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 .
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 .
Specification
The disclosure is objected to because of the following informalities:
The specification at p.3 lines 1-5 makes reference to numbered claims. These claim numbers are incorrect and subject to change. Reference to specific numbered claims should be deleted from the specification.
Appropriate correction is required.
Claim Objections
Claims 4 and 17 are objected to because of the following informalities:
At the end of claim 4, “exposure” should be corrected to –the exposure--.
At the end of claim 17, “exposure” should be corrected to –the exposure--.
Appropriate correction is required.
Claim Interpretation
No claim limitations are interpreted under 112(f).
Exposure and corrosion are interpreted according to the specification at p.3 lines 20-25.
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.
Claims 1-20 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 pre-AIA the applicant regards as the invention.
In claim 1 the last clause “an increasing exposure in the direction” is confusing due to antecedent basis. That is, “an increasing exposure” has already been introduced, whereas “the direction” has not. For the purpose of examination, the limitation has been interpreted as and may be corrected to --the increasing exposure in a direction--.
Claim 3 recites “comprising a plurality of laser beam surface treatments.” It is not clear whether this is the same treatment from claim 1, or an additional plurality. For the purpose of examination, the limitation has been interpreted as and may be corrected to --wherein the at least one laser beam surface treatment comprises a plurality of laser beam surface treatments--.
preferably*
Claim 6 recites “the laser source.” There is insufficient antecedent basis for this limitation in the claim, rendering the claim indefinite.
Claim 7 recites “the laser source.” There is insufficient antecedent basis for this limitation in the claim, rendering the claim indefinite.
Claim 7 recites “generate laser beam radiation.” It is not clear whether this is related to any other claim limitations, such as “laser beam surface treatment’ of claim 1. Claim 7 may be corrected by rewriting it similar to claim 5.
Claim 8 recites “the laser source used” There is insufficient antecedent basis for this limitation in the claim, rendering the claim indefinite.
In claim 9, “the laser source used” should be corrected to “the laser source” to maintain consistent wording and avoid confusion. Specifically, it is unclear how the laser source must be used because there is no previous limitation reciting steps for “use” of a laser source.
Claim 16 recites “comprising a plurality of laser beam surface treatments.” It is not clear whether this is the same treatment from claim 1, or an additional plurality. For the purpose of examination, the limitation has been interpreted as and may be corrected to --wherein the at least one laser beam surface treatment comprises a plurality of laser beam surface treatments--.
In claim 18, “the laser source used” should be corrected to “the laser source” to maintain consistent wording and avoid confusion. Specifically, it is unclear how the laser source must be used because there is no previous limitation reciting steps for “use” of a laser source.
In claim 19, “the laser source used” should be corrected to “the laser source” to maintain consistent wording and avoid confusion. Specifically, it is unclear how the laser source must be used because there is no previous limitation reciting steps for “use” of a laser source.
In claim 20, “the laser source used” should be corrected to “the laser source” to maintain consistent wording and avoid confusion. Specifically, it is unclear how the laser source must be used because there is no previous limitation reciting steps for “use” of a laser source.
The remaining rejected claims are rejected for their dependence on an indefinite claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 14, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guo (US 2014/0050942).
Regarding claim 1, Guo discloses:
A method for the controlled guidance of corrosion on a material or article to be treated comprising the following steps:
- providing a guidance strategy for guiding corrosion on the material or article to be treated, said guidance strategy for guiding corrosion comprising a map with guidance directions for guiding corrosion (¶54 “the location and orientation of the fracture and later fracture treatment may require the surface of the implant to be processed at one or more speeds such the biodegradable medical device corrodes differently at one or more locations or in one or more desired directions.”);
- establishing at least one laser beam surface treatment (¶39 “laser shock peening”) to be applied on the material or article to be treated by means of an increasing exposure (¶39 “The biodegradable medical device properties can be adjusted by tuning the processing conditions used in the surface treatment including … laser power… focal length.” ¶53, “The speed refers to the velocity of the tool used in processing the biodegradable medical device.” ¶54 “The speed can adjust the corrosion rate of the biodegradable medical device.”), providing at least two speeds of corrosion in the material or article to be treated (¶53 “the speed can be adjusted from 50 millimeters per minute to 900 millimeters per minute (e.g., from 100 millimeters per minute to 800 millimeters per minute, from 300 millimeters per minute to 600 millimeters per minute)”);
- applying said at least one laser beam surface treatment on at least one area of the material or article to be treated with an increasing exposure in the direction indicated by the aforementioned map with guidance directions (¶54 “the location and orientation of the fracture and later fracture treatment may require the surface of the implant to be processed at one or more speeds such the biodegradable medical device corrodes differently at one or more locations or in one or more desired directions.”).
