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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 19, 2026 has been entered.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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 1-6, 8-18, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwards et al. (US 8,221,452 B2).
Regarding claim 1, Edwards discloses a laparoscopic applicator (Figs. 4A-4F) for dispensing a paste comprising a haemostatic agent for stopping a bleeding (Col. 4 lines 17-33), at a selected site by means of an external surgical robotic arm (i.e., the device is capable of being used by an external surgical robotic arm; note also that the surgical robotic arm is not positively recited and only recited in the preamble), and for being inserted into a trocar port (i.e., the device of Edwards is fully capable of being inserted into a trocar part if one desired to do so-note that the limitation is merely a functional limitation and does not affect the structure of the claimed invention; note also that the trocar port is not positively recited and only recited in the preamble; see also Col. 5 lines 25-36), the laparoscopic applicator comprising: a delivery tube 24 configured for holding the paste (Col. 4 lines 17-33), the delivery tube comprising, at a distal end, a flexible distal section that is bendable along its length (Col. 9 lines 59-62); a rigid sheath (i.e., at 14) surrounding at least a part of the delivery tube (Fig. 1A); and an applicator tip (i.e., at 16) connected to the distal end-of the delivery tube (Fig. 1A) and configured for retaining a pressurized paste (Col. 4 lines 1-33).
The device of Edwards is fully capable of having he applicator tip configured for being controllably operated by the external robotic arm by: being spatially manipulated by the external robotic arm, if one desired to do so - note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 2, Edwards discloses the laparoscopic applicator according to claim 1. Edwards also discloses wherein the delivery tube and/or applicator tip has an inner diameter of less than 5 mm (Col. 1 lines 29-57).
Regarding claim 3, Edwards discloses the laparoscopic applicator according to claim 1. Edwards also discloses wherein the applicator tip further comprises at least one valve 50 configured for releasing the paste from the delivery tube upon opening of said valve (Col. 9 lines 41-58), the at least one valve further configured to, in a closed state, retain the pressurized paste in the applicator tip (Col. 9 lines 41-58).
Regarding claim 4, Edwards discloses the laparoscopic applicator according to claim 3. Edwards also discloses wherein the applicator tip further comprises at least one actuator configured to open and/or close the at least one valve (i.e., such as a hemostasis valve and Tuhoy-Bourse valves as disclosed in Col. 9 lines 41-58).
Regarding claim 5, Edwards discloses the laparoscopic applicator according to claim 4. Edwards also discloses wherein the at least one actuator is activated by pulling the actuator along a longitudinal axis of the tube/applicator tip and/or by rotating the actuator around the longitudinal axis (i.e., by rotation such as a hemostasis valve and Tuhoy-Bourse valves as disclosed in Col. 9 lines 41-58).
Regarding claim 6, Edwards discloses the laparoscopic applicator according to claim 4. Edwards also discloses wherein the at least one actuator is configured to, upon activation, send an electrical signal to a pressure source configured to exert a pressure sufficient to dispense the paste from the laparoscopic applicator (Col. 4 lines 17-33).
Regarding claim 8, Edwards discloses the laparoscopic applicator according to claim 1. Edwards also discloses wherein the applicator further comprises at least one fluid source 24 for holding a fluid, said fluid source being in fluid connection with the delivery tube (Fig. 1A).
Regarding claim 9, Edwards discloses the laparoscopic applicator according to claim 8. Edwards also discloses wherein the delivery tube and the at least one fluid source is configured to comprise the same paste, such that the at least one fluid source constitutes a first paste reservoir (Col. 4 lines 1-33).
Regarding claim 10, Edwards discloses the laparoscopic applicator according to claim 9. Edwards also discloses comprising one or more second paste reservoirs, wherein the second paste reservoirs are detachably attached to the first paste reservoir via at least one auxiliary connector element (Col. 4 line 65-Col. 5 line 17).
