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
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 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) 12-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2022/016059 (hereinafter “Neumann”).
Referring to claim 12, Neumann discloses a medical introducer (Figs. 50-52, 53D and Fig. 64. Figs. 53D and 64 are reproduced below, ¶¶ [0206]-[0213] and [0224]-[0238]) comprising:
an introducer hub 162, 1030 (Figs. 53D and 64); and
an introducer shaft 162, 1010 extending distally from the introducer hub, the introducer shaft comprising: a first distal portion (the region at lead line 162 as shown in Fig. 53D, the region at lead line 1000 as shown in Fig. 64) comprising a first externally oriented surface portion defining at least a portion of the first distal portion having a first diameter; a second distal portion (balloon 164 as shown in Fig. 53D and protrusion 1020 as shown in Fig. 64) proximal of the first distal portion, the second distal portion comprising a second externally oriented surface portion defining at least a portion of the second distal portion having a second diameter (diameter of balloon 164 as shown in Fig. 53D and diameter of the region at lead line 1020 as shown in Fig. 64) that is larger than the first diameter; and an externally oriented transition surface portion (Fig. 53D shows distal surface of balloon 164 is perpendicular to longitudinal axis of the catheter. Fig. 64 shows protrusion 1020 has a surface transverse or substantially perpendicular to the outer surface of region at lead line 1000) extending between the first and second externally oriented surface portions, the externally oriented transition surface portion being angled relative to the second externally oriented surface portion.
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Referring to claim 13, Neumann discloses the introducer of claim 12, wherein the externally oriented transition surface portion is perpendicular to the second externally oriented surface portion (Fig. 53D and Fig. 64 show protrusion 164, 1020 has a surface that is substantially perpendicular to the outer surface of catheter).
Referring to claim 15, Neumann discloses the introducer of claim 12, wherein a distal end of the second distal portion 164, 1020 is disposed around a portion of a circumference of the introducer shaft.
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beal et al. (US 2009/0105652, hereinafter “Beal”).
Referring to claim 12, Beal discloses a medical introducer 30 (Figs. 1 and 4-5, ¶¶ [0022] and [0032]-[0034]. Fig. 5 is reproduced below) comprising:
an introducer hub 30A (Fig. 4); and
an introducer shaft extending distally from the introducer hub, the introducer shaft comprising: a first distal portion (the region at lead line 62 as shown in Fig. 5) comprising a first externally oriented surface portion defining at least a portion of the first distal portion having a first diameter; a second distal portion (the region proximal of region 64 as shown in Fig. 5) proximal of the first distal portion, the second distal portion comprising a second externally oriented surface portion defining at least a portion of the second distal portion having a second diameter that is larger than the first diameter; and an externally oriented transition surface portion (the region at lead line 64 as shown in Fig. 5) extending between the first and second externally oriented surface portions, the externally oriented transition surface portion 64 being angled relative to the second externally oriented surface portion.
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Referring to claim 14, Beal discloses the introducer of claim 12, wherein a remaining portion of the introducer shaft proximal of the second distal portion 64 comprises the second diameter (Figs. 4-5 shows the remaining portion of the introducer shaft proximal of the second distal portion 64 comprises the second diameter).
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.
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) 1, 3-5, 3-11 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martinez et al. (US 5,453,090, hereinafter “Martinez”).
Referring to claim 1, Martinez discloses a medical access system (Fig. 1 is reproduced and annotated below. Col. 3, ln. 55 to col. 5, ln. 5) comprising:
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an expandable access sheath 18 comprising: a sheath hub (the region near lead line 30 as shown in Fig. 1); and a sheath shaft (the region at lead line 18 as shown in Fig. 1) extending distally from the sheath hub and comprising an expandable distal end portion 32, the sheath shaft comprising a shaft delivery lumen extending therethrough; and
an introducer (balloon catheter 14 as shown in Fig. 1 and 3-5) comprising an introducer shaft 15, the introducer shaft being configured to be at least partially disposed within the shaft delivery lumen while the expandable distal end portion is in a closed state, the introducer shaft comprising: a first distal portion (see annotated figure above) comprising a first diameter; a second distal portion (see annotated figure above) proximal of the first distal portion, the second distal portion comprising a second diameter larger than the first diameter; and an externally oriented transition surface portion (see annotated figure above) extending between a first externally oriented surface portion defining a portion of the first distal portion having the first diameter and a second externally oriented surface portion defining a portion of the second distal portion having the second diameter, the externally oriented transition surface portion and the second externally oriented surface portion forming an angle.
Martinez discloses the invention substantially as claimed except for disclosing the angle is between 80 degrees and 100 degrees. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided an angle between 80 degrees and 100 degrees since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).
