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 .
Terminal Disclaimer
The terminal disclaimer filed on 3/4/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11938289 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Acknowledgment
Specification was amended and filed on 3/4/2026.
Claims 1, 5-7, 9-11, 16, 19 and 23 are amended and filed on 3/4/2026.
Claims 2-4, 17-18, 21 are canceled.
The objection to the specification in the action mailed on 12/29/2025 is withdrawn due to the specification’s amendment.
The objection to the claims and 112 rejection is withdrawn due to the claims’ amendment .
The double patenting rejection is withdrawn due to terminal declaimer.
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, 5-7, 9, 11-16, 19-20, 22-23 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”) and further in view of Kalt et al. (US. 20200345976A1)(“Kalt”).
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 a 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 (13, 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 the patient and anchoring the balloon stopper unit against a bladder neck of the patient (Fig. 1) by filling the balloon stopper unit with the fluid ( Fig. 1, ¶0009, ¶0022, abstract); and - injecting at least one anesthetic agent and/or antibiotic agent (¶0003) to the prostate via injection tube and the needle (injecting bulking agent by the tube 20 in different positions ¶0031), but it fails to disclose that the needle comprises 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 and wherein aid at least one outflow opening comprises at least two outflow openings being provided in radial directions from the needle, wherein said at least two outflow openings are provided on opposite sides of the needle and 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) comprises at least one outflow opening (108s, ¶0041) being provided in a radial direction from the needle (Fig. 2) and the needle (needle 106, ¶0038) comprises the needle has at least two outflow openings being provided in radial directions from the needle (108s, ¶0041) and wherein the method involves injecting at least one anesthetic agent (¶0037) 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 comprises 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 and wherein aid at least one outflow opening comprises at least two outflow openings being provided in radial directions from the needle, wherein said at least two outflow openings are provided on opposite sides of the needle and wherein the method involves injecting 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).
The modified Bolmsjo fails to disclose injecting 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 adrenaline is an adrenergic agonists).
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 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 5, the modified Bolmsjo discloses wherein the method involves changing a 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 and Kalt ¶0083).
Re Claim 6, Bolmsjo fails to disclose wherein the method involves injecting at least one anesthetic agent and at least antibiotic 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) and wherein the method involves injecting at least one anesthetic agent and antibiotic agent (¶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 at least antibiotic 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 7, 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 (¶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 as taught by Hoey for the purpose of delivering a desired agent to treat the prostate to the target tissue (Hoey, ¶0037).
The modified Bolmsjo fails to disclose injecting 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 adrenaline is an adrenergic agonists).
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 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 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).
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 11, 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).
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 is adrenaline which injected to different parts of the prostate as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 12, 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 involves means for locating a tip 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) and wherein the method involves means for locating a tip of the needle (¶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 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 fails to disclose wherein 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, or internal means to be injected through the needle (¶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 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 15, Bolmsjo fails to disclose wherein the method also involves injecting adrenaline and/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 adrenaline and/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 16, 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), wherein the needle has at least one outflow opening (opening of 20, 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 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 and/or at least one antibiotic agent. wherein the needle has at least two outflow openings being provided in radial directions from the needle, wherein said at least two outflow openings are provided on opposite sides of the needle and said at least one or more syringe(s) connectable to the injection connection of the catheter also contains 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) comprises at least one outflow opening (108s, ¶0041) being provided in a radial direction from the needle (Fig. 2) and are provided on opposite sides of the (Fig. 1-2) 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), and the one or more vials ( source of the agent, ¶0037) containing at least one of the following: an anesthetic agent, an antibiotic agent, botulinum toxin (¶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 kit of Bolmsjo so that the 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 and/or at least one antibiotic agent, wherein the needle has at least two outflow openings being provided in radial directions from the needle, wherein said at least two outflow openings are provided on opposite sides of the needle as taught by Hoey for the purpose of delivering a desired agent to treat the prostate to the target tissue (Hoey, ¶0037).
The modified Bolmsjo fails to disclose said at least one or more syringe(s) connectable to the injection connection of the catheter also 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 adrenaline is an adrenergic agonists).
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 one or more syringe(s) connectable to the injection connection of the catheter also contains adrenaline as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 19, Bolmsjo discloses wherein said kit comprises also one or more vials or flasks (syringe 22), but it fails to disclose that the one or more vials containing at least one of the following: an anesthetic agent, adrenaline, an antibiotic agent, botulinum toxin, a corticosteroid, an anti-inflammatory agent, or a combination thereof, which are intended to be contained in said at least one or more syringe(s) connectable to the injection connection of the catheter.
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 one or more vials ( agent source, ¶0037) containing at least one of the following: an anesthetic agent, adrenaline, an antibiotic agent, botulinum toxin, a corticosteroid, an anti-inflammatory agent, or a combination thereof, which are intended to be contained in said at least one or more syringe(s) connectable to the injection connection of the catheter, preferably several vials or flasks of which there is contained a combination of an anesthetic agent, adrenaline, an antibiotic agent, botulinum toxin, a corticosteroid, an anti-inflammatory agent, or a combination thereof (108s, ¶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 kit of Bolmsjo so that the one or more vials containing at least one of the following: an anesthetic agent, adrenaline, an antibiotic agent, botulinum toxin, a corticosteroid, an anti-inflammatory agent, or a combination thereof, which are intended to be contained in said at least one or more syringe(s) connectable to the injection connection of the catheter 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 20, Bolmsjo discloses wherein said kit comprises also one or more vials or flasks ( syringe 22), but it fails to discloses wherein said kit comprises at least individual flasks or vials for at least one anesthetic agent, adrenaline, and at least one antibiotic agent, which are intended to be contained in said at least one or more syringe(s) connectable to the injection connection of the catheter.
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 wherein said kit comprises at least individual flasks or vials for at least one anesthetic agent, and at least one antibiotic agent, which are intended to be contained in said at least one or more syringe(s) connectable to the injection connection of the catheter 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 at least individual flasks or vials for 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 adrenaline is an adrenergic agonists).
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 at least individual flasks or vials for adrenaline as taught by Kalt for the purpose of using a selected drug for specific treatment (Kalt, ¶0083).
Re Claim 22, Bolmsjo discloses wherein the catheter comprises an introduction unit with a top (close to 11), wherein the top comprises a tiemann tip (11, Fig. 1).
Re Claim 23, 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 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).
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).
Claim(s) 8, 10 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 8, 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).
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 10, 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.
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 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).
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).
Response to Arguments
Applicant's arguments filed 3/4/2026 have been fully considered but they are not persuasive.
The applicant argues with regards to claims 1 and 16 that the applied art fails to discloses a needle with at least two outflow openings provided on opposite side of the needle and injecting adrenaline. This is found not persuasive as Hoey discloses a needle 106 has openings 108 on opposite side of the needle as claimed see Fig. 1-2 of Hoey and Kalt disclose that the agent can be adrenaline which is adrenergic agonists see ¶0083 of Kalt.
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).
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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.
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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