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
This Office action is in response to the applicant’s communication filed 08/20/2025.
Status of the claims:
Claims 1, 4, 6, 8 – 19, and 22 – 26 are pending in the application.
Claims 1, 11, 18, and 19 are amended.
Election/Restrictions
Newly submitted claims 25 and 26 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions of the originally filed claims and of claims 25 – 26 are related as product and process of use, respectively. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product such as for removing an object from the body.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 25 – 26 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Priority
The instant application, filed on 06/21/2023, is a continuation of US Application 17/096,730, filed on 11/12/2020, which claims priority to Provisional Application 62/934,410, filed on 11/12/2019. Claims 1 – 20 of the instant application are directed to subject matter that was introduced for the first time in US Application, filed on 11/12/2020. The earlier Provisional Application fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for a “first and second plurality of measurement indicia” as recited by independent claims 1 and 18. Accordingly, claims 1 and 18 are not entitled to the benefit of the prior Provisional Application because the terms “first plurality of measurement indicia” and “second plurality of measurement indicia”, recited in claims 1 and 18 of the Instant Application, are not disclosed within the Provisional Application. The earliest disclosure for the subject matter of claims 1 – 20 and, thus, the effective filing date for the subject matter of claims 1 – 20 is 11/12/2020.
Claim Objections
The objections to claims 18 and 22 in the previous action dated 10/21/2025 have been withdrawn in light of the Applicant’s amendments filed 03/20/2026. Specifically, the objection to claim 18 regarding the phrase “along second proximal portion”, and the objection to claim 23 regarding the phrase “a hub” have been withdrawn as the appropriate corrections have been made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 6, 8 – 11, 14 – 16, 18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Golden et al (US. 2009/0192518 A1) (previously cited), and in view of Andreas et al (US 2005/0149159 A1) (previously cited).
Regarding claims 1 and 24, Golden discloses a catheter system (catheter handle system 100 for delivering a stent) (abstract, paragraph [0057], and Figs. 1, 9 – 15, 18, and 30 – 37) (Examiner’s note: as stated in paragraphs [0027 – 0036] and [0049 – 0055] the catheter systems shown in Figs. 1, 9 – 15, 18, and 30 – 37 are the same catheter system embodiment), comprising:
a guide catheter (external member 160) (paragraphs [0057 – 0059] and Figs. 1, 9 – 15, and 18);
a delivery catheter (intermediate member 140) (paragraphs [0057 – 0059] and Figs. 1, 9 – 15, and 18) within a lumen of the guide catheter (Examiner’s note: as shown in Fig. 1 the intermediate member 140 extends through the lumen of the external member 160), wherein the delivery catheter (intermediate member 140) comprises a catheter hub (handle 150);
a pusher (inner member 120) (paragraphs [0057 – 0059] and Figs. 1, 9 – 15, and 18) with a proximal portion and a distal portion within a lumen of the delivery catheter (Examiner’s note: as shown in Fig. 1 the distal portion of the inner member 120 extends within the lumen of the intermediate member 140).
However, Golden is silent regarding (i) [claims 1 and 24] wherein the delivery catheter includes a first plurality of measurement indicia along a first proximal portion of the delivery catheter to illustrate movement of the delivery catheter relative to the guide catheter distal to the catheter hub, (ii) [claims 1 and 24] wherein the pusher includes a second plurality of measurement indicia along a second proximal portion of the pusher to illustrate movement of the pusher relative to the delivery catheter. With respect to the above, the Examiner notes Golden further states in paragraphs [0060], [0080 – 0084], wherein each tubular member 120, 140, and 160 are movable independent of each other; which means that the deployment catheter (intermediate member 140) is movable relative to the guide catheter (external member 160) and the pusher (inner member 120) is movable relative to the deployment catheter (intermediate member 140).
