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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-19 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 11-19 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 11, the limitation “the housing defining a wall separating the probe from the tissue sample holder with penetrations through the wall for the cutter, and the penetrations through the wall also being for vacuum communication which is adjacent to the cutter and between the tissue sample holder and the vacuum reservoir” renders the claims indefinite.
The claim states “…penetrations [plural] through the wall… which is [singular] adjacent to the cutter…” and it is unclear what the clause “which is adjacent to the cutter” modifies. Does it modify “penetrations” (if so, the verb should be “are” … which “are adjacent”)? Does it modify “vacuum communication” (if so, the relationship between the “vacuum communication” and “the cutter” is unclear, because it is not understood how “vacuum communication” can be adjacent something). The examiner cannot determine if the claim is setting forth physical holes that are adjacent the cutter or if some sort of airflow is adjacent the cutter. For purposes of examination the indefinite limitation has been deemed to claim that either the cutter and some sort of airflow/vacuum flow are capable of running through a hole/opening in the wall.
The claim further states the penetrations are “for the cutter”, which is being interpreted as holes that are in the wall for the cutter to pass through. However, the claim also states that the vacuum communication (or penetrations) is “adjacent to the cutter”. This claim language creates a some sort of logical conflict regarding the relationship between the penetrations, the cutter, and the vacuum communication because it is unclear if the cutter goes through the hole and the vacuum goes through a gap around the cutter (if so, adjacent is a poor descriptor for surrounding a gap) or if there are distinct holes for each of the cutter and the vacuum (if the, the claim language “the penetrations… for the cutter… also being for vacuum” is misleading because it implies that the same penetrations before both functions). For purposes of examination the indefinite limitation has been deemed to claim where the wall has a hole where both a cutter and airflow/vacuum flow are capable existing within.
Overall, the relative function and position of the penetrations in the wall with respect to the cutter and the vacuum communication are unclear.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20110208086 A1 to Hibner et al. (hereinafter, Hibner).
Regarding Claim 1, Hibner discloses a probe of a biopsy device (10; FIGS. 1-6), the biopsy device having a tissue sample holder defining a sample chamber (structure defining 45 which is nested within 44, as shown below in annotated FIG. 4) and a holster (14) removably secured to the probe (FIGS. 2 and 3), the biopsy device defining a flowpath (flowpath defined by space within elements beginning generally around 21/22/24/50 and entering 45 before ending at 44), the probe comprising inter alia:
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a cannula (21); and
a housing (combination of both 12 and 44) defining a vacuum chamber within the housing (a vacuum “chamber” is created within 44 via vacuum pump 38 by way of ports 39 and 47, para. [0036] “… 44… is in fluid communication with… vacuum pump…”; and 12 is also considered a vacuum chamber, because it is a “chamber” that holds elements that define the flowpath that receive vacuum pressure), the vacuum chamber (44) being in communication with the sample chamber of the tissue sample holder (45) (44 is in communication 45 via the defined flowpath; and 12 is in communication with 45 because 45 exists within 12), the cannula passing through the vacuum chamber (45 is within both 12 and 44, FIGS. 4 and 5), the flowpath extending from starting at the cannula, continuing from the cannula to the sample chamber, and then to ending at the vacuum chamber (flowpath defined by space within elements beginning generally around 21/22/24/50 and entering 45 before ending at 44), wherein tissue is configured to contact at least the cannula and the sample chamber by following at least a portion of the flowpath (tissue moves and contacts the flowspace within the space within elements beginning generally around 21/22/24/50 and entering 45 before ending at 44).
Regarding Claim 2, Hibner discloses the probe of claim 1, further comprising a cutter (50) for severing a tissue sample, the cutter extending through the vacuum chamber (50 enters 12; FIG. 5) and is in communication with the tissue sample holder (50 is in communication with 45 via the flowpath).
Regarding Clam 3, Hibner discloses the probe of claim 1, further comprising a cutter drive (60) and a cutter (50) for severing a tissue sample, the cutter drive being configured to translate and rotate the cutter (para. [0046]), the cutter drive and the cutter being both partially disposed within the vacuum chamber (50 and 60 are both located within 12).
Regarding Claim 4, Hibner discloses the probe of claim 1, the vacuum chamber (combination of 44 and 12) including four fluid reservoirs separated by a plurality of internal walls (various protruding internal walls that extend within 44, annotated FIG. 4, below).
