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 .
Acknowledgment
Claims 1, 7-9, 12-14, 18 are amended and filed on 10/15/2025.
Claim 11 is cancelled and claims 19-21 are newly added,
Specification’s objection in the action mailed on 7/28/2025 is withdrawn due to the amendment to the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 17 of claim 1 “ a patient” should read as “ the patient” (see line 9 of claim 1).
Appropriate correction is required.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-136, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. US 11938289 B2 in view of Hoey et al. (US. 20150157384A1) (“Hoey”). Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim1 of the current application discloses a method for performing a prostate surgical or medical treatment (clm 1 of patent, Col. 7, line 59 up to Col.8, line 31) comprising: - arranging a catheter comprising - an introduction unit with a top (clm 1 of patent, Col. 7, line 59 up to Col.8, line 31); - a balloon stopper unit (clm 1 of patent, Col. 7, line 59 up to Col.8, line 31); said catheter also comprising - an injection connection (clm 1 of patent, Col. 7, line 59 up to Col.8, line 31); - a drainage outlet (clm 1 of patent, Col. 7, line 59 up to Col.8, line 31); inside of a urethra of a patient and anchored against the bladder neck of the patient subsequent to the filling of the balloon stopper unit with a fluid when the balloon stopper unit is arranged inside of the bladder of a patient (clm 1 of patent, Col. 7, line 59 up to Col.8, line 31); said method also comprising - injecting at least one anesthetic agent to the prostate via the injection tube and said at least one outflow opening of the needle at an intended position of the prostate and a needle (tube, clm 1 of patent, Col. 7, line 59 up to Col.8, line 31), but it fails to disclose that the needle has at least one outflow opening being provided in a radial direction from the needle (also clm 2-3). However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) comprises at least one outflow opening (108s, ¶0041) being provided in a radial direction from the needle (Fig. 2) and the injection is via the injection tube and said at least one outflow opening of the needle at an intended position of the prostate (¶0037, ¶0041). Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of claim 1 of the patent so that at least one outflow opening being provided in a radial direction from the needle and the injection is via the injection tube and said at least one outflow opening of the needle at an intended position of the prostate as taught by Hoey for the purpose of delivering a desired agent to treat the prostate to the target tissue (Hoey, ¶0037).
Also, the claims 2-13, 18 of the current application can be doing in claims 1-13 of the patent such as claims 2-3 ( patent claim 1 and Hoey, ¶0037), claim 4 ( Patent claim 1), claim 5 ( Patent claim 1), claim 6 (Patent claim 6), claim 7 (Patent claim 7), claim 8 (Patent claim 7), claim 9 (Patent claim 4), claim 10 (Patent claim 4), claim 11 (Patent claim 8), claim 12 (Patent claim 9), claim 13 (Patent claim 2), claim 18 ( Patent claim 7).
The current claim 1 is border than claim 1 of the patent ( claim 1 of the patent require steps of injection to the half of the prostate and then removing and changing the position of the catheter).
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.
Claim(s) 1-5, 12, 14-16, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolmsjo et al. (US. 20050124852A1) (“Bolmsjo”) in view of Hoey et al. (US.20150157384A1) (“Hoey”).
