DETAILED ACTION
This action is pursuant to the claims filed on 06/16/2026. Claims 14, 16-17, 20 and 48-49 are pending. A first action on the merits of claims 14, 16-17, 20 and 48-49 is as follows.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/16/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2026, 02/23/2026, 04/15/2026, 05/26/2026, 06/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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) 14, 16-17, 20, and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey (U.S. PGPub No. 2018/0168711) in view of To (U.S. Patent No. 10,667,855).
Regarding claim 14, Hoey teaches A method of treating a prostate of a patient, comprising the steps of: inserting a shaft of a therapy device transurethrally into the patient (Fig 12, transurethral delivery device); advancing a therapy needle from the shaft, through a prostatic urethra of the patient, and into the prostate of the patient (Fig 12 and [0096] disclosing advancing needle through urethra and into prostate); as the therapy needle is advancing, measuring a sensed parameter of prostate tissue with a sensor disposed on the therapy needle ([0096] tissue identification is made with sensor based on sensed capacitance); determining that the therapy needle has contacted a prostatic capsule based on the sensed parameter ([0091-0092] disclosing safety feature that alerts a user of a needle blockage if, for example, the prostatic capsule is being impinged by the needle); and automatically stopping advancing the therapy needle upon determining that the prostatic capsule is contacted ([0091] disclosing preventing the needle from advancing if blockage is determined, [0092] disclosing this embodiment as “automatic”).
Hoey fails to explicitly teach wherein the sensed parameter is a measured electrical impedance of prostate tissue as the therapy needle advances and determining that the therapy needle has contacted a prostatic capsule based on the electrical impedance.
In related prior art, To teaches a similar method wherein as the therapy needle is advancing, measuring an electrical impedance of prostate tissue with a sensor disposed on the therapy needle (Col 19 line 36 – Col 20 line 9; “Impedance can be monitored in the navigation of the systems taught herein, for example, to monitor the position of the needles and/or coils and/or electrodes as each of them are advanced into a subject”); determining that the therapy needle has contacted a prostatic capsule based on the electrical impedance (Col 19 line 36 – Col 20 line 9; “One of skill will appreciate that there is value in this ability to navigate device components, particularly in knowing where you are in the tissue, as this knowledge may help in avoiding critical structures (nervous tissue, urethra, bowel, exiting prostate capsule unintentionally)” disclosing ability for one of ordinary skill in the art to determine when a prostatic capsule is contacted based on measured impedance). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Hoey in view of To to incorporate the electrical impedance sensor on the needle to measure electrical impedance of prostate tissue as the therapy needle advances to determine and automatically stop advancement of the needle upon determined contact with the prostatic capsule to arrive at the method of claim 14. Doing so would advantageously enable the system and method to monitor the position of the needle during advancement as measured impedance can provide useful feedback as the needle contacts specific tissue types (Col 19 line 36 – Col 20 line 9).
Regarding claim 16, in view of the combination of claim 15 above, To further teaches wherein determining that the therapy needle has contacted the prostatic capsule further comprises detecting an abrupt change in the measured electrical impedance (Col 19 line 46 – Col 20 line 9 disclosing rapid impedance increases and that impedance changes are known by one of ordinary skill in the art to avoid critical structures). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one parameter of Hoey in view of To to incorporate detecting an abrupt change in the measured electrical impedance when the prostatic capsule is detected to arrive at claim 16. Doing so would be a simple substitution of one well-known tissue identification parameter (Hoey [0096] capacitance) for another well tissue identification parameter (To Col 19 line 46 – Col 20 line 8 disclosing impedance) to yield the predictable result of identifying when a critical structure (i.e., prostatic capsule) is contacted (To Col 19 line 46 – Col 20 line 9).
