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 03/29/2026.
Status of the claims:
Claims 1 – 22 are pending in the application.
Claims 1, 11, and 17 are amended.
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, 7-14, 17-19, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 6,159,225) (previously cited) in view of Belson (US 2012/0197200 A1) (previously cited as the WO version).
Regarding claims 1 – 4, 7, and 10, Makower discloses a re-entry device (catheter system) for recanalization of a vessel including a wall using a subintimal technique (abstract, col. 2 line 39 – col. 3 line 10, col. 8 lines 27 – 40, and Fig. 14), comprising:
a catheter (guide catheter 146) having a first inner lumen (lumen through which needle 141 extends – Fig. 14) extending to a distal end portion of the catheter (col. 8 lines 27 – 45 and Fig. 14), the distal end portion (portion distal to the balloon 144 / distal tip 145) including an angled tip (portion distal to balloon 144 / distal tip 145) having a distal open end (Fig. 14) (Examiner’s note: although Makower is silent regarding wherein the needle 141 extends through a lumen from the proximal end to the distal end, such that the needle 141 is retractable within the lumen; it would be obvious and well within the purview of one of ordinary skill in the art for the designated lumen to be a lumen, and for that lumen to house the needle 141 in a retracted state for the purpose of covering the needle while the catheter is being delivered to the treatment site in order to protect the needle and vasculature walls from unintended damage. Therefore, Makower makes obvious wherein the designated lumen is a lumen);
[claim 10] wherein the angled tip forms an acute angle relative to a longitudinal axis of the catheter (guide catheter 146) (Fig. 14);
an elongated stylet (needle 141) located in the first inner lumen (lumen through which needle 141 extends – Fig. 14) (see Examiner’s note above) projecting from the distal open end of the angled tip (distal tip 145) for penetrating the wall of the vessel (Fig. 14), the stylet (needle 141) having an angled distal end portion forming a needle (needle 141) (col. 8 lines 27 – 45 and Fig. 14) (Examiner’s note: the distal end portion of the needle 141 angled relative to the portion of the guide catheter 146 that is proximal of distal tip 145 portion); and
[claim 2] wherein the catheter (guide catheter 146) includes a second inner lumen (working channel 143) for a guidewire (Examiner’s note: the working channel 143 is capable of being used for a guidewire);
[claim 7] wherein the needle (needle 143) is solid (Examiner’s note: the needle is a solid structure);
[claim 21] wherein the angled tip (portion distal to balloon 144 / distal tip 145) includes a portion of the first inner lumen (lumen through which the needle 141 extends through) extending at an angle relative to an upstream portion of the first inner lumen (Fig. 14);
[claim 22] wherein the angled distal end portion of the stylet is bent relative to an upstream portion of the stylet (Fig. 14) (Examiner’s note: the distal end portion of the needle 141 (i.e., the portion of the stylet shown in Fig. 14) is bent relative to the portion of the needle 141 that is within the curved portion of the distal tip 145 (i.e., an upstream portion)).
However, Makower is silent regarding [claim 1] (i) an actuator at a proximal end portion of the catheter for advancing the stylet from a retracted position within the catheter to a deployed position projecting from the distal open end of the angled tip for penetrating the wall of the vessel, (ii) wherein the actuator comprises a predetermined stroke distance directly proportional to an ejection distance of the distal end portion of the stylet, [claim 3] wherein the actuator is located on a hub of the catheter, and [claim 4] (iv) wherein the actuator comprises a slide.
As to the above, Belson teaches a venous access catheter comprising a hub (housing 21) with a sliding actuator (slider 3) thereon and at a proximal end portion of a catheter (catheter 102 and needle 7; which equates to the guide catheter 146 of Makower) for advancing a working device (guidewire 9; which equates to the needle 141 of Makower) from a retracted position (position shown in Fig. 3) within the catheter to a deployed position (position shown in Fig. 4), wherein the actuator (slider 3) comprises a predetermined stroke distance directly proportional to an ejection distance of the distal end portion of the stylet (abstract, paragraphs [0023 – 0026], [0035], and Figs. 1 – 4) (Examiner’s note: as shown in the transition between Figs. 3 and 4, the movement of the slider is directly related and proportional to the distal that the guidewire 9 (i.e., the stylet) is ejected from the distal end; additionally, as stated in paragraph [0025] the guidewire 9 (i.e., the stylet) is directly bonded to the tongue of the slider 3 (i.e., the actuator), and because there is no mention of any intervening structure, any movement of the slider (i.e., the actuator) will result in a 1 to 1 movement of the guidewire 9 (i.e., the stylet). Lastly, the distance traveled by the slider is determined prior to the traveling of the slider; therefore, the distance is pre-determined).
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 Makower to incorporate a hub and slider actuator, based the teachings of Belson, for the purpose of being able to retract and extend the stylet in and out of the lumen when needed.
Regarding claims 8 and 9, as discussed above, the combination of Makower and Belson teaches the device of claim 1.
However, the combination is silent regarding (i) [claim 8] wherein a diameter of the catheter is less than or equal to 4 French and/or (ii) [claim 9] wherein a diameter of the catheter is less than or equal to 1.33 millimeters.
