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 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.
Claims 1-2 and 4-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hershberger (US 2005/0234462).
Regarding claim 1, Hershberger discloses an intramedullary trial stem for bone joint surgery, the trial stem comprising an elongate intramedullary stem-shaped body (114 + 116), and at its proximal end a part of an implant articulating coupler (116), wherein the trial stem is removably engageable by a fastener part (e.g. female threads of 116) with a rod (e.g. male threads of 112) extending from a handle (e.g. 112), and wherein the body is configured for friction fitting in an intramedullary cavity so that it is suitable for use as a trial or permanent intramedullary implant stem after disengagement by the fastener part from the rod (capable as the body acts as a sizer/trial see ¶20-21 in view of ¶23).
Regarding claim 2, Hershberger discloses the fastener part comprises a threaded socket (figures 4-5, ¶22).
Regarding claim 4, Hershberger disclose the body comprises broaching teeth so that the trial stem forms a broach when fastened to a handle rod (¶22, figures 4-5).
Regarding claim 5, Hershberger disclose the broach comprising a handle (122), a rod (112) extending distally, and a broach head (114 + 116) with broaching teeth (¶22, figures 4-5), wherein the broach head comprises at its proximal end a part of an implant articulating coupler (116), the broach head is removably engageable with the rod by a fastener (male/female threading between 112 and 116, ¶22), and the broach head is configured for friction fitting in an intramedullary cavity so that it is suitable for use as a trial stem or permanent intramedullary implant after disengagement by the fastener from the rod (capable as the body acts as a sizer/trial see ¶20-21 in view of ¶23).
Regarding claim 6, Hershberger disclose the fastener comprises a proximally facing threaded socket (see figure below, ¶22) in the head and a threaded distal end of the handle rod (see figure below).
Regarding claim 7, Hershberger disclose the fastener comprises a proximally facing threaded socket (see figure below, ¶22) in the head and a threaded distal end of the handle rod (see figure below); and wherein at least one of the handle rod and the head have a visual indicator to indicate the extent of fastener thread engagement (the visual indicator being the amount of threading exposed between the base of 116 and “bottom” of handle 122).
Regarding claim 8, Hershberger disclose the fastener comprises a proximally facing threaded socket (see figure below, ¶22) in the head and a threaded distal end of the handle rod (see figure below); and wherein at least one of the handle rod and the head have a visual indicator to indicate the extent of fastener thread engagement (the visual indicator being the amount of threading exposed between the base of 116 and “bottom” of handle 122); and the handle rod and the head each have a visible indicator (when 122 is seat flush or nearly flush on the top of threaded opening 116 and cannot be further threaded as well as the remaining amount of threading between 116 and 122).
Regarding claim 9, Hershberger disclose the fastener comprises a proximally facing threaded socket (see figure below, ¶22) in the head and a threaded distal end of the handle rod (see figure below); and wherein at least one of the handle rod and the head have a visual indicator to indicate the extent of fastener thread engagement (the visual indicator being the amount of threading exposed between the base of 116 and “bottom” of handle 122); and the handle rod and the head each have a visible indicator (when 122 is seat flush or nearly flush on the top of threaded opening 116 and cannot be further threaded as well as the remaining amount of threading between 116 and 122); and the indicators are positioned so that when they are aligned close to full engagement the alignment indicates a particular portion of the last turn remaining (the remaining amount of male threading to be seated in female threading of 116 indicates that amount of turn remaining).
Regarding claim 10, Hershberger disclose the fastener comprises a proximally facing threaded socket (see figure below, ¶22) in the head and a threaded distal end of the handle rod (see figure below); and wherein at least one of the handle rod and the head have a visual indicator to indicate the extent of fastener thread engagement (the visual indicator being the amount of threading exposed between the base of 116 and “bottom” of handle 122); and the handle rod and the head each have a visible indicator (when 122 is seat flush or nearly flush on the top of threaded opening 116 and cannot be further threaded as well as the remaining amount of threading between 116 and 122); and the indicators are positioned so that when they are aligned close to full engagement the alignment indicates a particular portion of the last turn remaining (the remaining amount of male threading to be seated in female threading of 116 indicates that amount of turn remaining), wherein the portion is less than 25% of a turn (this occurs at the moment less than 25% of the last turn is remaining).
Regarding claim 11, Hershberger disclose the fastener comprises a proximally facing threaded socket (see figure below, ¶22) in the head and a threaded distal end of the handle rod (see figure below); and wherein at least one of the handle rod and the head have a visual indicator to indicate the extent of fastener thread engagement (the visual indicator being the amount of threading exposed between the base of 116 and “bottom” of handle 122); and the handle rod and the head each have a visible indicator (when 122 is seat flush or nearly flush on the top of threaded opening 116 and cannot be further threaded as well as the remaining amount of threading between 116 and 122); and the indicators are positioned so that when they are aligned close to full engagement the alignment indicates a particular portion of the last turn remaining wherein the portion is in the range of 10% to 15% of a turn (the remaining amount of male threading to be seated in female threading of 116 indicates that amount of turn remaining; this occurs at when the portion remaining is in the range of 10-15% of the last turn).
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Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stockmans et al. (US 2022/0218492).
Regarding claim 1, Stockmans et al. disclose an intramedullary trial stem for bone joint surgery, the trial stem comprising an elongate intramedullary stem-shaped body (100 + 110), and at its proximal end a part of an implant articulating coupler (100), wherein the trial stem is removably engageable by a fastener part (e.g. 202) with a rod (e.g. 201) extending from a handle (e.g. 203), and wherein the body is configured for friction fitting in an intramedullary cavity so that it is suitable for use as a trial or permanent intramedullary implant stem after disengagement by the fastener part from the rod (¶93).
Regarding claim 3, Stockmans et al. disclose the articulating part is a ball socket (103, figure 6, ¶57, ¶59).
Allowable Subject Matter
Claim 17 is allowed.
Claims 12-16 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.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 17, none of the cited art (see attached PTO-892) in combination or alone render obvious or anticipate the entirety of the claim. Specifically, Hershberger and Stockmans et al. fail to teach or disclose the final step of “connecting a proximal implant component to the broach head so that the broach head performs the function of a trial implant or a permanent implant.
Regarding claims 12-16, the articulating coupler (116 of Hershberger) does not possess a proximally facing socket for engagement with a ball. Rather, the socket of Hershberger appear to be generally cylindrical in shape for passage and engagement of handle 112 which is also generally cylindrical in shape. Changing the shape of the proximally facing socket could render the handle unable to pass therethrough for threadably coupling 112 to 116, see ¶22)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00. 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, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619