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 .
Status of Claims
This office action is responsive to the amendment filed on 02/10/2026. As directed by the amendment: claim 10 has been amended, claims 14 and 15 have been cancelled, no new claims have been added, and claims 1-9 remain withdrawn from consideration as being drawn to a non-elected invention. Therefore, claim 10 is presently examined in the current Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 10 sets forth the parameter of “a solid polymer sheet applied to…” (emphasis added), on line 12; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “solid”. Specifically, does the term “solid” mean the polymer is in a solid state, as opposed to a liquid or gaseous state, or does it mean the polymer is a continuous sheet, as opposed to strips or portions of sheets, or does it mean something else completely different. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Swords (US Patent No. 7,655,047), as previously disclosed, in view of Kraus et al. (Magnesium alloys for temporary implants in osteosynthesis: In vivo studies of their degradation and interaction with bone; Acta Biomaterialia 8; 2012; pgs. 1230-1238), as previously disclosed, hereinafter Kraus, and Oepen et al. (US PG Pub. 2005/0273104), as previously disclosed, hereinafter Oepen.
Regarding claim 10, Swords discloses a occlusive reinforced polymer craniofacial bone fixation device (500), illustrated in Figure 20, comprising an occlusive reinforced polymer composite structured for sung fit over a concave shape of a craniofacial bone (178), illustrated in Figures 15 and 20 (Column 3, Lines 14-16, 64-65 & Column 7, Lines 22-33), comprising a framework (20) selected from a group consisting of a mesh, strut and/or strut-style support, comprising a single mass of surgical grade metal in a form of a sheet, comprising an upper surface; a lower surface; and pores/open spaces formed in the upper and lower surfaces; and a solid polymer sheet (25) applied to one or more of the upper and lower surfaces of the framework (20), the polymer sheet (25) occludes the pores/open spaces of the framework (20), wherein the combination of the framework (20) and the polymer (25) occluding the pores/open spaces forms the craniofacial bone fixation device, illustrated in Figures 1-4, 15 and 20 (Column 4, Lines 22-41, 60-62); but does not specifically disclose the single mass of surgical grade metal, of the framework, is magnesium or a magnesium alloy, and the polymer, of the polymer sheet, is selected from the group consisting of poly(lactic-co- glycolic acid), poly-L-lactic acid, poly-D- lactic acid, polyethylene glycol, and blends and mixtures thereof.
However, Kraus teaches that it is known in the art for hard tissue/bone implants to comprise magnesium/magnesium alloys since it is an ideal material due to: its elastic properties resembling that of bone, it exhibiting good biocompatibility, and enhanced bone regeneration; additionally, due to the degradability of magnesium/magnesium alloys in physiological environments, there would be no need for additional intervention/surgery to remove a magnesium/magnesium alloy implant after tissue healing, thereby reducing morbidity related multiple surgeries and also reducing cost (Kraus: pg.1230, Introduction section, 1st paragraph). Furthermore, Oepen teaches that it is known in the art that magnesium can be highly reactive with bodily fluids, and therefore a biodegradable polymer, such as poly(lactic-co- glycolic acid), poly-L-lactic acid, poly-D- lactic acid, and combinations/mixtures thereof, can be used with/coated on magnesium/a implant comprising magnesium in order to shield/protect the magnesium from fast degradation and/or to control/slow down the degradation of magnesium (Oepen: [0038] & [0041], Last 7 Lines).
