DETAILED ACTION
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 Request for Continued Examination (RCE) received on 27 April 2026. Claims 1-9, 12-24 and 27-34 are currently pending.
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 April 2026 has been entered.
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 29-30 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Spievack et al. (U.S. Patent 5,871,484) in view of Lidgren (International Publication WO 2023/166161) further in view of Shinde et al. (U.S. Patent Application Publication 2023/0338066).
Spievack et al. disclose (as to part of claim 29) an orthopedic implant device (20) comprising a straight region (i.e. region defining 24, see Figure 3) comprising an external surface (i.e. surface defined by periphery of 20 as best seen in Figures 3 and 4) having a plurality of fenestrations (22), one or more concave longitudinal flutes (24) oriented parallel to a longitudinal axis (i.e. axis defined along and through center of 20) and comprising a bottom surface (i.e. surface defined adjacent 22 as best seen in Figure 4); the plurality of fenestrations through the bottom surface (see Figure 4); and a central reservoir (25) capable of being filled with at least one therapeutic (i.e. a biologically active substance) and connected to the plurality of fenestrations through the bottom surface (see Figure 4), wherein the device is capable of (see Note below regarding functional language) passively eluting (i.e. via seeping) the at least one therapeutic (i.e. a biologically active substance, see column 5, line 66 – column 6, line 3 in reference to a related embodiment), wherein (as to claim 30) the concave longitudinal flutes are radially distributed around the longitudinal axis (see Figure 4) (see column 3, lines 6-8) (see Figures 1-6, and column 2, line 57 – column 3, line 67).
Spievack et al. disclose the claimed invention except for wherein (as to part of claim 29) the central reservoir is filled with a temporary carrier loaded with the at least one therapeutic, and wherein the orthopedic implant device is capable of eluting the temporary carrier over about 40 days, and wherein (as to claim 34) the temporary carrier and the therapeutic agent are mixed.
Lidgren teaches the use of a temporary carrier (i.e. a carrier including calcium sulfate and hydroxyapatite, see page 13, lines 19-27) capable of being loaded with at least one therapeutic (i.e. gentamicin, vancomycin, or tobramycin, see page 23, lines 23-30) for use in treating/preventing bone infections (see page 27, lines 10-13), wherein a composition including the carrier/therapeutic is capable of being administered as a fluid (see claim 14), wherein the carrier/therapeutic is capable of being eluted over a timeframe of 35 days or more (see page 17, lines 17-22), and wherein the temporary carrier and the therapeutic agent are capable of being mixed (see page 18, lines 6-23).
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 invention of Spievack et al. with wherein the central reservoir is filled with a temporary carrier loaded with the at least one therapeutic, and wherein the orthopedic implant device is capable of eluting the temporary carrier over about 40 days, and wherein the temporary carrier and the therapeutic agent are mixed in view of Lidgren in order to provide a well-known, obvious means for ensuring the controlled release of an antibiotic to bone surrounding the device to decrease the likelihood of an infection to yield predictable results.
Spievack et al. in view of Lidgren disclose the claimed invention except for wherein (as to the remainder of claim 29) the device has a maximum local stress of about 350 to about 600 MPa at a global force level of 750N.
Shinde et al. teach the use of an intramedullary nail (2) and set forth that the nail configuration is a result effective variable, wherein the configuration is designed to reduce stress concentrations and increase strength of the nail (see paragraph 0054) and comprises a material capable of having desired material properties to do so (see paragraph 0042).
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 invention of Spievack et al. in view of Lidgren with wherein the device has a maximum local stress of about 350 to about 600 MPa at a global force level of 750N, for the purpose of providing a desired material to reduce stress concentrations and increase nail strength, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see In re Aller, 105 USPQ 233).
Note: Regarding functional language, "[a]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (see MPEP 2114(II)).
Allowable Subject Matter
Claims 1-9, 12-24, 27-28 and 31-33 are allowed.
The following is a statement of reasons for the indication of allowable subject matter. At least independent claims 1, 14 and 27 include limitations directed toward specific parameters (i.e. dimensional ranges of the flutes and fenestrations). As found on numbered page 10 of the arguments/remarks, it was stated that specific parameters were not selected as a result of routine experimentation. They were unexpected results found to impart the implant device with its structural integrity. These results are discussed on pages 23-24 and 31-33 of the current specification. The examiner agrees with the arguments/remarks (i.e. specifically in regards to claims 1-9, 12-24, 27-28 and 31-33), and can find no references, or reasonable combination thereof, which disclose, or suggest these parameters.
Response to Arguments
The applicant's arguments with respect to claims 29-30 and 34 have been fully considered but they are not persuasive.
As discussed in the “Allowable Subject Matter” section above, claims 1-9, 12-24, 27-28 and 31-33 have been indicated as allowable due to their inclusion of specific parameters having unexpected results found to impart the implant device with its structural integrity. Claims 29-30 and 34 do not require these parameters.
Regarding the limitation “the device has a maximum local stress of about 350 to about 600 MPa at a global force level of 750N,” the current specification (see page 9) states that the force is intended to test durability of the orthopedic implant device for permanent implantation and weight bearing. As stated above, Shinde et al. teach the use of an implantable nail comprising a material capable of having desired material properties to reduce stress concentrations and increase strength of the nail (i.e. providing motivation for the optimization of workable ranges). Furthermore, there is nothing claimed indicating that the device is “permanently” implanted. The devices as disclosed/taught by Spievack et al. and Shinde et al. are intended to be implanted such that they are subjected to the weight of a patient. Therefore, it is the examiner’s position that the rejections of claims 29-30 and 34 are proper given the current claim requirements.
Conclusion
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).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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