DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments of claims 1, 3, 12-14, 16-18, and 20-21 are acknowledged by the Examiner.
Applicant’s addition of new claims 22-31 are acknowledged by the Examiner.
Applicant’s amendments of claims 1 and 20 have overcome the specification objections. Therefore, the previous specification objections are withdrawn.
Applicant’s amendments of claims 1, 3, 13-14, 16-18, and 20-21 have overcome the claim objections. Therefore, the previous claim objections are withdrawn.
Applicant’s amendments to claims 1, 3, 18, 20, and 21 has overcome the previous rejections under 35 U.S.C. 112(a). Therefore, the rejections under 35 U.S.C. 112(a) are withdrawn.
Applicant’s amendments to claims 1, 12-14, 16-18, 20, and 21 has overcome most of the previous rejections under 35 U.S.C. 112(b). Therefore, the rejections under 35 U.S.C. 112(b) are updated below.
Claims 1, 3-5, 7-8, 10-14, 16-18 and 20-31 are pending in the current application.
Response to Arguments
In regards to Applicant’s arguments regarding the drawing objections with respect to new claim 23. Examiner respectfully disagrees. Applicant’s drawings submitted on 11/04/2025 appear to be arbitrarily drawn with respect to the drawing objections, and neglect to include structures previously seen in the originally filed drawings (See example below). Thus, the drawing objections will be maintained, and updated to reflect the new matter.
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Applicant’s arguments with regards to the specification objections are moot in view of the claim amendments.
Applicant’s arguments with regards to most of the rejections made under 35 U.S.C. 112(a) are moot in view of the claim amendments.
With regards to Applicant’s arguments regarding the allowable subject matter: Applicant has amended claims 1 and 20 by removing the previously indicated allowable subject matter of “Identifying a problem location comprising the patient's infected, abscessed, diseased, or damaged tooth:
Ascertaining whether the problem location is on a left side of the patient's mouth or on a right side of the patient's mouth;
Identifying an opposite side that is opposite the problem location side, such that if the problem location is on the left side, the opposite side is on the right side, and if the problem location is on the right side, the opposite side is on the left side;
preventing contact between the teeth on the problem location side by creating and inserting a blocking device for the opposite side according to the following steps”. Thus, the allowability of claims 1 and 20 are withdrawn, and the claims are rejected as will be discussed below. Additionally the new claims are also rejected as will be discussed below.
The Affidavits of Bruce Consentino, Eugene Casagrande, Jill Hanna, and Jeremy Tanner under 37 CFR 1.132 filed 11/04/2025 are insufficient because: the current claims do not merely restate in different words what the previous set of claims recited, and a POSITA would not understand that the replacement drawings are merely different views due to the reasons discussed above.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the outer anterior wall, inner posterior wall, and base portion in cross section forma "U" shape” as recited in claim 23 must be shown or the feature(s) canceled from the claim(s).
No new matter should be entered.
Figures 1 AC, 1B’, 2AB are objected to for new matter situations as the new figures neglect to include structures previously seen in the originally filed drawings as discussed above.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not provide antecedent support for the limitations of “locating a problem location associated with the infected, abscessed, diseased or damaged tooth”, and “locating a non-affected side of the patient's mouth” as recited in claim 30.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 recites the limitation “once it the deformable thermoplastic material”. This limitation should be amended to remove “it”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30 and 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 30 recites the limitations “locating a problem location…locating a non-affected side of the patient’s mouth”. These limitations were not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, conducted the method as claimed. Therefore, the limitation is considered new matter.
Claim 31 is rejected under 35 U.S.C. 112(a) as being dependent from a rejected claim and therefore, contain the same offending limitations.
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, 3-5, 7-8, 10-14, 16-18, and 20-31 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 patient’s mouth” in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a mouth of the patient”.
Claim 12 recites the limitation “a bite block device formed by the method of claim 1”. This limitation is held to be unclear given claim 1 recites “a bite block device…is made according to steps”. Therefore, reciting a bite block formed by the method of claim 1. Thus, it is unclear as to if the bite block of claim 12 is the same as recited in claim 1, or a new bite block. For the purpose of examination, Examiner will interpret these bite blocks as being the same.
Claim 20 recites the limitation “the patient’s mouth” in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a mouth of the patient”.