As to the above, Andreas teaches, in the same field of endeavor, a catheter system (delivery catheter 20) comprising a plurality of measurement indicia (indicia 60) associated with a delivery catheter (sheath) to show the movement of the deployment catheter (sheath 38) relative to a pusher (pusher 36) to indicate the amount of length the expandable member has been exposed (paragraphs [0063] and [0065], and Fig. 1).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the delivery catheter of Golden to incorporate the measurement indicia, based on the teachings of Andreas, for the purpose of allowing the operator to visually see the relative movement between the guide catheter (external member 160 – Golden) and the delivery catheter (intermediate member 140 – Golden), which provides visual feedback to the operator as to how much of the expandable member has been reloaded (“The external member 160 may be re-advanced over the stent 300 and the tubular band 220 to releasably and securely reset the position of the stent basket 200 and/or the intermediate member 140 relative to the position of the inner member 120, thereby reloading the stent” – discussed in paragraph [0080] – Golden). Furthermore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the pusher of Golden to incorporate the measurement indicia, based on the teachings of Andreas, to see the relative movement between the pusher (inner member 120 – Golden) and the delivery catheter (intermediate member 140 – Golden) (the external member 160 and the intermediate member 140 may be moved in concert while keeping the inner member 120 fixed or relatively fixed as discussed in paragraphs [0082] and [0084]), which provides visual feedback to the operator as to the relative location of the stent within the external member 160 as well as to the deployment of the stent.
It should be understood that the modification makes obvious such that the indicia 60, of Andreas, are applied to the outer surface of the proximal end of both the intermediate member 140 and the inner member 120 (i.e., the first and second proximal portions) (also shown in annotated Fig. 13 of Golden below), as this is where the operator would best be able to visualize the markings and the relative movement between shafts. Furthermore, it is noted that the first plurality of indicia are distal to the hub (handle 150 of Golden).
Annotated Fig. 13 of Golden
(modified in view of Andreas)
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Regarding claims 4, 6, 8, and 9, as stated above, it would be obvious to modify the delivery catheter and the pusher of Golden to incorporate the measurement indicia of Andreas on to both shafts. The combination further teaches [claims 4, 6, 8, and 9] wherein the first plurality of measurement indicia comprise a [first] plurality of lines oriented perpendicular to the length of the delivery catheter and wherein the second plurality of indicia comprise a [second] plurality of lines oriented perpendicular to the length of the pusher (Examiner’s note: for claims 4 – 9, as stated above, the modification is such that the measurement indicia 60 is incorporated onto both the delivery catheter (intermediate member 140) and the pusher (inner member 120); and as shown in Fig. 1 of Andreas the measurement indicia comprise a plurality of lines that are perpendicular to the length of the delivery system; therefore, the delivery catheter (intermediate member 140) and pusher (inner member 120) of Golden in view of Andreas encompass a first plurality of perpendicular lines (indicia on the intermediate member 140) and second plurality of perpendicular lines (indicia on the inner member 120)). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 10, as stated above, the combination of Golden in view of Andreas teaches the catheter system above. Additionally, Golden discloses further comprising a handle (handle 130 – Golden) (paragraph [0060] and Figs. 1, 9 – 15, and 18 – Golden) for adjusting the pusher (inner member 120 – Golden) with respect to the delivery catheter (Examiner’s note: as stated in paragraph [0060] the handle 130 is used to independently move / adjust the position of the inner member 120 – Golden).
Regarding claim 11, as stated above, the combination of Golden in view of Andreas teaches the catheter system above. Additionally, Golden teaches wherein the handle (handle 130 – Golden) is connected to the proximal portion of the pusher (Fig. 9 – Golden).
Regarding claim 14, as stated above, the combination of Golden in view of Andreas teaches the catheter system above. Additionally, Golden discloses further comprising a handle (combination of handle 130 and handle 150 when locked together – Golden) for moving the pusher and the delivery catheter (Examiner’s note: as stated in paragraphs [0060 – 0061] and [0065] the proximal handle 130 connects to the intermediate handle 150, forming a singular handle, and the proximal handle 130 controls the movement of the inner member 120 (i.e., the pusher) and the handle 150 controls the movement of the intermediate member 140 (i.e., the delivery catheter), thus, when the handles are combined to the singular handle, the singular handle would move both the inner member 120 (i.e., the pusher) and the intermediate member 140 (i.e., the delivery catheter) – Golden).
Regarding claim 15, as stated above, the combination of Golden in view of Andreas teaches the catheter system above. Additionally, Golden teaches wherein the handle (combination of handle 130 and handle 150 when locked together – Golden) includes a tube (handle 130 – Golden) that is positioned around the pusher (Examiner’s note: a tube is defined as a long hollow cylinder; and as shown in Fig. 10 the handle 130 is a long hollow cylinder that is positioned around the inner member 120 (i.e., the pusher)).
