Notice of Pre-AIA or AIA Status
The present reissue application of US Pat. No. 11,596,458 (“the ‘458 patent”) is being examined under the pre-AIA first to invent provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Reissue Applications
Applicant is reminded of the continuing obligation under 37 CFR § 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which the ‘478 patent is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
Applicant is further reminded of the continuing obligation under 37 CFR § 1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Claim Rejections - 35 USC § 251
Original Patent
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’ ”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360.
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims. Like in Antares, the specification does not set forth an embodiment of an implant for bone fixation that only includes a fastening member without an elongated member and an engagement member as now recited in amended claim 1. Therefore, an implant for bone fixation comprising a fastening member without also an elongated member and an engagement member is not an invention disclosed in the original patent.
Therefore, claims 1-4, 7, 10-14 and 21 which are directed to an implant for bone fixation comprising a fastening member without an elongate member and an engagement member do not satisfy the “original patent” requirement.
Claims 1-4, 7, 10-14 and 21 are rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 20 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 20 recites the limitation "one first side.” Since claim 20 depends from claim 18 it is unclear if the “one first side” is referring to the “a sidewall” in claim 18 or another side.
Claim 20 recites the limitation "a plurality of engagement features.” Since claim 20 depends from claim 18 it is unclear if the “a plurality of engagement features” is referring to the “engagement features” in claim 18 or other engagement features.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-8, 10 and 12-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2016/0199111 to Knoepfle et al (“Knoepfle”) in view of US Pub. No. 2011/0060366 to Heim et al. (“Heim”).
Regarding claims 1 and 21, Knoepfle discloses an implant for bone fixation (see para. [0012]), comprising: a fastening member (16) formed by injection molding (see para. [0060]) that includes an area of material (22) that is easier to cut in order to detach the implant after implantation (see para [0054]).
Knoefle does not disclose a fastening member comprising two separate pieces coupled to one another wherein the at least two separate pieces are coupled to each other by a material formed around the at least two separate pieces, the material having a lower material strength than a material from which one piece of the at least two separate pieces is made such that the material having the lower material strength is easier to cut in order to detach the implant after implantation, and wherein one piece of the at least two separate pieces is partially embedded within the material in that at least part of an upper surface of such piece of the at least two separate pieces is covered by the material and at least part of a lower surface of such piece of the at least two separate pieces is covered by the material.
However, Heim discloses a bone implant, that uses an embedded metal washer plate (50) which serves to both stiffen that portion of the implant and provides a radio-opaque marker, “which is advantageous when tracking the implant [] post-surgery.” See para. [0144]. Additionally, the metal plate of embodiment of Figs. 33-35 is disclosed as a “washer plate” and includes a screw hole (532) through the plate (50) to accommodate a bone screw (530) for attachment to a bone surface. See Fig. 34. As shown in Fig. 33, the washer plate (50) is shaped to contour the outer periphery of the implant.
At the time of filing, it would have been obvious to one skilled in the art to incorporate/embed the washer plate (50) as taught by Heim (embodiment of Figs. 33-35) around each opening (20) and contour the outer periphery of the fastening member (16) of Knoepfle. In other words, one skilled in the art would be motivated to embed a circular washer around the opening (20) and within the material of the fastening member (16) of Knoepfle as taught by the overall washer plate (50) of Heim. Both Knoepfle and Heim teach implants that are fastened to bone with a screw and both teach injection molding of the device. See Knoepfle para. [0015] and Heim para. [0010]. Further, Heim teaches that the washer plate provides the dual advantage of stiffening and providing a radio-opaque marker for tracking post-surgery. Additionally, Knoepfle discloses that the implant may need to be accessed quickly after surgery and the markers of Heim would enhance quick identification of the fastening member and thereby enable faster severing of the device and access to the thoracic region of the patient.
