DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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 2, 3, 8, 10, 11, 17, 19-21 and 25 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 Claims 2, 3, 8, 17, 19-21 and 25, the limitation “wherein when the delivery sleeve is in an installed condition, the outer cannula is disposed in the outer channel and in communication with the at least one delivery channel along the length of the delivery sleeve.” The term “in communication” in claims 7, 21 and 25 is a relative term which renders the claim indefinite. The term “in communication” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Due to the definition of “in communication” lacking within the claims and specification, the relationship between the outer cannula disposed in the outer channel and the delivery channel is unclear. It is not understood how the outer cannula can “communicate” with the delivery channel when it is located within the outer cannula channel in the installed condition. For purposes of examination the indefinite limitation has been deemed to claim that the outer cannula channel and the delivery channel are in fluid communication with each other in at least one of the installed and uninstalled condition.
Regarding Claim 10, the limitation “wherein a distal end of the deliver sleeve, when affixed to the tissue removal instrument” renders the claim indefinite. As set forth in Claim 9, the deliver sleeve is claimed as part of the tissue removal instrument (i.e., “a tissue removal instrument comprising: … a deliver sleeve…”, therefore, it is unclear how the delivery sleeve is in fact attached to itself as set forth in Claim 10. For purposes of examination the indefinite limitation has been deemed to claim that the tissue removal instrument entails the handpiece and the outer cannula, and where the deliver sleeve is a separate instrument that is placed about the tissue removal instrument.
Regarding Claims 11, 17, 21 and 25, the limitations “installed” and “uninstalled” and their respective claim language in regards to the delivery channel and the outer cannula channel render the claim indefinite. Para. [0118] sets forth that when the delivery sleeve is in the uninstalled condition (i.e., the cannula is not in the cannula channel) the delivery channel and the cannula channel are in fluid communication, but when the delivery sleeve is in the installed condition (i.e., the cannula is inserted into the cannula channel), the delivery channel and the cannula channel are separated. However, Claims 11, 17, 21 and 25 say just the opposite - that is the uninstalled condition the channels are separated and with in the installed condition the channels are in some sort of communication. Therefore, claim limitations are indefinite as it is unclear what is entails “installed” and “uninstalled” and how the cannula effects the communication between each channel. For purposes of examination the indefinite limitation has been deemed to claim the interpretation as set forth in paragraph [0118] to suggest that the cannula blocks the communication between each channel.
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 2, 3, 6-11, 13-15, 17, 19, 20-23 and 25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 20060074342 A1 to Hibner in view of US 5954670 A to Baker.
Regarding Claims 6, 7, 9-11, 13-15 and 21, Hibner discloses a tissue removal system (Abstract “A biopsy device and method are provided for obtaining tissue samples.”), comprising inter alia:
a tissue removal instrument comprising:
a handpiece (handpiece 30); and
an outer cannula (cannula 82) having an outer cannula lumen (upper cutter lumen 83), a proximal end (proximal most end of cannula 82 seen in FIG. 4), a closed distal end (closed via endpiece 90), and an outer cannula opening proximate the closed distal end (tissue receiving port 86), wherein the opening defines an edge for severing tissue (the defined perimeter of tissue receive port 86 is an edge that is capable of serving tissue, especially in tandem with cutter 100), and wherein the tissue removal instrument is configured to deliver vacuum to the outer cannula (via vacuum source 36) (para. [0085] “Lateral vacuum force 176 can be employed in combination with an axial vacuum force 180 through cutter lumen 104 to draw a tissue sample 182 into tissue port 86.”);
(Claim 7) wherein the tissue removal instrument includes an inner cannula (cutter 100) disposed in the outer cannula lumen (para. [0072] “…an upper cutter lumen 83 for receiving a cutter 100 (as shown in FIG. 5a)…”) and is-reciprocal within the outer cannula lumen (para. [0075] “The cutter 100… can be supported for translation and rotation within lumen 83.”), the inner cannula having an inner cannula lumen (lumen 104), a proximal end (at cutter gear 110), and an open distal end (distal end 106), and a cutting edge at the inner cannula distal end (para. [0075] “Cutter 100 can have a sharpened distal end 106 for cutting tissue…”); and
(Claims 6 and 13) wherein the level of vacuum is variable, wherein the handpiece includes a user interface for controlling the level of vacuum (para. [0084] “Microprocessor 49 can be employed to activate valve 48 to supply vacuum force 176 when switch 64 is actuated by the user…”).
