DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments made to claims 22-24, 27, 29, 30, 34, 40-42, 44, and 47, the cancellation of claims 25, 26, 28, and 31, and the addition of new claims 50 and 51 in the response filed 3/2/26 are acknowledged.
Claims 22-24, 27, 29, 30, and 32-51 are now pending in the application and are examined below.
Response to Arguments
Applicant's arguments filed 3/2/26 have been fully considered but they are not persuasive. Applicant argues on p. 11 that Danielian’s mouthguard is positioned on the maxilla, not the mandible. However, [0059] describes the device being worn on the upper and lower teeth at the same time. Applicant further argues on p. 11-12 that Danielian’s tongue depressor holds the tongue from obstructing the throat and is silent regarding a simple arced wire holding the tongue with end points near the anterior teeth of the mandible. However, Danielian discloses the wire 110 bending in an arced shape configured to extend behind a pharyngeal portion of a tongue of the subject (annotated fig. A, the wire 110 forms curves and arcs between the first and second ends; depending on the anatomy of the rear of the user’s mouth, the spine 110 is capable of extending behind a pharyngeal portion of a tongue of the subject, since the spine 110 extends rearwardly down the tongue), an arcuate portion of the wire 110 configured to be in contact with an entire width of a pharyngeal portion of a tongue of the subject to prevent the pharyngeal portion of the tongue of the subject from collapsing when the oropharynx appliance 100 is placed in the mouth of the subject (annotated fig. A shows the arcuate portion of the spine 110, which is the portion that extends across the rear of the retainer 102 and would be capable of contacting an entire width of the pharyngeal portion of the tongue depending on the position and shape/size of the user’s tongue; [0051], [0054], the spine 110 pushes down on the tongue and is thus capable of preventing the tongue from falling back into the pharynx to keep the airway open). Applicant argues on p. 12 that Danielian’s tongue depressor is attached to cross brackets with no resiliency, while the resilient device is claimed to return to a former shape when being pressed or pulled. However, Danielian discloses at least one of the first anchoring structure or the second anchoring structure comprises at least one resilient device that returns to its former shape when released after being pressed or pulled ([0053], body 102 (which includes its lingual walls, i.e. the anchoring structures) comprises layers 106 and 108 which are plastic material that become soft and pliable when warmed, making them resilient devices that are capable of returning to its former shape by being warmed and pressed into the desired shape), as claimed.
Applicant argues on p. 12-13 that, while Hadas teaches a sensor system, it is silent on the oropharynx device as described in claim 22. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Danielian already discloses the structural elements of the oropharynx appliance.
Applicant argues on p. 13-14 that, while McCreery teaches the wireless transceiver, it is silent on the oropharynx device as described in claim 22. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Danielian already discloses the structural elements of the oropharynx appliance.
Applicant argues on p. 15-16 that the rejection of claims 34 and 40 by Danielian, Hadas, and McCreery are in error for the same reasons as above for claim 22. However, the arguments regarding claim 22 have been unpersuasive, as discussed above.
Applicant argues on p. 16-19 regarding claims 41 and 44 that Hadas is silent on a non-invasive oropharynx appliance to physically at least partially prevent blockage of an oropharynx of the subject during sleep, because Hadas’ device fills a substantial portion of the oral cavity and would cause choking or difficulty swallowing. However, there is no evidence to support that Hadas’ device would necessarily cause choking or swallowing and thus be invasive. Further, the new amendments regarding the remote diagnostic device monitoring compliance has been addressed by new reference DuHamel. Applicant argues that, while McCreery teaches the wireless transceiver, it is silent on the oropharynx device and diagnostic device. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Hadas already discloses the structural elements of the oropharynx appliance, and DuHamel teaches the diagnostic device being configured to monitor compliance.
Claim Objections
Claims 22, 24, 34, 41, and 44 are objected to because of the following informalities:
“mouthguard the anterior” in claim 22, line 9 should be amended to recite --mouthguard and configured to be near the anterior--
“a pharyngeal portion of a tongue” in claim 22, line 17-18 should be amended to recite --the pharyngeal portion of the tongue--
“extends” in claim 24, line 2 should be amended to recite --is configured to extend--
“a subject” in claim 34, line 27 should be amended to recite --the subject--
“an oropharynx” in claim 41, line 8 should be amended to recite --the oropharynx--
“an oropharynx” in claim 44, line 8 should be amended to recite --the oropharynx--
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 22-24, 27, 29, 30, 32, 33, and 50 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 22, the claim positively recites “an anterior teeth region of the mandible” in line 7, and “the anterior teeth region of the mandible” in line 9, and “the anterior teeth region” in line 12. Language such as “configured” or “adapted” is suggested to avoid claiming a human organism.
