DETAILED ACTION
Response to Amendment
The amendment filed March 9, 2026 has been entered. Claims 32, 35, 40, 41, 48, and 50-53 have been amended, claims 54-56 have been cancelled, and claims 57-59 have been newly added. Claims 32-53 and 57-59 are currently pending in the application.
Response to Arguments
Applicant's arguments filed March 9, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that Voss fails to teach a wall of the tube having a uniform thickness, the Examiner respectfully disagrees. Applicant points to the protrusion and depression surfaces of Voss to argue that the thickness at such locations changes. However, the tube of Voss is directly analogous to the tube of the instant invention. The protrusions of Voss (as depicted in Figure 13A) are the wall sections (1366), and the depressions (1368) are the vertices or apexes between the wall sections. This is identical in structure to instant tubing (e.g., Figure 11) with wall sections (1026) and depressions (1028). Therefore, it is unclear how Applicant can claim Voss fails to teach a uniform wall thickness and set forth such a feature in the claims which is identical to that of the instant invention. In addition, claim 32 as amended, fails to require the wall thickness to be uniform around the entire cross-section. Any portion of the wall along a segment (1366) of Voss is considered to be uniform along the segment (e.g., a small cross section can be taken at nearly the same point between two opposite segments; for example, there would be 6 equal thickness segments at the center of each segment 1366 between apexes). The rejection is considered to still meet the claim limitations as currently set forth and the rejection is maintained below.
Claim Objections
Claim50 is objected to because of the following informalities: line 3 should be amended to read: “along the length of the distal end portion….” Appropriate correction is required.
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) 32 and 34-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voss (US 2015/0088072).
Regarding claim 32, Voss discloses (Figures 1a and 13A-15) and a cannula, comprising: a tube (shaft 1310) comprising a proximal end (end adjacent housing 20), a distal end (insertion end), a longitudinal axis extending between the proximal and distal ends of the tube, and a wall enclosing a passage (any segment of 1366 may be considered part of a wall enclosing a passage) having a fixed length extending between the proximal and distal ends of the tube along the longitudinal axis of the tube (lumen of 1310, 1410, or 1510; Figures 13-15 disclose various embodiments of potential lumen cross-sections which all function in the same intended manner and are disclosed as interchangeable depending on the desired configuration; the basic polygon shape of Figure 13A is being used as a default, but the lobular shape of Figure 14 is equally applicable), the wall having a uniform thickness (there are a number of ways to interpret this limitation, but herein, the thickness of the wall at any segment 1366 is uniform from the internal surface to the external surface in that it is solid material and doesn’t vary across the material thickness at any section; the claim does not require the entire wall cross section to have the same thickness when measured at any point or section around the circumference); is configured to be inserted into a body (it’s an introducer sheath for use in a medical procedure); wherein the passage is configured to receive a medical instrument and permit insertion of the medical instrument into the body (¶ [0070]); wherein, along a first portion of the length of the tube including and extending proximally from the distal end of the wall and the passage of the tube define a first cross-sectional shape (octagonal as per Figure 13A) in a plane normal to the longitudinal axis; wherein the first cross-sectional shape comprises one of a polygonal shape (it’s disclosed as polygonal and depicted as hexagonal; ¶ [0175]) and a lobular shape (disclosed in Figures 14 and 15); wherein of the passage in a plane normal to the longitudinal axis; wherein, along a second portion of the length of the tube extending proximally from the first portion of the wall and the passage of the tube define a second cross-sectional shape in a plane normal to the longitudinal axis; and wherein the second cross-sectional shape is different from the first cross-sectional shape (¶ [0173] discloses the cross-section of shaft 1310 as being non-uniformly along a length of the sheath thereby providing disclosure of the cross-section varying along the length; see also ¶¶ [0180] and [0187] for the other embodiments; ¶ [0082] discloses the default lumen cross-section as circular and therefore if the polygonal or other cross-section only extends along a portion of the shaft length then the remaining portion would be disclosed as circular by default).
Regarding claim 34, Voss further discloses wherein the first cross-sectional shape comprises a polygon (¶ [0175]).
