DETAILED ACTION
This office action is responsive to the amendment filed December 16, 2025. By that amendment, claims 1, 26 and 27 were amended. Claims 1-27 are pending.
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
As agreed in the phone interview of December 15, 2025, the statutory double patenting rejection of claim 15 is hereby withdrawn, and replaced with a non-statutory double patenting rejection.
Applicant’s arguments with respect to the rejection of claim(s) 1-3, 6-12, 16-25 and 27 under 35 USC 102(a)(1) in view of Bittenson (US 2013/0261681 A1) and the rejection of claims 4, 5, and 26 under 35 USC 103 in view of Bittenson, Mandanis (US 5,485,887) and Grunig (US 7,637,327) and claims 13 and 14 under 35 USC 103 in view of Bittenson and Dory (US 4,727,875) 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. The newly presented rejection was necessitated by the amendments to the claims of December 16, 2025.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,918,268. Although the claims at issue are not identical, they are not patentably distinct from each other because the main distinction between the two claims is that the ‘268 patent includes a plurality of windings, whereas the instant claim requires only “a” winding. Duplication of parts is considered to be an obvious modification.
US 11,918,268 – claim 1
Instant – claim 15 (presented in independent form)
An orthopaedic impactor, comprising:
a strike assembly;
a connector arranged to impart a force to an object; and
a plurality of windings arranged to receive a current and thereby generate a magnetic field;
wherein the plurality of windings, the strike assembly, and the connector are arranged so that, in use, a magnetic field generated by the plurality of windings causes the strike assembly to move so as to impact the connector;
wherein the connector is arranged to move between a first position and a second position such that:
in the first position, when the strike assembly impacts the connector, the connector imparts a force to the object in a first direction; and
in the second position, when the strike assembly impacts the connector, the connector imparts a force to the object in a second direction;
wherein the first direction and the second direction are different;
wherein:
the plurality of windings includes one or more proximal impact windings arranged to provide a force in the first direction;
the plurality of windings includes one or more distal impact windings arranged to provide a force in the second direction; and
at least one of:
the one or more proximal impact windings are arranged to provide a greater impact energy and/or impact force to the object than the one or more distal impact windings;
the one or more proximal impact windings have a greater volume, length, and/or surface area than the one or more distal impact windings; and
the impactor comprises a greater number of proximal impact windings than distal impact windings.
An orthopaedic impactor, comprising:
a strike assembly;
a connector arranged to impart a force to an object; and
a winding arranged to receive a current and thereby generate a magnetic field;
wherein the winding, the strike assembly, and the connector are arranged so that, in use, a magnetic field generated by the winding causes the strike assembly to move so as to impact the connector; and
wherein the connector is arranged to be secured within the impactor while being arranged to move, relative to the strike assembly, between a first position and a second position such that:
in the first position, when the strike assembly impacts the connector, the connector imparts a force to the object in a first direction; and
in the second position, when the strike assembly impacts the connector, the connector imparts a force to the object in a second direction;
wherein the first direction and the second direction are different.
one or more proximal impact windings arranged to provide a force in the first direction; and
one or more distal impact windings arranged to provide a force in the second direction.
at least one of:
arranged to provide a greater impact energy and/or impact force to the object than the distal impact windings; and
have a greater volume, length, and/or surface area than the distal impact windings; and
the impactor comprises a greater number of proximal impact windings than distal impact windings.
Claim Objections
Claim 27 is objected to because of the following informalities: at lines 16-17, the claim includes semicolons which should more appropriately be commas. Appropriate correction is requested.
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) 1-12 and 16-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Appel et al. (US 5,108,400) in view of Bittenson (US 2013/0261681 A1) and Grunig (US 7,637,327 B2).
Regarding claim 1, Appel teaches an orthopaedic impactor as seen at fig. 1, comprising:
a strike assembly 10/12;
a connector 5 arranged to impart a force to an inferred object 16; and
a power source (pneumatic coupling and associated structures);
wherein the power source (pneumatic arrangement), the strike assembly 10/12, and the connector 5 are arranged so that, in use, power generated by the power source (pneumatic) causes the strike assembly 10/12 to move so as to impact the connector 5; and
wherein the connector 5 is arranged to be secured within the impactor of fig. 1 while being arranged to move, relative to the strike assembly 10/12, between a first position and a second position (compare figs. 2-5) such that:
in the first position of fig. 2, when the strike assembly 10/12 impacts the connector 5 as in fig. 3, the connector 5 imparts a force to the (inferred) object 16 in a first direction (into the bone; col. 5, line 35 – col. 6, line 3); and
in the second position of fig. 4, when the strike assembly 10/12 impacts the connector 5 as in fig. 5, the connector 5 imparts a force to the object in a second direction (pulling out direction; col. 6, lines 4 – 27);
wherein the first direction and the second direction are different (forward and reverse).
