DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 5/19/2026 has been entered.
Response to Amendment
This office action is responsive to an amendment filed on 4/15/2026. As directed by the amendment, claims 59 and 61-68 were amended, claims 1-58, 60, and 69-77 were cancelled and new claims 78-88 were added. Thus, claims 59, 61-68, and 78-88 are presently pending in this application.
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 59, 61-68, and 78-88 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 pre-AIA the applicant regards as the invention.
Regarding claim 59, the limitation “the emitter” (line 13) is unclear if the emitter is referring to the acoustic wave emitter or the emitter enclosure. For examination purpose, the limitation is being interpreted as --the emitter enclosure--.
Any remaining claims are rejected for their dependency on a rejected base claim.
Allowable Subject Matter
Claims 59, 61-68, and 78-88 are allowable over the prior art.
Claims 59, 61-68, and 78-88 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for indicating allowable subject matter: The closest prior art of record Nguyen (US 2011/0137298), Lee (2006/0206028), Nakagawa (JP 2004215862) do not specifically disclose the claimed apparatus and method as presented in the claims 59, 61-68 and 78-88.
Regarding claim 59, Nguyen discloses a medical device (see entire device in embodiment in figs. 7-14, paragraphs 0057-0067) for treating a calcified tissue occlusion of a body passage of a subject (it is noted that the limitation “for treating a calcified tissue occlusion of a body passage of a subject” is intended use, the medical device of Nguyen is capable of being used for treating a calcified tissue occlusion of a body passage of a subject, Nguyen discloses in figs. 9 and 13 and paragraphs 0063-0066 that the ultrasound transducer is for producing a vibration for ablating tissue, which would be able to treat calcified tissue), the medical device comprising an elongate body (122, fig. 7, paragraph 0058) configured to be inserted into the occluded body passage (the device is disclosed as being inserted into blood vessel and pulmonary venous (PV), therefore, would be capable of being inserted into occluded body passage, see fig. 13, paragraphs 0005, 0069-0070, 0072-0073), the elongate body comprising a distal end (distal end is the end of 122 that is attached to 138, figs. 7, 9 and 13, see the annotated-Nguyen fig. 9 in the Non-final rejection), an acoustic wave emitter (160, 138 and 154, figs. 7, 9 and 13, paragraphs 0059, 0063, 0065, 0066) coupled to the elongate body adjacent to the distal end of the elongate body (see fig. 13), wherein the acoustic wave emitter includes an emitter enclosure (138, figs. 7, 9 and 13, paragraphs 0059, 0061 and 0063-0067), and an acoustic wave generator (160, figs. 7 and 13, paragraphs 0059, 0063, 0065, 0066) received in the emitter enclosure; and a distal tip (distal tip of 180, see the annotated-Nguyen fig. 9 in the Non-final rejection) coupled to the acoustic wave emitter, wherein the distal tip defines a distal end of the medical device (see the annotated-Nguyen fig. 9 in the Non-final rejection), wherein the acoustic wave generator is configured to generate acoustic waves inside the emitter enclosure, wherein the acoustic wave emitter is configured to enable the generated acoustic waves to propagate distally through the emitter enclosure and distal of the distal end of the elongate medical device in use so that the propagated acoustic waves modify calcified tissue of the calcified tissue occlusion that is distal of the distal end of the elongate body (Nguyen discloses in figs. 9 and 13 and paragraphs 0056-0076, that the ultrasound transducer is for producing a vibration for ablating tissue and is configured to be inserted into a blood vessel, which would be able to modify calcified tissue).
