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
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 21st, 2026.
Applicant’s election without traverse of Group I (Claims 1-11) in the reply filed on April 21st, 2026 is acknowledged.
Title of the Invention
The title of the invention is not descriptive of the claim limitations. Currently, the title recites “Vacuum Assisted Biopsy Device with Valve-Controlled Venting and Integrated Marker Delivery”. However, there is no recitation of “vacuum” or “valve-controlled venting” within the claims currently under examination. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “Marker Delivery Assembly”.
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.
Claims 1-11 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the preamble recites “[a] marker delivery assembly for a biopsy device ” in line 1. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). However, it is unclear as to whether the “biopsy device” is a part of the claimed invention or not, as the “biopsy device” is referenced numerous times, both in the independent claim and multiple dependent claims. Clarification is requested.
Claim 1 recites “an integration module comprising:” in line 2. Claim 1 later recites “a marker delivery module comprising:” in line 10. It is unclear as to what elements the “integration module” comprises, due to the current presentation of the claim limitations. It is unclear as to whether the “marker delivery module” is included in the “integration module”, or if these are two separate elements. In order to overcome this, Examiner suggests that the Applicant further clarify and indent the limitations that recite the elements that the “integration module” and “marker delivery module” each comprise of.
Claim 1 recites “forces at least one of the plurality of markers into the biopsy device” in line 20. It is unclear as to how at least one of the plurality of markers is forced into the biopsy device, as this is the first recitation of the “biopsy device” since the preamble. Although Claim 1 recites limitations regarding the connection between the marker delivery module and the integration module, there are no clear limitations regarding the connection to the “biopsy device”. The later recitations of the “biopsy device” in the dependent claims inherit but do not remedy this indefiniteness.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Haggar (U.S. Publication No. 2018/0168770) discloses a device and method for marking the location of a tissue biopsy. The device includes a needle with a proximal end, a distal end, a slot disposed adjacent the distal end, and a tip having an opening. The device further includes a handle coupled to the proximal end of the needle, and a cutting apparatus. The cutting apparatus includes a cutting mechanism disposed within the needle and adapted to remove tissue from a target area. The device further includes an ejector mechanism having an ejector rod disposed within the needle and an actuator disposed on the handle and operatively coupled to the ejector rod. The actuator is actuated to eject a marker disposed within the distal end of the needle through one or more of the slot or the opening to mark the location of the tissue biopsy.
Speeg et al (U.S. Publication No. 2011/0071431) discloses biopsy marker delivery devices and methods, wherein the biopsy device comprises a body portion having an alignment feature and a hollow biopsy needle extending distally from the body portion. The marker delivery device includes a marker deployer tube and an alignment feature associated with the marker deployer tube. The alignment feature on the marker delivery device is configured to matingly engage with the alignment feature on the biopsy device. A marker delivery device includes a resilient marker guide ramp.
Goldenberg (U.S. Publication No. 2006/0089564) discloses an aspiration needle with venting feature for collecting a specimen including an elongated hollow body that includes a first lumen portion and a second lumen portion. The first lumen portion is open at both ends for placement at a specimen site to collect and permit aspiration of the specimen from the specimen site. The second lumen has first and second vent ports, with the second vent port being formed along the elongated body such that that when the needle is placed at the specimen site, the second vent port is positioned at the specimen site. The first vent port is in fluid communication with atmospheric air when the needle is positioned at the specimen site so as to permit pressure within the specimen site to equilibrate with atmospheric pressure by means of the venting action of the second lumen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J YOON/Examiner, Art Unit 3791
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