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 Amendment
This office action is in response to the amendment filed August 26, 2025. As directed by the amendment, claims 1 and 11 have been amended and claims 3-5 and 13-15 were previously withdrawn. As such, claims 1-2, 6-12, 16-22 remain under consideration in the instant application.
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) 1-2, 6-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hollis et al. (US 2020/0305940), hereinafter Hollis.
Regarding claim 1, Hollis discloses a bone fixation system (100) for a fractured bone having at least one bone fragment, the bone fixation system comprising: a bone anchor (110) capable to matingly engage with at least one opening in a bone plate, the bone anchor comprising a cannula (FIG. 1C) extending through at least a portion of an interior of the bone anchor; and at least one elongated member (120) comprising an anchor connector portion (126), at least one support portion (122), and at least one fragment connector portion (124), wherein the anchor connector portion extends from a proximal end of the at least one support portion and the at least one fragment connector portion extends from a distal end of the at least one support portion (FIGS. 4A-4B), wherein the elongated member is capable to extend between the interior of the bone anchor and an outer surface of the bone, whereby the anchor connector portion is configured to matingly engage within the cannula in the bone anchor to thereby secure the elongated member within the bone anchor (FIG. 1C), and wherein the at least one fragment connector portion is capable to anchor the at least one bone fragment in place against a remainder of the fractured bone, and wherein the at least one fragment connector portion is capable to anchor the at least one bone fragment in place without predrilling a hole into the bone fragment (“the staple component 120 to return towards its biased configuration, thereby providing a compressive force between the bone engaging member 125 and the center post 110. This compressive force can maintain compression across a bone fracture”, ¶51).
Regarding claim 2, Hollis discloses the system of claim 1, wherein the at least one support portion of the elongated member has a linear configuration (FIG. 1B).
Regarding claim 6, Hollis discloses the system of claim 1, wherein at least a portion of the elongated member is formed of a rigid material (¶26).
Regarding claim 7, Hollis discloses the system of claim 1, wherein at least a portion of the elongated member is formed of a contourable material (¶26).
Regarding claim 8, Hollis discloses the system of claim 7, wherein at least a portion of the elongated member is formed of a shape memory alloy (¶26).
Regarding claim 9, Hollis discloses the system of claim 8, wherein at least a portion of the at least one fragment connector portion of the elongated member is formed of nitinol, wherein the nitinol compresses to embrace and anchor the bone fragment to the remaining bone (¶26).
Claim(s) 11-12, 16-19, 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hollis et al. (US 2025/0000557), hereinafter “Hollis 2”.
Regarding claim 11, Hollis 2 discloses a bone fixation system (100) for a fractured bone having at least one fragment, the bone fixation system comprising: a bone plate (200) configured and adapted to be attached to a surface of a fractured bone, the plate comprising at least one opening (210) therein; a bone anchor (200) configured and adapted to matingly engage with the at least one opening in the bone plate, the bone anchor comprising a cannula (305) extending through at least a portion of an interior of the bone anchor; and at least one elongated member (400) comprising an anchor connector portion (430), at least one support portion (410), and at least one fragment connector portion (420), wherein the anchor connector portion extends from a proximal end of the at least one support portion and the at least one fragment connector portion extends from a distal end of the at least one support portion (FIG. 4A), wherein the elongated member is capable to extend between the interior of the bone anchor and an outer surface of the bone (FIG. 1A); and wherein the bone plate is capable of being placed adjacent a surface of the fractured bone, the bone anchor is disposed within the at least one opening in the bone plate and through the bone plate into the bone (FIG. 1A), the anchor connector portion of the elongated member is disposed in and matingly engage within the cannula in the bone anchor to thereby secure the elongated member within the bone anchor (FIG. 1C), and the at least one fragment connector portion of the elongated member is capable of extending beyond the bone plate and is capable of contacting at least one fractured fragment of the bone to anchor the at least one bone fragment in place against a remainder of the fractured bone (FIG. 1A), and wherein the at least one fragment connector portion is capable to anchor the at least one bone fragment in place without predrilling a hole into the bone fragment (“staple component 400…may be released to create a compressive force holding together the second metatarsal 50 and the intermediate cuneiform bone 20”, ¶110).
Regarding claim 12, Hollis 2 discloses the system of claim 11, wherein the at least one support portion of the elongated member has a linear configuration (FIG. 4D.
Regarding claim 16, Hollis 2 discloses the system of claim 11, wherein at least a portion of the elongated member is formed of a rigid material (¶62).
Regarding claim 17, Hollis 2 discloses the system of claim 11, wherein at least a portion of the elongated member is formed of a contourable material (¶62).
Regarding claim 18, Hollis 2 discloses the system of claim 17, wherein at least a portion of the elongated member is formed of a shape memory alloy (¶62).
Regarding claim 19, Hollis 2 discloses the system of claim 18, wherein at least a portion of the at least one fragment connector portion of the elongated member is formed of nitinol, wherein the nitinol compresses to embrace and anchor the at least one bone fragment to the remaining bone (¶62).
Regarding claim 21, Hollis 2 discloses the system of claim 11, wherein the bone plate is capable to be attached to a distal ulnar surface of a radius.
Regarding claim 22, Hollis 2 discloses the system of claim 11, wherein the bone plate is capable to be attached to a volar ulnar surface of a radius.
Allowable Subject Matter
Claims 10 and 20 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 10, Hollis discloses a bone fixation system (100) for a fractured bone having at least one bone fragment, the bone fixation system comprising: a bone anchor (110) capable to matingly engage with at least one opening in a bone plate, the bone anchor comprising a cannula (FIG. 1C) extending through at least a portion of an interior of the bone anchor; and at least one elongated member (120) comprising an anchor connector portion (126), at least one support portion (122), and at least one fragment connector portion (124), wherein the anchor connector portion extends from a proximal end of the at least one support portion and the at least one fragment connector portion extends from a distal end of the at least one support portion (FIGS. 4A-4B), wherein the elongated member is capable to extend between the interior of the bone anchor and an outer surface of the bone, whereby the anchor connector portion is configured to engage within the cannula in the bone anchor (FIG. 1C), and wherein the at least one fragment connector portion is capable to anchor the at least one bone fragment in place against a remainder of the fractured bone. However, the prior art, alone or in combination, fails to teach wherein the anchor connector portion of the elongated member is configured to extend through/beyond the bone anchor and into the bone.
Response to Arguments
In response to Applicant's argument that the Hollis references fail to teach the fragment connector portion capable of anchoring the at least one bone fragment in place without predrilling a hole into the bone fragment, Examiner respectfully disagrees. Applicant’s invention states “the fragment connector portion(s) of the elongated member frictionally engages, surrounds, compresses, and/or otherwise embraces at least a portion of an outer surface of the at least one fractured fragment of the bone to thereby anchor the at least one fractured fragment of the bone in place against a remainder of the bone” (¶62). Similarly, the Hollis references teach its fragment connector portions comprising a “biased configuration” wherein its “compressive force can maintain compression across a bone fracture” (¶51). Therefore, the Hollis system is capable of anchoring the at least one bone fragment in place without predrilling a hole into the bone fragment.
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 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA C CHANG whose telephone number is (571) 270-5017. The examiner can normally be reached Monday-Friday, 7:30AM-5:00PM.
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.
/OLIVIA C CHANG/Primary Examiner, Art Unit 3775
Prosecution Insights