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) 1-12 is/are objected to because of the following informalities:
Claim 1, 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 6, Ln. 3 recites “a clinician device” which should read “the clinician device” following after Ln. 2
Claim 6, Ln. 10-11 recites “the at least one combination therapy device” which should read “the at least one combination respiratory therapy device” following after Ln. 1-2
Claim 10, Ln. 2 recites “by a clinician device” which is unnecessary and should be removed
Claim 10, Ln. 5 recites “with at least one combination respiratory therapy device” which should read “with the at least one combination respiratory therapy device” following after Ln. 1-2
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) 1-5 and 9 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 “system for problem-first device control” in Ln. 1 which deems the claim indefinite. It is unclear what is intended by the phrasing “problem-first device control”. One of ordinary skill in the art would be left to question what “problem” is being addressed? And how is “problem-first” control to be distinguished from other forms of control? Applicant is requested to clarify the language “problem-first device control”.
Claim 1 recites the limitation “the at least one combination respiratory therapy device comprising …” in Ln. 3-12 which deems the claim indefinite. The phrasing “combination respiratory therapy device” seems to imply this device within the claimed system must have some structure able to provide different forms of respiratory therapy. However, the claim only positively recites structures for the combination respiratory therapy device which are not directly part of providing respiratory therapy (i.e. network interface, controller and display). It is thus unclear in the limitation as claimed whether the language “combination respiratory therapy device” is only to be considered as functionally suggestive of interface of the combination respiratory therapy device with other structures which provide combination respiratory therapy or whether the language “combination respiratory therapy device” is to be understood as giving life to the claim to imply structures which provide combination respiratory therapy beyond what structure is explicitly recited in the claim. Because the claim has positively recited the combination respiratory therapy device and not merely a set of electronic structures to interact with a combination respiratory therapy device it appears applicant was intending to positively the recite structures which provide combination respiratory therapy. For the present time the limitation will be interpreted as presented to allow for maximum breadth of examination.
Claim 9 recites the limitation “the graphical user interface” in Ln. 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the claim will instead be read as dependent on claim 8, which provides the proper antecedent basis.
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) 1-3 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 the at least one combination respiratory therapy device including a display in communication with the controller and configured to display a graphical user interface associated with at least one operation of the combination respiratory therapy device.
Huster teaches a combination respiratory therapy device (Figs. 12-15 #300; ¶0110) comprising a display (e.g. Fig. 16 #330; ¶¶0116, 0127) in communication with a controller and configured to display a graphical user interface (e.g. Fig. 16 #330; ¶0127) associated with at least one operation of the combination respiratory therapy device. Huster teaches a display as providing the benefit of applying a display which allows control of operation of the combination respiratory therapy device (¶0116).
It would have been prima facie obvious to one having ordinary skill in the art at the time of the effective filing of the invention to have incorporated in patent claim 1 the at least one combination respiratory therapy device including a display in communication with the controller and configured to display a graphical user interface associated with at least one operation of the combination respiratory therapy device in order to provide the benefit of applying a display which allows control of operation of the combination respiratory therapy device in view of Huster. A further mapping of dependent claims is as follows:
Instant claim 2 as obvious in view of Huster (¶0126, 0149)
Instant claim 3 as obvious in view of Huster (¶0126, 0149)
Claim(s) 1-12 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-19 of copending Application No. 18/737,062 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all requirements of instant claim 1 are found within the overall scope of reference claim 10, the instant claim merely being broader in scope. Similarly, all requirements of instant claim 6 are found within the overall scope of reference claim 14, the instant claim merely being broader in scope. Additionally, all requirements of instant claim 10 are found within the overall scope of reference claim 17, the instant claim merely being broader in scope. A further mapping of dependent claims is as follows:
Instant claim 2 vs. reference claim 11
Instant claim 3 vs. reference claim 12
Instant claim 4 vs. reference claim 13
Instant claim 5 as obvious in view of reference claim 13 – the corresponding display will obviously include selectable icons to be communicated to the combination respiratory therapy device
Instant claim 7 vs. reference claim 15
Instant claim 8 vs. reference claim 15
Instant claim 9 vs. reference claim 16
Instant claim 11 vs. reference claim 18
Instant claim 12 vs. reference claim 19
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huster et al. (U.S. Pub. 2008/0000477) in view of D’Angelo et al. (U.S. Pub. 2014/0102455).
