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 .
The Amendment filed 12/1/2025 has been entered. The previous objection to the drawings is withdrawn in light of applicant’s amendments to the specification. The previous objection to the claims is withdrawn in light of applicant’s explanation. Claims 1-20 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to newly amended claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See rejection below.
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 1-17 and 20 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 requires that the joint space is defined superiorly by a first articular surface and inferiorly by a second articular surface. This limitation is interpreted to mean that the first articular surface is referring to the articular surface of the talus and that the second articular surface is referring to the articular surface of the calcaneum. Claim 1 also recites that a first implant component is positioned substantially inferior to the first interfacing surface, which is the prepared first articular surface of the talus, and a second implant component is positioned substantially superior to the second interfacing surface, which is the prepared second articular surface of the calcaneum. Claim 20 then recites that the first implant component is coupled to a calcaneum and the second implant component is coupled to a talus. It is unclear how the first implant can be positioned substantially inferior to the talus and also coupled to the calcaneum, as claimed. Similarly, it is unclear how the second implant can be positioned substantially superior to the calcaneum and also coupled to the talus. For the purpose of further examination, the limitations of claim 20 are interpreted broadly such that the coupling to the calcaneum and to the talus via the first and second implant components, respectively, is indirect.
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.
Claim(s) 1-3, 9-16, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2017/0246004 A1 to Goldberg et al. (Goldberg) in view of US Patent Application Publication No. 2020/0008876 A1 to Nikou et al. (Nikou).
Regarding at least claim 1
Goldberg teaches a subtalar joint implant for replacing a natural subtalar joint existing between the talus and calcaneum bones of a patient (abstract).
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Goldberg meets the limitations of a method for performing an arthroplasty of a subtalar joint (fig. 1), the method comprising: making at least one incision adjacent the subtalar joint (paragraph 0075 discloses cutting a region out of the bone in either or both of the talus and the calcaneum); accessing at least a portion of the subtalar joint (the subtalar joint is accessed in order to perform the replacement of the natural joint as disclosed in paragraph 0051), wherein the subtalar joint comprises a joint space defined superiorly by a first articular surface and inferiorly by a second articular surface (the joint includes a joint space between a first articular surface of a talus bone 102 which provides superiorly a first articular surface and a second articular surface of a calcaneus bone 104 which provides inferiorly a second articular surface); preparing at least one of the first articular surface and the second articular surface to form at least one of a first interfacing surface and a second interfacing surface (paragraph 0075 preparing the joint space between the talus and calcaneum by cutting a region out of either one or both bones which forms at least one of a first and a second interfacing surface); identifying at least one landmark on at least one of the first interfacing surface and the second interfacing surface (paragraph 0077 discloses using a probe to identify a central point/landmark of either or both facets 2 and 6 of the calcaneum and talus, respectively); determining at least one significant point on at least one of the first interfacing surface and the second interfacing surface relative to the at least one landmark (paragraph 0077 discloses using the central point as a reference to make the bony cuts; the location of the bony cuts are construed to be at least one significant point that is determined relative to the central point/landmark); placing at least one trial implant at least partially within the joint space (paragraph 0077 discloses placing a trial implant in situ); selecting an implant (final implant; 20) to correspond to a selected size of the at least one trial implant (paragraph 0077 discloses selecting a relevant final implant using the trial implant as a reference); securing a first implant component (24 or 51; see objection to the claims above with regard to the limitations of dependent claim 20) of the implant substantially inferior relative to the first interfacing surface (of talus 102) and a second implant component (51 or 24; see objection to the claims above with regard to the limitations of dependent claim 20) of the implant substantially superior relative to the second interfacing surface (of calcaneum 104) (fig. 11 shows the implant components positioned as claimed); stabilizing the subtalar joint (paragraph 0078 discloses fixing the implant portions rigidly and reliably to the bones such that the joint is stabilized); and closing the at least one incision (after proper placement of the final implant 20, the incision is closed).
Goldberg also teaches the use of a probe to identify the central point (significant point) of either or both of the middle facets (landmarks; 2 and 6), which is used as a reference to make the bony cuts (paragraph 0077). However, Goldberg does not teach using one or more software programs to analyze the at least one landmark and determine the at least one significant point.
