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 of Group II in the reply filed on July 29th, 2026 is acknowledged. Because the Applicant did not specify whether the election was made with traverse or not, the Examiner will assume that the election of Group II was made without traverse.
Claims 2-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 29th, 2026.
Applicant's election with traverse of Species F and I in the reply filed on July 29th, 2026 is acknowledged. The traversal is on the ground(s) that the Examiner has not established a prima facie showing that there would be a serious search and/or examination burden. This is not found persuasive because the species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. In addition, these species are not obvious variants of each other based on the current record.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13 and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 29th, 2026.
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract fails to include essential components of the claimed invention, such as the “imaging unit including an imaging device”, “biopsy device”, and “tube line”. The abstract seems to be an exact copy of the abstract used for the parent application (Application No. 16/609,350), but the scopes of these two applications are different. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “tube line” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Furthermore, the reference character "60" is used to designate “biopsy excision tool” in the Specification while the Drawings and Claims use the term “biopsy device”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12, 14-15, and 18-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12 recites “tube line” in line 4. However, the Applicant’s Specification does not disclose the term “tube line”. Although the Applicant’s Specification recites an “inlet tube 46” and a “suction tube 48”, it is unclear as to whether the “tube line” is referring to one of those elements, both of those elements, or a completely separate element. The dependent claims inherit but do not remedy the deficiencies of Claim 12.
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 12, 14-15, and 18-24 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.
Claim 12 recites the limitation "the first tissue storage compartment" in line 20. There is insufficient antecedent basis for this limitation in the claim. It is unclear as to whether this element is referring to the previously introduced “first storage compartment of the plurality of tissue compartments” from lines 17-18 of Claim 12, or a separate element.
Claim 12 recites “in an imaging position above the raised surface of the base” in lines 20-21. It is unclear as to how the tissue holder would be able to position the compartment “above” the raised surface of the base through rotation. The rotation of the tissue holder is around a longitudinal axis; thus, it is unclear as to how the rotation can accomplish a vertical adjustment.
Claim 15 recites “a sector shape” in line 5. It is unclear as to whether this element is referring to the previously introduced “sector shape” of Claim 12, or a separate element.
Claim 23 recites “circumferentially aligned” in line 2. It is unclear as to what element the “vaulted compartment” is circumferentially aligned with.
Claim 24 recites the limitation "the vaulted compartment" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner notes that Claim 24 is dependent on Claim 19, which is dependent on Claim 12, and neither Claim 12 nor 19 recites a “vaulted compartment”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Axon (U.S. Publication No. 2019/0054217) teaches a device for separation and collection of tissue (Abstract), comprising: a base member having a bottom member and a cylindrical sidewall (Base member 2 includes a generally planar circular wall forming a lower wall 2 a of the device, which cooperates with the wall 12 and upper wall 1 a to form a housing which, when assembled, is closed with the exception of the inlet aperture 6 a and outlet aperture 7 a; [0088]), a cover (The lid member 1 includes a generally planar circular upper wall with a bevelled lateral portion which together form an upper wall 1 a of the device, and from which depends an annular flange 10; [0086]), and a tissue holder defining a plurality of tissue storage compartments (four recessed portions 15 which, as further described below, act in use as filter receptacles selectively usable in series to collect up to four separate tissue samples; [0087]).
Parks (U.S. Patent No. 8,465,439) teaches a tissue collection and separation device (Abstract), comprising a cylindrical container (tissue collection container 24) having a bottom member and a cylindrical side wall (the tissue collection container 24 is substantially cylindrically shaped. As shown in FIGS. 1-6, the tissue collection container 24 comprises a substantially cylindrical side wall 21 and a circular bottom wall 22 formed on the lower periphery thereof; Column 5 Lines 57-61), a rotatable cover (cover 26 may be attached to container 24 by friction-fit or screw on, but is preferably attached by snap-on in a manner that permits rotational movement relative to one another; Column 5 Lines 9-12), and a tissue holder that is fit with a sector shaped projection (this projection 64 is narrow so as to fit in between the respective side walls 46, 48 of adjacent tissue collection baskets 38. In another embodiment, as shown in FIG. 7B, this projection 64 is wedge shaped so as to fit within the cross sectional area of the tissue collection baskets 38. As this projection 64 rubs against the upper edge of each side wall 46,48 of a tissue collection basket 38, it causes a bumping feeling to the user who is rotating the cover 26 with respect to the tissue collection container 24; Column 9 Line 63 – Column 10 Line 5).
Nock et al (U.S. Publication No. 2016/0081676) teaches an MRI biopsy system (Abstract), comprising: a biopsy device, a MRI system (Biopsy device (14) is positioned and guided by localization fixture (16) attached to breast coil (18) that may be placed upon a gantry (not shown) of a MRI or other imaging machine; [0080]), and a manually rotatable tissue sample holder (Thumbwheel (1530) is configured to enable an operator to engage thumbwheel (1530) and thereby rotate needle assembly (1520) about the longitudinal axis of needle assembly (1520), relative to housing (1512); [0204]).
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.
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, 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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