Regarding claim 1, Huster discloses a system (Figs. 12-15; ¶¶0110, 0167) for problem-first device control of at least one combination respiratory therapy device (Figs. 12-15 #300; ¶0110), comprising: the at least one combination respiratory therapy device (Figs. 12-15 #300; ¶0110) comprising: a network interface (¶0167 – system 300 may be coupled either wirelessly and/or via wires to a network of computer devices) in communication with an associated computer network, a controller (Figs. 22-23 #318; ¶¶0140, 0142) including a processor (¶0114 – circuit board) in communication with memory (¶0131) storing instructions which are executable by the processor to execute a combined respiratory therapy prescription (¶0012 – stores operating parameters for a plurality of patients), the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed by the combination respiratory therapy device over a period of time (¶0012 – individual sessions can each individual patient), and a display (e.g. Fig. 16 #330; ¶¶0116, 0127) in communication with the controller and configured to display a graphical user interface (e.g. Fig. 16 #330; ¶0127) associated with at least one operation of the combination respiratory therapy device; and at least one clinician computing device (¶0167 – within healthcare facility network) in communication with the at least one combination respiratory therapy device via the associated computer network (¶0167). The claim is afforded full priority dating and thus has an effective filing date of 03 Dec 2012.
Huster fails to disclose the at least one clinician computing device configured to control the at least one operation of the at least one combined respiratory therapy device.
D’Angelo teaches a respiratory therapy device (Fig. 1 #14; ¶0023) and a clinician computing device (Fig. 1 #16; ¶0024) configured to control the at least one operation of the respiratory therapy device (¶¶0049, 0052-0053). D’Angelo teaches remote clinician control of a respiratory therapy device as providing the benefit of allowing a clinician to remotely manage operation of multiple respiratory therapy devices (¶¶0031, 0049).
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 at least one clinician computing device configured to control the at least one operation of the at least one combined respiratory therapy device in order to provide the benefit of allowing a clinician to remotely manage operation of multiple respiratory therapy devices in view of D’Angelo.
Regarding claim 2, Huster teaches the invention as modified above and together with D’Angelo 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; D’Angelo – ¶¶0049, 0053 – different selectable therapy mode fields) 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 3, Huster teaches the invention as modified above and further teaches the selection of one of the plurality of icons is received via the display (e.g. Fig. 18; ¶¶0126, 0149).
Regarding claim 4, Huster teaches the invention as modified above and D’Angelo further suggests as obvious 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 (¶¶0049, 0053 – different selectable therapy mode fields).
Regarding claim 5, Huster teaches the invention as modified above and D’Angelo further teaches the selection of one of the plurality of icons is received via the graphical user interface of the at least one clinician computing device by the at least one combined respiratory therapy device over the associated computer network (¶¶0049, 0053 –selected therapy mode sent to respiratory device).
Claim(s) 2-5 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 2, Birnkrant discloses a system (e.g. Fig. 11; ¶¶0107-0116) for problem-first device control of at least one combination respiratory therapy device (Fig. 3; ¶0083), comprising: the at least one combination respiratory therapy device (Fig. 3; ¶0083) comprising: a network interface Fig. 3 #384; ¶0090) in communication with an associated computer network (Fig. 11 network), 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 combined respiratory therapy prescription (e.g. Fig. 3 #118; ¶0087), the combined respiratory therapy prescription defining a plurality of different therapy sessions to be performed by the combination respiratory therapy device over a period of time (¶0014), and a display (Fig. 3 #320; ¶0088) in communication with the controller and configured to display a graphical user interface (¶0088 – touchscreen) associated with at least one operation of the combination respiratory therapy device; 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 the at least one operation of the at least one combined respiratory therapy device (¶¶0109, 0115 – adjust the patient's current therapy prescription). As the icons and their selection are not supported by the earliest priority document the claim is afforded an effective filing date of 25 Sep 2020.
