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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/15/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 01/15/2026.
Status of the claims:
Claims 18 – 44 are pending in the application.
Claims 18, 24 - 29, 31, and 33 – 37 are amended.
Claim Objections
Claim 21 is objected to because of the following informalities:
Claim 21 recites “wherein applying dynamic pressure” in line 1, although the line is understood by the Examiner to mean “the applying of the dynamic pressure”, as the step of “applying dynamic pressure” was defined previously, the Examiner suggests the line be amended to read “wherein the applying of the dynamic pressure” for the purpose of maintaining consistent language throughout the claims;
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 39 – 43 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.
A broad limitation together with a narrow limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 31 recites the broad recitation “the calcification present in a wall of a vessel”, and claim 39 also recites “the calcified plaque is present in a vessel” which is the narrower statement of the limitation. Claim 39 is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 40 – 43 are rejected as being indefinite for being dependent on an indefinite 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.
Examiner’s note: it should be understood that oscillation is defined as “a series of pulses”, therefore, under BRI the Examiner is reading the claimed “pulses” to mean “oscillations”. It should be noted that if Applicant is intending for “pulses” to be different than “oscillations”, then Applicant’s disclosure would not have support for the claimed “high frequency-pressure pulses”, “the pulses including a low-pressure phase” and “the pulses including a high-pressure phase”, etc..
Claims 18, 19, and 21 – 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirszowicz et al. (US 2009/0171278 A1) (PGPUB version of previously cited Patent).
Regarding claim 18, Hirszowicz discloses a method of modifying hardened material (atheromatous plaque / occlusion 70,270) embedded within an elastic conduit (vessel) (paragraphs [0093], [0149], claim 16), the method comprising:
applying dynamic pressure (oscillating pressure / oscillatory cycle) to the hardened material (atheromatous plaque / occlusion 70,270) to modify the hardened material (atheromatous plaque / occlusion 70,270) within a wall of the elastic conduit (vessel) (paragraphs [0002], [0011], [0093], [0108 – 0109], [0127 – 0136], [0149], [0179 – 0189]) (Examiner’s note: as stated in paragraph [0093] the method of Hirszowicz is for disrupting (i.e., modifying) vascular occlusions, particularly in cases of CTO (chronic total occlusion); and as stated in paragraph [0002] CTO is caused by an intravascular lesion comprising atheromatous plaque. Moreover, atheromatous plaque is formed within the wall of the vessel. Therefore, Hirszowicz discloses modifying hardened material within a wall of the vessel).
Regarding claim 19, Hirszowicz discloses wherein the modifying comprises fracturing the hardened material (paragraphs [0039], [0108], [0131], [0149], and claim 16).
Regarding claim 21, Hirszowicz discloses wherein applying dynamic pressure (oscillating pressure / oscillatory cycle) to the hardened material (atheromatous plaque / occlusion 70,270) comprises cyclical loading (paragraphs [0108], [0131], and Figs. 7D,E).
Regarding claim 22, Hirszowicz discloses wherein the cyclical loading comprises subjecting the hardened material to an oscillatory stress (paragraphs [0108], [0131], and Figs. 7D,E).
Regarding claim 23, Hirszowicz discloses wherein the oscillatory stress comprises a peak stress in the hardened material's (atheromatous plaque / occlusion 70,270) plastic deformation zone (paragraphs [0039], [0149], and claim 16) (Examiner’s note: the “plastic deformation zone” is the localized region within a material where stress has exceed the yield strength, resulting in permanent damage; and as discussed in the paragraphs listed above, the occlusion is fractured which is permanent, non-reversible damage. Therefore, the oscillatory stress comprises a peak stress for the occlusion’s plastic deformation zone).
Regarding claim 24, Hirszowicz discloses wherein the dynamic pressure (oscillating pressure) is applied to the hardened material (atheromatous plaque / occlusion 70,270) using a balloon (inflatable element 213) (paragraphs [0178 – 0189]).
Regarding claim 25, Hirszowicz discloses wherein the oscillating balloon imparts high-frequency pressure pulses (oscillating pressure) to the hardened material (atheromatous plaque / occlusion 70,270) (paragraphs [0178 – 0189]), (Examiner’s note: it should be understood that a series of pulses creates an oscillation. Therefore, the high-frequency pressure oscillations of Hirszowicz is comprised of high-frequency pressure pulses).
