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
Claims 2 and 6 are objected to because of the following informalities:
In line 1 of claim 2, “ones of” should be changed to “each one of”.
In line 1 of claim 6, “ones of” should be changed to “each one of”.
Appropriate correction is required.
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.
Claim(s) 1-3, 5, 7-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Banko (US 2014/0276369).
Regarding claim 1, Banko discloses a phacoemulsification handpiece (Tip 320, FIG 17, which is usable with an ultrasonically driven phacoemulsification tool, [0068]) comprising: a first segment (346, [0068-0074]) having a longitudinal axis (Up and down axis as viewed in FIG 17, see dashed line), and a first end (Top end as oriented in FIG 17) and a second end (Bottom end as oriented in FIG 1), wherein at least aspiration (from 360 within 334, [0071]), irrigation (from 360 within 332, [0067]), and power input enters the first end (102 powers the ultrasonic work tip at the distal end. FIG 5A shows the power source is located at the proximal end and must be conveyed to the distal end, therefore it enters through the first end of the first segment); a second segment (326) along the longitudinal axis (FIG 17, the first and second segment are coaxial along the same dashed line) and comprising, at a distalmost portion thereof from the first segment, an aspiration output (The distal opening 326a which 334 extends out of), and an irrigation output (The distal opening of 326a which 332 extends out of); a rotating coupler (335) capable of coupling the second end of the first segment and the second segment to enable independent axial rotation about the longitudinal axis of the first segment from the second segment ([0068], 3335 is a threaded collar therefore it is rotatable. When it is slightly loosened, independent axial rotation of 326 relative to 346 is permitted); and a plurality of flexible tubing (360, [0074]; “semi-rigid’ is interpreted has having at least some properties of being flexible) passing substantially along the longitudinal axis within both the first segment and the second segment (See passiage through 346 and 326, FIG 17), wherein at least a first flexible tube of the plurality provides continuous fluidic communication between the aspiration input and the aspiration output (Tube 360 on the right as viewed in FIG 17 which provides aspiration to 334), and at least a second flexible tube of the plurality provides continuous fluidic communication between the irrigation input and the irrigation output (Tube 360 on the left as viewed in FIG 17 which provides a fluid pathway to irrigation port 332); wherein the plurality of flexible tubing flexes within the first and second segments and within the rotating coupler so as not to bind during the independent axial rotation ([0071] discloses 346 is rotated and “the rotation from the first to the second position is in one direction and the rotation from the second to the first is in the opposite direction so that the infusion and aspiration tubes receive a half twist, but do not become completely twisted”. The tubes receiving a half twist discloses that the tubes flex upon axial rotation but do not bind).
Banko teaches the ultrasonic power output vibrates the work tip but fails to disclose vibration of a needle. Banko also teaches that tip 320 can be sued with an ultrasonically driven phacoemulsification tool ([0068]).
Banko teaches a prior art ultrasonically driven phacoemulsification tool (FIG 6) having a working tip comprising a needle (14, [0005]) powered by the ultrasonic vibrational output ([0005]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the present embodiment to further comprise the ultrasonically powered needle taught by the prior art, in addition to the aspiration and irrigation ports of the working tip, for the purpose of enabling the user to perform phacoemulsification and aspiration of the particles using the same device and therefore reducing need to change instruments, thus improving procedure time and reducing the risk of infection and trauma [0015]).
Regarding claim 2, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses ones of the plurality of flexible tubing comprise multiple distinct pieces of tubing (FIG 17 hows each of the tubing are distinct pieces of tubing).
Regarding claim 3, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further a tube cavity within the first segment (347 and 349), the second segment (342, and 344), and the coupler (The annular opening of 335 through which 315 passes), wherein the passing of the plurality of flexible tubing substantially along the longitudinal axis within both the first segment and the second segment comprises passing through the tube cavity (FIG 17; see tubes 360 passing through cavities in each of the pieces).
Regarding claim 5, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses the axial rotation is unconstrained by the plurality of flexible tubing over at least 90 degrees of relative independent axial rotation ([0071] the tubes receive a half twist, which is 180 degrees).
Regarding claim 7, Banko disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified by Banko further discloses a flexible power cable (40, 41, 12, FIG 6, [0007] substantially commensurate with the plurality of flexible tubing from the power input to a power supply for the needle (Terminals 40, 41 and coils 12 are interpreted as a flexible power cable which provides power to the needle, [0004-0007]).
