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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 17, 2025 has been entered.
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 54-57 are 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 54 recites the limitation "the oblique tip" in line 5. There is insufficient antecedent basis for this limitation in the claim as claim 43 has been amended to recite “the tapered tip” instead of “the oblique tip.” Claims 55-57 depend from claim 54 and are therefore also rejected. Amending claim 54 to recite “the tapered tip” instead of “the oblique tip” would overcome this rejection.
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.
Claims 43-52 are rejected under 35 U.S.C. 103 as being unpatentable over Kuldjanov et al. (US 2015/0282935 A1) in view of Podolsky et al. (US 2014/0074250 A1).
Claim 43. Kuldjanov discloses an orthopedic implantable device (intramedullary device 10) for treatment of periprosthetic bone fractures, the device comprising an elongated cylindrical shaft (see Fig. 2) extending between a distal end (distal end 20) and a proximal end (proximal end 18) and having a longitudinal axis (extends along line 3-3 as shown in Fig. 2), wherein the device is configured to be inserted within the medullary cavity of a femur, wherein a proximal portion (portion with slots 30) of the device extends from the proximal end, the proximal portion being sized and shaped to allow radial engagement with a distal tip of a preexisting hip prosthesis (see Fig. 1) through a friction fit (see para. 0033, which states that fingers 32 engage and capture distal end 34 of hip stem 14; note that, in order for fingers 32 to capture distal end 34, they must exert a force against hip stem 14, and because distal end 34 is tapered as shown in Fig. 2, it is clear that this force must be a frictional force as distal end 34 does not include any structural features for engagement with fingers 32) (Figs. 1-3; paras. 0025-0034).
Claim 45. Kuldjanov discloses wherein at least said proximal portion being hollowed (center bore 24) (Figs. 1-3; paras. 0025-0034).
Claim 47. Kuldjanov discloses at least one longitudinal slot (slot 30) extending from said proximal end and allowing said engagement with said preexisting hip prosthesis in a radial expandable manner (Figs. 1-3; paras. 0025-0034).
Claim 48. Kuldjanov discloses wherein the slot has a substantially U-like, or V-like shape (see Fig. 3, which shows that the lower end of slot 30 is rounded, and thus slot 30 forms an elongated U-like shape) (Figs. 1-3; paras. 0025-0034).
Claim 49. Kuldjanov discloses wherein said proximal portion is expandable (due to the presence of slots 30) allowing adaptation thereof to various sizes and/or shapes of said distal tip of the preexisting hip prosthesis (Figs. 1-3; paras. 0025-0034).
Claim 50. Kuldjanov discloses wherein said proximal portion has a rounded (see Fig. 2, which shows that the cross-section at the proximal portion is rounded), or an elliptical cross section (Figs. 1-3; paras. 0025-0034).
Claim 51. Kuldjanov discloses a distal portion (portion with threaded portion 38) extending from said distal end, the distal portion being internally threaded (threaded portion 38) allowing manipulation of the shaft within a bone by a tool comprising a body with complementary external threaded proximal end (Figs. 1-3; paras. 0025-0034).
Kuldjanov fails to disclose wherein said elongated cylindrical shaft is oblique relative to a vertical axis of said proximal end, thereby forming a tapered tip, wherein said device is configured for positioning such that a long end of said longitudinal axis of the tapered tip is disposed at a medial side of the femur (claim 43), wherein the proximal portion having a conical shape wherein the outer and/or inner diameter decreases in a proximal to distal direction (claim 44), wherein an angle of less than about 90º extends between a longitudinal axis and a vertical axis of the shaft at said proximal end (claim 46), and wherein the slot has a length within the range from about 30 mm to about 170 mm, and/or the slot has a maximal width within the range of about 5 mm to about 20 mm (claim 52).
Podolsky teaches an orthopedic implantable device (sleeve 5400) comprising a shaft (see Fig. 126 inset) having a longitudinal axis (see Fig. 126 inset) and extending between a proximal portion (see Fig. 126 inset) at a proximal end (see Fig. 126 inset) and a distal end (see Fig. 126 inset), the shaft is oblique relative to a vertical axis of said proximal end, thereby forming a tapered tip (see Fig. 126 inset), wherein said device is configured for positioning such that a long end of said longitudinal axis of the tapered tip is disposed at a medial side (side facing femoral head implant component 5300) of a femur, wherein the proximal portion has a conical shape (see Fig. 126 inset) wherein the outer and/or inner diameter decreases in a proximal to distal direction, and wherein an angle of less than about 90º extends between the longitudinal axis and the vertical axis of the shaft at said proximal end (due to the conical shape), wherein the shape of the proximal portion is complementary to the position of a hip prosthesis (femoral neck implant component 5200 and femoral head implant component 5300) (Figs. 125-128).
