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 responsive to an amendment filed on 2/25/2026. As directed by the amendment, claims 51, 53, 57, 59, 61-62 were amended, claims 1-50, 52, 63 and 70 were cancelled and new claims 71-75 were added. Thus, claims 51, 53-62, 64-69 and 71-75 are presently pending in this application.
Claims 64-69 are withdrawn as stated in the Non-Final rejection mailed on 10/02/2025.
Claim 75 is withdrawn because claim 75 is being directed to an invention that is independent or distinct from the invention originally claimed, see the restriction below.
Election/Restrictions
Newly submitted claim 75 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 51, 53-62, and 71-74, drawn to a method for providing treatment adapted to clear lung airways.
Group II, claim 75, drawn to a method for providing treatment adapted to clear lung airways.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a method for providing treatment adapted to clear lung airways comprising activating at least one pressure applicator to apply pressure on a torso of a patient, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Chu (2,869,537) or alternatively, Warwick (2002/0111571).
Chu discloses a method for providing treatment adapted to clear lung airways (see col 2, lines 7-65, Chu discloses that patients with chronic pulmonary emphysema experience the greater difficulty in the expiratory state by not expelling enough volume of air during the respiratory cycle, this is due to the prolonged over-distension of the lungs plus airway obstructions, and based on that reasoning, the present device is a vest that would be used to treat such condition, which would be adapted to clear lung airways due to reducing over-distension of the lungs and volume of residual air contained therein to improve inspiration and expiration), the method comprising; placing at least one pressure applicator on a patient's torso (vest 10, figs. 1-3, col 3, lines 14 to col 4, line 41); and performing a treatment protocol, said treatment protocol comprising activating and deactivating said at least one pressure applicator to apply and release pressure on said torso (see col 2, line 29-col 4 line 65, Chu discloses in col 2, lines 29-50 that the compression of the torso region would change the volume of the lung, and the displacement volume in each respiratory cycle is increased, furthermore, Chu discloses the inflation of air bags 22 and the deflation of the vest).
Warwick discloses a method for providing treatment adapted to clear lung airways (see paragraph 0028, Warwick discloses the compression pulses produce transient cephalad airflow spikes in the airway, the high airflow spikes produce the more desirable shear forces necessary for effective mucous clearance, see paragraphs 0037-0038 and 0047), the method comprising; placing at least one pressure applicator on a patient’s torso (see vest 18 in fig. 1, paragraphs 0021, 0026, 0028, 0032, 0037 and 0039-0040); and performing a treatment protocol, said treatment protocol comprising activating and deactivating said at least one pressure applicator to apply and release pressure on said torso (see paragraphs 0020 and 0028, Warwick discloses compression pulses, therefore, there would an activation and deactivation of the pressure to apply and release pressure on the torso, alternatively, in paragraph 0044, Warwick discloses the stopping of the pulsing during inspiration to make it easier to inhale maximally, alternatively, Warwick discloses in paragraph 0043 that the patient uses the hand control to stop pulsing as frequency as necessary to cough, usually every several minutes); wherein said treatment protocol comprises limiting the patient’s breathing to different lung volumes at different breathing thereby providing treatment to clear lung airways (see paragraphs 0020, 0029, 0043-0044, and 0047, Warwick discloses that the compression pulses makes it difficult to inhale maximally, therefore, the treatment protocol is limiting the patient’s breathing to different lung volumes at different breathing cycles, since during inhalation, maximal inhalation are difficult to attain while exhalation is easily attainable due to the compression pulses acting on the chest and lungs of the patient, alternatively, at every breathing cycle, the breathing lung volume would be a different breathing lung volume since it occurs at a different point in time, therefore, by limiting breathing to a lung volume during inhalation would be limiting the patient’s breathing to different lung volumes at different breathing cycles, it is noted that the claim does not define what makes the different lung volumes different, alternatively, the compression pulses are assisting in the exhalation, therefore, is limiting the patient’s breathing to different volumes during exhalation in that the compression pulsing is allowing a limit in breathing lung volume to be established when activated versus when the device is off entirely).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 75 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claims 51 and 59 are objected to because of the following informalities:
In claim 51, line 5, the term “i.” is suggested to be changed to --(i)-- since only one period can be in a claim.
