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 amendments received after a Non-Final Rejection on 24 October 2025. Claims 1-20 are currently pending.
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, 3, 5 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clyburn (U.S. Patent 5,800,439).
Clyburn discloses (as to claim 1) an orthopaedic instrument (i.e. instrument defined by a conventional bone cement injection gun and 10) capable of being used in a direct anterior approach orthopaedic surgical hip replacement procedure on a patient's femur (see Note 1 below regarding functional language), the orthopaedic instrument comprising a cement nozzle (i.e. nozzle defined by 10 and 36) capable of being inserted in a medullary canal of the patient's femur (see Note 1 below regarding functional language), the cement nozzle comprising a first lumen (12) capable of introducing a bone cement composition (33) into the medullary canal; and a second lumen (18) capable of removing one or more bodily fluids from the medullary canal during introduction of the bone cement composition (i.e. via use of a vacuum source); wherein the first and second lumens are each capable of being curved along (i.e. curvature as best seen in Figure 3) a distal portion (10) of the cement nozzle (i.e. given the semi-rigid nature of the nozzle (see column 3, lines 49-65) and the curved nature of the medullary canal (see Figure 3), it is the examiner’s position that the first and second lumen are capable of being curved along the distal portion), wherein (as to claim 3) the cement nozzle comprises a first cannula (11) defining the first lumen and a second cannula (17) at least partially defining the second lumen, wherein (as to claim 5) the second cannula is disposed around the first cannula along the distal portion of the cement nozzle, such that the second lumen is defined between the first and second cannulas along the distal portion of the cement nozzle (disposition as best seen in Figure 2), and wherein (as to claim 9) the second cannula includes a plurality of fenestrations (23) along the distal portion of the cement nozzle, the plurality of fenestrations capable of permitting the one or more bodily fluids to flow from the medullary canal into the second lumen (see Note below regarding functional language) (see Figures 1-4, and column 3, line 44 – column 5, line 20).
Note 1: 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)).
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dozier, Jr. (U.S. Patent 4,815,454).
Dozier, Jr. discloses an orthopaedic instrument (i.e. instrument defined by 16, 25 and 26) capable of being used in a direct anterior approach orthopaedic surgical hip replacement procedure on a patient's femur (10, see Note 1 above regarding functional language), the orthopaedic instrument comprising a pressurizer (25) capable of sealing a proximal end (e.g. end receiving 25 as best seen in Figure 5) of a medullary canal (12) of the patient's femur when at least partially inserted into (i.e. partial insertion as best seen in Figure 5) the proximal end of the medullary canal after the patient's femur has been proximally resected (i.e. cut, see Note 1 above regarding functional language), wherein the pressurizer is formed to include an upper planar surface (i.e. surface defined by 28 and visible in Figure 6) capable of extending generally parallel to a resected surface (i.e. surface of 10 contacting 28 as best seen in Figure 5) of the femur when the pressurizer is at least partially inserted into the proximal end of the medullary canal (i.e. depending upon the placement of 25, it is the examiner’s position that the surface defined by 28 is fully capable of extending generally parallel to the surface of 10 contacting 28); a lower planar surface (i.e. surface defined by 27 and visible in Figure 4) opposite the upper surface and capable of being inserted into the proximal end of the medullary canal (i.e. insertion as best seen in Figure 5); a sidewall (i.e. sidewall defined by 27 and surrounding/defining 29) connecting the upper planar surface and the lower planar surface, the sidewall comprising a lateral planar section (i.e. lower-most section defined by 27 and shown as a dotted line in Figure 6) and a medial rounded section (i.e. upper-most section defined by 27 and shown as a dotted line in Figure 6) that are capable of conforming to (i.e. after insertion of 26) the proximal end of the medullary canal (see Figure 5 and column 5, lines 57-62); and an interior passageway (29) extending between the upper and lower surfaces and capable of receiving a cement nozzle (22) for adding bone cement composition (15) into the medullary canal while the pressurizer seals the proximal end of the medullary canal, wherein the interior passageway is disposed at an angle (i.e. an approximately perpendicular angle as best seen in Figure 4) relative to the lower surface of (i.e. relative to a plane defined by the lower surface) the pressurizer (see Figures 3-7, and column 4, line 47 – column 7, line 26).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Clyburn (U.S. Patent 5,800,439), as applied to claim 1 above, in view of Tague et al. (U.S. Patent Application Publication 2007/0016216).
