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 . Claims 1, 8-12, 14-16, and 18, 20-25, and 30-42 are pending and examined below.
Response to Arguments
Applicant’s amendments to the claims have overcome the 112(b) rejection regarding indefiniteness previously set forth in the Non-Final Office Action mailed April 21, 2026.
Applicant’s arguments with respect to claim(s) 1 and 18 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.
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.
Claims 18-25 and 31-42 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 18 recites the limitation " the stem component being divided into the three retractable members by two or more longitudinal slits extending from a leading end of the stem component toward a trailing end of the stem component " in the three retractable members. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation “wherein the first counter-torque feature includes a protrusion extending from the first portion and received within a slit disposed adjacent to the retractable member” in “first portion”. It is unclear if applicant is referring to the first portion of the actuator or if they are referring to the first portion of another part of the invention such as the first counter-torque feature being discussed in this claim. In that case, there is insufficient antecedent basis for this limitation in the claim.
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) 18, 20, 23-24, 30, and 36-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al. US 20130116693 A1, herein referred to as Nelson.
Regarding claim 18, Nelson discloses a prosthesis (Fig 36, 3100’’), comprising: a stem component (Fig 36, center component) sized and configured to be received in an intramedullary canal formed in a bone (Fig 36), the stem component including a retractable member (3108) being divided into the three retractable members by two or more longitudinal slits (Annotated Fig 36 below) extending from a leading end of the stem component toward a trailing end of the stem component (Annotated Fig 3), the three retractable members (at least three of 3108 shown) defining an internal cavity in which an actuator (Figs 31 and 32, 3126/3132) is disposed (cavity from which 3108 move from shown in Fig 36), the actuator configured to move within the internal cavity and move the three retractable members from a first position to a second position (Fig 36, shown to engage along length of prosthesis); and wherein the stem component includes a first counter-torque feature (Fig 36, 3114, grooves; [0287]) configured to resist rotation of at least one of the actuator or the stem component when the actuator is actuated.
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Annotated Fig 36
Regarding claim 20, Nelson discloses wherein the first counter-torque feature includes a surface texture at the trailing end of the stem component (Fig 36, 3114).
Regarding claim 23, Nelson discloses wherein the first counter-torque feature includes a recess ([0284]; teaches bore inside stem) defined by the trailing end of the stem component, the recess sized and configured to receive a projection (3128) that extends from a surface of another component of the prosthesis (Fig 30).
Regarding claim 24, Nelson discloses wherein the first counter-torque feature includes a flat formed at the trailing end of the stem component (Fig 36, 3136) the flat configured to be engaged by a complementary surface of another component of the prosthesis (3112).
Regarding claim 30, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 18, and additionally teaches wherein the trailing end of the stem component includes a second counter-torque feature (Fig 36, 3108, [0292]).
Regarding claim 36, Nelson discloses wherein the actuator includes a body (Fig 32, 3160) having a first portion (nongrooved side) and a second portion (Fig 31, 3132 as referred to as 3160 inner rode portion), the second portion tapering from the first portion and providing a cam surface (Annotated Fig 31 below), the body defining a hole that is at least partially threaded at one end (Nelson [0141]).
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Annotated Fig 31
Regarding claim 37, Nelson discloses wherein the first counter-torque feature includes a protrusion extending from the first portion and received within a slit disposed adjacent to the retractable member (Figs 6a-b).
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.
Claim(s) 1, 8-12, 14-16, 21, 25, and 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson.
Regarding claim 1, Nelson discloses a prosthesis (Fig 36, 3100’’), comprising: a first component (3112) defining a hole (3110 passes through hole) and configured to be attached to a prosthetic joint articulating surface ([0280]; Fig 36, shows articulating end of the ulna); and a second component (3114) configured to be coupled to the first component (Fig 36), the second component including a leading end and a trailing end (see annotated Fig 36 below), and including at least two retractable members (Fig 36, 3108), the second component being divided into the at least two retractable members by one or more longitudinal slits extending from the leading end toward the trailing end (See annotated Fig 36 below ), the at least two retractable members configured to be moved from a first position to a second position intraoperatively [0282]; and an actuator (Figs 31 and 32, 3126/3132) configured to be received in and move along the internal cavity of the second component [0292], the actuator including a first counter-torque feature (Fig 32, 3156) configured to engage the second component (Fig 32, 3160) [0292] and to resist rotation of the actuator when the actuator is engaged by a third component (Fig 32, 3150).
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Annotated Fig 36
But does not explicitly disclose the second component defining an internal cavity.
However, in another embodiment, Nelson teaches wherein the second component defining an internal cavity (Fig 20, 114 shows internal cavity shows internal cavity that could be incorporated with the embodiment of Fig. 36 as shown at 3114).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the base invention of Nelson to incorporate wherein the second component defining an internal cavity as taught and suggested by Nelson in order to allow the cavity to mate with threading engagement of other components ([0270]).
