DETAILED ACTION
This office action is in response to the amendment filed 7/5/2026. As directed by the amendment, claims 12 and 22-24 have been amended, claims 1-11 and 17-18 have been cancelled, and claims 25-29 have been newly added. Thus, claims 12-16 and 19-29 are presently pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a gas treatment arrangement located in line with the mechanism such that at least air exhaled by the patient passes through the gas treatment arrangement before flowing to atmosphere” in claims 12, 22, and 26.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 25 and 29 are objected to because of the following informalities: Claim 25, line 2 and claim 29, line 3 recites, “the external side”; it is suggested to amend the claims to recite –an external side—as it is the first time the limitation is being recited. Appropriate correction is required.
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 of this title, 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.
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 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.
Claim(s) 12-14, 20-22, 24, 26, and 28 s/are rejected under 35 U.S.C. 103 as being unpatentable over Pelerossi et al (2003/0234017) in view of Cegla (2012/0227741).
Regarding claim 12, Pelerossi discloses a respiratory therapy device (1000) having an inlet (201) (patient input end) configured to be breathed by a user (para [0025]), an opening (350) to atmosphere (openings in dial (350) through which expiratory air exits the device) (para [0028]), and a mechanism (400) adapted to be driven by exhalation breathing through the device to produce an oscillating resistance to the exhalation breathing through the device (expiratory-air-driven oscillatory rocker assembly (400) creates an oscillatory positive expiratory air pressure which is applied to the patient during exhalation) (para [0022]), an arrangement comprising a mouthpiece (202) located in line with the mechanism (400) such that at least air exhaled by the patient passes through the mouthpiece (202) before flowing to atmosphere (para [0026]); wherein the mechanism (400) includes a displaceable member (440) (rocker portion) including a rocker arm (445) (para [0029]) configured to be displaced by breathing through the device to produce an alternating resistance to the breathing (para [0022]).
Pelerossi does not disclose the mouthpiece comprises a gas treatment arrangement located in line with the mechanism such that at least air exhaled by the patient passes through the gas treatment arrangement before flowing to atmosphere.
However, Cegla teaches a device including a mouthpiece (6) comprising an inlet through which a user breathes (para [0021]), and a mechanism (22) (second pipe section) driven by breathing through the device to produce an oscillating resistance to breathing through the device (generates an oscillating vibratory behavior) (para [0039]), wherein the mouthpiece includes a filter (28) serving as a gas treatment arrangement such that at least air exhaled by the patient passes through the gas treatment arrangement (28) before flowing through atmosphere) (filter (28) serves to clean the air which flows through it, and to capture and hold back suspended matter or microparticles) (para [0026]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Pelerossi by providing the mouthpiece with a gas treatment arrangement comprising a filter located in line with the mechanism such that at least air exhaled by the patient passes through the gas treatment arrangement before flowing to atmosphere as taught by Cegla in order to clean the air which flows through the device, and to capture and hold back suspended matter or microparticles) (Cegla, para [0026]).
Regarding claim 13, Pelerossi discloses the gas treatment arrangement (202) is located such that both exhaled and inhaled air passes through the gas treatment arrangement (202) (device includes flapper valve arrangement (225) to allow a user to draw air into the device (200) (para [0027]) and patient discharges expiratory air through the device (200) (para [0026]).
Regarding claim 14, the modified Pelerossi’s reference discloses that the gas treatment arrangement includes a filter (28 of Cegla) (Cegla, para [0024]).
Regarding claim 20, the modified Pelerossi’s references discloses that the gas treatment arrangement (28 of Cegla) is located at the inlet of the device (as shown in fig 2 of Pelerossi, mouthpiece (202 of Pelerossi) is disposed at the inlet (201 of Pelerossi) of the device (Pelerossi, para [0026]), and as shown in figs 2-3 of Cegla, gas treatment arrangement (28 of Cegla) is arranged in mouthpiece (6 of Cegla) located at an inlet of the device (Cegla, para [0024]).
Regarding claim 21, the modified Pelerossi’s references discloses the gas treatment arrangement (28 of Cegla) is located in a mouthpiece (6 of Cegla) (Cegla, para [0024]), and the mouthpiece (202 of Pelerossi) is removable (as shown in fig 2 of Pelerossi, mouthpiece (202 of Pelerossi) is shown to be separable from patient input end (201 of Pelerossi)) (Pelerossi, para [0026]).
Regarding claim 22, Pelerossi discloses an apparatus comprising a removable mouthpiece (202), the mouthpiece adapted to be used with a respiratory therapy device (1000) having an inlet (201) (input end) configured to be breathed through by a user (para [0026]), wherein the device (1000) includes an opening (350) to atmosphere (openings in dial (350) through which expiratory air exits the device) (para [0028]), and a mechanism (400) including a driven member (400) (rocker assembly) adapted to be driven by exhalation breathing through the device to produce an oscillating resistance to breathing through the device (expiratory-air-driven oscillatory rocker assembly (400) creates an oscillatory positive expiratory air pressure which is applied to the patient during exhalation) (para [0022]); wherein the mechanism (400) includes a displaceable member (440) (rocker portion) including a rocker arm (445) (para [0029]) configured to be displaced by breathing through the device to produce an alternating resistance to the breathing (para [0022]).
