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 .
Formal Matters
Applicant’s Response and Amendments filed 11 May 2026 are acknowledged.Claims 1, 5, and 12 are currently amended. Claims 1-20 are pending and under examination.
Objections/Rejections Withdrawn
The rejection of claims 5 on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent 11,090,056 (17 August 2021) is withdrawn in light of Applicant’s amendment. The genus of a static mixing component in the ‘056 patent does not anticipate the species of structures in amended claim 5.
The rejection of claims 1, 2, 4-8, 10-17, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krishnan US 20160166242 (16 June 2016), is withdrawn in light of Applicant’s arguments and amendments.
The rejection of claim 3 under 35 U.S.C. 103 as being unpatentable over Krishnan US 20160166242 (16 June 2016) in view of Kassab, US 20100286718 (11 November 2010), is withdrawn in light of Applicant’s arguments and amendments.
The rejection of claims 9 and 18 under 35 U.S.C. 103 as being unpatentable over Krishnan US 20160166242 (16 June 2016) in view of Hartley et al., US 20080132937 (5 June 2008), is withdrawn in light of Applicant’s arguments and amendments.
The rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over Krishnan US 20160166242 (16 June 2016) in view of Hartley et al., US 20080132937 (5 June 2008) and further in view of Kassab, US 20100286718 (11 November 2010), is withdrawn in light of Applicant’s arguments and amendments.
Response to Arguments
Applicant’s amendments to the claims to obviate the claim interpretation under 35 USC 112(f) is noted. Applicant requests that the ODP rejection held in abeyance. Applicant’s request is denied. Objections as to matters as to form may be held in abeyance during prosecution. Replies with an omission are treated as provided in MPEP 714.03. See MPEP 804.02 (VI).
Obviousness-Type Double Patenting (Non-Provisional)
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 1-4, 6-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent 11,090,056 (17 August 2021), for the reasons of record and the reasons set forth herein.
This is a non-provisional rejection. US Patent 11,090,056 has the same inventive entity and appears to be commonly owned. If so, a terminal disclaimer under 37 CFR 1.321 would overcome the Obviousness-Type Double Patenting rejection.
Although the claims at issue are not identical, they are not patentably distinct due to anticipation or obviousness of the claims of the ‘056 patent. Claims 9, 16, and 18 of the current application recite features from the end-of-claim clause in the ‘056 patent claim 1. These differences would have been obvious given their express inclusion in claim 1 of the ‘056 patent and because the patent’s specification teaches that the diaphragm of the third catheter body can occlude the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction (col 7, lines 56-62).
A chart is set forth below showing the side-by-side claim comparison. The obvious variations in the claims are distinguished by italics with the respective related claim numbers of the ‘135 application indicated.
The amendments to claims 1 and 12 filed 11 May 2026, are merely descriptive and do not further limit the structures over the recitation of the corresponding claims of the ‘056 patent. Tubular-shaped structures comprising lumens are generally understood to have an outer surface and an inner surface.
US 11,090,056
18/939,135
1. A catheter assembly comprising:
a first catheter body having a proximal end portion,
a distal end portion having a distal tip, and a wall that circumferentially encloses a primary opening,
wherein the first catheter body further comprises at least one inflation channel within the wall of the first catheter body,
wherein the primary opening of the first catheter body extends along an entire length of the first catheter body;
a first balloon coupled to the distal end portion of the first catheter body and
positioned in fluid communication with the at least one inflation channel of the first catheter body,
the first balloon enclosing an interior space,
wherein the first catheter body extends through the interior space of the first balloon in a proximal-to-distal direction such that at least the distal tip of the first catheter body is positioned distal of the first balloon;
a second catheter body partially received within the primary opening of, and selectively moveable relative to, the first catheter body,
wherein the second catheter body has a proximal end portion, a distal end portion having a tip, and a wall that circumferentially encloses a primary opening,
wherein the second catheter body further comprises at least one inflation channel within the wall of the second catheter body, wherein the primary opening of the second catheter body extends along an entire length of the second catheter body;
a second balloon coupled to the distal end portion of the second catheter body and positioned in fluid communication with the at least one inflation channel of the second catheter body,
the second balloon enclosing an interior space,
wherein the second catheter body extends through the interior space of the second balloon in the proximal-to-distal direction such that at least the distal tip of the second catheter body is positioned distal of the second balloon; and
a third catheter body partially received within the primary opening of, and selectively moveable relative to, the second catheter body,
wherein the third catheter body has a proximal end portion, a distal end portion, and a wall structure that defines at least one injection channel extending from the proximal end portion toward the distal end portion,
wherein the distal end portion of the third catheter body further comprises at least one outlet opening positioned in fluid
communication with the at least one injection channel,
wherein the distal end portion of the third catheter body has a distal tip and a diaphragm that is secured to the distal tip, the diaphragm extending outwardly from the distal tip,
wherein the third catheter body is selectively retractable relative to the second catheter body, and