Appel fails to teach a winding arranged to receive a current and thereby generate a magnetic field; or that the magnetic field generated by the winding causes the strike assembly to move so as to impact the connector. Rather, Appel teaches a functionally equivalent pneumatic mechanism for causing the strike assembly to impact the connector.
Grunig teaches a surgical percussive tool for creating impact to a tool bit holder. (abstract). Grunig further teaches that pneumatic and electromagnetic drive are functionally equivalent mechanisms for powering the impacts. (col. 3, lines 7-19)
Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to select an electromagnetic drive means to drive the impacts of the Appel device based on the Grunig teaching.
The combination of Appel and Grunig, while providing for the functional equivalence of the two drive mechanisms, continues to fail to provide for the particular claimed structure of a winding to create a magnetic field to cause impacts. Such is considered essentially inherent in an electromagnetic mechanism, but it will be shown that such structures are known in the art:
Bittenson teaches an orthopedic impactor including a winding 138 which functions to create a magnetic field to drive a strike assembly 136 to impact a connector 124.
It would have been obvious to one with ordinary skill in the art at the time of the invention to have used the Bittenson arrangement including control and sensing means to drive the Appel device as modified in view of the Grunig teaching. One would have done so in order to achieve the electromagnetically driven impact tool that Grunig suggested as a functionally equivalent to a pneumatic impactor.
Regarding claim 2, the strike assembly 10/12 comprises a striker 12 arranged to impact the connector 5 and the connector 5 is arranged to be impacted by the striker 12.
Regarding claim 3, the connector 5 at least partially surrounds the striker 12 of the strike assembly 10/12 and is arranged to receive a force from the striker 12 and to impart a force to the inferred object 16.
Regarding claim 4, the connector 5 is arranged to move between the first position of fig. 2 and the second position of fig. 4 wherein: in the first position of fig. 2, the striker 12 is arranged to impact a first surface 20 of the connector 5 (as in fig. 3) so as to impart a force to the inferred object 16 in the first direction; and
in the second position of fig. 4, the striker 12 is arranged to impact a second surface 8 of the connector so as to impart a force to the object in the second direction;
wherein the first direction and the second direction are opposite directions; and
wherein the force in the first direction is an implanting force and the force in the second direction is a removing force.
Regarding claim 5, the connector 5 is arranged to receive a first force from a first, proximal striker 14 of the strike assembly 10/12 and the connector 5 is arranged to receive a second force from a second, distal striker 13 of the strike assembly 10/12.
Regarding claim 6, a body 10 is present as a portion of the strike assembly 10/12. The combination fails to teach any particular material of the body 10, though it is clear that the material of the strike assembly of the combination must be ferromagnetic based on the functionality of the Bittenson device. It would have been obvious to one with ordinary skill in the art at the time of the invention to select one of the claimed materials: It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In this case, one would have chosen one of the claimed materials as a matter of selecting a material of sufficient strength and a desirable material property for use as an impaction tool.
Regarding claim 7, in the combination, the provision of a current, and the generation of the magnetic field, is arranged to cause the strike assembly 10/12 to move relative to 5 to provide an implanting force or a removal force.
Regarding claim 8, in the combination, the removal of a current, and the cessation of the generation of the magnetic field, is arranged to cause the strike assembly to move to provide an implanting force or a removal force.
Regarding claim 9, the winding 138 of the combination is arranged to radially or axially surround a ferromagnetic body of the strike assembly 10/12.
Regarding claim 10, Appel utilizes pneumatic pressure as a functional biasing mechanism arranged to bias the strike assembly towards a first resting position. Bittenson teaches use of springs 140 to accomplish the same. It would have been obvious to include the spring 140 of Bittenson into the combination in order to achieve additional functionality equivalent to the pneumatic assembly of the combination.
Regarding claim 11, the biasing mechanism comprises a spring 140 arranged to compress as the strike assembly is moved from the first position to the second position (see Bittenson fig. 2B)
Regarding claim 12, the combination includes a plurality of windings 138 arranged to provide forces of different magnitudes [0046].
Regarding claim 16, the combination includes a power source 126 (e.g. battery) for supplying the current to the winding 138.
Regarding claims 17 and 18, the combination further includes an input [0041] for altering a parameter of the force (esp. magnitude and frequency). Additional details of the input are found at [0060] and fig. 6E.
Regarding claim 19, the combination includes a sensor arranged to measure an impact energy [0045].
Regarding claim 20, the impactor is arranged to determine a position of the strike assembly (through use of a hall sensor [0055]).
Regarding claims 21 and 22, the combination includes control electronics [0041, 0060] arranged to alter the supply of current to the winding 138, to interact with an input 128. [0041] Energy delivered can be determined [0045] such that an impact force can be modified [0055].
Regarding claim 23, the combination includes a spacer 124 arranged to limit the travel of the strike assembly and/or the connector.
Regarding claim 24, the combination impactor is an orthopaedic impactor (abstract).
