Detailed Action
This is the first office action on the merits for US application number 18/442,230.
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 .
Election/Restrictions
Applicant’s election of species B) of Figs. 9-14 in the reply filed on September 29, 2025 is acknowledged, which indicated that claims 1 and 6-20 read on the elected species. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 8, the specification appears to lack proper antecedent basis for the elected species of Figs. 9-14 having “a fixing screw configured to make the adapter element integral with the prosthesis component”. That is, the specification appears to be silent as to the unlabeled portions of adapter 117b in elected Figs. 9-14, which is clearly shown to have a different structure than that of non-elected species A) of Figs. 1-8 which clearly discloses a fixing screw 122 that is not shown for elected species B) of Figs. 9-14. Thus, the specification fails to provide proper antecedent basis for “a fixing screw configured to make the adapter element integral with the prosthesis component” of claim 8 for the elected species of Figs. 9-14.
As to claim 19, the specification appears to lack proper antecedent basis for the elected species of Figs. 9-14 having “the angle is about 20 degrees”. That is, the specification appears to be silent as to the unlabeled portions of adapter 117b in elected Figs. 9-14, which is clearly shown to have a different structure than that of non-elected species A) of Figs. 1-8 which clearly discloses a fixing screw 122 that is not shown for elected species B) of Figs. 9-14. Thus, the specification fails to provide proper antecedent basis for “the angle is about 20 degrees” of claim 19 for the elected species of Figs. 9-14.
As to claim 20, the specification appears to lack proper antecedent basis for the elected species of Figs. 9-14 having “the fixing screw includes external threads configured to threadably attach to the prosthesis component”. That is, the specification appears to be silent as to the unlabeled portions of adapter 117b in elected Figs. 9-14, which is clearly shown to have a different structure than that of non-elected species A) of Figs. 1-8 which clearly discloses a fixing screw 122 that is not shown for elected species B) of Figs. 9-14. Thus, the specification fails to provide proper antecedent basis for “the fixing screw includes external threads configured to threadably attach to the prosthesis component” of claim 20 for the elected species of Figs. 9-14.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a fixing screw configured to make the adapter element integral with the prosthesis component” of claim 8 for the elected species of Figs. 9-14, the “kit for removing prosthetic components, comprising the device of claim 7 and a plurality of adapter elements configured for a plurality of prosthetic components.” of claim 12, and “the fixing screw includes external threads configured to threadably attach to the prosthesis component” of claim 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "208" and "209" have both been used to designate a first circular sector in Figs .10 and 11 and on page 12 line 22-23. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "208" and "209" have both been used to designate a second circular sector in Figs .10 and 11 and on page 12 line 22-23. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “208” has been used to designate both first circular sector and second circular sector in Figs .10 and 11 and on page 12 line 22-23. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “209” has been used to designate both first circular sector and second circular sector in Figs .10 and 11 and on page 12 line 22-23. That is, paragraph 12 lines 19-28 discloses that bottom 206 “comprises a first circular sector 208 having a substantially cylindrical longitudinal development and a second circular sector 209 having a curved track-shaped longitudinal development and projecting toward the adapter element 117B. Moreover, the distal end 204 provides a lateral surface 210 having a conformation substantially mirroring that of the bottom 206, with a second hole 212 thus generated at the terminal end 212E of the second circular sector 209.”. However, Figs. 10 and 11 show 208 as the sector that is a curved shape projecting toward 117B with hole 212 at the terminal end and 209 as the sector that is perhaps intended to be substantially cylindrical. Thus, Examiner suggests amending the specification to be consistent with the labeling of Figs. 10 and 11.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 line 1 should read “A device for removing a prosthesis component, the device comprising:”.
Appropriate correction is required.
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.
Claim(s) 6 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 6 is/are unclear with regards to “the first end being configured to move the cutting element on the curved-track, at least partially wrapping the prosthesis component” in lines 8-10 and what is claimed to “at least partially wrapping the prosthesis component”, i.e. the missing noun prior to ‘at least’. This is particularly unclear as none of the first end, second end, or curved-track are shown to partially wrap the prosthesis component, e.g. Figs. 12A and 12B show this to never be the situation. Examiner is interpreting this as referring to, and suggests amending as, “the first end being configured to move the cutting element on the curved-track
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6-9, 11, 12, 14-18, 20, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tulkis (US 2006/0200165).
