I. Applicant’s election without traverse of Species n, Species Ω. Species ii, and Species B in the reply filed on 8/18/2025 is acknowledged. It is further acknowledged that the Applicant believes the election reads on claims 1-10. The Examiner agrees. As a result, no claims are being withdrawn.
II. Although six translations with receipt date of 8/18/2025 appear in the record, they should be cited in an IDS.
III. 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.
Claims 1-10 are 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.
i. Passive voice statements can be indefinite. Examples are provided. Applicant should address all instances.
Example 1:
In claim 1, the limitation “wherein auxiliary components (2) are arranged at positions, close to a repaired bone surface, of the bone repair surface, of the bone repair instrument (1)” can be interpreted to mean 1. The bone repair instrument must comprise auxiliary components and the auxiliary components must be arranged at positions, close to a repaired bone surface, of the bone repair surface, of the bone repair instrument, or 2. auxiliary components are configured to be arranged at positions, close to a repaired bone surface, of the bone repair surface, of the bone repair instrument [and no auxiliary components are required, since the claim does not state that the device/instrument comprises the auxiliary components]. Interpretation 1 will be considered to hold. To eliminate guesswork, it is proposed that claim 1 positively recite that the bone repair instrument comprises the auxiliary components.
Example 2:
In claim 7, the limitation “wherein the first screw is disposed above the bone repair instrument” can be interpreted as: 1. the first screw must be disposed above the bone repair instrument, or 2. the first screw is configured to be disposed above the bone repair instrument. Interpretation 2 will hold, but to eliminate guesswork, amendment is required.
Example 3:
In claim 7, the limitation “one end of the third spring (20) is fixedly connected with a side wall,” will be interpreted to mean one end of the third spring (20) must be fixedly connected with a side wall and not “one end of the third spring (20) is configured to be fixedly connected with a side wall.” If this interpretation is correct, no amendment is required.
Example 4:
In claim 8, “an image acquisition device, disposed above the bone repair instrument” will be interpreted to mean “an image acquisition device, configured to be disposed above the bone repair instrument.” If this interpretation is correct, amendment is required.
ii. Indefiniteness:
Regarding claim 2, the limitation “the bone repair instrument (1) can be made of biomedical stainless steel, pure titanium, Ti6A14V or Ti6A17Nb” is unclear at least because it is unclear whether this means the bone repair instrument must be made of biomedical stainless steel, pure titanium, Ti6A14V or Ti6A17Nb. If instrument does not need to be made of biomedical stainless steel, pure titanium, Ti6A14V or Ti6A17Nb, then it is unclear what this can mean. The Examiner proposes that “can be” be replaced with “is” to improve clarity.
Regarding claim 7 (line 1 of the third clause) the “is disposed at one ends” appears to be a typographical error impeding clarity. The limitation “wherein the guide plate (10) is disposed at one ends, away from the first screw (6), of the moving plates (8),” is unclear since Figure 10 shows the top end of the guide plate and the bottom end of the guide plate approximately at the same orientation relative to the first screw, i.e. no single end appears to be away from the first screw.
Regarding claim 8, a definition for an “actual similarity” is provided via the claimed formula but no definition is provided for “preset similarity” in the claim. It is unclear how a “preset similarity” can be calculated for claimed step 3.
IV. 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qin et al. (CN 103908328; “Qin” herein; citations are to an English machine translation of the cited reference obtained from WIPO PATENTSCOPE).
Note: The cited disclosure is based on a machine translation of CN 103908328 obtained via WIPO PATENTSCOPE which appears to disclose the claimed subject matter and is consistent with the Written Opinion submitted in the IDS of 6/9/2023. The Office considers this translation sufficient to establish a prima facie case. If applicant believes the translation is incomplete or inaccurate, the burden rests with the applicant to provide a certified English translation to rebut this finding. The certified English translation must be prepared by a human translator (not a machine translation) and must be accompanied by a signed statement attesting to its accuracy.
Regarding claim 1, Qin discloses a fracture repair device realizing transition from mechanical fixation to biological fixation, comprising a bone repair instrument (e.g. 20), wherein auxiliary components (e.g. 210, 210’) are arranged at positions, close to a repaired bone surface, of the bone repair instrument, and each auxiliary component is made of a degradable material (e.g. “and the magnesium or magnesium alloy components 210, 210'and 210 " filling exactly all of each recess.”).