Nikou teaches a system for determining bone laxity during a surgical procedure to replace at least a portion of a bone joint with an implant (paragraph 0007), such as an ankle replacement procedure (paragraph 0051). The system includes a tracked probe (300) configured to provide an indication of at least one anatomical landmark on a bone during the surgical procedure and a computer assisted surgical system (100) that includes a navigation system (130), as well as a processing device/computer system (110), which may include a combination of hardware and software, operably connected to the navigation system, configured to store one or more instructions that, when executed, cause the processing device to receive location information from the navigation system, and generate a surgical plan (abstract and paragraphs 0007, 0045, and 0049-0050).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Goldberg, which includes a probe for identifying a significant point relative to at least one landmark, to include the use of one or more software programs to analyze the at least one landmark and determine the at least one significant point, in order to generate an appropriate surgical plan, as taught by Nikou.
Regarding at least claim 2
Goldberg teaches the method of claim 1. Goldberg also teaches further comprising positioning the at least one trial implant such that at least a portion of the at least one trial implant contacts the first and second interfacing surfaces (paragraph 0077 discloses positioning the trial implant in situ against the cut/interfacing surfaces).
Regarding at least claim 3
Goldberg teaches the method of claim 2, further comprising analyzing a fit of the at least one trial implant within at least a portion of the joint space (paragraph 0077 discloses movement of the hindfoot from side to side a few times to allow the trial implant to settle to the best fit position).
Regarding at least claim 9
Goldberg teaches the method of claim 1. Goldberg further teaches that the method comprises confirming stability of the subtalar joint (paragraph 0012 discloses emulating the stability that is also present in the loaded state in the natural joint).
Regarding at least claim 10
Goldberg teaches the method of claim 1. Goldberg also teaches wherein securing the implant comprises placing at least the first implant component (51) adjacent the first interfacing surface and placing the second implant component (24) adjacent the second interfacing surface, wherein the first implant component is a separate piece from the second implant component (paragraph 0050 discloses attaching the implant, which includes separate first and second implant components, to the calcaneum and talus such that they are adjacent to the first and second interfacing surfaces, as claimed).
Regarding at least claim 11
Goldberg teaches the method of claim 10. Goldberg also teaches further comprising placing a third implant component (52) at least partially within the joint space such that the third implant component is positioned substantially inferior relative to the first implant component and substantially superior relative to the second implant component (fig. 11 shows the positioning of each implant component relative to one another in the same way as applicant’s).
Regarding at least claim 12
Goldberg teaches the method of claim 1. Goldberg also teaches wherein the at least one significant point is at least one center of rotation disposed on the second interfacing surface (paragraph 0060 discloses that the axis of rotation 34 passes through the pivot point 36).
Regarding at least claim 13
Goldberg teaches the method of claim 1. Goldberg also teaches further comprising aligning one or more components of the subtalar joint (paragraph 0018 discloses orienting the surfaces that are made to be aligned in a similar direction to the surfaces of the facet of the subtalar joint, for the purpose of ensuring inversion and eversion can occur through a similar trajectory to that achieved by a healthy, natural subtalar joint).
Regarding at least claim 14
Goldberg teaches the method of claim 13. Goldberg also teaches wherein aligning the subtalar joint comprises manipulating at least one of a talus and a calcaneum such that at least a head of the talus is disposed substantially superior relative to at least a portion of the calcaneum (paragraph 000042 discloses that the talus head articulates with the navicular and its under surface with the calcaneum, such that the head is disposed substantially superior relative to the calcaneum).
Regarding at least claim 15
Goldberg teaches the method of claim 1. Goldberg also teaches wherein the at least one landmark comprises one or more facets substantially disposed on a superior surface of the calcaneum (paragraphs 0076-0077 discloses that the central point/landmark is identified on the middle facet, of the superior surface of the calcaneum).
Regarding at least claim 16
Goldberg teaches the method of claim 1. Goldberg also teaches wherein the first interfacing surface is an inferior surface of the talus and the second interfacing surface is a superior surface of the calcaneum (paragraph 0049 discloses that the bottom/inferior surface of the cut/prepared, interfacing surface of the talus interfaces with the upper/superior surface of the cut/prepared, interfacing surface of the calcaneum, emulating the movement in a natural subtalar joint as claimed).
