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 .
Status of Claims
Claims 12-25 and 29-37 are pending.
Claims 18 and 29 have been withdrawn from consideration.
Claims 1-11 and 26-28 have been cancelled.
Priority
This application claims priority from a variety of applications, but the earliest support for the claimed subject matter is the filling date of application 16/888,813, filed 05/31/2020.
Election/Restrictions
Applicant elected: The delivery system (all method claims have been cancelled), Delivery catheter species I (Figures 1A-C), Packaging catheter species C (Figure 10), Stent Species I (Figures 2-3) in the reply filed on 04/04/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Information Disclosure Statement
The Information Disclosure Statements filed on 01/09/26 and 11/19/25 have been considered by the examiner.
Drawings
The previous drawing objections have been withdrawn in view of the applicant’s amendments.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the asymmetrical medical device/stent of claims 35-37 (as explained in more detail below the drawings make it unclear where and what shaped define the stent, as best understood the triangle 300 of Figure 1C defines the shape of the stent which is just triangular not traditionally asymmetrical, see 112 rejection for more details) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "300" and "301" have both been used to designate the stent. Figure 6 shows the triangular stent 301 but only references a single line of the triangle as being the stent and references the body of the stent as 300, but is defined in the specification as a push wire. It appears the wire line is missing from the figure. Figure 2 shows 300 as both the dashed line on the left side and a solid line offset from the original dash line on the right side. Again it appears that a separate wire line is missing from the figure. Figure 3 appears to be the only Figure properly showing the separate line and stent structures 300/301.
The applicant is requested to clarify the record with respect to the following issues with respect the elected embodiment.
Where is the stent and where is the pusher in Figures 1-6?
Is the pusher just a wire or does it include additional structure in Figures 1A-C?
If it is just a wire how does it have the claimed non-circular cross-section?
If it has additional structure where is it depicted and where does it end and where does the stent begin?
The applicant is reminded that no new matter not previously depicted or clearly described within the specification will be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The previous objection to the specification has been withdrawn in view of the applicant’s amendments.
Claim Objections
The previous objection to claim 24 has been withdrawn in view of the applicant’s amendments.
Claim Rejections - 35 USC § 112
The previous 112 rejections have been withdrawn in view of the applicant’s amendments.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 35 requires the medical device/stent to be asymmetrical, but the term “asymmetrical” is only used 2 times within the original disclosure and neither time describes the stent. Furthermore the elected embodiment of stent shown in Figures 2-3 are unclear with respect to the actual stent shape. They appear to disclose a triangle configuration similar to Figure 1C, but those triangles do not appear to be asymmetrical unless viewed from a rotated position. As explained above the figures are convoluted and fail to provide any clarity.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 12, 13, 17, 19-22, 32, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin et al (Austin) US 2008/0015674 in view of Yee et al (Yee) US 2001/0037141 A1.
12. Austin discloses the invention substantially as claimed being an intravascular system configured for insertion into a blood vessel (Figures 2A-D), the intravascular system 100 comprising:
a delivery catheter 110 defining an inner lumen (hollow interior), the inner lumen having a first non-circular cross-sectional configuration (as explained previously this phrasing is extremely broad and includes horizontally taken cross-sections as well as cross-sections taken when the device is bent or curved which will make them non-circular)
a pusher 105 configured for insertion into the inner lumen of the delivery catheter to move a medical device through the delivery catheter (Figures 2A-D).
Austin further discloses the lumen comprising a first non-circular configuration and a second lumen having a second non-circular cross-sectional configuration configured to allow axial movement within the lumen of the delivery catheter and to inhibit rotation of the pusher within the lumen of the delivery catheter to thereby maintain a pre-determined angular orientation of the pusher within the delivery catheter (Austin discloses the outer and inner components shown with circular cross-sections and discloses they can be formed with triangular cross-sections which will act in the same manner [0070]).
However, Austin does not specifically disclose the non-circular cross-sectional configuration of the pusher prevents rotational movement.
Yee teaches the use of concentric non-circular cross-sectioned members including an outer member 40, an inner member 21, and an inner pusher member 20 (all three members as shown in 7have square cross-sections) in the same in the same field of endeavor for the purpose of locking in the desired orientation and preventing unnecessary rotation (lines 20-24 of [0010]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the pusher of Austin to have the same cross-sectional shape (triangular) as the inner and outer tubes as taught by Yee in order to lock in the desired orientation and preventing any unnecessary rotation.
