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.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-3, 15-20, and 32-33 in the reply filed on 01/26/2026 is acknowledged. Claims 4-14 and 21-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/26/2026.
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 1, 15-18, and 32-33 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 Claim 1, the limitation “upwards” is indefinite as it is unclear what “upwards” is relative to. For example, upwards could be differing directions dependent on if it is relative to the patient, the operator, or a part of the delivery device. Further clarification is required.
Regarding Claim 15, the limitation “upwards” is indefinite as it is unclear what “upwards” is relative to. For example, upwards could be differing directions dependent on if it is relative to the patient, the operator, or a part of the delivery device. Further clarification is required.
Regarding Claim 15, it is unclear whether or not Applicant prefers the claim be dependent on claim 1 or 2, as the claim mentions claim 2, a claim that it is not dependent on. For purposes of expedited prosecution, the Examiner is interpreting that the claim is dependent on claim 1, and the limitation “determined according to claim 2” be removed. Further clarification is required. Claims 16 and 17 are deemed indefinite due to their dependency on claim 15.
Regarding Claim 17, the limitation “upwards” is indefinite as it is unclear what “upwards” is relative to. For example, upwards could be differing directions dependent on if it is relative to the patient, the operator, or a part of the delivery device. Further clarification is required.
Regarding Claim 18, the limitation “upwards” is indefinite as it is unclear what “upwards” is relative to. For example, upwards could be differing directions dependent on if it is relative to the patient, the operator, or a part of the delivery device. Further clarification is required.
Regarding Claim 32, it is unclear whether or not Applicant prefers the claim be dependent on claim 1 or 2, as the claim mentions claim 2, a claim that it is not dependent on. For purposes of expedited prosecution, the Examiner is interpreting that the claim is dependent on claim 1, and the limitation “determined according to claim 2” be removed. Further clarification is required.
Regarding Claim 33, the limitation “upwards” is indefinite as it is unclear what “upwards” is relative to. For example, upwards could be differing directions dependent on if it is relative to the patient, the operator, or a part of the delivery device. 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 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20230190466 A1 (hereafter --Bialas--).
Regarding Claim 1, Bialas discloses a method for implanting a prosthetic valve in a patient's body with minimum misalignment of commissures of the prosthetic valve to the commissures of a native aortic valve, the method comprising: determining an Angle of Commissural Alignment (AoCA) of a native aortic valve of a patient to be treated (see paragraphs [0382], [0456], and [0469] denoting that the predetermined amount of offset can be determined based on a desired imaging view selected for viewing the delivery apparatus in a heart during an implantation procedure (e.g., based on a known location of the target commissure of the native valve within the selected imaging view)); crimping a prosthetic valve having three commissures on a delivery system having one or more aligners marked on its outer shaft (see annotated delivery system, outer shaft, and aligners in Figures 9-11 below, see also paragraph [0206]) wherein, the one or more aligners follow same axis (see annotated axis in Figures 9-11), the crimping of the prosthetic valve on the delivery system is done using at least one of a crimper or a confirmation gauge that includes one or more angle markings on at least one of its faces (see paragraphs [0383], [0384], and [0385], denoting that the valve can be crimped, describing a crimping device, see also paragraph [0395] denoting the alignment member can have other configurations, such as a recess or other alignment feature that is configured to mate with a corresponding mating interface of the crimping device), the crimping of the prosthetic valve on the delivery system is performed such that one of the commissures of the prosthetic valve is axially aligned with the AoCA identified on the angle markings on one of the crimper or the confirmation gauge and at the same time (see paragraph [0383] denoting a selected commissure of the prosthetic valve is circumferentially offset from the marker), the one or more aligners face upwards (see paragraph [0234] denoting the marker can be facing upwards); and implanting the crimped prosthetic valve by maintaining the one or more aligner/s pointing upward during the entire implantation procedure (see paragraphs [0234] and [0249] denoting the marker can be facing upwards, see also paragraphs [0465], [0469], [0471] denoting that the method includes rotating of the shaft so that the marker is centered along the guidewire and visible in the imaging, “up” meaning visible to the imaging).
