Detailed Action
This is the final office action for US application number 18/535,931. Claims are evaluated as filed on January 8, 2026.
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 .
Response to Arguments
Applicant's arguments filed January 8, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Ricica and Medoff teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that Ricica’s plate 300 is intentionally designed with angle 311 and does not indicate that plate 300 is bendable or that angle 311 can have any variety of angle values within a range (Remarks p. 5), Examiner agrees that Ricica does not expressly state that the plate 300 is bendable or that angle 311 can be any variety of angle values within a range. However, plate 300 would not be able to perform the disclosed function or positioning if it were not capable of bending. Ricica specifically discloses that laminoplasty includes partially cutting a lamina to create a hinge and using a plate or wedge made out of bone, metal, or plastic to hold the spinal canal open (¶32). Ricica further discloses that a plate is also used to support the hinged side of the lamina and hinge plate 300 comprises a second segment 305 that forms an angle 311 with the first segment 301 (¶35). That is, Ricica discloses that the plate is constructed of materials that are well known to be capable of bending, is positioned at a hinge at an angle that is created/determined in situ as the surgical correction progresses, and is shown in at least Fig. 3A have both the lateral and medial sides of the plate substantially contoured to the bone. Thus, it appears unreasonable to assert that the plate can function as disclosed without being capable of bending.
With regards to Applicant’s argument that Ricica does not suggest that the plate 300 remains fixed to both side of the partial cut during any bending of the plate (Remarks p. 6), Examiner agrees. As noted on page 6 of the non-final office action dated September 24, 2025, Ricica is silent as to how and when plate 300 is attached to the bone. Instead, as detailed on page 7 of the non-final office action dated September 24, 2025, it would be obvious to specify attaching the plate prior to distracting the full cut in order to strengthen the pivot on the weakened lamina at the partial cut, e.g. to help ensure that the remaining lamina does not break at the partial cut when such hinges during distraction of the full cut.
With regards to Applicant’s argument that Ricica does not disclose an operative step of forming a bend in the hinge during a surgical procedure (Remarks p. 6), Examiner agrees and notes that it has not been asserted otherwise. Examiner directs Applicant to the rejection below, and in the non-final office action dated September 24, 2025, for a more in-depth description of the limitations. Further, Examiner notes that Applicant has not claimed an operative step of “forming a bend in the hinge during a surgical procedure” as appears to be argued.
With regards to Applicant’s argument that Ricica discloses engaging instrument 165 with only two sides of a full cute as shown in Fig. 5B (Remarks p. 6), Examiner agrees and notes that it has not been asserted otherwise. Examiner directs Applicant to the rejection below, and in the non-final office action dated September 24, 2025, for a more in-depth description of the limitations.
With regards to Applicant’s argument that there is no disclosure in Ricica or Medoff that would engage a plate on the partial cut side and be used to form a bend in a plate on the partial cut side (Remarks p. 6), Examiner notes that no reason has been provided for this assertion. Thus, Examiner directs Applicant to the rejection below, and in the non-final office action dated September 24, 2025, for a more in-depth description of the limitations. Examiner notes that Ricica discloses the plate positioning and instruments and Medoff teaches modifications of the instruments and their usage.
With regards to Applicant’s argument that Medoff’s instrument is used to either perform compression or distraction for fracture fixation in Fig. 9 (Remarks p. 6), Examiner notes that Medoff has not been used to teach modifying the bone movement of the method of Ricica, but, as noted, such are analogous in that they are used for distraction of bone portions. Instead, as detailed below and on p. 7 of the non-final office action dated September 24, 2025, Medoff teaches modifying the primary instrument and the secondary instrument so that the primary instrument engages the plate via a u-shaped wedge underneath a screw head and the secondary instrument has a reversible coupling in order to distract the bone portions by gripping a plate positioned to strengthen a bone pivot location.
With regards to Applicant’s argument that Medoff enables linear compression/distraction via slots along the plate, emphasizes that vector of force should be parallel to the central axis of the plate, and as such, one would not contemplate the intentional bending of Medoff’s plate as such would render it unsuitable for its intended purpose (Remarks p. 7), Examiner notes that such a modification has not been proposed.
With regards to Applicant’s argument that in the method of independent claim 9, the plate is attached with both portions of the lamina as the implant is bent (Remarks p. 7), Examiner notes that review of claim 9 shows that this does not appear to be true. Instead, such provides that “moving the primary instrument of the cervical laminoplasty system relative to the patient to form a bend in the implant plate, the bend disposed between the lateral side of the implant plate and the medial side of the implant plate”.