Regarding claim 16, as stated above, the combination of Golden in view of Andreas teaches the catheter system above. Additionally, Golden teaches wherein the tube (handle 130 – Golden) is connected to a proximal end of the delivery catheter (Examiner’s note: as shown in Fig. 10 the handle 130 is connected to the proximal end of the intermediate member 140 via the handle 150).
Regarding claim 18, Golden discloses a catheter system (catheter handle system 100 for delivering a stent) (abstract, paragraph [0057], and Figs. 1, 9 – 15, 18, and 30 – 37) (Examiner’s note: as stated in paragraphs [0027 – 0036] and [0049 – 0055] the catheter systems shown in Figs. 1, 9 – 15, 18, and 30 – 37 are the same catheter system embodiment), comprising:
a guide catheter (external member 160) (paragraphs [0057 – 0059] and Figs. 1, 9 – 15, and 18);
a delivery catheter (intermediate member 140) (paragraphs [0057 – 0059] and Figs. 1, 9 – 15, and 18) within a lumen of the guide catheter (Examiner’s note: as shown in Fig. 1 the intermediate member 140 extends through the lumen of the external member 160);
a pusher (inner member 120) (paragraphs [0057 – 0059] and Figs. 1, 9 – 15, and 18) within a lumen of the delivery catheter (Examiner’s note: as shown in Fig. 1 the inner member 120 extends within the lumen of the intermediate member 140);
a single, unitary handle (combination of handle 130 and handle 150 when locked together) (paragraphs [0061], [0065], and Figs. 1, 9 – 15, and 18) including a tube (handle 150, which is in the form of a tube) that is positioned around the pusher and connected to a proximal end of the delivery catheter for both distally pushing the pusher and proximally retracting the delivery catheter (Examiner’s note: as stated in paragraphs [0060 – 0061] and [0065] the proximal handle 130 connects to the intermediate handle 150, forming a singular united handle, and the proximal handle 130 controls the movement of the inner member 120 (i.e., the pusher) and the handle 150 controls the movement of the intermediate member 140 (i.e., the delivery catheter), thus, when the handles are combined to the singular handle, the singular handle would distally push and proximally retract the inner member 120 (i.e., the pusher) and the intermediate member 140 (i.e., the delivery catheter), respectively).
However, Golden is silent regarding (i) wherein the delivery catheter includes a first plurality of measurement indicia along a first proximal portion of the delivery catheter to illustrate movement of the delivery catheter relative to the guide catheter; and (ii) wherein the pusher includes a second plurality of measurement indicia along a second proximal portion of the pusher to illustrate movement of the pusher relative to the delivery catheter. With respect to the above, the Examiner notes Golden further states in paragraph [0060] wherein each tubular member 120, 140, and 160 are movable independent of each other; which means that the deployment catheter (intermediate member 140) is movable relative to the guide catheter (external member 160) and the pusher (inner member 120) is movable relative to the deployment catheter (intermediate member 140).
As to the above, Andreas teaches, in the same field of endeavor, a catheter system (delivery catheter 20) comprising a plurality of measurement indicia (indicia 60) associated with a delivery catheter (sheath) to show the movement of the deployment catheter (sheath 38) relative to a pusher (pusher 36) to indicate the amount of length the expandable member has been exposed (paragraphs [0063] and [0065], and Fig. 1).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the delivery catheter of Golden to incorporate the measurement indicia, based on the teachings of Andreas, for the purpose of allowing the operator to visually see the relative movement between the guide catheter (external member 160 – Golden) and the delivery catheter (intermediate member 140 – Golden), which provides visual feedback to the operator as to how much of the expandable member has been reloaded (“The external member 160 may be re-advanced over the stent 300 and the tubular band 220 to releasably and securely reset the position of the stent basket 200 and/or the intermediate member 140 relative to the position of the inner member 120, thereby reloading the stent” – discussed in paragraph [0080] – Golden). Furthermore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the pusher of Golden to incorporate the measurement indicia, based on the teachings of Andreas, to see the relative movement between the pusher (inner member 120 – Golden) and the delivery catheter (intermediate member 140 – Golden) (the external member 160 and the intermediate member 140 may be moved in concert while keeping the inner member 120 fixed or relatively fixed as discussed in paragraphs [0082] and [0084]), which provides visual feedback to the operator as to the relative location of the stent within the external member 160 as well as to the deployment of the stent.
