will be interpreted to be “the determined orientation of the APP and/or FPP”.
Claims 2-18 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “the computer platform records locations” in lines 1-2, which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). The recitation will be interpreted to be “the computer platform is further operative to record locations”. Claims 4, 11, and 15 also recite method steps, so the claims are rejected on similar grounds.
Claim 4 recites “the pose” in line 2. There is insufficient antecedent basis for this limitation in the claim because the claim does not previously recite a “pose”. For the purposes of examination, the recitation will be interpreted to be “a pose”. Claim 5 recites the same limitation in line 3, so it is rejected on the same grounds.
Claim 9 recites “computed assisted navigation during surgery” in line 3. Claim 1 recites “computer assisted navigation during surgery” in line 1. It is unclear if these recitations are the same as, related to, or different from each other. If they are the same, consistent terminology should be used. If they are different, the relationship should be made clear (e.g., using clear modifiers like “first” and “second”). For the purposes of examination, the recitation in claim 9 will be interpreted to be “the computer assisted navigation during the surgery”. Claim 17 recites the same limitation in line 2, so it rejected on the same grounds.
Claim 13, line 5: “the ball” in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the recitation will be interpreted to be “a ball”.
Claim 17 recites “the determined orientation of the APP, determined orientation of the FPP” in line 3, which requires the determination of the orientation of the APP and the FPP. Claim 1 indicates “determine an orientation of an anterior pelvic plane (APP) and/or a functional pelvic plane (FPP)” in lines 7-8, which indicates that there is a scenario when the orientation of only one of the APP and FPP is determined. Therefore, it is unclear whether the orientations of both APP and FPP or only one are required. For the purposes of examination, the recitation of claim 17 will be interpreted to be “the determined orientation of the APP and/or the FPP”
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.
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-3, 5-9, 11-15, and 17-18 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019), and the 2024 Guidance Update on Patent Subject Matter Eligibility (Federal Register, Vol. 89, No. 137 p. 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is directed to a system, which is a statutory category.
Step 2A - Prong 1: Claim 1 is directed to an abstract idea in the form of a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components.
In particular, claim 1 recites the following limitations:
[A1]: identify a set of locations on a surface of a pelvic bone of a patient at which a navigated instrument is palpating while the navigated instrument is being tracked by a tracking system;
[B1]: determine a center of rotation for a pelvic acetabulum of the patient based on the identified set of locations;
[C1]: determine an orientation of an anterior pelvic plane (APP) and/or a functional pelvic plane (FPP) of the patient”.
These elements [A1]-[C1] of claim 1 are directed to an abstract idea because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being mentally performed with the aid of pen and paper. For example, a skilled artisan is capable of mentally determining locations of a navigated instrument in relation to a pelvic bone, estimating a center of rotation of an acetabulum based on the locations, and estimating an orientation of the APP and FPP based on the locations.
Step 2A - Prong Two: Claim 1 does not recite additional elements that integrate the judicial exception into a practical application. Claim 1 recites the following additional elements:
[A2]: a computer platform operative to…;
[B2]: using the navigated instrument while the tracking system is tracking the navigated instrument.
The elements [A2] and [B2] do not integrate the exception into a practical application of the exception.
The element [A2] does not integrate the exception into a practical application of the exception because the element amounts to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - See MPEP 2106.04(d) and MPEP 2106.05(f).
The element [B2] does not integrate the exception into a practical application of the exception because the element amounts to adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea – See MPEP 2106.04(d) and MPEP 2106.05(g).
Accordingly, each of the additional elements do not integrate the abstract into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Claim 1 recites the following additional elements:
[A2]: a computer platform operative to…;
[B2]: using the navigated instrument while the tracking system is tracking the navigated instrument.
The elements [A2] and [B2] do not amount to significantly more than the judicial exception itself.
The element [A2] does not qualify as significantly more because the element is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (See MPEP 2106.05(d)(II); Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (See MPEP 2106.05(d)(II); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93).
The element [B2] amounts to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional, as evidenced by US 2017/0327371 (Bai) in ¶ [0061] which discloses that conventional approaches to continuous tracking of medical tools place tracking markers such as reflective tracking spheres on the medical tool and/or the port tracking tool so that the medical tool and/or the port tracking tool may be tracked by a tracking camera.
