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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/04/2026 has been entered.
Response to Arguments
Applicant’s arguments and amendments, see Applicant’s Remarks, filed on 08/04/2026, have been fully considered. Applicant’s arguments against the rejections in view of the prior art of record have been fully considered, but are not persuasive, as they do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments and clarifications.
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 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.
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Claims 1-3, 5, 10-11, 20-21 and 23-29 are rejected under 35 U.S.C. 103 as being unpatentable over EAO Channel (please see NPL attached and PTO 892) in view of Teixeira (US 20190239992 A1).
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Regarding claim 1, EAO discloses a method for enhancing alveolar augmentation in a patient (The video shows a method of alveolar augmentation using autologous Dentin Graft from the Wisdom Tooth), comprising: identifying an augmentation site along an alveolar ridge of a the patient for dimensional augmentation, the augmentation site being outside a bony envelope of the alveolar ridge (Minute 0:24 and Annotated Figure of minute 0:24, above). The Examiner applies the broadest reasonable interpretation of the term “bony envelope”, being the three-dimensional bony housing that defines the shape and boundaries of the alveolar ridge, and provides the osseous support for the teeth or implants.
Accessing the augmentation site (Minute 0:49 – 0:50, see Figure above); placing a graft material comprising dentin (the Dentin Graft from the Wisdom Tooth in addition to the particulated dentin graft is added in minutes 1:08 to 1:18, see Annotated Figure of minute minutes 1:08 to 1:18 above, clearly the graft augments the alveolar bone height). Whereby alveolar bone is vertically augmented outside the bony envelope of the alveolar ridge at the augmentation site (see Annotated Figure of minute 1:33, where the entire structure of the alveolar bone has been augmented three-dimensionally by the graft material, at the augmentation site; see also the summary of the procedure in minute 5:14).
However, EAO fails to disclose “at the augmentation site; positioning a mouthpiece in contact with at least one target tooth or target dental implant proximate the augmentation site; and repeatedly applying, through the mouthpiece, a low magnitude high frequency vibratory force that is transmitted through the at least one target tooth or target dental implant to load alveolar bone at the augmentation site, the applying beginning after the graft material is placed and continuing over a plurality of treatment sessions”.
Teixeira teaches a method for accelerating graft conversion to alveolar bone, since the method includes the steps of improve the healing process of bone after grafting ([0036]), by using a vibrational device ([0040]). Providing to the patient a vibrational dental device having a mouthpiece (bite plate) for contacting the dentition ([0060]).
Therefore, Teixeira teaches at the augmentation site; positioning a mouthpiece in contact with at least one target tooth or target dental implant proximate the augmentation site (since the method comprises the step of applying high frequency, low magnitude forces to teeth to increase bone density of alveolar bone, resulting in increased bone density around the teeth and adjacent bone [0013]); and repeatedly applying, through the mouthpiece, low magnitude (e.g. 0.1 to 2.0 g [0028]) high frequency vibratory (e.g. 10 to 1000 Hz [0028]) force that is transmitted through the at least one target tooth or target dental implant to load alveolar bone at the augmentation site (the mouthpiece is a low magnitude high frequence device for implant success, [0035]), the applying beginning after the graft material is placed and continuing over a plurality of treatment sessions ( since the stimulation of the present invention can spread into adjacent bone, and will improve the healing process of bone after grafting [0036] and the bite plate 100 may be used at home (daily or weekly) for shorter period of time, e.g., 5 minutes [0061]).
Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the claimed invention, to modify the EAO’s method with the method of Teixeira, in order to include the steps of applying low magnitude (e.g. 0.1 to 2.0 g [0028]) high frequency vibratory (e.g. 10 to 1000 Hz [0028]) orally, since high-frequency vibration devices help improve quality bone for implants and has an anabolic effect through activation of osteoblasts to stimulate bone growth and improve bone density ([0013] and [0044]).
Regarding claim 2, EAO and Teixeira, as combined above, teach the invention substantially as claimed. EAO teaches wherein the graft material comprises one or more of autologous dentin, mineralized or demineralized allograft or xenograft or a synthetic alloplastic bone substitute material (since EAO teaches the extraction of a wisdom tooth, minute 0:31, the separation of the tooth in halves, minute 0:36, the particulation of the tooth, minute 0:40, and the step of applying the particulated dentin graft material, minute: 1:09).
Regarding claim 3, EAO and Teixeira, as combined above, teaches the invention substantially as claimed. EAO teaches further comprising the step of grinding one or more autologous teeth (EAO: minute 0:40).
