DETAILED ACTION
This action is in response to the application filed 2/6/2024. Currently, claims 1-12 are pending in the application.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “130” and “132.” Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “134” has been used to designate both the tongue and the soft palate region (see Figure 1). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “disposed near anterior portion of the hard palate, enabling anterior portion of tongue” should be amended to recite ---disposed near an anterior portion of the hard palate, enabling an anterior portion of tongue---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the mouth region” should be amended to recite ---the mouth region of the subject---. Appropriate correction is required.
Claims 1-12 are objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), all recitations of “the apparatus” should be amended to recite ---the apparatus 100---. Appropriate correction is required.
Claims 1, 3 and 4 are objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), all recitations of “the hollow plate” should be amended to recite ---the hollow plate 102---. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “present at surface of the upper portion 112 and surface of the lower portion 114” should be amended to recite ---present at a surface of the upper portion 112 and a surface of the lower portion 114---. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the notch 150” in line 2 of the claim should be amended to recite ---the V-shaped notch 150---. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: in order to correct a grammatical error, “and further avoiding” should be amended to recite ---and further avoids---. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “disposed near anterior portion of the hard palate, enabling anterior portion of tongue” should be amended to recite ---disposed near an anterior portion of the hard palate, enabling an anterior portion of tongue---. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the mouth region” should be amended to recite ---the mouth region of the subject---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the limitations “the sleep disorder,” “the subject” and “the posterior portion 124.” There is insufficient antecedent basis for these limitations in the claim. Claims 2-11 depend on claim 1 and therefore, include the same error.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 4, the phrase "may be" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 5 recites the limitation "the thickness" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 12 recites the limitations “the sleep disorder,” “the subject” and “the posterior portion 124.”
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.
Claims 1-11 are rejected under 35 U.S.C. 101 because 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 1-11 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). Claim 1 recites “a bulge member 104, attached with the lower portion 114, about an anterior portion 122 of the hollow plate 102 and disposed near anterior portion of the hard palate,” which is a claim limitation indicating that Applicant is attempting to claim the hard palate (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claims 2-11 depend on claim 1 and therefore, include the same error.
Claim 2 is rejected under 35 U.S.C. 101 because 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.
Claim 2 is 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). Claim 2 recites “the orifice 106 is disposed about a central incisor portion of the subject,” which is a claim limitation indicating that Applicant is attempting to claim a central incisor portion of the subject (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error.
Claim 12 is rejected under 35 U.S.C. 101 because 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.
Claim 12 is 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). Claim 12 recites “a bulge member 104, attached about an anterior portion 122 of the hollow plate 102 and disposed near anterior portion of the hard palate,” which is a claim limitation indicating that Applicant is attempting to claim the hard palate (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error.
Claim Rejections - 35 USC § 103
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) 1-5 and 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heeke et al. (US 2005/0150504 A1) in view of Hart et al. (US 2018/0207020 A1).
In regards to claim 1, Heeke et al. teaches in Figures 1-5, [0036-0037], [0042] and [0058] a hollow plate 102 (device 10; taught in Figures 1-5 to be structured as a plate, including plate-like bridge 30; [0036] teaches “the device 10 of the present invention also includes means 14 for connecting the device to a source of pressurized air (not shown) and defines a central conduit C for delivering the pressurized air through the oral cavity to the rear of the mouth proximate to the throat;” [0042] teaches “a central air passage C through the device 10;” [0058] teaches “the air flow channel C is defined by the lower surface 33 of upper member 12 and the upper surface 52 of lower member 14;” central conduit C is a hollow interior), defined by (as shown in Figure 2) an upper portion 112 (upper member 12) and a lower portion 114 (lower or central plate member 14), with the lower portion 114 (lower or central plate member 14) connected and being co-extensive with ([0036] teaches “a lower or central plate member 14 which is removably connected to the upper member 12 or palatal shell and cooperatively acts with the palatal shell 12”) the upper portion 112 (upper member 12), the upper portion 112 (upper member 12) configured to register along a maxillary surface 108 of the subject (as shown in Figure 1; [0036] teaches “an upper member 12 also referred to as a palatal shell adapted to be secured to the region of the user's mouth at or near the rear teeth;” [0037] teaches “the palatal shell 12 has upper depressions and lower depressions adapted to releasably receive the upper teeth as well as lower posterior teeth, preferably including molars 20 and second bicuspid 22”), wherein the lower portion 114 (lower or central plate member 14) of the hollow plate (device 10) is detachable from the upper portion 112 (upper member 12) whenever desired by the subject ([0036] teaches “a lower or central plate member 14 which is removably connected to the upper member 12 or palatal shell and cooperatively acts with the palatal shell 12”); and an orifice 106 (external air connection means 16), configured to allow airflow towards the posterior portion 124 of the hollow plate 102 (device 10) from the anterior portion 122 of the hollow plate 102 (as shown in Figure 1; [0036] teaches “the device 10 of the present invention also includes means 14 for connecting the device to a source of pressurized air (not shown) and defines a central conduit C for delivering the pressurized air through the oral cavity to the rear of the mouth proximate to the throat;” [0042] teaches “a central air passage C through the device 10 from the region proximate to the frontal upper incisors 38 to the rear of the device proximate to the region where the soft palate and hard palate meet”), the orifice 106 (external air connection means 16) disposed at the anterior portion 122 of (as shown in Figure 1) the hollow plate 102 (device 10).
