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 Arguments
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive. Applicant has argued that the prior art of Makkar fails to provide for the new limitation of the impressions and registration are “self-created by the wearer”, however this is a broad limitation that is found in Makkar. Makkar discloses that it is the wear of the orthotic who creates the impressions and registration using their own mouth as cited in the following action. Further applicant has argued that Layzell fails to provide for the new limitation of “the kit including materials for the wearer to self-make” the impression and registration, however again this is a broad limitation and the kit of Layzell does provide such materials that for a wearer to self-make the impressions and registration as cited in the following action. Further Layzell does disclose that the material of the formable mouthpiece is adapted to be softened by heating as cited in the following action by discussing the chilling and warming of the mouthpiece material.
Other new limitations such as claim 15 reciting the location being a home is provided for in combination with new prior art of Katzman et al..
Specification
The amendments to the specification filed 10/24/2025 has been entered.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 2, and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makkar et al. (US 2011/0209714 A1).
Regarding claim 1, Makkar discloses A method for producing a remotely custom-fit dental orthotic (title and abstract, paragraph [0029] disclosing the manufacturing occurring a separate location from the steps of creating bite registrations):
receiving, at a manufacturing location (Figs. 2/7 element 104/204 being at the laboratory or manufacturing location that has received the impressions and bite from 102/202), upper and lower impressions of a wearer’s teeth and a bite registration of the wearer’s teeth (Fig. 2/7 elements 114/212 and 118/210 are taken at a first location 102/202 and then sent to a remote location 104/204),
the upper and lower impressions and the bite registration self-created by the wearer (paragraph [0037] lines 1-8 disclosing that it is the wearer themselves that self-creates the impressions and registration by biting their teeth together and paragraph [0044] lines 9-11 disclosing it is the patient themselves that would be creating the impressions by allowing a tray on their teeth to set and thus during the setting in the wearers mouth the wearer is self-creating the impressions thus it is the wearer self actions that actually create the impressions and registration) at a second location which is remote from the manufacturing location (Fig. 2/7 element 102/202, paragraph [0029] disclosing the impressions and bite registration are taken at a first location of an office or clinical setting that is remote and different than the manufacturing location);
creating models of the wearer’s upper and lower teeth using the upper and lower impressions (Fig. 2/7 element 120/214);
mounting the models on an articulator (Fig. 2/7 element 122/216);
setting a first position of the articulator using the mounted models and the bite registration wherein each of the mounted models is mated with a corresponding impression in the bite registration (paragraph [0008] lines 10-13); removing the bite registration from between the mounted models (paragraph [0008] lines 14-17 the registration removed when the shifting of the molds is done to increase the vertical amplitude); and
forming a custom dental orthotic between the mounted models with the articulator in the first position (paragraph [0008] lines 17-19, Fig. 2 element 124 or Fig. 7 element 218).
Regarding claim 2, Makkar further discloses wherein forming the custom dental orthotic comprises molding a moldable material between the mounted models and allowing the moldable material to harden (paragraph [0069] lines 6-11), and trimming the hardened moldable material (Fig. 2/7 elements 126/220 paragraph [0070] lines 1-8).
Regarding claim 5, Makkar further discloses wherein the first position comprises an orthopedically aligned position for the wearer (paragraph [0045] all disclosing the positioning of the bite registration in a desired positioning and thus an optimized positioning).
Regarding claim 6, Makkar further discloses creating the bite registration with the wearer’s teeth (Figs. 4a/6a and 4b showing the creation of the bite registration).
Regarding claim 7, Makkar further discloses wherein creating the bite registration comprises softening a bite registration material (Fig. 3a material 40 being softened enough for injection), tapping the wearer’s teeth together a plurality of times (paragraph [0033] lines 1-6 disclosing a cycle of the user adjusting the jaw position including where the teeth are made to touch and thus the tapping of teeth by the cycling, lines 8-9), placing the bite registration material between the wearer’s teeth, biting the bite registration material to form impressions of biting surfaces of the upper and lower teeth in the bite registration material (Fig. 6a element 40 placed and bitten), and allowing the bite registration material to harden (paragraph [0037] lines 6-8 the material is allowed to harden).