Hibner discloses the claimed invention except for expressly disclosing: (Claim 9) a delivery sleeve disposed about the outer cannula, wherein the delivery sleeve comprises an outer cannula channel and at least one delivery channel, (Claim 10) wherein a distal end of the delivery sleeve, when affixed to the tissue removal instrument, is in parallel alignment to the distal end of the outer cannula, (Claim 11) wherein when the delivery sleeve is in an uninstalled condition, the at least one delivery channel is separated from the outer cannula channel along the a length of the delivery sleeve, (Claim 14) wherein the delivery sleeve is removable from the outer cannula at the distal end of the outer cannula, (Claim 15) wherein the outer cannula is rotatable with respect to the delivery sleeve and the handpiece, and (Claim 21) wherein when the delivery sleeve is in an installed condition, the outer cannula is disposed in the outer cannula channel and in communication with the at least one delivery channel along a length of the delivery sleeve.
However, Baker teaches a biopsy guide device (biopsy guide device 20) that includes a plurality of channels (cannula 22 including lumen 26 and cannula 24 including lumen 27), where one channel is used to guide a biopsy device (cannula 22 including lumen 26, col. 6, lines 19-25) to a target area and where an additional channel (cannula 24 including lumen 27 of Baker, col. 6, lines 19-25). Additionally, in an alternative embodiment, there are two channels that are in fluid communication with one another along their length (FIG. 4E and col. 8, lines 29-32). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the outer cannula of Hibner the be disposed within the cannula 22 of the multiple channeled delivery sleeve of Baker, as Baker teaches at col. 4, lines 12-29 that the biopsy guide device (e.g., the claimed delivery sleeve) would have eliminated the need for expensive stereotactic equipment and further teaches at col. 4, lines 45-54 that the biopsy guide device (e.g., the claimed delivery sleeve) would have allowed confident positioning of the biopsy device within the target area.
The combination of Hibner and Baker (e.g., placing the claimed outer cannula of Hibner within cannula 22 of Baker) would have predictably yielded:
(Claim 9) a delivery sleeve (biopsy guide device 20 of Baker) disposed about the outer cannula (cannula 82 of Hibner), wherein the delivery sleeve comprises an outer cannula channel (cannula 22 including lumen 26 of Baker) and at least one delivery channel (cannula 24 including lumen 27 of Baker), because the proposed modification entails placing the outer cannula (cannula 82 of Hibner) within the outer cannula channel (cannula 22 including lumen 26 of Baker);
(Claim 10) a distal end (col. 6, lines 60-61 “…distal ends of the cannulas…”) of the delivery sleeve (biopsy guide device 20 of Baker), when affixed to the tissue removal instrument, is in parallel alignment to the distal end of the outer cannula, because the proposed modification entails placing the outer cannula (cannula 82 of Hibner) within the outer cannula channel (cannula 22 including lumen 26 of Baker), which would inherently result in the longitudinal axis of the delivery sleeve (biopsy guide device 20 of Baker) and their respective distal ends to be parallel with the longitudinal axis of the inserted outer cannula (cannula 82 of Hibner);
(Claim 11) wherein when the delivery sleeve is in an uninstalled condition, the at least one delivery channel (cannula 24 including lumen 27 of Baker) is separated from the outer cannula channel along a length of the delivery sleeve (cannula 82 of Hibner), because each of the cannulas in Baker is described as a separate channel;
(Claim 14) wherein the delivery sleeve is removable from the outer cannula at the distal end of the outer cannula, because Baker describes the biopsy device as capable of being received (col. 6, lines 19-25);
(Claim 15) wherein the outer cannula is rotatable with respect to the delivery sleeve and the handpiece, because Hiber discloses at para. [0133] that the handpiece is capable of being used to independently rotate the needle aperture; and
(Claim 21) wherein when the delivery sleeve is in an installed condition, the outer cannula is disposed in the outer cannula channel and in communication with the at least one delivery channel along a length of the delivery sleeve, because the proposed modification entails placing the outer cannula (cannula 82 of Hibner) within the outer cannula channel (cannula 22 including lumen 26 of Baker), which would inherently yield one channel within another channel and also “in communication” with each other.