Claim 20 recites the limitation “the following steps” in line 13. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 22 recites the limitation “the inside of the portion”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 24 recites the limitation “the patient’s mouth” in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a mouth of the patient”.
Claim 26 recites the limitation “the outer posterior wall” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the inner posterior wall”.
Claim 28 recites the limitation “the patient’s mouth” in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a mouth of the patient”.
Claim 29 recites the limitation “the outer posterior wall” in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the inner posterior wall”.
Claim 29 recites the limitation “the channel portion” in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the upper channel portion”.
Claim 30 recites the limitation “the patient’s mouth” in line 6. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a mouth of the patient”.
Claim 31 recites the limitation “the outer wall” in line 10. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the outer anterior wall”.
Claims 3-5, 7-8, 10-11, 13-14, 16-18, 21, 23, 25, and 27 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim and therefore contain the same offending limitations.
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, 4-5, 8, 10-11, and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan et al. (US 2006/0237020 A1) (hereinafter Morgan) in view of “Cracked Teeth” by Fort Worth Endodontics published 08/07/2016 (hereinafter Cracked Teeth), Spainhower (US 2011/0290261 A1) and Kamradt (US 2013/0247922 A1).
In regards to claim 1, Morgan discloses A method for temporarily treating a patient having an infected, diseased or damaged tooth (see [0040] in reference to the device comprising medication, and [0041] in reference to delivering said medication to a tooth; medication being applied to a tooth means that either the tooth is infected or diseased, and requires medication to be applied; the device will not be applied forever and thus is considered a temporary treatment) that causes pain to the patient when the patient’s infected, diseased or damaged tooth is contacted against one or more other teeth of the patient and temporarily preventing such painful contact (14 prevents pain by preventing occlusion (i.e. tooth on tooth contact) of an affected dentition against a non-affected dentition by being placed over the user’s infected tooth as discussed above and providing a layer between the patient’s teeth thereby, preventing painful contact between teeth; see figure 32), comprising:
placing a bite block device (14; see [0037]; see figure 16) in the patient’s mouth (see figures 32-33) for preventing occlusion of an affected dentition against a non-affected dentition, wherein the affected dentition comprises the patient’s infected, abscessed, diseased, or damaged tooth (see discussion above with respect to 14 preventing occlusion) on a left side of the patient’s mouth or on a right side of the patient’s mouth,
wherein the bite block device (14) is made according the steps comprising:
selecting a predetermined volume of deformable thermoplastic material (see [0074] selecting a thermoplastic is interpreted as selecting a predetermined volume of thermoplastic material) adapted for insertion into the patient’s mouth (see figures 32-33);
heating the predetermined volume of deformable thermoplastic material for a first period of time (see [0078] in reference to utilizing thermoplastic that is moldable at 95 degrees of 180 degrees, thus the predetermined volume of 14 is heated for a predetermined amount of time to reach said temperatures) sufficient to allow the deformable thermoplastic material to reach deformable plasticity (see [0078]);
wherein, once the deformable thermoplastic material has been inserted into the patient’s mouth for a second period of time it takes the predetermined volume of deformable material to become plastically rigid about a portion, but not an entirety of the patient’s maxillary teeth (see [0078]) such that the deformable thermoplastic material comprises:
an upper channel (30; see [0034]; see figure 19) configured to follow and engage the portion of the patient's maxillary teeth (see figure 17), wherein the upper channel (30) substantially surrounds the portion of the patient’s maxillary teeth (see [0038] in reference to the walls extending from left and right sides of 30, thereby the combination of 30 and the walls surrounds the patient’s maxillary teeth), the upper channel (30) further comprised of an inner posterior wall (90 of the upper channel; see [0037]; see figures 5 and 7) and an outer anterior wall (92 of the upper channel; see [0040]; see figure 7) adapted to contact at least a portion of the patient’s gums (See figure 32) extending from opposite lateral sides of a lower channel surface (see figure 7 that 90 and 92 extend from inner and outer surfaces of a lower channel surface);
a base portion (40; see [0034]; see figure 19) having a bottom surface consisting of a plurality of pre-molded ridges (See figure 3), the bottom surface (bottom surface defined by 40) configured to follow and engage at least a portion of the patient's mandibular teeth opposite the portion of the patient's maxillary teeth (see figure 32),
wherein the portions of the patient’s maxillary and mandibular teeth are engaged onto the deformable thermoplastic material (See figure 32) a gap (20; see [0034]; see figure 19) is provided between portions of the patient’s maxillary and mandibular teeth not contacting the deformable thermoplastic material (see figure 32 that 30 is separated from 40 via 20 (the gap), see also that 20 separates the user’s upper and lower teeth from one another on one side of the user’s mouth, therefore, a corresponding gap would also be made on the opposite side of the user’s mouth not engaging the thermoplastic material in response to 20 preventing occlusion).