In claim 51, line 8, the term “ii.” is suggested to be changed to --(ii)-- since only one period can be in a claim.
In claim 51, line 10, the term “i.” is suggested to be changed to --(i)-- since only one period can be in a claim.
In claim 51, line 13, the term “ii.” is suggested to be changed to --(ii)-- since only one period can be in a claim.
In claim 59, line 2, the term “first and/or second pressure applicator” is suggested to be changed to --said at least one first pressure applicator and/or said at least one second pressure applicator-- in order to clarify the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 51, 53-62, and 71-74 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.
In claim 51, the limitation “after one or more breathing cycles” (line 12) is unclear if the “one or more breathing cycles” (line 12) is referring to the “one or more breathing cycles” being claimed in line 7 or not.
Regarding claim 53, the limitation “at least one pressure applicator” (line 3) is unclear if the at least one pressure applicator is the same as or different from “at least one first pressure applicator” or “at least one second pressure applicator” being claimed in claim 51.
Regarding claim 53, the limitation “at least one other pressure applicator” (line 6) is unclear if the at least one other pressure applicator is the same as or different from “at least one first pressure applicator” or “at least one second pressure applicator” being claimed in claim 51. Furthermore, it is unclear as to what the term “other” is referring to, “other” relative to what structure or reference point.
Any remaining claims are rejected for their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 51, 53, 62, and 71-73 are rejected under 35 U.S.C. 102(a)(2) as anticipated by Stryker (2014/0276271) or, in the alternative, under 35 U.S.C. 103 as obvious over Stryker (2014/0276271) in view of Helgeson (2013/0331747) and University Hospital Llandough (“Autogenic Drainage”).
Regarding claim 51, Stryker discloses a method for providing treatment adapted to clear lung airways (see abstract, paragraphs 0003-0017, 0039 and 0054) using device (10, figs. 1-5), the method comprising: placing a plurality of pressure applicators (12a, 12b, 12c, 12d, 12e, 24g, and 24f, figs. 1-2, paragraphs 0035-0043) on a patient’s torso (see figs. 1-5); and performing a treatment protocol, said treatment protocol comprising: (a) i. activating at least one first pressure applicator (12e, figs. 1-5) from said plurality of pressure applicators (see fig. 7 and paragraphs 0034-0037, Stryker discloses that the chambers provided by bladders or bladder segments, which may be inflated and deflated to apply the sequential compression or constriction on the patient’s chest and further discloses in paragraph 0041 that the pulsing of the pressure in the chambers serially, device 10 is able to generate sequential constriction or compression that can be applied to the patient’s chest that moves from the bottom of the patient’s chest up to or near the top of the patient’s chest, furthermore, see paragraphs 0055-0061), at a first activation time, to applying pressure on said torso (see fig. 7, paragraphs 0034-0037, 0041 and 0055-0061, the pressure being applied to 12e would have a first activation time, that takes place after one or more breathing cycles), and, after one or more breathing cycles, ii. Deactivating said at least one first pressure applicator at a first deactivation time, to release pressure from said torso (see fig. 7, paragraphs 0034-0037, 0041 and 0055-0061, since there is a pulse, the deactivation of the pulse would take place after one or more breathing cycles for a pulse that is activated, or alternatively, the deactivation can takes place at a later time for a separate pulse, the one or more breathing cycles are any one or more breathing cycles that took place before the deactivation); and (b) i. activating at least one second pressure applicator (12d, figs. 1-4) from said plurality of pressure applicators, at a second activating time, to apply pressure on said torso (see paragraphs 0034-0037, 0041, and 0055-0061, Stryker discloses that pressure can be applied sequentially, therefore, activating 12d would takes place at a second activating time), and, after one or more breathing cycles, ii. Deactivating said at least one second pressure applicator at a second deactivation time, to release pressure from said torso (see fig. 7, paragraphs 0034-0037, 0041 and 0055-0061, since there is a pulse, the deactivation of the pulse would take place after one or more breathing cycles for a pulse that is activated, or alternatively, the deactivation can takes place at a later time for a separate pulse, it is noted that the claim does not claim that between the activation and deactivation, there are no pressure pulses); wherein said first activation time precedes said second activation time (see fig. 7, paragraphs 0034-0037, 0041 and 0055-0061, for sequential activation of the chambers from the bottom up, right at the beginning, the first activation time of 12e would precedes the second activation time of 12d) such that application of pressure by said at least one first