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-18 depend from claim 1, and they recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process) and/or append abstract ideas (that is, the claims only recite limitations that add further mental processes) except for the following limitations.
Claim 2 recites “the computer platform records locations… based on tracking of the navigated instrument by the tracking system”. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer - see MPEP 2106.04(d); MPEP 2106.05(f); and/or the element amount to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g). Specifically, a skilled artisan is capable of memorizing locations of the positions output by a navigating system, and the computer platform is merely a tool for implementing the mental process. The tracking of the navigated instrument by the tracking system amounts to mere data gathering. Additionally, a computer platform for recording positions is well-understood, routine, and conventional, as evidenced by US 2011/0313424 A1 (Bono) in ¶ [0057]. Tracking of a navigated instrument by a tracking system is well-understood, routine, and conventional, as evidenced by US 2017/0327371 (Bai) in ¶ [0061]. Claims 3-8 recite similar elements that do not integrate the exception into a practical application of the exception or qualify as significantly more for similar reasons.
Claim 9 recites “display a graphical representation of the determined orientation of the APP and/or the FPP in a planning view for computer assisted navigation during surgery”. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amounts to adding insignificant extra-solution activity to the judicial exception – See MPEP 2106.04(d); MPEP 2106.05(g). Additionally, displaying a graphical representation is well-understood, routine, and conventional, as evidenced by US 2010/0127879 A1 (Hotokebuchi) in ¶ [0054] which indicates that a conventional image display may be used to provide information indicative of a proper inclination of the pelvis.
Claim 12 recites the navigated instrument comprises a ball tip stylus. However, the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amounts to adding insignificant extra-solution activity to the judicial exception – see MPEP 2106.04(d); MPEP 2106.05(g); and/or the element amounts to generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.04(d); MPEP 2106.05(h). Additionally, the element is well-understood, routine, and conventional as evidenced by US 5,806,200 A (Brenner) in col. 5, lines 1-9, which discloses a conventional spherical probe.
Claim 13 recites “identifying locations of fiducials of the ball tip stylus in images being obtained from cameras of the tracking system”. However, the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amounts to adding insignificant extra-solution activity to the judicial exception – see MPEP 2106.04(d); MPEP 2106.05(g); and/or the element amounts to generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.04(d); MPEP 2106.05(h). Additionally, the element is well-understood, routine, and conventional as evidenced by US 2021/0401510 A1 (Theodore) in ¶ [0046] and Fig. 4C, which discloses a conventional digitizing probe includes tracking markers 8 in a known relationship to the probe’s tip, and US 2017/0327371 (Bai) in ¶ [0061], which discloses that conventional approaches to continuous tracking of medical tools use a tracking camera, which necessarily takes images of the probe.
Claim 18 recites “an inbuilt inertial measurement unit (IMU) of the tracking system”. The element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amount to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional as evidenced by US 2022/0065661 A1 (Barak) in ¶ [0071], which discloses a gravity vector can be extracted using well-known methods and using an IMU.
In view of the above, the additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5, 6, 8, 10, 11, and 15-17 are rejected under 35 U.S.C. 102(A1) as being anticipated by WO 2008/017648 A1 (Kammerzell).