Birnkrant fails to disclose the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations 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.
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 a user interface display (Fig. 16) in communication with the controller and configured to display a graphical user interface including a plurality of icons (Fig. 16; ¶0127 – touching the associated quadrant of the screen 338) corresponding to a plurality of operations 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 (Fig. 16; ¶0127 – the touched quadrant will activate its associated mode). Huster teaches a 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 graphical user interface further comprises a plurality of icons corresponding to a plurality of operations 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 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 3, 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 display (e.g. Fig. 18; ¶¶0126, 0149).
Regarding claim 4, 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).
Regarding claim 5, Birnkrant teaches the invention as modified above and further teaches the selection of one of the plurality of icons is received via the graphical user interface of the at least one clinician computing device by the at least one combined respiratory therapy device over the associated computer network (¶¶0035, 0109 – prescription selections via prescription creator module 112).
Claim(s) 6 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over D’Angelo et al. (U.S. Pub. 2014/0102455) in view of Huster et al. (U.S. Pub. 2008/0000477).
Regarding claim 6, D’Angelo discloses a method for remotely controlling at least one respiratory therapy device (Fig. 1 #14; ¶0023) by a clinician device (Fig. 1 #16; ¶0024), the method comprising: receiving, at the clinician device in data communication with the at least one respiratory therapy device, patient data representative of at least one physiological parameter associated with a patient (¶¶0038-0041, 0049-0054 – trigger event data); an associated display of the clinician device (Fig. 1 #16 has a display); receiving, via the associated display, selection data corresponding to a selected therapy adjustment (¶¶0049, 0052-0053 – different selectable therapy mode fields); and communicating the selected therapy adjustment to the at least one respiratory therapy device (¶¶0049, 0053 – selected therapy mode sent to respiratory device), wherein the clinician device includes a processor in communication with memory storing instructions which are executed by the processor, causing the processor to perform the method (standard operation of a computer in the form of Fig. 1 #16). As the structures and operations of the clinician device are not supported by the earliest priority document the claim is afforded an effective filing date of 25 Sep 2020.
D’Angelo fails to discloses the at least one respiratory therapy device is a combination respiratory therapy device; generating on the associated display a graphical representation of the received patient data. 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).
Regarding the graphical representation of the received patient data it is noted that client computing platform 16 of D’Angelo is of a conventional form in the computer arts (Fig. 1; ¶0024). One of ordinary skill in the art would have considered it prima facie that any data received by a standard computer could be applied as a graphical representation using common software. It is noted that the claim does not use the graphical representation in any particular manner and thus the graphical representation holds no particular importance in the claim.
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 D’Angelo generating on the associated display a graphical representation of the received patient data based upon the commonly recognized practice in the computer arts of taking received data and presenting that data as a graphical representation using common software.
Huster teaches a combination respiratory therapy device (Figs. 12-15 #300; ¶0110) which includes network communication capability (¶0167). Huster teaches a combination respiratory therapy device as providing the benefit of offering the versatility in a singular device of such therapy options as HFCWO therapy, a positive expiratory pressure (PEP) therapy, a nebulizer therapy, an intermittent positive pressure breathing (IPPB) therapy, a cough assist therapy and a bronchial dilator therapy (¶0005).
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 substituted in D’Angelo the at least one respiratory therapy device is a combination respiratory therapy device in order to provide the benefit of offering the versatility in a singular device of such therapy options as HFCWO therapy, a positive expiratory pressure (PEP) therapy, a nebulizer therapy, an intermittent positive pressure breathing (IPPB) therapy, a cough assist therapy and a bronchial dilator therapy in view of Huster.
Regarding claim 8, D’Angelo teaches the invention as modified above and further suggests as obvious generating, on the associated display of the clinician device, a graphical user interface associated with at least one operation of the at least one combination respiratory therapy device (¶¶0049, 0053 – different selectable therapy mode fields).
Regarding claim 9, D’Angelo teaches the invention as modified above and further teaches the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations 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 (¶¶0049, 0053 –selected therapy mode sent to respiratory device).
Claim(s) 6 and 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birnkrant et al. (U.S. Pub. 2014/0150791).
