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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 08/26/2026.
Status of the claims:
Claims 18 – 20, 25 – 38, and 40 – 50 are pending in the application.
Claims 18, 19, 25, 31, 32, and 40 are amended.
Claims 45 – 50 are new.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference character “5” in Figs. 4 and 5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
The objections to claim 21 in the previous action dated 03/05/2026 have been withdrawn in light of the Applicant’s amendments filed 08/26/2026. Specifically, the objection to claim 21 has been withdrawn as claim 21 has been cancelled. However, new objections have been set forth below in light of Applicant’s amendments.
Claim 49 is objected to because of the following informalities:
Claim 49 recites “comprises further comprises” in line 2, however this is not grammatically correct and the Examiner suggests the line be amended to read “further comprises”;
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.
The rejection of claims 39 – 43 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 03/05/2026 have been withdrawn in light of the Applicant’s amendments filed 08/26/2026. Specifically, the rejection of claim 39, regarding the failure to further limit the subject matter from which it depends from, has been withdrawn as claim 39 has been cancelled, and the rejections of claims 40 – 43 have been withdrawn as they are no longer dependent on an indefinite claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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, 25 – 30, and 46 – 49 are rejected under 35 U.S.C. 103 as being unpatentable over Hirszowicz et al. (US 2009/0171278 A1) (previously cited) and in view of Kuroki et al (EP 2,548,593 A1) (cited PDF version attached).
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], [0178 – 0189], and 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);
wherein the dynamic pressure is applied to the hardened material by a balloon (inflatable element 213) (paragraphs [0178 – 0189]);
wherein the balloon (inflatable element 213) is cyclically pressurized (paragraphs [0178 – 0189]) (Examiner’s note: the process of applying the oscillating pressure is repeated, thus is cyclical).
However, Hirszowicz is further silent regarding (i) a means of pressurizing the balloon / inflating the balloon using an elastic diaphragm that is deflected toward and away from a fluid chamber in fluid communication with the balloon.
As to the above, Kuroki teaches, in a similar field of endeavor, a method of applying dynamic pressure to a balloon (balloon 22) via an elastic diaphragm (diaphragm 52) that is deflected toward and away from a fluid chamber (second chamber 48) in fluid communication with the balloon (balloon 22) (abstract, page 11 paragraph [0005] – page 12 paragraph [0001] and Figs. 1 – 4) for the purpose of improving the responsiveness at the time of inflation of the driven device (i.e., the balloon) (i.e., to shorten the time required at the time of inflation and deflation) (page 9 paragraph [0001]).
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 system of Hirszowicz to include the balloon inflation pump with an elastic diaphragm, based on the teachings of Kuroki, for the purpose of allowing the operator to pressurize the balloon and for the purpose of improving the responsiveness at the time of inflation of the driven device (i.e., the balloon) (i.e., to shorten the time required at the time of inflation and deflation) (page 9 paragraph [0001] – Kuroki).
Regarding claim 19, as discussed above, the combination of Hirszowicz and Kuroki teaches the method of claim 18. Additionally, Hirszowicz discloses wherein the modifying comprises fracturing the hardened material (paragraphs [0039], [0108], [0131], [0149], and claim 16).
Regarding claim 25, as discussed above, the combination of Hirszowicz and Kuroki teaches the method of claim 18. Additionally, Hirszowicz discloses wherein cyclical pressurization of the 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, as discussed above, the combination of Hirszowicz and Kuroki teaches the method of claim 18. 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 27, as discussed above, the combination of Hirszowicz and Kuroki teaches the method of claim 18. 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 28, as discussed above, the combination of Hirszowicz and Kuroki teaches the method of claim 18. 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 29, as discussed above, the combination of Hirszowicz and Kuroki teaches the method of claim 18. Additionally, 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, as discussed above, the combination of Hirszowicz and Kuroki teaches the method of claim 18. Additionally, Hirszowicz discloses wherein the elastic conduit (vessel) comprises a vessel (paragraph [0127] and Figs. 7A-F).
Regarding claim 46, as discussed above, it would have been obvious to modify the method / system of Hirszowicz in view of Leveen to incorporate the diaphragm pump of Kuroki. Additionally, Kuroki teaches wherein the diaphragm (diaphragm 52) is deflected toward the fluid chamber (second chamber 48) by a driving pressure applied to a side (side within the first chamber 46 – shown in Fig. 4) of the diaphragm opposite the fluid chamber (second chamber 48) (page 11 paragraph [0008]). Therefore, the combination encompasses the limitations above.