Pelerossi does not disclose the mouthpiece is in line with a gas treatment arrangement located in line with the mechanism such that at least air exhaled by the patient passes through the gas treatment arrangement before flowing to atmosphere.
However, Cegla teaches a device including a mouthpiece (6) comprising an inlet through which a user breathes (para [0021]), and a mechanism (22) (second pipe section) driven by breathing through the device to produce an oscillating resistance to breathing through the device (generates an oscillating vibratory behavior) (para [0039]), wherein the mouthpiece includes a filter (28) serving as a gas treatment arrangement such that at least air exhaled by the patient passes through the gas treatment arrangement (28) before flowing through atmosphere) (filter (28) serves to clean the air which flows through it, and to capture and hold back suspended matter or microparticles) (para [0026]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Pelerossi by providing the mouthpiece with a gas treatment arrangement comprising a filter located in line with the mechanism such that at least air exhaled by the patient passes through the gas treatment arrangement before flowing to atmosphere as taught by Cegla in order to clean the air which flows through the device, and to capture and hold back suspended matter or microparticles) (Cegla, para [0026]).
Regarding claim 24, the modified Pelerossi’s references discloses the gas treatment arrangement (28 of Cegla) is located in the removable mouthpiece (6 of Cegla) (Cegla, para [0024]), and the mouthpiece (202 of Pelerossi) is removable (as shown in fig 2 of Pelerossi, mouthpiece (202 of Pelerossi) is shown to be separable from patient input end (201 of Pelerossi)) (Pelerossi, para [0026]).
Regarding claim 26, Pelerossi discloses an apparatus comprising a removable mouthpiece (202), the mouthpiece adapted to be used with a respiratory therapy device (1000), wherein the device (1000) has an inlet (201) (input end) through which the mouthpiece (202) is configured to be fitted (para [0026]), an opening to atmosphere (output of exhaled breath enters air-flow tube discharge opening (203), which is discharged from the housing (300) through openings in the adjusting dial (350) (para [0030]), and a mechanism (400) includes a displaceable member (440) (rocker portion) having a rocker arm (445) (para [0029]) adapted to be displaced by breathing through the device to produce an oscillating resistance to the exhalation breathing (para [0022]), wherein the inlet (201) is configured to be breathed through by a user through the mouthpiece (202) (para [0027]),
Pelerossi does not disclose a gas treatment arrangement is located in line with the mechanism such that air exhaled by the user is adapted to pass through the gas treatment arrangement before flowing to atmosphere.
However, Cegla teaches a device including a mouthpiece (6) comprising an inlet through which a user breathes (para [0021]), and a mechanism (22) (second pipe section) driven by breathing through the device to produce an oscillating resistance to breathing through the device (generates an oscillating vibratory behavior) (para [0039]), wherein the mouthpiece includes a filter (28) serving as a gas treatment arrangement such that at least air exhaled by the patient passes through the gas treatment arrangement (28) before flowing through atmosphere) (filter (28) serves to clean the air which flows through it, and to capture and hold back suspended matter or microparticles) (para [0026]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Pelerossi by providing the mouthpiece with a gas treatment arrangement comprising a filter located in line with the mechanism such that at least air exhaled by the patient passes through the gas treatment arrangement before flowing to atmosphere as taught by Cegla in order to clean the air which flows through the device, and to capture and hold back suspended matter or microparticles) (Cegla, para [0026]).
Regarding claim 28, the modified Pelerossi’s references discloses the gas treatment arrangement (28 of Cegla) is located in the removable mouthpiece (6 of Cegla) (Cegla, para [0024]), and the mouthpiece (202 of Pelerossi) is removable (as shown in fig 2 of Pelerossi, mouthpiece (202 of Pelerossi) is shown to be separable from patient input end (201 of Pelerossi)) (Pelerossi, para [0026]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pelerossi et al and Cegla as applied to claim 14 above, and further in view of Wood (2010/0319699).
Regarding claim 15, modified Pelerossi discloses a filter.
Modified Pelerossi does not disclose the filter is an electrostatic filter.
However, Wood teaches a filter for a ventilator, wherein the filter (1) is an electrostatic filter comprising an electrostatically charged material (10) (para [0019]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Pelerossi by configuring the filter to be an electrostatic filter as taught by Wood in order to improve the life of the filter material and attract liquid and particles to the filter medium (Wood, para [0011]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pelerossi et al and Cegla as applied to claim 12 above, and further in view of Costella et al (2019/0001187).
Regarding claim 16, modified Pelerossi discloses a gas treatment arrangement.
Modified Pelerossi does not disclose the gas treatment arrangement includes a heat and moisture exchange element.
However, Costella teaches a respiratory therapy device for providing positive expiratory pressure, and in fig 40-41 includes inhalation ports (302) and an exhalation port (304), wherein the device includes a gas treatment arrangement includes a heat and moisture exchange element (HME) (not shown) (para [0116]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Pelerossi by providing the gas treatment arrangement with a heat and moisture exchange element as taught by Costella in order to improve the quality of inhaled air by warming it and utilizing moisture from exhaled breath (Costella, para [0116]).