Regarding claim 35, Voss further discloses wherein: a circle inscribed within the first cross-sectional shape of the passage has a first diameter; the second cross-sectional shape of the passage is a circle having a second diameter; and the first diameter is smaller than the second diameter. It is noted, as set forth above, that Voss teaches the polygonal or lobular cross-section as extending only along a portion of the shaft and with the remaining shaft section being the default circular cross-section. In such an embodiment, the cross-section of the circular second portion would be larger than an inscribed circle of the polygonal or lobular cross-section as claimed assuming a constant inner diameter of the shaft.
Regarding claim 36, Voss further discloses wherein: portions of the passage outside the circle inscribed within the first cross-sectional shape are flow areas within the first cross-sectional shape; and portions of the passage adjacent the circle inscribed within the first cross-sectional shape are contact portions of the first cross-sectional shape arranged to contact a tool inserted within the cannula (¶¶ [0175]-[0178] disclose the general state of the device wherein the inner diameter portion contact the tool and the vertices allow for non-engagement thereby reducing friction; the area not in contact with the tool is capable of passing fluid around the tool).
Regarding claim 37, Voss further discloses a portion curved along the longitudinal axis (the outer body of shaft 1310 is cylindrical and therefore curved at a point on the longitudinal axis; the claim fails to specifically require the curvature to be in a plane aligned with the longitudinal axis).
Regarding claim 38, Voss further discloses wherein the second cross-sectional shape is a circle (¶ [0082] discloses the default shape of the lumen as circular and further discloses, as set forth above for claim 32, that the alternate cross-sectional portion only extends along a portion of the length and with such a disclosure, the remaining portion of the lumen would be circular as the default lumen cross-section).
Regarding claim 39, Voss further discloses the cross-section as a Reuleaux polygon (the embodiment of Figure 15 discloses a Reuleaux triangle as claimed; ¶ [0189]).
Regarding claim 40, Voss further discloses the cross section as a lobular shape having alternating convex and concave segments (Figure 14; ¶¶ [0182]-[0185]).
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.
Claim(s) 33, 41-48, 50, and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss.
Regarding claims 33 and 59, Voss discloses the claimed invention substantially as set forth above for claim 34, but fails to explicitly the first and second shapes have outer wall perimeters of equal length. However, it would have been obvious to one of ordinary skill in the art to make the second cross-section larger than the polygonal or lobular cross-section so as to allow a tool to be inserted while maintaining reduced friction before the tool engages the narrower alternate cross-section. One of ordinary skill in the art would have found such a feature is a design choice which would be obvious absent persuasive evidence that the claimed configuration was significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The perimeter of the circular cross-section would have to be approximately 34% larger than an inscribed circle of the octagonal embodiment to result in the claimed equal length. Such a modification would have been an obvious design choice which would have maintained the function of the device of Voss in reducing the friction of the device. It is further noted that Voss discloses varying the diameter of the shaft along the length in any desired manner (e.g., ¶ [0077]). The same rejection can be applied to claim 59, wherein it would have been obvious to modify the lengths of the first and second portions to be from about 0.75 inches to about 1.25 inches depending on the end use of the device. There is no evidence of record that establishes that changing the length of these sections would result in a different in function of the device of Voss. Further, one of ordinary skill in the art, faced with modifying the device of Voss would have had a reasonably expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths. Furthermore, applicant has not disclosed that the claimed range solves any stated problem and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the length of the sections to be with the range of 0.75 to 1.25 inches as an obvious matter of design choice within the skill of the art. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). See also MPEP § 2144.04(IV)(A).
