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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 2, 2026 has been entered.
Status of Claims
Claim 1-20 and 29 are examined.
Claims 21-28 are withdrawn with traverse.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 5 - “bone cement paste” should read “the bone cement paste” for the purpose of claim language consistency because claim 1 already recites “bone cement paste” in line 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 1-20 and 29 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 1 recites the limitation "the medical field" in line 2. There is insufficient antecedent basis for this limitation in the claim because prior to the cited limitation, claim 1 fails to define “a medical field”.
Claim 1 recites the limitation “the surroundings of the casting mold” in line 14. There is insufficient antecedent basis for this limitation in the claim because prior to the cited limitation, claim 1 fails to disclose “surroundings of the casting mold”.
Claim 1 recites the limitation “the region of the spherical surface-shaped” in line 17. There is insufficient antecedent basis for this limitation in the claim because prior to the cited limitation, claim fails to define “a region of the spherical surface-shaped inner surface”.
Claim 1 recites the limitation “the context of the two-stage revisions septic replacement operations” in line 19. There is insufficient antecedent basis for this limitation in the claim because prior to the cited limitation, claim 1 fails to define “a context of the two-stage revisions septic replacement operations”.
As claim 2-20 and 29 ultimately depend on claim 1, claims 2-20 and 29 are rejected for indefiniteness.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 8, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1).
Regarding Claim 1, Smith discloses device for producing a spacer (c. 4, L 21 – a cement mold 10) by curing bone cement paste (c. 6, L 21-22 – filled cement mold 10 let the bone cement 82 cure), wherein the spacer is provided in the medical field for temporarily replacing a joint or part of a joint comprising an articulating surface of a head of the joint (c. 4, L 23-25 – to form a temporary femoral hip implant or prosthesis 80), the device comprising:
a casting mold (c. 4, L 21 – a cement mold 10) for molding the spacer from bone cement paste (c. 5, L 53-54 – bone cement may be a poly-methyl-methacrylate (PMMA) cement; c. 6, L 41-42 – 80 formed from the antibiotic loaded bone cement 82) wherein the casting mold has a stem mold (c. 4, L 40-42 – stem portion 22, enlarged neck portion 20) for molding a stem (claim 4 – cement mold forms femoral hip implant having a distal stem) and a neck (claim 4 – a neck), and the casting mold has a mold cavity (c. 4, L 40-42 – articulating head portion 18) with a spherical surface-shaped inner surface (c. 4, L 51-53 – inner hemispherical sidewall 30 used to form a substantially spherical articulating head; Fig. 3 depicts a “spherical surface-shaped inner surface” for 18) for molding a sliding surface of a head of the spacer (claim 4 – cement mold forms femoral hip implant having a head), wherein the stem mold and the mold cavity delimit a common interior (c. 4, L 48-53 – inner side wall 26 defines the entire shape of the temporary implant and inner hemispherical sidewall 30; c. 5, L 25-27 – fully assembled 10 creates a substantially completely enclosed cement mold; Fig. 2 depicts a common interior for 18, 20, and 22), such that, as the spacer is molded from the bone cement paste, the head of the spacer molded in the casting mold is connected to the stem as one part via the neck because of the common interior (c. 6, L 5-7 – cement gun 72 to pump out the bone cement 82 within 26 of 10; therefore forms 18, 20, and 22 as one connected part);
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Fig. 1 of Smith
wherein the neck is entirely formed in the stem mold (c. 4, L 40-42 – enlarged neck portion 20; claim 4 – cement mold forms femoral hip implant having a neck)
at least one filling opening (c. 5, L 26-27 – input port 66) for injecting a bone cement paste into the casting mold (c. 6, L 4-7 – nozzle 70 sealing 66, the cement gun 72 is engaged to pump out the bone cement 82 within 26)
at least one vent element (c. 5, L 31-32 – a plurality of vent holes 74) which connects the common interior of the casting mold in a gas-permeable manner to the surroundings of the casting mold (c. 6, L 7-10 – air trapped within 10 is released, via 74),
wherein the stem mold is dimensionally stable (c. 4, L 28- 10 formed from silicone having a sufficiently high stiffness) on injection of bone cement paste into the casting mold (c. 6, L 4-8 –pump out the bone cement 82 within 26; 82 delivered within 10)
The limitation “for producing a spacer” and “the spacer is a temporary placeholder for an interim phase in the context of two-stage revisions septic replacement operations for endoprostheses for hip and shoulder total articular endoprostheses” recites a manner of operating the device for an intended use. 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. See MPEP § 2114 (II).
As Smith discloses that the cement mold is to form a temporary femoral hip implant or prosthesis (c. 4, L 21-25), the cement mold is capable of performing the intended use of “for producing a spacer” and “the spacer is a temporary placeholder for an interim phase in the context of two-stage revisions septic replacement operations for endoprostheses for hip and shoulder total articular endoprostheses.” The limitation does not add further structure to the claimed apparatus and thus because the cement mold in Smith is capable of performing the intended use, it meets the limitations as claimed.
