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 an amendment filed on 3/9/2026. As directed by the amendment, claims 6-7, and 14 were canceled, claims 1, 11and 15 were amended, and no new claims were added. Thus, claims 1-5, 8-13 and 15 are pending for this application.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1 lines 14-15, “at least one pressure sensor for determining a pressure wave generating pressure” should be changed to --at least one pressure sensor for determining a pressure wave generating pressure (PD)--.
In claim 1 lines 20-21, “depending on the detected pressure wave generating pressure PD” should be changed to --depending on the determined pressure wave generating pressure (PD)-- in order to improve clarity of the claim.
Appropriate correction is required.
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4 and 11-13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Novak (US 2010/0198114) in view of Liu (CN 107669464A) and Lee (KR 20080001518).
Regarding claim 1, Novak discloses (Fig. 1) a pressure wave device for the treatment of a human or animal body comprising:
a pneumatic drive (pneumatic drive 32) for generating a pressure wave for the treatment of the human or animal body
at least one compressor (compressor 34) for generating source gas,
a handpiece (hand-piece 12) into which the source gas can be introduced and by means of which a pressure wave is generated (paragraph [0033]),
a pressure regulating device (comprising control 44 and valve 38) for adjusting a pressure wave generating pressure for generating the pressure wave (paragraphs [0033]-[0034])
wherein the at least one compressor for generating source gas is adjustable in steps to at least two power levels (paragraphs [0033]-[0034]), and
wherein the pressure regulating device (44,38) regulates the pressure wave generating pressure (PD_i) by adapting the source gas pressure (Ps_i) at each power level (paragraphs [0033]-[0034] and [0037]-[0038]).
Novak does not disclose the pressure regulating device has at least one pressure sensor for determining a pressure wave generating pressure and a pressure sensor provided for detecting a source gas pressure and checking the pressure before entry into the hand-piece, wherein depending on the detected source gas pressure and depending on the detected pressure wave generating pressure PD, a pressure wave generating pressure PD is set.
However, Liu teaches (Fig. 1-3) a pneumatic shock device (Abstract) comprising at least one pressure sensor (second pressure sensor 12) for determining a pressure wave generating pressure (determines pressure of outlet end of proportional valve 9, which generates pressure wave, page 4 paragraph 15) and a pressure sensor (pressure sensor 6) provided for detecting a source gas pressure (page 4 paragraph 10) and checking the pressure before entry into the hand-piece (upstream of handpiece 10 and thus checks pressure before entry into handpiece) wherein depending on the detected source gas pressure and depending on the detected pressure wave generating pressure PD, a pressure wave generating pressure PD is set (“the controller is configured to control the working state of the proportional valve 9 according to the output value of the second pressure sensor 12 and the output value of the first pressure sensor 6” page 5 paragraph 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Novak to include at least one pressure sensor for determining a pressure wave generating pressure and a pressure sensor provided for detecting a source gas pressure and checking the pressure before entry into the hand-piece, wherein depending on the detected source gas pressure and depending on the detected pressure wave generating pressure PD, a pressure wave generating pressure PD is set, as taught by Liu, for the purpose of improving safety (page 4 paragraph 10 Liu), and optimizing therapeutic output by ensuring the inputted settings are being correctly translated into the massage output.
Modified Novak discloses a compressor but does not disclose at least two compressors are connected to one motor or each are connected to a one motor for controlling the compressors. However, Lee teaches (Fig. 1-4) a massage system comprising two compressors (compressors 3,4) connected to one motor (motor 2) for controlling the compressors (page 1 paragraph 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of modified Novak to include at least two compressors are connected to one motor or each are connected to a one motor for controlling the compressors, as taught by Lee, for the purpose of reducing the pressure requirement by allowing the air to be spread out by using two compressors instead of one.
Regarding claim 2, modified Novak discloses each power level is determined by a range of pressure wave generating pressure values and frequencies of the activation of the pressure waves (paragraphs [0023] and [0033]-[0034] Novak).
Regarding claim 3, modified Novak discloses selection of power level is made on basis of a table in which respective ranges of pressure wave generating pressure values and frequencies are stored (see Table 1 and paragraphs [0034]-[0035] Novak).
