DETAILED ACTION
Non-Final Rejection
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/21/2026; 05/15/2026; 11/20/2025; 08/13/2025; 05/08/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The Claim(s) of the instant application are rejected on the ground of nonstatutory double patenting as being unpatentable over the Claim(s) of U.S. Patent No. US 12,287,403 B2 (Sowards et al; hereinafter referred to as Sowards’403); in view of XU (CN 105107067 B) in view of AHN (US 2015/0011887 A1).
Specifically, Claim(s) 1-16 of Sowards’403 are directed to An ultrasound imaging system having near-infrared/infrared detection and method of detecting one or more blood vessels in a target area and generating and projecting a blood vessel visualization depiction over the target area. The present application is directed to the subject matter with substantially similar features. The Claim(s) of the present application are either anticipated by Sowards’403 or are obvious variants of Sowards’403 in view of prior arts provided in the record. Further, the present application is a continuation application of the application for Sowards’403; and since the Claim(s) were not restricted away from the parent application, they are deemed to be directed to obvious variants of the inventions set forth in the parent application.
The following is a limitation-by-limitation comparison (the difference is in the bold text, and substantially similar concept is underlined) to show how the Claim(s) are either anticipated by or unpatentable over the Claim(s) of Sowards (US 12,287,403 B2) hereinafter referred to as Sowards’403.
Instant, Claim(s)
Sowards’403
1. An ultrasound imaging system, comprising:
an ultrasound probe configured to detect one or more blood vessels, the ultrasound probe including an ultrasound generation device operable through a skin contacting side of the ultrasound probe; and
a blood vessel visualization device configured to project a depiction of blood vessel topography within a target area, the blood vessel visualization device coupled to a side of the ultrasound probe adjacent to the skin contacting side, the blood visualization device comprising:
one or more near-infrared/infrared emitters configured to generate infrared/near-infrared waves in the target area;
one or more near-infrared/infrared sensors configured to detect a difference in reflective properties of tissue and blood vessels in the target area; and
one or more visual light projectors configured to project a blood vessel visualization depiction of the blood vessel topography onto the target area.
1. An ultrasound imaging system, comprising:
an ultrasound probe configured to detect one or more blood vessels, the ultrasound probe including an ultrasound generation device defining a bottom side of the ultrasound probe; and
a blood vessel visualization device, the blood vessel visualization device configured to project a depiction of blood vessel topography within a target area, the blood vessel visualization device including:
one or more near-infrared/infrared emitters configured to generate infrared/near-infrared waves within the target area;
one or more near-infrared/infrared sensors configured to detect a difference in reflective properties of tissue and blood vessels within the target area; and
one or more visual light projectors configured to project a blood vessel visualization depiction of the blood vessel topography onto the target area,
wherein each of the one or more near-infrared/infrared sensors, the one or more near-infrared/infrared emitters, and the one or more visual light projectors are: directly coupled to the ultrasound probe, and arranged on a front side of the ultrasound probe, the front side extending upward away from the bottom side in a substantially perpendicular direction with respect to the bottom side.
2. The ultrasound imaging system according to claim 1, wherein the one or more visual light projectors project the blood vessel visualization depiction to one side of the ultrasound probe onto the target area.
2. The ultrasound imaging system according to claim 1, wherein the one or more visual light projectors project the blood vessel visualization depiction to one side of the ultrasound probe onto the target area.
3. The ultrasound imaging system according to claim 1, wherein the one or more near-infrared/infrared emitters and the one or more near-infrared/infrared sensors are located oblique to an ultrasound acoustic stack of the ultrasound probe.
3. The ultrasound imaging system according to claim 1, wherein the one or more near-infrared/infrared emitters and the one or more near-infrared/infrared sensors are located oblique to an ultrasound acoustic stack of the ultrasound probe.
4. The ultrasound imaging system according to claim 1, wherein the blood vessel visualization device includes a console having non-transitory computer readable medium, an energy source and a plurality of logic modules.
