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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 8/25/2026 is acknowledged.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9, 10, 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schelin et al (US 2022/0233830) in view of Curley (US 8,702,697).
Regarding claim 9, Schelin discloses a method for performing heat therapy of mammalian tissue (abstract), the method comprising: a) inserting an injection tube extending to a hollow tip in a selected position in the mammalian tissue (page 2, para. 0030); b) injecting a liquid including at least one anesthetic and adrenaline into the mammalian tissue (page 2, para. 0030).
Claim 9 further calls for the fluid to be heated to a temperature of at least 37° C, and for the fluid to be injected through the injection tube and through a plurality of openings below an edge of the hollow tip. Schelin teaches providing heat treatment to the tissue, but fails to disclose that the fluid is heated. Curley teaches a method of treating a tissue wherein the heat therapy is provided by heating the fluid delivered to the tissue to at least 37° C thereby allowing a greater volume of tissue to be heat treated as compared to heating with an electrode and to provide better control of the therapeutic area (col. 1, lines 62-67; col. 2, line 54). 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 method of Schelin to include the step of heating the fluid to at least 37° C as taught by Curley to provide improved heat treatment to the tissue.
Curley further teaches that the heated fluid is delivered through a plurality of outlets to provide a controllable treatment zone (col. 12, lines 16-22). 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 delivery catheter of Schelin to include a plurality of openings as taught by Curley to provide a controllable zone of heat treatment to the tissue.
Regarding claim 10, Schelin further discloses the steps of c) axially displacing the hollow tip to another selected position in the mammalian tissue (page 3, para. 0042); d) injecting the liquid including at least one anesthetic and adrenaline through the injection tube into the mammalian tissue (page 3, para. 0042); and e) repeating steps c) and d) at least twice (page 3, para. 0044).
As discussed above with regard to claim 9, claim 10 repeats the limitations of the fluid being heated to a temperature of at least 37° C and the fluid being delivered through the plurality of openings below the edge of the hollow tip. Curley teaches the modifications to the device of Schelin to include these steps as discussed above with regard to claim 9. Since claim 10 further calls for repetition of those steps, the same teachings apply.
Regarding claim 12, Curley further teaches the steps of injecting saline (saline is a sterile sodium chloride solution) heated to a temperature of at least 39° C through the injection tube and through openings in the hollow tip into the mammalian tissue (col. 11, lines 26-33). Curley further teaches that the method includes delivering saline to the tissue as the second fluid (col. 2, lines 44-50) and therefore would be delivered after steps a) and b) taught by Schelin in view of Curley as discussed above. Curley teaches that the saline distributes the heat to the tissue and prevents desiccation of the tissue. Therefore, 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 method of Schelin to include the step of delivering saline at the treatment temperature after delivering of the first fluid as taught by Curley to provide controlled heat therapy and prevent desiccation of the tissue.
Regarding claim 13, Schelin discloses that the mammalian tissue is prostate tissue (abstract), the method further comprising: a) inserting a catheter through the urethra to a position where an end tip and a ballon of the catheter are positioned inside the bladder (page 2, para. 0028); b) inflating the ballon and securing the ballon against the bladder neck (page 2, para. 0028); c) displacing the injection tube inside the catheter (page 2, para. 0032); d) extending the injection tube through an outlet opening of the catheter and inserting the injection tube into the prostate (page 2, para. 0032); and e) injecting the liquid including at least one anesthetic and adrenaline through the injection tube and through the plurality of openings below the edge of the hollow tip into the prostate tissue (page 2, para. 0030).
Claim 13 further calls for the step of providing the fluid heated to a temperature of at least 37° C and delivering the fluid through the plurality of openings below the edge of the hollow tip. Curley teaches these steps as discussed above with regard to claim 9. 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 method of Schelin to include the step of heating the fluid to at least 37° C as taught by Curley to provide improved heat treatment to the tissue. And 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 delivery catheter of Schelin to include a plurality of openings as taught by Curley to provide a controllable zone of heat treatment to the tissue.
Regarding claim 14, Schelin discloses the steps of f) axially displacing the hollow tip to another selected position in the prostate tissue; and g) repeating step e) at least once (page 3, para. 0044).
Regarding claim 15, Schelin discloses that the device is relocated to four different locations to treat different quadrants of the prostate (page 3, para. 0044). Schelin does not specifically disclose rotating the catheter; however, the prostate surrounds the urethra and therefore it is understood that accessing the various quadrants of the prostate would require rotation of the treatment catheter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of moving the catheter to access four quadrants of the prostate would require rotation of the catheter by at least 15 degrees. Schelin in view of Curley teach the remainder of the recited steps as discussed in detail above with regard to claim 9.
Regarding claim 16, Schelin discloses the steps of axially displacing the catheter and repeating the steps (page 3, para. 0042, 0044).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schelin in view of Curley as applied to claim 9 above, and further in view of Bolmsjo et al (ES 2282159 T3). For ease of discussion, see machine translation provided herewith.
Regarding claim 11. Schelin discloses that the liquid is a solution of Mepivacaine Adrenaline (page 2, para. 0033), but fails to disclose Mepivacaine Adrenaline 0.5%. Bolmsjo teaches treatment of the prostate using mepivacaine (carbocaine) adrenaline 0.5% results in procedures requiring less pawer, shorter treatment periods and an index of lower blood flow (top of page 4). 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 method of Schelin using mepivacaine adrenaline to include the use of mepivacaine adrenalin 0.5% as taught by Blomsjo because this formulation provides good results when used in the prostate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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