Prosecution Insights
Last updated: May 29, 2026
Application No. 18/720,758

OSTEOSYNTHESIS IMPLEMENT, OSTEOSYNTHESIS SET, AND OSTEOSYNTHESIS MEMBER SET

Non-Final OA §102§103§112
Filed
Jun 17, 2024
Priority
Dec 22, 2021 — JP 2021-208193 +1 more
Examiner
LITTLE, ANNA VICTORIA
Art Unit
3773
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Hoya Technosurgical Corporation
OA Round
1 (Non-Final)
76%
Grant Probability
Favorable
1-2
OA Rounds
7m
Est. Remaining
98%
With Interview

Examiner Intelligence

Grants 76% — above average
76%
Career Allowance Rate
79 granted / 104 resolved
+6.0% vs TC avg
Strong +22% interview lift
Without
With
+22.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
12 currently pending
Career history
123
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
70.8%
+30.8% vs TC avg
§102
10.0%
-30.0% vs TC avg
§112
17.4%
-22.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 104 resolved cases

Office Action

§102 §103 §112
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 . Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “intramedullary nail aid” (recited in Claim 16) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. It is noted that the specification recites “the osteosynthesis implement 100 in the present embodiment includes […] an intramedullary aid 10” where the intramedullary nail aid “is selectively attachable to, for example, a conventionally known intramedullary nail 101” (in paragraph 0019, with respect to Fig. 1A). While Fig. 1A does include the reference numeral “10”, it is unclear if the lead arrow associated with the reference numeral points to any particular feature or structure. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 16 recites an osteosynthesis implement comprising “an intramedullary nail aid” (at line 4), where it is generally unclear which structure(s) and/of feature(s) define such an aid. It is noted that the specification recites “the osteosynthesis implement 100 in the present embodiment includes […] an intramedullary aid 10” where the intramedullary nail aid “is selectively attachable to, for example, a conventionally known intramedullary nail 101” (in paragraph 0019, with respect to Fig. 1A). While Fig. 1A does include the reference numeral “10”, it is unclear if the lead arrow associated with the reference numeral points to any particular feature or structure. 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, 5-6, 10-11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Russell (US 2014/0031791 A1). Regarding claim 1, Russell teaches an osteosynthesis member (bone screw 1; Figs. 1A-2B; para. 0095) to be inserted into an intramedullary nail (screw 1 in Figs. 1A-2B is capable of being inserted into an intramedullary nail, such as transversely inserted into a femoral nail through the femoral neck, where at least para. 0021-0022, and claim 37, teach the device being used in a femur or pelvis), the osteosynthesis member including a shaft portion (threaded screw body 2 and screw head 3, collectively; Fig. 1A; para. 0095), and a screw engagement portion (2; Fig. 1A) formed so that a plurality of unit screw threads, provided around a circumferential surface of the shaft portion, are continuous in a spiral shape (as shown; Figs. 1A-2B), the osteosynthesis member comprising: a shaft hole (interior channel 4; Figs. 1A, 2A; para. 0095) extending in an axial direction inside the shaft portion; a missing portion (10; Fig. 1A; para. 0096) formed by removing part of a specific unit screw thread so that internal spaces of a pair of screw grooves, adjacent across the specific unit screw thread, face each other (as shown in Figs. 1A-2B, the missing portion defined by exterior groove 10 is formed by removing part of specific screw threads on the threaded screw body 2; para. 0096); and a hole portion (defined by one or more radially-disposed delivery channels 5; Fig. 1A; para. 0095) that is opened so that each screw groove of the pair of screw grooves in a vicinity of the missing portion communicates with the shaft hole (via corresponding exterior openings 6 of delivery channels 5; Figs. 1A-2B; para. 0095). Regarding claim 5, Russell teaches the osteosynthesis member according to claim 1, wherein the missing portion (10; Fig. 1A) and the hole portion (5; Fig. 1A) are provided in a plurality of places in a circumference direction of the shaft portion (while one missing portion/groove 10 is shown in the view