With regards to the preamble limitations of “a method for helping to reduce opioid use”. When reading the preamble in the context of the entire claim, the recitation “a method for helping to reduce opioid use” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Morgan does not explicitly disclose placing a bite block on an opposite side of the patient’s mouth that is opposite the side of the affected dentition, such that if the affected dentition is on the left side, the opposite side is on the right side, and if the affected dentition is on the right side, the opposite side is on the left side,
placing the predetermined volume of deformable thermoplastic material in a predetermined volume of heated water for a first period of time;
removing the deformable thermoplastic material from the predetermined volume of heated water once the deformable thermoplastic material reaches a deformable state;
cooling the deformable thermoplastic material;
inserting the deformable thermoplastic material in the mouth of the patient once the deformable thermoplastic material has cooled to a predetermined degree; and
an outer portion interconnected to at least a portion of an outer surface of the outer wall, wherein the outer portion is made of a material that is stiffer than the deformable thermoplastic material.
However, Cracked Teeth teaches that chewing (or putting pressure) on an injured tooth can cause movement of the cracked pieces of your tooth which can result in sharp pain and further damage to the tooth and the pulp which will cause the tooth will consistently hurt, even when you are not chewing (see pg 2).
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 placement of the bite block device as disclosed by Morgan, and to have positioned the bite block device on an opposite side of the patient’s mouth that is opposite the side of the affected dentition such that the bite block device does not engage the affected dentition and will not cause movement of the cracked pieces of the injured tooth which can result in sharp pain for the user and further damage to the tooth and the pulp as taught by Cracked teeth in order to have provided an improved method for temporarily treating a patient having an infected, diseased or damaged tooth that would add the benefit of ensuring the bite block device would not cause further damage to the tooth and the pulp by contacting the user’s tooth which will cause the tooth will consistently hurt, even when the user is not chewing (see pg 2). Furthermore, such a modification in placement of the bite block device of Morgan is held to be obvious to a person of ordinary skill in the art to place the bite block device on a side opposite the affected dentition because Applicant has not placed criticality on the method, and contrarily states in their specification [0067] that: “the Bite Block may be placed over the problematic tooth” thereby contemplating an embodiment in which the claimed device is placed over the affected dentition, evidencing that the claimed placement is optional and would be obvious to one of ordinary skill in the art.
Morgan as now modified by Cracked Teeth does not explicitly disclose,
placing the predetermined volume of deformable thermoplastic material in a predetermined volume of heated water for a first period of time;
removing the deformable thermoplastic material from the predetermined volume of heated water once the deformable thermoplastic material reaches a deformable state;
cooling the deformable thermoplastic material;
inserting the deformable thermoplastic material in the mouth of the patient once the deformable thermoplastic material has cooled to a predetermined degree; and
an outer portion interconnected to at least a portion of an outer surface of the outer wall, wherein the outer portion is made of a material that is stiffer than the deformable thermoplastic material.
However, Spainhower teaches an analogous volume of deformable thermoplastic material (10; see [0020]; see figure 1), wherein the formation of the volume of deformable thermoplastic material (10) comprises the steps of: disclose placing the predetermined volume of deformable thermoplastic material (10) in a predetermined volume of heated water for a first period of time (see [0047] heating the mouth guard 10 (e.g., in boiling water, etc.) to a sufficient temperature (e.g., 100.degree. C., etc.) and for a sufficient period of time (e.g., about 30 seconds, etc.) to soften the same);
removing the deformable thermoplastic material (10) from the predetermined volume of heated water once the deformable thermoplastic material (10) reaches a deformable state (see [0047] in reference to allowing 10 to cool, thus taking the device from the boiling water it was being heated in);
cooling the deformable thermoplastic material (10; see [0047] the mouth guard 10 may be allowed to cool somewhat (e.g., for about five or ten seconds, etc.));
inserting the deformable thermoplastic material (10) in the mouth of the patient once the deformable thermoplastic material has cooled to a predetermined degree (see [0047] may be allowed to cool somewhat (e.g., for about five or ten seconds, etc.) before being placed within the subject's mouth M) for the purpose of conforming to all features of the patient’s mouth (see [0047]).
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 method of forming the deformable thermoplastic material as disclosed by Morgan as now modified by Cracked Teeth by forming it utilizing the boil and bite method and the associated steps as taught by Spainhower in order to have provided an improved method that would add the benefit of allowing the deformable thermoplastic to conform to all features of the patient’s mouth (see [0047]) in a timely and safe manner.
Morgan as now modified by Cracked Teeth, and Spainhower still does not disclose an outer portion interconnected to at least a portion of an outer surface of the outer wall, wherein the outer portion is made of a material that is stiffer than the deformable thermoplastic material.
However, Kamradt teaches an analogous oral device (2; see [0015]; see figure 1) formed of a soft material (see [0016] in reference to 2 being a soft rubber material) which comprises an outer wall and an outer surface of said outer wall (see figure 2 that 2 comprises an outer wall with an outer surface);
further comprising an outer portion (1; see [0016]; see figure 2) interconnected to at least a portion of an outer surface of the outer wall (see figure 3), wherein the outer portion (1) is made of a material that is stiffer than the soft material (see [0016] in reference to 1 being rigid, and 2 being soft, thus 1 is considered “stiffer” than 2) for the purpose of providing support to the inner, soft, flexible members, and for providing a means for absorbing energy (see [0016-0017]).
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 outer surface of the outer wall of the deformable thermoplastic material as disclosed by Morgan as now modified by Cracked Teeth, and Spainhower by including the rigid outer portion connected to an outer surface of the outer wall as taught by Kamradt in order to have provided an improved volume of deformable thermoplastic material which would add the benefits of providing support to the inner, soft, flexible members, and for providing a means for absorbing energy (see [0016-0017]) thereby increasing the absorptive capabilities of the oral device which could further damage a user’s infected, diseased, or damaged tooth.
In regards to claim 4, Morgan as now modified by Cracked Teeth, Spainhower, and Kamradt, discloses the invention as discussed above.
Morgan as now modified by Spainhower further discloses further comprising holding the deformable thermoplastic material in a desired place in the patient’s mouth to ensure the deformable thermoplastic material does not move within the patient’s mouth of during the cooling (see Spainhower [0047] in reference to the user biting down on 10, and utilizing their fingers to press the device into their dental arch, this is considered to be holding in (via biting and pressing) the device into the desired place to assure the proper fit is achieved).
In regards to claim 5, Morgan as now modified by Cracked Teeth, Spainhower and Kamradt discloses the invention as discussed above.
Morgan further discloses wherein gap (20) between the patient's maxillary and mandibular teeth is in the range of about 4 mm to about 7 mm (see [0055] in reference to 20 having a thickness of 4mm-12mm; thus the gap created by 20 between the maxillary and mandibular teeth of the patient is 4mm-12mm; 12mm is considered to be “about” 7 mm due to the miniscule difference in the two sizes).
In regards to claim 8, Morgan as now modified by Cracked Teeth, Spainhower and Kamradt discloses the invention as discussed above.
Morgan further discloses wherein the plurality of pre-molded ridges are contoured to match the surfaces the patient’s mandibular teeth (see [0078] in reference to molding the mouth guard to the user’s upper and lower teeth, thus the plurality of pre-molded ridges are contoured by molding during the forming of the device to match the surfaces of the patient’s mandibular teeth).
In regards to claim 10, Morgan as now modified by Cracked Teeth, Spainhower and Kamradt discloses the invention as discussed above.
Morgan further discloses wherein the deformable thermoplastic material is formed by the patient (see [0078] in reference to molding the mouth guard to the patient’s teeth, thus, the patient’s teeth, and therefore the patient forms the deformable thermoplastic material).
In regards to claim 11, Morgan as now modified by Cracked Teeth, Spainhower and Kamradt discloses the invention as discussed above.
