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 .
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 7 & 20 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 7 at Lines 2-4 recites “such that cutting through the first and second end plate slits defines a thickness dimension of an allograft, cutting through a side plate slit of the side plate defines a height dimension of the allograft, and cutting along the outer side surface at least partially defines a width dimension of the allograft.” which renders the claim indefinite as it is unclear if the allograft is being positively recited or functionally recited since the limitations are reciting active steps relating to sizing the allograft in a device claim. For purposes of examination, the claim is being interpreted as “wherein the second guide surface is a portion of an outer side surface of the side plate, such that [[cutting through]] the first and second end plate slits are configured to accept a cutting tool for cutting an allograft and defining [[defines]] a thickness dimension of [[an]] the allograft, [[cutting through]] a side plate slit of the side plate is configured to accept the cutting tool for cutting the allograft and defining [[defines]] a height dimension of the allograft, and [[cutting along]] the outer side surface is configured to accept the cutting tool for cutting the allograft and at least partially defining [[defines]] a width dimension of the allograft.” Appropriate correction is required.
Claim 20 at Line 7 recites the limitation “configured to clamp the donor bone”, and Line 8 recites the limitation “a guide configured for attachment to a donor bone while the donor bone is held fixed” which renders the claim indefinite as: 1) it is unclear if “the donor bone” of Line 7 is the same as the “donor bone material” recited in Line 1 of the preamble, the donor bone material of the preamble, or another donor bone/something else, and 2) it is unclear if the recited “a donor bone” of Line 8 is the same as the donor bone previously recited in Line 7, or an additional donor bone, or the donor bone material of the preamble. For purposes of examination, each instance of “donor bone” after the preamble is being interpreted as “the donor bone material”. Appropriate correction is required.
Claim 20 at Lines 14-17 recites “wherein when the first and second gripping surfaces hold the donor bone fixed relative to the frame and the guide is fixed relative to the donor bone, a portion of the donor bone separates an entirety of the frame from an entirety of the guide, and the donor bone remains stable while cuts are made along the first guide surface and the second guide surface.” which renders the claim indefinite as 1) it is unclear if the donor bone is being positively recited or functionally recited since the limitations are reciting active steps relating to the donor bone being held and fixed by the frame and guide in a device claim, and 2) it is unclear how a portion of the donor bone can separate an entirety of the frame from an entirety of the guide. For purposes of examination, Lines 14-17 are being interpreted as “wherein the first and second gripping surfaces are configured to hold the donor bone material in a fixed position relative to the frame and the guide is configured to be fixed relative to the donor bone material such that an entirety of the frame is spaced from an entirety of the guide by a portion of the donor bone material, and wherein the donor bone material is configured to remain stable while cuts are made along the first guide surface and the second guide surface.” Appropriate correction is required.
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) 1, 4-7 & 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lionberger et al. (US PG Pub No. 2004/0260301).
Regarding Claim 1, Lionberger et al. discloses a guide (10, Figs. 1-11, Paragraphs [0023-0037]) comprising: an end plate (upper horizontal/anterior block portion 11, Figs. 1 & 4, Paragraph [0023]) having an outer surface (exterior surface of 11, Figs. 3-4) and a bone-facing surface (interior/bone adjacent surface of 11, Figs. 3-4) opposite the outer surface, the end plate including a first guide surface (opening in 11 defining slot 20, Figs. 1 & 5); and a side plate (lower vertical/distal block portion 12, Figs. 1-2 & 4, Paragraph [0023]) extending at an angle from the end plate (Fig. 1), the side plate including a second guide surface (opening in 12 defining left slot 23, Figs. 1-2 & 5).
Regarding Claim 4, Lionberger et al. discloses wherein the end plate and the side plate are formed together monolithically (Figs. 1 & 5).
Regarding Claim 5, Lionberger et al. discloses wherein the first guide surface defines part of a first end plate slit (slot 20, Fig. 5) passing through the outer and bone-facing surfaces of the end plate (Paragraphs [0024-0025]).
Regarding Claim 6, Lionberger et al. discloses a second end plate slit (slot 21, Figs. 1 & 5) spaced apart from the first end plate slit, the second end plate slit passing through the outer and bone-facing surfaces of the end plate (Paragraphs [0024-0026]) and defining a cutting plane at an angle relative to a cutting plane of the first end plate slit (Fig. 5).
Regarding Claim 7 as best understood, Lionberger et al. discloses wherein the second guide surface is a portion of an outer side surface of the side plate (left lateral side surface 13, Figs. 1-2 & 5), such that the first and second end plate slits (20 & 21) are capable of accepting a cutting tool (surgical saw, Paragraph [0024]) for cutting an allograft and defining a thickness dimension of the allograft, a side plate slit of the side plate (horizontal slot 22 in 12, Figs. 1-2 & 5) is capable of accepting the cutting tool for cutting the allograft and defining a height dimension of the allograft, and the outer side surface (left lateral side surface 13) is capable of accepting the cutting tool for cutting the allograft and at least partially defining a width dimension of the allograft (With respect to the functional language above, the slots and exterior surfaces of the guide 10 are fully capable of accepting and guiding the surgical saw to cut a height, width, and thickness of an allograft as recited.).