With regards to Applicant’s argument that Medoff’s instrument is fixed only to one bone portion and must be free of the other bone portion to achieve desired compression/distraction (Remarks p. 7), Examiner notes that Medoff has not been applied as a teaching of any features of the plate as appears to be implied by this argument. Further, Examiner notes that in both Ricica and Medoff the primary and secondary instrument function to distract separated bone portions.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 18 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim(s) 18 recites/recite the limitation "the first instrument of the cervical laminoplasty system" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the step of moving the primary instrument of the cervical laminoplasty system relative to the patient comprises rotating the primary instrument of the cervical laminoplasty system”.
Claim Rejections - 35 USC § 103
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 of this title, 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) 9-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ricica et al. (US 2015/0265317, hereinafter “Ricica”) in view of Medoff et al. (US 2012/0197304, hereinafter “Medoff”).
As to claims 9, 13-15, and 17, Ricica discloses a method (Figs. 3A-3D and 5-6C) of performing a cervical laminoplasty procedure (Figs. 3A-3D, 5-6C, ¶s 3 and 7), the method comprising: creating a partial cut (96, Fig. 5A, ¶37) in a first lamina of a vertebra of a patient (Fig. 5A, ¶37); attaching an implant plate (300) with the vertebra of the patient (Fig. 3A, ¶35), wherein a lateral side of the plate (305) is attached with a lateral portion of the first lamina of the vertebra (Fig. 3A), and wherein a medial side of the plate (301) is attached with a medial portion of the first lamina of the vertebra (Fig. 3A); creating a full cut (93, Fig. 5A, ¶37) in a second lamina of the vertebra of the patient (Fig. 5A, ¶37); engaging a primary instrument (171 of 165, Figs. 5A and 5B) of a cervical laminoplasty system (Figs. 3A-3D and 5-5B) with the vertebra (Figs. 5A-5B); and moving the primary instrument of the cervical laminoplasty system relative to the patient (Figs. 5A-5B), the plate comprising a bend in the implant plate (forming angle 311, Figs. 3A-3D, ¶35), the bend disposed between the lateral side of the implant plate and the medial side of the implant plate (Figs. 3A-3D, ¶35) to accommodate the specific vertebra (Fig. 3A); wherein the cervical laminoplasty system further comprises a secondary instrument (170 of 165, Figs. 5A and 5B) used in distracting the full cut (Fig. 5B); wherein the implant plate strengthens the pivot (¶35). As to claim 13, Ricica discloses that the step of attaching the implant plate with the vertebra of the patient comprises securing the lateral side of the implant plate with the lateral portion of the first lamina using one or more lateral bone screws (fasteners in 308a and 308b as disclosed in ¶35, Fig. 3A, ¶35). As to claim 14, Ricica discloses that the step of attaching the implant plate with the vertebra of the patient comprises securing the medial side of the implant plate with the medial portion of the first lamina using one or more medial bone screws (fasteners in 302a and 302b as disclosed in ¶35, Fig. 3A, ¶35). As to claim 15, Ricica discloses that the implant plate comprises a bridge (central portion shown between 305 and 301 in Fig 3D, Fig. 3D) disposed between the lateral side of the implant plate and the medial side of the implant plate (as defined, Figs. 3A-3D), and the step of forming the bend in the implant plate comprises bending the bridge (to form and at angle 311, Fig. 3C, ¶311). As to claim 17, Ricica and Medoff discloses that the bend has an angle (311, Figs. 3A-3D) with a value within a range from about 1 degree to about 60 degrees (Fig. 3C).
Ricica is silent to engaging the primary instrument of the cervical laminoplasty system with the implant plate, moving the primary instrument of the cervical laminoplasty system relative to the patient to form the bend in the implant plate; i.e. Ricica is silent as to how and when the implant plate is attached to the bone.
