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 .
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) 44-47, 52, 59-62, 64, 68 are rejected under 35 U.S.C. 103 as being unpatentable over Masinaei et al (Pub. No.: US 2011/0045044) in view Vanderploeg et al (Pub. No.: US 2016/0184390).
Regarding claim 44, Masinaei et al disclose a method for preparing a composition comprising:
subjecting a non-demineralized cortical bone graft to a single incubation in an acid solution for no more than 300 seconds (4-5 minutes) [see 0127];
wherein the demineralized cortical bone graft has a residual calcium content of less than 6 wt % based on the dry weight of the demineralized cortical bone graft [see 0036, 0049];
combining cancellous bone particulate and the demineralized cortical bone graft [see 0007, 0057, 0067, 0069].
Masinaei et al disclose don’t disclose wherein the acid solution has a pH of 0-4, to provide a demineralized cortical bone graft,
Nonetheless, Vanderploeg et al disclose pH between 3.5 and 4.0 [see 0053].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Masinaei et al and Vanderploeg et al by using a pH between 3.5 and 4.0; Low pH compositions are often used in various applications due to their ability to effectively remove stains and improve whiteness such as improved removal of residues from fabrics and associated improvement in whiteness.
Regarding claim 45, Masinaei et al disclose wherein the non-demineralized cortical bone graft comprises cortical bone fibers, cortical bone particles, cortical bone sheets, cortical bone cubes, cortical bone shafts, or a combination thereof [see 0013, 0031, 0036, 0071]
Regarding claims 46, 52, Masinaei et al disclose Masinaei et al disclose wherein the non-demineralized cortical bone graft comprises non-demineralized cortical bone fibers, and wherein the demineralized cortical bone graft comprises demineralized cortical bone fibers [see 0013, 0031, 0036, 0071].
Regarding claim 47, Masinaei et al disclose wherein the non-demineralized cortical bone fibers have an average shortest dimension of less than 200 um [see 0076, 0112, 0127].
Regarding claim 59, Masinaei et al disclose method for preparing a composition comprising:
subjecting a non-demineralized cortical bone graft to a single incubation in an acid solution for no more than 300 seconds (4-5 minutes) [see 0127] to provide demineralized cortical bone graft,
the demineralized cortical bone graft has a residual calcium content of less than 6 wt % based on the dry weight of the demineralized cortical bone graft [see 0036, 0049];
combining cancellous bone particulate and the demineralized cortical bone graft [see 0007, 0057, 0067, 0069];
storing the cancellous bone particulate and the demineralized cortical bone graft in glycerol [see 0011, 0014, 0018, 0028].
Masinaei et al disclose don’t disclose wherein the acid solution has a pH of 0-4, to provide a demineralized cortical bone graft,
Nonetheless, Vanderploeg et al disclose pH between 3.5 and 4.0 [see 0053].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Masinaei et al and Vanderploeg et al by using a pH between 3.5 and 4.0; Low pH compositions are often used in various applications due to their ability to effectively remove stains and improve whiteness such as improved removal of residues from fabrics and associated improvement in whiteness.
Regarding claim 60, Masinaei et al disclose wherein the non-demineralized cortical bone graft comprises cortical bone fibers, cortical bone particles, cortical bone sheets, cortical bone cubes, cortical bone shafts, or a combination thereof [see 0013, 0031, 0036, 0071].
Regarding claims 61, 68, Masinaei et al disclose wherein the non-demineralized cortical bone graft comprises non-demineralized cortical bone fibers, and wherein the demineralized cortical bone graft comprises demineralized cortical bone fibers [see 0013, 0031, 0036, 0071].
Regarding claim 62, Masinaei et al disclose wherein the non-demineralized cortical bone fibers have an average shortest dimension of less than 200 µm [see 0076, 0112, 0127].
Regarding claim 64, Masinaei et al don’t disclose adding an effective amount of a buffer to the acid solution after the single incubation, wherein the pH of the resulting solution is adjusted to 2.5-7 within 90 seconds after the addition of the buffer.
Nonetheless, Vanderploeg et al disclose adding an effective amount of a buffer to the acid solution after the single incubation, wherein the pH of the resulting solution is adjusted to 2.5-7 within 90 seconds after the addition of the buffer [see 0052, 0055].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Masinaei et al and Vanderploeg et al by adding an effective amount of a buffer to the acid solution after the single incubation, wherein the pH of the resulting solution is adjusted to 2.5-7 within 90 seconds after the addition of the buffer; to improve the mixture.
Claim(s) 48, 63 are rejected under 35 U.S.C. 103 as being unpatentable over Masinaei et al (Pub. No.: US 2011/0045044) in view Vanderploeg et al (Pub. No.: US 2016/0184390) as applied to claims 44, 59 above and further in view of Shadduck et al (Pub. No.: US 2006/0085081)
Regarding claims 48, 63, Masinaei et al and Vanderploeg et al don’t disclose wherein the demineralized cortical bone fibers have an elastic modulus of less than 100 kPa.
Nonetheless, Shadduck et al disclose the elastomeric composition has an elastic modulus ranging between 5 MPa and 100 Kpa [see 0033, 0046].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Masinaei et al and Vanderploeg et al and Shadduck et al by using an elastomeric composition has an elastic modulus ranging between 5 MPa and 100 Kpa; for ensuring structural integrity and safety.
Claim(s) 49, 65 are rejected under 35 U.S.C. 103 as being unpatentable over Masinaei et al (Pub. No.: US 2011/0045044) in view Vanderploeg et al (Pub. No.: US 2016/0184390) as applied to claims 44, 59 above and further in view of Guze et al (Pub. No.: US 2012/0253470) and further in view of Bhattacharyya et al (Pub. No.: US 2015/0314043).
