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 . This office action is in response to Applicant Arguments/Remarks Made in an Amendment received on August 5, 2026. Claims 1-17 are currently pending.
Response to Arguments
Applicant's arguments filed August 5, 2026 have been fully considered but they are not persuasive. Applicant’s amendment “wherein at least one fixing element comprising a shaft that extends between the two positioning pins, the shaft defining a shaft axis and comprising a distal end with at least one lateral hook extending from the distal end in a direction transverse to the shaft axis, the at least one lateral hook comprising a form-fitting surface facing an anterior direction.” seeks to introduce new matter (see the rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) below). Applicant’s arguments with respect to claims 1-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to recite that the fixing element comprises a shaft extending between the two positioning pins, the shaft defining a shaft axis and comprising a distal end having at least one lateral hook extending from the distal end transverse to the shaft axis, with the lateral hook extending from the distal end transverse to the shaft axis, with the lateral hook comprising a form fitting surface facing in an anterior direction. The originally filed disclosure describes fixing element 102, form-fitting portion 103, snap-in hook 105, and anteriorly exposed undercut 110, but does not reasonably convey to one of ordinary skill that the inventors possessed the presently claimed shaft, distal-end, and transverse lateral-hook arrangement at the time of filing. The figures do not clearly and unmistakably disclose all of these structural relations in combination. As to claim 2, “at least one lateral hook.” is not expressly disclosed. Claim 10 has been amended to require that the fixing portion “consisting of a single planar surface centered between the two receiving bores.” The originally filed disclosure describes fixing portion 203 as being arranged mediolaterally between receiving bores 201 and as forming undercut 211 for complementary engagement with undercut 110. The originally filed disclosure does not reasonably convey possession of a fixing portion limited to a single planar surface, particularly to the exclusion of other surfaces or structures required by the term “consisting of.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Haddock et al. (US Publication 2019/0150948), hereinafter “Haddock” in view of Zapari et al. (US 2022/0313336), hereinafter “Zapari”.
Regarding claim 1, Haddock discloses a surgical instrument for use in a knee joint replacement operation, the surgical instrument comprising a fastening device (300, capable of releasably fastening to a femoral trial implant mounted on a distal femur, the fastening device comprising two positioning pins (304, Figure 3) which are arranged spaced apart mediolaterally from each other and which, for the purpose of positioning the fastening device, are designed to be capable of being plugged in a posterior direction into two receiving bores, complementary to the positioning pins, of the trial implant, the fastening device further comprising at least one fixing element (306, Figures 6B and 6C) capable of fixing the fastening device in a form-fitting manner to the trial implant in an anterior direction.
Haddock fails to disclose wherein at least one fixing element comprising a shaft that extends between the two positioning pins, the shaft defining a shaft axis and comprising a distal end with at least one lateral hook extending from the distal end in a direction transverse to the shaft axis, the at least one lateral hook comprising a form-fitting surface facing an anterior direction.
Zapari, however, teaches a spring-biased transverse-hook connector [paragraph 0047]. Zapari teaches wherein at least one fixing element (104, Figure 5) comprising a shaft, the shaft defining a shaft axis and comprising a distal end with at least one lateral hook (110, Figure 5) extending from the distal end in a direction transverse to the shaft axis (i.e., the hook has a rearward surface that is in a direction transverse to the shaft), the at least one lateral hook comprising a form-fitting surface (132, Figure 5) facing an anterior direction.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the releasable fastening arrangement of Haddock to include the spring biased level and transverse hook as taught by Zapari such that a hook automatically seats in a complementary notch when the components are brought together and may be released by actuating the lever; such that in combination the shaft extends between the two positioning pins.
Regarding claim 2, the modified Haddock’s instrument discloses wherein the at least one lateral hook comprises at least one snap-in hook [paragraph 0047 describes a snap-in hook 110 in and release of the hook from the notch of Zapari].
Regarding claim 3, the modified Haddock’s instrument discloses wherein the at least one fixing element is capable of being adjustably movable, relative to the two positioning pins, between a fixing position and a release position (i.e. when 306 is moved into 130 to secure the trial component 100 and 300 [paragraph 0037] of Haddock).
Regarding claim 4, the modified Haddock’s instrument discloses wherein the fastening device comprises at least one spring element (316, Figure 3 of Haddock) capable of generating a spring force which biases the at least one fixing element toward the fixing position [paragraph 0048 of Haddock].