Regarding claim 8, Makkar further discloses wherein creating the bite registration comprises position by softening a bite registration material, placing the bite registration material between the wearer’s teeth, applying a positioning aid to the wearer’s teeth to urge the wearer’s jaw toward the orthopedically aligned position, biting the bite registration material to form impressions of biting surfaces of the upper and lower teeth in the bite registration material, and allowing the bite registration material to harden (Figs. 6a and 6b showing the bite position held by a spacer 42 with soften bite registration material 40 that is allowed to harden after in the desired position, Fig. 6b showing hardened material of the bite registration).
Regarding claim 9, wherein each impression comprises a tray holding moldable material, the moldable material molded around the wearer’s teeth and hardened to form a negative of the wearer’s teeth (Fig. 2 element 118 an impression is done for the upper and lower, paragraph [0044] lines 1-11 disclosing a moldable material and trays).
Claims 17-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Layzell et al. (US 2016/0158627 A1).
Regarding claim 17, Layzell discloses a method for custom-fitting for a remotely manufactured dental orthotic (title and abstract) the method comprising:
obtaining, at a wearer's location, a kit for custom-fitting a dental orthotic (see example kit 130 provided to a user at the user's location, Fig 28; a self-impression series kit is provided to a user to be custom fitted for a bite regulator as per paragraph [0126] ; kit 130 may be provided directly to the user by mail, paragraph [0127]),
the kit including materials for the wearer to self-make(title disclosing the kit is for “self-impression”) an upper impression of the wearer's upper teeth (each kit 130 includes impression material P to register the full anatomy of the teeth, paragraph [0128]; traditional impression trays and a single bite registration tool for an impression of the top teeth, paragraph [0147]; the kit is provided with trays for an upper impression, paragraph [0155]), a lower impression of the wearer's lower teeth (each kit 130 includes impression material P to register the full anatomy of the teeth, paragraph [0128]; the kit is provided with trays for a lower impression, paragraph [0155]), and a bite registration including impressions of bite surfaces of the wearer's upper and lower teeth (each kit includes impression material P to register bite registration, paragraph [0128]; see bite fork to determine the person's proper jaw alignment, Fig 29, paragraph [0130]; single dental impression bite tool for detailed impression, paragraph [0147]);
wherein the materials for self-making the bite registration comprise a formable mouthpiece which is adapted to be softened by heating the mouthpiece (Fig. 34, paragraph [0141] lines 6-15 disclosing the material is chilled before warming it up and softened such that it can be formed as the mouthpiece)
making the upper impression, the lower impression and the bite registration (three step process using impression trays and a bite registration tool to take impressions of the top teeth, bottom teeth, and bite registration, paragraph [0147]; the subject takes an upper impression, lower impression, and bite registration, paragraph [0155]); and
sending the upper impression, the lower impression and the bite registration to a manufacturing facility (the user packages the bite registration tool and impression material P in a return envelope and ships to a fabricator or manufacturer, paragraph [0152]; the user sends all the impressions to the fabricator, paragraph [0155)).
Regarding claim 18, Layzell further discloses wherein the materials for making the upper impression and lower impression each comprises comprising a dental tray (traditional impression trays, paragraph [0147]) and a moldable dental putty (each kit 130 includes impression material P to register the full anatomy of the teeth, paragraph [0128]; impression material P is rolled and compressed into shape and placed to take an impression of the teeth, paragraph [0141]- [0142]).
Regarding claim 19, Layzell further discloses wherein making the bite registration comprises making the bite registration while the wearer's teeth are in an orthopedically aligned position (the bite registration tool is used to determine each person's proper jaw alignment, paragraph [0130]; the user may perform physiological tests to determine the best position, paragraph [0139]; impression then taken for the correct bite position, paragraph [0142]-[0143]; customized bite-positioning mouthpiece that maintain optimized jaw alignment, paragraph [0076)).
