DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 8, 2026 has been entered.
Claim Objections
Claim 12 is objected to because of the following informalities: line of claim 12 should be amended to read: “A method of using a bi-directional sheath…” to maintain consistency in the spelling of “bi-directional”. Also, line 11 of claim 12 should be amended to recite: “introducing the sheath body….” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12-21 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. The method of claim 12 sets forth removing the antegrade dilator and the retrograde dilator through the guidewire to release their respective configuration within the blood vessel. It appears from the disclosure (and Figures 4A-4D) that after the introduction step, the dilators are released from their respective deployment configurations via removal of the guidewire. There is not a clear indication of how this is facilitated “through” the guidewire as the guidewire is intended to pass through the lumen of dilators 110 and 112 as per the disclosure (see ¶¶ [0029] and [0032] of the publication). The disclosure provides support for removing the dilators from the sheath to release their respective configurations (they are constrained within the sheath during deployment), or to release the sheath to its deployed configuration (see ¶ [0065] of the publication; it is noted that the language of the disclosure makes it unclear as to what the intended release configuration is; the language supports the release of the dilators but it is the sheath that is disclosed as having a “released configuration”), but makes no mention of how the guidewire is used to achieve this function. It is therefore not clear from the instant disclosure how the final step of the method of claim 12 is performed and what structure is required to achieve the release of the dilators after positioning. For example, it’s not clear if the removal of the guidewire from the sheath assembly and dilators releases the desired configuration of the dilators and sheath or if the sheath is released into its end use configuration as depicted in Figure 1D.
Claims 12-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 12, the claim sets forth: “…introducing [the] sheath body through a guidewire to a blood vessel access site; removing the antegrade dilator and the retrograde dilator through the guidewire to release their respective configuration within the blood vessel.” The language from the claim is unclear as to how the method is to be performed. Insertion of medical devices into a target location via a guidewire is well established in the art. In general, the medical device is passed over the guidewire which is then left in place or removed from the device after reaching the target treatment site. There is no disclosure of what is meant by introducing the sheath body “through a guidewire”, or removing the dilators “through the guidewire” as claimed. As set forth in the instant disclosure at ¶ [0032], at least the retrograde dilator is advanced “over a guidewire”. Also, ¶ [0029] discloses that dilator 110 comprises a lumen used for guide wire access. This implies that the wire is located within the dilator and not within the guide wire as the term “through” implies. This is consistent with the standard insertion procedure. The claim should be amended to recite that the sheath and dilator are introduced or removed in such a way. Suitable language for replacing the term “through” would be “over”, “via”, “using”, or “along”. In addition, the final step of claim 12 which discloses “removing the antegrade dilator and the retrograde dilator through the guidewire to release their respective configuration within the blood vessel is unclear. The language implies that the two dilators are released into their respective configurations, however, the disclosure seems to provide evidence that the sheath is released into its final configuration after removal of the dilators (see page 20, lines 7-9 of the disclosure as filed; also ¶ [0065] of the publication). The scope of the claim is therefore unclear as to what end configuration the method step is disclosing. The claim should be amended to recite that the dilators are removed over the guidewire to release the sheath body’s respective configuration within the blood vessel. This is how the claim will be interpreted for examination. Claims 13-21 are rejected due to their dependence on claim 12.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 5, and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richter et al. (US 5,755,735).
Regarding claim 1, Richter et al. (henceforth Richter) discloses (Figures 18-21) a bi-directional sheath (stent 110, 140) system comprising: a sheath body (formed from 119, 140; Figure 21) having an elongated cylindrical body (along 110) and defining an interior lumen (longitudinal bore 131) in communication with a first opening (at distal, furthest end from outside the patient, end of 110; see annotated figure below) at the proximal end and a second opening (opposite end of 110; see annotated figure below) at the distal end and a third opening (side opening 135 for receiving stent portion 140; e.g., Figure 19) located between the first opening and the second opening of the sheath body (Figure 19); wherein the sheath body comprises an antegrade dilator (170, 175) and a retrograde dilator (171, 176), wherein the antegrade dilator comprises a lumen connecting the first opening to the second opening (the inflation lumen provides fluid access from adjacent the second opening through to the first opening; the claims don’t require fluid connection between the first and second openings), and the retrograde dilator comprises a lumen connecting the second opening to the third opening (the inflation lumen provides fluid access from adjacent the second opening to the third opening as claimed; the claims don’t require fluid connection between the first and second openings through the sheath body via the dilator); wherein the antegrade dilator and the retrograde dilator are removable from the sheath body (Col. 7, lines 12-15 disclose that after deploying the stent sections, the first and second balloons are withdrawn and the stent or sheath is left in place).
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Regarding claim 2, Richter further discloses wherein the distance between the first opening and the third opening is less than the distance between the second opening and the first opening (it can be seen in Figure 20 that the third opening of the sheath is closer to the first opening than the second opening as claimed).
