DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/5/2026 has been entered.
Priority
It is noted that the claims have support going back to US Provisional Application 61/240071 filed 9/4/2009. As such, the claims have an effective filing date of 9/4/2009.
Response to Arguments
Applicant’s arguments with respect to claim(s) below 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. The prior art was reinterpreted in view of applicant’s amendment. It is noted that the limitation of placement on a long bone is intended use and the claims are directed to a device and not a method of use. The device of Pool is capable of being placed on a long bone. In an effort to expedite prosecution, Pool further teaches that the distraction device is applicable in different areas/bone of the bone, including on long bones (see Fig 53, paragraph 129, 185 and rejections below).
Claim Objections
Claims 1-20 objected to because of the following informalities:
There is a discrepancy between the preambles of claim 1 and 18 and the body of the claims 1 and 18 and it is suggested to stay consistent with claim terminology to avoid confusion. As such it is suggested to recite Claims 1 and 18 as follows:
“A lengthening device configured for placement between a first bone section of a long bone and a second bone section of the long bone, the device comprising: a distraction shaft configured for fixation to the [[a]] first bone section of [[a]] the long bone; a housing configured for fixation to the[[a]] second bone section of the long bone,”
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,944,358 (hereinafter ‘358) in view of Pool US 2009/0112263, as evidenced by Pruyn US 1,340,250.
Regarding Claim 1, ‘358 discloses a lengthening device configured for placement between a first bone section and a second bone section (claim 1 preamble), the device comprising:
a distraction shaft configured for fixation to a first bone section of a long bone (claim 1, col 14 line 15-16, where the device is capable of being placed on a long bone);
a housing configured for fixation to a second bone section of a long bone, wherein the distraction shaft is disposed at least partially within the housing (claim 1, col 14 line18-20 where the device is capable of being placed on a long bone);
an actuator configured to increase at least one of a distraction force between the distraction shaft and the housing or a length of the lengthening device (claim 1, col 14 line 35-39).
’358 also discloses the limitations of Claims 2-9 (see claims 2-9 respectively), Claim 10 (see claim 1 col 14 line 23-25), Claim 11 (col 14 lines 22-31, claim 10), Claims 12-17 (see claims 11-16, respectively).
‘358 also discloses a magnet coupled to a gear assembly (claim 1, col 13 lines 41-42) but does not disclose the actuator including a thrust bearing disposed about a portion of the gear assembly.
Regarding Claim 1, Pool discloses a lengthening device (Fig 6c) configured for placement between a first bone section and a second bone section, the device comprising:
a distraction shaft (#146) configured for fixation to the first bone section (able be fixed using a clamp or use of screws and connectors, Fig 4);
a housing (#150) configured for fixation to the second bone section (able to be fixed using a clamp or use of screws and connectors, Fig 4), wherein the distraction shaft is disposed at least partially within the housing (Fig 6c, paragraph 77, 89); and
an actuator (#218, #226) configured to increase at least one of a distraction force between the distraction shaft and the housing and a length of the lengthening device (paragraph 90)
the actuator including a thrust bearing (“A second ball optional bearing [not shown] can be included on the opposite end of the magnetic element 218” end of paragraph 88)(it is noted that ball bearing are known in the mechanical art as being ring shaped with a center through opening, as evidenced by Pruyn, Fig 1 which shows a typical ball bearing with a center through opening #3) disposed about a portion (shaft of a gear assembly, see Fig below) of a gear assembly (see Fig 6g below the opposite end of the magnet has a shaft of a gear assembly extending therefrom and as discussed at the end of paragraph 88, the ball/thrust bearing would be placed on the opposite end of magnet #218 and about the about the lower end of the shaft of the gear assembly, where the shaft would extend through the through opening of the thrust/ball bearing).
PNG
media_image1.png
612
839
media_image1.png
Greyscale
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify ‘358 to include to have the gear assembly coupled to the magnet via a shaft, a thrust bearing positioned about the shaft in view of Pool above because this provides a known way for the magnet and gear assembly to be connected and where the thrust bearing reduces rotational friction.
Claims 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-19 of U.S. Patent No. 11,944,358 (hereinafter ‘358) in view of Pool US 2009/0112263.
‘358 discloses the limitations of Claim 18 (see claim 17 but claim 17 in ‘358 recites additional features related to the lip seal and lip seal flange, claim 1 Col 16 lines 3-12). ‘358 also discloses the limitation of Claim 19 (see Claim 18), and Claim 20 (claim 17, col 16 lines 3-12, claim 19).