Regarding Claims 2, 3, 8, 17, 19 and 20, Hibner discloses a tissue removal system (Abstract “A biopsy device and method are provided for obtaining tissue samples.”), comprising inter alia:
a tissue removal instrument having a handpiece (handpiece 30) and an outer cannula (cannula 82), the outer cannula having an outer cannula lumen (upper cutter lumen 83), a proximal end (proximal most end of cannula 82 seen in FIG. 4), a distal end (closed via endpiece 90), and an outer cannula opening at the distal end (tissue receiving port 86), wherein the opening defines an edge for severing tissue (the defined perimeter of tissue receive port 86 is an edge that is capable of serving tissue, especially in tandem with cutter 100), and wherein the tissue removal instrument is configured to deliver vacuum to the outer cannula (para. [0085] “Lateral vacuum force 176 can be employed in combination with an axial vacuum force 180 through cutter lumen 104 to draw a tissue sample 182 into tissue port 86.”);
(Claims 19 and 20) wherein a level of the vacuum is variable and a user interface at the handpiece for controlling the level of vacuum (para. [0084] “Microprocessor 49 can be employed to activate valve 48 to supply vacuum force 176 when switch 64 is actuated by the user…”); and
(Claim 3) wherein the handpiece is a manipulative handle because it is handle shaped and capable of being manipulated.
Hibner discloses the claimed invention except for expressly disclosing (Claim 17) a delivery sleeve disposed about the outer cannula, wherein the delivery sleeve comprises an outer cannula channel and a delivery channel in fluid communication with the outer cannula channel along a length of the delivery sleeve such that, when the delivery sleeve is in an installed condition, outer cannula occupies the outer cannula channel and is in communication with the delivery channel along the length of the delivery sleeve, (Claim 2) wherein the delivery sleeve is removable from the outer cannula at the distal end of the outer cannula, (Claim 3) wherein the handpiece is a manipulative handle, (Claim 8) wherein the outer cannula is rotatable with respect to the delivery sleeve and the handpiece.
However, Baker teaches a biopsy guide device (biopsy guide device 20) that includes a plurality of channels (cannula 22 including lumen 26 and cannula 24 including lumen 27), where one channel is used to guide a biopsy device (cannula 22 including lumen 26, col. 6, lines 19-25) to a target area and where an additional channel (cannula 24 including lumen 27 of Baker, col. 6, lines 19-25). Additionally, in an alternative embodiment, there are two channels that are in fluid communication with one another along their length (FIG. 4E and col. 8, lines 29-32). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the outer cannula of Hibner the be disposed within the cannula 22 of the multiple channeled delivery sleeve of Baker, as Baker teaches at col. 4, lines 12-29 that the biopsy guide device (e.g., the claimed delivery sleeve) would have eliminated the need for expensive stereotactic equipment and further teaches at col. 4, lines 45-54 that the biopsy guide device (e.g., the claimed delivery sleeve) would have allowed confident positioning of the biopsy device within the target area.
The combination of Hibner and Baker (e.g., placing the claimed outer cannula of Hibner within cannula 22 of Baker) would have predictably yielded:
(Claim 17) a delivery sleeve (biopsy guide device 20 of Baker) disposed about the outer cannula (cannula 82 of Hibner), wherein the delivery sleeve comprises an outer cannula channel (cannula 22 including lumen 26 of Baker) and a delivery channel (cannula 24 including lumen 27 of Baker) in fluid communication with the outer cannula channel along a length of the delivery sleeve (FIG. 4E and col. 8, lines 29-32) such that, when the delivery sleeve is in an installed condition, the outer cannula occupies the outer cannula channel and is in communication with the delivery channel along the length of the delivery sleeve because in the alternative embodiment, there are two channels that are in fluid communication with one another along their length (FIG. 4E and col. 8, lines 29-32), which would place the outer cannula at least in “fluid communication” with the delivery channel (i.e., the fluid from the delivery channel would hit the outer cannula);
(Claim 2) wherein the delivery sleeve is removable from the outer cannula at the distal end of the outer cannula, because Baker describes the biopsy device as capable of being received (col. 6, lines 19-25);
(Claim 8) wherein the outer cannula is rotatable with respect to the delivery sleeve and the handpiece, because Hiber discloses at para. [0133] that the handpiece is capable of being used to independently rotate the needle aperture.
