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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (Claims 1-8) in the reply filed on 7/13/2026 is acknowledged.
Claims 9-15 (Invention II) are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of using an introducer sheath, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/13/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/21/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “annular ridge” and “annular groove” of the elastomeric member (recited in claims 3-6) must be shown and labeled, or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bickhart (US 2017/0080200 A1) in view of Fisher (US 2009/0018508 A1).
Regarding claim 1, Bickhart discloses:
An introducer sheath assembly (see Fig. 1A), comprising:
a hub (housing 110, see Fig. 1A) comprising a proximal end region and a distal end region (see Fig. 1A) and a first lumen extending therethrough (first lumen 102, see Figs. 1C-1D), the first lumen including at least a proximal portion having a first width and a distal portion having a second width that is less than the first width (see Examiner’s Diagram of Fig. 1C below illustrating wherein first lumen 102 comprises a proximal portion having a first width and a distal portion having a second width; wherein the second width is less than the first width due to the tapered shape of the first lumen 102);
a cap (cap 130, see Figs. 1A and 1D) coupled to the proximal end region of the hub (see Fig. 1A and Para. [0038]) and comprising an interior member at least partially defining a second lumen (protrusions 132, see Figs. 1C-1D; space defined radially inward of protrusions 132 defining a “second lumen”);
an elastomeric member (elastomeric member 120, see Fig. 1C) having an hourglass shape (see Fig. 2C showing wherein the elastomeric member comprises an hourglass shape defined by one radially-smaller portion (sealing surface 154) disposed between two radially-larger sections (relief surfaces 162/164, see Fig. 2D); see also Para. [0053]) disposed in the proximal portion of the first lumen (see Fig. 1C; see also Para. [0035]-[0036]) between the interior member of the cap and the distal portion of the first lumen (see Fig. 1C and Para. [0035]-[0036], [0038] and [0042]), wherein the elastomeric member comprises a third lumen extending therethrough (channel 142, see Fig. 1C); and
an introducer sheath secured or securable to the distal end region of the hub (introducer sheath 180, see Fig. 6A).
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Examiner’s Diagram of Fig. 1C
However, while Bickhart discloses wherein the cap interior member(s) of the cap (i.e., protrusions 132) are configured to couple to corresponding recesses (i.e., recesses 122) within the elastomeric member (see Para. [0038]), Bickhart does not expressly disclose wherein the interior member(s) are disposed within the proximal portion of the first lumen.
In the same field of endeavor, namely introducer sheath assemblies, Fisher teaches an introducer sheath hub (hub 110, see Fig. 5) comprising a first lumen therein (cavity 130, see Fig. 5) and a valve (valve 150, see Figs. 4-5) disposed within the first lumen of the hub (see Fig. 6 and Para. [0030]); wherein the introducer sheath hub further comprises cap (cap 180, see Fig. 5) coupled to the proximal end of the hub (see Fig. 6 and Para. [0030]); wherein the cap comprises an interior member (pair of walls 190 defining a recess 196 therebetween; see Figs. 5-6) at least partially disposed in the first lumen of the hub (see Figs. 5-6) configured to engage a corresponding mating feature of the valve (recess 196 formed by walls 190 of cap 180 mates with wall 160 of the valve; see Figs. 5-6) to secure the cap to the valve while further securing the valve within the first lumen of the sheath hub (see Para. [0030]-[0032]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known valve securement mechanism for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418–19 (2007)) to have obtained the predictable result of substituting the protrusions (132) and corresponding recess (122) that form a securement mechanism between the cap and elastomeric member of Bickhart with the securement mechanism disclosed by Fisher (i.e., including the pair of walls 190 onto the cap while including corresponding mating wall 160 onto the elastomeric member) as a matter of obviousness in substituting one known securement mechanism for another. Since both securement mechanisms are configured to secure a cap of an introducer hub to the hub body while further securement a valve assembly therebetween, one of ordinary skill in the art would have expected the device of Bickhart to function equally well with either securement mechanism as both are disclosed to perform the same function. In the resulting combination, the interior member(s) of the cap of Bickhart (i.e., walls 190) would extend into the first lumen of the hub as shown in Fisher Figs. 5-6 to maintain the same configuration/relative length(s) once incorporated therein.
