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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/29/2024, 10/16/2024 and 10/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of group II, claims 12-16 and 62-71 in the reply filed on 06/01/2026 is acknowledged.
Response to Amendment
This office action is responsive to the amendment filed on 06/01/2026. As directed by the amendment: claims 1, 22 & 72 have been withdrawn. Claims 2-11, 17-21, 23-61 has been cancelled.
Thus, claims 12-16 and 62-71 are pending in this application with claims 1, 22, 72 being withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference number 11A in figure 18 is not in the description.
Reference number 14A in figures 23-30 is not in the description.
Reference number 16A in figures 25, 26 and 30 is not in the description.
Reference number 36A in figure 25 is not in the description.
Reference numbers 11B in figure 31 is not in the description.
Reference number 14B in figures 31 and 39 is not in the description.
Reference number 16B in figures 38 and 39 is not in the description.
Reference number 12B in figure 38 is not in the description.
Reference number 36B in figure 38 is not in the description.
Reference number 16C in figures 40 and 41 is not in the description.
Reference number 34D in figures 41 and 42 is not in the description.
Reference number 24D in figure 42 is not in the description.
Reference number 16D in figure 42 is not in the description.
Reference number 12D in figure 42 is not in the description.
Reference number 36D in figure 42 is not in the description.
Reference number 14E in figure 44 is not in the description.
Reference number 16E in figure 44 is not in the description.
Reference number 16F in figure 43 is not in the description.
Reference number 14F in figure 46 is not in the description.
Reference number 24F in figures 45 and 46 is not in the description.
Reference number 16F in figures 45 and 46 is not in the description.
Reference number 26F in figures 45 and 46 is not in the description.
Reference number 28F in figures 45 and 46 is not in the description.
Reference number 22F in figures 45 and 46 is not in the description.
Reference number 36F in figure 45 is not in the description.
Reference number 24G in figure 47A is not in the description.
Reference number 26G in figures 47 and 47A is not in the description.
Reference number 34G in figures 47 and 47A is not in the description.
Reference number 28G in figures 47 and 47A is not in the description.
Reference number 30G in figures 47 and 47A is not the description.
Reference number 22G in figures 47 and 47A is not in the description.
Reference number 36G in figures 47 and 47A is not in the description.
Reference number 11G in figure 48 is not in the description.
Reference number 12H in figures 49 and 49A is not in the description.
Reference number 14H in figures 49 and 49A is not in the description.
Reference number 34H in figures 48 and 49A is not in the description.
Reference number 34l in figure 52 and 56 is not in the description.
Reference number 16l in figure 52 is not in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 12-16, 64, 65, 67, 70 and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Dimalanta (US 20110112466 A1) in view of Akahoshi (US 20120197215 A1).
Regarding claim 12, Dimalanta discloses a phacoemulsification needle (110), comprising: a needle shaft portion (205) defining a longitudinal shaft axis (225), and having an internal aspiration passage (215); and an emulsification tip (tip of 110) joined to a distal end of said needle shaft portion (fig 1a), said emulsification tip having five side walls (fig 2a) defining a perimeter of an open mouth communicating with said aspiration passage (para 0008 and claim 1).
Dimalanta fails to teach two of said side walls converging in a rounded corner at a location in a vertical plane that extends through said longitudinal shaft axis but disclose two of said side walls maybe converging in a rounded corner (other four points 240a-d may be rounded to make them duller, see para 0021, fig 2b-d).
Akahoshi discloses a phacoemulsification needle (40) comprising a tip (190) having side walls wherein two of said side walls converging in a rounded corner at a location in a vertical plane that extends through said longitudinal shaft axis (fig 19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the side walls of Dimalanta to have two of said side walls converging in a rounded corner at a location in a vertical plane that extends through said longitudinal shaft axis as taught by Akahoshi. This would provide the benefit of having a less sharp corner to lessen the incidence of snags or cuts (abstract).
Regarding claim 13, Dimalanta in view of Akahoshi discloses the phacoemulsification needle in accordance with claim 12,
Dimalanta discloses wherein said five side walls have the same thickness (fig 2a).
Regarding claim 14, Dimalanta in view of Akahoshi discloses the phacoemulsification needle in accordance with claim 13 but fails to teach wherein said thickness is about 100 microns.
Dimalanta discloses five side walls have the same thickness (fig 2a).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the thickness of Dimalanta to have said thickness is about 100 microns since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the needle of Dimalanta would not operate differently with the claimed thickness and the device would function appropriately having the claimed thickness. Further, applicant places no criticality on the thickness claimed, indicating simply that the thickness “may” be about 100 microns (specification pp. [0101]).
Regarding claim 15, Dimalanta in view of Akahoshi discloses the phacoemulsification needle in accordance with claim 12,
Dimalanta discloses the phacoemulsification needle in combination with a vibratory handpiece (120, para 0017-19).
Regarding claim 16, Dimalanta in view of Akahoshi discloses the phacoemulsification needle in accordance with claim 12,
Dimalanta discloses wherein said open mouth defines a longitudinal mouth axis that is parallel to, and offset from, said longitudinal shaft axis (fig 2a, open mouth is wider than needle shaft, thus a longitudinal mouth axis is parallel to, and offset from, said longitudinal shaft axis).
Regarding claim 64, Dimalanta in view of Akahoshi discloses the phacoemulsification needle in accordance with claim 12,
Dimalanta fails to teach wherein said emulsification tip is sandblasted.