Regarding claim 26, Hirszowicz discloses wherein the high- frequency pressure pulses (oscillating pressure) include a low-pressure phase (step vii – paragraph [0186]) and a high- pressure phase (step vi – paragraph [0185]) (paragraphs [0185 – 0187]).
Regarding claim 27, Hirszowicz discloses wherein the low- pressure phase of oscillations comprises employing a balloon pressure (2 atm) ranging from 1-2 atm (paragraph [0186]).
Regarding claim 28, Hirszowicz discloses wherein the high-pressure phase comprises employing a balloon pressure (4 atm) ranging from above 2 atm to 25 atm (paragraph [0185]).
Regarding claim 29, Hirszowicz discloses wherein the oscillating balloon oscillates at high-frequency pressure pulses have a frequency ranging from 2- 40Hz (20Hz) (paragraph [0187]).
Regarding claim 30, Hirszowicz discloses wherein the elastic conduit (vessel) comprises a vessel (paragraph [0127] and Figs. 7A-F).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 20 and 31 – 43 are rejected under 35 U.S.C. 103 as being unpatentable over Hirszowicz et al. (US 2009/0171278 A1) (PGPUB version of previously cited Patent), as applied to claim 31 above, and further in view of Leveen et al (US 4,446,867).
Regarding claim 20, as discussed above, Hirszowicz discloses the method of claim 18.
However, Hirszowicz is silent regarding (i) wherein the hardened material is a calcified plaque.
As to the above, Leveen teaches, in the same field of endeavor, a method of fracturing a calcification (arteriosclerosis) within an affected artery or vein vessel via dynamic pressure (pulsed pressure) (abstract and col. 2 lines 54 – 65).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Hirszowicz to incorporate treating a calcified plaque a vessel wall, based on the teachings of Leveen, as calcified plaques are known to form within said vessels which are known to be treated by a dynamic pressure balloon, and for the purpose of breaking up said calcified plaques in order to prevent further complications within the body.
Regarding claims 31, 38, 39, and 40, Hirszowicz discloses a method of fracturing an occlusion of a subject (abstract, paragraphs [0093], [0108], [0127], and Figs. 7A-F), the method comprising:
employing dynamic balloon angioplasty (oscillating pressure / oscillatory cycle of balloon catheter 10) to fracture the occlusion (atheromatous plaque / occlusion 70) present within a wall of a vessel of the subject (vessel) and wherein (paragraphs [0002], [0011], [0093], [0108 – 0109], [0127 – 0136], and Figs. 7D,E) (Examiner’s note: as stated in paragraph [0093] the method of Hirszowicz is for disrupting (i.e., modifying) vascular occlusions; and as stated in paragraph [0002] CTO is caused by an intravascular lesion comprising atheromatous plaque. Moreover, atheromatous plaque is formed within the wall of the vessel. Therefore, Hirszowicz discloses fracturing a calcified plaque within a wall of the vessel).
However, Hirszowicz is silent regarding (i) wherein the plaque is a calcified plaque / [claim 40] an atherosclerotic calcification.
As to the above, Leveen teaches, in the same field of endeavor, a method of fracturing a calcification (arteriosclerosis) within an affected artery or vein vessel via dynamic pressure (pulsed pressure) (abstract and col. 2 lines 54 – 65).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Hirszowicz to incorporate treating a calcified plaque a vessel wall, based on the teachings of Leveen, as calcified plaques are known to form within said vessels which are known to be treated by a dynamic pressure balloon, and for the purpose of breaking up said calcified plaques in order to prevent further complications within the body.
Regarding claim 32, as discussed above, the combination of Hirszowicz and Leveen makes obvious the method of claim 31. Additionally, Hirszowicz discloses wherein the dynamic balloon angioplasty comprises employing pressure oscillations with a generalized waveform (paragraph [0178 – 0189]) (Examiner’s note: the oscillations are delivered at a generalized waveform).
