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 .
Response to Arguments
Regarding drawings
Examiner notes that the drawings objections are withdrawn in view of the replacement drawings.
Furthermore, Applicant’s arguments, see REMARKS, filed 07/23/2026, with respect to the drawings objections of claim 2, have been fully considered and are persuasive. The drawings objections of claim 2 has been withdrawn.
Regarding 35 U.S.C. 112(b)
Examiner notes that the 112(b) rejection is withdrawn in view of the amendments to the claims.
Regarding prior art
Applicant’s arguments with respect to claim 1 have been considered but are moot in view of the new grounds of rejection necessitated by amendment. Specifically new teachings are relied upon to teach the ejector.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 2, 10-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Whalen et al. (US 65514304 B1), hereinafter Whalen in view of Opolski .
Regarding claim 1,
Whalen discloses a device (at least fig. 5-5B) and corresponding disclosure in at least Col. 6) for retrieving a magnetic marker (at least fig. 5 (22) and corresponding disclosure in at least Col. 2 lines 17-27. Examiner further notes that the limitation is directed towards intended use and limitations directed towards intended use must result in a structural difference between the claimed invention and the prior art and that the prior art must merely be capable of being used for retrieving a magnetic marker implanted in an individual) implanted in an individual (Col. 1 lines 10-14 which disclose retrieving a device which is positioned within a remote location. This location is preferably located within the human body) comprising:
An introducer (at least fig. 5 (346) and corresponding disclosure in at least Col. 6); and
An obturator (at least fig. 5 (344 and 334) and corresponding disclosure in at least Col. 6) and corresponding disclosure in at least [0079]) disposed within the introducer (see at least figs. 5 and 5A), the obturator having a magnetic end (at least fig. 5 (334) and corresponding disclosure in at least Col. 6), wherein the obturator is operable such that the magnetic end (334) is enclosed within the introducer in a first position of the obturator (see at least fig. 5A) and the magnetic end (334) extends at least partially beyond the tip of the introducer in a second position of the obturator (see at least fig. 5).
Whalen fails to explicitly teach an ejector disposed within the obturator, wherein an end of the ejector is contained within the obturator in a first position of the ejector and the end fo the ejector extends through the obturator beyond the magnetic end of the obturator in a second position of the ejector, wherein the ejector is configured to push the magnetic marker off of the magnetic end of the obturator by moving the ejector from the first position of the ejector to the second position of the ejector.
Opolski, in a similar field of endeavor involving magnetic instruments for implantable devices, teaches a device for retrieving a magnetic marker comprising:
an instrument (at least fig. 5A (460) and corresponding disclosure in at least [0054]) having a magnetic end (at least fig. 5A-5B (415) and corresponding disclosure in at least [0053]) configured to attach to a magnetic marker (at least frig. 5A-5B (255) and corresponding disclosure in at least [0043]), and
An ejector (at least fig. 5A and 5B (500) and corresponding disclosure in at least [0056]) disposed within the obturator (see at least fig. 5A and 5B), wherein an end of the ejector is contained within the obturator in a first position of the ejector (see at least fig. 5A) and the end of the ejector extends through the obturator beyond the magnetic end of the obturator in a second position of the ejector (see at least fig. 5B), wherein the ejector is configured to push the magnetic marker off of the magnetic end of the obturator by moving the ejector from the first position of the ejector to the second position of the ejector (see figs. 5A-5B and [0057] which discloses the releasing element 500 exerts a force sufficient to counter the magnetic attraction between the attachment device 460 and the implant 250, causing their separation (FIG. 5B)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whalen to include an ejector as taught by Opolski and a passage way through the obturator and magnet in order to allow for releasing the implant from the obturator. Such a modification would allow for releasing an implant for relocation (Opolski [0016]) or delivery to a desired location (Opolski [0015]). Furthermore, such a modification would allow for sanitary release of an implant outside of the body upon retrieving a medical device thereby avoiding a user having to physically separate the implant from the obturator by hand.