Regarding claim 4, modified Novak discloses the at least one compressor can be switched from a first operating state with first power level to second operating state with second power level in order to set a second pressure wave generating pressure by the pressure regulating device as soon as the pressure wave generating pressure generated in the first operating state is no longer reached at a specific frequency (see paragraphs [0032]-[0035] Novak. Note also that the claim states this limitation “can” be performed, therefore as long as device capable of performing this function (i.e. by a user manually) the limitation is comprehended).
Regarding claim 11, modified Novak discloses a method of treating a human or animal body with pressure waves generated with a pressure wave device according to claim 1, the method comprising steps of
starting the at least one compressor to generate source gas (paragraph [0033] Novak)
passing the source gas from the at least one compressor to the handpiece (paragraph [0033] Novak)
wherein the at least one compressor is set to a discretely controllable operating state to which a discrete power level L is assigned (paragraph [0034]-[0036] Novak)
wherein the pressure wave generating pressure is regulated by adapting a first source gas pressure within the power level L by a pressure regulating device (32, 44) at a certain frequency, (see paragraphs [0034]-[0036] and Table 1 Novak)
and wherein the pressure wave generating pressure is regulated by increasing or decreasing the power level L (see paragraphs [0033]-[0036] Novak).
Regarding claim 12, modified Novak discloses the method further comprises steps of at least partially opening or at least partially closing a pressure regulating device (32,44 of Novak) for passing source gas from the at least one compressor to the handpiece (see paragraph [0037]-[0038] Novak).
Regarding claim 13, modified Novak discloses wherein after a detection of the actually generated pressure wave generating pressure (performed by sensor 12 of Liu) it is checked whether the detected pressure wave generating pressure corresponds to a desired pressure wave generating pressure (comparison of target and instant pressures, see paragraph [0034] Novak) and, depending on a difference between detected pressure wave generating pressure and desired pressure wave generating pressure
a) the state of the pressure regulating device is maintained unchanged, provided that the difference is approximately zero (paragraphs [0030] and [0034] Novak);
b) the pressure regulating device is at least partially opened, provided that the difference is positive (paragraphs [0030] and [0034] Novak), and
c) the pressure regulating device is at least partially closed, provided that the difference is negative (paragraphs [0030] and [0034] Novak).
Regarding claim 15, modified Novak discloses the setting of the power level and/or the regulation of the pressure wave generating pressure can be changed during a treatment (see paragraphs [0033]-[0036] of Novak, performed by user).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Novak (US 2010/0198114) in view of Liu (CN 107669464A) and Lee (KR 20080001518), and further in view of McEwen (US 6,736,787).
Regarding claim 5, modified Novak discloses the pressure regulating device comprises a pressure reducer (valve 38 Novak) or drain valve comprising a valve such as a solenoid valve (valve is energized/deenergized to open and close to create pulsations, see paragraph [0033]-[0034] Novak), but does not disclose wherein the pressure reducer and/or drain valve comprises a proportioning valve.
However, McEwen teaches (Fig. 1-2) the pressure reducer comprises a proportioning valve (proportional valve 28).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure reducer of modified Novak to include a proportioning valve, as taught by McEwen, for the purpose of allowing for adjustment of customizable flow adjustment (as opposed to just turning off, small or larger or intermediate quantities of flow can be delivered, thereby improving customization to the therapeutic plan).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Novak (US 2010/0198114) in view of Liu (CN 107669464A) and Lee (KR 20080001518), and further in view of Micucci (US 2012/0061049).
Regarding claim 8, modified Novak does not disclose a cold trap for collecting cooled, condensed gas is arranged between the at least one compressor and the pressure regulating device. However, Micucci teaches (Fig. 8) a cold trap (condenser 53) for collecting cooled, condensed gas is arranged between the at least one compressor (compressor 52) and the pressure regulating device (high pressure protection switch 98. See positioning between the two in Fig. 8 and paragraph [0077]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of modified Novak to include a cold trap for collecting cooled, condensed gas is arranged between the at least one compressor and the pressure regulating device, as taught by Micucci, for the purpose of providing a cooling effect to user (paragraph [0077] Micucci), thereby improving therapeutic outcome.
