DETAILED ACTION
This office action is responsive to the response to restriction requirement of May 20, 2026. The claims of May 20, 2026, are under consideration. Claims 1-21 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 .
Election/Restrictions
Applicant’s election without traverse of Species 2 and subspecies B in the reply filed on May 20, 2026, is acknowledged. These species are encompassed by claims 1-10 and 18-21.
Claims 11-17 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 20, 2026.
Upon review of the elected claims: Examiner now understands claim 21 to be a distinct invention from claims 1-10 and 18-20. Examiner apologizes for this late understanding.
Examiner made a phone call to applicant’s representative, Ms. Elexis Jones, on September 4, 2026, to explain this new understanding. It was agreed by Ms. Jones on September 8, 2026, to further permit withdrawal of claim 21 from prosecution at this time for the following rationale:
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-10 and 18-20, drawn to a method, classified in A61B2017/564.
II. Claim 21, drawn to a femoral stem, classified in A61F2/36.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process, such as a surgical procedure in which a venting procedure is not carried out.
Therefore, claims 11-17 and 21, are now withdrawn. Examiner understands applicant wishes to maintain claim 21 as being eligible for rejoinder through prosecution and is happy to work with applicant to ensure such occurs when appropriate.
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) 1-4 and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over “The McMinn Center” (hereinafter “McMinn”). A teaching reference Brown (US 4,357,716) is referred to in making this rejection.
The McMinn reference is a youtube video posted Aug 21, 2013, titled “Mini Incision Birmingham Hip Resurfacing (BHR) procedure, broadcast via satellite to the USA, 2004”. The video was retrieved on September 1, 2026, at: www.youtube.com/watch?v=3VO2kE86WIY
Regarding claims 1, 2 and 10, McMinn teaches a method of preparing a femur (entire video up to about minute 38 relates to preparation of the femur and/or acetabulum for a hip surgery) for insertion of a prosthetic femoral component (seen being inserted at about minutes 38-40), the femur comprising a femoral head, a femoral neck, a trochanteric fossa, a greater trochanter and a femoral canal (all inherently present in standard human femoral anatomy, all present in the teaching model shown at 25:07, and all apparently present in the femur being repaired throughout the video), the method comprising:
amputating the femoral head and a portion of the femoral neck (a portion of the head and neck are amputated from the body at insertion of over-drill at about 30:25; and use of rotary cutter at 31:15, additional cutting at 32:40, and cutting with a saw and sleeve ring at 34:20; amputated surfaces seen at 34:40; additional chamfering at minute 35). Examiner understands “to amputate” to be defined as “to surgically cut of all or part of a limb or digit” (Google Define, 2026, examiner’s emphasis). Examiner takes the position that tunneling or drilling through a portion of the femoral neck is at least a partial amputation for purposes of this rejection;
excavating the trochanteric fossa (demonstrated by use of drill at 29:25, “aiming towards the center of the canal”. This is understood to be passing through the trochanteric fossa based upon where the drill is inserted into the femur as can be seen in the video, and evidenced by passage into the femoral canal as discussed in the video);
preparing the femoral canal for insertion of a vent tube (the excavation step of 29:25 and additionally attachment of tubing and insertion of the sucker at 29:45) in a vent path through an anterior portion of the femur, into the femoral canal and along an anterior cortical wall of the femoral canal to a position distal of a distal end of the prosthetic femoral component, when inserted in the femoral canal (the vent tube is distal to the cap which is inserted later in the video around minutes 38-40); and
inserting a vent tube at 29:45 into the vent path such that a tip of the vent tube is located in soft cancellous bone in the femoral canal, for use in venting the femoral canal during subsequent insertion of the prosthetic femoral component (clearly discussed being in the canal, distal to the implant, and demonstrated in functionality as shown and discussed at 38:05, 38:35, 39:10, 39:20-39:35; and discussed once again as removal of displaced fat and marrow in the femoral shaft being sucked out through the vent at 42:15).
It is noted that at (40:40), McMinn discusses what to do in case the hip-resurfacing procedure fails for a variety of reasons. It is suggested to switch to a procedure in which a cementless or cemented hip stem would be used in these situation. Examiner suggests that the already inserted vent from minute (29:25) would not be removed from the patient due to changing the type of implant being installed.
McMinn teaches advantages to the vent sucking from a location distal the femoral implant in that doing so prevents fat embolization into the systemic circulation (39:25) and fat and marrow from being released into general circulation of the patient (42:15).