Regarding claim 21, Layzell further discloses the method comprises placing the wearer's teeth in the orthopedically aligned position by: softening a bite registration material of the formable mouthpiece(the user rolls material P into a ball and compresses it to warm/soften it, paragraph [0141]);
placing the bite registration material between the wearer's teeth (the impression material is placed on both sides of the bite fork, paragraph [0142]; the bite fork with material P is placed in the mouth, paragraph [0143]);
urge the wearer's jaw toward the orthopedically desired aligned position (multiple trials using bite registration tools and notches to determine the best position by placing teeth into the tools, paragraph [0139]);
biting the bite registration material of the formable mouthpiece to form impressions of biting surfaces of the upper and lower teeth in the bite registration material (the subject slowly bites into the impression material P and dental bite registration tool making sure the teeth land in the correct bite position, paragraph [0143]);
and allowing the bite registration material to harden (allow the impression material to set, para [0143)).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Makkar et al. (US 2011/0209714 A1) in view of Ueckert et al. (US 10,238,477, hereafter Ueckert’477).
Regarding claim 3, Makkar discloses steps substantially identical to the instant application as discussed above but fails to explicitly disclose where the creating of the models comprising pouring fluid molding material into the upper and lower impression and allowing the fluid molding material to harden into the models.
However, Ueckert’477 disclose a method for producing a remote custom fit dental orthotic (title and abstract) with the steps of receiving a bite registration of a wear’s teeth (column 13 line 33-column 14 line 9) and upper and lower impressions of the teeth (column 13 lines 29-34) and a bite registration (column 13 lines 36-43) and creating a model of the wearer’s upper and lower teeth to be used in making the orthotic (column 13 lines 25-32) to be placed on an articulator (column 13 lines 33-34), and forming a custom dental orthotic (column 13 lines 45-49), where the creating of the models is by pouring fluid molding material into the upper and lower impression and allowing the fluid molding material to harden into the models (column 13 lines 25-33).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the step of creating of the models being by pouring fluid molding material into the upper and lower impression and allowing the fluid molding material to harden into the models as taught by Ueckert’477 into the forming of the mold models as taught by Makkar for the purpose of providing for physical replicas of the teeth for the creation of the orthotic by use of a simple conventional technique for reproducing positive models as taught by Ueckert’477 (column 13 lines 31-34).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Makkar et al. (US 2011/0209714 A1) in view of Lee et al. (US 2014/0308624 A1).
Regarding claim 4, Makkar discloses steps substantially identical to the instant application as discussed above but fails to explicitly disclose where the creating the models comprises 3-D scanning the upper and lower impressions, and generating 3-D prints complementary to the upper and lower impressions, the models comprising the 3-D prints.
Lee discloses a method of preparing a dental prosthesis (title and abstract) by taking impression of the upper and lower arches and a bite registration (S20, paragraph [0036] disclosing taking an upper impression by a tray, a lower impression aby a tray and a bite registration) and the creation of models by 3-d scanning the upper and lower impressions and generating 3-d prints complementary to the upper and lower impressions by 3-d printing models of teeth ( Fig. 1 s60, paragraph [0046] lines 4-21 printing denture models of the upper and lower scans).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the step of 3-d scanning impressions and 3-d printing models from those impression scans as taught by Lee into the creating of the models as taught by Makkar for the purpose of providing for the process of making models to be simplified, shortened and optimized as taught by Lee( paragraph [0020] lines 5-8).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Makkar et al. (US 2011/0209714 A1).
Regarding claim 10, Makkar discloses steps substantially identical to the instant application as discussed above but, including wherein removing the bite registration includes adjusting one or more controls of the articulator to allow the models to be moved apart and removing the bite registration (paragraph [0008] lines 14-17 disclosing moving the articulator apart which allows removing the bite registration from the first position), but fails to explicitly disclose returning the articulator to the first position, and adjusting the one or more controls of the articulator to fix the articulator in the first position and discloses an articulator that has controls to set positions (paragraph [0074] lines 1-13 disclosing the molds can be placed in centric occlusion and held there and then adjusted vertically by set amounts and thus having controls to allow and set the vertical adjustments). Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the method such that removing the bite registration comprises returning the articulator to the first position corresponding to the bite registration, and adjusting the one or more controls of the articulator to fix the articulator in the first position such that the custom dental orthotic may be formed between the mounted models in the correct position in order to have control over the starting measuring point from the actual bite registration to the desired vertical adjustment away from the patient’s current vertical adjustment starting point.
