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 5/26/2023. Currently claims 1-16 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 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 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).
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 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).
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “hollow portion” in claims 11 is used by the claim to mean “a space or void”. Later in claims 13-15 the claims specify that the hollow portion is a highly frictional surface and includes silicon or rubber. It is contradictory that a hollow portion can contain a material. Examiner recommends that applicant amend the claims to correct this by adding it has a positively claimed structural surface or element or link the limitations to the “vertical portions”.
Appropriate correction is required.
Conclusion
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