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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 2nd, 2026 has been entered.
Response to Arguments
Applicant's arguments filed January 2nd, 2026 have been fully considered but they are not persuasive. Applicant’s arguments and remarks are not found persuasive to overcome the prior art and rejections of record. A more detailed explanation can be found below in the body of the rejection.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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.
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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: “mechanical actuation mechanism”, “actuation sub-mechanism” in claim 1; “adjustment mechanism” in claim 3; “mechanical actuation mechanism”, “force applying element” in claim 10. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (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) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 10-22 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. Regarding claim 10, Applicant now recites “wherein a magnitude of the applied force varies as the distraction device moves along a range of expansion and in a manner that is inversely proportional to a distance between the first fixation location and the second fixation location”. Applicant’s disclosure fails to provide support for the inversely proportional distance relationship between the first and second fixation locations.
Claims 11-22 are rejected under 35 U.S.C. 112(a) as they depend from a rejected base claim and do not rectify the issue at hand.
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 1-16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hauri et al. (US 2009/0222089).
Regarding claim 1, Hauri et al. disclose a device, comprising a first plate (7 + 9) configured to interface with a first bone structure of a joint; a second plate (5) configured to interface with a second bone structure of the joint opposite the first bone structure; and at least one mechanical actuation mechanism (13 + 15 + 41 + 43) disposed between the first plate and the second plate and configured to apply a distraction force along an axis between the first plate and the second plate so as to urge the first plate and the second plate away from one another (¶39), wherein the at least one mechanical actuation mechanism comprises a first actuation sub-mechanism (see figure below), wherein the first actuation sub-mechanism is configured to provide a first actuation sub-mechanism distraction force between the first plate and the second plate (the distraction force is applied in a vertical direction against both the proximal tibia and distal femur upon which the first and second plates reside) and a second actuation sub-mechanism (see figure below), wherein the second actuation sub-mechanism is configured to provide a second actuation sub-mechanism distraction force between the first plate and the second plate wherein the second actuation sub-mechanism applies the second sub-mechanism distraction force to the first plate and the second plate that are a same first plate and a same second plate as the first actuation sub-mechanism (the distraction force is applied in a vertical direction against both the proximal tibia and distal femur upon which the first and second plates reside), wherein the second actuation sub-mechanism distraction force is antagonist to the first actuation sub-mechanism distraction force (¶39-41, each force applies an upward force to the respective condyle which yields a downward tilting force toward the other plate/actuation sub-mechanism); wherein the device is configured so as to have a range of expansion ranging from a minimum distance between the first plate and the second plate to a maximum distance between the first plate and the second plate (¶39-41), and wherein the first actuation sub-mechanism distraction force and the second actuation sub-mechanism distraction force are antagonist to one another such that they vary in generally opposing manners across the range of expansion (as the first distraction force applies an “upward” force to the “left” condyles of the femur and tibia it applies an opposite “downward” force to the “right” and left condyles of the femur and tibia” and vice versa with respect to the second distraction force), wherein the first actuation sub-mechanism distraction force and the second actuation sub-mechanism distraction force combine to provide the distraction force that is a sum of the first actuation sub-mechanism distraction force and the second actuation sub-mechanism distraction force (the combined application of forces to the separate bearing plates (aka the sum) is required to balance and separate the bearing plates and place the knee joint under proper alignment/loading) and is a substantially constant distraction force across the range of expansion (¶39).
Regarding claim 2, Hauri et al. disclose the device is configured so as to allow the substantially constant distraction force to be adjusted (¶39-40 by modifying/swapping spring 15 out for spring 15’).
Regarding claim 3, Hauri et al. disclose the first actuation sub-mechanism comprises an adjustment element (41/43) that is one of adjustable or interchangeable to thereby adjust the substantially constant distraction force.
Regarding claim 4, Hauri et al. disclose the adjustment element comprises a spring (15/15’) having an adjustable preload. Regarding claim 5, Hauri et al. disclose the adjustment element comprises an interchangeable cartridge (15 can be interchanged for 15’).
Regarding claim 6, Hauri et al. disclose the adjustment element comprises an interchangeable spring (15/15’).
Regarding claim 7, Hauri et al. disclose the device is configured so as to allow the substantially constant distraction force to be adjusted while positioned in situ (¶39).
Regarding claim 8, Hauri et al. disclose the device is configured to apply the substantially constant distraction force to a single condyle of a bicondylar joint (figures 1, 2). Regarding claim 9, Hauri et al. disclose the device is configured to be joined to a further one of the devices so as to apply the substantially constant distraction force to both condyles of a bicondylar joint (¶39).