Regarding claim 6, Birnkrant discloses a method for remotely controlling (Fig. 11; ¶¶0107-0116) at least one combination respiratory therapy device (Fig. 11 #110; ¶0107) by a clinician device (Fig. 11 #1110; ¶0108), the method comprising: receiving, at the clinician device in data communication with the at least one combination respiratory therapy device (e.g. Fig. 11; ¶¶0087, 0090, 0109 – data sharing across network between devices); an associated display of the clinician device (Fig. 11 #1120; ¶0112); receiving, via the associated display, selection data corresponding to a selected therapy adjustment (¶¶0109, 0115 – adjust the patient's current therapy prescription); and communicating the selected therapy adjustment to the at least one combination respiratory therapy device (¶¶0109, 0115 – adjusted prescription sent to the combination respiratory device), wherein the clinician device includes a processor (Fig. 11 #1112) in communication with memory (Fig. 11 #1114) storing instructions which are executed by the processor, causing the processor to perform the method (Fig. 11; ¶¶0107-0116). As the structures and operations of the clinician device are not supported by the earliest priority document the claim is afforded an effective filing date of 25 Sep 2020. 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).
Birnkrant fails to disclose receiving patient data representative of at least one physiological parameter associated with a patient; generating on the associated display a graphical representation of the received patient data.
However, Birnkrant teaches data generated by the device 110 during operation as being communicated across the network (¶0090). Further, Birnkrant teaches pressure sensor 346 as operable to detect initiation of a breath by the patient (¶0093), which may be considered as a physiological parameter. One of ordinary skill in the art would thus have considered it prima facie obvious for the data accumulated by pressure sensor 346 to be among the data generated by the device 110 during operation which would be obviously expected to be communicated to physician computing device 1110 over the network of Fig. 11. Further, regarding the graphical representation of the received patient data it is noted that physician computing device 1110 of Birnkrant includes an output device 1120 which can be of the form of a display screen (¶0112). One of ordinary skill in the art would have considered it prima facie that any data received by a standard computer, such as physician computing device 1110, could be applied as a graphical representation using common software. It is noted that the claim does not use the graphical representation in any particular manner and thus the graphical representation holds no particular importance in the claim.
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 receiving patient data representative of at least one physiological parameter associated with a patient; generating on the associated display a graphical representation of the received patient data based firstly upon an obvious decision to include data accumulated by pressure sensor 346 to be among the data generated by the device 110 during operation which would be obviously expected to be communicated to physician computing device 1110 over the network of Fig. 11 of Birnkrant and based secondly upon the commonly recognized practice in the computer arts of taking received data and presenting that data as a graphical representation using common software.
Regarding claim 8, Birnkrant teaches the invention as modified above and further teaches generating, on the associated display of the clinician device, a graphical user interface associated with at least one operation of the at least one combination respiratory therapy device (¶0109 – prescription creator module).
Regarding claim 9, Birnkrant teaches the invention as modified above and further suggests as obvious the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations 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 (¶¶0036, 0043, 0109 – prescription creator module options).
Regarding claim 10, Birnkrant discloses a clinician device (Fig. 11 #1110; ¶0108) for remotely controlling at least one combination respiratory therapy device (Fig. 11 #110; ¶0107), the clinician device comprising: a processor (Fig. 11 #1112) in communication with memory (Fig. 11 #1114); a network interface (Fig. 11 network connection) in communication with the processor and configured to communicate with the at least one combination respiratory therapy device via an associated computer network (Fig. 11 network; ¶¶0107-0116); and a display (Fig. 11 #1120; ¶0112) in communication with the processor and configured to display a graphical user interface associated with at least one operation of the at least one respiratory therapy device (¶0109 – prescription creator module), wherein the memory stores instructions which are executed by the processor, causing the processor to: receive, via the associated network, data (e.g. Fig. 11; ¶¶0087, 0090, 0109 – data sharing across network between devices); receive, via the display, selection data corresponding to a selected therapy adjustment (¶¶0109, 0115 – adjust the patient's current therapy prescription); and communicate the selected therapy adjustment to the at least one respiratory therapy device via the associated computer network (¶¶0109, 0115 – adjusted prescription sent to the combination respiratory device). As the structures and operations of the clinician device are not supported by the earliest priority document the claim is afforded an effective filing date of 25 Sep 2020. 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).
