9DETAILED 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
Applicant’s amendments of claim 1 is acknowledged by the Examiner.
Currently claims 1, and 4-20 are pending in the application.
Response to Arguments
Applicant's arguments filed 10/01/2025 have been fully considered but they are not persuasive.
In regards to Applicant’s arguments that the device of Vaska et al. (US 2011/0220124 A1) does not show a palatal element as recited in claim 1 which is molded from and shaped to conform to the subject’s hard palate. Examiner respectfully disagrees. The reference Frantz et al. (US 5,947,724) teaches the U-shaped element (15/17) and the palatal overlay element (12) are formed in the shape of a mold taken of the upper teeth of the subject and at least a portion of the subject's hard palate (see [Col 6 ln 55-57] and [Col 7 ln 13-16] and therefore a mold of the hard palate) such that the U-shaped element has a bite profile of the subject (see [abstract], [Col 2 ln 1-42], and [Col 7 ln 10-26]) for the purpose of custom fitting the oral device to the user’s oral cavity and associated features (see [Col 6 ln 50-55]). Therefore, the device of Vaska as modified by Frantz is molded from a mold of the upper teeth and hard palate of the subject. Furthermore, it can be seen in figure.
In regards to Applicant’s arguments that the embodiment of the device of Vaska et al. (US 2011/0220124 A1) seen in figures 12a-e does not show a palatal element as recited in claim 1 which is shaped to conform to the subject’s hard palate. Examiner agrees. However, in the current round of prosecution, and based on the amendments to the claims, Examiner relies upon a different embodiment (340) of Vaska et al. seen in figures 15a-d which has a palatal element (341) which is contemplated as being shaped to conform to the user’s hard palate as described in ([0086]) stating “In this embodiment, superior wall 344A is shaped so as to conform generally to the shape of the hard palate and there will be little or no space between superior wall 344A and the surface of the hard palate when oral device 340A is positioned in the oral cavity”. In regards to Applicant’s arguments that the devices of Vaska does not stabilize the tongue in a superior direction and depresses the tongue away from the hard palate. Examiner respectfully disagrees. Each embodiment of the device of Vaska is very clearly described to function by stabilizing the tongue in a superior direction in (see [0012]) stating: “the present invention provides methods and devices for improving airway patency in patients by drawing an anterior region of the tongue upwardly (in a superior direction toward the top of the head)”.
The remainder of Applicant’s arguments are drawn to the now unrelied upon embodiment of figures 12a-e. As stated above, in this round of prosecution, and in view of Applicant’s amendments. The Examiner now relies on the embodiment of the device of Vaska seen in figures 15a-d.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, and 4-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaska et al. (US 2011/0220124 A1) in view of Frantz et al. (US 5,947, 724) (hereinafter Frantz).
In regards to claim 1, Vaska discloses an oral appliance (340; see [0085]; see figure 15a) for treating a sleep disorder in a subject (see [0003]), the oral appliance (340) comprising:
a) a U-shaped element (343; see [0085]; see figure 15a) having an outer side wall (outer wall of 343; see figure 15a and 15d), an inner side wall (inner wall of 343; see figure 15a and 15d), and at least one biting surface (biting surface of 343; see figure 15a-d), the outer side wall, the inner side wall, and the at least one biting surface together defining at least one channel configured to receive at least one upper tooth of the subject (see figure 15d);
b) a palatal overlay element (341; see [0085]; see figures 15a-d) contiguous with the U-shaped element (343; see figure 15a-d), the palatal overlay element (341) having an interior surface (interior surface of 346 adjacent 342; see figure 15d) and an exterior surface (lower surface of 346 which faces a user’s tongue; see figure 15d) and defining a plurality of perforations (352; see [0085]; see figure 15a) extending through the palatal overlay element (341) between the interior and exterior surfaces (figure 15d that 352 extends through 346 and thus extends between the interior and exterior surfaces of 346); wherein the palatal overlay element (341) is shaped to conform to the subject’s hard palate (see [0086] that 344 of 341 can be shaped to conform to the shape of the hard palate); wherein the U-shaped element (343) and the palatal overlay element (341) are respective portions of a monolithic body (see figures 15a-d that 340 is a monolithic body with 341 and 343 being respective portions of 340);
c) a port (342; see [0085]; see figure 15a and 15d) in fluid communication with the plurality of perforations (352) of the palatal overlay element (341; see [0085]), wherein the port (342) is configured to communicate negative pressure to the plurality of perforations (352) of the palatal overlay element (341; see [0085]);
wherein the exterior surface of the palatal overlay element (341) is configured to engage at least a portion of a dorsal surface of the subject's tongue in response to application of negative pressure through the plurality of perforations (352) of the palatal overlay element (341) such that the tongue of the subject is stabilized in a superior direction toward the subject’s hard palate (see [0012] and [0085]).