of Fig. 1A, para. 0096 describes the screw body 2 containing three exterior grooves substantially equally spaced around the screw body and connecting exterior openings 6 of hole portions 5, so that the missing portion 10 and hole portion 5 are provided at a plurality of circumferential places on the screw body 2 of the shaft portion). Regarding claim 6, Russell teaches the osteosynthesis member according to claim 1, wherein the missing portion (10; Fig. 1A) and the hole portion (5; Fig. 1A) are provided in four places at approximately equal intervals around an axis of the shaft portion (while one missing portion/groove 10 is shown in the view of Fig. 1A, para. 0096 describes the screw body 2 containing “three exterior grooves substantially equally spaced around the screw body 2” and optionally “more than three external grooves”, so it is understood that the missing portion 10 and hole portions 5 may be provided in four equally spaced locations around an axis of the screw body 2 of the shaft portion). Regarding claim 10, Russell teaches an osteosynthesis member set, comprising: the osteosynthesis member (bone screw 1; Figs. 1A-2B) according to claim 1 (as described above); and an injector configured to allow injection of an intraosseous injection agent into a bone, wherein the injector includes an injection nozzle configured to be insertable into the shaft hole, and a single injection port provided so as to correspond to the hole portion at a tip of the injection nozzle (para. 0103 and 0118 describe using a syringe, i.e. injector, depicted in Fig. 7F, to introduce bone cement through a delivery manifold 19, shown in Fig. 7A, into the bone screw 1 and thus into a bone, where a syringe injector is understood to include a nozzle at its tip that is capable of being inserted into the shaft hole 4 of bone screw 1 and a single injection port provided as an opening at the tip of the nozzle, the injection port understood to correspond to the hole portion 5; Figs. 1A-2B; para. 0054). Regarding claim 11, Russell teaches an osteosynthesis member set, comprising: an osteosynthesis member (bone screw 1; Figs. 1A-2B; para. 0095) to be inserted into an intramedullary nail (screw 1 in Figs. 1A-2B is capable of being inserted into an intramedullary nail, such as transversely inserted into a femoral nail through the femoral neck, where at least para. 0021-0022, and claim 37, teach the device being used in a femur or pelvis), the osteosynthesis member including a shaft portion (threaded screw body 2 and screw head 3, collectively; Fig. 1A; para. 0095), a screw thread (7; Fig. 1A; para. 0095) provided spirally around a circumferential surface of the shaft portion (as shown; Figs. 1A-2B), and a shaft hole (interior channel 4; Figs. 1A, 2A; para. 0095) extending in an axial direction inside the shaft portion (see Figs. 1A, 2A); and an injector configured to allow injection of an intraosseous injection agent into a bone (though not depicted in the drawings, para. 0103 describes using a syringe, i.e. injector, to introduce bone cement through a delivery manifold 19, shown in Fig. 7A, into the bone screw 1 and thus into a bone; Figs. 1A-2B), wherein: the osteosynthesis member (1; Figs. 1A-2B) includes a missing portion (10; Fig. 1A; para. 0096) provided in a unit screw thread so that internal spaces of a pair of screw grooves, adjacent across the unit screw thread, face each other, the unit screw thread corresponding to one round of 360 degrees of the screw thread (as shown in Figs. 1A-2B, the missing portion defined by exterior groove 10 is provided through several unit screw threads so that internal spaces of an adjacent pair of screw grooves face each other; para. 0096), a hole portion (defined by one or more radially-disposed delivery channels 5; Fig. 1A; para. 0095) provided in the shaft portion so as to communicate with the missing portion (via corresponding exterior openings 6 of delivery channels 5; Figs. 1A-2B; para. 0095), and an osteosynthesis member-side positioning portion (defined by screw head 3; Figs. 1A, 7A-B; para. 0095, 0101); the injector includes an injection nozzle configured to be insertable into the shaft hole of the osteosynthesis member, a single injection port provided at a tip portion of the injection nozzle (where the injector is a syringe as described above, shown in Fig. 7F, it is understood to include an injection nozzle at a tip thereof capable of being insertable