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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/20/2025 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks filed 11/20/2025, have been fully considered. Upon careful consideration the Examiner finds that the claims are not patentable over the prior art of record. Applicant’s arguments against the rejections in view of the prior art of record have been fully considered, but are not persuasive.
The affidavit under 37 CFR 1.132 filed on 11/20/2025 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.
The Examiner Respectfully disagrees with Applicant’s assessments. Implant Practice US, primary reference relied upon (NPL attached to the Office Action filed on 02/21/2024), discloses the limitations of independent claim 1 substantially as claimed, except: “applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period beginning immediately after placement of the implant”. Beginning immediately after placement of the implant, being the specific part of the limitations that is missing in Implant Practice US’ disclosure. However, Kurtzman, secondary reference (NPL attached to the Office Action filed on 03/14/2025), discloses 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 (Since “when applied in immediate implant loading, LMHFV can accelerate bone density surrounding the implants improving the expected clinical outcome in a shorter period than traditionally observed” [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 beginning immediately after placement of the implant, since such modification can accelerate bone density surrounding the implants improving the expected clinical outcome in a shorter period than traditionally observed (page 38).
The Examiner notes that the Applicant clarifies in page 12 of the Remarks that the phrase “beginning immediately after placement of the implant” refers to a clinical timescale, and not an absolute one. In other words, vibration is not applied the instant the surgeon completes an implantation procedure, but rather as soon as possible after surgical recovery, as would be understood by one of ordinary skill in the art, as explained by the Applicant. The Examiner further notes that Kurtzman provides a teaching for this specific clinical timescale (It also has osseous stimulatory effects in cases where the implant will not be immediately loaded and allowed to heal before initiation of the restorative phase; the positive effects of LMHFV on implant osseointegration have been demonstrated [page 38]).
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 1-2, 4-5, 13-15 and 19-21 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-10 of U.S. Patent Application No. 18/652,284, hereafter, 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 co-pending application, as analyzed below. The claims are not identical; however, 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; 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-application lies in the fact that the co-application’s claims include many more elements and steps, thus is much more specific. Thus, the invention of the 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 co-pending application, therefore, the immediate application is not patentably distinct from the claims of the co-pending application. Claims 1-2, 4-5, 13-15 and 19-21 in the immediate application have been analyzed and rejected with respect to claims 1-10 in the co-pending application. Please see the double patenting analysis below.
Claim 1 is rejected with respect to claim 1 of the co-pending application.
Claim 2 is rejected with respect to claim 2 of the co-pending application.
Claim 4 is rejected with respect to claim 4 of the co-pending application.
Claim 5 is rejected with respect to claim 5 of the co-pending application.
Claim 13 is rejected with respect to claim 6 of the co-pending application.
Claim 14 is rejected with respect to claim 7 of the co-pending application.
Claim 15 is rejected with respect to claim 8 of the co-pending application.
Claim 19 is rejected with respect to claim 1 of the co-pending application.
Claim 20 is rejected with respect to claim 9 of the co-pending application.
Claim 21 is rejected with respect to claim 9 of the co-pending application.
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.
Claims 1 and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Implant Practice US, evidenced by Dental Products Report (please see PTO-892 form and NPLs attached to the Office Action filed on 02/21/2024) in view of Kurtzman et al. Journal of Osseo-Integration, hereafter, Kurtzman (see PTO-892 form and NPL attached to the Office Action filed on 03/14/2025).
As per claim 1, Implant Practice US discloses 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), comprising:
obtaining a vibrational dental device by a patient (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, page 2 and page 4. The Examiner notes that the VPro™ oral device has a mouthpiece as evidenced by Dental Products Report) having an implant placed in grafted bone graft material in an extraction socket (since the implant is placed after hard tissue augmentation with the graft material described in the “Extractions with hard tissue augmentation” section at the specified locations; i.e. teeth 12 and 14); wherein the vibrational dental device has a mouthpiece (bite plane) for contacting the dentition of the patient (VPro™ high-frequency vibration, oral device with a bite plane; used for 5 minutes per day):
placing the mouthpiece over the dentition; applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period (used for 5 minutes per day, post-extraction, page 2 and page 4); wherein the graft material is converted to mature bone faster than without vibratory treatment (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).