Regarding claim 5, the modified Haddock’s instrument discloses wherein the at least one spring element comprises a torsion or beam spring element (see Figure 3 of Haddock).
Regarding claim 6, the modified Haddock’s instrument discloses wherein the form-fitting portion (body of 306, Figure 3 of Haddock) produces a form fit between the fastening device and the trial implant [paragraph 0048 of Haddock and paragraph 0047 of Zapari].
Regarding claim 7, the modified Haddock’s instrument discloses wherein the two positioning pins are each elongate in an anteroposterior direction between a first and a second end (see the diagram below of Haddock), wherein a first end portion present at the respective first end is capable of being receivable in the posterior direction in one of the receiving bores of the trial implant so as to form a plug connection.
Regarding claim 8, the modified Haddock’s instrument discloses wherein the form-fitting surface creates an undercut (see the diagram below of Haddock) with respect to the anterior direction.
Regarding claim 9, the modified Haddock’s instrument discloses wherein the first ends are exposed posteriorly and the undercut is exposed anteriorly, such that the femoral trial implant can be positioned anteroposteriorly between the first ends and the undercut (see the diagram below of Haddock).
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Regarding claim 10, the modified Haddock’s instrument discloses a femoral trial implant (100, Figure 1 of Haddock) capable of being used in a knee joint replacement operation, the femoral trial implant comprising: a bone contact surface (108, Figure 5 of Haddock) capable of contacting a distal femur; two receiving bores (128, Figure 5 of Haddock) each capable of receiving a positioning pin of a surgical instrument; and a fixing portion (130, Figure 5 of Haddock) which is capable of forming -fit connection to a fixing element of the surgical instrument., the fixing portion consisting of a single planar surface centered between the two receiving bores (in as much as applicant describes the fixing portion ‘consisting of’ a single planar surface centered between two receiving bores, one of 306 is approximately centered between grooves 130).
Regarding claim 11, the modified Haddock’s instrument discloses a femoral trial implant according to claim 10, wherein the bone contact surface is arranged on a proximal rear face of a main body of the femoral trial implant and lies opposite a distal front face of the main body (136, Figure 5 of Haddock), wherein the main body has two condyle portions (108, Figure 5 of Haddock) which are spaced mediolaterally apart from each other and which each extend in an anteroposterior direction and transition at their anterior ends into a connection portion of the main body, wherein the fixing portion is arranged at a posterior end of the connection portion, mediolaterally between the two condyle portions (i.e., grooves 130 are located between condyle portions 108, see Figure 5 of Haddock).
Regarding claim 12, the modified Haddock’s instrument discloses wherein the fixing portion is arranged at a proximodistal distance from the two receiving bores (see Figure 5 of Haddock).
Regarding claim 13, the modified Haddock’s instrument discloses wherein the fixing portion creates an undercut (i.e. 130 creates an abutment surface for 306 of Haddock) with respect to a posterior direction.
Regarding claim 14, Haddock discloses wherein at least one of the two receiving bores is a blind hole (as best seen in Figures 5-6c, there’s no outlet for 304, within 128 of Haddock).
Regarding claim 15, the modified Haddock’s instrument discloses a surgical instrument system for use in a knee joint replacement operation, the surgical instrument system comprising: the surgical instrument according to claim 1; and at least one femoral trial implant (100, Figure 5 of Haddock) comprising: a bone contact surface (108, Figure 5 of Haddock) capable of contacting a distal femur; two receiving bores (128, Figure 5 of Haddock) each capable of receiving one of the positioning pins of the surgical instrument; and a fixing portion (130, Figure 5 of Haddock) capable of forming-fit connection to a fixing element of the surgical instrument [paragraph 0050 of Haddock], wherein the surgical instrument is releasably fastened to the at least one femoral trial implant, wherein the positioning pins and the receiving bores have complementary configurations [paragraph 0051 of Haddock], wherein the positioning pins are at least partially plugged into the receiving bores along the posterior direction (see Figure 6B of Haddock), wherein the fixing element and the fixing portion are tailored to each other to produce a form fit, and wherein the surgical instrument is fixed on the at least one femoral trial implant by the form fit [paragraph 0051 of Haddock].
Allowable Subject Matter
Claim 17 is allowed.
Claim 16 is 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