‘358 also discloses a magnet coupled to a gear assembly (claim 17, col 16 lines 35-36) but does not disclose the actuator including a thrust bearing disposed about a portion of the gear assembly.
Pool discloses a lengthening device (Fig 6c) configured for placement between a first bone section and a second bone section, the device comprising:
a distraction shaft (#146), wherein the distraction shaft is configured for fixation to the first bone section (able be fixed using a clamp or use of screws and connectors, Fig 4);
a housing (#150) configured for fixation to the second bone section (able to be fixed using a clamp or use of screws and connectors, Fig 4), wherein the distraction shaft is disposed partially within the housing (Fig 6c, paragraph 77, 89); and
an actuator (#218, #226) configured to increase at least one of a distraction force between the distraction shaft and the housing and a length of the lengthening device (paragraph 90), the actuator including:
a permanent magnet (#218) being configured for rotation relative to the housing (paragraph 90); and
a lead screw (#226) operatively coupled to the permanent magnet via a gear assembly (#240, #238, Fig 6d-6g),
the actuator including a thrust bearing (“A second ball optional bearing [not shown] can be included on the opposite end of the magnetic element 218” end of paragraph 88)(it is noted that ball bearing are known in the mechanical art as being ring shaped with a center through opening, as evidenced by Pruyn, Fig 1 which shows a typical ball bearing with a center through opening #3) disposed about a portion (shaft of a gear assembly, see Fig below) of a gear assembly (see Fig 6g below the opposite end of the magnet has a shaft of a gear assembly extending therefrom and as discussed at the end of paragraph 88, the ball/thrust bearing would be placed on the opposite end of magnet #218 and about the about the lower end of the shaft of the gear assembly, where the shaft would extend through the through opening of the thrust/ball bearing).
PNG
media_image1.png
612
839
media_image1.png
Greyscale
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify ‘358 to include to have the gear assembly coupled to the magnet via a shaft, a thrust bearing positioned about the shaft in view of Pool above because this provides a known way for the magnet and gear assembly to be connected and where the thrust bearing reduces rotational friction.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is rejected under pre-AIA 35 U.S.C. 102 (a) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Pool US 2009/0112263 and evidenced by Pruyn US 1,340,250.
Regarding Claim 1, Pool discloses a lengthening device (Fig 6c) configured for placement between a first bone section and a second bone section, the device comprising:
a distraction shaft (#146) configured for fixation to a first bone section of a long bone (able be fixed using a clamp or use of screws and connectors, Fig 4, where this limitation is intended use and the shaft is able to be placed on a long bone);
a housing (#150) configured for fixation to a second bone section of the long bone (able to be fixed using a clamp or use of screws and connectors, Fig 4 where this limitation is intended use and the housing is able to be placed on a long bone), wherein the distraction shaft is disposed at least partially within the housing (Fig 6c, paragraph 77, 89); and
an actuator (#218, #226) configured to increase at least one of a distraction force between the distraction shaft and the housing or a length of the lengthening device (paragraph 90)
the actuator including a thrust bearing (“A second ball optional bearing [not shown] can be included on the opposite end of the magnetic element 218” end of paragraph 88)(it is noted that ball bearing are known in the mechanical art as being ring shaped with a center through opening, as evidenced by Pruyn, Fig 1 which shows a typical ball bearing with a center through opening #3) disposed about a portion (shaft of a gear assembly, see Fig below) of a gear assembly (see Fig 6g below the opposite end of the magnet has a shaft of a gear assembly extending therefrom and as discussed at the end of paragraph 88, the ball/thrust bearing would be placed on the opposite end of magnet #218 and about the about the lower end of the shaft of the gear assembly, where the shaft would extend through the through opening of the thrust/ball bearing).
PNG
media_image1.png
612
839
media_image1.png
Greyscale
In the alternative, Pool does not disclose explicitly disclose the distraction shaft configured for fixation to a first bone section of a long bone, the housing configured for fixation to a second bone section of the long bone.
Pool discloses the distraction device can be used in other applications/bone such as long bones (paragraph 185, see also Fig 53, paragraph 129).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the device of Pool to be sized to be used on long bone in view of additional teachings of Pool because this provides known alternate use for the distraction device on other bones.
Claim 2-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pool US 2009/0112263, as evidenced by Pruyn US 1,340,250, in view of Schwarzler US 6,918,838.