Claims 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Novak (US 2010/0198114) in view of Liu (CN 107669464A) and Lee (KR 20080001518), and further in view of Jung (KR 101297373).
Regarding claim 9, modified Novak does not disclose a relief or drain valve provided between the at least one compressor and pressure regulating device for discharging an overpressure of the source gas.
However, Jung teaches (Fig. 1-4) a relief or drain valve (safety valve 114) provided between the at least one compressor and pressure regulating device (see positioning of valve 114 between compressor 110 and pressure regulating valve 1354 in Fig. 2 and 4) for discharging an overpressure of the source gas (see paragraph [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify device of modified Novak to include a relief or drain valve provided between the at least one compressor and pressure regulating device for discharging an overpressure of the source gas, as taught by He, for the purpose of preventing pressure from being too high and to allow the pressure in the storage portion to be kept constant (paragraph [0040] Jung).
Regarding claim 10, modified Novak does not disclose the pressure wave device can be vented by means of a controllable venting valve.
However, Jung teaches (Fig. 1-4) the pressure wave device can be vented by means of a controllable venting valve (safety valve 114).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of modified Novak such that the pressure wave device can be vented by means of a controllable venting valve, as taught by Jung, for the purpose of preventing pressure from being too high and to allow the pressure in the storage portion to be kept constant (paragraph [0040] Jung).
Response to Arguments
Applicant's arguments filed 3/9/2026 have been fully considered but they are not persuasive.
Regarding rejection of claim 1, applicant argued (page 7 paragraphs 2-3 Remarks) that while Liu suggests sensors for safety purposes, Applicant’s recitation requires two sensors at two specific, distinct locations, one at a pressure regulation device and a second at the gas generation source. Applicant further argues there is no motivation in the cited art to complicate Novak’s device with multiple sensors, as one of ordinary skill would generally avoid adding components that increase manufacturing costs and system complexity unless a specific problem is addressed, and the prior art does not suggest that observing pressure at both the source and the regulation device would provide any benefit, whereas the present claim uses this specific data to optimize pressure generation in real-time.
Examiner respectfully disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as stated by Applicant, Liu teaches providing two sensors at two different locations for the purpose of improving safety (page 4 paragraph 10 Liu), and optimizing therapeutic output by ensuring the inputted settings are being correctly translated into the massage output.
In response to Applicant' s argument that “there is no motivation to complicate Novak’s deice with multiple sensors”, it is noted that a teaching away requires a reference to actually criticize, discredit, or otherwise discourage investigation into the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). It has been further instructed that the Examiner will not read into a reference a teaching away from a process where no such language exists. See DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006). In this case, nothing in Novak suggests this would criticize, discredit, or otherwise discourage investigation into the claimed solution, and the teaching reference Liu provides motivation for the combination (for the purpose of improving safety (page 4 paragraph 10 Liu)).
Applicant further argued (page 7 paragraphs 4-5 Remarks) that the core of the recited invention lies in the feature where the control loop acts on the source gas pressure based on feedback from both sensors, and none of the cited documents address a shockwave apparatus where the regulation device maintains stability by adapting the source gas pressure at each power level.
Examiner respectfully disagrees, as this feature is taught by the Liu reference, which is directed to a pneumatic shock wave apparatus, see full rejection above.
Applicant further argued (page 7 paragraph 6 Remarks) that Examiner relies on Lee to teach two compressors however Lee relates to a simple massage device which is fundamentally different from a high-precision, projectile-driven pneumatic shockwave device, where the mechanical loads and precision of a medical pressure wave device are not comparable to those of a massage tool, so one of ordinary skill would not look to the field of massage appliances to solve complex pressure-stabilization problems in medical ballistic therapy.
Examiner respectfully disagrees.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the invention is a high-precision, projectile-driven pneumatic shockwave device) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Lee is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Lee is reasonably pertinent to the particular problem with which the inventor was concerned, that being distributing the power and functions of the invention through two compressors instead of only relying on one compressor to perform all functions.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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