Regarding 2,
Whalen further discloses wherein the obturator comprises a shaft (344) and a permanent magnet (Col. 2 lines 54-57 which discloses the preferred magnetic material for magnetic coupling 34 (thus 334 in the fourth embodiment) is Neodynium 27. Where 334 as a magnetic coupling having neodymium as the material is considered a permanent magnet) affixed to the shaft (344) (see at least fig. 5 and Col. 6 which discloses first elongate member 344 is secured near the distal extremity 350 to distal inner hub 370 and near the proximal extremity to magnetic coupling 334) at the magnetic end of the obturator (see at least figs. 5 and 5A)
Regarding claim 10,
Whalen further teaches wherein the permanent magnet comprises neodymium (Col. 2 lines 54-57 which discloses the preferred magnetic material for magnetic coupling 34 (thus 334 in the fourth embodiment) is Neodynium 27).
Regarding claim 11,
Whalen further teaches wherein the permanent magnet comprises a bio-compatible material (Col. 2 lines 40-57 which disclose all the magnetic materials are preferably coated with a suitable coating for biocompatible inertness such as class VI epoxy or vapor deposited paraxylene).
Regarding claim 12,
Whalen further teaches wherein the permanent magnet comprises an enclosure comprising the bio-compatible material (Col. 2 lines 40-57 which disclose all the magnetic materials are preferably coated with a suitable coating for biocompatible inertness such as class VI epoxy or vapor deposited paraxylene. Such a coating is considered an enclosure in its broadest reasonable interpretation).
Regarding claim 17,
Whalen, as modified, teaches the elements of claim 1 above. Whalen, as modified, further teaches wherein the ejector is coaxial with the obturator (see at least figs. 5A-5B of Opolski, where it is noted that the ejector is coaxial with the instrument (i.e. obturator of Whalen))
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Whalen and Opolski, as applied to claim 2 above, and further in view of Hall et al. (US 20020029056 A1), hereinafter Hall .
Regarding claim 3,
Whalen, as modified, teaches the elements of claim 2 as previously stated. Whalen appears to teach that the permanent magnet is adhered at an end of the shaft, however, the nature of affixing between the permanent magnet and the shaft is not explicitly disclosed by Whalen.
Nonetheless, Hall, in a similar field of endeavor involving magnetic retrieval devices, teaches a permanent magnet adhered at an end of a shaft ([0026]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whalen, as currently modified, to include adhering the permanent magnet at the end of the shaft as taught by Hall in order to secure the magnet to the shaft accordingly. Furthermore, such a modification amounts to a simple substitution of one known affixing means for another yielding predictable results with respect to affixing of elements to a shaft, thereby rendering the claim obvious (MPEP 2143).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Whalen and Opolski, as applied to claim 2 above, and further in view of Coleman et al. (US 5945901 A), hereinafter Coleman.
Regarding claim 7,
Whalen teaches the elements of claim 1 as previously stated. Whalen further teaches wherein a portion of the permanent magnet is shaped to correspond with an end of the shaft (see at least fig. 5)
Whalen fails to explicitly teach wherein a portion of the permanent magnet is shaped to correspond with a recessed end of the shaft
Nonetheless, Coleman in a similar field of endeavor involving magnetic retrieval instruments, teaches a permanent magnet (at least fig. 2 (12) and corresponding disclosure in at least (See at least fig. 12 (26) and corresponding disclosure in at least Col. 3 lines 63-col. 4 line 4) shaped to correspond with a recessed end (See at least fig. 12 (26) and corresponding disclosure in at least Col. 3 lines 63-col. 4 line 4) of a shaft.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whalen, as currently modified, to include that the permanent magnet is shaped to correspond with a recessed end of the shaft as taught by Coleman in order to provide for a distal end which holds the magnet in place. A person having ordinary skill in the art would have recognized the benefit of securing the magnet in a recessed holder as taught by Coleman at the distal end of the shaft of Whalen to ensure that the magnet stays with the shaft accordingly. Furthermore, such a modification amounts to merely a simple substitution of one known distal end shape of a shaft for another yielding predictable results with respect to securing of magnets to a shaft thereby rendering the claim obvious (MPEP 2143).
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Whalen and Opolski, as applied to claims 1 and 2 above, in view of Jones et al. (US 20190307434 A1), hereinafter Jones.