Regarding at least claim 19
Goldberg meets the limitations of a method for performing arthroplasty of a subtalar joint, the subtalar joint comprising a first surface on a calcaneum (104) and a second surface on a talus (102), the method comprising: identifying at least one landmark of at least one of the first surface and the second surface (paragraph 0077 discloses using a probe to identify a central point/landmark of either or both facets 2 and 6 of the calcaneum and talus, respectively); determining at least one significant point in relation to the at least one landmark (paragraph 0077 discloses using the central point as a reference to make the bony cuts; the location of the bony cuts are construed to be at least one significant point that is determined relative to the central point/landmark); and securing a subtalar implant between the first and second surfaces in a first position (abstract), wherein the subtalar implant comprises a first implant component (51) and a second implant component (24), wherein the first implant component and the second implant component are separate pieces (figs. 9 and 10 show that the components are separate pieces), wherein the first implant component is coupled to the first surface (of talus 102) and the second implant component is coupled to the second surface (of calcaneum 104), and wherein the first position is based on a position of the at least one significant point (the implant position is based on the location of the bony cuts as disclosed in paragraph 0077).
Goldberg also teaches the use of a probe to identify the central point (significant point) of either or both of the middle facets (landmarks; 2 and 6), which is used as a reference to make the bony cuts (paragraph 0077). However, Goldberg does not teach using one or more software programs to analyze the at least one landmark and determine the at least one significant point.
Nikou teaches a system for determining bone laxity during a surgical procedure to replace at least a portion of a bone joint with an implant (paragraph 0007), such as an ankle replacement procedure (paragraph 0051). The system includes a tracked probe (300) configured to provide an indication of at least one anatomical landmark on a bone during the surgical procedure and a computer assisted surgical system (100) that includes a navigation system (130), as well as a processing device/computer system (110), which may include a combination of hardware and software, operably connected to the navigation system, configured to store one or more instructions that, when executed, cause the processing device to receive location information from the navigation system, and generate a surgical plan (abstract and paragraphs 0007, 0045, and 0049-0050).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Goldberg, which includes a probe for identifying a significant point relative to at least one landmark, to include the use of one or more software programs to analyze the at least one landmark and determine the at least one significant point, in order to generate an appropriate surgical plan, as taught by Nikou.
Regarding at least claim 20
Goldberg teaches the method of claim 1. Goldberg also teaches wherein the first implant component (24) is coupled to a calcaneum (104) (paragraph 0078) and wherein the second implant component (51) is coupled to a talus (102) (paragraph 0080). In another interpretation, the first implant component (51) is construed to be indirectly coupled to a calcaneum (104) and wherein the second implant component (24) is construed to be at least indirectly coupled to a talus (102) (see objection to the claims above).
Claim(s) 4-7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg in view of Nikou, as applied to claims 1 and 2, and further in view of US Patent Application Publication No. 2017/0360577 A1 to Dacosta et al. (Dacosta).
Regarding at least claim 4
Goldberg in view of Nikou teaches the method of claim 2. Goldberg also teaches including inserting at least one trial implant. However, Goldberg does not teach placing a first trial implant of the at least one trial implant at least partially within the joint space; and placing a second trial implant at least partially within the joint space, wherein the first trial implant comprise a first size and the second trial implant comprises a second size, wherein the second size is different from the first size.
Dacosta teaches a method for performing a distraction arthrodesis including inserting at least one trial insert for the correction of the joint (abstract).
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Dacosta includes placing at least one trial implant at least partially within the joint space comprises: placing a first trial implant (one of 100, 130, 140, and 150) of the at least one trial implant at least partially within the joint space; and placing a second trial implant (another of 100, 130, 140, and 150) at least partially within the joint space (paragraph 0050 discloses insertion of a second trial within the joint space), wherein the first trial implant comprise a first size and the second trial implant comprises a second size, wherein the second size is different from the first size (it can be seen from fig. 6 that each trial has a different size), for the purpose of determining the correct distraction height to allow for the desired correction in the sagittal plane (paragraph 0049).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Goldberg to include placing a first trial implant of the at least one trial implant at least partially within the joint space; and placing a second trial implant at least partially within the joint space, wherein the first trial implant comprise a first size and the second trial implant comprises a second size, wherein the second size is different from the first size, in order to determine the correct distraction height to allow for the desired correction in the sagittal plane, as taught by Dacosta.