Claim(s) 19, 23, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pelerossi et al and Cegla as applied to claims 12 and 22 above, and further in view of Poormand et al (2022/0288344).
Regarding claims 19, 23, and 27 modified Pelerossi discloses a gas treatment arrangement.
Modified Pelerossi does not disclose the gas treatment arrangement is located between the mechanism and the opening to atmosphere such that exhaled air flows to the gas treatment arrangement after flowing through the mechanism.
However, Poormand teaches a respiratory device including an exhalation port (26) open to atmosphere (para [0022]), and a gas treatment arrangement comprising a filter (32) for filtration of microbes disposed proximate to the exhalation port (26) (para [0025]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Pelerossi by providing a gas treatment arrangement comprising an antimicrobial filter proximate to the opening to atmosphere as taught by Poormand in order to remove microbes from exhaled respiratory gas before the respiratory gas exits through the opening to atmosphere (Poormand, abstract). The now-modified Pelerossi’s device is considered that gas treatment arrangement is located between the mechanism and the opening to atmosphere such that exhaled air flows to the gas treatment arrangement after flowing through the mechanism, as Poormand teaches that the gas treatment arrangement (32 of Poormand) is disposed proximate to the opening to atmosphere (26 of Poormand) (Poormand, fig 3, para [0025]), and Pelerossi teaches that the opening to atmosphere (350 of Pelerossi) is arranged such that exhaled air flows to the opening (350 of Pelerossi) after flowing through the mechanism (400 of Pelerossi) (Pelerossi, fig 2, para [0028]),and therefore, a gas treatment arrangement disposed proximate the opening to atmosphere would be located between the mechanism and the opening to atmosphere such that exhaled air flows to the gas treatment arrangement after flowing through the mechanism.
Claim(s) 25 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pelerossi et al and Cegla as applied to claims 22 and 26 above, and further in view of Costella et al (2019/0001187) and Martin, Jr. et al (5,992,413).
Regarding claims 25 and 29, modified Pelerossi discloses a gas treatment arrangement comprises a filter.
Modified Pelerossi does not disclose the gas treatment apparatus comprises a heat and moisture exchange element.
However, Costella teaches a respiratory therapy device for providing positive expiratory pressure, and in fig 40-41 includes inhalation ports (302) and an exhalation port (304), wherein the device includes a gas treatment arrangement includes a heat and moisture exchange element (HME) (not shown) (para [0116]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Pelerossi by providing the gas treatment arrangement with a heat and moisture exchange element as taught by Costella in order to improve the quality of inhaled air by warming it and utilizing moisture from exhaled breath (Costella, para [0116]).
The now-modified Pelerossi’s device does not disclose the filter is located on an external side of the heat and moisture exchange element.
However, Martin in fig 2 teaches a heat and moisture exchanger and generator including a filter (34) (antimicrobial filter element) (col 5, ln 28-33) and a heat and moisture exchange element (38) (gas permeable fibrous element is selected to provide for both heat and moisture exchange with gases passing through) (col 7, ln 11-18), and as shown in fig 2, the filter (34) is located at a side of the heat and moisture exchange element (38) that faces an inlet (22) which is located at a patient side of the apparatus.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Pelerossi so that filter is located on an external (patient-facing) side of the heat and moisture exchange element as taught by Martin, as it would be an obvious rearrangement of parts, as the feature of providing the filter on an external patient facing side of the heat and moisture exchange apparatus is known in the art, and it appears that the device would perform equally well to allow the mouthpiece to provide both filtration and heat and moisture exchange if the filter is provided on an external patient facing side of the heat and moisture exchange apparatus. See MPEP 2144.04(VI)(C).
Response to Arguments
Applicant's arguments filed 7/5/2026 have been fully considered but they are not persuasive.
Applicant argues on page 5, fourth full paragraph-page 6, third full paragraph of applicant’s remarks, that the prior art does not disclose a filter for a therapy device that provides an oscillating resistance to flow because Pelerossi does not disclose the device having a filter, and Cegla’s device is not configured to provide an oscillating resistance to flow because Cegla’s device lacks a restriction to set up vibrations in the lungs to aid liberation of secretions. However, Cegla teaches the benefit of providing a filter in the mouthpiece to clean the air which flows through the device, and to capture and hold back suspended matter or microparticles (para [0026]), and therefore, providing a filter to Pelerossi’s mouthpiece would also provide a benefit of clean the air which flows through the device, and to capture and hold back suspended matter or microparticles. Although not relied on in the current rejection, Tuitt et al (2003/0192545) teaches a device to provide high frequency variable pressure to a patient to facilitate clearing secretions (abstract), and including a mouthpiece (42) which includes a bacterial filter (para [0025]), and therefore, the feature of providing a filter to a mouthpiece of a high frequency pressure oscillation device is known in the art. Therefore, the rejection is maintained.
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.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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