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 .
Notice of Amendment
This communication is responsive to the amendment(s) and argument(s) filed 11/17/25. The previous ground(s) of rejection is/are withdrawn and the following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 6-7, 10-11, 18 and 22-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Igal (WO 2013168166 A1).
For claim 1, Igal discloses a biopsy assembly (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25), comprising inter alia:
a biopsy tube (200) defining a lumen (hollow interior of 200) (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25);
a tissue penetrator (100) having a distal tip (distal tip 135 of 100) shaped to penetrate through tissue (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25), wherein said tissue penetrator is positioned within said lumen (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25) and comprising inter alia:
an elongated flexible body (100) shaped and sized to move within said biopsy tube lumen (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25); and
a collapsible distal cutting portion (120) coupled to said body and extending out from said lumen in an expanded state in front of said biopsy tube (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25) (Fig 10C clearly shows advancement of the distal cutting portion in front of an exterior opening of the biopsy tube), and configured to collapse to a width smaller than an inner width of said lumen in a collapsed state (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25),
wherein said collapsible distal cutting portion comprises a distal sharp cutting edge (edge of 120) (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25), configured to perform a thin cut-through said tissue (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25),
wherein in an expanded state a maximal width of said collapsible distal cutting portion is larger than an inner width or an inner diameter of said biopsy tube lumen (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25), and
wherein said collapsible distal cutting portion is coupled to a distal end of said elongated flexible body (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25); and
wherein said distal tip is an integral part of said collapsible distal cutting portion (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25).
For claim 2, Igal discloses the biopsy assembly according to claim 1, wherein said collapsible distal cutting portion is in a form of a thin and flexible layer (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25).
For claim 6, Igal discloses the biopsy assembly according to claim 1, wherein a thickness of said distally facing sharp cutting edge is smaller than 0.1 mm (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25).
For claim 7, Igal discloses the biopsy assembly according to claim 1, wherein a surface of said distally facing sharp cutting edge facing tissue is at least partly angled or at least partly curved (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25).
For claim 10, Igal discloses the biopsy assembly according to claim 1, wherein a cross-section of a circumference of said collapsible distal cutting portion facing tissue, in an expanded state, is a continuous arc (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25).
For claim 11, Igal discloses the biopsy assembly according to claim 10, wherein said arc subtends an angle of at least 30 degrees (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25).
For claim 18, Igal discloses the biopsy assembly according to claim 2, wherein said thin and flexible layer is configured to furl at least partly around said elongated flexible body (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25), to a width smaller than an inner width of said lumen (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25).
For claim 22, Igal discloses the biopsy assembly according to claim 1, wherein a minimal thickness of a wall of said biopsy tube surrounding said lumen is at least 10% of the inner diameter of the biopsy tube (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25).
For claim 23, Igal discloses the biopsy assembly according to claim 1, wherein a minimal thickness of a wall of said biopsy tube is 0.05 mm (Figs 1, 6, 9E-9I) (Pgs 10-15, 19-25).
Response to Arguments
Applicant's arguments filed 11/17/25 have been fully considered but they are not persuasive. Applicant argues the following:
Claim 1 has been amended to recite exactly what is claimed in the granted European sister patent EP4175559.
Igal is the same cited reference (D4) brought by the European examiner in the, now granted, European sister patent EP4175559.
Respectfully, the applicant requests for claim 1 to be found novel and inventive over Igal, because Igal apparently does not teach all the features of currently amended claim 1.
The applicant would like to mention that the European also evaluated the claims in view of D1-US20180140289A1, D2-US10441254, D3-US20150272556A1 and D5-W02016010735A1, and found the claims novel and inventive.
The Examiner respectfully notes in response the following:
Prosecution of and/or patent granting of related subject matter in a sister application in front of another patent office has no bearing on the patentability of the instant US Application, particularly given distinction(s) in patent laws and rules therebetween.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
THIS ACTION IS MADE FINAL. 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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791