Detailed Action
This office action is for US application number 18/527,644 evaluates the claims as filed on October 28, 2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 28, 2025 has been entered.
Response to Arguments
Applicant's arguments filed October 28, 2025 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Sweeney, Tyber, Grant, and Morris teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
Applicant’s arguments with respect to the combination of Tyber and Morris have been considered but are moot because the arguments do not apply to the current rejection.
Claim Objections
Claim(s) 11 is/are objected to because of the following informalities:
Claim 11 line 2 should read “to the outer shaft portion .
Appropriate correction is required.
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(s) 1-4, 6, 8-13, and 15-18 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “the head portion having a distal end portion with a geometry keyed to the proximal region of the cannulation of the outer shaft portion” in lines 5-6 and the scope of “keyed” as the ordinary meaning of the term does not appear to be applicable in this context and there does not appear to be an alternate definition in the specification. Paragraph 26 does provide that because 300 is keyed to the geometry of 210, 310 includes a matched cross-sectional profile to accommodate 210. Examiner is interpreting this as referring to, and suggests amending as, “the head portion having a distal end portion with a geometry matched to the proximal region of the cannulation of the outer shaft portion”.
Claim(s) 9 is/are unclear with regards to “one of the head portion and the second head portion including a threaded external surface” in lines 2-3 and where such a threaded external surface is disclosed that is in addition to the claimed head portion “threaded external surface” as claim 1 lines 8-9 . Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 10 is/are unclear with regards to “the head portion having a distal end portion with a geometry keyed to the proximal region of the cannulation of the outer shaft portion” in lines 5-6 and the scope of “keyed” as the ordinary meaning of the term does not appear to be applicable in this context and there does not appear to be an alternate definition in the specification. Paragraph 26 does provide that because 300 is keyed to the geometry of 210, 310 includes a matched cross-sectional profile to accommodate 210. Examiner is interpreting this as referring to, and suggests amending as, “the head portion having a distal end portion with a geometry matched to the proximal region of the cannulation of the outer shaft portion”.
Claim(s) 2-4, 6, 8, 11-13, and 15-18 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6, 13, 17, 18, 10, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sweeney et al. (US 2006/0264954, hereinafter “Sweeney”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 1, Sweeney discloses an orthopedic compression device (800, Figs. 8-13D, abstract, ¶s 38 and 62, where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120 and ¶62 discloses that 800 includes similar components to 100 except as noted for 110) comprising: an outer shaft portion (120, Figs. 8, 9, and 12A-13D, ¶38; where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120) having a threaded outer distal end (170, Fig. 1, ¶37) and having an inner cannulation (180, Figs. 5B, 9, and 12B, ¶37) extending from an opening (Fig. 12B) in a proximal end (Fig. 12B) towards an inner distal end (lower end as shown in Fig. 12A, Fig. 12A), the inner cannulation having a proximal region (185, Figs. 10C and 12B, ¶38, where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120 and ¶62 discloses that 800 includes similar components to 100 except as noted for 110); a head portion (110, Figs. 8-10C and 13A-13D, ¶38 where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120 and ¶62 discloses that 800 includes similar components to 100 except as noted for 110), the head portion having a distal end portion (150, Figs. 3B, 3C, and 12B, ¶s 36 and 38; where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120 and ¶62 discloses that 800 includes similar components to 100 except as noted for 110) with a geometry matched to the proximal region of the cannulation of the outer shaft portion (Figs. 9, 10C, and 12B, ¶38) capable of allowing rotation of the head portion to drive rotation of the outer shaft portion (¶s 38 and 41), the head portion including an inner channel (250, 185, 180, Figs. 9-10C, and 12B, ¶38), wherein the head portion includes a threaded external surface (810, Figs. 8-10B, and 13A-13D, ¶62); and an inner shaft portion (200), the inner shaft portion formed from a superelastic material (Fig. 11, ¶s 46-48) and having a stop (400) at a proximal end thereof (right end as shown in Fig. 11, Fig. 11), the stop engaging a stop surface (surface of “a feature” of ¶43, where ¶43 discloses that 400 interferes with “a feature” of 110; where “a feature” capable of interfering with 400 necessarily comprises at least a surface) formed within the head portion (¶43 discloses that 400 interferes with “a feature” of 110), the inner shaft portion extending through the inner channel and coupled to the outer shaft portion (coupled to 120 via 220, Fig. 9, ¶43, ¶43 discloses that 220 is fixedly retained in 120); wherein the inner shaft portion elongates and is placed into tension upon separation of the head portion and outer shaft portion (¶63) to thereby cause a compressive force between said head portion and said outer shaft portion upon said separation (¶63).
