DETAILED ACTION
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
Claim Objections
Claim 9 is objected to because of the following informalities: line 5, please change “the wrapping step” to --wrapping--. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: line 5, please change “the wrapping step” to --wrapping--. Appropriate correction is required.
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) 1, 2, 6, 8, 10-12, 16, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tulleken et al. (US 2008/0109019A1, “Tulleken”) in view of Weadock et al. (US 2003/0163144A1, “Weadock”).
Regarding claims 1, 2, 6, 8, 10-12, 16, 18, and 20, Tulleken discloses a tissue connector device including a hollow body (2) having an insertion end (Fig. 1; proximal end) capable of receiving at least the end portion of a first tissue, an adjoining end (Fig. 1B), and a lumen therebetween that extends through the hollow body. A single overflap [0060] extend from the adjoining end of the hollow body, wherein Tulleken discloses that the hollow body may be cut at one position creating a single overflap. The single overflap is flexible [0045] and sized to at least partially extend around an exterior periphery of a non-end side of a second tissue and positioning the non-end side of the second tissue adjacent to the adjoining end of the hollow body. The single overflap is wrapped around at least a portion of the exterior periphery of the non-end side of the second tissue to position the non-end side of the second tissue adjacent to the adjoining end of the hollow body (Fig. 1). Tulleken teaches coattails (overflaps;[0049]) of a tissue connector device (1;Fig. 1) that are secured to the second tissue (5; [0042]) via sutures (6). However, Tulleken does not disclose inserting an end of a first tissue into an insertion end of the tissue connector device so that an end of the first tissue is received within a lumen of the tissue connector device, using one or more sutures to secure the hollow body to the first tissue.
In the same field of endeavor, anastomosis, Weadock teaches a method for creating an anastomosis between first and second vessels (102, 104) wherein the first vessel is inserted through an insertion end of a tissue connector device (106) until a terminal end of the first tissue is at or near the adjoining end of the tissue connector device (Fig. 4). An adhesive is disposed between an outer surface of the first vessel and the corresponding surface (108; [0046]) of the tissue connector device to secure the tissue connector device to the first vessel. A second securing means (pins,121; Fig. 4) secures the tissue connector device to the second vessel [0050-0051]. 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 modified the method of Tulleken with the method involving inserting a first tissue into an insertion end of a hollow body, as taught by Weadock, for the predictable result of creating an end-to-side anastomosis and ensuring the hollow body and overflaps are firmly attached to the vessels.
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tulleken in view of Weadock, as applied to claims 1 and 11 above, and further in view of Schenck (US 4,474,181).
Regarding claims 7 and 17, Tulleken does not disclose suturing the hollow body to the first tissue. In the same field of endeavor, anastomosis, Schenck teaches a method for creating an end-to-side anastomosis between vessels (12c,d) using sutures (Fig. 9). Schenck teaches a hollow body of a tissue connector device (10’;Fig. 8, 9) that is secured to the first vessel (12d) via sutures (6). 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 the combination of Tulleken and Weadock with means for securing the hollow body to the first vessel, as taught by Schenck, for the predictable result securing and stabilizing the connection between the first tissue and hollow body to ensure success of the end-to-side anastomosis.
Allowable Subject Matter
Claims 3-5, 9, 13-15, and 19 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stopek et al. (US 2010/0010517A1) discloses a tissue connector device including a single overflap but does not disclose a method directed toward an end-to-side anastomosis.
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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