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 .
Response to Amendment
The amendment filed on 12/3/2025 has been entered. Claims 1-20 are pending in the application. The amendments to the claims overcome each and every objection previously set forth in the Non-Final Office Action mailed on 9/16/2025. The amendments to claim 11 overcome the provisional nonstatutory double patenting rejection of the claim.
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Feinberg et al. (US 2008/0097391 A1) in view of Snyder et al. (US 2003/0009208 A1) and further in view of Suchdev et al. (US 2023/0277748 A1).
Regarding claim 11, Feinberg discloses a cannula system (see Figs. 1-15) comprising:
an inner tube (catheter 6) slidingly engaged inside of at least a portion of a rigid outer tube (inner tubular member 4, see par. [0093]) (see Figs. 1-15, par. [0093]-[0095] and [0100]), the rigid outer tube (inner tubular member 4) extending to an outlet port (outlet at distal end of inner tubular member 4, see Fig. 9) from a handle distal end (distal end of lap collar 28) of a handle (lap collar 28) (see Figs. 1-13, par. [0100]), wherein the handle distal end (distal end of lap collar 28) and the rigid outer tube (inner tubular member 4) have an immobile relationship (see Figs. 1-13, par. [0101], lap collar 28 is immobile relative to inner tubular member 4 via fixation by a set screw 50), the inner tube (catheter 6) defined between a distal tube end (distal tip portion 8) and a proximal tube end (proximal end 14) having an irrigation and suction port (opening 16) (see Fig. 9, par. [0094], note: catheter 6 is used for conveying medical fluids thus opening 16 can be used for irrigation and suction);
a distal portion of said inner tube (catheter 6) defines an arced section (see Figs. 1-2, par. [0095]-[0096], catheter 6 can be formed of rigid shape memory materials that have a pre-shaped curvature only at the distal end 8) that has at least one arc shapе when not inside of the rigid outer tube (inner tubular member 4) (see Figs. 1-2 and 14- 15, par. [0093]-[0096] and [0100], retracting the inner tubular member 4 to expose the distal end 8 of the catheter 6 allows the catheter 6 to assume its arced shape).
However, Feinberg fails to state a suction-irrigation tip fixedly attached to the inner tube essentially at the distal tube end, the suction-irrigation tip in constant fluid communication with the irrigation and suction port; and that at least one through cut confined to the distal portion of the inner tube defines the arced section, the at least one through cut is sealed with a flexible sleeve.
Snyder teaches a cannula system (see Figs. 1-5) wherein at least one through cut (cuts 110) confined to the distal portion (portions 113+114+120) of said tube (body 105) define the arced section (see Fig. 1, par. [0033]), the at least one through cut (cuts 110) are sealed with a flexible sleeve (liner 203) (see Figs. 1-5, par. [0035]-[0036]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner tube of the cannula system of Feinberg to include at least one through cut confined to the distal portion of the inner tube to define the arced section, the at least one through cut is sealed with a flexible sleeve, as suggested by Snyder, in order to customize the geometry and spacing (and thus the flexibility characteristics) of the through cut(s) of the arced section to meet the flexibility requirements of a particular surgical cannula system (see Snyder par. [0033]) while reducing leakage and friction (see Snyder par. [0035]-[0036]).
However, modified Feinberg still fails to state a suction-irrigation tip fixedly attached to the inner tube essentially at the distal tube end, the suction-irrigation tip in constant fluid communication with the irrigation and suction port.
Suchdev teaches a cannula system (see Figs. 1-2) comprising a suction-irrigation tip (tip 14) fixedly attached to the inner tube (tubing 12) essentially at the distal tube end (see Figs 1-2, par. [0052]-[0055]), the suction-irrigation tip (tip 14) in constant fluid communication with the irrigation and suction port (opening at proximal end of tubing 12 where tubing 12 splits into an irrigation line and a suction line 30) (see Figs. 1-2, par. [0052]-[0055]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula system of modified Feinberg to include a suction-irrigation tip fixedly attached to the inner tube essentially at the distal tube end, the suction-irrigation tip in constant fluid communication with the irrigation and suction port, as taught by Suchdev, in order to provide a tip which has a different shape than the remainder of the tube which can allow the surgeon to grasp the tip with a tool to aid in manipulating the tip and to accommodate side ports which can provide suction relief (see Suchdev par. [0052]-[0055]).
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Feinberg et al. (US 2008/0097391 A1) in view of Snyder et al. (US 2003/0009208 A1) and further in view of Suchdev et al. (US 2023/0277748 A1), as applied to claim 11 above, and further in view of Mathena et al. (US 2018/0132837 A1).
Regarding claim 12, modified Feinberg teaches the cannula system of claim 11 substantially as claimed. However, modified Feinberg fails to state a nitinol wire disposed within a sidewall of the inner tube, the nitinol wire extending at least partially along the arced section, the nitinol wire configured to cause the arced section to bend into a predetermined shape upon reaching a target temperature.
