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 .
Claim Objections
Claim(s) 1-20 is/are objected to because of the following informalities:
Claim 1, Ln. 15 recites “the usual treatment plan” which should read “the usual patient treatment plan” for consistency with Ln. 8
Claim 10, Ln. 3 recites “at least one combination respiratory therapy device” which should read “the at least one combination respiratory therapy device” following after Ln. 1-2
Claim 10, Ln. 7 recites “including combined respiratory therapy prescription” which should read “including a combined respiratory therapy prescription”
Claim 10, Ln. 7 recites “over a prescribed period of time associated” where the word “associated” should be removed
Claim 10, Ln. 12 recites “the usual treatment plan” which should read “the usual patient treatment plan” for consistency with Ln. 6
Claim 14, Ln. 3 recites “a clinician device” which should read “the clinician device” following after Ln. 2
Claim 14, Ln. 24 recites “the usual treatment plan” which should read “the usual patient treatment plan” for consistency with Ln. 9
Claim 17, Ln. 2 recites “by a clinician device” which is unnecessary and should be removed
Claim 17, Ln. 15 ends with the word “receive” which should instead be placed on the following line
Claim 17, Ln. 21 should end with some form of punctuation
Claim 20, Ln. 2 should end with a colon
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.
Claim(s) 1-13 and 17-20 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 1 recites the limitation “configured to return the controller to execution of the usual patient treatment plan … after the user activates a return to usual patient plan command” in Ln. 15-17 which deems the claim indefinite. The claim recites a function, i.e. the user activates a return to usual patient plan command, without clearly linking any of the recited structures of the claim to performance of that function. The claim recites a user being able to activate “a return to usual patient plan command” without reciting what structure is involved in that activation (e.g. an icon, a button, etc.). The claim is thus improper as it attempts to define the structure of the device by what it does rather than what it is (see MPEP 2173.05(g)). Applicant is encouraged to recite in the claim how the user would activate the return to usual patient plan command.
Claim 1 recites the limitation “when an icon is selected by the user” in Ln. 21 which deems the claim indefinite. It is unclear whether the present “icon” is to be understood as further specifying the earlier “icons or buttons” or is to be understood as distinct from the earlier “icons or buttons”. If reference is intended to the prior limitation then it is further unclear why the earlier limitation recites “icons or buttons” while the later limitation only recites “an icon.” Should the later limitation not be read as positively recited since it would not be required if the “buttons” are what are read from the earlier “or” clause? Applicant is requested to clarify the icons/buttons in the final section of the claim.
Claim 10 recites the limitation “configured to return the controller to execution of the usual patient treatment plan … after the user activates a return to usual patient plan command” in Ln. 12-14 which deems the claim indefinite. The claim recites a function, i.e. the user activates a return to usual patient plan command, without clearly linking any of the recited structures of the claim to performance of that function. The claim recites a user being able to activate “a return to usual patient plan command” without reciting what structure is involved in that activation (e.g. an icon, a button, etc.). The claim is thus improper as it attempts to define the structure of the device by what it does rather than what it is (see MPEP 2173.05(g)). Applicant is encouraged to recite in the claim how the user would activate the return to usual patient plan command.
Claim 10 recites the limitation “when an icon is selected by the user” in Ln. 19 which deems the claim indefinite. It is unclear whether the present “icon” is to be understood as further specifying the earlier “icons or buttons” or is to be understood as distinct from the earlier “icons or buttons”. If reference is intended to the prior limitation then it is further unclear why the earlier limitation recites “icons or buttons” while the later limitation only recites “an icon.” Should the later limitation not be read as positively recited since it would not be required if the “buttons” are what are read from the earlier “or” clause? Applicant is requested to clarify the icons/buttons in the final section of the claim.
Claim 10 recites the limitation “the at least one operation” in Ln. 22. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the limitation will be interpreted as reading “at least one operation”.
