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 .
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.
Claim(s) 1, 2, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 6,292,678 (“Hall”).
Regarding Claim 1, Hall discloses a magnetically controllable (Abstract) medical device (120) for interventional procedures, the magnetically controllable medical device comprising:
a first segment operable to be magnetized with a first magnetization comprising a magnetic orientation, strength, and magnetization orientation (e.g. 124’; see Fig. 11A); and
a second segment operable to be magnetized with a second magnetization comprising a magnetic orientation, strength, and magnetization orientation (e.g. 124”’ see Fig. 11A),
wherein the first magnetization and the second magnetization are established as permanent magnetizations after the magnetically controllable medical device is manufactured.
Firstly, it is noted that that phrase “operable to be magnetized” implies a state which is not concerned with whether or not the magnets have actually been magnetized, whereby the device of Hall could have the magnetic field of its magnetized elements altered via various processes. Here the claim is directed toward an intermediate article and the instant method limitations are directed toward process steps required to form a finalized structure which is not positively claimed (nor are the method steps positively claimed). Secondly, Examiner notes that the method by which a device is formed is not germane to the patentability of the device itself to the extent that the same resultant structure can be produced by the claimed method, but also other conventional processes. Here, while Hall is silent as to when the permanent magnets are magnetized, the same resultant end structure of Hall can be produced irrespective of whether the magnetic elements are magnetized prior to assembly or after assembly.
Regarding Claim 2, in the instant case, as discussed above, the instant claims are not actually concerned with whether or not the magnetizable elements actually are provided in a magnetized state. However, it is noted that in configurations described by Hall (e.g. Fig.11A) the first magnetization is different from the second magnetization (see Fig. 11A – note the directionality of the poles of 124’ vs. 124”).
Regarding Claim 5, Hall discloses that the magnetically controllable medical device comprises one of a wire, guidewire, catheter, radio-frequency wire, micro-catheter, braid, coil, lumen, thrombectomy system, stent, aspiration tool, drug-delivery tool, aneurysm-filling coil, electrical lead, or embolization system (e.g. an “electrophysiology catheter” in particular).
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.
Claim(s) 3-4 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,292,678 (“Hall”) as applied above, and further in view of U.S. Publication No. 2008/0039830 (“Munger”).
Regarding Claims 3-4 and 6-7, Hall discloses the invention substantially as claimed except that the magnetic segments are made of platinum or palladium alloys, rather Hall only suggests a neodymium-iron-boron magnetic material. However, Munger discloses that one alternative to neodymium-iron-boron magnets is platinum-cobalt alloys (Par. 37). It would have been obvious for one having ordinary skill in the art at the time the invention was made to form the magnets of Hall of a platinum-cobalt alloy, as disclosed by Munger, as Munger discloses the two materials to be alternatives to one another and wherein it has been held that simple substitution of known equivalents is obvious when only predictable and expected outcomes are to be obtained, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), and that selection of a known material based upon its art recognized suitability for a particular purpose is likewise obvious, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,292,678 (“Hall”) as applied above, and further in view of U.S. Publication No. 2010/0069733 (“Kastelein”).
Regarding Claim 8, Hall discloses the invention substantially as claimed except that that the catheter has an outer diameter “less than 2mm”. Hall is silent as to the dimensions of the catheter system. However, it has been held that mere changes in size and proportion are not differences which are significant enough to sustain patentability when only predictable and expected results are to be obtained, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Specifically, in catheter systems it is known to vary the size and proportion of the catheter in order to adapt it to a specific patient’s physiology for a particular interventional procedure. Here the prior art, see Kastelein, discloses that electrophysiology catheters may have outer diameters “between about 1.5mm and about 3.5mm” (Par. 30), a range which overlaps with Applicant’s instantly claimed range (re: about 1.5mm to 2mm). It has been held that ranges which overlap with one another establish prima facie obviousness. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the catheter of Hall to have an outer diameter less than 2mm (specifically within the range of about 1.5mm to less than 2mm), as disclosed by Kastelein, in order to adapt the catheter to a specific patient’s physiology in order to perform a particular interventional procedure.
Claim(s) 9, 12, 16, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,292,678 (“Hall”) in view of U.S. Patent No. 6,980,843 (“Eng”).
Regarding Claim 9, Hall discloses a magnetically controllable medical device (120) for interventional medical procedures, the magnetically controllable medical device comprising:
a first permanent magnetic segment (124’); and
a second permanent magnetic segment (124”), wherein the first permanent magnetic segment has a different magnetic orientations and magnetization angles (see Fig. 11A).
Hall discloses the invention substantially as claimed except that that the different segments have different magnetic field strengths/magnitudes. However, Eng discloses that in such magnetic navigation systems it is known to vary not only the orientation and angle of the magnetic members, but also their relative strengths in order to assist in creating dissimilar magnetic properties between members to permit controlled positioning of the magnetic elements under an applied field (Col. 1, Ln. 53 – Col. 2, Ln. 2). It would have been obvious for one having ordinary skill in the art at the time the invention was made to alter the magnetic strength of the segments of Hall, as disclosed by Eng, in order to allow for more precise control over the bending shape of the device under an applied magnetic field.
