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 .
Drawings
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, a plurality of slits disposed along a spine of a notch of a stylet 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 § 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.
Claim(s) 1-6, 9-17, 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan (US 2011/0288437) in view of Wegener (US 2011/0190661).
Regarding claim 1, Ryan discloses a biopsy tool (abstract) comprising:
a flexible cannula (element 102; paragraph [0019]) having a cutting surface on a distal end portion of the flexible cannula (element 118); and
a flexible stylet (element 104; paragraph [0020]) disposed at least partially within and extending from the distal end portion of the flexible cannula (figure 1), the flexible stylet having an “atraumatic” tip disposed on a distal end portion of the flexible stylet (element 110).
The Examiner notes that “atraumatic” in the context of the disclosure of the instant invention still includes causing “trauma” or otherwise cutting and puncturing tissue, where the only other aspect causing the “atraumatic” tip to be “atraumatic” is its shielding of the cutting surface of the cannula – see paragraphs [0037], [0040] of the disclosure as filed.
Ryan does not disclose how the “atraumatic” tip and cutting surface interact when the flexible cannula and the flexible stylet are in a closed configuration.
Wegener teaches a biopsy tool comprising:
a cannula (element 120) having a cutting surface on a distal end portion of the cannula (element 122); and
a stylet disposed at least partially within and extending from the distal end portion of the cannula (element 110), the stylet having an “atraumatic” tip disposed on a distal end portion of the flexible stylet (element 111),
wherein the “atraumatic” tip is configured to at least partially shield the cutting surface of the flexible cannula when the flexible cannula and the flexible stylet are in a closed configuration (at element 114 – see figure 1 in the bottom illustration).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the tool of Ryan with the “atraumatic” tip configured to at least partially shield the cutting surface of the cannula when closed, as taught by Wegener, in order to provide a surface against which the cutting surface can cut to provide a clean severing of tissue.
Regarding claim 2, Ryan further discloses that the “atraumatic” tip is configured to puncture tissue of a patient (claim 7).
Regarding claim 3, Ryan further discloses that a shape of a proximal end portion of the “atraumatic” tip is configured to complement a shape of at least a portion of the cutting surface when the flexible cannula and the flexible stylet are in the closed configuration (figure 2).
Regarding claim 4, Wegener further teaches that the proximal end portion of the “atraumatic” tip includes a first surface and a second surface, each oriented at least partially toward a proximal end of the biopsy tool (see annotated figure, 1 showing two surfaces at least partially facing the proximal end of the tool).
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Regarding claim 5, Ryan further discloses that the flexible stylet includes a notch (element 114) configured to be exposed to an exterior environment when the flexible cannula and flexible stylet are in an open configuration (figure 1) and disposed within the flexible cannula when the flexible cannula and flexible stylet are in the closed configuration (figure 2).
Regarding claim 6, Ryan further discloses that a distal portion of the notch is angled to prevent the cutting surface from catching the distal portion of the notch as the flexible cannula and the flexible stylet move from the open configuration to the closed configuration (see figures 1 and 2, the angle of the distal portion of the notch prevents the cutting surface from catching it).
Regarding claim 9, Wegener further teaches that a distal end portion of the “atraumatic” tip is chamfered (figure 1, surfaces at a plurality of relative angles in the tip section). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Ryan and Wegener, as modified above, where a distal end portion of the “atraumatic” tip is chamfered, as further taught by Wegener, in order to avoid abrupt transitions between the surfaces of the tip.
Regarding claim 10, Ryan further discloses that the biopsy tool is configured to apply suction to tissue proximate to the flexible stylet when the flexible cannula and the flexible stylet are in an open configuration (paragraph [0033]).
Regarding claim 11, Ryan further discloses that the flexible cannula includes a plurality of slits (figure 11).
