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 05/29/2026, 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 1-10 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 at a graft site; providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition; placing the mouthpiece over the dentition such that the mouthpiece contacts the dentition; and operating the vibrational dental device to apply a vibratory force to the dentition during a predetermined number of sessions throughout a predetermined treatment period to convert the graft material to mature, vital bone faster than without vibratory treatment; wherein the graft material comprises a scaffold comprising a blood clot and a membrane, and wherein the converted mature, vital bone includes osteocytes present in lacunae at the graft site; 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. 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 § 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.
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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teixeira (US 20190239992 A1) in view of Elian (US 20200086000 A1), as evidenced by ScienceDirect (see the NPL attached amd The PTO 892 form).
Regarding claim 1, Teixeira teaches a method for converting osseous graft to vital bone (Abstract), comprising: identifying a patient having oral bone graft material at a graft site (since the subject had dental surgery and the physiologic stimulation of the invention will improve the healing process of bone after grafting [0036]); providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition ([0040]); placing the mouthpiece over the dentition such that the mouthpiece contacts the dentition; and operating the vibrational dental device to apply a vibratory force to the dentition during a predetermined number of sessions throughout a predetermined treatment period ([0060]) to convert the graft material to mature, vital bone faster than without vibratory treatment (since the applied High Frequency, Low Magnitude Forces increase bone osteogenic activity [0071]). And wherein the converted mature, vital bone includes osteocytes present in lacunae at the graft site (since necessarily mature vital bone contains osteocytes present in lacunae, as evidenced by ScienceDirect: “osteocytes are bone cells embedded in lacunae within the mineralized bone matrix”).
However, Teixeira fails to disclose “wherein the graft material comprises a scaffold comprising a blood clot and a membrane”.
Elian teaches a method for converting osseous graft to vital bone (Abstract), comprising: bone graft material at a graft site ([0146]); wherein the graft material comprises a scaffold (the three-dimensional carrier matrix, 3D printed [0145]) comprising a blood clot (since the graft contains growth factor composition comprises a platelet-rich fibrin (PRF) prepared from whole blood without adding any additives [0361] and because blood is collected without any anticoagulant and immediately centrifuged, a natural coagulation process then occurs and allows for the easy collection of a leucocyte- and platelet-rich fibrin (L-PRF) clot, without the need for any biochemical modification of the blood, that is, no anticoagulants [0363]) and a membrane (see amnion membrane [0145]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Teixeira’s method to add to the graft material a scaffold comprising a blood clot and a membrane, since such modification would add a structure to the graft and platelet-rich fibrin (L-PRF) clot, without the need for any biochemical modification of the blood ([0363]).
Regarding claim 2, Teixeira and Elian, as combined above, teach the invention substantially as claimed. Teixeira teaches wherein the frequency is ranging from 45 Hz to 150 Hz ([0009]).
Regarding claim 3, Teixeira and Elian, as combined above, teach the invention substantially as claimed. Teixeira teaches wherein the session time is ranging from 30 seconds to 20 minutes (e.g., 5 minutes [0061]).
Regarding claim 4, Teixeira and Elian, as combined above, teach the invention substantially as claimed. Teixeira teaches wherein the acceleration of the mouthpiece ranged from 0.010 G to 0.15 G ([0028]).
Regarding claim 5, Teixeira and Elian, as combined above, teach the invention substantially as claimed. Teixeira teaches wherein the frequency is about 113 Hz ([0028]).
Regarding claim 6, Teixeira and Elian, as combined above, teach the invention substantially as claimed. Teixeira teaches wherein the session time is from 30 seconds to 20 minutes ([0061]), and wherein the vibratory force is applied through the dentition to stimulate bone remodeling at the graft site to promote osteogenesis (since Teixeira treatment increased osteogenesis [0080]).
Regarding claim 7, Teixeira and Elian, as combined above, teach the invention substantially as claimed. Teixeira teaches where sessions are repeated daily, every other day, semi-weekly, or weekly ([0061]).
Regarding claim 8, Teixeira and Elian, as combined above, teach the invention substantially as claimed. Teixeira teaches wherein the treatment period is from 1 day to 1 year ([0061]).
Regarding claim 9, Teixeira and Elian, as combined above, fail to disclose “wherein the bone graft is autograft”.
Elian further teaches wherein the bone graft is autograft (e.g. autologous fibroblasts and autologous cells [0145]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Teixeira’s method to add to the graft material comprises autograft, since such modification would aid in the success of the graft.
Regarding claim 10, Teixeira teaches a method for accelerating graft conversion to alveolar bone (Abstract), comprising: identifying a patient having bone graft material placed at a graft site around an exposed portion of a dental implant, and one or more teeth comprising the patient's dentition (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); providing to the patient a vibrational dental device having a mouthpiece for contacting the dentition ([0040]) and/or the dental implant; placing the mouthpiece over the dentition such that the mouthpiece contacts the dentition; and operating the vibrational dental device to apply a vibratory force to the dentition and/or the dental implant during a predetermined number of sessions throughout a predetermined treatment period ([0060]) to convert the graft material to mature bone faster than without vibratory treatment (since the applied High Frequency, Low Magnitude Forces increase bone osteogenic activity [0071]); and wherein the converted mature, vital bone includes osteocytes present in lacunae at the graft site (since necessarily mature vital bone contains osteocytes present in lacunae, as evidenced by ScienceDirect: “osteocytes are bone cells embedded in lacunae within the mineralized bone matrix”).
However, Teixeira fails to disclose “wherein the graft material comprises a scaffold surrounding the dental implant, the scaffold comprising a blood clot and a membrane”.
Elian teaches a method for converting osseous graft to vital bone (Abstract), comprising: bone graft material at a graft site ([0146]) wherein the graft site is the location of a dental implant ([0146]); wherein the graft material comprises a scaffold (the three-dimensional carrier matrix, 3D printed [0145]) surrounding the dental implant ([0149]) the scaffold comprising a blood clot (since the graft contains growth factor composition comprises a platelet-rich fibrin (PRF) prepared from whole blood without adding any additives [0361] and because blood is collected without any anticoagulant and immediately centrifuged, a natural coagulation process then occurs and allows for the easy collection of a leucocyte- and platelet-rich fibrin (L-PRF) clot, without the need for any biochemical modification of the blood, that is, no anticoagulants [0363]) and a membrane (see amnion membrane [0145]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Teixeira’s method to add to the graft material a scaffold surrounding the dental implant, comprising a blood clot and a membrane, since such modification would add a structure to the graft and platelet-rich fibrin (L-PRF) clot, without the need for any biochemical modification of the blood ([0363]).
Regarding claims 11 and 13, Teixeira and Elian, as combined above, teach the invention substantially as claimed. Elian teaches wherein the membrane is a resorbable membrane (since it is an amnion membrane [0145]).
Regarding claims 12 and 14, Teixeira and Elian, as combined above, teach the invention substantially as claimed. Elian teaches wherein the resorbable membrane is an amnion- chorion membrane ([0145]).
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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