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 .
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.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orts et al. (WO 2018/098239 A1, hereinafter Orts).
For claim 1, Orts discloses a biopsy apparatus (10) (Figs 1-7) ([0029-0077]), comprising inter alia:
a biopsy probe assembly (14) having a cutter cannula (50), a vacuum cannula (44), and a stylet cannula (46) coaxially arranged along a longitudinal axis (Fig 4) ([0043]), the vacuum cannula being positioned inside the stylet cannula to define a first intermediate lumen therebetween (Fig 4-6H) ([0043]), the stylet cannula being positioned within the cutter cannula to define a second intermediate lumen therebetween (Fig 4-6H) ([0043]), and the vacuum cannula having a vacuum lumen (lumen of 44) (Fig 4-6H) ([0043]), wherein:
the stylet cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position (Fig 4-6H) ([0008, 0043-0077]); and
the stylet cannula has a plurality of vent openings (80), the plurality of vent openings including at least one longitudinal vent slot (80) (Fig 4) ([0077]); and
a seal (72, 74) (Fig 5A) ([0075-0077]) having a proximal seal portion (74) and a distal seal portion (72), the distal seal portion having a distal seal lip (72) that is positioned for radial engagement with an outside diameter of the cutter cannula (Fig 5A) ([0075-0077]), and the proximal seal portion having a proximal seal lip (74) that is positioned for radial engagement with an outside diameter of the stylet cannula (Fig 5A) ([0075-0077]), wherein:
when the stylet cannula is moved from the first extended position toward the first retracted position, the at least one longitudinal vent slot is longitudinally positioned under the proximal seal lip of the proximal seal portion of the seal (Figs 4-7) ([0042-0077]) so as to open a seal bypass path across a longitudinal extent of the proximal seal lip of the proximal seal portion of the seal (Figs 4-7) ([0042-0077]) so as to establish both a first air path at the first intermediate lumen between an outside diameter of the vacuum cannula and an inside diameter of the stylet cannula (Figs 4-7) ([0042-0077]) and a second air path at the second intermediate lumen between an inside diameter of the cutter cannula and the outside diameter of the stylet cannula (Figs 4-7) ([0042-0077]), the first air path and the second air path being in fluid communication with a region proximal to the seal (Figs 4-7) ([0042-0077]).
For claim 2, Orts discloses the biopsy apparatus of claim 1, further comprising a driver assembly (12) having an electromechanical power source (20) and a vacuum source (22), wherein the biopsy probe assembly is releasably attached to the driver assembly (Fig 2) ([0029]).
For claim 3, Orts discloses the biopsy apparatus of claim 1, further comprising a driver assembly (12) having an electromechanical power source (20) and a vacuum source (22), wherein the vacuum lumen of the vacuum cannula is coupled in fluid communication with the vacuum source (Fig 3) ([0030]).
For claim 4, Orts discloses the biopsy apparatus of claim 1, further comprising a driver assembly (12) having an electromechanical power source (20) and a vacuum source (22), wherein the stylet cannula is coupled in driving communication with the electromechanical power source (Fig 3).
For claim 5, Orts discloses the biopsy apparatus of claim 1, further comprising a driver assembly (12) having an electromechanical power source (20) and a vacuum source (22), wherein the cutter cannula is coupled in driving communication with the electromechanical power source (Fig 3).
For claim 6, Orts discloses the biopsy apparatus of claim 1, wherein the cutter cannula is movable relative to the stylet cannula between a second extended position to cover a sample notch (60) ([0046-0048]) of the stylet cannula and a second retracted position to expose the sample notch when the stylet cannula is in the first extended position (Figs 4-7) ([0042-0077]).
For claim 7, Orts discloses the biopsy apparatus of claim 1, wherein the stylet cannula has a proximal portion (proximal portion of 46) (Figs 4-7) ([0042-0077]) and a distal portion (distal portion of 46) (Figs 4-7) ([0042-0077]), the distal portion defining a sample notch (60) (Figs 4-7) ([0042-0077]).
For claim 8, Orts discloses the biopsy apparatus of claim 7, wherein the plurality of vent openings are arranged at a location proximal to the sample notch (Fig 4).
For claim 9, Orts discloses the biopsy apparatus of claim 7, wherein the first air path and the second air path converge at the sample notch (Figs 4-7) ([0042-0077]).
For claim 10, Orts discloses the biopsy apparatus of claim 1, wherein the plurality of vent openings includes at least two longitudinal vent slots (80) (Fig 4) ([0071-0077]).
For claim 11, Orts discloses the biopsy apparatus of claim 10, wherein a first longitudinal vent slot (one of 80) and a second longitudinal vent slot (another of 80) are diametrically opposed (Fig 4) ([0071-0077]).
For claim 12, Orts discloses the biopsy apparatus of claim 1, wherein the plurality of vent openings includes at least one circular vent hole (80) (Fig 4) ([0071-0077]).
