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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on December 15, 2025 is acknowledged.
Claims 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 15, 2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Golovko et al., “Manufacturing of small diameter magnesium tubes with the hot extrusion and drawing process”, Tube Ukraine 2007 International Conference, 2007, pp. 263-274, hereinafter “Golovko”.
Regarding claim 1, Golovko discloses a method for producing a tubular semi-finished product for a scaffold on an implant, wherein the semi-finished product consists of a magnesium alloy and/or a zinc alloy (see the abstract), said method comprising:
extruding a tubular semi-finished product in a heated die or tempering an extruded tubular semi-finished product in a heating device (section “2. Extrusion process” discloses a MgCa-alloy billet was extruded in the extrusion tool illustrated in Fig. 1 heated within the range of 340°C to 420°C during testing as shown in Fig. 6),
applying a tensile stress and/or a torsional stress to the tubular semi-finished product or the extruded tubular semi-finished product by a tube drawing device (section “3. Drawing process” discloses the extruded tube was then drawn in a chain drawing bench), the tube drawing device comprising a clamping device, the clamping device being fixed on a predefined portion of the tubular semi-finished product or extruded tubular semi-finished product (section “3.1 Experimental methods” discloses drawing dies were used to clamp the extruded tube during drawing), wherein tensile force and/or torsion moment generated by the tube drawing device transfers to the tubular semi-finished product or the extruded tubular semi-finished product(section “3.2 Results” discloses tensile force generated by the drawing device transferred to the extruded tube which changed the structure of the tube material as shown in Fig. 10).
Regarding claim 2, Golovko anticipates the method according to claim 1 as explained above. Golovko further discloses the die applies heat to material of the semi-finished product in a range between 200°C and 450°C. Fig. 6 of Golovko shows testing was carried out within the temperature range of 340°C to 420°C.
Regarding claim 6, Golovko discloses a device for producing a tubular semi-finished product for a scaffold of an implant for use with a heated die or heating device (the laboratory chain drawing bench disclosed in section 3.1), the device comprising a clamping device configured to apply a tensile stress and/or a torsional stress in the material of the semi-finished product exiting from the die or the heating device (section 3.1 discloses drawing dies were used to clamp the magnesium tube which exited the extrusion die shown in Fig. 1), wherein the clamping device is configured to be fixed on a predefined portion of the tubular semi-finished product (the drawing dies clamp the product on a predefined portion).
Regarding claim 9, Golovko anticipates the device according to claim 6 as explained above. Golovko further discloses wherein the system according to claim 6 comprises:
an extrusion device with a heated die for extruding the tubular semi-finished product (section 2.1 discloses the extrusion tooling was heated to correspond to the billet temperature) or
a heating device for tempering an extruded tubular semi-finished product. Section 3.1 of Golovko discloses four heating cartridges were used to temper the extruded tube during drawing.
Regarding claim 10, Golovko anticipates the system according to claim 9 as explained above. Golovko further discloses the heated die is configured to apply a temperature between 200°C and 450°C. Section 2.1 discloses the extrusion tooling was heated to correspond to the billet temperature of between 340°C to 420°C to maintain the temperature of the billet as it was extruded.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 3-4, 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Golovko in view of Chinese Patent Publication No. CN 112718900 A by Zhang et al., hereinafter “Zhang”.
Regarding claim 3, Golovko anticipates the method of claim 1 as explained above. However, Golovko does not disclose the heating device applies heat to the extruded tubular semi-finished product in a range between 180°C and 270°C. Section “3.1 Experimental methods” of Golovko discloses heating within the range of 320 to 410°C.
In the same field of drawing magnesium alloy tubes, Zhang teaches it was known before the effective filing date of the claimed invention to heat magnesium alloy tubes above 225°C during tube-drawing of magnesium alloy tubes. See paragraph [n0003].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the teaching of Zhang to the method disclosed by Golovko by adjusting the temperature range used in Golovko’s method to include temperatures above 225°C as Zhang teaches, thus extending Golovko’s temperature range to include 225 to 270°C which overlaps with the range claimed in claim 3. A person of ordinary skill would have recognized extending the temperature range of Golovko’s method to include temperatures above 225°C would achieve the predictable result of heating the magnesium tube within an increased range with the lower threshold of the range being defined by the magnesium crystal activation temperature as paragraph [n0003] of Zhang teaches.
Regarding claim 4, Golovko anticipates the method of claim 1 as explained above. However, Golovko is silent regarding details of the laboratory chain drawing bench disclosed in section 3.1 of Golovko. Therefore, Golovko does not expressly disclose a slide of the tube drawing device is movable on a guide, the clamping device is connected to the slide, and the slide applies the tensile stress.
