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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 04/06/2026 has been entered.
Claims 151 and 159 have been amended and claims 162-164 have been newly added.
Response to Arguments
Applicant's arguments, see pg. 5-7, filed 04/06/2026, with respect to the rejects of the claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that Pellegrini fails to teach “a stent device with three rings, where the first ring, the second ring, and the third ring are arranged in series along the longitudinal axis of the stent device, and each of the three rings have multiple flarable crowns which automatically flare radially outwardly relative to other portions of the respective one of the first, second and third rings upon radial expansion of the body portion so as to form multiple flared crowns (a plurality of crowns for each ring), wherein all of the crowns for the first and third rings flare outwardly in a first direction while all of the crowns of the second ring flare outwardly in a second direction” as required by amended claim 151.
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The Examiner disagrees. As shown in annotated Fig. 13 above, Pellegrini teach a stent device with first, second and third rings arranged in series along the longitudinal axis of the device. Each ring includes a plurality of flared crowns. Fig. 13 shows the third ring having at least 4 flared crowns as indicated by the crowns with flaring connectors 120 and the crowns shown projecting away from the surface of the balloon 1307. The first and second rings are shown having at least two flared crowns as indicated by the crowns shown projecting away from the surface of the balloon. Each of these flared portions are understood to include a y-shaped flaring connector 120 even though not all are labeled or drawn in Fig. 13 since Pellegrini discloses that y-shaped connectors 120 cause the crowns to flare and are attached to any crown that is intended to flared upon expansion (see [0029] and [0034]).
The crowns of the third ring are understood to be oriented towards the first end shown in annotated Fig. 13 based on the orientation of the flaring connectors 120 and the Pellegrini’s disclosure that the non-flared ends of the stent attach to the body of the stent by longitudinal struts 118. By the same logic, the crowns of the second ring are understood to flare towards the second end and the crowns of the first ring are understood to flare towards the first end.
Claim Objections
Claim 151 objected to because of the following informalities:
Claim 151 lines 4-6 should read “…a first flaring connector configured to flare a portion of the first ring, a second ring, a second flaring connector configured to flare a portion of the second ring, a third ring, and a third flaring connector…”
Appropriate correction is required.
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.
Claim 151 is 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 151 recites “each of the first flaring connector, the second flaring connector, and the third flaring connector is configured to cause each crown of a respective one of the first ring, the second ring, and the third ring to automatically flare radially outwardly.” In other words, claim 151 claims a singular flaring connector is configured to cause more than one crown of a respective ring to flare which is not disclosed in the application as originally filed.
It is disclosed multiple times throughout the specification and figures that each flarable crown has its own flaring connector configured to cause the crown to flare. For example, see Fig. 33-34 where each flarable crown has its own y-shaped flaring connector. See also for example [0010] of the Specification which states describes “…[the] at least one flaring connector connected to the at least one ring configured to cause a crown of the at least one ring to automatically flare radially outwardly…” Based on the specification and figures, it is understood that when there are a plurality of flarable crowns, there are a plurality of flaring connectors, each configured to cause a singular crown of a respective ring to flare. Therefore, “each of the first flaring connector, the second flaring connector, and the third flaring connector is configured to cause each crown of a respective one of the first ring, the second ring, and the third ring to automatically flare radially outwardly” in claim 151 is considered new matter.
Appropriate action is required.
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 151-164 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 151 recites “each of the first flaring connector, the second flaring connector, and the third flaring connector is configured to cause each crown of a respective one of the first ring, the second ring, and the third ring to automatically flare radially outwardly” which renders the scope of the claim indefinite since it is unclear how a singular flaring connector can cause multiple crowns of a respective ring to flare. For examination purposes, this limitation has been interpreted “each of the first flaring connector, the second flaring connector, and the third flaring connector is configured to cause a crown of a respective one of the first ring, the second ring, and the third ring to automatically flare radially outwardly.”
If Applicant wishes to make clear the relationship between the flaring connectors and the flarable crowns, it is recommended that claim 151 is amended to recite a plurality of first flaring connectors, a plurality of second flaring connectors and a plurality of third flaring connectors each configured to cause a respective crown of a respective one of the first ring, the second ring, and the third ring to automatically flare radially outwardly.
It is noted, that if Applicant amends claim 151 as suggested, all claims that make reference to the flaring connectors (claims 152, 153, 155 and 156) would also have to be amended to avoid further clarity issues.
Claims 152-164 are similarly rejected by virtue of their dependency from claim 151.