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Regarding Claim 5, Hibner discloses the probe of claim 1, the vacuum chamber including a plurality of fluid reservoirs separated by one or more internal walls extending within the probe axially, laterally, or a combination thereof (various protruding internal walls that extend within 44, annotated FIG. 4, below).
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Regarding Claim 6, Hibner discloses the probe of claim 1, the vacuum chamber defining a first volume being greater than a second volume defined by the tissue sample holder (volume within 44 is significantly larger than volume within 45, FIG. 3).
Regarding Claim 8, Hibner discloses the probe of claim 1, the housing of the probe including an upper housing (14) and a lower housing (12) coupled together and defining an interface, the interface being absent of hard edges (FIGS. 1 and 2).
Regarding Claim 9, Hibner discloses the probe of claim 1, the housing of the probe including an upper housing (14) and a lower housing (12) coupled together and defining an interface (FIGS. 1 and 2), the lower housing including a taper to thereby be self-centering relative to the upper housing (see tapering of 14 in FIG. 1).
Regarding Claim 10, Hibner discloses the probe of claim 1, further comprising a first gear (86 and 88) and a second gear (122) rotatably connected by a shaft (252), the first gear being exposed relative to an exterior of the housing (FIG. 2), the second gear being disposed within the vacuum chamber (within 12) and is sealed relative to the exterior of the housing by a seal (120) engaged with the shaft (para. [0048]).
Regarding Claim 11, Hibner discloses a handheld tetherless biopsy device for collecting one or more tissue samples, the biopsy device comprising inter alia:
a holster (14) having a motor (36) and a vacuum pump (38) coupled to the motor (via 62, 72, 74, etc.);
a probe (12) removably coupled to the holster, the probe including a housing (combination of both 12 and 44) having a vacuum port (47) in communication with the vacuum pump of the holster (via 39; FIG. 5), the housing defining a vacuum reservoir (44) in communication with the vacuum port (47 is part of 44);
a cutter (50) for severing a tissue sample; and
a tissue sample holder (45) defining a sample chamber configured to receive tissue samples therein (tissue that moves along flowpath defined by space within elements beginning generally around 21/22/24/50 and entering 45 before ending at 44), the sample chamber (45) being in communication with the vacuum reservoir of the probe (flowpath defined by space within elements beginning generally around 21/22/24/50 and entering 45 before ending at 44), the housing defining a wall separating the probe (12) from the tissue sample holder (44) with penetrations through the wall for the cutter, and the penetrations through the wall also being for vacuum communication which is adjacent to the cutter and between the tissue sample holder and the vacuum reservoir (as seen below in annotated FIG. 5, where the penetrations in 12 allow for the cutter to enter 12 and also allow vacuum communication, because without the penetrations, there could be no vacuum communication to the tissue sample holder and the vacuum reservoir, because the cutter would not exist within 12).
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Regarding Claim 12, Hibner discloses the biopsy device of claim 11, the vacuum reservoir including a plurality of reservoirs separated by one or more internal walls (various protruding internal walls that extending within 44, annotated FIG. 4, below) and interconnected by an opening disposed within each of the one or more internal walls (openings within 46), or (alternative interpretation or in combiantion) the vacuum reservoir including a plurality of reservoirs (120, 204, 212, FIG. 3) separated by one or more internal walls (distal and proximal most end walls of 120, 204, 212) and interconnected by an opening disposed within each of the one or more internal walls (openings at proximal and distal ends of 120, 204, 212).
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Regarding Claim 13, Hibner discloses the biopsy device of claim 11, the probe further including a cutter drive (60) configured to translate and rotate the cutter (para. [0046]), at least a portion of the cutter and the cutter drive being disposed within the vacuum reservoir (50 and 60 are both located within 12).
Regarding Claim 14, Hibner discloses the biopsy device of claim 12, the probe further including a cutter drive (60), the cutter drive being configured to translate and rotate the cutter (para. [0046]), at least a portion of the cutter and the cutter drive being disposed within the vacuum reservoir (50 and 60 are both located within 12), the opening of at least one of the one or more internal walls being configured to receive the cutter (each of 120, 204, 212 receive cutter 50) and a portion of the cutter drive (cutter drive 60 is received by 100, which is part of 120) while providing fluid flow between two fluid reservoirs of the plurality of reservoirs (via distal to proximal flowpath).
Regarding Claim 15, Hibner discloses the biopsy device of claim 11, the probe further including a valve assembly (150) configured to provide selective ventilation to a portion of the probe (para. [0077] “During this time, second lumen (28) may be vented by valve mechanism (150).”), the valve assembly being fluidly isolated from the vacuum reservoir (between 150 and 44, there are elements 212 and 54, and also the physical wall of the cutter, which broadly fluidically isolate 150 from 44).
Regarding Claim 16, Hibner discloses the biopsy device of claim 11, the probe further including a vent chamber (204 which defines hollow interior 206) and a valve assembly disposed within the vent chamber and configured to provide selective ventilation to a portion of the probe, the vent chamber being fluidly isolated from the vacuum reservoir (between 150 and 44, there are elements 212 and 54, and also the physical wall of the cutter, which broadly fluidically isolate 150 from 44).
Regarding Claim 17, Hibner discloses the biopsy device of claim 11, the probe further including a valve assembly (42, 48, 53) configured to provide selective ventilation to a portion of the probe, the valve assembly being fluidly isolated from the vacuum reservoir while also being disposed within a portion of the vacuum reservoir (42 is disposed in 44, acts as a manual valve by maintaining vacuum and being removed to retrieve tissue, and serves as a boundary interface between the interior of 44 and the external environment).
Regarding Claim 19, Hibner discloses the biopsy device of claim 11, the housing of the probe including a first housing (14) and a second housing (12), the first housing and the second housing being configured to couple together to seal the vacuum reservoir relative to an exterior of the probe (FIGS. 1 and 2).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hiber.
Hibner discloses a biopsy device (10; FIGS. 1-6) having an internal vacuum (a “internal” vacuum is created directly within 44 via vacuum pump, para. [0036] “… 44… is in fluid communication with… vacuum pump…”; and 12 is also considered to have an “internal” vacuum, because it internally holds elements that receive vacuum pressure) and comprising a probe (21), a holster (14) removably secured to the probe (FIGS. 2 and 3), and a tissue sample holder defining a sample chamber (45), the probe comprising inter alia:
a housing (combination of both 12 and 44) defining a vacuum chamber within the housing (a vacuum “chamber” is created directly within 44 via vacuum pump, para. [0036] “… 44… is in fluid communication with… vacuum pump…”; and 12 is also considered a vacuum chamber, because it is a “chamber” that holds elements that receive vacuum pressure), the vacuum chamber (44) having an opening for communication with the sample chamber (45) of the tissue sample holder (44 and 45 are open to one another to define the flowpath, therefore, they have “an opening” for communication to one another);
a cutter (50) for severing a tissue sample, the probe defining a flowpath starting at the cutter, continuing from the cutter to the sample chamber, and continuing from the sample chamber to the vacuum chamber (flowpath defined by space within elements beginning generally around 21/22/24/50 and ending at 44); and
a cutter drive (60), the cutter drive being configured to translate and rotate the cutter (para. [0046]), the cutter and the cutter drive being both partially disposed within the vacuum chamber (50 and 60 are both located within 12).
Hibner does not expressly disclose in the embodiment of FIGS. 1-6 that the biopsy device vacuum is an internal source of vacuum. However, in an alternative embodiment, Hibners teaches at para. [0067] that biopsy device housing can be integrated with a direct internal vacuum souce. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the biopsy device 10 to have an integrated vacuum source, as Hibner teaches at para. [0067] that this would have been apparent to those of ordinary skill in the art. This source would have obviously been at the end of the flow path (proximal portion of the housing), to allow for the flowpath to remain as they intended and to properly collect tissue.
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hibner.
Regarding Claims 7 and 18, Hardin disclose the biopsy device of claims 1 and 11 except for expressly disclosing the vacuum chamber defining a first volume of about 175 cc, the first volume being 10 to 20 times greater than a second volume defined by the tissue sample holder. However, one having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the first volume to be about 175 cc and be 10 to times greater than a second volume, because such sizes would would have been any number of vacuum volume sizes a skilled artisan would choose to have influences the vacuum to operate in a variety of configurations.
Conclusion
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