into the shaft hole/bore 4 of bone screw 1 and a single injection port provided as an opening at the tip of the nozzle and a single injection port provided as an opening at the tip of the nozzle; Figs. 1A-2B; para. 0054, 0103), and an injector-side positioning portion (defined by delivery manifold 19; Figs. 7A, 7F; para. 0103); and the osteosynthesis member-side positioning portion (screw head 3; Figs. 1A, 7A) and the injector-side positioning portion (delivery manifold 19; Fig. 7A) are used to position the injector with respect to the osteosynthesis member to allow the injection port to correspond to the hole portion (as shown; Figs. 7A, 7F; para. 0103). Regarding claim 14, Russell teaches the osteosynthesis member set according to claim 11, wherein: the osteosynthesis member (1; Figs. 1A-2B) includes, at a base end portion of the shaft portion, an engagement recess portion (hexagonal opening 9 at screw head 3, i.e. base end of shaft portion; Fig. 2A-B; para. 0096) that is fitted with an instrument that rotates the osteosynthesis member (as shown in Figs. 7A-B, fitted with hexagonal end 23 of a driver instrument 22 to rotate bone screw 1; para. 0102); and the engagement recess portion functions as the osteosynthesis member-side positioning portion (engagement recess portion 9, in conjunction with external thread 8 of the screw head 3, function as the osteosynthesis member-side positioning portion for aligning delivery manifold 19 and the syringe injector; Figs. 7A-F). Claims 1, 9 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann (US 2004/0122431 A1). Regarding claim 1, Biedermann teaches an osteosynthesis member (1; Figs. 1-2; para. 0024-0031) to be inserted into an intramedullary nail (91; Fig. 4; para. 0037), the osteosynthesis member including a shaft portion (defined by thread section 2 and holding element 4, collectively; Figs. 1, 4; para. 0011) and a screw engagement portion (defined by thread 22 on thread section 2; Fig. 1) formed so that a plurality of unit screw threads, provided around a circumferential surface of the shaft portion, are continuous in a spiral shape (as shown; Figs. 1-2), the osteosynthesis member comprising: a shaft hole (bore of tubular threaded section 2; Fig. 1; para. 0011; Abstract) extending in an axial direction inside the shaft portion (see Figs. 1-2); a missing portion formed by removing part of a specific unit screw thread so that internal spaces of a pair of screw grooves, adjacent across the specific unit screw thread, face each other (recesses 21 formed throughout threaded section 2, for allowing bone cement to exit from the shaft hole/bore of section 2, are shown to form missing portions in specific screw threads 22 in the claimed manner; Figs. 1-2; para. 0024, 0034-0035); and a hole portion that is opened so that each screw groove of the pair of screw grooves in a vicinity of the missing portion communicates with the shaft hole (recesses 21 formed in the threads 22 define hole portions opening so that the pairs of screw grooves, adjacent each screw thread 22, communicate with the shaft hole/bore of tubular threaded section 2; Figs. 1-2; para. 0034-0035). Regarding claim 9, Biedermann teaches an osteosynthesis member (1; Figs. 1-2; para. 0024-0031) to be inserted into an intramedullary nail (91; Fig. 4; para. 0037), the osteosynthesis member including a shaft portion (defined by thread section 2 and holding element 4, collectively; Figs. 1, 4; para. 0011) having a shaft hole (bore of tubular threaded section 2; Fig. 1; para. 0011; Abstract), and a screw thread (22; Fig. 1) provided at a tip of the shaft portion (thread 22 shown provided at a lower end, i.e. tip, of thread section 2of the shaft portion defined above; Fig. 1), wherein: the shaft portion includes a hole portion (21; Fig. 1; para. 0024) of an elongated shape extending in a direction approximately parallel to a length direction of the shaft portion (at least one of recesses 21 for delivering bone cement through section 2 of the shaft portion defines a hole portion, the recesses/hole portions being diamond-shaped and oriented so as to extend in a longitudinal length direction of the shaft portion 2, as described in para. 0024; Fig. 1); and the hole portion penetrates from a surface of the shaft portion to the shaft hole (where hole portion(s) 21 are provided to allow bone cement or growth-promoting agent to exit from the shaft hole/bore of threaded section 2, the hole portion penetrates from an exterior surface of the shaft portion to the shaft hole/bore; Figs. 1-4; para. 0034). Regarding claim 16, Biedermann teaches an osteosynthesis implement (fixation device 90; Fig. 4; para. 0037), comprising: the osteosynthesis member according to claim 1 (shown comprising the bone screw member 1 according to claim 1, including shaft sections 2 and 4; Figs. 1-2 and 4; para. 0037); and an intramedullary nail (marrow nail 91; Fig. 4; para. 0037), and an intramedullary nail aid (defined by closure screw 93; Fig. 4; para. 0037). 