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 .
Response to Amendment
This office action is responsive to the amendment filed on 06/23/2026. As directed by the amendment: claims 1, 6-9, 11, 14 have been amended. Thus, claims 1-21 are presently pending in the application.
Response to Arguments
Applicant argues on page 6, the prior art Krag does not teach markers that vibrate in response to an ultrasound signal but instead vibrate following implantation. The examiner respectfully disagrees. Krag teaches a marker 30 emits radio frequency RF signal 44 in response to at triggering signal 46, various energy sources may be used for triggering signal 46, including ultrasound frequency energy (see paragraph [0064]), the incoming ultrasound signal is reflected off the marker as an ultrasound signal, the reflected signal produces a vibration of the marker to enhance the imageability of the marker (paragraph [0068]).
Applicant’s argument on page 7, the prior art von Oepen recites echo markers 710a provided by forming an annular groove in the outer surface of the valve cover 84 and placing a layer of echogenic or radiopaque material within the groove. Therefore, von Oepen et al. does not expressly disclose the new limitation a body defining a plurality of cutouts, a plurality of positional markers positioned on the body defined by adjacent pair of plurality of cutouts or the plurality of positional markers being positioned between the adjacent pair of cutouts is persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of von Oepen et al. U.S. Publication 2021/0322166 A1 in view of Fischer EP2620111A2 and further in view of Krag et al. U.S. Publication 2004/0138555 A1.
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 3 and 6 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 was amended to include a “body defining a plurality of cutouts” and “a plurality of positional markers i) being defined in part by an adjacent pair of plurality of cutouts, ii) being positioned adjacent the pair of cutouts.” Claim 3 recites the body includes a first plurality of ribs extending from a central region of the body and a second plurality of ribs extending oppositely relative to the first plurality of ribs. However, due to the amendment having a plurality of cutouts, it is unclear if the cutouts form said first and second plurality of ribs on opposite sides of the body or if the cutouts are a distinct structure from the plurality of ribs. Claim 6 further limits claim 3, wherein the positional markers are positioned on at least one of the first or the second plurality of ribs. For examination purposes, the examiner interprets the plurality of cutouts on the body to form said “first and second ribs” and the positional markers are positioned on the ribs.
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.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over von Oepen et al. U.S. Publication 2021/0322166 A1 in view of Fischer EP2620111A2 and further in view of Krag et al. U.S. Publication 2004/0138555 A1.
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Regarding Claim 1, von Oepen et al. discloses a medical device 84, comprising: a body defining a plurality of cutouts 556, 558 (see Figure 13A and annotated Figure 13B, forming slots and openings in the body), the plurality of cutouts forming different sections/regions along the body of the device having different cut patterns (see paragraphs [0088-0089]). However, von Open et al. does not expressly disclose a plurality of positional markers positioned on the body, the plurality of positional markers i) being defined in part by an adjacent pair of cutouts, ii) being positioned between the adjacent pair of cutouts. Fischer teaches a medical device 200 in the same field of endeavor comprising a body 202 having a plurality of cutouts 220 (as seen in Figures 5-8, cutouts forming patterns, paragraph [0028]) on a plurality of rows forming said first rib and second rib (the rows of cutouts 220 forms said ribs) and a plurality of positional markers, square pattern forming echogenic elements placed within the rows of cutouts/ribs of the body 202 (see paragraphs [0028-0029]) for the purpose of having a plurality of echogenic regions extending circumferentially around the body that would allow ultrasound visualization along the circumference of the shaft of the tubular body to aid in the location and orientation of the medical device in the body of a patient to distinguish different sides of the medical device (paragraph [0001-0002] and [0028-0029]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s plurality of cutouts to further include positional markers having echogenic elements as taught by Fischer for the purpose of having a plurality of echogenic regions extending circumferentially around the body that would allow ultrasound visualization along the circumference of the shaft of the tubular body to aid in the location and orientation of the medical device in the body of a patient to distinguish different sides of the medical device. However, von Oepen et al. does not expressly disclose the positional markers having at least one parameter selected such that the plurality of positional markers vibrates, in response to an ultrasound signal, at a resonant frequency. Krag et al. teaches an implantable positional markers in the same field of endeavor comprising positional markers 30 that are implantable and imageable by the imaging system such as an ultrasound system (paragraph [0058]), the markers 30 emits radio frequency RF signal 44 in response to at triggering signal 46, various energy sources may be used for triggering signal 46, including ultrasound frequency energy (see paragraph [0064]), the incoming ultrasound signal is reflected off the marker as an ultrasound signal, the reflected signal produces a vibration of the marker for the purpose of enhancing the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location (paragraph [0068]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s positional marker to have at least one parameter in the form of vibration as taught by Krag et al. for the purpose of having markers that produces tactile feedback in response to ultrasound energy to enhance the detection of the marker and inform the physician of the relative position of the marker and the target location.
