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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/16/2026 has been entered.
Response to Amendment
The amendment filed 03/16/2026 has been entered. Claims 1-5, 7-19 and 21-22 remain pending. Claims 6 and 20 have been cancelled. Claim 23 has been added.
Response to Arguments
Applicant’s arguments with respect to claims 1, 10, and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 8, 12, and 14 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.
Regarding Claims 8, 12, and 14, the limitation “lower” is unclear as the claim does not set forth a direction/orientation of the device to compare the limitation of “lower”. Further clarification is required.
Claim Rejections - 35 USC § 102
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 1-5, 7-19, and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20140277363 A1 (hereafter --Armstrong--).
Regarding Claim 1, Armstrong discloses a delivery system comprising: an endoprosthesis (104) having a first end and a second end (see annotated first and second end in Figure 2 below), the endoprosthesis configured to transition from a compact, delivery configuration (see paragraph [0051]) to an enlarged, deployed configuration (see paragraph [0094], [0063], and [0060]);
a delivery catheter including a body portion and a tip portion (see annotated tip and body portions Figure 2), the endoprosthesis being received on the body portion of the delivery catheter in the compact delivery configuration (see paragraph [0082]), the tip portion including a lip configured to define a pocket that releasably receives the first end of the endoprosthesis in the compact, delivery configuration (see annotated lip including the flexible elements 110a-110h in Figure 2, see paragraph [0052] denoting that flexible elements can extend over a distal edge (first end) of endoprosthesis 104, the pocket being the area in which one of the flexible elements holds and overlaps with the endoprosthesis);
and a constraint (106) releasably maintaining the endoprosthesis in the compact, delivery configuration (see paragraph [0050] and [0051]) the constraint having a first end and a second end (see annotated first and second ends in Figure 2 below), the constraint extending over at least a portion of the endoprosthesis and the lip of the tip portion (see paragraph [0051 denoting that the constraint can be compressed against the ends of the endoprosthesis, and see also paragraph [0052] denoting that the portion of the lip portion that is the flexible elements can extend over, or overlap or overlay, a distal edge of the endoprosthesis, thereby the constraint is capable of extending over a portion of the lip portion, as the lip portion flexible elements can be overlapped or extended over the first end of the endoprosthesis, see also paragraph [0060] denoting that covering 106 can cover flexible element 110 (1802 in this embodiment)).
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Regarding Claim 2, Armstrong discloses the delivery system of claim 1, wherein the constraint (106) includes a tubular, knitted sleeve (see annotated constraint in Figure 2 below, see also paragraph [0051]).
Regarding Claim 3, Armstrong discloses the delivery system of claim 1, wherein the constraint is configured to unravel and deconstruct to release the endoprosthesis (see paragraph [0063]).
Regarding Claim 4, Armstrong discloses the delivery system of claim 1, wherein the lip of the tip portion is interposed between the first end of the endoprosthesis and the constraint (see paragraph [0051 denoting that the constraint can be compressed against the ends of the endoprosthesis, and see also paragraph [0052] denoting that the portion of the lip portion that is the flexible elements can extend over, or overlap or overlay, a distal edge of the endoprosthesis, thereby the constraint is capable of extending over a portion of the lip portion, as the lip portion flexible elements can be overlapped or extended over the first end of the endoprosthesis, see also paragraph [0060] denoting that covering 106 can cover flexible element 110 (1802 in this embodiment)).
Regarding Claim 5, Armstrong discloses the delivery system of claim 1, wherein the endoprosthesis includes a support portion (202a-202e) of one or more rows defined by a stent element defining an undulating pattern (see annotated rows in Figure 2 below), and further wherein the first end of the endoprosthesis releasably received in the pocket includes at least one of the one or more rows defined by the stent element (see paragraphs [0052] and [0053] denoting the flexible portions of the lip portion can overlap with apices 202 of the stent).
Regarding Claim 7, Armstrong discloses the delivery system of claim 1, wherein the lip of the tip portion is elastically deformable (see paragraphs [0052] and [0053] denoting that portions 110a-110h are flexible).