Smith discloses cement molds will be supplied in an array of sizes to meet various patient’s needs (c.5, L 66-67)
Modified Smith does not teach on injection of bone cement paste into the casting mold, the mold cavity is expanded, at least in the region of the spherical surface-shaped inner surface, by pressure imparted by the injected bone cement paste.
Analogous art Henderson discloses a method a forming a hip prosthesis including a femoral component 26 (a stem) and a femoral head component 28 (c. 6, L 50-56; Fig. 8). The femoral component having an inlet for cement injection (c. 5, L 4-7). The femoral component 26 is inserted into femoral canal 22 of the patient (c. 7, L 15-16, 41-42) and expandable to fill the spatial confines of the reamed femoral canal 22 (dimensionally stable on injection of bone cement paste) (claim 1). The femoral head component 28 includes deflated balloon 28a, which when inflated with a molding, for example bone cement (polymethylmethacrylate), would take the form of hip hemiarthroplasty component 28b (c. 6, L50-56).
Henderson further teaches on injection of bone cement paste into the casting mold, the mold cavity is expanded (c. 6, L 50-56; Fig. 8 – 28 includes deflated balloon that is inflated with bone cement to take form of hip hemiarthroplasty component 28b), at least in the region of the spherical surface-shaped inner surface (c. 7, L 56-61; Fig. 15 – the spherical 28b inflated), by pressure imparted by the injected bone cement paste (c. 7, L 56-61; Fig. 15 – when injected with molding; pressure would inherently be present due to the injection in an enclosed space). The deflated balloon becomes inflated and similar to a neo-femoral head (c. 2, L 63-65). Injecting molding into the hip prosthesis forms an inflated position, such that the deflated balloon becomes inflated to expand within the reamed formal neck and to form an inflated balloon that resembles the femoral head of the subject (claim 1).
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Fig. 14 and 15 of Henderson
Smith and Henderson disclose apparatuses with the same or similar components performing the same or similar function in forming a hip replacement using polymethylmethacrylate bone cement. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the femoral head component including a balloon in Henderson to the articulating head portion in Smith to form an inflated balloon that resembles the femoral component superficially resembling a typical hemiarthroplasty component (Henderson c. 5, L. 1-3) and that resembles the femoral head of the subject, such that the inflated ballon can completely replace the femoral head of the subject (Henderson claim 1) and achieve array of sizes to meet various patient’s needs (Smith c.5, L 66-67).
Regarding Claim 2, modified Smith teaches the device according to claim 1.
Modified Smith further teaches the device characterized in that the at least one vent element is permeable to gases (c. 6, L 7-10 – air trapped within 10 is released, via 74) and is impermeable to bone cement paste (c. 2, L 52-54 – cement is substantially sealed to define the temporary implant; c. 5, L 25-27 – fully assembled 10 creates a substantially completely enclosed cement mold; therefore, the vents 74 are permeable to gas/air and impermeable to bone cement paste), in particular to polymethyl methacrylate bone cement paste (PMMA bone cement paste) (c. 5, L 53-54 – bone cement may be a poly-methyl-methacrylate (PMMA) cement).
Regarding Claim 3, modified Smith teaches the device according to claim 1.
Modified Smith discloses the device characterized in that the mold cavity is elastically expandable (Henderson c. 2, L 63-65 – deflated balloon becomes inflated and similar to a neo-femoral head), at least in the region of the spherical surface-shaped inner surface (Henderson 28), by the pressure imparted by the injected bone cement paste (Henderson claim 1 - Injecting molding forms an inflated position, such that the deflated balloon becomes inflated to expand to form an inflated balloon that resembles the femoral head of the subject).
Regarding Claim 8, modified Smith teaches the device according to claim 1.
Modified Smith further teaches the device characterized in that, at least in the region of the spherical surface-shaped inner surface, the mold cavity expands by injection (Henderson c. 7, L 56-61; Fig. 15 – 28b inflated when injected with molding) of further bone cement paste into the casting mold already completely filled with bone cement paste (Henderson claim 1 – 26 expandable to fill the spatial confines of the reamed femoral canal 22), while the stem mold receives no additional bone cement paste and remains dimensionally stable (as the 28b is inflated when injected with molding while 26 is filled to the confines of 22, when 26 is filled, the injection molding after would fill 28b to inflate it as it is not confined).
The limitation “at least in the region of the spherical surface-shaped inner surface, the mold cavity expands by injection of further bone cement paste into the casting mold already completely filled with bone cement paste, while the stem mold receives no additional bone cement paste and remains dimensionally stable” recites a manner of operating the device for an intended use. 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. Because the femoral component and femoral head portion in Henderson is capable of performing the intended use, it meets the limitations as claimed. See MPEP § 2114 (II).
Regarding Claim 29, modified Smith teaches the device according to claim 1.
Smith discloses the spacer is fabricated in one part from a biocompatible bone cement paste (c. 6, L 5-7 – cement gun 72 to pump out the bone cement 82 within 26 of 10; therefore forms 18, 20, and 22 as one connected part), wherein the bone cement paste comprises at least one antibiotic releasable from the bone cement of the spacer (c. 5, L 47-61 – bone cemented mixed with appropriate antibiotic, bone cement may be a poly-methyl-methacrylate (PMMA) cement, antibiotic may be gentamicin or any other appropriate antibiotic).
