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 .
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 may be 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) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teague (US 20090131826 A1) in view of Lonky (US 20130267870 A1).
For claim(s) 1, Teague teaches A biopsy device for sampling cells or tissue in a subject, the biopsy device comprising:
a tubular member [114] defining a lumen;
and an elongated member [101] movably arranged within the lumen of the tubular member,
wherein a distal portion [104] of the elongated member comprises a tissue capture arrangement including a plurality of rigid protrusions [108] protruding in a radial direction from the elongated member [Fig(s). 3A-B]
wherein a ratio between the radial height of the protrusions and the diameter of the elongated member is between 1:3 and 1:20 [22 or 25 gauge diameter for member 101 in ¶65 for then barbs of 0.25-5 mm barbs in ¶45]
Teauge fails to teach the device arranged for insertion into the vasculature of the subject.
Lonky teaches a sampling device and method [abstract] including a configuration for insertion into a blood or lymphatic vessel site. [¶68 ¶75]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the device of Teague to incorporate the blood / lymphatic vessel sampling functionality of Lonky in order to aid in diagnosis via biomarkers which may be present in the blood / lymphatic vessels (e.g., lesions or materials on the vessel’s surface). As motivated by Lonky ¶3, ¶110.
For claim(s) 2, Teague teaches The biopsy device according to claim 1,
wherein a height of the protrusions in a radial direction is substantially smaller than a diameter of the elongated member. [Fig(s). 3]
For claim(s) 4, Teague teaches The biopsy device according to claim 1,
wherein the radial height of the protrusions is in the range 3-100 μm. [barb 108 is at a max height of 0.25 mm from outer surface of member 101 in ¶45 and tapers backward to the surface of 101 as in Fig(s). 3A so that there is at least some portion of barb 108 which is 3-100 μm from the surface of 101 (e.g., a form of ‘radial height’ under BRI)]
For claim(s) 5, Teague teaches The biopsy device according to claim 1,
wherein the plurality of protrusions comprises a structure of pillars regularly distributed around the circumference of the elongated member and/or along the length of the distal portion. [Fig(s). 3 and ¶46]
For claim(s) 6, Teague teaches The biopsy device according to claim 5,
wherein the plurality of protrusions is arranged in a substantially uniform grid pattern or an offset pattern. [Fig(s). 3]
For claim(s) 7, Teague teaches The biopsy device according to claim 1,
wherein a ratio between a distance between adjacent protrusions and a radial height of the protrusions is in the range 1:2 to 5:1. [¶¶45-47]
For claim(s) 8, Teague teaches The biopsy device according to claim 1,
wherein a ratio between a width and a radial height of the protrusions is in the range 1:2 to 2:1. [¶¶45-47]
For claim(s) 9, Teague teaches The biopsy device according to claim 1,
wherein the protrusions are formed on one or more tubular sheaths [110] arranged on the distal portion of the elongated member.