Regarding claims 12 and 13, any amount of the flexible cannula’s distal end can be considered part of “the cutting surface” such that the “proximal end” of this surface can be anywhere along the “distal” end of the cannula such that these slits could be considered to be near or not near this “proximal end” – see figure 11).
Regarding claim 14, Ryan further discloses that the flexible cannula and the flexible stylet are biased to the closed configuration (paragraph [0025]).
Regarding claim 15, Ryan further discloses that the flexible cannula and the flexible stylet are biased to the closed configuration by a spring loaded actuator (paragraph [0025]).
Regarding claim 16, Ryan further discloses that an outer maximum transverse dimension of the atraumatic tip disposed on the distal end portion of the flexible stylet is between approximately 1 mm and 2 mm (paragraph [0020]).
Regarding claim 17, Ryan further discloses that the biopsy tool does not include a sheath (Ryan does not disclose a sheath or outer covering for the device).
Regarding claim 46, Ryan further discloses that the flexible stylet includes a solid portion extending between the notch and the atraumatic tip, the solid portion configured to be at least partially received within the distal end portion of the flexible cannula (see figure 2).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan as modified by Wegener as applied above, and further in view of McGhie (US 2013/0102925).
Regarding claim 7, Ryan does not further disclose that the flexible stylet includes a plurality of slits disposed along a spine of the notch. Valencia teaches a biopsy tool comprising a flexible cannula (element 102) and a flexible stylet disposed at least partially within and extending from a distal end portion of the flexible cannula (element 104), where the flexible stylet includes a plurality of slits disposed along a spine of a notch (figure 5, see the slits forming “ridges” 504a). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Ryan, as modified, with a plurality of splits disposed along a spine of the notch, as taught by McGhie, in order to help the notch retain tissue during use.
Claim(s) s 44 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan as modified by Wegener as applied above, and further in view of Long (US 2020/0187919).
Ryan, as modified above, does not disclose that the flexible stylet further includes a stop surface proximal of the notch, the stop surface configured to restrict distal motion of the flexible cannula relative to the flexible stylet and a protruding surface proximal of the cutting surface, wherein the protruding surface is configured to abut the stop surface to restrict distal motion of the flexible cannula relative to the flexible stylet. Long teaches a biopsy tool comprising a flexible cannula (element 102) having a cutting surface on a distal end portion (element 114) and a flexible stylet disposed within the cannula (element 104), the stylet comprising a notch configured to be exposed to an exterior environment when the cannula and stylet are in an open configuration (element 122), a stop surface proximal of the notch, the stop surface configured to restrict distal motion of the flexible cannula relative to the flexible stylet (paragraphs [0118], [0119]), and a protruding surface proximal of the cutting surface, wherein the protruding surface is configured to abut the stop surface to restrict distal motion of the flexible cannula relative to the flexible stylet (paragraphs [0118], [0119]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the biopsy tool of Ryan, as modified, with a stop surface and a protruding surface configured to control distal motion of the cannula relative to the stylet, as taught by Long, in order to ensure the cannula operates as intended.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Ort (US 2016/0317133).
Regarding claim 8, Ryan discloses a biopsy tool (abstract) comprising:
a flexible cannula (element 102; paragraph [0019]) having a cutting surface on a distal end portion of the flexible cannula (element 118); and
a flexible stylet (element 104; paragraph [0020]) disposed at least partially within and extending from the distal end portion of the flexible cannula (figure 1), the flexible stylet having an “atraumatic” tip disposed on a distal end portion of the flexible stylet (element 110).
The Examiner notes that “atraumatic” in the context of the disclosure of the instant invention still includes causing “trauma” or otherwise cutting and puncturing tissue, where the only other aspect causing the “atraumatic” tip to be “atraumatic” is its shielding of the cutting surface of the cannula – see paragraphs [0037], [0040] of the disclosure as filed.