Regarding Claim 12, Hall discloses that the magnetically controllable medical device comprises one of a wire, guidewire, catheter, radio-frequency wire, micro-catheter, braid, coil, lumen, thrombectomy system, stent, aspiration tool, drug-delivery tool, aneurysm-filling coil, electrical lead, or embolization system (e.g. an “electrophysiology catheter” in particular).
Regarding Claim 16, Hall discloses the invention substantially as claimed except that that the magnetic segments are established as permanent magnets after the magnetically controllable medical device is manufactured. However, Examiner notes that the method by which an article is formed is not germane to the patentability of the article itself to the extent that the end product is the same. Here, the device of Hall will create the same exact structure irrespective of whether the magnetic segments are magnetized before, during, or after manufacture.
Regarding Claim 17, Hall discloses a magnetically controllable medical device (120) for interventional medical procedures having magnetic material in which permanent magnetization has been established, and wherein the magnetic material includes one of a platinum alloy or a palladium alloy, wherein the magnetically controllable medical device is one of a wire, guidewire, catheter, radio-frequency wire, micro-catheter, braid, coil, lumen, thrombectomy system, stent, aspiration tool, drug-delivery tool, aneurysm-filling coil, electrical lead, and embolization system, wherein establishing permanent magnetization creating individual segments (124’, 124”) having different magnetic orientations and magnetization angles (see Fig. 11A; see Summary of Invention).
Hall discloses the invention substantially as claimed except that that the different segments have different magnetic field strengths/magnitudes. However, Eng discloses that in such magnetic navigation systems it is known to vary not only the orientation and angle of the magnetic members, but also their relative strengths in order to assist in creating dissimilar magnetic properties between members to permit controlled positioning of the magnetic elements under an applied field (Col. 1, Ln. 53 – Col. 2, Ln. 2). It would have been obvious for one having ordinary skill in the art at the time the invention was made to alter the magnetic strength of the segments of Hall, as disclosed by Eng, in order to allow for more precise control over the bending shape of the device under an applied magnetic field.
In the instant case Hall fails to explicitly disclose HOW the segments are magnetized. However, it is noted that the method by which an article of manufacture is formed is not germane to the patentability of the article itself when the end product is identical. Here the catheter of Hall will present with an end structure (120) which is identical irrespective as to whether it is magnetized via a magnetic array or magnetized by other means before, during, or after assembly.
Regarding Claim 20, Hall discloses the invention substantially as claimed except that that the magnetic segments are established as permanent magnets after the magnetically controllable medical device is manufactured. However, Examiner notes that the method by which an article is formed is not germane to the patentability of the article itself to the extent that the end product is the same. Here, the device of Hall will create the same exact structure irrespective of whether the magnetic segments are magnetized before, during, or after manufacture.
Claim(s) 10-11, 13-14, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,292,678 (“Hall”) in view of U.S. Patent No. 6,980,843 (“Eng”) as applied above, and further in view of U.S. Publication No. 2008/0039830 (“Munger”).
Regarding Claims 10-11, 13-14, and 18-19, Hall discloses the invention substantially as claimed except that the magnetic segments are made of platinum or palladium alloys, rather Hall only suggests a neodymium-iron-boron magnetic material. However, Munger discloses that one alternative to neodymium-iron-boron magnets is platinum-cobalt alloys (Par. 37). It would have been obvious for one having ordinary skill in the art at the time the invention was made to form the magnets of Hall of a platinum-cobalt alloy, as disclosed by Munger, as Munger discloses the two materials to be alternatives to one another and wherein it has been held that simple substitution of known equivalents is obvious when only predictable and expected outcomes are to be obtained, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), and that selection of a known material based upon its art recognized suitability for a particular purpose is likewise obvious, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,292,678 (“Hall”) in view of U.S. Patent No. 6,980,843 (“Eng”) as applied above, and further in view of U.S. Publication No. 2010/0069733 (“Kastelein”).
Regarding Claim 15, Hall discloses the invention substantially as claimed except that that the catheter has an outer diameter “less than 2mm”. Hall is silent as to the dimensions of the catheter system. However, it has been held that mere changes in size and proportion are not differences which are significant enough to sustain patentability when only predictable and expected results are to be obtained, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Specifically, in catheter systems it is known to vary the size and proportion of the catheter in order to adapt it to a specific patient’s physiology for a particular interventional procedure. Here the prior art, see Kastelein, discloses that electrophysiology catheters may have outer diameters “between about 1.5mm and about 3.5mm” (Par. 30), a range which overlaps with Applicant’s instantly claimed range (re: about 1.5mm to 2mm). It has been held that ranges which overlap with one another establish prima facie obviousness. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the catheter of Hall to have an outer diameter less than 2mm (specifically within the range of about 1.5mm to less than 2mm), as disclosed by Kastelein, in order to adapt the catheter to a specific patient’s physiology in order to perform a particular interventional procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 07/14/2026
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