13. Austin as modified discloses the first non-circular configuration and the second non-circular configuration are each defined by a plurality of linear segments ([0070] discloses multiple linear line shapes like triangles and hexagons).
17. Austin as modified discloses the first non-circular configuration of the inner lumen and the second non-circular configuration of the pusher are such that the pusher is insertable into the inner lumen in at least three distinct angular orientations (this is achieved by rotating the triangular or hexagon shaped features disclosed in [0070]).
19. Austin as modified discloses a packaging catheter 112 containing the pusher (Figure 1), and the packaging catheter is configured to mate within a hub of the delivery catheter to deliver a stent through the lumen of the delivery catheter (the packaging catheter of Austin mates with the entire inner surface of the delivery catheter, no hub or hub structure is positively claimed but the packaging catheter of Austin is fully capable of mating with any rear portion of the delivery catheter which can be called a hub).
20. Austin as modified discloses the corresponding lumens and adjacent structures are non-circular shaped in [0070] therefore the packaging catheter 112 has to have a lumen having a non-circular configuration corresponding to the first non-circular configuration of the delivery catheter or it would not function.
21. Austin as modified discloses the first non-circular configuration corresponds to (corresponds is being given the broadest reasonable interpretation meaning to be similar) the second non-circular configuration (paragraph [0070] and Yee provide support from them having the same shape and small tolerance to prevent rotation.
22. Austin as modified discloses the cross-sectional configurations of the inner lumen and the pusher facilitate insertion of the pusher into the inner lumen in a plurality of discrete orientations separated by a defined angular increment (this is obtained by using the disclosed triangular shape as well as others disclosed in [0070]).
32. Austin as modified discloses the medical device is a stent 135.
34. Austin as modified discloses the medical device 135.
Claim(s) 23-25, 31, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin and Yee (Combination 1) as applied to claims 12, 13, 17, 19-22, 32, and 34 above, and further in view of Burton et al (Burton) USPN 5,026,377.
23. Austin discloses an intravascular system 100 configured for insertion into a blood vessel (Figures 2A-D), the intravascular device comprising:
a delivery catheter 110 defining an inner lumen (inner hollow space);
a pusher 105 configured for axial movement through the inner lumen of the delivery catheter (Figures 2A-D); and
a stent 135 deployable within the blood vessel via axial movement of the pusher through the delivery catheter (Figures 2A-D), the inner lumen of the delivery catheter and an outer wall of the pusher having cross-sectional configurations such that rotation of the pusher is limited within the inner lumen of the delivery catheter upon insertion of the pusher into the delivery catheter to thereby maintain a pre-determined angular orientation of a stent secured to the pusher to enable desired radial placement of the stent (See explanation above with respect to claim 12 and [0070]).
Austin discloses the stent positioned between the pusher/delivery catheter and uses the pusher to directly contact the stent and drive it out of the delivery catheter. However, Combination 1 does not disclose the stent is directly secured to the pusher.
Burton teaches that it is old and well known in the art of stent delivery catheters to directly secure the stent to the inner pusher member (2:35-45 and Figure 1).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine releasable stent securing feature of Burton with the stent bed of the pusher of Austin in order to.
24. Austin as modified discloses the cross-sectional configurations of the inner lumen and the outer wall of the pusher facilitate insertion of the pusher into the inner lumen in a plurality of discrete orientations separated by a defined angular increment (this is obtained by using the disclosed triangular shape as well as others disclosed in [0070] and Yee).
25. Austin as modified discloses the inner lumen of the delivery catheter and the pusher are configured such that the defined angular increment is at least 60 degrees (this is obtained by using the disclosed triangular shape as well as others disclosed in [0070] and Yee).
31. Austin as modified discloses a packaging catheter 112 containing the pusher (Figure 1), and the packaging catheter is configured to mate within a hub of the delivery catheter to deliver a stent through the lumen of the delivery catheter (the packaging catheter of Austin mates with the entire inner surface of the delivery catheter, no hub or hub structure is positively claimed but the packaging catheter of Austin is fully capable of mating with any rear portion of the delivery catheter which can be called a hub).