Ryan does not disclose how the “atraumatic” tip and cutting surface interact when the flexible cannula and the flexible stylet are in a closed configuration or relative dimensions of the atraumatic tip and cutting surface of the cannula, particularly an outer maximum transverse dimension of the atraumatic tip being larger than an outer maximum transverse dimension of the flexible cannula at least at a leading distal end of the cutting surface.
Orts teaches a biopsy tool comprising:
a cannula (element 1’) having a cutting surface on a distal end portion of the cannula (paragraph [0036]); and
a stylet disposed at least partially within and extending from the distal end portion of the cannula (element 3), the stylet having an “atraumatic” tip disposed on a distal end portion of the flexible stylet (element 4’),
wherein the “atraumatic” tip is configured to at least partially shield the cutting surface of the flexible cannula when the flexible cannula and the flexible stylet are in a closed configuration (figure 9) with an outer maximum transverse dimension of the atraumatic tip being larger than an outer maximum transverse dimension of the flexible cannula at least at a leading distal end of the cutting surface (see figure 9, at the intersection 26 between tip and cutting surface the tip is larger than the cutting surface).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the tool of Ryan with the “atraumatic” tip configured to at least partially shield the cutting surface of the cannula when closed and to be maximally transversely larger than the distal end of the cutting surface, as taught by Ort, in order to form “a cutting bord to ensure that connective tissue is cut properly during severing.” (Ort, paragraph [0036])
Response to Arguments
Applicant's arguments filed 12 June 2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Wegener’s surface 114 could not serve as a surface against which a cutting surface cuts because Wegener discusses the surface 114 being shaped “to avoid formation of a transition between the sheath and the needle portion that would allow tissue to be cut by the sharpened end portion as the device is advanced to the target tissue” (emphasis added). It should be noted that this is describing a different activity than the act of biopsying where the stylet tip and cannula are separated to allow tissue to make contact with the cutting surface and then be severed using the cutting surface as the cutting surface moves back into contact with the tip’s proximal non-cutting surface (that is, Wegener’s 114). Ensuring a flush surface between sheath and needle portion during advancement of the device to the target does not in any way teach against or suggest that, once the target has been reached and the two components are actively separated and used to perform a biopsy, Wegener’s intent is to somehow prevent tissue located between the cutting surface and surface 114 from being biopsied during a biopsy procedure using that cutting surface to cut the tissue. The fact that the inventor has recognized another advantage, also preventing cutting during advancement, which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant next argues that Ryan’s cutting mechanism does not require or benefit from a surface against which the cutting surface can be cut; the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. See MPEP 2144. Established scientific principles would show one of ordinary skill in the art that cutting a soft tissue sample against a hard surface would increase the ease and accuracy of cutting, thereby providing a more efficient cutting procedure benefitting Ryan’s cutting mechanism. That Ryan’s cutting mechanism does not require such a surface to operate does not negate the potential benefit of adding such a surface as disclosed by Wegener. The need for potential improvement does not need to be shown in Ryan as incorrectly asserted by Applicant, nor does the improvement need to be recognized by Wegener so long as the advantage provided by the improvement is present.
Regarding claims 44 and 45, Applicant asserts that the motivation to further modify Ryan and Wegener with Long is “conclusory” but does not present any argument or evidence as to why this motivation is inaccurate beyond a general assertion of further modification not being necessary; this general allegation is entirely unpersuasive.
Applicant’s arguments with respect to claim(s) 8 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. Applicant’s remarks address only Wegener, no longer applied against the claim as amended.
Regarding the objection to the drawings, Applicant asserts that a description of “similarity” to illustrated slits in a different component with no indication of what aspect is similar or what degree of resemblance is considered “similar”, and a description of the function of the slits without any showing or description of any features which provide this functionality beyond the general use of “transverse” and “angled” with no frame of reference, would render an illustration of the only limitation which further defines claim 7 from claim 1 unnecessary; this is entirely unpersuasive. The objection stands.
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.
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/KAREN E TOTH/ Examiner, Art Unit 3791
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