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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character;
“1a” has been used to designate both proximal landing zone ¶[0061] and partially deployed balloon expandable device ¶ [0066].
“1b” has been used to designate both distal landing zone .
“2” has been used to designate both aneurysm sac ¶[0060] and barb ¶ [0062].
“4” has been used to designate both overlap zone, umbrella shaped end [0080], component ¶ [0080] and plug ¶ [0081].
“5” has been used to designate both second component ¶ [0080], central lumen ¶ [0082], in fig. 4A, it appears to be a balloon and in fig 6A it is unclear what it is pointing to.
“6” has been used to designate both inferior mesenteric artery ¶ [0061], filter ¶ [0068], cylindrical plug ¶ [0083] and in figs. 6a-6C it appears to be a flange.
“7” has been used to designate both lumbar arteries ¶ [0061] and reverse barbs [0068].
“8” has been used to designate both wire release mechanism ¶ [0068] and first component ¶ [0070].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 8b and 10.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 8 (wire release mechanism ¶ [0068]).
The drawings are objected to because figs. 7-9D need labels for the elements being depicted.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 4, 10-11 and 14-18 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 4 recites the limitation "the cylindrical portion" in line 2. There is insufficient antecedent basis for this limitation in the claim. Dependent claims 10-11 are likewise rejected.
Claims 10 and 11 recite “a plurality of filters” in lines 1-2, it is unclear if this is the same plurality of filters in claim 4 or a separate and additional plurality of filters.
Claim 10 recites the filters “may be flat … and may be integrated” in line 2. The use of the word ‘may’ makes it unclear if the limitation is required or just an option.
Claim 14 recites the limitation "the plug" in line 1. There is insufficient antecedent basis for this limitation in the claim. Dependent claims 15-18 are likewise rejected.
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) 1-4, 6-7, 9-12 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwartz (US 2020/0085600 A1).
Regarding claim 1, Schwartz teaches a device (20, device, fig. 6A) configured to be implanted to create a temporary or permanent connection between two hollow structures, comprising:
a stent (22, body, fig. 6A) configured to be disposed between an aortic or large vessel aneurysm sac and a large adjacent vein. The phrase “a stent configured to be disposed between an aortic or large vessel aneurysm sac and a large adjacent vein ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the body is considered to be capable of being disposed between an aortic or large vessel aneurysm sac and a large adjacent vein.
Regarding claim 2, Schwartz further teaches the stent is either balloon expandable or self-expandable (¶ [0134]).
Regarding claim 3, Schwartz further teaches the stent is either an open cell stent without covering (¶ [0142]), or the stent is partially or fully covered with fabric or film (¶ [0146]).
Regarding claim 4, Schwartz further teaches the stent includes one or a plurality of filters at one or both ends thereof or within the cylindrical portion thereof (¶ [0185-0186]).
Regarding claim 6, Schwartz further teaches one or both ends of the stent are flanged (26, 28, anchoring features, fig. 6A).
Regarding claim 7, Schwartz further teaches a conical or umbrella shaped end of the stent (“flares”, ¶ [0156]) is attachable to either end or both ends of the aortic sac or the venous side. The phrase “a conical or umbrella shaped end of the stent is attachable to either end or both ends of the aortic sac or the venous side” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the flares are considered to be capable of attaching to either end or both ends of the aortic sac or the venous side.
Regarding claim 9, Schwartz further teaches at least a portion of the stent has at least one of a textured surface, a plurality of barb rows, a plurality of donuts, toroids, or undulations (¶ [0156]).
Regarding claim 10, Schwartz further teaches the one or a plurality of filters may be flat (56, filter, fig. 14), oriented antegrade or retrograde to flow (¶ [0186]), and may be integrated or detachable (56, filter, fig. 14).
Regarding claim 11, Schwartz further teaches the one or a plurality of filters is open cell, wire mesh or partially or completely fabric covered (¶ [0188]).
Regarding claim 12, Schwartz further teaches the stent includes at least one conical, tapered, or flared end (¶ [0156]) to facilitate future access to the aneurysm sac. The phrase “the stent includes at least one conical, tapered, or flared end to facilitate future access to the aneurysm sac ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the flared end is considered to be capable of facilitating future access to the aneurysm sac.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz.
Regarding claim 5, a first embodiment of Schwartz fails to teach two or more stents. However, a second embodiment of Schwartz teaches two or more stents (662, first stent, 664, second stent, fig. 87) that can be joined to bridge different distances between the aneurysm sac and the vein (¶ [0180]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the first embodiment of Schwartz to include two or more stents as taught by a second embodiment of Schwartz in order to extend the total length of the shunt (¶ [0180, Schwartz).
Regarding claim 8, a first embodiment of Schwartz fails to teach a valve. However, a 3rd embodiment of Schwartz teaches a flow-reducing valve or a plurality of valves is disposed at one or both ends of the stent, or within the stent (394, 369, valve, fig. 60). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the first embodiment of Schwartz to include a valve as taught by a 3rd embodiment of Schwartz in order to provide reduced PA pulse pressure, reduced mean PA pressure, and still maintain cardiac output (¶ [0241], Schwartz).
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz in view of Faul (US 2012/0010556 A1).
Regarding claim 13, Schwartz fails to teach a plug. However, Faul teaches a shunt device implanted between two hollow structures that includes a plug (630, leaves, fig. 6) to reduce flow in the arterio-venous connection (¶ [0062]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Schwartz to include a plug as taught by Faul in order to change the cross section area of the lumen (¶ [0062]).
Regarding claim 14, Schwartz fails to teach a plug configured to stop the flow. However, Faul further teaches the plug is configured to stop the flow in the arterio-venous connection (¶ [0063]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Schwartz to include the plug is configured to stop the flow as taught by Faul in order to change the cross section area of the lumen (¶ [0062]).
Regarding claim 15, Schwartz fails to teach the plug includes and funnel or conical shape. However, Faul further teaches a funnel or conical shape on one or both sides (fig. 6), tapering to a wire-accessible central lumen. The phrase “the plug . . . tapering to a wire-accessible central lumen” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the plug is considered to be capable of being wire-accessible. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Schwartz to include the plug includes a funnel or conical shape as taught by Faul in order to change the cross section area of the lumen (¶ [0062]).
Regarding claim 16, Schwartz further teaches the stent is composed of metal (¶ [0156]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz in view of Faul as applied to claim 16 above, and further in view of Burnside (US 6,626,939 B1).
Regarding claim 17, Schwartz and Faul fails to teach the material is dissolvable. However, Burnside discloses a stent that teaches the use of dissolvable materials (col 2 line 57 – col 3 line 34). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Schwartz and Faul to be dissolvable as taught by Burnside since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 18, Schwartz and Faul fails to teach the material is fully dissolvable. However, Burnside discloses a stent that teaches the use of a fully dissolvable materials (col 2 line 57 – col 3 line 34, fig. 26). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Schwartz and Faul to use a material that is fully dissolvable as taught by Burnside since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571) 272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799