DETAILED ACTION
1. This office action is in response to the communicated dated 04 June 2026 concerning application number 17/875,231 effectively filed on 27 July 2022.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of Claims
3. Claims 1-21 are pending, of which claim 1 has been amended; claims 12-21 have been withdrawn; and claims 1-11 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 04 June 2026, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive in view of the new grounds of rejection necessitated by Applicant’s amendments to the claims.
The Examiner has addressed the amended limitations within the updated text below.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1-2 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Vetter (US 2016/0089208 A1, referred to herein as “Vetter-208”) in view of Vetter et al. (US 2014/0358029 A1, referred to herein as “Vetter-029”).
Regarding claim 1, Vetter-208 teaches a surgical device (the biopsy device 10 comprises an operative head or cutting beak elements 13 that are configured to cut the target tissue [0065-0066, 0098-0099, FIG. 1]) comprising:
a body further comprising a proximal end and a distal end (the biopsy device 10 comprises a handle body 12 [0065, FIG. 1]. Specifically, figure 1 illustrates the handle body 12 of the device 10 having a proximal end and a distal end [FIG. 1]);
a hollow cannula extending from the distal end of the body (figure 1 illustrates the hollow cannula or transport tube assembly 11 extending distally from the handle body 12 of the biopsy device 10 [0065, FIG. 1]), the cannula further comprising a proximal end and a distal end (figure 1 illustrates the transport tube assembly 11 having a proximal end and a distal end [FIG. 1]);
an operative head positioned at the distal end of the cannula (figure 1 illustrates the operative head or cutting beak elements 13 being disposed at the distal end of the transport tube assembly 11 [0065, FIG. 1]); and
a suction connector in fluid communication with the hollow cannula (the severed tissue samples, cells, and fluids may be aspirated through the transport tube assembly 11 towards the suction connector or aspiration port 639 [0078, 0118, 0135, 0185, FIG. 1, FIG. 26A]. Specifically, the suction connector or aspiration port 639 is connected to a vacuum source that is configured to provide suction to transport the severed tissue, cells, and fluid into the storage magazine 27 [0078, 0138, FIG. 1, FIG. 26A]), the suction connector being configured for connection to a suction source (the suction connector or aspiration port 639 is configured to be connected to a vacuum source [0078, FIG. 1, FIG. 26A]);
wherein the hollow cannula further comprises rifling on at least a portion of an inside surface (the inner lumen or inner surface of the transport tube assembly 11 may include a rifling that is configured to be rotated to help transport the severed tissue through the transport tube assembly 11 [0185]);
wherein the at least one of the diverters and the rifling is configured to induce rotation of fluid, tissue, and debris passing through the hollow cannula to reduce adherence of the fluid, tissue, or debris to the inside surface of the hollow cannula (the inner lumen or inner surface of the transport tube assembly 11 may include a rifling that is configured to be rotated to help transport the severed tissue through the transport tube assembly 11 [0185]. The Examiner respectfully submits that the severed tissue does not adhere to the transport tube assembly 11, as the rifling is rotated to transport the severed tissue through the transport tube assembly 11 [0185]).
Although Vetter-208 teaches the rifling positioned inside the hollow cannula (see the explanation above), Vetter-208 does not explicitly teach the rifling positioned at a location proximal to the operative head and proximal to the distal end of the hollow cannula.
The prior art by Vetter-029 is analogous to Vetter-208, as they both a biopsy device comprising cutting beak elements that are configured to cut or sever a target tissue ([0085, 0089, 0096]).
Vetter-029 teaches wherein the rifling is positioned inside the hollow cannula at a location proximal to the operative head and proximal to the distal end of the hollow cannula (figure 3 illustrates the hollow cannula or transport tube assembly 25 having a proximal end and a distal end [0091, 0093, FIG. 3]. Specifically, figure 3 illustrates the operative head or cutting beak elements 13 extending from the distal end of the hollow cannula or transport tube assembly 25 [0091, 0093, FIG. 3]. Furthermore, the hollow cannula or transport tube assembly 25 comprises an internal rifling 160 that is defined throughout the internal lumen wall of the transport tube assembly 25 [0112, 0118, 0123, FIG. 3, FIGS. 33-34]. In other words, the internal rifling 160 extends through the internal lumen of the transport tube assembly 25 (e.g., hollow cannula) from the proximal end to the distal end [0118, 0123, FIG. 3, FIGS. 33-34]. The Examiner respectfully submits that the internal rifling 160 extends to the distal end of the transport assembly tube 25 which is proximal to the operative head or cutting beak elements 13 [FIG. 3, FIGS. 33-34, 0091, 0118, 0123]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Vetter-208’s rifling to be positioned at location within the hollow cannula that is proximal to the operative head and proximal to the distal end of the hollow cannula, as taught by Vetter-029. This modification is beneficial, as the rifling will be positioned to enhance the transportation of the severed tissue throughout the hollow cannula (e.g., transport tube assembly 25) (see paragraphs [0112, 0118, 0123] by Vetter-029).
