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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Examiner notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 10-11 and 15-16 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The term “sharp” in claim(s) 10-11 and 16 is a relative term which renders the claim indefinite. The term “sharp” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
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) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teague (US 20090131826 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]
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) 3, Teague teaches The biopsy device according to claim 2,
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]
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 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 such as polyether, polyamide, polyimide or polytetrafluoroethylene (PTFE) or 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. [distalmost of 108 constitute(s), under BRI, a form of a sharp distal tip]
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) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teague in view of Lonky (US 20130267870 A1).
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]
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.
Pertinent Prior Art
Prior art made of record and not relied upon which is considered pertinent to applicant's disclosure is provided in the Notice of References Cited (form PTO-892) herewith.
Conclusion
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
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