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 .
Response to Arguments
Applicant's arguments filed April 2nd, 2026 have been fully considered but they are not persuasive. Applicant argues that Khanna fails to teach or disclose “a fastener connecting the upper portion of the bracket to the base, the fastener configured to pass through at least one of an opening in the base and an opening in the upper portion of the bracket to incrementally adjust a distance between the base and the upper portion of the bracket.” The Examiner respectfully disagrees with this assertion. The elastomeric band of Khanna provides incremental adjustment as the lengthening/stretching of the elastic band is incremental in nature and the adjustments in the length/spacing between the base and the upper portion of the bracket.
Additionally, Applicant argues that Sikander does not disclose a fixation device and that figure 2 of Sikander illustrates an adjustable bone plant used in conjunction with an anchoring member to secure a second bone surface in place in a raised position which is not a fixation device. The Examiner notes that the device of Sikander is indeed a fixation device as it fixates the two bone surfaces to one another and can maintain them in a fixed raised position if one so desires. Further, Applicant argues that spacing member 120 is not analogous, or comparable to, a fastener as recited in the pending claims. The Examiner notes that the fastener of Sikander satisfies all the structural and functional limitations of the claims and therefore is as much a fastener as Applicant’s. Further, both the prior art and Applicant’s invention require a threaded coupling between two threaded spindles as their “fastener”. The Examiner is unclear how their structure 120 can be considered a “fastener” while the prior art is not. Additional clarification is kindly requested. Lastly, Applicant argues that the second surface of Khanna is not “substantially flush with the first surface”. Figure 5 of Khanna clearly shows that the two respective surfaces are substantially (emphasis added) flush.
As a result, Applicant’s arguments and remarks are not found persuasive to overcome the prior art and rejections of record.
Claim Rejections - 35 USC § 102
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, 4, 10-13, 15 and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khanna (US 2012/0184999).
Regarding claim 1, Khanna discloses a fixation device comprising a base (11, figures 5-10) having a first axial end (see figure below) and a second axial end (see figure below) as measured along a longitudinal axis of the fixation device, the base configured to be attached to a first surface (figures 26-27); a bracket (13) positioned above the base, the bracket comprising an upper portion (see figure below) having a first axial end (see figure below) and a second axial end (see figure below) as measured along the longitudinal axis; a lower portion (see figure below) having a first axial end (see figure below) and a second axial end (see figure below) as measured along the longitudinal axis, the lower portion configured to be attached to a second surface; and an intermediate portion (see figure below) connecting the second axial end of the upper portion to the first axial end of the lower portion; and a fastener (15) connecting the upper portion of the bracket to the base (figures 5-10), the fastener configured to pass through at least one of an opening in the base (see figure below) and an opening in the upper portion of the bracket to incrementally adjust a distance between the base and the upper portion of the bracket (¶138).
Regarding claim 2, Khanna disclose the intermediate portion of the bracket is substantially perpendicular to the longitudinal axis such that the bracket is substantially Z- shaped (figure 5).
Regarding claim 4, Khanna discloses the intermediate portion of the bracket is angled, and the second axial end of the base has an angled upper surface that corresponds to the angled intermediate portion of the bracket (figure 5).
Regarding claim 10, Khanna discloses the base is attached to the first surface via fasteners (“screws” ¶138) and the lower portion of the bracket is attached to the second surface via fasteners (“screws” 138).
Regarding claim 11, Khanna discloses the first surface is a skull of a patient (68, figures 26-27), and the second surface is a bone flap of the skull (65, figures 26-27).
Regarding claim 12, Khanna discloses an adjustable cranial fixation system comprising a patient having a skull (68); a bone flap (65) removed from the skull thereby forming a hole in the skull (figures 26-27); and a plurality of fixation devices (figures 26-27) positioned around the perimeter of the hole in the skull (figure 1), each of the plurality of fixation devices comprising a base (11, figures 5-10) having a first axial end (see figure below) and a second axial end (see figure below) as measured along a longitudinal axis of the fixation device, the base is attached to the skull adjacent the hole (figures 26-27); a bracket (13) positioned above the base, the bracket comprising an upper portion (see figure below) having a first axial end (see figure below) and a second axial end (see figure below) as measured along the longitudinal axis; a lower portion (see figure below) having a first axial end (see figure below) and a second axial end (see figure below) as measured along the longitudinal axis, the lower portion is attached to the bone flap adjacent a perimeter edge thereof (figures 26-27); and an intermediate portion (see figure below) connecting the second axial end of the upper portion to the first axial end of the lower portion; and a fastener (15) connecting the upper portion of the bracket to the base, the fastener configured to pass through at least one of an opening in the base (see figure below) and an opening in the upper portion of the bracket to incrementally adjust a distance between the base and the upper portion of the bracket (¶138).
