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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/15/2024 was filed after the mailing date of the application on 05/01/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 6 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Interpretation
Claims 1 and 10 recite “providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period; wherein the graft material is converted to mature bone faster than without vibratory treatment”, these limitations constitute printed matter and have no patentable weight (please see MPEP 2111.05). The broadest reasonable interpretation has been applied to these limitations and they are determined not to be part of the claimed method for converting osseous graft to vital bone; since said limitations are in fact directed to printed matter (i.e. said limitations claim only the content of information; See In re DiStefano, 808 F.3d 845, 848, 117 USPQ2d 1265, 1267 (Fed. Cir. 2015) or to verbal instructions. Additionally, said printed matter does not present a new and nonobvious functional relationship with the known method (i.e. the method for converting osseous graft to vital bone); please see King Pharmaceuticals Inc. v. Eon Labs Inc., 616 F.3d 1267, 1279, 95 USPQ2d 1833, 1842 (Fed. Cir. 2010). The Examiner notes that said steps included in the printed matter could be printed matter in a different method other than for converting osseous graft to vital bone. For instance, they could be printed matter in a method for strengthening native alveolar bone or in a method for strengthening bone during and after dental implant procedures without bone grafts.
Rejections based 35 U.S.C. 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. In accordance with the “2019 Revised Patent Subject Matter Eligibility Guidance,” issued January 7, 2019 the pending claims are analyzed as follows —
Step 1 - In regard to claims 1-10 directed to “A method for converting osseous graft to vital bone, comprising: identifying a patient having oral bone graft material; providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition; and providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period; wherein the graft material is converted to mature bone faster than without vibratory treatment. And to “A method for accelerating graft conversion to alveolar bone, comprising: identifying a patient having bone graft material placed around an exposed portion of a dental implant, and one or more teeth comprising the patient's dentition; providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition and/or the dental implant; and providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period; wherein the graft material is converted to mature bone faster than without vibratory treatment”. The “methods” are within the 35 U.S.C. 101 statutory category of a “process” (MPEP 2106.03), but falls into the judicial exception (MPEP 2106.04).
Step 2A —In regard to claims 1-10, the claimed invention is directed to an abstract idea (MPEP 2106.04(a)) without reciting additional elements that amount to significantly more than the judicial exception (MPEP 2106.05). The claimed invention is directed to a mental process — concepts that are capable of being performed in the human mind — including observations, evaluations and judgements. More particularly, the steps of “identifying a patient having oral bone graft material; providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition; and providing instructions for using the vibrational dental device” are capable of being done mentally (e.g. a dentist views a patient’s dentition envisioning a 3D image of the structure or any other type of medical image, which is stored digitally in a computer memory and identifies a patient having oral bone graft material from a set of patient’s images stored in the memory); the steps of “providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition; and providing instructions for using the vibrational dental device”; may be done mentally or abstractly via a prescription (e.g. the dentist prescribes instructions after identifying a patient). It is further noted that dentists have long practiced their trade/art of determining mentally what prescriptions/instructions are needed for dental treatments and are most certainly capable of envisioning and mentally said instructions and identifying patient’s conditions. Additionally, there are no additional elements positively recited that integrate the exception into a practical application, i.e. placing and using the mouthpiece in the dentition. For instance, placing the mouthpiece over the dentition; applying an axial vibratory force during a predetermined number of sessions throughout a predetermined treatment period.
Step 2B — In regard to claims 1-10, the claimed steps are capable of being performed mentally and represent nothing more than concepts related to performing mathematical/metal/algorithmic calculations/steps which fall within the judicial exception. The claims do not go beyond “determining” and “calculating” steps based on a standard generic abstract ideas of one of skills in the art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 10 recite “A method for converting osseous graft to vital bone”; however, it is unclear how the steps that are positively recited in the claim would accomplish said converting osseous graft to vital bone. The scope of the claim is indefinite. The Examiner notes that none of the steps belonging to said method provide any action or procedure that would actually convert osseous graft to vital bone. The steps of “identifying a patient having oral bone graft material; providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition”; do not constitute an action that would converting osseous graft to vital bone. Even the step of “providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition” does not constitute an action that would converting osseous graft to vital bone; since it does not positively recite the action of actually using said vibrational dental device. The Examiner notes that the rest of the limitations in the claims, which recite steps that would converting osseous graft to vital bone, constitute printed matter and have no patentable weight (please see the Claim Interpretation section above). Additionally, none of the limitations recited as part of the printed matter have a new and nonobvious functional relationship with the known method for converting osseous graft to vital bone.
Note for the Applicant: If it is Applicant’s intention to linked the steps recited as part of the printed matter with the claimed method for converting osseous graft to vital bone, said steps should be positively recited as part of the method.
