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 .
Status of Claims
The Amendment filed 09/15/2022 has been entered.
Claims 7-10, 21-25, 30, and 32-36 are cancelled.
Claims 1-6, 11-20, 26-29, 31, and 37-43 remain pending in the application.
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.
(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.
Claims 1, 11, 14, 15, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Capozzi (U.S. Patent No. 5116315), hereinafter Capozzi.
Regarding claim 1, Capozzi discloses a sealant delivery system (system 10, see FIG. 1; the Examiner notes that all reference characters cited below refer to FIG. 1 unless otherwise stated), comprising:
a sealant applicator (holder 12) comprising:
two chambers (chambers of syringes 24 and 26) separate from one another, each chamber comprising at least one output port (the Examiner notes the syringes 24 and 26 have openings that connect to channels 50 and 52 of manifold 14) on a distal end thereof, and
a quarter turn connector (lock fittings 34 and 36) disposed on a distal end of the sealant applicator adjacent to the at least one output port of each chamber (see FIG. 1), the quarter turn connector shaped to releasably interlock with a corresponding quarter turn connector (lock fittings 38 and 40 of manifold 14; “Manifold 14 is configured to detachably lock to the syringes and bring the output streams thereof close together. Manifold 14 is in the form of a conical ellipsoid which has lock fittings 38 and 40 at its right end”; Col 4 Lines 41-44) of an injection needle assembly (needle assembly 18 and manifold 14) comprising a plurality of input ports (channels 50 and 52 of recesses 42 and 44) or with a corresponding quarter turn connector of a dual chamber mixing syringe comprising a plurality of mixing ports, wherein, when the injection needle assembly or the dual chamber mixing syringe is coupled to the sealant applicator via the quarter turn connector, the plurality of input ports or the plurality of mixing ports are aligned and sealed with the at least one output port of each chamber of the sealant applicator (see FIG. 1; “These lock fittings respectively have conical seal joints 42 and 44 thereon to receive the conical nose on their respective syringes and seal with respect thereto. Lock fittings 38 and 40, see FIG. 5, each have a pair of ears extending from the otherwise generally cylindrical exterior surface. Ears 46 and 48 are shown with respect to fitting 38. The nose of the syringe has exterior of its conical nose a cylindrical sleeve which extends over the ears 46 and 48 and has inclined flanges which engage under the ears 46 and 48 so that when inserted, a quarter turn locks the fitting together.”, Col 4 Lines 45-55).
Regarding claim 11, Capozzi discloses the claimed invention as discussed above concerning the rejection of claim 1, and Capozzi further discloses comprising: the injection needle assembly (needle assembly 18 and manifold 14), the injection needle assembly comprising: a hub (manifold 14) comprising the corresponding quarter turn connector (lock fittings 38 and 40) and the plurality of input ports (channels 50 and 52 of recesses 42 and 44) ; and an elongate hollow stylet (needle 74) that extends distally from the hub, the elongate hollow stylet having a proximal portion at the hub and a distal portion spaced apart from the proximal portion (see FIG. 1).
Regarding claim 14, Capozzi discloses the claimed invention as discussed above concerning the rejection of claim 1, and Capozzi further discloses comprising: the dual chamber mixing syringe (needle assembly 18 and manifold 14), the dual chamber mixing syringe comprising: a first mixing chamber having a first mixing port of the plurality of mixing ports (channel 50 and recess 42), and a second mixing chamber having a second mixing port of the plurality of mixing ports (channel 52 and recess 40).