The combination of Knoepfle in view of Heim teaches (see Knoepfle Fig. 2, annotated below) a fastening member (16) that comprises at least two separate pieces (washer plate 50 of Heim) coupled to one another (embedded by injection molding, see Knoepfle para. [0015] and Heim para. [0010]) each piece of the at least two separate pieces comprising an upper surface, a lower surface (see annotated Fig. 2 below) opposite the upper surface and at least one opening (20) extending from the upper surface to the lower surface for receiving a bone fastener (taught by Knoepfle par. [0049] and Heim # 530), wherein the at least two separate pieces are coupled to each other by a material formed around the at least two separate pieces (see annotated Fig. 2 of Knoepfle below), the material (Knoepfle discloses the implant being formed from a polymeric material in a single injection molding process, see para. [0060]) having a lower material strength than a material from which one piece of the at least two separate pieces is made (Heim discloses that the washer plate is made from metal, see para. [0144]) such that the material (polymer) having the lower material strength (than metal) is easier to cut (at 22) in order to detach the implant after implantation (see Knoepfle at paras. [0012], [0051-0052], and [0054]), and wherein one piece of the at least two separate pieces is partially embedded within the material in that at least part of an upper surface of such piece of the at least two separate pieces is covered by the material and at least part of a lower surface of such piece of the at least two separate pieces is covered by the material (see Heim at para. [0158] stating, “[t]he spacer 12 includes a radio-opaque washer plate 50 embedded therein, a screw hole 532 extending therethrough…” (emphasis added) and disclosure of injection molding at para. [0010]; see Knoepfle disclosure of injection molding at para. [0015]).
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Regarding claim 2, Knoepfle in view of Heim teaches the implant of claim 1 and wherein the at least two separate pieces are substantially aligned with a longitudinal axis of the elongated member of the implant when the implant is in a straight, unwound state (see Knoepfle, Fig. 2).
Regarding claim 3, Knoepfle in view of Heim teaches the implant of claim 1 and wherein the at least two separate pieces are plates made from a metallic material (see Heim washer plate 50).
Regarding claim 4, Knoepfle in view of Heim teaches the implant of claim 1 and wherein the material coupling the at least two separated pieces to each other is a polymeric material (Knoepfle discloses the implant being formed from a polymeric material in a single injection molding process, see para. [0060]).
Regarding claim 5, Knoepfle in view of Heim teaches the implant of claim 1 and further an elongated member (Knoepfle # 12) and an engagement member (Knoepfle # 14) both coupled to the fastening member (see Fig. 2 and para. [0015]), the elongated member configured to be wound around bone parts that are to be fixed, and the engagement member being configured to engage a portion of the elongated member so as to secure the elongated member in a loop around the bone parts (Knoepfle para. [0012]).
Regarding claim 6, Knoepfle in view of Heim teaches the implant of claim 5 and wherein the fastening member is coupled to at least one of the elongated member and the engagement member by injection molding (Knoepfle para. [0015]).
Regarding claim 7, Knoepfle in view of Heim teaches the implant of claim 1 and further comprising at least one visual indicator (Knoepfle #22) in a region of lower material strength (Knoepfle discloses polymeric material) between the at least two separate pieces, the visual indicator being defined by a portion of the fastening member that remains exposed from injection molding (Knoepfle para. [0016]).
Regarding claim 8, Knoepfle in view of Heim teaches the implant of claim 5 and wherein the elongated member has a bone-contacting surface (underside of elongated member as shown in Knoepfle Fig. 2) and at least one gripping surface (opposite/top side of the contacting surface) separate from the bone-contacting surface and comprising a plurality of engagement features (24) along a longitudinal extent of the at least one gripping surface, and wherein the engagement member (14) comprises at least one complementary deflectable engagement feature (26) configured to engage at least one of the plurality of engagement features (Knoepfle para. [0063]).
Regarding claim 10, Knoepfle in view of Heim teaches the implant of claim 1 and wherein the at least two separate pieces each include an outer peripheral portion, and a majority of an outer circumference of the outer peripheral portion of each of the at least two separate pieces is embedded within the material having the lower material strength (see annotated Fig. 2 of Knoepfle above).
Regarding claim 12, Knoepfle in view of Heim teaches the implant of claim 1 and wherein each of the at least two separate pieces are entirely in between a bone-contacting surface of the material having the lower material strength and a top surface of the material opposite the bone-contacting surface (see annotated Fig. 2 of Knoepfle above).