Mathena teaches a cannula system (see Figs. 1, 4, and 6) comprising a nitinol wire (nitinol wire, see par. [0047]) disposed within a sidewall of the inner tube (body portion 404) (see par. [0047], the nitinol wire is embedded within body portion 404 at least at curved section 440), the nitinol wire (nitinol wire, see par. [0047]) extending at least partially along the arced section (curved section 440) (see par. [0047]), the nitinol wire (nitinol wire, see par. [0047]) configured to cause the arced section (curved section 440) to bend into a predetermined shape upon reaching a target temperature (see par. [0047]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula system of modified Feinberg to include a nitinol wire disposed within a sidewall of the inner tube, the nitinol wire extending at least partially along the arced section, the nitinol wire configured to cause the arced section to bend into a predetermined shape upon reaching a target temperature, as taught by Mathena, in order to allow further selectivity of the flexibility characteristics of the arced section depending on the temperature of the system (see Mathena par. [0047]).
Regarding claim 13, modified Feinberg teaches the cannula system of claim 12 substantially as claimed. Modified Feinberg further teaches wherein the nitinol wire (Mathena, nitinol wire, par. [0047]) is disposed within a wire passageway extending along a thickened wall portion of the inner tube (see previous modifications in rejection of claim 12 above; see Mathena par. [0047], a nitinol wire is embedded within the inner tube such that it would be disposed within a passageway/space for the nitinol wire).
Regarding claim 14, modified Feinberg teaches the cannula system of claim substantially as claimed. However, modified Feinberg fails to state a nitinol sleeve disposed within the inner tube, the nitinol sleeve extending at least partially along the arced section, the nitinol sleeve configured to cause the arced section to bend into a predetermined shape upon reaching a target temperature.
Mathena teaches a cannula system (see Figs. 1, 4, and 6) comprising a nitinol sleeve (nitinol hypotube, see par. [0047]) disposed within the inner tube (body portion 404) (see par. [0047], the nitinol hypotube is embedded within body portion 404 at least at curved section 440), the nitinol sleeve (nitinol hypotube, see par. [0047]) extending at least partially along the arced section (curved section 440) (see par. [0047]), the nitinol sleeve (nitinol hypotube, see par. [0047]) configured to cause the arced section (curved section 440) to bend into a predetermined shape upon reaching a target temperature (see par. [0047]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula system of modified Feinberg to include a nitinol sleeve disposed within the inner tube, the nitinol sleeve extending at least partially along the arced section, the nitinol sleeve configured to cause the arced section to bend into a predetermined shape upon reaching a target temperature, as taught by Mathena, in order to allow the flexibility characteristics of the arced section to be selectively changed depending on the temperature of the system (see Mathena par. [0047]).
Regarding claim 15, modified Feinberg teaches the cannula system of claim 14 substantially as claimed. Modified Feinberg further teaches wherein the nitinol sleeve (Mathena, nitinol hypotube, par. [0047]) tightly conforms to an inner surface of the inner tube and is secured to the inner surface of the inner tube (see previous modifications in rejection of claim 14 above; see Mathena par. [0047], a nitinol hypotube is embedded within the inner tube such that it would be conforming/secured to the wall of the inner tube).
Regarding claim 16, modified Feinberg teaches the cannula system of claim 14 substantially as claimed. Modified Feinberg further teaches wherein the nitinol sleeve (Mathena, nitinol hypotube, par. [0047]) seals the at least one through cut (Snyder, cuts 110), which prevents fluid communication through the at least one through cut (see previous modifications in rejection of claim 14 above; see Mathena par. [0047], see Snyder par. [0035]-[0036], a nitinol hypotube is embedded within the inner tube which has through cuts and is fluidically sealed).
Allowable Subject Matter
Claims 1-10 and 17-20 are allowable.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to independent claim 1, the prior art of record fails to disclose or render obvious before the effective filing date of the claimed invention the cannula arrangement as claimed, specifically including the combination of a rigid outer tube; and an inner tube, wherein an outer surface circumference of the inner tube confronts and slidingly engages an inner surface of the rigid outer tube; the inner tube comprising a flexible tube segment interposed between a suction-irrigation tip substrate and a rigid inner tube segment, the rigid inner tube segment extending from the flexible tube segment to the proximal tube end.
The closest prior art of record is Barrington et al. (US 2010/0010524 A1), Nita et (US 5,951,539 A), and Mathena et al. (US 2018/0132837 A1).
