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 .
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.
Claim(s) 1, 2, 4, 5, 7, 12, 14, 15, 17, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angel et al. (US 2013/0190803 A1, Jul. 25, 2013) (hereinafter “Angel”).
Regarding claims 1 and 25: Angel discloses An integrated imaging and medical device delivery apparatus comprising: a deployable medical device/an expandable sheathed medical device (fig. 23, [0103] - filter member 516); a central shaft forming an imaging probe lumen and defining a navigation pathway through the apparatus ([0101], [0102]-[0104], fig. 23 - catheter body 512, lumen 530), the navigation pathway allowing an imaging probe to be reciprocally axially movable through the apparatus ([0105]), the apparatus further comprising one or more reference points along the navigation pathway, providing positional information relative to the deployable medical device ([0106]), wherein the navigation pathway includes a visualization section extending from a distal end of the deployable medical device, with the deployable medical device disposed within the visualization section, and the imaging probe disposed within the deployable medical device and configured to obtain images within the visualization section ([0105] - the imaging probe images from within the filter member, which makes the location of the filter member the "visualization section", [0107]); an outer sheath disposed over the deployable medica device and central shaft (fig. 23, [0103] - outer sheath 522); a tapered tip provided at the proximal end of the shaft ([0066] - tip 33 is shown as tapered in at least fig 1; [0069] - atraumatic tip 52 is tapered as shown in figs. 6-7); a reference point located at the tapered tip which defines a proximal limit of the visualization section ([0066], [0069]).
Regarding claim 2: Angel discloses the apparatus according to claim 1, wherein the one or more reference points comprise markers positioned along the length of the navigation pathway ([0066] - markers 24 and 26; [0106]).
Regarding claim 4: Angel discloses the apparatus according to claim 1, wherein in use, the deployable medical device is positioned towards a proximal end of the apparatus with its proximal end spaced from the proximal end of the apparatus by a predetermined amount ([0107] - the bounded region 600).
Regarding claim 5: Angel discloses the apparatus according to claim 1, wherein the imaging probe lumen extends internally of the deployable medical device being retained (fig. 23 and all associated description).
Regarding claim 7: Angel discloses the apparatus according to claim 1, wherein at least part of the central shaft is formed of spectrally transparent material ([0107], [0109]-[0110]).
Regarding claim 12: Angel discloses the apparatus according to claim 1, wherein the deployable medical device comprises a substantially elongate tubular member (figs. 2, 6, 7 – filter member 16; [0078], figs. 14A-H and 15A-H).
Regarding claim 14: Angel discloses the apparatus according to claim 1, further comprising an atraumatic tip provided at the proximal end of the apparatus ([0069] - atraumatic tip 52).
Regarding claim 15: Angel discloses the apparatus according to claim 14, wherein the imaging probe lumen extends into said tip ([0101], [0108] - extending beyond the tip is "into" the tip).
Regarding claim 17: Angel discloses the apparatus according to claim 1, the reference points being provided within the visualization section for enabling measurement and orientation awareness for the imaging probe, wherein the imaging probe at a proximal limit is identified by the one or more reference points and is a defined distance from the deployable medical device ([0066] - markers 24 and 26; [0106]).
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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Angel.
Regarding claim 18: Angel discloses a method of deploying a medical device using an apparatus according to claim 1, the method comprising the steps: inserting an imaging probe into the navigation pathway (claim 4); and advancing the imaging probe to a proximal end of the apparatus for one or more of imaging, road-mapping or measuring a site (claims 5 – 7). Angel further discloses that the imaging system (imaging probe) may be used to guide placement of the filter catheter ([0026], [0102]) and that it can be used with or without translation within the catheter ([0105], claim 5). This is considered to be an implicit disclosure of “either stabilising its position on the apparatus and moving the entire apparatus, or the stabilising the position of the apparatus relative to the site and moving the imaging probe within the apparatus.”
While Angel provides that the apparatus and imaging probe are separate elements which can be moved either together or independently, where the imaging catheter is inserted into the delivery catheter, Angel is silent on an explicit step of inserting the imaging probe at a distal-most extent of said navigation pathway. However, the only possible choices for insertion are at the distal end, the proximal end, or a point between the distal and proximal ends (it is noted here that Angel uses the terms “proximal” and “distal” opposite of the way that they are used in the instant application – [0061]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to insert the imaging probe at the distal-most extent of the navigation in order to provide the imaging probe in the proper location to function as disclosed, and because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense (KSR, 550 U.S. at 421, 82 USPQ2d at 139).
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Angel as applied to claim 18 above, and further in view of Kheradvar (US 2019/0015203 A1, Jan. 17, 2019) (hereinafter “Kheradvar”).
Regarding claim 19: Angel discloses the method of claim 18, including that the intravascular imaging system (imaging probe) may be used to guide placement of the filter catheter within the patient ([0026], [0102]). However, Angel is silent on the details of the placement process including wherein the imaging probe is moved relative to the site by stabilising the position of the imaging probe on the apparatus at a desired position relative to the site and moving the entire apparatus until the imaging probe visualises detectable features prior to deployment of the medical device.
