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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0057092 to Peterson (“Peterson”) in view of USPN 9,833,560 to Reichert et al (“Reichert”).
Regarding claim 1 and 9, Peterson discloses (see Figs. 1 and 3) a medical treatment system (10) comprising: a medical treatment instrument (14); a console (12) configured to supply fluid to said medical treatment instrument in a defined operating mode of the medical treatment system (see para. [0006] stating, “One embodiment provides twin bore ophthalmologic tubing for use with a fluidics cassette and a handpiece of an ophthalmologic system. The ophthalmologic system can be a phacoemulsification, liquefaction, or other type of surgical system utilizing irrigation/aspiration handpieces. The twin bore ophthalmologic tubing can include a first sterilized tube and a second sterilized tube joined along substantially the length of the twin bore ophthalmologic tubing. The tubes can have ends adapted for connection to the fluidics cassette and to the handpiece.” and para. [0021] stating, “As surgical personnel operate on patient 42 using handpiece 14 to perform certain delicate techniques (e.g., phacoemulsification, liquefaction or other methods of extraction of cataracts)…”); a tube (40) for feeding an irrigation fluid from said console to said medical treatment instrument and for discharging an aspiration fluid from said medical treatment instrument to said console (see para. [0020] stating, “With reference now to FIG. 3, one embodiment of twin bore ophthalmologic tubing 40 is illustrated. Patient 42 is also illustrated. Twin bore ophthalmologic tubing 40 can be used with phacoemulsification, liquefaction, or other surgical systems which utilize irrigation/aspiration handpieces. Twin bore ophthalmologic tubing 40 includes irrigation tube 46, aspiration tube 48…”); said tube including a first channel (channel inside irrigation tube 46) for feeding an irrigation fluid from said console to said medical treatment instrument; said tube further including a second channel (channel inside aspiration tube 48) for discharging the aspiration fluid from said medical treatment instrument to said console; said first channel and said second channel being arranged in parallel next to each other in a direction of longitudinal extent of the tube (see Fig. 3); said first channel having a first wall (irrigation tube 46 is disclosed as a tube to transfer fluid; therefore, it necessarily includes a tube wall) including a first material having a first hardness (see para. [0025] statin, “In some embodiments, end portions 52 and 56 of twin bore ophthalmologic tubing 40 can be made from materials having relatively low hardness. End portions 52 and 56 can therefore cause little or no reactions as surgical personnel navigate handpiece 14 about various surgical sites. Accordingly, end portions 52 and 56 can provide high navigability of handpiece 14.” (emphasis added)); said second channel having a second wall (aspiration tube 48 is disclosed as a tube to transfer fluid; therefore, it necessarily includes a tube wall) including a second material having a second hardness (see para [0025] stating, “Other portions 54 of twin bore ophthalmologic tubing 40 can be made of materials having relatively high hardness thereby permitting no, or little, overall compliance of irrigation tube 46 and aspiration tube 48.” (emphasis added)); said second hardness being greater than said first hardness (see para [0025] and annotated Fig 4 below);
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said tube being formed from two individual tube elements including a first tube element for said first channel and a second tube element for said second channel ([0020] With reference now to FIG. 3, one embodiment of twin bore ophthalmologic tubing 40 is illustrated. Patient 42 is also illustrated. Twin bore ophthalmologic tubing 40 can be used with phacoemulsification, liquefaction, or other surgical systems which utilize irrigation/aspiration handpieces. Twin bore ophthalmologic tubing 40 includes irrigation tube 46, aspiration tube 48, proximal end 50, distal end 51, proximal end portion 52, mid portion 54, and distal end portion 56. Irrigation tube 46 and aspiration tube 48 may be joined to each other (or formed together via extrusion, injection molding, etc.) along substantially the length of twin bore ophthalmologic tubing 40.); said first tube element and said second tube element being welded or adhesively bonded in a connection region (see para. [0020] stating, “Irrigation tube 46 and aspiration tube 48 may be joined to each other (or formed together via extrusion, injection molding, etc.) along substantially the length of twin bore ophthalmologic tubing 40.” (emphasis added)); and, wherein a difference in hardness between said first hardness and said second hardness is at least 10 ShA and at most 15 ShA (see para. [0026] stating, “In some embodiments, end portions 52 and 56 can have a hardness of about 60 shore A to about 70 shore A while mid portion 54 can have a hardness of about 80 shore A to about 90 shore A.”). It is noted that the different between 70-80 shore A is 10ShA.