As to claim 2, Sweeney discloses that a proximal end of the head portion (left end as shown in Fig. 10B) includes a first driver interface (250, Fig. 10B, ¶41) capable of receiving a corresponding first driver (“driver” of ¶41, ¶41) used to rotate said head portion and to cause driven rotation of the outer shaft portion (¶s 38 and 41).
As to claim 3, Sweeney discloses that the first driver interface comprises a star driver slot (Fig. 10B, ¶41).
As to claim 6, Sweeney discloses that threading on the threaded external surface of the head portion has a different thread pitch from a pitch of threading on the threaded outer distal end of the outer shaft portion (¶62).
As to claim 13, Sweeney discloses a method (Figs. 13A-13D, ¶63) comprising providing the orthopedic compression device of claim 1 (as detailed above), driving said threaded outer distal end of said outer shaft portion into bone across a bone interface (at 710, Figs. 13A-13D, ¶63) a sufficient distance to cause separation of said head portion and said outer shaft portion (Fig. 13C), whereby said inner shaft portion elongates and is placed under tension to cause a compressive force across said bone interface (¶63).
As to claim 17, Sweeney discloses that a proximal end of the head portion (left end as shown in Fig. 10B) includes a first driver interface (250, Fig. 10B, ¶41) capable of receiving a corresponding first driver (“driver” of ¶41, ¶41) used to rotate said head portion and to cause driven rotation of the outer shaft portion (¶s 38 and 41).
As to claim 18, Sweeney discloses that threading on the threaded external surface of the head portion has a different thread pitch from a pitch of threading on the threaded outer distal end of the outer shaft portion (¶62).
As to claim 10, Sweeney discloses a method (Figs. 8-13D, abstract, ¶s 38 and 62, where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120 and ¶62 discloses that 800 includes similar components to 100 except as noted for 110) capable of use for assembling an orthopedic compression device (800, abstract, Figs. 8-13D, abstract, ¶s 38 and 62, where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120 and ¶62 discloses that 800 includes similar components to 100 except as noted for 110), the method comprising: providing an outer shaft portion (120, Figs. 8, 9, and 12A-13D, ¶38; where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120) having a threaded outer distal end (170, Fig. 1, ¶37) and having an inner cannulation (180, Figs. 5B, 9, and 12B, ¶37) extending from an opening (Fig. 12B) in a proximal end (Fig. 12B) towards an inner distal end (lower end as shown in Fig. 12A, Fig. 12A), the inner cannulation having a proximal region (185, Figs. 10C and 12B, ¶38, where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120 and ¶62 discloses that 800 includes similar components to 100 except as noted for 110); a head portion (110, Figs. 8-10C and 13A-13D, ¶38 where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120 and ¶62 discloses that 800 includes similar components to 100 except as noted for 110), the head portion having a distal end portion (150, Figs. 3B, 3C, and 12B, ¶s 36 and 38; where ¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120 and ¶62 discloses that 800 includes similar components to 100 except as noted for 110) with a geometry matched to the proximal region of the cannulation of the outer shaft portion (Figs. 9, 10C, and 12B, ¶38) capable of allowing rotation of the head portion to drive rotation of the outer shaft portion (¶s 38 and 41), the head portion including a first driver interface (250, Fig. 10B, ¶41), an inner channel (250, 185, 180, Figs. 9-10C, and 12B, ¶38), an inner stop surface (surface of “a feature” of ¶43, where ¶43 discloses that 400 interferes with “a feature” of 110; where “a feature” capable of interfering with 400 necessarily comprises at least a surface), and a threaded external surface (810, Figs. 8-10B, and 13A-13D, ¶62); and an inner shaft portion (200), the inner shaft portion formed from a superelastic material (Fig. 11, ¶s 46-48) and having a stop (400) at a proximal end thereof (right end as shown in Fig. 11, Fig. 11); passing a distal end of the inner shaft portion (left end of 205 as shown in Fig. 11, 220, Fig. 11) through the inner channel of the head until the stop of the inner shaft portion engages said stop surface (Fig. 9, ¶43); introducing the distal end of the inner shaft portion into the inner cannulation of the outer shaft portion through said opening in said proximal end (Fig. 9, ¶43); and coupling the inner shaft portion to the outer shaft portion (¶43), the distal end portion of the head portion at least partially disposed within the proximal region of the inner cannulation of the outer shaft portion (¶38 discloses that 150 may be formed on 110 with corresponding orifice 185 formed in 120).