Regarding claim 41, Voss discloses a system, comprising: a cannula (1310, 1410, or 1510; all embodiments are disclosed as simple variations of the lumen and achieve the same purpose) and a surgical tool inserted through the cannula (e.g., ¶¶ [0178], [0185], and [0192] disclose the cross-sectional shapes of Figures 13-15 as allowing for minimizing friction with a tool pass through the lumen); wherein the cannula comprises a tube (Figure 1A); wherein the tube comprises a proximal end and a proximal end portion adjacent the proximal end, a distal end and a distal end portion adjacent the distal end, a longitudinal axis extending between the proximal and distal ends of the tube, and wall enclosing a passage (forming lumen of 30 in Figure 1A) having a fixed length extending between the proximal and distal ends of the tube (Figure 1A), the wall having a uniform thickness (there are a number of ways to interpret this limitation, but herein, the thickness of the wall at any segment 1366 is uniform from the internal surface to the external surface in that it is solid material and doesn’t vary across the material thickness at any section; the claim does not require the entire wall cross section to have the same thickness when measured at any point or section around the circumference): wherein along a length of the distal end portion of the tube the passage define a first cross-sectional shape in a plane normal to the longitudinal axis (lumen of 1310, 1410, or 1510; Figures 13-15 disclose various embodiments of potential lumen cross-sections which all function in the same intended manner and are disclosed as interchangeable depending on the desired configuration; the basic polygon shape of Figure 13A is being used as a default, but the lobular shape of Figure 14 is equally applicable); wherein along a length of the proximal end portion of the tube the wall and the passage of the tube define a second cross-sectional shape in a plane normal to the longitudinal axis; wherein the second cross-sectional shape is different than the first cross-sectional shape; wherein the surgical tool comprises a shaft, and the shaft is inserted within the passage (¶ [0173] discloses the cross-section of shaft 1310 as being non-uniformly along a length of the sheath thereby providing disclosure of the cross-section varying along the length; see also ¶¶ [0180] and [0187] for the other embodiments; ¶ [0082] discloses the default lumen cross-section as circular and therefore if the polygonal or other cross-section only extends along a portion of the shaft length then the remaining portion would be disclosed as circular by default); wherein the passage comprises an outer perimeter, and a circle inscribed within the first cross-sectional shape of the passage has a first diameter that defines a first clearance between the outer perimeter of the passage and the shaft of the surgical tool (see e.g., ¶ [0178] which discloses the engagement of the tool with the lumen of Figure 13A, but is the same engagement for all disclosed embodiments); wherein the second cross-sectional shape of the passage defines a second clearance between the outer perimeter of the passage and the shaft of the surgical tool (a circular clearance would define a different clearance for the tool than a polygonal or lobular one). Voss fails to explicitly disclose wherein the second clearance is larger than the first clearance, however, Voss discloses (e.g., ¶¶ [0173], [0180], and [0187]) non-uniformly distributing the lumen along the length of the shaft and therefore a portion of the shaft, in a non-uniformly distributed embodiment, would be circular as set forth above. It would have been obvious to one of ordinary skill in the art to make the second cross-section larger than the polygonal or lobular cross-section so as to allow a tool to be inserted while maintaining reduced friction before the tool engages the narrower alternate cross-section. One of ordinary skill in the art would have found such a feature is a design choice which would be obvious absent persuasive evidence that the claimed configuration was significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Expanding the circular proximal cross-section would have maintained the desired function of the device of Voss without requiring the cross-section to be formed along the entire length of the tubing which is a feature disclosed by Voss as set forth above.
Regarding claim 42, Voss further discloses wherein the first cross-sectional shape comprises a polygon (¶ [0175]).
Regarding claim 43, Voss further discloses the cross-section as a Reuleaux polygon (the embodiment of Figure 15 discloses a Reuleaux triangle as claimed with rounded vertices; ¶ [0189]).
Regarding claim 44, Voss further discloses the cross-section as a Reuleaux polygon (the embodiment of Figure 15 discloses a Reuleaux triangle as claimed with rounded vertices; ¶ [0189]).
Regarding claim 45, Voss further discloses the first cross-section as oval (¶ [0067]).
Regarding claim 46, Voss further discloses wherein the second cross-sectional shape is a circle (¶ [0082] discloses the default shape of the lumen as circular and further discloses, as set forth above for claim 32, that the alternate cross-sectional portion only extends along a portion of the length and with such a disclosure, the remaining portion of the lumen would be circular as the default lumen cross-section).
Regarding claim 47, Voss further discloses the first cross-sectional shape as non-circular (e.g., Figures 13A-15; ¶ [0067]).
Regarding claim 48, Voss further discloses wherein the first cross-section shape defines a plurality of flow areas defined between the shaft and the outer perimeter of the passage; and each individual one of the plurality of flow areas is a corresponding individual flow path between the wall of the tube and the shaft through the passage (the embodiments of Figures 13A-15 are intended to minimize friction with a tool extending therethrough and as such the vertices of the polygonal or lobular shape will not engage with the tool extending therethrough as it is not a matched cross-section; in this manner there will be area around the tool to allow for fluid passage; the device is intended to receive fluid within the lumen as per ¶¶ [0073] and [0074]; the apexes of Voss are fully capable of allowing any fluid to flow through the lumen and around the instrument; the claim should require the gas source connected to the tube in order to further limit the structure to perform the claimed function explicitly).
