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 01/13/2026. Claims 1-14 are pending. Claim 1 is independent. Claim 9 is withdrawn from consideration. Claims 13 and 14 have been newly added. Newly added claim 13 is withdrawn for the reason(s) below.
Election/Restrictions
Newly submitted claim 13 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 13 is directed to the non-elected species, Species B (Fig. 7) by reciting “at least two radiolabels (43) integral with the first face of the intermediate segment and positioned respectively at the axial ends of the intermediate segment (23).”
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 13 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Currently, none of the claim limitations are treated under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites the limitation “a radiolabel (43) integral with the first segment (21), a second radiolabel and a third radiolabel integral with the first and second segments (22, 23) respectively, the first radiolabel and the second radiolabel being aligned along the axis of the prosthesis, the first radiolabel being angularly offset from the second radiolabel and the third radiolabel.” The claim language in claim 11 contradicts with the claim language in claim 1. First, numeral “23” is the intermediate segment (not the second segment) and numeral “22” is the second segment (not the first segment) as claimed in claim 1. Secondly, the specification does not disclose a second radiolabel integral with the first segment. Furthermore, the specification does not describe that the radiolabel (or first radiolabel) integral with the first segment (21) is angularly offset from the second radiolabel (42). Therefore, claim 11 contains new matter.
Claim 14 recites the limitation “the radiolabel being provided only on said first face and being absent from the second face of the intermediate segment and from the first and second segments” which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. First the limitation “the radiolabel being provided only on said first face and being absent from the second face of the intermediate segment and from the first and second segments” is a negative limitation. According to MPEP 2173.05(i), “(a}ny negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). In describing alternative features, the applicant need not articulate advantages or disadvantages of each feature in order to later exclude the alternative features. See Inphi Corporation v. Netlist, Inc., 805 F.3d 1350, 1356-57, 116 USPQ2d 2006, 2010-11 (Fed. Cir. 2015). The mere absence of a positive recitation is not basis for an exclusion. However, a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). "Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.' ... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172). Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. See MPEP § 2163 - § 2163.07(b) for a discussion of the written description requirement of 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.” The specification does not describe the radiolabel is absent from the second face of the intermediate segment and from the first and second segments. Therefore, the limitation “the radiolabel being provided only on said first face and being absent from the second face of the intermediate segment and from the first and second segments” is considered as new matter.
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.
Claim 11 is 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 11 recites the limitation "the first radiolabel" in lines 3-4 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, “the first radiolabel” is considered as the radiolabel integral with the first segment.
Claim 11 recites the limitation "the axis" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “a radiolabel (43) integral with the first segment (21), a second radiolabel and a third radiolabel integral with the first and second segments (22, 23) respectively, the first radiolabel and the second radiolabel being aligned along the axis of the prosthesis, the first radiolabel being angularly offset from the second radiolabel and the third radiolabel.” The claim language in claim 11 contradicts with the claim language in claim 1. First, numeral “23” is the intermediate segment (not the second segment) and numeral “22” is the second segment (not the first segment) as claimed in claim 1. Secondly, the specification does not disclose a second radiolabel integral with the first segment. Furthermore, the specification does not describe that the radiolabel (or first radiolabel) integral with the first segment (21) is angularly offset from the second radiolabel (42). For the purpose of examination, the limitation “a radiolabel (43) integral with the first segment (21), a second radiolabel and a third radiolabel integral with the first and second segments (22, 23) respectively, the first radiolabel and the second radiolabel being aligned along the axis of the prosthesis, the first radiolabel being angularly offset from the second radiolabel and the third radiolabel” is interpreted to be “a first radiolabel (43) integral with the first segment (21), a second radiolabel and a third radiolabel integral with the intermediate segments (22, 23) respectively, the first radiolabel and the second radiolabel being aligned along the axis of the prosthesis, the third radiolabel being angularly offset from the first radiolabel and the second radiolabel.”