Regarding claim 2, Guo discloses:
the increasing exposure corresponds to the formula
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wherein P is the power of the laser, and v is the processing speed (¶53-¶54 discloses that a change in speed changes the degradation/corrosion rate).
Regarding claims 3 and 16, Guo discloses:
a plurality of laser beam surface treatments performed with an increase in the exposure in defined stages (¶53 different speeds, ¶54 “The speed can adjust the corrosion rate of the biodegradable medical device.”).
Regarding claim 14, Guo discloses:
the material or article to be treated is a metallic (¶30-¶33 magnesium or magnesium alloy) osteosynthesis plate, and the method produces a metallic osteosynthesis plate (¶36 “orthopedic plates… intraosseous devices,” ¶49 “plate aligned along the femur,” ¶5 “Implants and bone form a composite structure”) that can be reabsorbed by the human body (¶34).
Regarding claims 4 and 17, Guo discloses:
the at least one surface treatment is performed by means of a gradual increase in exposure (¶50 “establishing a gradient of the previously mentioned surface integrity properties. A gradient can be achieved in a specific location by varying the contact pressure while moving either the biodegradable medical device or tooling.” see ¶39, ¶51).
Claims 1 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prevey (US 20070266754).
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Regarding claim 1, Prevey discloses:
A method for the controlled guidance of corrosion (¶47 “The protected surface 146 is thereby cathodically protected from corrosive attack while the sacrificial areas 150 preferentially corrode”) on a material or article to be treated comprising the following steps:
- providing a guidance strategy for guiding corrosion on the material or article to be treated, said guidance strategy for guiding corrosion comprising a map with guidance directions for guiding corrosion (high corrosion at 150, low corrosion at 146, ¶45-¶50);
- establishing at least one laser beam surface treatment to be applied on the material or article to be treated by means of an increasing exposure, providing at least two speeds of corrosion in the material or article to be treated (¶49 treated by laser at 146, and treated by laser at 150, see ¶15, untreated at other areas. ¶46 states “The second surface treatment induces a specified level of cold work in the sacrificial areas 150 such that the level of cold work induced by the second surface treatment is greater than the level of cold work induced by the first surface treatment at the protected surface 146 of the lug structure 140.”);
- applying said at least one laser beam surface treatment on at least one area of the material or article to be treated with an increasing exposure in the direction indicated by the aforementioned map with guidance directions (146 is treated, other areas are untreated).
Regarding claim 15, Prevey discloses:
the material or article to be treated is an anode for the cathodic protection of steel reinforcements in constructions made of concrete, and the method produces an anode for the cathodic protection of steel reinforcements in constructions made of concrete with guided and controlled corrosion, having a prolonged duration and protection (The claim recites an intended use for the article produced by the method. The metallic article of Prevey is capable of use as an anode because it is metal and it is capable of being electrically connected see Fig 4, ¶26.).
Claims 1 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yan (US 2006/0229711).
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Regarding claim 1, Yan discloses:
A method for the controlled guidance of corrosion on a material or article to be treated comprising the following steps:
- providing a guidance strategy for guiding corrosion on the material or article to be treated, said guidance strategy for guiding corrosion comprising a map with guidance directions for guiding corrosion (corrosion is initiated at corrosion inducing features 30, which have a particular shape and/or pattern, see Figs 14-17, ¶77, ¶79);
- establishing at least one laser beam surface treatment (¶85, “laser etching”) to be applied on the material or article to be treated by means of an increasing exposure, providing at least two speeds of corrosion in the material or article to be treated (treated and untreated);
- applying said at least one laser beam surface treatment on at least one area of the material or article to be treated with an increasing exposure in the direction indicated by the aforementioned map with guidance directions (the treated areas 30 have been exposed and the untreated areas have not).
Regarding claim 14, Yan discloses:
the material or article to be treated is a metallic (¶153 “pure tungsten metal,” ¶161, see claims 2-3) osteosynthesis plate, and the method produces a metallic osteosynthesis plate (¶53 “bone plates”) that can be reabsorbed by the human body (¶153 “The bone plate starts to dissolve its mass into adjacent tissue over a period of time.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5-9 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Guo (US 2014/0050942) in view of Sealy (Characterization and Modification of Surface Topography by Sequential Laser Peening Biodegradable Magnesium-Calcium Alloy).
Regarding claim 5, Guo does not teach:
n the step of establishing at least one laser beam surface treatment on the material or article to be treated, said laser beam comes from a laser source the wavelength of which is within the range of 100 nm to 11000 nm.
Guo is silent on the particulars of the laser.
Sealy, in a joint publication with Guo, teaches a method of using a laser to improve the corrosion resistance of calcium-magnesium implants. The laser is a Nd:YAG laser with a wavelength of 1064 nm, a pulse width of 5-7 ns, a frequency of 30 Hz, and a power of 3W or 8W (p.1 Micro Dent Fabrication section, p.2 ¶2).