In claim 17 the scope of the claimed subject matter is unclear due to inconsistencies between the language of the claim preamble and certain portions of the body of the claim. The preamble of claim 17 sets forth the subcombination of a clinician device. However, line 22-32 of the claim recites a set of particular structures and programming of the at least one combination respiratory therapy device which sets forth a positive relationship between the clinician device and the at least one combination respiratory therapy device, and thus the claim appears to claim the combination a system including the clinician device and the at least one combination respiratory therapy device. Applicant needs to amend the language of the claim to be consistent either as a combination or subcombination claim. If the claim is to be a combination, as it is presently recited, then the preamble of the claim should be changed. If the claim is to be a subcombination then the particular structures and programming of the at least one combination respiratory therapy device should be removed from the claim. For the purposes of examination the claim will be interpreted as the combination a system including the clinician device and the at least one combination respiratory therapy device, as the body of the claim has been written.
Claim 18 recites the limitation “the memory” in Ln. 2 which deems the claim indefinite. Claim 17 has recited two different structures including memory but the present limitation fails to specify which of those two structures the present memory is a part of. For the purposes of examination the memory will be interpreted as potentially in either of the structures from claim 17.
Claim 20 recites the limitations “the air pulse generator” and “the blower” both in Ln. 5. There is insufficient antecedent basis for these limitations in the claim. For the purposes of examination the limitations will be interpreted as reading “an air pulse generator of the at least one combination respiratory therapy device” and “a blower of the at least one combination respiratory therapy device,” respectively.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1 and 9-12 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,814,082 in view of Huster et al. (U.S. Pub. 2008/0000477). All limitations of instant claim 1 are found within the overall scope of patent claim 1 with the exception of an on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions activated by a user which are distinct from the usual treatment plan and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command; the graphical user interface including icons or buttons associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user.
Huster teaches a combination respiratory therapy device (Fig. 23; ¶0115) including a blower (Fig. 23 #474; ¶¶0141-0144) and an air pulse generator (Fig. 23 #316; ¶0137). Huster teaches an on-demand immediate respiratory therapy (Fig. 16 options; ¶0127), and the on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions (Fig. 16 options; ¶0127) activated by a user which are distinct from the usual patient treatment plan (the patient’s “normal” may be customized such that it does not match any of the options directly in Fig. 16) and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command (¶¶0149, 0155 – can return to patient specific mode when patient icon 396 selected); a user interface display (Fig. 16) in communication with the controller and configured to display a graphical user interface including icons or buttons (Fig. 16; ¶0127 – touching the associated quadrant of the screen 338) associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user (Fig. 16; ¶0127 – the touched quadrant will activate its associated mode). Huster teaches an on-demand graphical user interface selection as providing the benefit of allowing a caregiver to select from immediate treatment program options as opposed to the patient’s prescribed therapy (¶¶0127-0128).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in patent claim 1 an on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions activated by a user which are distinct from the usual treatment plan and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command; the graphical user interface including icons or buttons associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user in order to provide the benefit of allowing a caregiver to select from immediate treatment program options as opposed to the patient’s prescribed therapy in view of Huster. A further mapping of other claims is as follows:
Instant claim 9 vs. patent claim 1
Instant claim 10 vs. patent claim 1 in view of Huster in the same manner discussed above in regard to claim 1
Instant claim 11 as obvious in view of Huster (¶0126, 0149; Figs. 16 & 18)
Instant claim 12 as obvious in view of Huster (¶0126, 0149; Figs. 16 & 18)
Claim(s) 1-2 and 5-13 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8 and 10 of U.S. Patent No. 12,080,401 in view of Huster et al. (U.S. Pub. 2008/0000477). All limitations of instant claim 1 are found within the overall scope of patent claim 1 with the exception of an on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions activated by a user which are distinct from the usual treatment plan and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command; the graphical user interface including icons or buttons associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user.