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. 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 2-4, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Russell (US 2014/0031791 A1), as applied to claim 1 above, further in view of Takeuchi (JP 3575208 B2). Note that the following parenthetical citations to Takeuchi are taken from the English language translation provided with this Office Action. Regarding claims 2-3, Russell teaches the osteosynthesis member according to claim 1. Russell does not disclose [Claim 2] wherein the hole portion includes a long hole region formed so as to extend across both screw grooves in the pair thereof; and [Claim 3] wherein the long hole region extends in a direction that is approximately parallel to a length direction of the shaft portion. Takeuchi, in analogous art, teaches an osteosynthesis member in the form of a bone screw (see Figs. 1-4) capable for use with an intramedullary nail, such as a femoral nail (as evidenced by Figs. 5-8 showing the bone screw device being inserted in a femoral neck and head), the osteosynthesis member including a shaft portion and a plurality of screw threads provided around a circumferential surface of the shaft portion (see Figs. 1-4, showing a shaft portion with screw portion 2 comprising ridges 2b and valleys 2a). In one embodiment (see Fig. 4, with through holes 6b), Takeuchi discloses wherein the osteosynthesis member has a missing portion formed by removing part of a screw thread and a hole portion communicating with a shaft hole extending through the osteosynthesis member and opening so that screw grooves in a vicinity of the missing portion communicate with the shaft hole (as shown in Fig. 4 and described in at least para. 0014 and 0017-0018, through holes 6b are formed in the valleys 2a and the ridges 2b of the screw thread portion 2, thus defining a missing portion and a hole portion communicating with a shaft hole 5, depicted in the analogous embodiment of Fig. 1). In this embodiment (Fig. 4), Takeuchi teaches [Claim 2] wherein the hole portion includes a long hole region formed so as to extend across both screw grooves in the pair thereof (as shown in Fig. 4, the hole portion defined by the identified lower through holes 6b includes a long hole region extending across at least two screw grooves in an adjacent pair thereof; para. 0014); and [Claim 3] wherein the long hole region extends in a direction that is approximately parallel to a length direction of the shaft portion (see through holes 6b identified in Fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Russell’s missing portion (in the form of an external groove) and the hole portion (provided as a plurality of holes communicating with the missing portion groove) to take the form of Takeuchi’s hole portion, such that the hole portion includes the claimed long hole region extending in a length direction of the shaft, because Takeuchi recognizes that such a shape and configuration is suitable for an osteosynthesis member in the form of a bone screw for delivering bone cement through the shaft hole of the screw and to the bone to be treated (see Takeuchi, Figs. 4-8, para. 0017-0018). Regarding claim 4, Russell teaches the osteosynthesis member according to claim 1. Russell does not disclose wherein the unit screw threads adjacent to the specific unit screw thread do not have a missing region facing the missing portion of the specific unit screw thread. Takeuchi, in analogous art, teaches an osteosynthesis member in the form of a bone screw (see Figs. 1-4) capable for use with an intramedullary nail, such as a femoral nail (as evidenced by Figs. 5-8 showing the bone screw device being inserted in a femoral neck and head), the osteosynthesis member including a shaft portion and a plurality of screw threads provided around a circumferential surface of the shaft