It should be understood that the modification above is such that the indicia 60, of Andreas, is applied to the outer surface of the proximal end of both the intermediate member 140 and the inner member 120 (i.e., the first and second proximal portions) (also shown in annotated Fig. 13 of Golden below), as this is where the operator would best be able to visualize the markings and the relative movement between shafts.
Annotated Fig. 13 of Golden
(modified in view of Andreas)
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Claims 12, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Golden et al (US. 2009/0192518 A1) (previously cited) in view of Andreas et al (US 2005/0149159 A1) (previously cited), as applied to claims 10 and 18 above, and further in view of Majercak et al (US 2018/0250150 A1) (previously cited).
Regarding claims 12, 13, and 19, as discussed above, the combination of Golden and Andreas teaches the catheter system of claim 10 and 18.
However, the combination of Golden and Andreas is silent regarding [claims 12 and 19] wherein the handle includes a thumbwheel and [claim 13] wherein the thumb wheel includes a plurality of rotational detents that indicate movement of the pusher a specific distance.
As to the above, Majercak teaches, in the same field of endeavor, catheter system (prosthesis delivery system 10) comprising a catheter (outer sheath 30) with a handle (handle 200; which is equated to the handle 130 of Golden) which comprises a thumbwheel (rotatable actuator 210) which includes a plurality of rotational detents that indicate movement of the pusher a specific distance (Examiner’s note: as stated in paragraph [0045] the actuator 210 / and handle 200 are used with the catheter system 10; furthermore, as shown in Fig. 7, the thumbwheel comprises a plurality of rotational detents (indents). Moreover, the operator can count the number of the detents / indents of the thumbwheel as they pass a reference point on the handle, and based on the number of detents / indents pass the reference point, the operator will have an indication as to the amount of rotation of the thumbwheel which translates to the amount of retraction or extension of the actuated shaft / sheath / tube; therefore, the plurality of detents provides an indication to the movement of the shaft / sheath / tube being actuated a specific distance).
It should be understood that the both Golden and Majercak are both references in the art that teach a stent delivery system comprising the relative movement between shafts (abstract and paragraph [0060] – Golden ; abstract and paragraph [0045] – Majercak); and the examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one means of actuating the movement of a shaft (i.e. the slider handle 130 attached to the inner member 120 of Golden) with another means of actuating the movement of a shaft (handle 200 and rotatable wheel actuator 210 of Majercak), and the results of the substitution would have been predictable and resulted in the modified handle of Golden being able to function as intended to properly adjust / move the inner member 120 relative to the intermediate and external members. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Furthermore, it is noted that the modification made above is such that the handle 130 of Golden is replaced with the handle and rotatable wheel 210 of Majercak; and the rotatable wheel 210 of Majercak comprises the plurality of detents that indicate movement of the pusher a specific distance, as detailed above. Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Golden et al (US. 2009/0192518 A1) (previously cited) in view of Andreas et al (US 2005/0149159 A1) (previously cited), as applied to claim 1 above, and further in view of Andreas et al (US 2005/0222603 A1) (herein referred to as Andreas ‘603).
Regarding claim 22, as discussed above, the combination of Golden and Andreas teaches the catheter system of claim 1.
However, the current combination of Golden and Andreas is silent regarding (i) wherein the guide catheter comprises a hemostatic valve, and wherein an edge of the hemostatic valve is operable to align with and identify a first measurement indicia of the first plurality of measurement indicia.