The limitation “the spacer is fabricated in one part from a biocompatible bone cement paste” recites a manner of operating the device for an intended use. See MPEP § 2114 (II).
As Smith discloses that the cement mold is to form a temporary femoral hip implant or prosthesis (c. 4, L 21-25) and pump out the bone cement 82 within inner side wall 26 of mold 10 (c. 6, L 5-7), the cement mold is capable of performing the intended use of “the spacer is fabricated in one part from a biocompatible bone cement paste”. The limitation does not add further structure to the claimed apparatus and thus because the cement mold in Smith is capable of performing the intended use, it meets the limitations as claimed.
The limitation “wherein the bone cement paste comprises at least one antibiotic or antimycotic releasable from the bone cement of the spacer” recites the material or article worked upon by the apparatus. Applicant is reminded material or article worked upon does not limit apparatus claims. See MPEP § 2115.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1 above, and further in view of Foroni (US 2020/0316824 A1).
Regarding Claim 4, modified Smith teaches the device according to Claim 1, but fails to disclose the limitations of claim 4.
Analogous art Foroni teaches a stem mold (¶ [0077] - stalk 7a’, 7a”) and the mold cavity (¶ [0088] - third molding element 7b’ for the forming of a spacer head) are connected or connectable to form a connection to one another in a liquid-tight manner via a first flange (¶ [0090] - flange 71’, 71”), wherein a part of the mold cavity (¶ [0088]; Fig. 5 – 7b’ with concavity 300), which comprises the spherical surface-shaped inner surface (300), is fastenable with an annular mount (¶ [0110] – head structure 100”) to a second flange (71’, 71”) of the stem mold (7a’, 7a”), such that a peripheral annular disk (¶ [0089] - annular flange 71) of the expandable part of the mold cavity is arranged between the annular mount and the second flange and seals the connection (Fig. 5-6 – depicts 71 is arranged between 100” and 71”, 71’ to seal connection of 7a’, 7a” and 7b’). The connectable flange configuration as described above provides the benefit of enhanced pressure adjustment and connection between the stem mold and mold cavity (¶ [0105]).
Smith and Foroni disclose apparatuses with the same or similar components performing the same or similar function in regards to a bone cement mold. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the connectable flange configuration of Foroni to the mold of modified Smith to obtain the benefit of enhanced pressure adjustment and connection (¶ [0105]).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1, in further view of Ziran (US 2007/0222114 A1).
Regarding Claim 5, modified Smith teaches the device according to claim 1, wherein Smith further discloses the device characterized in that the device has a fastening element (c. 5, L 2-5 – halves 12, 14 of 10 are joined by means of a connecting or coupling mechanism 56) for fastening the mold cavity to the stem mold (as stem portion 22, neck portion 20, and head portion are joined to form 10, they are fastened).
Analogous art Ziran discloses device to fabricate a cement spacer (¶ [0013]) comprising cement molds for hip and knee joints (¶ [0086).
Ziran further discloses wherein the fastening element is detachable and comprises a plurality of screws (¶ [0094] - clockwise or counterclockwise rotation of one mold segment; therefore, is detachable).
Smith and Hartman disclose apparatuses with the same or similar components performing the same or similar function in regards to a bone cement mold. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply the female-male rotation geometry of Hartman to the mold of Smith to allow all the channels of the respective mold segmented parts being in fully alignment (¶ [0094]).
Regarding Claim 6, modified Smith teaches the device of claim 5.
Smith does not disclose the device characterized in that the fastening element has clamping plates.
Ziran further discloses the device characterized in that the fastening element has clamping plates (¶ [0094] – joinder clips 65).
Smith and Hartman disclose apparatuses with the same or similar components performing the same or similar function in regards to a bone cement mold. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply the joinder clips of Hartman to the mold of Smith to allow all the channels of the respective mold segmented parts being in fully alignment and hold certain combinations of mold segments together manually (¶ [0094]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1 above, and further in view of Haney (US 2009/0146342 A1) and Vogt 2 (US 2017/0259232 A1).
Regarding Claim 7, modified Smith teaches the device according to Claim 1, wherein Smith discloses the device characterized in that the at least one filling opening (c. 5, L 26-27 – input port 66) is connected on a side remote from the casting mold to a bone cement delivery device nozzle (c. 6, L 4-7 – nozzle 70 sealing 66, the cement gun 72 is engaged to pump out the bone cement 82 within 26)
Smith does not disclose the at least one filling opening is connected on a side remote from the casting mold to a port for liquid-tight connection of a bone cement cartridge, wherein the port is suitable for pressure-tight connection of a bone cement cartridge, wherein the port has a thread and a circumferential seal and/or a circumferential sealing face or a circumferential sealing edge.
