DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 02/01/2024. Claims 1-20 are pending and examined below.
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) 12-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20150045698 A1 (hereinafter referred to as “Gribb”).
Regarding claim 12, Gribb teaches An intraoral device for placement in the mouth of a subject for measuring tongue pressure (abstract), the device comprising:
a molded mouthpiece (paragraph [0051]) having an anterior end, a posterior end, a first side for placement on a roof of the mouth, a second side opposite the first side, and a molded cross-shaped portion, the molded mouthpiece including an interior part housed inside the molded mouthpiece, the interior part having a cross-shaped portion and a plurality of sensors on the cross-shaped portion, the plurality of sensors including a back sensor, a front sensor, a right sensor and a left sensor (paragraph [0055]; Figure 2; as taught by Gribb); and
a plurality of protrusions formed on an exterior of the molded cross-shaped portion of the mouthpiece on the second side of the molded mouthpiece, each protrusion at a location aligned with a corresponding sensor on the cross-shaped portion of the interior part (paragraph [0055]; Figure 2; as taught by Gribb).
Regarding claim 13, Gribb teaches the molded mouthpiece further comprising a metal support part housed inside the molded mouthpiece between the interior part and the first side of the molded mouthpiece and in a stacked configuration with the interior part (paragraph [0053]).
Regarding claim 14, Gribb teaches wherein the cross-shaped portion of the interior part comprises a longitudinal portion, extending from the anterior end of the mouthpiece towards the posterior end of the mouthpiece, and a latitudinal portion generally perpendicular to the longitudinal portion (paragraph [0055]; Figure 2; as taught by Gribb).
Regarding claim 15, Gribb teaches wherein a size and shape of the metal support part is similar to the longitudinal portion of the interior part such that a second part of the molded cross-shaped portion of the molded mouthpiece is more flexible relative to a first part of the molded cross-shaped portion (paragraph [0055]; Figure 2; as taught by Gribb).
Regarding claim 16, Gribb teaches wherein the device operates wirelessly and is configured to communicate data to a tablet or computing device (paragraph [0058], [0083]; as taught by Gribb).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-9, 11 is/are rejected under 35 U.S.C. 103 as being obvious by US 20150045698 A1 (hereinafter referred to as “Gribb”) in view of US 20160213306 A1 (hereinafter referred to as “Searl”) and US 20160030802 A1 (hereinafter referred to as “Hagg”).
Regarding claim 1, Gribb teaches an intraoral device configured for placement in the mouth of a subject (paragraph [0050]; Figure 1), the device comprising:
a mouthpiece having a roof side and a tongue side and including a cross-shaped portion (paragraph [0057]; Figures 1-2), the mouthpiece comprising:
a first interior part having a cross-shaped component, formed by a first portion and a second portion perpendicular to the first portion (paragraph [0050]; Figures 1-2), and a plurality of sensors at spaced apart locations on the first and second portions (paragraph [0055]; Figure 2); and
wherein the first interior part corresponds with the cross-shaped portion of the mouthpiece and is in contact with the tongue side of the mouthpiece (paragraphs [0057]; Figures 1-2).
Gribb does not explicitly teach
a second interior part having a component that corresponds in size and shape with the first portion of the first interior part, wherein the first and second interior parts are in a stacked configuration inside the mouthpiece such that the first interior part corresponds with the cross-shaped portion of the mouthpiece and is in contact with the tongue side of the mouthpiece, and the second interior part is in contact with the roof side of the mouthpiece, and a second part of the cross-shaped portion of the mouthpiece is more flexible than a first part of the cross-shaped portion of the mouthpiece; and a handheld portion connected to the mouthpiece and configured for placing and removably securing the mouthpiece in the mouth of the subject.
However, Searl teaches a tongue plate pressure sensing body comprising a plurality of material layers (paragraph [0024]; Figures 1-2), and further teaches providing different structural characteristics at different portions of the palatal body (“regions of increased structural reinforcement provide additional strength, while less reinforced regions provide additional flexibility; paragraph [0029]; Figure 2). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Gribb, to have a plurality of layers with different structural characteristics, as taught by Searly, thus yielding a second interior part having a component that corresponds in size and shape with the first portion of the first interior part, wherein the first and second interior parts are in a stacked configuration inside the mouthpiece such that the first interior part corresponds with the cross-shaped portion of the mouthpiece and is in contact with the tongue side of the mouthpiece, and the second interior part is in contact with the roof side of the mouthpiece, and a second part of the cross-shaped portion of the mouthpiece is more flexible than a first part of the cross-shaped portion of the mouthpiece, because doing so would predictably provide increased structural support.
Further Hagg teaches a handheld portion connected to an intraoral tongue pressure sensing portion (connected to handle 2 and grip 3; paragraph [0028]; Figures 1-4). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Gribb, in view of Searl, to have a handle, as taught by Hagg, because doing so allows for user or physician to better position the device in the desired position.
Regarding claim 2, Gribb, in view of Searl and Hagg, teaches wherein an extension piece connects the handheld portion to the mouthpiece and the extension piece includes a curved portion (as shown in Figure 1; as taught by Hagg).