Birnkrant fails to disclose receiving patient data representative of at least one physiological parameter associated with a patient of the at least one combination respiratory therapy device; and generating, on the display, a graphical representation of the received patient data.
However, Birnkrant teaches data generated by the device 110 during operation as being communicated across the network (¶0090). Further, Birnkrant teaches pressure sensor 346 as operable to detect initiation of a breath by the patient (¶0093), which may be considered as a physiological parameter. One of ordinary skill in the art would thus have considered it prima facie obvious for the data accumulated by pressure sensor 346 to be among the data generated by the device 110 during operation which would be obviously expected to be communicated to physician computing device 1110 over the network of Fig. 11. Further, regarding the graphical representation of the received patient data it is noted that physician computing device 1110 of Birnkrant includes an output device 1120 which can be of the form of a display screen (¶0112). One of ordinary skill in the art would have considered it prima facie that any data received by a standard computer, such as physician computing device 1110, could be applied as a graphical representation using common software. It is noted that the claim does not use the graphical representation in any particular manner and thus the graphical representation holds no particular importance in the claim.
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 receiving patient data representative of at least one physiological parameter associated with a patient of the at least one combination respiratory therapy device; and generating, on the display, a graphical representation of the received patient data based firstly upon an obvious decision to include data accumulated by pressure sensor 346 to be among the data generated by the device 110 during operation which would be obviously expected to be communicated to physician computing device 1110 over the network of Fig. 11 of Birnkrant and based secondly upon the commonly recognized practice in the computer arts of taking received data and presenting that data as a graphical representation using common software.
Regarding claim 11, Birnkrant teaches the invention as modified above and further teaches the memory further stores instructions capable of establishing
Regarding claim 12, Birnkrant teaches the invention as modified above and further suggests as obvious the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations 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 (¶¶0036, 0043, 0109 – prescription creator module options).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over D’Angelo et al. (U.S. Pub. 2014/0102455) in view of Huster et al. (U.S. Pub. 2008/0000477) and further in view of Schindhelm et al. (U.S. Pub. 2013/0340758).
Regarding claim 7, D’Angelo teaches the invention as modified above but fails to teach establishing at least one of a video or an audio communication between the clinician device and the at least one combination respiratory therapy device.
Schindhelm teaches a respiratory therapy device (Fig. 1) which responds to a clinical alert situation by generate an automated voice phone call message to a clinician or physician (¶0061). It is noted that one of the forms which client computing platform 16 of D’Angelo can have is a smartphone (¶0024).
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 D’Angelo establishing an audio communication between the clinician device and the at least one combination respiratory therapy device in order to provide the benefit of generating an automated voice phone call message to a clinician or physician when a clinical alert situation is detected by the combination respiratory therapy device in view of Schindhelm.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birnkrant et al. (U.S. Pub. 2014/0150791) in view of Schindhelm et al. (U.S. Pub. 2013/0340758).
Regarding claim 7, Birnkrant as modified fails to teach establishing at least one of a video or an audio communication between the clinician device and the at least one combination respiratory therapy device.
Schindhelm teaches a respiratory therapy device (Fig. 1) which responds to a clinical alert situation by generate an automated voice phone call message to a clinician or physician (¶0061). It is noted that one of the forms which client computing platform 16 of D’Angelo can have is a smartphone (¶0024).
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 Birnkrant establishing an audio communication between the clinician device and the at least one combination respiratory therapy device in order to provide the benefit of generating an automated voice phone call message to a clinician or physician when a clinical alert situation is detected by the combination respiratory therapy device in view of Schindhelm.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over D’Angelo et al. (U.S. Pub. 2014/0102455) either alone or in view of Huster et al. (U.S. Pub. 2008/0000477).