Barrington teaches a cannula arrangement (see Figs. 1-2d) comprising: a rigid outer tube (sheath 114) and an inner tube (evacuation tube 112) slidable within the rigid outer tube (sheath 114) and having a flexible tube segment (distal end of evacuation tube 112) (see Figs. 1-2d, par. [0059]). Nita teaches a cannula arrangement (see Figs. 1 and 9-10) comprising a flexible tube segment (bendable section, see Fig. 1, col. 9 lines 54-61) comprising a spiral through-cut (coils 522/524) extending through a sidewall of the inner tube (depicted as 530 in Fig. 9 and 546 in Fig. 10) along at least a portion of the flexible tube segment (bendable section, see Fig. 1, col. 9 lines 54-61), the flexible tube segment configured to flex relative to a longitudinal axis of the inner tube (depicted as 530 in Fig. 9 and 546 in Fig. 10) (see Figs. 1 and 9-10, col. 9 lines 54-61, col. 14 lines 51-57). Mathena teaches a cannula arrangement (see Figs. 1, 4, and 6) comprising a nitinol wire (nitinol wire, see par. [0047]) disposed within a sidewall of the inner tube (body portion 404) (see par. [0047], the nitinol wire is embedded within body portion 404 at least at curved section 440), the nitinol wire (nitinol wire, see par. [0047]) extending at least partially along the flexible tube segment (curved section 440) (see par. [0047]), the nitinol wire (nitinol wire, see par. [0047]) configured to cause the flexible tube segment (curved section 440) to bend into a predetermined shape upon reaching a target temperature (see par. [0047]).
However, pursuant to the Board Decision on Appeal of 7/14/2025 in the parent application 18/415,846, Barrington fails to teach the combination of a rigid outer tube and an inner tube slidable within the rigid outer tube; the inner tube comprising a flexible tube segment and a rigid inner tube segment, the rigid inner tube segment extending from the flexible tube segment to the proximal tube end. Neither Nita nor Mathena make up for this deficiency.
Claims 2-10 are allowable by virtue of their dependency on allowable claim 1.
In regards to independent claim 17, the prior art of record fails to disclose or render obvious before the effective filing date of the claimed invention the cannula as claimed, specifically including the combination of an inner tube slidingly engaged inside of at least a portion of a rigid outer tube, the inner tube comprising a flexible tube segment interposed between a suction-irrigation tip substrate and a rigid inner tube segment, the rigid inner tube segment extending from the flexible tube segment to a proximal tube end of the inner tube, the rigid outer tube and the rigid inner tube segment share a common central axis.
The closest prior art of record is Barrington et al. (US 2010/0010524 A1), Nitsan et al. (US 2010/0298773 A1), and Mathena et al. (US 2018/0132837 A1).
Barrington teaches a cannula (see Figs. 1-2d) comprising: an inner tube (evacuation tube 112) slidingly engaged inside of at least a portion of a rigid outer tube (sheath 114), the inner tube (evacuation tube 112) having a flexible tube segment (distal end of evacuation tube 112) (see Figs. 1-2d, par. [0059]). Nitsan teaches a cannula (see Fig. 14) comprising a suction-irrigation tip (widened part of distal head region 90) attached to and essentially covering the suction-irrigation tip substrate (narrowed part of distal head region 90), the suction-irrigation tip (widened part of distal head region 90) does not fit into the rigid outer tube (sleeve 96) (see Fig. 14, par. [0151]). Mathena teaches a cannula (see Figs. 1, 4, and 6) comprising an elongated nitinol member (nitinol wire, see par. [0047]) extending along at least a portion of the flexible tube segment (curved section 440) (see par. [0047], the nitinol wire is embedded within body portion 404 at least at curved section 440), wherein the elongated nitinol member (nitinol wire, see par. [0047]) is configured to cause the flexible tube segment (curved section 440) to bend into a predetermined shape upon reaching a target temperature (see par. [0047]).
However, pursuant to the Board Decision on Appeal of 7/14/2025 in the parent application 18/415,846, Barrington fails to teach the combination of a rigid outer tube and an inner tube slidable within the rigid outer tube; the inner tube comprising a flexible tube segment and a rigid inner tube segment, the rigid inner tube segment extending from the flexible tube segment to the proximal tube end. Neither Nitsan nor Mathena make up for this deficiency.
Claims 18-20 are allowable by virtue of their dependency on allowable claim 17.
Response to Arguments
Applicant’s arguments with respect to claim 11 have been considered but are moot. The amendments to claim 11 changed the scope of the “suction-irrigation tip” and thus necessitated the new ground(s) of rejection presented above.
Applicant’s arguments with respect to claims 12-16 have been considered but are not persuasive. Applicant argues that the reference in par. [0047] of Mathena stating “a nitinol wire or nitinol hypotube is embedded within the accessory sheath body portion 404” is vague and does not teach each of the different structural embodiments of claims 12-16. However, the Examiner disagrees. Claims 12-13 are drawn to a nitinol wire within the sidewall of the inner tube and claims 14-16 are drawn to a nitinol sleeve disposed within the inner tube. Mathena clearly teaches both configurations of the nitinol wire of claims 12-13 (“a nitinol wire…is embedded within the accessory sheath body portion 404 (e.g., at least the curved section 440) to bias the curved section 440 toward the default shape in at least some conditions (e.g., at certain temperatures)”) and the nitinol sleeve of claims 14-16 (“or nitinol hypotube is embedded within the accessory sheath body portion 404 (e.g., at least the curved section 440) to bias the curved section 440 toward the default shape in at least some conditions (e.g., at certain temperatures)”). Thus, Applicant’s arguments do not appear to be persuasive as Mathena still appears to teach these limitations.
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.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783