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 .
This office action is in response to applicant’s communication of 4/27/2026. Currently claims 1-17 are pending and rejected below.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-10, and 17 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by McKay et al. (US 7,850,656 B2).
McKay discloses a needle (as in figures 3c-14) for use with a phacoemulsification handpiece comprising: an elongated needle body (24 for example) having a proximal end (near 32) and a distal end terminating at a junction point (near 28); a first tine (left most 23) having a proximal end and a distal end terminating in a first tip (end of 23); a second tine (right most 23) having a proximal end and a distal end terminating in a second tip (end of 23); wherein the proximal end of the first tine and the proximal end of the second tine are each connected at the junction point (near 28).
Concerning the claim language of the needle body “configured to be coupled to the phacoemulsification handpiece to receive ultrasonic power”, examiner is of the positon that the phacoemulsification handpiece is not positively claimed. Further examiner is of the position that the McKay needle body is “configured to” be coupled as there is an attachment portion on the proximal side that would allow the needle and needle body to be coupled to a variety of medical devices for example a phacoemulsification handpiece as McKay contains structural elements that would allow this.
Concerning claim 2 and the first tine and the second tine each have an outward curve to form a U-shape (see embodiments shown in figures 6, and 9-12a for examples).
Concerning claim 3 and a distance between the first tip and the second tip is larger than the distance between the proximal end of the first tine and the proximal end of the second tine near the junction point to form a V-shape (see figures 6, 9-12a for examples).
Concerning claim 4 and the first tip is one of straight or beveled (note tips of tines of the MaKay is beveled or straight in the embodiments of the figures).
Concerning claim 5 and the second tip is one of straight or beveled (note tips of tines of the MaKay is beveled or straight in the embodiments of the figures).
Concerning claim 6 and the needle body, the first tine, and the second tine include an aspiration lumen therethrough (note channels 37a and 37b).
Concerning claim 8 and one or more additional tines (see figure 6 for example).
Concerning claim 9 and the one or more additional tines are in the same plane as the first tine and the second tine (again see figure 6 for example).
Concerning claim 10 and the one or more additional tines are not in the same plane as the first tine and the second tine (see figures 9 and 11 for examples).
Concerning claim 17 and the first tine and the second tine are arranged symmetrically about a central longitudinal axis of the elongated needle body such that, when ultrasonic power is applied, the first tine and the second tine move with equal amplitudes, see figures 3c and 4a which shows tines that are symmetrically arranged about a longitudinal axis. Further it appears that each tine is of the same length, shape, material, and structure so that they would move in equal amplitudes when ultrasonic power was applied.
Claim(s) 11, and 16 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Choi (US 2010/0286618 A1).
Choi discloses a device for installing a needle in a phacoemulsification handpiece comprising, the device (as in figures 5-9 and element 350/220) comprising: a first vertical portion and a second vertical portion (near 310 portions surrounding the needles), wherein the first vertical portion includes a first hollow portion (interior in which needles reside) and the second vertical portion includes a second hollow portion (other interior space in which other needles reside); and a first horizontal portion (near 230 portion as in figure 6 for example) connecting the first vertical portion and the second vertical portion; wherein the first hollow portion and second hollow portion each have a circumference substantially similar to a first tine and a second tine of the phacoemulsification needle and are configured to receive the first tine and the second tine (as in figures 5-9 shown with needles 310 of the device).
Concerning the claim language of the needle body “the device is configured to apply torque to the needle, via the first tine and second tine, to move the needle into and out of the phacoemulsification handpiece”, examiner is of the position that the needle is not positively claimed. Further examiner is of the position that the Choi device is “configured to” apply torque to a needle or any force depending on the application of the device element 350/220 structure in relation to the needle and rest of the device. It is examiners position that Choi contains structural elements that would allow this torque if the device was twisted for instance.
Concerning claim 16 see Choi disclosure of a phacoemulsification needle system comprising:phacoemulsification needle (as in figures 5-9 for examples), comprising: an elongated needle body (200) having a proximal end and a distal end terminating at a junction point (near 215); a first tine one of 310) having a proximal end and a distal end terminating in a first tip; a second tine (another 310) having a proximal end and a distal end terminating in a second tip; wherein the proximal end of the first tine and the proximal end of the second tine are each connected at the junction point (near 215). a phacoemulsification needle tool (350), comprising: a first vertical portion and a second vertical portion (structural portions near 310/351), wherein the first vertical portion includes a first hollow portion (interior space in which needles reside) and the second vertical portion includes a second hollow portion (other interior space in which other needles reside); and a first horizontal portion (near 230) connecting the first vertical portion and the second vertical portion; wherein the first hollow portion and second hollow portion each have a circumference substantially similar to the first tine and the second tine and are configured to receive the first tine and the second tine (as in figures 5-9 shown with needles 310 of the device).
