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 .
This Office action is responsive to an amendment filed February 2, 2026. Claims 1-14 are pending. Claims 1 & 6-7 have been amended.
Claim Rejections - 35 USC § 102
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) 1-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishtalas et al. (US 6,248,081) (“Nishtalas” hereinafter).
In regards to claim 1, Nishatalas discloses an endoluminal biopsy tool 13, the tool 13 comprising an outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) and an instrument (15, 55) (e.g., needle 15 is adhesively attached to first tubular member 55 or through a retaining ring or integrally formed therewith) in the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56), wherein the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) and the instrument (15, 55) (e.g., needle 15 is adhesively attached to first tubular member 55 or through a retaining ring or integrally formed therewith) are movable with respect to each other for taking the biopsy, wherein:
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the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) comprises a tongue 25 extending from a distal portion of the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56);
the instrument (15, 55) (e.g., needle 15 is adhesively attached to first tubular member 55 or through a retaining ring or integrally formed therewith) is an inner tube movably fitting inside the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56);
the inner tube comprises a wall comprising a cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) which is closable with the tongue 25 (see at least figs. 2, 4A, 4C & 4E-G; col. 6, lines 26-37); and
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the cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) is shaped as an aperture which around its entire circumference is defined by edges 20 of the wall of the inner tube (e.g., edges 20 of needle 15) (see at least figs. 4A, 4C & 4E-G; col. 6, lines 26-37).
In regards to claim 2, Nishatalas discloses the endoluminal biopsy tool 13 of claim 1, wherein the cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) is closable by a translational advancing movement of the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) with respect to the inner tube (see at least figs. 2, 4A, 4C & 4E-G).
In regards to claim 3, Nishatalas discloses the endoluminal biopsy tool 13 of claim 1, wherein the tongue 25 has a forward cutting edge 28 (see at least figs. 5A-D; col. 6, lines 53-66).
In regards to claim 4, Nishatalas discloses the endoluminal biopsy tool 13 of claim 1, wherein the cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) is closable by a rotational movement of the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) and the inner tube with respect to each other (see at least figs. 2, 3A, 3C & 3E-F; col. 6, lines 18-26).
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In regards to claim 5, Nishatalas discloses the endoluminal biopsy tool 13 of claim 1, wherein the tongue 25 comprises cutting side edges 28 (see fig. 5C).
In regards to claim 6, Nishatalas discloses the endoluminal biopsy tool 13 according to claim 1 wherein:
the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) and the inner tube are translational and/or rotationally movable with respect to each other (see at least figs. 3A, 3C & 3E-F);
the inner tube comprises a bevelled distal portion (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) (see figs. 4E-G); and
the tongue 25 comprises a position wherein the tongue 25 closes off the bevelled distal portion of the inner tube when the inner tube is placed in a partially retracted position with reference to the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) (see at least figs. 3A, 3C & 3E-F).
In regards to claim 7, Nishatalas discloses the endoluminal biopsy tool 13 of claim 6, wherein the tongue 25 has a position in which the tongue 25 protrudes obliquely towards the inner tube when the tongue 25 is unloaded (see at least figs. 3A, 3C & 3E-F).
In regards to claim 8, Nishatalas discloses the endoluminal biopsy tool 13 of claim 1, wherein the tongue 25 is resiliently mounted in an oblique position on the distal portion of the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) (see at least figs. 3A, 3C & 3E-F).
In regards to claim 9, Nishatalas discloses the endoluminal biopsy tool 13 of claim 1, wherein the cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) is closable with the tongue 25 when the inner tube extends beyond the distal portion of the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56), and the tongue 25 is loaded by and engages the inner tube (see at least figs. 2, 3A, 3C & 3E-F).
In regards to claim 10, Nishatalas discloses the endoluminal biopsy tool 13 of claim 9, wherein when the tongue 25 is loaded by the inner tube, the tongue 25 assumes an essentially straight orientation with reference to the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) (see at least figs. 2, 3A, 3C & 3E-F).
In regards to claim 11, Nishatalas discloses the endoluminal biopsy tool 13 of claim 1, wherein the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) comprises a further cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface), the further cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) comprising dimensions that are substantially the same as the dimensions of the cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) in the inner tube (see at least figs. 3C-3F).
In regards to claim 12, Nishatalas discloses the endoluminal biopsy tool 13 of claim 11, wherein the further cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) comprises cutting side edges 20 (see figs. 4A, 4C & 4E-G).
In regards to claim 13, Nishatalas discloses the endoluminal biopsy tool 13 of claim 11, wherein the further cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) extends through and is open at the distal portion of the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) (see figs. 4A, 4C & 4E-G).
In regards to claim 14, Nishatalas discloses the endoluminal biopsy tool 13 of claim 12, wherein the further cut out (19, 20) (e.g., cutting surface 20 of needle 15 is formed to a pointed, angular, cutting surface) extends through and is open at the distal portion of the outer tube (25, 56) (e.g., cutting mechanism 25 is adhesively attached to second tubular member 56) (see figs. 4A, 4C & 4E-G).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5,827,305 to Gordon discloses a tissue sampling device.
US 5,112,339 to Zelman discloses an apparatus for extracting cataractous tissue.
US 4,368,734 to Banko discloses a surgical instrument.
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 RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RENE T TOWA/Primary Examiner, Art Unit 3791
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