Regarding claim 2, Qin discloses the degradable material comprises: a degradable metal material or a composite material thereof or a degradable polymeric material, and the bone repair instrument is made of biomedical stainless steel, pure titanium, Ti6A14V or Ti6A17Nb (“In some embodiments, the body is made of titanium or stainless steel.”); and the degradable metal material or the composite material thereof comprises any one of magnesium or a magnesium alloy or a magnesium-based composite, zinc or a zinc alloy or a zinc-based composite, and iron or an iron alloy or an iron-based composite (e.g. “and the magnesium or magnesium alloy components 210, 210'and 210 " filling exactly all of each recess.”).
Regarding claim 4, Qin further discloses the auxiliary components comprise any one or more of a pad, a plate, and a block, wherein the pad, the plate, and the block comprise any one or more of a circular ring-shaped gasket, a plate-shaped washer, and a square cushion block (e.g. “In other embodiments, depending on the actual needs (e.g. depending on the number and position of the fracture site), the shape and number of the recess/magnesium or magnesium alloy component 110 May also vary, for example, the shape of the recess/magnesium or magnesium alloy component 110 May be changed to a substantially square, circular, elliptical or irregular shape”).
Regarding claim 5, Qin further discloses the surface of each auxiliary component is subjected to surface treatment comprising any one of micro-arc oxidation, chemical deposition, and anodization (e.g. “In order to better control the degradation rate of the magnesium or magnesium alloy, a biodegradable material coating may also be coated for the magnesium or magnesium alloy component. Methods of applying coatings are well known in the art. For example, in some embodiments, polylactic acid (PLA) and a copolymer extraction method thereof can be used, and the medical polylactic acid (PLA) can be degraded in the human body, and the final product is carbon dioxide and water, which participates in human metabolic circulation and discharge, and has good biocompatibility. Polyglycolide-lactide (PLGA) is a widely used polylactic acid copolymer, which can be obtained by copolymerizing lactic acid with glycolic acid or glycolide with lactide. In some embodiments, the PLGA coating is obtained on the surface of the magnesium or magnesium alloy part using a dip coating method, for example, PLGA may be dissolved in chloroform at 2% or 4% (mass percentage), respectively, then the magnesium or magnesium alloy part is put into solution dip coating for a period of time, which is then pulled out at a certain rate, dried, volatilized by solvent, PLGA cured to obtain a magnesium or magnesium alloy component with a PLGA coating. In some embodiments, chitosan (C8 H1 3 NO5)n (N-acetyl-2-amino-2-deoxy-D-glucose is connected in the form of a β -1,4-glycosidic bond) is a non-toxic and degradable biomaterial, the structure is similar to human bone collagen tissue, and the degradation rate is similar to PLA.”).
Regarding claim 6, Qin discloses a connection mode between the auxiliary components (2) and the bone repair instrument (1) comprises direct contact connection or pin connection (e.g. “In the embodiment shown in Figures 2A and 2B, three square recesses of the same size are provided on the body 200, the depth of the recesses being about ½ of the thickness of the body 200, and the magnesium or magnesium alloy components 210, 210'and 210 " filling exactly all of each recess”).
V. 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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Qin, as above, and further in view of Imwinkelried et al. (US 2014/0065009; “Imwinkelried” herein). Qin may or may not disclose the magnesium or magnesium alloy or magnesium-based composite comprises high purity magnesium. Imwinkelried discloses compositions comprising ultrapure magnesium having a purity of at least 99.997 wt. % and implants based on such compositions can include a bone plate (e.g. paras. [0024] and [0049]). It is considered obvious to have combined the teaching of ultrapure magnesium per Imwinkelried to the magnesium of Qin in order to provide a material suitable for a bone plate.
VI. Claims 7-10 would be allowable upon resolution of the above matters.
VII. The following is an examiner’s statement of reasons for allowance or the indication of allowable subject matter: The claims distinguish over closest prior art cited in the 892. In an exemplary prior art reference, Qin discloses a method/apparatus involving a bone repair instrument (e.g. 20) and magnesium auxiliary components (e.g. 210, 210’), but fails to disclose at least a mounting device, a double-headed screw, moving plates, and relationships thereof, as claimed. There would have been no obvious reason(s) to modify the Qin apparatus/method to satisfy at least this/these and/or each of applicant’s claimed limitations, as such modification(s) would have likely rendered the Qin method/apparatus incapable of continuing to operate/behave in the particular manner set forth within the Qin reference, which would have been strongly indicative of an application of impermissible hindsight reasoning. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
VIII. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN A. SEVILLA whose telephone number is (571)270-5621. The examiner can normally be reached on Monday through Thursday, 8:00 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTIAN A SEVILLA/ Primary Examiner, Art Unit 3775