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 .
Election/Restrictions
New claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 14, 2025.
Claim Rejections - 35 USC § 102
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 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, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krauss et al. (US 2017/0209192 A1).
Claim 1. Krauss discloses a bone fragment manipulation device (instrument 10) for use with a k-wire, the device comprising:
a first tool component (second arm member 30) having a first elongated member (proximal portion 32, intermediate portion 33, and distal portion 34) extending from a proximal end (end where proximal portion 32 attaches to handle 70) to a distal end (end of distal portion 34 at engagement feature 36), the distal end having a spike (see para. 0040, which states that engagement feature 36 includes spikes);
a second tool component (first arm member 20) having a second elongated member (proximal portion 22 and distal portion 24) extending from a proximal end (end where proximal portion 22 attaches to handle 70) to a distal end (end of distal portion 24 at support/guide member 50) and having an outer surface defining an opening (see Fig. 2C, which shows an opening at ring portion 52) configured to receive the k-wire (the opening can receive a k-wire in the same manner as drill bit 130 as shown in Figs. 7A-7B), the distal end of the second tool component having a tamp (second end portion 56, which includes wall portions 56a-b); and,
a handle (handle 70) disposed between the first tool component and the second tool component, wherein the handle has a first end (free end of handle 70) and an opposing second end (end of handle 70 directly connected to second arm member 30 at a location near pivot 12), wherein the first end of the handle is connected to the proximal end of the second tool component (via an indirect connection to first arm member 20 with the remainder of handle 70 and second arm member 30 acting as intermediary connecting components), and wherein the second end of the handle is connected to the proximal end of the first tool component (via a direct connection to second arm member 30) (Figs. 1-7B; paras. 0027-0053).
Claim 2. Krauss discloses wherein the spike is mounted on a spherical ball (see para. 0040, which states that engagement feature 36 is a sphere) and configured to engage with bone fragments (Figs. 1-7B; paras. 0027-0053).
Claim 7. Krauss discloses wherein the tamp includes a serrated edge (defined by wall portions 56a-b) having multiple projections (wall portions 56a-b) extending from the distal end of the second elongated member (Figs. 1-7B; paras. 0027-0053).
Claim 8. Krauss discloses wherein the second elongated member includes a cavity (see Figs. 2A and 2D, which show a cavity extending from the opening toward second end portion 56) extending from the opening to the distal end of the second elongated member and configured to receive the k-wire slidably disposed within the cavity from the opening and through the tamp at the distal end of the second elongated member (the cavity can receive a k-wire in the same manner as drill bit 130 as shown in Figs. 7A-7B) (Figs. 1-7B; paras. 0027-0053).
Claim 9. Krauss discloses a guiding member (guide 120) configured to be fixedly retained within the cavity of the second elongated member, the guiding member having a sidewall extending from a first end (end adjacent opening 124) to a second end (end adjacent second end portion 56 of support/guide member 50 as shown in Fig. 7B) and defining a first cavity (see Fig. 7B, which shows a cavity through guide 120) configured to retain the k-wire (the cavity can receive a k-wire in the same manner as drill bit 130 as shown in Figs. 7A-7B) (Figs. 1-7B; paras. 0027-0053).
Claims 1, 3-7, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siebrandt (US 2,181,746 A).
Claim 1. Siebrandt discloses a bone fragment manipulation device (see Fig. 1) for use with a k-wire, the device comprising:
a first tool component (lower jaw 14) having a first elongated member (lower jaw 14) extending from a proximal end (end where lower jaw 14 attaches to handle portions 10 and 11) to a distal end (end of lower jaw 14 at serrations 15), the distal end having a spike (any one of serrations 15);
a second tool component (upper jaw 12) having a second elongated member (upper jaw 12) extending from a proximal end (end where upper jaw 12 attaches to handle portions 10 and 11) to a distal end (end of upper jaw 12 at serrations 15) and having an outer surface defining an opening (slot 19) configured to receive the k-wire (the opening can receive a k-wire in the same manner as drill bit 27 as shown in Fig. 2), the distal end of the second tool component having a tamp (surface with serrations 15); and,
a handle (handle portions 10 and 11) disposed between the first tool component and the second tool component, wherein the handle has a first end (end of handle portion 10 directly connected to upper jaw 12 at a location near pivot 16) and an opposing second end (end of handle portion 11 at a location near rod 40), wherein the first end of the handle is connected to the proximal end of the second tool component (via a direct connection to upper jaw 12), and wherein the second end of the handle is connected to the proximal end of the first tool component (via an indirect connection to lower jaw 14 with the remainder of handle portion 11 acting as an intermediary connecting component) (Figs. 1-3; pg. 1, col. 2, l. 26 through pg. 2, col. 2, l. 41).
Claim 3. Siebrandt discloses wherein the first elongated member includes a first arched portion (lower jaw 14 is arched as shown in Fig. 1) extending from the handle at a first angle and symmetrically curving from the proximal end to the distal end of the first elongated member (see Fig. 1) (Figs. 1-3; pg. 1, col. 2, l. 26 through pg. 2, col. 2, l. 41).