Morgan further discloses wherein the deformable thermoplastic material is formed by a medical or dental professional or assistant (see [0078] in reference to forming the mouth guard by being “fitted to dental models of the person’s teeth”; these dental models as discussed are made by dental professionals or dental assistants, and therefore if the mouth guard is formed by molding to dental models, the device is directly formed by a dental professional working with the model, or indirectly formed by a dental professional who provides the user with said model).
In regards to claim 22, Morgan as now modified by Cracked Teeth, Spainhower and Kamradt discloses the invention as discussed above.
Morgan further discloses wherein the inner posterior wall (90 of the upper channel) is configured to be positioned on the inside of the portion consisting of the patient’s upper teeth and gums (see figure 17 that 90 of the upper channel is intended to be placed on a lingual side of the user’s dentition), and further consists of wherein the inner posterior wall extends upward from the channel portion (30; see figure 16)
In regards to claim 23, Morgan as now modified by Cracked Teeth, Spainhower and Kamradt discloses the invention as discussed above.
Morgan further discloses wherein the outer anterior wall (92 of the upper channel), inner posterior wall (90 of the upper channel) and base portion (40) in cross section form a “U” shape (See figure 19).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan in view of Cracked Teeth, Spainhower, and Kamradt as applied to claim 1 above, and further in view of Barnes SR. et al. (US 2016/0107067 A1) (hereinafter Barnes).
In regards to claim 3, Morgan as now modified by Cracked Teeth, Spainhower and Kamradt discloses the invention as discussed above.
Morgan as now modified by Cracked Teeth, Spainhower, and Kamradt does not disclose further comprising applying an adhesive material to the upper channel of the deformable thermoplastic material.
However, Barnes teaches an analogous oral device (mouth piece; see [0013]; see figure 1) comprising the step of applying an adhesive material (adhesive; see [0013]) to the upper channel of the deformable thermoplastic material (see figure 1) for the purpose of minimizing discomfort for the user (see [0014]) and bonding the mouth guard to the user’s teeth (see [0019]).
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 method of applying the thermoplastic material to the user’s teeth as disclosed by Morgan as now modified by Cracked Teeth, Spainhower, and Kamradt and to have added the step of applying adhesive to the upper channel of the mouth guard as taught by Barnes in order to have provided an improved method of applying the oral device that would add the benefit of minimizing discomfort for the user (see [0014]) and bonding the mouth guard to the user’s teeth (see [0019]).
Claim(s) 7, 12-14, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan in view of Cracked Teeth, Spainhower, and Kamradt as applied to claim 1 above, and further in view of Fischer et al. (US 6,716,029 B2).
In regards to claim 7, Morgan as now modified by Cracked Teeth, Spainhower, and Kamradt discloses the invention as discussed above.
Morgan as now modified by Cracked Teeth, Spainhower, and Kamradt does not disclose wherein the deformable thermoplastic material is comprised of at least a polypropylene.
However, Fischer teaches an analogous oral device (90; see [Col 12 ln 28-40]; see figures 8a-8d) comprising an analogous thermoplastic material (94; see [Col 12 ln 28-40]; see figure 8c) wherein the deformable thermoplastic material (94) is comprised of at least a polypropylene (see [Col 11 ln 63-Col 12 ln 5]) for the purpose of providing a material which was plastically deformable at a temperature greater than body temperature, while not being plastically deformable at body temperature (see [Col 11 ln 63-Col 12 ln 5]).
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 material of the deformable thermoplastic material as disclosed by Morgan as now modified by Cracked Teeth, Spainhower, and Kamradt and to have formed the deformable thermoplastic material from polypropylene as taught by Fischer in order to have provided an improved deformable thermoplastic material that would add the benefit of providing a material which was plastically deformable at a temperature greater than body temperature, while not being plastically deformable at body temperature (see [Col 11 ln 63-Col 12 ln 5]).
Furthermore, such a modification to utilize polypropylene for the thermoplastic material is held to be an obvious modification based on Morgan’s disclosure that states the use of ethylene vinyl alcohol (EVA; see [0078]), Fischer teaching the use of either EVA or polypropylene (see [Col 11 ln 63-Col 12 ln 5]) for the thermoplastic material, and Applicant’s specification [0046] discussing the use of polypropylene and EVA as acceptable thermoplastics to use in the device.