Concerning the claim language of the needle body “the device is configured to apply torque to the needle, via the first tine and second tine, to move the needle into and out of the phacoemulsification handpiece”, examiner is of the position that the tool would be configured to apply torque if twisted. Further examiner is of the position that the Choi tool is “configured to” apply torque to a needle or any force depending on the application of the device element 350/220 structure in relation to the needle and rest of the device (if a user was to twist the device in a rotational way). It is examiners position that Choi contains structural elements that would allow this torque if the device was twisted for instance.
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKay et al. (US 7,850,656 B2).
Concerning claim 7, McKay discloses the claimed invention except for the needle body includes internal threads. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the needle body with internal threads since it was known in the art that attaching needles to another devices may be done with external threads or internal threads as they are well known equivalents. The prior art of McKay discusses the use of “luer-lock connectors” (such as 17/51). These are well known external threads for connection. It is examiner position that a PHOSITA would know to use internal threads for a connection means not only as a well known substituded equivalent for connection but also in the alternative as a well known design choice as it would appear equally as well with extrenal or internal threads for connection.
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US 2010/0286618 A1).
Concerning claim 12, Choi discloses the claimed invention except for does not expressly disclose what the vertical portions are made of titanium or stainless steel. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the first vertical portion and the second vertical portion made of titanium or stainless steel., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Titanium and stainless steel are well known materials to a PHOSITA in the medical arts to craft needle and medical devices from since they are well known to be safe, durable, hygienic, easy to sterilize and corrosion resistance. A PHOSITA would chose these materials to construct the medical device from in order for it to have the preferred properties above.
Concerning claim 13-15, Choi discloses the claimed invention except for does not expressly disclose what the vertical portion are made from silicon or rubber. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the first vertical portion and the second vertical portion made of silicon or rubber., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Silicon and rubber are well known materials to a PHOSITA in the medical arts to craft needle and medical devices from since they are well known to be safe, biocompatibile, preventing allergic reactions and tissue rejection, alongside superior flexibility, durability, and chemical inertness, Its properties allow for easy sterilization, resistance to bacteria, thermal stability, and electrical insulation, supporting diverse applications from wound care and drug delivery enhancing patient safety and device reliability. A PHOSITA would chose these materials to construct the medical device from in order for it to have the preferred properties above. It is examiners position that if constructed of these materials than the first hollow portion and second hollow portion would be highly frictional surface.
Response to Arguments
Applicant’s arguments, filed 4/27/2026, with respect to the 112 rejection have been fully considered and are persuasive. The 112 rejection of 13-15 has been withdrawn.
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive. Applicant’s argue that the amended claim language is not taught in the prior art of record. Examiner disagrees.
It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitation of the claim. Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon.
As stated in the rejection above concerning the claim language of the needle body “configured to be coupled to the phacoemulsification handpiece to receive ultrasonic power”, examiner is of the positon that the phacoemulsification handpiece is not positively claimed. Further examiner is of the position that the McKay needle body is “configured to” be coupled as there is an attachment portion on the proximal side that would allow the needle and needle body to be coupled to a variety of medical devices for example a phacoemulsification handpiece as McKay contains structural elements that would allow this. Again concerning the claim language of the needle body “the device is configured to apply torque to the needle, via the first tine and second tine, to move the needle into and out of the phacoemulsification handpiece”, examiner is of the position that the needle is not positively claimed. Further examiner is of the position that the Choi device is “configured to” apply torque to a needle or any force depending on the application of the device element 350/220 structure in relation to the needle and rest of the device. It is examiners position that Choi contains structural elements that would allow this torque if the device was twisted for instance.
The elements disclosed in the prior art of record are fully capable of satisfying all structural, functional, spatial, and operational limitations in the amended claims, as currently written, and the rejection is made.
Examiner recommends applicant amend the claim language to positively claim structures to overcome the prior art of record of McKay and Choi.
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 PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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