As to the above, Andreas ‘603 teaches, in the same field of endeavor, a catheter system (delivery catheter 20) and wherein a hemostatic seal 106 is mounted within a collar 26 (which is equates to the guide catheter (i.e., the elongated tubular external member 160) and handle 170 of Golden) between the inner surface of the collar 26 and the exterior of the catheter body 12 (which is equates to the delivery catheter (i.e., the intermediate member 140) of Golden) in order to minimize leakage of blood through channel 104 of the collar 26 (which equates to the lumen through the guide catheter (i.e., the elongated tubular external member 160) / handle 170 of Golden) (paragraph [0047] and Fig. 5).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the handle 170 of Golden to incorporate a hemostatic valve between the inner surface of the handle 170 and the exterior surface of the intermediate member 140 (i.e., the delivery catheter), based on the teachings of Andreas ‘603, for the purpose of minimizing the leakage of blood through the handle 170 at the proximal end. Furthermore, it would be obvious for the hemostatic valve to be placed at the proximal end of the handle 170 as there are a finite number of locations to place the hemostatic valve within the handle 170, and it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). Additionally, as the hemostatic valve is at the proximal most end of the handle 170, the edge (i.e., the perimeter of the proximal most face) of the hemostatic valve will align with indicia of the first plurality of indica on the delivery catheter (i.e., the intermediate member 140) as the delivery catheter passes through and the operator is able to identify said indicia by means of the edge of the hemostatic.
Regarding claim 23, as discussed above, the combination of Golden, Andreas, and Andreas ‘603 teaches the catheter system of claim 1. Additionally, Golden teaches the catheter hub (handle 150) having an edge (perimeter of the proximal most face of the handle 150) operable to align with and identify an indicia of the second plurality of indicia on the pusher (inner member 120) (Examiner’s note: as shown in Figs. 9 and 13 – 14, the perimeter of the proximal most face of the handle 150 (i.e., the edge) aligns with and identifies the point at which the inner member 120 (i.e., the pusher) enters the handle 150 (i.e., the hub), and that point would align and identify an indicia of the second plurality of indica as inner member 120 (i.e., the pusher) passes through the handle 150 (i.e., the hub)).
Claims 1, 4, 6, 8 – 11, 14 – 17, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Golden et al (US. 2009/0192518 A1) (previously cited), and in view of Andreas et al (US 2005/0149159 A1) (previously cited) and Dorn et al (US 2014/0107757 A1) (previously cited).
Regarding claims 1 and 24, (alternate interpretation) Golden discloses a catheter system (catheter handle system 100 for delivering a stent) (abstract, paragraph [0057], and Figs. 1, 9 – 15, 18, and 30 – 37) (Examiner’s note: as stated in paragraphs [0027 – 0036] and [0049 – 0055] the catheter systems shown in Figs. 1, 9 – 15, 18, and 30 – 37 are the same catheter system embodiment), comprising:
a guide catheter (external member 160) (paragraphs [0057 – 0059] and Figs. 1, 9 – 15, and 18);
a delivery catheter (intermediate member 140) (paragraphs [0057 – 0059] and Figs. 1, 9 – 15, and 18) within a lumen of the guide catheter (Examiner’s note: as shown in Fig. 1 the intermediate member 140 extends through the lumen of the external member 160),
a pusher (inner member 120) (paragraphs [0057 – 0059] and Figs. 1, 9 – 15, and 18) with a proximal portion and a distal portion within a lumen of the delivery catheter (Examiner’s note: as shown in Fig. 1 the distal portion of the inner member 120 extends within the lumen of the intermediate member 140).
However, Golden is silent regarding (i) [claim 1] a catheter hub, (ii) [claims 1 and 24] wherein the delivery catheter includes a first plurality of measurement indicia along a first proximal portion of the delivery catheter to illustrate movement of the delivery catheter relative to the guide catheter distal to the catheter hub, and (iii) [claim 1] [claims 1 and 24] wherein the pusher includes a second plurality of measurement indicia along a second proximal portion of the pusher to illustrate movement of the pusher relative to the delivery catheter. With respect to (ii) – (iii), the Examiner notes Golden further states in paragraph [0060] wherein each tubular member 120, 140, and 160 are movable independent of each other; which means that the deployment catheter (intermediate member 140) is movable relative to the guide catheter (external member 160) and the pusher (inner member 120) is movable relative to the deployment catheter (intermediate member 140).
As to (i), Dorn teaches, in the same field of endeavor, a catheter delivery system comprising a delivery catheter (outer shaft 26) with a handle (hub 30) and a catheter hub (spacer 70), and a pusher (shaft 54) within the delivery catheter (paragraphs [0028 – 0033] and Figs. 3A – 3C). Dorn, in paragraph [0032], wherein the hub (spacer 70) helps to maintain the gap between the two handles of the two shafts prior to the delivery of the stent.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Golden to include a hub (i.e., a spacer) between the two handles / on the catheter, as taught by Dorn, for the purpose of maintaining the gap between the handles prior to the delivery of the stent, which prevents the stent from being pre-deployed.
