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 § 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.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 5) that “McCary does not teach or disclose, expressly or inherently, a flexible member coupled to the distal end of the cannula ‘for tissue manipulation,” as required by Claim 1.” However, this is not persuasive. McCary discloses a flexible member (i.e. the “guard device” 84 or “plug” 116) which is described as being “a soft, compliant material, such as silicone or other suitable material” or “formed of silicone or other suitable soft, compliant material” (Par. 76 or 80). McCary discloses that the utility for these soft, compliant (i.e. flexible) members is to “protect delicate tissue, such as the retina, from damage” (Par. 76), serve as a “guard” to create a margin of safety to encountering ocular tissue (Par. 77) and “protecting delicate tissue that is not to be removed or damaged during a vitrectomy” (Par. 80) – subsets of a very broad utility of tissue “manipulation”.
Specifically, the function of “tissue manipulation" will cover any capability of the device to influence, move, adjust, or alter ANY of the ophthalmic tissues as part of the cannula system in ANY manner. In McCary the effect of “protecting delicate tissue that is not be removed or damaged” while permitting the removal of other tissues such as lens fragments and other tissues disrupted by the vibrations of the cannula system is inclusive to altering the torsional action and aspiration of the ophthalmic tissues (Par. 99). The flexible member disposed at the end of the cannula allows further manipulation by acting a protective bumper/guard to permit the cannula to push, prod, adjust…etc. tissues in an atraumatic fashion. Furthermore, Examiner notes that “tissue manipulation” is linked to the combined flexible member and cannula combination and no specific and particular manipulation function is tied to the flexible member alone and therefore is covered by the functions of the cannula as a whole. Specifically, in McCary the cannula assembly as a whole is configured to manipulate tissue in order to “disrupt and aspirate vitreous and other tissue from the eye” (Par. 2, 83), particularly with the guard simultaneously protecting other, non-target tissues.
Moreover the flexible member, being positioned on the distal end of the cannula is suited for pushing, probing, and moving tissue (as part of the cannula) by pushing the distal tip of the cannula against the tissue and using the combined unit to transfer force to the tissue. The instant claim does not specify any particular “manipulation” of the tissue, does not specify any structure not found in McCary or obvious to provide to McCary to render it better suited for performing its intended purpose, or specify any particular or specific capability not found in the “flexible member” of McCary. Again, the function of “tissue manipulation” is attributed to the combination of the flexible member and the cannula, in general, and not attributed to any particular function exclusive to a particular structure or shape of the flexible member itself. The claim does not require “grasping, lassoing, or membrane peeling” or any similar quantifications to the “tissue manipulation” which would require “significantly greater stiffness and deliberate engagement” which is not performable by the flexible member of McCary.
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 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
06/30/2026
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