Haney teaches a filling opening (¶ [0036] - access to the interior of stem portion 14) is connected on a side remote from the casting mold to a port (¶ [0036] - port 106 that provides access) for liquid-tight connection of a bone cement cartridge (¶ [0038] – nozzle 113 of cement gun/cartridge 12), wherein the port is suitable for pressure-tight connection of a bone cement cartridge, wherein the port has a thread (¶ [0038] – threaded nozzle) and a circumferential sealing edge (¶ [0038] - cylindrical wall 110 with thread thereon). The port configuration provides the benefit of enhanced connection between the delivery device/bone cement cartridge and the casting mold thereby ensuring no unintentional disconnect between the two (¶ [0037]).
Smith and Haney disclose apparatuses with the same or similar components performing the same or similar function in regards to a bone cement mold. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the port configuration of Haney in the mold of modified Smith to obtain the benefit of an enhanced connection between the bone cement cartridge and the casting mold (¶ [0037]).
In addition, Vogt 2 teaches an analogous delivery device having a bone cement cartridge 1 (¶ [0095]) that provides the benefit of a device with a simpler storage and mixing system allowing for filling of the mold without the need of mixing and measuring of the bone cement ahead of time (¶ [0004, 0015]).
Smith and Vogt 2 disclose apparatuses with the same or similar components performing the same or similar function in regards to a bone cement mold. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the bone cement cartridge as taught by Haney and Vogt 2 to the device of modified Smith to obtain the benefit of a simpler storage and mixing system allowing for filling of the mold without the need of mixing and measuring of the bone cement ahead of time (Vogt 2 ¶ [0004, 0015]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1 above, and further in view of Vogt 1 (US 2013/0187310 A1) and Vogt 3 (US 2014/0077115 A1).
Regarding Claim 9, modified Smith teaches the device according to Claim 1, but fails to disclose the limitations of claim 9.
Vogt 1 teaches an analogous mold device for producing a spacer (¶ [0050] – hollow mold 1) wherein the device is characterized by a valve seat (¶ [0042] - rotary valve), which is connected to the casting mold in the region of the at least one filling opening (¶ [0027] – valve element at filling opening), wherein the valve seat has in places a closed head side with at least one first feed-through (See annotated Fig. 1 below; ¶ [0027] – valve element at filling opening and hollow space; closed valve seals hollow shape), wherein the at least one first feed-through opens into the at least one filling opening (¶ [0027] – at filling opening), and a rotatable valve body (¶ [0027] – roller-shaped rotating element) which is mounted so as to be rotatable relative to the valve seat (¶ [0027] – rotary, inherently rotates), wherein the valve seat and the valve body together form a valve (¶ [0027] – rotary valve 3), wherein the valve is reversibly transferable into an open position and a closed position by rotation of the valve body relative to the valve seat (¶ [0020, 0027] – open to allow cement fill in and closed to be sealed), wherein, in the open position of the valve, the at least one first feed through of the valve seat and the at least one second feed-through of the valve body are located above one another at least in places and provide a connection permeable to bone cement through the valve into the casting mold (See annotated FIG.1 below; [0027] – valve is opened to allow the cement to be filled in), wherein, in the closed position of the valve, the at least one filling opening of the casting mold is covered against bone cement paste (¶ [0020] - closed such that hollow space is being sealed; therefore, no bone cement paste would be allowed to enter as the filling opening of the casting mold is covered). The valve configuration provides the benefit of sealing the mold in a gas tight manner (¶ [0027]).
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Smith and Vogt 1 disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the valve configuration of Vogt 1 to the mold of modified Smith to obtain the benefit of sealing the mold in a gas tight manner (¶ [0027]).
Modified Smith does not explicitly state in Vogt 1 that the valve body has a sealing face, wherein the sealing face is oriented in the direction of the in places closed head side of the valve seat wherein at least one second feed-through is arranged in the sealing face; further in the closed position of the valve, the at least one first feed-through of the valve seat is covered by the sealing face of the valve body.
Vogt 3 teaches an analogous rotary valve body for bone cement dispensing (¶ [0034] – rotary valve body) wherein the valve body has a sealing face (¶ [0034] - sealing cam), wherein the sealing face is oriented in the direction of the in places closed head side of the valve seat (¶ [0036] – side of valve seat with opening) wherein at least one second feed-through (¶ [0036] - opening of rotary valve body) is arranged in the sealing face; further in the closed position of the valve, the at least one first feed-through of the valve seat (¶ [0064] – valve seat with opening into feed-through) is covered by the sealing face of the valve body (¶ [0064] – opening is arranged adjacent to sealing cam 30). The rotary valve body configuration described above provides the benefit of a simple and reliable valve seat and body configuration (¶ [0016, 0024]).
Smith and Vogt 3 disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the rotary valve body configuration of Vogt 3 to the valve of modified Smith to obtain the benefit of a simple and reliable valve seat and body configuration (¶ [0016, 0024]). In addition, one of ordinary skill in the art would have found it obvious the valve configuration of Vogt 1 would include the rotary valve features of Vogt 3 based on the nature of rotary valve operation.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied in claim 1, in view of Vogt 1 (US 2013/0187310 A1), and Vogt 3 (US 2014/0077115 A1), as applied to claim 9 above, and further in view of Vogt 2 (US 2017/0259232 A1).