Regarding claim 15, Capozzi discloses the claimed invention as discussed above concerning the rejection of claim 14, and Capozzi further discloses wherein the first mixing port of the plurality of mixing ports of the dual chamber mixing syringe is sealed and aligned with a first output port corresponding to a first chamber of the two chambers of the sealant applicator (see FIG. 1) and the second mixing port of the plurality of mixing ports of the dual chamber mixing syringe is sealed and aligned with a second output port corresponding to a second chamber of the two chambers of the sealant applicator (see FIG. 1) when the quarter turn connector of the sealant applicator is interlocked with the corresponding quarter turn connector of the dual chamber mixing syringe (“These lock fittings respectively have conical seal joints 42 and 44 thereon to receive the conical nose on their respective syringes and seal with respect thereto. Lock fittings 38 and 40, see FIG. 5, each have a pair of ears extending from the otherwise generally cylindrical exterior surface. Ears 46 and 48 are shown with respect to fitting 38. The nose of the syringe has exterior of its conical nose a cylindrical sleeve which extends over the ears 46 and 48 and has inclined flanges which engage under the ears 46 and 48 so that when inserted, a quarter turn locks the fitting together.”, Col 4 Lines 45-55).
Regarding claim 26, Capozzi discloses a sealant applicator (holder 12, see FIG. 1; the Examiner notes that all reference characters cited below refer to FIG. 1 unless otherwise stated), comprising:
two chambers (chambers of syringes 24 and 26) separate from one another, each chamber comprising at least one output port (the Examiner notes the syringes 24 and 26 have openings that connect to channels 50 and 52 of manifold 14) on a distal end thereof, and
a keyed connector (lock fittings 34 and 36) disposed on a distal end of the sealant applicator adjacent to the at least one output port of each chamber (see FIG. 1), the keyed connector shaped to releasably interlock with a corresponding keyed connector (manifold 14; “Manifold 14 is configured to detachably lock to the syringes and bring the output streams thereof close together. Manifold 14 is in the form of a conical ellipsoid which has lock fittings 38 and 40 at its right end”; Col 4 Lines 41-44) of an injection needle assembly (needle assembly 18) comprising a plurality of input ports (channels 50 and 52) or a corresponding keyed connector of a dual chamber mixing syringe comprising a plurality of mixing ports, wherein, when the injection needle assembly or the dual chamber mixing syringe is coupled to the sealant applicator via the keyed connector, the plurality of input ports or the plurality of mixing ports are aligned and sealed with the at least one output port of each chamber of the sealant applicator (see FIG. 1; “These lock fittings respectively have conical seal joints 42 and 44 thereon to receive the conical nose on their respective syringes and seal with respect thereto. Lock fittings 38 and 40, see FIG. 5, each have a pair of ears extending from the otherwise generally cylindrical exterior surface. Ears 46 and 48 are shown with respect to fitting 38. The nose of the syringe has exterior of its conical nose a cylindrical sleeve which extends over the ears 46 and 48 and has inclined flanges which engage under the ears 46 and 48 so that when inserted, a quarter turn locks the fitting together.”, Col 4 Lines 45-55).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 12, 13, 16, 31, 42, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Capozzi (U.S. Patent No. 5116315), hereinafter Capozzi, further in view of Ilan et al. (U.S. Patent No. 20100217231), hereinafter Ilan.
Regarding claim 12, Capozzi discloses the claimed invention as discussed above concerning the rejection of claim 11, and Capozzi further discloses wherein the elongate hollow stylet (needle 74) comprises: an outer side wall (outer wall of needle 74) extending from the proximal portion to the distal portion and defining an outer lumen that is fluidly coupled (see needle outflow in Col 5 Lines 11-21) to at least a first one of the plurality of input ports. However, Capozzi does not expressly state an inner side wall extending from the proximal portion to the distal portion and defining an inner lumen disposed within the outer lumen such that the inner lumen is concentric with the outer lumen and has a cross-sectional size that is smaller than the outer lumen, the inner lumen being fluidly coupled to at least a second one of the plurality of input ports; and a mixing chamber disposed at the distal portion of the elongate hollow stylet, the mixing chamber fluidly coupled to the outer lumen and the inner lumen and comprising at least one side port.
