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 and amendments, see Applicant’s Remarks, filed on 01/08/2026, with respect to claims 1-3, 5 and 7-18 have been fully considered. The Double Patenting rejections previously presented are still applicable and maintained by the Examiner. Applicant’s arguments against the rejections in view of the prior art of record have been fully considered, but upon careful consideration are considered not persuasive.
Regarding Applicant’s assessment that EAO Channel (NPL relied upon) does not teach a method for enhancing alveolar augmentation in a patient consisting essentially of the claimed steps, the Examiners disagrees and applies the broadest reasonable interpretation (BRI) to these limitations (i.e. consisting essentially of). Since an Examiner must construe claim terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. The terms “consisting essentially of” does not exclude well known steps that one of ordinary skills in the art could considered obvious and pertinent to take during the surgical procedure (e.g. preparing the bone to receive the graft material). The step of “opening the gums” is not defined by the specification in a manner that would support a negative limitation which would exclude said well-known steps (e.g. the Specification describes: “A flap is elevated around the areas where vertical augmentation is desired to expose the alveolar ridge. The surfaces are debrided and cleared of debris (therefore, some surface preparation is performed before applying the graft material). According to still further exemplary aspects of the disclosure, the exposed affected portions can be cleaned with hand and/or ultrasonic and/or piezoelectric instrumentation in preparation for graft placement” [0043]). Additionally, the exposure of cancellous bone and removal of cortical bone still results in the required step of “opening the gum of a patient at one or more second locations along the alveolar ridge” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of the claimed invention. There is no evidence that exposing cancellous bone or removing cortical bone to arrive at the step of “opening the gum” would affect the basic and novel characteristic of the claimed invention. Therefore, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” MPEP section 2111.03 III
Regarding Applicant’s argument that the use by the prior art of a block of dentin teaches away from the claimed limitations, the Examiner notes that the claim is silent regarding the graft being “only particulate/ground” or not using a block graft. The prior art clearly discloses the use of particulate/ground dentin (minutes 1:08 to 1:18) and covering the graft material with a membrane (see minutes 1:19 to 1:30).
Additionally, claim 1 is rejected by a method that starts in minute 0:48 in the prior art. There is not additional step of an invasive bone removal after said minute 0:48 in the prior art. The Examiner notes that the Applicant alleges that the bone shown in minute 0:53 to minute 0:54 must have been prepared to receive the bone graft material, by removing native crestal and facial bone, and that the Applicant asserts that even though said preparation is not shown, the image implies that it must have been performed (see end pf page 9 to page 10). The Examiner considers that the reference is silent regarding any preparation that would aid the success of the bone grafting procedure; and in case that the image is evidence enough that said preparation took place, this additional procedure even though it could be consider more invasive does not invalidate the art and the rejection. Since there is no evidence that exposing spongy cancellous bone by removing native crestal and facial bone to arrive at the step of “opening the gum” would affect the basic and novel characteristic of the claimed invention, since there is not a negative limitation in the original claims or statement in the Specification that clearly asserts that said additional step affects the basic and novel characteristic of the claimed invention. Therefore, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” MPEP section 2111.03 III
The Affidavit or Declaration under 37 CFR 1.132 filed on 01/08/2026 is insufficient to overcome the rejection of claims 1-3, 5 and 7-18 based upon the prior art, as set forth in the last Office Action because: the reasons explained above with respect to applicants arguments.
The affidavit under 37 CFR 1.130 filed on 01/08/2026 is insufficient to overcome the rejection of the claims based upon Kurtzman et al. Journal of Osseo-Integration (NPL attached to the Office Action filed on 03/14/2025) as set forth in the last Office action because:
The affidavit is not persuasive as it is deem untimely. The affidavit is not timely filed (see MPEP 717.01(f) 2). The reference the Applicant is trying to invalidate was presented previously in prosecution, specifically in the Office Action filed on 03/14/2025. There is a lack of explanation as to why an affidavit was not presented earlier.
Additionally, there are only generic statements about the disclosure of the subject matter and no sufficient explanation as to the involvement of the authors of the article relied upon as NPL and being contested by the applicant (see MPEP 717.01(a)(1)).
