DETAILED ACTION
This Office Action is in response to the Amendment filed 22 September 2026. Claim(s) 25-44 are currently pending. The Examiner acknowledges cancelled claim(s) 1-24.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
The claim limitation ‘closure device’ in claims 25 and 43 is construed under 35 U.S. 112(f). The limitation includes nonce term “device” and the term “closure” is a function but lacks a description of the structure. In paragraph [0152] the closure device is disclosed as placing one or more sutures across a vessel access site such that, when the suture ends are tied off after sheath removal, the stitch or stitches provide hemostasis to the access site. The sutures can be applied either prior to insertion of a procedural sheath through the arteriotomy or after removal of the sheath.
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.
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 25, 32 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,144,915 in view of Barbut (US 6,165,199). Claim 1 of the reference patent recites all of the limitations of claim 25 and claim 43 of the instant application except “removing the treatment catheter,”. However, Barbut teaches another method for treating occlusions within the carotid and cerebral arteries. A treatment catheter (C3:L43-67, C4:L1-6) is advanced through a carotid artery and to an occlusion in a cerebral artery, a treatment is performed to remove the thromboembolic material and the treatment catheter is withdrawn (C7:L64-67). Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to have removed the treatment catheter after treating a lesion within a cerebral blood vessel in the method of claims 1 of the reference patent to provide means for additional treatment devices or to prepare for conclusion of the surgery and closing of the site.
Every limitation in the application under examination claims is recited in the conflicting reference patent claims and the differences between the claims are highlighted below by bolding all limitations that differ, italicizing additional limitations and underlining limitations that are addressed above.
Instant Claims
Reference U.S. Patent No. 12,144,915
25 and 32. A method for treating a blood vessel, the method comprising: forming a percutaneous opening into a blood vessel; disposing a closure device at least partially within the blood vessel by advancing the closure device through the percutaneous opening; disposing an access sheath at least partially within the blood vessel by advancing the access sheath through the percutaneous opening; advancing a treatment catheter through the access sheath to a position within the blood vessel adjacent an intravascular lesion; treating the intravascular lesion with the treatment catheter; removing the treatment catheter; removing the access sheath; and closing the percutaneous opening with the closure device.
1. A method for treating stroke, comprising: forming a penetration in a wall of common carotid artery; applying a closure device upon commencement of the procedure at a site of the penetration and before placement of any structure through the penetration; positioning an arterial access sheath having an occlusion element through the penetration such that the occlusion element is positioned within an internal carotid artery; occluding the internal carotid artery; inserting a distal catheter having an aspiration lumen into an intracranial artery through the access sheath, the distal catheter further having a distal-most end that defines an opening into the aspiration lumen; treating a thrombotic blockage in the intracranial artery by positioning the distal-most end of the distal catheter so that the distal-most end is located immediately adjacent the thrombotic blockage in the intracranial artery; aspirating material from the thrombotic blockage in the intracranial artery into the opening at the distal-most end of the distal catheter such that the aspiration causes the material from the thrombotic blockage to flow into the opening at the distal-most end of the distal catheter; removing the arterial access sheath from the penetration; and closing the penetration with sutures of the closure device.
43. A method for treating a cerebral blood vessel, the method comprising: forming a percutaneous opening into a carotid artery; disposing a closure device at least partially within the carotid artery by advancing the closure device through the percutaneous opening; disposing an access sheath at least partially within the carotid artery by advancing the access sheath through the percutaneous opening; advancing a treatment catheter through the access sheath, through the carotid artery, and to a position within a cerebral blood vessel adjacent an intravascular lesion; treating the intravascular lesion with the treatment catheter; removing the treatment catheter; removing the access sheath; and closing the percutaneous opening with the closure device.
