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 .
Status of Claims
Claims 16-24 and 26-35 are pending in this application. Claim 25 is cancelled, Claims 18-21, and 33-35 are withdrawn, and Claims 16-17, 22-24, and 26-32 have been examined on the merits.
Election/Restrictions
Applicant has elected the invention with traverse and the species without traverse.
Applicant’s election without traverse of Species A (Claim 17) from Species Group 1 and Species B (Claim 22) from Species Group 2 in the reply filed on 02/24/26 is acknowledged.
Claims 18-19 and 20-21 are withdrawn with respect to the species from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected species B in Species Group 1 and species A in Species Group 2.
Applicant's election with traverse of claims 16-32 drawn to Invention I in the reply filed on 04/24/2026 is acknowledged. The traversal is on the ground(s) that the common special technical feature making claims 16 and 33 patentable over the prior art is the feature of the vascular access device not being palpated or refraining from palpating.
This is not found persuasive because the technical feature as presented in the unity of invention requirement did not include the common feature of “refraining from palpating the patient” as argued, and thus was not included in the technical feature. The common technical feature included the remote activation of a visualization system of the vascular device to visualize a perimeter of an injection area of the vascular access device and locating the vascular access device by detecting the perimeter of the injection area.
Although the claims as amended show this feature, it is still not a special technical feature in view of Babu. Specifically, Babu teaches refraining from palpating the patient (corresponding disclosure in at least [0040], where when using the device, palpitation is not needed “the practitioner can easily insert a needle into the septum 54 without the need to guess its exact location as may be required using the palpation technique”), the remote activation of a visualization system of the vascular device to visualize a perimeter of an injection area of the vascular access device (corresponding disclosure in at least [0031], where there is a remote activation, or via the NIR laser, which is operated wirelessly, to visualize the perimeter of where the device is “the implanted medical device 50, 150 is formed with at least one light affective area which is configured to affect the IR or NIR light differently compared to the surrounding tissue and the remaining components of the medical device”), and locating the vascular access device by detecting the perimeter of the injection area (corresponding disclosure in at least [0040] and Figure 13, where the device perimeter, or the border of the device is seen in the image “The light sensing device 20 is preferably configured to process the received signals such that the reprojected visible image 26 corresponds to the received light, but is sharper and clearer at the contrasting areas. As seen, the reprojected image 26 will allow the practitioner to clearly identify the location of the port 50, but more specifically the target septum 54”).
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 27 and 31 are objected to because of the following informalities:
In Claim 27, line 2, “LED” should be “light emitting diode (LED)”.
Claim 31 is missing a period. Proper claim format dictates that claims begin with a capital letter and end with a period. See MPEP § 608.01(m).
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.
Claims 16-17, 22-24, and 26-32 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 16 recites the limitation “the vascular access device is sized and shaped not to be palpated when implanted at the site”. It is unclear how the vascular access device is sized and shaped to not be palpated and if there is a specific shape for this function. For purposes of examination, the limitation will be construed as a device that is intended to not be palpated. However, further clarification is required.
All other claims are rejected due to their dependency to the independent claim.
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 16, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babu (US20180035915A1, as disclosed in Applicant’s IDS).
Regarding Claim 16,
Babu teaches a method for locating a vascular access device implanted at a site in a patient (corresponding disclosure in at least [0007], where the method is for locating a vascular device implanted at a site in a patient “The method includes scanning an infrared or near-infrared light over a target area wherein a medical device having at least one light affective area defined thereon is implanted”), comprising:
remotely activating a visualization system of the vascular access device to visualize a perimeter of an injection area of the vascular access device (corresponding disclosure in at least [0031], where there is a remote activation, or via the NIR laser, which is operated wirelessly, to visualize the perimeter of where the device is “the implanted medical device 50, 150 is formed with at least one light affective area which is configured to affect the IR or NIR light differently compared to the surrounding tissue and the remaining components of the medical device”), and
locating the vascular access device by detecting the perimeter of the injection area while refraining from palpating the patient (corresponding disclosure in at least [0040] and Figure 13, where the device perimeter, or the border of the device is seen in the image “The light sensing device 20 is preferably configured to process the received signals such that the reprojected visible image 26 corresponds to the received light, but is sharper and clearer at the contrasting areas. As seen, the reprojected image 26 will allow the practitioner to clearly identify the location of the port 50, but more specifically the target septum 54”), wherein the vascular access device is sized and shaped not to be palpated when implanted at the site (corresponding disclosure in at least [0040], where when using the device, palpitation is not needed “the practitioner can easily insert a needle into the septum 54 without the need to guess its exact location as may be required using the palpation technique”).
