DETAILED ACTION
This office action is in response to the claims filed 6/27/2023. Claims 1-20 are presenting 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: “the fluid pulse generator” in claim 4.
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 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.
Claim(s) 4-5 and 12 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 4 recites the limitation "the fluid pulse generator" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the plurality of fluid pods" in line 1. There is insufficient antecedent basis for this limitation in the claim, as claim 1, from which claim 12 depends from, previously recites at least one fluid pod.
Claim 5 is rejected for being either directly or indirectly depending from a rejected claim base.
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 1, 6-10, 12-14, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar (WO93/17650A1) in view of Gelfand et al (5,769,800).
Regarding claim 1, Molnar discloses a high-frequency chest wall oscillation (HFCWO) system comprising: a garment (10) (vest) configured to be worn around a chest of a user (para [0018]); and at least one fluid pod (20) (each percussion body (15) includes a cylinder housing (19) (para [0019]), and a pneumatic drive device (20) that can be a pump bellows (para [0020]) housed by the garment (10) and configured to receive a fluid (para [0020]), the at least one fluid pod (19) including: a housing (outer portion of bellows) and a cavity formed by the housing (inner portion of bellows configured to receive air) (para [0020]).
Molnar does not disclose a dome located in the cavity to reduce a volume of an air-receiving portion of the cavity.
However, Gelfand in figs 10a-c teaches a device configured to provide pressure to a user (vest for cardiopulmonary resuscitation) (abstract) including a fluid pod (main bladder) and including an element such as a secondary bladder (88), a foam or other substance (90), or a honeycomb design (92) is placed in the main bladder in order to reduce dead space in the main bladder (col 5, ln 18-44).
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 at least one fluid pod of Molnar by providing an element such as a secondary bladder, a foam or other substance, or a honeycomb design in the cavity of the at least one fluid pod to reduce a volume of an air-receiving portion of the cavity as taught by Gelfand in order to reduce the amount of dead space in each of the fluid pods to reduce the amount of compressed air needed to actuate the fluid pods, and therefore requiring less energy to operate the device (Gelfand, col 5, ln 40-44).
The now-modified Molnar’s device does not disclose that the element located in the cavity to reduce a volume of an air-receiving portion of the cavity is a dome.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of modified Molnar so that the element located in the cavity to reduce a volume of an air-receiving portion of the cavity is a dome, as it would be an obvious change in shape, as a dome shaped-element within the cavity would perform equally well to reduce a volume of an air-receiving portion of the cavity to reduce the amount of dead space in each of the fluid pods to reduce the amount of compressed air needed to actuate the fluid pods, and therefore requiring less energy to operate the device. See MPEP 2144.04(IV)(B).
Regarding claim 6, Molnar discloses at least one fluid pod pocket formed between an outer layer (29) (outer film) of the garment (10) and an inner layer (27) (inner film) of the garment (10), wherein the at least one fluid pod (20) is housed in the at least on fluid pod pocket (para [0022]).
Regarding claim 7, Molnar discloses the at least one fluid pod pocket is sized so that the at least one fluid pod (20) is moveable within the at least one fluid pod pocket to adjust a position of the at least one fluid pod (20) relative to the user's anatomy (cylinder body (19) is interchangeably anchored in the vest parts (10.1-10.3) (para [0021]) and end faces of cylinder body (19) can be anchored by means of Velcro fasteners (para [0022])).
Regarding claim 8, Molnar disclose the garment (10) includes: a rear portion (10.3) (back piece); a left front portion (10.2) (left front piece); and a right front portion (10.1) (right front piece); wherein the at least one fluid pod includes at least one of a rear fluid pod (15) located in the rear portion (10.3) (as shown in fig 1, rear portion (10.3) includes a plurality of percussion bodies (15) (para [0018]), and each percussion body (15) includes a fluid pod (fig 2, para [0019])), a left front fluid pod (15) located in the left front portion (10.2) (as shown in fig 1, left front portion (10.2) includes a plurality of percussion bodies (15) (para [0018]), and each percussion body (15) includes a fluid pod (fig 2, para [0019])), and a right front fluid pod (15) located in the right front portion (as shown in fig 1, right front portion (10.1) includes a plurality of percussion bodies (15) (para [0018]), and each percussion body (15) includes a fluid pod (fig 2, para [0019])).
