DETAILED ACTION
Response to Amendment
The finality of the last action and the indicated allowability of subject matter is withdrawn in light of the new rejections made in this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7 and 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 7 and 8 are directed to new matter because Applicant’s disclosure, as originally filed, discloses (1) a lateral hook, a medial hook and a transverse hook or (2) a lateral hook, a medial hook and a pedicle screw not and combination of (1) and (2).
For examination, it is assumed that Applicant intended to recite these in the alternative.
Appropriate correction is required.
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 6 and 17 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.
In claims 6 and 17, the recitation “each transverse hook” lacks antecedent basis.
Appropriate correction is required.
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)(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.
Claim(s) 1, 3-10, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ellis et al. (US 8632573).
Regarding claims 1 and 19, Ellis et al. disclose a rib fixation plate that is capable of being used on an immature rib (fractured rib in a child): a plate 360 (Fig. 18); and two rib hooks (318, 320) configured or capable of securing the plate to an immature rib wherein the bone plate is formed of a material with sufficient elasticity for the plate to be flexible, bendable, and/or springy (Figs. 18-26, col. 13, lines 24-34, col. 22, lines 34-67 and col. 23, lines 1-23).
Regarding the recitation “a transverse hook configured to secure the spring plate to a transverse process of a vertebra,” a third hook 312 (for e.g. Fig. 17) which can be secured to a transverse process utilizing wires or sutures or a suitably sized screw (col. 4, lines 35-46, col. 8, lines 27-62, col. 12, lines 44-67 and col. 13, lines 1-22).
Regarding claim 3, Ellis et al. disclose the plate to be made of polyetheretherketone (PEEK), titanium, stainless steel or ultra-high-molecular weight polyethylene (col. 13, lines 35-62).
Regarding claim 4, Ellis et al. disclose the plate adjacent to the apertures in the hook portion to have a thickness greater, less than or the same as the thickness of the plate away from the apertures to either reduce the profile of fasteners placed in the apertures or reinforce the aperture whereby the medial end of the plate can be provided with an increased thickness for the purpose of reinforcing the apertures (col. 6, lines 34-67 and col. 7, lines 1-12).
Regarding claim 5 and 19, Ellis et al. disclose the plate to be secured to be secured to the rib with a bone screw wherein hook 312 is interpreted to be a lateral hook, hook 318 is interpreted to be a medial hook and 318 is interpreted to be a transverse hook. The functional recitation “pedicle” does not impart any special structure to the screw (Figs. 3, 20 and 29, col. 6, lines 13-30, col. 11, lines 36-59).
Regarding claim 6, hook 312 is interpreted to be the lateral hook, hook 320 is interpreted to be the medial hook and hook 318 is interpreted to be the transverse hook (Fig. 17).
Regarding claims 7 and 8, hook 312 is interpreted to be the lateral hook, hook 320 is interpreted to be the medial hook and a screw placed into either or both holes 324 is considered to be a pedicle screw that can penetrate a vertebra based on its angle of placement. The functional recitation “pedicle” does not impart any special structure to the screw (Figs. 3, 20 and 29, col. 6, lines 13-30, col. 11, lines 36-59).
Regarding claim 9, Ellis et al. further disclose providing the plates, fasteners (including screws) and accessories (one or more tools including a screwdriver) in a kit (col. 13, lines 66-67 and col. 14, lines 1-45).
Regarding claims 10 and 20, Ellis et al. disclose the plate to be made of polyetheretherketone (PEEK), titanium, stainless steel or ultra-high-molecular weight polyethylene (col. 13, lines 35-62).
Regarding claim 20, Ellis et al. disclose the plate adjacent to the apertures in the hook portion to have a thickness greater, less than or the same as the thickness of the plate away from the apertures to either reduce the profile of fasteners placed in the apertures or reinforce the aperture whereby the medial end of the plate can be provided with an increased thickness for the purpose of reinforcing the apertures. (col. 6, lines 34-67 and col. 7, lines 1-12). Ellis et al. also disclose the plate to have an angled or bent lateral end wherein movable hooks 318 and 320 are interpreted to be lateral and medial book(Fig. 17).
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(s) 12 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ellis et al. (US 8632573) in view of Mohr et al. (US 7785355).
Regarding claim 12, Ellis et al. disclose all elements of the claimed invention except for a specific reference to the age of the patient (i.e., child or immature). For claims 14 and 15, see previous discussion in this office action for claims 3 and 4.
Regarding claim 16, Ellis et al. disclose the plate to be secured to be secured to the rib with a bone screw wherein hook 318 is interpreted to be a medial hook and hook 320 is interpreted to be a lateral hook (Figs. 3, 17, 20 and 29, col. 6, lines 13-30, col. 11, lines 36-59).
Regarding claim 17, the recitation “each transverse hook configured to secure the spring plate to a transverse process of a vertebra,” a third hook 312 (Fig. 17) is configured to be or can be secured to a transverse process utilizing wires or sutures (col. 4, lines 35-46).
Regarding claim 18, Ellis et al. disclose the plate to be secured to be secured to the rib with a bone screw wherein hook 320 is interpreted to be a medial hook and hook 312 is interpreted to be a lateral hook. The functional recitation “pedicle” does not impart any special structure to the screw and a screw placed into a hole 324 is considered to be a pedicle screw based on its angle of placement (Figs. 3, 20 and 29, col. 6, lines 13-30, col. 11, lines 36-59).
It is well known that bone structures of patients vary in size and location based on the physiological characteristics of a patient such as age. Mohr et al. disclose configuring a plate for children or for different body/frame sizes wherein the plate may have different features such length, width, thickness, number/size/shape of holes (col. 8, lines 38-53).
Therefore, it would have been obvious to one of ordinary skill in the art to have configured the Ellis et al. plate, for use on a child with immature (not fully developed) ribs where one or more ribs is affected, as taught by Mohr et al., for the purpose of fracture fixation or “modulating bone growth.” The claimed method steps are rendered obvious when the plate of the combination of Ellis et al. and Mohr et al. is used for fracture fixation of a rib in a patient who is a child.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ellis et al. (US 8632573) in view of Lin (US 5085660).
Ellis et al. disclose all elements of the claimed invention except for the use of threaded posts and nuts to secure the respective hooks to the plate.
Lin et al. disclose the use of threaded posts and nuts to secure a plate to underlying bone to provide flexibility in the placement of the plate by screwing in the locking pin 20 first and then placing the plate over the locking pin (Fig. 1 and col. 2, lines 13-67 and col. 3).
It would have been obvious to one of ordinary skill in the art to have utilized threaded posts and nuts placed over the threaded posts to secure the Ellis et al. hooks to the plate to provide flexibility in positioning of the plate on the underlying rib.
Response to Arguments
Upon further consideration, new grounds of rejection have been made in this office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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July 31, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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