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 .
Response to Amendment
The amendment filed 11/20/2025 has been entered. Claims 1-7 are pending in the application. Applicant’s amendments to the claims have/have not overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 09/04/2025.
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.
Claims 1, 2, 4 are rejected under 35 U.S.C. 103 as being unpatentable over Urich (US 2020/0222236) in view of Nilsson (US 5,873,851) and further in view of Parins (US 2009/0036833) as evidenced by Kranys (US 5,405,338) and Berg (US 2004/0243102).
Regarding Claim 1, Urich discloses a phacoemulsification probe (100, Fig 1) comprising: an irrigation sleeve (104, Fig 1) configured to fit over a hollow aspiration needle (106, Fig 1) and a probe body (126, Fig 1), said irrigation sleeve to provide a fluid pathway for the flow of irrigation fluid between said needle and walls of said irrigation sleeve (Para 0026; See arrows in Fig 1 showing fluid pathway formed by the sleeve 104 and out of the ports 102), said sleeve having a distal end insertable into an incision made in an eye (See Fig 1), said distal end having ports (102, Fig 1) to release said irrigation fluid into said eye.
Urich is silent regarding the walls of said irrigation sleeve have at least one anti-tortional element longitudinally placed along a length of said sleeve to provide structural support to prevent twisting of said sleeve; and wherein said at least one anti-tortional element allows flattening of said irrigation sleeve for maneuvering of said sleeve within said eye while preserving the integrity of said incision.
Nilsson teaches an analogous phacoemulsification probe (device of Fig 12) comprising an irrigation sleeve (240, Fig 12) configured to fit over a hollow aspiration cannula (202, Fig 12), wherein the walls of said irrigation sleeve have at least one anti-tortional element (242, Fig 12) longitudinally placed along a length of said sleeve to provide structural support to prevent twisting of said sleeve; and wherein said at least one anti-tortional element allows flattening of said irrigation sleeve for maneuvering of said sleeve within said eye while preserving the integrity of said incision (Col 4, lines 22-29; As evidenced by Kranys and Berg, helically wound coils provide torsional rigidity to prevent twisting and kinking as detailed in Col 1, lines 6-12 of Kranys and Para 0006 of Berg).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the irrigation sleeve disclosed by Urich to include a helical spring as taught by Nilsson in order to have a sleeve that can partially compressed in order to make a good seal when inserted through the incision in the cornea while being completely pinched closed at the incision (Col 4, lines 22-29).
The modified invention of Urich and Nilsson discloses all of the elements of the invention as discussed above, however, is silent regarding the at least one anti-tortional element comprising a flat strip.
Parins teaches a probe comprising a reinforcing or anti-tortional element (190, Fig 8), wherein the anti-tortional element comprises a flat strip (Para 0073).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reinforcing wire/anti-tortional element disclosed by Nilsson to be a flat strip as Parins teaches that a round wire or a flat wire could be used to achieve the same result (reinforcing a tube as described in Para 0073) and thus a round wire and a flat wire were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
Regarding Claim 2, the modified invention of Urich, Nilsson, and Parins discloses said at least one anti-tortional element (242, Fig 12 -Nilsson) is embedded in said walls (See Fig 12 -Nilsson).
Regarding Claim 4, the modified invention of Urich, Nilsson, and Parins discloses said at least one anti-tortional element (242, Fig 12 -Nilsson) forms a spiral around said irrigation sleeve (See Fig 12 -Nilsson).
Claims 3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Urich (US 2020/0222236) in view of Nilsson (US 5,873,851) and further in view of Parins (US 2009/0036833) and further in view of Mackool (US 5,685,841).
Regarding Claim 3, the modified invention of Urich, Nilsson, and Parins discloses all of the elements of the invention as discussed above, however, is silent regarding said at least one anti-tortional element is affixed to the outside of said walls.
Mackool teaches a tube (36, Fig 13) having a structural support element (58, Fig 13) wherein the structural support element may be embedded within the wall of the tube or affixed to the outside of said walls (Col 2, lines 50-61; See Fig 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anti-tortional element disclosed by Nilsson to be affixed to the outside of wall of the irrigation sleeve as Mackool teaches that the anti-tortional element embedded in the wall or the anti-tortional element affixed to the outside of the wall could be used to achieve the same result (providing reinforcement of the tubing as detailed in Col 2, lines 42-61) and thus were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
Regarding Claim 5, the modified invention of Urich, Nilsson, Parins, and Mackool discloses said at least one anti-tortional element forms a spiral around said irrigation sleeve (See Fig 13 -Mackool).
Regarding Claim 6, the modified invention of Urich, Nilsson, and Parins discloses all of the elements of the invention as discussed above, however, is silent regarding said irrigation sleeve is manufactured from silicon.
Mackool teaches that it is desirable to make a tube out of a soft, elastic, expandable material such as silicone to counteract the momentary flow surge (Col 4, lines 38-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the irrigation sleeve to be made of silicone as taught by Mackool in order to have a tube that can counteract momentary flow surges(Col 4, lines 38-52).
Regarding Claim 7, the modified invention of Urich, Nilsson, and Parins discloses all of the elements of the invention as discussed above, however, is silent regarding said at least one anti-tortional element is manufactured from metal.
Mackool teaches that it is desirable to manufacture a reinforcement element from metal to provide a noncompressible, rigid, material that is able to provide the support needed to the tubing (Col 5, lines 11-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anti-tortional element to be made of metal as taught by Mackool in order to have a support element that is non-compressible and rigid (Col 5, lines 11-19).
Response to Arguments
Applicant’s arguments filed 11/20/2025, on pages 4-5, regarding Urich, Nilsson, Kranys, and Berg failing to teach the at least one anti-tortional element comprising a flat strip have been fully considered but are moot in view of the current rejection that relies on Parins to teach the flat strip.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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