Claim 155 recites the limitation “the crown of the first ring” in lines 2 and 4 which renders the scope of the claim indefinite since there are a plurality of crowns of the first ring and it is unclear which crown of the plurality of crowns “the crown” refers to. For examination purposes, “the crown of the first ring” has been interpreted as “the crowns of the first ring.”
Claim 160 similar recites “the crown of the first ring” and “the crown of the second ring” which renders the scope of the claim indefinite since there are a plurality of crowns of the first and second rings. For examination purposes, “the crown of the first ring” and “the crown of the second ring” have been interpreted as “the crowns of the first ring” and “the crowns of the second ring,” respectively.
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.
Claims 151-164 are rejected under 35 U.S.C 102(a)(1) as being anticipated by Pellegrini (US 2009/0248139).
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Regarding claim 151, Pellegrini discloses a stent device (100, see Fig. 1 and annotated Fig. 13 above), comprising: a body portion extending along a longitudinal axis of the stent device defining a lumen (the body of the stent is made of rings 108 and there can be any number of rings 108 depending upon the desired length of the stent, see [0025]), the body portion being radially expandable; and a first ring, a first flaring connector configured to flare a portion of the first ring, second ring, a second flaring connector configured to flare a portion of the second ring, a third ring, and third flaring connector configured to flare a portion of the third ring (see first, second and third rings in annotated Fig. 13 each including a plurality of flared crowns, and Pellegrini discloses flaring connector 120 cause the crowns of the rings to flare, see [0034]), and wherein the first ring, the second ring, and the third ring are arranged in series along the longitudinal axis of the stent device (see annotated Fig. 13), wherein the first ring includes a first plurality of flarable crowns, each of the first plurality of crowns oriented in a first direction, wherein the second ring includes a second plurality of flarable crowns, each of the second plurality of crowns oriented in a second direction opposite the first direction, wherein the third ring includes a third plurality of flarable crowns, each of the third plurality of crowns oriented in the first direction (the crowns of the third ring are understood to be oriented toward the first end based on the orientation of the y-shaped connectors in the figure, the crowns of the second ring are understood to be oriented toward the second end based on the spacing shown and Pellegrini’s disclosure that the non-flared ends of the stent rings attach to the body of the stent by connections 118, see Fig. 1, and the crowns of the first ring are understood to be oriented towards the first end because of the spacing shown) and wherein each of the first flaring connector, the second flaring connector, and the third flaring connector is configured to cause a crown of a respective one of the first ring, the second ring, and the third ring to automatically flare radially outwardly relative to other portions of the respective one of the first, second and third rings upon radial expansion of the body portion so as to form a first plurality of flared crowns, a second plurality of flared crowns, and a third plurality of flared crowns (flaring connectors 120 are configured to cause crowns 112 to automatically flare radially outwardly upon radial expansion of the body portion, see [0029]), wherein the first plurality of flared crowns and the third plurality of flared crowns flare outwardly toward a first end of the body portion while the second plurality of flared crowns flares outwardly toward a second end of the body portion (as described above, the crowns of the first and third rings are understood to flare towards the first end and the crowns of the second ring are understood to flare towards the second end, see annotated Fig. 13).
Regarding claim 152, Pellegrini discloses the stent device of claim 151, wherein the first flaring connector, the second flaring connector, and the third flaring connector are not biased toward a radially expanded position (flaring connectors 120 may not flare automatically, but may be expandable by radial force of a balloon, see [0043]).
Regarding claim 153, Pellegrini discloses the stent device of claim 151, wherein the first flaring connector, the second flaring connector, and the third flaring connector are biased toward a radially expanded position (flaring connectors 120 may be formed of a superelastic material and biased to take on the flared configuration when the stent device is unsheathed, see [0041]).
Regarding claim 154, Pellegrini discloses the stent device of claim 151, wherein each of the first ring, the second ring, and the third ring comprises a plurality of substantially repeating bent segments (each ring 108 comprises a plurality of bent segments, see Fig. 1) and a longitudinally extending strut that connects a first one of the bent segments to the body portion of the stent device (longitudinally extending struts 118 connect adjacent rings 108, see Fig. 1 and [0026]), and wherein each bent segment comprises a peak, a valley, and a transition region disposed between the peak and the valley (the bent segment comprises a peak, valley and transition region, see Fig. 1).
Regarding claim 155, Pellegrini discloses the stent device of claim 151, wherein, upon the radial expansion of the body portion, the first flaring connector is configured to transition from a retracted position, in which the crowns of the first ring are substantially longitudinally aligned with portions of the body portion of the stent device (when the stent is unexpanded, crowns 112 are parallel with the longitudinal axis La of the stent, see [0024] and Fig. 1), to an expanded position, in which the crowns of the first ring flare radially outwardly relative to other portions of the body portion of the stent device (upon expansion of the stent, crowns 112 having flaring connectors 120 are angled with respect to the body of the stent, see [0024]).
