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 .
Election/Restrictions
Claim(s) 6-8, 11, 13-14, 20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/24/2026. (PLEASE NOTE: Applicant withdrew claims 11, 13, and 20 as being drawn to nonelected species; Examiner is further withdrawing: claim(s) 6-7 as being drawn to nonelected species A8 (for the nested in an angular manner from claim 6); claim(s) 8 and 14 as being drawn to non-elected species D1 (for the wall construction enabling a stiff configuration and a flexible configuration (from claim(s) 8 and 14).)
Applicant's election with traverse of Species A7, B1, C1, D2 in the reply filed on 6/24/2026 is acknowledged. The traversal is on the ground(s) that a claim is generic; specifically, claim 10 is generic to at least species A2, A3, A4 A7 and A8. This is not found persuasive because although applicant is correct that claim 10 is generic to some of the species this does not address the additional search burden created by the distinct/ different patently species as listed by applicant’s originally filed disclosure. If Applicant believes that these are in fact similar and should not be considered mutually exclusive species, the applicant is required to state that these embodiments do not have mutually exclusive characteristics and a single prior art disclosing one species would disclose the other since they are obvious variants of each other.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/275868, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 63/275868 fails to provide adequate support or enablement for the nose cone being of a series of nested layers/ layers (as required by independent claim(s) 1 and 21). As such, claim(s) 1-5, 9, 17-19, 21 are awarded a priority date of November 2 2022; claim(s) 10, 12, 15 are awarded a priority date of November 4, 2021.
Claim Objections
Claim(s) 21 is/are objected to because of the following informalities:
Within claim 21, line 7: “nosecone” should be split into two words.
Appropriate correction is required.
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(s) 1-5, 9-10, 12, 15, 19 is/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 1 recites the limitation "the patient’s vasculature" in line 11. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 2-5, 9, which depend from claim 1, inherit all the problems associated with claim 1.
Claim 1 recites the limitation "the heart" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Within claim 2, lines 2-3: Applicant claims, “wherein the nose cone transitions to the collapsed state when the inner catheter is pulled”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the scope of the claim is determined by the preamble, which is the system alone; however, the aforementioned claim requirement is directed to the method as applicant is claiming the transitioning. For the purposes of examination, Examiner is assuming the aforementioned claim requirement should instead be rewritten as --wherein the nose cone is configured to transition to the collapsed state when the inner catheter is pulled--.
Within claim 5, lines 1-2: Applicant claims, “a distal end of the delivery catheter”; it is unclear, and therefore indefinite, if this is the same as OR in addition to the “distal end of the delivery catheter” within claim 1, lines 9-10.
Claim 10 recites the limitation "the patient’s vasculature" in line 11. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 12, 15, which depend from claim 10, inherit all the problems associated with claim 10.
Claim 10 recites the limitation "the heart" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the inner catheter" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Within claim 19, line 2: Applicant claims, “a tapered elongate shape”; it is unclear, and therefore indefinite, if this is the same as OR in addition the “tapered elongate shape” within claim 21, line 5.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 17, 21 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Bowe (US 2012/0277845 A1).
With respect to claim 21:
Bowe discloses a prosthetic heart valve delivery system (medical device delivery system 40), as can be seen in figs. 1-3 or 20-22 (paragraph [0045, 0108]), comprising:
a proximal handle (elongate handle 43), as can be seen in fig. 25 (paragraph [0120]);
an elongate delivery catheter (sheath 80) extending distally from the proximal handle (elongate handle 43) (paragraph [0047]); and
a nose cone (proximal tip portion 50) positioned at a distal end (proximal end 81) of the elongate delivery catheter (sheath 80) including a series of layers (telescoping members 10, 12, 14, 16), as can be seen in figs. 20-22, that forms a tapered elongated shape, the nose cone (proximal tip portion 50) operatively coupled to the proximal handle (elongate handle 43) such that at least some of the layers (telescoping members 10, 12, 14, 16) may be repositioned (longitudinally retractable) by manipulation of the proximal handle (elongate handle 43) to reduce a length of the nosecone (paragraphs [0046, 0050-005, 0108]).
With respect to claim 17:
Wherein the further comprising an inner catheter (mechanical actuator 140) attached to a distal end portion (fourth telescoping member 16) of the nose cone (proximal tip portion 50) and wherein the nose cone (proximal tip portion 50) transitions to a collapsed state (as seen in fig. 22) when the inner catheter (mechanical actuator 140) is pulled (paragraphs [0051, 0093, 0108]).
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.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowe (US 2012/0277845 A1) in view of Gautam et al. (US 2012/0158128 A1).
With respect to claim 18:
Bowe disclose the invention substantially as claimed, as discussed above. However, Bowe does not disclose the nose cone (proximal tip portion 50) to be surrounded by a flexible cover (as required by claim 18).