Medoff teaches similar method (¶s 78 and 79 disclosed alternative to Fig. 9, Figs. 1-9 disclosure of common features, ¶s 78 and 79) of repositioning bone portions (¶12) in cooperation with a fixation plate and fasteners (¶12) to restore alignment (¶5) and desired spacing of bone fragments (¶79), the method comprising: attaching an implant plate (80) with a bone of a patient (¶s 79, 77, and 74), wherein a lateral side of the plate is attached with a first bone fragment (¶s 79, 77, and 74), and wherein a medial side of the plate is attached with a second bone fragment (¶s 79, 77, and 74); the first and second bone fragments completely disconnected (¶s 5, 79, 77, and 74); engaging a primary instrument (100 of ¶s 78 and 79 disclosed alternative to Fig. 9, ¶s 78 and 79) of a system (¶s 78 and 79 disclosed alternative to Fig. 9, Figs. 1-9 disclosure of common features, ¶s 78 and 79) with the implant plate (¶s 78 and 79); and moving the primary instrument of the system relative to the patient to reposition the bone portions (¶s 78 and 79); wherein the system further comprises a secondary instrument (50) that is reversibly coupled to a handle (30, Figs. 2 and 4A-5D, ¶s 66 and 67) for use in compression or distraction (Figs. 2 and 4A-5D, ¶s 66 and 67), the primary instrument comprising prongs in a U-shape (¶78) that engage the implant plate by wedging underneath a screw head partially threaded into bone (¶s 78 and 79) similar to a conventional pry bar (¶78).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/clarify the method as disclosed by Ricica to comprise attaching the implant plate prior to distracting the full cut in order to strengthen the pivot (Ricica ¶35) on a weakened lamina due to the process of creating the partial cut (Ricica ¶35), i.e. to help ensure that the remaining lamina segment at the partial cut does not break when bent or maintain the original spacing in the event of breakage. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the primary instrument and the second instrument as disclosed by Ricica such that the primary instrument engages the plate via prongs in a U-shape wedged underneath a screwhead when the screw is partially threaded into bone and the secondary instrument has a reversible coupling to the handle as taught by Medoff in order to enable distraction between the bone portions (Medoff ¶79) or compression of a bone portion (Medoff ¶s 66 and 67), e.g. for gripping a bone portion at the selection of the surgeon, on a strengthened pivot (Ricica ¶35) obtained by reinforcing the hinge/pivot by application of the implant plate (Ricica Fig. 3A).
As a result, as to claim 18, the combination of Ricica and Medoff discloses the invention of claim 9 as well as that the step of moving the primary instrument of the cervical laminoplasty system relative to the patient comprises rotating the primary instrument of the cervical laminoplasty system relative to the lateral portion of the first lamina of the vertebra (in order to distract full cut with the plate-reinforced lamina, Ricica Figs. 3A and 5B; Medoff Fig. 9, ¶s 78 and 79).
As to claims 10-12, the combination of Ricica and Medoff discloses the invention of claim 9 as well as the primary instrument comprises a distal portion (Ricica Figs. 5A and 5B; Medoff ¶s 78 and 79) and a secondary instrument comprises a distal portion (Ricica Figs. 5A and 5B; Medoff Figs. 2 and 4A-5D, ¶s 66 and 67), wherein the step of engaging the primary instrument of the cervical laminoplasty system with the implant plate comprises engaging the distal portion of the primary instrument with the implant plate (Medoff ¶s 78 and 79), and wherein a step of engaging the secondary instrument of the cervical laminoplasty system with the full cut comprises engaging the distal portion of the secondary instrument with the full cut (Ricica Figs. 5A and 5B; Medoff Figs. 2 and 4A-5D, ¶s 66 and 67). As to claim 11, the combination of Ricica and Medoff discloses that the medial side of the implant plate comprises an implant post (head of screws/fasteners as best shown in Ricica Fig. 3A, Fig. 3A, ¶35), and the step of engaging the distal portion of the primary instrument with the implant plate comprises engaging the distal portion of the primary instrument with the implant post of the implant plate (Medoff ¶s 78 and 79). As to claim 12, the combination of Ricica and Medoff discloses that the distal portion of the primary instrument comprises a hook (Ricica Fig. 5A; Medoff prongs in a U-shape of ¶78, ¶s 78 and 79), and the step of engaging the distal portion of the primary instrument with the implant post comprises engaging the hook of the distal portion of the primary instrument with the implant post (Medoff ¶s 78 and 79).
The combination of Ricica and Medoff is silent to engaging the distal portion of the primary instrument with the medial side of the implant plate.
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to specify that the distal portion of the primary instrument engages with the medial side of the implant plate, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of wedging the primary instrument underneath a screw head partially threaded into bone (Medoff ¶s 78 and 79) similar to a conventional pry bar (Medoff ¶78) as such is shown to have only two screw holes and corresponding screws in each of the medial and lateral sides (Medoff Figs. 3A-4D). That is, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to specify that the distal portion of the primary instrument engages with the medial side of the implant plate, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious to try from the available two sides of the implant, the engagement of which would provide a predictable solution for gripping the plate-reinforced lamina with a reasonable expectation of success for gripping the lamina as well as distracting the full cut.
As to claim 16, the combination of Ricica and Medoff discloses the invention of claim 9 as well as the bend has an angle (311, Figs. 3A-3D).
The combination of Ricica and Medoff is silent to the bend has an angle of about 60 degrees.
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the bend angle of the combination of Ricica and Medoff to be about 60 degrees, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a bend angle for a particular vertebra (Ricica Fig. 3A) for accommodating various size vertebras (Ricica ¶5) and to increase the diameter of the spinal canal sufficiently so that the pressure on the spinal cord is removed (Ricica ¶5).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775