Regarding claim 3, Gribb, in view of Searl and Hagg, teaches wherein the plurality of sensors comprises an anterior sensor on an anterior end of the first portion of the cross-shaped component of the first interior part and a posterior sensor on a posterior end of the first portion of the cross-shaped component of the first interior part (paragraph [0055]; Figure 2; as taught by Gribb).
Regarding claim 4, Gribb, in view of Searl and Hagg, teaches wherein the plurality of sensors comprises a left sensor on the second portion of the cross-shaped component of the first interior part and a right sensor opposite of the left sensor on the second portion of the cross-shaped component of the first interior part (paragraph [0055]; Figure 2; as taught by Gribb).
Regarding claim 5, Gribb, in view of Searl and Hagg, teaches wherein the plurality of sensors include force sensing resistors (paragraph [0063]; as taught by Gribb).
Regarding claim 6, Gribb, in view of Searl and Hagg, teaches wherein the mouthpiece is formed of a thermoplastic elastomer (paragraph [0069]).
Regarding claim 7, Gribb, in view of Searl and Hagg, teaches wherein the mouthpiece is formed by a molding process (paragraph [0051]; as taught by Gribb).
Regarding claim 8, Gribb, in view of Searl and Hagg, teaches wherein the molded mouthpiece includes a plurality of protrusions formed on an exterior of the molded mouthpiece on the tongue side, and a location of each protrusion on the molded mouthpiece corresponds with a location of a sensor on the cross-shaped component of the first interior part (paragraph [0055]; as shown in Figure 2; as taught by Gribb).
Regarding claim 9, Gribb, in view of Searl and Hagg, teaches wherein the protrusions are dome shaped (paragraph [0055]; as shown in Figure 2; as taught by Gribb).
Regarding claim 11, Gribb, in view of Searl and Hagg, teaches wherein the mouthpiece includes a bite locator at an anterior end of the mouthpiece, the bite locator comprises a first ridge and a second ridge separated by a cavity (paragraphs [0067], [0070]-[0071]; Figure 1; as taught by Gribb).
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being obvious by Gribb, in view of Searl.
Regarding claim 17, Gribb teaches A method of assessing an individual having dysphagia using an intraoral device (paragraph [0050]; Figure 1), the method comprising:
placing the intraoral device in a mouth of the individual (paragraph [0055]; Figure 1-2), the intraoral device comprising:
a molded mouthpiece having a molded cross-shaped portion formed by a first portion and a second portion perpendicular to the first portion, the molded mouthpiece including an interior component housed inside the molded mouthpiece, the interior component having a cross-shaped portion and a plurality of sensors on the cross-shaped portion, the plurality of sensors including a posterior sensor aligned with the first portion of the molded cross-shaped portion, an anterior sensor aligned with an opposite end of the first portion, a first side sensor aligned with the second part of the molded cross-shaped portion and a second side sensor aligned with an opposite end of the second part (paragraph [0050], [0055]; Figure 1-2);
adjusting the intraoral device to position the plurality of sensors to contours of a roof of the mouth (paragraph [0050], [0055]; Figure 1-2), the second part of the molded cross-shaped portion being more flexible than the first portion of the molded cross-shaped portion;
measuring tongue pressure on each of the sensors and collecting data from each of the sensors (paragraph [0050], [0055]; Figure 1-2); and
transmitting the data wirelessly to a computing device (paragraph [0058], [0083]; as taught by Gribb).
Gribb does not explicitly teach the second part of the molded cross-shaped portion being more flexible than the first portion of the molded cross-shaped portion.
However, Searl teaches a tongue plate pressure sensing body comprising a plurality of material layers (paragraph [0024]; Figures 1-2), and further teaches providing different structural characteristics at different portions of the palatal body (“regions of increased structural reinforcement provide additional strength, while less reinforced regions provide additional flexibility; paragraph [0029]; Figure 2). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Gribb, to have different structural characteristics, as taught by Searly, thus yielding the second part of the molded cross-shaped portion being more flexible than the first portion of the molded cross-shaped portion, because doing so would allows for added flexibility for desired user.
Regarding claim 18, Gribb, in view of Searl, teaches wherein the intraoral device comprises a bite locator configured to receive the individual's teeth or gums during placement of the intraoral device in the mouth (paragraphs [0067], [0070]-[0071]; Figure 1; as taught by Gribb).
Regarding claim 19, Gribb, in view of Searl, teaches wherein the bite locator includes a first ridge and a second ridge at an anterior end of the molded mouthpiece, and a cavity separates the first ridge from the second ridge (paragraphs [0067], [0070]-[0071]; Figure 1; as taught by Gribb).
Regarding claim 20, Gribb, in view of Searl, teaches the intraoral device further comprising: a plurality of protrusions formed on an exterior of the molded cross-shaped portion of the mouthpiece, each protrusion at a location aligned with a corresponding sensor on the cross-shaped portion of the interior part (as shown in Figure 2).
Allowable Subject Matter
Claim 10 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 10, the prior art does not teach or suggest “wherein a thickness of the mouthpiece at a posterior end of the mouthpiece is greater than a thickness of the mouthpiece at an anterior end of the mouthpiece and the mouthpiece includes a ramp on the first part of the cross-shaped portion of the mouthpiece near the posterior end” in combination with all of the limitations of the base claim and any intervening claims
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791
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