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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a tissue characterizing biopsy apparatus, in the reply filed on 11/4/25 is acknowledged.
Claims 27-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/4/25.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a tissue sensing unit” in claim 1;
“a connector element” in claim 1;
“a coupling matrix” in claim 9;
“a receiving matrix” in claim 10;
“an alignment mechanism” in claim 11; and
“a control unit” in claim 21.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 1 is objected to because of the following informalities: the positive recitation of “and” in line 7 should apparently be at the end of line 14 instead. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: the positive recitation of “a sensor” should apparently read “one of said one or more sensors”, or the like, as it relates to antecedent clarity. Similar antecedent issues could be clarified in claim 5 regarding the recitation of “said at least one tissue characterization sensor” and claim 10 regarding the recitation of “said one or more sensors”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the positive recitation of “a connection board” should apparently read “the connection board” given the antecedent from claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 7 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "said flat transmission strip" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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) 1-18, 21-26, and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chuong et al. (US 10,905,404 B2, hereinafter Chuong).
For claim 1, Chuong discloses a biopsy system (Figs 2, 11-18) (Cols 13-18), comprising inter alia:
(a) a removable biopsy device (2100) comprising:
- an inner needle (hollow tubular cutter) (Col 13) (Figs 2, 11-18) (Cols 13-18) comprising a tip (hollow tubular cutter tip) (Figs 2, 11-18) (Cols 13-18) configured to pierce tissue and a tissue sensing unit (2103) (Figs 2, 11-18) (Cols 13-18) for characterizing tissue properties, at least part of said tissue sensing unit being positioned on said inner needle (around 2305, Fig 11 and 13) (Figs 2, 11-18) (Cols 13-18);
- a recess (longitudinally extending lumen/recess of hollow tubular cutter) (Col 13) (Figs 2, 11-18) (Cols 13-18) formed longitudinally in said inner needle proximal to said tip and configured for receiving a tissue portion from a region of interest (Figs 2, 11-18) (Cols 13-18);
- an outer sheath (2113) configured to change position relative to said inner needle between a forward position of said sheath in which said sheath covers the recess and a backward position of the sheath in which said recess and said at least part of said tissue sensing unit are uncovered (Figs 2, 11-18) (Cols 13-18) (see also Chuong’s referenced 2014/0039343 disclosing independently rotatable and translatable inner and outer needles/cannulas), said outer sheath comprising a cutting edge (2112) at its distal end configured to cut and enclose said tissue portion into said recess when moving relatively to the needle from the backward position to the forward position (Figs 2, 11-18) (Cols 13-18); and
- a connector element (electrical connectivity for analyzing bioimpedance) (Figs 2, 11-18) (Cols 13-18) configured for receiving sensing signals from said tissue sensing unit (Figs 2, 11-18) (Cols 13-18); and
(b) a handle (2300) for receiving said removable biopsy device (Figs 2, 11-18) (Cols 13-18); said handle comprising a registration assembly (2300) (Figs 2, 11-18) (Cols 13-18) including:
- a socket (2302) tiltable between a rest position and a tilted position (Figs 2, 11-18) (Cols 13-18), and having a sliding channel for receiving said connector element (Figs 2, 11-18) (Cols 13-18); and
- a connection board (electrical continuity of Cols 13-18, esp Col 16) for electrically coupling said connector element when the connector element is received in the sliding channel and the socket is in the rest position (Figs 2, 11-18) (Cols 13-18).
For claim 2, Chuong discloses the biopsy system of claim 1, wherein said tissue sensing unit includes: one or more sensors (2309) positioned at a distal portion of said inner needle and a transmission strip (Figs 2, 11-18) (Cols 13-18) connected to said one or more sensors and to said connector element (Figs 2, 11-18) (Cols 13-18).
For claim 3, Chuong discloses the biopsy system of claim 2, wherein at least one of said one or more sensors is an impedance controlled tissue characterization sensor (2309) (Figs 2, 11-18) (Cols 13-18).