With regards to claim 1, Kammerzell teaches a system for computer assisted navigation during surgery (¶ [0023] discloses an apparatus using a surgical navigation system; ¶ [0076] discloses software for providing the functionality of the present invention can be preloaded on the memory of the computer of the navigation system), comprising a computer platform (¶ [0076] discloses the computer of the navigation system having the software for providing the functionality of the present invention) operative to: identify a set of locations on a surface of a pelvic bone of a patient at which a navigated instrument is palpitating while the navigated instrument is being tracked by a tracking system (¶ [0041] discloses anatomical landmarks on the pelvis and recorded relative to the pelvic marker by the navigation system in order to define a pelvic frame of reference with respect to the tracked marker; ¶ [0042] discloses using a pointer; ¶¶ [0003]-[0005] depicts markers mounted on surgical tool/pointer 124 which are monitored of the sensors of the optical surgical navigation system 100; ¶ [0054] discloses some systems ask the surgeon to palpate a plurality of points on the native acetabulum, calculate the sphere that best matches those points, then use the center of that sphere as the center of rotation of the native acetabulum); determine a center of rotation for a pelvic acetabulum of the patient based on the identified set of locations (¶ [0054] discloses calculating a center of rotation of the native acetabulum based on palpated points of the acetabulum); determine an orientation of an anterior pelvic plane (APP) and/or a functional pelvic plane (FPP) of the patient using the navigated instrument while the tracking system is tracking the navigated instrument (¶ [0041] discloses anatomical landmarks on the pelvis and recorded relative to the pelvic marker by the navigation system in order to define a pelvic frame of reference with respect to the tracked marker, wherein the pelvic frame is the anterior pelvic frame); register the pelvis in a coordinate system of the tracking system based on the determined APP or FPP and the determined center of rotation for the pelvic acetabulum (¶ [0043] discloses calculating the position of the anterior pelvic plane in the pelvic frame of reference; ¶ [0055] discloses determination of the center of rotation of the acetabulum in the pelvic frame; also see Fig. 4 and ¶¶ [0059]-[0062] which depicts the coordinate system of the tracking system. The Examiner notes that the calculation of the positions of the anterior pelvic plane and the center of rotation of the acetabulum relative to the pelvic frame of reference amounts to the claimed registering of the pelvis in a coordinate system).
With regards to claim 2, Kammerzell teaches to determine the orientation of the APP, the computer platform records locations of the right anterior superior iliac spine, left anterior superior iliac spine, and pubic symphysis of the pelvic bone of the patient based on tracking of the navigated instrument by the tracking system (Figs. 2, 4 and ¶ [0041] depict the anterior pelvic plane being determined by palpating the left and right iliac spine and anterior superior points 204, 206, and the symphysis pubis 208, and calculating the plane defined by those three points).
With regards to claim 5, Kammerzell teaches, to determine the orientation of the APP, the computer platform is further operative to: record the pose of the navigated instrument (¶ [0003] depicts detecting the positions and orientations of the various tools bearing the markers during the surgery) when the navigated instrument is identifying an inferior-superior axes, a left-right axes, and/or an antero-posterior axes of the pelvic bone of the patient (Fig. 2 and ¶¶ [0043]-[0044] depict determination of an axis running in cranial caudal direction 210 (inferior-superior axis), a line 201 between the left and right superior points which runs along a sagittal direction 211 (left-right axis), and a sagittal plane 222 comprising the cranial caudal direction 210 and an antero-posterior axis 212) .
With regards to claim 6, Kammerzell teaches, when identifying a set of locations on a surface of a pelvic bone of a patient, the computer platform is operative to continuously track a pose of the navigated instrument and a patient dynamic reference base attached to the pelvis (¶ [0003] and Fig. 1 depict detecting the positions and orientations of the various tools bearing the markers during the surgery; ¶¶ [0040], [0043] depict a pelvic marker which establishes a pelvic frame of reference, wherein the pelvic marker amounts toa patient dynamic reference base).
With regards to claim 8, Kammerzell teaches the orientation of the APP and/or the FPP, and the center of rotation for pelvic acetabulum, is determined without the use of pre-operative images (¶¶ [0003], [0041], [0055] teach the determination of the orientation of the APP and the center of rotation without the use of pre-operative images).
With regards to claim 10, Kammerzell teaches the computer platform is further operative to: identify a first location, separate from the set of locations, at which the navigated instrument palpitates a proximal femoral greater trochanter region at least proximate to an exit point of a femoral anatomical axis (¶¶ [0024], [0058]-[0062] discloses palpating a second femoral point which may be a point on the greater trochanter which can be palpated through the femoral cut); identify a second location, separate from the set of locations, at which the navigated instrument palpitates a known location of a distal part of the femur (¶¶ [0023], [0024], [0058]-[0062] discloses a first palpated point being a patella; ¶ [0046] discloses the point is either the epicondyles or a point on the patella, wherein the epicondyles is a known location of a distal part of the femur); and determine a length of a leg of the patient and a medio-lateral femur positioning offset based on the identified first location and identified second location (¶¶ [0023], [0046], [0058]-[0062] and Fig. 4 disclose determining the position and length of a line between the center of rotation of the hip joint and the acquired point on the femur, which is the patella or epicondyles; ¶ [0024], [0058]-[0062] and Fig. 4 depict determining a position and length of a second line perpendicular to the first line and runs from the first line to the second palpated point on the femur (e.g., the trochanter)).