Regarding claim 13, Khanna discloses the intermediate portion of the bracket is substantially perpendicular to the longitudinal axis such that the bracket is substantially Z- shaped (figure 5) Regarding claim 15, Khanna discloses the intermediate portion of the bracket is angled, and the second axial end of the base has an angled upper surface that corresponds to the angled intermediate portion of the bracket (figures 5-6).
Regarding claim 21, Khanna discloses wherein the is base configured to be attached to the skull via fasteners (“screws” ¶138) and the lower portion of the bracket is attached to the bone flap via fasteners (“screws” ¶138). Regarding claim 22, Khanna discloses the plurality of fixation devices are positioned such that the longitudinal axis of each fixation device is substantially aligned with a radial line of the hole in the skull (figures 26-27).
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Claims 1, 6-9, 12 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sikander (US 2020/0197118).
Regarding claim 1, Sikander discloses a fixation device comprising a base (110) having a first axial end (see figure below) and a second axial end (see figure below) as measured along a longitudinal axis of the fixation device, the base configured to be attached to a first surface; a bracket (130) positioned above the base, the bracket comprising an upper portion (134) having a first axial end (see figure below) and a second axial end (see figure below) as measured along the longitudinal axis; a lower portion (138a) having a first axial end (see figure below) and a second axial end (see figure below) as measured along the longitudinal axis, the lower portion configured to be attached to a second surface; and an intermediate portion (132) connecting the second axial end of the upper portion to the first axial end of the lower portion; and a fastener (120) connecting the upper portion of the bracket to the base, the fastener configured to pass through at least one of an opening in the base (112) and an opening in the upper portion of the bracket (opening in 138, figure 2) to incrementally adjust a distance between the base and the upper portion of the bracket (¶31).
Regarding claim 6, Sikander discloses the fastener comprises a cylindrical member (120, figures 2-4) having a threaded exterior circumferential surface (122a) thereon, and at least one of the opening (¶27) in the base and the opening in the upper portion of the bracket is defined by a threaded interior circumferential surface (112) configured to engage the threaded exterior circumferential surface of the fastener (figures 2-4). Regarding claim 7, Sikander discloses the fastener is a telescoping fastener (¶36) comprising an inner member (124) and an outer member (122), the inner member is configured to be retained within a bore of the outer member (“threaded bore” ¶31), and the outer member is configured to pass through at least one of the opening in the base and the opening in the upper portion of the bracket (figures 2-4).
Regarding claim 8, Sikander discloses the inner member is cylindrical having a threaded exterior circumferential surface (124a) thereon, and the bore of the outer member is cylindrical and is defined by a threaded interior circumferential surface (“threaded bore” ¶31) configured to engage the threaded exterior circumferential surface of the inner member (¶31).
Regarding claim 9, Sikander discloses the outer member is cylindrical (figures 2-4) having a threaded exterior circumferential surface (122a) thereon, and at least one of the opening in the base and the opening in the upper portion of the bracket is defined by a threaded interior circumferential surface (112) configured to engage the threaded exterior circumferential surface of the outer member (figures 2-4).
Regarding claim 12, Sikander discloses an adjustable cranial fixation system for use on a patient having a skill with a bone flap removed from the skull thereby forming a hole in the skull comprising a plurality of fixation devices (100’s, figure 1) positionable around the perimeter of the hole in the skull (figure 1), each of the plurality of fixation devices comprising a base (110) having a first axial end (see figure below) and a second axial end (see figure below) as measured along a longitudinal axis of the fixation device, the base is configured to be attached to the skull adjacent the hole (Figures 1, 3-4); a bracket (130) positioned above the base, the bracket comprising an upper portion (134) having a first axial end (see figure below) and a second axial end (see figure below) as measured along the longitudinal axis; a lower portion (138a) having a first axial end (see figure below) and a second axial end (see figure below) as measured along the longitudinal axis, the lower portion is configured to be attached to the bone flap adjacent a perimeter edge thereof (figures 1, 3-4); and an intermediate portion (132) connecting the second axial end of the upper portion to the first axial end of the lower portion; and a fastener (120) connecting the upper portion of the bracket to the base, the fastener configured to pass through at least one of an opening in the base (112) and an opening in the upper portion of the bracket to incrementally adjust a distance between the base and the upper portion of the bracket (¶31).
