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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the concave top surface in claim 10 must be shown or the feature(s) canceled from the claim(s). As concave means an inward curvature where the middle portion is thinner than the edge portions, part 16 in figures 2 -4 is not concave. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 8-11, and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spagnoli (US Pub No.: 2010/0217331).
Regarding claim 1, Spagnoli (US Pub No.: 2010/0217331) discloses a screw for maintaining space during a bone augmentation procedure (in the abstract, screws shown in figure 1 and 3)), the screw comprising: a head having a top surface configured to support a dental membrane (being contoured head 110); a shaft extending from a bottom surface of the head (shown in figures 1 and 3 as parts 140 and 340 respectively), as least a portion of the shaft having threads (threads on a shaft in [0028], shown in figures 1 and 3); and a tip (the tip 150 and 350 in figures 1 and 3), wherein the screw is formed from bone material (cortical bone and hydroxyapatite disclosed in [0070]).
Regarding claim 2, Spagnoli discloses the screw of claim 1, wherein the bone material is selected from one of allograft and xenograft (as cortical bone is present in [0070], a xenografted source of a material is implied).
Regarding claim 3, Spagnoli discloses the screw of claim 1, wherein the bone material is an artificial bone material that has characteristics of cortical bone (disclosed in [0070]).
Regarding claim 8, Spagnoli discloses the screw of claim 1, wherein the portion of the shaft that includes the threads is the entire shaft (in figure 1).
Regarding claim 9, Spagnoli discloses the screw of claim 1, wherein the portion of the shaft that includes the threads is about 75 percent (%) of a total length of the shaft (as per [0055], the “the threading initiates at the tip but stops at some point prior to reaching the head.” As such, Spagnoli teaches ranges of threads other than in instances when the threading extends across the entirety of the shaft).
Regarding claim 10, Spagnoli discloses a support screw for maintaining space during a bone augmentation procedure (in the abstract), the screw comprising: a head (part 110 in figure 1 as per [0040) having a concave top surface (bi-concave surface by part 210 in figure [0038]) configured to support a dental membrane (fixating membranes in [0047], Dental disclosure in [0001]-[0003]), the head comprising an engagement bore configured to engage with a tool to insert the support screw into patient bone (being the opening shown in figure 2, with projections disclosed in [0038]); a shaft extending from a bottom surface of the head (part 140 in figure 1), as least 50 percent (%) of the shaft having threads (shown visually in figure 1, full threading in [0032]); and a tip configured to engage the patient bone (figure 1 part 150), wherein the support screw is formed from bone material (cortical bone and hydroxyapatite disclosed in [0070]).
Regarding claim 11, Spagnoli discloses the support screw of claim 10, wherein the bone material is selected from one of allograft and xenograft (as cortical bone is present in [0070], a xenografted source of a material is implied).
Regarding claim 14, Spagnoli discloses a method of performing a bone augmentation procedure (bone grafting procedure in the abstract, method in [0006]), the method including: installing a screw into a bone of the patient along a surgical site (implanting of a screw into a jawbone in [0006]), the screw including: a head (part 110 in figure 1 as per [0040) having a top surface configured to support a dental membrane (fixating membranes in [0047], Dental disclosure in [0001]-[0003]), a shaft extending from a bottom surface of the head (part 140 in figure 1), as least a portion of the shaft having threads (shown visually in figure 1, full threading in [0032]); and a tip (figure 1 part 150), wherein the screw is formed from bone material(cortical bone and hydroxyapatite disclosed in [0070]); securing a dental membrane to the bone of the patient such that a head of the screw supports the dental membrane (as a fixation of a membrane is disclosed in [0047], the screw device of Spagnoli that includes head part 110 will also support a membrane. Support of a soft tissue 570 present in figure 5); and packing the space between the bone, the dental membrane, and the screw with bone grafting material (part 450 in figure 4 is disclosed as being bone growth material in [0046]. As bone grafting material is used to promote a bone growth, part 450 is considered to be equivalent to a bone grafting material. Mesh part 550 in figure 5 is also considered to be equivalent to a bone grafting material).
Regarding claim 15, Spagnoli discloses the method of claim 14, wherein the bone material is selected from one of allograft and xenograft (as cortical bone is present in [0070], a xenografted source of a material is implied).
Regarding claim 16, Spagnoli discloses the method of claim 14, wherein the bone material is an artificial bone material that has characteristics of cortical bone (disclosed in [0070]).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 4 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spagnoli (US Pub No.: 2010/0217331) in view of Vickers (US Pub No.: 2017/0333190).
Regarding claim 4, Spagnoli discloses the screw of claim 3. However, Spagnoli does not teach wherein the screw has a porosity of about 5 percent (%) to about 10%.
Instead, Vickers discloses wherein the screw has a porosity of about 5 percent (%) to about 10% (porosity of particles within this range in [0077], wherein the particles are part of an osteoimplants with a dental usage disclosed in [0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the particles of Vickers into Spagnoli for the purpose of providing particles used detailed in [0028] and [0062], where said porosity will allow for a bone growth in [0122].
Regarding claim 17, Spagnoli discloses the screw of claim 14. However, Spagnoli does not teach wherein the screw has a porosity of about 5 percent (%) to about 10%.