As to claim 16, Sweeney discloses that threading on the threaded external surface of the head portion has a different thread pitch from a pitch of threading on the threaded outer distal end of the outer shaft portion (¶62).
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 of this title, 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.
Claim(s) 4, 11, 12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Tyber et al. (US 2010/0076498, hereinafter “Tyber”).
As to claim 4, Sweeney discloses the invention of claim 1 wherein the inner shaft portion is coupled to the outer shaft portion (coupled to 120 via 220, Fig. 9, ¶43, ¶43 discloses that 220 is fixedly retained in 120); where any retention means for fixedly coupling the inner shaft portion to the head portion and the outer shaft portion may be used (¶43).
Sweeney is silent to the inner shaft portion includes a thread disposed on a distal end thereof, the thread engaging a thread on the inner distal end of the outer shaft portion to cause coupling of the inner shaft portion and the outer shaft portion.
Tyber teaches a similar orthopedic compression device (100, Figs. 1-8 and 14, abstract, ¶35) comprising: an outer shaft portion (120, Figs. 1, 2, 4, and 6a-6c) having a threaded outer distal end (414 with threads 416, Fig. 4, ¶36) and having an inner cannulation (402, 418, 420, Fig. 4, ¶36) extending from an opening (of 402, Fig. 4, ¶36) in a proximal end (406) towards an inner distal end (408), the inner cannulation having a proximal region (402, Fig. 4, ¶36); a head portion (110, Figs. 1, 2, 3, and 6a-6c), the head portion having a distal end portion (320, 322) with a geometry (hex, Fig. 3, ¶35) matched to the proximal region of the cannulation of the outer shaft portion (¶s 35 and 36) capable of allowing rotation of the head portion to drive rotation of the outer shaft portion (¶35), the head portion including an inner channel (302, 318. 324, Fig. 3, ¶35), wherein the head portion includes an external surface (Figs. 1, 6a-6c, and 8); and an inner shaft portion (230, Figs. 2, 5, and 14), the inner shaft portion formed from a superelastic material (¶s 38, 44, and 55) and having a stop (lower surface of 504 as shown in Fig. 2 and 5, ¶38 discloses 504 abutting 315 when 230 is slidably coupled within 302, 318, and 324 of 110) at a proximal end (504) thereof (Fig. 5), the stop engaging a stop surface (315, Fig. 3, ¶38) formed within the head portion (Fig. 3), the inner shaft portion extending through the inner channel and coupled to the outer shaft portion (via engagement of 518 and 418, Figs. 4 and 5, ¶s 35 and 38); wherein the inner shaft portion elongates and is placed into tension upon separation of the head portion and outer shaft portion (Fig. 6C, ¶44) to thereby cause a compressive force between said head portion and said outer shaft portion upon said separation (710, Fig. 7, ¶s 44 and 45); wherein the inner shaft portion includes a thread (518) disposed on a distal end thereof (Figs. 2 and 5, ¶s 36 and 38), the thread engaging a thread (“threads” of aperture 418 of ¶36, Fig. 4, ¶36) on the inner distal end of the outer shaft portion (Fig. 4, ¶36) to cause coupling of the inner shaft portion and the outer shaft portion (¶36); the inner shaft portion including a second driver interface (Fig. 5) disposed at the proximal end of the inner shaft portion (Fig. 5), the inner shaft portion capable of rotating (to engage threads of 418 and 518, ¶s 36, 38, and 39)
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/specify that the any retention means for fixedly coupling the inner shaft portion to the outer shaft portion as disclosed by Sweeney comprise a thread on the inner shaft portion, corresponding thread within the outer shaft portion, and a second driver interface disposed at the proximal end of the inner shaft portion as taught by Tyber in order to threadedly/mechanically couple the inner shaft portion to the outer shaft portion (Tyber ¶36), i.e. predictably retain the inner shaft portion within the outer shaft portion (Sweeney ¶43) using a known connection mechanism (Tyber Figs. 2 and 4).
