DETAILED ACTION
This office action is responsive to the amendment and Request for Continued Examination filed July 13, 2026. By that amendment, claims 1 and 11 were amended; and claim 18 was canceled. Claims 1, 6, 8-11, 16, 17, 23, 25-27, 31, 33, 53, 57, 59-62, 64, 66-69, and 71 are pending, though claims 23, 25-27, 31, 53, 57, 59-62, 64, 66-69, and 71 were previously withdrawn from consideration.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 13, 2026, has been entered.
Response to Arguments
The outstanding rejection under 35 USC 112(b) related to claim 1 was overcome by amendment to the claim. The rejection is withdrawn.
Applicant's arguments filed July 13, 2026, regarding the rejection under 35 USC 103 in view of Posnick (US 2006/0287654 A1) and Hess et al. (US 2019/0300428 A1) have been fully considered but they are not persuasive, even in view of the amendments.
It is argued that neither Hess nor Posnick teaches or discloses a device having an adhesive composition for positioning or fixating a flap in or on the bone with a clamp comprising supportive structure including a compressive material, the adhesive being a particular composition. It is argued that the combination fails to teach all of the claimed features, “especially the clamp limitation, the adhesive composition… with an adhesive strength greater than 10kPa.”
Examiner agrees that neither reference teaches all of the claimed limitations, but notes the rejection relies upon a combination of the two references. Examiner takes the position that Posnick’s structure is a clamp which reads on what is claimed, and continues to be of the position that substituting Hess’ adhesive for Posnick’s was an obvious substitution. Examiner will identify in the prior art all features now required by the amended claims in the following rejection.
Examiner disagrees that Posnick does not teach a device capable of fixating a bone flap on a bone. The bone flap is not positively required, and only the ability to do so is required by the device claim. Portion 100 in fig. 1 of Posnick is analogous to the bone flap, and fixation of 100 to bone 101 demonstrates ability of Posnick to retain a bone flap to a bone.
The rejection of record is maintained, below, modified only to correlate to the claim amendments.
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, 6, 8-11, 16-18, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Posnick (US 2006/0287654 A1) in view of Hess et al. (US 2019/0300428 A1).
Regarding claim 1, Posnick teaches a device 15 at figs. 4A-C capable of positioning a flap (bone part on the right in fig. 4B) in a bone 14, wherein (i) the device 15 holds the flap in proximity to the bone 14 to allow for adhering the flap to the bone with an adhesive composition 19 [0045] and (ii) the device comprises a clamp (15 considered to be in the form of a clamp, capable of retaining a bone flap between flanges 15a/b) comprising a supportive structure (the entire structure of 15 is considered “supportive”; formed of metal or metal alloy [0035], this material is known to be supportive) including a compressive material (understood as is most reasonably broad to be a material capable of being compressed; metals and metal alloys [0035] are known to be compressive materials; note teachings of forming the device with a desired flexibility [0040], [0048]).
Posnick fails to teach the claimed adhesive, and essentially gives no particulars to the adhesive 19 which he discloses using.
Hess teaches the identical claimed adhesive at Formula IV at [0035] including tetracalcium phosphate [0035]. Hess discloses the adhesive having adhesive strength greater than 10kPa [0048].
It would have been obvious to one with ordinary skill in the art at the time of the invention to utilize the Hess adhesive in place of the adhesive composition 19 of Posnick. Doing so would have been substitution of one known adhesive for another known adhesive for the purpose of providing an adhesive having a more robust adhesive behavior toward bone and other materials (Hess, [0074]).
Regarding claim 6, the device protrudes from a surface of the bone 14 by about 1 mm to 10 mm: various heights are disclosed at [0055]. Some of the disclosed heights/thicknesses (which will result in a protrusion amount) are considered to fall within the range of “about 1mm to 10mm”.
Regarding claims 8-11, there is no reason the combination device cannot be used with a flap of native bone. It is noted that applicant’s disclosure has identified various metals as “synthetic biocompatible materials”. (example 20 in the enumerated embodiments). No special definition for the term “synthetic biomaterial” is provided, and examiner understands this to be identical in scope with the term “synthetic biocompatible material”.
The Posnick device 15 is disclosed being formed of synthetic biocompatible materials (i.e. a synthetic biomaterial), including titanium. [0012]
Regarding claims 16 and 17, the device 15 includes a mechanical feature usable across a kerf space dimension and native bone thickness (see fig. 4B; the back wall connecting flanges 15a/b). This same ‘back wall’ is considered a protrusion permitting fixation of the flap to 14.
Regarding claim 33, the device 15 includes a screw relief hole 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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