pressure applicator and said at least one second pressure applicator overlaps for only a part of a duration of the treatment protocol (see fig. 7, paragraphs 0034-0037, 0041 and 0055-0061, as disclosed the first and second pressure applicators are pressurized to a base pressure and pulses sequentially, therefore, the application of pressure by said at least one first pressure applicator and said at least one second pressure applicator overlaps for only a part of a duration of the treatment protocol); wherein said treatment protocol comprises limiting the patient’s breathing to different lung volumes at different breathing cycles, thereby providing treatment to clear lung airways (fig. 7, paragraphs 0011, 0034-0037, 0041 and 0055-0061, the pressure being applied by the chambers are configured to help clear the mucus, by sequentially compressing the torso from the bottom up, the sequential compression of the torso would include limiting breathing to different volumes at different breathing cycles in the same manner as the applicant’s pressure applicators).
However, if there is any doubt that the treatment protocol comprises limiting the patient’s breathing to different lung volumes at different breathing cycles, thereby providing treatment to clear lung airways.
Helgeson teaches that chest physiotherapy being used to enhance respiratory mucus transport can include mechanical manipulation of the chest and autogenic drainage (see paragraph 0004). University Hospital Llandough teaches that autogenic drainage includes limiting breathing to different lung volumes at different breathing cycles (see pages 1-2, University Hospital Llandough discloses that Autogenic Drainage includes breathing at low lung volume, middle lung volume and high lung volume).
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 treatment protocol of Stryker to include autogenic drainage as taught by Helgeson and University Hospital Llandough for the purpose of enhancing airway clearance using a well-known breathing technique.
Regarding claim 53, Stryker or the modified Stryker discloses that said treatment protocol comprises: activating at least one pressure applicator from the plurality of pressure applicators, the at least one pressure applicator located next to a top of the patient’s torso, applying pressure at least a portion of the top of the patient’s torso; and activating at least one other pressure applicator from the plurality of pressure applicators, the at least one other pressure applicator located next to a bottom of said patient’s torso, applying pressure to at least a portion of the bottom of the patient’s torso (see figs. 1-4 and paragraphs 0011, 0034-0037, 0041 and 0055-0061, the at least one pressure applicator next to a top of the patient’s torso can be 12a or 24f or 24g, while the at least one other pressure applicator next to a bottom can be 12e or 12d of Stryker, alternatively, in a supine position, 12e would be located next to the top and bottom of the torso and 12d would be located next to the top and bottom of the torso, bottom being the back of the patient and top being the front of the patient).
Regarding claim 62, Stryker or the modified Stryker discloses all the structures and method as claimed and included the rapid deactivation of the first and/or second pressure applicators of said plurality of the pressure applicators (see figs. 1-4 and paragraphs 0011, 0034-0037, 0041 and 0055-0061, the pressure pulses are discloses as pulses, therefore, the deactivation would be rapid, alternatively, any deactivation would be considered to be rapid since the term rapid is relative), therefore, would be able to increase transpulmonary pressure gradient in said patient’s lungs.
Regarding claim 71, Stryker or the modified Stryker discloses that said treatment protocol comprises, during said overlap of application of pressure by said at least one first pressure applicator and said at least one second pressure applicator, limiting said patient’s breathing to a lung-volume range lower than a lung-volume range in which said patient’s breathes with during the time period between said first activation and said second activation time (fig. 7, paragraphs 0011, 0034-0037, 0041 and 0055-0061, the pressure being applied by the chambers are configured to help clear the mucus, by sequentially compressing the torso from the bottom up, the sequential compression of the torso would include limiting breathing to different volumes at different breathing cycles in the same manner as the applicant’s pressure applicators, the pulses takes place during the overlap of pressure, the time period between said first activation and said second activation can be defined as a time period between multiple pulses which has periods where there are base pressure without pulsing, while the overlap is interpreted when the base pressure overlaps and when the chambers are being sequentially pulsed at a higher pressure than base pressure, therefore, would limit said patient’s breathing to a lung volume range lower than a lung-volume range in which said patient’s breathes with during the time period between said first activation and said second activation time).