Regarding claim 17, the Hoey/To combination teaches the method of claim 16 as stated above. As stated above Hoey and To both teach that it is well-known in the art that prostatic capsule tissue can differentiated from other tissues based on impedance changes between each tissue type (Hoey [0096]; To Col 19 line 46 to Col 20 line 8). As such, Hoey and To both establish the measured impedance changes are a result effective variable as the change in impedance measurements indicate what type of tissue is adjacent said impedance sensor for identifying said tissue type.
Hoey/To discloses substantially all the limitations of the claim(s) except for the change of more than 25% in the measured impedance. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention as a matter of routine optimization to have further modified Hoey in view of To to incorporate the abrupt change in impedance as an increase of more than 25% to indicate contact with the prostatic capsule, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would have done so with a reasonable expectation of success to detect the presence of the prostatic capsule relative to other tissues. As Hoey has established the result-effective variable of abrupt changes in impedance differentiating between different tissue types ([0096]) such that detecting the prostatic capsule as being an abrupt change of 25% in measured impedance would simply be determining the optimal or workable ranges of said impedance change when contacting the prostatic capsule.
Regarding claim 20, Hoey further teaches delivering vapor from the therapy needle into the prostate ([0091] disclosing vapor delivery needle).
Regarding claim 48, the Hoey/To combination teaches the method of claim 16 as stated above. As stated above Hoey and To both teach that it is well-known in the art that prostatic capsule tissue can differentiated from other tissues based on impedance changes between each tissue type (Hoey [0096]; To Col 19 line 46 to Col 20 line 8). As such, Hoey and To both establish the measured impedance changes are a result effective variable as the change in impedance measurements indicate what type of tissue is adjacent said impedance sensor for identifying said tissue type.
Hoey/To discloses substantially all the limitations of the claim(s) except for the change of 20-50% in the measured impedance. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention as a matter of routine optimization to have further modified Hoey in view of To to incorporate the abrupt change in impedance as a 20-50% abrupt change to indicate contact with the prostatic capsule, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would have done so with a reasonable expectation of success to detect the presence of the prostatic capsule relative to other tissues. As Hoey and To have both established the result-effective variable of abrupt changes in impedance differentiating between different tissue types (Hoey [0096]; To Col 19 line 46 to Col 20 line 9) such that detecting the prostatic capsule as being an abrupt change of 20-50% in measured impedance would simply be determining the optimal or workable ranges of said impedance change when contacting the prostatic capsule.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of To, and in further view of Eggers (U.S. Patent No. 5,630,426).
Regarding claim 49, in view of the combination of claim 16 above,
Hoey/To is silent to the frequency range for measuring the electrical impedance.
In related prior art, Eggers teaches a similar method and system comprising measuring the electrical impedance in a frequency range of about 15-30 kHz (Col 6 lines 1-12, claim 19 of Eggers disclose use of frequency in an overlapping range of 20 KHz to 20 MHz).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoey in view of To and Eggers to use a frequency range of about 15-30 KHz as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant's arguments filed 06/16/2026 have been fully considered but they are not persuasive. Applicant’s amendment to the claims overcome the Hoey reference, but fail to overcome the To reference disclosing use of impedance measurements while advancing a needle through tissue to identify tissue types to guide a procedure as disclosed in column 19 line 36 through column 20 line 39.
Applicant’s arguments on page 7 of the remarks regarding To stating that To fails to disclose that rapid impedance increases of impedance being used to distinguish tissue types. The Examiner respectfully disagrees. The cited portion of To explicitly states “Likewise, since impedance reflects a difference between tissue types, impedance values can be used separately as feedback determine the degree of tissue ablation or necrosis … One of skill will appreciate that there is value in this ability to navigate device components, particularly in knowing where you are in the tissue, as this knowledge may help in avoiding critical structures (nervous tissue, urethra, bowel, exiting prostate capsule unintentionally)” (emphasis added). The above noted disclosure teaches that it is obvious to one of ordinary skill in the art would appreciate that one can use rapid increases in impedance to identify tissue types to avoid critical structures. As such, these arguments are unpersuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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