Re Claim 1, Bolmsjo discloses a method for performing a prostate surgical or medical treatment (¶0003, ¶0028, Figs. 1-6), said method comprising: - arranging a catheter (10, Figs. 1-6) comprising - an introduction unit (top portion of 10 include top 11 and drainage hole 17) with a top (11), said introduction unit also comprising a drainage lumen hole (17) for drainage of a urinary bladder (17 is connected to 18, ¶0023); - a balloon stopper unit (14) in connection with and thus possible to fill via a balloon inflation connection (15, ¶0022) and balloon filling tube arranged inside of the introduction unit (tube has lumen 15, 16, Figs. 1-2, ¶0022), wherein filling of the balloon stopper unit with a fluid is intended when the balloon stopper unit is arranged inside of the bladder of a patient to provide for a stopper function of the balloon stopper unit against the bladder neck of the patient (¶0009, ¶0022, Figs. 1-3); an injection connection connected to an injection tube (20, ¶0024) arranged inside of the introduction unit (Figs. 5-6), which injection tube extends in a needle (20, ¶0030) arranged to be provided to extend from the introduction unit (Fig. 3); - a drainage outlet (24 , ¶0023, ¶0026); inserting the balloon stopper unit inside of a urethra of a patient and anchoring the balloon stopper unit against the bladder neck of the patient (Fig. 1, ¶0033) by filling the balloon stopper unit with a fluid ( Fig. 1, ¶0033, abstract); and - injecting at least one anesthetic agent (¶0003) and opening of the needle at an intended position of the prostate by using a syringe (22) connectable to the injection connection of the catheter (25, injecting bulking agent by the tube 20 in different positions ¶0031), but it fails to disclose that the needle has at least one outflow opening being provided in a radial direction and the injection is via the injection tube and said at least one outflow opening of the needle at an intended position of the prostate.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) comprises at least one outflow opening (108s, ¶0041) being provided in a radial direction from the needle (Fig. 2) and the injection is via the injection tube and said at least one outflow opening of the needle at an intended position of the prostate (¶0037, ¶0041).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the needle has at least one outflow opening being provided in a radial direction and the injection is via the injection tube and said at least one outflow opening of the needle at an intended position of the prostate as taught by Hoey for the purpose of delivering a desired agent to treat the prostate to the target tissue (Hoey, ¶0037).
Re Claim 2, Bolmsjo fails to disclose wherein the needle has at least two outflow openings being provided in radial directions from the needle.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) comprises the needle has at least two outflow openings being provided in radial directions from the needle (108s, ¶0041).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the needle has at least two outflow openings being provided in radial directions from the needle as taught by Hoey for the purpose of using a needle that it is capable to deliver a fluid to the tissue in a perpendicular direction to the shaft direction (Hoey, ¶0038).
Re Claim 3, Bolmsjo fails to disclose wherein said at least two outflow openings are provided on opposite sides of the needle.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) comprises the needle has at least two outflow openings are provided on opposite sides of the needle (108s, ¶0041).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that said at least two outflow openings are provided on opposite sides of the needle as taught by Hoey for the purpose of using a needle that it is capable to deliver a fluid to the tissue in a perpendicular direction to the shaft direction (Hoey, ¶0038).
Re Claim 4, Bolmsjo fails to disclose wherein the method involves injecting at least one anesthetic agent and adrenaline.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) and wherein the method involves injecting at least one anesthetic agent and adrenaline (¶0037).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the method involves injecting at least one anesthetic agent and adrenaline as taught by Hoey for the purpose of delivering a desired agent to treat the prostate to the target tissue (Hoey, ¶0037).
Re Claim 5, the modified Bolmsjo discloses wherein the method involves changing the position of the needle in the prostate (¶0031, Bolmsjo) to enable for injection of at least one anesthetic agent and adrenaline at different positions in the prostate (Hoey, ¶0037).
Re Claim 12, Bolmsjo fails to disclose wherein the method involves means for locating a tip of the needle, said means for locating is an external means or internal means to be injected through the needle.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) and wherein the method involves means for locating a tip of the needle (¶0052, ¶0064) and said means for locating is an external means, preferably an ultrasound device or a CT (computed tomography) device, or internal means to be injected through the needle, preferably nanoparticles (¶0052, ¶0064).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the method involves means for locating a tip of the needle, said means for locating is an external means or internal means to be injected through the needle as taught by Hoey for the purpose of delivering a desired agent to treat the prostate to the target tissue (Hoey, ¶0037).