As to the above, there is no evidence of record that establishes that changing the size / diameter of the guide catheter 146 of Makower would result in a difference in function of the device of Makower. Further, a person having ordinary skill in the art, being faced with modifying the guide catheter 146 of Makower, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed size / diameter. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the size / diameter “may” be within the claimed range (e.g., specification at para. [0006]) and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guide catheter 146 of Makower to have a size / diameter within the claimed ranges as an obvious matter of design choice within the skill of the art.
Regarding claims 11 – 14, Makower discloses a re-entry device for recanalization of a vessel including a wall using a subintimal technique (abstract, col. 2 line 39 – col. 3 line 10, col. 8 lines 27 – 40, and Fig. 14), comprising:
an elongated stylet (needle 141) having an angled distal end portion (distal end portion is angled relative to the guide catheter 146 – Fig. 14) including a needle (needle 141) to facilitate penetration of the wall of the vessel (col. 8 lines 27 – 40 and Fig. 14); and
a catheter (guide catheter 146) having a first inner lumen (lumen through which needle 141 extends – Fig. 14) in which the elongated stylet (needle 141) is located (col. 8 lines 27 – 45 and Fig. 14), [claim 12] a distal end portion (portion distal to balloon 144 / distal tip 145) of the catheter an angled tip having a distal open end (Fig. 14) (Examiner’s note: although Makower is silent regarding wherein the needle 141 extends through a lumen from the proximal end to the distal end, such that the needle 141 is retractable within the lumen; it would be obvious and well within the purview of one of ordinary skill in the art for the designated lumen to be a lumen, and for that lumen to house the needle 141 in a retracted state for the purpose of covering the needle while the catheter is being delivered to the treatment site in order to protect the needle and vasculature walls from unintended damage. Therefore, Makower makes obvious wherein the designated lumen is a lumen), and
a second inner lumen (working channel 143) for a guidewire (Examiner’s note: the working channel 143 is capable of being used for a guidewire);
[claims 13 and 14] wherein a distal end portion (portion distal to balloon 144 / distal tip 145) of the catheter is steerable from a control (coil 147) comprising a wire (coil 147) (col. 8 lines 30 – 40 and Fig. 14).
However, Makower is silent regarding (i) an actuator at a proximal end portion of the catheter for advancing the stylet from a retracted position within the catheter to a deployed position projecting from the distal open end of the angled tip for penetrating the wall of the vessel and (ii) wherein the actuator comprises a predetermined stroke distance directly proportional to an ejection distance of the distal end portion of the stylet.
As to the above, Belson teaches a venous access catheter comprising a hub (housing 21) with a sliding actuator (slider 3) thereon and at a proximal end portion of a catheter (catheter 102 and needle 7; which equates to the guide catheter 146 of Makower) for advancing a working device (guidewire 9; which equates to the needle 141 of Makower) from a retracted position (position shown in Fig. 3) within the catheter to a deployed position (position shown in Fig. 4), wherein the actuator (slider 3) comprises a predetermined stroke distance directly proportional to an ejection distance of the distal end portion of the stylet (abstract, paragraphs [0023 – 0026], [0035], and Figs. 1 – 4) (Examiner’s note: as shown in the transition between Figs. 3 and 4, the movement of the slider is directly related and proportional to the distal that the guidewire 9 (i.e., the stylet) is ejected from the distal end; additionally, as stated in paragraph [0025] the guidewire 9 (i.e., the stylet) is directly bonded to the tongue of the slider 3 (i.e., the actuator), and because there is no mention of any intervening structure, any movement of the slider (i.e., the actuator) will result in a 1 to 1 movement of the guidewire 9 (i.e., the stylet). Lastly, the distance traveled by the slider is determined prior to the traveling of the slider; therefore, the distance is pre-determined).
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 Makower to incorporate a hub and slider actuator, based the teachings of Belson, for the purpose of being able to retract and extend the stylet in and out of the lumen when needed.
Regarding claims 17, 18, and 19, Makower discloses a re-entry device for recanalization of a vessel including a wall using a subintimal technique (abstract, col. 2 line 39 – col. 3 line 10, col. 8 lines 27 – 40, and Fig. 14), comprising:
an elongated stylet (needle 141) having an angled distal end portion (distal end portion is angled relative to the guide catheter 146 – Fig. 14) including a [claim 19] solid needle (needle 141) to facilitate penetration of the wall of the vessel (col. 8 lines 27 – 40 and Fig. 14); and
a catheter (guide catheter 146) having a first inner lumen (lumen through which needle 141 extends – Fig. 14) in which the elongated stylet (needle 141) is located (col. 8 lines 27 – 45 and Fig. 14), a distal end portion (distal tip 145) of the catheter an angled tip having a distal open end (Fig. 14) (Examiner’s note: although Makower is silent regarding wherein the needle 141 extends through a lumen from the proximal end to the distal end, such that the needle 141 is retractable within the lumen; it would be obvious and well within the purview of one of ordinary skill in the art for the designated lumen to be a lumen, and for that lumen to house the needle 141 in a retracted state for the purpose of covering the needle while the catheter is being delivered to the treatment site in order to protect the needle and vasculature walls from unintended damage. Therefore, Makower makes obvious wherein the designated lumen is a lumen); and
[claim 18] a second inner lumen (working channel 143) for a guidewire (Examiner’s note: the working channel 143 is capable of being used for a guidewire).
