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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/21/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 14-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim limitation “operating the ultrasound transducer to obtain ultrasound images while simultaneously applying the vacuum...” was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not recite the term “simultaneously” and does not explicitly disclose that the vacuum function and imaging are done simultaneously.
Claims 2-7 are rejected as they depend from rejected claim 1.
Regarding claim 14, the claim limitation “operating the ultrasound transducer to obtain ultrasound images while simultaneously applying the vacuum...” was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not recite the term “simultaneously” and does not explicitly disclose that the vacuum function and imaging are done simultaneously.
Claims 15-20 are rejected as they depend from rejected claim 17.
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 1-2, 4, 7, 14, 15, 17, 20 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 5,951,480), in view of Soykan et al. (WO 2023/130069; hereinafter Soykan).
Regarding claim 1, White discloses an ultrasound imaging guidewire with static central core and tip. White shows a method for obtaining ultrasound images using an ultrasound catheter including an ultrasound transducer (see abstract; 18 in fig. 5), a distal port (see fig. 5) and a proximal port (see fig. 1A, 2A and 7), the ultrasound catheter adapted to provide fluid communication between the distal port and the proximal port (see fig. 1A, 2A and 7; col. 4, line 61 to col. 5, line 29), the method comprising: placing the ultrasound catheter with the distal port of the ultrasound catheter immersed in a patient’s blood (see col. 4, line 61 to col. 5, line 29); applying a vacuum to the proximal port such that the patient’s blood is slowly pulled into the ultrasound catheter and surrounding the ultrasound transducer with the patient’s blood (see col. 4, line 61 to col. 5, line 29), thereby displacing any air disposed near the ultrasound transducer (col. 4, line 61 to col. 5, line 29); and applying the vacuum to the proximal port (see col. 4, line 61 to col. 5, line 29), operating the ultrasound transducer to obtain ultrasound images (see abstract and col. 4, line 61 to col. 5, line 29).
But, White fails to explicitly state operating the ultrasound transducer to obtain ultrasound images while simultaneously applying the vacuum.
Soykan disclose imaging cather with suctioning and teaches operating the ultrasound transducer to obtain ultrasound images while simultaneously applying the vacuum (see par. [0079], [0166], [0168]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of obtaining image while applying vacuum in the invention of White, as taught by Soykan, to provide real-time imaging while suctioning which will aid the user during the procedure by monitoring the suctioning of blood.
The claim limitation “...to minimize acoustic impedance changes in an ultrasound beam path emanating from the ultrasound transducer” and “...such that ultrasound transducer is surrounded by the patient’s blood” are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by White and Soykan is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 2, White and Soykan disclose the invention substantially as described in the 103 rejection above, furthermore, White shows further comprising flushing the ultrasound catheter with saline prior to placing the ultrasound catheter with the distal port of the ultrasound catheter immersed in the patient’s blood (see abstract and col. 4, line 61 to col. 5, line 29).
Regarding claim 4, White and Soykan disclose the invention substantially as described in the 103 rejection above, furthermore, White shows providing the vacuum (abstract and col. 4, line 61 to col. 5, line 29). The examiner notes that the vacuum taught by White will have a vacuum pressure but White and Soykan fail to explicitly state that the pressure up to 100 millimeters mercury (100 mmHg), however, it would have obvious and routine to one of ordinary skill in the art to have the pressure up to 100 mmHg which is enough to suctions blood since it’s held that having optimum or workable ranges is obvious to one of ordinary skill in the art.
Regarding claim 7, White and Soykan disclose the invention substantially as described in the 103 rejection above, furthermore, White shows wherein positioning the ultrasound catheter with the distal port of the ultrasound catheter in fluid communication with the patient’s blood comprises advancing the ultrasound catheter within a guide catheter that is filled with the patient’s blood (see fig. 5 and 6; abstract, and col. 4, line 61 to col. 5, line 29).
Regarding claim 14, White discloses an ultrasound imaging guidewire with static central core and tip. White shows a method for using an ultrasound catheter having an ultrasound transducer see abstract; 18 in fig. 5), a distal port (see fig. 5) and a proximal port (see fig. 5), the ultrasound catheter adapted to provide fluid communication between the distal port and the proximal port (see fig. 1A, 2A and 7; col. 4, line 61 to col. 5, line 29), the method comprising: advancing the ultrasound catheter through a guide catheter positioned within a patient’s vasculature (see col. 4, line 61 to col. 5, line 29), the guide catheter fluidly coupled with the patient’s blood (see col. 4, line 61 to col. 5, line 29), the ultrasound catheter advanced distally such that a distal port of the ultrasound catheter is immersed in the patient’s blood within the guide catheter (see fig. 5, col. 4, line 61 to col. 5, line 29); applying a vacuum to the proximal port such that the patient’s blood is slowly pulled into the ultrasound catheter such that any air near the ultrasound transducer is replaced with the patient’s blood (see col. 4, line 61 to col. 5, line 29) and the ultrasound transducer is surrounded by the patient’s blood (col. 4, line 61 to col. 5, line 29); and operating the ultrasound transducer to obtain ultrasound images (abstract and col. 4, line 61 to col. 5, line 29).
But, White fails to explicitly state operating the ultrasound transducer to obtain ultrasound images while simultaneously applying the vacuum.