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Figure 13 of Babu
Regarding Claim 22,
Babu further teaches wherein the visualization system is further configured to indicate a puncture site within the injection area upon activation (corresponding disclosure in at least [0045], where the puncture site, or when the tip of the catheter is in the area, is indicated upon activation, where activation occurs from the light due to the fluid (injection) “the reprojected image 26.sup.iv will show the position of the tip 152 as the catheter body 154 is advanced through an incision 155 and under the skin of the patient. Additionally or alternatively, the configuration of the light affective area 191 may be selected such that it is absorptively or reflectively distinct from a fluid 160 intended to be passed through the catheter 150 such that both the tip 152 and the presence of the fluid 160 in the catheter are visible on the reprojected image 26.sup.v, as illustrated in FIG. 18”).
Regarding Claim 24,
Babu further teaches wherein the vascular access device is not visible from an outside of the patient when the visualization system is not activated (corresponding disclosure in at least [0031] and Figure 2, where the device, which is implanted, is not visible when not activated, or irradiated by a light source “the implanted medical device 50, 150 is formed with at least one light affective area which is configured to affect the IR or NIR light differently compared to the surrounding tissue and the remaining components of the medical device”).
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Figure 2 of Babu
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.
Claims 17 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Babu (US20180035915A1, as disclosed in Applicant’s IDS) in view of Amin (US20200368513A1, as disclosed in Applicant’s IDS).
Regarding Claim 17, Babu teaches the limitations of Claim 16, but do not teach wherein remotely activating the visualization system comprises sending an activation signal to the vascular access device from one or more of the following: a personal computer, a tablet, a mobile phone, a Smartphone, or a personal digital assistant.
Amin, in a similar field of endeavor, teaches a similar concept (access ports) of wherein remotely activating the visualization system comprises sending an activation signal to the vascular access device from one or more of the following: a personal computer, a tablet, a mobile phone, a Smartphone, or a personal digital assistant (corresponding disclosure in at least [0028], where there is a wireless device for remote activation “The user interface 400 can be integrated with the infusion set 150 or can be a separate device from that of the infusion set 150 and wired or wirelessly coupled thereto… Exemplary user interface devices 400 can include laptops, computer terminals, mobile device, palm top, smartphones, tablets, wearable devices, smartwatches, heads up displays (HUD), Virtual Reality (VR) devices, Augmented Reality (AR) devices, combinations thereof…”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated sending a signal to another device as taught by Amin. One of the ordinary skill in the art would have been motivated to incorporate this because the display presents the information for the user to view.
Regarding Claim 28, Babu teaches the limitations of Claim 22, but does not teach wherein the visualization system comprises an augmented reality device.
Amin, in a similar field of endeavor, teaches a similar concept wherein the visualization system comprises an augmented reality device (corresponding disclosure in at least [0028], where augmented reality is used “The user interface 400 can be integrated with the infusion set 150 or can be a separate device from that of the infusion set 150 and wired or wirelessly coupled thereto… Exemplary user interface devices 400 can include laptops, computer terminals, mobile device, palm top, smartphones, tablets, wearable devices, smartwatches, heads up displays (HUD), Virtual Reality (VR) devices, Augmented Reality (AR) devices, combinations thereof…”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of an augmented reality device as taught by Amin. One of the ordinary skill in the art would have been motivated to incorporate this because augmented reality is another method of displaying the information presented by the device.
Regarding Claim 29, Babu and Amin teach the limitations of Claim 28, and Babu further teaches wherein a location of the vascular access device is projected onto a skin of the patient (corresponding disclosure in at least [0032], where the device is projected on the skin “the light sensing device 20 is further configured to reproject the created image onto the skin using a visible laser”).
