1. Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 11/10/2025 is acknowledged. Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
2. Claims 1, 5, and 16 are objected to because of the following informalities: In claim 1, there is a missing “of” just after “medical imaging” in the third clause. In claim 5, there is a missing “the” in line 2, just before the first instance of “bone tunnel guide.” In claim 16, line 4, there is a missing “side” just after “lateral.”
3. 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 1-4, 6-8, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roose et al. (US 2012/0041445; “Roose” herein).
Regarding claim 1, Roose discloses a bone tunnel guide (e.g. 52) capable of being used to form a bone tunnel in bone of a patient (e.g. through 114). The bone tunnel guide comprises: a body (e.g. 56) having a superior side, an inferior side, a medial side, a lateral side, a posterior side, and an anterior side (e.g. in Fig. 2, the body can be subdivided into superior, inferior, medial, lateral posterior, and anterior sides); a trajectory port (e.g. 114) that extends through the body, the trajectory port configured to guide a tool (e.g. tool 54) for forming a bone tunnel in a bone of a patient, the trajectory port defined at least partially based on a bone model of at least a portion of the bone (e.g. Fig. 1), the bone model based on medical imaging of the bone of the patient (e.g. process steps 18, 26); and a bone engagement feature (e.g. 78) that extends from the body, the bone engagement feature configured to engage (e.g. at 86) at least a portion of the bone such that the bone engagement feature positions the bone tunnel guide in a position that corresponds to a modeled position of a bone tunnel guide model engaging a bone model.
Regarding claim 2, Roose discloses at least one aspect of the bone tunnel guide is configured based at least partially on user directions provided before the bone tunnel guide is fabricated (e.g. a user can issue configuration directions prior to the fabrication process).
Regarding claim 3, Roose discloses the bone engagement feature comprises at least one patient-specific aspect (e.g. 86) unique to the patient.
Regarding claim 4, Roose discloses the patient-specific aspect comprises a bone engagement surface (e.g. 86) on a bone-facing surface of the bone engagement feature, the bone engagement surface configured to engage at least one landmark (e.g. portions of pubis, ischium, coxal bone, etc; para. [0046]) of the bone of the patient.
Regarding claim 6, Roose discloses a plurality of bone engagement features (e.g. 74, 78), each extending away from the trajectory port (e.g. Fig. 4).
Regarding claim 7, Roose discloses a number of bone engagement features of the plurality of bone engagement features is directly proportional to a number of landmark configurations near, or at, the modeled position of the bone tunnel guide model engaging the bone model (e.g. the three bone engagement features in Fig. 4 correspond to three bone contours proximate to an acetabulum; para. [0046]).
Regarding claim 8, Roose discloses a number of bone engagement features of the plurality of bone engagement features is determined at least partially by user directions (e.g. a user can issue a numerical direction corresponding to the number of engagement features shown in Fig. 4).
Regarding claim 13, Roose discloses a landmark registration feature (e.g. 86) configured to engage a landmark of the bone.
Regarding claim 14, Roose discloses a configuration of the bone engagement feature is directly proportional to a landmark configuration of the bone indicated on the bone model (e.g. there are three bone engagement features in Fig. 4 that correspond to three bone contours proximate to an acetabulum; para. [0046]).
Claims 1, 12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Metzger et al. (US 2011/0015639; “Metzger” herein).
Regarding claim 1, Metzger discloses a bone tunnel guide (e.g. 100) for forming a bone tunnel in bone of a patient. The bone tunnel guide comprises: a body (e.g. 131) having a superior side, an inferior side, a medial side, a lateral side, a posterior side, and an anterior side (e.g. in Fig. 55, the body can be subdivided into superior, inferior, medial, lateral posterior, and anterior sides); a trajectory port (e.g. 109) that extends through the body, the trajectory port configured to guide a tool (e.g. a drill bit; para. [0058]) for forming a bone tunnel in a bone of a patient, the trajectory port defined at least partially based on a bone model of at least a portion of the bone, the bone model based on medical imaging of the bone of the patient (e.g. para. [0053], [0070]); and a bone engagement feature (e.g. 130) that extends from the body, the bone engagement feature configured to engage at least a portion of the bone such that the bone engagement feature positions the bone tunnel guide in a position that corresponds to a modeled position of a bone tunnel guide model engaging a bone model.
Regarding claim 12, Metzger discloses a bone engagement surface (e.g. 113) on at least part of the inferior side of the body, the bone engagement surface defined at least partially based on the bone model.
Regarding claim 15, Metzger discloses the bone tunnel guide is fabricated from one of a polymer and metal (e.g. para. [0061]).