Regarding claim 8,
Whalen teaches the elements of claim 1 as previously stated. Whalen fails to explicitly teach wherein the shaft is hollow and the permanent magnet is at least partially disposed within an end of the hollow shaft.
Nonetheless, Jones, in a similar field of endeavor involving magnetic retrieval, teaches an obturator comprising a shaft (at least fig. 2 (112’) and corresponding disclosure in at least [0072]), wherein the shaft at least fig. 2 (112’) and corresponding disclosure in at least [0072] ) is hollow (see at least fig. 2) and a permanent magnet (124) is at least partially disposed within an end of a hollow shaft (at least fig. 2 (112’) and corresponding disclosure in at least [0072] and [0083] which discloses recovery magnet 124 may be disposed within a channel 124c and in place using a friction fit at the distal end of the extension shaft 112’).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whalen, as currently modified, to include at least partially disposing the permanent magnet within an end of a hollow shaft as taught by Jones in order to secure the magnet to the distal end of the shaft accordingly. A person having ordinary skill would have recognized the benefit of modifying the shaft of Whalen such that the permanent magnet is disposed at least partially therein in order to provide a friction fit at the distal end to thereby ensure no movement of the permanent magnet relative to the shaft accordingly.
Regarding claim 15,
Whalen teaches the elements of claim 2 as previously stated. Whalen fails to explicitly teach wherein the permanent magnet is mechanically affixed at an end of the shaft using screw threads, a dovetail fitting, or an interference fit.
Whalen, in a similar field of endeavor involving magnetic retrieval, teaches a permanent magnet is mechanically affixed at an end of a shaft using an interference fit (at least fig. 2 (112’) and corresponding disclosure in at least [0072] and [0083] which discloses recovery magnet 124 may be disposed within a channel 124c and in place using a friction fit (i.e. interference fit) at the distal end of the extension shaft 112’).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whalen, as currently modified, to include mechanically affixing the permanent magnet at an end of the shaft as taught by Jones in order to secure the magnet to the distal end of the shaft accordingly. A person having ordinary skill would have recognized the benefit of modifying the shaft of Whalen such that the permanent magnet is disposed at least partially therein in order to provide a friction fit at the distal end to thereby ensure no movement of the permanent magnet relative to the shaft accordingly.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Whalen and Opolski, as applied to claim 2 above, in view of Bornzin et al. (US 20170064269 A1), hereinafter Bornzin.
Regarding claim 13,
Whalen teaches the elements of claim 11 as previously stated. Whalen fails to explicitly teach wherein the bio-compatible material is surgical stainless steel, titanium, nitinol, polycarbonate, an acetyl, copolymer, PEEK, or combinations thereof.
Nonetheless, Bornzin, in a similar field of endeavor involving medical devices, teaches a permanent magnet ([0021] which discloses marker 112 encloses the permanent magnet in a BCM housing) comprises a biocompatible material that is stainless steel or titanium ([0020] which discloses a BCM such as titanium or stainless steel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whalen, as modified, to include a bio-compatible material such as surgical stainless steel or titanium in order to protect the magnet from body fluids accordingly. Such a modification further amounts to merely a simple substitution of one known bio-compatible material for another yielding predictable results with respect to magnet protection thereby rendering the claim obvious (MPEP 2143).
Claims 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Whalen and Opolski, as applied to claims 1 and 2 above, and further in view of Anderson in view of Bonner et al. (US 20050209564 A1), hereinafter Bonner.
Regarding claim 18,
Whalen, as modified, teaches the elements of claim 16 as previously stated. While Opolski teaches that the ejector is made of a metal or plastic ([0056]) and is understood to be extendable past the instrument (or obturator of Whalen) while inside of the body thus appearing to be biocompatible, there is no explicit disclosure in Opolski of the metal or plastic being “biocompatible”.
Bonner, in a similar field of endeavor involving medical instruments, teaches that tissue and/or bodily fluid contacting components of a tool comprise a bio-compatible material ([0257]).