portion (see Figs. 1-4, showing a shaft portion with screw portion 2 comprising ridges 2b and valleys 2a). In one embodiment (see Fig. 4, with through holes 6b), Takeuchi discloses wherein the osteosynthesis member has a missing portion formed by removing part of a screw thread and a hole portion communicating with a shaft hole extending through the osteosynthesis member and opening so that screw grooves in a vicinity of the missing portion communicate with the shaft hole (as shown in Fig. 4 and described in at least para. 0014 and 0017-0018, through holes 6b are formed in the valleys 2a and the ridges 2b of the screw thread portion 2, thus defining a missing portion and a hole portion communicating with a shaft hole 5, depicted in the analogous embodiment of Fig. 1). In this embodiment (Fig. 4), Takeuchi teaches wherein the unit screw threads adjacent to the specific unit screw thread do not have a missing region facing the missing portion of the specific unit screw thread (as shown with the uppermost, un-labeled through hole 6b in Fig. 4, the missing region of threads/ridges 6b does not extend beyond a single screw thread, i.e. the adjacent unit screw threads do not have a missing region). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Russell’s missing portion (in the form of an external groove) and the hole portion (provided as a plurality of holes communicating with the missing portion groove) to take the form of Takeuchi’s hole portion, such that screw threads adjacent the unit screw thread having a missing region do not have a missing region, as claimed, because Takeuchi recognizes that such a shape and configuration is suitable for an osteosynthesis member in the form of a bone screw for delivering bone cement through the shaft hole of the screw and to the bone to be treated (see Takeuchi, Figs. 4-8, para. 0017-0018). Regarding claim 7, Russell teaches the osteosynthesis member according to claim 1. Russell does not disclose wherein the missing portion and the hole portion are not provided in unit screw threads other than the specific unit screw thread. Takeuchi, in analogous art, teaches an osteosynthesis member in the form of a bone screw (see Figs. 1-4) capable for use with an intramedullary nail, such as a femoral nail (as evidenced by Figs. 5-8 showing the bone screw device being inserted in a femoral neck and head), the osteosynthesis member including a shaft portion and a plurality of screw threads provided around a circumferential surface of the shaft portion (see Figs. 1-4, showing a shaft portion with screw portion 2 comprising ridges 2b and valleys 2a). In one embodiment (see Fig. 4, with through holes 6b), Takeuchi discloses wherein the osteosynthesis member has a missing portion formed by removing part of a screw thread and a hole portion communicating with a shaft hole extending through the osteosynthesis member and opening so that screw grooves in a vicinity of the missing portion communicate with the shaft hole (as shown in Fig. 4 and described in at least para. 0014 and 0017-0018, through holes 6b are formed in the valleys 2a and the ridges 2b of the screw thread portion 2, thus defining a missing portion and a hole portion communicating with a shaft hole 5, depicted in the analogous embodiment of Fig. 1). In this embodiment (Fig. 4), Takeuchi teaches wherein the missing portion and the hole portion are not provided in unit screw threads other than the specific unit screw thread (as shown with the uppermost, un-labeled through hole 6b in Fig. 4 defining the missing portion and the hole portion, the screw threads above or below the particular thread 2b with a missing region do not have a missing region that faces the missing portion of the uppermost through hole). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Russell’s missing portion (in the form of an external groove) and the hole portion (provided as a plurality of holes communicating with the missing portion groove) to take the form of Takeuchi’s hole portion, such that the missing portion and hole portion are not provided in other unit screw threads as claimed, because Takeuchi recognizes that such a shape and configuration is suitable for an osteosynthesis member in the form of a bone screw for delivering bone cement through the shaft hole of the screw and to the bone to be treated (see Takeuchi, Figs. 4-8, para. 0017-0018). Regarding claim 8, Russell teaches the osteosynthesis