For claim(s) 10, Teague teaches The biopsy device according to claim 1,
wherein each protrusion comprises a sharp edge for penetrating and/or cutting tissue oriented in a tangential direction and/or longitudinal direction of the elongated member. [Fig(s). 3]
For claim(s) 11, Teague teaches The biopsy device according to claim 10,
wherein the sharp edge forms an overhang defining a collecting cavity adjacent each protrusion. [space under barbs 108 is a form of an overhang defining a collecting cavity — see esp. Fig(s). 2D]
For claim(s) 12, Teague teaches The biopsy device according to claim 1,
wherein at least the distal portion of the elongated member is made of a superelastic material. [¶10]
For claim(s) 13, Teague teaches The biopsy device according to claim 1,
wherein the protrusions are formed in a single monolithic structure. [¶67]
For claim(s) 14, Teague teaches The biopsy device according to claim 1,
wherein the protrusions are formed by additive manufacturing. [this is a product-by-process claim — see MPEP § 2113 where since Teague teaches the barbs, then the claimed structure is taught]
For claim(s) 15, Teague teaches The biopsy device according to claim 1,
wherein the protrusions are made of a polymer selected from polyether, polyamide, polyimide or polytetrafluoroethylene (PTFE) or made of a metal. [¶10]
For claim(s) 16, Teague teaches The biopsy device according to claim 1,
wherein a distal tip of the tubular member and/or elongated member is sharp for penetrating and/or cutting tissue. [distalmost of 108 constitute(s), under BRI, a form of a sharp distal tip]
For claim(s) 17, Teague teaches A m0ethod for sampling cells or tissue in a subject, the method comprising:
providing a tubular member, [114] and an elongated member [101] movably arranged within a lumen of the tubular member,
wherein a distal portion [104] of the elongated member comprises a tissue capture arrangement including a plurality of rigid protrusions [108] protruding in a radial direction from the elongated member, [Fig(s). 3A-B]
wherein a ratio between the radial height of the protrusions and the diameter of the elongated member is between 1:3 and 1:20 [22 or 25 gauge diameter for member 101 in ¶65 for then barbs of 0.25-5 mm barbs in ¶45]
introducing the tubular member into a target anatomy the of the subject to reach a sampling site; [Fig(s). 2D]
advancing the elongated member such that the distal portion of the elongated member exits the tubular member; [Fig(s). 2A]
moving the elongated member such that the protrusions scrape the inner wall of the sample site [Fig(s). 2D];
retracting the elongated member into the lumen of the tubular member; [Fig(s). 2B]
and retracting the tubular member from the sample site. [¶12]
For claim(s) 18, Teague teaches The method according to claim 17,
wherein the step of advancing comprises advancing the elongated member until the distal portion of the elongated member becomes wedged inside the sample site and the step of moving comprises rotating the elongated member. [Fig(s). 2D in ¶¶37-38]
For claim(s) 17 and 18, Teague fails to teach the method having a target anatomy and sample site being a blood or lymphatic vessel. Consider, however, that Teague does teach in ¶8 a general use of the device for sampling in body lumens including endoscopically.
Lonky teaches a sampling device and method [abstract] comprising a step of sampling at a blood or lymphatic vessel site. [¶68 ¶75]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the method of Teague to incorporate the blood / lymphatic vessel sampling of Lonky in order to aid in diagnosis via biomarkers which may be present in the blood / lymphatic vessels (e.g., lesions or materials on the vessel’s surface). As motivated by Lonky ¶3, ¶110.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teague in view of Lonky and Goh (US 20230363745 A1).
Teague fails to teach the width of the protrusions being 3-100µm.
Goh teaches a sampling device [abstract] where a width of protrusions is 100µm. [¶93]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the protrusions of Teague to incorporate the dimensions of the protrusions of Goh in order to ensure proper sample retention. As motivated by Goh ¶¶4-10.
Response to Arguments
Applicant's 7/16/26 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 7 that Teague fails to teach rigid protrusions under BRI. Examiner respectfully disagrees. The barbs 108 of Teague have at least some form of rigidity under BRI where the barbs 108 do not fold backwards when encountering tissue nor deform against tissue surfaces when pushed forward — but instead are expressly for severing tissue. As such, the barbs 108 of Teague constitute(s), under BRI, a form of ‘rigid protrusions’.
Applicant argues in remarks p. 7 that Teague fails to teach the ratio of the protrusion height to the member diameter is not 1:30 to 1:20. Examiner respectfully disagrees. The barbs form a tapering slope down onto the outer surface of the elongate member in Teague Fig(s). 3 such that there is at least some heigh measured from the outer surface to some point in the slope of the barb that is less than a maximum of 0.25mm such that the ratio of the barb height to the 22 gauge needle would be in the range of 1:3 to 1:20. Examiner suggests amending the claims(s) to further limit the specific features by which the height of the protrusions are defined so as to readily distinguish from the teachings of Teague.
Applicant argues in remarks p. 8-9 that Lonky fails to teach the claimed height to diameter ratio. Examiner respectfully submits that the Lonky reference is not relied upon to teach such a feature in the § 103 rejections.
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