Therefore generic statements of the alleged disclosure are not enough. Instead, explanations of how inventor disclosed the subject matter. Also, it would be necessary to disclose why the other authors were involved.
Double Patenting
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 5, 8-9 and 12-17 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 6, 11-13, 17 and 23-24 of U.S. Patent Application No. 17/746,332, hereafter, co-pending application, in view of Implant Practice US (please see PTO-892 and NPLs attached to the current Office Action), and further in view of Way (US 2020/0315745 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
It is clear that all the elements of claim 1 in the immediate application are found in claim 1 of the co-pending application, as analyzed in the table below. The claims are not identical; however, the method for enhancing alveolar augmentation in a patient, comprising: identifying a first location along the alveolar ridge of a patient for dimensional augmentation, opening the gum of a patient at the first location; packing a graft material comprising dentin onto the alveolar ridge and the first location; covering the graft material with a membrane; applying low magnitude high frequency vibration orally; wherein alveolar height is augmented vertically; would have been obvious over the method cited in the co-pending application.
The difference between the claims of the immediate application and the claims of the co- pending application lies in the fact that the immediate application’s claims include many more elements and steps, thus is much more specific. Thus, the invention of the immediate application anticipated by the co-pending application in proper combination with the prior art of record. Therefore, the immediate application is not patentably distinct from the claims of the co-pending application. Claims 1-3, 5, 8-9, and 12-17 in the immediate application have been analyzed and rejected with respect to claims 1-3, 6, 11-13, 17 and 23-24 in the co-pending application. Please see the double patenting analysis in the table below.
Instant Application (17/836,381)
Co-pending Application (17/746,332)
Claim 1 is rejected with respect to claims 1 and 13 of the co-pending application in view of Implant Practice US (please see PTO-892 and NPLs attached), and further in view of Way (US 2020/0315745 A1).
Claim 1
A method for enhancing alveolar augmentation in a patient, consisting essentially of: identifying a first location along the alveolar ridge corresponding to the position of one or more current teeth of a patient for dimensional augmentation, performing oral surgery on the patient further comprising:
opening the gum of a patient at the first location; packing a graft material comprising dentin onto the alveolar ridge at the first location; covering the graft material with a membrane; and suturing the membrane to close the gum opening; placing a mouthpiece over the dentition periodically starting on the day of the oral surgery; and applying low magnitude high frequency vibration to the mouthpiece; wherein alveolar height is augmented vertically.
Claim 1
A method for oral surgery, comprising: identifying a first location along the alveolar ridge corresponding to the position of one or more current or missing first teeth of a patient for alveolar bone height augmentation;
(The examiner notes that the term first and second location could be arbitrary determined, being obvious variants of each other.)
opening the gum of a patient at a second location along the alveolar ridge corresponding to the position of one or more current or missing second teeth while leaving the gum at the first location undisturbed, wherein the second locations are adjacent to the first location, wherein at least one second location includes a socket and/or alveolar defect; packing a graft material comprising dentin into the socket and/or alveolar defect; and covering the graft material with a membrane; wherein the alveolar bone height is increased across the alveolar ridge at the first location.
Claim 1
A method for enhancing alveolar augmentation in a patient, consisting essentially of: identifying a first location along the alveolar ridge corresponding to the position of one or more current teeth of a patient for dimensional augmentation, performing oral surgery on the patient further comprising:
opening the gum of a patient at the first location; packing a graft material comprising dentin onto the alveolar ridge at the first location; covering the graft material with a membrane; and suturing the membrane to close the gum opening; placing a mouthpiece over the dentition periodically starting on the day of the oral surgery; and applying low magnitude high frequency vibration to the mouthpiece; wherein alveolar height is augmented vertically.
Claim 13
A method for augmenting alveolar bone height lateral to a treatment site, comprising: identifying a first location along the alveolar ridge corresponding to the position of one or more current or missing first teeth of a patient for dimensional augmentation, packing a graft material comprising ground dentin at a second location along the alveolar ridge corresponding to the position of one or more current or missing second teeth laterally adjacent to the first location with the gum of the first location undisturbed; and covering the graft material with a membrane; wherein alveolar bone height is augmented across the alveolar ridge at the first location.
