DETAILED ACTION
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 21 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.
Regarding claim 21, “the first aperture” lacks antecedent basis due to the change of dependency of claim 19 (from which claim 21 depends) from claim 17 to claim 18. For the purpose of examination, it is assumed claim 21 requires the step of reshaping the portion of the plate to include locating an aperture for receiving the second fastener at the greater tuberosity of the humerus, before the step of inserting the second fastener.
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.
Claims 13-15, 17, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2010/0262193 (Frigg) in view of U.S. Patent Application Publication No. 2020/0237418 (Courtney).
Regarding claim 13, Frigg discloses a surgical method comprising: inserting a first fastener (one of fasteners 116) into a bone (10) to a depth at which a head (118) of the first fastener is not in contact with an outer surface of the bone (see Figs. 3-5); placing an open-ended peripheral seat (104 or 204/205) of a plate (102 or 202) between the bone and a portion of the head of the first fastener (see Figs. 2 and 6 and paragraphs [0014]-[0019]), wherein the open-ended peripheral seat is defined by a portion of an outer perimeter of a body of the plate (see Figs. 1, 2, 6, and 9; each seat is defined by a portion of outer perimeter, such as lateral surface 216/218, of the plate), and the portion of the outer perimeter defining the open-ended peripheral seat has an open end (opening 112 or 212/213; see Figs. 1, 2, 6, and 9 and paragraphs [0014] [0018]) and an opposite terminal end (110 or 210, see paragraphs [0014] and [0018] and Figs. 1, 2, 6, and 9; see also marked-up Fig. 9 below), the terminal end sized to interact with a single fastener (see paragraphs [0016] and [0019] and Figs. 1, 2, 6, and 9; each terminal end sized to interact with a single fastener 116); and inserting the first fastener further into the bone to contact the head of the first fastener to the plate (see paragraphs [0016] and [0019] and Figs. 1, 2, 6, and 9).
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Further regarding claim 13, Frigg is silent regarding, after the step of placing, rotating the plate relative to the first fastener. However, Courtney discloses a surgical method that comprises placing a plate (600) on an outer surface of a bone (H) and inserting a first fastener (one of fasteners 130) into the bone (see paragraphs [0062] and [0139]), wherein, after the steps of placing the plate and inserting a first fastener, the plate is rotated relative to the first fastener (see paragraph [0062]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to include the step of rotating the plate relative to the first fastener after plate and first fastener have been placed in order to allow for positioning of the plate in an optimal position and final fixation via additional fastener without having to remove the first fastener.
Further regarding claim 13 and regarding claim 21, Frigg is silent regarding after the step of placing, reshaping a portion of the plate to conform with at least a portion of the outer surface of the bone so that the plate extends to a targeted anatomical location that is spaced from the first fastener (claim 13); wherein the step of reshaping the portion of the plate includes locating an aperture for receiving the second fastener at the greater tuberosity of the humerus, before the step of inserting the second fastener (claim 21). However, Courtney discloses a surgical method that comprises placing a plate (600) on an outer surface of a bone (H) and inserting a first fastener (one of fasteners 130) into the bone (see paragraph [0139]); after the steps of inserting and placing, reshaping a portion of the plate to conform with at least a portion of the outer surface of the bone so that the plate extends to a targeted anatomical location that is spaced from the first fastener (see paragraph [0139]: “Prior to placing some or all of the polyaxial screw 130 the tuberosity fracture plate 600 can be shaped to match the shape of the humerus H. The tuberosity fracture plate 600 can be bent along one or more of the bend zones 632 to create curvature along the longitudinal axis 648 that matches that of the particular patient's humerus H” (emphasis added); thus, the method includes after the insertion of some screws 130, reshaping the plate to conform with at least a portion of the outer surface of the bone so that the plate extends to a targeted anatomical location spaced from the screws 130 already placed), wherein the step of reshaping the portion of the plate includes locating an aperture for receiving a second fastener at the greater tuberosity of the humerus, before the step of inserting the second fastener (see paragraph [0139], reshaping of the plate prior to placement of some of the screws 130 can include locating an aperture for receiving a second fastener at the greater tuberosity of the humerus, before the step of inserting the second fastener; Figs. 29 and 30A show second screw hole 628 between bend zones 632 located at the greater tuberosity, see marked up-Fig. 29 below, e.g.). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Frigg to include the reshaping step suggested by Frigg in order to conform the shape of the plate to the shape of the bone of the patient, thus allowing for optimal fracture fixation (see Courtney, paragraph [0139]).
