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 .
Response to Arguments
Applicant’s arguments, filed 30 March 2026 with regards to the 35 USC 103 rejections are not persuasive. Applicant argues that the incorporation of the tip necessarily requires ultrasonic vibration. Examiner respectfully disagrees. In response to applicant's argument that the modification requires the addition of ultrasonic vibration, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Thompson teaches the irregular face of the improved needle is not so easily occluded (col 3, lines 10-20). While Thompson indeed applies vibrations to the needle, this type of needle structure would still prevent occlusion regardless of the vibration since the needle structure still allows for material to roll off the tip and not stay due to the concave shape.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Thompson recognizes the needle does not easily occlude and states that the tip is designed to prevent total occlusion (col 3, lines 10-20, and col 7, lines 45-55). It would be obvious to a person of ordinary skill in the art at the effective filling date to modify Smith with the needle of Thompson in order to utilize a needle reduce occlusion.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-12 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 9, 13, 17-25, 27-28, and 30-31 of copending Application No. 17/314004. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are more specific than the copending application.
Instant App
Co-pending App 17/314004
(Original) A rapid deployment chest port, comprising: a frame comprising a lumen; a plunger at least partially within a lumen of the frame, the plunger comprising a stylet shaft traversing the interior of the lumen of the frame, a needle operably connected to the distal end of the frame, the distal tip of the needle comprising a concave curvature, and a plunger port at the proximal end of the plunger; and a balloon attached to the outer diameter of the frame, the balloon configured to expand in the interior of the chest cavity of the patient; an external valve port attached to the outer diameter of the frame and fluidly connected to the balloon; and an insertion stabilization platform slidable along the outer diameter of the frame and proximal to the balloon.
7. (Currently Amended) The rapid deployment chest port of claim1, wherein the insertion stabilization platform is no more than 7 cm away from the needle when the rapid deployment chest port is inserted into the chest cavity of the patient.
1. (Previously Presented) A rapid deployment chest port, comprising:a frame comprising a lumen and a plunger port; a removable plunger comprising a blade at the distal end, wherein the removable plunger is within the lumen of the frame; and a stabilizing component configured to stabilize the frame inside and outside a chest cavity of a patient, the stabilizing component comprising: an inflatable [[a]] balloon attached to an outer diameter of the frameand configured to be expanded within the chest cavity of the patient; and an insertion stabilization platform attached to and slidable along the outer diameter of the frame proximal to the balloons, wherein the insertion stabilization platform is no more than 7 cm away from the blade when the rapid deployment chest port is inserted into the chest cavity of the patient.
2. (Original) The rapid deployment chest port of claim 1 wherein the distal tip of the needle comprises multiple concave curvatures.
1. (Previously Presented) A rapid deployment chest port, comprising:a frame comprising a lumen and a plunger port; a removable plunger comprising a blade at the distal end, wherein the removable plunger is within the lumen of the frame; and a stabilizing component configured to stabilize the frame inside and outside a chest cavity of a patient, the stabilizing component comprising: an inflatable [[a]] balloon attached to an outer diameter of the frameand configured to be expanded within the chest cavity of the patient; and an insertion stabilization platform attached to and slidable along the outer diameter of the frame proximal to the balloons, wherein the insertion stabilization platform is no more than 7 cm away from the blade when the rapid deployment chest port is inserted into the chest cavity of the patient.
22. (Previously Presented) The rapid deployment chest port of claim 1, wherein the blade has a cone shape.
3. (Currently Amended) The rapid deployment chest port of claim 1, wherein the insertion stabilization platform operably connected to a pinch locking stabilizer configured to reversibly immobilize the insertion stabilization platform.
13. (Previously Presented) The rapid deployment chest port of claim 1, wherein the insertion stabilization platform further comprises a fixation flexure operable to allow sliding of the insertion stabilization platform along the outer diameter of the frame and then secure the insertion stabilization platform to the frame.
4. (Currently Amended) A rapid deployment chest port of claim1, wherein,the insertion stabilization platform is operably connected to a pinch locking stabilizer configured to reversibly immobilize the insertion stabilization platform.
13. (Previously Presented) The rapid deployment chest port of claim 1, wherein the insertion stabilization platform further comprises a fixation flexure operable to allow sliding of the insertion stabilization platform along the outer diameter of the frame and then secure the insertion stabilization platform to the frame.