However, Akahoshi discloses wherein said emulsification tip is sandblasted (para 0110).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tip of Dimalanta and incorporate the teachings of Akahoshi to have said emulsification tip sandblasted. This would provide the benefit of enhancing safety and efficiency of phacoemulsification tip when the inner and outer surfaces of the phacoemulsification tip is roughened, as by sandblasting (para 0110).
Regarding claim 65, Dimalanta in view of Akahoshi discloses the phacoemulsification needle in accordance with claim 12,
Akahoshi discloses wherein adjacent ones of said five side walls converge at convex corners (fig 19).
Regarding claim 67, Dimalanta in view of Akahoshi discloses the phacoemulsification needle in accordance with claim 12,
Dimalanta discloses wherein said emulsification tip has a distal edge (fig 2c) defined by a converging pair of said walls disposed at a first acute angle to a plane extending normally through said longitudinal shaft axis, and a second pair of said walls are disposed at a second acute angle relative to said plane, said first acute angle being greater than said second acute angle (see annotated figure below, said first acute angle is less than said second acute angle).
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Regarding claim 70, Dimalanta in view of Akahoshi discloses the phacoemulsification needle in accordance with claim 12,
Dimalanta discloses wherein said emulsification tip has a distal edge disposed at an acute angle to a plane extending normally through said longitudinal axis of said needle shaft portion (see annotate figure above, said distal edge disposed at 20 degrees).
Regarding claim 71, Dimalanta in view of Akahoshi discloses the phacoemulsification needle in accordance with claim 12,
Dimalanta discloses wherein said acute angle is between about 20 and 40 degrees (see annotate figure above, said distal edge disposed at 20 degrees).
Claims 62 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Dimalanta (US 20110112466 A1) in view of Akahoshi (US 20120197215 A1) and further in view of Akahoshi et al (US 20150335482 A1).
Regarding claim 62, Dimalanta in view of Akahoshi discloses the limitations of claim 12 and further discloses wherein three of said side walls define a first thickness (see figures), the remaining two of said side walls converge at a location in a vertical plane that extends through said longitudinal shaft axis (fig 2e) but silent the remaining two of said side walls that have a second thickness that is greater than said first thickness.
Dimalanta discloses various modifications may be made to the presented embodiments by a person of ordinary skill in the art (para 0034).
Akahoshi et al teach a phacoemulsification needle comprising different sidewalls and a tip wherein the sidewalls of the emulsification tip can have varying thickness (abstract and 0022 and 0205).
Therefore, it would have been obvious to a person having ordinary skill in the art to have modified the said emulsification tip of Dimalanta to have sidewalls of varying thickness with the converging sidewalls having a greater thickness to have a non-uniform mass distribution to create a wobble effect for effective phacoemulsification (para 0022 and 0205).
Regarding claim 63, Dimalanta in view of Akahoshi and Akahoshi et al fail to expressly disclose wherein said first thickness is about 100 microns and wherein said second thickness is between about 150 and about 170 microns.
Dimalanta in view of Akahoshi and Akahoshi et al disclose wherein the sidewalls of the emulsification tip can have varying thickness (abstract and 0022 and 0205 of Akahoshi et al).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the thickness of Dimalanta to have said first thickness is about 100 microns and wherein said second thickness is between about 150 and about 170 microns since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the needle of Dimalanta would not operate differently with the claimed thickness and the device would function appropriately having the claimed thickness. Further, applicant places no criticality on the thickness claimed, indicating simply that the first thickness is about 100 microns and the second thickness is preferably between about 150 microns and about 170 microns. (specification pp. [0015]).
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Dimalanta (US 20110112466 A1) in view of Akahoshi (US 20120197215 A1) and further in view of Scott (US 20170216536 A1).
Regarding claim 66, Dimalanta in view of Akahoshi disclose the limitations of claim 12 but fails to teach wherein said aspiration passage has a pentagonal cross-sectional shape in a plane normal to said longitudinal shaft axis.
However, Scott discloses a needle (500) to penetrate biologic tissue, including the eye configured for injection into or withdrawal of liquids or gas from the eye (para 0002) wherein said aspiration passage (504) has a pentagonal cross-sectional shape in a plane normal to a longitudinal shaft axis (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the aspiration passage of Dimalanta to have a pentagonal cross-sectional shape as taught by Scott as alternative design to aspirate material through said needle by having a non-uniform lumen (para 0009).
Claims 68 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Dimalanta (US 20110112466 A1) in view of Akahoshi (US 20120197215 A1) and further in view of Zawacki et al (US 20040167463 A1).
Regarding claim 68, Dimalanta in view of Akahoshi disclose the limitations of claim 12 but fails to teach wherein said emulsification tip has an intermediate passage formed therein that is offset from said longitudinal shaft axis.
However, Zawacki et al disclose a shaft (100) comprising a tip (124) wherein said tip has an intermediate passage (163) formed therein that is offset from said longitudinal shaft axis (fig 11D).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tip of Dimalanta to have a an intermediate passage formed therein that is offset from said longitudinal shaft axis. This would provide a benefit of having a passage that could be used to provide passage of fluid source such as irrigation fluid during phacoemulsification (para 0018).
Regarding claim 69, Dimalanta in view of Akahoshi and Zawacki et al disclose the phacoemulsification needle in accordance with claim 68,
Zawacki et al disclose wherein said intermediate passage is semi-circular and is centered along a vertical plane extending through said longitudinal shaft axis (figs 10 and 11D).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 08/20/2026
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