Ilan teaches a device for administering an at least two-component substance (Abstract) comprising an inner side wall (inner cannula 14) extending from the proximal portion to the distal portion and defining an inner lumen (inner lumen 16) disposed within the outer lumen such that the inner lumen is concentric with the outer lumen (outer lumen 28) and has a cross-sectional size that is smaller than the outer lumen (see FIG. 13), the inner lumen being fluidly coupled to at least a second one of the plurality of input ports, and a mixing chamber (see chamber of supplemental part 90 in FIG. 13) disposed at the distal portion of the elongate hollow stylet, the mixing chamber fluidly coupled (see [0070]) to the outer lumen and the inner lumen and comprising at least one side port (hole 66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Capozzi to include an inner side wall extending from the proximal portion to the distal portion and defining an inner lumen disposed within the outer lumen such that the inner lumen is concentric with the outer lumen and has a cross-sectional size that is smaller than the outer lumen, the inner lumen being fluidly coupled to at least a second one of the plurality of input ports, and a mixing chamber disposed at the distal portion of the elongate hollow stylet, the mixing chamber fluidly coupled to the outer lumen and the inner lumen and comprising at least one side port. Doing so allows the components flow separately through the inner and outer lumen and mix in the inner cannula immediately prior to being applied into the selected target tissue or region, as taught by Ilan (see [0070]).
Regarding claim 13, Capozzi in view of Ilan teaches the claimed invention as discussed above concerning the rejection of claim 12, and Capozzi further discloses wherein the first one of the plurality of input ports of the elongate hollow stylet is sealed and aligned with a first output port corresponding to a first chamber of the two chambers of the sealant applicator and the second one of the plurality of input ports of the elongate hollow stylet is sealed and aligned with a second output port corresponding to a second chamber of the two chambers of the sealant applicator when the quarter turn connector of the sealant applicator is interlocked with the corresponding quarter turn connector of the elongate hollow stylet (see FIG. 1; “These lock fittings respectively have conical seal joints 42 and 44 thereon to receive the conical nose on their respective syringes and seal with respect thereto. Lock fittings 38 and 40, see FIG. 5, each have a pair of ears extending from the otherwise generally cylindrical exterior surface. Ears 46 and 48 are shown with respect to fitting 38. The nose of the syringe has exterior of its conical nose a cylindrical sleeve which extends over the ears 46 and 48 and has inclined flanges which engage under the ears 46 and 48 so that when inserted, a quarter turn locks the fitting together.”, Col 4 Lines 45-55)
Regarding claim 16, Capozzi discloses a sealant delivery system (system 10, see FIG. 1; the Examiner notes that all reference characters cited below refer to FIG. 1 unless otherwise stated), comprising:
a sealant applicator (holder 12) comprising two chambers separate from one another (chambers of syringes 24 and 26), each chamber comprising at least one output port on a distal end thereof (the Examiner notes the syringes 24 and 26 have openings that connect to channels 50 and 52 of manifold 14);
a keyed connector (lock fittings 34 and 36) disposed on a distal end of the sealant applicator adjacent to the at least one output port of each chamber (see FIG. 1); and
an injection needle assembly (needle assembly 18 and manifold 14) comprising:
a hub (manifold 14) having a hub keyed connector (lock fittings 38 and 40) that releasably interlocks with the keyed connector disposed on the distal end of the sealant applicator (“Manifold 14 is configured to detachably lock to the syringes and bring the output streams thereof close together. Manifold 14 is in the form of a conical ellipsoid which has lock fittings 38 and 40 at its right end”; Col 4 Lines 41-44),
a plurality of input ports (channels 50 and 52), and
an elongate hollow stylet (needle 74) that extends distally from the hub, the elongate hollow stylet having a proximal portion at the hub and a distal portion spaced apart from the proximal portion (see FIG. 1), the elongate hollow stylet comprising an outer side wall (outer wall of needle 74) extending from the proximal portion to the distal portion and defining an outer lumen that is fluidly coupled (see needle outflow in Col 5 Lines 11-21) to at least a first one of the plurality of input ports,
wherein, when the hub keyed connector that interlocks with the keyed connector disposed on the distal end of the sealant applicator, the plurality of input ports are each aligned and sealed with one of the at least one output port of each chamber (see FIG. 1; “These lock fittings respectively have conical seal joints 42 and 44 thereon to receive the conical nose on their respective syringes and seal with respect thereto. Lock fittings 38 and 40, see FIG. 5, each have a pair of ears extending from the otherwise generally cylindrical exterior surface. Ears 46 and 48 are shown with respect to fitting 38. The nose of the syringe has exterior of its conical nose a cylindrical sleeve which extends over the ears 46 and 48 and has inclined flanges which engage under the ears 46 and 48 so that when inserted, a quarter turn locks the fitting together.”, Col 4 Lines 45-55). However, Capozzi does not expressly state an inner side wall extending from the proximal portion to the distal portion and defining an inner lumen disposed within the outer lumen such that the inner lumen is concentric with the outer lumen and has a cross-sectional size that is smaller than the outer lumen, the inner lumen being fluidly coupled to at least a second one of the plurality of input ports, and a mixing chamber disposed at the distal portion of the elongate hollow stylet, the mixing chamber fluidly coupled to the outer lumen and the inner lumen and comprising at least one side port.