Vaska does not disclose wherein the U-shaped element and the palatal overlay element are formed in the shape of a mold taken of the upper teeth of the subject and the hard palate of the subject, such that the U-shaped element has a bite profile of the subject.
However, Frantz teaches an analogous oral appliance (10; see [Col 3 ln 24-35]; see figure 1) for the treatment of sleep apnea (see [Col 1 ln 12-13]) comprising a u-shaped element (15/17; see [Col 3 ln 25-35]; see figure 9) and palatal overlay element (12;see [Col 3 ln 25-35]; see figure 1) wherein the U-shaped element (15/17) and the palatal overlay element (12) are formed in the shape of a mold taken of the upper teeth of the subject and the subject's hard palate (see [Col 6 ln 55-57] and [Col 7 ln 13-16]) such that the U-shaped element has a bite profile of the subject (see [abstract], [Col 2 ln 1-42], and [Col 7 ln 10-26]) for the purpose of custom fitting the oral device to the user’s oral cavity and associated features (see [Col 6 ln 50-55]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the U-shaped element and the palatal overlay element as disclosed by Vaska by using a mold taken of the upper teeth of the subject and the subject's hard palate as taught by Frantz in order to have provided an improved U-shaped element and the palatal overlay element that is custom fitted to the user’s oral cavity and associated features (see [Col 6 ln 50-55]) thereby increasing patient comfort when using the device.
In regards to claim 4, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses wherein at least one of the U-shaped element (343) or the palatal overlay element (341) comprises a thermoplastic, a silicone, an acrylic, a tacky polymer, a wet-tolerant adhesive, or a combination thereof (see [0073] in reference to 288 being formed of porous polyethylene which is a thermoplastic; as described in [0085] “an oral device 340 according to the invention similar in many respects to oral device 280”; thus, 341 is considered formed from the same material).
In regards to claim 5, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses wherein the plurality of perforations (352) includes more than two perforations (see figure 15a that there are 19 perforations 352).
In regards to claim 6, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses wherein the plurality of perforations (352) includes two to twenty-four perforations (see figure 15a that there are 19 perforations 352).
In regards to claim 7, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses wherein the plurality of perforations (352) includes four to eight perforations (see figure 15a that there are 19 perforations 352; thus the plurality of perforations includes four to eight perforations).
In regards to claim 8, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska does not disclose wherein the plurality of perforations (352) includes four to six perforations (see figure 15a that there are 19 perforations 352; thus the plurality of perforations includes four to six perforations).
In regards to claim 9, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska does not disclose wherein the plurality of perforations (352) has six perforations (see figure 15a that there are 19 perforations 352; thus the plurality of perforations has six perforations).
In regards to claim 10, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses wherein the port (342) is positioned within a posterior region of the oral appliance (340; see figure 15d that 342 is positioned within a posterior region of 340).
In regards to claim 11, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses wherein the port (342) is positioned within an anterior region of the oral appliance (340; see figure 15d that 342 is positioned within an anterior region of 340).
In regards to claim 12, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses wherein the port (342) is configured to be positioned near a molar tooth of the subject when the oral appliance (340) is inserted into an oral cavity of the subject (see figure 15d that 342 is positioned within a posterior region of 340 and thus, is configured to be positioned near a molar tooth of the subject).
In regards to claim 13, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses wherein the port (342) is configured to be positioned near an incisor tooth of the subject when the oral appliance (340) is inserted into an oral cavity of the subject (340; see figure 15d that 342 is positioned within an anterior region of 340, and thus is positioned near an incisor tooth of the subject located at an anterior of the subject’s oral cavity).
In regards to claim 14, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses further comprising a source of negative pressure (vacuum source; see [0085]) in fluid communication with the port (342; see [0085]).
In regards to claim 15, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses further comprising a tube (348; see [0085]; see figure 15a) that provides fluid communication between the source of negative pressure (vacuum source) and the port (342; see [0085]).
In regards to claim 16, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses wherein the source of negative pressure (vacuum source) is a vacuum pump (see [0074] that the vacuum source of the embodiment of 12a-e is described as being a vacuum pump; therefore because 340 is similar to that of 280 (see [0085]) the vacuum source described in [0085] is considered a vacuum pump).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaska in view of Frantz as applied to claim 14 above, and further in view of Chen et al. (US 2009/0288660 A1) (hereinafter Chen).
In regards to claim 17, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska further discloses the source of negative pressure can be a portable battery powered vacuum pump (see [0066]) which implies a small vacuum pump.
Vaska as now modified by Frantz does not explicitly disclose wherein the source of negative pressure is a micropump.