Regarding claims 23, 24, 27, 29, 30, 32, 33, and 50, the claims are rejected under 35 U.S.C. 101 by virtue of their dependence on claim 22.
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: “diagnostic device” in claim 22, 34, 40, 41, 44; “engagement structure” in claim 29.
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. Please see [0050] for the diagnostic device, [0065] for the engagement structure.
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 § 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.
Claim(s) 22-24, 27, 29, 30, 32-40, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Danielian US 2013/0125902 A1 in view of Hadas US 2018/0125701 A1 further in view of McCreery US 8,249,723 B2.
Regarding claim 22, Danielian discloses a system 100 (fig. 1A and [0053], oral appliance 100) comprising:
an oropharynx appliance 100 configured to be placed within a mouth of a subject in a removable fashion (fig. 1A and 2C, and [0054], the device 100 comprises tongue depressor 112, which hangs downwards from the rear of the device and would thus be capable of affecting the oropharynx during use; [0053], the device 100 utilizes a body 102 that engages the user’s teeth as shown in fig. 1A, which would be capable of being removed), the oropharynx appliance 100 comprising:
a mouthguard 102 configured to removably fit over at least a portion of a mandible of the subject (fig. 1A and [0053], body 102 is formed to engage the user’s teeth and is made from moldable plastic, which is capable of acting as a mouthguard that prevents wearing down between the occlusal surfaces of the teeth and would be capable of removal from the teeth, as there are no permanent attachment features disclosed; [0067], the body 102 is worn on the upper and lower teeth);
a first anchoring structure attached to a first lingual side of the mouthguard 102 near an anterior teeth region of the mandible (please see annotated fig. A below, the first anchoring structure being the lingual wall at the rear of the base 102, which can be considered near or in the proximity of the anterior teeth region of the mandible);
a second anchoring structure attached to a second lingual side of the mouthguard 102 near the anterior teeth region of the mandible (annotated fig. A, the second anchoring structure being the opposite lingual wall at the rear of the base 102, which can be considered near or in the proximity of the anterior teeth region of the mandible); and
a wire 110 having a first end attached to the first anchoring structure and a second end attached to the second anchoring structure near the anterior teeth region (fig. 1B and [0055], the spine 110 is inserted into layer 104 of body 102 and thus attached to the first and second anchoring structures/lingual walls, as all portions of the device 100 are attached to each other; further, the spine 110 can be considered near or in the proximity of the anterior teeth region), wherein the wire 110 is configured to extend between the first end and the second end (please see annotated fig. A below, which shows the first and second ends of the metal spine 110, which are the points at which the spine 110 is inserted into the body of the retainer 102) and bends in an arced shape configured to extend behind a pharyngeal portion of a tongue of the subject (annotated fig. A, the wire 110 forms curves and arcs between the first and second ends; depending on the anatomy of the rear of the user’s mouth, the spine 110 is capable of extending behind a pharyngeal portion of a tongue of the subject, since the spine 110 extends rearwardly down the tongue), an arcuate portion of the wire 110 configured to be in contact with an entire width of a pharyngeal portion of a tongue of the subject to prevent the pharyngeal portion of the tongue of the subject from collapsing when the oropharynx appliance 100 is placed in the mouth of the subject (annotated fig. A shows the arcuate portion of the spine 110, which is the portion that extends across the rear of the retainer 102 and would be capable of contacting an entire width of the pharyngeal portion of the tongue depending on the position and shape/size of the user’s tongue; [0051], [0054], the spine 110 pushes down on the tongue and is thus capable of preventing the tongue from falling back into the pharynx to keep the airway open);
wherein at least one of the first anchoring structure or the second anchoring structure comprises at least one resilient device that returns to its former shape when released after being pressed or pulled ([0053], body 102 (which includes its lingual walls, i.e. the anchoring structures) comprises layers 106 and 108 which are plastic material that become soft and pliable when warmed, making them resilient devices that are capable of returning to its former shape by being warmed and pressed into the desired shape).
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Danielian is silent on a sensing system attached to a portion of the oropharynx appliance, the sensing system comprising: at least one sensor for detecting at least one property associated with obstructive sleep apnea (OSA) in the subject during sleep; and a transceiver to transmit data related to the at least one property associated with OSA to a remote diagnostic device.