wherein when the third catheter body is retracted to be fully received within the primary opening of the second catheter body,
the diaphragm of the third catheter body occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
A catheter assembly comprising:
a first catheter body having a proximal end portion,
a distal end portion having a distal tip, and
a wall having an outer surface and an inner surface that circumferentially encloses a primary opening,
wherein the first catheter body further comprises at least one inflation channel within the wall of the first catheter body between the inner surface and the outer surface,
wherein the primary opening of the first catheter body extends along an entire length of the first catheter body;
a first balloon coupled to the distal end portion of the first catheter body and
positioned in fluid communication with the at least one inflation channel of the first catheter body,
the first balloon enclosing an interior space,
wherein the first catheter body extends through the interior space of the first balloon in a proximal-to-distal direction such that at least the distal tip of the first catheter body is positioned distal of the first balloon;
a second catheter body partially received within the primary opening of, and selectively moveable relative to, the first catheter body,
wherein the second catheter body has a proximal end portion, a distal end portion having a tip, and a wall having an outer surface and an inner surface that circumferentially encloses a primary opening,
wherein the second catheter body further comprises at least one inflation channel within the wall of the second catheter body between the inner surface and the outer surface of the second catheter body,
wherein the primary opening of the second catheter body extends along an entire length of the second catheter body;
a second balloon coupled to the distal end portion of the second catheter body and positioned in fluid communication with the at least one inflation channel of the second catheter body,
the second balloon enclosing an interior space,
wherein the second catheter body extends through the interior space of the second balloon in the proximal-to-distal direction such that at least the distal tip of the second catheter body is positioned distal of the second balloon; and
a third catheter body partially received within the primary opening of, and selectively moveable relative to, the second catheter body,
wherein the third catheter body has a proximal end portion, a distal end portion, and a wall structure that defines at least one injection channel extending from the proximal end portion toward the distal end portion,
wherein the distal end portion of the third catheter body further comprises at least one outlet opening positioned in fluid communication with the at least one injection channel.
9. wherein the distal end portion of the third catheter body has a distal tip and a diaphragm that is secured to the distal tip, the diaphragm extending outwardly from the distal tip.
16. withdrawing the third catheter body into the primary opening of the second catheter body.
18. withdrawing the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body,
18. wherein a diaphragm secured to a distal tip of the third catheter body occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
2. The catheter assembly of claim 1, wherein the at least one injection channel of the third catheter body comprises a plurality of injection channels.
2. The catheter assembly of claim 1, wherein the at least one injection channel of the third catheter body comprises a plurality of injection channels.
3. The catheter assembly of claim 1, wherein the at least one injection channel of the third catheter body comprises first and second injection channels, and wherein the wall structure of the third catheter body comprises an outer wall and an inner wall that extends between opposing portions of the outer wall to define the first and second injection channels.
3. The catheter assembly of claim 1, wherein the at least one injection channel of the third catheter body comprises first and second injection channels, and wherein the wall structure of the third catheter body comprises an outer wall and an inner wall that extends between opposing portions of the outer wall to define the first and second injection channels.
4. The catheter assembly of claim 1, wherein the at least one outlet opening of the distal end portion of the third catheter body comprises a plurality of outlet openings.
4. The catheter assembly of claim 1, wherein the at least one outlet opening of the distal end portion of the third catheter body comprises a plurality of outlet openings.
6. The catheter assembly of claim 1, wherein, in an inflated position, the second balloon is larger than the first balloon.
6. The catheter assembly of claim 1, wherein, in an inflated position, the second balloon is larger than the first balloon.
7. The catheter assembly of claim 1, wherein the wall of the first catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the first balloon.
7. The catheter assembly of claim 1, wherein the wall of the first catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the first balloon.
8. The catheter assembly of claim 1, wherein the wall of the second catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the second balloon.
8. The catheter assembly of claim 1, wherein the wall of the second catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the second balloon.
9. The catheter assembly of claim 1, wherein the second catheter body is selectively retractable relative to the first catheter body.
10. The catheter assembly of claim 1, wherein the second catheter body is selectively retractable relative to the first catheter body.
10. The catheter assembly of claim 1, wherein the first and second catheter bodies are selectively lockable to maintain a desired position and orientation of the second catheter body relative to the first catheter body.
11. The catheter assembly of claim 1, wherein the first and second catheter bodies are selectively lockable to maintain a desired position and orientation of the second catheter body relative to the first catheter body.
