DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 13 June 2024. Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “mechanism to adjust the compressive force post-deployment to accommodate healing dynamics of the bone” as required by claim 10 must be shown or the feature(s) canceled from the claim(s). Furthermore, the “driver specifically adapted to engage with and manipulate the compression screw and the orthopedic staple during surgical instrumentation” as required by claim 19 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Note: Paragraph 0023 of the current specification appears to discuss the claimed “mechanism.” The examiner can find no showing of this in the drawings. Paragraphs 0044 and 0045 of the current specification appears to discuss the claimed “driver.” While Figure 5 appears show a tool/driver, the examiner can find no showing of a driver “adapted to engage with and manipulate the compression screw and the orthopedic staple.”
Specification
The disclosure is objected to because of the following informalities:
Reference numbers 400, 412, 414, 416 and 420 (see Figure 4) are missing from the specification.
It appears that reference number 410 (see paragraphs 0045 and 0046) should be replaced with reference number 510 (see Figure 5), and reference number 410 should be added elsewhere in reference to Figure 4.
Appropriate correction is required.
Claim Objections
Claim 9 is objected to because of the following informality:
In line 2, it appears that the phrase “Active compression devices” should read “active compression devices.”
Claim 11 is objected to because of the following informality:
In line 3, it appears that the phrase “the fracture site” should read “a fracture site.”
Claim 12 is objected to because of the following informality:
In line 3, it appears that the phrase “the fracture site” should read “a fracture site.”
Claim 16 is objected to because of the following informality:
In line 2, it appears that the phrase “the integration of” should read “integration of.”
Claim 18 is objected to because of the following informality:
In line 2, it appears that the phrase “Active compression devices” should read “active compression devices.”
Claim 19 is objected to because of the following informality:
In line 8, it appears that the phrase “the staple configured to” should read “the staple is configured to.”
Claim 20 is objected to because of the following informality:
In line 2, it appears that the phrase “the bridge element” should read “the bridge portion” (see line 2 of claim 19 for antecedent basis).
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a mechanism to adjust the compressive force post-deployment to accommodate healing dynamics of the bone” in claim 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
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.
Claims 19 and 20 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a driver/tool adapted to place the orthopedic staple during surgical implantation (see paragraphs 0045 and 0046 of the current specification), does not reasonably provide enablement for “a driver specifically adapted to engage with and manipulate the compression screw and the orthopedic staple during surgical implantation” (see lines 6 and 7 of claim 19). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The examiner can find nothing in the disclosure indicating exactly how a single driver is used to engage with and manipulate both the compression screw and the orthopedic staple. Since claim 20 is dependent upon claim 19, it contains the same issue.
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.
Claims 10-18 and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 10 recites the limitation “a mechanism to adjust the compressive force post-deployment to accommodate healing dynamics of the bone” in lines 7-8. After a review of the specification (i.e. in view of the interpreted under 35 U.S.C. 112(f) above), it is unclear as to exactly what the “mechanism” is. Paragraph 0023 of the current specification recites a “tensioning mechanism” (not shown in the Figures) that can be adjusted through minimally invasive procedures. Paragraphs 0033 and 0040 of the current specification recite pockets allowing for translation of screws during the healing process. Is the mechanism a “tensioning mechanism” (not shown in the Figures), or a pocket allowing for translation, or something else? Since claims 11-18 are dependent upon claim 10, they contain the same issue.
Claim 20 recites the limitation "the head" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the one or more screws" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the screw head" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the screw head" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Note: It appears that amending lines 1-2 of claim 20 to read “wherein a head of the compression screw is seated” would overcome this rejection. For examination purposes, claim 20 will be treated as such.
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laboureau et al. (U.S. Patent 5,662,655).