However, Hadas teaches a system 10 for providing upper airway support (fig. 1A and [0049]) comprising a sensing system 230/209 attached to a portion of an analogous oropharynx apparatus 102/104/106/202 (fig. 1A and [0052], [0059], the device comprising a base member 102, a band 104, an enclosure 106, and support member 202; [0095], sensor arrangement 230; [0101], communication unit 209; fig. 6, enclosure 106 houses the sensor arrangement 230 and the communication unit 209), the sensing system 230/209 comprising: at least one sensor 230 for detecting at least one property associated with obstructive sleep apnea (OSA) in the subject during sleep ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.; respiration status and blood oxygenation are associated with OSA); and a transceiver 209 to transmit data related to the at least one property associated with OSA to a remote diagnostic device 300 (fig. 6 and [0101], communication unit 209 within enclosure 106 can transmit sensor data to bedside unit 300, which is processed by processor 305 for analysis; [0098], device 10 is removable from bedside unit 300).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the system of Danielian with a sensing system attached to a portion of the oropharynx appliance, the sensing system comprising: at least one sensor for detecting at least one property associated with obstructive sleep apnea (OSA) in the subject during sleep; and a transceiver to transmit data related to the at least one property associated with OSA to a remote diagnostic device, as taught by Hadas, to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Danielian in view of Hadas is silent on the transceiver being a wireless transceiver.
However, McCreery teaches an oral device 302 comprising a sensing system 301 (fig. 3 and col. 9, lines 55-58), wherein the sensing system 301 comprises a transceiver that is a wireless transceiver (fig. 2 and col. 8, lines 49-62, sensor communicates with controller via wireless signals so that the controller can translate the signals from the sensor; thus, the sensor must have some kind of wireless transceiver as part of its system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transceiver of Danielian in view of Hadas to be a wireless transceiver, as taught by McCreery, to eliminate undesirable, excess wiring to make the device more comfortable and convenient for the user.
Regarding claim 23, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Danielian further discloses the first end and the second end being configured to be positioned on opposing sides of the mandible of the subject ([0067], body 102 is fitted to the lower and upper teeth, and as can be seen in annotated fig. A, the end points are positioned on opposing sides of the body 102; therefore, when worn, the end points would be positioned on opposing sides of the mandible and maxilla).
Regarding claim 24, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Danielian further discloses a portion of the wire 110 extending in a plane parallel to the mandible (fig. 1A, spine 110 extends across the body 102 laterally and thus extends in a plane parallel to the mandible, which extends laterally in the mouth, when worn).
Regarding claim 27, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Danielian further discloses the first anchoring structure and the second anchoring structures being each configured to prevent movement of the wire 110 under a weight of the tongue but configured to allow movement of the wire 110 during swallowing ([0056], [0057], and [0060] describe ways to manipulate and adjust the spine 110 to achieve the position desired; thus, a specific position could be achieved via manipulation that would prevent movement of the spine 110 under the weight of the tongue but allows movement during swallowing).
Regarding claim 29, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Danielian further discloses an engagement structure 112 that is connected to, or integrally formed with, the arcuate portion of the wire 110 (fig. 1A and [0054], tongue depressor 112 is attached to the central/arcuate portion of the spine 110).
Regarding claim 30, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Danielian further discloses the engagement structure 112 having a cross-sectional area greater than a cross-sectional area of the wire 110 (fig. 1A, the cross-sectional area of the tongue depressor 112 in the horizontal plane is greater than the spine 110, which is just a wire).
Regarding claim 32, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Hadas further teaches the at least one property associated with OSA being air flow through the oropharynx, oxygen saturation of the subject ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.), temperature, cardiac electrical signals, sound, and/or a position of the pharyngeal portion of the tongue, to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Regarding claim 33, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Hadas further teaches the at least one property associated with OSA being oxygen saturation of the subject ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.), to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Regarding claim 34, Danielian discloses a method (fig. 1A and [0053], oral appliance 100; [0019], the invention comprises the method for using the invention) comprising:
placing, in a removable fashion, an oropharynx appliance 100 in a mouth of a subject (fig. 1A and 2C, and [0054], the device 100 comprises tongue depressor 112, which hangs downwards from the rear of the device and would thus affect the oropharynx during use; [0051], the tongue depressor keeps the airway open to allow the patient to breathe, which would require the device 100 to be within the mouth of the subject; [0053], the device 100 utilizes a body 102 that engages the user’s teeth as shown in fig. 1A, which would be capable of being removed), the oropharynx appliance 100 comprising:
a mouthguard 102 configured to removably fit over at least a portion of a mandible of the subject (fig. 1A and [0053], body 102 is formed to engage the user’s teeth and is made from moldable plastic, which is capable of acting as a mouthguard that prevents wearing down between the occlusal surfaces of the teeth and would be capable of removal from the teeth, as there are no permanent attachment features disclosed; [0067], the body 102 is worn on the upper and lower teeth);