Regarding claim 16, Makkar discloses a method for producing remotely custom-fit dental orthotics (title and abstract): with the steps of:
receiving, at a manufacturing location, a plurality of custom fitting elements (Fig. 2 showing custom fitting elements of bite registration and upper/lower impressions are made of an athlete and sent to the manufacturing location 104),
the set corresponding to a wearer at a wearer location (Fig. 2 element 102 being at a first wearer location separate from the manufacturing location as per paragraph [0029]) and the set comprising upper and lower impressions of the corresponding wearer’s teeth and a bite registration of the corresponding wearer’s teeth (Fig. 2 elements 114 and 118) and the set being self-created by the corresponding wearer (paragraph [0037] lines 1-8 disclosing that it is the wearer themselves that self-creates the impressions and registration by biting their teeth together and paragraph [0044] lines 9-11 disclosing it is the patient themselves that would be creating the impressions by allowing a tray on their teeth to set and thus during the setting in the wearers mouth the wearer is self-creating the impressions thus it is the wearer self actions that actually create the impressions and registration); and
for the received set of custom fitting elements: creating models of the corresponding wearer’s upper and lower teeth using the upper and lower impressions (Fig. 2 element 120), mounting the models on an articulator and setting a first position of the articulator using the mounted models and the bite registration (Fig. 2 element 122), wherein each of the mounted models is mated with a corresponding impression in the bite registration (paragraph [0008] lines 10-13); removing the bite registration from between the mounted models (paragraph [0008] lines 14-17 the registration removed when the shifting of the molds is done to increase the vertical amplitude),
forming a custom dental orthotic between the mounted models with the articulator in the first position (paragraph [0008] lines 17-19, Fig. 2 element 124 or Fig. 7 element 218), and returning the custom dental orthotic to the corresponding wearer (Fig. 8 showing the wearer actually wearing the customized orthotic and thus requiring the returning to the wearer).
Makkar discloses steps substantially identical to the instant application as discussed above, including the that method is applicable to different types of athletes (paragraph [00562] lines 10-13 “the mouthpiece 50 can be suitable for golfers, runners, cyclists, swimmers, tennis players, baseball players, volleyball players, archers, etc.”) but fails to explicitly disclose the receiving at the manufacturing location of a set of custom fitting elements is a plurality of sets, nor the each set corresponds to a different wearer, and for each set performing the above producing steps, however as Makkar discloses that the mouthpiece would be suitable for multiple different types of athletes it would have been obvious to receive a plurality of sets for multiple different wearers corresponding to different wearers as Makkar is motivated to be used for multiple different wearers to provide multiple people with the benefits of the orthotic and for anyone that would be using the method to have a functioning business of providing services to more than one person.
Claims 11-13 is rejected under 35 U.S.C. 103 as being unpatentable over Makkar et al. (US 2011/0209714 A1) in view of Layzell et al. (US 2016/0158627 A1).
Regarding claim 11. Makkar discloses steps substantially identical to the instant application as discussed above, including where a custom kit would have been sent to the wearers location (paragraph [0029] disclosing the impressions and registration are done at the wearers location that is separate from the manufacturing location and would include materials for making the upper and lower impressions and bite registration, paragraph [0044] disclosing suitable mold trays sent, and Fig. 2 showing bite registration material at the location 110) but fails to explicitly disclose where those materials are send from the manufacturing location.
However, Layzell discloses a method for custom-fitting for a remotely manufactured dental orthotic (title and abstract) and sending to a wearer's location, a kit for custom-fitting a dental orthotic (see example kit 130 provided to a user at the user's location, Fig 28; a self-impression series kit is provided to a user to be custom fitted for a bite regulator as per paragraph [0126] ; kit 130 may be provided directly to the user by mail, paragraph [0127]) that is sent from the manufacturing location (paragraph [0152] lines 1-7, disclosing the kit was sent with a return envelope or bag that would return the kit to the manufacturer and thus the kit was sent from the manufacturer location).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the step of those materials being send from the manufacturing location as taught by Layzell into the method as taught by Makkar for the purpose of providing for ease of use in the system and such that the manufacture would be able to return the completed orthotic back to wearer location as taught by Layzell (paragraph [0152] lines 15-19).