Huster teaches a combination respiratory therapy device (Fig. 23; ¶0115) including a blower (Fig. 23 #474; ¶¶0141-0144) and an air pulse generator (Fig. 23 #316; ¶0137). Huster teaches an on-demand immediate respiratory therapy (Fig. 16 options; ¶0127), and the on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions (Fig. 16 options; ¶0127) activated by a user which are distinct from the usual patient treatment plan (the patient’s “normal” may be customized such that it does not match any of the options directly in Fig. 16) and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command (¶¶0149, 0155 – can return to patient specific mode when patient icon 396 selected); a user interface display (Fig. 16) in communication with the controller and configured to display a graphical user interface including icons or buttons (Fig. 16; ¶0127 – touching the associated quadrant of the screen 338) associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user (Fig. 16; ¶0127 – the touched quadrant will activate its associated mode). Huster teaches an on-demand graphical user interface selection as providing the benefit of allowing a caregiver to select from immediate treatment program options as opposed to the patient’s prescribed therapy (¶¶0127-0128).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in patent claim 1 an on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions activated by a user which are distinct from the usual treatment plan and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command; the graphical user interface including icons or buttons associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user in order to provide the benefit of allowing a caregiver to select from immediate treatment program options as opposed to the patient’s prescribed therapy in view of Huster. A further mapping of other claims is as follows:
Instant claim 2 as obvious in view of patent claim 2 – cough icon obviously applied for on-demand purpose
Instant claim 5 vs. patent claim 2
Instant claim 6 vs. patent claim 2
Instant claim 7 vs. patent claim 2
Instant claim 8 vs. patent claim 8
Instant claim 9 vs. patent claim 10
Instant claim 10 vs. patent claim 1 in view of Huster in the same manner discussed above in regard to claim 1
Instant claim 11 vs. patent claim 8
Instant claim 12 vs. patent claim 8
Instant claim 13 vs. patent claim 8
Claim(s) 1 and 8-19 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-12 of copending Application No. 18/737,062 in view of Huster et al. (U.S. Pub. 2008/0000477). All limitations of instant claim 1 are found within the overall scope of reference claim 2 with the exception of specifying the combination respiratory therapy device as including a blower and an air pulse generator; and an on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions activated by a user which are distinct from the usual treatment plan and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command; the graphical user interface including icons or buttons associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user.
Huster teaches a combination respiratory therapy device (Fig. 23; ¶0115) including a blower (Fig. 23 #474; ¶¶0141-0144) and an air pulse generator (Fig. 23 #316; ¶0137). Huster teaches an on-demand immediate respiratory therapy (Fig. 16 options; ¶0127), and the on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions (Fig. 16 options; ¶0127) activated by a user which are distinct from the usual patient treatment plan (the patient’s “normal” may be customized such that it does not match any of the options directly in Fig. 16) and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command (¶¶0149, 0155 – can return to patient specific mode when patient icon 396 selected); a user interface display (Fig. 16) in communication with the controller and configured to display a graphical user interface including icons or buttons (Fig. 16; ¶0127 – touching the associated quadrant of the screen 338) associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user (Fig. 16; ¶0127 – the touched quadrant will activate its associated mode). Huster teaches an on-demand graphical user interface selection as providing the benefit of allowing a caregiver to select from immediate treatment program options as opposed to the patient’s prescribed therapy (¶¶0127-0128).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in reference claim 1 the combination respiratory therapy device as including a blower and an air pulse generator; and an on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions activated by a user which are distinct from the usual treatment plan and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command; the graphical user interface including icons or buttons associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user in order to provide the benefit of 1) using a combination of chest compressions and airway suction to encourage mucus extraction and 2) allowing a caregiver to select from immediate treatment program options as opposed to the patient’s prescribed therapy in view of Huster. A further mapping of other claims is as follows:
Instant claim 8 vs. reference claim 5
Instant claim 9 as obvious in view of Huster (Fig. 23)
Instant claim 10 vs. reference claim 2 in view of Huster in a similar manner discussed above in regard to claim 1, but only specifically to the on-demand operations
Instant claim 11 vs. reference claim 2
Instant claim 12 vs. reference claim 3
Instant claim 13 vs. reference claim 4
Instant claim 14 vs. reference claim 6 in view of Huster in a similar manner discussed above in regard to claim 1, but only specifically to the on-demand operations
Instant claim 15 vs. reference claim 7; the generating of a graphical user interface would further be obvious in view of reference claim 6 since it already recited the clinician device, as a computing structure, as able to make adjustments to the combination respiratory therapy device
Instant claim 16 vs. reference claim 9
Instant claim 17 vs. reference claim 10 in view of Huster in a similar manner discussed above in regard to claim 1, but only specifically to the on-demand operations
Instant claim 18 vs. reference claim 11
Instant claim 19 vs. reference claim 12
This is a provisional nonstatutory double patenting rejection.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huster et al. (U.S. Pub. 2008/0000477) in view of Birnkrant et al. (U.S. Pub. 2014/0150791).