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Regarding claim 10, Hauri et al. disclose a kit, comprising a distraction device (1, figure 1), comprising a first fixation location (9a) configured to receive a first bone contacting element (9b) so as to position the first bone contacting element so as to be configured to interface with a first bone structure of a joint (¶41); a second fixation location (7a) configured to receive a second bone contacting element (7b) so as to position the second bone contacting element so as to be configured to interface with a second bone structure of the joint opposite the first bone structure (¶41); and a mechanical actuation mechanism (13 + 15 + 41 + 43) disposed between the first fixation location and the second fixation location and configured to apply a distraction force along an axis between the first fixation location and the second fixation location so as to urge the first bone contacting element and the second bone contacting element away from one another (¶39), wherein the mechanical actuation mechanism includes a force applying element (15/15’) configured to apply an applied force so as to urge the first bone contacting element and the second bone contacting element away from one another, wherein a magnitude of the applied force varies as the distraction device moves along a range of expansion (via the amount of release of hook elements, 41/43) and in a manner that is inversely proportional to a distance between the first fixation location and the second fixation location (in as much as Applicant’s as the force applied will increase as the distance decreases as it requires more force to displace the joint space), wherein the mechanical actuation mechanism includes a physical parameter that varies as the distraction device moves along the range of expansion and wherein the distraction force varies based on the varying applied force and the varying physical parameter combine to cause the distraction force to be a substantially constant distraction force across the range of expansion (¶39); and a plurality of bone contacting elements (7b, 9b), wherein the first bone contacting element and the second bone contacting element are selected from among the plurality of bone contacting elements. Regarding claim 11, wherein the device is configured so as to allow the substantially constant distraction force to be adjusted (open/closed via hook elements 41/43).
Regarding claim 12, Hauri et al. disclose wherein the varying physical parameter is a varying moment arm (13). Regarding claim 13, Hauri et al. disclose wherein the device comprises an adjustment dial (41/43) that is adjustable so as to adjust the varying moment arm.
Regarding claim 14, Hauri et al. disclose the adjustment dial is adjustable to a plurality of discrete settings (about the full range from engaged to released, ¶39).
Regarding claim 15, Hauri et al. disclose the distraction device is configured such that, when in use, the first bone contacting element and the second bone contacting element are positioned in an intraarticular position and the mechanical actuation mechanism is positioned in an extraarticular position (figure 6a-6d).
Regarding claim 16, Hauri et al. disclose at least one of the plurality of bone contacting elements comprises a trial (¶41).
Regarding claim 18, Hauri et al. disclose at least one of the plurality of bone contacting elements is configured to be secured to bone (via frictional engagement between surfaces). Regarding claim 19, Hauri et al. disclose at least one of the plurality of bone contacting elements comprises a textured surface (figures 1-2, a flat, smooth textured surface). Regarding claim 20, Hauri et al. disclose the first fixation location is configured to allow the first bone contacting element to rotate with respect to the first fixation location about an axis that is perpendicular to an axis of expansion of the distraction device (first fixation location can rotate about pins 31a, 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.
Claims 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hauri et al. (US 2009/0222089) in view of Pierce et al. (US 2010/0250571.
Regarding claim 17, Hauri et al. disclose the claimed invention except for at least one of the plurality of bone contacting elements comprises a tracker
Pierce et al. disclose at least one of the plurality of bone contacting elements comprises a tracker (116). Wherein the tracker provides a readout of the gap between the first and second plates (¶44).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the kit of Hauri et al. to include a tracker as taught by Pierce et al. as the tracker provides a readout of the gap between the first and second plates.
Regarding claim 21, Hauri et al. disclose the claimed invention except for the distraction device comprises a scale and a pointer, and wherein the distraction device is configured such that the pointer indicates a current gap between the first bone contacting element and the second bone contacting element on the scale.
Pierce et al. disclose the distraction device comprises a scale (116) and a pointer (see figure below), and wherein the distraction device is configured such that the pointer indicates a current gap between the first bone contacting element and the second bone contacting element on the scale (¶44).
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Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the kit of Hauri et al. to include a scale and a pointer, and wherein the distraction device is configured such that the pointer indicates a current gap between the first bone contacting element and the second bone contacting element on the scale as taught by Pierce et al. as it provides the operator a clear readout of the current level of distraction between the first and second plates.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hauri et al. (US 2009/0222089) in view of Pierce et al. (US 2010/0250571) in further view of Yang (US 6,989,495).
Regarding claim 22, Hauri et al. in view of Pierce et al. disclose the claimed invention except for the distraction device comprises a marker slidably positioned on the scale, and wherein the pointer is configured to slide the marker along the scale such that the marker indicates one of a maximum gap between the first bone contacting element and the second bone contacting element or a minimum gap between the first bone contacting element and the second bone contacting element. Yang discloses a device comprising a marker (18) slidably positioned on a scale (17), and wherein the pointer is configured to slide the marker along the scale such that the marker indicates one of a maximum gap between a first element and a second contacting element (column 4, lines 44-53) to indicate the maximum displacement between the first and second contacting elements.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the distraction device comprises a marker slidably positioned on the scale, and wherein the pointer is configured to slide the marker along the scale such that the marker indicates one of a maximum gap between the first bone contacting element and the second bone contacting element as taught by Yang as it provides an indicator of the maximum displacement between the first and second contacting elements.
Allowable Subject Matter
Claim 23 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619