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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 device of Kuldjanov such that said elongated cylindrical shaft is oblique relative to a vertical axis of said proximal end, thereby forming a tapered tip, wherein said device is configured for positioning such that a long end of said longitudinal axis of the tapered tip is disposed at a medial side of the femur (claim 43), the proximal portion has a conical shape wherein the outer and/or inner diameter decreases in a proximal to distal direction (claim 44), and an angle of less than about 90º extends between a longitudinal axis and a vertical axis of the shaft at said proximal end (claim 46), as suggested by Podolsky, as such a shape of the proximal portion is complementary to the position of a hip prosthesis and may thereby provide additional structural support to the hip prosthesis. 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 device of Kuldjanov such that the slot has a length within the range from about 30 mm to about 170 mm, and/or the slot has a maximal width within the range of about 5 mm to about 20 mm (claim 52) since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Kuldjanov et al. (US 2015/0282935 A1) in view of Podolsky et al. (US 2014/0074250 A1), Lindvall (US 8,668,692 B1), and Nelson et al. (US 2011/0270256 A1).
Claim 58. Kuldjanov and Podolsky teach an orthopedic implantable device according to claim 43 (intramedullary device 10 of Kuldjanov as modified by Podolsky; see the rejection of claim 43 above) (Figs. 1-3 and paras. 0025-0034 of Kuldjanov; Figs. 125-128 of Podolsky).
Kuldjanov and Podolsky fail to teach a kit for treatment of periprosthetic bone fractures, the kit comprising the orthopedic implantable device and a spatula configured for removing a tissue material from the vicinity of a preexisting bone implant prior to an insertion of the orthopedic implantable device (claim 58), a nail extender configured to engage with a distal end of the orthopedic implantable device and elongate a length thereof within a bone canal (claim 59), wherein the nail extender includes a connection bolt allowing to secure a connection between the distal end of the orthopedic implantable device and the proximal end of the nail extender, and wherein the distal end of the orthopedic implantable device is internally threaded and the bolt configured to engage with the internal thread of the orthopedic implantable device (claim 60).
Lindvall teaches a kit (see col. 12, ll. 14-20) comprising: an orthopedic implantable device (linkage device 210) configured to engage a preexisting hip prosthesis (femoral stem 68), wherein the orthopedic implantable device is expanded using a nail extender (nail 140), the nail extender configured to engage with a distal end (end adjacent nail 140) of the orthopedic implantable device along a length thereof, wherein the nail extender includes a connection bolt (threaded end of nail 410; see col. 6, ll. 24-34) allowing to secure the connection between the distal end of the orthopedic implantable device and the proximal end of the nail extender (see col. 6, ll. 24-34), wherein the distal end of the orthopedic implantable device is internally threaded (thread 232) and the bolt configured to engage with the internal thread of the orthopedic implantable device (see col. 6, ll. 24-34), and wherein the components of the kit may be provided pre-sterilized and in individual packaging (see col. 12, ll. 14-20) (Figs. 5A-6; col. 2, l. 60 through col. 3, l. 10; col. 6, ll. 24-34; col. 12, ll. 14-20).
Nelson teaches a spatula (rasp system 100; note that rasp head 108 is in the shape of a spatula) configured for removing bone tissue material (see para. 0069), wherein the configuration of the spatula is particularly suited for removing bone tissue (see para. 0069) (Figs. 1A-4A; para. 0069).
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 device by providing the components in a kit (claim 58), as suggested by Lindvall, as the components of such a kit may be provided pre-sterilized and in individual packaging. 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 by providing a spatula configured for removing a tissue material from the vicinity of a preexisting bone implant prior to an insertion of the orthopedic implantable device (claim 58), as suggested by Nelson, as such an instrument can be particularly suited for removing bone tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the kit by providing a nail extender configured to engage with a distal end of the orthopedic implantable device and elongate a length thereof within a bone canal (claim 59), wherein the nail extender includes a connection bolt allowing to secure a connection between the distal end of the orthopedic implantable device and the proximal end of the nail extender, and wherein the distal end of the orthopedic implantable device is internally threaded and the bolt configured to engage with the internal thread of the orthopedic implantable device (claim 60), as suggested by Lindvall, as the use of an extender can allow the device to be customized to accommodate patients with differing lengths of the femur.