member according to claim 1. Russell does not disclose wherein the missing portion does not extend across two or more of the unit screw threads. Takeuchi, in analogous art, teaches an osteosynthesis member in the form of a bone screw (see Figs. 1-4) capable for use with an intramedullary nail, such as a femoral nail (as evidenced by Figs. 5-8 showing the bone screw device being inserted in a femoral neck and head), the osteosynthesis member including a shaft portion and a plurality of screw threads provided around a circumferential surface of the shaft portion (see Figs. 1-4, showing a shaft portion with screw portion 2 comprising ridges 2b and valleys 2a). In one embodiment (see Fig. 4, with through holes 6b), Takeuchi discloses wherein the osteosynthesis member has a missing portion formed by removing part of a screw thread and a hole portion communicating with a shaft hole extending through the osteosynthesis member and opening so that screw grooves in a vicinity of the missing portion communicate with the shaft hole (as shown in Fig. 4 and described in at least para. 0014 and 0017-0018, through holes 6b are formed in the valleys 2a and the ridges 2b of the screw thread portion 2, thus defining a missing portion and a hole portion communicating with a shaft hole 5, depicted in the analogous embodiment of Fig. 1). In this embodiment (Fig. 4), Takeuchi teaches wherein the missing portion does not extend across two or more of the unit screw threads (as shown with the uppermost, un-labeled through hole 6b in Fig. 4 defining the missing portion and the hole portion, the missing portion of the corresponding screw thread/ridge 2b extends across only one of the screw threads). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Russell’s missing portion (in the form of an external groove) and the hole portion (provided as a plurality of holes communicating with the missing portion groove) to take the form of Takeuchi’s hole portion, such that the missing portion does not extend across two or more unit screw threads as claimed, because Takeuchi recognizes that such a shape and configuration is suitable for an osteosynthesis member in the form of a bone screw for delivering bone cement through the shaft hole of the screw and to the bone to be treated (see Takeuchi, Figs. 4-8, para. 0017-0018). Allowable Subject Matter Claims 12-13 and 15 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: Claims 12-13 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and claim 12 depending therefrom. In particular, none of the cited references teach or suggest wherein “the hole portion is provided in a plurality of places in a circumference direction of the shaft portion; and the osteosynthesis member-side positioning portion is provided in a plurality of places corresponding to the hole portions in the circumference direction of the shaft portion” as required by claim 12. Claim 15 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and claim 15 depending therefrom. In particular, none of the cited references teach or suggest “wherein the injection port is a long hole extending in an axial direction of the injection nozzle so as to cover the hole portion” as required by claim 12, particularly in view of the structural limitations described in independent claim 1. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892, including: Wu (CN 209332243 U) and Kim (KR 20190102804 A), each disclosing an osteosynthesis member with a slotted hole portion formed in a threaded section and communicated with an interior shaft hole of the member; and Middleton (US 2003/0083662 A1), Greenhalgh (US 2019/0167326 A1), Tronzo (US 4,653,489 A) and Giancola (US 2013/0144344 A1) each disclosing an injector having a nozzle and injection port for delivering flowable material to an osteosynthesis member having hole portions in communication with a shaft hole. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p 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. /ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
Read full office action

Prosecution Timeline

Jun 17, 2024
Application Filed
Apr 23, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
76%
Grant Probability
98%
With Interview (+22.0%)
2y 6m (~7m remaining)
Median Time to Grant
Low
PTA Risk
Based on 104 resolved cases by this examiner. Grant probability derived from career allowance rate.

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