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 § 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) 1 and 4-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nallakrishnan et al. (US 2016/0374854) in view of Marler (US 2011/0306951).
Regarding claim 1, Nallakrishnan discloses a surgical apparatus, said apparatus comprising:
a hollow cannula (Fig. 2, cannula 12) having a proximal end (Fig. 2, proximal end 14), a distal end (Fig. 2, distal end 16), and defining an interior passage (Fig. 2,interior passage 18) extending from said proximal end (Fig. 2, proximal end 14) to said distal end (Fig. 2, distal end 16), said interior passage (Fig. 2, interior passage 18) defining a central cannula axis (Fig. 2, interior passage 18 defines a central axis; ¶(0044]), said cannula (Fig. 2, cannula 12) including at least one locking aperture (Fig. 3, annular retention groove 32) extending transversely relative to said central cannula axis (Fig. 3, annular retention groove 32 extends transversely relative to the defined central axis); and
a hollow tip (Fig. 3, aspiration lip 20) having a base portion (Fig. 3, sleeve portion 28) affixed with the distal end (Fig. 2, distal end 16) of said cannula (Fig. 2, cannula 12), said base portion (Fig. 3, sleeve portion 28) including at least one projection (Fig. 3, annular collar 34 defines an annular abutment surface; ¶(0043]) extending within said at least one locking aperture (Fig. 3, annular retention groove 32; ¶[0043]) of said cannula (Fig. 2, cannula 12) for maintaining said tip (Fig. 3, aspiration tip 20) in position at said distal end (Fig. 2, distal end 16) of said cannula (Fig. 3, the abutment surface is in engagement with a retention portion of cannula 12 for maintaining the aspiration tip 20 in position on the distal end 16 of the aspirating cannula 12; ¶(0043]), said tip (Fig. 3, aspiration tip 20) having an exposed end portion (Fig. 3, body portion 24) extending beyond said distal end (Fig. 2, distal end 16) of said cannula (Fig. 2, cannula 12) and defining at least one port (Fig. 3, aspiration port 26) in fluid communication with the interior passage (Fig. 3, aspiration port 26 is in fluid communication with the interior passage 18; ¶[0040]) defined by said cannula (Fig. 2, cannula 12).
Nallakrishnan does not explicitly disclose a base portion affixed within the distal end of said cannula.
Marler is in the field of a surgical cannula (¶(0001]) and teaches an apparatus (Fig. 1, cannula 100), a tip (Fig. 15, tip 104) having a base portion (Fig. 15, proximal end 116; ¶(0051]) affixed within the distal end (Fig. 15, distal end 112) of said cannula (Fig. 1, Fig. 15, a portion of the proximal end 116 of the cannula tip 104 is inserted into the bore 108 at the distal end 112 of the tubular shaft 102; ¶(0051]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Nallakrishnan to include insertion of the tip as taught by Marler, the motivation being to streamline the outer surface of the cannula, thereby facilitating insertion of the cannula in tissue.
Regarding claim 4, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1, Marler further teaches wherein said at least one port (Fig. 3, aperture 134) has a stadium shape (Fig. 3, aperture 134 has a stadium shape).
Regarding claim 5, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1, Nallakrishnan further teaches wherein said cannula includes a pair of opposing locking apertures (Fig. 3, 30) extending transversely relative to said central cannula axis and said base portion includes a pair of projections received therein (Fig. 3-4, where the parts 30 are on both sides of the cannula axis and receive part 34 within the area to create a lock with the projections).
Regarding claim 6, the combination of Nallakrishnan and Maler teaches the surgical apparatus in accordance with claim 1, Nallakrishnan further teaches wherein said at least one port (Fig. 5, port 26) and said at least one projection (Fig. 5, the abutment surface of collar 34) of said tip (Fig. 5, tip 20) are aligned (Fig. 5, port 26 and the abutment surface are aligned).
Regarding claim 7, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1, Marler further teaches wherein said exposed end portion (Fig. 15, tip 104 defines an exposed end portion) of said tip (Fig. 15, tip 104) includes a flange (Fig. 15, tip 104 defines a flange) surrounding a central tip axis (Fig. 15, axis 114).
Regarding claim 8, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1, Nallakrishnan further teaches wherein said exposed end portion (Fig. 3, body portion 24) of said lip (Fig. 3, tip 20) defines an outer tip surface (Fig. 3, body portion 24 defines an outer lip surface.
Nallakrishnan does not explicitly disclose said cannula defines an outer cannula surface which is coextensive with said outer lip surface.
Marler teaches an apparatus (Fig. 1, cannula 100), said cannula (Fig. 1, cannula 100) defines an outer cannula surface (Fig. 15, tubular shaft 102 defines an outer surface) which is coextensive with said outer tip surface (Fig. 15, the outer surface of tubular shaft 102 is coextensive with the outer surface of lip 104 ).
Regarding claim 9, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1, Nallakrishnan further teaches wherein said exposed end portion (Fig. 3, body 24) of said tip (Fig. 3, tip 20) tapers radially inwardly to a rounded terminal end (Fig. 3, body 24 tapers radially inwardly to a rounded terminal end).
