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 .
Information Disclosure Statement
1. The information disclosure statement (IDS) submitted on 08/30/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, this submission of the information disclosure statement is being considered by the examiner.
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 “fiducial marks” in claims 1 and 11; “titration mechanism” in claim 6; and “control screw type, mechanical hinge, strap, post, jack screw, or microtitration” in claim 7; and “accessory” in claims 8-10, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Objections
Claims 1-10 are objected to because of the following informalities:
In claim 1, line 3 rephrase “an MAD” to read --the mandibular advancement device (MAD)--. Also, in claim 4, line 2; claim 11, line 3; and claim 12, line 2 rephrase “the MAD” to read --the mandibular advancement device (MAD)--.
In claims 1-10, rephrase “The splint” to read --The asymmetrical splint-- and “the splint” to read --the asymmetrical splint-, respectively.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “titration mechanism” in claims 6 and 12; and “accessory” in claims 8 and 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Terms such as “mechanism” that are functionally described are generic placeholder for the phrase “means for”. For examination purposes, “titration mechanism for being used” in claims 6 and 12 is interpreted as a control screw type, such as jack screw; mechanical hinge, such as a Herbst device; strap; a post or fin; microtitration mechanism, and the like (Specification, Paragraph 27). For examination purposes, “accessory for being calculated” in claims 8 and 10 is interpreted as a fin or a mechanical hinge or ball clasp retention mechanism, a sensor, and the like (Specification, Paragraph 28).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3-5 and 9-10 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 3 recites the limitation "the data" in line 2. There is insufficient antecedent basis for this limitation in the claim. Rephrase "the data” to read --data--.
Claim 4 recites the limitation "the extent". There is insufficient antecedent basis for this limitation in the claim. Rephrase "the extent” to read –an extent--.
Claim 5 recites the limitation “the anterior-posterior direction" in line 2. There is insufficient antecedent basis for this limitation in the claim. Rephrase "the anterior-posterior direction” to read --an anterior-posterior direction--.
Claim 9 is indefinite for not defining the meets and bounds of the claims. The Markush claim does not provide a list of the accessories, so it appears to be an in-completed drafted claim. For examination purposes, the accessory is interpreted as --a fin, mechanical hinge, ball clasp retention mechanism, and a sensor--.
Regarding claim 10, the phrase "of like accessories" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). For examination purposes, rephrase “a pre-designed library of like accessories” to read --a pre-designed library of accessories--.
Double Patenting
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 12-13 of U.S. Patent No. 12102501.
Regarding claim 1 of the instant application, U.S. Patent No. 12102501 claim 1 discloses An asymmetrical splint for a mandibular advancement device (MAD) for use with a patient having an asymmetrical dentition, wherein the asymmetry of the splint complements the asymmetry of the dentition such that when the MAD is used to advance the mandible the mandible is advanced symmetrically, wherein the asymmetrical splint comprises an occlusal surface and fiducial markings scored into the occlusal surface, and wherein the fiducial markings compensate for the curvature of each side of each arch by being placed on the occlusal surface in a location mathematically calculated to account for a patient's asymmetrical dentition such that the fiducial markings mark an extent of a symmetrical advancement of the mandible by the mandibular advancement device (MAD) of the asymmetrical dentition,wherein the asymmetry of the splint is determined based on the following Equation (1) for each of the right and left sides of the splint:tangent line =parallel line - cos (tangent angle) ..........Equation (1) where, the tangent line is a line tangential to splint curvature at a point,the point is a point selected on the splint to which an adjustment mechanism of the MAD is to be attached,the parallel line is a line parallel to anteroposterior (A/P) axis, andthe tangent angle is the angle between the tangent line and the parallel line.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 1 of patent 12102501 lies in the fact that the patented claims include many more elements and is thus much more specific. Thus, the invention of claim 1 of patent 12102501 in effect a “species” of the “generic” invention of current application claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the current application is anticipated by claim 1 of patent (12102501), it is not patentably distinct from claim 1 of patent 12102501.
All of the limitations of claim 2 can be found in claim 2 of U.S. Patent No. 12102501.
All of the limitations of claim 3 can be found in claim 3 of U.S. Patent No. 12102501.
All of the limitations of claim 4 can be found in claim 4 of U.S. Patent No. 12102501.
All of the limitations of claim 5 can be found in claim 5 of U.S. Patent No. 12102501.
All of the limitations of claim 6 can be found in claim 6 of U.S. Patent No. 12102501.
