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 .
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) 14-20 and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al (US Pub 2014/0172027) in view of Appenzeller et al. (US Pub 2009/0157123).
With respect to claim 14, Biedermann et al. discloses an implant (see fig 20 below) comprising: a head (Fig 20, 33) and an extension member (fig 20, 2’’’ being a unitary member (fig 20) with and extending directly from the head (fig 20), the head being free of threads (fig 20); a fastener body (fig 20, 1’’) having an externally threaded region (see fig 20 below) with a distal tip (fig 20, 22) and a proximal portion having a proximal end (fig 20) furthest from the distal tip along a longitudinal axis (fig 20, L) of the fastener body, and the fastener body including a circumferentially extending gap (fig 20, 38) between an outer surface (Fig 20, 13) of the fastener body and the extension member.
With respect to claim 15, Biedermann et al. discloses wherein the proximal portion bends relative to the longitudinal axis of the threaded region only along a single axis (paragraph 14, shape of the extension member can be varied so that the bending is different in different directions and figure 14 shows bending in one axis) perpendicular to the longitudinal axis of the fastener body.
With respect to claim 16, Biedermann et al. discloses wherein a radial distance between an inner surface of the gap and an outer surface of the gap varies between a first direction perpendicular to the longitudinal axis and a second direction perpendicular to the first direction and the longitudinal axis (paragraph 14, different shaped extension.
With respect to claim 17, Biedermann et al. discloses wherein the externally threaded region is configured to be inserted into a bone of a patient in an in-use position (fig 14, 101) and part of the proximal end remains exposed (fig 14 the head is out of the bone) from the bone in an in-use position.
With respect to claim 18, Biedermann et al. discloses wherein the proximal portion includes a tool receiving compartment (fig 20, 34) to permit rotation of the fastener body to secure the threaded region into the bone of a patient, wherein the bone is a spinal bone.
With respect to claim 19, Biedermann et al. discloses wherein the proximal portion of the fastener body that has no bone fixation properties and extends outside the bone in the in-use position, the proximal portion includes a spherical or any other shape to be connected to an orthopedic system (fig 20, 3 is spherical and is shown attached to a rod receiver in fig 13 and a plate in fig 14).
PNG
media_image1.png
285
562
media_image1.png
Greyscale
With respect to claim 14, Biedermann et al. discloses the claimed invention except for the fastener body includes a deformation region closer to the proximal portion than the distal tip that deforms upon an application of a force to the proximal portion allowing the proximal portion to bend relative to the longitudinal axis of the fastener body.
Appenzeller et al. discloses a fastener body (see fig 14 below)) includes a deformation region (Fig 14, 131’’) closer to the proximal portion ( fig 14, left side) than the distal tip that deforms upon an application of a force to the proximal portion allowing the proximal portion to bend relative to the longitudinal axis of the fastener body (paragraph 84) to control flexibility and protect the structural integrity (paragraph 84).
With respect to claim 33, Appenzeller et al. discloses wherein a convex portion (see fig 14 below) of the head contacts a proximal position (fig 14, 131’’) of the fastener body that is furthest from the distal tip (see fig 14 below).
PNG
media_image2.png
322
505
media_image2.png
Greyscale
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 device of Biedermann et al. to include the fastener body includes a deformation region closer to the proximal portion than the distal tip that deforms upon an application of a force to the proximal portion allowing the proximal portion to bend relative to the longitudinal axis of the fastener body in view of Appenzeller et al. in order to control flexibility and protect the structural integrity.
With respect to claim 34, Biedermann et al. in view of Appenzeller et al. discloses where a distal portion of the head includes a circumferential tab portion (fig 20, 21B) extending into the gap and positioned between an outer wall and an inner wall of the gap (fig 20 shows the transition region 21B extending from the inner wall formed by the extension to the outer wall formed by the body).
With respect to claim 20, Biedermann et al. discloses an orthopedic fastener (See fig 20 above) comprising: a fastener body having a head (fig 20, 33) a neck (See fig 20 above), a threaded body (fig 20, 1’’) and a distal tip (fig 20, 22), an extension member (fig 20, 2’’’) being a unitary member (see fig 20 above) with and extending directly from the head, the head being free of threads (fig 20) and the fastener body including circumferentially extending gap (fig 20, 38) between an outer surface of the fastener body and a longitudinal axis of the fastener body (fig 20, L), the extension member being located between the gap and the longitudinal axis of the threaded body (fig 20).
With respect to claim 20, Biedermann et al. discloses the claimed invention except for the body being hermetically sealed with the neck including a deformation region proximate the head that deforms upon an application of a force to the head allowing the head to bend relative to the longitudinal axis of the threaded body.
Appenzeller et al. discloses the body being hermetically sealed (See fig 14 above) with the neck including a deformation region (fig 14, 131) proximate the head that deforms upon an application of a force to the head allowing the head to bend relative to the longitudinal axis of the threaded body (paragraph 84) to control flexibility and protect the structural integrity (paragraph 84).
With respect to claim 35, Appenzeller et al. discloses wherein a convex portion (see fig 14 below) of the head contacts a proximal position (fig 14, 131’’) of the fastener body that is furthest from the distal tip (see fig 14 below).
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 device of Biedermann et al. to include the body being hermetically sealed with the neck including a deformation region proximate the head that deforms upon an application of a force to the head allowing the head to bend relative to the longitudinal axis of the threaded body in view of Appenzeller et al. in order to control flexibility and protect the structural integrity.
With respect to claim 36, Biedermann et al. in view of Appenzeller et al. discloses where a distal portion of the head includes a circumferential tab portion (fig 20, 21B) extending into the gap and positioned between an outer wall and an inner wall of the gap (fig 20 shows the transition region 21B extending from the inner wall formed by the extension to the outer wall formed by the body).
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive. The applicant argues that claims 21-28, newly added after the restriction requirement should be examined because the restriction requirement was to a generic implant. The examiner respectfully disagrees. The requirement was to an implant classified in A61F2/4611 which is directed to spinal implants. The subject matter in claim 21-28 includes an apical region which is directed to the dental implant. Only the dental implant is disclosed to having an apical region in the specification. The original restriction requirement makes it clear that invention I is directed to an implant with an apical end and claims directed to that would fall under non-elected invention I stating “for invention I that is the implant body having a coronal and apical end which has a compartment with a gap for a dental prosthetic and movable internal surface that is sealed” such that claim 21 and its dependents are directed to invention I.
Applicant’s arguments with respect to claim(s) 14-20 and 33-36 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. To overcome the rejection the applicant could specify that the circumferential tab has an overhang extending over a portion of the extension member.
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 STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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, Eduardo Robert can be reached at (571) 272-4719. 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.
/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights