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 .
Election/Restrictions
Applicant’s election without traverse of Group III, claims 15-21 in the reply filed on 2/20/2026 is acknowledged.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification fails to provide antecedent basis for “molten sucralose”. The specification refers to “sugars, caramel, pure sucralose, or melted sucralose” (para. 52), Examiner suggests amending the claim to recite ---melted sucralose--- to overcome this objection.
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 15, 18, 19, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al. (Pub. No.: US 2006/0024656).
Morris et al. (hereinafter, Morris) discloses a method for manufacturing a particulate bone material (abstract), comprising:
a) providing a bone material (para. 39, 40)
b) splitting (not disclosed) bone material into fragments (para. 40);
c) embedding the split bone material in a soluble containment matrix (para. 44);
d) drying the soluble containment matrix until a solidified containment matrix is obtained (para. 44, 51);
e) machining the solidified containment matrix of step d) by means of a cutting tool to obtain particulate bone material plus containment matrix (para. 45);
and f) removing the particulate bone material from the containment matrix (para. 46).
As provided in italicized text above, Morris does not specifically disclose splitting bone material, rather, Morris starts with pre-split material (para. 40). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have split the bone material instead of using pre-split material as an obvious expedient to yield small pieces per the Morris method.
For claim 18, Morris discloses the containment matrix is sugar and water (para. 51), however does not specify the containment matrix is [molten] sucralose. Use of melted sucralose is considered an obvious equivalent to the sugar and water mixture of Morris. One of ordinary skill in the art would have recognized the suitability and substitutability of melted sucralose (a material derived from sugar and which dissolves and melts) for melted sugar in the Morris process and would have substituted melted sucralose for sugar using known methods and yielding predictable results.
For claim 19, Morris discloses the method of Claim 15, wherein the particulate bone material is removed from the containment matrix with water (para. 44, 46, 51) at a temperature between 20°C and 30°C (not disclosed). However, it would have been obvious to have provided water between 20-30°C as an obvious expedient temperature known to dissolve sugar. This selection would have occurred using known methods and would have yielded predictable results.
For claim 21, Morris discloses the method of Claim 15, wherein the particulate bone material obtained has an form factor (FF) between 0.5 and 1 (para. 72).
Claims 16-17, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al. (Pub. No.: US 2006/0024656) in view of Clokie (U.S. Pat. No.: 6,287,312).
Morris is explained supra, however, Morris lacks a turning with the features specified in claim 16, a steel turning tool at 12% Co, or particulate bone material with a 90-120micron size. Clokie teaches a bone mill of 420 stainless steel (12%Co) (col. 3 lines 1-15), which yields particles from 50-500 microns (col. 3 lines 1-15). Selection of cutting tool feed, cutting speed, rake angle, clearance angle, main steering angle, and cutting depth would have been an obvious expedient to result in the milled bone of the same micron size range as Applicant’s claim 16. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the particulate bone method of Morris with the turning and particle size of Clokie as an obvious expedient to yield a particulate bone material suitable for use in orthopedic implants. This modification would have occurred using known methods and would have yielded predictable results.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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