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 .
Response to Applicant’s interview
The Applicant’s representative called the Examiner to question why the Examiner did not address the new limitations to the claims filed on 05/06/26. The Examiner agrees with the Applicant’s representative that the new rejection did not address the new limitations. Therefore, below is the new rejection addressing the limitations filed on 5/06/26.
Applicant’s arguments with respect to claim(s) 1-7, 9, 11, 13-18, 22, and 23 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.
With respect to the new limitations “wherein the stem comprises a connective end adapted to be mounted to a diaphyseal segment body…” the Examiner has separated this phrase in two parts. For example, the words: “comprises a connective end” is a structural limitation and have given full weight. Therefore, the Examiner require to find a reference having a connective end. The Examiner believes the Magagnoli reference positively disclose a “connective end”, see rejection below for the full interpretation of the connective end. Secondly, the limitations: “adapted to be mounted to a diaphyseal segment body’ have been given patentable weight, however, the Examiner is just required to find a reference capable of being mounted in the diaphyseal body. Therefore, the Examiner believes the rejection of Magagnoli et al in view of Harmon et al is capable of being used in a diaphyseal body. For the reasons above, the Examiner believes that the previous rejection still reads on the claimed subject matter.
In order to overcome the rejection the Applicant’s representative must change the claimed subject matter and positively claim the diaphyseal body and where the diaphyseal body is located inside the human body.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-7, 9, 11, 13-18, 22-23, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Magagnoli et al US Patent Pub. 2020/0397587A1 in view of Harmon et al US Patent 12,336,911B2.
Magagnoli et al discloses a stem for or of an implant, the stem has a longitudinal axis and at least one recess (30) for the purpose of filing bone cement. The stem comprises a connective end (25) adapted to be mounted to a diaphyseal segment body (as shown in the figure below, the taper surface at the proximal end can be interpreted as the connective end). The at least one recess is interrupted by at least one barrier (31), and wherein the at least one recess comprises a first set of recesses and a second set of recesses (See figure below), the second set of recesses (not shown behind recesses 30 in Fig. 7A) nearer a distal end (see figure below) of the stem than the first set of recesses, wherein the first set of recesses (See figure below) comprises two or more recesses in a circumferential direction. The second set of recesses comprises two or more recesses in the circumferential direction, wherein at least one barrier (31, see figure below) is between the first set of recesses and the second set of recesses, and wherein a whole outer surface of the stem outside the recess is a cylindrical outer surface from a distal end of the stem to a connective end of the stem, and wherein the cylindrical outer surface between the connective end of the stem and a tip of the stem is NOT constant cross-section.
Harmon et al discloses an implant having multiple stems comprising different shapes. Some stems comprise a conical configuration (See Figs. 12-14) other stems comprise a full cylindrical configuration (see Figs. 15-16, 23 and 24). Each of the stems, especially, stems shown in Figs. 23 and 24, disclosed a plurality of recesses capable of receiving adhesives or bone cement for the purpose of holding the implant in place a plurality of recesses around the circumference of the stem (see col. 5, lines 53-57).
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Regarding claims 2 and 3, see figures above showing an elongated groove along the longitudinal axis of the stem and showing the barriers solidly integrated to the stem.
Regarding claims 6, 7 and 9, see figure above showing that the barrier is continuous around the circumferential perimeter of the stem.
Regarding claim 11, the stem is capable of being inserted into the intramedullary canal of a humerus.
Regarding claim 15, see each barrier 31 as a single entity.
Regarding claim 16, see Fig. 7A showing 2 barriers per stem.
Regarding claim 17, see Fig. 7A showing the barriers oriented transverse to the longitudinal axis and having an external cylindrical configuration.
Regarding claim 18, see element 29 in Fig. 7A.
Regarding claim 22, see Figure above disclosing the claimed subject matter.
Regarding claim 23, see Figure above showing the claimed subject matter.
Regarding claim 27, the at least one recess (30) is configured to support fixation in both longitudinal directions.
Regarding claim 28, see Fig. 4B, the Examiner interpreted element 12 as the adapted and element 14 as the joint replacement component.
Regarding claim 29, the stems as shown in Figs. 4A and 4B are long enough to be implanted in parts of the diaphyseal areas of long bones. Additionally, as shown in Figs. 4A and 4B the implant can be inserted between two long bones (femur and tibial bones).
Regarding claims 4 and 5, Magagnoli et al discloses the claimed invention except for a range of width lengths. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Magagnoli et al unknown recesses widths, 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. In re Aller, 105 USPQ 233.
Regarding claim 14, Magagnoli et al discloses the step of filling the recesses with bone cement, however, does not disclose the step of filling the outer surface of the stem with bone cement. It is well known in the art to fill the intramedullary canal with bone cement in addition to all the recesses in order to have a strong and immediate fixation of the implant to the patient’s bone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799
7/28/26
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