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 7 objected to because of the following informalities: lines 1-2 recite “its largest opening position...” The Examiner suggests amending the claim to avoid using “its.” Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,232,722 B2 in view of Burn (US 2007/0276395 A1).
Regarding claim 1, US 12,232,722 B2 discloses suture passing drill, comprising: a proximal end and a distal end with an elongated shaft extending therebetween, the elongated shaft having a first portion with a first diameter (claim 1); a wire loop extending from the proximal end of the elongated shaft (claim 1); a drill tip at the distal end of the elongated shaft (claim 1); a narrow portion on the elongated shaft (claim 1). However, US 12,232,722 B2 fails to disclose the narrow portion having a second thickness when viewed from a side and a second width when viewed from a top, the narrow portion proximally adjacent relative to the drill tip; and wherein the second thickness is smaller than the first diameter and the second width is larger than the first diameter.
In the same field of endeavor, Burn teaches (Figures 1-3) a suture passing drill, comprising: a proximal end and a distal end with an elongated shaft (2) extending therebetween, the elongated shaft having a first portion with a first diameter (d); a drill tip (6) at the distal end of the elongated shaft; a narrow portion (3) on the elongated shaft having a second thickness (x) when viewed from a side (Figure 2) and a second width (w) when viewed from a top (Figure 1), the narrow portion proximally adjacent relative to the drill tip (6); and wherein the second thickness is smaller than the first diameter (d) and the second width is larger than the first diameter (paragraph 0015).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suture passing drill disclosed by US 12,232,722 B2 such that the narrow portion on the elongate shaft has a second thickness when viewed from a side and a second width when viewed from a top, the narrow portion proximally adjacent relative to the drill tip, wherein the second thickness is smaller than the first diameter and the second width is larger than the first diameter, as taught by Burn. This modification produces a cut through bone that is circular and has a final diameter equal to the diagonal y of the drill tip, i.e. slightly greater than the maximum width of the drill tip. This means that once the hole is cut the drill may be extended further through the hole without the shaft enlarging or damaging the hole (Burn, paragraph 0017).
Regarding claim 2, US 12,232,722 B2 as modified by Burn teaches that the drill tip comprises a leading edge extending at an angle from a surface of the elongated shaft (claim 2).
Regarding claim 3, US 12,232,722 B2 as modified by Burn teaches the leading edge extends about 25° from the surface of the elongated shaft (claim 3).
Regarding claim 4, US 12,232,722 B2 as modified by Burn teaches the drill tip comprises three cutting edges (claim 4).
Regarding claim 5, US 12,232,722 B2 as modified by Burn teaches one of the three cutting edges extends 120° relative to another of the three cutting edges (claim 5).
Regarding claim 6, US 12,232,722 B2 as modified by Burn teaches the narrow portion is coined into the elongated shaft (claim 6).
Regarding claim 7, US 12,232,722 B2 as modified by Burn teaches the wire loop comprises a third diameter at its largest opening position, which is larger than the first diameter (claim 7).
Regarding claim 8, US 12,232,722 B2 as modified by Burn teaches the wire loop is composed of nitinol (claim 8).
Regarding claim 9, US 12,232,722 B2 as modified by Burn teaches the elongated shaft is composed of stainless steel (claim 9).
Regarding claim 10, US 12,232,722 B2 as modified by Burn teaches a length of suture attached to the wire loop (claim 10).
Regarding claim 11, US 12,232,722 B2 as modified by Burn teaches the length of suture is woven through an anchoring body (claim 11).
Regarding claim 12, US 12,232,722 B2 as modified by Burn teaches the anchoring body is an all-suture button (claim 12).
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 1, 2, and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Denove et al. (US 2010/0152752 A1) (“Denove”) in view of Burn (US 2007/0276395 A1).