Re Claim 14, Bolmsjo discloses a kit (Figs.1-6) comprising - a catheter (10) comprising - an introduction unit (top portion of 10 include 11) with a top (11), said introduction unit also comprising a drainage lumen hole (17, ¶0023) for drainage of a urinary bladder (¶0023); - a balloon stopper unit (14) in connection with and thus possible to fill via a balloon inflation connection (15, ¶0022) and balloon filling tube arranged inside of the introduction unit (15, 16, ¶0022), wherein filling of the balloon stopper unit with a fluid is intended when the balloon stopper unit is arranged inside of the bladder of a patient to provide for a stopper function of the balloon stopper unit against the bladder neck of the patient (¶0009, ¶0022, Figs. 1-3); - an injection connection connected to an injection tube (13, 20) arranged inside of the introduction unit (Figs. 5-6), which injection tube extends in a needle (20) arranged to be provided to extend from the introduction unit (Fig. 1); - a drainage outlet (24);- at least one or more syringe(s) connectable to the injection connection of the catheter (22, or 26) and further disclose injected the tissue by local anesthesia (¶0003), but it fails to disclose the needle has at least one outflow opening being provided in a radial direction from the needle and at least one or more syringe(s) containing at least one anesthetic agent.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) comprises at least one outflow opening (108s, ¶0041) being provided in a radial direction from the needle (Fig. 2) and the injection source is connectable to catheter (Fig. 1) and said at least one outflow opening of the needle at an intended position of the prostate (¶0037, ¶0041).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit of Bolmsjo so that the needle has at least one outflow opening being provided in a radial direction from the needle and at least one or more syringe(s) containing at least one anesthetic agent as taught by Hoey for the purpose of delivering a desired agent to treat the prostate to the target tissue (Hoey, ¶0037).
Re Claim 15, Bolmsjo fails to disclose wherein the needle has at least two outflow openings being provided in radial directions from the needle.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) comprises the needle has at least two outflow openings being provided in radial directions from the needle (108s, ¶0041).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit of Bolmsjo so that the needle has at least two outflow openings being provided in radial directions from the needle as taught by Hoey for the purpose of using a needle that it is capable to deliver a fluid to the tissue in a perpendicular direction to the shaft direction (Hoey, ¶0038).
Re Claim 16, Bolmsjo fails to disclose wherein said at least two outflow openings are provided on opposite sides of the needle.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) comprises the needle has at least two outflow openings are provided on opposite sides of the needle (108s, ¶0041).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit of Bolmsjo so that said at least two outflow openings are provided on opposite sides of the needle as taught by Hoey for the purpose of using a needle that it is capable to deliver a fluid to the tissue in a perpendicular direction to the shaft direction (Hoey, ¶0038).
Re Claim 21, Bolmsjo fails to disclose wherein the method involves wherein said external means includes an ultrasound device or a CT (computed tomography) device..
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the catheter unit (102) comprising a needle (needle 106, ¶0038) and wherein the method involves means for locating a tip of the needle (¶0052, ¶0064) and wherein said external means includes an ultrasound device or a CT (computed tomography) device (¶0052, ¶0064).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that said external means includes an ultrasound device or a CT (computed tomography) device as taught by Hoey for the purpose of delivering a desired agent to treat the prostate to the target tissue (Hoey, ¶0037).
Claim(s) 6, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolmsjo in view of Hoey and in view of Kalt et al. (US. 20200345976A1)(“Kalt” ) and further in view of Bolmsjo et al. (US. 20050059929A1)(“ Bolmsjo I”).
Re Claim 6, the modified Bolmsjo discloses wherein the method involves injecting at least one anesthetic agent to one first half of the prostate (right lobe, Hoey, ¶0037, ¶0044), then removing the catheter from the patient (¶0032, Bolmsjo discloses that the catheter can be removed after injection), then inserting the catheter again into the patient (Bolmsjo discloses inserting the catheter for another treatment ¶0030 of the prostate) and injecting at least one anesthetic agent to the second half of the prostate (right lobe, Hoey, ¶0037, ¶0044), and Bolmsjo further discloses that treatment can be reposition the catheter and remove the catheter after injection (¶0032), but it fails to disclose that the injecting step comprising injecting both least one anesthetic agent and adrenaline to the first half and second half, performing trimming of that first half of the prostate in a transurethral resection of the prostate (TURP) surgical treatment and performing trimming of that second half of the prostate.
