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 Objections
Claim 4 is objected to because of the following informalities: In Line 2, the word “received” should be replaced with the word --receive--. Appropriate correction is required.
Claim 5 is objected to because of the following informalities:
In Line 3, the word “a” at the end of the line should be replaced with the word --the--.
In Line 4, the word “or” should be replaced with the word --of--.
Appropriate correction is required.
Claim 10 is objected to because of the following informalities and should be amended as follows: “10. The olecranon plate of claim 9, wherein one of the [[wasted]] waisted edge scallops of the first sidewall defines a first indentation and one of the waisted edge scallops of the second sidewall defines a second indentation, and the first indentation and the second indentation are aligned with a k-wire hole.” Appropriate correction is required.
Claim 14 is objected to because of the following informalities: In Line 2, the word “received” should be replaced with the word --receive--. Appropriate correction is required.
Claim 15 is objected to because of the following informalities:
In Line 4, the word “a” should be replaced with the word --the--.
In Line 5, the word “or” should be replaced with the word --of--.
Appropriate correction is required.
Claim 19 is objected to because of the following informalities: In Line 1, the claim number “1” should be replaced with the claim number --11-- since the preamble is reciting the system. Appropriate correction is required.
Claim 20 is objected to because of the following informalities and should be amended as follows: “20. The system of claim 19, wherein one of the waisted edge scallops of the first sidewall defines a first indentation and one of the waisted edge scallops of the second sidewall defines a second indentation, and the first indentation and the second indentation are aligned with a k-wire hole.” 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.
Claims 8 & 18 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.
Claims 8 & 18 recite the limitation “the shaft” and “the proximal end of the head portion” at Line 2. There is insufficient antecedent basis for these limitations in the claim. For purposes of examination, the limitations are being interpreted as “the shaft portion” and “a proximal end of the head portion”. 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) 1-7, 9, 11-17, & 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Driscoll et al. (US PG Pub No. 2004/0116930).
Regarding Claim 1, O’Driscoll et al. discloses a bone plate (120/120R, Figs. 4-9, Paragraphs [0096-0104]) comprising: a curved head portion (distal portion 130, Figs. 4 & 9) capable of conforming (via bone-facing surface 124, Figs. 5 & 8) to an olecranon (Paragraph [0103]); a shaft portion (proximal portion 128, Figs. 4 & 9) extending from the curved head portion and capable of extending towards a distal end of an ulna (the distal portion 130 is fully and structurally capable of conforming to an olecranon and the proximal portion 128 is fully and structurally capable of extending towards a distal ulna when the plate 120/120R is placed on a patient’s ulna/elbow as recited in the functional language above); an upper surface (122, Figs. 5, 7 & 9) comprising the curved head portion and the shaft portion; a lower surface (124, Figs. 5 & 8) comprising the curved head portion and the shaft portion and capable of contacting the ulna (Paragraph [0103]); a first sidewall (right side wall 126, Figs. 7-8) extending between the upper surface and the lower surface along a first side (right side of 120/120R when viewing Fig. 7 which is the upper side wall 126 when viewing Figs. 4 & 9) of the plate; and a second sidewall (left side wall 126, Figs. 7-8) extending between the upper surface and the lower surface along a second side (left side of 120/120R when viewing Fig. 7 which is the lower side wall 126 when viewing Figs. 4 & 9) of the plate, wherein the shaft portion is curved with a left-handed (120, Paragraphs [0095, 0104]) or a right-handed curvature (120R, Paragraphs [0095, 0104]) and configured for a left ulna or a right ulna, respectfully (“Plate 120R is configured for fixing bone discontinuities in the distal-lateral right humerus of a body. Thus plate 120R arcs to the left, rather than the right as described above for plate 120. Plates 120 and 120R, and all other left- and right-handed plates described herein, may be related to each other by substantial or complete mirror-image symmetry.”).
Regarding Claim 2, O’Driscoll et al. discloses wherein the plate is left-handed (120, Fig. 4, Paragraph [0104]) and the first sidewall of the shaft portion (right side of 120 when viewing Fig. 7 which is the upper side wall 126 when viewing Fig. 4) is convex (Fig. 4) and the second sidewall of the shaft portion (left side of 120 when viewing Fig. 7 which is the lower side wall 126 when viewing Fig. 4) is concave (Fig. 4).
Regarding Claim 3, O’Driscoll et al. discloses wherein the plate is right-handed (120R, Fig. 9, Paragraph [0104]) and the first sidewall of the shaft portion (right side of 120R when viewing Fig. 7 which is the upper side wall when viewing Fig. 9) is concave (Fig. 9) and the second sidewall of the shaft portion (right side of 120R when viewing Fig. 7 which is the lower side wall when viewing Fig. 9) is convex (Fig. 9).
