DETAILED ACTION
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) 12,13 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austen (2018/0193054) in view of Andelin et al. (6,110,128) and further in view of Householder et al. (2015/0313579). Austen discloses a method of manufacturing a biopsy needle (120) including a tubular elongated body ([0033], lines 2-6 and [0056], lines 2-6) with an inner lumen and an outer wall surface (Figs. 1A,7) comprising crimping by inward deformation of the outer wall surface of the tubular needle body ([0056], lines 11-13) at a plurality of locations to form a plurality of crimps (130,710; [0035], lines 11-12 and [0056], line 3) that are straight edged or curved ([0035], lines 5-8) or angled ([0056], lines 4-5). The crimps (710) are equidistantly spaced longitudinally wherein Fig. 7 illustrates that the crimps (710) are spaced a distance from a distal end (110) of the tubular needle (12), are discrete (angled barbs) and are spaced from each other equally where crimp (710; left side Fig. 7) is between crimps (710; right side Fig. 7). Each crimping location (130,710) forms a retaining member ([0036], lines 5-8 and [0056], lines 8-10) that extends within the tubular body lumen and each retaining member (130,710) does not extend around a circumference of the lumen.
Austen does not explicitly state that the plurality of crimping locations extend at least 10 cm form the distal end (110; Fig. 7) of the tubular needle body and are spaced approximately 1 to 2 cm apart. Andelin teaches a plurality of retaining members (20) comprising barbs (20a; col. 5, lines 38-40) or ribs (20b,20c) that extend from about one inch to an entire length (col. 5, lines 21-26) in an internal lumen (18) of a biopsy needle (12). Andelin teaches that the retaining members (20) are spaced about 1-2 mm apart (col. 5, lines 42-43) and suggests other spacing between the retaining members wherein graduations (28) are manufactured on the needle cannula (14; col. 5, lines 7- 10) in cm or mm. It would have been obvious to the skilled artisan to extend the retaining members of Austen at least 10 cm from a distal needle end and to space the retaining members by a mm or cm graduation as taught by Andelin so as to retain the tissue sample along the lumen according to a depth of penetration of the needle to a graduated distance that is verifiable by the physician.
Austen in view of Andelin does not disclose that an introducer needle is used with the biopsy needle. Householder teaches an introducer needle (100) which is a coaxial cannula structure (102) that is connected with a coupling (180) to a handle (20) of a biopsy device (10), the introducer needle supporting a biopsy needle (50) having a tissue sampling cutting portion (70) at a distal end of the biopsy needle. It would have been obvious to the skilled artisan prior to the effective filing date of the present invention to attach an introducer needle to the handle of the biopsy tool of Austen in view of Andelin as taught by Householder so as to introduce the biopsy needle anatomically to a position for the biopsy needle to take the tissue sample.
Regarding claim 13, Austen discloses that the crimping locations comprise a retaining member (710) that is at an angle of between 45-90 degrees (Fig. 7) with the longitudinal axis of the needle (120).
Regarding claim 15, each retaining member (710) extends "generally" a same distance toward a center of the lumen (Fig. 7) wherein Austen illustrates that they extend a same distance.
Regarding claim 16, Austen discloses that the crimps (130) extend between 10-50% into the lumen ([0036], lines 1-5).
Regarding claim 17, Austen discloses a generally D-shaped retaining member (Fig. 1C) in a curved (130) structure.
Regarding claim 18, Austen discloses that the distal end of the needle (110) is non-circular (tapered, [0039], lines 1-4) to push aside tissue as the needle penetrates wherein a retaining member (710) is positioned at the tapered end of the needle and extends inwardly ([0056], lines 4-8).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austen (2018/0193054) in view of Andelin et al. (6,110,128) and Householder et al. (2015/0313579) and further in view of Everett (2,728,343). Austen discloses that at least two retaining members (710; Fig. 7) are longitudinally aligned but does not disclose that all of the retaining members are longitudinally aligned. Everett teaches a tubular elongated needle body (1) including an outer surface (Fig. 1) in which a plurality of crimps (5,6,7,8,9; col. 1, lines 51-55) are formed at a plurality of spaced locations that extend into a lumen (2) of the elongated needle body (Fig. 2). The plurality of crimps (5,6,7,8,9) form a plurality of retaining members (col. 2, lines 4-9) that do not extend around a circumference of the lumen (2), wherein the crimps (5,6,7,8,9) are formed as distinct indentations in an upper surface (col. 2, lines 8-9) of the elongated needle body and are longitudinally aligned along the outer surface of the elongated needle body. It would have been obvious to the skilled artisan prior to the effective filing date of the present invention to longitudinally align all of the crimps of Austen as taught by Everett to accomplish one sided retention within the lumen of the needle.
Response to Arguments
Applicant's arguments filed 12-22-2025 have been fully considered. The reference to Householder is used to respond to Applicants amendment to an introducer needle. An introducer needle is a widely used coaxial cannula operable to introduce a target biopsy needle into an anatomical region and Andelin teaches that a coaxial coupling (24) comprising connection portion (50; Fig. 11) is used to handle the biopsy needle (col. 5, lines 66-67 and col. 6, lines 3-4) wherein projections (20a,20b,20c) extend a graduation distance (28) in centimeters along the biopsy needle and the projections extend about one inch or about 2/3 a length of the cannula (14; col. 5, lines 21-25) from a distal end (30) of the cannula but do not extend to the coaxial coupling (24; Fig. 8). Householder (Fig. 1B) shows the tissue sampling cutter (70) exposed beyond the end of the introducer needle so that the cutter is positioned for taking a sample. It is an obvious modification to include an introducer needle in the biopsy device of Austen in view of Andelin as taught by Householder to protect and guide the biopsy needle.
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 EDWARD THOMAS TOLAN whose telephone number is (571)272-4525. The examiner can normally be reached M-F 7:30-5.
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/EDWARD T TOLAN/Primary Examiner, Art Unit 3725