Regarding Claim 2, von Oepen et al. discloses wherein the medical device 84 is a valve cover of a delivery device for a prosthetic heart valve 10 (paragraphs [0057], [0065], [0081] and [0098] and as seen in Figures 16A-F and 17).
Regarding Claim 3, von Oepen et al. discloses wherein the body includes: a first plurality of ribs extending from a central region of the body; and a second plurality of ribs extending, oppositely relative to the first plurality of ribs, from the central region of the body (as seen in Figure 13A, von Oepen et al. discloses various cut patterns utilized in the outer sheath, see paragraphs [0018], [0078] and [0088-0089]).
Regarding Claim 4, von Oepen et al. discloses a plurality of slots 558 (see Figure 13A), wherein the slots are positioned between adjacent pair of “ribs”(wherein the examiner interprets the ribs to encompass solid material that does not have any perforation and extends between the cut outs) and a second plurality of slots 556, each of the second plurality of slots being positioned at least partially between an adjacent pair of the second plurality of ribs (as seen in Figure 13 and paragraphs [0088-0089]).
Regarding Claim 5, von Oepen et al. discloses various cut patterns for the outer sheath 82 (valve cover 84 encompasses a distal end of the sheath 82, see paragraph [0057]) having slits, slots, geometric shapes along different sections or regions of the outer sheath for providing flexibility and bending (paragraph [0088—0089]) or to apply radiopaque material to render the region visible under fluoroscopy (paragraph [0105]). However, von Oepen et al. does not expressly disclose wherein the first plurality of slots is substantially T-shaped, defining a first crossbar; and the second plurality of slots is substantially T-shaped, defining a second crossbar that is distinct from the first crossbar. It would have been an obvious matter of design choice to have the first and second plurality of slots to have a T-shape since applicant has not disclosed that the T-shape cut outs solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with different geometric shapes to provide flexibility and bending and regions or enhance the visibility under fluoroscopy.
Regarding Claim 6, von Oepen et al. discloses wherein the body includes: a first plurality of ribs extending from a central region of the body; and a second plurality of ribs extending, oppositely relative to the first plurality of ribs (as seen in Figure 13B, the cutouts 556, 558 forms said first plurality of ribs 556 and a second plurality of ribs 558 on the opposite side), from the central region of the body (as seen in Figures 13A-13B, von Oepen et al. discloses various cut patterns utilized in the outer sheath, see paragraphs [0018], [0078] and [0088-0089]). However, von Oepen et al. does not expressly disclose the positional markers positioned on at least one of the first plurality of ribs or the second plurality of ribs. Fischer teaches a medical device 200 in the same field of endeavor comprising a body 202 having a plurality of cutouts 220 (as seen in Figures 5-8, cutouts forming patterns, paragraph [0028]) forming a first plurality of ribs and a second plurality of ribs (see rows of square shaped pattern 220), and a plurality of positional markers, square pattern forming echogenic elements placed within the rows of cutouts/ribs of the body 202 (see paragraphs [0028-0029]) for the purpose of having a plurality of echogenic regions extending circumferentially around the body that would allow ultrasound visualization along the circumference of the shaft of the tubular body to aid in the location and orientation of the medical device in the body of a patient to distinguish different sides of the medical device (paragraph [0001-0002] and [0028-0029]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s plurality of cutouts to further include positional markers having echogenic elements as taught by Fischer for the purpose of having a plurality of echogenic regions extending circumferentially around the body that would allow ultrasound visualization along the circumference of the shaft of the tubular body to aid in the location and orientation of the medical device in the body of a patient to distinguish different sides of the medical device.