Regarding claim 72, Stryker or the modified Stryker discloses that the at least one first pressure applicator is located next to a top of the patient’s torso and configured for applying pressure to at least a portion of the top of the patient’s torso; and wherein the at least one second pressure applicator is located next to a bottom of said patient’s torso and configured for applying pressure to at least a portion of the bottom of the patient’s torso (the first applicator 12e goes around the user, therefore, when the patient is in a supine position, would be located next to a top of the patient’s torso (chest), while the second pressure applicator (12d) also extends around the torso and would be located next to a bottom of said patient’s torso when the patient is in a supine position (back), alternatively, in an upright position, since there will be multiple pulses that takes place sequentially, the first applicator (redefined as 24h or 24g or 12a) would be located next to the top of the torso while the second applicator (redefined as 12e) would be located at the bottom, multiple pulses would have one pulse that has an activation time that precedes the other, see fig. 7, paragraphs 0011, 0034-0037, 0041 and 0055-0061 of Stryker).
Regarding claim 73, Stryker or the modified Stryker discloses that said second deactivation time precedes said first deactivation time such that pressure is applied by said at least one first pressure applicator after release of pressure by said at least one second pressure applicator (fig. 7, paragraphs 0011, 0034-0037, 0041 and 0055-0061 of Stryker, the treatment protocol loops until lung is clear, therefore, there would be multiple pulses depending on a particular patient’s condition, therefore, there would be a second deactivation time that precedes a first deactivation time such that pressure is applied by said at least one first pressure applicator after release of pressure by said at least one second pressure applicator).
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Stryker (2014/0276271) or alternatively in view of Helgeson (2013/0331747) and University Hospital Llandough (“Autogenic Drainage”) as applied to claim 51 above, and further in view of Ayu (2021/0137779).
Regarding claim 54, Stryker or the modified Stryker fails to disclose sensing a signal associated with said patient; analyzing said signal; and performing the treatment protocol based on the analyzing.
However, Ayu teaches sensing a signal associated with said patient; analyzing said signal; and performing the treatment protocol based on the analyzing (see paragraphs 0084-0091 of Ayu, Ayu discloses sensor 24 for sensing breathing pattern, and further discloses that the control system 46 utilize computational analysis of the sensor data to provide a motion construction of the patient’s breathing and based on the motion construction, the therapy control system 46 can configure the therapy regime).
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 method of Stryker to have the step of sensing a signal associated with said patient; analyzing said signal; and performing the treatment protocol based on the analyzing as taught by Ayu for the purpose of providing an automatic system that would be able to sense when the patient still needs the treatment protocol (see paragraphs 0084-0091 of Ayu).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Stryker (2014/0276271) in view of Helgeson (2013/0331747) and University Hospital Llandough (“Autogenic Drainage”).
Regarding claim 55, the modified Stryker discloses that the treatment protocol enables autogenic drainage (see the modification with Helgeson and University Hospital Llandough in the rejection to claim 51, see paragraph 0004 of Helgeson and see pages 1-2, University Hospital Llandough).
Claims 56-57 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Stryker (2014/0276271) in view of Helgeson (2013/0331747) and University Hospital Llandough (“Autogenic Drainage”) as applied to claim 51 above, and alternatively in view of Milton (2014/0065602).
Regarding claim 56, the modified Stryker discloses providing guidance to said patient to instruct said patient as to a desired breathing pattern (see the modification with University Hospital Llandough, the modified Stryker’s method would include the step of providing guidance to the patient to instruct the patient as to a desired breathing pattern since the disclosure of University Hospital Llandough on pages 1-2 would need to instruct the patient how to breathe based on androgenic drainage technique, since the disclosure made by University Hospital Llandough itself is a guide, and since the patient would have to perform the breathing pattern in order to obtain the effects of Autogenic Drainage, the patient would be guided/instructed by the disclosure of University Hospital Llandough).