Peterson meets the claim limitations as described above but does not specifically disclose welding or adhesively bonding the first and second tube elements. However, Peterson does disclose in para. [0020] stating, “Irrigation tube 46 and aspiration tube 48 may be joined to each other (or formed together via extrusion, injection molding, etc.) along substantially the length of twin bore ophthalmologic tubing 40.” (emphasis added) Therefore, it would have been obvious to join the irrigation tube and aspiration tube as taught by Peterson by either welding or adhesively bonding since one skilled in the art would have known that either welding or using adhesive is a suitable techniques/materials for the purpose of joining medical tubing. Additionally, it would have been obvious to adhesively bond the first and second tube elements in light of Reichart which shows multiple parallel tubing sets (400,416,418) being attached to one another using another material (460). See Fig. 5b and col. 20 ll. 29-47 stating, “The IV set system of FIG. 4b is shown as comprising a primary IV set 400 and two secondary IV sets 416 and 418 that are separably and physically joined together. In this particular example, the IV set system comprises a discontinuous type of attachment of the primary IV set 400 and the secondary lines 416 and 418 at fused locations 460 along the respective tubular flow line structures. In other words, discontinuous, isolated attachment members at fused locations 460 function to physically join the IV sets together. These attachment members at the various locations 460 are considered to be discontinuous as they are separated by unconnected segments of the tubular flow line structures. The isolated points of attachment or fused locations 460 cart comprise material integrally formed from the same material as the IV lines, or they can comprise a different material. In any event, the attachment members at fused locations 460 can comprise material that can facilitate the joining of one or more IV sets, and the selective separation or peeling away of these.” (emphasis added)
At the time of filing, it would have been obvious to one of ordinary skill in the art to use a different material used as a weld as taught by Reichart to join the tubes of Peterson, as disclosed. The combination would have yielded the predictable results of the two tubings being joined to one another.
Regarding claims 8 and 10, Peterson teaches that the medical treatment system is an ophthalmosurgical system for treatment of an eye. See Peterson, para. [006] stating, “The ophthalmologic system can be a phacoemulsification, liquefaction, or other type of surgical system utilizing irrigation/aspiration handpieces.”
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0125699 to Davis et al. (“Davis”) in view of Reichert.
Regarding claim 1 and 9, Davis discloses a medical treatment system (see Fig. 1) comprising: a medical treatment instrument (9); a console (320) configured to supply fluid to said medical treatment instrument in a defined operating mode of the medical treatment system (see para. [0001] stating, “This invention relates generally to the field of phacoemulsification and more particularly to irrigation/aspiration ("I/A") systems used during phacoemulsification.”); a tube (325) for feeding an irrigation fluid from said console to said medical treatment instrument and for discharging an aspiration fluid from said medical treatment instrument to said console (see para. [0025] stating, “As best seen in FIG. 1, surgical console 320 suitable for use with the present invention may be any commercially available surgical control console such as the INFINITI.RTM. Vision System available from Alcon Laboratories, Inc., Fort Worth, Tex. Console 320 is connected to handpiece 9 through irrigation line 322 and aspiration line 324, and the flow through lines 322 and 324 is controlled by the user, for example, via a footswitch or a wireless remote control (not shown).”); said tube (325) including a first channel for feeding an irrigation fluid from said console to said medical treatment instrument; said tube further including a second channel for discharging the aspiration fluid from said medical treatment instrument to said console (see annotated Fig. 2 below);
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said first channel and said second channel being arranged in parallel next to each other in a direction of longitudinal extent of the tube (see annotated Fig. 2 above); said first channel having a first wall (322) including a first material having a first hardness (see paras. [0026-0027] cited below); said second channel (324) having a second wall including a second material having a second hardness (see paras. [0026-0027] cited below); said second hardness being greater than said first hardness (see para. [0026] stating, “aspiration line 324 can be made from a material having a relatively higher stiffness, or durometer, for example, on the order of between 75 shore A and 100 shore A durometer. As aspiration line 324 and irrigation line 322 are co-extruded, increasing the stiffness of aspiration line 324 results in a stiffer irrigation line.” and para. [0027] stating, “line 325 can be co-extruded so that irrigation line 322 is made from a softer (lower durometer) material than aspiration line 324. For example, irrigation line 322 may be made from a material having a stiffness on the order of 30 shore A to 70 shore A durometer”); said tube being formed from two individual tube elements (322 and 324, see also para. [0026] cited above disclosing “co-extruded” which necessarily includes two tube elements) including a first tube element (322) for said first channel and a second tube element (324) for said second channel; and, wherein a difference in hardness between said first hardness and said second hardness is at least 10 ShA and at most 15 ShA (see paras. [0026-0027] cited above). It is noted that tube 324 being made from material with a 80 ShA and tube 322 being made from material with a 70 ShA results in the second hardness at least 10 ShA difference from the first hardness.
