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 Arguments
Applicant's arguments filed December 5th, 2025 have been fully considered but they are not persuasive. Applicant argues that Zurschmiede et al. fails to teach or disclose the limitation of “the bone plate, at least in a portion comprising the receiving opening, and the bone anchor, at least in a portion comprising the anchor head, are each made of a magnesium alloy”. The Examiner respectfully disagrees with this assertion, Zurschmiede et al. expressly teaches that both the bone plate and the bone screw can be made of magnesium as set forth in ¶39 as well as the magnesium material being alloyed using carbon or nitrogen diffused into the surface of the magnesium creating an alloy. This is done to make the interstitial solid solution harder than the base material to increase wear resistance (¶32) without sacrificing toughness (¶32). The magnesium is considered the hardenable material as ¶39 sets forth that the monolithic metal (¶32) can be magnesium (¶39). Regarding Applicant’s arguments/copilot conversation the Examiner stands by their position that Zurschmiede discloses a magnesium alloy (¶39) osteosynthesis system (3 + 5) produced by cold forming (¶32) with methods classified into major groups including squeezing; wherein rotary swaging is a known method of squeezing. Applicant’s AI conversation affirms this position as it declares that rotary swaging (a form of hammer which is cold forming via squeezing) develops different material characteristics than other forms of cold forming see page 13 of arguments. As a result, Applicant’s arguments and remarks are not found persuasive to overcome the prior art and rejections of record.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-12 and 14-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zurschmiede et al. (US 2021/0369312).
Regarding claim 1, an osteosynthesis system with a bone plate (3), which has at least one receiving opening (11), and with a bone anchor (5), which comprises an anchor head (23), the anchor head being designed to be fixed in the receiving opening by forming a form- fitting and/or frictional connection with the bone plate (¶41), characterized in that the bone plate, at least in a portion comprising the receiving opening, and the bone anchor, at least in a portion comprising the anchor head, are each made of a magnesium alloy (¶33), the magnesium alloy of the bone anchor having a different hardness to the magnesium alloy of the bone plate (¶31).
Regarding 2, Zurschmiede et al. characterized in that the magnesium alloy of the bone anchor has a higher hardness than the magnesium alloy of the bone plate (¶31).
Regarding claim 3, Zurschmiede et al. characterized in that the magnesium alloy with higher hardness has a material structure achieved at least in one step by cold forming (¶32).
Regarding claim 7, Zurschmiede et al. disclose the receiving opening in an initial state does not have a connecting structure complementary to a connecting structure of the anchor head, or the anchor head in an initial state does not have a connecting structure complementary to a connecting structure of the receiving opening (figures 9-15, ¶41). Regarding claim 8, Zurschmiede et al. the connecting structure of the anchor head and/or the connecting structure of the receiving opening comprises or is a thread (27, figure 6, ¶27, ¶41).
Regarding claim 9, Zurschmiede et al. the receiving opening in the initial state is thread-free or is provided with a thread that is not complementary to the thread of the anchor head, or the anchor head in the initial state is thread-free or is provided with a thread that is not complementary to the thread of the receiving opening (¶27, ¶41). Regarding claim 10, Zurschmiede et al. the bone anchor has an anchor shaft with a shaft thread (25, figure 6).
Regarding claim 11, Zurschmiede et al. disclose that a/the thread of the anchor head and the shaft thread have different thread parameters (figure 6, different pitches and diameters).
Regarding claim 12, Zurschmiede et al. disclose there is a coating on a main body made of the respective magnesium alloy on the bone plate, at least in a portion comprising the receiving opening, and/or on the bone anchor, at least in a portion comprising the anchor head (¶40).
Regarding claim 14, Zurschmiede et al. disclose the receiving opening and/or the anchor head has/have a conical basic shape (figures 9-10).
Regarding claim 15, Zurschmiede et al. disclose the receiving opening and the anchor head have conical basic shapes with different conicities (¶29-30, ¶41).
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Zurschmiede et al. (US 2021/0369312).
Regarding claim 4, The claimed phrases “by rotary swaging” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. With regard to claim 4, it is noted that the device of Zurschmiede et al. appears to be substantially identical to the device claimed, where Zurschmiede discloses a magnesium alloy (¶39) osteosynthesis system (3 + 5) produced by cold forming (¶32) with methods classified into major groups including squeezing; wherein rotary swaging is a known method of squeezing, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983). Regarding claim 5, Zurschmiede et al. discloses the claimed invention including that both the bone plate and bone anchor are formed of the same material, magnesium alloy (¶33), but fails to expressly teach or discloses they have the same chemical composition. It would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the bone plate and bone anchor to have the same chemical composition as it simplifies manufacturing by requiring the entire device to be made up of a single material (magnesium alloy) having the same chemical composition versus a system with a bone plate and bone anchor of different magnesium alloy chemical compositions.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zurschmiede et al. (US 2021/0369312) as applied to claim 1 above, and further in view of Burns et al. (US 2007/0162019). Regarding claim 6, Zurschmiede et al. disclose the claimed invention except for the express teaching that the magnesium alloy of the bone plate and/or the magnesium alloy of the bone anchor is/are resorbable.