Implant Practice US fails to specifically disclose “applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period beginning immediately after placement of the implant”.
However, 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 beginning immediately after placement of the implant, 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 claims 6-12, The Examiner notes that Implant Practice US and Kurtzman, as combined above, discloses all the limitations as claimed. Since Implant Practice US’ 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 high-frequency vibrational device (please see “Extraction with hard tissue augmentation” in page 4). The Examiner further notes that it is well known in the art that applying a high frequency vibration to a patient’s dentition promotes the biological mechanisms that promote bone growth (Conclusion, page 5). The Examiner further notes that devices having the same structures and delivering the same parameters would create the same results, as it is the case of the prior art of record and the immediate application. Additionally, considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom (Implicit Disclosure MPEP 2144.01).
For the reasons provided above Implant Practice US teaches “wherein an infiltration of granulation tissue into a clot is enhanced compared to than without vibratory treatment”, “wherein a proliferation by epithelium into an extraction site is accelerated compared to than without vibratory treatment”, “wherein formation of bone spicules is accelerated in a region of the socket compared to than without vibratory treatment”, “wherein formation of bone spicules is increased in a region of the socket compared to than without vibratory treatment”, “wherein mineralization is accelerated in a region of the socket compared to than without vibratory treatment”, “wherein mineralization is increased in a region of the socket compared to than without vibratory treatment” and “wherein alveolar space is decreased in a region of the socket compared to than without vibratory treatment”.
Regarding claim 13, Implant Practice US teaches wherein a session time is from 30 seconds to 20 minutes (since the device could be used for 5 minutes per day, page 2 and page 4).
Regarding claim 14, Implant Practice US teaches where sessions are repeated daily, every other day, semi-weekly, or weekly (since the sessions could be repeated every day, page 2 and page 4).
Regarding claim 15, Implant Practice US discloses wherein the treatment period is from 1 day to 1 year (since the treatment period could be for 8 weeks, page 4).
Claims 2, 4-5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Implant Practice US and Kurtzman, as applied to claim 1 above, and further in view of Way (US 2020/0315745 A1).
Regarding claims 2 and 5, Implant Practice US and Kurtzman, as combined above, fail to disclose “wherein a vibrational frequency of the vibrational dental device is ranging from 45 Hz to 150 Hz” and “wherein the vibration frequency is about 113 Hz”.
Way discloses 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 frequency of the vibrational dental device is ranging from 45 Hz to 150 Hz” and “wherein the vibration frequency is about 113 Hz”; since the vibration unit is configured to deliver a vibration between about 30 Hz and about 200 Hz ([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 Implant Practice US/Kurtzman in order to use a device that delivers vibrational frequencies ranging from 30 Hz to 200 Hz, as taught by Way, since it has been demonstrated that devices that deliver High-frequency vibration (e.g. 30 Hz to 200 Hz) relieve oral pain and improve blood flow to tissues (Implant Practice US: Conclusion, page 5).
Regarding claim 4, Implant Practice US/Kurtzman fails to disclose the acceleration of the mouthpiece. However, Way discloses “wherein an acceleration of the mouthpiece ranged from 0.010 G to 0.15 G”; since the vibratory waveform can be delivered at an acceleration between 0.030 G and 0.200 G (Way: [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 Implant Practice US/Kurtzman 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]).