As to claim 1, Tulkis discloses a device (10, Figs. 1-16) capable of removing a prosthesis component (72, Figs. 8 and 13-16, ¶33), the device comprising: an elongated body (12) having a proximal handle (16, 22, 80, Fig. 2, ¶41) and a distal end (Fig. 2, 20); a coupling portion (18, Figs. 1 and 8) at the distal end (Fig. 8) capable of coupling with the prosthesis component (Fig. 8, ¶39); and a cutting element (34, 36) comprising a pivot (36, 52, 50, 48, Fig. 3, ¶35) and a hook-shaped portion (34), the cutting element being capable of moving about the pivot (¶38) between a first position (Fig. 1, ¶38) in which the hook-shaped portion is retracted to allow the coupling portion to abut onto the prosthesis component (¶38), and a second position (Figs. 14-16) in which the hook-shaped portion is capable of at least partially wrapping the prosthesis component (Figs. 14-16), the hook-shaped portion comprising a sharp end (37, 39, Figs. 4 and 16) capable of cutting off a bone portion at a rear surface of the prosthesis component (Figs. 8 and 14-16, ¶39 and 44-47).
As to claim 6, Tulkis discloses that the elongated body comprises a sliding groove (26, 28, Figs. 1, 6A-6D, and 8) and a curved-track shape at the distal end (tubular shape of 12, Figs. 3 and 7, ¶34); and wherein the device further comprises: a pushing rod (right portion of 54 as shown in Fig. 5, Fig. 5) having: a first end (61) capable of sliding in the sliding groove (Figs. 1, 6A-6D, and 8, ¶s 37 and 38) and a second end (60) connected to the pivot of the cutting element (Fig. 8, ¶36 discloses that aperture 62of 60 engaging pivot portion 52) and capable of abutting onto the curved-track (Figs. 1, 6A-6D, and 8, ¶s 37 and 38), the first end being capable of moving the cutting element on the curved-track (Figs. 1, 6A-6D, and 8, ¶s 37 and 38).
As to claim 7, Tulkis discloses that the coupling portion comprises an adapter element (as defined, Fig. 8) removably mounted on the elongated body (Fig. 8, ¶40 discloses removable attachment to 12 by 18 being screwed onto 12), and wherein the hook-shaped portion is further capable of at least partially wrapping the adapter element (Figs. 1 and 8).
As to claim 8, Tulkis discloses that the adapter element comprises a fixing screw (78, Fig. 8, ¶s 39 and 40, where ¶39 discloses being rotatably received in prosthesis hole and ¶40 discloses 18 engaging 72 with cooperating threaded elements) capable of making the adapter element integral with the prosthesis component (Fig. 8, ¶39).
As to claim 9, Tulkis discloses at least one actuator element (56, 58) longitudinally sliding (Fig. 1, ¶38) and capable of reversibly moving the at least one cutting element between the first position and the second position (¶38).
As to claim 11, Tulkis discloses that the coupling portion comprises a coupling surface (right facing surfaces of 18 as shown in Fig. 1, Fig. 1) capable of coupling to a glenoid prosthesis baseplate (due to the shape, Fig. 1).
As to claim 12, Tulkis discloses a kit (¶40) capable of removing prosthetic components (¶40), comprising the device of claim 7 (as detailed above) and a plurality of adapter elements (18s, ¶40) capable of use with a plurality of prosthetic components (¶40).
As to claim 14, Tulkis discloses the handle includes a longitudinally grooved surface (Fig. 1).
As to claim 15, Tulkis discloses that the distal end of the elongated body includes a coupling hole coaxial with the distal end (Figs. 7 and 8, ¶40 discloses removable attachment to 12 by 18 being screwed onto 12).
As to claim 16, Tulkis discloses that the coupling portion comprises an adapter element (as defined, Fig. 8) having a first cylindrical projection (Fig. 8, ¶40 discloses removable attachment to 12 by 18 being screwed onto 12) capable of being inserted into the coupling hole (Fig. 8, ¶40 discloses removable attachment to 12 by 18 being screwed onto 12), and a second cylindrical projection (78, Fig. 8, ¶s 39 and 40, where ¶39 discloses being rotatably received in prosthesis hole and ¶40 discloses 18 engaging 72 with cooperating threaded elements) capable of coupling with the prosthesis component (Fig. 8, ¶s 39 and 40, where ¶39 discloses being rotatably received in prosthesis hole and ¶40 discloses 18 engaging 72 with cooperating threaded elements).