Pool discloses the claimed invention as discussed above, including a a collar (“overlapping region” of the housing #150, second sentence of paragraph 77) configured to allow sliding of the distraction shaft within the housing (paragraph 77, 89), but does not disclose the distraction shaft comprises an axial groove disposed on an outer surface thereof.
Schwarzler, pertinent to the problem of low friction telescoping movement as well as prevention of rotation, discloses a distraction shaft (#31) having an internal cavity (as seen in Fig 1, 8), a housing (#21), wherein the distraction shaft is configured to be telescopingly displaceable relative to and disposed partially within the housing (Fig 1, Col 1 lines 30-40), balls (#41) received in axial grooves (#32) of the shaft and axial grooves (#22) of the housing, where the grooves of the housing provides for the housing to be splined (Fig 1), a ball cage (#42) which helps fixes the balls in place (claim 1), a collar (portion of housing #21 that overlaps with the shaft #31, where this region contains the axial grooves #32, #22 and balls #41, Fig 1) configured to allow sliding of the distraction shaft within the housing (Col 1 lines 30-40) and to prevent the distraction shaft from rotating within the housing (Fig 1, by virtue of the balls within the axial grooves of the housing and shaft), where this configuration provides for low friction sliding of the shaft (Col 1 lines 30-43).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Schwarzler to include balls, the housing and shaft each include grooves to receive the balls and a ball cage to fix the balls in place in view of Schwarzler because this allows for low friction sliding of the shaft relative to the housing and prevent rotation.
Regarding Claim 3, Pool as modified discloses wherein the distraction shaft further comprises a plurality of axial grooves (#32 as taught by Schwarzler above, Col 3 lines 60-67 in Schwarzler) disposed on an outer surface thereof (Fig 8 in Schwarzler).
Regarding Claim 4, Pool as modified discloses the axial groove (#32 as taught by Schwarzler above) comprises an indentation having a semi-circular cross-sectional shape (Fig 8 in Schwarzler).
Regarding Claim 5, Pool as modified discloses a ball (#41 as taught by Schwarzler above) disposed within the axial groove (Col 3 lines 60-67 in Schwarzler).
Regarding Claim 6, Pool as modified discloses a ball cage (#42 as taught by Schwarzler above) disposed over the distraction shaft and the ball, the ball cage being configured to trap the ball (claim 1 in Schwarzler).
Regarding Claim 7, Pool as modified discloses a collar (with the modification, the housing is provided with a splined configuration which would define the collar that allows for sliding and prevent rotation), the collar further comprises a splined housing (as discussed above in claim 2 with the modification in view of Schwarzler) disposed over the ball and the ball cage (Fig 1 in Schwarzler), the splined housing having an axial groove (#22 in Schwarzler, as taught above in claim 2) disposed along an inner diameter surface of the splined housing (Fig 1, 4 in Schwarzler), wherein the axial groove disposed along the inner diameter surface of the splined housing corresponds to the axial groove disposed on the outer surface of the distraction shaft (Fig 1 in Schwarzler, Col 3 lines 60-67 in Schwarzler), and wherein the ball and the ball cage are interposed between the distraction shaft and the splined housing (Fig 1 in Schwarzler).
Regarding Claim 8, Pool as modified discloses the ball is constrained by the ball cage, and is configured to rotationally lock the axial groove disposed along the inner diameter surface of the splined housing to the axial groove disposed on the outer surface of the distraction shaft (claim 1 in Schwarzler, abstract).
Regarding Claim 9, Pool as modified discloses the ball is configured to roll within the linear cage and partially within each of the axial groove of the splined housing and the axial groove disposed on the distraction shaft, thereby allowing axial displacement of the distraction shaft relative to the splined housing (Fig 1 in Schwarzler, Col 1 lines 30-45).
Regarding Claim 10, Pool as modified discloses a seal (#216 in Pool, paragraph 88 in Pool) but does not disclose a sliding seal disposed between the distraction shaft and the splined housing.
Schwarzler further discloses the shaft (#31) extending from a tapered area (#25, #26, Fig 1) of the housing, the tapered area accommodates a sliding seal (“sealing means”, not shown, Col 3 lines 60-65) disposed between the distraction shaft and the splined housing (not shown but see Fig 1 , Col 3 lines 60-65 where the seal would be between the shaft and housing) to seal off the interior of the housing as the shaft telescopes from the housing (Col 3 lines 60-65).