Laboureau et al. disclose (as to claim 1) an orthopedic staple (see Figure 4) comprising a bridge portion (2’); a first leg (15) and a second leg (16) extending from opposite ends of the bridge portion, wherein each leg is capable of penetrating and securely anchoring into a bone structure (101/102), wherein the bridge portion comprises a deformable configuration (i.e. configuration as best illustrated in Figure 3c) capable of exerting a compressive force across a fracture site (see Figure 6) in the bone structure when the staple is implanted across the fracture site (see column 6, lines 55-62 and claim 1); and wherein the bridge portion is further capable of enabling dynamic adjustment of the compressive force in response to changes in the bone structure during a healing process (i.e. due to material characteristics of the staple producing an elastic reaction to compress the bone structures on either side of the fracture site, it is the examiner’s position that adjustments to the compressive force will be capable as the healing process takes place), wherein (as to claim 2) the orthopedic staple further comprises a screw (11 or 11’) capable of interacting with (i.e. via 12 or 12’) the bridge portion to apply compressive force across the fracture site (i.e. depending upon the site location, it is the examiner’s position that 12 or 12’ would allow for placement across the site, see Note below regarding functional language), wherein (as to claim 3) the orthopedic staple further comprises a plurality of screws (11 and 11’) capable of interacting with (i.e. via 12 and 12’) the bridge portion, each screw independently adjustable and capable of applying a targeted compressive force across the fracture site (i.e. depending upon the site location, it is the examiner’s position that 12 or 12’ would allow for placement across the site, see Note below regarding functional language), wherein (as to claim 4) a head (i.e. head as best seen in Figure 1A) of the screw is capable of being seated in a variable angle pocket (i.e. pocket as best seen in Figure 4) located in the bridge portion, the pocket capable of securing the screw head without allowing translational movement (see column 5, lines 2-8), and wherein (as to claim 6) the bridge portion is capable of providing active compression post-operatively (see Abstract and claim 1) (see Figures 1-7, and column 4, line 1 – column 6, line 67).
Note: Regarding functional language, "[a]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (see MPEP 2114(II)).
Claims 1 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiner et al. (U.S. Patent 10,420,547).
Weiner et al. disclose (as to claim 1) an orthopedic staple (1210) comprising a bridge portion (1212); a first leg (1214) and a second leg (1214) extending from opposite ends of the bridge portion, wherein each leg is capable of penetrating and securely anchoring into a bone structure, wherein the bridge portion comprises a deformable configuration (i.e. configuration where each instance of 1214 is moved away from one another to create compression) capable of exerting a compressive force across a fracture site in the bone structure when the staple is implanted across the fracture site (see column 5, line 65 – column 6, line 8); and wherein the bridge portion is further capable of enabling dynamic adjustment of the compressive force in response to changes in the bone structure during a healing process (i.e. due to material characteristics of the staple compressing the bone structures on either side of the fracture site, it is the examiner’s position that adjustments to the compressive force will be capable as the healing process takes place) (see column 20, lines 13-20), wherein (as to claim 6) the bridge portion is capable of providing active compression post-operatively (see column 5, line 65 – column 6, line 8), and wherein (as to claim 7) the active compression of the bridge portion is enabled by integration of elastically deformable polygons (see annotated Figure below) into the bridge portion (see annotated Figure below, Figure 18, column 5, line 65 – column 6, line 8, column 10, lines 32-47, and column 20, lines 13-20).
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Claims 1, 6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allen (U.S. Patent 10,064,618).
Allen discloses (as to claim 1) an orthopedic staple (see Figure 3) comprising a bridge portion (302); a first leg (300a) and a second leg (300b) extending from opposite ends of the bridge portion, wherein each leg is capable of penetrating and securely anchoring into a bone structure (e.g. 1150a/1150b), wherein the bridge portion comprises a deformable configuration (i.e. configuration as best illustrated in Figure 11B) capable of exerting a compressive force across a fracture site (e.g. 1152) in the bone structure when the staple is implanted across the fracture site (see column 2, lines 42-45); and wherein the bridge portion is further capable of enabling dynamic adjustment of the compressive force in response to changes in the bone structure during a healing process (i.e. due to material characteristics of the staple compressing the bone structures on either side of the fracture site, it is the examiner’s position that adjustments to the compressive force will be capable as the healing process takes place), wherein (as to claim 6) the bridge portion is capable of providing active compression post-operatively (see column 2, lines 42-45), and wherein (as to claim 8) the active compression of the bridge portion is enabled by a deformable bridge path configured in an "S" shape (see column 7, line 65 – column 8, line 3) (see Figures 3 and 11A-11C, column 7, line 63 – column 9, line 48, and column 17, line 19 – column 20, line 3).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Laboureau et al. (U.S. Patent 5,662,655), as applied to claim 2 above, in view of Coillard-Lavirotte et al. (U.S. Patent Application Publication 2004/0210234).