Regarding Claim 10, modified Smith teaches the device according to claim 9
Smith does not disclose the device characterized in that the valve is connected on the side remote from the casting mold to a port for liquid-tight connection of a bone cement cartridge or the valve has such a port and/or the valve seat is connected to the casting mold so as not to be rotatable relative to the casting mold.
Vogt 3 further teaches the valve connected on a side remote from the casting mold (i.e., the side of the valve not connected to the casting mold; thus, the side connected to the dispensing device), to a port (¶ [0068] – sealing cam 118) for liquid tight connection of a bone cement cartridge (¶ [0070] – cartridge 142; FIg. 6 depicts the 118 connecting 142). The valve provides the benefit of a pressure-tight connection (¶ [0070]).
Smith and Vogt 3 disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the sealing cam connect to cartridge in Vogt the mold in Smith to obtain the benefit of a pressure-tight connection (¶ [0070]).
In addition, Vogt 2 teaches an analogous delivery device having a bone cement cartridge (¶ [0055] – cartridge 1) which provides the benefit of a device with a simpler storage and mixing system that allows for filling of the mold without the need of mixing and measuring of the bone cement ahead of time (¶ [0004, 0015]).
Smith and Vogt 2 disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the bone cement cartridge as taught by Vogt 2 to the mold in modified Smith to obtain the benefit of a simpler storage and mixing system allowing for filling of the mold without the need of mixing and measuring of the bone cement ahead of time (¶ [0004, 0015]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1, in view of Vogt 1 (US 2013/0187310 A1), and Vogt 3 (US 2014/0077115 A1), as applied to claim 9 above, as evidenced by Vogt 4 (US 2018/0289406 A1).
Regarding Claim 11, modified Smith teaches the device according to Claim 9.
Modified Smith teaches the valve is operable from outside the device (Vogt 1 Fig. 1 depicts valve 3 outside of hollow mold 1), wherein the valve body is rotatable relative to the valve seat and the valve is transferable by rotation from the closed position into the open position and from the open position into the closed position (Vogt 1 ¶ [0020, 0027] – open and closed rotary valve).
Although Vogt 1 does not explicitly state the valve is manually operable, one of ordinary skill in the art would find it obvious that a rotary valve without some sort of automated control system would be manually rotated wherein it is typical in the art for this type of valve to be manually operated as evident by Vogt 4 (¶ [0192, 0204]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1, in view of Vogt 1 (US 2013/0187310 A1) and Vogt 3 (US 2014/0077115 A1) as applied to claim 9 above, and further in view of Ye (CN 201335161 Y, an English machine translation was provided in a previous office action).
Regarding Claim 12, modified Smith teaches the device according to Claim 9.
Smith does not disclose the device characterized in that the valve seat has an inner thread on the inside and the valve body has a matching outer thread on the outside, such that the valve body can be screwed into the valve seat and/or the port comprises, for liquid-tight connection of a bone cement cartridge, an inner thread in the valve body or an outer thread on the valve body, wherein an adapter element of the bone cement cartridge or on the bone cement cartridge has a mating thread matching the inner thread or the outer thread.
Ye teaches an analogous valve seat and body configuration (¶ [0021] – valve body 11) wherein the valve seat (¶ [0021] - valve seat 12) has inner thread (¶ [0021] – inner thread edge surface) on the inside and the valve body (¶ [0021] - 11 with end 13) has a matching outer thread on the outside (¶ [0004] - outer thread), such that the valve body can be screwed into the valve seat (given these threads connect the seat and body, valve body can be screwed into the valve seat ¶ [0004, 0021]). The valve seat provides the benefit of improved compressive strength and connections (Abstract).
Smith and Ye disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the valve seat and body configuration of Ye to the mold in Smith to obtain the benefit of improved compressive strength and connections (Abstract).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1 above, and further in view of Vogt 2 (US 2017/0259232 A1).
Regarding Claim 13, modified Smith teaches the device according to Claim 1. Smith further discloses the device comprising a bone cement delivery device nozzle cement gun 72 to pump out the bone cement 82 within 26 of 10 (c. 6, L 5-7).
Smith does not disclose the device characterized in that the device has a bone cement cartridge for mixing bone cement starting components and for delivering mixed bone cement paste from the bone cement cartridge and has a bone cement cartridge for mixing polymethyl methacrylate bone cement starting components and for delivering mixed polymethyl methacrylate bone cement paste from the bone cement cartridge, wherein the bone cement cartridge contains the bone cement starting components for producing the bone cement in mutually separate regions.
Vogt 2 teaches a bone cement cartridge (¶ [0095] – a bone cement cartridge 1) for an analogous delivery device (¶ [0015] – material delivery devices) characterized in that the device has a bone cement cartridge (1) for mixing (¶ [0134] - mixing system) bone cement starting components (¶ [0079] – two cement components) and for delivering mixed bone cement paste (¶ [0098] – two-component PMMA bone cement) from the bone cement cartridge (¶ [0098] – cartridge delivering cement components) and has a bone cement cartridge for mixing polymethyl methacrylate bone cement starting components (¶ [0115] – mixing pasty cement components) and for delivering mixed polymethyl methacrylate bone cement paste (¶ [0098] - two-component PMMA bone cement) from the bone cement cartridge (¶ [0098] – cartridge delivering cement components), wherein the bone cement cartridge contains the bone cement starting components for producing the bone cement in mutually separate regions (¶ [0095] – cement components are separated from one another in the cartridge by means of a partition wall disposed in the inner space of the cartridge).