Regarding claim 16, Implant Practice US/Kurtzman fails to disclose determining if an actual frequency or acceleration is above or below a set frequency or the set acceleration and adjusting the actual frequency or actual acceleration. However, Way discloses “further comprising: determining if an actual frequency or acceleration is above or below a set frequency or the set acceleration while the mouthpiece is vibrated against an occlusal surfaces of the patient's teeth; and adjusting the actual frequency or actual acceleration based upon the determination”; since the device comprises a feedback vibration loop to determine whether the applied acceleration and/or frequency is too high or too low; in order to adjust the output to obtain the desired acceleration or frequencies at the mouthpiece 102 regardless of the dampening effect caused by interaction with the teeth (Way: [0067]). 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 Implant Practice US/Kurtzman in order to use a device that determines the actual frequency or acceleration and adjusts the actual frequency or actual acceleration based upon the determination, as taught by Way, since the feedback loop provides the desired acceleration or frequencies at the mouthpiece 102 regardless of the dampening effect caused by interaction with the teeth ([0067]).
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Implant Practice US/Kurtzman, as applied to claim 1 above, and further in view of Malinin et al (US 9610143 B2).
Regarding claims 17 and 20; Implant Practice US/Kurtzman discloses the invention substantially as claimed. Implant Practice US discloses that the graft material includes cancellous bone, but fails to specifically disclose “wherein the graft material includes demineralized cancellous allograft” and “wherein the graft material includes autograft material”.
Malinin, however, teaches a method of bone grafting comprising placing bone graft material in an extraction socket and around the surface of the implant (see col 4, lines 3-20). “Wherein the graft material includes demineralized cancellous allograft” (col 7, lines 15-36) and “wherein the graft material includes autograft material” (col 5, lines 53-67). Additionally, the graft material includes xenografts synthetics and a combination thereof (col 5, line 67). 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 Implant Practice US/Kurtzman with the teachings of Malinin, as such modification would promote osseointegration between the implant and bone, help fil gaps between the socket and implant and improve ridge augmentation (col 1, lines 40-45).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Implant Practice US and Kurtzman, as applied to claim 1 above, and further in view of Yaltirik (WO 2020242425 A1).
As per claim 18, Implant Practice US/Kurtzman fails to disclose “wherein the graft material includes autologous L-PRF”. However, Yaltirik discloses a dental preparation useful for application of grafts, dental implants (page 9, paragraph 2). Also, Yaltirik discloses the combination of L-PRF (Leukocyte and patelet-rich fibrin) and bone graft in order to repair a tooth extraction socket (page 12, lines 15-28). Therefore, Yaltirik discloses “wherein the graft material includes autologous L-PRF”; since the PRF plays an active role immune control and epithelial closure, which are crucial in healing and soft tissue maturation. Since it is taken from the patient (autologous), it has many advantages such as not causing allergic reactions, preparation in a short time and easily, no risk of disease transfer, control of inflammation and suppression of infection thanks to the leukocyte therein and cytokines secreted by them (page 2, lines 15-21). 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 Implant Practice US/Kurtzman with the teachings of Yaltirik in order to create a bone graft containing L-PRF; sin such modification would help the graft material to accelerate tissue healing (Yaltirik: page 7, lines 20-25).
Claims 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Implant Practice US in view of Kurtzman, further in view of Malinin, as evidenced by Dental Products Report.
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), comprising: obtaining a vibrational dental device by a patient (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, page 2 and page 4) having an implant placed in grafted bone graft material in an extraction socket (implant placement at Nos. 12 and 14 sites; please see the “Treatment Planning” section; Nos. 12 and 14 sites received bone graft material; see Extractions with hard tissue augmentation section).
Placing the mouthpiece (bite plate) over the dentition; applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period (VPro™ high-frequency vibration, oral device with a bite plane; used for 5 minutes per day to improve bone for future implants, page 2 and page 4); wherein the graft material is converted to mature bone faster than without vibratory treatment (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). However, Implant Practice US fails to disclose wherein bone graft material is placed around an exposed portion of a dental implant.
Implant Practice US fails to specifically disclose “applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period beginning immediately after placement of the implant” and “wherein bone graft material is placed around an exposed portion of a dental implant”.