4. The ultrasound imaging system according to claim 1, wherein the blood vessel visualization device includes a console having non-transitory computer readable medium, an energy source and a plurality of logic modules.
5. The ultrasound imaging system according to claim 4, wherein the console is in communication with each of the ultrasound probe, the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors and the one or more visual light projectors.
5. The ultrasound imaging system according to claim 4, wherein the console is in communication with each of the ultrasound probe, the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors and the one or more visual light projectors.
6. The ultrasound imaging system according to claim 5, wherein the energy source is in communication with each of the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors, and the one or more visual light projectors.
6. The ultrasound imaging system according to claim 5, wherein the energy source is in communication with each of the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors, and the one or more visual light projectors.
7. The ultrasound imaging system according to claim 6, wherein the energy source is untethered to one or more of the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors, or the one or more visible light projectors.
7. The ultrasound imaging system according to claim 6, wherein the energy source is untethered to one or more of the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors, or the one or more visible light projectors.
8. The ultrasound imaging system according to claim 6, wherein the energy source includes an induction coupling system configured to wirelessly provide energy to the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors or the one or more visible light projectors.
8. The ultrasound imaging system according to claim 6, wherein the energy source includes an induction coupling system configured to wirelessly provide energy to the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors or the one or more visible light projectors.
9. The ultrasound imaging system according to claim 6, wherein the energy source is tethered to the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors or the one or more visible light projectors.
9. The ultrasound imaging system according to claim 6, wherein the energy source is tethered to the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors or the one or more visible light projectors.
10. The ultrasound imaging system according to claim 4, wherein the plurality of logic modules, when executed by one or more processors, are configured to perform operations:
receiving ultrasound data from the ultrasound probe;
correlating a detected location of the one or more blood vessels with a starting location for the blood vessel visualization depiction within the target area;
activating each of the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors, and the one or more visual light projectors;
receiving detected near-infrared/infrared data from the one or more near-infrared/infrared sensors; and
generating and projecting to one side of the ultrasound probe, the blood vessel visualization depiction within the target area.
10. The ultrasound imaging system according to claim 4, wherein the plurality of logic modules, when executed by one or more processors, are configured to perform operations:
receiving ultrasound data from the ultrasound probe;
correlating a detected location of the one or more blood vessels with a starting location for the blood vessel visualization depiction within the target area;
activating each of the one or more near-infrared/infrared emitters, the one or more near-infrared/infrared sensors, and the one or more visual light projectors;
receiving detected near-infrared/infrared data from the one or more near-infrared/infrared sensors; and
generating and projecting to one side of the ultrasound probe, the blood vessel visualization depiction within the target area.
11. The ultrasound imaging system according to claim 1, wherein the ultrasound generation device includes a microelectromechanical systems based device.
11. The ultrasound imaging system according to claim 1, wherein the ultrasound generation device includes a microelectromechanical systems based device.
12. The ultrasound imaging system according to claim 1, further comprising a vascular access device including a visual indicator configured to be activated based upon a vascular access device trajectory relative to a target blood vessel or an identified blood vessel type including an artery or a vein.
12. The ultrasound imaging system according to claim 1, wherein a vascular access device includes a visual indicator configured to be activated based upon a vascular access device trajectory relative to a target blood vessel or an identified blood vessel type including an artery or a vein.
13. A method of detecting one or more blood vessels in a target area and generating and projecting a blood vessel visualization depiction over the target area, comprising: detecting, by ultrasound and near-infrared/infrared electromagnetic waves, blood vessel topography in the target area, wherein detecting by near-infrared/infrared electromagnetic waves includes the electromagnetic waves being emitted from one or more near-infrared/infrared emitters directly coupled to an ultrasound probe and being detected by one or more near-infrared/infrared sensors directly coupled to the ultrasound probe; generating the blood vessel visualization depiction; and projecting to one side of an ultrasound probe, the blood vessel visualization depiction on the target area, wherein: the ultrasound probe includes an ultrasound generation device defining a bottom side of the ultrasound probe, and each of the one or more near-infrared/infrared sensors and the one or more near-infrared/infrared emitters are arranged on a front side of the ultrasound probe, the front side extending upward away from the bottom side in a substantially perpendicular direction with respect to the bottom side.
