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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “power module” and “communication module” in claim 21.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, the corresponding structure for “power module” is found in Paragraph [063] and the corresponding structure for “communication module” is found in Paragraphs [066-068] of Applicant’s specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 27 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 recites the limitation "the anchor component” in line 1, however there is no mention of an anchor component presented in claim 21, of which claim 27 is dependent upon. Therefore, there is insufficient antecedent basis for this limitation in the claim. For the purpose of Examination, the Examiner will consider the “anchor component” as being the anchor component that claim 24 recites.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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) 21, 23, 25-26, 28 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Hughes (US 2007/0113843 A1) in view of Flickinger (US 2016/0339188 A1).
Regarding claim 21, Hughes teaches a system for respiratory system secretion management (active respiratory therapeutic device for clearing breathing passages loosening and breaking up mucus plugs and phlegm in a patients sinuses, trachea, bronchial passages and lungs, Abstract), comprising: an external housing (external housing 102, Figure 8 and Paragraph 0030); an oscillatory wave generator (OWG) (acoustic signal generator 108, Figure 6; produces a series of acoustic waveforms, Paragraph 0040), housed in the external housing (see acoustic signal generator 108 housed within housing 102, Figure 6), for generating a wave for loosening secretion from a respiratory system of a subject (acoustic signal generator 108, Figure 6; produces a series of acoustic waveforms to loosening and breaking up mucus plugs in a patients sinuses, Paragraph 0040 and Abstract); an intranasal module in communication with the OWG (mouthpiece 300 may replace the mouthpiece 112 shown in Figure 1, the remainder of the apparatus 100 remains the same, mouthpiece 300 is inserted into a patient’s nostril rather than the patient’s mouth, Paragraph 0049 and Figures 9-10; acoustic vibrations pass though the acoustic coupling chamber 110 into the patient’s nose via mouthpiece, Paragraph 0012), for delivering the wave into a nasal passage of the subject (acoustic vibrations pass though the acoustic coupling chamber 110 into the patient’s nose or other delivery site via mouthpiece 300, Paragraph 0012); a power module configured to power the system (power supply is a rechargeable battery 142, Paragraph 0037); a communication module coupled to at least one of the intranasal module and the OWG (microprocessor 128, Paragraph 0037 and Figure 6, microprocessor is coupled to the mouthpiece via acoustic coupling chamber 110, Paragraph 0012), for selectively communicating power and/or one or more waveform characteristics to the respective intranasal module and/or oscillatory wave generator (microprocessor 128 can facilitate control of the pulse rate, volume, frequency and/or mode of operation of apparatus 100, therefore controlling waveform characteristics, Paragraph 0042); and an interface module (personal computer 202, Figure 7) in wireless communication with the communication module (apparatus 100 may be equipped with a wireless transceiver coupled to the microprocessor so that the acoustic generator 108 can be remotely programmed without the necessity for physical interconnection with the computer 202, Paragraph 0042), for providing instructions to the communication module thereby to control the communication module (personal computer 202 is used to provide instructions to microprocessor 128 to provide control parameters for a predefined series of acoustic waveforms to be generated by the transducer in an automated mode of operation of the acoustic generator 108, Paragraph 0040; microprocessor 128 can selectively control the volume, frequency, pulse, repetition rate of the acoustic vibrations, Paragraph 0034) and for adjusting at least one of: power, waveform intensity and waveform characteristics (personal computer 202 is used to provide instructions to microprocessor 128 to provide control parameters for a predefined series of acoustic waveforms to be generated by the transducer in an automated mode of operation of the acoustic generator 108, Paragraph 0040; microprocessor 128 can selectively control the volume, frequency, pulse, repetition rate of the acoustic vibrations, Paragraph 0034).
Although Hughes an interface module including a personal computer (computer 202, Figure 7) Hughes is silent on the interface module comprising a graphical user interface on a mobile device, the graphical user interface comprising virtual buttons.