As to claims 11 and 12, Sweeney discloses the invention of claim 10 as well as coupling the inner shaft portion to the outer shaft portion (coupled to 120 via 220, Fig. 9, ¶43, ¶43 discloses that 220 is fixedly retained in 120); where any retention means for fixedly coupling the inner shaft portion to the head portion and the outer shaft portion may be used (¶43). As to claim 12, Sweeney discloses that the first driver interface comprises a star driver slot (Fig. 10B, ¶41).
Sweeney is silent to engaging a driver with a second driver interface disposed at the proximal end of the inner shaft portion and rotating the driver. As to claim 12, Sweeney is silent to the second driver interface comprises a Phillips driver slot.
Tyber teaches a similar method (Figs. 1-7, ¶39) capable of use for assembling a similar orthopedic compression device (Figs. 1-7, abstract, ¶s 35 and 39), the method comprising: providing an outer shaft portion (120, Figs. 1, 2, 4, and 6a-6c) having a threaded outer distal end (414 with threads 416, Fig. 4, ¶36) and having an inner cannulation (402, 418, 420, Fig. 4, ¶36) extending from an opening (of 402, Fig. 4, ¶36) in a proximal end (406) towards an inner distal end (408), the inner cannulation having a proximal region (402, Fig. 4, ¶36); a head portion (110, Figs. 1, 2, 3, and 6a-6c), the head portion having a distal end portion (320, 322) with a geometry (hex, Fig. 3, ¶35) matched to the proximal region of the cannulation of the outer shaft portion (¶s 35 and 36) capable of allowing rotation of the head portion to drive rotation of the outer shaft portion (¶35), the head portion including a first driver interface (302), an inner channel (302, 318. 324, Fig. 3, ¶35), an inner stop surface (portion of 315 with label of “315” in Fig. 3, Fig. 3, ¶38; where ¶38 discloses that 504 abuts this portion of 315 when 110 and 230 are slidably coupled), and an external surface (Figs. 1, 6a-6c, and 8); and an inner shaft portion (230, Figs. 2, 5, and 14), the inner shaft portion formed from a superelastic material (¶s 38, 44, and 55) and having a stop (lower surface of 504 as shown in Fig. 2 and 5, ¶38 discloses 504 abutting 315 when 230 is slidably coupled within 302, 318, and 324 of 110) at a proximal end (504) thereof (Fig. 5), passing a distal end of the inner shaft portion (Figs. 2 and 5, ¶s 36 and 38) through the inner channel of the head until the stop of the inner shaft portion engages said stop surface (¶s 38 and 39); introducing the distal end of the inner shaft portion into the inner cannulation of the outer shaft portion through said opening in said proximal end (Figs. 2, 4, and 5, ¶s 36 and 39); and coupling the inner shaft portion to the outer shaft portion (via threads of 418 and 518, ¶s 36, 38, and 39), the distal end portion of the head portion at least partially disposed within the proximal region of the inner cannulation of the outer shaft portion (Fig. 1, ¶39); wherein coupling the inner shaft portion to the outer shaft portion includes a second driver interface (Fig. 5) disposed at the proximal end of the inner shaft portion (Fig. 5) and rotating the inner shaft portion (to engage threads of 418 and 518, ¶s 36, 38, and 39).
