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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-6 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites: “an elongated protective portion that is inserted into the first bone hole” in lines 4-5. Examiner suggests amending so that the claim does not positively recite the bone including language similar to, “an elongated protective portion that is configured to be inserted into the first bone hole,” to overcome the rejection.
Claim 5 recites: “a first portion that is disposed on a front side of the tibia” in lines 3-4. Examiner suggests amending so that the claim does not positively recite the tibia including language similar to, “a first portion that is configured to be disposed on a front side of the tibia,” to overcome the rejection.
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 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a “twist position” in line 13. It is unclear what orientation/spatial relationship a “twist” refers. [0051] and [0059] of the specification do not appear to further define a “twist position.” Appropriate clarification and correction is required.
Claim 1 recites the limitation "the protective portion" in lines 14 and 16. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this protective portion refers to the elongated protective portion of line 4. Appropriate clarification and correction is required throughout claims 1-6.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S Patent No. 7,842,042 to Reay-Young et al. in view of U.S. Patent Pub. No. 2018/0153566 to Fallin et al.
As to Claim 1, Reay-Young discloses a guide device (20, Fig. 4) that guides a drill that drills a second bone hole (52) in a bone (15) in which a first bone hole (50) is formed (Col. 3, Lines 12-39). The guide device comprises an elongated protective portion (22, Col. 3, lines 51-61) that is inserted into the first bone hole and that defines, in an interior of the first bone hole (Col. 3, Lines 12-39), a pathway (along 40) that extends in a longitudinal direction of the first bone hole (seen along 50, Fig. 7), a guide portion (32) that has a guide hole (receiving 24, Fig. 4) that specifies a guide axis (along 42, seen in Fig. 4) and that guides the drill (46) passing through the guide hole along the guide axis (Col. 3, Lines 63-67 – Col. 4, Lines 1-6), and an arm portion (26) that connects the protective portion with the guide portion (seen in Figs. 4 and 7, Col. 3, Lines 40-50), wherein the guide axis (along 42) is disposed at a twist position (orientation seen in Figs. 4-7, Col. 3, Lines 62-67 – Col. 4, Lines 1-6) with respect to the protective portion (22), and the drill (46) guided along the guide axis (along 42) passes through a position at which the drill does not interfere with the protective portion and the pathway (seen in Fig. 7, Col. 4, Lines 17-39).
As to Claim 2, Reay-Young discloses a guide device wherein in the guide device, there are a top-to-bottom direction, a left-to-right direction, and a front-to-rear direction (see annotated Fig. 7, below) that substantially correspond to a longitudinal direction, a left- to-right direction, and a front-to-rear direction of a tibia (15), respectively (seen in Fig. 7), the protective portion (22) extends in the front-to-rear direction (seen in Fig. 7, Col. 3, Lines 22-39) the guide portion (32) is disposed, with respect to the protective portion (22), on a side corresponding to an inside of the tibia in the left-to-right direction of the guide device (orientation seen in Fig. 7), and, the guide axis (along 42) intersects the protective portion in plan view viewed in the top-to-bottom direction (at point of convergence, Fig. 7, Col. 3, Lines 12-21).
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As to Claim 3, Reay-Young discloses a guide device wherein the protective portion (22) has a channel (40) that extends in a longitudinal direction of the protective portion over an entire length of the protective portion (Col. 3, Lines 51-62), and the channel (40) opens on an outside surface of the protective portion on an opposite side from the guide axis (seen in Figs. 4, 7, Col. 3, Lines 51-67 – Col. 4, Lines 1-6).
As to Claim 4, Reay-Young discloses a guide device wherein the protective portion (22), the guide portion (32), and the arm portion (26) are formed from separate members (Figs. 4-7, Col. 3, Lines 12-21), the protective portion (22) is attached to the arm portion (26) in a detachable manner (Col. 3, Lines 22-39), and the guide portion (32) is attached to the arm portion in a detachable manner (Col. 3, Lines 40-50).
As to Claim 5, Reay-Young discloses a guide device wherein the arm portion (26) has a first portion that is disposed on a front side of the tibia (seen in Fig. 7) and to which the protective portion (22) is attached in a front-to-rear direction of the tibia (15, Col. 3, Lines 22-39), and a second portion (28) that extends in an arc-like manner or a substantially arc-like manner (seen in Figs. 4 and 7( inward from the front side of the tibia (15) and to which the guide portion (32) is attached (via 26), and the guide portion (32) is supported by the second portion (28) so as to be movable in an extension direction of the second portion (Col. 3, Lines 12-21) and rotatable about a rotation axis (about 38) that intersects a plane defined by the second portion (Col. 3, Lines 40-50).
As to Claim 6, Reay-Young discloses a guide device wherein the protective portion (22) has a first portion (towards ref. 44, Fig. 4) on a basal-end side and a second portion (towards ref. 40, Fig. 4) on a distal-end side, and the second portion is thinner than the first portion (seen in Fig. 4) and an outside surface on a side of the guide axis (along 42) in the second portion is offset in a direction away from the guide axis with respect to an outside surface on a side of the guide axis in the first portion (offset due to enlarged diameter section at proximal end of 22, Figs. 4-7).
As to Claims 1-6, Reay-Young discloses the claimed invention except for wherein a first suture passes through a pathway, the suture passing through a channel that extends in a longitudinal direction of the protective portion over an entire length of the protective portion
Fallin discloses a guide device (100, Fig. 1, [0042]) including wherein a first suture passes (via 136) through a pathway (through 110, [0045], Figs. 1 and 2), the suture passing through a channel (through tunnel member 110, [0047]) that extends in a longitudinal direction of the protective portion (110) over an entire length of the protective portion (Figs. 1 and 2, [0045, 0047]) in order to allow for a suture to pass through the device to bone to form a transosseous attachment to the bone [0003, 0041].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the guide device of Reay-Young with the suture modification of Fallin in order to allow for a suture to pass through the device to bone to form a transosseous attachment to the bone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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