Regarding claim 4, Richter further discloses wherein the retrograde dilator comprises at least one preformed curve at a proximal end, wherein the at least one preformed curve is at least partially flexible (Figure 19, it can be seen that catheter 171 and balloon 176 are curved as they exit the side opening and therefore the curve is considered preformed as it curves before deploying the sheath portion 140 for fully establishing the sheath body; e.g., it’s preformed relative to the sheath and not the procedure).
Regarding claim 5, Richter further discloses wherein the sheath body (110, 140) further comprises a side lumen (bore of 140 after deployment) fluidly connected to the sheath body through the third opening (Figure 19, the branch stent, after inflation and securement, forms the side lumen of the sheath as claimed).
Regarding claim 12, Richter discloses a method of using a bi-directional sheath system comprising: providing a bi-directional sheath system having a sheath body (110, 140) having an elongated cylindrical body (Figures 18-19) and defining an interior lumen (within stent 110) in communication with a first opening (see annotated figure above, opening furthest from outside the patient) at a proximal end, a second opening (opposite first end) at a distal end (see annotated figure above), and a third opening (Figure 18, see annotated figure above) between the first opening and the second opening; wherein the sheath body comprises an antegrade dilator (170, 175) and a retrograde dilator (171, 176), wherein the antegrade dilator and the retrograde dilator are removable from the sheath body (Col. 7, lines 12-15 disclose that after deploying the stent sections, the first and second balloons are withdrawn and the stent or sheath is left in place); inserting the antegrade dilator and the retrograde dilator into the sheath interior lumen (see Figure 15 wherein both dilators are inserted into the sheath body before insertion; Col. 6, lines 27-46); introducing the sheath body through a guide wire to a blood vessel access site (Col. 6, lines 36-41 discloses inserting both catheters into the sheath main body for deployment within the target vessel); removing the antegrade dilator and the retrograde dilator through the guidewire to release their respective configuration within the blood vessel (Col. 7, lines 10-15 disclose removing both catheters from the deployed stent).
Regarding claim 13, Richter further discloses wherein the distance between the first opening and the third opening is less than the distance between the second opening and the first opening (it can be seen in Figure 20 that the third opening of the sheath is closer to the first opening than the second opening as claimed).
Regarding claim 14, Richter further discloses wherein the retrograde dilator comprises at least one preformed curve at a proximal end, wherein the at least one preformed curve is at least partially flexible (Figure 19, it can be seen that catheter 171 and balloon 176 are curved as they exit the side opening and therefore the curve is considered preformed as it curves before deploying the sheath portion 140 for fully establishing the sheath body; e.g., it’s preformed relative to the sheath and not the procedure).
Regarding claim 15, Richter further discloses wherein the sheath body (110, 140) further comprises a side lumen (bore of 140 after deployment) fluidly connected to the sheath body through the third opening (Figure 19, the branch stent, after inflation and securement, forms the side lumen of the sheath as claimed).
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) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richter in view of Brucker et al. (US 2003/0097169).
Regarding claims 6 and 16, Richter discloses the claimed invention substantially as set forth above for claims 5 and 12, and further discloses the side lumen as being formed at an angle relative to the sheath body (see annotated figure above). However, Richter fails to explicitly disclose the claimed angle range of 25 degrees – 75 degrees.
Brucker et al. (henceforth Brucker) teaches (Figure 5) a bifurcated stent assembly (52, 54) wherein the branch vessel portion of the assembly is formed at an angle of between 25 degrees-75 degrees (¶ [0070] discloses an angle of between 10 degrees – 120 degrees).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the angle of the side lumen relative to the primary portion of the stent body of Richter to be within the claimed angle of 25 degrees – 75 degrees since Brucker teaches that such an angle is known for bifurcated stent assemblies depending on the angle of the branch vessel its being installed into (¶ [0070]).
Allowable Subject Matter
Claims 7-11 and 17-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claims 17-21, claim 12 must also be amended to overcome the rejections under 35 U.S.C. 112(a) and 112(b) set forth above.
The following is an examiner’s statement of reasons for allowance: the prior art made of record and relied upon does not anticipate or render obvious, alone or in combination, the features of the cited claims. Richter is considered the closest prior art of record which discloses a stent (analogous to a sheath absent more defined structure or function), and a plurality of dilators for deploying the stent at a target site. Regarding claims 7-8 and 17-18, Richter fails to disclose wherein the stent body comprises a side port at the distal end (closer to the insertion end). It would not have been obvious to one of ordinary skill in the art at the time of filing to modify the stent of Richter to comprise a side port on a distal end thereof as the stent is intended to remain in the body after deployment and therefore it would be unreasonable to apply a port to any portion of the stent body as it would interfere with blood flow and/or retention of the device at the site. Claims 8 and 18 would be allowable based on their dependence from claims 7 and 17. Regarding claims 9 and 19, for similar reasons, it would not be obvious to modify the stent to comprise an intraluminal balloon and fluid coupling on the sheath body as it would interfere with the function of the stent device. The same reasoning applies to claims 10-11 and 20-21 which disclose a trapdoor structure which would not be obvious to place into a deployed stent body. For at least these reasons, and including the totality of the claimed structure, the claims would be allowable over the prior art made of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783