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 .
Drawings
The drawings were received on 06/09/2026. These drawings are accepted.
Specification
The specification was received on 06/09/2026. This specification is accepted.
Response to Amendment
The amendment filed 06/09/2026 has been entered. Currently, claims 1-13 remain pending in the application. Claims 1-12 and new claim 13 were amended by Applicant without the addition of new matter. Applicant’s drawings, specification, and claims 9-10 were amended to overcome drawing objections and 35 USC 112(B) previously set forth in the Non-Final Office Action mailed 01/09/2026. Lastly, pending claim objections, double patenting rejections, and 35 USC 112(B) rejections remain below.
Response to Arguments
Applicant's arguments, see Remarks filed 04/19/2021 have been fully considered and they are persuasive. Applicant’s amendment to claim 1 has overcome the previous 35 USC 102 and 35 USC 103 rejections.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
In claims 1 and 11 rephrase “the splint” to read --the asymmetrical splint-, respectively.
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 3-5 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.
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--.
Double Patenting
8. 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.
9. Claims 1-7, 9, 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, and the 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.
All of the limitations of claim 7 can be found in claim 1 of U.S. Patent No. 12102501.
All of the limitations of claim 9 can be found in claim 1 of U.S. Patent No. 12102501.
All of the limitations of claim 11 can be found in claim 1 of U.S. Patent No. 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.
Allowable Subject Matter
10. Claims 1-13 are allowed over 35 USC 102 and 103, pending correction to the double patenting and 35 USC 112(B) rejections recited above.
11. The following is an examiner’s statement of reasons for allowance:
The closest prior art is to 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), wherein the asymmetrical splint 2502,2504 comprises an occlusal surface (Paragraphs 77, 118, 141 and Figure 25A, occlusal surface having advancement structures) and 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).
Greenberg (U.S. Patent Pub. No. 20090113714) 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).
Callender (WO 2010087824 A1) 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.
Garcia et al. (US 20200163795 A1) teaches an asymmetrical splint (Paragraphs 135-136, asymmetrical splint having contact surfaces 3a of different curved dimension on each of left and right molars to allow for symmetrical advancement of both sides as given by a curved trajectory equation) for a mandibular advancement device (MAD) wherein the asymmetrical advancement for each of the right and left sides of the asymmetrical splint is determined by equation.
Based on the structures of Greenberg, Callender, Garcia and any other prior art it would be improper hindsight to modify Cam so that asymmetrical advancement for each of a right and left side of the asymmetrical splint is determined by: tangent line =parallel line ÷ cos (tangent angle) where, the tangent line is tangential to splint curvature at a point, the point is selected on the asymmetrical splint to which an adjustment mechanism of the mandibular advancement device (MAD) is to be attached, the parallel line is parallel to anteroposterior (A/P) axis, and the tangent angle is between the tangent line and the parallel line. One of ordinary skill would instead be drawn to the structure of Garcia for the asymmetrical advancement of the left and right sides of the splint and the symmetrical advancement of the mandible; however, Garcia does not provide the same equation for advancement and Applicant provides criticality in Specification, Paragraph 25 of reduced stress on mandible, which makes it improper hindsight to modify Garcia as claimed. Therefore, the combination of features is considered to be allowable.
Claims 2-13 depend on claim 1 and so they are also allowed.
Conclusion
Applicant's amendment necessitated the ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL MILO/
Art Unit 3786
/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
Prosecution Insights