Claim 11 is rejected with respect to claims 1 and 13 of the co-pending application in view of Implant Practice US, further in view of Way.
Claim 11
A method for vertically augmenting alveolar bone lateral to a treatment site, consisting essentially of: identifying a location along alveolar ridge corresponding to the position of one or more current teeth of a patient for dimensional augmentation, packing a graft material at the location; placing a mouthpiece periodically over the dentition starting on the day of the oral surgery; and applying low magnitude high frequency vibration orally; wherein alveolar height is augmented at the location.
Claim 1
A method for oral surgery, comprising: identifying a first location along the alveolar ridge corresponding to the position of one or more current or missing first teeth of a patient for alveolar bone height augmentation; opening the gum of a patient at a second location along the alveolar ridge corresponding to the position of one or more current or missing second teeth while leaving the gum at the first location undisturbed, wherein the second locations are adjacent to the first location, wherein at least one second location includes a socket and/or alveolar defect; packing a graft material comprising dentin into the socket and/or alveolar defect; and covering the graft material with a membrane; wherein the alveolar bone height is increased across the alveolar ridge at the first location.
Claim 11
A method for vertically augmenting alveolar bone lateral to a treatment site, consisting essentially of: identifying a location along alveolar ridge corresponding to the position of one or more current teeth of a patient for dimensional augmentation, packing a graft material at the location; placing a mouthpiece periodically over the dentition starting on the day of the oral surgery; and applying low magnitude high frequency vibration orally; wherein alveolar height is augmented at the location.
Claim 13
A method for augmenting alveolar bone height lateral to a treatment site, comprising: identifying a first location along the alveolar ridge corresponding to the position of one or more current or missing first teeth of a patient for dimensional augmentation, packing a graft material comprising ground dentin at a second location along the alveolar ridge corresponding to the position of one or more current or missing second teeth laterally adjacent to the first location with the gum of the first location undisturbed; and covering the graft material with a membrane; wherein alveolar bone height is augmented across the alveolar ridge at the first location.
(The examiner notes that the term first and second location could be arbitrary determined, being obvious variants of each other).
The co-pending application fails to disclose the step of placing a mouthpiece over the dentition periodically starting on the day of the oral surgery; and applying low magnitude high frequency vibration to the mouthpiece. However, Implant Practice US discloses a method for accelerating graft conversion to alveolar bone; since the method includes the steps of bone augmentation and converting graft material (e.g. absorbable collagen wound dressing material and cortico-cancellous bone material) to alveolar bone, at the positions of extracted teeth 12 and 14, by using a vibrational device (please see section “Extraction with hard tissue augmentation” in page 4). Providing to the patient a vibrational dental device having a mouthpiece (bite plane) for contacting the dentition; since the patient is provided with a VPro™ high-frequency vibration, oral device with a bite plane; used for 5 minutes per day, post-extraction, to improve bone for future implants (page 2 and page 4).
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 co-pending application with the method of Implant Practice US, in order to include the step applying high frequency vibration 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 (please see section “Conclusion” in page 5).
The co-pending application and Implant Practice US, as combined above, fails to disclose the specific magnitude that is applied.
Way teaches a method for strengthening bone after a bone grafting procedure [0091] and stimulating bone formation and increasing bone mass [0009], comprising: identifying a patient having bone graft material (e.g., bone graft material is necessary for recited bone graft procedure) and one or more teeth comprising the patient’s dentition (see Fig. 3C; patient identified via providing treatment); providing to the patient a vibrational dental device (Fig. 1) having a mouthpiece (102) for contacting the dentition (see Fig. 3); and comprising the steps of placing the mouthpiece over the dentition (see Fig. 3; [0015] and [0091]); and applying a vibratory force during a predetermined number of sessions through a predetermined treatment period ([0015] and [0091]). Wherein a vibrational force of the vibrational dental device is high frequency and low magnitude; since the vibration unit is configured to deliver a vibration between about 30 Hz and about 200 Hz and at 0.030 G and 0.200 G ([0009] and [0012]). 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 the co-pending application and Implant Practice US in order to use a device that delivers an acceleration of the mouthpiece ranging from 0.030 G and 0.200 G, as taught by Way; since it has been shown that high frequency forces, even at low magnitude (e.g. 0.030 G and 0.200 G) are able to stimulate bone formation and increase bone mass ([0009]).