Vogt 2 states the device provides the benefit of a device with a simpler storage and mixing system for pasty two-component polymethyl methacrylate bone cements that is inexpensive to produce and allows manual mixing and delivery (¶ [0004, 0015]).
Smith and Vogt 2 disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the bone cement cartridge of Vogt 2 to the mold in modified Smith to obtain the benefit of simpler storage and mixing system that allows for filling of the mold without the need for mixing and measuring of the bone cement ahead of time (¶ [0004, 0015]).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1 above, and further in view of Haney (US 2009/0146342 A1).
Regarding Claim 14, modified Smith teaches the device according to Claim 1.
Smith does not disclose the device characterized in that the casting mold has at least three or four cavities, starting from an inner chamber of the casting mold, for receiving retaining pins, wherein the cavities are arranged in the stem mold and the stem mold is in two parts or three parts and the cavities are arranged in edges or in longitudinal flanges of at least one part of the two-part stem mold.
Haney teaches wherein the casting mold (¶ [0020] – spacer mold 10) has at least four cavities (¶ [0044]; Fig. 2 - collars 156, 154) starting from an inner chamber of the casting mold (¶ [0022, 0044] - between the stem members 18, 20), for receiving retaining pins (¶ [0044] – fasteners 150), wherein the cavities are arranged in the stem mold (Fig. 2 – 154 of 18, 156 of 20) and the stem mold is in two parts (18, 20) and the cavities are arranged in edges or in longitudinal flanges (¶ [0044] – flanges 144, 148) of at least one part of the two-part stem mold (Fig. 2; [0044] – 144 in 154, 148 in 148). The cavity/retaining pin configuration provides the benefit of ensuring the proper amount of tension with the mold stem cavity (¶ [0043-0044]).
Smith and Haney disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the cavity/retaining pin configuration of Haney to the stem portion of modified Smith to obtain the benefit of ensuring the proper amount of tension with the mold stem cavity (¶ [0043-0044]).
Regarding Claim 15, modified Smith teaches the device according to Claim 1.
Smith does not disclose a metal core which is to be arranged in the casting mold, the metal core has bores for receiving retaining pins, wherein those bores are arranged within a part of the metal core, which part of the metal core is the be arranged in the stem mold.
Haney teaches a metal core (¶ [0021] – reinforcing bar 26) which is to be arranged in the casting mold (¶ [0041] – spacer mold 10, 26 spaced from an interior surface defining the cavity 22), wherein a metal core has bores (¶ [0041] – protrusion 128; at least one bore/protrusion, in one embodiment specifically being two) for receiving retaining pins (¶ [0041] – projections 124), wherein those bores which are to be arranged within a part of the metal core, which part of the metal core is the be arranged in the stem mold (¶ [0041] – 124 extend outwardly from outer surface 120 from 26 to engage the inner surface 122). Haney states this bore/retaining pin configuration as described above provides the benefit of strengthening the spacer and centering the metal core (¶ [0041]).
Smith and Haney disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the bore/retaining pin configuration of Haney to the mold in modified Smith to obtain the benefit of strengthening the spacer and centering the metal core (¶ [0041]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1 above, and further in view of Vogt 1 (US 2013/0187310 A1) and Wust (US 2016/0332328 A1).
Regarding Claim 16, modified Smith teaches the device according to Claim 1.
Smith fails to disclose the device characterized in that the spherical surface-shaped inner surface of the mold cavity has, in the unexpanded state, a diameter of at least 35 mm or of at least 40 mm, wherein, in the unexpanded state, the diameter of the spherical surface-shaped inner surface of the mold cavity is smaller than the diameter of the spherical surface-shaped inner surface of the mold cavity in the expanded state.
Vogt 1 teaches the spherical surface-shaped inner surface of the mold cavity has in the unexpanded state, the diameter of the spherical surface-shaped inner surface of the mold cavity is smaller than the diameter of the spherical surface-shaped inner surface of the mold cavity in the expanded state (¶ [0024, 0037]).
One of ordinary skill in the art would have known that the diameter of the expanded state would be larger than a diameter of the unexpanded state given a ‘expanded’ cavity would inherently be larger.
Wust teaches the diameter of the surface-shaped inner surface of the mold cavity, wherein this diameter would correspond to the expanded state of the mold cavity, is between 46-75mm, meeting the claimed range of a diameter of at least 35 mm or at least 40 mm, and is selected based on the desired size/sphere diameter of the spacer (¶ [0048, 0077]).