Regarding claim 1, Huster discloses a combination respiratory therapy device (Fig. 23; ¶0115) comprising: a blower (Fig. 23 #474; ¶¶0141-0144) for providing negatively pressurized air to a mouthpiece (¶0141) coupled to a patient's airway; an air pulse generator (Fig. 23 #316; ¶0137) configured for delivering air pulses to at least one of a garment (¶0137 – vest) worn by the patient
Huster fails to disclose the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed by the combination respiratory therapy device over the prescribed period of time.
Birnkrant teaches a combination respiratory therapy device (Fig. 3; ¶0083) including an air pulse generator (Fig. 3 #352; ¶0092) and a blower (Fig. 3 #328; ¶0092). Birnkrant teaches a combined respiratory therapy prescription (e.g. Fig. 3 #118; ¶0087), the combined respiratory therapy prescription defining a plurality of different therapy sessions (¶0014) to be performed by the combination respiratory therapy device over a period of time, each of the plurality of different therapy sessions comprising a mucus extraction therapy (¶0014). Birnkrant teaches this form of therapy as providing the benefit of following an automated prescribed pattern of respiratory treatments which encourage mucus extraction (¶¶0009, 0014-0015).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Huster the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed by the combination respiratory therapy device over the prescribed period of time in order to provide the benefit of following an automated prescribed pattern of respiratory treatments which encourage mucus extraction in view of Birnkrant.
Regarding claim 2, Huster teaches the invention as modified above but alone fails to teach the graphical user interface icons or buttons comprise a cough icon associated with a cough on demand operation of the combination respiratory therapy device and, wherein responsive to a user selection of the cough icon, the controller is configured to operate the air pulse generator to provide immediate inspiratory airflow to the patient and the blower to provide expiratory suction pressure to the patient.
It is initially noted that Huster has an interest in providing cough assist therapy (e.g. ¶0079). Birnkrant teaches a combination respiratory therapy device (Fig. 3; ¶0083) including an air pulse generator (Fig. 3 #352; ¶0092) and a blower (Fig. 3 #328; ¶0092). Birnkrant teaches that a user desiring an immediate cough can activate a finger switch to initiate an assisted cough therapy (¶0091). The assisted cough therapy of Birnkrant includes operating the air pulse generator to provide inspiratory airflow to the patient and the blower to provide expiratory suction pressure to the patient (¶¶0051, 0077-0078). One of ordinary skill in the art would have considered it prima facie obvious that the activation of an assisted cough therapy could have been obviously implemented as initiable through an icon on the graphical user interface of Huster either in addition to the finger switch taught by Birnkrant or as a substitute for the finger switch as the same functionality would be retained but merely with an alternative form of user engagement to initiate the assisted cough therapy. Additionally, it would have been prima facie obvious for any functionality implemented within a therapy prescription of Huster to also be made available to a user for on-demand selection in order to allow real time response to changes in the patient’s condition.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Huster the graphical user interface icons or buttons comprise a cough icon associated with a cough on demand operation of the combination respiratory therapy device and, wherein responsive to a user selection of the cough icon, the controller is configured to operate the air pulse generator to provide immediate inspiratory airflow to the patient and the blower to provide expiratory suction pressure to the patient as the use of a cough icon on the graphical user interface merely represents an obvious design choice alternative of user engagement to initiate the assisted cough therapy already taught by Huster and in view of the on demand finger switch of Birnkrant. Additionally, it would have been prima facie obvious for any functionality implemented within a therapy prescription of Huster, such as a cough assistance procedures, to also be made available to a user for on-demand selection in order to allow real time response to changes in the patient’s condition.
Regarding claim 3, Huster teaches the invention as modified above but alone fails to teach the graphical user interface icons or buttons, comprise an emergency icon associated with an emergency operation of the combination respiratory device, and wherein responsive to a user selection of the emergency icon, the controller is configured to immediately operate the blower and the air pulse generator to provide continuous lung ventilation to the patient.