Kheradvar, in the same field of endeavor, teaches a method of positioning a catheter using an intravascular imaging probe comprising stabilising the position of the imaging probe on the apparatus at a desired position relative to the site and moving the entire apparatus until the imaging probe visualises detectable features prior to deployment of the medical device ([0140], [0175]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to perform the placement guidance of Angel as taught by Kheradvar in order to successfully position the apparatus in the proper location for device deployment.
Regarding claim 20: Angel discloses the method of claim 18, including that the intravascular imaging system (imaging probe) may be used to guide placement of the filter catheter within the patient ([0026], [0102]). However, Angel is silent on the details of the placement process including wherein the imaging probe is moved relative to the site by stabilising the position of the apparatus relative to the site and moving the imaging probe within the apparatus to visualise the landing zone of the deployed medical device.
Kheradvar, in the same field of endeavor, teaches a method of positioning a catheter using an intravascular imaging probe wherein the imaging probe is moved relative to the site by stabilising the position of the apparatus relative to the site and moving the imaging probe within the apparatus to visualise the landing zone of the deployed medical device ([0140], [0175]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to perform the placement guidance of Angel as taught by Kheradvar in order to successfully position the apparatus in the proper location for device deployment.
Regarding claim 21: Angel discloses the method of claim 18, including that the intravascular imaging system (imaging probe) may be used to guide placement of the filter catheter within the patient ([0026], [0102]). Angel further discloses moving the imaging probe to the proximal extent defined by said one or more reference points (claim 4, [0106]).
However, Angel is silent on the details of the placement process including locating desired site features using the probe and adjusting the position of the apparatus if required so that the proximal end of the medical device is at a suitable deployment position.
Kheradvar, in the same field of endeavor, teaches a method of positioning a catheter using an intravascular imaging probe including locating desired site features using the probe and adjusting the position of the apparatus if required so that the proximal end of the medical device is at a suitable deployment position ([0136], [0140], claim 6).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Angel to include position refinement as taught by Kheradvar in order to ensure that the filter catheter is in the proper position for deployment.
Claim(s) 1 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kheradvar in view of Angel.
Regarding claim 1: Kheradvar discloses an integrated imaging and medical device delivery apparatus comprising: a deployable medical device (stent 20); a central shaft forming an imaging probe lumen and defining a navigation pathway through the apparatus, the navigation pathway allowing an imaging probe to be reciprocally axially movable through the apparatus ([0170], [0173] - valve delivery catheter; [0196] - "by inserting catheter 300 within delivery system 100 or 200 as previously illustrated" where at least delivery system 200 comprises a "central shaft" catheter body/pusher sleeve 220, [0197]), the apparatus further comprising one or more reference points along the navigation pathway, providing positional information relative to the deployable medical device (markers 212 and 312, [0183], [0196]), wherein the navigation pathway includes a visualization section extending from a distal end of the deployable medical device, with the deployable medical device disposed within the visualization section, and the imaging probe disposed within the deployable medical device and configured to obtain images within the visualization section (fig. 30B, [0197]; the location at which images are acquired by the ivus probe 302 is the intended use of the probe in the absence of any structural limitations; since the probe is configured to image "any and all of the steps of the delivery process (e.g., advancement, positioning, capture, recapture, repositioning, redeployment, withdrawal, etc.)" - see [0140] - and therefore would be capable of obtaining images within the "visualization section"); and an outer sheath disposed over the deployable medical device and central shaft (sheath 210).
Kheradvar is silent on a tapered tip provided at the proximal end of the shaft; a reference point located at the tapered tip which defines a proximal limit of the visualization section.
Angel, in the same field of endeavor, discloses an imaging and medical device delivery apparatus comprising a central shaft with a tapered tip provided at the proximal end of the shaft ([0066] - tip 33 is shown as tapered in at least fig 1; [0069] - atraumatic tip 52 is tapered as shown in figs. 6-7); and a reference point located at the tapered tip which defines a proximal limit of the visualization section ([0066], [0069]). Angel further discloses that the tip marker aids in positional visualization of the distal end of the catheter body ([0066], [0069]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the apparatus of Kheradvar by providing an atraumatic tapered tip as taught by Angel in order to prevent any trauma to the vessel or other tissue during delivery of the apparatus, and to further provide a marker on the tip as taught by Angel in order to assist in positional visualization of the distal end of the catheter body.
Regarding claim 13: Kheradvar further discloses the apparatus according to claim 1, wherein the deployable medical device comprises a stent device (stent 20).
Response to Arguments
Applicant’s arguments regarding prior art rejections of pending claims 1, 2, 4-7, 12-15, 17-21, and 25, filed 11/06/2025, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Regarding Applicant’s request for interview, Applicant is free to contact Examiner at any time to schedule an interview to discuss a specific topic.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached on (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN A PEHLKE/ Primary Examiner, Art Unit 3799