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 8 is objected to because of the following informalities: lines 4-5, please change “the wrapping step” to --wrapping--. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: line 4, please change “the wrapping step” to --wrapping--. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: line 4, 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, 7, 8, 10, 11, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki et al. (US 2004/0113306A1, “Rapacki”) in view of Weadock et al. (US 2003/0163144A1, “Weadock”) in view of Schenck (US 4,474,181) in view of Tulleken et al. (US 2008/0109019A1).
Regarding claims 1 and 2 7 8 10 11, 16-19, Rapacki discloses a method including a tissue connector device including a hollow body having an insertion end (36; Fig. 2; [0069]) capable of receiving at least the end portion of a first tissue, an adjoining end (46), and a lumen therebetween that extends through the hollow body. At least two overflaps (48) extend from the adjoining end of the hollow body. The at least two overflaps 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 at least two overflaps are formed by two slits between neighboring sides of two overflaps (Fig. 18). At least one of the at least two overflaps are 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. 2). The non-end side of the second tissue is positioned so that the second tissue is received within the slit prior to wrapping. However, Rapacki 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 secured the at least two overflaps to the second tissue and 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). 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 Rapacki 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.
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 Rapacki 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.
In the same field of endeavor, anastomosis, Tulleken teaches a method for creating an end-to-side anastomosis including attachments using sutures [0041]. Tulleken teaches coattails (overflaps;[0049]) of a tissue connector device (1;Fig. 1) that are secured to the second vessel (5; [0042]) 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 Rapacki and Weadock with means for securing the overflaps to the second vessel, as taught by Tulleken, for the predictable result securing and stabilizing the connection between the second tissue and hollow body to ensure success of the end-to-side anastomosis.
Claim(s) 10, 11, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki et al. (US 2004/0113306A1, “Rapacki”) in view of Weadock et al. (US 2003/0163144A1, “Weadock”).
Regarding claims 10, 11, 16, 17, Rapacki discloses a method including a tissue connector device including a hollow body having an insertion end (36; Fig. 2; [0069]) capable of receiving at least the end portion of a first tissue, an adjoining end (46), and a lumen therebetween that extends through the hollow body. At least two overflaps (48) extend from the adjoining end of the hollow body. The at least two overflaps 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 at least two overflaps are formed by two slits between neighboring sides of two overflaps (Fig. 18). At least one of the at least two overflaps are 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. 2). The non-end side of the second tissue is positioned so that the second tissue is received within the slit prior to wrapping. However, Rapacki 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 secured the at least two overflaps to the second tissue and 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 Rapacki 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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki, Weadock, Schenck and in view of Tulleken, as applied to claim 1 above, and further in view of Scholz et al. (US 6,273,912, “Scholz”).
Regarding claims 9, the combination of Rapacki, Weadock, Schenck and Tulleken does not disclose that the at least two overflaps have different lengths. In the same field of endeavor, anastomosis, Scholz teaches a tissue connector device (10) including flanges (overflaps, 18, 20) that are of different lengths (Fig. 4B). 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 formed the overflaps of the combination of Rapacki, Weadock, Schenck and Tulleken of different lengths, as taught by Scholz, to provide means for the surgeon to determine the necessary symmetry by identifying the position of the second vessel and maximizing the strength of the tissue connector device.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Weadock, as applied to claim 10 above, and further in view of Scholz et al. (US 6,273,912, “Scholz”).
Regarding claims 20, the combination of Rapacki and Weadock does not disclose that the at least two overflaps have different lengths. In the same field of endeavor, anastomosis, Scholz teaches a tissue connector device (10) including flanges (overflaps, 18, 20) that are of different lengths (Fig. 4B). 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 formed the overflaps of the combination of Rapacki and Weadock of different lengths, as taught by Scholz, to provide means for the surgeon to determine the necessary symmetry by identifying the position of the second vessel and maximizing the strength of the tissue connector device.
Allowable Subject Matter
Claims 3-6 and 12-15 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. Deister et al. (US 2017/0224436A1) discloses a device used to connect nerves via an end-to-end anastomosis as opposed to 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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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
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance: Regarding claim 1, the prior art does not disclose a method for connecting an end portion of a first tissue adjacent to a side of a second tissue including inserting an end of the first tissue into an insertion end of a hollow body, at least two overflaps extending from an adjoining end of the hollow body, wrapping at least one of the at least two overflaps 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, using one or more sutures to secure that at least two overflaps to the second tissue, using one or more sutures to secure the hollow body to the first tissue, and in combination with the other claimed limitations.
Regarding claim 10, the prior art does not disclose a method for connecting an end portion of a first tissue adjacent to a side of a second tissue including inserting an end of the first tissue into an insertion end of a hollow body, at least two overflaps extending from an adjoining end of the hollow body, wrapping at least one of the at least two overflaps around at least a portion of the side of the second tissue to position the side of the second tissue adjacent to the adjoining end, securing the at least two overflaps to the second tissue, securing the hollow body to the first tissue, and in combination with the other claimed limitations.
The closest prior art includes Deister et al. (US 2017/0224436A1) that discloses a hollow body that includes at least two flaps (Fig. 8B; [0041]). Rapacki et al. (US 7,285,235) discloses an end-to-side method including a hollow body having an adjoining end with at least two overflaps (Fig. 2). Golden et al. (US 2004/0050393A1) discloses an anastomosis that is used in an end-to-side method for connecting tissue and a hollow body including a plurality of overflaps (Fig. 1). However, Deister et al., Golden et al. and Rapacki et al. do not teach the method of inserting an end of a first tissue into an insertion end of the hollow body, wrapping the at least two overflaps around a portion of a side of a second tissue, using sutures to secure the overflaps and the hollow body to the tissues. It would not have been obvious nor is there any motivation to modify the method of Rapacki et al., Deister et al. or Golden et al. to include inserting a first tissue into the insertion end of the hollow body, wrapping the at least two overflaps around a side of a second tissue, and suturing the overflaps to the second tissue and the hollow body to the first tissue. Additionally, no other references, or reasonable combination thereof, could be found which disclose or suggest these features in combination with other limitations in the claims.
Prosecution Insights