DETAILED ACTION
This is the first office action on the merits in this application. The claims of September 4, 2024, are under consideration. Claims 1-8 are pending.
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 § 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.
Claims 4 and 7 are 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.
Regarding claim 4, as presently written, it is unclear if this claim is a method step of the claimed method, or a ‘product by process’ limitation related to a structure of the claimed pellets. Examiner believes the claim to be intended as a positive step of forming the pellets. Examiner suggests amending the claim to recite “the method of claim 2, further comprising forming the plurality of bone pellets…” Clarification is required.
Regarding claim 7, “the bone particle pump” lacks antecedent basis in the claims. Correction is required.
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.
Claim(s) 1, 2, 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lawson (US 2010/0198140 A1) in view of Messerli (US 2007/0162132 A1).
Regarding claim 1, Lawson teaches a method for stabilizing a vertebral body as at figs. 2A-3, the method comprising:
creating one or more openings (steps 304-312) into a central region of the vertebral body 210 and dispose at least one cannula 202/204 in the one or more openings;
forming an internal cavity within the vertebral body through at least one of the one or more openings as seen in fig. 2A (step 312-314);
injecting bone particles into the internal cavity of the vertebral body (step 316);
applying pressure to the bone particles within the internal cavity of the vertebral body (step 318-326), thereby compressing them against a sidewall of the internal cavity (as by use of tamps; also, injection of liquid or paste filler is considered to do so); and
removing the at least one cannula and closing the one or more openings, thereby sealing the bone particles within the internal cavity of the vertebral body (while not mentioned, removing the cannula and closing the patient is considered inherent for the procedure to be successfully completed).
Lawson fails to teach the bone particles being injected through a bone particle catheter disposed within the at least one cannula. Rather, Lawson directly uses the cannula to transport and inject the pellets into the patient. Lawson does, however, teach that insertion of bone particles through a catheter is known [0007], [0011], [0029].
Messerli teaches a method of insertion of bodies 210 formed of bone particles [0051] through a cannula 602 with a catheter passing therethrough [0078], etc., and into a vertebral body (figs. 6A-8B, etc.).
While not relied upon for making this rejection, it is also noted that Messerli makes explicit teaching of removal of the equipment upon completion of the procedure. [0080], [0078], [0084], etc.
It would have been obvious to one with ordinary skill in the art at the time of the invention at the time of the invention to pass a catheter carrying the bone particles through the cannula of Lawson prior to the liquid injection step at 326. One would have done so to provide for a container which retains the implanted bone particles within the vertebral body of the patient (Messerli, [0078]).
Regarding claim 2, the bone particles are injected in the form of a plurality of bone pellets (see 214, 216, 218 in fig. 2A).
Regarding claim 6, applying pressure to the bone particles within the internal cavity of the vertebral body comprises inflating a kyphoplasty balloon inside the internal cavity, thereby crushing the plurality of bone pellets (within the balloon) against a wall of the internal cavity.
Regarding claim 7, the method (inherently) includes loading at least one barrel of a bone particle cartridge (a portion of cannula 102) with the bone particles (102 must have become loaded at some point in time to permit delivery as depicted at fig. 2A); loading the bone particle cartridge onto the bone particle pump – arrangement of 226 in fig. 2A is considered to function as a pump); and pushing a plunger (proximal end of 226 in fig. 2A) of the bone particle pump down the at least one barrel, thereby injecting the bone particles into the internal cavity of the vertebral body through the bone particle catheter disposed within the at least one cannula.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lawson in view of Messerli and Scarborough et al. (US 9,572,912 B2).
Regarding claim 5, combination suggests the limitations of claim 2, as above, but does not teach the plurality of bone pellets comprise a plurality of compressed bone strips pressed into the form of the plurality of bone pellets.
Scarborough teaches a method of forming bone pellets (abstract, etc.). The method involves a processing procedure as at fig. 2A in which bone strips 10 are converted to bone fibers; which fibers are disclosed as being placed into a mold to form pellets (col. 16, lines 1-20).
While not making this argument now, Examiner contemplates that bone fibers are essentially very thin bone strips.
It would have been obvious to one with ordinary skill in the art at the time of the invention to utilize bone pellets formed int eh Scarborough manner in place of the bone pellets disclosed by Lawson. One would have done so in order to provide for consistently sized and composed bone pellets which are sized and shaped for insertion to a graft site through a commonly sized and shaped cannula. (col. 16, lines 5-6)
Allowable Subject Matter
Claims 3, 4 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. No claim can be allowed which continues to have an outstanding rejection under 35 USC 112(b).
Regarding claim 3, it is noted that Masserli teaches formation of the bone bodies 210 of “cortical bone, cancellous bone or both” [0051] but this is not considered sufficient teaching to read upon the claimed “bicortical dowel of cancellous bone having cortical endcaps”.
Conclusion
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/DAVID W BATES/Primary Examiner, Art Unit 3799