Malinin teaches a method of preparing a bone graft of compressed dehydrated decalcified trabecular bone (Abstract). Also, Malinin discloses wherein bone graft material is placed around an exposed portion of a dental implant (since a graft material comprising compact cancellous bone or cortical bone allograft or xenograft is placed around the surface of the implant, col 4, lines 3-20). Wherein the graft material includes autograft material, col 5, lines 53-67). 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 Implant Practice US with the teachings of Malinin, in order to identify a patient having bone graft material placed around an exposed portion of a dental implant; since such modification would allow the use of the vibrational device use in the method of Implant Practice US to promote osteointegration between the implant and the native bone and help to fill gaps between the socket and the implant. Also, it would have been obvious to further modify the teachings of Implant Practice US with Malinin’s disclosure, in order to include different graft materials, such as d autografts, since such modification would provide reliable materials that would secure the graft by osteointegration, reducing the risk of rejection or infection.
Kurtzman discloses that methods for dental implant integration and accelerating graft conversion to alveolar bone by applying LMHFV to an implant site (page 10). 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 10). 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 beginning immediately after placement of the implant, since such modification can accelerate bone density surrounding the implants improving the expected clinical outcome in a shorter period than traditionally observed (page 10).
Regarding claim 21, Implant Practice US /Malinin/Kurtzman discloses the invention substantially as claimed. Malinin discloses wherein the graft material includes autograft material (Col 5, lines 53-67).
Alternatively, claims 1-2, 4-17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Way et al. (US 20200315745 A1), in view of Malinin (US 9610143 B2); as evidenced by Marquette University (NPL attached to the Office Action filed on 12/06/2022).
Regarding claim 1, Way discloses a method for accelerating graft conversion to alveolar bone (since Way teaches that the dental devices can be used for strengthening bone during dental implant procedures, such as after bone grafting [0091]). The Examiner notes that strengthening bone during dental implant procedures, such as after bone grafting would inevitably bring the result of accelerating the conversion of said graft into vital bone, specially via the application of a vibrational device. Additionally, the device of the prior art has the same structures, features and functionalities of the device used in the claimed method and it is used for the same period of time (i.e. the same frequencies).
Comprising: obtaining a vibrational dental device by a patient (Figure 1); wherein the vibrational dental device has a mouthpiece (102) 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 ([0015] and [0091]). However, Way fails to disclose “obtaining a vibrational dental device by a patient having an implant placed in grafted bone graft material in an extraction socket” and “beginning immediately after placement of the implant”.
Malinin teaches a method of preparing a bone graft of compressed dehydrated decalcified trabecular bone (Abstract). Also, Malinin discloses “a patient having an implant placed in grafted bone graft material in an extraction socket (since it is a method of preparing a bone graft to be used to repair a tooth extraction socket with a dental implant; see col 3, line 54 to col 4, line 20). Also, Malinin teaches “wherein the graft material includes demineralized cancellous allograft” (col 7, lines 15-36) and “wherein the graft material includes autograft material” (col 5, lines 53-67).
Way and Malinin are analogous to the claim invention, since they are directed to the same field of promoting alveolar bone growth or osteointegration. Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to have modified Way’s disclosure with the teachings of Malinin, in order to identify a patient having an implant placed in grafted bone graft material in an extraction socket, since such modification would allow the use of Way’s device to promote osteointegration and would allow for preservation of bone contours for dental implants, denture stability, soft tissue aesthetics and maintaining periodontal status of adjacent teeth (see Malinin, citations above). Also, it would have been obvious to further modify the teachings of Way with Malinin’s disclosure, in order to include different graft materials, such as demineralized bone, cancellous bone and autografts; since such modification would provide reliable materials that would secure the graft by osteointegration, reducing the risk of rejection or infection.
By taking the combined teachings of Way and Malinin, as a whole, the combination teaches wherein the graft material is converted to mature bone faster than without vibratory treatment, since it is well known in the art that vibration therapy is beneficial for bone graft integration, as evidenced by Marquette University (page 9, paragraph 2). However, Way and Malinin, as combined above, fails to disclose “beginning immediately after placement of the implant”.
