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 .
This action is in response to the amendment filed on 08/19/2025. Claims 1-7, 11, 13-15, and 28-32 are pending. Claims 1, 11, and 28 are independent.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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 § 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 1-7 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 1 recites the limitation "the tubular section" in line 6 of the claim. There is insufficient antecedent basis for this limitation in the claim.
The art rejection(s) below is/are made as best understood by the examiner’s because of the 35 U.S.C. 112 issue(s) stated above.
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) 1-7, 11, 13, 14, and 28-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carson (US Pub. No.: 2005/0192604).
Regarding claims 1-7, Carson discloses [claim 1] a tubular conduit (10, Figs. 1A and 3A-3D) for end-to-side connection with an anatomical structure, comprising a tubular graft (18, Fig. 1A and Para. [0066], 18 extends distally and terminates at 16) having a central lumen (lumen along 18, Figs. 1A and 3A-3D) and a terminal skirt (16, Figs. 1A and 3A-3D) unitary and integral with a distal end of the tubular graft and extending about an entire circumference of the distal end of the tubular graft (Figs. 1A and 3A-3D), wherein the terminal skirt has substantially a saddle-shape or is configured to conform to substantially a saddle-shape (Figs. 1A and 3A-3D), the terminal skirt projecting radially outward from a central longitudinal axis of the tubular section/graft (Figs. 1A and 3A-3D); [claim 2] a stent (14, Fig. 1A and 3A-3D) operably coupled to the tubular graft, the stent having a terminal circumferential flange section (flange / radially extended section at the distal end of 14, Figs. 1A and 3A-3D) that has a substantially saddle-shape (Figs. 1A and 3A-3D); [claim 3] wherein the stent is at least partially embedded within walls of the tubular conduit (Fig. 3C, the stent is at least partially embedded within walls of the tubular conduit forming the grooves); [claim 4] wherein the stent is operably coupled to a luminal surface of the tubular conduit and the terminal flange bears upon the terminal skirt of the tubular conduit (Figs. 3B-3D and Para. [0071]); [claim 5] at least one reinforcing member (20, Fig. 1A) joined to an exterior wall surface of the tubular conduit; [claim 6] wherein the terminal skirt of the tubular graft and the terminal flange of the stent are nested with each other across a wall surface of the anatomical structure (Figs. 3B-3D and Para. [0071]); [claim 7] at least one reinforcing member (20, Fig. 1A and Para. [0067]; alternatively, the reinforcing member 56 as shown in Fig. 4A, Para. [0072]) joined with the tubular graft, the at least one reinforcing member being configured to maintain luminal patency of the tubular graft when the tubular graft is bent up to 90 degrees away from its central longitudinal axis (Para. [0067] or [0072]).
Regarding claims 11, 13, and 14, Carson discloses [claim 11] a tubular graft assembly configured to be attached to a side of a tubular anatomical structure, comprising: a graft conduit (18, Fig. 1A and Para. [0066], 18 extends distally and terminates at 16) having a distal end skirt (16, Figs. 1A and 3A-3D) unitary and integral with the distal end of the graft conduit and extending about an entire circumferential axis of the distal end of the graft conduit (Figs. 1A and 3A-3D); a stent (14, Fig. 1A and 3A-3D) having a tubular portion and a flange portion circumferentially extending from a distal end of the tubular portion; wherein in an installed state the tubular portion of the stent is disposed within the graft conduit, the distal end skirt is engaged against an outer wall surface of the tubular anatomical structure, the flange portion of the stent is extended distally beyond the distal end skirt, and the flange portion of the stent engages against the inner wall surface of the tubular anatomical structure (Figs 3B-3D); and wherein in the installed state at least a portion of the tubular anatomical structure is compressed between the distal end skirt and the flange portion of the stent (Figs 3B-3D); [claim 13] wherein the tubular portion and the flange portion of the stent are unitary (Figs 3B-3D); and [claim 14] wherein the flange portion of the stent is substantially saddle-shaped (Fig. 1A and 3A-3D).
Regarding claims 28-32, Carson discloses [claim 28] end-to-side vascular anastomosis device, comprising: a tubular graft (18, Fig. 1A and Para. [0066], 18 extends distally and terminates at 16) having a central lumen (lumen along 18, Figs. 1A and 3A-3D) and a terminal skirt (16, Figs. 1A and 3A-3D) integral with the tubular graft and projecting radially outward from a distal end of the tubular graft and extending about at least a substantial circumferential axis of the tubular graft (16, Figs. 1A and 3A-3D), wherein the terminal skirt has substantially a saddle-shape or is configured to conform to substantially a saddle-shape (16, Figs. 1A and 3A-3D), and a stent (14, Fig. 1A and 3A-3D) operably coupled to the tubular graft, the stent having a terminal flange section (flange / radially extended section at the distal end of 14, Figs. 1A and 3A-3D) that extends about at least a substantial circumferential axis of the stent and has a substantially saddle-shape (Figs. 1A and 3A-3D), wherein the stent and the tubular graft are configured to nest on opposing wall surfaces of a blood vessel (Figs. 3B-3D); [claim 29] wherein the stent is at least partially embedded within walls of the tubular graft (Fig. 3C, the stent is at least partially embedded within walls of the tubular conduit forming the grooves); [claim 30] wherein the stent is operably coupled to a luminal surface of the tubular conduit and the terminal flange bears upon the terminal skirt of the tubular graft (Figs. 3B-3D); [claim 31] at least one reinforcing member (20, Fig. 1A and Para. [0067]) joined to an exterior wall surface of the tubular graft; [claim 32] wherein the at least one reinforcing member is configured to maintain luminal patency of the tubular graft when the tubular graft is bent up to 90 degrees away from its central longitudinal axis (Para. [0067] and also see Fig. 4A as an example. The at least one reinforcing member is configured to maintain luminal patency of the tubular graft on the portion of the graft it is supporting when the tubular graft is bent up to 90 degrees away from its central longitudinal axis).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carson (US Pub. No.: 2005/0192604) as applied to claim 11 above, and further in view of Asfora (US Pub. No.: 2014/0343582).
Regarding claim 15, Carson discloses all the limitations of claim 11 as taught above but fails to disclose an external annular support having a plurality of openings, wherein in the installed state the external annular support is disposed around the distal end skirt and engages the distal end skirt.
Asfora teaches, in the same field of endeavor (tubular graft assembly), an external annular support (1000, Fig. 10; alternatively, 3130, Fig. 31) having a plurality of openings (see Figure below, the openings are similar to the openings shown in Figs. 10 and 11), wherein in the installed state the external annular support is disposed around the distal end skirt and engages the distal end skirt (Paras. [0122]-[0123] and the installed state is similar to what is shown in Fig. 26).
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Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the tubular graft assembly of Carson to include an external annular support having a plurality of openings, wherein in the installed state the external annular support is disposed around the distal end skirt and engages the distal end skirt as taught by Asfora in order to obtain the advantage of providing a leak-proof seal between the graft vessel to the main vessel (Asfora, Paras. [0054] and [0056]).
Response to Arguments
In response to the argument(s) on pages 5-12 of the remarks, all the rejections made in the most recent office action have been withdrawn in light of the amendment.
Applicant’s arguments with respect to claim(s) 1-7, 11, 13-15, and 28-32 have been considered but are moot in view of new ground(s) of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/ Primary Examiner, Art Unit 3771