Claim 2 is rejected with respect to claim 2 of the co-pending application.
Claim 2
wherein the graft material comprises one or more of autologous dentin, mineralized or demineralized allograft or xenograft or a synthetic alloplastic bone substitute material.
Claim 2
wherein the graft material comprises autologous dentin.
Claim 3 is rejected with respect to claim 3 of the co-pending application.
Claim 3
further comprising the step of grinding one or more autologous teeth.
Claim 3
further comprising the step of grinding one or more autologous teeth.
Claim 5 is rejected with respect to claim 6 of the co-pending application.
Claim 5
wherein the step of opening the gum includes forming a periodontal flap.
Claim 6
wherein the step of opening the gum includes forming a periodontal flap.
Claim 8 is rejected with respect to claim 11 of the co-pending application.
Claim 8
wherein the membrane in the covering step is amnion-chorion membrane.
Claim 11
wherein the membrane in the covering step is amnion-chorion membrane.
Claim 9 is rejected with respect to claim 12 of the co-pending application.
Claim 9
wherein the graft comprises L-PRF block.
Claim 12
wherein the graft comprises L-PRF block.
Claim 12
wherein the graft material comprises autologous dentin.
Claim 2
wherein the graft material comprises autologous dentin.
Claim 13
further comprising the step of grinding one or more autologous teeth.
Claim 3
further comprising the step of grinding one or more autologous teeth.
Claim 14further comprising the step of forming a periodontal flap.
Claim 18
further comprising the step of forming a periodontal flap.
Claim 15
further comprising the step of covering the graft material with a membrane.
Claim 13
… covering the graft material with a membrane …
Claim 16
wherein the membrane in the covering step is amnion-chorion membrane.
Claims 11 and 23
wherein the membrane in the covering step is amnion-chorion membrane.
Claim 17
wherein the graft comprises L-PRF block.
Claims 12 and 24
wherein the graft comprises L-PRF block.
Claims 1-2, 11, 9 and 17 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 17 and 18 of U.S. Patent Application No. 17/452,874, hereafter, second co-pending application.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
It is clear that all the elements of claim 1 in the immediate application are found in claim 1 of the second co-pending application, as analyzed in the table below. The claims are not identical; however, the method for enhancing alveolar augmentation in a patient, comprising: identifying a first location along the alveolar ridge of a patient for dimensional augmentation, opening the gum of a patient at the first location; packing a graft material comprising dentin onto the alveolar ridge and the first location; covering the graft material with a membrane; applying low magnitude high frequency vibration orally; wherein alveolar height is augmented vertically; would have been obvious over the method cited in the second co-pending application.
The difference between the claims of the immediate application and the claims of the second co-application lies in the fact that the second co-application’s claims include many more elements and steps, thus is much more specific. Thus, the invention of the second co-application is in effect a “species” of the “generic” invention of the immediate application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claims in the immediate application are anticipated by the claims of the second co-pending application, therefore, the immediate application is not patentably distinct from the claims of the second co-pending application. Claims 1-2, 11, 9 and 17 in the immediate application have been analyzed and rejected with respect to claims 1, 17 and 18 in the second co-pending application. Please see the double patenting analysis in the table below.
Instant Application (17/836,381)
Second Co-pending Application (17/452,874)
Claims 1 and 11 are rejected with respect to claim 1 of the second co-pending application.
Claim 1
A method for enhancing alveolar augmentation in a patient, comprising: identifying a first location along the alveolar ridge corresponding to the position of one or more current teeth of a patient for dimensional augmentation, performing oral surgery on the patient further comprising:
opening the gum of a patient at the first location; packing a graft material comprising dentin onto the alveolar ridge at the first location; covering the graft material with a membrane; and suturing the membrane to close the gum opening; placing a mouthpiece over the dentition periodically starting on the day of the oral surgery; and applying low magnitude high frequency vibration to the mouthpiece; wherein alveolar height is augmented vertically.