a first anchoring structure attached to a first lingual side of the mouthguard 102 near an anterior teeth region of the mandible (please see annotated fig. A, the first anchoring structure being the lingual wall at the rear of the base 102, which can be considered near or in the proximity of the anterior teeth region of the mandible);
a second anchoring structure attached to a second lingual side of the mouthguard 102 near the anterior teeth region of the mandible (annotated fig. A, the second anchoring structure being the opposite lingual wall at the rear of the base 102, which can be considered near or in the proximity of the anterior teeth region of the mandible); and
a wire 110 having a first end attached to the first anchoring structure and a second end attached to the second anchoring structure near the anterior teeth region (fig. 1B and [0055], the spine 110 is inserted into layer 104 of body 102 and thus attached to the first and second anchoring structures/lingual walls, as all portions of the device 100 are attached to each other; further, the spine 110 can be considered near or in the proximity of the anterior teeth region), wherein the wire 110 is configured to extend at least partially along a lingual surface between the first end and the second end (please see annotated fig. A, which shows the first and second ends of the metal spine 110, which are the points at which the spine 110 is inserted into the body of the retainer 102; as seen in fig. 1A of annotated fig. A, the spine 110 extends across the retainer 102 such that it would extend across the tongue surface during use) and bend in an arced shape configured to extend behind a pharyngeal portion of a tongue of the subject (annotated fig. A, the wire 110 forms curves and arcs between the first and second ends; depending on the anatomy of the rear of the user’s mouth, the spine 110 is capable of extending behind a pharyngeal portion of a tongue of the subject, since the spine 110 extends rearwardly down the tongue), an arcuate portion of the wire 110 configured to be in contact with an entire width of the pharyngeal portion of the tongue of the subject to prevent the pharyngeal portion of the tongue of the subject from collapsing (annotated fig. A shows the arcuate portion of the spine 110, which is the portion that extends across the rear of the retainer 102 and would be capable of contacting an entire width of the pharyngeal portion of the tongue depending on the position and shape/size of the user’s tongue; [0051], [0054], the spine 110 pushes down on the tongue and is thus capable of preventing the tongue from falling back into the pharynx to keep the airway open);
wherein at least one of the first anchoring structure or the second anchoring structure comprises at least one resilient device that returns to its former shape when released after being pressed or pulled ([0053], body 102 (which includes its lingual walls, i.e. the anchoring structures) comprises layers 106 and 108 which are plastic material that become soft and pliable when warmed, making them resilient devices that are capable of returning to its former shape by being warmed and pressed into the desired shape).
Danielian is silent on a sensing system attached to a portion of the oropharynx appliance; measuring, by a sensor of the sensing system, at least one property associated with obstructive sleep apnea (OSA) in a subject during sleep, transmitting, by a transceiver of the sensing system, data related to the at least one property to an external diagnostic device; and determining, by the external diagnostic device, a degree of obstruction of an oropharynx of the subject at one or more times during sleep based on the transmitted data.
However, Hadas teaches a system 10 for providing upper airway support (fig. 1A and [0049]) comprising a sensing system 230/209 attached to a portion of an analogous oropharynx apparatus 102/104/106/202 (fig. 1A and [0052], [0059], the device comprising a base member 102, a band 104, an enclosure 106, and support member 202; [0095], sensor arrangement 230; [0101], communication unit 209; fig. 6, enclosure 106 houses the sensor arrangement 230 and the communication unit 209), measuring, by a sensor 230 of a sensing system 230/209, at least one property associated with obstructive sleep apnea (OSA) in a subject during sleep (fig. 1A and [0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.; respiration status and blood oxygenation provides information about the position of the tongue and whether it is obstructing the oropharynx, since respiration and blood oxygenation would reduce with tongue obstruction; [0106], sensor arrangement 230 sends signals to the control unit 204 indicating respiratory events such as apneas; [0003], apneic events occur when the tongue and other soft tissue affect the flow of air; therefore, the sensor signals indicate the position of the tongue (obstructing or non-obstructing)); transmitting, by a transceiver of the sensing system 230/209, data related to the at least one property to an external diagnostic device 300 (fig. 6 and [0101], communication unit 209 within enclosure 106 can transmit sensor data to bedside unit 300, which is processed by processor 305 for analysis; [0098], device 10 is removable from bedside unit 300); and determining, by the external diagnostic device 300, a degree of obstruction of an oropharynx of the subject at one or more times during sleep based on the transmitted data ([0106], control unit 204 analyzes received signals from sensor 230 to determine apneic events (indicative of obstruction of oropharynx); [0101], control unit 304 of bedside unit 300 communicates with communication unit 209 to actuate the helical spring 202).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the method of Danielian with a sensing system attached to a portion of the oropharynx appliance; measuring, by a sensor of a sensing system, at least one property associated with obstructive sleep apnea (OSA) in a subject during sleep, transmitting, by a transceiver of the sensing system, data related to the at least one property to an external diagnostic device; and determining, by the external diagnostic device, a degree of obstruction of an oropharynx of the subject at one or more times during sleep based on the transmitted data, as taught by Hadas, to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Danielian in view of Hadas is silent on the transceiver being a wireless transceiver.