Clyburn discloses the claimed invention except for wherein a curvature of the first and second lumens along the distal portion of the cement nozzle is between 30 and 60 degrees.
Tague et al. teach the use of a cement nozzle (152) comprising a lumen (i.e. lumen defined by interior of 152), and set forth that a curvature (i.e. curvature as best seen in Figure 3) of the lumen is a result effective variable, wherein the curvature (i.e. curvature defined by the flexibility of the nozzle) allows movement and improves a line-of-site of a medullary canal when using the nozzle (see Figure 3, and paragraphs 0038-0039).
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 Clyburn with wherein a curvature of the first and second lumens along the distal portion of the cement nozzle is between 30 and 60 degrees in view of Tague et al., for the purpose of allowing movement of the nozzle relative to the instrument and improving the line-of-site of the medullary canal when using the instrument, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Clyburn (U.S. Patent 5,800,439), as applied to claim 3 above, in view of Wilson et al. (U.S. Patent 8,357,168).
Clyburn discloses the claimed invention except for wherein a central axis of the second lumen is spaced apart from a central axis of the first lumen, and wherein the central axis of the second lumen runs parallel to the central axis of the first lumen along the distal portion of the cement nozzle.
Wilson et al. teach the use of a nozzle-like member (210) comprising a first lumen (i.e. lumen defined by 212) capable of introducing a material (see column 10, lines 6-10), and a second lumen (i.e. lumen defined by 214) capable of removing a material (see column 10, lines 12-15), wherein the member comprises a first cannula (212) defining the first lumen and a second cannula (214) defining the second lumen, and wherein a central axis (i.e. axis defined along and through center of 214) of the second lumen is spaced apart from a central axis (i.e. axis defined along and through center of 212) of the first lumen, and wherein the central axis of the second lumen runs parallel to (see Figure 10) the central axis of the first lumen along the member (see Figure 9-10, and column 10, lines 3-36).
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 Clyburn with wherein a central axis of the second lumen is spaced apart from a central axis of the first lumen, and wherein the central axis of the second lumen runs parallel to the central axis of the first lumen along the distal portion of the cement nozzle in view of Wilson et al. in order to provide an alternative, well-known and obvious lumen configuration for introducing and removing material to yield predictable results.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Clyburn (U.S. Patent 5,800,439), as applied to claim 3 above, in view of Reves et al. (U.S. Patent Application Publication 2023/0019406).
Clyburn discloses the claimed invention except for wherein (as to claim 6) a distal end of the first cannula comprises a flared section having different first and second internal diameters, the second internal diameter being larger than and positioned distally of the first internal diameter, wherein (as to claim 7) the second internal diameter is 25 to 75 percent larger than the first internal diameter, and wherein (as to claim 8) the first internal diameter is between 6 and 10 millimeters, and wherein the second internal diameter is between 8 and 16 millimeters.
Reves et al. teach the use of a nozzle-like member (176), wherein a distal end (180) of the member comprises a flared section (i.e. section defined adjacent DD3 as best seen in Figure 18) having different first (e.g. diameter defined at DD3) and second (see annotated Figure below) internal diameters, the second internal diameter being larger than and positioned distally of the first internal diameter (i.e. due to β), wherein the second internal diameter is capable of being 25 to 75 percent larger than the first internal diameter (i.e. due to range defined by β, see paragraph 0098), and wherein the first internal diameter is capable of being between 6 and 10 millimeters (see paragraph 0098), and wherein the second internal diameter is capable of being between 8 and 16 millimeters (i.e. due to range defined by β, see paragraph 0098).
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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 Clyburn with wherein a distal end of the first cannula comprises a flared section having different first and second internal diameters, the second internal diameter being larger than and positioned distally of the first internal diameter, wherein the second internal diameter is 25 to 75 percent larger than the first internal diameter, and wherein the first internal diameter is between 6 and 10 millimeters, and wherein the second internal diameter is between 8 and 16 millimeters in view of Reves et al. in order to provide an alternative, well-known and obvious end configuration for delivering bone cement composition (i.e. a bone material) to yield predictable results.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Clyburn (U.S. Patent 5,800,439), as applied to claim 9 above, in view of Greenhalgh et al. (U.S. Patent 10,888,363).
Clyburn discloses the claimed invention except for wherein (as to claim 10) the plurality of fenestrations are also sized to permit fatty tissue to flow from the medullary canal into the second lumen, and wherein (as to claim 11) a density of the plurality of fenestrations increases in a proximal-to-distal direction along the second cannula.
