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
In response to the amendment filed on 12/16/2024, Claims 1-28 have been cancelled and newly added Claims 29-53 are pending.
Election/Restrictions
Applicant’s election WITHOUT traverse of GROUP I in the reply filed on 03/02/2026 is acknowledged. Claims 49-53 have been withdrawn from further consideration and Claims 29-48 are pending.
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 29 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 12,076,259. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Present Claim 29, Claim 20 (which includes the limitations of Claim 1 by dependency) of Pat’259 discloses a percutaneous transluminal angioplasty device, comprising (Claim 1; Column 16, Lines 2):
a multi-lumen catheter having a proximal portion and a distal portion, the multi-lumen catheter defining a first lumen, a second lumen, and a third lumen each extending through at least a portion of the multi-lumen catheter (Claim 1; Column 16, Lines 3-6);
a filter disposed on the multi-lumen catheter and being movable between an unexpanded configuration and an expanded configuration (Claim 1; Column 16, Lines 7-9);
a filter activation wire coupled to the filter and extending through at least a portion of the first lumen (Claim 1; Column 16, Lines 12-13);
an expandable balloon disposed on the multi-lumen catheter (Claim 1; Column 16, Lines 17-18);
a self-expanding stent extending over at least a portion of the expandable balloon (Claim 1; Column 16, Lines 19-20);
a movable sheath extending over at least a portion of the self-expanding stent (Claim 1; Column 16, Lines 21-22);
a sheath wire coupled to the movable sheath and extending through at least a portion of the second lumen (Claim 1; Column 16, Lines 23-24);
a guidewire extending through at least a portion of the third lumen (Claim 1; Column 17, Lines 27-28);
a first handle control coupled to the filter via the filter activation wire and configured to move the filter between the unexpanded configuration and the expanded configuration (Claim 20, Lines 29-31; wherein the first handle control is the first actuation knob); and
a second handle control independently operable from the first handle control, the second handle control coupled to the movable sheath via the sheath wire and configured to retract the movable sheath axially (Claim 20, Lines 32-34; wherein the second handle control is the second actuation knob).
Regarding Present Claim 41, Claim 20 of Pat’259 discloses the percutaneous transluminal angioplasty device of Claim 29, wherein the first handle control and the second handle control are coupled to a handle (Claim 20 discloses that the handle comprises the first and second actuation knobs/controls).
Claims 29, 35, and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,138,187. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Present Claim 29, Claim 9 (which includes the subject matter of Claims 5 and 8 by dependency) of Pat’187 discloses a percutaneous transluminal angioplasty device, comprising (Column 16, Lines 2):
a multi-lumen catheter having a proximal portion and a distal portion, the multi-lumen catheter defining a first lumen, a second lumen (Claim 1; Column 16, Lines 2-5), and a third lumen (Claim 5; Column 16, Lines 61-63) each extending through at least a portion of the multi-lumen catheter (Claim 1; Column 16, Lines 5-6);
a filter disposed on the multi-lumen catheter and being movable between an unexpanded configuration and an expanded configuration (Claim 1; Column 16, Lines 7-9);
a filter activation wire coupled to the filter and extending through at least a portion of the first lumen (Claim 1; Column 16, Lines 12-13);
an expandable balloon disposed on the multi-lumen catheter (Column 1; Column 16, Lines 17-18);
a self-expanding stent extending over at least a portion of the expandable balloon (Claim 1; Column 16, Lines 19-20);
a movable sheath extending over at least a portion of the self-expanding stent (Claim 1; Column 16, Lines 21-22);
a sheath wire coupled to the movable sheath and extending through at least a portion of the second lumen (Claim 1; Column 16, Lines 23-24);
a guidewire extending through at least a portion of the third lumen (Claim 9);
a first handle control coupled to the filter via the filter activation wire and configured to move the filter between the unexpanded configuration and the expanded configuration (Claim 1; Column 16, Lines 27-30); and
a second handle control independently operable from the first handle control, the second handle control coupled to the movable sheath via the sheath wire and configured to retract the movable sheath axially (Claim 1; Column 16, Lines 31-33).
Regarding Present Claim 35, Claim 9 (which includes the subject matter of Claim 8 by dependency) of Pat’187 discloses the percutaneous transluminal angioplasty device of Claim 29, wherein the multi-lumen catheter defines a guidewire port (Claim 8, Column 17, Lines 7-8) defined by the third lumen (as recited in Claim 9) .
Regarding Present Claim 41, Claim 9 (which includes the subject matter of Claim 1 by dependency) of Pat’187 discloses the percutaneous transluminal angioplasty device of Claim 29, wherein the first handle control and the second handle control are coupled to a handle (Claim 1; Column 16, Lines 27-28).
Allowable Subject Matter
Claims 29, 35, and 41 would be allowable by filing a Terminal Disclaimer to overcome the double patenting rejection(s) set forth in this Office action.
Claims 30-34, 36-40 and 42-43 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.
Claims 44-48 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record, Frimerman (US PGPub 2012/0330346), Sachar (US PGPub 2005/0228438), and Broome (US Patent 6,391,050), does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of Independent Claims 44. which recite, inter alia " the handle having a first handle control knob and a second handle control knob…a proximal catheter portion including a sheath activation lumen… a sheath movable between an extended sheath position covering the expandable balloon and a retracted sheath position exposing the expandable balloon, wherein the sheath is actuated between the extended sheath position and the retracted sheath position by the second handle control knob via the sheath activation lumen".
The closest prior arts of record disclosed above teaches a percutaneous transluminal angioplasty device similar to that of Claims 44-48, however the prior art disclosed above fails to teach the claim language outlined above.
Because none of the prior art documents of record teach a percutaneous transluminal angioplasty device as recited in Claims 44-48, in view of the prior art at its deficiencies, Applicant’s invention is rendered novel and non-obvious and thus is allowable as claimed.
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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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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) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771