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 04 December 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 received on 04 December 2024 are accepted by the examiner.
Claim Objections
Claim 11 is objected to because of the following informalities:
In line 2, it appears that the phrase “the fibula” should read “a fibula.”
In line 4, it appears that the phrase “the tibia” should read “a tibia.”
In line 7, it appears that the phrase “the guide pin” should read “a guide pin.”
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 compression mechanism configured to press the first clamping end toward the second clamping end to grasp the fibula between the first clamping end and the second clamping end” in claim 1.
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 § 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 1-2, 4, 6, 9-13, 15-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campagnoli et al. (U.S. Patent Application Publication 2021/0228221).
Campagnoli et al. disclose (as to claim 1) an apparatus (300) comprising a base (i.e. base defined by 321, 325 and 325); a first arm (i.e. one instance of 55, see Figure 7) extending from the base and comprising a first clamping end (i.e. curved, free end of 55 as best seen in Figure 7) capable of conforming to a fibula (see Note below regarding functional language); a second arm (i.e. the other instance of 55, see Figure 7) extending from the base opposite the first arm, the second arm comprising a second clamping end (i.e. curved, free end of 55 as best seen in Figure 7) capable of conforming to the fibula (see Note below regarding functional language); a compression mechanism (e.g. mechanism provided by spring/memory properties of 55) capable of pressing the first clamping end toward the second clamping end to grasp the fibula between the first clamping end and the second clamping end (see paragraphs 0024, 0037, 0041, 0043 and 0064); and a guide tube (322) between the first arm and the second arm, wherein the guide tube is formed of a radiodense material (e.g. a metal, see paragraphs 0028 and 0037) and is capable of receiving and directing a guide pin for insertion through the fibula and into a tibia (see paragraph 0060 referring to a kit comprising drill pins, and Note below regarding functional language), wherein (as to claim 2) the first arm and the second arm are joined together at the base (see Figure 7), wherein (as to claim 4) the compression mechanism is capable of comprising a radiolucent material (e.g. due to the use of plastics, see paragraph 0028), wherein (as to claim 6) the compression mechanism comprises a spring capable of pressing the first clamping end toward the second clamping end (i.e. spring provided by properties of 55, see paragraphs 0024, 0041, 0043 and 0064), wherein (as to claim 9) the guide tube is formed of a metal (see paragraphs 0028 and 0037), wherein (as to claim 10) the base, the first arm, and/or the second arm are capable of being radiolucent (e.g. due to the use of plastics, see paragraph 0028), wherein (as to claim 11) the apparatus is used in a method comprising placing the apparatus on a fibula (111) in an aligned position such that the guide tube is substantially aligned with an anatomic axis of a distal tibiofibular joint (see paragraphs 0048-0051 referring to the apparatus being centered on bone) that includes the fibula and a tibia (112); engaging the compression mechanism while the apparatus is in the aligned position (i.e. by clipping the apparatus on bone) to press the first clamping end toward the second clamping end to grasp the fibula (see paragraph 0050); and inserting a guide pin (i.e. drill pin) through the guide tube, through the fibula, and into the tibia while the apparatus is in the aligned position (see paragraph 0050), wherein (as to claim 12) the method further comprises repairing a fracture of the fibula (i.e. via use of a plate) prior to placing the apparatus on the fibula (see Figure 10 and paragraph 0051), wherein (as to claim 13) the method further comprises reducing a syndesmosis prior to placing the apparatus on the fibula (i.e. to thereby align the bones in the position as best seen in Figure 10, see paragraph 0050), wherein (as to claim 15) inserting the guide pin comprises drilling the guide pin through the guide tube, through the fibula, and into the tibia such that the guide pin extends distally from the fibula (i.e. to create cavities in 111 and 112 for receiving the implant system as best seen in Figure 10, see paragraph 0050), wherein (as to claim 16) the method further comprises drilling out the guide pin through the fibula and into the tibia to create a first cavity in the fibula and a second cavity in the tibia (i.e. to create cavities in 111 and 112 for receiving the implant system as best seen in Figure 10); and binding the fibula to the tibia using a fixation device (i.e. an Arthrex Syndesmosis TightRope® XP implant system) that is inserted into the first cavity and the second cavity (see paragraph 0050), wherein (as to claim 17) the fixation device comprises a suture (i.e. suture defined by the Arthrex Syndesmosis TightRope® XP implant system, see Figure 10), and wherein (as to claim 19) the method further comprises, prior to drilling out the guide pin, placing a surgical plate (155) on the fibula such that the guide pin extends through a hole in the surgical plate (see paragraph 0051) (see Figure 7, and paragraphs 0024, 0028, 0032, 0037, 0041, 0043, 0048-0049, 0059-0072).
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 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sommers et al. (U.S. Patent 11,751,889).