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and that the agent which injected to one part is both at least one anesthetic agent and adrenaline and the agent which injected to another part of the prostate is both at least one anesthetic agent and adrenaline (¶0083, anesthetic and adrenergic agonists such as estrogens).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the agent which injected to first part is both at least one anesthetic agent and adrenaline and the agent which injected to second part of the prostate is both at least one anesthetic agent and adrenaline as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Bolmsjo in view of Hoey and Kalt fails to disclose performing trimming of that first half of the prostate in a transurethral resection of the prostate (TURP) surgical treatment and performing trimming of that second half of the prostate.
However, Bolmsjo I discloses a method of treating a prostate ( Fig. 1-9, ¶0038) and wherein catheter unit (20) can be removed (¶0033), and performing trimming of that first half of the prostate in a transurethral resection of the prostate (TURP) surgical treatment and after injection of the second half of the prostate (¶0034), and performing trimming of that second half of the prostate (¶0060)
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that performing trimming of that first half of the prostate in a transurethral resection of the prostate (TURP) surgical treatment and performing trimming of that second half of the prostate as taught by Bolmsjo I for the purpose of removal of affected tissue (Bolmsjo I, ¶0060, note, the catheter can be removed and treat the affected area and then repeated to a second treatment for a second affected area ¶0060).
Re Claim 8, Bolmsjo fails to disclose wherein the method involves a sequence of injecting both at least one anesthetic agent and adrenaline to a volume of the prostate and then performing trimming in a transurethral resection of the prostate (TURP) surgical treatment or a heat treatment of a corresponding surface of the prostate within a time frame of maximum 25 minutes, and then performing yet another similar sequence to another volume of the prostate.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the method involves a sequence of injecting at least one anesthetic agent to a volume of the prostate (¶0037) and then performing trimming in a transurethral resection of the prostate (TURP) surgical treatment or a heat treatment of a corresponding surface of the prostate within a time frame of maximum 25 minutes, preferably maximum 20 minutes, more preferably maximum 15 minutes, and then performing yet another similar sequence to another volume of the prostate ( then thermal energy 1-3 minute to each lobe)
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the method involves a sequence of injecting at least one anesthetic agent to a volume of the prostate and then performing trimming in a transurethral resection of the prostate (TURP) surgical treatment or a heat treatment of a corresponding surface of the prostate within a time frame of maximum 25 minutes and then performing yet another similar sequence to another volume of the prostate as taught by Hoey for the purpose of ablating the prostate tissue (Hoey, ¶0012).
The modified Bolmsjo fails to disclose that the agent which injected to a volume of the prostate is both at least one anesthetic agent and adrenaline and the agent which injected to another volume of the prostate of is both at least one anesthetic agent and adrenaline.
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and that the agent which injected to a volume of the prostate is both at least one anesthetic agent and adrenaline and the agent which injected to another volume of the prostate of is both at least one anesthetic agent and adrenaline (¶0083, anesthetic and adrenergic agonists such as estrogens).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the agent which injected to first part is both at least one anesthetic agent and adrenaline and the agent which injected to second part of the prostate is both at least one anesthetic agent and adrenaline as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Claim(s) 7, 9-10, 13, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolmsjo in view of Hoey and further in view of Kalt et al. (US. 20200345976A1)(“Kalt”).
Re Claim 7, Bolmsjo discloses injecting agent to one part of the prostate (¶0031) and then in injecting the agent to another part of the prostate (¶0031, by rotating the catheter), but it fails to disclose that injected agent to one part of the prostate is both at least one anesthetic agent and adrenaline and then supplying heat to the surface of the prostate at a corresponding position to that part of the prostate, then injected agent to another part of the prostate both at least one anesthetic agent and adrenaline and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the agent injected is anesthetic to one part of the prostate (¶0037, ¶0045) and then supplying heat to the surface of the prostate at a corresponding position to that part of the prostate (¶0045), then injected agent to another part of the prostate at least one anesthetic agent (¶0037) and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate (¶0045).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that inject the agent to the one part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that part of the prostate, then inject the agent to another part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate as taught by Hoey for the purpose of using a needle that it is capable to deliver a fluid to the tissue in a perpendicular direction to the shaft direction (Hoey, ¶0038).