Regarding at least claim 5
Goldberg in view of Nikou teaches the method of claim 1. Goldberg also teaches placing the implant within at least a portion of the joint space (paragraph 0001). However, Goldberg does not teach further comprising analyzing a first position and a first function of the implant after the implant has been placed within at least a portion of the joint space.
Dacosta teaches a method for performing a distraction arthrodesis including inserting at least one trial insert for the correction of the joint (abstract). Dacosta also teaches further comprising analyzing a first position and a first function of the implant after the implant has been placed within at least a portion of the joint space, for the purpose of confirming the reduction of the bones after the implant is fully inserted (paragraph 0052 discloses confirming reduction of the bones using fluoroscopy after the implant is inserted, which meets the limitation of analyzing a first position and a first function of the implant as claimed).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Goldberg to include analyzing a first position and a first function of the implant after the implant has been placed within at least a portion of the joint space, in order to confirm the reduction of the bones after the implant is fully inserted, as taught by Dacosta.
Regarding at least claim 6
Goldberg in view of Nikou and Dacosta teaches the method of claim 5. Dacosta also teaches further comprising confirming the first position and first function of the implant, for the purpose of confirming the reduction of the bones after the implant is fully inserted (paragraph 0052 discloses confirming reduction of the bones using fluoroscopy after the implant is inserted, which meets the limitation of confirming the first position and first function of the implant).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Goldberg in view of Nikou and Dacosta to include confirming the first position and first function of the implant, for the purpose of confirming the reduction of the bones after the implant is fully inserted, in order to confirm the reduction of the bones after the implant is fully inserted, as taught by Dacosta.
Regarding at least claim 7
Goldberg in view of Nikou and Dacosta teaches the method of claim 5. Dacosta also teaches performing a reduction of the subtalar joint after insertion of the implant (paragraph 0052) and that permanent fixation of the implant is not performed until reduction of the joint is confirmed (paragraph 0053). However, Dacosta does not explicitly teach further comprising adjusting the implant within at least a portion of the joint space such that the implant comprises a second position and a second function, wherein the second position and function are different than the first position and function.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Dacosta to include adjusting the implant within at least a portion of the joint space such that the implant comprises a second position and a second function, wherein the second position and function are different than the first position and function, for example, if the reduction of the bones with the implant fully inserted does not achieve the desired results, as implicitly taught by Dacosta, particularly since it is clear from Dacosta that permanent fixation is not performed until reduction of the joint is confirmed.
Regarding at least claim 17
Goldberg in view of Nikou teaches the method of claim 1. Goldberg also teaches performing an arthroplasty of a subtalar joint, as explained above. However, Goldberg does not teach further comprising manipulating one or more soft tissue structures.
Dacosta teaches a method for performing a distraction arthrodesis including inserting at least one trial insert for the correction of the joint (abstract). Dacosta also teaches manipulating one or more soft tissue structures, for the purpose of retracting the soft tissues away from the surgical site (paragraph 0046 discloses releasing the calcaneofibular ligament and mobilizing the peroneal tendons to retract them away from the surgical site).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Goldberg to include manipulating one or more soft tissue structures, for the purpose of retracting the soft tissues away from the surgical site, in order to retract them away from the surgical site, as taught by Dacosta.
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg in view of Nikou, as applied to claim 1, and further in view of US Patent No. 7,625,409 B2 to Saltzman et al. (Saltzman).
Regarding at least claim 8
Goldberg in view of Nikou teaches the method of claim 1. Goldberg also acknowledges that short and stout interosseus talocalcaneal ligaments provide stability to the subtalar joint, as well as a semi-controlled axis of motion for the joint (paragraph 0045). However, Goldberg does not teach wherein stabilizing the subtalar joint comprises manipulating one or more soft tissue structures adjacent to the implant after the implant has been placed and fixated at least partially within the joint space to reach a first stability.