5. (Currently Amended) The rapid deployment chest port of claim1
3. (Previously Presented) The rapid deployment chest port of claim 1, further comprising an external valve port attached to the outer diameter of the frame the external valve port operable to permit a check valve to be removably inserted into the frame.
6. (Currently Amended) The rapid deployment chest port of claim1, , , , wherein the insertion stabilization platform further comprises a fixation flexure operable to allow movement of and then secure the insertion stabilization platform to the frame.
13. (Previously Presented) The rapid deployment chest port of claim 1, wherein the insertion stabilization platform further comprises a fixation flexure operable to allow sliding of the insertion stabilization platform along the outer diameter of the frame and then secure the insertion stabilization platform to the frame.
7. (Currently Amended) The rapid deployment chest port of claim1, wherein the insertion stabilization platform is no more than 7 cm away from the needle when the rapid deployment chest port is inserted into the chest cavity of the patient.
1. (Previously Presented) A rapid deployment chest port, comprising:a frame comprising a lumen and a plunger port; a removable plunger comprising a blade at the distal end, wherein the removable plunger is within the lumen of the frame; and a stabilizing component configured to stabilize the frame inside and outside a chest cavity of a patient, the stabilizing component comprising: an inflatable [[a]] balloon attached to an outer diameter of the frameand configured to be expanded within the chest cavity of the patient; and an insertion stabilization platform attached to and slidable along the outer diameter of the frame proximal to the balloons, wherein the insertion stabilization platform is no more than 7 cm away from the blade when the rapid deployment chest port is inserted into the chest cavity of the patient.
22. (Previously Presented) The rapid deployment chest port of claim 1, wherein the blade has a cone shape.
8. (Currently Amended) The rapid deployment chest port of claim1, comprising a handle with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame.
17. (Previously Presented) The rapid deployment chest port of claim 1, further comprising a handle with a connector operable to removably attach the handle to the plunger port at a proximal end of the frame.
9. (Original) The rapid deployment chest port of claim 8, wherein the handle further comprises a syringe port operable to receive an aspiration syringe.
18. (Original) The rapid deployment chest port of claim 17, wherein the handle further comprises a syringe port operable to receive an aspiration syringe.
10. (Currently Amended) The rapid deployment chest port of claim1, wherein the plunger port is a 1- way valve.
19. (Previously Presented) The rapid deployment chest port of claim 17, wherein the plunger port is a 1-way valve.
11. (Currently Amended) The rapid deployment chest port of claim1, wherein the external valve port is a 1-way valve operable to receive a syringe to expand the balloon.
20. (Previously Presented) The rapid deployment chest port of claim 4, wherein the external valve port is a 1-way valve operable to receive a syringe to expand the balloon.
12. (Currently Amended) The rapid deployment chest port of claim1, wherein a ratio of the diameter of the balloon to the diameter of the frame is 2.5 to 6.
21. (Previously Presented) The rapid deployment chest port of claim 1, wherein a ratio of a diameter of the balloon to a diameter of the frame is 2.5 to 6.
20. (Currently Amended) A method of removing air or fluid contained within a pleural space of a mammalian patient, the method comprising:inserting the needle of the device of claim1
25. (Previously Presented) A method of removing air or fluid or both contained within a pleural space of a mammalian patient, the method comprising:inserting the blade of the removable plunger and a distal portion of the frame of the rapid deployment chest port of claim 1 into a chest cavity of a patient; expanding the balloon on the inside of the chest cavity of the patient; and removing the plunger from the plunger port.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
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.
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 1-14, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2021/0338994 with an effective filling date of 11/30/2018) in view of Thompson (US 4689040).
Regarding claim 1, Smith discloses a rapid deployment chest port (figure 6), comprising: a frame (104) comprising a lumen (interior lumen of 104); a plunger (122, [0055]) at least partially within a lumen of the frame (figure 6), the plunger comprising a stylet shaft ([0058]) traversing the interior of the lumen of the frame, a needle (102, figure 6) operably connected to the distal end of the frame (figure 6), and a plunger port (622) at the proximal end of the plunger; and a balloon (106, [0058]) attached to the outer diameter of the frame (figure 6), the balloon configured to expand in the interior of the chest cavity of the patient ([0040]); an external valve port (610, figure 6) attached to the outer diameter of the frame and fluidly connected to the balloon ([0055]); and an insertion stabilization platform slidable (606, [0056]) along the outer diameter of the frame and proximal to the balloon (figure 6).
Smith does not disclose the distal tip of the needle comprising a concave curvature.