Regarding claim 8, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the trailing end of the second component includes a second counter-torque feature (Fig 36, 3114; [0293]), the second counter-torque feature configured to engage the first component and to resist rotation of the second component when the actuator is engaged by the third component [0243].
Regarding claim 9, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 8, and additionally teaches wherein the second counter-torque feature includes surface texturing (Fig 36, 3114).
Regarding claim 10, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 8.
As applied to claim 8, the embodiment of Nelson focusing on Figure 36 does not explicitly disclose wherein second counter-torque feature includes a protrusion that is configured to be received in a corresponding recess defined by the first component.
However, in another embodiment (Fig 6), Nelson also teaches wherein second counter-torque feature includes a protrusion that is configured to be received in a corresponding recess defined by the first component ([0355] and [0230]; Fig 6, 516; slot 618 protrudes to allow press fitting of other components in prosthesis).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson to incorporate wherein second counter-torque feature includes a protrusion that is configured to be received in a corresponding recess defined by the first component, as taught and suggested by Nelson in order to allow the prosthesis to engage with an axial actuator but prevent the prosthesis from rotating ([0230] and [0235]).
Regarding claim 11, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 8, and additionally teaches wherein the second counter-torque feature includes a flat surface (directly right of 3136 Fig 36) formed on the trailing end of the second component that is configured to engage a corresponding surface on the first component (Fig 36).
Regarding claim 12, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 11, and additionally teaches es wherein the second counter-torque feature includes a recess that is configured to receive a protrusion extending from a surface of the first component (Fig 6b).
Regarding claim 14, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 8, and additionally teaches wherein the first counter- torque feature includes a protrusion (Fig 31, 3142) extending from a head portion of the actuator (Fig 32), the protrusion sized and configured to be received in a slit disposed adjacent to the retractable members.
Regarding claim 15, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein a threaded hole defined by a body of the actuator is a blind hole (Fig 30, 3130; element is along the actuating system).
Regarding claim 16, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 15, and additionally teaches wherein the threaded hole (3176) extends through the body of the actuator (Fig 32, interior of element allows members through), the body defining a second hole that receives a pin (3150) having a length that is greater than a width of the body (Fig 32).
Regarding claim 21, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 18. Yet, Nelson as applied to claim 18, regarding Fig 32, does not explicitly disclose wherein the first counter-torque feature includes a protrusion extending from the actuator and disposed within a slit defined by the stem component.
However, in another embodiment (Fig 6b and 7b), Nelson further teaches wherein the first counter-torque feature includes a protrusion (Fig 7b,618) extending from the actuator and disposed within a slit (Fig 6b, 610) defined by the stem component.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson to incorporate wherein the first counter-torque feature includes a protrusion extending from the actuator and disposed within a slit defined by the stem component, as taught and suggested by Nelson in order to allow the prosthesis to engage with axial actuator but prevent it from rotating ([0230] and [0235]).
Regarding claim 22, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 21. And additionally, Nelson teaches wherein the first counter-torque feature includes a protrusion extending from the trailing end of the stem component (Fig 6b, 612).
Regarding claim 25, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 18, and additionally teaches wherein the actuator includes: a first portion (Fig 34b, 3132); a second portion (3126; [0284]) including a threaded shaft that extends through a hole defined by the trailing end of the stem [0284]. However, Nelson (as applied to Figs 32 and 34b) does not explicitly disclose a third portion disposed between the first portion and the second portion, the third portion including a cam surface.
Additionally, in another embodiment, Nelson teaches third portion (Fig 135h, 10460) disposed between the first portion and the second portion, the third portion including a cam surface [0489].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the base invention of Nelson to incorporate a third portion disposed between the first portion and the second portion, the third portion including a cam surface, as taught and suggested by Nelson in order to act as a deployable anchor to engage the intermedullary canal, as needed in fixing bone fractures ([0489] [0466]).
Regarding claim 38, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 36, and additionally teaches wherein the hole defined by the body of the actuator extends through the body ([0282] teaches apertures for receiving), the body defining a transverse hole in which a pin (Fig 33, 3110) is disposed, the pin having a length that is greater than a width of the body (Fig 34a). However, Nelson (as applied to Figs 32-34) does not explicitly disclose a body such that at least a portion of the pin is received within a slit disposed adjacent to the retractable member.
Additionally, in another embodiment, Nelson (Figs 9-10) also teaches a body such that at least a portion of the pin is received within a slit ([0239] Rectangular apertures) disposed adjacent to the retractable member.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the base invention of Nelson to incorporate such that at least a portion of the pin is received within a slit disposed adjacent to the retractable member, as taught and suggested by Nelson in order to allow cooperation with other members in the system (Nelson [0239]).
Regarding claim 39, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 38, and additionally teaches wherein the first counter-torque feature includes a surface texture (Fig 29, 3114) at the trailing end of the stem component.