However, Flickinger teaches a respiratory device (Abstract, Figure 1) comprising an interface module comprising a graphical user interface on a mobile device, the graphical user interface comprising virtual buttons (the portable nose irrigator may further comprise a communication device including a tablet or mobile device, therefore comprising virtual buttons, for analysis and storage in a database program, Paragraph 0009).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the device of Hughes by having the personal computer be a mobile device comprising a graphical user interface, as taught by Flickinger, as providing a mobile device rather than a personal computer may make the device more portable for the user, and provide a means of allowing the user to communicate with the device directly from his or her own personal mobile device.
Regarding clam 23, Hughes further discloses wherein the frequency generated by the OWG module varies between consecutive peaks of the wave (microprocessor 128 configured to selectively control the volume, frequency, pulse, and repetition rate of the acoustic vibrations generated by the acoustic generator 108, therefore fully capable of having varying frequencies between consecutive peaks, Paragraph 0034).
Regarding claim 25, Hughes further discloses wherein the oscillatory wave generator comprises a waveform generator for generating an electrical signal corresponding to the wave (acoustic generator 108 comprises a transducer 144, Paragraph 0037), and at least one of: an amplifier for increasing an amplitude and/or power of the electrical signal (acoustic generator 108 comprises audio amplifier circuitry, Paragraph 0037).
Regarding claim 26, Hughes further discloses wherein the oscillatory wave generator is adjustable to control output waveform characteristics (acoustic signal generator 108, Figure 6; produces a series of acoustic waveforms, Paragraph 0040, acoustic generator 108 comprises a programable microprocessor 128 can facilitate control of the pulse rate, volume, frequency and/or mode of operation of apparatus 100, Paragraph 0042).
Regarding claim 28, Hughes further teaches wherein the interface module is configured to instruct the communication module to adjust waveform characteristics of the wave (personal computer 202 is used to provide instructions to microprocessor 128 to provide control parameters for a predefined series of acoustic waveforms to be generated by the transducer in an automated mode of operation of the acoustic generator 108, Paragraph 0040; microprocessor 128 can selectively control the volume, frequency, pulse, repetition rate of the acoustic vibrations, Paragraph 0034).
Regarding claim 32, Hughes further discloses further comprising an acoustic window at a distal end of the housing (distal portion of mouthpiece 112 comprises an open end 116, Figure 3; through which the acoustic vibrations are delivered into patient’s airways, Paragraph 0045).
Claim(s) 24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hughes (US 2007/0113843 A1) in view of Santin et al. (US 2006/0085027 A1) and Foley et al. (US 9,730,830 B2).
Regarding claim 24, Hughes discloses a system for respiratory system secretion management (active respiratory therapeutic device for clearing breathing passages loosening and breaking up mucus plugs and phlegm in a patients sinuses, trachea, bronchial passages and lungs, Abstract), comprising: an external housing (external housing 102, Figures 6-8); an oscillatory wave generator (acoustic signal generator 108, Figure 6; produces a series of acoustic waveforms, Paragraph 0040), housed in the external housing (see acoustic signal generator 108 housed within external housing 102, Figure 6), for generating a wave for loosening secretion from a respiratory system of a subject (acoustic signal generator 108, Figure 6; produces a series of acoustic waveforms to loosening and breaking up mucus plugs in a patients sinuses, Paragraph 0040 and Abstract); an intranasal module in communication with the oscillatory wave generator (mouthpiece 300 may replace the mouthpiece 112 shown in Figure 1, the remainder of the apparatus 100 remains the same, mouthpiece 300 is inserted into a patient’s nostril rather than the patient’s mouth, Paragraph 0049 and Figures 9-10; acoustic vibrations pass though the acoustic coupling chamber 110 into the patient’s nose via mouthpiece, Paragraph 0012), for delivering the wave into a nasal passage of the subject (acoustic vibrations pass though the acoustic coupling chamber 110 into the patient’s nose or other delivery site via mouthpiece 300, Paragraph 0012); a power module configured to power the system (power supply is a rechargeable battery 142, Paragraph 0037); a communication module coupled to at least one of the intranasal module and the oscillatory wave generator (microprocessor 128, Paragraph 