For claim 4, Chuong discloses the biopsy system of claim 2, wherein a sensor (2309) is positioned at said tip of said inner needle (Figs 2, 11-18) (Cols 13-18).
For claim 5, Chuong discloses the biopsy system of claim 4, wherein said inner needle comprises a groove (2307) at said tip configured to accommodate therein at least said at least one tissue characterization sensor (Figs 2, 11-18) (Cols 13-18), such that an upper surface of the sensor does not protrude above outer surface of said tip (Figs 2, 11-18) (Cols 13-18).
For claim 6, Chuong discloses the biopsy system of claim 2, wherein an array of space-apart sensors (multiple 2309) is positioned in said recess (Figs 2, 11-18) (Cols 13-18).
For claim 7, Chuong discloses the biopsy system of claim 2, wherein at least part of said transmission strip is fixedly attached to a surface of said inner needle (Figs 2, 11-18) (Cols 13-18).
For claim 8, Chuong discloses the biopsy system of claim 1, wherein said biopsy device is disposable (Figs 2, 11-18) (Cols 13-18).
For claim 9, Chuong discloses the biopsy system of claim 1, wherein said connector element includes a coupling matrix of spaced apart sensor couplers (Col 16).
For claim 10, Chuong discloses the biopsy system of claim 9, wherein said registration assembly comprises the connection board which includes a receiving matrix configured to be attached to said coupling matrix to receive and transmit said signals from and to said one or more sensors (Col 16).
For claim 11, Chuong discloses the biopsy system of claim 10, wherein said registration assembly comprises an alignment mechanism (2309, 2338) configured to spatially align between said receiving matrix and said coupling matrix (Figs 2, 11-18) (Cols 13-18).
For claim 12, Chuong discloses the biopsy system of claim 11, wherein said alignment mechanism is configured to slide said connector element and position said receiving matrix with said coupling matrix to enable impedance controlled attachment between them (Figs 2, 11-18) (Cols 13-18).
For claim 13, Chuong discloses the biopsy system of claim 11, wherein said alignment mechanism is configured to align between said coupling matrix and said receiving matrix by pressing one against another (Figs 2, 11-18) (Cols 13-18).
For claim 14, Chuong discloses the biopsy system of claim 10, wherein said connection board is fixed to a housing element of said handle (Figs 2, 11-18) (Cols 13-18, esp Col 16).
For claim 15, Chuong discloses the biopsy system of claim 10, wherein said connector element comprises a plurality of fixation pins or holes associated structurally to said coupling matrix, and said connection board includes matching holes or pins associated structurally to said receiving matrix to thereby enable the transmission of signal from and to the sensors (Col 16).
For claim 16, Chuong discloses the biopsy system of claim 10, wherein said connector element has at least one conical pin configured to enter at least one respective conical hollow receiver at the connection board thereby facilitating three-dimensional alignment of the connector element with the connection board (Col 16).
For claim 17, Chuong discloses the biopsy system of claim 1, wherein said handle is configured as a two-part housing comprising a first part (2310) comprising a movement mechanism configured for enabling relative movement between the inner needle and the outer sheath and an installation mechanism (2330) configured for installing a proximal portion of the biopsy device in the handle (Figs 2, 11-18) (Cols 13-18), and a second part comprising said registration assembly (Figs 2, 11-18) (Cols 13-18).
For claim 18, Chuong discloses the biopsy system of claim 1, wherein said tiltable socket is associated to a housing element of the handle by a pivot allowing tilting of said tiltable socket (Figs 2, 11-18) (Cols 13-18).
For claim 21, Chuong discloses the biopsy system of claim 1, configured to communicate with a control unit (control module, Col 16) to transmit to the control unit input data indicative of signals from said tissue sensing unit (Figs 2, 11-18) (Cols 13-18), thereby causing the control unit to analyze said signals (Figs 2, 11-18) (Cols 13-18), and generate output data to inform a user about a tissue portion condition and enable acquisition of a tissue sample (Figs 2, 11-18) (Cols 13-18).
