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 Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quaka et al. U.S. Patent No. (10,085,877 B2).
With respect to claim 1, Quaka et al. discloses an oral appliance for treating sleep apnea in a user (abstract) and (figs.1-5), comprising:
a first appliance frame (2, fig.1) adapted to engage one or more upper teeth of a user when worn ([Col.6], lines 51-64), the first appliance frame (2) including an anterior side (where element 5 is located in fig.1) and a posterior side defining a first appliance longitudinal axis or vertical axis;
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a second appliance frame (3, fig.1) adapted to engage one or more lower teeth of the user when worn ([Col.7], lines 7-10);
a first connector (9, 10 fig.1) coupled to the first appliance frame (2) and a second connector (12, 13, fig.1) coupled to the second appliance frame (3);
wherein the first (9,10) and second (12,13) connectors are engageable with one another to restrict movement of the second appliance frame relative to the first appliance frame in a direction generally parallel to the first appliance longitudinal axis (as shown in fig.2) while enabling movement of the second appliance frame ([Col.5], lines 34-36, the devices are worn while sleeping, to support the lower jaw in a more forwardly position, as may be prescribed by the dentist or doctor specializing in throat disorders); ([Col.5, lines 58-63, the present disclosure also provides upper and lower trays for a sleep apnea device, that are applied to the teeth and which incorporate a biasing device, which may be adjusted to furnish a resetting in the miniscule to more advanced forward movement to the mandibular or lower jaw, of the patient, during wearing of this device) and of the first appliance frame (2) in a direction generally perpendicular to the first appliance longitudinal axis [(Col.7], lines 14-30, Thus, when the appliance 1 is in place and the maxillary portion of the user's jaw locates within tray 2, and the mandibular set of teeth of the user locate within the downwardly disposed trough of tray 3, the upper and lower trays, as at 2 and 3, are generally in alignment with each other, such that when the expansion screws 8 are adjusted, in a manner as known in the trade, it forces the boss members 9 and 10 forwardly, against the aligned surface of the upright structures 12 and 13, as can be readily seen within these figures. Thus, when the expansion screws 8 are expanded, it forces the bottom tray 3 to be advanced somewhat forwardly relative to the tray 2, generally as noted by the displacement shown at 14, such that the lower jaw advances at least to that dimension and does have a tendency to further open the air passage of the user, with a tendency to reduce the effects of snoring or apnea, particularly while sleeping]; as such, when the lower tray or second appliance frame move forward while the upper tray or the first appliance tray remain stationary, the first appliance frame or upper tray will be in a direction generally perpendicular to the first appliance or upper tray longitudinal axis; Note: the purpose of the invention is to open the air passage of the user, with a tendency to reduce the effects of snoring or apnea, particularly while sleeping, and since the second frame appliance is restricted to move forwardly and not backward when the expansion screws 8 are expanded, it forces the bottom tray 3 to be advanced somewhat forwardly relative to the tray 2; while the oral appliance is worn by the user ([Col.4, lines 34-47, the device is customized for each patient, in accordance with the device and through the usage of its expansion devices, generally screw type of adjustment, enables the mandibular to attain an amount of advancement, generally to be set by the dentist or physician, at the time of its initial fitting, or when readjustment may be required. The prescribing dentist can determine the exact repositioning of the lower bite, or mandibular tray, relative to the wax construction bite obtained from the patient through the operations of the clinician initially forming the device. The dentist may also be able to fine-tune the jaw positioning expansion means, clinically, as needed by altering the screw and/or adjusting the acrylic portions of the appliance, for precise settings]. Note: “while being worn” is being interpreted as, when the oral appliance is initially fitted in the mouth, it is generally considered being worn at that moment, as it is in position and covering the teeth, during the fitting process as described in ([Col.4], lines 34-47).