Regarding Claims 22, 23 and 25, Hibner discloses a tissue removal system (Abstract “A biopsy device and method are provided for obtaining tissue samples.”), comprising inter alia:
a handpiece (handpiece 30);
an outer cannula (cannula 82) having an outer cannula lumen (upper cutter lumen 83), a proximal end (proximal most end of cannula 82 seen in FIG. 4), a closed distal end (closed via endpiece 90), and an outer cannula opening proximate the closed distal end (tissue receiving port 86), wherein the opening defines an edge for severing tissue (the defined perimeter of tissue receive port 86 is an edge that is capable of serving tissue, especially in tandem with cutter 100).
Hibner discloses the claimed invention except for expressly disclosing (Claim 22) a delivery sleeve disposed about the outer cannula, wherein the delivery sleeve comprises an outer cannula channel and at least one delivery channel, wherein the outer cannula is rotatable with respect to the delivery sleeve and the handpiece, (Claim 23) wherein a distal end of the delivery sleeve, when affixed to the outer cannula, is in parallel alignment to the distal end of the outer cannula, and (Claim 25) wherein when the delivery sleeve is in an installed condition, the outer cannula is disposed in the outer cannula channel and in communication with the at least one delivery channel along a length of the delivery sleeve.
However, Baker teaches a biopsy guide device (biopsy guide device 20) that includes a plurality of channels (cannula 22 including lumen 26 and cannula 24 including lumen 27), where one channel is used to guide a biopsy device (cannula 22 including lumen 26, col. 6, lines 19-25) to a target area and where an additional channel (cannula 24 including lumen 27 of Baker, col. 6, lines 19-25). Additionally, in an alternative embodiment, there are two channels that are in fluid communication with one another along their length (FIG. 4E and col. 8, lines 29-32). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the outer cannula of Hibner the be disposed within the cannula 22 of the multiple channeled delivery sleeve of Baker, as Baker teaches at col. 4, lines 12-29 that the biopsy guide device (e.g., the claimed delivery sleeve) would have eliminated the need for expensive stereotactic equipment and further teaches at col. 4, lines 45-54 that the biopsy guide device (e.g., the claimed delivery sleeve) would have allowed confident positioning of the biopsy device within the target area.
The combination of Hibner and Baker (e.g., placing the claimed outer cannula of Hibner within cannula 22 of Baker) would have predictably yielded:
(Claim 22) a delivery sleeve (biopsy guide device 20 of Baker) disposed about the outer cannula (cannula 82 of Hibner), wherein the delivery sleeve comprises an outer cannula channel (cannula 22 including lumen 26 of Baker) and at least one delivery channel (cannula 24 including lumen 27 of Baker), because the proposed modification entails placing the outer cannula (cannula 82 of Hibner) within the outer cannula channel (cannula 22 including lumen 26 of Baker) and wherein the outer cannula is rotatable with respect to the delivery sleeve and the handpiece, because Hiber discloses at para. [0133] that the handpiece is capable of being used to independently rotate the needle aperture;
(Claim 23) wherein a distal end of the delivery sleeve, when affixed to the outer cannula, is in parallel alignment to the distal end of the outer cannula, because the proposed modification entails placing the outer cannula (cannula 82 of Hibner) within the outer cannula channel (cannula 22 including lumen 26 of Baker), which would inherently result in the longitudinal axis of the delivery sleeve (biopsy guide device 20 of Baker) and their respective distal ends to be parallel with the longitudinal axis of the inserted outer cannula (cannula 82 of Hibner); and
(Claim 25) wherein when the delivery sleeve is in an installed condition, the outer cannula is disposed in the outer cannula channel and in communication with the at least one delivery channel along a length of the delivery sleeve, because the proposed modification entails placing the outer cannula (cannula 82 of Hibner) within the outer cannula channel (cannula 22 including lumen 26 of Baker), which would inherently yield one channel within another channel and also “in communication” with each other.
Claim 16 and 24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hibner in view of Baker and further in view of US 20100152758 A1 to Mark et al. (hereinafter, Mark).
Hibner as modified does not expressly disclose an optical device positioned in the at least one delivery channel. However, Mark teaches a device for tissue cutting that includes a shaft with optical fibers (e.g., paragraph 0139 “Endoscope 300 is provided to visualize a target tissue 342 … with optical fibers …”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the delivery channel of Hibner as modified with the optical fibers of Mark, as Mark teaches at paragraph [0139] that the optical fibers would help visualize the target tissue in order to advance the device to the target tissue to take a biopsy sample.
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.
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791