As to claim 17, Tulkis discloses that the elongated body is free to rotate around the first cylindrical projection when the first cylindrical projection is inserted into the coupling hole (in order to screw 18 onto 12 as disclosed in ¶40, ¶40, or to unscrew 18 from 12).
As to claim 18, Tulkis discloses that longitudinal axes of the first cylindrical projection and the second cylindrical projection define an angle therebetween (Fig. 8).
As to claim 20, Tulkis discloses that the fixing screw includes external threads (on 78, Fig. 8, ¶s 39 and 40, where ¶39 discloses being rotatably received in prosthesis hole and ¶40 discloses 18 engaging 72 with cooperating threaded elements) capable of threadably attaching to the prosthesis component (Fig. 8, ¶s 39 and 40, where ¶39 discloses being rotatably received in prosthesis hole and ¶40 discloses 18 engaging 72 with cooperating threaded elements).
As to claim 21, Tulkis discloses that the coupling portion is integral with the distal end of the elongated body (when screwed together as disclosed in ¶40, Fig. 8, ¶40).
Claim(s) 1, 9, 10, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US 2015/0196402).
As to claim 1, Kim discloses a device (Figs. 6 and 7) capable of removing a prosthesis component (10, Figs. 6 and 7, abstract, ¶27), the device comprising: an elongated body (332) having a proximal handle (336/366) and a distal end (334);a coupling portion (360) at the distal end (Figs. 6 and 7, ¶62) capable of coupling with the prosthesis component (Figs. 6 and 7, ¶s 62 and 37); and a cutting element (300, 112) comprising a pivot (112) and a hook-shaped portion (300), the cutting element being capable of moving about the pivot (Figs. 6 and 7) between a first position (Fig. 6) in which the hook-shaped portion is retracted to allow the coupling portion to abut onto the prosthesis component (Fig. 6), and a second position (Fig. 7) in which the hook-shaped portion is capable of at least partially wrapping the prosthesis component (Fig. 7), the hook-shaped portion comprising a sharp end (318, Figs. 6 and 7, ¶59) capable of cutting off a bone portion at a rear surface of the prosthesis component (Fig. 7, ¶s 59 and 68);
As to claim 9, Kim discloses at least one actuator element (381, 380, 346, 396) longitudinally sliding (Figs. 6 and 7, ¶s 66 and 68) and capable of reversibly moving the at least one cutting element between the first position and the second position (¶69).
As to claim 10, Kim discloses at least one spring element (328) associated with the actuator element (Figs. 6 and 7, ¶69), the spring element being capable of being compressed toward the distal end and to bring the device into the second position (Figs. 6 and 7, ¶69);
As to claim 13, Kim discloses that the at least one spring element comprises a helical spring (Figs. 6 and 7) arranged longitudinally between the proximal handle and the pivot of the cutting element (Figs. 6 and 7).
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 of this title, 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) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tulkis.
As to claim 19, Tulkis discloses the invention of claim 18 as well as that the coupling portion may be various shapes for positively engaging with or locking prosthetic cups of different shapes and sizes while maintaining alignment of the rotational axis of the elongate member and the polar axis of the prosthetic cup (¶40).
Tulkis is silent to the angle being about 20 degrees.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the angle of Tulkis to be about 20 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the angle of about 20 degrees would not operate differently than the shown structure of Tulkis and would function appropriately with the claimed values as Tulkis discloses that the adapter coupling portion, and thereby the angle between axes of its portions, may be various shapes for positively engaging with or locking prosthetic cups of different shapes and sizes while maintaining alignment of the rotational axis of the elongate member and the polar axis of the prosthetic cup (Tulkis ¶40). Further, Applicant places no criticality on the angle claimed, indicating the angle varies from adapter to adapter in an exemplifying and non-elected embodiment of Fig. 4 is equal to 20 degrees (page 10 lines 20-23).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (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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/AMY R SIPP/Primary Examiner, Art Unit 3775