0037 and Figure 6, microprocessor is coupled to the mouthpiece via acoustic coupling chamber 110, Paragraph 0012), for selectively communicating power and/or one or more waveform characteristics to the respective intranasal module and/or oscillatory wave generator (microprocessor 128 can facilitate control of the pulse rate, volume, frequency and/or mode of operation of apparatus 100, therefore controlling waveform characteristics, Paragraph 0042); and an interface module (personal computer 202, Figure 7) in wireless communication with the communication module (apparatus 100 may be equipped with a wireless transceiver coupled to the microprocessor so that the acoustic generator 108 can be remotely programmed without the necessity for physical interconnection with the computer 202, Paragraph 0042), for providing instructions to the communication module, thereby to control the communication module (personal computer 202 is used to provide instructions to microprocessor 128 to provide control parameters for a predefined series of acoustic waveforms to be generated by the transducer in an automated mode of operation of the acoustic generator 108, Paragraph 0040; microprocessor 128 can selectively control the volume, frequency, pulse, repetition rate of the acoustic vibrations, Paragraph 0034), wherein the intranasal module is shaped to be positioned in the nasal passage (mouthpiece 300 may replace the mouthpiece 112 shown in Figure 1, mouthpiece 300 is inserted into a patient’s nostril rather than the patient’s mouth, Paragraph 0049 and Figures 9-10; mouthpiece 300 comprises tip section 308 adapted to interface with patient’s nasal tissues, Paragraph 0052), the intranasal module comprising: a housing shaped to seal against the nasal passage of the subject, through which the wave is delivered into the nasal passage (mouthpiece 300 comprises tip section 308, which is made from a soft flexible material intended to interface with the patient’s nasal tissues, Paragraph 0052 and Figures 9-10; acoustic vibrations pass though the acoustic coupling chamber 110 into the patient’s nose via mouthpiece, Paragraph 0012); wherein the intranasal module is in communication with the oscillatory wave generator via a waveguide (the acoustic signal generator 108 directs acoustic energy via a coupling chamber 110 and through a flexible tip section 308 of the mouthpiece 300 and into a patient’s airways via the mouthpiece, the flexible tip section being the waveguide, Figure 5 and Paragraph 0009), the external housing being connected to the intranasal module by the waveguide (the external housing 102 is connected to the mouthpiece 300 via the coupling chamber 110 and flexible tip section 308, Figure 8 and Paragraph 0043), the waveguide being flexible to permit flexible placement of the external housing during delivery of therapy (tip section 308 of mouthpiece 300, through which the acoustic waves are directed, is flexible, Paragraph 0050).
However, although Hughes teaches a device adapted to interface with the nasal tissues, Hughes doesn’t explicitly state wherein the intranasal module is adapted to grip the nasal passage, and is silent on an anchor component for preventing irretrievable slippage of the nasal module into the nasal passage of the subject.
In regards to the intranasal module being adapted to grip the nasal passage, Foley teaches a nasal insert (2, Figure 1 and Abstract) with an exterior surface that comprises a plurality of ribs (ribs 10, Figure 2) that allow the nasal tissue to settle in between the ridges/ribs, therefore gripping the nasal tissue (Column 6 lines 3-8).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the mouthpiece of Hughes device to be adapted to grip the nasal passages, through the use of ridges and ribs as taught by Foley, as this would help maintain the end of the mouthpiece in the nasal cavity while in use (Column 6 lines 3-8).
In regards to an anchor component for preventing irretrievable slippage of the nasal module into the nasal passage of the subject, Santin teaches a nasal insert (Figure 1 and Abstract) that comprises an anchor component to prevent slippage of the insert into the nasal passage (Tab support 20 comprising tabs 22, tabs 22 remain outside the user’s nostrils acting as a clip, to help secure the device in the nostrils and acts as a stop which prevent the device from being wholly inserted into the user’s nostril, Paragraph 0093 and Figure 5B).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the mouthpiece of Hughes device to include an anchor component in the form of a tab support comprising tabs in which clip to the user’s nostrils, as taught by Santin, as including such a feature would aid in securing the insert in the nasal passages of the subject while in use and prevent unwanted slippage/movement of the device with respect to the nasal cavities.
