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 § 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)(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) 78-83, 85-89, 92, 96-98, 102, 104, 105 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sikora et al. (U.S. Publication No. 2013/0317506).
The applied reference has a common Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Sikora et al. substantially discloses all elements of claims 78-83, 85-89, 92, 96-98, 102, 104, 105 as can be seen in the figures and defined in the specification.
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) 78, 79, 83, 85-87, 92, 96, 102, 104, 105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith and Nephew, INC (WO2012/103459).
Smith and Nephew discloses a method of forming a microfracture in subchondral bone of a patient (page 5, line 2), the method comprising: disposing the microfracture apparatus (100) comprising a cannula (120) and a penetrator (106), the penetrator configured to pass at least partially through a longitudinal passageway of the cannula to a location adjacent to the subchondral bone (Figure 4); and advancing the penetrator relative to the cannula, substantially without rotation of the penetrator (page 8, paragraph beginning with, “In some implementations”). Smith and Nephew, INC fails to disclose that the penetration depth is greater than 5mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to perform the method so that the penetration depth is greater than 5mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 79, the method further comprising: repeating the steps of disposing and advancing to form a plurality of microfractures in the subchondral bone (Page 1, last line to page 2, lines 1, 2, “a series of channels can be formed).
Regarding claim 83, the cannula comprises a handle (136) having an indicator indicative of the position of the distal portion of the cannula. (the position of the handle itself is an indicator since it is known where the handle is in relation to the distal portion of the cannula).
Regarding claim 85, the penetrator is advanced manually (page 8, paragraph beginning with, “In some implementations”).
Regarding claim 86, the position of the second end of the cannula relative to the bone is substantially constant while advancing the penetrator (Figure 7A).
Regarding claim 87, the penetrator has an enlarged head (106a), and the penetration distance is limited by the enlarged head contacting the cannula.
Regarding claim 92, the distal end (114) of the penetrator is pointed (Figure 1B).
Regarding claim 96, the penetrator (106) includes a primary portion (most of the length of penetrator 106) and a penetration portion (tapered portion leading to 114) disposed between the primary portion and the distal end, the first transverse dimension is in the penetration portion, and a second transverse dimension is between the first transverse dimension and the primary portion (each section has a transverse dimension).
Regarding claim 102, the distal end (114) includes a pointed tip (Figure 1B) with a cross-sectional shape defined by a tip angle of 60 degrees or greater (it can be seen that the tip angle is substantially 90 degrees).
Regarding claim 104, the tip angle is greater than 90 degrees (page 6, Lines 1-2).
Regarding claim 105, the tip angle is greater than 120 degrees (page 6, Lines 1-2, since there is no upper limit to the statement, “in some cases, the angle alpha can be greater than 90 degrees, it is considered that all angles above 90 degrees, including those above 120 degrees are considered).
Allowable Subject Matter
Claims 106 and 107 allowed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose a method of microfracture surgery by disposing a cannula adjacent an articular surface, inserting a penetrator into the canula such that it is moved from a retracted position to an extended position to form a microfracture in the subchondral bone. The penetrator is removed from the cannula and a solution is injected through the cannula to the microfracture.
Conclusion
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/ANDREW YANG/Primary Examiner, Art Unit 3775