Sweeney further teaches that rotating components to engage threaded portions comprises engaging a driver (“driver” of ¶41, ¶41) with a driver interface (Fig. 10B) disposed at the proximal end of the device (Fig. 9). As to claim 12, Sweeney further teaches that the second driver interface comprises a star driver slot (Fig. 10B), a Phillips driver slot (¶41), an Allen head configuration (¶41) or the like (¶41).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/specify that the any retention means for fixedly coupling the inner shaft portion to the outer shaft portion and the method as disclosed by Sweeney comprise a thread on the inner shaft portion, corresponding thread within the outer shaft portion, and a second driver interface disposed at the proximal end of the inner shaft portion and the method comprises rotating the inner shaft portion as taught by Tyber in order to threadedly/mechanically couple the inner shaft portion to the outer shaft portion (Tyber ¶36), i.e. predictably retain the inner shaft portion within the outer shaft portion (Sweeney ¶43) using a known connection mechanism (Tyber Figs. 2 and 4). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method as disclosed by the combination of Sweeney and Tyber by providing and engaging a driver and rotating the driver as taught by Sweeney in order to rotate the shaft portion (to engage threads of Tyber 418 and 518, Tyber ¶s 36, 38, and 39) using known driving tools to mate with known driver interfaces (Sweeney ¶41).
As to claim 15, Sweeney discloses the invention of claim 10 as well as coupling the inner shaft portion to the outer shaft portion (coupled to 120 via 220, Fig. 9, ¶43, ¶43 discloses that 220 is fixedly retained in 120); where any retention means for fixedly coupling the inner shaft portion to the head portion and the outer shaft portion may be used (¶43).
Sweeney is silent to the inner shaft portion includes a thread disposed on a distal end thereof, the thread engaging with a thread on the inner distal end of the outer shaft portion.
Tyber teaches a similar method (Figs. 1-7, ¶39) capable of use for assembling a similar orthopedic compression device (Figs. 1-7, abstract, ¶s 35 and 39), the method comprising: providing an outer shaft portion (120, Figs. 1, 2, 4, and 6a-6c) having a threaded outer distal end (414 with threads 416, Fig. 4, ¶36) and having an inner cannulation (402, 418, 420, Fig. 4, ¶36) extending from an opening (of 402, Fig. 4, ¶36) in a proximal end (406) towards an inner distal end (408), the inner cannulation having a proximal region (402, Fig. 4, ¶36); a head portion (110, Figs. 1, 2, 3, and 6a-6c), the head portion having a distal end portion (320, 322) with a geometry (hex, Fig. 3, ¶35) matched to the proximal region of the cannulation of the outer shaft portion (¶s 35 and 36) capable of allowing rotation of the head portion to drive rotation of the outer shaft portion (¶35), the head portion including a first driver interface (302), an inner channel (302, 318. 324, Fig. 3, ¶35), an inner stop surface (portion of 315 with label of “315” in Fig. 3, Fig. 3, ¶38; where ¶38 discloses that 504 abuts this portion of 315 when 110 and 230 are slidably coupled), and an external surface (Figs. 1, 6a-6c, and 8); and an inner shaft portion (230, Figs. 2, 5, and 14), the inner shaft portion formed from a superelastic material (¶s 38, 44, and 55) and having a stop (lower surface of 504 as shown in Fig. 2 and 5, ¶38 discloses 504 abutting 315 when 230 is slidably coupled within 302, 318, and 324 of 110) at a proximal end (504) thereof (Fig. 5), passing a distal end of the inner shaft portion (Figs. 2 and 5, ¶s 36 and 38) through the inner channel of the head until the stop of the inner shaft portion engages said stop surface (¶s 38 and 39); introducing the distal end of the inner shaft portion into the inner cannulation of the outer shaft portion through said opening in said proximal end (Figs. 2, 4, and 5, ¶s 36 and 39); and coupling the inner shaft portion to the outer shaft portion (via threads of 418 and 518, ¶s 36, 38, and 39), the distal end portion of the head portion at least partially disposed within the proximal region of the inner cannulation of the outer shaft portion (Fig. 1, ¶39); the inner shaft portion includes a thread (518) disposed on a distal end thereof (Figs. 2 and 5, ¶s 36 and 38), the thread engaging a thread (“threads” of aperture 418 of ¶36, Fig. 4, ¶36) on the inner distal end of the outer shaft portion (Fig. 4, ¶36) to cause coupling of the inner shaft portion and the outer shaft portion (¶36); wherein coupling the inner shaft portion to the outer shaft portion includes a second driver interface (Fig. 5) disposed at the proximal end of the inner shaft portion (Fig. 5) and rotating the inner shaft portion (to engage threads of 418 and 518, ¶s 36, 38, and 39).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/specify that the any retention means for fixedly coupling the inner shaft portion to the outer shaft portion and the method as disclosed by Sweeney comprise a thread on the inner shaft portion, corresponding thread within the outer shaft portion, and a second driver interface disposed at the proximal end of the inner shaft portion and the method comprises rotating the inner shaft portion as taught by Tyber in order to threadedly/mechanically couple the inner shaft portion to the outer shaft portion (Tyber ¶36), i.e. predictably retain the inner shaft portion within the outer shaft portion (Sweeney ¶43) using a known connection mechanism (Tyber Figs. 2 and 4).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Grant et al. (US 2009/0264885, hereinafter “Grant”).
