DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 2, 5-7, 9-11 and 21-23 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.
Regarding Claim 1, the limitation “and containing a magnetic material…” renders the claim indefinite. It is unclear which claim limitation in Claim 1 “contains” the magnetic material (e.g., the medical device overall? The magnetized member? For purposes of examination the indefinite limitation has been deemed to claim “where the coercive for layer contains a magnetic material…”
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, 2, 5-7, 9-11 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170347914 A1 to Issacson et al. (hereinafter, Issacson) in view of US 20070016131 A1 to Munger et al. (hereinafter, Munger).
Regarding Claims 1 and 21, 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).
Issacson discloses the claimed invention except for expressly disclosing a coercive force layer covering at least a portion of a surface of the magnetized member, and containing a magnetic material with a high coercive force than martensitic stainless steel, where the coercive force layer is an alloy containing platinum as a main component and iron, niobium, or cobalt.
However, Munger teaches a magnetic elongate device such as a needle or catheter (para. [0008]-[0009]). Munger teaches Pt-Co, Fe-Pt-Nb, and other “hard magnetically” Pt alloys at or near the tip of a guide wire or catheter (para. [0024]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify Issacson additional layers of ferromagnetic metal to the shaft (para. [0058]) to be the Pt-Co, Fe-Pt-Nb, and other “hard magnetically” materials of Munger as Munger teaches at the end of para. [0024] that their materials are quite radiopaque, teaches at para. [0025] that the materials would have resisted demagnetization (para. [0018], [0025]-[0026]). Therefore, a skilled artisan at the time of filing would have recognized that the Pt-Co, Fe-Pt-Nb, and other “hard magnetically” Pt alloys would have been an improvement over the ferromagnetic materials of Issacson as they would have provided a more demagnetization-resistance radiopaque magnetized region.
Regarding Claim 2, Issacson as modified teaches 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 (Issacson 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 as modified teaches 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 (Issacson para. [0045] “…a distance d1 and d2 between the magnetic regions 630, 631 and 631…”).
Regarding Claim 6, Issacson as modified teaches 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 (Issacson para. [0045] “…a distance d1 and d2 between the magnetic regions 630, 631 and 631…”).
Regarding Claims 6, 7 and 11, Issacson as modified teaches the medical device according to claim 1 wherein (Claims 6 and 7)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) 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 9, Issacson as modified teaches 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 (Issacson 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 in Issacson).
Regarding Claim 10, Issacson as modified teaches 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 Issacson (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 in Issacson).
Allowable Subject Matter
Claims 22 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
Prosecution Insights