The modified Bolmsjo fails to disclose that the agent which injected to one part is both at least one anesthetic agent and adrenaline and the agent which injected to another part of the prostate is both at least one anesthetic agent and adrenaline.
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and that the agent which injected to one part is both at least one anesthetic agent and adrenaline and the agent which injected to another part of the prostate is both at least one anesthetic agent and adrenaline (¶0083, anesthetic and adrenergic agonists such as estrogens).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the agent which injected to one part is both at least one anesthetic agent and adrenaline and the agent which injected to another part of the prostate is both at least one anesthetic agent and adrenaline as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 9, Bolmsjo discloses injecting an agent sequentially to different parts of the prostate (¶0032), but it fails to disclose wherein the method involves injecting at least adrenaline.
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and that the agent which injected to one part is both at least one anesthetic agent and adrenaline and the agent which injected to another part of the prostate is both at least one anesthetic agent and adrenaline (¶0083, anesthetic and adrenergic agonists such as estrogens).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that wherein the method involves injecting at least adrenaline as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 10, the modified Bolmsjo discloses wherein the method involves injecting at least one anesthetic agent to the prostate via the needle (¶0032 of Bolmsjo, Hoey ¶0037), but it injecting adrenaline to the prostate via the needle during at least a first phase of the method, wherein at least the injecting of adrenaline to the prostate is performed sequentially.
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and that the agent which injected to one part is both at least one anesthetic agent and adrenaline and the agent which injected to another part of the prostate is both at least one anesthetic agent and adrenaline (¶0083, anesthetic and adrenergic agonists such as estrogens).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that injecting adrenaline to the prostate via the needle during at least a first phase of the method, wherein at least the injecting of adrenaline to the prostate is performed sequentially as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 13, Bolmsjo fails to disclose wherein the method also involves injecting at least one of adrenaline or one or more cytostatic agents to the prostate
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and that the agent which injected to one part is both at least one anesthetic agent and adrenaline and the agent which injected to another part of the prostate is both at least one anesthetic agent and adrenaline (¶0083, anesthetic and adrenergic agonists such as estrogens).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the method also involves injecting at least one of adrenaline or one or more cytostatic agents to the prostate as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 17, Bolmsjo disclosed wherein said at least one or more syringe(s) (22, 26, Fig. 2) connectable to the injection connection of the catheter (Fig. 2), but it fails to disclose that syringe contains adrenaline.
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and that the agent which injected to one part is both at least one anesthetic agent and adrenaline and the agent which injected to another part of the prostate is both at least one anesthetic agent and adrenaline (¶0083, anesthetic and adrenergic agonists such as estrogens).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit of Bolmsjo so that syringe contains adrenaline as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 18, Bolmsjo discloses injecting an agent to a volume of prostate (¶0032) and injecting an agent to another volume of prostate (¶0032), but if fails to specifically disclose wherein the method involves a sequence of injecting both at least one anesthetic agent and adrenaline to a volume of the prostate and then performing trimming in a transurethral resection of the prostate (TURP) surgical treatment or a heat treatment of a corresponding surface of the prostate within a time frame of maximum 25 minutes and then performing yet another similar sequence to another volume of the prostate.
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the method involves a sequence of injecting at least one anesthetic agent to a volume of the prostate (¶0037) and then performing trimming in a transurethral resection of the prostate (TURP) surgical treatment or a heat treatment of a corresponding surface of the prostate within a time frame of maximum 25 minutes, preferably maximum 20 minutes, more preferably maximum 15 minutes, and then performing yet another similar sequence to another volume of the prostate ( then thermal energy 1-3 minute to each lobe)
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that wherein the method involves injecting agent to a volume of the prostate and then performing trimming in a transurethral resection of the prostate (TURP) surgical treatment or a heat treatment of a corresponding surface of the prostate within a time frame of maximum 25 minutes and then performing yet another similar sequence to another volume of the prostate as taught by Hoey for the purpose of ablating the prostate tissue (Hoey, ¶0012).