Regarding claim 13, Knoepfle in view of Heim teaches the implant of claim 2 and wherein the material having the lower material strength is narrower in width at a first location along the longitudinal axis in between two pieces of the at least two separate pieces than at a second location along the longitudinal axis at one piece of the at least two separate pieces (see annotated Fig. 2 of Knoepfle above, specifically #22).
Regarding claim 14, Knoepfle in view of Heim teaches the implant of claim 1 and wherein the at least two separate pieces each have a round outer perimeter (see annotated Fig. 2 of Knoepfle above).
Regarding claim 15, Knoepfle in view of Heim teaches the implant of claim 5 and wherein the elongated member has a narrower maximum width than the fastening member (see Fig. 2 of Knoepfle).
Regarding claim 16, Knoepfle in view of Heim teaches the implant of claim 5 and wherein the engagement member and the fastening member are arranged within a common plane in a straight, unwound state of the implant (see Fig. 2 of Knoepfle).
Regarding claim 17, Knoepfle in view of Heim teaches the implant of claim 16 and wherein the engagement member comprises at least one deflectable engagement feature (26) that substantially lies within the common plane, and/or that is deflectable within a plane which is parallel or orthogonal to the bone-contacting surface of the implant in a straight, unwound state thereof (see Knoepfle Fig. 3).
Regarding claim 18, the combination of Knoepfle in view of Heim (see entire rejection of claims 1 and 21 above) teaches an implant for bone fixation, comprising: an elongated member (Knoepfle, 12) configured to be wound around bone parts that are to be fixed; an engagement member (Knoepfle, 14) coupled to the elongated member and configured to engage a portion of the elongated member so as to secure the elongated member in a loop around the bone parts; a fastening member (Knoepfle, 16) coupled to the elongated member and the engagement member, wherein the fastening member comprises at least two separate pieces (see entire rejection of claims 1 and 21 above for this claim limitation) coupled to one another each comprising at least one opening for receiving a bone fastener (see entire rejection of claims 1 and 21 above for this claim limitation), wherein the elongated member comprises a lateral step and engagement features (24) of the elongated member are arranged along (abut against, see annotated Fig. 2 below) a sidewall defined by the lateral step, and wherein the engagement member comprises at least one shoulder engaging the lateral step (see annotated Fig. 2 of Knoepfle below).
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Regarding claim 19, Knoepfle in view of Heim teaches the implant of claim 18 and wherein the separate pieces are substantially aligned with a longitudinal axis of the elongated member of the implant when the implant is in a straight, unwound state (see annotated Fig. 2 above).
Regarding claim 20, Knoepfle in view of Heim teaches the implant of claim 18 and wherein the elongated member has a bone-contacting surface (see annotated Fig. 2 above) and at least one first side (see annotated Fig. 2 above) extending substantially perpendicular to the bone-contacting surface and comprising a plurality of engagement features (24) along a longitudinal extent of the at least one first side, and wherein the engagement member (14) comprises at least one complementary deflectable engagement feature (26) configured to engage at least one of the plurality of engagement features (Knoepfle para. [0063]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knoepfle in view of Heim.
Regarding claim 11, Knoepfle in view of Heim teaches the implant of claim 1 as described above but the combination does not explicitly disclose wherein a thickness of each of the at least two separate pieces tapers toward the at least one opening.
However, one skilled in the art at the time of filing would have found it obvious to use a metal washer 50 as taught by Heim with a taper toward the internal opening in order to provide an insert that contours to the outer dimensions and shape of the fastening member and openings of Knoepfle. Heim already teaches that the metal washer contours to the overall shape of the implant. See Heim Fig. 33. Therefore, one skilled in the art would be motivated to taper the opening of the washer of Heim to follow the taper of the opening of the fastening member of Knoepfle in order to provide a washer that fits within the implant (as taught by Heim) and functions as disclosed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/ Reexamination Specialist, Art Unit 3993
Conferees:
/SARAH B MCPARTLIN/ Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/ SPRS, Art Unit 3993
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