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 Arguments
Applicant’s arguments, see page 5-8, filed 07/21/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 102(a)(1) have been fully considered but are not persuasive. Applicant argues on pages 5-6 that Akahoshi fails to teach a sheath portion as claimed because the body portion 44 is a cannula of a needle. However, it is the examiner’s position that under broadest reasonable interpretation, element 44 forms an elongate tubular structure which can reasonably be interpreted as a sheath portion. Element 44 further includes a mount 42 for attaching to another structure, therefore meeting the functional limitation of “for being affixed around the cannula”, wherein examiner notes a cannula is not positively recited in the claim. Therefore, applicants’ argument is not persuasive as it is believed that the tubular elongate structure of 44 sufficiently teaches a sheath portion of the tip as claimed. Applicant further argues on pages 6-7 that elements 74/76 cannot be interpreted as a recess because they instead are ‘holes or ports’. It is the examiners position that the term “recess” does not exclude the presence of a through hole as suggested by applicants’ arguments. It is the examiner’s position that applicant’s interpretation of a recess is overly narrow and that descriptions of the feature from the specification should not be read into the claims. Elements 74/76 are believed to reasonably meet the requirements of a recess because they form a small hollowed-out space set back into a surface.
Regarding claim 10, applicant argues that modifying the material of the tip form a metal to an elastomer would destroy the intended function of the device. Applicant points to the abstract and [0017, 0056-0058]) of Akahoshi but none of these passages disclose a metal material being used to form the tip or any part of the device. Therefore, applicant’s arguments are not found to be persuasive because it is relying on assertion of the original materials of Akahoshi being modified when Akahoshi is actually silent regarding the use of any specific materials.
Regarding claim 6 and 12, applicant argues that the modification to change the shape of the recesses and tip of the device is improper. However, examiner maintains that the specification of the present invention fails to teach a criticality of the claimed shapes. Examiner a circular versus oval/elongate recess would not affect the function of the device. Further, regarding the spherical shape of the tip, the specification discloses that spherical, ovoid, or rounded rectangular shapes each function appropriately. Therefore, applicants arguments are not found to be persuasive.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 8, 11, 13, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Akahoshi (US 2008/0058708).
Regarding claim 1, Akahoshi discloses a hollow tip (66, FIG 7-8, [0061-0062]; described more generally with respect to FIG 3-4) for use with a cannula (proximal end 42, FIG 3, is able to connect to a catheter), said tip comprising: a sheath portion (44) for being affixed around the cannula (The cannula is not positively recited. However, the proximal end of 44 can be affixed around a cannula via the mount 42 at its proximal end), said sheath portion defining a central axis (Centerline as shown in FIG 7); and a terminal portion (68/70) extending from said sheath portion along said central axis (FIG 7, 68 is integral with the sheath and positioned at least partly along the axis as shown), said terminal portion and said sheath portion defining an internal passage (72, FIG 8; [0052] discloses a hollow passageway is formed extending from mount 42 through tip 46 and is used to aspirate emulsified lens fragments during surgery. The tip of FIG 7 is understood to have the same hollow passageway for aspiration) communicating with at least one port (Opening of oval mouth 72) in said terminal portion to permit fluid communication through said tip ([0052, 0061-0062]), said terminal portion including at least one recess therein (74 and 76) for indicating the location of said at least one port (The lateral recesses can be used to identify the location of the central port because they are positioned at a fixed longitudinal and rotational location relative to the port) and/or inhibiting adherence of eye tissue to said tip, wherein said at least one recess has the form of a plurality of recesses (FIG 8 shows there are a plurality of recesses), and wherein said plurality of recesses extend only along an arc extending through a center of said at least one port (Line C in FIG 8 is shown in cross section but along follows the path of an arc which can be taken through the center of the port and the center of each recess), wherein said plurality of recesses extend on opposite sides of said at least one port along said arc (FIG 8 shows the recesses are positioned on opposite sides to the port).
Regarding claim 2, Akahoshi discloses the tip in accordance with claim 1 in combination with a cannula and a handpiece connected to a vacuum source ([0019 and 0052] disclose not shown is a phacoemulsification handpiece, which is understood to include a vacuum source in order to produce the aspiration) and/or an infusion fluid supply source.