Regarding claim 11 of the instant application, U.S. Patent No. 12102501 claim 1 discloses An asymmetrical splint for a mandibular advancement device (MAD) for use with a patient having an asymmetrical dentition, wherein the asymmetry of the splint complements the asymmetry of the dentition such that when the MAD is used to advance the mandible the mandible is advanced symmetrically, wherein the asymmetrical splint comprises an occlusal surface and fiducial markings scored into the occlusal surface, and wherein the fiducial markings compensate for the curvature of each side of each arch by being placed on the occlusal surface in a location mathematically calculated to account for a patient's asymmetrical dentition such that the fiducial markings mark an extent of a symmetrical advancement of the mandible by the mandibular advancement device (MAD) of the asymmetrical dentition,wherein the asymmetry of the splint is determined based on the following Equation (1) for each of the right and left sides of the splint:tangent line =parallel line - cos (tangent angle) ..........Equation (1) where, the tangent line is a line tangential to splint curvature at a point,the point is a point selected on the splint to which an adjustment mechanism of the MAD is to be attached,the parallel line is a line parallel to anteroposterior (A/P) axis, andthe tangent angle is the angle between the tangent line and the parallel line.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 11 of the current application and claim 1 of patent 12102501 lies in the fact that the patented claims include many more elements and is thus much more specific. Thus, the invention of claim 1 of patent 12102501 in effect a “species” of the “generic” invention of current application claim 11. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 11 of the current application is anticipated by claim 1 of patent (12102501), it is not patentably distinct from claim 1 of patent 12102501.
All of the limitations of claim 12 can be found in claim 12 of U.S. Patent No. 12102501.
This is a nonstatutory double patenting rejection.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 8-10, as best understood given by the 35 USC 112(b) above, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cam et al. (U.S. Patent Pub. No. 20160199216).
Regarding claim 1, Cam discloses an asymmetrical splint 2502,2504 (Paragraphs 141 -143 and Figure 25A), upper and lower shells 2502,2504 for accommodating a patient's jaw asymmetry) for a mandibular advancement device (MAD) 2500 (Paragraphs 141 -143 and Figure 25A) for use with a patient having an asymmetrical dentition, wherein the asymmetry of the splint 2502,2504 complements (Paragraphs 141 -143 and Figure 25A) the asymmetry of the dentition such that when the MAD 2500 is used to advance the mandible, the mandible is advanced symmetrically (Paragraphs 141 -143 and Figure 25A, asymmetry in MAD 2500 accommodates jaw asymmetry producing symmetric jaw advancement along the anterior-posterior axis).
Regarding claim 2, Cam discloses the invention as described above and further discloses wherein the asymmetry in the dentition is due to asymmetry in mandible, maxilla, or both (Paragraph 141, asymmetry in dentition is due to asymmetry between the upper and lower jaws).
Regarding claim 3, Cam discloses the invention as described above and further discloses wherein the asymmetry in the splint 2502,2504 is mathematically calculated based (Paragraph 142, mandibular advancement devices that are customized to the patient, the appliance design and fabrication methods described herein may involve obtaining measurement data of the patient's jaw anatomy and/or jaw kinematics while the patient is awake) on data obtained regarding the asymmetry of the dentition.
Regarding claim 8, Cam discloses the invention as described above and further discloses an accessory (Paragraphs 45-46, 52, 141 and 143 and Figure 25A, protrusion advancement structure of the appliance 2500; this is the structure as defined by the 35 USC 112f analysis above) mathematically calculated to be placed (Paragraph 143, advancement structures shaped and/or placed to accommodate asymmetries associated with the TMJ. Various methods can be used to measure the patient's specific jaw asymmetry, including but not limited to facebow measurements, bite registrations, and/or ultrasound) in a precise location to account for the dentition asymmetry such that the use of the accessory (Paragraphs 45-46, 52, 141 and 143 and Figure 25A, protrusion advancement structure of the appliance 2500) contributes to the symmetrical advancement (Paragraph 141 and Figure 25A) of the mandible.
Regarding claim 9, Cam discloses the invention as described above and further discloses wherein the accessory (Paragraphs 45-46, 52, 141 and 143 and Figure 25A, protrusion fin advancement structure of the appliance 2500) is selected as a fin.
Regarding claim 10, Cam discloses the invention as described above and further discloses wherein the accessory (Paragraph 118, advancement structure with one or more removable portions that can be added or removed from the appliance to produce a desired geometry, such that the advancement structure is selected from a pre-designed library of additional accessories) is selected from a pre-designed library of accessories.
Claims 4-5, as best understood given by the 35 USC 112(b) above, are rejected under 35 U.S.C. 103 as being unpatentable over Cam et al. (U.S. Patent Pub. No. 20160199216) in view of Callender (WO 2010087824 A1).