Regarding claim 47, as discussed above, it would have been obvious to modify the method / system of Hirszowicz in view of Leveen to incorporate the diaphragm pump of Kuroki. Additionally, Kuroki teaches wherein the diaphragm (diaphragm 52) has a distal side (side within the second chamber 48 – shown in Fig. 4) facing the fluid chamber (second chamber 48) and a proximal side (side within the first chamber 46 – shown in Fig. 4) facing a gas chamber (first chamber 46), and wherein the diaphragm separates the fluid chamber (first chamber 48) from the gas chamber (second chamber 46) (page 11 paragraph [0008] and Figs. 1 – 4). Therefore, the combination encompasses the limitations above.
Regarding claim 48, as discussed above, it would have been obvious to modify the method / system of Hirszowicz in view of Leveen to incorporate the diaphragm pump of Kuroki. Additionally, the combination makes obvious wherein cyclically pressurizing the balloon (inflatable element 213 of Hirszowicz) comprises contacting the proximal side (side within the first chamber 46 – shown in Fig. 4 of Kuroki) of the diaphragm (diaphragm 52 of Kuroki) with a gas (gas – page 11 paragraph [0008] of Kuroki) flowing through the gas chamber (second chamber 46 of Kuroki) to deflect the diaphragm toward the fluid chamber (first chamber 48 of Kuroki) (Examiner’s note: because Kuroki teaches in paragraphs [0005 – 0009] on page 11, wherein the displacement of the gas in the gas chamber (i.e., the second chamber 46) changes the pressure in the fluid chamber (i.e., the first chamber 46) cyclically pressurizes the balloon of Kuroki, it would be obvious for the modified device to work in the same way such that cyclically pressurizing the balloon of Hirszowicz comprises contacting a gas in the gas chamber with a proximal side of the diaphragm to deflect the diaphragm towards the fluid chamber). Therefore, the combination makes obvious the limitations above.
Regarding claim 49, as discussed above, it would have been obvious to modify the method / system of Hirszowicz in view of Leveen to incorporate the diaphragm pump of Kuroki. Additionally, the combination makes obvious wherein cyclically pressurizing the balloon (inflatable element 213 of Hirszowicz) further comprises exhausting the gas from the gas chamber (second chamber 46 of Kuroki) to deflect the diaphragm (diaphragm 52 of Kuroki) away from the fluid chamber (first chamber 48 of Kuroki) (Examiner’s note: Kuroki teaches in paragraphs [0001 – 0002] on page 12 and paragraph [0001] on page 13, wherein the gas chamber (i.e., the second chamber 46) is connected to a positive pressure pump 4a and a negative pressure pump 4b wherein changing from a positive pressure in the chamber to a negative pressure in the chamber drives the oscillation of the balloon; and the negative pressurizing of the balloon comprises exhausting the gas from the gas chamber. Therefore, because Kuroki teaches the above, it would be obvious for the modified device of Hirszowicz to also encompass wherein the cyclically pressurizing of the balloon comprises exhausting of the gas from the gas chamber via a negative pressure pump that alternates with positive pressure pump). Therefore, the combination makes obvious the limitations above.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hirszowicz et al. (US 2009/0171278 A1) (previously cited) in view of Kuroki et al (EP 2,548,593 A1) (cited PDF version attached), as applied to claim 18 above, and further in view of Leveen et al (US 4,446,867).
Regarding claim 20, as discussed above, the combination of Hirszowicz and Kuroki teaches 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.
Claims 31 – 38 and 40 – 43 are rejected under 35 U.S.C. 103 as being unpatentable over Hirszowicz et al. (US 2009/0171278 A1) (previously cited) and in view of Kuroki et al (EP 2,548,593 A1) (cited PDF version attached) and Leveen et al (US 4,446,867) (previously cited).
Regarding claims 31, 38, 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);
wherein employing the dynamic balloon angioplasty includes pressurizing a balloon (inflatable element 213) (paragraphs [0178 – 0189]).
However, Hirszowicz is silent regarding (i) [claims 31, 38, and 40] wherein the plaque is a calcified plaque / an atherosclerotic calcification and (ii) [claim 31] a means of pressurizing the balloon / inflating the balloon using an elastic diaphragm that is deflected toward and away from a fluid chamber in fluid communication with the balloon.
As to (i), 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.
As to (ii), Kuroki teaches, in a similar field of endeavor, a method of applying dynamic pressure to a balloon (balloon 22) via an elastic diaphragm (diaphragm 52) that is deflected toward and away from a fluid chamber (second chamber 48) in fluid communication with the balloon (balloon 22) (abstract, page 11 paragraph [0005] – page 12 paragraph [0001] and Figs. 1 – 3) for the purpose of improving the responsiveness at the time of inflation of the driven device (i.e., the balloon) (i.e., to shorten the time required at the time of inflation and deflation) (page 9 paragraph [0001]).
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 system of Hirszowicz to include the balloon inflation pump with an elastic diaphragm, based on the teachings of Kuroki, for the purpose of allowing the operator to pressurize the balloon and for the purpose of improving the responsiveness at the time of inflation of the driven device (i.e., the balloon) (i.e., to shorten the time required at the time of inflation and deflation) (page 9 paragraph [0001] – Kuroki).