33. Austin as modified discloses the stent is directly secured to the pusher (see modification in view of Burton with respect to claim 23 above).
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin and Yee (Combination 1) as applied to claims 12, 13, 17, 19-22, 32, and 34 above, and further in view of Kaplan et al (Kaplan) USPN 5,571,086.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the use of radiopaque markers on the catheter.
Kaplan teaches the use of a stent delivery catheter comprising separate radiopaque markers 282 positioned along on the linear segmented rib members (15:21-45) in the same field of endeavor for the purpose of improving the operators visual of the catheter during surgery.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the linearly arranged radiopaque markers of Kaplan with all of the linear edges of the delivery catheter of Austin in order to improve the operators visual of the catheter during insertion and removal.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin, Yee, and Kaplan (Combination 2) as applied to claims 14-16 above, and further in view of Solovay USPN 5,769,884.
Combination 2 discloses the invention substantially as claimed being described above. However, the combination does not disclose the use of a stent with porous and nonporous regions.
Solovay teaches the use of a stent with a variety of identifiable porous and non-porous sections in the same field of endeavor for the purpose of isolating specific areas of the implant site to prevent flow from diseased portions (1:66-2:19).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize the stent of Solovay in order to provide the operator with increased control over the flow and isolation of any diseased portions of the implant site.
In regards to the requirement for the marker on the delivery catheter to enable radial alignment of the non-porous side, the known position of the markers taught by Kaplan will enable to operator to align any portion of the stent with any portion of the implant site.
Claim(s) 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin and Yee (Combination 1) as applied to claims 12, 13, 17, 19-22, 32, and 34 above, and further in view of Samson USPN 5,927,345.
Combination 1 discloses the invention substantially as claimed being described above. However, the combination does not disclose the use of a stent an asymmetrical configuration.
Samson teaches the use of a stent comprising the same triangular shape (Figure 5B as considered to be as asymmetrical as the applicant’s own invention) as the applicant’s disclosure, which can be inserted in 3 clear orientations, in the same field of endeavor for the purpose of preventing rotation.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize the triangular cross-sectioned stent of Samson in order to better fit the shape of the insertion device and to provide the stent with increased ability to not rotate within the implant site.
36. Austin as modified discloses the medical device is coupled with the pusher during insertion through the delivery catheter (see modification in view of Burton with respect to claim 23 above), wherein a relationship between an outer surface and shape of the pusher and an inner surface and shape of the delivery catheter prevent rotation of the pusher and medical device during insertion (see modification with respect to Yee with respect to claim 12).
37. Austin as modified discloses the medical device is a stent 135.
Response to Arguments
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive.
The applicant argues that Austin teaches only the outer two layers being triangular not the pusher member. This argument is not persuasive because it is old and extremely well known to form all concentrically mounted tools within medical devices with the same cross-section. This prevents formation of force concentration points and ensures smoother axial movement. Furthermore the rejection has been modified to include the teachings of Yee to have not just the outer two layers formed with similar cross-sectional shapes, but the inner pusher as well.
The applicant further argues that Austin discloses rotation between his layers and that it is a crucial aspect. This is not persuasive because Yee clearly discloses the desire for the 3 components to not rotate. Therefore the final combination will not rotate with respect to the outer layer, inner layer, or pusher member. With respect to the rotation, Austin broadly discloses numerous versions of his outer layers, slits, and allows for an abundance of assembly methods. The rotation of the inner and outer members is never described as being crucial. Austin merely mentions that they can be rotated. Austin also discloses that the inner layer can be attached to the outer layer which means that rotation in at least that configuration is not crucial. Finally, as modified by Yee there will be no need for rotation because the stent and layers can be locked into a previously identified orientation.
Finally, the applicant argues that Austin does not disclose the stent is directly interfaced or connected to the pusher. This is not persuasive because it is old and extremely well known for stents to be secured to the inner pusher member when radially expandable and utilized with a sheath. The prior art rejection has been modified to use the Burton reference for support for such a direct securement. This has the obvious benefit of preventing movement from the stent prior to insertion. Additionally, when the pusher of Austin is moved longitudinally the stent would be directly secured to the enlarged rear surface of the pusher shown in Figure 2B, but for completeness the rejection has been amended to include the teachings of Burton.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/Primary Examiner, Art Unit 3774