Regarding Claim 8, Armstrong discloses the delivery system of claim 1, wherein the lip of the tip portion is configured to transition to from a first configuration to a second configuration following release of the endoprosthesis from the pocket defined by the lip (see paragraph [0063]), the second configuration of the lip having a lower profile than the first configuration of the lip (the “lower profile” meaning that the flexible elements are more towards the distal or “lower” end, the flexible elements being capable of being in differing configurations as they are flexible able to bend as described in paragraph [0062])). Since the claim does not define “lower,” the limitation is being given its broadest reasonable interpretation to encompass a distal direction. Under an alternate interpretation, the material of a portion of the lip 402 is compressible and the stent embeds into the material 402 (see Figure 4, see also paragraph [0055]), the material 402 being a part of the lip of the delivery device, thereby compressing the lip into a “lower”/”smaller” radial profile that is a “second configuration”. The “first configuration” is the material at rest, without the stent embedded into it.
Regarding Claim 9, Armstrong discloses the delivery system of claim 1, wherein the tip portion includes a serrated portion configured to mechanically engage the first end of the constraint (the filaments 110 form a serrated structure (going up and down) with the underlying surface of the tip, see filaments 110 in Figure 2 above).
Regarding Claim 10, Armstrong discloses a delivery catheter comprising: a body portion configured to receive a self-expanding endoprosthesis (104) in a compact, delivery configuration (see paragraph [0051]); and a tip portion including a lip configured to releasably receive a first end of the self- expanding endoprosthesis in a compact, delivery configuration (see annotated lip including the flexible elements 110a-110h in Figure 2 above, see paragraph [0052] denoting that flexible elements can extend over a distal edge (first end) of endoprosthesis 104, the pocket being the area in which one of the flexible elements holds and overlaps with the endoprosthesis), wherein the first end of the self-expanding endoprosthesis overcomes a frictional force between the lip and the first end to release from a pocket defined by the lip as the self-expanding endoprosthesis transitions from the compact, delivery configuration to an enlarged, deployed configuration (see paragraph [0063]).
Regarding Claim 11, Armstrong discloses the delivery catheter of claim 10, wherein the lip of the tip portion is elastically deformable (see paragraphs [0052] and [0053] denoting that portions 110a-110h are flexible).
Regarding Claim 12, Armstrong discloses the delivery system of claim 1, wherein the lip of the tip portion is configured to transition to from a first configuration to a second configuration following release of the endoprosthesis from the pocket defined by the lip (see paragraph [0063]), the second configuration of the lip having a lower profile than the first configuration of the lip (the “lower profile” meaning that the flexible elements are more towards the distal or “lower” end, the flexible elements being capable of being in differing configurations as they are flexible able to bend as described in paragraph [0062]). Since the claim does not define “lower,” the limitation is being given it’s broadest reasonable interpretation to encompass a distal direction. Under an alternate interpretation, the material of a portion of the lip 402 is compressible and the stent embeds into the material 402 (see Figure 4, see also paragraph [0055]), the material 402 being a part of the lip of the delivery device, thereby compressing the lip into a “lower”/”smaller” radial profile that is a “second configuration”. The “first configuration” is the material at rest, without the stent embedded into it.
Regarding Claim 13, Armstrong discloses the delivery system of claim 1, wherein the tip portion includes a serrated portion configured to mechanically engage a constraint for an endoprosthesis (the filaments 110 form a serrated structure (going up and down) with the underlying surface of the tip, see filaments 110 in Figure 2 above).
Regarding Claim 14, Armstrong discloses a delivery system comprising: an endoprosthesis having a first end and a second end, the endoprosthesis configured to transition from a compact, (see paragraph [0051]) delivery configuration to an enlarged, deployed configuration (see paragraph [0094], [0063], and [0060]); a constraint (106) releasably maintaining the self-expanding endoprosthesis in the compact, delivery configuration (see paragraph [0051 denoting that the constraint can be compressed against the ends of the endoprosthesis); the endoprosthesis being received on the body portion of the delivery catheter in the compact delivery configuration (see paragraph [0082]), the tip portion including a lip configured to define a pocket that releasably receives the first end of the self-expanding (see paragraph [0094]) endoprosthesis in the compact, delivery configuration (see annotated lip including the flexible elements 110a-110h in Figure 2, see paragraph [0052] denoting that flexible elements can extend over a distal edge (first end) of endoprosthesis 104, the pocket being the area in which one of the flexible elements holds and overlaps with the endoprosthesis), the lip being configured to elastically transition from a first configuration to a second configuration upon the first end of the self-expanding endoprosthesis being released from the constraint (see paragraph [0063]), the second configuration having a lower profile than the first configuration (the “lower profile” meaning that the flexible elements are more towards the distal or “lower” end, the flexible elements being capable of being in differing configurations as they are flexible able to bend as described in paragraph [0062]). Since the claim does not define “lower,” the limitation is being given its broadest reasonable interpretation to encompass a distal direction. Under an alternate interpretation, the material of a portion of the lip 402 is compressible and the stent embeds into the material 402 (see Figure 4, see also paragraph [0055]), the material 402 being a part of the lip of the delivery device, thereby compressing the lip into a “lower”/”smaller” radial profile that is a “second configuration”. The “first configuration” is the material at rest, without the stent embedded into it.