The art rejection(s) below is/are made as best understood by the examiner because of the 35 USC 112 issue(s) stated above.
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) 1, 4-6, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hidari (US Pub. No.: 2020/0214826) in view of Malhe (US Pub. No.: 2016/0270900).
Regarding claims 1, 4-6, and 12, Hidari discloses [claim 1] a vascular prosthesis (30, Figs. 2A-2C) or 30b, Figs. 7A-7C, the vascular prosthesis is fully capable for endobypass pending a future anastomosis), characterized in that it has: - a wall (wall defined by the graft 33 or 33b, Fig. 2A or 7A) forming a conduit between first and second orifices (proximal and distal opening of the vascular prosthesis, Fig. 2A), respectively positioned at first (the graft segment covering 321 and 322) and second segments (the graft segment covering 324 and 325) of the wall; - a first stent (321, Fig. 2A) integral with the wall and encircling the wall at the first segment; - a second stent (324, Fig. 2A) integral with the wall and encircling the wall at the second segment; - the wall comprising an intermediate segment (middle segment between the first and second segment with the height/length only covering the stent 323, Fig. 2A and see Figure below) and second faces (P face/region, Figs. 3C or Figs. 7A-7C) extending over respective angular portions, wherein the intermediate segment forms continuity between the first and second segments by extending the intermediate segment from the first segment to the second segment (Figs. 2A and 2B and see Fig below, the intermediate segment forms continuity between the first and second segments by extending the intermediate segment from the first segment to the second segment), intermediate segment is fully capable to ensure the blood flow through the conduit (Fig. 2A); - a third stent (323, Figs. 2A and 3A-3C) integral with the first face of the intermediate segment of the wall, the third stent extending over the entire angular portion of the first face (Figs. 2A and 3A-3C or Figs. 7A-7C), the second face of the intermediate segment being without a stent (Figs. 2A and 3A-3C or Figs. 7A-7C); [claim 4] wherein said third stent extends over the entire height of the first face (Figs. 2A and 3A-3C or Figs. 7A-7C); [claim 5] wherein said third stent passes through a cross-section in the intermediate segment at least 4 times (Figs. 2A and 3A-3C or Figs. 7A-7C); [claim 6] wherein the angular portion of the second face extends over an angle of between 900 and 2000 (Para. [0067], when the angle of P region is 1800, the region is Q is also 1800); and [claim 12] wherein the wall has a circular cylindrical shape (Figs. 2A and 3A-3C or Figs. 7A-7C). However, Hidari does not specifically disclose that the wall is leaktight such that the intermediate segment is configured to ensure the absence of endoleaks therein.
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Malhe teaches, in the same field of endeavor (vascular prosthesis), a vascular prosthesis comprising: a wall (wall formed by sheath/graft material 2, Fig. 11) that is leaktight (Para. [0054]).
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 wall of the vascular prosthesis of Hidari to be leaktight as taught by Malhe in order to obtain the advantage of preventing leakage and/or restoring the blood flow through the lumen of the vascular prosthesis (Malhe, Paras. [0054] and [0068]). In the modified invention, the intermediate segment is fully capable to ensure the absence of endoleaks therein because the wall of the vascular prosthesis is leaktight and the purpose of the branching portion (35 of Hidari) is for connecting to a side branch stented graft for delivering blood to a second blood vessel.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hidari (US Pub. No.: 2020/0214826) in view of Malhe (US Pub. No.: 2016/0270900) as applied to claim 1 above, and further in view of Matsutani et al. (US Pub. No.: 2002/0013617).
Regarding claim 2, Hidari in view of Malhe discloses all the limitations of claim 1 as taught above. However, neither Hidari nor Malhe discloses that the height of the first and second segments extend over at least 20 mm, preferably 40 mm, respectively.