Regarding claim 9, Molnar disclose the garment (10) includes: a rear portion (10.3) (back piece); a left front portion (10.2) (left front piece); and a right front portion (10.1) (right front piece); wherein the at least one fluid pod includes at least two of a rear fluid pod (15) located in the rear portion (10.3) (as shown in fig 1, rear portion (10.3) includes a plurality of percussion bodies (15) (para [0018]), and each percussion body (15) includes a fluid pod (fig 2, para [0019])), a left front fluid pod (15) located in the left front portion (10.2) (as shown in fig 1, left front portion (10.2) includes a plurality of percussion bodies (15) (para [0018]), and each percussion body (15) includes a fluid pod (fig 2, para [0019])), and a right front fluid pod (15) located in the right front portion (as shown in fig 1, right front portion (10.1) includes a plurality of percussion bodies (15) (para [0018]), and each percussion body (15) includes a fluid pod (fig 2, para [0019])).
Regarding claim 10, Molnar disclose the garment (10) includes: a rear portion (10.3) (back piece); a left front portion (10.2) (left front piece); and a right front portion (10.1) (right front piece); wherein the at least one fluid pod includes a rear fluid pod (15) located in the rear portion (10.3) (as shown in fig 1, rear portion (10.3) includes a plurality of percussion bodies (15) (para [0018]), and each percussion body (15) includes a fluid pod (fig 2, para [0019])), a left front fluid pod (15) located in the left front portion (10.2) (as shown in fig 1, left front portion (10.2) includes a plurality of percussion bodies (15) (para [0018]), and each percussion body (15) includes a fluid pod (fig 2, para [0019])), and a right front fluid pod (15) located in the right front portion (as shown in fig 1, right front portion (10.1) includes a plurality of percussion bodies (15) (para [0018]), and each percussion body (15) includes a fluid pod (fig 2, para [0019])).
Regarding claim 12, Molnar discloses one of the plurality of fluid pods (20) is fluidly downstream of another one of the plurality of fluid pods (20) (cylinder housing (19) includes a connection (23) that can connect to a connection (22) of another knocking body (15)) (para [0019]).
Regarding claim 13, Molnar discloses the garment (10) includes an outer layer (29) (outer film) and an inner layer (27) (inner film), wherein the at least one fluid pod (20) is located between the outer layer (29) and the inner layer (27), wherein the inner layer (27) is configured to position against the user (para [0022]).
Regarding claim 14, Molnar discloses a fastener of the at least one fluid pod (19) is located adjacent the outer layer (29) (end faces of cylinder housing (19) is anchored to outer layer (29) by means of a Velcro fastener) (para [0022]).
Regarding claim 20, Molnar discloses the fluid is air (para [0019]).
Claim 2-5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar and Gelfand et al as applied to claim 1 above, and further in view of Chang Guo et al (2013/0289456).
Regarding claim 2, modified Molnar discloses a compressed air source (Molnar, para [0019]).
Modified Molnar does not disclose the compressed air source comprises a blower configured to pressurize the fluid to generate pressurized fluid.
However, Chang Guo teaches a device configured to provide a compressive force to a chest of a user including an air pod (14) (therapy chamber is a bladder) (para [0021]) and a compressed air source (20) (fluid source), wherein the fluid supply (20) is a blower (para [0021]).
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 Molnar so that the compressed air source comprises a blower as taught by Chang Guo, as the use of a blower to provide a compressed air to a therapeutic compression device is known in the art, and it appears that the device of modified Molnar would perform equally well to provide a compressive force to a chest of a patient using a blower.
Regarding claim 3, modified Molnar discloses a blower.
Modified Molnar does not disclose the blower is housed in the garment.
