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, see Remarks filed on 06/05/2026, 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.
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; and wherein osseointegration of the implant and conversion of the graft material to mature bone occur concurrently during the treatment period.; 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 1-2, 4-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Teixeira (US 20190239992 A1) as evidenced by Marquette University.
Regarding claim 1, Teixeira teaches an embodiment of a method for accelerating bone healing (Abstract), comprising: obtaining a vibrational dental device by a patient having an implant placed in an extraction socket (since it is a method where vibrating bite plate or mouthpiece is applied to the dentition [0040], , wherein the subject has an implant and the method improve bone-implant reaction (osteointegration), which shortens the period that currently clinicians need to wait until quality of bone around implant improves enough to support loading [0035]); wherein the vibrational dental device has a mouthpiece for contacting the dentition of the patient (Figure 3 and [0060]); placing the mouthpiece over the dentition; applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period ([0060]); wherein the graft material is converted to mature bone faster than without vibratory treatment (since Teixeira’s device applies a high frequency with low magnitude force, vibrational treatments are well known in the art to contribute to graft integration and recovery after dental extortions; as evidenced by Marquette University, page 9, paragraph 2).
Teixeira teaches an additional embodiment of a patient having graft material in an extraction socket ([0036]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to combine Teixeira’s methods to create a complete method for accelerating graft conversion to alveolar bone by a patient having an implant placed in grafted bone graft material in an extraction socket, since such modification can increase bone density when combining graft material and implants to increase the chance of bone formation and a successful result. This physiological stimulation will create a milieu for bone forming cells to express maximum osteogenic effect ([0015]).
Therefore, Teixeira’s combined embodiments disclose “wherein osseointegration of the implant and conversion of the graft material to mature bone occur concurrently during the treatment period ([0035] and [0036]).
Teixeira teaches repeated on a daily basis over the plurality of treatment sessions (Teixeira: [0061]),but fails to specifically teach “beginning immediately after placement of the implant”.
However, there are a limited number of identifiable options to the period of time – that beign either applying vibratory treatment immediately or waiting a period of time. it would have been obvious to one of ordinary skills in the art to try applying the LMHFV beginning immediately after placement of the implant (e.g. 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 (or immediately) to shorten the time it takes for achieving implant/graft success.
Regarding claim 2, Teixeira teaches wherein a vibrational frequency of the vibrational dental device is ranging from 45 Hz to 150 Hz ([0028]).
Regarding claim 4, Teixeira teaches wherein an acceleration of the mouthpiece ranged from 0.010 G to 0.15 G ([0028]).
Regarding claim 5, Teixeira teaches wherein the vibration frequency is about 113 Hz ([0028]).
Regarding claims 6-12, The Examiner notes that Teixeira teaches all the limitations as claimed. Since Teixeira’s method includes the steps of converting graft material to mature bone. The Examiner further notes that it is well known in the art that applying a high frequency - low magnitude vibration to a patient’s dentition promotes the biological mechanisms that promote bone growth ([0035]). 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 Teixeira 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, Teixeira teaches wherein a session time is from 30 seconds to 20 minutes ([0061]).
Regarding claim 14, Teixeira teaches where sessions are repeated daily, every other day, semi-weekly, or weekly ([0061]).
Regarding claim 15, Teixeira teaches wherein the treatment period is from 1 day to 1 year ([0061]).
Regarding claim 19, Teixeira teaches a method for accelerating bone healing (Abstract), comprising: obtaining a vibrational dental device by a patient having an implant placed in an extraction socket (since it is a method where vibrating bite plate or mouthpiece is applied to the dentition [0040], \, wherein the subject has an implant and the method improve bone-implant reaction (osteointegration), which shortens the period that currently clinicians need to wait until quality of bone around implant improves enough to support loading [0035]), wherein bone graft material is placed around an exposed portion of a dental implant (since the subject had dental surgery and the physiologic stimulation of the invention will improve the healing process of bone after grafting, the site being e.g., tooth extractions [0036]; wherein the subject has an oral implant [0035] and claim 8); placing the mouthpiece over the dentition; applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period ([0060]); wherein the graft material is converted to mature bone faster than without vibratory treatment (since Teixeira’s device applies a high frequency with low magnitude force, vibrational treatments are well known in the art to contribute to graft integration and recovery after dental extortions; as evidenced by Marquette University, page 9, paragraph 2).
Teixeira teaches an additional embodiment of a patient having graft material in an extraction socket ([0036]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to combine Teixeira’s methods to create a complete method for accelerating graft conversion to alveolar bone by a patient having an implant placed in grafted bone graft material in an extraction socket, since such modification can increase bone density when combining graft material and implants to increase the chance of bone formation and a successful result. This physiological stimulation will create a milieu for bone forming cells to express maximum osteogenic effect ([0015]).
Therefore, Teixeira’s combined embodiments disclose “wherein osseointegration of the implant and conversion of the graft material to mature bone occur concurrently during the treatment period ([0035] and [0036]).
Teixeira teaches repeated on a daily basis over the plurality of treatment sessions (Teixeira: [0061]),but fails to specifically teach “beginning immediately after placement of the implant”.
However, it would have been obvious to one of ordinary skills in the art to try applying the LMHFV beginning immediately after placement of the implant (e.g. 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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Teixeira in view of Way (US 2020/0315745 A1).
Regarding claim 16, Teixeira fails to disclose “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”.
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]). 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 Teixeira 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 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Teixeira, as applied to claim 1 above, and further in view of Malinin et al (US 9610143 B2).
Regarding claims 17, 20 and 21, Teixeira teaches the invention substantially as claimed. Teixeira teaches 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 Teixeira 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 Teixeira, as applied to claim 1 above, and further in view of Yaltirik (WO 2020242425 A1).
As per claim 18, Teixeira 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 Teixeira 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 (Yaltirik: page 7, lines 20-25).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 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
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