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Regarding claim 14, Frigg discloses wherein the step of placing includes moving the plate along an axis that is substantially perpendicular to a longitudinal axis of the first fastener (see paragraphs [0016]-[0019] and Figs. 1, 2, 6, and 9; plate is slid laterally over the bone such that each fastener 116 is received in the openings 112/212/213, the fasteners subsequently driven vertically along their longitudinal axis such that a head of each fastener engages a respective seat 104/204/205 of the plate; the lateral direction being substantially perpendicular to the vertical direction, which extends along the longitudinal axis of each fastener).
Regarding claim 15, Frigg discloses wherein the step of placing includes the terminal end of the open-ended peripheral seat contacting the first fastener (see paragraphs [0014], [0016], and [0019] and Fig. 1).
Regarding claim 17, Frigg discloses further comprising: inserting a second fastener (another fastener 116) through a first aperture (203) bounded within the perimeter of the body and into the bone (see Fig. 9 and paragraph [0018]). Additionally, Courtney suggests inserting a second fastener after reshaping of the plate into bone at the targeted anatomical location (see paragraph [0139]), and it would have been obvious to inserted the second fastener at the targeted anatomical location in order to fix the plate after it has been manipulated into a desired position by the user (see Courtney, paragraph [0139]).
Regarding claim 18, Frigg discloses further comprising: inserting a second fastener (another fastener 116) into the bone such that a head of the second fastener is not in contact with the outer surface of the bone (see Figs. 3-5); and manipulating the plate such that a second open-ended peripheral seat (another seat 104 or 204 or seat 205) of the plate is between the bone and a portion of the head of the second fastener (see Figs. 2 and 6 and paragraphs [0014]-[0019]), wherein the second open-ended peripheral seat is defined by a second portion (a different portion of lateral surface 214 or lateral surface 216, e.g.) of the outer perimeter of the body of the plate, and the second portion of the outer perimeter defining the second open-ended peripheral seat has an open end and an opposite terminal end (each seat 104/204/205 has an open end 112/212/213 and a terminal end 110/210; see also marked-up Fig. 9 above, e.g.), the terminal end sized to interact with a single fastener (see paragraphs [0016] and [0019] and Figs. 1, 2, 6, and 9; each terminal end sized to interact with a single fastener 116); and inserting the second fastener further into the bone to contact the head of the second fastener to the plate (see paragraphs [0016] and [0019] and Figs. 1, 2, 6, and 9). Additionally, Courtney suggests inserting a second fastener after rotating the plate (see paragraphs [0062] and [0139]), and it would have been obvious to insert the second fastener after rotation of the plate in order to fix the plate after it has been manipulated into a desired position by the user (see Courtney, paragraphs [0062] and [0139]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Frigg in view of Courtney, and further in view of U.S. Patent Application Publication No. 2013/0096630 (Lee).
Regarding claim 16, Frigg fails to disclose further comprising inserting an intramedullary nail within an intramedullary canal of the bone. However, Lee discloses a bone stabilization system (10) that includes both a bone plate (12) and an intramedullary nail (14), the intramedullary nail inserted within an intramedullary canal of a bone (see paragraph [0017]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method to include inserting an intramedullary nail into an intramedullary canal of the bone as suggested by Lee in order to provide added support, enhancing the structural strength of the system, and lowering the risk of failed surgery (see Lee, paragraph [0008]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Frigg in view of Courtney, and further in view of U.S. Patent Application Publication No. 2016/0310183 (Shah).
Regarding claim 19, Frigg discloses wherein: the bone is a humerus (see paragraph [0018]); and the step of inserting the second fastener includes locating the second fastener in a location on the humerus (see paragraphs [0018] and [0019]). Frigg is silent regarding the second fastener location being posterior to a location at which the first fastener is located. However, Shah discloses a method of installing a bone plate on a humerus (see Abstract), wherein a second fastener (46) is inserted in a location on the humerus that is posterior to a location in which first fastener (26) is inserted (see Figs. 5A, 5B, and 7A). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Frigg to have the second fastener located posterior to the first fastener in order to allow the screws to obtain fixation in multiple planes (see Shah, paragraph [0022]).
Response to Arguments
Applicant’s arguments with respect to claims 13-19 and 21 have been considered but are moot in view of the new grounds of rejection.
Additionally, Applicant argues on page 5 of the Remarks that Courtney does not teach a step of rotating its plate relative to any fastener after placing its plate over the bone. The examiner disagrees, and cites to paragraph [0062] of Courtney which teaches such rotation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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