Regarding Claim 33, Bialas discloses method of claim 1 wherein, the step of implanting the prosthetic valve being a self-expanding prosthetic valve, includes: inserting the distal end of the delivery system that has the prosthetic valve mounted on it in radially collapsed condition into the patient's vasculature through an introducer sheath (see paragraphs [0462] and [0003], see also paragraph [0171]) keeping the aligner/s provided on the outer shaft of the delivery catheter facing upward (see paragraphs [0234] and [0249] denoting the marker can be facing upwards, see also paragraphs [0465], [0469], [0471] denoting that the method includes rotating of the shaft so that the marker is centered along the guidewire and visible in the imaging, “up” meaning visible to the imaging), navigating the delivery system through patient's vasculature under fluoroscopic guidance till the prosthetic valve and the balloon have crossed the aortic annulus taking care that the aligner/s face upward during the entire implantation procedure (see paragraph [0169] denoting the implant can be implanted into the aortic annulus, see also paragraphs [0253], [0288], [0289] denoting that the implant is delivered through fluoroscopic guidance, see also paragraphs [0465], [0469], [0471] denoting that the method includes rotating of the shaft so that the marker is centered along the guidewire and visible in the imaging, “up” meaning visible to the imaging) parking the prosthetic valve at the target implantation location, and allowing the prosthetic valve to self-expand by withdrawing the outer shaft or the retaining sheath gradually in the proximal direction to uncover the crimped prosthetic valve (see paragraph [0171]) maintaining the upward orientation of the aligner/s (see paragraphs [0234] and [0249] denoting the marker can be facing upwards, see also paragraphs [0465], [0469], [0471] denoting that the method includes rotating of the shaft so that the marker is centered along the guidewire and visible in the imaging, “up” meaning visible to the imaging).
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20230190466 A1 (hereafter --Bialas--), in view of US 20070112422 A1 (hereafter –Dehdashtian--).
Regarding Claim 18, Bialas discloses the method of implanting the crimped prosthetic valve being a balloon expandable prosthetic valve, includes: inserting an introducer sheath in the vasculature of the patient, preferably into a femoral artery (see paragraphs [0462] and [0003]); inserting a distal end of the delivery system having the balloon with the prosthetic valve crimped on it into the introducer sheath (see paragraph [0171]) with the aligners on the outer shaft of the delivery catheter facing upwards (see paragraphs [0234] and [0249] denoting the marker can be facing upwards), maintaining upward orientation of the aligners while navigating the crimped prosthetic valve through the patient's vasculature to desired deployment site in the aortic annulus (see paragraphs [0465], [0469], [0471] denoting that the method includes rotating of the shaft so that the marker is centered along the guidewire and visible in the imaging, “up” meaning visible to the imaging, see also paragraph [0479] that different imaging views with respect to the marker can be used); deploying the prosthetic valve by inflating the balloon of the delivery system maintaining upward orientation of the aligners (see paragraph [0377]).
Bialas fails to disclose deflating the balloon of the delivery system after deploying the prosthetic valve; and withdrawing the delivery system shaft along with the balloon out from the patient's vasculature.
Dehdashtian discloses a method of delivering a prosthetic heart valve to a heart of a patient (see Abstract) using a balloon catheter (see paragraphs [0070]). Dehdashtian teaches deflating the balloon of the delivery system after deploying the prosthetic valve; and withdrawing the delivery system shaft along with the balloon out from the patient's vasculature (see paragraph [0059]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Bialas to include deflating the balloon of the delivery system after deploying the prosthetic valve; and withdrawing the delivery system shaft along with the balloon out from the patient's vasculature, as by doing so is common in the art after implanting the prosthetic valve into the heart of the patient as taught by Bialas (see paragraph [0059]).