Greenhalgh et al. teach the use of a device (10) including a plurality of fenestrations (74), wherein the fenestrations are capable of having a different size, shape, density, and gradient (see Figures 4D-4F, and column 21, lines 59-67).
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 Clyburn with wherein the plurality of fenestrations are also sized to permit fatty tissue to flow from the medullary canal into the second lumen, and wherein a density of the plurality of fenestrations increases in a proximal-to-distal direction along the second cannula in view of Greenhalgh et al. in order to provide a well-known, obvious fenestration size/density allowing for a desired material to pass into the lumen to yield predictable results. Furthermore, it has been held that a change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955)), and rearranging parts of an invention (i.e. moving fenestrations to be closer together and/or further apart) involves only routine skill in the art (In re Japikse, 86 USPQ 70).
Claim 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Clyburn (U.S. Patent 5,800,439), as applied to claim 3 above, in view of Chan (U.S. Patent 5,741,265).
Clyburn discloses wherein (as to part of claim 12) the first cannula comprises a notch (i.e. notch defined at diameter transition between 16 and 21/36 as best seen in Figure 4) capable of facilitating separation of the distal portion of the cement nozzle from a proximal portion (36) of the cement nozzle, and wherein (as to claim 13) the first cannula comprises a collar (i.e. collar defined by 21) capable of contacting a pressurizer (26) received on the first cannula after separation of the distal and proximal portions of the cement nozzle (i.e. due to slidable nature of 26 relative to 17, see column 4, lines 34-41).
Clyburn discloses the claimed invention except for wherein (as to the remainder of claim 12) the notch is scored into an outer diameter of the first cannula to provide a narrower wall thickness relative to distal and proximal portions of the first cannula.
Chan teaches the use of a cement nozzle/cannula (5) defining a proximal portion (i.e. portion located between 10 and 45, see Figure 10) separatable from a distal portion (i.e. portion defining 35) by a notch (45), wherein the notch is scored into an outer diameter (i.e. diameter defined by 5) of the nozzle/cannula to provide a narrower wall thickness (i.e. thickness defined by 45) relative to the distal and proximal portions of the cannula (see column 7, lines 53-56) (see Figures 10-13, and column 7, line 46 – column 8, line 12).
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 Clyburn with wherein the notch is scored into an outer diameter of the first cannula to provide a narrower wall thickness relative to distal and proximal portions of the first cannula in view of Chan in order to provide an alternative, well-known and obvious means for easily separating (i.e. by snapping) the proximal portion of the first cannula from the second portion to yield predictable results.
Allowable Subject Matter
Claims 15-17 are 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.
Claims 18-20 are allowed.
Response to Arguments
The applicant’s arguments with respect to claims 1-13, and more specifically the Clyburn reference, have been fully considered but they are not persuasive.
The applicant argues that Clyburn fails to disclose the cement nozzle with “first and second lumens that are each curved along a distal portion of the cement nozzle.” The applicant further argues that lumens that are merely “capable of being curved” are not the same thing as lumens that “are each curved,” as recited in claim 1. The examiner respectfully disagrees.
As stated in the rejection above, given the semi-rigid nature of the nozzle (see column 3, lines 49-65 of Clyburn) and the curved nature of the medullary canal (see Figure 3 of Clyburn), it is the examiner’s position that the first and second lumen are capable of being curved along the distal portion. Furthermore, and as stated above, "[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)). Clyburn discloses wherein the nozzle is capable of being formed of a semi-rigid material. In light of the broadest reasonable interpretations, the term “semi” has been interpreted as half, partially (definition retrieved from https://www.thefreedictionary.com/semi), and the term “rigid” has been interpreted as not flexible or pliant; stiff (https://www.thefreedictionary.com/rigid). Therefore, the term “semi-rigid” has been interpreted as half/partially stiff. Given this, it is the examiner’s position that a degree of flexibility has been afforded such that the nozzle is capable of curving to be inserted into a medullary cavity having a non-straight geometry (see Figure 3 of Clyburn). There is nothing claimed indicating that the curvature is pre-formed/pre-programmed into the nozzle. Furthermore, the applicant’s specification states “it should also be appreciated that the cannulas 20, 22 may be flexible, such that that the curvature of the lumens 24, 26 can change during use of the cement nozzle 10.” The examiner interprets this statement to mean that the curvature is capable of being caused by the flexible nature of the nozzle. The rejection is deemed proper and stands.
The applicant’s arguments with respect to claim 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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