DETAILED ACTION
This office action is responsive to the amendment filed December 30, 2025. By that amendment, claims 1, 2, 9-11, 17 and 18 were amended; claim 8 was canceled; and claims 21-24 were newly presented. Claims 1-7 and 9-24 are pending.
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 with respect to claim(s) 1-7 and 9-20 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. The newly presented rejections were necessitated by the amendments to the claims of December 30, 2025.
Claim Interpretation
At least claims 3 and 5 include limitations presented in the alternative. Once a single of the claimed alternatives is shown to be present in the prior art, the further alternatives are not required to be given any additional consideration.
Claims 6 and 16 claim a contoured shape “created by projecting an elongate area defined on a sagittal plane onto a medical epicondylar bone surface…” Examiner interprets this as essentially non-limiting. Examiner is of the position that the linear construction of the Frigg device is a contour which can be aligned with some sagittal plan and ‘defined on’ some surface of a bone. The limitation simply does not require any structural requirement of the claimed device which is not met by any device being placed in the claimed location.
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.
Claim(s) 1-4, 6, 7, 9-11, 14, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frigg et al. (US 2010/0262193 A1).
Regarding claim 1, Frigg teaches a tether assembly at fig. 9 attachable to a bone 10 as in fig. 1 comprising a growth plate that separates a first section of the bone from a second section of the bone (there being no reason Frigg’s tether assembly cannot be attached to such a bone), the tether assembly comprising:
a tether member 200 comprising:
a first end (up in fig. 9);
a second end (down in fig. 9); and
a central portion (middle portion in fig. 9) extending between the first end and the second end (up/down);
wherein:
the first end comprises a closed outer wall that defines and fully bounds a first aperture 203;
the second end comprises an open outer wall that defines and partially bounds a second aperture 204, the open outer wall defining a slot in communication with the second aperture as seen in fig. 9;
the first end is capable of being secured to the first section of the bone via a first coupling member 116 inserted through the first aperture 203 and anchored in the first section (as shown, for example, in fig. 1); and
the second end is capable of being secured to the second section of the bone via a second coupling member 116 inserted through the second aperture 204 and anchored in the second section (as shown, for example, in fig. 1);
the slot of 204 extends from the second aperture away from the first end as seen in fig. 9; and
the slot of 204 is oriented at an acute angle relative to a longitudinal axis L of the central portion as seen in fig. 9.
Based on the disclosure, examiner sees no reason that a plate device 200 of Frigg does not read on the claimed tether.
Regarding claim 2, the tether assembly further includes:
the first coupling member 116; and
the second coupling member 116;
wherein:
the first coupling member 116 comprises:
a first head 118; and
a first shank 120 comprising a first bone engagement feature (thread on 120) configured to retain the first shank 120 in the bone as in fig. 1; and
the second coupling member 116 comprises:
a second head 118; and
a second shank 120 comprising a second bone engagement feature (thread on 120) configured to retain the second shank in the bone.
Regarding claim 3, the second shank 120 comprises a second shank width and the second head 118 comprises a second head width, wherein the second head width is not smaller than a corresponding portion of the slot of 204 through which it must pass in order to exit the second aperture through the slot (seen best in fig. 2), such that the second coupling member 116 is movable through the slot of 204 only in response to exertion of a threshold level of tension between the second coupling member and the second end (at least when the head is screwed down to the bone plate).
Regarding claim 4, the corresponding portion of the slot is configured to deform elastically to permit passage of the second shank therethrough in response to exertion of the threshold level of tension: as at [0014], the plate is formed of TAN, steel or plastic such as PEEK. Examiner finds it to be inherent that each of these materials is capable of deforming elastically some amount to permit passage of the shank 120 through the slot of 204 upon application of an appropriate level of force, thereto.
Regarding claim 6, (see interpretation of claims section), the central portion (middle portion of fig. 9) comprises a contoured shape as claimed, including a long axis (up/down in fig. 9) and a short axis orthogonal to the long axis.
Regarding claim 7, the long axis as measured on the sagittal plane is positioned at an angle relative to a mentally constructed transverse plane; and the angle is within the range of 30 to 60 degrees. As written the transverse plane relates to no structures so can be mentally designated as existing anywhere on the Frigg device.
Regarding claim 9, the acute angle is within the range of 0 to 80 as can be seen in fig. 9.
Regarding claim 10, Frigg teaches a tether assembly as at fig. 9 attachable to a bone comprising a growth plate that separates a first section of the bone from a second section of the bone, the tether assembly comprising:
a first coupling member 116 comprising:
a first head 118; and
a first shank 120 comprising a first bone engagement feature (threads) configured to retain the first shank 120 in the bone;
a second coupling member 116 comprising:
a second head 118; and
a second shank 120 comprising a second bone engagement feature (threads) configured to retain the second shank 120 in the bone; and
a tether member 202 comprising:
a first end (up in fig. 9);
a second end (down in fig. 9); and
a central portion extending between the first end and the second end (portion between top and bottom);
wherein:
the first end (up in fig. 9) is configured to engage the first head 118 to nonreleasably secure the first end to the first section of the bone at an aperture 203; and
the second end (down in fig. 9) is configured to engage the second head 118 to releasably secure the second end to the second section of the bone such that, in response to exertion of a threshold level of tension between the second coupling member 116 and the second end of 202, the second end is released from the second section of the bone: as at [0014], the plate is formed of TAN, steel or plastic such as PEEK. Examiner finds it to be inherent that each of these materials is capable of deforming elastically some amount to permit passage of the shank 120 through the slot of 204 upon application of an appropriate level of force, thereto;
the second end comprises an open outer wall at 204 that defines and partially bounds a second aperture 204;
the open outer wall defines a slot in communication with the second aperture 204; and
the slot extends from the second aperture away from the first end as at fig. 9.
Regarding claim 11, the first end comprises a fully-bounded first aperture 203.
Regarding claim 14, as can be seen at fig. 9, the slot is oriented non-perpendicular to a longitudinal length of the central portion.
Regarding claim 16, (see interpretation of claims section), the central portion (middle portion of fig. 9) comprises a contoured shape as claimed, including a long axis (up/down in fig. 9) and a short axis orthogonal to the long axis.
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.
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frigg.
Regarding claims 5 and 15, Frigg teaches the limitations of claims 2 and 10, as above. Further, Frigg makes clear the plate hole and the screw head having identical surfaces, in discussion related to beveled configurations 114.
Frigg does not teach use of screws with spherical heads.
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify Frigg to have spherical seats and spherical head screws. It is well known in this art to use spherical head screws in combination with plates with spherical fastener seats to permit use of screws in variable-angle insertions. One would have done so in order to permit the Frigg device to be utilized in more complicated bone and fracture arrangements. A spherical head screw is considered one type of commonly used surgical screw which it would have been obvious to use with the Frigg device with only slight modification.
Allowable Subject Matter
Claims 12 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 17-24 are allowed.
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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, please contact the examiner’s supervisor, Kevin 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.
/DAVID W BATES/Primary Examiner, Art Unit 3799
Prosecution Insights