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 .
Claim Interpretation
The interpretation of claim limitations under 35 U.S.C. 112(f), as set forth in the Office action mailed 11 September 2025, has been withdrawn in light of the amendment filed 04 December 2025.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 4 and 15-20 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 4, lines 2-3, “the sterile components of housing” lacks antecedent basis.
Claim 15, line 9, “the sterile housing” lacks consistent antecedent basis.
Claim 15, lines 10-11, “the docking station disposed on the referencing apparatus” lacks antecedent basis.
Claim 19, lines 6-7, “the docking station disposed on the referencing apparatus” lacks antecedent basis.
Claim 20, line 6, “surgical prosthetic insertion tool” lacks consistent antecedent basis.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 2, 7-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fry et al. (2018/0078266; cited by Applicant).
Regarding claim 1, Fry et al. disclose a referencing apparatus for application onto a patient (para. 0001 and refer to annotated Fig. 1, below), the referencing apparatus including:
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a support plate;
a first locating element 56a extending from the support plate;
a second locating element 56b extending from the support plate;
a third locating element 56c extending from the support plate; and
an electronic orientation monitor housing adapted to receive a surgical electronic orientation monitor (para. 0030) detachably engageable (para. 0027) to the support plate and a surgical implement (id. and para. 0094);
wherein the support plate is usable for taking measurements for calibrating the surgical electronic orientation monitor for subsequent use with the surgical implement (para. 0094);
a docking station (annotated Fig. 1, supra) adapted to receive the housing and thereby define a reference point external to and relative to the patient's anatomy (paras. 0001 and 0028);
wherein the first locating element 56a, the second locating element 56b and the third locating element 56c are arranged to be pushed down onto a patient to provide a reference orientation for the electronic orientation monitor with respect to a predetermined anatomical site (id. and para. 0035).
Regarding claim 2, using a sterile housing is disclosed (para. 0032).
Regarding claim 7, the first and second locating elements are first and second anterior superior iliac spine locating elements (para. 0035).
Regarding claim 8, the third locating element is a pubis locating element (para. 0035).
Regarding claim 9, the first and second locating elements include a patient connecting plate, e.g., the base or pads of the locating elements 56a and 56b (paras. 0035 and 0038).
Regarding claim 10, the patient connecting plate (id.) is arranged to fix to a patient above a desired location such as the anterior superior iliac spine (para. 0038).
Regarding claim 11, the electronic orientation monitor (para. 0030) is housed in the electronic orientation monitor housing (annotated Fig. 1, supra; para. 0032).
Regarding claim 12, the electronic orientation monitor housing (annotated Fig. 1, supra) is arranged to engage the support plate (paras 0028 and 0032) to provide the reference orientation for the electronic orientation monitor (para. 0094).
Regarding claim 13, the electronic orientation monitor (within the housing) is dockable with the docking station in either a first docking configuration (e.g. with the docking station on the “top” side shown in annotated Fig. 1) or a second docking configuration (e.g., the opposite side or “bottom” side as shown in annotated Fig. 1).
Regarding claim 14, the first docking configuration defines a first orientation (on one side of the support plate; i.e., the “top” as shown annotated Fig. 1) of the electronic orientation monitor relative to the referencing apparatus; and
wherein the second docking configuration defines a second orientation (on the opposite side of the support plate; i.e., the “bottom” as shown in annotated Fig. 1) of the electronic orientation monitor relative to the referencing apparatus.
Regarding claim 15, a method of using the referencing apparatus of claim 1 to calibrate the electronic orientation monitor includes the steps of:
positioning a patient connector plate, e.g., the base or pads of the locating elements over the left anterior superior iliac spine (paras. 0035 and 0038);
positioning a patient connector plate (id.) over the right anterior superior iliac spine (id.);
connecting the first and second locating elements to respective patient connector plates (the base or pads are connected to the locating elements 56a, 56b and 56c (annotated Fig. 1, supra, and para. 0035);
positioning the third locating element against the pubis (paras. 0035 and 0038);
placing the electronic orientation monitor (para. 0030) into a sterilised electronic orientation monitor housing configured for receiving a non-sterile electronic orientation monitor whilst preventing contamination with the sterile housing (para. 0032);
engaging the housing comprising the monitor housed therein (para. 0030 and 0032) to the docking station disposed on the referencing apparatus (annotated Fig. 1, supra) to assume a reference orientation external to and relative to the patient (para. 0001); and
calibrating the electronic orientation monitor (paras. 0091 and 0094).
Regarding claim 16, the referencing apparatus is disposed anterior to the patient during the steps of positioning a patient connector plate and during calibration of the electronic orientation monitor (annotated Fig. 1, supra, and para. 0038, describing reference points visible to the surgeon including the anterior superior iliac spine and pubic crest, thus requiring the reference apparatus to be disposed anterior to the patient).
Regarding claim 17, an anterior approach is used for surgical access to the patent's acetabulum (id. and paras. 0069 and 0085).
