DETAILED ACTION
This action is pursuant to the claims filed on 11/26/2025. Claims 1-20 are pending. Claims 1-13 are withdrawn. A final action on the merits of claims 14-20 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey (U.S. PGPub No. 2018/0168711).
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); measuring at least one 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 at least one 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 when the prostatic capsule is contacted ([0091] disclosing preventing the needle from advancing if blockage is indicated, [0092] disclosing this embodiment as “automatic”).
Hoey fails to explicitly teach the determination of contact to the prostatic capsule is based on the sensed parameter
However, 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 safety feature of Hoey to incorporate the determination of contact with the prostatic capsule to be based on sensed capacitance to arrive at the method of claim 14. Doing so would advantageously provide for another layer of safety to prevent the undesirable penetration of the prostatic capsule ([0091], [0096]).
Regarding claim 20, Hoey further teaches delivering vapor from the therapy needle into the prostate ([0091] disclosing vapor delivery needle).
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of To (U.S. Patent No. 10,667,855).
Regarding claim 15, Hoey teaches the method of claim 14 as stated above. Hoey teaches wherein the at least one parameter comprises an electrical capacitance of the prostate tissue ([0096]).
Hoey fails to teach wherein the at least one parameter comprises an electrical impedance of the prostate tissue.
In related prior art, To teaches a similar system and method comprising utilizing electrical impedance of tissue to differentiate between tissue types (Col 19 line 46 – Col 20 line 8). 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 the at least one parameter as an impedance parameter to arrive at claim 15. 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 an electrically sensed parameter that is capable of differentiating between tissue types for surgical procedures.
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 8 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 8).
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.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view Silwa (U.S. PGPub No. 2007/0293792).
Regarding claims 18-19, the Hoey combination teaches the method of claim 14 as stated above. Hoey further teaches a safety feature that limits a maximum force the needle can apply to tissue, said force being based on a value that cannot penetrate the prostatic capsule ([0091] said disclosure implicitly teaches that the force required to penetrate prostate tissue is less than that needed to penetrate the capsule).
Hoey fails to teach wherein the at least one parameter comprises a force applied by the prostate tissue to the therapy needle; wherein determining that the therapy needle has contacted the prostatic capsule further comprises detecting a critical force with the sensor.
In related prior art, Silwa teaches a similar system and method wherein the at least one parameter comprises a force applied by the prostate tissue to the therapy needle ([0073] [0119]); wherein determining that the therapy needle has contacted the prostatic capsule further comprises detecting a critical force with the sensor ([0073] increased pressure across prostate compared to adjacent tissue can be detected). 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 of Hoey in view of Silwa to incorporate the force sensor programmed to detect a critical force based on a force resistance of the tissue to determine that the prostatic capsule has been contacted to arrive at claims 18-19. Doing so would advantageously enable the system to detect and verify contact with the prostatic capsule based on a measured force ([0073] disclosing force from prostate can be differentiated from adjacent tissues; Hoey [0091] disclosing force threshold of the prostatic capsule is larger than that of prostate tissue).
Response to Arguments
Applicant’s arguments, see remarks, filed 11/26/2025, with respect to the rejection(s) of claim(s) 14-20 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the Hoey and To references.
While conversations held in the interview dated 11/19/2025 that the amendment of record would appear to overcome the Hoey reference. Unfortunately, further review of the Hoey reference resulted in uncovering a disclosure that the needles of Hoey contact the prostatic capsule and automatically stopping advancement of said needles upon determination of said contact. Paragraph [0091] of Hoey discloses a safety feature in which a blockage is detected when the needle impinges (i.e., contacts) the prostatic capsule to which the needle is prevented from further advancement. Such a recitation provides evidence to make a 103 rejection on claim 14 over Hoey as written above. As such, the arguments are unpersuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 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