Heeke et al. does not teach a bulge member 104, attached with the lower portion 114, about an anterior portion 122 of the hollow plate 102 and disposed near anterior portion of the hard palate, enabling anterior portion of tongue of the subject in a resting position within the bulge member 104 and preventing the tongue of the subject to retract towards the mouth region.
However, Hart et al. teaches in Figures 1A-1C and 1E-1G and [0226] an analogous device with a bulge member 104 (lingual flange 130), attached with (as shown in Figures 1E-1G) the lower portion 114 (lower face 113.22), about an anterior portion 122 of the hollow plate 102 and disposed near anterior portion of the hard palate (Figures 1A-1C and 1E-1G teach the lingual flange 130 being positioned at the anterior apex of body 110, such that the lingual flange 130 would be positioned near an anterior portion of the hard palate in use), enabling anterior portion of tongue of the subject in a resting position within ([0226] teaches “a second side 132 of the lingual flange can be provided to define a pocket for receiving the user's tongue”) the bulge member 104 (lingual flange 130) and preventing the tongue of the subject to retract towards the mouth region ([0226] teaches “the second side 132 is of a concave shape, so that when the tongue abuts against the lingual flange 132 a suction effect is created, thereby helping to retain the user's tongue towards the anterior of the oral cavity”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the device of Heeke et al. to include a bulge member 104, attached with the lower portion 114, about an anterior portion 122 of the hollow plate 102 and disposed near anterior portion of the hard palate, enabling anterior portion of tongue of the subject in a resting position within the bulge member 104 and preventing the tongue of the subject to retract towards the mouth region as taught by Hart et al. because this element is known to “further reduce airway obstruction caused by the position of the user's tongue,” as Hart et al. teaches in [0226].
In regards to claim 2, Heeke et al. and Hart et al. teach the apparatus of claim 1. Heeke et al. teaches in Figure 1 that the orifice 106 (external air connection means 16) is disposed about a central incisor portion (frontal upper incisors 38) of the subject (Figure 1 teaches the external air connection means 16 being positioned adjacent the frontal upper incisors 38), on the anterior portion 122 of (Figures 1 and 2 teach the external air connection means 16 being positioned at the front of device 10) the hollow plate 102 (device 10).
In regards to claim 3, Heeke et al. and Hart et al. teach the apparatus of claim 1. Heeke et al. teaches in Figure 2 and [0055-0056] that the upper portion 112 (upper member 12) and the lower portion 114 (lower or central plate member 14) of the hollow plate (device 10) are connected via an interlocking arrangement, present at surface of (as taught in [0055-0056]) the upper portion 112 (upper member 12) and surface of the lower portion 114 (lower or central plate member 14).
In regards to claim 4, Heeke et al. and Hart et al. teach the apparatus of claim 1. Heeke et al. teaches in Figure 2 and [0056] that the lower portion 114 (lower or central plate member 14) of the hollow plate (device 10) may be connected to the upper portion 112 (upper member 12) of the hollow plate (device 10) either via an undercut arrangement implemented in the lower portion 114 and the upper portion 112, or via a press fit arrangement ([0056] teaches “pins 96, 98 protrude laterally outward from side edges 76, 78 and are adapted to be releasably received in mating bores 100, 102 located in upper member 12”).
In regards to claim 5, Heeke et al. and Hart et al. teach the apparatus of claim 1. Heeke et al. and Hart et al. do not teach that the thickness associated with the hollow plate 102 between the upper portion 112 and the lower portion 114 is at least 2 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the thickness associated with the hollow plate 102 between the upper portion 112 and the lower portion 114 is at least 2 mm, since it has been held that where the general conditions of a claim are disclosed in t he prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the thickness associated with the hollow plate 102 between the upper portion 112 and the lower portion 114 could be modified in order to more comfortably accommodate the anatomy of each individual user.
