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 .
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.
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:
mechanical mechanism in claim 94
foot fixation element in claim 97 and claim 106.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 87-93, 95 and 100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbott et al. (US 2008/0154286A1).
Regarding claim 87, Abbott discloses a closure device including at least two pre-shaped hollow tubes (120,140; Fig. 6I; [0112-115]). Each pre-shaped hollow tube includes a proximal end positioned substantially at the proximal end of the closure device and a distal end configured to be at least partially deployed from the distal end of the closure device into a blood vessel. Upon deployment of the distal ends of the at least two pre-shaped hollow tubes, the distal ends of the at least two pre-shaped hollow tubes are, wherein tubular members (123) are capable of being retracted and extended [0112] to provide means for engagement between the distal ends of the pre-shaped hollow tubes to enable threading of a suture from a first tube to a second tube of the at least two pre-shaped hollow tubes. For example, retracting tubular member (123-2; Fig. 6I) to the same distance as tubular member (123-1) would allow the pre-shaped hollow tubes to engage when distally advanced from the distal end of the tubular members, thus providing means for threading a suture therebetween. However, the embodiment of Fig. 6I does not disclose proximal end and a distal end interconnected by a main sheath. Embodiment of Fig. 3A and 5U includes a main sheath (101) through which delivery members [0072; not shown for clarity] and needles (120, 140; Fig. 3A) are disposed. Therefore, it would have been obvious to one of ordinary skill in the art to have provided the closure device of Abbott (Fig. 6I) with a main sheath, as taught by Fig. 3A of Abbott, to provide means for insertion into the vasculature of a subject [0062].
Regarding claim 88, Abbott discloses that each of the at least two pre-shaped hollow tubes include at least two configurations. A first configuration in which the pre-shaped hollow tube is confined within the closure device and has a shape substantially parallel to the main sheath of the closure device [0111]. A second configuration in which the pre-shaped hollow tube protrudes out of the distal end of the closure device and the distal end of the pre-shaped tube has a curved shape [0111].
Regarding claim 89, Abbott discloses that the engagement of the at least two-pre-shaped hollow tubes is capable of resulting in at least one continuous passage from the proximal end of the first tube to the proximal end of the second tube of the at least two pre-shaped hollow tubes, through the engaged distal ends (Fig. 6I). It is noted that the engagement is not positively recited.
Regarding claim 90, Abbott discloses that the at least one continuous passage is capable of automatically guiding the suture from the proximal end of the first tube to the proximal end of the second tube when the suture is inserted and advanced through the at least one continuous passage. It is noted that the engagement, continuous passage and suture are not positively recited.
Regarding claim 91, Abbott discloses that the at least two pre-shaped hollow tubes are positioned externally to the main sheath of the closure device when extended distally (Fig. 6I).
Regarding claim 92, Abbott discloses that the at least two pre-shaped hollow tubes are positioned internally within the main sheath of the closure device when retracted [0111].
Regarding claim 93, Abbott discloses that the distal end of one or more of the at least two pre-shaped hollow tubes is cone-shaped (Fig. 6I).
Regarding claim 94, Abbott discloses at least one alignment element, aligning the distal ends of the tubular members (123), is capable of facilitating alignment between he at least pre-shaped hollow tubes (Fig. 6I).
Regarding claim 100, Abbott discloses that the blood vessel is capable of being a carotid artery [0193].
Allowable Subject Matter
Claim(s) 94, 96-99, 101-104 is/are 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.
Claim(s) 105-106 is/are allowed. The prior art does not disclose or suggest a method for applying a suture to a blood vessel using a closure device including a main sheath and at least two pre-shaped hollow tubes, deploying the distal ends of the at least two pre-shaped hollow tubes from the distal end of the closure device until the distal ends assume a curved shape and engagement is established therebetween, threading a suture from the proximal end of a first tube of the at least two pre-shaped hollow tubes to the proximal end of a second tube through the engaged distal ends of the at least two pre-shaped hollow tubes, in combination with the other claimed limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Scribner et al. (US 5,830,125) and Klein et al. (WO-9413211) disclose a closure device including at least two pre-shaped hollow tubes.
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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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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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771