With regards to claim 11, Kammerzell teaches the computer platform identifies the first location after a femur of the patient is placed in a known position to confirm a planned leg length (¶ [0024] discloses the point on the greater trochanter is palpated during a hip replacement surgery; ¶ [0039] discloses the leg should be placed in approximately the same amount of knee flexure for the acquisition phase as well as the implantation phase to maximize accuracy).
With regards to claim 15, Kammerzell teaches the computer platform determines the center of rotation for the pelvic acetabulum after a femoral head of a femur of the patient is removed from the acetabular cavity (¶¶ [0052]-[0054] depict the center of rotation of the native acetabulum and the test cup is determined after the femoral head is removed from the acetabulum).
With regards to claim 16, Kammerzell teaches the computer platform is further operative to: generate a model of the shape of the acetabulum cavity based on the identified set of locations (¶ [0054] discloses calculation of a sphere (which is a model of a shape of the cavity) that matches a plurality of points on the native acetabulum, wherein the center of the sphere is a center of rotation of the acetabulum).
With regards to claim 17, Kammerzell teaches the computer platform is further operative to: register in an algorithm for computer assisted navigation during surgery, at least one of the determined orientation of the APP, determined orientation of the FPP, and determined center of rotation for the pelvic acetabulum (¶ [0076] discloses software for providing the functionality of the present invention; ¶ [0043] discloses calculating the position of the anterior pelvic plane in the pelvic frame of reference; ¶ [0055] discloses determination of the center of rotation of the acetabulum in the pelvic frame; also see Fig. 4 and ¶¶ [0059]-[0062] which depicts the coordinate system of the tracking system. The Examiner notes that the calculation of the positions of the anterior pelvic plane and the center of rotation of the acetabulum relative to the pelvic frame of reference amounts to the claimed registering in the algorithm).
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.
Claims 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/017648 A1 (Kammerzell), as applied to rejection of claim 1 under 35 U.S.C. §102 above, in view of US 2018/0296365 A1 (Nielsen)
With regards to claim 3, Kammerzell teaches that, to determine the orientation of the APP, the computer platform is further operative to: identify an inferior-superior axes, a left-right axes, and/or an antero-posterior axes of the pelvic bone of the patient based on tracking of the navigated instrument by the tracking system (¶ [0003] depicts detecting the positions and orientations of the various tools bearing the markers during the surgery, Fig. 2 and ¶¶ [0043]-[0044] depict determination of an APP using an axis running in cranial caudal direction 210 (inferior-superior axis), a line 201 between the left and right superior points which runs along a sagittal direction 211 (left-right axis), and a sagittal plane 222 comprising the cranial caudal direction 210 and an antero-posterior axis 212).
Kammerzell is silent regarding whether the determination of the orientation of the FPP are based on axes identified in the determination of the APP.
In the same field of endeavor of determining pelvic parameters, Nielsen teaches calculating a functional pelvic plane using an anterior pelvic plane (¶ [0281] depicts an Adjusted Plane (i.e., the functional pelvic plane) is found by rotation of the Anterior Pelvic Plane about the inter-ASIS line to be perpendicular to the force of gravity). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kammerzell to incorporate determination of a functional pelvic plane using an anterior pelvic plane as taught by Nielson, which results in the orientation of the FPP being based on the axes of the pelvis. The motivation would have been to improve alignment of the hip components with a patient’s anatomy during a hip replacement procedure (¶ [0014] of Nielson) and/or to provide a more complete diagnostic analysis of the patient.