However, McCreery teaches an oral device 302 comprising a sensing system 301 (fig. 3 and col. 9, lines 55-58), wherein the sensing system 301 comprises a transceiver that is a wireless transceiver (fig. 2 and col. 8, lines 49-62, sensor communicates with controller via wireless signals so that the controller can translate the signals from the sensor; thus, the sensor must have some kind of wireless transceiver as part of its system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transceiver of Danielian in view of Hadas to be a wireless transceiver, as taught by McCreery, to eliminate undesirable, excess wiring to make the device more comfortable and convenient for the user.
Regarding claim 35, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Hadas further teaches placing the oropharynx apparatus 10 into a mouth of the subject before sleep ([0104], the user secures the device 10 in the mouth and then falls asleep) such that the oropharynx apparatus 10 is fitted tightly within the mouth ([0053], base member 102 is molded to the teeth and uses anchoring mechanisms such as vacuum based tight fitting acrylic dental impression molds), to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Regarding claim 36, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Hadas further teaches constructing the oropharynx appliance 10 to prevent or treat OSA based on the transmitted data ([0106], the helical spring 202 is driven based on the sensors’ signals; therefore, the spring deployment plan of the device is constructed based on the transmitted data from the sensor), to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Regarding claim 37, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Hadas further teaches the at least one property associated with OSA being air flow through the oropharynx, oxygen saturation of the subject ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.), temperature, cardiac electrical signals, sound, and/or a position of the pharyngeal portion of the tongue, to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Regarding claim 38, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Hadas further teaches the transmitted data corresponding to oxygen saturation of the subject ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.; [0101], communication unit 209 within enclosure 106 can transmit sensor data to bedside unit 300, which is processed by processor 305 for analysis), to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Regarding claim 39, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Hadas further teaches treating the subject for OSA based on the determined degree of obstruction ([0106], control unit 204 analyzes received signals from sensor 230 to determine apneic events (indicative of degree of obstruction of oropharynx); [0101], control unit 304 of bedside unit 300 communicates with communication unit 209 to actuate the helical spring 202, which treats OSA by reducing obstruction), to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Regarding claim 40, Danielian discloses a system 100 (fig. 1A and [0053], oral appliance 100) comprising:
an oropharynx appliance 100 (fig. 1A and 2C, and [0054], the device 100 comprises tongue depressor 112, which hangs downwards from the rear of the device and would thus be capable of affecting the oropharynx during use) comprising:
a mouthguard 102 configured to removably fit over at least a portion of a mandible of the subject (fig. 1A and [0053], body 102 is formed to engage the user’s teeth and is made from moldable plastic, which is capable of acting as a mouthguard that prevents wearing down between the occlusal surfaces of the teeth and would be capable of removal from the teeth, as there are no permanent attachment features disclosed; [0067], the body 102 is worn on the lower teeth);
a wire 110 having a first end and a second end, with a length extending therebetween that is configured to bend in an arced shape (and [0055], spine 110; annotated fig. B, which shows a length of the wire 110 extending between first and second ends, which are the points at which the spine 110 is inserted into the body of the retainer 102; the wire 110 forms curves and arcs between the first and second ends; depending on the anatomy of the rear of the user’s mouth, the spine 110 is capable of extending behind a pharyngeal portion of a tongue of the subject, since the spine 110 extends rearwardly down the tongue), wherein an arcuate portion of the wire 110 is sized and dimensioned to extend across and contact an entire width of a pharyngeal portion of a tongue of the subject to prevent the pharyngeal portion of the tongue of the subject from collapsing when the oropharynx appliance 100 is placed in the mouth of the subject (annotated fig. B shows the arcuate portion of the spine 110, which is the portion that extends across the rear of the retainer 102 and would be capable of contacting an entire width of the pharyngeal portion of the tongue depending on the position and shape/size of the user’s tongue; [0051], [0054], the spine 110 pushes down on the tongue and is thus capable of preventing the tongue from falling back into the pharynx to keep the airway open); and
bilateral anchoring structures 104/106 that are connected to the first end and the second end of the wire 110 and are configured to secure the wire 110 to first and second anchor points of the mouthguard, respectively, proximal to the mandible (annotated fig. B, the left and right halves of body 102 comprising layers 104/106 (excluding layer 108) being the bilateral anchoring structures, such that the first/left end point of spine 110 connects to the first/left half of body 102 at the first anchor point of body 102 where the first/left end point inserts into body 102, and the second/right end point of spine 110 connects to the second/right half of body 102 at the second anchor point of body 102 where the second/right end point inserts into body 102; [0067], body 102 is fitted to the lower and upper teeth, and as can be seen in annotated fig. B, the end points and corresponding anchor points are positioned on opposing sides of the body 102; therefore, when worn, the anchor points would be positioned proximal to and on opposing sides of the mandible and maxilla), wherein each of the bilateral anchoring structures 104/106 comprises at least one resilient device 106 that returns to its former shape when released after being pressed or pulled ([0053], layer 106 is plastic material that becomes soft and pliable when warmed, making the left and right halves of layer 106 resilient devices that are capable of returning to its former shape by being warmed after releasing from the teeth, and pressed into the desired shape), wherein the bilateral anchoring structures 104/106 are configured to be proximal to one or more of the subject’s lower incisive teeth when the oropharynx appliance 100 is placed in the mouth of the subject ([0067], body 102 is fitted to the lower and upper teeth; thus, when worn, each half/bilateral anchoring structure 104/106 of body 102 is proximal/near the lower incisive teeth).