Regarding Claim 19, Bialas as modified discloses the method of claim 18.
Bialas fails to disclose wherein the inserting the introducer sheath includes inserting the introducer sheath in one of, a carotid artery, sub-clavian artery or axillary artery.
Dehdashtian teaches wherein the inserting the introducer sheath includes inserting the introducer sheath in one of, a carotid artery, sub-clavian artery or axillary artery (see paragraph [0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Bialas to include inserting the introducer sheath includes inserting the introducer sheath in one of, a carotid artery, sub-clavian artery or axillary artery, as by doing so is common in the art to deliver a prosthetic valve as taught by Bialas (see paragraph [0060]).
Regarding Claim 20, Bialas as modified discloses the method of claim 18.
Bialas fails to disclose wherein the inserting the introducer sheath includes inserting the introducer sheath through one of, apex of the heart for trans-apical implantation route or vein and crossing over into aorta using trans-caval implantation route.
Dehdashtian teaches wherein the inserting the introducer sheath includes inserting the introducer sheath through one of, apex of the heart for trans-apical implantation route or vein and crossing over into aorta using trans-caval implantation route (see paragraph [0060] denoting that the delivery device enters through the left ventricular apex “transapical” route).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Bialas to inserting the introducer sheath includes inserting the introducer sheath through one of, apex of the heart for trans-apical implantation route or vein and crossing over into aorta using trans-caval implantation route, as by doing so is common in the art to deliver a prosthetic valve as taught by Bialas (see paragraph [0060]).
Allowable Subject Matter
Claims 2, 3, 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Reasons for indicating allowable subject matter:
Regarding Claim 2, the following is an examiner’s statement of reasons for allowance: The prior art fails to disclose or suggest, in combination with other limitations recited in the claims, drawing horizontal and vertical center-lines on a virtual circle drawn by the software in the image of the mid-SoV and identifying the intersection of these center-lines as "geometric nodule of sinuses" (GNS), drawing a line through the GNS to a geometric mid-point of any one of Right Coronary Cusp (RCC), Left Coronary Cusp (LCC) or Non- Coronary Cusp (NCC); and measuring an angle formed between the line drawn at (c) and the horizontal center-line that extends on right hand side of the GNS as the AoCA.
Closest Prior Art:
US 20230190466 A1 (hereafter –Biaslas--):
Regarding Claim 2, Bialas discloses the method of claim 1 wherein, the method of determining the AoCA consists of: examining anatomy of a patient's aortic root which houses the native aortic valve and capturing a transverse cross-sectional image of mid-SoV in an imaging software (see paragraph [0464]).
Biaslas fails to disclose drawing horizontal and vertical center-lines on a virtual circle drawn by the software in the image of the mid-SoV and identifying the intersection of these center-lines as "geometric nodule of sinuses" (GNS), drawing a line through the GNS to a geometric mid-point of any one of Right Coronary Cusp (RCC), Left Coronary Cusp (LCC) or Non- Coronary Cusp (NCC); and measuring an angle formed between the line drawn at (c) and the horizontal center-line that extends on right hand side of the GNS as the AoCA.
Regarding Claim 15, the following is an examiner’s statement of reasons for allowance: The prior art fails to disclose or suggest, in combination with fails to disclose the step of crimping of the prosthetic valve being a balloon expandable prosthetic valve includes: placing a crimper on a preparation table with an iris opening in an open position, wherein the angle markings are in the form of at least one of degrees or clock angles and identifying an angle marking that corresponds to AoCA; placing the prosthetic valve at least partially across the iris opening of the crimper such that any one of the commissures of the prosthetic valve is aligned to the identified angle marking on the crimper that corresponds to AoCA, placing a balloon of the delivery system across the prosthetic valve held inside the iris opening of the crimper, crimping the prosthetic valve on the balloon of the delivery system either fully or partially maintaining the position of one of the commissures of the prosthetic valve aligned to the identified angle marking on the crimper that corresponds to the AoCA and the aligner/s face upwards during the entire crimping process, and opening the iris opening of the crimper and removing the balloon with the partially or fully crimped prosthetic valve from the iris opening of the crimper.