PNG
media_image1.png
794
972
media_image1.png
Greyscale
Lee discloses a method and system (system in fig. 1) for treating an occluded body passage of a subject (see claims 53-82, abstract and paragraphs 0022, 0030 and 0060-0080), the method comprising: inserting an elongate medical device (100, fig. 1 and figs. 12A-12B, paragraph 0062) into the occluded body passage (420, fig. 1, paragraph 0060), wherein the elongate medical device has a distal end (see the annotated-Lee fig. 1 above, the distal end formed by the guide wire extending away from 116); positioning an acoustic wave emitter (106 and 114 and 116, fig. 7, paragraphs 0068-0069, 0073-0074 and 0082-0084) of the elongate medical device in the occluded body passage so that the distal end of the elongate medical device faces a calcified tissue occlusion of the occluded body passage (see figs. 8-11, paragraphs 0074-0082, as shown in fig. 9A, the distal end faces calcified tissue occlusion including soft diseased plaque tissue 425 and calcified layer 422, Lee discloses in paragraph 0075 that “The imploding cavitations work best in attacking hard, fragile and inelastic substances such as a calcified tissue. The cavitations will break up the soft, albeit inelastic diseased tissue of a plaque as well” and further discloses that “The flexibility and elasticity of the healthy tissue can easily absorb the imploding pressure with a slight local deflection and/or compression. But a hardened calcified tissue is too stiff to yield to the bending and compression stress of the localized implosion hence will be shattered by it”), wherein the acoustic wave emitter is adjacent the distal end of the elongate medical device and includes an emitter enclosure (see the enclosure formed by 106 and 114, fig. 9A and paragraphs 0062, 0064-0065 and 0069-0070), and an acoustic wave generator (116, paragraphs 0067-0068) received in the emitter enclosure (see figs. 5-9B, as shown, the acoustic wave generator 116 is received in the emitter enclosure); generating acoustic waves inside the emitter enclosure using the acoustic wave generator, wherein the generated acoustic waves propagate distally through the emitter enclosure and distal of the distal end of the elongate medical device (see figs. 9A and 9B, paragraphs 0074-0083, as shown, the emitter enclosure comprises openings that the acoustic waves propagate through), wherein the propagated acoustic waves modify calcified tissue of the calcified tissue occlusion that is distal of the distal end of the elongate body (distal end of elongate body 102, see the annotated-Lee fig .1 above, see figs. 9A-9B and paragraphs 0075-0076, 0078-0082, calcified tissue are being pulverized), Lee discloses that the acoustic wave preserve adjacent non-calcified tissue of the body lumen based on a difference in elasticity between the calcified tissue and surrounding non-calcified tissue (paragraphs 0032-0034 and 0075).
Nakagawa teaches a acoustic wave (shockwave) generator (110, paragraph 0007 of the English translation) positioned within an enclosure (130 and 140, figs. 1-2) and that the shock wave at the diaphragm (140, paragraph 0008) appears to be a spherical shock wave (paragraph 0009, Nakagawa discloses that the shock wave with its center localized on the diaphragm as shown in fig. 3 was observed as a spherical shock wave), however, Nakagawa fails to disclose that the acoustic wave generator is configured to generate spherical acoustic waves inside the emitter enclosure and that the acoustic wave emitter is configured to enable the generated spherical acoustic waves to propagate through the emitter enclosure so that the propagated acoustic waves selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density of modulus of elasticity between the calcified tissue and surrounding non-calcified tissue.
Nguyen, Lee, and Nakagawa fail to disclose the combination of a medical device for treating calcified tissue of a body passage of a subject comprising an acoustic wave emitter coupled to the elongate body and disposed adjacent to the distal end of the elongate body, wherein the acoustic wave emitter includes an emitter enclosure and an acoustic wave generator received in the emitter enclosure, the acoustic wave generator is configured to generated spherical acoustic waves inside the emitter enclosure, wherein the acoustic wave emitter is configured to enable the generated spherical acoustic waves to propagate through the emitter enclosure so that the propagated acoustic waves selectively break up the calcified tissue of the body passage while preserving adjacent non-calcified tissue of the body lumen based on a difference in at least one of density or modulus of elasticity between the calcified tissue and surrounding non-calcified tissue. It is noted, that the term “spherical acoustic waves” is being interpreted as acoustic waves that are generated by the emitter and propagate spherically in all directions from the point source of the emitter, which is consistent with how the art define the term “spherical acoustic waves” and consistent with the disclosure/embodiments of the instant specification. Therefore to modify Nguyen, Lee, and Nakagawa to arrive at the claimed invention would not have been obvious and would be based upon improper hindsight reasoning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TU A VO whose telephone number is (571)270-1045. The examiner can normally be reached Monday-Friday 9:00 AM - 6:00 PM EST.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hawkins (2009/0312768) is cited to show a shockwave emitter for treating calcified tissue.
Watson (5,071,422) is cited to show a laser being used to produce a spherical shockwave to treat calcified tissue.
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, Timothy Stanis can be reached at (571)272-5139. 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.
/TU A VO/Primary Examiner, Art Unit 3785
Prosecution Insights