It would have been obvious to a person having ordinary skill in the art before the effective date to have modified the ejector of Whalen, as modified, to comprise a bio-compatible material as taught by Bonner in order to provide ensure that undesirable reactions in the body, have the physical properties required to function for it intended purpose, may be purified, fabricated and sterilized easily, and will substantially maintain its physical properties and function during the time that it remains in contact with tissues or fluids of the body (Bonner [0257]), thereby enhancing the safety and effectiveness of the ejector of Whalen, as modified.
Regarding claim 19,
Whalen, as modified, teaches the elements of claim 18 as previously stated. Bonner, as applied to claim 18 above further teaches wherein the biocompatible material is surgical stainless steel, titanium, polycarbonate, or combinations thereof ([0258]).
Regarding claim 20,
Whalen, as modified, teaches the elements of claim 2 as previously stated. While Whalen teaches that the device is used for retrieving an indwelling device which is retrievable from a urinary tract environment (Col. 2) and the shaft extends past the tip of the introducer during retrieval and thus would appear to be biocompatible, there is no such disclosure that the shaft comprises a bio-compatible material in Whalen.
Bonner, in a similar field of endeavor involving medical instruments, teaches that tissue and/or bodily fluid contacting components of a tool comprise a bio-compatible material ([0257]).
It would have been obvious to a person having ordinary skill in the art before the effective date to have modified the shaft of Whalen, as modified, to comprise a bio-compatible material as taught by Bonner in order to provide ensure that undesirable reactions in the body, have the physical properties required to function for it intended purpose, may be purified, fabricated and sterilized easily, and will substantially maintain its physical properties and function during the time that it remains in contact with tissues or fluids of the body (Bonner [0257]), thereby enhancing the safety and effectiveness of the shaft of Whalen.
Regarding claim 21,
Whalen, as modified, teaches the elements of claim 20 as previously stated. Bonner, as applied to claim 18 above further teaches wherein the biocompatible material is surgical stainless steel, titanium, polycarbonate, or combinations thereof ([0258]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Whalen and Opolski, as applied to claim 2 above, and further in view of Anderson (US 6105474 A1), hereinafter Anderson.
Regarding claim 22,
Whalen, as modified, teaches the elements of claim 2 as previously stated. Whalen fails to explicitly teach wherein the permanent magnet comprises two or more magnets.
Anderson, in a similar field of endeavor involving magnetic tools teaches a permanent magnet comprises two or more magnets (Col. 6 lines 62-67 which discloses (9) In FIGS. 9 and 10, two disks or pill magnets 24, 24a of the type shown in FIGS. 2 and 3 are used to double the strength of the magnetic field, the two magnets being positioned on diametrically opposite sides of the channel 14 to ensure that the fields produced by each of the magnets similarly couples to the driver bit).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whalen, as modified, to include two or more magnets as taught by Anderson in order to increase the strength of the magnetic field (Anderson col. 6). Examiner notes that a person having ordinary skill in the art would have recognized the benefit of providing two or more magnets as the permanent magnet in order to increase the magnetic field strength thereby ensuring that retrieval of the magnetic device is successful.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Trieu et al. (US 20070174857 A1) teaches an ejector (at least figs. 7-8 (770) and disclosure in at least [0043]) disposed within an obturator (see at least figs. 7-8), wherein an end of the ejector is contained within the obturator in a first position of the ejector (see at least fig. 7) and the end of the ejector extends through the obturator beyond the magnetic end of the obturator in a second position of the ejector (see at least fig. 8),wherein the ejector (770) is configured to push a marker (100 and [0041] which discloses Note that the tool embodiments of FIGS. 6-8 assume that intervertebral device 100 is at least partially formed of a metallic material susceptible to a magnetic attractive force generated (or existing) within engagement mechanism 620) off of the magnetic end (720 and [0042]) of the obturator by moving the ejector from the first position of the ejector to the second position of the ejector (see at least fig. 8 and [0043] which discloses In the extended position, the intervertebral device is magnetically coupled to engagement mechanism 720 of surgical inserter tool 700, while in the retracted position, the pusher element at the end of pusher shaft 770 physically separates the intervertebral device from the surgical inserter tool, interrupting the magnetic coupling therebetween).
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 BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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