Regarding Claim 4, O’Driscoll et al. discloses a first opening in the head portion (right most round opening 134 when viewing Figs. 4 & 9) configured to receive a first fastener (fastener/bone screw, Paragraphs [0078-0082, 0096, 0101-102]), wherein the first opening is capable of receiving the first fastener such that the first fastener extends toward a distal end of the ulna (“the openings may include tapered counterbores that bias a fastener toward (or away from) a bone discontinuity, for example, to provide compression.”, Paragraph [0079]).
Regarding Claim 5, O’Driscoll et al. discloses a plurality of second openings (left two round openings 134 when viewing Figs. 4 & 9) positioned distally of the first opening (distal end is at 142, proximal end is at 144, Fig. 4), wherein each second opening of the plurality of second openings is configured to receive a second fastener (fastener/bone screw, Paragraphs [0078-0082, 0096, 0101-102]), wherein each second opening is capable of receiving a second fastener such that each second fastener extends towards one or a coronoid process of the ulna or an anterior cortex of the ulna (“the openings may include tapered counterbores that bias a fastener toward (or away from) a bone discontinuity, for example, to provide compression.”, Paragraph [0079]).
Regarding Claim 6, O’Driscoll et al. discloses a third opening (right most opening 132, Fig. 4) positioned distally of the plurality of second openings (distal end is at 142, proximal end is at 144, Fig. 4), wherein the third opening is configured to receive a third fastener (fastener/bone screw, Paragraphs [0078-0082, 0096, 0101-102]), wherein the third opening is capable of receiving the third fastener such that the third fastener extends towards an olecranon process of the ulna (“the openings may include tapered counterbores that bias a fastener toward (or away from) a bone discontinuity, for example, to provide compression.”, Paragraph [0079]).
Regarding Claim 7, O’Driscoll et al. discloses a two-axis positioning slot (elongate opening 166, Figs. 4 & 9. 166 comprises a longitudinal axis in the length direction and a transverse axis extending in the width direction) positioned on the shaft portion configured to receive a positioning fastener (Paragraph [0101]), wherein the two-axis positioning slot is capable of allowing the positioning fastener to adjust the olecranon plate in both a proximal-distal direction (length direction extending along the longitudinal axis of 166) and a medial-lateral direction (width direction extending along the transverse axis of 166) (ramping action, Paragraph [0101], based on he type and size of the fastener inserted into 166, 166 is fully and structurally capable of allowing a fastener inserted therein to adjust the plate as recited in the functional language above).
Regarding Claim 9, O’Driscoll et al. discloses wherein the first sidewall and the second sidewall define waisted edge scallops (160, Figs. 4, 6 & 9, Paragraph [0100]).
Regarding Claim 11, O’Driscoll et al. discloses a system capable of treating a fracture in a proximal ulna bone, the system comprising: a bone plate (120/120R, Figs. 4-9, Paragraphs [0096-0104]) comprising: a curved head portion (distal portion 130, Figs. 4 & 9) capable of conforming (via bone-facing surface 124, Figs. 5 & 8) to an olecranon (Paragraph [0103]); a shaft portion (proximal portion 128, Figs. 4 & 9) extending from the curved head portion and capable of extending towards a distal end of an ulna (the distal portion 130 is fully and structurally capable of conforming to an olecranon and the proximal portion 128 is fully and structurally capable of extending towards a distal ulna when the plate 120/120R is placed on a patient’s ulna/elbow as recited in the functional language above); an upper surface (122, Figs. 5, 7 & 9) comprising the curved head portion and the shaft portion; a lower surface (124, Figs. 5 & 8) comprising the curved head portion and the shaft portion and capable of contacting the ulna (Paragraph [0103]); a first sidewall (right side wall 126, Figs. 7-8) extending between the upper surface and the lower surface along a first side (right side of 120/120R when viewing Fig. 7 which is the upper side wall 126 when viewing Figs. 4 & 9) of the plate; and a second sidewall (left side wall 126, Figs. 7-8) extending between the upper surface and the lower surface along a second side (left side of 120/120R when viewing Fig. 7 which is the lower side wall 126 when viewing Figs. 4 & 9) of the plate, wherein the shaft portion is curved with a left-handed (120, Paragraphs [0095, 0104]) or a right-handed curvature (120R, Paragraphs [0095, 0104]) and configured for a left ulna or a right ulna, respectfully (“Plate 120R is configured for fixing bone discontinuities in the distal-lateral right humerus of a body. Thus plate 120R arcs to the left, rather than the right as described above for plate 120. Plates 120 and 120R, and all other left- and right-handed plates described herein, may be related to each other by substantial or complete mirror-image symmetry.”); and a plurality of fasteners (fasteners/bone screws) capable of fastening the plate to the ulna (“For example, if used with fasteners, the openings may be sized to receive and effectively hold fasteners of different size, such as number 2.7, 3.5, and/or 4.0 bone screws, in order of increasing size. Generally, the smaller the opening, the smaller the screw, so that smaller openings allow relatively larger numbers of screws to be used with a given plate. Generally, also, the larger the plate, the larger the number of openings, so that larger plates allow relatively larger numbers of screws to be used.”, Paragraph [0080]).