Regarding claim 40, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 38, and additionally teaches wherein the first counter-torque feature includes a protrusion (Fig 7a, 122) extending from the trailing end of the stem component (Fig 7a).
Regarding claim 41, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 38, and additionally teaches wherein the first counter-torque feature includes a recess (Fig 6a, 118) defined by the trailing end of the stem component (Fig 6a), the recess sized and configured to receive a projection that extends from a surface of another component of the prosthesis (Fig 6a-b and 7a-b).
Regarding claim 42, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 38, and additionally teaches wherein the first counter-torque feature includes a flat (Fig 6a, 614) formed at the trailing end of the stem component (Fig 6a), the flat configured to be engaged by a complementary surface of another component of the prosthesis (Figs 6a-b and 7a-b).
Claim(s) 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Krebs et al. US 20100198276 A1, herein referred to as Krebs.
Regarding claim 31, Nelson discloses the invention substantially as claimed and as discussed above with respect to claim 18, but does not explicitly disclose wherein the second counter-torque feature includes a surface texture at the trailing end of the stem component.
However, in the same field of invention and endeavor, Krebs teaches a prosthesis (Fig 13, 30e), comprising: a stem component (58e) sized and configured to be received in an intramedullary canal formed in a bone ([0141] and [0183]), the stem component including a retractable member being divided into the three retractable members by two or more longitudinal slits extending from a leading end of the stem component toward a trailing end of the stem component, the three retractable members (Fig 13, 48e); and wherein the second counter-torque (Fig. 13, 216; annotated figure drawing attention to surface texture) feature includes a surface texture at the trailing end of the stem component (Fig 13).
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Annotated Fig 13
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the base invention of Nelson to incorporate wherein the second counter-torque feature includes a surface texture at the trailing end of the stem component, as taught and suggested by Krebs in order to promote tissue growth (Krebs [0142]).
Regarding claim 32, the combination of Nelson and Krebs discloses the invention substantially as claimed and as discussed above with respect to claim 31. However, Nelson (Figs 32-34) as modified by Krebs (Fig 13) as applied to claim 31 but does not explicitly disclose wherein the second counter-torque feature includes a protrusion extending from the actuator and disposed within a slit defined by the stem component.
However, Krebs (Figs 13) also teaches wherein the second counter-torque feature includes a protrusion (Krebs Fig 13, 82e) extending from the actuator (Krebs Fig 5, actuator member 112) and disposed within a slit (Krebs 74) defined by the stem component.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson as modified by Krebs to incorporate wherein the second counter-torque feature includes a protrusion extending from the actuator and disposed within a slit defined by the stem component, as taught and suggested by Krebs in order to engage with telescoping components of the prosthesis (Krebs [0066]).
Regarding claim 33, Nelson as modified by Krebs discloses the invention substantially as claimed and as discussed above with respect to claim 3. However, Nelson (Figs 32-34) as modified by Krebs (Fig 13) as applied to claim 31 does not explicitly disclose wherein the second counter-torque feature includes a protrusion extending from the trailing end of the stem component.
However, Krebs (Figs 3) also teaches wherein the second counter-torque feature includes a protrusion (Krebs Fig 3, 44) extending from the trailing end of the stem component (Krebs Figs 3 and 13). However, Krebs also teaches wherein the second counter-torque feature includes a protrusion (Krebs Fig 13, 82e) extending from the actuator (Krebs Fig 5, actuator member 112) and disposed within a slit (Krebs 74) defined by the stem component.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson as modified by Krebs to incorporate wherein the second counter-torque feature includes a protrusion extending from the trailing end of the stem component, as taught and suggested by Krebs in order to allow the stem component to be adjusted by a gripper, creating an area for grasping (Krebs [0041] and [0140]).
Regarding claim 34, Nelson as modified by Krebs discloses the invention substantially as claimed and as discussed above with respect to claim 31, and additionally teaches wherein the second counter-torque feature includes a recess (Krebs Fig 3, 106/102) defined by the trailing end of the stem component (Krebs Fig 3), the recess sized and configured to receive a projection that extends from a surface of another component of the prosthesis (Krebs [0041]).
Regarding claim 35, Nelson as modified by Krebs discloses the invention substantially as claimed and as discussed above with respect to claim 31, and additionally teaches wherein the second counter-torque feature includes a flat formed at the trailing end of the stem component (Krebs Fig 3, 106) the flat configured to be engaged by a complementary surface of another component of the prosthesis (Krebs [0041]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Myers et al. US 20080255560 A1 discloses a fracture stabilization system.
Tontz et al. US 20130090655 A1 discloses a device for establishing supportive forces in the bony structure of a skeleton.
Hustedt et al discloses US 20180078293 A1 an implant and method for long bone fixation.
Reed et al. US 20110301653 A1 discloses a bone implant with expansion portion.
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 Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.F./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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