Sommers et al. disclose (as to claim 1) an apparatus (100) comprising a base (i.e. base defined by 102, 104 and 106); a first arm (406) extending from the base and comprising a first clamping end (i.e. free end defining 418 as best seen in Figure 8) capable of conforming to a fibula (see Note above regarding functional language); a second arm (426) extending from the base opposite the first arm, the second arm comprising a second clamping end (i.e. free end defining 438 as best seen in Figure 8) capable of conforming to the fibula (see Note above regarding functional language); a compression mechanism (i.e. mechanism defined by 416 and 436) capable of pressing the first clamping end toward the second clamping end to grasp the fibula between the first clamping end and the second clamping end (see column 6, lines 16-39); and a guide tube (106) between the first arm and the second arm (location as best seen in Figure 1), wherein the guide tube is formed of a radiodense material (e.g. stainless steel, see column 11, lines 17-33) and is capable of receiving and directing (i.e. via 306) a guide pin for insertion through the fibula and into a tibia (see Note above regarding functional language), wherein (as to claim 5) the compression mechanism is capable of being used to manually adjust a level of compression applied by the first clamping end and the second lamping end to the fibula (i.e. via the interaction between 416 and 436, see column 6, lines 16-39) (see Figures 1-7B, and column 5, line 32 – column 11, line 33).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Campagnoli et al. (U.S. Patent Application Publication 2021/0228221), as applied to claim 1 above, in view of Rush (U.S. Patent 1,985,108).
Campagnoli et al. disclose the claimed invention except for wherein the first clamping end and the second clamping end each have a serrated surface capable of conforming to the fibula.
Rush teaches the use of an apparatus (see Figure 1) comprising a first clamping end (14 and/or 15); and a second clamping end (18), wherein the first clamping end and the second clamping end each have a serrated surface (i.e. surfaces defining 15) (see Figures 1-4, and page 1, column 2, line 44 – page 2, column 1, line 13).
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 Campagnoli et al. with wherein the first clamping end and the second clamping end each have a serrated surface in view of Rush in order to provide a well-known, obvious means for increasing frictional engagement between the clamping ends and bone to yield predictable results.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sommers et al. (U.S. Patent 11,751,889), as applied to claim 1 above, in view of Slocum et al. (U.S. Patent 10,925,655).
Sommers et al. disclose the use of alternative mechanisms for pressing the first clamping end toward the second clamping end (see column 6, lines 34-39); however, fail to explicitly disclose wherein (as to claim 7) the compression mechanism comprises a screw, wherein turning the screw adjusts a level of compression applied to press the first clamping end toward the second clamping end, and wherein (as to claim 8) the compression mechanism comprises an adjustment dial, wherein turning the adjustment dial adjusts a level of compression applied to press the first clamping end toward the second clamping end.
Slocum et al. teach the use of an apparatus (2500) comprising a first clamping end (i.e. free end defined by 102); a second clamping end (i.e. free end defined by 104); and a compression mechanism (i.e. mechanism defined by 2502, 2504 and 2506) capable of pressing the first clamping end toward the second clamping end, wherein the compression mechanism comprises a screw (2504) and an adjustment dial (2506), wherein turning the screw and the adjustment dial adjusts a level of compression applied to press the first clamping end toward the second clamping end (see Figure 25, and column 17, lines 18-28).
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 Sommers et al. with wherein the compression mechanism comprises a screw, wherein turning the screw adjusts a level of compression applied to press the first clamping end toward the second clamping end, and wherein the compression mechanism comprises an adjustment dial, wherein turning the adjustment dial adjusts a level of compression applied to press the first clamping end toward the second clamping end in view of Slocum et al. in order to provide an alternative, well-known and obvious means for providing discrete/fine adjustments of a position of the first clamping end relative to the second clamping end to yield predictable results.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Campagnoli et al. (U.S. Patent Application Publication 2021/0228221), as applied to claim 11 above, in view of Nichols et al. (U.S. Patent Application Publication 2022/0249105).
Campagnoli et al. disclose the claimed method except for wherein the method further comprises using x-ray fluoroscopy to determine that the apparatus is in the aligned position.
Nichols et al. teach the use of fluoroscopy to guide drilling procedures on a fibula and tibia (see paragraphs 0025-0032).
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 method of Campagnoli et al. with wherein the method further comprises using x-ray fluoroscopy to determine that the apparatus is in the aligned position in view of Nichols et al. in order to provide a well-known, obvious means for verifying proper alignments for use during fixation to yield predictable results.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Campagnoli et al. (U.S. Patent Application Publication 2021/0228221), as applied to claim 16 above, in view of Seykora et al. (U.S. Patent 10,201,358).
Campagnoli et al. disclose the claimed method except for wherein (as to claim 18) the fixation device comprises a screw.
Seykora et al. teach a method of binding a fibula to a tibia using a fixation device, wherein the fixation device is capable of being a suture or a screw (see column 1, lines 38-50).
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 method of Campagnoli et al. with wherein the fixation device comprises a screw in view of Seykora et al. in order to provide an alternative, well-known and obvious means for fixing a fibula relative to a tibia to yield predictable results.
Allowable Subject Matter
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter. Claim 20 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 limitations required by claims 1, 11, 15-16 and 19, no prior art reference could be found disclosing or making obvious wherein placing the surgical plate on the fibula comprises placing the surgical plate on the fibula such the guide pin extends through a guide sleeve within the hole in the surgical plate.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kirschman (U.S. Patent 8,998,906) disclose an apparatus comprising a base; a first arm comprising a first clamping end; a second arm comprising a second clamping end; a compression mechanism; and a guide tube between the first arm and the second arm.
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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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775