Regarding claim 1, Denove discloses (Figure 1-12) a suture passing drill (100; Denove discloses the K-wire is drilled directly into bone, paragraph 0023), comprising: a proximal end and a distal end with an elongated shaft (10) extending therebetween, the elongated shaft having a first portion (10a) with a first diameter; a wire loop (20) extending from the proximal end of the elongated shaft; and a drill tip (15) at the distal end of the elongated shaft. Denove fails to disclose a narrow portion on the elongated shaft having a second thickness when viewed from a side and a second width when viewed from a top, the narrow portion proximally adjacent relative to the drill tip, wherein the second thickness is smaller than the first diameter and the second width is larger than the first diameter.
In the same field of endeavor, Burn teaches (Figures 1-3) a suture passing drill, comprising: a proximal end and a distal end with an elongated shaft (2) extending therebetween, the elongated shaft having a first portion with a first diameter (d); a drill tip (6) at the distal end of the elongated shaft; a narrow portion (3) on the elongated shaft having a second thickness (x) when viewed from a side (Figure 2) and a second width (w) when viewed from a top (Figure 1), the narrow portion proximally adjacent relative to the drill tip (6); and wherein the second thickness is smaller than the first diameter (d) and the second width is larger than the first diameter (paragraph 0015).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suture passing drill disclosed by Denove to include a narrow portion on the elongated shaft having a second thickness when viewed from a side and a second width when viewed from a top, the narrow portion proximally adjacent relative to the drill tip, wherein the second thickness is smaller than the first diameter and the second width is larger than the first diameter, as taught by Burn. This modification produces a cut through bone that is circular and has a final diameter equal to the diagonal y of the drill tip, i.e. slightly greater than the maximum width of the drill tip. This means that once the hole is cut the drill may be extended further through the hole without the shaft enlarging or damaging the hole (Burn, paragraph 0017).
Regarding claim 2, Denove as modified by Burn teaches (Denove, Figure 2(c)) the drill tip comprises a leading edge extending at an angle from a surface of the elongated shaft.
Regarding claim 6, Denove as modified by Burn teaches the narrow portion is coined into the elongated shaft.
The claimed phrase "the narrow portion is coined into the elongated shaft" is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. § 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. "[E]ven though product- by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Denove as modified by Burn is silent regarding how the narrow portion is formed. However, the combined teaching teaches that the narrow portion is formed of surgical steel (Denove, paragraph 0028; Burn, paragraph 0014). Thus, since the combined teaches that the drill is formed of surgical steel and the narrow portion on the elongated shaft has a second thickness when viewed from a side and a second width when viewed from a top, the narrow portion proximally adjacent relative to the drill tip, and wherein the second thickness is smaller than the first diameter and the second width is larger than the first diameter, it appears that the product taught by Denove in view of Burn would be the same or similar as that claimed.
Regarding claim 7, Denove as modified by Burn teaches (Denove, Figures 1 and 3(b)) that the wire loop (20) comprises a third diameter at its largest opening position, which is larger than the first diameter.
Regarding claim 8, Denove as modified by Burn teaches (Denove, Figure 1) the wire loop (20) is composed of nitinol (Denove, paragraph 0029).
Regarding claim 9, Denove as modified by Burn teaches the elongated shaft (20) is composed of stainless steel (Denove, paragraph 0028).
Regarding claim 10, Denove as modified by Burn teaches (Denove, Figures 4-12) a length of suture (151) attached to the wire loop (Denove, paragraph 0038).
Regarding claim 11, Denove as modified by Burn teaches (Denove, Figures 4-12) that the length of suture (151) is woven through an anchoring body (Denove, paragraph 0038).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Denove et al. (US 2010/0152752 A1) (“Denove”) in view of Burn (US 2007/0276395 A1) as applied to claim 2 above, and further in view of Bobst et al. (US 5,788,699) (“Bobst”).
Denove as modified by Burn teaches the invention substantially as claimed in that the drill tip comprises a leading edge extending at an angle from a surface of the elongated shaft (see claim 2 above). However, the combined teaching fails to teach that the leading edge extends about 25 degrees from the surface of the elongated shaft.