In regards to claim 12, Morgan as now modified by Cracked Teeth, Spainhower, and Kamradt discloses the invention as discussed above.
Morgan further discloses A bite block device formed by the method of claim 1 comprising (see discussion of claim 1 above):
wherein the gap (20) is at least 4 mm (see [0055] in reference to 20 having a thickness of 4mm-12mm; thus the gap created by 20 between the first and second portion (upper and lower portions) of the patient’s teeth is 4mm-12mm);
Morgan as now modified by Cracked Teeth, Spainhower, and Kamradt does not disclose wherein the deformable thermoplastic material is comprised of at least polypropylene.
However, Fischer teaches an analogous oral device (90; see [Col 12 ln 28-40]; see figures 8a-8d) comprising an analogous thermoplastic material (94; see [Col 12 ln 28-40]; see figure 8c) wherein the deformable thermoplastic material (94) is comprised of at least a polypropylene (see [Col 11 ln 63-Col 12 ln 5]) for the purpose of providing a material which was plastically deformable at a temperature greater than body temperature, while not being plastically deformable at body temperature (see [Col 11 ln 63-Col 12 ln 5]).
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 material of the deformable thermoplastic material as disclosed by Morgan as now modified by Cracked Teeth, Spainhower and to have formed the deformable thermoplastic material from polypropylene as taught by Fischer in order to have provided an improved deformable thermoplastic material that would add the benefit of providing a material which was plastically deformable at a temperature greater than body temperature, while not being plastically deformable at body temperature (see [Col 11 ln 63-Col 12 ln 5]).
Furthermore, such a modification to utilize polypropylene for the thermoplastic material is held to be an obvious modification based on Morgan’s disclosure that states the use of ethylene vinyl alcohol (EVA; see [0078]), Fischer teaching the use of either EVA or polypropylene (see [Col 11 ln 63-Col 12 ln 5]) for the thermoplastic material, and Applicant’s specification [0046] discussing the use of polypropylene and EVA as acceptable thermoplastics to use in the device.
In regards to claim 13, Morgan as now modified by Cracked Teeth, Spainhower, Kamradt, and Fischer discloses the invention as discussed above.
Morgan further discloses wherein no greater than 3/4 of the patient’s maxillary and mandibular teeth are engaged (see [0039] in reference to 12 engaging one side of the user’s jaw to receive substantially one side of the user’s upper/lower teeth (or ½ of the user’s teeth); see figures 2 and 17 that 12 and 14 have substantially the same shape, and therefore, 14 is considered to also engage substantially 1/2 of the user’s dental arch).
In regards to claim 14, Morgan as now modified by Cracked Teeth, Spainhower, Kamradt and Fischer discloses the invention as discussed above.
Morgan further discloses wherein the gap (20) is in the range of 5-7 mm (see [0055] in reference to 20 having a thickness of 4mm-12mm; thus the gap created by 20 between the first and second portion (upper and lower portions) of the patient’s teeth is in the range 5mm-7mm).
In regards to claim 16, Morgan as now modified by Cracked Teeth, Spainhower, Kamradt, and Fischer discloses the invention as discussed above.
Morgan further discloses wherein the deformable thermoplastic material is formed by the patient (see [0078] in reference to molding the mouth guard to the patient’s teeth, thus, the patient’s teeth, and therefore the patient forms the deformable thermoplastic material).
In regards to claim 17, Morgan as now modified by Cracked Teeth, Spainhower, Kamradt and Fischer discloses the invention as discussed above.
Morgan further discloses wherein the deformable thermoplastic material is formed by a dental technician or dental assistant (see [0078] in reference to forming the mouth guard by being “fitted to dental models of the person’s teeth”; these dental models as discussed are made by dental professionals or dental assistants, and therefore if the mouth guard is formed by molding to dental models, the device is directly formed by a dental technician or assistant working with the model, or indirectly formed by a dental technician or assistant who provides the user with said model).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan in view of Cracked Teeth, Spainhower, Kamradt, and Fischer as applied to claim 12 above, and further in view of Barnes.
In regards to claim 18, Morgan as now modified by Cracked Teeth, Spainhower, Kamradt, and Fischer discloses the invention as discussed above.