Claim 11
A method for vertically augmenting alveolar bone lateral to a treatment site, comprising: identifying a location along alveolar ridge corresponding to the position of one or more current teeth of a patient for dimensional augmentation, packing a graft material at the location; placing a mouthpiece periodically over the dentition starting on the day of the oral surgery; and applying low magnitude high frequency vibration orally; wherein alveolar height is augmented at the location.
Claim 1
A method for accelerating graft conversion to alveolar bone, comprising: obtaining a vibrational dental device by a patient having an implant placed in grafted bone graft material in an extraction socket; wherein the vibrational dental device has a mouthpiece for contacting the dentition of the patient; placing the mouthpiece over the dentition; applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period beginning immediately after placement of the implant; wherein the graft material is converted to mature bone faster than without vibratory treatment.
Claim 2 is rejected with respect to claim 17 of the Second co-pending application.
Claim 2
wherein the graft material comprises one or more of autologous dentin, mineralized or demineralized allograft or xenograft or a synthetic alloplastic bone substitute material.
Claim 17
wherein the graft material includes demineralized cancellous allograft.
Claim 9 is rejected with respect to claim 18 of the Second co-pending application.
Claim 9
wherein the graft comprises L-PRF block.
Claim 18
wherein the graft material includes autologous L-PRF.
Claim 17 is rejected with respect to claim 18 of the Second co-pending application.
Claim 17
wherein the graft comprises L-PRF block.
Claim 18
wherein the graft material includes autologous L-PRF.
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, 10-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over EAO Channel in view of Implant Practice US, further in view of Way (US 2020/0315745 A1) and further in view of Kurtzman et al. Journal of Osseo-Integration, hereafter, Kurtzman (please see PTO-892 and NPLs attached).
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Regarding claim 1, EAO teaches method for enhancing alveolar augmentation in a patient (since the video shows a method of alveolar augmentation using autologous Dentin Graft from the Wisdom Tooth), consisting essentially of: identifying a first location (see minute 0:22 and Annotated Figure above) along the alveolar ridge corresponding to the position of one or more current teeth of a patient for dimensional augmentation, performing oral surgery on the patient further comprising: opening the gum of a patient at the first location (see minutes 0:49-0:53 and Annotated Figure above); packing a graft material comprising dentin onto the alveolar ridge at the first location (see minutes 1:08-1:18 and Annotated Figure above); covering the graft material with a membrane (membrane in the form of a white material, shown in minutes 1:19-1:32 and Annotated Figure above); and suturing the membrane to close the gum opening (see minute 1:33 and Annotated Figure above).
Wherein alveolar height is augmented vertically. The Examiner notes that as shown in (minute 0:53) the alveolar ridge was resorbed laterally as well as vertically; therefore, after grafting with denting there was an augmentation/increase of the resorbed alveolar, in both the horizontal and vertical direction, (please see also, minute 1:37 to 1:41). Additionally, in minutes 1:45 – 1:48 it is shown that the vertical bone height of the alveolar ridge at the first location was augmented; said preservation is more evident when comparing the images of minutes 1:45 – 1:48 with the one from minute 0:22 before graft material implantation or when looking at EAO Annotated Figure of minute 1:39 where the Dentin Graft from the wisdom tooth in addition to the particulated dentin graft (added in minutes 1:08 to 1:18) clearly augments the alveolar bone height at both locations.
EAO fails to disclose the step of placing a mouthpiece over the dentition periodically starting on the day of the oral surgery; and applying low magnitude high frequency vibration to the mouthpiece.
Implant Practice US discloses a method for accelerating graft conversion to alveolar bone, since the method includes the steps of bone augmentation and converting graft material (e.g. absorbable collagen wound dressing material and cortico-cancellous bone material) to alveolar bone, at the positions of extracted teeth 12 and 14, by using a vibrational device (please see section “Extraction with hard tissue augmentation” in page 4). Providing to the patient a vibrational dental device having a mouthpiece (bite plane) for contacting the dentition; since the patient is provided with a VPro™ high-frequency vibration, oral device with a bite plane; used for 5 minutes per day to improve bone (page 2 and page 4). 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 Implant Practice US, in order to include the step applying high frequency vibration 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 (please see section “Conclusion” in page 5). EAO and Implant Practice US, as combined above, fails to disclose the specific magnitude that is applied.