Gautum et al. teaches a system for packaging a sterilized a prosthetic heart valve and the delivery system thereof in a two layer system comprising a flexible cover (flexible pouch) (paragraph [0011]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the two layer sterile packaging system, as taught by Gautum et al., for the prosthetic heart valve delivery system (medical device delivery system 40), as disclosed by Bowe, as the prosthetic heart valve delivery system (medical device delivery system 40), as disclosed by Bowe, will need to be assembled and sterilized prior to shipping and implantation (to ensure a sterile procedure is completed). (Please note: in making the aforementioned combination as least during storage/ prior to surgery the nose cone (proximal tip portion 50), as disclosed by Bowe, will be surrounded by the flexible cover (flexible pouch), as taught by Gautum et al..)
With respect to claim 19:
Wherein the nose cone (proximal tip portion 50), as disclosed by Bowe, is formed of a series of stacked nested layers (telescoping members 10, 12, 14, 16), as can be seen in figs. 20-22, which form a tapered elongated shape in an extended state (as can be seen in fig. 1 and 20), and which may be collapsed longitudinally (longitudinally retractable) to the collapsed state (as seen in fig. 22) for reducing contact (capable of reducing contact) with a wall of a heart (Bowe paragraph [0110]).
Claim(s) 1-2, 5, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowe (US 2012/0277845 A1) in view of Tran et al. (US 2011/0251680 A1).
With respect to claim 1:
Bowe discloses the invention substantially as claimed. Specifically, Bowe discloses a prosthetic heart valve delivery system (medical device delivery system 40), as can be seen in figs. 1-3 and 20-22 (paragraph [0045]), comprising:
a flexible access sheath (pusher 44) having a lumen (paragraph [0120]);
a proximal handle (elongate handle 43), as can be seen in fig. 25 (paragraph [0120]);
a delivery catheter (sheath 80) extending distally from the proximal handle (elongate handle 43) (paragraph [0047]), the delivery catheter (sheath 80) having an outer diameter sized to fit through the lumen of the access sheath (pusher 44 ends before the implant, therefore the sheath 80 must extend therethrough) (paragraph [0120]), the delivery catheter (sheath 80) also formed with a lumen (lumen 83) extending therethrough (paragraph [0055]);
an expandable implant (medical device 104) adapted to be crimped and positioned within the lumen of the delivery catheter (sheath 80) along a distal end portion of the delivery catheter (sheath 80) (paragraphs [0045-0047]);
a tapered nose cone (proximal tip portion 50) coupled to and projecting distally from a distal end (proximal end 81) of the delivery catheter (sheath 80) in an extended state (as can be seen in figs. 1-2), the nose cone (proximal tip portion 50) adapted to facilitate passage of the delivery catheter (sheath 80) through the patient's vasculature, wherein the nose cone (proximal tip portion 50) is formed of a series of nested layers (telescoping members 10, 12, 14, 16), as can be seen in figs. 20-22, which form a tapered elongated shape in the extended state (as can be seen in fig. 20) and which may be collapsed longitudinally (longitudinally retractable) to a collapsed state (as can be seen in fig. 22) for reducing contact with a wall of the heart (paragraphs [0046, 0050-0051, 0108, 0110]); and
an inner catheter (mechanical actuator 140) extending from the proximal handle (elongate handle 43) through the lumen (lumen 83) of the delivery catheter (sheath 80), through the implant, and attached to the nose cone (proximal tip portion 50) (paragraphs [0051, 0093, 0108]).
However, Bowe does not disclose the expandable implant to be a prosthetic heart valve.
Tran et al. discloses a self-expanding prosthetic heart valve configured to be delivered percutaneously just past the aortic arch in the aortic valve (paragraph [abstract]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the prosthetic heart valve delivery system (medical device delivery system 40), as disclosed by Bowe, to deliver the self-expanding prosthetic heart valve, as taught by Tran et al., as the two implants are expandable by the same method (both are self-expanding) and track to locations adjacent to each other (the aortic valve vs the aortic arch) as such the tools used therefore would be obvious substitutes for each other.
With respect to claim 2:
Wherein the inner catheter (mechanical actuator 140) is attached to a distal end portion (fourth telescoping member 16 of proximal end 51) of the nose cone (proximal tip portion 50) and wherein the nose cone (proximal tip portion 50) transitions to the collapsed state (as seen in fig. 22) when the inner catheter (mechanical actuator 140) is pulled (paragraphs [0051, 0093, 0110]).
With respect to claim 5:
Wherein the nose cone (proximal tip portion 50) may be advanced beyond a distal end (proximal end 81) of the delivery catheter (sheath 80) (independently movable) (paragraph [0054]).