Danielian is silent on a sensing system attached to a portion of the oropharynx appliance, the sensing system comprising: an oxygen sensor for detecting oxygen saturation in an oropharynx of the subject; and a transceiver to transmit data related to the oxygen saturation in the oropharynx to a remote diagnostic device.
However, Hadas teaches a system 10 for providing upper airway support (fig. 1A and [0049]) comprising a sensing system 230/209 attached to a portion of an analogous oropharynx apparatus 102/104/106/202 (fig. 1A and [0052], [0059], the device comprising a base member 102, a band 104, an enclosure 106, and support member 202; [0095], sensor arrangement 230; [0101], communication unit 209; fig. 6, enclosure 106 houses the sensor arrangement 230 and the communication unit 209), the sensing system 230/209 comprising: an oxygen sensor for detecting oxygen saturation in an oropharynx of the subject ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.; respiration status and blood oxygenation are associated with OSA); and a transceiver 209 to transmit data related to the oxygen saturation in the oropharynx to a remote diagnostic device 300 (fig. 6 and [0101], communication unit 209 within enclosure 106 can transmit sensor data to bedside unit 300, which is processed by processor 305 for analysis; [0098], device 10 is removable from bedside unit 300).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the system of Danielian with a sensing system attached to a portion of the oropharynx appliance, the sensing system comprising: an oxygen sensor for detecting oxygen saturation in an oropharynx of the subject; and a transceiver to transmit data related to the oxygen saturation in the oropharynx to a remote diagnostic device, as taught by Hadas, to allow sensed data to inform the position of the tongue supporting member ([0024]) for a more effective device.
Danielian in view of Hadas is silent on the transceiver being a wireless transceiver.
However, McCreery teaches an oral device 302 comprising a sensing system 301 (fig. 3 and col. 9, lines 55-58), wherein the sensing system 301 comprises a transceiver that is a wireless transceiver (fig. 2 and col. 8, lines 49-62, sensor communicates with controller via wireless signals so that the controller can translate the signals from the sensor; thus, the sensor must have some kind of wireless transceiver as part of its system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transceiver of Danielian in view of Hadas to be a wireless transceiver, as taught by McCreery, to eliminate undesirable, excess wiring to make the device more comfortable and convenient for the user.
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Regarding claim 50, Danielian in view of Hadas further in view of McCreery discloses the claimed invention as discussed above.
Danielian further discloses the wire 110 comprising a metal ([0054], metal spine 110), an organic material, and or a polymer.
Claim(s) 41-49 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadas US 2018/0125701 A1 in view of McCreery US 8,249,723 B2 further in view of DuHamel et al. US 2010/0152599 A1.
Regarding claim 41, Hadas discloses a system 10 (fig. 1A and [0052]) comprising:
a non-invasive oropharynx appliance 102/104/106/202 configured to be placed within a mouth of a subject in a removable fashion (fig. 1A and [0052], [0059], the device comprising a base member 102, a band 104, an enclosure 106, and support member 202; since base member 102 is a retainer that secures to teeth of the user, it is non-invasive and removable) to physically at least partially prevent blockage of an oropharynx of the subject during sleep (figs. 1B and C and [0064], the distal end 202a of support member 202 contacts regions of tissue in the oral cavity or upper airway to prevent collapse of the airway); and
a sensor system 230/209 attached to a portion of the oropharynx apparatus 102/104/106/202 (fig. 6, enclosure 106 houses the sensor arrangement 230 and the communication unit 209), the sensor system 230/209 comprising:
at least one sensor 230 for detecting at least one property associated with obstruction of an oropharynx of the subject by a tongue of the subject during sleep ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.; respiration status and blood oxygenation can provide information about the position of the tongue and whether it is obstructing the oropharynx, since respiration and blood oxygenation would reduce with tongue obstruction); and
a transceiver 209 to transmit data related to the at least one property to a remote diagnostic device 300 (fig. 6 and [0101], communication unit 209 within enclosure 106 can transmit sensor data to bedside unit 300, which is processed by processor 305 for analysis; [0098], device 10 is removable from bedside unit 300).
