DETAILED ACTION
This action is in response to the Preliminary Amendment filed 10/9/2024. Currently, claims 1-10 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.
Response to Amendment
Applicant should note that the claim amendment filed 10/9/2024 is not properly marked up to indicate all changes made to the claims. Per the MPEP, “All claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter) with 2 exceptions: (1) for deletion of five or fewer consecutive characters, double brackets may be used (e.g., [[eroor]]); (2) if strike-through cannot be easily perceived (e.g., deletion of number “4” or certain punctuation marks), double brackets must be used (e.g., [[4]]).” See MPEP 714(II)(C.)(B).
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract is not structured as a single paragraph, as required. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “said arches (12, 13)” in line 3 of the claim should be amended to recite ---said inner and outer arches (12, 13)---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “said plane (14)” in line 3 of the claim should be amended to recite ---said occlusal plane (14)---. 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 lower one” in line 6 of the claim should be amended to recite ---the lower dental arch---. 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 two dental arches” (twice recited) in lines 7 and 8 of the claim should be amended to recite ---the inner and outer arches (12, 13)---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the device (1)” in line 11 of the claim should be amended to recite ---the myofunctional device (1)---. Appropriate correction is required.
Claims 1-10 are objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), all recitations of “the device” should be amended to recite ---the myofunctional device (1)---. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the reliefs (131)” in lines 1-2 of the claim should be amended to recite ---the plurality of horizontal reliefs (131)---. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the reliefs (131)” in lines 1-2 of the claim should be amended to recite ---the plurality of horizontal reliefs (131)---. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: in order to correct a typographical error, “5,5 mm” should be amended to recite ---5.5 mm---. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the depth” in line 4 of the claim should be amended to recite ---the depth (P)---. 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 1-10 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 limitation "the same" in line 9 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claims 2-10 depend on claim 1 and therefore, include the same error.
Claims 1-10 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 limitation "the front portion of the outer arch (13)" in line 11 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claims 2-10 depend on claim 1 and therefore, include the same error.
Claims 4 and 5 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. Regarding claim 4, the phrase "intended as" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 5 depends on claim 4 and therefore, includes the same error.
Claims 6 and 7 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 6 recites the limitation "the development of the middle arch (15)" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends on claim 5 and therefore, includes the same error.
Claims 8 and 9 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 8 recites the limitation "the development of the middle arch (15)" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends on claim 8 and therefore, includes the same error.
Claims 8 and 9 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 8 recites the limitation "the front portion of the device" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends on claim 8 and therefore, includes the same error.
Claims 8 and 9 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 8 recites the limitation "the end portion" in lines 3-4 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends on claim 8 and therefore, includes the same error.
Claim 9 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 9 recites the limitation "the portion at the rear of the position (C) of the upper canine tooth" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 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 9 recites the limitation "the canine position" in lines 3-4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 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 9 recites the limitation "the front portion of the device" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 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 10 recites the limitation "the development of said occlusal plane (14)" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
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 1-10 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 1-10 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 10 recites “the occlusal plane (14) is arranged between the upper dental arch of the patient and the lower one,” which is a claim limitation indicating that Applicant is attempting to claim the upper and lower dental arches (which are non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claims 2-10 depend on claim 1 and therefore, include the same error.
Claims 1-10 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 1-10 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 10 recites “- the inner arch (12) is arranged inside the two dental arches of the patient, - the outer arch (13) is arranged outside the two dental arches, in the space comprised between the same and the inner mucosa of cheeks and lips,” which is a claim limitation indicating that Applicant is attempting to claim the two dental arches of the patient, and the inner mucosa of cheeks and lips (which are non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claims 2-10 depend on claim 1 and therefore, include the same error.
Claim 9 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 9 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 9 recites “said occlusal plane (14) has a constant thickness (S') in the portion at the rear of the position (C) of the upper canine tooth, and an increasing thickness from the canine position to the front portion of the device,” which is a claim limitation indicating that Applicant is attempting to claim the upper canine tooth (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error.
Claim Rejections - 35 USC § 102
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 and 6-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farrell (US 5,259,762 A).
In regards to claim 1, Farrell teaches in Figure 1, column 4, lines 3-12 and column 5, lines 66-68
an inner arch (inner flange portion 13) and an outer arch (outer flange portion 12) connected to each other by (as shown in Figure 1; column 4, lines 3-6 teaches “base portion 11 is provided along its leading edge with an outer flange portion 12 and along its trailing edge with an inner flange portion 13”) an occlusal plane (base portion 11), said arches (inner flange portion 13, outer flange portion 12) and said plane (base portion 11) being configured to be introduced in the oral cavity of a patient (column 4, lines 6-10 teaches “the flange portions 12 and 13 define with the base portion 11 upper and lower channels 15 and 16 for receipt of the teeth of the upper and lower jaws”), so that:
- the occlusal plane (base portion 11) is arranged between the upper dental arch of the patient and the lower one (column 4, lines 6-10 teaches “the flange portions 12 and 13 define with the base portion 11 upper and lower channels 15 and 16 for receipt of the teeth of the upper and lower jaws”);
- the inner arch (inner flange portion 13) is arranged inside the two dental arches of the patient (column 4, lines 10-12 teaches “the outer and inner flange portions 12 and 13 are shaped to the labial and lingual aspects of the upper and lower jaws”),
- the outer arch (outer flange portion 12) is arranged outside the two dental arches, in the space comprised between the same and the inner mucosa of cheeks and lips (column 4, lines 10-12 teaches “the outer and inner flange portions 12 and 13 are shaped to the labial and lingual aspects of the upper and lower jaws”),
characterized in that
in the front portion (anterior surface) of the outer arch (outer flange portion 12) the device (oral appliance 10) comprises (as shown in Figure 1) a plurality of horizontal reliefs (bristles or projections 28; shown in Figure 1 to be arranged in horizontal rows; column 5, lines 66-68 teaches that the bristles or projections 28 function “to massage the gums of the user,” and thus, provide relief thereto), arranged at opposite portions to (Figure 1 teaches the bristles or projections 28 being arrange above and below the middle horizontal plane of oral appliance 10) the middle horizontal plane of the device (oral appliance 10), which is defined by said occlusal plane, in a number of at least two for any portion (Figure 1 teaches six bristles or projections 28 being arranged above the middle horizontal plane of oral appliance 10 and six bristles or projections 28 being arranged below the middle horizontal plane of oral appliance 10).