COMBINATION
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Guo by using the particulars of the laser of Seal because Sealy teaches that the laser is appropriate for laser shock peening a medical implant for corrosion resistance.
Regarding claim 6, Guo as modified by the laser of Sealy teaches:
the mean power of the laser source is within the range of 1 W to 5000 W (Sealy 3W or 8W, p.2 ¶2).
Regarding claim 7, Guo as modified by the laser of Sealy teaches:
the laser source used to generate laser beam radiation is selected from Nd:YAG (Sealy p.1 Micro Dent Fabrication section )…[alternative limitations].
Regarding claim 8, Guo as modified by the laser of Sealy teaches:
the laser source used emits radiation in pulsed or continuous mode (Sealy p.1 Micro Dent Fabrication section “pulse width”).
Regarding claim 9, Guo as modified by the laser of Sealy teaches:
the laser source used emits in pulsed mode with a pulse duration between milliseconds and femtoseconds and more favorably in the range of 1 to 500 nanoseconds (Sealy p.1 Micro Dent Fabrication section “pulse width (τ) = 5-7 ns”).
Regarding claims 18-20, Guo as modified by the laser of Sealy teaches:
the laser source used emits in pulsed mode with a pulse duration between milliseconds and femtoseconds and more favorably in the range of 1 to 500 nanoseconds (Sealy p.1 Micro Dent Fabrication section “pulse width (τ) = 5-7 ns”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Prevey (US 2007/0266754) in view of Mangiarino (US 2002/0104834).
Regarding claim 10, Prevey discloses:
the material or article to be treated has a non-planar shape (at 146)…
Prevey does not explicitly disclose:
and the laser beam scans the surface of the material or article to be treated by means of a three-dimensional optical scanning system.
Prevey discloses a non-planar surface 146 that is treated by laser shock peening, but does not provide details of the laser treatment apparatus.
Mangiarino teaches a device for directing a laser beam across varied surface, including “vertical surface or surfaces which are however spatially oriented” (¶11). The device is a three-dimensional optical scanner including a movable focusing lens and an adjustable mirror (¶19, ¶22). The device is capable of guiding the laser through a large working volume (¶25).
COMBINATION
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Prevey to have the laser move across the surface to treat the surface by a three-dimensional optical scanning system including a movable lens and mirror, as taught by Mangiarino, because Mangiarino teaches that this is an appropriate way to treat various parts of a vertical non-planar surface.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Prevey (US 2007/0266754) in view of Strom (US 4,835,361).
Regarding claim 11, Prevey discloses:
the material or article to be treated has a planar shape (at 150)…
Prevey does not explicitly disclose:
and the laser beam scans the surface of the material or article to be treated by means of a two-dimensional optical scanning system.
Prevey discloses a planar surface 150 that is treated by laser shock peening, but does not provide details of the laser treatment apparatus.
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Strom teaches:
a laser machining system in which “the beam is delivered to a mirror 14 which is pushed and pulled to move the beam along axes parallel to the x and y axes” to machine the various parts of a planar surface of a component (col 3 lines 29-36). Because this works by manipulating the beam with an optical component, i.e., a mirror, rather than physically aiming the laser source, it is understood to meet the limitation “optical scanning system.”
COMBINATION
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Prevey to have the laser move across the surface to treat the surface by a two-dimensional optical scanning system including a movable mirror, as taught by Strom, because Strom teaches that this is an appropriate way to treat various parts of a planar surface.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yan (US 2006/0229711) in view of Itakura US 2021/0145553 A1).
Regarding claim 12, Yan does not disclose:
the method is carried out in a vacuum or in the presence of an oxidizing gas atmosphere.
Yan is silent on the atmosphere used in laser processing, but does disclose that the device may purposefully be substantially oxidized before implantation (¶71). A laser is used to form corrosion inducing features (¶85).
Itakura teaches a method for manufacturing a medical implant. The implant is irradiated with a laser. Oxygen gas may be selected to promote oxidation of the surface (¶84-¶85).
COMBINATION
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yan by performing laser treatment in an oxygen atmosphere, as taught by Itakura, to obtain the benefit of promoting the formation of oxidation corrosion on the surface of the implant to meet the design requirements of having a specified amount of oxidation before implantation.