It would have also been obvious to one having ordinary skill in the art at a time before the invention was made to modify Pool as modified to have the splined housing have a tapered area that accommodates sliding seal disposed between the shaft and the splined housing in view of further teachings of Schwarzler because the seal seals off the interior of the housing as the shaft telescopes from the housing.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pool US 2009/0112263, as evidenced by Pruyn US 1,340,250, and Schwarzler US 6,918,838, as applied to claim 10 above, and in further view of Stauch US 6,416,516.
Pool as modified discloses the claimed invention as discussed above but does not disclose the sliding seal comprises: a lip seal flange attached to the splined housing; a lip seal including: a base portion configured to seal against an inner diameter of the lip seal flange; one or more protrusions disposed about an inner diameter of the lip seal, the one or more protrusions being configured to slidingly seal against the axial groove of the distraction shaft; and an inner surface configured to slidingly seal against an outer diameter of the distraction shaft.
Stauch, pertinent in the field of seals, discloses a housing (#1.2), a moveable shaft (#6, Col 2 lines 45-53) located in the housing (Fig 1), a sliding seal (#9.2, shaft #6 slides along the seal, Col 2 lines 45-53) comprising: a lip seal flange attached to the splined housing (see Fig below, Col 1 lines 45-50, the seal tapers thus forming a flange and a base portion);
a lip seal (see Fig below) including:
a base portion configured to seal against an inner diameter of the lip seal flange (see Fig below, Col 1 lines 45-50 “leak tight”); and an inner surface configured to slidingly seal against an outer diameter of the distraction shaft (see Fig below, Col 1 lines 45-50, Col 2 lines 45-55), where the seal provides for a leak tight seal (Col 1 lines 45-50).
PNG
media_image2.png
584
792
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the seal of Pool as modified to be a sliding seal with the lip seal flange and base portion (discussed above) in view of Stauch above because this is a known type seal to be “leak tight”.
With regards to “the one or more protrusions”, it would be obvious that the inner diameter would include protrusions to correspond with the axially extending grooves of the shaft (see Fig 1 in Schwarzler where the axial grooves #32 of the distraction shaft extend along the length of the shaft and portions thereof would be located outside the housing during use) so as to provide sufficient sealing of the interior of the housing. In other words, the lip seal would obviously need to conform to the outer profile of the shaft in order to provide sufficient sealing. In doing so, there would need to be protrusions that would fill in and seal the axial grooves.
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pool US 2009/0112263, Schwarzler US 6,918,838 (cited by applicant), and Stauch US 6,416,516, as applied to claim 11 above, and in further view of Traub US 4,570,944.
Pool as modified discloses the claimed invention as discussed above but does not disclose the lip seal comprises silicone, EPDM, or another rubber material.
Traub discloses a lip seal (#12, Col 3 lines 62-67) that is made from rubber (Col 5 lines 5-10).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Pool as modified to have the lip seal comprise a rubber material in view of Traub above because this is a known type of material to form a lip seal.
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pool US 2009/0112263, as evidenced by Pruyn US 1,340,250,, Schwarzler US 6,918,838 (cited by applicant), and Stauch US 6,416 (cited by applicant), as applied to claim 11 above, and in further view of Gerrone US 5,458,640
Pool as modified discloses the claimed invention above where the distraction shaft slides along the lip seal (as discussed above in claim 11) but does not disclose the lip seal is coated with silicone oil.
Gerrone, pertinent in the field of seals, discloses a housing (#110), a shaft (#112) and a seal (#19), the seal and shaft movbeable relative to each other (Fig 4-5), the seal is coated with silicone oil (Col 3 lines 25-30, Col 7 lines 35-40) which provides a lubricant to reduce frictional resistance.
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify Pool as modified to coat the lip seal with silicone oil in view of Gerrone because this provides a known lubricant to reduce frictional resistance.
Claim 14-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pool US 2009/0112263, as evidenced by Pruyn US 1,340,250, and Schwarzler US 6,918,838 (cited by applicant), as applied to claims 5, 2, 7, 6 above, and in further view of Fujiwara US 6,328,474.
Pool as modified discloses the claimed invention as discussed above where the ball is in contact with the axial groove on the outer surface of the distraction shaft, the axial groove on the inner diameter surface of the splined housing and the ball cage (Fig 1 in Schwarzler) but does not disclose, wherein the ball is coated with silicone oil or a liquid perfluorinated polyether, wherein the axial groove on the outer surface of the distraction shaft is coated with silicone oil or a liquid perfluorinated polyether, wherein the axial groove on the inner diameter surface of the splined housing is coated with silicone oil or a liquid perfluorinated polyether, wherein the ball cage is coated with silicone oil or a liquid perfluorinated polyether.