Claim 3 recites “wherein the duration is ranging from 30 seconds to 20 minutes”; there is a lack of antecedent basis for the term “duration” in the claims.
Claims 2, 4-9 are rejected by virtue of their dependency on claim 1.
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 1-10 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-2 and 4-21 of U.S. Patent Application No. 17/452,874, 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, the method for converting osseous graft to vital bone, comprising: identifying a patient having oral bone graft material; providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition; and providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined 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 1-10 in the immediate application have been analyzed and rejected with respect to claims 1-2 and 4-21 in the co-pending application. The instant application reads on the co-pending application based on the underline portion. 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 3 is rejected with respect to claim 13 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 6 is rejected with respect to claim 13 of the co-pending application.
Claim 7 is rejected with respect to claim 14 of the co-pending application.
Claim 8 is rejected with respect to claim 15 of the co-pending application.
Claim 9 is rejected with respect to claim 20 of the co-pending application.
Claim 10 is rejected with respect to claim 1 of the co-pending application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3 and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by High-Frequency vibration for normalizing tooth mobility and improving bone for implant: a case study (by Implant Practice US, hereinafter Implant Practice US’), as evidenced by Dental Products Report (please see PTO-892 and NPLs attached).
As per claim 1, Implant Practice US discloses a method for converting osseous graft to vital 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: Identifying a patient having oral bone graft material (since the method is performed after extracting teeth 12 and 14 of a patient, wherein bone graft material is placed in the sockets; Figure 4, section “Extraction with hard tissue augmentation”, 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). The Examiner notes that the VPro™ oral device has a mouthpiece as evidenced by Dental Products Report); and providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period (since the device is provided with instructions to use it 5 minutes per day for 8 weeks, section “Extraction with hard tissue augmentation”, 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).
The Examiner notes that said instructions (printed matter) are not functionally related to the structure of the vibrational dental device, therefore the claimed invention does not patentably distinguish from the prior art reference.
Regarding claim 3, Implant Practice US teaches wherein a treatment 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 6, Implant Practice US teaches wherein a treatment 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 7, 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 8, Implant Practice US teaches wherein the treatment period is from 1 day to 1 year (since the treatment period could be for 8 weeks, page 4).
Claim Rejections - 35 USC § 103
Alternatively, claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Way (US 20200315745 A1), in view of Malinin (US 9610143 B2), further in view of Way et al. (US 20200093574 A1), hereafter Way 3574; as evidenced by Marquette University (see NPL attached and the PTO 892 form).
Regarding claim 1, Way discloses a method for converting osseous graft to vital 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 converting said graft into vital bone. 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).
Way discloses a device configured to accommodate a patient’s full dentition (Figure 3C; [0012]). Therefore, Way discloses identifying a patient having one or more teeth comprising the patient's dentition (Figure 3C). Also, Way teaches providing to the patient a vibrational dental device (Figure 1) having a mouthpiece (102) for contacting the dentition ([0055]). Way further discloses using the device by placing the mouthpiece over the dentition and applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period (see [0015] and [0091]). Way discloses using the device on a patient after periodontal bone grafting ([0091]) which would necessarily require identifying a patient having oral bone graft material; otherwise, Malinin teaches this step as set forth below. However, Way fails to disclose ““providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period; wherein the graft material is converted to mature bone faster than without vibratory treatment”.
Malinin teaches a method of preparing a bone graft of compressed dehydrated decalcified trabecular bone (Abstract). Also, Malinin discloses identifying a patient having oral bone graft material (since it is a method of preparing a bone graft to be used to repair a tooth extraction socket, col 6, line 54 – col 7, line 14). Also, Malinin teaches 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 method with the teachings of Malinin, in order to identify a patient a patient having oral bone graft material, 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’s method, in order to include different graft materials, such as autografts, since such modification would provide reliable materials that would secure the graft by osteointegration, reducing the risk of rejection or infection. However, Way and Malinin, as combined above, fails to disclose “providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period; wherein the graft material is converted to mature bone faster than without vibratory treatment”.
On the other hand, Way 3574 teaches a vibrational dental device (Abstract). Way 3574 teaches providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period, since Way 3574 teaches a method for using a vibration dental device, which comprises providing instructions for using the device, such as the frequency in Hz that should be applied, as well as the amount of periods and treatment duration ([0006] – [008]). 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 Way 3574, in order to provide instructions for using the vibration device, since such modification would allow the patients to conveniently use the device at home without the supervision of a dental practitioner.
By taking the combined teachings of Way, Malinin and Way 3574, as a whole, Way, Malinin and Way 3574 discloses 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).
It is also noted that the instructions provided, under a broadest reasonable interpretation, are printed matter wherein the printed matter itself is not given patentable weight. Therefore, if, arguendo, the prior art does not teach/disclose the exact steps claimed, the printed matter is not given patentable weight and is therefore met by the prior art given that only the existence of instructions being provided is given patentable weight.