The modified Bolmsjo fails to disclose that the agent which injected to a volume of the prostate is both at least one anesthetic agent and adrenaline and the agent which injected to another volume of the prostate of is both at least one anesthetic agent and adrenaline.
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and that the agent which injected to a volume of the prostate is both at least one anesthetic agent and adrenaline and the agent which injected to another volume of the prostate of is both at least one anesthetic agent and adrenaline (¶0083, anesthetic and adrenergic agonists such as estrogens).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the agent which injected to a volume of prostate is both at least one anesthetic agent and adrenaline and the agent which injected to another volume of the prostate is both at least one anesthetic agent and adrenaline as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 19, Bolmsjo discloses injecting an agent to a volume of prostate (¶0032) and injecting an agent to another volume of prostate (¶0032), but if fails to specifically disclose the method involves injecting both at least one anesthetic agent and adrenaline to one part of the prostate, then supplying heat to the surface of the prostate at a corresponding position to that part of the prostate, then injecting both at least one anesthetic agent and adrenaline to another part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate by removing the catheter from the patient after the injecting of at least one anesthetic agent and adrenaline and inserting another catheter for enabling the supplying of heat via one or more heating elements
However, Hoey discloses a method of treating a prostate ( Fig. 1-2, ¶0038) and wherein the method involves a sequence of injecting at least one anesthetic agent to a volume of the prostate (¶0037) and then supplying heat to the surface of the prostate at a corresponding position to that part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate ( then thermal energy 1-3 minute to lobe), then injecting at least one anesthetic agent to a volume of the prostate (¶0037) and then supplying heat to the surface of the prostate at a corresponding position to that part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate (then thermal energy 1-3 minute to another lobe),
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that method involves injecting agent to one part of the prostate, then supplying heat to the surface of the prostate at a corresponding position to that part of the prostate, then injecting agent to another part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate by removing the catheter from the patient after the injecting of at least one anesthetic agent and adrenaline and inserting another catheter for enabling the supplying of heat via one or more heating elements as taught by Hoey for the purpose of ablating the prostate tissue (Hoey, ¶0012).
The modified Bolmsjo fails to disclose that injecting both at least one anesthetic agent and adrenaline to another part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate by removing the catheter from the patient after the injecting of at least one anesthetic agent and adrenaline and inserting another catheter for enabling the supplying of heat via one or more heating elements.
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and injecting both at least one anesthetic agent and adrenaline to another part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate by removing the catheter from the patient after the injecting of at least one anesthetic agent and adrenaline and inserting another catheter for enabling the supplying of heat via one or more heating elements (¶0083, anesthetic and adrenergic agonists such as estrogens).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that injecting both at least one anesthetic agent and adrenaline to another part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate by removing the catheter from the patient after the injecting of at least one anesthetic agent and adrenaline and inserting another catheter for enabling the supplying of heat via one or more heating elements as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 20, the modified Bolmsjo fails to disclose the method involves injecting both at least one anesthetic agent, such as carbocaine, and adrenaline, sequentially to different parts of the prostate.
However, Kalt discloses a method of treating a prostate ( Fig. 1a, ¶0078) and the method involves injecting both at least one anesthetic agent, such as carbocaine, and adrenaline, sequentially to different parts of the prostate (¶0073, ¶077).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Bolmsjo so that the method involves injecting both at least one anesthetic agent, such as carbocaine, and adrenaline, sequentially to different parts of the prostate as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive.
The applicant argues with regards to claim 1 and 14 that provided art fails to read on the limitation “a needle has at least two opposite outflow opening”. This is found not persuasive as the needle of Hoey in Fig. 2 discloses a needle with two radial outflow openings (106, 108).
The applicant argues that Hoey’s device has openings that are not used for a liquid. This is found not persuasive as “a liquid” is not claimed. However, the two outflow openings are capable to inject a fluid.
The applicant argues that the art fails to inject at least one anesthetic agent from the needle. This is found not persuasive as Hoey’s device inject an anesthetic agent from the opening ( see ¶0037).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783