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.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 9 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rapacki et al. (US 2004/0113306A1, “Rapacki”).
Regarding claim 1, Rapacki discloses a tissue connector device capable of end-to-side connection of tissues. The tissue connector includes a hollow body (160; [0095]) having an adjoining end opposite an insertion end and at least two overflaps (186; Fig. 18) defined by at least two U-shaped lateral cut-outs at the adjoining end. Each of the at least two lateral U-shaped cut-outs has a U-shape when viewed from a side, perpendicular to a central longitudinal axis of the tissue connector device (Fig. 18).
Regarding claim 2, Rapacki discloses that two of the at least two U-shaped lateral cut-outs are opposite to each other and offset from each other relative to the central longitudinal axis of the tissue connector device (Fig. 18).
Regarding claim 9, Rapacki discloses that the hollow body is a continuous tubular construct (Fig. 18).
Regarding claim 11, Rapacki discloses that a diameter of the lumen at the adjoining end is approximately the same as a diameter of the lumen at the insertion end (Fig. 18).
Claim Rejections - 35 USC § 103
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) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Arani et al. (US 2005/0149073A1, “Arani”).
Regarding claims 4 and 5, Rapacki does not disclose that the hollow body and the at least two overflaps are formed of a biomaterial that is transparent, semi-transparent or translucent. In the same field of the endeavor, connector devices for anastomosis, Arani teaches a connector device that is formed of biomaterials (synthetic sources, e.g. polytetrafluoroethylene (PTFE), polyetherteraphalate (PET), that are translucent or transparent [0079]. 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 substituted the material of the hollow body of Rapacki with a translucent, transparent or semi-transparent biomaterial, as taught by Arani, as this modification involves the simple substitution of one material for another for the predictable result of providing a tubular construct used as an anastomotic connector. The transparent or translucent material allows the surgeon to more easily see the placement of the conduit within the connector [0079].
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Wu et al. (US 2016/0331866A1, “Wu”).
Regarding claims 4 and 6, Rapacki does not disclose that the hollow body and the at least two overflaps are formed of a biomaterial that is transparent, semi-transparent or translucent. In the same field of the endeavor, tissue repair, Wu teaches a device formed of semi-transparent biomaterials, e.g. collagen [0030]. 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 material of the hollow body of Rapacki of semi-transparent collagen, as taught by Wu, to allow the surgeon to more easily see the placement of the conduit within the connector.
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Bates et al. (US 2005/0038455A1, “Bates”).
Regarding claims 7 and 10, Rapacki does not disclose that the hollow body and the at least two overflaps are formed of a biomaterial, e.g. small intestine submucosa (SIS). In the same field of the endeavor, anastomosis devices, Bates teaches a device formed of SIS [0033; Fig. 3A]. The hollow body (15) is non-continuous tubular construct of a rolled material (Fig. 2). 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 substituted the material of the hollow body of Rapacki with SIS material, as taught by Bates, as this modification involves the simple substitution of one material for another for the predictable result of forming the hollow body of a biomaterial which helps reduce complications, improve healing and reduce the body’s immune response.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Furst et al. (US 2006/0106455A1, “Furst”).
Regarding claims 8, Rapacki does not disclose that the hollow body and the at least two overflaps are formed of a biomaterial including porous HDPE or PEG surrounded by a layer of non-porous HDPE or PEG. In the same field of the endeavor, biomaterials of medical devices, Furst teaches a device formed of polyethylene glycol (PEG; [0019, 0020]). The device may include one or more porous and/or non-porous polymer material [0019, 0026]. 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 substituted the material of the hollow body of Rapacki with the non-porous and porous layered PEG material, as taught by Furst, as this modification involves the simple substitution of one material for another for the predictable result of providing a biomaterial having low toxicity, low immunogenicity, functional flexibility and safety.
Claim(s) 3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Fleischman et al. (US 6,494,889, “Fleischman”).
Regarding claims 3 and 10, Rapacki does not disclose that the hollow body is a non-continuous tubular construct of rolled material. In the same field of endeavor, anastomosis, Fleischman teaches a tubular construct formed of rolled material (34;Fig. 4B; C12;L35-36). 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 tubular construct of the hollow body of a rolled material, as taught by Fleischman, for the predictable result of providing a tubular construct to provide means to create an end-side fitting.
Regarding claim 3, the combination of Rapacki and Fleischman discloses that the at least two U-shaped lateral cut-outs are offset from each other, relative to the central longitudinal axis of the tissue connector device, wherein Fleischman teaches that the number of overflaps (petals; 44; [0085]) may be as little as one or two to as many as sixteen or more. An odd number of overflaps results in cut-outs being offset from one another.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Stopek et al. (US 2010/0010517A1, “Stopek”).
Regarding claim 12, Rapacki does not disclose an insertion end that includes a diameter of the lumen at the insertion end is greater than a diameter of the lumen at the adjoining end. In the same field of endeavor, anastomosis, Stopek teaches a hollow body (52) that narrows in diameter towards the distal end [0053; Fig. 5A]. 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 insertion end of Rapacki with a greater diameter of the lumen at the adjoining end, as taught by Stopek, to provide means to accommodate a body lumen without damage the vessel lumen.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Fleischman et al. (US 6,494,889, “Fleischman”).
Regarding claim 13, Rapacki discloses a tissue connector device capable of end-to-side connection of tissues. The tissue connector includes a hollow body (160; [0095]) having an adjoining end opposite an insertion end and at least two overflaps (186; Fig. 18) defined by at least two U-shaped lateral cut-outs at the adjoining end. Each of the at least two lateral U-shaped cut-outs has a U-shape when viewed from a side, perpendicular to a central longitudinal axis of the tissue connector device (Fig. 18). However, Rapacki does not disclose that the lateral cut-outs are V-shaped.