Regarding claims 2 and 5, Way, Malinin and Way 3574 discloses the invention substantially as claimed. Way discloses wherein the frequency is ranging from 45 Hz to 150 Hz and wherein the 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 claims 3, Way, Malinin and Way 3574 discloses the invention substantially as claimed. Way discloses wherein the duration is ranging from 30 seconds to 20 minutes (since the device could be used for 10 minutes per day or less ([0015]).
Regarding claims 4, Way, Malinin and Way 3574 discloses the invention substantially as claimed. Way discloses wherein the 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, Way, Malinin and Way 3574 discloses the invention substantially as claimed. Way discloses wherein the session time is from 30 seconds to 20 minutes (since the device could be used for 10 minutes per day or less ([0015]).
Regarding claims 7, Way, Malinin and Way 3574 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 claims 8, Way, Malinin and Way 3574 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 claims 9, Way, Malinin and Way 3574 discloses the invention substantially as claimed. Malinin discloses wherein the bone graft is autograft (col 5, lines 53-67).
Regarding claim 10, Way teaches 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]). Way discloses a device configured to accommodate a patient’s full dentition (Figure 3C; [0012]). Therefore, Way discloses identifying a patient having one or more teeth comprising the patient's dentition (Figure 3C). Also, Way teaches providing to the patient a vibrational dental device (Figure 1) having a mouthpiece (102) for contacting the dentition ([0055]). Way further discloses using the device by placing the mouthpiece over the dentition and applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period (see [0015] and [0091]). However, Way fails to disclose “identifying a patient having bone graft material placed around an exposed portion of a dental implant” and “providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period; wherein the graft material is converted to mature bone faster than without vibratory treatment”.
Malinin teaches a method of preparing a bone graft of compressed dehydrated decalcified trabecular bone (Abstract). Also, Malinin discloses identifying a patient having bone graft material placed around an exposed portion of a dental implant (since it is a method of preparing a bone graft to be used to repair a tooth extraction socket, col 6, line 54 – col 7, line 14, where an implant is placed, col 3, line 54 – col 4, line 20).
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 method with the teachings of Malinin, in order to identify a patient a patient having oral bone graft material, 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). However, Way and Malinin, as combined above, fails to disclose “providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period; wherein the graft material is converted to mature bone faster than without vibratory treatment”.
On the other hand, Way 3574 teaches a vibrational dental device (Abstract). Way 3574 teaches providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period, since Way 3574 teaches a method for using a vibration dental device, which comprises providing instructions for using the device, such as the frequency in Hz that should be applied, as well as the amount of periods and treatment duration ([0006] – [008]). 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 Way 3574, in order to provide instructions for using the vibration device, since such modification would allow the patients to conveniently use the device at home without the supervision of a dental practitioner.
By taking the combined teachings of Way, Malinin and Way 3574, as a whole, Way, Malinin and Way 3574 discloses 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).
Claims 2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Implant Practice US as applied to claim 1 above, and further in view of Way (US 2020/0315745 A1).
Regarding claims 2 and 5, Implant Practice US fails 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 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 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 [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 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 9-10 is rejected under 35 U.S.C. 103 as being unpatentable over Implant Practice US as applied to claim 1 above, and further in view of Malinin (US 9610143 B2), as evidenced by Dental Products Report.
Regarding claim 9, Implant Practice US discloses that the graft material includes cancellous bone, but fails to specifically disclose “wherein the bone graft is autograft”.
Manlinin, 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 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).
Regarding claim 10, Implant Practice US teaches 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: identifying a patient having bone graft material placed in the oral cavity, and one or more teeth comprising the patient's dentition (since the method is performed after extracting teeth 12 and 14 of a patient, wherein bone graft material is placed in the sockets, Figure 4, section “Extraction with hard tissue augmentation”, page 4); providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition and/or the dental implant (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). The Examiner notes that the VPro™ oral device has a mouthpiece as evidenced by Dental Products Report); and providing instructions for using the vibrational dental device, the instruction comprising: placing the mouthpiece over the dentition; applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period (since the device is provided with instructions to use it 5 minutes per day for 8 weeks, section “Extraction with hard tissue augmentation”, page 4). The Examiner notes that said instructions (printed matter) are not functionally related to the structure of the vibrational dental device, therefore claimed invention does not patentably distinguish from the prior art reference. 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 specifically disclose “identifying a patient having bone graft material 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 identifying a patient having bone graft material placed around an exposed portion of a dental implant, and one or more teeth comprising the patient's dentition (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). 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS MIGUEL RUIZ MARTIN whose telephone number is (571)270-0839. The examiner can normally be reached M-F 8 Am - 5 PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUIS RUIZ MARTIN/
Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772