On the other hand, the Examiner notes that the Applicant clarifies in page 12 of the Remarks that the phrase “beginning immediately after placement of the implant” refers to a clinical timescale, and not an absolute one. In other words, vibration is not applied the instant the surgeon completes an implantation procedure, but rather as soon as possible after surgical recovery, as would be understood by one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Way/Malinin’s method to add the step of beginning immediately after placement of the implant, since such modification would be a case of "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (i.e. beginning as soon as a Doctor determines that the patient has recovered enough; see MPEP 2143).
Regarding claims 2 and 5, Way and Malinin teaches the invention substantially as claimed. Way discloses wherein a vibrational frequency of the vibrational dental device is ranging from 45 Hz to 150 Hz and wherein the vibration frequency is about 113 Hz (since the vibration unit is configured to deliver a vibration between about 30 Hz and about 200 Hz [0012]).
Regarding claim 4, Way and Malinin teaches the invention substantially as claimed. Way discloses wherein an acceleration of the mouthpiece ranged from 0.010 G to 0.15 G (since the vibratory waveform can be delivered at an acceleration between 0.030 G and 0.200 G [0012]).
Regarding claims 6-12, The Examiner notes that Way and Malinin discloses all the limitations as claimed, since Way discloses a device that could be used for strengthening bone during dental implant procedures, such as after bone grafting ([0091]). Also, Way discloses that its device delivers a vibration frequency and a magnitude of acceleration having overlapping ranges with those of the claimed invention ([0012]). Additionally, Way’s device has the same structures as the device from the immediate application. The Examiner further notes that it is well known in the art that applying a low magnitude high frequency vibration (LMHFV) to a patient’s dentition promotes the biological mechanisms that promote bone growth, as evidenced by Marquette University (page 9, paragraph 2). Therefore, the Examiner notes that devices having the same structures and delivering the same parameters would create the same results, as it is the case of the prior art of record and the immediate application.
For the reasons provided above Way discloses wherein an infiltration of granulation tissue into a clot is enhanced compared to than without vibratory treatment, wherein a proliferation by epithelium into an extraction site is accelerated compared to than without vibratory treatment, wherein formation of bone spicules is accelerated in a region of the socket compared to than without vibratory treatment, wherein formation of bone spicules is increased in a region of the socket compared to than without vibratory treatment, wherein mineralization is accelerated in a region of the socket compared to than without vibratory treatment, wherein mineralization is increased in a region of the socket compared to than without vibratory treatment and wherein alveolar space is decreased in a region of the socket compared to than without vibratory treatment.
Regarding claim 13, Way and Malinin discloses the invention substantially as claimed. Way discloses wherein a session time is from 30 seconds to 20 minutes (since the device could be used for 10 minutes per day or less [0015]).
Regarding claim 14, Way and Malinin discloses the invention substantially as claimed. Way discloses where sessions are repeated daily, every other day, semi-weekly, or weekly (since the sessions could be repeated every day ([0015]).
Regarding claim 15, Way and Malinin discloses the invention substantially as claimed. Way discloses wherein the treatment period is from 1 day to 1 year (since the treatment period could be equal to 180 days or less). Additionally, Way teaches that the device can advantageously significantly decrease the time required for tightening of the periodontal ligament (from the average of six months to a year) and that the device could be use on a continuing basis to provide general tooth strengthening ([0091]).
Regarding claim 16, Way and Malinin discloses the invention substantially as claimed. Way discloses further comprising: determining if an actual frequency or acceleration is above or below a set frequency or the set acceleration while the mouthpiece is vibrated against an occlusal surfaces of the patient's teeth; and adjusting the actual frequency or actual acceleration based upon the determination (since the device comprises a feedback vibration loop to determine whether the applied acceleration and/or frequency is too high or too low; in order to adjust the output to obtain the desired acceleration or frequencies at the mouthpiece 102 regardless of the dampening effect caused by interaction with the teeth [0067]).
Regarding claims 17 and 20; Way and Malinin discloses the invention substantially as claimed. Malinin discloses wherein the graft material includes demineralized cancellous allograft (col 7, lines 15-36) and wherein the graft material includes autograft material (col 5, lines 53-67).