Regarding claim 5, Akahoshi discloses said plurality of recesses are circular (FIG 7-8 shows 74,76 are s circular).
Regarding claim 8, Akahoshi discloses said sheath portion defines a first diameter and said terminal portion defines a second diameter that is greater than said first diameter (FIGs 7-8 show the terminal portion having a larger diameter than sheath portion 44).
Regarding claim 11, Akahoshi discloses said terminal portion defines an outer surface that is relatively rougher than said sheath portion ([0062] outer surface 68 of the terminal portion is roughened by sandblasting).
Regarding claim 13, Akahoshi discloses said terminal portion is ovoid (FIG 8 shows the ovoid shape at least in the cross section).
Regarding claim 14, Akahoshi discloses said terminal portion is semi-ovoid (FIG 7 shows a truncated shape which is interpreted as being semi-ovoid along its length).
Regarding claim 16, Akahoshi discloses said terminal portion is truncated at a distal end thereof (FIG 7 shows the distal tip is truncated at lip 70).
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) 6, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Akahoshi (US 2008/0058708).
Regarding claim 6, Akahoshi discloses the invention substantially as claimed, as set forth above for claim 1.
Akahoshi is silent regarding said plurality of recesses are elongate.
However, it would have been an obvious matter of design choice to modify the plurality of recesses to be elongate instead of circular, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). The modification would also be obvious since applicant has not disclosed that having the recesses being elongate provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either design. Paragraph [0013-0014] of the specification of the present invention discloses the recesses can be circular, semi-circular, elongate, or linear in shape and does not provide criticality of one shape over the other.
Regarding claims 12 and 15, Akahoshi discloses the invention substantially as claimed, as set forth above for claim 1. Akahoshi further discloses alternative embodiments wherein the terminal portion takes a spherical shape (FIG 9-10 and FIG 18), a triangular shape (FIG 13-14), and a rounded rectangular parallelepiped (FIG 20-21).
Therefore, it would have been an obvious matter of design choice to modify the terminal portion of the present embodiment to be spherical or a rounded rectangular parallelepiped, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). The modification would also be obvious since applicant has not disclosed that having the terminal portion being spherical or a rounded rectangular parallelepiped provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either design. Paragraph [0019-0021] of the specification of the present invention discloses the terminal portion can be spherical, ovoid, or semi-ovoid in shape and does not provide criticality of one shape over the other.
Claim(s) 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Akahoshi (US 2008/0058708) in view of Nallakrishnan et al. (US 2016/0374854).
Regarding claim 9, Akahoshi discloses the invention substantially as claimed, as set forth above for claim 1. Akahoshi further discloses said at least one port is angled relative to said central axis (FIG 7).
Akahoshi is silent regarding the port being angled between about 40 degrees and about 50 degrees relative to said central axis.
However, Nallakrishnan teaches a tip (20, FIG 2) for use with a cannula (12) having a sheath portion (28, FIG 4, [0040]) forming a central axis (axis formed by 18), and a terminal portion (24) having a port (29) which is angled between 40 and 50 degrees relative to the central axis ([0044] discloses an angle of 45 degrees).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the port of Akahoshi to be angle at 45 degrees relative to the central axis, as taught by Nallakrishnan, for the purpose of selecting an angle commonly known in the art to offset the port with a desirable degree of maneuverability in order to allow the tip 20 to be used to aspirate particles from the eye without removing and reorienting the apparatus ([0044]).
Regarding claim 10, Akahoshi discloses the invention substantially as claimed, as set forth above for claim 1.
Akahoshi is silent regarding the materials used to form the tip, specifically the tip being formed from an elastomer.
However, Nallakrishnan teaches a tip (20, FIG 2) for use with a cannula (12) having a sheath portion (28, FIG 4, [0040]) forming a central axis (axis formed by 18), and a terminal portion (24) having a port (29), wherein the tip is formed of an elastomer ([0042-0043]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the material of Akahoshi to be an elastomer, as taught by Nallakrishnan, for the purpose of selecting a material commonly known in the art for having the desired degrees of softness or tackiness having sufficient strength to retain the shape of the tip during surgical procedure ([0042-0043]).
Conclusion
THIS ACTION IS MADE FINAL. 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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