14. The method according to claim 13, wherein detecting by near-infrared/infrared electromagnetic waves includes the one or more near-infrared/infrared sensors detecting a difference in reflective properties of tissue and blood vessels within the target area.
15. The method according to claim 14, wherein generating the blood vessel visualization depiction includes a console in communication with each of the ultrasound probe, the one or more near-infrared/infrared emitters and the one or more near-infrared/infrared sensors generating the blood vessel visualization depiction using ultrasound data received from the ultrasound probe and electromagnetic wave data received from the one or more near-infrared/infrared sensors.
16. The method according to claim 15, wherein projecting to one side of the ultrasound probe, the blood vessel visualization depiction on the target area includes one or more visual light projectors coupled to the ultrasound probe projecting the blood vessel visualization depiction onto the target area.
Claim(s) 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim(s) 1 of U.S. Patent No. US 12,287,403 B2 (Sowards et al; hereinafter referred to as Sowards’403); in view of XU (CN 105107067 B) in view of AHN (US 2015/0011887 A1).
Referring to instant Claim(s) 1, although the claims at issue are not identical, they are not patentably distinct from each other because they include the same limitations, often with the exact same verbatim language, with only a minor change such as, “the ultrasound probe including an ultrasound generation device operable through a skin contacting side of the ultrasound probe; and the blood vessel visualization device coupled to a side of the ultrasound probe adjacent to the skin contacting side”.
XU include details to this regard in much more detail than the pending claims require. Specifically, XU teaches the ultrasound probe ([0025]: ultrasound probe 203) including an ultrasound generation device ([0011]; [0028]) operable through a skin contacting side of the ultrasound probe (Fig. 3 shows the lower/distial surface of probe 203 positioned against the patient’s skin through ultrasonic conductive gel 301, with the ultrasonic field transmitted through that surface into the body towards veins 302).
Furthermore, AHN teaches the blood vessel visualization device coupled to a side of the ultrasound probe adjacent to the skin contacting side ([0064]; Fig. 6; Clm. 14: “image projector IP is mounted on one side of the ultrasound probe 110, and outputs object information about a surface of a body).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine ultrasound imaging system disclosed in Sowards’403 with the ultrasound probe and ultrasonic blood-vessel positioning functionality taught in XU with a reasonable expectation of success because it would have enabled blood-vessel depth and puncture depth to be determined using ultrasound, thereby improving blood-vessel localization and puncture accuracy as taught by XU (see [0008], [0017]; [0027]).
And further with the ultrasound probe and ultrasonic blood-vessel visualization device mounted on a side of the ultrasound probe adjacent to the skin contacting side taught in AHN with a reasonable expectation of success because it would have enabled object information corresponding to the detected blood vessel to be output directly into the surface of the body at the ultrasound examination location, thereby facilitating visualization of the blood vessel position during vascular access as taught by AHN (see [0064]).
Claim(s) 2-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim(s) 2-12 of Sowards’403; in view of XU in view of AHN (US 2015/0011887.
Referring to instant Claim(s) 2-12, the claims at issue are identical.
Examiner’s Note
Examiner has pointed out particular references contained in the prior art of record in the body of this action for the convenience of the Applicant. However, any citation to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the references should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Applicant, in preparing the response, should consider fully the entire reference as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMIE M N'DURE whose telephone number is (571)272-6031. The examiner can normally be reached on 8AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Isam Alsomiri can be reached on 571-272-6970. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMIE M NDURE/Examiner, Art Unit 3645
/ABDALLAH ABULABAN/Primary Examiner, Art Unit 3645
Prosecution Insights