However, Chen teaches an analogous oral device (3; see [0036]; see figure 6a) for the analogous treatment of a sleep disorder in a subject (see [0002]) which utilizes an analogous source of negative pressure (320; see [0036]; see figure 6a) wherein the source of negative pressure (320) is a micropump (see [0038]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the portable battery powered vacuum pump source of negative pressure as disclosed by Vaska as now modified by Frantz and to have utilized a micropump as the source of negative pressure as taught by Chen in order to have provided an improved oral appliance with a smaller sized source of negative pressure increasing the portability and ease of use of the oral appliance.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaska in view of Frantz as applied to claim 14 above, and further in view of Vaska et al. (US 2017/0216085 A1) (hereinafter Vaska ‘085).
In regards to claim 18, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska as now modified by Frantz does not disclose wherein the source of negative pressure is configured to generate a pressure of at least about -5 cm H20.
However, Vaska ‘085 teaches an analogous oral appliance (10; see [0031]; see figure 3b) for the analogous treatment of a sleep disorder in a subject (see [abstract]) utilizing an analogous source of negative pressure (vacuum source; see [0016]) wherein the source of negative pressure (vacuum source) is configured to generate a pressure of at least about -5 cm H20 (see [0030] in reference to draw a vacuum in the range preferably from 5 cm H20 to 150 cm H20 (given that the vacuum is a negative pressure, these values are -5 cm H20 to -150 cm H20); which is at least -5cm H20) for the purpose of providing a sufficient force to clear the patient’s airway (see [0031]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the source of negative pressure as disclosed by Vaska as now modified by Frantz to generate a pressure of at least about -5 cm H20 as taught by Vaska ‘085 in order to have provided an improved source of negative pressure which would provide a sufficient force to clear the patient’s airway (see [0031]) while also being configurable to minimize patient discomfort.
In regards to claim 19, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska as now modified by Frantz does not disclose wherein the source of negative pressure is configured to generate a pressure between about -5 cm H20 to about -20 cm H20.
However, Vaska ‘085 teaches an analogous oral appliance (10; see [0031]; see figure 3b) for the analogous treatment of a sleep disorder in a subject (see [abstract]) utilizing an analogous source of negative pressure (vacuum source; see [0016]) wherein the source of negative pressure (vacuum source) is configured to generate a pressure of between about -5 cm H20 to about -20 cm H20 (see [0030] in reference to draw a vacuum in the range preferably from 5 cm H20 to 150 cm H20 (given that the vacuum is a negative pressure, these values are -5 cm H20 to -150 cm H20); which is at least -5cm H20) for the purpose of providing a sufficient force to clear the patient’s airway (see [0031]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the source of negative pressure as disclosed by Vaska as now modified by Frantz to generate a pressure of between about -5 cm H20 to about -150 cm H20 as taught by Vaska ‘085 in order to have provided an improved source of negative pressure which would provide a sufficient force to clear the patient’s airway (see [0031]) while also being configurable to minimize patient discomfort.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the negative pressure generated as disclosed by Vaska as now modified by Frantz and Vaska ‘085 from -5 cm H20 to about -150 cm H20 to -5 cm H20 to about -20 cm H20 as applicant appears to have placed no criticality on the range (see Specification [0047] in reference to multiple ranges of negative pressure including at least -5, between -5-20, and -5-10 cm H20 being considered) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 20, Vaska as now modified by Frantz discloses the invention as discussed above.
Vaska as now modified by Frantz does not disclose wherein the source of negative pressure is configured to generate a pressure between about -5 cm H2O to about -10 cm H2O.
However, Vaska ‘085 teaches an analogous oral appliance (10; see [0031]; see figure 3b) for the analogous treatment of a sleep disorder in a subject (see [abstract]) utilizing an analogous source of negative pressure (vacuum source; see [0016]) wherein the source of negative pressure (vacuum source) is configured to generate a pressure of between about -5 cm H20 to about -10 cm H20 (see [0030] in reference to draw a vacuum in the range preferably from 5 cm H20 to 150 cm H20 (given that the vacuum is a negative pressure, these values are -5 cm H20 to -150 cm H20); which is at least -5cm H20) for the purpose of providing a sufficient force to clear the patient’s airway (see [0031]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the source of negative pressure as disclosed by Vaska as now modified by Frantz to generate a pressure of between about -5 cm H20 to about -150 cm H20 as taught by Vaska ‘085 in order to have provided an improved source of negative pressure which would provide a sufficient force to clear the patient’s airway (see [0031]) while also being configurable to minimize patient discomfort.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the negative pressure generated as disclosed by Vaska as now modified by Frantz, and Vaska ‘085 from -5 cm H20 to about -150 cm H20 to -5 cm H20 to about -10 cm H20 as applicant appears to have placed no criticality on the range (see Specification [0047] in reference to multiple ranges of negative pressure including at least -5, between -5-20, and -5-10 cm H20 being considered) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
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/DANIEL A MILLER/ Examiner, Art Unit 3786