Regarding claim 18, the patient lies in a face up position during said steps (annotated Fig. 1, supra, and para. 0038, describing reference points visible to the surgeon including the anterior superior iliac spine and pubic crest, thus requiring the patient to lie in a face up position for these reference points to be accessible and visible to the surgeon).
Regarding claim 20, the method further comprises the steps of:
disengaging the housing and calibrated electronic orientation monitor from the docking station (paras. 0032, 0091, 0094);
engaging the housing and calibrated electronic orientation monitor to the surgical implement to provide a surgical prosthetic insertion implement referenced to the patient's anatomy (para. 0094);
orienting the surgical implement with the patient's anatomy (para. 0071, 0074 and 0075); and
inserting a prosthetic to the patient oriented to the patient's anatomy (id.).
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 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.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fry et al. (2018/0078266; cited by Applicant) in view of Rolf (2014/0151247).
Regarding claim 6, Fry et al. disclose the claimed invention except for the housing explicitly being a clamshell housing.
Rolf teaches that electronic components for surgical devices can be housed in a clamshell housing to facilitate closing off the housing and maintaining a sterile state (e.g., paras. 0002-0004).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the housing of Fry et al. as a clamshell housing, in view of Rolf, to facilitate closing off the housing and maintaining a sterile state.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Fry et al. (2018/0078266; cited by Applicant) in view of Lye (2015/0150692; previously cited by Examiner).
Regarding claim 19, Fry et al. disclose a method of using a referencing apparatus (annotated Fig. 1, supra) as claimed in Claim 1, to calibrate the electronic orientation monitor (para. 0030), the method including the steps of:
engaging the plurality of locating elements 56a, 56b, 56c against a plurality of anatomical sites including the iliac spine and pubic crest (paras. 0035 and 0038) so as to cause a docking station (annotated Fig. 1, supra) disposed on the referencing apparatus to assume a reference orientation relative to the plurality of predefined anatomical sites (paras. 0001, 0012, 0027 and 0028);
placing the electronic orientation monitor into a sterilised electronic orientation monitor housing configured for receiving a non-sterile electronic orientation monitor whilst preventing contamination with the sterilised housing (para. 0032) and docking the housing with the docking station so as to orient the electronic orientation monitor in a reference orientation (paras. 0027, 0028 and 0032); and
calibrating the electronic orientation monitor (paras. 0091 and 0094). It is further noted that Fry et al. disclose that the ends of the locating elements 56a, 56b, 56c (i.e., the ends of the aligners; para. 0131) can include a contoured terminal surface to conform with an anatomical reference point (para. 0035).
Thus, Fry et al. disclose the claimed method except for explicitly positioning surgical drapes onto a patient, and engaging the plurality of locating elements 56a, 56b, 56c against the surgical drapes such that the surgical drapes are disposed intermediate the plurality of locating elements and a respective plurality of predefined anatomical sites on the patient.
Lye also discloses a method of using a referencing apparatus 1 (Fig. 1; para. 0062; claims 41 and 42) including positioning surgical drapes onto a patient (id.), and engaging a plurality of locating elements 2, 3, 4 against the surgical drapes such that the surgical drapes are disposed intermediate the plurality of locating elements and a respective plurality of predefined anatomical sites on the patient (para. 0024). A cavity (i.e., the circular opening at the end of the locating elements 2, 3, 4; Fig. 1) defined by each locating elements is sized to receive a projection of the surgical drapes caused by the respective anatomical site (para. 0024). This configuration allows accurate placement of the reference apparatus while still being able to maintain a sterile operating environment by using surgical drapes between the referencing apparatus and the patient.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to include steps in the method of Fry et al. including positioning surgical drapes onto a patient, and engaging the plurality of locating elements 56a, 56b, 56c against the surgical drapes such that the surgical drapes are disposed intermediate the plurality of locating elements and a respective plurality of predefined anatomical sites on the patient, in view of Lye, to allow accurate placement of the reference apparatus while still being able to maintain a sterile operating environment by using a surgical drapes between the referencing apparatus and the patient.
Allowable Subject Matter
Claims 3 and 5 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.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
Claims 3-5 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose or suggest the claimed combination of limitations directed to the lock recited in parent claim 3. In particular, none of the cited references teach or suggest a lock comprising: an enclosed frame adapted for engagement with the docking station, wherein the frame is pivotally attached to the body of the housing; and a central aperture shaped to receive the docking station within it, thereby to fix the orientation monitor to the reference apparatus to orient the electric orientation monitor with respect to the patient, as required by claim 3. It is noted that the load funnel as claimed is known in the prior art (see, e.g., references mentioned in the Conclusion and cited on attached PTO-892).
Response to Arguments
Applicant’s arguments filed 04 December 2025 with respect to the amended claims 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892. It is noted that the following cited references disclose various examples of the load funnel described in the first part of claim 3: Eskridge (20060217729); Fry (20150272696); Friedrich (DE 102010053814 B4); Meade (WO 2007089603 A2).
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 C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773