Regarding Claim 11, Lionberger et al. discloses wherein the side plate includes opposing outer side surfaces (left lateral side surface 13 and right lateral side surface 14, Fig. 2) extending from the end plate to a free end of the side plate (lower-most horizontal end surface of 12, Fig. 2), and the second guide surface defines part of a side plate slit (left slot 23, Figs. 1-2 & 5) in between the opposing outer side surfaces.
Regarding Claim 12, Lionberger et al. discloses wherein the second guide surface is an outer side surface of the side plate (left lateral side surface 13, Figs. 1-2).
Regarding Claim 13, Lionberger et al. discloses wherein the side plate is a first side plate and the guide further comprises a second side plate (angled central plate portion extending between 11 & 12, Fig. 1) extending from the end plate and from the first side plate (Figs. 3-5), the second side plate being oriented at an angle relative to the end plate and the first side plate (Fig. 4).
Regarding Claim 14, Lionberger et al. discloses wherein the end plate and the side plate are capable of being attached directly to a donor bone (via stabilizing pins 40 through fixation lugs 30 in 11 and fixation lugs 31 in 12, Figs. 1-3, Paragraph [0030]).
Regarding Claim 15, Lionberger et al. discloses wherein the guide defines openings (apertures 32 in fixation lugs 30 in 11 and apertures 32 in fixation lugs 31 in 12) each configured to receive a pin (stabilizing pins 40, Figs. 1-3) to fix the guide to a donor bone (Paragraph [0030]).
Claim(s) 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abdelgany et al. (US PG Pub No. 2002/0082604).
Regarding Claim 16, Abdelgany et al. discloses a method of retrieving an allograft for implantation in a patient (Paragraph [0041-0044]) comprising: securing a cutting guide (guide 10, Figs. 1-4) to a donor bone (donor tibia 18, Fig. 1, Paragraph [0041]) such that an end plate (22, Fig. 1) of the cutting guide faces an end surface of the donor bone (See examiner annotated Fig. 2 below) and a side plate (24, Fig. 1) of the cutting guide that extends from the end plate (via 12, Paragraphs [0031-0032]) faces a side surface of the donor bone (Paragraph [0031]) (See examiner annotated Fig. 2 below); forming a first bone cut through the end surface of the donor bone (through cutting guide 14c, Figs. 2 & 7C, Paragraphs [0034-0035]) using a cutting tool (cutting device such as sagittal saw, Paragraph [0042]) positioned along a first guide surface (right-most vertical slot formed through 14c as seen in examiner annotated Fig. 7C below) of the end plate (Paragraph [0033]); forming a second bone cut through the side surface of the donor bone using the cutting tool positioned along a second guide surface of the side plate (top left-most angled slot formed through 14c as seen in examiner annotated Fig. 7C below) (Paragraph [0042]); and forming a third bone cut through the donor bone, the third bone cut being at an angle relative to each of the first and second bone cuts (Paragraph [0042]), wherein a portion of the donor bone defined by the first, second and third bone cuts encompasses a bone segment to be implanted into a joint of the patient (Figs. 5-6, “As one example, the resulting bone graft may appear as shown in FIG. 6, having a roughened surface 40. As mentioned above, the present invention provides the flexibility of providing a wide variety of bone graft shapes, including, but not limited to, grafts that are straight, wedge-shaped, and elliptically shaped.”, Paragraph [0044]).
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Regarding Claim 17, Abdelgany et al. discloses forming a fourth bone cut through the end surface of the donor bone using the cutting tool (Paragraph [0042]) positioned through a plate slit in the end plate (opening 20 formed through 22 where cutting guide 14c is inserted, Fig. 1, “One example of various ways in which the cutting guide 14 can be detachably mounted to the main body 12 is to provide a cutting guide-receiving structure 20 associated with the main body 12, as shown in FIGS. 1-3. For example, as shown in FIG. 1, the cutting guide-receiving structure 20 may be an opening or nesting structure and the cutting guide 14 may be in the form of an insert sized to fit within the opening or nesting structure.”, Paragraph [0034]) (See examiner annotated Fig. 7C above).