McMinn fails to teach the femoral component being a femoral stem component; arguably fails to teach amputation of the femoral neck (depending on how applicant wishes to define “amputate”); and fails to teach preparing the femoral canal for insertion of the prosthetic femoral stem component such that a proximal end of the prosthetic femoral stem component is adjacent to a posterior cortical wall of the femoral canal, antero-medially of the excavated trochanteric fossa. It is old and well known in the art to prepare a femur for insertion of a femoral stem component. Doing so requires amputation of the head and a portion of the neck and preparation of the canal for insertion of the stem, therein. Teaching reference Brown shows that such preparation is known in femoral stem procedures. (Brown, col. 17, lines 3-20).
It would have been obvious to one with ordinary skill in the art at the time of the invention in possession of the McMinn video to use McMinn’s method to apply ventilation/suction distal the stem implant during insertion. McMinn provided rationale for inserting a stem in a procedure in which a vent was already installed (e.g. due to failure of the capping procedure) and provided advantages to venting distal to the implant (the prevention of fat embolysis in the systemic circulation). One would have done so by simply inserting the vent tubing deeper into the femoral canal to continue to have the vent distal to the stem prosthesis. One would have done so to continue to achieve the advantages of the vent (e.g. removal of displaced fat and marrow and prevention of entry of those substances into the systemic circulation) in a case where the femoral cap procedure failed, and the procedure had to be reverted to a femoral stem component.
Regarding claim 3, the step of preparing the femoral canal for insertion of the vent tube comprises creating a substantially straight vent path in the femur as at 29:25-29:45 – use of a straight drill is seen).
Regarding claim 4, the step of preparing the femoral canal for insertion of the prosthetic femoral stem component comprises using one or more vented tools (cannula and vent tubing).
Regarding claim 6, operation of a suction device attached to the vent tube is taught in the video. This is done during insertion of the component at 38:05 and would in the proposed modification also be done during inserting the prosthetic femoral stem component.
Regarding claim 7, a suction device is attached to the vent tube.
Regarding claim 8, it is old and well known to utilize imaging during the step of preparing a femoral canal for insertion of a prosthetic femoral stem component.
Regarding claim 9, the video shows the vent path appearing to include a valve in the head of the cannula (stop cock at 29:50) which is opened during the procedure to permit suction discussed at the time in the video. The vent path is clearly capable of being plugged to block entry of debris therein at certain stages of the procedure.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMinn in view of Mittelmeier et al. (US 5,788,703) and the teaching reference to Brown.
Regarding claim 20, McMinn (as modified in rejecting claim 1, above) suggests a method of implanting an uncemented prosthetic femoral stem component into a femur (this stem shown at 40:40). The prosthetic femoral stem component comprises a substantially longitudinal stem portion; and a neck portion having a longitudinal axis intersecting the longitudinal stem portion. The method includes preparing the femur for insertion of the prosthetic femoral stem component (in view of the teaching reference to Brown, as noted in rejecting claim 1) and operating a suction device whilst inserting the prosthetic femoral stem component into the femur, as cited in rejecting claim 1.
McMinn fails to teach the stem component including a vent hole extending through the longitudinal stem portion from a proximal surface to a distal tip; the vent hole comprises an enlarged portion adjacent to the proximal surface, for accommodating an end of a suction device during use; and a step of inserting a suction device into the enlarged portion of the vent hole of the prosthetic femoral stem component.
Mittelmeier teaches a femoral stem component including a vent hole at the groove formed in 4 seen receiving line 8 in fig. 3. Based on flow arrows in fig. 1 and teaching at col. 3, lines 19-21, suction is applied to these lines to draw off air and/or liquids (col. 4, lines 24-30). An end of 8 is accommodated in the proximal portion of this groove. The deepest part of the groove extends through the proximal portion and is considered enlarged relative to shallower portions of the groove.
It would have been obvious to provide McMinn with an implant having a groove formed therein as a matter of permitting accommodation of the McMinn suction tube in place during the procedure. One would have done so to simplify an insertion step of the McMinn procedure with the stem implants, and prevented inadvertent closing off of the tube by the stem as it is inserted into the femoral canal.
Allowable Subject Matter
Claim 5 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.
Claims 18-19 are allowed. The combination of method steps is beyond what is taught or rendered obvious by the art of record. Mittelmeier does teach use of a cement restrictor, but the additional steps of interaction between the tube and the implant, the use of an extension tube, and use of suction during insertion of cement to cure and fix the implant are beyond what is suggested by Mittelmeier or McMinn.
Conclusion
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
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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