Birnkrant teaches a combination respiratory therapy device (Fig. 3; ¶0083) including an air pulse generator (Fig. 3 #352; ¶0092) and a blower (Fig. 3 #328; ¶0092). Birnkrant teaches lung ventilation as capable of inclusion within a prescription therapy (e.g. ¶¶0047-0048, 0075, 0078). It would have been prima facie obvious for any functionality implemented within a therapy prescription of Huster to also be made available to a user for on-demand selection in order to allow real time response to changes in the patient’s condition.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Huster the graphical user interface further comprises an emergency icon associated with an emergency operation of the combination respiratory device, and wherein responsive to a selection of the emergency icon, the controller is configured to operate the blower and the air pulse generator to provide continuous lung ventilation to the patient in order to provide the benefit of using the already available structures of Huster to provide lung ventilation when necessary in view of Birnkrant, with one of ordinary skill in the art considering it prima facie obvious for any functionality implemented within a therapy prescription to also be made available to a user for on-demand selection in order to allow real time response to changes in the patient’s condition.
Regarding claim 4, Huster teaches the invention as modified above but fails to expressly teach the graphical user interface icons or buttons comprise an intensify therapy icon associated with an intensify therapy operation of the combination respiratory therapy device, and wherein responsive to a user selection of the intensify therapy icon, the controller is configured to operate the combination respiratory therapy device at a preselected level.
However, Huster teaches a variety of options as part of the therapy prescription which can be increased (e.g. Figs. 17-18; ¶¶0129-0130, 0149), with an increase in treatment parameter directly relatable to an intensification in therapy. The increases in Huster are taught as capable of occurring in preselected increments, which may be read on the preselected levels of the instant claim. It would have been prima facie obvious for any functionality implemented within a therapy prescription of Huster to also be made available to a user for on-demand selection in order to allow real time response to changes in the patient’s condition.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Huster the graphical user interface further comprises an intensify therapy icon associated with an intensify therapy operation of the combination respiratory therapy device, and wherein responsive to a selection of the intensify therapy icon, the controller is configured to operate the combination respiratory therapy device at a preselected level as the functionality of intensifying therapy is already taught by Huster, with one of ordinary skill in the art considering it prima facie obvious for any functionality implemented within a therapy prescription of Huster, such as intensifying therapy, to also be made available to a user for on-demand selection in order to allow real time response to changes in the patient’s condition.
Regarding claim 5, Huster teaches the invention as modified above and further teaches the graphical user interface icons or buttons comprise a customization icon (Fig. 16; ¶¶0127-0128) associated with a customization of a therapy operation of the combination respiratory therapy device.
Huster teaches the invention as modified above but fails to expressly teach and wherein responsive to a user selection of the customization icon, the controller is configured to sequentially generate a series of screens associated with operations of the combination respiratory therapy device.
However, Huster does teach parameters in the customization are adjustable (e.g. ¶0128 – wave type, frequency, pressure, and timing parameters). One of ordinary skill in the art would have considered it prima facie obvious for selection of those adjustable parameters to be made available to a user across a series of sequential screens which individually addressed each adjustable parameter, as touchscreen interfaces are a form of user interface which commonly allows customized option selection in the form of sequential screens.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Huster responsive to a user selection of the customization icon, the controller is configured to sequentially generate a series of screens associated with operations of the combination respiratory therapy device as the use of sequential screens merely represents an obvious design choice option of user engagement to allow the user to select the adjustable customization parameters desired by Huster.
Regarding claim 6, Huster further suggests as obvious the graphical user interface, responsive to the user selection of the customization icon, displays a cough inspiratory pressure adjustment screen including icons for low pressure, normal pressure, and high pressure (Fig. 17; ¶¶0129-0130). Huster teaches that pressure can be selected within a defined range and one of ordinary skill in the art would have considered it prima facie obvious that the range could be readily implemented in a set of three icons representative of ends and a middle of that range. The specific icons of the claim do not patentably distinguish the overall functionality of the claim over Huster.
