DETAILED ACTION
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.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 25, 26, 28, 29, 32, 33, 35, 36, 38, 39, 42 and 43, is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Garrison (US 2014/0058414A1) in view of Barbut (US 6,165,199).
Regarding claims 25, 36 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 (claims 33 and 42)] 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; 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 (claims 29 and 38; stent (2115)), and treating the lesion. However, Garrison does not disclose removing the treatment catheter.
In the same field of endeavor, treating occlusions within the carotid and cerebral arteries, Barbut teaches a treatment catheter (C3:L43-67, C4:L1-6). The treatment catheter is advanced through a carotid artery and to an occlusion in a cerebral artery (claim 32), wherein aspiration is performed to remove the thromboembolic material (claims 28 and 39) 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 effective filing date of the claimed invention to have provided the method of Garrison with a treatment catheter that is positioned adjacent to a blockage, treats the blockage via aspiration and is removed, as taught by Barbut, to provide aspiration means to remove embolic debris lodged in a cerebral vessel to reestablish cerebral perfusion (C7:L64-67).
Regarding claims 27 and 40, the combination of Garrison and Barbut discloses that the access sheath includes an occlusion element (129; [0126]; Garrison) that occludes the blood vessel.
Regarding claims 30 and 37, the combination of Garrison and Barbut discloses that the treatment catheter includes a balloon catheter and inflates a balloon disposed along the balloon catheter [0196; Garrison].
Regarding claims 31, the combination of Garrison and Barbut 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; Garrison]. The sheath through which the suture delivery device is advanced is replaced with the advancement of the access sheath [0070; Garrison].
Regarding claims 34, 41 and 44, the combination of Garrison and Barbut 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; Garrison) coupled to a proximal end region of the access sheath via flowline (615; Garrison).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bose (US 2006/0058838A1) discloses a treatment catheter disposed in an access sheath and used to treat blockages. Chou et al. (US 2011/0034986A1) discloses a pre-close device used prior to insertion of an access sheath.
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