Regarding Claim 15, Armstrong discloses the delivery system of claim 14, wherein the constraint extends over a portion of the lip of the tip portion (see paragraph [0051 denoting that the constraint can be compressed against the ends of the endoprosthesis, and see also paragraph [0052] denoting that the portion of the lip portion that is the flexible elements can extend over, or overlap or overlay, a distal edge of the endoprosthesis, thereby the constraint is capable of extending over a portion of the lip portion, as the lip portion flexible elements can be overlapped or extended over the first end of the endoprosthesis, see also paragraph [0060] denoting that covering 106 can cover flexible element 110 (1802 in this embodiment)).
Regarding Claim 16, Armstrong discloses the delivery system of claim 14, wherein the constraint is configured to unravel and deconstruct to release the endoprosthesis (see paragraph [0063]).
Regarding Claim 17, Armstrong discloses the delivery system of claim 14, wherein the lip of the tip portion is interposed between the first end of the endoprosthesis and the constraint (see paragraph [0051 denoting that the constraint can be compressed against the ends of the endoprosthesis, and see also paragraph [0052] denoting that the portion of the lip portion that is the flexible elements can extend over, or overlap or overlay, a distal edge of the endoprosthesis, thereby the constraint is capable of extending over a portion of the lip portion, as the lip portion flexible elements can be overlapped or extended over the first end of the endoprosthesis, see also paragraph [0060] denoting that covering 106 can cover flexible element 110 (1802 in this embodiment)).
Regarding Claim 18, Armstrong discloses the delivery system of claim 1, wherein the endoprosthesis includes a support portion (202a-202e) formed of one or more rows defined by a stent element defining an undulating pattern (see annotated rows in Figure 2 above), and further wherein the first end of the endoprosthesis releasably received in the pocket includes at least one of the one or more rows defined by the stent element (see paragraphs [0052] and [0053] denoting the flexible portions of the lip portion can overlap with apices 202 of the stent).
Regarding Claim 19, Armstrong discloses the delivery system of claim 1, wherein the first end of the endoprosthesis is configured to release from the pocket as the endoprosthesis transitions from the compact, delivery configuration to the enlarged, deployed configuration (see paragraph [0063]).
Regarding Claim 21, Armstrong discloses the delivery system of claim 1, wherein the first end of the self-expanding endoprosthesis is configured to expand upon removal of at least a portion of the constraint with an outward expansion force that overcomes engagement of the self-expanding endoprosthesis with the lip such that the first end of the self-expanding endoprosthesis releases from the pocket (see paragraph [0063]).
Regarding Claim 22, Armstrong discloses the delivery system of claim 1, wherein the lip includes a first member and a second member opposing the first member, the first and second members defining a lumen therebetween, wherein the first end of the self-expanding endoprosthesis is receivable within the lumen in the compact, delivery configuration (see annotated first and second members in Figure 2 below, the lumen being the circular space in between all of the flexible members that receive in the apices of the stent, see also paragraphs [0051] and [0052]).
Regarding Claim 23, Armstrong discloses the delivery system of claim 10, further including a constraint (106) maintaining the self-expanding endoprosthesis in the compact, delivery configuration and the constraint extending over a portion of the lip of the tip portion (see paragraph [0051 denoting that the constraint can be compressed against the ends of the endoprosthesis, and see also paragraph [0052] denoting that the portion of the lip portion that is the flexible elements can extend over, or overlap or overlay, a distal edge of the endoprosthesis, thereby the constraint is capable of extending over a portion of the lip portion, as the lip portion flexible elements can be overlapped or extended over the first end of the endoprosthesis, see also paragraph [0060] denoting that covering 106 can cover flexible element 110 (1802 in this embodiment)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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