However, Chang Guo teaches a device configured to provide a compressive force to a chest of a user including an air pod (14) (therapy chamber is a bladder) (para [0021]) and a blower (20) (fluid source can be a blower) (para [0021]), and including control circuitry (24) (PCB), a battery (26) (para [0023]), and an air pulse generator (32) (para [0022]), wherein the blower (20), control circuitry (26), and air pulse generator (32) is housed in a garment (see fig 3, para [0023]).
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 Molnar so that the blower is housed in the garment as taught by Chang Guo in order to allow a patient to use the device without requiring a user to be connected to an external device or a source of power while using the device.
Regarding claim 4, modified Molnar discloses a blower.
Modified Molnar does not disclose control circuitry configured to control the blower; and a battery configured to power the control circuitry, the blower, and a fluid pulse generator
However, Chang Guo teaches a device configured to provide a compressive force to a chest of a user including an air pod (14) (therapy chamber is a bladder) (para [0021]) and a blower (20) (fluid source can be a blower) (para [0021]), and including control circuitry (24) (PCB) to control the blower, a battery (26) (para [0023]), and an air pulse generator (32) (para [0022]), wherein the blower (20), control circuitry (26), and air pulse generator (32) is housed in a garment (see fig 3, para [0023]).
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 Molnar by providing control circuitry configured to control the blower; and a battery configured to power the control circuitry, the blower, and a fluid pulse generator as taught by Chang Guo in order to provide control signals to control the blower and an air pulse generator in order to provide high frequency chest wall oscillation therapy to a patient (Chang Guo, para [0022]).
Regarding claim 5, the modified Molnar’s reference discloses each of the blower (20 of Chang Guo), the control circuitry (26 of Chang Guo), and the battery (26 of Chang Guo) are housed in the garment (14 of Chang Guo) (Chang Guo, fig 3, para [0023]).
Regarding claim 11, modified Molnar discloses the at least one fluid pod includes a plurality of fluid pods in fluid communication with a compressed air source.
Modified Molnar does not disclose the compressed air source comprises a blower configured to pressurize the fluid to generate pressurized fluid.
However, Chang Guo teaches a device configured to provide a compressive force to a chest of a user including an air pod (14) (therapy chamber is a bladder) (para [0021]) and a compressed air source (20) (fluid source), wherein the fluid supply (20) is a blower (para [0021]).
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 Molnar so that the compressed air source comprises a blower as taught by Chang Guo, as the use of a blower to provide a compressed air to a therapeutic compression device is known in the art, and it appears that the device of modified Molnar would perform equally well to provide a compressive force to a chest of a patient using a blower.
Claim 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar and Gelfand et al as applied to claim 1 above, and further in view of Mitchell et al (2016/0113839).
Regarding claim 15, modified Molnar discloses a fluid membrane.
Modified Molnar does not disclose a moveable membrane of the at least one fluid pod is located adjacent the inner layer.
However, Mitchell in fig 4 teaches a device for performing high frequency chest wall oscillation including an air pod (1) wherein a moveable membrane (300) (head including impact face (311) (para [250]) is formed as a movable membrane that is slightly deformable to adapt to contorts of the patient's thorax (para [0368])) which is configured to be disposed towards a user’s body (para [0271]).
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 Molnar by substituting the bell body knocking element with a movable membrane configured to be disposed towards a user’s body as taught by Michell, it would be a simple substitution of one element known in the art to apply HFCWO with another, and providing a movable membrane that is slightly deformable would allow the air pod to adapt to contorts of the patient's thorax (Mitchell, para [0368]). The now-modified Molnar’s device is considered that the moveable membrane is located adjacent the inner layer, as the moveable membrane is configured to face the patient (Mitchell, para [0271]) and the inner layer is configured to face the patient (Molnar, para [0022]) and therefore would be adjacent to one another.
Regarding claim 16, modified Molnar discloses a housing.
Modified Molnar does not disclose a moveable membrane is coupled to the housing and configured to pulsate against the user.