Regarding claim 156, Pellegrini discloses the stent device of claim 155, wherein, when the first flaring connector, the second flaring connector, and the third flaring connector are in the retracted position, the crowns of the first ring, the second ring, and the third ring are equidistant from the longitudinal axis with the other portions of the first ring, the second ring, and the third ring (in the unexpanded position, the crowns of the radially expandable rings having a flaring connector 120 are equidistant to the longitudinal axis compared with other portion of the ring, see Fig. 1), and wherein, when the first flaring connector, the second flaring connector, and the third flaring connector are in the expanded position, the crowns of the first ring, the second ring, and the third ring are located farther from the longitudinal axis than the other portions of the first ring, the second ring, and the third ring (in the expanded position, the crowns of the radially expandable rings having a flaring connector 120 are angled from the longitudinal axis, which would mean that the crowns are located father from the central longitudinal axis than the non-flaring portions of the ring, see [0024]).
Regarding claim 157, Pellegrini discloses the stent device of claim 151, wherein an end of the stent device forms an outwardly flarable portion (the rings at each end of the stent in Fig. 13 forms an outwardly flarable portion).
Regarding claim 158, Pellegrini discloses the stent device of claim 151, wherein the body portion comprises a first longitudinal section and a second longitudinal section, and an outwardly flarable portion disposed between the first longitudinal section and the second longitudinal section. For examination purposes, the outwardly flarable portion has been interpreted as being defined by the flared portions of the stent. Pellegrini teaches a stent with six rings with, each having outwardly flarable portions (see Fig. 13), each ring is connected to a subsequent ring by a longitudinally extending strut 118 (see [0026] and Fig. 1), therefore the rings with flarable portions in the middle of the device shown in Fig. 13 are disposed between a first longitudinal section and a second longitudinal section, each formed by longitudinally extending struts 118.
Regarding claim 160, Pellegrini discloses the stent device of claim 151, wherein the crowns of the first ring flare radially outwardly and away from the crowns of the second ring and the crowns of the second ring flare radially outward and away from the crowns of the first ring (the crowns of the first and second rings flare in opposite directions, see annotated Fig. 13 above).
Regarding claim 162, Pellegrini discloses the stent device of claim 151, further comprising an outwardly flarable portion configured to, in response to radial expansion of the body portion, move to a flared position, in which the outwardly flarable portion has a wider diameter and encloses a larger cross-sectional area than other portions of the stent device when the stent device is extended (each ring in Fig. 13 forms an outwardly flarable portion and these portions necessarily have a wider diameter and enclose a larger cross-sectional area than the non-flared portions of the stent).
Regarding claim 163, Pellegrini discloses the stent device of claim 151, further comprising a cover (there may be a graft material enclosing or lining the stent, see [0027]).
Regarding claim 164, Pellegrini discloses the stent device of claim 163, further comprising an outwardly flarable portion and wherein the first ring is configured to reduce a force applied on the second ring by the cover, allowing for a more uniform expansion of the outwardly flarable portion.
It is noted that the language “the first ring is configured to reduce a force applied on the second ring by the cover, allowing for a more uniform expansion of the outwardly flarable portion” constitutes functional language indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Pellegrini meets the structural limitations of the claim, and the first ring is capable of reducing a force applied on the second ring since the arrangement of the first and second ring of Pellegrini are exactly as disclosed by Applicant for reducing force on the second ring and allowing for more uniform expansion of the outwardly flarable portion.
Regarding claim 159, Pellegrini discloses the stent device of claim 163, wherein the third ring is configured to flare radially outwardly to lessen an amount the cover needs to stretch to accommodate the second ring that flares radially outwardly.
It is noted that the language “configured to flare radially outwardly to lessen an amount a cover provided on the stent device needs to stretch to accommodate the at least one second ring that flares radially outwardly” constitutes functional language indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Pellegrini meets the structural limitations of the claim, and the third ring is capable of reducing the amount a cover provided on the stent needs to stretch to accommodate the at least one second ring since it understood that the more flaring rings there are in the device, the more uniformly distributed the force applied on each ring by a cover and therefore the less the amount of stretch required by the cover to accommodate any particular ring.
This interpretation is consistent with Applicant’s disclosure that additional flaring rings in the device reduce force applied by a cover on any individual ring (see Specification [00264]).
Conclusion
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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