Regarding Claim 12, O’Driscoll et al. discloses wherein the plate is left-handed (120, Fig. 4, Paragraph [0104]) and the first sidewall of the shaft portion (right side of 120 when viewing Fig. 7 which is the upper side wall 126 when viewing Fig. 4) is convex (Fig. 4) and the second sidewall of the shaft portion (left side of 120 when viewing Fig. 7 which is the lower side wall 126 when viewing Fig. 4) is concave (Fig. 4).
Regarding Claim 13, O’Driscoll et al. discloses wherein the plate is right-handed (120R, Fig. 9, Paragraph [0104]) and the first sidewall of the shaft portion (right side of 120R when viewing Fig. 7 which is the upper side wall when viewing Fig. 9) is concave (Fig. 9) and the second sidewall of the shaft portion (right side of 120R when viewing Fig. 7 which is the lower side wall when viewing Fig. 9) is convex (Fig. 9).
Regarding Claim 14, O’Driscoll et al. discloses a first opening in the head portion (right most round opening 134 when viewing Figs. 4 & 9) configured to receive a first fastener (fastener/bone screw, Paragraphs [0078-0082, 0096, 0101-102]) of the plurality of fasteners, wherein the first opening is capable of receiving the first fastener such that the first fastener extends toward a distal end of the ulna (“the openings may include tapered counterbores that bias a fastener toward (or away from) a bone discontinuity, for example, to provide compression.”, Paragraph [0079]).
Regarding Claim 15, O’Driscoll et al. discloses a plurality of second openings (left two round openings 134 when viewing Figs. 4 & 9) positioned distally of the first opening (distal end is at 142, proximal end is at 144, Fig. 4), wherein each second opening of the plurality of second openings is configured to receive a second fastener (fastener/bone screw, Paragraphs [0078-0082, 0096, 0101-102]) of the plurality of fasteners, wherein each second opening is capable of receiving a second fastener such that each second fastener extends towards one or a coronoid process of the ulna or an anterior cortex of the ulna (“the openings may include tapered counterbores that bias a fastener toward (or away from) a bone discontinuity, for example, to provide compression.”, Paragraph [0079]).
Regarding Claim 16, O’Driscoll et al. discloses a third opening (right most opening 132, Fig. 4) positioned distally of the plurality of second openings (distal end is at 142, proximal end is at 144, Fig. 4), wherein the third opening is configured to receive a third fastener (fastener/bone screw, Paragraphs [0078-0082, 0096, 0101-102]) of the plurality of fasteners, wherein the third opening is capable of receiving the third fastener such that the third fastener extends towards an olecranon process of the ulna (“the openings may include tapered counterbores that bias a fastener toward (or away from) a bone discontinuity, for example, to provide compression.”, Paragraph [0079]).
Regarding Claim 17, O’Driscoll et al. discloses a two-axis positioning slot (elongate opening 166, Figs. 4 & 9. 166 comprises a longitudinal axis in the length direction and a transverse axis extending in the width direction) positioned on the shaft portion configured to receive a positioning fastener (Paragraph [0101]), wherein the two-axis positioning slot is capable of allowing the positioning fastener to adjust the olecranon plate in both a proximal-distal direction (length direction extending along the longitudinal axis of 166) and a medial-lateral direction (width direction extending along the transverse axis of 166) (ramping action, Paragraph [0101], based on he type and size of the fastener inserted into 166, 166 is fully and structurally capable of allowing a fastener inserted therein to adjust the plate as recited in the functional language above).
Regarding Claim 19, O’Driscoll et al. discloses wherein the first sidewall and the second sidewall of the plate define waisted edge scallops (160, Figs. 4, 6 & 9, Paragraph [0100]).
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) 8 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Driscoll et al. (US PG Pub No. 2004/0116930) in view of Sixto JR, et al. (US PG Pub No. 2009/0118770).