For claim 13, Orts discloses the biopsy apparatus of claim 12, wherein a proximal end of the at least one longitudinal vent slot is aligned with the at least one circular vent hole (Fig 4) ([0071-0077]).
For claim 14, Orts discloses a method (Figs 1-7, especially 6A-6H) ([0029-0077, especially 0043-0077]), comprising inter alia:
applying vacuum (Figs 4A-6H) ([0043-0077]) via a vacuum cannula (44) of a biopsy apparatus (10) to a lumen (lumen of 46) of a stylet cannula (46) of the biopsy apparatus at a sample notch (60) of the stylet cannula, wherein:
a cutter cannula (50) of the biopsy apparatus, the vacuum cannula, and the stylet cannula, are coaxially arranged along a longitudinal axis (Fig 4) ([0043]), the vacuum cannula being positioned inside the stylet cannula to define a first intermediate lumen therebetween (Fig 4-6H) ([0043]), the stylet cannula being positioned within the cutter cannula to define a second intermediate lumen therebetween (Fig 4-6H) ([0043]), and the vacuum cannula having a vacuum lumen (lumen of 44) (Fig 4-6H) ([0043]);
the stylet cannula is movable relative to the vacuum cannula and the cutter cannula between a first extended position and a first retracted position (Fig 4-6H) ([0008, 0043-0077]);
the stylet cannula has a plurality of vent openings (80) (Fig 4) ([0077]), the plurality of vent openings including at least one longitudinal vent slot (80) (Fig 4) ([0077]); and
the biopsy apparatus comprises a seal (72, 74) (Fig 5A) ([0075-0077]) having a proximal seal portion (74) (Fig 5A) ([0075-0077]) and a distal seal portion (72) (Fig 5A) ([0075-0077]), the distal seal portion having a distal seal lip (72) (Fig 5A) ([0075-0077]) that is positioned for radial engagement with an outside diameter of the cutter cannula (Fig 5A) ([0075-0077]), and the proximal seal portion having a proximal seal lip (74) (Fig 5A) ([0075-0077]) that is positioned for radial engagement with an outside diameter of the stylet cannula (Fig 5A) ([0075-0077]); and
moving the stylet cannula toward the first retracted position to move a severed tissue sample into the vacuum cannula (Figs 4A-6H) ([0043-0077]), wherein:
when the stylet cannula is moved toward the first retracted position, the at least one longitudinal vent slot is longitudinally positioned under the proximal seal lip of the proximal seal portion of the seal (Figs 4A-6H) ([0043-0077]) so as to open a seal bypass path across a longitudinal extent of the proximal seal lip of the proximal seal portion of the seal (Figs 4A-6H) ([0043-0077]) so as to establish both a first air path at the first intermediate lumen between an outside diameter of the vacuum cannula and an inside diameter of the stylet cannula (Figs 4A-6H) ([0043-0077]) and a second air path at the second intermediate lumen between an inside diameter of the cutter cannula and the outside diameter of the stylet cannula (Figs 4A-6H) ([0043-0077]), the first air path and the second air path being in fluid communication with a region proximal to the seal (Figs 4A-6H) ([0043-0077]).
For claim 15, Orts discloses the method of claim 14, wherein the cutter cannula is movable relative to the stylet cannula between a second extended position to cover the sample notch and a second retracted position to expose the sample notch when the stylet cannula is in the first extended position (Figs 4A-6H) ([0043-0077]).
For claim 16, Orts discloses the method of claim 15, further comprising: moving the stylet cannula toward the first extended position to pierce a tissue with the stylet cannula (Figs 4A-6H) ([0043-0077]); and moving the cutter cannula toward the second retracted position to expose the sample notch of the stylet cannula (Figs 4A-6H) ([0043-0077]), wherein: applying vacuum via the vacuum cannula draws the tissue into the lumen of the stylet cannula through the sample notch (Figs 4A-6H) ([0043-0077]).
For claim 17, Orts discloses the method of claim 16, further comprising: moving the cutter cannula to the second extended position to sever the severed tissue sample from the tissue (Figs 4A-6H) ([0043-0077]).
For claim 18, Orts discloses the method of claim 14, wherein the first air path and the second air path converge at the sample notch (Figs 4A-6H) ([0043-0077]).
For claim 19, Orts discloses the method of claim 14, further comprising applying vacuum via the vacuum cannula while moving the stylet cannula toward the first retracted position to move the severed tissue sample into the vacuum cannula (Figs 4A-6H) ([0043-0077]).
For claim 20, Orts discloses the method of claim 14, wherein the plurality of vent openings includes at least two longitudinal vent slots (80) (Fig 4) ([0071-0077]), wherein a first longitudinal vent slot and a second longitudinal vent slot are diametrically opposed (Fig 4) ([0071-0077]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring biopsy specimen retrieval with varying suction configurations.
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
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