Regarding claim 2, Vetter-208 teaches wherein the operative head further comprises a radio frequency ablator (the cutting beak elements 13 comprises cutting surfaces that energized by radio-frequency ablation energy [0065, 0072]).
Regarding claim 10, Vetter-208 in view of Vetter-029 suggests the surgical device of claim 1. Vetter-208 teaches wherein the hollow cannula comprises rifling on at least a portion of an inside surface (the inner lumen or inner surface of the transport tube assembly 11 may include a rifling that is configured to be rotated to help transport the severed tissue through the transport tube assembly 11 [0185]); and
Vetter-029 teaches wherein the rifling is in a helical pattern (the internal rifling 160 is defined throughout the internal lumen of the hollow cannula or transport tube assembly 25 [0123]. Additionally, the oversized helical elements 170 may be provided within the inner lumen of the transport tube assembly 25 [0123, 0126]. Specifically, the oversized helical elements 170 may serve as an additional rifling structure within the inner lumen [0126]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the rifling suggested by Vetter-208 in view of Vetter-029 to be in a helical pattern, as further taught by Vetter-029. This modification is beneficial, as the helical pattern of the rifling is rotated to improve longitudinal or axial movement of the tissue throughout the hollow cannula (e.g., transport tube assembly 25) (see paragraph [0126] by Vetter-029).
Regarding claim 11, Vetter-208 in view of Vetter-029 suggests the surgical device of claim 1. Vetter-208 teaches wherein the hollow cannula comprises rifling on at least a portion of an inside surface (the inner lumen or inner surface of the transport tube assembly 11 may include a rifling that is configured to be rotated to help transport the severed tissue through the transport tube assembly 11 [0185]); and
Vetter-029 teaches wherein the rifling is in a helix pattern (the internal rifling 160 is defined throughout the internal lumen of the hollow cannula or transport tube assembly 25 [0123]. Additionally, the oversized helix or helical elements 170 may be provided within the inner lumen of the transport tube assembly 25 [0123, 0126]. Specifically, the oversized helix or helical elements 170 may serve as an additional rifling structure within the inner lumen of the transport tube assembly 25 [0126]).
Vetter-208 and Vetter-029 do not explicitly teach the helix pattern of rifling to be in a double helix pattern.
The Examiner respectfully submits as Vetter-029 teaches the rifling in a helix pattern (the oversized helix or helical elements 170 may serve as a rifling structure within the inner lumen of the transport tube assembly 25 [0126]), configuring the rifling to form a double helix pattern would be a matter of changing the shape of the known element without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the rifling suggested by Vetter-208 in view of Vetter-029 to be in a double helix pattern, as further suggested by Vetter-029. This modification is beneficial, as the helix or helical pattern of the rifling is rotated to improve longitudinal or axial movement of the tissue throughout the hollow cannula (e.g., transport tube assembly 25) (see paragraph [0126] by Vetter-029).
Allowable Subject Matter
7. Claims 3-9 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: The Examiner has provided an explanation below that describes how the prior art of record fails to suggest the corresponding claims.
Regarding claim 3, Vetter-208 in view of Vetter-029 suggests the surgical device of claim 1. Vetter-208 teaches wherein the operative head further comprises cutting elements (the cutting beak elements 13 [0065]).
However, Vetter-208 and Vetter-029 do not explicitly teach wherein the operative head further comprises diverters on at least a portion of an inside surface. The Examiner respectfully submits that modifying Vetter-208’s operative head (cutting beak elements 13) to include diverters on an inside surface would require a structural redesign of the operative head. Thus, Vetter-208 and Vetter-029 do not explicitly suggest the claimed limitation.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 4, Vetter-208 in view of Vetter-029 suggests the surgical device of claim 1. Vetter-029 teaches the rifling extending through the hollow cannula (the hollow cannula or transport tube assembly 25 comprises an internal rifling 160 that is defined throughout the internal lumen wall of the transport tube assembly 25 [0112, 0118, 0123, FIG. 3, FIGS. 33-34]).
