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 .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 03/25/2026 is acknowledged.
Claims 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/25/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 333 as disclosed in [0018] and 433 as disclosed in [0018]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the two or more magnets of claim 22 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 7 is 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.
Claim 7 recites the limitation “cup-shaped end of the shaft”. It is unclear what does and does not constitute cup-shaped. In other words, it is unclear what shape of a cup the limitation intends (e.g. round, cylindrical, recessed, etc.). For examination purposes, it has been interpreted that any round or recessed shape is considered cup-shaped, however, clarification is required.
Claim Rejections - 35 USC § 102
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 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 1-3 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foreign Wang et al. (EP3037044 A1), hereinafter Wang. Examiner notes that citations to Wang are with respect to the copy provided by applicant.
Regarding claim 1,
Wang discloses a device (at least fig. 1 (18) and corresponding disclosure in at least [0053]) for retrieving a magnetic marker (at least fig. 1 (12) and corresponding disclosure in at least [0055]. See also [0097] which discloses magnetic attractive forces of magnetic tip of the manipulator 16 and the magnetically acting portion 62 of the muco-adhesive element 12 and [0070] which discloses magnetically acting portion 52 has at least one magnet fixed to the polymer body 20. 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 comprising:
An introducer (at least fig. 6 (14/70) and corresponding disclosure in at least [0079]) having a tip (see at least figs. 6-7); and
An obturator (at least fig. 6 (16/82) and corresponding disclosure in at least [0079]) disposed within the introducer, the obturator having a magnetic end (at least fig. 6 (86) and corresponding disclosure in at least [0082]), wherein the obturator is operable such that the magnetic end (86) is enclosed within the introducer in a first position of the obturator (see at least fig. 7) and the magnetic end (86) extends at least partially beyond the tip of the introducer in a second position of the obturator (See at least fig. 8 and [0087] which discloses the non-magnetic stop 76 extends beyond the distal end of the outer tube 70 and the magnetic tip 86 abutts against the non-magnetic stop 76. Examiner notes that in such an arrangement with the non-magnetic stop 76 extending beyond the distal end of the outer tube 70 and corresponding abutting of the magnetic tip that the magnetic tip extends at least partially beyond the tip of the introducer in the second position of the obturator 16/84)
Regarding claim 2,
Wang further discloses wherein the obturator (16) comprises a shaft (82) and a permanent magnet ([0082] which discloses the magnetic tip 86 can be configured as a tubular magnet meaning) affixed to the shaft (84) at the magnetic end of the obturator (See at least figs. 6 and 7).
Regarding claim 3,
Wang further discloses wherein the permanent magnet (86) is adhered at an end of the shaft (82) (Examiner notes that a person having ordinary skill in the art would have recognized that the probe 82 having the magnetic tip (including a tubular magnet) would require adherence of the magnet (i.e. tubular magnet) to the distal end of the shaft 82).
Regarding claim 16,
Wang further discloses further comprising an ejector (at least fig. 6A (160/164) and corresponding disclosure in at least [0084]) arranged through the obturator (82/16) ([0084] which discloses In the deflated state, the additional component 160 can be introduced through the trough hole 90 of the tube 82 until the inflatable member 164 protrudes from the distal end of the magnetic tip 86) and operable to extend beyond the magnetic end of the obturator ([0084] which discloses until the inflatable member 164 protrudes form the distal end of the magnetic tip 86).
Regarding claim 17,
Wang further discloses wherein the ejector is coaxial with the obturator (See at least figs. 6-7 and [0084] which discloses the component 160/inflatable member 164 introduced through hole 90, thus coaxial with the obturator 16).
Claims 1(alternatively), 2 (alternatively), and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whalen et al. (US 65514304 B1), hereinafter Whalen.
Regarding claim 1 (alternatively),
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).
Regarding 2, alternatively,
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 discloses 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 discloses 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 discloses 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).
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Coleman et al. (US 5945901 A), hereinafter Coleman.