If there is any doubt that the modified Stryker discloses providing guidance to said patient to instruct said patient as to a desired breathing pattern.
Milton teaches a display screen to provide guidance to instruct the patient to breathe a breathing pattern (see paragraph 0067).
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 treatment protocol and method of the modified Stryker to provide guidance on the breathing pattern of the modified Stryker as taught by Milton for the purpose of providing clear instruction to the patient on how to breathe when needed, thereby providing comfort to the patient by effectively treating airway occlusion.
Regarding claim 57, the modified Stryker discloses that the guidance is synchronized to said activating and deactivating of said at least one first pressure applicator or at least one second pressure applicator (see the modification with Helgeson and University Hospital Llandough in the rejection to claim 51, see paragraph 0004 of Helgeson, Helgeson discloses that androgenic drainage be combined with physical chest manipulation and see pages 1-2, University Hospital Llandough which discloses breathing patterns for limiting breathing to different lung volumes to help with airway clearance, therefore, once modified, the guidance would be synchronized with the pressure applicator, it is noted that the claim does not claim how they are synchronized, therefore, any usage of the androgenic drainage breathing techniques would be in synchronization with the activation and deactivation of the pressure applicator, alternatively, see the modification with Milton, the instruction on the breathing pattern would be modified to be on a screen, which would be synchronized with the activation and deactivation with the pressure applicator since the modification included the screen into the device of Stryker).
Regarding claim 74, the modified Stryker discloses that synchronizing said providing guidance to the patient as to a breathing pattern, with activation of one or more of said at least one first pressure applicator and said at least one second pressure applicator (see the modification with Helgeson and University Hospital Llandough in the rejection to claim 51, see paragraph 0004 of Helgeson, Helgeson discloses that androgenic drainage be combined with physical chest manipulation and see pages 1-2, University Hospital Llandough which discloses breathing patterns for limiting breathing to different lung volumes to help with airway clearance, therefore, once modified, the guidance would be synchronized with the pressure applicator, it is noted that the claim does not claim how they are synchronized, therefore, any usage of the androgenic drainage breathing techniques would be in synchronization with the activation and deactivation of the pressure applicators, alternatively, see the modification with Milton, the instruction on the breathing pattern would be modified to be on a screen, which would be synchronized with the activation and deactivation with the pressure applicator since the modification included the screen into the device of Stryker).
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over Stryker (2014/0276271) in view of Helgeson (2013/0331747) and University Hospital Llandough (“Autogenic Drainage”) as applied to claim 54 above, and further in view of Ayu (2021/0137779) and Ye (2018/0177483).
Regarding claim 58, the modified Stryker discloses providing guidance to said patient to instruct said patient as to a desired breathing pattern and that the guidance is based on the sensing.
However, Ayu teaches providing guidance to said patient to instruct said patient as to a desired breathing pattern (see paragraphs 0141-0143 of Ayu, Ayu discloses that the pausing of the device has a cough pause, and can automatic resume treatment, wherein the cough is part of a breathing pattern, and by ending the cough pause, the method/device is guiding the patient to instruct the patient to a desired breathing pattern, which is continuing the breathing pattern without the cough being part of the breathing pattern).
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 method and device of Stryker to have the method of providing guidance as taught by Ayu for the purpose of providing safety and comfort to the patient by pausing the treatment protocol when the user needs to cough (see paragraphs 0141-0143 of Ayu).
The modified Stryker discloses providing guidance to said patient to instruct said patient as to a desired breathing pattern and that the guidance is based on the sensing.
However, Ye teaches that the cough sensor for automatically deactivating the pressure applicator once coughing over a threshold has been detected (see paragraphs 0033 and 0050-0051, Ye discloses that breath sounds may be analyzed to monitor coughing and to stop the lung therapy with the HFCWO vest when coughing is detected to be above the threshold).