Regarding claim 7, Huster further suggests as obvious the graphical user interface, responsive to the user selection of at least one of the low, normal or high icons of the cough inspiratory pressure adjustment screen, displays a cough expiratory (suction) pressure adjustment screen including icons for low pressure, normal pressure, and high pressure (Fig. 17; ¶¶0129-0130). Similar to the discussion in claim 6 above Huster teaches that pressure can be selected within a defined range and one of ordinary skill in the art would have considered it prima facie obvious that the range could be readily implemented in a set of three icons representative of ends and a middle of that range. While the illustration in Fig. 17 is only specific to a vest pressure one of ordinary skill in the art would have considered it prima facie obvious that in the cited embodiment of Fig. 23 pressure would also be selectable for providing to the mouthpiece. The specific icons of the claim do not patentably distinguish the overall functionality of the claim over Huster.
Regarding claim 9, Huster teaches the invention as modified above and further teaches the blower and the air pulse generator are resident on physically separate circuits (Fig. 23 – no fluid communication between vacuum pump 474 and air pulse generator 316).
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birnkrant et al. (U.S. Pub. 2014/0150791) in view of Huster et al. (U.S. Pub. 2008/0000477).
Regarding claim 10, Birnkrant discloses a system (Fig. 11; ¶¶0107-0116) for control of at least one combination respiratory therapy device (Fig. 11 #110; ¶0107), comprising: the at least one combination respiratory therapy device comprising: a network interface (Fig. 11 network connection; Fig. 3 #384; ¶0090) in communication with an associated computer network (Fig. 11 network; ¶¶0107-0116), a controller (Fig. 3 #310; ¶0087) including a processor (¶0087) in communication with memory (Fig. 3 #312; ¶0087) storing instructions which are executable by the processor to execute a 1) usual patient treatment plan including a combined respiratory therapy prescription over a prescribed period of time (¶¶0014, 0087 – prescription) and 2) an on-demand immediate respiratory therapy (¶0091 – via finger switch interaction), the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed by the combination respiratory therapy device over the prescribed period of time (¶0014); and a user interface display (Fig. 3 #318, 320; ¶¶0088-0089) in communication with the controller and configured to display a graphical user interface (¶0088 – touchscreen); and at least one clinician computing device (Fig. 11 #1110; ¶0108) in communication with the at least one combination respiratory therapy device via the associated computer network (Fig. 11) and configured to control at least one operation of the at least one combined respiratory therapy device (e.g. ¶¶0109, 0115). The phrasing “combination respiratory therapy device” is not a term of art and is thus interpreted in light of the specification as referring to a device able to provide both for providing negatively pressurized air to a patient's airway and for delivering air pulses to at least one of a garment worn by the patient or the patient's airway (e.g. ¶0005). The term “usual” is defined in the specification as referring to a prescription for combination respiratory therapy which is a usual treatment plan for the patient (¶0123). The term “usual” is thus understood in contrast to the term “on-demand” in the claim. The claim is afforded an effective filing date of 25 Sep 2020 based at least upon its particularly claimed “on-demand” options.
Birnkrant fails to disclose the on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions activated by a user which are distinct from the usual treatment plan and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command; the graphical user interface including icons or buttons associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user.
Huster teaches a combination respiratory therapy device (Fig. 23; ¶0115) including a blower (Fig. 23 #474; ¶¶0141-0144) and an air pulse generator (Fig. 23 #316; ¶0137). Huster teaches an on-demand immediate respiratory therapy (Fig. 16 options; ¶0127), and the on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions (Fig. 16 options; ¶0127) activated by a user which are distinct from the usual patient treatment plan (the patient’s “normal” may be customized such that it does not match any of the options directly in Fig. 16) and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command (¶¶0149, 0155 – can return to patient specific mode when patient icon 396 selected); a user interface display (Fig. 16) in communication with the controller and configured to display a graphical user interface including icons or buttons (Fig. 16; ¶0127 – touching the associated quadrant of the screen 338) associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user (Fig. 16; ¶0127 – the touched quadrant will activate its associated mode). Huster teaches an on-demand graphical user interface selection as providing the benefit of allowing a caregiver to select from immediate treatment program options as opposed to the patient’s prescribed therapy (¶¶0127-0128).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Birnkrant the on-demand immediate respiratory therapy including a plurality of different on-demand immediate respiratory therapy sessions activated by a user which are distinct from the usual treatment plan and are configured to return the controller to execution of the usual patient treatment plan after execution of the on-demand immediate therapy or after the user activates a return to usual patient plan command; the graphical user interface including icons or buttons associated with the plurality of different on-demand immediate respiratory therapy sessions and configured to activate an on-demand immediate respiratory therapy session when an icon is selected by the user in order to provide the benefit of allowing a caregiver to select from immediate treatment program options as opposed to the patient’s prescribed therapy in view of Huster.