Davis meets the claim limitations as described above but fails to disclose that “said first tube element and said second tube element being welded or adhesively bonded in a connection region.” However, Reichart discloses such a configuration.
Reichert shows multiple parallel tubing sets (400,416,418) being attached to one another using another material (460). See Fig. 5b and col. 20 ll. 29-47 stating, “The IV set system of FIG. 4b is shown as comprising a primary IV set 400 and two secondary IV sets 416 and 418 that are separably and physically joined together. In this particular example, the IV set system comprises a discontinuous type of attachment of the primary IV set 400 and the secondary lines 416 and 418 at fused locations 460 along the respective tubular flow line structures. In other words, discontinuous, isolated attachment members at fused locations 460 function to physically join the IV sets together. These attachment members at the various locations 460 are considered to be discontinuous as they are separated by unconnected segments of the tubular flow line structures. The isolated points of attachment or fused locations 460 cart comprise material integrally formed from the same material as the IV lines, or they can comprise a different material. In any event, the attachment members at fused locations 460 can comprise material that can facilitate the joining of one or more IV sets, and the selective separation or peeling away of these.” (emphasis added)
At the time of the invention, it would have been obvious to make the co-extruded tubing of Davis as joined welded tubing as taught by Reichert. Both references are analogous in the art of attached parallel medical tubing; therefore, a combination is proper. Additionally, the motivation is found in Reichert which states, “The isolated points of attachment or fused locations 460 cart comprise material integrally formed from the same material as the IV lines, or they can comprise a different material. In any event, the attachment members at fused locations 460 can comprise material that can facilitate the joining of one or more IV sets, and the selective separation or peeling away of these. In one aspect, the attachment members can be designed and configured to tear or rip. In another aspect, the attachment members can be designed and configured to separate or pull away from at least one of the IV sets.” See Reichert col. 20, ll. 44-51. One skilled in the art would have found it advantageous to provide irrigation and aspiration tubing that could be separated along the length of the tubing if needed.
Regarding claim 2, Davis shows wherein said first wall of said first channel has a first thickness; said second wall of said second channel has a second thickness; and, said first thickness is smaller than said second thickness. See Davis, Fig. 2 and para. [0026] indicating that the materials for the tubing can be different and also have different wall thicknesses.
Regarding claim 3, the claim recites, “wherein said first thickness is at least 1.25 millimeters” and regarding claims 4-5, the claims recite “wherein said second thickness is at least 1.3 millimeters.” The instant specification discloses that the wall thicknesses are chosen in order to resist kinking. Davis discloses that the wall thickness is chosen to reduce vacuum build-up, i.e. also prevent kinking and closing off the fluid path. Therefore, it would have been obvious by one skilled in the art to make the first wall thickness and second wall thickness of Davis 1.25mm and 1.3mm, respectively, since Davis would not operate differently and would function properly with the claimed wall thickness.
Regarding claim 6, the claim recites, “wherein said first channel has a first internal diameter of at least 3 millimeters; and, said second channel has a second internal diameter of at least 1.1 millimeters” and regarding claim 7, the claim recites, “wherein said first channel has a first external diameter of at least 5.5 millimeters; said second channel has a second external diameter of at least 4.1 millimeters; and, a difference between said first external diameter and said second external diameter is in a range of 0.9 millimeters to 1.6 millimeters.” The instant specification discloses that “It proves particularly advantageous if an internal diameter of the first channel is at least 3 mm, and an internal diameter of the second channel is at least 1.1 mm. Particularly for use in an ophthalmosurgical system, suitable flows of fluid can thus be achieved in the tube, such that a defined operating mode can be realized.” (para. [0021] in PG Pub). Davis is also a ophthalmosrugical system (see para. [0001] stating, “This invention relates generally to the field of phacoemulsification and more particularly to irrigation/aspiration ("I/A") systems used during phacoemulsification.”); therefore, it would have been obvious by one skilled in the art to make the tubing sizes of Davis the claimed sizes since Davis would not operate differently and would function properly with the claimed dimensions.
Regarding claims 8 and 10, Davis discloses wherein the medical treatment system is an ophthalmosurgical system for treatment of an eye (see para. [0001] stating, “This invention relates generally to the field of phacoemulsification and more particularly to irrigation/aspiration ("I/A") systems used during phacoemulsification.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993
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