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)(5) because they include the following reference character(s) not mentioned in the description: 306, 326.
In Figure 6, reference character 203 is pointing at the 3rd circle not the exterior contour.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Claim 13 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 13 recites “The braided stent of claim 9” in line 1. However, claim 1 (which claim 9 depends on) does not describe the stent as “braided”. It is unclear if claim 13 is intended to be dependent on claim 9 and independent claim 1 or dependent on independent claim 10. The Examiner is examining as though claim 13 is dependent on claim 9 and recommends deleting “braided” from the preamble.
Claim 13 recites “a first inner shoulder in lines 1-2. However, claim 7 (claim 13 is dependent from) recites “a first inner shoulder” in line 3. It is unclear if this is the same first inner shoulder or if they are separate and distinct. For examination, the Examiner interprets them to be the same first inner shoulder.
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) 1-3, 6-10 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eller (US 2018/0263797 A1) in view of Howard (US 2018/0168658 A1)
Regarding claim 1, Eller teaches a stent (100, fig. 1) comprising:
a hollow body (101, fig. 1) comprising:
an interior space (102);
an exterior contour (103, fig. 1);
a first flared end (120, fig. 1), a second flared end (130, fig. 1), and a middle region that extends between the first flared end and the second flared end (110, fig. 1).
Eller fails to teach the middle region comprises a concave, curvilinear shape. However, Howard teaches a stent that includes the middle region comprises a concave, curvilinear shape (fig. 5). 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 middle region of Eller to include the middle region comprises a concave, curvilinear shape as taught by Howard in order to prevent the drainage stent from migrating once it is has been deployed (¶ [0081], Howard).
Regarding claim 2, Eller further teaches a first crest extending from the middle region (124, fig. 5); a first opening (128, fig. 5); and a first outer taper extending between the first crest and the first opening (126, fig. 5).
Regarding claim 3, Eller further teaches the first flared end further comprises a first inner shoulder extending between the middle region and the first crest (122, fig. 5).
Regarding claim 6, Eller further teaches the hollow body further comprises a longitudinal plane that bisects the hollow body along a longitudinal axis of the hollow body (fig. 1).
Eller fails to teach a first circle defined at least in part by the middle region. However, Howard further teaches wherein the longitudinal plane comprises a first circle defined at least in part by the middle region (see annotated fig. 5, below), and wherein a profile of at least a portion of the middle region circumscribes a first arc of the first circle (see annotated fig. 5, below). 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 middle region of Eller to include a first circle defined at least in part by the middle region as taught by Howard in order to prevent the drainage stent from migrating once it is has been deployed.
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Regarding claim 7, Eller further teaches wherein the longitudinal plane further comprises a second circle defined at least in part by the first crest (see annotated fig. 5, below), a third circle defined at least in part by the first outer taper (see annotated fig. 5, below), and a fourth circle defined at least in part by a first inner shoulder (see annotated fig. 5, below).
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Regarding claim 8, Eller further teaches wherein a profile of at least a portion of the first crest circumscribes a second arc of the second circle (see annotated fig. 5, below), a profile of at least a portion of the first outer taper circumscribes a third arc of the third circle (see annotated fig. 5, below), and a profile of at least a portion of the first inner shoulder circumscribes a fourth arc of the fourth circle (see annotated fig. 5, below).
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Regarding claim 9, Eller further teaches the longitudinal plane further comprises a fifth circle defined at least in part by the first inner shoulder (see annotated fig. 5, below), a profile of a portion of the first inner shoulder circumscribing a fifth arc of the fifth circle (see annotated fig. 5, below).
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Regarding claim 10, Eller teaches a braided stent (100, fig. 1, ¶ [0019]), comprising:
a hollow body (101, fig. 1) comprising:
an interior space (102);
an exterior contour (103, fig. 1);
a first flared end (120, fig. 1), a second flared end (130, fig. 1), and a middle region that extends between the first flared end and the second flared end (110, fig. 1).
wherein the first flared end comprises a first crest extending from the middle region (124, fig. 5); a first opening (128, fig. 5); and a first outer taper extending between the first crest and the first opening (126, fig. 5).
Eller fails to teach the middle region comprises a concave, curvilinear shape. However, Howard teaches a stent that includes the middle region comprises a concave, curvilinear shape (fig. 5). 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 middle region of Eller to include the middle region comprises a concave, curvilinear shape as taught by Howard in order to prevent the drainage stent from migrating once it is has been deployed (¶ [0081], Howard).
Regarding claim 13, Eller further teaches the braided stent of claim 9, wherein the first flared end further comprises the first inner shoulder extending between the middle region and the first crest (122, fig. 5).