Referring to claim 3, the modified device of Martinez discloses the system of claim 1, wherein the first and second externally oriented surfaces are parallel to a longitudinal axis of the introducer (see annotated figure above).
Referring to claim 4, the modified device of Martinez discloses the system of claim 1, and the first diameter and the second diameter have a ratio between 1:6. The modified device of Martinez fails to disclose the ratio between 1:3 and 2:3. However, it is well known in the art that blood vessel in the brain or around the heart is very small, thus, it would have been obvious to use the catheter to deliver small stent to treat small blood vessel. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided to use the same catheter to deploy small stent with the ratio of 1:3 or 2:3 to small blood vessel in the brain or around the heart since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).
Referring to claim 5, Martinez discloses the system of claim 1, wherein the introducer shaft further comprises a proximal portion proximal of the second distal portion (the portion at lead lines 12, 14 as shown in Fig. 1 above), the proximal portion having a third diameter smaller than the second diameter.
Referring to claim 7, Martinez discloses the system of claim 1, wherein, while the expandable distal end portion 32 (Fig. 1) is in the closed state, a distal end of the second distal portion is configured to be positioned within the shaft delivery lumen at a position proximal of a proximal end of an inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion (Fig. 1, which is reproduced and annotated above).
Referring to claim 8, Martinez discloses the system of claim 1, wherein a distal end of the second distal portion (see annotated figure above) frictionally fits against a respective inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion (Figs. 1 and 3-5 show the device of Martinez inherently discloses this limitation).
Referring to claim 9, Martinez discloses the system of claim 8, wherein, while the expandable distal end portion 32 is in the closed state, the distal end of the second distal portion (see annotated figure above) is configured to be positioned against a proximal end or a proximal portion of the inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion (Figs. 1 and 3-5 show the device of Martinez inherently discloses this limitation).
Referring to claim 10, Martinez discloses the system of claim 1, wherein a distal end of the second distal portion (see annotated figure above) is a circumferential portion extending circumferentially around the introducer shaft (Fig. 1).
Referring to claim 16, Martinez discloses a method of delivering a medical device (stent device 24 as shown in Figs. 1 and 3-5. Fig. 1 is reproduced and annotated below. Col. 3, ln. 55 to col. 5, ln. 5), the method comprising:
providing an expandable access sheath 18 comprising a sheath shaft that includes an expandable distal end portion in a closed state (Figs. 1 and 3), the sheath shaft comprising a shaft delivery lumen extending therethrough; and
providing an introducer (balloon catheter inside the delivery lumen of sheath 18 as shown in Figs. 1 and 3-5) comprising an introducer shaft 14 disposed at least partially within the shaft delivery lumen, the introducer shaft comprising an externally oriented transition surface portion (see annotated figure below) extending between a first distal portion (see annotated figure below) and a second distal portion, the second distal portion comprising a diameter larger than that of the first distal portion and being proximal of the first distal portion, the externally oriented transition surface portion and a second externally oriented surface portion of the second distal portion angled relative to one another;
inserting at least a portion of the sheath shaft and the introducer shaft into a bodily lumen; and
pulling the expandable access sheath relative to the introducer to allow the distal end of the introducer pushing against an inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion to thereby cause the expandable distal end portion to transform to an open state. (Figs. 3-5, col. 4, lns. 37-55).
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Martinez fails to disclose the step of advancing the introducer relative to the sheath shaft 18 and pushing a distal end of the second distal portion of the introducer shaft against an inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion to thereby cause the expandable distal end portion to transform to an open state. However, Martinez discloses the step of pushing the introducer forward is also well known in the art (“The Pinchuk U.S. Pat. No. 5,019,090 discloses a radially expandable endoprosthesis (stent) and the like which is in a sheath having an open distal end. A cylindrical pusher is located within the sheath for pushing out the stent into an area of a lesion in a blood vessel.” (col. 2, lns. 7-12). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided the step of advancing the introducer relative to the sheath shaft 18 and pushing a distal end of the second distal portion of the introducer shaft against an inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion to thereby cause the expandable distal end portion to transform to an open state since this step is well known in the art.
Referring to claim 17, the modified method of Martinez discloses the method of claim 16, wherein pushing the distal end of the second distal portion against the inner wall surface portion comprises: pushing the distal end against a proximal portion of the inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion (Figs. 3-5 show the expandable distal end portion 32 of sheath shaft 18 is in an expanded state, thus pushing the balloon catheter 14 in a distal direction would have the condition of “pushing the distal end of the second distal portion against the inner wall surface portion comprises: pushing the distal end against a proximal portion of the inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion”); or pushing the distal end against a proximal end of the inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion (Figs. 4-5 show the expandable distal end portion 32 of sheath shaft 18 is in an expanded state, thus pushing the balloon catheter 14 in a distal direction would have the condition of “pushing the distal end against a proximal end of the inner wall surface portion defining the shaft delivery lumen extending through the expandable distal end portion”).
