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 .
Response to Arguments
In response to applicant's argument that the claimed surgical device is intended to be a surgical guide system and not a fixation implant, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the design and configuration of Dallis allow it to be fully capable of being used as a cutting or a harvest guide, as the openings within the device provide for bone removal. Dallis further recites that its device is used in conjunction with surgical instruments to allow for rapid application of plate to bone (paras. 0044, 00104-00114).
The Applicant also contends that Dallis does not disclose a patient-specific anatomical reference for guide positioning. The examiner respectfully disagrees. Dallis discloses that its device is provided with contours, sizes, shapes, and orientations that are specific to the bones and fractures it is fixing (paras. 0042-0043, 0083, 00105). It is further well known in the art to modify a device’s dimensions and orientations in order to properly fit a particular patient’s anatomy. Further in regard to the patient-specific configuration, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that several the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, in regard to the structural benefits of the claimed device, the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Attorney statements are not considered evidence, and they must be supported by an appropriate affidavit or declaration. These include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.
Applicant’s remaining arguments with respect to claim(s) 1-12 have been considered, but are moot in view of the new grounds of rejection. The Dallis reference has been re-interpreted, as described below to address the claim amendments filed on 3/24/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 and 8-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dallis (WO 2015/112991 A1).
Dallis discloses the following regarding claim 1: a surgical device comprising (i) a patient-specific malleolus cap (please see the annotated Figure A, below, for an example) (paras. 00100-00105), (ii) a connecting bar having at least two ends (e.g., Figure A), and (iii) an osteotomy guide (e.g., Figure A); wherein the patient-specific malleolus cap is detachably or non-detachably connected to the osteotomy guide via the connecting bar (e.g., Figure A); and wherein the connecting bar contacts the malleolus cap and the osteotomy guide at opposite ends of the connecting bar (e.g., Figure A).
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Figure A.
Dallis discloses the following regarding claim 2: the surgical device of claim 1, wherein the osteotomy guide is a fibula cutting guide or a fibula harvest guide (paras. 0042-0046, 00100-00105). Please note that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the design and configuration of Dallis allow it to be fully capable of serving as a cutting or a harvest guide.
Dallis discloses the following regarding claim 3: the surgical device of claim 1, wherein the patient-specific malleolus cap comprises an inner cap surface (interior cap surfaces) and an outer cap surface (exterior cap surfaces), wherein the outer cap surface contacts one end of the connecting bar (e.g., Figure A).
Dallis discloses the following regarding claim 4: the surgical device of claim 1, wherein the patient-specific malleolus cap comprises an inner cap surface (interior cap surfaces) and an outer cap surface (exterior cap surfaces), wherein the inner cap surface comprises morphology modelled to fit the surface morphology of the patient's lateral malleolus (Figs. 10-12D; paras. 00100-00105).
Dallis discloses the following regarding claim 5: the surgical device of claim 1, wherein the patient-specific malleolus cap comprises a longitudinal axis (A) (e.g., annotated Figure B, below) substantially parallel to longitudinal axis of the connecting bar and longitudinal axis of the osteotomy guide (Figure B).
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Figure B.
Dallis discloses the following regarding claim 6: the surgical device of claim 5, wherein longitudinal axes of the malleolus cap, the connecting bar, and the osteotomy guide are offset relative to one another (e.g., Figure B).
Dallis discloses the following regarding claim 8: the surgical device of claim 1, wherein the connecting bar contacts the patient-specific malleolus cap and the osteotomy guide via connecting rods (bodies of the connecting bars) contacting the superior surface of the patient-specific malleolus cap and the osteotomy guide at an obtuse, right, or acute angle (Figure A; Figs. 10A-12D).
Dallis discloses the following regarding claim 9: the surgical device of claim 1, wherein the osteotomy guide is a patient-specific fibula cutting guide or a patient-specific fibula harvest guide (paras. 00100-00105). The design and configuration of Dallis allow it to be fully capable of serving as a cutting or a harvest guide.
Dallis discloses the following regarding claim 10: the surgical device of claim 1, wherein patient-specific malleolus cap, the osteotomy guide, and the connecting bar are formed from biocompatible, autoclavable resin, polymer, metal, or metal alloy (paras. 0055-0056, 0088).
Dallis discloses the following regarding claim 11: the surgical device of claim 1, wherein the device is made by a method selected from the group consisting of stereolithography, soft lithography, laser machining, laser cutting, micromachining, micromilling, curing, bonding, three-dimensional printing, molding, micromolding, and setting (paras. 0043-0046, 0052-0056). Please note that method limitations in article claims are considered to the extent that they further define the final structure of the claimed apparatus. As presently worded, the scope of the subject matter fails to structurally distinguish the claimed invention over the prior art.
Dallis discloses the following regarding claim 12: the surgical device of claim 1, wherein the device is configured for use in reconstruction surgery of head and neck bone defects, for use in jaw reconstruction surgery, or for use in jaw reconstruction surgery with dental implant placement (paras. 0043-0054, 0062-0063). The device of Dallis allows for a variety of patient-specific configurations that would allow it to be fully capable of being used on head, neck, and/or jaw bones.
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dallis.
Dallis discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the offset distances of the longitudinal axes of the malleolus cap, the connecting bar, and the osteotomy guide. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal dimensions of the surgical device, thus resulting in the longitudinal axes having optimal offset distances, needed to achieve the desired results and to properly fit a particular patient’s anatomy. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the dimensions of the surgical device and the resulting axes’ offset distances, would have been obvious at the time of applicant's invention in view of the teachings of Dallis. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. Such a modification would be made with a reasonable expectation of success.
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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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