Way teaches a method for strengthening bone after a bone grafting procedure [0091] and stimulating bone formation and increasing bone mass [0009], comprising: identifying a patient having bone graft material (e.g., bone graft material is necessary for recited bone graft procedure) and one or more teeth comprising the patient’s dentition (see Fig. 3C; patient identified via providing treatment); providing to the patient a vibrational dental device (Fig. 1) having a mouthpiece (102) for contacting the dentition (see Fig. 3); and comprising the steps of placing the mouthpiece over the dentition (see Fig. 3; [0015] and [0091]); and applying a vibratory force during a predetermined number of sessions through a predetermined treatment period ([0015] and [0091]). Wherein a vibrational force of the vibrational dental device is high frequency and low magnitude, since the vibration unit is configured to deliver a vibration between about 30 Hz and about 200 Hz and at 0.030 G and 0.200 G ([0009] and [0012]).
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 the EAO/Implant Practice US in order to use Way’s device which delivers an acceleration of the mouthpiece ranging from 0.030 G and 0.200 G; since it has been shown that high frequency forces, even at low magnitude (e.g. 0.030 G and 0.200 G) are able to stimulate bone formation and increase bone mass ([0009]).
EAO/Implant Practice US/Way, as combined above, fails to disclose placing a mouthpiece over the dentition periodically starting on the day of the oral surgery.
Kurtzman discloses that methods for dental implant integration and accelerating graft conversion to alveolar bone by applying LMHFV to an implant site (page 38). Applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period, beginning immediately after placement of the implant, wherein the graft material is converted to mature bone faster than without vibratory treatment (page 38). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Implant Practice US’ method to include the step of Applying an axial vibratory force starting on the day of the oral surgery (beginning immediately after), since such modification can accelerate bone density surrounding the implants improving the expected clinical outcome in a shorter period than traditionally observed (page 38).
Regarding claim 2, EAO/Implant Practice US/Way/Kurtzman discloses the invention substantially as claimed. EAO discloses 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 discloses 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/Implant Practice US/Way/Kurtzman discloses the invention substantially as claimed. EAO discloses further comprising the step of grinding one or more autologous teeth (EAO: minute 0:40).
Regarding claim 5, EAO/Implant Practice US/Way/Kurtzman discloses the invention substantially as claimed. EAO discloses wherein the step of opening the gum includes forming a periodontal flap (minutes 0:48 to 0:53).
Regarding claim 10, EAO/Implant Practice US/Way/Kurtzman discloses the invention substantially as claimed. EAO discloses 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 discloses a method for vertically augmenting alveolar bone lateral to a treatment site (since the video shows a method of alveolar augmentation using autologous Dentin Graft from the Wisdom Tooth), consisting essentially of: identifying a location along alveolar ridge corresponding to the position of one or more current teeth of a patient for dimensional augmentation (minute 0:22), packing a graft material at the location (minute 1:08); wherein alveolar height is augmented at the location. The Examiner notes that once graft material comprising ground dentin is placed at the location, there is an alveolar bone height augmentation at the location, minute 1:39, where the Dentin Graft from the Wisdom Tooth in addition to the particulated dentin graft, added in minutes 1:08 to 1:18, clearly augments the alveolar bone height.
EAO fails to disclose the step of placing a mouthpiece periodically over the dentition starting on the day of the oral surgery; and applying low magnitude high frequency vibration orally.
Implant Practice US discloses a method for accelerating graft conversion to alveolar bone, since the method includes the steps of bone augmentation and converting graft material (e.g. absorbable collagen wound dressing material and cortico-cancellous bone material) to alveolar bone, at the positions of extracted teeth 12 and 14, by using a vibrational device (please see section “Extraction with hard tissue augmentation” in page 4). Providing to the patient a vibrational dental device having a mouthpiece (bite plane) for contacting the dentition; since the patient is provided with a VPro™ high-frequency vibration, oral device with a bite plane; used for 5 minutes per day to improve bone (page 2 and page 4). 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 Implant Practice US, in order to include the step applying high frequency vibration 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 (please see section “Conclusion” in page 5). EAO and Implant Practice US, as combined above, fails to disclose the specific magnitude that is applied.