Regarding claim 5, EAO, EAO and Teixeira, as combined above, teaches the invention substantially as claimed. EAO teaches wherein accessing the augmentation site comprises opening a gum of the patient and includes forming a periodontal flap (minutes 0:48 to 0:53).
Regarding claim 10, EAO and Teixeira, as combined above, teaches the invention substantially as claimed. EAO teaches wherein the graft comprises a growth enhancer (since the graft material used, autologous dentin, comprises growth enhancer; e.g. BMP-2 and TGF- β; please see minutes 3:30 - 3:38).
Regarding claim 11, EAO discloes a method for treating an alveolar ridge of a patient having a graft material comprising dentin placed at an augmentation site outside a bony envelope of the alveolar ridge (since the video shows a method of alveolar augmentation using autologous Dentin Graft from the Wisdom Tooth). The Examiner applies the broadest reasonable interpretation of the term “bony envelope”, being the three-dimensional bony housing that defines the shape and boundaries of the alveolar ridge, and provides the osseous support for the teeth or implants. Whereby alveolar bone is vertically augmented outside the bony envelope of the alveolar ridge at the augmentation site (see minute 1:33, where the entire structure of the alveolar bone has been augmenter three-dimensionally by the graft material, at the augmentation site; see also the summary of the procedure in minute 5:14).
EAO fails to disclose the step of “positioning a mouthpiece in contact with at least one target tooth or target dental implant proximate the augmentation site; and repeatedly applying, through the mouthpiece, a low magnitude high frequency vibratory force that is transmitted through the at least one target tooth or target dental implant to load alveolar bone at the augmentation site, the applying beginning after the graft material is placed and continuing over a plurality of treatment sessions”.
Therefore, Teixeira teaches positioning a mouthpiece in contact with at least one target tooth or target dental implant proximate the augmentation site (since the method comprises the step of applying high frequency, low magnitude forces to teeth to increase bone density of alveolar bone, resulting in increased bone density around the teeth and adjacent bone [0013]); and repeatedly applying, through the mouthpiece, low magnitude (e.g. 0.1 to 2.0 g [0028]) high frequency vibratory force (e.g. 10 to 1000 Hz [0028]) that is transmitted through the at least one target tooth or target dental implant to load alveolar bone at the augmentation site (the mouthpiece is a low magnitude high frequence device for implant success, [0035]), the applying beginning after the graft material is placed and continuing over a plurality of treatment sessions (since the stimulation of the present invention can spread into adjacent bone, and will improve the healing process of bone after grafting [0036] and the bite plate 100 may be used at home (daily or weekly) for shorter period of time, e.g., 5 minutes [0061]).
Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the claimed invention, to modify the EAO’s method with the method of Teixeira, in order to include the steps of applying low magnitude (e.g. 0.1 to 2.0 g [0028]) high frequency vibratory (e.g. 10 to 1000 Hz [0028]) orally, since high-frequency vibration devices help improve quality bone for implants and has an anabolic effect through activation of osteoblasts to stimulate bone growth and improve bone density ([0013] and [0044]).
Regarding claims 20, 21 and 23, EAO and Teixeira, as combined above, teach the invention substantially as claimed. Wherein the vibratory force is applied primarily along a single axis, wherein the single axis lies in a sagittal plane of a mouth of the patient and wherein the mouthpiece is clamped between opposing occlusal surfaces of the dentition during the applying step. Since a low magnitude high-frequency vibration device is used, said type of vibratory mouthpieces are well known in the art to apply an axial vibratory force on the occlusal surfaces of the teeth, see [0085].
Regarding claim 24, EAO and Teixeira, as combined above, teach the invention substantially as claimed. Wherein the vibratory force loads the alveolar bone at a magnitude and a frequency selected to promote conversion of the graft material to bone (since the method taught by the combination teaches that it has been shown that high frequency forces, even at low magnitude (e.g. 0.1 to 2.0 G) are able to stimulate bone formation and increase bone mass ([0028]).
Regarding claims 25, 26 and 27, EAO, EAO and Teixeira, as combined above, teach the invention substantially as claimed. Teixeira teaches wherein the vibratory force has a frequency of from about 45 Hz to about 150 Hz, wherein the frequency is about 113 Hz. and wherein the vibratory force has an acceleration of from about 0.010 G to about 0.15 G (since the vibration unit is configured to deliver a vibration between about 10 to 1000 Hz and at 0.1 to 2.0 G ([0028]).