Smith and Wust disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the diameter between 46-75mm in Wust to the head portion in Smith based on the desired size/sphere diameter of the spacer (¶ [0048, 0077]), and further as a matter of engineering choice, because where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP 2144.04 IV A.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Hartman (US 2009/0157189 A1), as applied to claim 1, in further view of Hartman (US 2009/0157189 A1).
Regarding Claim 17, modified Smith teaches the device according to claim 1. Smith further discloses mold 10 formed from silicone (c. 4, L 28). Henderson discloses 30 is made with a liner that includes a flexible material the resists stretching (c. 6, L 57-62).
Smith fails to explicitly disclose the mold cavity, at least in the region of the spherical surface-shaped inner surface, consists of a rubber-elastic material.
Analogous art Hartman discloses a modular cement mold 10 including a heat component mold 12 and having a heat connector 14 therein and a stem component mold 16 (¶ [0023]).
Hartman teaches the mold can be made of any biocompatible material compatible with the bone cement and antibiotic selected (¶ [0022]).
Hartman further discloses at least in the region of the spherical surface-shaped inner surface (12), of a rubber-elastic material (¶ [0022] – 12 of mold 10 made of rubber).
Smith and Hartman disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the known rubber-elastic mold cavity material as taught by Hartman as the compatible mold cavity material of Smith, and in particular the mold cavity, at least in the region of the spherical surface-shaped inner surface, consisting of a rubber-elastic material, because it has been held the selection of a known material based on suitability for its intended use support prima facie obviousness. See § MPEP 2144.07.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1 above, and further in view of Vogt 1 (US 2013/0187310 A1).
Regarding Claim 18, modified Smith teaches the device according to Claim 1.
Smith does disclose the device characterized in that the at least one filling opening contains a shut-off element which, in a closed state, prevents bone cement paste from flowing out of the casting mold through the at least one filling opening.
Vogt 1 discloses wherein the device is characterized in that the at least one filling opening (¶ [0027] - filling opening) contains a shut-off element (¶ [0027] - valve element) which, in a closed state (¶ [0027] - closed valve), prevents bone cement paste from flowing out of the casting mold through the at least one filling opening (¶ [0020, 0027] – closed to seal, opened to allow cement fill). The valve element as described above provides the benefit of sealing the mold in a gas tight manner (¶ [0027]).
Smith and Vogt 1 disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the valve element of Vogt 1 to the mold in modified Smith to obtain the benefit of sealing the mold in a gas tight manner (¶ [0027]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1 above, and further in view of Magagnoli (US 2019/0159904 A1).
Regarding Claim 19, modified Smith teaches the device according to claim 1.
Smith does not disclose the stem mold comprises a length-variable adapter element with which the length of the neck of the spacer is able to be varied, said neck connecting the stem to the head of the spacer, wherein the adapter element is able to be varied in length by a mating connection.
Smith further teaches the device characterized in that the stem mold comprises a length-variable adapter element (¶ [0041] – bridge 125) with which the length of the neck of the spacer is able to be varied (¶ [0041] – 125 can be differing lengths), said neck connecting the stem to the head of the spacer (¶ [0041] – connected to head component 112; See Fig. 9). The adapter element is able to be varied in length by a mating connection thereby providing the benefit of varying the neck length to a high degree of customization (¶ [0041]).
Smith and Vogt disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the length-variable adapter element described above as taught by Hartman to the mold in modified Smith with to obtain the benefit of varying the neck length when desired (¶ [0041]).
Modified Smith fails to state this is a mating connection by means of a screw.
Magagnoli teaches wherein the stem mold (¶ [0093] – stem component 3) comprises a length-variable adapter element (¶ [0093] – 3 comprises shank 13) wherein the length of the neck (¶ [0114] -neck; ¶ [0111] - i.e., the connection means 4) of the spacer is able to be varied (¶ [0114] – neck is varied), said neck connecting the stem to the head of the spacer (¶ [0111] – connection means between 3 and joint component 2), wherein the adapter element is able to be varied in length by a screw connection (¶ [0109] - thread of 13). Magagnoli states this screw connection length-variable adapter element as described above provides a greater resistance to breaking and a precise adaptation to the anatomy of the patient (¶ [0105, 0114]).
Smith and Magagnoli disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the connection means with thread in Magagnoli to the stem portion of modified Smith to obtain the benefit of greater resistance to breaking and precise adaptation (¶ [0105, 0114]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 6155812) in view of Henderson (US 9089432 B1), as applied to claim 1 above, and further in view of Ziran (US 2007/0222114 A1) and Vogt 1 (US 2013/0187310 A1).
Regarding Claim 20, modified Smith teaches the device according to Claim 1. Smith does not disclose the features of claim 20.
Analogous art Ziran discloses device to fabricate a cement spacer (¶ [0013]) comprising cement molds for hip and knee joints (¶ [0086).
Ziran further discloses the device characterized in that the device has a plurality of dimensionally stable mating molds (¶ [0092] – rigid cradle design) which are suitable for receiving the mold cavity (¶ [0092] – mold segment), wherein the dimensionally stable mating molds are embodied by at least one blister pack (¶ [0092] - blister pack) as the dimensionally stable mating molds (¶ [0092] - rigid cradle design).