Closest Prior Art:
US 20230190466 A1 (hereafter –Biaslas--):
Regarding Claim 15, Bialas discloses the method of claim 1, wherein the crimper consists of angle markings on at least one of its sides (see also paragraph [0395] denoting the alignment member can have other configurations, such as a recess or other alignment feature that is configured to mate with a corresponding mating interface of the crimping device), wherein the outer shaft of the delivery system is marked with aligner/s (see annotated delivery system, outer shaft, and aligners in Figures 9-11 above, see also paragraph [0206]), such that the said aligner/s face upwards (see paragraphs [0234] and [0249] denoting the marker can be facing upwards, see also paragraphs [0465], [0469], [0471] denoting that the method includes rotating of the shaft so that the marker is centered along the guidewire and visible in the imaging, “up” meaning visible to the imaging),
Bialas fails to disclose the step of crimping of the prosthetic valve being a balloon expandable prosthetic valve includes: placing a crimper on a preparation table with an iris opening in an open position, wherein the angle markings are in the form of at least one of degrees or clock angles and identifying an angle marking that corresponds to AoCA determined as per claim 2; placing the prosthetic valve at least partially across the iris opening of the crimper such that any one of the commissures of the prosthetic valve is aligned to the identified angle marking on the crimper that corresponds to AoCA, placing a balloon of the delivery system across the prosthetic valve held inside the iris opening of the crimper, crimping the prosthetic valve on the balloon of the delivery system either fully or partially maintaining the position of one of the commissures of the prosthetic valve aligned to the identified angle marking on the crimper that corresponds to the AoCA and the aligner/s face upwards during the entire crimping process, and opening the iris opening of the crimper and removing the balloon with the partially or fully crimped prosthetic valve from the iris opening of the crimper.
Closest Prior Art:
US 20230190466 A1 (hereafter –Biaslas--):
Regarding Claim 32, Biaslas discloses the method of claim 1.
Biaslas fails to disclose the step of crimping the prosthetic valve being a self-expandable prosthetic valve with one of the commissures of the prosthetic valve aligned to at least one of the loops or eyelets on one of the ends of the frame of the prosthetic valve, includes: identifying the AoCA, determined according to claim 2, on the angle markings on at least one of the sides of the confirmation gauge, wherein the angle markings are in the form of at least one of degrees or clock angles, locking a holder on the intermediate shaft of the delivery system using a locking mechanism wherein, the holder is located on the intermediate shaft of the delivery system, and wherein the holder is provided with a plurality of tabs or paddles or receptacle areas, inserting a distal end of the delivery system in the central opening of the confirmation gauge from one side of the confirmation gauge such that a portion of the outer shaft and the holder protrude out from the other side of the confirmation gauge and the delivery system is oriented such that the aligner/s provided on the outer shaft of the delivery catheter face upwards, unlocking the holder and rotating it on the intermediate shaft such that one of the tabs/paddles or receptacle areas on the holder is aligned with the identified AoCA marking on the confirmation gauge, locking the holder on the distal end of the intermediate shaft in this position, crimping the prosthetic valve on the inner lumen between the distal end of the holder and proximal end of a tip using a loading system in such a manner that the loop/eyelet on the frame of the prosthetic valve that is aligned to one of the commissures of the prosthetic valve is engaged to the tab/paddle or the receptacle on the holder that is aligned to the identified angle marking on the confirmation gauge that corresponding to the AoCA, moving the outer shaft or the retainer sheath of the delivery system over to cover the crimped valve and the holder to retain the crimped valve in this position in radially collapsed condition.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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