In the same field of endeavor, Bobst teaches (Figures 1 and 2) a drill comprising a drill tip (13) comprising a leading edge (Figure 2) extending at an angle (α/2) from a surface (17) of an elongated shaft. Bobst teach that α is at most 55-65 degrees. Therefore, α/2 is approximately 27.5-32.5 degrees. Bobst teaches that the taper angle of the drill tip is a result effective variable and can be optimized to achieve minimal temperatures at the drill tip (Column 1, lines 65-67). Bobst teaches that optimizing the taper angle results in a drill tip that has proven optimal with respect to both efficiency of drilling on one hand, and a low heat production on the other (Column 3, lines 30-32). It appears one having ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in modifying the angle that the leading edge extends, as it involves only adjusting dimensions of the device.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the leading edge taught by Denove in view of Burn to extend about 25 degrees from the surface of the elongated shaft, as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, the Applicant fails to establish criticality of the claimed angle of about 25 degrees, stating only that the angle "can vary within the range of 10-30 degrees" (see paragraphs 0023-0024 of Applicant's disclosure).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Denove et al. (US 2010/0152752 A1) (“Denove”) in view of Burn (US 2007/0276395 A1) as applied to claim 1 above, and further in view of Jolly et al. (US 2010/0217315 A1) (“Jolly”).
Regarding claims 4 and 5, Denove as modified by Burn teaches the invention substantially as claimed. However, the combined teaching fails to teach that the drill tip comprises three cutting edges, wherein one of the three cutting edges extends 120 degrees relative to another of the three cutting edges.
Jolly teaches (Figure 5b) that a drill tip (215) can comprise three cutting edges (paragraph 0044), wherein one of the three cutting edges extends 120 degrees (Figure 5b) relative to another of the three cutting edges.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the drill tip taught by Denove in view of Burn above to comprises three cutting edges, wherein one of the three cutting edges extends 120 degrees relative to another of the three cutting edges, as further taught by Jolly. This modification would provide a drill tip configuration with cutting edges suitable for drilling a socket or tunnel through bone in a procedure such as an ACL reconstruction (Jolly, paragraph 0050). Further, modifying the configuration of the tip/cutting edges of the drill to improve performance, such as the balance and the strength of the drill tip would have been obvious to one having ordinary skill in art before the effective filing date of the claimed invention.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Denove et al. (US 2010/0152752 A1) (“Denove”) in view of Burn (US 2007/0276395 A1) as applied to claim 11 above, and further in view of Santangelo et al. (US 2014/0243893 A1) (“Santangelo”).
Regarding claim 12, Denove as modified by Burn the invention substantially as claimed. However, the combined teaching fails to teach that the anchoring body is an all-suture button.
In the same field of endeavor, Santangelo teaches (Figures 1-3B) a resilient anchor (100) in the form of button with apertures (111-1, 111-2) formed through a body (102) of the button. Santangelo teaches that the body is formed of a resilient material, such as suture (paragraph 0020). The button is configured to receive a suture (121) through the apertures. The button engages a surgical surface (144) such as bone and the suture ends are secured by any suitable means away from the button (paragraph 0024). The button has length greater than a diameter of the surgical aperture defined by the bone tunnel (160), and therefore remains fixed, forming a "T" engagement with the suture (121) against the bone (144).
Denove in view of Burn teaches the claimed invention except that Denove in view of Burn does not teach that the anchoring body is an all-suture button. Denove discloses buttons formed of titanium, stainless steel, PolyEtherEther-Ketone (PEEK) or Poly-L Lactic Acid (PLLA). Santangelo shows that an all-suture button is an equivalent structure known in the art for securing a suture relative to a bone tunnel. Therefore, because the buttons disclosed by Denove and the all-suture button taught by Santangelo were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the all-suture button taught by Santangelo for the buttons taught by Denove in ivew of Burn. Substitution of one known element (an all-suture button) for another element (the buttons disclosed by Denove) providing the same function to yield predictable results (securing the suture relative to the bone tunnels) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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