Regarding Claim 18, Abdelgany et al. discloses forming a fourth bone cut through the side surface of the donor bone using the cutting tool (Paragraph [0042]) positioned through a plate slit in the side plate (See examiner annotated Fig. 7C above) (opening 20 formed through 24 where cutting guide 14c is inserted, Fig. 1, “One example of various ways in which the cutting guide 14 can be detachably mounted to the main body 12 is to provide a cutting guide-receiving structure 20 associated with the main body 12, as shown in FIGS. 1-3. For example, as shown in FIG. 1, the cutting guide-receiving structure 20 may be an opening or nesting structure and the cutting guide 14 may be in the form of an insert sized to fit within the opening or nesting structure.”, Paragraph [0034]) (See examiner annotated Fig. 7C above).
Regarding Claim 19, Abdelgany et al. discloses wherein the first guide surface (right-most vertical slot formed through 14c) defines part of a plate slit in the end plate (when 14c is inserted into the opening 20 formed through 22, Figs. 1 & 7c) and forming the first bone cut includes using the cutting tool positioned through the plate slit (Paragraph [0042]).
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steiner et al. (US PG Pub No. 2008/0255623).
Regarding Claim 20 as best understood, Steiner et al. discloses a system (Figs. 1-10, Paragraphs [0042-0054]) for retrieving donor bone material (210, Fig. 3, Paragraph [0045]) for implantation in a patient, the system comprising: a frame (workstation 20, Fig. 1) comprising: a first member (jaw 40, Fig. 7) including a first gripping surface (cutout surface 46, Figs. 2 & 7, Paragraph [0046]); and a second member (moveable jaw 60, Fig. 7) movably coupled to the first member (Paragraphs [0048-0049]), the second member including a second gripping surface (cutout surface 74, Figs. 2 & 7, Paragraph [0049]), wherein the first member and the second member are configured to clamp the donor bone (Figs. 3-6), and a guide (cutting assembly 140, Figs. 7 & 10, Paragraphs [0051-0052]) configured for attachment (via 146, Fig. 7A) to a donor bone (210) while the donor bone is held fixed by the first and second gripping surfaces (Figs. 7-7A), the guide comprising: an end plate (130, Fig. 6, Paragraph [0051]) having an outer surface (uppermost circumferential surface/rim, Figs. 6-7) and a bone-facing surface opposite the outer surface (lowermost surface/rim, Figs. 6-7), the end plate including a first guide surface (cannulation formed centrally through 130, Figs. 6-8); and a side plate (120, Fig. 6, Paragraph [0051]) extending at an angle from the end plate (Fig. 7), the side plate including a second guide surface (cannulation formed centrally through 120, Fig. 6), wherein when the first and second gripping surfaces hold the donor bone fixed relative to the frame and the guide is fixed relative to the donor bone (via 146, Figs. 7-7A), a portion of the donor bone separates an entirety of the frame from an entirety of the guide (Figs. 7A-8, Paragraphs [0039 & 0053]), and the donor bone remains stable while cuts are made along the first guide surface and the second guide surface (Figs. 7-8, Paragraphs [0039 & 0053]).
wherein the first and second gripping surfaces are configured to hold the donor bone material in a fixed position relative to the frame (Figs. 3-4, 7-7A) and the guide is configured to be fixed relative to the donor bone material (Fig. 5) such that an entirety of the frame is spaced from an entirety of the guide by a portion of the donor bone material (Figs. 7-7A), and wherein the donor bone material is configured to remain stable while cuts are made along the first guide surface and the second guide surface.
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.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lionberger et al. (US PG Pub No. 2004/0260301) in view of Luckman (US Patent No. 4,926,847).
Regarding Claims 2-3, Lionberger et al. discloses the claimed invention as stated above in claim 1, and further discloses wherein the guide includes a protrusion (stabilizing peg) that is capable of being positioned within a first trough (notch) on an end surface of a donor bone (“For a posterior cruciate sacrificing surgical procedure utilizing a tibia stabilizing peg (not shown), wherein the peg penetrates the notch of the femur for stability, an additional recess or cavity may be required to be drilled, sawed, or milled into the distal femur to accommodate the stabilizing peg.”, Paragraph [0054]), and wherein the side plate includes a bone-facing surface (interior/bone adjacent surface of 12, Figs. 1 & 4).
Lionberger et al. does not disclose that the protrusion is a central protrusion on the bone-facing surface of the end plate, and wherein the side plate bone-facing surface has a side plate central protrusion thereon, the side plate central protrusion being aligned with and offset from opposing outer side surfaces of the side plate and being sized to be positionable within a second trough on a side surface of the donor bone when the end plate central protrusion of the end plate is positioned within the first trough on the end surface of the donor bone. Lionberger et al. does disclose various apertures (26, Fig. 2; and 32, Fig. 5) and lugs (30 & 31, Fig. 2) on both the end plate (11) and the side plate (12) for accepting stabilizing pins (41 & 40, Fig. 1) for aligning and securing the guide to the bone (Paragraph [0030]).
