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
The claims filed on April 9th, 2026, have been entered. Claims 1-2, 6, and 8-20 remain pending in the Application. Claim 5 was canceled by the Applicant. Claims 8-20 were previously withdrawn by the Applicant. The claim amendments overcome the 112b rejections and double patenting rejections.
Response to Arguments
Applicant's arguments filed April 9th, 2026, have been fully considered but they are not persuasive.
First, Applicant argues that Wallace et al. (U.S. Patent No. 9,060,777) does not disclose an endovascular apparatus comprising a delivery sleeve, a therapeutic device, and a stop for insertion into a catheter, and instead discloses a vaso-occlusion system comprising a delivery catheter and a vaso-occlusive device disposed within the catheter. Examiner respectfully disagrees. As previously pointed out in the Final Rejection dated August 8th, 2025, a catheter and a sleeve are both structurally a cylindrical object with a longitudinal lumen, so catheter 28 of Wallace et al. satisfies the limitation “delivery sleeve.” Furthermore, a therapeutic device and a vaso-occlusive device are both medical implants, and the only limitations to the therapeutic device as claimed are that the device is housed within and extends the length of the delivery device, and that the device includes one or more detachable polymer endovascular embolization coils, which 22 of Wallace et al. satisfies by being made of polymer (C14-L1-10), being detachable from the catheter 28 (C29:L53-58), and being made of endovascular embolization coils (C14:L51-58). Finally, Wallace et al. discloses a stop in 38. Therefore, Wallace et al. satisfies the claim limitations.
Second, Applicant argues that Wallace et al. does not teach a delivery sleeve that is separate from a catheter, and instead teaches just a catheter. Examiner respectfully disagrees. This argument was previously addressed in the Non-Final Rejection dated January 9th, 2026, as the catheter of Wallace et al. satisfies the structural limitation of a delivery sleeve, and one catheter may be inside another catheter, so the argument that Wallace et al. already provides a catheter and therefore cannot have a catheter surrounding catheter 28 is not persuasive.
Third, Applicant argues that Wallace only lists PTFE among a broad, non-limiting set of possible materials, and does not recognize that PTFE is being selected for its low coefficient of friction. Examiner respectfully disagrees. Applicant states in [0028] of the present Specification that the delivery sleeve is made of PTFE, which means Applicant acknowledges that a delivery sleeve made of PTFE has the claimed properties of a low coefficient of friction. Wallace et al. does not need to select PTFE for a specific purpose; as long as one of ordinary skill in the art knows that PTFE can be selected as the material for the delivery sleeve, the known properties of that selection are disclosed. Since Wallace et al. discloses catheter 28 can be made of PTFE in C28:L26-28 and 50, Wallace et al. discloses a delivery sleeve which satisfies the claim limitation.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: advancement mechanism in claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In claim 2, the generic placeholder “advancement mechanism” is coupled with the functional language “configured to engage the therapeutic device to advance the therapeutic device” without reciting any additional structure to accomplish the advancement function, nor including any structural modifiers. The present Specification indicates in [0032] that the advancement mechanism can be a pusher wire or similar mechanism for pushing the therapeutic device out of the delivery sleeve.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (U.S. Patent No. 9,060,777) in view of Sharma (Pub. No. 2024/0108392).
Regarding claim 1, Wallace et al. discloses an endovascular apparatus (26; C29:L53-C30:L7; FIGs. 27A-27F) comprising:
a delivery sleeve (28) having a longitudinal lumen (FIG. 27A: 28 has a longitudinal lumen) extending between a proximal end (FIG. 27A: the lumen of 28 starts at the proximal end) and a distal end (FIG. 27A: the lumen of 28 ends at the distal end);
a therapeutic device (22) housed within and extending substantially an entire length of the delivery sleeve (FIG. 27A: 22 is housed within the lumen of 28, and extends for substantially the length of 28);
wherein the therapeutic device includes one or more detachable polymer endovascular embolization coils (C29:L53-58: 22 is detachable from 28; C14:L1-10: the implant is made of polymers; C14:L51-58: the implant comprises coils which are used for endovascular embolization; and C17:L11-14/C26:L35-39: the implants comprise coil assemblies); and
a stop (38) positioned on the proximal end of the delivery sleeve ([0222] 38 is at the proximal end of 28; FIG. 27A) which limits a distance the delivery sleeve is inserted into a catheter (FIG. 27A illustrates 38 would limit the distance that 28 can be inserted into a catheter, as a catheter with a greater diameter than 28 but a smaller diameter of 38 would only partially be able to fit 28 before 38 acts as a stop);
wherein an outside diameter of the delivery sleeve is sufficiently small such that the delivery sleeve is insertable into the catheter (the delivery sleeve only needs to be capable of being inserted into a catheter, and 28 is capable of being placed inside a larger catheter),
wherein both an inner surface and an outer surface of the delivery sleeve are composed of a material with a low coefficient of friction (the present spec [0028] discloses the delivery sleeve is made of PTFE; C28:L26-28 and 50: 28 can be made of PTFE).
Wallace et al. does not disclose the stop comprises an attachment mechanism to connect a proximal end of the catheter, where the attachment mechanism is a luer connection that engages an opposing luer connection on the proximal end of the catheter.
Sharma discloses a device (720; FIG. 7B; [0257]) comprising a catheter (722) and a delivery sheath (721) with an attachment mechanism (726), where the attachment mechanism is a luer connection ([0257] 726 is a luer lock between 721 and 722 at their proximal ends) operable to engage an opposing luer connection on a proximal end of the catheter ([0257] 726 connects 721 and 722, where each of 721 and 722 have part of 726 to connect to the other’s proximal end) for the purpose of providing a vapor-tight seal between the different lumens of the catheter and the delivery sheath ([0257]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to replace the stop of Wallace et al. with a luer connection operable to engage an opposing luer connection on a proximal end of the catheter, as taught by Sharma, for the purpose of allowing the delivery sleeve to form a vapor-tight seal between the different lumens of the delivery sheath and a catheter having a complementary luer connection.
Regarding claim 2, Wallace et al. as modified further discloses an advancement mechanism (30; C29:L53-58; FIG. 27A; as discussed above, “advancement mechanism” is being interpreted under 112(f) as a pusher wire, and 30 is a pusher wire) configured to engage the therapeutic device to advance the therapeutic device into a patient (C30:L8-16: 30 pushes 22 into the target site; FIGs. 27A-27F).
Regarding claim 6, Wallace et al. as modified further discloses the therapeutic device extends approximately to the distal end of the delivery sleeve (FIG. 27B: 22 extends approximately to the distal end of 28).
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.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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