As to claim 8, Sweeney discloses the invention of claim 2 as well as a medical procedure kit (¶41) comprising the orthopedic compression device of claim 2 (as detailed above) and a first driver (“driver” of ¶41, ¶41), the first driver corresponding to said first driver interface (¶41).
Sweeney is silent to the kit being within a container.
Grant teaches a similar medical procedure kit (100 and “container” of ¶41, ¶41) comprising, within a container (¶41), the orthopedic compression device of (100) comprising: a shaft portion (104, 106) having a threaded outer distal end (142, Figs. 1-3 and 5, ¶39) and having an inner cannulation (146, Fig. 5) extending from an opening in a proximal end towards an inner distal end (Fig. 5), the inner cannulation having a proximal region (Fig. 5); a head portion (102), the head portion having a distal end portion with a geometry (134) matched to the proximal region of the shaft portion (¶45).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the kit as disclosed by the combination of Sweeney by providing the kit packaged in a container as taught by Grant in order to provide a sterile assembly (Grant ¶41).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Grant and Morris et al. (US 2010/0036440, hereinafter “Morris”).
As to claim 9, Sweeney discloses the invention of claim 2 as well as a medical procedure kit (¶41) comprising the orthopedic compression device of claim 2 (as detailed above) and a first driver (“driver” of ¶41, ¶41), wherein an alternate compression device (Figs. 1-7D) disclose discloses a second head portion (110, 130, Figs. 1-3C and 7A-7D, ¶62), the head portion of claim 1 including a threaded external surface (as defined above in reference to claim 1) and the second head portion including an unthreaded bone-engaging external surface (Figs. 1-3C and 7A-7D).
Sweeney is silent to the kit being within a container and the kit containing both the head portion and the second head portion.
Grant teaches a similar medical procedure kit (100 and “container” of ¶41, ¶41) comprising, within a container (¶41), the orthopedic compression device of (100) comprising: a shaft portion (104, 106) having a threaded outer distal end (142, Figs. 1-3 and 5, ¶39) and having an inner cannulation (146, Fig. 5) extending from an opening in a proximal end towards an inner distal end (Fig. 5), the inner cannulation having a proximal region (Fig. 5); a head portion (102), the head portion having a distal end portion with a geometry (134) matched to the proximal region of the shaft portion (¶45).
Morris teaches a similar orthopedic compression device kit (Figs. 1-7) comprising: an outer shaft portion (20, Figs. 1-3) having a threaded outer distal end (24, Fig. 1, ¶37) and having an inner cannulation (34, 33, Fig. 1) extending from an opening (33) in a proximal end (28) towards an inner distal end (Fig. 1), the inner cannulation having a proximal region (Fig. 1); a head portion (22), the head portion having a distal end portion (39) with a geometry matched to the proximal region of the cannulation of the outer shaft portion (Fig. 3, ¶48), the head portion including an inner channel (Fig. 1); and a second head portion (Fig. 7, ¶53); and a second head portion (22, Fig. 7), the second head portion including a threaded external surface (35, Figs. 1-3 and 7, ¶40) of varying pitch (¶53).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the kit as disclosed by the combination of Sweeney by providing the kit packaged in a container as taught by Grant in order to provide a sterile assembly (Grant ¶41). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the kit as disclosed by the combination of Sweeney to include differently configured shaft and head portions as taught by Morris in order to provide a customized 2-piece bone screw apparatus (Morris ¶53) to provide flexibility in enabling a surgeon to select a shaft of desired length and head portion of desired length as well as to also vary in the pitch and length of the external threaded portion (Morris ¶53).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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/AMY R SIPP/Primary Examiner, Art Unit 3775