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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/4/26 was filed after the mailing date of the Non-Final Rejection on 11/04/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered 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.
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(s) 1-7 and 9-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combine disclosures of Lin et al (US 2018/0326127 A1 hereafter Lin) in view of Qi et al (US 2018/03261285 A1 hereafter Qi).
Lin discloses an iron based alloy useful as an orthopedic internal fixation implant comprising an iron matrix, a filling material, where the filling material comprising polylactic acid and where the polylactic acid has a molecular weight between 150,000 and 3,000,000 [abstract]. The iron matrix can have a groove, pore or gap or hollow inner cavity that is filled with the filling material [0025-0029]. The filling material comprises polylactic acid [0031]. The orthopedic internal fixation device is a bone screw [0057]. The device may further comprise a mesh that is filled with hydroxyapatite [0056-0057].
While Qi disclose an orthopedic fixation device comprising an iron matrix and filling materials, the reference does not disclose the exact filling materials of the instant claims. Hydroxyapatite and additional phosphate may be included [Embodiment 3], however the specific combination of the instant claims is not recited by the Lin patent. Such combination are known in the art as seen in the Qi patent.
Qi discloses an internal fixation implant comprising an iron matrix and a filling material where the filling material comprises a mixture of polylactic acid and an alkaline substance [abstract, 0010, 0017]. The polylactic acid has a molecule weight of about 200,000 [0053]. The alkaline substance such as hydroxyapatite [0010]. The alkaline substance can be a mixture of hydroxyapatite and sodium bicarbonate, calcium carbonate [0034]. The carbon content is not more than 2.11 wt% [0028]. The internal fixation implant medical device is formed by coating the filling material on the surface of the iron matrix [0048-0050]. The polylactic acid is present as poly-dl-lactic acid [0056]. Regarding the mass ratio of the metal element in the alkaline to the polylactic acid, the combination of the art is silent to this specific ratio, however the totality of the alkaline is at least 20% of the total filling material with special accounting for the metallic ions present in the coating [0037]. The filling mixture can comprise a mixture of hydroxyapatite and the metal alkaline compound, meeting the general conditions of the claims. Adjustments to the coating mixture are seen in the Qi reference in Embodiments I-IV where different coating thicknesses are applied to the iron alloy base. These embodiments change the components of the filling material and thereby change the strength of the implant. This type of optimization and routine experimentation is seen to be obvious to those of ordinary skill in the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable fixation implant. It would have been obvious to combine the components of Qi into the shape of a screw as seen in the Lin patent as they comprise similar components and solve the same problem of a bioresorbable implant device comprising an iron matrix and a coating mixture comprising biocompatible components. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable implant device.
Response to Arguments
Applicant’s arguments, see Remarks, filed 2/4/26, with respect to the rejection(s) of claim(s) 1-7,9-21 under 35 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
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 MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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