4. 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Roose, as above, in view of Romano et al. (US 2011/0106093). Roose discloses the bone engagement surface corresponds to a surface of the bone (e.g. para. [0046]) but is silent regarding the bone tunnel guide providing haptic feedback to a user when the bone tunnel guide translates to the position corresponding to the modeled position of the bone tunnel guide model engaging the bone model. Romano discloses a guide may be configured such that a surgeon can experience tactile feedback by a guide’s fit on bone to ensure proper alignment of the guide (e.g. para. [0049]). It is considered obvious to have applied the teaching of a guide’s fit on bone generating tactile feedback that can be experienced by a surgeon per Romano to the bone engagement surface and the surface of the bone per Roose as such would have facilitated proper positioning of a guide relative to bone.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Roose, as above, in view of Ashman (US 2010/0145351). Roose discloses the bone tunnel guide can be secured in place for formation of a bone tunnel by the trajectory port (e.g. Fig. 3), but fails to disclose a handle configured to perform said securement, the handle having a shaft having a proximal end and a distal end, the distal end comprising a coupler comprising external threads configured to engage internal threads formed in the body. Ashman discloses a drill guide (e.g. 302) wherein a body (e.g. 302) can be manipulated by means of a removable handle (e.g. 304) comprising a shaft (e.g. Fig. 3A) having a threaded end (e.g. 310) that mates with a coupler comprising threads (e.g. 312) in a body. It is considered obvious to have applied the teaching of a removable handle comprising a shaft having a threaded end that mates with coupler comprising threads in a body per Ashman to the body of Roose, as such would have facilitated manipulation of a guide by a surgeon to assist a surgeon in positioning a guide on bone, thereby facilitating accurate placement of the guide on bone.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Metzger, as above, in view of Jensen (2004/0260291). Metzger discloses the trajectory port comprises a port body (e.g. 108) that extends away from the body and comprises a length (e.g. Fig. 3), but is silent regarding the length enabling a user to grasp the port body to secure the bone tunnel guide in place for formation of a bone tunnel by way of the trajectory port. Jensen discloses a guide device can be held in position during its use manually by a portion that is graspable (e.g. para. [0084]). It is considered obvious to have applied the teaching of a guide device capable of being held in position during its use manually by a portion that is graspable to the length and any other aspect of the port body as such would have facilitated manual handling of the guide upon bone so that surgical procedures are performed accurately and without fumbling of the guide.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Perler et al. (US 2021/0077192; “Perler” herein) in view of Sarrett (US 5405354) and Ashman (US 2010/0145351).
Perler discloses a system (e.g. 300) capable of being used for tendon transfer (e.g. a tendon can be placed in the foot during use of the system) for tendon deployment to remediate a bone condition present in a patient's foot (e.g. 200). The system comprises a tendon trajectory guide (e.g. 300) comprising a body (e.g. 310) having a superior side, an inferior side, a medial side, a lateral, a posterior side, and an anterior side (e.g. body can be subdivided into such sides in Fig. 5A); a trajectory port (e.g. 340) that extends through the body, the trajectory port configured to guide a tool (e.g. a pin or k-wire; para. [0067]) in a foot bone of a patient, the trajectory port defined at least partially on a bone model of at least a portion of the foot bone, the bone model based on medical imaging of the foot bone of the patient (e.g. para. [0044]); and a bone engagement surface (e.g. 742) on the inferior side of the body, the bone engagement surface configured to engage a surface of the foot bone such that the bone engagement surface positions the tendon trajectory guide at a desired position on the foot bone.
Perler does not explicitly indicate that the trajectory port can guide a tool for forming a bone tunnel. However, Perler discloses that a guide feature may be used to guide a drill (e.g. para. [0070]). It is considered obvious to have applied the concept of a guide feature being used to guide a drill per Perler to the trajectory port of Perler as such would have facilitated formation of a hole in bone, such as to create a starter/pilot hole for a pin or k-wire, thereby enabling placement of a pin or k-wire without excessive force.
Perler does not disclose an inserter having: a proximal end; a distal end; an elongated body between the proximal end and the distal end; and the distal end comprises a point and the proximal end comprises an opening.
Sarrett discloses a suture driver (e.g. 10) comprising a distal end having a point (e.g. bottom-most tip in Fig. 3), a proximal end having an opening (e.g. 28), and an elongate body between the ends (e.g. Fig. 1); and that said suture driver can be used to manipulate sutures at a surgical site (e.g. col. 1, lines 5-8). It is considered obvious to provided the suture driver per Sarrett to the system of Perler, as such would have enabled a surgeon to manipulate sutures at a surgical site, thereby facilitating performance of a procedure that requires suture handling, such as a closure of an incision.
Perler further fails to disclose a handle comprising a first coupler configured to removably engage with a second coupler connected to the tendon trajectory guide. Ashman discloses a drill guide (e.g. 302) wherein a body (e.g. 302) can be manipulated by means of a removable handle (e.g. 304) comprising a shaft (e.g. Fig. 3A) and a threaded end (e.g. 310) that mates with coupler comprising threads (e.g. 312) in a body. It is considered obvious to have applied the teaching of a removable handle comprising a shaft and a threaded end that mates with coupler comprising threads in a body per Ashman to the body of Roose, as such would have facilitated manipulation of a guide by a surgeon in order ensure accurate placement without fumbling of the guide.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Perler in view of Sarrett and Ashman, as above, and further in view of Metzger. Perler discloses lateral positions on the body (e.g. portions of the top left or bottom right in Fig. 7A) but does not disclose a plurality of appendages that extend from said lateral positions, each appendage having an appendage inferior surface and comprising a bone engagement surface on the appendage inferior surface. Metzger discloses a guide may comprise arms (e.g. 130) that extend from sides of the guide (e.g. Fig. 3) and may include a patient-specific bone engagement surface (e.g. 113; para. [0059], [0064]). It is considered obvious to have applied the teaching of arms extending from sides of a guide and including a patient-specific bone engagement surface per Metzger to the lateral positions of the guide of Perler as such would have increased contact between guide and bone thereby stabilizing the guide on bone to minimize movement of the guide on bone to ensure accuracy of actions performed on the bone with the guide.
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN A. SEVILLA whose telephone number is (571)270-5621. The examiner can normally be reached on Monday through Thursday, 8:00 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. 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.
/CHRISTIAN A SEVILLA/ Primary Examiner, Art Unit 3775