However, Mitchell in fig 4 teaches a device for performing high frequency chest wall oscillation including an air pod (1) wherein a moveable membrane (300) (head including impact face (311) (para [250]) is formed as a movable membrane that is slightly deformable to adapt to contorts of the patient's thorax (para [0368])) which is configured to be disposed towards a user’s body to pulsate against a suer (para [0271]).
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 Molnar by substituting the bell body knocking element with a movable membrane configured to be disposed towards a user’s body as taught by Michell, it would be a simple substitution of one element known in the art to apply HFCWO with another, and providing a movable membrane that is slightly deformable would allow the air pod to adapt to contorts of the patient's thorax (Mitchell, para [0368]).
Regarding claim 17, modified Molnar discloses a housing.
Modified Molnar does not disclose a moveable membrane is coupled to the housing and formed from a flexible material.
However, Mitchell in fig 4 teaches a device for performing high frequency chest wall oscillation including an air pod (1) wherein a moveable membrane (300) (head including impact face (311) (para [250]) is formed as a movable membrane that is slightly deformable to adapt to contorts of the patient's thorax (para [0368])) and formed from a flexible material (elastic material such as silicon) (para [00293])
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 Molnar by substituting the bell body knocking element with a movable membrane configured to be disposed towards a user’s body and made of a flexible material as taught by Michell, it would be a simple substitution of one element known in the art to apply HFCWO with another, and providing a movable membrane that is slightly deformable would allow the air pod to adapt to contorts of the patient's thorax (Mitchell, para [0368]).
Regarding claim 18, modified Molnar discloses a dome of at least one fluid pod.
Modified Molnar does not discloses the dome of the at least one fluid pod is positioned against a bottom panel of the housing.
However, Mitchell teaches a device for performing high frequency chest wall oscillation including an air pod, and in fig 7 shows a bottom panel (314) (outer face of the frame) in contact with an inner face (231) of the frame, with a protruding portion of the frame extending into the cavity of the at least one fluid pod (para [0306]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of modified Molnar so that the dome of the at least one fluid pod is positioned against a bottom panel of the housing, as the location of the dome within the at least one fluid pod is considered to be an obvious rearrangement of parts, as a protruding portion disposed at a bottom of a fluid pod positioned against a bottom panel of a housing is known in the art, and a dome positioned against a bottom panel of the housing would perform equally well to reduce the amount of dead space in each of the fluid pods to reduce the amount of compressed air needed to actuate the fluid pods, and therefore requiring less energy to operate the device. See MPEP 2144.04(VI)(C).
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar and Gelfand et al as applied to claim 1 above, and further in view of Thomas et al (6,551,450).
Regarding claim 19, modified Molnar discloses a fluid pod shown to be cylindrical with a diameter and a thickness.
Modified Molnar does not disclose a diameter of the at least one fluid pod is greater than a thickness of the at least one fluid pod.
However, Thomas in fig 7 teaches a device configured to apply pressure to a user (as shown in fig 17-18, device can be a cuff apparatus (300) for wrapping around a body part) (col 21, ln 24-37), wherein the device includes at least one fluid pod (28) (air spring), wherein the at least one fluid pod has a diameter OD1 with a wider diameter (3.5-3.7 inches) (col 13, ln 33-38) than a thickness H2 (approximately 1.66 inches) of the at least one fluid pod (col 13, ln 25-32).
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 Molnar so that a diameter of the at least one fluid pod is greater than a thickness of the at least one fluid pod as taught by Thomas, as the feature of a fluid pod with diameter that is greater than a thickness of the at least one fluid pod is known in the art, and it appears that the device of modified Molnar would perform equally well to provide pressure to a user if a diameter of the at least one fluid pod is greater than a thickness of the at least one fluid pod.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Huster et al (2009/0192421), Kimani Mwangi et al (8,578,939), Kitou (2008/0080793), and Stryker et al (2014/0276271) discloses devices including inflatable elements to provide therapeutic pressure to a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached on 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785