Hadas is silent on the transceiver being a wireless transceiver.
However, McCreery teaches an oral device 302 comprising a sensing system 301 (fig. 3 and col. 9, lines 55-58), wherein the sensing system 301 comprises a transceiver that is a wireless transceiver (fig. 2 and col. 8, lines 49-62, sensor communicates with controller via wireless signals so that the controller can translate the signals from the sensor; thus, the sensor must have some kind of wireless transceiver as part of its system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transceiver of Hadas to be a wireless transceiver, as taught by McCreery, to eliminate undesirable, excess wiring to make the device more comfortable and convenient for the user.
Hadas in view of McCreery is silent on the remote diagnostic device configured to monitor a compliance of the subject wearing the oropharynx appliance and/or diagnosing obstructive sleep apnea (OSA) of the subject.
However, DuHamel teaches an analogous oral appliance 101 (fig. 1 and [0026]) comprising a remote diagnostic device configured to monitor a compliance of the subject wearing the appliance 101 (fig. 1 and [0027]-[0037], sensor chips 102 on the oral appliance measure a variety of physiological signals and sends the information to software on a computer (i.e., the remote diagnostic device), which reports hours of wearing the appliance and noncompliance patients) and/or diagnosing obstructive sleep apnea (OSA) of the subject.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have configured the remote diagnostic device of Hadas in view of McCreery to monitor a compliance of the subject wearing the oropharynx appliance and/or diagnosing obstructive sleep apnea (OSA) of the subject, as taught by DuHamel, to ensure patients successfully complete their treatment protocol.
Regarding claim 42, Hadas in view of McCreery further in view of DuHamel discloses the claimed invention as discussed above.
Hadas further discloses the at least one property associated with obstruction of the oropharynx being air flow through the oropharynx, oxygen saturation of the subject ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.), temperature, cardiac electrical signals, sound, and/or a position of the pharyngeal portion of the tongue.
Regarding claim 43, Hadas in view of McCreery further in view of DuHamel discloses the claimed invention as discussed above.
Hadas further discloses the at least one property associated with obstruction of the oropharynx being oxygen saturation of the subject ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.).
Regarding claim 44, Hadas discloses a method (fig. 1A and [0106], the device 10 may be used in apnea mode to respond to respiratory events) comprising:
placing, in a removable fashion, an oropharynx appliance 10 in a mouth of a subject ([0104], the user secures the device 10 in the mouth and then falls asleep; [0052] and fig. 1A, base member 102 is a retainer that secures to teeth, making it removable), the oropharynx appliance 10 configured to physically at least partially prevent blockage of an oropharynx of the subject during sleep (figs. 1B and C and [0064], the distal end 202a of support member 202 contacts regions of tissue in the oral cavity or upper airway to prevent collapse of the airway) and including
a sensor system 230/209 attached to a portion of the oropharynx appliance 102/104/106/202 (fig. 1A and [0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.; respiration status and blood oxygenation; fig. 6 and [0101], communication unit 209 within enclosure 106), the sensor system 230/209 comprising:
at least one sensor 230 for detecting at least one property associated with obstruction of an oropharynx of the subject during sleep ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.; respiration status and blood oxygenation can provide information about the position of the tongue and whether it is obstructing the oropharynx, since respiration and blood oxygenation would reduce with tongue obstruction); and
a transceiver 209 to transmit data related to the at least one property to a remote diagnostic device 300 (fig. 6 and [0101], communication unit 209 within enclosure 106 can transmit sensor data to bedside unit 300, which is processed by processor 305 for analysis; [0098], device 10 is removable from bedside unit 300);
measuring, by the at least one sensor 230, the at least one property associated with obstruction of the oropharynx in the subject during sleep (fig. 1A and [0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.; respiration status and blood oxygenation provides information about the position of the tongue and whether it is obstructing the oropharynx, since respiration and blood oxygenation would reduce with tongue obstruction; [0106], sensor arrangement 230 sends signals to the control unit 204 indicating respiratory events such as apneas; [0003], apneic events occur when the tongue and other soft tissue affect the flow of air; therefore, the sensor signals indicate the position of the tongue (obstructing or non-obstructing));
transmitting, by the transceiver of the sensor system 230/209, data related to the at least one property to the remote diagnostic device 300 (fig. 6 and [0101], communication unit 209 within enclosure 106 can transmit sensor data to bedside unit 300, which is processed by processor 305 for analysis; [0098], device 10 is removable from bedside unit 300);
determining, by the remote diagnostic device 300, a degree of obstruction of the oropharynx of the subject at one or more times during sleep based on the transmitted data ([0106], control unit 204 analyzes received signals from sensor 230 to determine snoring, hypopneas or apneas (indicative of degree of obstruction of oropharynx); [0101], control unit 304 of bedside unit 300 communicates with communication unit 209 to actuate the helical spring 202).