Referring to claim 18, the modified method of Martinez discloses the method claim 16, wherein advancing the introducer relative to the sheath shaft 18 comprises advancing the distal end of the second distal portion through a portion of the shaft delivery lumen proximal of the expandable distal end portion 32 (Figs. 3-4 show when the balloon catheter 14 is pushing forward the conical portion of the balloon 20 will move forward through the space between the distal end 32 of sheath shaft 18 and the conical portion of balloon 20).
Referring to claim 19, the modified method of Martinez discloses the method of claim 16, wherein advancing the introducer 14 relative to the sheath shaft 18 comprises advancing the distal end of the second distal portion to a position distal of a distal end of the sheath shaft 18 (Fig. 5) or to a position at a distal end of the sheath shaft (Fig. 4).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martinez et al. (US 5,453,090, hereinafter “Martinez”) in view of WO 2022/016059 (hereinafter “Neumann”).
Referring to claim 2, the modified device of Martinez discloses the system of claim 1 but fails to disclose wherein the externally oriented transition surface portion (distal end of balloon 20 as shown in Fig. 1, which is reproduced and annotated above) is perpendicular to the second externally oriented surface portion. However, in the same field of endeavor, which is a catheter balloon for dilating an expandable sheath and a blood vessel (“The introducer 160 includes an elongated body member 162 and one or more inflatable members, e.g., balloon(s) 164, disposed along the elongated body member 162 between proximal and distal ends 166, 168. The balloon 164 is configured to expand radially in a direction away from the outer surface of the elongated body member 162. As will be described in more detail below, when the balloon 164 is inflated, the distal end portion 140 of the sheath 100 expands providing an enlarged distal opening (FIG. 52).” ¶ [0206]), Neumann discloses the distal end portion of the balloon 164 can have many shapes, for example, conical shape similar to the distal end of Martinez balloon, or other shapes (Figs. 53A-53I), including perpendicular to the longitudinal axis of the catheter (Fig. 53D is reproduced below).
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Referring again to claim 2, in view of Neumann’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have shaped the distal end portion of the balloon 20 of Martinez to have a perpendicular surface as suggested by Neumann since Neumann discloses that a balloon with perpendicular surface perform similar to a balloon with a conical shape.
Claim(s) 11 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martinez et al. (US 5,453,090, hereinafter “Martinez”) in view of Mialhe (US 2007/0078504, hereinafter “Mialhe”).
Referring to claim 11, the modified device of Martinez discloses the system of claim 1, but fails to disclose further comprising a spacer member between a proximal end of the sheath hub and a distal end of an introducer hub, and wherein the spacer member comprises a mating portion, the mating portion having a recess extending through a longitudinal dimension, and the recess being configured to at least partially receive a corresponding portion of the introducer shaft.
Referring again to claim 11, however, in the same field of endeavor, which is a method of delivering an implant, Mialhe discloses the step of sliding a corresponding portion of the introducer shaft 14 out from a recess extending through a longitudinal dimension of a spacer members 8, 9 (Figs. 1-2 and 11-18) prior to advancing the introducer relative to the sheath shaft. Apparently, the advantage of providing spacer(s) is/are to prevent the surgeon accidentally deployed the implant before the delivery device is reached at a desired position. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a spacer, which is located between the proximal end of sheath 18 and distal end of the hub of the balloon catheter (i.e., the location at lead line 16 as shown in Fig. 1), to the system of Martinez so that it too would have the same advantage.
Referring to claim 20, the modified method of Martinez discloses the method of claim 16, but fails to disclose further comprising sliding a corresponding portion of the introducer shaft 14 out from a recess extending through a longitudinal dimension of a spacer member prior to advancing the introducer relative to the sheath shaft.
Referring again to claim 20, however, in the same field of endeavor, which is a method of delivering an implant, Mialhe discloses the step of sliding a corresponding portion of the introducer shaft 14 out from a recess extending through a longitudinal dimension of a spacer members 8, 9 (Figs. 1-2 and 11-18) prior to advancing the introducer relative to the sheath shaft. Apparently, the advantage of providing spacer(s) is/are to prevent the surgeon accidentally deployed the implant before the delivery device is reached at a desired position. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a spacer, which is located between the proximal end of sheath 18 and distal end of the hub of the balloon catheter (i.e., the location at lead line 16 as shown in Fig. 1), to the system of Martinez so that it too would have the same advantage.
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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