Claim(s) 2-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bickhart (US 2017/0080200 A1) in view of Fisher (US 2009/0018508 A1), further in view of Bonnette (US 2004/0210194 A1)
Regarding claim 2, the combination of Bickhart and Fisher discloses the invention of claim 1, Bickhart further discloses wherein the elastomeric member is selectively adjustable to at least decrease an interior width of the third lumen (see Para. [0063], [0065] and [0072]; channel 142 is flexible so as to expand and/or contract to accommodate various sized tools being inserted therethrough while maintaining a fluid-tight seal).
However, while Bickhart provides sufficient disclosure pertaining to wherein the third lumen (i.e., channel 142) is expandable and contractable, Bickhart does not expressly disclose wherein this adjustability is responsive to advancement of the interior member of the cap further into the proximal portion of the first lumen.
In the same field of endeavor, namely introducer sheath assemblies, Bonnette teaches an introducer sheath hub (manifold 12, see Figs. 1-2) comprising a first lumen therein (cavity 56, see Fig. 3) and a valve (valve 64, see Fig. 3) to be disposed within the first lumen of the hub (see Figs. 3 and 10); wherein the valve comprises a third lumen therein (see Figs. 4-5; a lumen is formed within valve 64 upon receipt of a surgical instrument therethrough which forcibly opens slits 96a-96n; see also Para. [0101] and [0103]); wherein the introducer sheath hub further comprises cap (nut 40, see Figs. 2-3 and 10) coupled to the proximal end of the hub (see Figs. 2-3 and 10); wherein the cap comprises an interior member (boss 68, see Fig. 10) at least partially disposed in the first lumen of the hub (see Fig. 10); wherein advancement of the cap further into the first lumen decrease an interior width of the valve and associated third lumen (see Para. [0093] mentioning wherein advancement of the nut distally into the first lumen adjusts the width of the valve and third lumen to accommodate a surgical instrument of a particular size passing therethrough while maintaining a fluid-tight seal).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Bickhart to allow distal movement of the cap further into the first lumen of the hub to cause tightening of the channel 142 of the elastomeric member as taught and suggested by Bonnette to, in this case, allow a user to manually adjust the width of the channel 142 of the elastomeric member to better accommodate a particular surgical instrument being pass therethrough so as to better maintain the fluid-tight seal (see Bonnette Para. [0093]).
Regarding claim 3, the combination of Bickhart, Fisher and Bonnette discloses the invention of claim 2, Bickhart, as modified by Bonnette further discloses wherein: the elastomeric member comprises two end regions (see Bickhart Fig. 2C), and outer surface (see Bickhart Fig. 2C), and a central region disposed between the two end regions (see Bickhart Fig. 2C) and comprising an inward oriented annular ridge in the third lumen (see Examiner’s Diagram of Bickhart Fig. 2C below showing an inwardly-oriented annular ridge extending into the space defined by relief surfaces 162/164) and an annular groove in the outer surface of the elastomeric member when the elastomeric member is in an undeformed orientation (annular recess 122, see Bickhart Fig. 2C); the elastomeric member is positioned in the proximal portion of the first lumen (see Bickhart Fig. 1C and Para. [0035]-[0036], [0038] and [0042]) such that advancing the interior member of the cap further into the proximal portion of the first lumen decreases a distance between the two end regions of the elastomeric member and increases a height of the inward oriented annular ridge (as modified by the teachings of Bonnette, advancement of the cap further into the first lumen causes compression of the elastomeric member; during compression, the relief surfaces 162/164 would elongate (i.e., increasing in lateral length), resulting in the inwardly-oriented annular ridge disposed therebetween to increase in height in the lateral direction), thereby decreasing the interior width of the third lumen (see Bonnette Para. [0093]).
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Examiner’s Diagram of Bickhart Fig. 2C
Regarding claim 4, the combination of Bickhart, Fisher and Bonnette discloses the invention of claim 3, Bickhart, as modified by Bonnette, further discloses wherein the cap is adjustably secured to the proximal end region of the hub and configured to advance the interior member of the cap and deform the elastomeric member until the inward oriented annular ridge substantially closes the third lumen of the elastomeric member (see Bonnette Para. [0093]; see also see Bickhart Fig. 4C showing wherein the channel 142 of the elastomeric member is substantially closed when no surgical device is passed therethrough).