1. A method for treating stroke, comprising: forming a penetration in a wall of common carotid artery; applying a closure device upon commencement of the procedure at a site of the penetration and before placement of any structure through the penetration; positioning an arterial access sheath having an occlusion element through the penetration such that the occlusion element is positioned within an internal carotid artery; occluding the internal carotid artery; inserting a distal catheter having an aspiration lumen into an intracranial artery through the access sheath, the distal catheter further having a distal-most end that defines an opening into the aspiration lumen; treating a thrombotic blockage in the intracranial artery by positioning the distal-most end of the distal catheter so that the distal-most end is located immediately adjacent the thrombotic blockage in the intracranial artery; aspirating material from the thrombotic blockage in the intracranial artery into the opening at the distal-most end of the distal catheter such that the aspiration causes the material from the thrombotic blockage to flow into the opening at the distal-most end of the distal catheter; removing the arterial access sheath from the penetration; and closing the penetration with sutures of the closure device.
Claims 25, 32 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,103,627 in view of Barbut (US 6,165,199). Claim 1 of the reference patent recites all of the limitations of claim 25 and claim 43 of the instant application except “removing the treatment catheter,”. However, Barbut teaches another method for treating occlusions within the carotid and cerebral arteries. A treatment catheter (C3:L43-67, C4:L1-6) is advanced through a carotid artery and to an occlusion in a cerebral artery, a treatment is performed to remove the thromboembolic material and the treatment catheter is withdrawn (C7:L64-67). Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to have removed the treatment catheter after treating a lesion within a cerebral blood vessel in the method of claims 1 of the reference patent to provide means for additional treatment devices or to prepare for conclusion of the surgery and closing of the site.
Every limitation in the application under examination claims is recited in the conflicting reference patent claims and the differences between the claims are highlighted below by bolding all limitations that differ, italicizing additional limitations and underlining limitations that are addressed above.
Instant Claims
Reference U.S. Patent No. 11,103,627
25. 25 and 32. A method for treating a blood vessel, the method comprising: forming a percutaneous opening into a blood vessel; disposing a closure device at least partially within the blood vessel by advancing the closure device through the percutaneous opening; disposing an access sheath at least partially within the blood vessel by advancing the access sheath through the percutaneous opening; advancing a treatment catheter through the access sheath to a position within the blood vessel adjacent an intravascular lesion; treating the intravascular lesion with the treatment catheter; removing the treatment catheter; removing the access sheath; and closing the percutaneous opening with the closure device.
1. A method for treating stroke, comprising: forming a penetration in a wall of a common carotid artery or internal carotid artery; applying a closure device with sutures upon commencement of the procedure at a site of the penetration and before placement of any structure through the penetration; positioning an arterial access sheath having an occlusion element through the penetration such that the occlusion element is positioned within the internal carotid artery; occluding the internal carotid artery; establishing retrograde blood flow through the internal carotid artery distal of the occlusion element; inserting a distal catheter having an aspiration lumen into the intracranial artery through the access sheath, the distal catheter further having a distal-most end that defines an opening into the aspiration lumen; treating a thrombotic blockage in the intracranial artery by positioning the distal-most end of the distal catheter so that the distal-most end is located immediately adjacent the thrombotic blockage in the intracranial artery; aspirating material from the thrombotic blockage in the intracranial artery into the opening at the distal-most end of the distal catheter such that the aspiration causes the material from the thrombotic blockage to flow into the opening at the distal-most end of the distal catheter; removing the arterial access sheath from the penetration; and closing the access site with the sutures of the closure device.
43. A method for treating a cerebral blood vessel, the method comprising: forming a percutaneous opening into a carotid artery; disposing a closure device at least partially within the carotid artery by advancing the closure device through the percutaneous opening; disposing an access sheath at least partially within the carotid artery by advancing the access sheath through the percutaneous opening; advancing a treatment catheter through the access sheath, through the carotid artery, and to a position within a cerebral blood vessel adjacent an intravascular lesion; treating the intravascular lesion with the treatment catheter; removing the treatment catheter; removing the access sheath; and closing the percutaneous opening with the closure device.