As to (ii) and (iii), Andreas teaches, in the same field of endeavor, a catheter system (delivery catheter 20) comprising a plurality of measurement indicia (indicia 60) associated with a delivery catheter (sheath) to show the movement of the deployment catheter (sheath 38) relative to a pusher (pusher 36) to indicate the amount of length the expandable member has been exposed (paragraphs [0063] and [0065], and Fig. 1).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the delivery catheter of Golden to incorporate the measurement indicia, based on the teachings of Andreas, for the purpose of allowing the operator to visually see the relative movement between the guide catheter (external member 160 – Golden) and the delivery catheter (intermediate member 140 – Golden), which provides visual feedback to the operator as to how much of the expandable member has been reloaded (“The external member 160 may be re-advanced over the stent 300 and the tubular band 220 to releasably and securely reset the position of the stent basket 200 and/or the intermediate member 140 relative to the position of the inner member 120, thereby reloading the stent” – discussed in paragraph [0080] – Golden). Furthermore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the pusher of Golden to incorporate the measurement indicia, based on the teachings of Andreas, to see the relative movement between the pusher (inner member 120 – Golden) and the delivery catheter (intermediate member 140 – Golden) (the external member 160 and the intermediate member 140 may be moved in concert while keeping the inner member 120 fixed or relatively fixed as discussed in paragraphs [0082] and [0084]), which provides visual feedback to the operator as to the relative location of the stent within the external member 160 as well as to the deployment of the stent.
It should be understood that the modification makes obvious such that the indicia 60, of Andreas, are applied to the outer surface of the proximal end of both the intermediate member 140 and the inner member 120 (i.e., the first and second proximal portions) (also shown in annotated Fig. 13 of Golden below), as this is where the operator would best be able to visualize the markings and the relative movement between shafts. Furthermore, it is noted that the first plurality of indicia are distal to the hub (handle 150 of Golden).
Annotated Fig. 13 of Golden
(modified in view of Andreas)
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Regarding claims 4, 6, 8, and 9, as stated above, it would be obvious to modify the delivery catheter and the pusher of Golden, under the alternate interpretation, in view of Dorn to incorporate the measurement indicia of Andreas on to both shafts. The combination further teaches [claims 4, 6, 8, and 9] wherein the first plurality of measurement indicia comprise a [first] plurality of lines oriented perpendicular to the length of the delivery catheter and wherein the second plurality of indicia comprise a [second] plurality of lines oriented perpendicular to the length of the pusher (Examiner’s note: for claims 4 – 9, as stated above, the modification is such that the measurement indicia 60 is incorporated onto both the delivery catheter (intermediate member 140) and the pusher (inner member 120); and as shown in Fig. 1 of Andreas the measurement indicia comprise a plurality of lines that are perpendicular to the length of the delivery system; therefore, the delivery catheter (intermediate member 140) and pusher (inner member 120) of Golden in view of Andreas encompass a first plurality of perpendicular lines (indicia on the intermediate member 140) and second plurality of perpendicular lines (indicia on the inner member 120)). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 10, as stated above, the combination of Golden, under the alternate interpretation, in view of Andreas and Dorn teaches the catheter system above. Additionally, Golden teaches further comprising a handle (handle 130 – Golden) (paragraph [0060] and Figs. 1, 9 – 15, and 18 – Golden) for adjusting the pusher (inner member 120 – Golden) with respect to the delivery catheter (Examiner’s note: as stated in paragraph [0060] the handle 130 is used to independently move / adjust the position of the inner member 120 – Golden).
Regarding claim 11, as stated above, the combination of Golden, under the alternate interpretation, in view of Andreas and Dorn teaches the catheter system above. Additionally, Golden teaches wherein the handle (handle 130 – Golden) is connected to a proximal portion of the pusher (Examiner’s note: as shown in Fig. 9 the handle 130 is attached to the proximal end of the pusher / inner member 120 – Golden).
Regarding claim 14, as stated above, the combination of Golden, under the alternate interpretation, in view of Andreas and Dorn teaches the catheter system above. Additionally, Golden teaches further comprising a handle (handle 130 – Golden) for moving the pusher and the delivery catheter (Examiner’s note: the handle 130 can be used for moving the entire system at the same time which includes the pusher and the delivery catheter).