Regarding claim 8, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses a tubing manager (315) that at least partially positionally maintains the plurality of flexible tubing (FIG 17).
Regarding claim 9, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses a plurality of internal couplings for at least the plurality of flexible tubing having an angular orientation to de-stress the plurality of flexible tubing at the internal coupling upon the axial rotation (the outwardly angled surfaces of 347 and 349 are interpreted as internal coupling which destress the flexible tubing by providing a gradient transition and eliminating any protrusions which may stress the tubing during rotation).
Regarding claims 11-14, Banko disclose the invention substantially as claimed, as set forth above for claim 1.
Banko is silent regarding a first seal comprising an o-ring gasket between the first segment and the rotating coupler and a second seal comprising an o-ring gasket between the second segment and the rotating coupler.
However, Banko teaches in the alternative embodiment of FIG 5A, a rotating coupler (190) equivalent to the rotating coupler 335 of the present embodiment and a connecting body (204) equivalent to the first and second segments of the present embodiment, and further comprising an o-ring gasket (193, FIG 5A-5B, [0053 and 0057]) creating a seal between the rotating coupler 190 and the body segment 204.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the present embodiment to have a first and second o-ring gasket seal between the first and second segments and the rotating coupler, as taught by the embodiment of FIG 5, for the purpose of preventing leakage of the infusion and aspiration fluids at the rotatable interface.
Regarding claim 15, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses the first segment is separable from the rotating coupler (335 is a threaded collar which can be untreaded and therefore removed).
Regarding claim 16, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses the second segment is separable from the rotating coupler (335 is a threaded collar which can be untreaded and therefore removed).
Regarding claim 17, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses the separability of the second segment enables a change to at least the needle (The working tip can be changed by providing a different tip for use with the same sleeve 346 and coupler 335).
Regarding claim 18, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses the first segment is sterilizable (Since 326 can be separated from the remainder of the device, it could be wiped off using a sterilized wipe).
Regarding claim 19, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses the second segment is disposable (The second segment is disposable because the elements could be detached or the either device could be disposed of. Examiner notes the claim does not require a step of disposing only the second segment or similar).
Regarding claim 20, Banko disclose the invention substantially as claimed, as set forth above for claim 1. Banko further discloses the plurality of flexible tubing is capable of both flexation and rotation (Due to the ability of the tube to twist and untwist, it is capable of rotation and flexing or bending at least to some degree).
Claim(s) 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Banko (US 2014/0276369) in view of Akahoshi (US 2006/0079832).
Regarding claims 4 and 6, Banko disclose the invention substantially as claimed, as set forth above for claim 1.
Banko is silent regarding the plurality of flexible tubing being substantially elastic and comprising silicon.
However, Akahoshi teaches in the same field of endeavor a phacoemulsification handpiece (FIG 6, abstract, [0030-0036]) having aspiration and irrigation provided by a plurality of flexible tubing (Tubes 40 and 42, FIG 6, [0033 and 0036]), wherein the flexible tubing is substantially elastic and comprises silicon ([0031]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the plurality of flexible tubing of Banko to be made of a material comprising silicone, as taught by Akahosi, for the purpose of selecting a biocompatible material commonly known in the art for having elastically flexible properties such that the tubes and twist and untwist as required by the operational movement disclosed by Banko.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Banko (US 2014/0276369) in view of Raney (US 2010/0069825).
Regarding claim 10, Banko disclose the invention substantially as claimed, as set forth above for claim 1.
Banko is silent regarding the needle being actuated by piezoelectric crystals located in the second segment and powered from the power input.
However, Raney discloses a phacoemulsification handpiece (200, FIG 3, paragraph [0041]) having a needle (210) actuated by piezoelectric crystals (280, paragraph [0044]) located in a second segment (FIG 3, this region is equivalent to the second segment) and powered from the power input (“electric power” disclosed in paragraphs [0044-0045]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the second segment of Banko to comprise piezoelectric crystals capable of receiving power to actuate the needle, as taught by Raney, for the purpose of providing a feature commonly known in the art for achieving the predictable result of vibrating the horn and therefore needle of the ultrasonic handpiece (Paragraph [0044]).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,171,930. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are more narrow and therefore anticipate the broader claims of the application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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