1. A method for treating stroke, comprising: forming a penetration in a wall of a common carotid artery or internal carotid artery; applying a closure device with sutures upon commencement of the procedure at a site of the penetration and before placement of any structure through the penetration; positioning an arterial access sheath having an occlusion element through the penetration such that the occlusion element is positioned within the internal carotid artery; occluding the internal carotid artery; establishing retrograde blood flow through the internal carotid artery distal of the occlusion element; inserting a distal catheter having an aspiration lumen into the intracranial artery through the access sheath, the distal catheter further having a distal-most end that defines an opening into the aspiration lumen; treating a thrombotic blockage in the intracranial artery by positioning the distal-most end of the distal catheter so that the distal-most end is located immediately adjacent the thrombotic blockage in the intracranial artery; aspirating material from the thrombotic blockage in the intracranial artery into the opening at the distal-most end of the distal catheter such that the aspiration causes the material from the thrombotic blockage to flow into the opening at the distal-most end of the distal catheter; removing the arterial access sheath from the penetration; and closing the access site with the sutures of the closure device.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 25-31 and 33-44 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Garrison (US 2014/0058414A1).
Regarding claim 36, Garrison discloses a system of treating a blood vessel including a closure device [0054, 0055; one or more sutures (claim 42)] capable of being advanced through the percutaneous opening and at least partially into a carotid artery [0009, 0017, 0019, 0054,0083-0084; wherein the suture delivery device (5) is disposed within the artery] prior to the arterial access sheath being advanced through the percutaneous opening. An arterial access sheath (605/110; [0071, 0107, 0115]; procedural sheath) is capable of being advanced through the percutaneous opening and at least partially within a carotid artery. An interventional catheter (2110; [0193] or balloon catheter [0169,0194, 0196; wherein balloon catheter includes aspiration device in form of lumens or channels; claim 39) is capable of being advanced through the access sheath. The closure device is capable of closing the percutaneous opening after the interventional catheter and the access sheath are removed from the opening [0198; Fig. 41]. The closure device is capable of closing the percutaneous opening after the interventional catheter (removed in Fig. 40E) and the access sheath are removed from the percutaneous opening [0198].
Regarding claims 25 and 43, Garrison discloses a method of treating a blood vessel including forming a percutaneous opening into a blood vessel [0083-0084; access to the carotid artery (claim 26) is achieved percutaneously via an incision or puncture in the skin through which an arterial access device is inserted, an arteriotomy is performed in the carotid artery via transcervical access]. A closure device [0054; one or more sutures (claim 33)] is at least partially disposed within the blood vessel by advancing the closure device through the percutaneous opening prior to an arterial access sheath [0009, 0017, 0019, 0054,0083-0084; 0198; wherein the suture delivery device (5) is disposed within the artery; (claim 35)]. An arterial access sheath (605/110; [0071, 0107, 0115]; procedural sheath) that is disposed at least partially within the blood vessel by advancing the access sheath through the percutaneous opening. The access sheath is withdrawn and the percutaneous opening is closed with the closure device [000, 0119, 0198]. A treatment/interventional catheter (2110) is advanced through the access sheath to a position within the blood vessel adjacent the blockage (Fig. 40; [0193]), wherein the treatment catheter includes a stent delivery system (claim 29; stent (2115)), and treating the lesion (Figs. 40; [0196; wherein treatment includes aspiration of blood and debris from the treated area without need for an additional device; claim 28]). The percutaneous opening is closed with the closure device after the treatment/interventional catheter (removed in Fig. 40E) and the access sheath are removed from the percutaneous opening [0198].
Regarding claims 27 and 40, Garrison discloses that the access sheath includes an occlusion element (129; [0126]) that occludes the blood vessel.
Regarding claims 30 and 37, Garrison discloses that the treatment catheter includes a balloon catheter and inflates a balloon disposed along the balloon catheter [0196].
Regarding claims 31, Garrison discloses advancing the access sheath to a position adjacent to a cerebral blood vessel wherein the suture delivery device which includes the closure device gains access to the carotid artery and intracerebral artery to treat an intracerebral artery stenosis [0083]. The sheath through which the suture delivery device is advanced is replaced with the advancement of the access sheath [0070].
Regarding claims 34, 41 and 44, Garrison discloses establishing retrograde blood flow within the blood vessel by causing blood to flow through the access sheath and into a shunt (120; Fig. 20) coupled to a proximal end region of the access sheath via flowline (615).
Response to Arguments
Applicant’s arguments with respect to claim(s) 25, 36 and 43 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fulkerson et al. (US 2009/0105722A1) discloses a method for treating ischemic stroke within a cerebral vessel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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