Regarding Claim 30, Babu and Ami teach the limitations of Claim 29, and Babu further teaches wherein the injection area of the vascular access device is projected onto a skin of the patient (corresponding disclosure in at least [0043], where the projected area is also the injection area “the reprojected image 26″ represents a power injectable port 50″ in which a single light affective area 91″ encircles the septum 54 to provide an indication of the location and orientation of the septum ”).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Babu (US20180035915A1, as disclosed in Applicant’s IDS) in view of Gage (US20200129749A1).
Regarding Claim 23, Babu teaches the limitations of Claim 22 and further teaches the visualization system and the activation (corresponding disclosure in at least [0031]), but does not teach indication of a first puncture site and a second puncture site.
Gage, in a similar field of endeavor, teaches a similar concept (vessel access) of indication of a first puncture site and a second puncture site (corresponding disclosure in at least [0038], where there is an indication of multiple puncture sites, or a second puncture site “the array includes twelve indicators for cannulation sites at which a hemodialysis needle may be cannulated. A cannulation site corresponds with a cannulation site label”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated indication of a first and second puncture site as taught by Gage. One of the ordinary skill in the art would have been motivated to incorporate this because a user is able to view additional sites in a similar fashion as the first when multiple punctures are needed.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Babu (US20180035915A1, as disclosed in Applicant’s IDS) in view of Jho (US20180154075A1).
Regarding Claim 26, Babu teaches the limitations of Claim 22 and further teaches wherein the visualization system comprises one or more devices arranged along the perimeter of the injection area (corresponding disclosure in at least Figure 3 and [0037], where around the injection area (septum), there are devices arranged along its perimeter “the cap 88 defines a series of light affective areas 91, 93 annularly about the septum”).
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Figure 3 of Babu
Amin does not teach the one or more light emitting devices. Jho, in a similar field of endeavor, teaches a similar concept (access ports) of one or more light emitting devices (corresponding disclosure in at least Figure 7 and [0041], where the device has a light that is emitted “ a plurality of LEDs 44 can be arranged about a bottom perimeter of the ID device 30 such that beams emitted from each LED are transferred to the tissue”).
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Figure 7 of Jho
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the light emitting device as taught by Jho. One of the ordinary skill in the art would have been motivated to incorporate this because the light provides as a form of visualization of the device when implanted.
Regarding Claim 27, Amin teaches the limitations of Claim 22, but does not teach wherein the visualization system comprises a ring shaped LED.
Jho, in a similar field of endeavor, teaches a similar concept of wherein the visualization system comprises a ring shaped LED (corresponding disclosure in at least Figure 7, where the LED is in a ring shape, or circular).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a ring shaped LED. One of the ordinary skill in the art would have been motivated to incorporate this because the light provides as a form of visualization of the device when implanted.
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Babu (US20180035915A1, as disclosed in Applicant’s IDS) in view of Mitchell (US20220015708A1).
Regarding Claim 31, Babu teaches the limitations of Claim 16, but does not teach wherein a height of the vascular access device is less than 10 mm.
Mitchell, in a similar field of endeavor, teaches a similar concept (access ports) of wherein a height of the vascular access device is less than 10 mm (corresponding disclosure in at least [0067], where the device is 6 mm or less, or about 5 mm “the vascular access device 400 can have a height of between about 5 mm to about 50 mm, between about 10 mm and about 30 mm, or about 15 mm”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a vascular access device less than 10 mm in height as taught by Mitchell. One of the ordinary skill in the art would have been motivated to incorporate this because a smaller device enhances the comfortability while being less invasive to the patient.
Regarding Claim 32, Babu and Mitchell teach the limitations of Claim 31, and Mitchell further teaches wherein the height of the vascular access device is 6 mm or less (corresponding disclosure in at least [0067], where the device is 6 mm or less, or about 5 mm “he vascular access device 400 can have a height of between about 5 mm to about 50 mm, between about 10 mm and about 30 mm, or about 15 mm”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Such prior arts include Goldsmith (US20220273312A1), in regards to locating an implanted device, Ferreri (US20070213837A1), in regards to determining an implanted device, and Ellsmere (US20080051722A1), in regards to determining the location of implants.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN KIM whose telephone number is (571)272-1821. The examiner can normally be reached Monday-Friday 6-2 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.E.K./Examiner, Art Unit 3797
/ANNE M KOZAK/Supervisory Patent Examiner, Art Unit 3797
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