Regarding claim 25, the combination suggests a method of operating an impactor of claim 1 including the claimed steps, as indicated above in rejecting claim 1.
Regarding claim 26, Appel teaches an orthopaedic impactor, comprising:
a strike assembly 10/12 comprising a striker 12;
a power source (pneumatics); and
a connector 5, wherein the connector 5 is arranged to at least partially surround the striker 12 of the strike assembly 10/12 and is arranged to receive a force from the striker 12 and to impart a force to an inferred object 16;
wherein the connector 5 is arranged to be secured within the impactor of fig. 1 while being arranged to move, relative to the strike assembly, between a first position and a second position (compare figs. 2-5) such that:
in the first position as at fig. 3, the striker 12 impacts a first surface 20 of the connector 5 and the connector imparts a first force to the object 16 in a first direction; and
in the second position as at fig. 4, the striker 12 impacts a second surface 8 of the connector 5 such that the connector imparts a second force to the object 16 in a second direction;
wherein the first direction and the second direction are different (pushing/pulling).
Appel fails to teach a winding arranged to receive a current and thereby generate a magnetic field; or that the magnetic field generated by the winding causes the strike assembly to move so as to impact the connector. Rather, Appel teaches a functionally equivalent pneumatic mechanism for causing the strike assembly to impact the connector.
Grunig teaches a surgical percussive tool for creating impact to a tool bit holder. (abstract). Grunig further teaches that pneumatic and electromagnetic drive are functionally equivalent mechanisms for powering the impacts. (col. 3, lines 7-19)
Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to select an electromagnetic drive means to drive the impacts of the Appel device based on the Grunig teaching.
The combination of Appel and Grunig, while providing for the functional equivalence of the two drive mechanisms, continues to fail to provide for the particular claimed structure of a winding to create a magnetic field to cause impacts. Such is considered essentially inherent in an electromagnetic mechanism, but it will be shown that such structures are known in the art:
Bittenson teaches an orthopedic impactor including a winding 138 which functions to create a magnetic field to drive a strike assembly 136 to impact a connector 124.
It would have been obvious to one with ordinary skill in the art at the time of the invention to have used the Bittenson arrangement including control and sensing means to drive the Appel device as modified in view of the Grunig teaching. One would have done so in order to achieve the electromagnetically driven impact tool that Grunig suggested as a functionally equivalent to a pneumatic impactor.
Regarding claim 27, Appel teaches an orthopaedic impactor as at fig. 1, comprising:
a strike assembly 10/12;
a connector 5 arranged to impart a force to an object 16; and
a power source (pneumatics);
wherein the power source, the strike assembly 10/12, and the connector 5 are arranged so that, in use, power from the power source causes the strike assembly 10/12 to move relative to 5 so as to impact the connector 5; and
wherein the connector 5 is arranged to move, relative to the strike assembly 10/12, between a first position as at figs. 2-5 and a second position such that:
in the first position as at fig. 3, when the strike assembly 10/12 impacts the connector 5, the connector 5 imparts a force to the object 16 in a first direction; and
in the second position as at fig. 4, when the strike assembly 10/12 impacts the connector 5, the connector imparts a force to the object 16 in a second direction;
wherein the first direction and the second direction are different (pushing/pulling).
Appel fails to teach a winding arranged to receive a current and thereby generate a magnetic field; or that the magnetic field generated by the winding causes the strike assembly to move so as to impact the connector. Rather, Appel teaches a functionally equivalent pneumatic mechanism for causing the strike assembly to impact the connector. Further, Appel fails to teach the impactor being arranged to determine use data comprising one or more of: a bone quality; an implant stability; an impact force; the difference between an impact force and a desired force; an impact frequency; a user of the device; or a hoop stress.
Grunig teaches a surgical percussive tool for creating impact to a tool bit holder. (abstract). Grunig further teaches that pneumatic and electromagnetic drive are functionally equivalent mechanisms for powering the impacts. (col. 3, lines 7-19)
Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to select an electromagnetic drive means to drive the impacts of the Appel device based on the Grunig teaching.
The combination of Appel and Grunig, while providing for the functional equivalence of the two drive mechanisms, continues to fail to provide for the particular claimed structure of a winding to create a magnetic field to cause impacts. Such is considered essentially inherent in an electromagnetic mechanism, but it will be shown that such structures are known in the art:
Bittenson teaches an orthopedic impactor including a winding 138 which functions to create a magnetic field to drive a strike assembly 136 to impact a connector 124. Bittenson further teaches sensors and control means for determining impact frequency [0041], [0060].
It would have been obvious to one with ordinary skill in the art at the time of the invention to have used the Bittenson arrangement including control and sensing means to drive the Appel device as modified in view of the Grunig teaching. One would have done so in order to achieve the electromagnetically driven impact tool that Grunig suggested as a functionally equivalent to a pneumatic impactor and provide means for selectively improving output impacts of the Appel device.
Allowable Subject Matter
Claims 13-15 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.
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