Regarding claim 33, as discussed above, the combination of Hirszowicz and Leveen makes obvious the method of claim 31. Additionally, Hirszowicz discloses wherein the pressure oscillations comprise high-frequency pressure pulses (paragraphs [0178 – 0189]) (Examiner’s note: it should be understood that a series of pulses creates an oscillation. Therefore, the high-frequency pressure oscillations of Hirszowicz is comprised of high-frequency pressure pulses).
Regarding claim 34, as discussed above, the combination of Hirszowicz and Leveen makes obvious the method of claim 31. Additionally, Hirszowicz discloses wherein the high- frequency pressure pulses (oscillating pressure) include a low-pressure phase (step vii – paragraph [0186]) and a high- pressure phase (step vi – paragraph [0185]) (paragraphs [0185 – 0187]).
Regarding claim 35, as discussed above, the combination of Hirszowicz and Leveen makes obvious the method of claim 31. Additionally, Hirszowicz discloses wherein the low- pressure phase of oscillations comprises employing a balloon pressure (2 atm) ranging from 1-2 atm (paragraph [0186]).
Regarding claim 36, as discussed above, the combination of Hirszowicz and Leveen makes obvious the method of claim 31. Additionally, Hirszowicz discloses wherein the high-pressure phase comprises employing a balloon pressure (4 atm) ranging from above 2 atm to 25 atm (paragraph [0185]).
Regarding claim 37, as discussed above, the combination of Hirszowicz and Leveen makes obvious the method of claim 31. Additionally, Hirszowicz discloses wherein the oscillating balloon oscillates at high-frequency pressure pulses have a frequency ranging from 2- 40Hz (20Hz) (paragraph [0187]).
Regarding claims 41 – 43, as discussed above, the combination of Hirszowicz and Leveen makes obvious the method of claim 31.
However, the current combination of Hirszowicz and Leveen is silent regarding (i) [claim 41] wherein the calcified plaque is present in an arterial conduit, wherein the arterial conduit is [claim 42] a coronary artery or [claim 43] a peripheral artery.
As to the above, Leveen teaches, in the same field of endeavor, a method of fracturing a calcification (arteriosclerosis) within an affected artery or vein vessel via dynamic pressure (pulsed pressure) (abstract and col. 2 lines 54 – 65), wherein the calcifications are known to be present in the coronary and peripheral arteries (col. 1 lines 10 – 20).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Hirszowicz to incorporate treating a calcified plaque within an coronary artery and/or a peripheral artery, based on the teachings of Leveen, as calcified plaques are known to form within said vessels which are known to be treated by a dynamic pressure balloon, and for the purpose of breaking up said calcified plaques in order to prevent further complications within the body.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Hirszowicz et al. (US 2009/0171278 A1) (PGPUB version of previously cited Patent) in view of Leveen et al (US 4,446,867), as applied to claim 31 above, and further in view of Adams (9,011,463).
Regarding claim 44, as discussed above, the combination of Hirszowicz and Leveen makes obvious the method of claim 31.
However, the combination of Hirszowicz and Leveen is silent regarding (i) the calcification comprises a calcified valve.
As to the above, Adams teaches, at least in col. 2, lines 4-40; that, similar to angioplasty, a calcified valve may be treated with a shock wave balloon catheter. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Adams, to modify the method of Hirszowicz et al., so that calcification of the valve is fractured. Such a modification would allow valvular and vascular calcification to be treated, so that a patient may have improved blood flow as well as a tissue area prepared for a new, catheter-delivered valve.
Response to Arguments
Applicant's arguments, filed 01/15/2026, directed to claim 18 have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s argument that “Hirszowicz, fails to disclose hardened material within a vessel wall”, the Examiner notes that Hirszowicz teaches, in paragraph [0002], the use of the device to treat an atheromatous plaque material, and atheromatous plaque is formed within the wall of the vessel; therefore, Hirszowicz discloses the hardened material within a vessel wall.
Applicant’s arguments, filed 01/15/2026, with respect to the rejection(s) of claims 20 and 31 under Hirszowicz have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. More specifically, the argument regarding “Hirszowicz, fails to disclose a calcified plaque within a vessel wall” is considered persuasive, as the Examiner agrees that Hirszowicz does not expressly teach wherein the occlusion is calcified. However, upon further consideration, a new ground(s) of rejection is made in view of Hirszowicz in view of Leveen; wherein Leveen is relied upon for teaching the calcified plaque.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771