For claim 22, Chuong discloses the biopsy system of claim 1 wherein the biopsy system includes a sensor (2309) sensing a location of at least one sensor of said tissue sensing unit (Figs 2, 11-18) (Cols 13-18).
For claim 23, Chuong discloses the biopsy system of claim 1 wherein the biopsy system includes a sensor (2309) sensing orientation and/or moving status of said biopsy device (Figs 2, 11-18) (Cols 13-18).
For claim 24, Chuong discloses the biopsy system of claim 1, wherein the tissue sensing unit includes one or more sensors (2309) positioned at a distal tip of said inner needle and said distal tip is protruding from said sheath in said forward position (Figs 2, 11-18) (Cols 13-18).
For claim 25, Chuong discloses the biopsy system of claim 1, wherein a distal end of said tip is aligned axially with the sheath edge in said forward position (Figs 2, 11-18) (Cols 13-18).
For claim 26, Chuong discloses the biopsy system of claim 1, wherein said sheath is free of impedance sensors (Figs 2, 11-18) (Cols 13-18).
For claim 38, Chuong discloses a biopsy system (Figs 2, 11-18) (Cols 13-18), comprising inter alia:
(a) a handle (2300) for receiving a removable biopsy device (2100) (Figs 2, 11-18) (Cols 13-18);
(b) said removable biopsy device comprising:
- an inner needle (hollow tubular cutter) (Col 13) (Figs 2, 11-18) (Cols 13-18) comprising a tip (tip of hollow tubular cutter) (Col 13) (Figs 2, 11-18) (Cols 13-18) configured to pierce tissue and a tissue sensing unit (2103) (Figs 2, 11-18) (Cols 13-18) for characterizing tissue properties (Figs 2, 11-18) (Cols 13-18), at least part of said tissue sensing unit being positioned on the inner needle (around 2305, Fig 11 and 13) (Figs 2, 11-18) (Cols 13-18);
- a recess (longitudinally extending lumen/recess of hollow tubular cutter) (Figs 2, 11-18) (Cols 13-18) formed longitudinally in said inner needle proximal to the tip and configured for receiving a tissue portion from a region of interest (Figs 2, 11-18) (Cols 13-18);
- an outer sheath (2113) (Figs 2, 11-18) (Cols 13-18) configured to change position relative to the inner needle between a forward position of the sheath in which the sheath totally covers the recess and a backward position of the sheath in which the recess and the at least part of the tissue sensing unit are uncovered (Figs 2, 11-18) (Cols 13-18) see also Chuong’s referenced 2014/0039343 disclosing independently rotatable and translatable inner and outer needles/cannulas), the outer sheath comprising a cutting edge (Figs 2, 11-18) (Cols 13-18) at its distal end configured to cut and enclose the tissue portion into the recess when moving relatively to the needle from the backward position to the forward position (Figs 2, 11-18) (Cols 13-18); and
- a connector element (Col 16) configured for receiving sensing signals from said tissue sensing unit and delivering the signals to a control unit using the mating structure of claim 32.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chuong.
For claims 19 and 20, Chuong discloses the claimed invention including the handle is shaped elongated and has a transverse rectangular cross-section along a portion of its length (Figs 2, 11-18) (Cols 13-18). Chuong does not explicitly disclose the handle cross-section having a perimeter of 14-25 cm or a total weight of said handle and said biopsy device is less than 400 gr. Chuong is expressly concerned with configuring multi-piece impedance tissue characterization biopsy retrieval device for tissue sampling but appears silent regarding the handle dimensions and weight. However, at the time of filing, one of ordinary skill in the art would have found the handle dimension and weight obvious because it would have been obvious to try configuring a handheld instrument with appropriate dimensions and heft. One of ordinary skill would have had a finite number of handheld dimensions and weights to consider with a reasonable expectation of success, to achieve the predictable solution of a configuring a biopsy device to be handheld to tissue acquisition.
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 biopsy device 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791