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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 1 is objected to because of the following informalities, which Examiner notes are generally related to grammatical errors and/or inconsistencies which appear to potentially result from translation issues:
In lines 6-7, “wherein a rod required to construct an outer frame is passed through the rod hole” should read ---wherein a rod required to construct an outer frame passes through the rod hole---
In lines 8-10, “a rod fixing slot, wherein the rod fixing slot is in line with the rod hole on a side surface of the body, and provides fixing the rod by tightening the rod by inserting a first setscrew” should read ---a rod fixing slot, wherein the rod fixing slot is in line with the rod hole on a side surface of the body and provides for fixing the rod by tightening a first setscrew inserted therein---
In lines 12-13, “a pin is passed through the pin hole” should read ---a pin passes through the pin hole---
In lines 14-16, “wherein the pin fixing slot […] provides fixing the pin by tightening the pin by putting a second setscrew” should read ---wherein the pin fixing slot […] provides for fixing of the pin by tightening a second set screw inserted therein---
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1, in lines 12-13, recites “a pin is passed through the pin hole through the bone of a living thing to which the application is made” thus positively reciting “the bone of a living thing”. Examiner suggests amending this limitation to recite ---a pin passes through the pin hole and is configured to be inserted into the bone of a living thing to which the application is made--- in order to overcome this rejection.
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 1 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 1, in lines 3-5, recites “wherein the body […] has a geometric structure in more than one different shape in accordance with an anatomy of a bone to which an application is made”, which is generally unclear and does not appear to be supported by the specification, which describes various embodiments of a bone fixation apparatus having a body. In different embodiments, the body takes a different shape corresponding to the anatomy of a bone to which the apparatus is applied, e.g. various ring shapes shown in Figs. 1-6, a three-bar embodiment for a jaw bone shown in Fig. 7, and a two-bar embodiment for a tibia shown in Fig. 8 (see last paragraph on page 10 of the specification), but does not clearly describe an embodiment that has “more than one different shape” in the claimed manner. For examination purposes, this limitation is interpreted as reciting ---wherein the body […] has a geometric structure in accordance with an anatomy of a bone to which an application is made” in order to provide clarity in view of the description noted above.
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 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao (CN 113995488 A) in view of Samchukov (US 2016/0166285 A1). Note that parenthetical citations referring to Zhao are taken from the English translation provided with this Office Action.
Regarding claim 1, Zhao teaches a bone fixation apparatus (shown in Fig. 1), comprising:
a body (defined by arc-shaped rod 31, sliding sleeve 28 and sliding sleeve 32 of mechanism 7, collectively; Figs. 1, 5; para. 0042) has a geometric structure in more than one different shape in accordance with an anatomy of a bone to which an application is made (where the apparatus shown in Fig. 1 is designed for being applied to a fractured limb, at least arc-shaped rod 31 of the body defined above is understood to have a geometric structure for use with the anatomy of said limb; para. 0039),
a rod hole (extending through sliding sleeve 28, identified in Fig. 5, for receiving a guide rod 6 as shown in Fig. 1; para. 0042-0045) on the body, wherein a rod required to construct an outer frame is passed through the rod hole (see rod 6 in Fig. 1),
a rod fixing slot (defined on sliding sleeve 28 for receiving locking screw 29; Fig. 5; para. 0042), wherein the rod fixing slot is in line with the rod hole on a side surface of the body (rod fixing slot for receiving screw 29 is shown to be formed on an outer peripheral surface of sliding sleeve 28 of the body defined above, in line with the rod hole extending through sleeve 28 for receiving rod 6; Figs. 1, 5), and provides fixing the rod by tightening the rod by inserting a first setscrew (as described in para. 0042 and claim 8, rod 6 is fixed within sleeve 28 by tightening first set screw 29; Figs. 1, 5),
a pin hole (extending through sliding sleeve 32 for receiving a pin/K-wire, as shown in Fig. 5; para. 0042, claim 9), wherein the pin hole is located on the side surface of the body, next to the rod fixing slot (pin hole of sliding sleeve 32 is located on the outer peripheral side surface of the sleeve 32 of the body defined above, next to the rod fixing slot defined on the outer peripheral side surface of sliding sleeve 28 for receiving first setscrew 29; Fig. 5), and a pin is passed through the pin hole through the bone of a living thing to which the application is made (a pin passes through the pin hole of the sliding sleeve 32, as shown in Fig. 5, for passing into the limb to which the apparatus of Fig. 1 is applied; para. 0042), and
a pin fixing slot on the body (defined on sliding sleeve 32 for receiving a locking screw 33; Fig. 5; para. 0042), wherein the pin fixing slot is in line with the pin hole, has an internal threaded structure, and provides fixing the pin by tightening the pin by putting a second setscrew (the pin fixing slot threadingly receives second set screw 33 for locking and fixing the pin extending through the pin hole in position; Fig. 5; para. 0042; claim 8).
Zhao does not specifically disclose wherein the body is made of aluminum material.
Samchukov teaches a bone fixation apparatus in the form of an external fixator frame receiving pins (see Figs. 1-3; para. 0026) and discloses wherein components of the apparatus may be made of aluminum.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the body of Zhao’s apparatus of aluminum, as claimed and taught by Samchukov, because Samchukov recognizes that aluminum is a suitable material for constructing such a body that beneficially has radiolucent properties (see Samchukov, para. 0051) and the selection of a material suitable for the intended use requires only routine experimentation in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892, including Ross (US 2010/0305568 A1) and Montross (US 2021/0346060 A1), each of which teach an external fixator frame comprising a body with holes extending through a top surface and holes extending through a side surface.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773