DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Status of the Claims
The response and amendment filed 02/25/2026 is acknowledged.
Claims 1-17 are pending.
Applicant’s election without traverse of Group III, claims 10-17 in the reply filed on 09/16/2025 is acknowledged.
The species election requirement has been withdrawn.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/16/2025.
Claims 10-17 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Withdrawn
The rejection of claims 10-17 under 35 U.S.C. 103 as being unpatentable over Lally, US 20150314045 and Kronenthal, US 20190134259 has been withdrawn because of Applicant’s amendment. The combined teachings of Lally and Kronenthal do not expressly teach the step of mixing the dry magnesium mixture with blood or a bone marrow derived product.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz, US 20180326124 and Kronenthal, US 20190134259.
Diaz teaches methods for treating bone defect voids which is a space spanning two bone fragments, e.g., a void created upon removing a bone defect (Diaz, e.g., 0013).
Diaz teaches the method comprising supplying a dry magnesium containing mixture comprising magnesia, potassium phosphate, and a tricalcium phosphate (tertiary calcium phosphate as per Diaz, e.g., 0010 and 0021 and 0056), wherein the weight percent ratio of potassium phosphate to magnesia is between about 3:1 and 1:1 (Diaz, e.g., 0021 and formulations I-X). The method further comprises mixing the dry magnesium containing mixture with blood or bone marrow derived product to form a biomaterial slurry corresponding to the claimed activated bone fusion slurry (Diaz, e.g., 0033-0038, and formulations I-X). The slurry may be configured as a paste or putty or other forms (Diaz, e.g., 0036 and 0039). Diaz teaches the method and material turns to bone to provide improved bone structure in the bone where applied, i.e., in the bone void space which is filled (Diaz, e.g., 0080-0082). Thus, the method includes permitting bone growth into the material providing fusion of bone structures adjacent to the bone void which is filled.
Diaz teaches the biomaterial offers a number of benefits including: enhanced adhesive strength (Diaz, e.g., 0060), enhanced osteoproliferative properties (Diaz, e.g., 0064), enhanced bone formation (Diaz, e.g., 0067), enhanced effectiveness for active compound delivery, e.g., antibiotics (Diaz, e.g., 0074-0075), improved resorption, improved porosity, and improved cohesion relative to other calcium phosphate cements, and offers improved effectiveness as a scaffold for tissue growth (Diaz, e.g., 0066). The adhesive properties allow attachment to both sides of the bone and creation of a scaffold to allow cells to regenerate bone (Diaz, e.g., 0066
Diaz teaches practicing the method to fuse adjacent bone structures in a bone void, but does not expressly teach filling a bone void in craniomaxillofacial surgery.
Diaz does not expressly teach the method further comprising applying the biomaterial to a mold and allowing the biomaterial to set in the mold to form a rigid structure.
However, Kronenthal teaches these limitations.
Kronenthal teaches methods for repairing cranial fractures by applying bone repair composition (HPC, homogenous putty composition) between bone fragments (Kronenthal, e.g., 0065 and Fig. 2: 210) and applying the composition in the form of a plate or tape (Kronenthal, e.g., 0065 and Fig. 2: 220). Kronenthal, e.g., fig. 2, refers to a facial fracture, but the method may also be practiced to repair a cranial flap in the skull, whereby the bone repair composition is applied to secure the bone flap to the skull by filling (spanning) the void space (Kronenthal, e.g., 0066, 0207, and Fig. 3:310, and 0007, and claims), and further secured to the bone as a rigid structure (plate) spanning the bone gap (Kronenthal, e.g., 0066, 0208, and Fig. 3: 320 and 0007, and claims). Kronenthal teaches a second portion of the HPC may be formed into a plate and applied across the bone gap to stabilize restored alignment of the bone in lieu of a conventional metal bone plate (Kronenthal, e.g., 0206-0208).
Methods for forming the plate include: forming the bone repair composition into a plate by applying the composition to a mold and hardening outside the body (Kronenthal, e.g., 0194).
Kronenthal teaches practicing the method with a variety of bone repair compositions, e.g., compositions comprising a magnesia (MgO), potassium phosphate, and a tricalcium phosphate such as hydroxyapatite, aka, Ca10(PO4 )6(OH)2 which is a tertiary calcium phosphate according to claim 17 (Kronenthal, e.g., 0165 and Table 2:8).
Kronenthal does not expressly teach the method comprising supplying a dry magnesium containing mixture comprising magnesia, potassium phosphate, and a tertiary calcium phosphate, wherein the weight percent ratio of potassium phosphate to magnesia is between about 3:1 and 1:1, and mixing the dry magnesium containing mixture with blood or bone marrow derived product to form a slurry. However, Diaz teaches this limitation.
It would have been obvious before the effective filing date of the presently claimed invention to combine the teachings of Diaz and Kronenthal to arrive at a method for fusing bone in the cranium or face having the claimed steps with a reasonable expectation of success.
Starting from Diaz, the skilled artisan would have been motivated to modify Diaz’s methods for fusing bone, e.g., filling bone voids, by placing the biomaterial slurry or putty in a mold and allowing it to harden, e.g., into a plate so that the plate may be secured across the bone void to further stabilize the correct alignment of the fractured bone, e.g. in the face or cranium, as taught by Kronenthal with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because Diaz suggests the material may be used for repairing bone voids in other forms and because Diaz suggests the slurry, paste or putty is effective when used with fixation devices such as plates.
Starting from Kronenthal, the skilled artisan would have been motivated to modify Kronenthal’s method by supplying a dry magnesium containing mixture comprising magnesia, potassium phosphate, and a tertiary calcium phosphate, such as hydroxyapatite, wherein the weight percent ratio of potassium phosphate to magnesia is between about 3:1 and 1:1, and mixing the dry magnesium containing mixture with blood or bone marrow derived product to form a slurry to practice Kronenthal’s methods for repairing bone fractures in the face or cranial flap repair with a bone repair composition having a number of benefits including: enhanced adhesive strength, enhanced osteoproliferative properties, enhanced effectiveness for active compound delivery, e.g., antibiotics, and enhanced bone tissue growth in the same way reported by Diaz. The skilled artisan may have found additional motivation since Diaz teaches the material actually turns to bone to provide improved bone structure in the bone. The skilled artisan would have had a reasonable expectation of success because Kronenthal teaches the method may be practiced with magnesia/potassium phosphate compositions similar to those of Diaz.
Applicable to claim 11: Kronenthal teaches wherein the rigid structure is a plate (Kronenthal, e.g., 0194 and 0206-0208).
Applicable to claims 12-15: Diaz teaches the composition further comprising a sugar compound, e.g. sucrose (Diaz, e.g., formulations I-VI including sugar replacement sucralose or the sugar sucrose).
Applicable to claim 16: Diaz teaches the composition further comprising monosodium phosphate, e.g., to make the composition more biocompatible (Diaz, e.g., formulation IV, 0055).
Applicable to claim 17: Diaz teaches the composition further comprising Ca10(PO4)6(OH)2 (Diaz, e.g., 0059, formulations I-IV and VI-X and claim 14).
Accordingly, the subject matter of claims 10-17 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615