Regarding claim 10, D’Angelo discloses a clinician device (Fig. 1 #16; ¶0024) for remotely controlling at least one respiratory therapy device (Fig. 1 #14; ¶0023), the clinician device comprising: a processor (¶0024) in communication with memory (¶0024); a network interface (Fig. 1 #16 with network; ¶¶0024, 0026) in communication with the processor and configured to communicate with the at least one respiratory therapy device via an associated computer network (Fig. 1 network; ¶¶0024, 0026); and a display (Fig. 1 #16 has display; ¶0024) in communication with the processor and configured to display a graphical user interface associated with at least one operation of the at least one respiratory therapy device (¶¶0049, 0053 – different selectable therapy mode fields), wherein the memory stores instructions which are executed by the processor, causing the processor to: receive, via the associated network, patient data representative of at least one physiological parameter associated with a patient of the at least one respiratory therapy device (¶¶0038-0041, 0049-0054 – trigger event data); receive, via the display, selection data corresponding to a selected therapy adjustment (¶¶0049, 0052-0053 – different selectable therapy mode fields); and communicate the selected therapy adjustment to the at least one respiratory therapy device via the associated computer network (¶¶0049, 0053 – selected therapy mode sent to respiratory device). As the structures and operations of the clinician device are not supported by the earliest priority document the claim is afforded an effective filing date of 25 Sep 2020.
D’Angelo fails to discloses the at least one respiratory therapy device is a combination respiratory therapy device; and generating, on the display, a graphical representation of the received patient data. 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).
Regarding the graphical representation of the received patient data it is noted that client computing platform 16 of D’Angelo is of a conventional form in the computer arts (Fig. 1; ¶0024). One of ordinary skill in the art would have considered it prima facie that any data received by a standard computer could be applied as a graphical representation using common software. It is noted that the claim does not use the graphical representation in any particular manner and thus the graphical representation holds no particular importance in the claim.
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 D’Angelo generating, on the display, a graphical representation of the received patient data based upon the commonly recognized practice in the computer arts of taking received data and presenting that data as a graphical representation using common software.
Regarding the language at least one “combination” respiratory therapy device it is noted that the at least one combination respiratory therapy device is not positively recited by the claim. As the claimed operations of the clinician device are in no way specific to the operation of a combination respiratory therapy device as opposed to any other form of respiratory therapy device the recitations relating to the at least one combination respiratory therapy device appear to only establish a context for the invention and not to impart meaningful limitations to the claim. Thus, in a first consideration D’Angelo is believed to be “capable of” remotely controlling a combination respiratory therapy device when considering the breadth and generality with which the claim recites the combination respiratory therapy device.
In a second consideration Huster teaches a combination respiratory therapy device (Figs. 12-15 #300; ¶0110) which includes network communication capability (¶0167). Huster teaches a combination respiratory therapy device as providing the benefit of offering the versatility in a singular device of such therapy options as HFCWO therapy, a positive expiratory pressure (PEP) therapy, a nebulizer therapy, an intermittent positive pressure breathing (IPPB) therapy, a cough assist therapy and a bronchial dilator therapy (¶0005).
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 substituted in D’Angelo the at least one respiratory therapy device is a combination respiratory therapy device in order to provide the benefit of offering the versatility in a singular device of such therapy options as HFCWO therapy, a positive expiratory pressure (PEP) therapy, a nebulizer therapy, an intermittent positive pressure breathing (IPPB) therapy, a cough assist therapy and a bronchial dilator therapy in view of Huster.
Regarding claim 11, D’Angelo teaches the invention as modified above and further teaches the memory further stores instructions capable of establishing
Regarding claim 12, D’Angelo teaches the invention as modified above and further teaches the graphical user interface further comprises a plurality of icons corresponding to a plurality of operations 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 (¶¶0049, 0053 – selected therapy mode sent to respiratory device).
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. Additional note is made of Be’eri (U.S. Pub. 2007/0186928) and its teaching a combined insufflation and exsufflation respiratory therapies (e.g. Fig. 1).
It is noted that Birnkrant et al. (U.S. Pub. 2014/0150791) does not qualify as prior art against claim 1 because of its earlier effective filing date (than claims 6 and 10) or 03 Dec 2012. All other claims have an effective filing date of 25 Sep 2020.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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