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 .
Status of Claims
This office action is responsive to the amendment filed on 12/12/2025. As directed by the amendment: claims 1, 2, 5, 7 and 8 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-16 are presently pending in this application, and currently examined in the Office Action.
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 mold having a shape based on 3D measurements taken of a bone structure with a segmental defect which is not loading bearing (claim 5), and the mold having a shape based on 3D measurements taken of a bone structure of an individual and further comprising a groove, dome, bubble, hole and/or bubble-wrap shape (claim 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
*** It is to be noted that in the response dated 12/12/2025, Applicant argues that Figure 12 illustrates the above mentioned structures of claims 5 and 7. Examiner respectfully disagrees with Applicant’s assertion since Figure 12 illustrates a bone structure comprising an acetabulum, used to create a mold having that shape; however, any segmental defect (though none can actually be seen) in an acetabulum would not be considered “not loading bearing”, as set forth in claim 5, and the mold, which is acetabular shaped, does not show any additional groove, dome, bubble, hole and/or bubble-wrap shapes, as set forth in claim 7.
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 § 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 7 is 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. Claim 7 depends from claim 1, which sets forth the parameter of the mold having “a shape that is based upon three dimensional (3D) measurements taken from a bone structure of the individual”, and claim 7 further sets forth the parameter of “the mold further comprises a groove, dome, bubble, hole and/or bubble-wrap shape”; however this parameter if found to be confusing for a few reasons. Firstly, it is unclear what exactly, structurally/shape-wise, is meant by “bubble” and “bubble-wrap” shapes. Secondly, it is unclear, how the mold can be shaped based 3D measurements of a bone structure of a patient, and also, comprise any of the above mentioned shapes, specifically how can the mold have a shape based on bone structure of an individual/patient, but also have a shape which comprises a groove, dome, bubble, hole and/or bubble-wrap shape; and the originally filed disclosure does not aid in explaining and/or illustrating such a parameter. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Note
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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, 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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over McKay (US PG Pub. 2006/0247772) in view of Boyce et al. (US PG Pub. 2007/0233272), as previously disclosed, hereinafter Boyce.
Regarding claims 1-4, 10, 12 and 14-16, McKay discloses a method of making a bone implant for an individual comprising loading a bone composition into a mold, wherein the bone composition comprises demineralized bone/bone fiber and does not comprise a binder or a chemical cross-linker; apply pressure of about 1000 psi, at room temperature, to the loaded bone composition to fit the mold; and freeze drying the compressed bone composition to make the bone implant; wherein the bone implant has a wet compressive strength of less than 3MPa ([0012]; [0029], specifically line 5; [0036], Lines 1-5; [0043] & [0044], Lines 1-3 – it is to be noted that 200N/cm2 converts to 2MPa); but does not specifically disclose the mold has a shape that is based upon three dimensional (3-D) measurements taken from a bone structure of a human, and the mold being constructed with 3-D printing.
However, Boyce teaches a method of making a bone implant for an individual, in the same field of endeavor, where the mold used in forming the implant is shaped based on 3-D measurements taken from a bone structure of a human, and the mold being constructed with 3-D printing ([0120] & [0121]); resulting in a patient specific mold, and thereby patient specific implant.
In view of the teachings of Boyce, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the method of McKay to further including the mold being constructed by 3-D printing such that is has a shape based on 3-D measurements taken from a bone structure of a human patient, as taught by Boyce, in order to make a patient specific mold, thereby resulting in a patient specific implant with an optimal fit.
Regarding claims 5 and 6, McKay in view of Boyce disclose the method of claim 1, wherein Boyce teaches that it is known for the bone structure is selected from a group consisting of a femur trochanter, a skull flap, and mandible; and more specifically the bone structure comprising a segmental defect which is not load bearing, and the mold having a shape that is based on the 3-D measurements of the segmental defect in the bone structure, example illustrated in Figure 11 (Boyce: [0124]; [0128]; [0129] & [0136]).
Regarding claim 7, McKay in view of Boyce disclose the method of claim 1, wherein both McKay and Boyce teach that it is known for the mold to further comprise a groove/hole (McKay: [0011] & Boyce: [0137]).
Regarding claims 8 and 9, McKay in view of Boyce disclose the method of claim 1, wherein Boyce teaches that it is known for the bone implant (110/112) to be used/applied with a prosthesis (114) comprising a metal or a synthetic material, illustrated in Figure 5 (Boyce: [0129]).
Regarding claim 11, McKay in view of Boyce disclose the method according to claim 1, and though it is not specifically disclosed that the pressure is between about 200 psi and 950 psi, one could argue that “about 1000 psi”, as disclosed by McKay ([0036], Lines 1-5), is within the range of “about 950 psi”, as set forth in the claim. Furthermore, it is to be noted that this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate range of pressure, including between about 200 psi and 950 psi, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05). Moreover, it is also noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the pressure being in the range of between about 200 psi and 950 psi, as opposed to any other ranges; in fact, a broad range of pressures are disclosed in the originally filed specification.
Regarding claim 13, McKay in view of Boyce disclose the method according to claim 1, wherein McKay further teaches the compressed bone composition retains its integrity in liquid for at least 5-30 minutes (McKay: [0042]).
Response to Arguments
Applicant’s arguments with respect to independent claim 1 have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, Applicant has amended independent claim 1 to recite, in part, that “the bone implant has a wet compressive strength of less than 3MPa”. In response to Applicant’s amendment, Examiner now cites the prior art of McKay, in addition to the prior art of Boyce; rejecting independent claim 1, and those claims that depend from it, as being unpatentable over McKay in view of Boyce.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 02/11/2026