Regarding claims 49, 65, Masinaei et al and Vanderploeg et al don’t disclose releasing at least 75 wt % of calcium in the non-demineralized cortical bone fibers.
Nonetheless, Guze et al disclose releasing at least 75 wt % of calcium [see 0126] by disclosing within the range of 0-75 wt % [see 0126]
In addition, Bhattacharyya et al disclose removal of calcium from a control sample which is treated with acid without a vacuum applied while the lower trace illustrates removal of calcium when a low vacuum is applied. As shown, after 10 minutes the control sample treated with acid has the calcium content lowered to 15% to enhance processing of the sample, reduce time, and enhance efficiency (e.g., reduce transfer steps) and reduce excessive amounts of reagents to be added to the reaction [see 0114 and fig 9].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Masinaei et al and Vanderploeg et al and Guze et al and Bhattacharyya et al by releasing at least 75 wt % of calcium; to enhance processing of the sample, reduce time, and enhance efficiency (e.g., reduce transfer steps) and reduce excessive amounts of reagents to be added to the reaction [see 0114].
Claim(s) 50, 66 are rejected under 35 U.S.C. 103 as being unpatentable over Masinaei et al (Pub. No.: US 2011/0045044) in view Vanderploeg et al (Pub. No.: US 2016/0184390) as applied to claims 44, 59 above and further in view of Yayon et al (Pub. No.: US 2010/0274362)
Regarding claim 50, 66, Masinaei et al and Vanderploeg et al don’t disclose retaining at least 1 ng of a bone morphogenetic protein (BMP) per gram of the non-demineralized cortical bone fibers, based on the dry weight of the non-demineralized cortical bone fibers;
wherein the BMP is selected from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15 and a mixture thereof.
Nonetheless, Yayon et al disclose retaining at least 1 ng of a bone morphogenetic protein (BMP) per gram of the non-demineralized cortical bone fibers, based on the dry weight of the non-demineralized cortical bone fibers [see 0018-0019, 0184];
wherein the BMP is selected from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15 and a mixture thereof [see 0018-0019, 0184]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Masinaei et al and Vanderploeg et al and Yayon et al by retaining at least 1 ng of a bone morphogenetic protein (BMP) per gram and wherein the BMP is selected from the group consisting of BMP-2; to have a sufficient amount for the composition.
Claim(s) 51, 67 are rejected under 35 U.S.C. 103 as being unpatentable over Masinaei et al (Pub. No.: US 2011/0045044) in view of Vanderploeg et al (Pub. No.: US 2016/0184390) as applied to claims 44, 59 above and further in view of Kerr et al (Pub. No.: US 2013/0211541).
Regarding claims 51, 67, Masinaei et al and Vanderploeg et al don’t disclose wherein the non-demineralized cortical bone fibers are generated by a Computer Numerical Control (CNC) machine using a chip load of 0.004"-0.011".
Nonetheless, Kerr et al disclose wherein the non-demineralized cortical bone fibers are generated by a Computer Numerical Control (CNC) machine using a chip load of 0.004-0.011 [see 0094].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Masinaei et al and Vanderploeg et al and Kerr et al by having the non-demineralized cortical bone fibers are generated by a Computer Numerical Control (CNC) machine using a chip load of 0.004"-0.011"; to provide an appropriate dimension.
Claim(s) 53-55, 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Masinaei et al (Pub. No.: US 2011/0045044) in view of Shimp (Pub. No.: US 2005/0244239).
Regarding claims 53, 55, 57, Masinaei et al disclose a composition comprising cancellous bone particulate and demineralized cortical bone fibers [see 0007, 0013, 0031, 0067, 0069];
the demineralized cortical bone fibers having a residual calcium content of between 0.5-
6 wt % based on the dry weight of the demineralized cortical bone fibers [see 0036, 0049];
wherein the demineralized cortical bone fibers are osteoinductive [see 0063-0064, 0089];
wherein the demineralized cortical bone fibers are combined with and stored in glycerol [see 0011, 0014, 0018, 0028].
Masinaei et al don’t wherein the demineralized cortical bone fibers have a specific area 185-5,550 cm²/g.
Nonetheless, Shimp discloses wherein the demineralized cortical bone fibers have a specific area 185-5,550 cm²/g [see 0025] by disclosing "monolithic bone" is understood to have a surface area of at least 1 square centimeter [see 0025].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Masinaei et al and Shimp by using a specific area 185-5,550 cm²/g; to be provide an appropriate area.
Regarding claim 54, Masinaei et al disclose wherein the demineralized cortical bone fibers have an average shortest dimension of less than 200 µm [see 0076, 0112, 0127].
Regarding claim 58, Masinaei et al disclose a synthetic material [see 0031, 0034, 0036, 0050].
Claim(s) 56 is rejected under 35 U.S.C. 103 as being unpatentable over Masinaei et al (Pub. No.: US 2011/0045044) in view of in view of Shimp (Pub. No.: US 2005/0244239) as applied to claim 53 above and further in view of Shadduck et al (Pub. No.: US 2006/0085081)
Regarding claim 56, Masinaei et al and Shimp don’t disclose wherein the demineralized cortical bone fibers have an elastic modulus of less than 100 kPa.
Nonetheless, Shadduck et al disclose the elastomeric composition has an elastic modulus ranging between 5 MPa and 100 Kpa [see 0033, 0046].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Masinaei et al and Shimp and Shadduck et al by using an elastomeric composition has an elastic modulus ranging between 5 MPa and 100 Kpa; for ensuring structural integrity and safety.
Conclusion
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3798