Regarding claim 17, Sikander discloses the fastener comprises a cylindrical member (120, figures 2-4) having a threaded exterior circumferential surface (122a) thereon, and at least one of the opening in the base (¶27) and the opening in the upper portion of the bracket is defined by a threaded interior circumferential surface (112) configured to engage the threaded exterior circumferential surface of the fastener (figures 2-4). Regarding claim 18, Sikander discloses the fastener is a telescoping fastener (¶36) comprising an inner member (124) and an outer member (122), the inner member is configured to be retained within a bore of the outer member (“threaded bore” ¶31), and the outer member is configured to pass through at least one of the opening in the base and the opening in the upper portion of the bracket (figures 2-4). Regarding claim 19, Sikander discloses the inner member is cylindrical having a threaded exterior circumferential surface thereon (124a), and the bore of the outer member is cylindrical and is defined by a threaded interior circumferential surface (“threaded bore” ¶31) configured to engage the threaded exterior circumferential surface of the inner member (¶31). Regarding claim 20, Sikander discloses the outer member is cylindrical (figures 2-4) having a threaded exterior circumferential surface (122a) thereon, and at least one of the opening in the base (112) and the opening in the upper portion of the bracket is defined by a threaded interior circumferential surface configured to engage the threaded exterior circumferential surface of the outer member (figures 2-4).
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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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3, 5, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Khanna (US 2012/0184999).
Regarding claim 3, Khanna discloses the claimed invention including when the
wherein when the distance between the base and the upper portion of the bracket is fully reduced by the fastener the first axial end of the lower portion of the bracket is in close proximity with the second axial end of the base such that the second surface is substantially flush with the first surface (figure 5).
However, Khanna fails to expressly teach or disclose that the first axial end of the lower portion of the bracket abuts the second axial end of the base and there appears to be a small gap between the two axial ends.
It would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the first axial end of the lower portion and the second axial end of the base to abut one another in the fully reduced position, since applicant has not disclosed that having the two surface abutting such solves any stated problem or is for any particular purpose other than aesthetics.
Regarding claim 5, Khanna discloses the claimed invention including the distance between the base and the upper portion of the bracket is fully reduced by the fastener a bottom surface of the angled intermediate portion of the bracket is in close proximity with the angled upper surface of the second axial end of the base such that the second surface is substantially flush with the first surface (figure 5). However, Khanna fails to expressly teach or disclose the bottom surface of the angled intermediate portion of the bracket abuts the angled upper surface of the second axial end of the base. It would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the angled intermediate portion of the bracket abutting the angled upper surface of the second axial end of the base, since applicant has not disclosed that having the two surface abutting such solves any stated problem or is for any particular purpose other than aesthetics.
Regarding claim 14, Khanna discloses the claimed invention including when the
wherein when the distance between the base and the upper portion of the bracket is fully reduced by the fastener the first axial end of the lower portion of the bracket is in close proximity with the second axial end of the base such that the second surface is substantially flush with the first surface (figure 5).
However, Khanna fails to expressly teach or disclose that the first axial end of the lower portion of the bracket abuts the second axial end of the base and there appears to be a small gap between the two axial ends.
It would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the first axial end of the lower portion and the second axial end of the base to abut one another in the fully reduced position, since applicant has not disclosed that having the two surface abutting such solves any stated problem or is for any particular purpose other than aesthetics.
Regarding claim 16, Khanna discloses the claimed invention including when the
wherein when the distance between the base and the upper portion of the bracket is fully reduced by the fastener the first axial end of the lower portion of the bracket is in close proximity with the second axial end of the base such that the bone flap is substantially flush with the skull (figure 5).
However, Khanna fails to expressly teach or disclose that the first axial end of the lower portion of the bracket abuts the second axial end of the base and there appears to be a small gap between the two axial ends.
It would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the first axial end of the lower portion and the second axial end of the base to abut one another in the fully reduced position, since applicant has not disclosed that having the two surface abutting such solves any stated problem or is for any particular purpose other than aesthetics.
Conclusion
THIS ACTION IS MADE FINAL. 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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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