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 method and device of the modified Stryker to have the cough sensor as taught by Ye for the purpose of providing safety and comfort to the patient by automatically detecting when the patient is coughing and stopping the treatment of the pressure applicator once coughing is detected to be over a threshold to allow the patient to freely cough (see paragraphs 0033 and 0050-0051 of Ye).
After the modification, the guidance that instruct said patient as to a desired breathing pattern would be based on the sensing of the cough sensor of Ye, since after the modification with Ye, the device of Stryker enters a cough pause automatically based on the cough sensor and resume after a set duration as set out by Ayu, therefore, the return of the treatment is a form of instruction to a normal breathing pattern without the cough, which is based on the sensing of the cough sensor.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Stryker (2014/0276271) in view of Helgeson (2013/0331747) and University Hospital Llandough (“Autogenic Drainage”) as applied to claim 51 above, and further in view of Ayu (2021/0137779).
Regarding claim 59, Stryker or the modified Stryker fails to disclose that the method is configured to induce coughing by deactivation of said at least one first or second pressure applicator of said plurality of pressure applicators.
Ayu teaches to induce coughing by deactivation of said at last one pressure applicator (see paragraphs 0048, 0141-0143 and 0170 of Ayu, Ayu discloses that the pausing of the device has a cough pause for pausing therapy and can automatically end the cough pause and resume treatment).
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 method of Stryker or the modified Stryker to be configured to induce coughing by deactivation of said at least one first or second pressure applicator of said plurality of pressure applicators of Stryker or the modified Stryker as taught by Ayu for the purpose of providing safety and comfort to the patient by pausing the treatment protocol when the user needs to cough (see paragraphs 0141-0143 of Ayu).
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Stryker (2014/0276271) in view of Helgeson (2013/0331747) and University Hospital Llandough (“Autogenic Drainage”).
Regarding claim 60, the modified Stryker discloses that the guidance comprises breathing instructions to said patient to a desired breathing pattern having shallow inspiration and long deep inspiration (see page 1 of University Hospital Llandough, which discloses breathing at low lung volume in phase 1 (shallow inspiration), alternatively, see phase 3, inhale until your lungs feel full (long deep inspiration)).
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Stryker (2014/0276271) in view of Helgeson (2013/0331747) and University Hospital Llandough (“Autogenic Drainage”) as applied to claim 54 above and further in view of Ayu (2021/0137779) and Ye (2018/0177483).
Regarding claim 61, Stryker or the modified Stryker fails to disclose to induce coughing by deactivation of said at last one pressure applicator said first and/or second pressure applicator of the plurality of pressure applicators is deactivated.
However, Ayu teaches to induce coughing by deactivation of said at last one pressure applicator said first and/or second pressure applicator of the plurality of pressure applicators is deactivated (see paragraphs 0048, 0141-0143 and 0170 of Ayu, Ayu discloses that the pausing of the device has a cough pause for pausing therapy and can automatically end the cough pause and resume treatment).
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 method of Stryker or the modified Stryker to be configured to induce coughing by deactivation of said at least one first or second pressure applicator of said plurality of pressure applicators of Stryker or the modified Stryker as taught by Ayu for the purpose of providing safety and comfort to the patient by pausing the treatment protocol when the user needs to cough (see paragraphs 0141-0143 of Ayu).
The modified Stryker fails to disclose that upon detection of a cough or intention to cough, at least one of said first and/or second pressure applicators is deactivated.
However, Ye teaches that the cough sensor for automatically deactivating the pressure applicator once coughing over a threshold has been detected (see paragraphs 0033 and 0050-0051, Ye discloses that breath sounds may be analyzed to monitor coughing and to stop the lung therapy with the HFCWO vest when coughing is detected to be above the threshold).
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 method and device of modified Stryker to have the cough sensor being used to deactivate the pressure applicator as taught by Ye for the purpose of providing safety and comfort to the patient by automatically detecting when the patient is coughing and stopping the treatment of the pressure applicator once coughing is detected to be over a threshold to allow the patient to freely cough (see paragraphs 0033 and 0050-0051 of Ye).
Response to Arguments
Applicant’s arguments with respect to claims 51, 53-62, and 71-74 have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
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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/TU A VO/Primary Examiner, Art Unit 3785
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