With respect to claim 10:
Bowe discloses the invention substantially as claimed. Specifically, Bowe discloses a prosthetic heart valve delivery system (medical device delivery system 40), as can be seen in figs. 1-3 and 20-22 (paragraph [0045]), comprising:
a flexible access sheath (pusher 44) having a lumen (paragraph [0120]);
a proximal handle (elongate handle 43), as can be seen in fig. 25 (paragraph [0120]);
a delivery catheter (sheath 80) extending distally from the proximal handle (elongate handle 43) (paragraph [0047]), the delivery catheter (sheath 80) having an outer diameter sized to fit through the lumen of the access sheath (pusher 44 ends before the implant, therefore the sheath 80 must extend therethrough) (paragraph [0120]), the delivery catheter (sheath 80) also formed with a lumen (lumen 83) extending therethrough (paragraph [0055]);
an expandable implant (medical device 104) adapted to be crimped and positioned within the lumen of the delivery catheter (sheath 80) along a distal end portion of the delivery catheter (sheath 80) (paragraphs [0045-0047]);
a tapered nose cone (proximal tip portion 50) coupled to and projecting distally from a distal end (proximal end 81) of the delivery catheter (sheath 80) in an extended state (as can be seen in figs. 1-2), the nose cone (proximal tip portion 50) adapted to facilitate passage of the delivery catheter (sheath 80) through the patient's vasculature, the nose cone (proximal tip portion 50) being collapsible to a collapsed state for reducing contact with a wall of the heart, and wherein the inner catheter (mechanical actuator 140) extends through the nose cone (proximal tip portion 50) to a distal end thereof, and the nose cone (proximal tip portion 50) is configured to invert upon itself (fold into itself) when the inner catheter (mechanical actuator 140) is pulled (paragraphs [0108, 0110]); and
an inner catheter (mechanical actuator 140) extending from the proximal handle (elongate handle 43) through the lumen (lumen 83) of the delivery catheter (sheath 80), through the implant, and attached to the nose cone (proximal tip portion 50) (paragraphs [0051, 0093, 0108]).
However, Bowe does not disclose the expandable implant to be a prosthetic heart valve.
Tran et al. discloses a self-expanding prosthetic heart valve configured to be delivered percutaneously just past the aortic arch in the aortic valve (paragraph [abstract]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the prosthetic heart valve delivery system (medical device delivery system 40), as disclosed by Bowe, to deliver the self-expanding prosthetic heart valve, as taught by Tran et al., as the two implants are expandable by the same method (both are self-expanding) and track to locations adjacent to each other (the aortic valve vs the aortic arch) as such the tools used therefore would be obvious substitutes for each other.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowe (US 2012/0277845 A1) as modified by Tran et al. (US 2011/0251680 A1) as applied to claim(s) 1-2, 5, 10 above, and further in view of Gautam et al. (US 2012/0158128 A1).
Bowe as modified by Tran et al. disclose the invention substantially as claimed, as discussed above. However, Bowe as modified by Tran et al. does not disclose the nose cone (proximal tip portion 50) to be surrounded by a flexible cover.
Gautum et al. teaches a system for packaging a sterilized a prosthetic heart valve and the delivery system thereof in a two layer system comprising a flexible cover (flexible pouch) (paragraph [0011]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the two layer sterile packaging system, as taught by Gautum et al., for the prosthetic heart valve and prosthetic heart valve delivery system (medical device delivery system 40), as disclosed by Bowe as modified by Tran et al., as the prosthetic heart valve and prosthetic heart valve delivery system (medical device delivery system 40), as disclosed by Bowe as modified by Tran et al., will need to be assembled and sterilized prior to shipping and implantation (to ensure a sterile procedure is completed). (Please note: in making the aforementioned combination as least during storage/ prior to surgery the nose cone (proximal tip portion 50), as disclosed by Bowe as modified by Tran et al., will be surrounded by the flexible cover (flexible pouch), as taught by Gautum et al..
Claim(s) 9, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowe (US 2012/0277845 A1) as modified by Tran et al. (US 2011/0251680 A1) as applied to claim(s) 1-2, 5, 10 above, and further in view of Adamson (US 2013/0110085 A1).
With respect to claim 9, 15:
Bowe as modified by Tran et al. disclose the invention substantially as claimed, as discussed above. However, Bowe as modified by Tran et al. does not disclose the flexible access sheath (pusher 44), as disclosed by Bowe, to have a wall construction that enables conversion between an extended configuration to an axially collapsed configuration (as required by claim(s) 9, 15).
Adamson teaches a catheter comprising a wall construction (adjustable region) that enables conversion between an extended configuration to an axially collapsed configuration (allowing proximal length adjustment), thereby allowing more flexibility when selecting catheters (such that different length catheters don’t need to be replaced in cases where the surgeon misjudged the catheter length needed for the procedure) (paragraph [abstract, 0004-0005]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to add the adjustable regions, as taught by Adamson, to the flexible access sheath (pusher 44), as disclosed by Bowe, in order to allow implantation at locations a variety of distances form the vascular access site without requiring the switching of the delivery catheter systems.
Allowable Subject Matter
Claim(s) 4, 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious:
With respect to claim 4:
The delivery system (as required by claim 1) wherein the nested layers are biased into the tapered elongated shape (this is in direct conflict with the tapered nose cone (proximal tip portion 50), as disclosed by Bowe, which has no biased/ memorized shape and instead is controlled by the mechanical actuator 140).
With respect to claim 12:
The delivery system (as required by claim 10) wherein the nose cone is flat in the collapsed state (this is in direct conflict with the tapered nose cone (proximal tip portion 50), as disclosed by Bowe, which will have a non-flat shape created by the nesting of the telescoping components, as seen in fig. 22).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774
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