Matsutani teaches, in the same field of endeavor (vascular prosthesis), the height of a first and second segments (e.g. distal segment with two zig-zag stent rings and proximal with two zig-zag stent rings) of a vascular prosthesis (the prosthesis show in Fig. 5) extends over at least 20 mm (Para. [0047]).
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 first and second segments of the vascular prosthesis of Hidari in view of Malhe to be at least 20 mm as taught by Matsutani, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Regarding claim 3, Hidari in view of Malhe discloses all the limitations of claim 1 as taught above. However, neither Hidari nor Malhe discloses that the height of the intermediate segment extends over at least 20 mm.
Matsutani teaches, in the same field of endeavor (vascular prosthesis), the height of an intermediate segment (the center segment with a zig-zag stent ring) of a vascular prosthesis (the prosthesis show in Fig. 5) extends over at least 20 mm (Para. [0047], 25 mm).
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 intermediate segment of the vascular prosthesis of Hidari in view of Malhe to be at least 20 mm as taught by Matsutani, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hidari (US Pub. No.: 2020/0214826) in view of Malhe (US Pub. No.: 2016/0270900) as applied to claim 1 above, and further in view of Hartley (US Pub. No.: 2006/0095118).
Regarding claim 7, Hidari in view of Malhe discloses all the limitations of claim 1 as taught above. However, neither Hidari nor Malhe discloses that the wall has a diameter of between 8 and 35 mm.
Hartley teaches, in the same field of endeavor (vascular prosthesis), a wall of a vascular prosthesis (the wall of 3, Fig. 1 and 4A) has a diameter of between 8 and 35 mm (Para. [0044], e.g. 12 mm).
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 diameter of the wall of the vascular prosthesis of Hidari in view of Malhe to be between 8 and 35 mm, such as 12 mm, as taught by Hartley, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Regarding claim 8, Hidari in view of Malhe discloses all the limitations of claim 1 as taught above. However, neither Hidari nor Malhe discloses that the height of the wall is less than 200 mm.
Hartley teaches, in the same field of endeavor (vascular prosthesis), the height of a wall of a vascular prosthesis (the wall of 3, Fig. 1 and 4A) is less than 200 mm (Para. [0044], e.g. 103 mm).
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 height of the wall of the vascular prosthesis of Hidari in view of Malhe to be less than 200 mm, such as 103 mm, as taught by Hartley, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Claim(s) 10, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer et al. (US Pub. No.: 2008/0114445) in view of Malhe (US Pub. No.: 2016/0270900).
Regarding claim 10, Melsheimer discloses a vascular prosthesis (132, Figs. 10 and 11 and Paras. [0070] and [0075], stent graft is fully capable to serve for endobypass pending a future anastomosis) for endobypass pending a future anastomosis, characterized in that it has: - a wall (134, Fig. 10) forming a conduit between first and second orifices (orifices at 136 and 138, Figs. 10 and 11), respectively positioned at first and second segments (see Figure below) of the wall; - a first stent (a stent in the first segment, Fig. 10) integral with the wall and encircling the wall at the first segment; - a second stent (a stent in the second segment) integral with the wall and encircling the wall at the second segment; - the wall comprising an intermediate segment (see Figure below) between the first and second segments, the intermediate segment has first and second faces (see Figure below, the indicated first face is at least half the circumference of the stent graft and has a stent on it. The indicated second face extends into the page of the drawing shown in Fig. 10. It has a portion of the radiolabel and does not include any stent portions.) extending over respective angular portions, wherein the intermediate segment forms continuity between the first and second segments by extending the intermediate segment from the first segment to the second segment (see Figure below), - a third stent (a stent in the first face of the intermediate segment, see Figure below) integral with the first face of the intermediate segment of the wall, the third stent extending over the entire angular portion of the first face (see Figure below), wherein the third stent passes through a cross-section in the intermediate segment at least 4 times (see Figure below and Figs. 10 and 11, the third stent passes through a cross-section in the intermediate segment at least 4 times), the second face of the intermediate segment being without a stent (the indicated second face has no stent); a radiolabel (see Figure below) integral with the first face of the intermediate segment, the radiolabel being provided at the boundary between said first face and said second face (see Figure below). However, Melsheimer does not specifically disclose that the wall is leaktight such that the intermediate segment is configured to ensure the absence of endoleaks therein.