Regarding claim 50, Voss discloses the claimed invention substantially as set forth above for claim 41, but fails to explicitly disclose the outer surface of the wall along the length of the distal end portion of the tube as having a perimeter equal in length to the outer surface of the wall along the length of the proximal end portion of the tube. However, it would have been obvious to one of ordinary skill in the art to form the segments to have the same perimeter as the polygonal or lobular cross-section so as to allow for introduction of the tool therethrough while maintaining the desired reduction in friction of the lumen with the tool as taught by Voss. Such a feature is a design choice which one of ordinary skill would have found obvious absent persuasive evidence that the claimed configuration was significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In this manner, the cross-section of Figure 13A might represent the first perimeter and the circular proximal section defining the second cross-section could be formed with a perimeter of approximately 34% larger than that of the octagonal one to form equal perimeters along the length of the shaft for receiving the tool in the disclosed reduced friction environment.
Claim(s) 49 and 51-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss in view of Williams et al. (US 2017/0274154).
Regarding claims 49 and 51, Voss teaches the claimed invention substantially as set forth above with respect to the circular and polygonal cross-sections of the tube, but fails to explicitly disclose an insufflation fitting or gas source for use with the device.
Williams teaches an apparatus comprising: a cannula tube (19) comprising a proximal end, a distal end, an inner wall between the proximal and distal ends (13a-f) (Figure 3), and a first passage (20) defined by the inner wall; and an insufflation source (12;Figure 1) fitting at the proximal end of the tube and comprising a second passage joining the first passage of the tube (see ¶ [0021] “ In this example a tube 40, which is connected to a source of insufflation gas, supplies the insufflation gas to the patient 39 through the trocar cannula 13 which also contains the medical instrument therein.” The prior art discloses a second passage (40) that connects to a source of insufflation gas in Figure 5).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Voss to comprise an insufflation fitting and gas source so as to allow for insufflation of a target site during a procedure as taught by Williams.
Regarding claim 52, Voss teaches the system of claim 41 as set forth above and wherein the first cross-sectional shape is polygonal (Figure 13A) but fails to explicitly disclose the particulars of the tool within the lumen.
Williams further teaches wherein the apparatus further comprises an instrument shaft (36) (Fig. 2B) extending through the first passage (20) (Fig. 3); the instrument shaft comprises an outer surface (36a) (Fig. 6); and the outer surface of the instrument shaft contacts the inner surface of the tube along a contact line (see annotated Fig. 6) at the polygonal cross sectional shape (see ¶ [0026] “the hexagonal cannula 13 prevent any of the peripheral passages from being blocked by shaft 36 if the shaft is located in an askew position within the lumen in cannula 13 since the shaft 36 is centrally constrained by web faces 14a-14f).
Regarding claim 53, Williams further teaches the apparatus of claim 52, wherein: the outer surface of the instrument shaft contacts the inner surface of the wall of the tube along a second contact line at the polygonal cross section of the tube (see Fig. 6 of Williams, the instrument 36 is fully capable of engaging the wall during insertion or movement of the outer shaft relative to the inner shaft; the claim does not require the contact between the shaft of the instrument to be intentional during a procedure to ensure gas flows around the instrument and is blocked by the engagement of the instrument shaft with the lumen surface).
Claim(s) 57 and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss in view of Smith (US 2007/0016237).
Regarding claim 57, Voss discloses the invention as set forth above for claim 32, but fails to disclose the tube as being formed from a ductile metal material.
Smith teaches a trocar assembly wherein the tube (1000) is formed from a ductile metal material (¶ [0041] discloses the sleeve as formed from a biocompatible metal and all metal will have some level of ductility as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the tubing of the device of Voss to be formed from ductile metal, as taught by Smith, since Smith teaches that such a material is known for use in insufflation cannula assemblies used within a patient during a procedure and are designed to be biocompatible and to receive an instrument within the tube (Figure 2).
Regarding claim 58, In accordance to MPEP § 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e., the cross-sectional shape of the passage, does not depend on its method of production, i.e., made by deformation of the wall of the tube. See In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985).
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 JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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