With regards to claim 18, Kammerzell is silent regarding whether the computer platform is further operative to determine the orientation of the APP or the FPP based on a gravity vector of an inbuilt inertial measurement unit (IMU) of the tracking system.
In the same field of endeavor of determining pelvic parameters, Nielsen teaches calculating a functional pelvic plane based on a gravity vector of an inbuilt inertial measurement unit (IMU) of the tracking system (¶ [0281] depicts an Adjusted Plane (i.e., the functional pelvic plane) is found by rotation of the Anterior Pelvic Plane about the inter-ASIS line to be perpendicular to the force of gravity, wherein the orientation sensing device 204 includes one or more inertial sensors for providing a vector aligned with vertical or gravity). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kammerzell to incorporate determination of a functional pelvic plane using a gravity vector of an inbuilt inertial measurement unit (IMU) of the tracking system as taught by Nielsen. The motivation would have been to improve alignment of the hip components with a patient’s anatomy during a hip replacement procedure (¶ [0014] of Nielson) and/or to provide a more complete diagnostic analysis of the patient.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/017648 A1 (Kammerzell) in view of US 2018/0296365 A1 (Nielsen), as applied to claim 3 above, and further in view of US 2022/0211416 A1 (Drain)
With regards to claim 4, the above combination is silent regarding whether the computer platform identifies the inferior-superior axes by recording the pose of the navigated instrument when a rod on the navigated instrument is parallel to the inferior superior axes.
In the same field of endeavor of monitoring orientations of the pelvis, Drain teaches a computer platform configured to identify the inferior-superior axes by recording the pose of the navigated instrument when a rod on the navigated instrument is parallel to the inferior superior axes (¶¶ [0129]-[0130] and Figs. 5-8 depict a processor configured to associate a heading of an orientation sensor 30 with a desired axis of the patient, wherein Fig. 8 depicts a rod of the orientation sensor 30 aligned with the X-axis and also being parallel with a longitudinal body axis P). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the inferior-superior axes of the above combination to incorporate that it is performed using the computer platform configured to identify the inferior-superior axes by recording the pose of the navigated instrument when a rod on the navigated instrument is parallel to the inferior superior axes as taught by Drain. The motivation would have been to substitute one known method for determining the inferior-superior axis for another to obtain predictable results.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/017648 A1 (Kammerzell), as applied to rejection of claim 1 under 35 U.S.C. §102 above, in view of US 2012/0209277 A1 (Leparmentier).
With regards to claim 7, the Kammerzell is silent regarding whether the computer platform is further operative to: identify another location at which the navigated instrument is contacting a deepest point on an acetabular fossa; and determine a maximum acetabular reaming depth based on the identified another location.
In the same field of endeavor of computer assisted navigation during surgery, Leparmentier teaches identify another location at which the navigated instrument is contacting a deepest point on an acetabular fossa (¶ [0032] discloses determining a deepest center position 126 of the prosthetic cup in the acetabulum 22); and determine a maximum acetabular reaming depth based on the identified another location (¶ [0032] discloses determining the depth of impaction D based on the deepest center position 126 of the prosthetic cup). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computer platform of Kammerzell to incorporate that it is operative to: identify another location at which the navigated instrument is contacting a deepest point on an acetabular fossa; and determine a maximum acetabular reaming depth based on the identified another location as taught by Leparmentier.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/017648 A1 (Kammerzell), as applied to rejection of claim 1 under 35 U.S.C. §102 above, in view of US 2018/0296365 A1 (Nielsen)
With regards to claim 9, Kammerzell is silent regarding whether the computer platform is further operative to: display a graphical representation of the determined orientation of the APP and/or the FPP in a planning view for computer assisted navigation during surgery.