Regarding claim 19, Way discloses a method for accelerating graft conversion to alveolar bone (since the dental devices can be used for strengthening bone during dental implant procedures, such as after bone grafting [0091]), comprising: obtaining a vibrational dental device by a patient having a grafted bone graft material in an extraction socket ([0091]),; placing the mouthpiece (102) over the dentition; applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period ([0091]). However, Way fails to disclose “a patient having an implant placed in grafted bone graft material in an extraction socket”, “wherein bone graft material is placed around an exposed portion of a dental implant” and “beginning immediately after placement of the implant”.
Malinin teaches a method of preparing a bone graft of compressed dehydrated decalcified trabecular bone (Abstract). Also, Malinin discloses “a patient having an implant placed in grafted bone graft material in an extraction socket (since it is a method of preparing a bone graft to be used to repair a tooth extraction socket with a dental implant; see col 3, line 54 to col 4, line 20). Also, Malinin teaches “wherein bone graft material is placed around an exposed portion of a dental implant” (col 7, lines 15-36). Also, Malinin teaches “wherein the graft material includes demineralized cancellous allograft” (col 7, lines 15-36) and “wherein the graft material includes autograft material” (col 5, lines 53-67).
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 Way with the teachings of Malinin, in order to identify a patient having bone graft material placed around an exposed portion of a dental implant, since such modification would allow the use of the vibrational device use in the method of Implant Practice US to promote osteointegration between the implant and the native bone and help to fill gaps between the socket and the implant. Also, it would have been obvious to further modify the teachings of Way with Malinin’s disclosure, in order to include different graft materials, such as demineralized bone, cancellous bone and autografts; since such modification would provide reliable materials that would secure the graft by osteointegration, reducing the risk of rejection or infection.
By taking the combined teachings of Way and Malinin, as a whole, the combination teaches wherein the graft material is converted to mature bone faster than without vibratory treatment, since it is well known in the art that vibration therapy is beneficial for bone graft integration, as evidenced by Marquette University (page 9, paragraph 2). However, Way and Malinin, as combined above, fails to disclose “beginning immediately after placement of the implant”.
On the other hand, the Examiner notes that the Applicant clarifies in page 12 of the Remarks that the phrase “beginning immediately after placement of the implant” refers to a clinical timescale, and not an absolute one. In other words, vibration is not applied the instant the surgeon completes an implantation procedure, but rather as soon as possible after surgical recovery, as would be understood by one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Way/Malinin’s method to add the step of beginning immediately after placement of the implant, since such modification would be a case of "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (i.e. beginning as soon as a Doctor determines that the patient has recovered enough; see MPEP 2143).
Regarding claim 21, Way and Malini discloses “wherein the graft material includes autograft material” (Malinin: Col 5, lines 53-67).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Way in view of Malinin, further in view of Yaltirik (WO 2020242425 A1, see original document attached to the Office Action filed on 12/06/2022).
As per claim 18, Way and Malinin, as combined above, fails to disclose wherein the graft material includes autologous L-PRF. However, Yaltirik discloses a dental preparation useful for application of grafts, dental implants (page 9, paragraph 2). Also, Yaltirik discloses the combination of L-PRF (Leukocyte and patelet-rich fibrin) and bone graft in order to repair a tooth extraction socket (page 12, lines 15-28). Therefore, Yaltirik discloses wherein the graft material includes autologous L-PRF; since Yaltirik teaches that PRF plays an active role immune control and epithelial closure, which are crucial in healing and soft tissue maturation. Since it is taken from the patient (autologous), it has many advantages such as not causing allergic reactions, preparation in a short time and easily, no risk of disease transfer, control of inflammation and suppression of infection thanks to the leukocyte therein and cytokines secreted by them (page 2, lines 15-21). Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to have modified Way/Malinin’s method with the teachings of Yaltirik in order to create a bone graft containing L-PRF, since such modification would help the graft material to accelerate tissue healing (page 7, lines 20-25).
Conclusion
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/LUIS RUIZ MARTIN/
Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772