Regarding claim 7,
Wang teaches the elements of claim 1 as previously stated. Wang further teaches wherein a portion of the permanent magnet is shaped to correspond with an end of the shaft (see at least fig. 6).
Examiner notes that the end of the shaft is round, thus may be considered cup-shaped, however, for an interpretation of cup-shaped meaning recessed, is not explicitly clear if the end of the shaft is considered cup shaped.
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 cup-shaped 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 Wang to include that the permanent magnet is shaped to correspond with a cup-shaped 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 cup-shaped holder as taught by Coleman at the distal end of the shaft of Wang 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 Wang in view of Jones et al. (US 20190307434 A1), hereinafter Jones.
Regarding claim 8,
Wang teaches the elements of claim 1 as previously stated. Wang further teaches wherein the shaft is hollow, however, wang fails to explicitly teach wherein 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 a permanent magnet 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 Wang 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 Wang 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,
Wang teaches the elements of claim 2 as previously stated. Wang fails to explicitly teach wherien the permanent magnet is mechanically affixed at an end of the shaft using screw threads, a dovetail fitting, or an interference fit.
Jones, 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 Wang 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 Wang 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 10-12 (alternatively) are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Whalen.
Regarding claim 10,
Wang teaches the elements of claim 1 as previously stated. Wang fails to explicitly teach wherein the permanent magnet comprises Neodymium.
Whalen, in a similar field of endeavor involving magnetic device retrieval, teaches wherein a 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 Neodymium 27).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the permanent magnet of Wang to include Neodymium in order to provide a magnetic coupling between the device to be retrieved and the permanent magnet accordingly. Such a modification amounts to merely a simple substitution of one known magnetic coupling material for another yielding predictable results with respect to magnetic device retrieval thereby rendering the claim obvious (MPEP 2143).
Regarding claim 11,
Wang teaches the elements of claim 1 as previously stated. Wang fails to explicitly teach wherein the permanent magnet comprises a bio-compatible material.
Whalen, in a similar field of endeavor involving magnetic device retrieval, 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).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Wang to include a biocompatible material as taught by Whalen in order to protect the magnet from bodily fluids and enhance the safety of the procedure by providing materials that are compatible to the body over the magnet such that the body is protected from any direct contact with the magnet.
Regarding claim 12,
Whalen, as applied to claim 11 above, 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)
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Whalen in view of Bornzin et al. (US 20170064269 A1), hereinafter Bornzin or in the alternative Wang and Whalen as applied to claim 11 above and further in view of Bornzin.
Regarding claim 13,
Whalen, or in the alternative Wang and 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 or Wang and Whalen 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 Wang in view of Bonner et al. (US 20050209564 A1), hereinafter Bonner.
Regarding claim 18,
Wang teaches the elements of claim 16 as previously stated. While Wang teaches the medical instrument kit is suitable for use in minimally invasive or minimal access surgery, Wang fails to explicitly teach the ejector comprises a bio-compatible material.
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 Wang 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 Wang.
Regarding claim 19,
Wang, 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,
Wang teaches the elements of claim 2 as previously stated. While Wang teaches the medical instrument kit is suitable for use in minimally invasive or minimal access surgery, Wang fails to explicitly teach wherein the shaft comprises a bio-compatible material.
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 Wang 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 Wang.
Regarding claim 21,
Wang, 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 in view of Anderson (US 6105474 A1), hereinafter Anderson.
Regarding claim 22,
Wang teaches the elements of claim 2 as previously stated. Wang 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 Wang 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. Palese et al. (US 20120130164 A1) teach an obturator having a magnetic end (fig. 2 (170), fig. 14 (250), fig. 26 (650)) and in a first position the magnetic end is enclosed into an introducer and in a second position the magnetic end extends at least partially beyond the tip of the introducer (see at least figs. 1-2, 13-14, and 25-26)
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.
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, Anne Kozak can be reached at 5712700552. 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.
/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
Prosecution Insights