Regarding claim 32, as discussed above, the combination of Hirszowicz, Leveen, and Kuroki makes obvious the method of claim 31. Additionally, Hirszowicz discloses wherein cyclically pressurizing the balloon comprises employing pressure oscillations with a generalized waveform (paragraph [0178 – 0189]) (Examiner’s note: the oscillations are delivered at a generalized waveform; additionally, the steps of oscillation are repeated and thus are cyclical).
Regarding claim 33, as discussed above, the combination of Hirszowicz, Leveen, and Kuroki 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 Hirszowicz, Leveen, and Kuroki 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, Leveen, and Kuroki 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, Leveen, and Kuroki 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 Hirszowicz, Leveen, and Kuroki 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 Hirszowicz, Leveen, and Kuroki makes obvious the method of claim 31.
However, the current combination of Hirszowicz, Leveen, and Kuroki 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.
Regarding claim 45, as discussed above, it would have been obvious to modify the method / system of Hirszowicz in view of Leveen to incorporate the diaphragm pump of Kuroki. Additionally, Kuroki teaches wherein the diaphragm (diaphragm 52) is deflected toward the fluid chamber (second chamber 48) by a gas pressure applied to a side (side within the first chamber 46 – shown in Fig. 4) of the diaphragm opposite the fluid chamber (page 11 paragraph [0008]). Therefore, the combination encompasses the limitations above.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Hirszowicz et al. (US 2009/0171278 A1) (previously cited) in view of Leveen et al (US 4,446,867) (previously cited) and Kuroki et al (EP 2,548,593 A1) (cited PDF version attached), as applied to claim 31 above, and further in view of Adams (US 9,011,463) (previously cited).
Regarding claim 44, as discussed above, the combination of Hirszowicz, Leveen, and Kuroki makes obvious the method of claim 31.
However, the combination of Hirszowicz, Leveen, and Kuroki 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.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Hirszowicz et al. (US 2009/0171278 A1) (previously cited) in view of Kuroki et al (EP 2,548,593 A1) (cited PDF version attached), as applied to claim 18 above, and further in view of Makower et al (US 2016/0287769 A1).
Regarding claim 50, as discussed above, the combination of Hirszowicz and Kuroki teaches the device of claim 18. Additionally, Hirszowicz teaches in paragraph [0187] wherein the oscillatory manner of the inflation/deflation is preferably at 10Hz; and Kuroki further teaches a pressure sensor (pressure sensor 15) along a fluid communication path between the diaphragm and the balloon and connected to the controller for the purpose of adjusting the inflation/ deflation rate of the balloon (page 18). Therefore, it would have been obvious to modify the system of Hirszowicz to incorporate measuring a fluid pressure along a fluid communication path between the diaphragm and the balloon for the purpose of allowing the operator to adjust the inflation/ deflation rate of the balloon so that the oscillation is within the preferred frequency.
However, the combination is silent regarding (i) determining, based at least in part on the pressure signal, a frequency of the cyclical pressurization and (ii) controlling the cyclical pressurization in accordance with the frequency.
As to the above, Makower teaches a pressure transducer used to measure a flow pressure, plot the pressure/suction waveforms applied to the system, based on the feedback from the pressure sensor the frequency of the cycles and the amplitudes of the pressure can be controlled by the controller (paragraphs [0220 – 0221]). Therefore, Makower teaches using a pressure transducer to determine a frequency of a cycle and amplitudes of the pressure, and controlling the system in accordance with the frequency.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one known method for providing feedback via the pressure transducer (i.e., determining the volume in the flow path) to aid in the control of the device such that the most optimal settings are present for another known method taught and suggested by Makower for using the pressure transducer to aid in determining the frequency of the pulses to aid in the control of the device such that device is operating at the most optimal frequency in the device of Hirszowicz in view of Kuroki since the results of the substitution would have been predictable and resulted in the device operating as intended, such that the pressure transducer provides feedback capable of determining the characteristics of the system in real time and allow the control to adjust said parameters to be in the most optimal ranges. Therefore, the simple substitution of one known element for another producing a predictable result renders the claim obvious. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Response to Arguments
Applicant’s arguments, filed 08/26/2026, with respect to the rejection of claims 18 and 31 under Hirszowicz and, separately, Hirszowicz in view of Leveen have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because neither Hirszowicz nor the combination of Hirszowicz and Leeven teach a diaphragm in the manner claimed. It is noted that a new rejection has been made over Hirszowicz in view of Kuroki and, separately, over Hirszowicz in view of Kuroki and Leeven. The teachings of Kuroki are relied upon for teaching the newly added limitations as discussed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/Andrew Restaino/Primary Examiner, Art Unit 3771
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