Regarding claim 4, Cam discloses the invention as described above and further discloses wherein the asymmetrical splint 2502,2504 comprises an occlusal surface (Paragraphs 77, 118, 141 and Figure 25A, occlusal surface having advancement structures) and fiducial marks (Paragraphs 77, 118, 141 and Figure 25A, appliance can include a mandibular advancement structure having removable portions on occlusal surfaces that can be used to alter the thickness and/or shape of the structure in order to achieve a desired amount of symmetrical movement for a given treatment stage. The structure can include markings indicating how much of the structure should be removed to achieve a desired amount of jaw advancement) scored into the occlusal surface, and wherein the fiducial markings (Paragraphs 77, 118, and 141) compensate for the curvature of each side of each arch by being placed on the occlusal surface in a location, the fiducial markings (Paragraphs 77, 118, and 141)for symmetrical advancement by the mandibular advancement device (MAD) of the asymmetrical dentition (Paragraphs 77, 118, and 141).
However, Cam fails to explicitly disclose the fiducial markings indicating an extent of mandibular protrusion subsequent to an adjustment to the MAD.
Callender teaches an analogous splint 30 (Page 11, lines 8-22 and Figure 3, aligner 30 formed of upper and lower sections 31,32 to help maintain proper positioning of the mandible in a forward position for treatment of sleep apnea and snoring) wherein analogous fiducial marks (Page 11, lines 8-22, a numbers of lines or other visual indicia can be placed on the upper and lower sections 31 , 32 of the aligner 30 to assist the healthcare provider in measuring how much adjustment has been made over the course of treatment. In particular, marks can be made on the side of the aligner to indicate how much adjustment has been made) indicate an extent of mandibular protrusion subsequent to an adjustment to the analogous mandibular advancement device (MAD) (Page 11, lines 8-22 and Figure 3).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the fiducial markings of the asymmetrical splint on a patient’s asymmetrical dentition of Cam, so that the fiducial markings also mark an extent of a symmetrical advancement by a MAD of the asymmetrical dentition, as taught by Callender, in order to provide an improved asymmetrical splint with enhanced additional fiducial markings functionality that are applied for marking an extent mandibular advancement for assisting healthcare providers in determining the amount of adjustment over a treatment period (Callender, Page 11, lines 8-22).
Regarding claim 5, the combination of Cam in view of Callender discloses the invention as described above and further discloses wherein the fiducial markings (Callender, Page 11, lines 18-26, numbers of lines or other visual indicia placed on the upper and lower sections 31 , 32 of the aligner 30 indicating mandibular advancement in anterior-posterior direction) are calculated to indicate the extent of a symmetrical mandibular advancement in an anterior-posterior direction.
13. Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cam et al. (U.S. Patent Pub. No. 20160199216), as applied to claim 1, in view of Palmisano (U.S. Patent No. 6604527).
Regarding claim 6, Cam discloses the invention as described above but fails to explicitly disclose wherein the splint is used with a titration mechanism.
Palmisano teaches an analogous splint (Col. 7, lines 47-63 and Figure 15a, lower plate 150 for engaging with an upper plate for providing mandibular advancement) that is used with a titration mechanism 158 (Col. 7, lines 47-63 and Figure 15a,, mandibular advancement block 154 with a jack screw mechanism 158 ; this is the structure as defined by the 35 USC 112f analysis above).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the mandibular advancement of the splint of Cam, so that mandibular advancement is performed with a titration mechanism, as taught by Palmisano, in order to provide an improved asymmetrical splint to control the degree of adjustment via the titration mechanism for desirable incremental adjustment determined by the clinician (Palmisano, Col. 7, lines 47-63)
Regarding claim 7, the combination of Cam in view of Palmisano discloses the invention as described above and further discloses wherein the titration mechanism (Palmisano, Col. 7, lines 47-63 and Figure 15a, jack screw 158) is selected as a jack screw.
14. Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cam et al. (U.S. Patent Pub. No. 20160199216) in view of Greenberg (U.S. Patent Pub. No. 20090113714) and in further view of Callender (WO 2010087824 A1) .