Ilan teaches a device for administering an at least two-component substance (Abstract) comprising an inner side wall (inner cannula 14) extending from the proximal portion to the distal portion and defining an inner lumen (inner lumen 16) disposed within the outer lumen such that the inner lumen is concentric with the outer lumen (outer lumen 28) and has a cross-sectional size that is smaller than the outer lumen (see FIG. 13), the inner lumen being fluidly coupled to at least a second one of the plurality of input ports, and a mixing chamber (see chamber of supplemental part 90 in FIG. 13) disposed at the distal portion of the elongate hollow stylet, the mixing chamber fluidly coupled (see [0070]) to the outer lumen and the inner lumen and comprising at least one side port (hole 66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Capozzi to include an inner side wall extending from the proximal portion to the distal portion and defining an inner lumen disposed within the outer lumen such that the inner lumen is concentric with the outer lumen and has a cross-sectional size that is smaller than the outer lumen, the inner lumen being fluidly coupled to at least a second one of the plurality of input ports, and a mixing chamber disposed at the distal portion of the elongate hollow stylet, the mixing chamber fluidly coupled to the outer lumen and the inner lumen and comprising at least one side port. Doing so allows the components flow separately through the inner and outer lumen and mix in the inner cannula immediately prior to being applied into the selected target tissue or region, as taught by Ilan (see [0070]).
Regarding claim 31, Capozzi discloses an injection needle assembly (needle assembly 18 and manifold 14, see FIG. 1; the Examiner notes that all reference characters cited below refer to FIG. 1 unless otherwise stated), comprising:
a hub (manifold 14) having a hub keyed connector (lock fittings 38 and 40) that releasably interlocks with a corresponding keyed connector (“Manifold 14 is configured to detachably lock to the syringes and bring the output streams thereof close together. Manifold 14 is in the form of a conical ellipsoid which has lock fittings 38 and 40 at its right end”; Col 4 Lines 41-44) disposed on a sealant applicator (holder 12);
a plurality of input ports disposed within the hub (channels 50 and 52); and
an elongate hollow stylet (needle 74) that extends distally from the hub, the elongate hollow stylet having a proximal portion at the hub and a distal portion spaced apart from the proximal portion (See FIG. 1), the elongate hollow stylet comprising:
an outer side wall (outer wall of needle 74) extending from the proximal portion to the distal portion and defining an outer lumen that is fluidly coupled (see needle outflow in Col 5 Lines 11-21) to at least a first one of the plurality of input ports,
wherein, when the hub keyed connector that interlocks with the keyed connector disposed on the distal end of the sealant applicator, the plurality of input ports are each aligned and sealed with a corresponding output port of the sealant applicator (see FIG. 1; “These lock fittings respectively have conical seal joints 42 and 44 thereon to receive the conical nose on their respective syringes and seal with respect thereto. Lock fittings 38 and 40, see FIG. 5, each have a pair of ears extending from the otherwise generally cylindrical exterior surface. Ears 46 and 48 are shown with respect to fitting 38. The nose of the syringe has exterior of its conical nose a cylindrical sleeve which extends over the ears 46 and 48 and has inclined flanges which engage under the ears 46 and 48 so that when inserted, a quarter turn locks the fitting together.”, Col 4 Lines 45-55). However, Capozzi does not expressly state an inner side wall extending from the proximal portion to the distal portion and defining an inner lumen disposed within the outer lumen such that the inner lumen is concentric with the outer lumen and has a cross-sectional size that is smaller than the outer lumen, the inner lumen being fluidly coupled to at least a second one of the plurality of input ports, and a mixing chamber disposed at the distal portion of the elongate hollow stylet, the mixing chamber fluidly coupled to the outer lumen and the inner lumen and comprising at least one side port.