11. A method comprising: deploying the catheter assembly of claim 1;
selectively inflating the first balloon to occlude a first opening;
selectively advancing the second catheter body relative to the first catheter body;
selectively inflating the second balloon to occlude a second opening;
selectively advancing the third catheter body relative to the second catheter body;
selectively delivering at least one injectable material to the at least one injection channel of the third catheter body; and
delivering the at least one injectable material to a selected delivery site through the at least one outlet opening of the third catheter body.
12. A method comprising: deploying the catheter assembly of claim 1;
selectively inflating the first balloon to occlude a first opening;
selectively advancing the second catheter body relative to the first catheter body;
selectively inflating the second balloon to occlude a second opening;
selectively advancing the third catheter body relative to the second catheter body;
selectively delivering at least one injectable material to the at least one injection channel of the third catheter body; and
delivering the at least one injectable material to a selected delivery site external to the catheter assembly through the at least one outlet opening of the third catheter body.
12. The method of claim 11, wherein the first opening is an inter-atrial septum of a heart, wherein the second opening is an ostium of a left atrial appendage of the heart, and wherein the selected delivery site is the left atrial appendage of the heart.
13. The method of claim 12, wherein the first opening is an inter-atrial septum of a heart, wherein the second opening is an ostium of a left atrial appendage of the heart, and wherein the selected delivery site is the left atrial appendage of the heart.
13. The method of claim 12, wherein the first balloon is positioned on a left atrial septal side of the inter-atrial septum, wherein the second balloon is positioned proximally of the ostium of the left atrial appendage, and wherein the first balloon provides axial support for the second balloon to maintain occlusion of the left atrial appendage.
14. The method of claim 13, wherein the first balloon is positioned on a left atrial septal side of the inter-atrial septum, wherein the second balloon is positioned proximally of the ostium of the left atrial appendage, and wherein the first balloon provides axial support for the second balloon to maintain occlusion of the left atrial appendage.
14. The method of claim 13, further comprising: pulling the first catheter body in a proximal direction to press the first balloon against the inter-atrial septum; and pushing the second catheter body in a distal direction to press the second balloon against the ostium of the left atrial appendage.
15. The method of claim 14, further comprising: pulling the first catheter body in a proximal direction to press the first balloon against the inter-atrial septum; pushing the second catheter body in a distal direction to press the second balloon against the ostium of the left atrial appendage.
15. The method of claim 11, further comprising withdrawing the third catheter body into the primary opening of the second catheter body.
16. The method of claim 12, further comprising withdrawing the third catheter body into the primary opening of the second catheter body.
16. The method of claim 15, wherein the at least one injectable material is delivered to the selected delivery site through the at least one outlet opening of the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body.
17. The method of claim 16, wherein the at least one injectable material is delivered to the selected delivery site through the at least one outlet opening of the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body.
17. The method of claim 15, further comprising withdrawing the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body, wherein a diaphragm secured to a distal tip of the third catheter body occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
18. The method of claim 16, further comprising withdrawing the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body, wherein a diaphragm secured to a distal tip of the third catheter body occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
18. The method of claim 17, further comprising allowing the second balloon and the third catheter body to occlude the second opening and the primary opening of the second catheter body until the at least one injectable material is sufficiently hardened within the delivery site.
19. The method of claim 18, further comprising allowing the second balloon and the third catheter body to occlude the second opening and the primary opening of the second catheter body until the at least one injectable material is sufficiently hardened within the delivery site.
19. The method of claim 11, further comprising locking the first and second catheter bodies in position prior to the step of advancing the third catheter body relative to the second catheter body.
20. The method of claim 12, further comprising locking the first and second catheter bodies in position prior to the step of advancing the third catheter body relative to the second catheter body.
New Objection – Necessitated by Amendment
Allowable Subject Matter - Claim Objections
Claim 5 is 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.
Krishnan US 20160166242 (16 June 2016) teaches a catheter comprising an inner sheath, an outer sheath, an inner catheter, and four inflatable balloons, but does not teach separate inflation channels in the first and second catheters as recited in amended claims 1 and 12. Krishnan does not teach inflation channels between the inner surface and the outer surface of the first catheter body and inflation channels between the inner surface and the outer surface of the second catheter body. Kassab et al., US 20100286718 (11 November 2010) teaches an inflation source operatively coupled to the first tube, but not to additional tubes or catheter bodies. Kassab ‘718 also teaches a third catheter body comprising an injection channel (lumen), but does not teach a catheter body disclosed around the exterior of the second catheter body. Similarly, Hartley et al., US 20080132937 (5 June 2008), does not teach these limitations.
Conclusion
Claim 5 is objected to. Claims 1-4 and 6-20 are rejected.
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 CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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