Regarding claim 13, Yan as modified by the oxygen of Itakura teaches:
the oxidizing gas is 02, CO2, or mixtures thereof (oxygen, as taught by Itakura).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Regarding claim 1, Martens (US 2018/0097325) discloses:
A method for the controlled guidance of corrosion (¶12 “outer defects in the array are experiencing greater corrosion, thereby effectively shielding the inner defects in the array”) on a material or article to be treated comprising the following steps:
- providing a guidance strategy (¶16 “determining proper or optimized placement of the induced defects relative to one another and relative to the area to be protected”) for guiding corrosion on the material or article to be treated, said guidance strategy for guiding corrosion comprising a map with guidance directions for guiding corrosion (¶12 “outer defects in the array are experiencing greater corrosion, thereby effectively shielding the inner defects in the array,” ¶17 “Induced defects 20 and/or outer channel 24 provide sacrificial corrosion protection for active contact region 12 and lead-in region 14 by scavenging corrosive gases present in an operating environment for metal component 10.” ¶16 “preferential corrosion of the outermost induced defects”);
- establishing at least one laser beam surface treatment (¶18 “lasers and other materials processing systems and methods may be used to create induced defects 20”) to be applied on the material or article to be treated by means of an increasing exposure, providing at least two speeds of corrosion in the material or article to be treated (treated or untreated);
- applying said at least one laser beam surface treatment on at least one area of the material or article to be treated with an increasing exposure in the direction indicated by the aforementioned map with guidance directions (treated surfaces have greater exposure, untreated surfaces have no exposure).
Regarding claim 2, Martens discloses:
the increasing exposure corresponds to the formula
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wherein P is the power of the laser, and v is the processing speed (the treated area has a higher power than the untreated area).
Regarding claim 3, Martens discloses:
a plurality of laser beam surface treatments performed with an increase in the exposure in defined stages, preferably two stages (The two stages are treated and untreated. This is consistent with the instant specification at p.4.),
Bi (CN 108525022)
Regarding claim 1, Bi discloses:
A method for the controlled guidance of corrosion (¶16 “The outer and side surfaces of the hemostatic clip have a laser-modified layer after laser surface modification, which has a faster degradation rate than the inner surface, and can achieve directional degradation from the outside to the inside.”) on a material or article to be treated comprising the following steps:
- providing a guidance strategy for guiding corrosion on the material or article to be treated, said guidance strategy for guiding corrosion comprising a map with guidance directions for guiding corrosion (¶16 “The outer and side surfaces of the hemostatic clip have a laser-modified layer after laser surface modification, which has a faster degradation rate than the inner surface, and can achieve directional degradation from the outside to the inside.”);
- establishing at least one laser beam surface treatment (¶25 “Use a laser to perform laser surface modification on the outer surface and two sides of the prepared hemostatic clip.”) to be applied on the material or article to be treated by means of an increasing exposure, providing at least two speeds of corrosion in the material or article to be treated (treated is faster, untreated is slower);
- applying said at least one laser beam surface treatment on at least one area of the material or article to be treated with an increasing exposure in the direction indicated by the aforementioned map with guidance directions (¶44 “perform laser surface modification on the outer surface and two sides of the prepared hemostatic clip”).
Regarding claim 6, Bi discloses:
the mean power of the laser source is within the range of 1 W to 5000 W (¶17 “5-15W”).
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Regarding claim 1, Srinivasan (US 2017/0240985) discloses:
A method for the controlled guidance of corrosion on a material or article to be treated comprising the following steps:
- providing a guidance strategy for guiding corrosion on the material or article to be treated, said guidance strategy for guiding corrosion comprising a map with guidance directions for guiding corrosion (reduce corrosion on leading edge, ¶81, see Fig 5, ¶2, ¶3);
- establishing at least one laser beam surface treatment to be applied on the material or article to be treated by means of an increasing exposure (¶35 laser etching to produce hydrophobic surface), providing at least two speeds of corrosion in the material or article to be treated (untreated blade surface and treated blade surface);
- applying said at least one laser beam surface treatment on at least one area of the material or article to be treated with an increasing exposure in the direction indicated by the aforementioned map with guidance directions (the leading edge is treated and the remainder of the blade is untreated, ¶88).
Northrop (US 2009/0043228) discloses laser shock peening a medical device to induce compressive residual stresses. “Corrosion resistance and wear resistance can also be achieved using a laser shock peening process” (¶42). A medical device may have “two or more different regions of compressive residual stress that are at a different magnitude from one another. For example, as shown in FIG. 23, the member 2530 can include a first region of compressive residual stresses 2547 having a first magnitude of compressive residual stress that may include portions or substantially the entire length of member 2530 having slots 2535. A second region of compressive residual stresses 2548 having a second magnitude of compressive residual stresses may be located at and include one or more, or all of the beams 2536” (¶87).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOPAZ L ELLIOTT whose telephone number is (571)270-5851. The examiner can normally be reached Monday-Friday 9 a.m. - 4 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ibrahime Abraham can be reached on (571) 270-5569. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOPAZ L. ELLIOTT/Primary Examiner, Art Unit 3761
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