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 were previously cancelled.
Claims 2, 17, and 28 are cancelled.
Claims 1, 3-6, 11-16, 18-20, 26, 27, 29, 31, and 37-43 remain pending in the application.
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 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. Publication No. 20100217231), hereinafter Ilan, further in view of Goodman et al. (U.S. Patent No. 10231720), hereinafter Goodman.
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]).
However, Capozzi in view of Ilan does not expressly state the hub keyed connector having a recess and a plurality of input ports disposed within the hub at the recess of the hub keyed connector.
Goodman teaches modular apparatuses for delivery of multi-part fluid materials (Abstract) including a hub keyed connector (housing 160) having a recess (see hollow shape in Col 5 Lines 14-16) and a plurality of input ports (cannulas 140 and 150 see FIGS. 3-4) disposed within the hub (applicator component 100) at the recess of the hub keyed connector.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Capozzi in view of Ilan to comprise the hub keyed connector having a recess and a plurality of input ports disposed within the hub at the recess of the hub keyed connector. Doing so provides ergonomic support for the user, as taught by Goodman (see Col 5 Lines 14-16).
Regarding claim 42, Capozzi in view of Ilan in view of Goodman 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 in view of Goodman 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).
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 Goodman et al. (U.S. Patent No. 10231720), hereinafter Goodman, further in view of Balbierz et al. (U.S. Patent No. 6770070), hereinafter Balbierz.
Regarding claim 37, Capozzi in view of Ilan in view of Goodman teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan in view of Goodman 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 in view of Goodman 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 in view of Goodman teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan in view of Goodman 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 in view of Goodman 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 in view of Goodman teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan in view of Goodman 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 in view of Goodman 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 in view of Goodman teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan in view of Goodman 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 in view of Goodman 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 in view of Goodman teaches the claimed invention as discussed above concerning the rejection of claim 31, however, Capozzi in view of Ilan in view of Goodman 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 in view of Goodman 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).
Response to Arguments
Applicant’s arguments, see Remarks filed 06/17/2026, with respect to the rejection(s) of claim(s) 1-6, 11-20, 26-29, 31, and 37-43 under 35 U.S.C. 103 over Capozzi (U.S. Patent No. 5116315) further in view of Ilan (U.S. Publication No. 20100217231) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Capozzi, further in view of Ilan, further in view of Goodman et al. (U.S. Patent No. 10231720).
Allowable Subject Matter
Claims 1, 3-6, 11-16, 18-20, 26, 27, and 29 are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
07/11/2026 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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