Claim 4. Siebrandt discloses wherein the second elongated member includes a second arched portion (upper jaw 12 is arched as shown in Fig. 1) extending from the handle at a second angle and symmetrically curving from the proximal end to the distal end of the second elongated member (see Fig. 1) (Figs. 1-3; pg. 1, col. 2, l. 26 through pg. 2, col. 2, l. 41).
Claim 5. Siebrandt discloses wherein the first angle and the second angle are approximately congruent angles (see Fig. 1, which shows that the curvatures of upper jaw 12 and lower jaw 14 are mirror images) (Figs. 1-3; pg. 1, col. 2, l. 26 through pg. 2, col. 2, l. 41).
Claim 6. Siebrandt discloses wherein the first angle and the second angle are approximately alternate angles (see Fig. 1, which shows that the curvatures of upper jaw 12 and lower jaw 14 are mirror images) (Figs. 1-3; pg. 1, col. 2, l. 26 through pg. 2, col. 2, l. 41).
Claim 7. Siebrandt discloses wherein the tamp includes a serrated edge (defined by serrations 15) having multiple projections (serrations 15) extending from the distal end of the second elongated member (Figs. 1-3; pg. 1, col. 2, l. 26 through pg. 2, col. 2, l. 41).
Claim 22. Siebrandt discloses wherein the handle is substantially linear (see Fig. 1, which shows that, when squeezed together, handle portions 10 and 11 form a substantially linear shape – contrast this with Fig. 4, which shows handle portion 10 separated from handle portion 11 at rod 40) (Figs. 1-3; pg. 1, col. 2, l. 26 through pg. 2, col. 2, l. 41).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Krauss et al. (US 2017/0209192 A1) in view of Turner et al. (US 2011/0257657 A1).
Claim 14. Krauss discloses a kit (see para. 0045), comprising: the bone fragment manipulation device of claim 1 (see the rejection of claim 1 above) (Figs. 1-7B; paras. 0027-0053).
Claim 15. Krauss discloses a guiding member (guide 120) configured to be fixedly retained within a cavity of the second elongated member extending from the opening to the distal end of the second elongated member, the guiding member having a sidewall extending from a first end (end adjacent opening 124) to a second end (end adjacent second end portion 56 of support/guide member 50 as shown in Fig. 7B) and defining a first cavity (see Fig. 7B, which shows a cavity through guide 120) configured to retain the k-wire (the cavity can receive a k-wire in the same manner as drill bit 130 as shown in Figs. 7A-7B) (Figs. 1-7B; paras. 0027-0053).
Krauss fails to disclose that the kit also comprises at least one k-wire (claim 14).
However, Krauss discloses that the opening in the second tool component and the cavity in the guiding member are configured to receive and retain a drill (drill bit 130) (Figs. 1-7B; paras. 0027-0053).
Turner teaches that a drill is cannulated such that it receives a k-wire, wherein such a configuration allows the surgeon to position the k-wire and verify its position prior to drilling the bone (see para. 0003).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of Krauss such that it also comprises at least one k-wire (claim 14) and the drill is cannulated to receive the k-wire, as suggested by Turner, as such would allow the surgeon to position the k-wire and verify its position prior to drilling the bone, thereby reducing the possibility of erroneously drilling at an incorrect location or angle.
Response to Arguments
Applicant's arguments filed March 25, 2026 have been fully considered but they are not persuasive.
Applicant argues that Krauss and Siebrandt fail to teach a device in which the first and second members are attached to opposing ends of the handle (see pg. 8 regarding Krauss; see pg. 10 regarding Siebrandt). The Examiner disagrees. Claim 1 does not recite a direct attachment as seemingly inferred by Applicant as being required by the claim. Instead, the claim merely recites that opposing ends of the handle are connected to the first and second members. As explained in the rejections above, one end of the handle is connected to one of the first and second members via a direct connection and the other end of the handle is connected to the other of the first and second members via an indirect connection.
Applicant also argues that Krauss fails to teach an opening configured to receive a k-wire because Krauss fails to disclose an internals structure configured to support the lateral stability of a k-wire (see pgs. 8-9). The Examiner disagrees. An opening configured to receive a k-wire must merely be large enough for a k-wire to pass through the opening. Claim 1 does not include any functional or structural limitations regarding supporting lateral stability of a k-wire.
Applicant also argues that Siebrandt does not include a tamp because serrations are not a tamp (see pg. 10). The Examiner disagrees. The Examiner did not identify the serrations as the tamp, but the surface with the serrations as the tamp. Furthermore, regarding the functional use of the tamp as stated by Applicant (see Fig. 10), the Examiner notes that the aforementioned surface of Siebrandt is capable of functioning in such a manner.
Applicant’s arguments regarding Turner and the handle limitations (see pgs. 11-12) are moot as Turner was not relied upon to teach any limitations of the handle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tam (US 4,622,960 A), Huebner (US 2005/0085723 A1), Ryshkus (US 2015/0196289 A1), Baertich (US 2017/0079704 A1), and Zheng (US 11,317,902 B2) all disclose a device wherein a handle has one end directly connected to a proximal end of a first tool and the other end directly connected to a proximal end of a second tool (see Fig. 1 of Tam; see Fig. 2 of Huebner; see Fig. 16 of Ryshkus; see Fig. 8 of Baertich; and see Fig. 1 of Zheng).
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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm 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.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773