Hadas is silent on the transceiver being a wireless transceiver.
However, McCreery teaches an oral device 302 comprising a sensing system 301 (fig. 3 and col. 9, lines 55-58), wherein the sensing system 301 comprises a transceiver that is a wireless transceiver (fig. 2 and col. 8, lines 49-62, sensor communicates with controller via wireless signals so that the controller can translate the signals from the sensor; thus, the sensor must have some kind of wireless transceiver as part of its system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transceiver of Hadas to be a wireless transceiver, as taught by McCreery, to eliminate undesirable, excess wiring to make the device more comfortable and convenient for the user.
Hadas in view of McCreery is silent on determining, by the remote diagnostic device a compliance of the subject wearing the oropharynx appliance and/or diagnosing obstructive sleep apnea (OSA) of the subject.
However, DuHamel teaches an analogous oral appliance 101 (fig. 1 and [0026]), and determining by a remote diagnostic device a compliance of the subject wearing the appliance 101 (fig. 1 and [0027]-[0037], sensor chips 102 on the oral appliance measure a variety of physiological signals and sends the information to software on a computer (i.e., the remote diagnostic device), which reports hours of wearing the appliance and noncompliance patients) and/or diagnosing obstructive sleep apnea (OSA) of the subject.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the method of Hadas in view of McCreery with determining, by the remote diagnostic device a compliance of the subject wearing the oropharynx appliance and/or diagnosing obstructive sleep apnea (OSA) of the subject, as taught by DuHamel, to ensure patients successfully complete their treatment protocol.
Regarding claim 45, Hadas in view of McCreery further in view of DuHamel discloses the claimed invention as discussed above.
Hadas further discloses placing the oropharynx appliance 10 into the mouth of the subject before sleep ([0104], the user secures the device 10 in the mouth and then falls asleep) such that the oropharynx appliance 10 is fitted tightly within the mouth ([0053], base member 102 is molded to the teeth and uses anchoring mechanisms such as vacuum based tight fitting acrylic dental impression molds).
Regarding claim 46, Hadas in view of McCreery further in view of DuHamel discloses the claimed invention as discussed above.
Hadas further discloses constructing the oropharynx appliance 10 to prevent or treat OSA or snoring based on the transmitted data ([0106], the helical spring 202 is driven based on the sensors’ signals; therefore, the spring deployment plan of the device is constructed based on the transmitted data from the sensor, and the spring prevents the tongue from obstructing the pharynx).
Regarding claim 47, Hadas in view of McCreery further in view of DuHamel discloses the claimed invention as discussed above.
Hadas further discloses the at least one property associated with obstruction of the pharynx being air flow through the oropharynx, oxygen saturation of the subject ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.), temperature, cardiac electrical signals, sound, and/or a position of a pharyngeal portion of the tongue.
Regarding claim 48, Hadas in view of McCreery further in view of DuHamel discloses the claimed invention as discussed above.
Hadas further discloses the transmitted data corresponding to oxygen saturation of the subject ([0095], sensor arrangement 230 may comprise a variety of sensors housed within enclosure 106 to provide physiological data such as respiration status, blood oxygenation, etc.; [0101], communication unit 209 within enclosure 106 can transmit sensor data to bedside unit 300, which is processed by processor 305 for analysis).
Regarding claim 49, Hadas in view of McCreery further in view of DuHamel discloses the claimed invention as discussed above.
Hadas further discloses treating the subject for OSA or snoring based on the determined degree of obstruction ([0106], control unit 204 analyzes received signals from sensor 230 to determine apneic events (indicative of degree of obstruction of oropharynx); [0101], control unit 304 of bedside unit 300 communicates with communication unit 209 to actuate the helical spring 202, which treats OSA by reducing obstruction).
Regarding claim 51, Hadas in view of McCreery further in view of DuHamel discloses the claimed invention as discussed above.
Hadas further discloses the at least one sensor 230/209 being an oxygen saturation sensor configured to measure an amount of oxygen the subject receives at a given time ([0023], the sensors may include an oxygen saturation sensor).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786
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