In the same field of endeavor of determining pelvic parameters, Nielsen teaches displaying a graphical representation of the determined orientation of the APP and/or the FPP in a planning view for computer assisted navigation during surgery (¶¶ [0267], [0291] discloses displaying information with respect to the APP or the adjusted plane including the abduction and anteversion angles in cup placement with respect to the APP or adjusted plane; Fig. 29 and ¶ [0313] depict a graphical display of the abduction and anteversion relative to the reference plane). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computer platform of Kammerzell to incorporate that it is operative to: display a graphical representation of the determined orientation of the APP and/or the FPP in a planning view for computer assisted navigation during surgery as taught by Nielsen. The motivation would have been to effectively communication information for the user to further assist in the surgery.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/017648 A1 (Kammerzell), as applied to rejection of claim 1 under 35 U.S.C. §102 above, in view of US 2015/0230877 A1 (Lavallee)
With regards to claim 12, Kammerzell is silent regarding whether the navigated instrument comprises a ball tip stylus.
In a system relevant to the problem of tracking positions of a device relative to a bone, Lavallee teaches a navigated instrument comprising a ball tip stylus (Figs. 2A-2B and ¶ [0077] depict a sensor 10 including a ball tip stylus, wherein points of the stylus of the sensor 10 can be digitized). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the navigated instrument of Kammerzell with the navigated instrument comprising the ball tip stylus of Lavallee. Because both elements are capable of monitoring positions of a bone surface during a surgery, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 13, the above combination is silent regarding whether the computer platform is operative to identify the set of locations by: identifying locations of fiducials of the ball tip stylus in images being obtained from cameras of the tracking system; determining locations of a center of the ball based on the locations of the fiducials of the ball tip stylus; defining an offset-acquired surface of the bone based on mathematically connecting the locations of the center of the ball; determining local normal vectors to the offset-acquired surface for the locations of the center of the ball; and translating the offset-acquired surface of the bone toward the surface of the bone along the local normal vectors based on a radius of the ball to define an acquired surface of the bone.
In a system relevant to the problem of tracking positions of a device relative to a bone, Lavallee teaches identifying locations of fiducials of the ball tip stylus in images being obtained from cameras of the tracking system (¶ [0073] discloses determining locations of markers using a tridimensional positioning system, wherein a palpation device has a P shape (see sensor 10 of Fig. 2B) and has markers); determining locations of a center of the ball based on the locations of the fiducials of the ball tip stylus (¶ [0076] discloses digitizing points on the bone surface using a palpation device locatable in the tridimensional positioning system; Fig. 2B and ¶ [0077] discloses determination of points shifted by a value equal to the radius of the sphere outside of the real surface based on the markers); defining an offset-acquired surface of the bone based on mathematically connecting the locations of the center of the ball (¶ [0077] discloses progressively minimizing the sum of the distances between each point and the model surface to which the value of the sensor radius is subtracted provided that the distances to the surface are positive outside of the surface and negative inside of the surface); determining local normal vectors to the offset-acquired surface for the locations of the center of the ball (Fig. 2B and ¶ [0077] depict the determination of normal vectors); and translating the offset-acquired surface of the bone toward the surface of the bone along the local normal vectors based on a radius of the ball to define an acquired surface of the bone (Fig. 2B and ¶ [0077] discloses offsetting based on the radius of the sensor sphere). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate the computer platform is operative to identify the set of locations by: identifying locations of fiducials of the ball tip stylus in images being obtained from cameras of the tracking system; determining locations of a center of the ball based on the locations of the fiducials of the ball tip stylus; defining an offset-acquired surface of the bone based on mathematically connecting the locations of the center of the ball; determining local normal vectors to the offset-acquired surface for the locations of the center of the ball; and translating the offset-acquired surface of the bone toward the surface of the bone along the local normal vectors based on a radius of the ball to define an acquired surface of the bone as taught by Lavallee. The motivation would have been to improve the digitization of the bone surface by providing a more accurate determination of the location of the probe tip.
With regards to claim 14, the above combination teaches or suggests the computer platform is operative to identify the set of locations by simultaneously tracking the fiducials of the ball tip stylus and a patient dynamic reference base attached to the pelvis (¶ [0003] and Fig. 1 of Kammerzell depict detecting the positions and orientations of the various tools bearing the markers during the surgery; ¶¶ [0040], [0043] of Kammerzell depict a pelvic marker which establishes a pelvic frame of reference, wherein the pelvic marker amounts toa patient dynamic reference base; the above combination teaches or suggests that the fiducials of the ball tip stylus are determined).
Conclusion
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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