Regarding claim 11, Birnkrant teaches the invention as modified above and Huster as incorporated therein further teaches the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations (Huster – ¶0126, 0149 – selectable icons for different therapy options; see also the icons of Figs. 16 & 18) of the at least one combined respiratory therapy device, and wherein selection of one of the plurality of icons controls the at least one combined respiratory therapy device to perform the corresponding one of the plurality of operations.
Regarding claim 12, Birnkrant teaches the invention as modified above and Huster as incorporated therein further teaches the selection of one of the plurality of icons is received via the user interface display (Huster – icons of Figs. 16 & 18 allow user selection).
Regarding claim 13, Birnkrant teaches the invention as modified above and further teaches the at least one clinician computing device further comprises a graphical user interface corresponding to the graphical user interface of the at least one combined respiratory therapy device (¶¶0035, 0109 – module 114 with prescription creator module 112 can be located on both the combination respiratory therapy device and the physician computing device).
Allowable Subject Matter
Claim(s) 8 and 17-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim(s) 14-16 are allowed over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, Huster fails to teach or suggest the graphical user interface includes a plurality of icons associated with a corresponding plurality of operations of the combination respiratory therapy device, and wherein the controller is configured to receive a selection of at least one of the plurality of icons from at least one of a physician computing device or a therapist computing device via the network interface.
While Huster teaches the combination respiratory therapy device in communication over a network there is no teaching or suggestion in Huster that icons on the graphical user interface of the combination respiratory therapy would be selectable remotely by an external computing device.
It is noted the claim includes the same general limitations as were indicated allowable of claim 16 in parent application 17/023,328 (see Pg. 18-19 of Final Office action mailed 12 Apr 2024).
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 14, the prior art fails to teach or suggest a method for remotely controlling at least one combination respiratory therapy device by a clinician device including all steps, elements and functionality recited by the instant claim. It is initially noted that the phrasing “combination respiratory therapy device” is not a term of art and is thus interpreted in light of the specification as referring to a device able to provide both for providing negatively pressurized air to a patient's airway and for delivering air pulses to at least one of a garment worn by the patient or the patient's airway (e.g. ¶0005). The term “usual” is defined in the specification as referring to a prescription for combination respiratory therapy which is a usual treatment plan for the patient (¶0123).
Of particular note the clinician device includes an associated display at which are received selection data corresponding to a selected therapy adjustment to a usual patient treatment plan, and activation buttons corresponding to on-demand immediate respiratory therapy. The selected therapy adjustment or the on-demand immediate respiratory therapy to the at least one combination respiratory therapy device are then communicated to the at least one combination respiratory therapy device. The claim thus requires a display interface on the clinician device which is usable to control both the usual patient treatment plan as well as on-demand immediate therapy requests. The prior art is not found to teach or suggest remote control of a combination respiratory therapy device by a clinician device in regard to both ongoing treatment as well as on-demand patient treatment.
The claim is afforded an effective filing date of 25 Sep 2020 based at least upon its particularly claimed “on-demand” options.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 17, the claim is found allowable over the prior art for the same general reasons discussed above in regard to claim 14. Note is made of the above 35 U.S.C. 112(b) interpretation of the claim and the accompanying interpretation of the claim as a combination of the clinician device and the at least one combination respiratory therapy device.
The phrasing “combination respiratory therapy device” is not a term of art and is thus interpreted in light of the specification as referring to a device able to provide both for providing negatively pressurized air to a patient's airway and for delivering air pulses to at least one of a garment worn by the patient or the patient's airway (e.g. ¶0005). The term “usual” is defined in the specification as referring to a prescription for combination respiratory therapy which is a usual treatment plan for the patient (¶0123). The term “usual” is thus understood in contrast to the term “on-demand” in the claim. The claim is afforded an effective filing date of 25 Sep 2020 based at least upon its particularly claimed “on-demand” options.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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