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Kuldjanov et al. (US 2015/0282935 A1) in view of Podolsky et al. (US 2014/0074250 A1), Lindvall (US 8,668,692 B1), and Nelson et al. (US 2011/0270256 A1) as applied to claim 58 above, and further in view of Yoon et al. (US 2013/0197551 A1).
Claim 61. Kuldjanov, Podolsky, Lindvall, and Nelson teach the kit and Nelson teaches wherein the spatula comprises a handle (handle portion 106) and a bowl (rasp head 108) coupled to said handle, said spatula sized and shaped to allow insertion thereof within a bone cavity (Figs. 1A-4A; para. 0069).
Kuldjanov, Podolsky, Lindvall, and Nelson fail to teach wherein said handle comprises a slight curvature to conform to a bow within said bone (claim 61).
Yoon teaches a tissue removal tool (tissue removal device 100) comprising a handle (handle 140) and a tissue removal portion (tip 120) coupled to the handle, wherein the handle comprises a slight curvature (see Fig. 1, which shows that the portion of handle 140 adjacent shaft 110 is offset from the free end of handle 140) (Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the kit such that said handle comprises a slight curvature to conform to a bow within said bone (claim 61), as suggested by Yoon, as such an offset handle configuration would allow for better visibility during use.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Kuldjanov et al. (US 2015/0282935 A1) in view of Podolsky et al. (US 2014/0074250 A1), Lindvall (US 8,668,692 B1), Nelson et al. (US 2011/0270256 A1), and Yoon et al. (US 2013/0197551 A1) as applied to claim 61 above, and further in view of Choi et al. (US 2017/0071588 A1).
Kuldjanov, Podolsky, Lindvall, Nelson, and Yoon fail to teach wherein said spatula further comprising a T-junction at an end of the handle, the T-junction comprises side wings extending from the T-junction (claim 62).
Choi teaches a handle configuration, wherein the handle (handle 210) comprises a T-junction at an end of the handle (see Fig. 13), wherein the T-junction comprises side wings (end portions 303 and 304) extending from the T-junction such that a user can comfortably grip the handle (see para. 0065) (Fig. 13; para. 0065).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the kit such that said spatula further comprising a T-junction at an end of the handle, the T-junction comprises side wings extending from the T-junction (claim 62), as suggested by Choi, in order to allow a user to comfortably grip the handle.
Allowable Subject Matter
Claims 54-57 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 and if amended as suggested above to overcome the 35 U.S.C. 112 rejection.
Response to Amendment
The declaration under 37 CFR 1.132 filed February 13, 2026 is insufficient to overcome the rejection of claim 43 based upon Kuldjanov in view of Podolsky as set forth in the last Office action. Regarding Kuldjanov and the friction fit (see pg. 2), see the Response to Arguments below. Regarding the combination of Podolsky with Kuldjanov (see pgs. 2-3), it is noted that claim 43 is an apparatus claim, and not a method claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the structure of the prior art is capable of functioning as claimed.
The declaration under 37 CFR 1.132 filed February 13, 2026 is sufficient to overcome the rejection of claim 54 based upon Kuldjanov in view of Podolsky and Lindvall.
Response to Arguments
Applicant's arguments filed February 13, 2026 have been fully considered but they are not persuasive.
Applicant argues that Kuldjanov does not create a passive friction fit but an active capture (see pg. 8). The Examiner disagrees. First of all, the claims do not recite a so-called “passive” friction fit, but merely a friction fit. Furthermore, the claims cannot be amended to recite a “passive friction fit” as such is not present in the specification as originally filed. In addition, as stated in the rejection above, in order for fingers 32 to capture distal end 34, they must exert a force against hip stem 14, and because distal end 34 is tapered as shown in Fig. 2, it is clear that this force must be a frictional force as distal end 34 does not include any structural features for engagement with fingers 32. Thus, the engagement between fingers 32 and distal end 34 of Kuldjanov is clearly a friction fit. Also, it is noted that Applicant’s own device is similar to Kuldjanov in that the proximal portion includes a split to allow for expansion while engaging the hip prosthesis. Therefore, the Examiner is taking the position that, if Applicant’s device provides a friction fit engagement, so does the device of Kuldjanov.
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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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