Regarding claim 11, Cam discloses an asymmetrical splint 2502,2504 (Paragraphs 141 -143 and Figure 25A), upper and lower shells 2502,2504 for accommodating a patient's jaw asymmetry) for a mandibular advancement device (MAD) 2500 (Paragraphs 141 -143 and Figure 25A) for use with a patient having an asymmetrical dentition, wherein the asymmetry of the splint 2502,2504 complements (Paragraphs 141 -143 and Figure 25A) the asymmetry of the dentition such that when the MAD 2500 is used to advance the mandible, the mandible is advanced symmetrically (Paragraphs 141 -143 and Figure 25A, asymmetry in MAD 2500 accommodates jaw asymmetry producing symmetric jaw advancement along the anterior-posterior axis), wherein the asymmetrical splint 2502,2504 comprises an occlusal surface (Paragraphs 77, 118, 141 and Figure 25A, occlusal surface having advancement structures) and comprising fiducial markings (Paragraphs 77, 118, 141 and Figure 25A, appliance can include a mandibular advancement structure having removable portions on occlusal surfaces that can be used to alter the thickness and/or shape of the structure in order to achieve a desired amount of symmetrical movement for a given treatment stage. The structure can include markings indicating how much of the structure should be removed to achieve a desired amount of jaw advancement) scored into the occlusal surface, and wherein the fiducial markings (Paragraphs 77, 118, and 141) compensate for the curvature of each side of each arch by being placed on the occlusal surface in a location, the fiducial markings (Paragraphs 77, 118, and 141)for symmetrical advancement by the mandibular advancement device (MAD) of the asymmetrical dentition (Paragraphs 77, 118, and 141).
However, Cam fails to explicitly disclose (1) wherein fiducial markings are mathematically calculated to be placed to account for a patient's asymmetrical dentition; (2) the fiducial markings mark an extent of a symmetrical advancement by an MAD of the asymmetrical dentition.
Greenberg teaches a similar orthodontic device (Paragraph 25, orthodontic aligner wherein the material preferably completely conforms to the entirety of each tooth crown of the negative impression. The orthodontic aligner can be placed and removed) wherein analogous fiducial markings (Paragraph 25, at least 6 fiducial markers are placed on the appliance at the buccal or lingual surfaces of the teeth at a known distance from the crowns. The fiducial markers are wires or other radio-opaque markers placed to outline the buccal, incisal, and lingual contours) are mathematically calculated (Paragraph 25, known distance from crowns is mathematically calculated based on location of crowns on user’s dentition) to be placed to account for a patient's asymmetrical dentition (Greenberg applied to dentition asymmetry of Cam, Figure 25A).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the fiducial markings of the asymmetrical splint on a patient’s asymmetrical dentition of Cam, so that the fiducial markings are also mathematically calculated to be placed to account for a patient's asymmetrical dentition, as taught by Greenberg, in order to provide an improved asymmetrical splint with additional fiducial markings that are calculated from known distances of a user’s dentition for providing an indication of the size of the user’s dentition (Greenberg, Paragraph 25).
However, the combination of Cam in view of Greenberg fails to explicitly disclose (2) the fiducial markings mark an extent of a symmetrical advancement by a MAD of the asymmetrical dentition.
Callender teaches an analogous splint 30 (Page 11, lines 8-22 and Figure 3, aligner 30 formed of upper and lower sections 31,32 to help maintain proper positioning of the mandible in a forward position for treatment of sleep apnea and snoring) wherein analogous fiducial markings (Page 11, lines 8-22, a numbers of lines or other visual indicia can be placed on the upper and lower sections 31 , 32 of the aligner 30 to assist the healthcare provider in measuring how much adjustment has been made over the course of treatment. In particular, marks can be made on the side of the aligner to indicate how much adjustment has been made) mark an extent of a symmetrical advancement by a MAD (Page 11, lines 8-22 and Figure 3) of the dentition.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the mathematically calculated fiducial markings of the asymmetrical splint on a patient’s asymmetrical dentition of Cam in view of Greenberg, so that the fiducial markings also mark an extent of a symmetrical advancement by a MAD of the asymmetrical dentition, as taught by Callender, in order to provide an improved asymmetrical splint with enhanced additional fiducial markings functionality that are applied for marking an extent mandibular advancement for assisting healthcare providers in determining the amount of adjustment over a treatment period (Callender, Page 11, lines 8-22).
Regarding claim 12, the combination of Cam in view of Greenberg in view of Callender discloses the invention as described above and further discloses wherein the placement (Greenberg, Paragraph 25, fiducial markings placement based on calculated distance of a user’s dentition, and is thereby independent of a titration mechanism) of the fiducial markings (Callender, Page 11, lines 18-26, numbers of lines or other visual indicia placed on the upper and lower sections 31 , 32 of the aligner 30 indicating mandibular advancement in anterior-posterior direction such that these additoinal fiducial markings of Callander are independent of titration advancement mechanism of Cam) is independent of a titration mechanism (Paragraphs 45-46, 52, 141 and 143 and Figure 25A, protrusion fin advancement structure is the structure as defined by the 35 USC 112f analysis above) used with the mandibular advancement device (MAD) 2500 (Cam, Paragraphs 141).
Conclusion
15. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lucas (US 20160378883 A1) teaches an asymmetrical splint for an asymmetrical dentition.
Conclusion
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Milo whose telephone number is (571)272-6476. The examiner can normally be reached on Mon-Fri 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached on +1(571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL MILO/
Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786