Regarding Claim 7, von Oepen et al. does not expressly disclose wherein the plurality of cutout is formed in at least one of the first plurality of ribs or the second plurality of ribs. Fischer teaches a medical device 200 in the same field of endeavor comprising a body 202 having a plurality of cutouts 220 (as seen in Figures 5-8, cutouts forming patterns, paragraph [0028]) on a plurality of rows forming said first rib and second rib (the rows of cutouts 220 forms said ribs) and a plurality of positional markers, square pattern forming echogenic elements placed within the rows of cutouts/ribs of the body 202 (see paragraphs [0028-0029]) for the purpose of having a plurality of echogenic regions extending circumferentially around the body that would allow ultrasound visualization along the circumference of the shaft of the tubular body to aid in the location and orientation of the medical device in the body of a patient to distinguish different sides of the medical device (paragraph [0001-0002] and [0028-0029]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s plurality of cutouts to further include positional markers having echogenic elements as taught by Fischer for the purpose of having a plurality of echogenic regions extending circumferentially around the body that would allow ultrasound visualization along the circumference of the shaft of the tubular body to aid in the location and orientation of the medical device in the body of a patient to distinguish different sides of the medical device.
Regarding Claim 8, von Oepen et al. discloses various cut patterns for the outer sheath 82 (valve cover 84 encompasses a distal end of the sheath 82, see paragraph [0057]) having slits, slots, geometric shapes along different sections or regions of the outer sheath for providing flexibility and bending (paragraph [0088—0089]) or to apply radiopaque material to render the region visible under fluoroscopy (paragraph [0105]). However, von Oepen et al. does not expressly disclose wherein the at least one cutout extends in a direction that is parallel to a longitudinal direction of the medical device. It would have been an obvious matter of design choice to have at least one cutout extends in a direction that is parallel to a longitudinal direction of the medical device for the purpose of enhancing the orientation of the medical device under fluoroscopy to aid in the positioning and delivery of the device (paragraphs [0085-0086], [0100-0101], [0106]).
Regarding Claims 9, 10, von Oepen et al. does not expressly disclose wherein the plurality of markers has at least one resonant frequency such that the plurality of markers vibrates at the resonant frequency in response to an ultrasound imaging procedure and wherein the resonant frequency is in the range of 2- 8MHz. Krag et al. teaches an implantable positional markers in the same field of endeavor comprising positional markers 30 that are implantable and imageable by the imaging system such as an ultrasound system (paragraph [0058]), the markers 30 has a vibration frequency typically 7.5 MHz and depends on the frequency of the ultrasound energy to produce a tactile feedback in the form of a vibration in response to the ultrasound energy for the purpose of enhancing the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location (paragraphs [0068], [0169]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s markers to have at least one resonant frequency, typically 7.5 MHz such that the plurality of markers vibrates at the resonant frequency in response to an ultrasound imaging procedure as taught by Krag et al. for the purpose of having markers that produces tactile feedback in response to ultrasound energy to enhance the detection of the marker and inform the physician of the relative position of the marker and the target location.
Regarding Claim 11, von Oepen et al. discloses wherein at least one physical parameter comprises one or more of: a material of the medical device (the material forming the echo markers on the stent would be a parameter that would affect the visualization and vibration of the medical device, see paragraphs [0101-0102]).
Regarding Claim 12, von Oepen et al. discloses a medical device 84, comprising: a body defining a plurality of cutouts 556, 558 (see Figure 13A and annotated Figure 13B, forming slots and openings in the body). However, von Open et al. does not expressly disclose a plurality of positional markers positioned on the body, the plurality of positional markers i) being defined in part by an adjacent pair of cutouts, ii) being positioned between the adjacent pair of cutouts. Fischer teaches a medical device 200 in the same field of endeavor comprising a body 202 having a plurality of cutouts 220 (as seen in Figures 5-8, cutouts forming patterns, paragraph [0028]), and a plurality of positional markers 230 (square pattern forming echogenic elements, see paragraphs [0028-0029]) being defined in part by an adjacent pair of cutouts 220 (paragraph [0028], circumferential dimpling pattern/cut outs) that are not echogenic for the purpose of having a first echogenic region extending circumferentially around the body and a second region extending adjacent the first echogenic region that would allow ultrasound visualization along the circumference of the shaft of the tubular body to aid in the location and orientation of the medical device in the body of a patient to distinguish different sides of the medical device (paragraph [0001-0002] and [0028-0029]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s plurality of cut outs to further include positional markers having echogenic elements adjacent a plurality of cut outs not having echogenic element for the purpose of having a first echogenic region extending circumferentially around the body and a second region extending adjacent the