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 and Specification
The drawings and substitute specification were received on 8/12/25. These drawings and substitute specification are accepted.
Double Patenting
Claim(s) 2-4, 8-15, 17-18, and 20-23 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-15 of U.S. Patent No. 11937793. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim(s) substantially anticipate(s) the identified claim(s) of this application.
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 2-18, and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter (US 20150057573 A1) in view of Anderson (US 6086543 A) and Mallaby (US 5249583 A).
For claim(s) 2 and 24, Vetter teaches A soft tissue biopsy device [entire disclosure – see at least abstract] (and a method of its use) comprising:
an elongated flexible [¶62] shaft [11] having an internal lumen and a distal end, [Fig. 3]
wherein said elongated flexible shaft is shaped and sized to be introduced via a working channel of an endoscope into a body; [optional length and flexibility of ¶¶62-63 constitute(s), under BRI, a form of a shaft ‘shaped and sized’ for introduction through an endoscope (i.e., Examiner interprets ‘shaped and sized’ to mean capable of such a function — cf. alternate § 103 rejection below)]
a distal hollow sampling portion [11 with cutting beak of 13] coupled to said elongated flexible shaft distal end,
wherein said distal hollow sampling portion comprises an internal sampling lumen and an opening into said internal sampling lumen. [helix 472 and distal portion of lumen of 11 in ¶62 constitute(s), under BRI, a form of an ‘internal lumen’ with a ‘distal cylindrical sampling portion’ and ‘distal opening’ attached to a distal end of 11 (i.e., the portion of 11 proximal to what’s shown in Fig. 2)]
For claim(s) 2, 4, and 24, Vetter fails to teach the device having a stylet.
Anderson a biopsy device [Fig. 7] comprising a sharp stylet [720] shaped and sized to be advanced and retracted within an internal lumen [col. 12 l. 40 – col. 13 l. 20] of a shaft. [704]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the device of Vetter to incorporate the stylet of Anderson (i.e., to place the stylet of Anderson into the lumen of the device of Vetter) in order to further aid in tissue sample acquisition. As motivated by Anderson col. 12 ll. 55-60 and Vetter ¶63.
Vetter in view of Anderson makes obvious most of claim(s) 24 as detailed with claim(s) 2 jointly above.
For claim(s) 2, 5-7 and 24, Vetter in view of Anderson is silent regarding a stylet detector sensor and lock.
Mallaby teaches a biopsy device [abstract] comprising a stylet position sensor [121] that interacts with a stylet lock [55] to sense whether a stylet is in a given extended or retracted position and interacts with the camming stylet lock. [end of col. 6 and throughout cols. 7-8]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the biopsy device of Vetter in view of Anderson to further incorporate the stylet sensor and lock of Mallaby in order to improve stylet and sampling motion accuracy and efficiency. As motivated by Mallaby col. 2 ll. 40-68.
For claim 3, Vetter teaches A biopsy device according to claim 2,
wherein said opening of said hollow sampling portion is a distal front opening. helix 472 and distal portion of lumen of 11 in ¶62 constitute(s), under BRI, a form of an ‘internal lumen’ with a ‘distal cylindrical sampling portion’ and ‘distal opening’ attached to a distal end of 11 (i.e., the portion of 11 proximal to what’s shown in Fig. 2)]
For claim 8, Vetter teaches A biopsy device according to claim 2,
wherein said distal hollow sampling portion is configured to cut through soft body tissue while penetrating into said soft body tissue, and to apply forces on tissue positioned inside said internal lumen of said distal hollow sampling portion that are sufficient to separate tissue inside said internal lumen from the soft body tissue outside said distal hollow sampling portion. , [penetration and cutting of sample tissue at target site is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Vetter – see esp. abstract, ¶¶62-63]
For claim(s) 9-10, Vetter teaches
wherein said distal hollow sampling portion comprises a cutting edge surrounding said distal front opening; wherein said cutting edge is shaped and sized to form a cut in a soft body tissue when penetrating into said soft body tissue; wherein said cutting edge is a circumferential cutting edge surrounding said distal front opening and is shaped and sized to form a round cut in said soft body tissue when penetrating into said soft body tissue. [top and bottom beveled edges of beak 13 constitute(s), under BRI, a form of a ‘circumferential cutting leading edge’ in that the edges of beak 13 are curved and arcuate thus constituting a ‘circumferential’ shape — detailed at length throughout Figs. 4-14]
For claim 11, Vetter teaches A biopsy device according to claim 10,
wherein said circumferential cutting edge is a tapered circumferential cutting edge having an external and/or an internal circumferential tapered region. [sharpened tip ‘scoopula’ and ‘beak’ in ¶¶73-74]