With respect to claim 2, Quaka et al. discloses the first (9,10) and second (12,13) connectors are engageable with one another to restrict movement of the second appliance frame relative to the first appliance frame in a direction generally parallel to the first appliance longitudinal axis [(Col.7], lines 14-30, Thus, when the appliance 1 is in place and the maxillary portion of the user's jaw locates within tray 2, and the mandibular set of teeth of the user locate within the downwardly disposed trough of tray 3, the upper and lower trays, as at 2 and 3, are generally in alignment with each other, such that when the expansion screws 8 are adjusted, in a manner as known in the trade, it forces the boss members 9 and 10 forwardly, against the aligned surface of the upright structures 12 and 13, as can be readily seen within these figures. Thus, when the expansion screws 8 are expanded, it forces the bottom tray 3 to be advanced somewhat forwardly relative to the tray 2, generally as noted by the displacement shown at 14, such that the lower jaw advances at least to that dimension and does have a tendency to further open the air passage of the user, with a tendency to reduce the effects of snoring or apnea, particularly while sleeping]; Note: the purpose of the invention is to open the air passage of the user, with a tendency to reduce the effects of snoring or apnea, particularly while sleeping, and since the second frame appliance is restricted to move forwardly and not backward when the expansion screws 8 are expanded, it forces the bottom tray 3 to be advanced somewhat forwardly relative to the tray 2, towards the posterior side of the first appliance frame via (9,10) which are located toward the posterior side of the first appliance frame.
With respect to claim 3, Quaka et al. discloses the first connector (9, 10 fig.1) includes a gap (as shown in the reproduced image of fig.1 below) adapted to receive at least a portion of the second connector (11-12, as shown in fig.2).
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With respect to claim 4, Quaka et al. discloses the second connector (11-12) includes a gap (as shown in the reproduced image of fig.1 below) adapted to receive at least a portion of the first connector (9, 10, as shown in fig.2).
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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) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Quaka et al. as applied to claim 1 above, and further in view of Liptak et al. U.S. Patent No. (9,820,882 B2).
With respect to claim 5, Quaka et al. substantially discloses the invention as claimed except the second connector extends over at least a portion of the first frame.
Liptak et al., however, teaches a mandibular advancement devices (figs.1A-3B) comprising an upper splint and a lower splint, where the upper splint comprises one or more upper fins, where each upper fin is located at a distance UD from back of the upper splint; the lower splints comprise one or more lower fins (abstract) for treating sleep apnea and snoring ([Col.1], lines 22-26), wherein the upper splint or first appliance frame (102) comprises first connectors (114, 114, fig.2B) and lower splint or second appliance frame (104) comprises second connectors (116, 116, fig.2A); wherein the second connectors (116, 116) extends over at least a portion of the first frame or upper splint (as shown in fig.3A).
In view of the teachings of Liptak et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the second connector of Quaka et al. incorporating a second connector that extends over at least a portion of the first frame such that when the splint is worn by the patient, the fin is near the molars ([Col.5], lines 16-19) of Liptak et al.
With respect to claim 6, the combination of Quaka et al./Liptak et al. substantially discloses the invention as claimed. Liptak et al. further teaches the first connector (114) extends over at least a portion of the second frame (as shown in fig.3B).
In view of the teachings of Liptak et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first connector of Quaka et al. incorporating a first connector that extends over at least a portion of the first frame such that when the splint is worn by the patient, the fin is near the molars ([Col.5], lines 10-14) of Liptak et al.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Quaka et al. as applied to claim 1 above, and further in view of Hakimi U.S. Publication No. (2014/0090652 A1).
With respect to claim 7, Quaka et al. substantially discloses the invention as claimed except a concave surface configured to move and raise a tongue of the user to a lingual position to open an airway of the user.
Hakimi however, teaches an intraoral devices designed to position the tongue and jaw so as to prevent and treat snoring and sleep apnea [0001] comprising a tongue cavity having a concave surface [0035] and (figs.3B-C and 4).
In view of the teachings of Hakimi, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the oral appliance for treating sleep apnea of Quaka et al. by incorporating a concave surface configured to move and raise a tongue of the user to a lingual position to open an airway of the user in order for positioning of the tongue in a forward position which increases the distance between the tongue and the uvula and soft palate; this forward positioning of the tongue complements the shifting of the lower jaw forward relative to the upper jaw, and assists in increasing the volumetric capacity of the user's upper airway. This prevents apnea and also reduces turbulent airflow, lowering the possibility of vibration of the uvula and soft palate [0035] of Hakimi.
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Quaka does not teach or otherwise disclose that the second appliance frame can be moved by the user while said oral appliance is being used) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, the current amendment “while the oral appliance is worn by the user” is fairly broad and is being interpreted as, when the oral appliance is initially fitted in the mouth, it is generally considered being worn at that moment, as it is in position and covering the teeth, during the fitting process as described in ([Col.4], lines 34-47).
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 OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786