first echogenic region that would allow ultrasound visualization along the circumference of the shaft of the tubular body to aid in the location and orientation of the medical device in the body of a patient to distinguish different sides of the medical device. However, von Oepen et al. does not expressly disclose the positional markers having at least one parameter selected such that the plurality of positional markers vibrates, in response to an ultrasound signal, at a resonant frequency. Krag et al. teaches an implantable positional markers in the same field of endeavor comprising positional markers 30 that are implantable and imageable by the imaging system such as an ultrasound system (paragraph [0058]), the markers 30 emits radio frequency RF signal 44 in response to at triggering signal 46, various energy sources may be used for triggering signal 46, including ultrasound frequency energy (see paragraph [0064]), the incoming ultrasound signal is reflected off the marker as an ultrasound signal, the reflected signal produces a vibration of the marker for the purpose of enhancing the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location (paragraph [0068]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s positional marker to have at least one parameter in the form of vibration as taught by Krag et al. for the purpose of having markers that produces tactile feedback in response to ultrasound energy to enhance the detection of the marker and inform the physician of the relative position of the marker and the target location. However, von Oepen et al. does not expressly disclose the system comprises an ultrasound imaging apparatus and a probe. Krag et al. teaches a system in the same field of endeavor comprising positional markers that are implantable and imageable by an ultrasound imaging apparatus 34 and a probe 32 (paragraph [0058] and [0068]), the markers 30 produces a tactile feedback in the form of a vibration in response to the ultrasound energy emitted from the probe 32 that is detected using an ultrasound imaging system 34 (paragraph [0068]) for the purpose of enhancing the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location (paragraphs [0068], [0169]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s system to further include an ultrasound imaging apparatus and a probe as taught by Krag et al. for the purpose of having a tool that would emit ultrasound energy to enhance the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location.
Regarding Claim 13, von Oepen et al. does not expressly disclose wherein the probe is a transesophageal echo (TEE) probe. Krag et al. teaches a system in the same field of endeavor comprising positional markers having radiopaque material that reflects echogenic material that reflects ultrasound energy and imageable by an ultrasound imaging apparatus 34 and a probe 32 (paragraph [0058] and [0068]) for emitting ultrasound energy to enhance the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s system to further include a probe as taught by Krag, wherein the probe is a TEE probe to detect the positional echo markers to inform the physician of the relative position of the marker and the target location.
Regarding Claim 14, von Oepen et al. discloses wherein the medical device 84 is a valve cover configured to deliver a prosthetic heart valve 10 (paragraphs [0057], [0065], [0081] and [0098] and as seen in Figures 16A-F and 17). However, in the embodiment used in the rejection above, Figures 13A-13B does not expressly disclose a plurality of markers positioned on the valve cover in a manner that approximately aligns the prosthetic heart valve with native annulus tissue when the valve cover is in a final desired position prior to deployment of the prosthetic heart valve. In an alternative embodiment as seen in Figure 17, von Oepen teaches a plurality of markers 710 is positioned on various positions along the central region of the valve cover 84 (paragraph [0101]) in a manner that approximately aligns the prosthetic heart valve 10 with native annulus tissue 158 when the valve cover is in a final desired position prior to deployment of the prosthetic heart valve 10 (as seen in Figures 16A-16F and paragraphs [0098-0102]) for the purpose of visualizing the delivery device during the delivery procedure to assist in the positioning and deployment of the prosthetic heart valve (paragraphs [0098-0100] and [0102]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s system to further include positional markers positioned on the valve cover that aligns the prosthetic heart valve with native annulus tissue as taught in Figure 17 for the purpose of visualizing the delivery device during the delivery procedure to assist in the positioning and deployment of the prosthetic heart valve.
Regarding Claim 15, von Oepen et al. does not expressly disclose wherein the system excludes a fluoroscopy imaging apparatus. Kraig et al. teaches a system in the same field of endeavor comprising positional markers having radiopaque material that reflects echogenic material and is imageable by an ultrasound imaging apparatus 34 and a probe 32 (paragraph [0058] and [0068]). Furthermore, Kraig et al. teaches using a single imaging modality such as ultrasound, mri, cat or x-ray systems and not fluoroscopy, see paragraph [0058] for the purpose of using a probe that emits ultrasound signals to simultaneously image the medical device and the anatomy of the patient (paragraphs [0058], [0068]) and enhance the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s system to further include a single imaging modality that does not include fluoroscopy, wherein the probe can emit ultrasound signals that allows for the detection of the positional echo markers to inform the physician of the relative position of the marker and the target location.