Regarding claim 27, Santin further teaches the anchor component comprises a hook for catching onto a columella of the subject (tab support 20 contains tabs 22, Figure 5B, which act as a clip, clipping and/or hooking to the nostril of user, Paragraph 0093). The Examiner notes the 112b rejection presented above for this particular claim.
Claim(s) 22 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Hughes (US 2007/0113843 A1) in view of Flickinger (US 2016/0339188 A1) and in further view of Dubey et al. (US 2017/0291007 A1).
Regarding claim 22, Hughes in view of Flickinger and Foley teach a system according to claim 21, and although Hughes teaches a system configured to generate varying frequencies (Paragraph 0035), Hughes doesn’t explicitly state wherein the OWG module, configured to generate a wave having a predetermined frequency of between 5 to 5,000 Hz.
However, Dubey teaches a therapeutic vibration system (Abstract) comprising a nasal tip (nasal tip 60, Figure 2 and Paragraph 0035) comprising an oscillating wave generator configured to generate waves having frequencies of between 5 to 5,000 Hz (the microprocessor configured to control the vibrations within a range of about 20 to 500 Hz, therefore within the claimed range, Paragraph 0036 and Figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hughes’s device by having the frequencies generated by in the range of 5 to 5,000 Hz, as taught by Dobey, as such frequencies are safe and effective frequencies capable of being used in direct contact with a user of the device.
Regarding claim 29, Hughes in view of Flickinger and Foley teach a system according to claim 21, wherein the interface module is configured to instruct the communication module (personal computer 202 is used to provide instructions to microprocessor 128 to provide control parameters for a predefined series of acoustic waveforms to be generated by the transducer in an automated mode of operation of the acoustic generator 108, Paragraph 0040), but is silent on the interface module instructing the communication module to toggle power to the system.
However, Dubey teaches a therapeutic vibration system in which an interface module (remote controller 212 has a user interface, Paragraph 0047) is configured to instruct the communication module (remote controller 212 has a wireless signal transmitter which may be used to send wireless signals to the vibrating patches, each having a wireless signal receiver 236, Paragraph 0055) to toggle power to the system (remote controller 212 may have a user interface including frequency control, turning the vibrating patches on and off, therefore toggling power, Paragraph 0047).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hughes device to have the interface module instruct the communications module to toggle power to the system, as taught by Dubey, as this would provide mobile power control to the system.
Regarding claim 30, Hughes in view of Flickinger teach a system according to claim 21, but is silent on a patch for attachment to facial skin the subject, the patch comprising at least one of the oscillatory wave generator, power module, and communication module.
However, Dubey teaches a therapeutic vibration system comprising a patch for facial attachment (vibrating patches 216 can be coupled to a person’s head above or below the eyes, Paragraph 0046 and Figure 21), with the patches further comprising an oscillatory wave generator (patches 216 include a vibrating motor 260, Paragraph 0047), power module (patches 216 include a battery 230, Paragraph 0047 and Figures 7 and 8B) and a communication module (patches 216 include a signal receiver 236, Paragraph 0047).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hughes device to include a patch for facial attachment, with the patch comprising at least one of the wave generator, power module, or communication module, as taught by Dubey, as this may provide a means of better securing the device to the facial region of the user while in use.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes (US 2007/0113843 A1) in view of Flickinger (US 2016/0339188 A1) and in further view of Jam (US 2014/0190481 A1).
Regarding claim 31, Hughes in view of Flickinger teach a system according to claim 21, however doesn’t explicitly state wherein the oscillatory wave generator generates a square wave.
However, Jam teaches an apparatus configured to generate various oscillations into a patient’s airways (Abstract) comprising an oscillatory wave generator (oscillator wave generator 71, Paragraph 0103 and Figure 6) configured to generate a square wave (wave generator 71 configured to generate square, sine, or triangle waves, Paragraph 0103 and Figure 6).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hughes device by having the wave generator generate square waves, as taught by Jam, as the use of square waves in an oscillating frequency device is well-known within the art and provide an effective means of generating acoustic vibrations introduced in a patient’s airways (Paragraph 0103 of Jam).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Davenport et al. (US 2016/0121062 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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