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Malhe teaches, in the same field of endeavor (vascular prosthesis), a vascular prosthesis comprising: a wall (wall formed by sheath/graft material 2, Fig. 11) that is leaktight (Para. [0054]).
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 wall of the vascular prosthesis of Melsheimer to be leaktight as taught by Malhe in order to obtain the advantage of preventing leakage and/or restoring the blood flow through the lumen of the vascular prosthesis (Malhe, Paras. [0054] and [0068]). In the modified invention, the intermediate segment is fully capable to ensure the absence of endoleaks therein because the wall of the vascular prosthesis is leaktight.
Regarding claim 11, Melsheimer discloses a vascular prosthesis (132, Figs. 10 and 11 and Paras. [0070] and [0075], stent graft is fully capable to serve for endobypass pending a future anastomosis) for endobypass pending a future anastomosis, characterized in that it has: - a wall (134, Fig. 10) forming a conduit between first and second orifices (orifices at 136 and 138, Figs. 10 and 11), respectively positioned at first and second segments (see Figure below) of the wall; - a first stent (a stent in the first segment, Fig. 10) integral with the wall and encircling the wall at the first segment; - a second stent (a stent in the second segment) integral with the wall and encircling the wall at the second segment; - the wall comprising an intermediate segment (see Figure below) between the first and second segments, the intermediate segment has first and second faces (see Figure below, the indicated first face is at least half the circumference of the stent graft and has a stent on it. The indicated second face has no stent.) extending over respective angular portions, wherein the intermediate segment forms continuity between the first and second segments by extending the intermediate segment from the first segment to the second segment (see Figure below), - a third stent (a stent in the intermediate segment, see Figure below) integral with the first face of the intermediate segment of the wall, the third stent extending over the entire angular portion of the first face (see Figure below), wherein the third stent passes through a cross-section in the intermediate segment at least 4 times (see Figure below and Figs. 10 and 11, the third stent passes through a cross-section in the intermediate segment at least 4 times), the second face of the intermediate segment being without a stent (the indicated second face has no stent); a first radiolabel (see Figure below) integral with the first segment, a second radiolabel (see Figure below) and a third radiolabel integral with the second and intermediate segments respectively, the first radiolabel and the second radiolabel being aligned along the axis of the prosthesis, the third radiolabel being angularly offset from the first radiolabel and the second radiolabel (see Figure below). However, Melsheimer does not specifically disclose that the wall is leaktight such that the intermediate segment is configured to ensure the absence of endoleaks therein.
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Malhe teaches, in the same field of endeavor (vascular prosthesis), a vascular prosthesis comprising: a wall (wall formed by sheath/graft material 2, Fig. 11) that is leaktight (Para. [0054]).
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 wall of the vascular prosthesis of Melsheimer to be leaktight as taught by Malhe in order to obtain the advantage of preventing leakage and/or restoring the blood flow through the lumen of the vascular prosthesis (Malhe, Paras. [0054] and [0068]). In the modified invention, the intermediate segment is fully capable to ensure the absence of endoleaks therein because the wall of the vascular prosthesis is leaktight.
