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 .
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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 5, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4, 6-8, and 13-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “the step of embedding the plurality of helically oriented tines” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 depends from claim 3 and recites the limitation “further comprising the step of embedding the plurality of helically oriented tines” in lines 1-2. The claim is unclear as to whether this step of embedding refers to the “step of embedding” recited in claim 3 or a different step, thus rendering the claim indefinite.
Claim 6 recites the limitation “the step of engaging a tissue connection device” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the step of engaging a tissue connection device” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 is rejected as being dependent from claim 7 and failing to remedy the indefiniteness issue.
Claim 13 recites the limitation “the delivery graft component” in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claims 14-17 are rejected as being dependent from claim 13 and failing to remedy the indefiniteness issue.
Claim Rejections - 35 USC § 102
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.
Claims 1, 5-10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gifford, III et al. (U.S. Patent No. 5817113; hereinafter “Gifford”).
Regarding claim 1, Gifford discloses a method for making an end-to-side anastomosis (Figs. 45A-45E), comprising the steps of:
a. attaching a tissue connection device to an anatomic tissue (255) having an anatomic lumen, the tissue connection device comprising an annular ring (534) having a plurality of tines (535) projecting from a distal end of the annular ring (col. 54, ll. 10-24) and a tubular graft (254) coupled to the annular ring (Fig. 45A; col. 56, ll. 48-62);
b. embedding the plurality of tines into the anatomic tissue to affix the tissue connection device to the anatomic tissue (Fig. 45C; col. 57, ll. 30-60);
c. coring the anatomic tissue through the tubular graft (Fig. 45D; col. 57, ln. 61 – col. 58, ln. 6); and
d. establishing communication from the anatomic lumen of the anatomic tissue to the tubular graft (Fig. 45E; col. 5, ln. 61 – col. 58, ln. 6).
Regarding claim 5, the method of Griffin discloses wherein the step of coring further comprises the steps of:
a. Engaging a plurality of coring tines (568, 569) into the anatomic tissue col. 56, ll. 10-13);
b. Coring the anatomic tissue with a coring knife about the plurality of coring tines (col. 56, ll. 13-20); and
c. Removing the cored anatomic tissue on the coring tines through the tubular graft (Fig. 45D; col. 57, ln. 61 – col. 58, ln. 3).
Regarding claim 6, Griffin discloses wherein the step of engaging a tissue connection device further comprises the step of providing the annular ring with the tubular graft coupled thereto such that a distal end of the tubular graft projects beyond a distal aspect of the annular ring (Fig. 45A; col. 55, ll. 10-19).
Regarding claim 7, Griffin discloses wherein the step of engaging a tissue connection device further comprises the step of providing a delivery tool (553; Fig. 45A; col. 54, ll. 38-57) engaged with the annular ring, the graft delivery tool comprising an axial compression sleeve (559) having a plurality of projections (col. 54, ll. 43-49) from a distal end of the axial compression sleeve and a handle (560) at a proximal end of the axial compression sleeve, the axial compression sleeve having an inner diameter that accommodates the tubular graft member concentrically within the axial compression sleeve (Fig. 45A).
Regarding claim 8, Griffin discloses wherein the delivery tool further comprises a driver component (559) comprising a tubular member having a plurality of engagement sections at a distal end of the tubular member and a handle (560) at a proximal end of the tubular member (Fig. 45A; col. 54, ll. 49-57), the tubular member being configured to be concentrically positioned between the axial compression sleeve and the tubular graft member and removably engage with the annular ring (Fig. 45A; col. 57, ll. 30-60).
Regarding claim 9, Griffin discloses the step of rotating the plurality of coring tines in an opposite direction from the plurality of tines on the annular ring (col. 49, ll. 29-63).
Regarding claim 10, Griffin discloses after the coring step, the step of deploying a stent (534; Griffin discloses that an attachment flange serves as a stent to prevent closure of the anastomosis; col. 9, ll. 10-12) having a circumferential distal flange (541) projecting radially from a central longitudinal axis of the stent and a tubular section (537) through the tubular graft such that the circumferential distal flange abuts a luminal wall of the anatomic passageway and the tubular section of the stent abuts a luminal wall of the tubular graft (Fig. 45A; col. 55, ll. 1-19).
Regarding claim 12, Griffin discloses wherein the step of embedding the plurality of tines further comprises the step of everting at least some of the plurality of tines toward a proximal aspect of the tissue connection device within the anatomic tissue (Figs. 45C-45E).
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin.
Regarding claim 2, the method of Griffin discloses the invention substantially as claimed, except for providing the tissue connection device with a plurality of staple members (535) instead of helically oriented tines to attach a tissue connection device to anatomic tissue.
However, Griffin teaches that a tissue connection device having helical oriented tines is an equivalent structure known in the art as a tissue connection device having staple members to attach a tissue connection device to anatomic tissue (Figs. 40A-40D; col. 49, ll. 8-63).
Therefore, because these two tissue connection device configurations were art-recognized equivalents before the effective filing date of the claimed invention, a person having ordinary skill in the art would have found it obvious to substitute the step of providing the tissue connection device with a plurality of helically oriented tines for the tissue connection device with staple members to achieve the predictable result of connecting the tissue connection device with anatomic tissue and since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Regarding claim 3, Griffin discloses the step of embedding the plurality of helically oriented tines into the anatomic tissue further comprises the step of rotating the annular ring and axially compressing the annular ring and the tubular graft to the anatomic tissue (col. 49, ll. 28-63).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Shalev et al. (U.S. Patent Application Publication No. 20100063575; hereinafter “Shalev”).
Regarding claim 11, the method of Griffin discloses the invention substantially as claimed, except for providing the tissue connection device with a procoagulation pharmacologically active agent.
Shalev, a reference in the vascular treatment field of endeavor, teaches providing graft with collagen or procoagulation materials to prevent leakage of blood during use (para. [0005]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Griffin such that the step of attaching a tissue connection device further comprises the step of providing the tissue connection device having a procoagulation pharmacologically active agent disposed on at least a some of the plurality tines, in view of Shalev, in order to prevent blood or other bodily fluid from leaking where the tines penetrate anatomic tissue.
Allowable Subject Matter
Claim 4 is 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.
Claims 13-17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 4 recites inter alia “the step of embedding the plurality of helically oriented tines into the anatomic tissue further comprises the step of engaging axial projections extending from a proximal end of the annular ring and rotating the annular ring.”
Claim 13 recites inter alia “providing an assembly configured for end-to-side connection, comprising . . . the annular ring having a plurality of helically oriented tines projecting axially from a distal end of the annular ring and a plurality of tine ring engagement members positioned at a proximal end of the annular ring.”
The prior art does not disclose or suggest a method for making an end-to-side anastomosis including an annular ring having helically oriented tines and proximal axial projections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771