In the same field of endeavor, anastomosis, Fleischman teaches a tubular construct including slots formed by cut-outs (54;Fig. 7A). The cut-outs assist in the end-side fitting. 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 substituted the C-shaped cut-outs with V-shaped cut-outs, as taught by Fleischman, as this modification involves the simple substitution of one material for another for the predictable result of providing a tubular construct to create an end-side fitting.
Regarding claim 14, the combination of Rapacki and Fleischman discloses that two of the at least two V-shaped lateral cut-outs are opposite to each other and offset from each other relative to the central longitudinal axis of the tissue connector device (Fig. 18; Rapacki).
Regarding claim 15, the combination of Rapacki and Fleischman discloses that the at least two V-shaped lateral cut-outs are offset from each other, relative to the central longitudinal axis of the tissue connector device, wherein Fleischman teaches that the number of overflaps (petals; 44; [0085]) may be as little as one or two to as many as sixteen or more. An odd number of overflaps results in cut-outs being offset from one another.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Fleischman, as applied to claim 13 above, and further in view of Arani et al. (US 2005/0149073A1, “Arani”).
Regarding claims 16 and 17, the combination of Rapacki and Fleischman does not disclose that the hollow body and the at least two overflaps are formed of a biomaterial that is transparent, semi-transparent or translucent. In the same field of the endeavor, connector devices for anastomosis, Arani teaches a connector device that is formed of biomaterials (synthetic sources, e.g. polytetrafluoroethylene (PTFE), polyetherteraphalate (PET), that are translucent or transparent [0079]. 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 substituted the material of the hollow body of the combination of Rapacki and Fleischman with a translucent, transparent or semi-transparent biomaterial, as taught by Arani, as this modification involves the simple substitution of one material for another for the predictable result of providing a tubular construct used as an anastomotic connector. The transparent or translucent material allows the surgeon to more easily see the placement of the conduit within the connector [0079].
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Fleischman, as applied to claim 13 above, and further in view of in view of Bates et al. (US 2005/0038455A1, “Bates”).
Regarding claims 18, the combination of Rapacki and Fleischman does not disclose that the hollow body and the at least two overflaps are formed of a biomaterial, e.g. small intestine submucosa (SIS). In the same field of the endeavor, anastomosis devices, Bates teaches a device formed of SIS [0033; Fig. 3A]. The hollow body (15) is non-continuous tubular construct of a rolled material (Fig. 2). 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 substituted the material of the hollow body of the combination of Rapacki and Fleischman with SIS material, as taught by Bates, as this modification involves the simple substitution of one material for another for the predictable result of forming the hollow body of a biomaterial which helps reduce complications, improve healing and reduce the body’s immune response.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Fleischman et al. (US 2002/0013591A1, “Fleischman”).
Regarding claim 19, Rapacki discloses a tissue connector device capable of end-to-side connection of tissues. The tissue connector includes a hollow body (160; [0095]) having an adjoining end opposite an insertion end and at least two overflaps (186; Fig. 18) defined by at least two U-shaped lateral cut-outs at the adjoining end. Each of the at least two lateral U-shaped cut-outs has a U-shape when viewed from a side, perpendicular to a central longitudinal axis of the tissue connector device (Fig. 18). However, Rapacki does not disclose that the lateral cut-outs are rectangular-shaped.
In the same field of endeavor, anastomosis, Fleischman teaches a tubular construct (80) including formed by rectangular-shaped cut-outs (54;Fig. 3A). The cut-outs assist in the end-side fitting. 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 substituted the U-shaped cut-outs with rectangular-shaped cut-outs, as taught by Fleischman, as this modification involves the simple substitution of one material for another for the predictable result of providing a tubular construct to create an end-side fitting.
Regarding claim 20, the combination of Rapacki and Fleischman discloses that two of the at least two rectangular-shaped lateral cut-outs are opposite to each other and offset from each other relative to the central longitudinal axis of the tissue connector device (Fig. 18; Rapacki).
Regarding claim 21, the combination of Rapacki and Fleischman discloses that the at least two rectangular-shaped lateral cut-outs are offset from each other, relative to the central longitudinal axis of the tissue connector device, wherein Fleischman teaches that the number of overflaps (petals; 44; [0085]) may be as little as one or two to as many as sixteen or more. An odd number of overflaps results in cut-outs being offset from one another.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rapacki in view of Fleischman, as applied to claim 13 above, and further in view of Arani et al. (US 2005/0149073A1, “Arani”).
Regarding claim 22, the combination of Rapacki and Fleischman does not disclose that the hollow body and the at least two overflaps are formed of a biomaterial that is transparent, semi-transparent or translucent. In the same field of the endeavor, connector devices for anastomosis, Arani teaches a connector device that is formed of biomaterials (synthetic sources, e.g. polytetrafluoroethylene (PTFE), polyetherteraphalate (PET), that are translucent or transparent [0079]. 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 substituted the material of the hollow body of the combination of Rapacki and Fleischman with a translucent, transparent or semi-transparent biomaterial, as taught by Arani, as this modification involves the simple substitution of one material for another for the predictable result of providing a tubular construct used as an anastomotic connector. The transparent or translucent material allows the surgeon to more easily see the placement of the conduit within the connector [0079].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Solem (US 6179848) discloses an end-to-side fitting having multiple petals and rectangular cut-outs.
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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