For claim 12, Vetter teaches A biopsy device according to claim 9, comprising:
a driving unit [motor 613/636 and associated gearing of Figs. 23-26] functionally coupled to said elongated flexible shaft configured to rotate said elongated flexible shaft and said distal hollow sampling portion comprising said cutting edge, [rotation and advancement in ¶¶66-67, ¶74 via electrical powering in ¶64, ¶173]
wherein the rotation of the distal hollow sampling portion separates a tissue sample from the soft body tissue. [¶¶61-65]
For claim 13, Vetter teaches A biopsy device according to claim 12,
wherein said driving unit is configured to rotate said elongated flexible shaft and said sampling portion with a speed of at least 100 revolutions-per-minute (RPM) while said sampling portion axially advances into said soft body tissue. [¶77]
For claim 14, Vetter teaches A biopsy device according to claim 12, comprising a gear unit configured to engage said driving unit with said elongated flexible shaft. [gear configurations with DC motor in ¶¶114-131 esp. ¶131 in Fig. 26]
For claim 15, Vetter teaches A biopsy device according to claim 12,
wherein said driving unit is configured to axially advance said distal hollow sampling portion into the tissue in synchronization with said rotation. [¶¶61-65]
For claim(s) 16, Vetter fails to teach two motors. However, such a feature would be an obvious matter of a mere duplication of parts according to one of ordinary skill. See MPEP § 2144.04.
For claim 17, Vetter teaches A biopsy device according to claim 12,
wherein said driving unit comprises a gear motor configured to rotate and axially advance said sampling portion according to a selected ratio between rotation velocity and axial advancement velocity. [rotation and advancement in middle of ¶66 and middle of ¶73 and ¶74 must have at least some form of ratio (i.e., such a value exists regardless of 1:1 rotation to advancement or total advancement before any rotation which would then be a 0:1 ratio — and any and all possible values in between)]
For claim 18, Vetter teaches A biopsy device according to claim 2,
comprising a handle [12] configured to allow manual advancement of said sampling portion. [¶62]
For claim 20, Vetter teaches A biopsy device according to claim 2,
wherein said distal hollow sampling portion is cylindrical and wherein said cutting edge is a circumferential cutting edge surrounding said distal front opening. [sharpened tip ‘scoopula’ and ‘beak’ in ¶¶73-74]
For claim 21, Vetter teaches A biopsy device according to claim 20,
wherein said distal hollow sampling portion is shaped and sized for both coring and tissue separation. [¶¶62-63]
For claim 22, Vetter teaches A biopsy device according to claim 20,
wherein said distal end is flat. [a cross section of distal end of 11 is flat]
For claim 23, Vetter teaches A biopsy device according to claim 2,
wherein an external surface of said distal hollow sampling portion is covered at least partly with a low-friction layer configured to reduce friction with tissue surrounding said sampling portion during movement of said sampling portion. [¶173]
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter in view of Anderson, Mallaby, and Mugan (US 20100121218 A1).
For claim(s) 19, Vetter fails to teach an endoscope lock. However, consider that Vetter does teach in ¶62 that the shaft is generally sufficiently flexible to navigate around sensitive structures and tissues.
Mugan teaches an endoscope lock [100-200] for a biopsy device.
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the device of Vetter to incorporate the endoscope lock of Mugan in order to aid in sampling difficult to reach anatomies. As motivated by Mugan ¶¶3-7, ¶¶14-19 and Vetter ¶62.
Response to Arguments
Applicant's 8/12/25 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 9 that Vetter and Anderson do not address the position detector. Examiner respectfully submits that such a feature in claim(s) 2 and 5 is jointly addressed by Mallaby — all limitations of claim(s) 2 and 5 were addressed in the previous office action and are done so again herein. All prior art rejections are re-stated verbatim from the past office action herein (in view of the non-amended claim(s) ).
Applicant argues in remarks p. 9-10 that the combination of Vetter and Anderson would modify Vetter away from its original purpose (i.e., destructive inoperability). Examiner respectfully disagrees. Anderson details throughout col. 12 l. 40 – col. 13 l. 40 that stylet 720 may be retracted during operation to ensure tissue collection. Nothing in the operation of the stylet as detailed in Anderson nor any other structure in Vetter would mean Vetter would be unable to collected and proximally transport multiple samples (e.g., through subsequent further retractions of the stylet). To wit, the use of a stylet does not necessitate that only a single sample be acquired via a single insertion. Accordingly, Examiner respectfully submits that Applicant’s does not properly characterize the teachings of the references.
“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791