Morgan as now modified by Cracked Teeth, Spainhower, Kamradt, and Fischer does not disclose wherein an adhesive material is applied to the channel of the deformable thermoplastic material.
However, Barnes teaches an analogous oral device (mouth piece; see [0013]; see figure 1) comprising the step of an adhesive material (adhesive; see [0013]) is applied to the channel of the deformable thermoplastic material (see figure 1) for the purpose of minimizing discomfort for the user (see [0014]) and bonding the mouth guard to the user’s teeth (see [0019]).
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 method of applying the thermoplastic material to the user’s teeth as disclosed by Morgan as now modified by Cracked Teeth, Spainhower, Kamradt, and Fischer and to have added the step of applying adhesive to the inner channel of the mouth guard as taught by Barnes in order to have provided an improved method of applying the oral device that would add the benefit of minimizing discomfort for the user (see [0014]) and bonding the mouth guard to the user’s teeth (see [0019]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan in view of Cracked Teeth, Spainhower, Kamradt, and Fischer.
In regards to claim 20, Morgan discloses A method for temporarily treating a patient having an infected, diseased or damaged tooth (see [0040] in reference to the device comprising medication, and [0041] in reference to delivering said medication to a tooth; medication being applied to a tooth means that either the tooth is infected or diseased, and requires medication to be applied; the device will not be applied forever and thus is considered a temporary treatment) that causes pain to the patient when the patient’s infected, diseased or damaged tooth is contacted against one or more other teeth of the patient and temporarily preventing such painful contact (14 prevents pain by preventing occlusion (i.e. tooth on tooth contact) of an affected dentition against a non-affected dentition by being placed over the user’s infected tooth as discussed above and providing a layer between the patient’s teeth thereby, preventing painful contact between teeth; see figure 32), comprising:
placing a bite block device (14; see [0037]; see figure 16) in the patient’s mouth (see figures 32-33) for preventing occlusion of an affected dentition comprising the patient’s infected, abscessed, diseased, or damaged tooth (see discussion above with respect to 14 preventing occlusion) on a left side of the patient’s mouth or on a right side of the patient’s mouth,
wherein the bite block device (14) is made according the steps comprising:
selecting a predetermined volume of deformable thermoplastic material (see [0074] selecting a thermoplastic is interpreted as selecting a predetermined volume of thermoplastic material) adapted for insertion into the patient’s mouth (see figures 32-33);
heating the predetermined volume of deformable thermoplastic material for a first period of time (see [0078] in reference to utilizing thermoplastic that is moldable at 95 degrees of 180 degrees, thus the predetermined volume of 14 is heated for a predetermined amount of time to reach said temperatures) sufficient to allow the deformable thermoplastic material to reach deformable plasticity (see [0078]);
wherein, once the deformable thermoplastic material has been inserted into the patient’s mouth for a second period of time it takes the predetermined volume of deformable material to become plastically rigid about a portion of the patient’s maxillary teeth (see [0078]) such that the deformable thermoplastic material comprises:
a channel (30; see [0034]; see figure 19) configured to follow and engage the portion of the patient's maxillary teeth (see figure 17), wherein the channel (30) substantially surrounds the portion of the patient’s maxillary teeth (see [0038] in reference to the walls extending from left and right sides of 30, thereby the combination of 30 and the walls surrounds the patient’s maxillary teeth), the channel (30) further comprised of an inner wall (90 of the upper channel; see [0037]; see figures 5 and 7) and an outer wall (92 of the upper channel; see [0040]; see figure 7) adapted to contact at least a portion of the patient’s gums (See figure 32) extending from opposite lateral sides of a lower channel surface (see figure 7 that 90 and 92 extend from inner and outer surfaces of a lower channel surface);
a base portion (40; see [0034]; see figure 19) having a bottom surface consisting of a plurality of pre-molded ridges (See figure 3), the bottom surface (bottom surface defined by 40) configured to follow and engage at least a portion of the patient's mandibular teeth opposite the portion of the patient's maxillary teeth (see figure 32),
wherein when the portions of the patient’s maxillary and mandibular teeth are engaged onto the deformable thermoplastic material (See figure 32) a gap (20; see [0034]; see figure 19) is provided between portions of the patient’s maxillary and mandibular teeth on the side of the affected dentition (see figure 32 that 30 is separated from 40 via 20 (the gap), see also that 20 separates the user’s upper and lower teeth from one another on one side of the user’s mouth, therefore, a corresponding gap is made between upper and lower teeth of the affected dentition);