Regarding claim 14, Melsheimer discloses a vascular prosthesis (132, Figs. 10 and 11 and Paras. [0070] and [0075], stent graft is fully capable to serve for endobypass pending a future anastomosis) for endobypass pending a future anastomosis, characterized in that it has: - a wall (134, Fig. 10) forming a conduit between first and second orifices (orifices at 136 and 138, Figs. 10 and 11), respectively positioned at first and second segments (see Figure below) of the wall; - a first stent (a stent in the first segment, Fig. 10) integral with the wall and encircling the wall at the first segment; - a second stent (a stent in the second segment) integral with the wall and encircling the wall at the second segment; - the wall comprising an intermediate segment (see Figure below) between the first and second segments, the intermediate segment has first and second faces (see Figure below, the indicated first face is at least half the circumference of the stent graft and has a stent on it. The indicated second face extends into the page of the drawing shown in Fig. 10. It has a portion of the radiolabel and does not include any stent portions.) extending over respective angular portions, wherein the intermediate segment forms continuity between the first and second segments by extending the intermediate segment from the first segment to the second segment (see Figure below), - a third stent (a stent in the first face of the intermediate segment, see Figure below) integral with the first face of the intermediate segment of the wall, the third stent extending over the entire angular portion of the first face (see Figure below), wherein the third stent passes through a cross-section in the intermediate segment at least 4 times (see Figure below and Figs. 10 and 11, the third stent passes through a cross-section in the intermediate segment at least 4 times), the second face of the intermediate segment being without a stent (the indicated second face has no stent); a radiolabel (see Figure below) integral with the first face of the intermediate segment, the radiolabel being provided only on said first face and being absent from the second face of the intermediate segment and from the first and second segments (see Figure below, the radiolabel is provided only on said first face and being absent from the second face of the intermediate segment and from the first and second segments). However, Melsheimer does not specifically disclose that the wall is leaktight such that the intermediate segment is configured to ensure the absence of endoleaks therein.
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Malhe teaches, in the same field of endeavor (vascular prosthesis), a vascular prosthesis comprising: a wall (wall formed by sheath/graft material 2, Fig. 11) that is leaktight (Para. [0054]).
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 wall of the vascular prosthesis of Melsheimer to be leaktight as taught by Malhe in order to obtain the advantage of preventing leakage and/or restoring the blood flow through the lumen of the vascular prosthesis (Malhe, Paras. [0054] and [0068]). In the modified invention, the intermediate segment is fully capable to ensure the absence of endoleaks therein because the wall of the vascular prosthesis is leaktight.
Response to Arguments
In response to the argument regarding the claim objection on page 4 of the remark, the objection to claim 1 made in the most recent office action has been withdrawn in light of the amendment.
In response to the argument(s) on pages 4-7 of the remarks, Hidari’s vascular prosthesis 30 is fully capable for endobypass pending a future anastomosis because it is a stent graft. Although Hidari is silent that the wall of the stent graft 30 has a leaktight wall, it is highly desirable for a stent graft include a leaktight wall as Malhe discloses that. the advantage of a leaktight wall is to prevent leakage and/or restoring the blood flow through the lumen of the vascular prosthesis (Malhe, Paras. [0054] and [0068]). The purpose of opening 37 is for connecting to a side branch stented graft for delivering blood to a second blood vessel. The function of hole 37 for transporting blood through it in the similar way as the distal opening and proximal opening. In the modified invention, the wall of the stent graft itself is leaktight while allowing the hole 37 to transport blood which is not considered as endoleak. It is known in the art or once of ordinary skill in the art would know that it is highly undesirable to have a stent graft wall to be leaky.
The intermediate segment forms continuity between the first and second segments by extending the intermediate segment from the first segment to the second segment (Figs. 2A and 2B and see Fig below, the intermediate segment forms continuity between the first and second segments by extending the intermediate segment from the first segment to the second segment). The present of the through hole 36 does not make that the intermediate segment to be not in continuity between the first and second segments. The intermediate segment forms continuity between the first and second segments the intermediate segment extends from the first segment to the second segment.
Applicant’s arguments with respect to claim(s) 10, 11, and 14 have been considered but are moot in view of new ground(s) of rejection. See new grounds of rejection above.
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.
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/JING RUI OU/Primary Examiner, Art Unit 3771