In regards to claim 7, Heeke et al. and Hart et al. teach the apparatus of claim 1. Heeke et al. and Hart et al. do not teach that the material of the apparatus 100 and the bulge member 104 is Ethyl Vinyl Acetate.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the material of the apparatus 100 and the bulge member 104 is Ethyl Vinyl Acetate, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
In regards to claim 8, Heeke et al. and Hart et al. teach the apparatus of claim 1. Heeke et al. teaches in [0034] that the material of the apparatus 100 is epoxy (polymer) resin ([0034] teaches “the oral device of the present invention is composed of a polymethylmethacrylate resin independent of or in combination with a methylmethacrylate resin”).
Claim 8 limitation “wherein the apparatus 100 is fabricated using 3D printing technique” is a product-by-process claim limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
In regards to claim 9, Heeke et al. and Hart et al. teach the apparatus of claim 1. Heeke et al. does not teach that the bulge member 104 prevents the slipping out of the tongue of the subject from the bulge member 104, and further avoiding retraction of the tongue towards the mouth region of the subject.
However, Hart et al. teaches in [0226] and [0245] an analogous device wherein the bulge member 104 (lingual flange 130) prevents the slipping out of the tongue of the subject from the bulge member 104 (lingual flange 130), and further avoiding retraction of the tongue towards the mouth region of the subject ([0226] teaches “the second side 132 is of a concave shape, so that when the tongue abuts against the lingual flange 132 a suction effect is created, thereby helping to retain the user's tongue towards the anterior of the oral cavity, which in turn helps further reduce airway obstruction caused by the position of the user's tongue;” [0245] teaches “the concave inner surface of the tongue flange, together with an optional tongue recess, can also act as a suction cup to hold the tongue forward”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the bulge member 104 of Heeke et al. as modified by Hart et al. to provide that the bulge member 104 prevents the slipping out of the tongue of the subject from the bulge member 104, and further avoiding retraction of the tongue towards the mouth region of the subject as taught by Hart et al. because this element is known to “further reduce airway obstruction caused by the position of the user's tongue,” as Hart et al. teaches in [0226].
In regards to claim 10, Heeke et al. and Hart et al. teach the apparatus of claim 1. Heeke et al. teaches in Figure 2, [0037-0038] and [0057] that the apparatus 100 comprises an upper curved plate portion 142 (upper biting surfaces 24, retentive portion 26, plate-like bridge 30, biting surface 110; [0038] teaches “a plate-like bridge 30 conforming to the back of the maxillary anterior teeth and the upper palate of the wearer joins the two respective upper biting surfaces 24”) having a maxillary teeth receptacle 144 (upper biting surfaces 24, retentive portion 26, biting surface 110; [0037] teaches “a retentive portion 26 of the upper member 12 fits over the upper four posterior teeth on both sides of the jaw”), disposed about the anterior portion 122 of ([0057] teaches “the front edge region 68 is configured with a biting surface 110 which will cover the biting edge of all associated front teeth”) the hollow plate 102 (device 10).
In regards to claim 11, Heeke et al. and Hart et al. teach the apparatus of claims 1 and 10. Heeke et al. teaches in Figure 2, [0037-0038] and [0057] that the upper curved plate portion 142 (upper biting surfaces 24, retentive portion 26, plate-like bridge 30, biting surface 110) is configured to receive and hold at least an anterior portion of the maxillary teeth 146 ([0037] teaches “the palatal shell 12 has upper depressions and lower depressions adapted to releasably receive the upper teeth as well as lower posterior teeth, preferably including molars 20 and second bicuspid 22 of both the upper and lower jaw are retentively secured with forward teeth being engaged,” “the depressions provide biting surfaces 24 for the aforementioned teeth” and “a retentive portion 26 of the upper member 12 fits over the upper four posterior teeth on both sides of the jaw;” [0038] teaches “a plate-like bridge 30 conforming to the back of the maxillary anterior teeth;” [0057] teaches “the front edge region 68 is configured with a biting surface 110 which will cover the biting edge of all associated front teeth”).