Instead, Vickers discloses wherein the screw has a porosity of about 5 percent (%) to about 10% (porosity of particles within this range in [0077], wherein the particles are part of an osteoimplants with a dental usage disclosed in [0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the particles of Vickers into Spagnoli for the purpose of providing particles used detailed in [0028] and [0062], where said porosity will allow for a bone growth in [0122].
Claim(s) 5 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spagnoli (US Pub No.: 2010/0217331) in view of Pillar (US Patent No.: 5,344,457).
Regarding claim 5, Spagnoli discloses the screw of claim 3. However, Spagnoli does not teach wherein the screw has a pore diameter of about 10 microns ( µm) to about 50 µm.
Instead, Pillar (US Patent No.: 5,344,457) teaches wherein the screw has a pore diameter of about 10 microns ( µm) to about 50 µm (in column 5 lines 52-67 into column 6 lines 1-9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the porosity ranges presented in Pillar into Spagnoli for the purpose of providing a varying porosity on an implant to allow for an ingrowth as per 5 lines 52-67 to column 6 lines 1-9.
Regarding claim 18, Spagnoli discloses the screw of claim 14. However, Spagnoli does not teach wherein the screw has a pore diameter of about 10 microns ( µm) to about 50 µm.
Instead, Pillar (US Patent No.: 5,344,457) teaches wherein the screw has a pore diameter of about 10 microns ( µm) to about 50 µm (in column 5 lines 52-67 into column 6 lines 1-9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the porosity ranges presented in Pillar into Spagnoli for the purpose of providing a varying porosity on an implant to allow for an ingrowth as per 5 lines 52-67 to column 6 lines 1-9.
Claim(s) 6-7, 13, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spagnoli (US Pub No.: 2010/0217331) in view of Sfeir (US Pub No.: 2023/0094767).
Regarding claim 6, Spagnoli discloses the screw of claim 1. However, Spagnoli does not teach wherein the porosity of the screw changes along a longitudinal axis of the screw.
Instead, Sfeir teaches wherein teaches wherein the porosity of the screw changes along a longitudinal axis of the screw (a porosity gradient along a bone screw is disclosed in [0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the difference in porosities throughout the screw shaft and screw head, as presented in [0032] of Sfeir into Spagnoli for the purpose of providing a means for controlling the resorption rates of parts of the implanted screw (in [0032]).
Regarding claim 7, Spagnoli discloses the screw of claim 1. However, Spagnoli does not teach wherein the shaft has a porosity that is different from the porosity of the head of the screw.
Sfeir (US Pub No.: 2023/0094767) teaches wherein the shaft has a porosity that is different from the porosity of the head of the screw (in [0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the difference in porosities throughout the screw shaft and screw head, as presented in [0032] of Sfeir into Spagnoli for the purpose of providing a means for controlling the resorption rates of parts of the implanted screw (in [0032]).
Regarding claim 13, Spagnoli discloses the support screw of claim 10. However, Spagnoli does not teach wherein the shaft has a porosity that is different from the porosity of the head of the screw.
Sfeir (US Pub No.: 2023/0094767) teaches wherein the shaft has a porosity that is different from the porosity of the head of the screw (in [0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the difference in porosities throughout the screw shaft and screw head, as presented in [0032] of Sfeir into Spagnoli for the purpose of providing a means for controlling the resorption rates of parts of the implanted screw (in [0032]).
Regarding claim 19, Spagnoli discloses the screw of claim 17. However, Spagnoli does not teach wherein the porosity of the screw changes along a longitudinal axis of the screw.
Instead, Sfeir teaches wherein teaches wherein the porosity of the screw changes along a longitudinal axis of the screw (a porosity gradient along a bone screw is disclosed in [0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the difference in porosities throughout the screw shaft and screw head, as presented in [0032] of Sfeir into Spagnoli for the purpose of providing a means for controlling the resorption rates of parts of the implanted screw (in [0032]).
Regarding claim 20, Spagnoli discloses the screw of claim 14. However, Spagnoli does not teach wherein the shaft has a porosity that is different from the porosity of the head of the screw.
Sfeir (US Pub No.: 2023/0094767) teaches wherein the shaft has a porosity that is different from the porosity of the head of the screw (in [0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the difference in porosities throughout the screw shaft and screw head, as presented in [0032] of Sfeir into Spagnoli for the purpose of providing a means for controlling the resorption rates of parts of the implanted screw (in [0032]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spagnoli (US Pub No.: 2010/0217331) in view of Drapeau (US Pub No.: 2017/0266347).
Regarding claim 12, Spagnoli teaches the support screw of claim 10. However, Spagnoli does not teach wherein the bone material is mineralized.
Instead, Drapeau (US Pub No.: 2017/0266347) teaches wherein the bone material Is mineralized (mineralized tissue in the abstract and [032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a mineralized material as presented in Drapeau into Spagnoli for the purpose of providing a bone material for a screw (screws in [0104] of Drapeau) that is disclosed as being osteoinductive as per [0076] which will stimulate a formation of new bone.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Althobity (US Pub No.: 2018/0333236) considered for screw like members for a denture in figure 8. Ali (US Pub No.: 2013/0280675) considered for screw details (579 in figure 6) that are inserted into a jaw bone.
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774