Way teaches a method for strengthening bone after a bone grafting procedure [0091] and stimulating bone formation and increasing bone mass [0009], comprising: identifying a patient having bone graft material (e.g., bone graft material is necessary for recited bone graft procedure) and one or more teeth comprising the patient’s dentition (see Fig. 3C; patient identified via providing treatment); providing to the patient a vibrational dental device (Fig. 1) having a mouthpiece (102) for contacting the dentition (see Fig. 3); and comprising the steps of placing the mouthpiece over the dentition (see Fig. 3; [0015] and [0091]); and applying a vibratory force during a predetermined number of sessions through a predetermined treatment period ([0015] and [0091]). Wherein a vibrational force of the vibrational dental device is high frequency and low magnitude, since the vibration unit is configured to deliver a vibration between about 30 Hz and about 200 Hz and at 0.030 G and 0.200 G ([0009] and [0012]).
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 the EAO/Implant Practice US in order to use Way’s device which delivers an acceleration of the mouthpiece ranging from 0.030 G and 0.200 G; since it has been shown that high frequency forces, even at low magnitude (e.g. 0.030 G and 0.200 G) are able to stimulate bone formation and increase bone mass ([0009]).
EAO/Implant Practice US/Way, as combined above, fails to disclose placing a mouthpiece periodically over the dentition starting on the day of the oral surgery.
Kurtzman discloses that methods for dental implant integration and accelerating graft conversion to alveolar bone by applying LMHFV to an implant site (page 38). Applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period, beginning immediately after placement of the implant, wherein the graft material is converted to mature bone faster than without vibratory treatment (page 38). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Implant Practice US’ method to include the step of Applying an axial vibratory force starting on the day of the oral surgery (beginning immediately after), since such modification can accelerate bone density surrounding the implants improving the expected clinical outcome in a shorter period than traditionally observed (page 38).
Regarding claim 12, EAO/Implant Practice US/Way/Kurtzman discloses the invention substantially as claimed. EAO discloses wherein the graft material comprises autologous dentin; since EAO discloses 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 13, EAO/Implant Practice US/Way/Kurtzman discloses the invention substantially as claimed. EAO discloses further comprising the step of grinding one or more autologous teeth (minute 0:40).
Regarding claim 14, EAO/Implant Practice US/Way/Kurtzman discloses the invention substantially as claimed. EAO discloses further comprising the step of forming a periodontal flap (minutes 0:48 to 0:53).
Regarding claim 15, EAO/Implant Practice US/Way/Kurtzman discloses the invention substantially as claimed. EAO discloses further comprising the step of covering the graft material with a membrane (minute 1:20).
Regarding claim 18, EAO/Implant Practice US/Way/Kurtzman discloses the invention substantially as claimed. EAO discloses wherein the graft comprises a growth enhancer (since the graft material used, autologous dentin, comprises growth enhancer; e.g. BMP-2 and TGF- β; minutes 3:30 - 3:38).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over EAO/Implant Practice US/Way/Kurtzman, in view of Smiles Dental Group (please see NPL attached and PTO 892).
Regarding claim 7, EAO/Implant Practice US/Way/Kurtzman fails to specifically disclose wherein the step of opening the gum includes extracting a tooth. 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 discloses 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/Implant Practice US/Way/Kurtzman’ 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.
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over EAO/Implant Practice US/Way/Kurtzman in view of Elian (US 20200086000 A1).
Regarding claims 8 and 16, EAO/Implant Practice US/Way/Kurtzman fails to disclose wherein the membrane in the covering step is amnion-chorion membrane. On the other hand, Elian discloses 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 discloses 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/Implant Practice US/Way/Kurtzman 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/Implant Practice US/Way/Kurtzman in view of KometaBio (please see NPL attached and PTO 892).
Regarding claims 9 and 17, EAO/Implant Practice US/Way/Kurtzman fails to disclose wherein the graft comprises L-PRF block. However, KometaBio discloses 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/Implant Practice US/Way/Kurtzman 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 LUIS RUIZ whose telephone number is (571)270-0839. The examiner can normally be reached on M-F 8 Am - 5 PM (EST). 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/
Patent Examiner
Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772