Regarding claim 15, as stated above, the combination of Golden, under the alternate interpretation, in view of Andreas and Dorn teaches the catheter system above. Additionally, Golden teaches wherein the handle (handle 130 – Golden) includes a tube (handle 130 – Golden) that is positioned around the pusher (Examiner’s note: a tube is defined as a long hollow cylinder; and as shown in Fig. 10 the handle 130 is a long hollow cylinder that is positioned around the pusher / inner member 120; therefore, Golden encompasses the limitation above).
Regarding claim 16, as stated above, the combination of Golden, under the alternate interpretation, in view of Andreas and Dorn teaches the catheter system above. Additionally, Golden teaches wherein the tube (handle 130 – Golden) is connected to a proximal end of the delivery catheter (Examiner’s note: as shown in Fig. 10 the handle 130 is connected to the proximal end of the intermediate member 140 via the handle 150).
Regarding claim 17, as stated above, the combination of Golden, under the alternate interpretation, in view of Andreas and Dorn teaches the catheter system above. Additionally, Golden teaches further comprising a first handle (handle 130 – Golden) for moving the pusher (inner member 120 – Golden) and a second handle (handle 150 – Golden) for moving the delivery catheter (intermediate member 140 – Golden) (paragraph [0060] and Figs. 1, 9 – 15, and 18 – Golden) (Examiner’s note: as stated in paragraph [0060] the handle 130 is used to independently move / adjust the position of the inner member 120; and as stated in paragraph [0060] the handle 150 is used to independently move / adjust the position of the intermediate member 140 – Golden).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Golden et al (US. 2009/0192518 A1) (previously cited) in view of Andreas et al (US 2005/0149159 A1) (previously cited) and Dorn et al (US 2014/0107757 A1), as applied to claim 10 above, and further in view of Majercak et al (US 2018/0250150 A1) (previously cited).
Regarding claims 12 and 13, as stated above, the combination of (alternate interpretation) Golden, Andreas, and Dorn teaches the catheter system of claim 10.
However, the combination of (alternate interpretation) Golden, Andreas, and Dorn is silent regarding [claim 12] wherein the handle includes a thumbwheel and [claim 13] wherein the thumb wheel includes a plurality of rotational detents that indicate movement of the pusher a specific distance.
As to the above, Majercak teaches, in the same field of endeavor, catheter system (prosthesis delivery system 10) comprising a catheter (outer sheath 30) with a handle (handle 200; which is equated to the handle 130 of Golden) which comprises a thumbwheel (rotatable actuator 210) which includes a plurality of rotational detents that indicate movement of the pusher a specific distance (Examiner’s note: as stated in paragraph [0045] the actuator 210 / and handle 200 are used with the catheter system 10; furthermore, as shown in Fig. 7, the thumbwheel comprises a plurality of rotational detents (indents). Moreover, the operator can count the number of the detents / indents of the thumbwheel as they pass a reference point on the handle, and based on the number of detents / indents pass the reference point, the operator will have an indication as to the amount of rotation of the thumbwheel which translates to the amount of retraction or extension of the actuated shaft / sheath / tube; therefore, the plurality of detents provides an indication to the movement of the shaft / sheath / tube being actuated a specific distance).
It should be understood that the both Golden and Majercak are both references in the art that teach a stent delivery system comprising the relative movement between shafts (abstract and paragraph [0060] – Golden ; abstract and paragraph [0045] – Majercak); and the examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one means of actuating the movement of a shaft (i.e. the slider handle 130 attached to the inner member 120 of Golden) with another means of actuating the movement of a shaft (handle 200 and rotatable wheel actuator 210 of Majercak), and the results of the substitution would have been predictable and resulted in the modified handle of Golden being able to function as intended to properly adjust / move the inner member 120 relative to the intermediate and external members. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Furthermore, it is noted that the modification made above is such that the handle 130 of Golden is replaced with the handle and rotatable wheel 210 of Majercak; and the rotatable wheel 210 of Majercak comprises the plurality of detents that indicate movement of the pusher a specific distance, as detailed above. Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Golden et al (US. 2009/0192518 A1) (previously cited) in view of Andreas et al (US 2005/0149159 A1) (previously cited) and Dorn et al (US 2014/0107757 A1), as applied to 1 above, and further in view of Andreas et al (US 2005/0222603 A1) (herein referred to as Andreas ‘603).