In view of the teachings of Kraus and Oepen, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the sheet of single mass of surgical grade metal, of the framework of the device of Swords, to be magnesium/magnesium alloy, due to its ideal properties such as: elastic properties resembling that of bone, exhibiting good biocompatibility, enhancing bone regeneration, and the fact that its degradable in a physiological environment, thereby avoiding additional intervention/surgery for removal and reducing morbidity related to multiple surgeries and reducing cost, as taught by Kraus; and further for the polymer to be poly(lactic-co- glycolic acid), poly-L-lactic acid, poly-D- lactic acid and blends and mixtures thereof, in order to shield/protect the magnesium alloy from fast degradation and/or control/slow down the degradation of the magnesium alloy, as taught by Oepen; thereby forming a biodegradable, occlusive, magnesium-reinforced polymer craniofacial bone fixation device, which allows the polymer sheet to release magnesium to a periosteal interface. Furthermore, it is also to be noted that it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive. Applicant argues the rejection of independent claim 10 as being unpatentable over Swords in view of Kraus and Oepen, arguing the use of Kraus to teach that magnesium is a well-known metal used in the art. Applicant argues that degradation profiles and hydrogen gas formation, of magnesium alloys, is dependent on the selected magnesium alloy and the location the alloy is implanted; and since Kraus only discloses studies of two types of magnesium alloys in one implantation site/rat femur “Kraus would not be obviously applicable to predict the degradation rate and hydrogen bubble release profile of the claimed magnesium-reinforced polymer dental/craniofacial bone fixation device” (as stated in the Declaration of Dr. Charles Sfeir). Applicant further states that based on “experimental observations and results”, of Kraus, “there would be no motivation for one having ordinary skill in the art to replace the titanium metal in Swords with the magnesium metal in Kraus”. Examiner respectfully disagrees with Applicant’s assertions. Firstly, it is to be noted that the prior art of Kraus was used to teach that it is general knowledge, in the art of hard tissue/bone implants, that magnesium/magnesium alloy is a well-known material/metal used to form such implants, as disclosed in the introduction section of Kraus. Specifically, it is stated that magnesium/magnesium alloy is an ideal material used in hard tissue/bone implants due to multiple reasons/advantages, such as: having elastic properties resembling that of bone, exhibiting good biocompatibility, enhanced bone regeneration and, due to the degradability of magnesium/magnesium alloys in physiological environments, no need for additional intervention/surgery to remove a magnesium/magnesium alloy implant after tissue healing, thereby reducing morbidity related multiple surgeries and also reducing cost (Kraus: pg.1230, Introduction section, 1st paragraph). To further clarify, Kraus was not used to teach specific magnesium alloys, i.e. ZX50 and/or WZ21, which were used in the study/studies of Kraus; instead, Kraus was merely used to teach that it is well-known in the art to use magnesium/magnesium alloy in hard tissue/bone implants due to the advantages mentioned above. Secondly, regarding Applicant assertion that “Kraus acknowledges unfavorable results due to substantial hydrogen gas accumulations” and there would be no motivation to replace the titanium metal in Swords with the magnesium metal in Kraus “Based on the foregoing experimental observations and results”; it seems Applicant is only considering/looking at one of the two magnesium alloys disclosed/studied by Kraus, specifically ZX50 magnesium alloy. However, the other magnesium alloy disclosed/studied in Kraus, WZ21 magnesium alloy, was found to have a moderate hydrogen gas release which could be well tolerated/carried away by the body, and would be an ideal magnesium alloy material with good mechanical properties, and “newly formed bone entered tight connection to the implant surface” (Kraus: pg. 1233, 2nd Column, Lines 4-13; pg. 1236, 2nd Column, Lines 11-13 & pg. 1237, 2nd Column, Lines 13-16). Moreover, it is also to be noted that neither the claim, nor the originally filed specification of the current application at hand, disclose a specific magnesium alloy which would be required/ideal for a dental/craniofacial bone fixation device, instead just disclosing magnesium/magnesium alloy in general. Thus, Applicant’s argument that there would be no motivation to combine/reasonable expectation of success, is not found to be persuasive since Kraus clearly teaches multiple advantages/motivations to use magnesium/magnesium alloy in hard tissue/bone implants; thereby being obvious to one having ordinary skill in the art before the effective filing date of the invention for the titanium framework, of the device of Swords, to be modified to comprise magnesium/magnesium alloy, due to its ideal properties such as: elastic properties resembling that of bone, exhibiting good biocompatibility, enhancing bone regeneration, and the fact that its degradable in a physiological environment, thereby avoiding additional intervention/surgery for removal and reducing morbidity related to multiple surgeries and reducing cost, as taught by Kraus. Therefore, the rejection of independent claim 10 as being unpatentable over Swords in view of Kraus and Oepen is deemed to be proper since all the structural limitations set forth in the claim are taught; hence, the rejection stands.
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.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 02/26/2026