Regarding claim 10, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1, Nallakrishnan further teaches wherein said exposed end portion (Fig. 3, body 24) of said tip (Fig. 3, tip 20) includes a semi-circular terminal end (Fig. 3, lip 20 defines a semi-circular terminal end).
Regarding claim 11, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1 The primary embodiment of Nallakrishnan does not explicitly disclose the surgical apparatus in combination with an infusion sleeve mounted around said cannula, said infusion sleeve having a proximal end and a distal end terminating axially inwardly of said at least one port of said tip, said distal end of said infusion sleeve including at least one infusion port.
A secondary embodiment of Nallakrishnan discloses an apparatus (Fig. 15, apparatus 200), the surgical apparatus (Fig. 15, apparatus 200) in combination with an infusion sleeve (Fig. 15, irrigation sleeve 300) mounted around said cannula (Fig. 15, cannula 212), said infusion sleeve (Fig. 15, irrigation sleeve 300) having a proximal end (Fig. 15, proximal end 302) and a distal end (Fig. 15, distal end 304) terminating axially inwardly of said at least one port (Fig. 15, port 226) of said tip (Fig. 15, irrigation sleeve 300 terminates axially inwardly of the port 226 of the tip 220; ¶[0053]), said distal end (Fig. 15, distal end 304) of said infusion sleeve (Fig. 15, irrigation sleeve 300) including at least one infusion port (Fig. 15, irrigation ports 310, 312).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus as taught by the primary embodiment of Nallakrishnan to include the irrigation sleeve as taught by the secondary embodiment of Nallakrishnan, the motivation being to facilitate provision of irrigation fluid to an operation site.
Regarding claim 12, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1 wherein said cannula (Fig. 1, cannula 12) is formed with at least one bend between said proximal end and said distal end (said aspiration cannula is formed with at least one bend between said proximal and distal ends; claim 10).
Regarding claim 13, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1 wherein said tip (Fig. 5, aspiration tip 20) is formed from an elastomer (Fig. 5, aspiration tip 20 is formed from a silicone elastomer; ¶[0043]).
Regarding claim 14, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1 wherein said exposed end portion (Fig. 5, body portion 24) of said tip (Fig. 5, tip 20) defines an outer tip surface (Fig. 5, body portion 24 defines an outer tip surface) that is roughened (the body portion of the aspiration tip defines a roughened surface; ¶[0017]).
Regarding claim 15, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1, however, the combination does not explicitly teach wherein said tip is insert molded at said distal end of said cannula.
This is a product by process claim and since it is held that "[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). Additionally, art such as McNeill (US 2014/0018691) and Zelkovich et al. (US 2010/270702) teach insert molding a tip with a cannula and as such it is not a novel process but a well-known procedure in the art to design a device in this way.
Regarding claim 16, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1 in combination with a handpiece (hand piece; ¶[0039]) connected to a vacuum source (vacuum device; ¶[0039]).
Regarding claim 17, discloses the surgical apparatus in accordance with claim 1, further disclosing in combination with a handpiece (hand piece; ¶[0039]).
The primary embodiment of Nallakrishnan does not explicitly disclose a handpiece connected to an infusion fluid supply source.
A secondary embodiment of Nallakrishnan discloses an apparatus (Fig. 15, apparatus 200), the surgical apparatus (Fig. 15, apparatus 200) in combination with a handpiece (Fig. 15, hand piece 400) connected to an infusion fluid supply source (Fig. 15, hand piece 400 is connected to an irrigation fluid supply; ¶[0053]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus as taught by the primary embodiment of Nallakrishnan to include the irrigation source.
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Nallakrishnan et al. (US 2016/0374854) in view of Marler (US 2011/0306951) as applied to claim 1 above, and further in view of Taufig (US 2008/0188833).
Regarding claim 2, the surgical apparatus in accordance with claim 1, does not explicitly disclose wherein said at least one port defined by said exposed end portion of said tip extends transversely relative to said central cannula axis.
Taufig is in the field of a suction cannula (¶[0001]) and teaches an apparatus (Fig. 1, cannula 10), wherein said at least one port (Fig. 1, suction apertures 20) defined by said exposed end portion (Fig. 1, suction tube 12 defines an exposed end portion) of said tip (Fig. 1, suction tube 12) extends transversely relative to said central cannula axis (Fig. 1, the suction apertures 20 extend transversely relative to a central axis defined by suction tube 12 and closure tube 14).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Nallakrishnan to include the transverse suction apertures as taught by Taufig, the motivation being to maximize suction around the cannula (Abstract, ¶[0007] from Taufig).
Regarding claim 3, the combination of Nallakrishnan and Marler teaches the surgical apparatus in accordance with claim 1, does not explicitly disclose wherein said at least one port has a form of a pair of opposing ports.
Taufig is in the field of a suction cannula (¶[0001]) and teaches an apparatus (Fig. 1, cannula 10), wherein said at least one port (Fig. 1, suction apertures 20) has a form of a pair of opposing ports (Fig. 1, suction apertures 20 define a pair of opposing ports). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the apparatus of Nallakrishnan to include at least one port which has a form of a pair of opposing ports as taught by Taufig, the motivation being to have mechanical cleaning and vapor-sterilization made easier and by improved.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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