Regarding claim 14, Eller further teaches wherein the hollow body further comprises a longitudinal plane that bisects the hollow body along a longitudinal axis of the hollow body (fig. 1), the longitudinal plane comprising: a second circle defined at least in part by the first crest (see annotated fig. 5, below), a profile of at least a portion of the first crest circumscribing a second arc of the second circle (see annotated fig. 5, below); and a third circle defined at least in part by the first outer taper (see annotated fig. 5, below), a profile of at least a portion of the first outer taper circumscribing a third arc of the third circle (see annotated fig. 5, below).
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Eller fails to teach a first circle defined at least in part by the middle region. However, Howard further teaches a first circle defined at least in part by the middle region (see annotated fig. 5, below), a profile of at least a portion of the middle region circumscribing a first arc of the first circle (see annotated fig. 5, below). 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 middle region of Eller to include a first circle defined at least in part by the middle region as taught by Howard in order to prevent the drainage stent from migrating once it is has been deployed (¶ [0081], Howard).
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Regarding claim 15, Eller further teaches wherein the longitudinal plane further comprises one or more circles (see annotated fig. 5, below) defined at least in part by a first inner shoulder (122, fig. 5), one or more profiles of at least a portion of the first inner shoulder circumscribing one or more arcs of the one or more circles defined at least in part by the first inner shoulder (see annotated fig. 5, below).
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Claim(s) 4-5 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eller and Howard as applied to claims 1 and 10 above, and further in view of Ethridge (US 2022/0125608 A1).
Regarding claims 4 and 11, Eller further teaches the middle region comprises: a first portion (see annotated fig. 1, below) and a second portion (see annotated fig. 1, below).
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Eller and Howard fail to teach a circumferential ridge. However, Ethridge teaches a stent a includes a first circumferential ridge disposed between the first portion and the second portion (964, flange, fig. 9). 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 middle region of Eller and Howard to include a first circumferential ridge disposed between the first portion and the second portion as taught by Ethridge in order to provide enhanced resistance to stent migration (¶ [0058], Ethridge).
Regarding claim 5 and 12, Eller and Howard fail to teach the diameter of the first circumferential ridge is larger than a diameter of the first portion of the middle region. However, Ethridge further teaches the diameter of the first circumferential ridge is larger than a diameter of the first portion of the middle region (fig. 9). 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 middle region of Eller and Howard to include the diameter of the first circumferential ridge is larger than a diameter of the first portion of the middle region as taught by Ethridge in order to provide enhanced resistance to stent migration (¶ [0058], Ethridge).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eller in view of Ethridge.
Regarding claim 16, Eller teaches a transluminal stent (100, fig. 1, abstract), comprising
a hollow body (101, fig. 1) comprising:
an interior space (102);
an exterior contour (103, fig. 1);
a first flared end (120, fig. 1), a second flared end (130, fig. 1), and a middle region that extends between the first flared end and the second flared end (110, fig. 1).
Eller fails to teach a concave, curvilinear shaped first portion, a concave, curvilinear shaped first portion and a first circumferential ridge. However, Ethridge teaches wherein the middle region comprises: a concave, curvilinear shaped first portion (see annotated fig. 9, below); a concave, curvilinear shaped second portion (see annotated fig. 9, below); and a first circumferential ridge disposed between the first portion and the second portion (964, fig. 9). 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 middle region of Eller to include a first portion, a second portion and a first circumferential ridge disposed between the first portion and the second portion as taught by Ethridge in order to provide enhanced resistance to stent migration (¶ [0058], Ethridge).
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Regarding claim 17, Eller further teaches wherein the first flared end comprises: a first crest extending from the second portion (124, fig. 5); a first opening (128, fig. 5); and a first outer taper extending between the first crest and the first opening (126, fig. 5).
Regarding claim 18, Eller further teaches wherein the first flared end further comprises a first inner shoulder extending between the first portion and the first crest (122, fig. 5).
Regarding claim 19, Eller fails to teach a diameter of the first circumferential ridge is larger than a diameter of the first portion. However, Ethridge further teaches a diameter of the first circumferential ridge is larger than a diameter of the first portion (fig. 9). 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 middle region of Eller to include a diameter of the first circumferential ridge is larger than a diameter of the first portion as taught by Ethridge in order to provide enhanced resistance to stent migration (¶ [0058], Ethridge).
Regarding claim 20, Eller fails to teach a diameter of the first circumferential ridge is larger than a diameter of the first portion. However, Ethridge further teaches a diameter of the second portion is larger than a diameter of the first portion but smaller than a diameter of the first circumferential ridge (fig. 9). 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 middle region of Eller to include a diameter of the first circumferential ridge is larger than a diameter of the first portion as taught by Ethridge in order to provide enhanced resistance to stent migration (¶ [0058], Ethridge).
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
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