Fujiwara, pertinent to the problem of lubricating balls, discloses that balls (#3) and surfaces (#1a, #1b, #202a, #202b) contacting the balls (Fig 2) are coated with liquid perfluorinated polyether (PFPE)(Col 3 lines 55-60, Col 4 lines 25-35) to lubricate the balls and the surfaces contacting the ball.
It would have been obvious to one having ordinary skill in the art at a time before the invention was made to modify Pool as modified and apply a coating of liquid PFPE to the ball, the axial groove on the outer surface of the distraction shaft, the axial groove on the inner diameter surface of the splined housing and the ball cage in view of Fujiwara because PFPE provides lubrication to the balls and the other surfaces contacting the ball.
Claim 18-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pool US 2009/0112263, as evidenced by Pruyn US 1,340,250, in view of Schwarzler US 6,918,838.
Regarding Claim 18, Pool discloses a lengthening device (Fig 6c) configured for placement between a first bone section and a second bone section, the device comprising:
a distraction shaft (#146) configured for fixation to a first bone section of a long bone (able be fixed using a clamp or use of screws and connectors, Fig 4, where this limitation is intended use and the shaft is able to be placed on a long bone);
a housing (#150) configured for fixation to a second bone section of the long bone (able to be fixed using a clamp or use of screws and connectors, Fig 4 where this limitation is intended use and the housing is able to be placed on a long bone), wherein the distraction shaft is disposed at least partially within the housing (Fig 6c, paragraph 77, 89); and
an actuator (#218, #226) configured to increase at least one of a distraction force between the distraction shaft and the housing and a length of the lengthening device (paragraph 90), the actuator including:
a permanent magnet (#218) being configured for rotation relative to the housing (paragraph 90); and
a lead screw (#226) operatively coupled to the permanent magnet via a gear assembly (#240, #238, Fig 6d-6g),
the actuator including a thrust bearing (“A second ball optional bearing [not shown] can be included on the opposite end of the magnetic element 218” end of paragraph 88)(it is noted that ball bearing are known in the mechanical art as being ring shaped with a center through opening, as evidenced by Pruyn, Fig 1 which shows a typical ball bearing with a center through opening #3) disposed about a portion (shaft of a gear assembly, see Fig below) of a gear assembly (see Fig 6g below the opposite end of the magnet has a shaft of a gear assembly extending therefrom and as discussed at the end of paragraph 88, the ball/thrust bearing would be placed on the opposite end of magnet #218 and about the about the lower end of the shaft of the gear assembly, where the shaft would extend through the through opening of the thrust/ball bearing).
PNG
media_image1.png
612
839
media_image1.png
Greyscale
In the alternative, Pool does not disclose explicitly disclose the distraction shaft configured for fixation to a first bone section of a long bone, the housing configured for fixation to a second bone section of the long bone.
Pool discloses the distraction device can be used in other applications/bone such as long bones (paragraph 185, see also Fig 53, paragraph 129).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the device of Pool to be sized to be used on long bone in view of additional teachings of Pool because this provides known alternate use for the distraction device on other bones.
Pool also discloses a portion of the housing (“overlapping region” of the housing #150, second sentence of paragraph 77) configured to allow sliding of the distraction shaft within the housing (paragraph 77, 89) but does not disclose an axial groove disposed on an outer surface of the distraction shaft, a ball disposed within the axial groove disposed on the distraction shaft, a ball cage disposed over the distraction shaft and the ball, the ball cage being configured to trap the ball within the axial groove; a splined housing disposed over the ball cage and the ball, the splined housing having an axial groove disposed along an inner diameter surface of the splined housing, wherein the ball cage and the ball are interposed between the distraction shaft and the splined housing, wherein the ball is constrained by the ball cage, and is configured to be disposed at least partially within the axial groove disposed on the distraction shaft, and at least partially within the axial groove disposed on the splined housing, thereby rotationally locking the splined housing to the distraction shaft, while allowing axial displacement of the distraction shaft relative to the splined housing.