In regards to claim 12, Heeke et al. teaches in Figures 1-5, [0036-0037], [0042] and [0058] a hollow plate 102 (device 10; taught in Figures 1-5 to be structured as a plate, including plate-like bridge 30; [0036] teaches “the device 10 of the present invention also includes means 14 for connecting the device to a source of pressurized air (not shown) and defines a central conduit C for delivering the pressurized air through the oral cavity to the rear of the mouth proximate to the throat;” [0042] teaches “a central air passage C through the device 10;” [0058] teaches “the air flow channel C is defined by the lower surface 33 of upper member 12 and the upper surface 52 of lower member 14;” central conduit C is a hollow interior), defined by (as shown in Figure 2) an upper portion 112 (upper member 12) and a lower portion 114 (lower or central plate member 14) with the lower portion 114 (lower or central plate member 14) connected and being co-extensive with ([0036] teaches “a lower or central plate member 14 which is removably connected to the upper member 12 or palatal shell and cooperatively acts with the palatal shell 12”) the upper portion 112 (upper member 12), the upper portion 112 (upper member 12) configured to register along a maxillary surface 108 of the subject (as shown in Figure 1; [0036] teaches “an upper member 12 also referred to as a palatal shell adapted to be secured to the region of the user's mouth at or near the rear teeth;” [0037] teaches “the palatal shell 12 has upper depressions and lower depressions adapted to releasably receive the upper teeth as well as lower posterior teeth, preferably including molars 20 and second bicuspid 22”); and an orifice 106 (external air connection means 16), configured to allow airflow towards the posterior portion 124 of the hollow plate 102 from the anterior portion 122 of the hollow plate 102 (as shown in Figure 1; [0036] teaches “the device 10 of the present invention also includes means 14 for connecting the device to a source of pressurized air (not shown) and defines a central conduit C for delivering the pressurized air through the oral cavity to the rear of the mouth proximate to the throat;” [0042] teaches “a central air passage C through the device 10 from the region proximate to the frontal upper incisors 38 to the rear of the device proximate to the region where the soft palate and hard palate meet”), the orifice 106 (external air connection means 16) disposed at the anterior portion 122 of (as shown in Figure 1) the hollow plate 102 (device 10).
Heeke et al. does not teach a bulge member 104, attached about an anterior portion 122 of the hollow plate 102 and disposed near anterior portion of the hard palate, enabling anterior portion of tongue of the subject in resting position within the bulge member 104 thus preventing the tongue of the subject to retract towards the mouth region.
However, Hart et al. teaches in [0226] and [0245] an analogous device with a bulge member 104 (lingual flange 130), attached about an anterior portion 122 of the hollow plate 102 and disposed near anterior portion of the hard palate (Figures 1A-1C and 1E-1G teach the lingual flange 130 being positioned at the anterior apex of body 110, such that the lingual flange 130 would be positioned near an anterior portion of the hard palate in use), enabling anterior portion of tongue of the subject in resting position within ([0226] teaches “a second side 132 of the lingual flange can be provided to define a pocket for receiving the user's tongue”) the bulge member 104 (lingual flange 130) thus preventing the tongue of the subject to retract towards the mouth region ([0226] teaches “the second side 132 is of a concave shape, so that when the tongue abuts against the lingual flange 132 a suction effect is created, thereby helping to retain the user's tongue towards the anterior of the oral cavity”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the device of Heeke et al. to include a bulge member 104, attached about an anterior portion 122 of the hollow plate 102 and disposed near anterior portion of the hard palate, enabling anterior portion of tongue of the subject in resting position within the bulge member 104 thus preventing the tongue of the subject to retract towards the mouth region as taught by Hart et al. because this element is known to “further reduce airway obstruction caused by the position of the user's tongue,” as Hart et al. teaches in [0226].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heeke et al. (US 2005/0150504 A1), in view of Hart et al. (US 2018/0207020 A1) and further in view of DeLuke (US 6,837,246 B1).
In regards to claim 6, Heeke et al. and Hart et al. teach the apparatus of claim 1. Heeke et al. and Hart et al. do not teach that the bulge member 104 comprises a V-shaped notch 150, wherein the notch 150 enables easy entry of the tongue of the subject into the bulge member 104 and resting of the tongue frenulum of the subject.
However, DeLuke teaches in Figures 1-5 and column 2, lines 47-65 an analogous device wherein the bulge member 104 (platform 30) comprises a V-shaped notch 150 (“open region” formed between semi-cup-shaped halves 32 and 34, as shown in Figure 1 and taught in column 2, lines 47-65), wherein the notch 150 (“open region” formed between semi-cup-shaped halves 32 and 34, as shown in Figure 1 and taught in column 2, lines 47-65) enables easy entry of the tongue of the subject into (column 2, lines 53-54 teaches “platform 30 is shaped to receive and support the front portion of a patient's tongue”) the bulge member 104 (platform 30) and resting of the tongue frenulum of the subject (column 2, lines 62-63 teaches “the open space promotes comfort and mobility for the tongue and provides space for lingual frenum”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the bulge member of Heeke et al. as modified by Hart et al. to provide v=that the bulge member 104 comprises a V-shaped notch 150, wherein the notch 150 enables easy entry of the tongue of the subject into the bulge member 104 and resting of the tongue frenulum of the subject as taught by DeLuke because this element “ promotes comfort and mobility for the tongue and provides space for lingual frenum,” as DeLuke teaches in column 2, lines 62-63.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 8/5/2025