In regards to claim 2, Farrell teaches the apparatus of claim 1. Farrell teaches in Figure 1 that said reliefs (bristles or projections 28) are shaped as continuous segments (inasmuch as each individual bristle or projection 28 is shown in Figure 1 to be an unbroken structure).
In regards to claim 3, Farrell teaches the apparatus of claim 1. Farrell teaches in Figure 1 that said reliefs (bristles or projections 28) are shaped as discontinuous segments (inasmuch as each row of bristles or projections 28 includes spacing between each individual bristle or projection 28).
In regards to claim 4, Farrell teaches the apparatus of claim 1. Farrell teaches in Figure 1 that the depth of said occlusal plane (base portion 11), intended as distance between the inner arch (inner flange portion 13) and outer arch (outer flange portion 12) is such that it allows the use of the device (oral appliance 10) also by subjects using teeth aligners (a user of teeth aligners is capable of positioning their dentition on the base portion 11 and within the channel defined by base portion 11, inner flange portion 13 and outer flange portion 12 depending on the size/shape of the individual user’s dentition).
In regards to claim 6, Farrell teaches the apparatus of claim 1. Farrell teaches in Figure 2 that the thickness of said occlusal plane (base portion 11), measured along the development (vertical axis extending through point 19) of the middle arch (base portion 11), is constant (Figure 2 teaches the base portion 11 having a single, constant thickness at the position of the vertical axis extending through point 19).
In regards to claim 7, Farrell teaches the apparatus of claims 1 and 6. Farrell teaches in column 4, lines 34-35 that said thickness is between 4 and 6 mm (column 4, lines 34-35 teaches “a maximum thickness of approximately 4 mm. at the regions 19”).
In regards to claim 8, Farrell teaches the apparatus of claim 1. Farrell teaches in Figure 2 and column 4, lines 34-38 that the thickness of said occlusal plane (base portion 11) measured along the development of the middle arch (base portion 11) is greater in the front portion (regions 19) of the device (oral appliance 10) than in (column 4, lines 34-38 teaches the base portion 11 having “a maximum thickness of approximately 4 mm. at the regions 19 towards the trailing ends 20 of the appliance 10 and then reduces to a thickness of approximately 3 mm. at the trailing ends 20”) the end portion (trailing ends 20).
In regards to claim 9, Farrell teaches the apparatus of claims 1 and 8. Farrell teaches in Figure 2 and column 4, lines 32-35 said occlusal plane (base portion 11) has a constant thickness (single thickness) in the portion (vertical axis extending immediately behind the upper canine tooth in use) at the rear of the position of the upper canine tooth (Figure 2 teaches the base portion 11 having a single, constant thickness at the position of the vertical axis extending immediately behind the upper canine tooth in use), and an increasing thickness from the canine position (location(s) at which a user’s canine teeth would be positioned in use) to (Figure 2 teaches the thickness of the base portion increasing from the location(s) at which a user’s canine teeth would be positioned in use to the regions 19; column 4, lines 32-35 teaches “the base portion 11 has a thickness of approximately 2 mm. adjacent the leading end 18 of the appliance which increases to a maximum thickness of approximately 4 mm. at the regions 19”) the front portion of the device (regions 19).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell (US 5,259,762 A).
In regards to claim 5, Farrell teaches the apparatus of claims 1 and 4. Farrell teaches in Figure 1 that the shape of the device (oral appliance 10) is also such that the middle (anterior apex of oral appliance 10) is the point where the depth of the occlusal plane (base portion 11) is the lowest one (as highlighted in the annotated copy of Figure 1 provided below).
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Farrell does not teach that said depth of said occlusal plane, measured inside said inner arch and said outer arch at the middle of the device, is greater than 5,5 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 said depth of said occlusal plane, measured inside said inner arch and said outer arch at the middle of the device, is greater than 5,5 mm, since it has been held that where the general conditions of a claim are disclosed in the 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 depth of said occlusal plane, measured inside said inner arch and said outer arch at the middle of the device could be modified in order to most appropriately and/or comfortably accommodate the dentition of each individual user.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell (US 5,259,762 A) in view of Sue (US 6,295,988 B1).
In regards to claim 10, Farrell teaches the apparatus of claim 1. Farrell does not teach a plurality of through holes arranged along the development of said occlusal plane.
However, Sue teaches in Figures 1 and 2 and column 3, lines 53-55 an analogous device with a plurality of through holes (drainage holes 18) arranged along the development of (as shown in Figures 1 and 2; column 3, lines 53-55 teaches “platform 14 has at least one, and in the depiction of FIG. 1, two, drainage holes 18”) said occlusal plane (platform 14).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the occlusal plane of Farrell to include a plurality of through holes arranged along the development of said occlusal plane as taught by Sue because this element is known to function “for avoiding accumulation of saliva on platform 14,” as Sue teaches in column 3, lines 53-55.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thynne, JR. (US 2016/0193074 A1)
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 12/31/2025