Regarding Claims 8 & 18 as best understood, O’Driscoll et al. discloses the claimed invention as stated above in Claims 1 & 11, respectively, and further discloses a profile thickness of the plate along the shaft portion (thickness along 120/120R measured between 122 & 124, Fig. 5) which tapers along a proximal end of the head portion (proximal end is at 144, Fig. 1) and is capable of enabling closing of the fascia (“The thickness of lateral condyle plate 120 may vary along the length and/or across the width of plate 120.”, Paragraph [0099]).
O’Driscoll et al. does not disclose wherein the profile thickness of the plate is 2 mm along the shaft and tapers to less than 2.75 mm along the proximal end of the head portion. O’Driscoll does disclose in Paragraph [0099] that “Thinning may occur as a gradual taper from proximal to distal portions 128, 130 or at one or more fairly discrete positions along the length of the plate. A thinner distal portion may, for example, locally decrease the profile of the bone plate to minimize irritation. Alternatively, or in addition, proximal portion 128 may thin proximally near proximal end 142, to produce a tapered region 156 (see FIG. 5). Tapered region 156 may be produced, for example, by angled chamfers on outer surface 122 and/or inner surface 124, among others. Tapered region 156 may be useful, for example, to facilitate sliding proximal end 142 of plate 120 under soft tissue during positioning of the plate on bone. Alternatively, or in addition, thinning may occur transversely, along axes corresponding to width. For example, as shown in FIGS. 7 and 8, plate 120 thins or tapers towards center positions 157 from sides 126. In some embodiments, plate 120 may taper from center positions 157 toward sides 126. Transverse thinning, either thinning toward the sides and/or toward the center may occur in proximal and/or distal portions of the plate.”
Sixto, JR. et al. discloses an elongate bone plate for use on an arm bone (200, Figs. 9-11, Paragraph [0118]), wherein the plate comprises a curved head portion (231, Fig. 9) and a shaft portion (portion between bottom of 231 and end at 202, Figs. 9-10) extending from the curved head portion, an upper surface (208), a lower surface (210), a plurality of openings in the head portion (screw holes 230-234, Fig. 9) and a plurality of openings in the shaft portion (220-226, 236, Fig. 9), each configured to accept a fastener (Paragraph [0120]), and wherein a profile thickness of the plate (thickness measured between upper and lower surfaces (208 & 210, Fig. 10) along the shaft portion is 2 mm (Paragraph [0124]) and wherein “It is an important feature of the lateral plate that it is, overall, progressively stiffer from the distal end to the proximal end, corresponding to the loads experienced at respective portions of the plate.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the thickness of the shaft portion of the plate of O’Driscoll et al. to be 2 mm, tapering to less than 2 mm from the shaft portion to the proximal end of the head portion, as taught by Sixto, JR et al. in order to provide a low profile plate that has both sufficient structural strength and the ability to bend as needed to match a bone contour.
Claim(s) 10 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Driscoll et al. (US PG Pub No. 2004/0116930) in view of Patterson et al. (US Patent No. 7,137,987).
Regarding Claims 10 & 20, O’Driscoll et al. discloses the claimed invention as stated above in Claims 9 & 19, respectively, and further discloses wherein one of the waisted edge scallops of the first sidewall defines a first indentation (160 closest to 144 along right side wall 126, Fig. 4. Each scallop 160 defines an indentation along the right sidewall 126 as seen in Fig. 4, 6 & 9, Paragraph [0100]) and one of the waisted edge scallops of the second sidewall defines a second indentation (160 closest to 144 along left side wall 126, Fig. 4. Each scallop 160 defines an indentation along the left sidewall 126 as seen in Fig. 4, 6 & 9, Paragraph [0100]), wherein the first indentation and the second indentation are arranged between two adjacent fastener openings (134, Figs. 4 & 9) and are aligned with each other across the longitudinal axis of the plate such that they face each other (Figs 4 & 9).
O’Driscoll et al. does not disclose wherein the first indentation and the second indentation are aligned with a k-wire hole. O’Driscoll et al. does not disclose any k-wire holes along the plate.
Patterson et al. discloses an elongate bone plate (100< Figs. 1a-4) for use on an arm bone (Abstract), wherein a shaft portion of the plate comprises a plurality of bone screw openings (120, 121, Figs. 1a & 4), and wherein two adjacent bone screw openings (120 & 120) at the narrow end of the plate have a k-wire hole positioned centrally therebetween (Figs. 1a & 4), such that “200 is positioned and temporarily secured to the bone using K-wires” prior to insertion of bone screws into one of the bone screw openings (Col. 7).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the plate of O’Driscoll to add a k-wire hole centrally between adjacent bone screw openings in the head portion as taught by Patterson et al. such that the k-wire holes are aligned with the first and second indentations in order to provide the plate with a means for allowing the plate to be temporarily secured to the surgical site prior to final placement and insertion of the fasteners.
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