Regarding claim 11, Edwards discloses the laparoscopic applicator according to claim 8. Edwards also discloses wherein the at least one fluid source is configured to be pressurized.
Regarding claim 12, Edwards discloses the laparoscopic applicator according to claim 1. Edwards also discloses wherein the applicator further comprises at least one pressure source (i.e., plunger as showed in Fig. 1A) configured for applying a pressure to the at least one fluid source and/or configured for applying a pressure to the inside of the delivery tube (Fig. 1A).
Regarding claim 13, Edwards discloses the laparoscopic applicator according to claim 12. Edwards also discloses wherein the at least one pressure source is a drive mechanism selected from the group of: manual piston (Fig. 1A), motorized piston, spring force, and gas pressure.
Regarding claim 14, Edwards discloses a kit of parts comprising: a laparoscopic applicator according to claim 1. Edwards also discloses one or more pressure sources (i.e., plunger of Fig. 1A), and optionally one or more fluid sources.
Regarding claim 15, Edwards discloses a kit of parts comprising: a laparoscopic applicator according to claim 1. Edwards also discloses a driver unit for holding: at least one fluid source for holding a fluid (i.e., the plunger body of 24), said fluid source being in fluid connection with the delivery tube (Fig. 1A); and/or at least one pressure source (i.e., plunger of 24) configured for applying a pressure to the at least one fluid source and/or configured for applying a pressure to the inside of the delivery tube (Fig. 1A).
Regarding claim 16, Edwards discloses the laparoscopic applicator according to claim 2. Edwards also discloses wherein the inner diameter is less than 3 mm or less than 2 mm (Col. 1 lines 29-35).
Regarding claim 17, Edwards discloses the laparoscopic applicator according to claim 3. Edwards also discloses wherein the at least one valve is a pressure-activated valve (Col. 9 lines 41-58).
Regarding claim 18, Edwards discloses the laparoscopic applicator according to claim 6. Edwards also discloses wherein the pressure source is a drive mechanism (i.e., plunger as shown in Fig. 1A).
Regarding claim 21, Edwards discloses the laparoscopic applicator according to claim 1. Edwards also discloses wherein the delivery tube at a proximal end comprises a Luer lock (i.e., at 14) for attaching a syringe.
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.
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Warren (US 20030100824 A1).
Regarding claims 7 and 19, Edwards discloses the laparoscopic applicator according to claim 1. Edwards doesn’t directly disclose wherein the applicator tip further comprises a status indicator, said status indicator configured to indicate the remaining volume of paste in the applicator, wherein the status indicator is in the form of light diodes.
In the same field of endeavor, namely architecture tool and methods of use Warren discloses a similar device wherein the applicator tip further comprises a status indicator, said status indicator configured to indicate the remaining volume of paste in the applicator (para. [0239] at least by tracking time and thereby volume), wherein the status indicator is in the form of light diodes (para. [0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Edwards to have the above limitations for purposes of tracking volume (paras. [0239], [0015]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Mohr (US 20160074117 A1).
Regarding claim 20, Edwards discloses the kit of parts according to claim 15. Edwards doesn’t directly disclose wherein the at least one pressure source is a motor.
In the same field of endeavor, namely medical device with orientable tip for robotically directed laser cutting, Mohr discloses a similar device including a driver unit 820, 830 for holding a fluid (para. [0060], [0068], a pressure source 822, 832, configured to apply pressure (para. [0060]) and also discloses wherein the at least one pressure source is a motor (para. [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Edwards to have a pressure source as a motor for purposes of automatic manipulation of the tool (para. [0038]).
Response to Arguments
Applicant’s arguments with respect to claim 1 has 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.
Note also that Applicant’s arguments rely on language solely recited in preamble recitations in claim 1. When reading the preamble in the context of the entire claim, the recitation “laparoscopic applicator for dispensing a paste comprising a haemostatic agent for stopping a bleeding, at a selected site by means of an external surgical robotic arm, and for being inserted into a trocar port” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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