Regarding claims 12 and 13, Makkar/Layzell as combined above discloses steps substantially identical to the instant application as discussed above, including where the materials include dental trays and/or a bite spacing member (paragraph [0044] lines 9-10 disclosing trays, Fig. 4a element 42) but fails to explicitly disclose where the material for the upper and lower impressions or the bite registration are moldable putties nor where the bite spacing member is a bite fork.
However, Layzell discloses a method for custom-fitting for a remotely manufactured dental orthotic (title and abstract) and sending to a wearer's location, a kit for custom-fitting a dental orthotic (see example kit 130 provided to a user at the user's location, Fig 28; a self-impression series kit is provided to a user to be custom fitted for a bite regulator as per paragraph [0126] ; kit 130 may be provided directly to the user by mail, paragraph [0127]) and the kit impression materials for the upper and lower impressions and the bite registration being a moldable putty (paragraph [0127] lines 1-5 disclosing the impression putty P, paragraph [0128] lines 1-16 disclosing the registration is by putty) and the bite registration being done with a bite fork (paragraph [0020] all).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate those materials for the impression and registration being of a moldable putty and the bite spacer being a bite fork as taught by Layzell into the method as taught by Makkar for the purpose of providing for ease of use in the system and that the material could be sent in sufficient packages for multiple attempts and for a superior impression and for a bite fork that would help with proper location for the bite registration as taught by Layzell (paragraph [0128] lines 1-30, paragraph [0150] lines 1-6, and paragraph [0020] all).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Makkar et al. (US 2011/0209714 A1) in view of Layzell et al. (US 2016/0158627 A1) and further in view of Knutson et al. (2007/0037116 A1).
Regarding claim 14, Makkar/Layzell as combined above discloses steps substantially identical to the instant application as discussed above, including where the materials for forming the bite registration include a mouthpiece (Fig. 4a element 42) but fails to explicitly disclose where the mouthpiece is adapted to be softened by heating
However, Knutson teaches an occlusal indicator tray and process of use (title and abstract) having a formable mouthpiece (Figs. 4/ 5) that is softened by heating (abstract, “the mouthpiece is heated, the teeth forcefully bite into the tray) such that the mouthpiece allows for bite registration (paragraph [0006] all).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the material for a bite record being a mouthpiece that is heat softened as taught by Knutson into the method as taught by Makkar for the purpose of providing for a bite record that has greater accuracy as taught by Knutson (paragraph [0007] lines 1-3 and [0129] all).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Makkar et al. (US 2011/0209714 A1) in view of Katzman et al. (US 20180368943 A1).
Regarding claim 15, Makkar as combined above discloses steps substantially identical to the instant application as discussed above including where the impressions and registration were made at a second location different from a manufacturing location (paragraph [0029] lines 6-8, Fig. 2 element 102, 114, 118, disclosing the creation of the upper and lower impressions and the bite registration are done at the remote location that is separate from the manufacturing location), but fails to explicitly disclose where the second location is a come of the wearer.
However, Katzman teaches a method of making remote custom dental orthotic (title and abstract) by sending an impression kit to a wearer’s home for the wearer to self-create impressions (paragraph [0002] lines 1-3, “application of a dental impression kit at home”, paragraph [0142] all, disclosing the dental impression kits are for use by a person at home).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the second location for sending the kit being a wearer’s home as taught by Katzman into the method as taught by Makkar for the purpose of providing a kit that would not require significant time of going to a dental office as taught by Katzman (paragraph [0004] lines 1-3 disclosing that going to a dental office requires significant time and thus sending the kit to the wearer’s home would avoid such time and visits).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
Applicant's amendment necessitated the new 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 MATTHEW P SAUNDERS whose telephone number is (571)270-3250. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.P.S/Examiner, Art Unit 3772 01/23/2026
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772