Regarding claim 22, as discussed above, the combination of (alternate interpretation) Golden, Andreas, and Dorn teaches the catheter system of claim 1.
However, the current combination of (alternate interpretation) Golden, Andreas, and Dorn is silent regarding (i) wherein the guide catheter comprises a hemostatic valve, and wherein an edge of the hemostatic valve is operable to align with and identify a first measurement indicia of the first plurality of measurement indicia.
As to the above, Andreas ‘603 teaches, in the same field of endeavor, a catheter system (delivery catheter 20) and wherein a hemostatic seal 106 is mounted within a collar 26 (which is equates to the guide catheter (i.e., the elongated tubular external member 160) and handle 170 of Golden) between the inner surface of the collar 26 and the exterior of the catheter body 12 (which is equates to the delivery catheter (i.e., the intermediate member 140) of Golden) in order to minimize leakage of blood through channel 104 of the collar 26 (which equates to the lumen through the guide catheter (i.e., the elongated tubular external member 160) / handle 170 of Golden) (paragraph [0047] and Fig. 5).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the handle 170 of Golden, under the alternate interpretation, to incorporate a hemostatic valve between the inner surface of the handle 170 and the exterior surface of the intermediate member 140 (i.e., the delivery catheter), based on the teachings of Andreas ‘603, for the purpose of minimizing the leakage of blood through the handle 170 at the proximal end. Furthermore, it would be obvious for the hemostatic valve to be placed at the proximal end of the handle 170 as there are a finite number of locations to place the hemostatic valve within the handle 170, and it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). Additionally, as the hemostatic valve is at the proximal most end of the handle 170, the edge (i.e., the perimeter of the proximal most face) of the hemostatic valve will align with indicia of the first plurality of indica on the delivery catheter (i.e., the intermediate member 140) as the delivery catheter passes through and the operator is able to identify said indicia by means of the edge of the hemostatic.
Regarding claim 23, as discussed above, the combination of (alternate interpretation) Golden, Andreas, and Andreas ‘603 teaches the catheter system of claim 1. Additionally, Golden teaches the hub (handle 150) having an edge (perimeter of the proximal most face of the handle 150) operable to align with and identify an indicia of the second plurality of indicia on the pusher (inner member 120) (Examiner’s note: as shown in Figs. 9 and 13 – 14, the perimeter of the proximal most face of the handle 150 (i.e., the edge) aligns with and identifies the point at which the inner member 120 (i.e., the pusher) enters the handle 150 (i.e., the hub), and that point would align and identify an indicia of the second plurality of indica as inner member 120 (i.e., the pusher) passes through the handle 150 (i.e., the hub)).
Response to Arguments
Applicant's arguments filed 03/20/2026 with respect to the newly added claims 25 and 26, directed to a method (e.g., an unelected invention). The Examiner notes that the claims are hereby withdrawn as they are directed to an unelected invention, since claims 1 and 18 have been constructively elected by original presentation for prosecution on the merits. Therefore, the arguments directed to claims 25 and 26 are moot.
Applicant's arguments filed 03/20/2026, with respect to the rejection of claims 1 and 18 under Golden and Andreas, and under Golden, Andreas, and Dorn have been fully considered but they are not persuasive. More specifically:
Regarding Applicant’s argument that “Andreas does not disclose pair of concentric tubular members each having their own indicia”, it should be understood that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, even though Andreas lacks the measurement indicia on the claimed location and multiple concentric tubular members each with their own indicia, Andreas still teaches it is obvious to have measurement indicia on a tubular member that move relative to another tubular member for the purpose of being able to see the amount of relative movement of either one of the tubular members (paragraphs [0063] and [0065] – Andreas); and therefore, based off the teachings of Andreas, it is obvious to apply measurement indicia to both concentric tubular members of Golden which move relative to each other in order to see the relative amount of movement between the movable shafts.
With respect to Applicant’s argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning (“Applicant respectfully disagrees, as this argument appears to rely on impermissible hindsight. There is no disclosure within any of the cited references that discloses, teaches, or even suggests the use of indicia on both a pusher and a delivery catheter as claimed herein”), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 04/23/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
Contact Information
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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