DETAILED ACTION
This office action is responsive to the amendment filed December 12, 2025. Claims 1, 25, and 26 were amended. Claims 1, 6, 8-11, 16-18, 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57, 59-62, 64, 66-69, and 71 are pending, though claims 23, 25-27, 31, 53, 57, 59-62, 64, 66-69 and 71 were previously withdrawn from consideration.
It is respectfully noted that the amendment does not properly note the withdrawal of claims 23, 25-27, 31, 53, 57, 59-62, 64, 66-69 and 71 in the claim status identifiers. Applicant is requested to note such in any subsequent reply to this office 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 .
Response to Arguments
The outstanding rejections under 35 USC 112(b) of claims 1, 6, 8-11, and 33 are maintained.
No specific arguments were made except to state that the amendment to claim 1 was intended to clarify additional features and render the claim definite. Examiner disagrees that the amendment resolves the outstanding issues. The amendments to the claim clarify the adhesive limitation, but do not address the “not bone screw” and “not bone plate” limitations.
The rejection will be maintained.
Applicant’s arguments with respect to the rejection of claim(s) 1, 6, 8-11, 16-18, and 33 under 35 USC 102(a)(1) in view of Posnick (US 2006/0287654 A1) have been considered but are moot because the new ground of rejection does not rely on this reference alone as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly presented rejections are necessitated by the amendments to the claims of December 12, 2025.
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 1, 6, 8-11, 16-18 and 33 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.
Claim 1 teaches the device 1) does not include a bone screw; and 2) does not include a bone plate. Examiner finds the metes and bounds of these limitations to be unclear, and improper in view of the disclosed invention. Regarding the “not bone screw” limitation, examiner finds unclear what makes a screw a bone screw, or not – examiner points to fig. 6A. S2 (described as a screw “to be threaded into the native bone and flap” is clearly a bone screw. It is unclear how claim 1 can stand in view of this teaching. Regarding the “not bone plate” limitation, examiner finds unclear what is and is not a bone plate – examiner points to the structure of at least fig. 1 and fig. 5A and takes the position that both of these are examples of bone plates. Examiner requires clarification as to how these structures are not bone plates and it is unclear how the limitation of claim 1 can stand in view of these teachings.
It is noted claim 1 does not teach what the device is – only capabilities that the device has, and structures that the claim is not. It is not considered possible for someone reading this claim to know whether a device they have built falls within the scope of the devices that applicant has invented, or not; and the claim is not considered instructive to one reading it in understanding what applicant’s invention is. Applicant has simply not invented all of the devices which fall within the scope of this claim. Clarification is required.
Depending on response to these rejections and any clarification provided, thereby, examiner places applicant on notice that those responses may necessitate objections to the drawings for failing to teach the claimed invention; objections to the specification for failing to provide antecedent basis for claimed terms; and additional rejections under 35 USC 112(a). Those objections and/or rejections will be made if it becomes clear that what is claimed is not sufficiently supported by the originally presented disclosure.
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, as best understood, Posnick teaches a device 15 at figs. 4A-C for 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 15 does not comprise a bone screw, bone plate, connecting suture, or connecting wire – in the same way that screws S2 of applicant’s fig. 6A are not considered ‘bone screws’; and the structure of applicant’s fig. 5 are not considered bone plates, Posnick’s structures 13 and 15 are also not considered bone screws or bone plates, respectively.
Once a first alternative is met, the other alternatives are not considered.
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].
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, 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 16-18, 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. The device 15 is formed with an elastic modulus (e.g. resilience) [0048], [0040], [0050], [0051], [0055] – thereby making the structure of fig. 4A-C considered to be functioning as a clamp (for clamping the flap).
Regarding claim 33, the device 15 includes a screw relief hole 16.
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BATES/Primary Examiner, Art Unit 3799