Regarding Claim 16, von Oepen et al. does not expressly disclose wherein the plurality of positional markers is configured to vibrate in response to the ultrasound signal, at the resonant frequency, when the medical device is at any angular orientation relative to the probe. Krag et al. teaches an implantable positional markers in the same field of endeavor comprising positional markers 30 that emits radio frequency RF signal 44 in response to at triggering signal 46, various energy sources may be used for triggering signal 46, including ultrasound frequency energy (see paragraph [0064]), the incoming ultrasound signal is reflected off the marker as an ultrasound signal, the reflected signal produces a vibration of the marker for the purpose of enhancing the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location (paragraph [0068]). Krag et al. further teaches the positional markers having radiopaque material is imageable by an ultrasound imaging apparatus 34 and a probe 32 (paragraph [0058] and [0068]) for emitting ultrasound energy to enhance the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s system to further include a probe emitting ultrasound signals as taught by Krag for the purpose of detecting the positional echo markers to inform the physician of the relative position of the marker and the target location.
Regarding Claim 17, von Oepen et al. does not expressly disclose wherein the plurality of positional markers is positioned on the body such that a position and/or orientation of the medical device relative to patient anatomy is known from a position and/or orientation of the plurality of positional markers when subjected to the ultrasound signal. Krag et al. teaches an implantable positional markers in the same field of endeavor comprising positional markers 30 that emits radio frequency RF signal 44 in response to at triggering signal 46, various energy sources may be used for triggering signal 46, including ultrasound frequency energy (see paragraph [0064]), the incoming ultrasound signal is reflected off the marker as an ultrasound signal, the reflected signal produces a vibration of the marker for the purpose of enhancing the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location (paragraph [0068]). Krag et al. further teaches the positional markers having radiopaque material is imageable by an ultrasound imaging apparatus 34 and a probe 32 (paragraph [0058] and [0068]) for emitting ultrasound energy to enhance the detection characteristic of the marker to inform the physician of the relative position of the marker and the target location. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify von Oepen’s system to further include a probe emitting ultrasound signals as taught by Krag for the purpose of detecting the positional echo markers to inform the physician of the relative position of the marker and the target location.
Claim(s) 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krag et al. U.S. Publication 2004/0138555 A1 in view of von Oepen et al. U.S. Publication 2021/0322166 A.
Regarding Claim 18, Krag et al. discloses a method of imaging a medical device (in the form of an implantable positional marker) within a patient's body (paragraphs [0058], [0068] and Figure 53), comprising: emitting an ultrasound signal from a probe toward the medical device 30a, 30b, 30c while the medical device is within the patient's body (paragraphs [0013], [0015], [0058-0059]), [0063]); as a result of emitting the ultrasound signal, causing echogenic markers on the medical device to vibrate at a natural frequency (paragraphs [0058], [0064], [0068], [0082]); detecting the vibrations of the medical device (paragraphs [0068], [0114], [0169]); displaying a representation of the medical device on a display device 1310 based on the detected vibrations (as seen in Figure 53 and paragraph [0169], [0171]). However, Kraig et al. does not expressly disclose the echogenic markers are on a medical device. von Oepen et al. discloses a medical device 84, comprising: a body; a plurality of positional markers 710a positioned on the body of the medical device (paragraph [0101] and as seen in Figure 17) for the purpose of aiding in the visualization and proper placement and delivery of the implantable device within the medical device (paragraphs [0101-0102]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Krag’s medical device to include an outer sheath 84 having a body and a plurality of positional markers on the body as taught by von Oepen et al. for the purpose of aiding in the visualization and proper placement and delivery of the implantable device within the medical device.
Regarding Claim 19, Kraig et al. discloses wherein displaying the representation includes displaying an artifact corresponding to a position of the echogenic markers (see Figures 53-61 and paragraph [0170]).
Regarding Claim 20, Kraig et al. discloses wherein the medical device and anatomy of the patient are simultaneously imaged using ultrasound (paragraphs [0097], [0157-0158], [0174]), without using fluoroscopic imaging (Kraig discloses using ultrasound, mri, cat or x-ray systems, see paragraph [0058]).
Regarding Claim 21, Kraig et al. discloses wherein the medical device and anatomy of the patient are simultaneously imaged using ultrasound (Kraig discloses using ultrasound, mri, cat or x-ray systems, see paragraph [0058]), without using a second imaging modality in addition to ultrasound (Kraig discloses using ultrasound, mri, cat or x-ray systems, see paragraph [0058] not two different imaging modalities together).
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 at SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson 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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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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