Ilan teaches a device for administering an at least two-component substance (Abstract) comprising an inner side wall (inner cannula 14) extending from the proximal portion to the distal portion and defining an inner lumen (inner lumen 16) disposed within the outer lumen such that the inner lumen is concentric with the outer lumen (outer lumen 28) and has a cross-sectional size that is smaller than the outer lumen (see FIG. 13), the inner lumen being fluidly coupled to at least a second one of the plurality of input ports, and a mixing chamber (see chamber of supplemental part 90 in FIG. 13) disposed at the distal portion of the elongate hollow stylet, the mixing chamber fluidly coupled (see [0070]) to the outer lumen and the inner lumen and comprising at least one side port (hole 66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Capozzi to include inner side wall extending from the proximal portion to the distal portion and defining an inner lumen disposed within the outer lumen such that the inner lumen is concentric with the outer lumen and has a cross-sectional size that is smaller than the outer lumen, the inner lumen being fluidly coupled to at least a second one of the plurality of input ports, and a mixing chamber disposed at the distal portion of the elongate hollow stylet, the mixing chamber fluidly coupled to the outer lumen and the inner lumen and comprising at least one side port. Doing so allows the components flow separately through the inner and outer lumen and mix in the inner cannula immediately prior to being applied into the selected target tissue or region, as taught by Ilan (see [0070]).
Regarding claim 42, Capozzi in view of Ilan teaches the claimed invention as discussed above concerning the rejection of claim 31, and Capozzi further discloses wherein the inner lumen is fluidly coupled to the second one of the plurality of input ports via an angled flow channel through a body of the hub (the Examiner notes FIG. 2 having angled orientation of channels 50 and 52 in manifold 14. The Examiner is of the position this is sufficient disclosure for a fluidic coupling between lumen and port via angled flow channel through the hub).
Regarding claim 43, Capozzi in view of Ilan teaches the claimed invention as discussed above concerning the rejection of claim 31, and Ilan further discloses wherein the inner lumen (inner lumen 16) is fluidly coupled to the second one of the plurality of input ports (port 24) via a flow channel that extends laterally through a body of the hub (see FIG. 2).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Capozzi (U.S. Patent No. 5116315), hereinafter Capozzi, further in view of Ilan et al. (U.S. Patent Pub. 20100217231), hereinafter Ilan, further in view of Linder et al. (U.S. Patent No. 5665067), hereinafter Linder.
Regarding claim 27, Capozzi discloses the claimed invention as discussed above concerning the rejection of claim 26, and Capozzi further discloses wherein the keyed connector(lock fittings 34 and 36) comprises: a circular protrusion extending distally from the distal end of the sealant applicator (holder 12), the circular protrusion comprising the at least one output port of each of the two chambers (chambers of syringes 24 and 26; see FIG. 1). However, Capozzi does not expressly state a semi-circular channel disposed within the distal end of the sealant applicator along a periphery of the circular protrusion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Capozzi to include a semi-circular channel disposed within the distal end of the sealant applicator along a periphery of the circular protrusion (see FIG. 3A). Doing so provides more than one exit opening during delivery, as taught by Linder (see Col 5 Lines 5-26).
Claims 37-41 are rejected under 35 U.S.C. 103 as being unpatentable over Capozzi (U.S. Patent No. 5116315), hereinafter Capozzi, further in view of Ilan et al. (U.S. Patent Pub. 20100217231), hereinafter Ilan, further in view of Balbierz et al. (U.S. Patent No. 6770070), hereinafter Balbierz.
Regarding claim 37, Capozzi in view of Ilan teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan does not expressly state wherein the at least one side port in the mixing chamber at the distal portion of the elongate hollow stylet comprises at least three side ports in the distal portion arranged around a perimeter of the elongate hollow stylet.