However, Makower is silent regarding (i) an actuator at a proximal end portion of the catheter for advancing the stylet from a retracted position within the catheter to a deployed position projecting from the distal open end of the angled tip for penetrating the wall of the vessel, (ii) wherein the actuator comprises a predetermined stroke distance directly proportional to an ejection distance of the distal end portion of the stylet, and (iii) the catheter having a diameter of less than or equal to 1.33 mm.
As to (i) – (ii), Belson teaches a venous access catheter comprising a hub (housing 21) with a sliding actuator (slider 3) thereon and at a proximal end portion of a catheter (catheter 102 and needle 7; which equates to the guide catheter 146 of Makower) for advancing a working device (guidewire 9; which equates to the needle 141 of Makower) from a retracted position (position shown in Fig. 3) within the catheter to a deployed position (position shown in Fig. 4), wherein the actuator (slider 3) comprises a predetermined stroke distance directly proportional to an ejection distance of the distal end portion of the stylet (abstract, paragraphs [0023 – 0026], [0035], and Figs. 1 – 4) (Examiner’s note: as shown in the transition between Figs. 3 and 4, the movement of the slider is directly related and proportional to the distal that the guidewire 9 (i.e., the stylet) is ejected from the distal end; additionally, as stated in paragraph [0025] the guidewire 9 (i.e., the stylet) is directly bonded to the tongue of the slider 3 (i.e., the actuator), and because there is no mention of any intervening structure, any movement of the slider (i.e., the actuator) will result in a 1 to 1 movement of the guidewire 9 (i.e., the stylet). Lastly, the distance traveled by the slider is determined prior to the traveling of the slider; therefore, the distance is pre-determined).
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 Makower to incorporate a hub and slider actuator, based the teachings of Belson, for the purpose of being able to retract and extend the stylet in and out of the lumen when needed.
As to (iii), there is no evidence of record that establishes that changing the size / diameter of the guide catheter 146 of Makower would result in a difference in function of the device of Makower. Further, a person having ordinary skill in the art, being faced with modifying the guide catheter 146 of Makower, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed size / diameter. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the size / diameter “may” be within the claimed range (e.g., specification at para. [0006]) and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guide catheter 146 of Makower to have a size / diameter within the claimed ranges as an obvious matter of design choice within the skill of the art.
Claims 5, 6, 15, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 6,159,225) (previously cited) in view of Belson (US 2012/0197200 A1) (previously cited as the WO version), as applied to claims 1, 11, and 17 above, and further in view of Merril et al (US 2003/0040737 A1) (previously cited).
Regarding claims 5, 6, 15, 16, and 20, as discussed above, the combination of Makower and Belson teaches the devices of claims 1, 11, and 20.
However, the combination is silent regarding [claims 5, 15, and 20] (i) wherein the actuator is pneumatic, hydraulic, or magnetic and [claims 6 and 16] (ii) wherein the actuator comprises a solenoid.
As to the above, Merril teaches a system for controlling a medical device comprising a catheter (endoscopic tool 3; which equates to the guide catheter 146 of Makower), a stylet (working channel tool 4; which equates to the needle 141 of Makower), and an actuator (actuator 12; which equates to the actuator of Belson) for moving the stylet (working channel tool 4) into and out of the lumen of the catheter (endoscopic tool 3), wherein the actuator (actuator 12) comprises a pneumatic, hydraulic, or magnetic actuator (abstract, paragraphs [0017 – 0020], [0023], [0025], and Figs 1 – 3). Additionally, Merril teaches wherein the actuator comprises a solenoid (moving magnetic actuator – which is a solenoid actuator) (paragraph [0023]).
It should be understood that the combination of Makower in view of Belson and Merril are known references in the art that a catheter system with an inner working member and an actuator for moving the inner working member through the lumen of the catheter system (abstract, paragraphs [0023 – 0026], [0035], and Figs. 1 – 4 – Belson ; abstract, paragraphs [0017 – 0020], [0023], [0025], and Figs 1 – 3 – Merril); 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 actuation means for another (i.e., the sliding actuator of Belson on the device of Makower for an actuation means (either the solenoid or pneumatic) based on the teachings of Merril), and the results of the substitution would have been predictable and resulted in the system of Makower in view of Belson being able to function as intended to extend and retract the stylet relative to the catheter. 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.
Response to Arguments
Applicant's arguments filed 03/26/2026 have been fully considered but they are not persuasive. More specifically:
Regarding Applicant’s arguments which are directed to the newly added limitations; the Examiner has responded to said arguments in the above rejection wherein the limitations are mapped to the prior art.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/
Primary Examiner, Art Unit 3771
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