Laboureau et al. disclose the claimed invention except for wherein a head of the screw is capable of being seated in a pocket within the bridge element, the pocket capable of permitting translational movement of the screw head to accommodate compression and remodeling of the bone structure.
Coillard-Lavirotte et al. teach the use of an implant (1) similar in function to an orthopedic staple, wherein a head of a screw (not shown, see paragraph 0025) is capable of being seated in a pocket (7), the pocket capable of permitting translational movement of the screw head to accommodate compression and remodeling of the bone structure (see Figures 1-4, and paragraphs 0024-0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Laboureau et al. with wherein a head of the screw is capable of being seated in a pocket within the bridge element, the pocket capable of permitting translational movement of the screw head to accommodate compression and remodeling of the bone structure in view of Coillard-Lavirotte et al. in order to provide a well-known, obvious structure allowing for movement of and compression between opposing bone portions to further enable and facilitate osteosynthesis to yield predictable results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Laboureau et al. (U.S. Patent 5,662,655), as applied to claim 1 above, in view of Peterson et al. (U.S. Patent 11,224,467).
Laboureau et al. disclose the claimed invention except for wherein the orthopedic staple further comprises one or more fixation screws configured as active compression devices, enhancing compressive force applied during and after surgical placement.
Peterson et al. teach the use of an active compression fixation screw (14800) capable of enhancing/generating compressive force applied during and after surgical placement (see column 2, line 14 – column 3, line 3), wherein the fixation screw is capable of being used with a staple (see column 3, lines 59-62) (see Figures 148 and 140, column 2, line 14 – column 3, line 3, and column 3, lines 59-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Laboureau et al. with wherein the orthopedic staple further comprises one or more fixation screws configured as active compression devices, enhancing compressive force applied during and after surgical placement in view of Peterson et al. in order to provide an alternative, well-known and obvious screw configuration for actively compressing bone portions/segments to yield predictable results.
Allowable Subject Matter
Claim 10 would be allowable if rewritten or amended to overcome the rejection under 35 U.S.C. 112(b) set forth in this Office action.
Claims 11-18 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10-18 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with the underlined limitations below (i.e. and in view of the interpretation under 35 U.S.C. 112(f) above), an orthopedic staple for use in bone surgery, comprising: a bridge portion; a single leg extending from one end of the bridge portion, wherein the leg is configured to penetrate and securely anchor into bone structure; a compression portion integrated into the bridge portion opposite the single leg, the compression portion configured to apply a targeted compressive force to the bone structure; and the bridge portion including a mechanism to adjust the compressive force post-deployment to accommodate healing dynamics of the bone.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Patterson et al. (U.S. Patent 8,221,478) disclose an orthopedic staple comprising a bridge portion with elastically deformable polygons, and a single leg (see Figure 19A).
Riccione (U.S. Patent Application Publication 2015/0230839) discloses an orthopedic staple comprising a bridge portion with elastically deformable polygons, and a legs.
Taylor et al. (U.S. Patent Application Publication 2021/0378722) disclose an orthopedic staple comprising an elastic bridge portion, and a single leg (see Figure 1).
Fox (U.S. Patent Application Publication 2023/0270435) discloses an orthopedic staple comprising an elastic, s-shaped bridge portion, and legs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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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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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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