Smith and Ziran disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the rigid cradle design and blister pack to the mold in modified Smith achieve final implant molds identical in shape and while not foil backed per se and molds could be presses from/pushed out of a blister pack as needed (¶ [0092]).
Smith does not disclose the dimensionally stable mating molds enable a different degree of expansion of the mold cavity, such that, at least in the region of the spherical surface-shaped inner surface, expansion of the mold cavity is limited by the dimensionally stable mating molds to different diameters when the mold cavity is inserted into the respective dimensionally stable mating mold.
Vogt 1 teaches the device has dimensionally stable restricting means for receiving the mold cavity (¶ [0039] - external framework, bracket, or brace) wherein the restricting means enables a pre-determined degree of expansion of the mold cavity (¶ [0051] – ensures expanded final state), such that, at least in the region of the spherical surface-shaped inner surface, expansion of the mold cavity is limited by the dimensionally stable restricting means to a pre-determined diameter when the mold cavity is inserted into the restricting means (¶ [0051] – expanded final state be defined as exactly as possible). Based on the desired pre-determined shape of the expanded mold (said expanded mold has different diameters dependent on said pre-determined shapes), the restricting means would enable different degrees of expansion based on the desired diameter of the spacer (¶ [0051]).
Smith and Vogt 1 disclose apparatuses with the same or similar components performing the same or similar function. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the restricting means of Vogt 1 to the mold in modified Smith thereby ensuring the desired expanded final state of the expandable mold cavity. Vogt 1 states the restricting means described above provides the benefit of ensuring a desired external shape of the mold cavity in the expanded final state (¶ [0051]).
Response to Arguments
Applicant's arguments filed March 2, 2026 have been fully considered but they are not persuasive.
Applicant argues Henderson does not relate to a mold used to form a spacer, which mold is removed before using the spacer for temporarily replacing the joint and the feature of the spacer is no longer only recited in the preamble and positively recited feature of the claimed device.
Although the additional limitations defining “spacer” are in the body of the claim, the claim is directed to an apparatus, whereas the amended limitations are directed to a product (a spacer) formed from the apparatus. The limitations do not recite to any recited structure to the device, and fail to incorporate or integrate the limitations to the apparatus and add further structure. Therefore, the limitation “for producing a spacer” and “the spacer is a temporary placeholder for an interim phase in the context of two-stage revisions septic replacement operations for endoprostheses for hip and shoulder total articular endoprostheses” recites a manner of operating the device for an intended use. 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. See MPEP § 2114 (II).
As Smith discloses that the cement mold is to form a temporary femoral hip implant or prosthesis (c. 4, L 21-25), the cement mold is capable of performing the intended use of “for producing a spacer” and “the spacer is a temporary placeholder for an interim phase in the context of two-stage revisions septic replacement operations for endoprostheses for hip and shoulder total articular endoprostheses.” The limitation does not add further structure to the claimed apparatus and thus because the cement mold in Smith is capable of performing the intended use, it meets the limitations as claimed.
Smith discloses a cement mold 10 (c. 4, L 21) comprising of articulating head portion 18, stem portion 22, and enlarged neck portion 20 (c. 4, L 40-42) where bone cement is pumped into the cement mold (c. 6, L 4-7), wherein bone cement may be a poly-methyl-methacrylate (PMMA) cement (c. 5, L 53-54). Henderson discloses a forming a hip prosthesis including a femoral component 26 (a stem) and a femoral head component 28, where the femoral head component 28 includes deflated balloon 28a, which when inflated with a molding, for example bone cement (polymethylmethacrylate), would take the form of hip hemiarthroplasty component 28b (c. 6, L 50-56, Fig. 8).
In response to applicant's argument that Henderson is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Henderson teaches advantage of a femoral head component inflated with bone cement, is in the field of joint replacement, and fulfills custom fitting and for making a variety of body part shapes mentioned in Smith
Smith discloses cement molds will be supplied in an array of sizes to meet various patient’s needs (c.5, L 66-67). Although Henderson discloses the product is for use in-situ, Henderson provides a way to achieve patrial expanding of a region of the implant and for making a variety of body part shapes through the femoral head component 28 includes deflated balloon 28a, which when inflated with a molding, for example bone cement (polymethylmethacrylate), would take the form of hip hemiarthroplasty component 28b (c. 6, L 50-56, Fig. 8). Therefore, the teaching of forming a hip prosthesis in Henderson would be applicable to the mold forming a temporary femoral hip implant or prosthesis in Smith and are applicable to the field of endeavor of the claimed subject matter.
Therefore, the argument is not persuasive.
In response to applicant's argument that one skilled in the art would not have applied Henderson as it teaches forming a permanent implant and not a spacer for temporarily replacing a joint, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues Ziran does not teach that the neck is entirely formed in the stem mold.
The argument is addressed in the updated 35 U.S.C. 103 rejection over Smith in view of Henderson.
Conclusion
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/JONATHAN B WOO/Examiner, Art Unit 1754
/SEYED MASOUD MALEKZADEH/Primary Examiner, Art Unit 1754
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