DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the rejection of the claims as set forth in the Non-Final rejection filed 4/28/2026 have been fully considered, are persuasive, and are withdrawn. New grounds of rejection are presented for Claims 1-10.
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 1-10 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.
Regarding Claim 1, the specification as originally filed did not have possession of where the cannula extends through the vacuum chamber and the vacuum chamber being in contact with an outside surface of the cannula. In the instant invention, the cannula 120 appears to stay at the distal needle portion and does not extend back through the vacuum reservoir. The disclosure supports the cutter extending through the vacuum chamber and the vacuum chamber being in contact with an outside surface of the cutter, but not the cannula.
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 1-10 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, it appears the claim incorrectly sets forth that the cannula extends through the vacuum chamber and the vacuum chamber being in contact with an outside surface of the cannula. For purposes of examination the indefinite limitation has been deemed to claim that it is the cutter that extends through the vacuum chamber and the vacuum chamber being in contact with an outside surface of the cutter.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 2 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20130197394 A1 to Mark et al. (hereinafter, Mark).
Regarding Claim 1, Mark discloses a probe (300) of a biopsy device (200’), the biopsy device having a tissue sample holder defining a sample chamber (308) and a holster (358 which is moveable e.g., removably secured to probe 300) removably secured to the probe, the biopsy device defining a flowpath (aperture 336 -> inner lumen 346 -> vacuum inlet 340 -> vacuum chamber 306 -> port 302/channel 304 -> reservoir 308), the probe comprising inter alia:
a cannula (316); and
a housing (306 and 352) defining a vacuum chamber (space within vacuum chamber 306) within the housing (paragraph [0087] “…a vacuum is generated in the vacuum chamber 306…”),
the vacuum chamber being in communication with the sample chamber of the tissue sample holder (via 304), the cannula extending through the vacuum chamber (see FIGS. 29A-C), the flowpath starting at the cannula, continuing from the cannula to the sample chamber, and ending at the vacuum chamber (aperture 336 -> inner lumen 346 -> vacuum inlet 340 -> vacuum chamber 306 -> port 302/channel 304 -> reservoir 308), wherein tissue is configured to contact at least the cannula and the sample chamber by following at least a portion of the flowpath (tissue is drawn into the aperture 336 and flows into reservoir 308), wherein the flowpath from the sample chamber to the vacuum chamber is in contact with an outside surface of the cannula (e.g., the vacuum runs from reservoir 308 into chamber 306, which surrounds cannula 316 and is sealed at its outer surface by 352 and reaches the lumen via inlet 340 – so the flowpath contacts the outside surface of 316 across the chamber).
Regarding Claim 2, Mark discloses the probe of claim 1, further comprising a cutter for severing a tissue sample, the cutter extending through the vacuum chamber and is in communication with the tissue sample holder (see FIGS. 29A-C).
Regarding Claim 8, Mark discloses the probe of claim 1, the housing of the probe including an upper housing and a lower housing coupled together and defining an interface, the interface being absent of hard edges (see FIGS. 29A-C; e.g., the top and bottom of the device as seen in the figures).
Allowable Subject Matter
Claims 3-7, 9 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 11 and respective dependent claims are allowable over the prior art of record. The prior art of record fails to disclose a holster having a motor and a vacuum pump coupled to the motor, a housing defining at least one wall separating the probe from the tissue sample holder with at least one penetration through the at least one wall for the cutter to pass therethrough, and the at least one penetration through the at least one wall also being for vacuum communication, the vacuum communication extending through the at least one penetration for the vacuum communication to thereby be adjacent to an outside surface of the cutter and between the tissue sample holder and the vacuum reservoir.
Claim 21 and respective dependent claims are allowable over the prior art of record. The prior art of record fails to disclose the flowpath from the sample chamber to the vacuum chamber being in contact with an outside surface of the cutter; and a cutter drive, the cutter drive being configured to translate and rotate the cutter, the cutter and the cutter drive being both partially disposed within the vacuum chamber.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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