Burns et al. disclose the use of resorbable magnesium alloy in the construction of bone plates and bone anchors (¶6, ¶39, ¶44) as it is a known material for use in fracture fixation/bone stabilization applications.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the magnesium alloy of Zurschmiede et al. to be resorbable as taught by Burns et al. as it is a known material for use in fracture fixation/bone stabilization applications.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zurschmiede et al. (US 2021/0369312) as applied to claim 12 above, and further in view of Witte et al. (US 2011/0313527).
Regarding claim 13, Zurschmiede et al. disclose the claimed invention except for the coating comprises or is an oxide layer and/or a phosphate layer. Witte et al. disclose the application of a phosphate layer (“hydroxyapatite” ¶31, ¶54)on a head of a bone anchor (¶31, ¶54) as it helps induce bone growth.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the bone anchor of Zurschmiede et al. to include a phosphate layer as taught by Witte et al. as it helps induce bone growth thereby yielding better acceptance and bone fixation.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zurschmiede et al. (US 2021/0369312) as applied to claim 12 above, and further in view of Kopp et al. (WO 2015/090267 A1).
Regarding claims 16 and 17, Zurschmiede et al. disclose the claimed invention except for the coating comprises a magnesium oxide layer produced by plasma electrolytic oxidation. Kopp et al. the use of plasma electrolytic oxidation (Page 4, lines 4-18) to form a magnesium oxide later (Page 4, lines 7-18) as this provides the magnesium alloy implant with a protective coating having good wear, oxidation, erosion and corrosion resistance (Page 13, lines 7-13 and Page 18, lines 5-10). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have formed the coating of a magnesium oxide layer produced by plasma electrolytic oxidation as taught by Kopp et al. as this provides the magnesium alloy implant with a protective coating having good wear, oxidation, erosion and corrosion resistance.
Regarding claim 18, Zurschmiede et al. disclose the magnesium (¶39) alloy (¶32) with higher hardness has a material structure achieved at least in one step by cold forming (¶32); and there is a plate coating on the bone plate, at least in a portion comprising the receiving opening, the plate coating made of the magnesium alloy of the bone plate, and/or there is an anchor coating on the bone anchor (¶40), at least in a portion comprising the anchor head (¶40). However, Zurschmiede et al. fail to expressly teach or disclose the anchor coating is made of the magnesium alloy of the anchor head. Kopp et al. the use of plasma electrolytic oxidation (Page 4, lines 4-18) to form a magnesium oxide later (Page 4, lines 7-18) as this provides the magnesium alloy implant with a protective coating having good wear, oxidation, erosion and corrosion resistance (Page 13, lines 7-13 and Page 18, lines 5-10). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have formed the coating of a magnesium oxide layer produced by plasma electrolytic oxidation as taught by Kopp et al. as this provides the magnesium alloy implant with a protective coating having good wear, oxidation, erosion and corrosion resistance.
Regarding claim 19, Zurschmiede et al. disclose the magnesium (¶39) alloy (¶32) with higher hardness has a material structure achieved at least in one step by cold forming (¶32); the magnesium alloys of the bone plate on the one hand and of the bone anchor on the other hand have the same chemical composition (¶33, “plate and/or screw” ¶39); and there is a plate coating on the bone plate, at least in a portion comprising the receiving opening, the plate coating made of the magnesium alloy of the bone plate, and/or there is an anchor coating on the bone anchor (¶40), at least in a portion comprising the anchor head (¶40).
However, Zurschmiede et al. fail to expressly teach or disclose the anchor coating is made of the magnesium alloy of the anchor head. Kopp et al. the use of plasma electrolytic oxidation (Page 4, lines 4-18) to form a magnesium oxide later (Page 4, lines 7-18) as this provides the magnesium alloy implant with a protective coating having good wear, oxidation, erosion and corrosion resistance (Page 13, lines 7-13 and Page 18, lines 5-10). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have formed the coating of a magnesium oxide layer produced by plasma electrolytic oxidation as taught by Kopp et al. as this provides the magnesium alloy implant with a protective coating having good wear, oxidation, erosion and corrosion resistance.
Regarding claim 20, Zurschmiede et al. the magnesium (¶39) alloy (¶32) with higher hardness has a material structure achieved at least in one step by cold forming (¶32); the magnesium alloys of the bone plate on the one hand and of the bone anchor on the other hand have the same chemical composition (¶33, “plate and/or screw” ¶39); there is a plate coating on the bone plate, at least in a portion comprising the receiving opening, the plate coating made of the magnesium alloy of the bone plate, and/or there is an anchor coating on the bone anchor (¶40), at least in a portion comprising the anchor head (¶40), wherein the anchor coating is made of the magnesium alloy of the anchor head (¶40). However, Zurschmiede et al. fail to expressly teach or disclose the coating is made of the magnesium alloy. Kopp et al. the use of plasma electrolytic oxidation (Page 4, lines 4-18) to form a magnesium oxide later (Page 4, lines 7-18) as this provides the magnesium alloy implant with a protective coating having good wear, oxidation, erosion and corrosion resistance (Page 13, lines 7-13 and Page 18, lines 5-10). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have formed the coating of a magnesium oxide layer produced by plasma electrolytic oxidation as taught by Kopp et al. as this provides the magnesium alloy implant with a protective coating having good wear, oxidation, erosion and corrosion resistance.
Conclusion
THIS ACTION IS MADE FINAL. 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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619