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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 8th, 2025, has been entered.
Response to Amendment
The claims filed on December 8th, 2025, have been entered. Claims 1-2, 5-6, and 8-20 remain pending in the Application. Claims 8-20 were previously withdrawn by the Applicant. Claim 7 has been canceled by the Applicant.
Response to Arguments
Applicant's arguments filed December 8th, 2025, have been fully considered but they are not persuasive.
Regarding the Double Patenting rejections, Applicant argues that the amendment to claim 1 overcomes the previous Double Patenting rejections of claims 1-2 and 5-6 under U.S. Patent No. 11,253,266. Examiner respectfully disagrees. The amended claim 1, which now includes the limitation of canceled claim 7, is still anticipated by patent claims 1 and 5 of the ‘266 patent, as was pointed out in the Final Rejection dated August 8th, 2025, for the double patenting rejection of application claim 7. Furthermore, application claim 2 was anticipated solely by patent claim 1 of ‘266, and patent claims 1 and 5 still anticipate the application claim 2. However, Examiner does agree that application claims 5-6 are no longer anticipated by patent claims 2-3, respectively, as the limitations from patent claim 5 are not included in patent claims 2-3.
Applicant argues that Wallace et al. (U.S. Patent No. 9,060,777) does not teach a delivery sleeve that is a separate and distinct component from a catheter, and instead teaches a catheter itself. Examiner respectfully disagrees. As pointed out in the Final Rejection dated August 8th, 2025, Applicant’s assertion is based on the position that because Wallace et al. teaches a catheter, that the catheter cannot comprise a delivery sleeve. However, both are structurally a cylindrical object with a longitudinal lumen, and so the catheter 28 of Wallace et al. satisfies the structural limitation of “delivery sleeve.” Furthermore, one catheter may be inside another catheter, so the argument that Wallace et al. already has a catheter and therefore cannot have a catheter surrounding the delivery sleeve is not persuasive.
Applicant further argues that Wallace et al. does not disclose a stop in catheter hub 38 because catheter hubs connect part of a catheter to another device. Examiner respectfully disagrees. As pointed out in the Final Rejection, a stop is only a structural component capable of limiting the distance that the delivery sleeve is inserted into the catheter. Since the structure of 38 juts out from the body of 28, a catheter which is smaller in diameter than 38 but greater in diameter than 28 would be stopped by 38 when sliding along 28 towards 38. Therefore, 38 of Wallace et al. satisfies the structural requirements of a stop. Furthermore, since Applicant further defines the stop in the claim as comprising an attachment mechanism to connect the proximal end of the catheter to other devices, the argument that a catheter hub is distinct from the claimed limitations because a catheter hub connects to another device is not persuasive.
Applicant further argues that Wallace et al. teaches away from using a stop based on C1:L45-C2:L11. Examiner respectfully disagrees. While Wallace et al. notes that U.S. Patent No. 7,749,242 has an internal stop attached to a central inner member, Wallace et al. only teaches away from the cited patents by stating that the small coils used in those cited patents are less desirable because they require longer and more complicated procedures, and does not state any disadvantage related to the stop.
The rejection of claims 1-2 and 5-6 under 102(a)(1) and 103 over Wallace et al. in view of Look et al. (Pub. No. 2017/0181760) has been withdrawn in light of Applicant’s amendment made December 8th, 2025; specifically, neither reference discloses the stop comprises an attachment mechanism to connect to the proximal end of the catheter.
Applicant’s arguments with respect to claim(s) 1-2 and 5-6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that Applicant argues that the newly added claim limitations are not taught by Wallace et al.; however, as discussed below, the newly added reference Sharma (Pub. No. 2024/0108392) teaches said 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 § 112
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.
Claims 1-2 and 5-6 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.
Claim 1 recites the limitation "the proximal end of the catheter" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim. No proximal end of a catheter has been previously introduced in claim. Claim 1 should be amended to correct the antecedent basis. Claims 2 and 5-6 are rejected for their dependency on claim 1.
Claim 1 recites the limitation "a proximal end of the catheter" in lines 14-15. A proximal end of a catheter has been previously introduced in the claim in lines 12-13, and the claim is unclear on whether these are the same limitation or different limitations. For purposes of claim interpretation, the two recited proximal ends of the catheter are being treated as one and the same, as best understood.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,253,266. Although the claims at issue are not identical, they are not patentably distinct from each other because application claims 1-2 are anticipated by patent claim 5.
Regarding application claim 1, patent claim 1 of ‘266 discloses an endovascular apparatus (C14:L17) comprising a delivery sleeve having a longitudinal lumen extending between a proximal end and a distal end (C14:L18-19); a therapeutic device housed within and extending substantially an entire length of the delivery sleeve (C14:L20-21); wherein the therapeutic device includes one or more detachable polymer endovascular embolization coils (C14:L22-23); and a stop positioned on the proximal end of the delivery sleeve which is operable to limit a distance the delivery sleeve is inserted into a catheter (C14:L28-30); wherein an outside diameter of the delivery sleeve is sufficiently small such that the delivery sleeve is insertable into the catheter (C14:L31-32), and further recites an advancement mechanism configured to engage the therapeutic device to advance the therapeutic device into a patent, and a diameter of the lumen is sufficiently large such that the lumen is able to coaxially receive the therapeutic device and the advancement mechanism therein, but sufficiently small that the deliver sleeve adds longitudinal strength to the therapeutic device. Patent claim 5 of ‘266 is dependent on patent claim 1 of ‘266, and further discloses the stop is a luer connection operable to engage an opposing luer connection on a proximal end of the catheter (C14:L59-61). Therefore, patent claim 5 of ‘266 anticipates application claim 1.
Regarding application claim 2, patent claim 1 of ‘266 further discloses an advancement mechanism configured to engage the therapeutic device to advance the therapeutic device into a patent (C14:L25-27). Since patent claim 5 of ‘266 is dependent on patent claim 1 of ‘266, patent claim 5 of ‘266 also anticipates application claim 2.
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 5-6 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).
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 5, Wallace et al. as modified further discloses 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).
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771