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 .
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.
Claim(s) 11 is/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.
Regarding Claim 11, Applicant recites “a housing having a distal end” and “a cannula attached to the distal end of the surgical device”. However, this limitation creates confusion as the “surgical device” (only recited in the preamble as comprising the assembly as a whole) is never recited as having a particular “a distal end” and it is unclear if this “the distal end” is the same or different from that of the housing, expressly introduced.
Claim Rejections - 35 USC § 102
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) 1-4, 6-8, 10-14, 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2014/0074013 (“McCary”).
Regarding Claims 1 and 11, McCary discloses an ophthalmic surgical device (Fig. 1) comprising:
A housing (10) having a distal end to form a surgical handpiece;
Ultrasonic needle attached to the ophthalmic surgical handpiece, the ultrasonic needle (see generally Fig. 7) comprising:
A cannula (18) having a proximal end (see at 25, 27) and a distal end (see at 20, 22), the proximal end configured for attachment to an ophthalmic surgical handpiece (10), the distal end including a tip (80 or 110) with at least one aspiration port (82 or 112) in communication with a lumen extending through the cannula;
A vibration source (26) disposed within the housing for vibrating the distal tip of the cannula; and
A flexible member (84 or 116 – Par. 76) coupled to the distal end of the cannula for tissue manipulation (Par. 76, 77, 80).
Regarding Claims 2 and 12, in some embodiments (see Fig. 8) McCary discloses the flexible member is a loop of flexible material.
Regarding Claims 3 and 13, McCary discloses the loop comprises a strand having a first end and a second end, wherein the first end and the second end are coupled to the distal end of the cannula (see where the two sides of the loop adjoin the circular loop upon which the cannula tip is mounted).
Regarding Claims 4 and 14, McCary discloses the loop is parallel to a central longitudinal axis of the cannula (see Fig. 8A).
Regarding Claims 6 and 16, McCary discloses in some embodiments the flexible member is a button (116) of flexible material.
Regarding Claims 7 and 17, McCary discloses the button includes a distal surface (see the dome shaped distal face), a tapered surface (see the proximal, narrowed end), and a lip (see the ribbed/lipped intermediary geometry) between the distal surface and the tapered surface (see Fig. 11).
Regarding Claims 8 and 18, McCary discloses the distal surface is perpendicular to a central longitudinal axis of the cannula (see Fig. 11 – i.e. the major face of the distal surface when viewed in profile lies perpendicular to the central longitudinal axis in the same manner as Applicant’s illustrated configuration – see e.g. Fig. 4).
Regarding Claims 10 and 19, McCary discloses the flexible member is silicone (Par. 76).
Regarding Claim 20, McCary discloses the housing and vibration source are part of a phacoemulsification surgical handpiece (Abstract).
Claim Rejections - 35 USC § 103
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.
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0074013 (“McCary”) as applied above, and further in view of U.S. Publication No. 2007/0219466 (“Tremulis”).
Regarding Claims 5 and 15, McCary discloses the invention substantially as claimed except that loop is “teardrop shaped”. However, it has been held that mere changes in shape are a matter of obvious design choice that one having ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed is significant, solves any specific problem, or imparts any unexpected quality, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Here, Tremulis discloses a medical cannula (Fig. 7B) which likewise comprises a flexible member/guard configured to manipulate tissue as the cannula is inserted into the body (Par. 41), wherein the shape of the guard/flexible member may comprise a teardrop shape (see Fig. 7B). As such, a teardrop shape is merely one, specific, obvious, and predictable shape which the ordinary artisan would have found obvious, particularly given its use in the prior art, for the purposes of constructing the guard/flexible member of McCary to serve to protect tissue during insertion in a predictable and expected manner.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0074013 (“McCary”) as applied above, and further in view of U.S. Publication No. 2010/0168270 (“Guo”)
Regarding Claim 9, McCary discloses the invention substantially as claimed except that that flexible member is “polyamide”, only reciting “silicone or other suitable material”. However, Guo discloses a related medical catheter/cannula which comprises a soft, flexible atraumatic tip which may comprise a silicone based material or a polyamide based material to equal affect (Par. 4). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the flexible member of McCary to comprise polyamide, instead of silicone, as disclosed by Guo, in order to select a well-known material recognized in the prior art to be suitable for the construction of an atraumatic tip in place of a silicone material. It has been held that selecting a known material based upon its suitability for an intended purpose is obvious, requiring only routine and customary skill in the art to affect a predictable and expected outcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 02/10/2026