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, 5, 6, 9 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170347914 A1 to Issacson et al. (hereinafter, Issacson).
Regarding Claim 1, Issacson discloses a medical device comprising inter alia:
a magnetized member comprising at least one magnetized portion containing magnetized martensitic stainless steel (para. [0045] “…a needle 620 having a cannula 622 defining an elongate shaft 626 having a proximal end 621 and a distal tip 623…”) (para. [0044] “Multiple magnetic regions enable the invasive medical device to be encoded with multiple magnetic signatures…”) (para. [0054] “The magnetic regions according to any of the embodiments described above can be… martensitic…”), wherein:
the medical device has an elongated outer shape with a distal end side configured to be inserted inside a body (para. [0053] “… the plurality of magnetic regions can be used for visualization of the device during an insertion procedure…”) (distal tip 623 is capable of being inserted inside a body), and the magnetized member is provided in a portion of the distal end side of the medical device (magnetic regions 630, 631 and 632 are located in a portion of the distal end side of the medical device, see FIG. 13).
Regarding Claim 2, Issacson discloses the medical device according to claim 1, wherein: the magnetized member is a core shaft, and the magnetized portion is provided in a distal end portion of the core shaft (para. [0045] “…the magnetic regions can be provided by cold working the shaft 626 of the needle 620, or modifying the composition of the needle 620 to increase the strength of the magnetic fields B1, B2, and B3.”).
Regarding Claim 5, Issacson discloses the medical device according to claim 1, wherein: the at least one magnetized portion comprises a plurality of magnetized portions, and the plurality of magnetized portions are spaced apart from each other in an axial direction of the medical device (para. [0045] “…a distance d1 and d2 between the magnetic regions 630, 631 and 631…”).
Regarding Claim 6, Issacson discloses the medical device according to claim 2, wherein: the at least one magnetized portion comprises a plurality of magnetized portions, and the plurality of magnetized portions are spaced apart from each other in an axial direction of the medical device (para. [0045] “…a distance d1 and d2 between the magnetic regions 630, 631 and 631…”).
Regarding Claim 9, Issacson discloses the medical device according to claim 5, wherein at least two magnetized portions among the plurality of magnetized portions have lines of magnetic force extending in different directions from each other (para. [0045] “Thus, while magnetic regions 630, 631 and 632 are shown as having pole orientations of +/−, +/− and +/−, these pole orientations can be varied in any number of ways such as +/−, −/+ and +/−, or alternatively, −/+, +/− and −/+. Thus, by changing pole orientation of the magnetic regions, another variable of the magnetic regions can be utilized to provide another way to encode needle information.”) (see different directions indicated by arrows in FIG. 13).
Regarding Claim 10, Issacson discloses the medical device according to claim 6, wherein at least two magnetized portions among the plurality of magnetized portions have lines of magnetic force extending in different directions from each other (para. [0045] “Thus, while magnetic regions 630, 631 and 632 are shown as having pole orientations of +/−, +/− and +/−, these pole orientations can be varied in any number of ways such as +/−, −/+ and +/−, or alternatively, −/+, +/− and −/+. Thus, by changing pole orientation of the magnetic regions, another variable of the magnetic regions can be utilized to provide another way to encode needle information.”) see different directions indicated by arrows in FIG. 13).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3, 4, 7, 8, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Issacson in view of US 20030093011 A1 to Jalisi.
Issacson discloses (Claims 7 and 8) wherein the at least one magnetized portion comprises a plurality of magnetized portions, and the plurality of magnetized portions are spaced apart from each other in an axial direction of the medical device (para. [0045] “…a distance d1 and d2 between the magnetic regions 630, 631 and 631…”). And (Claims 11 and 12) wherein at least two magnetized portions among the plurality of magnetized portions have lines of magnetic force extending in different directions from each other (para. [0045] “Thus, while magnetic regions 630, 631 and 632 are shown as having pole orientations of +/−, +/− and +/−, these pole orientations can be varied in any number of ways such as +/−, −/+ and +/−, or alternatively, −/+, +/− and −/+. Thus, by changing pole orientation of the magnetic regions, another variable of the magnetic regions can be utilized to provide another way to encode needle information.”) see different directions indicated by arrows in FIG. 13).
Issacson discloses the claimed invention except for expressly disclosing (Claims 3 and 4) a coercive force layer covering at least a portion of a surface of the magnetized member, and containing a material with a higher coercive force than martensitic stainless steel, wherein the magnetized portion comprises the coercive force layer magnetized together with the magnetized member. However, Jalisi teaches a stainless-steel intraluminal device that has a performance enhancing coating such as platinum, applied at the distal end of the device (Abstract, paras. [0006], [0024]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the martensitic stainless steel of Issacson to include the platinum coating of Jalisi, as Jalisi teaches at para. [0024] that a platinum coating would have provided the device radiopacity and further teaches at para. [0006] that this would have allow visualization under fluoroscope allowing a surgeon to advance the device to a desired location.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791