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 .
Claim Objections
Claim 1 is objected to because of the following informalities: In Line 10, the word --and-- should be added after the comma. Appropriate correction is required.
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 at Line 11-13 recites the newly added limitation “wherein the second shaft hole is disposed through a curved apex of the arcuate surface such that a bone fastener inserted into the second shaft angles the bone fastener towards the proximal end.” which renders the claim indefinite as 1) there is insufficient antecedent basis for the limitation “the second shaft” in Line 12, and 2) it is unclear how the bone fastener can angle the bone fastener towards the proximal end. For purposes of examination, Lines 11-13 are being interpreted as “wherein the second shaft hole is disposed through a curved apex of the arcuate surface such that a bone fastener inserted into the second shaft hole is configured to be angled towards the proximal end.” 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, 2, 5 & 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Medoff et al. (US PG Pub No. 2013/0046349).
Regarding Claim 1 as best understood, Medoff et al. discloses a hook plate (300, Figs. 17A-7E, Paragraphs [140-0142]) comprising: an elongate body portion (301) extending generally along a central longitudinal axis (axis running centrally through entire length of 301 between 302 & 303, Fig. 17D); a top surface (uppermost external surface of 300, Fig. 1) extending between a proximal end (303, Fig. 17A) and a distal end (302, Fig. 17A); wherein the hook plate is symmetrical about a plane extending through the central longitudinal axis perpendicular to the top surface (vertical plane running centrally through 301 along length of 301) (Figs. 17D-17E); a first shaft hole (right-most circular aperture 315 at end 303, Fig. 17D) located at the proximal end and a second shaft hole (left-most partially circular aperture formed between 304 & 305 at end 302, Figs. 17D-17E) located at the distal end; and an arcuate surface (See examiner annotated Figs. 17A & 17C below) located at the distal end and extending away from a plane of the elongate body portion (horizontal plane running along the uppermost external surface of 300 along length of 301, Fig. 17C), wherein the arcuate surface is capable of capturing a distal bone fragment of a tibia or a fibula (See Figs. 19-21 for example), and wherein the second shaft hole is disposed through a curved apex of the arcuate surface (curved apex 311, See Fig. 17C below) such that a bone fastener inserted into the second shaft hole is capable of being angled towards the proximal end. (Paragraph [0140], See Figs. 19-21 for example. The plate 300 is fully and structurally capable of being used on a tibia or fibula, and a bone fastener inserted into the second shaft hole is fully and structurally capable of being angled toward the proximal end of the plate as recited in the functional language of the claim.).
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Regarding Claim 2, Medoff et al. discloses wherein the top surface is generally planar (linear region 301, Figs. 17A, 17C, Paragraphs [0141-0142]).
Regarding Claim 5, Medoff et al. discloses wherein each of the first shaft hole and the second shaft hole are capable of receiving either a locking screw or a non-locking screw (bone screw, “Moreover, and as best seen in FIG. 17A, slotted hole 316 and each circular hole 315 includes an associated countersunk, beveled perimeter, relative to the top surface of elongated body 301, facilitating the frusto-conical heads of conventional bone screws to be fully seated against, and hence in securing engagement with, an associated hole upon implantation. The countersunk, beveled perimeter of these apertures further serve to direct each associated bone screw into a desired orientation, typically substantially perpendicular to the adjacent portion of the contoured surface of elongated body 301.”, Paragraph [0140]. The holes are fully and structurally capable of receiving locking or non-locking screws as recited in the functional language of the claim.).
Regarding Claim 8, Medoff et al. discloses wherein a distal-most end of the arcuate surface comprises a hook assembly comprising two separate hooks (304 & 305, Figs. 17A-17C & 17E, Paragraph [0142]).
Regarding Claim 9, Medoff et al. discloses wherein each hook comprises a flat surface (lateral edges of 304 & 305 are flat as seen in Figs. 17A-17C), and each flat surface comprises cutting edge (each cutting edge is defined at the respective tip of 304 & 305) (“For all of the above-described variations of hook plates of the present invention contoured for application to fractures of the distal radius, the first and second toothed members, which are substantially triangular in cross-section, are each preferably sharpened at the tip and along at least one of the vertical edges to create sharp cutting surface”, Paragraph [0147]).
Regarding Claim 10, Medoff et al. discloses wherein each cutting edge extends along a single line that is perpendicularly skew to the central longitudinal axis (See examiner annotated Fig. 17E below).