Soykan disclose imaging cather with suctioning and teaches operating the ultrasound transducer to obtain ultrasound images while simultaneously applying the vacuum (see par. [0079], [0166], [0168]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of obtaining image while applying vacuum in the invention of White, as taught by Soykan, to provide real-time imaging while suctioning which will aid the user during the procedure by monitoring the suctioning of blood.
The claim limitation “...to minimize acoustic impedance changes in an ultrasound beam path emanating from the ultrasound transducer” and “...such that ultrasound transducer is surrounded by the patient’s blood” are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by White and Soykan is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 15, White and Soykan disclose the invention substantially as described in the 103 rejection above, furthermore, White shows further comprising flushing the ultrasound catheter with saline prior to advancing the ultrasound catheter through the guide catheter (see abstract and col. 4, line 61 to col. 5, line 29).
Regarding claim 17, White and Soykan disclose the invention substantially as described in the 103 rejection above, furthermore, White shows providing the vacuum (abstract and col. 4, line 61 to col. 5, line 29). The examiner notes that the vacuum taught by White will have a vacuum pressure but White and Soykan fail to explicitly state that the pressure up to 100 millimeters mercury (100 mmHg), however, it would have obvious and routine to one of ordinary skill in the art to have the pressure up to 100 mmHg which is enough to suctions blood since it’s held that having optimum or workable ranges is obvious to one of ordinary skill in the art.
Regarding claim 20, White and Soykan disclose the invention substantially as described in the 103 rejection above, furthermore, furthermore shows wherein surrounding the ultrasound transducer with the patient’s blood minimizes acoustic impedance changes in an ultrasound beam path emanating from the ultrasound transducer (see abstract and col. 4, line 61 to col. 5, line 29).
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 5,951,480), in view of Soykan et al. (WO 2023/130069; hereinafter Soykan) as applied to claims 1 and 14 above, and further in view of Cabot (US 2012/0191010).
Regarding claim 3, White and Soykan disclose the invention substantially as described in the 103 rejection above, furthermore, White shows the ultrasound catheter and operating the ultrasound transducer to obtain images (see abstract and col. 4, line 61 to col. 5, line 29), but fails to explicitly state flushing the catheter with saline after the procedure.
Cabot teaches a blood collection catheter and teaches flushing the catheter with saline after the procedure (see par. [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of flushing the catheter with saline after the procedure in the invention of White and Soykan, as taught by Cabot, to clean the catheter.
Regarding claim 16, White and Soykan disclose the invention substantially as described in the 103 rejection above, furthermore, White shows the ultrasound catheter and operating the ultrasound transducer to obtain images (see abstract and col. 4, line 61 to col. 5, line 29) and guide catheter (see fig. 5), but fails to explicitly state flushing the catheter with saline after the procedure.
Cabot teaches a blood collection catheter and teaches flushing the catheter with saline after the procedure (see par. [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of flushing the catheter with saline after the procedure in the invention of White and Soykan, as taught by Cabot, to clean the catheter. The examiner notes that upon incorporating the teaching of Cabot into combined invention of White and Soykan would provide withdrawing the ultrasound cather and flushing the blood. Furthermore, the examiner notes that combined invention of White, Soykan and Cabot also teach subsequently re-advancing the ultrasound catheter through the guide catheter since the ultrasound catheter would have to be reinserted into the guide catheter for re-use of the ultrasound catheter for next procedure.
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 5,951,480), in view of Soykan et al. (WO 2023/130069; hereinafter Soykan) as applied to claims 1 and 14 above, and further in view of Mackin (US 2011/0275894)
Regarding claim 5, White and Soykan disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state a vacuum to the proximal port of the ultrasound catheter comprises attaching a vacuum source to the proximal port.
Mackin shows wherein applying a vacuum to the proximal port of the ultrasound catheter comprises attaching a vacuum source to the proximal port (see 112 in fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a vacuum source in the invention of White and Soykan, as taught by Mackin, to provide a dedicated low pressure suctioning source to easily draw air, fluid through the suction tube from the distal end.
Regarding claim 18, White and Soykan disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state a vacuum to the proximal port of the ultrasound catheter comprises attaching a vacuum source to the proximal port.
Mackin shows wherein applying a vacuum to the proximal port of the ultrasound catheter comprises attaching a vacuum source to the proximal port (see 112 in fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a vacuum source in the invention of White and Soykan, as taught by Mackin, to provide a dedicated low pressure suctioning source to easily draw air, fluid through the suction tube from the distal end.
Claims 6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 5,951,480), in view of Soykan et al. (WO 2023/130069; hereinafter Soykan) as applied to claims 1 and 14 above, and further in view of De Leon et al. (US 2022/0361901; hereinafter De Leon).
Regarding claim 6 and 19, White and Soykan disclose the invention substantially as described in the 103 rejection above, furthermore White shows a syringe (see abstract and col. 4, line 61 to col. 5, line 29), but fails to explicitly state that the a syringe used to apply the vacuum.
De Leon shows a catheter to suction blood using syringe at the proximal port of the catheter to apply the vacuum (see par. [0023]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the affective filling of the claimed invention to have utilized the teaching of using a syringe as the vacuum source in the invention of White and Soykan, as taught by De Leon, to provide a cost-effective vacuum source which can used to suction blood and also can be used as flushing fluid.
Response to Arguments
Applicant’s arguments with respect to prior art rejection have been considered but are moot because the new ground of rejection does not rely on any rejection applied in the prior office action of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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, Anne M 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
Prosecution Insights