In the same field of drawing magnesium alloy tubes, Zhang teaches an automatic drawing device and method for magnesium-based pipes. See title. The drawing device shown in Fig. 1 includes a slide (pulling trolley 10 in Fig. 1) movable on a guide (guide rail 2 in Fig. 1) which holds a clamping device (four-jaw chuck 4 in Fig. 1). Pulling trolley 10 applies tensile stress to the magnesium tube as servo motor 1 pulls trolley 10 from left to right via rotation of lead screw 3. See paragraph [n0027].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use Zhang’s tube-drawing device as the drawing device disclosed in Golovko’s method such that the drawing device used in Golovko’s method included a guide, clamping device and slide as claimed in claim 4. A person of ordinary skill would have recognized applying the teaching of Zhang to the method of Golovko would achieve the predictable result of Golovko’s method where a drawing device including a slide, guide and clamping device is used as Zhang teaches.
Regarding claim 7, Golovko anticipates the device according to claim 6 as explained above. However, Golovko is silent regarding details of the laboratory chain drawing bench disclosed in section 3.1. Therefore, Golovko does not expressly disclose a slide of the tube drawing device is movable on a guide, the clamping device is connected to the slide, and the slide applies the tensile stress.
In the same field of drawing magnesium alloy tubes, Zhang teaches an automatic drawing device and method for magnesium-based pipes. See title. The drawing device shown in Fig. 1 includes a slide (pulling trolley 10 in Fig. 1) movable on a guide (guide rail 2 in Fig. 1) which holds a clamping device (four-jaw chuck 4 in Fig. 1). Pulling trolley 10 applies tensile stress to the magnesium tube as servo motor 1 pulls trolley 10 from left to right via rotation of lead screw 3. See paragraph [n0027].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use Zhang’s tube-drawing device as the drawing device disclosed in Golovko’s method such that the drawing device disclosed by Golovko’s includes a guide, clamping device and slide as claimed in claim 7. A person of ordinary skill would have recognized applying the teaching of Zhang to the device disclosed by Golovko would achieve the predictable result of Golovko’s drawing device including a slide, guide and clamping device.
Regarding claim 11, Golovko anticipates the system according to claim 9 as explained above. However, Golovko does not disclose the heating device applies heat to the extruded tubular semi-finished product in a range between 180°C and 270°C. Section “3.1 Experimental methods” of Golovko discloses heating within the range of 320 to 410°C.
In the same field of drawing magnesium alloy tubes, Zhang teaches it was known before the effective filing date of the claimed invention to heat magnesium alloy tubes above 225°C during tube-drawing of magnesium alloy tubes. See paragraph [n0003].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the teaching of Zhang to the method disclosed by Golovko by adjusting the temperature range used in Golovko’s method to include temperatures above 225°C as Zhang teaches, thus extending Golovko’s temperature range to include 225 to 270°C which overlaps with the range claimed in claim 11. A person of ordinary skill would have recognized extending the temperature range of Golovko’s method to include temperatures above 225°C would achieve the predictable result of heating the magnesium tube within an increased range with the lower threshold of the range being defined by the magnesium crystal activation temperature as paragraph [n0003] of Zhang teaches.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Golovko in view of U.S. Patent No. 1,525,730 to Gates, hereinafter “Gates”.
Regarding claim 5, Golovko anticipates the method according to claim 1 as explained above. However, Golovko does not disclose a rotary head of the tube drawing device is rotatable about a longitudinal axis that runs parallel to a longitudinal axis of the tubular semi-finished product and the clamping device is connected to the rotary head.
In the same field of tube drawing devices, Gates teaches it was known before the effective filing date of the claimed invention to use a rotary head connected to the clamping device of a tube drawing device to apply torsional stress to the tube material which increases the strength of the tube. See Figs. 7 and 8 and the written description at page 2, line 48-111.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a rotary head into Golovko’s disclosed tube drawing machine to apply torsional stress to the tube material in the same way Gates teaches. A person of ordinary skill would have recognized applying the teaching of Gates to the method disclosed by Golovko would achieve the predictable result of adding capacity to apply torsional stress to the drawn tube to Golovko’s method.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Golovko in view of Zhang and further in view of Gates.
Regarding claim 8, the prior art reference combination of Golovko in view of Zhang renders the device according to claim 7 unpatentable as explained above. However, neither Golovko nor Zhang teach the device comprises a rotary head that is rotatable about a longitudinal axis, the rotary head being connected to the clamping device, wherein a longitudinal axis of the rotation of the rotary head runs parallel to a longitudinal axis of the tubular semi-finished product, and the rotary head is configured to apply the torsional stress.
In the same field of tube drawing devices, Gates teaches it was known before the effective filing date of the claimed invention to use a rotary head connected to the clamping device of a tube drawing device to apply torsional stress to the tube material which increases the strength of the tube. See Figs. 7 and 8 and the written description at page 2, line 48-111.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a rotary head into Zhang’s disclosed tube drawing machine is the same way Gates teaches. A person of ordinary skill would have recognized applying the teaching of Gates to the device of Zhang would achieve the predictable result of adding capacity to apply torsional stress to the drawn tube to the device.
Conclusion
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/P.D.P./ Examiner, Art Unit 3725
/Christopher L Templeton/Supervisory Patent Examiner, Art Unit 3725