DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the amendments received after a Non-Final Rejection on 16 June 2026. Claims 1-18 are currently pending.
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.
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.
Claims 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Naylor et al. (International Publication WO 2021/130372) in view of Bagga et al. (U.S. Patent 7,544,196).
Naylor et al. disclose (as to part of claim 13) an orthopaedic surgical system (see Figures 2 and 4A-4E) capable of being used in a direct anterior approach orthopaedic surgical hip replacement procedure (see Figure 6, and page 12, lines 12-23) on a patient's femur (110) comprising a proximal guide instrument (160) having an elongated post (164) having a bore (172) formed therein, the bore extending from a superior end (i.e. end defining 176) of the elongated post to an inferior end (i.e. end defining 174) of the elongated post and having a common diameter (i.e. smaller diameter of 172 defined between 174 and 176) throughout its entire length (see Figure 4C), and a neck (i.e. neck defined by portion of 160 defining 190, see Figure 4A) extending medially from the elongated post, an insertion instrument (131) having a handle (132) at its proximal end (i.e. end defining 132), a threaded distal end (134), and an elongated shaft (136) extending distally away from the handle to the threaded distal end, the elongated shaft having a diameter (i.e. diameter as best seen in Figure 3) that is capable of being slidingly received in the bore of the proximal guide instrument (see page 8, lines 17-20) such that the proximal guide instrument is free to slide along the elongated shaft (i.e. prior to 152 being releasably received within 178, 160 is fully capable of freely sliding along 131, see page 10, lines 10-20), and a cement restrictor component (150) capable of being threaded onto the threaded distal end of the insertion instrument (see page 8, lines 12-20), wherein (as to claim 16) the cement restrictor component is capable of comprising a cement restrictor trial component (see column 13, line 26 – column 14, line 9), wherein (as to claim 17) the cement restrictor component comprises a cement restrictor implant component (see page 14, line 11 – page 15, line 2), and wherein (as to claim 18) the superior end of the post of the proximal guide instrument defines a planar surface (i.e. top-most surface as best seen in Figure 4E), the elongated shaft of the insertion instrument has a depth stop (138) secured thereto at a location (i.e. location as best seen in Figure 3) between the handle of the insertion instrument and the threaded distal end of the insertion instrument, and a distal-most surface (i.e. surface defined by 139) of the depth stop defines a planar annular surface (i.e. surface as best seen in Figure 3) having a diameter that is larger than the common diameter of the bore of the proximal guide instrument (i.e. so that 138 does not enter 176) (see Figures 2-7, and page 8, line 12 – page 15, line 22).
Naylor et al. disclose the claimed invention except for wherein (as to the remainder of claim 13) the elongate shaft is flexible, wherein (as to claim 14) the flexible elongated shaft is constructed of a superelastic metal, and wherein (as to claim 15) the flexible elongated shaft is constructed of a nickel titanium alloy.
Bagga et al. teach the use of an instrument (e.g. a catheter or a reamer) capable of being use do deliver a material to an anatomical structure, wherein the instrument is capable of being made from a shape memory alloy (i.e. nitinol, which is a superelastic material) such that the catheter is flexible for maneuvering through the anatomical structure (see column 7, line 56 – column 8, line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Naylor et al. with wherein the elongate shaft is flexible, wherein the flexible elongated shaft is constructed of a superelastic metal, and wherein the flexible elongated shaft is constructed of a nickel titanium alloy in view of Bagga et al. in order to provide a well-known, obvious means for maneuvering the insertion instrument through the intramedullary canal to precisely deliver the cement.
Allowable Subject Matter
Claims 1-12 are allowed.
The following is a statement of reasons for the indication of allowable subject matter. Claims 1-12 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, in combination with the underlined limitations below, the following:
Regarding at least claim 1, a method of installing a cement restrictor component during performance of a direct anterior approach orthopaedic surgical hip replacement procedure on a patient's femur, comprising sliding an elongated shaft of an insertion instrument through an elongated bore of a proximal guide instrument, the insertion instrument having a handle on its proximal end and the proximal guide instrument having an elongated post through which the bore extends and a neck extending medially from the elongated post, securing the cement restrictor component onto a distal end of the insertion instrument so as to slidably capture the proximal guide instrument on the elongated shaft between the handle of the insertion instrument and the cement restrictor component, advancing the cement restrictor component through a surgically-prepared proximal end of the patient's femur and into an intramedullary canal of the patient's femur, while the cement restrictor component is located in the intramedullary canal, sliding the proximal guide instrument along the shaft of the insertion instrument distally toward the cement restrictor component such that the post and the neck of the proximal guide instrument are frictionally secured in the surgically-prepared proximal end of the patient's femur, and sliding the shaft of the insertion instrument relative to the secured proximal guide instrument such that the cement restrictor component is advanced distally into the intramedullary canal of the patient's femur to a desired depth.
Regarding at least claim 8, a method of installing a cement restrictor implant component during performance of a direct anterior approach orthopaedic surgical hip replacement procedure on a patient's femur, comprising sliding an elongated shaft of an insertion instrument through an elongated bore of a proximal guide instrument, the insertion instrument having a handle on its proximal end and the proximal guide instrument having an elongated post through which the bore extends and a neck extending medially from the elongated post, securing the cement restrictor implant component onto a distal end of the insertion instrument so as to slidably capture the proximal guide instrument on the elongated shaft between the handle of the insertion instrument and the cement restrictor implant component, advancing the cement restrictor implant component through a surgically-prepared proximal end of the patient's femur and into an intramedullary canal of the patient's femur, while the cement restrictor implant component is located in the intramedullary canal, sliding the proximal guide instrument along the shaft of the insertion instrument such that the post and the neck of the proximal guide instrument are frictionally secured in the surgically-prepared proximal end of the patient's femur, sliding the shaft of the insertion instrument distally into the intramedullary canal relative to the secured proximal guide instrument such that the cement restrictor implant component is advanced distally into the intramedullary canal of the patient's femur to a desired depth, and unsecuring the cement restrictor implant component from the distal end of the insertion instrument once the cement restrictor implant component has been advanced to the desired depth so as to implant the cement restrictor implant component at the desired depth.
Response to Arguments
The applicant's arguments with respect to claims 13-18 have been fully considered but they are not persuasive.
On numbered pages 14 and 15 of the arguments/remarks, the applicant argues that Naylor et al. fail to disclose 1) the bore “having a common diameter throughout its entire length” and 2) the proximal guide instrument being “free to slide along the flexible elongated shaft.” The examiner respectfully disagrees.
Regarding 1), claim 13 merely requires “the bore...having a common diameter throughout its entire length.” As stated above, it is the examiner’s position that the bore defines a “common diameter.” The applicant further states that the tapered cavity 178 has at least four different diameters along the length thereof. The examiner does not disagree. Due to the use of open-ended transitional phrases, such as “comprising” and “having,” claim 13 does not exclude additional, unrecited elements (see MPEP 2111.03(I). Given this, the bore does define a “common diameter.” An annotated Figure is being provided below for clarity.
PNG
media_image1.png
312
216
media_image1.png
Greyscale
Regarding 2), as stated in the rejection above, prior to 152 being releasably received within 178, 160 is fully capable of freely sliding along 131. Therefore, it is the examiner’s position that Naylor et al. disclose the claimed limitation/invention.
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 LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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, Kevin Truong can be reached 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
Prosecution Insights