However, Vetter-208 and Vetter-029 do not explicitly teach wherein the operative head further comprises rifling on at least a portion of an inside surface.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 5, Vetter-208 in view of Vetter-029 suggests the surgical device of claim 1. Vetter-208 and Vetter-029 do not explicitly teach wherein the body further comprises a suction bore extending from the suction connector to a position near the hollow cannula, the suction bore being in fluid communication with the suction connector and the hollow cannula; and wherein the suction bore further comprises diverters along at least a portion of an inside surface.
The prior art by DeCesare (US 2005/0277915 A1) is analogous to Vetter-208, as they both teach a device that provides suction to collect aspirated tissue and fluids ([0036]).
DeCesare teaches wherein the body further comprises a suction bore (extension tubing 36 [0036-0037, FIG. 1]) extending from the suction connector to a position near the hollow cannula (the suction connector or port 32 is coupled to an extension tubing 36 which provides a fluid connection between the port 32 of the aspirator 14 and the probe 40 of the electrosurgical instrument 10 [0036-0037, 0050, FIG. 1]. For example, the probe 40 comprises a cannula or tubing 48 defining a hollow lumen 58 that is in fluid communication with the port 32 of aspirator 14 via the extension tubing 36 [0036-0037, 0050, FIGS. 1-2, FIG. 4]).
Vetter-208, Vetter-029, and DeCesare do not explicitly teach wherein the suction bore further comprises diverters along at least a portion of an inside surface.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 6, Vetter-208 in view of Vetter-029 suggests the surgical device of claim 1. Vetter-208 and Vetter-029 do not explicitly teach wherein the body further comprises a suction bore extending from the suction connector to a position near the hollow cannula, the suction bore being in fluid communication with the suction connector and the hollow cannula; and wherein the suction bore further comprises rifling along at least a portion of an inside surface.
However, DeCesare teaches wherein the body further comprises a suction bore (extension tubing 36 [0036-0037, FIG. 1]) extending from the suction connector to a position near the hollow cannula (the suction connector or port 32 is coupled to an extension tubing 36 which provides a fluid connection between the port 32 of the aspirator 14 and the probe 40 of the electrosurgical instrument 10 [0036-0037, 0050, FIG. 1]. For example, the probe 40 comprises a cannula or tubing 48 defining a hollow lumen 58 that is in fluid communication with the port 32 of aspirator 14 via the extension tubing 36 [0036-0037, 0050, FIGS. 1-2, FIG. 4]).
Vetter-208, Vetter-029, and DeCesare do not explicitly teach wherein the suction bore further comprises rifling along at least a portion of an inside surface.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 7, Vetter-208 in view of Vetter-029 suggests the surgical device of claim 1. Vetter-029 teaches the rifling extending through the hollow cannula (the hollow cannula or transport tube assembly 25 comprises an internal rifling 160 that is defined throughout the internal lumen wall of the transport tube assembly 25 [0112, 0118, 0123, FIG. 3, FIGS. 33-34]).
However, Vetter-208 and Vetter-029 do not explicitly teach wherein the wherein the hollow cannula comprises diverters on at least a portion of an inside surface and wherein the diverters further comprise a round profile.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 8, Vetter-208 in view of Vetter-029 suggests the surgical device of claim 1. Vetter-029 teaches the rifling extending through the hollow cannula (the hollow cannula or transport tube assembly 25 comprises an internal rifling 160 that is defined throughout the internal lumen wall of the transport tube assembly 25 [0112, 0118, 0123, FIG. 3, FIGS. 33-34]).
However, Vetter-208 and Vetter-029 do not explicitly teach wherein the hollow cannula comprises diverters on at least a portion of an inside surface and the diverters are in a helical pattern.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 9, Vetter-208 in view of Vetter-029 suggests the surgical device of claim 1. Vetter-029 teaches the rifling extending through the hollow cannula (the hollow cannula or transport tube assembly 25 comprises an internal rifling 160 that is defined throughout the internal lumen wall of the transport tube assembly 25 [0112, 0118, 0123, FIG. 3, FIGS. 33-34]).
However, Vetter-208 and Vetter-029 do not explicitly teach wherein the hollow cannula comprises diverters on at least a portion of an inside surface and the diverters are in a double helix pattern.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Conclusion
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art by Vetter (US 2013/0096459 A1) is analogous to Applicant’s disclosure, as Vetter teaches a rifling structure that is configured induce rotation of tissue ([0073]).
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 JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
Prosecution Insights