Balbierz teaches a ling biopsy apparatus (Abstract) wherein the at least one side port in the mixing chamber at the distal portion of the elongate hollow stylet comprises at least three side ports (apertures 23) in the distal portion arranged around a perimeter of the elongate hollow stylet (see FIG. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Capozzi in view of Ilan to have the at least one side port in the mixing chamber at the distal portion of the elongate hollow stylet comprise at least three side ports in the distal portion arranged around a perimeter of the elongate hollow stylet. Doing so provides a variety in fluid infusion types based on the fluid, as taught by Balbierz (see Col 15 Lines 12-34).
Regarding claim 38, Capozzi in view of Ilan teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan does not expressly state wherein the at least one side port in the mixing chamber at the distal portion of the elongate hollow stylet includes at least two longitudinally spaced side ports.
Balbierz teaches a ling biopsy apparatus (Abstract) wherein the at least one side port in the mixing chamber at the distal portion of the elongate hollow stylet includes at least two longitudinally spaced side ports (apertures 23; see FIG. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Capozzi in view of Ilan to have the at least one side port in the mixing chamber at the distal portion of the elongate hollow stylet include at least two longitudinally spaced side ports. Doing so provides a variety in fluid infusion types based on the fluid, as taught by Balbierz (see Col 15 Lines 12-34).
Regarding claim 39, Capozzi in view of Ilan teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan does not expressly state wherein the distal end of the elongate hollow stylet is a closed distal end.
Balbierz teaches a ling biopsy apparatus (Abstract) wherein the distal end of the elongate hollow stylet is a closed distal end (see FIG. 5k).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Capozzi in view of Ilan to have the distal end of the elongate hollow stylet be a closed distal end. Doing so provides a shaped needle tip for producing a minimal profile, allowing the elastic pleural tissue in target tissue site to rapidly contract around and close the void space preventing or otherwise reducing the risk of pneumothorax as taught by Balbierz (see Col 12 Lines 23-26).
Regarding claim 40, Capozzi in view of Ilan teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan does not expressly state wherein the distal end of the elongate hollow stylet is a closed needle tip that terminates a distal extent of the inner lumen and the outer lumen.
Balbierz teaches a ling biopsy apparatus (Abstract) the distal end of the elongate hollow stylet is a closed needle tip that terminates a distal extent of the inner lumen and the outer lumen (see FIG. 5k).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Capozzi in view of Ilan to have the distal end of the elongate hollow stylet be a closed needle tip that terminates a distal extent of the inner lumen and the outer lumen. . Doing so provides a shaped needle tip for producing a minimal profile, allowing the elastic pleural tissue in target tissue site to rapidly contract around and close the void space preventing or otherwise reducing the risk of pneumothorax as taught by Balbierz (see Col 12 Lines 23-26).
Regarding claim 41, Capozzi in view of Ilan teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan does not expressly state wherein the elongate hollow stylet further comprises an elongate cannula that defines the outer side wall and the outer lumen; and a stylet needle tip defined by the distal portion, wherein the stylet needle tip is attached to the elongate cannula to distally close the outer lumen of the elongate cannula.
Balbierz teaches a ling biopsy apparatus (Abstract) wherein the elongate hollow stylet (needle 16) further comprises an elongate cannula that defines the outer side wall and the outer lumen (see FIG. 5C) ; and a stylet needle tip (tip 16’) defined by the distal portion, wherein the stylet needle tip is attached to the elongate cannula to distally close the outer lumen of the elongate cannula (see FIG. 5K).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Capozzi in view of Ilan to comprises an elongate cannula that defines the outer side wall and the outer lumen; and a stylet needle tip defined by the distal portion, wherein the stylet needle tip is attached to the elongate cannula to distally close the outer lumen of the elongate cannula. Doing so provides a variety in fluid infusion types based on the fluid, as taught by Balbierz (see Col 15 Lines 12-34).
Allowable Subject Matter
Claims 2-6, 17-20, 28, and 29 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
03/03/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783