Thompson discloses a device relatively pertinent to the Applicant’s problem of providing access to the body using needles and teaches a needle wherein the distal tip of the needle comprises a concave curvature (figures 3-5, col 2, lines 58-65).
Thompson provides a concave needle in order to reduce material occlusion (col 3, lines 10-20). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Smith with the needle of Thompson in order to utilize a needle reduce occlusion.
Regarding claim 2, Thompson teaches wherein the distal tip of the needle comprises multiple concave curvatures (sides of the tip have at least two concave curvatures, figures 3-5).
Thompson provides a concave needle in order to reduce material occlusion (col 3, lines 10-20). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Smith with the needle of Thompson in order to utilize a needle reduce occlusion.
Regarding claims 3-4, Smith discloses wherein the insertion stabilization platform operably connected to a pinch locking stabilizer configured to reversibly immobilize the insertion stabilization platform ([0067]).
Regarding claim 5, Smith discloses the chest port further comprising: an external check valve assembly operable to connect to the plunger port after removal of the plunger, the external check valve assembly comprising one or more of: a connector configured to connect to the port, valve outlet tubing operably associated with the connector, a check valve operably associated with the valve outlet tubing, and valve inlet tubing operably connected to the check valve and proximal to the check valve (a reciprocal luer connector 708 may connect to the plunger port 622 to attach an external check valve assembly to the frame 104. The external check valve assembly may operate to allow a check valve to be inserted into frame 104 without the check valve needing to be integrated into rapid deployment chest port 700. In some variations, the check valve assembly may include the luer connector 708, a check valve 712, valve outlet tubing 710 connected to the luer connector and distal to the check valve, valve inlet tubing 714 proximal to the check valve, and a connector 716 to a suction source, [0061]).
Regarding claim 6, Smith discloses wherein the insertion stabilization platform further comprises a fixation flexure operable to allow movement of and then secure the insertion stabilization platform to the frame ([0067]).
Regarding claim 7, Smith discloses wherein the insertion stabilization platform is no more than 7 cm away from the needle when the rapid deployment chest port is inserted into the chest cavity of the patient ([0065]).
Regarding claim 8, Smith discloses a handle (702) with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame ([0058]).
Regarding claim 9, Smith discloses wherein the handle further comprises a syringe port (720) operable to receive an aspiration syringe (722).
Regarding claim 10, Smith discloses wherein the plunger port is a 1- way valve ([0051]).
Regarding claim 11, Smith discloses wherein the external valve port is a 1-way valve operable to receive a syringe to expand the balloon ([0062]).
Regarding claim 12, Smith discloses wherein a ratio of the diameter of the balloon to the diameter of the frame is 2.5 to 6 ([.070]).
Regarding claim 13, Smith discloses wherein the chest port is coated with a coating ([0048]) which necessitates the balloon as well.
Regarding claim 14, Smith discloses wherein the balloon comprises silicone ([0068]).
Regarding claims 16-19, Smith does not disclose the wherein the balloon thickness is from 0.005" - 0.060" (claim 16), wherein the balloon thickness is from 0.020" - 0.040" (Claim 17), wherein the coating thickness is from 0.5 - 10 microns (claim 18), wherein the coating thickness is from 1.5 - 3.5 microns (claim 19).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Smith to have a desired thickness and coating thickness since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Smith would not operate differently with the claimed thicknesses and since the balloon of Smith is used to be inserted and operates with the same function, thus the device would function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “can” be within the claimed ranges (specification pp. [0075]).
Regarding claim 20, Smith discloses a method of removing air or fluid contained within a pleural space of a mammalian patient, the method comprising: inserting the needle of the device of claim 1 (see rejection of claim 1) into the patient's chest cavity ([0065]); expanding the balloon in the inside of the patient's chest cavity ([0009]); and removing the plunger from the plunger port ([0009]).
Claims 15 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (in view of Thompson further in view of McKinney (US 2021/0038099).
Regarding claim 15, Smith and Thompson does not disclose wherein the coating comprises paralene. The limitation “paralene” is interpreted as –parylene—as the specification describes this material as poly(p-xylylene) polymers which is parylene.
McKinney discloses a catheter with a balloon and teaches wherein the coating comprises parylene ([0251]) is applied to balloon (456).
McKinney provides a coating to achieve a desired modulus of balloon ([0251]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Smith with the material coating of Mckinney to achieve a desirable modulus of balloon.
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 KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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