Regarding claim 28, EAO and Teixeira, as combined above, teach the invention substantially as claimed. Teixeira teaches wherein each of the plurality of treatment sessions has a duration of from about 30 seconds to about 20 minutes (since it could be used for 5 minutes per day to improve bone ([0061]).
Regarding claim 29, EAO and Teixeira, as combined above, teach repeated on a daily basis over the plurality of treatment sessions (Teixeira: [0061]), but fails to specifically teach, “wherein the applying begins on a day the graft material is placed”.
However, it would have been obvious to one of ordinary skills in the art to try applying the LMHFV beginning on a day the graft material is placed, since such approach would increasing osteoblastic activity around the grafted site, thereby preparing the graft to be in a healthier condition for osseointegration. For instance, a person of ordinary skills attempting to accelerate osseointegration will be led to try beginning the vibration treatment on the day the graft material is placed to shorten the time it takes for achieving implant/graft success.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over EAO, in view of Teixeira, further in view of Smiles Dental Group (please see NPL attached and PTO 892).
Regarding claim 7, EAO and Teixeira teach accessing the augmentation site comprises opening a gum of the patient (EAO: minute 0:49), but fail to specifically teach “and extracting at least one secondary tooth or removing at least one secondary dental implant, the at least one secondary tooth or secondary dental implant being adjacent to the augmentation site”. However, the Examiner notes that this specific step of extracting a tooth would depend on the specific dentition of the patient, where some patients, as the one shown in EAO, would have the bone defect in an area where a missing tooth have existed for some time.
Smiles Dental Group teaches a surgical procedure where a patient having a defective/compromised tooth is extracted and the socket is treated with bone graft material in order to preserve and avoid bone resorption. Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the claimed invention, to modify the EAO/Teixeira’s method with the method of Smiles Dental Group; since such modification would make it clear to any dental provider that the procedure requires the extraction of a defective tooth when the patients conditions require it.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over EAO, in view of Teixeira, further in view Elian (US 20200086000 A1).
Regarding claim 8, EAO and Teixeira teach further comprising covering the graft material with a membrane (EAO: minutes 1:20 to 1:32), but fails to teach “wherein the membrane is an amnion- chorion membrane”. On the other hand, Elian teaches a dental bone graft that may be used to reverse bone loss or destruction caused by, for example, periodontal disease or trauma. Some grafts are performed to rebuild bone structure to support dental implants; membranes may be used to stabilize the graft as it heals ([0132]).
Elian teaches wherein the membrane in the covering step is amnion-chorion membrane ([0151]). Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify the method of EAO/Teixeira to include the use of an amnion-chorion membrane, as taught by Elian; since such modification would provide a membrane that is rich in collagen; therefore, avoiding the resorption of soft tissue (gum) while allowing bone integration between the graft and the membrane.
Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over EAO, in view of Teixeira, further in view of KometaBio (please see NPL attached and PTO 892).
Regarding claims 9 and 17, EAO and Teixeira, fail to teach wherein the graft comprises L-PRF block. However, KometaBio teaches a method of repairing an extraction socket using dentin and graft material comprising L-PRF block (minutes 2:23-3:27). It would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify the method of EAO/Teixeira to include the use of a graft comprises L-PRF block, as taught by KometaBio; since such modification would create a graft that accelerates the natural healing process by providing a bioactive “band-aid” to enhance the recovery process.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over EAO, in view of Teixeira, further in view of Way (US 20200093574 A1).
Regarding claim 22, EAO and Teixeira, fail to teach “wherein the vibratory force is applied along an axis other than a superior-inferior masticatory axis”.
Way teaches a method for strengthening bone [0020], using a vibratory mouthpiece [0032]; wherein the vibratory force is applied along an axis other than a superior-inferior masticatory axis (since the vibrator can be arranged to create vibration in two or three axes and the biteplate of mouthpiece may cyclically move in one or more of the three spatial axes [0032]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify the method of EAO/Teixeira to include the use of a mouthpiece that applies vibration in more than one spatial axes, since such modification would aid the strengthening and augmentation of the bone in more than one direction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS MIGUEL RUIZ MARTIN whose telephone number is (571)270-0839. The examiner can normally be reached M-F 8 Am - 5 PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (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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/LUIS RUIZ MARTIN/
Examiner, Art Unit 3772
/HEIDI M EIDE/Primary Examiner, Art Unit 3772
9/3/2026