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 .
Response to Arguments
Applicant's arguments filed August 17th, 2026 have been fully considered but they are not persuasive. Applicant’s arguments regarding the 112(f) interpretation of the claims is not found persuasive. Applicant argues that a review of specific portions of their specification provides evidence of sufficient structure to describe their “mechanical actuation mechanism”, “actuation sub-mechanism” in claim 1; “adjustment mechanism” in claim 3; “mechanical actuation mechanism”, “force applying element” in claim 10. The Examiner agrees that upon review of the specification one can find disclosed structures equating to these claimed elements. However, 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 in the claims. One cannot ascertain from the claims alone what a “mechanical actuation mechanism”, “actuation sub-mechanism” in claim 1; “adjustment mechanism” in claim 3; “mechanical actuation mechanism”, “force applying element” in claim 10 are.
The drawing objection is maintained as Applicant has yet to address this issue. Applicant’s arguments traversing the 112(a) new matter rejection do not address the inversely proportional distance relationship between the first and second fixation locations.
Lastly, Applicant argues the prior art fails to teach or disclose newly amended claims 1 and 10. The Examiner respectfully disagrees with this assertion. The moment arm of Hauri (13) moves vertically and rotationally along the range of expansion from a collapsed state to an expanded state and the spring (15) connected to the plates and moment arm provide a substantially constant spring force urging the device to the expanded state. As a result, Applicant’s arguments and remarks are not found persuasive to overcome the prior art and rejections of record.
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 Objections
Claim 13 is objected to because of the following informalities: Claim 13 depends from now canceled claim 12. Appropriate correction is required. For the purpose of examination, claim 13 has been interpreted to depend from claim 10.
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 10-11 and 13-22 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 and 13-22 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.
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.
Claims 3-6 are 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 3 recites the limitation "the first actuation sub-mechanism" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 4-6 are rejected under 35 U.S.C. 112(b) 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 1-7, 10-11, 13-16 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) that is operatively coupled to 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 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), wherein the at least one mechanical actuation mechanism includes a force applying element (see figure below) configured to apply an applied force so as to urge the first place and the second plate away from one another (the applied force is in a vertical direction against both the proximal tibia and distal femur upon which the first and second plates reside), wherein a magnitude of the applied force varies as the device moves along the range of expansion (via the amount of release of hook elements, 41/43), wherein the at least one mechanical actuation mechanism includes a moment arm (13) that varies as the device moves along the range of expansion (about the full range of movement from engaged to released, ¶39), and wherein the varying applied force and the varying moment arm combine to cause the distraction force to be a substantially constant distraction force across the range of expansion (about the full range from engaged to released, (¶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 at least one mechanical actuation 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).
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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) operatively coupled to 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 (¶39), wherein the physical parameter is a moment arm (13) of the applied force about a pivot point (hinge pins 23, 25 form the pivot point), 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, Hauri et al. disclose 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 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.
Conclusion
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 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