Regarding claim 5, the combination of Bickhart, Fisher and Bonnette discloses claim 3, Bickhart, as modified by Bonnette, further discloses wherein the elastomeric member is secured to the cap and the hub such that the elastomeric member deforms to decrease a height the inward oriented annular ridge as the interior member of the cap is at least partially withdrawn from the proximal portion of the first lumen, thereby increasing the interior width of the third lumen (see Bonnette Para. [0093]; as the interior member(s) of the cap of Bickhart are drawn proximally out from the first lumen of the hub, the lateral length of relief surfaces 162/164 decrease as the longitudinal height increases, resulting in the annular ridge defined therebetween to be reduced in height in the lateral direction).
Regarding claim 6, the combination of Bickhart, Fisher and Bonnette discloses the invention of claim 3, Bickhart further discloses wherein the elastomeric member is configured to deform such that a height of the inward oriented annular ridge is decreased responsive to an elongate instrument being inserted through the third lumen of the elastomeric member, thereby forming a fluid tight-seal around the elongate instrument (see Para. [0063] and [0065] mentioning wherein the channel 142 of the elastomeric member may be increased in size to accommodate a large surgical instrument passing therethrough; should an instrument of sufficient size cause the second sealing surface 154 to expand, the annular ridge would thus be decreased in the lateral direction due to the lateral expansion of the second sealing surface).
Regarding claim 7, the combination of Bickhart, Fisher and Bonnette discloses the invention of claim 1, Bickhart further discloses wherein the elastomeric member is configured to deform responsive to an elongate instrument having a size of about 9F to about 20 F being inserted through the third lumen of the elastomeric member and form a liquid-tight seal around the elongate instrument (see Para. [0063]-[0065] mentioning wherein the elastomeric member is configured to deform in response to a surgical instrument being passed therethrough; the amount of deformation depending on the size of the surgical instrument; the channel 142 is reasonably capable of receiving an instrument having a size of between 9F and 20F).
Regarding claim 8, the combination of Bickhart and Fisher disclose all of the limitations of the invention of claim 1.
In the same field of endeavor, namely introducer sheath assemblies, Bonnette teaches an introducer sheath hub (manifold 12, see Figs. 1-2) comprising a first lumen therein (cavity 56, see Fig. 3) and a valve (valve 64, see Fig. 3) to be disposed within the first lumen of the hub (see Figs. 3 and 10); wherein the valve comprises a third lumen therein (see Figs. 4-5; a lumen is formed within valve 64 upon receipt of a surgical instrument therethrough which forcibly opens slits 96a-96n; see also Para. [0101] and [0103]); wherein the introducer sheath hub further comprises cap (nut 40, see Figs. 2-3 and 10) coupled to the proximal end of the hub (see Figs. 2-3 and 10) by a threaded connection (see Para. [0086]; threads 72 mate with threads 62); wherein the cap comprises an interior member (boss 68, see Fig. 10) at least partially disposed in the first lumen of the hub (see Fig. 10); wherein advancement of the cap further into the first lumen decrease an interior width of the valve and associated third lumen (see Para. [0093] mentioning wherein advancement of the nut distally into the first lumen adjusts the width of the valve and third lumen to accommodate a surgical instrument of a particular size passing therethrough while maintaining a fluid-tight seal).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Bickhart to include respective mating threads along the cap and hub as taught and suggested by Bonnette to, in this case, allow distal movement of the cap further into the first lumen of the hub (i.e., via movement along respective threads 62/72) to cause tightening of the channel 142 of the elastomeric member, allowing a user to manually adjust the width of the channel 142 of the elastomeric member to better accommodate a particular surgical instrument being pass therethrough so as to better maintain the fluid-tight seal (see Bonnette Para. [0093]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2004/0172008 A1 to Layer, US 2019/0183468 A1 to Sykes, US 2016/0331929 A1 to Lampropoulos, US 2008/0183163 A1 to Lampropoulos, US 2025/0367406 A1 to Lampropoulos, US RE45896 E to Stout, US 2015/0343179 A1 to Schumacher, US 2013/0165867 A1 to Isaacson and US 2007/0191775 A1 to Diep all disclose introducer hub assemblies comprising a cap having an interior member securing a cap to a hub body to secure a valve seal member therebetween.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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