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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) 3, 4 & 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medoff et al. (US PG Pub No. 2013/0046349).
Regarding Claims 3-4, Medoff et al. discloses the claimed invention as stated above in claim 1, and further discloses wherein the elongate body portion comprises a plurality of additional shaft holes comprising a circular hole (second 315 from the left, Fig. 17D) and an elongate slot (slotted hole 316, Figs. 17D-E, Paragraph [0140]) for a securing member (bone screw) allowing for a range of securing member insertion locations (Paragraphs [0115, 0140]), wherein the elongate slot comprises a rib (countersunk, beveled perimeter, Fig. 17A & 17D) extending around an inner perimeter of the elongate slot below the top surface of the hook plate (“slotted hole 316 and each circular hole 315 includes an associated countersunk, beveled perimeter, relative to the top surface of elongated body 301, facilitating the frusto-conical heads of conventional bone screws to be fully seated against, and hence in securing engagement with, an associated hole upon implantation.”).
Medoff et al. does not disclose that the elongate body portion comprises a plurality of elongate slots. However, in Paragraph [0115], Medoff et al. discloses “Although both a six-hole left bone plate and a ten-hole right bone plate have been described above, other configurations of the present invention are also contemplated, including both left and right variations of bone plates, ranging in size from a four-hole bone plate, having an overall length of approximately 2.264 inches, to a twelve-hole bone plate, having an overall length of approximately 5.335 inches, or longer plates with more holes. Moreover, although, in preferred embodiments, each bone plate includes one slotted or oval hole for use in cooperation with bone screws, with the remaining holes being circular, other combinations of slotted and round bone screw accepting holes may alternatively be used. Alternatively, the hooks may be of identical length.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the elongate body of the plate of Medoff et al. to be a six-hole bone plate comprising an additional circular hole and elongate slot located between the proximal and distal ends of the elongate body as taught by Medoff et al. as an alternate and functionally equivalent hole arrangement which allows stabilization and fixation of bone fractures as needed based on a patient’s particular anatomy and needs and the surgeon’s preference during the procedure.
Regarding Claim 6, Medoff et al. discloses the claimed invention as stated above in claim 1, and further discloses wherein the arcuate surface extends in an arc (213, Fig. 17C) having an angle (314, Fig. 17C) from the elongate body (Paragraph [0142]).
Medoff et al. does not disclose that the angle is 135-150 degrees. Paragraph [0142] discloses that the “first toothed member 304 and second toothed member 305 are each disposed at an angle 314, relative to a longitudinal axis of flared region 307, at an angle of approximately 75 degrees. Although, in a preferred embodiment, these two bend angles are achieved through curvature of portions of hook plate 300, sharper bends, rather than more gentle curves, may alternatively be used.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the arc angle of the arcuate surface of the plate of Medoff et al. to be 135-150 degrees since it has been held that 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. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s amendments, filed 06/02/26, have overcome the 112(b) rejection for Claim 7.
In regards to Applicant’s arguments, filed 06/02/26, with respect the Medoff rejection of Claims 1, 2, 5 & 7-10, the newly added language of Claim 1, and the Applicant’s contention that “This hole, however, does not disclose that "the second shaft hole is disposed through a curved apex of the arcuate surface such that a bone fastener inserted into the second shaft angles the bone fastener towards the proximal end," as this hole receives a bone fastener that is not configured to angle the bone fastener towards the proximal end.”: As stated in the office action above, Medoff et al. discloses the hook plate of claim 1, specifically an arcuate surface as seen in the examiner annotated Figs. 17A & 17C above which is located at the distal end and extending away from a plane of the elongate body portion (horizontal plane running along the uppermost external surface of 300 along length of 301, Fig. 17C), wherein the arcuate surface is capable of capturing a distal bone fragment of a tibia or a fibula (See Figs. 19-21 for example), and wherein the second shaft hole is disposed through a curved apex of the arcuate surface (curved apex 311, See Fig. 17C below) such that a bone fastener inserted into the second shaft hole is capable of being angled towards the proximal end. (Paragraph [0140], See Figs. 19-21 for example.) The plate 300 of Medoff et al. is fully and structurally capable of being used on a tibia or fibula, and a bone fastener inserted into the second shaft hole is fully and structurally capable of being angled toward the proximal end of the plate as recited in the functional language of the claim. Thus, Medoff et al. discloses the claimed invention and the argument as presented by the Applicant has been fully considered but is not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. 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.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
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