Luckman discloses a surgical cutting block (12, Figs. 1 & 5, Abstract) configured to be removably secured to a bone for making cuts to the bone (Col. 3, Line 32- Col. 6, Line 6), wherein the block comprises spikes (38 & 38) secured to a central portion of a body (31) of the block (Col. 4, Lines 17-34) and configured to be driven into the bone to help position the block in the proper position (Fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the bone-facing surface of the end plate of Lionberger et al. to add two spikes secured to the central portion thereof, and modify the side plate to replace the pin apertures therethrough with two spikes secured to the bone-facing surface thereof as taught by Luckman in order to provide the guide with a means for initially securing the end plate and side plate in a desired position on the bone prior to insertion of the stabilization pins and cutting the bone.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lionberger et al. (US PG Pub No. 2004/0260301) in view of Masini (WIPO Pub No. WO 97/16129).
Regarding Claims 8-9, Lionberger et al. discloses the claimed invention as stated above in claim 1, and further discloses wherein the side plate (12) includes opposing outer side surfaces (left and right lateral side surfaces 13 & 14) extending from the end plate to a free end of the side plate (lower-most horizontal end surface of 12, Fig. 2), and the second guide surface defines part of a first side plate slit (left slot 23, Figs. 1-2 & 5) in between the opposing outer side surfaces, and the side plate further comprising a second side plate slit (right slot 23, Figs. 1-2 & 5), and wherein the end plate defines an opening (aperture 32 through left fixation lug 30 in 11, Figs. 1 & 5) configured to receive a first bone anchor (stabilizing pin 40, Figs. 1-2) and the side plate defines an opening (each aperture 32 through left fixation lug 31 in 12, Figs. 1 & 5) configured to receive a second bone anchor (stabilizing pin 40, Figs. 1-2).
Lionberger et al. does not disclose that a cutting plane of the second side plate slit is orthogonal to a cutting plane of the first side plate slit. Lionberger et al. does disclose in Paragraph [0027] that “A pair of second slots 23 are positioned, in tandem, as shown in FIGS. 1-2, just below the first horizontal slot on this portion of the cutting block guide, each of the second slots 23 being angled relative to the plane of the distal cutting block portion 12. These slots are sufficiently angled to provide for a chamfered posterior cut 4 into the femur. A typical angle of inclination for the second slots 23 is about 45 degrees; however, those of ordinary skill in the art will readily recognize that the angle may be increased or decreased as desired by the manufacturer. “
Masini discloses a bone cutting guide configured to be placed on a bone to make cuts thereon (204, Fig. 2, Abstract), wherein the guide comprises a plurality of guide surfaces and cutting slots formed therethrough (Fig. 2), and wherein the guide comprises first and second side plate slots (left and right centrally located slots 206, Fig. 2) defined between opposing outer side surfaces (left and right exterior lateral surfaces) and each extending along both the exterior surface and the respective side surface, wherein each side plate slot comprises first and second cutting guide surfaces such that a cutting plane along the first and second cutting guide surfaces of each side plate slot are orthogonal to one another (Fig. 2) such that two different cuts can be made based on a patient’s particular need through each of the side plate slots.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each of the first and second side plate slits of Lionberger et al. to include first and second cutting guide surfaces orthogonal to one another as taught by Masini in order to allow the guide to be used to cut an additional chamfered cut through the left and right side plate slits if needed based on a patient’s particular needs or a surgeons preference.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lionberger et al. (US PG Pub No. 2004/0260301) in view of Bonutti (US PG Pub No. 2003/0028196).
Regarding Claim 10, Lionberger et al. discloses the claimed invention as stated above in Claim 1, except wherein the first guide surface is an outer side surface of the end plate. The opening in 11 defining slot 20 extends between the left and right side lateral surfaces 13 & 14 but not entirely therebetween as seen in Figs. 1 & 5.
Bonutti discloses various embodiments of cutting guides configured to be placed on a bone to make cuts thereon, wherein one particular cutting guide (500, Fig. 38) comprises a guide surface defining a horizontal cutting slot (540) which extends between an exterior surface and an interior bone-facing surface of the guide and between left and right side lateral surfaces of the guide such that the slot continues along the right outer side surface of the guide and defining an open ended slot (Paragraph [0342]). Bonutti teaches that “The open end 542 of the slot 540 facilitates movement of the saw blade 170 along the slot and angling of the saw blade relative to the slot to maximize the extent of the initial portion of the tibial cut. Thus, the extent of the tibial cut formed during movement of the saw blade along the guide surface 530 on the tibial resection guide 500 is maximized by forming the slot 540 with the open end 542 so that the saw blade can be angled at the open end 542 of the slot.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the first guide surface defining the slot 20 in the endplate of Lionberger et al. to extend through the right outer side surface of the endplate such that the slot is open ended as taught by Bonutti in order to allow a cutting tool to be angled as needed at the open end of the slot based on the desired cuts needed on the bone.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775