Schwarzler, pertinent to the problem of low friction telescoping movement as well as prevention of rotation, discloses a distraction shaft (#31) having an internal cavity (as seen in Fig 1, 8), a housing (#21), wherein the distraction shaft is configured to be telescopingly displaceable relative to and disposed partially within the housing (Fig 1, Col 1 lines 30-40),
an axial groove (#32) disposed on an outer surface of the distraction shaft (Fig 1),
a ball (#41) disposed within the axial groove disposed on the distraction shaft (Fig 1),
a ball cage (#42) disposed over the distraction shaft and the ball (fig 1), the ball cage being configured to trap the ball within the axial groove (claim 1);
a splined housing (portion of housing #21 that overlaps with the shaft #31 that contains grooves #22, where this region contains the axial grooves #32, #22 and balls #41, Fig 1) disposed over the ball cage and the ball (Fig 1),
the splined housing having an axial groove (#22) disposed along an inner diameter surface of the splined housing (Fig 1),
wherein the ball cage and the ball are interposed between the distraction shaft and the splined housing (Fig 1),
wherein the ball is constrained by the ball cage (Fig 1, claim 1), and is configured to be disposed at least partially within the axial groove disposed on the distraction shaft (Fig 1), and at least partially within the axial groove disposed on the splined housing (Fig 1), thereby rotationally locking the splined housing to the distraction shaft (claim 1), while allowing axial displacement of the distraction shaft relative to the splined housing (Col 1 lines 30-43), wherein the ball, the axial grooves, and call cage provides for low friction sliding of the shaft (Col 1 lines 30-43).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Schwarzler to include a ball, the housing defining a splined housing with an axial groove, the shaft having an axial grove, the grooves to receive the ball and a ball cage to fix the ball in place in view of Schwarzler because this allows for low friction sliding of the shaft relative to the housing and prevent rotation. The examiner notes that with the modification, the housing is provided with a splined configuration which would define the splined housing that allows for sliding and prevent rotation.
Regarding Claim 19, Pool as modified discloses a seal (#216 in Pool, paragraph 88 in Pool) but does not disclose a sliding seal disposed between the distraction shaft and the splined housing.
Schwarzler further discloses the shaft (#31) extending from a tapered area (#25, #26, Fig 1) of the housing, the tapered area accommodates a sliding seal (“sealing means”, not shown, Col 3 lines 60-65) disposed between the distraction shaft and the splined housing (not shown but see Fig 1 , Col 3 lines 60-65 where the seal would be between the shaft and housing) to seal off the interior of the housing as the shaft telescopes from the housing (Col 3 lines 60-65).
It would have also been obvious to one having ordinary skill in the art at a time before the invention was made to modify Pool as modified to have the splined housing have a tapered area that accommodates sliding seal disposed between the shaft and the splined housing in view of further teachings of Schwarzler because the seal seals off the interior of the housing as the shaft telescopes from the housing.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pool US 2009/0112263, as evidenced by Pruyn US 1,340,250, and Schwarzler US 6,918,838 (cited by applicant), as applied to claim 10 above, and in further view of Stauch US 6,416,516.
Pool as modified discloses the claimed invention as discussed above but does not disclose the sliding seal comprises: a lip seal flange attached to the splined housing; a lip seal including: a base portion configured to seal against an inner diameter of the lip seal flange; one or more protrusions disposed about an inner diameter of the lip seal, the one or more protrusions being configured to slidingly seal against the axial groove of the distraction shaft; and an inner surface configured to slidingly seal against an outer diameter of the distraction shaft.
Stauch, pertinent in the field of seals, discloses a housing (#1.2), a moveable shaft (#6, Col 2 lines 45-53) located in the housing (Fig 1), a sliding seal (#9.2, shaft #6 slides along the seal, Col 2 lines 45-53) comprising: a lip seal flange attached to the splined housing (see Fig below, Col 1 lines 45-50, the seal tapers thus forming a flange and a base portion);
a lip seal (see Fig below) including:
a base portion configured to seal against an inner diameter of the lip seal flange (see Fig below, Col 1 lines 45-50 “leak tight”); and an inner surface configured to slidingly seal against an outer diameter of the distraction shaft (see Fig below, Col 1 lines 45-50, Col 2 lines 45-55), where the seal provides for a leak tight seal (Col 1 lines 45-50).
PNG
media_image2.png
584
792
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the seal of Pool as modified to be a sliding seal with the lip seal flange and base portion (discussed above) in view of Stauch above because this is a known type seal to be “leak tight”.
With regards to “the one or more protrusions”, it would be obvious that the inner diameter would include protrusions to correspond with the axially extending grooves of the shaft (see Fig 1 in Schwarzler where the axial grooves #32 of the distraction shaft extend along the length of the shaft and portions thereof would be located outside the housing during use) so as to provide sufficient sealing of the interior of the housing. In other words, the lip seal would obviously need to conform to the outer profile of the shaft in order to provide sufficient sealing. In doing so, there would need to be protrusions that would fill in and seal the axial grooves.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773