Saltzman teaches an ankle prosthesis including tibial and talar components whose articulating surfaces directly contact one another (abstract). Saltzman also teaches placing trial components, determining ligament laxity/tightness, and performing ligament balancing to help insure proper ligament tension both medially and laterally without excessive laxity or tightness in the ligaments (col. 9, lines 56-61).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Goldberg to include stabilizing the subtalar joint comprises manipulating one or more soft tissue structures adjacent to the implant after the implant has been placed and fixated at least partially within the joint space to reach a first stability, in order to help insure proper ligament tension both medially and laterally without excessive laxity or tightness in the ligaments, as taught by Saltzman.
Regarding at least claim 18
Goldberg meets the limitations of a method for performing arthroplasty of a subtalar joint (abstract), the method comprising: accessing at least a portion of the subtalar joint (paragraph 0075 discloses preparing the subtalar joint space by cutting a region out of one or both bones and therefore requires access to at least a portion of the subtalar joint as claimed); identifying at least one landmark on at least one of an inferior surface of a talus and a superior surface of a calcaneum (paragraph 0077 discloses using a probe to identify a central point/landmark of either or both facets 2 and 6 of the calcaneum and talus, respectively); determining at least one center of rotation disposed on at least one of the inferior and superior surfaces (paragraph 0059 discloses configuring the first surfaces 31 and 41 such that the sliding of the surfaces relative to each other constitutes rotation about an axis that is fixed such that this rotation imitates rotation that is provided by the combination of the posterior facets 1 and 5 of the calcaneum and talus in the natural subtalar joint); placing at least one trial implant adjacent the inferior and superior surfaces (paragraph 007 discloses placement of a trial implant as claimed); securing a subtalar implant (final implant; 20) such that the subtalar implant is positioned substantially between the inferior and superior surfaces (paragraph 0078 discloses positioning of the implant between the inferior/talar surface and superior/calcaneum surfaces), wherein the subtalar implant (20) comprises at least a calcaneum implant (24) and a talus implant (22).
Goldberg also teaches the use of a probe to identify the central point (significant point) of either or both of the middle facets (landmarks; 2 and 6), which is used as a reference to make the bony cuts (paragraph 0077). However, Goldberg does not teach using one or more software programs to analyze the at least one landmark and determine the at least one significant point.
Nikou teaches a system for determining bone laxity during a surgical procedure to replace at least a portion of a bone joint with an implant (paragraph 0007), such as an ankle replacement procedure (paragraph 0051). The system includes a tracked probe (300) configured to provide an indication of at least one anatomical landmark on a bone during the surgical procedure and a computer assisted surgical system (100) that includes a navigation system (130), as well as a processing device/computer system (110), which may include a combination of hardware and software, operably connected to the navigation system, configured to store one or more instructions that, when executed, cause the processing device to receive location information from the navigation system, and generate a surgical plan (abstract and paragraphs 0007, 0045, and 0049-0050).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Goldberg, which includes a probe for identifying a significant point relative to at least one landmark, to include the use of one or more software programs to analyze the at least one landmark and determine the at least one significant point, in order to generate an appropriate surgical plan, as taught by Nikou.
Goldberg further teaches that short and stout interosseus talocalcaneal ligaments provide stability to the subtalar joint, as well as a semi-controlled axis of motion for the joint (paragraph 0045). However, Goldberg does not teach stabilizing the subtalar joint comprising manipulating one or more soft tissue structures adjacent to the implant after the implant has been placed and fixated at least partially within a joint space to reach a first stability.
Saltzman teaches an ankle prosthesis including tibial and talar components whose articulating surfaces directly contact one another (abstract). Saltzman also teaches placing trial components, determining ligament laxity/tightness, and performing ligament balancing to help insure proper ligament tension both medially and laterally without excessive laxity or tightness in the ligaments (col. 9, lines 56-61).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Goldberg to include stabilizing the subtalar joint comprises manipulating one or more soft tissue structures adjacent to the implant after the implant has been placed and fixated at least partially within a joint space to reach a first stability, in order to help insure proper ligament tension both medially and laterally without excessive laxity or tightness in the ligaments, as taught by Saltzman.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/ Examiner, Art Unit 3774
/MELANIE R TYSON/ Supervisory Patent Examiner, Art Unit 3774