wherein gap (20) between the patient's maxillary and mandibular teeth is in the range of about 4 mm to about 7 mm (see [0055] in reference to 20 having a thickness of 4mm-12mm; thus the gap created by 20 between the maxillary and mandibular teeth of the patient is 4mm-12mm; 12mm is considered to be “about” 7 mm due to the miniscule difference in the two sizes);
wherein the plurality of pre-molded ridges are contoured to match the surfaces the patient’s mandibular teeth (see [0078] in reference to molding the mouth guard to the user’s upper and lower teeth, thus the plurality of pre-molded ridges are contoured by molding during the forming of the device to match the surfaces of the patient’s mandibular teeth); and
wherein no greater than 3/4 of the patient’s maxillary and mandibular teeth are engaged (see [0039] in reference to 12 engaging one side of the user’s jaw to receive substantially one side of the user’s upper/lower teeth (or ½ of the user’s teeth); see figures 2 and 17 that 12 and 14 have substantially the same shape, and therefore, 14 is considered to also engage substantially 1/2 of the user’s dental arch).
With regards to the preamble limitations of “a method for helping to reduce opioid use”. When reading the preamble in the context of the entire claim, the recitation “a method for helping to reduce opioid use” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Morgan does not explicitly disclose placing a bite block on an opposite side of the patient’s mouth that is opposite the side of the affected dentition, such that if the affected dentition is on the left side, the opposite side is on the right side, and if the affected dentition is on the right side, the opposite side is on the left side,
placing the predetermined volume of deformable thermoplastic material in a predetermined volume of heated water for a first period of time;
removing the deformable thermoplastic material from the predetermined volume of heated water once the deformable thermoplastic material reaches a deformable state;
cooling the deformable thermoplastic material;
inserting the deformable thermoplastic material in the mouth of the patient once the deformable thermoplastic material has cooled to a predetermined degree;
an outer portion interconnected to at least a portion of an outer surface of the outer wall, wherein the outer portion is made of a material that is stiffer than the deformable thermoplastic material,
further comprising holding the deformable thermoplastic material in a desired place in the patient’s mouth to ensure the deformable thermoplastic material does not move within the patient’s mouth of during the cooling,
wherein the deformable thermoplastic material is comprised of at least a polypropylene.
However, Cracked Teeth teaches that chewing (or putting pressure) on an injured tooth can cause movement of the cracked pieces of your tooth which can result in sharp pain and further damage to the tooth and the pulp which will cause the tooth will consistently hurt, even when you are not chewing (see pg 2).
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 placement of the bite block device as disclosed by Morgan, and to have positioned the bite block device on an opposite side of the patient’s mouth that is opposite the side of the affected dentition such that the bite block device does not engage the affected dentition and will not cause movement of the cracked pieces of the injured tooth which can result in sharp pain for the user and further damage to the tooth and the pulp as taught by Cracked teeth in order to have provided an improved method for temporarily treating a patient having an infected, diseased or damaged tooth that would add the benefit of ensuring the bite block device would not cause further damage to the tooth and the pulp by contacting the user’s tooth which will cause the tooth will consistently hurt, even when the user is not chewing (see pg 2). Furthermore, such a modification in placement of the bite block device of Morgan is held to be obvious to a person of ordinary skill in the art to place the bite block device on a side opposite the affected dentition because Applicant has not placed criticality on the method, and contrarily states in their specification [0067] that: “the Bite Block may be placed over the problematic tooth” thereby contemplating an embodiment in which the claimed device is placed over the affected dentition, evidencing that the claimed placement is optional and would be obvious to one of ordinary skill in the art.
Morgan as now modified by Cracked Teeth does not explicitly disclose,
placing the predetermined volume of deformable thermoplastic material in a predetermined volume of heated water for a first period of time;
removing the deformable thermoplastic material from the predetermined volume of heated water once the deformable thermoplastic material reaches a deformable state;
cooling the deformable thermoplastic material;
inserting the deformable thermoplastic material in the mouth of the patient once it the